I'm Matt Taylor, the U.S. Medical Supplies and Devices Analyst here at Jefferies, and pleased to be joined by the management team from Establishment Labs. Our [right] is Peter Caldini, the CEO, and Raj Denhoy, the CFO. We'll have about 25 minutes here for a fireside chat with no fire. Maybe just to kick things off, a lot of these meetings, the general meetings here, there are some folks who are newer to the story. Sure. I always want to start with a couple of high-level questions. Maybe you could just give us a little bit of an overview of the company, the portfolio, how it was founded, and sort of your central thesis in terms of why you think you can be a market leader in the women's health and breast augmentation space. Yeah, so Establishment Labs is a global medtech company really dedicated to advancing women's health in breast aesthetics and reconstruction. We're in 90 countries around the world. We just entered the U.S. after FDA approval, so this is our first year. We have a lot of success so far in the U.S. We're very happy with our progress. I think what really differentiates ourselves and why we are a market leader around the world is we have the best implants in the industry. That's, you know, from a safety standpoint. It's also from a performance standpoint. You know, if you look at some of the technology, the proprietary SmoothSilk surface, it enhances biocompatibility. It also reduces inflammation. You end up having and you're seeing a much better safety profile, which we saw in a lot of the FDA studies. We have less than 1% device-related implications versus a competitive set that is far superior to what exists in the market. We have a very broad product portfolio. I think in the U.S. right now, we just have Ergo One and also the Round and also the Tissue Expander. That is just the beginning, the basis for our launch. We have and we've been a leader in innovation, and we have a number of products coming to the U.S. market that we have outside the U.S. We are going to be launching our minimally invasive portfolio with Preservé. That is going to be in Q1 next year in the U.S. We are also going to have the small sizes approved, which can expand our matrix. We are going to be looking at launching the Recon Indication. We are going to have that submitted at the end of this year. We will see how long it takes with the FDA. We have a huge portfolio of tremendous opportunities in the U.S., and we are going to continue to roll out that portfolio and take advantage of that momentum we have already started. Maybe I'll start by, you know, talking about how the company's grown. You gained pretty dominant share in a lot of international markets over time. Obviously, the U.S. is the biggest market in this area. I guess I was wondering if you could try to reflect on how the high market shares you've gained in some of these international countries could be mirrored in the U.S. experience over time. Yeah, I think when you look at what we've been able to do in the OUS markets, I think that the first thing it really starts, as I mentioned before, having a superior implant, you know, from the safety profile, from also from the performance standpoint. We're also leading in terms of the innovation. We're constantly coming out with new products, new technologies. When we talk about the minimally invasive, that really helps to drive our growth. We're also, as a business, fully dedicated to breast implants. I think a lot of our competitors have, when you look at the U.S., they have other types of businesses that they're prioritizing. This is all we do. You know, we're constantly looking at different ways to innovate in the industry, and you see that come into market, and that really helps drive our performance in a number of markets that we're in. The U.S. has gone well so far. I guess I was wondering if you could comment on how that's compared to your expectations. You mentioned kind of a big slate of, you know, matrix expansion next year and Recon. Could we actually see the U.S. growth accelerate next year with that? Yeah, I mean, I think, as I mentioned before, we're very pleased with the progress we had in the U.S. You know, right now we're up to 1,300 accounts. We continue to add more accounts every day. The utilization rate continues to increase in those accounts. We're very pleased. We keep on seeing it as we go into Q4. Also, the number of daily orders continues to pick up. We are seeing an acceleration going into Q4, and that's going to lead into next year. We're also going to build on that. You know, I think we mentioned in the last earnings call we're going to be adding additional up to 15 reps to continue to drive that growth next year. We also have some of the innovation in terms of, you know, Preservé launching at the end of Q1. We've done, we had some early experienced surgeons, about 36 in Costa Rica, where they got trained on it. They've been able to start using that product. It gives us a lot of learnings, and, you know, what we've seen has been very positive. That is going to help build that momentum. We're also going to get the matrix, complete matrix, at the beginning of next year. I think when you look at from an innovation standpoint with Preservé, it's just going to be starting the super cycle of innovation that's going to lead into 2027 and beyond. When you talk about the Recon Indication, we're going to be looking at getting approval on Ergo Two, which leads to the Mia launch as well. We have a lot of runway to grow just even on our base business, but we're going to continue to layer over innovation and continue to fuel that growth. We are very positive in terms of the momentum we have right now, and that's going to continue into 2026 and beyond. Could you just remind us sort of where your U.S. market share sits now, what you said about the exit rate for this year, and ultimately where you think that share could go? Yeah, I mean, I think what we communicated in the last call, you know, we expect it to be finishing the year at a run rate of about 20% market share, which I think when you, you know, you look at that