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ESTA

Establishment LabsF
Nasdaq / Health Care Equipment & Services
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2026-08-06
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Earnings documents stored for ESTA.

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Investor releaseQuarter not tagged2026-08-06

Establishment Labs Q2 Earnings Call Highlights

MarketBeat
Interested in Establishment Labs Holdings Inc.? Here are five stocks we like better. Strong growth and raised outlook: Second-quarter revenue rose 31.7% year over year to $67.5 million, while adjusted EBITDA improved to positive $3.7 million from a loss of $8.5 million. Establishment Labs raised its full-year revenue forecast to $269 million–$271 million. U.S. and Minimally Invasive platforms drive momentum: U.S. revenue surged 140.9% to $24.7 million, with more than 100,000 Motiva implants sold and over 2,000 accounts. Mia and Preservé generated $12.1 million in quarterly revenue, while Preservé exceeded surgeon-training expectations and commands a significant pricing premium. Improving financial position and future pipeline: Gross margin increased to 70.6%, cash reached $71.2 million, and management said no future equity raises are needed to execute its strategy. The company expects to become free-cash-flow positive in the second half of 2026, while reconstruction revenue is expected from 2027 and GEM could contribute in the U.S. from 2028 or later. Establishment Labs (NASDAQ:ESTA) reported second-quarter revenue growth of 31.7% year over year, driven by continued rapid expansion in the United States, rising adoption of its Minimally Invasive platform and improving operating leverage. Revenue for the quarter totaled $67.5 million, while adjusted EBITDA was positive $3.7 million, compared with an adjusted EBITDA loss of $8.5 million in the prior-year period. The company raised its full-year revenue outlook to a range of $269 million to $271 million, from prior guidance of $266.5 million to $268.5 million. → 3 Drone Stocks That Should Soar After the Summer Slump CEO Peter Caldini said the company had started the third quarter well despite the period traditionally being the seasonal low point for breast augmentation procedures. Establishment Labs expects to transition to free-cash-flow positive in the second half of 2026 and to remain free-cash-flow positive for fiscal 2027. U.S. revenue increased 140.9% from a year earlier to $24.7 million, representing 36.6% of total company revenue, compared with 20% a year earlier. U.S. revenue also rose 26% sequentially from the first quarter, according to Caldini. → Meta’s Earnings Drop Shows Wall Street Wants More Than Ad Growth The company said it surpassed 100,000 Motiva implants in the U.S. market less than 21 month…Read full document

Interested in Establishment Labs Holdings Inc.? Here are five stocks we like better. Strong growth and raised outlook: Second-quarter revenue rose 31.7% year over year to $67.5 million, while adjusted EBITDA improved to positive $3.7 million from a loss of $8.5 million. Establishment Labs raised its full-year revenue forecast to $269 million–$271 million. U.S. and Minimally Invasive platforms drive momentum: U.S. revenue surged 140.9% to $24.7 million, with more than 100,000 Motiva implants sold and over 2,000 accounts. Mia and Preservé generated $12.1 million in quarterly revenue, while Preservé exceeded surgeon-training expectations and commands a significant pricing premium. Improving financial position and future pipeline: Gross margin increased to 70.6%, cash reached $71.2 million, and management said no future equity raises are needed to execute its strategy. The company expects to become free-cash-flow positive in the second half of 2026, while reconstruction revenue is expected from 2027 and GEM could contribute in the U.S. from 2028 or later. Establishment Labs (NASDAQ:ESTA) reported second-quarter revenue growth of 31.7% year over year, driven by continued rapid expansion in the United States, rising adoption of its Minimally Invasive platform and improving operating leverage. Revenue for the quarter totaled $67.5 million, while adjusted EBITDA was positive $3.7 million, compared with an adjusted EBITDA loss of $8.5 million in the prior-year period. The company raised its full-year revenue outlook to a range of $269 million to $271 million, from prior guidance of $266.5 million to $268.5 million. → 3 Drone Stocks That Should Soar After the Summer Slump CEO Peter Caldini said the company had started the third quarter well despite the period traditionally being the seasonal low point for breast augmentation procedures. Establishment Labs expects to transition to free-cash-flow positive in the second half of 2026 and to remain free-cash-flow positive for fiscal 2027. U.S. revenue increased 140.9% from a year earlier to $24.7 million, representing 36.6% of total company revenue, compared with 20% a year earlier. U.S. revenue also rose 26% sequentially from the first quarter, according to Caldini. → Meta’s Earnings Drop Shows Wall Street Wants More Than Ad Growth The company said it surpassed 100,000 Motiva implants in the U.S. market less than 21 months after launch. It also ended the quarter with more than 2,000 U.S. accounts, with many accounts using Motiva across multiple surgeons. Caldini said growth is increasingly coming from greater use within existing accounts as surgeons become more familiar with the product’s clinical data, patient outcomes and differentiators. He added that management is seeing growing patient awareness of the Motiva brand, citing company feedback that 75% of surgeons report patients asking for an implant brand and, in 93% of those instances, the requested brand is Motiva. → Jersey Mike's Serves Fresh Gains After IPO Stumble Outside the U.S., revenue was $42.8 million, up 4.4% year over year. Europe grew 16%, led by Italy, Germany and the U.K., while Argentina continued its positive trajectory and Brazil remained stable, management said. Caldini said demand in most distributor markets remained steady, though Middle East orders were below historical levels amid regional conflict. CFO Sandra Harris said the Middle East accounts for less than 5% of company revenue. Establishment Labs generated $12.1 million in quarterly revenue from its Minimally Invasive platform, which includes the Mia and Preservé procedures. Management said the platform is approaching 15% of full-year global revenue and is performing above its original expectations. Mia is currently offered outside the U.S. and is intended for women seeking a more subtle enhancement. Preservé, which is being rolled out in the U.S., is designed to accommodate a broader range of patient needs, including larger augmentations and augmentation mastopexy procedures, while retaining the company’s tissue-preserving approach. Caldini said Preservé had more than 300 trained and certified surgeons at the end of the quarter, exceeding the company’s original full-year expectation by more than 50%. Establishment Labs now expects to train about 500 surgeons during 2026. Management said surgeons are generally charging 30% to 50% more for Preservé than for traditional breast augmentations. Caldini also said Preservé commands a premium of more than two times that of a traditional breast augmentation procedure for Establishment Labs in the U.S. The company said its research indicates that 15% of women undergoing Preservé had not initially been considering breast augmentation. Caldini said Minimally Invasive procedures can address barriers including anesthesia, scarring and recovery time, potentially attracting patients who may not otherwise have pursued augmentation. Gross profit was $47.7 million, or 70.6% of revenue, compared with a 68.8% gross margin in the prior-year quarter. Harris attributed the margin improvement to a greater contribution from higher-margin U.S. and direct international markets, favorable product mix and growth in the Minimally Invasive platform. Operating expenses were reported at $52 million for the quarter, including one-time costs, while management said expenses increased modestly relative to nearly 32% revenue growth. Harris said the company has been able to leverage operating spending and does not anticipate major increases beyond its prior investment levels as it advances its innovation pipeline. Cash and cash equivalents totaled $71.2 million at quarter-end, up $3.1 million from the first quarter and $16.5 million from a year earlier. Harris said the company generated positive overall cash flow and has sufficient liquidity to execute its strategy without future equity raises. For the third quarter, management cautioned that the business is subject to normal seasonal softness during summer vacation periods. The fourth quarter is expected to be the company’s strongest quarter of the year. Establishment Labs continues to advance its U.S. reconstruction submission with the Food and Drug Administration, expand its U.S. implant size matrix and develop GEM, a potential gluteal augmentation procedure. Caldini said the FDA has begun BIMO audits of clinical study sites for the reconstruction submission, while the company is responding to what it considers routine agency questions. Management does not expect material reconstruction revenue until 2027. The company said it expects revenue growth of around 25% in 2027, though it did not provide more detailed guidance for that year. For GEM, Caldini said Establishment Labs is conducting a clinical study in Costa Rica and expects an early experience in Latin America during the second half of 2027. The company is still evaluating regulatory pathways in the U.S. and Europe and does not expect GEM to contribute materially in the U.S. until 2028 or later. Establishment Labs Holdings Inc is a global medical technology company specializing in the design, development and manufacture of silicone gel breast implants for aesthetic and reconstructive surgery. The company's proprietary portfolio is built around patient-focused safety, customization and innovation, offering solutions intended to enhance surgical outcomes and support clinical traceability. The company's flagship products fall under the Motiva® brand, which includes a range of ergonomic and round breast implants featuring SilkSurface® texturing and an embedded Q Inside® Safety microtransponder for unique implant identification. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Establishment Labs Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.

Investor releaseQuarter not tagged2026-08-06

Establishment Labs® Reports Second Quarter 2026 Financial Results

Business Wire
NEW YORK, August 06, 2026--(BUSINESS WIRE)--Establishment Labs Holdings Inc. (NASDAQ: ESTA), a global medical technology company dedicated to improving women’s health and wellness, principally in breast aesthetics and reconstruction, today announced financial results for the second quarter ended June 30, 2026. Second Quarter Highlights and Outlook (Unaudited) Revenue of $67.5 million, up 31.7% from Q2 2025, and sequential growth of 12.8% from Q1 2026 $24.7 million of sales in the United States, up 26% from Q1 2026 Guidance raised to $269 million to $271 million, an increase from previous guidance of $266.5 million to $268.5 million Minimally invasive revenue of $12.1 million for the quarter Gross margin of 70.6% compared to 68.8% in the year-ago period Loss from operations was $4.3 million compared to a loss of $14.1 million in the year-ago period Adjusted EBITDA income of $3.7 million compared to a loss of $8.5 million in the year-ago period Cash balance of $71.2 million as of June 30, 2026, a $16.5 million improvement from the year-ago period, and up $3.1 million from Q1 2026 "Momentum continued throughout the second quarter and into the third quarter as we continue to take market share and expand the category," said Peter Caldini, Chief Executive Officer. "Strong execution globally, accelerating adoption of our minimally invasive platform, and expanding profitability allows us to raise our full-year revenue guidance. We should have strong growth in the second half of 2026 and throughout 2027, as our business inflects to be both high growth and free cash flow positive." Second Quarter 2026 Financial Results (Unaudited) Total revenue for the quarter ended June 30, 2026 was $67.5 million, compared to $51.3 million for the same period in 2025, representing a growth of 31.7%, with Motiva USA revenue increasing to $24.7 million from $10.3 million in the prior-year period. Gross profit for the second quarter of $47.7 million, or 70.6% of revenue, increased compared to $35.3 million, or 68.8% of revenue, for the same period in 2025. The improvement in gross profit margin was primarily driven by favorable geographic and channel mix, including continued growth of our higher-margin U.S. business and our minimally invasive platform. Total operating expenses for the second quarter were $52.0 million compared to $49.4 million in the second quarter of 2025. Total operat…Read full document

NEW YORK, August 06, 2026--(BUSINESS WIRE)--Establishment Labs Holdings Inc. (NASDAQ: ESTA), a global medical technology company dedicated to improving women’s health and wellness, principally in breast aesthetics and reconstruction, today announced financial results for the second quarter ended June 30, 2026. Second Quarter Highlights and Outlook (Unaudited) Revenue of $67.5 million, up 31.7% from Q2 2025, and sequential growth of 12.8% from Q1 2026 $24.7 million of sales in the United States, up 26% from Q1 2026 Guidance raised to $269 million to $271 million, an increase from previous guidance of $266.5 million to $268.5 million Minimally invasive revenue of $12.1 million for the quarter Gross margin of 70.6% compared to 68.8% in the year-ago period Loss from operations was $4.3 million compared to a loss of $14.1 million in the year-ago period Adjusted EBITDA income of $3.7 million compared to a loss of $8.5 million in the year-ago period Cash balance of $71.2 million as of June 30, 2026, a $16.5 million improvement from the year-ago period, and up $3.1 million from Q1 2026 "Momentum continued throughout the second quarter and into the third quarter as we continue to take market share and expand the category," said Peter Caldini, Chief Executive Officer. "Strong execution globally, accelerating adoption of our minimally invasive platform, and expanding profitability allows us to raise our full-year revenue guidance. We should have strong growth in the second half of 2026 and throughout 2027, as our business inflects to be both high growth and free cash flow positive." Second Quarter 2026 Financial Results (Unaudited) Total revenue for the quarter ended June 30, 2026 was $67.5 million, compared to $51.3 million for the same period in 2025, representing a growth of 31.7%, with Motiva USA revenue increasing to $24.7 million from $10.3 million in the prior-year period. Gross profit for the second quarter of $47.7 million, or 70.6% of revenue, increased compared to $35.3 million, or 68.8% of revenue, for the same period in 2025. The improvement in gross profit margin was primarily driven by favorable geographic and channel mix, including continued growth of our higher-margin U.S. business and our minimally invasive platform. Total operating expenses for the second quarter were $52.0 million compared to $49.4 million in the second quarter of 2025. Total operating expenses included one-time charges related to debt refinancing and restructuring costs of $2.2 million in the second quarter of 2026 and $0.5 million in the same period last year. Excluding these one-time charges, adjusted operating expenses increased 2.0% compared to a revenue growth of 31.7%, demonstrating the operating leverage we are achieving as the business continues to scale. Net loss for the second quarter was $11.7 million, compared to a net loss of $16.6 million in the year-ago period. Adjusted EBITDA increased by $12.2 million to an income of $3.7 million compared to a loss of $8.5 million in the year-ago period, achieving another quarter of positive adjusted EBITDA. The Company’s cash balance on June 30, 2026 was $71.2 million. Conference Call and Webcast Information Establishment Labs will host a conference call and webcast today at 8:30 a.m. Eastern Time to discuss its financial results. To participate in the conference call, Dial: (+1) 888-396-8049 (US & Canada) / (+1) 416-764-8646 (international). The call will also be available via live or archived webcast on the "Investor Relations" section of the Establishment Labs website at www.establishmentlabs.com. About Establishment Labs Establishment Labs Holdings Inc. is a global medical device company dedicated to improving women’s health and wellness in breast aesthetics and reconstruction through the power of science, engineering, and technology. The company offers a portfolio of solutions for breast health, breast aesthetics, and breast reconstruction in over 100 countries. With five million Motiva® devices delivered to plastic and reconstructive surgeons since 2010, the company’s products have created a new standard for safety and patient satisfaction. The company’s minimally invasive platform consists of Mia Femtech®, a unique minimally invasive experience for breast harmonization, and Preservé™, a breast tissue preserving and minimally invasive technology for primary breast augmentation and primary mastopexy augmentation. GEM® is a next generation minimally invasive system for gluteal ergonomic modeling currently undergoing an IRB approved pivotal study. The Motiva Flora® tissue expander is used to improve outcomes in breast reconstruction following breast cancer and is the only regulatory-approved expander in the world with an integrated port using radio-frequency technology that is MRI conditional. Zensor™ is an RFID technology platform used to safely identify implantable devices from outside the body, and includes the company’s first biosensor Zen™, currently part of an IRB approved pivotal study to measure core breast temperature. These solutions are supported by over 200 patent applications in 20 separate patent families worldwide and over 100 scientific and clinical studies and publications in peer reviewed journals. Establishment Labs manufactures at two facilities in Costa Rica compliant with all applicable regulatory standards under ISO13485:2024 and FDA 21 CFR 820. Please visit our website for additional information at www.establishmentlabs.com. Forward-Looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"). You can find many (but not all) of these statements by looking for words such as "approximates," "believes," "expects," "anticipates," "estimates," "intends," "plans," "intends to," "would," "will," "may" or other similar expressions in this press release. Any statements that refer to projections of our future financial or operating performance, anticipated trends in our business, our goals, strategies, focus and plans, including related product development and commercialization and regulatory approvals, and other characterizations of future events or circumstances, including statements expressing general optimism about future operating results, related to the company’s performance are forward-looking statements. We claim the protection of the safe harbor contained in the Private Securities Litigation Reform Act of 1995. We caution investors that any forward-looking statements presented in this report, or that we may make orally or in writing from time to time, are expressions of our beliefs and expectations based on currently available information at the time such statements are made. Such statements are based on assumptions, and the actual outcome will be affected by known and unknown risks, trends, uncertainties, and factors that are beyond our control. Although we believe that our assumptions are reasonable, we cannot guarantee future performance, and some will inevitably prove to be incorrect. As a result, our actual future results and the timing of events may differ from our expectations, and those differences may be material. Factors, among others, that could cause actual results and events to differ materially from those described in any forward-looking statements include risks and uncertainties relating to: our ability to successfully, timely and cost-effectively develop, seek and obtain regulatory clearance for and commercialize our product offerings; the rate of adoption of our products by healthcare providers or other customers; the success of our marketing initiatives; the safe and effective use of our products; our ability to protect our intellectual property; our future expansion plans and capital allocation; our ability to expand upon and/or secure sources of credit or capital; our ability to develop and maintain relationships with qualified suppliers to avoid a significant interruption in our supply chains; our ability to attract and retain key personnel; our ability to scale our operations to meet market demands; the effect on our business of existing and new regulatory requirements; and other economic and competitive factors. These and other factors that could cause or contribute to actual results differing materially from our expectations include, among others, those risks and uncertainties discussed in the company's annual report on Form 10-K filed on February 27, 2026, which risks and uncertainties may be updated in the future in other filings made by the company with the Securities and Exchange Commission. The risks included in those documents are not exhaustive, and additional factors could adversely affect our business and financial performance. We operate in a very competitive and rapidly changing environment. New risk factors emerge from time to time, and it is not possible for us to predict all such risk factors, nor can we assess the impact of all such risk factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. We are not undertaking any obligation to update any forward-looking statements. Accordingly, investors should use caution in relying on past forward-looking statements, which are based on known results and trends at the time they are made, to anticipate future results or trends. ESTABLISHMENT LABS HOLDINGS INC.Reconciliation of EBITDA and Adjusted EBITDA(In thousands)(Unaudited) Non-GAAP Financial Measures To supplement our financial results presented in accordance with GAAP, this release includes the following measures defined by the Securities and Exchange Commission as non-GAAP financial measures: EBITDA and Adjusted EBITDA. These non-GAAP measures are not based on any comprehensive set of accounting rules or principles and should not be considered a substitute for, or superior to, financial measures calculated in accordance with GAAP and may be different from non-GAAP measures used by other companies, limiting the usefulness of the measures for comparison with other companies. EBITDA is defined as net income or loss excluding: (1) interest income and expense; (2) provision for income taxes; and (3) depreciation and amortization. We consider EBITDA useful to an investor in evaluating and facilitating comparisons of our operating performance between periods by removing the impact of our capital structure (primarily interest expense) and asset base (primarily depreciation and amortization) from our operating results. We also present Adjusted EBITDA which includes additional adjustments for items such as other non-cash charges, gains or losses on extinguishment of debt, share-based compensation, debt refinancing costs, foreign currency gains and losses and restructuring costs. We believe that Adjusted EBITDA provides useful supplemental information to investors regarding our ongoing operating performance that, when considered with net income and EBITDA, is beneficial to an investor's understanding of our performance. We believe disclosure of this information is also useful to investors as it provides insight into the earnings that management uses to make strategic decisions. These non-GAAP financial measures should be considered along with, but not as alternatives to, net income or loss as prescribed by GAAP as a measure of our operating performance. EBITDA and Adjusted EBITDA do not represent cash generated from operating activities under GAAP and should not be considered as alternatives to cash flows from operations or any other operating performance measure prescribed by GAAP. These measures are not measures of our liquidity, nor are indicative of funds available to fund our cash needs. These measurements do not reflect cash expenditures for long-term assets and other items that have been and will be incurred. EBITDA and Adjusted EBITDA may include funds that may not be available for management’s discretionary use due to functional requirements to conserve funds for capital expenditures, property acquisitions, and other commitments and uncertainties. Please see "Reconciliation of EBITDA and Adjusted EBITDA" for a reconciliation of these measures to net income (loss), the most directly comparable financial measure. This release also includes information about our expectations regarding Adjusted EBITDA on a forward-looking basis. We have not provided a reconciliation of such forward-looking Adjusted EBITDA information because a reconciliation of such measure to our expected GAAP net income (loss) on a forward-looking basis is not available without unreasonable efforts. The timing or amount of various reconciling items that would impact the forward-looking expectations for this non-GAAP financial measure are uncertain, depend on various factors and cannot be reasonably predicted. Such unavailable information could be material to our results computed in accordance with U.S. GAAP. The following is a reconciliation of net loss to EBITDA and Adjusted EBITDA: View source version on businesswire.com: https://www.businesswire.com/news/home/20260806794312/en/ Contacts Investor/Media Contact: Malavika [email protected]

