Regeneron Pharmaceuticals, Inc.: amends antibody collaboration with Sanofi

What happened

• Regeneron Pharmaceuticals, Inc. reported that on Oct 1, 2026 it entered into the Sixth Amendment to the Amended and Restated License and Collaboration Agreement with Sanofi Biotechnology SAS and Sanofi. The Sixth Amendment "announced" co-development and co-commercialization of 4 new long-acting, Regeneron-invented antibodies and an upfront payment of $1.0 billion from Sanofi.

Key details

• The parties agreed to co-develop and co-commercialize 4 new antibodies: an IL-13 antibody, an IL-4 antibody, an IL-4Rα antibody, and an IL-4xIL-13 bispecific antibody; Regeneron has an option by asset to include Sanofi’s Phase 2/3 asset lunsekimig and another Sanofi early development product (Regeneron would reimburse certain development costs if it exercises an option).
• Sanofi will pay $1.0 billion upfront and Regeneron may receive up to an additional $7.0 billion upon achievement of certain development, regulatory, and commercial milestones. Global profits on New Licensed Products will be shared equally (50/50) as calculated under the Antibody LCA.
• Development costs for licensed products under the Antibody LCA, including the New Licensed Products, will be shared equally; development costs above a budget cap for the New Licensed Products will be Regeneron’s responsibility, subject to certain recoupment rights. Regeneron will be lead development party and lead regulatory party prior to filing for marketing approval; Regeneron will remain lead regulatory party for the United States and Sanofi will be lead regulatory party and lead commercialization party outside the United States.
• Regeneron currently expects an acquired in-process research and development (IPR&D) charge of approximately $22 million pre-tax for third quarter 2026, which is expected to reduce GAAP and non-GAAP net income per diluted share for the quarter by approximately $0.18.

Why it may matter

• Item 1.01 (entry into a material definitive agreement) reports the Sixth Amendment to the Antibody LCA with Sanofi and the terms summarized above. Item 2.02 (results of operations and financial condition) reports the expected acquired IPR&D charge of approximately $22 million pre-tax and the expected $0.18 per diluted share impact for third quarter 2026. Item 8.01 (other events) reports that Regeneron and Sanofi entered into a settlement agreement in connection with the Sixth Amendment that resulted in dismissal of Regeneron’s lawsuit concerning access to commercialization information and audit rights under the Antibody LCA. The filing does not show why the company acted.