Statistik Asas
| LEI | 549300E9PC51EN656011 |
| CIK | 1121404 |
SEC Filings
All companies that sell securities in the United States must register with the Securities and Exchange Commission (SEC) and file reports on a regular basis.
These reports include company annual reports (10K, 10Q), news updates (8K), investor presentations (found in 8Ks), insider trades (form 4), ownership reports (13D, and 13G), and reports related to the specific securities sold, such as registration statements and prospectus. This page shows recent SEC filings related to Sanofi - Depositary Receipt (Common Stock)
SEC Filings (Chronological Order)
Halaman ini menyediakan senarai kronologi lengkap bagi Pemfailan SEC, tidak termasuk pemfailan pemilikan yang kami sediakan di tempat lain.
| September 4, 2025 |
EX-99.1 Exhibit 99.1 Press Release Sanofi’s amlitelimab met all primary and key secondary endpoints in the COAST 1 phase 3 study in adults and adolescents with atopic dermatitis • Amlitelimab, dosed every four weeks or every 12 weeks, demonstrated statistically significant and clinically meaningful efficacy in skin clearance and disease severity compared to placebo at Week 24, with efficacy progre |
|
| September 4, 2025 |
6-K 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 September 2025 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 of |
|
| September 3, 2025 |
Sanofi’s Wayrilz approved in US as first BTK inhibitor for immune thrombocytopenia EX-99.1 Exhibit 99.1 Press Release Sanofi’s Wayrilz approved in US as first BTK inhibitor for immune thrombocytopenia • Novel treatment targets BTK through multi-immune modulation to help address root causes of ITP • Approval based on LUNA 3 phase 3 study that demonstrated rapid and durable platelet response and improvements in other ITP symptoms • ITP is a disease of complex immune dysregulation |
|
| September 3, 2025 |
6-K 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 September 2025 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 of |
|
| August 29, 2025 |
6-K 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 August 2025 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 offic |
|
| August 29, 2025 |
Sanofi’s rilzabrutinib earns orphan designation in the EU for IgG4-related disease EX-99.1 Exhibit 99.1 Press Release Sanofi’s rilzabrutinib earns orphan designation in the EU for IgG4-related disease • Data from the positive Phase 2 study evaluating rilzabrutinib for the treatment of IgG4-related disease presented at EULAR 2025 • Additional orphan designation underscores Sanofi commitment to advancing new medicines in immune-mediated rare diseases Paris, August 14, 2025. The Eu |
|
| August 7, 2025 |
Sanofi completes the acquisition of Vigil Neuroscience, Inc. EX-99.1 Exhibit 99.1 Press Release Sanofi completes the acquisition of Vigil Neuroscience, Inc. Paris, August 6, 2025. Sanofi announces the completion of its acquisition of Vigil Neuroscience, Inc. (“Vigil”). This acquisition strengthens Sanofi’s early-stage pipeline in neurology with VG-3927, a novel, oral, small-molecule TREM2 agonist, which will be evaluated in a phase 2 clinical study in patie |
|
| August 7, 2025 |
6-K 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 August 2025 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 offic |
|
| July 31, 2025 |
6-K 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 2025 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 |
|
| July 31, 2025 |
EX-99.2 Exhibit 99.2 Press Release Sanofi’s SAR446523, a GPRC5D monoclonal antibody, earns orphan drug designation in the US for multiple myeloma • Designation granted for IgG1-based GPRC5D monoclonal antibody for the potential treatment of patients with relapsed or refractory multiple myeloma Paris, July 30, 2025. The US Food and Drug Administration (FDA) has granted orphan drug designation to S |
|
| July 31, 2025 |
Press Release Q2: double-digit sales and solid business EPS growth. 2025 sales guidance is now high single-digit growth, at upper end of range Paris, July 31, 2025 Q2 sales growth of 10.1% at CER1 and business EPS2 of €1.59 •Pharma launches increased sales by 39.8%, reaching €0.9 billion, driven by ALTUVIIIO •Dupixent sales increased by 21.1% to €3.8 billion, supported by the COPD launch •Vaccines |
|
| July 31, 2025 |
EX-99.1 Exhibit 99.1 Press Release Sanofi’s Sarclisa approved in the EU for the treatment of transplant-eligible newly diagnosed multiple myeloma • Approval based on GMMG-HD7 phase 3 study demonstrating that Sarclisa with VRd induction treatment significantly improved MRD negativity benefit and prolonged PFS compared to VRd alone • With the first global approval in TE NDMM, Sarclisa is now approve |
|
| July 31, 2025 |
Anne-Claire Ferrié Amélie Graffan Exhibit 99.2 Exhibit 99.2 TABLE OF CONTENTS 2. Half-year management report 36 A/ Significant events of the first half of 2025 36 B/ Progress on implementation of the corporate social responsibility strategy 41 C/ Events subsequent to June 30, 2025 42 D/ Consolidated financial statements for the first half of 2025 43 E/ Risk factors and related party transactions 57 F/ Outlook 58 G/ Appendix - rese |
|
| July 31, 2025 |
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 2025 Commission File Number: 001-31368 SANOFI (Translation of registrant’s name into English) 46 avenue de la Grande Armée – 75017 Paris (Address of principal executive offices) Indicate b |
|
| July 31, 2025 |
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 2025 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) In |
|
| July 31, 2025 |
2 SANOFI HALF-YEAR FINANCIAL REPORT 2025 Exhibit 99.1 Exhibit 99.1 TABLE OF CONTENTS 1. Condensed half-year consolidated financial statements 2 Consolidated balance sheets - assets 2 Consolidated balance sheets - equity and liabilities 3 Consolidated income statements 4 Consolidated statements of comprehensive income 5 Consolidated statements of changes in equity 6 Consolidated statement of cash flows 8 Notes to the condensed half-year c |
|
| July 22, 2025 |
6-K 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 2025 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 |
|
| July 22, 2025 |
Sanofi to acquire Vicebio, expanding respiratory vaccines pipeline EX-99.2 Exhibit 99.2 Press Release Sanofi to acquire Vicebio, expanding respiratory vaccines pipeline Paris, July 22, 2025. Sanofi today announces it has entered into an agreement to acquire Vicebio Ltd (“Vicebio”), a privately held biotechnology company headquartered in London, UK. The acquisition brings an early-stage combination vaccine candidate for respiratory syncytial virus (RSV) and human |
|
| July 22, 2025 |
Sanofi’s SAR446597 earns fast track designation in the US for geographic atrophy due to EX-99.1 Exhibit 99.1 Press Release Sanofi’s SAR446597 earns fast track designation in the US for geographic atrophy due to age-related macular degeneration • Designation earned for a one-time intravitreal gene therapy designed to inhibit two key complement cascade pathways • Geographic atrophy is an advanced form of dry age-related macular degeneration, that can lead to permanent vision loss Paris |
|
| July 18, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE TO Tender Offer Statement under Section 14(d)(1) or 13(e)(1) of the Securities Exchange Act of 1934 (Amendment No. 3) Blueprint Medicines Corporation (Name of Subject Company (Issuer)) ROTHKO MERGER SUB, INC. AVENTIS INC. SANOFI (Names of Filing Persons — Offerors) Common Stock, Par Value $0.001 Per Share (Title of Cl |
|
| July 18, 2025 |
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 2025 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) In |
|
| July 18, 2025 |
Exhibit 99.1 Press Release Sanofi completes acquisition of Blueprint Medicines Paris, July 18, 2025. Sanofi today announces the completion of its acquisition of Blueprint Medicines Corporation (Blueprint), adding to its portfolio a commercialized medicine, a promising pipeline, and the expertise of a company specializing in systemic mastocytosis (SM), a rare immunological disease, and other KIT-dr |
|
| July 17, 2025 |
Sanofi announces extension of Blueprint tender offer EX-99.(a)(5)(I) Exhibit (a)(5)(I) Press Release Sanofi announces extension of Blueprint tender offer Paris, July 17, 2025. Sanofi today announces that Rothko Merger Sub, Inc., a wholly owned subsidiary of Sanofi, has extended the expiration date of its tender offer to purchase all of the outstanding shares of common stock, par value $0.001 per share of Blueprint Medicines Corporation for $129.00 p |
|
| July 17, 2025 |
SC TO-T/A UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE TO Tender Offer Statement under Section 14(d)(1) or 13(e)(1) of the Securities Exchange Act of 1934 (Amendment No. 2) Blueprint Medicines Corporation (Name of Subject Company (Issuer)) ROTHKO MERGER SUB, INC. AVENTIS INC. SANOFI (Names of Filing Persons — Offerors) Common Stock, Par Value $0.001 Per Share (T |
|
| July 10, 2025 |
SC TO-T/A UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE TO Tender Offer Statement under Section 14(d)(1) or 13(e)(1) of the Securities Exchange Act of 1934 (Amendment No. 1) Blueprint Medicines Corporation (Name of Subject Company (Issuer)) ROTHKO MERGER SUB, INC. AVENTIS INC. SANOFI (Names of Filing Persons — Offerors) Common Stock, Par Value $0.001 Per Share (T |
|
| July 2, 2025 |
Riliprubart earns orphan drug designation in the US for Exhibit 99.1 Press Release Riliprubart earns orphan drug designation in the US for antibody-mediated rejection in solid organ transplantation • Ongoing phase 2 study evaluating riliprubart for the potential prevention and treatment of active antibody-mediated rejection in kidney transplant recipients • Riliprubart was also designated orphan drug for the investigational use in chronic inflammatory |
|
| July 2, 2025 |
Riliprubart granted orphan drug designation in Japan for Exhibit 99.2 Press Release Riliprubart granted orphan drug designation in Japan for chronic inflammatory demyelinating polyneuropathy • Two phase 3 studies are currently underway testing riliprubart in people with CIDP as a potential first-in-class treatment • Japanese Ministry of Health, Labour and Welfare decision adds to similar designations in the US and Europe, underscoring global regulatory |
|
| July 2, 2025 |
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 2025 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) In |
|
| June 27, 2025 |
United States Securities and Exchange Commission Washington, D.C. 20549 Form 11-K United States Securities and Exchange Commission Washington, D.C. 20549 Form 11-K (Mark One) x Annual Report Pursuant to Section 15(d) of the Securities Exchange Act of 1934. For the fiscal year ended December 31, 2024 OR ¨ Transition Report Pursuant to Section 15(d) of the Securities Exchange Act of 1934. (No fee required) For the transition period from to Commission File Number 1-18378 A. Full t |
