What the changes say
- 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.
What changed since the prior 10-K
New
- NewRegulatory and Litigation Risks
Most-Favoured-Nation (MFN) Pricing and Section 232 Tariffs
The Inflation Reduction Act introduces Medicare price caps, manufacturer liabilities, and inflation rebates while delaying the PBM rebate rule until 2032.
Reworded
- 93% rewrittenRegulatory and Litigation Risks
Inflation and rising interest rates in the EU
Updated EU inflation data to December 2025 at 2.3% and the 2016-2025 HICP average to 2.6%, noting costs remain elevated despite moderation.
- 29% rewrittenRegulatory and Litigation Risks
Currency exchange rate fluctuations could adversely affect our results of operation and financial condition
Added that over 98 percent of net sales remain outside the US following initial US sales through the Sky Premium Life nutraceutical brand.
All 13 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 condition29% rewritten
- 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 EU93% rewritten
- 09Inflation Reduction Act of 2022 in the U.S
- 10Most-Favoured-Nation (MFN) Pricing and Section 232 TariffsNew
- 11Development, regulatory approval & marketing of products
- 12We may have difficulties recruiting and enrolling patients for clinical trials on a consistent basis
- 13We 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
- FY2024 10-K risk factors12 risks
International operations expose the company to 100% foreign net sales and currency exchange fluctuations.
Filed Apr 15, 2025
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.