ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

You should read the following discussion and analysis of our financial condition and results of operations together with the consolidated financial statements and related notes that are included elsewhere in this Annual Report on Form 10-K. This discussion contains forward-looking statements based upon current expectations that involve risks and uncertainties. Our actual results may differ materially from those anticipated in these forward-looking statements as a result of various factors, including those set forth under the sections contained in this Annual Report on Form 10-K entitled Item 1A. “Risk Factors”; Item 7. “Management’s Discussion and Analysis of Financial Condition and Results of Operations”; and Item 7A. “Quantitative and Qualitative Disclosures about Market Risk”. See “Special Note Regarding Forward-Looking Statements” preceding Part I of this Annual Report on Form 10-K.

Overview

Our line of silicone gel-filled breast implants, branded as Motiva Implants, is the centerpiece of our medical technology platform. Our 5-year results from our Motiva U.S. IDE study as well as our patient and practitioner reported post-market surveillance data indicate that Motiva Implants have low rates of adverse events (including rupture, capsular contracture, and implant-related reoperations) that compare favorably with those of our competitors. We believe these proprietary technologies that differentiate our Motiva Implants result in improved safety and aesthetic outcomes and thus drive our revenue growth.

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We have devoted a majority of our resources since inception to developing our Motiva Implants, which we began selling in October 2010. We have incurred net losses in each year since inception, and we have financed our operations primarily through equity financings and debt financings.

In September 2024, we received FDA approval to sell Motiva Implants in the United States.

Financial Highlights

Our revenue for the years ended December 31, 2025 and 2024 was $211.1 million and $166.0 million, respectively, an increase of $45.1 million, or 27.2%. Net losses were $51.1 million for the year ended December 31, 2025 as compared to $84.6 million for the year ended December 31, 2024. As of December 31, 2025, we had an accumulated deficit of $495.8 million.

Our cash balance as of December 31, 2025 was $75.6 million.

Recent Developments

Regulatory and Operational Updates

On October 14, 2025, we announced the publication of “The 3-Year Results of a 100-Patient Prospective Study of Safety and Effectiveness of Mia Femtech” in the Aesthetic Surgery Journal. The study showed a very low rate of complications, with no reports of capsular contracture (Baker Grade III/IV), implant rupture, nipple or breast sensitivity loss, incision-related complications, infection, seroma, rippling, hematoma, or BIA-ALCL; the reoperation rate at 3 years was 1%. Patient and surgeon satisfaction was high, with patients reporting an 87% increase in breast satisfaction at 3 years and 90% of surgeons “very satisfied” with their overall experience and none “dissatisfied”. See “Our Clinical Data—Mia Femtech Clinical Study” below for additional information.

On May 7, 2025, we announced the appointment of Peter Caldini as Chief Executive Officer following the retirement of Juan José Chacón-Quirós as CEO, effective March 1, 2025. Mr. Caldini served as Interim CEO from March 1, 2025 until May 7, 2025. Mr. Chacón-Quirós continued as a member of the Board and as an advisor with the Company.

On March 6, 2025, we partnered with GRAMMY winner Meghan Trainor, generating over 9 billion media impressions and supporting our U.S. market launch.

In February 2025, we launched Preservé, a minimally invasive breast tissue-preserving technology for breast augmentation, revision augmentation and mastopexy augmentation. The initial commercial launch took place in Brazil, with further launches in other countries occurring throughout 2025, including an early experience group in the United States. Launches in additional countries, including a full launch in the United States, are expected in 2026.

Financing Activities

We 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 million in a funding period. Under the Funding Agreement, the Funding Providers will finance, upon request, eligible invoices at a 12% 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. We drew $5 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.

On September 29, 2025, we entered into a Fourth Amendment to the Credit Agreement, or the Fourth Amendment, which provided for the availability of the Tranche D Term Loans to commence as of the effective date of the amendment, notwithstanding the revenue milestone originally set forth in the Agreement, and (ii) increased, effective September 28, 2025, the minimum liquidity that the Company and its subsidiaries that are guarantors under the Agreement are required to maintain from $25 million to $30 million. The fourth tranche, or the Tranche D Term Loan, of $25 million was advanced in September 2025.

During fiscal 2025, we also entered into short‐term insurance premium financing arrangements to fund the payment of business insurance premiums. The aggregate financing provided under these arrangements totaled approximately $3.4 million and bears interest at rates ranging from approximately 7.7% to 8.3% per annum. The borrowings are short‐term in nature and mature within ten months of issuance.

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Components of Results of Operations

Revenue

We commenced sales of our Motiva Implants in October 2010, and these products have historically accounted for the majority of our revenues. Sales of our Motiva breast implants accounted for over 99% of our revenues for the year ended December 31, 2025, and we expect our revenues to continue to be driven primarily by sales of these products. We primarily derive revenue from sales of our Motiva Implants to two types of customers: (1) medical distributors and (2) direct sales to physicians, hospitals, and clinics.

We recognize revenue related to the sales of products at the time of shipment, except for a portion of our sales revenue that is generated from the sale of consigned inventory maintained at physician, hospital, and clinic locations. For consignment sales, revenue is recognized at the time we are notified by the consignee that the product has been implanted. Our contracts with distributors do not typically contain right of return or price protection and have no post-delivery obligations.

We expect our revenue to fluctuate from quarter to quarter due to a variety of factors, including seasonal fluctuations in demand for Motiva Implants and foreign currency fluctuations.

Cost of Revenue and Gross Margin

Our implants are manufactured at our two facilities in Costa Rica. Cost of revenue is primarily the cost of silicone but also includes other raw materials, packaging, components, quality assurance, labor costs, as well as manufacturing and overhead expenses. Cost of revenue also includes depreciation expense for production equipment and amortization of certain intangible assets.

We calculate gross margin as revenue less cost of revenue for a given period divided by revenue. Our gross margin may fluctuate from period to period depending, in part, on the efficiency and utilization of our manufacturing facilities, fluctuations of foreign currency exchange rates, targeted pricing programs and sales volume based on geography, customer and product type.

Operating Expenses

Sales, General and Administrative

Sales, general and administrative, or SG&A, expenses primarily consist of compensation, including salary, share-based compensation and employee benefits for our sales and marketing personnel, and for administrative personnel that support our general operations such as information technology, executive management, financial accounting, customer service, and human resources personnel. SG&A expenses also includes costs attributable to freight, marketing, sales support, travel, legal services, financial audit fees, insurance costs, and consulting services.

We expect our SG&A expenses to remain significant in absolute dollars as our business grows and we continue to invest in our sales, marketing, medical education, training and general administration resources. We expect our SG&A expenses to decrease as a percentage of our revenue; however, our SG&A expenses may fluctuate from period to period due to the timing of expenses related to our sales and marketing campaigns, as well as expansion into new markets and geographies.

Research and Development

Our research and development, or R&D, activities primarily consist of engineering and research programs associated with our products under development, as well as R&D activities associated with our clinical development activities. Our R&D expenses primarily consist of compensation, including salary, share-based compensation and employee benefits for our R&D and clinical personnel. We also incur significant expenses for supplies, development prototypes, design and testing, clinical study costs and product regulatory and consulting expenses.

We received an approval of an IDE from the FDA in March 2018 to initiate a clinical trial and enrolled the first patient in April 2018. The IDE clinical trial is expected to cost between $30.0 million and $40.0 million over the duration of the clinical trial period of ten years. As of December 31, 2025, approximately $33.5 million has been spent on the trial to date. In addition, as part of the conditions of approval, a post-market study is required as well as continued follow-up of the IDE study subjects for the remainder of the initial ten-year study timeframe. The FDA

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is requiring this post-approval study, or PAS, to investigate the general post-market usage and endpoints not addressed during premarket evaluations. This study focuses on women undergoing primary breast augmentation and revision surgeries, along with a control group undergoing an aesthetic procedure other than breast implants. PAS is a decade-long study that will enroll 2,400 patients divided into three cohorts at up to 50 study sites in the United States. Patient participation for the study sites began in April 2025, with the first patients undergoing their surgeries in May 2025. We estimate we will incur between $4.0 million to $5.0 million in connection with the PAS over the next 10 years.

We expect our R&D expenses to remain elevated for the foreseeable future as we continue to advance our products under development, as well as initiate and prepare for additional clinical studies. We also have other products under development for which we may be required to conduct clinical trials in future periods in order to receive regulatory approval to market these products.

Interest Expense

Interest expense consists primarily of cash and non-cash interest related to outstanding debt and amortization of debt discounts. As of December 31, 2025, we had $246.4 million in outstanding principal under our term loan, including interest accrued into the principal balance. See Note 6 “Debt” for additional information.

Other Expense, Net

Other expense, net primarily consists of foreign currency gains/losses and interest income. As of December 31, 2024, it also included $6.0 million of contract termination costs related to cancellation of certain contracts in the fourth quarter of fiscal 2024. See Note 2 “Summary of Significant Accounting Policies” for additional information.

Income Tax Benefit

Income tax benefit primarily reflects income taxes incurred in the foreign jurisdictions in which we operate. In 2025, Motiva USA LLC, our U.S. subsidiary, released its valuation allowance on deferred tax assets, including net operating loss carryforwards, research and development tax credits, capitalized research and development costs, and other book‐to‐tax differences.

