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 July 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 June 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 June 20, 2024: Sanofi and Biovac spearhead polio vaccine manufacturing capabilities in Africa
Exhibit 99.2		Press Release dated June 21, 2024: ISTH: Sanofi advances leadership in hemophilia with new data for ALTUVIIIO and fitusiran
Exhibit 99.3		Press Release dated June 21, 2024: Audrey Duval Derveloy appointed Global Head of Corporate Affairs, member of Sanofi’s Executive Committee
Exhibit 99.4		Press Release dated June 26, 2024: Dupixent positive phase 3 data in children one to 11 years of age with eosinophilic esophagitis published in NEJM

 

2

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: July 2, 2024						SANOFI
				By		/s/ Alexandra Roger
						Name: Alexandra Roger
						Title: Head of Legal Corporate & Finance

 

3

Exhibit 99.1

 

Press Release

Sanofi and Biovac spearhead polio vaccine manufacturing capabilities in Africa

Paris, June 20, 2024. Sanofi and Biovac, a Cape Town, South Africa-based biopharmaceutical company, announce today their local manufacturing partnership to produce inactivated polio vaccines (IPV) in Africa. This agreement is designed to enable regional manufacturing of polio vaccines to serve the potential needs of over 40 African countries. This partnership with Sanofi makes Biovac the first African producer of IPV on and for the African continent and supports the Africa Centers for Disease Control and Prevention’s ambition to have 60 percent of local vaccines produced in Africa by 2040.

Thomas Triomphe

Executive Vice President, Vaccines, Sanofi

“For 40 years, Sanofi has supplied billions of polio vaccine doses globally, supporting the world getting close to polio eradication. But with the COVID-19 pandemic, many routine pediatric vaccination programs were halted or disrupted. Catching up will be key to preventing a rise in cases in many countries worldwide and this Sanofi partnership with Biovac is a step in that direction. Establishing this manufacturing partnership now, ahead of time, is key to enabling Biovac’s manufacturing capabilities for future international tenders.”

Dr Morena Makhoana

Chief Executive Officer, Biovac

“We are very proud of this partnership with Sanofi, which will empower Biovac as an African manufacturer to champion polio eradication on and for the continent by bringing manufacturing of IPV doses closer to people needs.”

Sanofi has been a critical partner of the Global Polio Eradication Initiative since 1988 and has supplied the world and UNICEF with more than 1.5 billion doses of IPV through GAVI, the Vaccine Alliance, which aims to vaccinate the populations of more than 70 of the poorest countries on the planet with the aim to eradicate polio.

Sanofi will continue to produce the bulk of IPV and Biovac, who will hold the marketing authorization, will be responsible for late-stage formulation, filling, packaging, and delivery of millions of IPV doses to UNICEF for GAVI countries in Africa.

Biovac is a leading biotechnology company and a Centre of Excellence, rooted in Africa, specializing in the development and manufacture of vaccines and other biologicals for Africa and beyond. In collaboration with the South African government, Biovac was established in 2003 to revive local human vaccine development and manufacturing capability in Southern Africa.

Polio is a highly contagious disease which mainly affects children under five years of age, who suffer the highest burden of temporary or permanent paralysis and death. Polio is an incurable infection that can only be prevented through immunization. Infected individuals shed the polio virus in the environment through fecal matter, or through the droplets from a sneeze or cough of an infected person, for several weeks. Almost 90 percent of infected people have no symptoms or very mild symptoms that usually remain undetected. In others, initial symptoms include fever, fatigue, headache, vomiting, aching muscles, stiffness in the neck and pain in the limbs. One in 200 infections leads to irreversible paralysis.

Over the last 30 years, under the Global Polio Eradication Initiative (GPEI), 2.5 billion children have been immunized against polio resulting in a 99 percent reduction in the number of cases worldwide. At the end of 2023, polio was endemic in only two countries (Afghanistan and Pakistan). As a result of the global effort to eradicate the disease, almost 20 million people have been saved from paralysis.

