SNY Sanofi

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 ☐

1

In December 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

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

Availability of the profit and loss information of Sanofi excluding Opella

Paris, France – December 6, 2024. Following the press release on October 21, 2024 and the plan to transfer a 50% controlling stake in Opella (consumer healthcare) to CD&R, the financial information for Sanofi reflecting the new scope, excluding Opella, is now available on the “Investors” section of sanofi.com in one convenient spreadsheet file.

The update of the income statement information reclassifies Opella’s business as discontinued operations, in line with the planned transition of Sanofi to a focused, science-driven biopharma company.

The financial data include details on sales, segment information, business net income and reported IFRS net income of Sanofi excluding Opella. From Q4 2024 and until the closing of the transaction, the profit or loss of Opella, net of tax, is included in “Net income / (loss) from discontinued operations” in the Sanofi income statement. This classification as discontinued operations as well as the full financial data apply to all previous quarters of 2024 and for comparison to all quarters of 2023.

Sanofi’s Q4 2024 results, reflecting the new scope excluding Opella, are expected to be published on January 30, 2025.

About Sanofi

We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people’s lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions.

Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY

Media Relations

Sandrine Guendoul | + 33 6 25 09 14 25 | sandrine.guendoul@sanofi.com

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

Léo Le Bourhis | + 33 6 75 06 43 81 | leo.lebourhis@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 75 45 51 36 93| thomas.larsen@sanofi.com

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

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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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Exhibit 99.2

Press Release

ASH: rilzabrutinib demonstrated significant patient benefit in the first positive phase 3 study of a BTK inhibitor in ITP

Paris, December 7, 2024. Positive results from the pivotal LUNA 3 phase 3 study of rilzabrutinib in adults with persistent or chronic immune thrombocytopenia (ITP), a rare immune-mediated disease, reinforce the efficacy and safety of rilzabrutinib, an oral, reversible, covalent Bruton’s tyrosine kinase (BTK) inhibitor, and further support its potential as a first-in-class treatment for ITP. Platelet response was achieved in 65% (n=86) of patients receiving rilzabrutinib compared to 33% (n=23) of patients on placebo. The primary endpoint was met, with rilzabrutinib demonstrating durable platelet response in 23% of ITP adult patients compared to 0% on the placebo arm (p<0.0001), as well as key secondary endpoints including reduced bleeding, number of weeks with platelet response, the need for rescue therapy use, and improved physical fatigue and quality of life measures.

These results were presented today at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition in San Diego, December 7-10, 2024.

David Kuter, MD

Director of Clinical Hematology at Massachusetts General Hospital and Professor of Medicine at Harvard Medical School, study author

“People living with immune thrombocytopenia who cannot tolerate or do not respond to medications aimed at raising platelet counts are at risk of uncontrolled bleeding and often endure side effects from steroids and other available therapies. A significant percentage of these patients also suffer from severe fatigue and an impaired quality of life. I’m encouraged by the robust therapeutic effects I’ve seen in patients of the LUNA 3 study across all aspects of the disease, including clinically meaningful and sustained improvements in platelet count, quality of life metrics, reduction in bleeding, and a favorable safety profile.”

In the pivotal LUNA 3 study, adult patients with persistent or chronic ITP and severely low platelet counts (median of 15,000/µL) received oral rilzabrutinib 400 mg twice a day (n=133) or placebo (n=69) for up to 24 weeks followed by 28 weeks of open-label period and demonstrated the following results:

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The safety profile of rilzabrutinib was consistent with previous studies. The rates of adverse events (AEs) were similar in patients receiving rilzabrutinib and patients receiving placebo; the most common treatment-related AEs for rilzabrutinib were mild/moderate (grade 1/2), including diarrhea (23%), nausea (17%), headache (8%) and abdominal pain (6%).

Rilzabrutinib is an investigational medicine, and its safety and efficacy have not been fully evaluated by any regulatory authority. Rilzabrutinib is currently under regulatory review in the US and the EU, with a US Food and Drug Administration target action date of August 29, 2025.

Dietmar Berger, MD, PhD

Chief Medical Officer, Global Head of Development, Sanofi

“These new data support the potential of rilzabrutinib to provide robust and durable platelet response in immune thrombocytopenia, offering hope for patients with limited treatment options. Based on its ability to target BTK, an enzyme that plays a critical role in many types of immune cells, we believe rilzabrutinib also has the potential to improve patient outcomes in multiple rare blood and autoimmune disorders.”

