ESTABLISHMENT LABS HOLDINGS INC.

Previous wording

Our revenue for the six months ended June 30, 2025 and 2024 was $92.7 million and $81.3 million, respectively, an increase of $11.4 million, or 14.0%. Net losses were $37.3 million for the six months ended June 30, 2025 as compared to $33.4 million for the six months ended June 30, 2024. As of June 30, 2025 we had an accumulated deficit of $482.0 million.

Current 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.

Previous wording

Our cash balance as of June 30, 2025 was $54.6 million.

Current wording

Our cash balance as of September 30, 2025 was $70.6 million.

Previous wording

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 $45.71, the 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.

Current wording

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 wording

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, 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.

Current wording

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 wording

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 95% of our revenues for the six months ended June 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.

Current wording

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 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 and enrolled the first patient in 2018. In September 2024, we received FDA approval for our Motiva Implants. As part of the post market approval condition requirements, in addition to the continuing follow-ups related to the IDE, the FDA requires a 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 engaged in an aesthetic procedure other than breast implants. PAS is a decade-long study that will enroll 2,400 patients divided into three cohorts across up to 50 study sites in the U.S. Enrollment for the study sites began in April 2025, with the first patients scheduled to be enrolled 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.

Current wording

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 wording

Our initial projections estimated the cost of the IDE clinical trial between $30.0 million and $40.0 million over the duration of the clinical trial period of ten years. As of June 30, 2025, approximately $32.9 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

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 wording

Interest expense consists primarily of cash and non-cash interest related to outstanding debt and amortization of debt discounts. As of June 30, 2025, 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 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 wording

•Financial Results: Outside the United States, we saw sequential growth in all our geographic regions in the second quarter of fiscal 2025 as compared to the first quarter. As compared to the prior year, demand in fiscal 2025 improved in our EMEA markets, especially direct markets. Latin America, and Brazil in particular, continues to suffer from weaker underlying demand for aesthetic and reconstructive plastic surgery; however, we are seeing stabilizing results in Brazil and continued strong growth in Argentina. 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 downturn 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.

Current wording

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 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 and expect a positive impact on our gross margins in 2025 correlated to the U.S. revenue growth. 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.

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 2024, although we remain focused on managing operating expenses.

Previous wording

Revenue increased $7.2 million, or 16.3%, to $51.3 million for the three months ended June 30, 2025 as compared to $44.1 million the three months ended June 30, 2024. The increase was primarily due to significantly higher sales in North America after FDA approval of Motiva Implants in September 2024, a 14.4% increase in revenue in the EMEA market and a 6.7% increase in revenue in Latin America, partially offset by a decrease in overall demand in Asia-Pacific, resulting in an approximately 46.4% decrease in revenue in the Asia-Pacific regions compared to the same period in fiscal 2024.

Current wording

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 wording

Cost of revenue increased $0.8 million, or 5.3%, for the three months ended June 30, 2025 compared to the three months ended June 30, 2024. The increase in cost of revenue is in line with the increase in revenue.

Current 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.

Previous wording

Gross margin increased to 68.8% for the three months ended June 30, 2025 as compared to 65.6% for the three months ended June 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 70.1% 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.

Previous wording

SG&A expense increased $11.4 million, or 34.8%, to $44.2 million for the three months ended June 30, 2025, compared to $32.8 million for the three months ended June 30, 2024. The increase in SG&A was primarily due to a $4.1 million increase in personnel and related costs, a $2.6 million increase in shipping & handling associated with higher sales, a $1.4 million increase in sales commissions, a $1.3 million increase in sales and marketing expenses, a $0.9 million increase in software implementation costs, a $0.7 million increase in depreciation and amortization expenses, and a $0.6 million increase in consulting fees, partially offset by a $0.3 million decrease in facilities costs and a $0.3 million decrease in insurance costs.

Current 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.

Previous wording

R&D expense decreased $0.3 million, or 5.5%, to $5.2 million for the three months ended June 30, 2025, compared to $5.5 million for the three months ended June 30, 2024 primarily due to a $0.9 million decrease in expenditures related to our IDE clinical trial in the United States and a $0.2 million decrease in stock compensation costs, partially offset by a $0.5 million increase in personnel costs and a $0.3 million increase in regulatory affairs costs.

Current wording

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 wording

Interest expense for the three months ended June 30, 2025 was $6.0 million as compared to $5.2 million for the three months ended June 30, 2024. The increase was primarily due to an increase in debt principal.

Current 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.

Previous wording

Other income (expense), net, increased $7.2 million to a gain of $4.4 million for the three months ended June 30, 2025, compared to a loss of $2.8 million for the three months ended June 30, 2024. The increase was primarily due to foreign currency fluctuations of the euro and the Brazilian real as compared to the U.S. dollar in the second quarter of 2025 compared to the second quarter of 2024, resulting in a foreign currency transaction gain of $5.0 million, the majority of which remains unrealized, for the three months ended June 30, 2025, compared to a $2.8 million loss for the three months ended June 30, 2024.

Current 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.

