Good afternoon. I'm Josh Chang from the TD Cowen Medical Devices team, and we are moving deeper and deeper down the medical devices track on day two of the 45th Annual TD Cowen Health Care Conference. It's, with great joy that we were introduced to this management team. Not pun intended, or not pun, but just, actually, I guess there was a reference to your joy program. But we'd love to introduce the executives from Establishment Labs. We have Juan José Chacón Quirós, founder and CEO, and Chief Financial Officer, Raj Denhoy. Gentlemen, thanks for coming to Boston, and great to, great to see you live.
Thank you, Josh.
Thanks, Josh.
Some mixed emotions here. I think this may be our last fireside chat, Juan Jos é . It's, we're sad to see you depart the CEO seat. It's been quite a run, but I, my understanding is that the run won't end in terms of your involvement with the company. I know you've reviewed this multiple times over the last two months, but maybe just for my personal benefit, explain like what your role will transform to from, as you leave the CEO seat.
Yeah, absolutely. I think you might see me again because, you know, as founder of this company and, you know, at a personal level, most likely still the largest shareholder. I care very much about this company. I started this in my parents' house 20 years ago, grew it to where it is today. You know, I'm going to be doing not only what I love doing, but what I'm best at, which is really focusing on the innovation, making sure that we go from ideation through the entire process to see this in the market in a way that it benefits women's health, that it grows the market of breast aesthetics and solves many of the problems in breast reconstruction.
The other piece is the advocacy piece, you know, talking to plastic surgeons and making sure that they understand why the adoption of this technology is not only going to improve the outcomes for their patients, but also increase their markets. In a sense, I think, you know, extremely happy to see Pete taking the role of CEO. I think, you know, the work that he has already done since he joined us in November of 2023 showcases his capabilities and skills. In the evolution of this company, what we need now is the operational excellence to bring us to profitability. I am going to be supporting him and working with him. I will continue as a board member.
You know, the board decided to do a market check, and I think we're in that process, but I'll be very happy once Pete is confirmed.
Appreciate that. It's great to hear that you'll still be deeply involved with the company, which I think I understood prior to this discussion, but good to reiterate. You know, I think I, over the years, I've, I believe that you had, you had one of the best counter consensus calls in the medical device industry for the last 10+ years, just in terms of your conviction that SmoothSilk surface was a better solution and a safer option for women who were looking to have breast implants, whether it was augmentation or reconstruction. You moved on from there with even more innovation with ergonomics and building out the whole portfolio.
It's come, you know, you kind of, you crossed the finish line late last year when your team drove Motiva through the U.S. regulatory tape and achieved FDA approval. One of the things that struck me early this year in San Francisco when you guys hosted an analyst event was, and reported on the U.S. launch metrics, just how much momentum you had secured in the very early days. Maybe you could just, you know, review some of the parameters of the strong U.S. launch and what's driven the $35 million revenue guidance for 2025.
Yeah, I think when you look at, you know, the launch, I mean, just think about it. We got approved on September 26 of last year, and we were ready in market a couple of weeks later. You know, we were able to secure a first number of accounts. Many of them were our investigators in the U.S. clinical trial and some of the surgeons who travel abroad often and had already seen from their peers the potential benefits of Motiva implants in their practice. You know, the metrics are just through the roof. You know, when you think about, you know, we continue to onboard an average five accounts per day. We've opened basically 650 accounts. As of last Friday, 450 of those had already ordered, 88% reordered.
Some of the reasoning behind it is also as important, you know, we have never seen the mix between SmoothSilk Round and Ergonomic trend so much to Ergonomic so fast. We're sitting at around 60%. That's big news because that implant comes at a premium to our competitors. That premium is based on patient choice, which means women are asking for it. It means surgeons are starting to understand the benefits. All of that kind of showcases, you know, the things that we are seeing in the market, which is, you know, plastic surgeons are super excited about the technology after, you know, more than 25 years of not having any innovation in the market.
Thank you. The Motiva launch has definitely created significant buzz in the U.S. plastic surgeon community. I think they've, well, many have been very active on social media. Many have been vocal in publications, in New York and other major cities. Maybe you could just talk about, in terms of those accounts that you've opened up, are most of them single plastic surgeon accounts or are they multi-plastic surgeon accounts? My assumption is that there's more than one in most of these accounts. Maybe those metrics of 450 active orders is minimizing just in terms of number of surgeons that are actually engaged in adopting Motiva.
