6-K

Dated: May 2, 2024

/s/ Alexandra Roger

Name: Alexandra Roger

Title: Head of Legal Corporate & Finance

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 May 2024

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 April and in May 2024, 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 April 17, 2024: New 48-week frexalimab phase 2 data support potential for high sustained efficacy in multiple sclerosis

Exhibit 99.2		Press Release dated April 23, 2024: Rilzabrutinib LUNA 3 phase 3 study met primary endpoint in immune thrombocytopenia

Exhibit 99.3		Press Release dated April 30, 2024: Annual General Meeting of April 30, 2024

Exhibit 99.4		Press Release dated May 2, 2024: Beyfortus real-world evidence published in The Lancet shows 82% reduction in infant RSV hospitalizations

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.

EX-99.1

Exhibit 99.1


Press Release

New 48-week frexalimab phase 2 data support potential for high sustained efficacy in multiple sclerosis

Data support frexalimab as a potential first-in-class, high-efficacy, non-lymphocyte depleting treatment for relapsing multiple sclerosis

96% of participants receiving high-dose intravenous frexalimab had no new Gd+ T1 lesions and an annualized relapse rate of 0.04 after 48 weeks

Sanofi has initiated global phase 3 studies of frexalimab in relapsing MS and non-relapsing secondary progressive MS

Paris, April 17, 2024. Sanofi’s CD40L antibody, frexalimab, demonstrated sustained reduction of disease activity and favorable tolerability after nearly one year in participants with relapsing multiple sclerosis. These data will be presented today at the American Academy of Neurology (AAN) 2024 Annual Meeting in Denver, Colorado, US. Results from the 12-week double-blind study period were previously published in The New England Journal of Medicine.

Patrick Vermersch, MD, PhD

University of Lille, CHU Lille, France

“These 48-week data showed that treatment with frexalimab resulted in further decreases in the number of lesions and a sustained reduction in disease activity. The preliminary clinical results are promising with a very low annual relapse rate. This strengthens the rationale for targeting CD40L in MS and supports further development of frexalimab as a potential high-efficacy therapy in relapsing MS.”

From the initial 12-week double-blind period, 97% (125/129) of study participants entered the open-label extension (OLE) of the phase 2 study. Of all participants receiving frexalimab, both on high- and low-dose regimens and participants who switched from placebo at the start of the open-label extension period (week 12), 87% (112/129) remained in the study at the 48-week cut-off. During the OLE, participants in the high- (n=50) and low-dose (n=49) arms continued to receive frexalimab 1200 mg intravenously every four weeks, or frexalimab 300 mg subcutaneously every two weeks, respectively, while those initially receiving placebo switched to the aforementioned high or low dose frexalimab treatment arms (n=12 and n=14, respectively).

Erik Wallström, MD, PhD

Global Head of Neurology Development, Sanofi

“Frexalimab represents a novel potential first-in-class treatment mechanism in multiple sclerosis designed to tackle the aspects of this disease where unmet medical needs still exist. We are applying our deep expertise to address the full spectrum of neuroinflammation and neurodegeneration to improve the lives of people living with multiple sclerosis.”

Results of the phase 2 OLE at week 48 showed:

●

96% of patients who continued receiving high-dose frexalimab and 87% of those who continued receiving low-dose frexalimab were free of Gd+ T1 lesions at week 48, respectively. Additionally, among patients who switched from placebo to high and low-dose frexalimab at the start of the OLE at week 12, declines were seen at Week 24, and 90% and 92% were free of Gd+ T1 lesions at week 48, respectively.

●

The number of Gd+ T1-lesions (mean [SD]) remained low in participants who continued receiving frexalimab (high dose: 0.0 [0.2]; low dose: 0.2 [0.5]) and continued to decline in those who switched from placebo to frexalimab at week 12 (high dose: 0.2 [0.6]; low dose: 0.1 [0.3]).