Previous wording

Revenue increased $11.4 million, or 14.0%, to $92.7 million for the six months ended June 30, 2025 as compared to $81.3 million for the six months ended June 30, 2024. The increase was primarily due to significantly higher sales in North America after FDA approval of Motiva Implants in September 2024 and a 9.2% increase in revenue in the EMEA market, partially offset by decreases in overall demand in Latin America and Asia-Pacific, resulting in an approximately 5.0% decrease in revenue in Latin-America as compared to the same period in fiscal 2024 and an approximately 35.0% decrease in revenue in the Asia-Pacific region as compared to the same period in fiscal 2024.

Current wording

Revenue increased $25.0 million, or 20.6%, to $146.5 million for the nine months ended September 30, 2025 as compared to $121.5 million for the nine 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 5.6% increase in revenue in the EMEA market and a 4.4% increase in revenue in Latin America partially offset by a decrease in Asia-Pacific, resulting in an approximately 22.5% decrease in revenue in the Asia-Pacific region as compared to the same period in fiscal 2024.

Previous wording

Cost of revenue increased $1.6 million, or 5.7%, to $29.6 million for the six months ended June 30, 2025 compared to $28.0 million for the six months ended June 30, 2024. The increase in cost of revenue is in line with the increase in revenue.

Current wording

Cost of revenue increased $3.2 million, or 7.5%, to $45.7 million for the nine months ended September 30, 2025 compared to $42.5 million for the nine months ended September 30, 2024. The increase in cost of revenue is in line with the increase in revenue.

Previous wording

Gross margin increased to 68.1% for the six months ended June 30, 2025 compared to 65.6% for the six months ended June 30, 2024, primarily due to the favorable impact from sales within the United States due to higher selling prices in that region.

Current wording

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 wording

SG&A expense increased $22.2 million, or 36.0%, to $83.9 million for the six months ended June 30, 2025, compared to $61.7 million for the six months ended June 30, 2024. The increase in SG&A was primarily due to a $6.9 million increase in personnel and related costs, a $3.7 million in shipping & handling associated with higher sales, a $3.3 million increase in commissions, a $3.0 million increase in sales and marketing expenses, a $1.6 million increase in depreciation and amortization expenses, a $1.4 million increase in bad debt expense, a $0.9 million increase in software implementation costs, and a $0.7 million increase in facilities costs, partially offset by a $0.4 million decrease in consulting fees.

Current wording

SG&A expense increased $25.2 million, or 26.3%, to $121.0 million for the nine months ended September 30, 2025, compared to $95.8 million for the nine months ended September 30, 2024. The increase in SG&A was primarily due to a $6.7 million increase in personnel and related costs, a $4.7 million increase in commissions, a $4.5 million increase in shipping & handling associated with higher sales, a $2.0 million increase in sales and marketing expenses, a $2.0 million increase in depreciation and amortization expenses, a $1.4 million increase in consulting fees, a $1.3 million increase in bad debt expense, a $0.9 million increase in software implementation costs, a $0.6 million increase in facilities costs and a $0.3 million increase in insurance expenses.

Previous wording

R&D expense increased $0.5 million, or 5.1%, to $10.3 million for the six months ended June 30, 2025, compared to $9.8 million for the six months ended June 30, 2024. The increase in R&D expense was primarily due to a $1.2 million increase in personnel cost and a $0.3 million increase in regulatory affairs costs, partially offset by a

Current wording

R&D expense increased $0.2 million, or 1.4%, to $14.8 million for the nine months ended September 30, 2025, compared to $14.6 million for the nine months ended September 30, 2024. The increase in R&D expense was primarily due to a $1.8 million increase in personnel cost and a $0.2 million increase in regulatory affairs costs, partially offset by a $1.1 million decrease in expenditures related to our IDE clinical trial in the United States and a $0.6 million decrease in stock compensation costs.

Previous wording

Interest expense was $11.8 million for the six months ended June 30, 2025, compared to $9.6 million for the six months ended June 30, 2024. The increase was primarily due to an increase in debt principal.

Current wording

Interest expense was $18.0 million for the nine months ended September 30, 2025, compared to $14.9 million for the nine months ended September 30, 2024. The increase was primarily due to an increase in debt principal.

Previous wording

Provision for income taxes increased $1.0 million to $1.9 million for the six months ended June 30, 2025, compared to $0.9 million for the six months ended June 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

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.

Previous wording

Other income (expense), net increased $12.9 million to a gain of $7.1 million for the six months ended June 30, 2025, compared to a loss of $5.8 million for the six months ended June 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 $7.8 million, the majority of which remains unrealized, for the six months ended June 30, 2025, compared to a $5.8 million loss for the six months ended June 30, 2024.

Current wording

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 wording

As of June 30, 2025, we had an accumulated deficit of $482.0 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 June 30, 2025 and December 31, 2024, we had cash of $54.6 million and $90.3 million, respectively.

Current 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.

