8-KMaterial AgreementsSecurities & ListingRegulation FD+1

ALNYLAM PHARMACEUTICALS, INC. 8-K Report, Material Agreement (Apr 9, 2019)

Filed April 9, 2019For Securities:ALNY

Summary

Alnylam Pharmaceuticals, Inc. (ALNY) announced a significant strategic collaboration with Regeneron Pharmaceuticals, Inc. on April 9, 2019. This partnership aims to discover, develop, and commercialize RNA interference (RNAi) therapeutics for a broad range of diseases, focusing on targets in the eye and central nervous system (CNS), with an option to include certain liver targets. The collaboration involves substantial financial commitment from Regeneron, including a $400 million upfront payment and a $400 million equity investment at $90.00 per share, which is expected to result in Regeneron owning approximately 4.0% of Alnylam's outstanding shares. In addition to the Regeneron deal, Alnylam also announced an amendment to its existing collaboration with Genzyme Corporation concerning the ALN-AT3 program (fitusiran). This amendment concludes the research and option phase, with Alnylam transitioning a selected investigational asset to Genzyme for all future development and commercialization at Genzyme's cost, in exchange for potential tiered double-digit royalties. These transactions represent a major step for Alnylam in expanding its therapeutic pipeline and solidifying its financial position.

Key Highlights

  • 1Alnylam entered into a global, strategic collaboration with Regeneron Pharmaceuticals to discover, develop, and commercialize RNAi therapeutics targeting eye and CNS diseases.
  • 2Regeneron will make a $400 million upfront payment and a $400 million equity investment in Alnylam, purchasing shares at $90.00 per share.
  • 3Regeneron's equity investment will result in them owning approximately 4.0% of Alnylam's outstanding common stock.
  • 4The collaboration includes a five-year initial research term, with an option for Regeneron to extend it for up to two additional years.
  • 5Regeneron will lead development and commercialization for eye disease programs, while leadership for CNS and liver programs will alternate, with options for co-development and co-commercialization.
  • 6Alnylam amended its collaboration with Genzyme, concluding the research phase for ALN-AT3 (fitusiran) and transitioning a rare genetic disease asset to Genzyme for future development and commercialization, with Alnylam eligible for tiered royalties.
  • 7The Genzyme agreement amendment also releases Genzyme from certain lock-up restrictions and modifies standstill and voting provisions.

Frequently Asked Questions

The Regeneron collaboration provides Alnylam with a substantial immediate financial boost, including a $400 million upfront payment and a $400 million equity investment. This investment at $90.00 per share is non-dilutive to the extent of the upfront payment and will increase Alnylam's cash reserves, supporting its ongoing research and development efforts. Regeneron's equity purchase will represent approximately 4.0% of Alnylam's outstanding shares post-transaction.

The collaboration focuses on discovering, developing, and commercializing RNAi therapeutics for eye and CNS diseases, with provisions for select liver targets. Regeneron will lead eye programs, while CNS and liver programs will involve shared leadership and co-development/co-commercialization options. Regeneron will provide research funding and potential milestone payments to Alnylam, creating a robust partnership for advancing novel RNAi therapies.

The amendment with Genzyme signifies the transition of the ALN-AT3 (fitusiran) program's research phase. Alnylam will advance a rare genetic disease asset through IND-enabling studies at its own cost, then transfer it to Genzyme, which will bear all future development and commercialization expenses. Alnylam stands to earn tiered double-digit royalties on global net sales if the asset is approved, potentially generating future revenue without direct ongoing R&D expenditure for this specific program.

These agreements are strategically significant as they significantly de-risk Alnylam's pipeline development. The Regeneron collaboration provides substantial funding and expertise for high-potential therapeutic areas (eye, CNS), while the Genzyme amendment allows Alnylam to monetize an asset by transferring future development costs while retaining royalty upside. Both deals strengthen Alnylam's financial position and allow it to focus resources on other key pipeline programs.