FDA Approves Sanofi's New Factor VIII Therapy for Hemophilia A

The U.S. Food and Drug Administration (FDA) has approved Sanofi's ALTUVIIIO™, a new class of factor VIII therapy designed for once-weekly administration in patients with hemophilia A. The therapy aims to provide significant protection against bleeds.

The approval, granted on February 22, 2023, led to a reversal of previously recorded impairment losses totaling €2,154 million against intangible assets associated with the Eloctate franchise. These assets had been partially written down in 2019. Sanofi reported that the net effect after tax was a gain of €1,651 million, and this adjustment does not impact cash flows.

Following this adjustment, Sanofi's reported IFRS net income for the year ended December 31, 2022, is €8,371 million, an increase from the previously reported €6,720 million. Earnings per share (IFRS EPS) for 2022 was revised to €6.69 from €5.37. Total equity now stands at €75,152 million.

Sanofi also announced the filing of its 2022 Form 20-F with the U.S. Securities and Exchange Commission (SEC) and its "Document d’Enregistrement Universel" with the French market regulator. The company confirmed that its business net income (a non-IFRS measure) for 2022 remains unchanged, as does the proposed dividend.