Establishment Labs Provides Preliminary First Quarter Results and Announces an Investor Day on June 12

Rhea-AI Summary

Establishment Labs Holdings (NASDAQ: ESTA) has released preliminary Q1 2025 results, expecting revenue of approximately $41.4 million, including $6.2 million from Motiva sales in the United States. The company maintains its 2025 revenue guidance of $205-210 million.

The US launch of Motiva is showing strong momentum, with March orders exceeding 100 per day. The company expects to achieve EBITDA positivity in 2025 and cash flow positivity in 2026, with anticipated tariffs having minimal impact (less than 50-basis points) on gross margins.

The company announced an upcoming investor day on June 12, 2025 in New York City, where leadership will present updates on the US Motiva launch, innovation roadmap, and financial outlook.

Positive

• Strong Motiva US launch with over 100 daily orders in March
• Maintained 2025 revenue guidance of $205-210 million
• EBITDA positive expected in 2025
• Cash flow positive projected for 2026
• Minimal tariff impact on gross margins (<50 bps)

Negative

• None.

Insights

Financial Analyst

Establishment Labs' preliminary Q1 revenue of $41.4 million, including $6.2 million from US Motiva sales, represents an important datapoint in their US commercialization journey. The US launch appears to be accelerating rapidly, with daily orders surpassing 100 in March - a pace management characterizes as "one of the fastest in aesthetic history."

The reaffirmation of full-year revenue guidance of $205-210 million demonstrates management confidence despite unspecified "recent events." This suggests the company's global expansion strategy remains on track. Particularly noteworthy is management's commentary that potential tariffs would impact gross margins by less than 50 basis points, proactively addressing investor concerns about trade policy impacts.

The company's projection to achieve EBITDA positive in 2025 and cash flow positive in 2026 provides a clear profitability roadmap. For medical device companies in expansion mode, these milestones represent crucial inflection points where revenue scale begins to overcome the heavy investment required for regulatory approvals and market entry. The upcoming June investor day will likely provide deeper visibility into these financial metrics and the company's longer-term margin structure.

Medical Device Industry Expert

Establishment Labs' US market entry appears to be gaining significant traction, with $6.2 million in Motiva breast implant sales reported for Q1. The accelerating daily order rate reaching 100+ in March suggests strong physician adoption - critical for aesthetic medical devices where individual practitioner preference heavily influences market penetration.

Beyond their core Motiva implants, ESTA is building a diversified aesthetic portfolio including Mia Femtech (minimally invasive breast harmonization), Preservé (tissue-preserving technology), GEM (gluteal modeling system), and integrated biosensor technology like Zenº. This multi-product strategy expands their addressable market while leveraging their existing physician relationships.

Their manufacturing capabilities in Costa Rica with ISO13485:2024 and FDA 21 CFR 820 compliance provide operational scalability to support this growth. The company's scientific foundation (100+ clinical studies and publications) offers competitive differentiation in a market where safety concerns have historically created barriers to new entrant success. The upcoming investor day will likely showcase their innovation pipeline and launch sequencing strategy, providing clearer visibility into their medium-term growth drivers beyond the initial US launch momentum.

NEW YORK--(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, provided preliminary first quarter 2025 sales results and announced that it will host an analyst and investor event in New York City on June 12, 2025.

Establishment Labs’ preliminary unaudited revenue for the first quarter of 2025 is expected to be approximately $41.4 million, including approximately $6.2 million from Motiva sales in the United States.

On June 12, Establishment Labs’ leadership team and invited plastic surgeons will present an update on the recent launch of Motiva in the United States, the company’s innovation roadmap, and the financial outlook. A live and archived webcast of presentations and Q&A sessions on June 12 will be available on the "Investors" section of the Establishment Labs website at www.establishmentlabs.com. In-person attendance at the event is limited and requires advanced registration. Please email: ir@establishmentlabs.com for further information.

“The second quarter appears strong, and the United States launch continues to accelerate,” said Peter Caldini, Establishment Labs’ Interim CEO. “Average orders in March surpassed 100 per day, and we expect this growth to continue, making our launch one of the fastest in aesthetic history. We have not seen any disruption to our business from recent events and affirm our previous commentary and guidance on revenue of $205 to $210 million for 2025. As currently contemplated, tariffs would represent less than a 50-basis point gross margin impact and do not change our trajectory of turning EBITDA positive in 2025 and cash flow positive in 2026. At our investor day, we look forward to providing an update on our United States launch as well as detailing our pipeline, timeline, and launch strategy for the additional products coming to market in the United States.”

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 90 countries. With over four 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 breast augmentation, revision augmentation and 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 28, 2025, 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/20250409937257/en/

Investor/Media Contact:

Raj Denhoy

415 828-1044

rdenhoy@establishmentlabs.com

Source: Establishment Labs Holdings Inc.

FAQ

What are Establishment Labs' (ESTA) projected revenue figures for Q1 2025?

ESTA expects preliminary Q1 2025 revenue of approximately $41.4 million, with $6.2 million coming from Motiva sales in the US.

What is ESTA's revenue guidance for full-year 2025?

The company maintains its 2025 revenue guidance of $205-210 million.

How is Motiva's US launch performing for ESTA in early 2025?

Motiva's US launch is accelerating with average daily orders exceeding 100 in March 2025, making it one of the fastest launches in aesthetic history.

When will ESTA achieve EBITDA and cash flow positivity?

ESTA expects to turn EBITDA positive in 2025 and achieve cash flow positivity in 2026.

What impact will tariffs have on ESTA's gross margins?

Tariffs are expected to have less than a 50-basis point impact on gross margins.