SNYNF Sanofi (PK)

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 6-K

REPORT OF FOREIGN PRIVATE ISSUER

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

UNDER THE SECURITIES EXCHANGE ACT OF 1934

For the month of October 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 ☐

1

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

Exhibit Index

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.

3

Exhibit 99.1

Press Release

Sanofi and Orano join forces to develop next-generation radioligand medicines

Paris, October 17, 2024. Sanofi and Orano Med, a subsidiary of the Orano Group and a pioneer in the development of targeted alphatherapies in oncology, have entered into an agreement to combine their expertise in the fight against rare cancers and further accelerate the development of next-generation radioligand medicines.

Building on the expertise and radioligand pipeline of Orano Med, Sanofi and Orano will invest in a new entity, operating under the Orano Med brand, and focusing on the discovery, design, and clinical development of next-generation radioligand therapies (RLTs) based on lead-212 (²¹²Pb) alpha-emitting isotopes. This agreement follows Sanofi’s announcement of an exclusive licensing agreement with Orano Med and RadioMedix to advance radioligand therapies (RLTs) in rare cancers with a focus on one late-stage project, AlphaMedix^™.

Targeted alpha therapy relies on a simple concept: combining the ability of biological vectors to target cancer cells with the short-range and highly energetic cell-killing capabilities of alpha-emitting radioisotopes. The vector directs the radioisotope to the target cancer cells expressing the specific marker, even when they have spread throughout the body. This unique mechanism of action aims to damage or destroy target cancer cells, while limiting impact on nearby healthy cells. This novel precision medicine approach aims at changing the standard of care in some rare cancers to extend patients’ lives and improve their quality of life.

Paul Hudson

CEO, Sanofi

“We are excited to partner with Orano in establishing a French pioneer that unites our respective expertise in biopharma and nuclear technology to drive groundbreaking progress in the fight against cancer. As a French biopharmaceutical company, we are deeply committed to fostering and enabling innovation in our home country. This collaboration is part of a broader effort to strengthen our ties within the scientific community, both in France and globally, with the goal of advancing the development of cutting-edge treatments for patients.”

Nicolas Maes

CEO, Orano Group

“The success of Orano Med is an example of our group’s ability to diversify beyond our core nuclear business. By applying our expertise in nuclear materials to fields like targeted alpha therapies, we are demonstrating that nuclear technology can have a positive societal impact, not just for energy and climate, but also for human health. This innovation reflects Orano’s commitment to exploring new opportunities and taking bold steps to address some of the world’s most pressing challenges.”

Sanofi’s investment will further strengthen Orano Med and allow the company to accelerate the development of its pipeline, leveraging its unique capabilities in the discovery and development of lead-212 based therapies. Orano Med has also developed a highly differentiating global industrial platform, which, thanks to its vast stock of raw materials and patented manufacturing process, will ensure an independent, reliable, and scalable supply of lead-212 based therapies to patients worldwide.

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Houman Ashrafian

Executive Vice President, Head of Research and Development, Sanofi

“We are thrilled to invest in the promising field of radioligand therapies, a modality that holds potential for patients suffering from rare cancers. We see opportunity in the innovative lead-212 based technologies being developed by Orano Med, which align with our commitment to advancing transformative therapies for unmet medical needs.”

Julien Dodet

President of the Governing Board, Orano Med

“Sanofi’s partnership with Orano Med is a strong recognition of the potential of lead-212 based radioligand therapies to advance the treatment of cancers. This validates our strategy, having developed this expertise over the past 15 years, and reinforces our position as a leader in targeted alpha therapies. We look forward to combining Sanofi’s expertise with our R&D and world-class radiopharmaceutical capabilities to advance the development of potentially transformative therapies like AlphaMedix and make them available to patients in need as quickly as possible.”

In striving to become a leading immunoscience company globally, Sanofi remains committed to advancing oncology innovation. The pipeline is being reshaped and prioritized, leveraging expertise in immunoscience to drive progress. Efforts are centered on difficult-to-treat cancers such as select hematologic malignancies and solid tumors with critical unmet needs, including rare cancers such as multiple myeloma, acute myeloid leukemia, and certain types of lymphomas, as well as gastrointestinal and lung cancers.

Sanofi and Orano Med are members of the Paris Saclay Cancer Cluster and look forward to contributing to the ambitious agenda of the France 2030 plan to accelerate innovation in oncology.

This agreement is subject to standard regulatory approvals required for transactions of this nature.

Financial considerations

Under the terms of the agreement, Sanofi will make an equity investment of €300 million, approximately 16% equity stake in the new entity valued at €1.9bn.

