ESTABLISHMENT LABS HOLDINGS INC.
For the period ended Dec 31, 2025. Filed Feb 27, 2026.
View on SEC.govAbout this filing
A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.
FY2025 · Filed Feb 27, 2026
ESTA$67.02+4.0%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-K
Period ended 2024-12-31; filed 2025-02-28.
0001688757-25-000019
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-K
Period ended 2025-12-31; filed 2026-02-27.
0001688757-26-000022
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 127 previous paragraphs and 123 current paragraphs.
74 unchanged; 35 reworded; 13 added; 15 removed; 3 previous and 1 current paragraphs rearranged.
Tables are not compared: 5 previous and 5 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (13)
Current report
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.
Current report
On March 6, 2025, we partnered with GRAMMY winner Meghan Trainor, generating over 9 billion media impressions and supporting our U.S. market launch.
Current report
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.
Current report
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.
Current report
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.
Current report
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 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.
Current report
Income Tax Benefit
Current report
•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.
Current report
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.
Current report
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.
Current report
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.
Current report
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.
Current report
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.
Removed paragraphs (15)
Previous report
In October 2024, we completed and announced the results of the three-year 100-patient clinical study for Mia Femtech, our patented technology that can increase breast shape by 1 to 2 cups in a 15-minute procedure without the need for general anesthesia. The single-center, Institutional Review Board approved study began in December 2020 and involved the participation of fifteen board-certified plastic surgeons in multiple geographies. We currently offer Mia Femtech in multiple countries across the world with plastic surgeons fully certified to provide the Mia experience.
Previous report
In September 2024, we received PMA approval from the FDA for our Motiva Implants. Beginning in October 2024, we began selling Motiva Implants for use in breast augmentation for patients in the United States.
Previous report
In June 2024, we finalized the construction of our manufacturing and corporate offices in the Coyol Free Zone, or CFZ, in Costa Rica, which includes approximately 100,000 square feet of facility space intended to increase our manufacturing capacity by approximately 730,000 units per year. The facility has obtained necessary regulatory approvals to commence manufacturing. We incurred approximately $56.0 million in costs for this phase of the project over the time frame of 2020 to 2024. Additional phases of the project may be executed, at our option, to further expand manufacturing capacity at the new facility.
Previous report
In January 2024, we announced the commercial launch of Motiva Implants in China and the completion of the first procedure with the Motiva Flora SmoothSilk Tissue Expander in the United States. These events followed our receipt of National Medical Products Administration, or NMPA, approval in China for Motiva Implants and our 510(k) clearance from the FDA for the Motiva Flora SmoothSilk Tissue Expander in the United States, both in November 2023.
Previous report
On November 7, 2024, we entered into a securities purchase agreement with a limited number of purchasers in connection with a registered direct offering of 765,696 common shares and pre-funded warrants to purchase up to 328,154 common shares. We also agreed to issue up to 76,569 additional common shares and additional pre-funded warrants to purchase up to 32,814 common shares for no additional consideration if the average closing price of our common shares on The Nasdaq Capital Market, or Nasdaq, during the period from January 1, 2025 to August 31, 2025 does not exceed the $45.71 price per common share sold in the offering. Our net proceeds from the offering, after deducting offering expenses, were approximately $49.7 million. See Note 8 “Shareholders’ Equity” for additional information.
Previous report
Also on November 7, 2024, we entered into a Third Amendment to the Credit Agreement and Guaranty, dated April 26, 2022, or the Credit Agreement, that we entered into together with certain of our subsidiaries party thereto as guarantors, the lenders from time to time party thereto, or the Lenders, and Oaktree Fund Administration, LLC, as administrative agent for the Lenders, or the Administrative Agent. The Third Amendment extended the commitment termination date, with respect to the commitments applicable to the Tranche D Term Loans, from June 30, 2025 to December 31, 2025, and modified the milestones triggering the availability of the Tranche D Term Loans. The terms of the Tranche A Term Loans, Tranche B and Tranche C Term Loans were not modified. See Note 6 “Debt” for additional information.
Previous report
In February 2024, we entered into a Second Amendment to the Credit Agreement, which provides for term loans in an aggregate principal amount of up to $225 million. The Second Amendment modified the access conditions, commitment termination dates and interest rates for the two remaining available tranches, Tranche C Term Loans and Tranche D Term Loans. See Note 6 “Debt” for additional information. The Tranche C Term Loan of $25 million was advanced in October 2024 at the Company’s election following the administrative agent’s receipt of evidence that the FDA’s approval of Motiva Implants for augmentation use in the United States had been issued, subject to the other terms and conditions of the Credit Agreement, as amended.