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●

Number of and volume change of new or enlarging Gd+ T2-lesions remained low for all frexalimab treatment groups through week 48, and lymphocyte counts remained stable.

●

Participants who continued receiving high-dose frexalimab experienced a low annualized relapse rate (ARR) of 0.04 (95% CI: 0.01, 0.18) over the 48-week treatment period with 96% being free of relapses. ARR in the initial low-dose arm was 0.22, and ARR in patients who switched to high and low-dose frexalimab were 0.09 and 0.40, respectively, through week 48.

Frexalimab was generally well-tolerated through week 48. The most common adverse events (≥10%) amongst all subgroups of patients receiving frexalimab during OLE until cut-off at week 48 from baseline were nasopharyngitis (n=14 [11%]), headache (n=14 [11%]) and COVID-19 (n=13 [10%]).

About the phase 2 study

The phase 2 study was a randomized, double-blind, placebo-controlled study evaluating frexalimab in participants with relapsing MS. Participants were randomized (4:4:1:1) to receive either high (frexalimab 1200 mg intravenously every four weeks, with an initial 1800 mg loading dose) or low (frexalimab 300 mg subcutaneously every two weeks, with an initial 600 mg loading dose) doses of frexalimab or matching placebo for 12 weeks (Part A). The primary endpoint was the reduction in the number of new Gd+ 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 first-in-class 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 studies for Multiple Sclerosis and phase 2 clinical studies for immunology indications 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 people’s lives. Our team, across the world, 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

Victor Rouault | +3333 6 70 93 71 40 | victor.rouault@sanofi.com

Timothy Gilbert |+ 1 516 521 2929 | timothy.gilbert@sanofi.com

Investor Relations

Thomas Kudsk Larsen | +44 7545 513 693 | thomas.larsen@sanofi.com

Alizé Kaisserian | + 33 6 47 04 12 11 | alize.kaisserian@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

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

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

Sanofi Forward-Looking Statements


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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, 2023. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.


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EX-99.2

Exhibit 99.2


Press Release

Rilzabrutinib LUNA 3 phase 3 study met primary endpoint in immune thrombocytopenia

●

Pivotal data from the first phase 3 study of a BTKi in immune thrombocytopenia (ITP) underscore the potential of rilzabrutinib to provide a clinically meaningful benefit to patients living with ITP

●

Regulatory submissions in the US and EU anticipated by year-end

●

Rilzabrutinib is one of 12 potential medicines and vaccines in Sanofi’s robust immunology pipeline and a testament to Sanofi’s ability to successfully accelerate and build a portfolio of next-generation transformative treatments for immune diseases

●

In addition to ITP, rilzabrutinib is being studied across a variety of immune-mediated diseases including asthma, chronic spontaneous urticaria, prurigo nodularis, IgG4-related disease and warm autoimmune hemolytic anemia

Paris, April 23, 2024. Positive results from the LUNA 3 phase 3 study demonstrated that rilzabrutinib 400 mg twice daily orally achieved the primary endpoint of durable platelet response in adult patients with persistent or chronic immune thrombocytopenia (ITP). The safety profile of rilzabrutinib was consistent with that reported in previous studies.

LUNA 3 study met its primary endpoint demonstrating a significantly higher proportion of patients receiving rilzabrutinib achieved the primary endpoint of durable platelet response versus placebo. This clinically and statistically significant result was achieved in a population of patients with primary ITP that had been refractory to prior therapy. Overall, study participants had a median of four prior ITP therapies and a median baseline platelet count of 15,000/µL (normal platelet count levels typically range from 150,000-450,000/µL). Positive results on key secondary endpoints also underscore the potential for rilzabrutinib to deliver clinically meaningful benefits for patients living with persistent and chronic ITP.

Rilzabrutinib was granted Fast Track Designation by the US Food and Drug Administration (FDA) for the treatment of ITP in November 2020 and was previously granted Orphan Drug Designation.