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

About Orano Med

Orano Med, a subsidiary of the Orano Group, is a clinical-stage biotechnology company that develops a new generation of targeted therapies against cancer using the unique properties of lead-212 (²¹²Pb), an alpha-emitting radioisotope and one of the more potent therapeutic payloads against cancer cells known as Targeted Alpha-Emitter Therapy (TAT). The company is developing several treatments using ²¹²Pb combined with various targeting agents. Orano Med has ²¹²Pb manufacturing facilities, laboratories, and R&D centers in France and in the US and is currently investing to further expand its GMP-manufacturing capacities for ²¹²Pb radiolabeled pharmaceuticals in North America and Europe.

As a recognized international operator in the field of nuclear materials, Orano Group delivers solutions to address present and future global energy and health challenges. Its expertise and mastery of cutting-edge technologies enable Orano to offer its customers high value-added products and services throughout the entire fuel cycle. Every day, the Orano group’s 17,500 employees draw on their skills, unwavering dedication to safety and constant quest for innovation, with the commitment to develop know-how in the transformation and control of nuclear materials, for the climate and for a healthy and resource-efficient world, now and tomorrow.

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Contacts

Orano Med

Sophie Letournel | +33 6 38 44 34 11| sophie.letournel@orano.group

Orano Group

Press Office | +33 (0)1 34 96 12 15| press@orano.group

Orano Investor relations

Marc Quesnoy | investors@orano.group

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

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

Sanofi 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

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 apart from AlphaMedix.

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Exhibit 99.2

Press Release

Sanofi and CD&R partner to fuel Opella’s ambitions in consumer healthcare

Paris, October 21, 2024. Sanofi and CD&R announce today a plan to join forces to fuel Opella’s ambitions as a French-headquartered, global consumer healthcare champion. Sanofi and CD&R have entered exclusive negotiations for the potential sale and purchase of a 50% controlling stake in Opella. This new step in Opella’s journey paves the way for the creation of a new, standalone leader in consumer healthcare, while supporting Sanofi’s strategy and increased focus on innovative medicines and vaccines. Sanofi would remain a significant shareholder backing Opella in its future growth and path to independence. Together, CD&R and Sanofi will support Opella’s growth strategy as a pure-play, global, and fast-moving consumer healthcare company. Bpifrance is expected to participate as a minority shareholder with a c.2% stake.

Headquartered in France, Opella employs over 11,000 talented and passionate people, operates in 100 countries with 13 best-in-class and strategic manufacturing sites and four science and innovation development centers. With a portfolio of iconic brands, such as Allegra, Doliprane, and Dulcolax, Opella is already the third-largest business worldwide in the over-the-counter and vitamins, minerals & supplements market (OTC & VMS), serving more than half a billion consumers worldwide. Opella operates in a fast-growing industry driven by sustainable long-term trends, such as an aging population, rising income levels, and greater health and well-being awareness.

The valuation of Opella is based on an enterprise value of c.€16 billion, corresponding to c.14 times 2024 estimated EBITDA. The offer from CD&R is binding and fully financed. By remaining a significant shareholder in Opella, Sanofi would retain a part of the future value creation of the company. The proposed transaction is subject to finalization of definitive agreements, completion of the appropriate social processes, and subject to customary statutory approvals. The anticipated closing of the transaction would be in Q2 2025 at the earliest.

CD&R has a proven track record of partnering with corporates and management teams to support businesses’ growth and development, leveraging the firm’s global reach, deep industry expertise and broad network of operating partners and advisors. CD&R has a long history of investment in Europe and the firm’s experience building French national champions and supporting French jobs goes back more than twenty years and includes successful partnerships with, and investments in, Rexel, Spie, BUT/Conforama and Socotec.

Paul Hudson

Chief Executive Officer, Sanofi

“We are proud of what Opella and its inspired people have already accomplished. We are confident that the future of Opella will be even brighter. We share the love and emotional attachment to Opella’s brands, hence our decision to remain vested in its future. We will support Opella on its path to become an independent company, grounded in talented people, a deep consumer expertise and a truly global presence with deep roots in France. Our chosen partner CD&R has demonstrated unique capabilities in the consumer space, with deep values of respect for employees, customers, communities in which they operate, and the environment. We also welcome Bpifrance as a supporter of Opella’s development journey. At the same time, Sanofi can focus even more in bringing innovative solutions to patients suffering from debilitating or life-threatening diseases or viruses such as RSV, COPD, or multiple sclerosis.”