Business Update Regarding Macroeconomic Conditions

•2025 Results: As compared to the prior year, demand in fiscal 2025 improved in our EMEA markets, especially direct markets. As compared to fiscal 2024, we also saw an increase in demand in Latin America as demand in Brazil continues to stabilize and strong growth in Argentina continues. Our revenue in our Asia-Pacific market decreased as compared to the corresponding period of the prior year primarily due to our China distributor continuing to sell through inventory purchased in fiscal 2024 for the commercial launch. This performance in China is attributed to several factors, including lower consumer demand for aesthetic procedures. Management, in collaboration with our distribution partner, is dedicated to establishing Motiva as the leading implant in China, mirroring its success in other Asian markets. In the United States, we continue to see strong demand from the plastic surgeon community and positive feedback from plastic surgeons and patients alike. By December 31, 2025, we had successfully secured over 1,500 accounts across the United States, and Motiva Implants generated $45.6 million in sales within the United States for the year ended December 31, 2025.

•Outlook: Demand for our products is dependent on the relative strength of the global and regional medical device and aesthetic markets, which are sensitive to general macroeconomic conditions. The current global macroeconomic environment remains complex, with escalating trade tensions, uncertainty regarding tariffs, volatility in the capital markets, fluctuating exchange rates, declining consumer sentiment and elevated inflation and interest rates driving reductions in discretionary spending in the markets we operate. While several regions are currently showing good performance, as explained above, the outlook remains dynamic. Following the commercial launch of Motiva Implants in the United States in October 2024, we have been able to achieve higher selling prices for our Motiva Implants in the United States compared to other geographies. This dynamic has had a positive impact on our gross margins in 2025. Our commercial and operational activities increased following the FDA approval of Motiva Implants. As a

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result, we expect overall operating expenses to increase as compared to 2025, although we remain focused on managing operating expenses.

For additional information on the various risks and other uncertain macroeconomic conditions on our business, financial condition and results of operations, please see Part I, Item 1A. “Risk Factors” of this report.

Consolidated Results of Operations

The following table sets forth our results of operations for the years presented, in dollars:

Year Ended December 31,

(in thousands)

Operating expenses:

Benefit for income taxes 6,958 32

Comparison of the Year Ended December 31, 2025 and 2024

Year Ended December 31,

(in thousands)

Revenue

Revenue increased $45.1 million, or 27.2%, to $211.1 million for the year ended December 31, 2025, as compared to $166.0 million for the year ended December 31, 2024. The increase was primarily due to significantly higher sales in North America after FDA approval of Motiva Implants in September 2024, a 16.4% increase in revenue in the EMEA market and a 14.1% increase in revenue in Latin America partially offset by a 28.6% decrease in Asia-Pacific, due primarily to the timing of distributor purchases and sales.

Cost of Revenue and Gross Margin

Cost of revenue increased $8.3 million, or 14.7%, to $64.8 million for the year ended December 31, 2025, compared to $56.5 million for the year ended December 31, 2024. The increase in cost of revenue is in line with the increase in revenue.

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Gross margin increased to 69.3% for the year ended December 31, 2025, compared to 66.0% for the year ended December 31, 2024, primarily due to the favorable impact from sales within the United States due to higher selling prices in that region.

Operating Expenses

Year Ended December 31,

(in thousands)

Operating expenses:

Sales, General and Administrative Expense

SG&A expense increased $25.3 million, or 18.1%, to $165.1 million for the year ended December 31, 2025, compared to $139.8 million for the year ended December 31, 2024. The increase was primarily due to a $7.1 million increase in personnel and related costs, a $5.1 million increase in shipping & handling associated with higher sales, a $4.7 million increase in commissions, a $4.4 million increase in expense related to the fair value remeasurement of contingent consideration related the business acquisition of Motiva Benelux BV, a $2.3 million increase in depreciation and amortization expenses, a $1.5 million increase in bad debt expense, a $0.8 million increase in consulting fees, a $0.4 million increase in software implementation costs, and a $0.4 million increase in insurance expenses, partially offset by a $2.2 million decrease in sales and marketing expenses.

Research and Development Expense

R&D expense increased $0.5 million, or 2.5%, to $20.2 million for the year ended December 31, 2025, compared to $19.7 million for the year ended December 31, 2024. The increase in R&D expense was primarily due to a $1.6 million increase in personnel cost and a $0.2 million increase in regulatory affairs costs, partially offset by a $0.8 million decrease in stock compensation costs and a $0.5 million decrease in expenditures related to our IDE clinical trial in the United States.

Interest Expense

Interest expense increased $4.4 million, or 21.6%, to $25.3 million for the year ended December 31, 2025, as compared to $20.8 million for the year ended December 31, 2024. The increase was primarily due to an increase in debt principal.

Benefit for Income Taxes

Income tax benefit increased to $7.0 million for the year ended December 31, 2025 as compared to a tax benefit of $32.0 thousand for the year ended December 31, 2024. The increase in the tax benefit was primarily due to the release of the valuation allowance for one of our U.S. subsidiaries.

Other Income (Expense), Net

Other income (expense), net, decreased $20.0 million to an income of $6.2 million for the year ended December 31, 2025, compared to an expense of $13.8 million for the year ended December 31, 2024. The increase was primarily due to $6.0 million in contract termination costs incurred in the fourth quarter of fiscal 2024 and to the foreign currency fluctuations of the Brazilian real and the euro as compared to the U.S. dollar, resulting in a foreign currency transaction gain of $6.4 million, for the year ended December 31, 2025, compared to a loss of $8.8 million for the year ended December 31, 2024.

Interest income amounted to $0.4 million or the year ended December 31, 2025, as compared to $1.5 million for the year ended December 31, 2024.

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Comparison of the Year Ended December 31, 2024 and 2023

The discussion related to our results of operations and changes in financial condition for 2024 compared to 2023 is incorporated by reference to Part II, Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations in our Annual Report on Form 10-K for the year ended December 31, 2024, which was filed with the SEC on February 28, 2025.

Liquidity and Capital Resources

As of December 31, 2025, we had an accumulated deficit of $495.8 million. Since our inception, we have generated losses and expect to continue to generate losses in the near term. We have financed our operations through a combination of equity financings and debt financings, and from cash generated from operations, primarily from the collection of accounts receivable resulting from sales. Our historical cash outflows have primarily been associated with cash used for operating activities such as expansion of our sales and marketing and distributor infrastructure, investing in inventory, R&D activities, asset acquisitions, capital improvements, including our new manufacturing facility and other working capital needs. As of December 31, 2025 and 2024, we had cash of $75.6 million and $90.3 million, respectively.

As described above under “Recent Developments — Financing Activities,” in May, 2025, we entered into an Inventory Funding Agreement which allows us to finance purchases of up to $10.0 million of silicone raw material, in a given funding period, for an initial four-month term. Also, in September 2025, we entered into a Fourth Amendment to the Credit Agreement, or the Fourth Amendment, which provided for the availability of the Tranche D Term Loans to commence as of the effective date of the amendment, notwithstanding the revenue milestone originally set forth in the Agreement, and (ii) increased, effective September 28, 2025, the minimum liquidity that the Company and its subsidiaries are guarantors under the Agreement are required to maintain from $25 million to $30 million. The fourth tranche, or the Tranche D Term Loan, of $25 million was advanced in September 2025. See Note 6 “Debt” for additional information regarding the Credit Agreement.

Our short-term liquidity requirements consist primarily of operating expenses and interest payments on the Credit Agreement and other short-term borrowings described above. We believe that our available cash and cash from operations will be sufficient to satisfy our liquidity requirements for at least the next 12 months, including our contractual and other obligations summarized below under “Material Cash Requirements” section. Our long-term liquidity needs consist primarily of operating expenses, including expected increases in SG&A and R&D expenses related to our clinical trials, regulatory compliance and product development and funds necessary to pay for the interest and principal payment on our Term Loans (as defined below). Our liquidity assumptions may prove to be incorrect, and we could utilize our available financial resources sooner than we currently expect.

Our future capital requirements will depend on many factors, including:

•the degree and rate of market adoption of our products;

•the cost and timing of our regulatory activities;

•the emergence of new competing technologies and products;

•the costs of R&D activities we undertake to develop and expand our products;

•the costs of commercialization activities, including sales, marketing and manufacturing;

•the level of working capital required to support our growth; and

•our need for additional personnel, information technology or other operating infrastructure to support our growth and operations as a public company.

We may need to raise additional capital to execute our business plan. In April 2023, we filed an automatic shelf registration statement, or Shelf Registration Statement, with the SEC that expires in April 2026, which will allow us to offer and sell our common shares, warrants, rights and units. We may use the Shelf Registration Statement or other capital sources, including other offerings of equity or debt securities or the credit markets, to satisfy future financing needs. If we are unable to raise additional capital when desired, or on terms acceptable to us, our business, results of operations, and financial condition would be adversely affected.

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Cash Flows

The discussion related to our cash flows for 2024 is incorporated by reference to Part II, Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations in our Annual Report on Form 10-K for the year ended December 31, 2024, which was filed with the SEC on February 28, 2025.

The following table sets forth the primary sources and uses of cash for each of the years presented below:

Year Ended December 31,

(in thousands)

Net cash provided by (used in):

Effect of exchange rate changes on cash 2,709 (1,456)

Net (decrease) increase in cash $ (14,775) $ 50,312

Net Cash Used in Operating Activities

Net cash used in operating activities of $50.9 million for the year ended December 31, 2025 was primarily comprised of a net loss of $51.1 million, changes in operating assets and liabilities of $13.2 million, $10.0 million of unrealized foreign currency gain, and a $9.1 million change in provision for deferred income taxes, partially offset by $11.4 million of share-based compensation expense, $9.6 million of non-cash depreciation and amortization expense, a $3.4 million change in allowance for credit losses, $3.4 million of non-cash interest expense due to accretion of debt discounts, a $2.6 million change in provision for inventory obsolescence, $0.9 million of non-cash amortization expense of right-to-use assets, $0.5 million of non-cash loss on contract termination, $0.4 million of stock compensation in lieu of cash fees and a $0.2 million loss from disposal of property and equipment.

