NASDAQ:ESTA Establishment Labs Q1 2024 Earnings Report $33.27 +0.25 (+0.76%) Closing price 05/7/2025 04:00 PM EasternExtended Trading$34.73 +1.46 (+4.38%) As of 07:43 AM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Polygon.io. Learn more. Earnings HistoryForecast Establishment Labs EPS ResultsActual EPS-$0.58Consensus EPS -$0.65Beat/MissBeat by +$0.07One Year Ago EPS-$0.48Establishment Labs Revenue ResultsActual Revenue$37.17 millionExpected Revenue$35.61 millionBeat/MissBeat by +$1.56 millionYoY Revenue Growth-20.10%Establishment Labs Announcement DetailsQuarterQ1 2024Date5/8/2024TimeAfter Market ClosesConference Call DateWednesday, May 8, 2024Conference Call Time4:30PM ETConference Call ResourcesConference Call AudioConference Call TranscriptPress Release (8-K)Quarterly Report (10-Q)Earnings HistoryCompany ProfilePowered by Establishment Labs Q1 2024 Earnings Call TranscriptProvided by QuartrMay 8, 2024 ShareLink copied to clipboard.There are 10 speakers on the call. Operator00:00:00Good afternoon. Welcome to Establishment Labs First Quarter 20 24 Earnings Call. At this time, all participants will be in a listen only mode. At the end of this call, we will open up the line for question and answer session and instructions will follow at that As a reminder, today's call is being recorded. I will now turn the call over to Raj Denhoy, Chief Financial Officer. Operator00:00:22Please go ahead. Speaker 100:00:23Thank you, operator, and thank you everyone for joining us. With me today is Wanda S. H. Chacon Kiras, our Chief Executive Officer. Following our prepared remarks, we'll take your questions. Speaker 100:00:32Before we begin, I would like to remind you that comments made by management during this call will include forward looking statements within the meaning of federal securities laws. These include statements on Establishment Labs' financial outlook and the company's plans and timing for product development and sales. These forward looking statements are based on management's current expectations and involve risks and uncertainties. For a discussion of the principal risk factors and uncertainties that may affect our performance or cause actual results to differ materially from these statements, I encourage you to review our most recent annual and quarterly reports on Form 10 ks and Form 10 Q as well as other SEC filings, which are available on our website at establishlapse.com. I'd also like to remind you that our comments may include certain non GAAP financial measures with respect to our performance, including but not limited to sales results, which can be stated on a constant currency basis or profitability of the company's business, which can be stated as EBITDA or adjusted EBITDA. Speaker 100:01:24Reconciliations to comparable GAAP financial measures for non GAAP measures, if available, may be found in today's press release, which is available on our website. Please also note that Establisher Labs received an investigational device exemption from the FDA for Motiva Implants and is undergoing a clinical trial to support regulatory approval in the United States. We continually seek to expand the geographies in which our products are regulatory approved. Please check with your local authority for product availability. The content of this conference call contains time sensitive information accurate only as of the date of this live broadcast, May 8, 2024. Speaker 100:01:57Except as required by law, Establisher Labs undertakes no obligation to revise or otherwise update any statement to reflect events or circumstances after the date Speaker 200:02:05of this call. With that, it is my pleasure to turn the call over to our CEO, Juan Jose. Thank you, Raj, and good afternoon, everyone. Revenue in the Q1 of 2024 totaled $37,200,000 Our markets continue to stabilize and we are seeing improving demand. All of our global regions showed sequential improvement in the Q1. Speaker 200:02:30We saw this in both our direct and distributor markets and we expect to see continued improvement throughout 2024. Our Q1 also showed the tangible results of cost reduction and efficiency improvement activities we undertook in the second half of last year. Adjusted EBITDA improved to a loss of less than $4,000,000 This was a notable improvement from the loss of $17,000,000 last quarter. We are off to a busy start in 2024. Over the past several months, we launched Motiva Implants in China in our Fluorat tissue expander in the United States. Speaker 200:03:07We are also making significant progress to our approval of Motiva Implants in the United States. This number of clinics offering me around world is growing and the feedback on this transformative breast technology continues to surpass even our own expectations. We are well We are well positioned for multi year growth while steadily improving our margin structure and achieving the necessary scale to reach cash flow profitability in 2020 5. Raj will provide more on our financial results and outlook in a moment, but first I want to highlight several recent events. Last week, we announced 2 important developments on our path to U. Speaker 200:03:47S. Approval. The 4 year data from our Motiva U. S. ID study was presented at the Aesthetic Meeting on May 2 by Doctor. Speaker 200:03:55Caroline Glixman, the Medical Director Speaker 300:03:59a Speaker 200:04:09have not changed for the past 2 years. At year 4, there continues to be only 2 patients with capsular contracture and only one patient with a rates are a confirmation of a new standard for breast implants