ESTABLISHMENT LABS HOLDINGS INC.
For the period ended Mar 31, 2026. Filed May 8, 2026.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Mar 31, 2026 · Filed May 8, 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-Q
Period ended 2025-09-30; filed 2025-11-07.
0001688757-25-000065
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-03-31; filed 2026-05-08.
0001688757-26-000041
Item 2. 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 114 previous paragraphs and 66 current paragraphs.
30 unchanged; 24 reworded; 11 added; 55 removed; 5 previous and 1 current paragraphs rearranged.
Tables are not compared: 6 previous and 4 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 (11)
Current report
On February 24, 2026, the Company announced a strategic leadership transition of Raj Denhoy, the then-current Chief Financial Officer, to Senior Vice President, Global Strategy, and the appointment of Cassandra “Sandra” Harris to Senior Vice President and Chief Financial Officer, effective March 9, 2026.
Current report
Revenue increased $18.5 million, or 44.7%, to $59.9 million for the three months ended March 31, 2026 as compared to $41.4 million for the three months ended March 31, 2025. The increase was primarily due to a $13.5 million increase in sales in the United States. Outside of the United States, sales increased by $5.0 million primarily in the Asia-Pacific region and Latin America while sales in EMEA remained relatively stable.
Current report
Cost of Revenue and Gross Margin
Current report
Operating Expenses
Current report
R&D expense remained relatively consistent at $5.2 million for the three months ended March 31, 2026, compared to $5.1 million for the three months ended March 31, 2025.
Current report
Interest Expense
Current report
Provision for income taxes decreased $0.6 million, or 66.7%, to $0.3 million for the three months ended March 31,
Current report
Other Income, Net
Current report
As described above under “Recent Developments - Financing Activities,” in April 2026, we entered into the Amended Credit Agreement, which provided for new term loans in an aggregate principal amount of up to $300 million. The first tranche was advanced in the amount of $265 million on April 30, 2026. Approximately $259 million of the proceeds from the Tranche E Term Loan was used to repay in full outstanding obligations under the Credit Agreement and transaction costs in connection with the New Term Loans. See Note 16 “Subsequent Events” for additional information regarding the Amended Credit Agreement.
Current report
Net Cash Used in/Provided by Financing Activities
Current report
On April 30, 2026, we entered into the Amended Credit Agreement, which provided for new term loans in an aggregate principal amount of up to $300 million. The first tranche was advanced in the amount of $265 million on April 30, 2026. Approximately $259 million of the proceeds from the Tranche E Term Loan was used to repay in full outstanding obligations under the Credit Agreement and transaction costs in connection with the New Term Loans. See Note 16 “Subsequent Events” for additional information regarding the Amended Credit Agreement.
Removed paragraphs (55)
Previous 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’.
Previous report
On May 7, 2025, we announced the appointment of Peter Caldini as Chief Executive Officer.
Previous report
On March 6, 2025, we announced a partnership with GRAMMY Award-winning singer-songwriter Meghan Trainor.
Previous report
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.
Previous report
In January 2025, we announced the retirement of Juan José Chacón-Quirós as CEO, effective March 1, 2025. Peter Caldini, our current President, began serving as Interim CEO, effective the same day. Following his departure as Chief Executive Officer, Mr. Chacón-Quirós continues to serve as a member of the Board and as an advisor with the Company.
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 obtained necessary regulatory approvals to commence manufacturing. We incurred approximately $56.0 million in costs for this phase of the project. 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 follow 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 in 2023.
Previous 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 $10.0 million in a funding period. Under the Funding Agreement, the Funding Providers will finance, upon request, eligible invoices at a 12.0% annual interest rate for an initial four-month term, or a later date if agreed by the Funding Providers in writing in their sole discretion. On June 20, 2025, we drew $5.0 million and recorded this liability in "Other Liabilities, Short-Term".
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. On August 31, 2025, we issued 76,569 additional common shares and additional pre-funded warrants to purchase up to 32,814 common shares in accordance with the securities purchase agreement for no additional consideration since 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 did not exceed $45.71, the price per common share sold in the offering. The pre-funded warrants are exercisable immediately, at a price of $0.001 per share, until exercised in full. 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
In February 2024, we entered into a Second Amendment to the Credit Agreement, which provides for term loans to the Company 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,
Previous report
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. The Tranche D Term Loan of $25 million was advanced in September 2025 at the Company’s election 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 to sell 1,101,565 common shares and pre-funded warrants to purchase 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
Components of Results of Operations
Previous report
We commenced sales of our Motiva Implants in October 2010, which have historically accounted for the majority of our revenues. Sales of our Motiva Implants accounted for over 96% of our revenues for the nine months ended September 30, 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 report
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.