Net cash used in operating activities of $58.5 million for the year ended December 31, 2024 was primarily comprised of a net loss of $84.6 million, changes in operating assets and liabilities of $15.5 million, a $2.2 million change in provision for deferred income taxes and $0.6 million of interest capitalized for construction in progress, partially offset by $14.4 million of share-based compensation expense, $6.8 million of non-cash depreciation and amortization expense, $6.4 million of non-cash interest expense due to accretion of debt discounts, $6.0 million of non-cash loss on contract termination, $5.3 million of unrealized foreign currency loss, a $1.8 million change in provision for inventory obsolescence, a $1.7 million change in allowance for credit losses, $1.0 million of stock compensation in lieu of cash fees and $0.7 million of non-cash amortization expense of right-to-use assets.

Net Cash Used in Investing Activities

Net cash used in investing activities of $7.0 million for the year ended December 31, 2025 primarily consisted of $6.0 million in purchases of property and equipment related to the new manufacturing facility, $0.7 million in purchases of intangibles and $0.3 million in cash paid related to business acquisitions of Motiva Benelux BV and Motiva NL BV.

Net cash used in investing activities of $15.6 million for the year ended December 31, 2024 primarily consisted of $7.0 million in purchases of intangibles, $6.1 million in purchases of property and equipment related to the new manufacturing facility and $2.4 million of cash paid for capital expenditures on construction in progress related to our new manufacturing facility in the Coyol Free Zone in Costa Rica.

Net Cash Provided by Financing Activities

Net cash provided by financing activities of $40.4 million for the year ended December 31, 2025 primarily consisted of $24.5 million of borrowings under the Tranche D Term Loan of the Credit Agreement, $10.0 million in proceeds received from borrowings under short term notes payable, and $7.6 million in proceeds received for

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stock option exercises, partially offset by a $1.0 million repayment of short-term notes payable for insurance premium financing and $0.6 million paid to satisfy tax withholding obligations upon the vesting of restricted stock.

Net cash provided by financing activities of $125.9 million for the year ended December 31, 2024 primarily consisted of $99.5 million of proceeds received for the issuance of common shares, net of underwriters’ discount and issuance costs, from our public offering in April 2023, $24.5 million of borrowings under the Tranche C Term Loan of the Credit Agreement and $2.5 million in proceeds received for stock option exercises, partially offset by $0.5 million paid to satisfy tax withholding obligations upon the vesting of restricted stock.

Material Cash Requirements

The following table provides a summary of our material cash requirements from known contractual and other obligations, including commitments for capital expenditures, as of December 31, 2025:

(in thousands)

Debt obligations - principal (1) $ — $ 246,367 $ — $ — $ — $ — $ 246,367

Indebtedness

On April 26, 2022, or the Closing Date, we entered into the new Credit Agreement, pursuant to which the lenders agreed to make term loans in an aggregate principal amount of up to $225 million, which we collectively refer to as the Term Loans, with the first tranche of $150 million advanced on the Closing Date. Part of the first tranche was used to repay the outstanding principal and interest under our previous credit agreement with Madryn Health Partners, LP in full, including the early repayment penalty of $6.5 million. In December 2022, $25 million was advanced under the second tranche. In October 2024, $25 million was advanced under the third tranche. In September 2025, $25 million was advanced under the fourth tranche. The Term Loans will mature on the 5-year anniversary of the Closing Date and accrue interest at a rate equal to 9% per annum for the first two tranches and 10% for the third and fourth tranches. As of December 31, 2025, $246.4 million was outstanding under the Credit Agreement representing the initial principal of $150 million for the Tranche A Term Loan, $25 million for the Tranche B Term Loan, $25 million for the Tranche C Term Loan, $25 million for the Tranche D Term Loan and $21.4 million of interest accrued into the principal balance. See Note 6 “Debt” for additional information.

Critical Accounting Policies, Significant Judgments and Use of Estimates

This discussion and analysis of our financial condition and results of operations is based on our consolidated financial statements, which have been prepared in accordance with the generally accepted accounting principles in the United States of America, or GAAP. The preparation of these consolidated financial statements requires us to make estimates and judgments that affect the reported amounts of assets and liabilities, revenue and expenses, and the disclosure of contingent assets and liabilities. Our estimates are based on our historical experience and on various other assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities. Actual results may differ from these estimates. We believe that the critical accounting policies discussed below are essential to understanding our historical and future performance, as these policies relate to the more significant areas involving management’s estimates and judgments.

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Revenue Recognition

We recognize revenue related to sales of products to distributors or directly to customers in markets where it has regulatory approval, net of discounts and allowances. The Company recognizes revenue in accordance with Accounting Standards Codification, or ASC, 606, Revenue from Contracts with Customers. ASC 606 requires the Company to recognize revenue to depict the transfer of goods or services to a customer at an amount that reflects the consideration it expects to receive in exchange for those goods or services.

We recognize revenue related to the sales of products to distributors at the time of shipment of the product, which represents the point in time when the distributor has taken ownership and assumed the risk of loss and the required revenue recognition criteria are satisfied. Our distributors are obligated to pay within specified terms regardless of when, or if, they sell the products. Our contracts with distributors typically do not contain right of return or price protection and have no post-delivery obligations.

We recognize revenue when title to the product and risk of loss transfer to customers, provided there are no remaining performance obligations required of us or any written matters requiring customer acceptance. We allow for the return of product from direct customers in certain regions in limited instances within 15 to 60 days after the original sale and records estimated sales returns as a reduction of sales in the same period revenue is recognized. Appropriate reserves are established for anticipated sales returns based on historical experience, recent gross sales and any notification of pending returns. Actual sales returns in any future period are inherently uncertain and thus may differ from the estimates. If actual sales returns differ significantly from the estimates, an adjustment to revenue in the current or subsequent period is recorded. As of December 31, 2025 and 2024, an allowance of $1.9 million and $0.4 million was recorded for product returns, respectively. Taxes collected from customers for remittance to governmental authorities are excluded from net sales.

A portion of the our revenue is generated from the sale of consigned inventory maintained at physician, hospital, and clinic locations. For these products, revenue is recognized at the time we are notified by the consignee that the product has been implanted, not when the consigned products are delivered to the consignee’s warehouse.

We have a limited warranty for the shelf life of breast implants, which is five years from the time of manufacture. Estimated warranty obligations are recorded at the time of sale. We also offer a warranty to patients in the event of rupture and a replacement program for capsular contracture events, provided certain registration requirements are met. Revenue for extended warranties is recognized ratably over the term of the agreement. To date, these warranty and program costs have been de minimis. We will continue to evaluate the warranty reserve policies for adequacy considering claims history.

Deferred revenue primarily consists of payments received in advance of meeting revenue recognition criteria. We have received payments from distributors to provide distribution exclusivity within a geographic area and recognize deferred revenue on a ratable basis over the term of such contractual distribution relationship. Additionally, we have received payments from customers in direct markets prior to surgical implantation and recognize deferred revenue at the time we are notified by the customer that the product has been implanted. For all arrangements, any revenue that has been deferred and is expected to be recognized beyond one year is classified as long-term deferred revenue and included in “Other liabilities, long-term” on the consolidated balance sheets (see Note 3 “Balance Sheet Accounts”).

Research and Development

Costs related to research and development, or R&D, activities are expensed as incurred. R&D costs primarily include personnel costs, materials, clinical expenses, regulatory expenses, product development, consulting services, and outside research activities, all of which are directly related to R&D activities.

We estimate IDE clinical trial expenses based on the services performed, pursuant to contracts with research institutions and clinical research organizations that conduct and manage clinical trials on its behalf. In accruing service fees, we estimate the time period over which services will be performed and the level of patient enrollment and activity expended in each period. If the actual timing of the performance of services or the level of effort varies from the estimate, we will adjust the accrual accordingly.

Accounts Receivable and Allowance for Credit Losses

Accounts receivable is stated at invoice value less estimated allowances for returns and credit losses. We continually monitor customer payments and maintain an allowance for estimated losses resulting from customers’ inability to make required payments. In evaluating our ability to collect outstanding receivable balances, we

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consider various factors including the age of the balance, the creditworthiness of the customer, which is assessed based on ongoing credit evaluations and payment history, and the customer’s current financial condition. In cases where there are circumstances that may impair a specific customer’s ability to meet its financial obligations, an allowance is recorded against amounts due, which reduces the net recognized receivable to the amount reasonably believed to be collectible.

Inventory and Cost of Revenue

Inventory is stated at the lower of cost to purchase or manufacture the inventory or the net realizable value of such inventory. Cost is determined using the standard cost method which approximates actual costs using the first-in, first-out basis. We regularly reviews inventory quantities considering actual losses, projected future demand, and remaining shelf life to record a provision for excess and slow-moving inventory. Provision for inventory obsolescence of $3.9 million and $4.2 million has been recorded as of December 31, 2025 and 2024, respectively.

Long-Lived Assets

We review long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset might not be recoverable. When such an event occurs, management determines whether there has been impairment by comparing the anticipated undiscounted future net cash flows to the related asset group’s carrying value. If an asset is considered impaired, the asset is written down to fair value, which is determined based either on discounted cash flows or appraised value, depending on the nature of the asset. There were no impairment charges, or changes in estimated useful lives recorded during the years ended December 31, 2025 and 2024.

