Additionally, on May 12, 2025, the current administration issued an executive order entitled, “Delivering Most-Favored Nation Prescription Drug Pricing to American Patients,” which, among various proposals, directs the HHS to facilitate direct-to-consumer purchasing programs for pharmaceutical manufacturers that sell their products to American patients at the most-favored-nation price and to propose a rulemaking plan to impose most-favored-nation pricing, including most-favored-nation pricing targets to bring U.S. drug prices in line with the prices of comparably developed nations. The implementation of these and other cost containment measures, including the prescription drug provisions under the IRA, as well as other healthcare reforms may prevent us from being able to generate revenue, attain profitability, or commercialize our product candidates if approved. Uncertainties created by the IRA and other cost containment measures, including most-favored-nation pricing and international reference drug pricing, may negatively impact potential investments, company valuation, royalty-based earnings, mergers and acquisitions in our industry.