Houman Ashrafian

Executive Vice President, Head of Research and Development, Sanofi

“The results of this study reinforce rilzabrutinib’s potential to be a first-in-class oral, reversible BTK inhibitor that can provide clinically meaningful improvements for people living with severe immune-mediated diseases like ITP. These pivotal results are a testament to our commitment and expertise in rare blood diseases and ability to build a portfolio of next-generation small-molecule inhibitors that are both more selective and optimized to deliver robust efficacy and safety outcomes as compared to existing therapies.”

ITP is a serious, acquired autoimmune blood disorder characterized by autoantibody-mediated platelet destruction and impaired platelet production, leading to thrombocytopenia (low platelet counts of less than 100,000/µL) and an increased risk of life-threatening bleeding episodes (like intracranial hemorrhage). In addition, patients with ITP often experience significant quality-of-life impairments such as fatigue and cognitive dysfunction. With its dual mechanisms of action that reduce production of pathogenic autoantibodies and decrease macrophage mediated platelet destruction, rilzabrutinib could address the underlying mechanisms responsible for a wide range of ITP complications.

About LUNA 3

LUNA 3 (NCT04562766) is a randomized, multicenter, phase 3 study evaluating the efficacy and safety of rilzabrutinib vs placebo in adult and adolescent patients with persistent or chronic ITP.


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Patients received either oral rilzabrutinib 400 mg twice a day or placebo through a 12-to 24-week double-blind treatment period, followed by a 28-week open-label treatment, and then a 4-week safety follow-up or long-term extension period. The adolescent part of the study is ongoing and still recruiting.

The primary endpoint is durable platelet response defined as the proportion of participants able to achieve platelet counts at or above 50,000/µL for for at least 8 out of the last 12 weeks of the 24-week blinded treatment period in the absence of rescue therapy. Secondary endpoints include the number of weeks with and time to platelet responses, rescue therapy use, and physical fatigue and bleeding score.

Detailed results of the LUNA 3 phase 3 study will be presented at a medical congress later this year.

Rilzabrutinib is currently under clinical investigation, and its safety and efficacy have not been evaluated by any regulatory authority.

About Rilzabrutinib

Rilzabrutinib is an oral, reversible, covalent BTK inhibitor that has the potential to be a first- or best-in-class treatment of several immune-mediated diseases. BTK, expressed in B cells, mast cells and other cells from the innate immune system, plays a critical role in inflammatory pathways and multiple immune-mediated disease processes. With the application of Sanofi’s TAILORED COVALENCY^® technology, rilzabrutinib can selectively inhibit the BTK target.

Rilzabrutinib is being studied across a variety of immune-mediated diseases, including immune thrombocytopenia (regulatory submission in H2 2024), asthma (phase 2), chronic spontaneous urticaria (phase 3 start in 2024), prurigo nodularis (phase 3 start in 2024), IgG4-related disease (phase 2b results in H2 2024), and warm autoimmune hemolytic anemia (phase 2b results in H2 2024).

About Sanofi

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

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

Timothy Gilbert | + 1 516 521 2929 | timothy.gilbert@sanofi.com

Investor Relations

Thomas Kudsk Larsen |+ 44 7545 513 693 | thomas.larsen@sanofi.com

Alizé Kaisserian | + 33 6 47 04 12 11 | alize.kaisserian@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


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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, 2023. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.


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EX-99.3

Exhibit 99.3


Press Release

Annual General Meeting of April 30, 2024

•

Approval of the financial statements for the fiscal year 2023

•

Distribution of a cash dividend of €3.76 per share, with payment as of May 15, 2024

•

Board composition: renewal of two Directors and appointment of three new Independent Directors

Paris, April 30, 2024. The Combined General Shareholders’ Meeting of Sanofi was held on April 30, 2024, under the chairmanship of Frédéric Oudéa. 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 2023 and decided on the distribution of an ordinary annual dividend of €3.76 per share. The payment of the dividend will be made on May 15, 2024.