Many of these clinics have more than one plastic surgeon. In some cases, perhaps our biggest account today is a group of 13 clinics, and that includes more than 20 plastic surgeons. Of course, you know, that's the type of mix that we'd like to see early on is that a lot of these accounts are some of the best accounts in the United States. As we move forward, of course, we'll continue gaining share from all of the active competitors. Probably the other, you know, really interesting aspect that we are seeing is, you know, how organic the communication is about Motiva implants from these clinics, meaning they're using our technology to showcase, you know, their clinic.
They're talking about Motiva, about the benefits, you know, the potential option of putting the implant above the muscle without having increased capsular contracture or, you know, rippling of an implant. I think the recovery rates, like, you know, softer recovery, something that they are definitely communicating on. This is happening organically. You know, they're of course using the benefits of the, of the devices, but, you know, when you think about more than $1.8 billion impressions in social media, that's what's driving the other key point of the launch, which is women asking, you know, for Motiva by name because that not only, you know, confirms the choice of the surgeon, it is powering it up because the more women talk about Motiva, the more other women in, you know, in the word of mouth, mechanism will be taking place.
These women that are receiving Motiva behave like super consumers, meaning they're willing to tell their friends about their choice.
You answered one of my next questions, just that the patient demand is surging. We've anecdotally heard plastic surgeons relay that they're converting almost 100% of the patients in their queue over to Motiva or through primarily patient demand. Maybe build on that, and outside of surgeons kind of putting forward their experience with Motiva and support of Motiva, I think there's some influencers, and you also announced that there was a celebrity in the United States that was gonna become a, I think, spokesperson. Maybe help talk about the social media, maybe expand on your comments about the social media impact to patient demand and this celebrity spokesperson.
Yeah, I think one of the important things is we wanted to have more than 500 accounts before we would do any type of effort like this partnership with a celebrity that is, you know, super high in the popularity index and also very well known by most Americans. That makes it a wonderful partnership because also the authenticity of her voice and, you know, the journey that she undertook is fundamental for this, powering other women who had been considering to say, you know, with this technology, I can make the same choice. With the number of accounts sitting at 650, this is an investment that will yield a big ROI for us and will power even more the excitement.
You know, what we're looking for is, of course, getting more inbounds into the clinics, but also having the surgeons, you know, use more often in their choice of implants Motiva than others.
Excellent. I wanted to, Raj, ask you just about the gross margin benefit of the U.S. launch over time. We’ve talked about this before, but just, with Juan Jos é ’s comments and you sharing on the fourth quarter call about the mix of ergonomics vs round and so far in the U.S. launch, and that could even expand even further, which would, my assumption, drive even a better gross margin expansion, contribution from the U.S. franchise. Maybe walk us through how we should be thinking about the profitability of the U.S. business or gross margin and profitability. Thanks.
Yeah, it's significant. You know, when one looks at the, the average realized price for us outside the United States currently, and keeping in mind that right now the majority of our sales outside the United States are through distributors, right? So we realize half the, typically half the end market economics. When one compares our current ASP on a blended basis outside the United States to what it is in the United States, it's more than 2x in the United States. The cost of making the implant is essentially the same. The gross margin, you know, benefit as the U.S. scales over the next several quarters and years is gonna be very significant.
I have had the pleasure of venturing down to Costa Rica to see the new manufacturing facility and headquarters. You guys have capacity to, I think, supply 50% of the annual global breast implant volumes. Just bringing up Costa Rica and all the headlines over the past 24+ hours or past number of weeks just on tariffs, maybe help us understand how Establishment is positioned in the setting of the U.S. implementing tariffs on Canada, Mexico, and taking up tariffs on China.
I think it's important to realize the framework at which this is taking place. And when you think about, like, all of our implants are manufactured in Costa Rica and, you know, basically the IP is located in Costa Rica. So the country of origin is there. Costa Rica is free trade, with the U.S., doesn't have any tariffs on U.S. products, and it's a big ally of the United States. There's no migration problem with Costa Rica or any other, you know, issue that could, you know, make it a reason for a retaliatory tariff. I think, you know, when you think about the framework, that is coming, which is, you know, a set of other tariffs, they're not, you know, directly related to our industry. Even after that, you will say, well, why would they single out Costa Rica before so many others?