Previous report
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.
Previous report
Our implants are manufactured at our facilities in Costa Rica. Construction of our new facility in Costa Rica was completed in June 2024. Subsequently, the smallest manufacturing facility ceased production in September 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.
Previous report
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.
Previous report
Sales, General and Administrative
Previous report
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 include costs attributable to freight, marketing, sales support, travel, legal services, financial audit fees, insurance costs, and consulting services.
Previous report
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.
Previous report
Research and Development
Previous report
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.
Previous report
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 approval of the IDE from the FDA and enrolled the first patient in 2018. In September 2024, we received FDA approval for our Motiva Implants for the augmentation cohorts.
Previous report
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 U.S. 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 PAS over the next 10 years.
Previous report
Our initial projections estimated the cost of the IDE clinical trial to be between $30.0 million and $40.0 million over the duration of the clinical trial period of ten years. As of September 30, 2025, approximately $33.2 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.
Previous report
Interest expense consists primarily of cash and non-cash interest related to outstanding debt and amortization of debt discounts. As of September 30, 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 report
Other income (expense), net primarily consists of foreign currency gains/losses and interest income.
Previous report
Income Tax Expense
Previous report
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.
Previous report
Business Update Regarding Macroeconomic Conditions
Previous report
Financial Results: As compared to the prior year, demand year-to-date 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 still selling 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. By September 30, 2025, we had successfully secured over 1,300 accounts across the United States, and Motiva Implants generated $28.3 million in sales within the United States for the nine months ended September 30, 2025.
Previous report
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 2024, although we remain focused on managing operating expenses.
Previous report
For additional information on the various risks and other uncertain macroeconomic conditions on our business, financial condition and results of operations, please see Part II, Item 1A, “Risk Factors” in this Quarterly Report on Form 10-Q.
Previous report
Comparison of Three Months Ended September 30, 2025 and 2024
Previous report
Revenue
Previous report
Revenue increased $13.6 million, or 33.8%, to $53.8 million for the three months ended September 30, 2025 as compared to $40.2 million the three months ended September 30, 2024. The increase was primarily due to significantly higher sales in North America after FDA approval of Motiva Implants in September 2024, a 21.7% increase in revenue in Latin America and a 3.0% increase in revenue in the Asia-Pacific regions, partially offset by a decrease in overall demand in EMEA, resulting in an approximately 2.1%% decrease in revenue in the EMEA market as compared to the same period in fiscal 2024.
Previous report
R&D expense decreased $0.2 million, or 4.2%, to $4.6 million for the three months ended September 30, 2025, compared to $4.8 million for the three months ended September 30, 2024 primarily due to a $0.4 million decrease in expenditures related to our IDE clinical trial in the United States, a $0.3 million decrease in stock compensation costs, a $0.1 million decrease in regulatory affairs costs partially offset by an $0.6 million increase in personnel costs.
Previous report
Provision for income taxes remained relatively stable at $0.4 million for the three months ended September 30, 2025, compared to $0.5 million for the three months ended September 30, 2024.
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Reworded paragraphs (24)
Previous wording
You should read the following discussion and analysis of our financial condition and results of operations together with the condensed consolidated financial statements and related notes that are included elsewhere in this Quarterly Report on Form 10-Q. 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 “Risk Factors,” in Part II, Item 1A of this Quarterly Report on Form 10-Q. See “Special Note Regarding Forward-Looking Statements” above.
Current wording
You should read the following discussion and analysis of our financial condition and results of operations together with the condensed consolidated financial statements and related notes that are included elsewhere in this Quarterly Report on Form 10-Q. 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 “Risk Factors,” in Part I, Item 1A. of our Form 10-K filed with the Securities and Exchange Commission, or SEC, on February 27, 2026. See “Special Note Regarding Forward-Looking Statements” above.
Previous wording
Our line of silicone gel-filled breast implants, branded as Motiva Implants, is the centerpiece of our medical technology platform and, to date, are commercially available in over 90 countries, including, most recently, in the United States. 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
In September 2024, we received FDA approval to sell Motiva Implants in the United States. In October 2023, the FDA granted 510(k) clearance for the Motiva Flora SmoothSilk Tissue Expander.
