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.

Frequently Asked Questions

This 8-K filing announces a material definitive agreement, specifically a collaboration between Regeneron Pharmaceuticals and Teva Pharmaceuticals International GmbH for the development and commercialization of fasinumab (REGN475).

Teva will pay Regeneron $250 million upfront. They will also share equally in ongoing research and development costs. Regeneron is eligible for up to $460 million in development and regulatory milestones, and potentially up to $1.9 billion in additional contingent payments tied to net sales.

The collaboration covers the development and commercialization of fasinumab worldwide, with the exclusion of Japan, South Korea, Taiwan, Indonesia, Thailand, Philippines, Malaysia, Singapore, Vietnam, Myanmar, and Sri Lanka. Regeneron leads in the U.S., while Teva leads in the rest of the world within the defined territory.

A standstill provision is a contractual agreement where Teva and its affiliates are prohibited from attempting to influence the control of Regeneron or acquiring more than 5% of Regeneron's outstanding shares for a specified period. This is common in such collaborations to ensure a focused partnership and prevent potential hostile takeovers or undue influence.