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ESTABLISHMENT LABS HOLDINGS INC.

For the period ended Sep 30, 2026. Filed Nov 6, 2026.

View on SEC.gov

About this filing

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.

Sep 30, 2026 · Filed Nov 6, 2026

ESTA$67.02+4.0%Stored close · as of Nov 6, 2026

What changed in Management’s Discussion and Analysis?

Read the current filing

Previous report: 10-Q

Period ended 2026-06-30; filed 2026-08-07.

0001688757-26-000050

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Current report: 10-Q

Period ended 2026-09-30; filed 2026-11-06.

0001688757-26-000062

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The 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 82 previous paragraphs and 83 current paragraphs.

54 unchanged; 25 reworded; 4 added; 1 removed; 2 previous and 0 current paragraphs rearranged.

Tables are not compared: 6 previous and 6 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 (4)

Current report

On October 14, 2026, the Company announced a new supply agreement with its sole medical-grade silicone supplier, NuSil Technology LLC, to support long-term manufacturing capacity and future growth.

Current report

On the October 5, 2026, the Company announced it received U.S. Food and Drug Administration (“FDA”) approval for additional smaller Motiva implant sizes, expanding the range of options available to U.S. surgeons and patients.

Current report

Gross margin decreased to 69.1% for the three months ended September 30, 2026 as compared to 70.1% for the three months ended September 30, 2025. The decrease was primarily attributable to inventory charges associated with restructuring activities and a higher mix of lower margin distributor sales outside of the United States, and both partially offset by continued growth in the United States and the related revenue from our minimally invasive product portfolio.
Removed paragraphs (1)
Reworded paragraphs (25)

Previous wording

Our revenue for the six months ended June 30, 2026 and 2025 was $127.4 million and $92.7 million, respectively, an increase of $34.7 million, or 37.5%. Net losses were $25.1 million for the six months ended June 30, 2026 as compared to $37.3 million for the six months ended June 30, 2025. As of June 30, 2026, we had an accumulated deficit of $520.9 million.

Current wording

Our revenue for the nine months ended September 30, 2026 and 2025 was $199.4 million and $146.5 million, respectively, an increase of $53.0 million, or 36.2%. Net losses were $35.8 million for the nine months ended September 30, 2026 as compared to $48.4 million for the nine months ended September 30, 2025. As of September 30, 2026, we had an accumulated deficit of $531.6 million.

Previous wording

Revenue increased $16.2 million, or 31.7%, to $67.5 million for the three months ended June 30, 2026 as compared to $51.3 million for the three months ended June 30, 2025. The increase was primarily due to a $14.4 million increase in sales in the United States and a $1.8 million increase in sales outside of the United States.

Current wording

Revenue increased $18.2 million, or 33.9%, to $72.0 million for the three months ended September 30, 2026 as compared to $53.8 million for the three months ended September 30, 2025. The increase was primarily due to a $14.2 million increase in sales in the United States and a $4.1 million increase in sales outside of the United States.

Previous wording

Cost of revenue increased $3.8 million, or 23.7%, for the three months ended June 30, 2026 compared to the three months ended June 30, 2025. The increase in cost of revenue was generally consistent with the increase in revenue, except as described below.

Current wording

Cost of revenue increased $6.2 million, or 38.5%, for the three months ended September 30, 2026 compared to the three months ended September 30, 2025. The increase in cost of revenue was generally consistent with the increase in revenue, except as described below.

Previous wording

Sales, general and administrative, or SG&A, expense increased $2.7 million, or 6.2%, to $46.9 million for the three months ended June 30, 2026, compared to $44.2 million for the three months ended June 30, 2025. The increase in SG&A was primarily due to a $1.9 million increase in professional fees associated with the Amended Credit Agreement, a $0.9 million increase in consulting fees and a $0.9 million increase in sales commissions associated with higher revenue partially offset by a $2.0 million decrease in sales and marketing expense.