Income Taxes

We account for income taxes using the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences of differences between the financial reporting and tax bases of assets and liabilities, and for operating loss and tax credit carryforwards. Deferred tax balances are measured using enacted tax laws and rates expected to apply when the related temporary differences reverse. We establish a valuation allowance when it is more likely than not that some portion or all of a deferred tax asset will not be realized.

We operate in multiple tax jurisdictions and are subject to examination by various tax authorities. We recognize uncertain tax positions using a two‐step approach: (1) a tax position is recognized only if it is more likely than not to be sustained based on its technical merits, and (2) the amount recognized is the largest amount of benefit that is more than 50% likely to be realized upon settlement. Interest and penalties related to uncertain tax positions are recorded in income tax expense. There were no material uncertain tax positions as of December 31, 2025 and 2024.

Effective January 1, 2025, we adopted ASU 2023‐09, Improvements to Income Tax Disclosures, on a prospective basis. As a result, our income tax disclosures now include enhanced disaggregation of income taxes paid and a standardized effective tax rate reconciliation, as required by the amended guidance. The adoption did not affect our accounting for income taxes under ASC 740.

Foreign Currency

The financial statements of our foreign subsidiaries whose functional currencies are the local currencies are translated into U.S. dollars for consolidation as follows: assets and liabilities at the exchange rate as of the balance sheet date, shareholders’ equity at the historical rates of exchange, and income and expense amounts at the average exchange rate for the period. Translation adjustments resulting from the translation of the subsidiaries’ accounts are included in “Accumulated other comprehensive income” as equity in the consolidated balance sheet. Transactions denominated in currencies other than the applicable functional currency are converted to the functional currency at the exchange rate on the transaction date. At period end, monetary assets and liabilities are remeasured to the functional currency using exchange rates in effect at the balance sheet date. Non-monetary assets and liabilities are remeasured at historical exchange rates. Gains and losses resulting from foreign currency transactions are included within “Other income (expense), net” in the consolidated statement of operations. For the year ended December 31, 2025, foreign currency transaction gain amounted to $6.4 million as compared to a foreign currency transaction loss of $8.8 million for the year ended December 31, 2024.

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Share-Based Compensation

We measure and recognize compensation expense for all share-based awards in accordance with the provisions of ASC 718, Stock Compensation. Share-based awards granted include stock options, restricted stock units, or RSUs, and restricted stock awards, or RSAs. Share-based compensation expense for stock options and RSAs granted to employees is measured at the grant date based on the fair value of the awards and is recognized as an expense ratably on a straight-line basis over the requisite service period. The fair value of options to purchase shares granted to employees is estimated on the grant date using the Black-Scholes option valuation model.

The calculation of share-based compensation expense requires us to make assumptions and judgments about the variables used in the Black-Scholes model, including the expected term, expected volatility of the underlying common shares, risk-free interest rate and dividends.

See Note 10 “Share-Based Compensation” for additional information.

Recent Accounting Pronouncements

Please refer to Note 2 “Summary of Significant Accounting Policies” in the notes to the consolidated financial statements included in this Form 10-K for information on recent accounting pronouncements and the expected impact on our unaudited consolidated financial statements.

ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

Interest Rate Risk

We had cash of $75.6 million and $90.3 million as of December 31, 2025 and 2024, respectively. We manage our cash portfolio for operating and working capital purposes. Our cash balances are held in bank checking accounts, and we believe that we do not have any material exposure to changes in the fair value of our cash portfolio as a result of changes in interest rates.

Foreign Currency Exchange Risk

To date, the majority of our revenue has been denominated in U.S. dollars, Brazilian reals and euros. Some of our operating expenses are subject to fluctuations due to changes in foreign currency exchange rates, particularly changes in the euro and Brazilian real. Fluctuations in foreign currency exchange rates may cause us to recognize transaction gains and losses in our consolidated statements of operations. For the year ended December 31, 2025, foreign currency transaction gain amounted to $6.4 million primarily related to the remeasurement of transactions denominated in the U.S. dollar into the Brazilian real and the euro as part of the financial reporting consolidation process under GAAP. We have not engaged in any foreign currency hedging activities. As our international operations grow, we will continue to reassess our approach to managing the risks relating to fluctuations in foreign currency exchange rates. During the year ended December 31, 2025, the effect of an immediate 10% adverse change in foreign exchange rates on foreign-denominated accounts as of December 31, 2025 would have had an impact of approximately 1.8% on revenues and would have impacted our net loss by a commensurate amount.

Inflation Risk

We do not believe that inflation had a significant impact on our results of operations for any periods presented in our consolidated financial statements.

ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA

The financial statements required to be filed pursuant to this Item 8 are appended to this report beginning on page F‐1. An index of those financial statements is included in Part IV, Item 15 below.

ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE

None.

ITEM 9A. CONTROLS AND PROCEDURES

Evaluation of Disclosure Controls and Procedures

As of December 31, 2025, the end of the period covered by this Annual Report on Form 10-K, our management, with the participation of our Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our

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disclosure controls and procedures as of the end of the period covered by this Annual Report on Form 10-K. Disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended, or the Exchange Act) are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is (i) recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms and (ii) accumulated and communicated to the Company’s management, including its principal executive officer and principal financial officer, as appropriate to allow timely decisions regarding required disclosure. Based on the evaluation of our disclosure controls and procedures, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were effective as of the end of the period covered by this annual report at the reasonable assurance level.

Management’s Annual Report on Internal Control Over Financial Reporting

Our management is responsible for establishing and maintaining adequate internal control over financial reporting, as such term is defined in Rule 13a-15(f) of the Exchange Act. Our management has assessed the effectiveness of our internal control over financial reporting as of December 31, 2025 using the criteria established in “Internal Control—Integrated Framework” (2013), issued by the Committee of Sponsoring Organizations of the Treadway Commission, or COSO. Based on that assessment, our management has concluded that the Company’s internal control over financial reporting was effective as of December 31, 2025.

Changes in Internal Control over Financial Reporting

There has been no change in our internal control over financial reporting that occurred during the three months ended December 31, 2025 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

Limitations on Effectiveness of Controls and Procedures

Our disclosure controls and procedures and internal control over financial reporting are designed to provide reasonable assurance of achieving the desired control objectives. Our management recognizes that any control system, no matter how well designed and operated, is based upon certain judgments and assumptions and cannot provide absolute assurance that its objectives will be met. In addition, the design of disclosure controls and procedures must reflect the fact that there are resource constraints and that management is required to apply judgment in evaluating the benefits of possible controls and procedures relative to their costs. Similarly, an evaluation of controls cannot provide absolute assurance that misstatements due to error or fraud will not occur or that all control issues and instances of fraud, if any, have been detected.

Attestation Report of the Independent Registered Public Accounting Firm

The effectiveness of our internal control over financial reporting as of December 31, 2025 has been audited by CBIZ CPAs P.C., an independent registered public accounting firm, as stated in their report which is included below.

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Report of Independent Registered Public Accounting Firm on Internal Control Over Financial Reporting

To the Stockholders and Board of Directors of

Establishment Labs Holdings Inc.

Opinion on Internal Control over Financial Reporting

We have audited Establishment Labs Holdings Inc.'s (the “Company”) internal control over financial reporting as of December 31, 2025, based on criteria established in Internal Control-Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO) in 2013. In our opinion, the Companymaintained, in all material respects, effective internal control over financial reporting as of December 31, 2025, based on criteria established in COSO.

We have also audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (“PCAOB”), the consolidated balance sheet as of December 31, 2025 and the related consolidated statements of operations, comprehensive loss, shareholders’ equity, and cash flows and the related notes (collectively referred to as the “financial statements”) for the year ended December 31, 2025 of the Company, and our report dated February 27, 2026 expressed an unqualified opinion on those financial statements.

Basis for Opinion

The Company's management is responsible for maintaining effective internal control over financial reporting, and for its assessment of the effectiveness of internal control over financial reporting, included in the accompanying Management’s Annual Report on Internal Control over Financial Reporting. Our responsibility is to express an opinion on the Company's internal control over financial reporting based on our audit. We are a public accounting firm registered with the PCAOB and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

We conducted our audit in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether effective internal control over financial reporting was maintained in all material respects. Our audit of internal control over financial reporting included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, and testing and evaluating the design and operating effectiveness of internal control based on the assessed risk. Our audit also included performing such other procedures as we considered necessary in the circumstances. We believe that our audit provides a reasonable basis for our opinion.

Definition and Limitations of Internal Control over Financial Reporting

A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. A company's internal control over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally

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accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements.

Because of the inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that degree of compliance with the policies or procedures may deteriorate.

/s/ CBIZ CPAs P.C.

CBIZ CPAs P.C.

Los Angeles, California

February 27, 2026

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ITEM 9B. OTHER INFORMATION

Insider Trading Arrangements

On December 16, 2025, Juan José Chacón Quirós, former Chief Executive Officer and a current member of the Board of Directors, adopted a Rule 10b5-1 trading plan pursuant to which up to 330,000 common shares may be sold in accordance with the trading plan’s specifications. The first half of the shares subject to the plan will sell starting on March 23, 2026 and the remainder will sell starting April 23, 2026, if pre-established stock price thresholds are met. The trading plan will expire once all of the shares have been sold or on March 23, 2027, whichever is earlier. Actual sale transactions will be disclosed publicly through Form 4 filings with the Securities and Exchange Commission, as required.