Investor releaseQuarter not tagged2026-08-06

Establishment Labs Holdings Inc (ESTA) (Q2 2026) Earnings Call Highlights: U.S. Sales Surge 140. ...

GuruFocus.com
This article first appeared on GuruFocus. Revenue: $67.5 million, up 31.7% year-over-year. U.S. Revenue: $24.7 million, up 140.9% year-over-year, representing 36.6% of total revenue. OUS Revenue: $42.8 million, up 4.4% year-over-year. Minimally Invasive Platform Revenue: $12.1 million in the quarter. Gross Margin: 70.6% of revenue, up from 68.8% in the prior year period. Operating Expenses: $52 million for the quarter. Adjusted EBITDA: Income of $3.7 million, an improvement of $12.2 million from a loss of $8.5 million in the prior year period. Cash and Cash Equivalents: $71.2 million, a sequential increase of $3.1 million from Q1. Full Year Revenue Guidance: Raised to $269 million-$271 million, up from the previous range of $266.5 million-$268.5 million. Warning! GuruFocus has detected 5 Warning Sign with ESTA. Is ESTA fairly valued? Test your thesis with our free DCF calculator. Release Date: August 06, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Revenue grew 31.7% year-over-year to $67.5 million, with U.S. sales surging 140.9% to $24.7 million. Adjusted EBITDA turned positive at $3.7 million, a $12.2 million improvement from the prior year. Minimally invasive platform (Mia and Preserve) generated $12.1 million in revenue, approaching 15% of global sales and expanding the total addressable market. Surpassed 100,000 Motiva implants in the U.S. in under 21 months, with over 2,000 accounts and 75% of surgeons reporting patient brand requests. Raised full-year revenue guidance to $269-$271 million and expect to be free cash flow positive in the second half of 2026. Preserve surgeon training exceeded expectations (300+ certified, targeting 500 for the year), with procedures commanding 30-50% premium pricing. Strong OUS performance in direct markets, especially Europe (16% growth), with diversified revenue reducing exposure to volatile regions. OUS revenue growth was only 4.4%, impacted by the Middle East conflict, which has reduced orders and is expected to remain weak for the rest of the year. Third quarter is expected to be seasonally weak, with summer vacations affecting both U.S. and OUS sales. Reconstruction revenue is not expected to be material until 2027, with FDA approval timing still uncertain. Operating expenses, including one-time refinancing costs, reached $52 million, though adjusted for…Read full document

This article first appeared on GuruFocus. Revenue: $67.5 million, up 31.7% year-over-year. U.S. Revenue: $24.7 million, up 140.9% year-over-year, representing 36.6% of total revenue. OUS Revenue: $42.8 million, up 4.4% year-over-year. Minimally Invasive Platform Revenue: $12.1 million in the quarter. Gross Margin: 70.6% of revenue, up from 68.8% in the prior year period. Operating Expenses: $52 million for the quarter. Adjusted EBITDA: Income of $3.7 million, an improvement of $12.2 million from a loss of $8.5 million in the prior year period. Cash and Cash Equivalents: $71.2 million, a sequential increase of $3.1 million from Q1. Full Year Revenue Guidance: Raised to $269 million-$271 million, up from the previous range of $266.5 million-$268.5 million. Warning! GuruFocus has detected 5 Warning Sign with ESTA. Is ESTA fairly valued? Test your thesis with our free DCF calculator. Release Date: August 06, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Revenue grew 31.7% year-over-year to $67.5 million, with U.S. sales surging 140.9% to $24.7 million. Adjusted EBITDA turned positive at $3.7 million, a $12.2 million improvement from the prior year. Minimally invasive platform (Mia and Preserve) generated $12.1 million in revenue, approaching 15% of global sales and expanding the total addressable market. Surpassed 100,000 Motiva implants in the U.S. in under 21 months, with over 2,000 accounts and 75% of surgeons reporting patient brand requests. Raised full-year revenue guidance to $269-$271 million and expect to be free cash flow positive in the second half of 2026. Preserve surgeon training exceeded expectations (300+ certified, targeting 500 for the year), with procedures commanding 30-50% premium pricing. Strong OUS performance in direct markets, especially Europe (16% growth), with diversified revenue reducing exposure to volatile regions. OUS revenue growth was only 4.4%, impacted by the Middle East conflict, which has reduced orders and is expected to remain weak for the rest of the year. Third quarter is expected to be seasonally weak, with summer vacations affecting both U.S. and OUS sales. Reconstruction revenue is not expected to be material until 2027, with FDA approval timing still uncertain. Operating expenses, including one-time refinancing costs, reached $52 million, though adjusted for these, growth was modest. The company faces ongoing macroeconomic and geopolitical uncertainty across several regions, which could impact future demand. GEM, the gluteal augmentation product, is not expected to contribute to U.S. revenue until 2028, limiting near-term growth catalysts. Cash position remains relatively low at $71.2 million, though management states it is sufficient without future equity raises. Q: Can you provide more details on the development and regulatory timeline for GEM, the company's gluteal augmentation procedure?A: Peter Caldini (CEO) stated that GEM leverages the Minimally Invasive platform technology to offer a safer, more predictable alternative to the traditional Brazilian butt lift. The company is currently conducting a clinical study in Costa Rica and expects an early experience launch in Latin America in the back half of next year. They are working through the regulatory pathway for the U.S. and Europe, but do not see GEM as a contributor in the U.S. until 2028 and beyond. Q: What is the current status of the FDA submission for the breast reconstruction indication, and what is the expected timeline for approval and revenue contribution?A: Peter Caldini (CEO) confirmed they have received feedback from the FDA and are responding to routine questions. The FDA has initiated BIMO audits of clinical study sites, which is a positive sign of progress. While the approval timing is up to the FDA, the company does not expect to achieve material revenue from reconstruction until 2027. This indication doubles their total addressable market in the U.S. Q: How is the adoption and utilization of the Preserve procedure progressing in the U.S., and what are the expectations for the back half of the year?A: Peter Caldini (CEO) reported that over 300 surgeons are now trained and certified on Preserve, which is more than 50% above original expectations. The company is expanding training capacity and now targets approximately 500 trained surgeons for the full year 2026. Adoption is quick following certification, and they expect Preserve to be a key growth driver in the second half of the year. Q: What is the financial outlook for the Minimally Invasive platform, and how should we think about its contribution for the full year?A: Cassandra Harris (CFO) stated that the Minimally Invasive platform generated $12.1 million in revenue in Q2 and is performing ahead of expectations. The company previously guided to over $35 million for the year, but now expects the platform to approach approximately 15% of total company revenue for the full year, which is a higher contribution than originally anticipated. Q: Can you provide color on the company's expectations for the second half of 2026 and any preliminary thoughts on 2027?A: Peter Caldini (CEO) expects the strong momentum from the first half to continue, particularly in the U.S. and direct markets. Cassandra Harris (CFO) reminded investors of normal seasonality, with Q4 expected to be the strongest quarter. The company raised full-year revenue guidance to $269-$271 million. For 2027, the only information provided to date is an expectation for revenue growth of around 25%. Q: How is the competitive dynamic playing out for Preserve, and what is the pricing premium compared to traditional breast augmentation?A: Peter Caldini (CEO) explained that Preserve provides surgeons with a significant competitive advantage by bringing new patients into the category. Market research shows that 15% of women who had Preserve were not initially considering breast augmentation. Surgeons are charging 30%-50% more for Preserve procedures than traditional augmentations, and in the U.S., it commands a premium of more than two times that of a traditional procedure. Q: What is driving the growth outside the U.S., and how is the company managing exposure to volatile markets like the Middle East?A: Peter Caldini (CEO) highlighted that OUS growth of 4.4% was driven by strong performance in direct markets, particularly Europe, which grew 16% with strength in Italy, Germany, and the U.K. The company is de-emphasizing its dependency on distributors. While demand in most distributor markets was steady, the Middle East was an outlier due to the conflict, with orders at much lower levels. Cassandra Harris (CFO) noted that the Middle East represents less than 5% of total revenue. Q: How should investors think about the trajectory of operating expenses given the investments in the Minimally Invasive platform, reconstruction, and GEM?A: Cassandra Harris (CFO) stated that the company is leveraging its operating expenses, with single-digit growth in opex against strong double-digit revenue growth. Excluding one-time refinancing costs, operating expenses were well controlled. The company is pacing its R&D investments appropriately for the innovation pipeline and does not anticipate any major increases to previous spending levels, while continuing to look for areas of leverage. Q: If reconstruction approval were received on January 1, how quickly would it contribute to revenue, and does the 25% growth expectation for 2027 include a significant contribution from reconstruction?A: Cassandra Harris (CFO) explained that the reconstruction launch would not grow as rapidly as the Minimally Invasive platform launch, as it takes longer to work with hospitals. There is no anticipation of reconstruction revenue in 2026. The company will provide more color on the 2027 contribution once there is more clarity on FDA timing. Q: What is the impact of the Mia procedure on the market, and how is it driving the strategy for the Minimally Invasive platform?A: Peter Caldini (CEO) stated that Mia, available outside the U.S., is a key driver for the development of Preserve and the entire Minimally Invasive platform. It addresses key barriers preventing women from undergoing breast augmentation, such as minimal anesthesia, smaller scars, and quicker recovery. The platform is bringing new patients into the category and is expected to become an increasingly important growth driver in the years ahead. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

TranscriptFY2026 Q22026-08-06

FY2026 Q2 earnings call transcript

Earnings source - 70 paragraphs
Operator

Welcome to Establishment Labs's second quarter 2026 earnings call. At this time, all participants will be in a listen-only mode. At the end of this call, we'll open the line for question and answer session, and instructions will follow at that time. As a reminder, today's call is being recorded. I will now turn the call over to Malavika William, VP, Global Head of Corporate Communications and Marketing. Please go ahead.

Malavika William

Thank you, operator. Thank you, everyone, for joining us. With me today is Peter Caldini, our Chief Executive Officer, and Sandra Harris, our Chief Financial Officer. Following our prepared remarks, we'll take your questions. Before we begin, I would like to remind you that comments made by management during this call will include forward-looking statements within the meaning of federal securities laws. These include statements on Establishment Labs's financial outlook and the company's plans and timing for product development and sales. These forward-looking statements are based on management's current expectations and involve risks and uncertainties.

Malavika William

For a discussion of the principal risk factors and uncertainties that may affect our performance or cause actual results to differ materially from these statements, I encourage you to review our most recent annual and quarterly reports on Form 10-K and Form 10-Q, as well as other SEC filings, which are available on our website at establishmentlabs.com. I'd also like to remind you that our comments may include certain non-GAAP financial measures with respect to our performance, including, but not limited to, sales results, which can be stated on a constant currency basis, or EBITDA, which we disclose on an adjusted EBITDA basis. Reconciliations to comparable GAAP financial measures with non-GAAP measures, if available, may be found in today's press release, which is available on our website. The content of this conference call contains time-sensitive information accurate only as of the date of this live broadcast, August the sixth, 2026.

Malavika William

Except as required by law, Establishment Labs undertakes no obligation to revise or otherwise update any statement to reflect events or circumstances after the date of this call. With that, it is my pleasure to turn the call over to Peter.

Peter Caldini

Good morning and thank you for joining us. Q2 was another strong quarter for Establishment Labs. We delivered revenue of $67.5 million and adjusted EBITDA of $3.7 million, representing revenue growth of 31.7% over the same period last year. The U.S. business once again outperformed, generating revenue of $24.7 million, an increase of over 140% compared to the same quarter last year, an increase of 26% from Q1. Outside the United States, our business grew steadily at 4.4%, supported by strong execution in our direct markets and steady demand with our distributors. Our minimally invasive platform continued to emerge as an important growth driver globally, generating $12.1 million in revenue during the quarter. We're off to a good start in Q3, which is traditionally the seasonal low point of our industry.

Peter Caldini

A result of our first half performance, we are raising our full year revenue guidance to $269 million-$271 million, up from our previous range of $266.5 million-$268.5 million. Minimally invasive is approaching 15% of our global business for the year and is expanding our total addressable market. We should transition to free cash flow positive during the second half of 2026 and be free cash flow positive for fiscal 2027. Our recent inclusion in the Russell 2000 Index, we have quite a bit of new interest in our story, and this was a focus of our Q1 call, where we walked through the technological foundation of our business and what makes Establishment Labs different. If you're joining us for the first time, I'd encourage you to read the transcript from that call.

Peter Caldini

It provides a good overview of our product differentiation, strategy, and the long-term opportunity we see ahead. We aren't just looking to take share from others in breast aesthetics and reconstruction. We're looking to meaningfully expand the market. Breast aesthetics has been heavily underinvested for years and we remain the only company bringing meaningful improvements and differentiated technologies to the market. Our goal has never been to be another implant company. Our goal is to be a major contributor to women's health. We started with Motiva Implant, a product developed through years of investment in science, engineering, and clinical research. It has shown the strongest safety data in the industry, and this has been the foundation for one of the fastest launches in the U.S. breast aesthetics.

Peter Caldini

Our technology platform allows us to do so much more, we are already seeing how it enables an entirely new category of procedures through the introduction of minimally invasive. Today, that platform consists of two procedures, Mia and Preservé. A third procedure called GEM is currently in development and represents a potential breakthrough in gluteal augmentation, offering what could be a safer and more predictable alternative to the Brazilian butt lift. Mia and Preservé are built on the tissue-preserving principles that Establishment Labs has pioneered and patented. The surgeries are designed to preserve native breast tissue, sensation, and chest muscles. The focus on preservation delivers clear benefits to the patient. Minimal anesthesia with barely noticeable scars and a significantly reduced recovery time compared to traditional breast augmentation.

Peter Caldini

Preservé accommodates a broader range of patient needs, including larger augmentations and augmentation mastopexy procedures while maintaining the same principles of tissue preservation and faster recovery. Mia, which is currently available outside the U.S., is designed for women seeking a more subtle enhancement, typically one to two cup size increase. The procedure uses our Ergonomix2 diamond implant, offering a scarless breast with a small incision made in the underarm. The implant is one of the major differences between Mia and Preservé. It is a patented new shape, breaking a decades-old dichotomy of round and teardrop implants. This shape, which is symmetrical, has more volume in the middle, creating more projection with a smaller volume implant. This shape is the first of its kind, truly innovative, and has many usage opportunities as we expand our efforts in minimally invasive.

Peter Caldini

The softness and lightweight design allow for an augmentation that aims to integrate so well with the body that women forget they have implants. Also of note, we developed a patented automated injector for Mia, replacing the current manual insertion process used in traditional breast augmentations. Today, implants are generally placed either by hand or through a device known as a funnel. The injector offers a far more seamless process and simplifies what can be one of the more challenging parts of the surgery, and over time could become a new standard in the industry. As you learn about our technology, it's worth reading the supplement on Preservé that has been accepted and should be published later this year in the "Aesthetic Surgery Journal." This is a compendium of peer-reviewed clinical data specifically on breast tissue preservation and the techniques.

