Company: SNY
Filing Date: 2025-02-13
Form Type: 20-F
Source: 0001121404-25-000010
Chunk: 31

Company: Sanofi
Filing Date: 2025-02-13
Form: 20-F
Chunk 31
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. It may also take a considerable amount of time and be difficult to implement a risk analysis and risk mitigation plan after the acquisition of an activity or business is completed due to lack of historical data. Acquired businesses may not always be in full compliance with legal, regulatory or Sanofi standards, including, for example, current Good Manufacturing Practices (cGMP), which can be costly and time consuming to remedy. As a result, risk management and coverage of such risks, particularly through insurance policies, may prove to be insufficient or ill-adapted.

| 12 | SANOFIFORM 20-F2024 |

| PART I                  |
| ITEM 3. Key Information |

With respect to divestments, their financial benefit could be impacted if we face significant financial claims or significant post- closing price adjustments. Furthermore, the value of the assets to be divested may deteriorate while we are in the process of executing our divestment strategy, with the risk that we do not realize the anticipated benefits. Because of the active competition among pharmaceutical groups for business development opportunities, there can be no assurance of our success in completing these transactions when such opportunities are identified. Completion of the separation of Opella is subject to conditions that may not be satisfied and we may fail to realize any or all of the anticipated benefits of the separation and/or face unintended adverse impacts on our business In October 2024, we announced that we had entered into exclusive negotiations with CD&R for the potential sale and purchase of a 50% controlling stake in Opella and that we would remain a significant shareholder in Opella. This intended separation aims at paving the way for Opella to become a new, standalone leader in Consumer Healthcare, while supporting our strategy and increased focus on innovative medicines and vaccines. This intended separation may not be completed on the expected terms or may be delayed or may not be completed at all. In particular, completion of the separation will be subject to obtaining regulatory approvals from the competent authorities. There can be no assurance that any or all of these conditions will be satisfied. There can also be no assurance regarding the ultimate timing of the planned separation. Unanticipated developments could delay, prevent or otherwise adversely affect the planned separation, including disruptions in general or financial market conditions, the political and geopolitical situations, and potential problems or delays in obtaining various regulatory approvals or clearances. Failure to complete the separation would result in the potential benefits of the separation not being realized and could have a material adverse effect on the success of Sanofi as a whole , including our results of operations