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Eric Rouzier

Partner and Head of European Healthcare, CD&R

“This is an exciting opportunity for CD&R to partner with Sanofi, one of the world’s leading healthcare companies, to support Opella’s ambitious management team as it invests in innovation and growth to create a French-headquartered, global consumer healthcare champion. Opella is differentiated by the quality of its brand portfolio and its highly skilled and motivated workforce. We see significant opportunities to enhance Opella’s market leadership by leveraging our deep industry expertise, broad network of operating talents, and capital resources to position the company for accelerated growth. We look forward to supporting both its French operations, including Opella’s critical manufacturing footprint and advanced R&D capabilities, and further developing its global platform to better serve employees, consumers, and patients.”

Julie Van Ongevalle

President and Chief Executive Officer, Opella

“This announcement is a major and exciting milestone in Opella’s journey. Building on significant transformations, we have grown into one of the largest global players in our sector, bringing relevant innovation to more than half a billion consumers worldwide. Partnering with CD&R will allow Opella to unlock its full development potential, to further drive value creation and deploy the exceptional talent of our teams to become a leading company in the fast-moving consumer healthcare space. We are poised to continue leveraging our strong scientific roots to grow our iconic “love brands” to meet consumers’ evolving needs and make self-care as simple as it should be.”

Accounting treatment

The proposed transaction will trigger the classification of Opella’s business as discontinued operations. From Q4 2024 and until the closing, the profit or loss of Opella, net of tax, will be included in “Net results from discontinued operations” in the Sanofi income statement. This classification as discontinued operations will also apply to previous quarters of 2024 and for comparison to all quarters of 2023. Sanofi business net income¹ used for EPS is based on the continuing operations, i.e., excluding the discontinued Opella business.

Q3 2024 results scheduled for October 25, 2024, will be reported as per the past quarters. The income statements with Opella as discontinued operations for the comparative periods of 2023 and 2024, including details by product and quarter, are expected to be provided in the coming weeks.

After the closing of the transaction, the share of results from the retained minority interest in Opella will be reported in Sanofi’s income statement as “Share of profit/loss of associates”, a line that is also excluded from Sanofi’s non-IFRS financial measures, business operating income and business net income used for EPS.

As is customary with similar transactions, Zantac² and Gold Bond are excluded from the scope of the contemplated transaction.

Guidance

The original 2024 business EPS guidance issued on February 1, 2024, and upgraded on July 25, 2024, anticipated Opella as a fully consolidated segment in Sanofi for 2024. Under the previous scope of guidance including Opella, Sanofi would have upgraded its 2024 business EPS guidance to between stable to a low single-digit percentage growth at CER³, from previously stable at CER. This upgrade is substantiated by an expected strong business performance in the third quarter that will be detailed as part of Q3 2024 results.

Under the new scope excluding Opella, preliminary business EPS in 2023 was €7.25. Sanofi expects its 2024 business EPS to grow by at least a low-single digit percentage at CER.

For 2025, Sanofi continues to anticipate a strong rebound in business EPS at CER under both the previous and the new scope.

Capital allocation

Sanofi expects to receive a cash payment upon the anticipated closing of the transaction in Q2 2025 at the earliest. The proceeds would be used in line with Sanofi’s existing capital-allocation priorities, including shareholder returns.

¹ Non-IFRS measure.

² Zantac 360° is included in the scope of the contemplated transaction.

³ Constant exchange rates.

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Sanofi’s capital-allocation priorities remain unchanged⁴, including selectively considering external growth opportunities to further accelerate the ongoing transformation into a biopharmaceutical company. Sanofi intends to maintain its current strong debt credit rating⁵.

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

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

Léo Le Bourhis | + 33 6 75 06 43 81 | leo.lebourhis@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

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, business transformations, 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”, “potential”, “outlook”, “guidance” 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, those 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 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 capital markets or other transactions, risks associated with developing standalone businesses and with intellectual property, as well as any related pending or future litigation and the ultimate outcome of such litigation, and other risks associated with trends in exchange and interest rates, volatile economic, political, financial and market conditions, cost containment initiatives, and the impact of pandemics or other global crises may have. More specifically regarding the transaction described above, these risks and uncertainties include among other things the possibility that the transaction will not be completed, or if completed, will not be completed in the expected timeframe, an unexpected failure to satisfy the required signing or closing conditions, or unexpected delays in meeting these requirements, the ability to obtain regulatory clearances, the possibility that the expected strategic benefits, synergies or opportunities from the transaction may not be realized, or may take longer to realize than expected, or potential adverse reactions to the proposed transaction by customers, suppliers, strategic partners or key Sanofi or Opella employees. 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.

⁴ Organic investment, M&A/business development, growing dividend, and anti-dilutive share buybacks.

⁵ Moody A1 (stable) and S&P AA (stable).

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