Peter Caldini

It focuses on the science, anatomy, and clinical outcomes of breast tissue preservation, and our hope is that it will become foundational learning for plastic surgeons as they adopt Preservé. Minimally invasive is being very well received by the market, with adoption even at higher price points. Two things are happening here. First, minimally invasive options are bringing new patients into the category that have never previously considered a breast augmentation. Second, patients already considering breast augmentation are opting for this procedure even though it's more expensive. For Establishment Labs in the U.S., Preservé commands a premium of more than two times that a traditional breast augmentation procedure. Not only are we expanding the market, but it appears that women are deciding to get the procedure much faster than they traditionally have.

Peter Caldini

Historically, women could take years between their first thoughts of having breast augmentation and actually getting a surgery. The appeal of minimally invasive is shortening that consideration time. Since launch, we have seen any number of cases where women take months, and in some cases days, from consideration to surgery. We believe we're still in the very early stages of this opportunity. There is significant potential for market expansion, and we expect it to become an increasingly important driver for our growth in the years ahead. Turning to the quarter, the U.S. continues to be the primary growth engine for our business, now representing 36.6% of total company revenue, up from 20% a year ago. Another milestone, in Q2, we surpassed 100,000 Motiva implants in the U.S. market in under 21 months since launch.

Peter Caldini

We are still early in our U.S. journey, but crossing 100,000 implants is an important reminder of how quickly the market has embraced our technology and how much opportunity remains ahead of us. What continues to stand out is the depth of adoption we're seeing. At the end of the quarter, we had surpassed 2,000 accounts in the United States. Many accounts have multiple surgeons using our implants. While we continue to open new accounts, an increasing percentage of our growth is now being driven by utilization within existing accounts. As surgeons become more familiar with the clinical data, products, differentiators, and patient outcomes, we are seeing adoption strengthen, particularly among early adopters and high volume accounts, where Motiva now represents a significant percentage of their practice.

Peter Caldini

One surgeon who adopted Motiva immediately following FDA approval shared that he has completed approximately 300 Motiva cases in his first year and has now converted nearly his entire augmentation practice. Another surgeon shared that for the first time in his more than 25-year career, patients are actively requesting Motiva by name, and that increased demand is translating directly into higher surgery volumes. We're also seeing that even when women have a warranty from another company that offers a free replacement, they are paying for Motiva implants themselves. These experience seem to be representative of what we're increasingly hearing across our customer base. Late adopters are also beginning to show interest, particularly as patients' demand for Motiva continues to build.

Peter Caldini

In a category where patients historically have rarely asked for a specific implant brand, 75% of surgeons now report that patients are asking, and 93% of the time, that brand is Motiva. That level of consumer awareness remains highly unusual in breast aesthetics and continues to be a powerful driver of adoption, making Motiva increasingly difficult for practices to ignore. Preservé is also emerging as an important growth driver in our U.S. business. We ended the quarter with over 300 surgeons trained and certified on their procedure, which is more than 50% above our original expectations for the year. There is no shortage of surgeon interest, and they now have multiple training pathways available both in the United States and our global innovation hub in Costa Rica. We continue to see relatively quick adoption following certification.

Peter Caldini

The benefits of Preservé are showing up across both traditional and digital media outlets. In the limited time that Preservé has been on the market, it has been mentioned as the new breast augmentation option, commonly discussed on social media platforms and in the media, including in feature articles from People and Allure, as well as The Zoe Report and The Washington Post, to name a few. Surgeons report they are charging between 30%-50% more for Preservé procedure than for their traditional breast augmentations, confirming that patients value these benefits and are willing to pay for them. Our success is suggestive that we are only in the early innings of something that could fundamentally change the category.

Peter Caldini

Also interesting, we are hearing from some surgeons that because of the very limited downtime with Preservé, they have booked surgeries throughout the summer, which is unusual because the summer months are traditionally slower for breast augmentations. One of our earliest adopters performed five breast augmentations in July and August last year. This year, he's already scheduled for 50 in the same time period. As we have discussed previously, a major focus of our strategy is expanding and strengthening our direct markets outside the U.S., and we are pleased with the progress we continue to make. Over the past year, we have not only strengthened leadership across several of our key markets, but also prioritized resources in those markets, and those investments are translating into stronger growth. Growth was broad-based across many of our regions, driven by strong execution and an increase in the number of accounts.

Peter Caldini

Europe, where we have the most direct markets, delivered 16% growth and was especially strong in Italy, Germany, and the U.K. In Latin America, Argentina continued its positive trajectory from Q1, while Brazil maintained its path of stability, driven predominantly by our minimally invasive platform. Our minimally invasive platform remains an important contributor to growth outside the United States and continues to support adoption across the more than 40 markets worldwide. In general, demand trends remained stable throughout the quarter, despite continued macroeconomic and geopolitical uncertainty across several regions. Our exposure to the most volatile markets remains limited, and we continue to benefit from a highly diversified global business. As we look ahead, we continue to advance our innovation pipeline. This includes our reconstruction submission with the FDA, the expansion of our U.S. product matrix through smaller implant sizes, and the continued development of GEM.

Peter Caldini

All of these will help us take market share and expand the market. With that, I'll turn the call over to Sandra to discuss our financial results in more detail.

Sandra Harris

Thank you, Peter. The second quarter was another important step forward financially. We continued to deliver strong top-line growth while expanding margins and generating positive adjusted EBITDA with improving cash flow. As our U.S. business and minimally invasive platform continue to scale, we're seeing increasing operating leverage across the organization. Total revenue for the second quarter was $67.5 million, an increase of 31.7% compared to the second quarter of 2025. In the United States, revenue was $24.7 million, representing growth of 140.9% compared to the prior year. The U.S. now represents 36.6% of total company revenue and continues to be our fastest-growing region. Growth was driven by continued adoption of Motiva and increasing contribution from our minimally invasive platform. Geographically, our business outside the United States continues to perform well. OUS revenue was $42.8 million during the quarter, representing growth of 4.4% over the second quarter of 2025.

Sandra Harris

Our minimally invasive platform generated $12.1 million in revenue during the quarter and continues to perform ahead of our original expectations. Gross profit for the second quarter was $47.7 million, or 70.6% of revenue, compared to 68.8% in the prior year period. Gross margin expansion was primarily driven by the increasing contribution of our higher-margin U.S. and OUS direct markets, favorable product mix, and the continued growth of our minimally invasive platform. Operating expenses remained well controlled, increasing modestly despite revenue growth of nearly 32%, reflecting continued operating leverage across the business. Adjusted EBITDA improved by $12.2 million to income of $3.7 million, compared to a loss of $8.5 million in the prior year period.

Sandra Harris

We ended the quarter with cash and cash equivalents of $71.2 million, a sequential increase of $3.1 million from Q1 and $16.5 million higher than the same quarter last year, and generated positive overall cash flow. This milestone reflects the strong progress we have made improving profitability, expanding margins, and driving greater operating efficiency throughout the organization. Importantly, we have sufficient liquidity to execute our strategy and continue investing in future growth opportunities without the need for future equity raises. Given our strong first half performance and continued momentum across the business, we are increasing our full year revenue guidance to between $269 million and $271 million. We expect the U.S. business to be the primary driver of growth, while our OUS business remains healthy and diversified. As we look to the third quarter, I'd like to remind investors it is historically this business should reflect the normal seasonal pattern.

Sandra Harris

As always, we expect our strongest quarter to be the fourth. We remain very encouraged by the performance of the business, the continued momentum in the United States, the growing contribution of our minimally invasive platform, and the increasing profitability profile of Establishment Labs. Now, I'll turn the call back over to Peter.

Peter Caldini

Thank you, Sandra. As you've heard today, we continue to execute well across the business. The U.S. remains a significant growth driver. Our OUS markets continue to perform well. Our minimally invasive platform is gaining momentum globally, and we have a clear path to being free cash flow positive. At the same time, we continue to advance a pipeline that should support growth for many years to come. While we are proud of what we've accomplished so far, we believe the opportunity ahead remains substantially larger than what we've achieved to date. Operator, we're now ready to take questions.

Operator

Thank you. Ladies and gentlemen, we will now begin the question and answer session. If you have a question, please press star followed by the number one on your touchtone phone. You will hear a three-tone prompt acknowledging your request. Please limit yourself to one question. If you wish to do a follow-up, please hit queue. If you would like to cancel your request, please press star two. One moment please for your first question. Your first question comes from the line of Josh Jennings from TD Cowen. Please go ahead.

Josh Jennings

Hi, good morning, Peter and Sandra. Thanks for taking the questions. Great to see another strong quarter, especially the U.S. momentum. Appreciate your comments on Mia during the call so far. Our checks have suggested that there's some optimism in U.S. plastic surgeons that Mia ultimately could produce an entire new category in the aesthetic space where you could transition breast augmentation from a surgery to an injectable procedure. Is there any plans to kind of drive that notion and just that segmentation here in the international markets where you've launched and then ultimately in the U.S.? How does that all play out?

Peter Caldini

Yeah. Thank you, Josh. Listen, I think that what we've always highlighted around the minimally invasive platform, this is truly an innovation in a category that hasn't seen innovation. Mia, as you highlighted, is just outside the U.S. We've had good traction. It's also a key driver for the development of Preservé. Part of this entire minimally invasive platform, I think is a significant growth driver for us. It brings in a number of new patients to the category. We've seen that through market research in the U.S., it's about 15% with Preservé. Outside the U.S., similar type of numbers. It does address a number of the barriers that are preventing women from doing a breast augmentation. When you talk about minimal anesthesia, you talk about also those smaller scars and quicker recovery.

Peter Caldini

It'll continue to be a key driver for us. We're just in really the early stages of that development. We're seeing that impact in the U.S. and also outside the U.S.

Josh Jennings

Thanks for that. I know I'm focused on the pipeline here with my questions, but you referenced GEM on the call so far. It seems like there's a potential for, we may be getting too aggressive with our assumptions, but a potential for initial OUS commercial launch maybe next year. Any more details you can provide on where that development program stands and any kind of regulatory or commercial milestones we should have on our catalyst calendar? Thanks for taking the questions.

Peter Caldini

Josh, regarding GEM, we see this as a tremendous opportunity, really leveraging a lot of the technology from the minimally invasive platform in really providing a safer alternative, also with more predictable results to the traditional Brazilian butt lift. Where we are in that process is, we're doing a clinical study in Costa Rica. We expect next year in the back half to do an early experience in Latin America. Right now we're really working through what that regulatory pathway is going to be for the U.S. as well as OUS, primarily in Europe. We're very pleased with the progress we've made so far. It's a very differentiated technology, and we see this as very much an on-tap market.

Peter Caldini

In terms of timing for, let's say, the U.S., we have so many things that we're going to be driving growth over the next couple of years. We don't see that really as a contributor in the U.S. until 2028 and beyond. We're still working through what that regulatory pathway is going to be.

Operator

Your next question comes from the line of Sam Eiber from U.S. Bancorp. Please go ahead.

Sam Eiber

Hi. Good morning. Thanks for taking the questions here, and congrats on the nice quarter. I want to come back to Preservé in the U.S., 300 surgeons now certified. Curious what you're hearing from the field in terms of utilization and adoption, their own plans to expand Preservé within their practice, generally thoughts around the procedure and what it can mean for the U.S. business over the back half of the year.

Peter Caldini

Yeah. Thanks, Sam. It's pretty clear we're off to a great start with Preservé. There's significant demand. I think our original target was around 200 surgeons. We quickly surpassed that. We're really expanding our capacity in terms of training. There's no shortage of surgeons that are interested. What we're finding is that, as soon as they're certified, it's very quick adoption in terms of the initial ordering, and then it's a process of working through their schedules and getting the right patients. We fully expect that this is going to be continually a key driver for our growth in the back half of this year. We're targeting to train approximately 500 surgeons for the full year 2026.

Peter Caldini

This is really driven by tremendous demand in the marketplace, and it is addressing a significant barrier that patients have with doing a breast augmentation, and that's really been playing out in what we're seeing in the marketplace.

Sam Eiber

Okay. Really helpful. Maybe if I could just squeeze in a quick follow-up. The global minimally invasive revenue for the quarter, $12 million, certainly passed our expectations. As I think about the prior $35 million guidance, it seems like you're on pace to achieve well beyond that. I guess, any updated thoughts on how we should be thinking about that number?

Sandra Harris

Yeah, Sam, I think we said over $35 million, and what we've said recently is that we're going to be approaching, for the full year, about 15% of our revenue. I think that depending upon how you look at our guidance, that gives you the guide for minimally invasive going forward.

Sam Eiber

Okay, great. Thanks for taking the questions.

Operator

Your next question comes from the line of Mason Carrico from Stephens. Your line is now open.

Mason Carrico

Hey, guys. Thanks for-

Peter Caldini

Sure

Mason Carrico

taking the questions here. Could you give a sense of Motiva mix among Preservé-trained surgeons compared to that of an untrained one? Have you seen Preservé certification lift overall Motiva mix or share at that account? I guess, longer term, what percentage of your U.S. volumes do you think could ultimately be Preservé?

Peter Caldini

Yeah. Thanks. We are seeing in the accounts, there's such strong interest in Preservé. It's truly a unique innovation in the marketplace that's really been starving for innovation. We're seeing strong interest and a number of surgeons are really, once they get trained and accustomed to using Preservé, a lot of them see this as really the future of the industry, it will continue to be a bigger part of the practice. It generates a significant revenue opportunity for them. We see that over time, that will continue to be a bigger part of that market. In terms of the split, I don't Sandra?

Sandra Harris

Yeah. In terms of the split, I don't know that we've really talked about the split between the U.S. and the OUS, it's going to be a very important part of our ability to expand the market and to continue to take market share in the U.S.

Operator

Your next question comes from the line of Caitlin Cronin from Canaccord Genuity. Please go ahead.

Caitlin Roberts

Great. Thanks so much for taking the question and congrats on a great quarter. Would love to touch on recon. Have you had any convos with the FDA on the recon indication and updated expectations for this approval timeline? How many hospitals are you now in the Flora? Thank you.

Peter Caldini

Yeah. Thanks, Caitlin. Obviously, recon is a tremendous opportunity for us. It doubles the TAM for us in the U.S., and we fully expect to have the same level of success in recon in the U.S. that we've experienced in augmentation. In terms of the feedback, we have heard back from the FDA. We're in the process of responding to what we consider some routine questions. What I think is very positive, they now started the BIMO audits of our clinical study sites, which I think is a normal part of the process, and I think it's a good indication that things are progressing well. In terms of the actual approval timing, it's really up to the FDA. What we're seeing, everything is positive, moving in the right direction.

Peter Caldini

Just to remind everybody, we don't really expect from a planning standpoint to achieve material revenue in recon until 2027.

Operator

Your next question comes from the line of Joanne Wuensch from Citi. Your line is now open.

Jane-Marie Lai

Hello, this is Jane Marie Lai on for Joanne from Citi. Thanks for the question. At this half-year mark, could you provide more color on your expectations for the second half of the year? I know it's a bit early, but for 2027, how should we think about that? Do you have any kind of color on that as well?

Peter Caldini

I'm not sure I've fully heard the question. My understanding is what's our expectation in terms of the back half of the year. Listen, I think we're going to continue to see the strong momentum that we've experienced in the first half, especially with the U.S., but also in terms of how we're driving growth in our direct markets. We expect that momentum to continue in the back half of the year. I think there's significant continued growth opportunities with our platforms and the different initiatives that we're driving. We haven't really set any guidance as it relates to 2027, but I'll pass that over to Sandra.

Sandra Harris

Just as it relates to this year, I'll just remind you of our seasonality, and we do anticipate that our fourth quarter is always the strongest quarter of the year, with the third quarter being impacted by some seasonal impact around the summer and vacation periods in both our OUS business and our U.S. business. What we did is we have raised our guidance to $269-$271. In regards to 2027, the only information we've provided to date is that, we do expect that revenue next year would be around the 25% growth mark.

Operator

Your next question comes from the line of Anthony Petrone from Mizuho Financial Group. Please go ahead.

Anthony Petrone

Thanks. Congrats on the strong print here. Maybe one on Preservé competitive dynamics and then pricing. Just on Preservé, when you think about site adoption in the U.S. specifically, one of the med tech phenomenons, for instance, with da Vinci Surgical, you sort of have da Vinci in your practice in the early days, and it represents a competitive advantage for that site. That site then gains share from its competitors. To what extent do you think Preservé is going to allow surgeon sites to have competitive advantages versus its competitors? When do you think that tipping point actually happens? Just on unit economics, can you remind us where Preservé sits per case versus Motiva? When you think about Recon, how pricing will settle out there? Thanks.

Peter Caldini

All right. Thanks, Anthony. In terms of Preservé, as we highlighted, we're really in the early innings in the U.S., but the feedback has been incredibly positive from the surgeons. We continually get approached by surgeons, and we expect that to continue to grow. As I mentioned previously, we're building out or expanding our capacity to do the training. For us, I think that's going to be the surgeons that are using Preservé, it provides them a significant competitive advantage in the market, and I think that's where such a strong interest is. We've seen from market research that 15% of women who have done Preservé were not initially considering doing a breast augmentation until they heard about Preservé. It really has the potential to be a category driver and bring additional patients to the surgeon.