Beyond that, I think, you know, the Costa Rican origin allows you to also enter without tariffs into China with a free trade agreement, most countries in the Americas, all of Europe. It is actually a great place to be with all of this geopolitical uncertainty.
You guys are well positioned. I wanted to build on the U.S. business and I do not think this has gotten lost, but the U.S. Motiva launch in play, that has gained a lot of attention, but you guys also have the recon indication that is brewing and may maybe get a FDA approval in the relative near term. Maybe take us through, you have Flora already launched. Maybe just talk, take us through how Flora has kind of set a foundation and some hostile accounts for this U.S. recon effort, and when you could start to see contributions.
The first thing to say is that Flora is, you know, first and only commercially available tissue expander that allows for MRIs, CTE, during the expansion process of the, the reconstruction. And that is such a huge difference for women undertaking these procedures. Just a couple of weeks ago, MD Anderson, an interdisciplinary group there, published this paper in which they talked very clearly about how this is changing the complete journey of, you know, the patient leading to better clinical outcomes. You know, it's the fact that you can pinpoint the radiation dosimetry levels to the right place. It's also that, you know, the amount of time that they have to spend making the calculations for radiation oncology, all of that is being reduced, and that is positive for that team.
You know, right now we're focused, you know, on this launch into aesthetics, but, you know, this summer we're going to achieve the three-year mark in our, you know, breast reconstruction cohorts. This will allow us to potentially provide, you know, the supplement to the FDA this fall and think about, you know, nine months, you know, in, in average to be able to get that supplement approved. The other part of that is that, you know, once you have the tissue expander and the implant, you can start, you know, putting together the benefits of our SmoothSilk surface because that will allow many hospitals to do things in a very different way. Also, how often they use ADMs, how often they use meshes that can provide savings for those institutions. I think as, as we get closer to that, that's gonna be pretty exciting.
You know, the market for breast reconstruction is very, very attractive because you're recognizing, you know, revenue per implant at almost double than in the aesthetic market. You know, the tissue expanders also, I mean, we're recognizing already about triple than what we recognize in Europe. That has huge effects in the gross margin differentials that we're gonna see in the future. Of course, you know, for all of this year, we have so much to grow into with aesthetics, but next year is going to be pretty exciting with the launch into breast reconstruction.
I think you, you've had a vision on driving augmentation aesthetic outcomes in reconstruction procedures. And I think you guys have been successful in that initiative internationally, but maybe just talk about that effort and what you're seeing on the aesthetic outcome side as well as, you know, maintaining the safety profile in recon.
No, absolutely. I think, you know, this aesthetic breast recon initiative that we've been, you know, working on for many years, it's getting, you know, closer and closer to something that can be applied in countries like the United States. You know, it is not only the things that you can do with our tissue expander that changes, you know, the standard for that softer, you know, breast augmentation, but also softer breast reconstruction now that we are seeing, you know, the clinical results. Beyond that, you know, we're starting to use our minimally invasive technologies in breast reconstruction to treat the contralateral size and de-escalate therapeutically the breast reconstruction, but also in terms of using single port, you know, mastectomies and also robotic mastectomies to then do a better breast reconstruction.
Actually, in June in Paris, we have the first ever, you know, minimally invasive breast, you know, summit, and that will include an entire day on robotic and single port using conjunction with Motiva implants. These are great developments. It shows you really where, you know, this aesthetic breast recon initiative is going for us.
That's exciting. The last question on, on, maybe not the last one, but another layer of growth for the U.S. in the out years is the introduction of the Mia FemTech or FemTech technology as minimally invasive offerings. You have Preserve now in the mix and Mia. Maybe talk about the strategy both on the regulatory front and the commercial front in terms of bringing those two, well, I guess they are part of the same platform, but two different offerings into the U.S..
Our minimally invasive platform is something we've been working on, you know, for over a decade, and now we're starting to see the benefits of all the work that our amazing R&D team has done with the clinical evidence that we've been able to gather as well. You know, as you see for the United States, you know, most likely, you know, we will have tools necessary for the Preserve less invasive breast procedures, you know, taking place throughout this year, which will allow us potentially for a launch of Preserve in the United States in 2026 with the ergonomics one line. Beyond that, we have the ergonomics two line, which is what allows for the injectable implant and full minimally invasive.
