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Item 2 — Management's Discussion and Analysis
Establishment Labs Holdings Inc. · 10-Q · Q2 FY2026 · Period ended Jun 30, 2026
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You should read the following discussion and analysis of our financial condition and results of operations together with the condensed consolidated financial statements and related notes that are included elsewhere in this Quarterly Report on Form 10-Q. This discussion contains forward-looking statements based upon current expectations that involve risks and uncertainties. Our actual results may differ materially from those anticipated in these forward-looking statements as a result of various factors, including those set forth under “Risk Factors,” in Part I, Item 1A. of our Form 10-K filed with the Securities and Exchange Commission, or SEC, on February 27, 2026. See “Special Note Regarding Forward-Looking Statements” above.
Overview
Our line of silicone gel-filled breast implants, branded as Motiva Implants, is the centerpiece of our medical technology platform. Our 5-year results from our Motiva U.S. IDE study as well as our patient and practitioner reported post-market surveillance data indicate that Motiva Implants have low rates of adverse events (including rupture, capsular contracture, and implant-related reoperations) that compare favorably with those of our competitors. We believe these proprietary technologies that differentiate our Motiva Implants result in improved safety and aesthetic outcomes and thus drive our revenue growth.
We have devoted a majority of our resources since inception to developing our Motiva Implants, which we began selling in October 2010. We have incurred net losses in each year since inception, and we have financed our operations primarily through equity financings and debt financings.
In September 2024, we received FDA approval to sell Motiva Implants in the United States.
Recent Developments
Regulatory and Operational Updates
On June 29, 2026, the Company announced the appointment of Taylor Harris to its Board of Directors.
On February 24, 2026, the Company announced the appointment of Cassandra “Sandra” Harris to Senior Vice President and Chief Financial Officer, effective March 9, 2026, to succeed Raj Denhoy, the then-current Chief Financial Officer.
Financing Activities
On June 25, 2026, the Company was added as a member of the U.S. small-cap Russell 2000 Index as part of the 2026 Russell indexes reconstitution.
On April 30, 2026, the Company entered into an Amended and Restated Credit Agreement and Guaranty, or the Amended Credit Agreement, together with certain of our subsidiaries as guarantors, the lenders from time to time party thereto, or the Lenders, and Oaktree Fund Administration, LLC, as administrative agent for the Lenders, pursuant to which the Lenders agreed to make term loans to the Company in an aggregate principal amount of up to $300 million. The first tranche was advanced in the amount of $265 million on April 30, 2026. Approximately $259 million of the proceeds from the Tranche E Term Loan was used to repay in full the obligations under the Credit Agreement and transaction costs in connection with the New Term Loans. See Note 4 “Debt” for additional information.
Financial Highlights
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.
Our cash balance as of June 30, 2026 was $71.2 million.
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Critical Accounting Policies, Significant Judgments and Use of Estimates
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, 2025 included in our Annual Report on Form 10-K filed with the SEC on February 27, 2026, 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 our Form 10-K filed with the SEC on February 27, 2026.
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Consolidated Results of Operations
The following table sets forth our results of operations for the periods presented, in dollars:
Three Months Ended June 30, Six Months Ended June 30,
2026 2025 2026 2025
(unaudited) (in thousands)
Revenue $ 67,542 $ 51,300 $ 127,419 $ 92,677
Cost of revenue 19,831 16,028 37,373 29,597
Gross profit 47,711 35,272 90,046 63,080
Operating expenses:
Sales, general and administrative 46,905 44,176 90,510 83,875
Research and development 5,096 5,203 10,337 10,258
Total operating expenses 52,001 49,379 100,847 94,133
Loss from operations (4,290) (14,107) (10,801) (31,053)
Interest expense 7,034 5,956 14,122 11,809
Other (income) loss, net 418 (4,474) (87) (7,477)
Loss before income taxes (11,742) (15,589) (24,836) (35,385)
Provision for income taxes 6 1,004 294 1,918
Net loss $ (11,748) $ (16,593) $ (25,130) $ (37,303)
Comparison of Three Months Ended June 30, 2026 and 2025
Three Months Ended June 30,
2026 2025
(unaudited) (in thousands)
Revenue $ 67,542 $ 51,300
Cost of revenue 19,831 16,028
Gross profit $ 47,711 $ 35,272
Gross margin 70.6 % 68.8 %
Revenue
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.
