ESTABLISHMENT LABS HOLDINGS INC.

1. Formation and Business of the Company

Establishment Labs Holdings Inc. along with its wholly owned subsidiaries, or the Company, is a global company that manufactures and markets innovative medical devices for aesthetic and reconstructive plastic surgery. The Company was established in the British Virgin Islands on October 9, 2013, at which time Establishment Labs, S.A., the Costa Rican manufacturing company, was reincorporated as a wholly-owned subsidiary. The Company operates through wholly owned subsidiaries in multiple international jurisdictions.

Substantially all of the Company’s revenues are derived from the sale of silicone gel-filled breast implants, branded as Motiva Implants.

The main manufacturing activities are conducted at manufacturing facilities in Costa Rica. In 2024, the Company completed construction of its newest facility. In 2010, the Company began operating under the Costa Rica free zone regime (Régimen de Zona Franca), which provides for reduced income tax and other tax obligations pursuant to an agreement with the Costa Rican authorities.

The Company’s products are approved for sale in Europe, the Middle East, Latin America, Asia and the United States. The Company sells its products internationally through a combination of direct and distributor sales to customers. In October 2024, the Company began selling Motiva Implants for use in breast augmentation for patients in the United States.

2. Summary of Significant Accounting Policies

Basis of Presentation and Consolidation

The accompanying condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America, or GAAP, and the applicable rules and regulations of the Securities and Exchange Commission, or SEC, for interim financial information. Accordingly, they do not include all of the information and notes required by GAAP for complete financial statements.

The accompanying condensed consolidated financial statements and related financial information should be read in conjunction with the audited consolidated financial statements and the related notes thereto for the years ended December 31, 2025, 2024 and 2023 presented in the Company’s Form 10-K filed with the SEC on February 27, 2026.

The condensed consolidated financial statements include the Company’s accounts and those of its wholly owned subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation.

Unaudited Interim Condensed Consolidated Financial Information

The accompanying interim condensed consolidated financial statements as of September 30, 2026 and for the three and nine months ended September 30, 2026 and 2025, and the related interim information contained within the notes to the condensed consolidated financial statements, are unaudited. The unaudited interim condensed consolidated financial statements have been prepared in accordance with GAAP and on the same basis as the audited consolidated financial statements. In the opinion of management, the accompanying unaudited interim condensed consolidated financial statements contain all adjustments which are necessary to state fairly the Company’s financial position as of September 30, 2026, and the results of its operations and cash flows for the nine months ended September 30, 2026 and 2025. Such adjustments are of a normal and recurring nature. The results for the three and nine months ended September 30, 2026 are not necessarily indicative of the results to be expected for the full fiscal year 2026, or for any future period.

Use of Estimates

The preparation of financial statements in accordance with GAAP requires management to make estimates and assumptions that affect the amounts reported in the condensed consolidated financial statements and accompanying notes. Estimates are based on historical experience, where applicable, and other assumptions believed to be reasonable by management. Actual results may differ from those estimates under different assumptions or conditions.

Revenue

Revenue was generated in these primary geographic markets:

Inventory, Net

As of September 30, 2026 and December 31, 2025, $20.7 millionand $14.1 million of inventory was on consignment, respectively.

Recent Accounting Standards

Periodically, new accounting pronouncements are issued by the Financial Accounting Standards Board, or FASB, and adopted by the Company as of the specified effective date. Unless otherwise discussed, the impact of recently issued standards that are not yet effective are not expected to have a material impact on the Company’s consolidated financial statements upon adoption.

Recently Issued Accounting Standards

In November 2024, the FASB issued ASU 2024-03, Disaggregation of Income Statement Expenses, which enhances disclosure requirements over the disaggregation of relevant expense categories within the income statement. The new guidance requires tabular presentation of prescribed expense categories such as the purchases of inventory, employee compensation, depreciation, intangible asset amortization, and other specific expense, gains and losses required by existing GAAP, that reconciles to the face of the income statement. It is effective for annual periods beginning after December 15, 2026 and interim periods beginning after December 15, 2027, with early adoption permitted, and may be applied either prospectively or retrospectively. The Company is currently evaluating the potential effect that the updated standard will have on the financial statement disclosures.

3. Fair Value Measurements

Fair value is defined as the exchange price that would be received for an asset or an exit price paid to transfer a liability in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs.

The fair value hierarchy defines a three-level valuation hierarchy for disclosure of fair value measurements as follows:

•Level I Unadjusted quoted prices in active markets for identical assets or liabilities;

•Level II Inputs other than quoted prices included within Level I that are observable, unadjusted quoted prices in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the related assets or liabilities; and

•Level III Unobservable inputs that are supported by little or no market activity for the related assets or liabilities.