Current wording

Sales, general and administrative, or SG&A, expense increased $10.9 million, or 29.2%, to $48.0 million for the three months ended September 30, 2026, compared to $37.2 million for the three months ended September 30, 2025. The increase in SG&A was primarily due to a $3.7 million increase in personnel costs, a $2.5 million increase in freight costs associated with higher revenue, a $1.8 million increase in sales and marketing expense, a $1.4 million increase in sales commissions associated with higher revenues, $1.5 million in restructuring activities and a $0.9 million increase in legal fees related to litigation matters, partially offset by a $0.7 million decrease in bad debt expense.

Previous wording

Research and development, or R&D, expense was relatively consistent at $5.1 million for the three months ended June 30, 2026, compared to $5.2 million for the three months ended June 30, 2025.

Current wording

Research and development, or R&D, expense was relatively consistent at $4.3 million for the three months ended September 30, 2026, compared to $4.6 million for the three months ended September 30, 2025.

Previous wording

Interest expense for the three months ended June 30, 2026 was $7.0 million as compared to $6.0 million for the three months ended June 30, 2025. The increase was primarily due to an increase in debt associated with the Amended Credit Agreement.

Current wording

Interest expense for the three months ended September 30, 2026 was $6.8 million as compared to $6.2 million for the three months ended September 30, 2025. The increase was primarily due to an increase in debt associated with the Amended Credit Agreement.

Previous wording

Provision for income taxes decreased $1.0 million, or 99.4%, to $6 thousand for the three months ended June 30, 2026, compared to $1.0 million for the three months ended June 30, 2025. 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 $0.2 million, or 44.3%, to $612 thousand for the three months ended September 30, 2026, compared to $0.4 million for the three months ended September 30, 2025. The change in the provision for income taxes is primarily due to the increase in pre-tax income in certain U.S. and foreign jurisdictions.

Previous wording

Other (income) expense, net, changed $4.9 million to a loss of $0.4 million for the three months ended June 30, 2026, compared to an income of $4.5 million for the three months ended June 30, 2025. The change 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 2026 compared to the second quarter of 2025, resulting in a foreign currency transaction loss of $0.7 million for the three months ended June 30, 2026, the majority of which remains unrealized, compared to $5.0 million of income for the three months ended June 30, 2025. Interest income decreased $0.1 million.

Current wording

Other (income) expense, net, changed $0.2 million to a loss of $0.7 million for the three months ended September 30, 2026, compared to a loss of $0.5 million for the three months ended September 30, 2025. The change 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 2026 compared to the third quarter of 2025, resulting in a foreign currency transaction loss of $0.3 million for the three months ended September 30, 2026, the majority of which remains unrealized, compared to $0.4 million of loss for the three months ended September 30, 2025. Interest income was consistent period over period.

Previous wording

Revenue increased $34.7 million, or 37.5%, to $127.4 million for the six months ended June 30, 2026 as compared to $92.7 million for the six months ended June 30, 2025. The increase was primarily due to a $27.9 million increase in sales in the United States and a $6.8 million increase in sales outside of the United States.

Current wording

Revenue increased $53.0 million, or 36.2%, to $199.4 million for the nine months ended September 30, 2026 as compared to $146.5 million for the nine months ended September 30, 2025. The increase was primarily due to a $42.1 million increase in sales in the United States and a $10.9 million increase in sales outside of the United States.

Previous wording

Cost of revenue increased $7.8 million, or 26.3%, to $37.4 million for the six months ended June 30, 2026 compared to $29.6 million for the six months ended June 30, 2025. The increase in cost of revenue was primarily driven by higher revenue.

Current wording

Cost of revenue increased $14.0 million, or 30.6%, to $59.7 million for the nine months ended September 30, 2026 compared to $45.7 million for the nine months ended September 30, 2025. The increase in cost of revenue was primarily driven by higher revenue.

