Company: SNY
Filing Date: 2025-02-13
Form Type: 20-F
Source: 0001121404-25-000010
Chunk: 270

Company: Sanofi
Filing Date: 2025-02-13
Form: 20-F
Chunk 270
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 and could affect our business and reputation. While we do not currently believe that any of these legal proceedings will have a material adverse effect on our financial position, litigation is inherently unpredictable. As a consequence, we may in the future incur judgments or enter into settlements of claims that could have a material adverse effect on results of operations, cash flows and/or our reputation. Government Investigations and Related Litigation From time to time, subsidiaries of Sanofi are subject to governmental investigations and information requests from regulatory authorities inquiring as to the practices of Sanofi with respect to the sales, marketing, and promotion of its products. From 2017 through 2024, several federal and state government agencies issued Civil Investigative Demands (CIDs) or other discovery requests calling for the production of documents and information relating to Sanofi’s trade and pricing practices for its insulin products and/or Lantus-related litigation. Several of those investigations have concluded: Sanofi US reached a resolution with the New York Attorney General in April 2023; the Ohio Attorney General closed its investigation in November 2023; and although the Federal Trade Commission (FTC) has not formally closed its investigation, it filed a lawsuit against Pharmacy Benefit Managers (PBMs) only in September 2024, and Sanofi does not expect the FTC to commence litigation against the manufacturers at this time. Although several other investigations (including by the State Attorney General’s offices in California, Colorado, Texas, Vermont and Washington), have not been closed, those investigations have been dormant for several years and Sanofi US does not anticipate undertaking further action on them at this time. In September 2019, Sanofi US received a CID from the US Department of Justice concerning Dupixent, Kevzara, Praluent and Zaltrap. In June 2021, the government declined to intervene in the underlying complaint which was filed in November 2018. The government investigation into this matter is now closed. Relators, however, filed their First Amended Complaint in October 2021, which the Court dismissed with prejudice in August 2023. Relators have since filed an appeal to the Ninth Circuit Court of Appeals in this non intervened False Claims Act matter against Sanofi and co-promotion partner Regeneron. In February 2020, Genzyme Corporation received a CID from the US Department of Justice. The CID requests documents and information relating to Genzyme Corporation’s payments made to vendors or developers of electronic health record technology. Genzyme Corporation has cooperated with this investigation