Our results of operations could be adversely affected by the Patent Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, or collectively, the ACA, the Inflation Reduction Act of 2022, or the IRA, and by other healthcare legislative reforms that may be enacted or adopted in the future, particularly in light of the recent U.S. Presidential and Congressional elections. We expect to experience pricing pressures in connection with the sale of any of our product candidates, due to the trend toward managed healthcare, the increasing influence of health maintenance organizations and additional legislative changes. The downward pressure on healthcare costs in general, particularly prescription drugs and other treatments, has become very intense. As a result, increasingly high barriers are being erected to the entry of new products.
