6-K

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 June 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  ☐

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):                 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):                 

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In June 2023, Sanofi published the press releases attached hereto as Exhibits 99.1, 99.2, 99.3 and 99.4 which are incorporated herein by reference.

Exhibit Index

Exhibit No.	Description
Exhibit 99.1	Press Release dated June 8, 2023: FDA Advisory Committee unanimously recommends nirsevimab as first immunization against RSV disease for all infants
Exhibit 99.2	Press Release dated June 13, 2023: Sanofi “all in” on artificial intelligence and data science to speed breakthroughs for patients
Exhibit 99.3	Press Release dated June 14, 2023: Sanofi Consumer Healthcare launches new portal to unlock science and solve key challenges in self-care
Exhibit 99.4	Press Release dated June 20, 2023: Sanofi prevails in Zantac arbitration initiated by Boehringer Ingelheim

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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.

Dated: June 20, 2023	SANOFI
	By	/s/ Alexandra Roger
		Name: Alexandra Roger
		Title: Head of Securities Law and Capital Markets

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EX-99.1

Exhibit 99.1

  Press Release

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 approved

☐ Across all clinical trials, a single dose of nirsevimab delivered high, consistent and sustained efficacy and favorable safety against RSV disease

☐ The 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 AstraZeneca’s 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 nirsevimab’s 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, Sanofi

“Most 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 Committee’s positive vote based on the compelling clinical development program supporting nirsevimab and its breakthrough potential to reduce the magnitude of annual RSV burden.”

Iskra Reic

Executive Vice President, Vaccines and Immune Therapies, AstraZeneca

“We 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 AstraZeneca’s 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 Muller

Associate Professor, Pediatrics, Northwestern University Feinberg School of Medicine and Scientific Director, Clinical and Community Trials, Ann & Robert H. Lurie Children’s 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.

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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 AMDAC’s recommendation, while not binding, will be considered by the FDA during its review of the BLA for nirsevimab.

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). 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 nirsevimab

In 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 Designation from 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.

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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 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

Nicolas 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.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

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

Felix Lauscher | + 1 908 612 7239 | felix.lauscher@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.

References

1. Centers for Disease Control and Prevention. RSV in Infants and Young Children. October 28, 2022. https://www.cdc.gov/rsv/high-risk/infants-young-children.html. Accessed June 2023.

2. Walsh, EE. Respiratory Syncytial Virus infection: an illness for all ages. Clin Chest Med. 2017; 38(1):29-36.

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3. 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.

4. Zhou H, et al. Clin Infect Dis. 2012;54:1427–1436.

5. 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.

6. 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.

7. Centers for Disease Control and Prevention. Vaccines & Immunizations. September 24, 2021. https://www.cdc.gov/vaccines/vac-gen/immunity-types.htm. Accessed June 2023.

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EX-99.2

Exhibit 99.2

  Press Release

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, Sanofi’s 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 Hudson

CEO, Sanofi

“Our 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 plai’s 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.

In Manufacturing and Supply, Sanofi is digitizing quality assessment processes, moving from paper to Electronic Batch Records, leveraging digital and data to improve asset utilization and increase productivity by implementing new manufacturing 4.0 capabilities. Sanofi has also developed an in-house AI-enabled yield optimization solution which learns from past and current batch performance to enable consistently higher yield levels. This helps to optimize usage of raw materials, contributing to the company’s 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.

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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 Exscientia’s AI-based capabilities and personalized medicine platform, Sanofi’s 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 Sanofi’s 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.

Sanofi’s 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 Sanofi’s 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 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

Nicolas Obrist | + 33 6 77 21 27 55 | nicolas.obrist@sanofi.com

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

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

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

Chrystel Baude | + 33 6 70 98 70 59 | chrystel.baude@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

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

Felix Lauscher | + 1 908 612 7239 | felix.lauscher@sanofi.com

Nathalie Pham | + 33 7 85 93 30 17 | nathalie.pham@sanofi.com

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EX-99.3

Exhibit 99.3

Press Release

Sanofi Consumer Healthcare launches new portal to unlock science and solve key challenges in self-care

Paris, France – June 14, 2023 – Sanofi’s Consumer Healthcare Business Unit has today launched a new Open Innovation Portal, allowing the wider supply chain community to submit their creative, disruptive, and game-changing solutions to meet the challenges of an ever-evolving consumer healthcare landscape. Startups, entrepreneurs, research institutions, accelerators, universities and more can now respond online to challenge areas that have been identified by Sanofi Consumer Healthcare, from creating sustainable packaging to developing new products and technologies.

The healthcare landscape is evolving rapidly and, post-COVID, with an ever-increasing recognition of the importance of self-care, self-diagnosis and self-treatment. The launch of the Sanofi Consumer Healthcare Open Innovation Portal will facilitate the commercialization of the very best self-care innovative solutions by uniting the boldest and brightest external ideas with Sanofi’s marketing expertise, science infrastructure, scale and consumer reach. 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 ideas.

Josephine Fubara

Chief Science Officer, Consumer Healthcare, Sanofi

“A problem shared is a problem halved and the Open Innovation Portal is part of our mission to unlock science to bring health in the hands of millions of consumers and patients. The Open Innovation Portal will also serve as an opportunity to partner with the brightest and the best to bring some truly transformative ideas to life for our consumers.”

Sanofi will continue to add new challenges to the Open Innovation Portal in the areas of digestive wellness, cough, cold & flu, physical & mental wellness, allergy, pain care, personal care and sustainability.

The Open Innovation Portal is part of its wider mission to unlock science to empower consumers to take health in their hands, while also meeting sustainability goals of achieving carbon neutrality, reducing waste, protecting ecosystems and increasing ingredient transparency.

Sanofi is also proud to partner with the VivaTech 2023 conference, taking place in Paris from 14-17 June. Anyone who is interested in learning more about the Open Innovation Portal and how it can help us to solve the biggest challenges in self-care can visit Sanofi at their stall to find out more.

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 | sandrine.guendoul@sanofi.com

Patricia Pascual | patricia.pascual@sanofi.com

EX-99.4

Exhibit 99.4

  Press Release

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 appealed

• Key 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 claims

• Sanofi 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 BI’s 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 Sanofi’s 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 Zantac’s 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 FDA’s 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 Sanofi’s Animal Health business for BI’s 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 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

Nicolas Obrist | + 33 6 77 21 27 55 | nicolas.obrist@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 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 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.