 

				1/2

 

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

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

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

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

Keita Browne | + 1 781 249 1766 | keita.browne@sanofi.com

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

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

Thibaud Châtelet | + 33 6 80 80 89 90 | thibaud.chatelet@sanofi.com

 

 

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

 

				2/2

Exhibit 99.2

Internal

 

Press Release

ISTH: Sanofi advances leadership in hemophilia with new data for ALTUVIIIO and fitusiran

 

•

Seven oral presentations across the hemophilia portfolio reinforce Sanofi’s commitment to bring potential first- and best-in-class treatments to the rare blood disorders community

•

Interim results from the long-term XTEND-ed phase 3 study demonstrate once-weekly ALTUVIIIO continues to provide highly effective bleed protection

•

New ATLAS phase 3 study data reinforce the potential of fitusiran to provide prophylaxis for people with hemophilia A or B, with or without inhibitors

•

New Drug Application for fitusiran accepted for review by the US Food and Drug Administration, with a PDUFA date of March 28, 2025

Paris, June 21, 2024. Sanofi will present new data from its hemophilia portfolio at the 32nd Congress of the International Society on Thrombosis and Haemostasis (ISTH), taking place June 22-26, 2024, in Bangkok, Thailand. Notable presentations on ALTUVIIIO [Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein] include long-term interim phase 3 data on the efficacy and safety of the treatment in adults and children with severe hemophilia A. Abstracts on fitusiran include information on surgical experience as well as long-term safety data from the ATLAS phase 3 clinical development program in adults and adolescents with hemophilia A or B, regardless of inhibitor status.

Dietmar Berger

Chief Medical Officer, Global Head of Development

“Our presence at this year’s congress demonstrates our continued commitment to delivering innovative first- and best-in-class solutions to the hemophilia community. Hemophilia is a lifelong condition that significantly impacts people living with the disease—from risk of bleeds and poor joint health to increased risks during surgery. These data reinforce why it’s critical to have treatment options, like ALTUVIIIO and fitusiran, that deliver effective outcomes in multiple scenarios and that can be used throughout a person’s life. We look forward to working in partnership with regulatory agencies to keep bringing novel options to those living with hemophilia.”

ALTUVIIIO

Interim analyses of XTEND-ed, a long-term extension phase 3 study, showed that in adult and pediatric populations, the use of ALTUVIIIO continued to provide highly effective bleed prevention leading to improvement or maintenance of joint health over a two-year period, and a safety profile consistent with that reported in the initial studies. The following abstracts will be presented at the meeting:

 

•

“First Interim Analysis of Clinical Outcomes in Adults and Adolescents With Severe Hemophilia A Receiving Efanesoctocog Alfa Prophylaxis in XTEND-ed, a Phase 3 Long-term Extension Study”: In previously treated patients (≥12 years old) who had the completed the XTEND-1 (Arm A/B) trial, the mean annualized bleed rate (ABR) with ALTUVIIIO was 0.72 (standard deviation [SD])=1.26) for arm A and 0.42 (SD=0.89) for arm B. No factor VIII inhibitors were detected (abstract OC50.1).

•

“Interim Analysis of Joint Outcomes in Adult and Adolescent Patients with Severe Hemophilia A Receiving Efanesoctocog Alfa During the Phase 3 XTEND-ed Long-Term Extension Study”: In patients who continued to receive once weekly ALTUVIIIO (50 IU/kg) in XTEND-ed, joint health had improved or been maintained in adults and adolescents over a two-year period, as measured by Hemophilia Joint Health Score total score, total joint score, and subdomain scores (abstract OC01.4).

•

“Long-term Outcomes With Efanesoctocog Alfa Prophylaxis for Previously Treated Children With Severe Hemophilia A, an Interim Analysis of the Phase 3 XTEND-ed Study”: No factor VIII inhibitors were detected. The mean ABR was 0.70 (SD=1.27), a rate similar to the mean ABR observed in XTEND-Kids (abstract OC50.2).

 

				1/4

Internal

 

Additional data being presented at ISTH show that across clinical studies, ALTUVIIIO demonstrated effective bleed protection when used for perioperative management in participants with severe hemophilia A:

 

•

“Perioperative Management with Efanesoctocog Alfa in Adults, Adolescents, and Children with Severe Hemophilia A in the Phase 3 XTEND Clinical Program”: In 41 patients from the XTEND-1, XTEND-Kids, and XTEND-ed studies who underwent 49 major surgeries, hemostasis was maintained in all surgeries and hemostatic response with ALTUVIIIO was rated as excellent in most surgeries (43/49) (abstract OC14.1).