over 12 months, I think it's pretty impressive in terms of how we've been able to really penetrate the market. I think that's a real testament to, you know, our ability to penetrate the number of accounts, but also the quality of the product and also a lot of the communication and marketing that we've been able to do. You know, I think it's very unique in this industry where patients are walking into and talking to surgeons and asking specifically for Motiva. I think that's really been able to help drive that penetration, and I think it's also been able to increase the utilization rate. Going into next year, I think we're going to continue to see that growth. You know, while it's hard to predict what that market share is going to be next year, we're going to continue to see strong growth, you know, not only in 2026, but also beyond. You touched on Mia and Preservé. It might be worth going deeper on those products. You know, very innovative approaches, minimally invasive. You're starting to have some success there internationally. Can you also remind us what you've said about the contributions from those this year and next, and then maybe give us a flavor for, you know, why they're so different and how that's kind of changing the game in breast aesthetics? Yeah, I can take that one. Mia is the, so we've given some guidelines around what we expect Mia to do this year, which is $8 million-$10 million. Next year we've talked about the minimally invasive portfolio in total, which is Mia and Preservé, doing at least $30 million. We are seeing very strong adoption of these products. I think at the core of them, what they really bring to market is this concept of breast tissue preservation. Being able to do a breast augmentation procedure with minimal disruption to the native breast tissue. Mia is the kind of, you know, at the upper end of what we offer. It's trans-axillary. There's no visible scars on the breast. It comes to the underarm. It uses the balloon technology. It has an injector device. Preservé uses a lot of those same tools. It uses the balloon, but it's done through a standard IMF approach. It's a bit more of a flexible procedure for the surgeon. Both of them offer, again, minimal tissue disruption, faster recovery, in most cases, no need for general anesthesia. It has really moved the industry in a whole new direction, and the adoption among surgeons, the belief in the technologies, has been really, it's happened really quickly. You know, a long time ago when you first introduced Mia, there was a focus on the market expansion that we could see from that, and you talked about expanding the market, you know, up to double, right, 50% at least. It seems like you're starting to see some of that play out. Can you talk about how that's playing out in the real world in terms of the folks who have chosen to get Mia, and do you still think it could be on that order of magnitude of market expansion? Yeah, I mean, I think it, you know, when we look at Mia, you know, as Raj says, it's also Preservé, the whole minimally invasive portfolio. I think that the benefits, the fact that for, you know, women, it's no general anesthesia, the ability to have quicker recovery time, I think that's really creating an environment where it has a tremendous opportunity to grow the market. When we first launched Mia, we really saw that as a market expanding, and it has been doing that. You know, 40% of the women that do that procedure say they were not considering any type of breast augmentation, so its ability to do that. When you launch also Preservé, it can be used in more cases, as Raj highlighted. That continues to open up the opportunity to expand the market. We're seeing that in Europe. You know, a lot of the success we've had in our direct markets has been attributed to the growth in Preservé. It's been able for us to not only increase the number of accounts that we're in, but also those accounts are seeing higher productivity as well. Related to the U.S. and your MIS portfolio are pretty powerful mixed tailwinds. Congratulations on being EBITDA positive. Crossing the Rubicon there is a big deal. You have said, you know, next year to go cash flow positive is a stated goal. Maybe you could help describe, you know, as the U.S. minimally invasive and maybe China picks up here as well, you know, how creative they can be to drive gross margins and then what you are going to do with that margin expansion. Are you going to drop it through? You know, how much are you still investing? Yeah, I think we've talked for a long time about the U.S. being, you know, the big engine for us for a period of time, right, and not only driving the revenue growth, which we're seeing in terms of the adoption, but also the margin profile, as you described, right? We have commented that, you know, for us to make an implant for the United States versus make an implant for any place around the world, the cost of manufacturing is essentially the same. The realized price in the United States is more than twice our average outside the United States. That mixed tailwind, you've seen it on the gross margin line, where a year ago we were in the kind of mid to high 60s. In the third quarter, we crossed 70%. That will continue as the U.S. becomes a larger portion of the mix. You also mentioned things like minimally invasive. You know, these are also higher margin products for us. There is a tailwind on our gross profitability. When you look at our operating expenses below that, 2025 was a year of investment. You know, we essentially stood up the U.S. commercial operation. As you look into the next couple of years, we will make some incremental investments. As Peter described, we're going to add additional salespeople in the U.S. The investment is going to be at a much lower pace than our top-line growth. Essentially, every incremental dollar revenue we generate is going to drop through at a pretty significant incremental margin. I think as the next couple of years unfold, we will continue to invest in 2026, and we'll continue to invest beyond that. The investment is going to be at