SNYNF Sanofi (PK)

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 6-K

REPORT OF FOREIGN PRIVATE ISSUER

PURSUANT TO RULE 13a-16 OR 15d-16

UNDER THE SECURITIES EXCHANGE ACT OF 1934

For the month of September 2023

Commission File Number: 001-31368

SANOFI

(Translation of registrant’s name into English)

46, avenue de la Grande Armée, 75017 Paris, FRANCE

(Address of principal executive offices)

Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.

Form 20-F ☒   Form 40-F ☐

In September 2023, Sanofi published the press release attached hereto as Exhibits 99.1, 99.2 and 99.3 which are incorporated herein by reference.

Exhibit Index

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

Exhibit 99.1

Press Release

Sanofi supporting vulnerable communities as part of commitment to social impact and fight against climate change

Paris, September 19, 2023 – As global leaders gather at the United Nations’ 78^th General Assembly, Sanofi is delivering vital support to communities beset by climate turbulence and by unmet medical needs. These critical initiatives come as the global healthcare company confirms its commitment to positively impact society by tackling climate change and its consequences for human health.

Ramping up adaptation efforts and initiatives to address the impact of climate change on the health of vulnerable communities becomes increasingly critical. Through Foundation S, Sanofi’s philanthropic organization, the company is strengthening locally led adaptation and health resilience programs for vulnerable communities impacted by climate change. Foundation S is today pledging nearly EUR 40 million through 2030 to support these efforts.

Paul Hudson

Chief Executive Officer, Sanofi

“Since 2015 and COP21, where Sanofi was the first and only pharmaceutical company discussing climate change and its impact on human health, we have been making strides to reduce the emissions of our supply chain and minimize the impact our products have on the environment. As we build our road to carbon neutrality by 2030, we also want to help address the broader impacts of climate change on the health of populations by teaming up with all stakeholders. By working with governments, health professionals, patient groups, regulators we can accelerate the decarbonization of healthcare systems, and by expanding our investments in the development of adaptation solutions for climate vulnerable communities. All our company commitments are rooted in concrete, transparent actions and driven by the greater sense of responsibility of playing our part in the global adaptation and fight against climate change.”

Sanofi starts in its own ‘climate’ backyard

In line with its objective to get to carbon neutrality by 2030, Sanofi is advancing a holistic, company-wide ambition to minimize the environmental impact of its products and activities, across its value chain, while strengthening resilience to environmental changes. To support its strategy, Sanofi plans to invest over EUR 450 million through 2030. These investments notably support company programs on energy efficiency and decarbonization of energy supplies, as well as resource circularity - reduce, reuse, recycle and recover - and reduction of natural resource extraction for water for instance.

Committed to the United Nation’s Race to Zero initiative, the company is building the road to carbon neutrality across all scopes of emissions by 2030, and net zero greenhouse gas emissions by 2045, five years earlier than previous targets. By the end of 2022, greenhouse gas emission had decreased 29% compared to 2019 in scopes 1 & 2 and by 7% in scope 3. In addition, the company has taken an end-to-end approach to reduce the environmental footprint of its products. For example, by 2027, the use of plastic in blister packs for all vaccines will be eliminated. Today, the company is at 33%. Also, 62% of electricity supplied on corporate sites is renewable with a target of 100% by 2030. Sanofi’s latest state-of-the-art facilities, such as its Evolutive Facilities of Neuville-sur-Saône in southern France and in Singapore, both set to open in 2025, are carbon-neutral by design, with zero landfilling and 100% of the waste recycled or recovered.

Several pilot programs have also been conducted to assess how Sanofi’s most innovative products can contribute to reducing emissions along the care pathway. The programs, evaluating medicines and vaccines for RSV, atopic dermatitis, and flu, show that prevention, reduced

hospitalizations, decreased outpatient visits and fewer patient consultations have a positive impact on CO₂ emissions while improving patients’ health outcome. Additionally, a pilot program on the benefits of utilizing telemedicine for patients with atopic dermatitis showed reduced CO₂ emission attributed to less frequent healthcare professionals’ visits while also improving patient comfort and outcomes. Sanofi will continue to implement pilot programs to advance data and understanding of the co-benefits of best-in-class therapies that can improve health outcomes while reducing greenhouse gas emissions.

