Establishment Labs Holdings (ESTA) Q2 2026 earnings call transcript

I will now turn the call over to Malavika William, VP, Global Head of Corporate Communications and Marketing. Please go ahead. 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 on 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. 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 6, 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, and 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 continue 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. As a result of our first-half performance, we are raising our full-year revenue guidance to $269 to $271 million, up from our previous range of $266.5 and $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. With our recent inclusion in the Russell 2000 Index, we have quite a bit of new interest in our story, and this was the 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 under-invested for years, and will 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, and 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 Preserve. 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 Preserve 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. Preserve A 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 United States, is designed for women seeking a more subtle enhancement, typically one to two cup size increase. The procedure uses our Ergonomics 2 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 Preserve. 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 Preserve 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 Preserve.

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 United States, Preserve 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 United States 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 Motiva implants in the U market in under 21 months since launch We are still early in our U journey but crossing 100 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 strengthened, 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 experiences 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. 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. Preserve 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 the 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. And we continue to see relatively quick adoption following certification. The benefits of Preserve are showing up across both traditional and digital media outlets.

In the limited time that Preserve 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 Magazine and Allure, as well as the ZO report and the Washington Post, to name a few. Surgeons report they are charging between 30% to 50% more for Preservate procedure than for their traditional breast augmentations, confirming that patients value these benefits and are willing to pay for them. It is increasingly early in the launch to see this kind of market expansion, and our success is suggestive that we are only in the early innings of something that could fundamentally change the category.

Also interesting, we are hearing from some surgeons that because of the very limited downtime with Preserve, they have book surgeries throughout the summer, which is unusual because the summer months are traditionally slower for breast augmentation. 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. Europe, where we have the most direct markets, delivered 16% growth and was especially strong in Italy, Germany, and the UK. 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 remain 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. 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.

Thank you, Peter. The second quarter was another important step forward financially. We continue 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 2025. 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 were $52 million for the quarter, including $2.2 million of one-time charges related to restructuring and debt refinancing.

excluding these charges, underlying operating expenses remain 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. 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 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 the softest quarter in the industry, reflecting the summer vacation period. We expect the U. S. business to remain strong, and our OUS business should reflect the normal seasonal pattern. 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, and the most important part of the business.

the growing contribution of our minimally invasive platform and the increasing profitability profile of establishment labs Now I turn the call back over to Peter Thank you Sandra As you heard today we continue to execute well across the business The U 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.

And, you know, NIA, as you highlighted, is just outside the U. S. We've had good traction. It's also, you know, a key driver for the development of Preserve. So part of this entire minimally invasive platform, you know, 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 Preserve. Outside the U. S. , similar type of numbers, because it does address a number of the barriers that are preventing women from, you know, doing a breast augmentation. And when you talk about minimal anesthesia, you talk about also those smaller scars and quicker recovery.

Yeah, so, Josh, so regarding GEM, you know, 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. So 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. And right now we're really working through what that regulatory pathway is going to be for the U. S. as well as OUF, primarily in Europe.

But we're very pleased with the progress we've made so far. I mean, it's a very differentiated technology. And, you know, we see this as very much an untapped market. But 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. But we're still working through what that regulatory pathway is going to be.

Yeah, thanks, Sam. I mean, it's pretty clear we're, you know, we're off to a great start with Preserve. There's significant demand. You know, I think our original target was around 200 surgeons. You know, we quickly surpass that. We're really expanding our capacity in terms of training. So there's no shortage of surgeons that are interested. What we're finding is that, you know, 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 of 2026, and, you know, this is really driven by tremendous demand in the marketplace, and, you know, it is addressing a significant barrier that patients have with doing a breast augmentation, And, you know, that's really been playing out in what we're seeing in the marketplace.

I guess any updated thoughts on how we should be thinking about that number? Yes, Sam, I think we said over $35 million, and what we said recently is that we're going to be approaching for the full year about 15% of our revenue. So, I think that depending on how you look at our guidance, that gives you the guide for the million-based going forward.

