ESTABLISHMENT LABS HOLDINGS INC

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 registered to be sold more than 85 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 and, to date, are commercially available in 95 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.

Previous wording

Our revenue for the nine months ended September 30, 2024 and 2023 was $121.5 million and $133.6 million, respectively, a decrease of $12.1 million, or 9.1%. Net losses were $50.1 million for the nine months ended September 30, 2024 as compared to $58.0 million for the nine months ended September 30, 2023. As of September 30, 2024 we had an accumulated deficit of $410.2 million.

Current wording

Our revenue for the three months ended March 31, 2025 and 2024 was $41.4 million and $37.2 million, respectively, an increase of $4.2 million, or 11.3%. Net losses were $20.7 million for the three months ended March 31, 2025 as compared to $16.2 million for the three months ended March 31, 2024. As of March 31, 2025 we had an accumulated deficit of $465.4 million.

Previous wording

Our cash balance as of September 30, 2024 was $39.7 million.

Current wording

Our cash balance as of March 31, 2025 was $69.2 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 of the Company at a purchase price of $45.71 per share and, in lieu of common shares to certain purchasers who so chose, pre-funded warrants to purchase up to 328,154 common shares at a purchase price of $45.709 per pre-funded warrant, which represents the price per share at which the common shares are being sold to the purchasers in the offering, minus $0.001, which is the exercise price of each pre-funded warrant. 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, which in the aggregate equals ten percent of the aggregate number of common shares and pre-funded warrants to purchase common shares being sold in the offering. These additional securities will be issuable for no additional consideration if the average closing price of our common shares on The Nasdaq Capital Market during the period from January 1, 2025 to August 31, 2025 does not exceed $45.71, which is the price per common share sold in the offering. The aggregate gross proceeds from the offering, before deducting offering expenses, will be approximately $50.0 million. The offering closed on November 12, 2024.

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. 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.

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 milestone triggering the availability of the Tranche D Term Loans to provide for availability of the Tranche D Term Loans upon achieving trailing twelve month gross sales of $195 million, including trailing twelve month gross sales of $30 million in the U.S. with respect to Motiva Implants and the Motiva Flora Tissue Expander product. The terms of the Tranche A Term Loans, Tranche B and Tranche C Term Loans were not modified.

Current 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.

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 nine months ended September 30, 2024, and we expect our revenues to continue to be driven primarily by sales of these products.

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 95% of our revenues for the three months ended March 31, 2025, and we expect our revenues to continue to be driven primarily by sales of these products.

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 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.

Current wording

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 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 September 30, 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

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 March 31, 2025, approximately $32.8 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 September 30, 2024, we had $196.4 million in outstanding principal under our term loan, including interest accrued into the principal balance. See Note 5 “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 March 31, 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.

Previous wording

Income tax expense consists primarily of income taxes in foreign jurisdictions in which we conduct business. Due to our history of losses, with the exception of Belgium and JAMM Technologies, Inc., we maintain 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 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 wording

•Financial Results: Demand in fiscal 2024 improved from the second half of fiscal 2023. Latin America, Brazil in particular, which remains our largest single market, continues to suffer from weaker underlying demand for aesthetic and reconstructive plastic surgery as compared to fiscal 2023.

Current wording

•Financial Results: Demand in fiscal 2025 improved in our EMEA market. Latin America, Brazil in particular, continues to suffer from weaker underlying demand for aesthetic and reconstructive plastic surgery compared to prior year; however, we saw a slight increase in revenue this quarter as compared to the fourth quarter of fiscal 2024. Our revenue in our Asia-Pacific market, China specifically, decreased as compared to the corresponding period of the prior year primarily due to our China distributor selling through inventory purchased in fiscal 2024 in preparation for commercial operations. This is a normal trajectory for a new distributor market, particularly one the size and complexity of China. In September 2024, we received FDA approval to sell Motiva Implants in the United States and continue to see strong demand from the plastic surgeon community and positive feedback. Motiva Implants generated $6.2 million in sales within the United States in the first quarter of 2025, and we foresee this momentum accelerating in the quarters ahead.

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. 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 in the press. We expect higher selling prices in the United States and the introduction of other new products will positively impact gross margins in 2025. While we are still very focused on managing operating expenses, our commercial and operational activities will increase following the FDA approval of Motiva Implants. As a result, we expect overall operating expenses will rise as compared to the previous quarters.

Current 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 escalating trade tensions, 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 a good performance, 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.