Peter Caldini

We see that as a competitive advantage, and that's probably why we have such significant demand from different surgeons. In terms of the Recon, we highlighted we're making good progress from a regulatory standpoint. This clearly is a significant increase in terms of the ASP in the Recon segment. It also really doubles our total addressable market in the U.S. We're very pleased with the progress we're making there. I think we've already laid a decent foundation with the Flora, just getting our foot in the door in a number of facilities, but we still have to go through that process.

Operator

Your next question comes from the line of Mike Matson from Needham & Company. Please go ahead.

Mike Matson

Thanks. I heard the growth is kind of 4% outside the U.S., but just curious if you're seeing or saw any sort of impact from the Iran war in either the Middle East or the broader international business in the quarter.

Peter Caldini

Thanks, Mike. We've had, I think, very solid growth outside the U.S., a lot of that's been driven by our direct markets, in particular in Europe. We've achieved 16% growth this quarter versus the same quarter last year, very pleased with that. That's very important for us because we prioritize those markets. These are our markets where we have better economics. We've made a number of leadership changes. We're also increasing the resources, it's really reflected in terms of our performance. What we're trying to do is de-emphasize our dependency on the distributors, I think we're really establishing that, I think we've been very effective in doing it. Specifically, I would say across most of our distributor markets, I think demand has been steady. The one outlier is what you highlighted is the Middle East, obviously with the conflict there.

Peter Caldini

We have had orders, it's at a much lower level than what we've experienced in the past. We don't expect that to change for the remainder of the year. This is in terms of the spillover in other markets, we haven't really seen that, we're going to continue to monitor that very closely and course correct where necessary.

Sandra Harris

Mike, just as a reminder, Middle East is less than 5% of our revenue.

Operator

Your next question comes from the line of Allen Gong from J.P. Morgan. Please go ahead.

Allen Gong

Thanks for the question. I guess just on the cost front, when we look at your operating spend for the quarter, excluding the refinancing costs, came in better than expected. When we look forward, there's clearly a lot to invest into between continued launch of the minimally invasive platform and upcoming reconstruction, not to mention GEM. How should we think about the trajectory of SG&A and R&D spend in the balance of the year?

Sandra Harris

Yeah. Thanks, Allen, for the question. As you noted, we are making progress leveraging our operating expenses. As you noted, we had some one-time costs in the quarter that made our overall operating expenses around $52 million, but when you adjust for that, we're seeing that basically we have leveraged our operating expense in relation to our sales growth. Single-digit growth in operating expenses with strong double-digit growth in revenue. As we look out, we have had a very healthy investment in our R&D efforts around our innovation pipeline, and I think we've been investing at the right rate to bring that innovation. To date, we're not anticipating any major increases to what we've previously seen. We think we're pacing our innovation pipeline appropriately, and we continue to look for areas of opportunity to leverage our expenses as we grow the business across the organization.

Operator

Your next question comes from the line of Matthew Taylor from Jefferies. Please go ahead.

Matthew Taylor

Hi. Good morning. Thanks for taking the question. I wanted to ask a follow-up on Recon, maybe I'll weave that into a 2027 question. I guess my question is, hypothetically, if you got Recon approval on January 1st, I'm just interested in how quickly that would start to contribute and how quickly you can launch it. When you talked about 25% growth-ish next year, does that include a lot of Recon contribution, or would you grow 25% without it? Thanks.

Sandra Harris

Yeah. In regard to Recon, I think what we've said in the past is that we don't anticipate we would grow as rapidly as we have with our launch of our minimally invasive platform. It does take a longer period of time as we work with the hospitals. As far as what's in our guidance for this year, I think we've said that we don't have any anticipation for Recon this year. As we work toward 2027, we'll provide more color on that based upon what we know from the FDA timing.

Operator

There are no further questions at this time. I will now turn the call over to Mr. Peter Caldini for closing comments.

Peter Caldini

Thank you, operator, and thank you everybody for joining the call today. Really appreciate the time. As you can see, we're making great progress in terms of the growth with Establishment Labs. Really applying a lot of financial discipline, but at the same time making sure we deliver in terms of the revenue expectations. We have a tremendous portfolio, tremendous opportunity of innovation, and we continue to capitalize on that in terms of great execution. Once again, thanks everybody for joining the call today. Look forward to catching up in the follow-up calls as well as upcoming conferences. Thank you.

Operator

Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect.

Investor releaseQuarter not tagged2026-07-23

Establishment Labs® to Announce Second Quarter 2026 Financial Results on August 6

Business Wire
NEW YORK, July 23, 2026--(BUSINESS WIRE)--Establishment Labs Holdings Inc. (NASDAQ: ESTA), a global medical technology company dedicated to improving women’s health and wellness, principally in breast aesthetics and reconstruction, plans to announce its financial results for the quarter ended June 30, 2026, before the market opens on Thursday, August 6, 2026, and will host a conference call at 8:30 AM ET that day to discuss those results. To participate in the conference call, Dial: (+1) 888-396-8049 (US & Canada) / (+1) 416-764-8646 (international). The call will also be available via live or archived webcast on the "Investor Relations" section of the Establishment Labs website at www.establishmentlabs.com About Establishment Labs Establishment Labs Holdings Inc. is a global medical device company dedicated to improving women’s health and wellness in breast aesthetics and reconstruction through the power of science, engineering, and technology. The company offers a portfolio of solutions for breast health, breast aesthetics, and breast reconstruction in over 100 countries. With five million Motiva® devices delivered to plastic and reconstructive surgeons since 2010, the company’s products have created a new standard for safety and patient satisfaction. The company’s minimally invasive platform consists of Mia Femtech®, a unique minimally invasive experience for breast harmonization, and Preservé™, a breast tissue preserving and minimally invasive technology for primary breast augmentation and primary mastopexy augmentation. GEM® is a next generation minimally invasive system for gluteal ergonomic modeling currently undergoing an IRB approved pivotal study. The Motiva Flora® tissue expander is used to improve outcomes in breast reconstruction following breast cancer and is the only regulatory-approved expander in the world with an integrated port using radio-frequency technology that is MRI conditional. Zensor™ is an RFID technology platform used to safely identify implantable devices from outside the body, and includes the company’s first biosensor Zenº™, currently part of an IRB approved pivotal study to measure core breast temperature. These solutions are supported by over 200 patent applications in 20 separate patent families worldwide and over 100 scientific and clinical studies and publications in peer reviewed journals. Establishment Labs manufactures…Read full document

NEW YORK, July 23, 2026--(BUSINESS WIRE)--Establishment Labs Holdings Inc. (NASDAQ: ESTA), a global medical technology company dedicated to improving women’s health and wellness, principally in breast aesthetics and reconstruction, plans to announce its financial results for the quarter ended June 30, 2026, before the market opens on Thursday, August 6, 2026, and will host a conference call at 8:30 AM ET that day to discuss those results. To participate in the conference call, Dial: (+1) 888-396-8049 (US & Canada) / (+1) 416-764-8646 (international). The call will also be available via live or archived webcast on the "Investor Relations" section of the Establishment Labs website at www.establishmentlabs.com About Establishment Labs Establishment Labs Holdings Inc. is a global medical device company dedicated to improving women’s health and wellness in breast aesthetics and reconstruction through the power of science, engineering, and technology. The company offers a portfolio of solutions for breast health, breast aesthetics, and breast reconstruction in over 100 countries. With five million Motiva® devices delivered to plastic and reconstructive surgeons since 2010, the company’s products have created a new standard for safety and patient satisfaction. The company’s minimally invasive platform consists of Mia Femtech®, a unique minimally invasive experience for breast harmonization, and Preservé™, a breast tissue preserving and minimally invasive technology for primary breast augmentation and primary mastopexy augmentation. GEM® is a next generation minimally invasive system for gluteal ergonomic modeling currently undergoing an IRB approved pivotal study. The Motiva Flora® tissue expander is used to improve outcomes in breast reconstruction following breast cancer and is the only regulatory-approved expander in the world with an integrated port using radio-frequency technology that is MRI conditional. Zensor™ is an RFID technology platform used to safely identify implantable devices from outside the body, and includes the company’s first biosensor Zenº™, currently part of an IRB approved pivotal study to measure core breast temperature. These solutions are supported by over 200 patent applications in 20 separate patent families worldwide and over 100 scientific and clinical studies and publications in peer reviewed journals. Establishment Labs manufactures at two facilities in Costa Rica compliant with all applicable regulatory standards under ISO13485:2024 and FDA 21 CFR 820. Please visit our website for additional information at www.establishmentlabs.com. Forward-Looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"). You can find many (but not all) of these statements by looking for words such as "approximates," "believes," "expects," "anticipates," "estimates," "intends," "plans," "intends to," "would," "will," "may" or other similar expressions in this press release. Any statements that refer to projections of our future financial or operating performance, anticipated trends in our business, our goals, strategies, focus and plans, including related product development and commercialization and regulatory approvals, and other characterizations of future events or circumstances, including statements expressing general optimism about future operating results, related to the company’s performance are forward-looking statements. We claim the protection of the safe harbor contained in the Private Securities Litigation Reform Act of 1995. We caution investors that any forward-looking statements presented in this report, or that we may make orally or in writing from time to time, are expressions of our beliefs and expectations based on currently available information at the time such statements are made. Such statements are based on assumptions, and the actual outcome will be affected by known and unknown risks, trends, uncertainties, and factors that are beyond our control. Although we believe that our assumptions are reasonable, we cannot guarantee future performance, and some will inevitably prove to be incorrect. As a result, our actual future results and the timing of events may differ from our expectations, and those differences may be material. Factors, among others, that could cause actual results and events to differ materially from those described in any forward-looking statements include risks and uncertainties relating to: our ability to successfully, timely and cost-effectively develop, seek and obtain regulatory clearance for and commercialize our product offerings; the rate of adoption of our products by healthcare providers or other customers; the success of our marketing initiatives; the safe and effective use of our products; our ability to protect our intellectual property; our future expansion plans and capital allocation; our ability to expand upon and/or secure sources of credit or capital; our ability to develop and maintain relationships with qualified suppliers to avoid a significant interruption in our supply chains; our ability to attract and retain key personnel; our ability to scale our operations to meet market demands; the effect on our business of existing and new regulatory requirements; and other economic and competitive factors. These and other factors that could cause or contribute to actual results differing materially from our expectations include, among others, those risks and uncertainties discussed in the company's annual report on Form 10-K filed on February 27, 2026, which risks and uncertainties may be updated in the future in other filings made by the company with the Securities and Exchange Commission. The risks included in those documents are not exhaustive, and additional factors could adversely affect our business and financial performance. We operate in a very competitive and rapidly changing environment. New risk factors emerge from time to time, and it is not possible for us to predict all such risk factors, nor can we assess the impact of all such risk factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. We are not undertaking any obligation to update any forward-looking statements. Accordingly, investors should use caution in relying on past forward-looking statements, which are based on known results and trends at the time they are made, to anticipate future results or trends. View source version on businesswire.com: https://www.businesswire.com/news/home/20260723502579/en/ Contacts Investor/Media Contact:Malavika [email protected]

Investor releaseQuarter not tagged2026-05-12

ESTA Founder Sells $7.9M on Earnings Day — Here's Why that's Not the Story

Motley Fool
On May 6, 2026, Founder and former CEO Juan José Chacón Quirós, now serving as a director and paid consultant, reported the indirect sale of 105,000 shares of Establishment Labs Holdings Inc. (NASDAQ:ESTA) for a total of approximately $7.92 million, according to a SEC Form 4 filing. Transaction value based on SEC Form 4 weighted average purchase price ($75.42); post-transaction value based on May 6, 2026 market close price ($74.54). What portion of the insider’s total position was impacted by this sale? This sale represented 9.74% of Chacon Quiros’s combined direct and indirect holdings, or 10.17% of the indirect position managed through Sariel Group Ltd, with no direct shares traded in this event. What is the ownership structure and how does the indirect nature of this sale affect control? The 105,000 shares were held indirectly through Sariel Group Ltd; although Chacon Quiros has voting and dispositive power, he disclaims beneficial ownership except for his pecuniary interest, which is typical for entity-structured insider holdings. How does this transaction compare to the insider’s historical trading cadence and capacity? The 105,000-share sale is the largest single sale by Chacon Quiros to date. With a large block of direct shares transferred into Sariel Group in March 2026, the pool available for future direct-share transactions is considerably smaller than it was a year ago, meaning future sale sizes are increasingly constrained by available capacity rather than discretionary moderation. What does the conclusion of the 10b5-1 plan mean for future trading activity? With all shares subject to the December 2025 10b5-1 plan now sold, any future activity would require adoption of a new plan or be subject to open-market trading windows, potentially reducing the predictability of sale cadence going forward. * 1-year performance calculated using May 9th, 2026 as the reference date. Offers silicone gel-filled breast implants (Motiva Implants, Motiva Ergonomix, Motiva Ergonomix2), Motiva Flora Tissue Expander, and distributes Puregraft products for autologous adipose tissue harvesting. Generates revenue primarily through the manufacturing and direct or distributor-based sales of medical devices for aesthetic and reconstructive plastic surgery. Serves plastic surgeons and healthcare providers in Europe, Latin America, the Asia-Pacific, and other international mar…Read full document

On May 6, 2026, Founder and former CEO Juan José Chacón Quirós, now serving as a director and paid consultant, reported the indirect sale of 105,000 shares of Establishment Labs Holdings Inc. (NASDAQ:ESTA) for a total of approximately $7.92 million, according to a SEC Form 4 filing. Transaction value based on SEC Form 4 weighted average purchase price ($75.42); post-transaction value based on May 6, 2026 market close price ($74.54). What portion of the insider’s total position was impacted by this sale? This sale represented 9.74% of Chacon Quiros’s combined direct and indirect holdings, or 10.17% of the indirect position managed through Sariel Group Ltd, with no direct shares traded in this event. What is the ownership structure and how does the indirect nature of this sale affect control? The 105,000 shares were held indirectly through Sariel Group Ltd; although Chacon Quiros has voting and dispositive power, he disclaims beneficial ownership except for his pecuniary interest, which is typical for entity-structured insider holdings. How does this transaction compare to the insider’s historical trading cadence and capacity? The 105,000-share sale is the largest single sale by Chacon Quiros to date. With a large block of direct shares transferred into Sariel Group in March 2026, the pool available for future direct-share transactions is considerably smaller than it was a year ago, meaning future sale sizes are increasingly constrained by available capacity rather than discretionary moderation. What does the conclusion of the 10b5-1 plan mean for future trading activity? With all shares subject to the December 2025 10b5-1 plan now sold, any future activity would require adoption of a new plan or be subject to open-market trading windows, potentially reducing the predictability of sale cadence going forward. * 1-year performance calculated using May 9th, 2026 as the reference date. Offers silicone gel-filled breast implants (Motiva Implants, Motiva Ergonomix, Motiva Ergonomix2), Motiva Flora Tissue Expander, and distributes Puregraft products for autologous adipose tissue harvesting. Generates revenue primarily through the manufacturing and direct or distributor-based sales of medical devices for aesthetic and reconstructive plastic surgery. Serves plastic surgeons and healthcare providers in Europe, Latin America, the Asia-Pacific, and other international markets. Establishment Labs Holdings Inc. is a global medical technology company specializing in advanced breast implant solutions and related surgical devices. The company leverages proprietary product designs and a diversified international distribution network to address the needs of plastic and reconstructive surgeons. Its focus on innovation and international market access underpins its competitive position in the medical devices sector. This sale was pre-scheduled under a 10b5-1 plan adopted in December 2025, so the timing — which landed on the same day as Q1 earnings — is coincidental, not a read on results. Chacon Quiros is the founder and former CEO who stepped down in early 2025 and now serves as a paid consultant and board director, with nearly 973,000 shares still held between his entity and direct stake. The more relevant numbers are in the Q1 release: US revenue hit $19.6 million, up 13.3% from Q4 2025, and the company posted its third consecutive quarter of positive adjusted EBITDA. Full-year guidance was raised and management is targeting free cash flow positive in the second half of 2026. A reconstruction approval application is pending on top of the existing augmentation clearance. If you're evaluating ESTA, the question isn't what the founder did with a pre-scheduled slice of his position — it's whether the US ramp sustains and whether the reconstruction approval adds a second growth leg. Those are the variables worth tracking before making a position decision. Before you buy stock in Establishment Labs, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Establishment Labs wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you’d have $471,827!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you’d have $1,319,291!* Now, it’s worth noting Stock Advisor’s total average return is 986% — a market-crushing outperformance compared to 207% for the S&P 500. Don't miss the latest top 10 list, available with Stock Advisor, and join an investing community built by individual investors for individual investors. See the 10 stocks » *Stock Advisor returns as of May 11, 2026. Seena Hassouna has no position in any of the stocks mentioned. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. ESTA Founder Sells $7.9M on Earnings Day — Here's Why that's Not the Story was originally published by The Motley Fool

Investor releaseQuarter not tagged2026-05-08

Analysts Have Made A Financial Statement On Establishment Labs Holdings Inc.'s (NASDAQ:ESTA) First-Quarter Report

