Company: SNY
Filing Date: 2025-02-13
Form Type: 20-F
Source: 0001121404-25-000010
Chunk: 15

Company: Sanofi
Filing Date: 2025-02-13
Form: 20-F
Chunk 15
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 the operation of our business requires data to flow freely across borders of numerous countries. The legal and regulatory environment of data privacy is diversified, with regional legislation such as the General Data Protection Regulation (GDPR) in Europe, the Personal Information Protection Law (PIPL) in China, and other significant privacy legislation, including the California Consumer Privacy Act (CCPA) in the United States. As the framework continues to evolve, some uncertainty remains with respect to absence of clear guidance or case law. Such uncertainty could result in an operational risk limiting or preventing the transfer of data across borders, which may have an impact on our activities (e.g., on clinical studies). Breach of the regulations described above could also carry financial sanctions and may harm our reputation and those of our activities that rely on personal data processing. Furthermore, the increasing volume of data processed and advances in new technologies, such as artificial intelligence, have resulted in a greater focus on data governance and the ethical use of personal data. Failure in our data governance and ethical use of personal data could affect our business and reputation. Risks relating to our business The pricing and reimbursement of our products is negatively affected by increasing cost containment pressures and decisions of governmental authorities and other third parties The commercial success of our existing products and our product candidates depends in part on their pricing and reimbursement conditions. Our products are negatively affected by continued downward pricing pressure and scrutiny due, inter alia, to: • stricter price and access controls imposed by governments and other payers around the world: – requirements for greater transparency around drug pricing and drug development costs, – widespread use of international reference pricing and therapeutic reference pricing, among other pricing methodologies and caps, – mandatory price cuts, renegotiations, industry payback and rebates, – delisting from reimbursement and restrictions on the label population, – access restrictions for high-priced innovative medicines, – prescribing guidelines and binding medicine utilization controls, – Medicare drug price negotiations under the US Inflation Reduction Act (IRA), – greater use of tendering and centralized procurement (national/regional/class-wide level), – cross-country cooperation in price negotiations, contracting or procurement, which is already occurring to some extent, such as the Vaccine Alliance (GAVI), the BeNeLuxA alliance in Europe, and the Pan American Health Organization (PAHO), – shifting of the payment burden to US patients and access disruptions through copay accumulator and maximizer programs as well as alternative funding programs, – more aggressive formulary utilization management controls (including stepped therapy, strict prior authorization criteria, formulary exclusions) by