and we expect plastic surgeons will adopt our products given their technological superiority and performance. While these are not comparative studies, it is worth noting that at 4 years, the FDA data from the 2 largest competitors Baker Grade 3 or 4 capsular contracture. In the Motiva study, it was 1 in 200 women. We also announced last week Jeff Earhart will lead our North American business. Speaker 200:05:03Jeff most recently ran the plastic and reconstruction division of Allergan Aesthetics and was responsible for the breast products portfolio. Jeff is a strong commercial leader with over 25 years of experience in this industry. I cannot imagine anyone better suited to introduce Motiva to the U. S. Market. Speaker 200:05:23Jeff is already building an experienced team with a successful track record in this industry, including Ann Pug, who will head our U. S. Sales team and Ben Newcutt, who is Director of surgeon community. This is truly an all star team. At the annual meeting of the Aesthetic Society in Vancouver this past weekend, establishment labs in Motiva were the talk of the conference. Speaker 200:05:50Plastic surgeons are overwhelmingly enthusiastic about our new hires and the launch of Motiva in the United States might be the most anticipated launch of an aesthetic product in decades. Surgeons and investor alike want to know when Motiva will be available in the United States and while the 2nd quarter inspection of our facilities is a critical point in the process, we will continue not to predict an exact timeline for both competitor and regulatory reasons. That said, the conversations with the FDA are highly constructive and we have high confidence that we will be on market in 2020 the U. S. Market. Speaker 200:06:34Flora has many important and novel features, including our patented SmoothSilk Surface technology as well as an RFID enabled non magnetic port and is labeled as MR conditional by the FDA. This is a distinct advantage to FLORA as all other commercially available breast tissue expanders include magnets. We had many surgeons come by our booth in Vancouver to learn about the advantages of FLORA in reconstruction and we expect adoption of this technology will continue throughout the course of 2024. We have completed the VAC process at a MiaFemtek is creating an entirely new minimally invasive category within breast aesthetics and the list of cities across Dhabi, Beirut and our hometown of San Jose. In total, we have 55 clinics signed up for a negotiation. Speaker 200:08:10Miek consumers are sharing their experiences on social media, highlighting the convenience and aesthetic outcomes of their breath harmonization journey confirming our conviction that word-of-mouth will ultimately be the biggest growth driver for new consumer demand in this new category in breast aesthetics. In China, the reception of our recent launch has been strong. Chinese plastic surgeons and consumers have a strong appreciation for Motiva as the latest in innovation, science and technology and there is a willingness to pay a premium for such offerings in this market. Our exclusive distribution partner is pursuing an aggressive of medical education and marketing events in Tier 1 and Tier 2 cities across China. The early results give us us leaders. Speaker 200:09:13I will now turn over the call to Raj. Speaker 100:09:17Thank you, Anoj. Total revenue for the Q1 was $37,200,000 a decline of 20% from the year ago period. Direct sales in the Q1 were approximately 39% of implant sales, while distributors made up the balance. From a regional perspective, sales in Europe, Middle East and Africa were approximately 55% of the global total, Asia Pacific 21% and Latin America 23%. Brazil, which is our largest market globally accounted for approximately 11% of total quarterly sales. Speaker 100:09:46Our gross profit for the Q1 was $24,400,000 or 65.6 percent of revenue compared to 30.1 0.1000000 dollars or 64.7 percent of revenue for the same period in 2023. Our gross profit in the Q1 reflected an increase in average selling prices year over year offset somewhat by higher overhead and labor costs. Changes in foreign exchange rates between the U. S. Dollar and the Costa Rican clone also continued to be S. Speaker 100:10:10Dollars, the continued strengthening of the clone has resulted in higher operating costs. SG and A expenses for the Q1 declined approximately $2,800,000 to $28,900,000 compared to $31,700,000 in the Q1 of 2023. SG and A expenses also declined approximately $8,000,000 from the $36,900,000 reported in the 4th quarter. R and D expenses for the Q1 declined approximately $2,200,000 from the same quarter a year ago to $4,300,000 and were down $1,500,000 sequentially. Total operating expenses for the Q1 were $33,200,000 a decrease of approximately $5,000,000 from the year ago and declined approximately $9,500,000 from the 4th quarter due primarily to cost reduction initiatives. Speaker 100:10:57The decrease in operating expenses in Q1 was primarily the result of the cost reduction initiatives we undertook in the second half of twenty twenty three and into 2024 as well as the timing of certain planned expenses this year. Net loss from operations for the Q1 was $8,800,000 compared to a net loss of $8,200,000 in the same period in 2023 $22,100,000 in the 4th quarter. Adjusted EBITDA was a loss of $3,700,000 in the quarter. This compared to a loss of $17,300,000 in the 4th quarter and a loss of $4,000,000 in the year ago period. Our cash position on March 31 was $73,000,000 dollars compared to $40,000,000 