Establishment Labs Holdings Inc. 2026 Q2 Earnings Call

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.