8-KMaterial Agreements

REGENERON PHARMACEUTICALS, INC. 8-K Report, Material Agreement (Aug 19, 2020)

Filed August 19, 2020For Securities:REGN

Summary

Regeneron Pharmaceuticals, Inc. has entered into a significant global strategic collaboration with F. Hoffman-La Roche Ltd and Genentech, Inc. (collectively, Roche) to develop, manufacture, and commercialize its investigational two-antibody cocktail treatment (REGN-COV2) for SARS-CoV-2. This agreement, effective August 18, 2020, outlines a framework for joint development and commercialization efforts worldwide. Under the terms, Regeneron and Roche will share responsibilities for development and regulatory approvals, with Regeneron retaining exclusive rights in the United States and Roche in the "Roche Territory" (outside the US). The collaboration includes significant manufacturing commitments from both parties, aiming to produce substantial quantities of the antibody treatment. Financial terms indicate a profit-sharing arrangement where Regeneron is expected to receive approximately 50%-60% of worldwide gross profits after commercialization begins, with each party bearing its own commercial expenses within its designated territory.

Key Highlights

  • 1Regeneron partners with Roche and Genentech for global development, manufacturing, and commercialization of its investigational COVID-19 antibody cocktail (REGN-COV2).
  • 2The collaboration grants Regeneron exclusive rights for marketing and distribution in the United States.
  • 3Roche receives exclusive rights for marketing and distribution in territories outside the United States (the "Roche Territory").
  • 4Both parties commit substantial manufacturing capacity, with Regeneron obligated to provide at least 40,000 liters and Roche at least 100,000 liters of annualized bioreactor capacity.
  • 5Regeneron is projected to receive approximately 50%-60% of worldwide gross profits from the Antibody Product, depending on manufacturing contributions.
  • 6Joint funding is required for ongoing Phase 3 prevention and Phase 1 safety studies for COVID-19, as well as any future global studies.
  • 7The agreement has specific termination clauses, including those related to regulatory milestones (e.g., FDA Emergency Use Authorization by May 31, 2021) and the emergence of superior third-party treatments.

Frequently Asked Questions

The primary purpose is to accelerate the development, manufacturing, and global commercialization of Regeneron's investigational two-antibody cocktail treatment (REGN-COV2) designed to prevent and treat SARS-CoV-2 infections.

Worldwide gross profits will be aggregated and shared based on a pre-specified formula. Regeneron is estimated to receive approximately 50%-60% of these profits, with the exact percentage dependent on the volume of manufactured Antibody Product contributed by each party. This profit sharing begins after regulatory approval and market supply.

Regeneron retains exclusive rights to obtain regulatory approval, market, distribute, sell, and offer for sale the Antibody Product in the United States. Roche (Roche Basel and Genentech) holds co-exclusive rights for regulatory approval worldwide outside the U.S. and exclusive rights for marketing, distribution, sale, and offering for sale in this "Roche Territory."

Yes, the agreement includes several termination conditions. Roche can terminate under specific circumstances, such as clinical holds on key studies lasting beyond a certain period, failure to receive FDA Emergency Use Authorization by May 31, 2021, failure to file for full U.S. regulatory approval by May 31, 2021, or if Regeneron ceases development. Additionally, Roche may terminate if a third-party antibody product demonstrates a substantially superior public health benefit.