Previous report
In January 2024, we entered into a securities purchase agreement with select institutional accredited investors pursuant to which we agreed to sell to the investors in a private placement 1,101,565 common shares and pre-funded warrants to purchase up to 898,435 common shares. The pre-funded warrants are exercisable immediately, at a price of $0.001 per share, until exercised in full. Net proceeds to us from the offering, after deducting offering expenses, were approximately $49.7 million. See Note 8 “Shareholders’ Equity” for additional information.
Previous report
Income Tax Expense
Previous report
•2024 Results: Demand in fiscal 2024 improved in our Asian markets while Latin America, Brazil in particular, continues to suffer from weaker underlying demand for aesthetic and reconstructive plastic surgery compared to fiscal 2023. In September 2024, we received FDA approval to sell Motiva Implants in the United States and have seen strong demand from the plastic surgeon community and positive feedback. We were able to achieve higher selling prices in the United States which had a positive impact on gross margins the fourth quarter of 2024.
Previous report
Revenue increased $0.8 million, or 0.5%, to $166.0 million for the year ended December 31, 2024, as compared to $165.2 million for the year ended December 31, 2023. The increase was primarily due to a 43% revenue increase in the Asia Pacific region and higher revenue in North America after FDA approval of Motiva Implants in September 2024, partially offset by a 28% revenue decrease in Latin America compared to the same period in fiscal 2023. Revenue from our EMEA market remained relatively stable.
Previous report
Benefit for income taxes for the year ended December 31, 2024 of $32.0 thousand stayed comparable to the tax benefit of $81.0 thousand for the year ended December 31, 2023.
Previous report
As described above under “Recent Developments - Financing Activities,” in February 2024 and November 2024, we entered into amendments to the Credit Agreement, which, among other changes, extended the termination date for commitments for Tranche C and Tranche D Term Loans and modified the milestones triggering the availability of those loans. The Tranche C Term Loan of $25 million was advanced in October 2024. See Note 6 “Debt” for additional information regarding the Credit Agreement.
Previous report
During 2024, we also engaged in capital markets financing activities. These included a registered direct offering of common shares and pre-funded warrants to purchase common shares that we completed in November 2024 resulting in net proceeds to us, after deducting offering expenses, of approximately $49.7 million, and a private offering of our common shares and pre-funded warrants to purchase our common shares that we completed in January 2024 resulting in net proceeds to us, after deducting offering expenses, of approximately $49.7 million. In 2023, we completed an underwritten public offering of common shares, resulting in net proceeds to us after deducting underwriting discounts and offering expenses of approximately $84.6 million. See Note 8 “Shareholders’ Equity” for additional information.
Previous report
We record income taxes using the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been recognized in our consolidated financial statements or income tax returns. In estimating future tax consequences, expected future events, enactments or changes in the tax law or rates are considered. Valuation allowances are provided when necessary to reduce deferred tax assets to the amount expected to be realized.
Reworded paragraphs (35)
Previous wording
Our line of silicone gel-filled breast implants, branded as Motiva Implants, is the centerpiece of our medical technology platform. Our post-market surveillance data (which was not generated in connection with a United States Food and Drug Administration, or FDA, pre-market approval, or PMA, study collected at defined follow-ups, but was patient or practitioner reported) and published third-party registries and data indicate that Motiva Implants have low rates of adverse events (including rupture, capsular contracture, and safety related reoperations) that we believe compare favorably with those of our competitors. We believe the proprietary technologies that differentiate our Motiva Implants enable improved safety and aesthetic outcomes and drive our revenue growth. We have developed other complementary products and services, which are aimed at further enhancing patient outcomes.
Current wording
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.
Previous wording
Our revenue for the years ended December 31, 2024 and 2023 was $166.0 million and $165.2 million, respectively, an increase of $0.8 million, or 0.5%. Net losses were $84.6 million for the year ended December 31, 2024 as compared to $78.5 million for the year ended December 31, 2023. As of December 31, 2024, we had an accumulated deficit of $444.7 million.
Current wording
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.
Previous wording
Our cash balance as of December 31, 2024 was $90.3 million.
