Cosmos Health's biggest risks in the FY2024 10-K
- International operations expose the company to 100% foreign net sales and currency exchange fluctuations.
- Regulatory approval processes for drugs and vaccines are lengthy, costly, and unpredictable.
- Clinical trial patient recruitment and enrollment present ongoing operational hurdles.
The risks most specific to Cosmos Health
- Regulatory and Litigation Risks
Currency exchange rate fluctuations could adversely affect our results of operation and financial condition
In 2024, 100% of net sales occurred outside the United States in local currencies while inventory is purchased partly in U.S. dollars.
- Regulatory and Litigation Risks
Geopolitical issues, conflicts and other global events could adversely affect our results of operations and financial condition
Conducting business outside the U.S. exposes operations to geopolitical conflicts such as the war in Ukraine.
- Regulatory and Litigation Risks
Inflation and rising interest rates in the EU
EU annual inflation reached 2.4% in December 2024, down from 3.4% in 2023.
- Regulatory and Litigation Risks
Inflation Reduction Act of 2022 in the U.S
The U.S. Inflation Reduction Act of 2022 caps Medicare Part D out-of-pocket spending at $2,000 starting in 2025 and imposes new manufacturer financial liabilities.
- Regulatory and Litigation Risks
Development, regulatory approval & marketing of products
The discovery, clinical development, and regulatory approval of drugs, vaccines, and biological products are time-consuming, costly, and unpredictable.
- Regulatory and Litigation Risks
We may have difficulties recruiting and enrolling patients for clinical trials on a consistent basis
Difficulties in recruiting and enrolling patients for clinical trials consistently could cause product candidates to fail.
- Regulatory and Litigation Risks
We may not be able to successfully address all the comments received from regulatory authorities such as the FDA and the EMA, or be able to obtain approval for new products and indications from regulators
Failure to address FDA and EMA comments or secure regulatory approvals for new products and indications threatens commercialization.
All 12 risk factors
Headings as the filing states them, in filing order.
Regulatory and Litigation Risks
- 01Taxation and transfer pricing could adversely affect our results of operations and financial condition
- 02Changes in consumer behavior
- 03Management of further developments
- 04Currency exchange rate fluctuations could adversely affect our results of operation and financial condition
- 05Geopolitical issues, conflicts and other global events could adversely affect our results of operations and financial condition
- 06Climate change and related legislation or regulations may adversely impact our business, including potential financial, operational and physical impacts
- 07Cybersecurity risks and the failure to maintain the integrity of data could expose us to data loss, litigation and liability, which could adversely affect our results of operations and financial condition
- 08Inflation and rising interest rates in the EU
- 09Inflation Reduction Act of 2022 in the U.S
- 10Development, regulatory approval & marketing of products
- 11We may have difficulties recruiting and enrolling patients for clinical trials on a consistent basis
- 12We may not be able to successfully address all the comments received from regulatory authorities such as the FDA and the EMA, or be able to obtain approval for new products and indications from regulators
Other Cosmos Health 10-Ks
- FY2025 10-K risk factors13 risks1 new2 reworded
Cosmos Health faces new pricing and tariff pressure from the U.S. Inflation Reduction Act. EU inflation metrics and interest rate risks were updated with 2025 data. Foreign currency risks now account for initial US sales of the Sky Premium Life brand.
Filed Apr 15, 2026
About this page
The headings are the filing's own. The one-line readings and the overview are automated and can be wrong: read Item 1A of the 10-K for the exact wording.