ESTA Establishment Labs Holdings Inc.

NASDAQ
$79.47

Establishment Labs Holdings Inc. Q2 F2026 Earnings Call Transcript

Thursday, August 6, 2026

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Peter Maldini
CEO
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 100,000 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 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 its 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 experiments 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 US 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 Zill Report and the Washington Post, to name a few. Surgeons report they are charging between 30% to 50% more for preservative 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 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. 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 US 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.
Sandra
CFO
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 up 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, 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 Maldini
CEO
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
Conference Call Moderator
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 recue. 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
TD Cowen Analyst
Hi, good morning, Peter and Sandra. Thanks for taking the questions and great to see another strong quarter, especially the U.S. momentum. Wanted to 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 meal ultimately could produce an entire new category in the aesthetic space where you could transition breast augmentation from a surgery to an injectable procedure. I mean, 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., and how does that all play out?
Peter Maldini
CEO
Yeah, thank you, Josh. You know, listen, I think what we've always highlighted around the minimally invasive platform, and this is truly an innovation in a category that hasn't seen innovation. 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. Thanks for that and I didn't know
Josh Jennings
TD Cowen Analyst
I'm focused on the pipeline here with my questions, but you referenced JEM 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 U.S. kind of commercial, OUS, excuse me, 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 Maldini
CEO
Yeah, so Josh, so 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. So where we are in that process, 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. 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.
Operator
Conference Call Moderator
Your next question comes from the line of Sam Iber from U.S. Bancorp. Please go ahead.
Sam Iber
U.S. Bancorp Analyst
Hi, good morning. Thanks for taking the questions here and congrats on the nice quarter. I want to come back to Preserve in the U.S., 300 surgeons now certified. I'm curious what you're hearing from the field in terms of utilization and adoption, their own plans to expand Preserve within their practice. and generally thoughts around the procedure and what it can mean for the U.S. business over the back half of the year.
Peter Maldini
CEO
Yeah, thanks, Sam. I mean, it's pretty clear we're off to a great start with Preserve. 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. So there's no shortage of 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. and 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 Iber
U.S. Bancorp Analyst
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 past 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
CFO
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. So I think that depending on how you look at our guidance, that gives you the guide for Million Basic going forward.
Sam Iber
U.S. Bancorp Analyst
Okay, great. Thanks for taking the questions.
Operator
Conference Call Moderator
Your next question comes from the line of Mason Carrico from Stephens. Your line is now open.
Mason Carrico
Stephens Analyst
Hey guys, thanks for taking the questions here. Could you give a sense of Motiva Mix among Preserve trained surgeons compared to that of an untrained one? Have you seen Preserve certification lift overall Motiva Mix or share it at that account? And I guess, you know, longer term, what percentage of your U.S. volumes do you think could ultimately be Preserve?
Peter Maldini
CEO
Yeah, so thanks. 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, Sandra.
Sandra
CFO
Yeah, I mean, in terms of the split, I don't know that we've really talked about the split between the U.S. and the O.U.S., 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.
Operator
Conference Call Moderator
Your next question comes from the line of Caitlin Roberts from Canaccord Genuity. Please go ahead.
Caitlin Roberts
Canaccord Genuity Analyst
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? And how many hospitals are you now in this Flora? Thank you.
Peter Maldini
CEO
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 that have the same level of success in recon in the US 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's a good indication that Things are progressing well. In terms of the actual approval timing, I mean, it's really up to the FDA. But what we're seeing, everything is positive, moving in the right direction. And just to remind everybody, we don't really expect from a planning standpoint to achieve material revenue and recon until 2027.
Operator
Conference Call Moderator
Your next question comes from the line of Joanne Wunsch from City. Your line is now open.
Caitlin Roberts
Canaccord Genuity Analyst
Hello, this is Jane Marie Lai. I'm for Joanne from City. Thanks for the question. How should we think about that and do you have any kind of color on that as well?
Peter Maldini
CEO
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 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
CFO
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 changes 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 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.
Operator
Conference Call Moderator
Your next question comes from the line of Anthony Petrone from Mizuho Financial Group. Please go ahead.
Anthony Petrone
Mizuho Financial Group Analyst
Thanks, and congrats on the strong print here. Maybe one on Preservate competitive dynamics and then pricing. Just on Preservey, when you think about site adoption in the U.S. specifically, one of the medtech phenomenons, for instance, with DaVinci Surgical, you sort of have DaVinci in your practice in the early days, and it represents a competitive advantage for that site. That site then gains share from its competitors. So to what extent do you think Preservey is going to allow surgeon sites to have competitive advantages versus its competitors. When do you think that tipping point actually happens? And then just on unit economics, can you remind us where Preserve sits per case versus Motiva? And when you think about reconstruction, how pricing will settle out there? Thanks.
Peter Maldini
CEO
All right. So thanks, Anthony. In terms of Preserve, as we highlighted, we're really in the early innings in the 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 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 before. 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. This clearly is a significant increase in terms of the ASP and the recon. 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 go through that back process.
Operator
Conference Call Moderator
Your next question comes from the line of Mike Mattson from Needham & Company. Please go ahead.
Mike Mattson
Needham & Company Analyst
Yeah, thanks. So, you know, I heard that the growth is kind of 4% outside the US, but I'm 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 Maldini
CEO
Yeah, so thanks, Mike. 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. 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. 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. 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, 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.
Sandra
CFO
And Mike, this is a reminder, Middle East is less than 5% of our revenues.
Operator
Conference Call Moderator
Your next question comes from the line of Alan Gong from JP Morgan. Please go ahead.
Alan Gong
J.P. Morgan Analyst
Thanks for the question. I guess just on the cost front, you know, when we look at your operating spend for the quarter, you know, excluding the refinancing costs came in better than expected. But 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 JEM. So how should we think about the trajectory of SG&A and R&D spend in the balance of the year?
Sandra
CFO
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 Thank you for joining us. 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
Conference Call Moderator
Your next question comes from the line of Matthew Taylor from Jefferies. Please go ahead.
Matthew Taylor
Jefferies Analyst
Good morning. Thanks for taking the question. I wanted to ask a follow-up on recon, and maybe I'll weave that into a 27 question. So 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. And 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
CFO
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.
Operator
Conference Call Moderator
There are no further questions at this time. I will now turn the call over to Mr. Peter Maldini for closing comments.
Peter Maldini
CEO
Thank you, operator, and thank you, everybody, for joining the call today. Really appreciate the time. You know, as you see, we're making a 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.
Operator
Conference Call Moderator
Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect.