Company: SNY
Filing Date: 2025-02-13
Form Type: 20-F
Source: 0001121404-25-000010
Chunk: 17

Company: Sanofi
Filing Date: 2025-02-13
Form: 20-F
Chunk 17
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 formularies, increasing the negotiating power of PBMs over drug manufacturers and thereby adversely impacting our sales .

| 6 | SANOFIFORM 20-F2024 |

| PART I                  |
| ITEM 3. Key Information |

Under the new US administration we could face unpredictable drug pricing policies, an increasing focus on price transparency, persistent supply chain challenges due to high dependency on active pharmaceutical ingredient imports, an ‘America First’ protectionist policy, and explosive growth of the federal 340B drug pricing program. In China, high pricing pressure and intensifying local competition are expected to continue as a growing number of our products are subject to national reimbursement drug list (NRDL) negotiations and national volume-based procurement (VBP) tenders, giving priority to the lowest prices with limited acceptability of value based-pricing . At market entry, new drugs listed on the NRDL had an average price cut of 60.1% over the past five years. Further expansion of the (VBP) policy to biologics and biosimilars also poses a growing threat to our key established products and our biologics portfolio , with over 500 drugs targeted for inclusion by 2025. Several factors may hinder or delay our research and development efforts to renew our portfolio of medicines and vaccines Discovering and developing a new medicine or vaccine is a costly, lengthy, and uncertain process. To be successful in the highly competitive biopharmaceutical industry, we must commit substantial resources each year to research and development in order to develop new medicines and vaccines to compensate for decreasing sales of medicines and vaccines facing patent expiration and termination of regulatory data exclusivity, introduction of lower-priced generics and biosimilars, or competition from new product launches by competitors that are perceived as being equivalent or superior to our therapies. We must pursue both research and early- and late-stage development to achieve a sustainable and well-balanced portfolio. In 2024, we spent € 7,394 million on research and development, amounting to 18.0% of our net sales. As part of an update on our Play to Win strategy , we announced in October 2023 our intent to increase our research and development spend. Failure to invest in the right technology platforms, disease areas, medicine or vaccine classes, geographic markets, and licensing or acquisition opportunities could adversely impact the productivity of our internal pipeline. We are pursuing a pipeline-driven transformation, including potential multi-indication opportunities such as amlitelimab, frexalimab, and the oral TNFR