Company: SNY
Filing Date: 2025-02-13
Form Type: 20-F
Source: 0001121404-25-000010
Chunk: 272

Company: Sanofi
Filing Date: 2025-02-13
Form: 20-F
Chunk 272
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MDL) in federal court in New Jersey. The MDL proceedings currently include cases brought by 14 state attorneys general (Arizona, Arkansas, California, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Mississippi, Montana, Oklahoma, Texas, and Utah) and Puerto Rico, as well as over 400 cases brought by other plaintiffs. On January 24, 2024, the District Court for the District of New Jersey (which is presiding over the MDL) issued a decision denying plaintiffs’ motion for class certification in a putative class action on behalf of consumers. Following denial of plaintiffs’ appeal of that decision, plaintiffs filed an amended complaint, which defendants have moved to strike or dismiss. On December 31, 2024, the District Court dismissed some of plaintiffs’ claims but allowed others to

| SANOFIFORM 20-F2024 | 163 |

| PART I                        |
| ITEM 8. Financial Information |

proceed. Sanofi has also settled (on non-monetary terms) a case brought by Minnesota’s Attorney General and has secured the voluntary dismissal of another case brought by a group of entities known as Medicare Secondary Payer (MSP) Recoveries. Mylan vs Sanofi antitrust complaint In May 2023, Mylan Pharmaceuticals Inc., Mylan Specialty LP and Mylan Inc. (Mylan) filed suit against Sanofi-Aventis US LLC, Sanofi SA, Aventis Pharma SA and Sanofi-Aventis Puerto Rico (Sanofi) in the Western District of Pennsylvania for alleged antitrust violations related to Mylan’s insulin product Semglee. Sanofi has moved to dismiss the complaint. B. Significant Changes Updates to Note D.22. N/A Other Changes On January 21, 2025, Opella 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 of the AUT and makes Cialis the first PDE-5 inhibitor to achieve this milestone. During the meeting of the Board of Directors on January 29, 2025, the Board authorized Sanofi to repurchase the Company's shares, for an amount not exceeding €5 billion, under the terms and conditions set by the General Meeting of April 30, 2024 in its 19th resolution. As part of this authorization, Sanofi entered into a share buyback