Josep Catllà

Head of Corporate Affairs, Sanofi

“Sustainability is at the core of Sanofi’s long-term strategy, and it is ingrained in our mindset and behaviors in everything we do. Whether it’s about accelerating our environmental commitments, improving access to healthcare for vulnerable populations, or building a diverse, equitable and inclusive workplace, we’re driven by the ambition to make a sustainable positive impact for our people, our communities and society overall. This is why we are taking the initiative to help communities around the world to work towards the decarbonization of healthcare systems, which today account for more carbon emissions than air transport. By working with local governments and healthcare actors to significantly reduce those emissions, and by continuing our essential work in delivering first- and best-in-class medicines and vaccines, we double our impact to make our planet healthier.”

Joining forces to go one step further

Beyond reducing emissions from operations and its supply chain, Sanofi is focused on decarbonization of healthcare systems and sustainable delivery of care. The healthcare sector is responsible for 5% of total net emissions and the patient care pathway accounts for over 40% of that total. Sanofi is a leading member of the SMI Health Systems Taskforce, a public and private partnership of healthcare leaders launched at COP26, with an ambition to accelerate delivery of net zero, patient centric health systems. Sanofi is currently leading several key initiatives, notably the Patient Care Pathway group, focused on establishing an international measurement framework to calculate the carbon emissions of the patient care journey, the development of an industry product Life-Cycle-Assessment framework and a tool to measure the impact of pharmaceutical products on climate.

Sanofi @ United Nations General Assembly

Sanofi will host side events at the 78^th UN General Assembly, on September 20.

Sanofi’s Foundation S, in partnership with Foreign Policy and Africa Europe Foundation will host Time to Adapt: Accelerating Climate Adaptation for Health, a high-level strategic dialogue to spotlight the health impacts of climate change and to mobilize on the financial need required to support community-led climate adaptation efforts in low- and –middle-income countries. Despite contributing the least to climate change, low- and middle-income countries (LMICs) are most affected by its consequences, including increased morbidity and mortality, loss of livelihoods, and forced migration.

As part of its work, Foundation S has launched several first-in-class grant programs to enhance the capacity of communities to prepare for and respond to climate-related impacts on health. To further raise awareness about the need for and importance of strengthening and funding climate adaptation and health resilience initiatives at the local level in climate vulnerable countries, the Collective MindS think thank will publish on September 20, 2023 an Action Report that highlights adaptation solutions that can be replicated and brought to scale, and will call for urgent multi-lateral action to address the health impacts of climate change at the community level.

Sanofi’s Global Health Unit side event ‘Unlocking Universal Health Coverage 2030: The Power of Health Financing’, co-organized with the Health Finance Institute (HFI), will focus on mobilizing stakeholders on the need for financial sustainability, sufficiency, and tools for better access to healthcare, while sharing Sanofi’s Global Health Unit Model. HFI will present the conclusions of research supported by Sanofi on healthcare financing and highlight that focus on higher efficiency and collaboration among different actors is key.

About Sanofi

We 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

Media Relations

Sandrine Guendoul | + 33 6 25 09 14 25 | sandrine.guendoul@sanofi.com

Evan Berland | +1 215 432 0234 | evan.berland@sanofi.com

Victor Rouault | + 33 6 70 93 71 40 | victor.rouault@sanofi.com

Investor Relations

Eva Schaefer-Jansen | + 33 7 86 80 56 39 | eva.schaefer-jansen@sanofi.com

Arnaud Delépine | + 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

Tarik Elgoutni| + 1 617 710 3587 | tarik.elgoutni@sanofi.com

Nathalie 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 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 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 Sanofi’s 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.

