Establishment Labs 2025年度报告

ANNUAL REPORT PURSUANT TO SECTION13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2025 or ☐TRANSITION REPORT PURSUANT TO SECTION13 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) British Virgin Islands98-1436377 Suite 400Austin, Texas78758Address of Principal Executive OfficesZip Code Title of Each ClassTrading Symbol(s)Name of Each Exchange on Which Registered 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 Rule405 of the Securities Act.Yes☒No☐ Indicate by check mark if the registrant is not required to file reports pursuant to Section13 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 Section13 or 15(d) of the SecuritiesExchange Act of 1934 during the preceding 12months (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 pursuantto Rule405 of RegulationS-T (§232.405 of this chapter) during the preceding 12months (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☐Smallerreportingcompany☐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 any 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 Rule12b-2).Yes☐No☒ The aggregate market value of the common stock held by non-affiliates of the registrant on June 30, 2025, the last business day of theregistrant’s most recently completed second fiscal quarter, was approximately $975,097,617. 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 February26, 2026, the number of the registrant’s common shares outstanding was 29,320,846. DOCUMENTS INCORPORATED BY REFERENCE Portions of the registrant’s definitive proxy statement relating to its 2026 annual meeting of shareholders (the “2026 Proxy Statement”)are incorporated by reference into Part III of this Annual Report on Form 10-K where indicated. The 2026 Proxy Statement will be filedwith the U.S. Securities and Exchange Commission within 120days after the end of the fiscal year to which this report relates. TABLE OF CONTENTS Explanatory NoteSpecial Note Regarding Forward-Looking StatementsSummary of Risk FactorsPARTIItem 1.BusinessItem 1A.Risk FactorsItem 1B.Unresolved Staff CommentsItem 1C.CybersecurityItem 2.PropertiesItem 3.Legal ProceedingsItem 4.Mine Safety DisclosuresPART IIItem 5.Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases ofEquity SecuritiesItem 6.ReservedItem 7.Management’s Discussion and Analysis of Financial Condition and Results of OperationsItem 7A.Quantitative and Qualitative Disclosures about Market RiskItem 8.Financial Statements and Supplement