Good morning, everybody. Thanks for joining us here for our first session in the MedTech track. I'm Matt Taylor, the U.S. Medical Supplies and Devices Analyst here at Jefferies. I'm joined by the management team on my left here for Establishment Labs. We have Peter Caldini, who's the CEO, and Raj Denhoy, the CFO. We'll have about a half hour for moderated Q&A. I always like to start at the high level, and especially for these conferences, there could be folks who are newer to the story. Maybe you could just start with a little bit of an overview of your portfolio, talk about how your products are differentiated, and maybe give us a look at the pipeline and some of the stuff you're excited about coming down the pike. Yeah, thank you, Matt. It's a pleasure to be here. Regarding your question, I think the broad portfolio that we have on a global basis, I think what's really driven our success outside the U.S. and what I think is going to be a key driver for our success in the U.S. is that we have a portfolio of differentiated products that are really unmatched in the industry. We have the safest products that's really supported with clinical data. In the U.S., we have our five-year data from the FDA study that supports that. It's a far superior safety profile than what's in the market. Also, we're the real leaders in innovation in the industry. What we've been able to develop really outside the U.S. is a wide spectrum of products, from our Round product to Ergo, to Ergo2, to our minimally invasive platform that contains Preservé, as well as our premium product, Mia. Each one of the products creates value and differentiation at different price points. They are all really founded and really built on superior performance and superior safety. In the U.S., where we are today, it is really the early stages. We have our Round and Ergo1 product in the market. Over the next two to three years, we are expecting to launch really a super cycle of innovation. We are going to have the recon indication. We are also going to be launching Preservé. It is part of the minimally invasive platform. A little bit further out, once we do the PMA supplement for Ergo2, we will be able to launch Mia. All this will be in the next two to three years, which is going to enable us to build a very strong business in the U.S. We have already a best-in-class organization, and we're seeing a lot of success in the market. It is really going to kind of build out that portfolio. Fantastic. Maybe we could start, again, high level on the market a little bit and talk about some of the key trends there. There has been a lot of investors talking about macro pressures and how that could impact consumer discretionary purchases. I would love to just get some insight into how the market has been growing, how you are doing within it, what you think the outlook is for the market. Yeah. I think that's a fair point in terms of the OUS market. In general, in what we've seen, it's been pretty stable. Obviously, there's a lot of uncertainty around the macroeconomic situation, especially with the tariff discussions. As I said before, we haven't seen a real impact in terms of the level of procedures. I think this is more of a lagging indicator. It's something that we're staying very close to and also put ourselves in a position to course correct when we do see changes in the different markets. I would say, so far, we haven't seen any material impact to that. Obviously, we're very close to it. You look at the different regions, I would say Asia-Pac for us is stable, and we're seeing pockets of growth. I think we highlighted in the earnings call, China's a market that we had a pipeline fill last year, and we're not looking to get any sell-in for the first half, so probably in the back half of the year. In Europe, I think it's a stable market. We see areas where we're having good growth, and we have some challenges. Very happy with our performance in the U.K. and Spain, also in some of the distributor markets such as Poland and Russia. We're really gaining share in those markets. What's really helping us drive the business, what we're very confident in for 2025, is as we roll out the Preservé minimally invasive products. There's very strong interest. We started that rollout at the beginning of this year and it continues to have a lot of interest. That is going to help drive our business in Europe. For us, Latin America has been probably the biggest challenge over the last 12 to 18 months, in particular when we talk about Brazil. However, we have seen some stabilization in that market at the end of last year. I think we are also launching Preservé there. We are going to see some sequential growth, but I think that still continues to be a market and a region overall that is a little bit challenging from a macroeconomic standpoint. Great. As a reminder, you guided to a mid-single-digit growth guide in 2025. Maybe you could talk a little bit about how that guidance was constructed and how confident you are in hitting the high and low end of the guide, given the trends you saw in Q1. Yeah, I think as Peter noted, we continue to be very vigilant to any changes in the underlying market conditions. Thus far, we really have not seen anything meaningful at this point. The overall guidance of $205 million-$210 million, roughly 25% at the midpoint, we are still very confident in those numbers. Again, our philosophy around this is to be conservative and see how things play out over the course of the year. As we sit here today, we remain very comfortable