Avantor Agreement

Effective May 2022, we entered into a master supply agreement with Avantor, Inc. (formerly NuSil Technology LLC), or Avantor, whereby Avantor provides us with NuSil brand medical-grade silicon for specified prices per unit of each relevant component. The material terms of this agreement were previously described in a Current Report on Form 8-K filed by the Company on June 6, 2022. As disclosed in such Current Report on Form 8-K, this master supply agreement has an initial term ending on December 31, 2026 and automatically renews for successive terms of one year each for up to five successive renewal terms, unless the Company or Avantor provides written notice no later than December 31 of the year prior to the expiration of the initial term or the then-current renewal term. On December 29, 2025, Avantor informed the Company that it does not intend to allow the agreement to renew automatically and plans to enter into negotiations regarding future supply terms. While we will negotiate with Avantor, we cannot guarantee whether we will reach an agreement on a timely basis or on favorable terms.

Executive Officer Transition

On February 24, 2026, we announced a strategic leadership transition of Raj Denhoy, current Chief Financial Officer, to Senior Vice President, Global Strategy, and the appointment of Cassandra “Sandra” Harris, 53, to Senior Vice President and Chief Financial Officer, effective March 9, 2026. Ms. Harris will also replace Mr. Denhoy as the Company’s principal accounting officer.

Ms. Harris brings extensive global finance and operational leadership experience, including prior service as Chief Financial Officer of Genesco Inc., a wholesale distributor and manufacturer, from 2024 to 2026, and Artisan Design Group, LLC, a national provider of interior finishes, from 2023 to 2024, as well as Chief Financial Officer and Chief Operating Officer of Tupperware Brands Corporation, a global consumer products company, from 2019 to 2022 and 2020 to 2022, respectively. Earlier in her career, she held senior finance and operational roles at VF Corporation, an apparel and footwear company, and began her career in audit at Deloitte & Touche LLP, a professional services firm. Ms. Harris is a Certified Public Accountant and holds a Bachelor of Science in Accounting from Clemson University. In connection with her appointment, Ms. Harris entered into an employment agreement that provides for, among other things, an annual base salary of $550,000, a target annual bonus opportunity of up to 50% of base salary, eligibility for annual equity awards, and a one‐time cash award of $700,000 payable in two installments. Ms. Harris has no family relationships with any director or executive officer of the Company, and there are no arrangements or understandings with any person pursuant to which she was selected as an officer of the Company. There are also no related person transactions between Ms. Harris and the Company that would be required to be disclosed pursuant to Item 404(a) of Regulation S-K under the Securities Exchange Act of 1934, as amended.

In his role as Senior Vice President, Global Strategy, Mr. Denhoy will be responsible for key strategic initiatives and long‐term growth priorities. This transition is not the result of any disagreement with the Company on any matter relating to its operations, policies, or practices.

ITEM 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS

Not applicable.

PART III

ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE

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Code of Business Conduct and Ethics

Our Board has adopted a Code of Business Conduct and Ethics that applies to all of our employees, officers and directors, including our chief executive officer, and other executive and senior financial officers. A copy of the code is posted under "Corporate Governance" in the Investors section of our website at https://establishmentlabs.com. If we make any substantive amendments to, or grant any waivers from, the Code of Business Conduct and Ethics for any officer or director, we will disclose the nature of such amendment or waiver on our website or in a current report on Form 8-K. None of the websites referenced in this Annual Report or the information contained therein is incorporated herein by reference.

The remaining information required by this Item is incorporated by reference from the information in our Proxy Statement for our 2026 Annual Meeting of Shareholders, which we will file with the SEC within 120 days of the end of the fiscal year to which this Annual Report on Form 10-K relates.

ITEM 11. EXECUTIVE COMPENSATION

The information required by this Item is incorporated by reference from the information in our Proxy Statement for our 2026 Annual Meeting of Shareholders, which we will file with the SEC within 120 days of the end of the fiscal year to which this Annual Report on Form 10-K relates.

ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS

ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE

ITEM 14. PRINCIPAL ACCOUNTING FEES AND SERVICES

PART IV

ITEM 15. EXHIBIT AND FINANCIAL STATEMENT SCHEDULES

The following statements are filed as part of this Annual Report on Form 10-K:

1. Financial Statements.

A listing of the Consolidated Financial Statements, related notes and Report of Independent Registered Public Accounting is set forth starting on page F-1 in this Annual Report on Form 10-K.

2. Financial Statement Schedules.

All schedules have been omitted since the required information is not present or is not present in amounts sufficient to require submission of a schedule, or because the information required is included in the financial statements or related notes.

3. Index to Exhibits.

Exhibit Number Description of Exhibit Incorporation by Reference

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Exhibit Number Description of Exhibit Incorporation by Reference

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Exhibit Number Description of Exhibit Incorporation by Reference

21.1 List of Subsidiaries of the Registrant. Filed herewith.

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Exhibit Number Description of Exhibit Incorporation by Reference

101.SCH XBRL Taxonomy Extension Schema Document

101.CAL XBRL Taxonomy Extension Calculation Linkbase Document

101.DEF XBRL Taxonomy Extension Definition Linkbase Document

101.LAB XBRL Taxonomy Extension Label Linkbase Document

101.PRE XBRL Taxonomy Extension Presentation Linkbase Document

+ Indicates management contract or compensatory plan or arrangement.

ITEM 16. FORM 10-K SUMMARY

None.

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PAGE

Report of Independent Registered Public Accounting Firm (PCAOB ID: 199) F-1

Report of Independent Registered Public Accounting Firm (PCAOB ID: 688) F-2

Consolidated Financial Statements

Consolidated Balance Sheets at December 31, 2025 and 2024 F-3

Notes to Consolidated Financial Statements F-9

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Report of Independent Registered Public Accounting Firm

To the Shareholders and Board of Directors of

Establishment Labs Holdings Inc.

Opinion on the Financial Statements

We have audited the accompanying consolidated balance sheet of Establishment Labs Holdings Inc.(the “Company”) as of December 31, 2025, the related consolidated statements of operations, comprehensive loss, stockholders’ equity and cash flows for the year ended December 31, 2025, and the related notes (collectively referred to as the “financial statements”).

In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2025, and the results of its operations and its cash flows for the year ended December 31, 2025, in conformity with accounting principles generally accepted in the United States of America.

We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) ("PCAOB"), the Company's internal control over financial reporting as of December 31, 2025,based on the criteria established in Internal Control – Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO) in 2013, and our report dated February 27, 2026, expressed an unqualified opinion on the effectiveness of the Company’s internal control over financial reporting.

Basis for Opinion

These financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on the Company's financial statements based on our audit.We are a public accounting firm registered with the PCAOB and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

We conducted our audit in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud.Our audit included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audit also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audit provides a reasonable basis for our opinion.

Critical Audit Matters

Critical audit matters are matters arising from the current period audit of the financial statements that were communicated or required to be communicated to the audit committee and that: (1) relate to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective, or complex judgments. We determined that there are no critical audit matters.

/s/ CBIZ CPAs P.C.

CBIZ CPAs P.C. (199)

We have served as the Company’s auditor since 2016 (such date takes into account the acquisition of the attest business of Marcum LLP by CBIZ CPAs P.C. effective November 1, 2024).

Los Angeles, California

February 27, 2026

F-1

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Report of Independent Registered Public Accounting Firm

To the Stockholders and Board of Directors of

Establishment Labs Holdings Inc.

Opinion on the Financial Statements

We have audited the accompanying consolidated balance sheet of Establishment Labs Holdings Inc. (the “Company”) as of as December 31, 2024, the related consolidated statements of operations, comprehensive loss, stockholders’ equity and cash flows for each of the two years in the period ended December 31, 2024, and the related notes (collectively referred to as the “financial statements”). In our opinion, based on our audits, the financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2024, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2024, in conformity with accounting principles generally accepted in the United States of America.

Basis for Opinion

These financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on the Company's financial statements based on our audits. We are a public accounting firm registered with the PCAOB and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audits to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.

/s/ Marcum LLP

MARCUM LLP (688)

We have served as the Company’s auditor since 2016 through 2025.

Los Angeles, California

February 28, 2025

F-2

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ESTABLISHMENT LABS HOLDINGS INC.

Consolidated Balance Sheets

(In thousands, except share data)

December 31,

Assets

Current assets:

Prepaid expenses and other current assets 11,260 8,922

Long-term assets:

Intangible assets, net of accumulated amortization 9,942 11,683

Right-of-use operating lease assets, net 4,339 5,561

Liabilities and shareholders’ equity

Current liabilities:

Long-term liabilities:

Note payable, Oaktree, net of debt discount and issuance costs 247,522 219,577

Operating lease liabilities, non-current 2,820 4,203

Commitments and contingencies (Note 16)

Shareholders’ equity:

Accumulated other comprehensive income 1,155 3,285

Total liabilities and shareholders’ equity $ 357,167 $ 346,831

The accompanying notes are an integral part of these consolidated financial statements.

F-3

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ESTABLISHMENT LABS HOLDINGS INC.

Consolidated Statements of Operations

(In thousands, except share and per share data)

Year Ended December 31,

Operating expenses:

Benefit (provision) for income taxes 6,958 32 81

Basic and diluted net loss per share $ (1.72) $ (3.00) $ (3.07)

The accompanying notes are an integral part of these consolidated financial statements.

F-4

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ESTABLISHMENT LABS HOLDINGS INC.

Consolidated Statements of Comprehensive Loss

(In thousands)

Year Ended December 31,

Other comprehensive income:

Foreign currency translation gain (loss) (2,130) 1,322 (752)

The accompanying notes are an integral part of these consolidated financial statements.

F-5

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ESTABLISHMENT LABS HOLDINGS INC.

