Company: SNY
Filing Date: 2025-02-13
Form Type: 20-F
Source: 0001121404-25-000010
Chunk: 317

Company: Sanofi
Filing Date: 2025-02-13
Form: 20-F
Chunk 317
---
 price, the terms of the specific rebateprograms, and the historical trend of actual rebate claims paid. The independent estimate was compared to the provisionsrecorded by the Company. Additionally, these procedures included testing actual rebate claims paid and evaluating thecontractual terms of the Company’s rebate agreements.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  |

| SANOFIFORM 20-F2024 | 189 |

| 2024CONSOLIDATED FINANCIAL STATEMENTS                    |
| Report of Independent Registered Public Accounting Firms |

Provisions for product liability risks, litigation and other and contingent liabilities

| Descriptionof the Matter               | Provisions for product liability risks, litigation and other were recorded in an amount of €1,676 million at December 31, 2024. Asdescribed in Notes B.12., D.19.3. and D.22. to the consolidated financial statements, the Company records such provisions when anoutflow of resources is probable and the amount of the outflow can be reliably estimated. The Company also discloses thecontingent liabilities in circumstances where management is unable to make a reasonable estimate of the expected financial effectthat will result from ultimate resolution of the proceeding, or a cash outflow is not probable.The pharmaceutical industry is highly regulated, which increases the inherent risk of litigation and arbitration. The Company isinvolved in litigation, arbitration and other legal proceedings. These proceedings are typically related to litigation concerningproduct liability claims, intellectual property rights, competition law and trade practices, as well as claims under warranties orindemnification arrangements relating to business divestments. The issues raised by these claims are highly complex and subjectto substantial uncertainties; therefore, the probability of loss and an estimation of damages are difficult to ascertain.The principal considerations for our determination that auditing the provision for product liability risks, litigation and other, andauditing the contingent liabilities is especially challenging, subjective and required complex auditor judgment resulted from thedetermination that the measurement of the provisions can involve a series of complex judgments about future events and can relyheavily on estimates and assumptions by management. There is inherent uncertainty related to these cases and in estimating thelikelihood and outcome of the cases. |
| How We Addressedthe Matter inOur Audit | Addressing the matter involved performing procedures and evaluating audit evidence in connection with forming our overallopinion on the consolidated financial statements. These audit procedures included obtaining an understanding of the process andassessing the design and testing the operating effectiveness of controls relating to management’s evaluation of the provisions forproduct liability risks, litigation