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AMGEN INC 8-K Report, Material Agreement (Jun 1, 2021)

Filed June 1, 2021For Securities:AMGN

Summary

Amgen Inc. (AMGN) has entered into a significant License and Collaboration Agreement with Kyowa Kirin Co., Ltd. (KKC) concerning the development and commercialization of KHK4083, a fully human monoclonal antibody targeting OX40. This agreement grants Amgen worldwide rights (excluding Japan) to lead development, manufacturing, and commercialization of the product. This collaboration represents a strategic move for Amgen to expand its pipeline in inflammation-related diseases. The financial implications of this deal include an upfront payment of $400 million from Amgen to KKC, with potential future milestone payments reaching up to $850 million. Amgen will also pay significant tiered royalties on net sales. The shared development and U.S. commercialization costs, along with Amgen booking all revenue in its territory, highlight the financial commitment and potential upside for Amgen, while KKC retains co-promotion rights in the U.S. and South Korea, and opt-in rights for other markets.

Key Highlights

  • 1Amgen enters a global collaboration (ex-Japan) with Kyowa Kirin Co., Ltd. for KHK4083, an anti-OX40 monoclonal antibody.
  • 2Amgen will lead development, manufacturing, and commercialization, with KKC co-promoting in the U.S. and co-marketing in South Korea.
  • 3The agreement involves an immediate $400 million upfront payment from Amgen to KKC.
  • 4Future contingent milestone payments could reach up to $850 million.
  • 5Amgen will also pay significant tiered royalties on net sales to KKC.
  • 6Development and U.S. commercialization costs will be shared between Amgen and KKC.
  • 7Amgen will book all revenue from sales in its territory.

Frequently Asked Questions

KHK4083 is a fully human monoclonal antibody that targets OX40. While the filing doesn't detail the specific indication, it is expected to treat inflammation-related diseases, suggesting potential in various autoimmune or inflammatory conditions.

Amgen is making a $400 million upfront payment, with potential future milestone payments up to $850 million. Additionally, Amgen will pay significant tiered royalties on net sales and share global development costs and U.S. commercialization costs.

Kyowa Kirin (KKC) will co-promote KHK4083 in the U.S. and co-market it in South Korea, with opt-in rights for co-promotion in certain other international markets. KKC will also receive the upfront payment, potential milestone payments, and royalties on sales.

Amgen has global rights to develop and commercialize KHK4083, excluding Japan. KKC will retain rights in Japan, and will have co-promotion/co-marketing rights in specified regions.