Previous wording

Net cash used in operating activities of $39.5 million for the six months ended June 30, 2025 was primarily comprised of a net loss of $37.3 million, changes in operating assets and liabilities of $9.2 million and $9.5 million of unrealized foreign currency gain, partially offset by $5.6 million of share-based compensation expense, $4.7 million of non-cash depreciation and amortization expense, a $2.0 million change in allowance for credit losses, $1.6 million of non-cash interest expense due to accretion of debt discounts, $1.5 million change in provision for inventory obsolescence, a $0.5 million loss on contract termination, $0.5 million of right-to-use asset amortization and $0.2 million in stock compensation in lieu of cash fees.

Current 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.

Previous wording

Net cash used in operating activities of $25.3 million for the six months ended June 30, 2024 was primarily comprised of a net loss of $33.4 million, changes in operating assets and liabilities of $12.1 million and $0.6 million of interest capitalized for construction in progress, partially offset by $7.2 million of share-based compensation expense, $5.0 million of non-cash interest expense due to accretion of debt discounts, $4.4 million of unrealized foreign currency loss, $2.7 million of non-cash depreciation and amortization expense, a $0.5 million change in provision for inventory obsolescence, a $0.4 million change in allowance for credit losses and $0.3 million of right-to-use asset amortization.

Current 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.

Previous wording

Net cash used in investing activities of $3.4 million for the six months ended June 30, 2025 primarily reflected $2.4 million in purchases of property and equipment, $0.7 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 $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.

Previous wording

Net cash used in investing activities of $11.0 million for the six months ended June 30, 2024 primarily consisted of $4.8 million in costs incurred for intangible assets primarily driven by the development of an enterprise resource planning system for the anticipated U.S. launch of Motiva Implants, $4.1 million in purchases of property and equipment primarily related to the new manufacturing facility, and $2.2 million of cash paid for capital expenditures on construction in progress related to our new manufacturing facility in the CFZ in Costa Rica.

Current wording

Net cash used in investing activities of $13.8 million for the nine months ended September 30, 2024 primarily consisted of $5.9 million in costs incurred for intangible assets primarily driven by the development of an enterprise resource planning system for the anticipated U.S. launch of Motiva Implants, $5.6 million in purchases of property and equipment primarily related to the new manufacturing facility, and $2.3 million of cash paid for capital expenditures on construction in progress related to our new manufacturing facility in the CFZ in Costa Rica.

Previous wording

Net cash provided by financing activities of $4.9 million for the six months ended June 30, 2025 primarily reflected $5.0 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 $0.4 million paid to satisfy tax withholding obligations upon the vesting of restricted stock.

Current 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.

Previous wording

Net cash provided by financing activities of $51.4 million for the six months ended June 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 $2.0 million in proceeds received for stock option exercises partially offset by $0.3 million paid to satisfy tax withholding obligations upon the vesting of restricted stock.

Current 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.

Previous wording

On April 26, 2022, or the Closing Date, we entered into the Credit Agreement, pursuant to which the Lenders agreed to make term loans to the Company 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 the Madryn Credit Agreement in full, including the early repayment penalty of $6.5 million. In December 2022, we qualified to borrow and received an advance of $25 million under the second tranche and, in October 2024, we qualified to borrow and received an advance of an additional $25 million under the third tranche. In February 2024, we amended the Credit Agreement to modify the access conditions, commitment termination dates and interest rates for the two then-remaining available tranches, Tranche C Term Loans and Tranche D Term Loans. Our ability to draw down the Tranche D Term Loan under the Credit Agreement will depend on our ability to satisfy the gross sales thresholds required to advance the tranches by the dates specified.

Current wording

On April 26, 2022, or the Closing Date, we entered into the Credit Agreement, pursuant to which the Lenders agreed to make term loans to the Company 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 the Madryn Credit Agreement in full, including the early repayment penalty of $6.5 million. In December 2022, we qualified to borrow and received an advance of $25 million under the second tranche and, in October 2024, we qualified to borrow and received an advance of an additional $25 million under the third tranche. In February 2024, we amended the Credit Agreement to modify the access conditions, commitment termination dates and interest rates for the two then-remaining available tranches, Tranche C Term Loans and Tranche D Term Loans. Our ability to draw down the Tranche D Term Loan under the Credit Agreement was dependent on our ability to satisfy the gross sales thresholds required to advance the tranches by the dates specified. In September 2025, we qualified to borrow and received an advance of an additional $25 million under the fourth tranche.

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 June 30, 2025, $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 $21.4 million of interest accrued into the principal balance.

Current 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.

Previous wording

We identified certain critical accounting policies that affect certain of our more significant estimates and assumptions used in preparing our consolidated financial statements for the year ended December 31, 2024 included in our Annual Report on Form 10-K filed with the SEC on February 28, 2025, which we disclosed in Part II, Item 7, Management’s Discussion and Analysis of Financial Condition and Results of Operations―Critical

Current wording

We identified certain critical accounting policies that affect certain of our more significant estimates and assumptions used in preparing our consolidated financial statements for the year ended December 31, 2024 included in our Annual Report on Form 10-K filed with the SEC on February 28, 2025, which we disclosed in Part II, Item 7, Management’s Discussion and Analysis of Financial Condition and Results of Operations―Critical Accounting Policies, Significant Judgments and Use of Estimates in the Annual Report on Form 10-K. We have not made any material changes to these policies as previously disclosed in the Form 10-K.