On April 15, 2025, President Trump issued an Executive Order which directs HHS to take steps to reduce the prices of pharmaceutical products. Subsequently, on May 12, 2025, President Trump issued an additional Executive Order calling on pharmaceutical manufacturers to voluntarily reduce the prices of medicines in the United States. The Executive Order directs the Secretary of HHS to communicate most-favored-nation (MFN) price targets to pharmaceutical manufacturers to bring prices in line with comparably developed nations. The Executive Order further provides that if such actions do not lower the costs of pharmaceuticals, the Secretary of HHS would pursue other actions, including proposing a rulemaking that imposes MFN pricing in the United States. The implications of these actions remain unclear, however, these regulatory developments, depending on whether and how they may be enacted, as well as others that may be adopted in the future, may result in downward pressure on the price that we receive for IBSRELA and XPHOZAH. Accordingly, such measures, if enacted, could have an adverse effect on our revenue and may affect our overall financial condition and ability to commercialize our products profitably.