|
| June 27, 2025 |
United States Securities and Exchange Commission Washington, D.C. 20549 United States Securities and Exchange Commission Washington, D.C. 20549 Form 11-K (Mark One) x Annual Report Pursuant to Section 15(d) of the Securities Exchange Act of 1934. For the fiscal year ended December 31, 2024 OR x Transition Report Pursuant to Section 15(d) of the Securities Exchange Act of 1934. (No fee required) For the transition period from to Commission File Number 1-18378 A. Full t |
|
| June 24, 2025 |
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 June 2025 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) In |
|
| June 24, 2025 |
Exhibit 99.3 Press Release Sarclisa recommended for EU approval by the CHMP to treat transplant-eligible newly diagnosed multiple myeloma • Recommendation based on GMMG-HD7 phase 3 study demonstrating that Sarclisa with VRd induction treatment significantly improved MRD negativity benefit and prolonged PFS compared to VRd alone • If approved, it would represent the fourth indication in the EU and |
|
| June 24, 2025 |
Dupixent approved in the US as the only targeted medicine to treat patients with bullous pemphigoid EX-99.2 Exhibit 99.2 Press Release Dupixent approved in the US as the only targeted medicine to treat patients with bullous pemphigoid • Approval based on pivotal results showing improvements in sustained disease remission and reductions in itch and oral corticosteroid use compared to placebo in adults with BP • BP is a chronic, debilitating, and relapsing rare skin disease affecting approximately |
|
| June 24, 2025 |
Exhibit 99.1 Press Release EAACI: Dupixent demonstrated superiority over Xolair (omalizumab) in chronic rhinosinusitis with nasal polyps in patients with coexisting asthma in first-ever presented phase 4 head-to-head respiratory study • New late-breaking data at EAACI showed Dupixent outperformed Xolair across all primary and secondary efficacy endpoints of CRSwNP and in all asthma-related endpoin |
|
| June 18, 2025 |
Sanofi successfully prices €1.5 billion bond issue EX-99.1 Exhibit 99.1 Press Release Sanofi successfully prices €1.5 billion bond issue Paris, June 17, 2025 - Sanofi announces that it has successfully priced its offering of €1.5 billion of notes across 2 tranches: - €750 million fixed-rate notes, due June 2029, bearing interest at an annual rate of 2.625%. - €750 million fixed-rate notes, due June 2032, bearing interest at an annual rate of 3.000 |
|
| June 18, 2025 |
6-K 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 June 2025 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 |
|
| June 17, 2025 |
Table 1: Transaction Valuation Calculation of Filing Fee Tables Table 1: Transaction Valuation Transaction Valuation Fee Rate Amount of Filing Fee Fees to be Paid 1 $ 9,570,172,566. |
|
| June 17, 2025 |
EX-99.1 Exhibit 99.1 Press Release Sanofi accelerates global shipping of Beyfortus to prepare healthcare providers months ahead of 2025-2026 RSV season Paris, June 9, 2025. Sanofi is shipping Beyfortus (nirsevimab) starting in early Q3 to ensure broad availability well ahead of the 2025-2026 respiratory syncytial virus (RSV) season, which typically starts in November and runs through March. Immuni |
|
| June 17, 2025 |
Exhibit (a)(1)(C) Offer to Purchase All Outstanding Shares of Common Stock of BLUEPRINT MEDICINES CORPORATION at $129. |
|
| June 17, 2025 |
Exhibit (d)(2) CONFIDENTIALITY AGREEMENT This Confidentiality Agreement (the “Agreement”) is made on this 24th day of May, 2024 (the “Effective Date”) by and between: SANOFI, a French corporation, with a principal office at 46, avenue de la Grande Armée, 75017 Paris, France (“Sanofi”), and, BLUEPRINT MEDICINES CORPORATION, a Delaware corporation, with a principal office at 45 Sidney Street, Cambridge, Massachusetts 02139, United States (“Blueprint”). |
|
| June 17, 2025 |
Amendment No. 1 to Confidentiality Agreement Exhibit (d)(3) Amendment No. 1 to Confidentiality Agreement This Amendment No. 1 (this “Amendment”), dated as of November 5, 2024 (“Amendment Effective Date”), between Blueprint Medicines Corporation (“Blueprint”) and SANOFI (“Sanofi”) amends that certain Confidentiality Agreement, dated May 24, 2024, between Sanofi and Blueprint (the “Agreement”). Sanofi and Blueprint are each referred to herein |
|
| June 17, 2025 |
6-K 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 June 2025 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 |
|
| June 17, 2025 |
EX-99.(a)(1)(F) Exhibit (a)(1)(F) This announcement is neither an offer to purchase nor a solicitation of an offer to sell Shares (as defined below). The Offer (as defined below) is made solely pursuant to the Offer to Purchase, dated June 17, 2025, and the related Letter of Transmittal and any amendments or supplements to such Offer to Purchase or Letter of Transmittal, and is being made to all h |
|
| June 17, 2025 |
SC TO-T UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE TO Tender Offer Statement under Section 14(d)(1) or 13(e)(1) of the Securities Exchange Act of 1934 Blueprint Medicines Corporation (Name of Subject Company (Issuer)) ROTHKO MERGER SUB, INC. AVENTIS INC. SANOFI (Names of Filing Persons — Offerors) Common Stock, Par Value $0.001 Per Share (Title of Class of Sec |
|
| June 17, 2025 |
Amendment No. 2 to Confidentiality Agreement Exhibit (d)(4) Amendment No. 2 to Confidentiality Agreement This Amendment No. 2 (this “Amendment No. 2”), dated as of May 17, 2025 (“Amendment No. 2 Effective Date”), between Blueprint Medicines Corporation (“Blueprint”) and SANOFI (“Sanofi”) amends that certain Confidentiality Agreement, dated May 24, 2024, between Sanofi and Blueprint (the “Agreement”), as amended by Amendment No. 1, dated as o |
|
| June 17, 2025 |
EX-99.(a)(1)(A) Table of Contents Exhibit (a)(1)(A) Offer To Purchase All Outstanding Shares of Common Stock of BLUEPRINT MEDICINES CORPORATION at $129.00 Per Share in cash, plus one contingent value right per share representing the right to receive certain contingent payments of up to an aggregate amount of $6.00 per Share in cash upon the achievement of specified milestones on or prior to the ex |
|
| June 17, 2025 |
EX-99.(a)(1)(D) Exhibit (a)(1)(D) Offer to Purchase All Outstanding Shares of Common Stock of BLUEPRINT MEDICINES CORPORATION at $129.00 PER SHARE IN CASH, PLUS ONE CONTINGENT VALUE RIGHT PER SHARE REPRESENTING THE RIGHT TO RECEIVE CONTINGENT PAYMENTS OF UP TO AN AGGREGATE AMOUNT OF $6.00 PER SHARE IN CASH UPON THE ACHIEVEMENT OF SPECIFIED MILESTONES ON OR PRIOR TO THE EXPIRATION OF THE APPLICABLE |
|
| June 17, 2025 |
EX-99.(a)(1)(E) Exhibit (a)(1)(E) Notice of Guaranteed Delivery With Respect to the Offer to Purchase All Outstanding Shares of Common Stock of BLUEPRINT MEDICINES CORPORATION at $129.00 PER SHARE IN CASH, PLUS ONE CONTINGENT VALUE RIGHT PER SHARE REPRESENTING THE RIGHT TO RECEIVE CONTINGENT PAYMENTS OF UP TO AN AGGREGATE AMOUNT OF $6.00 PER SHARE IN CASH UPON THE ACHIEVEMENT OF SPECIFIED MILESTON |
|
| June 17, 2025 |
EX-99.(d)(5) Exhibit (d)(5) Execution Version STRICTLY PRIVATE AND CONFIDENTIAL Blueprint Medicines Corporation 38 Sidney Street, Suite 200 Cambridge, MA 02139 United States Attention: Kate Haviland President and Chief Executive Officer May 18, 2025 Re: Project Rothko – Exclusivity Agreement Ladies and Gentlemen: In connection with the consideration by Sanofi of a potential acquisition of Blueprin |
|
| June 17, 2025 |
EX-99.(a)(1)(B) Exhibit (a)(1)(B) LETTER OF TRANSMITTAL To Tender Shares of Common Stock of BLUEPRINT MEDICINES CORPORATION at $129.00 PER SHARE IN CASH, PLUS ONE CONTINGENT VALUE RIGHT PER SHARE REPRESENTING THE RIGHT TO RECEIVE CONTINGENT PAYMENTS OF UP TO AN AGGREGATE AMOUNT OF $6.00 PER SHARE IN CASH UPON THE ACHIEVEMENT OF SPECIFIED MILESTONES ON OR PRIOR TO THE EXPIRATION OF THE APPLICABLE M |
|
| June 6, 2025 |
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 June 2025 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) In |
|
| June 6, 2025 |
Rilzabrutinib granted orphan drug designation in the US for sickle cell disease Exhibit 99.1 Press Release Rilzabrutinib granted orphan drug designation in the US for sickle cell disease • Fourth orphan drug designation for rilzabrutinib in rare diseases • Under regulatory review in the US, the EU, and China in immune thrombocytopenia Paris, June 3, 2025. The US Food and Drug Administration (FDA) has granted orphan drug designation to rilzabrutinib, a novel, advanced, oral, r |
|
| June 6, 2025 |
Sanofi Launches 2025 Global Employee Stock Purchase Plan Exhibit 99.3 Press Release Sanofi Launches 2025 Global Employee Stock Purchase Plan Paris, June 5, 2025. Sanofi’s global employee shareholder plan, Action 2025, opens on June 10, 2025, to around 70,000 employees in 55 countries. Now in its 11th year, the program demonstrates the ongoing commitment of Sanofi and its Board of Directors to involve employees in the company’s growth and results. In 202 |
|
| June 6, 2025 |
ASCO: new Sarclisa data support subcutaneous administration with Exhibit 99.2 Press Release ASCO: new Sarclisa data support subcutaneous administration with on-body injector • New data from two clinical studies demonstrated that Sarclisa administered subcutaneously via an investigational on-body injector shortened treatment time to minutes with similar efficacy and safety compared to intravenous infusion • Studies used Enable Injections’ enFuse® on-body injecto |
|
| June 3, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE TO Tender Offer Statement under Section 14(d)(1) or 13(e)(1) of the Securities Exchange Act of 1934 Blueprint Medicines Corporation (Name of Subject Company) ROTHKO MERGER SUB, INC. AVENTIS INC. SANOFI (Names of Filing Persons — Offerors) Common Stock, Par Value $0.001 Per Share (Title of Class of Securities) 09627Y10 |
|
| June 3, 2025 |
EX-99.1 Exhibit 99.1 |
|
| June 2, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE TO Tender Offer Statement under Section 14(d)(1) or 13(e)(1) of the Securities Exchange Act of 1934 Blueprint Medicines Corporation (Name of Subject Company) ROTHKO MERGER SUB, INC. AVENTIS INC. SANOFI (Names of Filing Persons — Offerors) Common Stock, Par Value $0.001 Per Share (Title of Class of Securities) 09627Y10 |
|
| June 2, 2025 |
Exhibit 99.2 Viva Engage Post from Houman Ashrafian to Sanofi R&D Organization Timing: Monday, June 2, 12:00pm CET / 6:00am ET Important Notices regarding Forward Looking Statements and Additional Information for US Shareholders Dear colleagues, This morning, we announced that we’ve entered into an agreement to acquire Blueprint Medicines, significantly enhancing our position in rare diseases and |
