Okay, thanks everybody for joining us this morning. Matt Taylor, the U.S. Medical Supplies and Devices analyst here at Jefferies, and I'm pleased to be joined by management from Establishment Labs here. So to my left, we have Raj Denhoy, the CFO of Esta, and also Juan José Chacón-Quirós, the CEO and founder of the company. So this will be about a 24-minute now Q&A. Then I'll start with some fireside chat questions, and then at the end, we'll have some time for the audience to ask a few. But JJ, maybe to start, I would love for the uninitiated here, if you could give a little bit of an overview of the company, maybe how it was founded, and talk about your progress to date. Maybe bring us up to speed with where we are, up to the 8-K this morning. But no, go ahead. Let me open the floor for just some high-level comments, and then we'll get into some details from there. Yeah. Thank you, Matt, and, I'm the company founder. I founded this company because I believed that there was an opportunity to transform the most common indication in plastic surgery because the technology that was given to the plastic surgeons was not working in their favor, it was actually working against them, and definitely putting patients, women, in a situation where they had unacceptable device-related complications. What we have done since our founding, which is now almost 20 years ago, is to bring technology to plastic surgery, and what we've been able to prove is that this technology can drastically reduce device-related complications, most importantly, capsular contracture and also rupture. We've reduced those reoperations due to those two complications to a level that has never been seen before in the industry, and we will continue to work with many of our innovations to make that even better in terms of the outcomes that we can create for women. Thank you. And so, that safety advantage and also your focus on aesthetics and breast aesthetics has really led you to have a lot of commercial success in many countries around the world. So maybe we could start with talking about some of the proof points in the international markets, and I guess maybe you can give us a sense of where you stand with market share and how you've been able to compete in a number of markets globally today. Yeah, I think we have a very clear blueprint of how we do this, and, you know, over the last 14 years now, since we went to market, what we do is, first of all, work on the plastic surgeon partner part, in which we are constantly bringing these new technologies. So they're, you know, we're required to provide medical education to help them upgrade their practices. And, then the other part of it, in which we are very good at, is in countries in which we can compliantly speak to women directly, we educate them on these technologies and what it can mean for them. So I'll just give you some examples. You know, when we went to market in 2010, the average size of an incision in an aesthetic breast procedure was 5-6 centimeters, and it was not uncommon to see 7 or 8 centimeters. We are now currently, with most of our technologies, you know, doing those incisions at 2-3 centimeters. That is something that is very important for women who are electing to have an aesthetic breast procedure. The other part is, you know, moving the implant from behind the muscle to, you know, where it should be, you know, under the gland. And that is very important because, you know, for many women, surgeons have to choose the submuscular plane to be able to reduce the capsular contracture rate, but not because it's best for them, it's because the devices that they're using cannot allow for that. So being able to provide these choices for women is what makes our company so successful, because then there's, from the plastic surgeon part, you know, this push towards technology that we are bringing, but also, you know, the pull from women who are asking for it. And that's how we gain market leadership in every single market. It's not overnight. It takes several years. You know, we're educating surgeons, we're educating women, but eventually, people get it. Maybe it makes sense here, since you're talking about improvements in the procedure and the options that you're giving women, to talk a little bit about Mia and the early success that you've had there, because the last couple quarters you've come out with disclosures about this minimally invasive procedure and signing up a lot of new centers and marquee centers. So can you talk about, A, what Mia is, and B, the progress that you're making with the rollout? Yeah. So as part of, you know, all the things that we've done, we eventually realized that one of the things lacking in, you know, aesthetic breast surgery was a minimally invasive approach. You know, over the years, many surgeons had worked to be able to do something that looked like minimally invasive, but they just didn't have the technology for it. So what we did is we created a new type of implant with a new type of chemistry, still silicone, but it's more in the realm of the super silicones. So this type of chemistry allows for this implant to be actually injected. So what we do is, basically, we create a very small incision in the axilla, and then we can, you know, use a balloon to create the space and safely inject an implant. These procedures are done under 15 minutes, no general anesthesia, and basically, it breaks a lot of the barriers that a lot of women who are currently using compensatory behaviors, like padded bras, push-up bras, have towards, you know, aesthetic breast augmentation. And it's having a big impact because a lot of people wanna talk about this. You know, the fact that now you have minimally invasive in breast is going to expand the market, and we are seeing that already in the cities in which we have launched Mia. ... And maybe I'll just double-click on that. So you talked about an aspirational goal to sign up about 100 centers by the end of the year. Can you talk about the center progress? And