Establishment Labs Q2 2026 Earnings Call Transcript

Quartr
Provided by Quartr
August 6, 2026

Key Takeaways

  • Positive Sentiment: Q2 revenue rose 31.7% year over year to $67.5 million, led by U.S. revenue growth of 140.9% to $24.7 million. Management raised full-year revenue guidance to $269 million-$271 million.
  • Positive Sentiment: U.S. adoption of Motiva continued to accelerate, surpassing 100,000 implants and 2,000 customer accounts in under 21 months. Increasing utilization within existing accounts and growing patient requests for Motiva are supporting momentum.
  • Positive Sentiment: The minimally invasive platform generated $12.1 million in Q2 revenue and is expected to approach 15% of full-year revenue. Preservé training exceeded expectations with more than 300 certified U.S. surgeons, while the company expects to train approximately 500 during 2026.
  • Positive Sentiment: Profitability and cash generation improved substantially, with gross margin expanding to 70.6% and adjusted EBITDA turning positive at $3.7 million versus a prior-year loss of $8.5 million. Management expects to become free-cash-flow positive in the second half of 2026 and for fiscal 2027, without needing additional equity raises.
  • Negative Sentiment: The third quarter is expected to reflect normal seasonal weakness, with the fourth quarter typically strongest. Middle East distributor demand has fallen because of regional conflict and is expected to remain depressed for the rest of the year, although the region represents less than 5% of revenue.
AI Generated. May Contain Errors.
Earnings Conference Call
Establishment Labs Q2 2026
00:00 / 00:00

Transcript Sections

Skip to Participants
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
Malavika William
VP of Global Head of Corporate Communications and Marketing at Establishment Labs

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
Malavika William
VP of Global Head of Corporate Communications and Marketing at Establishment Labs

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 6th, 2026.

Malavika William
Malavika William
VP of Global Head of Corporate Communications and Marketing at Establishment Labs

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
Peter Caldini
CEO at Establishment Labs

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
Peter Caldini
CEO at Establishment Labs

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
Peter Caldini
CEO at Establishment Labs

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
Peter Caldini
CEO at Establishment Labs

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
Peter Caldini
CEO at Establishment Labs

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
Peter Caldini
CEO at Establishment Labs

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
Peter Caldini
CEO at Establishment Labs

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
Peter Caldini
CEO at Establishment Labs

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
Peter Caldini
CEO at Establishment Labs

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
Peter Caldini
CEO at Establishment Labs

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
Peter Caldini
CEO at Establishment Labs

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
Peter Caldini
CEO at Establishment Labs

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
Peter Caldini
CEO at Establishment Labs

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
Peter Caldini
CEO at Establishment Labs

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
Peter Caldini
CEO at Establishment Labs

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
Sandra Harris
CFO at Establishment Labs

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
Sandra Harris
CFO at Establishment Labs

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 for $52 million for the quarter including [inaudible] 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
Sandra Harris
CFO at Establishment Labs

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
Sandra Harris
CFO at Establishment Labs

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
Peter Caldini
CEO at Establishment Labs

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
Josh Jennings
Analyst at TD Cowen

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
Peter Caldini
CEO at Establishment Labs

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
Peter Caldini
CEO at Establishment Labs

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
Josh Jennings
Analyst at TD Cowen

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
Peter Caldini
CEO at Establishment Labs

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
Peter Caldini
CEO at Establishment Labs

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
Sam Eiber
Analyst at U.S. Bancorp

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
Peter Caldini
CEO at Establishment Labs

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
Peter Caldini
CEO at Establishment Labs

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
Sam Eiber
Analyst at U.S. Bancorp

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
Sandra Harris
CFO at Establishment Labs

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
Sam Eiber
Analyst at U.S. Bancorp

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
Mason Carrico
Analyst at Stephens

Hey, guys. Thanks for-

Peter Caldini
Peter Caldini
CEO at Establishment Labs

Sure

Mason Carrico
Mason Carrico
Analyst at Stephens

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
Peter Caldini
CEO at Establishment Labs

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
Sandra Harris
CFO at Establishment Labs

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 Roberts from Canaccord Genuity. Please go ahead.

Caitlin Roberts
Caitlin Roberts
Analyst at Canaccord Genuity

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
Peter Caldini
CEO at Establishment Labs

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
Peter Caldini
CEO at Establishment Labs

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
Jane-Marie Lai
Analyst at Citi

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
Peter Caldini
CEO at Establishment Labs

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
Sandra Harris
CFO at Establishment Labs

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 million-$271 million. 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
Anthony Petrone
Analyst at Mizuho Financial Group

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
Peter Caldini
CEO at Establishment Labs

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
Peter Caldini
CEO at Establishment Labs

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
Mike Matson
Analyst at Needham & Company

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
Peter Caldini
CEO at Establishment Labs

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
Peter Caldini
CEO at Establishment Labs

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
Sandra Harris
CFO at Establishment Labs

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 JPMorgan. Please go ahead.

Allen Gong
Allen Gong
Analyst at JPMorgan

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
Sandra Harris
CFO at Establishment Labs

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
Matthew Taylor
Analyst at Jefferies

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
Sandra Harris
CFO at Establishment Labs

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
Peter Caldini
CEO at Establishment Labs

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.

Executives
    • Malavika William
      Malavika William
      VP of Global Head of Corporate Communications and Marketing
    • Peter Caldini
      Peter Caldini
      CEO
    • Sandra Harris
      Sandra Harris
      CFO
Analysts
Powered by Quartr