In addition to ITP, rilzabrutinib is being studied across a variety of immune-mediated diseases. Positive results from a phase 2 study of rilzabrutinib in warm autoimmune hemolytic anemia (wAIHA) and preclinical data in sickle cell disease were also presented at ASH.

A full list of rilzabrutinib abstracts and presentations is included below.

5 abstracts; 1 oral presentation

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About the LUNA 3 study

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. 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. 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 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, physical fatigue score, and bleeding score.

About rilzabrutinib

Rilzabrutinib is an oral, reversible, covalent BTK inhibitor that has the potential to be a first- and best-in-class treatment of several immune-mediated and inflammatory diseases. BTK, expressed in B cells, macrophages, and other immune cells, 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 while potentially reducing the risk of off-target side effects.

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.

Rilzabrutinib is being studied across a variety of immune-mediated diseases, including immune thrombocytopenia, warm autoimmune hemolytic anemia (phase 2), asthma (phase 2), chronic spontaneous urticaria (phase 2).

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

About ITP

ITP is a rare, complex autoimmune disorder characterized by low platelet counts (less than 100,000/µL) resulting from both increased platelet destruction and decreased platelet production. Beyond bruising and bleeding, which can include potentially life-threatening episodes like intracranial hemorrhage, people living with ITP may experience arterial or venous thrombosis. They also often experience easily overlooked symptoms that significantly impair their quality of life, such as unexplained fatigue, anxiety or depression, and cognitive impairment. With its multiple mechanisms of action that target B cells and macrophages, both of which express BTK and potentially other inflammatory pathways, rilzabrutinib may address the underlying mechanisms responsible for a wide range of ITP complications.

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

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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

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 the property of the Sanofi group.

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Exhibit 99.3

Press Release

ASH: Sarclisa combinations demonstrated significant benefits in newly diagnosed multiple myeloma patients

Paris, December 9, 2024. New data from three oral presentations, which demonstrated significant clinical benefit with Sarclisa-based quadruplets in newly diagnosed multiple myeloma (NDMM) patients were featured at the 66th American Society of Hematology (ASH) Annual Meeting & Exposition in San Diego, CA, US. The presentations, including results from the IMROZ and German-speaking Myeloma Multicenter Group (GMMG)-HD7 phase 3 studies, showcased deep and durable responses and improved long-term outcomes with Sarclisa when added to current standard-of-care NDMM regimens.

Dietmar Berger, MD, PhD

Chief Medical Officer, Global Head of Development at Sanofi

“An important part of our approach to scientific innovation in oncology is identifying synergistic combinations, which may allow us to impact numerous unmet needs with a single therapy and expand the pool of patients who could one day benefit from our medicines. Results from key studies evaluating Sarclisa combinations further reinforce our confidence in this strategy and speak to the potential benefit of Sarclisa as a backbone therapy for newly diagnosed multiple myeloma, regardless of transplant eligibility.”

Additional IMROZ phase 3 study analysis evaluating MRD in transplant-ineligible (TI) NDMM patients

The IMROZ phase 3 study demonstrated that Sarclisa in combination with standard-of-care bortezomib, lenalidomide and dexamethasone (VRd), followed by Sarclisa-Rd, improved progression-free survival (PFS) and led to a rapid and greater depth of response compared to VRd alone, as shown by minimal residual disease (MRD) negativity rate over time, in TI NDMM patients. MRD negativity represents a measure of malignant cells left in the bone marrow after treatment and has been increasingly used as a surrogate endpoint for PFS in MM research. Numerous independent studies have shown a correlation between MRD negativity, deeper treatment responses and improved long-term outcomes.

Sarclisa-VRd demonstrated a consistent benefit at every time point up to 60 months and led to the highest MRD negativity rate of a NDMM regimen with a VRd backbone, when evaluating exclusively TI patients.

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Robert Orlowski, MD, PhD

Florence Maude Thomas Cancer Research Professor at The University of Texas MD Anderson Cancer Center

“MRD negativity has long been used to infer deeper responses and improved outcomes in multiple myeloma research, but few studies have evaluated sustained MRD negativity beyond one year. In the latest analysis from the IMROZ study, one of the longest to evaluate MRD negativity with a CD38-based quadruplet, newly diagnosed transplant-ineligible patients treated with isatuximab-VRd were more likely to achieve this threshold compared to those receiving VRd alone and maintain it as long as three years. When viewed in tandem with earlier findings highlighting the significant progression-free survival benefit from IMROZ, these data reinforce the potential of isatuximab to generate deep and durable improvements in clinical outcomes throughout treatment when added to the standard-of-care regimen.”