then, on the last call, you also mentioned that some of these were getting up to a million-dollar runway. So maybe talk about the commercial success and how you think these centers will be, you know, productive and producing over the next few years. Yeah, I think one of the most important things is that you understand our aspirations with Mia. So Mia is a city-by-city approach. We go into a city that is, you know, having a lot of breast augmentations taking place, and what we think is that Mia can expand the market for breast in that city. So we've been doing this, you know, around Europe, Japan, and now we've started expanding into the Middle East. And, you know, what we are looking for is partners that have the capability to reach this new type of consumer. This is a new category play, so because we're creating market expansion, we have to have the right partners. And what we are seeing also is that some of these partners are starting to trend towards this, you know, again, aspirational goal of an average 24 procedures a month, which, you know, in direct markets means that it becomes a $1 million account for us. And, you know, if we can do this quarter to quarter in the cadence that you've been seeing, Mia eventually becomes a big thing, not only for Establishment Labs, but also for breast aesthetics. Okay. So I wanna make sure we address the 8-K in the room. So there was an 8-K this morning, if people didn't see it, talking about U.S. approval pending a successful inspection. So we'd love to get an update from you on, I guess, when the inspection could occur. It's in the next 30 days in the 8-K, and any other color that you can give about the approval process at this point. Yeah, I think, you know, I'll try to give my perspective so that you understand how important that is to the company. We've been working on this PMA for about 8 years, from the design process going into the approval of the IDE, you know, the clinical trial that has been ongoing, the release of data at 2, 3, and 4 years now. You know, we chose the modular path in which each one of the 4 modules was being reviewed by the FDA. So the fact that the FDA sent us this letter, deeming the PMA approvable, pending, you know, the inspection, it's a big thing. It's a big win for Establishment Labs. It means also that we have significantly de-risked the final approval because now all the discussions around the clinical data, all the discussions around labeling, the post-market studies, all of those are finalized. Now we just need to do the inspection, and I can tell you, you know, that's a facility that has been inspected by high vigilance authorities from around the world, you know, so many times. Just recently, we had our MDSAP inspection. That basically is, you know, basically a compounded inspection that includes, you know, FDA regulations, Health Canada, ANVISA from Brazil, and also some of the other countries in Asia-Pacific. So that is significant because it means that, you know, our team is ready, is well-versed on this. I mean, we've been having inspections for the last 14 years, and, you know, we've conducted mock inspections with former FDA inspectors, and, you know, our team is ready. We had a slight delay because, you know, people do get sick, and the inspector got sick, so it got to be, you know, to be moved, but we're ready for it, and it's really the final thing. Great. I guess you talked about a couple of the reasons for investors to have confidence in the inspection going well. Maybe you could talk about the odds of success, anything that could go wrong, or do you feel like you've really done everything that you can to prepare for this? Just 'cause it's so critical for the U.S. approval. It is critical, absolutely, and our team is ready. And I—like I said, you know, we haven't been preparing for this for the last few months. We've been preparing for this for the last 14 years because that's, you know, the process of inspections that we've been ongoing for, you know, for throughout our life as a commercial company. This is not a first for us. You know, our team is prepared as well in some of the things that could go wrong and, you know, have been working through those. That's why we had the mock inspections, that's how we went, you know, through everything that could go wrong. So you get prepared for it, and I think we're very much looking forward to the inspection and especially to bringing this technology to women in the United States. Of course, you did get approval in another big market last year in China and have started to ship in the first half of this year to distributors there. Maybe you could talk about how that's going and review expectations for what you think would happen commercially in China this year and a few years down the road. Yeah, I think to put it into context, China is the most dynamic breast aesthetic market in the world. It has some of the highest ASPs in the world, and, you know, it has a lot of potential, so definitely is a market that we needed to be in. We have started since January on a campaign of medical education across Tier 1 and now Tier 2 cities. We've started to increase the awareness level in, you know, in potential consumers in China. We have a competitor, you know, who's FDA approved, that is currently at 70% of market share in China. So of course, we're gonna fight to preserve that, but I think we've been really good at doing this in other countries in Asia over the last few years. I mean, we're market leaders in countries that have a significant Chinese population. You know, Taiwan, of course, Hong Kong, Singapore, and Malaysia. So these are important, I think, reference points to what we can do. And of course, you know, in South Korea, which is a reference point for aesthetics in China, we've been market leaders for many years. So I think, you know, this again, doesn't happen overnight. It happens over several years, but, you know, definitely we are working to making that also a reality in China. ... And on China