8-KMaterial Agreements

REGENERON PHARMACEUTICALS, INC. 8-K Report, Material Agreement (Sep 20, 2016)

Filed September 20, 2016For Securities:REGN

Summary

Regeneron Pharmaceuticals, Inc. has entered into a significant collaboration agreement with Teva Pharmaceuticals International GmbH, a subsidiary of Teva Pharmaceutical Industries Ltd., for the development and commercialization of its investigational nerve-growth-factor antibody, fasinumab (REGN475). This agreement, effective September 17, 2016, marks a key strategic move for Regeneron as fasinumab is currently in Phase 3 trials for osteoarthritis pain and Phase 2 for chronic low-back pain. The collaboration involves an upfront payment of $250 million from Teva to Regeneron, with shared responsibility for ongoing R&D costs. Regeneron will lead development and commercialization in the United States, while Teva will manage these activities outside the U.S. The agreement also outlines potential milestone payments of up to $460 million and significant contingent payments of up to $1.9 billion based on specified net sales targets, highlighting the substantial commercial potential Regeneron sees in fasinumab. Regeneron will also be responsible for product manufacturing and supply.

Key Highlights

  • 1Regeneron enters into a global collaboration with Teva Pharmaceuticals for fasinumab (REGN475), an investigational nerve-growth-factor antibody.
  • 2Fasinumab is in Phase 3 development for osteoarthritis pain and Phase 2 for chronic low-back pain.
  • 3Teva will pay Regeneron $250 million upfront.
  • 4Both companies will share equally in ongoing research and development costs.
  • 5Regeneron will lead U.S. development and commercialization; Teva will lead outside the U.S.
  • 6Regeneron is eligible to receive up to $460 million in development/regulatory milestones and up to $1.9 billion in contingent payments based on sales.
  • 7Teva has agreed to a standstill provision, limiting its ability to influence Regeneron's control or acquire significant shares for a defined period.

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