Exhibit 99.2

Press Release

Once-weekly ALTUVIIIO^® approved in Japan as a new class of factor VIII therapy for hemophilia A

Paris, September 25, 2023. The Japanese Ministry of Health, Labor, and Welfare (MHLW) has granted marketing authorization for ALTUVIIIO^®[Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein], a first-in-class, high-sustained factor VIII replacement therapy. ALTUVIIIO is indicated for control of bleeding tendency in patients with hemophilia A (factor VIII deficiency). ALTUVIIIO was also recently approved by the Taiwan Food and Drug Administration for treatment of adults and children with hemophilia A on August 31, 2023.

Also referred to as efanesoctocog alfa, 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 in adults and adolescents, and significantly reduces bleeds compared to prior factor VIII prophylaxis in adults and adolescents with severe hemophilia A. ALTUVIIIO can be used 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.

Brian Foard

Executive Vice President, Global Head of Specialty Care ad interim, Sanofi

“The approval of ALTUVIIIO in Japan and Taiwan represents a major step forward for people living with hemophilia A in those countries. The high-sustained factor activity levels will enable patients and physicians to reimagine living with hemophilia. ALTUVIIIO is a testament to Sanofi’s promise to deliver first-in-class best-in-class therapies that can redefine the treatment paradigm and transform the standard of care for people around the world living with hemophilia.”

Hemophilia A is a rare, lifelong condition in which the ability of a person’s 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 person’s blood, and there is a negative correlation between risk of bleeding and factor activity levels.

The MHLW approval is based on positive data from patients with severe hemophilia A, including the pivotal XTEND-1 trial in adults and adolescents and data from the XTEND-Kids trial in children under 12 years of age. In the XTEND-1 study, once-weekly ALTUVIIIO prophylaxis (50 IU/kg) met the primary endpoint, providing significant bleed protection for people with severe hemophilia A with a mean annualized bleeding rate (ABR) of 0.71 (95% CI: 0.52 - 0.97) and a median ABR of 0.00 (Q1, Q3: 0.00, 1.04). ALTUVIIIO met the key secondary endpoint with a significant reduction of 77% in ABR versus prior factor VIII prophylaxis based on an intra-patient comparison (95% CI: 58%, 87%).

Data from XTEND-Kids, showed that children younger than 12 years of age receiving once-weekly ALTUVIIIO (50 IU/kg) for 52 weeks (n=73) experienced a mean ABR of 0.6 (95% CI: 0.4 - 0.9) and a median ABR of 0 (Q1, Q3: 0.0 - 1.0). Safety results were consistent with data from the XTEND-1 trial.

Across these 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 was first approved in February 2023 by the US Food and Drug Administration. The FDA previously granted Breakthrough Therapy designation in May 2022 — the first factor VIII therapy to receive this designation — Fast Track designation in 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.

About ALTUVIIIO^®

ALTUVIIIO [Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein] 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 for most of the week, allowing for once-weekly administration. 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 Sanofi and Sobi collaboration

Sobi 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 Sobi^®

Sobi 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. Sobi’s share (STO:SOBI) is listed on Nasdaq Stockholm. More about Sobi at sobi.com, LinkedIn and YouTube.

About Sanofi

We 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

Media Relations

Sandrine Guendoul | + 33 6 25 09 14 25 | sandrine.guendoul@sanofi.com

Sally Bain | + 1 617 834 6026 | sally.bain@sanofi.com

Evan Berland | +1 215 432 0234 | evan.berland@sanofi.com

Victor Rouault | + 33 6 70 93 71 40 | victor.rouault@sanofi.com

Investor Relations

Eva Schaefer-Jansen | + 33 7 86 80 56 39 | eva.schaefer-jansen@sanofi.com

Arnaud Delépine | + 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

Tarik Elgoutni| + 1 617 710 3587 | tarik.elgoutni@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 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 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 Sanofi’s 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.