Fitusiran

Additional analyses will be presented at ISTH that support the potential of fitusiran as a first-in-class treatment offering consistent bleed protection for patients with hemophilia A or B, regardless of inhibitor status.

Novel results on the perioperative management of hemophilia using fitusiran prophylaxis in the ATLAS clinical development program demonstrated that major surgeries can be safely performed in patients on fitusiran:

 

•

“Surgical experience in people with hemophilia A or B with and without inhibitors receiving fitusiran”: 60 major surgeries, including 24 in people with hemophilia with inhibitors, were conducted in the fitusiran clinical development program at the time of this analysis. Major surgeries were safely and effectively conducted with fitusiran prophylaxis following bleed management guidelines, irrespective of the patient’s inhibitor status (abstract OC14.2).

Additional data presented at ISTH support the favorable safety profile for fitusiran and demonstrate that fitusiran prophylaxis under an antithrombin-based dosing regimen (AT-DR) successfully mitigated the risk of thrombotic events (TEs) and reduced the incidence of elevated liver enzymes and gallbladder inflammation or gallstones.

The following abstracts will be presented at ISTH:

 

•

“Incidence of thrombotic events in the fitusiran clinical development program”: Fitusiran prophylaxis under an AT-DR led to a marked reduction in TEs with substantially greater exposure on the AT-DR (abstract OC40.2).

•

“Hepatobiliary events in the fitusiran clinical development program with the revised AT-based dose regimen”: Fitusiran prophylaxis under an AT-DR led to reductions in liver transaminase elevations and cholecystitis/cholelithiasis events. Liver transaminase elevations were infrequent and transient, and events of cholecystitis/cholelithiasis resolved without clinical complications with no fitusiran dose interruptions or discontinuations (abstract OC40.3).

These presentations reinforce pivotal data that were presented earlier this year from the phase 3 open-label extension study (ATLAS-OLE) of fitusiran prophylaxis showing that maintaining AT activity levels between 15-35% resulted in clinically meaningful bleed control and a substantially improved benefit risk profile in people with hemophilia A or B, with or without inhibitors.

Regulatory submissions for fitusiran for the treatment of hemophilia A or B in adults and adolescents with or without inhibitors have been completed in China, Brazil and the US with a US Food and Drug Administration (FDA) target action date of March 28, 2025. The FDA also granted fitusiran Breakthrough Therapy Designation for hemophilia B with inhibitors in December 2023.

 

				2/4

Internal

 

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, 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 other 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.

ALTUVIIIO is currently approved and marketed in the US, Taiwan, and Japan. On June 17, 2024, it was approved by the European Commission for the treatment and prevention of bleeds and perioperative prophylaxis in hemophilia A under the name Altuvoct.

ALTUVIIIO is the first factor VIII therapy to receive Breakthrough Therapy Designation by the FDA in May 2022, Fast Track Designation in February 2021, and Orphan Drug Designation in 2017. The European Commission granted Orphan designation in June 2019.

About the XTEND-ed study

XTEND-ed (NCT04644575) is a phase 3 multicenter, open-label three-arm study of the long-term efficacy and safety of once-weekly ALTUVIIIO (50 IU/kg) in previously treated patients with severe hemophilia A. The study enrolled participants with severe hemophilia A from previous phase 3 studies, including adult and adolescent patients (≥12 years old) who completed the XTEND-1 study (NCT04161495) and children (<12 years old) who completed the XTEND-Kids study (NCT04759131) (arm A), newly initiated patients (arm B, China only), and newly initiated patients with planned major surgery (arm C). Participants received ALTUVIIIO prophylaxis for a total of 100 exposure days, cumulative from the initial study (52 weeks) and this study.

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, Taiwan, and Japan. 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 specialized international biopharmaceutical company transforming the lives of people with rare and debilitating diseases. Providing reliable access to innovative medicines in the areas of hematology, immunology, and specialty care, Sobi has approximately 1,800 employees across Europe, North America, the Middle East, Asia, and Australia. In 2023, revenue amounted to SEK 22.1 billion. Sobi’s share (STO:SOBI) is listed on Nasdaq Stockholm. More about Sobi at sobi.com and LinkedIn.

