Caldini and CFO Raj Denhoy joining us here in Boston. Gentlemen, thank you guys for making the trek-
Thank you. Yep, thank you.
-north.
In the weather.
The weather's held up, though.
Yeah.
I know you guys are intermittently or a lot of the time in Costa Rica, which is much nicer, but weather is holding a little bit on a relative basis from past years. Well, you, your team has executed and had an outstanding 2025 and the outlook for 2026 is very strong. I know a lot of the focus from the investor on the Motiva launch and that's been stellar. I think maybe to start, you know, maybe some of the drivers of the outperformance relative to your initial guidance in 2025 and any assumptions you're willing to share just in terms of the guidance that you've issued for 2026 for that franchise, and maybe we'll have a couple follow-ups.
I mean, one of the data points we picked up over the last couple months is, it's possible that, your team, your commercial team hasn't gone a day without adding a new account. There's some record that's continuing, and I don't think that record's been broken, though. just one data point that we've had, but maybe you can build on that.
Yeah, I mean, I think 2025 as you mentioned, I think it was a very successful year for us in terms of, you know, what we were able to accomplish in the U.S. You know, we've said this a number of times, I mean, it exceeded all our expectations. Obviously, prior to launch, we were very confident about the opportunity. I mean, bringing in what we believe to be the best implants in the industry in a, in a, in a market that hasn't seen innovation in decades. You know, we assembled a best-in-class organization and, you know, I think that we were very pleased with the success. I mean, but it was beyond what we had expected. You know, I think we opened up 1,500 accounts. That was beyond what we had originally planned.
You know, I think very strong growth, you know, a lot of it with not only the penetration, but also getting the utilization, a lot of the marketing activities, you know, where patients are walking in, specifically asking for Motiva. I think that's very rare, you know, certainly in this category. Those were key drivers for our success, and I think as you go into 2026, you know, we've had very strong momentum in this year, and we expect not only to continue to add accounts, but increase the share in those accounts. We are bringing in, you know, we've mentioned before, up to 15 reps, which is gonna continue to drive growth for us.
We have the Preservé launch, which has been very successful outside the U.S., and we had some early experience that was very positive. That will continue to be key drivers for us in 2026. You know, when you start looking at 2027, you're gonna see the impact of the reconstruction indication, also expanding the innovation pipeline.
Outstanding. Maybe just stick on 2025 for a minute and just outperforming that initial guidance range. You know, we had heard over the years prior to the U.S. launch about this phenomenon in other countries about patients coming in and asking for Motiva specifically. I think Establishment Labs had this social media or direct-to-consumer marketing playbook down, and you're executing in the U.S. as well. Maybe help us just any details you can share just on that [DTC] campaign. I know you have some influencers. You have some celebrities with the Meghan Trainor partnership. Maybe talk to us about the success helping you outpace initial projections in 2025-
Sure
...and then how that, effort evolves in 2026 and beyond in the U.S.
Yeah. I think, as you mentioned, we had a number of key influencers. We also did the Meghan Trainor, which I think is very unique to the category, that created a lot of demand. It's also, you know, I think with the U.S. market, there was just not a lot of new news, and I think a lot of built-up demand. You know, while we were kind of feeding the marketplace, we were also you saw a lot of this coming from the surgeons themselves. I mean, they were really looking for new news. I think they were very excited about the launch of Motiva, and I think they'll help drive a lot of that awareness. As we go into to 2026, I mean, we still have the same playbook.
We're gonna continue to invest in that as much as Raj lets us invest in it. I think that will continue to be a key driver for our success.
Was there anything on just the pricing dynamics? You described a pricing strategy of initially bringing in Motiva, and on par with the premium implant pricing at different potential customers and current customers, their top-tier implant, and then, you know, moving up the line from Motiva to Motiva Round and then Ergonomix. Anything that surprised you just in terms of the receptivity or did it all kind of play out relative to expectations in terms of implant pricing?
I would say in general, I think it played out the way we expected. You know, I think if you're providing a premium implant from a safety standpoint as well as from a performance standpoint, you would expect to be able to receive a premium. We haven't seen any impact and from a pricing standpoint, so I think that's been very positive for us. I think when you start getting into the innovation and the Preservé, I think there's a lot more pricing flexibility. I mean, I think when we first launched Motiva in the U.S., there was reference points, right? There was existing products out there, so we pegged at a premium.
When you start getting out to truly new innovation, there are no reference points, and I think it gives us a lot more flexibility in terms of our pricing, and we're gonna be realizing this in 2026.