New key results from the GMMG-HD7 study in transplant-eligible (TE) NDMM

New data from the induction part of the GMMG-HD7 phase 3 study were featured across two oral presentations at ASH. GMMG-HD7 is an investigational, pivotal, randomized, open-label, multicenter, 2-part phase 3 study evaluating Sarclisa in combination with RVd versus RVd induction followed by post-transplant re-randomization to Sarclisa plus lenalidomide versus lenalidomide maintenance in TE NDMM patients. The following results, which were simultaneously published in the Journal of Clinical Oncology, were reported for Sarclisa-RVd compared to RVd in the first part:

The safety and tolerability in this study were consistent with the established safety profile of Sarclisa and RVd with no new safety signals observed.

GMMG-HD7 is the first and only phase 3 study to demonstrate a deep and rapid response with an anti-CD38-based induction regimen in TE NDMM patients, regardless of maintenance therapy, alongside a statistically significant MRD negativity benefit post-induction, without consolidation. Additionally, the data showed the highest post-induction and post-transplant MRD negativity rates of any CD38 monoclonal antibody using RVd as a backbone in TE NDMM. The results add to the growing body of clinical evidence supporting the use of Sarclisa in the front-line setting.

Hartmut Goldschmidt, MD

President of GMMG, Professor of Medicine at the Heidelberg University Hospital (UKHD), Germany and principal investigator of the study

“Successful induction therapy prior to autologous stem cell transplant is critical to achieving optimal outcomes in front-line multiple myeloma treatment. In the GMMG-HD7 study, we observed a significant and sustained progression-free survival benefit when adding isatuximab to the current standard-of-care induction regimen, reinforcing the potential of this quadruplet when used prior to transplant, regardless of the maintenance therapy.”

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Advancing Sarclisa combinations in hematologic malignancies

A fourth oral presentation at ASH featured interim results from the investigational ISAMYP phase 2 study in AL amyloidosis, another rare disease. Results showed the addition of Sarclisa to pomalidomide, and dexamethasone (Pd) resulted in rapid hematological responses in patients with relapsed AL amyloidosis, who experienced suboptimal response to previous therapy or at relapse. AL amyloidosis is a rare plasma cell disorder associated with particularly poor outcomes in the later stages of the disease. Although recent treatment advancements have helped improve outcomes for certain patient segments, unmet needs continue to exist, particularly for frail or TI populations.

The safety and efficacy of Sarclisa in combination with Pd for AL amyloidosis has not been evaluated by any regulatory authority.

About the IMROZ study

The randomized, multi-center, open label IMROZ phase 3 study enrolled 446 patients with TI NDMM across 21 countries and 96 centers. During the study, Sarclisa was administered through an intravenous infusion at a dose of 10 mg/kg once weekly for five weeks during first 42-day cycle and once every two weeks in cycles 2 to 4 in combination with subcutaneous bortezomib, oral lenalidomide and intravenous or oral dexamethasone. Then Sarclisa was administered every 2 weeks from cycle 5 to 17 and every 4 weeks in cycles 18+ during 28-day cycles in combination with lenalidomide and dexamethasone at the standard dose, until disease progression, unacceptable toxicity, or patient’s decision to stop the study treatment. The primary endpoint of IMROZ is PFS. Key secondary endpoints include complete response rate, MRD negativity rate for patients with a complete response, very good partial response or better rate, and overall survival. Other secondary endpoints are overall response rate, time to progression, duration of response, time to first response, time to best response, PFS on next line of therapy, PFS by MRD status, sustained MRD negativity greater than or equal to 12 months rate, safety, pharmacokinetic profile, immunogenicity, disease-specific and generic health-related quality of life, disease and treatment-related symptoms, health state utility, and health status.

In September 2024, Sarclisa was approved in the US in combination with VRd as a front-line treatment option for adult patients with NDMM who are not eligible for ASCT, based on results from the IMROZ phase 3 study. In November 2024, the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the approval of Sarclisa-VRd for the treatment of adult patients with NDMM who are ineligible for ASCT. Additionally, applications for this indication are currently under regulatory review in Japan and China.

About the GMMG-HD7 study

GMMG-HD7 is an investigational, pivotal, randomized, open-label, multicenter, 2-part phase 3 study evaluating Sarclisa in combination with RVd versus RVd induction followed by post-transplant re-randomization to Sarclisa plus lenalidomide versus lenalidomide maintenance in TE NDMM patients. The GMMG-initiated study is being conducted in close collaboration with Sanofi based on jointly defined research. Sanofi provided financial support to GMMG for this study. In December 2021, Sanofi and GMMG shared results from part one, which met the primary endpoint of MRD negativity after induction therapy and before transplant in NDMM patients.