Previous wording

Revenue increased $1.7 million, or 4.4%, to $40.2 million for the three months ended September 30, 2024 as compared to $38.5 million the three months ended September 30, 2023. The increase was primarily due to an increase in demand in the Asia-Pacific region, resulting in an approximately 346% increase in revenue in this region as compared to the same period in fiscal 2023, and was partially offset by a decrease in the EMEA and Latin American regions, resulting in an approximately 19% decrease in revenue in these regions compared to the same period in 2023. We believe the decrease in demand for aesthetic procedures in certain affected regions is a result of continuing general uncertainty about macroeconomic conditions, as well as seasonality. These conditions have continued in certain markets in 2024.

Current wording

Revenue increased $4.2 million, or 11.3%, to $41.4 million for the three months ended March 31, 2025 as compared to $37.2 million for the three months ended March 31, 2024. The increase was primarily due to significantly higher sales in North America after FDA approval of Motiva Implants in September 2024 and a 4% increase in revenue in the EMEA market, partially offset by decreases in overall demand in Latin America and Asia-Pacific, resulting in an approximately 17% decrease in revenue in Latin-America as compared to the same period in fiscal 2024 and an approximately 14% decrease in revenue in the Asia-Pacific region as compared to the same period in fiscal 2024.

Previous wording

Cost of revenue increased $2.0 million, or 16.0%, for the three months ended September 30, 2024 compared to the three months ended September 30, 2023. The increase in cost of revenue is in line with the increase in revenue except as described below.

Current wording

Cost of revenue increased $0.8 million, or 6.2%, to $13.6 million for the three months ended March 31, 2025 compared to $12.8 million for the three months ended March 31, 2024. The increase in cost of revenue is in line with the increase in revenue.

Previous wording

SG&A expense decreased $5.9 million, or 14.8%, to $34.1 million for the three months ended September 30, 2024, compared to $40.0 million for the three months ended September 30, 2023. The decrease in SG&A was primarily due to a $3.0 million decrease in sales and marketing expenses, a $2.5 million decrease in consulting fees, a $0.7 million decrease in freight associated with lower sales, a $0.5 million decrease in sales commissions, a $0.4 million decrease in software implementation costs, and a $0.3 million decrease in facilities costs, partially offset by a $0.7 million increase in depreciation and amortization expenses. In the fourth quarter of 2023, we implemented measures targeting a decrease in operating expenses, including headcount reduction to lower global personnel costs.

Current wording

SG&A expense increased $10.8 million, or 37.4%, to $39.7 million for the three months ended March 31, 2025, compared to $28.9 million for the three months ended March 31, 2024. The increase in SG&A was primarily due to a $2.9 million increase in personnel and related costs, a $1.8 million increase in commissions, a $1.6 million increase in sales and marketing expenses, a $1.5 million increase in bad debt expense, a $1.0 million increase in facilities costs, a $0.9 million increase in depreciation and amortization expenses, a $0.8 million increase in freight associated with higher sales and a $0.4 million increase in insurance expenses, partially offset by a $0.9 million decrease in consulting fees.

Previous wording

R&D expense decreased $6.0 million, or 29.1%, to $14.6 million for the nine months ended September 30, 2024, compared to $20.6 million for the nine months ended September 30, 2023. The decrease in R&D expense was primarily due to a $5.9 million decrease in personnel cost.

Current wording

R&D expense increased $0.8 million, or 18.6%, to $5.1 million for the three months ended March 31, 2025, compared to $4.3 million for the three months ended March 31, 2024. The increase in R&D expense was primarily due to a $0.6 million increase in personnel cost and a $0.2 million increase in expenditures related to our IDE clinical trial in the United States.

Previous wording

Interest expense for the three months ended September 30, 2024 was $5.3 million as compared to $3.7 million for the three months ended September 30, 2023. The increase was primarily due to an increase in debt principal.

Current wording

Interest expense was $5.9 million for the three months ended March 31, 2025, compared to $4.4 million for the three months ended March 31, 2024. The increase was primarily due to an increase in debt principal.

Previous wording

Provision for income taxes decreased $0.2 million, or 28.6%, to $0.5 million for the three months ended September 30, 2024, compared to $0.7 million for the three months ended September 30, 2023. The change in the provision for income taxes is primarily due to the decrease in pre-tax income in certain U.S. and foreign jurisdictions.