Exhibit 99.3

Press Release

Dupixent^® (dupilumab) sBLA for treatment of eosinophilic esophagitis in children aged 1 to 11 accepted for FDA Priority Review

Paris and Tarrytown, N.Y. September 26, 2023. The U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent^® (dupilumab) to treat children aged 1 to 11 years with eosinophilic esophagitis (EoE). The target action date for the FDA decision is January 31, 2024. Dupixent is the first and only treatment in the U.S. approved for children and adults aged 12 years and older with EoE, weighing at least 40kg.

The sBLA is supported by data from the Phase 3 EoE KIDS trial (Parts A and B) evaluating the efficacy and safety of Dupixent in children aged 1 to 11 with EoE. In Part A, the primary endpoint was met for the proportion of patients achieving histological disease remission (defined as peak esophageal intraepithelial eosinophil count of ≤6 eosinophils [eos]/high power field [hpf]) at 16 weeks for tiered dosing regimens based on body weight, compared to placebo. Part B was an active treatment extension period evaluating Dupixent for an additional 36 weeks and showed Dupixent maintained histologic remission for 52 weeks, a secondary endpoint. Dupixent also led to increases in body weight for age percentile, which was evaluated as an exploratory endpoint in Part A and a secondary endpoint in Part B.

Safety results in Parts A and B of the trial were generally consistent with the known safety profile of Dupixent in its FDA-approved EoE indication for children and adults aged 12 years and older who weigh at least 40 kg. Adverse events more commonly observed (≥5%) with Dupixent were COVID-19, rash, headache, viral gastroenteritis, diarrhea and nausea.

Priority review is granted to therapies that have the potential to provide significant improvements in the treatment, diagnosis or prevention of serious conditions.

The potential use of Dupixent in children with EoE aged 1 to 11 years is currently under clinical development, and its safety and efficacy have not been fully evaluated by any regulatory authority in this setting.

About Eosinophilic Esophagitis

EoE is a chronic, progressive disease driven by type 2 inflammation that damages the esophagus and prevents it from working properly. In children, common symptoms of EoE include heart burn, vomiting, abdominal discomfort, trouble swallowing, food refusal and failure to thrive. These symptoms can impact growth and development and can cause food-related fear and anxiety, which can persist through adulthood. Dietary adjustments, including the elimination of many foods, are 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. Continuous treatment of EoE may be needed to reduce the risk of complications and disease recurrence.

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), 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 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, Regeneron and Sanofi 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 Regeneron

Regeneron 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, Regeneron’s 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 Regeneron’s laboratories. Regeneron’s 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 its 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 Regeneron, please visit www.regeneron.com or follow Regeneron on LinkedIn.

About Sanofi

We 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

Sanofi Media Relations

Sally Bain | + 1 617 834 6026 | sally.bain@sanofi.com

Evan Berland | +1 215 432 0234 | evan.berland@sanofi.com

Victor Rouault | + 33 6 70 93 71 40 | victor.rouault@sanofi.com

Sanofi Investor Relations

Eva Schaefer-Jansen | + 33 7 86 80 56 39 | eva.schaefer-jansen@sanofi.com

Arnaud Delépine | + 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

Tarik Elgoutni | + 1 617 710 3587 | tarik.elgoutni@sanofi.com

Nathalie Pham | + 33 07 85 93 30 17 | nathalie.pham@sanofi.com

Regeneron Media Relations

Sharon Chen | +1 914-847-1546| sharon.chen@regeneron.com

Regeneron Investor Relations

Vesna 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 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 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 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 Sanofi’s 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, “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 children aged 1 to 11 years with eosinophilic esophagitis (“EoE”); 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 as Dupixent for the treatment of children aged 1 to 11 years with EoE (including potential approval by the U.S. Food and Drug Administration based on the supplemental Biologics License Application discussed in this press release), 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 Regeneron’s Products 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 or any potential regulatory approval of Regeneron’s Products (such as Dupixent) and Regeneron’s Product Candidates; 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; 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 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 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 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 June 30, 2023. 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 (https://investor.regeneron.com) and its LinkedIn page (https://www.linkedin.com/company/regeneron-pharmaceuticals).