with the outlook we have given. Now, and part of that has been the strong performance in the U.S. Obviously, that's a big focus for investors. You talked most recently about 900 accounts, and it seems like you've been adding about 100 a month. I was curious if you could talk a little bit about the ramp in the U.S., how things are doing there. You said on the last call that you were confident that you could get some upside to the guide, but it seems like you're still remaining conservative there. We'd love to get any more. If you want to give us a new account disclosure, that would be great. Yeah, so we probably won't. Okay. I think we gave a lot of details in terms of the performance, and we did that for really to make a lot of the investors feel comfortable in terms of where we're tracking with the business in the U.S. What I can say is we continue to be incredibly happy with the performance there. It continues to exceed our expectations. We've added additional accounts. We've got onboarded additional accounts. They're ordering, increasing our average sales on a daily and weekly basis. What we mentioned in the last earnings call, I mean, we're not going to continue to provide that information. I think, as I said before, that was something that we shared just to give people comfort in terms of the progress. We continue to be very positive and bullish with our opportunity in the U.S. As I mentioned before, I think we have a great product, but I think we're really coupling that with the tremendous organization. I think it's a best-in-class organization we have in the U.S. We feel very confident with the guidance we've provided and then certainly exceeding that. Yeah, I'd love to hear more about the organization, because I have heard qualitatively that you've brought in a lot of really good salespeople and have been able to get talent from some of your competition. I would love for you to give some texture to that and maybe talk about the type of folks who are coming over, why they're attracted to this, and how much of a difference a good commercial organization like that can make. I think, first off, as I said, I think we have a best-in-class organization that has a lot of experience in the industry. I think when you look at the competitive set and the companies that they are coming from, it is not necessarily a priority to them. I think that they saw Establishment Labs as a company that is dedicated, focused to the aesthetics space, and they saw this as a tremendous opportunity. I think because of that, from Jeff Ehrhardt and to the leadership team down, we have been able to attract some of the best talent in the industry. I think that obviously has a huge benefit. I think they have established relationships in the marketplace. They know what good looks like. I think that is critical for us. I mean, we are doing everything from the ground zero. I think when you have a leadership team there that knows what good looks like, I think it's been very easy for us to assemble what we think is the best operating models in the U.S. For us, I think that is one of the key drivers for our success. I mean, it's not only the products that we have and the safety profile. It's also the capabilities of the organization. How would you compare how the U.S. launch is going versus some of the other markets that you've launched in historically? Has it been easier to take share, harder to take share? Is it similar? What's different or similar about the U.S. versus some of the other analogies? I mean, I think the first thing, I mean, every market is a little bit different from the competitive set in terms of the trends, in terms of the market dynamics, and I think also ultimately in terms of the capabilities. I think when you look at outside the U.S., I mean, we're in close to 90 different countries, and I think we have a leading share in a number of those markets. I think what really determines the success in a market is if you have a superior product that really meets the demands of the patients as well as the surgeons, and you couple that with very strong organizational capabilities. I think that's what we've done in a number of markets that we've had overseas. Because of that, we've been able to attract a dominant share. I think in the case of the U.S., I think that mirrors that. I think that's why we're very confident with our existing products as well as the pipeline that's coming, that we're on track to becoming a leading player in the U.S. market. Can we just compare that to China for a second? You mentioned before that you had the sell-in in China last year, and we're thinking in the first half of this year, we're going to have much of that repeat yet. Why has China been slower maybe than I would have thought? How do we think about the ramp in China over the next few years? Yeah, I mean, I think in China, obviously, it's not a direct market for us. It's through a distributor. I think those are decisions that we made based on really the resources that we had, both financial as well as organizational. I think in the China market, not having full control and going through a third party, they're also building capabilities in that market as well. I mean, it's a huge market. It's not an easy market. It requires a lot of resources. There is also the backdrop a little bit in terms of what we're seeing in terms of the market. It's not as progressing as much as I think we originally planned. What we've seen with our distributor is they continue to build up their capabilities, that we're seeing good