Our ability to successfully commercialize our product will depend on the extent to which governmental authorities, private health insurers, and other organizations establish what we believe are appropriate coverage and reimbursement for our product. The containment of healthcare costs has become a priority of governments worldwide, and the prices of drug products have been a focus in this effort. For example, President Trump has signed multiple executive orders addressing prescription drug pricing and access, including one in May 2025 aiming to establish a “most favored nation” (“MFN”) drug pricing policy, which would tie U.S. drug prices to the lowest prices paid for drugs in other countries. Certain manufacturers have entered into voluntary agreements with the Trump Administration on MFN pricing, and the Centers for Medicare & Medicaid Services has announced initiatives that would take steps to implement MFN pricing for Medicaid and Medicare Parts B and D programs. Adoption or expansion of MFN pricing policies could result in downward pressure on U.S. pricing and may impact our decision about when or whether to launch MOLBREEVI in markets outside of the U.S., if approved.
