In addition, in May 2025, the U.S. administration issued an executive order intended to encourage or impose the use of “Most Favored Nation” (MFN) pricing in the U.S. market. MFN is a price-setting mechanism, which generally would tie U.S. prescription drug prices to the lowest price available in selected “comparably developed nations.” Since such order was issued, the U.S. administration has negotiated agreements with a number of biopharmaceutical companies implementing MFN pricing in certain respects, and has proposed pilot programs for Medicare and Medicaid that would apply MFN pricing to drugs sold through those programs. While the actual impact cannot yet be fully estimated with certainty, MFN pricing in the U.S. market could, among other things, result in the reduction of the prices of our products in the U.S., which could in turn materially and adversely impact our business, financial condition and results of operations. Various state legislatures and regulators have also enacted, or are pursuing, policy changes that could further increase pricing pressure on our products (e.g., prescription drug affordability boards, limited distribution network policies). As a result, we expect the healthcare industry in the U.S. will continue to be subject to increased pricing and spending pressure and our products could face adverse impacts in the U.S.