About fitusiran

Fitusiran is currently under clinical investigation, and its safety and efficacy have not been evaluated by any regulatory authority. Fitusiran is a potential first-in-class, antithrombin-lowering therapy for the prophylactic treatment of people with hemophilia A or B, with or without inhibitors. It is an investigational small volume, subcutaneously administered small interference RNA (siRNA) therapeutic that aims to prevent bleeds and rebalance hemostasis by lowering antithrombin, a protein that inhibits blood clotting, to promote thrombin generation. Fitusiran utilizes Alnylam Pharmaceutical Inc.’s ESC-GalNAc conjugate technology, which enables subcutaneous dosing with increased potency and durability. Fitusiran has the potential to enable prophylaxis for people around the world living with hemophilia A or B with or without inhibitors by virtue of its low overall treatment burden, with as few as six small-volume subcutaneous injections per year that do not require refrigeration.

 

				3/4

Internal

 

About the ATLAS clinical development program

The efficacy and safety of fitusiran are being investigated in the ATLAS clinical development program. The program includes the completed phase 3 studies ATLAS-INH (NCT03417102), ATLAS-A/B (NCT03417245), or ATLAS-PPX (NCT03549871) and the ongoing ATLAS-OLE (NCT03754790) study, a single-arm, phase 3, open-label study evaluating the safety and efficacy of fitusiran with a revised AT-DR, which was designed to maintain an antithrombin target range of 15%-35%. This study includes lower doses and less-frequent dosing than earlier studies. ATLAS-NEO (NCT05662319) is an additional phase 3 study currently recruiting participants to assess the frequency of treated bleeding episodes with fitusiran under the AT-DR in male adult and adolescent (≥12 years old) participants with hemophilia A or B, with or without inhibitory antibodies to factor VIII or IX, who have switched from their prior standard-of-care treatment.

 

 

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

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

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

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

Keita Browne | + 1 781 249 1766 | keita.browne@sanofi.com

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

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

Thibaud Châtelet | + 33 6 80 80 89 90 | thibaud.chatelet@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, 2023. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

All trademarks mentioned in this press release are protected.

 

				4/4

Exhibit 99.3

 

Press Release

Audrey Duval Derveloy appointed Global Head of Corporate Affairs, member of Sanofi’s Executive Committee

Paris, June 21 2024. Audrey Duval Derveloy, a seasoned healthcare industry leader and Sanofi France’s President, has been named Executive Vice President, Global Head of Corporate Affairs. Audrey will become a member of Sanofi’s Executive Committee, reporting into CEO Paul Hudson, and will be based in Paris. Her appointment is effective July 1, 2024.

In her new role, Audrey will be responsible for Sanofi’s stakeholder engagement globally, and oversee the company’s corporate social responsibility strategy, not-for-profit Global Health Unit and Sanofi’s philanthropic arm, Foundation S. Audrey retains her role as President, Sanofi France, and will continue supporting and coordinating Sanofi’s representation to its various external stakeholders in this country.

Paul Hudson

Chief Executive Officer, Sanofi

“ I am very pleased to have Audrey join our Executive Committee. Over the last two years, her leadership has been instrumental in advancing our company’s modernization in France. She has supported our strategic priorities and helped showcase Sanofi as a leading healthcare company in our home market. This recent experience, coupled with her business acumen and ability to inspire and motivate teams, paves the way for her to drive our global external engagement strategy and play a decisive part in our ambitions to become a science-driven company transforming the practice of medicine for patients across the world.”

Audrey joined Sanofi from Novartis to serve as President, Sanofi France, in September 2022. A physician by training, she started her career in public hospitals in Paris. She then worked as a Researcher at the Pasteur Research Center of Hong Kong University and later as a Scientific Expert at Salusmed, based in Hong Kong. She returned to France to join Pfizer, working in medical affairs in the areas of Endocrinology, Transplant and Rheumatology. Audrey later joined Novartis in France, where she progressively advanced to become Business Franchise Head for Ophthalmology and then, in 2020, Country President for the company’s operations in Ireland. Audrey holds a Medical Doctorate from the Paris Faculté de Médécine Cochin, and a Bachelor of Science in Medical Biology.