|
| June 2, 2025 |
6-K 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 June 2025 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 |
|
| June 2, 2025 |
EX-99.1 Exhibit 99.1 Press Release Sanofi to acquire Blueprint Medicines, expanding portfolio in rare immunological disease and adding early-stage pipeline in immunology • Adds fast-growing and only approved medicine for advanced and indolent systemic mastocytosis to the Sanofi portfolio Paris and Cambridge, MA. June 2, 2025. Sanofi and Blueprint Medicines Corporation (Blueprint), a US-based, publ |
|
| June 2, 2025 |
Exhibit 99.1 Viva Engage Post from Brian Foard to Message to Specialty Care employees Timing: Monday, June 2, 07:10am CET / 01:10am ET Important Notices regarding Forward Looking Statements and Additional Information for US Shareholders Dear colleagues, Today we signed an agreement to acquire Blueprint Medicines, a global pharmaceutical focused in systemic mastocytosis, a rare immunological diseas |
|
| June 2, 2025 |
EX-99.5 Exhibit 99.5 |
|
| June 2, 2025 |
Acquisition of Blueprint in rare diseases June 2, 2025 Exhibit 99.4 Acquisition of Blueprint in rare diseases June 2, 2025 Forward-looking statements This communication contains forward-looking statements that are subject to risks, uncertainties and other factors that could cause actual results to differ materially from those implied by the forward-looking statements. Forward-looking statements are statements that are not historical facts and may incl |
|
| June 2, 2025 |
Exhibit 99.3 LinkedIn Post: X Post: |
|
| June 2, 2025 |
EX-99.1 Exhibit 99.1 Press Release Sanofi to acquire Blueprint Medicines, expanding portfolio in rare immunological disease and adding early-stage pipeline in immunology • Adds fast-growing and only approved medicine for advanced and indolent systemic mastocytosis to the Sanofi portfolio Paris and Cambridge, MA. June 2, 2025. Sanofi and Blueprint Medicines Corporation (Blueprint), a US-based, publ |
|
| June 2, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE TO Tender Offer Statement under Section 14(d)(1) or 13(e)(1) of the Securities Exchange Act of 1934 Blueprint Medicines Corporation (Name of Subject Company) ROTHKO MERGER SUB, INC. AVENTIS INC. SANOFI (Names of Filing Persons — Offerors) Common Stock, Par Value $0.001 Per Share (Title of Class of Securities) 09627Y10 |
|
| June 2, 2025 |
EX-99.6 Exhibit 99.6 02-Jun-2025 Sanofi (SNY) Investor Relations Call: Acquisition of Blueprint Medicines by Sanofi Thomas: Good morning, everyone. This is Thomas Kudsk Larsen from the Sanofi IR team. Thank you for joining us today to discuss Sanofi’s proposed acquisition of Blueprint Medicines that significantly strengthens our position in rare diseases and which represents a major step forward i |
|
| May 30, 2025 |
Itepekimab met the primary endpoint in one of two COPD phase 3 studies Exhibit 99.3 Press Release Itepekimab met the primary endpoint in one of two COPD phase 3 studies • AERIFY-1 study met its primary endpoint of a statistically significant reduction in moderate or severe exacerbations in former smokers regardless of eosinophilic phenotype and provided a clinically meaningful benefit • AERIFY-2 study, a second Phase 3 study, did not meet the primary endpoint despite |
|
| May 30, 2025 |
Exhibit 99.2 Press Release Beyfortus public health advantage bolstered by first real- world comparison of infant vs maternal RSV immunization programs • Late-breaking data show infant respiratory syncytial virus (RSV) hospitalizations reduced by 69% in Spain following Beyfortus-only immunization targeted to all infants and 26.7% in the UK following RSVpreF-only maternal vaccination • Newly present |
|
| May 30, 2025 |
Sanofi completes acquisition of DR-0201 EX-99.1 Exhibit 99.1 Press Release Sanofi completes acquisition of DR-0201 Paris, May 27, 2025. Sanofi announces the completion of its acquisition of DR-0201, a targeted bispecific myeloid cell engager, from Dren Bio, Inc., a private clinical-stage biopharmaceutical company. The acquisition bolsters Sanofi’s ambition to become the foremost immunology company and broadens the company’s leading immu |
|
| May 30, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the month of May 2025 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) Ind |
|
| May 22, 2025 |
EX-99.1 Exhibit 99.1 Press Release Sanofi to acquire Vigil Neuroscience, Inc., adding a new investigational medicine to treat Alzheimer’s disease to the neurology pipeline Paris, May 22, 2025. Sanofi announced today that it has entered into an agreement to acquire Vigil Neuroscience, Inc. (“Vigil”), a publicly traded clinical-stage biotechnology company focused on developing novel therapies for ne |
|
| May 22, 2025 |
6-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the month of May 2025 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) |
|
| May 21, 2025 |
SD UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM SD Specialized Disclosure Report SANOFI (Exact name of registrant as specified in its charter) Republic of France 001-31368 98-0346613 (State or other jurisdiction (Commission (IRS Employer of incorporation or organization) File Number) Identification No.) 46 avenue de la Grande Armée Paris, France 75017 (Address of pr |
|
| May 5, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the month of May 2025 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) Ind |
|
| May 5, 2025 |
Annual General Meeting of April 30, 2025 Exhibit 99.1 Press Release Annual General Meeting of April 30, 2025 • Approval of the financial statements for the fiscal year 2024 • Distribution of a cash dividend of €3.92 per share, with payment as of May 14, 2025 • Board composition: renewal of four Directors and ratification of the cooptation of Jean-Paul Kress Paris, April 30, 2025. The Combined General Shareholders’ Meeting of Sanofi was h |
|
| April 30, 2025 |
Sanofi and CD&R close Opella transaction, create global consumer healthcare leader Exhibit 99.1 Press Release Sanofi and CD&R close Opella transaction, create global consumer healthcare leader Paris, April 30, 2025. Opella today becomes an independent global leader in consumer healthcare, marking a pivotal step in Sanofi’s strategy. Sanofi announces today the closing of the sale to CD&R of a 50.0% controlling stake of its consumer healthcare business Opella. Sanofi retains a sig |
|
| April 30, 2025 |
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 April 2025 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) I |
|
| April 24, 2025 |
Press Release Sanofi: strong Q1 performance and 2025 guidance confirmed Paris, April 24, 2025 Q1 sales growth of 9. |
|
| April 24, 2025 |
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 April 2025 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) I |
|
| April 22, 2025 |
6-K 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 April 2025 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 office |
|
| April 22, 2025 |
Exhibit 99.1 Press Release Dupixent approved in the US as the first new targeted therapy in over a decade for chronic spontaneous urticaria • Approval based on phase 3 studies demonstrating Dupixent significantly reduced itch and hives compared to placebo • In the US, there are more than 300,000 adults and adolescents aged 12 years and older living with CSU who remain symptomatic despite antihista |
|
| April 16, 2025 |
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 April 2025 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) I |
|
| April 16, 2025 |
EX-99.1 Exhibit 99.1 Press Release Sanofi’s respiratory pipeline advances with new data in asthma and plans for new clinical studies in COPD • New phase 2 data for amlitelimab show efficacy in heterogeneous inflammatory asthma • Lunsekimig now targeting chronic rhinosinusitis and COPD in addition to asthma • Itepekimab expanding into chronic rhinosinusitis along with COPD and bronchiectasis; phase |
|
| April 10, 2025 |
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 April 2025 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) I |
|
| April 10, 2025 |
EX-99.1 Exhibit 99.1 Press Release Tolebrutinib phase 3 data published in NEJM demonstrate benefit on disability progression in multiple sclerosis • Results from the HERCULES phase 3 study showed delay in disability progression in people living with non-relapsing secondary progressive multiple sclerosis • Tolebrutinib has the potential to be the first therapy to modulate immunologic drivers of chr |
|
| April 4, 2025 |
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 April 2025 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) I |
|
| April 4, 2025 |
EX-99.1 Exhibit 99.1 Press Release Rilzabrutinib granted orphan drug designation in the US for two rare diseases with no approved medicines • Designation granted for warm autoimmune hemolytic anemia and IgG4-related disease • Rilzabrutinib is currently under regulatory review in the US, EU and China for potential use in immune thrombocytopenia Paris, April 3, 2025. The US Food and Drug Administrat |
|
| April 2, 2025 |
Dupixent approved as the first-ever biologic medicine in Japan for patients with COPD EX-99.1 2 d913001dex991.htm EX-99.1 Exhibit 99.1 Press Release Dupixent approved as the first-ever biologic medicine in Japan for patients with COPD • Following recent approvals in the EU, China, and the US, this approval was based on pivotal phase 3 results in adults with elevated eosinophils • Approval marks the first new treatment approach for COPD in more than a decade in Japan and the sixth a |
|
| April 2, 2025 |
Exhibit 99.2 Press Release Qfitlia approved as the first therapy in the US to treat hemophilia A or B with or without inhibitors • Qfitlia (fitusiran), the first antithrombin-lowering therapy in hemophilia, offers consistent protection with as few as six injections a year via a prefilled pen or vial and syringe • Unique mechanism helps reduce the frequency of bleeding episodes for people with hemo |
|
| April 2, 2025 |
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 April 2025 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) I |
|
| March 27, 2025 |
As filed with the Securities and Exchange Commission on March 27, 2025 As filed with the Securities and Exchange Commission on March 27, 2025 Registration No. |
|
| March 27, 2025 |
Terms of the Action 2025 Shareholding Plan EX-4.5 2 d941880dex45.htm EX-4.5 Exhibit 4.5 Terms of the Action 2025 Shareholding Plan The following is a summary of the terms and conditions of a “classic” employee share offering under which Sanofi, a French company listed on Euronext Paris (the Paris stock exchange) would offer shares to its group employees. Type of offering: “Classic” plan only. The offering of shares will be made pursuant to |