Current wording
In September 2024, we received FDA approval to sell Motiva Implants in the United States.
Previous wording
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.
Current wording
On April 30, 2026, we entered into an Amended and Restated Credit Agreement and Guaranty, or the Amended Credit Agreement, together with certain of our subsidiaries as guarantors, the lenders from time to time party thereto, or the Lenders, and Oaktree Fund Administration, LLC, as administrative agent for the Lenders, pursuant to which the Lenders agreed to make term loans to the Company in an aggregate principal amount of up to $300 million. The first tranche was advanced in the amount of $265 million on April 30, 2026. Approximately $259 million of the proceeds from the Tranche E Term Loan was used to repay in full the obligations under the Credit Agreement and transaction costs in connection with the New Term Loans. See Note 16 “Subsequent Events” for additional information.
Previous wording
Our revenue for the nine months ended September 30, 2025 and 2024 was $146.5 million and $121.5 million, respectively, an increase of $25.0 million, or 20.6%. Net losses were $48.4 million for the nine months ended September 30, 2025 as compared to $50.1 million for the nine months ended September 30, 2024. As of September 30, 2025, we had an accumulated deficit of $493.1 million.
Current wording
Our revenue for the three months ended March 31, 2026 and 2025 was $59.9 million and $41.4 million, respectively, an increase of $18.5 million, or 44.7%. Net losses were $13.4 million for the three months ended March 31, 2026 as compared to $20.7 million for the three months ended March 31, 2025. As of March 31, 2026 we had an accumulated deficit of $509.1 million.
Previous wording
Our cash balance as of September 30, 2025 was $70.6 million.
Current wording
Our cash balance as of March 31, 2026 was $68.1 million.
Previous wording
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.
Current wording
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 in our Annual Report on Form 10-K are essential to understanding our historical and future performance, as these policies relate to the more significant areas involving management’s estimates and judgments.
Previous wording
In October 2024, we completed and announced the results of the three-year 100-patient clinical study for Mia Femtech, our patented technologies 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 participation of fifteen board-certified plastic surgeons in multiple geographies. We now offer Mia Femtech in over 30 cities across the world with over 80 plastic surgeons fully certified to provide the Mia experience.
Current wording
Comparison of the Three Months Ended March 31, 2026 and 2025
Previous wording
Cost of revenue increased $1.6 million, or 11.0%, for the three months ended September 30, 2025 compared to the three months ended September 30, 2024. The increase in cost of revenue is in line with the increase in revenue.
Current wording
Cost of revenue increased $3.9 million, or 28.7%, to $17.5 million for the three months ended March 31, 2026 compared to $13.6 million for the three months ended March 31, 2025. The increase in cost of revenue is in line with the increase in revenue.
Previous wording
Gross margin increased to 70.1% for the three months ended September 30, 2025 as compared to 63.9% for the three months ended September 30, 2024, primarily attributable to the favorable impact from sales within the United States due to higher selling prices in that region.
Current wording
Gross margin increased to 70.7% for the three months ended March 31, 2026 compared to 67.2% for the three months ended March 31, 2025, primarily due to a favorable impact from sales within the United States due to higher selling prices in that region partially offset by an increase in inventory obsolescence reserve.
Previous wording
SG&A expense increased $3.1 million, or 9.1%, to $37.2 million for the three months ended September 30, 2025, compared to $34.1 million for the three months ended September 30, 2024. The increase in SG&A was primarily due to a $1.7 million increase in consulting fees, a $1.4 million increase in sales commissions, a $0.8 million increase in shipping & handling associated with higher sales, a $0.3 million increase in depreciation and amortization expenses and a $0.2 million increase in insurance costs partially offset by a $1.0 million decrease in sales and marketing expenses, a $0.2 million decrease in personnel and related costs and a $0.1 million decrease in bad debt expense.
Current wording
SG&A expense increased $3.9 million, or 9.8%, to $43.6 million for the three months ended March 31, 2026, compared to $39.7 million for the three months ended March 31, 2025. The increase in SG&A was primarily due to an increase in personnel and consulting costs and freight associated with higher sales partially offset by a decrease in bad debt expense and sales and marketing expenses.
Previous wording
Interest expense for the three months ended September 30, 2025 was $6.2 million as compared to $5.3 million for the three months ended September 30, 2024. The increase was primarily due to an increase in debt principal.
Current wording
Interest expense was $7.1 million for the three months ended March 31, 2026, compared to $5.9 million for the three months ended March 31, 2025. The increase was primarily due to an increase in debt principal.