Audrey Duval Derveloy

Executive vice-president, Global Head of Corporate Affairs, Sanofi

“For the past two years, I have witnessed every day the unwavering commitment of our employees in France to serving patients around the world. Behind each of our successes, from the launch of Beyfortus against RSV, to the environmental transition of our industrial sites, to the mobilization of thousands of employees in support of our partnership with Paris 2024, we had the Corporate Affairs teams at our side. It is with the strength of these successes in mind that I take on these new responsibilities as we continue to modernize Sanofi and pursue our ambition to become an immunology powerhouse.”

 

 

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 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

 

				1/2

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

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

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

Keita Browne | + 1 781 249 1766 | keita.browne@sanofi.com

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

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

Thibaud Châtelet | + 33 6 80 80 89 90 | thibaud.chatelet@sanofi.com

 

				2/2

Exhibit 99.4

 

Press Release

Dupixent positive phase 3 data in children one to 11 years of age with eosinophilic esophagitis published in NEJM

 

*

Majority of patients in this age group with eosinophilic esophagitis receiving Dupixent achieved histologic remission, with improvements sustained up to one year

*

Dupixent is the first-and-only medicine indicated for eosinophilic esophagitis in the US for this age group

Paris and Tarrytown, NY, June 26, 2024. The New England Journal of Medicine has published results from a positive phase 3 study of Dupixent (dupilumab) in children aged one to 11 years with eosinophilic esophagitis (EoE). The study showed a greater proportion of those receiving weight-tiered higher dose Dupixent experienced significant improvements in many key disease measures of EoE, compared to placebo at week 16. Data from the study were the basis for the US Food and Drug Administration Priority Review and approval of Dupixent in children aged one to 11 years with EoE weighing at least 15 kg, as well as for the regulatory submission that is currently under review by the European Medicines Agency for this age group.

EoE is a chronic, progressive disease associated with type-2 inflammation that is thought to be responsible for damaging the esophagus and impairing its function. Diagnosis is difficult, as symptoms can be mistaken for other conditions, and there are delays in diagnosis. EoE can severely impact a child’s ability to eat and may also cause abdominal pain, trouble swallowing, heartburn, vomiting and failure to thrive. Continuous management of EoE may be needed to reduce the risk of complications and disease progression.

Mirna Chehade, M.D., MPH

Mount Sinai Center for Eosinophilic Disorders, Icahn School of Medicine at Mount Sinai, New York, NY, and principal investigator of the study

“The NEJM publication of these phase 3 dupilumab results is a testament to the importance of these data and potential for dupilumab to change the standard of care for many young children living with eosinophilic esophagitis. These children commonly experience feeding difficulties, food refusal and failure to thrive during a critical time of their growth and development. These data showed weight-tiered higher dose dupilumab significantly improved key eosinophilic esophagitis histologic, endoscopic, and cellular measures in children as young as 1 year old with sustained results for up to one year. These results reinforce the positive results seen in older patients with eosinophilic esophagitis and strengthen our understanding of IL4 and IL13 as key drivers of the type 2 inflammation underlying this disease.”

As published, a significantly greater proportion of children receiving either a weight-tiered higher or lower dose regimen of Dupixent achieved histologic remission at week 16 in part A of the study, compared with placebo. Additionally, those treated with higher dose Dupixent experienced significant improvements in disease severity assessed by endoscopic measures, with improvements sustained for up to one year. Those receiving lower dose Dupixent experienced improvements that were either comparable or numerically lower than the higher dose group. Dupixent also led to numerical improvement in body weight for age percentile by week 16 and sustained to one year, which was evaluated as an exploratory endpoint in part A and a secondary endpoint in part B.

 

				1/5

Safety results were generally consistent with the known safety profile of Dupixent in adolescents and adults with EoE. Adverse events more commonly observed with Dupixent (≥10%) in either weight-based dosing regimen versus placebo in the study were COVID-19, nausea, injection site pain and headache during part A. The long-term safety profile of Dupixent in children aged one to 11 years through part B was similar to that observed during part A. In part B, one case of helminth infection was reported with Dupixent.

For patients in the US with EoE weighing at least 15 kg, the FDA-approved dosage for Dupixent is 200mg or 300mg every other week, or 300mg weekly, based on weight.