at the end of 2023. Speaker 100:11:37Excluding the proceeds from our January 50 underlying cash used in the Q1 was $16,800,000 As a reminder, we have 2 remaining tranches on our debt facility which totaled 50,000,000 dollars We can access the first $25,000,000 on US FDA approval of Motiva Implants and the second with the additional milestone of achieving 195,000,000 dollars in trailing 12 month sales. For 2024, our revenue guidance continues to exclude the contribution of Motiva Implants in the United States. Our guidance remains at $174,000,000 to $184,000,000 representing growth of 5% to 11%. We expect currency to have a minimal impact on our sales this year. We continue to expect gross margins in 2024 to be approximately 100 basis points higher than 2023 to a range of 65.5 percent to 66 percent. Speaker 100:12:28The pacing of operating expenses this year is going to be fluid given the timing of approval of Motiva Implants in the U. S. Our increasing confidence in approval this year has led us begin making some key hires and to begin limited activities to prepare for the launch. As such, we expect operating expenses will increase modestly from Q1 levels. We remain focused on managing operating expenses and cash use and excluding investments in the U. Speaker 100:12:51S, we are targeting positive adjusted EBITDA by the end of 20 24 and positive cash flow by the end of 2025. The timing of U. S. Commercialization will affect when we achieve these targets. However, the additional capital which becomes available to will more than fully support our current launch plans. Speaker 100:13:08Also given the strong ASPs in the United States, our North America business achieves profitability very quickly. We are very focused on ensuring that the cash we currently have on hand and which is accessible to us under our credit facility will properly fund our business to profitability without the need for additional capital. I'll now turn the Speaker 200:13:25call back to Juan Jose. Thank you, Raj. 2024 is off to a very good start. We are seeing steady recovery in our markets and our differentiated technologies continue to support our progress globally. The work we did at the end of last year in restructuring and refocusing organization is allowing us to invest in growth while we progress towards profitability. Speaker 200:13:48Our goals of being adjusted EBITDA positive by the end of the year and cash flow positive next year excluding investments in the U. S. Remain firmly intact and management team. Early this year, we entered China, the 2nd largest market for our technologies globally. Flora is pushing us deeper into breast reconstruction while establishing a new standard of care. Speaker 200:14:15Our most recent family of implants, Ergonomix 2 is supporting exciting new program offerings like Joy and of course, MiaFemtek, which is creating an entirely new category aesthetics and which will lead to real market expansion over time. The rest of the year will be even more exciting. The pending launch of Motiva in the United States is a culmination of years of work at Establishment Labs and we cannot wait to introduce our story to women and surgeons the largest market in the world. As a company focused on women's health, we are building on a solid foundation and have a clear path to further establish ourselves as the leader globally in breast aesthetics and reconstruction. I will now turn the call over to the operator for your questions. Operator00:15:02Thank Our first question is from Harrison Parsons with Stephens Inc. Please proceed. Speaker 400:15:30Great. Hi. This is Harrison on for George. Good afternoon and thanks for taking our questions. I wanted to start with your underlying assumptions and your reiterated guidance. Speaker 400:15:45I know you in the press release spoke to market demand stabilizing. I just wanted to dig in on kind of what you're assuming from a macro perspective in that guidance? Speaker 100:16:02Sure. Hi, Harrison. As you saw in this quarter, we saw a nice sequential improvement over where we were in the Q4. And as we move into the Q2, we expect to see a similar level of improvement in demand. Generally, we're seeing distribute orders come back. Speaker 100:16:16The direct markets are doing a bit better. And so generally, things are stabilizing. And so as we progress through the year, we expect that trend is going to continue. Yes, so overall, we feel pretty good about where we are and how things are shaping up and things are definitely getting better out there. Speaker 400:16:33Great. Yes. And then I know you just touched on it, but wanted to dig in a little bit on the what you're hearing from your international distributors. Where do you think their inventory levels sit today? I know obviously that's out of your control, but what are your expectations for those inventory levels going throughout the year? Speaker 400:16:55And is that going to be a headwind or a tailwind for the remainder? Thanks for the questions. Speaker 200:17:02Yes. What we hear from our distribution partners around the world is that demand is improving, and that's very much in all regions of the world. I think Latin America is probably a lagger there. We don't expect demand there to come back as quickly as in the other regions. And as a result, of course, they're running through their inventories and that's why they're ordering again. Speaker 200:17:24If you saw like the pattern of distribution demand this quarter, it was back to what we consider more normalized levels at around the sixty-forty