The categorization of a financial instrument within the valuation hierarchy is based upon the lowest level of input that is significant to the fair value measurement.

The following table sets forth the Company’s financial instruments that were measured at fair value on a recurring basis by level within the fair value hierarchy at September 30, 2026:

The fair value measurement of contingent consideration related to the business acquisition completed in fiscal 2024 represents the contingent consideration arrangement from the Company’s acquisition of Motiva Benelux B.V., a distribution company in Belgium, and Motiva NL B.V., a distribution company in Netherlands, on October 1, 2024. Under this contingent consideration arrangement, the Company is required to pay the former owners an amount equal to the total revenue for fiscal year 2024 and 2025 multiplied by a multiple based on the relevant revenue growth rate realized in that particular fiscal year versus the prior year (ratio ranges from 0.5 to 0.9). The potential undiscounted amount of all future contingent payments that the Company could be required to make is not capped.

On April 15, 2026, the Company settled outstanding liabilities and paid $4.8 million as a final settlement, primarily consisting of the contingent consideration for the 2025 milestone and $0.3 million as a final non-contingent contractual payment. The fair value of the contingent consideration arrangement was $4.5 million as of December 31, 2025, which was calculated using the following inputs: (a) 2025 actual revenue of approximately $9.5 million; (b) growth ratio of 0.9 based on average revenue growth over the last two years; and (c) the fact that operating expense targets were met.

The estimates were based, in part, on subjective assumptions. During the periods presented, the Company has not changed the manner in which it values liabilities that are measured at fair value using Level 3 inputs.

The following table sets forth a summary of the changes in the fair value of the Company’s Level 3 financial instruments as follows:

The change in fair value was related to the foreign currency fluctuations.

4. Debt

Amended Oaktree Credit Agreement

Prior to April 30, 2026, the Company was party to a Credit Agreement with Oaktree Fund Administration, LLC, as administrative agent, which provided for up to $225.0 million of secured term loans funded infour tranches. The facility bore interest at rates ranging from 8.25% to 10.0% per annum, was subject to a 2% original issue discount and certain exit and prepayment fees, and was guaranteed by certain subsidiaries of the Company and secured by substantially all of the assets of the Company and the guarantor subsidiaries. The Credit Agreement contained customary affirmative and negative covenants, including minimum liquidity and revenue-based financial covenants.

On April 30, 2026, or the Closing Date, the Company entered into an Amended and Restated Credit Agreement and Guaranty, or the Amended Credit Agreement, together with certain of its subsidiaries as guarantors, the lenders from time to time party thereto and Oaktree Fund Administration, LLC, as administrative agent, pursuant to which the lenders agreed to make term loans to the Company in an aggregate principal amount of up to $300.0 million, or collectively, the New Term Loans. Approximately $259.0 million of the proceeds from the initial borrowing under the Amended Credit Agreement was used to repay all outstanding obligations under the prior Credit Agreement and to pay transaction costs associated with the New Term Loans.

Pursuant to the terms of the Amended Credit Agreement, the New Term Loans will be advanced intwo tranches:

•The first tranche, or the Tranche E Term Loan, was advanced in the amount of $265.0 million on the Closing Date.

•The second tranche, or the Tranche F Term Loan, in an amount up to $35.0 million will be advanced upon the mutual consent of lenders and the Company.

The New Term Loans will mature on April 30, 2031, or the Maturity Date.

The New Term Loans accrue interest at a rate equal to 8.75% per annum, subject to certain conditions. Accrued interest is due and payable in cash on the last business day of March, June, September, and December of each year, commencing on the first such date to occur after the Closing Date; provided, however, that prior to the first anniversary of the Closing Date, the Company may pay an amount of interest on the outstanding New Term Loans corresponding to 25, 50, 75 or 100% of the interest rate in kind, subject to prior written notice delivered to the Administrative Agent. If the Company elects to pay up to 50% of the interest rate in kind for any period, the Company will incur a step-up of 0.375% for such period, which shall be payable in cash, and if the Company elects to pay more than 50% of the interest rate in kind for any period, the Company will incur a step-up of 0.500% for such period, which shall be payable in cash. Further, the applicable interest rate will step down by 0.25% upon the Company’s achieving a gross leverage ratio of less than 4.0 to 1.0.

Each of the New Term Loans will be subject to an original issue discount of 1% of the principal amount thereof upon the drawing of each applicable tranche. Upon any payment or prepayment in full or in part of the New Term Loans, whether voluntary or involuntary, the Company is required to pay an exit fee equal to 1.0% of the principal amount of the New Term Loan paid, or the New Exit Fee.