|
| March 27, 2025 |
Exhibit 107 Calculation of Filing Fee Tables Form S-8 (Form Type) SANOFI (Exact Name of Registrant as Specified in its Charter) Table 1: Newly Registered Securities Security Type Security Class Title Fee Calculation Rule Amount Registered Proposed Maximum Offering Price Per Unit Maximum Aggregate Offering Price Fee Rate Amount of Registration Fee Equity Ordinary Shares, par value €2. |
|
| March 26, 2025 |
Chlamydia vaccine candidate granted fast track designation by the US FDA Exhibit 99.2 Press Release Chlamydia vaccine candidate granted fast track designation by the US FDA • Chlamydia infection can contribute to pelvic inflammatory diseases in women, which can lead to pregnancy complications or infertility • A phase 1/2 clinical study evaluating the immunogenicity and safety of the vaccine candidate is due to start in coming days Paris, March 26, 2025. The US Food and |
|
| March 26, 2025 |
Exhibit 99.1 Press Release Tolebrutinib regulatory submission accepted for priority review in the US for patients with multiple sclerosis • If approved, tolebrutinib would be the first and only brain-penetrant BTK inhibitor to both treat non-relapsing secondary progressive multiple sclerosis (MS) and slow disability accumulation independent of relapse activity • Tolebrutinib has the potential to b |
|
| March 26, 2025 |
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 March 2025 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) I |
|
| March 21, 2025 |
As filed with the Securities and Exchange Commission on March 21, 2025 As filed with the Securities and Exchange Commission on March 21, 2025 Registration No. |
|
| March 20, 2025 |
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 March 2025 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) I |
|
| March 20, 2025 |
Sanofi to acquire Dren Bio’s bispecific myeloid cell engager for deep EX-99.1 Exhibit 99.1 Press Release Sanofi to acquire Dren Bio’s bispecific myeloid cell engager for deep B-cell depletion, broadening immunology pipeline • Dren Bio deep B-cell depleter program has the potential to reset the immune system • Acquisition underpins path for Sanofi becoming leading immunology company • Sanofi to pay $600 million up front Paris, March 20, 2025. Sanofi and Dren Bio, Inc |
|
| March 10, 2025 |
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 March 2025 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) I |
|
| March 10, 2025 |
Dupixent late-breaking positive pivotal data in bullous pemphigoid presented at AAD Exhibit 99.1 Press Release Dupixent late-breaking positive pivotal data in bullous pemphigoid presented at AAD • Five times more adults on Dupixent achieved sustained disease remission at 36 weeks compared to placebo; significant reductions were also seen in disease severity and itch • Dupixent also significantly reduced oral corticosteroid and rescue medicine use compared to placebo • Data suppor |
|
| March 6, 2025 |
Sanofi successfully prices EUR 1.5 billion of bond issue Exhibit 99.1 Press Release Sanofi successfully prices EUR 1.5 billion of bond issue Paris, March 5, 2025. Sanofi announces that it has successfully priced its offering of EUR 1.5 billion of notes across 2 tranches: • €850 million floating rate notes, due March 2027, bearing interest at 3-month Euribor plus 0.300% • €650 million fixed rate notes, due March 2031, bearing interest at an annual rate |
|
| March 6, 2025 |
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 March 2025 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) I |
|
| February 28, 2025 |
Sarclisa approved in Japan for patients with newly diagnosed multiple myeloma Exhibit 99.2 Press Release Sarclisa approved in Japan for patients with newly diagnosed multiple myeloma • Approval offers access to new treatment options for newly diagnosed MM patients • Approval based on positive results from the IMROZ phase 3 study that demonstrated Sarclisa in combination with VRd significantly improved progression-free survival, compared to VRd alone in transplant-ineligible |
|
| February 28, 2025 |
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 February 2025 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 |
|
| February 28, 2025 |
ECCO 2025: new duvakitug data reinforce Exhibit 99.1 Press Release ECCO 2025: new duvakitug data reinforce best-in-class potential in ulcerative colitis and Crohn’s disease • New detailed data from the RELIEVE UCCD study support overall efficacy and safety of duvakitug in all pre-specified subgroups across the different doses • New endpoints presented include findings on clinical and endoscopic outcomes and histological-endoscopic mucos |
|
| February 20, 2025 |
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 February 2025 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 |
|
| February 20, 2025 |
Sanofi and CD&R sign Opella share purchase agreement Exhibit 99.2 Press Release Sanofi and CD&R sign Opella share purchase agreement Paris, February 19, 2025. Following completion of the required social and corporate procedures, Sanofi and CD&R announce today they have signed the share purchase agreement in relation to the sale of a 50% controlling stake in Opella to CD&R. Bpifrance is expected to participate as a minority shareholder with a c.2% st |
|
| February 20, 2025 |
Dupixent sBLA accepted for FDA priority review for the targeted treatment of bullous pemphigoid Exhibit 99.1 Press Release Dupixent sBLA accepted for FDA priority review for the targeted treatment of bullous pemphigoid • If approved, Dupixent would be the first and only targeted medicine to treat BP in the US; FDA decision expected by June 20, 2025 • Priority review granted based on positive pivotal results demonstrating significant improvements in sustained disease remission with Dupixent c |
|
| February 13, 2025 |
Exhibit 4.1 SHARE BUYBACK AGREEMENT BETWEEN SANOFI AND L'OREAL 1. BETWEEN -Sanofi, a société anonyme, organized under the laws of France, with share capital of 2,526,245,442 euros, having its registered office in France at 46 avenue de la Grande Armée, Paris (75017), and registered with the Paris Trade and Companies Registry under number 395 030 844. (hereinafter referred to as "Sanofi"), AND -L'O |
|
| February 13, 2025 |
Exhibit 13.2 Pursuant to section 906 of the Sarbanes-Oxley Act of 2002 (subsections (a) and (b) of section 1350, Chapter 63 of Title 18, United States Code), the undersigned officer of Sanofi, a French société anonyme (the “Company”), does hereby certify, to such officer’s knowledge, that: The annual report on Form 20-F for the year ended December 31, 2024 (the “Form 20-F”) of the Company fully co |
|
| February 13, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 20-F (Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 Or ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 Or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXC |
|
| February 13, 2025 |
I, François-Xavier Roger, certify that: Exhibit 12.2 I, François-Xavier Roger, certify that: 1. I have reviewed this annual report on Form 20-F of Sanofi; 2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered |
|
| February 13, 2025 |
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 February 2025 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 |
|
| February 13, 2025 |
CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM Exhibit 15.1 CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM We hereby consent to the incorporation by reference in the Registration Statements on Form S-8 (No. 333-278502) and on Form F-3 (No. 333-278506) of Sanofi of our reports dated February 13, 2025, relating to the financial statements as of and for the year ended December 31, 2024, and the effectiveness of internal control over fin |
|
| February 13, 2025 |
Exhibit 13.1 Pursuant to section 906 of the Sarbanes-Oxley Act of 2002 (subsections (a) and (b) of section 1350, Chapter 63 of Title 18, United States Code), the undersigned officer of Sanofi, a French société anonyme (the “Company”), does hereby certify, to such officer’s knowledge, that: The annual report on Form 20-F for the year ended December 31, 2024 (the “Form 20-F”) of the Company fully co |
|
| February 13, 2025 |
CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM Exhibit 15.2 CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM We hereby consent to the incorporation by reference in the Registration Statements on Form S-8 (No. 333-278502) and on Form F-3 (No. 333-278506) of Sanofi of our reports dated February 13, 2025 relating to the financial statements and the effectiveness of internal control over financial reporting, which appear in this Form 20-F. |
|
| February 13, 2025 |
DESCRIPTION OF SECURITIES REGISTERED UNDER SECTION 12 OF THE EXCHANGE ACT Exhibit 2.2 DESCRIPTION OF SECURITIES REGISTERED UNDER SECTION 12 OF THE EXCHANGE ACT Introduction As of December 31, 2024, Sanofi (“Sanofi,” “we,” “us,” and “our”) had the following series of securities registered pursuant to Section 12(b) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Title of Each Class Trading Symbol Name of each exchange on which registered American |
|
| February 13, 2025 |
CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM Exhibit 15.3 CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM We hereby consent to the incorporation by reference in the Registration Statements on Form S-8 (No. 333-278502) and on Form F-3 (No. 333-278506) of our report dated February 23, 2024, with respect to the consolidated financial statements of Sanofi S.A. and its subsidiaries (the “Group”) as of and for the years ended December 31, |
|
| February 13, 2025 |
Exhibit 12.1 I, Paul Hudson, certify that: 1. I have reviewed this annual report on Form 20-F of Sanofi; 2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this r |
|
| February 13, 2025 |
Update on extraintestinal pathogenic E. coli vaccine phase 3 clinical study Exhibit 99.1 Press Release Update on extraintestinal pathogenic E. coli vaccine phase 3 clinical study • Independent interim analysis of the E.mbrace phase 3 study finds that the vaccine candidate didn’t demonstrate sufficient efficacy in preventing invasive E. coli disease • No safety signals related to the vaccine candidate were identified Paris, February 13, 2025. A scheduled review of the E.mb |
|
| February 13, 2025 |
Exhibit 1.1 SANOFI Limited liability company (Société Anonyme à conseil d’administration) Registered capital : €2,529,599,938 Registered office : 46 avenue de la Grande Armée – 75017 Paris Registration number : PARIS 395 030 844 ARTICLES OF ASSOCIATION This text is a free translation from the French language and is supplied solely for information purposes. Only the original version in the French l |
