Establishment Labs 2024年度报告

UNITED STATESSECURITIES AND EXCHANGE COMMISSIONWashington, D.C. 20549FORM 10-K ☒ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 or TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from___________ to ___________Commission File Number: 001-38593 Establishment Labs Holdings Inc. (Exact name of Registrant as specified in its charter) State or Other Jurisdiction of Incorporation or Organization Building B23 and B25Coyol Free ZoneAlajuelaCosta Rica Not applicable +506-2434-2400Registrant’s Telephone Number, Including Area Code Securities registered pursuant to Section 12(b) of the Act: Title of Each ClassTradingSymbol(s)Name of Each Exchange on WhichRegistered 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 if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the 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 SecuritiesExchange Act of 1934 during the preceding 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 90 days. Yes☒No☐ Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuantto Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrantwas 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, a smaller reportingcompany, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer”, “smaller reportingcompany”, and "emerging growth company" in Rule 12b-2 of the Exchange Act. (Check one) Large accelerated filer☒Non-accelerated filer☐ Accelerated filer☐Smaller reporting company☐Emerging growth company☐ If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period forcomplying with any new or revised financial 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 effectivenessof its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registeredpublic accounting firm that prepared or issued its audit report. Yes☒No☐ If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrantincluded in the filing reflect the correction 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-basedcompensation received by an of the registrant’s executive officers during the relevant recovery period pursuant to (§240.10D-1(b)).☐ Indicate by check mark whether the registrant is a shell company (as defined in Exchange Act Rule 12b-2).Yes☐No☒ The aggregate market value of the common stock held by non-affiliates of the registrant on June 28, 2024, the last business day of theregistrant’s most recently completed second fiscal quarter, was approximately $844,731,145. Shares of the registrant’s common stockheld by each executive officer, director and holder of 10% or more of the outstanding common stock have been excluded in that suchpersons may be deemed to be affiliates. This calculation does not reflect a determination that certain persons are affiliates of theregistrant for any other purpose. The registrant has no non-voting equity. As of February 27, 2025, the number of the registrant’s common shares outstanding was 28,845,813. DOCUMENTS INCORPORATED BY REFERENCE Portions of the registrant’s definitive proxy statement relating to its 2025 annual meeting of shareholders (the “2025 Proxy Statement”)are incorporated by reference into Part III of this Annual Report on Form 10-K where indicated. The 2025 Proxy Statement will be filedwith the U.S. Securities and Exchange Commission within 120 days after the end of the fiscal year to which this report relates. TABLE OF CONTENTS PageExplanatory Note1Special Note Regarding Forward-Looking Statements1Summary Risk Factors1PART I4Item 1.Business4Item 1A.Risk Factors29Item 1B.Unresolved Staff Comments63Item 1C.Cybersecurity63Item 2.Properties64Item 3.Legal Proceedings64Item 4.Mine Safety Disclosures64PART II64Item 5.Market for Registrant’s Common Equity, Related Stockholder Matters and IssuerPurchases of Equity Securities64Item 6.R