Stock: Banco Santander (SAN)News: Past 4 yearsAnnouncementsPress Releases 2024 Mar 22, 2024: Banco Santander Press Release: Availability of the Q1 2024 Memorandum for modelling purposes Availability of the Q1 2024 Memorandum for modelling purposes Paris, France March 22, 2024. Sanofi announced today that its Q1 2024 Memorandum for modelling purposes is available on the "Investors" page of the company's website: First quarter 2024 results (sanofi.com) As for each quarter, Sanofi prepared this document to assist in the financial modelling of the Group's quarterly results. This document includes a reminder on various non-comparable items and exclusivity losses as well as the foreign currency impact and share count. Sanofi's first-quarter 2024 results will be published on April 25, 2024. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Media RelationsSandrine Guendoul|+ 33 6 25 09 14 25 |sandrine.guendoul@sanofi.comNicolas Obrist|+ 33 6 77 21 27 55 |nicolas.obrist@sanofi.comVictor Rouault|+ 33 6 70 93 71 40 |victor.rouault@sanofi.comSally Bain|+ 1 617 834 6026 |sally.bain@sanofi.comEvan Berland | +1 215 432 0234 | evan.berland@sanofi.com Investor RelationsEva Schaefer-Jansen|+ 33 7 86 80 56 39 |eva.schaefer-jansen@sanofi.comArnaud Delepine|+ 33 6 73 69 36 93 | arnaud.delepine@sanofi.comCorentine Driancourt|+ 33 6 40 56 92 21 | corentine.driancourt@sanofi.comFelix Lauscher|+ 1908612 7239 | felix.lauscher@sanofi.comTarik Elgoutni| + 1 617 710 3587 | tarik.elgoutni@sanofi.comNathalie Pham|+ 33 7 85 93 30 17 | nathalie.pham@sanofi.com Sanofi Forward-Looking Statements This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, business transformations, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words expects, anticipates, believes, intends, estimates, plans, potential, outlook, guidance and similar expressions. Although Sanofis management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofis ability to benefit from external growth opportunities, to complete capital markets or other transactions and/or obtain regulatory clearances, risks associated with developing standalone businesses, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and capital market conditions, cost containment initiatives and subsequent changes thereto, and the impact that pandemics, political disruption or armed conflicts or other global crises may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under Risk Factors and Cautionary Statement Regarding Forward-Looking Statements in Sanofis annual report on Form 20-F for the year ended December 31, 2023. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. Attachment Press_Release Source: West Corporation Mar 11, 2024: Banco Santander Press Release: New Phase 2b results for amlitelimab support potential for best-in-class maintenance of response in atopic dermatitis New Phase 2b results for amlitelimab support potential for best-in-class maintenance of response in atopic dermatitis Late-breaking data at AAD show sustained off-drug improvements of AD signs and symptoms with amlitelimab for 28 weeks The safety profile for patients dosed to 52 weeks was consistent with amlitelimab 24 weeks data showing it to be well-tolerated with no new safety concerns identifiedDurability of response supports quarterly dosing currently being investigated in Phase 3 pivotal program Sustained biomarker reduction suggests the modulation of immune response and durable disease control via the blockade of OX40L, a non-T cell depleting mechanism Amlitelimab is one of 12 potential blockbusters in Sanofis leading immunology pipeline, results for a Phase 2 asthma study expected in H2 2024 and three additional Phase 2 study starts expected by year-end Paris, March 11, 2024. Positive results from Part 2 of the investigational amlitelimab Phase 2b study STREAM-AD showed sustained improvement of signs and symptoms for 28 weeks in adults with moderate to severe AD who previously responded to amlitelimab and continued treatment. High responder rates were also observed in participants who were taken off amlitelimab. The safety profile was consistent with Part 1 of the study with amlitelimab being well-tolerated and no new safety concerns identified. These results were presented as part of a late-breaking session at the American Academy of Dermatology (AAD) 2024 Conference in San Diego and support the quarterly (every 12-week) dosing of amlitelimab 250 mg with 500 mg loading dose (LD) now being investigated in a larger Phase 3 clinical program (OCEANA). Professor Stephan Weidinger, M.D, Ph.DDirector, Professor, Chair of Department of Dermatology and Allergy, University Hospital Schleswig-Holstein Despite available treatment options, not all patients with moderate-to-severe atopic dermatitis respond sufficiently to these treatments, and many continue to suffer from skin lesions and symptoms such as persistent itch, which can have a high impact on their day-to-day lives. Results from this part of the study indicate amlitelimabs potential for durable off-drug efficacy which supports the evaluation of a less frequent every 12-week dosing. This could offer an important benefit in the treatment of AD patients. In the second part of the dose-ranging STREAM-AD study, responders to amlitelimab who achieved a 75% improvement in Eczema Area and Severity Index (EASI-75) score and/or Investigator Global Assessment (IGA) score of 0 or 1 during the 24-week treatment period (Part 1) were re-randomized to explore the maintenance of clinical response over an additional 28-week period with continued amlitelimab treatment or amlitelimab withdrawal. Across all dose arms, patients who continued amlitelimab treatment maintained high EASI-75 and/or IGA 0/1, IGA 0/1, and EASI-75 responder rates through 28 weeks. High responder rates were also demonstrated among patients who were taken off treatment. In 69.2% of patients with continued treatment with amlitelimab 250 mg Q4W with 500 mg loading dose (LD) vs 58.8% of patients withdrawn from treatment IGA 0/1 and/or EASI-75 response was maintained. An analysis including pooled dose-arms showed that IGA 0/1 response was maintained in 71.9% of patients with continued treatment vs 57% of patients withdrawn from treatment. In this analysis, EASI-75 response was maintained in 69% of patients with continued treatment vs. 61.6% of patients withdrawn from treatment. AD-related biomarkers remained reduced at Week 52 in both amlitelimab withdrawn and continuing groups, despite amlitelimab reaching negligible levels in serum. Reduction of TARC, eosinophils, and IL-22 observed at Week 24 was maintained during withdrawal as well as in patients continuing treatment to Week 52. These biomarker data suggest the modulation of inflammatory T cells via the blockade of OX40L and durable control of AD after amlitelimab withdrawal. Naimish Patel, M.D.Head of Global Development, Immunology and Inflammation, Sanofi Its unprecedented to see this type of durability of clinical response, which we believe could be very meaningful to patients and is the reason why we selected an every 12-week dosing regimen in the AD pivotal program. AD is a chronic, lifelong disease, which means we must strive to provide a portfolio of solutions to patients that matches their individual needs and puts as little burden on them as possible. We are also moving with speed in our exploration of amlitelimab's potential in 5 other chronic inflammatory diseases, including asthma, hidradenitis suppurativa, scleroderma, celiac disease, and alopecia. In addition, we are exploring 6 other innovative MOAs in 8 dermatologic indications underscoring our commitment to patients with high unmet medical needs. The aggregated safety profile of amlitelimab in Part 2 of this study was consistent with that of Part 1, with amlitelimab being well-tolerated, and no new safety concerns were identified during the 28-week maintenance/withdrawal period. Overall rates of treatment-emergent adverse events (TEAEs) were 69.8% for continued amlitelimab treatment, 71.9% for the amlitelimab withdrawal-arm and 66.7% for placebo. TEAEs more commonly observed included headache (11.6% amlitelimab continuation, 3.9% amlitelimab withdrawal, 6.7% placebo), upper respiratory tract infection (9.3% amlitelimab continuation, 5.5% amlitelimab withdrawal, 20% placebo). No adverse events such as fever or chills, oral ulcers or conjunctivitis were observed across doses. Amlitelimab is a fully human non-T cell depleting monoclonal antibody that blocks OX40-Ligand, a key immune regulator, and has the potential to be a first- or best-in-class treatment for a range of immune-mediated diseases and inflammatory disorders, including moderate-to-severe atopic dermatitis (Phase 3), asthma (Phase 2), hidradenitis suppurativa (Phase 2), scleroderma, celiac disease, and alopecia (Phase 2 studies to be initiated in 2024). By targeting OX40-Ligand, amlitelimab aims to restore balance between pro-inflammatory and regulatory T cells. Amlitelimab is currently under clinical investigation, and its safety and efficacy have not been evaluated by any regulatory authority. About STREAM-ADSTREAM-AD, a Phase 2b study, is a randomized double-blind, placebo-controlled study, evaluating amlitelimab in adult patients with moderate-to-severe atopic dermatitis whose disease was inadequately controlled with topical therapies or where such therapies were not advisable. This study is designed with two parts and is double-blind through both. Part 1 was a 24-week treatment period, and Part 2 was a 28-week maintenance/withdrawal period, which included clinical responders from Part 1, defined as participants achieving EASI-75 and/or IGA 0/1 at Week 24. Of 390 participants enrolled in Part 1, 190 entered Part 2. Participants were re-randomized 3:1 to withdraw treatment or continue pre-Week 24 subcutaneous Q4W dose (250mg with 500mg loading dose (LD), 250mg, 125mg, 62.5mg, placebo responders continuing placebo), and were followed to Week 52 for efficacy. The study enrolled 390 people in Australia, Bulgaria, Canada, Czechia, Germany, Hungary, Japan, Poland, Spain, Taiwan, the United Kingdom and the United States. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Media RelationsSandrine Guendoul|+ 33 6 25 09 14 25 |sandrine.guendoul@sanofi.comSally Bain|+ 1 617 834 6026 |sally.bain@sanofi.comVictor Rouault|+ 33 6 70 93 71 40 |victor.rouault@sanofi.com Investor RelationsEva Schaefer-Jansen|+ 33 7 86 80 56 39 |eva.schaefer-jansen@sanofi.comArnaud Delepine|+ 33 6 73 69 36 93 | arnaud.delepine@sanofi.comCorentine Driancourt|+ 33 6 40 56 92 21 | corentine.driancourt@sanofi.comFelix Lauscher|+ 1908612 7239 | felix.lauscher@sanofi.comTarik Elgoutni| + 1 617 710 3587 | tarik.elqoutni@sanofi.comNathalie Pham|+ 33 7 85 93 30 17 | natalie.pham@sanofi.com Sanofi Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words expects, anticipates, believes, intends, estimates, plans and similar expressions. Although Sanofis management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofis ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that pandemics or other global crises may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under Risk Factors and Cautionary Statement Regarding Forward-Looking Statements in Sanofis annual report on Form 20-F for the year ended December 31, 2023. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. Attachment Press Release Source: West Corporation Feb 24, 2024: Banco Santander Press Release: Phase 2 results demonstrate rilzabrutinib rapidly reduced itch severity and significantly improved disease activity in adults with chronic spontaneous urticaria Phase 2 results demonstrate rilzabrutinib rapidly reduced itch severity and significantly improved disease activity in adults with chronic spontaneous urticaria Late-breaking data at 2024 AAAAI showed rilzabrutinib, an oral BTK inhibitor, significantly reduced weekly itch severity score (ISS7) as early as the first week of treatment in adults with moderate to severe CSUData form the basis for the Phase 3 CSU and prurigo nodularis programs to start in 2024Pivotal Phase 3 readout in immune thrombocytopenia and Phase 2 readouts in asthma, IgG4-related disease and warm autoimmune hemolytic anemia expected in 2024Rilzabrutinib is one of 12 potential blockbusters in Sanofis leading immunology pipeline Paris, February 24, 2024. Positive results from the Phase 2 study RILECSU showed that rilzabrutinib significantly improved itch, hives and urticaria in adults with moderate-to-severe chronic spontaneous urticaria (CSU), whose symptoms are not adequately controlled by H1 antihistamines. These results were presented today in a late-breaking poster at the 2024 American Academy of Allergy, Asthma and Immunology (AAAAI) Annual Meeting in Washington, DC and form the basis for the Phase 3 program which is on track to start in 2024. Professor Marcus Maurer, M.D.Professor of Dermatology and Allergy, Executive Director of the Institute of Allergology at the Charite Berlin People with CSU are living with debilitating symptoms such as intensely itchy recurrent hives, swelling, or both which can have a high impact on their day-to-day lives. These data are promising news for patients that cannot be controlled with standard-of-care antihistamines the possibility of controlling itch rapidly with an oral medicine would offer an important advancement in the treatment of this disease. Naimish Patel, M.D.Head of Global Development, Immunology and Inflammation, SanofiThese data reinforce the potential of rilzabrutinib as a treatment option for patients with moderate-to-severe CSU and we believe that the rapid improvement of itch could make a meaningful difference in alleviating the physical and psychosocial burden these patients suffer from. Based on these data, later this year we will advance rilzabrutinib into Phase 3 development in both CSU and prurigo nodularis, another skin disorder characterized by relentless itching. We also look forward to data readouts for rilzabrutinib in 2024 with the opportunity to further demonstrate its potential impact across multiple immune-mediated diseases. Key ResultsIn this dose-ranging study, different doses of rilzabrutinib were evaluated: 400 mg once every evening (QPM), 400 mg twice a day (BID), 400 mg three times a day (TID). In the intent-to-treat (ITT) population which included either patients who were previously naive or incomplete responders to omalizumab, Rilzabrutinib 400 mg TID demonstrated: Significant reduction from baseline in weekly itch severity score (ISS7) at Week 12, a key symptom of the disease, [least squares mean (LSM) -9.58 vs -6.31, respectively; p=0.0181]. Significant changes in ISS7 were seen as early as Week 1. Significant reduction from baseline to week 12 in weekly urticaria activity score (UAS7) [LSM -17.95 vs -11.20, respectively; p=0.0116]. Significant reduction from baseline to week 12 in weekly hives severity score (HSS7) [LSM -8.31 vs -4.89; p<0.0100]. Rilzabrutinib was generally well-tolerated with no events of cytopenia, bleeding or atrial fibrillation seen with other BTK inhibitor. Treatment-emergent AEs occurring at a higher frequency with rilzabrutinib vs placebo were diarrhea (29.3% TID and BID, 7.9% QPM, 15% placebo), nausea (19.5% TID, 17.1% BID, 13.2% QPM, 5.0% placebo), headache (9.8% TID, 14.6% BID, 5.3% QPM, 0.0% placebo) and abdominal pain (0.0% TID, 12.2% BID, 2.6% QPM, 5.0% placebo). Rilzabrutinib is currently under clinical investigation, and its safety and efficacy have not been evaluated by any regulatory authority. About CSUCSU is an inflammatory skin condition driven mainly by the activation of cutaneous mast cells, which causes itchy recurrent hives, swelling, or both. CSU is typically treated with H1 antihistamines and biologics; however, the disease remains uncontrolled in up to 50% of patients, who are left with limited alternative treatment options. These individuals continue to experience debilitating symptoms that can significantly impact quality of life. About the RILECSU studyRILECSU is a 52-week Phase 2 study, comprising a 12-week randomized, double-blind, placebo-controlled, dose-ranging, efficacy and safety period, followed by a 40-week open-label extension period. RILECSU is evaluating rilzabrutinib in adult patients with moderate-to-severe CSU who remain symptomatic despite use of H1 antihistamine treatment and are either naive to or incomplete responders to omalizumab. The primary endpoint was change from baseline in weekly itch severity score ISS7 at 12 weeks. Secondary endpoints include change from baseline in weekly UAS7 at 12 weeks and change from baseline weekly HSS7 at 12 weeks. Participants in the trial (n=160) were randomized 1:1:1:1 to rilzabrutinib 400mg once every evening (QPM), 400mg twice a day (BID), 400mg three times a day (TID), or matching placebo. About RilzabrutinibRilzabrutinib is an oral, reversible, covalent BTK inhibitor that has the potential to be a first- or best-in-class treatment of a number of immune-mediated diseases. BTK, expressed in B cells and mast cells, plays a critical role in multiple immune-mediated disease processes. With the application of Sanofis TAILORED COVALENCY technology, rilzabrutinib can selectively inhibit the BTK target while potentially reducing the risk of off-target side effects. About Sanofi We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Media RelationsSandrine Guendoul|+ 33 6 25 09 14 25 |sandrine.guendoul@sanofi.comSally Bain|+ 1 617 834 6026 |sally.bain@sanofi.comVictor Rouault|+ 33 6 70 93 71 40 |victor.rouault@sanofi.com Investor RelationsEva Schaefer-Jansen|+ 33 7 86 80 56 39 |eva.schaefer-jansen@sanofi.comArnaud Delepine|+ 33 6 73 69 36 93 | arnaud.delepine@sanofi.comCorentine Driancourt|+ 33 6 40 56 92 21 | corentine.driancourt@sanofi.comFelix Lauscher|+ 1908612 7239 | felix.lauscher@sanofi.comTarik Elgoutni| + 1 617 710 3587 | tarik.elgoutni@sanofi.comNathalie Pham|+ 33 7 85 93 30 17 | nathalie.pham@sanofi.com Sanofi Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words expects, anticipates, believes, intends, estimates, plans and similar expressions. Although Sanofis management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofis ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that pandemics or other global crises may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under Risk Factors and Cautionary Statement Regarding Forward-Looking Statements in Sanofis annual report on Form 20-F for the year ended December 31, 2023. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. Attachment Press Release Source: West Corporation Feb 23, 2024: Banco Santander Press Release: Dupixent sBLA accepted for FDA Priority Review for treatment of COPD with type 2 inflammation Dupixent sBLA accepted for FDA Priority Review for treatment of COPD with type 2 inflammation Priority Review granted based on positive results from two Phase 3 trialsIf approved, Dupixent would be the only biologic therapy for COPD and the first new treatment approach for the disease in more than a decadeRegulatory submissions are also under review in China and Europe Paris and Tarrytown, N.Y. February 23, 2024. The U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent (dupilumab) in a sixth potential indication as an add-on maintenance treatment in certain adult patients with uncontrolled chronic obstructive pulmonary disease (COPD). The target action date for the FDA decision is June 27, 2024. Regulatory submissions are also under review in China and the European Union. The sBLA, as well as other submissions around the world, is supported by data from the Phase 3 COPD clinical research program evaluating the efficacy and safety of Dupixent in adults who were current or former smokers with uncontrolled COPD with evidence of type 2 inflammation (screening blood eosinophils >300 cells/microliter). All patients were on background maximal standard-of-care inhaled therapy (nearly all on triple therapy). The primary endpoint was met in both trials (BOREAS, NOTUS), showing Dupixent significantly reduced moderate or severe acute COPD exacerbations by 30% and 34% respectively, compared to placebo. In both trials, Dupixent also rapidly and significantly improved lung function compared to placebo, with improvements sustained at 52 weeks. Safety results in both trials were generally consistent with the known safety profile of Dupixent in its approved indications. Adverse events more commonly observed with Dupixent (5%) compared to placebo in either trial were back pain, COVID-19, diarrhea, headache and nasopharyngitis. Priority Review is granted to regulatory applications seeking approval for therapies that have the potential to provide significant improvements in the treatment, diagnosis or prevention of serious conditions. The potential use of Dupixent in COPD is currently under clinical development, and its safety and efficacy for this indication have not been fully evaluated by any regulatory authority. About COPDCOPD is a respiratory disease that damages the lungs and causes progressive lung function decline. Symptoms include persistent cough, breathlessness and excessive mucus production that may not only impair the ability to perform routine daily activities, but can also lead to anxiety, depression and sleep disturbances. COPD is also associated with a significant health and economic burden due to recurrent acute exacerbations that require systemic corticosteroid treatment and/or lead to hospitalization. Smoking and exposure to noxious particles are key risk factors for COPD, but even individuals who quit smoking can still develop or continue having the disease. There have been no new treatment approaches approved for more than a decade. In the U.S., approximately 300,000 people live with uncontrolled COPD with evidence of type 2 inflammation. About Sanofi and Regenerons COPD Clinical Research ProgramSanofiand Regeneron are motivated to transform the treatment paradigm of COPD by examining the role different types of inflammation play in the disease progression through the investigation of two potentially first-in-class biologics, Dupixent and itepekimab. Dupixent inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and the program focuses on a specific population of people with evidence of type 2 inflammation. Itepekimab is a fully human monoclonal antibody that binds to and inhibits interleukin-33 (IL-33), an initiator and amplifier of broad inflammation in COPD. Itepekimab is currently under clinical investigation, with two Phase 3 trials currently enrolling, and its safety and efficacy have not been evaluated by any regulatory authority. About DupixentDupixent is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not an immunosuppressant. The Dupixent development program has shown significant clinical benefit and a decrease in type 2 inflammation in Phase 3 trials, establishing that IL-4 and IL-13 are key and central drivers of the type 2 inflammation that plays a major role in multiple related and often co-morbid diseases. These diseases include approved indications for Dupixent, such as atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), eosinophilic esophagitis (EoE), prurigo nodularis and chronic spontaneous urticaria (CSU). Dupixent has received regulatory approvals in one or more countries around the world for use in certain patients with atopic dermatitis, asthma, CRSwNP, EoE, prurigo nodularis and CSU in different age populations. Dupixent is currently approved for one or more of these indications in more than 60 countries, including in Europe, the U.S. and Japan. More than 800,000 patients are being treated with Dupixent globally. Dupilumab Development ProgramDupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement. To date, dupilumab has been studied across more than 60 clinical trials involving more than 10,000 patients with various chronic diseases driven in part by type 2 inflammation. In addition to the currently approved indications, Sanofi and Regeneron are studying dupilumab in a broad range of diseases driven by type 2 inflammation or other allergic processes in Phase 3 trials, including chronic spontaneous urticaria, chronic pruritus of unknown origin, chronic obstructive pulmonary disease with evidence of type 2 inflammation and bullous pemphigoid. These potential uses of dupilumab are currently under clinical investigation, and the safety and efficacy in these conditions have not been fully evaluated by any regulatory authority. About Regeneron Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led for over 35 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous FDA-approved treatments and product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, hematologic conditions, infectious diseases and rare diseases. Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite technologies, such as VelocImmune, which uses unique genetically humanized mice to produce optimized fully human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world. For more information about Regeneron, please visitwww.Regeneron.comor follow Regeneron onLinkedIn. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Sanofi Media RelationsTimothy Gilbert|+ 1 516 521 2929 | timothy.gilbert@sanofi.comVictor Rouault | + 33 6 70 93 71 40 | victor.rouault@sanofi.comEvan Berland|+ 1 215 432 0234|evan.berland@sanofi.comSally Bain|+ 1 617 834 6026 |sally.bain@sanofi.com Sanofi Investor RelationsEva Schaefer-Jansen | + 33 7 86 80 56 39 | eva.schaefer-jansen@sanofi.comArnaud Delepine | + 33 06 73 69 36 93 | arnaud.delepine@sanofi.comCorentine Driancourt | + 33 06 40 56 92 | corentine.driancourt@sanofi.comFelix Lauscher | + 1 908 612 7239 | felix.lauscher@sanofi.comTarik Elgoutni | + 1 617 710 3587 | tarik.elgoutni@sanofi.comNathalie Pham | + 33 07 85 93 30 17 | nathalie.pham@sanofi.com Regeneron Media RelationsHannah Kwagh | +1 914-847-6314| hannah.kwagh@regeneron.com Regeneron Investor RelationsVesna Tosic | + 914 847 5443 | vesna.tosic@regeneron.com Sanofi Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements are generally identified by the words expects, anticipates, believes, intends, estimates, plans and similar expressions. Although Sanofis management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact that pandemics or other global crises may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under Risk Factors and Cautionary Statement Regarding Forward-Looking Statements in Sanofis annual report on Form 20-F for the year ended December 31, 2022. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. Regeneron Forward-Looking Statements and Use of Digital Media This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. (Regeneron or the Company), and actual events or results may differ materially from these forward-looking statements. Words such as anticipate, expect, intend, plan, believe, seek, estimate, variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, Regenerons Products) and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, Regenerons Product Candidates) and research and clinical programs now underway or planned, including without limitation Dupixent (dupilumab) and itepekimab for the treatment of chronic obstructive pulmonary disease (COPD); the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regenerons Product Candidates and new indications for Regenerons Products, such as Dupixent and itepekimab for the treatment of COPD (including, in the case of Dupixent, based on the supplemental Biologics License Application discussed in this press release) as well as Dupixent for the treatment of chronic spontaneous urticaria, chronic pruritus of unknown origin, chronic obstructive pulmonary disease with evidence of type 2 inflammation, bullous pemphigoid, and other potential indications; uncertainty of the utilization, market acceptance, and commercial success of Regenerons Products and Regenerons Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary), including the studies discussed or referenced in this press release, on any of the foregoing or any potential regulatory approval of Regenerons Products (such as Dupixent) and Regenerons Product Candidates (such as itepekimab); the ability of Regenerons collaborators, licensees, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regenerons Products and Regenerons Product Candidates; the ability of Regeneron to manage supply chains for multiple products and product candidates; safety issues resulting from the administration of Regenerons Products (such as Dupixent) and Regenerons Product Candidates (such as itepekimab) in patients, including serious complications or side effects in connection with the use of Regenerons Products and Regenerons Product Candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict Regenerons ability to continue to develop or commercialize Regenerons Products and Regenerons Product Candidates; ongoing regulatory obligations and oversight impacting Regenerons Products, research and clinical programs, and business, including those relating to patient privacy; the availability and extent of reimbursement of Regenerons Products from third-party payers, including private payer healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payers and new policies and procedures adopted by such payers; competing drugs and product candidates that may be superior to, or more cost effective than, Regenerons Products and Regenerons Product Candidates; the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators or licensees may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license, collaboration, or supply agreement, including Regenerons agreements with Sanofi and Bayer (or their respective affiliated companies, as applicable) to be cancelled or terminated; the impact of public health outbreaks, epidemics, or pandemics (such as the COVID-19 pandemic) on Regeneron's business; and risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA (aflibercept) Injection), other litigation and other proceedings and government investigations relating to the Company and/or its operations, the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regenerons business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regenerons filings with the U.S. Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2023. Any forward-looking statements are made based on managements current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise. Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regeneron's media and investor relations website (https://investor.regeneron.com) and its LinkedIn page (https://www.linkedin.com/company/regeneron-pharmaceuticals) Attachment Press Release Source: West Corporation Feb 23, 2024: Banco Santander Press Release: Filing of the 2023 U.S. Form 20-F and French Document dEnregistrement Universel containing the Annual Financial Report Filing of the 2023 U.S. Form 20-F and French Document dEnregistrement Universel containing the Annual Financial Report Paris, February 23, 2024. Sanofi announces today the filing of its Form 20-F with the U.S. Securities and Exchange Commission (SEC) and its Document dEnregistrement Universel containing its Annual Financial Report with the French market regulator Autorite des marches financiers (AMF). These documents are available on the companys website: https://www.sanofi.com/en/investors/reports-and-publications/financial-reports-and-regulated-information In addition, the Form 20-F is available on the website of the SEC (www.sec.gov) and the Document dEnregistrement Universel is available on the website of the AMF (www.amf-france.org). A hard copy of these documents, each of which contains our complete audited financial statements, may be received free of charge, upon request. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Media RelationsSandrine Guendoul|+ 33 6 25 09 14 25 |sandrine.guendoul@sanofi.comNicolas Obrist|+ 33 6 77 21 27 55 |nicolas.obrist@sanofi.comVictor Rouault|+ 33 6 70 93 71 40 |victor.rouault@sanofi.com Investor RelationsEva Schaefer-Jansen|+ 33 7 86 80 56 39 |eva.schaefer-jansen@sanofi.comArnaud Delepine|+ 33 6 73 69 36 93 | arnaud.delepine@sanofi.comCorentine Driancourt|+ 33 6 40 56 92 21 | corentine.driancourt@sanofi.comFelix Lauscher|+ 1 908 612 7239 | felix.lauscher@sanofi.comTarik Elgoutni | + 1 617 710 3587 | tarik.elgoutni@sanofi.comNathalie Pham|+ 33 7 85 93 30 17 | nathalie.pham@sanofi.com Attachment Press_Release Source: West Corporation Feb 16, 2024: Banco Santander Press Release: Japan first in the world to approve Dupixent for chronic spontaneous urticaria (CSU) Japan first in the world to approve Dupixent for chronic spontaneous urticaria (CSU) Approval based primarily on results from Phase 3 trial showing Dupixent significantly reduced itch compared to placeboCSU is the fifth approved indication for Dupixent in Japan and the sixth indication for Dupixent globally Paris and Tarrytown, N.Y. February 16, 2024. The Ministry of Health, Labor and Welfare (MHLW) in Japan has granted marketing and manufacturing authorization for Dupixent (dupilumab) for the treatment of chronic spontaneous urticaria (CSU) in people aged 12 years and older whose disease is not adequately controlled with existing therapy. Japan is the first country to approve Dupixent for CSU, emphasizing the value of Dupixent as a novel treatment option to manage this disease in patients with unmet needs. CSU is a chronic inflammatory skin disease driven in part by type 2 inflammation, which causes sudden and debilitating hives and persistent itch. CSU is typically treated with histamine (H1) antihistamines, medicines that target H1 receptors on cells to control symptoms of urticaria. However, the disease remains uncontrolled despite antihistamine treatment in many patients, some of whom are left with limited alternative treatment options. These individuals continue to experience symptoms that can be debilitating and significantly impact their quality of life. Approximately 110,000 people aged 12 years and older suffer from uncontrolled moderate-to-severe CSU in Japan, for which there are currently limited treatments. The Japanese approval is based primarily on data from Study A of the LIBERTY-CUPID clinical trial program evaluating Dupixent as an add-on therapy to standard-of-care H1 antihistamines compared to antihistamines alone (placebo) in 138 patients with CSU who remained symptomatic despite antihistamine use and were not previously treated with omalizumab. This study met the primary and all key secondary endpoints. Patients taking Dupixent added to standard-of-care antihistamines experienced a significant reduction in itch severity compared to standard of care alone at 24 weeks. The safety profile of Dupixent in CSU was generally consistent with the known safety of Dupixent in its approved dermatological indications. In addition to CSU, Dupixent is approved in Japan in certain patients with atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), and prurigo nodularis. About Dupixent Dupixent is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not an immunosuppressant. The Dupixent development program has shown significant clinical benefit and a decrease in type 2 inflammation in Phase 3 trials, establishing that IL-4 and IL-13 are key and central drivers of the type 2 inflammation that plays a major role in multiple related and often co-morbid diseases. These diseases include approved indications for Dupixent, such as atopic dermatitis, asthma, CRSwNP, prurigo nodularis and eosinophilic esophagitis (EoE). Dupixent has received regulatory approvals in one or more countries around the world for use in certain patients with atopic dermatitis, asthma, CRSwNP, EoE, prurigo nodularis, and CSU in different age populations. Dupixent is currently approved for one or more of these indications in more than 60 countries, including in Japan, Europe and the U.S. More than 800,000 patients are being treated with Dupixent globally. The potential use of Dupixent in CSU is under clinical development in additional countries around the world, and its safety and efficacy have not been fully evaluated by any regulatory authority outside of Japan. Dupilumab development program Dupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement. To date, dupilumab has been studied across more than 60 clinical trials involving more than 10,000 patients with various chronic diseases driven in part by type 2 inflammation. In addition to the currently approved indications, Sanofi and Regeneron are studying dupilumab in a broad range of diseases driven by type 2 inflammation or other allergic processes in Phase 3 trials, including chronic pruritus of unknown origin, chronic obstructive pulmonary disease (COPD) with evidence of type 2 inflammation, and bullous pemphigoid. These potential uses of dupilumab are currently under clinical investigation, and the safety and efficacy in these conditions have not been fully evaluated by any regulatory authority. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people's lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions.Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY. About RegeneronRegeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led for over 35 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous FDA-approved treatments and product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, hematologic conditions, infectious diseases and rare diseases. Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite technologies, such as VelocImmune, which uses unique genetically humanized mice to produce optimized fully human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world. For more information about Regeneron, please visit www.Regeneron.com or follow Regeneron on LinkedIn. Sanofi Media RelationsSally Bain|+ 1 617 834 6026 |sally.bain@sanofi.comEvan Berland | +1 215 432 0234 | evan.berland@sanofi.comVictor Rouault | + 33 6 70 93 71 40 | victor.rouault@sanofi.com Sanofi Investor RelationsEva Schaefer-Jansen | + 33 7 86 80 56 39 | eva.schaefer-jansen@sanofi.comArnaud Delepine | + 33 06 73 69 36 93 | arnaud.delepine@sanofi.comCorentine Driancourt | + 33 06 40 56 92 | corentine.driancourt@sanofi.comFelix Lauscher | + 1 908 612 7239 | felix.lauscher@sanofi.comTarik Elgoutni | + 1 617 710 3587 | tarik.elgoutni@sanofi.comNathalie Pham | + 33 07 85 93 30 17 | nathalie.pham@sanofi.com Regeneron Media RelationsIlana Yellen | +1 914-330-9618| ilana.yellen@regeneron.com Regeneron Investor RelationsVesna Tosic | + 914 847 5443 | vesna.tosic@regeneron.com Sanofi Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements are generally identified by the words expects, anticipates, believes, intends, estimates, plans and similar expressions. Although Sanofis management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact that pandemics or other global crises may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under Risk Factors and Cautionary Statement Regarding Forward-Looking Statements in Sanofis annual report on Form 20-F for the year ended December 31, 2022. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. Regeneron Forward-Looking Statements and Use of Digital Media This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. (Regeneron or the Company), and actual events or results may differ materially from these forward-looking statements. Words such as anticipate, expect, intend, plan, believe, seek, estimate, variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, Regenerons Products) and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, Regenerons Product Candidates) and research and clinical programs now underway or planned, including without limitation Dupixent (dupilumab) for the treatment of chronic spontaneous urticaria (CSU); uncertainty of the utilization, market acceptance, and commercial success of Regenerons Products and Regenerons Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary), such as the studies discussed or referenced in this press release, on any of the foregoing (including whether the results of any such studies will be deemed sufficient for regulatory approval of Dupixent for the treatment of CSU by regulatory agencies of other countries); the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regenerons Product Candidates and new indications for Regenerons Products, such as Dupixent for the treatment of chronic pruritus of unknown origin, chronic obstructive pulmonary disease with evidence of type 2 inflammation, bullous pemphigoid, and other potential indications, as well as potential regulatory approval of Dupixent for the treatment in CSU by regulatory agencies of other countries; the ability of Regenerons collaborators, licensees, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regenerons Products and Regenerons Product Candidates; the ability of Regeneron to manage supply chains for multiple products and product candidates; safety issues resulting from the administration of Regenerons Products (such as Dupixent) and Regenerons Product Candidates in patients, including serious complications or side effects in connection with the use of Regenerons Products and Regenerons Product Candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict Regenerons ability to continue to develop or commercialize Regenerons Products and Regenerons Product Candidates (such as potential regulatory approval of Dupixent for the treatment in CSU in other countries); ongoing regulatory obligations and oversight impacting Regenerons Products, research and clinical programs, and business, including those relating to patient privacy; the availability and extent of reimbursement of Regenerons Products from third-party payers, including private payer healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payers and new policies and procedures adopted by such payers; competing drugs and product candidates that may be superior to, or more cost effective than, Regenerons Products and Regenerons Product Candidates; the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators or licensees may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license, collaboration, or supply agreement, including Regenerons agreements with Sanofi and Bayer (or their respective affiliated companies, as applicable) to be cancelled or terminated; the impact of public health outbreaks, epidemics, or pandemics (such as the COVID-19 pandemic) on Regeneron's business; and risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA (aflibercept) Injection), other litigation and other proceedings and government investigations relating to the Company and/or its operations, the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regenerons business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regenerons filings with the U.S. Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2023. Any forward-looking statements are made based on managements current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise. Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regeneron's media and investor relations website (https://investor.regeneron.com) and its LinkedIn page (https://www.linkedin.com/company/regeneron-pharmaceuticals). Attachment Press Release Source: West Corporation Feb 15, 2024: Banco Santander Press Release: Phase 2 data published in NEJM show potential of frexalimab as high-efficacy therapy in relapsing MS Phase 2 data published in NEJM show potential of frexalimab as high-efficacy therapy in relapsing MS High-dose frexalimab significantly reduced disease activity, demonstrating 89% reduction in new brain lesions Phase 3 trials in relapsing MS and non-relapsing secondary progressive MS currently underway Paris, February 15, 2024. The New England Journal of Medicine published results from a positive Phase 2 clinical trial demonstrating frexalimab significantly slowed disease activity in people with relapsing multiple sclerosis (MS), corresponding to 89% and 79% reduction in new gadolinium-enhancing (GdE) T1 brain lesions at Week 12 in the high- and low-dose treatment arms compared to placebo, meeting the studys primary endpoint. Findings also showed both doses of frexalimab provided significant reduction in new or enlarging T2 lesions, a secondary endpoint of the study. Frexalimab is Sanofis novel second-generation investigational anti-CD40L antibody that has a unique method of action with the potential to address both acute and chronic neuroinflammation in MS without causing lymphocyte depletion. These data were previously presented at Consortium of Multiple Sclerosis Centers annual meeting 2023. Patrick Vermersch, MD, PhD University of Lille, CHU Lille, FranceThese published Phase 2 results for frexalimab represent important data in not only the potential treatment of MS but to the broader MS community. Of note, at Week 12, both doses of frexalimab provided reduction of new lesions a standard measure of active inflammation in MS and was well-sustained over time and well tolerated, especially at the high dose of frexalimab where 96% of patients were free of new active lesions after 24 weeks of treatment. Results published in NEJM stem from the Phase 2 clinical trial that randomized 129 adults with relapsing MS to receive one of two doses of the anti-CD40L antibody frexalimab (n=52 and n=51, in the high- and low-dose treatment arms, respectively) or matching placebo (n=12 and n=14, respectively; pooled for efficacy analyses). In the high-dose treatment arm, participants received 1200 mg of frexalimab intravenously every 4 weeks with an 1800 mg loading dose. In the low-dose treatment arm, participants received 300 mg of frexalimab subcutaneously every 2 weeks with a 600 mg loading dose. After 12 weeks of treatment, both doses of frexalimab led to significant reductions in: The number of new GdE T1-lesions at Week 12, providing rate ratios of 0.11 (95% CI, 0.03 to 0.38) and 0.21 (95% CI, 0.08 to 0.56), corresponding to 89% and 79% reduction in the high- and low-dose treatment arms versus placebo, the primary endpoint.The number of new/enlarging T2-lesions at Week 12, providing rate ratios of 0.08 (95% CI, 0.03 to 0.26) and 0.14 (95% CI, 0.05 to 0.41), corresponding to 92% and 86% reduction in the high- and low-dose treatment arms versus placebo, respectively, a secondary endpoint.The total number of GdE T1-lesions at Week 12 providing rate ratios of 0.12 (95% CI, 0.04 to 0.36) and 0.20 (95% CI, 0.07 to 0.53) corresponding to 88% and 80% reduction, respectively, another secondary endpoint. The effects on the primary endpoint were sustained over time across both treatment arms, with even greater reduction seen in the high-dose frexalimab treatment arm, as 96% of these study participants were free of new GdE T1-lesions at Week 24. Exploratory endpoints looked at changes in the Multiple Sclerosis Impact Scale 29 (MSIS-29), a patient-reported outcome, plasma neurofilament light chain (NfL), which has been identified as a biomarker of neuroaxonal damage and MS disease activity, as well as plasma levels of CXCL13, a biomarker of inflammatory activity. Over 12 weeks of treatment, patient-reported outcome MSIS-29 physical impact scores improved significantly in participants receiving the higher dose of frexalimab. The least-square [LS] mean difference (95% confidence interval) was -7.9 (-14.7,-1.2), compared to pooled placebo. Both doses of frexalimab achieved a reduction in NfL levels relative to baseline (24% and 18% in the high- and low-dose treatment arms, respectively) and in CXCL13 levels relative to baseline (21% and 30% in the high- and low-dose treatment arms, respectively) compared to pooled placebo at Week 12. Frexalimab was well-tolerated, and 125 (97%) participants completed Part A and continued to the open-label Part B. The most common adverse events (5%) in any frexalimab-treated group were COVID-19 (n=5 [9.8%] in the lower-dose group; all uncomplicated cases of mild or moderate intensity) and headache (n=1 [2.0%] and n=3 [5.8%] in the low- and high-dose group, respectively). Sanofi has initiated Phase 3 clinical trials of frexalimab in relapsing MS and non-relapsing secondary progressive MS. About the Phase 2 trial The Phase 2 trial was a randomized, double-blind, placebo-controlled trial evaluating frexalimab in participants with relapsing MS. Participants were randomized (4:4:1:1) to receive either high or low doses of frexalimab or matching placebo for 12 weeks (Part A). The primary endpoint was the reduction in the number of new GdE T1 MRI brain lesions at Week 12. Secondary endpoints included additional MRI-based efficacy measures as well as the safety, tolerability and pharmacokinetics of frexalimab. After Week 12, participants receiving placebo switched to respective frexalimab arms and entered the open-label Part B, which is currently ongoing. About frexalimab Frexalimab (SAR441344) is a potentially best-in-disease second generation investigational anti-CD40L antibody that blocks the costimulatory CD40/CD40L pathway which is important for activation and function of adaptive (T and B cells) and innate (macrophages/microglia and dendritic cells) immunity. Through this unique upstream mechanism of action, frexalimab has the potential to address both acute and chronic neuroinflammation in MS, without causing lymphocyte depletion. Sanofi is developing frexalimab under an exclusive license from ImmuNext Inc. Frexalimab is being evaluated in Phase 3 clinical trials for Multiple Sclerosis and Phase 2 clinical trials for Sjogrens Syndrome, Systemic Lupus Erythematosus, and Type 1 Diabetes, and its safety and efficacy have not been reviewed by any regulatory authority. For more information on frexalimab clinical trials, please visit www.clinicaltrials.gov. About Sanofi We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions.Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Media RelationsSandrine Guendoul|+ 33 6 25 09 14 25 |sandrine.guendoul@sanofi.com victor.rouault@sanofi.comSally Bain|+ 1 617 834 6026 |sally.bain@sanofi.comVictor Rouault|+ 33 6 70 93 71 40 |victor.rouault@sanofi.comTimothy Gilbert|+ 1 516 521 2929 | timothy.gilbert@sanofi.com Investor RelationsEva Schaefer-Jansen|+ 33 7 86 80 56 39 |eva.schaefer-jansen@sanofi.comArnaud Delepine|+ 33 6 73 69 36 93 | arnaud.delepine@sanofi.comCorentine Driancourt|+ 33 6 40 56 92 21 | corentine.driancourt@sanofi.comFelix Lauscher|+ 1908612 7239 | felix.lauscher@sanofi.comTarik Elgoutni|+ 1 617 710 3587 |tarik.elgoutni@sanofi.comNathalie Pham|+ 33 7 85 93 30 17 | nathalie.pham@sanofi.com Sanofi Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words expects, anticipates, believes, intends, estimates, plans and similar expressions. Although Sanofis management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofis ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that pandemics or other global crises may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under Risk Factors and Cautionary Statement Regarding Forward-Looking Statements in Sanofis annual report on Form 20-F for the year ended December 31, 2022. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. Attachment Press_Release Source: West Corporation 2023 Aug 03, 2023: Banco Santander Press Release: U.S. CDC Advisory Committee unanimously recommends routine use of Beyfortus (nirsevimab-alip) to protect infants against RSV disease U.S. CDC Advisory Committee unanimously recommends routine use of Beyfortus (nirsevimab-alip) to protect infants against RSV disease Recommendation for use in all infants below 8 months of age follows earlier than anticipated FDA approval and unanimous FDA Advisory Committee voteCommittee also voted unanimously to include Beyfortus in the Vaccines for Children program, supporting equitable access for all eligible infantsBeyfortus is the first RSV prevention approved to protect all infants in the U.S. through their first RSV season and will be available ahead of the 2023-2024 RSV season Paris, August 3, 2023. The U.S. Centers for Disease Control and Preventions (CDC) Advisory Committee on Immunization Practices (ACIP) voted unanimously 10 to 0 to recommend routine use of Sanofi and AstraZenecas Beyfortus (nirsevimab-alip) for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease for newborns and infants below 8 months of age born during or entering their first RSV season. The Committee also voted unanimously 10 to 0 to recommend routine use of Beyfortus for children aged 8 to 19 months who are at increased risk of severe RSV disease and entering their second RSV season. Additionally, the ACIP voted unanimously 11 to 0 to include Beyfortus in the Vaccines for Children (VFC) program. Beyfortuswill be available in the U.S. ahead of the upcoming 2023-2024 RSV season. Thomas Triomphe Executive Vice President, Vaccines, Sanofi Today, we have turned the corner on the threat of RSV to our youngest, most vulnerable population. The ACIPs unanimous recommendations for routine use of Beyfortus and inclusion in the Vaccines for Children program are critical steps toward providing millions of parents in the U.S. with the ability to protect their babies through their first RSV season, when they are most susceptible to severe RSV disease. We appreciate the FDA and CDC leadership, as well as the ACIP public health experts, for recognizing and quickly acting on the threat RSV poses to all infants. Dr Regena Spratling, PhD, RN, APRN, CPNP-PC, FAANP, FAAN President, National Association of Pediatric Nurse PractitionersAs front-line providers managing the physical and emotional toll of RSV on our patients and their families, especially during the surges of the last two years, our community of pediatric-focused nurse practitioners welcomes the recent approval of nirsevimab. Todays ACIP vote to include nirsevimab in routine immunization schedules, along with continued efforts to educate the public about the impact of RSV prevention, will help ensure equitable access to this immunization and help alleviate the strain RSV disease places on babies, families, and health care systems. The provisional ACIP recommendations will be forwarded to the director of the CDC and the U.S. Department of Health and Human Services for review and approval. The official recommendations will be published in the CDCs Morbidity and Mortality Weekly Report (MMWR). Once approved, routine use of Beyfortus would be included in the CDCs Child and Adolescent Immunization Schedule. About the U.S. ACIP and CDC recommendationsThe ACIP is a body of independent health experts that advises the CDC and the nation on the types of populations and circumstances for which immunizations should be used. The CDC reviews advice from the ACIP and publishes final recommendations in the MMWR. The Affordable Care Act (ACA) generally requires coverage for all immunizations administered in accordance with final CDC recommendations. This requirement applies to all non-grandfathered commercial plans and Medicaid expansion beneficiaries. Individuals, or their healthcare providers, should contact their health insurance plan to determine coverage and reimbursement requirements as well as adoption timeframes. The Vaccines for Children (VFC) program helps provide immunizations to children whose parents or guardians may not be able to afford them. This helps ensure that all children have a better chance of getting their recommended immunizations on schedule. About RSVRSV is a very contagious virus that can lead to serious respiratory illness for infants, according to the Centers for Disease Control and Prevention (CDC). RSV symptoms can include runny nose, coughing, sneezing, fever, decrease in appetite, and wheezing.1 Two out of three infants are infected with RSV during their first year of life and almost all children are infected by their second birthday.1,2 In the U.S., RSV is the leading cause of hospitalization in infants under 12 months, averaging 16 times higher than the annual rate for influenza.3,4 Approximately 75% of infants hospitalized for RSV are born healthy and at term with no underlying conditions.5 Each year in the U.S., an estimated 590,000 RSV disease cases in infants under one require medical care, including physician office, urgent care, emergency room visits and hospitalizations.6 About BeyfortusIn the U.S., Beyfortus is the first RSV prevention approved to protect all infants through their first RSV season, including for those born healthy at term or preterm, or with specific health conditions that make them vulnerable to RSV disease. Beyfortus is also approved for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season. As a long-acting antibody provided directly to newborns and infants as a single dose, Beyfortus offers rapid protection to help prevent lower respiratory tract disease caused by RSV without requiring activation of the immune system.7 Beyfortus administration can be timed to the start of the RSV season. Beyfortus was granted Breakthrough Therapy and Fast-Track designations and was approved by the FDA on July 17, 2023 following the positive recommendation of the FDA Antimicrobial Drugs Advisory Committee. The approval was based on the extensive Beyfortus clinical development program spanning three pivotal late-stage clinical trials. Across all clinical endpoints, a single dose of Beyfortus delivered high, consistent and sustained efficacy against RSV lower respiratory tract disease extending through five months, a typical RSV season. In March 2017, Sanofi and AstraZeneca announced an agreement to develop and commercialize Beyfortus. Under the terms of the agreement, AstraZeneca leads development and manufacturing activities and Sanofi leads commercialization activities and records revenues. Under the terms of the global agreement, Sanofi made an upfront payment of 120m, has paid development and regulatory milestones of 120m and will pay up to a further 375m upon achievement of certain regulatory and sales-related milestones. The two companies share costs and profits in all territories except in the U.S. where Sanofi consolidates 100% of the economic benefits in its Business Operating Income. Beyfortus has been granted special designations to facilitate expedited development by several regulatory agencies around the world. These include Breakthrough Therapy Designation and Priority Review designation by The China Center for Drug Evaluation under the National Medical Products Administration;Breakthrough TherapyDesignationand Fast Track Designation from the U.S. Food and Drug Administration; access granted to the European Medicines Agency (EMA)PRIorityMEdicines(PRIME) scheme and EMA accelerated assessment; Promising Innovative Medicine designation by the UK Medicines and Healthcare products Regulatory Agency; and has been named a medicine for prioritized development under the Project for Drug Selection to Promote New Drug Development in Pediatrics by the Japan Agency for Medical Research and Development. Beyfortus has been granted marketing authorization in the European Union, Great Britain and Canada for the prevention of RSV lower respiratory tract disease in newborns and infants from birth through their first RSV season and is currently undergoing regulatory review in China, Japan and several other countries. In Canada, nirsevimab is also approved for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season and such indication is under review at the EMA level. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Media RelationsSandrine Guendoul|+ 33 6 25 09 14 25 |sandrine.guendoul@sanofi.comEvan Berland | +1 215 432 0234 | evan.berland@sanofi.comNicolas Obrist|+ 33 6 77 21 27 55 |nicolas.obrist@sanofi.com Investor RelationsEva Schaefer-Jansen|+ 33 7 86 80 56 39 |eva.schaefer-jansen@sanofi.comArnaud Delepine|+ 33 6 73 69 36 93 | arnaud.delepine@sanofi.comCorentine Driancourt|+ 33 6 40 56 92 21 | corentine.driancourt@sanofi.comFelix Lauscher|+ 1908612 7239 | felix.lauscher@sanofi.comTarik Elgoutni| + 1 617 710 3587 | tarik.elgoutni@sanofi.comNathalie Pham|+ 33 7 85 93 30 17 | nathalie.pham@sanofi.com Sanofi Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words expects, anticipates, believes, intends, estimates, plans and similar expressions. Although Sanofis management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofis ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that pandemics or other global crises may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under Risk Factors and Cautionary Statement Regarding Forward-Looking Statements in Sanofis annual report on Form 20-F for the year ended December 31, 2022. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. References Attachment Press_Release Source: West Corporation Jul 28, 2023: Banco Santander Press release: Online availability of Sanofis half-year financial report for 2023 Online availability of Sanofis half-year financial report for 2023 Paris, July 28, 2023. Sanofi announces that its half-year financial report for the period ending June 30, 2023 is now available and has been filed with the French market regulator Autorite des marches financiers (AMF) and submitted to the U.S. Securities and Exchange Commission (SEC) under form 6-K. This document may be found on the companys corporate website: www.sanofi.com and downloaded from the Investors page, under the heading Regulated Information in France. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Media RelationsSandrine Guendoul|+ 33 6 25 09 14 25 |sandrine.guendoul@sanofi.comNicolas Obrist|+ 33 6 77 21 27 55 |nicolas.obrist@sanofi.comVictor Rouault|+ 33 6 70 93 71 40 |victor.rouault@sanofi.com Investor RelationsEva Schaefer-Jansen|+ 33 7 86 80 56 39 |eva.schaefer-jansen@sanofi.comArnaud Delepine|+ 33 6 73 69 36 93 | arnaud.delepine@sanofi.comCorentine Driancourt|+ 33 6 40 56 92 21 | corentine.driancourt@sanofi.comFelix Lauscher|+ 1908612 7239 | felix.lauscher@sanofi.comTarik Elgoutni| + 1 617 710 3587 | tarik.elgoutni@sanofi.comNathalie Pham|+ 33 7 85 93 30 17 | nathalie.pham@sanofi.com Attachment Press Release Source: West Corporation Jul 28, 2023: Banco Santander Press Release: Solid Q2 performance and strong pipeline momentum, Full-year 2023 business EPS guidance raised Solid Q2 performance and strong pipeline momentum, Full-year 2023 business EPS guidance raised Paris, July 28, 2023 Q2 2023 sales growth of 3.3% at CER and business EPS(1) growth of 8.1% at CER Specialty Care grew 11.8% driven by Dupixent (2,562 million, +34.2%) and Nexviazyme (103 million, +146.5%) more than offsetting anticipated impact of Aubagio generic competition in the U.S.Vaccines up 9.1% due to strong PPH vaccines sales in Rest of World region and COVID vaccine supply in EuropeGeneral Medicines core assets grew 2.4%, non-core assets lower mainly due to Lantus (353 million, -36.5%) CHC sales growth continued (+0.7%) despite unfavorable effect from inventory build in the prior quarterBusiness EPS(1) of 1.74 up 0.6% on a reported basis and 8.1% at CER IFRS EPS of 1.15 (up 22.3%) Key R&D milestones and regulatory achievements in Q2 Nirsevimab unanimous FDA AdCom vote for prevention of RSV lower respiratory tract disease in infantsDupixent BOREAS Phase 3 COPD results presented at ATS and published in the New England Journal of MedicineItepekimab in COPD passed a recent interim futility analysis of the Phase 3 AERIFY studiesAmlitelimab positive Phase 2b data support potential for transformational target profile in Atopic DermatitisFrexalimab Phase 2b primary endpoint met demonstrating significantly reduced disease activity in MSVaccines pipeline moving at pace with 12 innovative assets with new data highlighted at a recent investor event Progress on Corporate Social Responsibility strategy in Q2 Inclusivity targets implemented across clinical trial; 45% of U.S. trials achieved at least 1 targetB Corp Certification granted to CHC North America in recognition of environmental and social achievements Full-year 2023 business EPS guidance revised upward Paul Hudson, Sanofi Chief Executive Officer, commented: We have delivered yet another quarter of growth, with Specialty Care and Vaccines as the main drivers. As we move into the second half our Play to Win strategy, we are particularly enthusiastic about the strong flow of positive R&D data readouts and regulatory achievements of this second quarter, highlighting the significant growth potential of our innovative pipeline assets. With the FDA approval of Beyfortus for the prevention of RSV in all infants in July, the landmark Phase 3 data in COPD with Dupixent, and the important clinical milestones with amlitelimab and frexalimab which support our decision to initiate pivotal trials, we expect to add multiple innovative medicines to our existing growth drivers over the coming years. As we enter the second half of 2023, we are executing on our new launches and we are encouraged by the early launch indicators of ALTUVIIIOTM and TZIELDTM, while navigating the anticipated impact from generic competition on Aubagio. Our strong results in the first six months make us confident in our outlook for the remainder of the year and as a consequence we are raising our full-year 2023 EPS guidance to mid single-digit growth. Source: West Corporation Jul 17, 2023: Banco Santander Press Release: FDA approves Beyfortus (nirsevimab-alip) to protect infants against RSV disease FDA approves Beyfortus (nirsevimab-alip) to protect infants against RSV disease Beyfortus is the first monoclonal antibody approved to protect all infants through their first RSV seasonAcross all clinical endpoints, a single dose of Beyfortus delivered high, consistent and sustained efficacy and favorable safety against RSV diseaseApproval also includes use for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season Paris, July 17, 2023. The U.S. Food and Drug Administration (FDA) has approved Sanofi and AstraZenecas Beyfortus (nirsevimab-alip) for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) in newborns and infants born during or entering their first RSV season, and for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season. The companies plan to make Beyfortus available in the U.S. ahead of the upcoming 2023-2024 RSV season. RSV is the leading cause of hospitalization for infants under the age of one in the U.S., averaging 16 times higher than the annual rate for influenza.1,2 Each year, an estimated 590,000 RSV disease cases in infants under one require medical care, including physician office, urgent care, emergency room visits and hospitalizations.3 Thomas TriompheExecutive Vice President, Vaccines, SanofiTodays approval marks an unprecedented moment for protecting infant health in the U.S., following an RSV season that took a record toll on infants, their families, and the U.S. healthcare system. Beyfortus is the only monoclonal antibody approved for passive immunization to provide safe and effective protection for all infants during their first RSV season. I am proud that, by prioritizing this potential game-changer, we are now about to bring Beyfortus to American families. Iskra ReicExecutive Vice President, Vaccines and Immune Therapies, AstraZenecaBeyfortus represents an opportunity for a paradigm-shift in preventing serious respiratory disease due to RSV across a broad infant population in the U.S. The science that Beyfortus is built on demonstrates AstraZenecas continued leadership in addressing the needs of the most vulnerable populations and reducing the burden on healthcare systems. The FDA decision follows the positive recommendation of the FDA Antimicrobial Drugs Advisory Committee and was based on the extensive Beyfortus clinical development program spanning three pivotal late-stage clinical trials. Across all clinical endpoints, a single dose of Beyfortus demonstrated high and consistent efficacy against RSV LRTD extending through five months, a typical RSV season. Beyfortus was well tolerated with a favorable safety profile that was consistent across all clinical trials. The overall rates of adverse events were comparable between Beyfortus and placebo and the majority of adverse events were mild or moderate in severity. The most common adverse events were rash and injection site reactions. The single administration of Beyfortus was developed to correspond with the beginning of the RSV season for babies born prior to the season or at birth for those born during the RSV season. In clinical trials, Beyfortus helped prevent RSV LRTD requiring medical care in all infant populations studied, including those born healthy at term, late preterm or preterm, or with specific health conditions that make them vulnerable to severe RSV disease. RSV diseaserequiring medical care included physician office, urgent care, emergency room visits and hospitalizations. Beyfortus, jointly developed by Sanofi and AstraZeneca, was approved in the European Union in October 2022, in Great Britain in November 2022, and recently received approval in Canada in April 2023. Regulatory applications are also currently under review in China, Japan and several other countries. About RSVRSV is a very contagious virus that can lead to serious respiratory illness for infants, according to the Centers for Disease Control and Prevention (CDC). RSV symptoms can include runny nose, coughing, sneezing, fever, decrease in appetite, and wheezing.4 Two out of three infants are infected with RSV during their first year of life and almost all children are infected by their second birthday.4,5 In the U.S., RSV is the leading cause of hospitalization in infants under 12 months, averaging 16 times higher than the annual rate for influenza.1,2 Approximately 75% of infants hospitalized for RSV are born healthy and at term with no underlying conditions.6 Each year in the U.S., an estimated 590,000 RSV disease cases in infants under one require medical care, including physician office, urgent care, emergency room visits and hospitalizations.3 About BeyfortusIn the U.S., Beyfortus is a single-dose long-acting antibody designed to help prevent RSV lower respiratory tract disease in all infants through their first RSV season. Beyfortus is also indicated for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season. Beyfortus, provided directly to newborns and infants as a single dose, offers rapid protection via an antibody to help prevent LRTD caused by RSV, without requiring activation of the immune system.7 Beyfortus administration can be timed to the start of the RSV season. In March 2017, Sanofi and AstraZeneca announced an agreement to develop and commercialize Beyfortus. Under the terms of the agreement, AstraZeneca leads development and manufacturing activities and Sanofi leads commercialization activities and records revenues. Under the terms of the global agreement, Sanofi made an upfront payment of120m, has paid development and regulatory milestones of 55m and will pay up to a further440m upon achievement of certain regulatory and sales-related milestones. The two companies share costs and profits in all territories except in the U.S. where Sanofi consolidates 100% of the economic benefits in its Business Operating Income. Beyfortus has been granted special designations to facilitate expedited development by several regulatory agencies around the world. These include Breakthrough Therapy Designation and Priority Review designation by The China Center for Drug Evaluation under the National Medical Products Administration; Breakthrough Therapy Designation from the U.S. Food and Drug Administration; access granted to the European Medicines Agency(EMA) PRIority MEdicines (PRIME) scheme and EMA accelerated assessment; Promising Innovative Medicine designation by the UK Medicines and Healthcare products Regulatory Agency; and has been named a medicine for prioritized development under the Project for Drug Selection to Promote New Drug Development in Pediatrics by the Japan Agency for Medical Research and Development. Beyfortus has been granted marketing authorization in the European Union, Great Britain and Canada for the prevention of RSV lower respiratory tract disease in newborns and infants from birth through their first RSV season and is currently undergoing regulatory review in China, Japan and several other countries. In Canada, nirsevimab is also approved for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season and such indication is under review at the EMA level. About the clinical trials The Phase 2b trial (Trial 03) was a randomized, placebo-controlled trial designed to measure the efficacy of Beyfortus against medically attended lower respiratory tract disease (LRTD) caused by RSV through 150 days post-dose in healthy preterm infants of 29 to less than 35 weeks gestation (n=1,453). Infants were randomized (2:1) to receive a single 50 mg intramuscular injection of Beyfortus (n=969) or placebo (n=484) regardless of weight at the RSV season start. The primary endpoint was met, significantly reducing the incidence of medically attended RSV LRTD by 70.1% (95% CI: 52.3, 81.2; P<0.001) compared to placebo. In a prespecified secondary endpoint, Beyfortus reduced medically attended RSV LRTD with hospitalization by 78.4% (95% CI 51.9, 90.3) versus placebo. The Beyfortus dosing regimen was determined based on further exploration of the Phase 2b data and was used in subsequent trials as a single 50 mg dose for those who weigh less than 5 kg, or a single 100 mg dose for those who weigh 5 kg or greater. A post-hoc analysis of the Phase 2b study that applied the recommended 50 mg dose in a subgroup of infants weighing less than 5 kg showed the efficacy of Beyfortus against medically attended RSV LRTD and medically attended RSV LRTD with hospitalization was 86.2% (95% CI 68.0, 94.0) and 86.5%(95% CI 53.5, 96.1), respectively. The Phase 3 MELODY trial (Trial 04) was a randomized, double-blind, placebo-controlled trial conducted across 21 countries designed to determine the safety and efficacy of Beyfortus against medically attended LRTD caused by RSV in healthy term and late preterm infants (35 weeks gestational age or greater) entering their first RSV season, including efficacy against severe disease such as hospitalization, through 150 days after dosing. The primary endpoint was met, reducing the incidence of medically attended RSV LRTD by 74.9% (95% CI 50.6, 87.3; P<0.001) compared to placebo. The efficacy of Beyfortus against the secondary endpoint of hospitalization was 60.2% (95% CI: -14.6, 86.2). MEDLEY (Trial 05) was a Phase 2/3, randomized, double-blind, palivizumab-controlled trial with the primary objective of assessing safety and tolerability for Beyfortus in preterm infants of less than 35 weeks gestational age and infants with congenital heart disease (CHD) and/or chronic lung disease (CLD) of prematurity eligible to receive palivizumab. Between July 2019 and May 2021, a total of 925 infants at higher risk for severe RSV disease entering their first RSV season were randomized to receive Beyfortus or palivizumab. Safety was assessed by monitoring the occurrence of treatment emergent adverse events (TEAEs) and treatment emergent severe adverse events (TESAEs) through 360 days post-dose. Serum levels of Beyfortus following dosing (on day 151) in this trial were comparable with those observed in the Phase 3 MELODY trial (Trial 04), indicating similar protection in this population to that in healthy term and late preterm infants is likely. The safety profile of Beyfortus was similar to palivizumab in the MEDLEY Phase 2/3 trial and consistent with the safety profile in healthy term, late preterm and preterm infants compared to placebo across the MELODY and Phase 2b trials. While uncommon, the most reported adverse reactions were rash 14 days post-dose, (the majority of which were mild to moderate) and non-serious injection site reactions within 7 days post-dose. The results of MELODY, Phase 2/3 MEDLEY and the Phase 2b trials illustrate that Beyfortus helps protect infants during their first RSV season against RSV disease with a single dose. This all-infant population includes healthy term, late preterm, and preterm infants, as well as infants with specific health conditions that make them vulnerable to severe RSV disease. These trials form the basis of regulatory submissions that began in 2022. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Media RelationsSandrine Guendoul | + 33 6 25 09 14 25 | sandrine.guendoul@sanofi.comSally Bain | + 1 617 834 6026 | sally.bain@sanofi.comEvan Berland | +1 215 432 0234 | evan.berland@sanofi.comNicolas Obrist | + 33 6 77 21 27 55 | nicolas.obrist@sanofi.com Investor RelationsEva Schaefer-Jansen | + 33 7 86 80 56 39 | eva.schaefer-jansen@sanofi.comArnaud Delepine | + 33 6 73 69 36 93 | arnaud.delepine@sanofi.comCorentine Driancourt | + 33 6 40 56 92 21 | corentine.driancourt@sanofi.comFelix Lauscher | + 1 908 612 7239 | felix.lauscher@sanofi.comTarik Elgoutni| + 1 617 710 3587 | tarik.elgoutni@sanofi.comNathalie Pham | + 33 7 85 93 30 17 | nathalie.pham@sanofi.com Sanofi Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words expects, anticipates, believes, intends, estimates, plans and similar expressions. Although Sanofis management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofis ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that pandemics or other global crises may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under Risk Factors and Cautionary Statement Regarding Forward-Looking Statements in Sanofis annual report on Form 20-F for the year ended December 31, 2022. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. References1.Leader S, Kohlhase K. Recent trends in severe respiratory syncytial virus (RSV) among US infants, 1997 to 2000. J Pediatr. 2003;143(5 Suppl):S127-S132. doi:10.1067/s0022-3476(03)00510-9.2.Zhou H, et al. Hospitalizations associated with influenza and respiratory syncytial virus in the United States, 1993-2008. Clin Infect Dis. 2012;54:14271436.3.Rainisch G, et al. Estimating the impact of multiple immunization products on medically- attended respiratory syncytial virus (RSV) infections in infants. Vaccine. 2020;38(2):251-257. https://doi.org/10.1016/j.vaccine.2019.10.0234.Centers for Disease Control and Prevention. RSV in Infants and Young Children. https://www.cdc.gov/rsv/high-risk/infants-young-children.html. Accessed July 2023.5.Walsh, EE. Respiratory Syncytial Virus Infection: An Illness for All Ages. Clinics in Chest Medicine. 2017;38(1):29-36. https://doi.org/10.1016/j.ccm.2016.11.010.6.Esposito S, et al. RSV Prevention in All Infants: Which Is the Most Preferable Strategy? Front Immunol. 2022; 13: 880368. doi: 10.3389/fimmu.2022.880368.7.Centers for Disease Control and Prevention. Vaccines & Immunizations. August 18, 2017. https://www.cdc.gov/vaccines/vac-gen/immunity-types.htm. Accessed July 2023. Attachment Press_Release Source: West Corporation Jun 29, 2023: Banco Santander Press Release: Vaccines R&D pipeline raises the bar in RSV, influenza, meningitis, and pneumococcal disease Vaccines Investor EventVaccines R&D pipeline raises the bar in RSV, influenza, meningitis, and pneumococcal disease Sanofi reaffirms ambition to deliver >10bn in annual vaccines sales by 2030, fueled by an accelerated pace of innovationIntent to start at least 5 innovative Phase 3 vaccine programs by 2025 Paris, June 29, 2023. Today Sanofi is hosting a Vaccines Investor Event dedicated to its pipeline with key members of its leadership team. The event will highlight how Sanofis strategy is supported by vaccines R&D. Since 2019, reinvesting in key growth drivers and a renewed pipeline has positioned the company well as it moves at speed on the second phase of its Play to Win strategy. Sustained growth in the vaccines business will be driven by core franchises of influenza, meningitis, and pediatric vaccines, with the addition of a best-in-class RSV franchise that aims to protect infants, toddlers and older adults. Sanofi has made strides in bolstering its vaccines R&D, including the rapid development of a leading-edge mRNA platform, coupled with a global footprint of industrial and commercial expertise.Thomas Triomphe Executive Vice President, Vaccines, SanofiToday, were pleased to showcase how vaccines R&D is significantly contributing to the continued growth of the company through the design, development, and delivery of vaccines that address unmet needs. The pace of our innovation is buoyed both by a sense of urgency to address existing public health needs at multiple stages in life, and by our continued transformation as a company that simply wont accept good enough. In less than two years, Sanofi has delivered a competitive mRNA platform with improved potency and thermostability that performs with both viral and bacterial targets. Using a powerful internal and external innovation ecosystem, Sanofis mRNA Center of Excellence has accelerated the science of mRNA technology, including improved lipid nanoparticles. Jean-Francois ToussaintGlobal Head of Vaccines R&D, SanofiWith the addition of mRNA, we now have the largest development toolbox in the industry. This allows us to tackle public health challenges like RSV across multiple stages of life, applying the right platform to the right age group. Adding machine learning and antigen design means that our future vaccines will raise the bar beyond todays high standards. With a clear focus on delivering only first- and best-in-class vaccines, were wholly focused on innovative R&D and flawless execution. New data from 12 assets in Sanofis broad vaccines pipeline will be featured today: Latest data from across the RSV development program, including Phase 3b HARMONIE data for Beyfortus (nirsevimab), specifically designed to protect all infants against RSV when entering their first season; positive Phase 1/2 data from the first RSV vaccine designed to protect toddlers (SP0125); and positive Phase 1/2 results from the RSV mRNA vaccine in older adults (SP0256), which lays the foundation for clinical investigation of a combination vaccine with up to three different pathogens (for example, Respiratory Syncytial Virus, human Metapneumovirus, Parainfluenza virus) for older adults.First data from the mRNA Flu Quadrivalent vaccine, and promising results of the next-generation neuraminidase-encoding mRNA Flu vaccine, supporting further development of this novel program.Latest data from the Phase 1/2 pediatric pneumococcal vaccine program (SP0202/ developed in collaboration with SK Biosciences), with positive safety and immunogenicity of the first PCV21 vaccine, designed to extend protection against disease with an innovative carrier that breaks the glass ceiling of serotype compositions. Phase 3 start of pediatric pneumococcal vaccine planned in H1 2024, with expected submission for approval in 2027.Sanofi will share recent clinical evidence reinforcing MenQuadfis best-in-class profile and unique ready-to-use syringe in the fight against meningitis. FDA submission of MenQuadfi first and only ready-to-use syringe scheduled for July 2023, with expected launch in 2024. In addition, positive Phase 1/2 results from the Men B program (SP0230) will be presented, supporting a move to the next phase of development.In the realm of new frontiers, Sanofi will introduce initial data from its multi-antigen chlamydia vaccine candidate, which will move to Phase 1/2 in early 2024; and preclinical results with its therapeutic mRNA vaccine candidate against acne, which moves into Phase 1/2 in H2, 2023. Vaccines Investor Event details Webcast and presentation will be accessible here. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Media RelationsSandrine Guendoul|+ 33 6 25 09 14 25 |sandrine.guendoul@sanofi.comSally Bain|+ 1 617 834 6026 |sally.bain@sanofi.comEvan Berland | +1 215 432 0234 | evan.berland@sanofi.comVictor Rouault|+ 33 6 70 93 71 40 |victor.rouault@sanofi.com Investor RelationsEva Schaefer-Jansen|+ 33 7 86 80 56 39 |eva.schaefer-jansen@sanofi.comArnaud Delepine|+ 33 6 73 69 36 93 | arnaud.delepine@sanofi.comCorentine Driancourt|+ 33 6 40 56 92 21 | corentine.driancourt@sanofi.comFelix Lauscher|+ 1908612 7239 | felix.lauscher@sanofi.comTarik Elgoutni| + 1 617 710 3587 | tarik.elgoutni@sanofi.comNathalie Pham|+ 33 7 85 93 30 17 | nathalie.pham@sanofi.com Sanofi Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words expects, anticipates, believes, intends, estimates, plans and similar expressions. Although Sanofis management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofis ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that pandemics or other global crises may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under Risk Factors and Cautionary Statement Regarding Forward-Looking Statements in Sanofis annual report on Form 20-F for the year ended December 31, 2022. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. Attachment Press_Release Source: West Corporation Jun 25, 2023: Banco Santander Press Release: ALTUVIIIOlate-breaking data at ISTH demonstrates highly effective bleed protection in children with severe hemophilia A with once-weekly dosing ALTUVIIIOTMlate-breaking data at ISTH demonstrates highly effective bleed protection in children with severe hemophilia A with once-weekly dosing XTEND-Kids data confirm the efficacy and safety profile of ALTUVIIIO with simple, weekly 50 IU/kg dosing for both adults and childrenALTUVIIIOs expanding evidence of a first and best-in-class profile supports Sanofis commitment to delivering paradigm shifting therapies for Rare Diseases Paris, June 25, 2023. Pivotal data from the Phase 3 XTEND-Kids study evaluating ALTUVIIIOTM[Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein] once-weekly prophylaxis, a first-in-class, high-sustained factor VIII replacement therapy, in previously treated patients younger than 12 years of age with severe hemophilia A were presented today in a late-breaking session at the Annual Meeting of the International Society on Thrombosis and Haemostasis (ISTH) in Montreal, Canada. The oral presentation detailed results from the XTEND-Kids study and confirmed that ALTUVIIIO met the primary endpoint with no inhibitor development to factor VIII detected, and key secondary endpoints including annualized bleeding rate (ABR) and maintenance of factor VIII activity above pre-specified levels. In the pediatric population, clearance of administered factor concentrates in the blood is greater than in adults, often meaning injections are needed 2-4 times per week using standard (SHL) or extended half-life (EHL) factor VIII products. These data confirm that a once-weekly 50 IU/kg dose of ALTUVIIIO provides highly effective bleed protection in both children and adults and can be used across clinical scenarios. Hemophilia A is a rare, lifelong condition in which the ability of a persons blood to clot properly is impaired, leading to excessive bleeds and spontaneous bleeds into joints that can result in joint damage and chronic pain, and potentially impact quality of life. The severity of hemophilia is determined by the level of clotting factor activity in a persons blood, and there is a negative correlation between risk of bleeding and factor activity levels. ALTUVIIIO is a first-in-class, high-sustained factor VIII replacement therapyapprovedin February 2023 by the US Food and Drug Administration (FDA) for routine prophylaxis and on-demand treatment to control of bleeding episodes, as well as perioperative management (surgery) for adults and children with hemophilia A. GrantedBreakthrough Therapy designationby the FDA in May 2022 the first factor VIII therapy to receive this designation ALTUVIIIO also receivedFast Track designationin February 2021 and Orphan Drug designation in 2017. The European Commission granted Orphan Drug designation in June 2019, and the European Medicines Agency accepted the Marketing Authorization Application (MAA)for efanesoctocog alfa in May 2023. Lynn Malec, MDMedical Director of Comprehensive Center for Bleeding Disorders and Associate Investigator at The Versiti Blood Research Institute, and Associate Professor of Medicine and Pediatrics at The Medical College of WisconsinThe results from XTEND-Kids mark an important breakthrough as we strive for optimizedbleed protection as the standard of care. Achieving high-sustained factor activity with once weekly dosing means a freedom from the tradeoffs between treatment burden and efficacy we often see in treating severe hemophilia A. The reliable and consistent bleed protection ALTUVIIIO provides offers confidence for children living with hemophilia and their families to manage hemophilia with less worry. Karin Knobe, MD, PhDTherapeutic Area Head, Rare Diseases and Rare Blood Disorders, SanofiIn an effort to reduce their risk of bleeding episodes, many children living with hemophilia A are currently limited in their ability to fully participate in daily activities. This burden is compounded by the challenge of administering prophylactic treatments intravenously multiple times a week. Todays XTEND-Kids results reinforce the ability of ALTUVIIIO to provide effective bleed protection with once weekly dosing and reinforce our commitment to developing new treatment options designed to redefine the standard of care for people living with rare blood disorders. Key ResultsThe Phase 3 XTEND-Kids study (NCT04759131) was an open-label, non-randomized interventional study of the safety, efficacy, and pharmacokinetics of once-weekly ALTUVIIIO in previously treated patients younger than 12 years of age with severe hemophilia A. Patients (n=74) received once-weekly ALTUVIIIO prophylaxis (50 IU/kg) for 52 weeks. Development of Factor VIII inhibitors was not detected (0% [95% confidence interval (CI)] 04.9]). Median (interquartile range) and mean ABRs (95% CI) were 0.00 (0.001.02) and 0.89 (0.561.42), respectively64% of patients had zero bleeding episodes, 82% of patients had zero joint bleeds and 88% of patients had zero spontaneous bleedsIn this study, ALTUVIIIO was well-tolerated and demonstrated a safety profile similar to the XTEND-1 trial, confirming safety and efficacy in both adults and children. No serious allergic reactions, anaphylaxis, or embolic or thrombotic events were reported. The most common treatment-emergent adverse events (>10%) were SARS-CoV-2 test positive, upper respiratory tract infection, and fever (pyrexia). No adverse events led to treatment discontinuation. About ALTUVIIIOALTUVIIIO [Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein-ehtl] is a first-in-class high-sustained factor VIII therapy that is designed to extend protection from bleeds with once-weekly prophylactic dosing for adults and children with hemophilia A. In adults and adolescents, ALTUVIIIO has a 3 to 4 fold longer half-life relative to standard and extended half-life factor VIII products, providing high-sustained factor activity levels within normal to near-normal range, allowing for once weekly administration in both children and adults. ALTUVIIIO is the first factor VIII therapy that has been shown to break through the von Willebrand factor ceiling, which imposes a half-life limitation on earlier generation factor VIII therapies. ALTUVIIIO builds on the innovative Fc fusion technology by adding a region of von Willebrand factor and XTEN polypeptides to extend its time in circulation. About the XTEND Clinical ProgramsThe XTEND clinical program is comprised of two Phase 3 trials in hemophilia A: XTEND-1 in people 12 years or older and XTEND-Kids in children younger than 12 years old. There is also an ongoing extension study (XTEND-ed). The Phase 3 XTEND-1 study (NCT04161495) was an open-label, non-randomized interventional study assessing the safety, efficacy, and pharmacokinetics of once-weekly ALTUVIIIO in people 12 years of age or older (n=159) with severe hemophilia A who were previously treated with factor VIII replacement therapy. The study consisted of two parallel treatment arms the prophylaxis Arm A (n=133), in which patients who had received prior factor VIII prophylaxis were treated with once-weekly intravenous ALTUVIIIO prophylaxis (50 IU/kg) for 52 weeks, and the on-demand Arm B (n=26), in which patients who had received prior on-demand factor VIII therapy began with 26 weeks of on-demand ALTUVIIIO (50 IU/kg), then switched to once-weekly prophylaxis with ALTUVIIIO (50 IU/kg) for an additional 26 weeks. The primary efficacy endpoint of XTEND-1 was the mean annualized bleeding rate (ABR) in Arm A, and the key secondary endpoint was an intra-patient comparison of ABR during the ALTUVIIIO weekly prophylaxis treatment period versus the prior factor VIII prophylaxis ABR for a subset of participants in Arm A who had participated in a previous observational study (Study 242HA201/OBS16221). The XTEND-Kids study (NCT04759131) was an open-label, non-randomized interventional study of the safety, efficacy, and pharmacokinetics of once-weekly ALTUVIIIO in previously treated patients younger than 12 years of age with severe hemophilia A. Patients received once-weekly ALTUVIIIO prophylaxis (50 IU/kg) for 52 weeks. The primary endpoint was the occurrence of inhibitor development. About the Sanofi and Sobi collaborationSobi and Sanofi collaborate on the development and commercialization of Alprolixand Elocta/Eloctate. The companies also collaborate on the development and commercialization of efanesoctocog alfa, or ALTUVIIIO in the US. Sobi has final development and commercialization rights in the Sobi territory (essentially Europe, North Africa, Russia and most Middle Eastern markets). Sanofi has final development and commercialization rights in North America and all other regions in the world excluding the Sobi territory. About SobiSobi is a specialised international biopharmaceutical company transforming the lives of people with rare and debilitating diseases. Providing reliable access to innovative medicines in the areas of haematology, immunology and specialty care, Sobi has approximately 1,600 employees across Europe, North America, the Middle East, Asia and Australia. In 2022, revenue amounted to SEK 18.8 billion. Sobis share (STO:SOBI) is listed on Nasdaq Stockholm. More about Sobi atsobi.com,LinkedInandYouTube. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Media RelationsSandrine Guendoul|+ 33 6 25 09 14 25 |sandrine.guendoul@sanofi.comSally Bain|+ 1 617 834 6026 |sally.bain@sanofi.comEvan Berland | +1 215 432 0234 | evan.berland@sanofi.comVictor Rouault|+ 33 6 70 93 71 40 |victor.rouault@sanofi.com Investor RelationsEva Schaefer-Jansen|+ 33 7 86 80 56 39 |eva.schaefer-jansen@sanofi.comArnaud Delepine|+ 33 6 73 69 36 93 | arnaud.delepine@sanofi.comCorentine Driancourt|+ 33 6 40 56 92 21 | corentine.driancourt@sanofi.comFelix Lauscher|+ 1908612 7239 | felix.lauscher@sanofi.comTarik Elgoutni| + 1 617 710 3587 | tarik.elgoutni@sanofi.comNathalie Pham|+ 33 7 85 93 30 17 | nathalie.pham@sanofi.com Sanofi Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words expects, anticipates, believes, intends, estimates, plans and similar expressions. Although Sanofis management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofis ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that pandemics or other global crises may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under Risk Factors and Cautionary Statement Regarding Forward-Looking Statements in Sanofis annual report on Form 20-F for the year ended December 31, 2022. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. Attachment Press_Release Source: West Corporation Jun 22, 2023: Banco Santander Press Release: Availability of the Q2 2023 Memorandum for modelling purposes Availability of the Q2 2023 Memorandum for modelling purposes Paris, France June 22, 2023. Sanofi announced today that its Q2 2023 Memorandum for modelling purposes is available on the "Investors" page of the company's website: https://www.sanofi.com/en/investors/financial-results-and-events/financial-results/q2-results-2023 As for each quarter, Sanofi prepared this document to assist in the financial modelling of the Group's quarterly results. This document includes a reminder on various non-comparable items and exclusivity losses as well as the foreign currency impact and share count. Sanofi's second-quarter 2023 results will be published on July 28, 2023. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Media RelationsSandrine Guendoul|+ 33 6 25 09 14 25 |sandrine.guendoul@sanofi.comNicolas Obrist|+ 33 6 77 21 27 55 |nicolas.obrist@sanofi.comVictor Rouault|+ 33 6 70 93 71 40 |victor.rouault@sanofi.comSally Bain|+ 1 617 834 6026 |sally.bain@sanofi.comEvan Berland | +1 215 432 0234 | evan.berland@sanofi.com Investor RelationsEva Schaefer-Jansen|+ 33 7 86 80 56 39 |eva.schaefer-jansen@sanofi.comArnaud Delepine|+ 33 6 73 69 36 93 | arnaud.delepine@sanofi.comCorentine Driancourt|+ 33 6 40 56 92 21 | corentine.driancourt@sanofi.comFelix Lauscher|+ 1908612 7239 | felix.lauscher@sanofi.comTarik Elgoutni| + 1 617 710 3587 | tarik.elgoutni@sanofi.comNathalie Pham|+ 33 7 85 93 30 17 | nathalie.pham@sanofi.com Sanofi Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words expects, anticipates, believes, intends, estimates, plans and similar expressions. Although Sanofis management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofis ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under Risk Factors and Cautionary Statement Regarding Forward-Looking Statements in Sanofis annual report on Form 20-F for the year ended December 31, 2022. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. Attachment Press_Release Source: West Corporation Jun 20, 2023: Banco Santander Press Release: Sanofi prevails in Zantac arbitration initiated by Boehringer Ingelheim Sanofi prevails in Zantac arbitration initiated by Boehringer Ingelheim Arbitral tribunal dismisses claim brought by Boehringer Ingelheim (BI) against Sanofi for indemnification of potential liabilities related to the ongoing Zantac litigation in the U.S. ; decision is final and cannot be appealedKey U.S. federal court ruling in December 2022 found no reliable evidence that Zantac causes the alleged injuries, bolstered similar findings by FDA and EMA; tens of thousands of claimants have abandoned their claimsSanofi remains highly confident in defense of underlying U.S. Zantac litigation as confirmed by developments over the last 6 months Paris, June 20, 2023. Sanofi announces that in an International Chamber of Commerce dispute, the tribunal dismissed BIs indemnification claim against Sanofi and confirmed that Sanofi shall not be liable to indemnify BI for any potential losses in relation to the ongoing Zantac litigation in the U.S. This decision is final and non-appealable. Importantly, Sanofi remains confident that the defense of the underlying U.S. Zantac litigation is very strong. There is no reliable scientific evidence that Zantac causes the alleged injuries in the cases brought against GSK, Pfizer, BI, Sanofi, and others in the U.S. litigation. The FDA and the European Medicines Agency have both evaluated the available data and found no evidence that ranitidine, the active ingredient contained in Zantac, causes cancer. This was notably confirmed in December 2022, when a U.S. federal court assigned to oversee all federal cases in the United States (MDL) ruled that plaintiffs had no reliable scientific evidence that ranitidine can cause any of the plaintiffs alleged injuries. The thorough ruling substantiated Sanofis scientific defenses demonstrating that there is no reliable evidence of causation for even those cancer types that plaintiffs claimed had the strongest evidence. Sanofi believes that any appeal by plaintiffs of the MDL ruling has a low probability of success. Tens of thousands of claimants who were once a part of this MDL litigation chose to abandon their claims or else withdrew early from the MDL, either filing in state court or not re-filing at all. These recent events have significantly decreased the potential scope of the litigation. Background Zantac was launched in the United States as a prescription medication by GSK in 1983 (GSK continued to market the Rx version until 2017). In 1995, GSK launched an OTC version of its Zantac 75mg formula. In 1997, generic ranitidine entered the market. In 1998, Pfizer acquired the OTC rights and in 2004 it launched a 150mg version of the product as well. In 2006, BI acquired the U.S. OTC rights for Zantac and in January 2017 Sanofi acquired those OTC rights. On September 13, 2019, FDA issued a statement alerting the public that some ranitidine medicines, including over-the-counter Zantac, contained a nitrosamine impurity called N-nitrosodimethylamine (NDMA) at low levels. NDMA is a known environmental contaminant found in drinking water, soil, and common foods, including meats, dairy products, and vegetables. People are routinely exposed to small amounts of NDMA every day. In October 2019, out of an abundance of caution Sanofi issued a voluntary recall of all ranitidine Zantac OTC products in the U.S. and Canada. Since that time, the medical, scientific, and regulatory communities have extensively evaluated the safety of Zantacs active ingredient ranitidine, and the data show there is no evidence of consumer harm from real-world use of Zantac. Over time, both FDA and the European Medicines Agency have evaluated the available data and have also found no evidence that ranitidine causes cancer. Regardless of the scientific evidence, within days of FDAs September 2019 announcement, purported class actions and personal injury lawsuits were filed in U.S. courts, alleging that Zantac caused various cancers. In addition to Sanofi, these lawsuits named GSK, Pfizer, BI, dozens of generic manufacturers, retailers and pharmaceutical distributors. The arbitration dispute arose from contractual indemnification obligations agreed between Sanofi and BI as part of the January 2017 swap of Sanofis Animal Health business for BIs Consumer Health Care business. There is no evidence of consumer harm from real-world use of Zantac as a result of any NDMA contamination. Sanofi stands by the safety of Zantac. Given the lack of scientific support for plaintiffs claims, Sanofi remains fully confident in its defenses to the litigation. Sanofi acted responsibly at all times. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Media RelationsSandrine Guendoul|+ 33 6 25 09 14 25 |sandrine.guendoul@sanofi.com Evan Berland | +1 215 432 0234 | evan.berland@sanofi.comNicolas Obrist|+ 33 6 77 21 27 55 |nicolas.obrist@sanofi.comVictor Rouault|+ 33 6 70 93 71 40 |victor.rouault@sanofi.com Investor RelationsEva Schaefer-Jansen|+ 33 7 86 80 56 39 |eva.schaefer-jansen@sanofi.com Arnaud Delepine|+ 33 6 73 69 36 93 | arnaud.delepine@sanofi.comCorentine Driancourt|+ 33 6 40 56 92 21 | corentine.driancourt@sanofi.comFelix Lauscher|+ 1908612 7239 | felix.lauscher@sanofi.comTarik Elgoutni| + 1 617 710 3587 | tarik.elgoutni@sanofi.comNathalie Pham|+ 33 7 85 93 30 17 | nathalie.pham@sanofi.com Sanofi Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements are generally identified by the words expects, anticipates, believes, intends, estimates, plans and similar expressions. Although Sanofis management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact that pandemics or other global crises may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under Risk Factors and Cautionary Statement Regarding Forward-Looking Statements in Sanofis annual report on Form 20-F for the year ended December 31, 2022. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. Attachment Press_Release Source: West Corporation Jun 13, 2023: Banco Santander Press Release: Sanofi all in on artificial intelligence and data science to speed breakthroughs for patients Sanofi all in on artificial intelligence and data science to speed breakthroughs for patients Paris, June 13, 2023. Sanofi takes the next step in its company-wide digital transformation and rolls-out plai at scale. plai, Sanofis industry-leading app developed with artificial intelligence (AI) platform company Aily Labs, delivers real-time, reactive data interactions and gives an unprecedented 360 view across all Sanofi activities. The app aggregates available company internal data across functions and harnesses the power of AI to provide timely insights and personalized what if scenarios to support thousands of Sanofi teams decision makers to take informed decisions in a simple and modern digital user experience. Paul HudsonCEO, SanofiOur ambition is to become the first pharma company powered by artificial intelligence at scale, giving our people tools and technologies that focus on insights and allow them to make better everyday decisions. The use of artificial intelligence and data science already support our teams efforts in areas such as accelerating drug discovery, enhanced clinical trial design, and improving manufacturing and supply of medicines and vaccines. We have just scratched the surface as to how we embrace these disruptive technologies to achieve our ambition of transforming the practice of medicine. plai is an essential enabler in the company-wide digital transformation and data democratisation journey. AI-powered tools help Sanofi teams make better and faster data-driven decisions, hence boosting productivity across the value chain: from research to clinical operations to manufacturing and supply to business analysis. In Research, Sanofi has built multiple AI programs to slash research times through improved predictive modelling and automate time-sink activities. As a result, AI enables R&D teams to scale and accelerate ground-breaking research processes from a matter of weeks to just hours and improve potential target identification in therapeutic areas like immunology, oncology or neurology by 20 to 30%.AI also accelerates work on mRNA research. For an mRNA vaccine to reach its designated cells and produce disease-fighting proteins, it must be carried by a stable drug delivery system via a special particle, known as a lipid nanoparticle. While Sanofi owns a large library of lipid nanoparticles, R&D teams now use AI to create digital models to predict the strongest selection of particles. It increased the speed of the lipid nanoparticle prediction process from months to days. In Clinical operations, the increasing digitization and leverage of plais insights empower Sanofi teams to rethink how to run better clinical trials. For example, R&D teams can find and set up new, more convenient trial sites for their target groups, broadening opportunities for those from historically underrepresented communities to participate in clinical research. With improved representation, Sanofi continues its work toward a future where all trials reflect the diversity of the people most affected by the diseases studied. InManufacturing and Supply, Sanofiisdigitizingquality assessment processes,moving from paper to Electronic Batch Records,leveraging digital and data to improve asset utilization and increaseproductivityby implementingnew manufacturing 4.0 capabilities. Sanofihasalso developed an in-house AI-enabled yield optimization solution which learns from past and current batch performance toenableconsistently higher yield levels. This helps to optimize usage of raw materials, contributing to the companys environmental objectives, and supports improved cost efficiency. Also, recent plai adoption within Sanofi's biopharma Supply Chain has proven the ability to predict 80% of low inventory positions, allowing teams to take mitigating actions to secure supply, faster than ever before. Best-in-class technological collaborations to speed scientific breakthroughs for patients In 2022 Sanofi acquired Amunix Pharmaceuticals, which uses AI to tailor-deliver medicines that become active only in tumor tissues, while not harming normal ones. The same year, Sanofi joined forces in a collaboration with pioneering biotech Exscientia to explore new treatments for cancer and diseases linked to the immune system. Using Exscientias AI-based capabilities and personalized medicine platform, Sanofis scientists can test drug candidates against actual human tissue models, years before a clinical trial. Also in 2022, Sanofi partnered with pharmaceutical companies Insilico Medicine and Atomwise to speed up medicine development using their AI-driven platforms. This comes on top of Sanofis partnership with Owkin in 2021, whose AI-driven platform uses patient data from different medical centers to build models and predict patient responses to treatments. Sanofi @ Vivatech Sanofi is a partner of VivaTech, Europe's largest tech and startup event, taking place in Paris from June 14 to June 17, 2023. This year, Sanofi's digital experts and 17 partner startups specializing in data and e-health will show how AI and Data can push the boundaries of science. Sanofi will notably present its new groundbreaking partnership with French startup Hillo to adapt its digital twin AI solution to Sanofi's connected insulin pens. With this digital twin, the influence of the diabetic patient's lifestyle or therapeutic habits can now be taken into account in an optimized way. Sanofis Consumer Healthcare business unit will present its recently launched Open Innovation Portal, which allows the wider supply chain community to submit their solutions to unmet challenges in consumer health. Startups, entrepreneurs, research institutions, accelerators, universities and more will now be able to respond online to challenge areas that have been identified by Sanofi Consumer Healthcare, from creating sustainable packaging to developing new products and technologies. The launch of the Sanofi Consumer Healthcare Open Innovation Portal will facilitate the innovation of the very best self-care solutions by uniting the boldest and brightest external ideas with Sanofis expertise, infrastructure, scale and reach. Sanofi will continue to add new challenges to the Open Innovation Portal in the areas of digestive wellness, cough, cold and flu, physical and mental wellness, allergy, pain care, personal care and sustainability. Successful submissions will be given the opportunity to drive innovation forward together as collaborative partners on projects with Consumer Healthcare at Sanofi. Innovators can visit https://www.innovation-sanofichc.com to learn more and submit their ideas. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Media RelationsSandrine Guendoul|+ 33 6 25 09 14 25 |sandrine.guendoul@sanofi.comNicolas Obrist|+ 33 6 77 21 27 55 |nicolas.obrist@sanofi.comVictor Rouault|+ 33 6 70 93 71 40 |victor.rouault@sanofi.comSally Bain|+ 1 617 834 6026 |sally.bain@sanofi.comEvan Berland | +1 215 432 0234 | evan.berland@sanofi.comChrystel Baude|+ 33 6 70 98 70 59 |chrystel.baude@sanofi.com Investor RelationsEva Schaefer-Jansen|+ 33 7 86 80 56 39 |eva.schaefer-jansen@sanofi.comArnaud Delepine|+ 33 6 73 69 36 93 | arnaud.delepine@sanofi.comCorentine Driancourt|+ 33 6 40 56 92 21 | corentine.driancourt@sanofi.comTarik Elgoutni | + 1 617 710 3587 | tarik.elgoutni@sanofi.comFelix Lauscher|+ 1908612 7239 | felix.lauscher@sanofi.comNathalie Pham|+ 33 7 85 93 30 17 | nathalie.pham@sanofi.com Attachment Press_Release Source: West Corporation Jun 08, 2023: Banco Santander Press Release: FDA Advisory Committee unanimously recommends nirsevimab as first immunization against RSV disease for all infants FDA Advisory Committee unanimously recommends nirsevimab as first immunization against RSV disease for all infants Nirsevimab would be the first immunization specifically designed to protect all infants through their first RSV season, if approvedAcross all clinical trials, a single dose of nirsevimab delivered high, consistent and sustained efficacy and favorable safety against RSV diseaseThe FDA has indicated it will work to expedite its review; Sanofi remains committed to delivering nirsevimab in time for the 2023-2024 RSV season Paris, June 8, 2023. The U.S. Food and Drug Administration (FDA) Antimicrobial Drugs Advisory Committee (AMDAC) voted unanimously 21 to 0 that Sanofi and AstraZenecas nirsevimab has a favorable benefit risk profile for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) in newborns and infants born during or entering their first RSV season. The Committee also voted 19 to 2 in support of nirsevimabs favorable benefit risk profile for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season. Thomas Triomphe Executive Vice President, Vaccines, SanofiMost babies hospitalized with RSV are born at term and healthy, which is why interventions specifically designed to protect all infants are likely to result in the greatest impact. We are encouraged by the Advisory Committees positive vote based on the compelling clinical development program supporting nirsevimab and its breakthrough potential to reduce the magnitude of annual RSV burden. Iskra ReicExecutive Vice President, Vaccines and Immune Therapies, AstraZenecaWe are delighted that the Antimicrobial Drugs Advisory Committee has unanimously recognized the favorable benefit risk profile of nirsevimab as the first preventative option against RSV for a broad infant population. Nirsevimab builds on AstraZenecas strong science, leadership in RSV and commitment to addressing the needs of the most vulnerable. We look forward to continuing to work with the FDA to complete their expedited review, and we hope to see nirsevimab available as soon as possible given the significant burden of RSV in infants. Dr William MullerAssociate Professor, Pediatrics, Northwestern University Feinberg School of Medicine and Scientific Director, Clinical and Community Trials, Ann & Robert H. Lurie Childrens Hospital of Chicago, Illinois RSV remains the most common cause of bronchiolitis and pneumonia in infants, and the inability to predict which infants will develop severe RSV disease leads to uncertainty for new parents and for physicians. The innovation of nirsevimab as a long-acting antibody that can be conveniently administered to a broad infant population with a single dose at the time protection is most needed is a significant public health advancement that could have far-reaching impact on the well-being of our families and healthcare systems in the U.S. If approved, nirsevimab would be the first immunization specifically designed to protect all infants through their first RSV season, including those born healthy at term or preterm, or with specific health conditions that make them vulnerable to RSV disease. The single dose can be administered at the beginning of the RSV season or at birth for those born during the RSV season. The FDA accepted the Biologics License Application (BLA) for nirsevimab in 2022 and the agency has indicated it will work to expedite its review. The Prescription Drug User Fee Act date is in the third quarter of 2023. If approved by that time, nirsevimab will be available in the U.S. ahead of the 2023-2024 RSV season. The AMDAC based its recommendation on the robust nirsevimab clinical development program spanning three pivotal late-stage clinical trials, including results from the Phase 3 MELODY trial recently published in the New England Journal of Medicine. Across all clinical endpoints, a single dose of nirsevimab demonstrated high and consistent efficacy against RSV LRTD sustained through the entire RSV season. Nirsevimab was well tolerated with a favorable safety profile that was consistent across all clinical trials. The overall rates of adverse events were comparable between nirsevimab and placebo and the majority of adverse events were mild or moderate in severity. The most common adverse events were rash, fever and injection site reactions. AMDAC reviews and evaluates available data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of infectious diseases and disorders and makes appropriate recommendations to the Commissioner of Food and Drugs. The AMDACs recommendation, while not binding, will be considered by the FDA during its review of the BLA for nirsevimab. About RSVRSV is a very contagious virus that can lead to serious respiratory illness for infants, according to the Centers for Disease Control and Prevention (CDC). RSV symptoms can include runny nose, coughing, sneezing, fever, decrease in appetite, and wheezing.1 Two out of three infants are infected with RSV during their first year of life and almost all infants are infected by their second birthday.1,2 In the U.S., RSV is the leading cause of hospitalization in infants under 12 months, averaging 16 times higher than the annual rate for influenza.3,4 Approximately 75% of infants hospitalized for RSV are born healthy and at term with no underlying conditions.5 Each year in the U.S., there are an estimated 590,000 RSV disease cases in infants under one requiring medical care, including physician office, urgent care, emergency room visits and hospitalizations.6 About nirsevimabIn the U.S., nirsevimab is an investigational single-dose long-acting antibody designed to protect all infants through their first RSV season and for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season. Nirsevimab, provided directly to newborns and infants as a single dose, offers RSV protection via an antibody to help prevent lower respiratory tract disease caused by RSV. Monoclonal antibodies do not require the activation of the immune system to help offer timely, rapid and direct protection against disease.7 In March 2017, Sanofi and AstraZeneca announced an agreement to develop and commercialize nirsevimab. Under the terms of the agreement, AstraZeneca leads development and manufacturing activities, and Sanofi leads commercialization activities and records revenues. Under the terms of the global agreement, Sanofi made an upfront payment of 120m, has paid development and regulatory milestones of 55m and will pay up to a further 440m upon achievement of certain regulatory and sales-related milestones. The two companies share costs and profits in all territories except in the U.S. where Sanofi consolidates 100% of the economic benefits in its Business Operating Income. Nirsevimab has been granted special designations to facilitate expedited development by several regulatory agencies around the world. These include Breakthrough Therapy Designation and Priority Review designation by the China Center for Drug Evaluation under the National Medical Products Administration;Breakthrough Therapy Designationfrom the FDA; access granted to the European Medicines Agency (EMA)PRIority MEdicines(PRIME) scheme and EMA accelerated assessment; Promising Innovative Medicine designation by the UK Medicines and Healthcare products Regulatory Agency; and named a medicine for prioritized development under the Project for Drug Selection to Promote New Drug Development in Pediatrics by the Japan Agency for Medical Research and Development. Nirsevimab has been granted marketing authorization in the European Union, Great Britain and Canada for the prevention of RSV lower respiratory tract disease in newborns and infants from birth through their first RSV season and is currently undergoing regulatory review in the U.S. In Canada, nirsevimab is also approved for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season and such indication is under review at the EMA level. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Media RelationsSandrine Guendoul|+ 33 6 25 09 14 25 |sandrine.guendoul@sanofi.comSally Bain|+ 1 617 834 6026 |sally.bain@sanofi.comEvan Berland | +1 215 432 0234 | evan.berland@sanofi.comNicolas Obrist|+ 33 6 77 21 27 55 |nicolas.obrist@sanofi.com Investor RelationsEva Schaefer-Jansen|+ 33 7 86 80 56 39 |eva.schaefer-jansen@sanofi.comArnaud Delepine|+ 33 6 73 69 36 93 | arnaud.delepine@sanofi.comCorentine Driancourt|+ 33 6 40 56 92 21 | corentine.driancourt@sanofi.comTarik Elgoutni | + 1 617 710 3587 | tarik.elgoutni@sanofi.comFelix Lauscher|+ 1908612 7239 | felix.lauscher@sanofi.comNathalie Pham|+ 33 7 85 93 30 17 | nathalie.pham@sanofi.com Sanofi Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words expects, anticipates, believes, intends, estimates, plans and similar expressions. Although Sanofis management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofis ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that pandemics or other global crises may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under Risk Factors and Cautionary Statement Regarding Forward-Looking Statements in Sanofis annual report on Form 20-F for the year ended December 31, 2022. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. References Attachment Press_Release Source: West Corporation May 21, 2023: Banco Santander Press Release: Dupixent (dupilumab) late-breaking Phase 3 COPD results presented at ATS and simultaneously published in the New England Journal of Medicine Dupixent (dupilumab) late-breaking Phase 3 COPD results presented at ATS and simultaneously published in the New England Journal of Medicine Dupixent is the first and only investigational biologic for COPD that has demonstrated a significant reduction in moderate or severe acute exacerbations by 30% compared to placeboDupixent is the first and only investigational biologic for COPD that has significantly improved lung function at 12 and 52 weeks, with numerical improvements seen as early as 2 weeksDupixent significantly improved quality of life, with numerical improvements as early as 4 weeks after initiating treatment, and respiratory symptoms COPD is the third leading cause of death worldwide, with no new treatment approaches approved in more than a decade; trial enrolled patients with moderate-to-severe disease and evidence of type 2 inflammation (i.e., blood eosinophils 300 cells/L) Paris and Tarrytown, N.Y. May 21, 2023. Positive Phase 3 results evaluating the investigational use of Dupixent (dupilumab) compared to placebo in adults currently on maximal standard-of-care inhaled therapy (triple therapy) with uncontrolled chronic obstructive pulmonary disease (COPD) and evidence of type 2 inflammation were shared today in the 2023 American Thoracic Society (ATS) International Conference session New England Journal of Medicine and JAMA. Discussion on the Edge: Reports of Recently Published Pulmonary Research and simultaneously published in the New England Journal of Medicine (NEJM). These results will also be presented in the Breaking News: Clinical Trial Results in Pulmonary Medicine session on May 22. Surya Bhatt, M.D., MSPHAssociate Professor at the University of Alabama at Birmingham Division of Pulmonary, Allergy, and Critical Care Medicine, and a co-principal investigator of the trial"I've seen patients with uncontrolled chronic obstructive pulmonary disease struggle for far too long with the debilitating symptoms of this progressive disease with limited, incremental improvement on current treatment options. This trial showed that dupilumab has the potential to impact the vicious cycle of exacerbations and lung function decline in patients with uncontrolled COPD with type 2 inflammation, and significantly improve respiratory symptoms. Dupilumab also helped improve health-related quality of life measures, which, from my years of experience as a physician, are just as meaningful for patients as being able to breathe easier. COPD is a life-threatening respiratory disease that damages the lungs and causes progressive lung function decline. Symptoms include persistent cough and breathlessness that may not only impair the ability to perform routine daily activities, but can also lead to anxiety, depression and sleep disturbances. COPD is also associated with a significant health and economic burden due to recurrent acute exacerbations that require systemic corticosteroid treatment and/or lead to hospitalization or even death. Smoking and exposure to noxious particles are key risk factors for COPD, but even individuals who quit smoking can still develop or continue having the disease. In the U.S. alone, approximately 300,000 people live with uncontrolled COPD with evidence of type 2 inflammation. The results presented at ATS and published in NEJM are from the BOREAS trial, which met the primary and all key secondary endpoints. As presented and published, patients receiving Dupixent (n=468) compared to placebo (n=471) added to maximal standard-of-care inhaled triple therapy experienced a: 30% reduction in moderate or severe acute COPD exacerbations over 52 weeks (p<0.001), the primary endpoint.160 mL improvement in lung function from baseline at 12 weeks versus 77 mL (p<0.001). Numerical improvements were observed as early as 2 weeks, with the benefit versus placebo sustained through 52 weeks (Dupixent: 153 mL, placebo: 70 mL; p<0.001). 9.7-point improvement in health-related quality of life (QoL; patient-reported outcome on a scale from 0-100) from baseline at 52 weeks versus a 6.4-point improvement (p=0.002), with numerical improvements observed as early as 4 weeks. 2.7-point reduction in respiratory symptom severity (patient-reported outcome on a scale from 0-40) from baseline at 52 weeks versus a 1.6-point reduction (p=0.001). In a pre-specified analysis from a subgroup of patients (Dupixent n=195, placebo n=188) with elevated levels (20 ppb) of fractional exhaled nitric oxide (FeNO) an airway biomarker of type 2 inflammation Dupixent treatment also led to a significant 38% reduction in exacerbations compared to placebo at 52 weeks (p=0.005). In this subgroup, Dupixent also led to an improvement in lung function of 232 mL versus 108 mL for placebo at 12 weeks (p=0.002) that was sustained at 52 weeks with an improvement in lung function of 247 mL versus 120 mL for placebo (p=0.003). The safety results were generally consistent with the known safety profile of Dupixent in its approved indications. Overall rates of adverse events (AEs) were 77% for Dupixent and 76% for placebo. AEs more commonly observed with Dupixent compared to placebo included headache (8.1% Dupixent, 6.8% placebo), diarrhea (5.3% Dupixent, 3.6% placebo) and back pain (5.1% Dupixent, 3.4% placebo). AEs more commonly observed with placebo compared to Dupixent included upper respiratory tract infection (9.8% placebo, 7.9% Dupixent), hypertension (6.0% placebo, 3.6% Dupixent) and COVID-19 (5.7% placebo, 4.1% Dupixent). AEs leading to deaths were balanced between the two arms (1.7% placebo, 1.5% Dupixent). The second, replicate Phase 3 trial of Dupixent in COPD with evidence of type 2 inflammation (NOTUS) is ongoing, with data expected in 2024. The safety and efficacy of Dupixent in COPD are currently under clinical investigation and have not been evaluated by any regulatory authority. Sanofi and Regeneron look forward to discussing the BOREAS data with regulators. About the Dupixent COPD Phase 3 Trial ProgramBOREAS is one of two pivotal trials in the Dupixent COPD program. The randomized, Phase 3, double-blind, placebo-controlled trial evaluated the efficacy and safety of Dupixent in 939 adults who were current or former smokers aged 40 to 80 years with moderate-to-severe COPD. All patients in the trial had evidence of type 2 inflammation, as measured by blood eosinophils 300 cells/L. Patents with a diagnosis or history of asthma were excluded from the trial. During the 52-week treatment period, patients received Dupixent or placebo every two weeks added to a maximal standard-of-care inhaled triple therapy of inhaled corticosteroids (ICS), long-acting beta agonists, and long-acting muscarinic antagonists. Double maintenance therapy was allowed if ICS was contraindicated. The primary endpoint evaluated the annualized rate of acute moderate or severe COPD exacerbations. Moderate exacerbations were defined as those requiring systemic steroids and/or antibiotics. Severe exacerbations were defined as those: requiring hospitalization; requiring more than a day of observation in an emergency department or urgent care facility; or resulting in death. Key secondary and other hierarchy endpoints included: Change from baseline in lung function (assessed by pre-bronchodilator forced expiratory volume over one second [FEV1]) at 12 and 52 weeks in both the overall population and those with FeNO 20 ppb. Change from baseline at 52 weeks in St. Georges Respiratory Questionnaire (SGRQ) total score compared to placebo (scale from 0-100). Change from baseline at 52 weeks in the Evaluating Respiratory Symptoms in COPD (E-RS: COPD) scale score (scale from 0-40).The annualized rate of acute moderate or severe COPD exacerbations in patients with FeNO 20 ppb. About Sanofi and Regenerons COPDClinical Research ProgramSanofi and Regeneron are motivated to transform the treatment paradigm of COPD by examining the role different types of inflammation play in the disease progression through the investigation of two potentially first-in-class biologics, Dupixent and itepekimab. Dupixent inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and the program focuses on a specific population of people with evidence of type 2 inflammation. Itepekimab is a fully human monoclonal antibody that binds to and inhibits interleukin-33 (IL-33), an initiator and amplifier of broad inflammation in COPD. Across both programs, four Phase 3 trials are ongoing and designed to inform next-generation treatments for people with COPD who might not have other options. Itepekimab is currently under clinical investigation and its safety and efficacy have not been evaluated by any regulatory authority. About DupixentDupixent is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not an immunosuppressant. The Dupixent development program has shown significant clinical benefit and a decrease in type 2 inflammation in Phase 3 trials, establishing that IL-4 and IL-13 are key and central drivers of the type 2 inflammation that plays a major role in multiple related and often co-morbid diseases. These diseases include approved indications for Dupixent, such as atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), eosinophilic esophagitis (EoE) and prurigo nodularis. Dupixent has received regulatory approvals in one or more countries around the world for use in certain patients with atopic dermatitis, asthma, CRSwNP, EoE or prurigo nodularis in different age populations. Dupixent is currently approved for one or more of these indications in more than 60 countries, including in Europe, the U.S. and Japan. More than 600,000 patients are being treated with Dupixent globally. Dupilumab Development ProgramDupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement. To date, dupilumab has been studied across more than 60 clinical trials involving more than 10,000 patients with various chronic diseases driven in part by type 2 inflammation. In addition to the currently approved indications, Sanofi and Regeneron are studying dupilumab in a broad range of diseases driven by type 2 inflammation or other allergic processes in Phase 3 trials, including pediatric EoE, chronic spontaneous urticaria, chronic pruritus of unknown origin, chronic obstructive pulmonary disease with evidence of type 2 inflammation and bullous pemphigoid. These potential uses of dupilumab are currently under clinical investigation, and the safety and efficacy in these conditions have not been fully evaluated by any regulatory authority. About RegeneronRegeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led for 35 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, hematologic conditions, infectious diseases and rare diseases. Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite technologies, such as VelocImmune, which uses unique genetically humanized mice to produce optimized fully human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world. For more information, please visit www.Regeneron.com or follow @Regeneron on Twitter. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY. Media RelationsSandrine Guendoul | + 33 6 25 09 14 25 | sandrine.guendoul@sanofi.comSally Bain|+ 1 617 834 6026 |sally.bain@sanofi.com Investor RelationsEva Schaefer-Jansen|+ 33 7 86 80 56 39 |eva.schaefer-jansen@sanofi.comArnaud Delepine|+ 33 6 73 69 36 93 | arnaud.delepine@sanofi.comCorentine Driancourt|+ 33 6 40 56 92 21 | corentine.driancourt@sanofi.comFelix Lauscher|+ 1908612 7239 | felix.lauscher@sanofi.comTarik Elgoutni| + 1 617 710 3587 | tarik.elgoutni@sanofi.comNathalie Pham|+ 33 7 85 93 30 17 | nathalie.pham@sanofi.com Regeneron Media RelationsSharon Chen | +1 914-847-1546 | sharon.chen@regeneron.com Regeneron Investor RelationsVesna Tosic | + 914 847 5443 | vesna.tosic@regeneron.com Sanofi Disclaimers or Forward-Looking Statements This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements are generally identified by the words expects, anticipates, believes, intends, estimates, plans and similar expressions. Although Sanofis management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact that pandemics or other global crises may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under Risk Factors and Cautionary Statement Regarding Forward-Looking Statements in Sanofis annual report on Form 20-F for the year ended December 31, 2022. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. Regeneron Forward-Looking Statements and Use of Digital Media This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. (Regeneron or the Company), and actual events or results may differ materially from these forward-looking statements. Words such as anticipate, expect, intend, plan, believe, seek, estimate, variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, Regenerons Products) and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, Regenerons Product Candidates) and research and clinical programs now underway or planned, including without limitation Dupixent; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regenerons Product Candidates and new indications for Regenerons Products, such as Dupixent for the treatment of chronic obstructive pulmonary disease with evidence of type 2 inflammation as discussed in this press release as well as for the treatment of pediatric eosinophilic esophagitis, chronic spontaneous urticaria, chronic pruritus of unknown origin, bullous pemphigoid, and other potential indications; uncertainty of the utilization, market acceptance, and commercial success of Regenerons Products and Regenerons Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary), including the studies discussed or referenced in this press release, on any of the foregoing or any potential regulatory approval of Regenerons Products (such as Dupixent) and Regenerons Product Candidates; the ability of Regenerons collaborators, licensees, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regenerons Products and Regenerons Product Candidates; the ability of Regeneron to manage supply chains for multiple products and product candidates; safety issues resulting from the administration of Regenerons Products (such as Dupixent) and Regenerons Product Candidates in patients, including serious complications or side effects in connection with the use of Regenerons Products and Regenerons Product Candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict Regenerons ability to continue to develop or commercialize Regenerons Products and Regenerons Product Candidates, including without limitation Dupixent; ongoing regulatory obligations and oversight impacting Regenerons Products, research and clinical programs, and business, including those relating to patient privacy; the availability and extent of reimbursement of Regenerons Products from third-party payers, including private payer healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payers and new policies and procedures adopted by such payers; competing drugs and product candidates that may be superior to, or more cost effective than, Regenerons Products and Regenerons Product Candidates; the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators or licensees may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license, collaboration, or supply agreement, including Regenerons agreements with Sanofi and Bayer (or their respective affiliated companies, as applicable) to be cancelled or terminated; the impact of public health outbreaks, epidemics, or pandemics (such as the COVID-19 pandemic) on Regeneron's business; and risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA (aflibercept) Injection, Praluent (alirocumab), and REGEN-COV (casirivimab and imdevimab)), other litigation and other proceedings and government investigations relating to the Company and/or its operations, the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regenerons business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regenerons filings with the U.S. Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2022 and its Form 10-Q for the quarterly period ended March 31, 2023. Any forward-looking statements are made based on managements current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise.Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regenerons media and investor relations website (http://newsroom.regeneron.com) and its Twitter feed (http://twitter.com/regeneron). Attachment Source: West Corporation May 12, 2023: Banco Santander Press Release: Nirsevimab delivers 83% reduction in RSV infant hospitalizations in a real-world clinical trial setting Nirsevimab delivers 83% reduction in RSV infant hospitalizations in a real-world clinical trial setting HARMONIE Phase 3b data reinforce nirsevimabs consistent and high efficacy against infant hospitalizations due to RSVData presented at ESPID add to the body of evidence demonstrating nirsevimabs protection against RSV-related lower respiratory tract disease (LRTD) and confirm its favorable safety profile in multi-country, real-world conditions Paris, May 12, 2023. New data from the HARMONIE Phase 3b clinical trial show an 83.21% (95% CI 67.77 to 92.04; P<0.001) reduction in hospitalizations due to RSV-related LRTD in infants under 12 months of age who received a single dose of nirsevimab, compared to infants who received no RSV intervention.1 The Hospitalized RSV Monoclonal Antibody Prevention (HARMONIE) study is a large, multi-country European interventional clinical trial aiming to determine the efficacy and safety of a single intramuscular dose of nirsevimab, with data collected in a real-world setting during the 2022-2023 RSV season.1 The trial recruited more than 8,000 infants and took place at nearly 250 sites across France, Germany and the United Kingdom. The data from HARMONIE were presented at the 41st Annual Meeting of the European Society for Paediatric Infectious Diseases (ESPID). Thomas TriompheExecutive Vice President, Vaccines, Sanofi This winter saw higher rates of RSV-related infant hospitalizations than during pandemic or pre-pandemic years. The HARMONIE data demonstrate the real-world impact nirsevimab has on pediatric hospitalizations, and illustrate its importance for infants, their families and public health. Dr Simon DrysdaleConsultant Pediatrician in Infectious Diseases at St. Georges University Hospital NHS Foundation Trust and Co-Chief Investigator of HARMONIERSV-related chest infections lead to high numbers of infants under 12 months old being hospitalized every year. These data reinforce the potential public health benefit of nirsevimab in terms of helping to reduce the strain on hospitals caused each year by RSV. The data from HARMONIE also show that nirsevimab reduced the incidence of hospitalizations due to severe RSV-related LRTD (patients whose oxygen level is under 90% and require oxygen supplementation) by 75.71% (95% CI 32.75 to 92.91; P<0.001).1 Additionally, nirsevimab demonstrated a reduction of 58.04% (95% CI 39.69 to 71.19; P<0.001) in the incidence of all-cause LRTD hospitalization compared to infants who received no RSV intervention.1 This means the overall burden on healthcare systems could be reduced significantly if all infants receive nirsevimab. RSV-related direct medical costs, globally including hospital, outpatient and follow-up care were estimated at 4.82 billion in 2017.2 Throughout HARMONIE, nirsevimab maintained a favorable safety profile, consistent with the pivotal trial results. About RSV RSV is the most common cause of LRTD, including bronchiolitis and pneumonia, in infants.5-8 It is also a leading cause of hospitalization in all infants, with most hospitalizations for RSV occurring in healthy infants born at term.9-12 Globally, in 2019, there were approximately 33 million cases of acute lower respiratory infections leading to more than three million hospitalizations, and it was estimated that there were 26,300 in-hospital deaths of children younger than five years.12 About HARMONIE The Hospitalized RSV Monoclonal Antibody Prevention (HARMONIE) study is a large European interventional clinical trial aiming to determine the efficacy and safety of a single intramuscular (IM) dose of nirsevimab (<5 kg 50 mg; 5 kg 100 mg), compared to no intervention (standard of care), for the prevention of hospitalizations due to RSV-related LRTD in infants under 12 months of age who are not eligible to receive palivizumab. Sanofi and academic investigators worked together to design and deliver HARMONIE with digital solutions to minimize the burden on families, site staff and health systems. The trial opened at nearly 250 sites, supported by National Institute of Health Research infrastructure (UK), the PEDSTART network (France) and NETSTAP e.V.(Germany) and has recruited over 8000 infants.13 The primary efficacy data for HARMONIE were collected during the 2022-2023 RSV season.1 Participant follow-up will conclude at 12 months. About Nirsevimab Nirsevimab, a long-acting antibody designed for all infants for protection against RSV disease from birth through their first RSV season with a single dose, is being developed jointly by Sanofi and AstraZeneca. Nirsevimab has been developed to offer newborns and infants direct RSV protection via an antibody to help prevent medically attended lower respiratory tract infections caused by RSV. Monoclonal antibodies do not require the activation of the immune system to help offer timely, rapid and direct protection against the disease.14 Nirsevimab has been granted special designations to facilitate expedited development by several regulatory agencies around the world. These include Breakthrough Therapy Designation by The China Center for Drug Evaluation under the National Medical Products Administration; Breakthrough Therapy Designation from the U.S. Food and Drug Administration; access granted to the European Medicines Agency (EMA) PRIority MEdicines (PRIME) scheme; Promising Innovative Medicine designation by the UK Medicines and Healthcare products Regulatory Agency;15 and has been named a medicine for prioritized development under the Project for Drug Selection to Promote New Drug Development in Pediatrics by the Japan Agency for Medical Research and Development (AMED). The safety and efficacy of nirsevimab was evaluated under an accelerated assessment procedure by the EMA. Nirsevimab has been granted marketing authorization in the European Union, the United Kingdom and Canada for the prevention of RSV lower respiratory tract disease in newborns and infants from birth through their first RSV season and is currently undergoing regulatory review in the U.S. In Canada, Beyfortus is also approved for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season. In March 2017, Sanofi and AstraZeneca announced an agreement to develop and commercialize nirsevimab. Under the terms of the agreement, AstraZeneca leads development and manufacturing activities, and Sanofi leads commercialization activities and record revenues. Under the terms of the global agreement, Sanofi made an upfront payment of 120m, has paid development and regulatory milestones of 55m and will pay up to a further 440m upon achievement of certain regulatory and sales-related milestones. The two companies share costs and profits in all territories except in the US where Sanofi consolidate 100% of the economic benefits in its Business Operating Income. About Sanofi We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Media RelationsSandrine Guendoul | + 33 6 25 09 14 25 | sandrine.guendoul@sanofi.comSally Bain | + 1 617 834 6026 | sally.bain@sanofi.comEvan Berland | + 1 215 432 0234 | evan.berland@sanofi.comNicolas Obrist|+ 33 6 77 21 27 55 |nicolas.obrist@sanofi.com Investor RelationsEva Schaefer-Jansen | + 33 7 86 80 56 39 | eva.schaefer-jansen@sanofi.comArnaud Delepine | + 33 6 73 69 36 93 | arnaud.delepine@sanofi.comCorentine Driancourt | + 33 6 40 56 92 21 | corentine.driancourt@sanofi.comFelix Lauscher | + 1 908 612 7239 | felix.lauscher@sanofi.comTarik Elgoutni| + 1 617 710 3587 | tarik.elgoutni@sanofi.comNathalie Pham | + 33 7 85 93 30 17 | nathalie.pham@sanofi.com Sanofi Forward-Looking Statements This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words expects, anticipates, believes, intends, estimates, plans and similar expressions. Although Sanofis management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofis ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that pandemics or other global crises may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under Risk Factors and Cautionary Statement Regarding Forward-Looking Statements in Sanofis annual report on Form 20-F for the year ended December 31, 2022. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. References Attachment Press_Release Source: West Corporation Apr 27, 2023: Banco Santander Press Release: Strong Q1 growth driven by Specialty Care, Vaccines and CHC Strong Q1 growth driven by Specialty Care, Vaccines and CHC Paris, April 27, 2023 Q1 2023 sales growth of 5.5% at CER and business EPS(1) growth of 11.9% at CER Specialty Care grew 18.3% driven by Dupixent (2,316 million, +39.7%) and Rare Disease Vaccines up 15.2% reflecting recovery of Booster and Travel vaccines and COVID vaccine shipments in Europe General Medicines sales lower (-11.4%) mainly due to Lantus and divestments, core assets growing 1.6%CHC sales of 1,495 million increased by 11.2% with price and favorable phasing as main contributorsBusiness EPS(1) of 2.16 up 11.3% on a reported basis and 11.9% at CER IFRS EPS of 1.60 (down 0.6%) Key R&D milestones and regulatory achievements in Q1 ALTUVIIIO approved by the FDA for the treatment of adults and children with hemophilia ATwo additional approvals for Dupixent in Europe (EoE from 12 years and AD in 6 months and older)Dupixent accepted for review in the U.S. and Japan for the treatment of CSUDupixent met primary and all secondary endpoints in its first phase 3 study in patients with COPD Progress on Corporate Social Responsibility strategy in Q1 Sanofi partnering with Ghana Ministry of Health to improve affordable access to diabetes careNet Zero(2) by 2045 and updated scope 3 targets validated by Science Based Targets Initiative (SBTi) Full-year 2023 business EPS guidance confirmed Paul Hudson, Sanofi Chief Executive Officer, commented: We have started 2023 with strong results, delivering double-digit sales growth across our Specialty Care, Vaccines and Consumer Healthcare businesses. Dupixent continues its compelling performance and is on track to achieve its 10 billion sales objective for this year. The unique product profile of Dupixent was further underscored by highly positive pivotal results in uncontrolled chronic obstructive pulmonary disease, which we are looking forward to discuss with regulators. We are also advancing our early-to-mid stage pipeline and plan to feature several promising candidates at upcoming R&D investor events. For the remainder of the year, we are confident in our business outlook, while navigating the impact from generic versions of Aubagio, our last meaningful patent expiry this decade, with generics entering the U.S. market at the end of Q1. With the U.S. launch of ALTUVIIIO now underway and the anticipated roll-out of Beyfortus in time for the RSV season later this year, we keep executing on our Play to Win growth strategy. Changes in net sales are expressed at constant exchange rates (CER) unless otherwise indicated (definition in Appendix 7). (1) In order to facilitate an understanding of operational performance, Sanofi comments on the business net income statement. Business net income is a non-GAAP financial measure (definition in Appendix 7). The consolidated income statement for Q1 2023 is provided in Appendix 3 and a reconciliation of reported IFRS net income to business net income is set forth in Appendix 4; (2) refer to ESG section for Sanofi Net Zero definition; (3) 2022 business EPS was 8.26; (4) Free cash flow is a non-GAAP financial measure (definition in Appendix 7) Attachment Press Release Q1 2023 Source: West Corporation Apr 11, 2023: Banco Santander Press Release: Nirsevimab: Sanofi, AstraZeneca and Sobi simplify contractual agreements Nirsevimab: Sanofi, AstraZeneca and Sobi simplify contractual agreements Modification of existing collaboration agreement with AstraZeneca gives Sanofi full commercial control of nirsevimab and enhanced agility in the U.S.Existing collaboration agreement with AstraZeneca remains in place for nirsevimab activities ex-U.S. Paris, April 11, 2023. Sanofi has simplified its contractual arrangements relating to the development and commercialization of Beyfortus (nirsevimab) in the United States (U.S.). Under the new and updated arrangements, Sobi will terminate its participation agreement with AstraZeneca, and Sanofi and AstraZeneca will update the Collaboration Agreement so that Sanofi has full commercial control of nirsevimab in the U.S. Sanofi has simultaneously entered into a direct royalty agreement with Sobi to share a portion of U.S. net sales from nirsevimab. With respect to territories outside the U.S., the existing Collaboration Agreement between AstraZeneca and Sanofi continues to govern that relationship. The new and updated contractual agreements do not impact nirsevimab registration and launch in the U.S., where all parties remain committed to making Beyfortus available for all infants in time for the 2023/24 RSV season. About BeyfortusBeyfortus (nirsevimab), an investigational long-acting antibody designed to protect all infants against RSV infections from birth through their first RSV viral season with a single dose, is being co-developed by Sanofi and AstraZeneca. Beyfortus was developed to provide direct antibody protection to newborns and infants and protect them against lower respiratory tract infections caused by RSV. Monoclonal antibodies do not require activation of the immune system to confer direct and rapid protection against infection. Beyfortus has received marketing authorization in the European Union for the prevention of lower respiratory tract disease caused by RSV in neonates and infants from birth during their first RSV season. In March 2017, AstraZeneca and Sanofi announced an agreement for the development and commercialization of Beyfortus. Under the agreement, AstraZeneca leads all development and manufacturing activities, while Sanofi is responsible for marketing activities and revenue recognition. Under the terms of the global agreement, Sanofi has made an upfront payment of 120 million, a milestone payment of 30 million and a regulatory payment of 25 million. Sanofi shall pay up to 440 million, subject to the achievement of a certain number of regulatory and sales objectives. Both companies share costs and benefits related to the Alliance in certain territories. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Media RelationsSandrine Guendoul|+ 33 6 25 09 14 25 |sandrine.guendoul@sanofi.comEvan Berland | +1 215 432 0234 | evan.berland@sanofi.comVictor Rouault|+ 33 6 70 93 71 40 |victor.rouault@sanofi.com Investor RelationsEva Schaefer-Jansen|+ 33 7 86 80 56 39 |eva.schaefer-jansen@sanofi.comArnaud Delepine|+ 33 6 73 69 36 93 | arnaud.delepine@sanofi.comCorentine Driancourt|+ 33 6 40 56 92 21 | corentine.driancourt@sanofi.comFelix Lauscher|+ 1908612 7239 | felix.lauscher@sanofi.comTarik Elgoutni| + 1 617 710 3587 | tarik.elgoutni@sanofi.comNathalie Pham|+ 33 7 85 93 30 17 | nathalie.pham@sanofi.com Sanofi Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words expects, anticipates, believes, intends, estimates, plans and similar expressions. Although Sanofis management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofis ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under Risk Factors and Cautionary Statement Regarding Forward-Looking Statements in Sanofis annual report on Form 20-F for the year ended December 31, 2022. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. Attachment Press_Release Source: West Corporation Apr 04, 2023: Banco Santander Press Release: Two fitusiran Phase 3 studies published in The Lancet and The Lancet Haematology highlight potential to address unmet needs across all types of hemophilia Two fitusiran Phase 3 studies published in The Lancet and The Lancet Haematology highlight potential to address unmet needs across all types of hemophilia Both Phase 3 studies achieved their primary and secondary endpoints; fitusiran prophylaxis demonstrated significant and clinically meaningful improvements in bleed protection across all hemophilia populations, presented at ASH 2021 Paris April 4, 2023 Two studies, published in The Lancet and The Lancet Haematology, evaluating the efficacy and safety of fitusiran, an investigational siRNA therapy for the prophylactic treatment of adults and adolescents with hemophilia A or B, reinforce the potential of this investigational therapy to transform the current standard of care and address unmet needs for all types of hemophilia, regardless of inhibitor status. Hemophilia A and B are rare congenital lifelong bleeding disorders in which the ability of a persons blood to clot is impaired, leading to excessive bleeds and spontaneous bleeds into joints that can result in joint damage and chronic pain, and significantly impact quality of life. Fitusiran has the potential to provide prophylaxis for all types of hemophilia, regardless of inhibitor status, with as few as six subcutaneous injections per year. Dietmar Berger, M.D., Ph.D.Head of Global R&D ad interim and Chief Medical Officer at Sanofi Sanofi is committed to advancing the standard of care for all people with hemophilia through innovative science, providing consistent bleed protection while reducing treatment burden. We are entering a new era in hemophilia where, for the first time, people can choose therapies that meet their personal needs. These published data validate our science and add to a growing body of evidence supporting fitusirans potential to transform the treatment landscape. We look forward to sharing additional data on fitusiran later this year. Both Phase 3 studies compared once-monthly subcutaneous fitusiran prophylaxis (80mg) with on-demand/episodic use of clotting factor concentrates in the ATLAS-A/B study, and on-demand/episodic use of bypassing agents in the ATLAS-INH study. Across both clinical studies, prophylactic treatment with fitusiran reduced annualized bleeding rates by 90% (95% CI [84.1%; 93.6%], P <0.0001) compared to the control arms, showing a statistically significant and clinically meaningful improvement in bleeding episodes when compared to on-demand treatments; and showed improvement in quality of life. In the study ATLAS-INH study published by The Lancet, 66% of participants with inhibitors (25 out of 38) receiving fitusiran 80mg monthly experienced zero bleeding episodes compared to 5% (1 out of 19) receiving an on-demand bypassing agent after nine months of treatment. The ATLAS A/B study published in The Lancet Haematology showed 51% of participants without inhibitors (40 out of 79) who received fitusiran 80mg monthly prophylaxis experienced zero bleeds compared to 5% (2 out of 40) in the comparator group, receiving on-demand clotting factor concentrates. Sanofi is currently investigating the efficacy and safety of fitusiran under a revised regimen which includes lower doses and less frequent dosing (as few as six subcutaneous injections per year), maintaining an antithrombin target range of 15-35% in all ongoing studies. ATLAS-AB Phase 3 StudyATLAS-A/B is a Phase 3 randomized, open-label study investigating the efficacy and safety of fitusiran in males 12 years with severe hemophilia A or B without inhibitors who had previously been treated with on-demand clotting factor concentrates. Study participants (n=120) were randomized 2:1 to receive either once-monthly 80mg subcutaneous fitusiran prophylaxis or on-demand clotting factor concentrates. The primary endpoint is annualized bleeding rate. ATLAS-INH Phase 3 StudyThe ATLAS-INH study is a randomized, open-label Phase 3 study designed to evaluate the safety and efficacy of fitusiran in males 12 years with severe hemophilia A or B with inhibitors to factor VIII or IX. Study participants (n=57) receiving on-demand treatment with bypassing agents (BPA) were randomized in a 2:1 ratio to receive once-monthly 80mg subcutaneous fitusiran prophylaxis or continue with on-demand BPA. The primary endpoint is annualized bleeding rate. About fitusiranFitusiran is an investigational, subcutaneously administered small interference RNA therapeutic in development for the prophylactic treatment of people with hemophilia A or B, with or without inhibitors. Fitusiran is designed to lower antithrombin, a protein that inhibits blood clotting, with the goal of promoting thrombin generation to rebalance hemostasis and prevent bleeds. Fitusiran utilizes Alnylam Pharmaceutical Inc.s ESC-GalNAc conjugate technology, which enables subcutaneous dosing with increased potency and durability. Fitusiran is currently under clinical investigation and has not been evaluated by any regulatory authority. