Company: ICUI
Filing Date: 2025-02-27
Form Type: 10-K
Source: 0000883984-25-000007
Chunk: 154

Company: ICU MEDICAL INC/DE
Filing Date: 2025-02-27
Form: 10-K
Item: Item 1
Chunk 154
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, potential loss of export licenses, possible suspension of the ability to do business with the federal government, denial of government reimbursement for products and exclusion from participation in government healthcare programs. We operate in jurisdictions that have experienced governmental and private sector corruption to some degree, and, in certain circumstances, strict compliance with anti-bribery laws may conflict with certain local customs and practices. We cannot assure that our internal control policies and procedures always will protect us from reckless or other inappropriate acts committed by our affiliates, employees, distributors or other agents. Violations of these laws, or allegations of such violations, could have a material adverse effect on our business, financial position and results of operations. 

We are subject to risks associated with doing business outside of the U.S.

We operate in a global market and global operations are subject to a number of risks. Sales to customers outside of the U.S. composed approximately 36% of our revenues in 2024 and as our operations and sales located in Europe and other areas outside the U.S. increase, we may face new challenges and uncertainties, although we can give no assurance that such operations and sales will increase. 

The risks associated with our operations outside the U.S. include, without limitation:

•economic and political uncertainty;

•changes in non-U.S. government programs;  

•multiple non-U.S. regulatory requirements that are subject to change and that could restrict our ability to manufacture and sell our products;  

•different local medical practices, product preferences and product requirements; 

•possible failure to comply with trade protection and restriction measures and import or export licensing requirements; 

•difficulty in establishing, staffing and managing non-U.S. operations; 

•different labor regulations or work stoppages or strikes; 

•changing geopolitical conditions arising from political instability and any actual or anticipated military or political conflicts; 

•economic instability in other parts of the world and the impact on interest rates, inflation and the credit worthiness of our customers in foreign countries, such as the devaluation of the Argentine Peso;

•tariffs on products imported to the U.S.;

•uncertainties regarding judicial systems and procedures; 

•minimal or diminished protection of intellectual property in some countries;

•natural disasters or outbreak of diseases or pandemics;

•fluctuations in foreign currency exchange rates;

•changes to international trade agreements and trade relationships and conflicts between countries; and

•imposition of government controls, such as economic sanctions and export controls.

These risks, individually or in the aggregate, could have an adverse effect on our