Simply Wall St.
It's been a good week for Establishment Labs Holdings Inc. (NASDAQ:ESTA) shareholders, because the company has just released its latest quarterly results, and the shares gained 5.0% to US$72.03. The results don't look great, especially considering that statutory losses grew 27% toUS$0.45 per share. Revenues of US$60m did beat expectations by 4.3%, but it looks like a bit of a cold comfort. The analysts typically update their forecasts at each earnings report, and we can judge from their estimates whether their view of the company has changed or if there are any new concerns to be aware of. Readers will be glad to know we've aggregated the latest statutory forecasts to see whether the analysts have changed their mind on Establishment Labs Holdings after the latest results. AI is about to change healthcare. These 20 stocks are working on everything from early diagnostics to drug discovery. The best part - they are all under $10bn in marketcap - there is still time to get in early. After the latest results, the nine analysts covering Establishment Labs Holdings are now predicting revenues of US$267.4m in 2026. If met, this would reflect a decent 16% improvement in revenue compared to the last 12 months. Losses are supposed to decline, shrinking 15% from last year to US$1.27. Before this latest report, the consensus had been expecting revenues of US$265.2m and US$1.10 per share in losses. So it's pretty clear the analysts have mixed opinions on Establishment Labs Holdings even after this update; although they reconfirmed their revenue numbers, it came at the cost of a notable increase in per-share losses. View our latest analysis for Establishment Labs Holdings The consensus price target held steady at US$89.89, seemingly implying that the higher forecast losses are not expected to have a long term impact on the company's valuation. The consensus price target is just an average of individual analyst targets, so - it could be handy to see how wide the range of underlying estimates is. There are some variant perceptions on Establishment Labs Holdings, with the most bullish analyst valuing it at US$100.00 and the most bearish at US$76.00 per share. Even so, with a relatively close grouping of estimates, it looks like the analysts are quite confident in their valuations, suggesting Establishment Labs Holdings is an easy business to forecast or the the analysts are a…Read full document

It's been a good week for Establishment Labs Holdings Inc. (NASDAQ:ESTA) shareholders, because the company has just released its latest quarterly results, and the shares gained 5.0% to US$72.03. The results don't look great, especially considering that statutory losses grew 27% toUS$0.45 per share. Revenues of US$60m did beat expectations by 4.3%, but it looks like a bit of a cold comfort. The analysts typically update their forecasts at each earnings report, and we can judge from their estimates whether their view of the company has changed or if there are any new concerns to be aware of. Readers will be glad to know we've aggregated the latest statutory forecasts to see whether the analysts have changed their mind on Establishment Labs Holdings after the latest results. AI is about to change healthcare. These 20 stocks are working on everything from early diagnostics to drug discovery. The best part - they are all under $10bn in marketcap - there is still time to get in early. After the latest results, the nine analysts covering Establishment Labs Holdings are now predicting revenues of US$267.4m in 2026. If met, this would reflect a decent 16% improvement in revenue compared to the last 12 months. Losses are supposed to decline, shrinking 15% from last year to US$1.27. Before this latest report, the consensus had been expecting revenues of US$265.2m and US$1.10 per share in losses. So it's pretty clear the analysts have mixed opinions on Establishment Labs Holdings even after this update; although they reconfirmed their revenue numbers, it came at the cost of a notable increase in per-share losses. View our latest analysis for Establishment Labs Holdings The consensus price target held steady at US$89.89, seemingly implying that the higher forecast losses are not expected to have a long term impact on the company's valuation. The consensus price target is just an average of individual analyst targets, so - it could be handy to see how wide the range of underlying estimates is. There are some variant perceptions on Establishment Labs Holdings, with the most bullish analyst valuing it at US$100.00 and the most bearish at US$76.00 per share. Even so, with a relatively close grouping of estimates, it looks like the analysts are quite confident in their valuations, suggesting Establishment Labs Holdings is an easy business to forecast or the the analysts are all using similar assumptions. Of course, another way to look at these forecasts is to place them into context against the industry itself. It's clear from the latest estimates that Establishment Labs Holdings' rate of growth is expected to accelerate meaningfully, with the forecast 23% annualised revenue growth to the end of 2026 noticeably faster than its historical growth of 11% p.a. over the past five years. By contrast, our data suggests that other companies (with analyst coverage) in a similar industry are forecast to grow their revenue at 8.0% per year. It seems obvious that, while the growth outlook is brighter than the recent past, the analysts also expect Establishment Labs Holdings to grow faster than the wider industry. The most important thing to take away is that the analysts increased their loss per share estimates for next year. Fortunately, they also reconfirmed their revenue numbers, suggesting that it's tracking in line with expectations. Additionally, our data suggests that revenue is expected to grow faster than the wider industry. There was no real change to the consensus price target, suggesting that the intrinsic value of the business has not undergone any major changes with the latest estimates. Following on from that line of thought, we think that the long-term prospects of the business are much more relevant than next year's earnings. We have estimates - from multiple Establishment Labs Holdings analysts - going out to 2028, and you can see them free on our platform here. Before you take the next step you should know about the 1 warning sign for Establishment Labs Holdings that we have uncovered. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) simplywallst.com. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.

Investor releaseQuarter not tagged2026-05-08

Establishment Labs Holdings Inc (ESTA) Q1 2026 Earnings Call Highlights: Strong Revenue Growth ...

GuruFocus.com
This article first appeared on GuruFocus. Release Date: May 06, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Establishment Labs Holdings Inc (NASDAQ:ESTA) reported a strong start to 2026 with $59.9 million in revenue, marking a 45% growth over Q1 2025. The U.S. business showed exceptional performance with a 216% revenue growth over Q1 2025, driven by the successful launch of the Motiva platform. The company's minimally invasive platform generated $9.1 million in revenue, indicating strong market acceptance. Gross margin improved by 350 basis points to 70.7%, reflecting operational efficiency and higher-margin product sales. Establishment Labs Holdings Inc (NASDAQ:ESTA) raised its full-year revenue guidance to $266.5 million to $268.5 million, up from the previous range of $264 million to $266 million, demonstrating confidence in continued growth. Despite strong growth, the company remains cautious due to geopolitical uncertainties and is conservative in its business forecasts. SG&A expenses increased by $3.9 million, primarily due to higher sales-related costs and foreign exchange impacts. Cash decreased by $7.5 million during the quarter, driven by investments in the U.S. market, indicating ongoing financial pressures. The company has not yet finalized a long-term agreement with its silicone supplier, Nusil, which could impact future cost structures. The minimally invasive platform, while promising, is still in early stages of adoption in the U.S., and its long-term impact on market share remains uncertain. Warning! GuruFocus has detected 4 Warning Signs with ESTA. Is ESTA fairly valued? Test your thesis with our free DCF calculator. Q: How much of the U.S. growth is attributed to new accounts versus the Preservay launch? A: The U.S. progress has exceeded expectations, driven by expanding the Motiva business and increasing account utilization. Preservay is expected to be a significant future driver due to its patient benefits like minimal anesthesia and quicker recovery. Unidentified_6 Q: How is the minimally invasive platform, particularly Preservay, impacting the traditional Motiva business? A: The minimally invasive platform is complementary to the traditional Motiva business. Preservay and MIA are expanding the market by attracting new patients who were not considering breast augmentation befo…Read full document

This article first appeared on GuruFocus. Release Date: May 06, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Establishment Labs Holdings Inc (NASDAQ:ESTA) reported a strong start to 2026 with $59.9 million in revenue, marking a 45% growth over Q1 2025. The U.S. business showed exceptional performance with a 216% revenue growth over Q1 2025, driven by the successful launch of the Motiva platform. The company's minimally invasive platform generated $9.1 million in revenue, indicating strong market acceptance. Gross margin improved by 350 basis points to 70.7%, reflecting operational efficiency and higher-margin product sales. Establishment Labs Holdings Inc (NASDAQ:ESTA) raised its full-year revenue guidance to $266.5 million to $268.5 million, up from the previous range of $264 million to $266 million, demonstrating confidence in continued growth. Despite strong growth, the company remains cautious due to geopolitical uncertainties and is conservative in its business forecasts. SG&A expenses increased by $3.9 million, primarily due to higher sales-related costs and foreign exchange impacts. Cash decreased by $7.5 million during the quarter, driven by investments in the U.S. market, indicating ongoing financial pressures. The company has not yet finalized a long-term agreement with its silicone supplier, Nusil, which could impact future cost structures. The minimally invasive platform, while promising, is still in early stages of adoption in the U.S., and its long-term impact on market share remains uncertain. Warning! GuruFocus has detected 4 Warning Signs with ESTA. Is ESTA fairly valued? Test your thesis with our free DCF calculator. Q: How much of the U.S. growth is attributed to new accounts versus the Preservay launch? A: The U.S. progress has exceeded expectations, driven by expanding the Motiva business and increasing account utilization. Preservay is expected to be a significant future driver due to its patient benefits like minimal anesthesia and quicker recovery. Unidentified_6 Q: How is the minimally invasive platform, particularly Preservay, impacting the traditional Motiva business? A: The minimally invasive platform is complementary to the traditional Motiva business. Preservay and MIA are expanding the market by attracting new patients who were not considering breast augmentation before. This is expected to drive category growth. Unidentified_6 Q: Can Preservay become the standard of care over traditional breast augmentation in the U.S.? A: Minimally invasive procedures like Preservay have the potential to become standard due to their benefits, such as smaller scars and quicker recovery. The innovation with unique implants is beneficial for these procedures, and this is just the starting point for us. Unidentified_6 Q: Has the Preservay launch increased the conversion of accounts that hadn't adopted Motiva? A: While it's early in the U.S. launch, the minimally invasive platform has brought new accounts in Western Europe. We expect a similar trend in the U.S., potentially driving account acquisition. Unidentified_6 Q: What are the macroeconomic impacts, particularly concerning the Middle East and consumer behavior? A: The Middle East represents 5% of total sales, and while there were no orders in Q1, we expect shipments in Q2. Globally, we haven't seen an impact on demand for procedures, and costs like silicone are locked in for the year. Unidentified_6 and Unidentified_12 For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Investor releaseQuarter not tagged2026-05-07

Establishment Labs Holdings Inc. Q1 2026 Earnings Call Summary

Moby
Achieved 45% revenue growth in Q1 2026, driven by a 216% surge in U.S. revenue as the Motiva launch gains significant momentum among high-volume surgeons. Realized the third consecutive quarter of positive adjusted EBITDA, demonstrating operational leverage and a clear path toward becoming cash flow positive by the second half of 2026. Expanded gross margins by 350 basis points to 70.7%, primarily due to the higher-margin U.S. direct business and the premium pricing of the minimally invasive platform. Successfully launched the Preserve minimally invasive platform in the U.S., surpassing the full-year surgeon certification goal within the first quarter due to exceptional demand. Maintained a strong technology moat through a robust IP portfolio and clinical data showing device-related complication rates of less than 1%, significantly lower than industry competitors. A survey of 94 patients showed that 15% were new to the breast augmentation category, suggesting the minimally invasive platform is actively expanding the total addressable market. Strengthened the balance sheet through a debt refinancing with Oaktree, providing enhanced financial flexibility and liquidity to support ongoing commercial expansion. Raised full-year 2026 revenue guidance to a range of $266.5 million to $268.5 million, reflecting strong Q2 weekly order highs in the U.S. market. Increased 2026 revenue expectations for the minimally invasive business to over $35 million, up from the previous $30 million target, based on rapid surgeon adoption. Anticipates U.S. revenue will exceed 30% of total annual revenue in 2026, up from approximately 22% in the prior year. Assumes a transition to cash flow positive status in the second half of 2026, supported by improved working capital efficiency and PIK interest benefits of over $5 million per quarter. Planning for significant future growth drivers including U.S. breast reconstruction approval, the launch of the GEM gluteal solution, and expansion into the Canadian market. Exposure to the Middle East remains limited at less than 5% of total revenue, though management is monitoring potential macro impacts on global demand and freight costs. Secured 2026 silicone supply volumes and pricing with NuSil, with active negotiations underway for a long-term partnership exceeding five years. Expects Q2 cash usage to be higher than Q1 due to a final $4.7 mill…Read full document

Achieved 45% revenue growth in Q1 2026, driven by a 216% surge in U.S. revenue as the Motiva launch gains significant momentum among high-volume surgeons. Realized the third consecutive quarter of positive adjusted EBITDA, demonstrating operational leverage and a clear path toward becoming cash flow positive by the second half of 2026. Expanded gross margins by 350 basis points to 70.7%, primarily due to the higher-margin U.S. direct business and the premium pricing of the minimally invasive platform. Successfully launched the Preserve minimally invasive platform in the U.S., surpassing the full-year surgeon certification goal within the first quarter due to exceptional demand. Maintained a strong technology moat through a robust IP portfolio and clinical data showing device-related complication rates of less than 1%, significantly lower than industry competitors. A survey of 94 patients showed that 15% were new to the breast augmentation category, suggesting the minimally invasive platform is actively expanding the total addressable market. Strengthened the balance sheet through a debt refinancing with Oaktree, providing enhanced financial flexibility and liquidity to support ongoing commercial expansion. Raised full-year 2026 revenue guidance to a range of $266.5 million to $268.5 million, reflecting strong Q2 weekly order highs in the U.S. market. Increased 2026 revenue expectations for the minimally invasive business to over $35 million, up from the previous $30 million target, based on rapid surgeon adoption. Anticipates U.S. revenue will exceed 30% of total annual revenue in 2026, up from approximately 22% in the prior year. Assumes a transition to cash flow positive status in the second half of 2026, supported by improved working capital efficiency and PIK interest benefits of over $5 million per quarter. Planning for significant future growth drivers including U.S. breast reconstruction approval, the launch of the GEM gluteal solution, and expansion into the Canadian market. Exposure to the Middle East remains limited at less than 5% of total revenue, though management is monitoring potential macro impacts on global demand and freight costs. Secured 2026 silicone supply volumes and pricing with NuSil, with active negotiations underway for a long-term partnership exceeding five years. Expects Q2 cash usage to be higher than Q1 due to a final $4.7 million Benelux acquisition payment and seasonal short-term incentive payouts. Potential inclusion in the Russell 2000 index following the April 30th rank date is expected to increase institutional interest and benchmarking. Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Management clarified that the minimally invasive platform is complementary; 15% of Preserve patients were not previously considering surgery, indicating market expansion. In international markets, all Mia accounts also offer Preserve, demonstrating a 'good, better, best' portfolio approach that captures different price points and patient goals. U.S. order growth saw a 30% increase in average daily orders since the end of Q4, driven by both new account onboarding and increased utilization from existing surgeons. The Preserve launch is expected to accelerate account acquisition as surgeons seek to offer the latest minimally invasive techniques to meet patient demand. Current year costs are locked in, and long-term negotiations with NuSil are focused on co-development and exclusivity rather than just volume-based pricing. Management expressed high confidence in the 15-year partnership, noting that Establishment Labs is becoming an increasingly valuable customer to the supplier. Current 2026 guidance does not assume a specific timeline for FDA approval of the reconstruction indication, though it represents a doubling of the addressable market. Future approval is expected to further enhance the margin profile as it will be sold through the high-margin U.S. direct sales channel. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here.

Investor releaseQuarter not tagged2026-05-06

Establishment Labs Reports First Quarter 2026 Financial Results

Business Wire
NEW YORK, May 06, 2026--(BUSINESS WIRE)--Establishment Labs Holdings Inc. (NASDAQ: ESTA), a global medical technology company dedicated to improving women’s health and wellness, principally in breast aesthetics and reconstruction, today announced financial results for the first quarter ended March 31, 2026. First Quarter Highlights and Outlook (Unaudited) Revenue of $59.9 million, up 44.7% from Q1 2025, with guidance raised to $266.5 million to $268.5 million $19.6 million of Motiva sales in the United States, up 13.3% from Q4 2025 Minimally invasive revenue of $9.1 million for the quarter Gross margin of 70.7% compared to 67.2% in the year-ago period Loss from operations was $6.5 million compared to a loss of $16.9 million in the year-ago period Adjusted EBITDA income of $1.2 million compared to a loss of $12.1 million in the year-ago period Cash use $7.5 million compared to use of $21.2 million in the year-ago period Cash balance of $68.1 million as of March 31, 2026 "Our momentum is accelerating across both the United States and OUS (outside of the U.S.) markets," said Peter Caldini, Chief Executive Officer. "The U.S. launch of our minimally invasive platform is off to a strong start and is contributing meaningfully to our growth; we now expect it to make up at least 13% of 2026 revenue, up from previous guidance. At the same time, we’ve delivered our third consecutive quarter of positive adjusted EBITDA, underscoring the strength of our execution and the operational leverage inherent to this business." "Our first quarter performance gives us confidence to raise our annual guidance," said Sandra Harris, Chief Financial Officer of Establishment Labs. "Our recent refinancing with Oaktree extends our debt maturity and further enhances our financial flexibility. We expect to be free cash flow positive in the second half of the year and are focused on meaningfully increasing earnings per share every year moving forward." First Quarter 2026 Financial Results (Unaudited) Total revenue for the quarter ended March 31, 2026 was $59.9 million, compared to $41.4 million for the same period in 2025, representing a growth of approximately 44.7%, with Motiva U.S. revenue increasing to $19.6 million from $6.2 million in the prior-year period. Gross profit for the first quarter of $42.3 million, or 70.7% of revenue, increased compared to $27.8 million, or 67.2% of revenue…Read full document