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY. Media RelationsSally Bain|+ 1 781 264 1091 |sally.bain@sanofi.comSandrine Guendoul|+ 33 6 25 09 14 25 |sandrine.guendoul@sanofi.comNicolas Obrist|+ 33 6 77 21 27 55 |nicolas.obrist@sanofi.com Investor RelationsEva Schaefer-Jansen|+ 33 7 86 80 56 39 |eva.schaefer-jansen@sanofi.comArnaud Delepine|+ 33 6 73 69 36 93 | arnaud.delepine@sanofi.comCorentine Driancourt|+ 33 6 40 56 92 21 | corentine.driancourt@sanofi.comFelix Lauscher|+ 1908612 7239 | felix.lauscher@sanofi.comTarik Elgoutni| + 1 617 710 3587 | tarik.elgoutni@sanofi.comNathalie Pham|+ 33 7 85 93 30 17 | nathalie.pham@sanofi.com Sanofi Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words expects, anticipates, believes, intends, estimates, plans and similar expressions. Although Sanofis management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofis ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under Risk Factors and Cautionary Statement Regarding Forward-Looking Statements in Sanofis annual report on Form 20-F for the year ended December 31, 2022. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. Attachment Source: West Corporation Mar 30, 2023: Banco Santander Press Release: Availability of the Q1 2023 Memorandum for modelling purposes Availability of the Q1 2023 Memorandum for modelling purposes Paris, France March 30, 2023 - Sanofi announced today that its Q1 2023 Memorandum for modelling purposes is available on the "Investors" page of the company's website: https://www.sanofi.com/en/investors/financial-results-and-events/financial-results/Q1-results-2023 As for each quarter, Sanofi prepared this document to assist in the financial modelling of the Group's quarterly results. This document includes a reminder on various non-comparable items and exclusivity losses as well as the foreign currency impact and share count. Sanofi's first-quarter 2023 results will be published on April 27, 2023. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Media RelationsSandrine Guendoul | + 33 6 25 09 14 25 | sandrine.guendoul@sanofi.comSally Bain | + 1 617 834 6026 | sally.bain@sanofi.comNicolas Obrist | + 33 06 77 21 27 55 | nicolas.obrist@sanofi.comVictor Rouault | + 33 06 70 93 71 40 | victor.rouault@sanofi.com Investor RelationsEva Schaefer-Jansen | + 33 7 86 80 56 39 | eva.schaefer-jansen@sanofi.com Arnaud Delepine | + 33 06 73 69 36 93 | arnaud.delepine@sanofi.comCorentine Driancourt | + 33 06 40 56 92 | corentine.driancourt@sanofi.com Felix Lauscher | + 1 908 612 7239 | felix.lauscher@sanofi.com Tarik Elgoutni | + 1 617 710 3587 | tarik.elgoutni@sanofi.comNathalie Pham | + 33 07 85 93 30 17 | nathalie.pham@sanofi.com Sanofi Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words expects, anticipates, believes, intends, estimates, plans and similar expressions. Although Sanofis management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofis ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under Risk Factors and Cautionary Statement Regarding Forward-Looking Statements in Sanofis annual report on Form 20-F for the year ended December 31, 2022. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. Attachment Source: West Corporation Mar 23, 2023: Banco Santander Press Release: Dupixent demonstrates potential to become first biologic to treat COPD by showing significant reduction in exacerbations in pivotal trial Dupixent demonstrates potential to become first biologic to treat COPD by showing significant reduction in exacerbations in pivotal trial First and only biologic to demonstrate clinically meaningful and statistically significant reduction (30%) in exacerbations compared to placeboFirst and only biologic to show rapid and significant improvement in lung function (160 mL in FEV1) compared to placebo (77 mL in FEV1) First and only biologic to demonstrate significant improvements in quality of life and respiratory symptomsCOPD is the third leading cause of death worldwide with no new treatment approaches approved in more than a decade; trial enrolled patients with moderate to severe disease and evidence of type 2 inflammation (i.e., blood eosinophils 300 cells/L)COPD is the seventh disease in which Dupixent has shown positive pivotal results, confirming the key role of IL-4 and IL-13 in these type 2 inflammatory diseases Paris and Tarrytown, N.Y. March 23, 2023. The primary and all key secondary endpoints were met in a Phase 3 trial evaluating the investigational use of Dupixent (dupilumab) compared to placebo in adults currently on maximal standard-of-care inhaled therapy (triple therapy) with uncontrolled chronic obstructive pulmonary disease (COPD) and evidence of type 2 inflammation. Dupixent is the first and only biologic to demonstrate a clinically meaningful and highly significant reduction (30%) in moderate or severe acute exacerbations of COPD (rapid and acute worsening of respiratory symptoms), while also demonstrating significant improvements in lung function, quality of life and COPD respiratory symptoms. Dietmar Berger, M.D., Ph.D.Head of Global R&D ad interim and Chief Medical Officer at Sanofi "Change cannot come quick enough for people living with uncontrolled COPD but, unfortunately, many investigational treatments have failed to demonstrate significant clinical outcomes leaving these vulnerable patients with limited treatment options. We took a bold approach with our direct to Phase 3 program, shaving years off standard clinical development timelines. We are excited to share these unprecedented and potentially paradigm-shifting clinical results, which may give new hope to patients, caregivers and physicians. COPD is a life-threatening respiratory disease that damages the lungs and causes progressive lung function decline. Symptoms include persistent cough and breathlessness that may not only impair the ability to perform routine daily activities, but can also lead to anxiety, depression and sleep disturbances. COPD is also associated with a significant health and economic burden due to recurrent acute exacerbations that require systemic corticosteroid treatment and/or lead to hospitalization or even death. Smoking is a key risk factor for COPD, but even individuals who quit smoking can still develop the disease. In the U.S. alone, approximately 300,000 people live with uncontrolled COPD with type 2 inflammation. George D. Yancopoulos, M.D., Ph.D.President and Chief Scientific Officer at RegeneronCOPD is an urgent global health concern and a notoriously difficult-to-treat disease due to its heterogeneity, with no novel treatments approved in more than a decade. In this landmark Phase 3 trial, patients with uncontrolled COPD achieved clinical outcomes with Dupixent at a magnitude never before seen with a biologic. These results also validate the role type 2 inflammation plays in driving COPD in these patients, advancing the scientific communitys understanding of the underlying biology of this disease. We look forward to discussing these exciting results with regulatory authorities. In the BOREAS Phase 3 trial (the first of two Phase 3 trials), 939 adults who were current or former smokers aged 40 to 80 years were randomized to receive Dupixent (n=468) or placebo (n=471), added to maximal standard-of-care inhaled therapy. Patients receiving Dupixent experienced: 30% reduction in moderate or severe acute COPD exacerbations over 52 weeks (p=0.0005), the primary endpoint. Improved lung function from baseline by 160 mL at 12 weeks compared to 77 mL for placebo (p<0.0001), with the benefit versus placebo sustained through week 52 (p=0.0003), both of which were key secondary endpoints. Dupixent met all endpoints tested in the hierarchy, including improvement in patient-reported health-related quality of life as measured by St. Georges Respiratory Questionaire (SGRQ) and reduction in the severity of respiratory symptoms of COPD as measured by Evaluation Respiratory Symptoms: COPD (E-RS: COPD) Scale. The safety results were generally consistent with the known safety profile of Dupixent in its approved indications. Overall rates of adverse events (AE) were 77% for Dupixent and 76% for placebo. AEs more commonly observed with Dupixent compared to placebo included headache (8.1% Dupixent, 6.8% placebo), diarrhea (5.3% Dupixent, 3.6% placebo) and back pain (5.1% Dupixent, 3.4% placebo). AEs more commonly observed with placebo compared to Dupixent included upper respiratory tract infection (9.8% placebo, 7.9% Dupixent), hypertension (6.0% placebo, 3.6% Dupixent) and COVID-19 (5.7% placebo, 4.1% Dupixent). AEs leading to deaths were balanced between the two arms (1.7% placebo, 1.5% Dupixent). Detailed efficacy and safety results from this trial will be presented in a future scientific forum. The broader Sanofi and Regeneron COPD clinical research program includes Phase 3 trials with itepekimab, a fully human monoclonal antibody that binds to and inhibits interleukin-33 (IL-33). Itepekimab received Fast Track Designation from the U.S. Food and Drug Administration in January 2023 for the treatment of COPD in patients who do not currently smoke. Data from this pivotal program is expected in 2025. The safety and efficacy of Dupixent and itepekimab in COPD have not been fully evaluated by any regulatory authority. About the Dupixent COPD Phase 3 Trial ProgramBOREAS is one of two pivotal trials in the Dupixent COPD program. The randomized, Phase 3, double-blind, placebo-controlled trial evaluated the efficacy and safety of Dupixent in 939 adults who were current or former smokers aged 40 to 80 years with moderate-to-severe COPD. All patients in the trial had evidence of type 2 inflammation, as measured by blood eosinophils 300 cells/L. During the 52-week treatment period, patients received Dupixent or placebo every two weeks, added to triple therapy of inhaled corticosteroids (ICS), long-acting beta agonists, and long-acting muscarinic antagonists. Double maintenance therapy was allowed if ICS was contraindicated. The primary endpoint evaluated the annualized rate of acute moderate or severe COPD exacerbations. Moderate exacerbations were defined as those requiring systemic steroids and/or antibiotics. Severe exacerbations were defined as those: requiring hospitalization; more than a day of observation in an emergency department or urgent care facility; or resulting in death. Key secondary endpoints included change from baseline in lung function (assessed by pre-bronchodilator FEV1) at 12 and 52 weeks; change from baseline at week 52 in SGRQ total score compared to placebo; proportion of patients with SGRQ improvement 4 points at week 52; and the change from baseline at 52 weeks in the ERS: COPD Scale symptom scoreThe second, replicate Phase 3 trial of Dupixent in COPD (NOTUS) is ongoing with data expected in 2024. About Sanofi and Regenerons COPDClinical Research ProgramSanofi and Regeneron are motivated to transform the treatment paradigm of COPD by examining the role different types of inflammation play in the disease progression through the investigation of two potentially first-in-class biologics, Dupixent and itepekimab. Dupixent inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and the program focuses on a specific population of people with evidence of type 2 inflammation. Itepekimab is a fully human monoclonal antibody that binds to and inhibits interleukin-33 (IL-33), an initiator and amplifier of broad inflammation in COPD. Across both programs, four Phase 3 trials are ongoing and designed to inform next-generation treatments for people with COPD whom might not have other options. About DupixentDupixent is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not an immunosuppressant. The Dupixent development program has shown significant clinical benefit and a decrease in type 2 inflammation in Phase 3 trials, establishing that IL-4 and IL-13 are key and central drivers of the type 2 inflammation that plays a major role in multiple related and often co-morbid diseases. These diseases include approved indications for Dupixent, such as atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), prurigo nodularis and eosinophilic esophagitis (EoE). Dupixent has received regulatory approvals in one or more countries around the world for use in certain patients with atopic dermatitis, asthma, CRSwNP, EoE or prurigo nodularis in different age populations. Dupixent is currently approved for one or more of these indications in more than 60 countries, including in Europe, the U.S. and Japan. More than 600,000 patients are being treated with Dupixent globally. Dupilumab Development ProgramDupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement. To date, dupilumab has been studied across more than 60 clinical trials involving more than 10,000 patients with various chronic diseases driven in part by type 2 inflammation. In addition to the currently approved indications, Sanofi and Regeneron are studying dupilumab in a broad range of diseases driven by type 2 inflammation or other allergic processes in Phase 3 trials, including pediatric EoE, hand and foot atopic dermatitis, chronic inducible urticaria-cold, chronic spontaneous urticaria, chronic pruritus of unknown origin, COPD with evidence of type 2 inflammation, chronic rhinosinusitis without nasal polyposis, allergic fungal rhinosinusitis, allergic bronchopulmonary aspergillosis and bullous pemphigoid. These potential uses of dupilumab are currently under clinical investigation, and the safety and efficacy in these conditions have not been fully evaluated by any regulatory authority. ...About RegeneronRegeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led for 35 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, hematologic conditions, infectious diseases and rare diseases.Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite technologies, such as VelocImmune, which uses unique genetically humanized mice to produce optimized fully human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.For more information, please visit www.Regeneron.com or follow @Regeneron on Twitter. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY. Media RelationsSandrine Guendoul|+ 33 6 25 09 14 25 |sandrine.guendoul@sanofi.comSally Bain|+ 1 617 834 6026 |sally.bain@sanofi.comKate Conway|+ 1508 364 4931 |kate.conway@sanofi.comNicolas Obrist|+ 33 6 77 21 27 55 |nicolas.obrist@sanofi.comVictor Rouault|+ 33 6 70 93 71 40 |victor.rouault@sanofi.comChrystel Baude|+ 33 6 70 98 70 59 |chrystel.baude@sanofi.com Investor RelationsEva Schaefer-Jansen|+ 33 7 86 80 56 39 |eva.schaefer-jansen@sanofi.comArnaud Delepine|+ 33 6 73 69 36 93 | arnaud.delepine@sanofi.comCorentine Driancourt|+ 33 6 40 56 92 21 | corentine.driancourt@sanofi.comFelix Lauscher|+ 1908612 7239 | felix.lauscher@sanofi.comTarik Elgoutni | + 1 617 710 3587 | tarik.elgoutni@sanofi.comNathalie Pham|+ 33 7 85 93 30 17 | nathalie.pham@sanofi.com Regeneron Media RelationsSharon Chen | +1 914-847-1546 | sharon.chen@regeneron.com Regeneron Investor RelationsVesna Tosic | + 914 847 5443 | vesna.tosic@regeneron.com Sanofi Disclaimers or Forward-Looking Statements This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements are generally identified by the words expects, anticipates, believes, intends, estimates, plans and similar expressions. Although Sanofis management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under Risk Factors and Cautionary Statement Regarding Forward-Looking Statements in Sanofis annual report on Form 20-F for the year ended December 31, 2022. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. Regeneron Forward-Looking Statements and Use of Digital Media This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. (Regeneron or the Company), and actual events or results may differ materially from these forward-looking statements. Words such as anticipate, expect, intend, plan, believe, seek, estimate, variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the impact of SARS-CoV-2 (the virus that has caused the COVID-19 pandemic) on Regenerons business and its employees, collaborators, and suppliers and other third parties on which Regeneron relies, Regenerons and its collaborators ability to continue to conduct research and clinical programs, Regenerons ability to manage its supply chain, net product sales of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, Regenerons Products), and the global economy; the nature, timing, and possible success and therapeutic applications of Regenerons Products and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, Regenerons Product Candidates) and research and clinical programs now underway or planned, including without limitation Dupixent (dupilumab) in patients with uncontrolled chronic obstructive pulmonary disease (COPD) and evidence of type 2 inflammation and itepekimab (a fully human monoclonal antibody that binds to and inhibits interleukin-33) in patients with COPD as discussed in this press release; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regenerons Product Candidates and new indications for Regenerons Products, such as Dupixent for the treatment of COPD as discussed in this press release as well as for the treatment of pediatric eosinophilic esophagitis, chronic inducible urticaria-cold, chronic spontaneous urticaria, chronic pruritus of unknown origin, chronic rhinosinusitis without nasal polyposis, allergic fungal rhinosinusitis, allergic bronchopulmonary aspergillosis, bullous pemphigoid, and other potential indications; uncertainty of the utilization, market acceptance, and commercial success of Regenerons Products and Regenerons Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary), including the studies discussed or referenced in this press release, on any of the foregoing or any potential regulatory approval of Regenerons Products (such as Dupixent for the treatment of COPD) and Regenerons Product Candidates (such as itepekimab); the ability of Regenerons collaborators, licensees, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regenerons Products and Regenerons Product Candidates; the ability of Regeneron to manage supply chains for multiple products and product candidates; safety issues resulting from the administration of Regenerons Products (such as Dupixent) and Regenerons Product Candidates (such as itepekimab) in patients, including serious complications or side effects in connection with the use of Regenerons Products and Regenerons Product Candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict Regenerons ability to continue to develop or commercialize Regenerons Products and Regenerons Product Candidates, including without limitation Dupixent; ongoing regulatory obligations and oversight impacting Regenerons Products, research and clinical programs, and business, including those relating to patient privacy; the availability and extent of reimbursement of Regenerons Products from third-party payers, including private payer healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payers and new policies and procedures adopted by such payers; competing drugs and product candidates that may be superior to, or more cost effective than, Regenerons Products and Regenerons Product Candidates; the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators or licensees may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license, collaboration, or supply agreement, including Regenerons agreements with Sanofi and Bayer (or their respective affiliated companies, as applicable) to be cancelled or terminated; and risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA (aflibercept) Injection, Praluent (alirocumab), and REGEN-COV (casirivimab and imdevimab)), other litigation and other proceedings and government investigations relating to the Company and/or its operations, the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regenerons business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regenerons filings with the U.S. Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2022. Any forward-looking statements are made based on managements current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise. Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regenerons media and investor relations website (http://newsroom.regeneron.com) and its Twitter feed (http://twitter.com/regeneron). Attachment Source: West Corporation Mar 21, 2023: Banco Santander Press Release: Dupixent (dupilumab) approved by European Commission as first and only targeted medicine for children as young as six months old with severe atopic dermatitis Dupixent (dupilumab) approved by European Commission as first and only targeted medicine for children as young as six months old with severe atopic dermatitis Approximately seven times as many patients aged 6 months to 5 years with severe atopic dermatitis treated with Dupixent experienced clear or almost clear skin and reduced overall disease severity compared to placeboPatients treated with Dupixent achieved rapid itch reduction as early as three weeks after start of therapy, with significant improvements at 16 weeks sustained through one yearDupixent is now a treatment option for the approximately 80,000 infants and young children living with uncontrolled severe atopic dermatitis in Europe Milestone marks third Dupixent European Commission approval in the past four months Paris and Tarrytown, N.Y. March 21, 2023. The European Commission (EC) has approved Dupixent(dupilumab) in the European Union (EU) to treat severe atopic dermatitis in children aged 6 months to 5 years old who are candidates for systemic therapy. With this approval, Dupixent is the first and only targeted medicine indicated to treat these young children in Europe and the U.S. Korey Capozza, MPH Founder and Executive Director of Global Parents for Eczema Research (GPER)Watching an infant or young child grapple with the debilitating and wide-reaching impacts of severe atopic dermatitis is heartbreaking. Ive personally witnessed how this chronic skin disease can disrupt the lives of entire families when left uncontrolled. Intervening with effective treatments during infancy and early childhood can help manage the challenging impact this disease has on children and their families during such formative years. Atopic dermatitis is a chronic type 2 inflammatory skin disease. Between 85% and 90% of patients first develop symptoms before 5 years of age, which can often continue through adulthood. Symptoms include intense, persistent itch and skin lesions that cover much of the body, resulting in skin dryness, cracking, pain, redness or darkening, crusting and oozing, which can increase the risk of skin infection. Severe atopic dermatitis may also significantly impact the quality of life of young children and their caregivers. Treatment options in this age group are primarily topical corticosteroids (TCS), which can be associated with safety risks and may impair growth when used long-term. Naimish Patel, M.D.HeadofGlobal Development, Immunology and Inflammation atSanofiA vast majority of people with atopic dermatitis begin to develop symptoms during their earliest, most vulnerable years, and these symptoms can often continue through the rest of their lives. With this latest approval, Dupixent is the first-ever biologic medicine for people living with atopic dermatitis from infancy to adulthood. Given its well-established safety and efficacy profile, Dupixent has the potential to transform the landscape for people of all ages living with atopic dermatitis. We remain committed to exploring Dupixent for the treatment of other chronic inflammatory skin diseases. George D. Yancopoulos, M.D., Ph.D.President and Chief Scientific Officer at RegeneronNo infant or child should have to spend their earliest days suffering with the intense and unrelenting itch and skin pain of atopic dermatitis. Too often the parents and caregivers of children with severe atopic dermatitis are left desperate for new treatments to manage this chronic disease. In the pivotal trial, Dupixent reduced itch and skin pain, and improved health-related quality of life and sleep quality. Dupixent is currently being used to treat more than 600,000 patients around the word across approved indications. This latest EU approval brings the proven efficacy, and importantly, the long-term safety profile of Dupixent to this particularly vulnerable population. The approval is based on data from a Phase 3 trial evaluating Dupixent every four weeks (200 mg or 300 mg based on body weight) plus low-potency TCS or TCS alone (placebo) in 162 children aged 6 months to 5 years with moderate-to-severe atopic dermatitis. At 16 weeks, Dupixent improved skin clearance and reduced overall disease severity and itch compared to placebo in the overall enrolled population. In a subset of those with severe atopic dermatitis, patients randomized to Dupixent (n=63) experienced the following compared to placebo (n=62) at 16 weeks: 46% of patients achieved 75% or greater improvement in overall disease severity compared to 7% treated with placebo, a co-primary endpoint.14% of patients achieved clear or almost clear skin compared to 2% treated with placebo, a co-primary endpoint.55% average reduction in overall disease severity from baseline compared to 10% with placebo.42% average reduction in itch from baseline compared to a 1% increase with placebo. Dupixent also improved sleep quality, skin pain and health-related quality of life compared to placebo in both the overall and severe populations. Long-term efficacy data showed the clinical benefit at 16 weeks was sustained through 52 weeks. The most common side effects across indications include injection site reactions, conjunctivitis, conjunctivitis allergic, arthralgia, oral herpes and eosinophilia. The safety results of the 6 months to 5 years old trial were generally consistent with the known safety profile of Dupixent in its approved indications; in the trial, adverse events more commonly observed (5%) with Dupixent compared to placebo included eosinophilia and conjunctivitis. The long-term safety profile through 52 weeks was similar to the safety profile observed at 16 weeks, and consistent with what was observed in older patients with atopic dermatitis. About the Pivotal Dupixent Atopic Dermatitis TrialThe Phase 3 randomized, double-blind, placebo-controlled trial evaluated the efficacy and safety of Dupixent added to standard-of-care low-potency TCS compared to low-potency TCS alone (placebo) in 162 children aged 6 months to 5 years with moderate-to-severe atopic dermatitis. The co-primary endpoints assessed the proportion of patients achieving an Investigator's Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) and 75% improvement in Eczema Area and Severity Index (EASI-75) at week 16. Additional endpoints measured itch (assessed by a caregiver-reported worst scratch/itch numerical rating scale from 0-10), sleep quality (assessed by a caregiver-reported numerical rating scale from 0-10), skin pain (assessed by a caregiver-reported numerical rating scale from 0-10) and health-related quality of life (assessed by the Childrens Dermatology Life Quality Index in patients aged 4 to 5 years and the Infants Dermatitis Quality of Life Index in patients aged 6 months to 3 years, both scales from 0-30). About Dupixent Dupixent is an injection administered under the skin (subcutaneous injection) at different injection sites. In patients aged 6 months to 5 years, Dupixent is administered with a pre-filled syringe every four weeks based on weight (200 mg for children 5 to <15 kg and 300 mg for children 15 to <30 kg). Dupixent is intended for use under the guidance of a healthcare professional and can be given in a clinic or at home by self-administration after training by a healthcare professional. In children younger than 12 years of age, Dupixent should be administered by a caregiver if given at home. Dupixent does not require initial lab testing or ongoing lab monitoring. Dupixent is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not an immunosuppressant. The Dupixent development program has shown significant clinical benefit and a decrease in type 2 inflammation in Phase 3 trials, establishing that IL-4 and IL-13 are key and central drivers of the type 2 inflammation that plays a major role in multiple related and often co-morbid diseases. These diseases include approved indications for Dupixent, such as atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), eosinophilic esophagitis (EoE) and prurigo nodularis. Dupixent has received regulatory approvals in one or more countries around the world for use in certain patients with atopic dermatitis, asthma, CRSwNP, EoE or prurigo nodularis in different age populations. Dupixent is currently approved for one or more of these indications in more than 60 countries, including in Europe, the U.S. and Japan. More than 600,000 patients are being treated with Dupixent globally. Dupilumab Development Program Dupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement. To date, dupilumab has been studied across more than 60 clinical trials involving more than 10,000 patients with various chronic diseases driven in part by type 2 inflammation. In addition to the currently approved indications, Sanofi and Regeneron are studying dupilumab in a broad range of diseases driven by type 2 inflammation or other allergic processes in Phase 3 trials, including pediatric EoE, chronic inducible urticaria-cold, chronic spontaneous urticaria, chronic pruritus of unknown origin, chronic obstructive pulmonary disease with evidence of type 2 inflammation, chronic rhinosinusitis without nasal polyposis, allergic fungal rhinosinusitis, allergic bronchopulmonary aspergillosis and bullous pemphigoid. These potential uses of dupilumab are currently under clinical investigation, and the safety and efficacy in these conditions have not been fully evaluated by any regulatory authority. About Regeneron Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led for 35 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, hematologic conditions, infectious diseases and rare diseases. Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite technologies, such as VelocImmune, which uses unique genetically humanized mice to produce optimized fully human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world. For more information, please visit www.Regeneron.com or follow @Regeneron on Twitter. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY. Media RelationsSally Bain|+ 1 617 834 6026 |sally.bain@sanofi.com Investor RelationsEva Schaefer-Jansen|+ 33 7 86 80 56 39 |eva.schaefer-jansen@sanofi.comArnaud Delepine|+ 33 6 73 69 36 93 | arnaud.delepine@sanofi.comCorentine Driancourt|+ 33 6 40 56 92 21 | corentine.driancourt@sanofi.comFelix Lauscher|+ 1908612 7239 | felix.lauscher@sanofi.comTarik Elgoutni| + 1 617 710 3587 | tarik.elgoutni@sanofi.comNathalie Pham|+ 33 7 85 93 30 17 | nathalie.pham@sanofi.com Regeneron Media RelationsHannah Kwagh | +1 914-847-6314 | hannnah.kwagh@regeneron.com Regeneron Investor RelationsVesna Tosic | + 914 847 5443 | vesna.tosic@regeneron.com Sanofi Forward-Looking Statements This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements are generally identified by the words expects, anticipates, believes, intends, estimates, plans and similar expressions. Although Sanofis management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under Risk Factors and Cautionary Statement Regarding Forward-Looking Statements in Sanofis annual report on Form 20-F for the year ended December 31, 2022. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. Regeneron Forward-Looking Statements and Use of Digital Media This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance ofRegeneron Pharmaceuticals, Inc.(Regeneron or the Company), and actual events or results may differ materially from these forward-looking statements. Words such as anticipate, expect, intend, plan, believe, seek, estimate, variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the impact of SARS-CoV-2 (the virus that has caused the COVID-19 pandemic) on Regenerons business and its employees, collaborators, and suppliers and other third parties on which Regeneron relies, Regenerons and its collaborators ability to continue to conduct research and clinical programs, Regenerons ability to manage its supply chain, net product sales of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, Regenerons Products), and the global economy; the nature, timing, and possible success and therapeutic applications of Regenerons Products and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, Regenerons Product Candidates) and research and clinical programs now underway or planned, including without limitation Dupixent (dupilumab) for the treatment of severe atopic dermatitis in children 6 months to 5 years old; uncertainty of the utilization, market acceptance, and commercial success of Regenerons Products and Regenerons Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary), including the studies discussed or referenced in this press release, on any of the foregoing; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regenerons Product Candidates and new indications for Regenerons Products, such asDupixent for the treatment of pediatric eosinophilic esophagitis, hand and foot atopic dermatitis, chronic inducible urticaria-cold, chronic spontaneous urticaria, chronic pruritus of unknown origin, chronic obstructive pulmonary disease with evidence of type 2 inflammation, chronic rhinosinusitis without nasal polyposis, allergic fungal rhinosinusitis, allergic bronchopulmonary aspergillosis, bullous pemphigoid, and other potential indications; the ability of Regenerons collaborators, licensees, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regenerons Products and Regenerons Product Candidates; the ability of Regeneron to manage supply chains for multiple products and product candidates; safety issues resulting from the administration of Regenerons Products (such as Dupixent) and Regenerons Product Candidates in patients, including serious complications or side effects in connection with the use of Regenerons Products and Regenerons Product Candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict Regenerons ability to continue to develop or commercialize Regenerons Products and Regenerons Product Candidates, including without limitation Dupixent; ongoing regulatory obligations and oversight impacting Regenerons Products, research and clinical programs, and business, including those relating to patient privacy; the availability and extent of reimbursement of Regenerons Products from third-party payers, including private payer healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payers and new policies and procedures adopted by such payers; competing drugs and product candidates that may be superior to, or more cost effective than, Regenerons Products and Regenerons Product Candidates; the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators or licensees may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license, collaboration, or supply agreement, including Regenerons agreements with Sanofi and Bayer (or their respective affiliated companies, as applicable) to be cancelled or terminated; and risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA(aflibercept) Injection, Praluent(alirocumab), and REGEN-COV (casirivimab and imdevimab)), other litigation and other proceedings and government investigations relating to the Company and/or its operations, the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regenerons business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regenerons filings with theU.S. Securities and Exchange Commission, including its Form 10-K for the year endedDecember 31, 2022. Any forward-looking statements are made based on managements current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise.Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regenerons media and investor relations website (http://newsroom.regeneron.com) and its Twitter feed (http://twitter.com/regeneron). Attachment Source: West Corporation Mar 18, 2023: Banco Santander Press Release: Dupixent (dupilumab) late-breaking data at AAD show significant improvements in signs and symptoms of moderate-to-severe atopic hand and foot dermatitis Dupixent (dupilumab) late-breaking data at AAD show significant improvements in signs and symptoms of moderate-to-severe atopic hand and foot dermatitis More than twice as many patients on Dupixent achieved clear or almost clear skin compared to placebo at 16 weeksNearly four times as many patients on Dupixent saw a clinically meaningful reduction of itch, with improvements seen as early as one week Paris and Tarrytown, N.Y. March 18, 2023. Positive results from the clinical trial assessing Dupixent (dupilumab) in adults and adolescents with uncontrolled moderate-to-severe atopic hand and foot dermatitis were presented today. The trial, the first evaluating a biologic for this difficult-to-treat population, met its primary and key secondary endpoints. The results were featured in a late-breaking session, one of more than 20 Dupixent scientific presentations, at the American Academy of Dermatology (AAD) 2023 Annual Meeting. Eric L. Simpson, M.D.Frances J. Storrs Professor of Medical Dermatology at the Oregon Health and Science University and principal investigator of this trialAtopic hand and foot dermatitis can extensively disrupt the lives of patients, given the intense itch and painful skin lesions it causes on essential body areas. In this trial, Dupixent significantly improved disease signs, symptoms and quality of life measures for this particularly difficult-to-treat subset of atopic dermatitis patients, with itch improvement seen as early as one week after the first dose. While the efficacy and safety profile of Dupixent is well-established for atopic dermatitis more broadly, these positive results are the first demonstrating the impact on specific and heavily used areas of the body. In the trial, patients received Dupixent (n=67) every two weeks (adults 300 mg, adolescents 200 mg or 300 mg based on body weight) or placebo (n=66). At 16 weeks, patients treated with Dupixent experienced the following: 40% achieved clear or almost clear skin on hands and feet compared to 17% with placebo (p0.01), the primary endpoint.52% saw a clinically meaningful reduction in itch on hands and feet compared to 14% with placebo (p<0.0001), the key secondary endpoint.69% average reduction in signs of hand and foot lesions from baseline compared to 31% with placebo (p<0.0001).75% average improvement in hand eczema disease severity from baseline compared to 40% with placebo (p<0.0001).There were significant improvements in measures of hand and foot skin pain, sleep and hand eczema-related quality of life. The trial demonstrated similar safety results to the known safety profile of Dupixent in atopic dermatitis. Overall rates of adverse events (AEs) were 66% for Dupixent and 74% for placebo. AEs more commonly observed with Dupixent (5%) compared to placebo included nasopharyngitis (16% Dupixent, 11% placebo), upper respiratory tract infection (9% Dupixent, 5% placebo), conjunctivitis (6% Dupixent, 2% placebo), herpes viral infections (6% Dupixent, 3% placebo) and increased blood creatine phosphokinase (6% Dupixent, 0% placebo). Additionally, 3% of patients taking Dupixent used at least one rescue medication compared to 21% of patients on placebo. There are 23 Dupixent scientific abstracts being presented across three dermatological diseases with underlying type 2 inflammation at the AAD 2023 Annual Meeting. These include oral presentations on long-term Dupixent use in children as young as 6 months with atopic dermatitis; the impact of Dupixent treatment on health-related quality of life, skin pain and sleep in prurigo nodularis; and the investigational use of Dupixent on signs, symptoms and health-related quality of life in chronic spontaneous urticaria. The potential use of Dupixent in chronic spontaneous urticaria is currently under clinical development, and the safety and efficacy have not been fully evaluated by any regulatory authority. About the Dupixent Trial The Phase 3 double-blind, placebo-controlled trial evaluated the efficacy and safety of Dupixent in 133 adolescents and adults with moderate-to-severe atopic hand and foot dermatitis who had an inadequate response or intolerance to topical corticosteroids. Patients with hand and foot disease predominantly driven by allergic or irritant contact dermatitis were excluded from the trial. The primary endpoint evaluated the proportion of patients with clear or almost clear skin of hand and feet eczema at 16 weeks (measured by a score of 0 or 1 on the Investigator Global Assessment Scale). The key secondary endpoint measured the proportion of patients with improvement in itch on hands and feet from baseline (measured by a 4-point reduction in Peak-Pruritis Numeric Rating Scale [PP-NRS] on a 0-10 scale) at 16 weeks. Lesion sign reduction was assessed by change from baseline in Modified Total Lesion Sign Score (mTLSS; measured by a 0-36 scale), and disease severity was assessed by the change from baseline in Hand Eczema Severity Index (HECSI) score (measured by a 0-360 scale). Symptoms were assessed every one or two weeks during the trial. Additional secondary endpoints included: Skin pain reduction as assessed by the change from baseline in weekly average of daily hand and foot peak pain NRS (measured by a 0-10 scale).Sleep improvement as assessed by change from baseline in weekly average of daily Sleep NRS (measured by a 0-10 scale).Health-related quality of life, assessed by change from baseline in the Quality of Life in Hand Eczema Questionnaire (QoLHEQ) (measured by a 0-117 scale). About Dupixent Dupixent is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not an immunosuppressant. The Dupixent development program has shown significant clinical benefit and a decrease in type 2 inflammation in Phase 3 trials, establishing that IL-4 and IL-13 are key and central drivers of the type 2 inflammation that plays a major role in multiple related and often co-morbid diseases. These diseases include approved indications for Dupixent, such as atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), eosinophilic esophagitis (EoE) and prurigo nodularis. Dupixent has received regulatory approvals in one or more countries around the world for use in certain patients with atopic dermatitis, asthma, CRSwNP, EoE or prurigo nodularis in different age populations. Dupixent is currently approved for one or more of these indications in more than 60 countries, including in the U.S., European Union and Japan. More than 600,000 patients are being treated with Dupixent globally. Dupilumab Development Program Dupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement. To date, dupilumab has been studied across more than 60 clinical trials involving more than 10,000 patients with various chronic diseases driven in part by type 2 inflammation. In addition to the currently approved indications, Sanofi and Regeneron are studying dupilumab in a broad range of diseases driven by type 2 inflammation or other allergic processes in Phase 3 trials, including pediatric EoE, chronic inducible urticaria-cold, chronic spontaneous urticaria, chronic pruritus of unknown origin, chronic obstructive pulmonary disease with evidence of type 2 inflammation, chronic rhinosinusitis without nasal polyposis, allergic fungal rhinosinusitis, allergic bronchopulmonary aspergillosis and bullous pemphigoid. These potential uses of dupilumab are currently under clinical investigation, and the safety and efficacy in these conditions have not been fully evaluated by any regulatory authority. About Regeneron Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led for 35 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, hematologic conditions, infectious diseases and rare diseases. Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite technologies, such as VelocImmune, which uses unique genetically humanized mice to produce optimized fully human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world. For more information, please visit www.Regeneron.com or follow @Regeneron on Twitter. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY. Media RelationsSally Bain|+ 1 617 834 6026 |sally.bain@sanofi.com Investor RelationsEva Schaefer-Jansen|+ 33 7 86 80 56 39 |eva.schaefer-jansen@sanofi.comArnaud Delepine|+ 33 6 73 69 36 93 | arnaud.delepine@sanofi.comCorentine Driancourt|+ 33 6 40 56 92 21 | corentine.driancourt@sanofi.comFelix Lauscher|+ 1908612 7239 | felix.lauscher@sanofi.comTarik Elgoutni| + 1 617 710 3587 | tarik.elgoutni@sanofi.comNathalie Pham|+ 33 7 85 93 30 17 | nathalie.pham@sanofi.com Regeneron Media RelationsHannah Kwagh | +1 914-847-6314 | hannah.kwagh@regeneron.com Regeneron Investor RelationsVesna Tosic | + 914 847 5443 | vesna.tosic@regeneron.com Sanofi Disclaimers or Forward-Looking Statements This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements are generally identified by the words expects, anticipates, believes, intends, estimates, plans and similar expressions. Although Sanofis management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under Risk Factors and Cautionary Statement Regarding Forward-Looking Statements in Sanofis annual report on Form 20-F for the year ended December 31, 2022. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. Regeneron Forward-Looking Statements and Use of Digital Media This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. (Regeneron or the Company), and actual events or results may differ materially from these forward-looking statements. Words such as anticipate, expect, intend, plan, believe, seek, estimate, variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the impact of SARS-CoV-2 (the virus that has caused the COVID-19 pandemic) on Regenerons business and its employees, collaborators, and suppliers and other third parties on which Regeneron relies, Regenerons and its collaborators ability to continue to conduct research and clinical programs, Regenerons ability to manage its supply chain, net product sales of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, Regenerons Products), and the global economy; the nature, timing, and possible success and therapeutic applications of Regenerons Products and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, Regenerons Product Candidates) and research and clinical programs now underway or planned, including without limitation Dupixent; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regenerons Product Candidates and new indications for Regenerons Products, such as Dupixent for the treatment atopic hand and foot dermatitis as discussed in this press release as well as for the treatment of pediatric eosinophilic esophagitis, chronic inducible urticaria-cold, chronic spontaneous urticaria, chronic pruritus of unknown origin, chronic obstructive pulmonary disease with evidence of type 2 inflammation, chronic rhinosinusitis without nasal polyposis, allergic fungal rhinosinusitis, allergic bronchopulmonary aspergillosis, bullous pemphigoid, and other potential indications; uncertainty of the utilization, market acceptance, and commercial success of Regenerons Products and Regenerons Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary), including the studies discussed or referenced in this press release, on any of the foregoing or any potential regulatory approval of Regenerons Products (such as Dupixent) and Regenerons Product Candidates; the ability of Regenerons collaborators, licensees, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regenerons Products and Regenerons Product Candidates; the ability of Regeneron to manage supply chains for multiple products and product candidates; safety issues resulting from the administration of Regenerons Products (such as Dupixent) and Regenerons Product Candidates in patients, including serious complications or side effects in connection with the use of Regenerons Products and Regenerons Product Candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict Regenerons ability to continue to develop or commercialize Regenerons Products and Regenerons Product Candidates, including without limitation Dupixent; ongoing regulatory obligations and oversight impacting Regenerons Products, research and clinical programs, and business, including those relating to patient privacy; the availability and extent of reimbursement of Regenerons Products from third-party payers, including private payer healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payers and new policies and procedures adopted by such payers; competing drugs and product candidates that may be superior to, or more cost effective than, Regenerons Products and Regenerons Product Candidates; the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators or licensees may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license, collaboration, or supply agreement, including Regenerons agreements with Sanofi and Bayer (or their respective affiliated companies, as applicable) to be cancelled or terminated; and risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA (aflibercept) Injection, Praluent (alirocumab), and REGEN-COV (casirivimab and imdevimab)), other litigation and other proceedings and government investigations relating to the Company and/or its operations, the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regenerons business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regenerons filings with the U.S. Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2022. Any forward-looking statements are made based on managements current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise. Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regenerons media and investor relations website (http://newsroom.regeneron.com) and its Twitter feed (http://twitter.com/regeneron). Attachment Source: West Corporation Mar 16, 2023: Banco Santander Press Release: Sanofi cuts U.S. list price of Lantus, its most-prescribed insulin, by 78% and caps out-of-pocket Lantus costs at $35 for all patients with commercial insurance Sanofi cuts U.S. list price of Lantus, its most-prescribed insulin, by 78% and caps out-of-pocket Lantus costs at $35 for all patients with commercial insurance Paris, March 16, 2023. Sanofi announces that it will cut the list price of Lantus (insulin glargine injection) 100 Units/mL, its most widely prescribed insulin in the U.S., by 78 percent. The company also will establish a $35 cap on out-of-pocket costs for Lantus for all patients with commercial insurance, underscoring its longstanding commitment to offer affordable access to medicines. These moves, which go into effect January 1, 2024, will come in addition to decisions taken in June 2022 to lower diabetes medicines costs: the launch of an unbranded Lantus biologic at -60% versus Lantus list price, and a cap on out-of-pocket costs on insulin to $35 for all people without insurance. With all those decisions, now Sanofis suite of savings programs ensures that no patient will pay more than $35 for a monthly supply of Lantus. Finally, Sanofi will also cut the list price of its short-acting Apidra (insulin glulisine injection) 100 Units/mL by 70%. Olivier BogillotHead, U.S. General Medicines, SanofiSanofi believes that no one should struggle to pay for their insulin and we are proud of our continued actions to improve access and affordability for millions of patients for many years. We launched our unbranded biologic for Lantus at 60 percent less than the Lantus list price in June 2022 but, despite this pioneering low-price approach, the health system was unable to take advantage of it due to its inherent structural challenges. We are pleased to see others join our efforts to help patients as we now accelerate the transformation of the U.S. insulin market. Our decision to cut the list price of our lead insulin needs to be coupled with broader change to the overall system to actually drive savings for patients at the pharmacy counter. Sanofi Savings Programs Sanofi will continue to provide different programs to ensure access and affordability to patients depending on their coverage situations and will continue to monitor policy and market changes. Our suite of innovative programs includes: 100% of commercially insured people are eligible for Sanofis copay assistance programs, regardless of income or insurance plan design, which, in 2022 limited out-of-pocket expenses for a majority of participating patients to $15 or less for their diabetes medicines for a 30-day supply.100% of uninsured people are eligible for the Insulins Valyou Savings Program regardless of income level enabling them to buy one or multiple Sanofi insulins at $35 for a 30-day supply. The Soliqua (insulin glargine and lixisenatide) injection 100 Units/mL and 33 mcg/mL cash offer also allows uninsured people to pay as little as $99 per box of pens, for up to two boxes of pens for a 30-day supply. We also provide free medications to qualified low- and middle-income patients the Sanofi Patient Connection program. Some people facing an unexpected financial hardship may be eligible for a one-time, immediate months supply of their Sanofi medicine as they wait for their application to process. Beginning in 2023, Sanofi insulins and Soliqua are included under the Inflation Reduction Act, where covered on Medicare formulary, which provides insulin savings, capping monthly cost at $35 for Seniors who have Medicare Part D. This ensures a predictable, stable co-pay, regardless of phase including the donut hole. Prior to the Inflation Reduction Act, Sanofi voluntarily participated in part of the Centers for Medicare and Medicaid Services (CMS) Senior Savings Model which allowed patients enrolled in participating Part D plans to pay a $35 or less co-pay for each 30-day prescription of a Sanofi insulin throughout the year. Every patient has unique circumstances, and Sanofi has live support specialists who can be reached at (855) 984-6302 to answer individual patients questions and navigate their unique situation to find the best resources and programs to help lower their out-of-pocket costs. Learn more about Sanofis transparent approach to pricing in our 2023 Pricing Principles Report. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Media RelationsEvan Berland | +1 215 432 0234 | evan.berland@sanofi.comSandrine Guendoul|+ 33 6 25 09 14 25 |sandrine.guendoul@sanofi.comVictor Rouault|+ 33 6 70 93 71 40 |victor.rouault@sanofi.com Investor RelationsEva Schaefer-Jansen|+ 33 7 86 80 56 39 |eva.schaefer-jansen@sanofi.comArnaud Delepine|+ 33 6 73 69 36 93 | arnaud.delepine@sanofi.comCorentine Driancourt|+ 33 6 40 56 92 21 | corentine.driancourt@sanofi.comFelix Lauscher|+ 1908612 7239 | felix.lauscher@sanofi.comTarik Elgoutni| + 1 617 710 3587 | tarik.elgoutni@sanofi.comNathalie Pham|+ 33 7 85 93 30 17 | nathalie.pham@sanofi.com Sanofi Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements are generally identified by the words expects, anticipates, believes, intends, estimates, plans and similar expressions. Although Sanofis management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under Risk Factors and Cautionary Statement Regarding Forward-Looking Statements in Sanofis annual report on Form 20-F for the year ended December 31, 2022. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. Attachment Press_Release Source: West Corporation Mar 07, 2023: Banco Santander Press Release: Dupixent (dupilumab) application for treatment of chronic spontaneous urticaria (CSU) in adults and adolescents accepted for FDA review Dupixent (dupilumab) application for treatment of chronic spontaneous urticaria (CSU) in adults and adolescents accepted for FDA review More than 300,000 people in the U.S. suffer from CSU that is inadequately controlled by antihistamines Paris and Tarrytown, N.Y. March 7, 2023. The U.S. Food and Drug Administration (FDA) has accepted, for review, the supplemental Biologics License Application (sBLA) for Dupixent (dupilumab) to treat adults and adolescents aged 12 years and older with chronic spontaneous urticaria (CSU) that is not adequately controlled with the current standard of care, H1 antihistamine treatment. The target action date for the FDA decision is October 22, 2023. CSU is an inflammatory skin condition driven in part by type 2 inflammation, which causes sudden and debilitating hives and swelling on the skin. Swelling, called angioedema, may occur most commonly on the face, hands and feet, but can also affect the throat and upper airways. CSU is typically treated with H1 antihistamines, medicines that target histamine-1 receptors on cells to control symptoms of urticaria. However, the disease remains uncontrolled in up to 50% of patients, who are left with limited alternative treatment options. These individuals continue to experience symptoms, including persistent itch or burning sensations that can be debilitating and significantly impact quality of life. The sBLA is supported by data from two Phase 3 trials (LIBERTY-CUPID Studies A and B), evaluating Dupixent in two different patient populations with uncontrolled CSU. Study A was conducted in CSU patients who were uncontrolled on standard-of-care antihistamines with efficacy and safety data supporting the submission, while Study B was conducted in CSU patients who were uncontrolled on standard-of-care antihistamines and refractory to omalizumab with results providing additional supporting data. The potential use of Dupixent in CSU is currently under clinical development, and the safety and efficacy have not been fully evaluated by any regulatory authority. About the CSU Clinical Trial ProgramThe clinical trial program, known as LIBERTY-CUPID, includes Studies A and B, two Phase 3 randomized, double-blind, placebo-controlled trials evaluating the efficacy and safety of Dupixent in two different patient populations with uncontrolled CSU. Study A evaluated Dupixent as an add-on therapy to standard-of-care H1 antihistamines compared to antihistamines alone in 138 patients with CSU aged 6 years and older who remained symptomatic despite antihistamine use and were not previously treated with omalizumab. Study B evaluated Dupixent in 108 patients with CSU aged 12 to 80 years who remained symptomatic despite standard-of-care treatment and were intolerant or incomplete responders to omalizumab. In addition to CSU, Sanofi and Regeneron are also studying Dupixent in chronic inducible urticaria triggered by cold (LIBERTY-CINDU CUrIADS program) in an ongoing Phase 3 trial. About DupixentDupixent is a fully human monoclonal antibody that inhibits the signaling of the IL-4 and IL-13 pathways and is not an immunosuppressant. The Dupixent development program has shown significant clinical benefit and a decrease in type 2 inflammation in Phase 3 trials, establishing that IL-4 and IL-13 are key and central drivers of the type 2 inflammation that plays a major role in multiple related and often co-morbid diseases. These diseases include approved indications for Dupixent, such as atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), prurigo nodularis and eosinophilic esophagitis (EoE). Dupixent has received regulatory approvals in one or more countries around the world for use in certain patients with atopic dermatitis, asthma, CRSwNP, EoE or prurigo nodularis in different age populations. Dupixent is currently approved for one or more of these indications in more than 60 countries, including in Europe, the U.S. and Japan. More than 500,000 patients have been treated with Dupixent globally. Dupilumab Development ProgramDupilumab is being jointly developed by Regeneron and Sanofi under a global collaboration agreement. To date, dupilumab has been studied across more than 60 clinical trials involving more than 10,000 patients with various chronic diseases driven in part by type 2 inflammation. In addition to the currently approved indications, Sanofi and Regeneron are studying dupilumab in a broad range of diseases driven by type 2 inflammation or other allergic processes in Phase 3 trials, including pediatric EoE, atopic hand and foot dermatitis, chronic inducible urticaria-cold, CSU, chronic pruritus of unknown origin, chronic obstructive pulmonary disease with evidence of type 2 inflammation, chronic rhinosinusitis without nasal polyposis, allergic fungal rhinosinusitis, allergic bronchopulmonary aspergillosis and bullous pemphigoid. These potential uses of dupilumab are currently under clinical investigation, and the safety and efficacy in these conditions have not been fully evaluated by any regulatory authority. About Regeneron Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led for 35 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, hematologic conditions, infectious diseases and rare diseases. Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite technologies, such as VelocImmune, which uses unique genetically humanized mice to produce optimized fully human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world. For more information, please visit www.Regeneron.com or follow @Regeneron on Twitter. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Sanofi Media RelationsSally Bain|+ 1 617 834 6026 |sally.bain@sanofi.com Sanofi Investor RelationsEva Schaefer-Jansen | + 33 7 86 80 56 39 | eva.schaefer-jansen@sanofi.comArnaud Delepine | + 33 06 73 69 36 93 | arnaud.delepine@sanofi.comCorentine Driancourt | + 33 06 40 56 92 | corentine.driancourt@sanofi.comFelix Lauscher | + 1 908 612 7239 | felix.lauscher@sanofi.comTarik Elgoutni | + 1 617 710 3587 | tarik.elgoutni@sanofi.comNathalie Pham | + 33 07 85 93 30 17 | nathalie.pham@sanofi.com Regeneron Media RelationsTammy Allen | + 1 914 306 2698 | tammy.allen@regeneron.com Regeneron Investor RelationsVesna Tosic | + 914 847 5443 | vesna.tosic@regeneron.com Sanofi Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements are generally identified by the words expects, anticipates, believes, intends, estimates, plans and similar expressions. Although Sanofis management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under Risk Factors and Cautionary Statement Regarding Forward-Looking Statements in Sanofis annual report on Form 20-F for the year ended December 31, 2022. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. Regeneron Forward-Looking Statements and Use of Digital Media This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. (Regeneron or the Company), and actual events or results may differ materially from these forward-looking statements. Words such as anticipate, expect, intend, plan, believe, seek, estimate, variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the impact of SARS-CoV-2 (the virus that has caused the COVID-19 pandemic) on Regenerons business and its employees, collaborators, and suppliers and other third parties on which Regeneron relies, Regenerons and its collaborators ability to continue to conduct research and clinical programs, Regenerons ability to manage its supply chain, net product sales of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, Regenerons Products), and the global economy; the nature, timing, and possible success and therapeutic applications of Regenerons Products and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, Regenerons Product Candidates) and research and clinical programs now underway or planned, including without limitation Dupixent (dupilumab) for the treatment of adults and children aged 12 years and older with chronic spontaneous urticaria (CSU); the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regenerons Product Candidates and new indications for Regenerons Products, such as Dupixent for the treatment of CSU (including potential approval by the U.S. Food and Drug Administration based on the supplemental Biologics License Application discussed in this press release), pediatric eosinophilic esophagitis, atopic hand and foot dermatitis, chronic inducible urticaria-cold, chronic pruritus of unknown origin, chronic obstructive pulmonary disease with evidence of type 2 inflammation, chronic rhinosinusitis without nasal polyposis, allergic fungal rhinosinusitis, allergic bronchopulmonary aspergillosis, bullous pemphigoid, and other potential indications; uncertainty of the utilization, market acceptance, and commercial success of Regenerons Products and Regenerons Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary), including the studies discussed or referenced in this press release, on any of the foregoing or any potential regulatory approval of Regeneron's Products (such as Dupixent) and Regeneron's Product Candidates; the ability of Regenerons collaborators, licensees, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regenerons Products and Regenerons Product Candidates; the ability of Regeneron to manage supply chains for multiple products and product candidates; safety issues resulting from the administration of Regenerons Products (such as Dupixent) and Regenerons Product Candidates in patients, including serious complications or side effects in connection with the use of Regenerons Products and Regenerons Product Candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict Regenerons ability to continue to develop or commercialize Regenerons Products and Regenerons Product Candidates, including without limitation Dupixent; ongoing regulatory obligations and oversight impacting Regenerons Products, research and clinical programs, and business, including those relating to patient privacy; the availability and extent of reimbursement of Regenerons Products from third-party payers, including private payer healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payers and new policies and procedures adopted by such payers; competing drugs and product candidates that may be superior to, or more cost effective than, Regenerons Products and Regenerons Product Candidates; the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators or licensees may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license, collaboration, or supply agreement, including Regenerons agreements with Sanofi and Bayer (or their respective affiliated companies, as applicable) to be cancelled or terminated; and risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA (aflibercept) Injection, Praluent (alirocumab), and REGEN-COV (casirivimab and imdevimab), other litigation and other proceedings and government investigations relating to the Company and/or its operations, the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regenerons business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regenerons filings with the U.S. Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2022. Any forward-looking statements are made based on managements current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise. Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regenerons media and investor relations website (http://newsroom.regeneron.com) and its Twitter feed (http://twitter.com/regeneron). Attachment Source: West Corporation Mar 02, 2023: Banco Santander Press Release: Completed XTEND-Kids Phase 3 study strengthens potential of ALTUVIIIOTM to redefine expectations for treatment of children <12 years of age with hemophilia A Completed XTEND-Kids Phase 3 study strengthens potential of ALTUVIIIO to redefine expectations for treatment of children <12 years of age with hemophilia A Paris, March 2, 2023. The XTEND-Kids phase 3 pivotal study evaluating the safety, efficacy and pharmacokinetics of ALTUVIIIO as once-weekly prophylaxis in previously treated patients <12 years of age with severe hemophilia A met its primary endpoint of safety, with no FVIII inhibitors detected in 74 children, with more than 50 children experiencing at least 50 exposure days, nearly a full year of treatment. The completion of XTEND-Kids represents the final milestone needed for regulatory submission in the EU. Karin Knobe, MD, PhDTherapeutic Area Head, Rare Diseases and Rare Blood Disorders, Sanofi At Sanofi, we never settle. We work alongside patients, caregivers, and advocacy organizations to understand the needs of the hemophilia community and pursue first-in-class technologies to meet those needs. We strive for a future where every child with hemophilia can play without fear, travel free from a rigid treatment schedule, and pursue their dreams unencumbered by worry. Hemophilia A is a rare, lifelong condition in which the ability of a persons blood to clot properly is impaired, leading to excessive bleeds and spontaneous bleeds into joints that can result in joint damage and chronic pain, and potentially impact quality of life. The severity of hemophilia is determined by the level of clotting factor activity in a persons blood, and there is a negative correlation between risk of bleeding and factor activity levels. ALUTVIIIO is a first-in-class, high-sustained FVIII therapy approved by the US Food and Drug Administration (FDA) for routine prophylaxis, on-demand treatment and control of bleeding episodes, and perioperative management of bleeding in adults and children in February 2023. Granted Breakthrough Therapy designation by the FDA in May 2022 the first FVIII therapy to receive this designationALTUVIIIO also received Fast Track designation in February 2021 and Orphan Drug designation in 2017. The European Commission granted Orphan Drug designation in June 2019. About XTEND-Kids The XTEND-Kids study (NCT04759131) was an open-label, non-randomized interventional study of the safety, efficacy, and pharmacokinetics of once-weekly ALTUVIIIO in previously treated patients younger than 12 years of age with severe hemophilia A. Patients received once-weekly ALTUVIIIO prophylaxis (50 IU/kg) for 52 weeks which provided high-sustained FVIII levels throughout the weekly dosing interval with a median (IQR) annualized bleeding rate (ABR) of 0.00 (0.00, 1.02) and an estimated mean (95% CI) ABR of 0.89 (0.56 ; 1.42). The primary endpoint was the occurrence of inhibitor development (baseline to 52 weeks). No inhibitors were detected in this study. About ALTUVIIIOALTUVIIIO [Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein-ehtl] is a first-in-class high-sustained factor VIII therapy that is designed to extend protection from bleeds with once-weekly prophylactic dosing for adults and children with hemophilia A. ALTUVIIIO has a 3 to 4 fold longer half-life relative to standard and extended half-life factor VIII products, providing high-sustained factor activity levels throughout (40%) for most of the week and at 15% at the end of the dosing interval. ALTUVIIIO is the first factor VIII therapy that has been shown to break through the von Willebrand factor ceiling, which imposes a half-life limitation on earlier generation factor VIII therapies. ALTUVIIIO builds on the innovative Fc fusion technology by adding a region of von Willebrand factor and XTENpolypeptides to extend its time in circulation. XTEN is a registered trademark of Amunix Pharmaceuticals, Inc. About the XTEND Clinical ProgramsThe XTEND clinical program is comprised of two Phase 3 trials in hemophilia A: XTEND-1 in people 12 years or older and XTEND-Kids in children younger than 12 years old. There is also an ongoing extension study (XTEND-ed). The Phase 3 XTEND-1 study (NCT04161495)wasan open-label, non-randomized interventional study assessing the safety, efficacy, and pharmacokinetics ofonce-weeklyALTUVIIIO in people 12 years of age or older (n=159) with severe hemophilia A who were previously treated with factor VIII replacement therapy.The study consisted of two parallel treatment arms the prophylaxis Arm A (n=133), in which patients who had received prior factor VIII prophylaxis were treated with once-weekly intravenousALTUVIIIO prophylaxis(50 IU/kg) for 52 weeks, and the on-demand Arm B (n=26), in which patients who had received prior on-demand factorVIIItherapy began with 26 weeks of on-demandALTUVIIIO(50 IU/kg), then switched to once-weekly prophylaxis with ALTUVIIIO (50 IU/kg) for an additional 26 weeks. The primary efficacy endpoint of XTEND-1 was the meanannualized bleeding rate (ABR)in Arm A, and the key secondary endpoint was an intra-patient comparison of ABR during the ALTUVIIIO weekly prophylaxis treatment period versus the priorfactor VIIIprophylaxis ABR for a subset of participants in Arm A whohadparticipatedin a previous observational study (Study 242HA201/OBS16221). The XTEND-Kids study (NCT04759131) was an open-label, non-randomized interventional study of the safety, efficacy, and pharmacokinetics of once-weekly ALTUVIIIO in previously treated patients younger than 12 years of age with severe hemophilia A. Patients received once-weekly ALTUVIIIO prophylaxis (50 IU/kg) for 52 weeks. The primary endpoint was the occurrence of inhibitor development. About the Sanofi and Sobi collaborationSobi and Sanofi collaborate on the development and commercialization of Alprolix and Elocta/Eloctate. The companies also collaborate on the development and commercialization of efanesoctocog alfa, or ALTUVIIIO in the US. Sobi has final development and commercialization rights in the Sobi territory (essentially Europe, North Africa, Russia and most Middle Eastern markets). Sanofi has final development and commercialization rights in North America and all other regions in the world excluding the Sobi territory. About SobiSobi is a specialised international biopharmaceutical company transforming the lives of people with rare and debilitating diseases. Providing reliable access to innovative medicines in the areas of haematology, immunology and specialty care, Sobi has approximately 1,600 employees across Europe, North America, the Middle East, Asia and Australia. In 2022, revenue amounted to SEK 18.8 billion. Sobis share (STO:SOBI) is listed on Nasdaq Stockholm. More about Sobi atsobi.com,LinkedIn andYouTube. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Media RelationsSandrine Guendoul|+ 33 6 25 09 14 25 |sandrine.guendoul@sanofi.comSally Bain|+ 1 617 834 6026 |sally.bain@sanofi.comEvan Berland | +1 215 432 0234 | evan.berland@sanofi.comKate Conway|+ 1508 364 4931 |kate.conway@sanofi.comVictor Rouault|+ 33 6 70 93 71 40 |victor.rouault@sanofi.com Investor RelationsEva Schaefer-Jansen|+ 33 7 86 80 56 39 |eva.schaefer-jansen@sanofi.comArnaud Delepine|+ 33 6 73 69 36 93 | arnaud.delepine@sanofi.comCorentine Driancourt|+ 33 6 40 56 92 21 | corentine.driancourt@sanofi.comFelix Lauscher|+ 1908612 7239 | felix.lauscher@sanofi.comTarik Elgoutni| + 1 617 710 3587 | tarik.elgoutni@sanofi.comNathalie Pham|+ 33 7 85 93 30 17 | nathalie.pham@sanofi.com Sobi Contacts:Media RelationsFor Sobi Media contacts, click here. Investor RelationsFor details on how to contact the Sobi Investor Relations Team, click here. Sanofi Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements are generally identified by the words expects, anticipates, believes, intends, estimates, plans and similar expressions. Although Sanofis management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under Risk Factors and Cautionary Statement Regarding Forward-Looking Statements in Sanofis annual report on Form 20-F for the year ended December 31, 2022. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. Attachment Source: West Corporation Feb 24, 2023: Banco Santander Press release: New Phase 3 data presented at WORLDSymposium reinforce Nexviazyme (avalglucosidase alfa) as potential new standard of care for all people living with late-onset Pompe disease New Phase 3 data presented at WORLDSymposium reinforce Nexviazyme (avalglucosidase alfa) as potential new standard of care for all people living with late-onset Pompe disease Paris, February 24, 2023. Today, at WORLDSymposiumTM, data from the Phase 3 COMET study long-term extension showed sustained treatment effect of Nexviazyme (avalglucosidase alfa) over nearly three years in late-onset Pompe disease (LOPD) patients who were treatment-naive as well as those who switched from long-time standard of care, alglucosidase alfa, during the 96-week extension period. Additionally, a separate analysis of respiratory function showed clinical benefit over two years for patients who switched to Nexviazyme regardless of prior response to alglucosidase alfa. Priya S. Kishnani, MDC.L. and Su Chen Professor of Pediatrics; Medical Director, YT and Alice Chen Pediatrics Genetics and Genomics Center; and Division Chief, Medical Genetics, Duke University Medical Center The results presented at the 2023 WORLDSymposium continue to build on the data from the clinical trials on the value and long-term impact Nexviazyme may provide for a wide variety of people living with late-onset Pompe disease, from newly diagnosed patients to those who have been previously treated with alglucosidase alfa. Further, when examining patients treated with Nexviazyme who switched from using alglucosidase alfa, these data show clinical benefit both for patients who were stable on alglucosidase alfa and those who experienced sub-optimal response or decline. Bill SiboldGlobal Head of Specialty Care, SanofiThese long-term data over nearly three years add to the robust body of evidence that consistently shows the clinical benefit and durability of effect of treatment with Nexviazyme for both treatment-experienced and treatment-naive people living with late-onset Pompe disease. We continue to learn from our 20 years of experience in Pompe disease and build on our findings in an effort to advance the standard of care. Nexviazyme is a monotherapy approved in the US and other markets for the treatment of LOPD. It is also approved for infantile-onset Pompe disease (IOPD) in certain markets outside of the US. Nexviazyme maintained treatment effect at 145 weeks The Phase 3 COMET trial enrolled 100 previously untreated LOPD patients who were randomized to receive either Nexviazyme (20 mg/kg) or alglucosidase alfa (20 mg/kg) every two weeks for 49 weeks during the double-blind primary analysis period. During the open-label extension period, long-term efficacy and safety outcomes were assessed up to 145 weeks in patients who continued their treatment with Nexviazyme (n=51), as well as those who switched to treatment with Nexviazyme from alglucosidase alfa (n=44) at the conclusion of the primary analysis period (Week 49). After nearly three years (145 weeks), changes from baseline (least squares mean [standard error]) showed: Patients who received continuous Nexviazyme treatment for 145 weeks experienced sustained improvements in respiratory and motor function, showing a 1.40 (1.21) point improvement in forced vital capacity (FVC) percent-predicted and an average increase of 20.65 (9.60) meters in walking distance as measured by the six-minute walk test (6MWT), respectively, compared to baseline.Patients who switched from alglucosidase alfa to Nexviazyme treatment during the extension period experienced stabilization of treatment effect, showing a 1.18 (1.32) point improvement in FVC percent-predicted and an average increase of 0.29 (10.42) meters in walking distance (6MWT), compared to baseline. The safety profile during treatment with Nexviazyme was comparable between both study groups (those who started Nexviazyme in the primary analysis period and those who switched to Nexviazyme during the extension period). No new safety signals were observed in patients who switched from alglucosidase alfa to Nexviazyme during the extension period. Across both Nexviazyme treatment groups, five patients discontinued treatment during the extension period due to six adverse events (AEs); four were treatment-related (ocular hyperemia, erythema, urticaria, respiratory distress), and two were non-treatment-related (acute myocardial infarction, pancreatic adenocarcinoma). Clinical benefits seen over two years for patients who switched to Nexviazyme Subgroup analyses were also performed to assess respiratory function outcomes for the 44 patients who switched to Nexviazyme in the long-term extension period of the Phase 3 COMET study. Patients were divided into two subgroups, responders (n=14) and non-responders (n=30) based on individual responses to initial treatment with alglucosidase alfa, as measured by the change in FVC percent-predicted (FVC %predicted/year) pre- (baseline-week 49) and post-switch (week 49-week 145). Findings showed clinical benefits over two years following switch to Nexviazyme regardless of prior response to alglucosidase alfa: Patients who responded to alglucosidase alfa treatment in the primary analysis period had increased respiratory function (FVC slope, 4.671.28%/yr, p<0.001), which was maintained throughout the extension period with Nexviazyme treatment (FVC slope, 0.140.94%/yr, p=0.88).Patients who did not respond to alglucosidase alfa treatment in the primary analysis period had reduced respiratory function while taking alglucosidase alfa (FVC slope, -2.120.87%/yr, p=0.016); however, switching to Nexviazyme halted this decline in the extension period (FVC slope, 0.150.61%/yr, p=0.81). About Pompedisease People living with Pompe disease have low levels of the enzyme acid alpha-glucosidase (GAA), which results in build-up of glycogen in muscle cells throughout the body, leading to irreversible damage to skeletal and cardiac muscles. Pompe disease can present as infantile-onset Pompe disease (IOPD), the most severe form of the disease with rapid onset in infancy, or late-onset Pompe disease (LOPD), which progressively damages muscles over time. If left untreated, IOPD can lead to heart failure and death within the first year of life, while people living with LOPD may require mechanical ventilation to help with breathing or a wheelchair to assist with mobility as the disease progresses. About Nexviazyme(avalglucosidasealfa) Nexviazyme (avalglucosidase alfa) is an enzyme replacement therapy (ERT) designed to target the mannose-6-phosphate (M6P) receptor, the key pathway for uptake and transport of ERT. Nexviazyme aims to help improve uptake and enhance glycogen clearance in target tissues with an average 15-fold higher level of M6P moieties as compared to alglucosidase alfa, the comparator therapy in the pivotal study. Nexviazyme is approved in multiple markets around the world for the treatment of people living with Pompe disease, including the United States, the European Union, Japan, Canada, Switzerland, Australia, Brazil, Argentina, Taiwan, the United Arab Emirates, South Korea and the United Kingdom, with specific indications varying by country. In Europe, the medicine is marketed under the brand name Nexviadyme. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Media RelationsSandrine Guendoul|+ 33 6 25 09 14 25 | sandrine.guendoul@sanofi.comKate Conway|+ 1 508 364 4931 |kate.conway@sanofi.com Investor RelationsEva Schaefer-Jansen|+ 33 7 86 80 56 39 |eva.schaefer-jansen@sanofi.comArnaud Delepine|+ 33 6 73 69 36 93 | arnaud.delepine@sanofi.comCorentine Driancourt|+ 33 6 40 56 92 21 | corentine.driancourt@sanofi.comFelix Lauscher|+ 1908612 7239 | felix.lauscher@sanofi.comTarik Elgoutni| + 1 617 710 3587 | tarik.elgoutni@sanofi.comNathalie Pham|+ 33 7 85 93 30 17 | nathalie.pham@sanofi.com Sanofi Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions, and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words expects, anticipates, believes, intends, estimates, plans and similar expressions. Although Sanofis management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofis ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. Any material effect of COVID-19 on any of the foregoing could also adversely impact us. This situation is changing rapidly, and additional impacts may arise of which we are not currently aware and may exacerbate other previously identified risks. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under Risk Factors and Cautionary Statement Regarding Forward-Looking Statements in Sanofis annual report on Form 20-F for the year ended December 31, 2022. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. Attachment Source: West Corporation Feb 24, 2023: Banco Santander ALTUVIIIO approved by the U.S. FDA: this positive event triggers impairment reversal, positively impacting 2022 IFRS net income; no change on business net income (non-IFRS) FDA approves once-weekly ALTUVIIIO, a new class of factor VIII therapy for hemophilia A that offers significant bleed protection. This positive event triggers impairment reversal, impacting 2022 IFRS net income; no change on business net income (non-IFRS) Filing of the 2022 U.S. Form 20-F and French Document dEnregistrement Universel containing the Annual Financial Report Paris, February 24, 2023. Sanofi announces today the filing of its Form 20-F with the U.S. Securities and Exchange Commission (SEC) and its Document dEnregistrement Universel containing its Annual Financial Report with the French market regulator Autorite des marches financiers (AMF). On February 22, 2023, the US Food and Drug Administration (FDA) approved ALTUVIIIOTM. This confirms the significant increase of value of the asset. That decision, which occurred prior to the filing of the French Document denregistrement universel and of the Annual Report on Form 20-F, resulted in an adjustment to IFRS net income for the year ended December 31, 2022 as presented in the Sanofi press release issued on February 3, 2023. The adjustment consisted of the reversal of 2,154 million of impairment losses against the intangible assets associated with the Eloctate franchise, in accordance with IAS 36 (Impairment of Assets); the assets had been partially written down in 2019. The adjustment is presented within the line item Impairment of intangible assets in the consolidated income statement; the net impact after tax is a gain of 1,651 million. Cash flows are not impacted by the adjustment. Following the adjustment, for the year ended December 31, 2022, IFRS net income amounts to 8,371 million (versus 6,720 million as per the press release of February 3, 2023); earnings per share (IFRS EPS) amounts to 6.69 (versus 5.37 as per the press release of February 3, 2023); and total equity amounts to 75,152 million (versus 73,512 million as per the press release of February 3, 2023). Business net income (a non-IFRS financial measure) for the year ended December 31, 2022 is unchanged, as is the amount of the dividend proposed by the Board of Directors held on February 2, 2023. Updated IFRS figures for 2022 Financial Statements1 Source: West Corporation Feb 23, 2023: Banco Santander Press Release: FDA approves once-weekly ALTUVIIIO, a new class of factor VIII therapy for hemophilia A that offers significant bleed protection FDA approves once-weekly ALTUVIIIO, a new class of factor VIII therapy for hemophilia A that offers significant bleed protection Paris and Stockholm February 23, 2023 The U.S. Food and Drug Administration (FDA) has approved ALTUVIIIO [Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein-ehtl], previously referred to as efanesoctocog alfa, a first-in-class, high-sustained factor VIII replacement therapy. ALTUVIIIO is indicated for routine prophylaxis and on-demand treatment to control bleeding episodes, as well as perioperative management (surgery) for adults and children with hemophilia A. ALTUVIIIO is the first and only hemophilia A treatment that delivers normal to near-normal factor activity levels (over 40%) for most of the week with once-weekly dosing, and significantly reduces bleeds compared to prior factor VIII prophylaxis. Paul HudsonCEO, Sanofi "Todays approval of ALTUVIIIO allows patients and physicians to reimagine living with hemophilia. The high sustained factor activity levels that can be achieved with ALTUVIIIO have the potential to change the hemophilia landscape. For the first time, with a once-weekly dose, powerful bleed protection is a reality for patients. Significant shifts in treatment paradigms that improve peoples lives, like ALTUVIIIO, are what we have committed to delivering at Sanofi. Hemophilia A is a rare, lifelong condition in which the ability of a persons blood to clot properly is impaired, leading to excessive bleeds and spontaneous bleeds into joints that can result in joint damage and chronic pain, and potentially impact quality of life. The severity of hemophilia is determined by the level of clotting factor activity in a persons blood, and there is a negative correlation between risk of bleeding and factor activity levels. Lynn Malec, MDMedical Director of Comprehensive Center for Bleeding Disorders and Associate Investigator at The Versiti Blood Research Institute, and Associate Professor of Medicine and Pediatrics at The Medical College of WisconsinThis approval marks an important clinical advancement for the hemophilia community because we have an option that can achieve higher levels of factor activity with a single simplified weekly dose. By maintaining high levels of factor activity throughout the week, patients can be confident in the bleed protection ALTUVIIIO offers. This is the first approval of ALTUVIIIO. The FDA evaluated the application under Priority Review, which is granted to therapies that have the potential to provide significant improvements in the treatment, diagnosis, or prevention of serious conditions. The FDA previously granted ALTUVIIIO Breakthrough Therapy designation in May 2022 the first factor VIII therapy to receive this recognition Fast Track designation in February 2021, and Orphan Drug designation in August 2017. Regulatory submission in the EU is anticipated in the second half of 2023. The European Commission granted Orphan Drug designation in June 2019. ALTUVIIIO helps elevate expectations for hemophilia A by providing protection for longer The FDA approval is based on data from the pivotal XTEND-1 Phase 3 study recently published in The New England Journal of Medicine. Once-weekly ALTUVIIIO prophylaxis met the primary endpoint, providing significant bleed protection for people with severe hemophilia A with a mean annualized bleeding rate (ABR) of 0.70 (95% CI: 0.5-1.0) and a median ABR of 0.0 (Q1, Q3: 0.0, 1.0). ALTUVIIIO met the key secondary endpoint with a significant reduction of 77% in ABR versus prior factor prophylaxis based on an intra-patient comparison (95% CI:58%-87%). Additional data showed prevention of joint bleeds with a median annualized joint bleeding rate of 0 (Q1, Q3: 0.0, 1.0). Treatment with ALTUVIIIO provided 100% resolution of target joints, which are joints that have recurrent bleeds (e.g., knee, ankle, or elbow). ALTUVIIIO provided mean factor VIII activity greater than 40% for most of the week and greater than 10% at Day 7; these levels were associated with a low bleed risk. In the study, ALTUVIIIO was well-tolerated and inhibitor development to factor VIII was not detected, although is possible following administration of ALTUVIIIO. Additionally, interim data from XTEND-Kids showed that children younger than 12 years of age receiving once-weekly ALTUVIIIO for 26 weeks (n=23) experienced a mean ABR of 0.5 (95% CI: 0.2-1.3) and a median ABR of 0 (Q1, Q3: 0.0, 1.3). Safety results were consistent with data from the XTEND-1 trial. The full results from XTEND-Kids will be presented at a future medical meeting. Across the studies, ALTUVIIIO has an established safety profile and there were no reports of factor VIII inhibitor development, although inhibitor formation is possible following administration of ALTUVIIIO. The most common side effects (>10%) of ALTUVIIIO are headache and arthralgia. ALTUVIIIO is indicated for routine prophylaxis, on-demand treatment and control of bleeding episodes, and perioperative management of bleeding. The simple recommended dose of 50 IU/kg is intended for all patients and for different clinical scenarios. To ensure that patients have access to the improved bleed protection provided by ALTUVIIIO, Sanofi will price ALTUVIIIO at parity to the annual cost of treating a prophylaxis patient on Eloctate [Antihemophilic Factor (Recombinant), Fc Fusion Protein]. Sanofi will also provide comprehensive patient support services and resources online and at 1.855.MyALTUVIIIO (855.692.5888). In the U.S., ALTUVIIIO is expected to be commercially available in April. About ALTUVIIIOALTUVIIIO [Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein-ehtl] is a novel von Willebrand Factor (VWF) independent recombinant factor VIII therapy that is designed to extend protection from bleeds with once-weekly prophylactic dosing for adults and children with hemophilia A. ALTUVIIIO has a 3 to 4 fold longer half-life relative to standard and extended half-life factor VIII products. It is the first factor VIII therapy that has been shown to break through the von Willebrand factor ceiling, which imposes a half-life limitation on earlier generation factor VIII therapies. ALTUVIIIO builds on the innovative Fc fusion technology by adding a region of von Willebrand factor and XTENpolypeptides to extend its time in circulation. About the XTEND Clinical ProgramsThe XTEND clinical program is comprised of two Phase 3 trials in hemophilia A: XTEND-1 in people 12 years or older and XTEND-Kids in children younger than 12 years old. There is also an ongoing extension study (XTEND-ed). The Phase 3 XTEND-1 study (NCT04161495)wasan open-label, non-randomized interventional study assessing the safety, efficacy, and pharmacokinetics ofonce-weeklyALTUVIIIO in people 12 years of age or older (n=159) with severe hemophilia A who were previously treated with factor VIII replacement therapy.The study consisted of two parallel treatment arms the prophylaxis Arm A (n=133), in which patients who had received prior factor VIII prophylaxis were treated with once-weekly intravenousALTUVIIIO prophylaxis(50 IU/kg) for 52 weeks, and the on-demand Arm B (n=26), in which patients who had received prior on-demand factorVIIItherapy began with 26 weeks of on-demandALTUVIIIO(50 IU/kg), then switched to once-weekly prophylaxis with ALTUVIIIO (50 IU/kg) for an additional 26 weeks. The primary efficacy endpoint was the meanannualized bleeding rate (ABR)in Arm A, and the key secondary endpoint was an intra-patient comparison of ABR during the ALTUVIIIO weekly prophylaxis treatment period versus the priorfactor VIIIprophylaxis ABR for a subset of participants in Arm A whohadparticipatedin a previous observational study (Study 242HA201/OBS16221). The XTEND-Kids study (NCT04759131) was an open-label, non-randomized interventional study of the safety, efficacy, and pharmacokinetics of once-weekly ALTUVIIIO in previously treated patients younger than 12 years of age (n=67) with severe hemophilia A. Patients received once-weekly ALTUVIIIO prophylaxis (50 IU/kg) for 52 weeks. About the Sanofi and Sobi collaborationSobi and Sanofi collaborate on the development and commercialization of Alprolix and Elocta/Eloctate. The companies also collaborate on the development and commercialization of efanesoctocog alfa or ALTUVIIIO in the US. Sobi has final development and commercialization rights in the Sobi territory (essentially Europe, North Africa, Russia and most Middle Eastern markets). Sanofi has final development and commercialization rights in North America and all other regions in the world excluding the Sobi territory. About SobiSobi is a specialized international biopharmaceutical company transforming the lives of people with rare diseases. Providing sustainable access to innovative medicines in the areas of haematology, immunology and specialty care, Sobi has approximately 1,600 employees across Europe, North America, the Middle East and Asia. In 2022, revenue amounted to SEK 18.8 billion. Sobis share (STO:SOBI) is listed on Nasdaq Stockholm. More about Sobi at sobi.com, LinkedIn and YouTube. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Media RelationsSandrine Guendoul|+ 33 6 25 09 14 25 |sandrine.guendoul@sanofi.comSally Bain|+ 1 617 834 6026 |sally.bain@sanofi.comEvan Berland | +1 215 432 0234 | evan.berland@sanofi.comKate Conway|+ 1508 364 4931 |kate.conway@sanofi.comVictor Rouault|+ 33 6 70 93 71 40 |victor.rouault@sanofi.com Investor RelationsEva Schaefer-Jansen|+ 33 7 86 80 56 39 |eva.schaefer-jansen@sanofi.comArnaud Delepine|+ 33 6 73 69 36 93 | arnaud.delepine@sanofi.comCorentine Driancourt|+ 33 6 40 56 92 21 | corentine.driancourt@sanofi.comFelix Lauscher|+ 1908612 7239 | felix.lauscher@sanofi.comTarik Elgoutni| + 1 617 710 3587 | tarik.elgoutni@sanofi.comNathalie Pham|+ 33 7 85 93 30 17 | nathalie.pham@sanofi.com Sobi Contacts:Media RelationsFor Sobi Media contacts, click here. Investor RelationsFor details on how to contact the Sobi Investor Relations Team, click here. Sanofi Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements are generally identified by the words expects, anticipates, believes, intends, estimates, plans and similar expressions. Although Sanofis management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. Any material effect of COVID-19 on any of the foregoing could also adversely impact us. This situation is changing rapidly and additional impacts may arise of which we are not currently aware and may exacerbate other previously identified risks. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under Risk Factors and Cautionary Statement Regarding Forward-Looking Statements in Sanofis annual report on Form 20-F for the year ended December 31, 2021. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. Attachment Source: West Corporation Feb 13, 2023: Banco Santander Press Release: Sanofi announces change in R&D leadership Sanofi announces change in R&D leadership Paris, February 13, 2023. Sanofi announced today that Dr. John Reed, its Global Head of R&D, will be leaving the company to pursue a new opportunity outside Sanofi. The company warmly thanks Dr. Reed for his leadership over these last years. Since joining Sanofi in 2018, John has laid the foundation for the companys R&D transformation. He helped reshape Sanofis discovery and development of therapeutics, focusing efforts on first and best in class medicines that have the potential to transform the practice of medicine and improve the lives of people with serious diseases, whilst managing the integration and development of new technology platforms and partnerships, and driving R&D productivity. In 2023, Sanofi will launch two first or best-in-class medicines that will address major needs in hemophilia and respiratory syncytial virus. The company expects in the next 15 months27 scientific readoutsandtwo pivotal readouts in multiple sclerosis and COPD/chronic bronchitis, also within this year. A clear step forward in Sanofis scientifically-driven roadmap. While an internal and external search has already started to identify the successor to Dr. Reed, Dr. Dietmar Berger, has agreed to take the leadership of the team ad interim. Dr. Berger has been serving as Chief Medical Officer and Global Head of Development since he joined Sanofi in 2019, after an extensive and successful career at various other pharmaceutical companies including Genentech, Bayer and Amgen. Paul HudsonCEO, SanofiUnder Johns leadership, our R&D organization has built a robust pipeline and sharpened its research focus, employing cutting-edge therapeutic platforms and creating a culture that responds to the urgent needs of patients. His contribution to our companys transformation has helped pave the way for Sanofis emergence as a science-driven and innovation leader in our industry. As we continue to build an exciting Specialty Care and Vaccines portfolio, we look forward to the growing momentum of our pipeline. This is what we were aiming for when we laid our strategy in 2019, and the 2022 results we recently published confirmed our choices. 2023 will only strengthen our commitment to transform the practice of medicine. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Media RelationsSandrine Guendoul|+ 33 6 25 09 14 25 |sandrine.guendoul@sanofi.comSally Bain|+ 1 617 834 6026 |sally.bain@sanofi.comNicolas Obrist|+ 33 6 77 21 27 55 |nicolas.obrist@sanofi.com Investor RelationsEva Schaefer-Jansen|+ 33 7 86 80 56 39 |eva.schaefer-jansen@sanofi.comArnaud Delepine|+ 33 6 73 69 36 93 | arnaud.delepine@sanofi.comCorentine Driancourt|+ 33 6 40 56 92 21 | corentine.driancourt@sanofi.comFelix Lauscher|+ 1908612 7239 | felix.lauscher@sanofi.comTarik Elgoutni| + 1 617 528 8427 |Tarik.Elgoutni@sanofi.comNathalie Pham|+ 33 7 85 93 30 17 | nathalie.pham@sanofi.com Sanofi Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words expects, anticipates, believes, intends, estimates, plans and similar expressions. Although Sanofis management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofis ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under Risk Factors and Cautionary Statement Regarding Forward-Looking Statements in Sanofis annual report on Form 20-F for the year ended December 31, 2021. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. Attachment Press_Release Source: West Corporation Feb 03, 2023: Banco Santander Press Release : Strong sales performance and double digit EPS growth marking the achievement of the 2022 profitability milestone Strong sales performance and double digit EPS growth marking the achievement of the 2022 profitability milestone Paris, February 3, 2023 Q4 2022 sales growth of 2.6% at CER and business EPS(1) growth of 17.4% at CER Full-year 2022 delivered 7.0% sales growth and 17.1% business EPS growth at CER Progress on Corporate Social Responsibility strategy in Q4 Positive phase 2/3 results of acoziborole with the potential to further transform the treatment of sleeping sickness Accelerating our ambition towards net zero emissions by 5 years, now targeting 2045 Key R&D milestones and regulatory achievements in Q4 Dupixent approved in Europe for prurigo nodularis and CHMP positive opinion for eosinophilic esophagitisBeyfortus (nirsevimab) approved in Europe for the prevention of RSV disease in all infantsVidPrevtyn Beta approved in Europe as a booster for the prevention of COVID-19 in adults Enjaymo approved in Europe in adult patients with cold agglutinin disease (CAD) Full-year 2023 business EPS guidance Sanofi Chief Executive Officer, Paul Hudson, commented: We closed 2022, marking the successful execution of the first chapter of our 6-year Play to Win strategy. Specialty Care delivered the highest sales among our businesses. Dupixent and Vaccines continue to be our leading growth drivers. We are particularly proud of the progress we made in R&D transformation with multiple approvals of transformative medicines and new product launches across Specialty Care. At the same time, we keep delivering strong proof points of our improved financial performance underpinned by the achievement of the 30% BOI margin. Moving to the next chapter of our strategy, we are looking forward to the planned launches of Altuviiio and Beyfortus as well as key pivotal readouts, including the COPD indication for Dupixent. With the view on the expected entrants of generic competition for Aubagio in the coming months, we remain confident in our outstanding commercial capabilities, including the ambition to reach sales of 10 billion euros for Dupixent in 2023, enabling us to guide to low single-digit EPS growth for the year. Source: West Corporation Jan 30, 2023: Banco Santander Press Release: Dupixent (dupilumab) approved by European Commission as the first and only targeted medicine indicated for eosinophilic esophagitis Dupixent (dupilumab) approved by European Commission as the first and only targeted medicine indicated for eosinophilic esophagitis Approximately 60% of patients aged 12 years and older treated with Dupixent 300 mg weekly in the pivotal trial experienced histological disease remission; patients also significantly improved their ability to swallow compared to placeboDupixent is now an option for the approximately 50,000 adults and adolescents living with severe uncontrolled eosinophilic esophagitis in the European Union (EU)Dupixent now approved to treat five diseases with underlying type 2 inflammation in the EU Paris and Tarrytown, N.Y. Jan 30, 2023. The European Commission (EC) has expanded the marketing authorization for Dupixent(dupilumab) in the European Union (EU) to treat eosinophilic esophagitis (EoE) in adults and adolescents 12 years and older, weighing at least 40 kg, who are inadequately controlled by, are intolerant to, or who are not candidates for conventional medicinal therapy. EoE is a chronic, progressive inflammatory disease that damages the esophagus and prevents it from working properly. With this approval, Dupixent is the first and only targeted medicine specifically indicated to treat EoE in Europe and the U.S. Naimish Patel,M.D.HeadofGlobal Development, Immunology and Inflammation atSanofiThe impact of EoE on a patients daily life cannot be overstated the narrowing and scarring of the esophagus can make something as simple as eating a painful and distressing experience, and may lead to choking and food impaction. With this latest approval for Dupixent, adults and adolescents in the EU suffering from the chronic and often debilitating symptoms of EoE now have the first and only targeted treatment option clinically proven to reduce both esophageal inflammation and damage, as well as improve swallowing ability, pain and health-related quality of life. George D. Yancopoulos, M.D., Ph.D.President and Chief Scientific Officer at RegeneronThis latest approval establishes Dupixent as the only targeted medicine specifically indicated for eosinophilic esophagitis in the European Union. Dupixent is also the only biologic shown in pivotal trials to help patients achieve histological remission, reduce difficulty swallowing and improve health-related quality of life all of which are crucial to reducing the burden of this debilitating disease. Since its first approval, Dupixent has redefined the treatment of certain chronic diseases with underlying type 2 inflammation and is now indicated for five conditions in the European Union. We remain committed to investigating Dupixents potential in additional diseases in which IL-4 and IL-13 may play a key role. The EC decision is supported by 52-week data from a Phase 3 trial consisting of three parts (Part A, B and C). Part A and Part B investigated Dupixent 300 mg weekly (Part A n=42; Part B n=80) compared to placebo (Part A n=39; Part B n=79) for 24 weeks. Part C (n=188) observed patients who had continued on or switched to Dupixent from Parts A and B for an additional 28 weeks. Dupixent patients in Parts A and B, respectively, experienced: An approximately 10 times higher rate of histological disease remission (60% and 59%), a co-primary endpoint, compared to placebo (5% and 6%).A 69% and 64% reduction in disease symptoms compared to 32% and 41% with placebo. Disease symptoms were measured using the Dysphagia Symptom Questionnaire (DSQ), on which Dupixent patients experienced a 21.9- and 23.8-point clinically meaningful improvement compared to a 9.6- and 13.9-point improvement for placebo, a co-primary endpoint. Swallowing improvement was observed as early as four weeks.A greater than seven-fold reduction in abnormal endoscopic findings from baseline (-3.2 and -4.5 points) compared to placebo (-0.3 and -0.6 points). Nominally significant improvements in swallowing-related pain and health-related quality of life, as well as less frequent non-swallowing symptoms. Histological disease remission, swallowing improvement and reduction in abnormal endoscopic findings were consistent with the overall population in patients who were uncontrolled, or not responsive to or not eligible for swallowed topical corticosteroids. Longer term efficacy in Part C was similar to results observed in Parts A and B. The safety results of the trial were generally consistent with the known safety profile of Dupixent in its approved indications. The most common side effects across indications include injection site reactions, conjunctivitis, conjunctivitis allergic, arthralgia, oral herpes and eosinophilia. Adverse events more commonly observed in EoE patients treated with Dupixent (n=122) compared to placebo (n=117) included infections (32% vs. 25%). An additional adverse reaction of injection site bruising was reported in the EoE trial. The safety profile through 52 weeks was generally consistent with the safety profile observed at 24 weeks. About Eosinophilic Esophagitis EoE is a chronic, progressive inflammatory disease that damages the esophagus and prevents it from working properly. The results seen with Dupixent in adults and adolescents with EoE demonstrate that interleukin-4 (IL-4) and interleukin-13 (IL-13) are key and central drivers of the type 2 inflammation underlying this disease. For people with EoE, swallowing even small amounts of food can be a painful and worrisome choking experience. They are often left to contend with the frustration and anxiety of a constantly evolving list of foods to avoid, a poor quality of life and a higher risk of depression. In cases where EoE causes the esophagus to narrow, forced and potentially painful dilation (physical expansion) of the esophagus may be needed. In severe cases, a feeding tube may be the only option to ensure proper caloric intake and adequate nutrition. In the EU, about 50,000 adults and adolescents live with severe uncontrolled EoE. About the Dupixent Eosinophilic Esophagitis Trial The three-part Phase 3 randomized, double-blind, placebo-controlled trial evaluated the efficacy and safety of Dupixent in patients aged 12 years and older with EoE. All patients had previously not responded to proton pump inhibitors, and, across Parts A and B, 74% of patients were previously treated with swallowed topical corticosteroids. At 24 weeks, the co-primary endpoints in Parts A and B assessed patient-reported measures of difficulty swallowing (change from baseline in the DSQ on a 0-84 scale) and esophageal inflammation (proportion of patients achieving histological disease remission, defined as peak esophageal intraepithelial eosinophil count of 6 eos/hpf). Additional endpoints included abnormal endoscopic findings (EoE Endoscopic Reference Score [EoE-EREFS] on a 0-18 scale), swallowing-related pain (DSQ pain score), health-related quality of life (EoE Impact Questionnaire [EoE-IQ]) and frequency of other non-dysphagia symptoms (EoE Symptom Questionnaire [EoE-SQ]). About Dupixent Dupixent is an injection administered under the skin (subcutaneous injection) at different injection sites. In the EU for adolescents and adults with EoE, Dupixent is administered at 300 mg every week. It is available as both a pre-filled pen and pre-filled syringe at the 300 mg dose. Dupixent is intended for use under the guidance of a healthcare professional and can be given in a clinic or at home by self-administration after training by a healthcare professional. Dupixent is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not an immunosuppressant. The Dupixent development program has shown significant clinical benefit and a decrease in type 2 inflammation in Phase 3 trials, establishing that IL-4 and IL-13 are key and central drivers of the type 2 inflammation that plays a major role in multiple related and often co-morbid diseases. These diseases include approved indications for Dupixent, such as atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), prurigo nodularis and EoE. Dupixent has received regulatory approvals in one or more countries around the world for use in certain patients with atopic dermatitis, asthma, CRSwNP, EoE or prurigo nodularis in different age populations. Dupixent is currently approved for one or more of these indications in more than 60 countries, including in Europe, the U.S. and Japan. More than 500,000 patients have been treated with Dupixent globally. Dupilumab Development Program Dupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement. To date, dupilumab has been studied across more than 60 clinical trials involving more than 10,000 patients with various chronic diseases driven in part by type 2 inflammation. In addition to the currently approved indications, Sanofi and Regeneron are studying dupilumab in a broad range of diseases driven by type 2 inflammation or other allergic processes in Phase 3 trials, including pediatric EoE, hand and foot atopic dermatitis, chronic inducible urticaria-cold, chronic spontaneous urticaria, chronic pruritus of unknown origin, chronic obstructive pulmonary disease with evidence of type 2 inflammation, chronic rhinosinusitis without nasal polyposis, allergic fungal rhinosinusitis, allergic bronchopulmonary aspergillosis and bullous pemphigoid. These potential uses of dupilumab are currently under clinical investigation, and the safety and efficacy in these conditions have not been fully evaluated by any regulatory authority. About Regeneron Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led for 35 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, hematologic conditions, infectious diseases and rare diseases. Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite technologies, such as VelocImmune, which uses unique genetically humanized mice to produce optimized fully human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world. For more information, please visit www.Regeneron.com or follow @Regeneron on Twitter. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Sanofi Media RelationsSally Bain|+ 1 617 834 6026 |sally.bain@sanofi.com Sanofi Investor RelationsEva Schaefer-Jansen | + 33 7 86 80 56 39 | eva.schaefer-jansen@sanofi.com Arnaud Delepine | + 33 06 73 69 36 93 | arnaud.delepine@sanofi.com Corentine Driancourt | + 33 06 40 56 92 21 | corentine.driancourt@sanofi.com Felix Lauscher | + 1 908 612 7239 | felix.lauscher@sanofi.com Priya Nanduri |+ 1 617 764 6418 | priya.nanduri@sanofi.com Nathalie Pham | + 33 07 85 93 30 17 | nathalie.pham@sanofi.com Regeneron Media RelationsIlana Yellen | + 1 914 330 9618 |ilana.yellen@regeneron.com Regeneron Investor RelationsVesna Tosic | + 914 847 5443 | vesna.tosic@regeneron.com Sanofi Disclaimers or Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements are generally identified by the words "expects", "anticipates", "believes", "intends", "estimates", "plans" and similar expressions. Although Sanofi's management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. Any material effect of COVID-19 on any of the foregoing could also adversely impact us. This situation is changing rapidly and additional impacts may arise of which we are not currently aware and may exacerbate other previously identified risks. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in Sanofi's annual report on Form 20-F for the year ended December 31, 2021. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. Regeneron Forward-Looking Statements and Use of Digital Media This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. (Regeneron or the Company), and actual events or results may differ materially from these forward-looking statements. Words such as anticipate, expect, intend, plan, believe, seek, estimate, variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the impact of SARS-CoV-2 (the virus that has caused the COVID-19 pandemic) on Regenerons business and its employees, collaborators, and suppliers and other third parties on which Regeneron relies, Regenerons and its collaborators ability to continue to conduct research and clinical programs, Regenerons ability to manage its supply chain, net product sales of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, Regenerons Products), and the global economy; the nature, timing, and possible success and therapeutic applications of Regenerons Products and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, Regenerons Product Candidates) and research and clinical programs now underway or planned, including without limitation Dupixent (dupilumab) for the treatment of adults and adolescents with eosinophilic esophagitis (EoE); uncertainty of the utilization, market acceptance, and commercial success of Regenerons Products and Regenerons Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary), including the studies discussed or referenced in this press release, on any of the foregoing; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regenerons Product Candidates and new indications for Regenerons Products, such as Dupixent for the treatment of pediatric EoE, hand and foot atopic dermatitis, chronic inducible urticaria-cold, chronic spontaneous urticaria, chronic pruritus of unknown origin, chronic obstructive pulmonary disease with evidence of type 2 inflammation, chronic rhinosinusitis without nasal polyposis, allergic fungal rhinosinusitis, bullous pemphigoid, and other potential indications; the ability of Regenerons collaborators, licensees, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regenerons Products and Regenerons Product Candidates; the ability of Regeneron to manage supply chains for multiple products and product candidates; safety issues resulting from the administration of Regenerons Products (such as Dupixent) and Regenerons Product Candidates in patients, including serious complications or side effects in connection with the use of Regenerons Products and Regenerons Product Candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict Regenerons ability to continue to develop or commercialize Regenerons Products and Regenerons Product Candidates, including without limitation Dupixent; ongoing regulatory obligations and oversight impacting Regenerons Products, research and clinical programs, and business, including those relating to patient privacy; the availability and extent of reimbursement of Regenerons Products from third-party payers, including private payer healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payers and new policies and procedures adopted by such payers; competing drugs and product candidates that may be superior to, or more cost effective than, Regenerons Products and Regenerons Product Candidates; the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators or licensees may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license, collaboration, or supply agreement, including Regenerons agreements with Sanofi and Bayer (or their respective affiliated companies, as applicable) to be cancelled or terminated; and risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA (aflibercept) Injection, Praluent (alirocumab), and REGEN-COV (casirivimab and imdevimab)), other litigation and other proceedings and government investigations relating to the Company and/or its operations, the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regenerons business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regenerons filings with the U.S. Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2021 and its Form 10-Q for the quarterly period ended September 30, 2022. Any forward-looking statements are made based on managements current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise.Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regenerons media and investor relations website (http://newsroom.regeneron.com) and its Twitter feed (http://twitter.com/regeneron). Attachment Source: West Corporation Jan 27, 2023: Banco Santander Press Release: Dupixent (dupilumab) recommended for expanded EU approval by the CHMP to treat children as young as six months old with severe atopic dermatitis Dupixent (dupilumab) recommended for expanded EU approval by the CHMP to treat children as young as six months old with severe atopic dermatitis If approved, Dupixent would be the first and only targeted medicine in the EU for these young childrenRecommendation based on a Phase 3 trial in children 6 months to 5 years old showing Dupixent improved skin clearance, reduced overall disease severity and improved health-related quality of lifeIn Europe, about 80,000 children aged 6 months to 5 years old with uncontrolled severe atopic dermatitis are candidates for systemic therapy Paris and Tarrytown, N.Y. January 27, 2023. The European Medicines Agencys Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Dupixent (dupilumab), recommending expanded approval in the European Union (EU) to treat severe atopic dermatitis in children 6 months to 5 years old who are candidates for systemic therapy. The European Commission is expected to announce a final decision on the Dupixent application in the coming months. In June 2022, Dupixent was approved by the U.S. Food and Drug Administration for children in this age group. Atopic dermatitis is a chronic type 2 inflammatory skin disease. Between 85% and 90% of patients first develop symptoms before 5 years of age, which can often continue through adulthood. Symptoms include intense, persistent itch and skin lesions that cover much of the body, resulting in skin dryness, cracking, pain, redness or darkening, crusting and oozing, which can increase the risk of skin infection. Severe atopic dermatitis may also significantly impact the quality of life of young children and their caregivers. Current treatment options in this age group are primarily topical corticosteroids (TCS), which can be associated with safety risks and may impair growth when used long-term. The positive CHMP opinion is supported by data from a Phase 3 trial in children 6 months to 5 years of age recently published in The Lancet, which met all primary and secondary endpoints. At 16 weeks, Dupixent plus low-potency TCS improved skin clearance and reduced overall disease severity compared to TCS alone (the placebo arm). Dupixent patients also experienced reduced itch and skin pain as well as improved sleep quality and health-related quality of life compared to placebo. Long-term data further showed a sustained improvement in these disease measures up to one year. Safety results were generally consistent with the known safety profile of Dupixent in atopic dermatitis. Adverse events more commonly observed with Dupixent in this atopic dermatitis population compared to placebo included conjunctivitis and eosinophilia. The use of Dupixent in infants and young children less than 6 years of age with severe atopic dermatitis is investigational in the EU and is not yet approved. About Dupixent Dupixent is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not an immunosuppressant. The Dupixent development program has shown significant clinical benefit and a decrease in type 2 inflammation in Phase 3 trials, establishing that IL-4 and IL-13 are key and central drivers of the type 2 inflammation that plays a major role in multiple related and often co-morbid diseases. These diseases include approved indications for Dupixent, such as atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP) and prurigo nodularis, as well as investigational diseases such as eosinophilic esophagitis (EoE) in the EU. Dupixent has received regulatory approvals in one or more countries around the world for use in certain patients with atopic dermatitis, prurigo nodularis, asthma, CRSwNP or EoE in different age populations. Dupixent is currently approved for one or more of these indications in more than 60 countries, including in Europe, the U.S. and Japan. More than 500,000 patients have been treated with Dupixent globally. Dupilumab Development Program Dupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement. To date, dupilumab has been studied across more than 60 clinical trials involving more than 10,000 patients with various chronic diseases driven in part by type 2 inflammation. In addition to the currently approved indications, Sanofi and Regeneron are studying dupilumab in a broad range of diseases driven by type 2 inflammation or other allergic processes in Phase 3 trials, including pediatric EoE, hand and foot atopic dermatitis, chronic inducible urticaria-cold, chronic spontaneous urticaria, chronic pruritus of unknown origin, chronic obstructive pulmonary disease with evidence of type 2 inflammation, chronic rhinosinusitis without nasal polyposis, allergic fungal rhinosinusitis, allergic bronchopulmonary aspergillosis and bullous pemphigoid. These potential uses of dupilumab are currently under clinical investigation, and the safety and efficacy in these conditions have not been fully evaluated by any regulatory authority. About Regeneron Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led for 35 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, hematologic conditions, infectious diseases and rare diseases. Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite technologies, such as VelocImmune, which uses unique genetically humanized mice to produce optimized fully human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world. For more information, please visit www.Regeneron.com or follow @Regeneron on Twitter. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Sanofi Media RelationsSally Bain|+ 1 617 834 6026 |sally.bain@sanofi.com Sanofi Investor RelationsEva Schaefer-Jansen | + 33 7 86 80 56 39 | eva.schaefer-jansen@sanofi.com Arnaud Delepine | + 33 06 73 69 36 93 | arnaud.delepine@sanofi.com Corentine Driancourt | + 33 06 40 56 92 21 | corentine.driancourt@sanofi.com Felix Lauscher | + 1 908 612 7239 | felix.lauscher@sanofi.com Priya Nanduri |+ 1 617 764 6418 | priya.nanduri@sanofi.com Nathalie Pham | + 33 07 85 93 30 17 | nathalie.pham@sanofi.com Regeneron Media RelationsHannah Kwagh | + 1 914 847 6315 | hannah.kwagh@regeneron.com Regeneron Investor RelationsVesna Tosic | + 914 847 5443 | vesna.tosic@regeneron.com Sanofi Disclaimers or Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements are generally identified by the words "expects", "anticipates", "believes", "intends", "estimates", "plans" and similar expressions. Although Sanofi's management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. Any material effect of COVID-19 on any of the foregoing could also adversely impact us. This situation is changing rapidly and additional impacts may arise of which we are not currently aware and may exacerbate other previously identified risks. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in Sanofi's annual report on Form 20-F for the year ended December 31, 2021. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. Regeneron Forward-Looking Statements and Use of Digital Media This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance ofRegeneron Pharmaceuticals, Inc.(Regeneron or the Company), and actual events or results may differ materially from these forward-looking statements. Words such as anticipate, expect, intend, plan, believe, seek, estimate, variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the impact of SARS-CoV-2 (the virus that has caused the COVID-19 pandemic) on Regenerons business and its employees, collaborators, and suppliers and other third parties on which Regeneron relies, Regenerons and its collaborators ability to continue to conduct research and clinical programs, Regenerons ability to manage its supply chain, net product sales of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, Regenerons Products), and the global economy; the nature, timing, and possible success and therapeutic applications of Regenerons Products and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, Regenerons Product Candidates) and research and clinical programs now underway or planned, including without limitation Dupixent (dupilumab); the impact of the opinion adopted by the European Medicines Agency's Committee for Medicinal Products for Human Use discussed in this press release on the potential approval by the European Commission of Dupixent to treat severe atopic dermatitis in children 6 months to 5 years who are candidates for systemic therapy; uncertainty of the utilization, market acceptance, and commercial success of Regenerons Products and Regenerons Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary), including the studies discussed or referenced in this press release, on any of the foregoing or any potential regulatory approval of Regenerons Products and Regenerons Product Candidates; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regenerons Product Candidates and new indications for Regenerons Products, such asthe potential approval by the European Commission of Dupixent to treat severe atopic dermatitis in children 6 months to 5 years who are candidates for systemic therapy, as well as Dupixent for the treatment of including pediatric eosinophilic esophagitis, hand and foot atopic dermatitis, chronic inducible urticaria-cold, chronic spontaneous urticaria, chronic pruritus of unknown origin, chronic obstructive pulmonary disease with evidence of type 2 inflammation, chronic rhinosinusitis without nasal polyposis, allergic fungal rhinosinusitis, bullous pemphigoid, and other potential indications; the ability of Regenerons collaborators, licensees, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regenerons Products and Regenerons Product Candidates; the ability of Regeneron to manage supply chains for multiple products and product candidates; safety issues resulting from the administration of Regenerons Products (such as Dupixent) and Regenerons Product Candidates in patients, including serious complications or side effects in connection with the use of Regenerons Products and Regenerons Product Candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict Regenerons ability to continue to develop or commercialize Regenerons Products and Regenerons Product Candidates, including without limitation Dupixent; ongoing regulatory obligations and oversight impacting Regenerons Products, research and clinical programs, and business, including those relating to patient privacy; the availability and extent of reimbursement of Regenerons Products from third-party payers, including private payer healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payers and new policies and procedures adopted by such payers; competing drugs and product candidates that may be superior to, or more cost effective than, Regenerons Products and Regenerons Product Candidates; the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators or licensees may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license, collaboration, or supply agreement, including Regenerons agreements with Sanofi and Bayer (or their respective affiliated companies, as applicable) to be cancelled or terminated; and risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA(aflibercept) Injection, Praluent(alirocumab), and REGEN-COV (casirivimab and imdevimab)), other litigation and other proceedings and government investigations relating to the Company and/or its operations, the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regenerons business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regenerons filings with theU.S. Securities and Exchange Commission, including its Form 10-K for the year endedDecember 31, 2021 and its Form 10-Q for the quarterly period ended September 30, 2022. Any forward-looking statements are made based on managements current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise. Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regenerons media and investor relations website (http://newsroom.regeneron.com) and its Twitter feed (http://twitter.com/regeneron). Attachment Press Release Source: West Corporation Jan 25, 2023: Banco Santander Press Release: NEJM publishes once-weekly efanesoctocog alfa Phase 3 data demonstrating its potential to transform the treatment landscape for people with hemophilia A NEJM publishes once-weekly efanesoctocog alfa Phase 3 data demonstrating its potential to transform the treatment landscape for people with hemophilia A Paris and Stockholm January 25, 2023 Pivotal study data published in The New England Journal of Medicine (NEJM) continues to highlight the efficacy, safety, and pharmacokinetic profile of efanesoctocog alfa, an investigational treatment for hemophilia A. These data demonstrate that efanesoctocog alfa delivered normal to near-normal factor activity levels (>40%) for the majority of the week with once-weekly dosing. Efanesoctocog alfa is currently under priority review by the United States Food and Drug Administration (FDA) and the target action date for the decision is February 28, 2023. Hemophilia A is a rare, lifelong condition in which the ability of a persons blood to clot properly is impaired, leading to excessive bleeds that can result in joint damage and chronic pain, and potentially impact their quality of life. The severity of hemophilia is determined by the level of clotting factor activity in a persons blood. Angela Weyand, MD Investigator of the XTEND-1 Clinical Trial and Associate Professor at Michigan Medicine We are excited about the potential for efanesoctocog alfa to address unmet needs by allowing people living with hemophilia to enjoy an active lifestyle. Currently, they often need to make trade-offs between bleed protection and dosing frequency. Based on the XTEND-1 study results assessing efanesoctocog alfa, we have the opportunity to provide near normal factor activity levels for an extended period of time (the majority of a week) with a single dose, which is a first for hemophilia A. The data show that efanesoctocog alfa can offer patients increased bleed protection, leading to improved outcomes, such as reduced pain and improved physical functioning, that may impact daily life with a reduced treatment burden. The data from the pivotal XTEND-1 Phase 3 study published in NEJM show that efanesoctocog alfa met primary and key secondary endpoints, demonstrating clinically meaningful prevention of bleeds and superior bleed protection compared to prior factor VIII prophylaxis based on an intra-patient comparison. Treatment with efanesoctocog alfa prophylaxis resulted in significant and clinically meaningful improvements in physical health, pain, and joint health. Key results include: The median and mean annualized bleeding rates (ABR) were 0.00 (IQR: 0.00-1.04) and 0.71 (95% CI: 0.52-0.97), respectively.A statistically significant and clinically meaningful reduction in ABR (77%) versus prior factor VIII prophylaxis (p<0.001).Nearly all (97%) bleeding episodes resolved with a single injection of efanesoctocog alfa (50 IU/kg).Efanesoctocog alfa provided mean factor activity >40 IU/dL for the majority of the week and at 15 IU/dL at Day 7.Efanesoctocog alfa prophylaxis improved physical health (p<0.001), pain intensity (p=0.03), and joint health (p=0.01) when comparing 52 week and baseline measurements.iIn patients with target joints at baseline, 100% of the target joints were resolved after at least 12 months of continuous prophylaxis.Efanesoctocog alfa was well-tolerated, and inhibitor development to factor VIII was not detected. The most common treatment-emergent adverse events (>5% of participants overall) were headache, arthralgia, fall, and back pain. Dietmar Berger, MD, PhDGlobal Head of Development and Chief Medical Officer at Sanofi We are steadfast in our commitment to developing novel treatment options that have a meaningful impact for patients. We are hopeful that Altuviiio (efanesoctocog alfa) will help deliver on this goal by offering unprecedented factor activity levels with once-weekly dosing, fulfilling its potential as a best-in-class therapy for hemophilia A. Quality of life data from the XTEND-1 study were recently presented at the 64th American Society of Hematology (ASH) Annual Meeting & Exposition. The findings provided further evidence of the potential positive impact of once-weekly efanesoctocog alfa prophylaxis to provide normal to near-normal factor activity levels for the majority of the week, reduce pain, and improve physical functioning for people with hemophilia A. About Phase 3 XTEND-1 Study (NCT04161495)The Phase 3 XTEND-1 study (NCT04161495)wasan open-label, non-randomized interventional study assessing the safety, efficacy, and pharmacokinetics ofonce-weeklyefanesoctocog alfa in people 12 years of age or older (n=159) with severe hemophilia A who were previously treated with factor VIII replacement therapy.The study consisted of two parallel treatment arms the prophylaxis Arm A (n=133), in which patients who had received prior factor VIII prophylaxis were treated with once-weekly intravenousefanesoctocog alfa prophylaxis(50 IU/kg) for 52 weeks, and the on-demand Arm B (n=26), in which patients who had received prior on-demand factorVIIItherapy began 26 weeks of on-demandefanesoctocog alfa (50 IU/kg), then switched to once-weekly prophylaxis (50 IU/kg) for an additional 26 weeks. The primary efficacy endpoint was theannualized bleeding rate (ABR)in Arm A, and the key secondary endpoint was an intra-patient comparison of ABR during the efanesoctocog alfa weekly prophylaxis treatment period versus the priorfactor VIIIprophylaxis ABR for participants in Arm A whohadparticipatedin a previous observational study (Study 242HA201/OBS16221). About hemophilia AHemophilia A is a rare, genetic disorder in which the ability of a persons blood to clot is impaired due to a missing or defective factor VIII clotting protein. Hemophilia A occurs in about one in 5,000 male births annually, and more rarely in females. People with hemophilia can experience bleeding episodes that can cause pain, irreversible joint damage and life-threatening hemorrhages. Factor replacement therapy remains a cornerstone of care and can be used across multiple treatment scenarios. About efanesoctocog alfaEfanesoctocog alfa is a novel and investigational recombinant factor VIII therapy that is designed to extend protection from bleeds with once-weekly prophylactic dosing for people with hemophilia A. It builds on the innovative Fc fusion technology by adding a region of von Willebrand factor and XTEN polypeptides to extend its time in circulation. It is the first investigational factor VIII therapy that has been shown to break through the von Willebrand factor ceiling, which imposes a half-life limitation on current factor VIII therapies. Altuviiio is the intended trade name of efanesoctocog alfa in the US, but it could differ in other territories as per the local regulatory requirements; formerly known as BIVV001. Efanesoctocog alfa is currently under clinical investigation and its safety and efficacy have not been evaluated by any regulatory authority. Efanesoctocog alfa is currently under FDA review and the target action date for the decision is February 28, 2023. The FDA also granted efanesoctocog alfa Breakthrough Therapy designation in May 2022, the first factor VIII therapy to receive this recognition Fast Track designation in February 2021, and Orphan Drug designation in August 2017. Regulatory submission in the EU, anticipated in the second half of 2023, will follow availability of data from the ongoing, fully recruited XTEND-Kids paediatric study, expected in the first half of 2023. The European Commission granted efanesoctocog alfa orphan designation in June 2019. Sanofi and Sobi collaborate on the development of efanesoctocog alfa. About the Sanofi and Sobi collaborationSobi and Sanofi collaborate on the development and commercialization of Alprolixand Elocta/Eloctate.The companies also collaborate on the development and commercialization of efanesoctocog alfa. Sobi has final development and commercialization rights in the Sobi territory (essentially Europe, North Africa, Russia and most Middle Eastern markets). Sanofi has final development and commercialization rights in North America and all other regions in the world excluding the Sobi territory. About SobiSobi is a specialized international biopharmaceutical company transforming the lives of people with rare diseases. Providing sustainable access to innovative medicines in the areas of haematology, immunology and specialty care, Sobi has approximately 1,600 employees across Europe, North America, the Middle East and Asia. In 2021, revenue amounted to SEK 15.5 billion. Sobis share (STO:SOBI) is listed on Nasdaq Stockholm. More about Sobi at sobi.com, LinkedIn and YouTube. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY. iPhysical health was assessed with the Haem-A-QoL Physical Health score. Pain intensity was assessed using the PROMIS Pain Intensity 3a past 7 days intensity of pain at its worst score. Sanofi Contacts:Media RelationsSandrine Guendoul|+ 33 6 25 09 14 25 |sandrine.guendoul@sanofi.comSally Bain|+ 1 617 834 6026 |sally.bain@sanofi.comKate Conway|+ 1508364 4931 |kate.conway@sanofi.com Investor RelationsEva Schaefer-Jansen|+ 33 7 86 80 56 39 |eva.schaefer-jansen@sanofi.comArnaud Delepine|+ 33 6 73 69 36 93 | arnaud.delepine@sanofi.comCorentine Driancourt|+ 33 6 40 56 92 21 | corentine.driancourt@sanofi.comFelix Lauscher|+ 1908612 7239 | felix.lauscher@sanofi.comPriya Nanduri|+ 1 617 764 6418 | priya.nanduri@sanofi.com Nathalie Pham|+ 33 7 85 93 30 17 | nathalie.pham@sanofi.com Sobi Contacts:Media RelationsFor Sobi Media contacts, click here. Investor RelationsFor details on how to contact the Sobi Investor Relations Team, click here. Sanofi Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words expects, anticipates, believes, intends, estimates, plans and similar expressions. Although Sanofis management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofis ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. Any material effect of COVID-19 on any of the foregoing could also adversely impact us. This situation is changing rapidly and additional impacts may arise of which we are not currently aware and may exacerbate other previously identified risks. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under Risk Factors and Cautionary Statement Regarding Forward-Looking Statements in Sanofis annual report on Form 20-F for the year ended December 31, 2021. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. Attachment Press Release Source: West Corporation Jan 11, 2023: Banco Santander Press Release: Sanofi Ventures announces multi-year capital commitment from Sanofi, increasing evergreen fund to $750M Sanofi Ventures announces multi-year capital commitment from Sanofi, increasing evergreen fund to $750M Fund focuses on early stage investing, company co-creation, leading financing rounds and is committed to continuing its investment reach by prioritizing companies advancing innovation Paris, January 11, 2023 Sanofi Ventures has announced an additional multi-year commitment from Sanofi, with an increase in capital to more than $750 million to the evergreen venture fund. In addition to serving as a financial partner to top-tier early-to-mid-stage portfolio companies, the fund supports future efforts for business development and M&A opportunities within Sanofi. The additional capital, confirmed by the executive committee, will also fuel the expansion and investment capacity of the Sanofi Ventures investment team on a global scale. Paul HudsonChief Executive Officer, SanofiSanofis purpose in chasing the miracles of science reaches far beyond our labs. As we continue to build our best-in-class pipeline, we are investing in early stage companies that share our ambition of delivering transformative science and digital innovation. This capital commitment signals Sanofis accelerated ambitions in the venture capital community and our continued desire to collaborate with global innovators in the best interests of patients. Jason P. Hafler Managing Director, Sanofi VenturesWe are grateful for Sanofis support over the past decade and appreciate their renewed commitment to early stage innovations that will fuel the next generation of transformative companies aiming to improve the lives of patients. Sanofi Ventures invests in top innovators working in areas including immunology and inflammation, rare diseases, oncology, cell and gene therapy, vaccines, and digital health and data science. The team partners across all stages of the private company lifecycle, from Seed to Series B and beyond, leading financings, serving on boards, and taking pride in working alongside portfolio companies to drive long-term value. In 2022, Sanofi Ventures closed 10 investments in global therapeutic and digital areas of strategic interest to Sanofi. Since its inception, 80% of investments have been in biotherapeutics and 20% have been in digital health companies. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Media RelationsSandrine Guendoul|+ 33 6 25 09 14 25 |sandrine.guendoul@sanofi.comSally Bain|+ 1 617 834 6026 |sally.bain@sanofi.comKate Conway|+ 1508 364 4931 |kate.conway@sanofi.com Sanofi Investor RelationsEva Schaefer-Jansen | + 33 7 86 80 56 39 | eva.schaefer-jansen@sanofi.comArnaud Delepine | + 33 06 73 69 36 93 | arnaud.delepine@sanofi.comCorentine Driancourt | + 33 06 40 56 92 21 | corentine.driancourt@sanofi.comFelix Lauscher | + 1 908 612 7239 | felix.lauscher@sanofi.comPriya Nanduri | + 1 617 764 6418 | priya.nanduri@sanofi.comNathalie Pham | + 33 07 85 93 30 17 | nathalie.pham@sanofi.com Sanofi Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words expects, anticipates, believes, intends, estimates, plans and similar expressions. Although Sanofis management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofis ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under Risk Factors and Cautionary Statement Regarding Forward-Looking Statements in Sanofis annual report on Form 20-F for the year ended December 31, 2021. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. Attachment Source: West Corporation Jan 05, 2023: Banco Santander Press Release: FDA accepts nirsevimab application as first protective option against RSV disease for all infants FDA accepts nirsevimab application as first protective option against RSV disease for all infants Nirsevimab would be the first broadly protective option against RSV disease designed for all infants, if approvedNirsevimab delivered consistent protection of approximately 80% against medically attended RSV disease across several trials in healthy term and preterm infants and has been approved under accelerated review in the EU and the UK Paris, January 5, 2023. The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) has accepted the Biologics License Application (BLA) for nirsevimab for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants entering or during their first RSV season and for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season. Nirsevimab is being developed jointly by Sanofi and AstraZeneca and, if approved, would be the first protective option for the broad infant population, including those born healthy, at term or preterm, or with specific health conditions. The FDA has indicated they will work to expedite their review. The Prescription Drug User Fee Act date, the FDA target action date for their decision, is in the third quarter of 2023. Thomas TriompheExecutive Vice President, Vaccines, SanofiThis is a landmark file acceptance in the US as it brings us one step closer to offering the first and only broadly protective option against RSV disease designed for all infants. Given the unprecedented number of otherwise healthy infants who have been hospitalized with RSV this year in the US and the recurrent pattern of RSV epidemics year after year, it is our intention to make nirsevimab available, if approved in time, for the 2023/2024 season to help alleviate the burden of RSV on families and the healthcare system. RSV is a very contagious virus that can lead to serious respiratory illness, according to the Centers for Disease Control and Prevention (CDC).10 In the US, RSV is the leading cause of hospitalisation for babies under one.11 Any infant can be hospitalized in their first RSV season: about 75% of infants hospitalized for RSV in the U.S. are born at term, with no underlying conditions.12-14 The current 2022/23 RSV season has placed a particularly high burden on infants and families in the United Stated with the American Academy of Pediatrics (AAP) requesting the White House declare an emergency to support the national response to the alarming surge of pediatric hospitalizations due to RSV and influenza. Dr William MullerAssociate Professor, Pediatrics, Northwestern University Feinberg School of Medicine and Scientific Director, Clinical and Community Trials, Ann & Robert H. Lurie Childrens Hospital of Chicago, Illinois"A substantial burden of disease from RSV affects infants, families, and healthcare providers every year. Effective interventions to prevent RSV are a critical need. This year in the US, weve seen first-hand how frightening the impact of this respiratory disease is on our patients and how stressful it is on the healthcare system, highlighting the urgency of addressing this problem." The submission was based on results from the Phase 3 MELODY, Phase 2/3 MEDLEY and Phase 2b trials.1-8 Results across the MELODY and Phase 2b trials showed that nirsevimab demonstrated consistent protection of approximately 80%, against medically attended RSV disease with a single dose.1-5 In these trials, nirsevimab helped protect an all-infant population (including healthy term, late preterm, and preterm infants, as well as infants with specific health conditions) against RSV disease requiring medical care, including physician office, urgent care, emergency room visits and hospitalizations, through the duration of the RSV season.1-8 The safety profile of nirsevimab was similar to placebo. Nirsevimab also demonstrated a comparable safety and tolerability profile to palivizumab in the Phase 2/3 MEDLEY trial.7-9 About nirsevimab In the U.S., nirsevimab is an investigational single-dose long-acting antibody designed to help protect all infants from birth through their first RSV season and for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season. Nirsevimab has been developed to offer newborns and infants direct RSV protection via an antibody to help prevent lower respiratory tract infection (LRTI) caused by RSV. Monoclonal antibodies do not require the activation of the immune system to help offer timely, rapid and direct protection against disease.15 In March 2017, Sanofi and AstraZeneca announced anagreementto develop and commercialize nirsevimab. Under the terms of the agreement, AstraZeneca leads all development and manufacturing activities and Sanofi leads commercialization activities and records revenues. Under the terms of the global agreement, Sanofi made an upfront payment of 120m, has paid a development milestone of 30m and will pay up to a further 465m upon achievement of certain development and sales-related milestones. The two companies share all costs and profits. Nirsevimab has been granted designations to facilitate expedited development by several regulatory agencies around the world. These include Breakthrough Therapy Designation by the China Center for Drug Evaluation under the National Medical Products Administration;Breakthrough Therapy Designationfrom the FDA; access granted to the European Medicines Agency (EMA)PRIority MEdicinesscheme; Promising Innovative Medicine designation by the UK Medicines and Healthcare products Regulatory Agency; and named a medicine for prioritized development under the Project for Drug Selection to Promote New Drug Development in Pediatrics by the Japan Agency for Medical Research and Development (AMED). Nirsevimab was approved by the European Commission in October 2022, and by the UK Medicines and Healthcare products Regulatory Agency (MHRA) in November 2022.16,17 About the clinical trials The Phase 2b trial was a randomized, placebo-controlled trial designed to measure the efficacy of nirsevimab against medically attended LRTI through 150 days post-dose. Healthy preterm infants of 29<35 weeks gestation (n= 1,453) were randomized (2:1) to receive a single 50mg intramuscular injection of nirsevimab (n= 969) or placebo (n= 484) at the RSV season start.3,4 The primary endpoint was met, significantly reducing the incidence of medically attended LRTI caused by RSV by 70.1% (95% CI: 52.3, 81.2) compared to placebo.3,4 The proposed dosing regimen was recommended based on further exploration of the Phase 2b data.3 When considering the dosing regimen recommended for approval in this study, nirsevimab reduced the incidence of medically attended LRTI caused by RSV by 86.2% (95% CI: 68.0, 94.0) in gestational age 29 to <35 weeks. 