Excellent. Just thinking about the international experience prior to the U.S. launch, I mean, it's our understanding. I don't have any makeshift data that I can share, but that there was this move towards higher percentage of Ergonomix implants, the premium price implants, being adopted and patients demanding them or choosing them even at the premium price. That's playing out in the United States is my understanding. Anything you can share just in terms of how that played out in 2025, and do you expect the Ergonomix percentage of total to get even higher in... Sorry, how'd that play out in 2025, and does that get better in 2026 and beyond?
Well, I think importantly, you know, if you think about the product families, Round, Ergonomix, Ergonomix2, a lot of the reasons people pick Round versus Ergonomix is really an aesthetic choice. There's no sacrifice you're making from a product performance standpoint in picking Round versus Ergonomix. We've seen in the United States, it's kind of settled out roughly 55%-60% is Ergonomix. The balance being Round. That's been relatively stable now for a period of time. I think as Peter described, you know, if you think about our pipeline in the United States, we have Round and Ergonomix, right? Next year, we're gonna have Preservé. Beyond that, you'll have Ergonomix2, you'll have Mia.
There's a lot of things coming, that are at the upper end of that continuum of what we can charge in terms of price. As Peter noted, there's a lot of innovation that comes with those products which really justify us, charging more for those.
Great. You know, there are many merits and value propositions of the Motiva platform relative to the incumbent implants prior to the U.S. Motiva launch. I mean, smaller scar, better aesthetic outcome ability to place in front of the muscle behind the pectoralis. Have you seen or is it your sense that patients in front of minimally invasive offerings coming on board that there's patients coming off the sidelines just with, not just, but with the Motiva and Ergonomix launches in the United States, or is that something that's still on tap?
I mean, I think with listen, some of the research we've done in the U.S., we're finding that the surgeons that are predominantly Motiva generally are having, you know, stronger sales versus the ones that are not. I think, you know, some of that, you know, some of the marketing activities, I think some of the demand that we've been able to create, I think, is driving, you know, more patients. We've learned through our Preservé early experience that about 14%, of women that got the procedure were not considering breast augmentation. This is a small sample size, but that's a good indication. Communicated that, you know, close to 60% are willing to pay a premium for these type of procedures.
I think a lot of the activities that we're doing also when you're driving the innovation is bringing a number of women, you know, that you said are on the sidelines and really considering breast augmentation, maybe for the first time or if they've had reservations about it.
I mean, just forecasting out just market growth, considering some of the price mix, patients coming off the sidelines. I mean, this breast implant market just on the augmentations bucket, I mean, we could see some stronger growth...
Yeah
as we move into this year through 2027, all the way to the end of the decade is our assumption. Is that the same assumption? I think you guys have painted that picture effectively, but just to recap.
Yeah, I think, I think that's what we expect, and I think for a number of reasons. One, there's just much more openness, you know, what we call the era of transparency, where women are talking more openly about, you know, getting these procedures. I think it's also some of the technology that we're bringing to market where it's no general anesthesia. I think that's a big barrier for a lot of women. smaller scars. I think there's a number of things that it's driving that we believe has the potential to increase the market size. Some of the early indication from, you know, some of the market research would give us that view as well. We'll see how that plays out during the course of the year.
You've kind of called out a number of tailwinds in play for the U.S. Motiva launch coming into 2026. You issued guidance of, you know, at least 30% revenue growth. I think just backing into where the consensus estimates sat prior to your fourth quarter earnings call in the low $80 million, that suggests it's probably a touch higher. Is that the right way to think about that initial guidance? I guess to add to this question, you know, you've had a conservative guidance playbook that you've been running since the launch. It's only been a short time. Let me just talk about the philosophy behind this guidance for U.S. revenues in 2026. I'll leave it there.
I think the math you described, you know, we gave overall guidance and midpoint being $265 million. We said the U.S. would exceed 30% of that. We gave ourselves some room there. You know, you talked about numbers in the, you know, low 80s, mid-80s, for the U.S. That's reasonable. You know, you just do the math, that kind of suggests that. You know, and you're right, we have tried to be conservative. You know, we're learning as we go in the U.S., right? We're in the second year here. We have a lot of momentum, a lot of tailwinds. We hope to do better.
Raj, I'd love to just ask you about your transition out of the CFO seat and into your new position, within Establishment Labs. It sounds like it's strategic. I mean, you're deep within the company and, it can help on some of these, strategy initiatives and business development. Maybe just talk about that move, how you're feeling about it, and, it sounds pretty exciting.
Yeah. I mean, as I think your question sort of get at, the company is in a really good spot. You know, we're performing very well. It's been a.
