Company: SNY
Filing Date: 2025-02-13
Form Type: 20-F
Source: 0001121404-25-000010
Chunk: 19

Company: Sanofi
Filing Date: 2025-02-13
Form: 20-F
Chunk 19
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 a medicine or vaccine has additional benefits, facilitating the marketing, but such studies are expensive and time consuming and may delay the medicine or vaccine’s submission to regulatory authorities for approval. In addition, following (or in some cases in parallel with) the marketing authorization, a dossier is also submitted to governmental agencies and/or national or regional third-party payers for review. These Health Technology Assessment (HTA) bodies evaluate evidence on the value of the new medicine or vaccine, assess the medical need it serves, and provide recommendations on the corresponding reimbursement. Such analyses may require additional studies, including comparative studies, which may effectively delay marketing, change the population which the new medicine or vaccine treats, and add costs to the development. Our continuous investments in our research and development pipeline, and in launches of newly registered molecules, could therefore result in increased costs without a proportionate increase in revenues, which would negatively affect our operating results and profitability. Furthermore, there can be no assurance that all medicines or vaccines approved or launched will generally achieve commercial success. Finally, even after a medicine or vaccine reaches the market, certain developments following regulatory approval may reduce demand for them. Clinical studies and post-marketing surveillance of certain marketed medicines and vaccines have the potential to raise concerns among some prescribers and patients relating to the safety, efficacy, or tolerability of pharmaceuticals in general, which could negatively affect sales or lead to increased volatility in market reaction.

| SANOFIFORM 20-F2024 | 7 |

| PART I                  |
| ITEM 3. Key Information |

Breaches of data security, disruptions of information technology systems and cyber threats could result in financial, legal, competitive, operational, business, or reputational harm Our business depends heavily on the use of interdependent information technology systems, including Internet-based systems and digital tools. Certain key areas such as research and development, production and sales are largely dependent on our information systems (including cloud-based computing) or those of third-party providers (including for the storage and transfer of critical, confidential, sensitive, or personal information regarding our patients, clinical studies, vendors, customers, employees, collaborators and others). We are therefore vulnerable to cybersecurity attacks and incidents and misuse or manipulation of any of these IT systems could result in exposure of confidential information or the modification of critical data. We and our third-party service providers, suppliers, contract manufacturers, distributors or other contracting third parties use, to the best of our ability, secure information technology systems for the protection of data and threat detection. Like many companies, we may experience certain of