3,4 The subsequent Phase 3 study, MELODY, applied the recommended dosing regimen.1,2 The Phase 3 MELODY (primary cohort) trial was a randomized, placebo-controlled trial conducted across 21 countries designed to determine efficacy of nirsevimab against medically attended LRTI due to RSV confirmed by reverse transcriptase polymerase chain reaction testing through 150 days after dosing, versus placebo, in healthy late preterm and term infants (35 weeks gestational age or greater) entering their first RSV season.1,2The primary endpoint was met, significantly reducing the incidence of medically attended LRTI, such as bronchiolitis or pneumonia, caused by RSV compared to placebo.1,2 Infants were randomized (2:1) to receive a single 50mg (in infants weighing <5kg) or 100mg (in infants weighing 5kg) intramuscular injection of nirsevimab or placebo.1,2 Following the analysis of the initial 1,490 infants within the MELODY primary cohort additional infants continued to be enrolled. A total of 3,012 healthy late preterm and term infants (35 weeks gestational age or greater) entering their first RSV season were randomized to receive nirsevimab (n=2,009) or placebo (n=1,003). In the exploratory analysis, a single 50mg (in infants weighing <5kg) or 100mg (in infants weighing 5kg) intramuscular injection of nirsevimab reduced the incidence of medically attended LRTI caused by RSV through 150 days after dosing by 76.4% (95%: CI 62.3, 85.2) compared to placebo, with an acceptable safety profile. Further, nirsevimab demonstrated a 76.8% (95%: CI 49.4, 89.4) reduction in the risk of RSV LRTI with hospitalization through 150 days after dosing compared to placebo. MEDLEY was a Phase 2/3, randomized, double-blind, palivizumab-controlled trial with the primary objective of assessing safety and tolerability for nirsevimab in preterm infants and infants with congenital heart disease (CHD) and/or chronic lung disease of prematurity (CLD) eligible to receive palivizumab.7,8 Between July 2019 and May 2021, approximately 918 infants entering their first RSV season were randomized to receive a single 50mg (in infants weighing <5kg) or 100mg (in infants weighing 5kg) intramuscular injection of nirsevimab or palivizumab. Safety was assessed by monitoring the occurrence of treatment emergent adverse events (TEAEs) and treatment emergent severe adverse events (TESAEs) through 360 days post-dose.7,8 Serum levels of nirsevimab following dosing (on day 151) in this trial were comparable with those observed in the Phase 3 MELODY trial, indicating similar protection in this population to that in the healthy term and late preterm infants is likely.7 The safety profile of nirsevimab was similar to palivizumab in the MEDLEY Phase 2/3 and consistent with the safety profile in term and preterm infants studied in the MELODY Phase 3 trial compared to placebo.1-4,7,8 The most commonly reported adverse reactions were: rash 14 days post-dose, (the majority of which were mild to moderate); pyrexia (fever) within 7 days post-dose; non-serious injection site reactions within 7 days post-dose.16 Findings from the nirsevimab clinical trial program included a pre-specified pooled analysis of the Phase 3 MELODY trial (primary cohort) and the recommended dose from the Phase 2b trial, in which a relative risk reduction of 79.5% versus placebo (95% CI 65.9, 87.7; P<0.0001) was seen against medically attended LRTI, such as bronchiolitis or pneumonia, caused by RSV in infants born at term or preterm entering their first RSV season.5 This analysis also showed a relative risk reduction of 77.3% (95% CI 50.3, 89.7; P<0.001) against RSV LRTI hospitalizations.5 About RSV RSV is a very contagious virus that can lead to serious respiratory illness for infants, according to the Centers for Disease Control and Prevention (CDC).10 In the U.S., RSV is the leading cause of hospitalization in infants under 12 months.11 Approximately 75% of infants hospitalized for RSV are born at term with no underlying conditions.12-14 RSV symptoms can include runny nose, coughing, sneezing, fever, decrease in appetite, and wheezing.10 Each year RSV infection leads to approximately 500,000 emergency department visits by children under 5 years of age, which represents 1 in 4 of all RSV-related doctor visits, according to the CDC.18 About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Media RelationsSandrine Guendoul|+ 33 6 25 09 14 25 |sandrine.guendoul@sanofi.comSally Bain|+ 1 617 834 6026 |sally.bain@sanofi.comEvan Berland | + 1 215 432 0234 | evan.berland@sanofi.comKate Conway | + 1 508 364 4931 | kate.conway@sanofi.com Investor RelationsEva Schaefer-Jansen|+ 33 7 86 80 56 39 |eva.schaefer-jansen@sanofi.comArnaud Delepine|+ 33 6 73 69 36 93 | arnaud.delepine@sanofi.comCorentine Driancourt|+ 33 6 40 56 92 21 | corentine.driancourt@sanofi.comFelix Lauscher|+ 1908612 7239 | felix.lauscher@sanofi.comPriya Nanduri| + 1 617 764 6418 |priya.nanduri@sanofi.com Nathalie Pham|+ 33 7 85 93 30 17 | nathalie.pham@sanofi.com Sanofi Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words expects, anticipates, believes, intends, estimates, plans and similar expressions. Although Sanofis management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofis ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. Any material effect of COVID-19 on any of the foregoing could also adversely impact us. This situation is changing rapidly and additional impacts may arise of which we are not currently aware and may exacerbate other previously identified risks. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under Risk Factors and Cautionary Statement Regarding Forward-Looking Statements in Sanofis annual report on Form 20-F for the year ended December 31, 2021. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. Attachment Source: West Corporation Jan 04, 2023: Banco Santander Press Release: Availability of the Q4 2022 Memorandum for modelling purposes Availability of the Q4 Memorandum for modelling purposes Paris, France January 4, 2023 - Sanofi announced today that its Q4 2022 Memorandum for modelling purposes is available on the "Investors" page of the company's website: https://www.sanofi.com/en/investors/financial-results-and-events/financial-results/Q4-results-2022 As for each quarter, Sanofi prepared this document to assist in the financial modelling of the Group's quarterly results. This document includes a reminder on various non-comparable items and exclusivity losses as well as the foreign currency impact and share count. Sanofi's fourth-quarter 2022 results will be published on February 3, 2023. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Media RelationsSandrine Guendoul | + 33 6 25 09 14 25 | sandrine.guendoul@sanofi.comSally Bain | + 1 617 834 6026 | sally.bain@sanofi.comNicolas Obrist | + 33 06 77 21 27 55 | nicolas.obrist@sanofi.comVictor Rouault | + 33 06 70 93 71 40 | victor.rouault@sanofi.com Investor RelationsEva Schaefer-Jansen | + 33 7 86 80 56 39 | eva.schaefer-jansen@sanofi.comArnaud Delepine | + 33 06 73 69 36 93 | arnaud.delepine@sanofi.comCorentine Driancourt | + 33 06 40 56 92 | corentine.driancourt@sanofi.comFelix Lauscher | + 1 908 612 7239 | felix.lauscher@sanofi.comPriya Nanduri | + 1 617 764 6418 | priya.nanduri@sanofi.com Nathalie Pham | + 33 07 85 93 30 17 | nathalie.pham@sanofi.com Sanofi Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words expects, anticipates, believes, intends, estimates, plans and similar expressions. Although Sanofis management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofis ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. Any material effect of COVID-19 on any of the foregoing could also adversely impact us. This situation is changing rapidly and additional impacts may arise of which we are not currently aware and may exacerbate other previously identified risks. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under Risk Factors and Cautionary Statement Regarding Forward-Looking Statements in Sanofis annual report on Form 20-F for the year ended December 31, 2021. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. Attachment Source: West Corporation 2022 Dec 21, 2022: Banco Santander Press Release: Positive Dupixent (dupilumab) Phase 3 results in adults and adolescents with eosinophilic esophagitis published in the New England Journal of Medicine Positive Dupixent (dupilumab) Phase 3 results in adults and adolescents with eosinophilic esophagitis published in the New England Journal of Medicine Dupixent 300 mg weekly showed significant histological disease remission and improvement in symptoms of the disease compared to placeboImprovements were sustained for up to one year in patients aged 12 years and older with eosinophilic esophagitis (EoE)Dupixent is the first and only targeted medicine indicated in the U.S. to treat EoE patients aged 12 and older weighing at least 40 kg Paris and Tarrytown, N.Y. DECEMBER 21, 2022 The New England Journal of Medicine has published results from a positive Phase 3 trial showing adults and adolescents treated with Dupixent (dupilumab) 300 mg weekly experienced significant improvements in signs and symptoms of eosinophilic esophagitis (EoE), which were sustained for up to one year. EoE is a chronic, progressive inflammatory disease that damages the esophagus and prevents it from working properly. These data formed the basis for the U.S. Food and Drug Administration (FDA) approval of Dupixent in May 2022, making it the first and only medicine indicated to treat patients with EoE aged 12 years and older, weighing at least 40 kg. These Phase 3 data have been submitted to the European Medicines Agency (EMA) to support regulatory approval for adults and adolescents with EoE. The EMAs Committee for Medicinal Products for Human Use recently adopted a positive opinion recommending approval with a final decision expected in the coming months. Evan S. Dellon, M.D., M.P.H.Professor of Gastroenterology and Hepatology at the University of North Carolina School of Medicine The publication of these Phase 3 results in the New England Journal of Medicine reinforces the impact of the clinical trial data. These data showed dupilumab 300 mg weekly substantially decreased patient symptoms of difficulty swallowing, and led to histological disease remission and improvements in the endoscopic appearance of the esophagus, as compared to placebo. These data also underscore the role of inhibiting the IL-4 and IL-13 pathways in eosinophilic esophagitis with dupilumab, adding to our growing knowledge of this poorly understood disease. As published, patients received Dupixent 300 mg either weekly or every two weeks in the Phase 3 trial. Patients receiving Dupixent weekly experienced improvement in the ability to swallow and achieved histological disease remission. Additionally, these patients experienced improved anatomic, cellular, molecular and health-related quality of life measures, with improvements in signs and symptoms of EoE sustained for up to one year. Patients treated with Dupixent every two weeks experienced histological disease remission but did not experience improvement in the ability to swallow. The current FDA-approved dosage for Dupixent as a treatment for children and adults aged 12 years and older with EoE, weighing at least 40 kg, is 300 mg weekly. The safety results were generally consistent with the known safety profile of Dupixent in its approved indications. Adverse events (5%) that were more commonly observed with Dupixent included injection site reactions, nasopharyngitis and rash. About Eosinophilic Esophagitis EoE is a chronic, progressive inflammatory disease that damages the esophagus and prevents it from working properly. The results seen with Dupixent in adults and adolescents with EoE demonstrate that interleukin-4 (IL-4) and interleukin-13 (IL-13) are key and central drivers of the type 2 inflammation underlying this disease. For people with EoE, swallowing even small amounts of food can be a painful and worrisome choking experience. They are often left to contend with the frustration and anxiety of a constantly evolving list of foods to avoid, a poor quality of life and a higher risk of depression. In cases where EoE causes the esophagus to narrow, forced and potentially painful dilation (physical expansion) of the esophagus may be needed. In severe cases, a feeding tube may be the only option to ensure proper caloric intake and adequate nutrition. Of the approximately 209,000 patients aged 12 years and older living with EoE in the U.S. who are currently treated with therapies not specifically approved for the disease, about 42,000 continue to experience symptoms despite multiple treatments. About the Dupixent Eosinophilic Esophagitis Trial The Phase 3 randomized, double-blind, placebo-controlled trial evaluated the efficacy and safety of Dupixent in patients aged 12 years and older with EoE in three parts. Part A enrolled 81 patients and evaluated Dupixent 300 mg weekly for 24 weeks. Part B enrolled 240 patients and evaluated Dupixent 300 mg weekly and every two weeks for 24 weeks. Parts A and B were designed similarly and consisted of separate patient groups. All patients in Parts A and B had an option to participate in Part C for an additional 28 weeks, for up to 52 weeks of Dupixent treatment. Part C enrolled 77 patients from Part A. At 24 weeks, the co-primary endpoints in Parts A and B assessed patient-reported measures of difficulty swallowing and esophageal inflammation. The secondary endpoints included assessments of histopathologic measures of the severity and extent of additional histological measures in the esophagus, and other measures. In Part C, all primary and secondary endpoints assessed in Parts A and B were assessed as secondary endpoints at 52 weeks. About Dupixent Dupixent is a fully human monoclonal antibody that inhibits the signaling of the IL-4 and IL-13 pathways and is not an immunosuppressant. The Dupixent development program has shown significant clinical benefit and a decrease in type 2 inflammation in Phase 3 trials, establishing that IL-4 and IL-13 are key and central drivers of the type 2 inflammation that plays a major role in multiple related and often co-morbid diseases. These diseases include approved indications for Dupixent such as asthma, atopic dermatitis, chronic rhinosinusitis with nasal polyposis (CRSwNP), EoE and prurigo nodularis (PN). Dupixent has received regulatory approvals in one or more countries around the world for use in certain patients with atopic dermatitis, asthma, CRSwNP, EoE or PN in different age populations. Dupixent is currently approved across these indications in the U.S. and for one or more of these indications in more than 60 countries, including in the European Union and Japan. More than 500,000 patients have been treated with Dupixent globally. Dupilumab Development Program Dupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement. To date, dupilumab has been studied across more than 60 clinical trials involving more than 10,000 patients with various chronic diseases driven in part by type 2 inflammation. In addition to the currently approved indications, Sanofi and Regeneron are studying dupilumab in a broad range of diseases driven by type 2 inflammation or other allergic processes in Phase 3 trials, including pediatric EoE, hand and foot atopic dermatitis, chronic inducible urticaria-cold, chronic spontaneous urticaria, chronic pruritis of unknown origin, chronic obstructive pulmonary disease with evidence of type 2 inflammation, chronic rhinosinusitis without nasal polyposis, allergic fungal rhinosinusitis, allergic bronchopulmonary aspergillosis and bullous pemphigoid. These potential uses of dupilumab are currently under clinical investigation, and the safety and efficacy in these conditions have not been fully evaluated by any regulatory authority. About Regeneron Regeneron is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led for nearly 35 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, hematologic conditions, infectious diseases and rare diseases. Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite technologies, such as VelocImmune, which uses unique genetically humanized mice to produce optimized fully human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world. For more information, please visit www.Regeneron.com or follow @Regeneron on Twitter. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY. Sanofi Media RelationsSally Bain|+ 1 617 834 6026 |sally.bain@sanofi.com Sanofi Investor RelationsEva Schaefer-Jansen | + 33 7 86 80 56 39 | eva.schaefer-jansen@sanofi.com Arnaud Delepine | + 33 06 73 69 36 93 | arnaud.delepine@sanofi.com Corentine Driancourt | + 33 06 40 56 92 21 | corentine.driancourt@sanofi.com Felix Lauscher | + 1 908 612 7239 | felix.lauscher@sanofi.com Priya Nanduri | +1 617 764 6418 | priya.nanduri@sanofi.com Nathalie Pham | + 33 07 85 93 30 17 | nathalie.pham@sanofi.com Regeneron Media RelationsSharon Chen | + 1 914 847 1546 | sharon.chen@regeneron.com Regeneron Investor RelationsVesna Tosic | + 914 847 5443 | vesna.tosic@regeneron.com Sanofi Disclaimers or Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements are generally identified by the words "expects", "anticipates", "believes", "intends", "estimates", "plans" and similar expressions. Although Sanofi's management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. Any material effect of COVID-19 on any of the foregoing could also adversely impact us. This situation is changing rapidly and additional impacts may arise of which we are not currently aware and may exacerbate other previously identified risks. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in Sanofi's annual report on Form 20-F for the year ended December 31, 2021. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. Regeneron Forward-Looking Statements and Use of Digital Media This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. (Regeneron or the Company), and actual events or results may differ materially from these forward-looking statements. Words such as anticipate, expect, intend, plan, believe, seek, estimate, variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the impact of SARS-CoV-2 (the virus that has caused the COVID-19 pandemic) on Regenerons business and its employees, collaborators, and suppliers and other third parties on which Regeneron relies, Regenerons and its collaborators ability to continue to conduct research and clinical programs, Regenerons ability to manage its supply chain, net product sales of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, Regenerons Products), and the global economy; the nature, timing, and possible success and therapeutic applications of Regenerons Products and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, Regenerons Product Candidates) and research and clinical programs now underway or planned, including without limitation Dupixent (dupilumab) for the treatment of adults and adolescents with eosinophilic esophagitis (EoE); uncertainty of the utilization, market acceptance, and commercial success of Regenerons Products and Regenerons Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary), including the studies discussed or referenced in this press release, on any of the foregoing or any potential regulatory approval of Regenerons Products and Regenerons Product Candidates; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regenerons Product Candidates and new indications for Regenerons Products, such as Dupixent for the treatment of adults and adolescents with EoE based on the European Medicines Agency submission referenced in this press release, as well as for the treatment of pediatric EoE, hand and foot atopic dermatitis, chronic inducible urticaria-cold, chronic spontaneous urticaria, chronic pruritis of unknown origin, chronic obstructive pulmonary disease with evidence of type 2 inflammation, chronic rhinosinusitis without nasal polyposis, allergic fungal rhinosinusitis, allergic bronchopulmonary aspergillosis, bullous pemphigoidand, other potential indications; the ability of Regenerons collaborators, licensees, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regenerons Products and Regenerons Product Candidates; the ability of Regeneron to manage supply chains for multiple products and product candidates; safety issues resulting from the administration of Regenerons Products (such as Dupixent) and Regenerons Product Candidates in patients, including serious complications or side effects in connection with the use of Regenerons Products and Regenerons Product Candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict Regenerons ability to continue to develop or commercialize Regenerons Products and Regenerons Product Candidates, including without limitation Dupixent; ongoing regulatory obligations and oversight impacting Regenerons Products, research and clinical programs, and business, including those relating to patient privacy; the availability and extent of reimbursement of Regenerons Products from third-party payers, including private payer healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payers and new policies and procedures adopted by such payers; competing drugs and product candidates that may be superior to, or more cost effective than, Regenerons Products and Regenerons Product Candidates; the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators or licensees may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license, collaboration, or supply agreement, including Regenerons agreements with Sanofi and Bayer (or their respective affiliated companies, as applicable) to be cancelled or terminated; and risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA (aflibercept) Injection, Praluent (alirocumab), and REGEN-COV (casirivimab and imdevimab)), other litigation and other proceedings and government investigations relating to the Company and/or its operations, the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regenerons business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regenerons filings with the U.S. Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2021 and its Form 10-Q for the quarterly period ended September 30, 2022. Any forward-looking statements are made based on managements current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise. Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regenerons media and investor relations website (http://newsroom.regeneron.com) and its Twitter feed (http://twitter.com/regeneron). Attachment Source: West Corporation Dec 19, 2022: Banco Santander Press Release: Sanofi and Innate Pharma expand collaboration for natural killer cell therapeutics in oncology Sanofi and Innate Pharma expand collaboration for natural killer cell therapeutics in oncology Sanofi gains exclusive license to Innates B7H3 ANKETTM program and options for two additional targets; Upon candidate selection, Sanofi will be responsible for all development, manufacturing and commercialization Paris, December 19, 2022 Sanofi (NASDAQ: SNY) and Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) announced today an expansion of their collaboration, with Sanofi licensing a natural killer (NK) cell engager program targeting B7H3 from Innates ANKETTM (Antibody-based NK Cell Engager Therapeutics) platform. Sanofi will also have the option to add up to two additional ANKETTM targets. Upon candidate selection, Sanofi will be responsible for all development, manufacturing and commercialization. Innate and Sanofi signed a first NK cell engagers collaboration in 2016 for the generation and evaluation of up to two bispecific NK cell engagers, which are currently being evaluated by Sanofis R&D team, with one of these molecules already in clinical studies..Valeria Fantin, Ph.D. Global Head of Oncology Research at SanofiAt Sanofi, we are exploring the potential of NK cells for cancer immunotherapy, a key pillar for our oncology strategy. Our relationship with Innate aligns with our commitment to work with promising French companies and supports our ambition to develop a diverse portfolio of next-generation NK cell engagers, highly synergistic with Sanofis allogeneic NK cell platform, engineered lymphokines that stimulate NK cells, and growing Immuno-oncology pipeline. As a leading global company with roots in France, we are proud to collaborate to support the French healthcare ecosystem." Yannis Morel, Ph.D. Executive Vice President, Product portfolio strategy & Business development at Innate PharmaBuilding on the success of our existing collaboration on hematologic targets, we are pleased to expand and strengthen our partnership with Sanofi on NK Cell Engagers with the addition of up to three new programs, including in solid tumors. Sanofis investment in Innate further validate the value of our ANKETTM platform and its potential to address multiple tumor types. By incorporating various tumor antigen binders, NK Cell Engagers are a versatile technology that may provide new options for patients and offer clinical benefit across multiple cancers, whilst also maintaining a good safety profile. This agreement also highlights Innates strategy to build a broad portfolio of ANKET programs addressing different types of cancer. Under the terms of the new license agreement, Innate will receive 25m upfront payment and up to 1.35bn total in preclinical, clinical, regulatory and commercial milestones plus royalties on potential net sales. Closing of the transaction is subject to HSR approval. About 2016 Sanofi/Innate research collaboration and licensing agreementIn 2016, Sanofi and Innate entered into a research collaboration and licensing agreement for the generation and evaluation of up to two bispecific NK cell engagers, using technology from Innate Pharma and Sanofis proprietary bispecific antibody format as well as tumor targets. A Phase 1/2 clinical trial by Sanofi is ongoing, evaluating IPH6101/SAR579 (SAR443579), the first NKp46/CD16-based CD123-targeted ANKETTM NK cell engager, in patients with relapsed or refractory acute myeloid leukemia (R/R AML), B-cell acute lymphoblastic leukemia (B-ALL) or high-risk myelodysplastic syndrome (HR-MDS). In the summer 2022, Sanofi had made the decision to progress IPH6401/SAR514 (SAR445514) into investigational new drug (IND)-enabling studies. IPH6401/SAR514 is a BCMA-targeting NK cell engager using Sanofis proprietary CROSSODILE multi-functional platform, which comprises the Cross-Over-Dual-Variable-Domain (CODV) format. It induces a dual targeting of the NK activating receptors, NKp46 and CD16, for an optimized NK cell activation, based on Innates ANKETTM proprietary platform. Under the terms of the original license agreement, Sanofi is responsible for the development, manufacturing and commercialization of products resulting from the research collaboration. Innate Pharma will be eligible to up to 400m in development and commercial milestone payments as well as royalties on net sales. To date, 13m milestone payments to Innate have been announced. About Sanofis approach to NK therapies in oncologyAt Sanofi, we are exploring the intrinsic abilities of Natural Killer cells to create new immunotherapies for patients with cancer. Natural Killer cell-based therapies are a key pillar within Sanofis Oncology strategy. By activating the innate power of NK cells, Sanofi is advancing a diverse and complementary range of NK-based therapeutics to transform immune biology. The breadth of our modalities and unique strength to innovate end-to-end maximizes the therapeutic possibilities for more people with cancer. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY About Innate PharmaInnate Pharma S.A. is a global, clinical-stage oncology-focused biotech company dedicated to improving treatment and clinical outcomes for patients through therapeutic antibodies that harness the immune system to fight cancer. Innate Pharmas broad pipeline of antibodies includes several potentially first-in-class clinical and preclinical candidates in cancers with high unmet medical need. Innate is a pioneer in the understanding of Natural Killer cell biology and has expanded its expertise in the tumor microenvironment and tumor-antigens, as well as antibody engineering. This innovative approach has resulted in a diversified proprietary portfolio and major alliances with leaders in the biopharmaceutical industry including Bristol-Myers Squibb, Novo Nordisk A/S, Sanofi, and a multi-products collaboration with AstraZeneca. Headquartered in Marseille, France with a US office in Rockville, MD, Innate Pharma is listed on Euronext Paris and Nasdaq in the US. Learn more about Innate Pharma at www.innate-pharma.com SanofiMedia RelationsSandrine Guendoul | + 33 6 25 09 14 25 | sandrine.guendoul@sanofi.comChrystel Baude|+ 33 6 70 98 70 59 |chrystel.baude@sanofi.comSally Bain|+ 1 617 834 6026 |sally.bain@sanofi.comKate Conway|+ 1508 364 4931 |kate.conway@sanofi.com Investor RelationsEva Schaefer-Jansen|+ 33 7 86 80 56 39 |eva.schaefer-jansen@sanofi.comArnaud Delepine|+ 33 6 73 69 36 93 | arnaud.delepine@sanofi.comCorentine Driancourt|+ 33 6 40 56 92 21 | corentine.driancourt@sanofi.comFelix Lauscher|+ 1908612 7239 | felix.lauscher@sanofi.comPriya Nanduri| +1 617 764 6418 |priya.nanduri@sanofi.com Nathalie Pham|+ 33 7 85 93 30 17 | nathalie.pham@sanofi.com Innate PharmaMedia Arthur Rouille | +33 1 44 71 00 15 | innate@newcap.euInvestors Henry Wheeler | +33(0)4 84 90 32 88 | henry.wheeler@innate-pharma.fr Sanofi Forward-Looking Statements This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are identified by the words "expects", "anticipates", "believes", "intends", "estimates", "plans" and similar expressions. Although Sanofi's management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofi's ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. Any material effect of COVID-19 on any of the foregoing could also adversely impact us. This situation is changing rapidly and additional impacts may arise of which we are not currently aware and may exacerbate other previously identified risks. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in Sanofi's annual report on Form 20-F for the year ended December 31, 2021. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. Attachment Source: West Corporation Dec 16, 2022: Banco Santander Press Release: Dupixent (dupilumab) recommended for EU approval by the CHMP for the treatment of eosinophilic esophagitis Dupixent (dupilumab) recommended for EU approval by the CHMP for the treatment of eosinophilic esophagitis If approved, Dupixent would be the first and only targeted medicine specifically indicated for people aged 12 years and older with eosinophilic esophagitis in the European UnionIn the U.S., Dupixent is currently the only medicine indicated to treat eosinophilic esophagitisApproval recommendation based on pivotal trial data demonstrating patients on Dupixent 300 mg weekly experienced significantly improved ability to swallow and achieved histological disease remission compared to placeboIn the European Union, about 50,000 adults and adolescents live with severe uncontrolled eosinophilic esophagitis Paris and Tarrytown, N.Y. DECEMBER 16, 2022 The European Medicines Agencys Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending the approval of Dupixent (dupilumab) in the European Union (EU) to treat adults and adolescents with eosinophilic esophagitis (EoE). This positive opinion covers those who are 12 years and older, weighing at least 40 kg, and inadequately controlled by, are intolerant to or who are not candidates for conventional medicinal therapy. The European Commission is expected to announce a final decision on the Dupixent application in the coming months. In May 2022, Dupixent 300 mg weekly was approved by the U.S. Food and Drug Administration for the treatment of patients aged 12 years and older, weighing at least 40 kg. EoE is a chronic, progressive inflammatory disease that damages the esophagus and prevents it from working properly. The results seen with Dupixent in adults and adolescents with EoE demonstrate that interleukin-4 (IL-4) and interleukin-13 (IL-13) are key and central drivers of the type 2 inflammation underlying this disease. For people with EoE, swallowing even small amounts of food can be a painful and worrisome choking experience. They are often left to contend with the frustration and anxiety of a constantly evolving list of foods to avoid, a poor quality of life and a higher risk of depression. In cases where EoE causes the esophagus to narrow, forced and potentially painful dilation (physical expansion) of the esophagus may be needed. In severe cases, a feeding tube may be the only option to ensure proper caloric intake and adequate nutrition. The positive CHMP opinion is supported by 52-week data from a Phase 3 trial consisting of three parts Part A and Part B investigated Dupixent 300 mg weekly compared to placebo for 24 weeks, and Part C observed patients from Parts A and B, all of whom were on Dupixent, having continued on or switched to Dupixent for an additional 28 weeks. The results demonstrated Dupixent-treated patients experienced improvements in their ability to swallow as early as four weeks, as well as histological disease remission, improvements in abnormal endoscopic findings of the esophagus and cellular improvements at 24 weeks compared to placebo, with outcomes maintained up to one year. The safety results of the trial were generally consistent with the known safety profile of Dupixent in its approved indications. Adverse events more commonly observed with Dupixent compared to placebo included infections. The use of Dupixent in adults and adolescents with EoE is investigational in the EU and is not yet approved. About Dupixent Dupixent is a fully human monoclonal antibody that inhibits the signaling of the IL-4 and IL-13 pathways and is not an immunosuppressant. The Dupixent development program has shown significant clinical benefit and a decrease in type 2 inflammation in Phase 3 trials, establishing that IL-4 and IL-13 are key and central drivers of the type 2 inflammation that plays a major role in multiple related and often co-morbid diseases. These diseases include approved indications for Dupixent, such as atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP) and prurigo nodularis, as well as investigational diseases such as EoE in the EU. Dupixent has received regulatory approvals in one or more countries around the world for use in certain patients with atopic dermatitis, asthma, CRSwNP, EoE or prurigo nodularis in different age populations. Dupixent is currently approved for one or more of these indications in more than 60 countries, including in Europe, the U.S. and Japan. More than 500,000 patients have been treated with Dupixent globally. Dupilumab Development Program Dupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement. To date, dupilumab has been studied across more than 60 clinical trials involving more than 10,000 patients with various chronic diseases driven in part by type 2 inflammation. In addition to the currently approved indications, Sanofi and Regeneron are studying dupilumab in a broad range of diseases driven by type 2 inflammation or other allergic processes in Phase 3 trials, including pediatric EoE, hand and foot atopic dermatitis, chronic inducible urticaria-cold, chronic spontaneous urticaria, chronic pruritus of unknown origin, chronic obstructive pulmonary disease with evidence of type 2 inflammation, chronic rhinosinusitis without nasal polyposis, allergic fungal rhinosinusitis, allergic bronchopulmonary aspergillosis and bullous pemphigoid. These potential uses of dupilumab are currently under clinical investigation, and the safety and efficacy in these conditions have not been fully evaluated by any regulatory authority. About Regeneron Regeneron is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led for nearly 35 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, hematologic conditions, infectious diseases and rare diseases. Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite technologies, such as VelocImmune, which uses unique genetically humanized mice to produce optimized fully human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world. For more information, please visit www.Regeneron.com or follow @Regeneron on Twitter. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY. Sanofi Media RelationsSally Bain|+ 1 617 834 6026 |sally.bain@sanofi.com Sanofi Investor RelationsEva Schaefer-Jansen | + 33 7 86 80 56 39 | eva.schaefer-jansen@sanofi.comArnaud Delepine | + 33 06 73 69 36 93 | arnaud.delepine@sanofi.comCorentine Driancourt | + 33 06 40 56 92 21 | corentine.driancourt@sanofi.comFelix Lauscher | + 1 908 612 7239 | felix.lauscher@sanofi.comPriya Nanduri |+ 1 617 764 6418 | priya.nanduri@sanofi.comNathalie Pham | + 33 07 85 93 30 17 | nathalie.pham@sanofi.com Regeneron Media RelationsSharon Chen | + 1 914 847 1546| Sharon.Chen@regeneron.com Regeneron Investor RelationsVesna Tosic | + 914 847 5443 | vesna.tosic@regeneron.com Sanofi Disclaimers or Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements are generally identified by the words "expects", "anticipates", "believes", "intends", "estimates", "plans" and similar expressions. Although Sanofi's management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. Any material effect of COVID-19 on any of the foregoing could also adversely impact us. This situation is changing rapidly and additional impacts may arise of which we are not currently aware and may exacerbate other previously identified risks. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in Sanofi's annual report on Form 20-F for the year ended December 31, 2021. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. Regeneron Forward-Looking Statements and Use of Digital Media This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. (Regeneron or the Company), and actual events or results may differ materially from these forward-looking statements. Words such as anticipate, expect, intend, plan, believe, seek, estimate, variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the impact of SARS-CoV-2 (the virus that has caused the COVID-19 pandemic) on Regenerons business and its employees, collaborators, and suppliers and other third parties on which Regeneron relies, Regenerons and its collaborators ability to continue to conduct research and clinical programs, Regenerons ability to manage its supply chain, net product sales of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, Regenerons Products), and the global economy; the nature, timing, and possible success and therapeutic applications of Regenerons Products and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, Regenerons Product Candidates) and research and clinical programs now underway or planned, including without limitation Dupixent (dupilumab); the impact of the opinion adopted by the European Medicines Agency's Committee for Medicinal Products for Human Use discussed in this press release on the potential approval by the European Commission of Dupixent for the treatment of adults and adolescents with eosinophilic esophagitis (EoE); uncertainty of the utilization, market acceptance, and commercial success of Regenerons Products and Regenerons Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary), including the studies discussed or referenced in this press release, on any of the foregoing or any potential regulatory approval of Regenerons Products and Regenerons Product Candidates; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regenerons Product Candidates and new indications for Regenerons Products, such as Dupixent for the treatment of pediatric EoE, hand and foot atopic dermatitis, chronic inducible urticaria-cold, chronic spontaneous urticaria, chronic pruritus of unknown origin, chronic obstructive pulmonary disease with evidence of type 2 inflammation, chronic rhinosinusitis without nasal polyposis, allergic fungal rhinosinusitis, allergic bronchopulmonary aspergillosis, bullous pemphigoid, other potential indications; the ability of Regenerons collaborators, licensees, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regenerons Products and Regenerons Product Candidates; the ability of Regeneron to manage supply chains for multiple products and product candidates; safety issues resulting from the administration of Regenerons Products (such as Dupixent) and Regenerons Product Candidates in patients, including serious complications or side effects in connection with the use of Regenerons Products and Regenerons Product Candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict Regenerons ability to continue to develop or commercialize Regenerons Products and Regenerons Product Candidates, including without limitation Dupixent; ongoing regulatory obligations and oversight impacting Regenerons Products, research and clinical programs, and business, including those relating to patient privacy; the availability and extent of reimbursement of Regenerons Products from third-party payers, including private payer healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payers and new policies and procedures adopted by such payers; competing drugs and product candidates that may be superior to, or more cost effective than, Regenerons Products and Regenerons Product Candidates; the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators or licensees may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license, collaboration, or supply agreement, including Regenerons agreements with Sanofi and Bayer (or their respective affiliated companies, as applicable) to be cancelled or terminated; and risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA (aflibercept) Injection, Praluent (alirocumab), and REGEN-COV (casirivimab and imdevimab)), other litigation and other proceedings and government investigations relating to the Company and/or its operations, the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regenerons business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regenerons filings with the U.S. Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2021 and its Form 10-Q for the quarterly period ended September 30, 2022. Any forward-looking statements are made based on managements current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise. Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regenerons media and investor relations website (http://newsroom.regeneron.com) and its Twitter feed (http://twitter.com/regeneron). Attachment Source: West Corporation Dec 15, 2022: Banco Santander Press Release: Dupixent (dupilumab) approved by European Commission as the first and only targeted medicine indicated for prurigo nodularis Dupixent (dupilumab) approved by European Commission as the first and only targeted medicine indicated for prurigo nodularis Approval based on direct-to-Phase 3 program showing more than three times as many Dupixent patients experienced a clinically meaningful reduction in itch at 24 weeksDupixent also significantly reduced skin lesions and improved health-related quality of life compared to placebo In Europe, about 70,000 adults living with prurigo nodularis are most in need of new treatment optionsDupixent now approved to treat four chronic inflammatory diseases in the EU Paris and Tarrytown, N.Y. Dec. 15, 2022 The European Commission (EC) has expanded the marketing authorization for Dupixent(dupilumab) in the European Union to treat adults with moderate-to-severe prurigo nodularis who are candidates for systemic therapy. Prurigo nodularis is a chronic, debilitating skin disease with underlying type 2 inflammation and its impact on quality of life is one of the highest among inflammatory skin diseases. With this approval, Dupixent is the first and only targeted medicine specifically indicated to treat prurigo nodularis in Europe and the U.S. Naimish Patel,M.D. HeadofGlobal Development, Immunology and Inflammation atSanofi"As the first and only targeted medicine approved to treat people living with prurigo nodularis, Dupixent has the potential to transform the standard-of-care for people in Europe living with this debilitating skin disease. In the pivotal trials, patients treated with Dupixent experienced significant improvements in key hallmarks of the disease, such as reduction in itch and achieving clearer skin, as well as broader impacts on their daily lives. This approval of Dupixent underscores our continued commitment to bringing Dupixent to patients suffering from chronic skin diseases with underlying type 2 inflammation as quickly as possible." George D. Yancopoulos, M.D., Ph.D.President and Chief Scientific Officer at Regeneron"For the first time, patients with prurigo nodularis in Europe have a medicine that can help relieve the burden of itchy and painful nodules covering their skin, which can have a devastating impact on their day-to-day lives, both physically and mentally. Dupixent is now approved for its second dermatological disease and fourth disease overall. We remain committed to further investigating this innovative medicine for diseases such as chronic urticarias and chronic obstructive pulmonary disease in which type 2 inflammation may play a role." The EC decision is based on data from two Phase 3 trials, PRIME and PRIME2, evaluating the efficacy and safety of Dupixent (PRIME n=75; PRIME2 n=78) in adults with uncontrolled prurigo nodularis compared to placebo (PRIME n=76; PRIME2 n=82). In these trials, respectively, 44% and 37% of Dupixent patients experienced a clinically meaningful reduction in itch at 12 weeks, compared to 16% and 22% for placebo. The improvement further increased at 24 weeks, with approximately three times as many Dupixent patients (60% and 58%) experiencing a clinically meaningful reduction in itch from baseline, compared to placebo (18% and 20%). In PRIME and PRIME2, more than twice as many Dupixent patients (48% and 45%) also achieved clear or almost clear skin at 24 weeks, compared to placebo (18% and 16%). Dupixent also significantly improved health-related quality of life, while reducing measures of skin pain and symptoms of anxiety/depression from baseline at 24 weeks compared to placebo. The safety results of the trials were generally consistent with the known safety profile of Dupixent in its approved indications, with the most common side effects across indications including injection site reactions, conjunctivitis, conjunctivitis allergic, arthralgia, oral herpes, and eosinophilia. Adverse events more commonly observed in PN with Dupixent compared to placebo included conjunctivitis (4% vs. 1%). Dupixent was granted an additional one-year marketing protection in the EU based on recommendation by the CHMP that the medicine brings significant clinical benefit compared to existing therapies for patients with prurigo nodularis. About Prurigo Nodularis Prurigo nodularis is a chronic, debilitating skin disease with underlying type 2 inflammation and has one of the highest impacts on a patients quality of life among all inflammatory skin diseases dues to the extreme itch it causes. Those with prurigo nodularis experience intense, persistent itch with thick skin lesions (called nodules) that can cover most of the body. The disease is often painful, with burning, stinging and tingling of the skin and can negatively affect mental health, activities of daily living and social interactions. High-potency topical steroids are commonly prescribed but are associated with safety risks if used long-term. In Europe, about 70,000 adults living with prurigo nodularis are most in need of new treatment options. About the Dupixent Prurigo Nodularis Trials The PRIME and PRIME2 Phase 3 double-blind, placebo-controlled trials evaluated the efficacy and safety of Dupixent in 311 adults with uncontrolled prurigo nodularis. In PRIME and PRIME2, the primary endpoint evaluated the proportion of patients with clinically meaningful improvement in itch from baseline (measured by a 4-point reduction in Worst-Itch Numeric Rating Scale [WI-NRS] on a 0-10 scale) at 24 and 12 weeks, respectively. Additional endpoints included the proportion of patients with clear or almost clear skin of nodules at 24 weeks (measured by a score of 0 or 1 on the Investigator's Global Assessment PN-Stage [IGA PN-S] on a 0-4 scale), the proportion of patients who achieved a clinically meaningful response in both WI-NRS and IGA PN-S, improvement from baseline in health-related quality of life (measured by the Dermatology Life Quality Index [DLQI] on a 0-30 scale), improvement from baseline in skin pain (measured by a Numerical Rating Scale from 0-10), and improvement from baseline in symptoms of anxiety and depression (measured by the Hospital Anxiety and Depression Scale [HADS] from 0-42). About Dupixent Dupixent is an injection under the skin (subcutaneous injection) at different injection sites. In the EU for adults with prurigo nodularis, Dupixent is administered at 300 mg every two weeks, following a loading dose. It is available as both a pre-filled pen and pre-filled syringe at the 300 mg dose. Dupixent is intended for use under the guidance of a healthcare professional and can be given in a clinic or at home by self-administration after training by a healthcare professional. Dupixent is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not an immunosuppressant. The Dupixent development program has shown significant clinical benefit and a decrease in type 2 inflammation in Phase 3 trials, establishing that IL-4 and IL-13 are key and central drivers of the type 2 inflammation that plays a major role in multiple related and often co-morbid diseases. These diseases include approved indications for Dupixent, such as atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP) and prurigo nodularis, as well as investigational disease eosinophilic esophagitis (EoE) in the EU. Dupixent has received regulatory approvals in one or more countries around the world for use in certain patients with atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), eosinophilic esophagitis (EoE) or prurigo nodularis in different age populations. Dupixent is currently approved for one or more of these indications in more than 60 countries, including in Europe, the U.S. and Japan. More than 500,000 patients have been treated with Dupixent globally. Dupilumab Development Program Dupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement. To date, dupilumab has been studied across more than 60 clinical trials involving more than 10,000 patients with various chronic diseases driven in part by type 2 inflammation. In addition to the currently approved indications, Sanofi and Regeneron are studying dupilumab in a broad range of diseases driven by type 2 inflammation or other allergic processes in Phase 3 trials, including pediatric EoE, hand and foot atopic dermatitis, chronic inducible urticaria-cold, chronic spontaneous urticaria, chronic pruritus of unknown origin, chronic obstructive pulmonary disease with evidence of type 2 inflammation, chronic rhinosinusitis without nasal polyposis, allergic fungal rhinosinusitis, allergic bronchopulmonary aspergillosis and bullous pemphigoid. These potential uses of dupilumab are currently under clinical investigation, and the safety and efficacy in these conditions have not been fully evaluated by any regulatory authority. About Regeneron Regeneron is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led for nearly 35 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, hematologic conditions, infectious diseases and rare diseases. Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite technologies, such as VelocImmune, which uses unique genetically humanized mice to produce optimized fully human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world. For more information, please visit www.Regeneron.com or follow @Regeneron on Twitter. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY. Sanofi Media RelationsSally Bain|+ 1 617 834 6026 |sally.bain@sanofi.com Sanofi Investor RelationsEva Schaefer-Jansen | + 33 7 86 80 56 39 | eva.schaefer-jansen@sanofi.com Arnaud Delepine | + 33 06 73 69 36 93 | arnaud.delepine@sanofi.com Corentine Driancourt | + 33 06 40 56 92 | corentine.driancourt@sanofi.com Felix Lauscher | + 1 908 612 7239 | felix.lauscher@sanofi.com Priya Nanduri |+617 764 6418 | priya.nanduri@sanofi.com Nathalie Pham | + 33 07 85 93 30 17 | nathalie.pham@sanofi.com Regeneron Media RelationsSharon Chen | + 1 914 847 1546 | sharon.chen@regeneron.com Regeneron Investor RelationsVesna Tosic | + 914 847 5443 | vesna.tosic@regeneron.com Sanofi Disclaimers or Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements are generally identified by the words "expects", "anticipates", "believes", "intends", "estimates", "plans" and similar expressions. Although Sanofi's management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. Any material effect of COVID-19 on any of the foregoing could also adversely impact us. This situation is changing rapidly and additional impacts may arise of which we are not currently aware and may exacerbate other previously identified risks. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in Sanofi's annual report on Form 20-F for the year ended December 31, 2021. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. Regeneron Forward-Looking Statements and Use of Digital Media This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance ofRegeneron Pharmaceuticals, Inc.(Regeneron or the Company), and actual events or results may differ materially from these forward-looking statements. Words such as anticipate, expect, intend, plan, believe, seek, estimate, variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the impact of SARS-CoV-2 (the virus that has caused the COVID-19 pandemic) on Regenerons business and its employees, collaborators, and suppliers and other third parties on which Regeneron relies, Regenerons and its collaborators ability to continue to conduct research and clinical programs, Regenerons ability to manage its supply chain, net product sales of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, Regenerons Products), and the global economy; the nature, timing, and possible success and therapeutic applications of Regenerons Products and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, Regenerons Product Candidates) and research and clinical programs now underway or planned, including without limitation Dupixent (dupilumab) for the treatment of adults with moderate-to-severe prurigo nodularis who are candidates for systemic therapy; uncertainty of the utilization, market acceptance, and commercial success of Regenerons Products and Regenerons Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary), including the studies discussed or referenced in this press release, on any of the foregoing or any potential regulatory approval of Regenerons Products and Regenerons Product Candidates; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regenerons Product Candidates and new indications for Regenerons Products, such asDupixent for the treatment of pediatric eosinophilic esophagitis, hand and foot atopic dermatitis, chronic inducible urticaria-cold, chronic spontaneous urticaria, chronic pruritis of unknown origin, chronic obstructive pulmonary disease with evidence of type 2 inflammation, chronic rhinosinusitis without nasal polyposis, allergic fungal rhinosinusitis, allergic bronchopulmonary aspergillosis, bullous pemphigoidand, and other potential indications; the ability of Regenerons collaborators, licensees, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regenerons Products and Regenerons Product Candidates; the ability of Regeneron to manage supply chains for multiple products and product candidates; safety issues resulting from the administration of Regenerons Products (such as Dupixent) and Regenerons Product Candidates in patients, including serious complications or side effects in connection with the use of Regenerons Products and Regenerons Product Candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict Regenerons ability to continue to develop or commercialize Regenerons Products and Regenerons Product Candidates, including without limitation Dupixent; ongoing regulatory obligations and oversight impacting Regenerons Products, research and clinical programs, and business, including those relating to patient privacy; the availability and extent of reimbursement of Regenerons Products from third-party payers, including private payer healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payers and new policies and procedures adopted by such payers; competing drugs and product candidates that may be superior to, or more cost effective than, Regenerons Products and Regenerons Product Candidates; the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators or licensees may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license, collaboration, or supply agreement, including Regenerons agreements with Sanofi and Bayer (or their respective affiliated companies, as applicable) to be cancelled or terminated; and risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA(aflibercept) Injection, Praluent(alirocumab), and REGEN-COV (casirivimab and imdevimab)), other litigation and other proceedings and government investigations relating to the Company and/or its operations, the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regenerons business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regenerons filings with theU.S. Securities and Exchange Commission, including its Form 10-K for the year endedDecember 31, 2021 and its Form 10-Q for the quarterly period ended September 30, 2022. Any forward-looking statements are made based on managements current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise. Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regenerons media and investor relations website (http://newsroom.regeneron.com) and its Twitter feed (http://twitter.com/regeneron). Attachment Source: West Corporation Dec 11, 2022: Banco Santander Press Release: Statement from Sanofi regarding Horizon Therapeutics plc (Horizon) NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN WHOLE OR IN PART IN, INTO OR FROM ANY JURISDICTION WHERE TO DO SO WOULD CONSTITUTE A VIOLATION OF THE RELEVANT LAWS OR REGULATIONS OF THAT JURISDICTION.THIS IS AN ANNOUNCEMENT FALLING UNDER RULE 2.8 OF THE IRISH TAKEOVER PANEL ACT, 1997, TAKEOVER RULES, 2022 (THE TAKEOVER RULES). THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION. Statement from Sanofi regarding Horizon Therapeutics plc (Horizon) Paris, December 11, 2022. Sanofi S.A. (Sanofi) regularly evaluates a wide variety of business development opportunities and this has included the evaluation of a possible transaction involving Horizon. As transaction price expectations do not meet our value creation criteria, Sanofi announces it is no longer in discussions with Horizon and it does not intend to make an offer for Horizon.This announcement is intended to be treated as a statement to which Rule 2.8 of the Takeover Rules applies. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Media RelationsSandrine Guendoul|+ 33 6 25 09 14 25 |sandrine.guendoul@sanofi.comEvan Berland | +1 215 432 0234 | evan.berland@sanofi.comNicolas Obrist|+ 33 6 77 21 27 55 |nicolas.obrist@sanofi.comVictor Rouault|+ 33 6 70 93 71 40 |victor.rouault@sanofi.com Investor RelationsEva Schaefer-Jansen|+ 33 7 86 80 56 39 |eva.schaefer-jansen@sanofi.comArnaud Delepine|+ 33 6 73 69 36 93 | arnaud.delepine@sanofi.comCorentine Driancourt|+ 33 6 40 56 92 21 | corentine.driancourt@sanofi.comFelix Lauscher|+ 1908612 7239 | felix.lauscher@sanofi.comPriya Nanduri| + 1 617 764 6418 |priya.nanduri@sanofi.com Nathalie Pham|+ 33 7 85 93 30 17 | nathalie.pham@sanofi.com Sanofi Forward-Looking StatementsThe directors of Sanofi accept responsibility for the information contained in this announcement. To the best of their knowledge and belief (having taken all reasonable care to ensure such is the case), the information contained in this announcement is in accordance with the facts and does not omit anything likely to affect the import of such information. Attachment Press_Release Source: West Corporation Dec 02, 2022: Banco Santander Press Release: Statement from Sanofi regarding: rule 2.12 of the takeover rules THIS IS AN ANNOUNCEMENT FALLING UNDER RULE 2.12 OF THE IRISH TAKEOVER PANEL ACT, 1997, TAKEOVER RULES, 2022 (THE "TAKEOVER RULES"). NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN WHOLE OR IN PART IN, INTO OR FROM ANY JURISDICTION WHERE TO DO SO WOULD CONSTITUTE A VIOLATION OF THE RELEVANT LAWS OR REGULATIONS OF THAT JURISDICTION. DECEMBER 2, 2022 Statement from Sanofi regarding: rule 2.12 of the takeover rules Paris, December 2, 2022. As required by Rule 2.12 of the Takeover Rules, Sanofi S.A. (Sanofi) confirms that any offer for Horizon Therapeutics plc, if made by Sanofi, will be solely in cash. There is no certainty that any offer will be made, nor as to the terms on which any such offer may be made, if forthcoming. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Media RelationsSandrine Guendoul|+ 33 6 25 09 14 25 |sandrine.guendoul@sanofi.comSally Bain|+ 1 617 834 6026 |sally.bain@sanofi.comNicolas Obrist|+ 33 6 77 21 27 55 |nicolas.obrist@sanofi.comVictor Rouault|+ 33 6 70 93 71 40 |victor.rouault@sanofi.com Investor RelationsEva Schaefer-Jansen|+ 33 7 86 80 56 39 |eva.schaefer-jansen@sanofi.comFelix Lauscher|+ 1908612 7239 | felix.lauscher@sanofi.com Responsibility Statement and Disclaimers The directors of Sanofi accept responsibility for the information contained in this announcement. To the best of their knowledge and belief (having taken all reasonable care to ensure such is the case), the information contained in this announcement is in accordance with the facts and does not omit anything likely to affect the import of such information. Centerview Partners UK LLP, which is authorised and regulated by the Financial Conduct Authority in the United Kingdom (Centerview), is acting exclusively as financial adviser to Sanofi and no one else in connection with the matters referred to in this announcement and will not be responsible to anyone other than Sanofi for providing the protections afforded to clients of Centerview nor for providing advice in connection with the contents of this announcement or any matter or arrangement referred to herein. Neither Centerview nor any of its affiliates owes or accepts any duty, liability or responsibility whatsoever (whether direct or indirect, whether in contract, in tort, under statute or otherwise) to any person who is not a client of Centerview in connection with this announcement, any statement contained herein or otherwise. Goldman Sachs Bank Europe SE, Succursale de Paris (GSBE), which is authorised and regulated by the European Central Bank and the Federal Financial Supervisory Authority (Die Bundesanstalt fur Finanzdienstleistungsaufsicht) and Deutsche Bundesbank in Germany, is acting exclusively for Sanofi and no-one else in connection with the matters referred to in this announcement and will not be responsible to anyone other than Sanofi for providing the protections afforded to clients of GSBE or for providing advice in connection with the matters referred to in this announcement. Neither GSBE nor its affiliates, nor their respective partners, directors, officers, employees or agents are responsible to anyone other than Sanofi for providing the protections afforded to clients of GSBE or for providing advice in connection with the matters referred to in this announcement. Dealing Disclosure Requirements Under Rule 8.3(a) of the Takeover Rules, any person who is "interested" (directly or indirectly) in 1% or more of any class of "relevant securities" of an "offeree" or of any securities exchange "offeror" (being any "offeror" other than an "offeror" in respect of which it has been announced that its "offer" is, or is likely to be, solely in cash) must make an "opening position disclosure" following the commencement of the "offer period" and, if later, following the announcement in which any securities exchange "offeror" is first identified. An "opening position disclosure" must contain details of the person's "interests" and short positions in, and rights to subscribe for, any "relevant securities" of each of (i) the "offeree" and (ii) any securities exchange "offeror(s)". An "opening position disclosure" by a person to whom Rule 8.3(a) applies must be made by no later than 3.30 pm (US Eastern time) on the 10th "business day" following the commencement of the "offer period" and, if appropriate, by no later than 3.30 pm (US Eastern time) on the 10th "business day" following the announcement in which any securities exchange "offeror" is first identified. Relevant persons who deal in the "relevant securities" of the "offeree" or of a securities exchange "offeror" prior to the deadline for making an "opening position disclosure" must instead make a "dealing" disclosure. Under Rule 8.3(b) of the Takeover Rules, any person who is, or becomes, "interested" in 1% or more of any class of "relevant securities" of the "offeree" or of any securities exchange "offeror" must make a "dealing" disclosure if the person deals in any "relevant securities" of the "offeree" or of any securities exchange "offeror". A "dealing" disclosure must contain details of the dealing concerned and of the person's "interests" and short positions in, and rights to subscribe for, any "relevant securities" of each of (i) the "offeree" and (ii) any securities exchange "offeror(s)". A "dealing disclosure" by a person to whom Rule 8.3(b) applies must be made by no later than 3.30 pm (US Eastern time) on the "business day" following the date of the relevant "dealing". A dealing disclosure must contain the details specified in Rule 8.6(b) of the Takeover Rules, including details of the dealing concerned and of the person's interests and short positions in any relevant securities of the "offeree" or of any securities exchange "offeror". If two or more persons co-operate on the basis of any agreement, either express or tacit, either oral or written, to acquire an "interest" in "relevant securities" of an "offeree" or of any securities exchange "offeror", they will be deemed to be a single person for the purpose of Rule 8.3 of the Takeover Rules. "Opening position disclosures" must also be made by the "offeree" and by any "offeror" and "dealings" disclosures must also be made by the "offeree", by any "offeror" and by any persons "acting in concert" with any of them in the circumstances set out in the Takeover Rules (see Rules 8.1, 8.2 and 8.4). A disclosure table, giving details of the companies in whose "relevant securities" opening position disclosures and dealing disclosures should be made, can be found on the Irish Takeover Panel's website at www.irishtakeoverpanel.ie. "Interests in securities" arise, in summary, when a person has long economic exposure, whether conditional or absolute, to changes in the price of securities. In particular, a person will be treated as having an "interest" by virtue of the ownership or control of securities, or by virtue of any option in respect of, or derivative referenced to, securities. Terms in quotation marks are defined in the Takeover Rules, which can be found on the Irish Takeover Panel's website. If you are in any doubt as to whether or not you are required to disclose an "opening position" or "dealing" under Rule 8, please consult the Irish Takeover Panel's website at www.irishtakeoverpanel.ie or contact the Irish Takeover Panel on telephone number +353 1 678 9020. No offer or solicitation This announcement is not intended to, and does not, constitute or form part of any offer, invitation or the solicitation of an offer to purchase, otherwise acquire, subscribe for, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction, whether pursuant to this announcement or otherwise. The distribution of this announcement in jurisdictions outside Ireland and the United States may be restricted by law and therefore persons into whose possession this announcement comes should inform themselves about, and observe, such restrictions. Any failure to comply with the restrictions may constitute a violation of the securities law of any such jurisdiction. Publication on a website In accordance with Rule 26.1 of the Takeover Rules, a copy of this announcement will be available on Sanofi's website at www.sanofi.com/rule26compliance by no later than 12 noon (US Eastern time) on the business day following publication of this announcement. The content of any website referred to in this announcement is not incorporated into, and does not form part of, this announcement. Forward-Looking Statement This announcement contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts and may include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words expects, anticipates, believes, intends, estimates, plans and similar expressions. Although Sanofis management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the possibility that a transaction will not be pursued and/or an offer will not be made, failure to obtain necessary shareholder or regulatory approvals or required financing or to satisfy any of the other conditions to a potential transaction, adverse effects on the market price of our ordinary shares and/or on our operating results for any reason, including, without limitation, because of a failure to complete a transaction, failure to realize the expected benefits of a transaction, negative effects of an announcement or consummation or failure to consummate a transaction on the market price of our ordinary shares, significant transaction costs and/or unknown liabilities and general economic and market conditions that affect the combined companies following any transaction. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under Risk Factors and Cautionary Statement Regarding Forward-Looking Statements in Sanofis annual report on Form 20-F for the year ended December 31, 2021. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. Attachment Press_Release Source: West Corporation Nov 17, 2022: Banco Santander Press Release: European Commission approves Enjaymo (sutimlimab) for treatment of hemolytic anemia in adult patients with cold agglutinin disease European Commission approves Enjaymo (sutimlimab) for treatment of hemolytic anemia in adult patients with cold agglutinin disease Enjaymo is the first-and-only approved therapeutic option approved for hemolytic anemia in adult patients with cold agglutinin disease Paris, November 17, 2022. The European Commission (EC) has granted marketing authorization for Enjaymo (sutimlimab) for the treatment of hemolytic anemia in adult patients with cold agglutinin disease (CAD), a rare, serious, and chronic autoimmune hemolytic anemia, where the bodys immune system mistakenly attacks healthy red blood cells and causes their rupture, known as hemolysis. Dietmar Berger, MD, PhDChief Medical Officer, Global Head of Development at SanofiThis approval highlights our ambition to develop first- and best-in-class medicines that transform peoples lives. Up until now, patients in Europe had to rely on a combination of cold avoidance, blood transfusions and off-label treatments to manage their disease. The approval of Enjaymo by the European Commission provides patients, for the first time, with access to a therapy that can make a meaningful difference in the treatment and daily experience of living with CAD. Enjaymo is currently the only approved treatment for CAD and is a first-in-class humanized monoclonal antibody that is designed to selectively target and inhibit the classical complement pathway specific serine protease, C1s. It will be available as a 50mg/mL solution for infusion. Alexander Roth, MDDepartment of Hematology and Stem Cell Transplantation, University Hospital, University of Duisburg-Essen, GermanyCoupled with diagnostic journeys that can last years, the impact of fatigue on quality of life in CAD is often debilitating and is comparable to conditions such as cancer-related anemia and other autoimmune disorders. Clinicians now have a much-needed therapeutic option to offer to their patients. About the CADENZA and CARDINAL Clinical Trials The EC approval is based on data from two Phase 3 clinical trials: CADENZA, a double-blind, placebo-controlled clinical trial of adults with CAD without a recent history of blood transfusion (within the past 6 months), and CARDINAL, a 26-week open label, single-arm pivotal study in patients with CAD who have had a recent blood transfusion. In the CADENZA Part A trial, eligible patients were randomized 1:1 to receive a fixed weight-based dose (6.5g or 7.5g) of Enjaymo or placebo via intravenous infusion on Day 0, Day 7, and then once every other week up to Week 26. The open-label Part B of the study assessed long-term safety as well as durability of response to Enjaymo in patients with CAD. In the CADENZA Part A study, Enjaymo met its primary composite endpoint and all secondary endpoints and demonstrated inhibition of hemolysis, increase in hemoglobin levels, and clinically meaningful improvement in The Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue scores. Enjaymo demonstrated an acceptable safety profile and was generally well-tolerated. 96% of patients in the Enjaymo group and 100% of patients in the placebo group experienced at least one treatment emergent adverse event (TEAE). Headache (22.7% vs 10.0%), hypertension (22.7% vs 0%), rhinitis (18.2% vs 0%), Raynaud phenomenon (18.2% vs 0%), and acrocyanosis (13.6% vs 0%) were reported more frequently in Enajymo-treated patients compared with placebo. In the CARDINAL Part A trial, patients received a fixed weight-based dose (6.5g or 7.5g) of Enjaymo via intravenous infusion on Day 0, Day 7, and then once every other week up to Week 26. Part B of the study evaluated the long-term safety as well as durability of response to Enjaymo in patients with CAD over a 2-year follow up. In the CARDINAL Part A study, the efficacy of Enjaymo was assessed based on the achievement of a primary composite endpoint (Hb12 g/dL or an increase of at least 2 g/dL; no blood transfusion or prohibited medications from Weeks 5 through 26) and different secondary endpoints, including improvements in hemoglobin, normalization of bilirubin, and FACIT-fatigue score. The most common adverse reactions occurring in 10% or more of patients were respiratory tract infection, viral infection, diarrhea, dyspepsia, cough, arthralgia, arthritis, and peripheral edema. Serious adverse reactions were reported in 13% (3/24) of patients who received Enjaymo. These serious adverse reactions were streptococcal sepsis and staphylococcal wound infection (n=1), arthralgia (n=1), and respiratory tract infection (n=1). About Enjaymo (sutimlimab) Enjaymo is a humanized monoclonal antibody that is designed to selectively target and inhibit C1s in the classical complement pathway, which is part of the innate immune system. By blocking C1s, Enjaymo inhibits the activation of the complement cascade in the immune system and inhibits C1-activated hemolysis in CAD to prevent the abnormal destruction of healthy red blood cells. Enjaymo does not inhibit the lectin and alternative pathways. Enjaymo was approved by the US Food and Drug Administration (FDA) in February 2022 as the first and only treatment indicated to decrease the need for red blood cell transfusion due to hemolysis in adults with CAD. The Japanese Ministry of Health, Labor and Welfare approved Enjaymo in June 2022. The European Medicines Agency (EMA) also made the decision to maintain orphan designation. About cold agglutinin disease Cold agglutinin disease (CAD) is a rare type of autoimmune hemolytic anemia, where part of the bodys immune system mistakenly destroys healthy red blood cells (hemolysis). CAD impacts the lives of an estimated 12,000 people in the US, Europe, and Japan and is associated with profound fatigue and increased risk of thromboembolic events and mortality. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Media RelationsSandrine Guendoul|+ 33 6 25 09 14 25 |sandrine.guendoul@sanofi.comSally Bain|+ 1 617 834 6026 |sally.bain@sanofi.comKate Conway|+ 1508 364 4931 |kate.conway@sanofi.com Investor RelationsEva Schaefer-Jansen|+ 33 7 86 80 56 39 |eva.schaefer-jansen@sanofi.comArnaud Delepine|+ 33 6 73 69 36 93 | arnaud.delepine@sanofi.comCorentine Driancourt|+ 33 6 40 56 92 21 | corentine.driancourt@sanofi.comFelix Lauscher|+ 1908612 7239 | felix.lauscher@sanofi.comPriya Nanduri|+ 1 617 764 6418| priya.nanduri@sanofi.com Nathalie Pham|+ 33 7 85 93 30 17 | nathalie.pham@sanofi.com Sanofi Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements are generally identified by the words expects, anticipates, believes, intends, estimates, plans and similar expressions. Although Sanofis management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under Risk Factors and Cautionary Statement Regarding Forward-Looking Statements in Sanofis annual report on Form 20-F for the year ended December 31, 2021. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. Attachment Source: West Corporation Nov 11, 2022: Banco Santander Press Release: Dupixent (dupilumab) recommended for EU approval by the CHMP for the treatment of prurigo nodularis Dupixent (dupilumab) recommended for EU approval by the CHMP for the treatment of prurigo nodularis Recommendation is based on data from two pivotal trials showing Dupixent significantly improved itch, skin lesions and health-related quality of life in adults with prurigo nodularisIf approved, Dupixent would be the first and only targeted medicine specifically indicated for prurigo nodularis in the European Union Paris and Tarrytown, N.Y. November 11, 2022. The European Medicines Agencys Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending the approval of Dupixent (dupilumab) in the European Union (EU) to treat adults with moderate-to-severe prurigo nodularis who are candidates for systemic therapy. The European Commission is expected to announce a final decision on the Dupixent application in the coming months. In September 2022, Dupixent was approved by the U.S. Food and Drug Administration for the treatment of adult patients with prurigo nodularis. Prurigo nodularis is a chronic, debilitating skin disease with underlying type 2 inflammation and has one of the highest impacts on a patients quality of life among inflammatory skin diseases due to the extreme itch it causes. Those with prurigo nodularis experience intense, persistent itch with thick skin lesions (called nodules) that can cover most of the body. The disease is often painful with burning, stinging and tingling of the skin and can negatively affect mental health, activities of daily living and social interactions. High-potency topical steroids are commonly prescribed but are associated with safety risks if used long-term. The positive CHMP opinion is supported by data from two Phase 3 trials, PRIME and PRIME2, showing Dupixent significantly reduced itch (the primary endpoint) and skin lesions compared to placebo. Dupixent also significantly improved health-related quality of life while reducing measures of skin pain and symptoms of anxiety/depression. The safety results of the trial were generally consistent with the known safety profile of Dupixent in its approved dermatology indication. Adverse events more commonly observed with Dupixent compared to placebo included conjunctivitis. The use of Dupixent in adults with moderate-to-severe prurigo nodularis is investigational in the EU and is not yet approved. About Dupixent Dupixent is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not an immunosuppressant. The Dupixent development program has shown significant clinical benefit and a decrease in type 2 inflammation in Phase 3 trials, establishing that IL-4 and IL-13 are key and central drivers of the type 2 inflammation that plays a major role in multiple related and often co-morbid diseases. These diseases include approved indications for Dupixent, such as atopic dermatitis, asthma and chronic rhinosinusitis with nasal polyposis (CRSwNP), as well as investigational diseases prurigo nodularis and eosinophilic esophagitis (EoE) in the EU. Dupixent has received regulatory approvals in one or more countries around the world for use in certain patients with atopic dermatitis, prurigo nodularis, asthma, CRSwNP or EoE in different age populations. Dupixent is currently approved across these indications in the U.S. and for one or more of these indications in more than 60 countries, including in the European Union and Japan. More than 500,000 patients have been treated with Dupixent globally. Dupilumab Development Program Dupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement. To date, dupilumab has been studied across more than 60 clinical trials involving more than 10,000 patients with various chronic diseases driven in part by type 2 inflammation. In addition to the currently approved indications, Sanofi and Regeneron are studying dupilumab in a broad range of diseases driven by type 2 inflammation or other allergic processes in Phase 3 trials, including pediatric EoE, hand and foot atopic dermatitis, chronic inducible urticaria-cold, chronic spontaneous urticaria, chronic pruritus of unknown origin, chronic obstructive pulmonary disease with evidence of type 2 inflammation, chronic rhinosinusitis without nasal polyposis, allergic fungal rhinosinusitis, allergic bronchopulmonary aspergillosis and bullous pemphigoid. These potential uses of dupilumab are currently under clinical investigation, and the safety and efficacy in these conditions have not been fully evaluated by any regulatory authority. About Regeneron Regeneron is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led for nearly 35 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, hematologic conditions, infectious diseases and rare diseases. Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite technologies, such as VelocImmune, which uses unique genetically humanized mice to produce optimized fully human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world. For more information, please visit www.Regeneron.com or follow @Regeneron on Twitter. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Sanofi Media RelationsSally Bain|+ 1 617 834 6026 |sally.bain@sanofi.com Sanofi Investor RelationsEva Schaefer-Jansen | + 33 7 86 80 56 39 | eva.schaefer-jansen@sanofi.com Arnaud Delepine | + 33 06 73 69 36 93 | arnaud.delepine@sanofi.com Corentine Driancourt | + 33 06 40 56 92 | corentine.driancourt@sanofi.com Felix Lauscher | + 1 908 612 7239 | felix.lauscher@sanofi.com Priya Nanduri |+ 1 617 764 6418 | priya.nanduri@sanofi.com Nathalie Pham | + 33 07 85 93 30 17 | nathalie.pham@sanofi.com Regeneron Media RelationsHannah Kwagh | + 1 914 847 6315 | hannah.kwagh@regeneron.com Regeneron Investor RelationsVesna Tosic | + 914 847 5443 | vesna.tosic@regeneron.com Sanofi Disclaimers or Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements are generally identified by the words "expects", "anticipates", "believes", "intends", "estimates", "plans" and similar expressions. Although Sanofi's management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. Any material effect of COVID-19 on any of the foregoing could also adversely impact us. This situation is changing rapidly and additional impacts may arise of which we are not currently aware and may exacerbate other previously identified risks. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in Sanofi's annual report on Form 20-F for the year ended December 31, 2021. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. Regeneron Forward-Looking Statements and Use of Digital Media This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. (Regeneron or the Company), and actual events or results may differ materially from these forward-looking statements. Words such as anticipate, expect, intend, plan, believe, seek, estimate, variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the impact of SARS-CoV-2 (the virus that has caused the COVID-19 pandemic) on Regenerons business and its employees, collaborators, and suppliers and other third parties on which Regeneron relies, Regenerons and its collaborators ability to continue to conduct research and clinical programs, Regenerons ability to manage its supply chain, net product sales of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, Regenerons Products), and the global economy; the nature, timing, and possible success and therapeutic applications of Regenerons Products and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, Regenerons Product Candidates) and research and clinical programs now underway or planned, including without limitation Dupixent (dupilumab); the impact of the opinion adopted by the European Medicines Agency's Committee for Medicinal Products for Human Use discussed in this press release on potential approval by the European Commission of Dupixent to treat adults with moderate-to-severe prurigo nodularis and the timing of any such approval; uncertainty of the utilization, market acceptance, and commercial success of Regenerons Products and Regenerons Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary), including the studies discussed or referenced in this press release, on any of the foregoing or any potential regulatory approval of Regenerons Products and Regenerons Product Candidates; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regenerons Product Candidates and new indications for Regenerons Products, such as Dupixent for the treatment of pediatric eosinophilic esophagitis, hand and foot atopic dermatitis, chronic inducible urticaria-cold, chronic spontaneous urticaria, chronic pruritis of unknown origin, chronic obstructive pulmonary disease with evidence of type 2 inflammation, chronic rhinosinusitis without nasal polyposis, allergic fungal rhinosinusitis, allergic bronchopulmonary aspergillosis, bullous pemphigoidand, other potential indications; the ability of Regenerons collaborators, licensees, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regenerons Products and Regenerons Product Candidates; the ability of Regeneron to manage supply chains for multiple products and product candidates; safety issues resulting from the administration of Regenerons Products (such as Dupixent) and Regenerons Product Candidates in patients, including serious complications or side effects in connection with the use of Regenerons Products and Regenerons Product Candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict Regenerons ability to continue to develop or commercialize Regenerons Products and Regenerons Product Candidates, including without limitation Dupixent; ongoing regulatory obligations and oversight impacting Regenerons Products, research and clinical programs, and business, including those relating to patient privacy; the availability and extent of reimbursement of Regenerons Products from third-party payers, including private payer healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payers and new policies and procedures adopted by such payers; competing drugs and product candidates that may be superior to, or more cost effective than, Regenerons Products and Regenerons Product Candidates; the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators or licensees may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license, collaboration, or supply agreement, including Regenerons agreements with Sanofi and Bayer (or their respective affiliated companies, as applicable) to be cancelled or terminated; and risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA (aflibercept) Injection, Praluent (alirocumab), and REGEN-COV (casirivimab and imdevimab)), other litigation and other proceedings and government investigations relating to the Company and/or its operations, the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regenerons business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regenerons filings with the U.S. Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2021 and its Form 10-Q for the quarterly period ended September 30, 2022. Any forward-looking statements are made based on managements current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise. Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regenerons media and investor relations website (http://newsroom.regeneron.com) and its Twitter feed (http://twitter.com/regeneron). Attachment Source: West Corporation Nov 10, 2022: Banco Santander Press Release: Sanofi and GSKs next-generation COVID-19 booster vaccine VidPrevtyn Beta approved by the European Commission Sanofi and GSKs next-generation COVID-19 booster vaccine VidPrevtyn Beta approved by the European Commission First and only next-generation protein-based adjuvanted COVID-19 booster approved in EuropeStrong immune response against all tested variants of concernReady to supply for fall-winter COVID-19 vaccination campaigns in Europe Paris, November 10, 2022. After the European Medicines Agencys Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for VidPrevtyn Beta, the vaccine was approved by the European Commission, as a booster for the prevention of COVID-19 in adults 18 years of age and older. Designed to provide broad protection against multiple variants, the protein-based COVID-19 booster vaccine is based on the Beta variant antigen and includes GSKs pandemic adjuvant. VidPrevtyn Beta is indicated as a booster for active immunization against SARS_CoV_2 in adults who have previously received an mRNA or adenoviral COVID vaccine. Shipments of VidPrevtyn Beta are ready to be distributed to European countries as per Advance Purchase Agreements. Thomas TriompheExecutive Vice President, Vaccines, SanofiTodays approval validates our research in developing a novel solution for the COVID-19 pandemic. As were ready to start first shipments, VidPrevtyn Beta will be an important new option to protect populations against multiple strains of COVID-19. Philip DormitzerGlobal Head of Research and Development Vaccines, GSKThis EC approval is an important step in providing further vaccine solutions to Europe for the coming winter. Our protein-based, adjuvanted vaccine candidate has the potential to make an important contribution to public health as the pandemic evolves further. In registration studies, carried out at times when Omicron strains were predominantly circulating, the vaccine induced a strong immune response against multiple variants. Registration studies included a Phase 3 primary efficacy trial (VAT08 Stage 2) and two separate immunogenicity studies, including one comparative study with approved mRNA booster as comparatori,ii. About VidPrevtyn BetaVidPrevtyn Beta is a monovalent, recombinant-protein next-generation COVID-19 vaccine developed by Sanofi, modelled on the Beta variant and including GSKs pandemic adjuvant. The same recombinant-protein technology is used in Sanofis approved seasonal flu vaccines. Next-generation COVID-19 vaccines are based on a variant-adapted approach, using a strain other than the parental strain of SARS-CoV-2 (D614 strain). About COVIBOOST Immunogenicity & Safety StudyThe independent COVIBOOST (VAT013) study conducted by the Assistance Publique Hopitaux de Paris (AP-HP) investigated VidPrevtyn Beta following primary vaccination with two doses of Pfizer-BioNTechs Comirnaty vaccine (BNT162b2). VidPrevtyn Beta generated a higher immune response (as measured by neutralizing antibody titers) than Pfizer-BioNTechs booster or the Sanofi-GSK first-generation booster, both of which target the original D614 parent strain. In this study, which included 247 adult subjects (18-73 years-old), all three vaccines also elicited neutralizing antibodies against the Omicron BA.1 variant, with highest responses generated by the Sanofi-GSK next-generation candidate, one month after injection. VidPrevtyn Beta also elicited around 2.5 times more neutralizing antibodies against Omicron BA.1 and, in an exploratory analysis, against BA.4 / BA.5 strains than mRNA COVID-19 booster comparator. About the VAT02 Immunogenicity & Safety StudyImmunogenicity studies included VAT02 Cohort 2 and COVIBOOST which evaluated the booster formulation modelled on the Beta variant and including GSKs pandemic adjuvant. In the Phase 3 VAT02 Cohort 2 study, the vaccine induced (at day 15 following booster vaccination) a significant boost in antibody titers above baseline against multiple variants of concern (13-fold increase against D614 parent virus, 34-fold increase against the COVID-19 Beta strain) in 18-55 years-old adults previously primed with mRNA COVID-19 vaccines. In the VAT02 cohort 2 study, reactions were mostly mild to moderate, transient and self resolutive. About the VAT08 Stage 2 Efficacy & Safety StudyThe VAT08 Phase 3 Stage 2 study is a randomized, double-blind, placebo-controlled trial investigating primary vaccination with a bivalent COVID-19 vaccine containing both parental (D614) and Beta strains. The results showed a 64.7% efficacy against symptomatic SARS-CoV-2 infection in adults, regardless of their SARS-CoV-2 infection status prior to vaccination, and 75.1% efficacy in participants previously infected with SARS-CoV-2. This study was the first ever to report efficacy data in an Omicron environment. Across all the above-mentioned studies, the Sanofi-GSK bivalent next-generation vaccine candidate was well-tolerated, with an acceptable safety profile. About BARDA supportResearch and development for VidPrevtyn are supported by U.S. federal funds from the Biomedical Advanced Research and Development Authority (BARDA), Administration for Strategic Preparedness and Response at the U.S. Department of Health and Human Services under Contract # HHSO100201600005I, and in collaboration with the U.S. Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense under Contract # W15QKN-16-9-1002, and the National Institute of Allergy and Infectious Diseases (NIAID). About the Sanofi and GSK partnershipIn the collaboration between the two companies, Sanofi provides its recombinant antigen and will be the marketing authorization holder. GSK contributes with its pandemic adjuvant, both established vaccine platforms that have proven successful against influenza. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Media RelationsSandrine Guendoul|+ 33 6 25 09 14 25 |sandrine.guendoul@sanofi.comVictor Rouault|+ 33 6 70 93 71 40 |victor.rouault@sanofi.comSally Bain|+ 1 617 834 6026 |sally.bain@sanofi.comEvan Berland | + 1 215 432 0234 | evan.berland@sanofi.com Investor RelationsEva Schaefer-Jansen|+ 33 7 86 80 56 39 |eva.schaefer-jansen@sanofi.comArnaud Delepine|+ 33 6 73 69 36 93 | arnaud.delepine@sanofi.comCorentine Driancourt|+ 33 6 40 56 92 21 | corentine.driancourt@sanofi.comFelix Lauscher|+ 1908612 7239 | felix.lauscher@sanofi.comPriya Nanduri| +1 617 764 6418 |priya.nanduri@sanofi.com Nathalie Pham|+ 33 7 85 93 30 17 | nathalie.pham@sanofi.com Sanofi Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements are generally identified by the words expects, anticipates, believes, intends, estimates, plans and similar expressions. Although Sanofis management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under Risk Factors and Cautionary Statement Regarding Forward-Looking Statements in Sanofis annual report on Form 20-F for the year ended December 31, 2021. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. i https://www.sanofi.com/en/media-room/press-releases/2022/2022-06-24-05-29-02-2468538ii https://www.sanofi.com/en/media-room/press-releases/2022/2022-06-13-05-30-00-2460833 Attachment Press Release Source: West Corporation Nov 04, 2022: Banco Santander Press Release: European Commission grants first approval worldwide of Beyfortus (nirsevimab) for prevention of RSV disease in infants European Commission grants first approval worldwide of Beyfortus (nirsevimab) for prevention of RSV disease in infants Beyfortus is the first and only broadly protective option against RSV for newborns and infantsResults from the clinical development program reinforce Beyfortus consistency in reducing RSV infections requiring medical care, including hospitalizations Paris, November 4, 2022. The European Commission has approved Beyfortus (nirsevimab) for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants during their first RSV season. RSV is a common and highly contagious seasonal virus, infecting nearly all children by the age of two.1,2 Beyfortus is the first and only single-dose RSV protective option for the broad infant population, including those born healthy, at term or preterm, or with specific health conditions. Beyfortus is being developed jointly by Sanofi and AstraZeneca. Thomas TriompheExecutive Vice President, Vaccines, SanofiToday is a landmark day for RSV prevention, as decades of research and development come together in the worlds first approval of a broadly protective option against RSV disease. Once launched, Beyfortus will offer parents the ability to help protect their babies during their first RSV season. Iskra ReicVaccines and Immune Therapies Unit, AstraZeneca Beyfortus is the first single-dose passive immunization against respiratory syncytial virus to gain approval in Europe and is also the first and only preventative option approved for a broad infant population. Todays marketing authorization of Beyfortus marks a significant achievement for the scientific community and addresses a persistent, global unmet need in RSV prevention. Silke MaderChairwoman of the Executive Board and Co-Founder of the European Foundation for the Care of Newborn Infants (EFCNI) Respiratory syncytial virus represents a health threat among infants, and each year we see the impact it can have on families, healthcare providers and the healthcare system. At EFCNI, we are excited about the opportunity to expand prevention efforts to all infants, as we believe this can help ease the current emotional, physical and financial burdens of RSV. The European Commission is the first regulatory body to grant approval to Beyfortus. The approval was based on results from the Beyfortus clinical development program, including the Phase 3 MELODY, Phase 2/3 MEDLEY and Phase 2b trials and follows the recommendation by The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency in September 2022.3-11 In the MELODY and Phase 2b trials, Beyfortus met its primary endpoint of reducing the incidence of medically attended lower respiratory tract infections (LRTI) caused by RSV during the RSV season vs. placebo with a single dose.3-8 The safety profile of Beyfortus was similar to placebo. Beyfortus also demonstrated a comparable safety and tolerability profile to palivizumab in the Phase 2/3 MEDLEY trial.9-10,12 RSV is the most common cause of LRTI, including bronchiolitis and pneumonia, in infants.13It is also a leading cause of hospitalization in all infants, with most hospitalizations for RSV occurring in healthy infants born at term.14-17 Globally, in 2019, there were approximately 33 million cases of acute lower respiratory infections leading to more than three million hospitalizations, and it was estimated that there were 26,300 in-hospital deaths of children younger than five years.18 RSV-related direct medical costs, globally including hospital, outpatient and follow-up care were estimated at 4.82 billion in 2017.19 About Beyfortus Beyfortus, a long-acting antibody designed for all infants for protection against RSV disease from birth through their first RSV season with a single dose, is developed jointly by Sanofi and AstraZeneca. Beyfortus has been developed to offer newborns and infants direct RSV protection via an antibody to help prevent LRTI caused by RSV. Monoclonal antibodies do not require the activation of the immune system to help offer timely, rapid and direct protection against the disease.20 Beyfortus has been granted marketing authorization in the European Union for the prevention of RSV lower respiratory tract disease in newborns and infants from birth during their first RSV season. In March 2017, Sanofi and AstraZeneca announced anagreementto develop and commercialize Beyfortus. Under the terms of the agreement, AstraZeneca leads all development and manufacturing activities and Sanofi leads commercialization activities and records revenue. Under the terms of the global agreement, Sanofi made an upfront payment of 120m, has paid a development milestone of 30m and will pay up to a further 465m upon achievement of certain development and sales-related milestones. The two companies share all costs and profits. Beyfortus has been granted designations to facilitate expedited development by several regulatory agencies around the world. These include Breakthrough Therapy Designation by The China Center for Drug Evaluation under the National Medical Products Administration;Breakthrough Therapy Designationfrom the US Food and Drug Administration; access granted to the European Medicines Agency (EMA)PRIority MEdicinesscheme; Promising Innovative Medicine designation by the UK Medicines and Healthcare products Regulatory Agency; and has been named a medicine for prioritized development under the Project for Drug Selection to Promote New Drug Development in Pediatrics by the Japan Agency for Medical Research and Development (AMED). The safety and efficacy of Beyfortus was evaluated under an accelerated assessment procedure by the EMA. About the clinical trials The Phase 2b trial was a randomized, placebo-controlled trial designed to measure the efficacy of Beyfortus(nirsevimab) against medically attended LRTI through 150 days post-dose. Healthy preterm infants of 2935 weeks gestation were randomized (2:1) to receive a single 50mg intramuscular injection of Beyfortus or placebo. The primary endpoint was met, reducing the incidence of medically attended LRTI, caused by RSV by 70.1% (95% CI: 52.3, 81.2) compared to placebo. Between November 2016 and December 2017, 1,453 infants were randomized (Beyfortus, n=969; placebo, n=484) at the RSV season start. Studies were conducted in both hemispheres, at 164 sites in 23 countries.5,6Data was publishedin theNew England Journal of Medicine(NEJM)in July 2020. The dosing regimen was recommended based on further exploration of the phase 2b data.5 The subsequent Phase 3 study, MELODY, applied the recommended dosing regimen.3,4 The Phase 3 MELODY trial was a randomized, placebo-controlled trial conducted across 21 countries designed to determine efficacy of Beyfortus against medically attended LRTI due to RSV confirmed by reverse transcriptase polymerase chain reaction testing through 150 days after dosing, versus placebo, in healthy late preterm and term infants (35 weeks gestational age or greater) entering their first RSV season.3,4The primary endpoint was met, reducing the incidence of medically attended LRTI, such as bronchiolitis or pneumonia, caused by RSV by 74.5% (95% CI 49.6, 87.1; P<0.001) compared to placebo. Infants were randomized (2:1) to receive a single 50mg (in infants weighing <5kg) or 100mg (in infants weighing 5kg) intramuscular injection of Beyfortus or placebo. Between July 2019 and March 2020, 1,490 infants were randomized to either Beyfortus or placebo at the RSV season start.3,4Data was published on the primary analysisinNEJMin March 2022. Findings from Beyfortus clinical trial program include a pre-specified pooled analysis of the Phase 3 MELODY trial and the recommended dose from the Phase 2b trial, in which an efficacy (relative risk reduction versus placebo) of 79.5% (95% CI 65.9, 87.7; P<0.0001) was seen against medically attended LRTI, such as bronchiolitis or pneumonia, caused by RSV in infants born at term or preterm entering their first RSV season.7 The pooled analysis studied healthy preterm and term infants who received the recommended dose of Beyfortus based on weight compared to placebo through Day 151 and showed an efficacy of 77.3% (95% CI 50.3, 89.7; P<0.001) against RSV LRTI hospitalizations, as published inNEJMin March 2022.3,7 MEDLEY was a Phase 2/3, randomized, double-blind, palivizumab-controlled trial with the primary objective of assessing safety and tolerability for Beyfortus in preterm infants and infants with congenital heart disease (CHD) and/or chronic lung disease of prematurity (CLD) eligible to receive palivizumab.9,10 Between July 2019 and May 2021, approximately 918 infants entering their first RSV season were randomized to receive a single 50mg (in infants weighing <5kg) or 100mg (in infants weighing 5kg) intramuscular injection of Beyfortus or palivizumab. Safety was assessed by monitoring the occurrence of treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) through 360 days post-dose.9,10 Serum levels of Beyfortus following dosing (on day 151) in this trial were comparable with those observed in the Phase 3 MELODY trial, indicating similar protection in this population to that in the healthy term and late preterm infants is likely.9 Data was published in NEJM in March 2022. The results of MELODY, Phase 2/3 MEDLEY and the Phase 2b trials illustrate that Beyfortus helps protect infants during their first RSV season against RSV disease with a single dose.3-10 This all-infant population includes preterm, healthy late preterm and term infants, as well as infants with specific conditions. These trials form the basis of regulatory submissions that began in 2022. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Media RelationsSandrine Guendoul|+ 33 6 25 09 14 25 |sandrine.guendoul@sanofi.comSally Bain|+ 1 617 834 6026 |sally.bain@sanofi.comNicolas Obrist|+ 33 6 77 21 27 55 |nicolas.obrist@sanofi.comKate Conway|+ 1508364 4931 |kate.conway@sanofi.com Investor RelationsEva Schaefer-Jansen|+ 33 7 86 80 56 39 |eva.schaefer-jansen@sanofi.comArnaud Delepine|+ 33 6 73 69 36 93 | arnaud.delepine@sanofi.comCorentine Driancourt|+ 33 6 40 56 92 21 | corentine.driancourt@sanofi.comFelix Lauscher|+ 1908612 7239 | felix.lauscher@sanofi.comPriya Nanduri | +1 617 764 6418 |priya.nanduri@sanofi.com Nathalie Pham|+ 33 7 85 93 30 17 | nathalie.pham@sanofi.com Sanofi Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements are generally identified by the words expects, anticipates, believes, intends, estimates, plans and similar expressions. Although Sanofis management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under Risk Factors and Cautionary Statement Regarding Forward-Looking Statements in Sanofis annual report on Form 20-F for the year ended December 31, 2021. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. References Glezen WP et al. Risk of primary infection and reinfection with respiratory syncytial virus. Am J Dis Child. 1986;140(6):543-5463. Collins et al. Viral and host factors in human respiratory syncytial virus pathogenesis. Journal of Virology. 2008:20402055.Hammitt LL, MD et al. Nirsevimab for Prevention of RSV in Healthy Late -Preterm and Term Infants. N Engl J Med. 2022;386 (9): 837-846. doi: 10.1056/NEJMoa2110275.Clinicaltrials.gov. A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended RSV LRTI in Healthy Late Preterm and Term Infants (MELODY). https://clinicaltrials.gov/ct2/show/NCT03979313. Accessed October 2022.Clinicaltrials.gov. A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended RSV LRTI in Healthy Preterm Infants. (MEDI8897 Ph2b). https://clinicaltrials.gov/ct2/show/results/NCT02878330. Accessed October 2022.Griffin P, MD et al. (2020). Single-Dose Nirsevimab for Prevention of RSV in Preterm Infants. NEJM 2020; 383: 415-425. DOI: 10.1056/NEJMoa1913556. Simoes, E, et al. Pooled efficacy of nirsevimab against RSV lower respiratory tract infection in preterm and term infants. ESPID 2022 Congress; 2022 May 9-13. Hybrid Congress.Wilkins, D, et al. Nirsevimab for the prevention of respiratory syncytial virus infection: neutralizing antibody levels following a single dose. ESPID 2022 Congress; 2022 May 9-13. Hybrid Congress.Domachowske J, MD et al. Safety of Nirsevimab for RSV in Infants with Heart or Lung Disease or Prematurity. N Engl J Med. 2022; 386 (9).Clinicaltrials.gov. A Study to Evaluate the Safety of MEDI8897 for the Prevention of Medically Attended Respiratory Syncytial Virus (RSV) Lower Respiratory Track Infection (LRTI) in High-risk Children. https://clinicaltrials.gov/ct2/show/NCT03959488 (MEDLEY). Accessed October 2022.European Medicines Agency. Beyfortus Summary of Committee for Medicinal Products for Human Use Opinion Available at: https://www.ema.europa.eu/en/medicines/human/summaries-opinion/beyfortus. Accessed October 2022Synagis - Summary of Product Characteristics (SmPC) - (eMC) [Internet]. Available from: https://www.ema.europa.eu/en/documents/product-information/synagis-epar-product-information_en.pdf Accessed October 2022.R K. Respiratory Syncytial Virus Vaccines. Plotkin SA, Orenstein WA, Offitt PA, Edwards KM, eds Plotkins Vaccines 7th ed Philadelphia. 2018;7th ed. Philadelphia:943-9.Leader S, Kohlhase K. Respiratory syncytial virus-coded pediatric hospitalizations, 1997 to 1999. The Pediatric infectious disease journal. 2002;21(7):629-32.McLaurin KK, Farr AM, Wade SW, Diakun DR, Stewart DL. Respiratory syncytial virus hospitalization outcomes and costs of full-term and preterm infants. Journal of Perinatology: official journal of the California Perinatal Association. 2016;36(11):990-6.Rha B, et al. Respiratory Syncytial Virus-Associated Hospitalizations Among Young Children: 2015-2016. Pediatrics. 2020;146:e20193611.Arriola CS, et al. Estimated Burden of Community-Onset Respiratory Syncytial Virus-Associated Hospitalizations Among Children Aged <2 Years in the United States, 2014-15. J Pediatric Infect Dis Soc. 2020;9:587-595Li Y, et al. Global, regional, and national disease burden estimates of acute lower respiratory infections due to respiratory syncytial virus in children younger than 5 years in 2019: a systematic analysis. Lancet 2022;399:9204764.Zhang S, et al. Cost of Respiratory Syncytial Virus-Associated Acute Lower Respiratory Infection Management in Young Children at the Regional and Global Level: A Systematic Review and Meta-Analysis. J Infect Dis. 2020;222(Suppl 7):S680-687.Centers for Disease Control and Prevention. Vaccines & Immunizations. August 18, 2017. https://www.cdc.gov/vaccines/vac-gen/immunity-types.htm. Accessed October 2022. Attachment Source: West Corporation Oct 28, 2022: Banco Santander Press Release: Continued strong growth in Q3 with key regulatory milestones achieved Continued strong growth in Q3 with key regulatory milestones achieved Paris, October 28, 2022 Q3 2022 sales growth of 9.0% at CER driven by Specialty Care and Vaccines Q3 2022 business EPS(1) up 17.9% at CER driven by higher sales and margin expansion Progress on Corporate Social Responsibility strategy Access to Medicine Foundation recognized Sanofi Global Health Units work to improve insulin access in low-middle income countries Key R&D milestones and regulatory achievements Dupixent approved in the U.S. as the first and only treatment for adults with prurigo nodularisFDA granted priority review for Altuviiio (efanesoctocog alfa) for the treatment of hemophilia AFDA approved XenpozymeTM for the treatment of acid sphingomyelinase deficiency (ASMD) in adult and pediatric patientsCHMP recommended approval of Beyfortus (nirsevimab) for prevention of RSV disease in infants CHMP recommended approval of Enjaymo in adult patients with cold agglutinin disease (CAD) Full-year 2022 business EPS guidance revise upward Sanofi Chief Executive Officer, Paul Hudson, commented: Our strong results for the third quarter demonstrate that Sanofi is on the right path, with a remarkable performance of 20% growth in both Specialty Care and Vaccines, leading us to again raise our business EPS guidance for the full-year. Our commitment to breakthrough science is bearing fruit. Three of our priority first or best-in-class medicines reached important regulatory milestones. Beyfortus was recommended by EMAs CHMP for prevention of RSV disease in all infants while Altuviiio was granted priority review by the US FDA for people with hemophilia A. Dupixent keeps breaking new ground with a recent US FDA approval making it the first and only treatment indicated for prurigo nodularis, the second indication in dermatology, and fifth overall for Dupixent in the US. Social impact continues to be at the center of our companys agenda, as illustrated by the introduction of our first two carbon offsetting programs. Looking ahead, we are well positioned to achieve our BOI margin target of 30% in 2022 and to stay focused on our ambition to transform the practice of medicines for patients around the world. Source: West Corporation Oct 11, 2022: Banco Santander Press Release: Dupixent (dupilumab) late-breaking Phase 3 data presented at UEG Week 2022 showed significant histological remission of eosinophilic esophagitis (EoE) in children 1 to 11 years old Dupixent (dupilumab) late-breaking Phase 3 data presented at UEG Week 2022 showed significant histological remission of eosinophilic esophagitis (EoE) in children 1 to 11 years old 68% of children on a higher dose of Dupixent achieved histological disease remission at week 16First and only Phase 3 trial to show positive results in this patient population; currently no approved treatments are specifically indicated for children under 12 years of age with EoEData reinforce well-established efficacy and safety profile of Dupixent Paris and Tarrytown, N.Y. October 11, 2022. Late-breaking positive results from a Phase 3 trial evaluating the investigational use of Dupixent (dupilumab) in children aged 1 to 11 years with active eosinophilic esophagitis (EoE) will be presented today at United European Gastroenterology (UEG) Week 2022. The data will be submitted to regulatory authorities around the world, starting with the U.S. Food and Drug Administration (FDA) in 2023. In May 2022, Dupixent 300 mg weekly was approved by the FDA to treat EoE in people aged 12 years and older, weighing at least 40 kg. Mirna Chehade, M.DMount Sinai Center for Eosinophilic Disorders, Icahn School of Medicine, Mount SinaiEosinophilic esophagitis impacts a childs fundamental ability to eat, which is especially critical in early childhood when healthy weight gain is vital to long-term health and development. These Phase 3 data support the potential of dupilumab to reduce esophageal damage - caused in part by underlying type 2 inflammation - and showed histological disease remission and signs of weight gain impacting the growth percentile for those children on higher dose Dupixent. Dupixent led to significant improvements in the primary efficacy measure for higher (n=37) and lower (n=31) dose groups at 16 weeks in the randomized, placebo-controlled Phase 3 trial. Among children treated with Dupixent, 68% of children on higher dose and 58% of patients on lower dose achieved the primary endpoint of significant histological disease remission, compared to 3% for placebo (both p<0.0001). Children on the higher dose regimen also experienced significant improvements in abnormal endoscopic findings of their esophagus, with a reduction of 3.5 points compared to an increase of 0.3 points for placebo (p<0.0001). Symptomatically, higher dose Dupixent led to a numerical improvement in the proportion of days children experienced disease symptoms from baseline as reported by their caregivers compared to placebo, though not statistically significant. Additionally, a prespecified exploratory analysis was presented which found higher dose Dupixent led to a 3.09 percentile increase in body weight for age percentile from baseline, compared to 0.29 for placebo. Safety results were generally consistent with the known safety profile of Dupixent in its approved EoE indication for children and adults aged 12 years and older who weigh at least 40 kg. For the 16-week treatment period, the overall rates of adverse events (AEs) were 79% (higher dose n=27/37, lower dose n=26/30) for Dupixent and 91% (n=31/34) for placebo. AEs most commonly observed with Dupixent (5%) compared to placebo included COVID-19 (higher dose n=5/37, lower dose n=9/30, placebo n=0/34; all cases were mild or moderate and did not lead to study discontinuation), rash (higher dose n=3/37, lower dose n=3/30, placebo n=2/34), headache (higher dose n=1/37, lower dose n=4/30, placebo n=1/34), viral gastroenteritis (higher dose n=4/37, lower dose n=0/30, placebo n=1/34), diarrhea (higher dose n=2/37, lower dose n=2/30, placebo n=1/34) and nausea (higher dose n=1/37, lower dose n=3/30, placebo n=0/34). Rates of treatment discontinuation due to AEs prior to week 16 were 0% (higher dose n=0/37, lower dose n=0/30) for Dupixent and 6% (n=2/34) for placebo. The potential use of Dupixent in children with EoE aged 1 to 11 years is currently under clinical development, and the safety and efficacy have not been evaluated by any regulatory authority. About Eosinophilic Esophagitis EoE is a chronic inflammatory disease that damages the esophagus and prevents it from working properly. The results seen with Dupixent in adults and children with EoE demonstrate that IL-4 and IL-13 are key and central drivers of the type 2 inflammation underlying this disease. In children, common symptoms of EoE include acid reflux, vomiting, abdominal discomfort, trouble swallowing, and a failure to thrive. These symptoms can impact growth, weight gain and development, and can cause food-related fear and anxiety which can persist through adulthood. Diet adjustments, which oftentimes include the elimination of many foods, is the standard treatment for EoE, as well as the use of treatments not approved for the disease in children. These include proton pump inhibitors, swallowed topical corticosteroids, or in severe cases, a feeding tube, which may be used to ensure proper caloric intake and weight gain. Of the approximately 21,000 children under the age of 12 in the U.S. currently being treated for EoE, about 9,000 do not satisfactorily respond to their current treatment regimen and potentially require advanced therapy. About the Dupixent Pediatric Eosinophilic Esophagitis Trial The Phase 3, randomized, double-blind, placebo-controlled trial evaluated the efficacy and safety of Dupixent in young children aged 1 to 11 years with EoE, as determined by histological, endoscopic and patient- or caregiver-reported measures. At baseline, 98% of these patients had at least one co-existing type 2 inflammatory disease such as food allergy, allergic rhinitis, asthma and atopic dermatitis. Patients received Dupixent subcutaneously at either a higher dose or lower dose regimen based on their weight (ranging from 5 kg to <60 kg) over a 16-week period, at which point all endpoints were assessed. The dosing frequency ranged between every two weeks and every four weeks, based on weight. The primary endpoint was histological disease remission, which was defined as peak esophageal intraepithelial eosinophil count of 6 eosinophils (eos)/high power field (hpf). Secondary endpoints included abnormal endoscopic findings (EoE Endoscopic Reference Score [EoE-EREFS] on a 0-18 scale), as well as changes in caregiver-reported symptoms (proportion of days with 1 or more EoE signs [e.g., stomach pain, vomiting, food refusal] by the Pediatric EoE Sign/Symptom Questionnaire-caregiver version [PESQ-C]). The PESQ-C is a novel endpoint developed by Sanofi and Regeneron used for the first time in this trial, designed to assess symptoms in young children through their caregivers (as signs), as children may have difficulty verbalizing their symptoms themselves. An exploratory endpoint assessed change from baseline in body weight for age percentile. The trial is ongoing with a 36-week extended active treatment period, followed by a 108-week open-label extension period to evaluate long-term outcomes. These results, as well as a more detailed lower dose results, will be presented or published in the future. About Dupixent Dupixent is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not an immunosuppressant. The Dupixent development program has shown significant clinical benefit and a decrease in type 2 inflammation in Phase 3 trials, establishing that IL-4 and IL-13 are key and central drivers of the type 2 inflammation that plays a major role in multiple related and often co-morbid diseases. These diseases include approved indications for Dupixent such as asthma, atopic dermatitis, chronic rhinosinusitis with nasal polyposis (CRSwNP), EoE and prurigo nodularis (PN). Dupixent has received regulatory approvals in one or more countries around the world for use in in certain patients with atopic dermatitis, asthma, CRSwNP, EoE or PN in different age populations. Dupixent is currently approved across these indications in the U.S. and for one or more of these indications in more than 60 countries, including in the European Union and Japan. More than 500,000 patients have been treated with Dupixent globally. Dupilumab Development Program Dupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement. To date, dupilumab has been studied across more than 60 clinical trials involving more than 10,000 patients with various chronic diseases driven in part by type 2 inflammation. In addition to the currently approved indications, Sanofi and Regeneron are studying dupilumab in a broad range of diseases driven by type 2 inflammation or other allergic processes in Phase 3 trials, including pediatric EoE, hand and foot atopic dermatitis, chronic inducible urticaria-cold, chronic spontaneous urticaria, chronic pruritis of unknown origin, chronic obstructive pulmonary disease with evidence of type 2 inflammation, chronic rhinosinusitis without nasal polyposis, allergic fungal rhinosinusitis, allergic bronchopulmonary aspergillosis and bullous pemphigoid. These potential uses of dupilumab are currently under clinical investigation, and the safety and efficacy in these conditions have not been fully evaluated by any regulatory authority. About RegeneronRegeneron is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led for nearly 35 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, hematologic conditions, infectious diseases and rare diseases. Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite technologies, such as VelocImmune, which uses unique genetically humanized mice to produce optimized fully human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world. For more information, please visit www.Regeneron.com or follow @Regeneron on Twitter. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY. Sanofi Media RelationsSally Bain|+ 1 617 834 6026 |sally.bain@sanofi.com Sanofi Investor RelationsEva Schaefer-Jansen | + 33 7 86 80 56 39 | eva.schaefer-jansen@sanofi.com Arnaud Delepine | + 33 06 73 69 36 93 | arnaud.delepine@sanofi.com Corentine Driancourt | + 33 06 40 56 92 21 | corentine.driancourt@sanofi.com Felix Lauscher | + 1 908 612 7239 | felix.lauscher@sanofi.com Priya Nanduri |+ 1 617 764 6418 | priya.nanduri@sanofi.com Nathalie Pham | + 33 07 85 93 30 17 | nathalie.pham@sanofi.com Regeneron Media RelationsSharon Chen | + 1 914 847 1546 | sharon.chen@regeneron.commailto: Regeneron Investor RelationsVesna Tosic | + 914 847 5443 | vesna.tosic@regeneron.com Sanofi Disclaimers or Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements are generally identified by the words "expects", "anticipates", "believes", "intends", "estimates", "plans" and similar expressions. Although Sanofi's management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. Any material effect of COVID-19 on any of the foregoing could also adversely impact us. This situation is changing rapidly and additional impacts may arise of which we are not currently aware and may exacerbate other previously identified risks. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in Sanofi's annual report on Form 20-F for the year ended December 31, 2021. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. Regeneron Forward-Looking Statements and Use of Digital MediaThis press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance ofRegeneron Pharmaceuticals, Inc.(Regeneron or the Company), and actual events or results may differ materially from these forward-looking statements. Words such as anticipate, expect, intend, plan, believe, seek, estimate, variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the impact of SARS-CoV-2 (the virus that has caused the COVID-19 pandemic) on Regenerons business and its employees, collaborators, and suppliers and other third parties on which Regeneron relies, Regenerons and its collaborators ability to continue to conduct research and clinical programs, Regenerons ability to manage its supply chain, net product sales of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, Regenerons Products), and the global economy; the nature, timing, and possible success and therapeutic applications of Regenerons Products and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, Regenerons Product Candidates) and research and clinical programs now underway or planned, including without limitation Dupixent (dupilumab); the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regenerons Product Candidates and new indications for Regenerons Products, such asDupixent for the treatment of children aged 1 to 11 years with active eosinophilic esophagitis as discussed in this press release as well as for the treatment of hand and foot atopic dermatitis, chronic inducible urticaria-cold, chronic spontaneous urticaria, chronic pruritis of unknown origin, chronic obstructive pulmonary disease with evidence of type 2 inflammation, chronic rhinosinusitis without nasal polyposis, allergic fungal rhinosinusitis, allergic bronchopulmonary aspergillosis, bullous pemphigoid, and other potential indications; uncertainty of the utilization, market acceptance, and commercial success of Regenerons Products and Regenerons Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary), including the studies discussed or referenced in this press release, on any of the foregoing or any potential regulatory approval of Regenerons Products and Regenerons Product Candidates (such as Dupixent for the treatment of children aged 1 to 11 years with active eosinophilic esophagitis); the ability of Regenerons collaborators, licensees, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regenerons Products and Regenerons Product Candidates; the ability of Regeneron to manage supply chains for multiple products and product candidates; safety issues resulting from the administration of Regenerons Products (such as Dupixent) and Regenerons Product Candidates in patients, including serious complications or side effects in connection with the use of Regenerons Products and Regenerons Product Candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict Regenerons ability to continue to develop or commercialize Regenerons Products and Regenerons Product Candidates, including without limitation Dupixent; ongoing regulatory obligations and oversight impacting Regenerons Products, research and clinical programs, and business, including those relating to patient privacy; the availability and extent of reimbursement of Regenerons Products from third-party payers, including private payer healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payers and new policies and procedures adopted by such payers; competing drugs and product candidates that may be superior to, or more cost effective than, Regenerons Products and Regenerons Product Candidates; the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators or licensees may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license, collaboration, or supply agreement, including Regenerons agreements with Sanofi and Bayer (or their respective affiliated companies, as applicable) to be cancelled or terminated; and risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA(aflibercept) Injection, Praluent(alirocumab), and REGEN-COV (casirivimab and imdevimab)), other litigation and other proceedings and government investigations relating to the Company and/or its operations, the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regenerons business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regenerons filings with theU.S. Securities and Exchange Commission, including its Form 10-K for the year endedDecember 31, 2021 and its Form 10-Q for the quarterly period ended June 30, 2022. Any forward-looking statements are made based on managements current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise. Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regenerons media and investor relations website (http://newsroom.regeneron.com) and its Twitter feed (http://twitter.com/regeneron). Attachment Source: West Corporation Sep 28, 2022: Banco Santander Press Release: Dupixent (dupilumab) approved by FDA as the first and only treatment indicated for prurigo nodularis Dupixent (dupilumab) approved by FDA as the first and only treatment indicated for prurigo nodularis Dupixent significantly reduced itch and skin lesions compared to placebo in direct-to-Phase 3 program consisting of two pivotal trialsAbout 75,000 adults in the U.S. living with prurigo nodularis are most in need of new treatment options Approval represents the second dermatology indication for Dupixent and fifth disease indication overall in the U.S. Paris and Tarrytown, N.Y. September 28, 2022. The U.S. Food and Drug Administration (FDA) has approved Dupixent (dupilumab) for the treatment of adult patients with prurigo nodularis. With this approval, Dupixent becomes the first and only medicine specifically indicated to treat prurigo nodularis in the U.S. Prurigo nodularis is a chronic, debilitating skin disease with underlying type 2 inflammation and its impact on quality of life is one of the highest among inflammatory skin diseases. The FDA evaluated the Dupixent application for prurigo nodularis under Priority Review, which is granted to therapies that have the potential to provide significant improvements in the treatment, diagnosis or prevention of serious conditions. Naimish Patel, M.DHead of Global Development, Immunology and Inflammation, SanofiUntil today, there were limited treatment options to manage the relentless itch and associated sensations of burning and stinging skin that can negatively impact the lives of patients struggling with prurigo nodularis. Dupixent has the potential to transform the standard-of-care for prurigo nodularis patients by alleviating the key hallmarks of the disease, such as reducing itch and achieving clearer skin. With Dupixent now approved in two diseases in dermatology where type 2 inflammation is a central driver, we look forward to further evaluating the potential of inhibiting IL-4 and IL-13 in other chronic skin diseases. George D. Yancopoulos, M.D., Ph.D.President and Chief Scientific Officer, RegeneronPatients living with prurigo nodularis must often contend with dozens, if not hundreds, of itchy and painful nodules covering their body and have not had an approved treatment option for their disease. Dupixent has already transformed the treatment landscape of several diseases driven by type 2 inflammation including atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis and eosinophilic esophagitis and been prescribed to more than half a million patients around the world for its approved indications. With this approval, those suffering with prurigo nodularis finally have a medicine to address the debilitating signs and symptoms of the disease. The FDA approval is based on data from two Phase 3 trials, PRIME and PRIME2, evaluating the efficacy and safety of Dupixent in adults with prurigo nodularis. Efficacy in these trials assessed the proportion of subjects with clinically meaningful reduction in itch, clearing of skin, or both: About three times as many Dupixent patients (60% and 58%) experienced a clinically meaningful reduction in itch from baseline at 24 weeks, compared to 18% and 20% for placebo, the primary endpoint in PRIME.44% and 37% of Dupixent patients experienced a clinically meaningful reduction in itch from baseline at 12 weeks, compared to 16% and 22% for placebo, the primary endpoint in PRIME2. More than twice as many Dupixent patients (48% and 45%) achieved clear or almost clear skin at 24 weeks, compared to 18% and 16% for placebo.More than three times as many Dupixent patients (39% and 32%) experienced both a clinically meaningful reduction in itch and clear or almost clear skin, compared to 9% and 9% of placebo patients at 24 weeks. The safety results of the trial were generally consistent with the known safety profile of Dupixent in its approved dermatology indication. The most common adverse events (2%) from pooled PRIME and PRIME2 data more frequently observed with Dupixent than placebo were nasopharyngitis (5% Dupixent, 2% placebo), conjunctivitis (4% Dupixent, 1% placebo), herpes infection (3% Dupixent, 0% placebo), dizziness (3% Dupixent, 1% placebo), muscle pain (3% Dupixent, 1% placebo), and diarrhea (3% Dupixent, 1% placebo). A regulatory filing for prurigo nodularis is under review by the European Medicines Agency, and submissions to regulatory authorities in additional countries are also planned in 2022. About Prurigo NodularisPeople with prurigo nodularis experience intense, persistent itch with thick skin lesions (called nodules) that can cover most of the body. The disease is often painful, with burning, stinging and tingling of the skin. The impact of prurigo nodularis on quality of life is one of the highest among inflammatory skin diseases due to the extreme itch and is comparable to other debilitating chronic diseases that can negatively affect mental health, activities of daily living and social interactions. High-potency topical steroids are commonly prescribed but are associated with safety risks if used long-term. There are about 75,000 adults in the U.S. living with prurigo nodularis and are most in need of new treatment options. About the Dupixent Prurigo Nodularis TrialsThe PRIME and PRIME2 Phase 3 double-blind, placebo-controlled trials evaluated the efficacy and safety of Dupixent in 311 adults with uncontrolled prurigo nodularis. In PRIME and PRIME2, the primary endpoint evaluated the proportion of patients with clinically meaningful improvement in itch from baseline (measured by a 4-point reduction in Worst-Itch Numeric Rating Scale [WI-NRS] on a 0-10 scale) at 24 and 12 weeks, respectively. Additional endpoints included the proportion of patients with clear or almost clear skin of nodules at 24 weeks (measured by a score of 0 or 1 on the Investigator's Global Assessment PN-Stage [IGA PN-S] on a 0-4 scale), and the proportion of patients who achieved a clinically meaningful response in both WI-NRS and IGA PN-S. About DupixentDupixent is administered as an injection under the skin (subcutaneous injection) at different injection sites. In patients aged 18 years and older with prurigo nodularis, Dupixent 300 mg is administered with a pre-filled syringe or pre-filled pen every two weeks following an initial loading dose. Dupixent is intended for use under the guidance of a healthcare professional and can be given in a clinic or at home by self-administration after training by a healthcare professional. Regeneron and Sanofi are committed to helping patients in the U.S. who are prescribed Dupixent gain access to the medicine and receive the support they may need with the DUPIXENT MyWay program. For more information, please call 1-844-DUPIXENT (1-844-387-4936) or visit www.DUPIXENT.com. Dupixent has received regulatory approvals in one or more countries around the world for use in certain patients with atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), eosinophilic esophagitis (EoE) or prurigo nodularis in different age populations. Dupixent is currently approved across these indications in the U.S. and for one or more of these indications in more than 60 countries, including in the European Union and Japan. More than 500,000 patients have been treated with Dupixent globally. Dupixent is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not an immunosuppressant. The Dupixent development program has shown significant clinical benefit and a decrease in type 2 inflammation in Phase 3 trials, establishing that IL-4 and IL-13 are key and central drivers of the type 2 inflammation that plays a major role in multiple related and often co-morbid diseases. These diseases include approved indications for Dupixent such as prurigo nodularis, atopic dermatitis, asthma, CRSwNP and EoE. Dupilumab Development ProgramDupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement. To date, dupilumab has been studied across more than 60 clinical trials involving more than 10,000 patients with various chronic diseases driven in part by type 2 inflammation. In addition to the currently approved indications, Sanofi and Regeneron are studying dupilumab in a broad range of diseases driven by type 2 inflammation or other allergic processes in Phase 3 trials, including pediatric eosinophilic esophagitis, hand and foot atopic dermatitis, chronic inducible urticaria-cold, chronic spontaneous urticaria, chronic pruritis of unknown origin, chronic obstructive pulmonary disease with evidence of type 2 inflammation, chronic rhinosinusitis without nasal polyposis, allergic fungal rhinosinusitis, allergic bronchopulmonary aspergillosis and bullous pemphigoid. These potential uses of dupilumab are currently under clinical investigation, and the safety and efficacy in these conditions have not been fully evaluated by any regulatory authority. About Regeneron Regeneron is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led for nearly 35 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, hematologic conditions, infectious diseases and rare diseases. Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite technologies, such as VelocImmune, which uses unique genetically humanized mice to produce optimized fully human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world. For more information, please visit www.Regeneron.com or follow @Regeneron on Twitter. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY. Sanofi Media RelationsSally Bain|+ 1 617 834 6026 |sally.bain@sanofi.com Sanofi Investor RelationsEva Schaefer-Jansen | + 33 7 86 80 56 39 | eva.schaefer-jansen@sanofi.com Arnaud Delepine | + 33 06 73 69 36 93 | arnaud.delepine@sanofi.com Corentine Driancourt | + 33 06 40 56 92 | corentine.driancourt@sanofi.com Felix Lauscher | + 1 908 612 7239 | felix.lauscher@sanofi.com Priya Nanduri |+ 1 617 764 6418 | priya.nanduri@sanofi.com Nathalie Pham | + 33 07 85 93 30 17 | nathalie.pham@sanofi.com Regeneron Media RelationsHannah Kwagh | + 1 914 847 6314 | hannah.kwagh@regeneron.com Regeneron Investor RelationsVesna Tosic | + 914 847 5443 | vesna.tosic@regeneron.com Sanofi Disclaimers or Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements are generally identified by the words "expects", "anticipates", "believes", "intends", "estimates", "plans" and similar expressions. Although Sanofi's management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. Any material effect of COVID-19 on any of the foregoing could also adversely impact us. This situation is changing rapidly and additional impacts may arise of which we are not currently aware and may exacerbate other previously identified risks. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in Sanofi's annual report on Form 20-F for the year ended December 31, 2021. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. Regeneron Forward-Looking Statements and Use of Digital MediaThis press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance ofRegeneron Pharmaceuticals, Inc.("Regeneron" or the "Company"), and actual events or results may differ materially from these forward-looking statements. Words such as "anticipate," "expect," "intend," "plan," "believe," "seek," "estimate," variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the impact of SARS-CoV-2 (the virus that has caused the COVID-19 pandemic) on Regeneron's business and its employees, collaborators, and suppliers and other third parties on which Regeneron relies, Regeneron's and its collaborators' ability to continue to conduct research and clinical programs, Regeneron's ability to manage its supply chain, net product sales of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, "Regeneron's Products"), and the global economy; the nature, timing, and possible success and therapeutic applications of Regeneron's Products and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, "Regeneron's Product Candidates") and research and clinical programs now underway or planned, including without limitation Dupixent(dupilumab) for the treatment of prurigo nodularis; uncertainty of the utilization, market acceptance, and commercial success of Regeneron's Products (such as Dupixent) and Regeneron's Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary), including the studies discussed or referenced in this press release, on any of the foregoing; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron's Product Candidates and new indications for Regeneron's Products, such asDupixent for the treatment ofpediatric eosinophilic esophagitis, hand and foot atopic dermatitis, chronic inducible urticaria-cold, chronic spontaneous urticaria, chronic pruritis of unknown origin, chronic obstructive pulmonary disease with evidence of type 2 inflammation, chronic rhinosinusitis without nasal polyposis, allergic fungal rhinosinusitis, allergic bronchopulmonary aspergillosis, bullous pemphigoid, and other potential indications; the ability of Regeneron's collaborators, licensees, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regeneron's Products and Regeneron's Product Candidates; the ability of Regeneron to manage supply chains for multiple products and product candidates; safety issues resulting from the administration of Regeneron's Products (such as Dupixent) and Regeneron's Product Candidates in patients, including serious complications or side effects in connection with the use of Regeneron's Products and Regeneron's Product Candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron's ability to continue to develop or commercialize Regeneron's Products and Regeneron's Product Candidates, including without limitation Dupixent; ongoing regulatory obligations and oversight impacting Regeneron's Products, research and clinical programs, and business, including those relating to patient privacy; the availability and extent of reimbursement of Regeneron's Products from third-party payers, including private payer healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payers and new policies and procedures adopted by such payers; competing drugs and product candidates that may be superior to, or more cost effective than, Regeneron's Products and Regeneron's Product Candidates; the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators or licensees may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license, collaboration, or supply agreement, including Regeneron's agreements withSanofi, Bayer, and Teva Pharmaceutical Industries Ltd. (or their respective affiliated companies, as applicable) to be cancelled or terminated; and risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA(aflibercept) Injection, Dupixent, Praluent(alirocumab), and REGEN-COV(casirivimab and imdevimab)), other litigation and other proceedings and government investigations relating to the Company and/or its operations, the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regeneron's business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regeneron's filings with theU.S. Securities and Exchange Commission, including its Form 10-K for the year endedDecember 31, 2021 and its Form 10-Q for the quarterly period endedJune 30, 2022. Any forward-looking statements are made based on management's current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise. Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regeneron's media and investor relations website (http://newsroom.regeneron.com) and its Twitter feed (http://twitter.com/regeneron). Attachment Source: West Corporation Sep 28, 2022: Banco Santander Press Release: Availability of the Q3 2022 Memorandum for modelling purposes Availability of the Q3 2022 Memorandum for modelling purposes Paris, France September 28, 2022 - Sanofi announced today that its Q3 2022 Memorandum for modelling purposes is available on the "Investors" page of the company's website: https://www.sanofi.com/en/investors/financial-results-and-events/financial-results/Q3-results-2022 As for each quarter, Sanofi prepared this document to assist in the financial modelling of the Group's quarterly results. This document includes a reminder on various non-comparable items and exclusivity losses as well as the foreign currency impact and share count. Sanofi's third-quarter 2022 results will be published on October 28, 2022. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Media RelationsSandrine Guendoul|+ 33 6 25 09 14 25 |sandrine.guendoul@sanofi.comSally Bain|+ 1 617 834 6026 |sally.bain@sanofi.comNicolas Obrist|+ 33 6 77 21 27 55 |nicolas.obrist@sanofi.comVictor Rouault|+ 33 6 70 93 71 40 |victor.rouault@sanofi.com Investor RelationsEva Schaefer-Jansen|+ 33 7 86 80 56 39 |eva.schaefer-jansen@sanofi.comArnaud Delepine|+ 33 6 73 69 36 93 | arnaud.delepine@sanofi.comCorentine Driancourt|+ 33 6 40 56 92 21 | corentine.driancourt@sanofi.comFelix Lauscher|+ 1908612 7239 | felix.lauscher@sanofi.comPriya Nanduri| + 1 617 764 6418 |priya.nanduri@sanofi.com Nathalie Pham|+ 33 7 85 93 30 17 | nathalie.pham@sanofi.com Sanofi Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words expects, anticipates, believes, intends, estimates, plans and similar expressions. Although Sanofis management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofis ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. Any material effect of COVID-19 on any of the foregoing could also adversely impact us. This situation is changing rapidly and additional impacts may arise of which we are not currently aware and may exacerbate other previously identified risks. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under Risk Factors and Cautionary Statement Regarding Forward-Looking Statements in Sanofis annual report on Form 20-F for the year ended December 31, 2021. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. Attachment Press Release Source: West Corporation Sep 16, 2022: Banco Santander Press Release: CHMP recommends approval of Beyfortus (nirsevimab) for prevention of RSV disease in infants CHMP recommends approval of Beyfortus (nirsevimab) for prevention of RSV disease in infants Recommendation is based on the Beyfortus clinical trial program which demonstrated protection against medically attended lower respiratory tract infection caused by RSV with a single dose during the RSV seasonIf approved,Beyfortus would be the first broadly protective optionfornewborns and infants Paris, September 16, 2022. The European Medicines Agencys Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Beyfortus (nirsevimab) for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants during their first RSV season. If approved, Beyfortus would be the first and only single-dose passive immunization for the broad infant population, including those born healthy, at term or preterm, or with specific health conditions. Beyfortus is being developed jointly by Sanofi and AstraZeneca. Jean-Francois ToussaintGlobal Head of Research and Development Vaccines, Sanofi Todays positive CHMP opinion is one of the most significant public health achievements in RSV in decades and has the potential to alleviate the enormous physical and emotional burden that RSV can place on families and healthcare systems. With this endorsement, we are one step closer to achieving our goal of protecting all infants against RSV with a single dose. Iskra ReicExecutive Vice President, Vaccines and Immune Therapies, AstraZenecaThis positive CHMP opinion underscores Beyfortus potential as a ground-breaking, first-in-class passive immunization that could transform the medical communitys approach to RSV prevention in infants. The CHMP based its positive opinion on results from the Beyfortus clinical development program, including the Phase 3 MELODY, Phase 2/3 MEDLEY, and Phase 2b trials.1-8 In the MELODY and Phase 2b trials, Beyfortus met its primary endpoint of reducing the incidence of medically attended lower respiratory tract infections (LRTI) caused by RSV during the RSV season vs. placebo with a single dose. 1-6 The safety profile of Beyfortus was similar to placebo. Beyfortus also demonstrated a comparable safety and tolerability profile to palivizumab in the Phase 2/3 MEDLEY trial.7-8 RSV is the most common cause of LRTIs and a leading cause of hospitalization in all infants, with most hospitalizations occurring in infants born healthy and at term.9-13 RSV-related direct medical costs, globally including hospital, outpatient and follow-up care were estimated at 4.82 billion in 2017.14 Currently there is no preventative option available for all infants and treatment is limited to symptomatic relief.15,16 About Beyfortus Beyfortus (nirsevimab), an investigational long-acting antibody designed for all infants for protection against RSV disease from birth through their first RSV season with a single dose, is being developed jointly by Sanofi and AstraZeneca. Beyfortus has been developed to offer newborns and infants direct RSV protection via an antibody to help prevent LRTI caused by RSV. Monoclonal antibodies do not require the activation of the immune system to help offer timely, rapid and direct protection against disease.17 In March 2017, Sanofi and AstraZeneca announced anagreementto develop and commercialize Beyfortus. Under the terms of the agreement, AstraZeneca leads all development and manufacturing activities and Sanofi will lead commercialization activities and record revenues. Under the terms of the global agreement, Sanofi made an upfront payment of 120m, has paid a development milestone of 30m and will pay up to a further 465m upon achievement of certain development and sales-related milestones. The two companies share all costs and profits. Revenue from the agreement is reported as Collaboration Revenue in the Companys financial statements. Beyfortus has been granted designations to facilitate expedited development by several major regulatory agencies around the world. These include Breakthrough Therapy Designation by The China Center for Drug Evaluation under the National Medical Products Administration;Breakthrough Therapy Designationfrom the US Food and Drug Administration; access granted to the European Medicines Agency (EMA)PRIority MEdicinesscheme; Promising Innovative Medicine designation by the UK Medicines and Healthcare products Regulatory Agency; and named a medicine for prioritized development under the Project for Drug Selection to Promote New Drug Development in Pediatrics by the Japan Agency for Medical Research and Development (AMED). The safety and efficacy of Beyfortus was evaluated under an accelerated assessment procedure by the EMA. Beyfortus has not been approved by any regulatory authority. About the clinical trials The Phase 2b trial was a randomized, placebo-controlled trial designed to measure the efficacy of Beyfortus (nirsevimab) against medically attended LRTI through 150 days post-dose. Healthy preterm infants of 2935 weeks gestation were randomized (2:1) to receive a single 50mg intramuscular injection of Beyfortus or placebo. The primary endpoint was met, reducing the incidence of medically attended LRTI, caused by RSV by 70.1% (95% CI: 52.3, 81.2) compared to placebo. Between November 2016 and December 2017, 1,453 infants were randomized (Beyfortus, n=969; placebo, n=484) at the RSV season start. Studies were conducted in both hemispheres, at 164 sites in 23 countries.3,4Data was publishedin theNew England Journal of Medicine(NEJM)in July 2020. The dosing regimen was recommended based on further exploration of the phase 2b data.3 The subsequent Phase 3 study, MELODY, applied the recommended dosing regimen.2 The Phase 3 MELODY trial was a randomized, placebo-controlled trial conducted across 21 countries designed to determine efficacy of Beyfortus against medically attended LRTI due to RSV confirmed by reverse transcriptase polymerase chain reaction testing through 150 days after dosing, versus placebo, in healthy late preterm and term infants (35 weeks gestational age or greater) entering their first RSV season.1,2The primary endpoint was met, reducing the incidence of medically attended LRTI, such as bronchiolitis or pneumonia, caused by RSV by 74.5% (95% CI 49.6, 87.1; P<0.001) compared to placebo. Infants were randomized (2:1) to receive a single 50mg (in infants weighing <5kg) or 100mg (in infants weighing 5kg) intramuscular injection of Beyfortus or placebo. Between July 2019 and March 2020, 1,490 infants were randomized to either Beyfortus or placebo at the RSV season start.1,2Data was published on the primary analysisinNEJMin March 2022. Findings from Beyfortus clinical trial program include a pre-specified pooled analysis of the Phase 3 MELODY trial and the recommended dose from the Phase 2b trial, in which an efficacy (relative risk reduction versus placebo) of 79.5% (95% CI 65.9, 87.7; P<0.0001) was seen against medically attended LRTI, such as bronchiolitis or pneumonia, caused by RSV in infants born at term or preterm entering their first RSV season.5 The pooled analysis studied healthy preterm and term infants who received the recommended dose of Beyfortus based on weight compared to placebo through Day 151 and showed an efficacy of 77.3% (95% CI 50.3, 89.7; P<0.001) against RSV LRTI hospitalizations, as published inNEJMin March 2022.1,5 MEDLEY was a Phase 2/3, randomized, double-blind, palivizumab-controlled trial with the primary objective of assessing safety and tolerability for Beyfortus in preterm infants and infants with congenital heart disease (CHD) and/or chronic lung disease of prematurity (CLD) eligible to receive palivizumab.7,8 Between July 2019 and May 2021, approximately 918 infants entering their first RSV season were randomized to receive a single 50mg (in infants weighing <5kg) or 100mg (in infants weighing 5kg) intramuscular injection of Beyfortus or palivizumab. Safety was assessed by monitoring the occurrence of treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) through 360 days post-dose.7,8 Serum levels of nirsevimab following dosing (on day 151) in this trial were comparable with those observed in the Phase 3 MELODY trial, indicating similar protection in this population to that in the healthy term and late preterm infants is likely.7 Data was published in NEJM in March 2022. The results of MELODY, Phase 2/3 MEDLEY and the Phase 2b trials illustrate that Beyfortus helps protect infants during their first RSV season against RSV disease with a single dose.1-8 This all-infant population includes preterm, healthy late preterm and term infants, as well as infants with specific conditions. These trials form the basis of regulatory submissions that began in 2022. About RSV RSV is the most common cause of LRTI, including bronchiolitis and pneumonia, in infants.9It is also a leading cause of hospitalization in all infants, with most hospitalizations for RSV occurring in healthy infants born at term.10-13 Globally, in 2019, there were approximately 33 million cases of acute lower respiratory infections leading to more than three million hospitalizations, and it was estimated that there were 26,300 in-hospital deaths of children younger than five years.18 RSV-related direct medical costs, globally including hospital, outpatient and follow-up care were estimated at 4.82 billion in 2017.14 About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Media RelationsSandrine Guendoul|+ 33 6 25 09 14 25 |sandrine.guendoul@sanofi.comSally Bain|+ 1 617 834 6026 |sally.bain@sanofi.comNicolas Obrist|+ 33 6 77 21 27 55 |nicolas.obrist@sanofi.comKate Conway|+ 1508364 4931 |kate.conway@sanofi.com Investor RelationsEva Schaefer-Jansen|+ 33 7 86 80 56 39 |eva.schaefer-jansen@sanofi.comArnaud Delepine|+ 33 6 73 69 36 93 | arnaud.delepine@sanofi.comCorentine Driancourt|+ 33 6 40 56 92 21 | corentine.driancourt@sanofi.comFelix Lauscher|+ 1908612 7239 | felix.lauscher@sanofi.comPriya Nanduri | + 1 617 764 641 |priya.nanduri@sanofi.com Nathalie Pham|+ 33 7 85 93 30 17 | nathalie.pham@sanofi.com Sanofi Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words expects, anticipates, believes, intends, estimates, plans and similar expressions. Although Sanofis management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofis ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. Any material effect of COVID-19 on any of the foregoing could also adversely impact us. This situation is changing rapidly and additional impacts may arise of which we are not currently aware and may exacerbate other previously identified risks. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under Risk Factors and Cautionary Statement Regarding Forward-Looking Statements in Sanofis annual report on Form 20-F for the year ended December 31, 2020. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. References Attachment Source: West Corporation Sep 08, 2022: Banco Santander Press Release: Dupixent (dupilumab) late-breaking Phase 3 data at EADV 2022 showed significant improvements in signs and symptoms of prurigo nodularis Dupixent (dupilumab) late-breaking Phase 3 data at EADV 2022 showed significant improvements in signs and symptoms of prurigo nodularis Nearly three times as many Dupixent patients experienced clinically meaningful reductions in itch and skin lesions at 24 weeks compared to placebo There are currently no approved medicines specifically indicated to treat prurigo nodularis; regulatory submissions for Dupixent are under Priority Review in the U.S. and under review in the European Union22 Dupixent abstracts are being presented at the European Academy of Dermatology and Venereology (EADV) 2022 Congress across four dermatological diseases with underlying type 2 inflammation Paris and Tarrytown, N.Y. September 8, 2022. Detailed positive results from the Phase 3 PRIME trial evaluating Dupixent (dupilumab) in adults with uncontrolled prurigo nodularis were presented today in a late-breaking session at the European Academy of Dermatology and Venereology (EADV) 2022 Congress. These data from one of two pivotal trials in prurigo nodularis show Dupixent significantly reduced itch and skin lesions at 24 weeks. In total, 22 scientific abstracts are being presented at the EADV 2022 Congress discussing Dupixent in atopic dermatitis in patients as young as six months, and its investigational use in chronic spontaneous urticaria and bullous pemphigoid, in addition to prurigo nodularis. Gil Yosipovitch, M.D.Professor of Dermatology, Miller School of Medicine, University of Miami, Director of the Miami Itch Center, and principal investigator of the trialThese positive results from the second of two dupilumab Phase 3 trials in prurigo nodularis confirm inhibiting IL-4 and IL-13 can significantly reduce the unrelenting itch and extensive severe skin lesions that often impair patient quality of life. In my practice, relieving itch and clearing skin are often the top priorities for my patients across a range of chronic skin diseases. These data demonstrate dupilumab has the potential to address and manage these debilitating symptoms in another chronic skin disease with underlying type 2 inflammation. The late-breaking data presented at the EADV 2022 Congress are from the randomized, placebo-controlled Phase 3 PRIME trial, which met its primary and key secondary endpoints. At 24 weeks, among patients treated with Dupixent in the trial: More than three times as many (60%) experienced a clinically meaningful reduction in itch from baseline, the primary endpoint, compared to placebo patients (18%; p<0.0001).Nearly three times as many (48%) achieved clear or almost clear skin, a key secondary endpoint, compared to placebo patients (18%; p=0.0004). The safety results of the trial were generally consistent with the known safety profile of Dupixent in its approved dermatological indication. For the 24-week treatment period, overall rates of adverse events (AEs) were 71% for Dupixent and 63% for placebo. AEs most commonly observed with Dupixent (5%) included nasopharyngitis (5% Dupixent, 4% placebo) and headache (5% Dupixent, 5% placebo). The rate of treatment discontinuation due to AEs prior to week 24 was 0% for Dupixent compared to 4% for placebo. A numerically lower rate of skin infections was observed with Dupixent (4% Dupixent, 9% placebo). Results from this and an earlier Phase 3 trial, PRIME2, will form the basis of regulatory submissions around the world for Dupixent in prurigo nodularis this year. Regulatory submissions are already under review by the European Commission and the U.S. Food and Drug Administration, with the FDA granting Priority Review in May 2022 and a target action date of September 30, 2022. The potential uses of Dupilumab in prurigo nodularis, chronic spontaneous urticaria and bullous pemphigoid are currently under clinical development, and the safety and efficacy have not been fully evaluated by any regulatory authority. About Prurigo NodularisPeople with prurigo nodularis experience intense, persistent itch, with thick skin lesions (called nodules) that can cover most of the body. Prurigo nodularis is often described as painful with burning, stinging and tingling of the skin. The impact of uncontrolled prurigo nodularis on quality of life is one of the highest among inflammatory skin diseases due to the extreme itch and comparable to other debilitating chronic diseases that can negatively affect mental health, activities of daily living and social interactions. High-potency topical steroids are commonly prescribed but are associated with safety risks if used long-term. About the TrialPRIME, part of the LIBERTY-PN PRIME clinical program, was a randomized, Phase 3, double-blind, placebo-controlled trial that evaluated the efficacy and safety of Dupixent in 151 adults with uncontrolled prurigo nodularis. These included patients who were inadequately controlled with topical prescription therapies or for whom those therapies were not advisable. During the 24-week treatment period, patients received Dupixent or placebo every two weeks with or without topical treatments (low- or medium-dose topical corticosteroids or topical calcineurin inhibitors were continued if patients were using these treatments at randomization). The primary endpoint evaluated the proportion of patients with clinically meaningful improvement in itch at 24 weeks (measured by a 4-point reduction in Worst-Itch Numeric Rating Scale [WI-NRS] of 0-10). A key secondary endpoint was the proportion of patients with clear or almost clear skin at 24 weeks (measured by a score of 0 or 1 on the Investigator's Global Assessment PN-Stage [IGA PN-S] 0-4 scale). About DupixentDupixent is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not an immunosuppressant. The Dupixent development program has shown significant clinical benefit and a decrease in type 2 inflammation in Phase 3 trials, establishing that IL-4 and IL-13 are key and central drivers of the type 2 inflammation that plays a major role in multiple related and often co-morbid diseases. These diseases include approved indications for Dupixent such as asthma, atopic dermatitis, chronic rhinosinusitis with nasal polyposis (CRSwNP) and eosinophilic esophagitis (EoE), as well as investigational diseases such as prurigo nodularis. Dupixent has received regulatory approvals around the world for use in certain patients with atopic dermatitis, asthma, CRSwNP or EoE in different age populations. Dupixent is currently approved across these indications in the U.S. and for one or more of these indications in more than 60 countries, including in the European Union and Japan. More than 500,000 patients have been treated with Dupixent globally. Dupilumab Development ProgramDupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement. To date, dupilumab has been studied across more than 60 clinical trials involving more than 10,000 patients with various chronic diseases driven in part by type 2 inflammation. In addition to the currently approved indications, Sanofi and Regeneron are studying dupilumab in a broad range of diseases driven by type 2 inflammation or other allergic processes in Phase 3 trials, including prurigo nodularis, pediatric eosinophilic esophagitis, hand and foot atopic dermatitis, chronic inducible urticaria-cold, chronic spontaneous urticaria, chronic pruritis of unknown origin, chronic obstructive pulmonary disease with evidence of type 2 inflammation, chronic rhinosinusitis without nasal polyposis, allergic fungal rhinosinusitis, allergic bronchopulmonary aspergillosis and bullous pemphigoid. These potential uses of dupilumab are currently under clinical investigation, and the safety and efficacy in these conditions have not been fully evaluated by any regulatory authority. About RegeneronRegeneron is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led for nearly 35 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous FDA-approved treatments and product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, hematologic conditions, infectious diseases and rare diseases. Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite technologies, such as VelocImmune, which uses unique genetically humanized mice to produce optimized fully human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world. For more information, please visit www.Regeneron.com or follow @Regeneron on Twitter. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY. Sanofi Media RelationsSally Bain|+ 1 617 834 6026 |sally.bain@sanofi.com Sanofi Investor RelationsEva Schaefer-Jansen | + 33 7 86 80 56 39 | eva.schaefer-jansen@sanofi.com Arnaud Delepine | + 33 06 73 69 36 93 | arnaud.delepine@sanofi.com Corentine Driancourt | + 33 06 40 56 92 21 | corentine.driancourt@sanofi.com Felix Lauscher | + 1 908 612 7239 | felix.lauscher@sanofi.com Priya Nanduri | + 1 617 764 6418 | priya.nanduri@sanofi.com Nathalie Pham | + 33 07 85 93 30 17 | nathalie.pham@sanofi.com Regeneron Media RelationsHannah Kwagh | + 1 914 847 6314 | hannah.kwagh@regeneron.com Regeneron Investor RelationsVesna Tosic | + 914 847 5443 | vesna.tosic@regeneron.com Sanofi Forward-Looking Statements This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements are generally identified by the words "expects", "anticipates", "believes", "intends", "estimates", "plans" and similar expressions. Although Sanofi's management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. Any material effect of COVID-19 on any of the foregoing could also adversely impact us. This situation is changing rapidly and additional impacts may arise of which we are not currently aware and may exacerbate other previously identified risks. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in Sanofi's annual report on Form 20-F for the year ended December 31, 2021. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. Regeneron Forward-Looking Statements and Use of Digital Media This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. (Regeneron or the Company), and actual events or results may differ materially from these forward-looking statements. Words such as anticipate, expect, intend, plan, believe, seek, estimate, variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the impact of SARS-CoV-2 (the virus that has caused the COVID-19 pandemic) on Regenerons business and its employees, collaborators, and suppliers and other third parties on which Regeneron relies, Regenerons and its collaborators ability to continue to conduct research and clinical programs, Regenerons ability to manage its supply chain, net product sales of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, Regenerons Products), and the global economy; the nature, timing, and possible success and therapeutic applications of Regenerons Products and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, Regenerons Product Candidates) and research and clinical programs now underway or planned, including without limitation Dupixent (dupilumab) for the treatment of prurigo nodularis; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regenerons Product Candidates and new indications for Regenerons Products, such as Dupixent for the treatment of prurigo nodularis (including potential approval by the U.S. Food and Drug Administration and/or the European Commission as discussed in this press release), hand and foot atopic dermatitis, chronic obstructive pulmonary disease with evidence of type 2 inflammation, pediatric eosinophilic esophagitis, bullous pemphigoid, chronic spontaneous urticaria, chronic pruritis of unknown origin, chronic inducible urticaria-cold, chronic rhinosinusitis without nasal polyposis, allergic fungal rhinosinusitis, allergic bronchopulmonary aspergillosis, and other potential indications; uncertainty of the utilization, market acceptance, and commercial success of Regenerons Products (such as Dupixent) and Regenerons Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary), including the studies discussed or referenced in this press release, on any of the foregoing or any potential regulatory approval of Regenerons Products (such as Dupixent) and Regenerons Product Candidates; the ability of Regenerons collaborators, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regenerons Products and Regenerons Product Candidates; the ability of Regeneron to manage supply chains for multiple products and product candidates; safety issues resulting from the administration of Regenerons Products (such as Dupixent) and Regenerons Product Candidates in patients, including serious complications or side effects in connection with the use of Regenerons Products and Regenerons Product Candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict Regenerons ability to continue to develop or commercialize Regenerons Products and Regenerons Product Candidates, including without limitation Dupixent; ongoing regulatory obligations and oversight impacting Regenerons Products, research and clinical programs, and business, including those relating to patient privacy; the availability and extent of reimbursement of Regenerons Products from third-party payers, including private payer healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payers and new policies and procedures adopted by such payers; competing drugs and product candidates that may be superior to, or more cost effective than, Regenerons Products and Regenerons Product Candidates; the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license or collaboration agreement, including Regenerons agreements with Sanofi, Bayer, and Teva Pharmaceutical Industries Ltd. (or their respective affiliated companies, as applicable), to be cancelled or terminated; and risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA (aflibercept) Injection, Dupixent, Praluent (alirocumab), and REGEN-COV (casirivimab and imdevimab)), other litigation and other proceedings and government investigations relating to the Company and/or its operations, the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regenerons business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regenerons filings with the U.S. Securities and Exchange Commission, including its Form 10-K for the fiscal year ended December 31, 2021 and its Form 10-Q for the quarterly period ended June 30, 2022. Any forward-looking statements are made based on managements current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise. Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regenerons media and investor relations website (http://newsroom.regeneron.com) and its Twitter feed (http://twitter.com/regeneron). Attachment Source: West Corporation Sep 05, 2022: Banco Santander Press Release: Late-breaking Dupixent (dupilumab) data at ERS 2022 show consistent efficacy and safety profile for up to two years in children aged 6 to 11 years with moderate-to-severe asthma Late-breaking Dupixent (dupilumab) data at ERS 2022 show consistent efficacy and safety profile for up to two years in children aged 6 to 11 years with moderate-to-severe asthma Results from the longest global Phase 3 open-label extension trial in this age group in asthma show sustained improvement in lung function, low rate of asthma attacks and a consistent safety profile for up to two yearsData reinforce well-established efficacy and safety profile of Dupixent across age groups Paris and Tarrytown, N.Y. September 5, 2022. Results from a Phase 3 open-label extension trial demonstrated the efficacy and safety profile of Dupixent (dupilumab) as a maintenance therapy when added to other asthma medications was consistent for up to two years in children aged 6 to 11 years with uncontrolled moderate-to-severe asthma with evidence of type 2 inflammation. These results were presented today in a late-breaking session at the 2022 European Respiratory Society (ERS) International Congress, which coincides with the milestone that more than 500,000 people around the world have been treated with Dupixent in its approved indications. Leonard B. Bacharier, M.D.Professor of Pediatrics, Director of the Center for Pediatric Asthma Research, Monroe Carell Jr. Children's Hospital, Vanderbilt University Medical Center Children with uncontrolled moderate-to-severe asthma may experience long-term persistent coughing, difficulty breathing, unpredictable asthma attacks and impaired lung function, which can lead to complications later in life as they grow and develop. An established safety profile balanced with efficacy is always a priority when treating children with a chronic disease, such as those with uncontrolled moderate-to-severe asthma with an eosinophilic phenotype or oral corticosteroid dependent asthma. These new data further support the consistent safety profile of long-term Dupixent - which is indicated for the treatment of uncontrolled moderate to severe asthma with an eosinophilic phenotype or oral corticosteroid dependent asthma - and its ability to provide sustained improvements in lung function and reductions in asthma exacerbations in children as young as 6 years old. The results are from data in children who entered the extension trial after finishing active treatment or placebo in the Phase 3 trial (pivotal trial). Children in the extension trial were treated for up to an additional year with Dupixent, providing up to two years of data in total. Children treated with Dupixent in the extension trial experienced a: Low rate of severe asthma attacks with an average of 0.118-0.124 events per year, compared to 2.16-2.56 events per year at baseline in the pivotal trial. Sustained improvement in lung function at 52 weeks of 9.43-12.6 percentage points from baseline in the pivotal trial, measured by percent predicted FEV1 (FEV1pp). FEV1pp seeks to evaluate a patient's change in lung function compared to their predicted lung function based on age, height, sex and ethnicity to account for children's growing lung capacity at different stages of development. Children who switched from placebo in the pivotal trial to Dupixent in the extension trial demonstrated improvement of 8.71 percentage points in lung function at two weeks. The safety results of the trial were generally consistent with the known safety profile of Dupixent in its approved respiratory indications. Over the 52-week treatment period, the overall rates of adverse events (AEs) were 61-68%. The most common AEs (5%) were nasopharyngitis (9-10%), pharyngitis (6-10%), upper respiratory tract infection (4-8%), influenza (5-6%), eosinophilia (3-6%), allergic rhinitis (3-7%), diarrhea (4-6%) and injection site reactions (3-7%). About Pediatric AsthmaAsthma is one of the most common chronic diseases in children. Up to 85% of children with asthma may have type 2 inflammation and are more likely to have higher disease burden. Despite treatment with current standard-of-care inhaled corticosteroids and bronchodilators, these children may continue to experience serious symptoms such as coughing, wheezing and difficulty breathing. They also may require the use of multiple courses of systemic corticosteroids that carry significant risks. About the LIBERTY ASTHMA EXCURSION TrialThe Phase 3, multicenter, open-label extension trial evaluated the long-term safety and efficacy of Dupixent in 365 children with uncontrolled moderate-to-severe asthma who had previously participated in the placebo-controlled VOYAGE trial (the pivotal trial) when they were 6 to 11 years of age. Patients in the open-label extension trial received Dupixent 100 mg or 200 mg every two weeks or Dupixent 300 mg every four weeks, based on body weight, for 52 weeks. The primary endpoint assessed the number of patients experiencing any treatment emergent adverse event. Secondary endpoints included the annualized rate of severe asthma exacerbations over one year and change from pivotal trial baseline in FEV1pp. About Dupixent Dupixent is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not an immunosuppressant. The Dupixent development program has shown significant clinical benefit and a decrease in type 2 inflammation in Phase 3 trials, establishing that IL-4 and IL-13 are key and central drivers of the type 2 inflammation that plays a major role in multiple related and often co-morbid diseases. These diseases include approved indications for Dupixent such as asthma, atopic dermatitis, chronic rhinosinusitis with nasal polyposis (CRSwNP) and eosinophilic esophagitis (EoE), as well as investigational diseases such as prurigo nodularis. In the EU, Dupixent is approved in children aged 6 to 11 years as an add-on maintenance treatment for severe asthma with type 2 inflammation characterized by raised blood eosinophils and/or raised FeNO, who are inadequately controlled with medium to high dose inhaled corticosteroids (ICS) plus another medicinal product for maintenance treatment. For adolescents and adults 12 years and older with severe asthma with type 2 inflammation, patients must be inadequately controlled with high dose ICS plus another medicinal product for maintenance treatment. Dupixent has received regulatory approvals around the world for use in in certain patients with atopic dermatitis, asthma, CRSwNP or EoE in different age populations. Dupixent is currently approved across these indications in the U.S. and for one or more of these indications in more than 60 countries, including in the European Union and Japan. Dupilumab Development ProgramDupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement. To date, dupilumab has been studied across more than 60 clinical trials involving more than 10,000 patients with various chronic diseases driven in part by type 2 inflammation. In addition to the currently approved indications, Sanofi and Regeneron are studying dupilumab in a broad range of diseases driven by type 2 inflammation or other allergic processes in Phase 3 trials, including prurigo nodularis, pediatric eosinophilic esophagitis, hand and foot atopic dermatitis, chronic inducible urticaria-cold, chronic spontaneous urticaria, chronic pruritis of unknown origin, chronic obstructive pulmonary disease with evidence of type 2 inflammation, chronic rhinosinusitis without nasal polyposis, allergic fungal rhinosinusitis, allergic bronchopulmonary aspergillosis and bullous pemphigoid. These potential uses of dupilumab are currently under clinical investigation, and the safety and efficacy in these conditions have not been fully evaluated by any regulatory authority. About Regeneron Regeneron is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led for nearly 35 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous FDA-approved treatments and product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, hematologic conditions, infectious diseases and rare diseases. Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite technologies, such as VelocImmune, which uses unique genetically humanized mice to produce optimized fully human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world. For more information, please visit www.Regeneron.com or follow @Regeneron on Twitter. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY. Sanofi Media RelationsSally Bain|+ 1 617 834 6026 |sally.bain@sanofi.com Sanofi Investor RelationsEva Schaefer-Jansen | + 33 7 86 80 56 39 | eva.schaefer-jansen@sanofi.com Arnaud Delepine | + 33 6 73 69 36 93 | arnaud.delepine@sanofi.com Corentine Driancourt | + 33 6 40 56 92 21 | corentine.driancourt@sanofi.com Felix Lauscher | + 1 908 612 7239 | felix.lauscher@sanofi.com Priya Nanduri |+ 1 617 764 6418 | priya.nanduri@sanofi.com Nathalie Pham | + 33 7 85 93 30 17 | nathalie.pham@sanofi.com Regeneron Media RelationsSharon Chen | + 1 914 847 1546 | sharon.chen@regeneron.com Regeneron Investor RelationsVesna Tosic | + 914 847 5443 | vesna.tosic@regeneron.com Sanofi Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements are generally identified by the words "expects", "anticipates", "believes", "intends", "estimates", "plans" and similar expressions. Although Sanofi's management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. Any material effect of COVID-19 on any of the foregoing could also adversely impact us. This situation is changing rapidly and additional impacts may arise of which we are not currently aware and may exacerbate other previously identified risks. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in Sanofi's annual report on Form 20-F for the year ended December 31, 2021. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. Regeneron Forward-Looking Statements and Use of Digital Media This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. (Regeneron or the Company), and actual events or results may differ materially from these forward-looking statements. Words such as anticipate, expect, intend, plan, believe, seek, estimate, variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the impact of SARS-CoV-2 (the virus that has caused the COVID-19 pandemic) on Regenerons business and its employees, collaborators, and suppliers and other third parties on which Regeneron relies, Regenerons and its collaborators ability to continue to conduct research and clinical programs, Regenerons ability to manage its supply chain, net product sales of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, Regenerons Products), and the global economy; the nature, timing, and possible success and therapeutic applications of Regenerons Products and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, Regenerons Product Candidates) and research and clinical programs now underway or planned, including without limitation Dupixent (dupilumab); uncertainty of the utilization, market acceptance, and commercial success of Regenerons Products (such as Dupixent) and Regenerons Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary), including the study discussed in this press release, on any of the foregoing or any potential regulatory approval of Regenerons Products (such as Dupixent) and Regenerons Product Candidates; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regenerons Product Candidates and new indications for Regenerons Products, such as Dupixent for the treatment of chronic obstructive pulmonary disease with evidence of type 2 inflammation, hand and foot atopic dermatitis, pediatric eosinophilic esophagitis, bullous pemphigoid, prurigo nodularis, chronic spontaneous urticaria, chronic pruritis of unknown origin, chronic inducible urticaria-cold, chronic rhinosinusitis without nasal polyposis, allergic fungal rhinosinusitis, allergic bronchopulmonary aspergillosis, and other potential indications; the ability of Regenerons collaborators, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regenerons Products and Regenerons Product Candidates; the ability of Regeneron to manage supply chains for multiple products and product candidates; safety issues resulting from the administration of Regenerons Products (such as Dupixent) and Regenerons Product Candidates in patients, including serious complications or side effects in connection with the use of Regenerons Products and Regenerons Product Candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict Regenerons ability to continue to develop or commercialize Regenerons Products and Regenerons Product Candidates, including without limitation Dupixent; ongoing regulatory obligations and oversight impacting Regenerons Products, research and clinical programs, and business, including those relating to patient privacy; the availability and extent of reimbursement of Regenerons Products from third-party payers, including private payer healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payers and new policies and procedures adopted by such payers; competing drugs and product candidates that may be superior to, or more cost effective than, Regenerons Products and Regenerons Product Candidates; the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license or collaboration agreement, including Regenerons agreements with Sanofi, Bayer, and Teva Pharmaceutical Industries Ltd. (or their respective affiliated companies, as applicable), to be cancelled or terminated; and risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA (aflibercept) Injection, Dupixent, Praluent (alirocumab), and REGEN-COV (casirivimab and imdevimab)), other litigation and other proceedings and government investigations relating to the Company and/or its operations, the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regenerons business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regenerons filings with the U.S. Securities and Exchange Commission, including its Form 10-K for the fiscal year ended December 31, 2021 and its Form 10-Q for the quarterly period ended June 30, 2022. Any forward-looking statements are made based on managements current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise. Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regenerons media and investor relations website (http://newsroom.regeneron.com) and its Twitter feed (http://twitter.com/regeneron). Attachment Source: West Corporation Aug 31, 2022: Banco Santander Press Release: XenpozymeTM (olipudase alfa-rpcp) approved by FDA as first disease-specific treatment for ASMD (non-CNS manifestations) XenpozymeTM (olipudase alfa-rpcp) approved by FDA as first disease-specific treatment for ASMD (non-CNS manifestations) Paris, August 31, 2022. The U.S. Food and Drug Administration (FDA) has approved XenpozymeTM (olipudase alfa-rpcp) for the treatment of non-central nervous system (non-CNS) manifestations of acid sphingomyelinase deficiency (ASMD) in adult and pediatric patients. Xenpozyme is the first therapy indicated specifically for the treatment of ASMD, and is currently the only approved treatment for this disease. Bill SiboldExecutive Vice President, Head, Specialty Care at Sanofi Sanofi teams have been dedicated to bringing hope to patients living with ASMD and their families. This is a devastating and extremely rare disease that affects both children and adults. The approval of Xenpozyme represents the culmination of bold work done in research and development, and our unwavering commitment to this historically overlooked community. ASMD, historically known as Niemann-Pick disease types A, A/B, and B, is an extremely rare, progressive genetic disease with significant morbidity and mortality. It has been estimated that there are fewer than 120 patients diagnosed with ASMD in the U.S. Approximately two-thirds of patients with ASMD in the U.S. are pediatric. Signs and symptoms of ASMD can present in infancy, childhood, or adulthood, and may include enlarged spleen or liver, difficulty breathing, lung infections, and unusual bruising or bleeding, among other disease manifestations. Until now, management of ASMD included supportive care to address the impact of individual symptoms and careful monitoring to detect potential disease complications. David GuyParent to Kaila, age 16, living with ASMDAs young parents, it was initially devastating to me and my wife when our daughter, Kaila, received her diagnosis of ASMD. We faced so many unknowns when we first heard the diagnosis: what does this mean, how will this affect her, and most importantly what hope is there for a treatment option? We were grateful to find hope when we enrolled Kaila in the clinical trials for olipudase alfa. In the U.S., Xenpozyme received Breakthrough Therapy designation, which expedites the development and review of drugs intended to treat serious or life-threatening diseases and conditions. The FDA evaluated Xenpozyme under Priority Review, which is reserved for medicines that represent potentially significant improvements in efficacy or safety in treating serious conditions.. In March 2022, Xenpozyme was approved in Japan under the SAKIGAKE (or pioneer) designation, marking the first approval for olipudase alfa anywhere in the world. In June 2022, the European Commission (EC) approved Xenpozyme for use in Europe. ASMD represents a spectrum of disease, with two types that may represent opposite ends of a continuum referred to as ASMD type A and ASMD type B. ASMD type A/B is an intermediate form that includes varying degrees of central nervous system (CNS) involvement. ASCEND and ASCEND-Peds clinical trials showed that Xenpozyme improved lung function and reduced spleen and liver volumes in adults and children The approval is based on positive data from the ASCEND and ASCEND-Peds clinical trials, in which Xenpozyme showed clinically relevant improvement in lung function (as measured by diffusing capacity of the lung for carbon monoxide, or DLco) and platelet count, and reduction of spleen and liver volumes, with a demonstrated safety profile. Melissa WassersteinMD, Pediatric Genetic Medicine, Albert Einstein College of Medicine and the Childrens Hospital at MontefioreASMD is an extremely rare, progressive, and potentially fatal genetic disease that impacts children and adults around the world. Until now, those living with ASMD have had no FDA-approved treatment to combat this devastating condition. Im proud of the work that has been done and look forward to witnessing the impact that this treatment may have on those living with ASMD. The ASCEND trial evaluated the efficacy and safety of Xenpozyme; 31 adult patients with ASMD type A/B or type B were randomized to receive Xenpozyme or placebo for 52 weeks (primary analysis). In the trial, Xenpozyme improved lung function, assessed as the percent change from baseline to Week 52 in predicted diffusing capacity of the lung for carbon monoxide (DLco), and reduced spleen volume, evaluated as percent change from baseline in multiples of normal (MN). Twelve (12) patients treated with Xenpozyme had a mean change in percent predicted DLco from baseline (49.1%) to Week 52 (59.4%). This change represents a 23.9% relative improvement compared to a 3% improvement in DLco from baseline in the 17 patients from the placebo group (48.5%) to Week 52 (49.9%). The difference between the two arms (20.9%) was nominally statistically significant (p=0.0003).Thirteen (13) patients treated with Xenpozyme had a mean reduction in spleen volume by 38.9% from baseline (11.5 MN) to Week 52 (7.2 MN) compared to a mean increase by 0.5% for the 17 patients in the placebo group from baseline (11.2 MN) to Week 52 (11.2 MN). The difference between the two arms (39.4%) was nominally statistically significant (p<0.0001).Twelve (12) patients treated with Xenpozyme had a mean reduction in liver volume by 26.5% from baseline (1.4 MN) to Week 52 (1.0 MN) compared to a mean decrease of 1.8% for the 17 patients in the placebo group from baseline (1.6 MN) to Week 52 (1.6 MN). The difference between the two arms (24.7%) was nominally statistically significant (p<0.0001).Thirteen (13) patients treated with Xenpozyme had a mean improvement in platelet count by 18.3% from baseline (109.3x109/L) to Week 52 (126.4x109/L) compared to increase by 2.7% for the 16 patients in the placebo group from baseline (115.6x109/L) to Week 52 (120.2x109/L). The difference between the two arms (15.6%) was nominally statistically significant (p=0.0280).All ASCEND patients treated with Xenpozyme showed improvement in key endpoints (DLco and spleen and liver volume).Most frequently reported adverse drug reactions in adults (incidence 10%) were headache, cough, diarrhea, hypotension, and ocular hyperemia. The single-arm ASCEND-Peds trial studied 8 pediatric patients younger than 12 years of age with ASMD type A/B or type B who all received Xenpozyme, with a primary objective of evaluating the safety and tolerability of Xenpozyme for 64 weeks. All patients completed the study and continued in an extension trial. The ASCEND-Peds trial also explored efficacy endpoints of progressive lung disease, spleen and liver enlargement, and platelet count. After one year of treatment (52 weeks): Three (3) patients who were able to perform the test at baseline treated with Xenpozyme had a mean relative improvement of 45.9% in percent predicted DLco from baseline (48.5%) to Week 52 (70.9%) (children over the age of five were assessed if they were able to perform the test).Eight (8) patients treated with Xenpozyme had mean reduction in spleen volume by 46.7% from baseline (18.3 MN) to Week 52 (9.5 MN).Eight (8) patients treated with Xenpozyme had a mean reduction in liver volume by 38.1% from baseline (2.5 MN) to Week 52 (1.6 MN).Seven (7) patients treated with Xenpozyme had a mean improvement in platelet count by 37.6% from baseline (136.7x109/L; n=8) to Week 52 (184.5x109/L).Serious adverse reactions of anaphylactic reaction were reported in 2 (25%) Xenpozyme-treated pediatric patients. Treatment-related serious adverse reactions, hypersensitivity reactions including anaphylaxis, and infusion associated reactions occurred within 24 hours of infusion and were observed in a higher percentage of pediatric patients than in adult patients.Most frequently reported adverse drug reactions in pediatric patients (incidence 20%) were pyrexia, cough, diarrhea, rhinitis, abdominal pain, vomiting, headache, urticaria, nausea, rash, arthralgia, pruritus, fatigue, and pharyngitis. A scientific innovation for patients living with ASMD Xenpozyme, a hydrolytic lysosomal sphingomyelin-specific enzyme replacement therapy, is designed to replace deficient or defective acid sphingomyelinase (ASM), an enzyme that allows for the breakdown of the lipid sphingomyelin. In individuals with ASMD, the deficiency in the ASM enzyme leads to sphingomyelin accumulation in various tissues. Xenpozyme is not expected to cross the blood-brain barrier or modulate CNS manifestations of ASMD. Xenpozyme has not been studied in patients with ASMD type A. Xenpozyme is adminstered intravenously every two weeks, and its administration requires a dose escalation phase followed by a maintenance phase. Xenpozyme is expected to be available in the U.S. in the coming weeks. The U.S. list price, or wholesale acquisition cost, of Xenpozyme is $7,142.00 per vial. Actual patient out-of-pocket costs may be lower, as the list price does not reflect insurance coverage, co-pay support for eligible patients, or financial assistance from patient support programs. Sanofi is committed to helping eligible U.S. patients access the support they need and to help reduce barriers throughout their treatment journey. As part of its commitment to treatment access and affordability for innovative therapies, Sanofi provides disease education, financial and co-pay assistance programs, and other support services to eligible patients. For more information, patients can call 1-800-745-4447 and select Option 3, contact Info@CareConnectPSS.com, or visit www.Xenpozyme.com. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions.Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Media RelationsSandrine Guendoul|+ 33 6 25 09 14 25 |sandrine.guendoul@sanofi.comSally Bain|+ 1 617 834 6026 |sally.bain@sanofi.comKate Conway|+ 1 508 364 4931| kate.conway@sanofi.com Investor RelationsEva Schaefer-Jansen|+ 33 7 86 80 56 39 |eva.schaefer-jansen@sanofi.comArnaud Delepine|+ 33 6 73 69 36 93 | arnaud.delepine@sanofi.comCorentine Driancourt|+ 33 6 40 56 92 21 | corentine.driancourt@sanofi.comFelix Lauscher|+ 1908612 7239 | felix.lauscher@sanofi.comPriya Nanduri|+ 1 617 764 6418 | priya.nanduri@sanofi.com Nathalie Pham|+ 33 7 85 93 30 17 | nathalie.pham@sanofi.com Sanofi Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements are generally identified by the words "expects", "anticipates", "believes", "intends", "estimates", "plans" and similar expressions. Although Sanofi's management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actualresults and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including future clinical data andanalysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. Any material effect of COVID-19 on any of the foregoing could also adversely impact us. This situation is changing rapidly and additional impacts may arise of which we are not currently aware and may exacerbate other previously identified risks. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in Sanofi's annual report on Form 20-F for the year ended December 31, 2021. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. Attachment Source: West Corporation Aug 30, 2022: Banco Santander Press Release: FDA grants priority review to efanesoctocog alfa for people with hemophilia A FDA grants priority review to efanesoctocog alfa for people with hemophilia A The FDA decision date for efanesoctocog alfa, an investigational factor VIII therapy, is set for February 28, 2023Priority review based on pivotal data from the XTEND-1 Phase 3 studyEfanesoctocog alfa delivers high sustained factor activity levels in the normal to near-normal range for the majority of the week with once weekly prophylaxis dosing, providing higher protection for longer Paris and Stockholm August 30, 2022 The U.S. Food and Drug Administration (FDA) has accepted for priority review the Biologics License Application (BLA) for efanesoctocog alfa (BIVV001) for the treatment of hemophilia A, a rare and life-threatening bleeding disorder. The target action date for the FDA decision is February 28, 2023. Sanofi and Sobi collaborate on the development and commercialization of efanesoctocog alfa. Steve Pipe, MDProfessor and Director of Pediatric Hemophilia and Coagulation Disorders Program, University of Michigan Factor therapy remains a cornerstone of hemophilia treatment, but innovation has been needed in this area to address challenges related to bleed protection and cumbersome treatment regimens. If approved, efanesoctocog alfa can deliver close to normal factor activity levels for the majority of the week, potentially offering a new tier of protection. Such therapeutic benefits would represent important advances in unmet medical needs for people with hemophilia A and may transform the prophylactic treatment landscape. The BLA is supported by data from the pivotal XTEND-1 Phase 3 study. Results were recently presented at the 30th International Society of Thrombosis and Haemostasis Congress. The data demonstrate a clinically meaningful prevention of bleeds and superiority to prior factor prophylaxis based on an intra-patient comparison. Efanesoctocog alfa was well-tolerated, and inhibitor development to factor VIII was not detected. The most common treatment-emergent adverse events (>5% of participants overall) were headache, arthralgia, fall, and back pain. Dietmar Berger, MD, PhDGlobal Head of Development and Chief Medical Officer at Sanofi The results from the pivotal XTEND-1 Phase 3 study demonstrate efanesoctocog alfas ability to reduce annualized bleeding rates, which supports its potential as a therapy with best-in-disease efficacy. We look forward to working closely with the FDA during the review process as we aim to bring this novel therapy to the hemophilia A community. The FDA grants priority review to therapies that have the potential to provide significant improvements in the treatment, diagnosis, or prevention of serious conditions. Efanesoctocog alfa received Breakthrough Therapy designation from the FDA in May 2022 and it is the first factor VIII therapy to receive this recognition. The FDA also granted efanesoctocog alfa Orphan Drug designation in August 2017 and Fast Track designation in February 2021. Regulatory submission in the EU will follow availability of data from the ongoing XTEND-Kids pediatric study, with both events expected in 2023. The European Commission granted efanesoctocog alfa Orphan Drug designation in June 2019. About Phase 3 XTEND-1 Study (NCT04161495)The Phase 3 XTEND-1 study (NCT04161495)wasan open-label, non-randomized interventional study assessing the safety, efficacy and pharmacokinetics ofonce-weeklyefanesoctocog alfa in people 12 years of age or older (n=159) with severe hemophilia A who were previously treated with factor VIII replacement therapy.The study consisted of two parallel treatment arms the prophylaxis Arm A (n=133), in which patients who had received prior factor VIII prophylaxis were treated with once-weekly intravenousefanesoctocog alfa prophylaxis(50 IU/kg) for 52 weeks, and the on-demand Arm B (n=26), in which patients who had received prior on-demand factorVIIItherapy began 26 weeks of on-demandefanesoctocog alfa(50 IU/kg), then switched to once-weekly prophylaxis (50 IU/kg) for an additional 26 weeks. The primary efficacy endpoint was theannualized bleeding rate (ABR)in Arm A, and the key secondary endpoint was an intra-patient comparison of ABR during the efanesoctocog alfa weekly prophylaxis treatment period versus the priorfactor VIIIprophylaxis ABR for participants in Arm A whohadparticipatedin a previous observational study (Study 242HA201/OBS16221). About hemophilia AHemophilia A is a rare, genetic disorder in which the ability of a persons blood to clot is impaired due to a lack of factor VIII. Hemophilia A occurs in about one in 5,000 male births annually, and more rarely in females. People with hemophilia can experience bleeding episodes that can cause pain, irreversible joint damage and life-threatening hemorrhages. Factor replacement therapy remains a cornerstone of care and can be used across multiple treatment scenarios. About efanesoctocog alfa (BIVV001)Efanesoctocog alfa is a novel and investigational recombinant factor VIII therapy that is designed to extend protection from bleeds with once-weekly prophylactic dosing for people with hemophilia A. It builds on the innovative Fc fusion technology by adding a region of von Willebrand factor and XTEN polypeptides to extend its time in circulation. It is the first investigational factor VIII therapy that has been shown to break through the von Willebrand factor ceiling, which imposes a half-life limitation on current factor VIII therapies. Efanesoctocog alfa is currently under clinical investigation and its safety and efficacy have not been evaluated by any regulatory authority. About the Sanofi and Sobi collaborationSobi and Sanofi collaborate on the development and commercialization of Alprolixand Elocta/Eloctate.The companies also collaborate on the development and commercialization of efanesoctocog alfa. Sobi has final development and commercialization rights in the Sobi territory (essentially Europe, North Africa, Russia and most Middle Eastern markets). Sanofi has final development and commercialization rights in North America and all other regions in the world excluding the Sobi territory. About SobiSobi is a specialized international biopharmaceutical company transforming the lives of people with rare diseases. Providing sustainable access to innovative medicines in the areas of haematology, immunology and specialty care, Sobi has approximately 1,600 employees across Europe, North America, the Middle East and Asia. In 2021, revenue amounted to SEK 15.5 billion. Sobis share (STO:SOBI) is listed on Nasdaq Stockholm. More about Sobi at sobi.com,LinkedInandYouTube. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY. Sanofi Contacts:Media RelationsSandrine Guendoul|+ 33 6 25 09 14 25 |sandrine.guendoul@sanofi.comSally Bain|+ 1 617 834 6026 |sally.bain@sanofi.comKate Conway|+ 1508364 4931 |kate.conway@sanofi.com Investor RelationsEva Schaefer-Jansen|+ 33 7 86 80 56 39 |eva.schaefer-jansen@sanofi.comArnaud Delepine|+ 33 6 73 69 36 93 | arnaud.delepine@sanofi.comCorentine Driancourt|+ 33 6 40 56 92 21 | corentine.driancourt@sanofi.comFelix Lauscher|+ 1908612 7239 | felix.lauscher@sanofi.comPriya Nanduri|+ 1 617 764 6418 | priya.nanduri@sanofi.com Nathalie Pham|+ 33 7 85 93 30 17 | nathalie.pham@sanofi.com Sobi Contacts:Media RelationsFor Sobi Media contacts, click here. Investor RelationsFor details on how to contact the Sobi Investor Relations Team, click here. Sanofi Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words expects, anticipates, believes, intends, estimates, plans and similar expressions. Although Sanofis management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofis ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. Any material effect of COVID-19 on any of the foregoing could also adversely impact us. This situation is changing rapidly and additional impacts may arise of which we are not currently aware and may exacerbate other previously identified risks. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under Risk Factors and Cautionary Statement Regarding Forward-Looking Statements in Sanofis annual report on Form 20-F for the year ended December 31, 2021. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. Attachment Source: West Corporation Aug 17, 2022: Banco Santander Press Release: Sanofi provides update on amcenestrant clinical development program Sanofi provides update on amcenestrant clinical development program PARIS, August 17, 2022. Sanofi is discontinuing the global clinical development program of amcenestrant, an investigational oral selective estrogen receptor degrader (SERD). The decision is based on the outcome of a prespecified interim analysis of the Phase 3 AMEERA-5 trial evaluating amcenestrant in combination with palbociclib compared with letrozole in combination with palbociclib in patients with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer. An Independent Data Monitoring Committee (IDMC) found that amcenestrant in combination with palbociclib did not meet the prespecified boundary for continuation in comparison with the control arm and recommended stopping the trial. No new safety signals were observed. Trial participants will be transitioned to letrozole in combination with palbociclib or another appropriate standard of care therapy, as determined by their physician. The company will continue to review the data and plans to share the results with the scientific community in the future. All other studies of amcenestrant, including in early-stage breast cancer (AMEERA-6), will be discontinued. John Reed, MD, PhDGlobal Head of Research and Development at SanofiWhile we are disappointed by this outcome, our research will further the scientific understanding of endocrine therapies in people with breast cancer. Our sincere gratitude goes to the patients, families and healthcare professionals involved in the amcenestrant clinical development program. Oncology remains a priority area for Sanofi, and we will continue to pursue transformative research to develop new medicines for people living with cancer. In March, Sanofi announced that the Phase 2 AMEERA-3 trial had not met the primary endpoint of improving progression-free survival in patients with ER+/HER2- advanced or metastatic breast cancer. About AMEERA-5AMEERA-5 is a randomized, double-blind Phase 3 trial evaluating the efficacy and safety of amcenestrant in combination with palbociclib, a CDK4/6 inhibitor, in the first-line treatment of patients with ER+/HER2- advanced breast cancer. A total of 1068 patients who had not received any prior systemic anticancer therapies for advanced disease were randomized 1:1 to receive either amcenestrant or letrozole in combination with palbociclib. About AMEERA-6AMEERA-6 is a randomized, double-blind Phase 3 trial evaluating the efficacy and safety of amcenestrant compared with tamoxifen in patients with hormone receptor-positive early breast cancer who have discontinued adjuvant aromatase inhibitor (AI) therapy due to treatment related toxicity. The trial was initiated in partnership with the Breast International Group (BIG), the European Organization for Research and Treatment of Cancer (EORTC), and the Alliance Foundation Trials (AFT). About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Media RelationsEvan Berland|+ 1 215 432 0234 |evan.berland@sanofi.comKate Conway | +1 508 364 4931 | kate.conway@sanofi.com Investor RelationsEva Schaefer-Jansen|+ 33 7 86 80 56 39 |eva.schaefer-jansen@sanofi.comArnaud Delepine|+ 33 6 73 69 36 93 | arnaud.delepine@sanofi.comCorentine Driancourt|+ 33 6 40 56 92 21 | corentine.driancourt@sanofi.comFelix Lauscher|+ 1908612 7239 | felix.lauscher@sanofi.comPriya Nanduri|+ 1 617 764 6418 | priya.nanduri@sanofi.com Nathalie Pham|+ 33 7 85 93 30 17 | nathalie.pham@sanofi.com Disclaimers or Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words expects, anticipates, believes, intends, estimates, plans and similar expressions. Although Sanofis management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofis ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. Any material effect of COVID-19 on any of the foregoing could also adversely impact us. This situation is changing rapidly and additional impacts may arise of which we are not currently aware and may exacerbate other previously identified risks. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under Risk Factors and Cautionary Statement Regarding Forward-Looking Statements in Sanofis annual report on Form 20-F for the year ended December 31, 2021. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. Attachment Source: West Corporation Aug 04, 2022: Banco Santander Press Release: Sanofi and Innovent Biologics enter strategic collaboration to accelerate development of oncology medicines and expand presence in China Sanofi and Innovent Biologics enter strategic collaboration to accelerate development of oncology medicines and expand presence in China Collaboration to accelerate the development and access of oncology medicines for cancer patients in ChinaClinical trial programs combining two of Sanofis prioritized oncology assets with sintilimab, the leading checkpoint inhibitor in China, to address some of the most prevalent solid tumors in China Sanofi to make an initial equity investment of 300 million in Innovent in addition to the strategic multi-product collaborationThis strategic partnership demonstrates Sanofi and Innovents commitment to bringing high quality oncology medicines to patients in China Paris, August 4, 2022. Sanofi and Innovent Biologics (HKEX: 1801.HK, Innovent) announced a collaboration to bring innovative medicines to patients in China with difficult-to-treat cancers. Innovent is a leading biopharmaceutical company with strong clinical development capabilities and a broad commercial footprint in China. Both companies are committed to accelerating the development and commercialization of two Sanofi key clinical stage oncology assets: Phase III SAR408701 (tusamitamab ravtansine; anti-CEACAM5 antibody-drug conjugate) and Phase II SAR444245 (non-alpha IL-2), combining with sintilimab, the leading checkpoint inhibitor in China. In addition to the collaboration and license agreement, Sanofi will invest 300 million in Innovent through subscription of new common shares. John Reed, M.D., Ph.D.Global Head of Research and Development at Sanofi This strategic collaboration with Innovent will not only accelerate the development, market access and future commercialization of two of our key oncology medicines in selected combinations with sintilimab, but also bolster our overall presence in oncology in China. We look forward to a successful partnership with Innovent, one of the most innovative companies in China, and to leveraging their development capabilities and market leadership in the country. Michael Yu, Ph.D.Founder, Chairman and CEO of Innovent This strategic collaboration with Sanofi, a leading global pharmaceutical company, opens the pathway to great synergy for accelerating the pace of innovation. This pioneering partnership will leverage the synergy between Sanofi and Innovents pipeline and R&D resources with the mutual aim to address major unmet medical needs for cancer patients. We hope this agreement will be a great start of the two parties long-term partnership, and we look forward to bringing more innovative therapies to patients. Clinical development and commercialization of tusamitamab ravtansine SAR408701 (tusamitamab ravtansine) is a potential first-in-class antibody-drug conjugate (ADC) targeting CEACAM5 (carcinoembryonic antigen-related cell adhesion molecule 5), a cell-surface glycoprotein that is highly expressed in non-small cell lung cancer (NSCLC), gastric cancer and other cancers. SAR408701 is currently in a Phase 3 study for 2L NSCLC globally including China, and global Phase 2 studies in additional indications including 1L NSCLC, gastric cancers and other solid tumors. According to the agreement, Innovent will be responsible for developing and exclusively commercializing tusamitamab in multiple oncology-based indications in China. Sanofi will be entitled to receive up to 80 million development milestone payment and royalties on the net sales of the product in China upon approval. Clinical development and commercialization of SAR444245 SAR444245 is a potential first-in-class reprogrammed, site-directed, single PEGylated, recombinant human IL-2 (rIL-2) variant with extended half-life that specifically binds to the low-affinity IL-2 receptor but lacks binding affinity for the lpha chain of the high-affinity IL-2 receptor. SAR444245(IL-2) is currently under global Phase 2 studies for skin cancers, gastrointestinal cancer, NSCLC / mesothelioma, head and neck tumors, and lymphoma. Innovent and Sanofi will jointly explore the development of SAR444245 in China in various cancer types, where Innovent will lead the clinical development. Sanofi remains the sole Marketing Authorization holder for both assets and will be fully responsible for SAR245 commercialization. Innovent will be entitled to receive up to 60 million development milestone payments and royalties on the net sales of the product in China upon approval. Sanofis initial strategic equity investment in Innovent for 300 million In addition to the strategic multi-product collaboration and license agreement, Sanofi, subject to conditions precedent including regulatory approval and customary closing conditions, will invest in new common shares issued by Innovent for 300 million, at a price of HK $42.42 per share, representing a 20% premium to the Innovent 30-trading-day average share price as of August 3, 2022, one day prior to the signing of the agreements. Subject to mutual agreement of both parties in the future, Sanofi will have the right to acquire additional Innovent new common shares for 300 million, at a subscription price that represents 20% premium to Innovent 30-trading-day average share price as the date of the separate agreement that may be entered into by both parties. About SAR408701 SAR408701 (tusamitamab ravtansine) is a potential first-in-class antibody-drug conjugate (ADC) targeting CEACAM5 (carcinoembryonic antigen-related cell adhesion molecule 5), a cell-surface glycoprotein that is highly expressed in non-small cell lung cancer (NSCLC), gastric cancer and other cancers. Tusamitamab ravtansine is currently in a Phase 3 study for second-line NSCLC globally including China, and global Phase 2 studies in additional indications including first-line NSCLC, gastric cancers and other solid tumors. About SAR444245SAR444245 is a potential first-in-class recombinant human IL-2 (rIL-2) variant that includes a site-directed single PEG moiety/chain that prevents it from binding to the chain of the IL-2 receptor while retaining near-native affinity for the beta/gamma subunits. SAR444245 is currently being investigated in global Phase 2 studies for the treatment of skin cancers, gastrointestinal cancer, NSCLC / mesothelioma, head and neck tumors, and lymphoma. About Sintilimab (TYVYT)Sintilimab, marketed as TYVYT (sintilimab injection) in China, is a PD-1 immunoglobulin G4 monoclonal antibody jointly developed by Innovent and Eli Lilly and Company. Innovent is currently conducting more than 20 clinical studies of sintilimab to evaluate its safety and efficacy in a wide variety of cancer indications, including more than 10 registrational or pivotal clinical trials. In China, sintilimab has been approved for six indications including relapsed or refractory classic Hodgkins lymphoma, first-line treatment of non-squamous NSCLC, first-line treatment of squamous NSCLC, first-line treatment of hepatocellular carcinoma, first-line treatment of esophageal squamous cell carcinoma, and first-line treatment of gastric or gastroesophageal junction adenocarcinoma, of which the first four indications have been included in the National Reimbursement Drug List (NRDL). Note:SAR408701 and SAR444245 are not approved products in China About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions.Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY About Innovent Inspired by the spirit of "Start with Integrity, Succeed through Action, Innovents mission is to develop, manufacture and commercialize high-quality biopharmaceutical products that are affordable to ordinary people. Established in 2011, Innovent has developed a fully integrated multi-functional platform which includes R&D, CMC (Chemistry, Manufacturing, and Controls), clinical development and commercialization capabilities. Leveraging the platform, the company has built a robust pipeline of 34 valuable assets in the fields of cancer, autoimmune, metabolic, ophthalmology and other major therapeutic areas. On October 31, 2018, Innovent was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code: 01801.HK. For more information, please visit: www.innoventbio.com. and www.linkedin.com/company/innovent-biologics/. SanofiMedia RelationsSandrine Guendoul|+ 33 6 25 09 14 25 |sandrine.guendoul@sanofi.comSally Bain|+ 1 617 834 6026 |sally.bain@sanofi.comKate Conway|+ 1508 364 4931 |kate.conway@sanofi.com Investor RelationsEva Schaefer-Jansen|+ 33 7 86 80 56 39 |eva.schaefer-jansen@sanofi.comArnaud Delepine|+ 33 6 73 69 36 93 | arnaud.delepine@sanofi.comCorentine Driancourt|+ 33 6 40 56 92 21 | corentine.driancourt@sanofi.comFelix Lauscher|+ 1908612 7239 | felix.lauscher@sanofi.comPriya Nanduri| +1 617 764 6418 |priya.nanduri@sanofi.com Nathalie Pham|+ 33 7 85 93 30 17 | nathalie.pham@sanofi.com InnoventMedia | +86 512-6956 6088 | pr@innoventbio.comInvestors | +86 512-6956 6088 | ir@innoventbio.com Sanofi Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words expects, anticipates, believes, intends, estimates, plans and similar expressions. Although Sanofis management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofis ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. Any material effect of COVID-19 on any of the foregoingcould also adversely impact us. This situation is changing rapidly and additional impacts may arise of which we are not currently aware and may exacerbate other previously identified risks. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under Risk Factors and Cautionary Statement Regarding Forward-Looking Statements in Sanofis annual report on Form 20-F for the year ended December 31, 2021. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. Innovent Forward-Looking StatementsThis news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent Biologics, Inc. (Innovent or Company) , are intended to identify certain of such forward-looking statements. The Company does not intend to update these forward-looking statements regularly. These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of the Company with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond the Company's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, the Company's competitive environment and political, economic, legal and social conditions. The Company, the Directors and the employees of the Company assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialise or turn out to be incorrect. Attachment Press_Release Source: West Corporation Jul 28, 2022: Banco Santander Press Release: Online availability of Sanofis half-year financial report for 2022 Online availability of Sanofis half-year financial report for 2022 Paris, July 28, 2022. Sanofi announces that its half-year financial report for the period ending June 30, 2022 is now available and has been filed with the French market regulator Autorite des marches financiers (AMF) and submitted to the U.S. Securities and Exchange Commission (SEC) under form 6-K. This document may be found on the companys corporate website: www.sanofi.com and downloaded from the Investors page, under the heading Regulated Information in France. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Media RelationsSandrine Guendoul|+ 33 6 25 09 14 25 |sandrine.guendoul@sanofi.comNicolas Obrist|+ 33 6 77 21 27 55 |nicolas.obrist@sanofi.comVictor Rouault|+ 33 6 70 93 71 40 |victor.rouault@sanofi.com Investor RelationsEva Schaefer-Jansen|+ 33 7 86 80 56 39 |eva.schaefer-jansen@sanofi.comArnaud Delepine|+ 33 6 73 69 36 93 | arnaud.delepine@sanofi.comCorentine Driancourt|+ 33 6 40 56 92 21 | corentine.driancourt@sanofi.comFelix Lauscher|+ 1908612 7239 | felix.lauscher@sanofi.comPriya Nanduri| +1 617 764 6418 |priya.nanduri@sanofi.com Nathalie Pham|+ 33 7 85 93 30 17 | nathalie.pham@sanofi.com Attachment Press Release Source: West Corporation Jul 28, 2022: Banco Santander Press Release: Strong execution in Q2 drives full-year 2022 guidance upgrade and delivers rich R&D news flow in Immunology and Rare Disease Strong execution in Q2 drives full-year 2022 guidance upgrade and delivers rich R&D news flow in Immunology and Rare Disease Paris, July 28, 2022.Read the full press release Q2 2022 sales growth of 8.1% at CER driven by Dupixent, Rare Disease, Vaccines and CHC Q2 2022 business EPS(1) up 16.7% at CER driven by higher sales and improving margins Progress on Corporate Social Responsibility strategy Key milestone and regulatory achievements on R&D transformation Full-year 2022 business EPS guidance revised upward Sanofi Chief Executive Officer, Paul Hudson, commented: Our performance in the second quarter was again marked by higher sales across our key growth drivers and outstanding financial results leading us to upgrade our business EPS guidance for the full-year. Notably, we saw significant growth momentum from our Specialty Care business, mainly driven by Dupixent. While we continue to increase our investment in R&D, we delivered important pipeline milestones such as the approval of Dupixent in its fourth disease indication, Eosinophilic Esophagitis. Earlier this month, we had the opportunity to showcase at ISTH the transformative potential of efanesoctocog alfa, the first factor replacement therapy for hemophilia A to receive FDA Breakthrough Therapy Designation. We are also making great progress in advancing our fully integrated social impact strategy, notably in Affordable Access with the launch of Impact, a dedicated brand for non-profit distribution to enable the secure distribution of 30 Sanofi medicines in 40 lower-income countries. As we continue to deliver ahead of schedule on our Play to Win strategy, we are confident in our business outlook for the second half and as a result, we are reiterating our commitment to achieving the BOI margin target of 30% in 2022. Source: West Corporation Jul 14, 2022: Banco Santander Press Release: Dupixent (dupilumab) Phase 3 trial shows positive results in children 1 to 11 years of age with eosinophilic esophagitis Dupixent (dupilumab) Phase 3 trial shows positive results in children 1 to 11 years of age with eosinophilic esophagitis First and only investigational Phase 3 trial to show positive results in these young children; results follow recent approval of Dupixent in people with eosinophilic esophagitis aged 12 years and older who weigh at least 40 kilogramsTrial met its primary endpoint, with 68% of patients on higher dose Dupixent and 58% on lower dose Dupixent achieving histological disease remission at 16 weeksOf the approximately 21,000 children under the age of 12 in the U.S. currently being treated for EoE, about 9,000 do not satisfactorily respond to the unapproved therapies they have been treated withFifth pediatric pivotal trial across three type 2 inflammatory diseases to reinforce the well-established efficacy and safety profile of Dupixent Paris and Tarrytown, N.Y. July 14, 2022 A Phase 3 trial assessing the investigational use of Dupixent (dupilumab) in children aged 1 to 11 years with eosinophilic esophagitis (EoE) met its primary endpoint of histological disease remission at 16 weeks with both higher and lower dose weight-tiered regimens. There are no approved treatments for children with EoE under 12 years of age. Naimish Patel, M.D.Senior Vice President, Head of Global Development, Immunology and Inflammation, Sanofi We are incredibly excited to share results from this Phase 3 pivotal trial evaluating Dupixent in young children suffering from eosinophilic esophagitis the first ever to show positive results across a variety of primary and secondary endpoints. The lack of treatment options for children living with eosinophilic esophagitis leaves many caregivers with the stress and burden of adapting their childs meals and their entire familys daily schedules to ensure healthy growth and development. In some cases, they must resort to off-label use of poorly studied treatments like steroids that can pose serious health risks when used long term. The faster and larger than anticipated enrollment in this trial further emphasizes the unmet treatment needs for children with EoE and underscores the significance of these first-ever positive results. EoE is a chronic inflammatory disease that damages the esophagus and prevents it from working properly. The results seen with Dupixent in adults and children with EoE demonstrate that IL-4 and IL-13 are key drivers of the type 2 inflammation underlying this disease. In children, common symptoms of eosinophilic esophagitis include acid reflux, vomiting, abdominal discomfort, trouble swallowing, and a failure to thrive. These symptoms can impact growth and development, and can cause food-related fear and anxiety which can persist through adulthood. Diet adjustments, which oftentimes include the elimination of many foods, is the standard treatment for EoE, as well as the use of treatments not approved for the disease. These include proton pump inhibitors, swallowed topical corticosteroids, or in severe cases, a feeding tube, which may be used to ensure proper caloric intake and weight gain. Of the approximately 21,000 children under the age of 12 in the U.S. currently being treated for EoE, about 9,000 do not satisfactorily respond to the unapproved therapies they have been treated with and potentially require advanced therapy. George D. Yancopoulos, M.D., Ph.D.President and Chief Scientific Officer, RegeneronDupixent is the first medicine to alleviate key signs of eosinophilic esophagitis in children as young as 1 year of age in a Phase 3 trial. The efficacy of Dupixent demonstrates that, in this age group, as in adults, IL-4 and IL-13 are key drivers of the type 2 inflammation underlying this debilitating disease. Eosinophilic esophagitis can turn the basic and life-sustaining act of eating into a painful experience at a point in childrens lives when proper nutrition and achieving a healthy weight is critical to ensuring they grow and thrive. The positive results from this Phase 3 pediatric trial show Dupixent has the potential to improve signs of eosinophilic esophagitis and support healthy weight gain in children from their first birthday. In the Phase 3 trial, 102 children aged 1 to 11 were randomized to receive Dupixent, in either a higher dose (n=37) or lower dose (n=31) regimen based on body weight, or placebo (n=34). At 16 weeks, 68% of children on higher dose and 58% of patients on lower dose Dupixent achieved the primary endpoint of significant histological disease remission (peak esophageal intraepithelial eosinophil count of 6 eosinophils [eos]/high power field [hpf]) compared to 3% of children on placebo (p<0.0001 for both). Additionally, children receiving higher dose Dupixent experienced the following changes at week 16: 86% reduction in peak esophageal intraepithelial eosinophil count from baseline compared to a 21% increase for placebo (p<0.0001).0.88 and 0.84 reduction from baseline in disease severity and extent, respectively, as measured at the microscopic level in biopsy specimens compared to a 0.02 and 0.05 increase for placebo (both p<0.0001).3.5-point reduction in abnormal endoscopic findings from baseline compared to a 0.3-point increase for placebo (p<0.0001).A numerical improvement in the proportion of days children experienced symptoms of EoE from baseline, as reported by caregivers (Pediatric EOE signs/symptoms questionnaire [PESQ-C]), compared to placebo, though not statistically significant. The PESQ-C is a novel endpoint developed by Sanofi and Regeneron used for the first time in this trial, designed to assess symptoms in young children through their caregivers (as signs), as children may have difficulty verbalizing their symptoms themselves.As part of a prespecified exploratory analysis a 3.09 percentile increase in body weight for age percentile from baseline compared to 0.29 for placebo. Histological, anatomic and cellular secondary endpoints were also analyzed for the lower dose group, with all being nominally significant and generally comparable with the higher dose. More detailed results will be shared at an upcoming medical meeting, including additional data for the endpoints in the lower dose group. Safety results were generally consistent with the known safety profile of Dupixent in its approved EoE indication for children and adults aged 12 years and older who weigh at least 40 kg. For the 16-week treatment period, overall rates of adverse events (AEs) were 79% for Dupixent and 91% for placebo. AEs more commonly (5%) observed with Dupixent compared to placebo included COVID-19 (21% Dupixent, 0% placebo; all cases were mild or moderate and did not lead to study discontinuation), rash (9% Dupixent, 6% placebo), headache (8% Dupixent, 3% placebo), viral gastroenteritis (6% Dupixent, 3% placebo), diarrhea (6% Dupixent, 3% placebo) and nausea (6% Dupixent, 0% placebo). Rates of treatment discontinuation due to AEs prior to week 16 were 0% for Dupixent and 6% for placebo. In May 2022, the U.S. Food and Drug Administration (FDA) approved Dupixent 300 mg weekly to treat patients with EoE aged 12 years and older and weighing at least 40 kg after granting the medicine Priority Review. The potential use of Dupixent in children with EoE aged 1 to 11 years is currently under clinical development, and the safety and efficacy have not been fully evaluated by any regulatory authority. These data will be discussed with regulatory authorities around the world, starting with the U.S. later this year. About the Dupixent Pediatric Eosinophilic Esophagitis Trial The Phase 3, randomized, double-blind, placebo-controlled trial evaluated the efficacy and safety of Dupixent in young children aged 1 to 11 years with EoE, as determined by histological and patient- or caregiver-reported measures. At baseline, 98% of these patients had at least one co-existing type 2 inflammatory disease such as food allergy, allergic rhinitis, asthma and atopic dermatitis. Patients received Dupixent subcutaneously at either a higher dose or lower dose regimen based on their weight (ranging from 5 kg to <60 kg) over a 16-week period, at which point all endpoints were assessed. The dosing frequency ranged between every two weeks and every four weeks, based on weight. The primary endpoint was histological disease remission. Secondary endpoints included histopathologic measures of the severity and extent of tissue scarring in the esophagus (EoE-HSS grade and stage scores, which measure changes in eight cellular and tissue features on 0-3 scales, respectively), and abnormal endoscopic findings (EoE Endoscopic Reference Score [EoE-EREFS] on a 0-18 scale), as well as changes in caregiver-reported symptoms (proportion of days with 1 or more EoE signs [e.g. stomach pain, vomiting, food refusal] by the Pediatric EoE Sign/Symptom Questionnaire-caregiver version [PESQ-C]). An exploratory endpoint assessed change from baseline in body weight for age percentile. The trial is ongoing with a 36-week extended active treatment period to evaluate long-term outcomes. About Dupixent Dupixent is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not an immunosuppressant. The Dupixent development program has shown significant clinical benefit and a decrease in type 2 inflammation in Phase 3 trials, establishing that IL-4 and IL-13 are key and central drivers of the type 2 inflammation that plays a major role in multiple related and often co-morbid diseases. These diseases include approved indications for Dupixent such as asthma, atopic dermatitis, chronic rhinosinusitis with nasal polyposis (CRSwNP) and EoE, as well as investigational diseases such as prurigo nodularis. Dupixent has received regulatory approvals around the world for use in certain patients with atopic dermatitis, asthma, CRSwNP or EoE in different age populations. Dupixent is currently approved across these indications in the U.S. and for one or more of these indications in more than 60 countries, including in the European Union and Japan. More than 400,000 patients have been treated with Dupixent globally. Dupilumab Development Program Dupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement. To date, dupilumab has been studied across more than 60 clinical trials involving more than 10,000 patients with various chronic diseases driven in part by type 2 inflammation. In addition to the currently approved indications, Sanofi and Regeneron are studying dupilumab in a broad range of diseases driven by type 2 inflammation or other allergic processes in Phase 3 trials, including prurigo nodularis, pediatric EoE, hand and foot atopic dermatitis, chronic inducible urticaria-cold, chronic spontaneous urticaria, chronic pruritis of unknown origin, chronic obstructive pulmonary disease with evidence of type 2 inflammation, chronic rhinosinusitis without nasal polyposis, allergic fungal rhinosinusitis, allergic bronchopulmonary aspergillosis and bullous pemphigoid. These potential uses of dupilumab are currently under clinical investigation, and the safety and efficacy in these conditions have not been fully evaluated by any regulatory authority. About Regeneron Regeneron is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led for nearly 35 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous FDA-approved treatments and product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, hematologic conditions, infectious diseases and rare diseases. Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite technologies, such as VelocImmune, which uses unique genetically humanized mice to produce optimized fully human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world. For more information, please visit www.Regeneron.com or follow @Regeneron on Twitter. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY. Sanofi Media RelationsSally Bain|+ 1 617 834 6026 |sally.bain@sanofi.com Sanofi Investor RelationsEva Schaefer-Jansen | + 33 7 86 80 56 39 | eva.schaefer-jansen@sanofi.com Arnaud Delepine | + 33 06 73 69 36 93 | arnaud.delepine@sanofi.com Corentine Driancourt | + 33 06 40 56 92 | corentine.driancourt@sanofi.com Felix Lauscher | + 1 908 612 7239 | felix.lauscher@sanofi.com Priya Nanduri |+617 764 6418 | priya.nanduri@sanofi.com Nathalie Pham | + 33 07 85 93 30 17 | nathalie.pham@sanofi.com Regeneron Media RelationsSharon Chen | + 1 914 847 1546 | sharon.chen@regeneron.com Regeneron Investor RelationsVesna Tosic | + 914 847 5443 | vesna.tosic@regeneron.com Sanofi Disclaimers or Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words expects, anticipates, believes, intends, estimates, plans and similar expressions. Although Sanofis management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofis ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. Any material effect of COVID-19 on any of the foregoing could also adversely impact us. This situation is changing rapidly and additional impacts may arise of which we are not currently aware and may exacerbate other previously identified risks. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under Risk Factors and Cautionary Statement Regarding Forward-Looking Statements in Sanofis annual report on Form 20-F for the year ended December 31, 2021. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. Regeneron Forward-Looking Statements and Use of Digital Media This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. (Regeneron or the Company), and actual events or results may differ materially from these forward-looking statements. Words such as anticipate, expect, intend, plan, believe, seek, estimate, variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the impact of SARS-CoV-2 (the virus that has caused the COVID-19 pandemic) on Regenerons business and its employees, collaborators, and suppliers and other third parties on which Regeneron relies, Regenerons and its collaborators ability to continue to conduct research and clinical programs, Regenerons ability to manage its supply chain, net product sales of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, Regenerons Products), and the global economy; the nature, timing, and possible success and therapeutic applications of Regenerons Products and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, Regenerons Product Candidates) and research and clinical programs now underway or planned, including without limitation Dupixent (dupilumab); the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regenerons Product Candidates and new indications for Regenerons Products, such as Dupixent for the treatment of children aged 1 to 11 years with eosinophilic esophagitis as discussed in this press release as well as for the treatment of prurigo nodularis, hand and foot atopic dermatitis, chronic inducible urticaria-cold, chronic spontaneous urticaria, chronic pruritis of unknown origin, chronic obstructive pulmonary disease with evidence of type 2 inflammation, chronic rhinosinusitis without nasal polyposis, allergic fungal rhinosinusitis, allergic bronchopulmonary aspergillosis, bullous pemphigoid, and other potential indications; uncertainty of the utilization, market acceptance, and commercial success of Regenerons Products and Regenerons Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary), including the study discussed in this press release, on any of the foregoing or any potential regulatory approval of Regenerons Products and Regenerons Product Candidates (such as Dupixent); the ability of Regenerons collaborators, licensees, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regenerons Products and Regenerons Product Candidates; the ability of Regeneron to manage supply chains for multiple products and product candidates; safety issues resulting from the administration of Regenerons Products (such as Dupixent) and Regenerons Product Candidates in patients, including serious complications or side effects in connection with the use of Regenerons Products and Regenerons Product Candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict Regenerons ability to continue to develop or commercialize Regenerons Products and Regenerons Product Candidates, including without limitation Dupixent; ongoing regulatory obligations and oversight impacting Regenerons Products, research and clinical programs, and business, including those relating to patient privacy; the availability and extent of reimbursement of Regenerons Products from third-party payers, including private payer healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payers and new policies and procedures adopted by such payers; competing drugs and product candidates that may be superior to, or more cost effective than, Regenerons Products and Regenerons Product Candidates; the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators or licensees may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license, collaboration, or supply agreement, including Regenerons agreements with Sanofi, Bayer, and Teva Pharmaceutical Industries Ltd. (or their respective affiliated companies, as applicable) to be cancelled or terminated; and risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA (aflibercept) Injection, Dupixent, Praluent (alirocumab), and REGEN-COV (casirivimab and imdevimab)), other litigation and other proceedings and government investigations relating to the Company and/or its operations, the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regenerons business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regenerons filings with the U.S. Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2021 and its Form 10-Q for the quarterly period ended March 31, 2022. Any forward-looking statements are made based on managements current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise.Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regenerons media and investor relations website (http://newsroom.regeneron.com) and its Twitter feed (http://twitter.com/regeneron) Attachment Source: West Corporation Jul 10, 2022: Banco Santander Press Release: Pivotal data demonstrate once-weekly efanesoctocog alfa provides superior bleed protection compared to prior factor prophylaxis Pivotal data demonstrate once-weekly efanesoctocog alfa provides superior bleed protection compared to prior factor prophylaxis Investigational once-weekly efanesoctocog alfa prophylaxis met the primary efficacy endpoint providing clinically meaningful bleed protection for people with severe hemophilia AResults underscore the ability of efanesoctocog alfa to sustain normal to near-normal factor levels and the potential to transform prophylactic treatment, providing people with hemophilia A with higher protection for longerAdditional data showed efanesoctocog alfa prophylaxis resulted in statistically significant and clinically meaningful improvements in physical health, pain intensity and joint health in patients on prior factor VIII prophylaxis Paris and Stockholm July 10, 2022 Sanofi and Swedish Orphan Biovitrum AB (publ) (Sobi) (STO:SOBI) presented for the first time today, in a late-breaking session at the 30th International Society on Thrombosis and Haemostasis (ISTH) Congress, positive results from the XTEND-1 pivotal Phase 3 study evaluating the safety, efficacy and pharmacokinetics of efanesoctocog alfa (BIVV001), an investigational factor VIII replacement therapy, in previously treated adults and adolescents 12 years with severe hemophilia A. The study met the primary efficacy endpoint, with once-weekly efanesoctocog alfa prophylaxis providing clinically meaningful bleed protection for people with severe hemophilia A. The median and mean annualized bleeding rates (ABR) were 0.00 (IQR: 0.00-1.04) and 0.71 (SD: 1.43) respectively. The study also met the key secondary endpoint, demonstrating superior bleed protection (p<0.0001) over prior factor VIII prophylaxis with an estimated ABR reduction of 77% and a mean ABR of 0.69 compared to 2.96 on prior prophylaxis, based on an intra-patient comparison (n=78). In a subset of participants (n=17) studied at baseline and week 26, mean factor VIII levels remained in the normal to near-normal range (>40 IU/dL) for the majority of the week, and at 15 IU/dL at Day seven post-dose, providing increased factor activity level protection for patients with once-weekly prophylaxis. Annette von Drygalski, MD, PharmDInvestigator, Professor and Director, Hemophilia and Thrombosis Treatment Center, UC San DiegoThe phase 3 data demonstrate once-weekly efanesoctocog alfas potential to provide superior bleed protection, leading to substantial improvements in physical health, pain and joint health, by sustaining high factor levels for the majority of the week. These unprecedented results may offer people with hemophilia A the possibility to redefine their treatment expectations. Data show adults and adolescents treated with once-weekly efanesoctocog alfa experienced statistically significant and clinically meaningful improvements in physical health (p=0.0001), pain intensity (p=0.0276), and joint health (p=0.0101) when comparing week 52 and baseline measurements.i Moreover, efanesoctocog alfa was effective at treating bleeds, including in target joints; 96.7% of bleeds were resolved with a single 50 IU/kg dose. Efanesoctocog alfa was well tolerated and inhibitor development to factor VIII was not detected. The most common treatment-emergent adverse events (>5% of participants overall) were headache, arthralgia, fall, and back pain. Dietmar Berger, MD, PhDGlobal Head of Development and Chief Medical Officer, Sanofi We are committed to advancing innovative medicines that disrupt the status-quo and address the unmet needs that persist for people with rare conditions like hemophilia. These robust data illustrate the promise of efanesoctocog alfas efficacy with once-weekly dosing and underscore its potential as a therapy with best-in-disease efficacy. Anders Ullman, MD, PhDHead of R&D and Chief Medical Officer, Sobi We believe transforming the treatment paradigm for hemophilia A can only be achieved through elevating standards of care towards normal hemostasis. These data demonstrate the profile of efanesoctocog alfa in significant clinical terms, and further strengthen its potential to ultimately improve the lives of many living with this condition. The U.S Food and Drug Administration (FDA) granted efanesoctocog alfa Breakthrough Therapy Designation in May 2022, Fast Track designation in February 2021 and Orphan Drug designation in August 2017. The European Commission also granted efanesoctocog alfa Orphan Drug designation in June 2019. Regulatory submission of the Biologics License Application to the U.S. FDA occurred in June 2022 and submission in the EU will follow availability of data from the ongoing XTEND-Kids pediatric study, expected in 2023. About Phase 3 XTEND-1 Study (NCT04161495)The Phase 3 XTEND-1 study (NCT04161495) was an open-label, non-randomized interventional study assessing the safety, efficacy and pharmacokinetics of once-weekly efanesoctocog alfa in people 12 years of age or older (n=159) with severe hemophilia A who were previously treated with factor VIII replacement therapy. The study consists of two parallel treatments arms the prophylaxis Arm A (n=133), in which patients who had received prior factor VIII prophylaxis began receiving once-weekly intravenous efanesoctocog alfa prophylaxis (50 IU/kg) for 52 weeks, and the on-demand Arm B (n=26), in which patients who had received prior on-demand factor VIII therapy began 26 weeks of on-demand efanesoctocog alfa (50 IU/kg), then switched to once-weekly prophylaxis (50 IU/kg) for an additional 26 weeks. The primary efficacy endpoint was the ABR in Arm A, and the key secondary endpoint was an intra-patient comparison of ABR during the efanesoctocog alfa weekly prophylaxis treatment period versus the prior factor VIII prophylaxis ABR for participants in Arm A who had participated in a previous observational study (Study 242HA201/OBS16221). About hemophilia AHemophilia A is a rare, genetic disorder in which the ability of a persons blood to clot is impaired due to a lack of factor VIII. Hemophilia A occurs in about one in 5,000 male births annually, and more rarely in females. People with hemophilia can experience bleeding episodes that can cause pain, irreversible joint damage and life-threatening hemorrhages. Factor replacement therapy remains a cornerstone of care and can be used across multiple treatment scenarios. About efanesoctocog alfaEfanesoctocog alfa, formerly BIVV001, is a novel and investigational recombinant factor VIII therapy that is designed to extend protection from bleeds with once-weekly prophylactic dosing for people with hemophilia A. It builds on the innovative Fc fusion technology by adding a region of von Willebrand factor and XTEN polypeptides to extend its time in circulation. It is the first investigational factor VIII therapy that has been shown to break through the von Willebrand factor ceiling, which imposes a half-life limitation on current factor VIII therapies. Efanesoctocog alfa is currently under clinical investigation and its safety and efficacy have not been evaluated by any regulatory authority. About the Sanofi and Sobi collaborationSobi and Sanofi collaborate on the development and commercialization of Alprolix and Elocta/Eloctate.The companies also collaborate on the development and commercialization of efanesoctocog alfa, an investigational factor VIII therapy with the potential to provide high sustained factor activity levels with once-weekly dosing for people with hemophilia A. Sobi has final development and commercialization rights in the Sobi territory (essentially Europe, North Africa, Russia and most Middle Eastern markets). Sanofi has final development and commercialization rights in North America and all other regions in the world excluding the Sobi territory. About SobiSobi is a specialised international biopharmaceutical company transforming the lives of people with rare diseases. Providing sustainable access to innovative medicines in the areas of haematology, immunology and specialty care, Sobi has approximately 1,600 employees across Europe, North America, the Middle East and Asia. In 2021, revenue amounted to SEK 15.5 billion. Sobis share (STO:SOBI) is listed on Nasdaq Stockholm. More about Sobi at sobi.com, LinkedIn and YouTube. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Media RelationsSandrine Guendoul|+ 33 6 25 09 14 25 |sandrine.guendoul@sanofi.comSally Bain|+ 1 617 834 6026 |sally.bain@sanofi.comKate Conway|+ 1508364 4931 |lisa.zobel@sanofi.com Investor RelationsEva Schaefer-Jansen|+ 33 7 86 80 56 39 |eva.schaefer-jansen@sanofi.comArnaud Delepine|+ 33 6 73 69 36 93 | arnaud.delepine@sanofi.comCorentine Driancourt|+ 33 6 40 56 92 21 | corentine.driancourt@sanofi.comFelix Lauscher|+ 1908612 7239 | felix.lauscher@sanofi.comPriya Nanduri|+1 617 764 6418 | priya.nanduri@sanofi.com Nathalie Pham|+ 33 7 85 93 30 17 | nathalie.pham@sanofi.com Sobi Contacts:Media RelationsFor Sobi Media contacts, click here. Investor RelationsFor details on how to contact the Sobi Investor Relations Team, click here. Sanofi Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words expects, anticipates, believes, intends, estimates, plans and similar expressions. Although Sanofis management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofis ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. Any material effect of COVID-19 on any of the foregoing could also adversely impact us. This situation is changing rapidly and additional impacts may arise of which we are not currently aware and may exacerbate other previously identified risks. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under Risk Factors and Cautionary Statement Regarding Forward-Looking Statements in Sanofis annual report on Form 20-F for the year ended December 31, 2021. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. i Physical health was assessed with the Haem-A-QoL Physical Health score. Pain intensity was assessed using the PROMIS Pain Intensity 3a past 7 days intensity of pain at its worst score. Joint health was assessed using the Hemophilia Joint Health score. Attachment Source: West Corporation Jul 10, 2022: Banco Santander Press Release: Fitusiran prophylaxis reduced bleeds by 61% in people with hemophilia A or B, with or without inhibitors, compared to prior factor or bypassing agent prophylaxis Fitusiran prophylaxis reduced bleeds by 61% in people with hemophilia A or B, with or without inhibitors, compared to prior factor or bypassing agent prophylaxis A median annualized bleeding rate (ABR) of 0.0 was reported in the overall study population during fitusiran prophylaxis (80 mg monthly)Fitusiran is a novel, investigational subcutaneously administered small interference RNA therapy, in development for the prophylactic treatment of people with hemophilia A or B, with or without inhibitor Paris July 10, 2022 Positive data from the Phase 3 ATLAS-PPX study evaluating the efficacy and safety of once-monthly fitusiran (80 mg) in adults and adolescents with severe hemophilia A or B who were previously treated with prior factor or bypassing agent (BPA) prophylaxis were presented today in a late-breaking session at the International Society on Thrombosis and Haemostasis (ISTH) 2022 Congress. The study met the primary endpoint and demonstrated fitusiran prophylaxis significantly reduced bleeding episodes compared to prior factor or BPA prophylaxis. Gili Kenet, MDInvestigator, professor of Hematology, Director of the Israeli National Hemophilia Center at Sheba Medical Center and head of the Amalia Biron Thrombosis Research Institute of Tel Aviv University, Tel Aviv, Israel There is a continued need for transformative therapies that offer people with hemophilia consistent protection while also reducing treatment burden. These phase 3 results are encouraging and support fitusirans potential to provide people with hemophilia A or B, regardless of inhibitor status, with a meaningful reduction in bleeding episodes. Key findings in the Phase 3 ATLAS-PPX study include the following: Dietmar Berger MD, PhDGlobal Head of Development and Chief Medical Officer These positive data support fitusirans potential to transform prophylaxis treatment for people with hemophilia A or B, with or without inhibitors, with a median annual bleed rate of zero across all patient populations. Moreover, we are excited to continue to explore fitusiran under an amended protocol that focuses on dose optimization, including lower doses and less frequent dosing regimens, with the potential for as few as six injections per year. Additional data from the fitusiran clinical program will be shared at the congress including: Consumption of On-demand Factor Concentrates and Bypassing Agents for Management of Breakthrough Bleeds with Fitusiran Prophylaxis in People with Haemophilia A or B: An Analysis of Two Phase 3 Studies. Oral presentation: OC40.3. July 11, 2:45 pm 4:00 pm CET.Fitusiran, an Investigational siRNA Therapeutic Targeting Antithrombin: Analysis of Antithrombin Levels and Thrombin Generation from a Phase 3 Study in People with Haemophilia A or B Without inhibitors. Oral presentation: OC.50.2. July 12, 10:45 am 12:00 pmFitusiran, an Investigational siRNA Therapeutic Targeting Antithrombin: Analysis of Antithrombin Levels and Thrombin Generation from a Phase 3 Study in People with Haemophilia A or B With inhibitors. Poster presentation: PB1152. July 12, 6:30 pm -7:30 pm CET) Collectively, these data add to a growing body of evidence, including results from the ATLAS A/B and ATLAS-INH Phase 3 studies, supporting fitusirans potential to transform treatment for all people with hemophilia. Hemophilia A and B are rare congenital bleeding disorders caused by a deficiency of factor VIII and IX, respectively, resulting in insufficient thrombin generation and ineffective clot formation further complicated in patients who develop inhibitors to their factor treatment. Sanofi is currently investigating the efficacy and safety of fitusiran under an amended protocol which includes lower doses and a less frequent dosing regimen maintaining an antithrombin target range of 15-35% in all ongoing studies. Fitusiran has the potential to provide prophylactic treatment for all people with hemophilia A or B, with or without inhibitors, with as few as six subcutaneous injections per year. ATLAS-PPX Phase 3 study design (NCT03549871) ATLAS-PPX is a multinational, open-label, Phase 3 study designed to evaluate the efficacy and safety of fitusiran in adult and adolescents aged 12 years with severe hemophilia A or B, with or without inhibitors, who have switched from prior factor or bypassing agent prophylaxis. A total of 80 participants were enrolled. In the study, participants continued their pre-study prophylaxis regimen with factor or bypassing agents for a six-month period followed by a switch to once-monthly fitusiran (80 mg) administered subcutaneously for seven months. The primary endpoint of the study was annualized bleeding rate. About fitusiran Fitusiran is an investigational, subcutaneously administered small interference RNA therapeutic in development for the prophylactic treatment of people with hemophilia A or B, with or without inhibitors. Fitusiran is designed to lower antithrombin, a protein that inhibits blood clotting, with the goal of promoting thrombin generation to rebalance hemostasis and prevent bleeds. Fitusiran utilizes Alnylam Pharmaceutical Inc.s ESC-GalNAc conjugate technology, which enables subcutaneous dosing with increased potency and durability. Fitusiran is currently under clinical investigation and has not been evaluated by any regulatory authority. About Sanofi We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Media RelationsSally Bain|+ 1 617 834 6026 |sally.bain@sanofi.com Investor RelationsEva Schaefer-Jansen|+ 33 7 86 80 56 39 |eva.schaefer-jansen@sanofi.comArnaud Delepine|+ 33 6 73 69 36 93 | arnaud.delepine@sanofi.comCorentine Driancourt|+ 33 6 40 56 92 21 | corentine.driancourt@sanofi.comFelix Lauscher|+ 1908612 7239 | felix.lauscher@sanofi.comPriya Nanduri|+1 617 764 6418 | priya.nanduri@sanofi.com Nathalie Pham|+ 33 7 85 93 30 17 | nathalie.pham@sanofi.com Sanofi Forward-Looking Statements This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words expects, anticipates, believes, intends, estimates, plans and similar expressions. Although Sanofis management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofis ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. Any material effect of COVID-19 on any of the foregoing could also adversely impact us. This situation is changing rapidly and additional impacts may arise of which we are not currently aware and may exacerbate other previously identified risks. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under Risk Factors and Cautionary Statement Regarding Forward-Looking Statements in Sanofis annual report on Form 20-F for the year ended December 31, 2021. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. Attachment Source: West Corporation Jul 04, 2022: Banco Santander Sanofi Global Health launches nonprofit Impact brand for 30 medicines in low-income countries Sanofi Global Health launches nonprofit Impact brand for 30 medicines in low-income countries Medicines, including insulin, to be available in 40 lower-income countriesInvestment fund established to help create sustainable health systems Announcements comes as Global Health stakeholders gather in Paris Paris July 4, 2022 Sanofi Global Health announces the launch of Impact, a new brand of standard of care medicines produced by Sanofi dedicated for nonprofit distribution to at-risk populations in the worlds most impoverished countries. The Impact brand, which includes insulin, glibenclamide and oxaliplatin amonst others, will enable the secure distribution of 30 Sanofi medicines in 40 lower-income countries. Considered essential by the World Health Organization, the medicines cover a wide range of therapeutic areas, including diabetes, cardiovascular disease, tuberculosis, malaria and cancer. The launch of the Impact brand is among the steps taken since the formation last year of Sanofi Global Health, a nonprofit unit within the company aiming to increase access to healthcare through the distribution of medicines, and the building and bolstering of local healthcare systems in countries with among the lowest per capita GDP. Sanofi Global Health is the first and only global initiative to provide access to such a broad portfolio of medicines in so many countries and across multiple therapeutic areas while funding local support programs and strengthening local inclusive businesses. Paul HudsonChief Executive Officer, SanofiAt Sanofi, we believe we have a responsibility to make a difference for the health of those most in need, and we know we have the ability and the ambition to bring about lasting change. With critical medicines, relentless drive and impactful partnerships, we can take our innovation beyond the lab and use it to strengthen health systems and access to medicines for those most vulnerable communities of patients. Sanofi Global Health aims to improve the lives of millions of people who now cannot get the help they need. Sanofis renewed purpose is to chase the miracles of science to improve peoples lives. And our quest to make life better for all people must include helping to provide better access to care and quality medicines for underserved populations. The company also announces the establishment of an Impact fund that will support startup companies and other innovators that can deliver scalable solutions for sustainable healthcare in underserved regions. By providing inclusive businesses financing and technical assistance, the fund will complement the GHU mission of leveraging global, regional and local investment to support the training of healthcare professionals and aiding communities in running sustainable care systems. The announcements come as Sanofi gathers key global health stakeholders to discuss how to build effective end-to-end health programs that are embedded in the communities in which they serve, to best reach, treat and manage patients health effectively and sustainably. Jon FairestHead, Global Health Unit, SanofiThe launch of the Impact brand and our Impact Fund are our latest steps to make our medicines available and to help bring quality, sustainable healthcare to people in the worlds poorest countries. But we know that we cannot do this alone, and so we are building partnerships at global, regional and local levels that will help to improve and establish health systems to reach our goal of a healthier, more resilient world. Sanofi Global Health is one of the three elements of Sanofis multi-tiered approach to Social impact, which includes the Foundation S the Sanofi collective dedicated to philanthropy and a Corporate Social Responsibility strategy embedded in our business activities: Foundation S is focused on efforts to fight childhood cancer, increase the health resilience of populations most affected by climate change, and provide donations of products to meet humanitarian crises. Carrying on the companys 30-year legacy, Sanofi has also committed to donating 100,000 vials every year free of charge to support to patients with five different lysosomal storage disorders (LSDs), a group of rare genetic conditions caused by enzyme deficiencies.Our company-wide CSR strategy focuses on four pillars: affordable access; innovation for vulnerable communities; planet care, in and beyond the workplace; in addition to responsible business. It is built around flagship initiatives spread across the companys value chain, from R&D to manufacturing to commercial operations, considering every part of the organization has a role to play and a contribution to make. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Media RelationsNicolas Obrist|+ 33 6 77 21 27 55 |nicolas.obrist@sanofi.comEvan Berland |+ 1 215 432 0234 |evan.berland@sanofi.com Sanofi Investor RelationsEva Schaefer-Jansen|+ 33 7 86 80 56 39 |eva.schaefer-jansen@sanofi.comArnaud Delepine|+ 33 6 73 69 36 93 | arnaud.delepine@sanofi.comCorentine Driancourt|+ 33 6 40 56 92 21 | corentine.driancourt@sanofi.comFelix Lauscher|+ 1908612 7239 | felix.lauscher@sanofi.comPriya Nanduri|+1 617 764 6418 | priya.nanduri@sanofi.com Nathalie Pham|+ 33 7 85 93 30 17 | nathalie.pham@sanofi.com Sanofi Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements are generally identified by the words "expects", "anticipates", "believes", "intends", "estimates", "plans" and similar expressions. Although Sanofi's management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. Any material effect of COVID-19 on any of the foregoing could also adversely impact us. This situation is changing rapidly and additional impacts may arise of which we are not currently aware and may exacerbate other previously identified risks. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in Sanofi's annual report on Form 20-F for the year ended December 31, 2021. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. Attachment PR Sanofi Global Health Unit 070422 Source: West Corporation Jun 28, 2022: Banco Santander Press Release: Xenpozyme (olipudase alfa) approved by European Commission as first and only treatment for ASMD Xenpozyme (olipudase alfa) approved by European Commission as first and only treatment for ASMD Paris, June 28, 2022. The European Commission (EC) has approved Xenpozyme (olipudase alfa) as the first and only enzyme replacement therapy for the treatment of non-Central Nervous System (CNS) manifestations of Acid Sphingomyelinase Deficiency (ASMD) in pediatric and adult patients with ASMD type A/B or ASMD type B. The approval is based on positive data from the ASCEND and ASCEND-Peds clinical trials, in which Xenpozyme showed substantial and clinically relevant improvement in lung function (as measured by diffusing capacity of the lung for carbon monoxide, or DLco) and reduction of spleen and liver volumes, with a well-tolerated safety profile. Given the urgent unmet medical needs of the ASMD community, the European Medicines Agency (EMA) granted Xenpozyme PRIority MEdicines (PRIME) designation. Xenpozyme has also received special breakthrough designations from several other regulatory agencies around the world. John Reed, M.D., Ph.DExecutive Vice President, Global Head of Research and Development, Sanofi The ASMD community has waited many years for a treatment for this rare and debilitating genetic disease. The approval of Xenpozyme by the European Commission represents a transformational shift in what we can offer to patients, demonstrated by the clinically important improvements across major manifestations of ASMD and the sustained effects noted over longer term treatment. ASMD is an extremely rare, progressive genetic disease with significant morbidity and mortality, especially among infants and children, as many pediatric patients will not survive to adulthood. Signs and symptoms of ASMD may include enlarged spleen or liver, difficulty breathing, lung infections, and unusual bruising or bleeding, among other disease manifestations. Current management of the disease includes palliative and supportive care to manage the symptoms. Xenpozyme is an enzyme replacement therapy designed to replace deficient or defective acid sphingomyelinase (ASM), an enzyme that allows for the breakdown of the lipid sphingomyelin. In individuals with ASMD, the insufficient amount of the ASM enzyme means sphingomyelin is poorly metabolized, potentially leading to lifelong accumulation inand damage to multiple organs. Maurizio Scarpa, M.D., Ph.DUniversity Hospital of Udine, ItalyWe welcome the European Union approval of Xenpozyme as the first and only disease-specific therapy for ASMD with a potential to oppose disease progression. This is a significant milestone for individuals living with ASMD, a disease associated with substantial morbidity and risk of premature death.Approval based on positive results from two clinical trials in children and adults ASCEND The ASCEND trial randomized 36 adult patients with ASMD type A/B or type B to receive Xenpozyme or placebo for 52 weeks (primary analysis), to evaluate the efficacy and safety of the drug. The study demonstrated that Xenpozyme improved lung function, assessed as the percent change from baseline to week 52 in predicted diffusing capacity of the lung for carbon monoxide (DLco), and reduced spleen size, evaluated as percent change from baseline in multiples of normal (MN) spleen volume. Patients treated with Xenpozyme had improvement in DLco from baseline to week 52 of 22% compared to 3% for the patients in the placebo group. The difference between the two treatment arms (19%) was statistically significant (p=0.0004).Patients treated with Xenpozyme had reduction in spleen size by 39.5% at week 52 compared to increase by 0.5% for the patients in the placebo group. The difference between the two treatment arms (40%) was statistically significant (p<0.0001).All ASCEND patients treated with Xenpozyme showed improvement in one or both primary endpoints (DLco and spleen size reduction). The incidence of adverse events (AEs) was similar in patients receiving Xenpozyme to that in patients receiving placebo. There were five serious AEs in the Xenpozyme arm and 11 in the placebo arm, none of which was treatment-related. There were no AEs that led to treatment discontinuation or study withdrawal. The most common AEs in the ASCEND trial were headache, nasopharyngitis, upper respiratory tract infection, cough, and arthralgia. ASCEND-Peds The single-arm ASCEND-Peds trial studied 20 pediatric patients with ASMD type A/B or type B who all received Xenpozyme, with a primary objective of evaluating the safety and tolerability of Xenpozyme for 64 weeks. All patients completed the study and continued in an extension trial. The ASCEND-Peds study also explored efficacy endpoints of progressive lung disease and of spleen and liver enlargement. After one year of treatment (52 weeks), the percent predicted DLco mean increase from baseline was 33% in nine patients who were able to perform the test at baseline (children over the age of five were assessed if they were able to perform the test). Additionally, the spleen volume mean decrease was 49% compared to baseline. Over the 64-week treatment period, all ASCEND-Peds patients experienced at least one AE, which were mostly mild and moderate. Five treatment-related serious AEs were observed in three patients: two cases of transient, asymptomatic alanine aminotransferase (ALT) increase in one patient, one case each of urticaria and rash in one patient, and one anaphylactic reaction in one patient. No patients had to permanently discontinue treatment due to an AE. The most common AEs in the ASCEND-Peds trial were pyrexia, cough, vomiting, nasopharyngitis, diarrhea, headache, upper respiratory tract infection, contusion, abdominal pain, nasal congestion, rash, urticaria, scratch, and epistaxis. About Xenpozyme Xenpozyme (olipudase alfa) is an enzyme replacement therapy designed to replace deficient or defective acid sphingomyelinase (ASM), an enzyme that allows for the breakdown of sphingomyelin. Accumulation of sphingomyelin in cells can cause harm to the lungs, spleen, and liver, as well as other organs, potentially leading to early death. Xenpozyme has been evaluated in pediatric and adult patients to treat non-CNS manifestations of ASMD type A/B and ASMD type B. Xenpozyme has not been studied in patients with ASMD type A. In March 2022, Xenpozyme was approved in Japan under the SAKIGAKE (or pioneer) designation, marking the first approval for olipudase alfa anywhere in the world. In the United States, where olipudase alfa received Breakthrough Therapy designation, the Food and Drug Administration (FDA) is currently reviewing olipudase alfas Biologics License Application (BLA), with a target action date for the FDA decision (PDUFA date) anticipated for October 2022. About ASMD Historically known as Niemann-Pick disease types A, A/B, and B, ASMD is a rare, progressive, and potentially life-threatening genetic disease. ASMD represents a spectrum of disease, with two types that may represent opposite ends of a continuum referred to as ASMD type A and ASMD type B. ASMD type A/B is an intermediate form that includes varying degrees of central nervous system (CNS) involvement. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions.Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Media RelationsSandrine Guendoul|+ 33 6 25 09 14 25 |sandrine.guendoul@sanofi.comSally Bain|+ 1 617 834 6026 |sally.bain@sanofi.comKate Conway|+ 1508364 4931 |kate.conway@sanofi.com Investor RelationsEva Schaefer-Jansen|+ 33 7 86 80 56 39 |eva.schaefer-jansen@sanofi.comArnaud Delepine|+ 33 6 73 69 36 93 | arnaud.delepine@sanofi.comCorentine Driancourt|+ 33 6 40 56 92 21 | corentine.driancourt@sanofi.comFelix Lauscher|+ 1908612 7239 | felix.lauscher@sanofi.comPriya Nanduri|+1 617 764 6418| priya.nanduri@sanofi.com Nathalie Pham|+ 33 7 85 93 30 17 | nathalie.pham@sanofi.com Sanofi Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements are generally identified by the words "expects", "anticipates", "believes", "intends", "estimates", "plans" and similar expressions. Although Sanofi's management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. Any material effect of COVID-19 on any of the foregoing could also adversely impact us. This situation is changing rapidly and additional impacts may arise of which we are not currently aware and may exacerbate other previously identified risks. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in Sanofi's annual report on Form 20-F for the year ended December 31, 2021. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. Attachment Source: West Corporation Jun 28, 2022: Banco Santander Press Release: Nexviadyme (avalglucosidase alfa) approved by European Commission as a potential new standard of care for the treatment of Pompe Disease Nexviadyme (avalglucosidase alfa) approved by European Commission as a potential new standard of care for the treatment of Pompe Disease Approved for the treatment of the full spectrum of both late-onset Pompe disease and infantile-onset Pompe diseaseFirst new treatment option approved for the Pompe community in Europe in more than 15 years Paris, June 28, 2022 The European Commission has granted marketing authorization for Nexviadyme (avalglucosidase alfa), an enzyme replacement therapy (ERT) for the long-term treatment of both late-onset and infantile-onset Pompe disease, a rare, progressive and debilitating muscle disorder. Nexviadyme is the first and only newly approved medicine for Pompe disease in Europe since 2006, when the European Commission authorized the marketing of alglucosidase alfa, branded Myozyme. Benedikt Schoser, MD.Senior Consultant and Professor, Friedrich-Baur-Institute, Department of Neurology, Ludwig-Maximilians-University MunichThe approval of Nexviadyme in Europe to treat Pompe disease is backed by a robust body of evidence showing clinically meaningful improvements that can impact quality of life. The totality and rigor of the data is particularly noteworthy given the complexities of research and development for such a rare and progressive condition. Nexviadymes demonstrated clinical benefit and molecular innovation bring a new treatment option to people living with Pompe disease who continue to face unmet needs. Addressing an unmet need for people living with Pompe disease Pompe disease can present as infantile-onset Pompe disease (IOPD), the most severe form of the disease with rapid onset in infancy, or late-onset Pompe disease (LOPD), which progressively damages muscles over time. If left untreated, IOPD can lead to heart failure and death within the first year of life, while people with LOPD may require mechanical ventilation to help with breathing or a wheelchair to assist with mobility as the disease progresses. Nexviadyme now approved in many countries around the world Nexviadyme is approved in multiple markets around the world for the treatment of certain people living with Pompe disease, including the European Union, the United States, Japan, Canada, Switzerland, Australia, Brazil, Taiwan and the United Arab Emirates. Outside of Europe, the treatment is marketed under the brand name Nexviazyme. In the U.S. and Japan, the majority of the Myozyme (alglucosidase alfa)-treated population has started, or is in the process of starting, treatment with Nexviazyme (avalglucosidase alfa). In November 2021, Sanofi announced that as part of the European Medicines Agencys (EMA) review of Nexviadyme, the Committee for Medicinal Products for Human Use (CHMP) issued an opinion that the therapy does not qualify as a New Active Substance (NAS). In April 2022, the Committee for Orphan Medicinal Product (COMP) also recommended Nexviadyme be removed from the Community Register of Orphan Medicinal Products (OMP). Sanofi strongly disagrees with both opinions and believes these conclusions were the result of an erroneous and very narrow interpretation of the NAS and OMP principles that demonstrate molecular innovation and clinical benefit. Sanofi stands by the totality of data in support of Nexviadyme as a potential new standard of care and is concerned that such narrow interpretation will undermine rare disease incentive mechanisms in Europe. We believe withholding these distinct designations could negatively impact patient health in Europe by restricting access to innovative advancements in care. Bill SiboldExecutive Vice President, Specialty Care, SanofiFor more than two decades, weve been working with the community and leveraging our scientific expertise to improve care for people living with Pompe disease. We strongly believe in the meaningful clinical benefits of this medicine as a new standard of care and will work hard to ensure the broadest possible access in Europe despite the European Commissions failure to recognize Nexviadymes NAS and OMP designations. We call on patient advocacy groups, policymakers, clinicians and patients to join us in our efforts to ensure innovative treatments are appropriately recognized and made available to patients in Europe and beyond. Nexviadyme, a new ERT for late-onset Pompe disease and infantile-onset Pompe Disease Positive outcomes in key disease burden measures In a robust clinical development program, Nexviadyme demonstrated clinically meaningful differences in key areas of disease burden for people living with late-onset Pompe disease and infantile-onset Pompe disease. Results from the COMET study comparing Nexviadyme to alglucosidase alfa in LOPD at 49 weeks included: Patients treated with Nexviadyme showed a 2.9% improvement from baseline (SE=0.9) in forced vital capacity (FVC) percent-predicted, a key measure of respiratory function and the studys primary endpoint, which was 2.4% points greater as compared to the change with alglucosidase alfa. This difference exceeded the non-inferiority margin (p=0.0074; 95% CI, -0.13, 4.99). Statistical superiority was narrowly missed (p=0.06). Patients treated with Nexviadyme walked 32.2 meters farther (SE=9.9) compared to baseline in the 6-minute walk test (6MWT), a key secondary endpoint, which was 30 meters farther (p=0.040; 95% CI, 1.33, 58.69) than the change with alglucosidase alfa. Formal statistical testing for all secondary endpoints was not conducted. Results from the Mini-COMET study evaluating Nexviadyme in IOPD patients showed improvement or stabilization at six months in efficacy outcomes, the trials secondary objective, of gross motor function measure (GMFM-88), quick motor function test (QMFT), pediatric evaluation of disability index (Pompe-PEDI), left ventricular mass z-score (LVMZ), and eyelid position measurements in patients previously declining or insufficiently controlled with alglucosidase alfa. A pooled safety analysis from four clinical studies found serious adverse reactions reported in patients treated with Nexviadyme included chills (1.4%), headache, dyspnoea, respiratory distress, nausea, skin discoloration, chest discomfort, pyrexia, blood pressure increased, body temperature increased, heart rate increased, and oxygen saturation decreased (0.7% each). Additionally, hypersensitivity reactions (43.5%), anaphylaxis (1.4%) and infusion-associated reactions (26.1%) were reported. The most frequently reported adverse drug reactions (ADRs) (>5%) were pruritus (9.4%), rash (8%), headache (7.2%), urticaria (6.5%), fatigue (6.5%), nausea (5.8%), and chills (5.1%). Mechanism of action designed for increased uptake People living with Pompe disease have low levels of the enzyme acid alpha-glucosidase (GAA), which results in build-up of glycogen, leading to irreversible damage to skeletal and cardiac muscles. Nexviadyme is specifically designed to target the mannose-6-phosphate (M6P) receptor, the key pathway for cellular uptake of ERT and transport to the lysosome, and has an average 15-fold higher level of M6P moieties as compared to alglucosidase alfa. Nexviadyme aims to help improve uptake and enhance glycogen clearance in target tissues as compared to alglucosidase alfa, which was used as the comparator arm in the pivotal Phase 3 COMET study. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Media RelationsSandrine Guendoul|+ 33 6 25 09 14 25 |sandrine.guendoul@sanofi.comSally Bain|+ 1 617 834 6026 |sally.bain@sanofi.comKate Conway|+ 1508364 4931 |kate.conway@sanofi.com Investor RelationsEva Schaefer-Jansen | + 33 7 86 80 56 39 | eva.schaefer-jansen@sanofi.comArnaud Delepine | + 33 06 73 69 36 93 | arnaud.delepine@sanofi.comCorentine Driancourt | + 33 06 40 56 92 | corentine.driancourt@sanofi.comFelix Lauscher | + 1 908 612 7239 | felix.lauscher@sanofi.comPriya Nanduri |+1 617 764 6418 | priya.nanduri@sanofi.comNathalie Pham | + 33 07 85 93 30 17 | nathalie.pham@sanofi.com Sanofi Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements are generally identified by the words expects, anticipates, believes, intends, estimates, plans and similar expressions. Although Sanofis management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. Any material effect of COVID-19 on any of the foregoing could also adversely impact us. This situation is changing rapidly and additional impacts may arise of which we are not currently aware and may exacerbate other previously identified risks. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under Risk Factors and Cautionary Statement Regarding Forward-Looking Statements in Sanofis annual report on Form 20-F for the year ended December 31, 2021. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. Attachment Source: West Corporation Jun 24, 2022: Banco Santander Press Release: Sanofi-GSK first to report a successful efficacy study against Omicron with COVID-19 Beta-containing vaccine Sanofi-GSK first to report a successful efficacy study against Omicron with COVID-19 Beta-containing vaccine Primary vaccination with Beta-containing vaccine candidate delivers 64.7% efficacy against symptomatic infection in adults, and 75.1% efficacy in participants previously infected with COVID-19 Against Omicron, sequencing analysis performed to date shows 72% efficacy in all adults and 93.2% in seropositivesFavorable safety and tolerability profile First ever reported efficacy data in an Omicron environment support relevance of a Beta-containing vaccine Paris, June 24, 2022. Sanofi and GSK today announce positive data from their vaccine trial which evaluated an adjuvanted bivalent D614 and Beta (B.1.351) vaccine candidate. Sanofi-GSKs vaccine is the first candidate to demonstrate efficacy in a placebo-controlled trial in an environment of high Omicron variant circulation. The vaccine candidate showed a favorable safety and tolerability profile. Earlier this month Sanofi reported positive data from two trials conducted with its new next-generation COVID-19 booster vaccine candidate modelled on the Beta variant antigen and including GSKs pandemic adjuvant. The data supporting this next-generation booster vaccine will be submitted to regulatory authorities and indicate the potential of Sanofi-GSKs next-generation Beta-based booster to be a relevant response to public health needs. Thomas TriompheExecutive Vice President Vaccines, SanofiTodays results reinforce the strong potential for the Beta antigen to confer broad protection against multiple strains that cause COVID-19. With the immunogenicity data from our Beta-booster vaccine, they support our belief that, in a largely seropositive world, a next-generation Beta booster vaccine could provide protection against variants like Omicron. mRNA has proven speed to market; we are demonstrating here the efficacy that our recombinant protein platform can provide to the world. We look forward to completing our submissions to regulatory authorities and are ready to contribute to ongoing vaccination campaigns with our next-generation booster. Roger ConnorPresident of GSK VaccinesThese positive data show efficacy of our protein-based, bivalent adjuvanted vaccine candidate in an environment of high Omicron variant circulation. Our vaccine candidate has the potential to make an important contribution to public health as the pandemic evolves further. We are looking forward to the discussions with regulatory authorities with the aim of making our vaccine candidate available later this year. In Stage 2 of the Phase 3 COVID-19 vaccine trial VAT08 of more than 13,000 participants 18 and above years of age, the Sanofi-GSK Beta-containing vaccine candidate demonstrated an efficacy of 64.7% (95% confidence interval [CI, 46.6, 77.2]) against symptomatic COVID-19 and 72% efficacy (95% confidence interval [CI, 45.8, 86.6]) in Omicron-confirmed symptomatic cases (sequencing was performed for 71 cases out of 121 total cases to date). In previously seropositive populations, the Sanofi-GSK vaccine candidate demonstrates an overall efficacy of 75.1% (95% confidence interval [CI, 56.3, 86.6]) against symptomatic infection, and 93.2% (95% confidence interval [CI, 73.2, 99.2]) in Omicron-confirmed symptomatic cases, according to the sequencing analysis performed to date. Throughout Stage 1 and Stage 2 of the VAT08 trial (~23,000 participants in total), the Sanofi-GSK vaccine demonstrated a favorable safety and tolerability profile.These efforts are supported by federal funds from the Biomedical Advanced Research and Development Authority, part of the office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services in collaboration with the U.S. Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense under Contract # W15QKN-16-9-1002 and the National Institute of Allergy and Infectious Diseases (NIAID). About the Sanofi and GSK partnershipIn the collaboration between the two companies, Sanofi provides its recombinant antigen and will be the marketing authorization holder. GSK contributes with its pandemic adjuvant, both established vaccine platforms that have proven successful against influenza. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Media RelationsSandrine Guendoul|+ 33 6 25 09 14 25 |sandrine.guendoul@sanofi.comSally Bain|+ 1 617 834 6026 |sally.bain@sanofi.comEvan Berland | +1 215 432 0234 | evan.berland@sanofi.comNicolas Obrist|+ 33 6 77 21 27 55 |nicolas.obrist@sanofi.com Investor RelationsEva Schaefer-Jansen|+ 33 7 86 80 56 39 |eva.schaefer-jansen@sanofi.comArnaud Delepine|+ 33 6 73 69 36 93 | arnaud.delepine@sanofi.comCorentine Driancourt|+ 33 6 40 56 92 21 | corentine.driancourt@sanofi.comFelix Lauscher|+ 1908612 7239 | felix.lauscher@sanofi.comPriya Nanduri| +1 617 764 6418 |priya.nanduri@sanofi.com Nathalie Pham|+ 33 7 85 93 30 17 | nathalie.pham@sanofi.com Sanofi Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words expects, anticipates, believes, intends, estimates, plans and similar expressions. Although Sanofis management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofis ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. Any material effect of COVID-19 on any of the foregoing could also adversely impact us. This situation is changing rapidly and additional impacts may arise of which we are not currently aware and may exacerbate other previously identified risks. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under Risk Factors and Cautionary Statement Regarding Forward-Looking Statements in Sanofis annual report on Form 20-F for the year ended December 31, 2021. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. Attachment Press_Release Source: West Corporation Jun 24, 2022: Banco Santander Availability of the Q2 2022 Memorandum for modelling purposes Availability of the Q2 2022 Memorandum for modelling purposes Paris, France June 24, 2022 - Sanofi announced today that its Q2 2022 Memorandum for modelling purposes is available on the "Investors" page of the company's website: https://www.sanofi.com/en/investors/financial-results-and-events/financial-results/Q2-results-2022 As for each quarter, Sanofi prepared this document to assist in the financial modelling of the Group's quarterly results. This document includes a reminder on various non-comparable items and exclusivity losses as well as the foreign currency impact and share count. Sanofi's second-quarter 2022 results will be published on July 28, 2022. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Media RelationsSandrine Guendoul | + 33 6 25 09 14 25 | sandrine.guendoul@sanofi.comSally Bain | + 1 617 834 6026 | sally.bain@sanofi.comNicolas Obrist | + 33 06 77 21 27 55 | nicolas.obrist@sanofi.comVictor Rouault | + 33 06 70 93 71 40 | victor.rouault@sanofi.com Investor RelationsEva Schaefer-Jansen | + 33 7 86 80 56 39 | eva.schaefer-jansen@sanofi.com Arnaud Delepine | + 33 06 73 69 36 93 | arnaud.delepine@sanofi.comCorentine Driancourt | + 33 06 40 56 92 | corentine.driancourt@sanofi.com Felix Lauscher | + 1 908 612 7239 | felix.lauscher@sanofi.com Priya Nanduri | +1617764 6418 | priya.nanduri@sanofi.com Nathalie Pham | + 33 07 85 93 30 17 | nathalie.pham@sanofi.com Sanofi Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words expects, anticipates, believes, intends, estimates, plans and similar expressions. Although Sanofis management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofis ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. Any material effect of COVID-19 on any of the foregoing could also adversely impact us. This situation is changing rapidly and additional impacts may arise of which we are not currently aware and may exacerbate other previously identified risks. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under Risk Factors and Cautionary Statement Regarding Forward-Looking Statements in Sanofis annual report on Form 20-F for the year ended December 31, 2021. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. Attachment PR.Q2 2022.Memorandum.eng Source: West Corporation Jun 13, 2022: Banco Santander Press Release: Sanofi-GSK next-generation COVID-19 booster delivers strong immune response against variants of concern, including Omicron Sanofi-GSK next-generation COVID-19 booster delivers strong immune response against variants of concern, including Omicron Next-generation booster vaccine candidate delivers immune boost in adults primed with mRNA vaccines; with a stronger immune response compared to Pfizer-BioNTechs Comirnaty booster vaccineNext-generation booster vaccine candidate demonstrates potential to protect against COVID-19 variants of concern, including Omicron BA.1 and BA.2, with a favorable safety and tolerability profile Paris June 13, 2022 Sanofi today reports data from two trials, VAT02 Cohort 2 and COVIBOOST VAT013, conducted with its new next-generation COVID-19 booster vaccine candidate modelled on the Beta variant antigen and including GSKs pandemic adjuvant. In the Phase 3 VAT02 Cohort 2 study, the Sanofi-GSK next-generation vaccine candidate induced (at day 15 post-immunization) a significant boost in antibody titers above baseline against multiple variants of concern (15-fold increase against D614 parent virus, 30-fold increase against Beta strain) in adults previously primed with mRNA COVID-19 vaccines. In particular against Omicron, preliminary data show a 40-fold increase against BA.1. The Sanofi-GSK next-generation booster candidate generated double the number of neutralizing antibodies against Omicron BA.1 and BA.2 compared to the D614-based (original parent virus) booster. In parallel, the independent COVIBOOST (VAT013) study conducted by the Assistance Publique Hopitaux de Paris (AP-HP) demonstrated that, following primary vaccination with two doses of Pfizer-BioNTechs Comirnaty vaccine, the Sanofi-GSK next-generation booster candidate generated a higher immune response (as measured by neutralizing antibody titers) than Pfizer-BioNTechs booster or the Sanofi-GSK first-generation booster, both of which target the original D614 parent strain. The proportion of participants with at least a 10-fold increase in neutralizing antibody titers for the original D614 SARS-CoV-2 strain between day 0 and day 15 was: 76.1% (95% CI 64.585.4) for the Sanofi-GSK next-generation booster, vs63.2% (95% CI 51.373.9) for the Pfizer BioNTech D614 booster, and 55.3% (95% CI 43.466.7) for the Sanofi-GSK D614 (first-generation parent booster candidate). In this study, which included 247 subjects, all the three vaccines also elicited neutralizing antibodies against the Omicron BA.1 variant, with highest responses generated by the Sanofi-GSK next-generation candidate. Results of COVIBOOST study are available on a pre-print server, pending publication in a peer-reviewed journal. Across both studies, the Sanofi-GSK next-generation vaccine candidate was well-tolerated, with a favorable safety profile. In the VAT02 cohort 2 study, low numbers (less than 4%) of Grade 3 reactions were reported, all transient and non-severe. Thomas Triomphe Executive Vice President, Sanofi Vaccines COVID-19 keeps evolving and the combination of emergence of variants and waning immunity is likely to lead to the need for additional booster shots, at least in some populations.The Beta variant expresses similar mutations across multiple variants of concern, including Omicron, making it a strong vaccine candidate to confer broad protection against multiple strains of COVID-19. Seeing the cross-neutralization data from the independent AP-HP study, we believe this next-generation booster could have an important role to play for public health vaccination campaigns. We look forward to submitting these data to global regulatory authorities. Sanofi and GSK have developed their next-generation booster candidate in parallel to ongoing regulatory reviews of their first-generation vaccine candidate. The totality of data supporting this next-generation booster vaccine will be submitted to regulatory authorities in the upcoming weeks, with the aim of making it available later this year. About VAT02The VAT02 booster study is an extension of the companys phase 3 safety and immunogenicity study. In Cohort 1 of this study, participants previously vaccinated with the primary series of an authorized COVID-19 vaccine received a booster dose of the Sanofi-GSK adjuvanted recombinant vaccine candidate, using SARS-CoV-2 (D614) antigen. These data confirmed the vaccine candidates universal potential to boost neutralizing antibodies 18- to 30-fold across all vaccine platforms (mRNA, protein, adenovirus). Cohort 2 included 1,500 participants. VAT02 results will be published in a peer-reviewed journal at a later date. These efforts are supported by federal funds from the Biomedical Advanced Research and Development Authority, part of the office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services in collaboration with the U.S. Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense under Contract # W15QKN-16-9-1002 and by the National Institute of Allergy and Infectious Diseases (NIAID). The NIAID provides grant funding to the HIV Vaccine Trials Network (HVTN) Leadership and Operations Center (UM1 AI 68614HVTN), the Statistics and Data Management Center (UM1 AI 68635), the HVTN Laboratory Center (UM1 AI 68618), the HIV Prevention Trials Network Leadership and Operations Center (UM1 AI 68619), the AIDS Clinical Trials Group Leadership and Operations Center (UM1 AI 68636), and the Infectious Diseases Clinical Research Consortium (UM1 AI 148684, UM1 AI 148450, UM1 AI 148372 , UM1 AI 148574). About COVIBOOST (VAT013) studyCOVIBOOST is an independent study conducted by the Assistance Publique Hopitaux de Paris (AP-HP). It is a randomized, single-blinded, multicenter trial across 11 centers in France, which studies the immune response of the Sanofi-GSK first- and next-generation booster vaccine candidates (adjuvanted, recombinant protein) and that of a 3rd dose of the Pfizer-BioNTech vaccine Comirnaty, following two doses of Comirnaty received as primary vaccination. The study was funded by the French Ministry of Solidarity and Health and Sanofi. About the Sanofi and GSK partnership In the collaboration between the two companies, Sanofi provides its recombinant antigen and GSK contributes its pandemic adjuvant, both established vaccine platforms that have proven successful against influenza. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Media RelationsSandrine Guendoul|+ 33 6 25 09 14 25 |sandrine.guendoul@sanofi.comSally Bain|+ 1 617 834 6026 |sally.bain@sanofi.comNicolas Obrist|+ 33 6 77 21 27 55 |nicolas.obrist@sanofi.comEvan Berland |+ 1 215 432 0234 |evan.berland@sanofi.com Investor RelationsEva Schaefer-Jansen|+ 33 7 86 80 56 39 |eva.schaefer-jansen@sanofi.comArnaud Delepine|+ 33 6 73 69 36 93 | arnaud.delepine@sanofi.comCorentine Driancourt|+ 33 6 40 56 92 21 | corentine.driancourt@sanofi.comFelix Lauscher|+ 1908612 7239 | felix.lauscher@sanofi.comPriya Nanduri|+ 1 617 764 6418 | priya.nanduri@sanofi.com Nathalie Pham|+ 33 7 85 93 30 17 | nathalie.pham@sanofi.com Sanofi Forward-Looking Statements This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words expects, anticipates, believes, intends, estimates, plans and similar expressions. Although Sanofis management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofis ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. Any material effect of COVID-19 on any of the foregoing could also adversely impact us. This situation is changing rapidly and additional impacts may arise of which we are not currently aware and may exacerbate other previously identified risks. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under Risk Factors and Cautionary Statement Regarding Forward-Looking Statements in Sanofis annual report on Form 20-F for the year ended December 31, 2021. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. Attachment Source: West Corporation Jun 08, 2022: Banco Santander Sanofi launches its first Digital Accelerator fueled by new talent and focused on growth Sanofi launches its first Digital Accelerator fueled by new talent and focused on growth Paris, June 8, 2022. Sanofi announces the launch of its first Digital Accelerator to foster its ambition to become a leading digital healthcare company. The Accelerator will develop products and solutions that will support Sanofis mission to transform the practice of medicine with the use of digital, data and artificial intelligence (AI). Based in Paris, it already brings together a team of over 75 experts from around the world and will continue to recruit top talent in digital product management, full stack development, and data science. The Digital Accelerator is committed to diversity with internal transfers, external hires, the launch of the Accelerator Academy to upskill the internal workforce and by partnering with the international non-profit organization Women In Tech to close the gender gap in the digital field. The Digital Accelerator will reach 300 people in the next two years at locations that will best support its global digital strategy, attract new talent and further integrate agile ways of working into the companys culture. The Digital Accelerator is first focusing on addressing unmet needs in patients suffering from atopic dermatitis in France, Italy and Spain. The team is developing an integrated platform and data solution to better engage with healthcare professionals (HCPs) and enhance their awareness as well as their patients awareness of the disease and the available treatment options. Arnaud RobertExecutive Vice President & Chief Digital Officer, SanofiSanofis digital transformation is driven by a business and cultural shift as much as it is by technology. The Digital Accelerator will help us democratize the use of data, develop an agile mindset across the company, and accelerate innovation for patients and healthcare professionals at speed and scale. Our investment in the Digital Accelerator is another demonstration of our commitment to transform the practice of medicine and deliver better outcomes for patients. Since sharing its new global digital strategy in 2021, Sanofi has focused on simultaneously building digital and data foundations, delivering business value, developing modern skills, and fostering a digitally-driven and data-driven company culture with the upskilling of over 16,000 employees. More than 300 new talents have joined Sanofi in the last 18 months in France, Spain, the US and Canada to strengthen the companys digital, data and cybersecurity teams. The ongoing digital transformation has already led to significant achievements including: Accelerating the discovery of new targets using AI;Accelerating R&D image analysis using AI, improving from weeks to minutes; Improving clinical trial efficiency by using real-world evidence to reduce the number of patients that must be enrolled and by enabling participants to provide their data and digital biomarkers remotely;Accelerating the access to clinical reports for regulators by using cloud-based data collection and natural language processing; Increasing engagement with HCPs using a global, integrated CRM and Omnichannel solution already deployed in 18 countries;Optimizing Advertising & Promotional spend across multiple markets and products using data integration and AI;Digitizing our manufacturing processes with modern solutions and improving supply chain performance by using predictive AI. By 2025, Sanofis leading digital healthcare platform will support new digital businesses, fuel new digital experiences for patients and HCPs, and drive innovation and efficiencies across the entire value chain from research and development to manufacturing and commercial operations. The deep integration of digital, data and technology solutions is proving critical to transform the practice of medicine and deliver better outcomes for patients. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Media RelationsNicolas Obrist|+ 33 6 77 21 27 55 |nicolas.obrist@sanofi.comKate Conway|+ 1508 364 4931 |kate.conway@sanofi.comVictor Rouault|+ 33 6 70 93 71 40 |victor.rouault@sanofi.com Investor RelationsEva Schaefer-Jansen|+ 33 7 86 80 56 39 |eva.schaefer-jansen@sanofi.comArnaud Delepine|+ 33 6 73 69 36 93 | arnaud.delepine@sanofi.comCorentine Driancourt|+ 33 6 40 56 92 21 | corentine.driancourt@sanofi.com Felix Lauscher|+ 1908612 7239 | felix.lauscher@sanofi.comPriya Nanduri| +1 617 764 6418 |priya.nanduri@sanofi.com Nathalie Pham|+ 33 7 85 93 30 17 | nathalie.pham@sanofi.com Attachment 220608 GPR Sanofi Digital Accelerator ENG Source: West Corporation Jun 07, 2022: Banco Santander Press Release: FDA approves Dupixent (dupilumab) as first biologic medicine for children aged 6 months to 5 years with moderate-to-severe atopic dermatitis FDA approves Dupixent (dupilumab) as first biologic medicine for children aged 6 months to 5 years with moderate-to-severe atopic dermatitis Dupixent is the first and only biologic medicine approved to treat moderate-to-severe atopic dermatitis from infancy to adulthoodChildren treated with Dupixent and topical corticosteroids (TCS) achieved clearer skin, and significantly reduced itch compared to TCS alone at week 16 in a Phase 3 trialLong-term safety data from a 52-week open-label extension trial in this age group reinforce the well-established safety profile of Dupixent observed across all other approved age groups Paris and Tarrytown, N.Y. June 7, 2022. The U.S. Food and Drug Administration (FDA) has approved Dupixent (dupilumab) for children aged 6 months to 5 years with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. A regulatory filing for this age group is under review by the European Medicines Agency and submissions to regulatory authorities in additional countries are underway. Julie BlockPresident and Chief Executive Officer, National Eczema AssociationModerate-to-severe atopic dermatitis in babies and young children is more than just a rash the intense itch can make them scratch uncontrollably throughout the day and night and cause their skin to crack and bleed. Caregivers do their best to manage skincare routines multiple times a day, but for many, topical treatments are not enough. Were pleased to see how scientific innovation and research continues to address unmet needs for the atopic dermatitis community, and were hopeful for the positive impact Dupixent can have for these children and their families. Atopic dermatitis is a chronic type 2 inflammatory skin disease. Eighty-five to ninety percent of patients first develop symptoms before 5 years of age, which can often continue through adulthood. Symptoms include intense, persistent itch and skin lesions that cover much of the body, resulting in skin dryness, cracking, pain, redness or darkening, and crusting and oozing, along with increased risk of skin infections. In the U.S., more than 75,000 children aged 5 years and younger have uncontrolled moderate-to-severe disease and are most in need of new treatment options. Naimish Patel, M.D.Senior Vice President, Head of Global Development, Immunology and Inflammation, SanofiUntil today, treatment options in the U.S. for infants and children under the age of 6 suffering from moderate-to-severe atopic dermatitis have been limited to topical steroids which may be associated with significant safety risks when used long-term. This has left patients and their caregivers in desperate need of medicines that can better address the chronic, long-term nature of the disease. These young people, and their families, often struggle to cope with the significant impact itch can have on them. This approval means that Dupixent, with its well-established safety and efficacy profile, is now available to some of the youngest people living with this disease. George D. Yancopoulos, M.D., Ph.D.President and Chief Scientific Officer, RegeneronYoung children with moderate-to-severe atopic dermatitis are a significantly underserved population of patients, who spend vulnerable years of their lives suffering through the relentless and far-reaching effects of this chronic disease. Dupixent has changed the atopic dermatitis treatment paradigm significantly clearing skin and reducing itch by targeting an underlying cause of this disease without broadly suppressing the immune system. Todays approval brings the proven efficacy and, importantly, well-established safety profile of Dupixent to these young children, making it the first of its kind to be approved for any U.S. patient aged six months or older living with this debilitating disease. The FDA evaluated Dupixent under Priority Review, which is reserved for medicines that represent potentially significant improvements in efficacy or safety in treating serious conditions. The approval is based on data that include a Phase 3 trial evaluating Dupixent every four weeks (200 mg or 300 mg, based on body weight) plus low-potency topical corticosteroids (TCS) or TCS alone (placebo). The trial met the primary and all secondary endpoints. At 16 weeks, patients who received Dupixent with TCS experienced the following, compared to TCS alone: 28% achieved clear or almost-clear skin compared to 4% with placebo, the primary endpoint.53% achieved 75% or greater improvement in overall disease severity from baseline compared to 11% with placebo TCS alone, the co-primary endpoint outside of the U.S.48% achieved clinically meaningful reduction in itch compared to 9% with placebo. The safety profile of Dupixent observed through 16 weeks in children aged 6 months to 5 years was similar to the safety profile in patients 6 years and older with atopic dermatitis. The long-term safety profile of Dupixent in children aged 6 months to 5 years through 52 weeks was also similar to the safety profile observed in the pivotal trial and consistent with what was observed in older patients with atopic dermatitis. Hand-foot-and-mouth disease and skin papilloma were, respectively, reported in 5% and 2% of Dupixent patients aged 6 months to 5 years, and none of these cases led to treatment discontinuation. About the Dupixent Trial The Phase 3 randomized, double-blind, placebo-controlled trial evaluated the efficacy and safety of Dupixent added to standard-of-care low-potency TCS compared to low-potency TCS alone (placebo) in 162 children aged 6 months to 5 years with uncontrolled moderate-to-severe atopic dermatitis. The primary endpoints assessed the proportion of patients achieving an Investigator's Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) and 75% improvement in Eczema Area and Severity Index (EASI-75) at week 16. Additional outcome measures included itch reduction which was assessed using a caregiver-reported 0 to 10 Numerical Rating Scale, with a clinically meaningful improvement defined as 4-point improvement at week 16. Children who completed the trials were eligible to enroll in an open-label extension trial to assess the safety and efficacy of long-term treatment with Dupixent in this age group. About Dupixent Dupixent is administered as an injection under the skin (subcutaneous injection) at different injection sites. In patients aged 6 months to 5 years, Dupixent is administered with a pre-filled syringe every four weeks based on weight (200 mg for children 5 to <15 kg and 300 mg for children 15 to <30 kg). Dupixent is intended for use under the guidance of a healthcare professional and can be given in a clinic or at home by self-administration after training by a healthcare professional. In children younger than 12 years of age, Dupixent should be administered by a caregiver if given at home. Dupixent does not require initial lab testing or ongoing lab monitoring. Sanofi and Regeneron are committed to helping patients in the U.S. who are prescribed Dupixent gain access to the medicine and receive the support they may need with the DUPIXENT MyWay program. For more information, please call 1-844-DUPIXENT (1-844-387-4936) or visit www.DUPIXENT.com. Dupixent is approved for use in certain patients with atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP) or eosinophilic esophagitis in different age populations in a number of countries around the world. Dupixent is currently approved across these indications in the U.S. and for one or more of these indications in the European Union and Japan and more than 60 countries. More than 400,000 patients have been treated globally. Dupixent is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not an immunosuppressant. The Dupixent development program has shown significant clinical benefit and a decrease in type 2 inflammation in Phase 3 trials, establishing that IL-4 and IL-13 are key and central drivers of the type 2 inflammation that plays a major role in multiple related and often co-morbid diseases. These diseases include approved indications for Dupixent such as asthma, atopic dermatitis, CRSwNP and eosinophilic esophagitis, as well as investigational diseases such as prurigo nodularis. Dupilumab Development Program Dupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement. To date, dupilumab has been studied across more than 60 clinical trials involving more than 10,000 patients with various chronic diseases driven in part by type 2 inflammation. In addition to the currently approved indications, Sanofi and Regeneron are studying dupilumab in a broad range of diseases driven by type 2 inflammation or other allergic processes in Phase 3 trials, including prurigo nodularis, pediatric eosinophilic esophagitis, hand and foot atopic dermatitis, chronic inducible urticaria-cold, chronic spontaneous urticaria, chronic pruritis of unknown origin, chronic obstructive pulmonary disease with evidence of type 2 inflammation, chronic rhinosinusitis without nasal polyposis, allergic fungal rhinosinusitis, allergic bronchopulmonary aspergillosis and bullous pemphigoid. These potential uses of dupilumab are currently under clinical investigation, and the safety and efficacy in these conditions have not been fully evaluated by any regulatory authority. About Regeneron Regeneron is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led for nearly 35 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous FDA-approved treatments and product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, hematologic conditions, infectious diseases and rare diseases. Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite technologies, such as VelocImmune, which uses unique genetically humanized mice to produce optimized fully human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world. For additional information about the company, please visit www.regeneron.com or follow @Regeneron on Twitter. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY. Sanofi Media RelationsSally Bain|+ 1 617 834 6026 |sally.bain@sanofi.com Sanofi Investor RelationsEva Schaefer-Jansen | + 33 7 86 80 56 39 | eva.schaefer-jansen@sanofi.com Arnaud Delepine | + 33 06 73 69 36 93 | arnaud.delepine@sanofi.com Corentine Driancourt | + 33 06 40 56 92 | corentine.driancourt@sanofi.com Felix Lauscher | + 1 908 612 7239 | felix.lauscher@sanofi.com Priya Nanduri |+1 617 764 6418 | priya.nanduri@sanofi.com Nathalie Pham | + 33 07 85 93 30 17 | nathalie.pham@sanofi.com Regeneron Media RelationsHannah Kwagh | + 1 914 847 6314 | hannnah.kwagh@regeneron.com Regeneron Investor RelationsVesna Tosic | + 914 847 5443 | vesna.tosic@regeneron.com Sanofi Disclaimers or Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements are generally identified by the words "expects", "anticipates", "believes", "intends", "estimates", "plans" and similar expressions. Although Sanofi's management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. Any material effect of COVID-19 on any of the foregoing could also adversely impact us. This situation is changing rapidly and additional impacts may arise of which we are not currently aware and may exacerbate other previously identified risks. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in Sanofi's annual report on Form 20-F for the year ended December 31, 2021. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. Regeneron Forward-Looking Statements and Use of Digital MediaThis press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. (Regeneron or the Company), and actual events or results may differ materially from these forward-looking statements. Words such as anticipate, expect, intend, plan, believe, seek, estimate, variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the impact of SARS-CoV-2 (the virus that has caused the COVID-19 pandemic) on Regenerons business and its employees, collaborators, and suppliers and other third parties on which Regeneron relies, Regenerons and its collaborators ability to continue to conduct research and clinical programs, Regenerons ability to manage its supply chain, net product sales of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, Regenerons Products), and the global economy; the nature, timing, and possible success and therapeutic applications of Regenerons Products and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, Regenerons Product Candidates) and research and clinical programs now underway or planned, including without limitation Dupixent (dupilumab) for the treatment of moderate-to-severe atopic dermatitis in children aged 6 months to 5 years; uncertainty of the utilization, market acceptance, and commercial success of Regenerons Products (such as Dupixent) and Regenerons Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary), including the studies discussed or referenced in this press release, on any of the foregoing or any potential regulatory approval of Regenerons Products (such as Dupixent) and Regenerons Product Candidates; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regenerons Product Candidates and new indications for Regenerons Products, such as Dupixent for the treatment of hand and foot atopic dermatitis, prurigo nodularis, eosinophilic esophagitis, chronic inducible urticaria-cold, chronic spontaneous urticaria, bullous pemphigoid, chronic obstructive pulmonary disease with evidence of type 2 inflammation, chronic rhinosinusitis without nasal polyposis, allergic fungal rhinosinusitis, allergic bronchopulmonary aspergillosis, peanut allergy, and other potential indications; the ability of Regenerons collaborators, licensees, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regenerons Products and Regenerons Product Candidates; the ability of Regeneron to manage supply chains for multiple products and product candidates; safety issues resulting from the administration of Regenerons Products (such as Dupixent) and Regenerons Product Candidates in patients, including serious complications or side effects in connection with the use of Regenerons Products and Regenerons Product Candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict Regenerons ability to continue to develop or commercialize Regenerons Products and Regenerons Product Candidates, including without limitation Dupixent; ongoing regulatory obligations and oversight impacting Regenerons Products, research and clinical programs, and business, including those relating to patient privacy; the availability and extent of reimbursement of Regenerons Products from third-party payers, including private payer healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payers and new policies and procedures adopted by such payers; competing drugs and product candidates that may be superior to, or more cost effective than, Regenerons Products and Regenerons Product Candidates; the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators or licensees may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license, collaboration, or supply agreement, including Regenerons agreements with Sanofi, Bayer, and Teva Pharmaceutical Industries Ltd. (or their respective affiliated companies, as applicable) to be cancelled or terminated; and risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA (aflibercept) Injection, Dupixent, Praluent (alirocumab), and REGEN-COV (casirivimab and imdevimab)), other litigation and other proceedings and government investigations relating to the Company and/or its operations, the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regenerons business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regenerons filings with the U.S. Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2021 and its Form 10-Q for the quarterly period ended March 31, 2022. Any forward-looking statements are made based on managements current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise.Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regenerons media and investor relations website (http://newsroom.regeneron.com) and its Twitter feed (http://twitter.com/regeneron). Attachment Source: West Corporation Jun 02, 2022: Banco Santander Press Release: Sanofi grants Regeneron worldwide exclusive license rights to Libtayo (cemiplimab) Sanofi grants Regeneron worldwide exclusive license rights to Libtayo (cemiplimab) Sanofi will receive an upfront payment of $900 million, and an 11% royalty on worldwide net sales of LibtayoSanofi will also be entitled to a $100 million regulatory milestone payment as well as sales-related milestone payments of up to $100 million over the next two years Paris, June 2, 2022. Sanofi restructures its immuno-oncology collaboration with Regeneron Pharmaceuticals, Inc. Under the amended and restated license and collaboration agreement, Regeneron will obtain worldwide exclusive license rights to Libtayo. The Sanofi and Regeneron global immuno-oncology license and collaboration agreement was originally executed in 2015. Prior to today, the companies had split Libtayos worldwide operating profits equally and co-commercialized Libtayo in the U.S., with Sanofi solely responsible for commercialization in the rest of the world. Bill SiboldExecutive Vice President of Specialty Care & President of North America, SanofiOur diverse oncology portfolio doubled between 2019 and 2022 and now includes twelve compounds in clinical trials, each with a unique mechanism of action. Our early steps with Libtayo in immuno-oncology provided a strong foundation for our revitalized oncology efforts. Now, we are focused on leveraging our internal capabilities and advancing a new generation of oncology medicines. We continue to maintain a strong partnership with Regeneron in immunology, and will work closely with them on the seamless transition of Libtayo to ensure there is no impact for patients. Under the terms of the amended and restated immuno-oncology license and collaboration agreement,Sanofi will transfer the rights to develop, commercialize, and manufacture Libtayo entirely to Regeneron, on a worldwide basis, over the course of a defined transition period (to start upon receipt of any required governmental clearances worldwide). In exchange, Sanofiwill receive an upfront payment of $900 million, and an 11% royalty on worldwide net sales of Libtayo. Sanofi will also be entitled to a $100 million regulatory milestone payment upon the first approval by either the FDA or European Commission of Libtayo in combination with chemotherapy for first-line treatment of certain patients with NSCLC, as well as sales-related milestone payments of up to $100 million in total over the next two years. The transaction is subject to clearance under competition law and is expected to close in the third quarter of 2022. Regeneron will also accelerate reimbursement of the development balance associated with Regeneron and Sanofis separate Antibody Collaboration. Regeneron will increase from 10% to 20% the share of its profits that are paid to Sanofi to reimburse Sanofi-funded development expenses, until Regenerons share of the total cumulative development costs incurred under the collaboration has been reached. Sanofi continues to build its considerable expertise in oncology and has increased research and development capabilities, focusing on difficult to treat cancers including breast, blood, and lung. We are committed to translating scientific discoveries into potential new treatments and addressing critical gaps in cancer care. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Media RelationsSandrine Guendoul|+ 33 6 25 09 14 25 |sandrine.guendoul@sanofi.comSally Bain|+ 1 617 834 6026 |sally.bain@sanofi.comChrystel Baude|+ 33 6 70 98 70 59 |chrystel.baude@sanofi.comNicolas Obrist|+ 33 6 77 21 27 55 |nicolas.obrist@sanofi.comVictor Rouault|+ 33 6 70 93 71 40 |victor.rouault@sanofi.com Investor RelationsEva Schaefer-Jansen|+ 33 7 86 80 56 39 |eva.schaefer-jansen@sanofi.comArnaud Delepine|+ 33 6 73 69 36 93 | arnaud.delepine@sanofi.comCorentine Driancourt|+ 33 6 40 56 92 21 | corentine.driancourt@sanofi.comFelix Lauscher|+ 1908612 7239 | felix.lauscher@sanofi.comPriya Nanduri|+1 617 764 6418 | priya.nanduri@sanofi.com Nathalie Pham|+ 33 7 85 93 30 17 | nathalie.pham@sanofi.com Disclaimers or Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words expects, anticipates, believes, intends, estimates, plans and similar expressions. Although Sanofis management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofis ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. Any material effect of COVID-19 on any of the foregoing could also adversely impact us. This situation is changing rapidly and additional impacts may arise of which we are not currently aware and may exacerbate other previously identified risks. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under Risk Factors and Cautionary Statement Regarding Forward-Looking Statements in Sanofis annual report on Form 20-F for the year ended December 31, 2021. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. Attachment Source: West Corporation Jun 01, 2022: Banco Santander Press Release: FDA grants efanesoctocog alfa Breakthrough Therapy designation for hemophilia A FDA grants efanesoctocog alfa Breakthrough Therapy designation for hemophilia A Efanesoctocog alfa is the first factor VIII therapy to be awarded Breakthrough Therapy designation by the FDADesignation is based on XTEND-1 Phase 3 study data demonstrating a clinically meaningful prevention of bleeds and superiority in prevention of bleeding episodes compared to prior prophylaxis factor treatmentEfanesoctocog alfa is a novel and investigational factor VIII therapy designed to provide normal to near-normal factor activity levels for the majority of the week in a once-weekly prophylactic treatment regimen Paris and Stockholm June 1, 2022 The United States Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to efanesoctocog alfa (BIVV001) for the treatment of people with hemophilia A, a rare and life-threatening bleeding disorder, based on data from the pivotal XTEND-1 Phase 3 study. Sanofi and Sobi collaborate on the development and commercialization of efanesoctocog alfa. Breakthrough Therapy designation is designed to expedite the development and review of drugs in the US that target serious or life-threatening conditions. Drugs qualifying for this designation must show preliminary clinical evidence that the drug may demonstrate a substantial improvement on clinically significant endpoints over available therapies. John Reed, MD, PhDGlobal Head of Research and Development at Sanofi The Breakthrough Therapy designation highlights efanesoctocog alfas potential to transform treatment for people with hemophilia A by providing higher protection for longer duration. This potential new class of factor VIII therapy represents how we are boldly advancing science to address unmet needs for the hemophilia community. We are excited to work with regulatory authorities during the filing and review of this innovative therapy. Anders Ullman, MD, PhDHead of Research and Development and Chief Medical Officer at SobiThis designation supports the innovation of efanesoctocog alfa and acknowledges its potential to fulfill an unmet medical need for people living with hemophilia A. We are committed to transforming lives for people living with rare diseases, and this is a testament to the medical innovation that science can bring. Topline results from the pivotal XTEND-1 Phase 3 study demonstrate efanesoctocog alfa met the primary endpoint, showing a clinically meaningful prevention of bleeds in people with severe hemophilia A over a 52-week period. Importantly, the key secondary endpoint was also met, demonstrating that efanesoctocog alfa was superior to prior prophylactic factor VIII replacement therapy in preventing bleeding events based on an intra-patient comparison. Efanesoctocog alfa was well-tolerated, and inhibitor development to factor VIII was not detected. The most common treatment-emergent adverse events (>5% of participants overall) were headache, arthralgia, fall, and back pain. Data from the XTEND-1 Phase 3 study are expected to be shared at an upcoming medical meeting, and those data will serve as the basis for submission to FDA mid-year 2022. The FDA granted efanesoctocog alfa Orphan Drug designation in August 2017 and Fast Track designation in February 2021. The European Commission also granted efanesoctocog alfa Orphan Drug designation in June 2019. Regulatory submission in the EU will follow availability of data from the ongoing XTEND-Kids pediatric study, expected in 2023. Hemophilia A occurs in about one in 5,000 male births annually, and more rarely in females. It is a lifelong condition in which the ability of a persons blood to clot is impaired due to a coagulation factor deficiency. People with hemophilia can experience bleeding episodes that can cause pain, irreversible joint damage, and life-threatening hemorrhages. Unmet medical needs remain for people with hemophilia to strengthen protection, reduce treatment burden, and improve quality of life. About efanesoctocog alfa (BIVV001)Efanesoctocog alfa is a novel and investigational recombinant factor VIII therapy that is designed to extend protection from bleeds with once-weekly prophylactic dosing for people with hemophilia A. It builds on the innovative Fc fusion technology by adding a region of von Willebrand factor and XTEN polypeptides to extend its time in circulation. It is the first investigational factor VIII therapy that has been shown to break through the von Willebrand factor ceiling, which imposes a half-life limitation on current factor VIII therapies. Efanesoctocog alfa is currently under clinical investigation and its safety and efficacy have not been evaluated by any regulatory authority. About the Sanofi and Sobi collaborationSobi and Sanofi collaborate on the development and commercialization of Alprolixand Elocta/Eloctate.The companies also collaborate on the development and commercialization of efanesoctocog alfa, an investigational factor VIII therapy with the potential to provide high sustained factor activity levels with once-weekly dosing for people with hemophilia A. Sobi has final development and commercialization rights in the Sobi territory (essentially Europe, North Africa, Russia and most Middle Eastern markets). Sanofi has final development and commercialization rights in North America and all other regions in the world excluding the Sobi territory. About SobiSobi is a specialized international biopharmaceutical company transforming the lives of people with rare diseases. Providing sustainable access to innovative medicines in the areas of haematology, immunology and specialty care, Sobi has approximately 1,600 employees across Europe, North America, the Middle East and Asia. In 2021, revenue amounted to SEK 15.5 billion. Sobis share (STO:SOBI) is listed on Nasdaq Stockholm. More about Sobi at sobi.com, LinkedIn and YouTube. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Sanofi Contacts:Media RelationsSandrine Guendoul|+ 33 6 25 09 14 25 |sandrine.guendoul@sanofi.comSally Bain|+ 1 617 834 6026 |sally.bain@sanofi.com Investor RelationsEva Schaefer-Jansen|+ 33 7 86 80 56 39 |eva.schaefer-jansen@sanofi.comArnaud Delepine|+ 33 6 73 69 36 93 | arnaud.delepine@sanofi.comCorentine Driancourt|+ 33 6 40 56 92 21 | corentine.driancourt@sanofi.comFelix Lauscher|+ 1908612 7239 | felix.lauscher@sanofi.comPriya Nanduri|+1 617 764 6418 | priya.nanduri@sanofi.com Nathalie Pham|+ 33 7 85 93 30 17 | nathalie.pham@sanofi.com Sobi Contacts:Media RelationsFor Sobi Media contacts, click here. Investor RelationsFor details on how to contact the Sobi Investor Relations Team, click here. Sanofi Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words expects, anticipates, believes, intends, estimates, plans and similar expressions. Although Sanofis management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofis ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. Any material effect of COVID-19 on any of the foregoing could also adversely impact us. This situation is changing rapidly and additional impacts may arise of which we are not currently aware and may exacerbate other previously identified risks. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under Risk Factors and Cautionary Statement Regarding Forward-Looking Statements in Sanofis annual report on Form 20-F for the year ended December 31, 2021. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. Attachment Source: West Corporation May 31, 2022: Banco Santander Press Release: FDA accepts Dupixent (dupilumab) for priority review in adults with prurigo nodularis FDA accepts Dupixent (dupilumab) for priority review in adults with prurigo nodularis Dupixent would be the first and only medicine specifically indicated to treat prurigo nodularis in the U.S., if approved Acceptance marks another important step in advancing Dupixent for a broad range of diseases with underlying type 2 inflammation Paris and Tarrytown, N.Y. May 31, 2022. The U.S. Food and Drug Administration (FDA) has accepted for priority review the supplemental Biologics License Application (sBLA) for Dupixent (dupilumab) to treat adults with prurigo nodularis, a chronic inflammatory skin disease that causes extreme itch and skin lesions. The target action date for the FDA decision is September 30, 2022. The sBLA is supported by data from two pivotal Phase 3 trials evaluating the efficacy and safety of Dupixent in patients 18 years and older with uncontrolled prurigo nodularis (PRIME2 and PRIME). Both trials met the primary and key secondary endpoints, showing Dupixent significantly improved disease signs and symptoms compared to placebo, including reduction in itch and skin lesions. The safety results from these trials were generally consistent with the known safety profile of Dupixent in atopic dermatitis. The adverse event more commonly observed with Dupixent was conjunctivitis. The FDA grants priority review to therapies that have the potential to provide significant improvements in the treatment, diagnosis or prevention of serious conditions. Additional regulatory filings outside of the US are also planned in 2022. The potential use of Dupixent in prurigo nodularis is currently under clinical development, and the safety and efficacy have not been fully evaluated by any regulatory authority. About Prurigo NodularisPeople with prurigo nodularis experience intense, persistent itch, with thick skin lesions (called nodules) that can cover most of the body. Prurigo nodularis is often described as painful with burning, stinging and tingling of the skin. The impact of uncontrolled prurigo nodularis on quality of life is one of the highest among inflammatory skin diseases due to the extreme itch and is comparable to other debilitating chronic diseases that can negatively affect mental health, activities of daily living and social interactions. High-potency topical steroids are commonly prescribed but are associated with safety risks if used long term. There are approximately 75,000 people in the U.S. who are unable to control their disease with systemic therapy and are most in need of a treatment option. About DupixentDupixent is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not an immunosuppressant. The Dupixent development program has shown significant clinical benefit and a decrease in type 2 inflammation in Phase 3 trials, establishing that IL-4 and IL-13 are key and central drivers of the type 2 inflammation that plays a major role in multiple related and often co-morbid diseases. These diseases include approved indications for Dupixent such as asthma, atopic dermatitis, chronic rhinosinusitis with nasal polyposis and eosinophilic esophagitis, as well as investigational diseases such as prurigo nodularis. Dupixent is approved for use in certain patients with atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis and eosinophilic esophagitis in different age populations in a number of countries around the world. Dupixent is currently approved across these indications in the U.S. and for one or more of these indications in the European Union, Japan and more than 60 countries. More than 400,000 patients have been treated with Dupixent globally. Dupilumab Development ProgramDupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement. To date, dupilumab has been studied in more than 60 clinical trials involving more than 10,000 patients with various chronic diseases driven in part by type 2 inflammation. In addition to the currently approved indications, Sanofi and Regeneron are studying dupilumab in a broad range of diseases driven by type 2 inflammation or other allergic processes in Phase 3 trials, including prurigo nodularis, pediatric eosinophilic esophagitis, hand and foot atopic dermatitis, chronic inducible urticaria-cold, chronic spontaneous urticaria, chronic pruritis of unknown origin, chronic obstructive pulmonary disease with evidence of type 2 inflammation, chronic rhinosinusitis without nasal polyposis, allergic fungal rhinosinusitis, allergic bronchopulmonary aspergillosis and bullous pemphigoid. These potential uses of dupilumab are currently under clinical investigation, and the safety and efficacy in these conditions have not been fully evaluated by any regulatory authority. About Regeneron Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, hematologic conditions, infectious diseases and rare diseases. Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite technologies, such as VelocImmune, which uses unique genetically humanized mice to produce optimized fully human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world. For additional information about the company, please visit www.regeneron.com or follow @Regeneron on Twitter. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions.Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Sanofi Media RelationsSally Bain|+ 1 617 834 6026 |sally.bain@sanofi.com Sanofi Investor RelationsEva Schaefer-Jansen | + 33 7 86 80 56 39 | eva.schaefer-jansen@sanofi.com Arnaud Delepine | + 33 06 73 69 36 93 | arnaud.delepine@sanofi.com Corentine Driancourt | + 33 06 40 56 92 | corentine.driancourt@sanofi.com Felix Lauscher | + 1 908 612 7239 | felix.lauscher@sanofi.com Priya Nanduri | |+1 617 764 6418 priya.nanduri@sanofi.com Nathalie Pham | + 33 07 85 93 30 17 | nathalie.pham@sanofi.com Regeneron Media RelationsHannah Kwagh | + 1 914 847 6314 | hannah.kwagh@regeneron.com Regeneron Investor RelationsVesna Tosic | + 914 847 5443 | vesna.tosic@regeneron.com Sanofi Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements are generally identified by the words expects, anticipates, believes, intends, estimates, plans and similar expressions. Although Sanofis management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. Any material effect of COVID-19 on any of the foregoing could also adversely impact us. This situation is changing rapidly and additional impacts may arise of which we are not currently aware and may exacerbate other previously identified risks. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under Risk Factors and Cautionary Statement Regarding Forward-Looking Statements in Sanofis annual report on Form 20-F for the year ended December 31, 2021. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. Regeneron Forward-Looking Statements and Use of Digital MediaThis press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. (Regeneron or the Company), and actual events or results may differ materially from these forward-looking statements. Words such as anticipate, expect, intend, plan, believe, seek, estimate, variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the impact of SARS-CoV-2 (the virus that has caused the COVID-19 pandemic) on Regenerons business and its employees, collaborators, and suppliers and other third parties on which Regeneron relies, Regenerons and its collaborators ability to continue to conduct research and clinical programs, Regenerons ability to manage its supply chain, net product sales of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, Regenerons Products), and the global economy; the nature, timing, and possible success and therapeutic applications of Regenerons Products and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, Regenerons Product Candidates) and research and clinical programs now underway or planned, including without limitation Dupixent (dupilumab) for the treatment of prurigo nodularis; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regenerons Product Candidates and new indications for Regenerons Products, such as Dupixent for the treatment of prurigo nodularis (including potential approval by the U.S. Food and Drug Administration based on the supplemental Biologics License Application discussed in this press release), pediatric atopic dermatitis, hand and foot atopic dermatitis, chronic obstructive pulmonary disease with evidence of type 2 inflammation, pediatric eosinophilic esophagitis, bullous pemphigoid, chronic spontaneous urticaria, chronic pruritis of unknown origin, chronic inducible urticaria-cold, chronic rhinosinusitis without nasal polyposis, allergic fungal rhinosinusitis, allergic bronchopulmonary aspergillosis, and other potential indications; uncertainty of the utilization, market acceptance, and commercial success of Regenerons Products (such as Dupixent) and Regenerons Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary), including the studies discussed or referenced in this press release, on any of the foregoing or any potential regulatory approval of Regenerons Products (such as Dupixent) and Regenerons Product Candidates; the ability of Regenerons collaborators, licensees, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regenerons Products and Regenerons Product Candidates; the ability of Regeneron to manage supply chains for multiple products and product candidates; safety issues resulting from the administration of Regenerons Products (such as Dupixent) and Regenerons Product Candidates in patients, including serious complications or side effects in connection with the use of Regenerons Products and Regenerons Product Candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict Regenerons ability to continue to develop or commercialize Regenerons Products and Regenerons Product Candidates, including without limitation Dupixent; ongoing regulatory obligations and oversight impacting Regenerons Products, research and clinical programs, and business, including those relating to patient privacy; the availability and extent of reimbursement of Regenerons Products from third-party payers, including private payer healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payers and new policies and procedures adopted by such payers; competing drugs and product candidates that may be superior to, or more cost effective than, Regenerons Products and Regenerons Product Candidates; the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators or licensees may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license, collaboration, or supply agreement, including Regenerons agreements with Sanofi, Bayer, and Teva Pharmaceutical Industries Ltd. (or their respective affiliated companies, as applicable) to be cancelled or terminated; and risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA (aflibercept) Injection, Dupixent, Praluent (alirocumab), and REGEN-COV (casirivimab and imdevimab)), other litigation and other proceedings and government investigations relating to the Company and/or its operations, the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regenerons business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regenerons filings with the U.S. Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2021 and its Form 10-Q for the quarterly period ended March 31, 2022. Any forward-looking statements are made based on managements current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise. Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regenerons media and investor relations website (http://newsroom.regeneron.com) and its Twitter feed (http://twitter.com/regeneron). Attachment Source: West Corporation May 30, 2022: Banco Santander Press Release: Update on Cialis Rx-to-OTC Switch Actual Use Trial Update on Cialis Rx-to-OTC Switch Actual Use Trial Paris. May 30, 2022. The U.S. Food and Drug Administration has informed Sanofi that its planned Actual Use Trial (AUT) to support the Rx-to-OTC switch for Cialis (tadalafil) has been placed on clinical hold due to matters surrounding the protocol design. Sanofis AUT has not yet recruited any patients. Sanofi continues to work with FDA to move the Cialis program forward and will engage the Agency in upcoming meetings as we determine next steps. About Cialis Currently only available with a prescription, Cialis is a tablet taken to treat erectile dysfunction (ED), the signs and symptoms of benign prostatic hyperplasia (BPH), and both ED and the signs and symptoms of BPH. Cialis is the only PDE-5 inhibitor treatment that offers men a choice when it comes to treatment for erectile dysfunction - Cialis for use as needed and Cialis for once daily use. To learn more about Cialis, visit www.cialis.com.Cialis is not for women or children. It is important to note that Cialis is not to be taken with medicines called "nitrates" such as isosorbide dinitrate or isosorbide mononitrate which are often prescribed for chest pain; or with recreational drugs called "poppers" like amyl or butyl nitrite, as the combination may cause an unsafe drop in blood pressure; or if allergic to Cialis or Adcirca (tadalafil), or any of its ingredients. Anyone who experiences any symptoms of an allergic reaction, such as rash, hives, swelling of the lips, tongue or throat, or difficulty breathing or swallowing, should call a healthcare provider or get help right away. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Media RelationsSandrine Guendoul|+ 33 6 25 09 14 25 |sandrine.guendoul@sanofi.comEvan Berland |+ 1 215 432 0234 |evan.berland@sanofi.com Investor RelationsEva Schaefer-Jansen|+ 33 7 86 80 56 39 |eva.schaefer-jansen@sanofi.comArnaud Delepine|+ 33 6 73 69 36 93 | arnaud.delepine@sanofi.comCorentine Driancourt|+ 33 6 40 56 92 21 | corentine.driancourt@sanofi.comFelix Lauscher|+ 1908612 7239 | felix.lauscher@sanofi.comPriya Nanduri|+1 617 764 6418 | priya.nanduri@sanofi.com Nathalie Pham|+ 33 7 85 93 30 17 | nathalie.pham@sanofi.com Sanofi Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words expects, anticipates, believes, intends, estimates, plans and similar expressions. Although Sanofis management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofis ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. Any material effect of COVID-19 on any of the foregoing could also adversely impact us. This situation is changing rapidly and additional impacts may arise of which we are not currently aware and may exacerbate other previously identified risks. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under Risk Factors and Cautionary Statement Regarding Forward-Looking Statements in Sanofis annual report on Form 20-F for the year ended December 31, 2021. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. Attachment Source: West Corporation May 20, 2022: Banco Santander Press Release: FDA approves Dupixent (dupilumab) as first treatment for adults and children aged 12 and older with eosinophilic esophagitis FDA approves Dupixent (dupilumab) as first treatment for adults and children aged 12 and older with eosinophilic esophagitis Dupixent is the first and only medicine indicated to treat eosinophilic esophagitis in the United States; approval granted more than two months ahead of FDAs Priority Review action date Dupixent 300 mg weekly significantly improved signs and symptoms of eosinophilic esophagitis compared to placebo in a Phase 3 trial, underscoring the role of type 2 inflammation in this complex diseaseEosinophilic esophagitis is a chronic, progressive inflammatory disease driven by type 2 inflammation that damages the esophagus and prevents it from working properlyApproval represents first indication for Dupixent in a gastrointestinal disease and fourth disease indicated overall Paris and Tarrytown, N.Y. May 20, 2022. The U.S. Food and Drug Administration (FDA) has approved Dupixent (dupilumab) 300 mg weekly to treat patients with eosinophilic esophagitis (EoE) aged 12 years and older, weighing at least 40 kg. With this approval, Dupixent becomes the first and only medicine specifically indicated to treat EoE in the United States. A regulatory filing for EoE is under review by the European Medicines Agency, and submissions to regulatory authorities in additional countries are planned by the end of 2022. Mary Jo StrobelExecutive Director, American Partnership for Eosinophilic Disorders (APFED)We have waited a long time for an FDA-approved treatment option for eosinophilic esophagitis - an underdiagnosed and misunderstood disease of the esophagus that can make it extremely challenging and uncomfortable to eat and swallow. Before today, there were no approved treatments specifically for eosinophilic esophagitis, resulting in many people needing to maintain a strict diet and live in constant fear of food getting stuck in their throat. We welcome therapeutic options that can provide much-needed relief for these patients. EoE is a chronic inflammatory disease driven by type 2 inflammation that damages the esophagus and prevents it from working properly. For people with EoE, swallowing even small amounts of food can be a painful and worrisome choking experience. They are often left to contend with the frustration and anxiety of a constantly evolving list of foods to avoid, a poor quality of life and a higher risk of depression. In cases where EoE causes the esophagus to narrow, forced and potentially painful dilation (physical expansion) of the esophagus may be needed. In severe cases, a feeding tube may be the only option to ensure proper caloric intake and adequate nutrition. About 160,000 patients are living with EoE in the U.S. These individuals are currently treated with therapies not specifically approved for the disease, of whom approximately 48,000 continue to experience symptoms despite multiple treatments. John Reed, M.D., Ph.D.Global Head of Research and Development, SanofiEating regularly throughout the day is essential, yet significant difficulty swallowing food is a common symptom for people living with eosinophilic esophagitis. This can be incredibly upsetting and often leads to fear of pain or choking with every meal, every day. A large unmet need exists for treatment options that can provide meaningful symptom relief. Our Phase 3 clinical program showed that Dupixent weekly improved the ability to swallow and reduced inflammation in the esophagus, underscoring the role of type 2 inflammation in this complex disease. This is a landmark FDA approval for patients and their caregivers who now have a new option for treating this devastating disease. George D. Yancopoulos, M.D., Ph.D.President and Chief Scientific Officer, RegeneronIt is gratifying that Dupixent, a medicine that we invented in our laboratories, is now approved in yet another disease marked by allergic or type 2 inflammation, namely eosinophilic esophagitis. Eosinophilic esophagitis can be debilitating for patients, by inflaming and damaging the esophagus and limiting the ability to eat normally. Dupixent is the first and only medicine specifically indicated to treat eosinophilic esophagitis in the United States, and todays approval marks the fourth disease for which Dupixent is now indicated, reinforcing the promise of targeting IL-4 and IL-13 to effectively treat diseases with underlying type 2 inflammation. The FDA approval is based on data from a Phase 3 trial with two parts (Part A and Part B) evaluating the efficacy and safety of Dupixent 300 mg weekly, compared to placebo, in patients aged 12 years and older with EoE, weighing at least 40 kg. After 24 weeks, patients treated with Dupixent 300 mg weekly experienced the following changes in Part A and Part B, respectively: 69% and 64% reduction in disease symptoms from baseline compared to 32% and 41% for placebo. Disease symptoms were measured by the Dysphagia Symptom Questionnaire (DSQ), where patients receiving Dupixent experienced a 21.9- and 23.8-point clinically meaningful improvement compared to 9.6- and 13.9-point improvement for placebo. Approximately 10 times as many patients achieved histological disease remission (peak esophageal intraepithelial eosinophil count of 6 eos/high power field [hpf]) compared to placebo: 60% and 59% compared to 5% and 6% of patients receiving placebo. The safety results were generally consistent with the known safety profile of Dupixent in its approved indications. Pooled adverse events from Parts A and B that were more commonly (2%) observed with Dupixent than placebo were injection site reactions (38% Dupixent, 33% placebo), upper respiratory tract infections (18% Dupixent, 10% placebo), arthralgia (2% Dupixent, 1% placebo) and herpes viral infections (2% Dupixent, 1% placebo). The FDA evaluated the Dupixent application under Priority Review, which is granted to therapies that have the potential to provide significant improvements in the treatment, diagnosis or prevention of serious conditions. About the Dupixent Eosinophilic Esophagitis Trial The Phase 3 randomized, double-blind, placebo-controlled trial evaluated the efficacy and safety of Dupixent in patients aged 12 years and older with EoE. Part A enrolled 81 patients and evaluated Dupixent 300 mg weekly (42 treated with Dupixent and 39 with placebo). Part B enrolled 159 patients and evaluated Dupixent 300 mg weekly (80 with Dupixent and 79 with placebo). At 24 weeks, the co-primary endpoints in Parts A and B assessed patient-reported measures of difficulty swallowing (change from baseline in the DSQ on a 0-84 scale) and esophageal inflammation (proportion of patients achieving histological disease remission, defined as peak esophageal intraepithelial eosinophil count of 6 eos/hpf). About Dupixent Dupixent is administered as an injection under the skin (subcutaneous injection) at different injection sites. In patients aged 12 years and older, weighing at least 40 kg, with EoE, Dupixent is administered as a 300 mg dose with a pre-filled syringe or pen every week. Dupixent is intended for use under the guidance of a healthcare professional and can be given in a clinic or at home by self-administration after training by a healthcare professional. In children aged 12 to 17 years, Dupixent should be administered under the supervision of an adult. Dupixent is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not an immunosuppressant. The Dupixent development program has shown significant clinical benefit and a decrease in type 2 inflammation in Phase 3 trials, establishing that IL-4 and IL-13 are key and central drivers of the type 2 inflammation that plays a major role in multiple related and often co-morbid diseases. These diseases include approved indications for Dupixent such as asthma, atopic dermatitis, chronic rhinosinusitis with nasal polyposis (CRSwNP) and eosinophilic esophagitis, as well as investigational diseases such as prurigo nodularis. Regeneron and Sanofi are committed to helping patients in the U.S. who are prescribed Dupixent gain access to the medicine and receive the support they may need with the DUPIXENT MyWay program. For more information, please call 1-844-DUPIXENT (1-844-387-4936) or visit www.DUPIXENT.com. Dupixent is also approved for use in certain patients with atopic dermatitis, asthma or CRSwNP in different age populations in a number of countries around the world, including the U.S., European Union and Japan. Dupixent is currently approved for one or more of these indications in more than 60 countries, and more than 400,000 patients have been treated globally. Dupilumab Development Program Dupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement. To date, dupilumab has been studied across more than 60 clinical trials involving more than 10,000 patients with various chronic diseases driven in part by type 2 inflammation. In addition to the currently approved indications, Sanofi and Regeneron are studying dupilumab in a broad range of diseases driven by type 2 inflammation or other allergic processes including pediatric atopic dermatitis (6 months to 5 years of age, Phase 3), hand and foot atopic dermatitis (Phase 3), chronic obstructive pulmonary disease with evidence of type 2 inflammation (Phase 3), pediatric eosinophilic esophagitis (Phase 3), bullous pemphigoid (Phase 3), prurigo nodularis (Phase 3), chronic spontaneous urticaria (Phase 3), chronic pruritis of unknown origin (Phase 3), chronic inducible urticaria-cold (Phase 3), chronic rhinosinusitis without nasal polyposis (Phase 3), allergic fungal rhinosinusitis (Phase 3) and allergic bronchopulmonary aspergillosis (Phase 3). These potential uses of dupilumab are currently under clinical investigation, and the safety and efficacy in these conditions have not been fully evaluated by any regulatory authority. About Regeneron Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for nearly 35 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, hematologic conditions, infectious diseases and rare diseases. Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite technologies, such as VelocImmune, which uses unique genetically humanized mice to produce optimized fully human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world. For additional information about the company, please visit www.regeneron.com or follow @Regeneron on Twitter. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY. Sanofi Media RelationsSally Bain|+ 1 617 834 6026 |sally.bain@sanofi.com Sanofi Investor RelationsEva Schaefer-Jansen | + 33 7 86 80 56 39 | eva.schaefer-jansen@sanofi.com Arnaud Delepine | + 33 06 73 69 36 93 | arnaud.delepine@sanofi.com Corentine Driancourt | + 33 06 40 56 92 | corentine.driancourt@sanofi.com Felix Lauscher | + 1 908 612 7239 | felix.lauscher@sanofi.com Priya Nanduri |+617 764 6418 | priya.nanduri@sanofi.com Nathalie Pham | + 33 07 85 93 30 17 | nathalie.pham@sanofi.com Regeneron Media RelationsAshleigh Dixon | + 1 914 374 2422 | ashleigh.dixon@regeneron.com Regeneron Investor RelationsVesna Tosic | + 914 847 5443 | vesna.tosic@regeneron.com Sanofi Disclaimers or Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements are generally identified by the words "expects", "anticipates", "believes", "intends", "estimates", "plans" and similar expressions. Although Sanofi's management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. Any material effect of COVID-19 on any of the foregoing could also adversely impact us. This situation is changing rapidly and additional impacts may arise of which we are not currently aware and may exacerbate other previously identified risks. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in Sanofi's annual report on Form 20-F for the year ended December 31, 2021. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. Regeneron Forward-Looking Statements and Use of Digital Media This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. (Regeneron or the Company), and actual events or results may differ materially from these forward-looking statements. Words such as anticipate, expect, intend, plan, believe, seek, estimate, variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the impact of SARS-CoV-2 (the virus that has caused the COVID-19 pandemic) on Regenerons business and its employees, collaborators, and suppliers and other third parties on which Regeneron relies, Regenerons and its collaborators ability to continue to conduct research and clinical programs, Regenerons ability to manage its supply chain, net product sales of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, Regenerons Products), and the global economy; the nature, timing, and possible success and therapeutic applications of Regenerons Products and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, Regenerons Product Candidates) and research and clinical programs now underway or planned, including without limitation Dupixent (dupilumab) for the treatment of eosinophilic esophagitis; uncertainty of the utilization, market acceptance, and commercial success of Regenerons Products (such as Dupixent) and Regenerons Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary), including the studies discussed or referenced in this press release, on any of the foregoing or any potential regulatory approval of Regenerons Products (such as Dupixent) and Regenerons Product Candidates; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regenerons Product Candidates and new indications for Regenerons Products, such as Dupixent for the treatment of pediatric atopic dermatitis, chronic obstructive pulmonary disease with evidence of type 2 inflammation, pediatric eosinophilic esophagitis, bullous pemphigoid, prurigo nodularis, chronic spontaneous urticaria, chronic inducible urticaria-cold, chronic rhinosinusitis without nasal polyposis, allergic fungal rhinosinusitis, allergic bronchopulmonary aspergillosis, peanut allergy, and other potential indications; the ability of Regenerons collaborators, licensees, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regenerons Products and Regenerons Product Candidates; the ability of Regeneron to manage supply chains for multiple products and product candidates; safety issues resulting from the administration of Regenerons Products (such as Dupixent) and Regenerons Product Candidates in patients, including serious complications or side effects in connection with the use of Regenerons Products and Regenerons Product Candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict Regenerons ability to continue to develop or commercialize Regenerons Products and Regenerons Product Candidates, including without limitation Dupixent; ongoing regulatory obligations and oversight impacting Regenerons Products, research and clinical programs, and business, including those relating to patient privacy; the availability and extent of reimbursement of Regenerons Products from third-party payers, including private payer healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payers and new policies and procedures adopted by such payers; competing drugs and product candidates that may be superior to, or more cost effective than, Regenerons Products and Regenerons Product Candidates; the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators or licensees may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license, collaboration, or supply agreement, including Regenerons agreements with Sanofi, Bayer, and Teva Pharmaceutical Industries Ltd. (or their respective affiliated companies, as applicable) to be cancelled or terminated; and risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA (aflibercept) Injection, Dupixent, Praluent (alirocumab), and REGEN-COV (casirivimab and imdevimab)), other litigation and other proceedings and government investigations relating to the Company and/or its operations, the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regenerons business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regenerons filings with the U.S. Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2021 and its Form 10-Q for the quarterly period ended March 31, 2022. Any forward-looking statements are made based on managements current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise.Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regenerons media and investor relations website (http://newsroom.regeneron.com) and its Twitter feed (http://twitter.com/regeneron). Attachment Source: West Corporation May 15, 2022: Banco Santander Press Release: Sarclisa (isatuximab) combination provides unprecedented median progression free survival in patients with relapsed multiple myeloma receiving a proteasome inhibitor therapy Sarclisa (isatuximab) combination provides unprecedented median progression free survival in patients with relapsed multiple myeloma receiving a proteasome inhibitor therapy Latest results of the Phase 3 IKEMA trial demonstrate the longest median progression free survival (mPFS) on a proteasome inhibitor backbone in patients who relapsed after a prior therapy, including lenalidomideThe median progression free survival, increased from 19.2 months to 35.7 months when Sarclisa was added to carfilzomib and dexamethasoneFurther analysis, following U.S. Food and Drug Administration recommendations on censoring rules, showed mPFS increased from 20.8 to 41.7 months when Sarclisa was added to carfilzomib and dexamethasone PARIS, May 15, 2022. Latest results from the Phase 3 IKEMA clinical trial evaluating Sarclisa (isatuximab) in combination with carfilzomib and dexamethasone (Kd) demonstrated a median progression free survival (mPFS) of 35.7 months (Hazard Ratio [HR] 0.58; 95% Confidence Interval [CI]: 25.8 to 44.0; n=179), compared to 19.2 months in patients treated with Kd alone (95% CI: 15.8 to 25.1; n=123), as evaluated by an Independent Review Committee. These results, presented at the Controversies in Multiple Myeloma World Congress, represent the longest mPFS among studies investigating a proteasome inhibitor backbone in the second-line setting for the treatment of relapsed multiple myeloma (MM). These data will also be presented at the European Society for Medical Oncology on May 19. Philippe Moreau, MDHead of the Department of Hematology, University Hospital of Nantes, FranceThe increase in progression free survival, observed consistently across all subgroups, when adding Sarclisa to carfilzomib and dexamethasone is remarkable in patients with relapsed multiple myeloma in a proteasome inhibitor combination. Relapse is common in multiple myeloma, creating the need for differentiated second-line treatments that provide patients a longer period of time without disease progression. This updated analysis reinforces the potential for Sarclisa to become a new standard of care for patients with relapsed multiple myeloma. A PFS analysis following the U.S. Food and Drug Administration recommendations on censoring rules, as applied in the approved U.S. prescribing information, showed an mPFS of 41.7 months for Sarclisa added to Kd (Sarclisa combination therapy) compared to 20.8 months in patients treated with Kd alone (HR 0.59; 95% CI: 27.1 to Not Calculable [NC]). Time to next treatment for patients treated with Sarclisa combination therapy was 44.9 months (HR 0.55; 95% CI: 31.6 to NC) versus those treated with Kd alone at 25 months (95% CI: 17.9 to 31.3). Time to next treatment measured the interval from the date of randomization1 to the date of commencement of the next line of therapy, thereby allowing for measurement of the period of therapeutic benefit.2 Peter C. Adamson, MDGlobal Head of Oncology Clinical Development and Pediatric Innovation at SanofiTo observe progression free survival of more than three years in patients with relapsed multiple myeloma when Sarclisa was added to a proteasome inhibitor backbone of therapy is unprecedented and reinforces our confidence in Sarclisa as a potential best in class anti-CD38 antibody. The safety and tolerability of Sarclisa observed in this analysis were consistent with the safety profile of Sarclisa in other clinical trials, with no new safety signals observed. For the Sarclisa combination therapy and Kd groups, the most common adverse events were infusion related reaction (45.8%, 3.3%), diarrhea (39.5%, 32%), hypertension (37.9%, 35.2%), upper respiratory tract infection (37.3%, 27%), fatigue (31.6%, 20.5%), dyspnoea (30.5%, 22.1%), pneumonia (27.1%, 21.3%), back pain (25.4%, 21.3%), insomnia (25.4%, 24.6%), and bronchitis (24.3%, 12.3%). Treatment exposure in the Sarclisa combination therapy arm was 30 weeks longer than in the control arm. Treatment emergent adverse events (TEAEs) of Grade 3 were reported in 83.6% of patients treated with Sarclisa combination therapy and in 73% of those treated with Kd alone. Serious TEAEs were higher in the Sarclisa combination therapy arm versus Kd alone (70.1% versus 59.8%). No difference was observed after exposure adjustment. These results will be discussed with regulatory authorities at a future date. About the IKEMA trial The randomized, multi-center, open label Phase 3 IKEMA clinical trial enrolled 302 patients with relapsed MM across 69 centers spanning 16 countries. All study participants had received one to three prior anti-myeloma therapies. During the trial, Sarclisa was administered through an intravenous infusion at a dose of 10mg/kg once weekly for four weeks, then every other week for 28-day cycles in combination with carfilzomib twice weekly at the 20/56mg/m2 dose and dexamethasone at the standard dose for the duration of treatment. The primary endpoint of IKEMA was progression free survival. Secondary endpoints included overall response rate, the rate of complete response or better, the rate of very good partial response or better, rate of minimal residual disease-negativity, overall survival and safety.3 About Sarclisa Sarclisa is a monoclonal antibody that targets a specific epitope on the CD38 receptor on multiple myeloma (MM) cells. It is designed to work through multiple mechanisms of action including programmed tumor cell death (apoptosis) and immunomodulatory activity. CD38 is highly and uniformly expressed on the surface of MM cells, making it a potential target for antibody-based therapeutics such as Sarclisa. Based on the Phase 3 ICARIA-MM study, Sarclisa is approved in a number of countries, including the U.S. and EU, in combination with pomalidomide and dexamethasone for the treatment of patients with relapsed refractory MM (RRMM) who have received 2 prior therapies, including lenalidomide and a proteasome inhibitor. Based on the Phase 3 IKEMA study, Sarclisa is also approved in multiple countries in combination with carfilzomib and dexamethasone, including in the U.S. for the treatment of patients with RRMM who have received 13 prior lines of therapy and in the European Union for patients with MM who have received at least 1 prior therapy. In the U.S., the generic name for Sarclisa is isatuximab-irfc, with irfc as the suffix designated in accordance with Nonproprietary Naming of Biological Products Guidance for Industry issued by the U.S. Food and Drug Administration (FDA). Sarclisa continues to be evaluated in multiple ongoing Phase 3 clinical trials in combination with current standard treatments across the MM treatment continuum. It is also under investigation for the treatment of other hematologic malignancies and solid tumors. The safety and efficacy of these additional uses have not been reviewed by any regulatory authority worldwide. For more information on Sarclisa clinical trials, please visit www.clinicaltrials.gov. About multiple myeloma MM is the second most common hematologic malignancy,4 with more than 130,000 new diagnoses of MM worldwide yearly.5 Despite available treatments, MM remains an incurable malignancy and is associated with significant patient burden. Since MM does not have a cure, most patients will relapse. Relapsed MM is the term for when the cancer returns after treatment or a period of remission. Refractory MM refers to when the cancer does not respond or no longer responds to therapy. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Media RelationsSally Bain|+ 1 617 834 6026 |sally.bain@sanofi.comKate Conway |+ 617 685 5326 | kate.conway@sanofi.com Investor RelationsEva Schaefer-Jansen|+ 33 7 86 80 56 39 |eva.schaefer-jansen@sanofi.comArnaud Delepine|+ 33 6 73 69 36 93 | arnaud.delepine@sanofi.comCorentine Driancourt|+ 33 6 40 56 92 21 | corentine.driancourt@sanofi.comFelix Lauscher|+ 1908612 7239 | felix.lauscher@sanofi.comPriya Nanduri|+1 908 981 5560 | priya.nanduri@sanofi.com Nathalie Pham|+ 33 7 85 93 30 17 | nathalie.pham@sanofi.com Sanofi Forward-Looking Statements This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words expects, anticipates, believes, intends, estimates, plans and similar expressions. Although Sanofis management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofis ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. Any material effect of COVID-19 on any of the foregoing could also adversely impact us. This situation is changing rapidly and additional impacts may arise of which we are not currently aware and may exacerbate other previously identified risks. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under Risk Factors and Cautionary Statement Regarding Forward-Looking Statements in Sanofis annual report on Form 20-F for the year ended December 31, 2021. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. 1 ClincalTrials.gov. Identifier # NCT03275285.https://www.clinicaltrials.gov/ct2/show/NCT03275285?term=IKEMA&draw=2&rank=1. Accessed April 2022. 2 Campbell. Time to Next Treatment as a Meaningful Endpoint for Trials of Primary Cutaneous Lymphoma. Cancers vol. 12,8 2311. 17 Aug. 2020, doi:10.3390/cancers12082311.3 ClinicalTrials.gov. Identifier # NCT03275285. https://www.clinicaltrials.gov/ct2/show/NCT03275285?cond=NCT03275285&draw=2&rank=1. Accessed April 2022.4 Kazandjian. Multiple myeloma epidemiology and survival: A unique malignancy. Semin Oncol. 2016;43(6):676-681. doi:10.1053/j/seminoncol.2016.11.004.5 International Myeloma Foundation. Myeloma Action Month. https://mam.myeloma.org/learn-more-about-multiple-myeloma/. Accessed April 2022. Attachment Source: West Corporation May 11, 2022: Banco Santander Press Release: New nirsevimab data analyses reinforce efficacy against RSV New nirsevimab data analyses reinforce efficacy against RSV A prespecified pooled analysis of Phase 3 and Phase 2b data demonstrated an efficacy of 79.5% against medically attended lower respiratory tract infections (LRTI), including hospitalizations, caused by respiratory syncytial virus (RSV)1Nirsevimab is the first investigational immunization designed to protect all infants across the RSV season with a single doseTwo analyses are being presented at the European Society for Paediatric Infectious Diseases meeting1,2 Paris, May 11, 2022. Results from a prespecified pooled analysis of the pivotal Phase 3 MELODY and Phase 2b nirsevimab trials demonstrated an efficacy (relative risk reduction versus placebo) of 79.5% (95% CI 65.9 to 87.7; P<0.0001) against medically attended LRTI, such as bronchiolitis or pneumonia, caused by RSV in infants born at term or preterm entering their first RSV season.1 In a separate pooled post-hoc analysis of the trials, blood samples taken from infants dosed with nirsevimab exhibited RSV neutralizing antibodies that were approximately 50-fold higher than baseline at Day 151 post-dose. RSV neutralizing antibody levels remained greater than 19-fold higher than placebo recipients with no known RSV infection through Day 361, suggesting protection may extend beyond Day 151.2 The safety profile across the nirsevimab and placebo groups, as reported in previous trials, remains similar.3-6 These findings contribute to the growing body of evidence suggesting that nirsevimab can protect all infants through their first RSV season with a single dose.1-7 Eric Simoes, MDClinical Professor, Pediatrics-Infectious Diseases, UC Denver School of MedicineRSV remains the most common cause of LRTI in infants and results in seasonal epidemics globally each year. These new analyses strengthen nirsevimabs potential to protect all infants across the RSV season with a single dose, which may lead to a paradigm shift in RSV prevention. Jean-Francois ToussaintGlobal Head of Research and Development Vaccines, Sanofi These new analyses are very consistent with and confirm the strong results observed in all Phase 2 and Phase 3 studies that evaluated nirsevimab in diverse pediatric populations. We take pride in the progress made to develop a potential solution to address this long unmet need for all infants. Mene PangalosExecutive Vice President, BioPharmaceuticals R&D, AstraZeneca Each year, RSV causes seasonal epidemics of LRTIs in infants. These analyses add to nirsevimabs compelling body of evidence as the first potential single-dose preventative immunization for all infants against RSV, addressing a clear unmet need in the RSV preventative landscape. The data are being presented at the 40th Annual Meeting of the European Society for Paediatric Infectious Diseases (ESPID) from May 9-13 in Athens, Greece. Nirsevimab is being developed by Sanofi and AstraZeneca. About nirsevimab Nirsevimab is an investigational long-acting antibody designed to protect all infants from birth entering their first RSV season with a single dose. Due to its extended half-life technology, nirsevimab is being developed as a single dose for protection of all infants through their first RSV season.5,6,8 Nirsevimab is an immunization designed to provide direct RSV protection to all infants via an antibody to help prevent LRTI caused by RSV. Monoclonal antibodies do not require the activation of the immune system to help offer rapid and direct protection against disease.9 In March 2017, Sanofi and AstraZeneca announced an agreement to develop and commercialize nirsevimab. Under the terms of the agreement, AstraZeneca leads all development and manufacturing activities and Sanofi will lead commercialization activities and record revenues. Under the terms of the global agreement, Sanofi made an upfront payment of 120m, has paid a development milestone of 30m and will pay up to a further 465m upon achievement of certain development and sales-related milestones. The two companies share all costs and profits. Revenue from the agreement is reported as Collaboration Revenue in the Companys financial statements. Nirsevimab has been granted regulatory designations to facilitate expedited development by several regulatory agencies around the world. These include Breakthrough Therapy Designation by The China Center for Drug Evaluation under the National Medical Products Administration; Breakthrough Therapy Designation from the US Food and Drug Administration; access granted to the European Medicines Agency (EMA) PRIority MEdicines scheme; Promising Innovative Medicine designation by the UK Medicines and Healthcare products Regulatory Agency; and named a medicine for prioritized development under the Project for Drug Selection to Promote New Drug Development in Pediatrics by the Japan Agency for Medical Research and Development (AMED). The safety and efficacy of nirsevimab is currently being evaluated under an accelerated assessment procedure by the EMA. Nirsevimab has not been approved by any regulatory authority. About the pivotal nirsevimab clinical trials The Phase 2b trial was a randomized, placebo-controlled trial designed to measure the efficacy of nirsevimab against medically attended LRTI through 150 days post-dose. Healthy preterm infants of 2935 weeks gestation were randomized (2:1) to receive a single 50mg intramuscular injection of nirsevimab or placebo. Between November 2016 and December 2017, 1,453 infants were randomized (nirsevimab, n=969; placebo, n=484) at the RSV season start. Research was conducted in both hemispheres, at 164 sites in 23 countries.6 Data was published in the New England Journal of Medicine (NEJM) in July 2020. The dosing regimen was optimized based on further exploration of this data. The subsquent Phase 3 study MELODY applied the optimized dosing regimen.1,5 The Phase 3 MELODY trial was a randomized, placebo-controlled trial conducted across 21 countries designed to determine efficacy of nirsevimab against medically attended LRTI due to RSV confirmed by reverse transcriptase polymerase chain reaction testing through 150 days after dosing, versus placebo, in healthy late preterm and term infants (35 weeks gestational age or greater) entering their first RSV season.5 Infants were randomized (2:1) to receive a single 50mg (in infants weighing <5kg) or 100mg (in infants weighing 5kg) intramuscular injection of nirsevimab or placebo. Between July 2019 and March 2020, 1,490 infants were randomized to either nirsevimab or placebo at the RSV season start.3 Data was published on the primary analysis in NEJM in March 2022. The prespecified pooled analyses of the Phase 3 and the Phase 2b trials looked at infants receiving the optimized dosing regimen (infants <5 kg at dosing and receiving the 50 mg dose from Phase 2b and the infants from Phase 3), and demonstrated an efficacy of 79.5% (95% CI 65.9 to 87.7, P<0.0001) against medically attended LRTI and 77.3% (95% CI 50.3, 89.7, P<0.001) against RSV LRTI hospitalizations. The analysis was based on 2,350 infants of which 1,564 infants were randomized to receive nirsevimab and 786 infants were randomized to receive placebo.1 The results of MELODY, Phase 2/3 MEDLEY and the Phase 2b trials demonstrate that nirsevimab provides protection against RSV in all infants entering their first RSV season with a single dose.1-5This all-infant population includes preterm, healthy late preterm and term infants, as well as infants with specific conditions. These trials form the basis of regulatory submissions that began in 2022. About RSV RSV is the most common cause of lower respiratory tract infections (LRTI), including bronchiolitis and pneumonia in infants.10 It is also a leading cause of hospitalization in all infants, with most hospitalizations for RSV occurring in healthy infants born at term.11-14 Globally, in 2015, there were approximately 30 million cases of acute lower respiratory infections leading to more than three million hospitalizations, and it was estimated that there were 60,000 in-hospital deaths of children younger than five years.15,16 In recent months, there has been a resurgence of RSV following the easing of COVID-19 public health measures.17,18 Globally, in 2017, RSV-related direct medical costsincluding hospital, outpatient and follow-up carewere estimated at 4.82 billion.19 About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Media RelationsSandrine Guendoul|+ 33 6 25 09 14 25 |sandrine.guendoul@sanofi.comSally Bain|+ 1 617 834 6026 |sally.bain@sanofi.comNicolas Obrist|+ 33 6 77 21 27 55 |nicolas.obrist@sanofi.comKate Conway|+ 1508364 4931 |kate.conway@sanofi.com Investor RelationsEva Schaefer-Jansen|+ 33 7 86 80 56 39 |eva.schaefer-jansen@sanofi.comArnaud Delepine|+ 33 6 73 69 36 93 | arnaud.delepine@sanofi.comCorentine Driancourt|+ 33 6 40 56 92 21 | corentine.driancourt@sanofi.comFelix Lauscher|+ 1908612 7239 | felix.lauscher@sanofi.comPriya Nanduri | +1 908 981 5560 |priya.nanduri@sanofi.com Nathalie Pham|+ 33 7 85 93 30 17 | nathalie.pham@sanofi.com Sanofi Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words expects, anticipates, believes, intends, estimates, plans and similar expressions. Although Sanofis management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofis ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. Any material effect of COVID-19 on any of the foregoing could also adversely impact us. This situation is changing rapidly and additional impacts may arise of which we are not currently aware and may exacerbate other previously identified risks. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under Risk Factors and Cautionary Statement Regarding Forward-Looking Statements in Sanofis annual report on Form 20-F for the year ended December 31, 2021. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. References Simoes, E, et al. Pooled efficacy of nirsevimab against RSV lower respiratory tract infection in preterm and term infants. ESPID 2022 Congress; 2022 May 9-13. Hybrid Congress. Wilkins, D, et al. Nirsevimab for the prevention of respiratory syncytial virus infection: neutralizing antibody levels following a single dose. ESPID 2022 Congress; 2022 May 9-13. Hybrid Congress. Hammitt LL, MD et al. Nirsevimab for Prevention of RSV in Healthy Late -Preterm and Term Infants. N Engl J Med. 2022;386 (9): 837-846. doi: 10.1056/NEJMoa2110275.Griffin P, MD et al. (2020). Single-Dose Nirsevimab for Prevention of RSV in Preterm Infants. NEJM 2020; 383: 415-425. DOI: 10.1056/NEJMoa1913556. Clinicaltrials.gov. A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended RSV LRTI in Healthy Late Preterm and Term Infants (MELODY). https://clinicaltrials.gov/ct2/show/NCT03979313. Accessed May 2022.Clinicaltrials.gov. A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended RSV LRTI in Healthy Preterm Infants. (MEDI8897 Ph2b). https://clinicaltrials.gov/ct2/show/results/NCT02878330. Accessed May 2022.Clinicaltrials.gov. A Study to Evaluate the Safety of MEDI8897 for the Prevention of Medically Attended Respiratory Syncytial Virus (RSV) Lower Respiratory Track Infection (LRTI) in High-risk Children. https://clinicaltrials.gov/ct2/show/NCT03959488. Accessed May 2022.Zhu Q, et al. A highly potent extended half-life antibody as a potential RSV vaccine surrogate for all infants. Sci Transl Med. 2017;9:pii: eaaj1928Centers for Disease Control and Prevention. Vaccines & Immunizations. August 18, 2017. https://www.cdc.gov/vaccines/vac-gen/immunity-types.htm. Accessed May 2022.R K. Respiratory Syncytial Virus Vaccines. Plotkin SA, Orenstein WA, Offitt PA, Edwards KM, eds Plotkins Vaccines 7th ed Philadelphia. 2018;7th ed. Philadelphia:943-9.Leader S, Kohlhase K. Respiratory syncytial virus-coded pediatric hospitalizations, 1997 to 1999. The Pediatric infectious disease journal. 2002;21(7):629-32.McLaurin KK, Farr AM, Wade SW, Diakun DR, Stewart DL. Respiratory syncytial virus hospitalization outcomes and costs of full-term and preterm infants. Journal of Perinatology: official journal of the California Perinatal Association. 2016;36(11):990-6.Rha B, et al. Respiratory Syncytial Virus-Associated Hospitalizations Among Young Children: 2015-2016. Pediatrics. 2020;146:e20193611.Arriola CS, et al. Estimated Burden of Community-Onset Respiratory Syncytial Virus-Associated Hospitalizations Among Children Aged <2 Years in the United States, 2014-15. J Pediatric Infect Dis Soc. 2020;9:587-595Shi T, et al. Global, regional, and national disease burden estimates of acute lower respiratory infections due to respiratory syncytial virus in young children in 2015: a systematic review and modelling study. Lancet 2017;390:94658.Oxford Vaccines Group. What is RSV? https://vk.ovg.ox.ac.uk/vk/rsv. Accessed May 2022.Ujiie M, Tsuzuki S, Nakamoto T, et al. Resurgence of Respiratory Syncytial Virus Infections during COVID-19 Pandemic, Tokyo, Japan. Emerging Infectious Diseases. 2021;27(11):2969-2970. doi:10.3201/eid2711.211565.CDC Health Alert Network. Increased Interseasonal Respiratory Syncytial Virus (RSV) Activity in Parts of the Southern United States. Centers for Disease Control and Prevention. June 10 2021. https://emergency.cdc.gov/han/2021/han00443.asp Accessed May 2022.Zhang S, et al. Cost of Respiratory Syncytial Virus-Associated Acute Lower Respiratory Infection Management in Young Children at the Regional and Global Level: A Systematic Review and Meta-Analysis. J Infect Dis. 2020;222(Suppl 7):S680-687. Attachment Source: West Corporation May 04, 2022: Banco Santander Press Release: Foundation S: Sanofis new philanthropic spearhead Foundation S: Sanofis new philanthropic spearhead Paris, May 4, 2022. Sanofi today launches Foundation S The Sanofi Collective, its philanthropic endowment fund aiming to create healthier futures for generations. Using donations, partnerships and collective action, Foundation S will focus on three critical areas: childhoodcancer, the health of communities most vulnerable to the effects of climate change and pollution, and access to lifesaving medicines and vaccines. Serge WeinbergChairman of the Board of Directors, Sanofi and President, Foundation SAs a global healthcare company, we must take part in tackling some of the challenges our society faces. We are proud of what the Sanofi Espoir Foundation has achieved this past decade and the legacy it leaves. The world changes at an incredible pace and numerous new systemic challenges emerge. Now is the right time to go one step further and Foundation S is the right structure, more focused, more agile, to better help vulnerable populations across the world. Foundation S will incorporate as its cornerstone initiative the former Sanofi Espoir Foundations My Child Matters program in childhoodcancer. Launched in 2005 to give every child an equal chance of survival, My Child Matters provides financial support and expertise so that all children can access diagnosis and treatment. The program has helped more than 120,000 children, trained over 50,000 healthcare professionals and been credited with increasing survival outcomes. Additionally, Foundation S will fund awareness and research forchildhood cancer in various countries. Together, these initiatives support the World Health Organization (WHO) objective of achieving at least 60% survival for all children with cancer by 2030, saving an additional 1 million lives over the next decade. Fighting for healthier futures requires addressing todays challenges and anticipating growing crises. To that end, Foundation S will work to increase the health resilience of vulnerable populations most impacted by climate change and pollution. Foundation S will begin by collaborating with the international NGO Friendship, Bangladesh-based, focused on that nations hard-to-reach, climate-vulnerable islands of Gaibandha. There, Foundation S will help train healthcare workers, and fund satellite clinics and a floating hospital in a region outside mainstream healthcare services. To better help vulnerable populations, Foundation S will leverage Sanofis longstanding emergency aid expertise and improve the connection between humanitarian and development financing. As in Ukraine, where the company has coordinated and accelerated donations of essential medicines and vaccines for patients and refugees, Foundation S will renew Sanofis emergency aid donations program and expand proactive support notably for displaced populations. Paul HudsonChief Executive Officer, Sanofi and Board Member, Foundation SThe launch of Foundation S is a new cornerstone of Sanofis commitment to society and a pivotal moment for the life of our company and our people. With Foundation S, we aim to weigh in and act on targeted areas where we know we can make a real difference for populations exposed to health difficulties. Foundation S will operate as a think & do tank. The think-tank guides the development and implementation of Foundation Ss focus areas, convenes thought-provoking discussions on how to best address health challenges. The do-tank is the operational arm that supports program implementation and monitors their impact on public health. Sanofi employees will be key to the success of the Foundation S and be empowered to support its programs and partners through volunteering and preceptorships: a period of practical experience to be gained. Vanina Laurent-Ledru to head Foundation S The Sanofi CollectiveVanina Laurent-Ledru will lead Foundation S. She was previously Head of Global Public Affairs for Sanofi Specialty Care. Before joining Sanofi, Laurent-Ledru worked on public health matters at the global vaccine alliance Gavi, and at other health companies. Vanina Laurent-LedruHead of Foundation SWe cannot change the world on our own intelligence of the heart can only be collective. The launch of Foundation S is the culmination of joint ideas and forces. Collaborating with diverse and multicultural partners and our people, the Sanofi Collective combines our energy and expertise to deepen our impact for communities in need. This endowment fund allows Foundation S to open the opportunity for co-sponsorship of public initiatives and broader partnerships. Through its direct product donation programs and humanitarian efforts, and by working with partners and organizations around the world, Foundation S further strengthens Sanofis longstanding commitment to society. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Media RelationsSandrine Guendoul|+ 33 6 25 09 14 25 |sandrine.guendoul@sanofi.comVictor Rouault|+ 33 6 70 93 71 40 |victor.rouault@sanofi.comEvan Berland | +1 215 432 0234 | evan.berland@sanofi.com Attachment Press Release Source: West Corporation Apr 29, 2022: Banco Santander Press Release: Sanofi continues to deliver strong business EPS growth driven by higher sales and improved margins in Q1 Sanofi continues to deliver strong business EPS(1) growth driven by higher sales and improved margins in Q1 Paris, April 28, 2022 Q1 2022 sales growth of 8.6% at CER driven by Dupixent and CHC Q1 2022 business EPS(1) up 16.1% at CER driven by higher sales and improving margins Progress on Corporate Social Responsibility strategy Key milestone and regulatory achievements on R&D transformation 2022 financial outlook Sanofi Chief Executive Officer, Paul Hudson, commented: We are off to a strong start to 2022 propelled by the continued outstanding performance of Dupixent, double-digit growth of our CHC business and improved margins in the first quarter. In R&D, we increased our investments to fuel our rapidly advancing pipeline which was further enhanced through BD collaborations such as Seagen, IGM, Exscientia and Blackstone during the period. As highlighted at our investor event in March, we remain focused on our path to industry leadership in Immunology with a broad set of novel treatments in development, including additional indications for Dupixent in diseases such as Prurigo Nodularis and Eosinophilic Esophagitis which were recently submitted for regulatory approval. In addition, we are particularly excited about the positive pivotal trial readout for efanesoctogog alfa, our potentially revolutionizing treatment for Hemophilia A patients, with its filing planned for mid-year. Also in the quarter, we continued to execute well against our strategic priorities with our decision for the proposed EUROAPI shares listing and spin-off through an extraordinary dividend. Based on the strong first quarter, we are on track to deliver on our 2022 financial guidance, despite the challenging business environment. Changes in net sales are expressed at constant exchange rates (CER) unless otherwise indicated (definition in Appendix 7) (1) In order to facilitate an understanding of operational performance, Sanofi comments on the business net income statement. Business net income is a non-GAAP financial measure (definition in Appendix 7). The consolidated income statement for Q1 2022 is provided in Appendix 3 and a reconciliation of reported IFRS net income to business net income is set forth in Appendix 4; (2) 2021 business EPS was 6.56; (3) Free cash flow is a non-GAAP financial measure (definition in Appendix 7). 2022 first-quarter Sanofi sales ----------------------------Unless otherwise indicated, all percentage changes in sales in this press release are stated at CER1 ---------------------------- In the first quarter of 2022, Sanofi sales were 9,674 million, up 12.6% on a reported basis. Exchange rate movements had a positive effect of 4.0 percentage points, mainly due to the U.S. dollar. At CER, company sales were up 8.6%. Global Business Units First-quarter 2022 operating income First-quarter business operating income (BOI) increased 16.2% to 3,065 million. At CER, BOI increased 12.2%. The ratio of BOI to net sales increased 1.0 percentage point to 31.7% (31.7% at CER). Pharmaceuticals First-quarter 2022 Pharmaceutical sales increased 7.5% to 7,326 million, mainly driven by the Specialty Care portfolio (up 17.8%) with continued strong performance of Dupixent while sales in General Medicines decreased 0.7%. Specialty Care Dupixent In the first quarter, Dupixent (collaboration with Regeneron) sales increased 45.7% to 1,614 million. In the U.S., Dupixent sales of 1,176 million (up 38.1%) were driven by continued strong demand in AD in adults, adolescents, and children aged 6 to 11 years, and continued uptake in asthma and chronic rhinosinusitis with nasal polyposis (CRSwNP). Dupixent total prescriptions (TRx) increased 43% (year-over-year) and new-to-brand prescriptions (NBRx) grew 32%. In Europe, first-quarter Dupixent sales grew 53.3% to 211 million reflecting continued growth in AD and additional launches in younger population in AD, asthma and CRSwNP. Neurology and Immunology Source: West Corporation Apr 28, 2022: Banco Santander Press Release: Sanofi continues to deliver strong business EPS growth driven by higher sales and improved margins in Q1 Sanofi continues to deliver strong business EPS(1) growth driven by higher sales and improved margins in Q1 Paris, April 28, 2022 Q1 2022 sales growth of 8.6% at CER driven by Dupixent and CHC Q1 2022 business EPS(1) up 16.1% at CER driven by higher sales and improving margins Progress on Corporate Social Responsibility strategy Key milestone and regulatory achievements on R&D transformation 2022 financial outlook Sanofi Chief Executive Officer, Paul Hudson, commented: We are off to a strong start to 2022 propelled by the continued outstanding performance of Dupixent, double-digit growth of our CHC business and improved margins in the first quarter. In R&D, we increased our investments to fuel our rapidly advancing pipeline which was further enhanced through BD collaborations such as Seagen, IGM, Exscientia and Blackstone during the period. As highlighted at our investor event in March, we remain focused on our path to industry leadership in Immunology with a broad set of novel treatments in development, including additional indications for Dupixent in diseases such as Prurigo Nodularis and Eosinophilic Esophagitis which were recently submitted for regulatory approval. In addition, we are particularly excited about the positive pivotal trial readout for efanesoctogog alfa, our potentially revolutionizing treatment for Hemophilia A patients, with its filing planned for mid-year. Also in the quarter, we continued to execute well against our strategic priorities with our decision for the proposed EUROAPI shares listing and spin-off through an extraordinary dividend. Based on the strong first quarter, we are on track to deliver on our 2022 financial guidance, despite the challenging business environment. Changes in net sales are expressed at constant exchange rates (CER) unless otherwise indicated (definition in Appendix 7) (1) In order to facilitate an understanding of operational performance, Sanofi comments on the business net income statement. Business net income is a non-GAAP financial measure (definition in Appendix 7). The consolidated income statement for Q1 2022 is provided in Appendix 3 and a reconciliation of reported IFRS net income to business net income is set forth in Appendix 4; (2) 2021 business EPS was 6.56; (3) Free cash flow is a non-GAAP financial measure (definition in Appendix 7). 2022 first-quarter Sanofi sales ----------------------------Unless otherwise indicated, all percentage changes in sales in this press release are stated at CER1 ---------------------------- In the first quarter of 2022, Sanofi sales were 9,674 million, up 12.6% on a reported basis. Exchange rate movements had a positive effect of 4.0 percentage points, mainly due to the U.S. dollar. At CER, company sales were up 8.6%. Global Business Units First-quarter 2022 net sales by Global Business Unit (variation at CER; million; % of total sales) First-quarter 2022 net sales by geographic region (variation at CER; million; % of total sales) First-quarter 2022 operating income First-quarter business operating income (BOI) increased 16.2% to 3,065 million. At CER, BOI increased 12.2%. The ratio of BOI to net sales increased 1.0 percentage point to 31.7% (31.7% at CER). Pharmaceuticals First-quarter 2022 Pharmaceutical sales increased 7.5% to 7,326 million, mainly driven by the Specialty Care portfolio (up 17.8%) with continued strong performance of Dupixent while sales in General Medicines decreased 0.7%. Specialty Care Dupixent In the first quarter, Dupixent (collaboration with Regeneron) sales increased 45.7% to 1,614 million. In the U.S., Dupixent sales of 1,176 million (up 38.1%) were driven by continued strong demand in AD in adults, adolescents, and children aged 6 to 11 years, and continued uptake in asthma and chronic rhinosinusitis with nasal polyposis (CRSwNP). Dupixent total prescriptions (TRx) increased 43% (year-over-year) and new-to-brand prescriptions (NBRx) grew 32%. In Europe, first-quarter Dupixent sales grew 53.3% to 211 million reflecting continued growth in AD and additional launches in younger population in AD, asthma and CRSwNP. Neurology and Immunology Source: West Corporation Apr 26, 2022: Banco Santander Press Release: Sanofi teams up with McLaren Racing to accelerate industrial excellence Sanofi teams up with McLaren Racing to accelerate industrial excellence Paris, April 26. Sanofi announces today that it is partnering with McLaren Racing to accelerate manufacturing efficiency and performance in support of the companys ambition to attain world-class standards of manufacturing excellence. Following a successful pilot in 2021 with McLaren Racing, both companies have decided to extend their collaboration across multiple sites in seven countries, covering more than 100 production lines, across all technologies. Learnings from this partnership will provide insights and develop best practices for manufacturing that will then be implemented across Sanofis global industrial network . Paul HudsonChief Executive OfficerWe are thrilled to partner with McLaren and learn from their winning spirit and culture of going over and above. I see a lot of commonalities in our shared values to stretch, with courage and determination, so we can maximize performance and operational excellence. We want to run our lines with the speed, precision and efficiency of an F1 racing team. McLaren Racing experts will collaborate with Sanofis Industrial Affairs team to enable continued optimization of its manufacturing operations, enabling its global network to better support the supply of its broad portfolio, as well as enhancing the delivery of its R&D pipeline, with 25 new launches expected in the next five years to meet patients needs around the world. With a unique data-driven approach, McLaren Racing will bring its digital and analytical expertise and skills to further elevate Sanofis performance by helping to better anticipate and resolve issues before they take place. Modelling simulation of production line changeovers and operations will be key areas of McLarens Formula 1 experience, as exemplified using advanced data analytics and expertise used to optimize the famed pit stops of F1 races. Zak BrownChief Executive Officer, McLaren RacingWe are thrilled to be partnering with Sanofi. It is important that two global companies who share values work together to maximise performance. We look forward to continuing to collaborate with Sanofi to make a positive impact not only in manufacturing but to help Sanofi improve patients' lives. Beyond the technical leadership from F1, the collaboration will bring a specific focus on the people dimension of high performance. The partnership will bring a race-like mindset, emulating the competitive, fast paced environment of F1 racing to help accelerate improvements, learnings and sharing of best practices individually and collectively across sites, fostering a one Sanofi spirit. This unique opportunity will marry the best of the two companies with the speed, agility, teamwork, and constant improvement required to succeed in motor racing, as well as in healthcare discoveries. Brendan OCallaghanExecutive Vice President for Industrial Affairs, SanofiWe aspire to industry-leading capability across our global network of sites, so we can deliver on our mission to translate the miracles of science - discovered in our laboratories - into reality for patients. This program represents a great opportunity to improve our manufacturing sites' performance with a leading partner like McLaren, who personifies high performance in a fast-paced, ultra-competitive environment, leveraging advanced data driven analytics and precision engineering to gain a winning edge. Accelerating our performance in this way will help us further expand the reach of our medicines to even more patients around the world. About McLaren RacingMcLaren Racing was founded by New Zealand racing driver Bruce McLaren in 1963. The team entered its first Formula 1 race in 1966, since then McLaren has won 20 Formula 1 world championships, more than 180 Formula 1 grands prix, the Indianapolis 500 three times, and the Le Mans 24 Hours at its first attempt. The team competes in the FIA Formula 1 World Championship with Lando Norris and Daniel Ricciardo, the NTT INDYCAR Series with Arrow McLaren SP drivers Pato OWard and Felix Rosenqvist, and the Extreme E Championship with Emma Gilmour and Tanner Foust.McLaren was the first F1 team to be awarded the Carbon Trust Standard in 2010 and has retained it since on a bi-annual basis, most recently in February 2021. The team was also the first in F1 to be given the FIA Sustainability Accreditation Award at a three-star level in 2013 as part of the FIA Environmental Certification framework, before becoming a signatory to the UN Sports for Climate Action Commitment in 2021. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Media RelationsSandrine Guendoul|+ 33 6 25 09 14 25 |sandrine.guendoul@sanofi.comNicolas Obrist|+ 33 6 77 21 27 55 |nicolas.obrist@sanofi.com Investor RelationsEva Schaefer-Jansen|+ 33 7 86 80 56 39 |eva.schaefer-jansen@sanofi.comFelix Lauscher|+ 1908612 7239 | felix.lauscher@sanofi.com Sanofi Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words expects, anticipates, believes, intends, estimates, plans and similar expressions. Although Sanofis management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofis ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. Any material effect of COVID-19 on any of the foregoing could also adversely impact us. This situation is changing rapidly and additional impacts may arise of which we are not currently aware and may exacerbate other previously identified risks. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under Risk Factors and Cautionary Statement Regarding Forward-Looking Statements in Sanofis annual report on Form 20-F for the year ended December 31, 2021. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. Attachment Press Release Source: West Corporation Apr 14, 2022: Banco Santander Press Release: Positive Phase 1/2 study results of rilzabrutinib in people with immune thrombocytopenia published in The New England Journal of Medicine Positive Phase 1/2 study results of rilzabrutinib in people with immune thrombocytopenia published in The New England Journal of Medicine Results published today in the New England Journal of Medicine showed that treatment with rilzabrutinib resulted in a rapid and durable increase in platelet count in patients with heavily pretreated immune thrombocytopenia (ITP)Data support an acceptable safety profileRilzabrutinib is an investigational oral Bruton tyrosine kinase inhibitor (BTKi) for the treatment of ITP, a rare acquired autoimmune disorder in which platelets are destroyed or damaged and for which there are limited treatment options PARIS April 14, 2022 - Positive results from the Phase 1/2 dose-finding study evaluating the safety, pharmacokinetics and clinical activity of rilzabrutinib, an investigational oral Brutons tyrosine kinase (BTK) inhibitor, in adults with heavily pre-treated immune thrombocytopenia (ITP) were published in the New England Journal of Medicine. Results demonstrate treatment with rilzabrutinib led to a rapid and durable increase in platelet count and support an acceptable safety profile. Sanofi is investigating the safety and efficacy of twice daily rilzabrutinib (400 mg) for adults and adolescents with chronic ITP in the ongoing Phase 3 clinical study LUNA 3, initiated in April 2021. David Kuter, M.D.Director of clinical hematology at Massachusetts General Hospital and professor of medicine at Harvard Medical School, lead author of the study Currently, there are no standard treatment recommendations for ITP patients with multiple relapses. Despite advances in treatment options over the years, some patients remain refractory to existing therapies and durable remission remains elusive. The Brutons tyrosine kinase is a critical signaling molecule in the immune system that is involved in certain immune-mediated diseases, and our research suggests that targeting BTK may represent a promising approach to addressing the underlying cause of ITP. ITP is an acquired autoimmune blood disorder characterized by low platelet count (thrombocytopenia) resulting from immune-mediated platelet destruction and impairment of platelet production. A decrease in platelet counts whether temporary or persistent can predispose a person to a higher risk of bleeding, hospitalization, fatigue, impaired quality of life, and even death. The incidence of ITP increases with age and is more common over the age of 60. Dietmar Berger, M.D., Ph.D.Global Head of Clinical Development and Chief Medical Officer, Sanofi We are pleased to share these encouraging early clinical results through this publication.These findings demonstrate a clinically meaningful response in difficult-to-treat ITP patients who received a median of four prior ITP therapies. Moreover, the overall study population, which also included less refractory patients, showed a numerically higher response. Rilzabrutinib could become a first-in-class BTK inhibitor therapy with the potential to increase platelet counts quickly and durably for people with ITP. Rilzabrutinib was granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) for treatment of ITP in November of 2020 and was previously granted orphan drug designation. Rilzabrutinib is being investigated in multiple clinical trials across a range of diseases including immunological and inflammatory diseases. Phase 1/2 Study Results The global Phase 1/2 adaptive, open-label, dose-finding study evaluated rilzabrutinib in 60 people with ITP with a median age of 50 years (range, 19-74). Patients had received a median of four different ITP therapies previously. Initial doses could be 200 mg once daily, 400 mg once daily, 300 mg twice daily (600 mg/day), or 400 mg twice daily (800 mg/day). The median platelet counts at the start of the study were 15109/L, indicating a very low platelet count and high risk of bleeding. The primary endpoint measured the number of participants who achieved at least two consecutive platelet counts of 50109/L and an overall platelet count increase of 20109/L from the start of treatment without requiring rescue medication. Study results showed: Overall, 24 of 60 people enrolled in the study at any dose achieved the primary endpoint. Of the 45 people who initiated rilzabrutinib at 400 mg twice daily, 18 met the primary endpoint.Median time to first platelet count of at least 50109/L was rapid at 11.5 days, which was maintained in patients with primary platelet response for a mean of 65% of weeks during the 24-week treatment period.52% of participants experienced at least one treatment related adverse event, all of which were grade 1 or 2; the most common adverse events were diarrhea (32%), nausea (30%), and fatigue (10%). There were no grade 3 or higher treatment-related adverse events or serious adverse events. Rilzabrutinib Clinical ProgramThe safety and efficacy of rilzabrutinib in ITP are being evaluated in the ongoing randomized, double-blind, Phase 3 LUNA 3 study in adults and adolescents (aged 12 years) with persistent/chronic ITP. In addition, phase 2 studies are ongoing to evaluate rilzabrutinib as a potential therapy for the autoimmune condition IgG4 disease and immunological diseases, including asthma, atopic dermatitis, chronic spontaneous urticaria and warm autoimmune hemolytic anemia. About RilzabrutinibRilzabrutinib is an oral Brutons tyrosine kinase inhibitor incorporating Sanofis TAILORED COVALENCY technology being investigated for the treatment of immune-mediated diseases, including ITP. BTK is an intracellular signaling molecule involved in innate and adaptive immune responses related to certain immune-mediated diseases. By inhibiting BTK, rilzabrutinib has the potential to target the underlying disease pathogenesis. Rilzabrutinib is currently under clinical investigation and its safety and efficacy have not been evaluated by any regulatory authority. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Media RelationsSally Bain|+ 1 617 834 6026 |sally.bain@sanofi.com Investor RelationsEva Schaefer-Jansen|+ 33 7 86 80 56 39 |eva.schaefer-jansen@sanofi.comArnaud Delepine|+ 33 6 73 69 36 93 | arnaud.delepine@sanofi.comCorentine Driancourt|+ 33 6 40 56 92 21 | corentine.driancourt@sanofi.comFelix Lauscher|+ 1908612 7239 | felix.lauscher@sanofi.comPriya Nanduri|+1 908 981 5560 | priya.nanduri@sanofi.com Nathalie Pham|+ 33 7 85 93 30 17 | nathalie.pham@sanofi.com Sanofi Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words expects, anticipates, believes, intends, estimates, plans and similar expressions. Although Sanofis management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofis ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. Any material effect of COVID-19 on any of the foregoing could also adversely impact us. This situation is changing rapidly and additional impacts may arise of which we are not currently aware and may exacerbate other previously identified risks. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under Risk Factors and Cautionary Statement Regarding Forward-Looking Statements in Sanofis annual report on Form 20-F for the year ended December 31, 2021. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. Attachment Source: West Corporation Apr 07, 2022: Banco Santander Press Release: Dupixent (dupilumab) approved by European Commission for children aged 6 to 11 years with severe asthma with type 2 inflammation Dupixent (dupilumab) approved by European Commission for children aged 6 to 11 years with severe asthma with type 2 inflammation Dupixent is the only biologic indicated in the European Union for severe asthma with type 2 inflammation, characterized by raised blood eosinophils and/or raised fractional exhaled nitric oxide Approval based on Phase 3 data showing Dupixent significantly reduced severe asthma attacks and also improved lung function and health-related quality of life for childrenData reinforce well-established safety profile of Dupixent Paris and Tarrytown, N.Y. April 7, 2022. The European Commission (EC) has expanded the marketing authorization for Dupixent (dupilumab) in the European Union. Dupixent is now also approved in children aged 6 to 11 years as an add-on maintenance treatment for severe asthma with type 2 inflammation characterized by raised blood eosinophils and/or raised fractional exhaled nitric oxide (FeNO), who are inadequately controlled with medium to high dose inhaled corticosteroids (ICS) plus another medicinal product for maintenance treatment. Naimish Patel, M.D.Head of Global Development, Immunology and Inflammation, SanofiWe are excited to bring the well-established safety and efficacy of Dupixent to even younger patients living with uncontrolled severe asthma in Europe. In addition to greatly reducing severe asthma attacks and improving lung function, patients in our clinical trial also reduced their oral corticosteroid use. This is particularly meaningful as these are medicines that can carry significant safety risks if used long term. This approval underscores our continued commitment to bringing Dupixent to as many patients as possible suffering from the negative effects of severe asthma with the hope of improving their quality of life. Asthma is one of the most common chronic diseases in children. Up to 85% of children with asthma may have type 2 inflammation and are more likely to have higher disease burden. Despite treatment with current standard-of-care ICS and bronchodilators, these children may continue to experience serious symptoms such as coughing, wheezing and difficulty breathing. Severe asthma may impact children's developing airways and cause potentially life-threatening exacerbations. Children with severe asthma also may require the use of multiple courses of systemic corticosteroids that carry significant risks. Uncontrolled severe asthma can interfere with day-to-day activities, like sleeping, attending school and playing sports. Dupixent is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not an immunosuppressant. The Dupixent Phase 3 clinical program, which has shown significant clinical benefit and a decrease in type 2 inflammation, has established that IL-4 and IL-13 are key and central drivers of the type 2 inflammation that plays a major role in in multiple related and often co-morbid diseases. George D. Yancopoulos, M.D., Ph.D.President and Chief Scientific Officer, RegeneronTodays approval in Europe recognizes the benefits of Dupixent in helping children living with the profound effects of severe asthma, including unpredictable asthma attacks, routine disruption to daily activities and the use of systemic steroids that can impede childrens growth. Dupixent is the only treatment available that specifically blocks two key drivers of type 2 inflammation, IL-4 and IL-13, which our trials show plays a major role in childhood asthma, as well as in related conditions such as chronic rhinosinusitis with nasal polyposis and the often co-morbid condition, atopic dermatitis. In clinical trials, Dupixent significantly reduced asthma attacks, helped children breathe better and improved their health-related quality of life. We also remain committed to investigating Dupixent in other conditions where type 2 inflammation may significantly impact patients lives, including eosinophilic esophagitis, prurigo nodularis and chronic spontaneous urticaria. The EC decision is based on pivotal data from the Phase 3 VOYAGE trial evaluating the efficacy and safety of Dupixent combined with standard-of-care asthma therapy in 408 children with uncontrolled moderate-to-severe asthma. Two pre-specified populations with evidence of type 2 inflammation were evaluated for the primary analysis: 1) patients with baseline blood eosinophils (EOS) 300 cells/l (n=259) and 2) patients with either baseline FeNO 20 parts per billion (ppb) or baseline blood EOS 150 cells/l (n=350). Patients who added Dupixent to standard-of-care in these two groups, respectively, experienced: Substantially reduced rates of severe asthma attacks, with a 65% and 59% average reduction over one year compared to placebo (0.24 and 0.31 events per year for Dupixent vs. 0.67 and 0.75 for placebo, respectively).Improved lung function observed as early as two weeks and sustained for up to 52 weeks, measured by percent predicted FEV1 (FEV1pp). At 12 weeks, patients taking Dupixent improved their lung function by 5.32 and 5.21 percentage points compared to placebo, respectively. Improved asthma control, with 81% and 79% of patients reporting a clinically meaningful improvement at 24 weeks, based on disease symptoms and impact compared to 64% and 69% of placebo patients, respectively.Improved health-related quality of life, with 73% and 73% of patients reporting a clinically meaningful improvement at 24 weeks, compared to 63% and 65% of placebo patients, respectively.Reduced systemic corticosteroid use by an average of 66% and 59% over one year compared to placebo (0.27 and 0.35 courses per year for Dupixent vs. 0.81 and 0.86 for placebo, respectively). The safety results from the trial were generally consistent with the known safety profile of Dupixent in patients aged 12 years and older with uncontrolled moderate-to-severe asthma. The overall rates of adverse events were 83% for Dupixent and 80% for placebo. Adverse events that were more commonly observed with Dupixent compared to placebo included injection site reactions (18% Dupixent, 13% placebo), viral upper respiratory tract infections (12% Dupixent, 10% placebo) and eosinophilia (7% Dupixent, 1% placebo). Helminth infections were also more commonly observed with Dupixent in patients aged 6 to 11 years and were reported in 2% of Dupixent patients and 0% of placebo patients. About the LIBERTY ASTHMA VOYAGE Trial The Phase 3 randomized, double-blind, placebo-controlled trial evaluated the efficacy and safety of Dupixent (100 mg or 200 mg every two weeks, based on weight tier) combined with standard-of-care asthma therapy in 408 children aged 6 to 11 years with uncontrolled moderate-to-severe asthma. More than 90% of children in the trial had at least one concurrent atopic medical condition such as allergic rhinitis and atopic dermatitis. The primary endpoint was the annualized rate of severe asthma exacerbations over one year, and the key secondary endpoint was the change from baseline in percentage of predicted pre-bronchodilator FEV1 (FEV1pp) at week 12. The FEV1pp seeks to evaluate a patient's change in lung function compared to their predicted lung function based on age, height, sex and ethnicity to account for children's growing lung capacity at different stages of development. Additional secondary endpoints included responder rates for asthma control as measured by a 0.5 improvement on the Asthma Control Questionnaire-7 Interviewer Administered (ACQ-7-IA; 7-point scale) and health-related quality of life as measured by a 0.5 improvement on the Pediatric Asthma Quality of Life Questionnaire with Standardized Activities-Interviewer Administered (PAQLQ(S)-IA; 7-point scale). About Dupixent Dupixent is also approved in Europe, U.S., Japan and other countries around the world for use in certain patients with asthma, specific patients with moderate-to-severe atopic dermatitis as well as CRSwNP in different age populations. Dupixent is also approved in one or more of these indications in more than 60 countries around the world, and more than 400,000 patients have been treated globally. Dupixent is an injection under the skin (subcutaneous injection) at different injection sites. In the EU for pediatric patients aged 6 to 11 years, Dupixent dosing is based on weight tier (100 mg every two weeks or 300 mg every four weeks for children 15 to <30 kg, 200 mg every two weeks or 300 mg every four weeks for children 30 to <60 kg and 200 mg every two weeks for children 60 kg) and is supplied as a pre-filled syringe. It is also available as a pre-filled pen for adolescents (12 to 17 years) and adults at 200 and 300 mg doses. Dupixent is intended for use under the guidance of a healthcare professional and can be given in a clinic or at home by self-administration after training by a healthcare professional. In children younger than 12 years of age, Dupixent should be administered by a caregiver if given at home. Dupilumab Development Program Dupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement. To date, dupilumab has been studied across more than 60 clinical trials involving more than 10,000 patients with various chronic diseases driven in part by type 2 inflammation. In addition to the currently approved indications, Sanofi and Regeneron are studying dupilumab in a broad range of diseases driven by type 2 inflammation or other allergic processes including pediatric atopic dermatitis (6 months to 5 years of age, Phase 3), chronic obstructive pulmonary disease with evidence of type 2 inflammation (Phase 3), eosinophilic esophagitis (Phase 3), bullous pemphigoid (Phase 3), prurigo nodularis (Phase 3), chronic spontaneous urticaria (Phase 3), chronic inducible urticaria-cold (Phase 3), chronic rhinosinusitis without nasal polyposis (Phase 3), allergic fungal rhinosinusitis (Phase 3), allergic bronchopulmonary aspergillosis (Phase 3) and peanut allergy (Phase 2). These potential uses of dupilumab are currently under clinical investigation, and the safety and efficacy in these conditions have not been fully evaluated by any regulatory authority. About Regeneron Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for nearly 35 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, hematologic conditions, infectious diseases and rare diseases. Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite technologies, such as VelocImmune, which uses unique genetically humanized mice to produce optimized fully human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world. For additional information about the company, please visit www.regeneron.com or follow @Regeneron on Twitter. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Sanofi Media RelationsSally Bain|+ 1 617 834 6026 |sally.bain@sanofi.com Sanofi Investor RelationsEva Schaefer-Jansen | + 33 7 86 80 56 39 | eva.schaefer-jansen@sanofi.comArnaud Delepine | + 33 06 73 69 36 93 | arnaud.delepine@sanofi.comCorentine Driancourt | + 33 06 40 56 92 | corentine.driancourt@sanofi.comFelix Lauscher | + 1 908 612 7239 | felix.lauscher@sanofi.comPriya Nanduri | priya.nanduri@sanofi.comNathalie Pham | + 33 07 85 93 30 17 | nathalie.pham@sanofi.com Regeneron Media RelationsAshleigh Dixon | + 1 914 374 2422 | ashleigh.dixon@regeneron.com Regeneron Investor RelationsVesna Tosic | + 914 847 5443 | vesna.tosic@regeneron.com Sanofi Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements are generally identified by the words expects, anticipates, believes, intends, estimates, plans and similar expressions. Although Sanofis management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. Any material effect of COVID-19 on any of the foregoing could also adversely impact us. This situation is changing rapidly and additional impacts may arise of which we are not currently aware and may exacerbate other previously identified risks. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under Risk Factors and Cautionary Statement Regarding Forward-Looking Statements in Sanofis annual report on Form 20-F for the year ended December 31, 2021. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. Regeneron Forward-Looking Statements and Use of Digital Media This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. (Regeneron or the Company), and actual events or results may differ materially from these forward-looking statements. Words such as anticipate, expect, intend, plan, believe, seek, estimate, variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the impact of SARS-CoV-2 (the virus that has caused the COVID-19 pandemic) on Regenerons business and its employees, collaborators, and suppliers and other third parties on which Regeneron relies, Regenerons and its collaborators ability to continue to conduct research and clinical programs, Regenerons ability to manage its supply chain, net product sales of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, Regenerons Products), and the global economy; the nature, timing, and possible success and therapeutic applications of Regenerons Products and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, Regenerons Product Candidates) and research and clinical programs now underway or planned, including without limitation Dupixent (dupilumab) as an add-on maintenance treatment for children aged 6 to 11 years with severe asthma with type 2 inflammation; uncertainty of the utilization, market acceptance, and commercial success of Regenerons Products (such as Dupixent) and Regenerons Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary), including the studies discussed or referenced in this press release, on any of the foregoing or any potential regulatory approval of Regenerons Products (such as Dupixent) and Regenerons Product Candidates; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regenerons Product Candidates and new indications for Regenerons Products, such as Dupixent for the treatment of pediatric atopic dermatitis, chronic obstructive pulmonary disease with evidence of type 2 inflammation, eosinophilic esophagitis, bullous pemphigoid, prurigo nodularis, chronic spontaneous urticaria, chronic inducible urticaria-cold, chronic rhinosinusitis without nasal polyposis, allergic fungal rhinosinusitis, allergic bronchopulmonary aspergillosis, peanut allergy, and other potential indications; the ability of Regenerons collaborators, licensees, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regenerons Products and Regenerons Product Candidates; the ability of Regeneron to manage supply chains for multiple products and product candidates; safety issues resulting from the administration of Regenerons Products (such as Dupixent) and Regenerons Product Candidates in patients, including serious complications or side effects in connection with the use of Regenerons Products and Regenerons Product Candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict Regenerons ability to continue to develop or commercialize Regenerons Products and Regenerons Product Candidates, including without limitation Dupixent; ongoing regulatory obligations and oversight impacting Regenerons Products, research and clinical programs, and business, including those relating to patient privacy; the availability and extent of reimbursement of Regenerons Products from third-party payers, including private payer healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payers and new policies and procedures adopted by such payers; competing drugs and product candidates that may be superior to, or more cost effective than, Regenerons Products and Regenerons Product Candidates; the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators or licensees may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license, collaboration, or supply agreement, including Regenerons agreements with Sanofi, Bayer, and Teva Pharmaceutical Industries Ltd. (or their respective affiliated companies, as applicable) to be cancelled or terminated; and risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA (aflibercept) Injection, Dupixent, Praluent (alirocumab), and REGEN-COV (casirivimab and imdevimab)), other litigation and other proceedings and government investigations relating to the Company and/or its operations, the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regenerons business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regenerons filings with the U.S. Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2021. Any forward-looking statements are made based on managements current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise.Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regenerons media and investor relations website (http://newsroom.regeneron.com) and its Twitter feed (http://twitter.com/regeneron). Attachment Source: West Corporation Apr 04, 2022: Banco Santander Press Release: FDA accepts Dupixent (dupilumab) for Priority Review in patients aged 12 years and older with eosinophilic esophagitis FDA accepts Dupixent (dupilumab) for Priority Review in patients aged 12 years and older with eosinophilic esophagitis If approved, Dupixent would be the first medicine available in the U.S. indicated to treat eosinophilic esophagitisThere are approximately 160,000 patients in the U.S. living with eosinophilic esophagitis who are currently treated, of whom approximately 48,000 have failed multiple treatments Paris and Tarrytown, N.Y., April 4, 2022. The U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent (dupilumab) 300 mg weekly to treat adult and pediatric patients aged 12 years and older with eosinophilic esophagitis (EoE), a chronic and progressive type 2 inflammatory disease that damages the esophagus and impairs the ability to swallow. The target action date for the FDA decision on this investigational use is August 3, 2022. The sBLA is supported by data from two Phase 3 trials evaluating the efficacy and safety of Dupixent 300 mg weekly in patients aged 12 years and older with EoE (Part A and Part B), and data from an active long-term extension trial. Dupixent 300 mg weekly significantly improved the signs and symptoms of EoE at 24 weeks compared to placebo, including the ability to swallow and reduction in eosinophil count in the esophagus. The safety results of these trials were generally consistent with the known safety profile of Dupixent in its approved indications. The most common adverse event observed with Dupixent, in Part A and Part B, was injection site reactions. In September 2020, the U.S. FDA granted Breakthrough Therapy designation to Dupixent for the treatment of patients aged 12 years and older with EoE. Dupixent was also granted Orphan Drug designation for the potential treatment of EoE in 2017. Priority review is granted to therapies that have the potential to provide significant improvements in the treatment, diagnosis or prevention of serious conditions. Regulatory filings around the world are also planned in 2022. The potential use of Dupixent in EoE is currently under clinical development, and the safety and efficacy have not been fully evaluated by any regulatory authority. About Eosinophilic Esophagitis (EoE) EoE is a chronic, progressive type 2 inflammatory disease that damages the esophagus and prevents it from working properly. For people with EoE, swallowing the smallest amount of food can be a painful and worrisome choking experience. Those with EoE live with anxiety and frustration from having a constantly evolving list of foods to avoid. This disease can also cause narrowing of the esophagus and dilation (physical expansion) of the esophagus may be needed, which is often painful. In severe cases, a feeding tube is the only option to ensure proper caloric intake and adequate nutrition. People with EoE may have poor quality of life and are more likely to experience depression than people without EoE. There are approximately 160,000 patients in the U.S. living with EoE who are currently treated, of whom approximately 48,000 have failed multiple treatments. About Dupixent Dupixent is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not an immunosuppressant. IL-4 and IL-13 are key and central drivers of the type 2 inflammation that plays a major role in atopic dermatitis, asthma and chronic rhinosinusitis with nasal polyposis (CRSwNP). In the U.S., Dupixent is approved in patients aged 6 years and older with uncontrolled moderate-to-severe atopic dermatitis; as an add-on maintenance treatment of patients aged 6 years and older with moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid-dependent asthma; and for use with other medicines for the maintenance treatment of chronic rhinosinusitis with nasal polyposis (CRSwNP) in adults whose disease is not controlled. Dupixent is also approved in Europe, Japan and other countries around the world for use in specific patients with moderate-to-severe atopic dermatitis and certain patients with asthma or CRSwNP in different age populations. Dupixent is approved in one or more of these indications in more than 60 countries around the world, and more than 400,000 patients have been treated globally. Dupilumab Development Program Dupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement. To date, dupilumab has been studied across more than 60 clinical trials involving more than 10,000 patients with various chronic diseases driven in part by type 2 inflammation. In addition to the currently approved indications, Sanofi and Regeneron are studying dupilumab in a broad range of diseases driven by type 2 inflammation or other allergic processes, including eosinophilic esophagitis (Phase 3), pediatric atopic dermatitis (6 months to 5 years of age, Phase 3), chronic rhinosinusitis without nasal polyposis (Phase 3), chronic obstructive pulmonary disease with evidence of type 2 inflammation (Phase 3), prurigo nodularis (Phase 3), chronic spontaneous urticaria (Phase 3), bullous pemphigoid (Phase 3), chronic inducible urticaria-cold (Phase 3), allergic fungal rhinosinusitis (Phase 3), allergic bronchopulmonary aspergillosis (Phase 3) and peanut allergy (Phase 2). These potential uses of dupilumab are currently under clinical investigation, and the safety and efficacy in these conditions have not been fully evaluated by any regulatory authority. About Regeneron Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for nearly 35 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, hematologic conditions, infectious diseases and rare diseases. Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite technologies, such as VelocImmune, which uses unique genetically humanized mice to produce optimized fully human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world. For additional information about the company, please visit www.regeneron.com or follow @Regeneron on Twitter. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Sanofi Media RelationsSally Bain | + 1 617 834 6026 | sally.bain@sanofi.com Sanofi Investor RelationsEva Schaefer-Jansen | + 33 7 86 80 56 39 | eva.schaefer-jansen@sanofi.com Arnaud Delepine | + 33 06 73 69 36 93 | arnaud.delepine@sanofi.com Corentine Driancourt | + 33 06 40 56 92 | corentine.driancourt@sanofi.com Felix Lauscher | + 1 908 612 7239 | felix.lauscher@sanofi.com Priya Nanduri | priya.nanduri@sanofi.com Nathalie Pham | + 33 07 85 93 30 17 | nathalie.pham@sanofi.com Regeneron Media RelationsAshleigh Dixon | + 1 914 374 2422 | ashleigh.dixon@regeneron.com Regeneron Investor RelationsVesna Tosic | + 914 847 5443 | vesna.tosic@regeneron.com Sanofi Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements are generally identified by the words expects, anticipates, believes, intends, estimates, plans and similar expressions. Although Sanofis management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. Any material effect of COVID-19 on any of the foregoing could also adversely impact us. This situation is changing rapidly and additional impacts may arise of which we are not currently aware and may exacerbate other previously identified risks. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under Risk Factors and Cautionary Statement Regarding Forward-Looking Statements in Sanofis annual report on Form 20-F for the year ended December 31, 2021. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. Regeneron Forward-Looking Statements and Use of Digital Media This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. (Regeneron or the Company), and actual events or results may differ materially from these forward-looking statements. Words such as anticipate, expect, intend, plan, believe, seek, estimate, variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the impact of SARS-CoV-2 (the virus that has caused the COVID-19 pandemic) on Regenerons business and its employees, collaborators, and suppliers and other third parties on which Regeneron relies, Regenerons and its collaborators ability to continue to conduct research and clinical programs, Regenerons ability to manage its supply chain, net product sales of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, Regenerons Products), and the global economy; the nature, timing, and possible success and therapeutic applications of Regenerons Products and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, Regenerons Product Candidates) and research and clinical programs now underway or planned, including without limitation Dupixent (dupilumab) for the treatment of eosinophilic esophagitis; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regenerons Product Candidates and new indications for Regenerons Products, such as Dupixent for the treatment of eosinophilic esophagitis (including potential approval by the U.S. Food and Drug Administration based on the supplemental Biologics License Application discussed in this press release), chronic obstructive pulmonary disease with evidence of type 2 inflammation, pediatric atopic dermatitis, bullous pemphigoid, prurigo nodularis, chronic spontaneous urticaria, chronic inducible urticaria-cold, chronic rhinosinusitis without nasal polyposis, allergic fungal rhinosinusitis, allergic bronchopulmonary aspergillosis, peanut allergy, and other potential indications; uncertainty of the utilization, market acceptance, and commercial success of Regenerons Products (such as Dupixent) and Regenerons Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary), including the studies discussed or referenced in this press release, on any of the foregoing or any potential regulatory approval of Regenerons Products (such as Dupixent) and Regenerons Product Candidates; the ability of Regenerons collaborators, licensees, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regenerons Products and Regenerons Product Candidates; the ability of Regeneron to manage supply chains for multiple products and product candidates; safety issues resulting from the administration of Regenerons Products (such as Dupixent) and Regenerons Product Candidates in patients, including serious complications or side effects in connection with the use of Regenerons Products and Regenerons Product Candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict Regenerons ability to continue to develop or commercialize Regenerons Products and Regenerons Product Candidates, including without limitation Dupixent; ongoing regulatory obligations and oversight impacting Regenerons Products, research and clinical programs, and business, including those relating to patient privacy; the availability and extent of reimbursement of Regenerons Products from third-party payers, including private payer healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payers and new policies and procedures adopted by such payers; competing drugs and product candidates that may be superior to, or more cost effective than, Regenerons Products and Regenerons Product Candidates; the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators or licensees may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license, collaboration, or supply agreement, including Regenerons agreements with Sanofi, Bayer, and Teva Pharmaceutical Industries Ltd. (or their respective affiliated companies, as applicable) to be cancelled or terminated; and risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA (aflibercept) Injection, Dupixent, Praluent (alirocumab), and REGEN-COV (casirivimab and imdevimab), other litigation and other proceedings and government investigations relating to the Company and/or its operations, the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regenerons business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regenerons filings with the U.S. Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2021. Any forward-looking statements are made based on managements current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise. Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regenerons media and investor relations website (http://newsroom.regeneron.com) and its Twitter feed (http://twitter.com/regeneron). Attachment Source: West Corporation Apr 04, 2022: Banco Santander Press Release: Sanofi launches first-in-pharma Diversity, Equity & Inclusion Board Sanofi launches first-in-pharma Diversity, Equity & Inclusion Board Paris, April 4, 2022. Sanofi launches today its Diversity, Equity & Inclusion (DE&I) Board, the first-of-its-kind in the pharmaceutical industry to feature outside advisors. Sanofis DE&I Board will include three of the most influential voices in the DE&I space as Board members appointed for 3 years: organizational psychologist & best-selling author John Amaechi, award-winning social entrepreneur Caroline Casey, and DE&I pioneer and renowned thought-leader Dr. Rohini Anand. Sanofis DE&I strategy was revamped in June 2021 with set objectives toward 2025, built around three key pillars: building representative leadership, creating a work environment where employees can bring their whole selves and engaging with the companys diverse communities. The DE&I Boards role is to ensure Sanofis DE&I strategy is rightly executed, to monitor progress on the companys 2025 targets and to advise on how to accelerate the companys impact in this space. Together with the DE&I Board, Sanofi is launching a global Employee Resource Group (ERG) framework and five global focused ERGs: Gender+, Generations+, Pride+, Ability+ and Culture and Origins+, which will allow already existing local ERGs to scale and grow. ERGs are voluntary, employee-led groups that help create a diverse and inclusive workplace. Critical in supporting their members professional and personal growth and in cultivating a sense of belonging, they ensure the company reflects, values and listens to its diverse employees communities. Paul HudsonCEO of SanofiWere committed to driving diversity, equity and inclusion in Sanofi and beyond. These new initiatives will help us bring the outside in, so we can hear, listen and learn faster, and grow stronger as we continue our DE&I journey. The DE&I Board is composed of eleven members, including seven members from Sanofis leadership - Paul Hudson, Chief Executive Officer, Natalie Bickford, Chief People Officer, Olivier Charmeil, Head of General Medicines, Roy Papatheodorou, General Counsel & Head of Legal, Ethics & Business Integrity, John Reed, Head of Research & Development, Thomas Triomphe, Head of Vaccines, and Raj Verma, Chief Diversity, Culture & Experience Officer. Raj Verma will chair the DE&I Board. One member will be one of the companys five global Employee Resource Group Leads, with rotation among all global ERG Leads on an annual basis. The DE&I Board will meet 3 times per year and progress on the 2025 targets will continue to be communicated on a quarterly basis. John Amaechi I am always excited to support organizations looking to ensure that whether for colleagues, stakeholders or consumers - they stand for fairness, equity and the preservation of human dignity. I am a scientist first and bring an understanding of what can work to performance through improving inclusion and equity in the context of a large, complex multinational company with a strong history and tradition. Its clear there are many strong advocates within the company, and I am delighted to add my insights and expertise to those already present within Sanofi. Dr. Rohini Anand I am thrilled to join Sanofis DE&I Board as it affords me an opportunity to influence the critical need to address health care disparities globally. With my experience in leading global DE&I transformations I am motivated to support Sanofi as it seeks to foster an equitable and inclusive culture that enables breakthrough innovations because it is the desired destination for diverse talent. I am impressed by the authenticity and humility with which the leadership approaches DE&I and its willingness and openness to learn from external thought leaders. Caroline Casey Its a real honour to be joining the Sanofi DE&I Board which will support the strategic evolution of Business Inclusion focusing on the complex intersectional nature of diversity, equity, and inclusion. As a supporter of removing the decisive siloed approach which has and continues to create exclusion and mistrust, I am proud to bring the voice of disability business inclusion front and centre of Sanofis strategy both as a person with lived experience and as the founder of The Valuable 500. Sanofis DE&I Board external members John Amaechi is an organizational psychologist, best-selling author, Chartered Scientist (CSci), elected Fellow of the Royal Society for Public Health, Research Fellow at the University of East London, and Founder of APS Intelligence. A former NBA sportsman, John Amaechi serves as a mentor to many, a teacher to some, and always uses his deep psychological insight combined with real life experience to provide a touchstone for people and companies who want to thrive, achieve and align their beliefs, values and ethics. Dr. Rohini Anand, is a strategic business leader, Board member and author. With expertise that spans executive leadership, human capital, global corporate responsibility, wellness and diversity equity and inclusion, Rohini brings a unique perspective on the critical alignment of the business culture and the triple bottom line (People, Planet, Profit) to drive exceptional performance. Most recently Rohini was Senior Vice-President Corporate Responsibility and Global Chief Diversity Officer for Sodexo. Caroline Casey is a businesswoman and activist, founder of The Valuable 500, the worlds largest CEO collective and business move for disability inclusion. Recently appointed President of the International Agency for the Prevention of Blindness (IAPB), Caroline also sits on several Diversity and Inclusion Boards to include LOreal and Sky. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Media RelationsSandrine Guendoul|+ 33 6 25 09 14 25 |sandrine.guendoul@sanofi.comEvan Berland | + 1 215 432 0234 | evan.berland@sanofi.comKate Conway | +1 617 685 5326 | kate.conway@sanofi.comVictor Rouault|+ 33 6 70 93 71 40 |victor.rouault@sanofi.com Investor RelationsEva Schaefer-Jansen|+ 33 7 86 80 56 39 |eva.schaefer-jansen@sanofi.comCorentine Driancourt|+ 33 6 40 56 92 21 | corentine.driancourt@sanofi.comFelix Lauscher|+ 1908612 7239 | felix.lauscher@sanofi.com Attachment Press Release Source: West Corporation Apr 01, 2022: Banco Santander Press Release: EUROAPI listing on Euronext Paris expected on May 6, 2022 EUROAPI listing on Euronext Paris expected on May 6, 2022 French AMF approved EUROAPIs listing prospectus EUROAPI first day of trading expected to occur on May 6, 2022 subject to the approval of the Distribution by the Ordinary and Extraordinary Shareholders Meeting to be held on May 3, 2022 Sanofi will host today a dedicated Capital Markets Day at 1:30 pm CET to present EUROAPIs business in greater detailThe Distribution ratio will be one (1) EUROAPI share per twenty three (23) Sanofi sharesAfter the Distribution, Sanofi has confirmed its intention to hold circa 30% of the share capital and voting rights of EUROAPI, and EPIC Bpifrance, acting on behalf of the French State under the French Tech Sovereignty Convention of December 11, 2020, would hold 12% of the share capital and voting rights of EUROAPI and circa 58% of EUROAPIs shares will be distributed via a dividend in kind. LOreal, Sanofis largest shareholder, has committed to a lock-up period of 1 year following the settlement of the Distribution, i.e., May 10, 2022 Paris, April 1, 2022. Sanofi announced today that the French Autorite des marches financiers (AMF) has approved the listing prospectus prepared by EUROAPI in connection with the intended listing of its shares on the regulated market of Euronext Paris. On March 17th, 2022, Sanofis Board of Directors unanimously decided to submit for approval to its shareholders the proposed distribution in kind (the Distribution) of EUROAPI shares, via an additional extraordinary dividend, exclusively in kind, in addition to the previously proposed 3.33 cash dividend per Sanofi share. The Distribution relates to circa 58% of the share capital and voting rights of EUROAPI. In connection with the proposed Distribution, EPIC Bpifrance has agreed to purchase 12% of EUROAPI shares1 from Sanofi, which confirmed its intention to hold circa 30% of the share capital and voting rights of the company after the Distribution. The Distribution by Sanofi to its shareholders of EUROAPI shares in the form of an additional extraordinary dividend, exclusively in kind, is subject to the shareholders approval at Sanofis May 3, 2022 Ordinary and Extraordinary Shareholders Meeting. Subject to certain customary exceptions, the following lock-up periods have been agreed: 2 years for Sanofi and EPIC Bpifrance following the settlement and delivery of the EUROAPI shares to be sold to EPIC Bpifrance; and1 year for LOreal, Sanofis largest shareholder and for Karl Rotthier, CEO of the Company, following the settlement of the Distribution. Main features of the Distribution are as follows: The Distribution ratio will be one (1) EUROAPI share per twenty three (23) Sanofi shares. No fractional EUROAPI shares will be issued. Any right to receive a fractional share will not be tradable or transferable. Consequently, when the amount of the Distribution to which a Sanofi shareholder is entitled does not correspond to a whole number of EUROAPI shares (i.e., less than twenty three (23) or a multiple of twenty three (23) Sanofi shares), the shareholder will receive the immediately lower number of EUROAPI shares, plus a cash payment for the whole of the balance arising from the price at which EUROAPI shares corresponding to fractional shares were sold. Each financial intermediary will sell the shares corresponding to the fractional shares of its entitled clients. As a result, the amount of the cash balance may vary depending on the shareholders financial intermediary; The technical reference price of EUROAPI shares is expected to be announced on May 5, 2022 by Euronext Paris after market close; The admission to trading of the EUROAPI shares and the ex-date (detachement) of the Distribution will occur at 9.00 am (CET) on May 6, 2022;The record date (the date on which positions are closed) for Sanofi shares to be eligible to the Distribution is scheduled on May 9, 2022;Payment of the Distribution (delivery and book-entry of the allocated EUROAPI shares) will take place on May 10, 2022. Following the Distribution and the purchase of 12% of EUROAPI shares by EPIC Bpifrance, the Sanofi group will no longer control EUROAPI, resulting in a slightly accretive impact on Sanofi 2022 business operating income (BOI) margin2. Documents related to Sanofi shareholders meeting will be made available on April 11, 2022 on the Sanofi dedicated web page. Investors are invited to read EUROAPIs press release, issued concurrently and available on EUROAPIs website announcing the AMFs approval of its prospectus, and the listing prospectus in order to fully understand the potential risks and rewards associated with any decision to invest in EUROAPI shares. EUROAPI draws attention to the risk factors contained in Chapter 3 and Section 22.2 of the listing prospectus. The occurrence of one or more of these risks may have a significant adverse effect on the business, reputation, financial condition, results of operations or prospects of EUROAPI, as well as on the market price of EUROAPIs shares. For information on the tax treatment of the Distribution, shareholders are invited to read Paragraph 22.1.6 of the listing prospectus. Copies of the French-language listing prospectus, approved by the AMF on March 31, 2022 under number 22-076, are available free of charge and on request from EUROAPI at EUROAPIs registered office, 15 rue Traversiere, 75012 Paris, France, as well as on the websites of the AMF (https://www.amf-france.org), Sanofi (https://www.sanofi.com) and EUROAPI (listing.euroapi.com). An English-language information document for non-French resident shareholders of Sanofi is also available on Sanofis and EUROAPIs website. BNP Paribas, BofA Securities Europe SA, and J.P. Morgan SE are acting as Lead ECM Advisors to EUROAPI and Sanofi and Credit Agricole Corporate and Investment Bank, Deutsche Bank, Natixis SA and Societe Generale are acting as Other ECM Advisors in the contemplated listing. Rothschild & Co. is acting as independent financial adviser to Sanofi and EUROAPI. Jones Day is acting as a legal advisor to EUROAPI and Sanofi in connection with the Distribution, and White & Case as legal advisor to the Lead ECM Advisors. Capital Markets Day details Today, Sanofi will host a EUROAPI-dedicated Capital Markets Day at 1:30 pm CET and will cover the following topics: Execution of the Play to Win strategy with the spin-off of EUROAPIMain features of the Distribution Sanofis long-term commitment to EUROAPI: strong business relationship and future ownership structure alongside with EPIC BpifranceEUROAPIs deconsolidation impact for Sanofi Presentation of EUROAPI, including its business model, strategy and guidance. For background slides and webcast information, please refer to the following link on Sanofi website:https://www.sanofi.com/en/investors/financial-results-and-events/investor-presentations/Capital-Markets-Day-on-Euroapi-Webinar-2022. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Media RelationsSandrine Guendoul|+ 33 6 25 09 14 25 |sandrine.guendoul@sanofi.comVictor Rouault|+ 33 6 70 93 71 40 | victor.rouault@sanofi.com Investor Relationsinvestor.relations@sanofi.com France:+ 33 1 53 77 45 45 |U.S.:+ 1 908 981 5560 Shareholders hotline France : + 33 8 05 29 21 06 International: + 33 9 86 87 80 65 NoticeThis press release is intended for information purposes only and does not constitute a prospectus within the meaning of Regulation (EU) 2017/1129 of the European Parliament and of the Council of June 14, 2017, as amended (the Prospectus Regulation), and shares of EUROAPI will be distributed in circumstances that do not constitute an offer to the public within the meaning of the Prospectus Regulation. This press release constitutes an advertisement for the purposes of the Prospectus Regulation relating to the intention of EUROAPI to proceed with its proposed listing on the regulated market of Euronext Paris (the Admission). This press release does not constitute or form a part of any offer or solicitation to purchase or subscribe for securities in France, the United Kingdom, the United States of America, Canada, Australia, Japan or any other jurisdiction. No communication and no information in respect of the dividend distribution of the shares of EUROAPI (the Shares) may be sent to the public in any jurisdiction where a registration or approval is required. Any distribution of the Shares may be subject to specific legal or regulatory restrictions in certain jurisdictions. Neither Sanofi nor EUROAPI assumes any responsibility for any violation of any such restrictions by any person. Further details about the Admission are included in the listing prospectus issued by EUROAPI (the Prospectus). Investors should read the Prospectus in order to fully understand the potential risks and rewards associated with any decision to invest in the Shares, including the risk factors included in the Prospectus. The approval of the Prospectus by the French Autorite des marches financiers (AMF) should not be understood as an endorsement of the quality of the Shares and/or EUROAPI, including its financial position. The ECM Advisors are acting exclusively for EUROAPI and Sanofi and no one else in connection with the contemplated distribution and listing and will not regard any other person as their respective clients and will not be responsible to anyone other than EUROAPI and Sanofi for providing the protections afforded to their respective clients in connection with any distribution of shares of EUROAPI or otherwise, nor for providing any advice in relation to the distribution of shares, the content of this press release or any transaction, arrangement or other matter referred to herein. None of the ECM Advisors or any of their respective directors, officers, employees, advisers or agents accepts any responsibility or liability whatsoever for or makes any representation or warranty, express or implied, as to the accuracy or completeness of the information in this press release (or whether any information has been omitted from this press release) or any other information relating to EUROAPI, Sanofi, their respective subsidiaries or associated companies, whether written, oral or in a visual or electronic form, and howsoever transmitted or made available or for any loss howsoever arising from any use of this announcement or its contents or otherwise arising in connection therewith. Notice to holders of American Depositary Receipts (ADRs)As the record holder for all Sanofi shares represented by ADRs, JP Morgan, as Depositary, will receive shares of EUROAPI in the Distribution on behalf of Sanofis ADR holders. The Depositary has deemed that the distribution of EUROAPI shares to ADR holders is not feasible. Accordingly, pursuant to the terms of the deposit agreement between the Depositary, Sanofi and the owners and beneficial owners of American Depositary Receipts, the Depositary will sell the EUROAPI shares and distribute the net cash proceeds of the sale to ADR holders on the relevant record date. Sanofi Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words expects, anticipates, believes, intends, estimates, plans and similar expressions. Although Sanofis management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things Sanofis and EUROAPIs ability to benefit from external growth opportunities, to complete related transactions (notably the planned distribution of 58% of EUROAPI share capital and its listing on the regulated market of Euronext Paris) and/or obtain regulatory clearances, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that COVID-19 and recent armed conflicts will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. Any material effect of COVID-19 or recent armed conflicts on any of the foregoing could also adversely impact us. This situation is changing rapidly and additional impacts may arise of which we are not currently aware and may exacerbate other previously identified risks. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under Risk Factors and Cautionary Statement Regarding Forward-Looking Statements in Sanofis annual report on Form 20-F for the year ended December 31, 2021. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements RoundingCertain calculated figures (including data expressed in thousands or millions) and percentages presented in this press release have been rounded. Where applicable, the totals presented in this this press release may slightly differ from the totals that would have been obtained by adding the exact amounts (not rounded) for these calculated figures. They may also differ from the figures that are not rounded presented in the Prospectus. 1 EPIC Bpifrance has agreed to purchase 12% in EUROAPI shares from Sanofi for up to 150 million, with the acquisition price to be determined based upon the thirty day volume weighted average trading price (VWAP) of EUROAPIs shares on Euronext Paris, starting on the first day of trading. 2 Business Operating Incomemargin is a non GAAP indicator, for a definition see Form 20-F 2021 Item 5 A.1.5. 2/ p55. Attachment Press Release Source: West Corporation Mar 31, 2022: Banco Santander Press Release: Sanofi successfully priced an inaugural sustainability-linked bond indexed on access to medicines Sanofi successfully priced an inaugural sustainability-linked bond indexed on access to medicines Paris, March 31, 2022. Sanofi successfully priced yesterday, March 30, 2022, its offering of a dual-tranche EUR 1.5 billion of notes (the Notes). It comprises an inaugural issue of sustainability-linked bond for a nominal amount of EUR 650 million of notes, tied to Sanofis commitment to improve access to essential medicines in low- and lower-middle-income countries via its global health nonprofit unit. This transaction demonstrates Sanofis commitment to society, to ensure access to healthcare for the worlds vulnerable people. Jean-Baptiste de ChatillonChief Financial Officer of SanofiA year after pioneering sustainable finance with our sustainability-linked revolving credit facilities, we further contribute to the development of the sustainable finance market through the successful pricing of our first sustainability-linked bond said Jean-Baptiste de Chatillon, Chief Financial Officer of Sanofi. We continue to make progress in our environmental, social and governance activities that are an essential part of our strategy and embedded into our business. The Notes consist of two tranches: 850 million fixed rate notes, due April 2025, bearing interest at an annual rate of 0.875%. 650 million fixed rate notes, due April 2029, bearing interest at an annual rate of 1.250%. The coupon amounts are linked to the achievement of a sustainability performance target defined as the cumulative number of patients, being at least 1.5 million patients, provided with essential medicines by the global health unit, for the treatment of non-communicable diseases in 40 of the worlds poorest countries, between 2022 and 2026. Sandrine Bouttier-StrefGlobal Head of Corporate Social Responsibility of SanofiLinking the cost of financing to the achievement of concrete targets in terms of access to medicines confirms our determination to put social responsibility at the center of our ambitions. Sanofis expanded social impact strategy aims to build a healthier, more resilient world by ensuring access to healthcare for the worlds poorest people and bringing a much needed focus to the development of treatment for childhood cancer. Integrated into the companys Play to Win business strategy, Sanofis commitment to society will continue the fight against infectious diseases such as sleeping sickness and poliomyelitis, while accelerating its goals to reduce the environmental impact of its products and its worldwide operations. Key to tackling the global challenges that face society are its people, who each have a role to play in building a diverse and inclusive workplace. To become an issuer of sustainable finance instruments, Sanofi has established a dedicated Sustainability-Linked Bond Framework, designed as a living document to enable future bond issues in a sustainability-linked format. The Sustainability-Linked Bond Framework is aligned with ICMAs Sustainability-Linked Bond Principles (2020) and has received a Second Party Opinion from ISS ESG. The proceeds of the bond issue will be used for general corporate purposes. The transaction has been led by Morgan Stanley and Natixis CIB as Global Coordinators & Sustainability-Linked Structuring Advisors and, Barclays, MUFG and RBC Capital Markets, all as Joint Active Bookrunners. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Media RelationsSandrine Guendoul | + 33 6 25 09 14 25 | sandrine.guendoul@sanofi.comSally Bain|+ 1 617 834 6026 |sally.bain@sanofi.comVictor Rouault|+ 33 6 70 93 71 40 |victor.rouault@sanofi.com Investor RelationsEva Schaefer-Jansen|+ 33 7 86 80 56 39 |eva.schaefer-jansen@sanofi.comArnaud Delepine|+ 33 6 73 69 36 93 | arnaud.delepine@sanofi.comCorentine Driancourt|+ 33 6 40 56 92 21 | corentine.driancourt@sanofi.comFelix Lauscher|+ 1908612 7239 | felix.lauscher@sanofi.com DisclaimerThis communication shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. The Notes have not been and will not be registered under the U.S. Securities Act of 1933, as amended (the Securities Act) and may not be sold in the United States absent registration or an exemption from registration under the Securities Act. This communication is only addressed to and directed at persons in member states of the European Economic Area ("EEA") who are qualified investors within the meaning of Article 2(e) of Regulation (EU) 2017/1129, as amended (the "Prospectus Regulation").MiFID II professionals/ECPs-only Manufacturer target market (MiFID II product governance) is eligible counterparties and professional clients only (all distribution channels). No EU PRIIPs key information document (KID) has been prepared as the securities will not be available to retail in the EEA.UK MiFIR professionals/ECPs-only Manufacturer target market (UK MiFIR product governance) is eligible counterparties and professional clients only (all distribution channels). No UK PRIIPs key information document (KID) has been prepared as the securities will not be available to retail in the UK.This communication may only be communicated in France to qualified investors (investisseurs qualifies) as defined in, and in accordance with, Article 2(e) of the Prospectus Regulation and Articles L.411 -1 and L.411-2 of the French Code monetaire et financier.This communication does not constitute an offer of the securities to the public in the United Kingdom. This communication is being distributed to and is directed only at (i) persons who are outside the United Kingdom, (ii) persons who have professional experience in matters relating to investments falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the "Order"), (iii) persons who are high net worth entities falling within Article 49(2)(a) to (d) of the Order, or (iv) are other persons to whom they may otherwise lawfully be communicated (all such persons together being referred to as "Relevant Persons"). Any investment activity to which this communication relates will only be available to and will only be engaged with, Relevant Persons. Any person who is not a Relevant Person should not act or rely on this document or any of its contents. Sanofi Forward-Looking StatementsThis press release contains forward-looking statements. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words expects, anticipates, believes, intends, estimates, plans and similar expressions. Although Sanofis management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofis ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. Any material effect of COVID-19 on any of the foregoing could also adversely impact us. This situation is changing rapidly and additional impacts may arise of which we are not currently aware and may exacerbate other previously identified risks. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under Risk Factors and Cautionary Statement Regarding Forward-Looking Statements in Sanofis annual report on Form 20-F for the year ended December 31, 2021. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. Sanofi does not undertake to make any updates to information or forward-looking statements above subject to its obligations under applicable regulations, inlcudign Article 223-1 and thereafter of the Reglement general of the AMF. Attachment Press_Release Source: West Corporation Mar 30, 2022: Banco Santander Press Release: Availability of the Q1 2022 Memorandum for modelling purposes Availability of the Q1 2022 Memorandum for modelling purposes Paris, March 30, 2022. Sanofi announced today that its Q1 2022 Memorandum for modelling purposes is available on the "Investors" page of the company's website: https://www.sanofi.com/en/investors/financial-results-and-events/financial-results/Q1-results-2022 As for each quarter, Sanofi prepared this document to assist in the financial modelling of the Group's quarterly results. This document includes a reminder on various non-comparable items and exclusivity losses as well as the foreign currency impact and share count. Sanofi's first-quarter 2022 results will be published on April 28, 2022. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Media RelationsSandrine Guendoul|+ 33 6 25 09 14 25 |sandrine.guendoul@sanofi.comSally Bain|+ 1 617 834 6026 |sally.bain@sanofi.comVictor Rouault|+ 33 6 70 93 71 40 |victor.rouault@sanofi.com Investor RelationsEva Schaefer-Jansen|+ 33 7 86 80 56 39 |eva.schaefer-jansen@sanofi.comArnaud Delepine|+ 33 6 73 69 36 93 | arnaud.delepine@sanofi.comCorentine Driancourt|+ 33 6 40 56 92 21 | corentine.driancourt@sanofi.comFelix Lauscher|+ 1908612 7239 | felix.lauscher@sanofi.comPriya Nanduri| +1 908 981 5560 |priya.nanduri@sanofi.com Nathalie Pham|+ 33 7 85 93 30 17 | nathalie.pham@sanofi.com Sanofi Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words expects, anticipates, believes, intends, estimates, plans and similar expressions. Although Sanofis management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofis ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. Any material effect of COVID-19 on any of the foregoing could also adversely impact us. This situation is changing rapidly and additional impacts may arise of which we are not currently aware and may exacerbate other previously identified risks. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under Risk Factors and Cautionary Statement Regarding Forward-Looking Statements in Sanofis annual report on Form 20-F for the year ended December 31, 2021. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. Attachment Press Release Source: West Corporation Mar 29, 2022: Banco Santander Press Release: Sanofi and IGM Biosciences Announce Collaboration Agreement for Oncology, Immunology and Inflammation Targets Sanofi and IGM Biosciences Announce Collaboration Agreement for Oncology, Immunology and Inflammation Targets * Companies to leverage proprietary IgM antibody technology platform to discover agonists against three oncology targets and three immunology/inflammation targets * Collaboration to create, develop, manufacture and commercialize new class of potential therapeutics combining the superior features of multi-valent IgM antibodies over conventional IgG antibodies for stimulating cell surface receptors * IGM to receive $150 million upfront payments, potentially over $6 billion in aggregate development, regulatory and commercial milestones Paris, March 29, 2022 Sanofi (NASDAQ: SNY) and IGM Biosciences, Inc. (Nasdaq: IGMS) today announced the signing of an exclusive worldwide collaboration agreement to create, develop, manufacture, and commercialize IgM antibody agonists against three oncology targets and three immunology/inflammation targets. Engineered IgM antibodies represent a new class of potential therapeutics that combine the multi-valency of IgM antibodies possessing 10 binding sites compared to conventional IgG antibodies having only 2 target binding sites. John Reed, M.D., Ph.D.Global Head of Research and Development, SanofiWe look forward to this collaboration with IGM Biosciences, a pioneer in a new class of antibody medicines for the treatment of cancer, immunology, and inflammatory diseases. The IGM Biosciences technology platform offers an exciting approach to developing high-avidity IgM antibodies that can efficiently bind and stimulate the activity of cell surface receptors. This unique platform has the potential to overcome historical limitations of conventional IgG antibodies when seeking agonists of some classes of receptors. Fred SchwarzerChief Executive Officer of IGM BiosciencesSanofi is a global leader in the development and commercialization of innovative therapies, and we welcome the addition of their extensive expertise and resources in expanding and accelerating the development of our IgM antibody platform across multiple areas of high unmet need.This partnership builds on an existing research collaboration with Sanofi and is a key step towards our goal of unlocking the full breadth of potential for this important new class of therapeutics. We are pleased to share this vision with Sanofi and look forward to working together on these six potentially first- and best-in-class programs. Terms of the CollaborationUnder the terms of the agreement, IGM will receive a $ 150 million upfront payment. Sanofi has also expressed an interest in purchasing up to $100M of IGM non-voting common stock in a public financing. For each oncology target collaboration program, IGM will lead research and development activities, and assume related costs, through approval of the first biologics license application (BLA) for a product directed to that oncology target by the FDA or EMA in exchange for up to $940 million in development and regulatory milestones per oncology target. After receipt of the first marketing approval for a product directed to an oncology target, Sanofi will lead all subsequent development and commercialization activities for that oncology target. For each oncology target, the companies will share profits 50:50 in certain major markets, and IGM will be eligible to receive tiered royalties on net sales in the rest of world. For each immunology/inflammation target collaboration program, IGM will lead research and development activities, and assume related costs, through the completion of Phase 1 clinical trial for up to two constructs directed to each immunology/inflammation target, after which Sanofi will be responsible for all future development and related costs, in exchange for up to $1,065 million in aggregate development and regulatory and commercial milestones per immunology/inflammation target. Following the completion of Phase 1 clinical trial for each immunology/inflammation target, Sanofi will be responsible for subsequent development activities, commercialization efforts, and related costs. IGM is eligible to receive tiered high single-digit to low-teen royalties on global net sales. Closing of the collaboration is contingent on completion of review under antitrust laws, including the Hart-Scott-Rodino (HSR) Antitrust Improvements Act of 1976 in the U.S., and customary closing conditions. About IGM Biosciences, Inc.Headquartered in Mountain View, California, IGM Biosciences is a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies. Since 2010, IGM Biosciences has worked to overcome the manufacturing and protein engineering hurdles that have limited the therapeutic use of IgM antibodies. Through its efforts, IGM Biosciences has created a proprietary IgM technology platform for the development of IgM antibodies for those clinical indications where their inherent properties may provide advantages as compared to IgG antibodies.IGM is listed on NASDAQ; IGMS About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Sanofi Media RelationsSandrine Guendoul|+ 33 6 25 09 14 25 |sandrine.guendoul@sanofi.comSally Bain|+ 1 617 834 6026 |sally.bain@sanofi.comKate Conway|+ 1508 364 4931 |kate.conway@sanofi.com Sanofi Investor RelationsEva Schaefer-Jansen|+ 33 7 86 80 56 39 |eva.schaefer-jansen@sanofi.comArnaud Delepine|+ 33 6 73 69 36 93 | arnaud.delepine@sanofi.comCorentine Driancourt|+ 33 6 40 56 92 21 | corentine.driancourt@sanofi.comFelix Lauscher|+ 1908612 7239 | felix.lauscher@sanofi.comPriya Nanduri| +1 908 981 5560 |priya.nanduri@sanofi.com Nathalie Pham|+ 33 7 85 93 30 17 | nathalie.pham@sanofi.com IGM Biosciences Media RelationsDavid Pitts | +1 212 600 1902 | igmbio@argotpartners.com Sanofi Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words expects, anticipates, believes, intends, estimates, plans and similar expressions. Although Sanofis management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofis ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. Any material effect of COVID-19 on any of the foregoing could also adversely impact us. This situation is changing rapidly and additional impacts may arise of which we are not currently aware and may exacerbate other previously identified risks. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under Risk Factors and Cautionary Statement Regarding Forward-Looking Statements in Sanofis annual report on Form 20-F for the year ended December 31, 2021. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. IGM Biosciences, Forward-Looking Statements This press release contains forward-looking statements, including statements relating to plans, expectations and forecasts and to future events. Such forward-looking statements include, but are not limited to: the potential of, and expectations regarding, IGMs technology platform and its IgM antibodies; expectations regarding the transaction between IGM and Sanofi, including all financial aspects of the collaboration and an equity investment; the potential benefits and results of such transaction, including goals of the collaboration and the potential for accelerated development of IGMs platform; plans and expectations regarding research, development and commercialization efforts and activities; and statements by IGMs Chief Executive Officer. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially, including but not limited to: potential delays and disruption resulting from the COVID-19 pandemic and governmental responses to the pandemic, including any future impacts to IGMs operations, the manufacturing of its product candidates, the progression of its clinical trials, enrollment in its current and future clinical trials and progression of its collaborations and related efforts; the risks that the transaction between IGM and Sanofi may not be completed in a timely manner or at all; the possibility that certain closing conditions to the transaction will not be satisfied, including the risks related to obtaining the requisite regulatory approvals, such as those required under antitrust laws; the risk of the occurrence of any event, change or other circumstance that could give rise to the termination of collaboration agreement between IGM and Sanofi (including without limitation the failure to timely obtain requisite regulatory approvals); the possibility that Sanofi may not invest in IGM; risks related to the effect of the announcement of the transaction on IGMs business relationships, operating results, stock price and business generally; IGMs early stages of clinical drug development; risks related to the use of engineered IgM antibodies, which is a novel and unproven therapeutic approach; IGMs ability to demonstrate the safety and efficacy of its product candidates; IGMs ability to successfully and timely advance its product candidates through preclinical studies and clinical trials; IGMs ability to enroll patients in its clinical trials; the potential for the results of clinical trials to differ from preclinical, preliminary, initial or expected results; the risk of significant adverse events, toxicities or other undesirable side effects; IGMs ability to successfully manufacture and supply its product candidates for clinical trials; the potential impact of continuing or worsening supply chain constraints; the risk that all necessary regulatory approvals cannot be obtained; the potential market for IGMs product candidates, IGMs ability to obtain additional capital to finance its operations, if needed; uncertainties related to the projections of the size of patient populations suffering from the diseases IGM is targeting; IGMs ability to obtain, maintain and protect its intellectual property rights; developments relating to IGMs competitors and its industry, including competing product candidates and therapies; general economic and market conditions; and other risks and uncertainties, including those more fully described in IGMs filings with the Securities and Exchange Commission (SEC), including IGMs Annual Report on Form 10-K filed with the SEC on March 30, 2021, IGMs Quarterly Report on Form 10-Q filed with the SEC on November 4, 2021 and in IGMs future reports to be filed with the SEC. Any forward-looking statements contained in this press release speak only as of the date hereof, and IGM specifically disclaims any obligation to update any forward-looking statement, except as required by law. Attachment Source: West Corporation Mar 29, 2022: Banco Santander Press Release: Sanofi continues on path to industry leadership in Immunology with Dupixent (dupilumab) as key driver Sanofi continues on path to industry leadership in Immunology with Dupixent (dupilumab) as key driver Dupixent peak sales ambition raised to more than 13 billion Chronic obstructive pulmonary disease 2023 pivotal readouts provide potential for additional Dupixent sales ambition upgrade13 potential new medicines currently in the clinic to treat chronic inflammatory diseases, with 17 readouts expected by the end of 2024 Paris, March 28, 2022. Tomorrow, Sanofi will host an Immunology Investor Event with key members of the leadership team providing updates on how the company is advancing its Immunology strategy, including the ambition to more than quadruple Immunology franchise sales by the end of the decade. The focus of the event is on Dupixent (dupilumab), a key growth driver, and Sanofis rapidly advancing pipeline, highlighting dermatological, respiratory and gastrointestinal diseases as priority therapeutic areas. Sanofi has raised the Dupixent sales peak ambition to more than 13 billion. This new ambition does not include potential for additional sales ambition upgrade from chronic obstructive pulmonary disease (COPD), with pivotal readouts anticipated in 2023. For more than a decade Sanofi, in collaboration with Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN), has been advancing the science of diseases driven by type 2 inflammation. Dupixent is now a market leader and more than 400,000 patients with certain types of atopic dermatitis (AD), asthma and chronic rhinosinusitis with nasal polyposis have been treated globally. By 2025, Dupixent is expected to generate an additional 11 new regulatory submissions across indications and age groups. Bill SiboldExecutive Vice President, Head of Global Specialty Care, SanofiIn the five years since launch, Dupixent has excelled in improving the lives of patients with diseases driven by type 2 inflammation. This truly unique medicine is only at the beginning of its journey to helping potentially millions of patients. Beyond Dupixent, we are committed to delivering the next generation of novel medicines that we hope will change the practice of medicine in chronic inflammatory diseases beyond type 2 inflammation. We are committed to moving with the utmost urgency to bring new medicines to patients that address their individual needs, offering choice and hope. Sanofis novel pipeline is comprised of 13 next-generation medicines designed to target mechanisms beyond type 2 inflammation. Our Research & Development (R&D) teams are following the science to control chronic inflammation and collaborating with leading experts across all sectors to address both urgent and growing patient needs. We are focused on targets with the most potential to alter the course of immune-based diseases, from the mildest to the most severe, using novel technologies that unlock previously inaccessible biology. These drug discovery platforms, for example, synthetic biology, TAILORED COVALENCY chemistry, and multispecific NANOBODY molecules, are allowing Sanofi to pursue both injectable and oral therapeutics. Sanofis attack in immunological diseases also entails precision medicine approaches that aim to remove the guess-work from clinical practice by treating the right patients, with the right medicines, at the right time. John Reed, M.D., Ph.D.Global Head of Research and Development, SanofiOur long-term strategy goes well beyond Dupixent to deliver best-in-class medicines that break efficacy ceilings and help patients with chronic inflammatory diseases achieve long-term disease modification. We are pursuing this ambition through precision medicine approaches that leverage our proprietary technologies, such as our NANOBODY platform that can help us address multiple therapeutic targets with one medicine. With approximately 21 clinical readouts expected across our promising immunology pipeline by the end of next year, it is an exciting time for our team working in Immunology R&D. Sanofi will highlight the following assets in its growing R&D pipeline: Three candidates for AD, complementing Dupixents position in AD driven by type 2 inflammation, spanning all severities of disease as well as topical, oral and injectable administration. These drug development programs include our acceleration of priority asset amlitelimab, an anti-OX40L antibody that aims to restore immune homeostasis between pro-inflammatory and anti-inflammatory T cells.Two complementary candidates for COPD, developed in collaboration with Regeneron, targeting distinct subpopulations.A broad Phase 1 clinical program of small molecules and biologics. These candidate medicines include oral small molecules, degraders, synthetic cytokines, and several NANOBODY molecules, designed to simultaneously tackle two proven targets, thus aiming to break efficacy ceilings. Immunology Investor Event Details The hybrid Immunology Investor Event will take place on Tuesday, March 29 from 2 p.m. to 6 p.m. CEST / 8 a.m. to noon EDT (webcast, in-person meeting at Sanofis Cambridge office). For background slides and webcast information, please refer to the following link. The information will be available beginning Tuesday, March 29 at 1 p.m. CEST / 7 a.m. EDT.https://www.sanofi.com/en/investors/financial-results-and-events/investor-presentations/Immunology-Investor-Event-2022 About Our Inflammatory Pipeline Through world-class R&D and a laser focus on patients, Sanofi discovers, develops and delivers best-in-class treatments that improve the lives of people living with chronic inflammatory diseases. The Immunology pipeline consists of 7 potential new medicines in Phase 1 clinical development, 5 in Phase 2 clinical development, and 1 in Phase 3 clinical development. These programs include potential treatments across a wide range of inflammatory conditions. Dupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement. In addition to the 3 currently approved indications, Sanofi and Regeneron are studying dupilumab in nearly a dozen other diseases. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Media RelationsSandrine Guendoul|+ 33 6 25 09 14 25 |sandrine.guendoul@sanofi.comSally Bain|+ 1 617 834 6026 |sally.bain@sanofi.com Investor RelationsEva Schaefer-Jansen|+ 33 7 86 80 56 39 |eva.schaefer-jansen@sanofi.comArnaud Delepine|+ 33 6 73 69 36 93 | arnaud.delepine@sanofi.comCorentine Driancourt|+ 33 6 40 56 92 21 | corentine.driancourt@sanofi.comFelix Lauscher|+ 1908612 7239 | felix.lauscher@sanofi.comPriya Nanduri|+1 617 764 6418 | priya.nanduri@sanofi.com Nathalie Pham|+ 33 7 85 93 30 17 | nathalie.pham@sanofi.com Sanofi Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements are generally identified by the words expects, anticipates, believes, intends, estimates, plans and similar expressions. Although Sanofis management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. Any material effect of COVID-19 on any of the foregoing could also adversely impact us. This situation is changing rapidly and additional impacts may arise of which we are not currently aware and may exacerbate other previously identified risks. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under Risk Factors and Cautionary Statement Regarding Forward-Looking Statements in Sanofis annual report on Form 20-F for the year ended December 31, 2021. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. Attachment Source: West Corporation Mar 28, 2022: Banco Santander Press Release: Xenpozyme (olipudase alfa) approved in Japan, first and only approved therapy indicated to treat acid sphingomyelinase deficiency Xenpozyme (olipudase alfa) approved in Japan, first and only approved therapy indicated to treat acid sphingomyelinase deficiency Xenpozyme represents first Sanofi therapy to be approved under the SAKIGAKE fast-track designationApproval based on positive results from two separate clinical trials in children and adults demonstrating improvement in lung function (as measured by DLco) and reduction of spleen and liver volumes Paris, March 28, 2022. The Japanese Ministry of Health, Labor, and Welfare (MHLW) has granted marketing authorization for Xenpozyme (olipudase alfa) for the treatment of adult and pediatric patients with non-central nervous system (non-CNS) manifestations of acid sphingomyelinase deficiency (ASMD), a rare, progressive, and potentially life-threatening genetic disease. Xenpozyme is currently the only approved treatment for ASMD and represents Sanofis first therapy to be approved under the SAKIGAKE (or pioneer) designation, which is the Japanese governments regulatory fast-track pathway to promote research and development of innovative new medical products addressing urgent unmet medical needs. John Reed, M.D., Ph.DExecutive Vice President, Global Head of Research and Development, SanofiTodays approval of Xenpozyme is a watershed moment for ASMD patients and their families, representing 20 years of research and the shared efforts of advocacy partners, clinicians, and patients. As the worlds first medicine approved for ASMD, Xenpozyme offers a potentially transformative option for this historically neglected community. We are proud of this achievement and grateful that Japans PDMA has recognized the significance of the unmet need that Xenpozyme addresses with the Sakigake designation. At Sanofi, we are working with health authorities globally, including the EU where olipudase alfa has PRIME designation and in the USA where this enzyme replacement therapy has Breakthrough designation, to rush this important medicine to ASMD patients around the world. Xenpozyme is a recombinant human acid sphingomyelinase enzyme developed to replace deficient or defective acid sphingomyelinase (ASM), an enzyme that allows for the breakdown of the lipid sphingomyelin. Accumulation of sphingomyelin in cells can cause harm to the lungs, spleen, and liver, as well as other organs, potentially leading to early death. The approval of Xenpozyme in Japan is based on positive results from the ASCEND and ASCEND-Peds clinical trials, showing that Xenpozyme provided improvement in lung function (as measured by diffusing capacity of the lung for carbon monoxide, or DLco)and reduction of spleen and liver volumes, with a well-tolerated safety profile in adults and children with ASMD. These data were presented at theAmerican Society of Human Genetics (ASHG) 2020 Virtual Meeting. Xenpozyme has been evaluated in children and adults to treat non-CNS manifestations of ASMD type A/B and ASMD type B. Xenpozyme has not been studied in patients with ASMD type A. Historically known as Niemann-Pick disease types A, A/B, and B, ASMD is a genetically-based, progressive, and potentially life-threatening disease. ASMD represents a spectrum of disease, with two types that may represent opposite ends of a continuum referred to as ASMD type A and ASMD type B. ASMD type A/B is an intermediate form that includes varying degrees of CNS involvement. Until now, no approved therapies for ASMD have been available anywhere in the world. Outside of Japan, olipudase alfa is being evaluated by regulatory authorities around the world. A Biologics License Application (BLA) for olipudase alfa was accepted for Priority Review by the U.S. Food and Drug Administration (FDA), with a decision expected early Q3 2022. The European Medicines Agency (EMA) has awarded olipudase alfa the PRIority MEdicines (PRIME) designation, and a decision is anticipated in the second half of 2022. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Media RelationsSally Bain|+ 1 617 834 6026 |sally.bain@sanofi.com Investor RelationsEva Schaefer-Jansen|+ 33 7 86 80 56 39 |eva.schaefer-jansen@sanofi.comArnaud Delepine|+ 33 6 73 69 36 93 | arnaud.delepine@sanofi.comCorentine Driancourt|+ 33 6 40 56 92 21 | corentine.driancourt@sanofi.comFelix Lauscher|+ 1908612 7239 | felix.lauscher@sanofi.comPriya Nanduri|+1 908 981 5560 | priya.nanduri@sanofi.com Nathalie Pham|+ 33 7 85 93 30 17 | nathalie.pham@sanofi.com Sanofi Forward-Looking Statements This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words expects, anticipates, believes, intends, estimates, plans and similar expressions. Although Sanofis management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofis ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. Any material effect of COVID-19 on any of the foregoing could also adversely impact us. This situation is changing rapidly and additional impacts may arise of which we are not currently aware and may exacerbate other previously identified risks. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under Risk Factors and Cautionary Statement Regarding Forward-Looking Statements in Sanofis annual report on Form 20-F for the year ended December 31, 2021. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. Attachment Press Release Source: West Corporation Mar 26, 2022: Banco Santander Press release: Late-breaking Phase 3 data at AAD 2022 show Dupixent (dupilumab) significantly improved signs and symptoms of prurigo nodularis Late-breaking Phase 3 data at AAD 2022 show Dupixent (dupilumab) significantly improved signs and symptoms of prurigo nodularis Dupixent significantly reduced itch at 12 weeks, and at 24 weeks nearly three times as many Dupixent patients experienced clinically meaningful reductions in itch and skin lesionsThere are currently no approved systemic treatments for prurigo nodularis; regulatory filings for prurigo nodularis planned in the first half of 2022 Paris and Tarrytown, N.Y. March 26, 2022. Detailed positive results from the Phase 3 PRIME2 trial evaluating the safety and efficacy of Dupixent (dupilumab) was presented today in a late-breaking session at the American Academy of Dermatology (AAD) 2022 Annual Meeting. The companies previously announced topline results from PRIME2 and a second trial called PRIME investigating the use of Dupixent in adults with uncontrolled prurigo nodularis. In both trials, Dupixent significantly reduced itch and skin lesions compared to placebo. In total, 21 scientific abstracts evaluating the safety and efficacy of Dupixent in patients with atopic dermatitis in different age groups, as well as investigational indications prurigo nodularis and chronic spontaneous urticaria will be presented at the congress. Gil Yosipovitch, M.D.Professor of Dermatology, Miller School of Medicine, University of Miami, and principal investigator of the PRIME2 trialPrurigo nodularis is a relentless and often misunderstood itchy skin disease that leaves many patients with uncontrolled symptoms such as unbearable itch and painful skin lesions, along with a significantly impaired quality of life that should not be underestimated. These positive results are the first time a Phase 3 trial has demonstrated that targeting key drivers of type 2 inflammation, IL-4 and IL-13, with dupilumab significantly improved itch and skin lesions in this highly burdensome disease. The randomized, placebo-controlled PRIME2 trial met primary and all key secondary endpoints with data presented at AAD 2022 showing: 37% of Dupixent patients experienced a clinically meaningful reduction in itch from baseline compared to 22% of placebo patients (p=0.0216) at week 12, the primary endpoint. Nearly three times as many Dupixent patients experienced a clinically meaningful reduction in itch from baseline at week 24: 58% of Dupixent patients compared to 20% of placebo patients (p<0.0001).Nearly three times as many Dupixent patients achieved clear or almost clear skin at week 24: 45% of Dupixent patients compared to 16% of placebo patients (p<0.0001). The safety results of the trial were generally consistent with the known safety profile of Dupixent in its approved dermatology indications. For the 24-week treatment period, overall rates of adverse events were generally similar between Dupixent and placebo groups (57% Dupixent, 51% placebo). Adverse events that were more commonly (>5%) observed with Dupixent were herpes viral infections (7% Dupixent, 0% placebo). A lower rate of skin infections were observed with Dupixent (5% Dupixent, 9% placebo). Additionally, 3% of Dupixent patients and 30% of placebo patients discontinued prior to week 24. Results from the confirmatory PRIME trial will be presented at an upcoming medical congress. Data from both trials will form the basis of regulatory submissions around the world for Dupixent in prurigo nodularis, which are planned to begin in the first half of 2022. The potential use of Dupixent in prurigo nodularis is currently under clinical development, and the safety and efficacy have not been fully evaluated by any regulatory authority. About Prurigo NodularisPeople with prurigo nodularis experience intense, persistent itch, with thick skin lesions (called nodules) that can cover most of the body. Prurigo nodularis is often described as painful with burning, stinging and tingling of the skin. The impact of uncontrolled prurigo nodularis on quality of life is one of the highest among inflammatory skin diseases due to the extreme itch and is comparable to other debilitating chronic diseases that can negatively affect mental health, activities of daily living and social interactions. High-potency topical steroids are commonly prescribed but are associated with safety risks if used long term. There are approximately 75,000 people in the U.S. who are unable to control their disease with systemic therapy and are most in need of a treatment option. About the TrialPRIME2, part of the LIBERTY-PN PRIME clinical program, is a randomized, Phase 3, double-blind, placebo-controlled trial that evaluated the efficacy and safety of Dupixent in 160 adults with prurigo nodularis inadequately controlled with topical prescription therapies or with whom those therapies were not advisable. During the 24-week treatment period, patients received Dupixent or placebo every two weeks with or without topical treatments (low- or medium-dose topical corticosteroids or topical calcineurin inhibitors were continued if patients were using these treatments at randomization). The primary endpoint evaluated the proportion of patients with clinically meaningful improvement in itch at week 12 (measured by a 4-point reduction in Worst-Itch Numeric Rating Scale [WI-NRS] of 0-10). Key secondary endpoints included the proportion of patients with clinically meaningful improvement in itch at week 24 and the proportion of patients with clear or almost clear skin at week 24 (measured by a score of 0 or 1 on the Investigator's Global Assessment PN-Stage [IGA PN-S] 0-4 scale). About DupixentDupixent is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not an immunosuppressant. IL-4 and IL-13 are key and central drivers of the type 2 inflammation that plays a major role in atopic dermatitis, asthma and chronic rhinosinusitis with nasal polyposis (CRSwNP). Dupixent is currently approved in the U.S., Europe, Japan and other countries around the world for use in specific patients with moderate-to-severe atopic dermatitis, as well as certain patients with asthma or CRSwNP in different age populations. Dupixent is also approved in one or more of these indications in more than 60 countries around the world and more than 400,000 patients have been treated globally. Dupilumab Development ProgramDupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement. To date, dupilumab has been studied in more than 60 clinical trials involving more than 10,000 patients with various chronic diseases driven in part by type 2 inflammation. In addition to the currently approved indications, Sanofi and Regeneron are studying dupilumab in a broad range of diseases driven by type 2 inflammation or other allergic processes, including prurigo nodularis (Phase 3), pediatric atopic dermatitis (6 months to 5 years of age, Phase 3), hand and foot atopic dermatitis (Phase 3), eosinophilic esophagitis (Phase 3), chronic spontaneous urticaria (Phase 3), bullous pemphigoid (Phase 3), chronic inducible urticaria-cold (Phase 3), chronic obstructive pulmonary disease with evidence of type 2 inflammation (Phase 3), chronic rhinosinusitis without nasal polyposis (Phase 3), allergic fungal rhinosinusitis (Phase 3), allergic bronchopulmonary aspergillosis (Phase 3) and peanut allergy (Phase 2). These potential uses of dupilumab are currently under clinical investigation, and the safety and efficacy in these conditions have not been fully evaluated by any regulatory authority. About Regeneron Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, hematologic conditions, infectious diseases and rare diseases. Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite technologies, such as VelocImmune, which uses unique genetically humanized mice to produce optimized fully human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world. For additional information about the company, please visit www.regeneron.com or follow @Regeneron on Twitter. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions.Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Sanofi Media RelationsSally Bain|+ 1 617 834 6026 |sally.bain@sanofi.com Sanofi Investor RelationsEva Schaefer-Jansen | + 33 7 86 80 56 39 | eva.schaefer-jansen@sanofi.com Arnaud Delepine | + 33 06 73 69 36 93 | arnaud.delepine@sanofi.com Corentine Driancourt | + 33 06 40 56 92 | corentine.driancourt@sanofi.com Felix Lauscher | + 1 908 612 7239 | felix.lauscher@sanofi.com Priya Nanduri | priya.nanduri@sanofi.com Nathalie Pham | + 33 07 85 93 30 17 | nathalie.pham@sanofi.com Regeneron Media RelationsHannah Kwagh | + 1 914 847 6314 | hannah.kwagh@regeneron.com Regeneron Investor RelationsVesna Tosic | + 914 847 5443 | vesna.tosic@regeneron.com Sanofi Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements are generally identified by the words expects, anticipates, believes, intends, estimates, plans and similar expressions. Although Sanofis management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. Any material effect of COVID-19 on any of the foregoing could also adversely impact us. This situation is changing rapidly and additional impacts may arise of which we are not currently aware and may exacerbate other previously identified risks. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under Risk Factors and Cautionary Statement Regarding Forward-Looking Statements in Sanofis annual report on Form 20-F for the year ended December 31, 2021. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. Regeneron Forward-Looking Statements and Use of Digital MediaThis press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. (Regeneron or the Company), and actual events or results may differ materially from these forward-looking statements. Words such as anticipate, expect, intend, plan, believe, seek, estimate, variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the impact of SARS-CoV-2 (the virus that has caused the COVID-19 pandemic) on Regenerons business and its employees, collaborators, and suppliers and other third parties on which Regeneron relies, Regenerons and its collaborators ability to continue to conduct research and clinical programs, Regenerons ability to manage its supply chain, net product sales of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, Regenerons Products), and the global economy; the nature, timing, and possible success and therapeutic applications of Regenerons Products and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, Regenerons Product Candidates) and research and clinical programs now underway or planned, including without limitation Dupixent (dupilumab) for the treatment of prurigo nodularis; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regenerons Product Candidates and new indications for Regenerons Products, such as Dupixent for the treatment of prurigo nodularis, chronic obstructive pulmonary disease with evidence of type 2 inflammation, pediatric atopic dermatitis, eosinophilic esophagitis, bullous pemphigoid, chronic spontaneous urticaria, chronic inducible urticaria-cold, chronic rhinosinusitis without nasal polyposis, allergic fungal rhinosinusitis, allergic bronchopulmonary aspergillosis, peanut allergy, and other potential indications; uncertainty of the utilization, market acceptance, and commercial success of Regenerons Products (such as Dupixent) and Regenerons Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary), including the studies discussed or referenced in this press release, on any of the foregoing or any potential regulatory approval of Regenerons Products (such as Dupixent) and Regenerons Product Candidates; the ability of Regenerons collaborators, licensees, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regenerons Products and Regenerons Product Candidates; the ability of Regeneron to manage supply chains for multiple products and product candidates; safety issues resulting from the administration of Regenerons Products (such as Dupixent) and Regenerons Product Candidates in patients, including serious complications or side effects in connection with the use of Regenerons Products and Regenerons Product Candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict Regenerons ability to continue to develop or commercialize Regenerons Products and Regenerons Product Candidates, including without limitation Dupixent; ongoing regulatory obligations and oversight impacting Regenerons Products, research and clinical programs, and business, including those relating to patient privacy; the availability and extent of reimbursement of Regenerons Products from third-party payers, including private payer healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payers and new policies and procedures adopted by such payers; competing drugs and product candidates that may be superior to, or more cost effective than, Regenerons Products and Regenerons Product Candidates; the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators or licensees may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license, collaboration, or supply agreement, including Regenerons agreements with Sanofi, Bayer, and Teva Pharmaceutical Industries Ltd. (or their respective affiliated companies, as applicable) to be cancelled or terminated; and risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA (aflibercept) Injection, Dupixent, Praluent (alirocumab), and REGEN-COV (casirivimab and imdevimab)), other litigation and other proceedings and government investigations relating to the Company and/or its operations, the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regenerons business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regenerons filings with the U.S. Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2021. Any forward-looking statements are made based on managements current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise. Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regenerons media and investor relations website (http://newsroom.regeneron.com) and its Twitter feed (http://twitter.com/regeneron). Attachment Source: West Corporation Mar 18, 2022: Banco Santander Press Release: Sanofi moves forward with EUROAPI listing on Euronext Paris Sanofi moves forward with EUROAPI listing on Euronext Paris Sanofi will give its shareholders the opportunity to be part of EUROAPIs new chapter of growth through an additional extraordinary dividend in kindEUROAPI listing on Euronext Paris will occur in H1 2022, despite volatile market conditionsThe French State, through the fund French Tech Souverainete, intends to acquire 12% of EUROAPIs capital for up to 150 million from Sanofi to become a long-term reference shareholder of EUROAPIAs planned, Sanofi will continue to hold circa 30% of EUROAPI, post transaction The overall transaction is subject to approval at the Sanofi 2022 Shareholders Meeting, and the AMF approval on EUROAPIs French prospectus Paris, March 18 2022. Today marks a major milestone for EUROAPI, a leading European company dedicated to the development, production and marketing of active pharmaceutical ingredients* (API), as Sanofis Board of Directors unanimously proposed, on March 17th, to submit to its shareholders the distribution of circa 58% of the share capital of EUROAPI. In addition to the previously proposed 3.33 cash dividend per Sanofi share, this additional extraordinary dividend, exclusively in kind, is subject to shareholders approval at Sanofis May 3, 2022 Ordinary and Extraordinary Shareholders Meeting. If approved, the distribution will take place shortly after the listing of EUROAPIs shares on the regulated market of Euronext Paris, subject to the approval of the French Autorite des Marches Financiers (AMF) on EUROAPIs French prospectus, which will be made available to the public ahead of Sanofis Shareholders Meeting. Through this transaction, Sanofi is giving its shareholders the opportunity to take part in the success of a leading player in the API market with strong ambitions to become a global champion on a growing and dynamic market, and due to be listed on the regulated market of Euronext Paris. In connection with the proposed spin-off, French Tech Souverainete has agreed to purchase 12% in EUROAPI shares from Sanofi for up to 150 million, with the acquisition price to be determined based upon the thirty day volume weighted average trading price (VWAP) of EUROAPIs shares on Euronext Paris, starting on the first day of trading. As a result, French Tech Souverainete will become a long-term reference shareholder of EUROAPI and will be represented by two non-executive members on EUROAPI's Board of Directors, including Benjamin Paternot and another member to be determined. French Tech Souverainetes investment is subject to approval of the spin-off by Sanofis shareholders and other customary conditions. Post transaction, Sanofi confirms that it will hold circa 30% of the share capital and voting rights of EUROAPI and will remain a long-term strategic partner, supporting EUROAPIs growth ambitions as an independent company over the coming years. In addition to its highly diversified customer base of approximately 530 customers, EUROAPI benefits from a strong and long-term customer relationship with Sanofi, which represented nearly half of EUROAPIs revenues in 2021. In line with its Play to Win strategy aiming at simplifying its operations, Sanofi announced in February 2020 its ambition to create a new world leader in APIs to secure significant manufacturing and supply capacities that are critical for patients in Europe and beyond, in a context of increasing shortage of medicines essential to patient care. In 2021, Sanofi announced several critical steps in this journey with the unveiling of the creation of EUROAPI and the appointment of Karl Rotthier as its CEO in January, the appointment of Viviane Monges as Chair of the Supervisory Board in July and the finalization of the carve-out in December 2021. Despite volatile market conditions, Sanofi has decided to move forward with the listing process of EUROAPI. As an independent stand-alone company, EUROAPI will be able to fully unlock its growth potential, offering the best alignment of strategy, value creation and financial objectives for all of Sanofis shareholders. With a diversified technology portfolio, EUROAPI is positioned as the world's leading manufacturer of small molecule API (including complex chemical synthesis molecules, biochemical molecules from fermentation and highly potent molecules). It was the world's second largest manufacturer of APIs (including both small and large molecules such as peptides and oligonucleotides) in 2021 and number seven in the global CDMO (Contract Development and Manufacturing Organization) market in 20201. EUROAPI develops, manufactures, markets and distributes APIs and intermediates used in the formulation of medicines for human and veterinary use, both from originators and generics, through its API Solutions business and CDMO activities. Drawing on more than 150 years of experience in the growing API market, EUROAPI has a network of six production sites, all of which are located in Europe, and delivers around 200 APIs to approximately 530 customers in over 80 countries. The company will be able to rely on the expertise of around 3,350 employees and expects to achieve consolidated sales of around EUR 1 billion in the year ending December 31, 2022. Further details regarding the specifics of the distribution, including the parity, and the timetable of the spin-off will be set forth in EUROAPIs French prospectus. Following the AMFs approval of EUROAPIs French prospectus, Sanofi and EUROAPIs management teams will host a dedicated Capital Markets Day on April 1, 2022 at 1:30 pm CET to present EUROAPIs business in greater detail (event registration details are available here). *About Active Pharmaceutical Ingredients (APIs)Active Pharmaceutical Ingredients (APIs) are the chemical or biological substances in a medicine that have a therapeutic effect. They are the essential molecules used in the composition and manufacture of any medicine. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY About French Tech SouveraineteLaunched in June 2020 by the French government, French Tech Souverainete is an investment envelope managed by Bpifrance, with both proactive and defensive vocation. It already has a first pocket of 150M to support French technology companies developing future technologies of a sovereign nature, which may fall prey to large foreign players or be overtaken by competitors who are able to finance themselves better. Media RelationsSandrine Guendoul|+ 33 6 25 09 14 25 |sandrine.guendoul@sanofi.comNicolas Obrist|+ 33 6 77 21 27 55 |nicolas.obrist@sanofi.com Investor Relationsinvestor.relations@sanofi.com France:+ 33 1 53 77 45 45 |U.S.:+ 1 908 981 5560 Shareholders hotline Contact: + 33 805 29 21 06 NoticeThis press release does not constitute or form a part of any offer or solicitation to purchase or subscribe for securities in France, the United Kingdom, the United States of America, Canada, Australia, Japan or any other jurisdiction. No communication and no information in respect of the dividend distribution of the shares of EUROAPI (the Shares) may be sent to the public in any jurisdiction where a registration or approval is required. Any distribution of the Shares may be subject to specific legal or regulatory restrictions in certain jurisdictions. Neither Sanofi nor EUROAPI assumes any responsibility for any violation of any such restrictions by any person. Notice to holders of American Depositary Receipts (ADRs)Pursuant to the terms of the deposit agreement between JP Morgan, as Depositary, Sanofi and the owners and beneficial owners of American Depositary Receipts, as the Depositary deems the distribution of EUROAPI shares to ADS holders not to be feasible, the Depositary may adopt such method as it may reasonably deem equitable and practicable for the purpose of effecting the distribution of EUROAPI shares, including the sale of the EUROAPI shares and distribution of the net cash proceeds of the sale to ADR holders on the relevant record date. Sanofi Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words expects, anticipates, believes, intends, estimates, plans and similar expressions. Although Sanofis management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things Sanofis and EUROAPIs ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that COVID-19 and recent armed conflicts will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. Any material effect of COVID-19 or recent armed conflicts on any of the foregoing could also adversely impact us. This situation is changing rapidly and additional impacts may arise of which we are not currently aware and may exacerbate other previously identified risks. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under Risk Factors and Cautionary Statement Regarding Forward-Looking Statements in Sanofis annual report on Form 20-F for the year ended December 31, 2021. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. 1 Companys estimate based on third-party market research conducted using the annual reports published by the main industrial players in the APIs sector, public databases (including Capital IQ and Orbis) as well as interviews with market experts. Attachment Press Release Source: West Corporation Mar 16, 2022: Banco Santander Press Release: Sanofi and Seagen announce collaboration to develop and commercialize multiple novel antibody-drug conjugates Sanofi and Seagen announce collaboration to develop and commercialize multiple novel antibody-drug conjugates Jointly fund and develop up to three antibody-drug conjugate programs for the treatment of cancer Paris, March 16, 2022. Sanofi and Seagen Inc. (Nasdaq:SGEN) today announced an exclusive collaboration agreement to design, develop, and commercialize antibody-drug conjugates (ADCs) for up to three cancer targets. The collaboration will utilize Sanofis proprietary monoclonal antibody (mAb) technology and Seagens proprietary ADC technology. ADCs are antibodiesengineered to deliver potent anti-cancer drugsto tumor cells expressing a specific protein and Sanofi currently has one ADC in development. John Reed, M.D., Ph.D.Global Head of Research and Development, SanofiThis collaboration will enable the synergistic combination of molecules and platforms to produce candidate medicines with the potential of bringing renewed hope to cancer patients and their families.We look forward to joining forces with Seagen to collaboratively design and develop promising medicines by advancing antibody-drug conjugate science. Clay Siegall, Ph.D.President and Chief Executive Officer, SeagenWe are excited to be working with Sanofi, a global biopharmaceutical leader, to identify new ways to potentially address unmet medical needs of cancer patients. Jointly developing novel ADCs by combining antibodies from Sanofi with Seagens proprietary ADC technology, aligns with our strategic priorities to expand the global potential of our pipeline with new first- or best-in-class programs. Under the terms of the collaboration, Seagen and Sanofi will co-fund global development activities and share equally in any future profits. In addition, Sanofi will make an undisclosed payment to Seagen for each of the three targets as they are selected. The first target under the collaboration has already been designated. About SeagenSeagen is a global biotechnology company that discovers, develops and commercializes transformative cancer medicines to make a meaningful difference in peoples lives. Seagen is headquartered in the Seattle, Washington area, and has locations in California, Canada, Switzerland and the European Union. For more information on the companys marketed products and robust pipeline, visit www.seagen.com and follow @SeagenGlobal on Twitter. About Sanofi We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Sanofi Contacts Media RelationsSandrine Guendoul|+ 33 6 25 09 14 25 |sandrine.guendoul@sanofi.comSally Bain|+ 1 617 834 6026 |sally.bain@sanofi.com Investor RelationsEva Schaefer-Jansen|+ 33 7 86 80 56 39 |eva.schaefer-jansen@sanofi.comArnaud Delepine|+ 33 6 73 69 36 93 | arnaud.delepine@sanofi.comCorentine Driancourt|+ 33 6 40 56 92 21 | corentine.driancourt@sanofi.comFelix Lauscher|+ 1908612 7239 | felix.lauscher@sanofi.comPriya Nanduri| +1 908 981 5560 |priya.nanduri@sanofi.com Nathalie Pham|+ 33 7 85 93 30 17 | nathalie.pham@sanofi.com Seagen Contacts For InvestorsPeggy PinkstonSenior Vice President, Investor Relations(425) 527-4160ppinkston@seagen.com For MediaDavid CaouetteVice President, Corporate Communications(310) 430-3476dcaouette@seagen.com Seagen Forward-Looking Statements Certain of the statements made in this press release are forward looking, such as those relating to potential design, development and commercialization efforts, efforts to identify new ways to address unmet medical needs, and other statements that are not historical facts. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include the difficulty and uncertainty of pharmaceutical product development, the risk of adverse events or safety signals, the inability to show sufficient activity in clinical trials, the possibility of adverse regulatory actions and risk related to the COVID-19 pandemic. More information about the risks and uncertainties faced by Seagen is contained under the caption Risk Factors included in the Companys Annual Report on Form 10-K for the year ended December 31, 2021 filed with the Securities and Exchange Commission. Seagen disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. Sanofi Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words expects, anticipates, believes, intends, estimates, plans and similar expressions. Although Sanofis management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofis ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. Any material effect of COVID-19 on any of the foregoing could also adversely impact us. This situation is changing rapidly and additional impacts may arise of which we are not currently aware and may exacerbate other previously identified risks. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under Risk Factors and Cautionary Statement Regarding Forward-Looking Statements in Sanofis annual report on Form 20-F for the year ended December 31, 2021. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. Attachment Press_Release Source: West Corporation Mar 15, 2022: Banco Santander Sanofi announces 300 million collaboration with Blackstone Life Sciences to advance an innovative treatment for multiple myeloma Sanofi announces 300 million collaboration with Blackstone Life Sciences to advance an innovative treatment for multiple myeloma Investment will accelerate the overall Sarclisa development programSanofi will continue to fully manage the clinical program and retain full rights and control of Sarclisa (isatuximab) PARIS, March 15, 2022.Sanofi and Blackstone (NYSE: BX) today announced a strategic, risk-sharing collaboration under which funds managed by Blackstone Life Sciences (BXLS) will contribute up to 300 million to accelerate the global pivotal studies and the clinical development program for the subcutaneous formulation and delivery of the anti-CD38 antibody Sarclisa, to treat patients with multiple myeloma (MM). If successful, BXLS will be eligible to receive royalties on future subcutaneous sales. The pivotal study for the subcutaneous formulation is expected to begin in the second half of 2022. For the Sarclisa subcutaneous formulation delivery, Sanofi has partnered with drug delivery technology innovator company Enable Injections, Inc. to advance the development of a subcutaneous delivery for Sarclisa with the goal of offering a unique patient-centric treatment experience. To-date, Sarclisa has received regulatory approval for intravenous administration to treat certain patients with relapsed MM and is under investigation across the MM treatment continuum of care for other hematologic malignancies and solid tumors. John Reed, MD, Ph.D.Global Head of Research and Development for SanofiThe collaboration with Blackstone will accelerate our ability to offer patients a subcutaneous anti-CD38 antibody therapy that we believe will be innovative and more convenient. We are committed to building an industry-leading, sustainable pipeline with a steady stream of new therapies that have the potential to transform the practice of medicine. Nicholas Galakatos, Ph.D.Global Head of Blackstone Life SciencesWe are excited to collaborate with Sanofi's experienced development team to advance a subcutaneous dosage form for Sarclisa for patients. Our investment demonstrates Blackstones commitment and ability to provide innovative sources of financing to the worlds leading pharmaceutical companies as we offer capital at scale and complementary expertise to help advance important medicines in critical therapeutic areas. Sanofi has considerable expertise in oncology and has increased research and development capabilities, focusing on difficult to treat cancers, including breast, blood, and lung. Additional terms of the collaboration were not disclosed. About Sarclisa Sarclisa is a monoclonal antibody that targets a specific epitope on the CD38 receptor on MM cells. It is designed to work through multiple mechanisms of action including programmed tumor cell death (apoptosis) and immunomodulatory activity. CD38 is highly and uniformly expressed on the surface of MM cells, making it a potential target for antibody-based therapeutics such as Sarclisa. Based on the Phase 3 ICARIA-MM study, Sarclisa is approved in a number of countries in combination with pomalidomide and dexamethasone for the treatment of patients with relapsed refractory MM (RRMM) who have received 2 prior therapies, including lenalidomide and a proteasome inhibitor. Based on the Phase 3 IKEMA study, Sarclisa is also approved in combination with carfilzomib and dexamethasone in the U.S. for the treatment of patients with RRMM who have received 13 prior lines of therapy and in the European Union for patients with MM who have received at least 1 prior therapy. In the U.S., the generic name for Sarclisa is isatuximab-irfc, with irfc as the suffix designated in accordance with Nonproprietary Naming of Biological Products Guidance for Industry issued by the U.S. Food and Drug Administration (FDA). Sarclisa continues to be evaluated in multiple ongoing Phase 3 clinical trials in combination with current standard treatments across the MM treatment continuum. It is also under investigation for the treatment of other hematologic malignancies and solid tumors. The safety and efficacy of these additional uses have not been reviewed by any regulatory authority worldwide. For more information on Sarclisa clinical trials, please visit www.clinicaltrials.gov. About Multiple Myeloma Multiple myeloma (MM) is the second most common hematologic malignancy,1 with more than 130,000 new global annual diagnoses2. Despite available treatments, MM remains an incurable malignancy and is associated with significant patient burden. Since MM does not have a cure, most patients will relapse. Relapsed MM is the term for when the cancer returns after treatment or a period of remission. Refractory MM refers to when the cancer does not respond or no longer responds to therapy. About Blackstone Life Sciences Blackstone Life Sciences is an industry-leading private investment platform with capabilities to invest across the life cycle of companies and products within the key life science sectors. By combining scale investments and hands-on operational leadership, Blackstone Life Sciences helps bring to market promising new medicines and medical technologies that improve patients lives. More information is provided at https://www.blackstone.com/our-businesses/life-sciences/. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Sanofi Media RelationsSandrine Guendoul|+ 33 6 25 09 14 25 |sandrine.guendoul@sanofi.comSally Bain|+ 1 617 834 6026 |sally.bain@sanofi.comKate Conway|+ 1508364 4931 |kate.conway@sanofi.com Sanofi Investor RelationsEva Schaefer-Jansen|+ 33 7 86 80 56 39 |eva.schaefer-jansen@sanofi.comArnaud Delepine|+ 33 6 73 69 36 93 | arnaud.delepine@sanofi.comCorentine Driancourt|+ 33 6 40 56 92 21 | corentine.driancourt@sanofi.comFelix Lauscher|+ 1908612 7239 | felix.lauscher@sanofi.comPriya Nanduri|priya.nanduri@sanofi.com Nathalie Pham|+ 33 7 85 93 30 17 | nathalie.pham@sanofi.com Blackstone Media RelationsUnited States: Paula Chirhart | +1 347 463 5453 | paula.chirhart@blackstone.com Sanofi Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words expects, anticipates, believes, intends, estimates, plans and similar expressions. Although Sanofis management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofis ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. Any material effect of COVID-19 on any of the foregoing could also adversely impact us. This situation is changing rapidly and additional impacts may arise of which we are not currently aware and may exacerbate other previously identified risks. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under Risk Factors and Cautionary Statement Regarding Forward-Looking Statements in Sanofis annual report on Form 20-F for the year ended December 31, 2021. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. 1 Kazandjian. Multiple myeloma epidemiology and survival: A unique malignancy.Semin Oncol.2016;43(6):676-681. doi:10.1053/j/seminoncol.2016.11.004.2 International Myeloma Foundation. Myeloma Action Month.https://mam.myeloma.org/learn-more-about-multiple-myeloma/. Accessed December 2021. Attachment Source: West Corporation Mar 14, 2022: Banco Santander Sanofi provides update on Phase 2 study evaluating amcenestrant in ER+/HER2- advanced or metastatic breast cancer Sanofi provides update on Phase 2 study evaluating amcenestrant in ER+/HER2- advanced or metastatic breast cancer AMEERA-3 trial did not meet primary endpoint of improving progression-free survivalOngoing trials continue as planned, including AMEERA-5 and AMEERA-6 Paris, March 14, 2022. The Phase 2 AMEERA-3 clinical trial evaluating amcenestrant, an investigational optimized oral selective estrogen receptor degrader (SERD), did not meet its primary endpoint of improving progression-free survival (PFS) as assessed by an independent central review. The trial evaluated amcenestrant as monotherapy compared to endocrine treatment of physicians choice in patients with locally advanced or metastatic estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-) breast cancer who progressed on or after hormonal therapies. No new safety signals were identified and the safety profile of amcenestrant in AMEERA-3 was consistent with earlier studies. John Reed, MD, PhDHead of Research and Development at SanofiThis Phase 2 trial evaluated amcenestrant as a monotherapy in a patient population with advanced disease where limited treatment options remain. While we are disappointed with the AMEERA-3 results, we continue to investigate amcenestrant in patients with earlier stages of breast cancer with different tumor profiles and where different standard of care treatments are used. Sanofi will continue to assess data from the AMEERA-3 trial and work with investigators on the publication of the full results. The ongoing clinical trial program for amcenestrant continues as planned, including AMEERA-5 and AMEERA-6. Amcenestrant is an optimized oral SERD that binds to the estrogen receptors (ER) in breast cancer cells to inhibit their normal function and trigger degradation so they can no longer be used by tumor cells to grow. Amcenestrant is currently under clinical investigation and its safety and efficacy have not been evaluated by any regulatory authority. About the AMEERA-3 trial AMEERA-3 was an open-label, Phase 2 randomized trial evaluating the efficacy and safety of amcenestrant as a monotherapy compared to single-agent endocrine treatment of the physicians choice in patients with ER+, HER2- locally advanced or metastatic breast cancer with prior exposure to hormonal therapies. The primary objective of AMEERA-3 was to determine whether amcenestrant improved PFS assessed by an independent central review compared to endocrine monotherapy. The key secondary efficacy endpoint was overall survival and other secondary endpoints were objective response rate, disease control rate, clinical benefit rate and duration of response. The study also compared the overall safety profile in the two treatment arms and evaluated health-related quality of life in the two treatment arms based on patient-reported outcomes. About the amcenestrant clinical program The comprehensive development program for amcenestrant has been designed to evaluate its potential as an oral endocrine backbone therapy across treatment lines, including: as a single agent in second-line or later lines of treatment of ER+/HER2- metastatic breast cancer (MBC) (AMEERA-3), in combination with palbociclib in the first-line treatment of ER+/HER2- MBC (AMEERA-5), and to explore its potential in early-stage breast cancer patients in the adjuvant setting (AMEERA-6). Initiated in late 2020, the Phase 3 AMEERA-5 clinical trial is now fully enrolled. The Phase 3 AMEERA-6 trial, in partnership with the Breast International Group (BIG), the European Organization for Research and Treatment of Cancer (EORTC), and the Alliance Foundation Trials (AFT) is now enrolling. For more information on amcenestrant clinical trials, please visit www.clinicaltrials.gov. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Media RelationsSally Bain|+ 1 617 834 6026 |sally.bain@sanofi.comSandrine Guendoul|+ 33 6 25 09 14 25 |sandrine.guendoul@sanofi.com Investor RelationsEva Schaefer-Jansen|+ 33 7 86 80 56 39 |eva.schaefer-jansen@sanofi.comArnaud Delepine|+ 33 6 73 69 36 93 | arnaud.delepine@sanofi.comCorentine Driancourt|+ 33 6 40 56 92 21 | corentine.driancourt@sanofi.comFelix Lauscher|+ 1908612 7239 | felix.lauscher@sanofi.comPriya Nanduri|+1 908 981 5560 | priya.nanduri@sanofi.com Nathalie Pham|+ 33 7 85 93 30 17 | nathalie.pham@sanofi.com Disclaimers or Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words expects, anticipates, believes, intends, estimates, plans and similar expressions. Although Sanofis management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofis ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. Any material effect of COVID-19 on any of the foregoing could also adversely impact us. This situation is changing rapidly and additional impacts may arise of which we are not currently aware and may exacerbate other previously identified risks. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under Risk Factors and Cautionary Statement Regarding Forward-Looking Statements in Sanofis annual report on Form 20-F for the year ended December 31, 2021. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. Attachment Source: West Corporation Mar 09, 2022: Banco Santander Efanesoctocog alfa met primary and key secondary endpoints in pivotal study in hemophilia A, demonstrating superiority to prior factor prophylaxis treatment Efanesoctocog alfa met primary and key secondary endpoints in pivotal study in hemophilia A, demonstrating superiority to prior factor prophylaxis treatment Once-weekly efanesoctocog alfa met primary endpoint in phase 3 study, resulting in a clinically meaningful prevention of bleeding episodes (bleed protection) In the key secondary endpoint, efanesoctocog alfa demonstrated superiority in prevention of bleeding episodes, showing a statistically significant and clinically meaningful reduction in annualized bleeding rate compared to prior factor VIII prophylaxis therapyEfanesoctocog alfa is a novel and investigational factor VIII therapy designed to provide near-normal factor activity levels for the majority of the week in a once-weekly prophylactic treatment regimen Paris and Stockholm March 9, 2022 - Sanofi and Swedish Orphan Biovitrum AB (publ) (Sobi) (STO:SOBI) today announced positive topline results from the pivotal XTEND-1 Phase 3 study evaluating the safety, efficacy and pharmacokinetics of efanesoctocog alfa (BIVV001) in previously treated patients 12 years of age with severe hemophilia A. The study met the primary endpoint, showing a clinically meaningful prevention of bleeds in people with severe hemophilia A receiving weekly prophylaxis with efanesoctocog alfa over a period of 52 weeks. The median annualized bleeding rate (ABR) was 0 with a mean ABR of 0.71. The key secondary endpoint was also met, demonstrating once-weekly efanesoctocog alfa was superior to prior prophylactic factor VIII replacement therapy, showing a statistically significant reduction in ABR based on intra-patient comparison. Efanesoctocog alfa was well-tolerated, and inhibitor development to factor VIII was not detected. The most common treatment-emergent adverse events (>5% of participants overall) were headache, arthralgia, fall, and back pain. Dietmar Berger, MD, PhD Global Head of Development and Chief Medical Officer, SanofiWhile advances have been made in the treatment of hemophilia, unmet medical needs still exist. These positive topline data, showing a very low annualized bleeding rate, enhance efanesoctocog alfas potential to transform hemophilia A therapy. We believe efanesoctocog alfa provides higher protection for longer duration with reduced treatment burden of once-weekly dosing, and we look forward to working with regulators to bring this therapy to patients as soon as possible. Hemophilia A is a rare, genetic disorder in which the ability of a persons blood to clot is impaired due to a lack of factor VIII. Hemophilia A occurs in about one in 5,000 male births annually, and more rarely in females. People with hemophilia can experience bleeding episodes that can cause pain, irreversible joint damage and life-threatening hemorrhages. Anders Ullman, MD, PhDHead of R&D and Chief Medical Officer, SobiWe believe once-weekly efanesoctocog alfa has the potential to represent a new class of factor VIII therapy designed to provide high sustained factor VIII levels near normal for the majority of the week. We look forward to sharing these Phase 3 results, including data on physical health, pain and joint health, at future medical meetings. The data will be the basis for submission to regulatory authorities around the globe beginning this year. Submission in the EU will follow availability of data from the ongoing XTEND-Kids pediatric study, expected in 2023. Efanesoctocog alfa was granted Orphan Drug Designation by the US Food and Drug Administration (FDA) in August 2017 and the European Commission in June 2019. The US FDA granted Fast Track Designation in February 2021. Efanesoctocog alfa is currently under clinical investigation and its safety and efficacy have not been evaluated by any regulatory authority. About Phase 3 XTEND-1 studyThe Phase 3 XTEND-1 study (NCT04161495) is an open-label, non-randomized interventional study assessing the safety, efficacy and pharmacokinetics of efanesoctocog alfa in people 12 years of age or older (n=159) with severe hemophilia A who were previously treated with factor VIII replacement therapy. The study includes two parallel treatment arms the prophylaxis arm, where study participants received a weekly prophylactic 50 IU/kg dose of efanesoctocog alfa for 52 weeks (Arm A), some of which were enrolled following an observation period on prophylaxis using currently marketed factor VIII replacement therapies, and an on-demand arm, where study participants received 50 IU/kg as needed for 26 weeks followed by weekly prophylaxis for another 26 weeks (Arm B). The primary efficacy endpoint was the annualized bleeding rate (ABR) in Arm A, and the key secondary endpoint was an intra-patient comparison of ABR during the efanesoctocog alfa weekly prophylaxis treatment period versus the prior prophylaxis ABR for participants in Arm A who participated in Study 242HA201/OBS16221, an observational study. About efanesoctocog alfa (BIVV001)Efanesoctocog alfa is a novel and investigational recombinant factor VIII therapy that is designed to extend protection from bleeds with once-weekly prophylactic dosing for people with hemophilia A. It builds on the innovative Fc fusion technology by adding a region of von Willebrand factor and XTEN polypeptides to extend its time in circulation. It is the first investigational factor VIII therapy that has been shown to break through the von Willebrand factor ceiling, which imposes a half-life limitation on current factor VIII therapies. Efanesoctocog alfa is currently under clinical investigation and its safety and efficacy have not been evaluated by any regulatory authority. About the Sanofi and Sobi collaborationSobi and Sanofi collaborate on the development and commercialization of Alprolix and Elocta/Eloctate. The companies also collaborate on the development and commercialization of efanesoctocog alfa, an investigational factor VIII therapy with the potential to provide high sustained factor activity levels with once-weekly dosing for people with hemophilia A. Sobi has final development and commercialization rights in the Sobi territory (essentially Europe, North Africa, Russia and most Middle Eastern markets). Sanofi has final development and commercialization rights in North America and all other regions in the world excluding the Sobi territory. SobiSobi is a specialised international biopharmaceutical company transforming the lives of people with rare diseases. Providing sustainable access to innovative medicines in the areas of haematology, immunology and specialty care, Sobi has approximately 1,600 employees across Europe, North America, the Middle East and Asia. In 2021, revenue amounted to SEK 15.5 billion. Sobis share (STO:SOBI) is listed on Nasdaq Stockholm. More about Sobi at sobi.com, LinkedIn and YouTube. XTEN is a registered trademark of Amunix Pharmaceuticals, Inc. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Sanofi:Media RelationsSandrine Guendoul|+ 33 6 25 09 14 25 |sandrine.guendoul@sanofi.comSally Bain|+ 1 617 834 6026 |sally.bain@sanofi.com Investor RelationsEva Schaefer-Jansen|+ 33 7 86 80 56 39 |eva.schaefer-jansen@sanofi.comArnaud Delepine|+ 33 6 73 69 36 93 | arnaud.delepine@sanofi.comCorentine Driancourt|+ 33 6 40 56 92 21 | corentine.driancourt@sanofi.comFelix Lauscher|+ 1908612 7239 | felix.lauscher@sanofi.comPriya Nanduri|+1 908 981 5560 | priya.nanduri@sanofi.com Nathalie Pham|+ 33 7 85 93 30 17 | nathalie.pham@sanofi.com Sobi:For details on how to contact the Sobi Investor Relations Team, click here. For Sobi Media contacts, click here. Thomas Kudsk Larsen | Head of Communication and Investor RelationsPaula Treutiger | Global Head of Communication Sanofi Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words expects, anticipates, believes, intends, estimates, plans and similar expressions. Although Sanofis management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofis ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. Any material effect of COVID-19 on any of the foregoing could also adversely impact us. This situation is changing rapidly and additional impacts may arise of which we are not currently aware and may exacerbate other previously identified risks. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under Risk Factors and Cautionary Statement Regarding Forward-Looking Statements in Sanofis annual report on Form 20-F for the year ended December 31, 2021. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. Attachment Source: West Corporation Mar 08, 2022: Banco Santander Sanofi recognized by S&P as one of the most sustainability-committed companies Sanofi recognized by S&P as one of the most sustainability-committed companies Paris, March 8, 2022. Sanofi was today recognized as one of the most sustainability-committed companies in an ESG Evaluation (Environment, Social, Governance) performed by Standard & Poors Global Ratings (S&P). The ESG Evaluation awarded Sanofi a score of 86 out of 100 points, one of the highest scores across all sectors globally. Sanofis ESG profile was awarded 80 points for its solid fundamentals, completed with an additional strong preparedness opinion of 6 points awarded for its excellent awareness of risks and opportunities and its capacity to anticipate and adapt to a variety of long-term plausible disruptions. Sanofi's Social Profile was ranked as leading in the category of communities highlighting the recent 2021 creation of its global health unit which aims to provide 30 of Sanofi's medicines across a wide range of therapeutic areas to patients in 40 of the lowest income countries. The report also noted Sanofis commitment to eliminating infectious disease such as polio, sleeping sickness and malaria. Sanofi is the first large biopharmaceutical company evaluated by a S&P Global Ratings ESG Evaluation and was notably distinguished for its commitment to access to medicines, particularly in vulnerable communities. The study, which recognized the increasing challenges and inequalities in healthcare across all geographies, identified the creation of a nonprofit unit dedicated to provide poorest countries with access to essential medicines as one of Sanofi's leading differentiators. Sandrine Bouttier-StrefGlobal Head of Corporate Social Responsibility of SanofiWe are pleased that S&Ps Global Ratings ranked us among the topmost sustainable companies. The results of the ESG Evaluation is true recognition for the accomplishments that our team has achieved since launching our renewed commitment to society in 2021. We are particularly proud that our newly formed Global Health Unit, which reflects our commitment to society and vulnerable populations, has been named as a leading differentiator by S&P Global Ratings ESG evaluators. Standard & Poors Global RatingsESG EvaluationThe ESG Evaluation reflects our assessment of Sanofi's innovation capacity, which we think will help drive the industry forward, as well as the concrete steps it has already taken in implementing its strategy. Embedded into the companys Play to Win strategy, Sanofis social impact strategy is based on four essential pillars in which Sanofi is uniquely positioned to make a difference: (1) global access & affordability to health while helping healthcare systems' sustainability including educational programs, (2) Innovation for the most vulnerable populations (3) Ensuring patients access to medicines while reconnecting health with the planet (4) Building an inclusive workplace while engaging with communities. The continuous implementation of Sanofis social impact strategy has led in recent months to a range of positive updates of the companys rank or grade in most of the ESG rankings. Sanofi communicates on a quarterly basis on the progress on implementation of its social impact strategy with a dedicated section in the earnings press release. About the ESG EvaluationS&P Global Ratings' ESG Evaluation is a cross-sector, relative analysis of an entity's capacity tocontinue to operate successfully. It is grounded in how ESG factors could affect stakeholders,potentially leading to a material direct or indirect financial impact on the entity.First, an ESG profile is established for a given entity, which assesses the exposure of the entity'soperations to observable ESG risks and opportunities, and how the entity is mitigating these risks and capitalizing on these opportunities.Second, the entity's long-term preparedness is assessed, namely its capacity to anticipate andadapt to a variety of long-term plausible disruptions. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Media RelationsSally Bain|+ 1 617 834 6026 |sally.bain@sanofi.comNicolas Obrist|+ 33 6 77 21 27 55 |nicolas.obrist@sanofi.comVictor Rouault|+ 33 6 70 93 71 40 |victor.rouault@sanofi.com Investor RelationsEva Schaefer-Jansen|+ 33 7 86 80 56 39 |eva.schaefer-jansen@sanofi.comArnaud Delepine|+ 33 6 73 69 36 93 | arnaud.delepine@sanofi.comCorentine Driancourt|+ 33 6 40 56 92 21 | corentine.driancourt@sanofi.comFelix Lauscher|+ 1908612 7239 | felix.lauscher@sanofi.comPriya Nanduri| +1 908 981 5560 |priya.nanduri@sanofi.com Nathalie Pham|+ 33 7 85 93 30 17 | nathalie.pham@sanofi.com Sanofi Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words expects, anticipates, believes, intends, estimates, plans and similar expressions. Although Sanofis management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofis ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. Any material effect of COVID-19 on any of the foregoing could also adversely impact us. This situation is changing rapidly and additional impacts may arise of which we are not currently aware and may exacerbate other previously identified risks. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under Risk Factors and Cautionary Statement Regarding Forward-Looking Statements in Sanofis annual report on Form 20-F for the year ended December 31, 2021. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. Attachment Source: West Corporation Mar 03, 2022: Banco Santander Nirsevimab significantly protected infants against RSV disease in Phase 3 trial Nirsevimab significantly protected infants against RSV disease in Phase 3 trial Nirsevimab showed a 74.5% reduction in lower respiratory tract infections caused by RSV requiring medical care in healthy infants1,2Nirsevimab is the first investigational immunization designed to protect all infants across the RSV season with a single dosePivotal Phase 3 results published in The New England Journal of Medicine Paris, March 3, 2022. The New England Journal of Medicine (NEJM) today published detailed results from a Phase 3 trial evaluating nirsevimab, the first investigational long-acting antibody designed to protect all infants across the respiratory syncytial virus (RSV) season with a single dose. The trial involved healthy infants born at term or late preterm (35 weeks gestational age or greater) entering their first RSV season and met the primary endpoint, reducing the incidence of medically attended lower respiratory tract infections (LRTI), such as bronchiolitis or pneumonia, caused by RSV by 74.5% (95% CI 49.6 to 87.1; P<0.001) compared to placebo.1,2A prespecified pooled analysis of RSV-associated hospitalizations in both the Phase 3 and Phase 2b trials was also conducted. In term and preterm infants (greater than 28 weeks gestational age), the proposed dose of nirsevimab demonstrated efficacy of 77.3% (95% CI 50.3 to 89.7; P<0.001) against RSV-associated hospitalizations.1-3 In the Phase 3 MELODY trial alone, a numerical reduction of the risk of RSV-associated hospitalizations was observed, although not statistically significant (62.1%, 95% CI: -8.6 to 86.8; P=0.07).1,2 In the nirsevimab arm, six of 994 infants were hospitalized for RSV LRTI, while eight of 496 infants were hospitalized in the placebo arm.1,2 Nirsevimab is being developed by Sanofi and AstraZeneca. Dr. William MullerAssociate Professor, Pediatrics, Northwestern University Feinberg School of Medicine and Scientific Director, Clinical and Community Trials, Ann & Robert H. Lurie Childrens Hospital of Chicago, IllinoisWe know that RSV has seen a resurgence with the easing of COVID-19 public health measures. This shows us a broad immunization approach is needed to help mitigate the substantial global burden RSV places on infants, their families and healthcare services. These exciting data show that nirsevimab has the potential to offer RSV protection for all infants, which would be a paradigm shift in the approach to this disease. The results of the Phase 3 and Phase 2/3 clinical trials, combined with the Phase 2b trial and conducted in different trial populations, demonstrate nirsevimabs potential to protect all infants across the RSV season with a single dose.1-6 Jean-Francois ToussaintGlobal Head of Research and Development Vaccines, Sanofi With three pivotal late-stage trials, our research has been focused on delivering a first-in-class RSV prevention for all infants. Our Phase 3 MELODY results in healthy late preterm and term infants represent a major milestone toward that goal. We are pleased nirsevimab has the potential to become the first immunization to protect all infants across the RSV season, with only a single dose. Potential to provide rapid protection Nirsevimab is the first investigational long-acting antibody designed to protect all infants during their first RSV season. With nirsevimab, the goal is to provide rapid and direct protection to the infant through a single immunization. It is the first potential immunization to show protection against RSV in infants in a Phase 3 trial.1,2 RSV is the most common cause of LRTI, including bronchiolitis and pneumonia, and a leading cause of hospitalizations in all infants.7-9 Mene PangalosExecutive Vice President, BioPharmaceuticals R&D, AstraZenecaRespiratory syncytial virus is a leading cause of lower respiratory tract infections, such as bronchiolitis or pneumonia, as well as hospitalizations in infants. These data show for the first time, the potential to significantly protect all infants through their first RSV season with a single-dose immunization and we look forward to working with health authorities to bring nirsevimab to infants as quickly as possible. The safety and tolerability of nirsevimab compared to palivizumab was evaluated in the Phase 2/3 trial, which demonstrated nirsevimab had a similar safety and tolerability profile compared to palivizumab when administered to infants with congenital heart disease, chronic lung disease and prematurity (35 weeks gestational age or fewer) entering their first RSV season.5,6 Safety was assessed by monitoring the occurrence of all treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) through 360 days post-dose. The serum levels of nirsevimab following dosing at Day 151 in this trial were comparable with those observed in the Phase 3 trial, indicating similar protection in this population to that in the healthy term and late preterm infants is likely.1,2,5,6 Details from the Phase 2/3 trial were also published in NEJM. The study is ongoing, and topline results were presented at RSVVW21. Regulatory submissions have begun in the first half of 2022. About the Phase 3 trial MELODY is a randomized, placebo-controlled Phase 3 trial conducted across 21 countries designed to determine the incidence of medically attended LRTI due to RSV confirmed by reverse transcriptase polymerase chain reaction testing through 150 days after dosing, versus placebo, in healthy infants entering their first RSV season.1,2 Healthy late preterm and term infants (35 weeks gestational age or greater) were randomized (2:1) to receive a single 50mg (in infants weighing <5kg) or 100mg (in infants weighing 5kg) intramuscular injection of nirsevimab or placebo. Between July 2019 and February 2021, 1,490 infants were randomized to either nirsevimab or placebo at the RSV season start.1,2 Pooled analyses of the RSV LRTI hospitalization endpoint from both of the MELODY and the Phase 2b trials were prespecified under a multiplicity-protected hierarchical testing strategy. The overall safety profile of nirsevimab in the trial remains consistent with previously reported results. No clinically meaningful differences in safety results between the nirsevimab and placebo groups were seen in MELODY and Phase 2b.1-4 The evaluation of the primary endpoint in the MELODY trial was conducted earlier than anticipated. Global public health measures to control COVID-19 had reduced the circulation of all respiratory viruses, including RSV, at the time of trial enrollment. Sufficient cases had been accrued prior to the pandemic to evaluate nirsevimabs ability to prevent RSV LRTI versus placebo. An additional 1,500 infants have been enrolled in the Northern and Southern Hemispheres to provide additional safety information.1,2 About the Phase 2/3 trial MEDLEY is a Phase 2/3, randomized, double-blind, palivizumab-controlled trial with the primary objective of assessing safety and tolerability for nirsevimab in preterm infants and infants with congenital heart disease (CHD) and/or chronic lung disease of prematurity (CLD) eligible to receive palivizumab.5,6 Between July 2019 and May 2021, approximately 918 infants entering their first RSV season were dosed with either nirsevimab or palivizumab. Safety is assessed by monitoring the occurrence of TEAEs and TESAEs through 360 days post-dose.5,6 The evaluation of the safety and tolerability of nirsevimab in the MEDLEY trial was carried out earlier than anticipated. A primary analysis was conducted to allow earlier assessment of nirsevimabs safety and tolerability versus palivizumab based on a sufficient number of infants being enrolled and followed through their first RSV season. The results of MEDLEY, MELODY, and the Phase 2b trial demonstrate that nirsevimab provides protection against RSV in all infants with a single dose.1-6 This all-infant population includes preterm, healthy late preterm and term infants, as well as infants with CLD and CHD. These trials form the basis of regulatory submissions that have begun in first half of 2022. About RSV RSV is a common, contagious virus that causes seasonal epidemics of lower respiratory tract infections (LRTI), leading to bronchiolitis and pneumonia in infants.10-12 It is also a leading cause of hospitalizations in all infants.8,9 Globally, in 2015, there were approximately 30 million cases of acute lower respiratory infections leading to more than three million hospitalizations, and it was estimated that there were 60,000 in-hospital deaths of children younger than five years.12,13 In recent months, there has been a resurgence of RSV following the easing of COVID-19 public health measures.14,15 Most hospitalizations for RSV occur in otherwise healthy infants born at term.16,17 Medically attended LRTIs are associated with increased costs to the healthcare system.18 About nirsevimab Nirsevimab is an investigational long-acting antibody designed to protect all infants through their first RSV season with a single dose. Due to its extended half-life technology, nirsevimab is being developed as a single dose for all infants experiencing their first RSV season and infants with specific conditions, such as congenital heart disease or chronic lung disease, entering their first and second RSV season.2,6,19 Nirsevimab is an immunization designed to provide direct prophylactic RSV protection to all infants via an antibody to help prevent LRTI caused by RSV. Monoclonal antibodies do not require the activation of the immune system to help offer rapid and direct protection against disease.20 In March 2017, Sanofi and AstraZeneca announced an agreement to develop and commercialize nirsevimab. Under the terms of the agreement, AstraZeneca leads all development and manufacturing activities and Sanofi will lead commercialization activities and record revenues. Under the terms of the global agreement, Sanofi made an upfront payment of 120m, has paid a development milestone of 30m and will pay up to a further 465m upon achievement of certain development and sales-related milestones. The two companies share all costs and profits. Revenue from the agreement is reported as Collaboration Revenue in the Companys financial statements. Nirsevimab has been granted regulatory designations to facilitate expedited development by several regulatory agencies around the world. These include Breakthrough Therapy Designation by The China Center for Drug Evaluation under the National Medical Products Administration; Breakthrough Therapy Designation from the US Food and Drug Administration; access granted to the European Medicines Agency PRIority MEdicines scheme; Promising Innovative Medicine designation by the UK Medicines and Healthcare products Regulatory Agency; and named a medicine for prioritized development under the Project for Drug Selection to Promote New Drug Development in Pediatrics by the Japan Agency for Medical Research and Development (AMED). Nirsevimab is currently under clinical investigation and its safety and efficacy have not been reviewed by any regulatory authority. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Media RelationsSandrine Guendoul|+ 33 6 25 09 14 25 |sandrine.guendoul@sanofi.comSally Bain|+ 1 617 834 6026 |sally.bain@sanofi.comChrystel Baude|+ 33 6 70 98 70 59 |chrystel.baude@sanofi.comNicolas Obrist|+ 33 6 77 21 27 55 |nicolas.obrist@sanofi.comVictor Rouault|+ 33 6 70 93 71 40 |victor.rouault@sanofi.comKate Conway|+ 1508364 4931 |kate.conway@sanofi.com Investor RelationsEva Schaefer-Jansen|+ 33 7 86 80 56 39 |eva.schaefer-jansen@sanofi.comArnaud Delepine|+ 33 6 73 69 36 93 | arnaud.delepine@sanofi.comCorentine Driancourt|+ 33 6 40 56 92 21 | corentine.driancourt@sanofi.comFelix Lauscher|+ 1908612 7239 | felix.lauscher@sanofi.comPriya Nanduri|priya.nanduri@sanofi.com Nathalie Pham|+ 33 7 85 93 30 17 | nathalie.pham@sanofi.com Sanofi Forward-Looking Statements This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words expects, anticipates, believes, intends, estimates, plans and similar expressions. Although Sanofis management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofis ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. Any material effect of COVID-19 on any of the foregoing could also adversely impact us. This situation is changing rapidly and additional impacts may arise of which we are not currently aware and may exacerbate other previously identified risks. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under Risk Factors and Cautionary Statement Regarding Forward-Looking Statements in Sanofis annual report on Form 20-F for the year ended December 31, 2021. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. 1.Hammitt LL, MD et al. Nirsevimab for Prevention of RSV in Healthy Late -Preterm and Term Infants. N Engl J Med. 2022;386 (9): 837-846. doi: 10.1056/NEJMoa21102752.Clinicaltrials.gov. A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended RSV LRTI in Healthy Late Preterm and Term Infants (MELODY). https://clinicaltrials.gov/ct2/show/NCT03979313. Accessed March 2022.3.Clinicaltrials.gov. A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended RSV LRTI in Healthy Preterm Infants. (MEDI8897 Ph2b).https://clinicaltrials.gov/ct2/show/results/NCT02878330. Accessed March 2022.4.Griffin P, MD et al. (2020). Single-Dose Nirsevimab for Prevention of RSV in Preterm Infants. NEJM 2020; 383: 415-425. DOI: 10.1056/NEJMoa1913556. Accessed March 2022.5.Domachowske J, MD et al. Safety of Nirsevimab for RSV in Infants with Heart or Lung Disease or Prematurity. N Engl J Med. 2022; 386 (9). 6.Clinicaltrials.gov. A Study to Evaluate the Safety of MEDI8897 for the Prevention of Medically Attended Respiratory Syncytial Virus (RSV) Lower Respiratory Track Infection (LRTI) in High-risk Children. https://clinicaltrials.gov/ct2/show/NCT03959488.Accessed March 2022.7.R K. Respiratory Syncytial Virus Vaccines. Plotkin SA, Orenstein WA, Offitt PA, Edwards KM, eds Plotkins Vaccines 7th ed Philadelphia. 2018;7th ed. Philadelphia:943-9.8.Leader S, Kohlhase K. Respiratory syncytial virus-coded pediatric hospitalizations, 1997 to 1999. The Pediatric infectious disease journal. 2002;21(7):629-32.9.McLaurin KK, Farr AM, Wade SW, Diakun DR, Stewart DL. Respiratory syncytial virus hospitalization outcomes and costs of full-term and preterm infants. Journal of Perinatology: official journal of the California Perinatal Association. 2016;36(11):990-6.10.Piedimonte G, Perez MK. Respiratory syncytial virus infection and bronchiolitis. Pediatr Rev. 2014;35:519-53.11.Oymar K, et al. Acute bronchiolitis in infants, a review. Scand J Trauma Resusc Emerg Med. 2014;22:23.12.Shi T, et al. Global, regional, and national disease burden estimates of acute lower respiratory infections due to respiratory syncytial virus in young children in 2015: a systematic review and modelling study. Lancet 2017; 390: 94658.13.Oxford Vaccines Group. What is RSV? https://vk.ovg.ox.ac.uk/vk/rsv. Accessed March 2022. 14.Ujiie M, Tsuzuki S, Nakamoto T, et al. Resurgence of Respiratory Syncytial Virus Infections during COVID-19 Pandemic, Tokyo, Japan. Emerging Infectious Diseases. 2021;27(11):2969-2970. doi:10.3201/eid2711.211565. 15.CDC Health Alert Network. Increased Interseasonal Respiratory Syncytial Virus (RSV) Activity in Parts of the Southern United States. Centers for Disease Control and Prevention. June 10 2021. https://emergency.cdc.gov/han/2021/han00443.asp Accessed March 2022. 16.Rha B et al. Respiratory Syncytial VirusAssociated Hospitalizations Among Young Children: 20152016. Pediatrics. 2020;146(1):e20193611. 17.Arriola CS, Kim L, Langley G, Anderson EJ, Openo K, Martin AM, et al. Estimated Burden of Community-Onset Respiratory Syncytial Virus-Associated Hospitalizations Among Children Aged <2 Years in the United States, 2014-15. Journal of the Pediatric Infectious Diseases Society. 2020;9(5):587-95. 18.Leistner R, et al. Attributable Costs of Ventilator-Associated Lower Respiratory Tract Infection (LRTI) Acquired on Intensive Care Units: a Retrospectively Matched Cohort Study. Antimicrobial Resistance and Infection Control, vol. 2, no. 1, 4 Apr. 2013, p. 13., doi:10.1186/2047-2994-2-13 19.Zhu Q, et al. A highly potent extended half-life antibody as a potential RSV vaccine surrogate for all infants. Sci Transl Med. 2017;9:pii: eaaj1928 20.Centers for Disease Control and Prevention. Vaccines & Immunizations. August 18, 2017. https://www.cdc.gov/vaccines/vac-gen/immunity-types.htm. Accessed March 2022. Attachment Source: West Corporation Feb 26, 2022: Banco Santander Late-breaking data at 2022 AAAAI Annual Meeting show Dupixent (dupilumab) significantly improved signs and symptoms of eosinophilic esophagitis Late-breaking data at 2022 AAAAI Annual Meeting show Dupixent (dupilumab) significantly improved signs and symptoms of eosinophilic esophagitis Dupixent 300 mg weekly is the only biologic medicine to show positive, clinically meaningful Phase 3 results in adults and adolescents with eosinophilic esophagitisData continue to support well-established safety profile of DupixentU.S. and global regulatory filings are planned in 2022 Paris and Tarrytown, N.Y., February 26, 2022. Positive detailed results from a second Phase 3 trial showed that Dupixent (dupilumab) 300 mg weekly significantly improved the signs and symptoms of eosinophilic esophagitis (EoE) at 24 weeks compared to placebo in patients 12 years and older. Eosinophilic esophagitis is a chronic, progressive type 2 inflammatory disease that damages the esophagus and prevents it from working properly. These pivotal data will be presented today at the 2022 American Academy of Allergy, Asthma and Immunology (AAAAI) Annual Meeting during a late-breaking oral abstract session. Evan S. Dellon M.D., M.P.H., Professor of Gastroenterology and Hepatology at the University of North Carolina School of Medicine and co-principal investigator of the trial Eosinophilic esophagitis can greatly impact a persons ability to eat normally, and physicians have to rely on invasive medical procedures to monitor and, in more serious cases, stretch the esophagus. Currently, there are no FDA-approved treatment options that address the underlying drivers of this disease. The data from this trial showed dupilumab taken weekly not only improved patients ability to swallow, but also reduced markers of type 2 inflammation in the esophagus, indicating its potential to address a major underlying cause of eosinophilic esophagitis. Topline results from the Dupixent 300 mg weekly arm of the trial, which enrolled 80 patients in the Dupixent group and 79 patients in the placebo group, were announced in October 2021 and confirm results from the first Phase 3 trial. The co-primary endpoints at 24 weeks assessed patient-reported measures of difficulty swallowing (change from baseline in the 0-84 Dysphagia Symptom Questionnaire, or DSQ), and esophageal inflammation (proportion of patients achieving histological disease remission, defined as peak esophageal intraepithelial eosinophil count of 6 eos/high power field [hpf]). Data presented at the 2022 AAAAI Annual Meeting showed that patients treated with Dupixent 300 mg weekly experienced the following changes by week 24 compared to placebo: 64% reduction in disease symptoms from baseline compared to 41% for placebo (p=0.0008). Patients receiving Dupixent experienced a 23.78 point improvement on the DSQ, compared to a 13.86 point improvement for placebo (p<0.0001); baseline DSQ scores were approximately 38 and 36 points, respectively.Nearly 10 times as many patients receiving Dupixent achieved histological disease remission: 59% of patients achieved histological disease remission compared to 6% of patients receiving placebo (p<0.0001); mean baseline peak levels were 89 and 84 eos/hpf, respectively. The safety results of the trial were generally consistent with the known safety profile of Dupixent in its approved indications. For the 24-week treatment period (Dupixent n=80, placebo n=78), overall rates of adverse events were 84% for Dupixent 300 mg weekly and 71% for placebo. Adverse events that were more commonly (5%) observed with Dupixent every week included injection site reactions (38% Dupixent, 33% placebo), fever (6% Dupixent, 1% placebo), sinusitis (5% Dupixent, 0% placebo), COVID-19 (5% Dupixent, 0% placebo) and hypertension (5% Dupixent, 1% placebo). No imbalance was observed in rates of treatment discontinuation due to adverse events between Dupixent (3%) and placebo (3%) groups prior to week 24. The trial also found that significantly more patients treated with Dupixent 300 mg every two weeks reduced their esophageal eosinophilic count to the normal range compared to placebo; however there was not a significant improvement in dysphagia symptoms. Detailed results on the every two week dosing will be presented at an upcoming congress. Data from the clinical trial program have been submitted to the U.S. Food and Drug Administration (FDA). Global regulatory filings in other countries are also planned in 2022. In September 2020, the U.S. FDA granted Breakthrough Therapy designation to Dupixent for the treatment of patients 12 years and older with EoE. Dupixent was also granted Orphan Drug designation for the potential treatment of EoE in 2017. The potential use of Dupixent in EoE is currently under clinical development, and the safety and efficacy have not been fully evaluated by any regulatory authority. About Eosinophilic Esophagitis (EoE) EoE is a chronic, progressive type 2 inflammatory disease that damages the esophagus and prevents it from working properly. For patients with EoE, swallowing the smallest amount of food or taking a sip of water can be a painful and worrisome choking experience. This disease can also cause narrowing of the esophagus and dilation (physical expansion) of the esophagus may be needed, which is often painful. In severe cases, a feeding tube is the only option to ensure proper caloric intake and weight gain. There are approximately 160,000 patients in the U.S. living with EoE who are currently treated, of whom approximately 48,000 have failed multiple treatments. About the Dupixent Eosinophilic Esophagitis Trial The Phase 3 randomized, double-blind, placebo-controlled trial evaluated the efficacy and safety of Dupixent in adolescents and adults with EoE. This second trial (Part B) enrolled 240 patients aged 12 years and older with EoE, as determined by histological and patient-reported measures. Following the first Phase 3 trial (Part A), in which Dupixent 300 mg weekly was evaluated compared to placebo, the second confirmatory trial evaluated Dupixent 300 mg weekly or every two weeks compared to placebo for a 24-week treatment period. The clinical trial program is ongoing, with patients from the first and second trials continuing into a 28-week long-term extension trial (Part C). Full results from this trial will be available later this year. About Dupixent Dupixent is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not an immunosuppressant. IL-4 and IL-13 are key and central drivers of the type 2 inflammation that plays a major role in atopic dermatitis, asthma and chronic rhinosinusitis with nasal polyposis (CRSwNP). Dupixent is currently approved in the U.S., Europe, Japan and other countries around the world for use in specific patients with moderate-to-severe atopic dermatitis, as well as certain patients with asthma or CRSwNP in different age populations. Dupixent is also approved in one or more of these indications in more than 60 countries around the world and more than 350,000 patients have been treated globally. Dupilumab Development Program Dupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement. To date, dupilumab has been studied across 60 clinical trials involving more than 10,000 patients with various chronic diseases driven in part by type 2 inflammation. In addition to the currently approved indications, Sanofi and Regeneron are studying dupilumab in a broad range of diseases driven by type 2 inflammation or other allergic processes, including eosinophilic esophagitis (Phase 3), pediatric atopic dermatitis (6 months to 5 years of age, Phase 3), chronic rhinosinusitis without nasal polyposis (Phase 3), chronic obstructive pulmonary disease with evidence of type 2 inflammation (Phase 3), prurigo nodularis (Phase 3), chronic spontaneous urticaria (Phase 3), bullous pemphigoid (Phase 3), chronic inducible urticaria-cold (Phase 3), allergic fungal rhinosinusitis (Phase 3), allergic bronchopulmonary aspergillosis (Phase 3) and peanut allergy (Phase 2). These potential uses of dupilumab are currently under clinical investigation, and the safety and efficacy in these conditions have not been fully evaluated by any regulatory authority. About Regeneron Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, hematologic conditions, infectious diseases and rare diseases. Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite technologies, such as VelocImmune, which uses unique genetically humanized mice to produce optimized fully human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world. For additional information about the company, please visit www.regeneron.com or follow @Regeneron on Twitter. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Sanofi Media RelationsSally Bain | + 1 617 834 6026 | sally.bain@sanofi.com Sanofi Investor RelationsEva Schaefer-Jansen | + 33 7 86 80 56 39 | eva.schaefer-jansen@sanofi.com Arnaud Delepine | + 33 06 73 69 36 93 | arnaud.delepine@sanofi.com Corentine Driancourt | + 33 06 40 56 92 | corentine.driancourt@sanofi.com Felix Lauscher | + 1 908 612 7239 | felix.lauscher@sanofi.com Priya Nanduri | priya.nanduri@sanofi.com Nathalie Pham | + 33 07 85 93 30 17 | nathalie.pham@sanofi.com Regeneron Media RelationsAshleigh Dixon | + 1 914 374 2422 | ashleigh.dixon@regeneron.com Regeneron Investor RelationsVesna Tosic | + 914 847 5443 | vesna.tosic@regeneron.com Sanofi Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements are generally identified by the words expects, anticipates, believes, intends, estimates, plans and similar expressions. Although Sanofis management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. Any material effect of COVID-19 on any of the foregoing could also adversely impact us. This situation is changing rapidly and additional impacts may arise of which we are not currently aware and may exacerbate other previously identified risks. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under Risk Factors and Cautionary Statement Regarding Forward-Looking Statements in Sanofis annual report on Form 20-F for the year ended December 31, 2021. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. Regeneron Forward-Looking Statements and Use of Digital Media This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. (Regeneron or the Company), and actual events or results may differ materially from these forward-looking statements. Words such as anticipate, expect, intend, plan, believe, seek, estimate, variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the impact of SARS-CoV-2 (the virus that has caused the COVID-19 pandemic) on Regenerons business and its employees, collaborators, and suppliers and other third parties on which Regeneron relies, Regenerons and its collaborators ability to continue to conduct research and clinical programs, Regenerons ability to manage its supply chain, net product sales of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, Regenerons Products), and the global economy; the nature, timing, and possible success and therapeutic applications of Regenerons Products and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, Regenerons Product Candidates) and research and clinical programs now underway or planned, including without limitation Dupixent (dupilumab) for the treatment of eosinophilic esophagitis; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regenerons Product Candidates and new indications for Regenerons Products, such as Dupixent for the treatment of eosinophilic esophagitis, chronic obstructive pulmonary disease with evidence of type 2 inflammation, pediatric atopic dermatitis, bullous pemphigoid, prurigo nodularis, chronic spontaneous urticaria, chronic inducible urticaria-cold, chronic rhinosinusitis without nasal polyposis, allergic fungal rhinosinusitis, allergic bronchopulmonary aspergillosis, peanut allergy, and other potential indications; uncertainty of the utilization, market acceptance, and commercial success of Regenerons Products (such as Dupixent) and Regenerons Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary), including the study discussed in this press release, on any of the foregoing or any potential regulatory approval of Regenerons Products (such as Dupixent) and Regenerons Product Candidates; the ability of Regenerons collaborators, licensees, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regenerons Products and Regenerons Product Candidates; the ability of Regeneron to manage supply chains for multiple products and product candidates; safety issues resulting from the administration of Regenerons Products (such as Dupixent) and Regenerons Product Candidates in patients, including serious complications or side effects in connection with the use of Regenerons Products and Regenerons Product Candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict Regenerons ability to continue to develop or commercialize Regenerons Products and Regenerons Product Candidates, including without limitation Dupixent; ongoing regulatory obligations and oversight impacting Regenerons Products, research and clinical programs, and business, including those relating to patient privacy; the availability and extent of reimbursement of Regenerons Products from third-party payers, including private payer healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payers and new policies and procedures adopted by such payers; competing drugs and product candidates that may be superior to, or more cost effective than, Regenerons Products and Regenerons Product Candidates; the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators or licensees may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license, collaboration, or supply agreement, including Regenerons agreements with Sanofi, Bayer, and Teva Pharmaceutical Industries Ltd. (or their respective affiliated companies, as applicable) to be cancelled or terminated; and risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA (aflibercept) Injection, Dupixent, Praluent (alirocumab), and REGEN-COV (casirivimab and imdevimab), other litigation and other proceedings and government investigations relating to the Company and/or its operations, the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regenerons business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regenerons filings with the U.S. Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2021. Any forward-looking statements are made based on managements current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise. Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regenerons media and investor relations website (http://newsroom.regeneron.com) and its Twitter feed (http://twitter.com/regeneron). Attachment Source: West Corporation Feb 25, 2022: Banco Santander Sanofi and GSK to seek regulatory authorization for COVID-19 vaccine Sanofi and GSK to seek regulatory authorization for COVID-19 vaccine * Final analysis of the global VAT02 booster trial confirms universal ability to boost neutralizing antibodies 18- to 30-fold across vaccine platforms (mRNA, adenovirus) * In the VAT08 Phase 3 primary series trial, two doses of the Sanofi-GSK vaccine in seronegative populations demonstrated:* 100% efficacy against severe COVID-19 disease and hospitalizations * 75% efficacy against moderate or severe COVID-19 disease* 57.9% efficacy against any symptomatic COVID-19 disease, in line with expected vaccine effectiveness in todays environment dominated by variants of concern * Favorable safety profile following both primary series and booster vaccinations Paris, February 23, 2022. Sanofi and GSK today announce that they intend to submit data from both their booster and Phase 3 efficacy trials as the basis for regulatory applications for a COVID-19 vaccine. The public health relevance of the refrigerator temperature-stable adjuvanted protein-based Sanofi-GSK vaccine is strongly supported by the induction of robust immune responses and a favorable safety profile in multiple settings. In participants who had received a primary series of an already authorized mRNA or adenovirus vaccine, the Sanofi-GSK booster vaccine induced a significant increase in neutralizing antibodies of 18- to 30-fold across vaccine platforms and age groups. When the Sanofi-GSK vaccine was used as a two-dose primary series followed by a booster dose, neutralizing antibodies increased 84- to 153-fold compared to pre-boost levels. Thomas TriompheExecutive Vice President, Sanofi VaccinesWere very pleased with these data, which confirm our strong science and the benefits of our COVID-19 vaccine. The Sanofi-GSK vaccine demonstrates a universal ability to boost all platforms and across all ages. We also observed robust efficacy of the vaccine as a primary series in todays challenging epidemiological environment. No other global Phase 3 efficacy study has been undertaken during this period with so many variants of concern, including Omicron, and these efficacy data are similar to the recent clinical data from authorized vaccines. Roger ConnorPresident of GSK VaccinesThe evolving epidemiology of COVID-19 demonstrates the need for a variety of vaccines. Our adjuvanted protein-based vaccine candidate uses a well-established approach that has been applied widely to prevent infection with other viruses including pandemic flu. We are confident that this vaccine can play an important role as we continue to address this pandemic and prepare for the post-pandemic period. When used as a two-dose primary series, the Sanofi-GSK vaccine delivered robust levels of neutralizing antibodies, with GMTs reaching 3711 units. For comparison, a panel of sera from volunteers in the same age range who received two doses of an already approved and highly effective mRNA vaccine displayed a GMT of 1653 units, measured simultaneously in the same laboratory. Data from the VAT08 efficacy study showed that two doses of Sanofi-GSK vaccine generated an efficacy of 57.9% (95% confidence interval [CI, 26.5, 76.7]) against any symptomatic COVID-19 disease in the seronegative population. The Sanofi-GSK vaccine provided 100% protection (0 vs 10 cases post-dose 1, 0 vs 4 cases post-dose 2) against severe disease and hospitalizations and 75% (3 vs 11 cases) efficacy against moderate-to-severe disease in seronegative populations. While sequencing is still in progress, early data indicate 77% efficacy against any Delta variant-associated symptomatic COVID-19 disease, in line with expected vaccine effectiveness. Across both studies, the Sanofi-GSK vaccine was well-tolerated in younger and older adults with no safety concerns. The companies are in discussions with regulatory authorities, including the US FDA and European Medicines Agency (EMA), and plan to submit the totality of the data generated with this vaccine candidate to support regulatory authorizations. About VAT08 and VAT02The Phase 3 trial, VAT08 is evaluating a 10g antigen formulation of the SARS-CoV-2 adjuvanted recombinant protein-based vaccinefor efficacy, immunogenicity and safety compared to a placebo. Stage one of the trial is assessing the efficacy of a vaccine formulation containing the spike protein against the original D614 (parent) virus in more than 10,000 participants >18 years of age, randomized to receive two doses of 10g vaccine or placebo at day 1 and day 22 across sites in the US, Asia, Africa and Latin America. Enrolment recently completed for a second stage in the trial, evaluating a second bivalent formulation, including the spike protein of the B.1.351 (Beta) variant. The Phase 3 trial follows positive initial results from a Phase 2 clinical trial (VAT00002). In that trial, the COVID-19 vaccine candidate was administered to 722 adults to assess the safety, reactogenicity and immunogenicity of 2 doses and to identify an optimal dosing for use as a booster. Results showed strong rates of neutralizing antibody response with 95% to 100% seroconversion following a second injection in all age groups (18 to 95 years old), across all doses. Full study results for both VAT08 and VAT02 will be published later this year. These efforts are supported by federal funds from the Biomedical Advanced Research and Development Authority, part of the office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services in collaboration with the U.S. Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense under Contract # W15QKN-16-9-1002 and by the National Institute of Allergy and Infectious Diseases (NIAID). The NIAID provides grant funding to the HIV Vaccine Trials Network (HVTN) Leadership and Operations Center (UM1 AI 68614HVTN), the Statistics and Data Management Center (UM1 AI 68635), the HVTN Laboratory Center (UM1 AI 68618), the HIV Prevention Trials Network Leadership and Operations Center (UM1 AI 68619), the AIDS Clinical Trials Group Leadership and Operations Center (UM1 AI 68636), and the Infectious Diseases Clinical Research Consortium (UM1 AI 148684, UM1 AI 148450, UM1 AI 148372 , UM1 AI 148574). About the Sanofi and GSK partnership In the collaboration between the two companies, Sanofi provides its recombinant antigen and GSK contributes its pandemic adjuvant, both established vaccine platforms that have proven successful against influenza. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Media RelationsNicolas Obrist|+ 33 6 77 21 27 55 |nicolas.obrist@sanofi.comVictor Rouault|+ 33 6 70 93 71 40 |victor.rouault@sanofi.comKate Conway|+ 1508 364 4931 |kate.conway@sanofi.com Investor RelationsEva Schaefer-Jansen|+ 33 7 86 80 56 39 |eva.schaefer-jansen@sanofi.comArnaud Delepine|+ 33 6 73 69 36 93 | arnaud.delepine@sanofi.comCorentine Driancourt|+ 33 6 40 56 92 21 | corentine.driancourt@sanofi.comFelix Lauscher|+ 1908612 7239 | felix.lauscher@sanofi.comPriya Nanduri| +1 908 981 5560 |priya.nanduri@sanofi.com Nathalie Pham|+ 33 7 85 93 30 17 | nathalie.pham@sanofi.com Sanofi Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words expects, anticipates, believes, intends, estimates, plans and similar expressions. Although Sanofis management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofis ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. Any material effect of COVID-19 on any of the foregoing could also adversely impact us. This situation is changing rapidly and additional impacts may arise of which we are not currently aware and may exacerbate other previously identified risks. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under Risk Factors and Cautionary Statement Regarding Forward-Looking Statements in Sanofis annual report on Form 20-F for the year ended December 31, 2020. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements Attachment Press_Release_Sanofi Source: West Corporation Feb 23, 2022: Banco Santander Filing of the 2021 U.S. Form 20-F and French Document dEnregistrement Universel containing the Annual Financial Report Filing of the 2021 U.S. Form 20-F and French Document dEnregistrement Universel containing the Annual Financial Report Paris, February 23, 2022. Sanofi announces today the filing of its Form 20-F with the U.S. Securities and Exchange Commission (SEC) and its Document dEnregistrement Universel containing its Annual Financial Report with the French market regulator Autorite des marches financiers (AMF). These documents are available on the companys website: https://www.sanofi.com/en/investors/reports-and-publications/financial-and-csr-reports. In addition, the Form 20-F is available on the website of the SEC (www.sec.gov) and the Document dEnregistrement Universel is available on the website of the AMF (www.amf-france.org). A hard copy of these documents, each of which contains our complete audited financial statements, may be received free of charge, upon request. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Media RelationsNicolas Obrist|+ 33 6 77 21 27 55 |nicolas.obrist@sanofi.comVictor Rouault|+ 33 6 70 93 71 40 |victor.rouault@sanofi.comKate Conway|+ 1508 364 4931 |kate.conway@sanofi.com Investor RelationsEva Schaefer-Jansen|+ 33 7 86 80 56 39 |eva.schaefer-jansen@sanofi.comArnaud Delepine|+ 33 6 73 69 36 93 | arnaud.delepine@sanofi.comCorentine Driancourt|+ 33 6 40 56 92 21 | corentine.driancourt@sanofi.comFelix Lauscher|+ 1908612 7239 | felix.lauscher@sanofi.comPriya Nanduri| +1 908 981 5560 |priya.nanduri@sanofi.com Nathalie Pham|+ 33 7 85 93 30 17 | nathalie.pham@sanofi.com Attachment Press_Release Source: West Corporation Feb 23, 2022: Banco Santander Sanofi and GSK to seek regulatory authorization for COVID-19 vaccine Sanofi and GSK to seek regulatory authorization for COVID-19 vaccine * Final analysis of the global VAT02 booster trial confirms universal ability to boost neutralizing antibodies 18- to 30-fold across vaccine platforms (mRNA, adenovirus) * In the VAT08 Phase 3 primary series trial, two doses of the Sanofi-GSK vaccine in seronegative populations demonstrated:* 100% efficacy against severe COVID-19 disease and hospitalizations * 75% efficacy against moderate or severe COVID-19 disease* 57.9% efficacy against any symptomatic COVID-19 disease, in line with expected vaccine effectiveness in todays environment dominated by variants of concern * Favorable safety profile following both primary series and booster vaccinations Paris, February 23, 2022. Sanofi and GSK today announce that they intend to submit data from both their booster and Phase 3 efficacy trials as the basis for regulatory applications for a COVID-19 vaccine. The public health relevance of the refrigerator temperature-stable adjuvanted protein-based Sanofi-GSK vaccine is strongly supported by the induction of robust immune responses and a favorable safety profile in multiple settings. In participants who had received a primary series of an already authorized mRNA or adenovirus vaccine, the Sanofi-GSK booster vaccine induced a significant increase in neutralizing antibodies of 18- to 30-fold across vaccine platforms and age groups. When the Sanofi-GSK vaccine was used as a two-dose primary series followed by a booster dose, neutralizing antibodies increased 84- to 153-fold compared to pre-boost levels (see Figures 1a and 1b for details). Thomas TriompheExecutive Vice President, Sanofi VaccinesWere very pleased with these data, which confirm our strong science and the benefits of our COVID-19 vaccine. The Sanofi-GSK vaccine demonstrates a universal ability to boost all platforms and across all ages. We also observed robust efficacy of the vaccine as a primary series in todays challenging epidemiological environment. No other global Phase 3 efficacy study has been undertaken during this period with so many variants of concern, including Omicron, and these efficacy data are similar to the recent clinical data from authorized vaccines. Roger ConnorPresident of GSK VaccinesThe evolving epidemiology of COVID-19 demonstrates the need for a variety of vaccines. Our adjuvanted protein-based vaccine candidate uses a well-established approach that has been applied widely to prevent infection with other viruses including pandemic flu. We are confident that this vaccine can play an important role as we continue to address this pandemic and prepare for the post-pandemic period. When used as a two-dose primary series, the Sanofi-GSK vaccine delivered robust levels of neutralizing antibodies, with GMTs reaching 3711 units. For comparison, a panel of sera from volunteers in the same age range who received two doses of an already approved and highly effective mRNA vaccine displayed a GMT of 1653 units, measured simultaneously in the same laboratory. Data from the VAT08 efficacy study showed that two doses of Sanofi-GSK vaccine generated an efficacy of 57.9% (95% confidence interval [CI, 26.5, 76.7]) against any symptomatic COVID-19 disease in the seronegative population. The Sanofi-GSK vaccine provided 100% protection (0 vs 10 cases post-dose 1, 0 vs 4 cases post-dose 2) against severe disease and hospitalizations and 75% (3 vs 11 cases) efficacy against moderate-to-severe disease in seronegative populations. While sequencing is still in progress, early data indicate 77% efficacy against any Delta variant-associated symptomatic COVID-19 disease, in line with expected vaccine effectiveness. Across both studies, the Sanofi-GSK vaccine was well-tolerated in younger and older adults with no safety concerns. The companies are in discussions with regulatory authorities, including the US FDA and European Medicines Agency (EMA), and plan to submit the totality of the data generated with this vaccine candidate to support regulatory authorizations. Figure 1a - Pre- vs post-booster neutralizing antibody titers in 18-55-yr old participants. Geometric Mean Titers (GMT) (95% CI). Figure 1b - Pre- vs post-booster neutralizing antibody in 56-yr old participants. Geometric Mean Titers (GMT) (95% CI). To evaluate the immunogenicity of the Sanofi-GSK vaccine as a booster, human immune sera samples were tested by Monogram Biosciences [San Francisco, CA] using an FDA-approved standardized pseudovirus neutralization test (pVNT) against the D614G prototype virus. About VAT08 and VAT02The Phase 3 trial, VAT08 is evaluating a 10g antigen formulation of the SARS-CoV-2 adjuvanted recombinant protein-based vaccinefor efficacy, immunogenicity and safety compared to a placebo. Stage one of the trial is assessing the efficacy of a vaccine formulation containing the spike protein against the original D614 (parent) virus in more than 10,000 participants >18 years of age, randomized to receive two doses of 10g vaccine or placebo at day 1 and day 22 across sites in the US, Asia, Africa and Latin America. Enrolment recently completed for a second stage in the trial, evaluating a second bivalent formulation, including the spike protein of the B.1.351 (Beta) variant. The Phase 3 trial follows positive initial results from a Phase 2 clinical trial (VAT00002). In that trial, the COVID-19 vaccine candidate was administered to 722 adults to assess the safety, reactogenicity and immunogenicity of 2 doses and to identify an optimal dosing for use as a booster. Results showed strong rates of neutralizing antibody response with 95% to 100% seroconversion following a second injection in all age groups (18 to 95 years old), across all doses. Full study results for both VAT08 and VAT02 will be published later this year. These efforts are supported by federal funds from the Biomedical Advanced Research and Development Authority, part of the office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services in collaboration with the U.S. Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense under Contract # W15QKN-16-9-1002 and by the National Institute of Allergy and Infectious Diseases (NIAID). The NIAID provides grant funding to the HIV Vaccine Trials Network (HVTN) Leadership and Operations Center (UM1 AI 68614HVTN), the Statistics and Data Management Center (UM1 AI 68635), the HVTN Laboratory Center (UM1 AI 68618), the HIV Prevention Trials Network Leadership and Operations Center (UM1 AI 68619), the AIDS Clinical Trials Group Leadership and Operations Center (UM1 AI 68636), and the Infectious Diseases Clinical Research Consortium (UM1 AI 148684, UM1 AI 148450, UM1 AI 148372 , UM1 AI 148574). About the Sanofi and GSK partnership In the collaboration between the two companies, Sanofi provides its recombinant antigen and GSK contributes its pandemic adjuvant, both established vaccine platforms that have proven successful against influenza. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Media RelationsNicolas Obrist|+ 33 6 77 21 27 55 |nicolas.obrist@sanofi.comVictor Rouault|+ 33 6 70 93 71 40 |victor.rouault@sanofi.comKate Conway|+ 1508 364 4931 |kate.conway@sanofi.com Investor RelationsEva Schaefer-Jansen|+ 33 7 86 80 56 39 |eva.schaefer-jansen@sanofi.comArnaud Delepine|+ 33 6 73 69 36 93 | arnaud.delepine@sanofi.comCorentine Driancourt|+ 33 6 40 56 92 21 | corentine.driancourt@sanofi.comFelix Lauscher|+ 1908612 7239 | felix.lauscher@sanofi.comPriya Nanduri| +1 908 981 5560 |priya.nanduri@sanofi.com Nathalie Pham|+ 33 7 85 93 30 17 | nathalie.pham@sanofi.com Sanofi Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words expects, anticipates, believes, intends, estimates, plans and similar expressions. Although Sanofis management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofis ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. Any material effect of COVID-19 on any of the foregoing could also adversely impact us. This situation is changing rapidly and additional impacts may arise of which we are not currently aware and may exacerbate other previously identified risks. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under Risk Factors and Cautionary Statement Regarding Forward-Looking Statements in Sanofis annual report on Form 20-F for the year ended December 31, 2020. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements Attachment Press_Release Source: West Corporation Feb 18, 2022: Banco Santander Update on ongoing Dupixent (dupilumab) chronic spontaneous urticaria Phase 3 program Update on ongoing Dupixent (dupilumab) chronic spontaneous urticaria Phase 3 program In a Phase 3 trial in patients refractory to omalizumab, Dupixent did not reach statistical significance in an interim analysis despite numeric improvements observed across key endpoints; trial will be stopped due to futilityPositive results from a previous Phase 3 trial in biologic-naive patients showed Dupixent significantly reduced itch and hives compared to standard of care Companies remain committed to advancing Dupixent for patients with chronic spontaneous urticaria uncontrolled on antihistamines and are evaluating next steps PARIS and TARRYTOWN, N.Y., February 18, 2022. A Phase 3 trial (CUPID STUDY B) evaluating Dupixent (dupilumab) in patients with chronic spontaneous urticaria (CSU), who were refractory to omalizumab, will stop due to futility based on a pre-specified interim analysis. Although positive numerical trends in reducing itch and hives were observed, the results from the interim analysis did not demonstrate statistical significance for the primary endpoints. The analysis was conducted by an independent interim analysis review committee. In the trial, patients who were refractory to omalizumab treatment and uncontrolled on antihistamines received Dupixent plus standard of care compared to standard of care alone for 24 weeks. The safety data were generally consistent with the known safety profile of Dupixent in its approved indications. The LIBERTY-CUPID pivotal program was initiated in 2020 with an accelerated direct-to-Phase 3 strategy. The previously reported Phase 3 trial, which evaluated a different group of patients who were biologic-naive, met its primary and all key secondary endpoints at 24 weeks showing that adding Dupixent to standard-of-care antihistamines significantly reduced itch and hives compared to antihistamines alone. The companies remain committed to advancing Dupixent for patients with CSU uncontrolled on antihistamines and are evaluating next steps. John Reed, M.D., Ph.D. Executive Vice President, Global Head of Research and Development at Sanofi Although we are disappointed in these latest results, this interim analysis contributes to furthering our understanding of the role of type 2 inflammation in this subset of CSU patients who are refractory to all other approved therapies. Based on the results seen in our first Phase 3 trial, and the numerical trends observed in this interim analysis, we remain committed to advancing Dupixent as an option for patients suffering from CSU who are uncontrolled on anti-histamines. We look forward to discussing next steps with regulators. Detailed results from the first trial will be presented at the AAAAI Annual Meeting later this month and the companies expect to share results from the second trial in a scientific forum. Sanofi and Regeneron are rapidly advancing a broad clinical development program to evaluate Dupixent in diseases with significant unmet need and where type 2 inflammation may play a role. The companies also recently announced positive Phase 3 results in eosinophilic esophagitis (EoE) and prurigo nodularis (PN), and additional results are also expected later this year in pediatric EoE, chronic inducible urticaria-cold (CindU), and hand and foot atopic dermatitis. The potential use of Dupixent in CSU, EoE, PN, CindU and hand and foot atopic dermatitis are currently under clinical development and the safety and efficacy have not been fully evaluated by any regulatory authority. About Chronic Spontaneous Urticaria CSU is a chronic inflammatory skin disease characterized by the sudden onset of hives on the skin and/or swelling deep under the skin. Despite standard-of-care treatment, people with CSU often experience symptoms including a persistent itch or burning sensation, which can be debilitating and significantly impact quality of life. Swelling often occurs on the face, hands and feet, but can also affect the throat and upper airways. About the Dupixent Phase 3 Program in CSU (LIBERTY-CUPID) Study B of the Phase 3 randomized, double-blind, placebo-controlled LIBERTY-CUPID clinical program evaluated the efficacy and safety of Dupixent in 83 patients with CSU aged 12 to 80 years who remained symptomatic despite standard-of-care treatment and were intolerant or incomplete responders to omalizumab. During the 24-week treatment period, patients received Dupixent, or placebo every two weeks added to standard-of-care antihistamines. The primary endpoints assessed the change from baseline in itch (measured by the weekly itch severity score) and the change from baseline in itch and hives (measured by the weekly urticaria activity score) at 24 weeks. Study A of clinical program evaluated the efficacy and safety of Dupixent as an add-on therapy to standard-of-care antihistamines compared to antihistamines alone in 138 patients aged 6 years and older with CSU who remained symptomatic despite antihistamine use and were not previously treated with omalizumab. About Dupixent Dupixent is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not an immunosuppressant. IL-4 and IL-13 are key and central drivers of the type 2 inflammation that plays a major role in atopic dermatitis, asthma and chronic rinusinusitis with nasal polyps (CRSwNP). Dupixent is currently approved in the U.S., Europe, Japan and other countries around the world for use in specific patients with moderate-to-severe atopic dermatitis, as well as certain patients with asthma or CRSwNP in different age populations. Dupixent is also approved in one or more of these indications in more than 60 countries around the world and more than 350,000 patients have been treated globally. Dupilumab Development Program Dupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement. To date, dupilumab has been studied across 60 clinical trials involving more than 10,000 patients with various chronic diseases driven in part by type 2 inflammation. In addition to the currently approved indications, Sanofi and Regeneron are studying dupilumab in a broad range of diseases driven by type 2 inflammation or other allergic processes including chronic spontaneous urticaria (Phase 3), chronic inducible urticaria-cold (Phase 3), pediatric atopic dermatitis (6 months to 5 years of age, Phase 3), prurigo nodularis (Phase 3), eosinophilic esophagitis (Phase 3), chronic obstructive pulmonary disease with evidence of type 2 inflammation (Phase 3), bullous pemphigoid (Phase 3), chronic rhinosinusitis without nasal polyposis (Phase 3), allergic fungal rhinosinusitis (Phase 3), allergic bronchopulmonary aspergillosis (Phase 3) and peanut allergy (Phase 2). These potential uses of dupilumab are currently under clinical investigation, and the safety and efficacy in these conditions have not been fully evaluated by any regulatory authority. About Regeneron Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, hematologic conditions, infectious diseases and rare diseases. Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite technologies, such as VelocImmune, which uses unique genetically humanized mice to produce optimized fully human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world. For additional information about the company, please visit www.regeneron.com or follow @Regeneron on Twitter. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Sanofi Media RelationsSally Bain | + 1 617 834 6026 | sally.bain@sanofi.com Sanofi Investor RelationsEva Schaefer-Jansen | + 33 7 86 80 56 39 | eva.schaefer-jansen@sanofi.com Arnaud Delepine | + 33 06 73 69 36 93 | arnaud.delepine@sanofi.com Corentine Driancourt | + 33 06 40 56 92 | corentine.driancourt@sanofi.com Felix Lauscher | + 1 908 612 7239 | felix.lauscher@sanofi.com Priya Nanduri | priya.nanduri@sanofi.com Nathalie Pham | + 33 07 85 93 30 17 | nathalie.pham@sanofi.com Regeneron Media RelationsHannah Kwagh | + 1 914 847 6314 | hannah.kwagh@regeneron.com Regeneron Investor RelationsVesna Tosic | + 914 847 5443 | vesna.tosic@regeneron.com Sanofi Disclaimers or Forward-Looking Statements This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements are generally identified by the words expects, anticipates, believes, intends, estimates, plans and similar expressions. Although Sanofis management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. Any material effect of COVID-19 on any of the foregoing could also adversely impact us. This situation is changing rapidly and additional impacts may arise of which we are not currently aware and may exacerbate other previously identified risks. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under Risk Factors and Cautionary Statement Regarding Forward-Looking Statements in Sanofis annual report on Form 20-F for the year ended December 31, 2020. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. Regeneron Forward-Looking Statements and Use of Digital Media This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance ofRegeneron Pharmaceuticals, Inc. (Regeneron or the Company), and actual events or results may differ materially from these forward-looking statements. Words such as anticipate, expect, intend, plan, believe, seek, estimate, variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the impact of SARS-CoV-2 (the virus that has caused the COVID-19 pandemic) on Regenerons business and its employees, collaborators, and suppliers and other third parties on which Regeneron relies, Regenerons and its collaborators ability to continue to conduct research and clinical programs, Regenerons ability to manage its supply chain, net product sales of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, Regenerons Products), and the global economy; the nature, timing, and possible success and therapeutic applications of Regenerons Products and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, Regenerons Product Candidates) and research and clinical programs now underway or planned, including without limitation Dupixent (dupilumab) for the treatment of chronic spontaneous urticaria (CSU); the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators or licensees, such as the LIBERTY-CUPID clinical program (including Study A of the program, results of which were previously reported), may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; uncertainty of the utilization, market acceptance, and commercial success of Regenerons Products (such as Dupixent) and Regenerons Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary), including the studies discussed or referenced in this press release, on any of the foregoing or any potential regulatory approval of Regenerons Products (such as Dupixent for the treatment of CSU) and Regenerons Product Candidates; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regenerons Product Candidates and new indications for Regenerons Products, such asDupixent for the treatment ofCSU, pediatric atopic dermatitis, chronic obstructive pulmonary disease with evidence of type 2 inflammation, eosinophilic esophagitis, bullous pemphigoid, prurigo nodularis, chronic inducible urticaria-cold, chronic rhinosinusitis without nasal polyposis, allergic fungal rhinosinusitis, allergic bronchopulmonary aspergillosis, peanut allergy, and other potential indications;the ability of Regenerons collaborators, licensees, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regenerons Products and Regenerons Product Candidates; the ability of Regeneron to manage supply chains for multiple products and product candidates; safety issues resulting from the administration of Regenerons Products (such as Dupixent) and Regenerons Product Candidates in patients, including serious complications or side effects in connection with the use of Regenerons Products and Regenerons Product Candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict Regenerons ability to continue to develop or commercialize Regenerons Products and Regenerons Product Candidates, including without limitation Dupixent; ongoing regulatory obligations and oversight impacting Regenerons Products, research and clinical programs, and business, including those relating to patient privacy; the availability and extent of reimbursement of Regenerons Products from third-party payers, including private payer healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payers and new policies and procedures adopted by such payers; competing drugs and product candidates that may be superior to, or more cost effective than, Regenerons Products and Regenerons Product Candidates; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license, collaboration, or supply agreement, including Regenerons agreements with Sanofi, Bayer, and Teva Pharmaceutical Industries Ltd. (or their respective affiliated companies, as applicable) to be cancelled or terminated; and risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA(aflibercept) Injection, Dupixent, Praluent(alirocumab), and REGEN-COV (casirivimab and imdevimab)), other litigation and other proceedings and government investigations relating to the Company and/or its operations, the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regenerons business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regenerons filings with theU.S. Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2021. Any forward-looking statements are made based on managements current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise. Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regenerons media and investor relations website (http://newsroom.regeneron.com) and its Twitter feed (http://twitter.com/regeneron). Attachment Source: West Corporation Feb 10, 2022: Banco Santander FDA accepts Dupixent (dupilumab) for Priority Review in children aged 6 months to 5 years with moderate-to-severe atopic dermatitis FDA accepts Dupixent (dupilumab) for Priority Review in children aged 6 months to 5 years with moderate-to-severe atopic dermatitis If approved, Dupixent will be the first biologic medicine available in the U.S. to treat uncontrolled moderate-to-severe atopic dermatitis for these young children Paris and Tarrytown, N.Y., February 10, 2022. The U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent (dupilumab) as an add-on maintenance treatment for children aged 6 months to 5 years with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. The target action date for the FDA decision on this investigational use is June 9, 2022. Dupixent remains the only biologic medicine approved for patients 6 years of age and older in this indication. Atopic dermatitis is a chronic type 2 inflammatory skin disease, and 85 to 90% of patients develop symptoms (onset of disease) before 5 years of age, which can often continue through adulthood. Symptoms include intense, persistent itch and skin lesions that cover much of the body, resulting in skin dryness, cracking, pain, redness or darkening, and crusting and oozing, along with increased risk of skin infections. Moderate-to-severe atopic dermatitis may also significantly impact the quality of life of a young child, their parents and caregivers. Current treatment options in this age group are primarily topical steroids, which can be associated with safety risks and may impair growth when used long-term. The sBLA is supported by data from the pivotal Phase 3 trial evaluating the efficacy and safety of Dupixent added to standard-of-care topical corticosteroids (TCS) in children aged 6 months to 5 years with uncontrolled moderate-to-severe atopic dermatitis. The trial met all primary and secondary endpoints, showing that Dupixent and TCS significantly improved skin clearance and reduced overall disease severity and itch at 16 weeks compared to TCS alone. Safety results were generally consistent with the safety profile of Dupixent in atopic dermatitis for patients aged 6 years and older. The most common adverse events that were more commonly observed with Dupixent included conjunctivitis and herpes viral infections. The use of Dupixent in children younger than 6 years of age with moderate-to-severe atopic dermatitis is currently under clinical investigation and its safety and efficacy have not been fully evaluated by any regulatory authority. In 2016, the FDA granted Breakthrough Therapy designation for Dupixent for the treatment of severe atopic dermatitis (in children aged 6 months to 11 years). About DupixentDupixent is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not an immunosuppressant. IL-4 and IL-13 are key and central drivers of the type 2 inflammation that plays a major role in atopic dermatitis, asthma and chronic rhinosinusitis with nasal polyposis (CRSwNP). In the U.S., Dupixent is approved in patients aged 6 years and older with uncontrolled moderate-to-severe atopic dermatitis; as an add-on maintenance treatment of patients aged 6 years and older with moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid-dependent asthma; and for use with other medicines for the maintenance treatment of chronic rhinosinusitis with nasal polyposis (CRSwNP) in adults whose disease is not controlled. Dupixent is also approved in Europe, Japan and other countries around the world for use in specific patients with moderate-to-severe atopic dermatitis and certain patients with asthma or CRSwNP in different age populations. Dupixent is approved in one or more of these indications in more than 60 countries around the world, and more than 350,000 patients have been treated globally. Dupilumab Development ProgramDupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement. To date, dupilumab has been studied across 60 clinical trials involving more than 10,000 patients with various chronic diseases driven in part by type 2 inflammation. In addition to the currently approved indications, Sanofi and Regeneron are studying dupilumab in a broad range of diseases driven by type 2 inflammation or other allergic processes, including pediatric atopic dermatitis (6 months to 5 years of age, Phase 3), chronic obstructive pulmonary disease with evidence of type 2 inflammation (Phase 3), eosinophilic esophagitis (Phase 3), bullous pemphigoid (Phase 3), prurigo nodularis (Phase 3), chronic spontaneous urticaria (Phase 3), chronic inducible urticaria-cold (Phase 3), chronic rhinosinusitis without nasal polyposis (Phase 3), allergic fungal rhinosinusitis (Phase 3), allergic bronchopulmonary aspergillosis (Phase 3) and peanut allergy (Phase 2). These potential uses of dupilumab are currently under clinical investigation, and the safety and efficacy in these conditions have not been fully evaluated by any regulatory authority. About Regeneron Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, hematologic conditions, infectious diseases and rare diseases. Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite technologies, such as VelocImmune, which uses unique genetically humanized mice to produce optimized fully human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world. For additional information about the company, please visit www.regeneron.com or follow @Regeneron on Twitter. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Sanofi Media RelationsSally Bain | + 1 617 834 6026 | sally.bain@sanofi.com Sanofi Investor RelationsEva Schaefer-Jansen | + 33 7 86 80 56 39 | eva.schaefer-jansen@sanofi.com Arnaud Delepine | + 33 06 73 69 36 93 | arnaud.delepine@sanofi.com Corentine Driancourt | + 33 06 40 56 92 | corentine.driancourt@sanofi.com Felix Lauscher | + 1 908 612 7239 | felix.lauscher@sanofi.com Priya Nanduri | +1 908 981 5560 | priya.nanduri@sanofi.com Nathalie Pham | + 33 07 85 93 30 17 | nathalie.pham@sanofi.com Regeneron Media RelationsHannah Kwagh | + 1 914 847 6314 | hannah.kwagh@regeneron.com Regeneron Investor RelationsVesna Tosic | + 914 847 5443 | vesna.tosic@regeneron.com Sanofi Disclaimers or Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements are generally identified by the words expects, anticipates, believes, intends, estimates, plans and similar expressions. Although Sanofis management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. Any material effect of COVID-19 on any of the foregoing could also adversely impact us. This situation is changing rapidly and additional impacts may arise of which we are not currently aware and may exacerbate other previously identified risks. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under Risk Factors and Cautionary Statement Regarding Forward-Looking Statements in Sanofis annual report on Form 20-F for the year ended December 31, 2020. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. Regeneron Forward-Looking Statements and Use of Digital Media This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. (Regeneron or the Company), and actual events or results may differ materially from these forward-looking statements. Words such as anticipate, expect, intend, plan, believe, seek, estimate, variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the impact of SARS-CoV-2 (the virus that has caused the COVID-19 pandemic) on Regenerons business and its employees, collaborators, and suppliers and other third parties on which Regeneron relies, Regenerons and its collaborators ability to continue to conduct research and clinical programs, Regenerons ability to manage its supply chain, net product sales of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, Regenerons Products), and the global economy; the nature, timing, and possible success and therapeutic applications of Regenerons Products and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, Regenerons Product Candidates) and research and clinical programs now underway or planned, including without limitation Dupixent (dupilumab) for the treatment of moderate-to-severe atopic dermatitis in children aged 6 months to 5 years (Infant/Young Children AD); the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regenerons Product Candidates and new indications for Regenerons Products, such as Dupixent for the treatment of Infant/Young Children AD (including potential U.S. Food and Drug Administration approval based on the supplemental Biologics License Application discussed in this press release), chronic obstructive pulmonary disease with evidence of type 2 inflammation, eosinophilic esophagitis, bullous pemphigoid, prurigo nodularis, chronic spontaneous urticaria, chronic inducible urticaria-cold, chronic rhinosinusitis without nasal polyposis, allergic fungal rhinosinusitis, allergic bronchopulmonary aspergillosis, peanut allergy, and other potential indications; uncertainty of the utilization, market acceptance, and commercial success of Regenerons Products (such as Dupixent) and Regenerons Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary), including the study discussed in this press release, on any of the foregoing or any potential regulatory approval of Regenerons Products (such as Dupixent) and Regenerons Product Candidates; the ability of Regenerons collaborators, licensees, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regenerons Products and Regenerons Product Candidates; the ability of Regeneron to manage supply chains for multiple products and product candidates; safety issues resulting from the administration of Regenerons Products (such as Dupixent) and Regenerons Product Candidates in patients, including serious complications or side effects in connection with the use of Regenerons Products and Regenerons Product Candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict Regenerons ability to continue to develop or commercialize Regenerons Products and Regenerons Product Candidates, including without limitation Dupixent; ongoing regulatory obligations and oversight impacting Regenerons Products, research and clinical programs, and business, including those relating to patient privacy; the availability and extent of reimbursement of Regenerons Products from third-party payers, including private payer healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payers and new policies and procedures adopted by such payers; competing drugs and product candidates that may be superior to, or more cost effective than, Regenerons Products and Regenerons Product Candidates; the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators or licensees may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license, collaboration, or supply agreement, including Regenerons agreements with Sanofi, Bayer, and Teva Pharmaceutical Industries Ltd. (or their respective affiliated companies, as applicable) to be cancelled or terminated; and risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA (aflibercept) Injection, Dupixent, Praluent (alirocumab), and REGEN-COV (casirivimab and imdevimab)), other litigation and other proceedings and government investigations relating to the Company and/or its operations, the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regenerons business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regenerons filings with the U.S. Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2021. Any forward-looking statements are made based on managements current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise.Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regenerons media and investor relations website (http://newsroom.regeneron.com) and its Twitter feed (http://twitter.com/regeneron). Attachment Source: West Corporation Feb 09, 2022: Banco Santander Olipudase alfa shown to provide sustained improvement across multiple clinical manifestations of ASMD Olipudase alfa shown to provide sustained improvement across multiple clinical manifestations of ASMD Investigational data from long-term, follow-up studies showed that olipudase alfa provided sustained improvement in lung function (as measured by DLco) and reduction of spleen and liver volumes over time in patients with ASMDIf approved, olipudase alfa will become the first-and-only therapy for the treatment of ASMD Paris, February 9, 2022. Positive results from long-term, open-label extension studies demonstrated that olipudase alfa provided sustained improvement in lung function (as measured by diffusing capacity of the lung for carbon monoxide, or DLco) and reduction of spleen and liver volumes in adult and pediatric patients with non-central nervous system (non-CNS) manifestations of acid sphingomyelinase deficiency (ASMD), a rare, progressive, and potentially life-threatening disease with no approved treatments. The data consist of 6.5-year outcomes for five adult patients with ASMD and 2-year outcomes in 20 pediatric patients, as well as the open-label extension from the Phase 3 ASCEND trial in adults. These data were presented at the 18th annual WORLDSymposiumTM held this week in San Diego, California. Alaa Hamed, MD, MPH, MBAGlobal Head of Medical Affairs, Rare Diseases, SanofiASMD can lead to progressive damage across multiple organ systems, and the risk of premature death often increases as symptoms become worse. Currently, patients living with this extremely rare disease have no treatment options. These collective findings demonstrate the promise of olipudase alfa to positively impact the progressive nature of ASMD, providing improvement that was observed early and did not diminish over an extended follow-up period up to 6.5 years." Long-term Data in Adult and Pediatric Patients with ASMD Source: West Corporation Feb 04, 2022: Banco Santander Press Release: Strong 2021 sales and business EPS growth enabling increased investment in R&D Strong 2021 sales and business EPS(1) growth enabling increased investment in R&D Paris, February 4, 2022 Q4 2021 sales growth of 4.1% and business EPS(1) growth of 9.8% at CER Full-year 2021 delivered 7.1% sales growth and 15.5% business EPS at CER Progress on Corporate Social Responsibility strategy Key milestone and regulatory achievements on R&D transformation 2022 financial outlook Sanofi Chief Executive Officer, Paul Hudson, commented: Sanofi has closed 2021 with a strong performance in the fourth quarter driven by high double-digit sales growth of Dupixent, which continues to set impressive record sales quarter after quarter. This quarter marks the first time Specialty Care has led our GBUs by sales, highlighting a significant milestone in our transformation. At the same time, Vaccines delivered another year of record influenza sales and is on a clear growth path as demonstrated at our recent Vaccines Day. In R&D, we continue to be relentless in our commitment to expand our innovative pipeline. Last quarter, Sanofi achieved a new milestone, a first in recent years, by moving seven molecules into Phase 1 and seven pipeline programs into Phase 2 trials, showcasing our success in rapidly advancing potentially transformative medicines. We further strengthened our R&D capabilities with a series of value creating M&A transactions in 2021. Our excellent financial performance validates our ability to increase profitability through improved product mix, supported by expense management and the reinvestment of savings behind our growth drivers, all of which puts us on a trajectory to achieving our 2022 financial targets. Source: West Corporation Feb 04, 2022: Banco Santander FDA approves Enjaymo (sutimlimab-jome), first treatment for use in patients with cold agglutinin disease FDA approves Enjaymo (sutimlimab-jome), first treatment for use in patients with cold agglutinin disease Enjaymo is the only approved treatment to decrease the need for red blood cell transfusion due to hemolysis, the destruction of red blood cells, in adults with cold agglutinin disease (CAD)Enjaymo addresses a serious and chronic unmet medical need for adults living with CAD, a rare blood disorder Paris, February 4, 2022. The U.S. Food and Drug Administration (FDA) has approved Enjaymo (sutimlimab-jome) to decrease the need for red blood cell transfusion due to hemolysis in adults with cold agglutinin disease (CAD). Enjaymo is the first and only approved treatment for people with CAD and works by inhibiting the destruction of red blood cells (hemolysis). Bill SiboldExecutive Vice President, Head of Specialty CareUntil now, people living with cold agglutinin disease havent had an approved treatment option to manage the constant destruction of red blood cells. Without healthy, viable red blood cells, a chain reaction of debilitating signs and symptoms can be triggered, starting with severe anemia. Enjaymo is the only approved treatment to inhibit red blood cell destruction in CAD and help stop the chain reaction from the start. CAD, a rare autoimmune hemolytic anemia, is caused by antibodies called cold agglutinins binding to the surface of red blood cells, which starts a process that causes the bodys immune system to mistakenly attack healthy red blood cells and cause their rupture (hemolysis). As red blood cells have the vital job of carrying oxygen throughout the body, patients with CAD may experience severe anemia, which can result in fatigue, weakness, shortness of breath, light-headedness, chest pain, irregular heartbeat, and other potential complications. CAD is a chronic and rare blood disorder that impacts the lives of an estimated 5,000 people in the U.S. Source: West Corporation Feb 03, 2022: Banco Santander Press Release: Sanofi unveils new corporate brand and logo unites the company under one purpose and a single identity Sanofi unveils new corporate brand and logo unites the company under one purpose and a single identity Paris, February 3, 2022. Sanofi today unveiled a new bold and unifying corporate brand that supports the modernization and transformation the company launched in December 2019. Over the last 50 years, Sanofi has grown into a diverse, global healthcare leader, with a rich heritage of patient-centric scientific discovery. This history includes the first treatments for many rare diseases and the establishment of standards of care in diabetes and cardiovascular disease. Sanofis commitment to public health has helped protect hundreds of millions of people from influenza every year for decades and pushed polio to the brink of eradication, while its scientific vision has led to breakthrough innovations in the treatment of inflammatory diseases. With roots in a variety of diverse companies, Sanofi is today the combination of many cultures, identities, and brands. Its new brand is rooted in this heritage and brings this diverse history together in a single common identity for the first time. This manifestation of the companys journey highlights an ambitious strategy for the future. Paul HudsonCEO of SanofiAs we approach the half century mark of our companys existence, we have undertaken the most important transformation and modernization in our history, said Paul Hudson, CEO of Sanofi. In 2019, we launched our Play to Win strategy, which focuses on applying our platform for innovation to produce first- and best-in-class treatments and vaccines. Our new brand is a natural and important next step in this journey and represents the integrated way in which the company will work to achieve our shared ambition to transform the practice of medicine. Source: West Corporation Jan 31, 2022: Banco Santander CHMP recommends approval of Dupixent (dupilumab) for children aged 6 to 11 years with severe asthma with type 2 inflammation CHMP recommends approval of Dupixent (dupilumab) for children aged 6 to 11 years with severe asthma with type 2 inflammation Recommendation based on pivotal trial that showed Dupixent significantly reduced severe asthma attacks and improved lung function in children aged 6 to 11Dupixent is the only biologic to show improved lung function in a randomized Phase 3 trial for children aged 6 to 11Data further reinforce well-established safety profile of Dupixent PARIS and TARRYTOWN, N.Y. January 31, 2022 - The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending to extend the approval of Dupixent (dupilumab) in the European Union (EU) to include add-on maintenance treatment for children aged 6 to 11 years with severe asthma with type 2 inflammation characterized by raised blood eosinophils and/or raised fractional exhaled nitric oxide (FeNO) who are inadequately controlled on two maintenance therapies. The European Commission is expected to announce a final decision on the Dupixent application in the coming months. The CHMP positive opinion is supported by Phase 3 data recently published in the New England Journal of Medicine showing that Dupixent added to standard of care significantly reduced the rate of severe asthma attacks and rapidly improved lung function within two weeks, with sustained improvement up to 52 weeks, in children with uncontrolled moderate-to-severe asthma. The safety results from the trial were generally consistent with the known safety profile of Dupixent in patients aged 12 years and older with uncontrolled moderate-to-severe asthma. Adverse events more commonly observed with Dupixent compared to placebo included injection site reactions, viral upper respiratory tract infections and eosinophilia. Helminth infections were also more commonly observed with Dupixent compared to placebo in patients aged 6 to11 years. Asthma is one of the most common chronic diseases in children. Up to 85% of children with asthma may have type 2 inflammation and are more likely to have higher disease burden. Despite treatment with current standard-of-care inhaled corticosteroids (ICS) and bronchodilators, these children may continue to experience serious symptoms such as coughing, wheezing and difficulty breathing. Severe asthma may impact children's developing airways and cause potentially life-threatening exacerbations. Children with severe asthma also may require the use of multiple courses of systemic corticosteroids that carry significant risks. Uncontrolled severe asthma can interfere with day-to-day activities, like sleeping, attending school and playing sports. Source: West Corporation Jan 19, 2022: Banco Santander Second positive Phase 3 Dupixent (dupilumab) trial confirms significant improvements for patients with prurigo nodularis Second positive Phase 3 Dupixent (dupilumab) trial confirms significant improvements for patients with prurigo nodularis Dupixent is the first and only medicine to demonstrate positive Phase 3 results in prurigo nodularis, confirming the potential benefit of targeting IL-4 and IL-13, central drivers of type 2 inflammation, to address itch and skin lesionsData confirm results from first Phase 3 trial, with 60% of Dupixent patients meeting the primary endpoint of itch reduction compared to 18% of placebo at 24 weeksAdditionally, nearly three times as many Dupixent patients experienced reduced skin lesionsData continue to support well-established safety profile of Dupixent Data to be submitted to regulatory authorities starting in H1 PARIS and TARRYTOWN, N.Y. January 19, 2022 A second Phase 3 trial evaluating Dupixent (dupilumab) in adults with uncontrolled prurigo nodularis, a chronic type 2 inflammatory skin disease, met its primary and key secondary endpoints, showing it significantly reduced itch and skin lesions compared to placebo at 24 weeks in this investigational setting. The data confirm the positive results that were previously reported from the Phase 3 PRIME2 trial and will be submitted to regulatory authorities around the world starting in the first half of this year. The impact of prurigo nodularis on quality of life is one of the highest among inflammatory skin diseases due to the extreme itch. These results strengthen our understanding of the underlying biology of prurigo nodularis and are encouraging as we seek to help patients severely impacted by symptoms like unbearable itch, skin lesions, stinging and burning, says Naimish Patel, M.D, Head of Global Development, Immunology and Inflammation at Sanofi. We are committed to researching the science behind type 2 inflammation to advance and shift perceptions in a number of inflammatory skin diseases that are not well-understood. The decision to accelerate directly into a Phase 3 clinical trial for prurigo nodularis was driven by our conviction that type 2 inflammation is a key driver of this highly pruritic disease and underscores our commitment to quickly bring novel treatments to patients who are in urgent need of new options. People with prurigo nodularis can experience intense, persistent itch, with thick skin lesions (called nodules) that can cover most of the body. It is often described as painful with burning, stinging and tingling of the skin. The disease can also negatively affect mental health, activities of daily living and social interactions. High-potency topical steroids are commonly prescribed but are associated with safety risks if used long-term. There are approximately 75,000 people in the U.S. who are unable to control their disease with topical steroids and otherwise do not have an approved treatment option. Source: West Corporation Jan 07, 2022: Banco Santander Exscientia and Sanofi establish strategic research collaboration to develop AI-driven pipeline of precision-engineered medicines Exscientia and Sanofi establish strategic research collaboration to develop AI-driven pipeline of precision-engineered medicines PARIS, OXFORD, and BOSTON January 7, 2022 Sanofi and Exscientia announced today a groundbreaking research collaboration and license agreement to develop up to 15 novel small molecule candidates across oncology and immunology, leveraging Exscientias end-to-end AI-driven platform utilizing actual patient samples. The companies have been working together since 2016 and in 2019, Sanofi in-licensed Exscientias novel bispecific small molecule candidate capable of targeting two distinct targets in inflammation and immunology. We look forward to deepening our work with Exscientia, a leader in leveraging AI to modernize all aspects of drug discovery and development, said Frank Nestle, Global Head of Research and Chief Scientific Officer, Sanofi. Sanofis collaboration with Exscientia aims to transform how we discover and develop new small molecule medicines for cancer and immune-mediated diseases. Application of sophisticated AI and machine learning methods will not only shorten drug discovery timelines, but will also help to design higher quality and better targeted medicines for patients. Exscientia and Sanofi will collaborate to identify and select target projects, leveraging Exscientias personalised medicine platform. The platform enables a patient-first approach through integrating primary human tissue samples into early target and drug discovery research. By doing so, Exscientia scientists can integrate patient, disease, and clinically relevant data into decisions on potential new medicine candidates earlier in the drug creation process. In addition to target discovery, Exscientia will lead small molecule drug design and lead optimization activities up to development candidate nomination, with Sanofi assuming responsibility for preclinical and clinical development, manufacturing and commercialization. Source: West Corporation Jan 04, 2022: Banco Santander Availability of the Q4 2021 Memorandum for modelling purposes Paris, France aEUR" January 4, 2022 - Sanofi announced today that its Q4 2021 Memorandum for modelling purposes is available on the "Investors" page of the company's website: https://www.sanofi.com/en/investors/financial-results-and-events/financial-results/Q4-results-2021 As for each quarter, Sanofi prepared this document to assist in the financial modelling of the Group's quarterly results. This document includes a reminder on various non-comparable items and exclusivity losses as well as the foreign currency impact and share count. Sanofi's fourth-quarter 2021 results will be published on February 4, 2022. Source: West Corporation 2021 Dec 15, 2021: Banco Santander Sanofi and GSK announce positive preliminary booster data for their COVID-19 vaccine candidate and continuation of Phase 3 trial per independent Monitoring Board recommendation Sanofi and GSK announce positive preliminary booster data for their COVID-19 vaccine candidate and continuation of Phase 3 trial per independent Monitoring Board recommendation Positive booster data show that neutralizing antibodies increased across all primary vaccines received (mRNA or adenovirus) in a 9- to 43-fold range and for all age groups tested, with a good safety and tolerability profilePhase 3 trial continues to accrue number of events needed for analysis as populations around the world are increasingly exposed to COVID-19 variants; results expected in Q1, 2022Companies intend to file booster data with regulatory authorities following the Phase 3 results PARIS December 15, 2021 - Sanofi and GSK announced today that a single booster dose of their recombinant adjuvanted COVID-19 vaccine candidate delivered consistently strong immune responses. Preliminary results from the VAT0002 clinical trial investigating the safety and immunogenicity of the booster showed neutralizing antibodies increased 9- to 43-fold regardless of the primary vaccine received (AstraZeneca, Johnson & Johnson, Moderna, Pfizer/BioNTech) and for all age groups tested. The booster was well tolerated, with a safety profile similar to currently approved COVID-19 vaccines. This is the most comprehensive booster trial to date to explore boosting across different vaccine technologies used for primary vaccination. The ongoing global Phase 3 trial, VAT0008, includes regular reviews by an independent Data Safety Monitoring Board (DSMB). During its last review, the DSMB identified no safety concerns and recommended the trial to continue into early 2022 to accrue more data. Source: West Corporation Nov 18, 2021: Banco Santander Sanofi invests $180 million equity in Owkins artificial intelligence and federated learning to advance oncology pipeline Sanofi invests $180 million equity in Owkins artificial intelligence and federated learning to advance oncology pipeline Combined efforts will work to build robust disease models while preserving privacy of large data sets from various research institutions and hospitals Collaboration to focus on four types of cancer PARIS November 18, 2021 Sanofi announced today an equity investment of $180 million and a new strategic collaboration with Owkin comprised of discovery and development programmes in four exclusive types of cancer, witha total payment of $90 million for three years plus additional research milestone-based payments. Owkin, an artificial intelligence (AI) and precision medicine company, builds best-in-class predictive biomedical AI models and robust data sets. With the ambition to optimize clinical trial design and detect predictive biomarkers for diseases and treatment outcomes, this collaboration will support Sanofis growing oncology portfolio in core areas such as lung cancer, breast cancer and multiple myeloma. To accelerate medical research with AI in a privacy-preserving way, Owkin has assembled a global research network powered by federated learning, which allows data scientists to securely connect to decentralized, multi-party data sets and train AI models without having to pool data. This approach will complement Sanofis emerging strength in oncology, as the companys scientists apply cutting-edge technology platforms to design potentially life-transforming medicines for cancer patients worldwide. Source: West Corporation Oct 28, 2021: Banco Santander Sanofi : Strong Q3 performance drives guidance upgrade to around 14% business EPS growth at CER(1) Paris, October 28, 2021 Strong Q3 performance drives guidance upgrade to around 14% business EPS growth at CER(1) Q3 2021 sales grew double digit to 10.4 billion (up 10.1%) due to strong growth from Dupixent, Vaccines and CHC Q3 2021 business EPS(2) growth of 19.1% at CER driven by sales performance and efficiencies Progress on Corporate Social Responsibility strategy Key milestone and regulatory achievements on R&D transformation Full-year 2021 business EPS guidance revised upward(1) Sanofi Chief Executive Officer, Paul Hudson, commented: Sanofi has delivered outstanding financial results in the third quarter. Double-digit sales growth in the period was driven by the remarkable performance of Dupixent, record sales of Vaccines and business momentum in Consumer Healthcare, all in line with our strategic priorities. As a result of our sales performance and strong earnings, we have upgraded our full-year EPS guidance growth to around 14% at CER. In R&D, our growing pipeline of potentially transformative therapies has progressed, including the most recent positive readouts for Dupixent in Eosinophilic esophagitis and Prurigo nodularis as well as the U.S. approval and launch of Nexviazyme in Pompe disease. With higher R&D investment behind our pipeline assets and the two targeted bolt-on acquisitions of Translate Bio and Kadmon, we have further increased our commitment to bring innovative medicines to patients and drive future growth. Aligned with our contract with society and leading up to COP 26, we have set ourselves new ambitious ESG targets to reduce carbon emissions and accelerate our actions in fighting global climate change. Source: West Corporation Oct 25, 2021: Banco Santander Second Dupixent (dupilumab) Phase 3 eosinophilic esophagitis trial to demonstrate significant disease improvements, underscoring role of type 2 inflammation in this complex disease Second Dupixent (dupilumab) Phase 3 eosinophilic esophagitis trial to demonstrate significant disease improvements, underscoring role of type 2 inflammation in this complex disease Dupixent 300 mg weekly significantly improved the ability to swallow and reduced eosinophils in the esophagus compared to placebo, reinforcing positive results from first Phase 3 trialDupixent is the first and only biologic to show positive, clinically meaningful Phase 3 results in these patientsData continue to support well-established safety profile of Dupixent Regulatory filings planned for 2022 PARIS and TARRYTOWN, N.Y. October 25, 2021 Results from a second Phase 3 trial assessing the investigational use of Dupixent (dupilumab) in patients 12 years and older with eosinophilic esophagitis (EoE) demonstrated that the trial met its co-primary endpoints in patients taking Dupixent 300 mg weekly, showing significant improvements in clinical (Dysphagia Symptom Questionnaire) and histologic disease measures compared to placebo. EoE is a chronic and progressive type 2 inflammatory disease that damages the esophagus and impairs the ability to swallow. In September 2020, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to Dupixent for the treatment of patients 12 years and older with EoE. Results from the extended active treatment period (up to 52 weeks) of a previously reported Phase 3 trial studying Dupixent 300 mg weekly for 24 weeks were recently presented at the United European Gastroenterology Week Virtual 2021 congress. Data from the clinical trial program will be submitted to regulatory authorities by 2022. Source: West Corporation Oct 22, 2021: Banco Santander Dupixent (dupilumab) is the first biologic to significantly reduce itch and skin lesions in Phase 3 trial for prurigo nodularis, demonstrating the role of type 2 inflammation in this disease Dupixent (dupilumab) is the first biologic to significantly reduce itch and skin lesions in Phase 3 trial for prurigo nodularis, demonstrating the role of type 2 inflammation in this disease Pivotal trial met primary and all key secondary endpointsDupixent significantly reduced itch at 12 weeks, and nearly three times as many Dupixent patients experienced reductions in both itch and skin lesions at 24 weeksData reinforce impact of targeting IL-4 and IL-13, key and central drivers of type 2 inflammation, to address itch and skin lesionsSixth disease in a Phase 3 trial for Dupixent that reinforces well-established safety profile PARIS and TARRYTOWN, N.Y. October 22, 2021 - A pivotal Phase 3 trial evaluating Dupixent (dupilumab) in adults with uncontrolled prurigo nodularis, a chronic type 2 inflammatory skin disease that causes extreme itch and skin lesions, met its primary and all key secondary endpoints, showing that Dupixent significantly reduced itch and skin lesions compared to placebo in this investigational setting. The impact of uncontrolled prurigo nodularis on quality of life is one of the highest among inflammatory skin diseases with intense, chronic itch. We are encouraged that patients in this trial experienced a significant reduction in itch and skin lesions, especially given that prior to enrollment nearly all patients had severe itch and nearly 40% had 100 or more nodules covering their body, said John Reed, M.D., Ph.D., Global Head of Research and Development at Sanofi. These data are an important step forward in furthering our knowledge of the role that targeting IL-4 and IL-13 can play in the treatment of skin diseases that cause extreme itch. We are committed to continuing to leverage the robust Dupixent clinical program to transform the understanding of the science behind a number of type 2 inflammatory diseases and look forward to presenting the full results at a future medical congress. Source: West Corporation Oct 20, 2021: Banco Santander FDA expands approval of Dupixent (dupilumab) to include children aged 6 to 11 years with moderate-to-severe asthma FDA expands approval of Dupixent (dupilumab) to include children aged 6 to 11 years with moderate-to-severe asthma Dupixent is the only biologic medicine to improve lung function in children aged 6 to 11 years in a randomized Phase 3 trial, supporting potential as a best-in-class option Only biologic medicine approved for children with oral corticosteroid-dependent asthmaData reinforce well-established safety profile of Dupixent PARIS and TARRYTOWN, N.Y. October 20, 2021 - The U.S. Food and Drug Administration (FDA) has approved Dupixent (dupilumab) as an add-on maintenance treatment of patients aged 6 to 11 years with moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid-dependent asthma.This FDA approval brings new hope for children who may be suffering from life-threatening asthma attacks and poor lung function, affecting their ability to breathe, potentially into adulthood, says Naimish Patel, M.D. Head of Global Development in Immunology and Inflammation at Sanofi. Dupixent has helped to make a difference to the lives of many patients and families across three diseases with underlying type 2 inflammation, with more than 300,000 patients treated globally. We now have the opportunity to offer a safe and effective option to children as young as 6 years of age living with certain types of moderate-to-severe asthma.Asthma is one of the most common chronic diseases in children. Approximately 75,000 children aged 6 to 11 years live with the uncontrolled moderate-to-severe form of the disease in the U.S., with many more worldwide. Despite treatment with current standard-of-care inhaled corticosteroids and bronchodilators, these children may continue to experience serious symptoms such as coughing, wheezing and difficulty breathing. They also may require the use of multiple courses of systemic corticosteroids that carry significant risks. Despite available treatments, moderate-to-severe asthma can severely impact childrens developing airways, causing sleepless nights, persistent coughing and wheezing, and potentially life-threatening exacerbations that require the use of systemic steroids that can negatively affect growth, says George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer at Regeneron. This approval means that Dupixent, a first-of-its-kind treatment with a well-established efficacy and safety profile, can now be used by younger children with certain types of moderate-to-severe asthma in the U.S. In our pivotal trial, Dupixent helped children aged 6 to 11 years breathe better, suffer fewer asthma attacks and improve health-related quality of life. We also continue to study Dupixent in patients with other dermatologic, respiratory and gastrointestinal conditions, where type 2 inflammation may play a role. Source: West Corporation Oct 13, 2021: Banco Santander New long-term data reinforcing promising safety and efficacy profile of brain-penetrant tolebrutinib presented at ECTRIMS 2021 New long-term data reinforcing promising safety and efficacy profile of brain-penetrant tolebrutinib presented at ECTRIMS 2021 One-year results from Phase 2b extension study of brain-penetrant tolebrutinib showed 98 percent of patients remained on treatmentAfter 48 weeks, mean MRI lesion activity remained low in patients who started on or switched to tolebrutinib 60mgData from in vitro studies in human microglia extended previous observations that BTK-dependent inflammatory signalling can be modulated by tolebrutinib PARIS October 13, 2021 - Sanofis investigational oral Brutons tyrosine kinase (BTK) inhibitor, tolebrutinib, demonstrated favorable one-year tolerability in a Phase 2b long-term extension study (LTS) in patients with relapsing forms of multiple sclerosis (RMS). The results showed that after 48 weeks of treatment, tolebrutinib reduced multiple sclerosis (MS) disease activity as measured by magnetic resonance imaging (MRI). These data are being presented as ePosters at the 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) on October 13 15, 2021. Understanding the ability of a brain-penetrant therapy to slow disability accumulation has the potential to bring new hope to people suffering from difficult-to-treat MS. For nearly two decades, Sanofi has been unwavering in its efforts to accelerate research and treatment options for these patients, says Erik Wallstrom, M.D., Ph.D., Therapeutic Area Head, Neurology Development at Sanofi. Source: West Corporation Sep 30, 2021: Banco Santander New, late-breaking data at EADV highlights emerging clinical profile of amlitelimab (formerly KY1005) in adults with inadequately controlled moderate-to-severe atopic dermatitis New, late-breaking data at EADV highlights emerging clinical profile of amlitelimab (formerly KY1005) in adults with inadequately controlled moderate-to-severe atopic dermatitis Low dose arm of the study met the co-primary endpoints of percent change in Eczema Area and Severity Index (EASI) score from baseline, and incidence of treatment-emergent adverse events, through week 16 First trial to assess the effects of blocking OX40-Ligand, a key immune system regulator, in patients with moderate-to-severe atopic dermatitisData support amlitelimab as a potential first-in-class anti-OX40-Ligand monoclonal antibody for adults with moderate-to-severe atopic dermatitis PARIS September 30, 2021 Positive results from a Phase 2a study evaluating the safety and efficacy of amlitelimab, a human monoclonal antibody targeting key immune system regulator OX40-Ligand, were presented as a late-breaker today at the European Academy of Dermatology and Venerology (EADV) 2021 Virtual Congress. In the study, amlitelimab showed significant improvements in signs and symptoms of moderate-to-severe atopic dermatitis with a well-tolerated safety profile in adults whose disease cannot be adequately controlled with topical medications or for whom topical medications are not a recommended treatment approach."While new options are increasingly available for the treatment of atopic dermatitis, individual patients have different responses to therapies and therefore require different solutions," said Professor Stephan Weidinger, M.D., Ph.D., Vice Director, Professor, Department of Dermatology and Allergy, University Hospital Schleswig-Holstein. In the Phase 2a study presented at EADV, amlitelimab was shown to meaningfully improve the signs and symptoms of atopic dermatitis patients with moderate to severe disease with an unremarkable safety profile. These early results are exciting, and we look forward to seeking confirmatory data in future amlitelimab clinical trials. In this Phase 2a double-blind, placebo-controlled study, participants were randomized to either intravenous amlitelimab-low dose (LD) (n=29), intravenous amlitelimab-high dose (HD) (n=30) or placebo (n=29) and were treated every four weeks over a 12-week period. Eligible patients included adults with moderate-to-severe atopic dermatitis whose disease is inadequately controlled with topical therapies such as corticosteroids, or where such therapies were not advisable. Source: West Corporation Sep 28, 2021: Banco Santander Sanofi announces positive Phase 1/2 study interim results for its first mRNA-based vaccine candidate Sanofi announces positive Phase 1/2 study interim results for its first mRNA-based vaccine candidate High seroconversion across the three dosages tested and comparable tolerability to other unmodified mRNA COVID-19 vaccinesNow accelerating transformation of acquired platform to modified mRNA and targeting a modified quadrivalent flu mRNA vaccine in the clinic in 2022 PARIS September 28, 2021 Positive interim results from a Phase 1/2 study1 of Sanofis mRNA-based COVID-19 vaccine candidate confirm the potential of recently-acquired Translate Bios messenger RNA (mRNA) and lipid nanoparticle (LNP) platform and support Sanofis mRNA strategy. The initial data from Phase 1/2 showed neutralizing antibody seroconversion (defined as 4-fold increase vs baseline) in 91% to 100% of study participants, two weeks after a second injection, across all 3 dosages tested. No safety concern has been observed and the tolerability profile is comparable to that of other unmodified mRNA COVID-19 vaccines. Further data from this first study of Sanofis mRNA platform will be presented at a later date. We are happy to see those positive initial results. We have made an impressive move just 9 months after the worldwide proof of concept of mRNA vaccines and only 17 since we started this first mRNA vaccine project, says Jean-Francois Toussaint, Global Head of Research and Development, Sanofi Pasteur. These results will clearly help inform the path forward for our mRNA development programs. Today, we have a promising mRNA platform, which were taking to the next level in development, including moving to modified mRNA, and against other diseases, including flu. Source: West Corporation Sep 24, 2021: Banco Santander Sanofi: Availability of the Q3 2021 Memorandum for modelling purposes Availability of the Q3 2021 Memorandum for modelling purposes Paris, France September 24, 2021 - Sanofi announced today that its Q3 2021 Memorandum for modelling purposes is available on the "Investors" page of the company's website: https://www.sanofi.com/en/investors/financial-results-and-events/financial-results/Q3-results-2021 As for each quarter, Sanofi prepared this document to assist in the financial modelling of the Group's quarterly results. This document includes a reminder on various non-comparable items and exclusivity losses as well as the foreign currency impact and share count. Sanofi's third-quarter 2021 results will be published on October 28, 2021. About Sanofi Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Media Relations ContactsSandrine GuendoulTel.: +33 (0)6 25 09 14 25sandrine.guendoul@sanofi.com Media Relations main line:Tel.: +33 (0)1 53 77 46 46mr@sanofi.com Investor Relations ContactsInvestor Relations team:Tel.: +33 (0)1 53 77 45 45investor.relations@sanofi.comhttps://www.sanofi.com/en/investors/contact Sanofi Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words expects, anticipates, believes, intends, estimates, plans and similar expressions. Although Sanofis management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofis ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. Any material effect of COVID-19 on any of the foregoing could also adversely impact us. This situation is changing rapidly and additional impacts may arise of which we are not currently aware and may exacerbate other previously identified risks. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under Risk Factors and Cautionary Statement Regarding Forward-Looking Statements in Sanofis annual report on Form 20-F for the year ended December 31, 2020. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. Source: West Corporation Sep 21, 2021: Banco Santander New Dupixent (dupilumab) data in patients as young as 6 years old with moderate-to-severe atopic dermatitis to be presented at WCPD and EADV New Dupixent (dupilumab) data in patients as young as 6 years old with moderate-to-severe atopic dermatitis to be presented at WCPD and EADV More than 30 presentations reinforce the role of Dupixent in targeting IL-4 and IL-13, key drivers of the type 2 inflammation underlying atopic dermatitis in children, adolescents, and adults Results provide insight into the clinical and real-world experience of Dupixent on key disease measures including itch, disease severity, sleep and anxietyDupixent presentations include longest duration of data for any biologic medicine in adults with moderate-to-severe atopic dermatitis, with results up to 3.5 years PARIS and TARRYTOWN, N.Y. September 21, 2021 - New Dupixent (dupilumab) analyses in patients as young as 6 years old with moderate-to-severe atopic dermatitis will be presented at the 14th World Congress of Pediatric Dermatology Annual Congress (WCPD) from September 22-25 and the 30th European Academy of Dermatology and Venereology Congress (EADV) from September 29-October 2. The extensive portfolio of Dupixent data being showcased at these global congresses addresses the impact of Dupixent on the signs, symptoms and quality of life in patients as young as six years old with moderate-to-severe atopic dermatitis and reinforces the need for studying the long-term safety and efficacy of treatments targeting type 2 inflammation, said Naimish Patel, M.D. Head of Global Development in Immunology and Inflammation at Sanofi. In addition, we look forward to presenting key findings from our global Atopic Dermatitis-GAP survey and Quality of Care Report, which demonstrate our commitment to disease education and fostering new conversations about best practices for patient care within the atopic dermatitis community Source: West Corporation Sep 19, 2021: Banco Santander ESMO late-breaking data show Libtayo (cemiplimab) and chemotherapy first-line treatment combination significantly improved overall survival in patients with advanced NSCLC ESMO late-breaking data show Libtayo (cemiplimab) and chemotherapy first-line treatment combination significantly improved overall survival in patients with advanced NSCLC Phase 3 trial met its primary and key secondary endpointsLibtayo is one of two PD-(L)1 inhibitors to demonstrate positive Phase 3 results in first-line advanced NSCLC irrespective of histology both as monotherapy and in combination with chemotherapyTrial enrolled patients with varied baseline characteristics, including squamous and non-squamous histologies and all PD-L1 expression levels; 84% had an ECOG 1 performance status (reduced daily functioning) PARIS and TARRYTOWN, N.Y. September 19, 2021 - Positive Phase 3 results for Sanofi and Regeneron Pharmaceuticals, Inc.s Libtayo (cemiplimab) combination treatment were presented today during a late-breaking session at the European Society for Medical Oncology Virtual Congress 2021. The trial, which met its primary overall survival (OS) endpoint and all key secondary endpoints, assessed the investigational use of PD-1 inhibitor Libtayo in combination with a physicians choice of platinum-doublet chemotherapy (Libtayo combination) in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) irrespective of histology and across all PD-L1 expression levels, compared to chemotherapy alone. These results were also achieved in a patient population with varied baseline characteristics and will form the basis of regulatory submissions, including in the U.S. and European Union (EU). Libtayo added to chemotherapy significantly improved patient outcomes, extending median overall survival to 22 months and median progression-free survival to 8 months, said Miranda Gogishvili, M.D., an oncologist at the High Technology Medical Center University Clinic, in Tbilisi, Georgia and a trial investigator. Exploratory analyses showed that survival improvements were seen across squamous and non-squamous histologies and in patients with reduced daily functioning, with 43% of patients having squamous disease and 84% having an ECOG 1 performance status. Furthermore, in another exploratory analysis, the Libtayo combination helped delay deterioration in patient-reported quality of life and pain symptoms.In the overall population, patients treated with the Libtayo combination (n=312) experienced significant improvements compared to those receiving chemotherapy alone (n=154), including a: Source: West Corporation Sep 09, 2021: Banco Santander Sanofi provides update on Phase 3 study evaluating rilzabrutinib for the treatment of pemphigus Sanofi provides update on Phase 3 study evaluating rilzabrutinib for the treatment of pemphigus PARIS September 9, 2021 The Phase 3 PEGASUS trial evaluating rilzabrutinib to treat pemphigus, a rare autoimmune skin condition, did not meet its primary or key secondary endpoints. Rilzabrutinibs safety profile remained consistent with previous results and no new safety signals were identified. The Phase 3 study, which is the first placebo-controlled trial of a BTK inhibitor in pemphigus, enrolled adult patients with moderate-to-severe pemphigus vulgaris or pemphigus foliaceus. The primary endpoint was complete remission from weeks 29 to 37 with minimal doses of corticosteroids (10/mg day). Complete remission was defined as the absence of new and established skin lesions. Results show the proportion of patients meeting the primary endpoint on rilzabrutinib was not significantly different from placebo. Sanofi is continuing to evaluate the data and plans to share detailed findings at a future medical meeting. While these results are disappointing, we believe the rilzabrutinib clinical program holds great potential to address the unmet treatment needs of people living with immune-mediated diseases, said Naimish Patel, Head of Global Development, Immunology and Inflammation. Our mission is to improve outcomes by exploring new scientific approaches and novel therapies to advance the standard of care. We are committed to investigating rilzabrutinib further and progressing our clinical programs forward to deliver new treatment options for patients. Source: West Corporation Aug 30, 2021: Banco Santander Dupixent (dupilumab) pivotal trial meets all primary and secondary endpoints becoming first biologic medicine to significantly reduce signs and symptoms of moderate-to-severe atopic dermatitis in children as young as 6 months Dupixent (dupilumab) pivotal trial meets all primary and secondary endpoints becoming first biologic medicine to significantly reduce signs and symptoms of moderate-to-severe atopic dermatitis in children as young as 6 months Dupixent rapidly improved symptoms after first dose, improving itch in one week and skin clearance in two weeksMore than seven times as many patients treated with Dupixent plus topical corticosteroids (TCS) achieved clear or almost clear skin compared to TCS alone at Week 16Dupixent plus TCS reduced overall disease severity by 70% and itch by 49%Results reinforce well-established safety profile of Dupixent - the first ever biologic medicine for atopic dermatitis currently approved for patients as young 6 years old PARIS and TARRYTOWN, N.Y. August 30, 2021 - A pivotal Phase 3 trial evaluating Dupixent (dupilumab) for the treatment of children aged 6 months to 5 years with moderate-to-severe atopic dermatitis, a chronic type 2 inflammatory disease, met its primary and all secondary endpoints. The data show adding Dupixent to standard of care topical corticosteroids (TCS) significantly reduced overall disease severity and improved skin clearance, itch, and health-related quality of life measures at 16 weeks compared to TCS alone. Dupixent is the first biologic medicine to show positive results in this young population and remains the only approved biologic medicine in patients 6 years and older with uncontrolled moderate-to-severe atopic dermatitis. The data reinforce the well-established efficacy and safety profile of Dupixent in other age groups including a lower observed rate of skin infection in the Dupixent group compared with placebo. During the 16-week treatment period Dupixent patients were 50% less likely to experience a skin infection (12% Dupixent, 24% placebo), and the total number of infections was nearly 70% lower (11 Dupixent, 34 placebo). These results add to the extensive LIBERTY AD clinical program the largest Phase 3 clinical trial program in atopic dermatitis involving approximately 3,500 children, adolescents, and adults to date. Source: West Corporation Aug 06, 2021: Banco Santander FDA approves Nexviazyme (avalglucosidase alfa-ngpt), an important new treatment option for late-onset Pompe disease FDA approves Nexviazyme (avalglucosidase alfa-ngpt), an important new treatment option for late-onset Pompe disease Approval is based on positive Phase 3 data demonstrating improvements in key disease burden measures and establishing its safety profile Nexviazyme specifically targets the M6P receptor, the key pathway for enzyme replacement therapy, to effectively clear glycogen build-up in muscle cells PARIS August 6, 2021 - The U.S. Food and Drug Administration (FDA) has approved Nexviazyme (avalglucosidase alfa-ngpt) for the treatment of patients one year of age and older with late-onset Pompe disease, a progressive and debilitating muscle disorder that impairs a persons ability to move and breathe. Nexviazyme is an enzyme replacement therapy (ERT) designed to specifically target the mannose-6-phosphate (M6P) receptor, the key pathway for cellular uptake of enzyme replacement therapy in Pompe disease. Nexviazyme has been shown in clinical trials to provide patients with improvements in respiratory function and walking distance. Pompe disease is a debilitating and progressive condition that significantly inhibits mobility and breathing, said Bill Sibold, Executive Vice President of Sanofi Genzyme. For decades, weve made it our responsibility to research how to target the M6P receptor, the key pathway for cellular uptake of enzyme replacement therapy. Nexviazyme is a potential new standard of care for people living with late-onset Pompe disease and delivers on our promise to pursue medicines for patients living with rare diseases.Pompe disease affects an estimated 3,500 people in the United States and can present as infantile-onset Pompe disease (IOPD), the most severe form of Pompe disease with rapid onset in infancy, and late-onset Pompe disease (LOPD), which progressively damages muscles over time. LOPD symptoms may present at any age. However, due to the wide spectrum of clinical presentations and progressive nature of the disease, it can take seven to nine years before patients receive an accurate diagnosis. As the disease progresses, people with LOPD may require mechanical ventilation to help with breathing or a wheelchair to assist with mobility. Targeted delivery to clear glycogen in muscle cells Source: West Corporation Aug 05, 2021: Banco Santander Phase 3 trial of Libtayo (cemiplimab) combined with chemotherapy stopped early due to significant improvement in overall survival in patients with first-line advanced non-small cell lung cancer Phase 3 trial of Libtayo (cemiplimab) combined with chemotherapy stopped early due to significant improvement in overall survival in patients with first-line advanced non-small cell lung cancer Libtayo combined with chemotherapy increased median overall survival from 13 to 22 months, leading to a 29% reduction in the risk of deathTrial enrolled patients with locally advanced and metastatic disease with squamous or non-squamous histology, and across all PD-L1 expression levelsLibtayo has now demonstrated improved overall survival as a monotherapy or in combination with chemotherapy in first-line advanced non-small cell lung cancer PARIS and TARRYTOWN, NY August 5, 2021 - The Phase 3 trial of Sanofi and Regenerons PD-1 inhibitor Libtayo in combination with platinum-doublet chemotherapy was stopped early after meeting its overall survival (OS) primary endpoint in patients with advanced non-small cell lung cancer (NSCLC). Adding Libtayo to chemotherapy significantly improved OS, compared to chemotherapy alone, in the trial that enrolled patients with metastatic or locally advanced disease and tumors with either squamous or non-squamous histology and across all PD-L1 expression levels. These data are planned to form the basis of regulatory submissions in the U.S. and European Union.Libtayo in combination with chemotherapy increased median overall survival to 22 months in patients with advanced non-small cell lung cancer, compared to 13 months with chemotherapy alone, said Miranda Gogishvili, M.D., an oncologist at the High Technology Medical Center, University Clinic, in Tbilisi, Georgia and a trial investigator. Notably, the Phase 3 trial enrolled patients with a variety of challenging-to-treat disease characteristics, as well as those with locally advanced disease. These data add to the growing body of evidence supporting Libtayo in advanced non-small cell lung cancer, which also include the pivotal results for Libtayo monotherapy in cases of high PD-L1 expression. The decision to stop the trial early was based on a recommendation by the Independent Data Monitoring Committee (IDMC) during a protocol-specified interim analysis. In this top-line initial analysis of 466 patients, combining Libtayo with chemotherapy reduced the risk of death by 29% compared to chemotherapy alone (hazard ratio: 0.71; 95% confidence interval [CI]: 0.53-0.93; p=0.014). Median OS was 22 months (95% CI: 16 months to not evaluable) for Libtayo and chemotherapy, and 13 months (95% CI: 12 to 16 months) for chemotherapy alone. No new Libtayo safety signals were identified in the IDMC analysis, and additional detailed efficacy and safety data will be presented at an upcoming medical meeting. Source: West Corporation Jul 29, 2021: Banco Santander Dupixent (dupilumab) significantly improved itch and hives in patients with chronic spontaneous urticaria, a step forward in demonstrating the role of type 2 inflammation in these patients Dupixent (dupilumab) significantly improved itch and hives in patients with chronic spontaneous urticaria, a step forward in demonstrating the role of type 2 inflammation in these patients Fifth disease that Dupixent has demonstrated positive pivotal resultsPhase 3 trial met its primary endpoints and all key secondary endpoints at 24 weeks, showing Dupixent nearly doubled reduction in itch and urticaria activity scores CSU results further demonstrate the potential of targeting IL-4 and IL-13 via IL-4Ra blockade in improving diseases with components of type 2 inflammationApproximately 300,000 people in the U.S. have moderate to severe CSU that does not respond adequately to antihistamines alone Data continue to support well-established safety profile of Dupixent PARIS and TARRYTOWN, N.Y. July 29, 2021 - A pivotal Phase 3 trial evaluating Dupixent (dupilumab) in patients with moderate-to-severe chronic spontaneous urticaria (CSU), an inflammatory skin disease, met its primary endpoints and all key secondary endpoints at 24 weeks. Adding Dupixent to standard-of-care antihistamines significantly reduced itch and hives for biologic-naive patients, compared to those treated with antihistamines alone (placebo) in Study A (the first of two trials) of the LIBERTY CUPID clinical program. The chronic nature of CSU, coupled with intense itch, causes both a physical and emotional burden on people who have not found an effective treatment, said John Reed, M.D., Ph.D., Global Head of Research and Development at Sanofi. This is the fifth inflammatory disease in which Dupixent has demonstrated a significant improvement in symptoms and disease manifestations in Phase 3 pivotal studies. The success of this trial underscores the agility of our clinical operations team considering the pandemic conditions and underscores our ability to deliver on an aggressive timeline for addressing a significant unmet need for this patient population. Source: West Corporation Jul 29, 2021: Banco Santander Online availability of Sanofis half-year financial report for 2021 Online availability of Sanofis half-year financial report for 2021 PARIS July 29, 2021 - Sanofi announces that its half-year financial report for the period ending June 30, 2021 is now available and has been filed with the French market regulator Autorite des marches financiers (AMF) and submitted to the U.S. Securities and Exchange Commission (SEC) under form 6-K. This document may be found on the companys corporate website: www.sanofi.com and downloaded from the Investors page, under the heading Regulated Information in France. About Sanofi Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Media Relations Contacts Ashleigh KossTel: +1 (908) 205-2572Ashleigh.Koss@sanofi.com Sandrine GuendoulTel.: +33 (0)6 25 09 14 25MR@sanofi.com Nicolas KressmannTel.: +1 (732) 532-5318Nicolas.Kressmann@sanofi.com Investor Relations Contacts ParisEva Schaefer-JansenArnaud DelepineNathalie Pham Investor Relations Contacts North AmericaFelix LauscherFara BerkowitzSuzanne Greco Tel.: +33 (0)1 53 77 45 45 investor.relations@sanofi.comhttps://www.sanofi.com/en/investors/contact Source: West Corporation Jul 29, 2021: Banco Santander Sales growth accelerated - Full-year guidance raised Paris, July 29, 2021 Sales growth accelerated - Full-year guidance raised Q2 2021 sales grew double digit to 8.7 billion (up 12.4% at CER) mainly driven by Dupixent and Vaccines Q2 2021 business EPS(1) growth of 16.4% at CER driven by sales performance and efficiencies Progress on implementation of the Corporate Social Responsibility strategy Key milestone and regulatory achievements on R&D transformation Full-year 2021 business EPS guidance revised upward Sanofi Chief Executive Officer, Paul Hudson, commented: The Sanofi business momentum has accelerated in the second quarter, delivering strong financial results driven by our core growth drivers Dupixent and Vaccines. We continue to deliver on our Play to Win strategy, and our second quarter performance gives us confidence in Sanofis growth trajectory for this year. Consequently, we are raising our full-year EPS guidance to around 12%. Significant progress was made across several clinical and regulatory milestones and in June, we formed the Sanofi mRNA vaccines Center of Excellence with the aim to lead the field in this next chapter of vaccine innovation. We are well on our way making Sanofi more representative of communities we serve, executing on our Diversity and Inclusion strategy and creating a work environment where our people can bring their best selves to transform the practice of medicine. Changes in net sales are expressed at constant exchange rates (CER) unless otherwise indicated (definition in Appendix 9)(1) In order to facilitate an understanding of operational performance, Sanofi comments on the business net income statement. Business net income is a non-GAAP financial measure (definition in Appendix 9). The consolidated income statement for Q2 2021 is provided in Appendix 3 and a reconciliation of reported IFRS net income to business net income is set forth in Appendix 4; (2) 2020 restated business EPS was 5.86; (3) Free cash flow is a non-GAAP financial measure (definition in Appendix 9). Source: West Corporation Jul 13, 2021: Banco Santander Sanofi announces Paris 2024 Premium partnership for the Olympic and Paralympic Games in Paris Press releaseSource: Sanofi (EURONEXT: SAN) (NASDAQ: SNY) Sanofi announces Paris 2024 Premium partnership for the Olympic and Paralympic Games in Paris PARIS - 07/13/2021 - Tony Estanguet, Chairman of Paris 2024, Paul Hudson, Sanofi Chief Executive Officer, and Serge Weinberg, Chairman of Sanofis Board of Directors, today announced Sanofi will become a Premium Partner of Paris 2024 for the Olympic and Paralympic Games being held in Paris in 2024. Paris will become the second city to host the summer Olympic Games three times with the last Games held in Paris 100 years ago in 1924. For Sanofi, whose headquarters are based in Paris, this commitment to Paris 2024 is a unique opportunity to engage its 100,000 employees in one of the largest sporting events in the world. Sanofis commitment to Paris 2024 also highlights the companys societal impact strategy and affirms its commitment to the values of inclusion, diversity and openness to the world, as well as its environmental ambition. The company welcomes the desire of Paris 2024 foster the values of the Games to make them even more open to the public and more sustainable and intends to contribute by highlighting the benefits of physical activity on health. Sanofi CEO Paul Hudson added:"Sanofi is proud to contribute to the success of the Olympic and Paralympic Games Paris 2024. It represents a great opportunity to unite our employees around values shared with the Olympics and Paralympics, such as inclusion and diversity, openness to the world, courage, determination and excellence." Source: West Corporation Jun 29, 2021: Banco Santander Sanofi launches dedicated vaccines mRNA Center of Excellence Sanofi launches dedicated vaccines mRNA Center of Excellence Approximately 400million investment annually to accelerate end-to-end R&D of next-generation vaccines, fully financed through resource reallocationFocus on innovating mRNA vaccines beyond pandemic to routine use in diseases with high unmet needExpected minimum of six clinical candidates by 2025 PARIS June 29, 2021 - Sanofi will invest approximately 400 million annually in a first-of-its kind vaccines mRNA Center of Excellence. The Center will work to accelerate the development and delivery of next-generation vaccines by bringing together approximately 400 dedicated employees integrating end-to-end mRNA vaccine capabilities with dedicated R&D, digital, and chemistry, manufacturing and controls (CMC) teams across sites at Cambridge, MA (US) and Marcy lEtoile, Lyon (France).During the COVID-19 pandemic, mRNA technologies demonstrated potential to deliver new vaccines faster than ever before. However, key areas of innovation such as thermostability and tolerability improvements will be critical to unlock the applications of mRNA in routine vaccination against a broader set of infectious diseases and across all ages. The Sanofi mRNA vaccines Center of Excellence aims to lead the field in this next chapter of vaccine innovation, said Jean-Francois Toussaint, Global Head of Research and Development, Sanofi Pasteur. The Center of Excellence will enable acceleration of the vaccines mRNA portfolio developed through the Translate Bio collaboration established in 2018 and expanded in 2020. Source: West Corporation Jun 28, 2021: Banco Santander Nirsevimab shows positive topline results in RSV Phase 2/3 MEDLEY trial Nirsevimab shows positive topline results in RSV Phase 2/3 MEDLEY trial Respiratory syncytial virus (RSV) is the leading cause of hospitalization in all infants1,2Nirsevimab is being investigated as a first-in-class single dose immunization to provide protection for all infants entering their first RSV season MEDLEY is the third pivotal trial to report positive data for nirsevimab; regulatory submissions planned for the first half of 2022 PARIS June 28, 2021 - In positive topline results from the Phase 2/3 MEDLEY trial, nirsevimab showed a similar safety and tolerability profile compared to palivizumab when administered to preterm infants or those with chronic lung disease (CLD) or congenital heart disease (CHD) entering their first respiratory syncytial virus (RSV) season.3 Safety and tolerability were assessed by the occurrence of all treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs). RSV, a seasonal virus that typically circulates in autumn through spring in temperate regions, is the most common cause of lower respiratory tract infections (LRTI) and the leading cause of hospitalizations in all infants.1,2,4These data for nirsevimab are important as they show a safety and tolerability profile comparable to the only available preventative option against lower respiratory tract infections caused by RSV for preterm infants and those with health conditions, said Dr. Joseph Domachowske, Professor of Pediatrics and Professor of Microbiology and Immunology at the State University of New York, Upstate Medical Center and MEDLEY trial primary investigator. Given the typical RSV season lasts nearly five months, there is a potential advantage to providing a preventative option that could help protect all infants with one dose for the entire season.MEDLEY is the third pivotal trial to report positive data for nirsevimab. In April, Sanofi reported that nirsevimab met its primary endpoint of achieving a statistically significant reduction of LRTI caused by RSV in healthy preterm and term infants in the Phase 3 MELODY trial. Coupled with recently published Phase 2b trial results, MELODY and MEDLEY results are part of a robust body of evidence demonstrating the potential of nirsevimab to provide RSV protection to all infants. Results from the MELODY and MEDLEY trials will be presented at forthcoming scientific congresses and, along with the Phase 2b results, will form the basis of global regulatory submissions planned for 2022. Source: West Corporation Jun 28, 2021: Banco Santander Dupixent (dupilumab) SmPC updated with long-term data reinforcing well-established safety profile in adults with moderate-to-severe atopic dermatitis Dupixent (dupilumab) SmPC updated with long-term data reinforcing well-established safety profile in adults with moderate-to-severe atopic dermatitis PARIS and TARRYTOWN, N.Y. June 28, 2021- Long-term safety data from a study of adults with moderate-to-severe atopic dermatitis treated with Dupixent will be added to the Dupixent Summary of Product Characteristics (SmPC) following a positive opinion issued by the European Medicines Agencys Committee for Medicinal Products for Human Use. Data from a single-arm Phase 3 open label extension (OLE) trial showed the long-term safety profile in adults with moderate-to-severe atopic dermatitis treated with Dupixent and observed up to three years was generally consistent with what was observed in the controlled pivotal Phase 3 trials. The OLE trial assessed the long-term safety of Dupixent 300 mg weekly in adults who had previously participated in Dupixent trials or had been screened for a Phase 3 trial. The approved Dupixent dose in adults is 300 mg every other week. Atopic dermatitis is a chronic inflammatory disease of the skin that can be debilitating. Moderate-to-severe atopic dermatitis is characterized by intense persistent itch and skin lesions that can cover much of the body, resulting in skin dryness, cracking, redness or darkening, crusting and oozing. Itch is one of the most burdensome symptoms for patients. Moderate-to-severe atopic dermatitis can also have a substantial emotional and psychosocial impact on patients and their families, causing sleep disturbance, anxiety, depression and feelings of isolation. Source: West Corporation Jun 26, 2021: Banco Santander Sanofi: Availability of the Q2 2021 Memorandum for modelling purposes Sanofi announced today that its Q2 2021 Memorandum for modelling purposes is available on the "Investors" page of the company's website: Source: West Corporation Jun 25, 2021: Banco Santander Sanofi: Libtayo (cemiplimab) approved by the European Commission as the first immunotherapy indicated for patients with advanced basal cell carcinoma Libtayo (cemiplimab) approved by the European Commission as the first immunotherapy indicated for patients with advanced basal cell carcinoma Approval based on data from the largest trial to date in patients with advanced basal cell carcinoma previously treated with a hedgehog pathway inhibitorLibtayo now approved by the European Commission for three advanced cancers PARIS and TARRYTOWN, NY June 25, 2021 The European Commission (EC) has approved Sanofi and Regenerons PD-1 inhibitor Libtayo (cemiplimab) to treat adults with locally advanced or metastatic basal cell carcinoma (BCC) who have progressed on or are intolerant to a hedgehog pathway inhibitor (HHI). BCC is the most common type of skin cancer worldwide, representing up to 80% of non-melanoma skin cancers, and incidence is increasing across many European countries. While the large majority of BCCs are caught early and easily cured with surgery and/or radiation, a small proportion of cases can develop into advanced BCC and penetrate deeper into surrounding tissues (locally advanced) or spread to other parts of the body (metastatic), becoming more difficult to treat. Since its launch in Europe just two years ago, Libtayo has redefined the standard of care for advanced CSCC and has the potential to do the same in advanced BCC, said Peter C. Adamson, M.D., Global Development Head, Oncology at Sanofi. Together with Regeneron, were committed to addressing gaps in the treatment of advanced forms of non-melanoma skin cancer. Source: West Corporation Jun 25, 2021: Banco Santander Sanofi: Libtayo (cemiplimab) approved by the European Commission for first-line treatment of patients with advanced non-small cell lung cancer with 50% PD-L1 expression Libtayo (cemiplimab) approved by the European Commission for first-line treatment of patients with advanced non-small cell lung cancer with 50% PD-L1 expression Approval based on a Phase 3 trial demonstrating Libtayo significantly improved overall survival compared to chemotherapy in advanced NSCLC that included challenging-to-treat patient populationsLibtayo now approved by the European Commission for three advanced cancers PARIS and TARRYTOWN, NY June 25, 2021 - The European Commission (EC) has approved Sanofi and Regenerons PD-1 inhibitor Libtayo (cemiplimab) for the first-line treatment of adults with non-small cell lung cancer (NSCLC) whose tumor cells have 50% PD-L1 expression and no EGFR, ALK or ROS1 aberrations. Patients must have metastatic NSCLC or locally advanced NSCLC and not be a candidate for definitive chemoradiation. Libtayo is now approved for three advanced cancers in the European Union. The EC also approved Libtayo in advanced basal cell carcinoma, the first treatment to be indicated for those patients who have progressed on or are intolerant to a hedgehog pathway inhibitor (HHI). In 2019, Libtayo was approved by the EC as the first treatment for adults with metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC) who are not candidates for curative surgery or curative radiation. Across all of its approved indications, Libtayo had a generally consistent safety profile. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue during or after treatment with Libtayo.We are confident that Libtayo has the potential to become an important treatment option for patients in the European Union and thank all the investigators, patients and their families who helped us reach this milestone, said Peter C. Adamson, M.D., Global Development Head, Oncology at Sanofi. We are anticipating results from our ongoing Phase 3 trial of Libtayo plus chemotherapy in patients with advanced non-small cell lung cancer and remain committed to studying Libtayo in additional cancer settings where there is the potential to improve the outcome for patients. Source: West Corporation Jun 18, 2021: Banco Santander European Commission approves Aubagio (teriflunomide) as the first oral MS therapy for first-line treatment of children and adolescents living with relapsing-remitting multiple sclerosis European Commission approves Aubagio (teriflunomide) as the first oral MS therapy for first-line treatment of children and adolescents living with relapsing-remitting multiple sclerosis PARIS June 18, 2021 - The European Commission (EC) has approved Aubagio (teriflunomide) for the treatment of pediatric patients 10 to 17 years of age with relapsing-remitting multiple sclerosis (RRMS). The EC approval is based on data from the Phase 3 TERIKIDS study. The approval confirms Aubagio as the first oral multiple sclerosis (MS) therapy for first-line treatment of children and adolescents with MS in the European Union. MS affects an estimated 2.8 million people around the world, with children and adolescents representing at least 30,000 of those impacted.1,2 Pediatric MS is a rare condition and onset follows a relapsing-remitting disease course in 98 percent of pediatric patients.3,4 Compared with adult-onset MS, pediatric patients often present with higher relapse rates and a greater lesion burden.5 Due to the earlier onset of disease, irreversible disability and secondary progression often occur at an earlier age than with adult counterparts.3 The symptoms of MS can impact all aspects of a young persons life from physical health to social development and self-esteem.6Pediatric multiple sclerosis remains an area of significant unmet medical need, said Erik Wallstrom, MD, PhD, Therapeutic Area Head, Neurology Development at Sanofi Genzyme. The European approval of Aubagio in pediatrics means young people with MS have a new treatment option, and importantly - one that can offer meaningful improvement in managing this serious disease. Aubagio was initially approved in the EU in 2013 for the treatment of adult patients with RRMS and the EC approval for the pediatric indication provides an additional year of marketing protection in the European Union. Source: West Corporation Jun 08, 2021: Banco Santander Sanofi launches its new global employee share ownership plan PARIS - June 7, 2021 - Sanofi today launches Action 2021, its global employee share ownership plan, open to 92,000 employees in 73 countries. The program, similar to programs carried out since 2013, clearly demonstrates the ongoing commitment of Sanofi and its Board of Directors to involve all employees, across all its territories, in the future development and results of the company. Source: West Corporation Jun 07, 2021: Banco Santander Sanofi launches its new global employee share ownership plan PARIS - June 7, 2021 - Sanofi today launches Action 2021, its global employee share ownership plan, open to 92,000 employees in 73 countries. The program, similar to programs carried out since 2013, clearly demonstrates the ongoing commitment of Sanofi and its Board of Directors to involve all employees, across all its territories, in the future development and results of the company. Source: West Corporation Jun 04, 2021: Banco Santander Sanofi partnering with leading academic cooperative groups to study amcenestrant in the adjuvant setting for patients with estrogen receptor positive breast cancer Sanofi partnering with leading academic cooperative groups to study amcenestrant in the adjuvant setting for patients with estrogen receptor positive breast cancer Sanofi partnering with the Breast International Group (BIG), the European Organization for Research and Treatment of Cancer (EORTC) and Alliance Foundation Trials (AFT), which are world-leading academic groups delivering practice-changing breast cancer clinical researchCollaborating on the Phase 3 AMEERA-6 study expected to be the first pivotal trial of an oral selective estrogen receptor degrader (SERD) in the adjuvant setting and will evaluate the safety and efficacy of Sanofis investigational amcenestrant in estrogen receptor-positive (ER+) patients who prematurely discontinue standard therapy and have high risk of disease recurrenceParties to finalize full terms of this cooperative effortAdditional treatment options in early breast cancer are needed to help prevent patients from developing advanced, incurable disease and would represent a significant treatment advance PARIS June 4, 2021 Sanofi is partnering with leading groups delivering practice-changing breast cancer research, the Breast International Group (BIG), the European Organization for Research and Treatment of Cancer (EORTC) and the Alliance Foundation Trials (AFT), to initiate a pivotal trial of an oral selective estrogen receptor degrader (SERD) in the adjuvant setting. The Phase 3 AMEERA-6 study will evaluate the efficacy and safety of Sanofis amcenestrant vs tamoxifen for women with estrogen receptor-positive (ER+) breast cancer who were unable to continue their adjuvant aromatase inhibitor (AI) therapy. Together with our research partners, BIG conducts landmark, practice-changing trials that can have a significant impact on the lives of women with breast cancer, said David Cameron, Chair of the BIG Executive Board.Adjuvant therapy helps prevent and delay the progression of disease into the later setting. However, current adjuvant therapies, like AIs, can have side effects for some women, which may cause them to discontinue the medication prematurely. Amcenestrant may be a potential option for women in this setting and we look forward to working with Sanofi, EORTC and AFT to investigate this further. Source: West Corporation Jun 03, 2021: Banco Santander Sanofi launches 3 million Planet Mobilization fund to support employees environmental projects Sanofi launches 3 million Planet Mobilization fund to support employees environmental projects This year, Sanofi will fund three employee teams for their environmental programs in Vietnam, Ireland, France, Belgium and ItalyIn April 2021, Sanofi expanded its social commitments, including its global environmental sustainability program, Planet Mobilization PARIS June 3, 2021 As part of a long-standing commitment to reduce the environmental footprint of the companys products and activities, Sanofi launched a 3 million Planet Mobilization fund to support employee ideas and projects that will further contribute to a healthier environment. This year, three Sanofi teams will have their projects funded. For several years, Sanofi has been implementing a global environmental roadmap, Planet Mobilization, which is embedded in Sanofis long-term strategy. The program covers all Sanofi activities and sites and the entire lifecycle of products, from raw materials used in production all the way to their disposal. Because the fight against climate change is also a fight for the health and well-being, Sanofi commits to Planet Mobilization says Philippe Luscan, Executive Vice President, Global Industrial Affairs. We strongly believe our employees are the most powerful agents of positive change for people, and for the planet. Its with this ambition and objectives in mind that we decided to create a fund of 3 million to finance ideas and projects coming from our employees in support of our environmental ambition. Today, it is fair to say that teams all over the world took up the challenge, even beyond our expectations. Thats collective intelligence in motion. Source: West Corporation Jun 01, 2021: Banco Santander Sanofi provides update on venglustat clinical program Sanofi provides update on venglustat clinical program PARIS JUNE 1, 2021 A pivotal Phase 2/3 study of venglustat in autosomal dominant polycystic kidney disease (ADPKD) did not meet futility criteria, and the company has halted the clinical program in ADPKD. The safety profile of venglustat remains consistent with previously reported results with more than 500 patients treated to date over a period of up to four years across all clinical programs. Biomarker data from the study confirmed venglustat effectively inhibits the glycosphingolipid (GSL) pathway by demonstrating a reduction in GL-1, a lipid that accumulates in certain cells. The STAGED-PKD study was stopped for futility following an independent analysis of the annualized rate of change in total kidney volume (TKV) in patients receiving venglustat compared to placebo. Trends from the analysis showed venglustat did not provide a meaningful reduction in TKV growth rate, the primary endpoint of stage 1 of the Phase 2/3 study. This interim analysis suggests the reduction of GSLs may not play a significant role in the prevention of kidney cyst growth, and as such, may not be a primary pathway associated with the progression of ADPKD. The investigational research of venglustat in ADPKD was an attempt to explore a novel biological role for GSLs beyond the established role of these lipids in lysosomal storage diseases (LSDs). The venglustat development program started with our confidence in the promise of a potential breakthrough treatment to address the unmet needs of people living with lysosomal storage disorders, said John Reed, M.D., Ph.D., Global Head of Research and Development at Sanofi. In parallel, we set out to evaluate venglustat in autosomal dominant polycystic kidney disease, a leading cause of kidney transplant. This outcome is not what we hoped for, especially for these patients. However, our research has furthered the scientific understanding of ADPKD by demonstrating that modulating the GSL pathway is insufficient to restore kidney function in adults affected by this disease. Source: West Corporation May 27, 2021: Banco Santander Sanofi and GSK initiate global Phase 3 clinical efficacy study of COVID-19 vaccine candidate Sanofi and GSK initiate global Phase 3 clinical efficacy study of COVID-19 vaccine candidate Two-stage design will evaluate vaccine formulations targeting original D.614 virus as well as B.1.351 variant, in diverse geographies with multiple circulating variants A booster study program will begin in the coming weeks to complement Phase 3 trialPending positive Phase 3 outcomes and regulatory reviews, the vaccine could be approved in Q4 2021 PARIS and LONDON May 27, 2021 Today, Sanofi and GSK started enrollment in their Phase 3 clinical study to assess the safety, efficacy, and immunogenicity oftheir adjuvanted recombinant-protein COVID-19 vaccine candidate. The global, randomized, double-blind placebo-controlled Phase 3 study will include more than 35,000 volunteersaged 18 and olderfrom several countries, including sites in the US, Asia, Africa, and Latin America. The primary endpoint of the study is the prevention of symptomatic COVID-19 in SARS-CoV-2 naive adults, with secondary endpoints being the prevention of severe COVID-19 disease and prevention of asymptomatic infection. In a two-stage approach, the study will initially investigate the efficacy of a vaccine formulation targeting the original D.614 virus (Wuhan), while a second stage will evaluate a second formulation targeting the B.1.351 (South African) variant. Recent scientific evidence1 shows that antibodies created against the B.1.351 variant may provide broad cross-protection against other more transmissible variants. The design of the Phase 3, conducted across a broad diversity of geographies, also allows evaluation of the efficacy of the candidate against a variety of circulating variants. Source: West Corporation May 19, 2021: Banco Santander Early amcenestrant data featured at ASCO support its potential to become a new endocrine backbone therapy for ER+/HER2- breast cancer Early amcenestrant data featured at ASCO support its potential to become a new endocrine backbone therapy for ER+/HER2- breast cancer Amcenestrant, an investigational oral selective estrogen receptor degrader (SERD), achieved an objective response rate of 34% and a clinical benefit rate of 74% in Phase 1 study (AMEERA-1) in combination with palbociclibOverall safety profile of amcenestrant with palbociclib is consistent with what was observed in monotherapy, without signs of significant cardiac or ocular side effects The Phase 3 combination study (AMEERA-5) of amcenestrant with palbociclib in the first-line setting was initiated in October 2020 and is successfully recruiting patients The pivotal study (AMEERA-3) of amcenestrant versus physicians choice in locally advanced or metastatic estrogen receptor-positive (ER+) breast cancer is fully recruited; readout expected in H2 2021 PARIS May 19, 2021 Phase 1 data from the AMEERA-1 study evaluating amcenestrant, an investigational oral selective estrogen receptor degrader (SERD), will be presented at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting. In a pooled analysis, amcenestrant in combination with palbociclib showed encouraging antitumor activity in postmenopausal women with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer (MBC). These early clinical data show that the combination of amcenestrant with palbociclib achieved encouraging antitumor activity, said Sarat Chandarlapaty, M.D., Ph.D., Medical Oncologist, Memorial Sloan Kettering Cancer Center. The analysis also demonstrated no clinically significant cardiac or ocular findings and an overall safety profile in line with what we saw in the monotherapy setting. Its notable to see this kind of activity in patients with ER+ metastatic breast cancer, where there is a clear need for new therapeutic options. Source: West Corporation May 17, 2021: Banco Santander Sanofi and GSK COVID-19 vaccine candidate demonstrates strong immune responses across all adult age groups in Phase 2 trial Sanofi and GSK COVID-19 vaccine candidate demonstrates strong immune responses across all adult age groups in Phase 2 trial Adjuvanted recombinant COVID-19 vaccine candidate triggered strong neutralizing antibody responses in all adult age groupsHigh immune response after a single dose in patients with prior infection shows strong booster potentialGlobal Phase 3 study expected to start in the coming weeks PARIS and LONDON May 17, 2021 The Sanofi and GSK adjuvanted recombinant COVID-19 vaccine candidate achieved strong rates of neutralizing antibody responses, in line with those measured in people who have recovered from COVID-19, in all adult age groups in a Phase 2 study with 722 volunteers. A global pivotal Phase 3 study is expected to start in the coming weeks. The Phase 2 interim results showed 95% to 100% seroconversion following a second injection in all age groups (18 to 95 years old) and across all doses, with acceptable tolerability and with no safety concerns. Overall, the vaccine candidate elicited strong neutralizing antibody levels that were comparable to those generated by natural infection, with higher levels observed in younger adults (18 to 59 years old). After a single injection, high neutralizing antibody levels were generated in participants with evidence of prior SARS-CoV-2 infection, suggesting strong potential for development as a booster vaccine. Our Phase 2 data confirm the potential of this vaccine to play a role in addressing this ongoing global public health crisis, as we know multiple vaccines will be needed, especially as variants continue to emerge and the need for effective and booster vaccines, which can be stored at normal temperatures, increases, said Thomas Triomphe, Executive Vice President and Global Head of Sanofi Pasteur. With these favorable results, we are set to progress to a global Phase 3 efficacy study. We look forward to generating additional data and working with our partners around the world to make our vaccine available as quickly as possible. Source: West Corporation May 17, 2021: Banco Santander Pivotal data at ATS 2021 show Dupixent (dupilumab) significantly reduced asthma attacks and improved lung function in children Pivotal data at ATS 2021 show Dupixent (dupilumab) significantly reduced asthma attacks and improved lung function in children Dupixent is the only biologic medicine to improve lung function in children aged 6 to 11 years with uncontrolled moderate-to-severe asthma in a randomized Phase 3 trial, with potential to be best-in-class treatment for these patientsResults further support well-established safety profile of DupixentFDA decision for children with moderate-to-severe asthma expected by October 21, 2021 PARIS and TARRYTOWN, N.Y. May 17, 2021 Detailed results from a Phase 3 trial showed Dupixent (dupilumab) significantly reduced severe asthma attacks, and within two weeks rapidly improved lung function in children aged 6 to 11 years with uncontrolled moderate-to-severe asthma, with evidence of type 2 inflammation. Dupixent also significantly improved overall asthma symptom control and reduced an airway biomarker of type 2 inflammation that plays a major role in asthma, called fractional exhaled nitric oxide (FeNO). These data are being presented at the 2021 American Thoracic Society International Conference (ATS 2021) and featured in the Breaking News: Clinical Trial Results in Pulmonary Medicine Scientific Symposium.Children living with uncontrolled moderate-to-severe asthma experience serious and persistent symptoms that can impact many crucial aspects of their lives including school, sleep and exercise, says Leonard B. Bacharier, M.D., Professor of Pediatrics and Director of the Center for Pediatric Asthma Research, Monroe Carell Jr. Children's Hospital at Vanderbilt University Medical Center in Nashville, Tennessee and principal investigator of the trial. The trial results show that dupilumab, when added to standard of care therapy, significantly reduced asthma attacks, rapidly improved lung function and improved asthma control, which is especially important to these children during a particularly formative time in their lives.Asthma is the most common chronic disease in children, with approximately 75,000 children aged 6 to 11 years living with the uncontrolled moderate-to-severe form of the disease in the U.S., and many more worldwide. Despite treatment with current standard-of-care inhaled corticosteroids and bronchodilators, these children may continue to experience serious symptoms such as coughing, wheezing and difficulty breathing. They also may require the use of multiple courses of systemic corticosteroids that carry significant risks. Children who have asthma with underlying type 2 inflammation, which is the most common cause of asthma in children, are more likely to have poor asthma control, more frequent asthma attacks and symptoms that interfere with day-to-day activities. The Phase 3, randomized, double-blind, placebo-controlled VOYAGE trial evaluated the efficacy and safety of Dupixent (100 mg or 200 mg every two weeks, based on weight) combined with standard-of-care asthma therapy in 408 children with uncontrolled moderate-to-severe asthma. Two pre-specified populations with evidence of type 2 inflammation were evaluated for the primary analysis: 1) patients with baseline blood eosinophils (EOS) 300 cells/l (n=259) and 2) patients with FeNO 20 parts per billion (ppb) or EOS 150 cells/l; n=350. Source: West Corporation May 06, 2021: Banco Santander Sanofi establishes three-year collaboration with Stanford Medicine to accelerate immunology research Projects led by collaborating researchers from the two organizations will focus on autoimmune diseases and inflammatory conditions Source: West Corporation Apr 28, 2021: Banco Santander Sanofi continued its growth trajectory. Strong increase in Q1 2021 business EPS(1) at CER General Medicines core assets grew 4.4%, while GBU sales were down 3.8% Source: West Corporation Apr 26, 2021: Banco Santander Nirsevimab demonstrated protection against respiratory syncytial virus disease in healthy infants in Phase 3 trial Nirsevimab met its Phase 3 primary endpoint earlier than anticipated; regulatory submissions for all-infant indication to begin in 2022. Source: West Corporation Apr 24, 2021: Banco Santander New Dupixent (dupilumab) analyses reinforce long-term safety and efficacy profile in patients with atopic dermatitis as young as 6 years PARIS - April 23, 2021 - New analyses from Dupixent (dupilumab) trials evaluated infection incidence reduction and reinforced the need for no laboratory monitoring in patients six years and older with moderate-to-severe atopic dermatitis. Additional analyses evaluated response rates across a broad population, and the impact of Dupixent on disease extent and severity, quality of life (QoL), and itch. These and other data from real-world settings and clinical trials, including the Dupixent open-label extension (OLE) trials, will be presented at the American Academy of Dermatology (AAD VMX 2021), April 23-25, and at the 20th European Society for Pediatric Dermatology Annual Meeting (ESPD 2021), May 12-14. Source: West Corporation Apr 07, 2021: Banco Santander Sanofi expands its social commitments, creates nonprofit unit to provide poorest countries with access to essential medicines In an open letter, Sanofi Chief Executive Officer Paul Hudson today outlined several key projects that the company will implement to increase the impact of its Corporate Social Responsibility (CSR) strategy. Embedded in Sanofi's long-term strategy, the companyaEUR(TradeMark)s commitment is based on four essential pillars in which Sanofi is uniquely positioned to make a difference: access to medicines, support for vulnerable communities, preservation of the environment, and inclusion and diversity of its employees. Source: West Corporation Mar 12, 2021: Banco Santander Sanofi and Translate Bio initiate Phase 1/2 clinical trial of mRNA COVID19 vaccine candidate Expected to enroll 415 participants; interim results expected in Q3 2021 Source: West Corporation Feb 12, 2021: Banco Santander The Lancet publishes Libtayo(Registered) (cemiplimab) data showing extended overall survival in patients with first-line advanced non-small cell lung cancer with PD-L1 expression of 50% PARIS and TARRYTOWN, N.Y. aEUR February 12, 2021 aEUR The Lancet today published results from a pivotal trial designed to evaluate the investigational use of the PD-1 inhibitor LibtayoA(Registered) (cemiplimab) compared to platinum-doublet chemotherapy in patients with locally advanced or Source: West Corporation Feb 10, 2021: Banco Santander FDA approves Libtayo (Cemiplimab-rwlc) as first immunotherapy indicated for patients with advanced basal cell carcinoma The U.S. Food and Drug Administration (FDA) has approved the PD-1 inhibitor LibtayoA(Registered) (cemiplimab-rwlc) as the first immunotherapy indicated for patients with advanced basal cell carcinoma (BCC) previously treated with a hedgehog pathway inhibitor (HHI) or for whom an HHI is not appropriate. Full approval was granted for patients with locally advanced BCC and accelerated approval was granted for patients with metastatic BCC. Source: West Corporation Feb 05, 2021: Banco Santander Capital Markets Day 2021: Sanofi progresses on its strategy to drive growth across its businesses and innovation with emerging leadership in immunology Execution of strategic plan announced in December 2019 is well underway with key growth drivers delivering New business focus in General Medicines and Consumer Healthcare designed to accelerate SanofiaEUR(TradeMark)s growth, cash flow generation, and improve profitability Source: West Corporation 2020 Dec 18, 2020: Banco Santander Availability of the Q4 2020 Memorandum for modelling purposes Paris, France - December 17, 2020 - Sanofi announced today that its Q4 2020 Memorandum for modelling purposes is available on the "Investors" page of the company's website: https://www.sanofi.com/en/investors/financial-results-and-events/financial-results/Q4-results-2020 Source: West Corporation Dec 15, 2020: Banco Santander Sanofi renews partnership with the WHO to fight Neglected Tropical Diseases and eliminate sleeping sickness before 2030 Sanofi has signed on December 10th a renewed partnership agreement with the World Health Organization (WHO), consolidating a 20-year collaboration to fight some of the most Neglected Tropical Diseases (NTDs) and supporting the WHO in its commitment to sustainably eliminate sleeping sickness before 2030. Source: West Corporation Dec 11, 2020: Banco Santander CHMP recommends approval of Plavix (clopidogrel) with aspirin in adults for certain types of strokes The European Medicines AgencyaEUR(TradeMark)s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for an additional indication for PlavixA(Registered) (clopidogrel) in adult patients with high-risk transient ischemic attack (TIA) or minor ischemic stroke (IS). This new indication includes Plavix used alongside aspirin within 24 hours of an event and continued for 21 days, followed by long-term single anti-platelet therapy. Source: West Corporation Dec 10, 2020: Banco Santander Sanofi and GSK announce a delay in their adjuvanted recombinant protein-based COVID-19 vaccine program to improve immune response in the elderly Phase 1/2 interim results showed an immune response comparable to patients who recovered from COVID-19 in adults aged 18 to 49 years Insufficient response in older adults demonstrates the need to refine the concentration of antigen in order to provide high-level immune response across all age groups Companies plan a Phase 2b study with an improved antigen formulation With support from BARDA as part of Operation Warp Speed, study to start in February 2021, including a proposed comparison with an authorized COVID-19 vaccine Product availability now expected in Q4 2021 pending successful completion of the development plan Source: West Corporation Nov 30, 2020: Banco Santander Dupixent(Registered) (dupilumab) approved by European Commission as first and only biologic medicine for children aged 6 to 11 years with severe atopic dermatitis Pivotal trial showed more than four times as many children achieved itch reduction and more than three times as many children achieved clear or almost clear skin with Dupixent plus topical corticosteroids (TCS) compared to TCS alone Source: West Corporation Nov 19, 2020: Banco Santander European Commission approves Supemtek(Registered) (quadrivalent recombinant influenza vaccine) for the prevention of influenza in adults aged 18 years and older The European Commission has granted a marketing authorization for SupemtekA(Registered), a quadrivalent (four-strain) recombinant influenza vaccine, for the prevention of influenza in adults aged 18 years and older. Supemtek is the first and only recombinant influenza vaccine now approved in the European Union. Source: West Corporation Nov 19, 2020: Banco Santander Rilzabrutinib granted FDA Fast Track Designation for treatment of immune thrombocytopenia PARIS - November 18, 2020 aEUR" The U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to the oral investigational Bruton's tyrosine kinase (BTK) inhibitor, rilzabrutinib, which has the potential to be the first BTK inhibitor for the treatment of immune thrombocytopenia (ITP). In addition, following positive Phase 1/2 study results, a Phase 3 study evaluating rilzabrutinib for ITP has been initiated. Rilzabrutinib received orphan drug designation from the FDA for the treatment of ITP in October 2018. Source: West Corporation Nov 19, 2020: Banco Santander FDA grants priority review for avalglucosidase alfa, a potential new therapy for Pompe disease PARIS - November 18, 2020 - The U.S. Food and Drug Administration (FDA) has accepted for priority review the Biologics License Application (BLA) for avalglucosidase alfa for long-term enzyme replacement therapy for the treatment of patients with Pompe disease (acid I-glucosidase deficiency). The target action date for the FDA decision is May 18, 2021. Source: West Corporation Oct 28, 2020: Banco Santander Sanofi and GSK to support COVAX with 200 million doses of adjuvanted, recombinant protein-based COVID-19 vaccine Sanofi and GSK have signed a Statement of Intent with Gavi, the legal administrator of the COVAX Facility, a global risk-sharing mechanism for pooled procurement and equitable distribution of eventual COVID-19 vaccines. Sanofi and GSK intend to make available 200 million doses of their adjuvanted recombinant protein-based COVID-19 vaccine, if approved by regulatory authorities and subject to contract, to the COVAX Facility. Both Companies intend to contribute to COVAX's ambition to ensure successful COVID-19 vaccines reach those in need, whoever they are and wherever they live, once they obtain appropriate approvals. Source: West Corporation Oct 26, 2020: Banco Santander Dupixent(Registered) (dupilumab) late-breaking pivotal data showing significant improvement in eosinophilic esophagitis signs and symptoms presented for the first time at scientific meetings Additional positive results were announced from Part A of a pivotal Phase 3 trial evaluating the investigational use of DupixentA(Registered) (dupilumab) in patients 12 years and older with eosinophilic esophagitis (EoE). As previously reported, the trial met both of its co-primary and all key secondary endpoints. New late-breaking data showing additional improvements in disease severity and extent at the microscopic level, as well as normalization of gene expression pattern associated with type 2 inflammation, were presented at the virtual American College of Gastroenterology (ACG) Annual Scientific Meeting and the United European Gastroenterology (UEG) Week Virtual 2020. Source: West Corporation Oct 16, 2020: Banco Santander CHMP recommends approval of Dupixent (dupilumab) for children aged 6 to 11 years with severe atopic dermatitis The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for DupixentA(Registered) (dupilumab), recommending to extend the approval in the European Union (EU) to include children aged 6 to 11 years with severe atopic dermatitis who are candidates for systemic therapy. Source: West Corporation Oct 15, 2020: Banco Santander Sanofi and Translate Bio mRNA COVID-19 vaccine candidate induced high antibody levels in preclinical studies Sanofi Pasteur, the vaccines global business unit of Sanofi, and Translate Bio (NASDAQ: TBIO), a clinical-stage messenger RNA (mRNA) therapeutics company, today announced the preclinical results for MRT5500, a mRNA-based vaccine candidate against SARS-CoV-2, the virus that causes COVID-19 disease. Source: West Corporation Oct 02, 2020: Banco Santander EMA accepts regulatory submission for avalglucosidase alfa, a potentially new standard of care enzyme replacement therapy for Pompe disease The European Medicines Agency (EMA) has accepted for review the Marketing Authorization Application (MAA) for avalglucosidase alfa, for long-term enzyme replacement therapy for the treatment of patients with Pompe disease. Avalglucosidase alfa is an investigational enzyme replacement therapy, which, if approved, would offer a potential new standard of care for patients with Pompe disease. Source: West Corporation Sep 23, 2020: Banco Santander Sanofi and GSK sign agreements with the Government of Canada to supply up to 72 million doses of adjuvanted COVID-19 vaccine PARIS and LONDON aEUR" September 22, 2020 aEUR" Sanofi and GSK have today signed agreements with the Government of Canada for the supply of up to 72 million doses of an adjuvanted COVID-19 vaccine, beginning in 2021. aEURoeTodayaEUR(TradeMark)s announcement showcases our unwavering commitment to develop a COVID-19 vaccine that is available to everyone when it comes to market,aEUR said Thomas Triomphe, Executive Vice President and Global Head of Sanofi Pasteur. aEURoeTo address a global health crisis of this magnitude, it takes partnerships and we are grateful to Canada for its collaboration, and to GSK for partnering with us to develop a safe and effective vaccine.aEUR Source: West Corporation Sep 18, 2020: Banco Santander Dr. Jean-Christophe Rufin appointed President of the Sanofi Espoir Corporate Foundation Dr. Jean-Christophe Rufin appointed President of the Sanofi Espoir Corporate Foundation PARIS - September 18, 2020 - Sanofi today announced the appointment of Dr. Jean-Christophe Rufin as President of the Sanofi Espoir Corporate Foundation. Jean-Christophe Rufin succeeds Xavier Darcos, who presided over the Foundation since 2015. "We are delighted that Dr. Jean-Christophe Rufin has accepted to serve as President of the Sanofi Espoir Foundation", said Serge Weinberg, President of Sanofi. "His experience as both a physician and diplomat gives him a broad expertise in humanitarian and public health issues around the world. He will enable us to step up our response to health distress among vulnerable populations. Through his literary work, he has amply demonstrated his humanist commitments and his capacity to understand international realities." The Sanofi Espoir Foundation's mission is to help reduce health inequalities among the world's most vulnerable populations. At the end of 2019, the Foundation was coordinating 77 projects in 50 countries in four main areas of focus: The fight against pediatric cancers in countries with limited resourcesCombating maternal and neonatal mortality in low- and middle-income countriesAccess to healthcare for people in vulnerable situations in FranceSupport for families in the event of health crises "It is a great honor for me to preside over the Sanofi Espoir Foundation," said Dr. Jean-Christophe Rufin. "I salute the work accomplished over the past 10 years to reduce health inequalities, and I am committed to taking this even further, by broadening the Sanofi Espoir Foundation's areas of involvement and methods for action." Source: West Corporation Sep 18, 2020: Banco Santander Positive pivotal data for Libtayo (cemiplimab) monotherapy in locally advanced basal cell carcinoma featured as a late-breaking presentation at ESMO Positive pivotal data for Libtayo (cemiplimab) monotherapy in locally advanced basal cell carcinoma featured as a late-breaking presentation at ESMO Libtayo is the first investigational medicine to show a clinical benefit in advanced basal cell carcinoma following treatment with a hedgehog inhibitor in a prospective trial31% objective response rate seen in trial patients, and an estimated 85% of responses were ongoing at one year PARIS and TARRYTOWN, N.Y. - September 18, 2020 - Positive results from the pivotal Phase 2 trial for the PD-1 inhibitor Libtayo (cemiplimab) in patients with locally advanced basal cell carcinoma (BCC) who had progressed on or were intolerant to hedgehog inhibitor (HHI) therapy were shared in a late-breaking presentation at the European Society for Medical Oncology (ESMO) Virtual Congress 2020. The data will form the basis of regulatory submissions, including in the U.S. and European Union. "Advanced basal cell carcinoma can be an unrelenting, highly disfiguring disease, and there are no approved treatment options once a patient progresses on or becomes intolerant to hedgehog inhibitors," said Alexander Stratigos, M.D., Professor of Dermatology at the University of Athens Medical School at Andreas Sygros Hospital and a trial investigator. "This is the first time a prospective trial of an investigational medicine has shown a clinical benefit in this patient population, and the Libtayo data provide hope for this difficult-to-treat cancer." Per independent central review, the objective response rate (ORR) was 31% among Libtayo-treated patients (n=84; 95% confidence interval [CI]: 21-42%), with a median follow-up of 15 months (range: 1-25 months). This included a 6% (n=5) complete and 25% (n=21) partial response rate. This is an increase from the ORR shared in May and includes two responses that were confirmed after the initial data analysis. Responses were seen regardless of baseline PD-L1 expression in tumor cells. Source: West Corporation Sep 14, 2020: Banco Santander FDA grants Dupixent (dupilumab) Breakthrough Therapy designation for eosinophilic esophagitis FDA grants Dupixent (dupilumab) Breakthrough Therapy designation for eosinophilic esophagitis Designation based on positive results from Part A of pivotal Phase 3 trial Dupixent is the first and only biologic to show positive and clinically-meaningful Phase 3 results in patients 12 years and older with eosinophilic esophagitis (EoE)There are currently no FDA-approved treatments for this chronic type 2 inflammatory disease that damages the esophagus and impacts patients' ability to swallow and eatDesignation supports Dupixent's potential in another disease driven by type 2 inflammation PARIS and TARRYTOWN, N.Y., September 14, 2020 - The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to Dupixent (dupilumab) for the treatment of patients 12 years and older with eosinophilic esophagitis (EoE). The designation for this investigational use is based on positive results from Part A of a Phase 3 trial in patients with EoE. There are currently no FDA-approved medicines for EoE, a chronic and progressive type 2 inflammatory disease that damages the esophagus and prevents it from working properly. Over time, excessive type 2 inflammation causes scarring and narrowing of the esophagus, making it difficult to swallow. If left untreated, EoE can affect a patient's ability to eat and cause food to become stuck after being swallowed (food impaction), which can lead to a medical emergency. Source: West Corporation Sep 10, 2020: Banco Santander New England Journal of Medicine publishes positive final results from Phase 1/2a study of BIVV001 in people with severe hemophilia A The New England Journal of Medicine today published positive final results from the Phase 1/2a trial evaluating the safety, tolerability and pharmacokinetics of BIVV001 (rFVIIIFc-VWF-XTEN) in adult patients with severe hemophilia A. BIVV001 is an investigational factor VIII therapy designed to provide higher bleed protection in a once-weekly prophylactic treatment regimen. Sanofi and Sobia"cents (STO:SOBI) collaborate on the development and commercialization of BIVV001. Source: West Corporation Sep 08, 2020: Banco Santander Dupixent (dupilumab) long-term data show sustained improvement in lung function and reduction in severe exacerbations in adults and adolescents with moderate-to-severe asthma With more than 2,200 patients enrolled, Phase 3 open-label extension trial is the largest of a biologic medicine ever conducted in asthmaData up to three years show a safety profile consistent with pivotal asthma trialsDupixent is the only biologic to demonstrate sustained improvements in lung function and asthma exacerbations across a broad patient population with type 2 inflammationData to be presented at the 2020 ERS International Congress PARIS and TARRYTOWN, NY - September 8, 2020 - New results from a Dupixent (dupilumab) Phase 3 open-label extension trial showed that the safety and efficacy profile observed in previous Dupixent trials were maintained for up to three years in adults and adolescents with moderate-to-severe asthma. Data from the trial will be presented during a live session at the virtual 2020 European Respiratory Society (ERS) International Congress. "These data suggest Dupixent may slow the progressive decline in lung function that many patients with moderate-to-severe asthma experience, as shown by the sustained improvement in lung function for up to three years. Further, patients on Dupixent maintained asthma control and reduced rates of severe asthma attacks that may result in hospitalizations," said Michael Wechsler, M.D., M.M.Sc., Director of the National Jewish Cohen Family Asthma Institute in Denver, Colorado, and principal investigator of the trial. "This reinforces the importance of Dupixent as a continuous, long-term treatment option to improve patients' ability to breathe and maintain control of their asthma, particularly in those with higher markers of underlying type 2 inflammation." The analyses to be presented at ERS include more than 2,200 patients who previously participated in Dupixent asthma trials, including three pivotal trials that lasted between 24 and 52 weeks. Patients entered the extension trial after finishing active treatment or placebo in the initial trials and were treated for up to an additional two years, providing up to three years of treatment data in total. The safety analyses included patients from all three pivotal asthma trials and the efficacy and biomarker analyses included patients who are not dependent on oral corticosteroids (OCS) from the pivotal Phase 2b and Phase 3 QUEST trials. Additional long-term efficacy data in OCS-dependent patients will be presented at a later congress. Results showed: Source: West Corporation Sep 03, 2020: Banco Santander Sanofi and GSK initiate Phase 1/2 clinical trial of COVID-19 adjuvanted recombinant protein-based vaccine candidate Sanofi and GSK initiate Phase 1/2 clinical trial of COVID-19 adjuvanted recombinant protein-based vaccine candidate Pre-clinical studies show promising safety and immunogenicity.Over 400 participants being enrolled in Phase 1/2 study Pending positive Phase 1/2 data, companies aim to move into Phase 3 by end of 2020Sanofi and GSK are scaling up manufacturing of the antigen and adjuvant with the target of producing up to one billion doses in 2021 PARIS and LONDON - Sept. 3, 2020 - Sanofi and GSK today started the Phase 1/2 clinical trial for their adjuvanted COVID-19 vaccine. The vaccine candidate, developed in partnership by Sanofi and GSK, uses the same recombinant protein-based technology as one of Sanofi's seasonal influenza vaccines with GSK's established pandemic adjuvant technology. The Phase 1/2 clinical trial is a randomized, double blind and placebo-controlled trial designed to evaluate the safety, reactogenicity (tolerability) and immunogenicity (immune response) of the COVID-19 vaccine candidate. A total of 440 healthy adults are being enrolled in the trial across 11 investigational sites in the United States. The companies anticipate first results early December 2020 which will support the initiation of a Phase 3 trial in December 2020. If data are sufficient for licensure application, the plan is to request regulatory approval in the first half of 2021. Sanofi is leading the clinical development and registration of the COVID-19 vaccine. Preclinical data showed an acceptable reactogenicity profile and data based on two injections of the adjuvanted recombinant vaccine showed high levels of neutralizing antibodies that are comparable to levels in humans who recovered from the COVID-19 infection. Pre-clinical results will be published later this year. In parallel, Sanofi and GSK are scaling up manufacturing of the antigen and adjuvant with the target of producing up to one billion doses in 2021. Source: West Corporation Sep 01, 2020: Banco Santander Sanofi provides update on Kevzara (sarilumab) Phase 3 trial in severe and critically ill COVID-19 patients outside the U.S. PARIS - September 1, 2020 - Sanofi today announced that the global Phase 3 trial investigating intravenously administered Kevzara (sarilumab) at a dose of 200 mg or 400 mg[a] in severely or critically ill[b] patients hospitalized with COVID-19 did not meet its primary endpoint and key secondary endpoint[c] when Kevzara was compared to placebo added to usual hospital care. The 420-patient randomized trial was conducted outside the U.S. in Argentina, Brazil, Canada, Chile, France, Germany, Israel, Italy, Japan, Russia and Spain (86 in placebo, 161 in 200 mg, and 173 in 400 mg arms). "Although this trial did not yield the results we hoped for, we are proud of the work that was achieved by the team to further our understanding of the potential use of Kevzara for the treatment of COVID-19," said John Reed, M.D., Ph.D., Global Head of Research and Development, Sanofi. "In times like these, commitment to properly designed, controlled clinical trials, provides the information and understanding the scientific community needs for fact-based decision making. At Sanofi, we are committed to help combat the global COVID-19 pandemic, including developing vaccine candidates that can be manufactured at large-scale." Although not statistically significant, numerical trends were observed toward a decrease in duration of hospital stay as well as an acceleration in time to improve clinical outcomes, as measured by a 2-point improvement from baseline on the 7-point scale. Further, a trend was observed towards reduced mortality in the critical patient group which was not seen in the severe patient group. Finally, the time to discharge was shortened by 2-3 days (statistically non-significant) in the patients treated with Kevzara within the first two weeks of treatment. Source: West Corporation Jul 31, 2020: Banco Santander Sanofi and GSK selected for Operation Warp Speed to supply United States government with 100 million doses of COVID-19 vaccine Sanofi and GSK selected for Operation Warp Speed to supply United States government with 100 million doses of COVID-19 vaccine Promising vaccine candidate selected by U.S. government's Operation Warp SpeedU.S. government to provide funding up to $2.1 billion for development, including clinical trials and manufacturing scale-up, and delivery of an initial 100 million dosesOngoing discussions with the European Commission, with France and Italy on the negotiation team, and other governments to ensure global access to a novel coronavirus vaccine PARIS and LONDON - July 31, 2020 - Sanofi and GSK today announce a collaborative effort with the U.S. government to accelerate the development and manufacturing of a COVID-19 recombinant protein-based vaccine. The vaccine candidate, developed by Sanofi in partnership with GSK, is based on the recombinant protein-based technology used by Sanofi to produce an influenza vaccine, and GSK's established pandemic adjuvant technology. Collaborating with the U.S. Department of Health and Human Services (HHS) and Department of Defense will help fund the development activities and secure scale-up of Sanofi's and GSK's manufacturing capabilities in the United States for the recombinant protein-based, adjuvanted vaccine, resulting in a significant increase in capacity. The U.S. government will provide up to $2.1 billion, more than half of which is to support further development of the vaccine, including clinical trials, with the remainder used for manufacturing scale-up and delivery of an initial 100 million doses of the vaccine. Sanofi will receive the majority of the U.S. government funding. The U.S. government has a further option for the supply of an additional 500 million doses longer term. This helps the U.S. government's Operation Warp Speed goals of providing millions of doses of a safe and effective COVID-19 vaccine. Source: West Corporation Jul 31, 2020: Banco Santander Sanofi and GSK in advanced discussions with European Union to supply up to 300 million doses of COVID-19 vaccine Sanofi and GSK in advanced discussions with European Union to supply up to 300 million doses of COVID-19 vaccine Discussions relate to vaccine candidate using Sanofi's recombinant protein-based technology combined with GSK's pandemic adjuvant systemBoth companies are committed to making their COVID-19 vaccine affordable and available globally PARIS and LONDON - July 31, 2020 - Sanofi and GSK are in advanced discussions, with the European Commission (EC) for the supply of up to 300 million doses of a COVID-19 vaccine. The vaccine candidate developed by Sanofi in partnership with GSK, is based on the recombinant protein-based technology used by Sanofi to produce an influenza vaccine, and GSK's established adjuvant technology. The doses would be manufactured in European countries including France, Belgium, Germany and Italy. This marks a key milestone in protecting and serving the European population against COVID-19. "Today's announcement helps to ensure that millions of Europeans will have access to a potential vaccine protecting against COVID-19, once proven safe and effective. It has been our steadfast commitment to provide a vaccine that is affordable and accessible to everyone, and we are grateful to the European Commission for their ongoing engagement and shared support of this effort," said Thomas Triomphe, Executive Vice President and Global Head of Sanofi Pasteur. "Together with GSK, we are working relentlessly to develop and produce a vaccine to address this global health crisis." Source: West Corporation Jul 30, 2020: Banco Santander Nirsevimab reduced respiratory syncytial virus infections requiring medical care in healthy premature infants in Phase 2b trial Nirsevimab reduced respiratory syncytial virus infections requiring medical care in healthy premature infants in Phase 2b trial Nirsevimab reduced respiratory syncytial virus (RSV) lower respiratory tract infections by 70 percent and related hospitalizations by 78 percent1 Results published in New England Journal of MedicineThe investigative immunization demonstrated sustained protection across a typical five-month RSV season with a single dose1Sanofi will host a nirsevimab R&D investor event today at 5 p.m. CET/11 a.m. ET PARIS - July 30, 2020 - Detailed results from the positive Phase 2b trial for nirsevimab showed a significant reduction in medically attended lower respiratory tract infections (LRTI), mainly bronchiolitis and pneumonia, and hospitalizations caused by respiratory syncytial virus (RSV) in healthy preterm infants. Published in the New England Journal of Medicine, results from this trial demonstrate for the first time that a single dose monoclonal antibody can significantly reduce medically attended RSV LRTI in infants through the full RSV season.1 "The data for nirsevimab are exciting, as they highlight the potential for this innovative approach to protect infants from RSV with just one injection for the entire season," said Dr. Joseph Domachowske, study author, Professor of Pediatrics, Professor of Microbiology and Immunology, and Director of the Global Maternal-Child and Pediatric Health Program at the SUNY Upstate Medical University. "Nirsevimab offers the important potential to reduce hospitalizations and emergency department and in-office visits, which are a significant burden for healthcare systems." Source: West Corporation Jul 30, 2020: Banco Santander Online availability of Sanofi's half-year financial report for 2020 PARIS - July 29, 2020 - Sanofi announces that its half-year financial report for the period ending June 30, 2020 is now available and has been filed with the French market regulator Autorite des marches financiers (AMF) and submitted to the U.S. Securities and Exchange Commission (SEC) under form 6-K. Source: West Corporation Jul 29, 2020: Banco Santander Sanofi H1 2020 business EPS(1) growth of 9.2%(2) driven by transformation Q2 2020 sales results reflect the strong performance of Dupixent more than offset by COVID-19 related negative effects on Vaccines, General Medicines and CHC Source: West Corporation Jul 29, 2020: Banco Santander Sanofi and GSK agree with the UK government to supply up to 60 million doses of COVID-19 vaccine Sanofi and GSK agree with the UK government to supply up to 60 million doses of COVID-19 vaccine Agreement relates to vaccine candidate using Sanofi's recombinant protein-based technology combined with GSK's pandemic adjuvant systemBoth companies are committed to making their COVID-19 vaccine candidate affordable and available globallyOngoing discussions with the European Commission, with France and Italy on the negotiation team, and other governments to ensure global access to a novel coronavirus vaccine PARIS and LONDON - July 29, 2020 - Sanofi and GSK have reached an agreement, subject to final contract, with the UK government for the supply of up to 60 million doses of a COVID-19 vaccine. The vaccine candidate, developed by Sanofi in partnership with GSK, is based on the recombinant protein-based technology used by Sanofi to produce an influenza vaccine, and GSK's established pandemic adjuvant technology. "With our partner GSK, we are pleased to cooperate with the UK government as well as several other countries and global organizations as part of our ongoing efforts to develop a safe and effective vaccine and make it available as quickly as possible. We greatly appreciate the UK government's support of this shared vision," said Thomas Triomphe, Executive Vice President and Global Head of Sanofi Pasteur. Roger Connor, President of GSK Vaccines added, "We believe that this adjuvanted vaccine candidate has the potential to play a significant role in overcoming the COVID-19 pandemic, both in the UK and around the world. We thank the UK Government for confirmation of purchasing intent, which supports the significant investment we are already making as a company to scale up development and production of this vaccine." Source: West Corporation Jul 06, 2020: Banco Santander Availability of the Pre-quarterly Results Communication Availability of the Pre-quarterly Results Communication Paris, France - July 6, 2020 - Sanofi announced today that its Pre-Quarterly Results Communication document is available on the "Investors" page of the company's website: https://www.sanofi.com/en/investors/financial-results-and-events/financial-results/Q2-results-2020 Source: West Corporation Jul 02, 2020: Banco Santander Sanofi and Regeneron provide update on Kevzara (sarilumab) Phase 3 U.S. trial in COVID-19 patients Sanofi and Regeneron provide update on Kevzara (sarilumab) Phase 3 U.S. trial in COVID-19 patients PARIS and TARRYTOWN, N.Y. - July 2, 2020 - Sanofi and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Phase 3 trial of Kevzara (sarilumab) 400 mg in COVID-19 patients requiring mechanical ventilation did not meet its primary and key secondary endpoints when Kevzara was added to best supportive care compared to best supportive care alone (placebo). Minor positive trends were observed in the primary pre-specified analysis group (critical patients on Kevzara 400 mg who were mechanically ventilated at baseline) that did not reach statistical significance and these were countered by negative trends in a subgroup of critical patients who were not mechanically ventilated at baseline1. In the primary analysis group, adverse events were experienced by 80% of Kevzara patients and 77% of placebo patients. Serious adverse events that occurred in at least 3% of patients and more frequently among Kevzara patients were multi organ dysfunction syndrome (6% Kevzara, 5% placebo) and hypotension (4% Kevzara, 3% placebo). Based on the results, the U.S.-based trial has been stopped, including in a second cohort of patients who received a higher dose of Kevzara (800 mg). Detailed results will be submitted to a peer-reviewed publication later this year. The primary analysis group included 194 patients who were critically ill with COVID-19 and receiving mechanical ventilation at the time of enrolment. The primary endpoint assessed the percentage of patients who achieved at least a 1-point change from baseline on a 7-point scale, which consisted of 1) death; 2) hospitalized, requiring invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) hospitalized, requiring non-invasive ventilation or high flow oxygen devices; 4) hospitalized, requiring supplemental oxygen; 5) hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) discharged from hospital. A second cohort, which was partially recruited (n=27), compared Kevzara 800 mg versus placebo. Source: West Corporation Jun 23, 2020: Banco Santander Sanofi and Translate Bio expand collaboration to develop mRNA vaccines across all infectious disease areas Sanofi and Translate Bio expand collaboration to develop mRNA vaccines across all infectious disease areas The two companies will build upon their existing collaboration to pursue novel mRNA vaccines aimed at broadly addressing current and future infectious diseasesTranslate Bio to receive $425 million in upfront payment and common stock equity investment and overall is eligible to receive up to $1.9 billion of potential milestones/payments as well as tiered royalties on worldwide sales of developed vaccinesSanofi to receive exclusive worldwide rights to develop, manufacture and commercialize infectious disease vaccines using Translate Bio technologyThe expanded collaboration brings together Translate Bio's leading mRNA technology and manufacturing with Sanofi's world class vaccine development and distribution PARIS and LEXINGTON, MASS. - June 23, 2020 - Sanofi Pasteur, the vaccines global business unit of Sanofi, and Translate Bio (NASDAQ: TBIO), a clinical-stage messenger RNA (mRNA) therapeutics company, have agreed to expand their existing 2018 collaboration and license agreement to develop mRNA vaccines for infectious diseases. The expansion of this agreement will further unite Translate Bio's expertise and knowledge from more than 10 years of mRNA research and development with Sanofi's leadership in vaccine research and development. Under the expansion agreement, Translate Bio will receive a total upfront payment of $425 million, consisting of a $300 million cash payment and a private placement common stock investment of $125 million at $25.59 per share representing a 50 percent premium to the 20-day moving average share price prior to signing. Translate Bio will also be eligible for potential future milestones and other payments up to $1.9 billion, including $450 million of milestones under the 2018 agreement. Of these potential milestones and other payments, approximately $360 million are anticipated over the next several years, inclusive of COVID-19 vaccine development milestones. In addition, Translate Bio is also eligible to receive tiered royalty payments based upon worldwide sales of the developed vaccines. Sanofi Pasteur will pay for all costs during the collaboration term. Under this agreement Sanofi Pasteur will receive exclusive worldwide rights for infectious disease vaccines. Source: West Corporation Jun 23, 2020: Banco Santander Sanofi's virtual R&D Day event to highlight capabilities, platforms, and expertise in disease pathways to deliver potentially transformative treatments to patients Sanofi's virtual R&D Day event to highlight capabilities, platforms, and expertise in disease pathways to deliver potentially transformative treatments to patients R&D strategy driving pipeline momentum, productivity and innovationSignificant progress made since December 2019 on priority pipeline programs that have the potential to transform patient careFirst multiple sclerosis patient has been enrolled in the Phase 3 program for brain penetrant BTK inhibitor '168Positive THOR-707 "not-alpha" IL-2 first-in-human biomarker data Accelerated development timeline for COVID-19 recombinant protein-based vaccine with potential approval in H1 2021Virtual R&D Day investor event today from 3:00-5:30 pm CET / 9:00-11:30 am ET PARIS - June 23, 2020 - Sanofi Chief Executive Officer Paul Hudson, Global Head of R&D John Reed, M.D., Ph.D., and members of the R&D and commercial leadership teams will provide an update on Sanofi's approach to deliver potentially transformative medicines to patients. This event is the fourth of a five-part series highlighting how Sanofi is leading with innovation. The previous three events focused on the Phase 2 results of Sanofi's brain penetrant BTK inhibitor ('168), Sanofi's oncology pipeline progress, and future growth opportunities for Dupixent (dupilumab)1. "Since last December, we have been making tremendous progress on our ability to grow a pipeline of potentially transformative treatments through a unique, adaptive strategy that best positions Sanofi to deliver on our goal of bringing practice-changing medicines and vaccines to patients," said Paul Hudson, Chief Executive Officer, Sanofi. "While we have greatly accelerated our efforts across six priority development programs, the momentum we are seeing can be found across our entire pipeline. This is largely driven by how we are leveraging our innovative technology platforms and the deep insights we have gained into patients' needs and disease pathways." Source: West Corporation Jun 19, 2020: Banco Santander Sanofi announces positive long-term efficacy and safety data for fitusiran from interim analysis of Phase 2 extension study in people with hemophilia A and B, with or without inhibitors Sanofi announces positive long-term efficacy and safety data for fitusiran from interim analysis of Phase 2 extension study in people with hemophilia A and B, with or without inhibitors Fitusiran, a novel RNAi therapy in development, has the potential to transform the treatment of hemophilia with a monthly, subcutaneous treatment for people with hemophilia A and B, with or without inhibitors Long-term exploratory data show prophylactic treatment with fitusiran provides a sustained reduction in annual bleed rates in moderate to severe hemophilia A and B patients, with or without inhibitors. Paris - June 19, 2020 - New data exploring the efficacy and safety of fitusiran, an investigational once-monthly, subcutaneously administered RNA interference (RNAi) therapy for the treatment of hemophilia A and B, with or without inhibitors, were shared today in a late-breaking presentation at the World Federation of Hemophilia Virtual Summit. Long-term interim results from the Phase 2 open-label extension (OLE) study reinforce fitusiran's potential to restore hemostatic balance and to lower annualized bleed rates (ABRs) over a period up to 57 months. "These new interim data support the potential of fitusiran to have a transformative impact on hemophilia management with the aim to provide patients with consistent bleed protection and only once monthly subcutaneous dosing," said Dietmar Berger, Global Head of Development, Sanofi. "We are continuing to advance our portfolio of factor and non-factor therapies that could offer people with hemophilia a broad range of therapeutic options to fit their individual needs. We continue to investigate the clinical profile of fitusiran in our Phase 3 ATLAS program with results expected in the first half of 2021 and look forward to offering this novel therapy to patients globally." Source: West Corporation Jun 19, 2020: Banco Santander Dupixent (dupilumab) approved in China for adults with moderate-to-severe atopic dermatitis Dupixent (dupilumab) approved in China for adults with moderate-to-severe atopic dermatitis Dupixent included in China's list of overseas approved drugs that meet urgent clinical need Dupixent is approved in 60 countries for adults with moderate-to-severe atopic dermatitis, one of the diseases driven by type 2 inflammation PARIS and TARRYTOWN, NY - June 19, 2020 - The National Medical Products Administration (NMPA) in China has approved Dupixent (dupilumab) for the treatment of moderate-to-severe atopic dermatitis in adults whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. The NMPA identified Dupixent as an overseas medicine considered urgently needed in clinical practice, leading to an expedited review and approval process. "The limited treatment options in China for moderate-to-severe atopic dermatitis has left many patients and those who care for them coping with the physical and emotional burden of the disease," said Professor Zhang Jianzhong, chairman of the 13th session of the Dermatology and Venereology Branch of the Chinese Medical Association, and director of the Department of Dermatology, Peking University People's Hospital. "The availability of a targeted treatment like Dupixent provides hope to those seeking relief from the often-unbearable itch and other symptoms that can significantly impact the lives of adults living with this chronic disease." Atopic dermatitis is a chronic inflammatory disease that often appears as a rash on the skin. Moderate-to-severe atopic dermatitis is characterized by rashes that can potentially cover much of the body, and can include intense, persistent itching, skin dryness and skin lesions including cracking, redness or darkness, crusting and oozing. Itch is one of the most burdensome symptoms for patients and can be debilitating. Inadequately controlled atopic dermatitis can have a physical, emotional and psychosocial impact, causing sleep disturbance, symptoms of anxiety and depression, and feelings of isolation. Source: West Corporation Jun 16, 2020: Banco Santander Sanofi invests to make France its world class center of excellence in vaccine research and production Sanofi invests to make France its world class center of excellence in vaccine research and production Sanofi will invest more than half a billion euros to create a state-of-the-art vaccine production site (Neuville sur Saone) and a new research center (Marcy-l'Etoile) dedicated to vaccinesThe investments will strengthen Sanofi's leadership and capacity to advance the research of new innovative vaccines and produce them on a massive scale, in line with the corporate strategyThe innovative technologies of these new facilities will also provide Sanofi with the flexibility and agility needed to quickly respond to future pandemic risks PARIS - June 16, 2020 - Sanofi today detailed plans on how the Company will make significant investments in France to increase its vaccines research and production capacities, and contribute in responding to future pandemic risks. Aligned with its corporate strategy presented last December, Sanofi will invest EUR610 million to create a new production site and research center in France with both dedicated to vaccines. "Sanofi's heart beats in France. We have a long history and exceptional teams working throughout the country, embodying our strong values. By investing in a new industrial site and a R&D center, Sanofi positions France at the core of its strategy, aiming to make France a world-class center of excellence in vaccine research and production," said Paul Hudson, Chief Executive Officer at Sanofi. "Sanofi is a major healthcare player in France, in Europe, and worldwide. It is our responsibility to focus our resources and expertise against the current pandemic, but also to invest in preparing for future ones. We welcome the ongoing collaboration and commitment of the French authorities who we have been working alongside with the last several months to achieve this." Source: West Corporation Jun 11, 2020: Banco Santander Sanofi to present growth opportunities and development strategy for Dupixent (dupilumab) in type 2 inflammatory diseases Sanofi to present growth opportunities and development strategy for Dupixent (dupilumab) in type 2 inflammatory diseases Additional data contribute to the growing body of evidence demonstrating Dupixent's best in class safety profile combined with strong efficacy benefit for atopic dermatitis and further validate it as a standard of care treatment for asthma Dupixent's unique mechanism of action simultaneously inhibits IL-4 and IL-13, which play a key role in type 2 inflammation in multiple diseases Recent evidence further supports additional clinical uses in diseases driven by type 2 inflammation including Eosinophilic Esophagitis and a subset of Chronic Obstructive Pulmonary Disease PARIS - June 11, 2020 - Sanofi commercial and R&D executives will provide an overview of the growth and development strategy for Dupixent (dupilumab) in the third of its five-part series to highlight Sanofi's progress in R&D. As announced in December 2019, Sanofi expects to deliver strong growth for Dupixent with the ambition of achieving more than EUR10 billion in peak sales driven by its selective mechanism of action targeting the type 2 inflammation pathway. Sanofi co-develops and co-commercializes Dupixent with Regeneron. "By specifically targeting IL-4 and IL-13, Dupixent's mechanism of action is uniquely suited to help address conditions driven by type 2 inflammation," said John Reed, M.D., Ph.D., Global Head of Research and Development, Sanofi. "While atopic dermatitis and asthma are the foundational diseases where Dupixent was first approved for use, great opportunity exists across multiple diseases where type 2 inflammation plays a role. We are therefore aggressively pursuing clinical evaluation of additional indications where patients are urgently awaiting solutions for their unmet medical needs." Source: West Corporation Jun 08, 2020: Banco Santander Sanofi to present Phase 3 results of avalglucosidase alfa in patients with late-onset Pompe disease Sanofi to present Phase 3 results of avalglucosidase alfa in patients with late-onset Pompe disease Virtual scientific session June 16, 2020, 8:00-9:00am ET/2:00-3:00pm CETAvalglucosidase alfa receives FDA Breakthrough Therapy designation PARIS - June 8, 2020 - Sanofi will host a virtual scientific session to present data from the Phase 3 COMET trial of investigational enzyme replacement therapy (ERT) avalglucosidase alfa in patients with late-onset Pompe disease (LOPD). The session, open to healthcare professionals and members of the media, will include a data presentation by Jordi Diaz-Manera, M.D., Ph.D., Professor of Neuromuscular Disorders, Translational Medicine and Genetics at the John Walton Muscular Dystrophy Research Center, Newcastle University, UK, and Professor of Neuromuscular Diseases, Translational Medicine and Genetics in the Neuromuscular Diseases Unit, Neurology department of Hospital de la Santa Creu, Barcelona, Spain. The presentation will be followed by a Q&A session moderated by Alaa Hamed, M.D., MPH, MBA, Global Head of Medical Affairs, Rare Diseases at Sanofi. The scientific session, endorsed by the COMET trial author group, is being scheduled as a result of the postponement of the July 2020 International Congress on Neuromuscular Diseases (ICNMD) due to the COVID-19 pandemic. Data from the Phase 3 COMET trial would have been presented at the July 2020 ICNMD. Pre-registration is required for the June 16, 2020 scientific session. Please click here to register. Source: West Corporation Jun 02, 2020: Banco Santander European Commission approves Sarclisa (isatuximab) for adults with relapsed and refractory multiple myeloma European Commission approves Sarclisa (isatuximab) for adults with relapsed and refractory multiple myeloma EC approval based on data from first randomized Phase 3 trial (ICARIA-MM) to report results evaluating an anti-CD38 monoclonal antibody combined with pomalidomide and dexamethasone (pom-dex) Sarclisa in combination with pom-dex significantly reduced the risk of progression or death by 40% versus pom-dex alone Multiple myeloma is the second most common blood cancer, with approximately 40,000 new cases per year in Europe PARIS - June 2, 2020 - The European Commission (EC) has approved Sarclisa (isatuximab) in combination with pomalidomide and dexamethasone (pom-dex) for the treatment of adult patients with relapsed and refractory multiple myeloma (MM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on the last therapy. Sarclisa is a monoclonal antibody (mAb) that binds to a specific epitope on the CD38 receptor of MM cells. "The EC approval of Sarclisa represents an important additional therapeutic option and may set a new standard of care for myeloma patients in Europe who are in need of new effective treatments because their disease has returned or they have become refractory to their previous treatment," said John Reed, M.D., Ph.D., Global Head of Research and Development at Sanofi. "Sarclisa in combination with pom-dex demonstrated median progression-free survival of nearly one year, a five-month improvement over pom-dex alone, in patients who had already failed at least two prior therapies." Source: West Corporation Jun 02, 2020: Banco Santander Sarclisa (isatuximab) combination therapy demonstrated superior progression free survival and clinically meaningful depth of response in patients with relapsed multiple myeloma Sarclisa (isatuximab) combination therapy demonstrated superior progression free survival and clinically meaningful depth of response in patients with relapsed multiple myeloma Sarclisa added to carfilzomib and dexamethasone (Sarclisa combination) reduced risk of disease progression or death by 47% versus standard of care carfilzomib and dexamethasone (Kd) aloneSarclisa combination therapy delivered considerable depth of response, with undetectable levels of multiple myeloma (MM) in nearly 30% of patients with relapsed MM (MRD-negative 10-5 sensitivity) Results from first planned interim analysis of the Phase 3 IKEMA trial selected as late-breaking presentation at EHA25 Virtual Congress PARIS - June 2, 2020 - Sarclisa (isatuximab) added to carfilzomib and dexamethasone (Sarclisa combination therapy) reduced the risk of disease progression or death by 47% (hazard ratio 0.531, 99% CI 0.318-0.889, p=0.0007, n=179) compared to standard of care carfilzomib and dexamethasone (Kd) in patients (n=123) with relapsed multiple myeloma (MM). Sarclisa combination therapy compared to Kd alone showed a treatment benefit consistent across multiple subgroups. These results from the Phase 3 IKEMA trial follow the topline announcement on May 12, 2020 that Sarclisa combination therapy met the trial primary endpoint at the pre-planned interim analysis. Interim results will be presented during the late-breaking session of the European Hematology Association (EHA) Virtual Congress (EHA25) on June 14, 2020 and will form the basis for global regulatory submissions later this year. Source: West Corporation Jun 02, 2020: Banco Santander Sanofi to present oncology strategy, provide update on portfolio and emerging pipeline Sanofi to present oncology strategy, provide update on portfolio and emerging pipeline PARIS - April 2, 2020 - Sanofi Chief Executive Officer Paul Hudson along with R&D and commercial leaders will provide an overview of Sanofi's oncology strategy and progress update of its related key products and pipeline programs. Sanofi's oncology strategy is focused on four core therapeutic areas with four anchor treatments the company believes have the potential to transform patient care. The four areas of strategic focus within oncology, including multiple myeloma, skin, lung, and breast cancers. Sanofi's four anchor oncology treatments include Sarclisa (isatuximab-irfc), an anti-CD38 monoclonal antibody and Libtayo (cemiplimab-nwlc), a PD-1 checkpoint inhibitor1 and the pipeline programs - an investigational anti-CEACAM 5 antibody drug conjugate and SERD ('859), an investigational oral selective estrogen receptor degrader. "We are rapidly building momentum with the execution of our oncology strategy, with several developments on both our pipeline and marketed treatments. Additionally, we are assembling a world-class development and marketing team to support our growth in this core area," said Hudson. "We believe our efforts and treatments have the potential to make a significant difference in the lives of people living with cancer." "We've developed a focused oncology strategy, and are making significant clinical progress to support our ambitions," said John Reed, M.D., Ph.D., Global Head of Research and Development at Sanofi. "With a deep toolbox of therapeutic platforms enabling us to discover highly differentiated molecules, Sanofi has a tremendous opportunity to continue our momentum and build a sustainable presence in oncology." Source: West Corporation May 29, 2020: Banco Santander Sanofi names new leaders to Executive Committee Sanofi names new leaders to Executive Committee Natalie Bickford appointed Chief People OfficerArnaud Robert appointed Chief Digital Officer Julie Van Ongevalle appointed Head of Consumer Healthcare Thomas Triomphe appointed Head of Sanofi Pasteur PARIS - May 29, 2020 - Sanofi has named four new leaders to its Executive Committee. These appointments now complete the announced changes in February to further simplify the Company's executive leadership team. The complete Sanofi Executive Committee now includes the four heads of the Company's global business units (Sanofi Genzyme, Sanofi Pasteur, General Medicines, and Consumer Healthcare) as well as the global Heads of Research and Development, Industrial Affairs, Finance, Human Resources, Legal and Digital. "My objective has been to find the right blend of talented people that can make the whole team stronger than its individual parts. Sanofi needs people who can bring us new insights from the outside of the industry as well as people with world-class pharma expertise. We need leaders who come to Sanofi with a fresh perspective as well as leaders who have grown up within the company," says Paul Hudson, Chief Executive Officer at Sanofi. "I am confident in this team's capacity to inspire our people, execute our strategy and change the practice of medicine for patients." Natalie Bickford, Executive Vice President, Chief People Officer Natalie Bickford starts on August 1, and joins Sanofi from Merlin Entertainments, the world's second largest location-based entertainment business (which includes Legoland Resorts, Madame Tussaud's, SEALIFE aquariums, among other brands). At Merlin, she was responsible for 30,000 employees across Europe, North America, and Asia Pacific. Ms. Bickford brings a wealth of consumer-facing experience. She held previous Human Resources leadership positions at Sodexo, AstraZeneca, and Kingfisher, has consistently demonstrated passion for engaging teams and driving change in behaviors and culture. She also has a solid track record of transforming organizations, with a strong focus on inclusion and diversity. Source: West Corporation May 29, 2020: Banco Santander Sanofi announces closing of Regeneron stock sale Sanofi announces closing of Regeneron stock sale PARIS - May 29, 2020 - Sanofi today announced the closing of its sale of 13.0 million shares of Regeneron (NASDAQ: REGN) common stock through a registered offering at a public offering price of $515.00 per share. This includes the previously announced overallotment option that has been fully exercised by underwriters. In addition, Sanofi announced the completion of Regeneron's repurchase of 9.8 million shares or approximately $5 billion in common stock directly from Sanofi. As a result of the offering, Sanofi has sold its entire equity investment in Regeneron, (excluding 400,000 Regeneron shares, which Sanofi is retaining) for total gross proceeds amounting to $11.7 billion. The registered offering and share repurchase will have no impact on the ongoing collaboration between Sanofi and Regeneron. The Companies have had a successful and long-standing clinical and commercial collaboration dating back to 2003 that has resulted in five approved treatments to date with additional candidates currently in clinical development. The registered offering was executed simultaneously in the United States and internationally through underwriters led by BofA Securities and Goldman Sachs & Co. LLC, together with Barclays, BNP PARIBAS, Citigroup, J.P. Morgan, Morgan Stanley as joint book-running managers. The shares offered to the public are offered pursuant to an existing effective shelf registration statement (including a base prospectus) that has been filed by Regeneron with the U.S. Securities and Exchange Commission (the "SEC"). A prospectus supplement relating to and describing the terms of the offering has been filed by Regeneron with the SEC and is available on the SEC website at www.sec.gov. Alternatively, any underwriter or any dealer participating in the offering will arrange to send you the prospectus and the prospectus supplement if you request them by contacting: (1) BofA Securities, NC1-004-03-43, 200 North College Street, 3rd Floor, Charlotte, NC 28255-0001, Attention: Prospectus Department or by email at dg.prospectus_requests@bofa.com, or (2) Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, New York 10282, via telephone: 1-866-471-2526, or via email: prospectus-ny@ny.email.gs.com. Source: West Corporation May 29, 2020: Banco Santander Libtayo (cemiplimab-rwlc) longer-term results in advanced cutaneous squamous cell carcinoma presented at ASCO 2020 show durable responses that deepen over time Libtayo (cemiplimab-rwlc) longer-term results in advanced cutaneous squamous cell carcinoma presented at ASCO 2020 show durable responses that deepen over time *Across all groups combined, complete responses (CR) are now 16%; in the metastatic group with the longest follow-up, CRs are 20% representing a 200% increase over two years PARIS and TARRYTOWN, N.Y. - May 29, 2020 - New, longer-term data were shared today for PD-1 inhibitor Libtayo (cemiplimab-rwlc) from a pivotal Phase 2 trial in advanced cutaneous squamous cell carcinoma (CSCC), the deadliest non-melanoma skin cancer. These results demonstrate both longer durability and higher complete response (CR) rates than previously reported. Furthermore, the data make up part of the largest and most mature prospective clinical dataset in patients with metastatic CSCC (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or radiation. The data were presented during the virtual 2020 American Society of Clinical Oncology (ASCO) Annual Meeting. "The three-year follow-up data demonstrate significant long-term outcomes with Libtayo, which is now standard-of-care for patients with advanced CSCC in many countries," said Dr. Danny Rischin, Director, Department of Medical Oncology at Peter MacCallum Cancer Centre, Victoria, Australia. "The Libtayo data on duration of response and overall survival provide new insights into the longer-term treatment of advanced CSCC, with the median still not reached for either measure. Remarkably, it is exciting to see the number of complete responses increase with longer follow-up, which reinforces the potential ongoing benefit of Libtayo treatment in this aggressive skin cancer." Source: West Corporation May 26, 2020: Banco Santander Sanofi: FDA approves Dupixent (dupilumab) as first biologic medicine for children aged 6 to 11 years with moderate-to-severe atopic dermatitis FDA approves Dupixent (dupilumab) as first biologic medicine for children aged 6 to 11 years with moderate-to-severe atopic dermatitis In the pivotal trial, more than twice as many children achieved clear or almost clear skin and more than four times achieved itch reduction with Dupixent plus topical corticosteroids (TCS) compared to TCS aloneThree-quarters of patients receiving Dupixent achieved at least a 75% improvement in overall disease, with an average improvement of approximately 80%Safety consistent with the established safety profile of Dupixent across adult and adolescent atopic dermatitis patients PARIS and TARRYTOWN, N.Y. - May 26, 2020 - The U.S. Food and Drug Administration (FDA) approved Dupixent (dupilumab) for children aged 6 to 11 years with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Dupixent is the only biologic medicine approved for this patient population. "This FDA approval is another milestone in the journey for Dupixent as an innovative biologic treatment for atopic dermatitis and other conditions driven in part by type 2 inflammation," said John Reed, M.D., Ph.D., Global Head of Research and Development at Sanofi. "Caregivers of children with moderate-to-severe atopic dermatitis and their physicians now have access to a first-in-class biologic with a proven safety profile, a factor that often plays a critical role in treatment decisions for younger patients. Additionally, improvements in itch and disease severity were observed as early as two weeks after the first dose and continued throughout active treatment, which is important for these children and their families." Source: West Corporation May 26, 2020: Banco Santander Sanofi announces pricing of Regeneron stock offering Sanofi announces pricing of Regeneron stock offering Sanofi announces sale of 21.6 million shares held in RegeneronGross proceeds of $11.1 billion to Sanofi to further Company's ability to execute innovation and growth strategy PARIS - May 26, 2020 - Sanofi today announced that it has agreed to sell 11.8 million shares of Regeneron, Inc. (NASDAQ: REGN) common stock through a registered offering at a price of $515.00 per share. As previously announced, Regeneron will repurchase 9.8 million shares or $5 billion in common stock from Sanofi at the offering price less the underwriting discount. Sanofi expects to use the net proceeds of the offering and the repurchase to further execute on its strategy to drive innovation and growth. In connection with the offering, the underwriters have been granted an option to purchase up to 1.2 million additional Regeneron shares at the price payable by the underwriters in the offering, exercisable within the next 30 days. If the option is fully exercised, the offering and repurchase will together result in gross proceeds to Sanofi of $11.7 billion and the sale of Sanofi's entire holding in Regeneron, excluding 400,000 Regeneron shares that Sanofi is retaining. The public offering is occurring simultaneously in the United States and internationally through underwriters led by BofA Securities and Goldman Sachs, together with Barclays, BNP Paribas, Citigroup, J.P. Morgan, Morgan Stanley as joint book-running managers. The shares offered to the public are being offered pursuant to an existing effective shelf registration statement (including a base prospectus) that has been filed by Regeneron with the U.S. Securities and Exchange Commission (the "SEC"). Before you invest, you should read the prospectus in that registration statement and other documents Regeneron has filed with the SEC, including the preliminary prospectus supplement dated May 26, 2020, for more complete information about Regeneron and this offering. You may get these documents for free by visiting EDGAR on the SEC website at www.sec.gov. Alternatively, any underwriter or any dealer participating in the offering will arrange to send you the prospectus and the prospectus supplement, when available, if you request them by contacting: (1) BofA Securities, NC1-004-03-43, 200 North College Street, 3rd Floor, Charlotte, NC 28255-0001, Attention: Prospectus Department or by email at dg.prospectus_requests@bofa.com, or (2) Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, New York 10282, via telephone: 1-866-471-2526, or via email: prospectus-ny@ny.email.gs.com. Source: West Corporation May 25, 2020: Banco Santander Sanofi intends to sell its equity investment in Regeneron; confirms no change to ongoing collaboration Sanofi intends to sell its equity investment in Regeneron; confirms no change to ongoing collaboration PARIS - May 25, 2020 - Sanofi today announced its intent to sell its equity investment in Regeneron (NASDAQ: REGN) through a registered public offering and related share repurchase by Regeneron. The registered offering and share repurchase will have no impact on the ongoing collaboration between Sanofi and Regeneron. A preliminary prospectus supplement relating to the offering of Regeneron's shares will be filed with the U.S. Securities and Exchange Commission. Sanofi currently holds approximately 23.2 million shares of Regeneron's common stock, representing approximately 20.6% ownership. Regeneron has agreed to repurchase $5 billion of its stock from Sanofi conditional on completion of the proposed public offering. If the offering and repurchase are completed and the underwriters fully exercise their option to purchase additional shares1, Sanofi will continue to own approximately 400,000 shares of Regeneron's common stock, which Sanofi is retaining in support of the ongoing collaboration with Regeneron. "Sanofi and Regeneron's collaboration has been one of the most productive in the industry, creating significant value for both companies but more importantly, resulting in five important medicines for patients. Sanofi remains committed to continuing our collaboration with Regeneron which remains an integral part of our overall strategy, and this decision was fully aligned with Regeneron, said Paul Hudson, Chief Executive Officer, Sanofi. "The decision to divest our holdings is consistent with our efforts to enhance value creation for our shareholders. We believe the proceeds from this transaction will help further our ability to execute on our strategy to drive innovation and growth." Source: West Corporation May 22, 2020: Banco Santander Dupixent (dupilumab) eosinophilic esophagitis trial meets both co-primary endpoints Dupixent (dupilumab) eosinophilic esophagitis trial meets both co-primary endpoints Dupixent demonstrated significant clinical and anatomic improvements, including the ability to swallow, in Part A of pivotal trial69% reduction in disease symptoms with Dupixent, compared to 32% for placebo (p=0.0002)There are currently no FDA-approved treatments for eosinophilic esophagitis, a condition that impacts patients' ability to eat PARIS and TARRYTOWN, N.Y. - May 22, 2020 - Sanofi and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced positive results from Part A of the pivotal Phase 3 trial evaluating Dupixent (dupilumab) in patients 12 years and older with eosinophilic esophagitis (EoE). The trial met both of its co-primary endpoints, as well as all key secondary endpoints. Dupixent is the first and only biologic to show positive and clinically-meaningful results in this population as part of a Phase 3 trial. An ongoing Part B portion of the Phase 3 trial evaluates an additional Dupixent dosing regimen. EoE is a chronic and progressive type 2 inflammatory disease that damages the esophagus and prevents it from working properly, leading to difficulties swallowing. If untreated, symptoms and inflammation can progress, causing functional damage and scarring of the esophagus. EoE can lead to esophageal food impaction, requiring immediate emergency room visits. Almost half of the patients in this trial had prior procedures such as dilation of their esophagus, and almost three-quarters had previously been treated with corticosteroids. In the U.S., there are approximately 160,000 patients with EoE who are currently treated, of which an estimated 50,000 have failed multiple treatments.There are currently no therapies approved by the U.S. Food and Drug Administration (FDA). Source: West Corporation May 18, 2020: Banco Santander Sanofi to highlight pipeline programs in a series of interactive virtual sessions leading to a R&D day event Sanofi to highlight pipeline programs in a series of interactive virtual sessions leading to a R&D day event Upcoming R&D sessions on oncology, Dupixent (dupilumab), and nirsevimabInitial session focused on brain-penetrant BTKi '168 Phase 2 dataVirtual R&D day event on June 23 to showcase Sanofi's industry leading platforms, unique capabilities, and innovative medicines to fuel future growth PARIS - May 18, 2020 - Sanofi announced today that it is hosting a series of interactive webcast events highlighting key priority pipeline programs that will conclude with the company's virtual R&D day event on Tuesday, June 23. The five-part webcast series was initiated with the presentation of the Phase 2 results and Sanofi's development strategy for its brain-penetrant BTKi'168 for multiple sclerosis in April. Upcoming sessions will discuss Sanofi's oncology strategy, line extension plans for Dupixent (dupilumab), and nirsevimab, the first time a monoclonal antibody potentially offers a population-based solution to prevent respiratory syncytial virus (RSV) for all infants. "Over the coming weeks, we look forward to sharing the tremendous progress we've made in advancing our priority molecules and building a sustainable R&D engine," said John Reed, Global Head of Research and Development at Sanofi. "With a great team, deep therapeutic area expertise and an expanding toolbox of therapeutic platforms, Sanofi is poised to discover the next generation of life-changing medicines." Source: West Corporation May 14, 2020: Banco Santander FDA grants priority review of sutimlimab, potential first approved treatment of hemolysis in adult patients with Cold Agglutinin Disease FDA grants priority review of sutimlimab, potential first approved treatment of hemolysis in adult patients with Cold Agglutinin Disease *Sutimlimab targets C1-activated hemolysis in cold agglutinin disease (CAD) PARIS - May 14, 2020 - The U.S. Food and Drug Administration (FDA) has granted priority review of Sanofi's Biologics License Application (BLA) for sutimlimab for the treatment of hemolysis in adult patients with cold agglutinin disease (CAD). Sutimlimab, an investigational monoclonal antibody, targets the underlying cause of hemolysis in CAD by selectively inhibiting complement C1s. If approved, sutimlimab would be the first and only approved treatment for these patients. The target action date for the FDA decision is November 13, 2020. CAD is a chronic autoimmune hemolytic anemia that causes the body's immune system to mistakenly attack healthy red blood cells and cause their rupture (hemolysis). CAD patients may experience chronic anemia, profound fatigue, acute hemolytic crisis, and other potential complications, including an increased risk of thromboembolic events and early death.1,2,3 An estimated 5,000 people in the U.S. live with CAD. "People living with cold agglutinin disease currently have no approved treatment option and experience chronic anemia and profound fatigue, which have a persistent and serious impact on their lives," said John Reed, M.D., Ph.D., Global Head of Research and Development at Sanofi. "Results from our 26-week pivotal Phase 3 study clearly demonstrated that sutimlimab had a clinically meaningful effect on complement-mediated hemolysis, which is the cause of anemia and fatigue. If approved, sutimlimab will be the first and only FDA-approved treatment to uniquely address C1-activated hemolysis and help alleviate the chronic disease burden for people with CAD." Source: West Corporation Share Capital 2024 Mar 15, 2024: Banco Santander Sanofi: Information concerning the total number of voting rights and shares - February 2024 Information concerning the total number of voting rights and shares, provided pursuant to article L. 233-8 II of the Code de commerce (the French Commercial Code) and article 223-16 of the Reglement general de lAutorite des Marches Financiers (Regulation of the French stock market authority) Sanofia French societe anonyme with a registered share capital of 2,529,599,938 Registered office : 46, avenue de la Grande Armee - 75017 Paris - FranceRegistered at the Paris Commercial and Companies Registry under number 395030844 Source: West Corporation Feb 20, 2024: Banco Santander Sanofi: Information concerning the total number of voting rights and shares - January 2024 Information concerning the total number of voting rights and shares, provided pursuant to article L. 233-8 II of the Code de commerce (the French Commercial Code) and article 223-16 of the Reglement general de lAutorite des Marches Financiers (Regulation of the French stock market authority) Sanofia French societe anonyme with a registered share capital of 2,529,599,938 Registered office : 46, avenue de la Grande Armee - 75017 Paris - FranceRegistered at the Paris Commercial and Companies Registry under number 395030844 Source: West Corporation 2023 Jul 18, 2023: Banco Santander Sanofi: Information concerning the total number of voting rights and shares June 2023 Information concerning the total number of voting rights and shares, provided pursuant to article L. 233-8 II of the Code de commerce (the French Commercial Code) and article 223-16 of the Reglement general de lAutorite des Marches Financiers (Regulation of the French stock market authority) Sanofia French societe anonyme with a registered share capital of 2,521,494,572 Registered office : 46, avenue de la Grande Armee - 75017 Paris - FranceRegistered at the Paris Commercial and Companies Registry under number 395030844 Source: West Corporation Jun 20, 2023: Banco Santander Sanofi: Information concerning the total number of voting rights and shares - May 2023 Information concerning the total number of voting rights and shares, provided pursuant to article L. 233-8 II of the Code de commerce (the French Commercial Code) and article 223-16 of the Reglement general de lAutorite des Marches Financiers (Regulation of the French stock market authority) Sanofia French societe anonyme with a registered share capital of 2,521,494,572 Registered office : 46, avenue de la Grande Armee - 75017 Paris - FranceRegistered at the Paris Commercial and Companies Registry under number 395030844 Source: West Corporation Jun 01, 2023: Banco Santander Press Release: Sanofi launches 2023 global Employee Stock Purchase Plan Sanofi launches 2023 global Employee Stock Purchase Plan Paris, June 1 2023. Sanofi launches Action 2023, its global employee shareholder plan, open to around 86,000 employees in 56 countries. The program builds on plans carried out since 2013 and demonstrates the ongoing commitment of Sanofi and its Board of Directors to involve all employees, across all its territories, in the future development and results of the company. Paul HudsonChief Executive Officer of Sanofi "This plan represents our desire to unite employees around a collective company performance, enabling them to feel truly invested in our growth story. Together with the Board of Directors, we believe the year over year increase in the plans participation clearly shows the commitment of our employees to the long-term success of Sanofi and our ambition to transform the practice of medicine. Starting June 5th , the shares will be offered at a subscription price of 79,58, which is equal to a 20% discount on the average of the 20 opening prices of Sanofi shares from May 3 to May 30th, 2023. For every five shares subscribed, employees will be able to receive one free matching share (up to a maximum of four matching shares per employee). Each employee will be able to purchase up to 1,500 Sanofi shares within the legal limit of a maximum payment amount that does not exceed 25% of their gross annual salary, minus any voluntary deductions already made under employee savings schemes (Group Savings Plan and/or Group Retirement Savings Plan) during the year 2023. In 2022, the employee share ownership plan was open to over 85,000 employees in 59 countries with a growing overall uptake rate of 38.5% (vs 37.5% in 2021). More than 32,800 Sanofi employees chose to invest in the company. Today, nearly 75,000 current or former employees of the company are shareholders of Sanofi, and hold approximately 2%1 of its capital. Detailed conditionsAn eligibility condition of three months employment by the closing date of the offer period will apply. Eligible staff will be able to subscribe shares 5th June 2023 (inclusive) to 23rd June 2023 (inclusive). The issue is expected to be completed and the delivery of the securities carried out by the end of July 2023.The maximum number of Sanofi shares that may be issued under this offer is 10,580,415 shares (corresponding to a maximum capital increase of 21,160,831 at nominal value, being 1% of share capital less the amount of the capital increase carried out on July 26th, 2022) The new shares, including the matching shares (the "Shares"), will be subscribed (or delivered) either directly or through the intermediary of employee mutual funds ("FCPE"), depending on the regulations and/or tax regime applicable in the various countries of residence of those eligible for the capital increase. The Shares will be fully fungible with the existing ordinary shares comprising the share capital of Sanofi and will acquire dividend rights as from 1 January 2023.The voting rights attached to the subscribed Shares will be exercised directly by the employees. Those taking up this offer will be required to hold the Shares or the corresponding FCPE units for a period of approximately five years, i.e. until 31 May 2028, except upon the occurrence of an early release event provided for under Article R. 3324-22 of the French Labour Code and authorized in the subscriber's country. Admission of the Shares to trading on the Euronext Paris market (ISIN Code: FR0000120578 ) on the same line as the existing shares will be requested as soon as possible after the completion of the capital increase.This press release does not constitute an offer to sell or a solicitation to buy Sanofi shares. The offer of Sanofi shares reserved for employees will only be made in countries where such an offer has been registered with or notified to the competent local authorities and/or following the approval of a prospectus by the competent local authorities, or in consideration of an exemption from the requirement to prepare a prospectus or to register or notify of the offer, where such procedure is required.More generally, the offer will only be made in countries where all required registration and/or notification procedures have been carried out, approvals obtained, and procedures for consulting or informing employee representatives followed.This press release is not intended for and should not be copied to or distributed in countries where such a prospectus has not been approved or such exemption is not available or where all necessary registration, notification, consultation and/or information procedures have not been completed or authorisations obtained. This relates in particular to Japan, Morocco, Tunisia and the Philippines, where to date formalities are still pending with the authorities but could also relate to other countries. This press release is prepared in accordance with the exemption from publication of a prospectus under Article 1 4i) and 5h) of the Prospectus Regulation (EU) 2017/1129. It constitutes the document required to meet the conditions for exemption from publication of a prospectus as defined by the Prospectus Regulation. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Media RelationsNicolas Obrist|+ 33 6 77 21 27 55 |nicolas.obrist@sanofi.comVictor Rouault|+ 33 6 70 93 71 40 |victor.rouault@sanofi.comEvan Berland | +1 215 432 0234 | evan.berland@sanofi.com Investor RelationsEva Schaefer-Jansen|+ 33 7 86 80 56 39 |eva.schaefer-jansen@sanofi.comArnaud Delepine|+ 33 6 73 69 36 93 | arnaud.delepine@sanofi.comCorentine Driancourt|+ 33 6 40 56 92 21 | corentine.driancourt@sanofi.comFelix Lauscher|+ 1908612 7239 | felix.lauscher@sanofi.comTarik Elgoutni| + 1 617 710 3587 | tarik.elgoutni@sanofi.comNathalie Pham|+ 33 7 85 93 30 17 | nathalie.pham@sanofi.com 1 Via employee Savings plan (PEG) and shares held directly by present employees Attachment Press release Source: West Corporation May 17, 2023: Banco Santander Sanofi: Information concerning the total number of voting rights and shares April 2023 Information concerning the total number of voting rights and shares, provided pursuant to article L. 233-8 II of the Code de commerce (the French Commercial Code) and article 223-16 of the Reglement general de lAutorite des Marches Financiers (Regulation of the French stock market authority) Sanofia French societe anonyme with a registered share capital of 2,521,494,572 Registered office : 46, avenue de la Grande Armee - 75017 Paris - FranceRegistered at the Paris Commercial and Companies Registry under number 395030844 Source: West Corporation Apr 19, 2023: Banco Santander Sanofi: Information concerning the total number of voting rights and shares - March 2023 Information concerning the total number of voting rights and shares, provided pursuant to article L. 233-8 II of the Code de commerce (the French Commercial Code) and article 223-16 of the Reglement general de lAutorite des Marches Financiers (Regulation of the French stock market authority) Sanofia French societe anonyme with a registered share capital of 2,521,494,572 Registered office : 46, avenue de la Grande Armee - 75017 Paris - FranceRegistered at the Paris Commercial and Companies Registry under number 395030844 Source: West Corporation Mar 14, 2023: Banco Santander Information concerning the total number of voting rights and shares February 2023 Information concerning the total number of voting rights and shares, provided pursuant to article L. 233-8 II of the Code de commerce (the French Commercial Code) and article 223-16 of the Reglement general de lAutorite des Marches Financiers (Regulation of the French stock market authority) Sanofia French societe anonyme with a registered share capital of 2,521,494,572 Registered office : 46, avenue de la Grande Armee - 75017 Paris - FranceRegistered at the Paris Commercial and Companies Registry under number 395030844 Source: West Corporation Feb 15, 2023: Banco Santander Sanofi: Information concerning the total number of voting rights and shares January 2023 Information concerning the total number of voting rights and shares, provided pursuant to article L. 233-8 II of the Code de commerce (the French Commercial Code) and article 223-16 of the Reglement general de lAutorite des Marches Financiers (Regulation of the French stock market authority) Sanofia French societe anonyme with a registered share capital of 2,521,494,572 Registered office : 46, avenue de la Grande Armee - 75017 Paris - FranceRegistered at the Paris Commercial and Companies Registry under number 395030844 Source: West Corporation Jan 17, 2023: Banco Santander Sanofi: Information concerning the total number of voting rights and shares December 2022 Information concerning the total number of voting rights and shares, provided pursuant to article L. 233-8 II of the Code de commerce (the French Commercial Code) and article 223-16 of the Reglement general de lAutorite des Marches Financiers (Regulation of the French stock market authority) Sanofia French societe anonyme with a registered share capital of 2,521,494,572 Registered office : 46, avenue de la Grande Armee - 75017 Paris - FranceRegistered at the Paris Commercial and Companies Registry under number 395030844 Source: West Corporation 2022 Dec 19, 2022: Banco Santander Sanofi: Information concerning the total number of voting rights and shares November 2022 Information concerning the total number of voting rights and shares, provided pursuant to article L. 233-8 II of the Code de commerce (the French Commercial Code) and article 223-16 of the Reglement general de lAutorite des Marches Financiers (Regulation of the French stock market authority) Sanofia French societe anonyme with a registered share capital of 2,534,952,234 Registered office : 46, avenue de la Grande Armee - 75017 Paris - FranceRegistered at the Paris Commercial and Companies Registry under number 395030844 Source: West Corporation Nov 14, 2022: Banco Santander Sanofi: Information concerning the total number of voting rights and shares October 2022 Information concerning the total number of voting rights and shares, provided pursuant to article L. 233-8 II of the Code de commerce (the French Commercial Code) and article 223-16 of the Reglement general de lAutorite des Marches Financiers (Regulation of the French stock market authority) Sanofia French societe anonyme with a registered share capital of 2,534,952,234 Registered office : 46, avenue de la Grande Armee - 75017 Paris - FranceRegistered at the Paris Commercial and Companies Registry under number 395030844 Source: West Corporation Oct 13, 2022: Banco Santander Sanofi: Information concerning the total number of voting rights and shares - September 2022 Information concerning the total number of voting rights and shares, provided pursuant to article L. 233-8 II of the Code de commerce (the French Commercial Code) and article 223-16 of the Reglement general de lAutorite des Marches Financiers (Regulation of the French stock market authority) Sanofia French societe anonyme with a registered share capital of 2,534,952,234 Registered office: 54, rue La Boetie - 75008 Paris - FranceRegistered at the Paris Commercial and Companies Registry under number 395030844 Source: West Corporation Sep 13, 2022: Banco Santander Sanofi: Information concerning the total number of voting rights and shares - August 2022 Information concerning the total number of voting rights and shares, provided pursuant to article L. 233-8 II of the Code de commerce (the French Commercial Code) and article 223-16 of the Reglement general de lAutorite des Marches Financiers (Regulation of the French stock market authority) Sanofia French societe anonyme with a registered share capital of 2,534,952,234 Registered office: 54, rue La Boetie - 75008 Paris - FranceRegistered at the Paris Commercial and Companies Registry under number 395030844 Source: West Corporation Aug 08, 2022: Banco Santander Sanofi: Information concerning the total number of voting rights and shares July 2022 Information concerning the total number of voting rights and shares, provided pursuant to article L. 233-8 II of the Code de commerce (the French Commercial Code) and article 223-16 of the Reglement general de lAutorite des Marches Financiers (Regulation of the French stock market authority) Sanofia French societe anonyme with a registered share capital of 2,534,952,234 Registered office: 54, rue La Boetie - 75008 Paris - FranceRegistered at the Paris Commercial and Companies Registry under number 395030844 Source: West Corporation Jul 20, 2022: Banco Santander Sanofi: Information concerning the total number of voting rights and shares June 2022 Information concerning the total number of voting rights and shares, provided pursuant to article L. 233-8 II of the Code de commerce (the French Commercial Code) and article 223-16 of the Reglement general de lAutorite des Marches Financiers (Regulation of the French stock market authority) Sanofia French societe anonyme with a registered share capital of 2,527,121,390 Registered office: 54, rue La Boetie - 75008 Paris - FranceRegistered at the Paris Commercial and Companies Registry under number 395030844 Source: West Corporation Jun 27, 2022: Banco Santander Sanofi: Information concerning the total number of voting rights and shares May 2022 Information concerning the total number of voting rights and shares, provided pursuant to article L. 233-8 II of the Code de commerce (the French Commercial Code) and article 223-16 of the Reglement general de lAutorite des Marches Financiers (Regulation of the French stock market authority) Sanofia French societe anonyme with a registered share capital of 2,527,121,390 Registered office: 54, rue La Boetie - 75008 Paris - FranceRegistered at the Paris Commercial and Companies Registry under number 395030844 Source: West Corporation Jun 07, 2022: Banco Santander Sanofi launches 2022 global Employee Stock Purchase Plan for 86.000 people Sanofi launches 2022 global Employee Stock Purchase Plan for 86.000 people Paris, June 7, 2022. Sanofi today launches Action 2022, its global employee share ownership plan, open to 86000 employees in 59 countries. The program, similar to programs carried out since 2013, clearly demonstrates the ongoing commitment of Sanofi and its Board of Directors to involve all employees, across all its territories, in the future development and results of the company. Paul HudsonChief Executive Officer of Sanofi I strongly believe along with the Board of Directors that a high employee shareholding contributes to develop a common spirit and unite our employees worldwide. This plan is a great opportunity for them to participate in the development of the company. Every year the record level of employee participation demonstrates how committed and supportive they are to Sanofi and its long-term strategy. Starting June 9th, the shares will be offered at a subscription price of 80.21, which is equal to a 20% discount off the average of the 20 opening prices of Sanofi shares from May 9 to June 3, 2022. In addition, for every five shares subscribed, employees will be able to receive one free share (up to a maximum of four free shares per employee). Each employee will be able to purchase up to 1,500 Sanofi shares within the legal limit of a maximum payment amount that does not exceed 25% of their gross annual salary, minus any voluntary deductions already made under employee savings schemes (Group Savings Plan and/or Group Retirement Savings Plan) during the year 2022. In 2021, the employee share ownership plan was open to over 90,000 employees in 73 countries with a growing overall uptake rate of 37.5% (vs 36.9% in 2020). More than 34,000 Sanofi employees chose to invest in the company. Today, nearly 75,000 current or former employees of the company are shareholders of Sanofi, and hold approximately 1.9%* of its capital.*via Employee Savings Plan (PEG) Detailed conditionsAn eligibility condition of three months employment by the closing date of the offer period will apply. Eligible staff will be able to subscribe shares from 9 June 2022 (inclusive) to 29 June 2022 (inclusive). The issue is expected to be completed and the delivery of the securities carried out by the end of July 2022.The maximum number of Sanofi shares that may be issued under this offer is 6,317,803 shares (corresponding to a maximum capital increase of 12,635,606 at nominal value, being 0.5% of share capital)The new shares, including the matching shares (the "Shares"), will be subscribed (or delivered) either directly or through the intermediary of employee mutual funds ("FCPE"), depending on the regulations and/or tax regime applicable in the various countries of residence of those eligible for the capital increase. The Shares will be fully fungible with the existing ordinary shares comprising the share capital of Sanofi and will acquire dividend rights as from 1 January 2022.The voting rights attached to the subscribed Shares will be exercised directly by the employees. Those taking up this offer will be required to hold the Shares or the corresponding FCPE units for a period of approximately five years, i.e. until 31 May 2027, except upon the occurrence of an early release event provided for under Article R. 3324-22 of the French Labour Code and authorized in the subscriber's country. Admission of the Shares to trading on the Euronext Paris market (ISIN Code: FR0000120578) on the same line as the existing shares will be requested as soon as possible after the completion of the capital increase.This press release does not constitute an offer to sell or a solicitation to buy Sanofi shares. The offer of Sanofi shares reserved for employees will only be made in countries where such an offer has been registered with or notified to the competent local authorities and/or following the approval of a prospectus by the competent local authorities, or in consideration of an exemption from the requirement to prepare a prospectus or to register or notify of the offer, where such procedure is required.More generally, the offer will only be made in countries where all required registration and/or notification procedures have been carried out, approvals obtained, and procedures for consulting or informing employee representatives followed.This press release is not intended for and should not be copied to or distributed in countries where such a prospectus has not been approved or such exemption is not available or where all necessary registration, notification, consultation and/or information procedures have not been completed or authorisations obtained. This relates in particular to Cameroon, Japan and the Philippines, where to date formalities are still pending with the authorities but could also relate to other countries. This press release is prepared in accordance with the exemption from publication of a prospectus under Article 1 4i) and 5h) of the Prospectus Regulation (EU) 2017/1129. It constitutes the document required to meet the conditions for exemption from publication of a prospectus as defined by the Prospectus Regulation. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Media RelationsNicolas Obrist|+ 33 6 77 21 27 55 |nicolas.obrist@sanofi.comVictor Rouault|+ 33 6 70 93 71 40 |victor.rouault@sanofi.com Investor RelationsEva Schaefer-Jansen|+ 33 7 86 80 56 39 |eva.schaefer-jansen@sanofi.comArnaud Delepine|+ 33 6 73 69 36 93 | arnaud.delepine@sanofi.comCorentine Driancourt|+ 33 6 40 56 92 21 | corentine.driancourt@sanofi.comFelix Lauscher|+ 1908612 7239 | felix.lauscher@sanofi.comPriya Nanduri| +1 617 764 6418 |priya.nanduri@sanofi.com Nathalie Pham|+ 33 7 85 93 30 17 | nathalie.pham@sanofi.com Attachment 22-06-07 - GPR ACTION 2022 ENG Source: West Corporation Jun 02, 2022: Banco Santander Sanofi: Information concerning the total number of voting rights and shares April 2022 Information concerning the total number of voting rights and shares, provided pursuant to article L. 233-8 II of the Code de commerce (the French Commercial Code) and article 223-16 of the Reglement general de lAutorite des Marches Financiers (Regulation of the French stock market authority) Sanofia French societe anonyme with a registered share capital of 2,527,121,390 Registered office: 54, rue La Boetie - 75008 Paris - FranceRegistered at the Paris Commercial and Companies Registry under number 395030844 Source: West Corporation Apr 26, 2022: Banco Santander Sanofi: Information concerning the total number of voting rights and shares March 2022 Information concerning the total number of voting rights and shares, provided pursuant to article L. 233-8 II of the Code de commerce (the French Commercial Code) and article 223-16 of the Reglement general de lAutorite des Marches Financiers (Regulation of the French stock market authority) Sanofia French societe anonyme with a registered share capital of 2,527,121,390 Registered office: 54, rue La Boetie - 75008 Paris - FranceRegistered at the Paris Commercial and Companies Registry under number 395030844 Source: West Corporation Mar 26, 2022: Banco Santander Sanofi: Information concerning the total number of voting rights and shares February 2022 Information concerning the total number of voting rights and shares, provided pursuant to article L. 233-8 II of the Code de commerce (the French Commercial Code) and article 223-16 of the Reglement general de lAutorite des Marches Financiers (Regulation of the French stock market authority) Sanofia French societe anonyme with a registered share capital of 2,527,121,390 Registered office: 54, rue La Boetie - 75008 Paris - FranceRegistered at the Paris Commercial and Companies Registry under number 395030844 Source: West Corporation Feb 22, 2022: Banco Santander Sanofi: Information concerning the total number of voting rights and shares - January 2022 Information concerning the total number of voting rights and shares, provided pursuant to article L. 233-8 II of the Code de commerce (the French Commercial Code) and article 223-16 of the Reglement general de lAutorite des Marches Financiers (Regulation of the French stock market authority) Sanofia French societe anonyme with a registered share capital of 2,527,121,390 Registered office: 54, rue La Boetie - 75008 Paris - FranceRegistered at the Paris Commercial and Companies Registry under number 395030844 Source: West Corporation Jan 17, 2022: Banco Santander Sanofi: Information concerning the total number of voting rights and shares December 2021 Information concerning the total number of voting rights and shares, provided pursuant to article L. 233-8 II of the Code de commerce (the French Commercial Code) and article 223-16 of the Reglement general de lAutorite des Marches Financiers (Regulation of the French stock market authority) Sanofia French societe anonyme with a registered share capital of 2,526,866,030 Registered office: 54, rue La Boetie - 75008 Paris - FranceRegistered at the Paris Commercial and Companies Registry under number 395030844 Source: West Corporation 2021 Dec 21, 2021: Banco Santander Sanofi: Information concerning the total number of voting rights and shares - NOVEMBER 2021 Information concerning the total number of voting rights and shares, provided pursuant to article L. 233-8 II of the Code de commerce (the French Commercial Code) and article 223-16 of the Reglement general de lAutorite des Marches Financiers (Regulation of the French stock market authority) Sanofia French societe anonyme with a registered share capital of 2,526,866,030 Registered office: 54, rue La Boetie - 75008 Paris - FranceRegistered at the Paris Commercial and Companies Registry under number 395030844 Source: West Corporation Oct 27, 2021: Banco Santander Sanofi: Information concerning the total number of voting rights and shares - September 2021 Information concerning the total number of voting rights and shares, provided pursuant to article L. 233-8 II of the Code de commerce (the French Commercial Code) and article 223-16 of the Reglement general de lAutorite des Marches Financiers (Regulation of the French stock market authority) Sanofia French societe anonyme with a registered share capital of 2,526,866,030 Registered office: 54, rue La Boetie - 75008 Paris - FranceRegistered at the Paris Commercial and Companies Registry under number 395030844 Source: West Corporation Oct 01, 2021: Banco Santander Sanofi: Information concerning the total number of voting rights and shares - August 2021 Information concerning the total number of voting rights and shares, provided pursuant to article L. 233-8 II of the Code de commerce (the French Commercial Code) and article 223-16 of the Reglement general de lAutorite des Marches Financiers (Regulation of the French stock market authority) Sanofia French societe anonyme with a registered share capital of 2,526,866,030 Registered office: 54, rue La Boetie - 75008 Paris - FranceRegistered at the Paris Commercial and Companies Registry under number 395030844 Source: West Corporation Aug 25, 2021: Banco Santander Sanofi: Information concerning the total number of voting rights and shares - July 2021 Information concerning the total number of voting rights and shares, provided pursuant to article L. 233-8 II of the Code de commerce (the French Commercial Code) and article 223-16 of the Reglement general de lAutorite des Marches Financiers (Regulation of the French stock market authority) Sanofia French societe anonyme with a registered share capital of 2,517,943,476 Registered office: 54, rue La Boetie - 75008 Paris - FranceRegistered at the Paris Commercial and Companies Registry under number 395030844 Source: West Corporation Jul 22, 2021: Banco Santander Sanofi: Information concerning the total number of voting rights and shares - June 2021 Information concerning the total number of voting rights and shares, provided pursuant to article L. 233-8 II of the Code de commerce (the French Commercial Code) and article 223-16 of the Reglement general de lAutorite des Marches Financiers (Regulation of the French stock market authority) Sanofia French societe anonyme with a registered share capital of 2,517,943,476 Registered office: 54, rue La Boetie - 75008 Paris - FranceRegistered at the Paris Commercial and Companies Registry under number 395030844 Source: West Corporation Jun 30, 2021: Banco Santander Sanofi: Information concerning the total number of voting rights and shares - May 2021 Information concerning the total number of voting rights and shares, provided pursuant to article L. 233-8 II of the Code de commerce (the French Commercial Code) and article 223-16 of the Reglement general de lAutorite des Marches Financiers (Regulation of the French stock market authority) Sanofia French societe anonyme with a registered share capital of 2,517,943,476 Registered office: 54, rue La Boetie - 75008 Paris - FranceRegistered at the Paris Commercial and Companies Registry under number 395030844 Source: West Corporation May 31, 2021: Banco Santander Sanofi: Information concerning the total number of voting rights and shares - April 2021 Information concerning the total number of voting rights and shares, provided pursuant to article L. 233-8 II of the Code de commerce (the French Commercial Code) and article 223-16 of the Reglement general de lAutorite des Marches Financiers (Regulation of the French stock market authority) Sanofi a French societe anonyme with a registered share capital of 2,517,943,476 Registered office: 54, rue La Boetie - 75008 Paris - France Registered at the Paris Commercial and Companies Registry under number 395030844 * Pursuant to article 223-11 of the Reglement general de lAutorite des Marches Financiers. This information is also available on the internet website of sanofi under Regulated Information in France:https://www.sanofi.com/en/investors/sanofi-share-and-adrs/share-overview/shares-and-voting-rights/ Attachment EN_number_of_shares_and_voting_rights_April_2021 Source: West Corporation 2020 Dec 29, 2020: Banco Santander Sanofi: Information concerning the total number of voting rights and shares - November 2020 Information concerning the total number of voting rights and shares, provided pursuant to article L. 233-8 II of the Code de commerce Source: West Corporation Dec 10, 2020: Banco Santander announces Right Issue Banco Santander has announced a 1 for 1 rights issue effective Friday, December 11. To subscribe to new shares the price has been fixed at 50.0c. Nov 30, 2020: Banco Santander Sanofi: Disclosure of trading in own shares Disclosure of trading in own shares from November 23, 2020 to November 27, 2020 Attachment 2020_11_27_Reporting_action_SANOFI_EN Source: West Corporation Nov 23, 2020: Banco Santander Sanofi: Disclosure of trading in own shares Disclosure of trading in own shares from November 17, 2020 to November 20, 2020 Attachment 2020_11_20_Reporting_action_SANOFI_EN Source: West Corporation Sep 11, 2020: Banco Santander Sanofi : Information concerning the total number of voting rights and shares - July 2020 Information concerning the total number of voting rights and shares, provided pursuant to article L. 233-8 II of the Code de commerce (the French Commercial Code) and article 223-16 of the Reglement general de l'Autorite des Marches Financiers (Regulation of the French stock market authority) Sanofia French societe anonyme with a registered share capital of 2,517,873,886 EURRegistered office : 54, rue La Boetie - 75008 Paris - FranceRegistered at the Paris Commercial and Companies Registry under number 395 030 844 Source: West Corporation Jul 21, 2020: Banco Santander Sanofi: Information concerning the total number of voting rights and shares - June 2020 Information concerning the total number of voting rights and shares, provided pursuant to article L. 233-8 II of the Code de commerce (the French Commercial Code) and article 223-16 of the Reglement general de l'Autorite des Marches Financiers (Regulation of the French stock market authority) Sanofia French societe anonyme with a registered share capital of 2,507,692,222 EURRegistered office : 54, rue La Boetie - 75008 Paris - FranceRegistered at the Paris Commercial and Companies Registry under number 395 030 844 Source: West Corporation Jun 19, 2020: Banco Santander Sanofi: Information concerning the total number of voting rights and shares - May 2020 Information concerning the total number of voting rights and shares, provided pursuant to article L. 233-8 II of the Code de commerce (the French Commercial Code) and article 223-16 of the Reglement general de l'Autorite des Marches Financiers (Regulation of the French stock market authority) Sanofia French societe anonyme with a registered share capital of 2,507,692,222 EURRegistered office : 54, rue La Boetie - 75008 Paris - FranceRegistered at the Paris Commercial and Companies Registry under number 395 030 844 Source: West Corporation Jun 03, 2020: Banco Santander Sanofi to launch "Action 2020", a worldwide employee stock purchase plan Sanofi to launch "Action 2020", a worldwide employee stock purchase plan A plan taking place in almost 75 countriesSubscription per five shares entitle the employee to one matching share1 PARIS - June 3, 2020 - Sanofi announces the launch of "Action 2020" on June 8, 2020, a worldwide stock purchase plan reserved for its employees, which should take place in almost 75 countries. Sanofi's strategy aims at providing long-term growth and value for its stakeholders while turning innovation into transformative medicines for patients. By doing such a capital increase, Sanofi intends to better associate its employees who are key contributors in this value creation, to the future development and results of the company. On February 5, 2020 the Board of Directors authorized an issuance of ordinary shares of Sanofi for the benefit of employees participating in the Group Savings Plan. The subscription price is EUR70.67. It is equal to 80 % of the average of the opening price of the Sanofi share on Euronext Paris over the 20 stock exchange trading sessions preceding June 2, 2020. Any subscription per five shares as part of such issuance shall entitle the employee to one matching share. Subscriptions equal to or higher than 20 shares shall give right to 4 matching shares as an employer contribution. Employees may choose to subscribe a maximum of 1,500 shares within the limit of a maximum subscription amount which does not exceed 25% of their gross annual remuneration. An eligibility condition of three months of seniority as at the closing date of the subscription period will be applied. The subscription period will run from June 8, 2020 (inclusive) until June 26, 2020 (inclusive). Source: West Corporation May 25, 2020: Banco Santander Sanofi: information concerning the total number of voting rights and shares, April 2020 Information concerning the total number of voting rights and shares, provided pursuant to article L. 233-8 II of the Code de commerce (the French Commercial Code) and article 223-16 of the Reglement general de l'Autorite des Marches Financiers (Regulation of the French stock market authority) Sanofia French societe anonyme with a registered share capital of 2,507,692,222 EURRegistered office : 54, rue La Boetie - 75008 Paris - FranceRegistered at the Paris Commercial and Companies Registry under number 395 030 844 Source: West Corporation Dividends 2024 Feb 24, 2024: Banco Santander announces dividend Banco Santander today announced an interim dividend of 10.0c per share. The ex-dividend date is Monday, April 29, 2024 and it is payable on Thursday, May 02. 2023 Sep 28, 2023: Banco Santander announces dividend Banco Santander today announced an interim dividend of 8.10c per share. The ex-dividend date is Tuesday, October 31, 2023 and the record date is Wednesday, November 01, 2023 and it is payable on Thursday, November 02. 2022 Sep 28, 2022: Banco Santander announces dividend Banco Santander today announced an interim dividend of 5.83c per share. The ex-dividend date is Monday, October 31, 2022 and the record date is Tuesday, November 01, 2022 and it is payable on Wednesday, November 02. Apr 28, 2022: Banco Santander announces dividend Banco Santander today announced a final dividend of 5.15c per share. The ex-dividend date is Thursday, April 28, 2022 and it is payable on Monday, May 02. 2021 Oct 29, 2021: Banco Santander announces dividend Banco Santander today announced an interim dividend of 4.85c per share. The ex-dividend date is Friday, October 29, 2021 and it is payable on Tuesday, November 02. Acquisitions 2023 Jul 28, 2023: Banco Santander Press Release: Sanofi to acquire Qunol, a fast-growing U.S. brand in the healthy aging segment Sanofi to acquire Qunol, a fast-growing U.S. brand in the healthy aging segment Transaction brings Qunol, a trusted, profitable double-digit growth and market-leading brand in health & wellness to Sanofis CHC U.S. portfolioAddition of Qunols CoQ10 and Turmeric products strengthens Sanofis CHC Vitamin, Mineral and Supplements category, one of the largest and fastest-growing consumer health categories in the U.S. Paris, July 28, 2023. Sanofi announces today it has entered into a definitive agreement to acquire ownership of Qunol, a U.S.-based, market-leading brand in health & wellness. This transaction will strengthen Sanofis Consumer Healthcares (CHC) Vitamin, Mineral and Supplements (VMS) category, one of the largest and fastest-growing consumer health categories in the U.S., focusing on the active healthy aging segment. With Qunols CoQ10 in heart health and Turmeric in joint health, CHC at Sanofi adds a trusted, profitable double-digit growth brand to its U.S. portfolio, focused on chronic conditions with growing consumer demand. With this acquisition, Sanofi continues to pursue growth opportunities and value creation for its consumer healthcare business. Julie Van OngevalleExecutive Vice President, Consumer Healthcare, SanofiThe acquisition of Qunol further strengthens our portfolio in the wellness category. It taps into the growing healthy aging segment and fills one of our white spaces in the US, unlocking an opportunity for us to build on our U.S. presence and accelerate our growth. VMS now functions as long-term support for overall health and wellness where proactive preventive health has become the new norm post-pandemic. We are excited to welcome Qunol and, with this addition to our consumer healthcare portfolio, reinforce our commitment to bring more health into the hands of people. Qunol CoQ10 and Turmeric products are both backed by science literature and strong market positioning in their segments. Qunols high product quality and efficacy have resulted in strong brand equity among consumers and customers, as well as above category consumer loyalty. The Qunol brand will benefit from Sanofis CHC resources to expand into other chronic conditions and develop its footprint outside the U.S. Peter BoutrosCEO, Quten Research Institute, LLCQunol is looking forward to joining Sanofis consumer healthcare team and developing synergies that will further drive brand awareness for our products with our consumers and customers. With Sanofi, we have the opportunity to further grow in the U.S. and beyond, tapping into Sanofi Consumer Healthcares commercial breadth and strength. Transaction terms Sanofi entered into a definitive agreement to acquire ownership of Qunol, subject to customary closing conditions, including applicable regulatory approvals. The acquisition is expected to close Q3 2023. About QunolFounded in 2006 with the goal of delivering efficacious, science-backed health solutions, Qunol is a market leader in the VMS industry and at the forefront of the fast-growing healthy aging sector. The brand's CoQ10 and Turmeric products are differentiated solutions that combine high-quality ingredients with unique absorption technology to deliver powerful support for heart health and joint health respectively. Qunol's products enjoy multiple #1 market positions across leading Club, Mass and Ecommerce retailers in North America. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Media RelationsSandrine Guendoul | + 33 6 25 09 14 25 | sandrine.guendoul@sanofi.comEvan Berland | +1 215 432 0234 | evan.berland@sanofi.comVictor Rouault | + 33 6 70 93 71 40 | victor.rouault@sanofi.com Investor RelationsEva Schaefer-Jansen | + 33 7 86 80 56 39 | eva.schaefer-jansen@sanofi.comArnaud Delepine | + 33 6 73 69 36 93 | arnaud.delepine@sanofi.comCorentine Driancourt | + 33 6 40 56 92 21 | corentine.driancourt@sanofi.comFelix Lauscher | + 1 908 612 7239 | felix.lauscher@sanofi.comTarik Elgoutni| + 1 617 710 3587 | tarik.elgoutni@sanofi.comNathalie Pham | + 33 7 85 93 30 17 | nathalie.pham@sanofi.com Sanofi Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements are generally identified by the words expects, anticipates, believes, intends, estimates, plans and similar expressions. Although Sanofis management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful, risks related to Sanofis ability to complete the acquisition on the proposed terms or on the proposed timeline, including the receipt of required regulatory approvals, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact that pandemics or other global crises may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under Risk Factors and Cautionary Statement Regarding Forward-Looking Statements in Sanofis annual report on Form 20-F for the year ended December 31, 2022. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. Attachment Press_Release Source: West Corporation Apr 27, 2023: Banco Santander Press Release: Sanofi completes acquisition of Provention Bio, Inc. Sanofi completes acquisition of Provention Bio, Inc. Paris, April 27 2023. Sanofi announced today the completion of its acquisition of Provention Bio, Inc. (Provention Bio). The acquisition adds TZIELD (teplizumab-mzwv), an innovative, fully owned, first-in-class therapy in type 1 diabetes to Sanofis core asset portfolio in General Medicines and further drives its strategic shift toward products with a differentiated profile. Olivier CharmeilExecutive Vice President, General Medicines, Sanofi We are excited to finalize our acquisition of Provention Bio, Inc. This strategic fit for Sanofi lies at the intersection of our growth in immune-mediated diseases and disease-modifying therapies in areas of high unmet need. On November 17, 2022 the U.S. Food and Drug Administration approved TZIELD injection to delay the onset of stage 3 type 1 diabetes in adults and pediatric patients 8 years and older who currently have stage 2 type 1 diabetes. The tender offer for all of the outstanding shares of Provention Bio common stock expired at one minute after 11:59 P.M., Eastern Time, on Wednesday, April 26, 2023. The minimum tender condition and all of the other conditions to the offer have been satisfied and on April 27, 2023, Sanofi accepted for payment and will promptly pay for all shares validly tendered and not validly withdrawn. Following its acceptance of the tendered shares, Sanofi completed its acquisition of Provention Bio through the merger of a wholly owned subsidiary of Sanofi with and into Provention Bio, pursuant to Section 251(h) of the General Corporation Law of the State of Delaware, with Provention Bio continuing as the surviving corporation and becoming an indirect, wholly owned subsidiary of Sanofi. In connection with the merger, all Provention Bio shares not validly tendered in the tender offer have been converted into the right to receive the same $25.00 per share in cash, without interest thereon and net of any applicable withholding taxes, that would have been paid had such shares been validly tendered in the tender offer. As of April 27, 2023, Provention Bio common stock will cease to be traded on the NASDAQ Global Select Stock Market. PJT Partners acted as exclusive financial advisor to Sanofi and Weil, Gotshal & Manges LLP acted as its legal counsel. BofA Securities, Inc. and Centerview Partners LLC acted as financial advisors to Provention Bio and Ropes & Gray LLP acted as its legal counsel. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Media RelationsSandrine Guendoul|+ 33 6 25 09 14 25 |sandrine.guendoul@sanofi.comEvan Berland | +1 215 432 0234 | evan.berland@sanofi.comNicolas Obrist|+ 33 6 77 21 27 55 |nicolas.obrist@sanofi.comVictor Rouault|+ 33 6 70 93 71 40 |victor.rouault@sanofi.com Investor RelationsEva Schaefer-Jansen|+ 33 7 86 80 56 39 |eva.schaefer-jansen@sanofi.comArnaud Delepine|+ 33 6 73 69 36 93 | arnaud.delepine@sanofi.comCorentine Driancourt|+ 33 6 40 56 92 21 | corentine.driancourt@sanofi.comFelix Lauscher|+ 1908612 7239 | felix.lauscher@sanofi.comTarik Elgoutni| + 1 617 710 3587 | tarik.elgoutni@sanofi.comNathalie Pham|+ 33 7 85 93 30 17 | nathalie.pham@sanofi.com Sanofi Forward-Looking StatementsThis press release contains forward-looking statements. Forward-looking statements are statements that are not historical facts. These statements may include projections and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product, and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words expects, anticipates, believes, will be, intends, estimates, plans and similar expressions. Although Sanofis management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forwardlooking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful and other risks associated with executing business combination transactions, such as the risk that the businesses will not be integrated successfully, that such integration may be more difficult, time-consuming or costly than expected or that the expected benefits of the acquisition will not be realized, as well as other risks related to Sanofis business, including the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact that pandemics or other global crises may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under Risk Factors and Cautionary Statement Regarding Forward-Looking Statements in Sanofis annual report on Form 20-F for the year ended December 31, 2022. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. Attachment Source: West Corporation Apr 26, 2023: Banco Santander Press Release: Hart-Scott-Rodino waiting period expires for Sanofis acquisition of Provention Bio, Inc. Hart-Scott-Rodino waiting period expires for Sanofis acquisition of Provention Bio, Inc. Paris, France April 26, 2023 Sanofi announced today that the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended (the HSR Act), applicable to Sanofis proposed acquisition of Provention Bio, Inc. (Provention Bio, NASDAQ: PRVB) has expired. On March 24, 2023, Sanofi commenced a cash tender offer (the Offer) to purchase all outstanding shares of common stock of Provention Bio (the Shares), for $25.00 per Share, to the seller thereof in cash, without interest and subject to any withholding taxes required by applicable law. As a result of the expiration of the waiting period under the HSR Act, the condition to the Offer relating to the expiration or termination of the waiting period under the HSR Act has been satisfied. The consummation of the Offer remains subject to various conditions, including the tender of a number of Shares which, together with the Shares owned by Sanofi and its wholly owned subsidiaries (including Zest Acquisition Sub, Inc.), represent at least a majority of the Shares outstanding immediately prior to the expiration of the Offer and other customary conditions described in the Offer to Purchase filed by Sanofi with the U.S. Securities and Exchange Commission (the SEC) on March 24, 2023, as amended. The Offer is scheduled to expire at one minute after 11:59 P.M., Eastern Time, on April 26, 2023. The Offer may be extended further in accordance with the merger agreement, dated March 12, 2023, by and among Sanofi, Zest Acquisition Sub, Inc. and Provention Bio, and the applicable rules and regulations of the SEC. All other terms and conditions of the Offer remain unchanged. Innisfree M&A Incorporated is acting as information agent for the tender offer. Requests for documents and questions regarding the tender offer may be directed to Innisfree M&A Incorporated by telephone, toll-free at (877) 800-5195 for shareholders, or collect at (212) 750-5833 for Banks and Brokers. About Sanofi We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Media Relations Sandrine Guendoul|+ 33 6 25 09 14 25 |sandrine.guendoul@sanofi.comEvan Berland |+ 1 215 432 0234 |evan.berland@sanofi.comNicolas Obrist|+ 33 6 77 21 27 55 |nicolas.obrist@sanofi.com Investor Relations Eva Schaefer-Jansen|+ 33 7 86 80 56 39 |eva.schaefer-jansen@sanofi.comArnaud Delepine|+ 33 6 73 69 36 93 | arnaud.delepine@sanofi.comCorentine Driancourt|+ 33 6 40 56 92 21 | corentine.driancourt@sanofi.comFelix Lauscher|+ 1908612 7239 | felix.lauscher@sanofi.comTarik Elgoutni | + 1 617 710 3587 | tarik.elgoutni@sanofi.comNathalie Pham|+ 33 7 85 93 30 17 | nathalie.pham@sanofi.com Sanofi Forward-Looking Statements This press release contains forward-looking statements. Forward-looking statements are statements that are not historical facts. These statements may include projections and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product, and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words expects, anticipates, believes, will be, intends, estimates, plans and similar expressions. Although Sanofis management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful and risks related to Sanofis ability to complete the acquisition on the proposed terms or on the proposed timeline, including the receipt of required regulatory approvals, the possibility that competing offers will be made, other risks associated with executing business combination transactions, such as the risk that the businesses will not be integrated successfully, that such integration may be more difficult, time-consuming or costly than expected or that the expected benefits of the acquisition will not be realized, as well as other risks related to Sanofis business, including the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact that pandemics or other global crises may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under Risk Factors and Cautionary Statement Regarding Forward-Looking Statements in Sanofis annual report on Form 20-F for the year ended December 31, 2022. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. Additional Information for US Shareholders and Where to Find It This communication is for informational purposes only and is neither an offer to purchase nor a solicitation of an offer to sell shares of Provention Bio, Inc. Sanofi and its acquisition subsidiary have filed with the U.S. Securities and Exchange Commission (the SEC) a tender offer statement on Schedule TO, and Provention Bio, Inc. has filed a Solicitation/Recommendation Statement on Schedule 14D-9, all with respect to the Offer (as defined in those documents). HOLDERS OF SHARES OF PROVENTION BIO, INC. ARE URGED TO READ THE RELEVANT TENDER OFFER MATERIALS (INCLUDING THE OFFER TO PURCHASE, THE RELATED LETTER OF TRANSMITTAL AND THE OTHER TENDER OFFER DOCUMENTS) AND THE SOLICIATION/RECOMMENDATION STATEMENT BECAUSE THEY CONTAIN IMPORTANT INFORMATION THAT PROVENTION BIO, INC. STOCKHOLDERS SHOULD CONSIDER BEFORE MAKING ANY DECISION REGARDING TENDERING SHARES. The Offer to Purchase, the related Letter of Transmittal and certain other tender offer documents, as well as the Solicitation/Recommendation Statement, are available to holders of shares of Provention Bio, Inc. at no expense to them. The tender offer materials and the Solicitation/Recommendation Statement are available for free at the SECs website at www.sec.gov. Additional copies may be obtained for free by contacting Sanofis Investor Relations Department at ir@sanofi.com or on Sanofis website at https://en.sanofi.com/investors or by contacting Kristen Kelleher, Investor Relations, at investorrelations@proventionbio.com, or on Provention Bio, Inc.s website, www.proventionbio.com. In addition to the Offer to Purchase, the related Letter of Transmittal and certain other tender offer documents, as well as the Solicitation/Recommendation Statement, Sanofi files annual and special reports and other information with the SEC and Provention Bio., Inc. files annual, quarterly and special reports and other information with the SEC. You may read and copy any reports or other information filed by Sanofi and Provention Bio., Inc. at the SEC public reference room at 100 F. Street, N.E., Washington D.C. 20549. Please call the Commission at 1-800-SEC-0330 for further information on the public reference room. Sanofis and Provention Bio., Inc.s filings with the SEC are also available to the public from commercial document-retrieval services and at the website maintained by the SEC at www.sec.gov Attachment Source: West Corporation Apr 10, 2023: Banco Santander Press Release: Sanofi announces withdrawal and refiling of Premerger Notification and Report Form under the HSR Act and extension of tender offer to acquire Provention Bio, Inc. Sanofi announces withdrawal and refiling of Premerger Notification and Report Form under the HSR Act and extension of tender offer to acquire Provention Bio, Inc. Paris, France April 10, 2023 Sanofi announced today that it has withdrawn and refiled its Premerger Notification and Report Form under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended (the HSR Act), in connection with Sanofis pending acquisition of Provention Bio, Inc. As previously announced on March 24, 2023, Sanofi commenced a cash tender offer to purchase all outstanding shares of common stock of Provention Bio, Inc. (the Shares), for $25.00 per Share, to the seller thereof in cash, without interest and subject to any withholding taxes required by applicable law. Sanofi has elected to withdraw and refile its Premerger Notification and Report Form, which was initially filed on March 24, 2023, to provide the Federal Trade Commission (the FTC) with additional time for review. Following such refiling, the waiting period under the HSR Act will expire at 11:59 P.M., Eastern Time, on April 25, 2023. The acquisition is expected to close in the second quarter of 2023. Consummation of the tender offer remains subject to, among other conditions, the expiration or termination of the applicable waiting period under the HSR Act. As a result, Sanofi is extending the tender offer, which was previously scheduled to expire at one minute after 11:59 P.M., Eastern Time, on April 20, 2023, until one minute after 11:59 P.M., Eastern Time, on April 26, 2023. The tender offer may be extended further in accordance with the merger agreement and the applicable rules and regulations of the U.S. Securities and Exchange Commission (the SEC). All other terms and conditions of the tender offer will remain unchanged during the extended period. Innisfree M&A Incorporated is acting as information agent for the tender offer. Requests for documents and questions regarding the tender offer may be directed to Innisfree M&A Incorporated by telephone, toll-free at (877) 800-5195 for shareholders, or collect at (212) 750-5833 for Banks and Brokers. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Media RelationsSandrine Guendoul|+ 33 6 25 09 14 25 |sandrine.guendoul@sanofi.comEvan Berland |+ 1 215 432 0234 |evan.berland@sanofi.comNicolas Obrist|+ 33 6 77 21 27 55 |nicolas.obrist@sanofi.com Investor RelationsEva Schaefer-Jansen|+ 33 7 86 80 56 39 |eva.schaefer-jansen@sanofi.comArnaud Delepine|+ 33 6 73 69 36 93 | arnaud.delepine@sanofi.comCorentine Driancourt|+ 33 6 40 56 92 21 | corentine.driancourt@sanofi.comFelix Lauscher|+ 1908612 7239 | felix.lauscher@sanofi.comTarik Elgoutni | + 1 617 710 3587 | tarik.elgoutni@sanofi.comNathalie Pham|+ 33 7 85 93 30 17 | nathalie.pham@sanofi.com Sanofi Forward-Looking StatementsThis press release contains forward-looking statements. Forward-looking statements are statements that are not historical facts. These statements may include projections and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product, and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words expects, anticipates, believes, will be, intends, estimates, plans and similar expressions. Although Sanofis management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful and risks related to Sanofis ability to complete the acquisition on the proposed terms or on the proposed timeline, including the receipt of required regulatory approvals, the possibility that competing offers will be made, other risks associated with executing business combination transactions, such as the risk that the businesses will not be integrated successfully, that such integration may be more difficult, time-consuming or costly than expected or that the expected benefits of the acquisition will not be realized, as well as other risks related Sanofis business, including the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under Risk Factors and Cautionary Statement Regarding Forward-Looking Statements in Sanofis annual report on Form 20-F for the year ended December 31, 2022. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. Additional Information for US Shareholders and Where to Find It This communication is for informational purposes only and is neither an offer to purchase nor a solicitation of an offer to sell shares of Provention Bio, Inc. Sanofi and its acquisition subsidiary have filed with the U.S. Securities and Exchange Commission (the SEC) a tender offer statement on Schedule TO, and Provention Bio, Inc. has filed a Solicitation/Recommendation Statement on Schedule 14D-9, all with respect to the Offer (as defined in those documents). HOLDERS OF SHARES OF PROVENTION BIO, INC. ARE URGED TO READ THE RELEVANT TENDER OFFER MATERIALS (INCLUDING THE OFFER TO PURCHASE, THE RELATED LETTER OF TRANSMITTAL AND THE OTHER TENDER OFFER DOCUMENTS) AND THE SOLICIATION/RECOMMENDATION STATEMENT BECAUSE THEY CONTAIN IMPORTANT INFORMATION THAT PROVENTION BIO, INC. STOCKHOLDERS SHOULD CONSIDER BEFORE MAKING ANY DECISION REGARDING TENDERING SHARES. The Offer to Purchase, the related Letter of Transmittal and certain other tender offer documents, as well as the Solicitation/Recommendation Statement, are available to holders of shares of Provention Bio, Inc. at no expense to them. The tender offer materials and the Solicitation/Recommendation Statement are available for free at the SECs website at www.sec.gov. Additional copies may be obtained for free by contacting Sanofis Investor Relations Department at ir@sanofi.com or on Sanofis website at https://en.sanofi.com/investors or by contacting Kristen Kelleher, Investor Relations, at investorrelations@proventionbio.com, or on Provention Bio, Inc.s website, www.proventionbio.com. In addition to the Offer to Purchase, the related Letter of Transmittal and certain other tender offer documents, as well as the Solicitation/Recommendation Statement, Sanofi files annual and special reports and other information with the SEC and Provention Bio., Inc. files annual, quarterly and special reports and other information with the SEC. You may read and copy any reports or other information filed by Sanofi and Provention Bio., Inc. at the SEC public reference room at 100 F. Street, N.E., Washington D.C. 20549. Please call the Commission at 1-800-SEC-0330 for further information on the public reference room. Sanofis and Provention Bio., Inc.s filings with the SEC are also available to the public from commercial document-retrieval services and at the website maintained by the SEC at www.sec.gov Attachment Source: West Corporation Mar 13, 2023: Banco Santander Press Release: Sanofi to acquire Provention Bio, adding to portfolio TZIELD, the first disease-modifying treatment for the delay of Stage 3 type 1 diabetes (T1D) Sanofi to acquire Provention Bio, adding to portfolio TZIELD, the first disease-modifying treatment for the delay of Stage 3 type 1 diabetes (T1D) Paris and Red Bank, N.J. March 13, 2023 Sanofi and Provention Bio, Inc., a U.S.-based, publicly traded biopharmaceutical company focused on intercepting and preventing immune-mediated diseases including type 1 diabetes (T1D), have entered into an agreement under which Sanofi has agreed to acquire Provention Bio, Inc., for $25.00 per share in cash, representing an equity value of approximately $2.9 billion. The transaction adds an innovative, fully owned, first-in-class therapy in type 1 diabetes to Sanofis core asset portfolio in General Medicines and further drives its strategic shift toward products with a differentiated profile. TZIELD (teplizumab-mzwv) was approved in the U.S. last year as the first and only therapy to delay the onset of Stage 3 type 1 diabetes (T1D) in adults and pediatric patients aged 8 years and older with Stage 2 T1D. The acquisition is a strategic fit for Sanofi at the intersection of the companys growth in immune-mediated diseases and disease-modifying therapies in areas of high unmet need, and its expertise in diabetes. Sanofi will continue to utilize its capabilities in diabetes to maximize TZIELDs potential as a transformative therapy globally and in the U.S., aiming to delay the onset of Stage 3 type 1 diabetes for some of the approximately 65,000 people diagnosed every year1. The purchase builds on an existing co-promotion agreement with Provention Bio that is already delivering TZIELD to patients in need of this immune-mediated therapy. Olivier CharmeilExecutive Vice President, General Medicines, Sanofi The acquisition of Provention Bio builds on Sanofis mission to deliver best- and first-in-class medicines and resonates with our purpose of chasing the miracles of science for the benefit of people. By coupling Provention Bios transformative innovation with Sanofis expertise, we aim to bring life-changing benefits to people at risk of developing Stage 3 type 1 diabetes. Any additional indications, approvals and pipeline assets only serve to further our excitement. Given our existing partnership and complementary work in the diabetes and immunology spaces, we foresee a seamless integration and execution. TZIELD: First and only treatment indicated to delay onset of Stage 3 T1D TZIELD is a CD3-directed antibody indicated to delay the onset of Stage 3 T1D in adults and pediatric patients aged 8 years and older with Stage 2 T1D. Stage 3 T1D is associated with significant health risks, including diabetic ketoacidosis, which can be life threatening, and patients who progress to Stage 3 T1D eventually require insulin injections for life. TZIELD is also in late-stage clinical development for the treatment of pediatric and adolescent patients that are newly diagnosed with clinical T1D (Stage 3). A Phase 3 trial, PROTECT, is currently underway and top line results are expected in the second half of 2023. Additional opportunities for TZIELD include re-dosing and formulations as well as new therapeutic indications. Ashleigh PalmerChief Executive Officer and Co-Founder, Provention Bio, Inc.Sanofi and Provention Bio share a common vision of bringing new therapies to patients with autoimmune diseases. Under our co-promotion agreement, our companies have made significant progress educating healthcare providers and increasing patient access during the initial U.S. commercial launch of TZIELD. Sanofis global expertise and commitment to immunology makes them an ideal acquiror and positions our innovative therapy to reach more patients as quickly as possible. Provention Bio also brings certain pipeline assets in early development in immune-mediated diseases. Transaction Terms Under the terms of the merger agreement, Sanofi will commence a cash tender offer to acquire all outstanding shares of Provention Bio, Inc. for $25.00 per share in cash, reflecting a total equity value of approximately $2.9 billion. The consummation of the tender offer is subject to customary closing conditions, including the tender of a number of shares of Provention Bio, Inc. common stock, that together with shares already owned by Sanofi or its affiliates, represents at least a majority of the outstanding shares of Provention Bio, Inc. common stock, the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, and other customary conditions. If the tender offer is successfully completed, then following the successful completion of the tender offer, a wholly owned subsidiary of Sanofi will merge with and into Provention Bio, Inc., and all of the outstanding Provention Bio, Inc. shares that are not tendered in the tender offer will be converted into the right to receive the same $25.00 per share in cash offered to Provention Bio, Inc. shareholders in the tender offer. Sanofi plans to fund the transaction with available cash resources. Subject to the satisfaction or waiver of customary closing conditions, Sanofi currently expects to complete the acquisition in the second quarter of 2023. PJT Partners is acting as exclusive financial advisor to Sanofi and Weil, Gotshal & Manges LLP is acting as its legal counsel. BofA Securities, Inc. and Centerview Partners LLC are acting as financial advisors to Provention Bio, Inc. and Ropes & Gray LLP is acting as its legal counsel. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY About Provention Bio, Inc.Provention Bio, Inc. is a commercial-stage biopharmaceutical company focused on advancing the development and commercialization of investigational therapies that may intercept and prevent debilitating and life-threatening immune-mediated diseases. The Company's pipeline includes clinical-stage product candidates that have demonstrated in pre-clinical or clinical studies proof-of-mechanism and/or proof-of-concept in autoimmune diseases, including T1D, celiac disease and lupus. Visit www.proventionbio.com for more information and follow on Twitter: @ProventionBio. Provention Bio, Inc. is listed on Nasdaq: PRVB About T1DType 1 diabetes is a condition caused by autoimmune damage of the insulin-producing beta-cells of the pancreas. As a result of this autoimmune attack, the body produces very little or no insulin which can lead to death if the insulin is not replaced. Living with T1D is complex. In addition to daily insulin injections or infusion via an insulin pump, people living with T1D also need to adopt a strict management plan which includes regular blood sugar monitoring, healthy diet and physical activity. Media RelationsSandrine Guendoul|+ 33 6 25 09 14 25 |sandrine.guendoul@sanofi.comEvan Berland |+ 1 215 432 0234 |evan.berland@sanofi.comNicolas Obrist|+ 33 6 77 21 27 55 |nicolas.obrist@sanofi.comSally Bain|+ 1 617 834 6026 |sally.bain@sanofi.com Investor RelationsEva Schaefer-Jansen|+ 33 7 86 80 56 39 |eva.schaefer-jansen@sanofi.comArnaud Delepine|+ 33 6 73 69 36 93 | arnaud.delepine@sanofi.comCorentine Driancourt|+ 33 6 40 56 92 21 | corentine.driancourt@sanofi.comFelix Lauscher|+ 1908612 7239 | felix.lauscher@sanofi.comTarik Elgoutni | + 1 617 710 3587 | tarik.elgoutni@sanofi.comNathalie Pham|+ 33 7 85 93 30 17 | nathalie.pham@sanofi.com Provention Bio, Inc. Investor RelationsKristen Keller | investorrelations@proventionbio.com Sanofi Forward-Looking Statements2This press release contains forward-looking statements. Forward-looking statements are statements that are not historical facts. These statements may include projections and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product, and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words expects, anticipates, believes, will be, intends, estimates, plans and similar expressions. Although Sanofis management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful and risks related to Sanofis ability to complete the acquisition on the proposed terms or on the proposed timeline, including the receipt of required regulatory approvals, the possibility that competing offers will be made, other risks associated with executing business combination transactions, such as the risk that the businesses will not be integrated successfully, that such integration may be more difficult, time-consuming or costly than expected or that the expected benefits of the acquisition will not be realized, as well as other risks related Sanofis business, including the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under Risk Factors and Cautionary Statement Regarding Forward-Looking Statements in Sanofis annual report on Form 20-F for the year ended December 31, 2022. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. Provention Bio, Inc. Forward-Looking Statements This press release includes forward-looking statements that are subject to risks, uncertainties and other factors that could cause actual results to differ materially from those implied by the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements, including all statements regarding the intent, belief or current expectation of Provention Bio, Inc. (Provention Bio, Inc.) and members of its senior management team and can typically be identified by words such as believe, expect, estimate, predict, target, potential, likely, continue, ongoing, could, should, intend, may, might, plan, seek, anticipate, project and similar expressions, as well as variations or negatives of these words. Forward-looking statements include, without limitation, statements regarding the proposed transaction, prospective performance, future plans, events, expectations, performance, objectives and opportunities and the outlook for Provention Bio, Inc.s business; the commercial success of Provention Bio, Inc.s products and pipeline; the expected timing of the completion of the transaction; the ability to complete the transaction considering the various closing conditions; and the accuracy of any assumptions underlying any of the foregoing. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and are cautioned not to place undue reliance on these forward-looking statements. Actual results may differ materially from those currently anticipated due to a number of risks and uncertainties. Risks and uncertainties that could cause the actual results to differ from expectations contemplated by forward-looking statements include: uncertainties as to the timing of the tender offer and merger; uncertainties as to how many of Provention Bio, Inc.s stockholders will tender their stock in the offer; the possibility that various closing conditions for the transaction may not be satisfied or waived, including that a governmental entity may prohibit, delay or refuse to grant approval for the consummation of the transaction; the occurrence of any event, change or other circumstance that could give rise to the termination of the merger agreement; the effects of the transaction (or the announcement thereof) on relationships with associates, customers, manufacturers, suppliers, other business partners or governmental entities or patient groups; transaction costs; the risk that the merger will divert managements attention from Provention Bio, Inc.s ongoing business operations; changes in Provention Bio, Inc.s businesses during the period between now and the closing; risks associated with litigation; failure to maintain FDA approval for TZIELD; uncertainties that the planned commercial launch in the U.S. for TZIELD is successful in part or at all for various reasons including the actual market size and drug supply needed may not be consistent with Provention Bio, Inc.s expectations and its executed commercial readiness plans; uncertainties as to the degree to which TZIELD is accepted by patients and prescribed by physicians; uncertainties as to the efficiency of Provention Bio, Inc.s manufacturing, sales, distribution and specialty pharmacy network in getting TZIELD to the market and future economic, competitive, reimbursement and regulatory conditions that could negatively impact the commercial launch of TZIELD; risks that the post-marketing commitment studies for TZIELD may not yield data consistent with prior results; the risk that TZIELD may cause undesirable side effects that could limit its commercial potential; the possibility that Provention Bio, Inc. is not able to execute on its business plans including meeting its expected or planned regulatory milestones and timelines, clinical development plans and successfully bringing its product candidates to market, for various reasons, including factors outside of Provention Bio, Inc.s control, such as possible limitations of Provention Bio, Inc.s financial and other resources, competition, manufacturing limitations that may not be anticipated or resolved for in a timely manner or at all, and regulatory, court or agency decisions, such as decisions by the United States Patent and Trademark Office with respect to patents that cover its product candidates, the potential for noncompliance with FDA regulations; the potential impacts of COVID-19 on Provention Bio, Inc.s business and financial results; changes in law, regulations, or interpretations and enforcement of regulatory guidance; uncertainties of patent protection and litigation; competition, other risks and uncertainties detailed from time to time in documents filed with the SEC by Provention Bio, Inc., including current reports on Form 8-K, quarterly reports on Form 10-Q and annual reports on Form 10-K, as well as the Schedule 14D-9 to be filed by Provention Bio, Inc.. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval, and commercialization of new products. All forward-looking statements are based on information currently available to Provention Bio, Inc., and Provention Bio, Inc. assumes no obligation to update any forward-looking statements, whether as a result of new information, future developments or otherwise, except as may be required by applicable law. The information set forth herein speaks only as of the date hereof. Additional Information for US Shareholders and Where to Find It The tender offer for the outstanding shares of common stock of Provention Bio, Inc. referenced in this communication has not yet commenced. This communication is for informational purposes only and is neither an offer to purchase nor a solicitation of an offer to sell shares of Provention Bio, Inc., nor is it a substitute for the tender offer materials that Sanofi and its acquisition subsidiary will file with the U.S. Securities and Exchange Commission (the SEC) upon commencement of the tender offer. At the time the tender offer is commenced, Sanofi and its acquisition subsidiary will file a tender offer statement on Schedule TO, and Provention Bio, Inc. will file a Solicitation/Recommendation Statement on Schedule 14D-9 with the SEC with respect to the tender offer. The tender offer statement on Schedule TO (including an Offer to Purchase, a related Letter of Transmittal and certain other tender offer documents) and the Solicitation/Recommendation Statement will contain important information. HOLDERS OF SHARES OF PROVENTION BIO, INC. ARE URGED TO READ THESE DOCUMENTS WHEN THEY BECOME AVAILABLE (AS EACH MAY BE AMENDED OR SUPPLEMENTED FROM TIME TO TIME) BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION THAT PROVENTION BIO, INC. STOCKHOLDERS SHOULD CONSIDER BEFORE MAKING ANY DECISION REGARDING TENDERING THEIR SHARES. The Offer to Purchase, the related Letter of Transmittal and certain other tender offer documents, as well as the Solicitation/Recommendation Statement, will be made available to all holders of shares of Provention Bio., Inc. at no expense to them. The tender offer materials and the Solicitation/Recommendation Statement will be made available for free at the SECs web site at www.sec.gov. Additional copies may be obtained for free by contacting Sanofis Investor Relations Department at ir@sanofi.com or on Sanofis website at https://en.sanofi.com/investors or by contacting Kristen Kelleher, Investor Relations, at investorrelations@proventionbio.com, or on Proventon Bio, Inc.s website, www.proventionbio.com. In addition to the Offer to Purchase, the related Letter of Transmittal and certain other tender offer documents, as well as the Solicitation/Recommendation Statement, Sanofi files annual and special reports and other information with the SEC and Provention Bio., Inc. files annual, quarterly and special reports and other information with the SEC. You may read and copy any reports or other information filed by Sanofi and Provention Bio., Inc. at the SEC public reference room at 100 F. Street, N.E., Washington D.C. 20549. Please call the Commission at 1-800-SEC-0330 for further information on the public reference room. Sanofis and Provention Bio., Inc.s filings with the SEC are also available to the public from commercial document-retrieval services and at the website maintained by the SEC at www.sec.gov 1 Based on Sanofi analysis derived from the 2020 CDC National Diabetes Statistics Report https://www.cdc.gov/diabetes/pdfs/data/statistics/national-diabetes-statistics-report.pdf Attachment Source: West Corporation 2021 Dec 21, 2021: Banco Santander Sanofi to acquire Amunix immuno-oncology pipeline with next generation Conditionally Activated Biologics Sanofi to acquire Amunix immuno-oncology pipeline with next generation Conditionally Activated Biologics PARISDecember 21,2021 Sanofi announced today that it has entered into an agreement to acquireAmunix Pharmaceuticals, Inc., an immuno-oncology company leveraging its proprietary, clinically validatedXTEN and innovative universal protease-releasable masking technology platform, Pro-XTENTM, to discover and develop transformative T-cellengagers (TCE) and cytokine therapies for patients with cancer. Amunixs pipeline, which includes lead candidate, AMX-818, a masked HER2-directed TCE, offers a strong strategic fit with Sanofis focus on developing potentially transformative cancer therapies in immuno-oncology. Under the terms of the agreement, Sanofi will acquire Amunix for an upfront payment of approximately $1 billion and up to $225 million upon achievement of certain future development milestones. The acquisition supports Sanofis efforts to accelerate and expand its contributions to innovative medicines for oncology patients, with approximately 20 molecules currently in development. This acquisition demonstrates our ongoing commitment to investing in promising research and discovery platforms, said John Reed, M.D., Ph.D., Global Head of Research & Development, Sanofi. The Amunix technology platform utilizes a next generation smart biologics approach to precisely tailor-deliver medicines to become active only in tumor tissues while sparing normal tissues, thus bringing the promise of more effective and safer treatment options for cancer patients. We are excited to rapidly advance Amunixs promising pipeline and to combine their innovative candidate medicines with complementary molecules in Sanofis immuno-oncology portfolio.Amunixs proprietary XTEN masks and cleavable linkers are a next-generation protein engineering approach that allows biologics to circulate in stealth mode, becoming active preferentially in disease specific micro-environments, with the aim to enable saferandmoreefficaciousmedicines. The technology can be applied to a wide range of existing and potentially new pipeline assets. The molecular design of Amunixs molecules endows the inactive stealth molecules with long-lasting properties, converting after activation in disease tissues to short half-life agents so that the active molecule is rapidly cleared from the body. Specifically, inimmuno-oncology, Amunixs technology offers the potential to overcome challenges that have plagued the adoption of T-Cell Engager bi-specific antibodies for solid tumors, including unwanted immune attack of normal healthy cells and systematic widespread immune system activation that leads to side effects such as Cytokine Release Syndrome. Source: West Corporation Nov 09, 2021: Banco Santander Sanofi completes acquisition of Kadmon Sanofi completes acquisition of Kadmon Paris November 9, 2021 - Sanofi announced today the completion of its acquisition of Kadmon Holdings, Inc. The acquisition further strengthens growth and expansion for the General Medicines portfolio. Shareholders of Kadmon common stock voted to approve the acquisition at a special meeting of stockholders on November 5, 2021 and will receive $9.50 per share in cash, which represents a total equity value of approximately $1.9 billion (on a fully diluted basis). Sanofi completed its acquisition of Kadmon through the merger of a wholly owned subsidiary of Sanofi with and into Kadmon, pursuant to Section 251 of the General Corporation Law of the State of Delaware, with Kadmon continuing as the surviving corporation and becoming an indirect, wholly owned subsidiary of Sanofi. As of November 9, 2021, Kadmon common stock will cease to be traded on the NASDAQ Global Select Stock Market and will be subsequently deregistered. Centerview Partners acted as exclusive financial advisor to Sanofi while Weil, Gotshal & Manges LLPacted as legal counsel to Sanofi.Cantor Fitzgerald & Co.andMoelis & Company LLCacted as exclusive financial advisors to Kadmon in the transaction, whileDLA Piper LLP (US)acted as legal counsel. H.C. Wainwright & Co., LLC acted as capital markets advisor to Kadmon management. About Sanofi Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. Source: West Corporation Sep 14, 2021: Banco Santander Sanofi completes acquisition of Translate Bio, accelerating the application of mRNA in new vaccines and therapeutics Sanofi completes acquisition of Translate Bio, accelerating the application of mRNA in new vaccines and therapeutics PARIS September 14, 2021 - Sanofi announced today the completion of its acquisition of Translate Bio, further accelerating the companys efforts to develop transformative vaccines and therapies using mRNA technology. The acquisition adds a critical pillar to the companys mRNA Center of Excellence which aims to unlock the potential of next-generation mRNA vaccines and other strategic areas such as immunology, oncology, and rare diseases. The tender offer for all of the outstanding shares of Translate Bio common stock expired as scheduled at one minute after 11:59 p.m., Eastern Time, on Monday, September 13, 2021. The minimum tender condition and all of the other conditions to the offer have been satisfied and on September 14, 2021, Sanofi accepted for payment and will promptly pay for all shares validly tendered and not validly withdrawn. Following its acceptance of the tendered shares, Sanofi completed its acquisition of Translate Bio through the merger of a wholly owned subsidiary of Sanofi with and into Translate Bio, pursuant to Section 251(h) of the General Corporation Law of the State of Delaware, with Translate Bio continuing as the surviving corporation and becoming an indirect, wholly owned subsidiary of Sanofi. In connection with the merger, all Translate Bio shares not validly tendered in the tender offer have been converted into the right to receive the same $38 per share in cash, without interest thereon and net of any applicable withholding taxes, that would have been paid had such shares been validly tendered in the tender offer. As of September 14, 2021, Translate Bio common stock will cease to be traded on the NASDAQ Global Select Stock Market. Source: West Corporation Sep 08, 2021: Banco Santander Sanofi to acquire Kadmon to further strengthen growth of transplant business Sanofi to acquire Kadmon to further strengthen growth of transplant business Adds Rezurock (belumosudil) an FDA-approved, first-in-class treatment for adult and pediatric patients 12 years and older with chronic graft-versus-host disease (cGVHD) after failure of at least two prior lines of systemic therapy PARIS and NEW YORK September 8, 2021 Sanofi has entered into a definitive merger agreement with Kadmon Holdings, Inc. (NASDAQ: KDMN) a biopharmaceutical company that discovers, develops, and markets transformative therapies for disease areas of significant unmet medical needs. The acquisition supports Sanofis strategy to continue to grow its General Medicines core assets and will immediately add Rezurock(belumosudil) to its transplant portfolio. Rezurock is a recently FDA-approved, first-in-class treatment for chronic graft-versus-host disease (cGVHD) for adult and pediatric patients 12 years and older who have failed at least two prior lines of systemic therapy. Shareholders of Kadmon common stock will receive $9.50 per share in cash, which represents a total equity value of approximately $1.9 billion (on a fully diluted basis). The Sanofi and Kadmon Boards of Directors unanimously approved the transaction. We are transforming and simplifying our General Medicines business and have shifted our focus on differentiated core assets in key markets, said Olivier Charmeil, Executive Vice President General Medicines. We are thrilled to add Kadmon's Rezurock to our well-established transplant portfolio. Our existing scale, expertise, and relationships in transplant create an ideal platform to achieve the full potential of Rezurock, which will address the significant unmet medical needs of patients with chronic graft-versus-host disease around the world. Source: West Corporation Aug 03, 2021: Banco Santander Sanofi to acquire Translate Bio; advances deployment of mRNA technology across vaccines and therapeutics development Sanofi to acquire Translate Bio; advances deployment of mRNA technology across vaccines and therapeutics development Accelerates development of current Sanofi licensed programs in vaccines and potential to explore other therapeutic areasFast tracks establishment of Sanofis recently announced mRNA Center of ExcellenceFull integration upgrades drug formulation capabilities and enhances US talent in a promising new technology PARIS and LEXINGTON, Mass August 3, 2021 As part of Sanofis endeavor to accelerate the application of messenger RNA (mRNA) to develop therapeutics and vaccines, the company has entered into a definitive agreement with Translate Bio (NASDAQ: TBIO), a clinical-stage mRNA therapeutics company, under which Sanofi will acquire all outstanding shares of Translate Bio for $38.00 per share in cash, which represents a total equity value of approximately $3.2 billion (on a fully diluted basis). The Sanofi and Translate Bio Boards of Directors unanimously approved the transaction. Translate Bio adds an mRNA technology platform and strong capabilities to our research, further advancing our ability to explore the promise of this technology to develop both best-in-class vaccines and therapeutics, said Paul Hudson, Sanofi Chief Executive Officer. A fully owned platform allows us to develop additional opportunities in the fast-evolving mRNA space. We will also be able to accelerate our existing partnered programs already under development. Our goal is to unlock the potential of mRNA in other strategic areas such as immunology, oncology, and rare diseases in addition to vaccines. Source: West Corporation Jan 11, 2021: Banco Santander Sanofi to acquire Kymab, adding KY1005 to its pipeline, a human monoclonal antibody targeting key immune system regulator OX40L Sanofi and Kymab, a clinical-stage biopharmaceutical company developing fully human monoclonal antibodies with a focus on immune-mediated diseases and immuno-oncology therapeutics, have entered into an agreement under which Sanofi will acquire Kymab for an upfront payment of approximately $1.1 billion and up to $350 million upon achievement of certain milestones. Source: West Corporation 2020 Sep 28, 2020: Banco Santander Sanofi completes Principia Biopharma Inc. acquisition The tender offer for all of the outstanding shares of Principia common stock expired as scheduled at one minute after 11:59 p.m., Eastern Time, on Friday, September 25, 2020. The minimum tender condition and all of the other conditions to the offer have been satisfied and on September 28, 2020, Sanofi and its wholly owned subsidiary Kortex Acquisition Corp. (aEURoePurchaseraEUR ), accepted for payment and will promptly pay for all shares validly tendered and not validly withdrawn. Source: West Corporation Aug 28, 2020: Banco Santander Sanofi to commence tender offer for acquisition of Principia Biopharma Inc. Sanofi to commence tender offer for acquisition of Principia Biopharma Inc. Paris, August 28 2020 - Sanofi announced today that it intends to commence a tender offer (the "Offer") today to acquire all of the outstanding shares of common stock of Principia Biopharma Inc. ("Principia") for $100 per share in cash, without interest thereon and net of any applicable withholding taxes. The Offer is being made pursuant to the Agreement and Plan of Merger, dated as of August 16, 2020 (as it may be amended from time to time, the "Merger Agreement"), by and among Principia, Sanofi and Kortex Acquisition Corp., a Delaware corporation and an indirect, wholly-owned subsidiary of Sanofi ("Purchaser"). The Offer is scheduled to expire one minute past 11:59 p.m., Eastern Time, on Friday, September 25, 2020, unless the Offer is extended in accordance with the Merger Agreement and the applicable rules and regulations of the U.S. Securities and Exchange Commission (the "SEC"). The consummation of the Offer is subject to customary closing conditions, including the tender of at least a majority of the outstanding shares of Principia common stock, the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, and other customary conditions. Following the successful completion of the Offer, Purchaser will merge with and into Principia pursuant to Section 251(h) of the General Corporation Law of the State of Delaware, with Principia continuing as the surviving corporation and becoming an indirect, wholly-owned subsidiary of Sanofi (the "Merger"). At the effective time of the Merger, the outstanding shares of common stock of Principia not tendered in the Offer will be converted into the right to receive the same $100 per share in cash that they would have received had they tendered their shares in the Offer. Source: West Corporation Aug 17, 2020: Banco Santander Sanofi to acquire Principia Biopharma Sanofi to acquire Principia Biopharma Further strengthens core R&D areas of autoimmune and allergic diseasesProvides full control of brain-penetrant BTK inhibitor SAR442168 in multiple sclerosis (MS), making commercialization more efficient and eliminating future royalty paymentsAllows expansion of SAR442168 development program into other central nervous system diseases and therapeutic areasAdds clinically advanced oral BTK inhibitor rilzabrutinib with potential across a range of immunology and inflammation indications, complementing Sanofi's existing R&D pipeline PARIS and SOUTH SAN FRANCISCO, Calif. - August 17, 2020 - Sanofi and Principia Biopharma Inc. (NASDAQ: PRNB), a late-stage biopharmaceutical company focused on developing treatments for immune-mediated diseases, entered into a definitive agreement under which Sanofi will acquire all of the outstanding shares of Principia for $100 per share in cash, which represents an aggregate equity value of approximately $3.68 billion (on a fully diluted basis). The Sanofi and Principia Boards of Directors unanimously approved the transaction. "This acquisition advances our ongoing R&D transformation to accelerate development of the most promising medicines that will address significant patient needs," said Paul Hudson, Sanofi Chief Executive Officer. "The addition of multiple BTK inhibitors to our pipeline demonstrates our commitment to strategic product acquisitions in our priority therapeutic areas. Full ownership of our brain-penetrant BTK inhibitor '168 removes complexities for this priority development program and simplifies future commercialization." Source: West Corporation Litigation 2023 Jun 27, 2023: Banco Santander Press Release: Positive topline Phase 2b data in atopic dermatitis support amlitelimab as a potential first and best-in-class novel investigational anti-OX40-ligand monoclonal antibody Positive topline Phase 2b data in atopic dermatitis support amlitelimab as a potential first and best-in-class novel investigational anti-OX40-ligand monoclonal antibody Amlitelimab shows statistically significant improvements in signs and symptoms of moderate-to-severe atopic dermatitis in adultsStudy met its primary endpoint of percentage change in Eczema Area and Severity Index score from baseline at 16 weeks, with continued improvement seen through 24 weeks; improvements also seen in key secondary endpoints at 16 and 24 weeks5th positive read-out for Sanofis pipeline since beginning of 2023Data support Sanofis Immunology strategy built around exploring disruptive mechanisms of action for people living with chronic inflammatory diseases Paris, June 27, 2023. The primary endpoint was met in a Phase 2b study (STREAM-AD) of amlitelimab in adults with moderate-to-severe atopic dermatitis whose disease cannot be adequately controlled with topical medications or for whom topical medications are not a recommended treatment approach. In this dose-ranging study, treatment with amlitelimab resulted in statistically significant improvements in average Eczema Area and Severity Index (EASI) score from baseline at 16 weeks compared to placebo for all four subcutaneous doses that were studied. There were also improvements in key secondary outcome measures and continued improvements were observed through week 24 in primary and key secondary outcomes. Biomarker results support an effect on both type 2 and non-type 2 pathways. Amlitelimab was well-tolerated in the study across all dose arms and no new safety concerns were identified. Naimish Patel, M.D.Head of Global Development, Immunology and Inflammation, SanofiWhile we have made significant strides in the treatment of atopic dermatitis, there are patients who are still in need of new options. We believe that the results from this Phase 2b study with amlitelimab support our perspective that targeting OX40-Ligand has the potential to provide a first and best-in-class treatment option that addresses type 2 and non-type 2 inflammation to meet the individual needs of people living with atopic dermatitis and other chronic inflammatory diseases. We look forward to advancing into a larger Phase 3 clinical development program and continuing to drive momentum in our Immunology pipeline to deliver first or best-in-class treatments. Amlitelimab is a fully human non-depleting monoclonal antibody that binds to OX40-Ligand, a key immune regulator, and has the potential to be a first-in-class treatment for a range of immune-mediated diseases and inflammatory disorders, including moderate-to-severe atopic dermatitis and asthma. By targeting OX40-Ligand, amlitelimab aims to restore immune homeostasis between pro-inflammatory and regulatory T cells. Detailed efficacy and safety results from this trial will be presented in a future scientific forum. Amlitelimab is currently under clinical investigation, and its safety and efficacy have not been evaluated by any regulatory authority. About STREAM-ADSTREAM-AD, a Phase 2b study, was a randomized double-blind, placebo-controlled study, evaluating amlitelimab in adult patients with moderate-to-severe atopic dermatitis whose disease was inadequately controlled with topical therapies or where such therapies were not advisable. The primary endpoint was percentage change in EASI from baseline at 16 weeks. Key secondary endpoints included change in EASI from baseline at 24 weeks, percentage of patients with at least a 75% reduction from baseline in EASI at 16 and 24 weeks, percentage of patients with a response of IGA 0 (clear) or 1 (almost clear) and a reduction from baseline 2 points at 16 and 24 weeks, and proportion of patients with improvement (reduction) of weekly average of pruritus NRS 4 with a baseline pruritus of 4 from baseline at 16 and 24 weeks. The study enrolled 390 people in Australia, Bulgaria, Canada, Czechia, Germany, Hungary, Japan, Poland, Spain, Taiwan, the United Kingdom and the United States. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Media RelationsSandrine Guendoul|+ 33 6 25 09 14 25 |sandrine.guendoul@sanofi.comSally Bain|+ 1 617 834 6026 |sally.bain@sanofi.comVictor Rouault|+ 33 6 70 93 71 40 |victor.rouault@sanofi.com Investor RelationsEva Schaefer-Jansen|+ 33 7 86 80 56 39 |eva.schaefer-jansen@sanofi.comArnaud Delepine|+ 33 6 73 69 36 93 | arnaud.delepine@sanofi.comCorentine Driancourt|+ 33 6 40 56 92 21 | corentine.driancourt@sanofi.comFelix Lauscher|+ 1908612 7239 | felix.lauscher@sanofi.comTarik Elgoutni| + 1 617 710 3587 | tarik.elgoutni@sanofi.comNathalie Pham|+ 33 7 85 93 30 17 | nathalie.pham@sanofi.com Sanofi Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words expects, anticipates, believes, intends, estimates, plans and similar expressions. Although Sanofis management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofis ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that pandemics or other global crises may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under Risk Factors and Cautionary Statement Regarding Forward-Looking Statements in Sanofis annual report on Form 20-F for the year ended December 31, 2022. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. Attachment Press_Release Source: West Corporation May 31, 2023: Banco Santander Press Release: Positive Phase 2 data of novel investigational anti-CD40L antibody frexalimab show significantly reduced disease activity in relapsing multiple sclerosis Positive Phase 2 data of novel investigational anti-CD40L antibody frexalimab show significantly reduced disease activity in relapsing multiple sclerosis Frexalimab met primary endpoint with 89% reduction in new gadolinium-enhancing T1 brain lesions achieved at Week 12 in the higher-dose treatment arm, compared with placeboSanofi plans to initiate pivotal trials in multiple sclerosis in early 2024 Paris, May 31 2023. New data, being presented in a late-breaking session at the 2023 Consortium of Multiple Sclerosis Centers (CMSC) annual meeting, demonstrate that frexalimab, Sanofis novel second-generation investigational anti-CD40L antibody, with a unique mechanism of action, significantly reduced disease activity in a Phase 2 trial of patients with relapsing multiple sclerosis (MS). Following 12 weeks of therapy, the number of new gadolinium-enhancing (GdE) T1-lesions was reduced by 89% and 79% in the higher- and lower-dose treatment arms, respectively, compared with placebo, meeting the studys primary endpoint. A substantial unmet need remains in MS for highly effective and well-tolerated treatment options that provide sustainable control of disease activity and disability progression, while minimizing risks. As the first second-generation anti-CD40L antibody to show efficacy in MS, frexalimab is thought to block the costimulatory CD40/CD40L cellular pathway necessary for adaptive (T and B cells) and innate (macrophages and dendritic cells) immune cell activation and function, without lymphocyte-depletion. Erik Wallstrom, MD, PhD Global Head of Neurology Development, Sanofi"Building on our 20 years of research and development in multiple sclerosis, we are committed to growing our robust pipeline of MS therapies by exploring multiple treatment approaches with unique MOAs that have the potential to slow or halt disability, which remains one of the greatest unmet medical needs in multiple sclerosis today. Gavin Giovannoni, MD, PhD, FCP, FRCP, FRCPathChair of Neurology, Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London"Frexalimab has a unique mechanism of action, blocking the CD40/CD40L costimulatory pathway thought to regulate both adaptive and innate immune cell activation and function a pathway that is pivotal in the pathogenesis of MS. We are thrilled with the results achieved with frexalimab in just 3 months, which shows that CD40L inhibition rapidly controls MS disease activity without lymphocyte depletion. Pivotal trials in MS are planned to be launched in 2024. About the Phase 2 studyThe Phase 2 study was a randomized, double-blind, placebo-controlled trial evaluating frexalimab in patients with relapsing MS. In the trial, 129 patients with relapsing MS were randomized (4:4:1:1) to receive either higher or lower doses of frexalimab (n=52 and n=51, respectively) or matching placebo (n=12 and n=14, respectively; pooled for efficacy analyses) for 12 weeks (Part A). After Week 12, patients receiving placebo switched to respective frexalimab arms and entered the open-label Part B, which is currently ongoing. The primary endpoint was the reduction in the number of new GdE T1-hyperintense MRI brain lesions after 12 weeks of treatment. Secondary endpoints included additional MRI-based efficacy measures as well as the safety, tolerability and pharmacokinetics of frexalimab. In the study, both groups receiving higher or lower doses of frexalimab had significant reductions in new GdE T1-hyperintense lesions after 12 weeks of treatment. At Week 12, high- and low-dose frexalimabsignificantly reduced the number of new GdE T1-lesions by 89% (95%CI: 62%-97%, p=0.0004) and 79% (95%CI: 44%-92%, p=0.0021), respectively, versus placebo (pooled dose groups). Additionally, both groups treated with frexalimab showed reductions in new or enlarging T2-lesions and total GdE T1-lesions. At Week 24, 96% of participants in the higher-dose frexalimab arm were free of new GdE T1-lesions. Early effects (Week 12) on MSIS-29 physical impact score (a patient-reported outcome) and plasma neurofilament light chain (NfL) levels will also be reported. Frexalimab was well-tolerated, and 125 (97%) patients completed Part A and continued to the open-label Part B. The most common adverse events (4%) in any frexalimab-treated group were COVID-19 (n=5 [9.8%] in the lower-dose group; all uncomplicated cases of mild or moderate intensity) and headache (n=1 [2.0%] and n=3 [5.8%] in the lower- and higher-dose group, respectively). About frexalimabFrexalimab (SAR441344) is a novel monoclonal antibody that is thought to block the costimulatory CD40/CD40L cellular pathway necessary for adaptive (T and B cells) and innate (macrophages and dendritic cells) immune cell activation and function, without lymphocyte-depletion. Sanofi is developing SAR441344 under an exclusive license from ImmuNext Inc. Frexalimab is an investigational product, and its safety and efficacy has not been reviewed by any regulatory authority. About Sanofi We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Media RelationsSandrine Guendoul|+ 33 6 25 09 14 25 |sandrine.guendoul@sanofi.comSally Bain|+ 1 617 834 6026 |sally.bain@sanofi.comInvestor RelationsEva Schaefer-Jansen|+ 33 7 86 80 56 39 |eva.schaefer-jansen@sanofi.comArnaud Delepine|+ 33 6 73 69 36 93 | arnaud.delepine@sanofi.comCorentine Driancourt|+ 33 6 40 56 92 21 | corentine.driancourt@sanofi.comFelix Lauscher|+ 1908612 7239 | felix.lauscher@sanofi.comTarik Elgoutni|+ 1 617 710 3587 |tarik.elgoutni@sanofi.comNathalie Pham|+ 33 7 85 93 30 17 | nathalie.pham@sanofi.com Sanofi Forward Looking Statement This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words expects, anticipates, believes, intends, estimates, plans and similar expressions. Although Sanofis management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofis ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that pandemics or other global crises may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under Risk Factors and Cautionary Statement Regarding Forward-Looking Statements in Sanofis annual report on Form 20-F for the year ended December 31, 2022. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. Attachment Press_Release Source: West Corporation 2022 Nov 30, 2022: Banco Santander Press Release: Acoziborole: Investigational single-dose oral treatment raises hope for elimination of sleeping sickness in Africa Acoziborole: Investigational single-dose oral treatment raises hope for elimination of sleeping sickness in Africa Positive Phase II/III study results support acoziboroles potential in treatment for deadly disease Geneva, Kinshasa, Paris November 30, 2022. The Drugs for Neglected Diseases initiative (DNDi) and Sanofi announce treatment success rates of up to 95% from a Phase II/III study investigating the safety and efficacy of single-dose acoziborole, a potentially transformative investigational treatment for sleeping sickness, published today in The Lancet Infectious Diseases medical journal. The clinical trial was led by DNDi and its partners in the Democratic Republic of the Congo (DRC) and Guinea. Dr Victor KandeFormer Neglected Tropical Diseases Expert Advisor at the Ministry of Health of the DRC, principal investigator of the trial, and lead author of the Lancet article Sleeping sickness is a nightmare disease that affects patients in some of the most remote settings in West and Central Africa, where distance from hospital can be measured in days. We are now on the cusp of a potential treatment that can be given in one day, in a single dose of three pills this would be a revolution for doctors and communities. Transmitted by the bite of an infected tsetse fly, sleeping sickness is fatal without treatment. In the early stage of the disease, people suffer from headaches or fever. In the late stage, the parasite crosses the blood-brain barrier and invades the central nervous system, causing neuropsychiatric symptoms such as sleep disruption, confusion, lethargy, and convulsions and ultimately, death. Never been so close to elimination in decades Treatment for sleeping sickness has radically improved in the last decade, thanks to the successes of a partnership bringing together DNDi, Sanofi, the national sleeping sickness control programmes of the DRC and Guinea, the World Health Organization (WHO), Medecins Sans Frontieres (MSF), and other partners. The number of reported cases of sleeping sickness has fallen sharply in the last 20 years, from almost 40,000 reported cases in 1998 (with estimates of over 300,000 undiagnosed cases) to less than 1,000 in 2020. Though an encouraging trend, it should not be a reason for complacency, as the disease is known to resurge in the form of devastating outbreaks. Dr Antoine TarralHead of the sleeping sickness programme at DNDi and co-author of the paperBy simplifying the treatment paradigm, acoziborole would be an innovation that enables a sustainable response to sleeping sickness for health systems. With these new data, we have hope that we may be able to finally eliminate the disease, once and for all, by opening the door to a screen-and-treat' approach at the village level. Dr Wilfried Mutombo KalonjiDNDi Clinical Project Leader and Medical Manager, and co-author of the paper Acoziborole has the potential to have a major impact on sleeping sickness treatment. This is a complicated disease, with patients living in very remote and unstable areas. We need simple approaches. We now have the promise of single-dose, oral treatment that doesnt need to be taken with food, removes the need for hospitalization, removes the need for complex or invasive diagnosis or disease staging, and requires minimal training. In many ways, it doesnt get any simpler than this. The WHO Neglected Tropical Diseases Roadmap strategy sets a goal of interrupting transmission of the gambiense strain of human African trypanosomiasis (g-HAT), the scientific name of the disease, by 2030. (The gambiense strain accounts for 93% of all sleeping sickness cases). In alignment with this strategy, acoziborole could open the possibility of a simple screen-and-treat approach, whereby any person whose rapid pinprick blood test suggests they might be infected could be treated with acoziborole, without the need for more complex parasitological confirmation or hospitalization. About the Phase II/III study Between 2016 and 2019, DNDi and its partners led an open-label, Phase II/III study to assess the safety and efficacy of acoziborole in patients with early- and late-stage g-HAT. 208 patients were recruited at 10 hospitals in the DRC and Guinea. The 18-month treatment success rate for acoziborole was 95% in late-stage g-HAT patients, corresponding to the best results from studies with existing treatments (94%). In addition, 100% of the 41 patients with early-stage g-HAT were considered as treatment successes at all timepoints. The study shows that acoziborole has a favourable safety profile, with no significant drug-related safety signals reported. These pivotal results will form the basis of Sanofis dossier submission to the European Medicines Agency (EMA) and represent another milestone in the quest to eliminate sleeping sickness. Upon the EMAs positive opinion and local approval, Sanofi will donate acoziborole to the WHO through its philanthropic organization, Foundation S The Sanofi Collective. Acoziborole is currently under clinical investigation and its safety and efficacy have not been evaluated by any regulatory authority. Dietmar Berger, MD, PhDHead of Development and Chief Medical Officer, SanofiSanofi is a long-standing partner in the fight against sleeping sickness alongside DNDi and the World Health Organization. We are leveraging Sanofis unique expertise in developing, registering and producing new, innovative medicines to address areas of significant unmet need and in this case, support the World Health Organizations goal to eliminate sleeping sickness in humans by 2030. Dr Mariame Camaraprincipal investigator of the study at the HAT Treatment Centre in Dubreka, Guinea and co-author of the Lancet articleMany sleeping sickness patients live in remote villages in the mangrove swamps along the coast of Guinea even though we have good treatment options now, we still need to send people who test positive with a sleeping sickness rapid test from their village to a confirmatory health centre. Acoziborole could potentially become the first treatment that would allow doctors to treat people on the spot, once they receive a positive rapid test in their village. About the DNDi programme for the development of acoziborole The DNDi programme for the development of acoziborole was supported by grants from the Bill & Melinda Gates Foundation; UK aid; the Federal Ministry of Education and Research (BMBF) through KfW, Germany; the Swiss Agency for Development and Cooperation (SDC); Medecins Sans Frontieres; the Dutch Ministry of Foreign Affairs (DGIS); the Norwegian Agency for Development Cooperation (Norad), Norwegian Ministry of Foreign Affairs, as part of Norways in-kind contribution to EDCTP2; Stavros Niarchos Foundation; the Spanish Agency for International Development Cooperation (AECID); and the BBVA Foundation (through the Frontiers of Knowledge Award in Development Cooperation). About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY About DNDiA not-for-profit research and development organization, DNDi works to deliver new treatments for neglected patients, those living with Chagas disease, sleeping sickness (human African trypanosomiasis), leishmaniasis, filarial infections, mycetoma, paediatric HIV, hepatitis C, and dengue. DNDi is also coordinating the ANTICOV clinical trial to find treatments for mild-to-moderate COVID-19 cases in low-resource settings. Since its inception in 2003, DNDi has delivered twelve new treatments to date, including new drug combinations for kala-azar, two fixed-dose antimalarials, and DNDis first successfully developed new chemical entity, fexinidazole, approved in 2018 for the treatment of both stages of sleeping sickness. dndi.org Media Relations SanofiSandrine Guendoul|+ 33 6 25 09 14 25 |sandrine.guendoul@sanofi.comEvan Berland | +1 215 432 0234 | evan.berland@sanofi.comVictor Rouault|+ 33 6 70 93 71 40 |victor.rouault@sanofi.com Investor Relations SanofiEva Schaefer-Jansen|+ 33 7 86 80 56 39 |eva.schaefer-jansen@sanofi.comCorentine Driancourt|+ 33 6 40 56 92 21 | corentine.driancourt@sanofi.com Media Relations DNDiFrederic Ojardias (DNDi Geneva) | +41 79 431 62 16 | fojardias@dndi.orgIlan Moss (DNDi New York) | +1 646 266 5216 | imoss@dndi.orgFrancine Ngalula (DNDi Kinshasa) | + 243 816 402389 | francinengal@gmail.com Notes for the editorsAcoziborole is the first oral single-dose new chemical entity to be issued from DNDis lead optimization programme for sleeping sickness. It started with an initial hit identified in the chemical library of Anacor Pharmaceuticals, which was acquired by Pfizer in 2016. The initial structure was then optimized with Scynexis and Pace University and was then selected as a candidate for development and Phase I safety studies conducted successfully in France.Acoziborole is the latest innovation brought by two decades of innovation efforts by DNDi, Sanofi, and partners. In 2009, they developed a combination of existing drugs known as NECT, which was extremely effective and much safer than the toxic arsenic derivative that doctors had to use at the time. A donation programme was set up by Sanofi and Bayer to the World Health Organization (WHO), radically improving treatment options for patients.But NECT requires complex logistics, with each treatment weighing 8 kg, and must be administered in hospital settings with skilled staff. In 2018, DNDi, Sanofi, and partners developed fexinidazole, which became the first all-oral treatment available for sleeping sickness. This 10-day treatment is now available in all sleeping sickness-endemic countries. Acoziborole can be administered as a single oral dose, meaning treatment could be done in villages: healthcare workers from mobile teams will be able to immediately administer a single pill of acoziborole as soon as the patient is diagnosed, without the need of hospitalization or supervision of the treatment at home. This means it could become a major tool to facilitate the efforts to finally eliminate sleeping sickness. Sanofi Forward-Looking Statements This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words expects, anticipates, believes, intends, estimates, plans and similar expressions. Although Sanofis management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofis ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under Risk Factors and Cautionary Statement Regarding Forward-Looking Statements in Sanofis annual report on Form 20-F for the year ended December 31, 2021. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. Attachment Press_Release Source: West Corporation 2021 Jun 11, 2021: Banco Santander New pivotal data at EHA 2021 reinforces sutimlimab as a first-in-class investigational C1s inhibitor with the potential to be the first approved treatment for hemolysis in people with CAD, a serious and chronic autoimmune hemolytic anemia New pivotal data at EHA 2021 reinforces sutimlimab as a first-in-class investigational C1s inhibitor with the potential to be the first approved treatment for hemolysis in people with cold agglutinin disease, a serious and chronic autoimmune hemolytic anemia Phase 3 data from the CADENZA study met the primary composite endpoint with statistical significance; secondary endpoint data were clinically meaningfulFindings provide further evidence that sutimlimab results in rapid inhibition of C1-activated hemolysis within one week of treatment and had a sustained treatment effect throughout the study PARIS June 11, 2021 Results from Part A of CADENZA, a pivotal Phase 3 double-blind, placebo-controlled study evaluating the safety and efficacy of sutimlimab in people with cold agglutinin disease (CAD) without a recent history of blood transfusion (within the prior six months), will be presented in an oral session at the European Hematology Association 2021 Congress. The data demonstrated treatment with sutimlimab resulted in rapid and sustained inhibition of C1-activated hemolysis in people with CAD, noted within one week of treatment, and clinically significant improvements in hemoglobin and fatigue when compared to placebo during the course of the study. Cold agglutinin disease causes the bodys immune system to mistakenly destroy its healthy red blood cells. People living with cold agglutinin disease experience the crippling impact of chronic hemolysis that can cause severe anemia, profound fatigue and can have acute hemolytic crisis, said principal investigator and presenting author Professor Alexander Roth, M.D., Department of Hematology and Stem Cell Transplantation, University Hospital, University of Duisburg-Essen, Germany. The positive evidence from the CADENZA trial demonstrate significant improvements in hemolysis and meaningful impact on key measures of anemia and fatigue. Source: West Corporation 2020 Nov 19, 2020: Banco Santander FDA issues Complete Response Letter for sutimlimab, an investigational treatment for hemolysis in adults with cold agglutinin disease PARIS - November 14, 2020 - The U.S. Food and Drug Administration issued a Complete Response Letter (CRL) regarding the Biologics License Application (BLA) for sutimlimab, an investigational monoclonal antibody for the treatment of hemolysis in adults with cold agglutinin disease. Source: West Corporation Jun 16, 2020: Banco Santander Sanofi's investigational enzyme replacement therapy shows clinically meaningful improvement in critical manifestations of late-onset Pompe disease Sanofi's investigational enzyme replacement therapy shows clinically meaningful improvement in critical manifestations of late-onset Pompe disease Avalglucosidase alfa showed a 2.4-point improvement in percent-predicted forced vital capacity, an important measure of respiratory function in Pompe disease, compared to alglucosidase alfa (standard of care) Patients treated with avalglucosidase alfa walked 30 meters farther than those treated with standard of care, as measured by the 6-minute walk testGlobal regulatory submissions anticipated in the second half of 2020 PARIS - June 16, 2020 - Sanofi's investigational enzyme replacement therapy (ERT), avalglucosidase alfa, showed clinically meaningful improvement in critical manifestations (respiratory impairment and decreased mobility) of late-onset Pompe disease (LOPD) according to results from the Phase 3 trial presented today at a Sanofi-hosted scientific session. Avalglucosidase alfa met the primary endpoint demonstrating non-inferiority in improving respiratory function compared to alglucosidase alfa (standard of care) in patients with LOPD. These data will form the basis for global regulatory submissions anticipated in the second half of this year. The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy and Fast Track designations to avalglucosidase alfa for the treatment of patients with Pompe disease. The trial primary endpoint evaluated the change in respiratory muscle function using percent-predicted forced vital capacity (FVC) in the upright position. Patients treated with avalglucosidase alfa had a 2.4-point greater improvement in percent-predicted FVC compared to patients treated with standard of care (95% CI, -0.13 / 4.99), a numerical improvement in respiratory function that surpassed the study-designed measure of non-inferiority (p=0.0074). Source: West Corporation Meetings 2023 May 25, 2023: Banco Santander Press Release: Annual General Meeting of May 25, 2023 Frederic Oudea new Chairman of the Board of Directors Annual General Meeting of May 25, 2023 Frederic Oudea new Chairman of the Board of Directors Approval of the financial statements for the fiscal year 2022Distribution of a cash dividend of 3.56 per share, with payment as of June 1st, 2023Board composition: Frederic Oudea becomes Independent Director and Chairman of the Board Paris, May 25, 2023. The Combined General Shareholders Meeting of Sanofi was held on May25, 2023, under the chairmanship of Serge Weinberg. The General Meeting approved the individual Company and consolidated financial statements for the fiscal year 2022. The General Meeting decided on the distribution of an ordinary annual dividend of 3.56 per share. The payment of the dividend will be made on June 1st, 2023. The General Meeting also approved the appointment of Frederic Oudea as Independent Director.The Board of Directors, in its meeting held after the General Meeting, appointed Frederic Oudea as Chairman of the Board of Directors to succeed Serge Weinberg whose term of office expired at the end of the General Meeting. Serge Weinberg has been appointed as Honorary Chairman. On the proposal of the Appointments, Governance and CSR Committee, Frederic Oudea has been appointed as the Chairman of the Strategy Committee, member of the Appointments, Governance and CSR Committee and of the Scientific Committee. Frederic OudeaChairman of SanofiI am very pleased to join the board of Director and feel privileged to take on the role of Chairman. I would like to express Sanofis appreciation for Serge Weinbergs exceptional leadership during his thirteen years as Chairman, bringing the Company to an all-time high value and on a momentum to further transform itself on the back of leadership in immunology and inflammation. He carried his mission with upmost integrity and commitment, in the best interest of the company. I thank the shareholders and the Board of Directors for their trust. I am extremely motivated by the further advancement of science and growth that Sanofi has the opportunity to achieve and its purpose to chase the miracles of science to improve peoples lives. Im looking forward at ensuring a sustainable growth and development under the highest standards of corporate governance. Following the General Meeting, the Board of Directors remains comprised of 16 members, of whom six are women and two are Directors representing employees. The proportion of independent Board members increased from 71% to 79%. The voting results and the videocast of the Annual General Meeting are available here. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Media RelationsSandrine Guendoul|+ 33 6 25 09 14 25 |sandrine.guendoul@sanofi.comNicolas Obrist|+ 33 6 77 21 27 55 |nicolas.obrist@sanofi.comVictor Rouault|+ 33 6 70 93 71 40 |victor.rouault@sanofi.com Investor RelationsEva Schaefer-Jansen|+ 33 7 86 80 56 39 |eva.schaefer-jansen@sanofi.comArnaud Delepine|+ 33 6 73 69 36 93 | arnaud.delepine@sanofi.comCorentine Driancourt|+ 33 6 40 56 92 21 | corentine.driancourt@sanofi.comFelix Lauscher|+ 1908612 7239 | felix.lauscher@sanofi.comTarik Elgoutni| + 1 617 710 3587 | tarik.elgoutni@sanofi.comNathalie Pham|+ 33 7 85 93 30 17 | nathalie.pham@sanofi.com Attachment Press_Release Source: West Corporation May 04, 2023: Banco Santander Sanofi: COMBINED GENERAL MEETING OF MAY 25, 2023 - AVAILABILITY OF PREPARATORY DOCUMENTS COMBINED GENERAL MEETING OF MAY 25, 2023 AVAILABILITY OF PREPARATORY DOCUMENTS The Companys shareholders are invited to attend the Combined General Meeting to be held on Thursday May 25, 2023 at 2:30 p.m. (CET) at the Palais des Congres Grand Amphitheatre 2, place de la Porte Maillot 75017 Paris. The notice of meeting (avis de reunion), including the agenda and the draft resolutions as well as the terms and conditions for participating and voting in the meeting, was published on the website of the Bulletin des Annonces Legales Obligatoires BALO (www.journal-officiel.gouv.fr/balo) on April 7, 2023, bulletin n42. The notice of meeting (avis de convocation) will be published on the website of the Bulletin des Annonces Legales Obligatoires BALO (www.journal-officiel.gouv.fr/balo) on May 5, 2023. The preparatory documents for this meeting will be made available to the shareholders in accordance with the applicable legal and regulatory provisions. For registered shareholders, you will receive your notice of the General Meeting directly by post or by e-mail, depending on your choice. To request additional documents, you must complete the document request form on page 71 of the notice of meeting and return it to Uptevia, Service Assemblees Generales - C.T.O. Assemblees Generales - Les Grands Moulins de Pantin 9, rue du Debarcadere - 93761 Pantin Cedex, no later than May 20, 2023. For bearer shareholders, you should contact your financial intermediary. In accordance with Article R. 22-10-23 of the French Commercial Code, the preparatory documents for this meeting are available on the Companys website: www.sanofi.com/en/investors/financial-results-and-events/general-meetings/AGM-2023. We invite you to regularly consult the Annual General Meetings section of our website, which will be updated with any changes regarding the participation in the meeting. * * * Attachment Sanofi - AGM 25.05.2023 - Availability of Preparatory documents - EN Source: West Corporation 2022 May 03, 2022: Banco Santander Press Release: Annual General Meeting of May 3, 2022 Annual General Meeting of May 3, 2022 Approval of the financial statements for the fiscal year 2021Distribution of a cash dividend of 3.33 per share and a dividend in kind of EUROAPI shares, at a ratio of one (1) EUROAPI share per twenty-three (23) Sanofi shares, with payment as of May 10, 2022Board composition: renewals and appointment of three new Independent Directors Paris, May 3, 2022. The Combined General Shareholders Meeting of Sanofi was held on May3, 2022 at Paris Expo Porte de Versailles, under the chairmanship of Serge Weinberg. All resolutions submitted to the vote were adopted by the shareholders. The General Meeting approved the individual Company and consolidated financial statements for the fiscal year 2021. The General Meeting decided on the distribution of an ordinary annual dividend of 3.33 per share and an additional dividend in kind in the form of an allocation of EUROAPI shares, at a ratio of one (1) EUROAPI share per twenty-three (23) Sanofi shares held. The payment of the dividend, including both the cash dividend and the dividend in kind, will be made on May 10, 2022. The General Meeting also renewed Paul Hudson, Christophe Babule, Patrick Kron and Gilles Schnepp as Directors, and approved the appointment of Carole Ferrand, Emile Voest and Antoine Yver. On the proposal of the Nomination, Governance and CSR Committee, Carole Ferrand has been appointed as member of the Audit Committee, Barbara Lavernos as member of the Nomination, Governance and CSR Committee, Wolfgang Laux as member of the Compensation Committee, and Emile Voest and Antoine Yver as members of the Scientific Committee. Following the General Meeting, the Board of Directors is comprised of 16 members, of whom six are women and two are Directors representing employees. The Board of Directors remains for a large majority comprised of Independent Directors. The voting results and the videocast of the Annual General Meeting are available on: www.sanofi.com/AG2022 About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Media RelationsSandrine Guendoul|+ 33 6 25 09 14 25 |sandrine.guendoul@sanofi.comNicolas Obrist|+ 33 6 77 21 27 55 |nicolas.obrist@sanofi.comVictor Rouault|+ 33 6 70 93 71 40 |victor.rouault@sanofi.com Investor RelationsEva Schaefer-Jansen|+ 33 7 86 80 56 39 |eva.schaefer-jansen@sanofi.com Sanofi Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words expects, anticipates, believes, intends, estimates, plans and similar expressions. Although Sanofis management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofis ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. Any material effect of COVID-19 on any of the foregoing could also adversely impact us. This situation is changing rapidly and additional impacts may arise of which we are not currently aware and may exacerbate other previously identified risks. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under Risk Factors and Cautionary Statement Regarding Forward-Looking Statements in Sanofis annual report on Form 20-F for the year ended December 31, 2021. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. Attachment Press Release Source: West Corporation Apr 12, 2022: Banco Santander Sanofi - AGM 03.05.2022 - Availability of Preparatory Documents COMBINED GENERAL MEETING OF MAY 3, 2022 AVAILABILITY OF PREPARATORY DOCUMENTS The Companys shareholders are invited to attend the Combined General Meeting to be held on Tuesday May 3, 2022 at 2:30 p.m. (CET) at Paris Expo Porte de Versailles 1, Place de la Porte de Versailles, Hall 5.1 75015 Paris. The notice of meeting (avis de reunion), including the agenda and the draft resolutions as well as the terms and conditions for participating and voting in the meeting, was published on the website of the Bulletin des Annonces Legales Obligatoires BALO (www.journal-officiel.gouv.fr/balo) on March 25, 2022, bulletin n36. The notice of meeting (avis de convocation) was published on the website of the Bulletin des Annonces Legales Obligatoires BALO (www.journal-officiel.gouv.fr/balo) on April 11, 2022, bulletin n43. The preparatory documents for this meeting will be made available to the shareholders in accordance with the applicable legal and regulatory provisions. For registered shareholders, you will receive your notice of the General Meeting directly by post or by e- mail, depending on your choice. To request additional documents, you must complete the document request form on page 57 of the notice of meeting and return it to BNP Paribas Securities Services, Service Assemblees Generales - C.T.O. Assemblee Generales - Les Grands Moulins de Pantin 9, rue du Debarcadere- 93761 Pantin Cedex, no later than April 28, 2022. For bearer shareholders, you should contact your financial intermediary. In accordance with Article R.22-10-23 of the French Commercial Code, the preparatory documents for thismeeting are available on the Companys website: www.sanofi.com/AG2022. * * * Attachment Sanofi - AGM 03.05.2022 - Availability of Preparatory documents - EN vF Source: West Corporation Feb 26, 2022: Banco Santander Late-breaking phase 3 data at 2022 AAAAI Annual Meeting show Dupixent (dupilumab) significantly reduced itch and hives in patients with chronic spontaneous urticaria Late-breaking phase 3 data at 2022 AAAAI Annual Meeting show Dupixent (dupilumab) significantly reduced itch and hives in patients with chronic spontaneous urticaria In this Phase 3 trial, Dupixent added to standard-of-care antihistamines nearly doubled reduction in itch and urticaria activity scores compared to standard-of-care alone at 24 weeks in biologic-naive patients uncontrolled on antihistamines Data reinforce the potential of targeting IL-4 and IL-13, key drivers of type 2 inflammation, in this complex, chronic diseaseData support the well-established safety profile of Dupixent Paris and Tarrytown, N.Y., February 26, 2022. Detailed results from a Phase 3 trial showed that adding Dupixent (dupilumab) to standard-of-care antihistamines significantly reduced itch and hives at 24 weeks in biologic-naive patients with chronic spontaneous urticaria (CSU) compared to antihistamines alone in this investigational setting. These results will be presented today in a late-breaking session at the American Academy of Allergy, Asthma and Immunology (AAAAI) Annual Meeting. Marcus Maurer, M.D.Professor of Dermatological Allergology, Clinic for Dermatology, Venerology and Allergology at the Charite University of Medicine in Berlin, Germany Despite standard-of-care antihistamines, many patients with chronic spontaneous urticaria continue to struggle with extreme itch, burning and pain associated with hives and swelling under the skin, which can significantly disrupt their daily lives. These encouraging results showed that, in those unable to achieve disease control on antihistamines alone, patients who added dupilumab experienced improved signs and symptoms and better control of their disease. Topline results from the randomized, double-blind, placebo-controlled Phase 3 trial, which met primary and all key secondary endpoints at week 24, were announced in July 2021. Data presented at AAAAI 2022 showed that patients who added Dupixent to standard-of-care antihistamines nearly doubled the reduction in itch and urticaria activity compared to standard-of-care alone (referred to as placebo) with continuous improvement out to 24 weeks. These patients experienced a: 63% reduction in itch severity with Dupixent versus 35% with placebo, as measured by a 0-21 point itch severity scale (10.24 point reduction with Dupixent versus 6.01 point reduction with placebo, p<0.001), the primary endpoint in the U.S. (secondary endpoint in the EU).65% reduction in urticaria activity (itch and hive) severity with Dupixent versus 37% with placebo, as measured by a 0-42 point urticaria activity scale (20.53 point reduction with Dupixent versus 12.00 point reduction with placebo, p<0.001), the primary endpoint in EU (secondary endpoint in the U.S.) The trial demonstrated safety results similar to the known safety profile of Dupixent in its approved dermatological indications For the 24-week treatment period, overall rates of adverse events were generally similar between the Dupixent and placebo groups (50% Dupixent, 59% placebo). The most common adverse event was injection site reactions (11% Dupixent, 13% placebo). The potential use of Dupixent in CSU is currently under clinical development, and the safety and efficacy have not been fully evaluated by any regulatory authority. About Chronic Spontaneous Urticaria (CSU)CSU is a chronic inflammatory skin disease characterized by the sudden onset of hives on the skin and/or swelling deep under the skin. Despite standard-of-care treatment, people with CSU often experience symptoms including a persistent itch or burning sensation, which can be debilitating and significantly impact quality of life. Swelling often occurs on the face, hands and feet, but can also affect the throat and upper airways. CSU is typically treated with antihistamines, but the disease remains uncontrolled for up to 50% of patients who have limited available treatment options. More than 300,000 people in the U.S. have moderate-to-severe CSU that does not respond adequately to antihistamines alone. About the Dupixent Phase 3 CSU Program (LIBERTY-CUPID)Study A of the Phase 3 randomized, double-blind, placebo-controlled LIBERTY-CUPID clinical program evaluated the efficacy and safety of Dupixent as an add-on therapy to standard-of-care antihistamines compared to antihistamines alone in 138 patients aged 6 years and older with CSU who remained symptomatic despite antihistamine use and were not previously treated with omalizumab (i.e., biologic-naive). The primary endpoints assessed the change from baseline in itch (measured by the weekly itch severity score [ISS7], 0-21 scale) and the change from baseline in itch and hives (measured by the weekly urticaria activity score [UAS7], 0-42 scale) at 24 weeks. Study B of the CSU clinical program evaluated Dupixent in patients with chronic spontaneous urticaria (CSU), who were refractory to omalizumab, was recently stopped due to futility based on a pre-specified interim analysis, although numeric improvements were observed across key endpoints. The safety data were generally consistent with Study A and the known safety profile of Dupixent in its approved dermatological indications. The companies remain committed to advancing Dupixent for patients with CSU uncontrolled on antihistamines and are evaluating next steps based on results across both trials in the Phase 3 program. About DupixentDupixent is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not an immunosuppressant. IL-4 and IL-13 are key and central drivers of the type 2 inflammation that plays a major role in atopic dermatitis, asthma and chronic rhinosinusitis with nasal polyposis (CRSwNP). In the U.S., Dupixent is approved in patients aged 6 years and older with uncontrolled moderate-to-severe atopic dermatitis; as an add-on maintenance treatment of patients aged 6 years and older with moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid-dependent asthma; and for use with other medicines for the maintenance treatment of chronic rhinosinusitis with nasal polyposis (CRSwNP) in adults whose disease is not controlled. Dupixent is also approved in Europe, Japan and other countries around the world for use in specific patients with moderate-to-severe atopic dermatitis and certain patients with asthma or CRSwNP in different age populations. Dupixent is approved in one or more of these indications in more than 60 countries around the world, and more than 350,000 patients have been treated globally. Dupilumab Development ProgramDupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement. To date, dupilumab has been studied across 60 clinical trials involving more than 10,000 patients with various chronic diseases driven in part by type 2 inflammation. In addition to the currently approved indications, Sanofi and Regeneron are studying dupilumab in a broad range of diseases driven by type 2 inflammation or other allergic processes, including pediatric atopic dermatitis (6 months to 5 years of age, Phase 3), chronic obstructive pulmonary disease with evidence of type 2 inflammation (Phase 3), eosinophilic esophagitis (Phase 3), bullous pemphigoid (Phase 3), prurigo nodularis (Phase 3), CSU (Phase 3), chronic inducible urticaria-cold (Phase 3), chronic rhinosinusitis without nasal polyposis (Phase 3), allergic fungal rhinosinusitis (Phase 3), allergic bronchopulmonary aspergillosis (Phase 3) and peanut allergy (Phase 2). These potential uses of dupilumab are currently under clinical investigation, and the safety and efficacy in these conditions have not been fully evaluated by any regulatory authority. About Regeneron Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, hematologic conditions, infectious diseases and rare diseases. Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite technologies, such as VelocImmune, which uses unique genetically humanized mice to produce optimized fully human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world. For additional information about the company, please visit www.regeneron.com or follow @Regeneron on Twitter. About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve peoples lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Sanofi Media RelationsSally Bain | + 1 617 834 6026 | sally.bain@sanofi.com Sanofi Investor RelationsEva Schaefer-Jansen | + 33 7 86 80 56 39 | eva.schaefer-jansen@sanofi.com Arnaud Delepine | + 33 06 73 69 36 93 | arnaud.delepine@sanofi.com Corentine Driancourt | + 33 06 40 56 92 | corentine.driancourt@sanofi.com Felix Lauscher | + 1 908 612 7239 | felix.lauscher@sanofi.com Priya Nanduri | priya.nanduri@sanofi.com Nathalie Pham | + 33 07 85 93 30 17 | nathalie.pham@sanofi.com Regeneron Media RelationsHannah Kwagh | + 1 914 847 6314 | hannah.kwagh@regeneron.com Regeneron Investor RelationsVesna Tosic | + 914 847 5443 | vesna.tosic@regeneron.com Sanofi Forward-Looking Statements This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements are generally identified by the words expects, anticipates, believes, intends, estimates, plans and similar expressions. Although Sanofis management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. Any material effect of COVID-19 on any of the foregoing could also adversely impact us. This situation is changing rapidly and additional impacts may arise of which we are not currently aware and may exacerbate other previously identified risks. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under Risk Factors and Cautionary Statement Regarding Forward-Looking Statements in Sanofis annual report on Form 20-F for the year ended December 31, 2021. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. Regeneron Forward-Looking Statements and Use of Digital Media This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. (Regeneron or the Company), and actual events or results may differ materially from these forward-looking statements. Words such as anticipate, expect, intend, plan, believe, seek, estimate, variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the impact of SARS-CoV-2 (the virus that has caused the COVID-19 pandemic) on Regenerons business and its employees, collaborators, and suppliers and other third parties on which Regeneron relies, Regenerons and its collaborators ability to continue to conduct research and clinical programs, Regenerons ability to manage its supply chain, net product sales of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, Regenerons Products), and the global economy; the nature, timing, and possible success and therapeutic applications of Regenerons Products and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, Regenerons Product Candidates) and research and clinical programs now underway or planned, including without limitation Dupixent (dupilumab) for the treatment of chronic spontaneous urticaria (CSU); the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators or licensees, such as Study A of the LIBERTY-CUPID clinical program discussed in this press release, may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; uncertainty of the utilization, market acceptance, and commercial success of Regenerons Products (such as Dupixent) and Regenerons Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary), including the studies discussed or referenced in this press release, on any of the foregoing or any potential regulatory approval of Regenerons Products (such as Dupixent for the treatment of CSU) and Regenerons Product Candidates; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regenerons Product Candidates and new indications for Regenerons Products, such as Dupixent for the treatment of CSU, pediatric atopic dermatitis, chronic obstructive pulmonary disease with evidence of type 2 inflammation, eosinophilic esophagitis, bullous pemphigoid, prurigo nodularis, chronic inducible urticaria-cold, chronic rhinosinusitis without nasal polyposis, allergic fungal rhinosinusitis, allergic bronchopulmonary aspergillosis, peanut allergy, and other potential indications; the ability of Regenerons collaborators, licensees, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regenerons Products and Regenerons Product Candidates; the ability of Regeneron to manage supply chains for multiple products and product candidates; safety issues resulting from the administration of Regenerons Products (such as Dupixent) and Regenerons Product Candidates in patients, including serious complications or side effects in connection with the use of Regenerons Products and Regenerons Product Candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict Regenerons ability to continue to develop or commercialize Regenerons Products and Regenerons Product Candidates, including without limitation Dupixent; ongoing regulatory obligations and oversight impacting Regenerons Products, research and clinical programs, and business, including those relating to patient privacy; the availability and extent of reimbursement of Regenerons Products from third-party payers, including private payer healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payers and new policies and procedures adopted by such payers; competing drugs and product candidates that may be superior to, or more cost effective than, Regenerons Products and Regenerons Product Candidates; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license, collaboration, or supply agreement, including Regenerons agreements with Sanofi, Bayer, and Teva Pharmaceutical Industries Ltd. (or their respective affiliated companies, as applicable) to be cancelled or terminated; and risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA (aflibercept) Injection, Dupixent, Praluent (alirocumab), and REGEN-COV (casirivimab and imdevimab)), other litigation and other proceedings and government investigations relating to the Company and/or its operations, the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regenerons business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regenerons filings with the U.S. Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2021. Any forward-looking statements are made based on managements current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise. Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regenerons media and investor relations website (http://newsroom.regeneron.com) and its Twitter feed (http://twitter.com/regeneron). Attachment Source: West Corporation 2021 May 19, 2021: Banco Santander Sanofi to showcase data from its transformative oncology pipeline at 2021 ASCO Meeting Sanofi to showcase data from its transformative oncology pipeline at 2021 ASCO Meeting Early clinical data for investigational oral selective estrogen receptor (SERD), amcenestrant, show potential to become a new endocrine backbone therapy in ER+ HER2- breast cancerData that reinforce Libtayo (cemiplimab-rwlc) as a standard of care in advanced non-melanoma skin cancer and advanced non-small cell lung cancer, including new data in historically underrepresented patients with brain metastasesLonger term data and new analyses for Sarclisa (isatuximab-irfc) further strengthen efficacy profile, including for elderly patients and patients with high-risk cytogenetic abnormalities PARIS May 19, 2021 New research being presented at the upcoming virtual American Society of Clinical Oncology (ASCO) Annual Meeting from June 4-8 highlights Sanofis transformative science and commitment to patient care across difficult-to-treat cancers, including multiple myeloma, skin, lung and breast cancers.Our pipeline of innovative investigational medicines continues to expand, supporting our goal to address critical gaps in treatment options for patients with cancers of high unmet need, says Peter C. Adamson, Global Development Head, Oncology at Sanofi. We look forward to presenting the latest data across our oncology portfolio and pipeline in four key areas multiple myeloma, skin cancers, lung cancers and breast cancer, including data supporting the potential for amcenestrant to become a best-in-class oral endocrine backbone therapy. Early clinical data for amcenestrant, our investigational oral selective estrogen receptor degrader (SERD), show potential to become a new endocrine backbone therapy in ER+ HER2- breast cancer* Source: West Corporation May 03, 2021: Banco Santander Annual General Meeting of April 30, 2021 Board composition: renewals, ratification of a co-opting Director and appointment of one new Director Source: West Corporation Changes in Board (TTM) 2022 Feb 28, 2022: Banco Santander appoints Independent Director Banco Santander has appointed Emile Voest as Independent Director. The effective date is Monday, February 28. Feb 22, 2022: Banco Santander appoints Independent Director Banco Santander has appointed Antoine Yver as Independent Director. The effective date is Tuesday, February 22. Feb 22, 2022: Banco Santander appoints Independent Director Banco Santander has appointed Carole Ferrand as Independent Director. The effective date is Tuesday, February 22. |