Consolidated Statements of Shareholders’ Equity

(In thousands, except share data)

Shares Amount Shares Amount

Issuance of common shares in lieu of cash compensation 23,041 745 — — — — — 745

Foreign currency translation loss — — — — — — (752) (752)

Foreign currency translation gain — — — — — — 1,322 1,322

Foreign currency translation loss — — — — — — (2,130) (2,130)

The accompanying notes are an integral part of these consolidated financial statements.

F-6

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ESTABLISHMENT LABS HOLDINGS INC.

Consolidated Statements of Cash Flows

(In thousands)

Year Ended December 31,

Cash flows from operating activities:

Adjustments to reconcile net loss to net cash used in operating activities:

Change in reserve for PP&E impairment — — (341)

Loss from disposal of property and equipment 153 163 280

Unrealized foreign currency (gain)/loss, net (9,956) 5,302 (4,181)

Amortization of right-to-use asset 911 743 717

Non-cash loss on contract termination 543 6,004 —

Stock compensation in lieu of cash fees 403 964 495

Interest capitalized for construction in progress — (555) (3,567)

Non-cash interest expense and amortization of debt discount 3,445 6,371 13,278

Changes in operating assets and liabilities:

Prepaid expenses and other current assets 1,847 86 2,637

Cash flows from investing activities:

Cash used in business acquisitions, net of cash acquired (307) (50) —

Cost incurred for intangible assets (672) (7,033) (1,328)

Capital expenditures on construction in progress — (2,414) (15,311)

Cash flows from financing activities:

Borrowings on short term notes payable 10,000 — —

The accompanying notes are an integral part of these consolidated financial statements.

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ESTABLISHMENT LABS HOLDINGS INC.

Consolidated Statements of Cash Flows

(In thousands)

Year Ended December 31,

Effect of exchange rate changes on cash and cash equivalents 2,709 (1,456) 513

Net (decrease)/increase in cash and cash equivalents (14,775) 50,312 (26,320)

Supplemental disclosures:

Supplemental disclosures of non-cash investing and financing activities:

Unpaid balance for property and equipment $ 144 $ 240 $ 2,847

Unpaid balance for intangible assets $ 581 $ 592 $ 2,907

Equity consideration in an asset acquisition $ — $ — $ 250

Equity consideration issued in a business acquisition $ 3,556 $ 1,177 $ —

Consideration payable related to a business acquisition $ 315 $ 3,262 $ —

Cashless option exercises $ — $ — $ 4,500

Cashless warrant exercises $ — $ 600 $ —

Cash payable to settle contract termination $ — $ 214 $ —

Liability to issue shares to settle contract termination $ — $ 1,320 $ —

The accompanying notes are an integral part of these consolidated financial statements.

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ESTABLISHMENT LABS HOLDINGS, INC.

Notes to Consolidated Financial Statements

For the Years Ended December 31, 2025, 2024 and 2023

1. Formation and Business of the Company

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. As of December 31, 2025, the Company also has wholly-owned subsidiaries in the United States (JAMM Technologies, Inc. and Motiva USA LLC), Brazil (Establishment Labs Produtos para Saude Ltda), Belgium (European Distribution Center Motiva BV and Motiva Benelux BV), the Netherlands (Motiva NL BV), France (Motiva Implants France SAS), Sweden (Motiva Nordica AB), Switzerland (JEN-Vault AG), the United Kingdom (Motiva Implants UK Limited), Italy (Motiva Italy S.R.L), Spain (Motiva Implants Spain, S.L.), Austria (Motiva Austria GmbH), Germany (Motiva Germany GmbH) and Argentina (Motiva Argentina S.R.L). 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 distributors and direct 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 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.

F-9

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ESTABLISHMENT LABS HOLDINGS, INC.

Notes to Consolidated Financial Statements

For the Years Ended December 31, 2025, 2024 and 2023

The consolidated financial statements include the Company’s accounts and those of its wholly owned subsidiaries as of December 31, 2025 as follows:

Subsidiary Incorporation/Acquisition Date

Establishment Labs, S.A. (Costa Rica) January 18, 2004

Motiva USA, LLC (USA) February 20, 2014

JAMM Technologies, Inc. (USA) October 27, 2015

Establishment Labs Produtos par Saude Ltda (Brazil) January 4, 2016

European Distribution Center Motiva BV (Belgium) March 4, 2016

Motiva Implants France SAS (France) September 12, 2016

JEN-Vault AG (Switzerland) November 22, 2016

Motiva Nordica AB (Sweden) November 2, 2017

Motiva Implants UK Limited (the United Kingdom) July 31, 2018

Motiva Italy S.R.L (Italy) July 31, 2018

Motiva Implants Spain, S.L. (Spain) January 3, 2019

Motiva Austria GmbH (Austria) January 14, 2019

Motiva Germany GmbH (Germany) August 1, 2019

Motiva Argentina S.R.L. (Argentina) February 7, 2020

Motiva Benelux BV (Belgium) October 1, 2024

Motiva NL BV (Netherlands) October 1, 2024

All intercompany accounts and transactions have been eliminated in consolidation.

Segments

The chief operating decision maker, or CODM, for the Company is the Chief Executive Officer. The Chief Executive Officer reviews financial information presented on a consolidated basis, accompanied by information about revenue by geographic region, for purposes of allocating resources and evaluating financial performance. The Company has one business activity, and there are no segment managers who are held accountable for operations, operating results or plans for levels or components below the consolidated unit level. Accordingly, the Company has determined that it has one single reportable and operating segment structure. The Company and its Chief Executive Officer evaluate performance based primarily on revenue in the geographic regions in which the Company operates. See the consolidated statements of operations for the consolidated financial information and “Revenue Recognition” for revenue by geographic region used in evaluating financial performance. The level of disaggregation and amounts of significant segment expenses that are regularly provided to the CODM are the same as those presented in the consolidated statements of operations. Likewise, the measure of segment assets is reported on the consolidated balance sheets as total assets.

Geographic Concentrations

The Company derives substantially all of its revenues from sales to customers in the United States, Europe, the Middle East, Latin America, and Asia. The Company received approval to sell its Motiva Implants in the United States in September 2024 and Motiva Flora Tissue Expanded in October 2023. The revenue derived in the United States prior to the FDA approvals consisted of microtransponder sales.

For the year ended December 31, 2025, the United States accounted for 21.6% of consolidated revenue, and no other individual country exceeded 10% of consolidated revenue, on a ship-to-destination basis. For the year ended December 31, 2024, no individual country exceeded 10% of consolidated revenue, on a ship-to-destination basis. For the year ended December 31, 2023, Brazil accounted for 13.3%, respectively, of consolidated revenue

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ESTABLISHMENT LABS HOLDINGS, INC.

Notes to Consolidated Financial Statements

For the Years Ended December 31, 2025, 2024 and 2023

and no other individual country exceeded 10% of consolidated revenue, on a ship-to destination basis.

The majority of the Company’s consolidated total assets, including cash and tangible assets, is held in the United States. The Company’s long-lived assets, which primarily consist of property and equipment and intangible assets located in Costa Rica represented 73% and 78% of the total long-lived assets as of December 31, 2025 and 2024, respectively.

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 consolidated financial statements and accompanying notes. Significant accounting estimates and management judgments reflected in the consolidated financial statements include items such as accounts receivable valuation and allowances, inventory valuation and allowances, valuation of acquired intangible assets, valuation of long-lived assets, valuation of stock grants and valuation of deferred income tax assets, including tax valuation allowances. 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.

Concentration of Credit Risk and Other Risks and Uncertainties

Financial instruments that potentially subject the Company to a concentration of credit risk consist principally of cash and accounts receivable. The majority of the Company’s cash is held at two financial institutions in the United States. Balances in the Company’s cash accounts exceed the Federal Deposit Insurance Corporation, or FDIC, limit of $250,000. The Company has not experienced any losses to its deposits of cash.

Substantially all of the Company’s revenue has been derived from sales of its products in international markets, principally Europe, the Middle East, Latin America, and Asia. In the international markets in which the Company operates, the Company uses a combination of distributors and direct sales to customers. The Company performs ongoing credit evaluations of its distributors and customers, does not require collateral, and maintains allowances for potential credit losses on customer accounts when deemed necessary.

Substantially all of the Company’s revenues were derived from the sale of Motiva Implants. During the years ended December 31, 2025, 2024 and 2023, no customer accounted for more than 10% of the Company’s revenue. One customer accounted for 14.1% of the Company’s trade accounts receivable balance as of December 31, 2025. One customer accounted for 17.0% of the Company’s trade accounts receivable balance as of December 31, 2024.

The Company relies on Avantor, Inc. (formerly NuSil Technology, LLC), or Avantor, as the sole supplier of medical-grade silicone used in Motiva Implants. During the years ended December 31, 2025, 2024 and 2023, the Company had purchases of $31.6 million, or 55.8% of total purchases, $29.2 million, or 44.7% of total purchases, and $53.7 million, or 68.4% of total purchases, respectively, from Avantor. As of December 31, 2025 and 2024, the Company had an outstanding balance owed to this vendor of $8.9 million and $15.0 million, respectively.

The Company’s financial condition and future results of operations involve a number of risks and uncertainties. Factors that could affect the Company’s future operating results and cause actual results to vary materially from expectations include, but are not limited to, unfavorable economic conditions, uncertainty of continued or new regulatory approval for the Company’s current and potential future products, uncertainty of market acceptance of the Company’s products, competition from substitute products and larger companies, securing and protecting proprietary technology, access to capital, strategic relationships and dependence on key individuals and sole source suppliers.

Products developed by the Company require clearance from the FDA or other international regulatory agencies prior to commercial sales. There can be no assurance that the products will receive the necessary clearances. If the Company is denied clearance, clearance is delayed, or if the Company is unable to maintain its existing clearances, these developments could have a material adverse impact on the Company.

