In 2025, the Trump Administration issued executive actions and supported regulatory initiatives focused on implementing most-favored-nation, or MFN, pricing concepts and expanding direct-to-consumer sales models, and CMS proposed multiple reimbursement models that would incorporate international reference pricing benchmarks into Medicare and Medicaid payment structures. These initiatives, if implemented, could adversely affect the prices that manufacturers are able to obtain for prescription drugs in the United States. Although certain proposals remain subject to rulemaking, legal challenge, or voluntary participation, continued efforts to regulate or constrain drug pricing could materially impact our future revenue, pricing flexibility, and commercial strategy if our product candidates are approved.
