Company: SNY
Filing Date: 2025-02-13
Form Type: 20-F
Source: 0001121404-25-000010
Chunk: 16

Company: Sanofi
Filing Date: 2025-02-13
Form: 20-F
Chunk 16
---
 US insurers and pharmacy benefits managers (PBMs), and – discriminatory and non-transparent pricing and procurement policies (e.g. government procurement restrictions, import bans) in favor of domestic pharmaceutical companies, – widespread use of health technology assessment (HTA) to inform coverage and reimbursement decisions, and – more stringent evidence and value requirements (e.g. comparative effectiveness, patient preferences, real-word evidence, health economic modelling) by payers and HTA authorities, raising the bar for market entry, • u nreasonable thresholds for cost-effectiveness : – increasingly restrictive HTA decisions with significant variation across markets; increased generic and biosimilar competition, accelerating price erosion, and – next generation biosimilars coming to the market across major therapeutic areas; and • potential savings from increased biosimilar use, which are expected to be a cumulative $290 billion globally from 2023 to 2027 and could reach $383 billion according to the IQVIA Institute's recent Global Use of Medicines report: – evolving regulatory landscapes to support interchangeability (e.g., in the US and EU) and pharmacy substitution (e.g. in the EU Nordic countries, Germany and France). In the United States, which accounted for 48.7% of our net sales in 2024, the Inflation Reduction Act (IRA) was enacted in August 2022. The law includes three core drug pricing provisions (Medicare negotiation, Part D redesign, and Medicare inflation penalties). Significant uncertainties remain on the process and methods of Medicare negotiation. While no Sanofi product was among the first ten drugs to face Medicare price negotiations in 2024, the new legislation may likely have a negative impact on our revenue growth and will influence our portfolio strategy in the mid- to longer term. However, recent election results in the US may spark uncertainty for the IRA. Although a full repeal of the IRA may be unlikely due to budgetary impact, the new US administration could change some of the IRA provisions, including Medicare drug price negotiations. Furthermore, we face increasing pricing pressure and gross-to-net (GTN) erosion from continuing vertical integration and consolidation of the US health insurance market, as well as political scrutiny over insulin prices, which resulted in the list price of Lantus being lowered by 78% effective January 1, 2024. With the three largest pharmacy benefit manager group purchasing organizations (PBM GPOs) (Ascent, Zinc and Emisar) now covering over 85% of prescription drug claims, consolidation has led to increased utilization management and restrictive