|
| February 13, 2025 |
Exhibit 11.1 GLOBAL OPERATING PROCEDURE Prevention of Insider Trading 1.PURPOSE This Global Operating Procedure (GOP) is designed for the prevention of improper trading in Securities of Sanofi or in Securities of Sanofi’s business partners by Sanofi and its subsidiaries and their respective employees, executive officers and directors and the members of the foregoing persons’ immediate families and |
|
| February 7, 2025 |
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 February 2025 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 |
|
| February 7, 2025 |
Execution of a share buyback agreement for up to €2 billion Exhibit 99.1 Press Release Execution of a share buyback agreement for up to €2 billion Paris, February 7, 2025. On January 30, 2025, Sanofi announced its intention to execute a share buyback program in 2025 of €5 billion, preferably through block trades and in the open market with the purpose of cancellation. A first tranche of this program was announced on February 3, 2025, and executed on Februa |
|
| February 3, 2025 |
Sanofi announces buy back of shares from L’Oréal Exhibit 99.2 Press Release Sanofi announces buy back of shares from L’Oréal Paris, February 3, 2025. Sanofi today announces the acquisition of 2.3% of its shares from long-standing shareholder L’Oréal. This transaction is part of Sanofi’s share buyback program announced on January 30, 2025. It is fully aligned with Sanofi’s capital allocation policy and focus on sustainable value creation for shar |
|
| February 3, 2025 |
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 February 2025 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 |
|
| February 3, 2025 |
Sarclisa is the first anti-CD38 treatment in combination with Exhibit 99.1 Press Release Sarclisa is the first anti-CD38 treatment in combination with standard-of-care VRd approved in China for patients with newly diagnosed multiple myeloma ineligible for transplant • Approval based on positive results from the IMROZ phase 3 study that demonstrated Sarclisa in combination with bortezomib, lenalidomide, and dexamethasone (VRd) significantly improved progressi |
|
| January 30, 2025 |
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 January 2025 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) |
|
| January 30, 2025 |
Press Release Sanofi: Q4 sales growth of 10.3%, 2024 business EPS guidance exceeded, and strong business EPS rebound expected in 2025 Paris, January 30, 2025 Q4: sales growth of 10.3% at CER1 and business EPS2 of €1.31 •Pharma launches up 56.5%, reaching sales of €0.8 billion, 8% of total sales, led by ALTUVIIIO •Dupixent sales up 16.0% to €3.5 billion •Vaccines sales up 10.8% to €2.2 billion, dri |
|
| January 24, 2025 |
Sarclisa approved in the EU as the first anti-CD38 therapy in combination with Exhibit 99.2 Press Release Sarclisa approved in the EU as the first anti-CD38 therapy in combination with standard-of-care VRd to treat transplant-ineligible newly diagnosed multiple myeloma • Approval is based on positive results from the IMROZ phase 3 study, demonstrating Sarclisa in combination with standard-of-care treatment significantly improved PFS, compared to the standard of care alone in |
|
| January 24, 2025 |
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 January 2025 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) |
|
| January 24, 2025 |
Opella reaches study milestone for Cialis Exhibit 99.1 Press Release Opella reaches study milestone for Cialis Paris, January 21, 2025. Opella, Sanofi’s Consumer Healthcare business, announced that the US Food and Drug Administration (FDA) has lifted a clinical hold on its planned actual use trial (AUT) to support the switch of Cialis (tadalafil) from a prescription to an over-the-counter medicine. This decision allows for the initiation |
|
| January 14, 2025 |
New Sarclisa subcutaneous formulation met Exhibit 99.1 Press Release New Sarclisa subcutaneous formulation met co-primary endpoints in the IRAKLIA phase 3 study in multiple myeloma • Sarclisa SC formulation added to Pd for the treatment of R/R MM met the co-primary endpoints in the IRAKLIA phase 3 study, demonstrating non-inferiority compared to Sarclisa IV • IRAKLIA is the first global phase 3 study to evaluate the SC administration of a |
|
| January 14, 2025 |
Exhibit 99.2 Press Release Sarclisa obtains first approval in China for the treatment of adult patients with relapsed or refractory multiple myeloma • Approval based on positive pivotal ICARIA-MM phase 3 study using the China-based IsaFiRsT real-world study as bridging data, which demonstrated Sarclisa and the standard treatment Pd, improved responses and long-term outcomes compared to Pd alone in |
|
| January 14, 2025 |
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 January 2025 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) |
|
| December 23, 2024 |
Exhibit 99.2 Press Release Sanofi initiates phase 3 program for PCV21 and expands collaboration with SK bioscience for next-generation pneumococcal conjugate vaccines • Pneumococcal disease remains a major global health challenge despite the availability of current vaccines • This 21-valent pneumococcal conjugate vaccine (PCV21) is the first pneumococcal conjugate vaccine candidate with more than |
|
| December 23, 2024 |
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 |
|
| December 23, 2024 |
Jean-Paul Kress to join Sanofi’s Board of Directors 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 |
|
| December 20, 2024 |
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 |
|
| December 20, 2024 |
Tolebrutinib designated Breakthrough Therapy by the FDA Exhibit 99.1 Press Release Tolebrutinib designated Breakthrough Therapy by the FDA for non-relapsing secondary progressive multiple sclerosis • Designation is based on positive results from the HERCULES study in adults with non-relapsing secondary progressive multiple sclerosis (nrSPMS) • Tolebrutinib is the first and only brain-penetrant BTK inhibitor in MS to be designated Breakthrough Therapy b |
|
| December 20, 2024 |
Duvakitug positive phase 2b results demonstrate Exhibit 99.2 Press Release Duvakitug positive phase 2b results demonstrate best-in-class potential in ulcerative colitis and Crohn’s disease • Primary endpoints met in ulcerative colitis (UC) and Crohn’s disease (CD), the most common forms of inflammatory bowel disease (IBD) • Primary endpoint results in UC and CD for high dose represent the highest achieved with any TL1A monoclonal antibody • San |
|
| December 13, 2024 |
Two combination vaccine candidates for prevention of influenza and EX-99.4 Exhibit 99.4 Press Release Two combination vaccine candidates for prevention of influenza and COVID-19 granted Fast Track designation in the US • First non-mRNA combination vaccine candidates that include two already licensed vaccines to prevent influenza and COVID-19 infections • Two phase 1/2 clinical studies are ongoing to evaluate the safety profile and immune response induced by the c |
|
| December 13, 2024 |
6-K 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 off |
|
| December 13, 2024 |
EX-99.3 Exhibit 99.3 Press Release ASH: Sarclisa combinations demonstrated significant benefits in newly diagnosed multiple myeloma patients • New analysis from the IMROZ phase 3 study of Sarclisa-VRd demonstrated higher and sustained MRD negativity rates in transplant-ineligible NDMM patients versus VRd alone • New detailed results from the GMMG-HD7 phase 3 study of Sarclisa-RVd induction therapy |
|
| December 13, 2024 |
Availability of the profit and loss information of Sanofi excluding Opella EX-99.1 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” s |
|
| December 13, 2024 |
Exhibit 99.2 Press Release ASH: rilzabrutinib demonstrated significant patient benefit in the first positive phase 3 study of a BTK inhibitor in ITP • Pivotal phase 3 data show rapid and durable platelet response, reduced bleeding and need for rescue response, and improved physical fatigue and quality of life measures in patients with persistent or chronic ITP • Results underscore the safety and e |
|
| November 18, 2024 |
Exhibit 99.1 Press Release Sarclisa recommended for EU approval by the CHMP to treat transplant-ineligible newly diagnosed multiple myeloma • Recommendation based on IMROZ phase 3 study demonstrating Sarclisa in combination with VRd significantly improved progression-free survival, compared to standard-of-care VRd alone • If approved, Sarclisa would be the first anti-CD38 therapy in the EU availab |
|
| November 18, 2024 |
Dupixent sBLA accepted for FDA review for the treatment of chronic spontaneous urticaria Exhibit 99.2 Press Release Dupixent sBLA accepted for FDA review for the treatment of chronic spontaneous urticaria • Resubmission includes new pivotal data which confirm Dupixent significantly reduced itch and hive activity • More than 300,000 people in the US suffer from chronic spontaneous urticaria (CSU) that is inadequately controlled by antihistamines • FDA decision expected by April 18, 202 |
|
| November 18, 2024 |
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 November 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 |
|
| November 7, 2024 |
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 November 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 |
|
| November 7, 2024 |
Exhibit 99.1 Press Release Dupixent approved in the EU as the first and only medicine for young children with eosinophilic esophagitis • Approval based on phase 3 data showing significantly more children aged one to 11 years on Dupixent achieved histological disease remission at 16 weeks compared to placebo, which was sustained up to one year • Dupixent is the first-ever medicine in the EU indicat |
|
| November 7, 2024 |
SNY / Sanofi - Depositary Receipt (Common Stock) / Amundi - SCHEDULE 13GA Passive Investment SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 SCHEDULE 13G* (Rule 13d-102) INFORMATION TO BE INCLUDED IN STATEMENTS FILED PURSUANT TO RULES 13d-1(b), (c), AND (d) AND AMENDMENTS THERETO FILED PURSUANT TO RULE 13d-2 (AMENDMENT NO. 5 )* Name of issuer: Sanofi Title of Class of Securities: Common Stock and American Depositary Receipts CUSIP Number: Not Applicable** and 80105N105 Date of E |
|
| October 31, 2024 |
Exhibit 99.1 Press Release Dupixent late-breaking positive phase 3 data in chronic spontaneous urticaria to be presented at ACAAI ● Dupixent significantly reduced itch and hive activity from baseline; 41% of patients achieved well-controlled disease status ● Confirmatory data to support US regulatory resubmission by year-end; if approved, Dupixent would be the first new targeted treatment for peop |