Previous wording
Provision for income taxes increased $0.9 million to $2.3 million for the nine months ended September 30, 2025, compared to $1.4 million for the nine months ended September 30, 2024. The change in the provision for income taxes is primarily due to an increase in pre-tax income in certain US and foreign jurisdictions.
Current wording
2026, compared to $0.9 million for the three months ended March 31, 2025. The change in the provision for income taxes is primarily due to a decrease in pre-tax income in certain foreign jurisdictions.
Previous wording
Other income (expense), net, decreased $2.5 million to a loss of $0.5 million for the three months ended September 30, 2025, compared to a gain of $2.0 million for the three months ended September 30, 2024. The decrease was primarily due to foreign currency fluctuations of the euro and the Brazilian real as compared to the U.S. dollar in the third quarter of 2025 compared to the third quarter of 2024, resulting in a foreign currency transaction loss of $0.4 million, the majority of which remains unrealized, for the three months ended September 30, 2025, compared to a $2.2 million gain for the three months ended September 30, 2024.
Current wording
Other income, net decreased $2.3 million to a gain of $0.5 million for the three months ended March 31, 2026, compared to a gain of $2.8 million for the three months ended March 31, 2025. The decrease was primarily due to the foreign currency fluctuations of the Brazilian real and euro as compared to the U.S. dollar in fiscal 2026 and 2025, resulting in a foreign currency transaction loss of $0.3 million, the majority of which remains unrealized, for the three months ended March 31, 2026, compared to a $2.8 million gain for the three months ended March 31, 2025.
Previous wording
As of September 30, 2025, we had an accumulated deficit of $493.1 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 September 30, 2025 and December 31, 2024, we had cash of $70.6 million and $90.3 million, respectively.
Current wording
As of March 31, 2026, we had an accumulated deficit of $509.1 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 March 31, 2026 and December 31, 2025, we had cash of $68.1 million and $75.6 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 in our Annual Report on Form 10-K for the year ended December 31, 2024 under “Material Cash Requirements.” Our long-term liquidity needs consist primarily of operating expenses, including 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. 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 Amended 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 in our Annual Report on Form 10-K for the year ended December 31, 2025 under “Material Cash Requirements.” 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 above). Our liquidity assumptions may prove to be incorrect, and we could utilize our available financial resources sooner than we currently expect.
Previous wording
▪the degree and rate of market adoption of our products, particularly our Motiva Implants;
Current wording
▪the degree and rate of market adoption of our products;
Previous wording
Net cash used in operating activities of $37.8 million for the nine months ended September 30, 2024 was primarily comprised of a net loss of $50.1 million, changes in operating assets and liabilities of $13.2 million and $0.6 million of interest capitalized for construction in progress, partially offset by $10.9 million of share-based compensation expense, $5.6 million of non-cash interest expense due to accretion of debt discounts, $4.7 million of non-cash depreciation and amortization expense, $1.9 million of unrealized foreign currency loss, a $1.0 million change in allowance for credit losses, a $0.8 million change in provision for inventory obsolescence, $0.9 million in stock compensation in lieu of cash fees, and $0.5 million of right-to-use asset amortization.
Current wording
Net cash used in operating activities of $4.3 million for the three months ended March 31, 2026 was primarily comprised of a net loss of $13.4 million, partially offset by $3.0 million of share-based compensation expense, $2.5 million of non-cash depreciation and amortization expense, $1.3 million change in provision for inventory obsolescence, $1.1 million change in operating assets and liabilities and $1.1 million of non-cash interest expense due to accretion of debt discounts.
Previous wording
Net cash used in operating activities of $50.7 million for the nine months ended September 30, 2025 was primarily comprised of a net loss of $48.4 million, changes in operating assets and liabilities of $16.9 million and $10.0 million of unrealized foreign currency gain, partially offset by $8.5 million of share-based compensation expense, $7.1 million of non-cash depreciation and amortization expense, a $2.8 million change in allowance for credit losses, $2.6 million of non-cash interest expense due to accretion of debt discounts, $2.2 million change in provision for inventory obsolescence, $0.6 million of right-to-use asset amortization, a $0.5 million loss on contract termination, and $0.3 million in stock compensation in lieu of cash fees.
