Company: SNY
Filing Date: 2025-02-13
Form Type: 20-F
Source: 0001121404-25-000010
Chunk: 18

Company: Sanofi
Filing Date: 2025-02-13
Form: 20-F
Chunk 18
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1si, intended to address unmet medical needs in markets with a low penetration of novel therapies, or where there is no current effective therapy approved. We focus our R&D strategy on therapeutics in immunology, rare diseases, neurology, and selectively in oncology. In 2021, Sanofi acquired Translate Bio to accelerate the deployment of mRNA technology for the development of new vaccines, including for seasonal influenza, and beyond vaccines, therapeutics where there is a strong unmet medical need. However, mRNA technology is still in its early days and the ability of this technology to produce strong results with an acceptable safety profile remains to be fully asserted. We may fail to improve our development productivity sufficiently to sustain our pipeline (see also “— We may fail to successfully identify external business opportunities or realize the anticipated benefits from our strategic investments or divestments” below). The competitive landscape includes a high level of uncertainty as numerous companies are working on or may be evaluating similar targets to us. A medicine or vaccine considered as promising at the beginning of its development may become less attractive if a competitor addressing the same unmet need reaches the market earlier. There can be no assurance that any of our pipeline candidates will be proven safe or effective (see “Item 4. Information on the Company — B. Business Overview — B.4. Global research & development”). Over these research and development cycles, usually spanning several years, there is a substantial risk at each stage of development – including pre-clinical activities and clinical studies – that we will not achieve our goals of safety and/or efficacy and that we will have to abandon a medicine or vaccine in which we have invested substantial amounts of money and human resources. For instance, the global clinical development program of amcenestrant for breast cancer was discontinued in August 2022 following the outcome of the prespecified interim analysis of a Phase 3 study. As another example, in late 2023, based on the outcome of a prespecified interim analysis of a Phase 3 study, the global clinical development program for tusamitamab ravtansine was discontinued after the Independent Data Monitoring Committee found that the compound, as a monotherapy, did not meet its dual primary endpoints. Studies are increasingly designed with clinical endpoints of superiority, which means that failure to achieve those endpoints could damage the medicine or vaccine’s outlook and our overall development program. Decisions concerning the studies to be carried out can have a significant impact on the marketing strategy for a given medicine or vaccine. Multiple in-depth studies can demonstrate that