For example, on May 12, 2025, President Trump issued an Executive Order directing federal agencies including the Department of Health and Human Services (“HHS”) to pursue a “most-favored-nation” (“MFN”) pricing policy for certain prescription drugs, which would tie prices paid by Medicare to the lowest price available in certain other developed countries. The scope, timing, and implementation details of the MFN policy remain uncertain and may be subject to legal challenges, regulatory rulemaking, and changes in administrative priorities. If implemented, this policy could have a material impact on the pricing and reimbursement of our products in the United States, particularly those covered under Medicare Part B or Part D. Potential effects include reduced pricing flexibility, downward pressure on reimbursement rates, and changes to market access dynamics. The MFN policy could also influence pricing negotiations with commercial payors and international markets. Because the outcome, timing, and specifics of this policy are uncertain, we cannot predict its ultimate effect on our business, financial condition, results of operations, or prospects, but the impact could be material and adverse.