The Company may elect to prepay all or any portion of the amounts owed prior to the Maturity Date, provided that the Company provides notice to the Administrative Agent, the amount is not less than $5,000,000, and the amount is accompanied by all accrued and unpaid interest thereon through the date of prepayment, plus the applicable yield protection premium and the applicable New Exit Fee.

Prepayments of the New Term Loans on or prior to the second anniversary of the funding date thereof will be accompanied by a yield protection premium equal to the present value of all interest that would have accrued on the principal amount prepaid through such date (discounted at the Treasury Rate plus 50 basis points), plus 2% of the principal amount so prepaid. Prepayments of the New Term Loans after the second anniversary of the funding date thereof but on or prior to the third anniversary of such date will be accompanied by a yield protection premium equal to 2% of the principal amount so prepaid. No yield protection premium will be required for prepayments of the New Term Loans made after the third anniversary of the funding date thereof.

Pursuant to the Amended Credit Agreement, the obligations of the Company are guaranteed by its subsidiaries that are party thereto as guarantors.

The Amended Credit Agreement contains customary affirmative and restrictive covenants and representations and warranties. The Company and its subsidiaries are bound by certain affirmative covenants setting forth actions that are required during the term of the Amended Credit Agreement, including, without limitation, certain information delivery requirements, obligations to maintain certain insurance, and certain notice requirements. Additionally, the Company and its subsidiaries are bound by certain restrictive covenants setting forth actions that are not permitted to be taken during the term of the Amended Credit Agreement without prior written consent, including, without limitation, incurring certain additional indebtedness, consummating certain mergers, acquisitions or other business combination transactions, or incurring any non-permitted lien or other encumbrance on the assets of the Company or any of its subsidiaries. The Amended Credit Agreement also contains other customary provisions, such as confidentiality obligations and indemnification rights for the benefit of lenders. The Amended Credit Agreement also contains financial covenants requiring (a) the Company to maintain minimum liquidity of at least $30,000,000 and (b) minimum gross sales of the Company and its subsidiaries for each consecutive 12-month period ending on the last day of each fiscal quarter in excess of an amount set forth in the Amended Credit Agreement for such period. The Amended Credit Agreement provides for a customary equity cure right in the event the Company fails to comply with the minimum gross sales covenant.

For lenders that continued as parties to the Amended Credit Agreement, the amendment was accounted for as a modification of the existing debt arrangement, and the existing unamortized debt issuance costs and debt discount related to these lenders continue to be amortized over the revised term of the facility along with new fees paid to such lenders. For new lenders replacing former lenders as parties to the Amended Credit Agreement, the amendment was accounted for as an extinguishment of the existing debt agreement resulting in the unamortized debt issuance costs and debt discount related to these lenders being written off and the new debt issuance costs and debt discount paid included in the balance of unamortized debt issuance costs and debt discount.

As of September 30, 2026, the effective interest rate under the Amended Credit Agreement was 9.7%. For the period following the Closing Date through September 30, 2026, the Company elected to pay interest in kind, or PIK, on 100% of the cash interest payment resulting in a step-up cash interest rate charge of 0.5%. The election is available quarterly through April 30, 2027. The Company incurred $6.5 million and $6.0 million in interest expense under the Amended Credit Agreement during the three months ended September 30, 2026 and 2025, respectively, and $19.7 million and $17.7 million in interest expense during the nine months ended September 30, 2026 and 2025, respectively. No principal payments are due on the New Term Loans until the final maturity date on April 30, 2031.

As of September 30, 2026, $277.7 million was outstanding under the Amended Credit Agreement representing the initial principal of $265.0 million for the Tranche E Term Loan, PIK of $9.9 million accrued into the principal balance, and the $2.7 million exit fee obligation to be paid upon exiting the facility. The exit obligation is also included in the net unamortized issuance costs and encompassed in the effective interest method.

The Company recorded the debt arrangements on the condensed consolidated balance sheets as follows:

As of September 30, 2026, the Company was in compliance with all financial debt covenants.

Inventory Funding Agreement

The Company signed an Inventory Funding Agreement, or Funding Agreement, on May 23, 2025, with RTW Master Fund, LTD., RTW Innovation Master Fund, LTD., and RTW Biotech Opportunities Operating LTD, collectively referred to as the Funding Providers, and RTW Investments, LP, as the funding representative, to finance purchases of silicone raw material to support the manufacture of Motiva Implants in an aggregate amount not to exceed $10.0 million in a funding period. Under the Funding Agreement, the Funding Providers will finance, upon request, eligible invoices at a 12.0% annual interest rate for an initial four-month term, or a later date if agreed by the Funding Providers in writing in their sole discretion. The Company drew $5.0 million at each of June 20, 2025 and September 26, 2025 and recorded this liability in “Other Liabilities, Short-Term”. On September 25, 2025, the Funding Agreement was amended to extend the due date for the amount received in June 2025 to May 15, 2026 and upon amending the Oak Tree Credit Agreement, the due date was further extended to January 15, 2027.