percentage. Speaker 400:17:36Great. That sounds good. Thanks for taking the questions. Operator00:17:41Our next question is from Alan Geng with JP Morgan. Please proceed. Speaker 200:17:49Thanks. So I just kind Speaker 500:17:50of want to dive deeper into direct markets, right? You talked about how it seems like trends are getting better. So when we think about the fact that you reiterated the guidance off of a quarter that at least relative to Street expectations look a little bit better, how should we think about the kind of assumptions that get you to the bottom or higher end of that range? Speaker 100:18:18Yes. I think, Alan, we're only really through 1 quarter in the year, right? And as we commented to the last question, things are feeling better, right? You can see it in the trends, the sequential improvement this quarter, what we're talking about is similar sequential improvement into the 2nd quarter. So in terms of the range, at this point in the year, we feel so early to be adjusting that. Speaker 100:18:37But overall, we're feeling pretty good about where we are and really trending towards the upper end of that range this year. Speaker 500:18:45Got it. And then I guess just in anticipation of a U. S. Launch later this year, can you talk to kind of the underlying health of the U. S. Speaker 500:18:53Market? I know we're still kind of waiting for the societies to put out the volume data from 2023, but we saw that really was bouncing around quite a bit during and in the wake of the pandemic. So can you just talk to the underlying health of the U. S. And how that positions you for a launch in the back half of the year? Speaker 500:19:12Thank you. Speaker 200:19:15Yes. Thanks, Alan. So we were just at the American Society of Aesthetic Plastic Surgery meeting in Vancouver. And we had the opportunity to talk about this with many plastic surgeons from all over the U. S. Speaker 200:19:27And I think they did see a significant dip down in the level of procedures last year and what they have said is that they see an improvement taking place. It is of course not close to the like hype that they saw during the 2nd part of the pandemic where they really saw above normal demand nearly all over the United States, but it is starting to normalize according to what we heard from them over last week. Operator00:20:09Our next question is from Marie Thibault with BTIG. Please proceed. Speaker 600:20:16Hi, thanks so much for taking the questions and congrats on a very nice start to the year. I wanted to ask here with the U. S. Approval expected this year, hoping we can get a little bit more detail on how you're thinking about the sales force build out with Jeff in place, would love to hear a little bit about the go to market strategy. I know we'll have to wait to see some of the bigger spending and investments, but would really love to just hear about a potential range for how many sales reps and that selling strategy that you're going to be targeting? Speaker 200:20:52Yes. Thanks, Marie. Well, we have been investing in the U. S. For quite some time. Speaker 200:20:57We have been building the necessary foundation for the commercial organization, especially the back office commercial ops. And we are also leveraging a lot of the infrastructure we have built in areas like HR, legal, finance and regulatory from our global team. So that's been part of what we've done already and we've considered already why we're invoicing and shipping Fluoratissue expanders to U. S. Now with having Jeff on board, I think it signals our conviction that we need to get prepared for the U. Speaker 200:21:33S. Launch. And not only did we add Jeff, we also add Ann Pug, who will head our U. S. Sales team and Ben Newcutt, who's like basically Director of Surgeon Engagement and Business Development. Speaker 200:21:46Their combined experience in the U. S. Market is, I would say, second to none. And with that, what we are building is this strong foundation for launch readiness. We are going to be very mindful of how we grow our sales force, but I think we're getting to the point where like that foundation, that commercial foundation is already there. Speaker 200:22:07And we've added a couple of sales reps already for the tissue expander and we continue to add more in the next few months as we feel that we are getting closer and closer to the launch. For competitive reasons, I'm not going to share too much of the details, but definitely we are at a point where we are going to start building up that sales force. Speaker 600:22:31Okay. That's great to hear. Thanks for that detail. And then wanted to ask my next question here on China. Any ability to offer more details on the amount of revenue recognized in China this quarter or how we should think about that over the year? Speaker 600:22:46Is it going sort of according to expectations? And where can you eventually see market share going to in China? And thanks for taking the questions. Speaker 100:22:56Yes, I can start with that and JJ can talk a little bit about the market share. I think as we've talked about China, right, as we move through 2023, what we had expected in 2023, we pushed into 2024. Can tell you that we are tracking to that. China is developing as we expected. We're seeing demand. Speaker 100:23:13It is building. And so I can tell you that we're on track in terms of our plans in China. In terms of eventual market share and the size of that market, JJ, if you want to maybe take that? Speaker 200:23:24Yes, of course. So it's super early on. It's just been a few months since