You know, the last few years it's been a little rocky, you know, if you go back to 2023, but the last couple of years, particularly with the U.S. launch, we're in a really good spot, you know, the business is performing well. When Peter and I talk about what is going to drive value creation for us going forward, certainly continued execution is a big part of that. There are these big other strategic questions around, you know, the innovation portfolio, what should we be emphasizing there? We're in 100 countries globally. You know, what should be the go-to-market strategy for us in a lot of areas? Business development, we haven't done a lot on. You know, we're a relatively small company despite, you know, the growth and everything we've been putting up.
Having the ability to focus on these things, I think is very important. I think the next few years we're gonna see a lot of opportunities for us as a company.
Yeah, I mean, just to add to that, I mean, I think the last 18 months we've been very focused on getting, you know, to profitability to improve our cash position, also executing on the U.S. and there was a lot of tough decisions during that process in terms of the right size of the organization, reallocating resources. We were very focused on the short-term execution, quite honestly, as we had a lot of opportunities, and Raj played a critical part of that. If you look at, if we really look into the future, if we really want to capitalize on all the innovation, all the things that we have, we need to have resources that can help drive that through the organization.
You know, Raj mentioned in terms of the innovation, we need to prioritize what innovation and what markets and when we're doing it, and then making sure you have the right go-to-market models. It's not just layering more innovation on top. We have to also look at our portfolio. You know, we have to manage our working capital, so you have to rightsize the portfolio. As Raj highlighted, we also don't really have BD resources. There's a lot of third-party opportunities out there that we can leverage companies. We're getting approached, you know, constantly about partnerships, but we don't have internal resources to do that. It's very important you have somebody in the leadership team that can really drive that. Raj knows the organization very well. He knows the industry very well.
He's had a lot of success, and I think he's the right person to really drive those initiatives through the organization.
Outstanding.
He also has the best job in the company now.
That's right. That's right. It is exciting times for Raj. Let's talk about some of the drivers of 2026 U.S. Motiva franchise success outside of just in the augmentation segment. Preservé we touched on a little bit, but I mean, I think you guys have laid out just the surgeon training kind of track for 2026. I mean, if there's opportunity, do you think you could accelerate that and then train more surgeons this year if the demand starts to get even more intense? How should we be thinking about that dynamic?
Yeah, I think in the U.S., I mean, that's a big part of our plan for Preservé. There's kind of four ways that we can train surgeons. The first one is the visits to Sulàyöm. You know, I think that's a very impactful way to get, you know, surgeons trained. It really gets them excited. They really understand how, you know, everything about Establishment Labs, the history, the DNA of the company, and that's probably the most impactful. Now, realistically, I think there's limited resources to do that. Now we have, especially with our early experienced surgeons, we're train the trainer. We're training those surgeons to train additional surgeons. They either come visit them and do the procedure themselves with that trainer, or they actually observe it. We also have cadaver labs.
It's something that as we the market, as we go through the year, we're gonna continue to evaluate that, and if there's opportunities to expand or a necessity to expand it, we're gonna be doing that.
It sounds like from your public comments and some discussions that the early experience in the limited launch last year, that there's, you know, just in terms of the premium price, not real pushback.
No.
It seems to be the initial surgeons are having a smooth experience in terms of seeing the demand and having the premium price for the surgery, absorbed or just digested by patients.
I think, you know, what we're seeing is at least 30%-50% increases for those surgeons. You know, I think anytime you launch a new product, that's always the most challenging question you're gonna get from the surgeon. You always expect a lot of pushback. In this one, I think there was absolutely no pushback. I think they were very positive as they see a true innovation in the marketplace, and there's no reference points that I mentioned before. I think that the pricing that we have, you know, I think, certainly is gonna be accepted in the marketplace. We're seeing that already, and I think that's gonna be a key driver for us.
Great. We got a question from the audience.
Picking up on this theme of pricing, you're charging a premium price because you've got a premium product. Are the plastic surgeons who are marketers and entrepreneurs, what percentage of them are in turn charging a premium for this procedure, Raj? Is it the majority?
Oh, I would say close to all of them. Do you wanna repeat the question?
Oh, yeah. I'll repeat the question. The question was just on premium pricing strategy for next generation Ergonomix and then minimally invasive products coming forward. It sounds like surgeons are digesting it, but are they passing the price on to their patients?
Yeah. I mean.
is that effective?
Yeah. What I mentioned before, and we've mentioned on the earnings call, on average, it's 30%-50% higher for that specific procedure. They are passing that along. They see that as a significant value, and the patients are, you know, for the most part are okay with it.