sequential growth quarter over quarter. We're very confident that's going to continue, but it's going to be a longer process. Maybe talk about the choice to use a distributor there. This is one that you know. And as a reminder, they made a big investment that was announced alongside the company in Q3 of last year. So can you talk about some of the capabilities they're building? Yeah, I think, I mean, whenever you go into a market, you need to assess, are you going to do it direct or are you going to do it through a distributor? A lot of that boils down to what is the financial requirement, the financial resources required to do it, as well as your organizational capabilities to do it. Quite honestly, anytime you make an investment in a direct market, which we've done in the U.S., it's a significant investment from a financial as well as organizational. For us at the time, evaluating the opportunity, we felt that it was best suited to go through a distributor so we can really allocate and dedicate our limited resources to the U.S. to also driving the innovation pipeline. Generally, Matt, in most of the markets outside the U.S., we generally start with the distributor, get established proof points, and then over time, we acquire that distributor. For us at the time, I think it was the right approach. We continue to think in terms of our priorities and how we want to manage the resources, the limited resources we had, it was probably best to go through a distributor. Maybe switching gears, I wanted to talk a little bit about Mia and Preservé and these products that you've talked about being market expanding. You're now guiding to, I think, $8 million-$10 million for Mia this year. I guess could we talk about the two products, how they kind of compare and complement each other? Sure. I'd love to hear any proof points about how you think they've been market expanding to date. Yeah. So Mia, we're very happy with the progress. I think we mentioned in the last earnings call the number of cities, and we're in 75 clinics. That continues to expand. We're really seeing good progress on the Mia business. I mean, just keep in mind, we haven't been in the market for a long time, but we continue to build that out. What we're seeing in terms of market expanding is in our studies, close to 40% of Mia users are patients that really never considered a breast augmentation. I think that really demonstrates that it's certainly market expanding. Also, we get very positive NPS scores, customer satisfaction scores. I think it really demonstrates the potential of that market. Where we see a huge value is really looking at this on a broader basis with the minimally invasive platform with the launch of Preservé. Preservé is really something that can be used across more procedures. It really expands the market. You can have larger cup sizes. You can have mastopexy. It is more procedures. It is also available to more clinics. It is a process that I think a lot of the surgeons are already accustomed to. We are really using Preservé to complement what Mia has and really build out the minimally invasive platform. As I mentioned, we rolled that out in Europe earlier this year, and the interest has been extremely strong. Also, we did that in Brazil, and we had very strong interest, I mean, in some respects, more than we expected. A little bit of a scramble to make sure we have the right supply. I think this is really the wave of the future, minimally invasive. I mean, you see that across a lot of different procedures. I think we're really on the forefront. I think combining Preservé with Mia is for us the right way to do it. Just wanted to be clear on the $8 million-$10 million. Does that include Preservé or not? No, that's just Mia. Could Preservé be material this year or next? I think our expectation, it would be material this year. I think it's going to help drive a lot of the growth that we have in some of our OUS markets. Gotcha. I'd love to touch on Recon as well. You mentioned before that as part of the supercycle of innovation. I'd love to hear more about where you are with the tissue expander. I know you've been getting into some accounts there. Could you talk about the pathway for Recon in general and when you would expect that to be a contributor? Yeah. As we mentioned in the last call, we're in 60 accounts. We're going through the VAC process in another 100. We continue to expand that business. What we're trying to do, Matt, is to really get a presence in maybe one or two key institutions in each of the geographies just to have a really strong presence. Most of our focus in the sales organization is really around the Aug business because we don't have currently the Recon indication. We're trying to do a lot of this to set up so we have a good foundation when we do have the Recon indication. Where we are with that is we're going to be getting our three-year data during the summer. We're going to be filing soon after that, the end of this year. Obviously, it's very dependent on the FDA, the timing, but we would hope to get Recon indication back half of 2026 or the early 2027. A lot of that is going to be very dependent on the FDA. Great. Beyond Recon, can we talk a little bit about the GEM program and anything else you would highlight in your pipeline? Yeah. I think in terms of the pipeline I mentioned, on a global basis, we have a number of excellent products that still really have not entered the U.S. I think we're going to have a nice pipeline of innovation over the next two to three years. I think