we launched in China. We're at this point basically hitting Tier 1 and Tier 2 cities with our events, medical education. So it's early. Speaker 200:23:39But we have a very good experience in the blueprint that we have used in other countries in Asia and surrounding countries where you have a strong Chinese population like Singapore, Taiwan, Hong Kong. And what we see is that they quickly realize that this is a superior technology. There's a willingness to pay. So we do expect our market share in the next few years to match some of the same leadership that we've seen in the surrounding countries where we have between 40% 70% market share. In China, right now, one of our competitors has 70% or more market share. Speaker 200:24:23So we have a very clear plan on how to go about that. And definitely, as we build on this initial launch activities, I think we'll be able to talk with more detail about how we are doing Operator00:24:44Our next question is from Anthony Petrone with Mizuho Securities. Please proceed. Speaker 300:24:51Thank you and good afternoon everyone. So maybe one just on the process of the FDA inspection and how long that actually takes and what the range of turnaround time is? So just trying to get an idea of timing and how the actual process plays out? And then on China specifically, a follow-up question there would be just on the stimulus package that was announced in March. There are some other healthcare consumer related companies that do see this as a potential catalyst into the second half of the year. Speaker 300:25:23So do you think China's stimulus could actually lead to upside as we get into the second half? Thanks again. Speaker 200:25:34Yes. Well, thank you, Anthony. On the first one, last time we were able to speak openly about it. What we talked about is that the FDA had given us a date for Q2. Can tell you now that pre approval inspection of our manufacturing facility in Costa Rica is scheduled to take place in less than 30 days. Speaker 200:25:58And our team is super well prepared and looking forward for it. In parallel, we have been making good progress with labeling and post market approval studies. And these are the last significant steps before the FDA approval. So we are getting very close to final stages on this and we want just to be very mindful of not disrupting that process. And on China and the stimulus package, yes, we're very well aware of it and we think it's a good development. Speaker 200:26:25It will take time to get through, so that it can really impact consumer demand. But we do see it as a positive. Remember, the lowest of the Chinese market in breast aesthetics happening actually in 2022. And since then, it's been bouncing back. Our expectation that is was that it was going to be back to 2019 levels by 2025, but maybe that stimulus package will be able to get us there faster. Speaker 300:26:56Thank you again. Operator00:27:00Our next question is from Matt Taylor with Jefferies. Please proceed. Speaker 700:27:07Great. Thanks for taking the question. Maybe I'll ask one on the EMEA commentary that you gave. I mean, it's encouraging to see that you're signing up all these centers. Was wondering if you could talk about how material the revenue contribution is going to be this year? Speaker 700:27:22And then maybe you could frame the centers that you're adding for Mia FEMTECH in terms of your overall centers, what percentage is that today and what do you think will be at maturity? Speaker 200:27:37Yes, I think with that one, Matt, at this point what I tell you is that what we are trying to do at the qualitative level, which is create the network of clinics and within those clinics start bringing in all of our marketing assets, the practice development, all the things that we provide so that you can have the new category really coming to light in there. I can see that some clinics who started in Europe for instance in September, October of last year have started to get to the numbers where we would like to see them in terms of number of procedures per month. We still have work to do to see those numbers in every single one of the centers, but that's part of the entire process of building a new category. So we're not in a rush. However, I think that having signed up 55 clinics already, 33 who are active right now, of those of course, the ones that are, that have started in the fall of last year are the ones of course that are getting more cases at this point. Speaker 200:28:48In addition, we have 37 new clinics under negotiation. We have this aspirational goal of getting to 100 clinics by the end of this year. And I think after that, you would what our expectations are is that in every Tier 1 city, there will be a few of these clinics. In every Tier 2 city, there will be a couple of those. And in some Tier 3 cities, you'll see 1. Speaker 200:29:09And when you start putting those numbers in and you start getting to the levels at which we see the initial clinics, I think we get an understanding of how quickly this can ramp up. But in 2024, it is mostly qualitative. But you will start seeing more revenue coming out of EMEA. We are very dedicated to the qualitative part. It is not time yet to break out EMEA revenue, but I think when it becomes material, we will be the first ones willing to do that. Speaker 700:29:42Great. Thanks, JJ. Maybe just one follow-up on China. It seems like everything is going well there. I just wanted to confirm more specifically, you talked about just the $10,000,000 in stocking revenue kind of spread out through the first