I've heard of some instances, correct me if I'm wrong, that some surgeons in specific regions where there's more flexibility from the patient population, but they're actually charging more than the premium you're charging and actually getting a higher margin surgery.
I think-
Is that playing out?
I think in general, surgeons are charging more than the premium, I think pretty much across the board. They're making increased profit selling our products.
Excellent. I'd love to hone in on before going over to reconstruction, but just thinking about the U.S. Motiva share outlook. You guys exited the exit run rate or share position was 20%-ish. That's a great initial year. Getting to 20% any market in the device world is a tremendous outcome. I mean, where do you, where do you see ultimately share being capped out at? Maybe challenging to answer, but I mean, our assumption in our team for the past couple of years is that, you know, 50% + is not improbable, but is that?
Yeah, I think that's.
Would you temper those assumptions?
No, I think that's very realistic. I mean, I think we expect to have a dominant share in the market over 50%. In the future, I think the question is at what timing. I think, you know, we've had a lot of success in driving share in 2025. We expect that to continue in 2026. Also at the same time, you know, we believe we have the potential to expand the market as well, right? While we're driving share, we're also expanding the marketplace. You know, we fully expect to have a dominant share, over 50% share in the U.S. like we do in all the OUS markets.
Excellent. wanted to move on to reconstruction. you guys have done a, I think, fantastic job setting the stage at the Investor Day. On these last couple earnings calls, just about the opportunity there, you have a presence already in 200+ hospitals with Flora, the tissue expander. I think you've talked about just the trajectory potentially matching, you know, the U.S. Motiva launch in the augmentation segment. maybe build on that. Just correct me if I'm wrong, but I think you guys have said that in the public domain, and just how you're feeling about the reconstruction launch ultimately and the buzz that's already out there in the plastic surgery community.
Yeah. I think, obviously entering the reconstruction, from a revenue standpoint, it's the same size, so we're really, you know, doubling the TAM, for us. You know, I think we expect to have the same type of success in reconstruction that we've had in the augmentation space. We've already, you know, as you mentioned, we've already kind of got a little bit of a beachhead in over 200 accounts, so we expect that, you know, that will accelerate, make it a little bit quicker for us. We're very excited about that opportunity. We're just waiting for the FDA to give us the thumbs up.
Excellent. Maybe there's the talk about the catalyst upcoming for this on the way to FDA approval for the reconstruction franchise. Are there anything to highlight just from the data that's accrued? You know, think about the FDA trial for PMA trial for Motiva in primary augmentation revision. You know, the capsular contracture rate, the rupture rates were revolutionary. Anything to highlight on the reconstruction data? Any, any, I guess, just milestones in front of FDA approval that we should have on our radar?
Yeah. The reconstruction data has not been publicly shared. I think our view is that we'd like to share it as we get closer to the commercial launch to take the most advantage of it, as opposed to now when essentially we can't talk about it as a company, right? Because it's not approved. Again, there's no reason to think that that data won't be as good as it is in augmentation. It's a more challenging patient population, obviously, but the implant is still the same. As Peter noted, you know, it's been submitted. The FDA is reviewing it. The approval path should be a little bit easier. It should be easier than the augmentation. It's part of the same PMA.
The FDA needs to review that data set, but they don't have to go back and do things like the manufacturing audit and other parts of it. It's really just reviewing that data set. Again, it's in the hands of the FDA. It's difficult to know when, but we're expecting it soon.
I think you guys highlighted this at the Investor Day, your Founder and former CEO, Juan José, has talked about the mission to deliver outcomes, aesthetic outcomes that are on par, in recon surgeries that are on par with aesthetic or augmentation surgeries. Can you just talk about where that stands with the international experience and in the clinical trial? Has that been attained already, or is that something that's gonna help drive adoption and penetration and maybe even this phenomenon that you've seen in augmentation where patients are coming in, recon patients demanding Motiva ergonomics?
In international markets, you are seeing outcomes now. There are surgeons who are able to achieve the aesthetic outcomes in reconstruction that rival what they would do on a pure augmentation. A lot of that is technique and experience, but there are outcomes now that are similar to that. You know, the technologies we bring, not just the implants, but other things we have under development, will help in that regard. As you noted, it is a mission of the company to try to kind of democratize breast reconstruction to drive better outcomes, encourage more people to go down that path. We're excited. I mean, it's a big opportunity, as Peter noted. In the U.S., it more than doubles or essentially doubles the size of the opportunity for us.
It's an important market that we feel we have to do well in.