I think that's a couple of years out, but also super exciting to see that it's not only what, you know, the current approval has, you know, has meant to plastic surgeons in the United States, you know, the complete change in, in, in technology, but also what's coming ahead, you know, to less invasive procedures. With Preserve, you can do, you know, breast augmentations of more than two sizes up, with a very controlled environment, preserving the breast tissue for a stable result over time. You know, moving into full minimally invasive. It's a super cycle of innovation that will take place, and it's gonna be, you know, a big, big benefit to, to the surgeons and also to, expanding the market in the U.S..
Should investors be thinking that the supplemental PMA pathway is potentially open for those two products, Preservé and Mia, in the United States, or is that still TBD, and when will you be able to share the final ruling on the pathway that's open for Establishment?
Actually, very, very important because for Preservé, we can do Preservé with ergonomics one and some of the tools that we use already for Mia. This is what allows, you know, de-launch potentially for 2026 ahead of our expectations. Then, you know, I think a little bit of a, of a more of an unknown, you know, of exactly when we will have the ergonomics two line, which is what allows for Mia, you know, but it makes you think that, you know, even if that took a couple of years from now, you know, Preserve is going to be a phenomenal move into less invasive procedures and that will happen.
We'd love to transition over to Mia. In the international, you've got to build opportunity. You've built out the foundation. Seems like there's some inflection in terms of number of accounts that are being added and then just utilization rates at these accounts. I think you talked about maybe $8 million-$10 million in Mia revenue in 2025. Maybe just relay the drivers of the assumptions baked into that. And then two, you know, how big can Mia be internationally?
Yeah, I think it's, you know, the idea this year is to more than double the number of clinics, more than double the number of procedures, organic procedures taking place in the countries where we have launched at, you know, more and more cities, of course, in the countries where we have launched. You know, if you think to understand Mia and what a big shift it is for the clinics that have launched is, you know, take a, you know, clinics in Europe last year. You know, if you take the assumption that in most European markets, revenue was flat for breast and in some countries down, in the Mia clinics, revenue for breast grew 50-80% based on Mia. Why? Because it's attracting a new group of customers.
You know, we've given some of those numbers, you know, more than 40% women were not considering at all a breast augmentation. That's what we wanna hear. This industry has been, you know, pretty much stagnant for, you know, the last 10 years. This is going to provide a wave of growth. Our calculations is that, you know, the market of women who are using padded bras, push-up bras, who become acquainted with Mia and would eventually, you know, at full awareness level, be willing to do it is 11x the current market for breast aesthetics. We've seen this before, you know, before fillers and toxins and, you know, energy devices for the face and, you know, the facelift, the change has been a 100 X in the last 20 years.
You know, we've seen it before in aesthetics. I think, you know, you just have to be patient of how that builds. The first couple of years are the most difficult for a new category. Just have to be patient, but already putting out there $8 million-$10 million gives you an understanding of where it could go after that.
Understood. Maybe to stick with the minimally invasive portfolio, you guys have a development program for gluteal enhancement. Any updates there, and how should we think about timing of any international launch?
Gluteal ergonomic modeling addresses, I would say, almost like an orphan indication in aesthetics. There's, you know, about 800,000 procedures a year and most of them being done with BBLs, elastomeric implants, fillers. The complication rate is through the roof. There's even a mortality rate. As a women's health company, it's something we wanted to solve. Gluteal ergonomic modeling basically allows for this procedure to take place in about 20 minutes without general anesthesia. Recovery time is completely different. Safety. We finished our feasibility study, you know, now finishing the enrollment of our pivotal study. With that, we will seek approval first, most likely in Latin America, and then we'll move to the other areas of the world. We haven't put out an exact date, but, you know, we're working on this.
I think we will update later this year on what a go-to-market could be.
Ultimately you will bring that into the United States is our understanding. Just, I mean, timelines and the regulatory pathway or TBDs is how we can...
For now, this is something that we are, you know, we're already working on, but I think further along in this year, we'll have more information on this.