half of the year and that was it for the guidance. Speaker 700:29:58Is that still your assumption and are you seeing any reordering yet? Speaker 100:30:03It's still early. Juan, as I mentioned, I mean, we've been there just a couple of months now. We launched in January. So it is tracking as we expected to the numbers you described. We'll see how the reordering starts to build in the back half of the year, but so far things are tracking. Speaker 700:30:20Okay. All right. Thank you. Thanks, Raj. Operator00:30:24Our next question is from Joanne Wuensch with Citibank. Please proceed. Speaker 800:30:31Thank you for taking the question and very nice quarter. I appreciate the commentary on the guidance that it is early in the year, but you did exceed consensus. And I'm curious how you think about the next couple of quarters. I just want to make sure that the second, third and fourth quarters are sort of set up appropriately. Speaker 100:30:51Yes, I think Joanne as we mentioned, you look at the sequential increase in the Q1 over last quarter in about $6,000,000 I think a similar sequential increase into the Q2 is the right way to think about it. The back half of the year, again, we'll see likely a small sequential increase in the 3rd, it tends to be the weakest of the quarters for us as the year unfolds, but you have the dynamic of the recovery in the markets. So we'll see growth into the Q3 as well. So generally it gets back to the commentary made about this recovery that we're seeing in the markets, the distributor orders improving. So I think that's probably a good way to think about it over the balance of the year. Speaker 800:31:34Thank you. And then is there anything that you could share regarding your go to market strategy in the United States? I'm thinking pricing, number of sales people you would need or anything else that you're comfortable sharing at this stage of the process? Thank you. Speaker 200:31:49Yes, unfortunately Joanne it's for competitive reasons this is exactly the type of things that we cannot give out. We have a very clear understanding of how we want to price in the United States. We are coming in with 2 products, Motiva SmoothSilk Round and Motiva SmoothSilk Ergonomics. Those are some of our best selling products in our international market and have been so for many years. And we will make the necessary investments to make sure that we provide the accounts as we move into different quarters after the launch, the necessary service that they deserve. Speaker 200:32:27So at this point, that's all I can tell you. Speaker 800:32:30I appreciate that. Thank you. Operator00:32:34Our final question is from Josh Jennings with TD Cowen. Please proceed. Speaker 900:32:41Hi, good afternoon. Thanks a lot. I was hoping to follow-up on Mia first. And just in the past, Juan Jose, your team has talked about your MIA partner clinics becoming $1,000,000 revenue generators for establishment labs? I mean, it sounds like these early launch trends are positive, but to get to that $1,000,000 per account, you had some relatively conservative assumptions. Speaker 900:33:07I just wanted to sanity check, make sure that that's your team is still optimistic that that revenue run rate per partner clinic is still in play potentially? Speaker 200:33:20Yes. Thank you, Josh. In the direct market, a MIA clinic that is doing an average for a year 24 cases per month will eventually lead to approximately $1,000,000 that is recognized by Establishment Labs. We think that number is achievable. Like I said, a couple of the clinics that began last fall are starting to trend to those numbers. Speaker 200:33:47So that's what gives us a conviction that those numbers can be achieved. And our job now is to expand the network of clinics to cities, for instance, across our direct markets in Europe. Some of the distributor markets have already kicked in. You can see in the social media handle of MiaFemtek, a lot of the work that has been done, for instance, to launch in several cities across the Middle East. So all of that tells you that we are building something special. Speaker 200:34:17And when you think about the current market for breast aesthetics, it's a market that is growing at low single digits at best. And what Mia brings is this new shiny object and what we see is that those numbers are not something that we see as unachievable and what we would like to see is that clinics in the 1st or second year depending on them being Tier 1 or Tier 2 city clinics can get there. Speaker 900:34:51Great. And appreciate some of the color on the U. S. FluorA launch. I was hoping to just check-in on the state of affairs of the Recon franchise internationally, both on the tissue expander side and on the implant side. Speaker 900:35:06Any updates you can provide just on traction there in Europe and other regions? Thanks for taking the questions. Speaker 200:35:16Yes. On that one, Josh, again, like I think what we've said many times is that breast reconstruction is slower because you're not really convincing just a plastic surgeon, you have to convince the plastic surgeons of a reconstructive department in a hospital and then wait for a tender to take place. So that's why although we see great feedback from the hospitals who have adopted, Flora and who have started to use with Flora, our breast implants, it's still not going at the same speed of adoption that we normally see when we go into a market on purely aesthetics. However, over time it will build and I think it's a big demonstration of our technology and our women's