Cash and Cash Equivalents

The Company’s cash consists of cash maintained in checking and interest-bearing accounts. The majority of the Company’s cash is held at two financial institutions in the United States, with balances in excess of FDIC

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ESTABLISHMENT LABS HOLDINGS, INC.

Notes to Consolidated Financial Statements

For the Years Ended December 31, 2025, 2024 and 2023

insurance limits. The Company accounts for financial instruments with original maturities of three months or less at the date of purchase as cash equivalents. The Company held no cash equivalents as of December 31, 2025. The Company held $3.0 million cash equivalents as of December 31, 2024.

Accounts Receivable and Allowance for Credit Losses

Accounts receivable balance is stated at invoice value less estimated allowances for returns and credit losses. The Company continually monitors customer payments and maintains an allowance for estimated losses resulting from customers’ inability to make required payments. In evaluating the Company’s ability to collect outstanding receivable balances, the Company considers various factors including the age of the balance, the creditworthiness of the customer, which is assessed based on ongoing credit evaluations and payment history, and the customer’s current financial condition. In cases where there are circumstances that may impair a specific customer’s ability to meet its financial obligations, an allowance is recorded against amounts due, which reduces the net recognized receivable to the amount reasonably believed to be collectible.

A roll-forward of the allowance for credit losses is as follows:

Year Ended December 31,

(in thousands)

Inventory and Cost of Revenue

Inventory is stated at the lower of cost to purchase or manufacture the inventory or the net realizable value of such inventory. Cost is determined using the standard cost method which approximates actual costs using the first-in, first-out basis. The Company regularly reviews inventory quantities, actual losses, projected future demand, and remaining shelf life to record a provision for obsolete and/or damaged inventory.

A roll-forward of the inventory reserve is as follows:

Year Ended December 31,

(in thousands)

The Company recognizes the cost of inventory transferred to the customer in cost of revenue when revenue is recognized.

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ESTABLISHMENT LABS HOLDINGS, INC.

Notes to Consolidated Financial Statements

For the Years Ended December 31, 2025, 2024 and 2023

Leases

The Company determines if an arrangement is, or contains, a lease at the inception date of the contract. The Company has elected an expedient to account for each separate lease component and its associated non-lease components as a single lease component for the majority of its asset classes.

The lease term may include periods covered by options to extend or terminate the lease when it is reasonably certain that the Company will exercise a renewal option, or reasonably certain it will not exercise an early termination option. The Company recognizes lease liabilities and right-of-use, or ROU, assets upon commencement for all material leases with a term greater than 12 months. The Company has elected an expedient not to recognize leases with a lease term of 12 months or less on the balance sheet. These short-term leases are expensed on a straight-line basis over the lease term.

Shipping and Handling Costs

Shipping and handling costs are expensed as incurred and are included in selling, general and administrative, or SG&A, expenses. For the years ended December 31, 2025, 2024 and 2023, shipping and handling costs were $13.0 million, $7.2 million and $11.8 million, respectively.

Revenue Recognition

The Company recognizes revenue related to sales of products to distributors or directly to customers in markets where it has regulatory approval, net of discounts and allowances. The Company recognizes revenue in accordance with Accounting Standards Codification, or ASC, Revenue from Contracts with Customers (Topic 606). ASC 606 requires the Company to recognize revenue to depict the transfer of goods or services to a customer at an amount that reflects the consideration it expects to receive in exchange for those goods or services.

The Company recognizes revenue related to the sales of products to distributors at the time of shipment of the product, which represents the point in time when the distributor has taken ownership and assumed the risk of loss, and the required revenue recognition criteria are satisfied. The Company’s distributors are obligated to pay within specified terms regardless of when, or if, they sell the products. The Company’s contracts with distributors typically do not contain right of return or price protection and have no post-delivery obligations.

The Company recognizes revenue when title to the product and risk of loss transfer to customers, provided there are no remaining performance obligations required of the Company or any written matters requiring customer acceptance. The Company allows for the return of products from direct customers in certain regions in limited instances within 15 to 60 days after the original sale and records estimated sales returns as a reduction of sales in the same period revenue is recognized. Appropriate reserves are established for anticipated sales returns based on historical experience, recent gross sales and any notification of pending returns. Actual sales returns in any future period are inherently uncertain and thus may differ from the estimates. If actual sales returns differ significantly from the estimates, an adjustment to revenue in the current or subsequent period is recorded. As of December 31, 2025 and 2024, an allowance of $1.9 million and $0.4 million was recorded for product returns, respectively. Taxes collected from customers for remittance to governmental authorities are excluded from net sales.

A portion of the Company’s revenue is generated from the sale of consigned inventory maintained at physician, hospital, or clinic locations. For these products, revenue is recognized at the time the Company is notified by the consignee that the product has been implanted, not when the consigned products are delivered to the consignee’s warehouse.

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ESTABLISHMENT LABS HOLDINGS, INC.

Notes to Consolidated Financial Statements

For the Years Ended December 31, 2025, 2024 and 2023

Revenue was generated in these primary geographic markets:

Year Ended December 31,

(in thousands)

The Company has a limited warranty for the shelf life of breast implants, which is five years from the time of manufacture. Estimated warranty obligations are recorded at the time of sale. The Company also offers a warranty to patients in the event of rupture and a replacement program for capsular contracture events, provided certain registration requirements are met. Revenue for extended warranties is recognized ratably over the term of the agreement. To date, these warranty and program costs have been de minimis. The Company will continue to evaluate the warranty reserve policies for adequacy considering claims history.

Deferred revenue primarily consists of payments received in advance of meeting revenue recognition criteria. The Company has received payments from distributors to provide distribution exclusivity within a geographic area and recognizes revenue on a ratable basis over the term of such contractual distribution relationship. Additionally, the Company has received payments from customers in direct markets prior to surgical implantation and recognizes deferred revenue at the time the Company is notified by the customer that the product has been implanted. For all arrangements, any revenue that has been deferred and is expected to be recognized beyond one year is classified as long-term deferred revenue and included in “Other liabilities, long-term” on the consolidated balance sheets (see Note 3).

Research and Development

The Company estimates IDE clinical trial expenses based on the services performed, pursuant to contracts with research institutions and clinical research organizations that conduct and manage clinical trials on its behalf. In accruing service fees, the Company estimates the time period over which services will be performed and the level of patient enrollment and activity expended in each period. If the actual timing of the performance of services or the level of effort varies from the estimate, the Company will adjust the accrual accordingly.

Selling, General and Administrative Expenses

SG&A expenses include sales and marketing costs, payroll and related benefit costs, insurance expenses, shipping and handling costs, legal and professional fees and administrative overhead.

Property and Equipment

Property and equipment are stated at cost less accumulated depreciation and amortization.

The Company depreciates owned buildings on a straight-line basis over 50 years of useful life. Depreciation of property and equipment is computed using the straight-line method over the assets’ estimated useful lives of five to ten years. Leasehold improvements are amortized on a straight-line basis over the shorter of the estimated useful life of the asset or the remaining lease term after factoring expected renewal periods. Upon retirement or disposal of assets, the costs and related accumulated depreciation are eliminated from the accounts and any gain or loss is recognized in operations. Maintenance and repairs are expensed as incurred. Substantially all of the

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ESTABLISHMENT LABS HOLDINGS, INC.

Notes to Consolidated Financial Statements

For the Years Ended December 31, 2025, 2024 and 2023

Company’s manufacturing operations and related property and equipment are located in Costa Rica.

Goodwill and Intangible Assets

The Company records the excess of the acquisition purchase price over the net fair value of the tangible and identifiable intangible assets acquired and liabilities assumed as goodwill. In accordance with ASC 350, Intangibles - Goodwill and Other, the Company tests goodwill for impairment annually during the fourth quarter of each year and whenever events or changes in circumstances indicate that the carrying value of the asset may not be recoverable. In connection with the annual impairment test for goodwill, the Company elected the option to perform a qualitative assessment to determine whether it is more likely than not that the fair value of the reporting unit is less than its carrying amount. If the Company determines that it was more likely than not that the fair value of the reporting unit is less than its carrying amount, then the impairment test is performed.

Consistent with the Company’s assessment that it has only one reporting segment, the Company has determined that it has only one reporting unit and tests goodwill for impairment at the entity level using the two-step process required by ASC 350. In the first step, the Company compares the carrying amount of the reporting unit to the fair value of the enterprise. If the fair value of the enterprise exceeds the carrying value, goodwill is not considered impaired and no further testing is required. If the carrying value of the enterprise exceeds the fair value, goodwill is potentially impaired, and the second step of the impairment test must be performed. In the second step, the Company compares the implied fair value of the goodwill, as defined by ASC 350, to its carrying amount to determine the impairment loss, if any.

The Company capitalizes certain costs related to intangible assets, such as patents, trademarks and software development costs. The Company follows the provisions of ASC 350-40, Internal Use Software for determining whether computer software is internal-use software and on accounting for the costs of computer software originally developed or obtained for internal use. The Company expenses all costs incurred during the preliminary project stage of software development and capitalizes the costs incurred during the application development stage. Costs incurred relating to upgrades and enhancements to the software are capitalized if it is determined that these upgrades or enhancements add additional functionality to the software. Costs incurred to improve and support products after they become available are charged to expense as incurred.

