OPKO Health Inc

Item 1A. Risk Factors

Unstable economic and market conditions may have adverse consequences on our business and financial condition.

Our business performance may be impacted by a number of factors, including general economic conditions, the geopolitical environment, current or expected inflation, interest rate fluctuations, market volatility and the threat or imposition of broad-based tariffs. Significant developments or changes in national laws or policies to protect or promote domestic interests and/or address foreign competition, including laws and policies in areas such as trade, manufacturing, government purchasing, healthcare, intellectual property, regulatory enforcement and investment/development, can adversely affect our business and financial statements. The current U.S. administration has initiated or is considering imposing tariffs on certain goods. Consequently, certain foreign governments including China, have imposed or are considering imposing reciprocal tariffs on certain U.S. goods. While pharmaceutical products have largely been exempt from the most recent tariffs, such exemptions are likely to be terminated according to statements from the administration. We continue to evaluate the impacts of tariffs on our business and results of operations, but a trade war or other governmental action related to tariffs or international trade agreements or policies has the potential to disrupt our research activities, could raise our cost of goods, and could therefore adversely impact our business and financial condition.

Changes in personnel and funding for government agencies, including the FDA, could negatively impact our business and financial condition.

We rely on the FDA to provide feedback on clinical trials and development programs, review regulatory submissions and ultimately review and approve new products. Significant reductions to the FDAs workforce and budget could constrain the FDAs ability to timely and effectively provide feedback on our products. If disruptions at the FDA and other agencies delays the time necessary for oThere have been no material changes to our risk factors as previously disclosed in our Form 10-K and our product candidates to be reviewed or approved, this delay could prevent our product candidates from being developed or commercialized in a timely manner or otherwise, if at all, which could adversely affect our business and financial condition.

There is also substantial uncertainty as to whether or how the requirements and policies of government agencies including the FDA might be modified. Any significant changes to process or procedures of the FDA could present new challenges to the clinical development and approval process which can in turn affect our ability to timely bring products to market.

Similarly, a portion of our business relies on funding from BARDA. There is significant uncertainty at this time as to whether such funding will remain available to us through clinical trials and for the development life of our product candidates. If the funding is reduced for studies related to the products or indications on which we are focused or on which researchers were or may have been considering applying for federal grants, our research and development initiatives could be delayed or otherwise affected.

Quarterly Report on Form 10-Q for the quarter ended March 31, 2025.