03/25/2026 | Press release | Distributed by Public on 03/25/2026 06:01
Item 7.01. Regulation FD Disclosure
On March 18, 2026, MiniMed Group, Inc. ("MiniMed") announced that the U.S. Food and Drug Administration (the "FDA") has cleared the MiniMed Flex™, a next-generation discreet, smartphone-controlled insulin pump. The clearance of the MiniMed Flex by the FDA was several months earlier than anticipated, and will facilitate the earlier commercialization of this key MiniMed product.
The research and development of the MiniMed Flex was funded in part by affiliates of Blackstone Life Sciences Advisors L.L.C. ("Blackstone"). Under the research and development agreement between MiniMed and Blackstone, in exchange for funding the development of the MiniMed Flex, during the first two years following regulatory approval in the U.S. and commercial launch of the MiniMed Flex, Blackstone will earn the greater of: (i) mid-to-high single digit royalty percentage of applicable net sales, and (ii) a specified minimum payment of $157 million for this product. MiniMed is expected to recognize a one-time charge of $157 million in the fourth quarter of fiscal year 2026 related to the series of future payments due to Blackstone for this product.