|
| October 31, 2024 |
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) |
|
| October 25, 2024 |
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) |
|
| October 25, 2024 |
Press Release Sanofi Q3: 15.7% sales growth boosted by earlier-than-anticipated vaccine sales; 2024 business EPS guidance raised due to strong business performance Paris, October 25, 2024 Q3 sales growth of 15.7% at CER and business EPS(1) of €2.86 •Dupixent sales up 23.8% to €3,476 million; full-year 2024 target of ~€13 billion confirmed •Pharma launches up 67.1% to €727 million, led by ALTUVIIIO |
|
| October 21, 2024 |
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) |
|
| October 21, 2024 |
Sanofi and Orano join forces to develop next-generation radioligand medicines 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-gene |
|
| October 21, 2024 |
Sanofi and CD&R partner to fuel Opella’s ambitions in consumer healthcare Exhibit 99.2 Press Release Sanofi and CD&R partner to fuel Opella’s ambitions in consumer healthcare • Sanofi and CD&R enter exclusive negotiations to transfer a 50% controlling stake in Opella with Sanofi to remain a significant shareholder • With 11,000 talented and passionate people bringing iconic brands to life, Opella poised to ignite new bold development journey • Sanofi to become a focused |
|
| October 11, 2024 |
Exhibit 99.1 Press Release New Beyfortus data featured at IDWeek reinforce real-world effectiveness against RSV disease and hospitalization in infants Paris, October 9, 2024. Sanofi advances its ambition to protect all infants from respiratory syncytial virus (RSV) disease with new Beyfortus (nirsevimab) data to be presented at the Infectious Disease Society of America’s IDWeek 2024 annual meeting |
|
| October 11, 2024 |
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) |
|
| October 11, 2024 |
Sanofi in discussions to sell a controlling stake in Opella Exhibit 99.2 Press Release Sanofi in discussions to sell a controlling stake in Opella Paris, October 11, 2024. Sanofi today announces that the company has entered into negotiations with CD&R for the potential sale of a 50% controlling stake in Opella, its consumer healthcare business. Should these discussions lead to a positive outcome, any agreement would be subject to the completion of the nece |
|
| October 2, 2024 |
Dupixent approved in the US as the first-ever biologic medicine for patients with COPD Exhibit 99.2 Press Release Dupixent approved in the US as the first-ever biologic medicine for patients with COPD ● Dupixent is indicated for the approximately 300,000 adults in the US with inadequately controlled COPD and an eosinophilic phenotype ● Following recent approvals in the EU and China, the US approval is based on two landmark phase 3 studies that showed Dupixent achieved significant re |
|
| October 2, 2024 |
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) |
|
| October 2, 2024 |
Dupixent approved in China as the first-ever biologic medicine for patients with COPD Exhibit 99.1 Press Release Dupixent approved in China as the first-ever biologic medicine for patients with COPD ● Approval follows EU approval of Dupixent for adults with COPD with raised blood eosinophils, and is based on two landmark phase 3 studies showing Dupixent significantly reduced exacerbations, improved lung function, and also improved health-related quality of life ● COPD is the most p |
|
| September 24, 2024 |
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 September 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 office |
|
| September 24, 2024 |
Exhibit 99.2 Press Release Dupixent recommended for EU approval by the CHMP to treat eosinophilic esophagitis in children as young as 1 year old * Recommendation based on a phase 3 study showing a significantly greater proportion of children on Dupixent achieved histological remission, compared to placebo, consistent with improvements seen in adults and adolescents * If approved, Dupixent would be |
|
| September 24, 2024 |
Exhibit 99.1 Press Release Tolebrutinib demonstrated a 31% delay in time to onset of confirmed disability progression in non-relapsing secondary progressive multiple sclerosis phase 3 study • Data presented at ECTRIMS show that tolebrutinib, a brain-penetrant BTK inhibitor, addresses disability accumulation that occurs independently from relapse activity • Global regulatory submissions will begin |
|
| September 24, 2024 |
Sarclisa approved in the US as the first anti-CD38 therapy in combination with Exhibit 99.3 Press Release Sarclisa approved in the US as the first anti-CD38 therapy in combination with standard-of-care treatment for adult patients with newly diagnosed multiple myeloma not eligible for transplant • Approval based on positive results from the IMROZ phase 3 study demonstrating Sarclisa in combination with bortezomib, lenalidomide, and dexamethasone (VRd) significantly improved |
|
| September 13, 2024 |
Exhibit 99.1 Press Release Dupixent is the first and only biologic to achieve significant improvements in disease remission and symptoms in bullous pemphigoid positive pivotal study • Study met the primary and all key secondary endpoints in adults with moderate-to-severe disease; five times more patients achieved sustained disease remission with Dupixent than placebo • Dupixent is the first medici |
|
| September 13, 2024 |
Exhibit 99.3 Press Release Sanofi, RadioMedix, and Orano Med announce licensing agreement on next-generation radioligand medicine for rare cancers Paris, France, and Houston, Texas, September 12, 2024. As part of its effort to develop innovative treatments for people living with rare cancers, Sanofi has entered into an exclusive licensing agreement with RadioMedix, Inc., a US clinical-stage biotec |
|
| September 13, 2024 |
Dupixent phase 3 study confirms significant improvements in itch and hives for patients with CSU Exhibit 99.2 Press Release Dupixent phase 3 study confirms significant improvements in itch and hives for patients with CSU ● Confirming the results of CUPID-A, this second pivotal study in biologic-naïve patients met primary and key secondary endpoints, showing treatment with Dupixent resulted in a nearly 50% reduction in itch and urticaria activity scores compared to placebo ● More than 300,000 |
|
| September 13, 2024 |
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 September 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 office |
|
| September 3, 2024 |
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 September 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 office |
|
| September 3, 2024 |
Exhibit 99.1 Press Release Tolebrutinib meets primary endpoint in HERCULES phase 3 study, the first and only to show reduction in disability accumulation in non-relapsing secondary progressive multiple sclerosis ● In the HERCULES study, tolebrutinib met the primary endpoint in delaying time to onset of confirmed disability progression in people with nrSPMS, a population for which there are current |
|
| August 13, 2024 |
6-K 1 d835901d6k.htm 6-K 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 August 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 prin |
|
| August 13, 2024 |
MGTX / MeiraGTx Holdings plc / Sanofi - SC 13G/A Passive Investment SC 13G/A UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. 1)* MeiraGTx Holdings plc (Name of Issuer) Ordinary Shares, $0.00003881 par value per share (Title of Class of Securities) G59665 102 (CUSIP Number) August 12, 2024 (Date of Event Which Requires Filing of this Statement) Check the appropriate box to |
|
| August 13, 2024 |
Exhibit 99.1 Press Release Sarclisa induction treatment demonstrated significantly improved progression-free survival in patients with newly diagnosed multiple myeloma eligible for transplant ● Sarclisa (isatuximab) in combination with standard-of-care lenalidomide, bortezomib, and dexamethasone (RVd) during 18-week induction treatment followed by transplant resulted in a statistically significant |
|
| July 25, 2024 |
Exhibit 99.1 TABLE OF CONTENTS 1. CONDENSED HALF-YEAR CONSOLIDATED FINANCIAL STATEMENTS 2 CONSOLIDATED BALANCE SHEETS – ASSETS 2 CONSOLIDATED BALANCE SHEETS — SHAREHOLDERS’ EQUITY AND LIABILITIES 3 CONSOLIDATED INCOME STATEMENTS 4 CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME 5 CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY 6 CONSOLIDATED STATEMENTS OF CASH FLOWS 8 NOTES TO THE CONDENSED HALF-YEAR |
|
| July 25, 2024 |
Press Release Sanofi Q2: strong performance with 10% sales growth; 2024 guidance upgraded Paris, July 25, 2024 Q2 sales growth of 10. |
|
| July 25, 2024 |
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) In |
|
| July 25, 2024 |
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 (Address of principal executive offices) Indicate b |
|
| July 25, 2024 |
Exhibit 99.2 TABLE OF CONTENTS 2 HALF-YEAR MANAGEMENT REPORT 37 A/ Significant events of the first half of 2024 37 B/ Progress on implementation of the Corporate Social Responsibility strategy 40 C/ Events subsequent to June 30, 2024 43 D/ Consolidated financial statements for the first half of 2024 44 E/ Risk factors and related party transactions 57 F/ Outlook 58 G/ Appendix – Research and Devel |
|
| July 23, 2024 |
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) In |
|
| July 23, 2024 |
Dupixent approved in the EU as the first-ever targeted therapy for patients with COPD Exhibit 99.1 Press Release Dupixent approved in the EU as the first-ever targeted therapy for patients with COPD * First-in-world approval of Dupixent for adults with uncontrolled COPD with raised blood eosinophils based on two landmark phase 3 studies showing Dupixent significantly reduced exacerbations, improved lung function and also improved health-related quality of life * Dupixent is the fir |
|
| July 23, 2024 |
Exhibit 99.2 Press Release NEJM publishes ALTUVIIIO XTEND-Kids phase 3 data supporting its potential to transform the treatment landscape for children with severe hemophilia A • ALTUVIIIO provides high-sustained factor levels with once-weekly dosing in children under 12 with hemophilia A • XTEND-Kids results show highly effective bleed protection in hemophilia A with no inhibitor development to fa |
|
| July 2, 2024 |
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) In |
|
| July 2, 2024 |
Sanofi and Biovac spearhead polio vaccine manufacturing capabilities in Africa 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 |
|
| July 2, 2024 |
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 |
|
| July 2, 2024 |
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 |
|
| July 2, 2024 |
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 |
|
| June 28, 2024 |