The General Meeting also renewed Rachel Duan and Lise Kingo as Directors, and approved the appointment of Clotilde Delbos, Anne-Françoise Nesmes and John Sundy, all being qualified as independent Directors.

On the proposal of the Appointments, Governance and CSR Committee, the Board of Directors has appointed Clotilde Delbos as member of the Audit and Compensation Committees, Anne-Françoise Nesmes as member of the Audit Committee and John Sundy as member of the Scientific Committee. Carole Ferrand succeeds Fabienne Lecorvaisier as head of the Audit Committee, who will remain a member of the Committee for the last year of her term. Antoine Yver becomes Chair of the Scientific Committee and a member of the Strategy Review Committee.

Following the General Meeting, the Board of Directors is temporarily composed of 17 Directors, including two directors representing employees. It has an independence rate of 80% and a gender diversity rate of 47%. It also has 8 directors of foreign nationality, i.e. a rate of 47 %.

The voting results and the videocast of the Annual General Meeting are available here.

About Sanofi

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

Investor Relations

Thomas Kudsk Larsen |+ 44 7545 513 693 | thomas.larsen@sanofi.com

Alizé Kaisserian | + 33 6 47 04 12 11 | alize.kaisserian@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


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EX-99.4

Exhibit 99.4


Press Release

Beyfortus real-world evidence published in The Lancet shows 82% reduction in infant RSV hospitalizations

•

New real-world evidence shows Beyfortus (nirsevimab) substantially reduced RSV lower respiratory tract disease and hospitalizations in infants during the 2023-2024 RSV season, versus no intervention^1-6

•

Results add to the consistent high efficacy of Beyfortus against medically attended RSV lower respiratory tract disease, shown in the pivotal clinical studies and the outcomes from HARMONIE, a phase 3b clinical study conducted in close to real-life conditions^7-10

Paris, May 2, 2024. Beyfortus reduced respiratory syncytial virus (RSV) hospitalizations by 82% (95% CI: 65.6 to 90.2) in infants under 6 months of age, compared to infants who received no RSV intervention, according to the interim results of an ongoing study published in The Lancet. These results, from the first RSV season after Beyfortus’ introduction, are part of the three-year NIRSE-GAL study conducted in Galicia, Spain under a collaborative framework with the Galician Directorate of Public Health of the Xunta de Galicia (Galician government) and Sanofi.¹

The results echo real-world evidence (RWE) reported from several broad infant immunization programs across the US, Spain and France during the 2023-2024 RSV season, which add to the consistent and high efficacy seen in pivotal clinical studies with Beyfortus. Real-world evidence demonstrates if a treatment or immunization is effective in day-to-day practice, as opposed to “efficacy” determined in carefully controlled clinical trials. A favorable safety profile was observed following Beyfortus use, consistent with clinical study results.^1-10

Federico Martinon Torres

Head of Pediatrics, Hospital Clínico Universitario Santiago, Spain and principal investigator of NIRSE-GAL study

“Galicia provides the first population-based real-world evidence of the impact of nirsevimab to prevent RSV disease in infants, showing a reduction by almost 90% in the number of hospitalizations due to this virus when compared with several previous RSV seasons. This achievement is the result of the exemplary pragmatic collaboration among scientists, industry, healthcare providers and policy makers aligned with a carefully planned roll-out of the immunization campaign, and the outstanding response of the Galician parents to this prophylaxis campaign.”

Thomas Triomphe

Executive Vice President, Vaccines, Sanofi

“The scale and speed of impact seen after Beyfortus’ introduction demonstrates the strength of all-infant immunization strategies against RSV in babies. In Galicia, we saw an effectiveness of 82% in reducing RSV hospitalizations following the launch of Beyfortus, with more than 90% of eligible infants immunized. A growing body of evidence from these programs support policymakers, healthcare providers and parents who share our collective ambition to safeguard babies from RSV disease.”