So we are seeing in the accounts, I mean, there's such strong interest in Preserve. It's truly a unique innovation in the marketplace that's really been starving for innovation. So, you know, there's really – we're seeing strong interest, and a number of surgeons are really – once they get trained and accustomed to using Preserve, you know, a lot of them see this as really the future of the industry, and it will continue to be a bigger part of the practice. It certainly generates a significant revenue opportunity for them.

So we see that over time that will continue to be a bigger part of that market. In terms of the split, I don't know that we've really talked about the split between the U. S. and the OUS, but 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. Your next question comes from the line of Caitlin Roberts from Canicor Genuity.

Yeah, thanks, Caitlin. You know, 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 and recon in the U. S. that we've experienced in augmentation. So 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. You know what I think is very positive they now started the BMO audits of our clinical study sites which I think is a normal part of the process and I think it a good indication that things are progressing well In terms of the actual approval timing I mean it really up to the FDA but what we seeing everything is positive moving in the right direction And just to remind everybody we don really expect from a planning standpoint to achieve material revenue and recon until 2027 Your next question comes from the line of Joanne Wunsch from Citi.

Yeah, so I'm not sure I fully heard the question. My understanding is what's our expectation in terms of the back half of the year? You know, listen, I think we're going to continue to see the strong momentum that we've experienced in the first half, you know, 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, and, you know, I think there's significant, you know, 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.

Yeah, 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 impacts 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 to 271. And then in regard to 2027, the only information we've provided to date is that we do expect that revenue next year would be around the 25% mark.

All right. So thanks, Anthony. In terms of Preserve, you know, 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. You know, as I mentioned previously, we're building out or expanding our capacity to do the training. So, you know, for us, I think that's going to be the surgeons that are using Preserve. It provides them a significant competitive advantage in the market, and I think that's where such a strong interest is. I mean, we've seen from market research that 15% of women who have done Preserve were not initially considering doing a breast augmentation until they heard about Preserve.

So it really has the potential to be a category driver and bring additional patients to the surgeon. So 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. You know, this clearly is a significant increase in terms of the ASP and the recon segment. It also really doubles our total addressable market in the U. S. So 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 be able to do that.

We have to go through that back process.

I mean, we've had, I think, very solid growth outside the U. S. , and a lot of that's been driven by our direct markets, in particular in Europe. You know, we've achieved 16% growth this quarter versus the same year, the same quarter last year, so very pleased with that. And that's very important for us because we prioritize those markets. These are our markets. We have better economics. We've made a number of leadership changes. We're also increasing the resources, and it's really reflected in terms of our performance. You know, what we're trying to do is de-emphasize our dependency on the distributors, and I think that's really been – we're really establishing that, and I think we've been very effective in doing it.

And specifically, I would say across most of our distributor markets, I think demand has been steady. But the one outlier is what you highlighted is the Middle East, you know, obviously with the conflict there. We have had orders, but it's at a much lower level than what we've experienced in the past. And we don't expect that to change for the remainder of the year. But this is, in terms of the spillover in other markets, we haven't really seen that, But we're going to continue to monitor that very closely and course-correct where necessary.

And Mike, this is a reminder. Middle East is less than 5% of our revenue.

Yeah, thanks, Alan, for the question. And 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, you know, basically we have leveraged our operating expense in relation to our sales growth. So, you know, single-digit growth in operating expenses with strong double-digit growth in revenue. As we look out, you know, 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. So, you know, 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, you know, leverage our expenses as we grow the business across the organization.

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. And 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. And as we work toward 2027, we'll provide more color on that based upon what we know from the FDA timing.

I will now turn the call over to Mr. Peter Maldini for closing comments. Thank you, Operator, and thank you, everybody, for joining the call today. Really appreciate the time. As you 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. So, 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.