Company: SNY
Filing Date: 2025-02-13
Form Type: 20-F
Source: 0001121404-25-000010
Chunk: 11

Company: Sanofi
Filing Date: 2025-02-13
Form: 20-F
Chunk 11
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 sales, business, and results of operations. In addition, all aspects of our business, including research and development, manufacturing, marketing, reimbursement, pricing, and sales, are subject to extensive legislation and governmental regulation. Changes in applicable laws and the costs of compliance with such laws and regulations could have an adverse effect on our business. For example, the pharmaceutical industry has experienced challenges due to the implementation of the new European Union regulations for Medical Devices (EU MDR) and for In-Vitro Diagnostic Devices (IVDR), which entered into force in May 2021 and May 2022, respectively. In October 2024, the European Parliament adopted a resolution for a revision of these regulations with a view to addressing challenges, in particular obstacles associated with the implementation of the EU MDR and IVDR; however, the outcome of that resolution is uncertain at this stage. The FDA's recent rulemaking on laboratory-developed tests (LDTs), implemented in May 2024, introduces significant regulatory uncertainty and potential delays in product availability as clinical testing laboratories in the US adapt to new requirements; this poses a risk to Sanofi clinical study timelines and the availability of testing to support commercial products given that LDTs are used for patient selection, product dose decisions, treatment monitoring and clinical study endpoints. For information about risks related to changes (i) in proprietary rights rules and regulations, see “– We rely on our patents and other proprietary rights to provide exclusive rights to market certain of our products. If such patents and other rights were limited, invalidated, or circumvented, our financial results could be adversely affected” below; and (ii) in environmental rules and regulations, see “– Management of the historical contamination related to our past industrial activities could adversely impact our results of operations and reputation” below. In addition, changes in tax laws or regulations or their interpretation or exposures to additional tax liabilities around the world could negatively impact our operating results. Changes to tax laws or regulations may occur at any time, and any related expense or benefit recorded may be material to the fiscal quarter and year in which the law change is enacted. As a result of the 2024 presidential and legislative elections in the United States, changes to applicable laws and regulations that have been announced, proposed, and/or adopted, or could be made or expanded in the future, may result in new or expanded trade restrictions by the United States and/or other countries, including, but not limited to, tariffs or import taxes being applied to imported goods and services which could affect our operations and