health credentials in this industry. Speaker 900:36:11Appreciate that. Thanks. Operator00:36:15That is all the time we have for questions today. I will now turn the call back over to Juan Jose for closing remarks. Speaker 200:36:23Thank you for joining us on today's call. We look forward to providing our next quarterly update in August, and we wish everyone continued good health and happiness. Operator00:36:34Thank you. This concludes today's conference. You may disconnect your lines at this time and thank you for your participation.Read morePowered by Conference Call Audio Live Call not available Earnings Conference CallEstablishment Labs Q1 202400:00 / 00:00Speed:1x1.25x1.5x2x Earnings DocumentsPress Release(8-K)Quarterly report(10-Q) Establishment Labs Earnings HeadlinesEstablishment Labs Appoints Peter Caldini as Chief Executive OfficerMay 7 at 6:14 PM | finance.yahoo.comEstablishment Labs Reports First Quarter 2025 Financial ResultsMay 7 at 6:14 PM | finance.yahoo.comTrump to redistribute trillions of dollars Seeing how the media and other analysts are covering Trump’s actions – it’s laughable. At least it would be laughable if it wasn’t putting so many Americans’ financial futures at severe risk… That’s why, with the 100-day mark of Trump’s second term just days away, it’s time to shine a light on what’s really going on, because if you move your money out of the wrong places and into the right ones before it’s too late… …you could be one of the few who profits from this imminent trillion-dollar reset.May 8, 2025 | Porter & Company (Ad)Establishment Labs to Announce First Quarter 2025 Financial Results on May 7April 24, 2025 | finance.yahoo.comEstablishment Labs Holdings: Impressive Growth, Several CaveatsApril 21, 2025 | seekingalpha.comNeedham Initiates Coverage of Establishment Labs Holdings (ESTA) with Hold RecommendationApril 14, 2025 | msn.comSee More Establishment Labs Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like Establishment Labs? Sign up for Earnings360's daily newsletter to receive timely earnings updates on Establishment Labs and other key companies, straight to your email. Email Address About Establishment LabsEstablishment Labs (NASDAQ:ESTA), a medical technology company, manufactures and markets medical devices for aesthetic and reconstructive plastic surgery. The company primarily offers silicone gel-filled breast implants under the Motiva Implants brand. It also provides Motiva Ergonomix and Motiva Ergonomix2 gravity sensitive round soft silicone-gel-filled breast implants; and Motiva Flora Tissue Expander, a breast tissue expander. The company sells its products to physicians, hospitals, and clinics through distributors and direct sales force in Europe, the Middle East, Latin America, and Asia. Establishment Labs Holdings Inc. was incorporated in 2004 and is headquartered in Alajuela, Costa Rica.View Establishment Labs ProfileRead more More Earnings Resources from MarketBeat Earnings Tools Today's Earnings Tomorrow's Earnings Next Week's Earnings Upcoming Earnings Calls Earnings Newsletter Earnings Call Transcripts Earnings Beats & Misses Corporate Guidance Earnings Screener Earnings By Country U.S. Earnings Reports Canadian Earnings Reports U.K. Earnings Reports Latest Articles Disney Stock Jumps on Earnings—Is the Magic Sustainable?Archer Stock Eyes Q1 Earnings After UAE UpdatesFord Motor Stock Rises After Earnings, But Momentum May Not Last Broadcom Stock Gets a Lift on Hyperscaler Earnings & CapEx BoostPalantir Stock Drops Despite Stellar Earnings: What's Next?Is Eli Lilly a Buy After Weak Earnings and CVS-Novo Partnership?Is Reddit Stock a Buy, Sell, or Hold After Earnings Release? 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There are 10 speakers on the call. Operator00:00:00Good afternoon. Welcome to Establishment Labs First Quarter 20 24 Earnings Call. At this time, all participants will be in a listen only mode. At the end of this call, we will open up the line for question and answer session and instructions will follow at that As a reminder, today's call is being recorded. I will now turn the call over to Raj Denhoy, Chief Financial Officer. Operator00:00:22Please go ahead. Speaker 100:00:23Thank you, operator, and thank you everyone for joining us. With me today is Wanda S. H. Chacon Kiras, our Chief Executive Officer. Following our prepared remarks, we'll take your questions. Speaker 100:00:32Before we begin, I would like to remind you that comments made by management during this call will include forward looking statements within the meaning of federal securities laws. These include statements on Establishment Labs' financial outlook and the company's plans and timing for product development and sales. These forward looking statements are based on management's current expectations and involve risks and uncertainties. For a discussion of the principal risk factors and uncertainties that may affect our performance or cause actual results to differ materially from these statements, I encourage you to review our most recent annual and quarterly reports on Form 10 ks and Form 10 Q as well as other SEC filings, which are available on our website at establishlapse.com. I'd also like to remind you that our comments may include certain non GAAP financial measures with respect to our performance, including but not limited to sales results, which can be stated on a constant currency basis or profitability of the company's business, which can be stated as EBITDA or adjusted EBITDA. Speaker 100:01:24Reconciliations to comparable GAAP financial