Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]

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 December 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 ☐

 

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In December 2024, Sanofi published the press releases attached hereto as Exhibits 99.1 and 99.2 which are incorporated herein by reference.

Exhibit Index

 

Exhibit No.		Description
Exhibit 99.1		Press Release dated December 19, 2024 : Jean-Paul Kress to join Sanofi’s Board of Directors
Exhibit 99.2		Press Release dated December 23, 2024 : Sanofi initiates phase 3 program for PCV21 and expands collaboration with SK bioscience for next-generation pneumococcal conjugate vaccines

 

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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: December 23, 2024						SANOFI
				By		/s/ Alexandra Roger
						Name: Alexandra Roger
						Title: Head of Legal Corporate & Finance

 

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Exhibit 99.1

 

Press Release

Jean-Paul Kress to join Sanofi’s Board of Directors

Paris, December 19, 2024. Sanofi’s Board of Directors is pleased to welcome Jean-Paul Kress as an independent director as of January 1, 2025, replacing Gilles Schnepp who has decided to leave the Board at the end of 2024. Jean-Paul Kress will hold his position for the remainder of Gilles Schnepp’s term of office and his appointment will be subject to ratification at the next Ordinary Shareholders’ Meeting of Sanofi.

Jean-Paul Kress, M.D., served as the CEO of MorphoSys from 2019 until it was acquired by Novartis in 2024. He led the company in its mission – More life for people with cancer – and has spearheaded its transformation into a global biopharmaceutical company developing and commercializing novel cancer medicines. Prior to this, Jean-Paul Kress was the CEO of Syntimmune, where he sharpened the company’s focus on late-stage clinical development in auto-immune diseases until the company’s acquisition by Alexion. He has also held several senior leadership roles at other pharmaceutical companies in the US and in Europe. Jean-Paul Kress served as Chairman of the Board of Directors at ERYTECH Pharma and was a member of Sarepta Therapeutics’ Board of Directors. He received his M.D. from Faculté Necker-Enfants Malades in Paris and Master of Sciences in molecular and cellular pharmacology from Ecole normale supérieure (Ulm) in Paris.

Frédéric Oudéa

Chairman of the Board of Directors

“I extend my heartfelt gratitude to Gilles Schnepp for his unwavering dedication to the Board, and particularly his pivotal contribution to the evolution of the company’s governance in 2023. The Board is delighted to welcome Jean-Paul Kress as its newest director. With over 30 years of diverse executive experience in the pharmaceutical sector, spanning large corporations and biotech firms, Jean-Paul brings exceptional global expertise to the Board. His insights will be invaluable in guiding the company’s ongoing strategic evolution in the biopharmaceutical field.”

Regarding the organization of the Board Committees, Patrick Kron will take over as Chairman of the Appointments, Governance and CSR Committee and Jean-Paul Kress will join the Strategy Committee and the Scientific Committee.

 

 

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 | [e-mail]

Evan Berland | [phone] | [e-mail]

Nicolas Obrist | + 33 6 77 21 27 55 | [e-mail]

Léo Le Bourhis | + 33 6 75 06 43 81 | [e-mail]

Victor Rouault | + 33 6 70 93 71 40 | [e-mail]

Timothy Gilbert | + 1 516 521 2929 | [e-mail]

Investor Relations

Thomas Kudsk Larsen |+ 44 7545 513 693 | [e-mail]

Alizé Kaisserian | + 33 6 47 04 12 11 | [e-mail]

Felix Lauscher | + 1 908 612 7239 | [e-mail]

Keita Browne | + 1 781 249 1766 | [e-mail]

 

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Nathalie Pham | + 33 7 85 93 30 17 | [e-mail]

Tarik Elgoutni | + 1 617 710 3587 | [e-mail]

Thibaud Châtelet | + 33 6 80 80 89 90 | [e-mail]

 

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Exhibit 99.2

 

Press Release

Sanofi initiates phase 3 program for PCV21 and expands collaboration with SK bioscience for next-generation pneumococcal conjugate vaccines

 

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Pneumococcal disease remains a major global health challenge despite the availability of current vaccines

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This 21-valent pneumococcal conjugate vaccine (PCV21) is the first pneumococcal conjugate vaccine candidate with more than 20 serotypes to enter phase 3 in infants & toddlers

Paris, December 23, 2024. Sanofi and SK bioscience have entered into a new chapter of their collaboration in pneumococcal vaccines with an expanded agreement to develop, license and commercialize next-generation PCVs for both pediatric and adult populations, reaffirming their commitment to fighting pneumococcal disease.

Despite decades of public health vaccination programs, invasive pneumococcal disease (IPD) continues to inflict a substantial burden of disease, primarily due to Streptococcus pneumoniae serotypes that are not included in currently available conjugate vaccines. Next-generation PCVs have the potential to extend vaccine coverage of disease-causing serotypes.

This expansion builds on the companies’ existing collaboration to develop and commercialize a PCV21 pediatric vaccine, for which the phase 3 clinical program commenced last week. This vaccine candidate is the first-ever PCV containing more than 20 serotypes to enter a phase 3 clinical study in infants and toddlers.

Thomas Triomphe

Executive Vice President, Vaccines, Sanofi

“Given the vast unmet public health needs in IPD, we’re delighted to expand this collaboration and continue our pursuit of innovative work in PCV. Our collaboration leverages SK bioscience’s capabilities and Sanofi’s expertise in developing and bringing innovative vaccines to people worldwide with the collective aim of reducing the global impact of pneumococcal disease.”

Jaeyong Ahn

CEO and President of SK bioscience

“We’re thrilled about the expansion of our collaboration with Sanofi, which serves as the core of our strategy to develop new solutions to combat pneumococcal disease. The ongoing expansion of our state-of-the-art manufacturing base, cofinanced by Sanofi, will support launch of PCV21 and future next generation vaccines.”

The PCV21 phase 3 program is based on positive phase 2 results communicated last year and will include more than 7,700 infants, toddlers, young children and adolescents across multiple geographies, including the US, Europe, Australia, Asia, and Latin America.

Under the terms of their expanded agreement, both companies will co-fund research and development costs. Sanofi will pay EUR 50M upfront to SK bioscience, followed by development and commercial milestone payments. Once registered, Sanofi will commercialize the vaccines worldwide except for South Korea, where SK bioscience will have commercial exclusivity. SK bioscience will receive royalty payments on product sales outside South Korea.

 

 

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

 

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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 | [e-mail]

Evan Berland | [phone] | [e-mail]

Nicolas Obrist | + 33 6 77 21 27 55 | [e-mail]

Léo Le Bourhis | + 33 6 75 06 43 81 | [e-mail]

Victor Rouault | + 33 6 70 93 71 40 | [e-mail]

Timothy Gilbert | + 1 516 521 2929 | [e-mail]

Investor Relations

Thomas Kudsk Larsen |+ 44 7545 513 693 | [e-mail]

Alizé Kaisserian | + 33 6 47 04 12 11 | [e-mail]

Felix Lauscher | + 1 908 612 7239 | [e-mail]

Keita Browne | + 1 781 249 1766 | [e-mail]

Nathalie Pham | + 33 7 85 93 30 17 | [e-mail]

Tarik Elgoutni | + 1 617 710 3587 | [e-mail]

 

 

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 the property of the Sanofi group.

 

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