for this year, can you just remind us what's in guidance and how that's gone so far with the commercial rollout? You know, as Juan has noted, the rollout is going well. You know, our distribution partner there is opening up new cities and customers, you know, as we're unfolding in the year here. The guidance that we gave for this year was approximately $10 million. And when you think about that, that is the initial stocking that distributor is doing into China. You know, once that stock is established, then they will start to sell out that stock to customers for procedures. As that happens, there will be a cadence of reordering. You know, it's that reordering piece that we still need to understand as that market, you know, fully opens up. But at this point, you know, that guidance we've given for the year for that initial revenue is very much on track. Raj, could you just talk about how a new distributor market typically reorders? Like, what's a reasonable pattern for people to think about? Again, it varies, right? And I think, you know, China's unique in just the size of that market, you know, just the scale of it. You know, even that initial stocking will not open the entire country for that distributor, right? So there'll be additional activity that happens there. But you know, typically, distributors hold between six and nine months of inventory, and then they will work through that, and we'll get orders, you know, sometimes a couple of times a quarter, sometimes only once a quarter from distributors. So they'll. It all varies. It's all very different, you know, depending on the distributor and how they run their business. Gotcha. And then with the other big market, the U.S., you know, assuming we get an inspection here in the next 30 days, what should investors expect for approval timeline now with this announcement? Does that speed the process post-inspection or the official approval? Well, I think the most difficult part of the, you know, PMA process is done. And, you know, you saw us hiring our GM for North America, Jeff Ehrhardt, and, you know, Jeff is very well-versed, used to run, plastic surgery for Allergan, and, he's putting together a team. And Pugh is, you know, our head of sales for the U.S. So of course, there's currently a process of getting game ready, and we will be game ready for, you know, for the moment we get approved for, you know, for commercialization in the United States. You know, we are being, of course, mindful of how we do that. It's going to be progressive, but we are going to be able to, you know, have all the operations, in terms of logistics, invoicing, all of it, ready. I mean, we are already doing that for the tissue expander, Flora, which is already in use in the United States. Gotcha. And then I guess in terms of timing, so if you do get inspection in the next 30 days, previously you've talked about it could take up to 6 months after that to get the official approval. Is that still the timeline that we should think about, or is it any different now? Well, I think what the approvable letter means is that you don't have that anymore because you don't have... I mean, that, that meant that you would go into, you know, discussions on, you know, your clinical data, discussions on labeling, discussions on post-approval studies, and the approvable letter means that you don't have that anymore. So really, you know, save any, you know, any response that you have to give post-inspection, basically, it is done for. So we are really at the end of this. Gotcha. Okay. And then, so I'm making this up. Let's assume we get approval sometime this year. I just wanna understand, post the official approval, how should investors expect the ramp to be in the U.S., which is not a distributor market, so you're not gonna have as much stocking. We are getting game ready. So maybe give us some thoughts on how the ramp would progress from T plus one, you know, once you get the approval. Yeah, I think importantly, you know, with the increasing visibility on the approval, right? We are taking the steps to be ready on day one to begin selling in the United States. The reality is that there is a ramp-up period. You have to onboard customers, you have to put inventory into the channel so those customers can use it. So people should be mindful that it'll be a ramp for a period of time. But, you know, as Juan José noted, you know, if you go to our LinkedIn page, we are hiring in the U.S. You know, we're adding salespeople, we're adding sales management, we're adding marketing people. We're gonna be ready to go on day one, and the inventory will be in place. with this increased visibility, we're taking advantage of it, and we're gonna be ready. Great. A couple other things I want to ask, and then we have some time for questions. So first, you mentioned Flora before. That was a nice approval that you got last year. We haven't heard as much about it commercially recently, but maybe you could update us on where you are in getting that into new accounts and any color that you can give on the uptake of Flora. Yeah. So the tissue expander market in the United States is significant. It is the number one in the world, and it has the highest ASPs. For us to bring Motiva Flora, which is a truly differentiated technology, I mean, do remember, it is the tissue expander that allows hospitals to give MRIs to patients in the process of the breast reconstruction in the expansion phase. So that changes protocols for hospitals and can potentially reduce the radiation oncology levels. That's why we started with a center of excellence approach. We started with MD Anderson, so that as they change the protocols and, you know, bring that to light, you know, more and more other institutions would come through the door. We've talked about, you know, being in process, in the VAC process, with 15 institutions. We continue working through that. You know, it takes time, again, and we're not trying to rush it. What we are creating is a new standard in, you