Excellent. One last question just on 2026 and on the augmentation market and just the introduction of the smaller size Motiva implants. Just timing of that and how do you see that playing out? I mean, You've already have accounts that are utilizing Motiva at a high clip. Does that just open up another 10% of cases at those centers, and does it help you-
I think that that's what we estimate. I mean, that's what we've kinda learned from our sales force. I mean, it's about 10% of the market that we're not currently playing in. You know, that obviously varies by account. We expect that to get approved the first half of this year. I think that will open up certainly the ability for us to expand our share in some of the accounts.
Great. Just with all the pricing discussions, I know you guys have reviewed this thoroughly, but just on the contribution to the margin expansion trajectory, gross margin expansion, you know, I think there's some opportunities to invest more heavily with the reconstruction launch, but thinking about EBITDA margin ultimately, maybe just help us high level review the drivers of margin expansion as we think about this year, 2027 and beyond.
Yeah, I mean, now, you think about what is driving our growth as an organization. You know, the United States, a bigger focus on doing well in direct markets internationally, the minimally invasive portfolio, ultimately reconstruction. You know, all of these drivers are higher gross margin than we have had historically, right? Where we have been 100% outside the United States and frankly, primarily in distribution markets. You're seeing a nice tailwind on our gross margin that should continue as those drivers become a bigger portion of the mix. As you work down the P&L, you think about the expenses, right? The operating expenses for us as a company. You know, we've been in business for 20 years now, right? There's been a lot of investment in establishing that commercial infrastructure, right?
The manufacturing footprint in Costa Rica, the commercial organization, regulatory, R&D, all of those aspects have largely been established. The incremental investments from here are going to be to continue to support that commercial launch, but those investments will be at a rate, you know, well below what the top line should grow. That's what has driven us to EBITDA positivity in 2025 and will push us to cash flow break even this year and continue to push us beyond that.
Only a couple minutes left here. I haven't touched on the international business. There seem to be a number of tailwinds in play, market stabilizing.
Right.
You've got minimally invasive launch or Mia gaining more traction. Got Preservé launch, China, initial stages of coming back on board, it sounds like. Maybe walk us through just the drivers of the international franchise and then with the guidance, I believe it's kind of single-digit growth, OUS and what are some of the assumptions there? What could drive upside?
I think in general, if you look at all the OUS markets, we're seeing relatively stable demand across, you know, most of the markets. There's really not that dynamic, and, you know, we're seeing healthy growth. What was very important for us going into 2025 is that we prioritize our direct markets. These are markets where we have much better economics, and doing so, we reallocated resource to the direct markets. We made some organizational change, and we're very pleased with the progress that we've seen there. By doing that, you also reduce your dependency on the distributors, which I think historically was probably too much.
We've made tremendous progress with that, and a lot of it's just focus of the organization, getting the right people, making sure you get the resources to those direct markets. You overlay the launch of the minimally invasive platform with Preservé. That's been a key driver for growth this past year. We're very pleased with the progress and just speaking around China, I think, you know, we felt I mean, there has been a contraction in the market, but what we weren't happy with is the development of our distributor and building their commercial capabilities. We put in a lot of work, a lot of time with that distributor. I've spent a lot of time personally, my career in China.
It's a tough market, and I think we're starting to see some progress there, especially from a sell-out standpoint. You know, we're pleased with the progress, and we expect China to be like every other market we have in Asia. You know, a certain point to be a dominant share as well.
Excellent. The minimally invasive or the target for 2026 for just the minimally invasive portfolio across the board, Mia and Preservé U.S., OUS, Mia OUS, is in that $30 million plus range. You know, if you just back of the envelope assumption that Mia did a little bit better than $10 million in 2025, maybe closer to $15 million or somewhere in between $10 million and $15 million, that leaves $15 million-$20 million for Preservé. Just looking at the overall guidance, it's less than 10%, maybe probably closer than 5%, maybe almost 2x pricing then on volumes, it's low single digit volumes for Preservé. It seems relatively conservative.
Yeah. I think there's an upside there.
Any just comment, comments on that back of the envelope math there?
It is conservative. Yes. The math was great, Josh. I mean, I think that like we see, you know, there's a, there is a potential upside there. You know, and, you know, we're very happy with the progress and, we've seen good success so far, and there's a lot of interest and, you know, I think you're highlighting, you know, one area that we see, potential upside.
Outstanding. Well, thank you guys so much for participating again this year. Thanks for the time here during this chat and have a great rest of the day. Good luck with your meetings.
Great. Yeah. Thank you. Thank you.