The study enrolled 662 patients with TE NDMM across 67 sites in Germany. In the first part of the study, all participants were equally randomized to receive three 42-day cycles of RVd in both arms of the study, while Sarclisa was added to only one study arm. In the second part of the study, patients were re-randomized post-transplant to receive Sarclisa plus lenalidomide or lenalidomide alone as maintenance therapy. During the study, Sarclisa was administered through an intravenous infusion at a dose of 10 mg/kg once weekly for the first four weeks of cycle one, then every other week for the rest of the induction period.

MRD negativity was assessed by next-generation flow cytometry (sensitivity of 1x10^-5) after induction. In the latest readout of the study, PFS for both Sarclisa plus RVd as an induction

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therapy, regardless of maintenance treatment, and Sarclisa plus lenalidomide as a maintenance regimen were measured from first randomization.

GMMG-HD7 protocol defined the primary endpoints of MRD negativity after induction treatment for the first part of the study, and PFS following the second randomization after transplant for part two of the study, in which Sarclisa was added to lenalidomide maintenance, with the latter primary endpoint anticipated to be available later. The key secondary endpoint for the first part of the study was PFS from first randomization. Additional secondary endpoints included rates of complete response after induction, and intensification, overall survival, and safety.

The use of Sarclisa in combination with RVd is investigational and has not been evaluated by any regulatory authority. Submission of an application for this combination in the EU is anticipated in the coming months.

About Sarclisa

Sarclisa (isatuximab) is a CD38 monoclonal antibody that binds to a specific epitope on the CD38 receptor on MM cells, inducing distinct antitumor activity. It is designed to work through multiple mechanisms of action including programmed tumor cell death (apoptosis) and immunomodulatory activity. CD38 is highly and uniformly expressed on the surface of MM cells, making it a target for antibody-based therapeutics such as Sarclisa. In the US, the non-proprietary name for Sarclisa is isatuximab-irfc, with irfc as the suffix designated in accordance with nonproprietary naming of biological products guidance for industry issued by the US FDA.

Currently Sarclisa is approved in more than 50 countries, including the US and EU, across two indications; Sarclisa is approved under an additional indication in the US. Based on the ICARIA-MM phase 3 study, Sarclisa is approved in combination with Pd for the treatment of patients with relapsed refractory MM (R/R MM) who have received ≥2 prior therapies, including lenalidomide and a proteasome inhibitor and who progressed on last therapy. Based on the IKEMA phase 3 study, Sarclisa is also approved in 50 countries in combination with carfilzomib and dexamethasone, including in the US for the treatment of patients with R/R MM who have received 1–3 prior lines of therapy and in the EU for patients with MM who have received at least 1 prior therapy. In the US, Sarclisa is approved in combination with VRd as a front-line treatment option for adult patients with NDMM who are not eligible for ASCT, based on the IMROZ phase 3 study. On November 14, 2024, the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the approval of Sarclisa-VRd in this patient population. A final decision is expected in the coming months.

Sanofi continues to advance Sarclisa as part of a patient-centric clinical development program, which includes several phase 2 and phase 3 studies across the MM treatment continuum spanning six potential indications. In addition, the company is evaluating a subcutaneous administration method for Sarclisa in clinical studies. The safety and efficacy of Sarclisa has not been evaluated by any regulatory authority outside of its approved indications and methods of delivery.

In striving to become the number one immunoscience company globally, Sanofi remains committed to advancing oncology innovation. Through focused strategic decisions the company has reshaped and prioritized its pipeline, leveraging its expertise in immunoscience to drive progress. Efforts are centered on difficult-to-treat often rare cancers such as select hematologic malignancies and solid tumors with critical unmet needs, including multiple myeloma, acute myeloid leukemia, certain types of lymphomas, as well as gastrointestinal and lung cancers.

For more information on Sarclisa clinical studies, please visit www.clinicaltrials.gov.