Previous wording

Gross margin increased to 70.7% for the six months ended June 30, 2026 compared to 68.1% for the six months ended June 30, 2025. The increase was primarily attributable to a more favorable geographic sales mix, driven by higher selling prices on sales within the United States, direct market expansion outside the United States and increased revenue from our minimally invasive product portfolio partially offset by an increase in inventory obsolescence reserve.

Current wording

Gross margin increased to 70.1% for the nine months ended September 30, 2026 compared to 68.8% for the nine months ended September 30, 2025. The increase was primarily attributable to a more favorable geographic sales mix, driven by higher selling prices on sales within the United States, direct market expansion outside the United States and increased revenue from our minimally invasive product portfolio partially offset by an increase in inventory charges related to restructuring activities.

Previous wording

SG&A expense increased $6.6 million, or 7.9%, to $90.5 million for the six months ended June 30, 2026, compared to $83.9 million for the six months ended June 30, 2025. The increase in SG&A was primarily due to a $1.9 million increase in professional fees associated with the Amended Credit Agreement, a $1.2 million increase in sales commissions associated with higher revenue, a $2.0 million increase in professional fees, a $4.0 million increase in personnel costs, and a $1.3 million increase in freight costs associated with higher revenue partially offset by a $3.2 million decrease in sales and marketing expense and a $1.9 million decrease in bad debt expense.

Current wording

SG&A expense increased $17.5 million, or 14.5%, to $138.5 million for the nine months ended September 30, 2026, compared to $121.0 million for the nine months ended September 30, 2025. The increase in SG&A was primarily due to a $1.9 million increase in professional fees associated with the Amended Credit Agreement, a $2.5 million increase in sales commissions associated with higher revenue, a $3.0 million increase in legal fees related to litigation matters, a $7.6 million increase in personnel costs, $1.5 million in restructuring activities and a $3.7 million increase in freight costs associated with higher revenues, partially offset by a $1.5 million decrease in sales and marketing expense and a $2.6 million decrease in bad debt expense.

Previous wording

R&D expense remained consistent at $10.3 million for the six months ended June 30, 2026, compared to $10.3 million for the six months ended June 30, 2025.

Current wording

R&D expense remained consistent at $14.7 million for the nine months ended September 30, 2026, compared to $14.8 million for the nine months ended September 30, 2025.

Previous wording

Interest expense was $14.1 million for the six months ended June 30, 2026, compared to $11.8 million for the six months ended June 30, 2025. The increase was primarily due to an increase in debt associated with the Amended Credit Agreement.

Current wording

Interest expense was $20.9 million for the nine months ended September 30, 2026, compared to $18.0 million for the nine months ended September 30, 2025. The increase was primarily due to an increase in debt associated with the Amended Credit Agreement.

Previous wording

Provision for income taxes decreased $1.6 million, or 84.7%, to $0.3 million for the six months ended June 30, 2026, compared to $1.9 million for the six months ended June 30, 2025. The change in the provision for income taxes is primarily due to a decrease in pre-tax income in certain foreign jurisdictions.

Current wording

Provision for income taxes decreased $1.4 million, or 61.3%, to $0.9 million for the nine months ended September 30, 2026, compared to $2.3 million for the nine months ended September 30, 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 $7.4 million to an income of $0.1 million for the six months ended June 30, 2026, compared to an income of $7.5 million for the six months ended June 30, 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 $1.0 million, the majority of which remains unrealized, for the six months ended June 30, 2026, compared to $7.8 million of income for the six months ended June 30, 2025. Interest income decreased $0.3 million.

Current wording

Other (income) expense, net decreased $7.6 million to a loss of $0.6 million for the nine months ended September 30, 2026, compared to an income of $7.0 million for the nine months ended September 30, 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 $1.3 million, the majority of which remains unrealized, for the nine months ended September 30, 2026, compared to $7.4 million of income for the nine months ended September 30, 2025. Interest income decreased $0.3 million.