Current wording
Our cash balance as of December 31, 2025 was $75.6 million.
Previous wording
In January 2025, we announced the retirement of Juan José Chacón-Quirós as CEO, effective March 1, 2025. Peter Caldini, our current President, will serve as Interim CEO effective the same day. Following his departure as Chief Executive Officer, Mr. Chacón-Quirós will continue as a member of the Board and as an advisor with the Company.
Current wording
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.
Previous wording
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 additional launches planned in other countries throughout 2025.
Current wording
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.
Previous wording
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 96% of our revenues for the year ended December 31, 2024, 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.
Current wording
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.
Previous wording
We recognize revenue related to the sales of products at the time of shipment, except for a portion of our direct 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.
Current wording
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.
Previous wording
Our implants are manufactured at our facilities in Costa Rica. Construction of our third facility in Costa Rica was completed in June 2024. Subsequently, the smallest manufacturing facility ceased production in August 2024. 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.
Current wording
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.
Previous wording
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 to build our corporate infrastructure. However, we expect our SG&A expenses to decrease as a percentage of our revenue over the long term, although 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.
Current wording
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.
Previous wording
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 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, 2024, approximately $32.2 million has been spent on the trial to date. 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.
Current wording
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.
Previous wording
Interest expense consists primarily of cash and non-cash interest related to outstanding debt and amortization of debt discounts. As of December 31, 2024, we had $221.4 million in outstanding principal under our term loan, including interest accrued into the principal balance. See Note 6 “Debt” for additional information.
Current wording
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.
Previous wording
Income tax expense consists primarily of income taxes in foreign jurisdictions in which we conduct business. Due to its history of losses, Motiva USA LLC, our U.S. subsidiary, maintains a full valuation allowance for deferred tax assets including net operating loss carry-forwards, R&D tax credits, capitalized R&D and other book versus tax differences.
Current wording
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.
Previous wording
•Outlook: Demand for our products is dependent on the relative strength of the global and regional medical device markets, which are sensitive to general macroeconomic conditions. The current global macroeconomic environment remains complex, with elevated inflation and interest rates driving reductions in discretionary spending in the markets we operate. While several regions are showing strong performance, the demand remains inconsistent, with Latin America, especially Brazil, underperforming. We expect significant demand for our products as we further develop the U.S. market. Despite our continued emphasis on managing operating costs, our commercial and operational efforts have intensified post-FDA approval of Motiva Implants. Therefore, we expect an uptick in overall operating expenses in fiscal 2025 relative to fiscal 2024.
Current wording
•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 result, we expect overall operating expenses to increase as compared to 2025, although we remain focused on managing operating expenses.
Previous wording
Cost of revenue decreased $1.7 million, or 2.9%, to $56.5 million for the year ended December 31, 2024, compared to $58.2 million for the year ended December 31, 2023. The decrease in cost of revenue is primarily due to improved manufacturing efficiencies achieved at the new facility and the closure of the smallest manufacturing location.
Current wording
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.
Previous wording
Gross margin increased to 66.0% for the year ended December 31, 2024, compared to 64.8% for the year ended December 31, 2023 driven by a lower cost of revenue, as noted above, along with the favorable margin impact from sales within the United States due to higher selling prices.
Current wording
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.
Previous wording
SG&A expense decreased $5.8 million, or 4.0%, to $139.8 million for the year ended December 31, 2024, compared to $145.6 million for the year ended December 31, 2023. The decrease was primarily due to a $6.2 million decrease in in consulting fees, a $4.1 million decrease in sales and marketing expenses and a $3.6 million decrease in freight costs, partially offset by a $2.1 million increase in depreciation and amortization costs, a $1.5 million increase in personnel and related costs, a $1.3 million increase in insurance expenses, and a $1.1 million increase in software implementation costs.
Current wording
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.
Previous wording
R&D expense decreased $6.7 million, or 25.4%, to $19.7 million for the year ended December 31, 2024, compared to $26.4 million for the year ended December 31, 2023. The decrease in R&D expense was primarily due to a $6.0 million decrease in personnel cost and a $1.0 million decrease in expenditures related to our IDE clinical trial in the United States, partially offset by a $0.2 million increase in regulatory affairs costs.
Current wording
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.
Previous wording
Interest expense increased $5.4 million, or 35.1%, to $20.8 million for the year ended December 31, 2024, as compared to $15.4 million for the year ended December 31, 2023. The increase was primarily due to an increase in debt principal.