Current wording
Net cash used in operating activities of $20.7 million for the three months ended March 31, 2025 was primarily comprised of a net loss of $20.7 million, $5.2 million change in operating assets and liabilities, and $3.5 million of unrealized foreign currency gain, partially offset by $2.4 million of share-based compensation expense, $2.3 million of non-cash depreciation and amortization expense, a $1.7 million change in allowance for credit losses, $0.8 million of non-cash interest expense due to accretion of debt discounts, $0.7 million change in provision for inventory obsolescence, a $0.4 million loss from disposal of property and equipment, $0.2 million of right-to-use asset amortization and $0.1 million in stock compensation in lieu of cash fees.
Previous wording
Net cash used in investing activities of $5.4 million for the nine months ended September 30, 2025 primarily reflected $4.2 million in purchases of property and equipment, $0.8 million in costs incurred for intangible assets primarily driven by the development of an enterprise resource planning system for the U.S, and $0.3 million in cash paid related to business acquisitions of Motiva Benelux BV and Motiva NL BV.
Current wording
Net cash used in investing activities of $1.3 million for the three months ended March 31, 2025 primarily consisted $0.8 million in purchases of property and equipment, $0.3 million in cash paid related to business acquisitions of Motiva Benelux BV and Motiva NL BV and $0.3 million in costs incurred for intangible assets primarily driven by the development of an enterprise resource planning system for the U.S. launch of Motiva Implants.
Previous wording
Net cash provided by financing activities of $34.4 million for the nine months ended September 30, 2025 primarily reflected $24.5 million in proceeds received from 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 $0.4 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 used in financing activities of $0.9 million for the three months ended March 31, 2026 primarily reflected a $1.2 million repayment of short-term notes payable for insurance premium financing and $0.7 million paid to satisfy tax withholding obligations upon the vesting of restricted stock, partially offset by $1.0 million in proceeds received for stock option exercises.
Previous wording
Net cash provided by financing activities of $51.4 million for the nine months ended September 30, 2024 primarily reflected $49.7 million of proceeds received for the issuance of common shares and pre-funded warrants, net of offering expenses, from our private placement offering in January 2024 and $2.1 million in proceeds received for stock option exercises partially offset by $0.4 million paid to satisfy tax withholding obligations upon the vesting of restricted stock.
Current wording
Net cash provided by financing activities of $0.2 million for the three months ended March 31, 2025 primarily reflected $0.3 million paid to satisfy tax withholding obligations upon the vesting of restricted stock, partially offset by $0.1 million in proceeds received for stock option exercises
Previous wording
Our material cash requirements have not changed materially from those included in our Annual Report on Form 10-K filed with the SEC on February 28, 2025.
Current wording
Other than as described above with respect to the Amended Credit Agreement, our material cash requirements have not changed materially from those included in our Annual Report on Form 10-K filed with the SEC on February 27, 2026.
Previous wording
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 Tranche A and Tranche B, 10% per annum for Tranche C and Tranche D, or, at any time following the Tranche C Funding Milestone and the Administrative Agent’s receipt of evidence that a gross sale threshold of $225 million in trailing twelve month gross sales have been met, 8.25% per annum. As of September 30, 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.
Current wording
As of March 31, 2026, $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 “Liquidity and Capital Resources” above and Note 6 “Debt” for additional information.
Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
Net cash used in investing activities of $2.0 million for the three months ended March 31, 2026 primarily reflected $1.9 million in purchases of property and equipment primarily driven by the development of an enterprise resource planning system for the U.S. legal entity.
Rearranged previous paragraphs (5)
Previous report — wording carried elsewhere
ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Previous report — wording carried elsewhere
Gross margin increased to 68.8% for the nine months ended September 30, 2025 compared to 65.0% for the nine months ended September 30, 2024, primarily due to the favorable impact from sales within the United States due to higher selling prices in that region.
Previous report — wording carried elsewhere
Other income (expense), net increased $10.4 million to a gain of $6.6 million for the nine months ended September 30, 2025, compared to a loss of $3.8 million for the nine months ended September 30, 2024. The increase was primarily due to the foreign currency fluctuations of the Brazilian real and euro as compared to the U.S. dollar in fiscal 2025 and 2024, resulting in a foreign currency transaction gain of $7.4 million, the majority of which remains unrealized, for the nine months ended September 30, 2025, compared to a $3.6 million loss for the nine months ended September 30, 2024.
Previous report — wording carried elsewhere
Net Cash Provided by Financing Activities
Previous report — wording carried elsewhere
See “Liquidity and Capital Resources” above and Note 6 “Debt” for additional information.