Product reimbursement and coverage policies and practices, pricing regulations and requirements, and our pricing strategy could change due to various factors beyond our control, which may adversely impact our business, prospects, operating results, and financial condition… For example, in May 2025, an executive order directed the U.S. Department of Health and Human Services (“HHS”) and other federal agencies to take certain steps intended to, among other things, reduce the prices of drugs sold in the United States to match the lowest price available for the same drugs in comparably developed nations (commonly referred to as “most-favored-nation” (“MFN”) pricing).
