Further, the Trump administration has introduced aggressive pricing initiatives through executive order and otherwise that create new revenue risks, including Most-Favored-Nation (MFN) Pricing that would compel manufacturers to align U.S. prices with the lowest paid in “economic peer countries” (e.g., UK, France, Germany, Japan). This could reduce the ultimate price that we receive for Annamycin, which could negatively affect our business, results of operations, financial conditions, and prospects. We expect that changes or additions to the ACA, IRA OBBBA, MFN pricing or their implementing regulations or guidance, changes to the Medicare and Medicaid programs, changes regarding the federal government’s authority to directly negotiate drug prices and changes stemming from other healthcare reform measures, especially with regard to healthcare access or financing or other legislation in individual states, could have a material adverse effect on the healthcare industry and our business.