know, breast expansion for breast reconstruction. And, and that's why we're being conservative and patient in the way we do this, because it's not about just, like, taking market share from the existing market, it's actually creating a new space in which we can significantly improve breast reconstruction for women in the U.S. So what I would say is, as it becomes, you know, material, we will talk more about, you know, what that contribution is, but at this point, it's more on the qualitative side. Maybe I'd ask you just to comment on the overall environment, since that's been risk point's been a little softer macro-wise with rates being high and around the world, since you're in so many different countries, there are some countries that have been struggling. So would love to get an update on sort of where we are, if you've seen any change in trend, and how the macro conditions are in general for your customers. So I think we've been pretty consistent in our view that, you know, the worst is behind us. That, you know, markets are in the process of stabilizing. I think some regions are, you know, getting faster there than others. Latin America continues to be a challenge, especially Brazil, but, you know, we expect that improvement to continue to take place throughout this year. I think we, you know, already in Q1, we saw that the mix of distributor to, direct markets, was more akin to what we call normality. But we still think that, you know, overall, you know, we haven't seen a full market recovery in breast aesthetics. So again, we have all these product launches taking place around the world, with Mia, you know, the Ergo 2 platform is getting approved in more countries. So that allows us also to bring new products at different ASPs, which can make up for, you know, reduced demand in terms of number of procedures. Great. And so with a couple of minutes left, maybe I'll ask if there's any questions in the audience, and if not, I have a number of additional questions in my secret binder here. Any audience questions? All right, so everybody's shy. So just to clarify, once the inspection of the facility's complete, if all goes well, you're approved, that six-month window is gone? So once you get a green light from the facility inspection, you would be able to commercialize the product in there? Yes, that is correct. It's, there's paperwork, but yes, you are correct. Congratulations. Thank you. Okay. Any other audience questions? So maybe I'll ask one on margins and the cash flow. So, Raj, you talked about this goal of being EBITDA positive by the end of this year and getting to cash flow positive next year. So maybe talk about your confidence in that and the steps to get there. That's the first one. We can- Uh- Keep it simple. Yeah, sure. I think if you looked at our first quarter numbers, you know, we saw a very dramatic improvement in our EBITDA loss in the first quarter. You know, as we look over the course of this year, we expect that will continue to improve, and the guidance has been that we will get to be EBITDA positive by the end of the year. I think the important aspect to that, though, is that that is excluding the United States. So as we start to spend in the U.S., that could push the timing of that EBITDA profitability out by a couple of quarters. But the reality is, as it relates to our cash flow, which you're referencing as well, on FDA approval, it unlocks additional capital to us through our debt facility. When one thinks about our cash position, it will actually be higher than it would've been without the U.S. approval. In a sense, the spending will increase with the U.S. approval, but so will our cash position. We feel we're in a very good place to again achieve that EBITDA profitability in the business outside of the United States by end of the year, and for the entire business next year, including the U.S. Our cash position as we currently have it and with what's accessible to us, we think we have a very good line of sight to the overall business being cash flow positive by the end of next year. Very good. And also related to this, I wanna ask about gross margin specifically, because you have a lot of gross margin drivers with you entering these premium markets, and then also Mia being a premium when with that math you gave before. So maybe talk about the mix effects on gross margins. I'd love to hear if you could give us a framework for how to think about that over the next couple of years. Yeah, I mean, if you look at, you know, everything we've been talking about, for the last 25 minutes, you know, in terms of, the U.S., China, Mia, Flora, the Ergonomix 2 platform broadly, you know, these are all higher ASP, products for us, and in some cases, significantly higher. You know, the U.S. is the highest priced market in the world. China's the highest priced distributor market in the world. We've talked about the Mia ASPs, you know, being in a direct market north of $3,000 per procedure. And yet the cost for us to make a, an implant in our facilities in Costa Rica does not change much. And so when you think about the dynamic of the business shifting to more direct with the U.S. and a higher mix of these higher priced products, but yet our cost of manufacturing not changing all that much, I mean, there are certainly some upward pressures around material costs and things, but we're not near the benefit that we're gonna see from all of these mixed benefits that you're describing. And so there is an absolute upward bias to our gross margin over the next several years. Have you ever talked about, or can you help us think about what gross margins could be in the long term, in the best case? Well, you know, we're in the kind of mid-60s now, you know, 65-66%. You know, getting into the mid-70s is not unreasonable, again, given some of those ASP dynamics we're talking about. Okay, great. Well, we're right on time, so I wanna keep us all on time. But thanks so much for your time, and thanks for your interest in Establishment. Thank you.