We may not be able to adequately price our product or obtain third-party reimbursement for the cost of our product, which would adversely affect our sales and profitability. The healthcare industry is subject to significant regulatory reforms and cost containment pressures that could materially affect our business. In the U.S., there has been increasing legislative and regulatory focus on controlling pharmaceutical pricing. At the federal level, Congress passed the Inflation Reduction Act of 2022 (the “IRA”), which includes provisions that authorize the Secretary of Health and Human Services to negotiate prices with pharmaceutical companies for certain high-expenditure, single-source drugs covered under Medicare Part B or Part D programs, and provisions that impose rebates under Medicare Part B or Part D to penalize price increases that outpace inflation.
