8-KMaterial Agreements

REGENERON PHARMACEUTICALS, INC. 8-K Report, Material Agreement (Jul 31, 2015)

Filed July 31, 2015For Securities:REGN

Summary

Regeneron Pharmaceuticals, Inc. (REGN) announced a significant strategic collaboration with Sanofi Biotechnology SAS focused on the discovery, development, and commercialization of antibody-based cancer treatments in the immuno-oncology (IO) field. This agreement includes two key components: an IO Discovery Agreement and an IO License and Collaboration Agreement. The collaboration is poised to significantly advance Regeneron's pipeline in a high-growth area of oncology. The financial terms are substantial, with Regeneron receiving a total upfront payment of $625 million ($265 million under the Discovery Agreement and $375 million under the License Agreement). Furthermore, Sanofi will reimburse a significant portion of Regeneron's research and development costs, up to $825 million for the IO Discovery Program, reducing Regeneron's upfront R&D expenditure. This partnership provides Regeneron with substantial non-dilutive funding and leverages Sanofi's extensive development and commercialization capabilities, positioning both companies for potential success in the competitive immuno-oncology market.

Key Highlights

  • 1Regeneron and Sanofi entered into a global strategic collaboration to discover, develop, and commercialize antibody-based cancer treatments in immuno-oncology.
  • 2Regeneron will receive a total upfront payment of $625 million from Sanofi.
  • 3Sanofi will reimburse up to $825 million of Regeneron's costs for the IO Discovery Program, significantly de-risking early-stage research.
  • 4The collaboration includes an IO Discovery Agreement, where Regeneron will identify and validate IO targets and develop antibodies through proof of concept, with a potential 5-year term extendable by Sanofi.
  • 5The IO License and Collaboration Agreement allows Sanofi to license candidates from the discovery program, with joint development and commercialization responsibilities.
  • 6Regeneron's lead immuno-oncology candidate, targeting PD-1 (REGN2810), will be co-developed with Sanofi, with shared development costs and equal profit sharing globally.
  • 7A significant milestone payment of $375 million is available to Regeneron if sales of PD-1 targeting products and related combinations exceed $2 billion.

Frequently Asked Questions

The primary focus of the collaboration is to discover, develop, and commercialize antibody-based cancer treatments in the field of immuno-oncology (IO). This means both companies will work together on novel approaches to harnessing the immune system to fight cancer.

Regeneron receives substantial financial benefits, including a total upfront payment of $625 million. Additionally, Sanofi will reimburse Regeneron for a significant portion of the research and development costs, up to $825 million, for the discovery program. This provides substantial non-dilutive funding and reduces Regeneron's financial burden for early-stage research.

The responsibilities are shared and can alternate. For candidates licensed by Sanofi, they will co-develop and co-commercialize. Sanofi will lead commercialization outside the U.S., while the U.S. commercialization lead will alternate on a candidate-by-candidate basis. Both parties can co-promote. Development costs are generally shared, with specific arrangements for reimbursement and profit sharing.

REGN2810, Regeneron's antibody product candidate targeting PD-1, is a key asset in this collaboration. It will be co-developed with Sanofi, with shared development costs and equal profit sharing worldwide. Regeneron will lead U.S. commercialization, with Sanofi leading ex-U.S. commercialization. This indicates strong confidence in REGN2810's potential.