Current wording

Provision for income taxes increased $0.5 million, or 125.0%, to $0.9 million for the three months ended March 31, 2025, compared to $0.4 million for the three months ended March 31, 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 $6.2 million to a gain of $2.0 million for the three months ended September 30, 2024, compared to a loss of $4.2 million for the three months ended September 30, 2023. 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 third quarter of 2024 compared to the third quarter of 2023, resulting in a foreign currency transaction gain of $2.2 million, the majority of which remains unrealized, for the three months ended September 30, 2024, compared to a $3.8 million loss for the three months ended September 30, 2023.

Current wording

Other income (expense), net increased $5.8 million to a gain of $2.8 million for the three months ended March 31, 2025, compared to a loss of $3.0 million for the three months ended March 31, 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 $2.8 million, the majority of which remains unrealized, for the three months ended March 31, 2025, compared to a $3.0 million loss for the three months ended March 31, 2024.

Previous wording

As of September 30, 2024, we had an accumulated deficit of $410.2 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, 2024 and December 31, 2023, we had cash of $39.7 million and $40.0 million, respectively.

Current wording

As of March 31, 2025, we had an accumulated deficit of $465.4 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, 2025 and December 31, 2024, we had cash of $69.2 million and $90.3 million, respectively.

Previous wording

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 5 “Debt” and Note 14 “Subsequent Events” for additional information.

Current wording

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.

Previous wording

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 closed on November 12, 2024 and will generate approximately $50 million in gross proceeds before offering expenses, 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 7 “Shareholders’ Equity” and Note 14 “Subsequent Events” for additional information.

Current wording

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 closed on November 12, 2024 and generated 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 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, 2023 under “Material Cash Requirements”, as updated below. Our long-term liquidity needs consist primarily of operating expenses, including 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. 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. 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.

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 $20.7 million for the three months ended March 31, 2025 was primarily comprised of a net loss of $20.7 million, changes in operating assets and liabilities of $5.2 million 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 operating activities of $80.4 million for the nine months ended September 30, 2023 was primarily comprised of a net loss of $58.0 million, changes in operating assets and liabilities of $44.8 million, $0.6 million of unrealized foreign currency gain and $3.0 million of interest capitalized for construction in progress, partially offset by $10.9 million of share-based compensation expense, $9.9 million of non-cash interest expense due to accretion of debt discounts, $2.9 million of non-cash depreciation and amortization expense, a $1.1 million change in provision for inventory obsolescence, and a $0.7 million change in allowance for doubtful accounts.

Current wording

Net cash used in operating activities of $11.2 million for the three months ended March 31, 2024 was primarily comprised of a net loss of $16.2 million, changes in operating assets and liabilities of $5.7 million, and $0.5 million of interest capitalized for construction in progress, partially offset by $3.4 million of non-cash interest expense due to accretion of debt discounts, $3.4 million of share-based compensation expense, $2.0 million of unrealized foreign currency loss, $1.3 million of non-cash depreciation and amortization expense, a $0.6 million change in provision for inventory obsolescence, and a $0.3 million change in allowance for credit losses.

Previous wording

Net cash used in investing activities of $13.8 million for the nine months ended September 30, 2024 primarily reflected $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.

Current wording

Net cash used in investing activities of $6.6 million for the three months ended March 31, 2024 primarily consisted $3.3 million in purchases of property and equipment primarily related to the new manufacturing facility, $1.9 million in purchases of intangibles primarily driven by the development of an enterprise resource planning system for our U.S. launch, and $1.4 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 $86.2 million for the nine months ended September 30, 2023 primarily $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 $2.1 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 $0.2 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

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 $51.0 million for the three months ended March 31, 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 $1.4 million in proceeds received for stock option exercises partially offset by $0.1 million paid to satisfy tax withholding obligations upon the vesting of restricted stock.

Previous wording

Except as described above with respect to the advancement of the Tranche C Term Loan, our material cash requirements have not changed materially from those included in our Annual Report on the Form 10-K filed with the SEC on March 4, 2024.

Current 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.

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. 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. As of September 30, 2024, $196.4 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 and $21.4 million of interest accrued into the principal balance.

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 will depend on our ability to satisfy the gross sales thresholds required to advance the tranches by the dates specified.

Previous wording

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. The Tranche C Term Loan of $25 million was advanced in October 2024. See “Liquidity and Capital Resources” above and Note 5 “Debt” and Note 14 “Subsequent Events” for additional information. 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

See “Liquidity and Capital Resources” above and Note 6 “Debt” for additional information.