Establishment Labs 2025年季度报告

FORM10-Q (Mark One) ☒QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934For the quarterly period endedJune 30, 2025. OR ☐TRANSITIONREPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934For the transition period from ___________ to ___________ Commission File Number:001-38593 Establishment Labs Holdings Inc. (Exact name of Registrant as specified in its charter) 98-1436377 I.R.S. Employer Identification No. +506 2434 2400 Registrant’s Telephone Number, Including Area Code Not applicable Former Name, Former Address and Former Fiscal Year, if Changed Since Last Report 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, 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. Large accelerated filer☒Non-accelerated filer☐Emerging growth company☐ Accelerated filer☐Smallerreportingcompany☐ 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 is a shell company (as defined in Rule12b-2 of the Act).Yes☐No☒ Securities registered pursuant to Section 12(b) of the Act: The number of the registrant’s common shares outstanding as of August6, 2025 was28,970,736. TABLE OF CONTENTS PageExplanatory Note1Special Note about Forward-Looking Statements1Summary of Risk Factors2PartI. Financial Information4Item 1.Financial Statements - Unaudited4Condensed Consolidated Balance Sheets as of June 30, 2025 and December 31, 20244Condensed Consolidated Statements of Operations for the Three and Six Months Ended June 30,2025 and 20245Condensed Consolidated Statements of Comprehensive Loss for the Three and Six Months EndedJune 30, 2025 and 20246Condensed Consolidated Statements of Shareholders’ Equity for the Three and Six Months EndedJune 30, 2025 and 20247Condensed Consolidated Statements of Cash Flows for the Six Months Ended June 30, 2025 and20249Notes to the Condensed Consolidated Financial Statements11Item 2.Management’s Discussion and Analysis of Financial Condition and Results of Operations39Item 3.Quantitative and Qualitative Disclosures About Market Risk50Item 4.Controls and Procedures50Part II. Other Information51Item 1.Legal Proceedings51Item 1A.Risk Factors51Item 2.Unregistered Sales of Equity Securities and Use of Proceeds85Item 3.Defaults Upon Senior Securities85Item 4.Mine Safety Disclosure85Item 5.Other Information85Item 6.Exhibits85Signatures87 EXPLANATORY NOTE In this report, unless the context indicates otherwise, the terms “Establishment Labs,” “Company,” “we”, “us” and “our”refer to Establishment Labs Holdings Inc., a British Virgin Islands entity, and its consolidated subsidiaries. We own, or have rights to, trademarks and trade names that we use in connection with the operation of our business,including Establishment Labs and our logo as well as other brands such as Motiva Implants, SilkSurface/SmoothSilk,VelvetSurface, ProgressiveGel, TrueMonobloc, BluSeal, Divina, Ergonomix, Ergomonix2, Ergonomix2 Diamond, MiaFemtech, MotivaImagine, GEM, Zen and Preservé, among others. Other trademarks and trade names appearing in thisreport are the property of their respective owners. Solely for your convenience, some of the trademarks and trade namesreferred to in this report are listed without the ® and TM symbols, but we will assert, to the fullest extent under applicablelaw, our rights to our trademarks and trade names. SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS This report contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, asamended, and Section 21E of the Securities Exchange Act of 1934, as amended or the Exchange Act. You can find many(but not all) of these statements by looking for words such as “approximates,” “believes,” “expects,” “anticipates,”“estimates,” “intends,” “plans,” “would,” “may” or other similar expressions in this report. Any statements that refer