5. Net Loss Per Share

The following table summarizes the computation of basic and diluted net loss per share for the periods presented:

Basic net loss per share is computed by dividing the net loss by the weighted-average number of shares outstanding for the period. Diluted net loss per share is computed by dividing the net loss by the weighted-average number of shares and dilutive share equivalents outstanding for the period, determined using the treasury-share method and the as-if converted method, for convertible securities, if inclusion of these is dilutive.

If the Company reports a net loss, diluted net loss per share is the same as basic net loss per share for those periods because including the dilutive securities would be anti-dilutive.

The following potentially dilutive securities outstanding at the end of the periods presented have been excluded from the computation of diluted shares:

6. Related Party Transactions

During the nine months ended September 30, 2026 and 2025, the Company recorded revenue of $0.8 million and $1.1 million, respectively, for product sales to Herramientas Medicas, S.A., a distribution company owned by a family member of a former member of the Company’s Board of Directors and the Company’s former Chief Executive Officer, Juan José Chacón Quirós. Accounts receivable owed to the Company from this distribution company amounted to approximately $0.4 million as of both September 30, 2026 and December 31, 2025, respectively.

In June 2026, the Company entered into a Consulting and Royalty Agreement with Dr. Manuel Chacón Quirós, a family member of a former member of the Company’s Board of Directors and the Company’s former Chief Executive Officer, Juan José Chacón Quirós. Under the agreement, effective January 1, 2026, Dr. Chacón Quirós provides consulting, advisory, educational, and clinical support services and is entitled to receive royalty payments equal to 1% of annual net sales of qualifying Preservé products, subject to contractual terms and annual caps. The Company recorded expenses of $0.1 million for royalties to Dr. Chacón Quirós during the nine months ended September 30, 2026.

On April 24, 2026, the Company granted a stock option award to Mr. Lewin, Chairman of the Company’s Board of Directors, of 19,561 options with a grant date fair value of $0.7 million for consulting services.

7. Commitments and Contingencies

Contingencies

Periodically, the Company may have certain contingent liabilities that arise in the ordinary course of business activities. The Company accrues a liability for such matters when it is probable that future expenditures will be made and such expenditures can be reasonably estimated. As of September 30, 2026 and December 31, 2025, contingent liabilities were not material, individually or in the aggregate, to the Company’s financial condition, results of operations or cash flows. However, any monetary liability or financial impact to the Company from these contingent liabilities could differ materially from the Company’s expectations.

Patent Litigation

In 2025, the Company initiated patent enforcement actions relating to patents covering the surface architecture of its SmoothSilk silicone breast implants. The Company has asserted infringement claims against GC Aesthetics ParentCo Limited, et al., or the GCA Group, and Silimed Industria de Implantes LTDA, or Silimed, and is also defending challenges to the validity of the asserted patents. The matters involving the GCA Group are pending in Belgium and England, and the matters involving Silimed are pending in Brazil.

The Company believes its claims and defenses in these matters are meritorious, and it will continue to vigorously pursue them; however, the ultimate outcome of litigation is inherently uncertain. The Company's potential obligation in these matters is currently limited to possible reimbursement of a portion of the opposing parties' legal fees in jurisdictions where fee-shifting is customary. It is reasonably possible that an unfavorable outcome could result in such reimbursements. Given the current stages of these matters, the Company cannot reasonably estimate the potential range of legal fee exposure related to an unfavorable outcome.

Indemnification

The Company enters into standard indemnification arrangements in the ordinary course of business. Pursuant to these arrangements, the Company indemnifies, holds harmless, and agrees to reimburse the indemnified parties for losses suffered or incurred by the indemnified party in connection with any trade secret, copyright, patent or other intellectual property infringement claim by any third-party with respect to the Company’s technology. The term of these indemnification agreements is generally perpetual. The maximum potential amount of future payments the Company could be required to make under these agreements is not determinable because it involves claims that may be made against the Company in the future that have not yet been made.

The Company has entered into indemnification agreements with its directors and officers that may require the Company to indemnify its directors and officers against liabilities that may arise by reason of their status or service as directors or officers, other than liabilities arising from willful misconduct of the individual.

The Company has not incurred costs to defend lawsuits or settle claims related to these indemnification agreements. No liability associated with such indemnifications has been recorded to date.