NEW YORK, May 06, 2026--(BUSINESS WIRE)--Establishment Labs Holdings Inc. (NASDAQ: ESTA), a global medical technology company dedicated to improving women’s health and wellness, principally in breast aesthetics and reconstruction, today announced financial results for the first quarter ended March 31, 2026. First Quarter Highlights and Outlook (Unaudited) Revenue of $59.9 million, up 44.7% from Q1 2025, with guidance raised to $266.5 million to $268.5 million $19.6 million of Motiva sales in the United States, up 13.3% from Q4 2025 Minimally invasive revenue of $9.1 million for the quarter Gross margin of 70.7% compared to 67.2% in the year-ago period Loss from operations was $6.5 million compared to a loss of $16.9 million in the year-ago period Adjusted EBITDA income of $1.2 million compared to a loss of $12.1 million in the year-ago period Cash use $7.5 million compared to use of $21.2 million in the year-ago period Cash balance of $68.1 million as of March 31, 2026 "Our momentum is accelerating across both the United States and OUS (outside of the U.S.) markets," said Peter Caldini, Chief Executive Officer. "The U.S. launch of our minimally invasive platform is off to a strong start and is contributing meaningfully to our growth; we now expect it to make up at least 13% of 2026 revenue, up from previous guidance. At the same time, we’ve delivered our third consecutive quarter of positive adjusted EBITDA, underscoring the strength of our execution and the operational leverage inherent to this business." "Our first quarter performance gives us confidence to raise our annual guidance," said Sandra Harris, Chief Financial Officer of Establishment Labs. "Our recent refinancing with Oaktree extends our debt maturity and further enhances our financial flexibility. We expect to be free cash flow positive in the second half of the year and are focused on meaningfully increasing earnings per share every year moving forward." First Quarter 2026 Financial Results (Unaudited) Total revenue for the quarter ended March 31, 2026 was $59.9 million, compared to $41.4 million for the same period in 2025, representing a growth of approximately 44.7%, with Motiva U.S. revenue increasing to $19.6 million from $6.2 million in the prior-year period. Gross profit for the first quarter of $42.3 million, or 70.7% of revenue, increased compared to $27.8 million, or 67.2% of revenue, for the same period in 2025. The improvement in gross profit margin was primarily driven by geographic and channel mix. Total operating expenses for the first quarter were $48.8 million, $4.0 million higher compared to $44.8 million in the first quarter of 2025. This represents a 8.9% increase supporting a 44.7% growth of revenue, showing our ability to leverage operating expenses as we scale the business. Net loss for the first quarter was $13.4 million, compared to a net loss of $20.7 million in the year-ago period. Adjusted EBITDA increased by $13.3 million to an income of $1.2 million compared to a loss of $12.1 million in the year-ago period, achieving our third consecutive quarter of positive adjusted EBITDA. The Company’s cash balance on March 31, 2026 was $68.1 million. Fiscal 2026 Outlook The Company raises guidance based on the first-quarter 2026 performance, and expects the following results: Revenue: $266.5 million to $268.5 million, up from our previous range of $264 million to $266 million. Minimally invasive business to exceed $35 million in 2026 up from the previous guidance of $30 million Gross margin: 71.2% to 72.2% Operating expenses: $195 million to $200 million Adjusted EBITDA: Positive every quarter Free cash flow positive in the second half of the year Conference Call and Webcast Information Establishment Labs will host a conference call and webcast today at 8:30 a.m. Eastern Time to discuss its financial results. To participate in the conference call, Dial: 877-407-8037 (US & Canada) or +1 201-689-8037 (international). The call will also be available via live or archived webcast on the "Investor Relations" section of the Establishment Labs website at www.establishmentlabs.com. About Establishment Labs Establishment Labs Holdings Inc. is a global medical device company dedicated to improving women’s health and wellness in breast aesthetics and reconstruction through the power of science, engineering, and technology. The company offers a portfolio of solutions for breast health, breast aesthetics, and breast reconstruction in over 100 countries. With five million Motiva® devices delivered to plastic and reconstructive surgeons since 2010, the company’s products have created a new standard for safety and patient satisfaction. The company’s minimally invasive platform consists of Mia Femtech®, a unique minimally invasive experience for breast harmonization, and Preservé™, a breast tissue preserving and minimally invasive technology for primary breast augmentation and primary mastopexy augmentation. GEM® is a next generation minimally invasive system for gluteal ergonomic modeling currently undergoing an IRB approved pivotal study. The Motiva Flora® tissue expander is used to improve outcomes in breast reconstruction following breast cancer and is the only regulatory-approved expander in the world with an integrated port using radio-frequency technology that is MRI conditional. Zensor™ is an RFID technology platform used to safely identify implantable devices from outside the body, and includes the company’s first biosensor Zen™, currently part of an IRB approved pivotal study to measure core breast temperature. These solutions are supported by over 200 patent applications in 20 separate patent families worldwide and over 100 scientific and clinical studies and publications in peer reviewed journals. Establishment Labs manufactures at two facilities in Costa Rica compliant with all applicable regulatory standards under ISO13485:2024 and FDA 21 CFR 820. Please visit our website for additional information at www.establishmentlabs.com. Non-GAAP Financial Measures To supplement our financial results presented in accordance with GAAP, this release includes the following measures defined by the Securities and Exchange Commission as non-GAAP financial measures: EBITDA and Adjusted EBITDA. These non-GAAP measures are not based on any comprehensive set of accounting rules or principles and should not be considered a substitute for, or superior to, financial measures calculated in accordance with GAAP, and may be different from non-GAAP measures used by other companies, limiting the usefulness of the measures for comparison with other companies. EBITDA is defined as net income or loss excluding: (1) interest income and expense; (2) provision for income taxes; and (3) depreciation and amortization. We consider EBITDA useful to an investor in evaluating and facilitating comparisons of our operating performance between periods by removing the impact of our capital structure (primarily interest expense) and asset base (primarily depreciation and amortization) from our operating results. We also present Adjusted EBITDA which includes additional adjustments for items such as other non-cash charges, gains or losses on extinguishment of debt, share-based compensation, contract termination costs, foreign currency gains and losses and restructuring costs. We believe that Adjusted EBITDA provides useful supplemental information to investors regarding our ongoing operating performance that, when considered with net income and EBITDA, is beneficial to an investor's understanding of our performance. We believe disclosure of this information is also useful to investors as it provides insight into the earnings that management uses to make strategic decisions. These non-GAAP financial measures should be considered along with, but not as alternatives to, net income or loss as prescribed by GAAP as a measure of our operating performance. EBITDA and Adjusted EBITDA do not represent cash generated from operating activities under GAAP and should not be considered as alternatives to cash flows from operations or any other operating performance measure prescribed by GAAP. These measures are not measures of our liquidity, nor are indicative of funds available to fund our cash needs. These measurements do not reflect cash expenditures for long-term assets and other items that have been and will be incurred. EBITDA and Adjusted EBITDA may include funds that may not be available for management’s discretionary use due to functional requirements to conserve funds for capital expenditures, property acquisitions, and other commitments and uncertainties. Please see "Reconciliation of EBITDA and Adjusted EBITDA" for a reconciliation of these measures to net income (loss), the most directly comparable financial measure. This release also includes information about our expectations regarding Adjusted EBITDA on a forward-looking basis. We have not provided a reconciliation of such forward-looking Adjusted EBITDA information because a reconciliation of such measure to our expected GAAP net income (loss) on a forward-looking basis is not available without unreasonable efforts. The timing or amount of various reconciling items that would impact the forward-looking expectations for this non-GAAP financial measure are uncertain, depend on various factors and cannot be reasonably predicted. Such unavailable information could be material to our results computed in accordance with U.S. GAAP. Forward-Looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"). You can find many (but not all) of these statements by looking for words such as "approximates," "believes," "expects," "anticipates," "estimates," "intends," "plans," "intends to," "would," "will," "may" or other similar expressions in this press release. Any statements that refer to projections of our future financial or operating performance, anticipated trends in our business, our goals, strategies, focus and plans, including related product development and commercialization and regulatory approvals, and other characterizations of future events or circumstances, including statements expressing general optimism about future operating results, related to the company’s performance are forward-looking statements. We claim the protection of the safe harbor contained in the Private Securities Litigation Reform Act of 1995. We caution investors that any forward-looking statements presented in this report, or that we may make orally or in writing from time to time, are expressions of our beliefs and expectations based on currently available information at the time such statements are made. Such statements are based on assumptions, and the actual outcome will be affected by known and unknown risks, trends, uncertainties, and factors that are beyond our control. Although we believe that our assumptions are reasonable, we cannot guarantee future performance, and some will inevitably prove to be incorrect. As a result, our actual future results and the timing of events may differ from our expectations, and those differences may be material. Factors, among others, that could cause actual results and events to differ materially from those described in any forward-looking statements include risks and uncertainties relating to: our ability to successfully, timely and cost-effectively develop, seek and obtain regulatory clearance for and commercialize our product offerings; the rate of adoption of our products by healthcare providers or other customers; the success of our marketing initiatives; the safe and effective use of our products; our ability to protect our intellectual property; our future expansion plans and capital allocation; our ability to expand upon and/or secure sources of credit or capital; our ability to develop and maintain relationships with qualified suppliers to avoid a significant interruption in our supply chains; our ability to attract and retain key personnel; our ability to scale our operations to meet market demands; the effect on our business of existing and new regulatory requirements; and other economic and competitive factors. These and other factors that could cause or contribute to actual results differing materially from our expectations include, among others, those risks and uncertainties discussed in the company's annual report on Form 10-K filed on February 27, 2026, which risks and uncertainties may be updated in the future in other filings made by the company with the Securities and Exchange Commission. The risks included in those documents are not exhaustive, and additional factors could adversely affect our business and financial performance. We operate in a very competitive and rapidly changing environment. New risk factors emerge from time to time, and it is not possible for us to predict all such risk factors, nor can we assess the impact of all such risk factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. We are not undertaking any obligation to update any forward-looking statements. Accordingly, investors should use caution in relying on past forward-looking statements, which are based on known results and trends at the time they are made, to anticipate future results or trends. View source version on businesswire.com: https://www.businesswire.com/news/home/20260506890846/en/ Contacts Investor/Media Contact: Malavika William [email protected]

Investor releaseQuarter not tagged2026-05-06

Establishment Labs Q1 Earnings Call Highlights

MarketBeat
Strong Q1 results and raised outlook: Establishment Labs reported Q1 revenue of $59.9 million and adjusted EBITDA of $1.2 million (third consecutive quarter of positive adjusted EBITDA), with revenue up 45% year-over-year and management raising full-year 2026 revenue guidance to $266.5–$268.5 million (≈26–27% growth). U.S. ramp and minimally invasive momentum: U.S. revenue surged to $19.6 million (up 216% YoY) as the company surpassed 1,700 U.S. accounts; the Preservé minimally invasive platform, launched in the U.S. in March, generated $9.1 million in Q1 and management now expects minimally invasive revenue to exceed $35 million in 2026. Refinancing and path to cash-flow positivity: Cash fell to $68.1 million after U.S. investments, the credit facility was increased to $265 million at an 8.75% rate with PIK options, and management expects to reach cash-flow positive in the second half of 2026 without the need for equity financing. Interested in Establishment Labs Holdings Inc.? Here are five stocks we like better. Establishment Labs (NASDAQ:ESTA) reported first-quarter 2026 revenue of $59.9 million and adjusted EBITDA of $1.2 million, marking what Chief Executive Officer Peter Caldini described as “a strong start to the year.” Revenue increased 45% versus the prior-year period, and the company posted its third consecutive quarter of positive adjusted EBITDA. Caldini said the U.S. business “continued to outperform” with revenue of $19.6 million, up 216% year over year and 13.3% sequentially, despite what management called a seasonally light quarter for breast augmentation and reconstruction. Outside the U.S., the company delivered about 15% growth, and its minimally invasive platform generated $9.1 million in quarterly revenue. → 3 Emerging Markets ETFs to Maximize Exposure to High-Potential Countries Gross margin improved 350 basis points to 70.7% from 67.2% in the first quarter of 2025. CFO Sandra Harris attributed the expansion primarily to “the increasing contribution of our higher margin U.S. business,” as well as the growing impact of the minimally invasive platform, which she said carries higher average selling prices and margins. SG&A expense rose to $43.6 million from $39.7 million a year earlier, driven by variable costs tied to higher sales—“including freight”—foreign exchange impacts, and continued investment in the U.S. business, Harris said. Ex…Read full document

Strong Q1 results and raised outlook: Establishment Labs reported Q1 revenue of $59.9 million and adjusted EBITDA of $1.2 million (third consecutive quarter of positive adjusted EBITDA), with revenue up 45% year-over-year and management raising full-year 2026 revenue guidance to $266.5–$268.5 million (≈26–27% growth). U.S. ramp and minimally invasive momentum: U.S. revenue surged to $19.6 million (up 216% YoY) as the company surpassed 1,700 U.S. accounts; the Preservé minimally invasive platform, launched in the U.S. in March, generated $9.1 million in Q1 and management now expects minimally invasive revenue to exceed $35 million in 2026. Refinancing and path to cash-flow positivity: Cash fell to $68.1 million after U.S. investments, the credit facility was increased to $265 million at an 8.75% rate with PIK options, and management expects to reach cash-flow positive in the second half of 2026 without the need for equity financing. Interested in Establishment Labs Holdings Inc.? Here are five stocks we like better. Establishment Labs (NASDAQ:ESTA) reported first-quarter 2026 revenue of $59.9 million and adjusted EBITDA of $1.2 million, marking what Chief Executive Officer Peter Caldini described as “a strong start to the year.” Revenue increased 45% versus the prior-year period, and the company posted its third consecutive quarter of positive adjusted EBITDA. Caldini said the U.S. business “continued to outperform” with revenue of $19.6 million, up 216% year over year and 13.3% sequentially, despite what management called a seasonally light quarter for breast augmentation and reconstruction. Outside the U.S., the company delivered about 15% growth, and its minimally invasive platform generated $9.1 million in quarterly revenue. → 3 Emerging Markets ETFs to Maximize Exposure to High-Potential Countries Gross margin improved 350 basis points to 70.7% from 67.2% in the first quarter of 2025. CFO Sandra Harris attributed the expansion primarily to “the increasing contribution of our higher margin U.S. business,” as well as the growing impact of the minimally invasive platform, which she said carries higher average selling prices and margins. SG&A expense rose to $43.6 million from $39.7 million a year earlier, driven by variable costs tied to higher sales—“including freight”—foreign exchange impacts, and continued investment in the U.S. business, Harris said. Excluding a one-time item, adjusted SG&A was $41.0 million, or 68.4% of revenue, which Harris said represented about 50 basis points of leverage year over year. R&D spending was $5.2 million, consistent with prior quarters. → The Real SpaceX Play: 5 Chip Stocks Powering the IPO Before It Launches Management emphasized accelerating U.S. adoption as a key driver. Harris noted that U.S. revenue represented 32.7% of total revenue in the quarter, up from 26.8% in the fourth quarter of 2025 and 15% in the first quarter of 2025. Caldini said the company recently surpassed 1,700 accounts in the U.S. and is seeing increased adoption from higher-volume surgeons, with “30% increase in average orders since the end of Q4.” On the call, he clarified that the order-growth comment was specific to the U.S. Establishment Labs officially launched its minimally invasive platform in the U.S. in March, led by Preservé. Caldini said demand was strong enough that, after initially training surgeons at the company’s Costa Rica campus, Establishment Labs began training in the U.S. as well to accelerate certification. The company certified more than 260 U.S. surgeons by the end of the first quarter, exceeding its prior goal of training 200 by the end of 2026, he said. → Tyson Foods' Total Returns: Tasty Treats for Income Investors? Caldini also pointed to early patient data from a survey of 94 Preservé patients three months post-surgery, reporting that 98% said they experienced minimal disruption to daily life and 95% said they were satisfied or extremely satisfied with results. He added that 15% of surveyed patients were new to the category and had not considered breast augmentation until learning about Preservé, while 84% said they were willing to pay a premium for the procedure’s benefits and 99% said they would choose it again. In response to analyst questions, Caldini said the U.S. growth is still primarily driven by base Motiva implant adoption and utilization within accounts, while adding that Preservé is expected to be a significant growth driver over time. He also said that in markets outside the U.S. where both Mia and Preservé are available, the two procedures have been “very complementary,” with Mia positioned as a more premium, more restrictive offering and Preservé described as more “day-to-day” and lower-priced than Mia. Caldini said Preservé has helped bring in new accounts in some of the company’s direct markets in Western Europe, and he expects a similar trend could develop in the U.S. as the launch progresses. Caldini highlighted several planned growth drivers, including expansion into U.S. breast reconstruction, which he said is “equal in size to the breast augmentation market.” He said the company submitted Motiva implants to the FDA for approval in primary and revision breast reconstruction in December 2025 and is progressing through the review process. Harris later said the company has made “no assumptions” about timing of FDA approval for reconstruction in its outlook. On product timing, Caldini said the company has had discussions with the FDA regarding approval requirements for the Motiva Ergonomix2 implant, but he does not see it as “a significant driver for us until probably around 2028.” Mia is not yet available in the U.S., while Preservé has recently been introduced domestically. Following first-quarter performance, management raised full-year 2026 revenue guidance to $266.5 million to $268.5 million, up from $264 million to $266 million. Harris said the updated range implies approximately 26% to 27% growth over 2025. The company expects its business outside the U.S. to grow in the single digits, while the U.S. is expected to exceed 30% of total revenue for the year, up from about 22% last year. For the minimally invasive business, Harris said first-quarter revenue of $9.1 million came in above expectations, and the company now expects minimally invasive revenue to exceed $35 million in 2026, up from its prior $30 million outlook. The company expects full-year gross margin of 71.2% to 72.2%, operating expenses of $195 million to $200 million, and adjusted EBITDA to be positive in each quarter of 2026. Harris added that the company expects second-quarter EBITDA to be approximately double first-quarter levels, even as operating expenses remain elevated due to U.S. investment. Cash and financing were also a focus. Harris said cash decreased $7.5 million during the quarter to $68.1 million, primarily due to investments in the U.S. market. Caldini said the company refinanced its credit facility and expects to reach cash flow positive in the second half of the year, while Harris said the company has “enough cash on hand to reach cash flow positive” and has “no needs or plans to do any type of equity financing.” Harris outlined expected near-term cash usage in the second quarter, including a final $4.7 million payment related to the Benelux acquisition, the timing of short-term incentive payouts, and continued U.S. commercial investments, partially offset by $6 million of proceeds from the recent debt refinancing. She also said the refinancing introduced PIK interest, which she expects to benefit cash performance in the back half of the year, describing “PIK interest of more than $5 million per quarter.” In response to a question on the new debt agreement, Harris said the facility increased from $225 million to $265 million drawn and carries an 8.75% interest rate, with the ability to use PIK. She characterized the net impact as “neutral to slightly up” when considering increased availability of funds, the lower interest rate, and use of PIK. Addressing macro conditions, Caldini said the company has not seen an impact on global procedure demand so far, though it is monitoring the environment. He noted the Middle East represents about 5% of total sales, and the company had no orders from the region in the first quarter but had orders in the system for the second quarter. Harris added that the company is seeing “some initial surcharges on outbound freight” but said it has been able to navigate those costs while holding margins; she also said silicone volumes are locked in under contract through year-end. Separately, Harris said the company believes it is well-positioned to qualify for inclusion in Russell indices based on current market capitalization, noting that April 30 marked the Russell reconstitution rank date, with final membership to be confirmed in the coming months. Establishment Labs Holdings Inc is a global medical technology company specializing in the design, development and manufacture of silicone gel breast implants for aesthetic and reconstructive surgery. The company's proprietary portfolio is built around patient-focused safety, customization and innovation, offering solutions intended to enhance surgical outcomes and support clinical traceability. The company's flagship products fall under the Motiva® brand, which includes a range of ergonomic and round breast implants featuring SilkSurface® texturing and an embedded Q Inside® Safety microtransponder for unique implant identification. The article "Establishment Labs Q1 Earnings Call Highlights" was originally published by MarketBeat.

