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

Company: Sanofi
Filing Date: 2025-02-13
Form: 20-F
Chunk 25
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/ Alliance Arrangements with Regeneron Pharmaceuticals Inc.”). We rely upon Regeneron to successfully carry out their responsibilities regarding the manufacture and supply of these collaboration antibodies (see “Item 4. Information on the Company — B. Business Overview”). In May 2024, we announced a co-exclusive licensing agreement to develop novel flu-COVID-19 combination vaccines with Novavax (see above —“Several factors may hinder or delay our research and development efforts to renew our portfolio of medicines and vaccines”). We may also rely on partners to design and manufacture medical devices, in particular for the administration of our products. Finally, we may rely on partners for the development and commercialization of in-vitro diagnostic tests used in clinical studies, and in-vitro diagnostic tests specified in the labeling of our products as necessary or useful for the management of patients taking our products. As regards some products launched or under development for which we have a collaboration agreement with partners, the terms of the applicable alliance agreement may require us to share profits and losses arising from commercialization of such products with our partners. This differs from the treatment of revenue and costs generated by other products for which we have no alliance agreement, and such profit sharing may deliver a lower contribution to our financial results. We could also be subject to the risk that we may not properly manage the decision-making process with our partners. Decisions may be controlled by, or subject to the approval of our collaboration partners, who may have views that differ from ours. We are also subject to the risk that our partners may not perform effectively, which could have a detrimental effect when our collaboration partners are responsible for the performance of certain key tasks or functions, for example related to manufacturing or distribution. This risk is further increased by the growing number of distribution centers divested by Sanofi as part of its global strategy and by the resulting growing externalization of distribution tasks and functions. Any failures in the development process or differing priorities may adversely affect our business, including the activities conducted through our collaboration arrangements. We also cannot guarantee that third-party manufacturers will be able to meet our near-term or long-term manufacturing requirements, for internal reasons (e.g. in case of financial difficulties), reasons directly related to their contractual relationship with Sanofi, or external reasons (e.g. in the event of a health crisis). Thereby, following the completion of the spin-off of EUROAPI in May 2022, EUROAPI became a third-party manufacturer and continues to manufacture a certain number of active pharmaceutical ingredients for Sanofi. We