8-KMaterial Agreements

REGENERON PHARMACEUTICALS, INC. 8-K Report, Material Agreement (Jan 16, 2014)

Filed January 16, 2014For Securities:REGN

Summary

Regeneron Pharmaceuticals, Inc. has entered into a material definitive agreement with Bayer HealthCare LLC, focusing on the joint development and commercialization of a novel antibody product candidate targeting Platelet Derived Growth Factor Receptor Beta (PDGFR-b). This collaboration, initially led by Regeneron through proof-of-concept studies, offers Bayer HealthCare an opt-in right for further joint development and exclusive commercialization outside the United States. The agreement involves an upfront payment of $25.5 million from Bayer HealthCare to Regeneron, along with cost-sharing arrangements for development and potential milestone payments. Notably, Regeneron retains exclusive commercialization rights and all profits within the United States, while profits outside the U.S. would be shared equally if Bayer HealthCare opts in. The deal also includes a "standstill" provision limiting Bayer HealthCare's influence on Regeneron's corporate control.

Key Highlights

  • 1Regeneron enters into a strategic collaboration with Bayer HealthCare for a PDGFR-b antibody product candidate.
  • 2The collaboration focuses on ocular diseases, including potential combinations with EYLEA®.
  • 3Bayer HealthCare makes an upfront payment of $25.5 million to Regeneron.
  • 4Regeneron will conduct initial development through proof-of-concept, with Bayer HealthCare having an opt-in right.
  • 5Bayer HealthCare gains exclusive commercialization rights outside the U.S. upon opting in, with profit sharing.
  • 6Regeneron retains exclusive commercialization rights and all profits within the U.S.
  • 7A "standstill" agreement is in place, limiting Bayer HealthCare's ability to influence Regeneron's control or acquire significant shares.

Frequently Asked Questions

The agreement's primary purpose is the joint development and commercialization of a novel antibody product candidate targeting Platelet Derived Growth Factor Receptor Beta (PDGFR-b), with a focus on treating ocular diseases, potentially in combination with Regeneron's EYLEA®.

Regeneron receives an upfront payment of $25.5 million from Bayer HealthCare. There are also provisions for cost-sharing in development, potential milestone payments if Bayer HealthCare opts in, and a 50% profit share on sales outside the United States if the collaboration proceeds fully.

Regeneron will conduct the initial development through the first proof-of-concept study. Crucially, Regeneron retains exclusive commercialization rights and all profits within the United States. Regeneron also has the right to opt out of the collaboration after the proof-of-concept study.

Bayer HealthCare has the option to opt into a broader collaboration after Regeneron completes the initial proof-of-concept. If they opt in, they will gain exclusive commercialization rights outside the United States, share in development costs, and receive 50% of the profits from ex-U.S. sales. They are also obligated to make an upfront payment and potential development milestone payments.