a much lower rate than the top line. The profitability of this business is really going to start to emerge, I think, as we leave 2026 into 2027 and beyond. Yeah, just something to add to that as well. I mean, we look at our business as a portfolio, what geographies, what type of products, and that's how we prioritize. I mean, the resources are finite. You know, we look at obviously a lot of resources going to the U.S. because that's a key growth driver for us. We also talk about in our international markets really focusing on the direct markets. These are high-growth opportunities for us. We have much better economics in those markets. We've seen tremendous growth, you know, especially in Western Europe in our direct markets. We grew over 20% the last quarter, and that's coming after Q2, where we grew 27%. We are really making these decisions around the areas we can get the best ROI. We have a lot of discipline in terms of how we allocate resources, but it does not prevent us from making the right investments and the substantial investments like we've done in the U.S. to make sure we achieve the opportunity that exists there. Maybe you could frame for us, you know, having stood up the U.S. organization, gone through a lot of your big studies, built a big new plant in Costa Rica recently, you know, over the next few years, what are sort of the big investments that you still need to make internally as far as whether it's capacity manufacturing, you know, regulatory or commercial? It's really not a lot. I mean, the infrastructure is there. I think, you know, when you look at our manufacturing facility, we have enough to kind of, I think, to meet the demands of, you know, three quarters of the market already. We do have the infrastructure in place. Most of our investment will be in terms of, you know, in the commercial organizations to drive that growth, and in some cases also from a regulatory. I would say that the backbone and the infrastructure of the business, I think, is really well set. We do not have to look at incremental investments to support the growth. I think that's all in place. Most of our investment is going to be really to drive that top-line growth. Great. You referenced Recon, but can we talk about the importance of getting into Recon, maybe just the steps to get commercial there, and how could that complement your already growing tissue-expanding business? Yeah, I mean, I think from a regulatory standpoint, you know, our plan is to do the PMA submission at the end of this year. You know, I think it will be very dependent on the FDA when we do get that approved. You're basically really doubling the market size in the U.S. And so far, I think with FLORA, our tissue expander, it's really enabled us to get into a number of hospitals. I think we're over 150 hospitals right now, but we're not really able to maximize the revenue potential until we do get the Recon Indication. I think in order to fully leverage the opportunity, we're going to make, once we get that approval, make a sizable investment in expanding our sales force to make sure we have enough coverage to meet the opportunity in Recon. I think importantly, I'll just add to that that what we will submit to the FDA by the end of this year is part of the original PMA we've already had approved. It was when we ran that study, we bifurcated the clinical piece into the augmentation cohort and then the reconstruction cohort. What the FDA needs to review now is that patient set. They don't need to re-review manufacturing. They don't have to re-review the implant. It is part of the original PMA. It's difficult, as Peter noted, to predict how long the FDA is going to take, but it shouldn't be considered a full PMA review that they need to do. Gotcha. They are open now, I think. Good news. I wanted to go back to maybe talking a little bit more about China. That was another big opportunity that you have outlined in the past, but it has been a little slow to start. Some of that, I think, is macro and working with your partner. Where are we now in China? Sure. How could that contribute next year, and do you expect to build on that in the future? Yeah, so I think, you know, as you highlighted, the macro environment in China is quite challenging. I think overall, when we look at our OUS markets, we do see stability across most of the markets. You know, I think China is probably the one exception from, you know, a macro standpoint that is impacting, you know, specifically breast augmentation. You know, in terms of the other piece of that is also building out the capabilities of our distributor. You know, we highlighted that that process has been, you know, a little bit slower than we would have expected. We've put a lot of resources and a lot of effort in terms of building out those capabilities. You know, we look at the last quarter, we've seen some good progress in terms of building out the capabilities, in terms of, you know, looking at the sellout. You know, we're very confident that China will reach the same, you know, level of market share that we have throughout Asia. I believe it will be contributing next year in terms of revenue. I think we're going in the right direction. I think also what is challenging for us, even when we build out the capabilities, the market is a little bit challenging right now. Gotcha. The other thing that we've seen internationally in the past is there's been some areas where you've gained a lot of market share and you've actually seen the bigger competitors pull back, pull out of the markets, retract. Are you continuing to see that, and could we see that happen ultimately in the U.S. or China, for example? Yeah, I think when you, you know, it's kind of hard to predict what the competitors are going to do. But, you know, when you look at, let's say, the two largest competitors in the U.S., when it's Allergan or AbbVie and J&J, and you look at their portfolio, I mean, these are not, you know, segments that are priorities for them. And, you know, as we continue to drive growth in the U.S., continue to gain share, you know, I think it makes