United States Securities and Exchange Commission Washington, D.C. 20549 Form 11-K United States Securities and Exchange Commission Washington, D.C. 20549 Form 11-K (Mark One) x Annual Report Pursuant to Section 15(d) of the Securities Exchange Act of 1934. For the fiscal year ended December 31, 2023 OR ¨ Transition Report Pursuant to Section 15(d) of the Securities Exchange Act of 1934. (No fee required) For the transition period from to Commission File Number 1-18378 A. Full t |
|
| June 28, 2024 |
United States Securities and Exchange Commission Washington, D.C. 20549 Form 11-K United States Securities and Exchange Commission Washington, D.C. 20549 Form 11-K (Mark One) x Annual Report Pursuant to Section 15(d) of the Securities Exchange Act of 1934. For the fiscal year ended December 31, 2023 OR ¨ Transition Report Pursuant to Section 15(d) of the Securities Exchange Act of 1934. (No fee required) For the transition period from to Commission File Number 1-18378 A. Full t |
|
| June 11, 2024 |
EX-99.4 Exhibit 99.4 Press Release ASCO: Sarclisa is first anti-CD38 to significantly improve progression-free survival in combination with VRd for newly diagnosed transplant-ineligible multiple myeloma in phase 3 · Sarclisa, in combination with standard-of-care bortezomib, lenalidomide and dexamethasone (VRd) followed by Sarclisa-Rd reduced the risk of recurrence or death by 40% versus VRd follow |
|
| June 11, 2024 |
6-K 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 June 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 |
|
| June 11, 2024 |
Update on FDA priority review of Dupixent EX-99.1 Exhibit 99.1 Press Release Update on FDA priority review of Dupixent for the treatment of COPD patients with type 2 inflammation Paris and Tarrytown, NY May 31, 2024. The US Food and Drug Administration (FDA) has extended by three months the target action date of its priority review of the supplemental Biologics License Application (sBLA) for Dupixent (dupilumab) as an add-on maintenance t |
|
| June 11, 2024 |
Sanofi launches 2024 global Employee Stock Purchase Plan EX-99.3 Exhibit 99.3 Press Release Sanofi launches 2024 global Employee Stock Purchase Plan Paris, May 31, 2024. Sanofi’s global employee shareholder plan, Action 2024, opens on June 4, 2024, to around 80,000 employees in 56 countries. Now in its 10th year, the program demonstrates the ongoing commitment of Sanofi and its Board of Directors to secure that employees benefit from the company growth |
|
| June 11, 2024 |
Dupixent recommended for EU approval by the CHMP to treat patients with COPD EX-99.2 Exhibit 99.2 Press Release Dupixent recommended for EU approval by the CHMP to treat patients with COPD * Recommendation for adults with uncontrolled COPD with raised blood eosinophils based on data from two landmark Phase 3 trials demonstrating Dupixent significantly reduced exacerbations and improved lung function * If approved, Dupixent would be the first-ever targeted therapy for COPD |
|
| May 31, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No.)* Inhibrx Biosciences, Inc. (Name of Issuer) Common Stock, par value $0.0001 per share (Title of Class of Securities) 45720N103 (CUSIP Number) May 30, 2024 (Date of Event Which Requires Filing of this Statement) Check the appropriate box to designate the rul |
|
| May 30, 2024 |
Sanofi completes acquisition of Inhibrx, Inc. Exhibit 99.1 Press Release Sanofi completes acquisition of Inhibrx, Inc. Paris, May 30, 2024. Sanofi announced today the completion of its acquisition of Inhibrx, Inc. (“Inhibrx”). The acquisition adds SAR447537 (formerly INBRX-101) to Sanofi’s rare disease pipeline, underscoring the company’s commitment to pursuing differentiated and potential best-in-class medicines that build upon our existing |
|
| May 30, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the month of May 2024 Commission File Number: 001-31368 SANOFI (Translation of registrant’s name into English) 46, avenue de la Grande Armée, 75017 Paris, FRANCE (Address of principal executive offices) Ind |
|
| May 28, 2024 |
Sanofi, Formation Bio and OpenAI announce EX-99.4 Exhibit 99.4 Press Release Sanofi, Formation Bio and OpenAI announce first-in-class AI collaboration Paris, New York, N.Y., and San Francisco, CA, May 21, 2024. Sanofi, Formation Bio and OpenAI are collaborating to build AI-powered software to accelerate drug development and bring new medicines to patients more efficiently. The three teams will bring together data, software and tuned model |
|
| May 28, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM SD Specialized Disclosure Report SANOFI (Exact name of registrant as specified in its charter) Republic of France 001-31368 98-0346613 (State or other jurisdiction (Commission (IRS Employer of incorporation or organization) File Number) Identification No.) 46 avenue de la Grande Armée Paris, France 75017 (Address of princ |
|
| May 28, 2024 |
late-breaking data from NOTUS confirmatory phase 3 COPD study presented at ATS and published in NEJM EX-99.3 Exhibit 99.3 Press Release Dupixent® late-breaking data from NOTUS confirmatory phase 3 COPD study presented at ATS and published in NEJM * NOTUS results confirm landmark data from the phase 3 BOREAS study and show Dupixent significantly reduced exacerbations by 34% and improved lung function, compared to placebo, in uncontrolled chronic obstructive pulmonary disease (COPD) with evidence o |
|
| May 28, 2024 |
EX-99.5 Exhibit 99.5 Press Release Sarclisa accepted for FDA priority review for the treatment of transplant-ineligible newly diagnosed multiple myeloma • FDA Priority Review granted based on positive results from IMROZ phase 3 study • If approved, Sarclisa would be the first anti-CD38 therapy in combination with standard-of-care treatment for patients with newly diagnosed transplant-ineligible mu |
|
| May 28, 2024 |
EX-99.2 Exhibit 99.2 Press Release Sanofi adds over €1 billion for biomanufacturing to €2.5 billion already committed in major projects in France to support health sovereignty Paris, May 13, 2024. As the largest private contributor to the security and independence of France’s health ecosystem, Sanofi today announces an investment of more than €1 billion to create new bioproduction capacity at its |
|
| May 28, 2024 |
6-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the month of May 2024 Commission File Number: 001-31368 SANOFI (Translation of registrant’s name into English) 46, avenue de la Grande Armée, 75017 Paris, FRANCE (Address of principal executive offices) |
|
| May 28, 2024 |
EX-99.1 Exhibit 99.1 Press Release Sanofi and Novavax announce co-exclusive licensing agreement to co-commercialize COVID-19 vaccine and develop novel flu-COVID-19 combination vaccines • Agreement provides patients with broader access to a protein-based non-mRNA adjuvanted COVID-19 vaccine through combined commercial strength, from 2025 onwards • Accelerates potential for development of a novel fl |
|
| May 2, 2024 |
Exhibit 99.4 Press Release Beyfortus real-world evidence published in The Lancet shows 82% reduction in infant RSV hospitalizations • New real-world evidence shows Beyfortus (nirsevimab) substantially reduced RSV lower respiratory tract disease and hospitalizations in infants during the 2023-2024 RSV season, versus no intervention1-6 • Results add to the consistent high efficacy of Beyfortus again |
|
| May 2, 2024 |
frexalimab phase 2 data support potential for high sustained efficacy in multiple sclerosis Exhibit 99.1 Press Release New 48-week frexalimab phase 2 data support potential for high sustained efficacy in multiple sclerosis * Data support frexalimab as a potential first-in-class, high-efficacy, non-lymphocyte depleting treatment for relapsing multiple sclerosis * 96% of participants receiving high-dose intravenous frexalimab had no new Gd+ T1 lesions and an annualized relapse rate of 0.04 |
|
| May 2, 2024 |
Rilzabrutinib LUNA 3 phase 3 study met primary endpoint in immune thrombocytopenia Exhibit 99.2 Press Release Rilzabrutinib LUNA 3 phase 3 study met primary endpoint in immune thrombocytopenia ● Pivotal data from the first phase 3 study of a BTKi in immune thrombocytopenia (ITP) underscore the potential of rilzabrutinib to provide a clinically meaningful benefit to patients living with ITP ● Regulatory submissions in the US and EU anticipated by year-end ● Rilzabrutinib is one o |
|
| May 2, 2024 |
Annual General Meeting of April 30, 2024 Exhibit 99.3 Press Release Annual General Meeting of April 30, 2024 • Approval of the financial statements for the fiscal year 2023 • Distribution of a cash dividend of €3.76 per share, with payment as of May 15, 2024 • Board composition: renewal of two Directors and appointment of three new Independent Directors Paris, April 30, 2024. The Combined General Shareholders’ Meeting of Sanofi was held |
|
| May 2, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the month of May 2024 Commission File Number: 001-31368 SANOFI (Translation of registrant’s name into English) 46, avenue de la Grande Armée, 75017 Paris, FRANCE (Address of principal executive offices) Ind |
|
| April 25, 2024 |
Press Release Sanofi Q1: robust 7% sales growth driven by launches, underpins full-year guidance Paris, April 25, 2024 Sales growth of 6. |
|
| April 25, 2024 |
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 April 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) I |
|
| April 24, 2024 |
Division of Corporation Finance Division of Corporation Finance Office of Life Sciences 100 F Street, NE Washington, D. |
|
| April 4, 2024 |
Sanofi Debt Securities Underwriting Agreement Standard Provisions Exhibit 1.1 Sanofi Debt Securities Underwriting Agreement Standard Provisions From time to time, Sanofi, a société anonyme organized under the laws of the Republic of France (R.C.S. Paris No. 395 030 844) (the “Company”), may enter into one or more underwriting agreements substantially in the form of Annex A hereto that incorporate by reference these Standard Provisions (collectively with these St |
|
| April 4, 2024 |
EX-FILING FEES Exhibit 107 Calculation of Filing Fee Table Form F-3 (Form Type) Sanofi (Exact Name of Registrant as Specified in its Charters) Table 1—Newly Registered and Carry Forward Securities Security Type Security Class Title Fee Calculation or Carry Forward Rule (1) Amount Registered Proposed Maximum Offering Price Per Unit Maximum Aggregate Offering Price Fee Rate Amount of Registration Fe |
|
| April 4, 2024 |
Terms of the Action 2024 Shareholding Plan Exhibit 4.5 Terms of the Action 2024 Shareholding Plan The following is a summary of the terms and conditions of a “classic” employee share offering under which Sanofi, a French company listed on Euronext Paris (the Paris stock exchange) would offer shares to its group employees. Type of offering: “Classic” plan only. The offering of shares will be made pursuant to a capital increase reserved to e |