Current wording
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.
Previous wording
Other income (expense), net, decreased $15.6 million to an expense of $13.8 million for the year ended December 31, 2024, compared to an income of $1.8 million for the year ended December 31, 2023. The decrease 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 loss of $8.8 million, for the year ended December 31, 2024, compared to a gain of $1.8 million for the year ended December 31, 2023. Interest income amounted to $1.5 million or the year ended December 31, 2024, as compared to $1.0 million for the year ended December 31, 2023.
Current wording
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.
Previous wording
As of December 31, 2024, we had an accumulated deficit of $444.7 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, 2024 and 2023, we had cash of $90.3 million and $40.0 million, respectively.
Current wording
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.
Previous wording
Our short-term liquidity requirements consist primarily of operating expenses and interest payments on the Credit Agreement. 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 IDE clinical trial, 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.
Current wording
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.
Previous wording
Net cash used in operating activities of $88.5 million for the year ended December 31, 2023 was primarily comprised of a net loss of $78.5 million, changes in operating assets and liabilities of $34.1 million, $4.2 million of unrealized foreign currency gain and $3.6 million of interest capitalized for construction in progress, partially offset by $14.4 million of share-based compensation expense, $13.3 million of non-cash interest expense due to accretion of debt discounts, $4.2 million of non-cash depreciation and amortization expense, a $1.4 million change in provision for inventory obsolescence, a $1.2 million change in allowance for doubtful accounts and $0.7 million of non-cash amortization expense of right-to-use assets.
Current wording
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.
Previous wording
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 doubtful accounts, $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.
Current wording
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.
Previous wording
Net cash used in investing activities of $24.5 million for the year ended December 31, 2023 primarily consisted of $15.3 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, $7.9 million in purchases of property and equipment related to the new manufacturing facility and $1.3 million in purchases of intangibles.
Current wording
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.
Previous wording
Net cash provided by financing activities of $86.2 million for the year ended December 31, 2023 primarily consisted of $84.5 million of proceeds received for the issuance of common shares, net of underwriters’ discount and issuance costs, from our public offering in April 2023 and $2.2 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.
Current wording
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 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.
Previous wording
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. 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, 2024, $221.4 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 and $17.6 million of interest accrued into the principal balance. See Note 6 “Debt” for additional information.
Current wording
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.
Previous wording
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.
Current wording
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.
Previous wording
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 fifteen 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, 2024 and 2023, an allowance of $0.4 million and $0.3 million was recorded for product returns, respectively. Taxes collected from customers for remittance to governmental authorities are excluded from net sales.
Current wording
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.
Previous wording
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 recognizes 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 recognizes 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”).
Current wording
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”).
Previous wording
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 research and development activities.
Current wording
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.
Previous wording
Accounts receivable is stated at invoice value less estimated allowances for returns and credit losses. We continually monitor customer payments and maintains an allowance for estimated losses resulting from customers’ inability to make required payments. In evaluating our ability to collect outstanding receivable balances, we 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.
Current wording
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 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.
Previous wording
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$4.2 million and$3.9 million has been recorded as of December 31, 2024 and 2023, respectively.
Current wording
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.
Previous wording
We record uncertain tax positions based on a two-step process whereby (1) a determination is made as to whether it is more likely than not that the tax positions will be sustained based on the technical merits of the position and (2) for those tax positions that meet the more-likely-than-not recognition threshold we recognize the largest amount of tax benefit that is greater than 50% likely to be realized upon ultimate settlement with the related tax authority. Our policy is to recognize interest and penalties accrued on any unrecognized tax benefits as a component of income tax expense. Significant judgment is required in the identification of uncertain tax positions and in the estimation of penalties and interest on uncertain tax positions.
Current wording
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.
Previous wording
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, 2024, foreign currency transaction loss amounted to $8.8 million as compared to a foreign currency transaction gain of $1.8 million for the year ended December 31, 2023.
Current wording
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.
Previous wording
We 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 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.
Current wording
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.
Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
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.
Rearranged previous paragraphs (3)
Previous report — wording carried elsewhere
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
Previous report — wording carried elsewhere
We operate in various tax jurisdictions and are subject to audit by various tax authorities.
Previous report — wording carried elsewhere
There were no material uncertain tax positions as of December 31, 2024 and 2023.