Dr. Mirna Chehade has served as a paid consultant for Sanofi and Regeneron and has received research grant funding from Regeneron.

About the Dupixent pediatric eosinophilic esophagitis study

The phase 3 randomized, double-blind, placebo-controlled study evaluated the efficacy and safety of Dupixent in children aged one to 11 years with EoE. Part A enrolled 102 patients and evaluated Dupixent at a weight-tiered higher dose or lower dose regimen, compared to placebo for 16 weeks. Part B was a 36-week extended active treatment period in which eligible children from part A in the Dupixent group maintained their weight-tiered higher or lower dose level, while those in the placebo group switched to weight-tiered higher or lower dose Dupixent.

The primary endpoint was histologic remission at 16 weeks and secondary endpoints included assessments of endoscopic and histopathologic measures of the severity of disease along with clinical signs and symptoms of EoE. Change in body weight for age percentile was evaluated as an exploratory endpoint in part A and as a secondary endpoint in part B. The study is ongoing with a 108-week open-label extension period (part C) to evaluate longer-term outcomes.

About Dupixent

Dupixent (dupilumab) is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL4) and interleukin-13 (IL13) 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 studies, establishing that IL4 and IL13 are key and central drivers of the type 2 inflammation that plays a major role in multiple related and often co-morbid diseases.

Dupixent has received regulatory approvals in more than 60 countries in one or more indications including certain patients with atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis, prurigo nodularis and chronic spontaneous urticaria in different age populations. More than 850,000 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 studies involving more than 10,000 patients with various chronic diseases driven in part by type 2 inflammation.

 

				2/5

In addition to the currently approved indications, Sanofi and Regeneron are studying dupilumab in a broad range of diseases driven by type 2 inflammation or other allergic processes in phase 3 studies, including chronic spontaneous urticaria, chronic pruritus of unknown origin, chronic obstructive pulmonary disease with evidence of type 2 inflammation and bullous pemphigoid. These potential uses of dupilumab are currently under clinical investigation, and the safety and efficacy in these conditions have not been fully evaluated by any regulatory authority.

About Regeneron

Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous approved treatments and product candidates in development, most of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, and rare diseases.

Regeneron pushes the boundaries of scientific discovery and accelerates drug development using our proprietary technologies, such as VelociSuite^®, which produces optimized fully human antibodies and new classes of bispecific antibodies. We are shaping the next frontier of medicine with data-powered insights from the Regeneron Genetics Center^® and pioneering genetic medicine platforms, enabling us to identify innovative targets and complementary approaches to potentially treat or cure diseases.

For more information, please visit www.Regeneron.com or follow Regeneron on LinkedIn, Instagram, Facebook or X.

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

Sanofi 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

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

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

Keita Browne | + 1 781 249 1766 | keita.browne@sanofi.com

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

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

Thibaud Châtelet | + 33 6 80 80 89 90 | thibaud.chatelet@sanofi.com

Regeneron Media Relations

Hannah Kwagh | +1 914-847-6314| hannah.kwagh@regeneron.com

Regeneron Investor Relations

Vesna Tosic | + 914 847 5443 | vesna.tosic@regeneron.com

 

				3/5

 

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.

All trademarks mentioned in this press release are protected.

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; 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; 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 chronic spontaneous urticaria, chronic pruritus of unknown origin, chronic obstructive pulmonary disease with evidence of type 2 inflammation, bullous pemphigoid, and other potential indications; the ability of Regeneron’s collaborators, licensees, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regeneron’s Products and Regeneron’s Product Candidates; the ability of Regeneron to manage supply chains for multiple products and product candidates; safety issues resulting from the administration of Regeneron’s Products (such as Dupixent) and Regeneron’s Product Candidates in patients, including serious complications or side effects in connection with the use of Regeneron’s Products and Regeneron’s Product Candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron’s ability to continue to develop or commercialize Regeneron’s Products and Regeneron’s Product Candidates; 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), other litigation and other proceedings and government investigations relating to the Company and/or its operations (including the pending civil proceedings initiated or joined by the U.S. Department of Justice and the U.S. Attorney’s Office for the District of Massachusetts), 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, 2023 and its Form 10-Q for the quarterly period ended March 31, 2024. 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.

 

				4/5

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).

 

				5/5