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ALNYLAM PHARMACEUTICALS, INC. 8-K Report, Material Agreement (Jul 26, 2023)

Filed July 26, 2023For Securities:ALNY

Summary

Alnylam Pharmaceuticals, Inc. (ALNY) has entered into a significant strategic collaboration with Roche Basel and Genentech, Inc. (collectively, Roche) for the joint development and commercialization of zilebesiran, an siRNA therapeutic targeting liver-expressed angiotensinogen (AGT). This agreement grants Roche co-exclusive rights in the United States and exclusive rights outside the U.S. for development and commercialization. This deal provides Alnylam with a substantial upfront payment of $310 million and positions the company to receive up to an additional $2.5 billion in contingent milestone payments. While Alnylam will retain marketing authorization in the U.S. and share profits and losses (50/50) within the U.S., Roche will handle marketing and bear the costs in the Roche Territory, paying Alnylam tiered, low double-digit royalties. This collaboration signifies a key step for Alnylam in advancing zilebesiran, potentially de-risking development and expanding its global reach.

Key Highlights

  • 1Alnylam has entered a global strategic collaboration with Roche for its siRNA therapeutic, zilebesiran (targeting AGT).
  • 2Roche gains co-exclusive rights in the U.S. and exclusive rights outside the U.S. for zilebesiran development and commercialization.
  • 3Alnylam receives an upfront payment of $310 million from Roche.
  • 4The company is eligible for up to $2.5 billion in future milestone payments based on development, regulatory, and sales achievements.
  • 5Alnylam will retain U.S. marketing authorization and share U.S. profits/losses 50/50 with Roche.
  • 6Roche will be responsible for commercialization costs outside the U.S. and will pay Alnylam tiered, low double-digit royalties on net sales in its territory.
  • 7The agreement outlines a shared responsibility for development costs, with Alnylam responsible for 40% of global development costs and 50% of U.S.-specific development costs.

Frequently Asked Questions

Alnylam receives an immediate upfront payment of $310 million and is eligible to receive up to $2.5 billion in future milestone payments tied to the successful development, regulatory approval, and commercialization of zilebesiran. Additionally, Alnylam will receive tiered, low double-digit royalties on net sales outside the U.S. and will share equally in profits and losses within the U.S.

Alnylam will have primary operational responsibility for certain clinical trials and development for hypertension. Development costs for global regulatory approvals will be shared (40% Alnylam, 60% Roche), while U.S.-specific development costs will be split 50/50. Alnylam will retain U.S. marketing authorization and share U.S. profits/losses 50/50. Roche will be responsible for development and commercialization outside the U.S., paying Alnylam royalties.

This collaboration significantly expands the potential reach and de-risks the development and commercialization of zilebesiran by partnering with a global pharmaceutical giant like Roche. It allows Alnylam to leverage Roche's extensive global infrastructure and resources while retaining significant upside in the key U.S. market.

Roche may terminate the agreement without cause upon notice. Either party can terminate due to the other party's insolvency or material breach (subject to a cure period). Alnylam can also terminate if Roche challenges certain patents licensed under the agreement.