The Company records purchased intangible assets at their respective estimated fair values at the date of acquisition. Purchased finite-lived intangible assets are being amortized using the straight-line method over their remaining estimated useful lives, which range from one to ten years. The Company evaluates the remaining useful lives of intangible assets on a periodic basis to determine whether events or circumstances warrant a revision to the remaining estimated amortization period. The Company tests indefinite-lived intangible assets for impairment on at least an annual basis and whenever circumstances suggest the assets may be impaired. If indicators of impairment are present, the Company evaluates the carrying value of the intangible assets in relation to estimates of future undiscounted cash flows. The Company also evaluates the remaining useful life of an indefinite-lived intangible asset to determine whether events and circumstances continue to support an indefinite useful life.

During the years ended December 31, 2025, 2024 and 2023, there has been no impairment of goodwill or intangible assets based on the qualitative assessments performed by the Company.

Long-Lived Assets

The Company reviews long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset might not be recoverable. When such an event occurs, management determines whether there has been impairment by comparing the anticipated undiscounted future net cash flows to the related asset group’s carrying value. If an asset is considered impaired, the asset is written down to fair value, which is determined based either on discounted cash flows or appraised value, depending on the nature of the asset. There were no impairment charges, or changes in estimated useful lives recorded during the years ended December 31, 2025, 2024 and 2023.

Debt Issuance Costs and Debt Discounts

Costs incurred in connection with the issuance of new debt are capitalized. Capitalizable debt issuance costs paid to third parties and debt discounts, net of amortization, are recorded as a reduction to the long-term debt balance

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ESTABLISHMENT LABS HOLDINGS, INC.

Notes to Consolidated Financial Statements

For the Years Ended December 31, 2025, 2024 and 2023

on the consolidated balance sheets. Amortization expense on capitalized debt issuance costs and debt discounts related to loans are calculated using the effective interest method over the term of the loan commitment and is recorded as interest expense in the consolidated statements of operations.

Income Taxes

The Company accounts for income taxes using the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences of differences between the financial reporting and tax bases of assets and liabilities, and for operating loss and tax credit carryforwards. Deferred tax balances are measured using enacted tax laws and rates expected to apply when the related temporary differences reverse. The Company establishes a valuation allowance when it is more likely than not that some portion or all of a deferred tax asset will not be realized.

The Company operates in multiple tax jurisdictions and is subject to examination by various tax authorities. The Company recognizes uncertain tax positions using a two‐step approach: (1) a tax position is recognized only if it is more likely than not to be sustained based on its technical merits, and (2) the amount recognized is the largest amount of benefit that is more than 50% likely to be realized upon settlement. Interest and penalties related to uncertain tax positions are recorded in income tax expense. There were no material uncertain tax positions in the years ended December 31, 2025, 2024 and 2023.

Effective January 1, 2025, the Company adopted ASU 2023‐09, Improvements to Income Tax Disclosures, on a prospective basis. As a result, our income tax disclosures now include enhanced disaggregation of income taxes paid and a standardized effective tax rate reconciliation, as required by the amended guidance. The adoption did not affect our accounting for income taxes under ASC 740.

Foreign Currency

The financial statements of the Company’s foreign subsidiaries whose functional currencies are the local currencies are translated into U.S. dollars for consolidation as follows: assets and liabilities at the exchange rate as of the balance sheet date, shareholders’ equity at the historical rates of exchange, and income and expense amounts at the average exchange rate for the period. Translation adjustments resulting from the translation of the subsidiaries’ accounts are included in “Accumulated other comprehensive income” as equity in the consolidated balance sheet. Transactions denominated in currencies other than the applicable functional currency are converted to the functional currency at the exchange rate on the transaction date. At period end, monetary assets and liabilities are remeasured to the functional currency using exchange rates in effect at the balance sheet date. Non-monetary assets and liabilities are remeasured at historical exchange rates. Gains and losses resulting from foreign currency transactions are included within “Other income (expense), net” in the consolidated statement of operations. For the years ended December 31, 2025, 2024 and 2023, foreign currency transaction gain/loss amounted to a gain of $6.4 million, a loss of $8.8 million and a gain of $1.8 million, respectively.

Contract Termination Costs

From time to time the Company may settle certain contracts with third parties. In the second quarter of 2025, the Company terminated a contract with a supplier of raw materials and recorded a $0.5 million loss on contract termination. In the fourth quarter of 2024, the Company entered into a contract termination agreement with a third-party in connection with its Mia products in Europe. In lieu of a cash settlement, the Company and the third-party agreed to settle previous amounts incurred by each respective party from separate and unrelated contracts. As of December 31, 2024, the Company recorded a $1.5 million liability for contract termination payments resulting in a total loss on contract termination of $6.0 million reported under “Other income (expense), net”. There were no such costs in the years ended December 31, 2023.

Comprehensive Loss

The Company’s comprehensive loss consists of net loss and foreign currency translation adjustments arising from the consolidation of the Company’s foreign subsidiaries.

Share-Based Compensation

The Company measures and recognizes compensation expense for all share-based awards in accordance with the provisions of ASC 718, Stock Compensation. Share-based awards granted include stock options, restricted stock units, or RSUs, and restricted stock awards, or RSAs. Share-based compensation expense for stock

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ESTABLISHMENT LABS HOLDINGS, INC.

Notes to Consolidated Financial Statements

For the Years Ended December 31, 2025, 2024 and 2023

options, RSUs and RSAs granted to employees is measured at the grant date based on the fair value of the awards and is recognized as an expense ratably on a straight-line basis over the requisite service period. The fair value of options to purchase shares is estimated on the grant date using the Black-Scholes option valuation model.

The calculation of share-based compensation expense requires the Company to make assumptions and judgments about the variables used in the Black-Scholes model, including the expected term, expected volatility of the underlying common shares, risk-free interest rate and dividends.

Net Income (Loss) Per Share

Basic net income (loss) per share is calculated by dividing the net income (loss) attributable to shareholders by the weighted-average number of shares outstanding during the period, without consideration for potentially dilutive securities. Diluted net income (loss) per share is computed by dividing the net income (loss) by the weighted-average number of shares and potentially dilutive securities outstanding for the period. For purposes of the diluted net loss per share calculation, any shares issuable upon exercise of warrants, stock options and non-vested RSUs or RSAs outstanding under the Company’s equity plan are potentially dilutive securities. Diluted net loss per share is the same as basic net loss per share for periods where the Company reported a net loss because including the dilutive securities would be anti-dilutive.

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 will not have a material impact on the Company’s consolidated financial statements upon adoption.

Recently Adopted Accounting Standards

In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topics 740): Improvements to Income Tax Disclosures, which enhances the disclosure requirements for income taxes, specifically related to the rate reconciliation and income taxes paid and certain other amendments to improve the effectiveness of income tax disclosures. The guidance is effective for annual periods beginning after December 15, 2024, with early adoption permitted, and may be applied either prospectively or retrospectively. The Company adopted ASU 2023-09 as of December 31, 2025 on a prospective basis. Upon adoption, the Company expanded disclosures under Note 12, “Income Taxes”.

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.

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ESTABLISHMENT LABS HOLDINGS, INC.

Notes to Consolidated Financial Statements

For the Years Ended December 31, 2025, 2024 and 2023

3. Balance Sheet Accounts

Inventory, Net

December 31,

(in thousands)

As of December 31, 2025 and 2024, $14.1 million and $9.0 million of inventory was on consignment, respectively.

Prepaid Expenses and Other Current Assets

December 31,

(in thousands)

Prepaid raw materials and accessories 384 1,005

Prepaid U.S. clinical trial costs 120 184

Prepaid warranty and distribution rights 379 409

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ESTABLISHMENT LABS HOLDINGS, INC.

Notes to Consolidated Financial Statements

For the Years Ended December 31, 2025, 2024 and 2023

Property and Equipment, Net

December 31,

(in thousands)

Less: Accumulated depreciation and amortization (26,213) (20,116)

Total property and equipment, net $ 75,615 $ 78,028

For the years ended December 31, 2025, 2024 and 2023, depreciation and amortization expense related to property and equipment was $6.2 million,$4.7 million and $2.8 million, respectively.

In August 2021, the Company entered into a contract with the Zona Franca Coyol, S.A., or ZFC, to begin construction of a new manufacturing facility in the Coyol Free Zone, or the CFZ, in Costa Rica. The construction for this facility was completed in June 2024. The Company also has the option to buy an adjacent lot of land for approximately $2.8 million and engage ZFC to construct an additional manufacturing facility.

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ESTABLISHMENT LABS HOLDINGS, INC.

Notes to Consolidated Financial Statements

For the Years Ended December 31, 2025, 2024 and 2023

Accrued Liabilities

Accrued liabilities consisted of the following:

December 31,

ESTA US Equity

ESTA · 10-K · period ended 2025-12-31

ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA

ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE

ITEM 9A. CONTROLS AND PROCEDURES

ITEM 9B. OTHER INFORMATION

ITEM 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS

ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE

ITEM 11. EXECUTIVE COMPENSATION

ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS

ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE

ITEM 14. PRINCIPAL ACCOUNTING FEES AND SERVICES

ITEM 15. EXHIBIT AND FINANCIAL STATEMENT SCHEDULES

ITEM 16. FORM 10-K SUMMARY

ESTA US Equity☆

ESTA · 10-K · period ended 2025-12-31

ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA

ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE

ITEM 9A. CONTROLS AND PROCEDURES

ITEM 9B. OTHER INFORMATION

ITEM 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS

ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE

ITEM 11. EXECUTIVE COMPENSATION

ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS

ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE

ITEM 14. PRINCIPAL ACCOUNTING FEES AND SERVICES

ITEM 15. EXHIBIT AND FINANCIAL STATEMENT SCHEDULES

ITEM 16. FORM 10-K SUMMARY

ESTA US Equity