EDAP TMS SA ADR 2025年度报告

Securities registered pursuant to Section 12(b) of the Act: Securities registered pursuant to Section 12(g) of the Act:None Indicate by check mark if the Registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes☐No☒ Indicate by check mark whether the Registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during thepreceding 12 months (or for such shorter period that the Registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90days. Yes☒No☐ Indicate by check mark whether the Registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T(§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the Registrant was required to submit such files). Yes☒No☐ Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growthcompany. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of theExchange Act. If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revisedfinancial accounting standards provided pursuant to Section 13(a) of the Exchange Act.☐ Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financialreporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report.☐ If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect thecorrection of an error to previously issued financial statements.☐ Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of theregistrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b).☐ The aggregate market value of the voting and non-voting common equity held by non-affiliates based on the closing price per American Depositary Share, or ADS, of theregistrant’s ADSs on The Nasdaq Global Market on June 30, 2025 (the last business day of the registrant’s most recently completed second fiscal quarter) was$61,845,277. As of March 25, 2026, the registrant had 37,481,986 ordinary shares, nominal value €0.13 per share, outstanding. TABLE OF CONTENTS PART IItem 1. Business. 3Item 1A. Risk Factors.18Item 1B. Unresolved Staff Comments.41Item 1C. Cybersecurity.42Item 2. Properties.43Item 3. Legal Proceedings.43Item 4. Mine Safety Disclosures.43PART IIItem 5. Market for Registrant’s Common Equity, Related Stockholder Matters and IssuerPurchases of Equity Securities.44Item 6. [Reserved].44Item 7. Management’s Discussion and Analysis of Financial Condition and Results ofOperations.44Item 7A. Quantitative and Qualitative Disclosures About Market Risk.52Item 8. Financial Statements and Supplementary Data.F-1Item 9. Changes in and Disagreements with Accountants on Accounting and FinancialDisclosure.53Item 9A. Controls and Procedures.53Item 9B. Other Information.54Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections.56PART IIIItem 10. Directors, Executive Officers and Corporate Governance.57Item 11. Executive Compensation.63Item 12. Security Ownership of Certain Beneficial Owners and Management and RelatedStockholder Matters.69Item 13. Certain Relationships and Related Transactions, and Director Independence.71Item 14. Principal Accountant Fees and Services.72PART IVItem 15. Exhibits and Financial Statement Schedules.73Item 16. Form 10-K Summary74 CAUTIONARY STATEMENT ON FORWARD-LOOKING STATEMENTS The statements contained in this Annual Report on Form10-K (this “Annual Report”) discuss our futureexpectations, contain projections of our results of operations or financial condition, and include otherforward-looking information within the meaning of Section27A of the Securities Act of 1933, as amended(the “Securities Act”) and Section21E of the Exchange Act. Our actual results may differ materially fromthose expressed in forward-looking statements made or incorporated by reference into this Annual Report. All statements other than present and historical facts and conditions, including forward-looking statementsexpressing our beliefs, plans, objectives, business strategy, or future events, performance or results ofoperations and financial position, are forward-looking statements, which involve estimates, assumptions,risks and uncertainties. Therefore, our actual