About the German-speaking Myeloma Multicenter Group (GMMG)

GMMG is the largest study group focusing on MM in Germany, with headquarters based in Heidelberg. Within the last 20+ years, the GMMG study group has performed numerous studies including five randomized, multicenter phase 3 studies with 4,000 patients enrolled from about 90 participating and co-treating centers throughout Germany. The overall goal of GMMG is to

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generate improved therapies for myeloma patients through the development and testing of novel and personalized, genome- and signaling-driven treatment strategies. The GMMG has set itself the goal of achieving further approvals for effective antibody-based drug combinations for the first-line treatment of myeloma patients, in which antibody-based treatment regimens have been integrated into seven GMMG study concepts (CONCEPT, DANTE, DADA, HD6, HD7, HD8, HD9 and HD10).

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

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

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

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 Châtalet | +33 6 80 80 89 90 | thibaud.chatalet@sanofi.com

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 the property of the Sanofi group.

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Exhibit 99.4

Press Release

Two combination vaccine candidates for prevention of influenza and COVID-19 granted Fast Track designation in the US

Paris, December 11, 2024. The US Food and Drug Administration has granted Fast Track designation to two Sanofi combination vaccine candidates to prevent influenza and COVID-19 infections in individuals 50 years of age and older. Both candidates combine two already licensed and authorized vaccines with proven efficacy through randomized controlled studies, and with favorable tolerability.

The first combination vaccine candidate (NCT06695117) consists of the influenza protein-based trivalent vaccine Fluzone High-Dose combined with the adjuvanted recombinant Novavax COVID-19 vaccine. The second candidate (NCT06695130) combines the influenza recombinant protein-based trivalent vaccine Flublok with the Novavax COVID-19 vaccine.

Both Fluzone High-Dose and Flublok have been proven to prevent more influenza infections in older adults than standard-dose influenza vaccines in pivotal randomized clinical studies. Additionally, in real-world evidence studies they have demonstrated significant and consistent reductions in flu-related hospitalizations. The Novavax COVID-19 vaccine has been shown to have a better tolerability profile than currently available mRNA COVID-19 vaccines when administered as a booster dose. It has also demonstrated high efficacy against COVID-19 as primary vaccination in two pivotal phase 3 studies.

Thomas Triomphe

Executive Vice President, Vaccines, Sanofi

“Building on our immunology expertise and on 12 years of robust clinical and real-world data, we aim to continue leading the way in protection against flu and its severe outcomes. Our goal is to develop a combined flu and COVID-19 vaccine that offers simpler scheduling and fewer injections without compromising on the industry leading levels of efficacy, safety and tolerability of the standalone vaccines included in our combination vaccine.”

Fast Track designation was granted based on the potential for the combination vaccine candidates to address the significant individual and healthcare system burden of two serious illnesses that can result in hospitalization and death, particularly among older adults.

Sanofi has initiated two separate phase 1/2 parallel, randomized, modified double-blind, multi-arm studies (NCT06695117 and NCT06695130) to evaluate the safety and immune response induced by the two combination vaccine candidates.

About NCT06695117 and NCT06695130

The two combination vaccine candidates consist of:

One recent systematic review and meta-analysis suggests a combination booster vaccine could increase the uptake of COVID-19 vaccines among the 50 years and above age group by 56%.

Combination vaccines may also be attractive to healthcare professionals conducting immunization programs as they may be easier and quicker to administer with fewer injections to protect against multiple diseases, less errors and decreased syringe and vial disposal requirements.

Influenza (flu) is a contagious, acute viral respiratory disease. Every year, there are an estimated 290,000 to 650,000 influenza-related respiratory deaths globally. In developed countries most deaths associated with flu occur in people aged 65 years or older.

Adults aged 65 or older account for most hospitalizations from flu. Among this population there is a higher hospitalization rate for flu with 2-fold longer average length of hospital stay than with younger adults. One quarter of patients are readmitted to hospital within 90-days post-discharge.

Flu can wreak havoc across major organ systems. It can lead to an 8-fold increased risk of stroke and pneumonia, a 10-fold increased risk of heart attack and among older adults hospitalized for flu, 1 in 5 experience a decline in their ability to independently undertake simple daily tasks, such as bathing, and dressing themselves.

Coronavirus disease (COVID-19) is an infectious disease caused by the SARS-CoV-2 virus. Most people infected with the virus will experience mild to moderate respiratory illness and recover without requiring special treatment. However, some will become seriously ill resulting in hospitalization and death.

Many individuals continue to experience long-term sequelae following COVID-19, also referred to as “long COVID”. Long COVID symptoms can vary from mild to severe, potentially necessitating extensive medical attention, and may even lead to disability. A meta-analysis of 12 studies shows that 30% of COVID-19 patients have persistent symptoms two years after infection, the most common of which are fatigue, cognitive problems, and pain.

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

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

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

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 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 the property of the Sanofi group.