TranscriptFY2026 Q12026-05-06

FY2026 Q1 earnings call transcript

Earnings source - 75 paragraphs
Operator

Good morning. Welcome to Establishment Labs' first quarter 2026 earnings call. At this time, all participants will be in listen-only mode. At the end of this call, we will open the line for a question and answer session, and instructions will follow at that time. As a reminder, today's call is being recorded. I will now turn the call over to Malavika William, Global Head of Corporate Communications and Marketing. Please go ahead.

Malavika William

Thank you, operator, and thank you everyone for joining us. With me today is Peter Caldini, our Chief Executive Officer, and Sandra Harris, our Chief Financial Officer. Following our prepared remarks, we'll take your questions. Before we begin, I would like to remind you that comments made by management during this call will include forward-looking statements within the meaning of federal securities law. These include statements of Establishment Labs' financial outlook and the company's plans and timing for product development and sales. These forward-looking statements are based on management's current expectations and involve risks and uncertainties.

Malavika William

For a discussion of the principal risk factors and uncertainties that may affect our performance or cause actual results to differ materially from these statements, I encourage you to review our most recent annual and quarterly reports on Form 10-K and Form 10-Q, as well as other SEC filings, which are available on our website at establishmentlabs.com. I'd also like to remind you that our comments may include certain non-GAAP financial measures with respect to our performance, including, but not limited to, sales results, which can be stated on a constant currency basis or EBITDA, which we disclose on an adjusted EBITDA basis. Reconciliations to comparable GAAP financial measures for non-GAAP measures, if available, may be found in today's press release, which is available on our website.

Malavika William

The content of this conference call contains time-sensitive information, accurate only as of the date of this live broadcast, May the 6th, 2026. Except as required by law, Establishment Labs undertakes no obligation to revise or otherwise update any statement to reflect events or circumstances after the date of this call. With that, it is my pleasure to turn the call over to Peter.

Peter Caldini

Good morning, and thank you for joining us. Q1 2026 was a strong start to the year, with $59.9 million in revenue and adjusted EBITDA of $1.2 million, representing revenue growth of 45% over Q1 2025. The U.S. business continued to outperform with $19.6 million of revenue, a growth of 216% over Q1 2025, and quarter-over-quarter growth of 13.3%. It's worth noting that Q1 is a seasonally light quarter for breast augmentation and reconstruction. To grow quarter-over-quarter is a testament to the strength and acceleration of our U.S. launch. Outside the U.S., we delivered 15% growth driven by strong execution on both our direct and distributor markets. Our minimally invasive platform is showing immense promise as well, generating $9.1 million in revenue in Q1.

Peter Caldini

At the same time, we had our third quarter of positive adjusted EBITDA. Our gross margin improved by 350 basis points in Q1 2026 to 70.7%, up from 67.2% in Q1 2025. We refinanced our credit facility and expect to reach cash flow positive in the second half of the year. Our increasing profitability is demonstrating the operational leverage in our business, as well as our ability to generate meaningful earnings per share in the coming years. We continue to be conservative as we forecast our business due to the geopolitical landscape as well as our hyper-focus on achieving and scaling a cash flowing positive business.

Peter Caldini

As such, we are raising our guidance to $266.5 million to $268.5 million, up from a previous range of $264 million-$266 million. Our confidence comes from the strong start we are having in Q2. We are setting new weekly highs in our U.S. order counts. We expect our growth to continue throughout 2027 as well. As we've mentioned on our prior calls, there is a good likelihood we may be included in several indices, beginning with the Russell 2000. As we're seeing increased interest from firms that benchmark to these indices, we thought it would be helpful to provide an overview for those being introduced to our company for the first time. The robust growth we reported this quarter is a reflection of our work since 2011.

Peter Caldini

Establishment Labs is a woman's health company focused on transforming breast aesthetics and reconstruction through innovation. Since the moratorium on breast implants in the U.S. was imposed in 1992, this category has seen very little meaningful innovation, and as a result, patient behavior, surgeon adoption, and overall market growth has remained relatively static. Establishment Labs was founded on the belief that a deep investment in science could fundamentally improve existing technology and provide better options for women. From the beginning, we reexamined every aspect of the breast implant, from surface technology to manufacturing, leveraging advances in material science, biomedical engineering, and device design. This work is reflected in a robust intellectual property portfolio with more than 200 patents issued and pending worldwide. In 2015, we brought on Dr. Robert Langer to lead our scientific advisory board.

Peter Caldini

Robert Langer is one of the most accomplished scientists of the 21st century, and his contributions are behind the founding of several prominent companies. His work at MIT continues to impact science at the highest levels. Our partnership resulted in a seminal paper for plastic surgery. Published in Nature Biomedical Engineering in 2021, this paper focused on breast implant surface technologies and highlighted that the four-micron surface, which was intentionally designed to enhance biocompatibility, consistently demonstrated low inflammation. These results explain how Motiva implants outperform the category. The U.S. FDA clinical trial matched both our research findings and clinical data from around the world and is, quite frankly, game-changing. All these data points show device-related complication rates at new industry lows, including capsular contracture rates of less than 1%.

Peter Caldini

To put this in perspective, the FDA trials for competitive products have device-related complications rates that are upward to 20%, and in some cases, the complication rates far exceed 20%. Perhaps most interesting is our extended global warranty data. With over 49,000 warranties sold and only 377 claims submitted, the resulting complication rate is less than 1%. We publish this data annually on our post-market surveillance report and are the only company in the industry that publicly shares this information, which you can find readily available on our company website. Fear of complications are one of the top barriers for patients when considering a breast augmentation. Having a product that has an outstanding safety profile helps to diminish that concern and provides extra peace of mind for both patients and surgeons.

Peter Caldini

Less complications leads to happy patients and more referrals, which is the lifeblood for any plastic surgery practice. The significant technology moat that has been established is enhanced by our R&D pipeline of continuous innovation. Not only do we believe that we can take a substantial majority of breast implant market in time, we also believe we can significantly expand the market from where it is today. That is best evidenced by the launch of our Motiva minimally invasive platform. We have two minimally invasive procedures in market right now, Mia and Preservé. A third is currently in development called GEM and is a revolutionary advancement for gluteal augmentation that should offer a safer, more predictable alternative to the Brazilian butt lift. Both Mia and Preservé are available outside the United States with a presence in more than 45 markets globally.

Peter Caldini

While Mia is not yet available in the U.S., we recently introduced Preservé to the U.S. market. Both are built on tissue-preserving practices, which Establishment Labs has pioneered, and they allow for the use of minimal anesthesia while preserving the patient's native breast tissue, nipple sensation, and chest muscles. Mia features the Motiva Ergonomix2 diamond-shaped implant, which has a unique shape that allows for greater projection than a conventional round implant as the shape creates more projection with less volume. It also includes a proprietary shell, which allows insertion through the smallest incision possible within the Motiva portfolio. These characteristics make for a true scarless breast augmentation done by a small incision in the underarm. This procedure is meant for patients looking for a subtle enhancement with one to two cup size increase.

Peter Caldini

Preservé can feature either the Motiva Ergonomix one or two implants and accommodates both primary breast augmentation and primary breast augmentation mastopexy, offering patients smaller scars tucked under the breast crease and allows for larger sizes to be used. The launch of minimally invasive techniques into any specialty almost always dramatically increases the market. For example, there were approximately 95,000 total knee arthroplasty procedures in 1991. Between 2000 and 2005, minimally invasive knee procedures became the standard, and by 2010, there were approximately 250,000 procedures annually. In 2025 alone, this number rose to approximately 1.3 million, an increase of close to 14x. This kind of growth exists in other major procedure types as well, such as LASIK eye surgery and fat reduction.

Peter Caldini

In the United States., our minimally invasive technologies command a premium over 2x higher than traditional breast augmentation. If our overseas growth is any indication, we can expect that minimal invasive will create significant market expansion and be a meaningful driver of growth. The value proposition for patients is well defined: smaller scars, minimal anesthesia, preservation of tissue and sensation, and a faster recovery, combined with the safety and performance benefits of Motiva. Our initial three-year study on Mia was published in the Aesthetic Surgery Journal in October 2025 and showed no device-related complications. Like our FDA trial data, this is game-changing. It's clear that this procedure is fundamentally different from what has come before. Many women no longer view this as the traditional breast augmentation they once knew, but rather as a more accessible, almost lunchtime procedure where they can return to normal social activities within hours.

Peter Caldini

Women that have never considered breast augmentation before are now getting the procedure, and we are expanding the market. RealSelf, a popular online platform for aesthetic patients, published last week that breast augmentation page views were up 45% from Q4, and that breast implant revision page views were up 89%, indicating that patients' interest in the category is surging. Not only do our patients benefit, our minimally invasive platform also has the potential to increase surgeon productivity, allowing surgeons to run two operating rooms, one where the patient is being prepped or the room is being cleaned, and the other where the surgeon is operating. We had one plastic surgeon that started surgery at 6:00 A.M., and by 10:30 A.M., he had completed 10 minimally invasive surgeries. Scheduling a minimally invasive procedure day like this can generate more than 2x additional revenue for a practice.

Peter Caldini

The introduction of our minimal invasive platform enhances the Motiva portfolio, creating a clear good, better, best framework. This allows the plastic surgeon to address a broader range of patient needs across the aesthetics outcomes, lifestyle consideration, and price points. This portfolio approach is not just about product breadth, it enables us to expand the category, increase procedure volumes, and drive higher value per procedure while giving surgeons the flexibility to tailor their solutions to each patient. Patients are now engaging with surgeons very differently than before. In a category where it was historically very unusual for patients to ask about implant brands, 78% of surgeons now report being asked for a brand by name, and in those cases, 93% of the time, that brand is Motiva. Now, just 18 months into our U.S. launch, we are seeing the next step.

Peter Caldini

Patients are not only asking for Motiva, they are actively seeking out surgeons who are trained in minimally invasive procedures. We expect to see a similar dynamic as we enter breast reconstruction in the U.S., an opportunity that is equal in size to the breast augmentation market. We submitted Motiva implants to the FDA for approval in primary and revision breast reconstruction in December 2025 and are currently progressing through the review process. I hope that reintroduction to our business was helpful and that the context explains our success to date. The U.S. remains the most important driver for our growth. Motiva continues to be one of the fastest launches in the history of breast aesthetics, and we continue to expand our footprint, recently surpassing 1,700 accounts.

Peter Caldini

We are seeing increased adoption from higher volume surgeons who have moved beyond initial evaluation and are now fully committed to Motiva. This is reflected in our order growth, where we have experienced 30% increase in average orders since the end of Q4. We officially launched our minimally invasive platform in the U.S. in March. The response has been exceptional. While we initially trained surgeons on Preservé in our campus in Costa Rica, early demand was so strong we began training in the U.S. as well. This has allowed us to train surgeons at a much faster rate. We have now certified more than 260 surgeons in the U.S. For context, our goal was to train 200 surgeons by the end of 2026. We soared past that number by the end of the first quarter.

Peter Caldini

Those trained have shown a strong intent to purchase, and we have seen relatively quick adoption with the first procedures being performed shortly after training. A surgeon in the Northeast recently shared that he began offering Preservé after being trained and promoted the procedure on social media. He now has 50 Preservé cases scheduled in Q2 at a 30% premium to his traditional breast augmentation price. Another surgeon in Southern California was thrilled that Preservé has completely changed her practice and that she is consistently seeing patients that had previously deferred surgery due to the concerns around anesthesia and recovery. When you remove historic barriers, you bring new patients into the market. A recent Preservé patient who is a Pilates instructor got her procedure done on a Saturday, went to dinner with friends that night, and was back teaching Pilates on Monday.

Peter Caldini

This kind of recovery is traditionally unheard of, and for the first time, patients are truly returning to normal activity with minimal downtime. In a recent survey conducted with 94 Preservé patients, three months post-surgery, 98% stated that they experienced minimal disruption to their daily lives, with 95% satisfied or extremely satisfied with the results. In addition, 15% of patients said they were new to the category and had not considered breast augmentation until they learned about Preservé. 84% of the Preservé patient survey said they were willing to pay a premium for the benefits of the procedure, with 99% saying that they would choose this procedure again. Outside the U.S., our business continues to perform well. We delivered approximately 15% growth with strong performance across our direct markets, which continues to be a major focus area for us.

Peter Caldini

Our minimally invasive platform continues to be a key driver for growth globally. It is interesting that surgeons generally view the two procedures as complements to each other, and all Mia accounts are offering Preservé, showcasing the value of a minimally invasive portfolio approach that provides patients options to meet their aesthetic goals. Preservé continues to attract surgeons to the overall Motiva portfolio. In our OUS markets, we are seeing strong growth across European direct markets, including the U.K., Germany, Nordics, and our newly acquired Benelux affiliate. Continued stabilization in Latin America was solid performance in Argentina due to the adoption of the Motiva minimally invasive platform, as well as steady demand across all our distributor markets. Our exposure to the Middle East remains less than 5% of total revenue, limiting risk from regional volatility.

Peter Caldini

In our U.S. and OUS markets, we expect growth to continue to accelerate into 2027. We also expect to continue the innovation pipeline by expansion in breast reconstruction in the U.S., which effectively doubles our addressable market, gaining CE mark for Zenº temperature, marking our entrance into biosensing capabilities, introducing smaller sizes to our U.S. product matrix, and thus expanding our reach within existing accounts, continue to develop our pipeline, including GEM, our gluteal augmentation solution. We also plan to submit for Health Canada medical device license for expansion in the Canadian market. As part of our overall strategy, we are taking steps to secure our future growth. This includes our signed agreement with Oaktree that refinances our debt and enhances our financial flexibility. Finally, we are in active conversations with NuSil, our silicone supplier, as we both look to establish a long-term agreement.

Peter Caldini

We've had strong working relationship with NuSil for the last 15 years, and our ongoing conversations are very focused on what we can accomplish together as partners. I will now turn the call over to Sandra.

Sandra Harris

Thank you, Peter. We delivered an exceptional start to 2026 with nearly 45% revenue growth, gross margin expansion over 70%, and our third consecutive quarter of positive adjusted EBITDA, demonstrating the strength, scalability, and operating leverage of our business. Total revenue for the first quarter was $59.9 million, an increase of 44.7% from Q1 2025. Starting with our geographic performance, our business outside the U.S. remains the largest contributor to revenue and continues to perform well. In the first quarter, OUS revenue grew approximately 15% over Q1 2025, driven by strength across our distributor and direct markets, with direct markets delivering double-digit growth. Our exposure to the Middle East remains limited at less than 5% of total annual revenue. In the U.S., we see strong momentum early in our expansion.

Sandra Harris

U.S. revenue reached $19.6 million in the quarter and now represents 32.7% of total revenue, up from 26.8% in Q4 2025 and higher than the 15% from Q1 of 2025. This growth reflects both continued adoption of Motiva and the March launch of our minimally invasive platform, which is contributing to higher realized price points. Our gross profit for the first quarter was $42.3 million, or 70.7% of revenue, a 350 basis point increase compared to 67.2% of revenue in Q1 of 2025. This expansion was primarily driven by the increasing contribution of our higher margin U.S. business, along with the growing impact of our minimally invasive platform, which carries higher average selling prices and margins.

Sandra Harris

SG&A expenses increased $3.9 million-$43.6 million compared to $39.7 million in the first quarter of 2025. The increase was primarily driven by variable costs associated with higher sales, including freight, as well as the impact of foreign exchange with continued investment in the U.S. business. Excluding a one-time item, adjusted SG&A was $41 million or 68.4% of revenue, representing approximately 50 basis points of leverage versus the prior year as we begin to scale the business. R&D expenses for the first quarter were $5.2 million consistent with prior quarters. Adjusted EBITDA was positive $1.2 million in the first quarter compared to a loss of $12.1 million in the first quarter of last year. This is our third consecutive quarter of positive adjusted EBITDA.

Sandra Harris

During the quarter, cash decreased $7.5 million-$68.1 million from December 31st, 2025. The decrease was primarily driven by investments in the U.S. market. We recently completed a refinancing of our debt, which enhances our financial flexibility, improves our liquidity profile, and introduces PIK interest that supports our path to cash flow generation. We have enough cash on hand to reach cash flow positive and have no needs or plans to do any type of equity financing. Following our strong performance in the first quarter, we are increasing our full year revenue guidance to $266.5 million-$268.5 million, up from our prior range of $264 million-$266 million. This represents growth of approximately 26%-27% over 2025.

