Company: SNY
Filing Date: 2025-02-13
Form Type: 20-F
Source: 0001121404-25-000010
Chunk: 271

Company: Sanofi
Filing Date: 2025-02-13
Form: 20-F
Chunk 271
---
, which has been dormant over the past year. Genzyme Corporation does not expect further activity in this matter. In November 2023, Sanofi US received a CID from the US Department of Justice regarding an investigation into Sanofi’s pricing submissions for Admelog. On February 26, 2024, the US District Court unsealed the underlying whistleblower complaint and granted Sanofi's motion to dismiss in August 2024. Plaintiff filed a second amended complaint, which the Court dismissed with prejudice on December 10, 2024. Plaintiff did not appeal and this matter is now closed. Insulin-Related Litigation In December 2016 and January 2017, two putative class actions were filed against Sanofi US and Sanofi GmbH in the US Federal Court in Massachusetts on behalf of direct purchasers of Lantus alleging certain antitrust violations. Sanofi GmbH was later dismissed from the actions. In January 2018, the Court dismissed Plaintiffs’ consolidated amended complaint against Sanofi US. Plaintiffs appealed that order to the Court of Appeals for the First Circuit, which issued its decision on February 13, 2020, reversing and remanding to the district court. In January 2021, Sanofi-Aventis Puerto Rico, Inc. (Sanofi PR) was added as a defendant. In October 2022, plaintiffs informed Sanofi US and Sanofi PR that they would proceed via joinder rather than move for class certification. Consistent with the Court's joinder deadline, new plaintiffs moved to intervene on January 3, 2023. Fact discovery has completed, and expert discovery is underway. There are a number of insulin-related litigation matters pending in the US federal and state courts. These include cases brought on behalf of putative classes of consumers, wholesale purchasers of insulin, and state and local governments. The cases, which have been filed against Sanofi US along with other insulin manufacturers and, in some cases, pharmacy benefit managers, challenge those entities’ insulin pricing practices (including Sanofi’s pricing practices for Lantus, Apidra, Toujeo and/or Soliqua). The suits allege some combination of: violations of the Racketeer Influenced and Corrupt Organizations Act (“RICO Act”); violations of the Robinson-Patman Act; violations of various state unfair/deceptive trade practices statutes; unjust enrichment; common-law fraud; and civil conspiracy. In August 2023, the vast majority of the insulin-related litigation was consolidated in a multidistrict litigation (