LivaNova PLC

Other than as described below, there have been no material changes in LivaNova’s risk factors from those disclosed in Part I, Item 1A of the Company’s 2024 Annual Report on Form 10-K.

Adverse changes in export and import costs and other trade restrictions as well as uncertainty over global tariffs could materially adversely affect LivaNova’s business and results of operations.

Recently, the U.S. government announced substantial changes in U.S. trade policy and trade agreements, including imposing tariffs on certain foreign goods. In response to these tariffs, certain foreign governments, including China, have retaliated by imposing tariffs on certain U.S. goods. A significant number of LivaNova’s Cardiopulmonary products and component parts are sourced and produced outside of the U.S., including in Italy and Germany. Similarly, LivaNova manufactures its Neuromodulation products in the U.S., which are then often distributed internationally. To the extent tariffs or other similar trade restrictions are implemented by the U.S., other countries, and/or trade blocs in connection with a global trade war, such actions would increase the cost of LivaNova’s products, which may affect the competitiveness of the Company’s products relative to manufacturers not affected by such actions. Increased tariffs could require LivaNova to increase its prices, which could decrease demand for its products, and in certain cases, the Company may be unable to implement price increases. While the Company continues to assess these developments, it may not be able to fully mitigate the impacts of tariffs. Further, uncertainty surrounding the scope and duration of trade actions by the U.S. and potential retaliatory trade actions by other countries and/or trade blocs has constrained LivaNova’s ability to fully plan for and implement related mitigation strategies.

The factors described above may have a material adverse effect on LivaNova’s business, results of operations, cash flows, and financial condition.