Risk Factors Update Summary

• Increased risks related to operating in foreign countries, particularly in certain markets.
• Risks associated with AI solutions leading to unauthorized access to personal data and reputational harm.
• Addition of EYLEA HD to the ophthalmology portfolio, with a 6% decrease in aggregate EYLEA HD and EYLEA net product sales in the U.S. in 2023 compared to 2022.
• Expanded commercial capabilities outside the US, particularly in EU countries and Japan.
• Potential impact of state consumer privacy laws on marketing activities based on health conditions.
• Increased dependence on EYLEA HD, with a concentration of 45% of total revenues from EYLEA HD and EYLEA net product sales in the U.S. in 2023.
• Significantly expanding the scope of activities in existing and additional countries.
• Increased enforcement activities in the EU regarding personal data transfer and GDPR compliance.
• Potential impact of EYLEA HD commercialization on revenue, profitability, and financial condition, with uncertainties regarding regulatory approvals and market exclusivity.
• Enhanced compliance requirements with data privacy laws, including GDPR and evolving regulations.
• Risks related to commercialization of EYLEA HD and EYLEA, including competition from VEGF inhibitors and biosimilar versions, and potential safety concerns.
• Expansion of commercial capabilities outside the U.S. for products like Libtayo and Dupixent, with a need to establish sales, marketing, and distribution capabilities.
• Impact of regulatory approval delays on commercialization efforts, with delays in FDA approval for EYLEA HD due to unresolved observations at a third-party provider.
• Risks associated with manufacturing and supply chain disruptions, including delays in FDA approval due to unresolved observations at a contract manufacturing organization.