Previous wording

As of June 30, 2026, we had an accumulated deficit of $520.9 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, marketing and distributor infrastructure, most recently in the United States, investing in inventory, R&D activities, asset acquisitions, capital improvements, including the expansion of our manufacturing facilities, and other working capital needs. As of June 30, 2026 and December 31, 2025, we had cash of $71.2 million and $75.6 million, respectively.

Current wording

As of September 30, 2026, we had an accumulated deficit of $531.6 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, marketing and distributor infrastructure, most recently in the United States, investing in inventory, R&D activities, asset acquisitions, capital improvements, including the expansion of our manufacturing facilities, and other working capital needs. As of September 30, 2026 and December 31, 2025, we had cash of $75.8 million and $75.6 million, respectively.

Previous 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 New 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.

Current wording

Per our Amended Credit Agreement, we must maintain a minimum liquidity of $30 million at all times, and our short-term liquidity requirements consist primarily of operating expenses and interest payments on the Amended Credit Agreement and other short-term borrowings. 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 New 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

Net cash used in operating activities of $20.9 million for the six months ended June 30, 2026 was primarily comprised of a net loss of $25.1 million and a $15.7 million change in operating assets and liabilities, partially offset by $6.2 million of share-based compensation expense, $5.7 million of non-cash interest expense due to accretion of debt discounts, $4.9 million of non-cash depreciation and amortization expense, $2.7 million of unrealized foreign currency loss, and $0.5 million of right-of-use asset amortization.

Current wording

Net cash used in operating activities of $13.2 million for the nine months ended September 30, 2026 was primarily comprised of a net loss of $35.8 million and a $10.2 million change in operating assets and liabilities, partially offset by $9.2 million of share-based compensation expense, $11.8 million of non-cash interest expense due to accretion of debt discounts, $7.3 million of non-cash depreciation and amortization expense, $3.6 million of unrealized foreign currency loss, and $0.7 million of right-of-use asset amortization.

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, $7.7 million change in operating assets and liabilities, 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, a $0.5 million loss on contract termination, $0.5 million of right-of-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, $14.7 million change in operating assets and liabilities, 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, $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 investing activities of $5.6 million for the six months ended June 30, 2026 primarily reflected $5.5 million in purchases of property and equipment at our Costa Rican entity.

Current wording

Net cash used in investing activities of $8.2 million for the nine months ended September 30, 2026 primarily reflected $6.4 million in purchases of property and equipment at our Costa Rican entity.

Previous wording

Net cash used in investing activities of $3.4 million for the six months ended June 30, 2025 primarily consisted of $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 B.V. and Motiva NL B.V..

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 provided by financing activities of $22.6 million for the six months ended June 30, 2026 primarily reflected a $265.0 million in borrowings under the Amended Credit Agreement and $16.9 million in proceeds received for stock option exercises, partially offset by $246.4 million used to repay borrowings under the previous Credit Agreement, $10.0 million used for debt discount and debt issuance costs, a $2.0 million repayment of short-term notes payable for insurance premium financing and $1.0 million paid to satisfy tax withholding obligations upon the vesting of restricted stock.

Current wording

Net cash provided by financing activities of $22.5 million for the nine months ended September 30, 2026 primarily reflected a $265.0 million in borrowings under the Amended Credit Agreement and $17.5 million in proceeds received for stock option exercises, partially offset by $246.4 million used to repay borrowings under the previous Credit Agreement, $10.0 million used for debt discount and debt issuance costs, a $2.5 million repayment of short-term notes payable for insurance premium financing and $1.2 million paid to satisfy tax withholding obligations upon the vesting of restricted stock.

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.
Rearranged previous paragraphs (2)

Previous report — wording carried elsewhere

Gross margin increased to 70.6% for the three months ended June 30, 2026 as compared to 68.8% for the three months ended June 30, 2025. The increase was primarily attributable to a more favorable geographic sales mix, driven by higher selling prices on sales within the United States, direct market expansion outside the United

Previous report — wording carried elsewhere

States and increased revenue from our minimally invasive product portfolio partially offset by an increase in inventory obsolescence reserve.