beyond that, GEM is something that we're very excited about. It's still very early stages. We're going to be looking at going to market really in a test basis in some of the Latin American markets where I think the approval process is going to be a lot easier for us. We really want to test out the concept, build out the capabilities, and really understand the go-to-market, what would be the most effective before we start introducing that in some of our bigger markets. That's some of the innovation we've talked about. There's other innovation that we haven't really talked about. I mean, this company is built on innovation. We continue to drive that. I think for the next two to three years, we have a lot that we can use to continue to drive growth. It's really going to be about our ability to execute and putting together the best organization to do that. Maybe going back to the market, could we talk a little bit about the competitive set and anything that you've seen change with competition? I know Sientra's had some challenges and has changed hands. Are you seeing anything different from the larger companies or innovative? Anything changing the landscape? No, I mean, I think, listen, I think in general, we would say we haven't seen a real concerted effort by, let's say, the two major players. I mean, there's pockets of activities. There's a lot of claims that are being made by different sales reps. I think in certain cases, they've been pushing in terms of some pricing activity. But so far, we haven't really seen, we've seen some responses, but I would say it's not been to the level that's aggressive enough and it's concerted that it's really impacted our business. I think we continue to be very confident and bullish in terms of what we're doing. We'll see over time if that changes. Obviously, as we start penetrating and get more share, I think that creates greater threats and then probably more aggressive responses. How have you been able to do with price in the U.S.? We've heard from some of our checks that you're at sort of a modest premium, kind of a mid or high single-digit premium. I would love to hear about pricing internationally too and how that's holding up. Yeah, I think the pricing is what we've always wanted to do is have a slight premium versus the competitive set. That's how we try to do it, not only in the U.S., but in a lot of the OUS markets. I think we believe we have a far superior product, superior safety profile. We are the leaders in terms of innovation. That really warrants that premium pricing. Obviously, where you do run into some challenges is depending on how the competitors react to it. If they're going to react to a significant price discount, then you really have to say you have to look at and value it in a particular market. Does our product warrant that type of premium? What we really try to do is just avoid any type of price competition because I think that erodes the real capabilities, and what we are all about is focusing on a superior product with a superior safety profile. Gotcha. Mia is sort of a different animal. Can you talk about how you're able to price that and what that means? I want to get into some margin discussion with Raj too. This is all sort of a team. We can handle the pricing stuff too. Yeah, maybe talk about Mia and how that package compares in terms of the economics you're able to extract and what it means for the margins. I think as Peter noted, if you look across the portfolio from Round, Ergonomics, to Ergonomics 2, to Preservé, and up to Mia, right? At every step along the way, there's additional value for the patient, to the surgeon. And we as a company benefit from higher ASPs and higher gross margins. There's no sacrifice as a patient moves down. The Round implant has all the same surface technology, the same construction. There's no compromise one needs to make. And surgeons and patients can select as they want to along that path. As Peter noted, in the U.S., we have the earliest part of that. We have Round and Ergonomics. We have these other steps still to come. You asked about Mia. I mean, Mia is at the upper end, right? There is no visible scar. There's no general anesthesia. Patients are in and out in 15 minutes. It's a very unique offering. We price it as such, right? As noted, we are seeing good traction. We've been in the market for less than two years, and we'll do $8 million-$10 million, as we mentioned this year, and it's growing very nicely. I think having that portfolio and really that spectrum of products and allowing both surgeons and patients to select where they want to be is the right strategy. Furthering the margin discussion. You've talked about some goals now to become EBITDA positive by the end of the year, cash flow positive. Maybe talk about your confidence in those goals and remind us what's driving the profitability this year and your ability to achieve that. Yeah, I think to the question on the confidence, I mean, we are very confident. It has also become, I think for us as a company, these are goals which are as important as achieving our revenue targets and other things, right? It has become really part of what we're really organizing around is delivering on these profitability metrics we've put out. If you think about what drives it for us this year, it's a couple of things, right? It's the U.S., right? The U.S. revenue is increasing very rapidly. We've talked about meaningfully exceeding the $35 million number we've given for this year. The margin structure in the U.S. is significantly