8-KEarnings & ResultsMaterial AgreementsRegulation FD+1

ALNYLAM PHARMACEUTICALS, INC. 8-K Report, Material Agreement (Jan 8, 2018)

Filed January 8, 2018For Securities:ALNY

Summary

Alnylam Pharmaceuticals, Inc. (ALNY) has entered into a significant amendment to its Master Collaboration Agreement with Genzyme Corporation, restructuring their partnership for key RNAi therapeutic programs. This amendment grants Alnylam exclusive global rights to develop and commercialize all transthyretin (TTR) products, including the lead candidate patisiran (ALN-TTR02) and its subcutaneous counterpart ALN-TTRsc02. Conversely, Genzyme gains exclusive global rights for ALN-AT3 (fitusiran), a potential treatment for rare genetic diseases, and its backup products. This strategic realignment shifts certain financial responsibilities and potential revenue streams. Alnylam will now bear full development and commercialization costs for its TTR programs, while sharing initial costs for ALN-AT3 with Genzyme, with Genzyme taking over full financial responsibility after a specified transition period. Genzyme will provide Alnylam with a $50 million milestone payment upon the initiation of the ATLAS Phase 3 program for ALN-AT3, and Alnylam will be eligible for tiered royalties on Genzyme's sales of ALN-AT3 and its backups. Conversely, Genzyme will receive tiered royalties on Alnylam's TTR product sales outside specific territories, with varying rates depending on the product and region. This amendment aims to provide clearer development pathways and financial ownership for each company's respective key pipeline assets.

Key Highlights

  • 1Alnylam secures exclusive global rights for TTR programs (patisiran, ALN-TTRsc02) from Genzyme.
  • 2Genzyme receives exclusive global rights for ALN-AT3 (fitusiran) program from Alnylam.
  • 3Alnylam assumes full funding responsibility for TTR product development and commercialization.
  • 4Genzyme to make a $50 million milestone payment to Alnylam upon initiation of ALN-AT3 Phase 3 program (ATLAS).
  • 5Alnylam eligible for tiered royalties (15-30%) on Genzyme's global net sales of ALN-AT3 and backups.
  • 6Genzyme eligible for tiered royalties (up to 25%) on Alnylam's global net sales of patisiran and ALN-TTRsc02 (outside specified territories).
  • 7Alnylam updates 2017 year-end cash guidance, expecting over $1.7 billion in cash, cash equivalents, marketable securities, and restricted cash.

Frequently Asked Questions

The amendment grants Alnylam exclusive global rights to develop and commercialize all TTR products, including patisiran (ALN-TTR02) and ALN-TTRsc02. Alnylam will now be solely responsible for all associated development and commercialization costs, and Genzyme will be eligible to receive tiered royalties on Alnylam's sales of these products in certain territories.

Genzyme gains exclusive global rights for ALN-AT3. Alnylam will fund development and commercialization costs through a transition period up to a specified cap, after which Genzyme assumes all costs. Genzyme will make a $50 million milestone payment to Alnylam and Alnylam will be eligible to receive tiered royalties (15-30%) on Genzyme's global net sales of ALN-AT3 and its back-up products.

Alnylam expects to end 2017 with over $1.7 billion in cash, cash equivalents, marketable securities, and restricted cash. While the agreement involves future royalty payments and milestone receipts/payments, the primary financial impact disclosed in this filing relates to the restructuring of collaboration terms and associated development cost responsibilities.

Yes, the transaction is subject to customary closing conditions and clearances, including clearance under the Hart-Scott-Rodino Antitrust Improvements Act.