Okay. In 2025, your revenue guidance, you guys have relayed that you're assuming mid-single digit growth for the core international business, which includes Mia. I just wanted to get a better sense of assumptions. I think you were clear on China just in terms of the first half, all the inventory stocking from last year will work through and you'll start to see a return of revenue contributions in the second half. I really wanted to talk about Central and Southern America and Brazil and how those markets are trending. Any stabilization and anything that's baked in the guidance in terms of improvement or is it really stability in 2025?
Yeah, I think it's really, as you described that, you know, we saw in really starting in the middle part of 2023 that the markets, you know, a lot of places around the world really softened fairly dramatically. That continued into 2024. As we're exiting 2024, a lot of the markets feel more stable. Certainly Latin America, we feel in the latter part of last year, we've sort of touched some sort of bottom and it seems to be a bit more stable. We're not assuming any sort of growth or recovery next year, but the market feels a bit more stable at the current level. I offer similar, you know, views in Europe and really APAC outside of, as you described, China, the phenomenon there we're describing for next year, but the markets overall feel relatively stable.
When we think about the guidance we provided for next year, we're not assuming anything heroic in terms of market acceleration or any sort of underlying improvement. For us to achieve mid-single digit growth, you know, with Mia, with Preserve, with all the things we're bringing to market along with just the benefits of our technology, we feel very comfortable with that outlook.
Yeah. I think in addition to that, there's a halo effect that we're starting to see OUS on the FDA approval. Remember, there's, you know, many, many clinics OUS that, you know, use the slogan only FDA approved products. Before that approval, J&J was the only other one that was approved in Q4. Just to give you a metric, in our direct markets, we gained over 100 accounts that, you know, came from that group.
That is also going to provide a new, a new source of market share gains.
Thanks for sharing that. Maybe just to touch on the competitive landscape and how it's evolving or not evolving. You know, it doesn't seem as if the major, the larger competitors have really had a response to Motiva in international markets. Anything on your radar, in terms of the strategy from Johnson & Johnson or AbbVie/ Allergan in the United States? If you guys are launching Motiva, what is just counter marketing or anything, anything in their pipeline that you're concerned about?
You know, of course they're defending this market. I think the other thing to understand is that these companies are distracted. We're not focusing on this, and we are absolutely focusing on this because we're focused on the end consumer. We're focused on women's health, and we're focused on one really important thing to plastic surgeons, bringing up plastic surgery thanks to this technology. If you think about the products that those companies sell, they're not exclusive to plastic surgeons. Our ability to do that is giving a lot of surgeons the opening to say, you know what, I don't care if I got all these perks from this company, I'd rather stick with what's best for my patients. This will have, you know, a positive effect for the number of women who will access breast augmentation.
I think that's one of the other big things from this launch is that, you know, the use of a bundle against that has been, you know, of no detriment to our efforts. It was perhaps one of our biggest risk factors these days. I would say, you know, it's becoming clear that technology is changing what used to be a commodity market.
Maybe the last question, for you guys and, you know, when going back to the, the visit down to the new manufacturing facility slash new headquarters, super impressive to see how, as it set up a training center there and, I mean, I was imagining at that time and I'm, I'm betting now that as you bring surgeons down to, to go through some of those training exercises and, it's such an impressive effort and structure, was hoping you could share something, anything about the conversion rates of, of surgeons, coming down to Costa Rica, getting trained, seeing the technology, seeing all of your capabilities and, and the infrastructure and, and, and how that translates into surgeon adoption.
Yeah, we're having an average about 15-20 plastic surgeons per month from the U.S. coming to our headquarters. We're also having delegations from other countries with key surgeons, academics, and people who matter, in that sense. You know, it's a complete experience change because they see the innovation in our manufacturing, the innovation in our R&D pipeline, the innovation in the techniques, because they witness in our global training center the new surgical techniques to simplify, you know, some of the situations that they might have experienced in the past and make for better outcomes. We're doing also a new type of modality in which we're doing live from the soleum to also broadcast to an online audience. We're getting even more ROI out of this.
It is really becoming a big factor for this next generation because we are not only giving the new technology, we are teaching techniques that will make the procedures better and simpler.
I think we'll stop there and just end with a, you know, congratulations on the long journey you've been on and getting the company to U.S. approval and the commercial era globally. It's fantastic. Thank you guys for spending time with us today.
Thank you, Josh. Thank you.