that business for them less relevant and less of a necessity to maintain. I think there's always that potential. You know, we're going to continue to drive growth in the U.S., and I think by doing that, it's going to put pressure, and they're going to have to make those strategic decisions. Doesn't make sense. If you do look at, and having worked in a lot of these big multinationals, that's a common, you know, that's a common process. At a certain point, they're going to get to the level where it doesn't make sense to maintain the business. When that happens, I don't know, but, you know, I think that could be a reality. I guess going back to international, you know, I think with the success you've had so far in the U.S., you've convinced a lot of investors that you're going to be a big player there. What about your ability to continue to drive growth in international, broadly speaking, where there has also been sort of a tough macro environment for a few years? Yeah, I think overall, I think the macro environment has been stable, as I mentioned. I think there are certain areas where you have good growth from a market standpoint, but there are some challenges. We highlighted China. You know, for us, we're very pleased with the progress we made this year in our OUS markets. We made a strategic decision to really focus on the direct markets. You know, these are markets, these are the larger markets. You know, when you talk about Western Europe, we have much better revenue potential. You know, we've dedicated a lot of resources, and we reallocate a lot of our resources from distributor markets to direct markets to really take advantage of the opportunities. In these markets, we have much better economics. You know, we've seen a lot of success. You know, I mentioned before the growth rates in Western Europe, 20% growth. You know, we're stealing share in a lot of these markets. We've been adding a number of accounts in Western Europe. We've added about 10% across all our direct markets. Preserve and the minimally invasive platform is really helping drive a lot of that growth. You know, for me, that's going to be, you know, a key growth driver for us. It's going to help drive the profitability as well. You know, I think we've made a lot of good traction so far, and that's going to continue in Q4 all the way through 2026 and beyond. Maybe we'll end on a few questions on the pipeline. You've always described yourselves as a women's health company. I think a lot of investors don't even know about JEM. Maybe we could start by talking about the JEM program, you know, where that is and what kind of an opportunity that could be in the future. Yeah, you know, I think we don't talk about it a lot because we have so much close in. You know, when I think you look at the breast augmentation, the Recon Indication in the U.S., I think for JEM, that's a later down pipeline opportunity. I think it could be a very sizable opportunity. We're going to be first looking at launching that in Latin America, probably around late 2026, 2027. A lot of this is going to be dependent on the regulatory pathways in the U.S. and also in Europe. I think in Latin America, it's going to be a little bit easier. I think that's going to be really after really leveraging and utilizing the opportunities we have in terms of the breast augmentation space. That's going to be something that's going to really fuel the growth in 2028 and beyond. Could you describe what JEM is, the value proposition and the unmet need it addresses? Yeah, so it's in the gluteal augmentation space, right, which is a market that is sizable and has grown over the last few years. The, you know, currently available technologies there are pretty substandard. There's not been much innovation at all. Frankly, some of the injections and fillers that are used can be quite dangerous. We are taking some of the core technologies we have in our minimally invasive portfolio, the injection device, the implants, and really adapting them to use in a gluteal augmentation approach. As Peter noted, it's still in clinicals, and we're still working through this. For what we've seen, it's very encouraging. It is really a pipeline product to really think about it contributing, as Peter noted, in 2027 and beyond. The opportunity is there. We believe we have something that's pretty unique and differentiated, and you'll hear more from us over the next couple of years on it. Maybe I'll end on a fun one. You're very popular on Instagram. Meet Raj? Yeah. The company. You have also had, you know, some signups of brand ambassadors and are doing some marketing that way. Maybe just talk a little bit about that strategy to get recognition of the brand and kind of the buzz that is being created by some of the online marketing. Yeah, I think, you know, especially you see this in the U.S. I mean, we did the Meghan Trainor campaign. That's been tremendously successful for us, not only to create the interest. We've been able to track the number of patients that have come in specifically on that program. Also, I think we've just overall been able to create a lot of buzz in the industry. Some of that is driven by us, and a lot of it's driven also by the surgeons. You know, I think in some respects, there really hasn't been, you know, a lot of innovation coming to the market in the U.S. I think once we came in and we provided a lot of materials, I think, you know, along with the things that we're doing, the surgeons are also very excited about it. You see them doing a lot of posting and reposting. I think that's really been able to drive a lot of the growth. I think for us, it's very unusual that you have patients walking in, talking to surgeons, and asking specifically for Motiva. You know, we're very proud about the efforts. That really helps us to drive the penetration and the utilization rates. That's going to continue into 2026 and beyond. Great. I'll be waiting for my contract. I'm not sure you're the right target, though. All right. Thank you guys for your time, and thanks everybody for your interest in this action. Thank you. Thank you.