NIRSE-GAL is a large, population-based, three-year follow-up study to evaluate the effectiveness of Beyfortus following its inclusion in the Galician immunization schedule. The study aims to measure the impact of Beyfortus on hospitalizations due to RSV, all-cause lower respiratory tract disease, severe lower respiratory tract disease caused by RSV, all-cause lower respiratory tract disease hospitalizations, and all-cause hospitalizations among infants born during the RSV season, infants under 6 months of age at the start of the season, and children aged 6-24 months who are vulnerable to severe RSV disease at the start of the season. The 2023-2024 immunization campaign ran from September 25, 2023 to March 31, 2024.¹

RWE from countries with Beyfortus all-infant immunization programs in 2023-24

In addition to this new effectiveness study, evidence of the high impact following Beyfortus’ introduction has been consistently shown in several other real-world studies.

●

An interim analysis of 2023-24 surveillance data published in the US Centers for Disease Control and Prevention’s (CDC) Morbidity and Mortality Weekly Report (MMWR) shows a single dose of Beyfortus was 90% effective in preventing hospitalizations due to RSV in babies who were immunized below 8 months of age.²

●

A recent draft recommendation from Haute Autorité de Santé in France reported, across six hospitals, an effectiveness of 83% against RSV-associated hospitalization in infants who received Beyfortus compared to those with no intervention.³

●

In Catalonia, Spain, a study pre-printed in The Lancet showed reductions of 87.6% and 90.1% in hospital and ICU admissions for RSV, respectively, among babies born before the start of the RSV season, who were eligible to receive Beyfortus, compared to those with no intervention.⁴

●

A pooled analysis of data from three Spanish regions, including Valencia, Murcia, and Valladolid, showed an 84.4% effectiveness in preventing hospitalizations due to RSV in infants under 9 months of age versus infants who received no intervention. The results were published in Eurosurveillance.⁵

●

A study from Navarra, Spain published in Vaccines found an effectiveness of 88.7% in preventing hospitalizations among infants immunized at birth with Beyfortus, compared to no intervention.⁶

The expansion of the Beyfortus manufacturing network is progressing well and according to plan. This expansion will allow Sanofi and AstraZeneca to more than triple manufacturing capacity. Based on this, and assuming regulatory validations are delivered in due time by regulatory agencies, Sanofi and AstraZeneca are confident to meet global commitments and build inventory that can be used in future RSV seasons. In addition, the companies are producing Beyfortus well in advance of the RSV season, with the vast majority of doses planned to be available by October.

About RSV

RSV is a highly contagious virus that can lead to serious respiratory illness for infants.¹¹ 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.^11,12 RSV is the most common cause of lower respiratory tract disease, including bronchiolitis and pneumonia, in infants.¹³ It is also a leading cause of hospitalization in infants worldwide, 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 3 million hospitalizations, and it was estimated that there were 26,300 in-hospital deaths of children younger than 5 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 (nirsevimab) is the first immunization designed for all infants for protection against RSV 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 designed to protect 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. Beyfortus administration can be timed to coincide with 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 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 US where Sanofi consolidates 100% of the economic benefits in its Business Operating Income.

Beyfortus has been approved for use in the European Union, the US, China, Japan, and many other countries around the world. Special designations to facilitate expedited development of Beyfortus were granted by several regulatory agencies, including Breakthrough Therapy Designation and Priority Review designation by The China Center for Drug Evaluation under the National Medical Products Administration; Breakthrough Therapy Designation and Fast Track Designation from the US 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 Beyfortus 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.

About Sanofi

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

Thomas Kudsk Larsen |+ 44 7545 513 693 | thomas.larsen@sanofi.com

Alizé Kaisserian | + 33 6 47 04 12 11 | alize.kaisserian@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, 2023. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

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