Cost of Revenue and Gross Margin
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.
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
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States and increased revenue from our minimally invasive product portfolio partially offset by an increase in inventory obsolescence reserve.
Operating Expenses
Three Months Ended June 30,
2026 2025
(unaudited) (in thousands)
Sales, general and administrative $ 46,905 $ 44,176
Research and development 5,096 5,203
Total operating expenses $ 52,001 $ 49,379
Sales, General and Administrative Expense
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.
Research and Development Expense
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.
Interest Expense
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.
Provision for Income Taxes
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.
Other (Income) Expense, Net
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.
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Comparison of Six Months Ended June 30, 2026 and 2025
Six Months Ended June 30,
2026 2025
(unaudited) (in thousands)
Revenue $ 127,419 $ 92,677
Cost of revenue 37,373 29,597
Gross profit $ 90,046 $ 63,080
Gross margin 70.7 % 68.1 %
Revenue
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.
Cost of Revenue and Gross Margin
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.
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.
Operating Expenses
Six Months Ended June 30,
2026 2025
(unaudited) (in thousands)
Sales, general and administrative $ 90,510 $ 83,875
Research and development 10,337 10,258
Total operating expenses $ 100,847 $ 94,133
Sales, General and Administrative Expense
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.
Research and Development Expense
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.
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Interest Expense
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.
Provision for Income Taxes
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.
Other (Income) Expense, Net
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.
Liquidity and Capital Resources
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.
In April 2026, we entered into the Amended Credit Agreement, which provided for new term loans in an aggregate principal amount of up to $300 million. The first tranche was advanced in the amount of $265 million on April 30, 2026. Approximately $259 million of the proceeds from the Tranche E Term Loan was used to repay in full outstanding obligations under the Credit Agreement and transaction costs in connection with the New Term Loans. See Note 4 “Debt” for additional information regarding the Amended Credit Agreement.
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.
Our future capital requirements will depend on many factors, including:
▪the degree and rate of market adoption of our products;
▪the cost and timing of our regulatory activities;
▪the emergence of new competing technologies and products;
▪the costs of R&D activities we undertake to develop and expand our products;
▪the costs of commercialization activities, including sales, marketing and manufacturing;
▪the level of working capital required to support our growth; and
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▪our need for additional personnel, information technology or other operating infrastructure to support our growth and operations as a public company.
Cash Flows
The following table sets forth the primary sources and uses of cash for each of the periods presented below:
Six Months Ended June 30,
2026 2025
(unaudited) (in thousands)
Net cash provided by (used in):
Operating activities $ (20,912) $ (39,478)
Investing activities (5,609) (3,407)
Financing activities 22,599 4,926
Effect of exchange rate changes on cash (493) 2,251
Net decrease in cash $ (4,415) $ (35,708)
Net Cash Used in Operating Activities
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.
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.
Net Cash Used in Investing Activities
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.
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..
Net Cash Provided by Financing Activities
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.
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
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the vesting of restricted stock.
Material Cash Requirements
Other than as described above with respect to the Amended Credit Agreement, our material cash requirements have not changed materially from those included in our Annual Report on Form 10-K filed with the SEC on February 27, 2026.
Recent Accounting Pronouncements
Please refer to Note 2 “Summary of Significant Accounting Policies” in this Form 10-Q for information on recent accounting pronouncements and the expected impact on our unaudited condensed consolidated financial statements.