|
| April 4, 2024 |
EX-25.1 Exhibit 25.1 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM T-1 STATEMENT OF ELIGIBILITY UNDER THE TRUST INDENTURE ACT OF 1939 OF A CORPORATION DESIGNATED TO ACT AS TRUSTEE ☐ CHECK IF AN APPLICATION TO DETERMINE ELIGIBILITY OF A TRUSTEE PURSUANT TO SECTION 305(b)(2) DEUTSCHE BANK TRUST COMPANY AMERICAS (formerly BANKERS TRUST COMPANY) (Exact name of trustee as |
|
| April 4, 2024 |
As filed with the Securities and Exchange Commission on April 4, 2024 F-3ASR Table of Contents As filed with the Securities and Exchange Commission on April 4, 2024 Registration No. |
|
| April 4, 2024 |
As filed with the Securities and Exchange Commission on April 4, 2024 As filed with the Securities and Exchange Commission on April 4, 2024 Registration No. |
|
| April 4, 2024 |
Exhibit 107 Calculation of Filing Fee Tables Form S-8 (Form Type) SANOFI (Exact Name of Registrant as Specified in its Charter) Table 1: Newly Registered Securities Security Type Security Class Title Fee Calculation Rule Amount Registered Proposed Maximum Offering Price Per Unit Maximum Aggregate Offering Price Fee Rate Amount of Registration Fee Equity Ordinary Shares, par value €2. |
|
| April 4, 2024 |
SANOFI, the Company DEUTSCHE BANK TRUST COMPANY AMERICAS, as Trustee Dated as of [ ] EX-4.1 Exhibit 4.1 SANOFI, the Company and DEUTSCHE BANK TRUST COMPANY AMERICAS, as Trustee Indenture Dated as of [ ] Sanofi and Deutsche Bank Trust Company Americas Reconciliation and tie between Trust Indenture Act of 1939 and Indenture Trust Indenture Act Section Indenture Section §310(a)(1) 609 (a)(2) 609 (a)(3) 614 (a)(4) Not Applicable (a)(5) 101 and 609 (b) 608 and 610 §311(a) 613 (b) 613 § |
|
| March 20, 2024 |
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 March 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) I |
|
| March 20, 2024 |
New Phase 2b results for amlitelimab support potential for Exhibit 99.1 Press Release New Phase 2b results for amlitelimab support potential for best-in-class maintenance of response in atopic dermatitis • Late-breaking data at AAD show sustained off-drug improvements of AD signs and symptoms with amlitelimab for 28 weeks • The safety profile for patients dosed to 52 weeks was consistent with amlitelimab 24 weeks data showing it to be well-tolerated with |
|
| March 15, 2024 |
As filed with the Securities and Exchange Commission on March 15, 2024 S-8 POS As filed with the Securities and Exchange Commission on March 15, 2024 Registration No. |
|
| February 27, 2024 |
Exhibit 99.5 Press Release Phase 2 results demonstrate rilzabrutinib rapidly reduced itch severity and significantly improved disease activity in adults with chronic spontaneous urticaria • Late-breaking data at 2024 AAAAI showed rilzabrutinib, an oral BTK inhibitor, significantly reduced weekly itch severity score (ISS7) as early as the first week of treatment in adults with moderate to severe CS |
|
| February 27, 2024 |
Japan first in the world to approve Dupixent Exhibit 99.2 Press Release Japan first in the world to approve Dupixent® for chronic spontaneous urticaria (CSU) * Approval based primarily on results from Phase 3 trial showing Dupixent significantly reduced itch compared to placebo * CSU is the fifth approved indication for Dupixent in Japan and the sixth indication for Dupixent globally Paris and Tarrytown, N.Y. February 16, 2024. The Ministry |
|
| February 27, 2024 |
sBLA accepted for FDA Priority Review for treatment of COPD with type 2 inflammation Exhibit 99.4 Press Release Dupixent® sBLA accepted for FDA Priority Review for treatment of COPD with type 2 inflammation * Priority Review granted based on positive results from two Phase 3 trials * If approved, Dupixent would be the only biologic therapy for COPD and the first new treatment approach for the disease in more than a decade * Regulatory submissions are also under review in China and |
|
| February 27, 2024 |
Exhibit 99.3 Press Release Sanofi’s Board of Directors proposes the appointment of Clotilde Delbos, Anne-Françoise Nesmes and John Sundy as independent Directors Paris, February 22, 2024. At its meeting on February 22, 2024, Sanofi’s Board of Directors has decided to propose, on the occasion of its next General Shareholder Meeting to be held on April 30, 2024, the renewal of the terms of office of |
|
| February 27, 2024 |
Phase 2 data published in NEJM show potential of frexalimab as high-efficacy therapy in relapsing MS Exhibit 99.1 Press Release Phase 2 data published in NEJM show potential of frexalimab as high-efficacy therapy in relapsing MS • High-dose frexalimab significantly reduced disease activity, demonstrating 89% reduction in new brain lesions • Phase 3 trials in relapsing MS and non-relapsing secondary progressive MS currently underway Paris, February 15, 2024. The New England Journal of Medicine pub |
|
| February 27, 2024 |
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 February 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 |
|
| February 23, 2024 |
Clawback Policy This policy (the “Clawback Policy”) is adopted by Sanofi (the “Company”) as per the Nasdaq Listing Rules (the “Nasdaq Listing Rules”) as amended to include Nasdaq Listing Rule 5608 (“Listing Rule 5608") directed under Rule 10D 1 (“Rule 10D-1”) of the U. |
|
| February 23, 2024 |
Exhibit 13.1 Pursuant to section 906 of the Sarbanes-Oxley Act of 2002 (subsections (a) and (b) of section 1350, Chapter 63 of Title 18, United States Code), the undersigned officer of Sanofi, a French société anonyme (the “Company”), does hereby certify, to such officer’s knowledge, that: The annual report on Form 20-F for the year ended December 31, 2023 (the “Form 20-F”) of the Company fully co |
|
| February 23, 2024 |
Exhibit 12.2 I, Jean-Baptiste Chasseloup de Chatillon, certify that: 1. I have reviewed this annual report on Form 20-F of Sanofi; 2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to th |
|
| February 23, 2024 |
Exhibit 1.2 This text is a free translation from the French language and is supplied solely for information purposes. Only the original version in the French language has legal force. SANOFI BOARD CHARTER Approved by the Board of Directors on December 13, 2023 This text is a free translation from the French language and is supplied solely for information purposes. Only the original version in the |
|
| February 23, 2024 |
CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM Exhibit 15.1 CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM We consent to the incorporation by reference in the following Registration Statements on Form S-8 Nos. 333,270976, 333-265050, 333-256208, 333-238686 and 333-225522 and on Form F-3 No. 333-258327 of Sanofi of our reports dated February 23, 2024, with respect to the consolidated financial statements of Sanofi and its subsidiaries |
|
| February 23, 2024 |
CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM Exhibit 15.2 CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM We hereby consent to the incorporation by reference in the Registration Statements on Form S-8 (Nos. 333-270976, 333-265050, 333-256208, 333-238686 and 333-225522) and on Form F-3 (No. 333-258327) of Sanofi of our reports dated February 23, 2024 relating to the financial statements and the effectiveness of internal control over |
|
| February 23, 2024 |
EY CHANGE IN AUDITORS 16F ITEM LETTER Exhibit 15.3 EY CHANGE IN AUDITORS 16F ITEM LETTER Securities and Exchange Commission 100 F Street, N.E. Washington, DC 20549 Ladies and Gentlemen We have read Item 16F. Change in Registrant’s Certifying Accountant on page 168 of Form 20-F dated February 23, 2024 of Sanofi and are in agreement with the statements contained in paragraphs one and four. We have no basis to agree or disagree with othe |
|
| February 23, 2024 |
DESCRIPTION OF SECURITIES REGISTERED UNDER SECTION 12 OF THE EXCHANGE ACT Exhibit 2.2 DESCRIPTION OF SECURITIES REGISTERED UNDER SECTION 12 OF THE EXCHANGE ACT Introduction As of December 31, 2023, Sanofi (“Sanofi,” “we,” “us,” and “our”) had the following series of securities registered pursuant to Section 12(b) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Title of Each Class Trading Symbol Name of each exchange on which registered American |
|
| February 23, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 20-F UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 20-F (Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 Or ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 Or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXC |
|
| February 23, 2024 |
Exhibit 13.2 Pursuant to section 906 of the Sarbanes-Oxley Act of 2002 (subsections (a) and (b) of section 1350, Chapter 63 of Title 18, United States Code), the undersigned officer of Sanofi, a French société anonyme (the “Company”), does hereby certify, to such officer’s knowledge, that: The annual report on Form 20-F for the year ended December 31, 2023 (the “Form 20-F”) of the Company fully co |
|
| February 23, 2024 |
Exhibit 1.1 SANOFI Limited liability company (Société Anonyme à conseil d’administration) Registered capital : €2,529,599,938 Registered office : 46 avenue de la Grande Armée – 75017 Paris Registration number : PARIS 395 030 844 ARTICLES OF ASSOCIATION This text is a free translation from the French language and is supplied solely for information purposes. Only the original version in the French l |
|
| February 23, 2024 |
Exhibit 12.1 I, Paul Hudson, certify that: 1. I have reviewed this annual report on Form 20-F of Sanofi; 2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this r |
|
| February 15, 2024 |
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 February 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 |
|
| February 15, 2024 |
Exhibit 99.1 Press Release Peer support, flexible work arrangements, salary for a year: Sanofi launches global program for employees affected by cancer and critical illnesses Paris, February 5, 2024. Sanofi today launches ‘Cancer & Work: Acting Together’, a global program to support Sanofi employees whose lives are impacted by cancer and other critical illnesses. This program covers all Sanofi emp |
|
| February 14, 2024 |
SNY / Sanofi - Depositary Receipt (Common Stock) / Amundi - SCHEDULE 13G Passive Investment SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 SCHEDULE 13G* (Rule 13d-102) INFORMATION TO BE INCLUDED IN STATEMENTS FILED PURSUANT TO RULES 13d-1(b), (c), AND (d) AND AMENDMENTS THERETO FILED PURSUANT TO RULE 13d-2 (AMENDMENT NO. 4 )* Name of issuer: Sanofi Title of Class of Securities: Common Stock and American Depositary Receipts CUSIP Number: Not Applicable** and 80105N105 Date of E |