Sandra Harris

We expect our OUS business to grow in the single digits, while the US is expected to exceed 30% of total revenue for the year, up from approximately 22% last year. At $9.1 million in the quarter, our minimally invasive business is above expectations, and we now expect to exceed $35 million in 2026, up from the $30 million we guided to in February. We expect gross margins in the range of 71.2%-72.2% for the full year. Operating expenses are expected to remain between $195 million and $200 million, with some variability in quarterly spending based on timing. We also expect to be adjusted EBITDA positive in each quarter of 2026.

Sandra Harris

As it relates to cash flow, we are on track to achieve cash flow positive in the second half of the year, driven by improved profitability and greater working capital efficiency. In the near term, we expect higher cash usage in the second quarter compared to the first quarter, primarily due to the final $4.7 million payment related to the Benelux acquisition, the normal timing of the short-term incentive payouts, and continued investment to support the U.S. commercial expansion, partially offset by $6 million of proceeds from our recent debt refinancing. We expect cash performance to improve meaningfully in the third and fourth quarters, supported by increased profitability and the benefit of PIK interest of more than $5 million per quarter. Historically, Q2 and Q4 are the strongest quarters in the industry, with Q4 being the largest, while Q3 is typically softer due to summer seasonality.

Sandra Harris

Operating expenses will be elevated in Q2 as we continue to invest in the U.S. business. Despite this, we expect Q2 EBITDA to be approximately double that of Q1, reflecting the underlying operating leverage in the business. With respect to index inclusion, April 30th marked the Russell reconstitution rank date, and based on our current market capitalization, we believe we are well-positioned to qualify for inclusion in the Russell indices, with final membership to be confirmed in the coming months. With that, I'll turn the call back to Peter.

Peter Caldini

Thank you, Sandra. As you think about our business, we hope we get a chance to interact with you at one of our many events we attend throughout the year. If you're interested in learning more, we selectively invite investors to visit us in Costa Rica at our innovation campus alongside our U.S. plastic surgeon delegations. Investors have found this trip very useful in validating our business and the overall opportunity. We're also hosting a small dinner in Boston around The Aesthetic Meeting from May 14th to May 17th. If you're interested in either of these, please reach out as space is limited. I appreciate you taking the time to listen, and I hope to see you on the next call soon. Operator, we're ready to take questions.

Operator

Thank you, sir. Ladies and gentlemen, we will now be conducting the question and answer session. Please note for participants making use of speaker equipment, it may be necessary to pick up your handset before pressing the star keys. If you'd like to ask a question, please key in star and then one on your telephone keypad. A confirmation tone will indicate that your line is in the question queue. You may key in star and then two to leave the question queue. We further request that you limit yourself to one question, and if time allows, you're welcome to rejoin the question queue for follow-up questions. Our first question comes from Anthony Petrone of Mizuho Group. Please go ahead.

Anthony Petrone

Thanks. Congratulations, Peter, Sandra, and to the team on a strong start to the year here. You know, maybe the U.S. momentum here, it looks like an inflection. You have really, you know, almost two simultaneous launches, if you will, ongoing. It's the U.S. Motiva platform in and of itself. There's still a push into new accounts. Of course, we have the Preservé launch. Maybe, you know, how much was just new accounts bringing in Motiva as a platform versus the Preservé go-live accounts? I mean, by our estimate, you know, you're probably approaching somewhere between 75 and 100, you know, go-live Preservé accounts. I'll start there, and I'll have a quick follow-up. Thanks.

Peter Caldini

Thanks, Anthony. As you highlighted, I mean, the progress in the U.S. has been tremendous. I mean, it's exceeded all our expectations. You see that with all the different metrics that we look at. I mean, we've increased the number of accounts. We continue to grow the base Motiva business. You know, a lot of that is driven. It shouldn't be a surprise. I mean, we've come to the market with what we believe to be the best implants from a performance as well as a safety standpoint, and we couple that with a best-in-class organization. That's really helping to drive that growth. You know, a lot of that currently is still based off of expanding and the Motiva business and getting into more accounts.

Peter Caldini

We're also driving utilization in the accounts that we're in. Clearly, Preservé will be a significant driver for us in the future. I mean, it's not a surprise as well. I mean, there's very clear patient benefits, you know, with minimal anesthesia, with smaller scars, quicker recovery. I think it's creating a lot of interest and excitement from a patient as well as a surgeon standpoint. We're seeing good growth opportunities just on our base as well as on the Preservé launch.

Operator

The next question comes from Josh Jennings of TD Cowen. Please go ahead.

Josh Jennings

Hi, good morning. Great to see the strong start to the year. I wanted to ask about the minimum invasive platform, follow-up to Anthony's question, and clearly gaining more and more traction. You know, love to just hear you build out more, Peter, on just how Preservé is not cannibalizing Motiva business or Motiva cases, but is actually, you know, incremental to kind of the traditional augmentation patient. Then maybe do the same for Preservé and Mia, and just help us understand how they may be complementary and how the Preservé launch internationally may be even boosting Mia traction as well.

Josh Jennings

If you could tie it all into just, it sound like you're optimistic that the breast implant market globally, especially in the United States, can actually see stronger growth here in the coming quarters, years, and then how this all ties in. Sorry for the multilayer question, but appreciate you taking it.

Peter Caldini

Thanks, Josh. You know, as you highlighted, you know, the minimally invasive platform, we're seeing a lot of very strong growth. When you look at our OUS markets, where we have both Mia and Preservé, what we've seen, and we've been very pleased to see this, is they operate very complementary. In all the accounts that we currently have, Mia, which is close to 150 accounts, we have Preservé. There's clear distinction between the two, where Mia is much more of in the premium segment, smaller scars to no scars. It's under the armpit. It's somewhat restrictive in terms of the number of or the type of patients and the type of surgeons that would use that.

Peter Caldini

While Preservé is much more day-to-day, it's a premium versus our base, it's less, lower priced than Mia. They work very complementary. What we've been able to see in a lot of markets in OUS is just with the minimally invasive rollout with Preservé as well as Mia, we've been able to expand our account base in a number of markets that's really helped to drive that. To answer your last question, We're seeing this, you know, with some of the market research that, you know, in the U.S. with Preservé, you know, 15% of women that have used the procedure were not currently considering breast augmentation.

Peter Caldini

We believe that the minimally invasive, you know, both Mia and Preservé has a real opportunity to drive category growth. You know, I think there is just increasing a lot more interest in the area of transparency with, not only with the Preservé and Mia, but as well as just more openness, and interest in breast augmentation, and we feel that we're a big part of that.

Operator

The next question comes from Sam Eiber of BTIG. Please go ahead.

Sam Eiber

Hi, good morning. Thanks for taking the questions here. Maybe I can stay on Preservé for a moment. You know, Peter, would love your thoughts on, you know, if you think Preservé can eventually become standard of care, you know, over traditional breast augmentation, at least here in the U.S. Maybe you can help explain why Preservé is something that, you know, beyond the tools, is something that can only be done with. Motiva, whether it's, you know, the implant surface, whether it's the low complication rates, would love if you can explain that in a little bit more detail. Thank you.

Peter Caldini

I mean, I think it, in terms of the minimally invasive and Preservé, not only in the U.S., but I think globally, it really makes sense. If you look at, like, different types of procedures, surgical procedures, everything is minimally invasive. I think bringing that technology and that capability, I think it's, you know, patients, that's what they're looking for. I mean, it's very clear what the benefits are for patients. You know, smaller scars, quicker recovery, minimal anesthesia, which is very important for a number of women. It really has the opportunity to be a significant growth driver, but it's the standard of care, I think, in the industry.

Peter Caldini

I think in some respects, because of the lack of innovation we've seen in the U.S. prior to our entry, I think, you know, a lot of the category is behind. We do believe that that's gonna be, you know, more standardized in the industry. I think it's really our innovation with the unique implants that we have is very specific and beneficial for this type of procedure. You know, we'll continue to look at and continue to drive innovation that really shapes the category, and I think this is just the starting point for us.

Operator

The next question comes from Mason Carrico of Stephens. Please go ahead.

Mason Carrico

Hey, guys. Thanks for taking the question here. I assume that most, if not all, Preservé users were already Motiva users, but was curious to hear if that launch has actually led to increased conversation or maybe even conversion of accounts that previously hadn't adopted Motiva. Maybe just a simpler way to the question is, do you think that launch could actually accelerate the onboarding of new accounts moving forward?

Peter Caldini

Yeah. Mason, I mean, we're pretty early in the launch, but what we've seen outside the U.S. is that the minimally invasive, specifically Preservé, has brought in a number of new accounts for us in our direct markets in Western Europe. It has had that benefit. You know, bringing new technology, bringing a new procedure, I think, has really resulted in, you know, our ability to drive account growth in a lot of our Western European markets. In the U.S., I mean, it's, you know, it's still early. I believe you're gonna see the same type of trend in the U.S., but, you know, we're kind of in month two right now and there's significant demands with the accounts that we do have, and You know, we're very focused on getting the training done. I do believe, to your question, I think it has the potential to drive, you know, certainly account acquisition.

Operator

The next question comes from Caitlin Roberts of Canaccord Genuity. Please go ahead.

Caitlin Roberts

Hi. Congrats on the quarter, and thanks so much for taking the questions. Just a quick one. Have you added all the reps that you plan to add for Preservé in the U.S.? Just appreciate the guidance on MIS, but could you break out potentially Preservé and Mia, and any updates on the timeline for you guys to bring Ergo2 into the U.S. and eventually Mia?

Peter Caldini

Thanks, Caitlin. The split between the Preservé and Mia, you know, a bulk of that is really driven by, you know, Preservé is the key driver for us. You know, we expect that to be a significant growth driver for us moving forward. You know, as it relates to Ergo2, I mean, currently we've had good discussions with the FDA. You know, we're trying to really align on what the appropriate regulatory requirements are for us to get that approved with the FDA. We don't see that as a significant driver for us until probably around 2028. I mean, we have a lot of growth opportunities as it relates to Preservé currently.

Peter Caldini

As you asked, I mean, we are expanding our sales force. Currently, we're at 50 reps, but we're gonna continue to expand that opportunistically when there's a geographical opportunity, but also more importantly, getting the right talent. You know, I think we've been very successful in what I consider to be a best-in-class organization and in this industry, bringing over high-quality sales reps that have the established relationship, and that makes a big impact, and we've been able to do that.

Operator

The next question comes from Joanne Wuensch of Citibank. Please go ahead.

Joanne Wuensch

Good morning, and thank you for taking the question. I've got a big picture one. What are you seeing in the macroeconomic environment? Specifically I'm concerned or thoughtful of the consumer and the impacts to the Middle East as it might relate either to sales or resin or oil prices or anything on the bigger landscape would be helpful. Thank you so much.

Peter Caldini

Yeah. Hi. Thanks, Joanne. I think that's a great question. I mean, obviously that's top of mind for, you know, anybody that's running a company. You know, I think, you know, as you look at what's going on in the Middle East, I think first off, just looking at the Middle East, as we highlight in the prepared remarks, it represents 5% of our total sales. You know, not surprising in Q1, we didn't have any orders. We do have orders in the system in Q2, we expect to be shipping to the Middle East this quarter. There is some demand there. I think the key question is what you highlighted. You know, what is the potential overall macro impact?

Peter Caldini

You know, so far, Joanne, we have not seen an impact on the global demand for the number of procedures. You know, that's something that we're gonna continue to closely monitor. As it relates to areas in terms of, you know, costs, I think we've seen some, and I can let Sandra answer this, but we've seen some impact in terms of outward freight. There has not been an impact in terms of our, you know, silicone costs, because those are locked in for the full year. I would say in general, we haven't seen a significant impact, but that's something we're gonna monitor very closely. Sandra?

Sandra Harris

Yeah. No, I think Peter hit it. We're seeing some initial surcharges on outbound freight, but at this time, we've been able to navigate through and, you know, hold our margin profile. Our silicone provider, we recently have, you know, locked in volumes, and we have a contract with them through the end of the year. We'll monitor the situation and look to protect our margins with any type of price as it progresses.

Operator

Thank you. The next question comes from Allen Gong of JPMorgan. Please go ahead.

Allen Gong

Hi, team. Thanks for the question. I just had a quick one on, you know, the guidance and just the momentum that you're seeing. You talked about how orders are up, you know, 30% from 4Q to 1Q. First quick one, is that a U.S. comment? Given that kind of momentum, how should we feel about, you know, the cadence for the balance of the year, and particularly what you're seeing in the second quarter, given the reiterated guide or, you know, guide by just the beat in the first quarter? Thank you.

Peter Caldini

Yeah. Allen, I'll kick it off. Just to clarify that, I mean, when we talk about the orders, that was specific to the U.S. You know, as we highlighted in the prepared remarks, we're increasing the number of accounts, but also we're increasing the utilization rate, you know, as the surgeons work through their schedule. It's a combination, and it's reflected in the average daily orders. We see very strong momentum going into Q2 as well. That's not just in the U.S. I think in overall, you know, globally, in a lot of markets, we've, you know, the demand has been stable.

Peter Caldini

I think the one outstanding question that we had going into as we're managing business, like a lot of different companies, is, you know, what's the impact of the Middle East? As I mentioned before, you know, it is a small part of our business. We do have orders in the system for Q2, so there is demand there. We have not seen the impact, you know, in terms of global demand, but that's something we're gonna monitor. Based on that, you know, gave us the comfort to raise the guidance. You know, we had a strong Q1, we're off to a good start in Q2, so that gave us the comfort around that.

Operator

The next question comes from Matt Taylor of Jefferies. Please go ahead.

Matt Taylor

Hi. Good morning. Thanks for taking the question. I wanted to follow up on the silicone supply comments. I know that this year the contract's set in stone, but could you address the potential for cost increases beyond that? Maybe give us an update on how negotiations are going and when we could expect an update.

Peter Caldini

Yeah. Thanks. Thanks, Matt. It's a good question. I mean, you know, we have a very good relationship with NuSil. I mean, it goes back for a number of years. You know, obviously, as we continue to grow as a company, we become, you know, a more valuable customer to NuSil. We've had very productive conversations with NuSil, and we consider them very good partners. In fact, that we've aligned or we agreed on volume commitments for this year, just about a month ago. You know, the prices are locked in for this year. We've made that commitment. Obviously, you know, that's an increase in volume versus last year.

Peter Caldini

We've started conversations around a long-term agreement and, you know, there's interest on the NuSil side to have an agreement as well as for us to have an agreement five years or more. A lot of the conversations are less about pricing. It's much more about, you know, co-development work. They're, you know, interested in exclusivity with us and looking at the length of the agreement. Generally around the price is more volume driven. The conversations are very productive. You know, as I mentioned before, we are, you know, continue to be a bigger part of their business. They've been good partners for us in the past, and we expect that to continue moving forward.

Peter Caldini

You know, we haven't finalized the conversation, the discussions on the agreement, but there's strong intent to have a very long-term agreement for with NuSil.

Operator

The next question comes from Mike Matson of Needham & Co. Please go ahead.

Mike Matson

Yeah, thanks. I just wanted to ask one on the refinancing. By our math, it seems like without the additional $35 million draw, there could be a slight increase in interest expense of maybe like $1 billion a year. Is that right? Thanks.

Sandra Harris

Thanks, Mike. Yes. On the new debt agreement, we've increased it from $225 million. The current draw is $265 million. There is a lower interest rate at 8.75%. There's the ability to PIK, which gives us some near-term, you know, cash availability, which we take. Net, net, there is, you know, neutral to slightly up on the increase in the availability of the funds with the lower interest rate and then the exercise of the PIK.

Operator

Thank you. The next question is a follow-up from Anthony Petrone of Mizuho Group. Please go ahead.

Anthony Petrone

Thanks. One for Sandra, just on gross margin here. Guidance 71.2% to 72.2%. How much of that is just, kind of reflection of Preservé at higher prices? Have you baked in an FDA clearance for reconstruction and just what that can bring to the table in terms of gross margin momentum? Thanks.

Sandra Harris

Yeah. Anthony, good question. Our gross margin improvement, and we do expect that it'll continue to contribute is the growth of the U.S. You know, with the U.S. business being a direct account, it improves our margin profile, and you're seeing that in our numbers. Obviously with OUS being further along in the journey on minimally invasive, its growth in the direct business, then the launch of minimally invasive in the U.S., that also is a big contributor to the margin. As we look forward, we do expect that we will continue to improve that margin based upon the mix of that business, both U.S. and OUS, as well as the minimally invasive. At this juncture, we do not, you know, we can't necessarily time the FDA approval, so we've made no assumptions in regard to reconstruction.

Operator

Thank you. Ladies and gentlemen, that is all the time we have for questions today. I will now turn the call back over to Peter Caldini for closing remarks.

Peter Caldini

Thank you, everybody, for joining the call this morning. You know, I appreciate the time and really having everybody get to hear more about the progress we're making with Establishment Labs. As we highlighted there, as I highlighted in the commentary, you know, it's a great opportunity. I hope to see you at some of the events, but also, you know, please take us up on the offer about visiting us in Costa Rica, and you really get an opportunity to really see the uniqueness of this company and the strengths that we have and just to build that partnership. Thanks again, everybody, for joining the call, and look forward to seeing you soon. Thank you.

Operator

Thank you, sir. Ladies and gentlemen, that concludes this event. Thank you for attending. You may now disconnect your lines.

As of 2026-08-08 • Updated weeklySource: Earnings sourceIngestion runbook