higher than outside the U.S. We've talked about the realized pricing for us on a blended basis in the U.S. being more than 2x what it is on a blended basis outside the U.S. where we're in a lot of distributor markets. We're realizing much higher prices in the U.S. The cost of making those products is essentially the same. It comes out of the same facility we have in Costa Rica, and there's not a lot of differential in that cost of goods. That significant gross margin increase is then married with an operating expense base that we've talked about being relatively static over the course of the year. We made the heavy investments in the fourth quarter of last year and the first quarter of standing up the U.S. operation. We have the 40-plus salespeople. We have our office in Austin. We have the back office function, the sales management team. There will be some incremental increase as the business scales in terms of shipping and other types of variable costs, but not significantly. As the revenue increases, your operating expenses are relatively stable. That is what drives us towards that EBITDA profitability in the second half of this year. We remain very confident in our ability to hit that. If you look at below that, the big expense items for us are really the interest on the debt we have and then what happens with working capital and CapEx, which are generally stable. As the revenue continues to grow into next year and we are leveraging those other two major expense lines, we see a pretty good line of sight to cash flow break even at some point next year as well. Yeah, I mean, one thing I would add to that, what Raj said, I mean, I think there's been a lot of great work done over the last 12 to 18 months in terms of really right-sizing the business, right-sizing the corporate infrastructure, and just instilling a very strong discipline around financial management, operational discipline to really create a lot more efficiency in terms of how we operate. I think we're starting to see the benefits of that this year. We're going to continue to look at ways how can we, as you scale a business, you have to operate very differently than you do when it's a small company. I think we're instilling that discipline in the organization. We're seeing those benefits. As Raj mentioned, we built out a structure in the U.S. that was quite expensive. We have top talent and putting together the best infrastructure while at the same time really reducing a lot of expenses. It really did not have a material impact. I think as we continue to grow from a revenue standpoint, higher margin products as well as higher margin markets, I think that is what is really driving that mix. I think as Raj said, I mean, it is really a combination both of revenue-driven and higher gross margin markets and products as well as how we are being very disciplined in how we manage our expenses. You referenced this, but that mixed flywheel should stay kind of in your favor for a long time here with the U.S. and Mia and all these things that are coming. I know you have not really committed to this on an annual basis, but could you talk about kind of the quantum of margin expansion that we could expect year in and year out? You are still a growing company. How do you balance the desire to deliver leverage and earnings growth with investments that you want to make to continue to grow the top line? This year we have committed to 200-300 basis points of gross margin expansion, right? Again, we feel very comfortable with that outlook. We saw a nice margin expansion even in the first quarter. As the U.S. continues to build over the course of the year, that's what's going to drive that number higher. We haven't given much beyond that. As you noted, you look at what is coming in terms of Preservé, Mia, Recon, continued growth in the U.S. These are all margin accretive endeavors for us, right? There should be a continued tailwind to our gross margin over the next several years. Raj, maybe talk about balancing that with growth. Yeah, so I think the balance there is, as Peter noted, and I tried to highlight as well, I mean, achieving these profitability targets for us are kind of non-negotiable in a way, right? I mean, we will get to be EBITDA positive this year and we'll achieve cash flow break even next year. These are things that are as important to us as driving the top line. I mean, we honestly hope to be in a position where we have to make those kinds of decisions as to what we want to invest and where we want to let the flow through, but we need to cross those lines first. Those are really kind of hard targets for us and we expect to achieve them. Yeah, I mean, I think, Matt, it's all about choices when you're running the business. I think to use an example, when you asked regarding China, I mean, we could have gone direct. There are a lot of resources tied to that. These are choices you make to kind of say, all right, you have limited resources. Where are you going to effectively allocate that? Where can you benefit from that, make a different decision later on? I don't think there's been any situation that we've actually reduced investment on something that we believe is a key priority to drive the business. That's why I think we've been very selective in terms of how we do manage our expenses. As I said before, it really boils down to choices, but you have to make those choices. Very good. I think that's our time. Gentlemen, thanks so much for your time. Thanks, everybody, for your interest in Establishment Labs. Thank you.