measures for non GAAP measures, if available, may be found in today's press release, which is available on our website. Please also note that Establisher Labs received an investigational device exemption from the FDA for Motiva Implants and is undergoing a clinical trial to support regulatory approval in the United States. We continually seek to expand the geographies in which our products are regulatory approved. Please check with your local authority for product availability. The content of this conference call contains time sensitive information accurate only as of the date of this live broadcast, May 8, 2024. Speaker 100:01:57Except as required by law, Establisher Labs undertakes no obligation to revise or otherwise update any statement to reflect events or circumstances after the date Speaker 200:02:05of this call. With that, it is my pleasure to turn the call over to our CEO, Juan Jose. Thank you, Raj, and good afternoon, everyone. Revenue in the Q1 of 2024 totaled $37,200,000 Our markets continue to stabilize and we are seeing improving demand. All of our global regions showed sequential improvement in the Q1. Speaker 200:02:30We saw this in both our direct and distributor markets and we expect to see continued improvement throughout 2024. Our Q1 also showed the tangible results of cost reduction and efficiency improvement activities we undertook in the second half of last year. Adjusted EBITDA improved to a loss of less than $4,000,000 This was a notable improvement from the loss of $17,000,000 last quarter. We are off to a busy start in 2024. Over the past several months, we launched Motiva Implants in China in our Fluorat tissue expander in the United States. Speaker 200:03:07We are also making significant progress to our approval of Motiva Implants in the United States. This number of clinics offering me around world is growing and the feedback on this transformative breast technology continues to surpass even our own expectations. We are well We are well positioned for multi year growth while steadily improving our margin structure and achieving the necessary scale to reach cash flow profitability in 2020 5. Raj will provide more on our financial results and outlook in a moment, but first I want to highlight several recent events. Last week, we announced 2 important developments on our path to U. Speaker 200:03:47S. Approval. The 4 year data from our Motiva U. S. ID study was presented at the Aesthetic Meeting on May 2 by Doctor. Speaker 200:03:55Caroline Glixman, the Medical Director Speaker 300:03:59a Speaker 200:04:09have not changed for the past 2 years. At year 4, there continues to be only 2 patients with capsular contracture and only one patient with a rates are a confirmation of a new standard for breast implants and we expect plastic surgeons will adopt our products given their technological superiority and performance. While these are not comparative studies, it is worth noting that at 4 years, the FDA data from the 2 largest competitors Baker Grade 3 or 4 capsular contracture. In the Motiva study, it was 1 in 200 women. We also announced last week Jeff Earhart will lead our North American business. Speaker 200:05:03Jeff most recently ran the plastic and reconstruction division of Allergan Aesthetics and was responsible for the breast products portfolio. Jeff is a strong commercial leader with over 25 years of experience in this industry. I cannot imagine anyone better suited to introduce Motiva to the U. S. Market. Speaker 200:05:23Jeff is already building an experienced team with a successful track record in this industry, including Ann Pug, who will head our U. S. Sales team and Ben Newcutt, who is Director of surgeon community. This is truly an all star team. At the annual meeting of the Aesthetic Society in Vancouver this past weekend, establishment labs in Motiva were the talk of the conference. Speaker 200:05:50Plastic surgeons are overwhelmingly enthusiastic about our new hires and the launch of Motiva in the United States might be the most anticipated launch of an aesthetic product in decades. Surgeons and investor alike want to know when Motiva will be available in the United States and while the 2nd quarter inspection of our facilities is a critical point in the process, we will continue not to predict an exact timeline for both competitor and regulatory reasons. That said, the conversations with the FDA are highly constructive and we have high confidence that we will be on market in 2020 the U. S. Market. Speaker 200:06:34Flora has many important and novel features, including our patented SmoothSilk Surface technology as well as an RFID enabled non magnetic port and is labeled as MR conditional by the FDA. This is a distinct advantage to FLORA as all other commercially available breast tissue expanders include magnets. We had many surgeons come by our booth in Vancouver to learn about the advantages of FLORA in reconstruction and we expect adoption of this technology will continue throughout the course of 2024. We have completed the VAC process at a MiaFemtek is creating an entirely new minimally invasive category within breast aesthetics and the list of cities across Dhabi, Beirut and our hometown of San Jose. In total, we have 55 clinics signed up for a negotiation. Speaker 200:08:10Miek consumers are sharing their experiences on social media, highlighting the convenience and aesthetic outcomes of their breath harmonization journey confirming our conviction that word-of-mouth will ultimately be the biggest growth driver for new consumer demand in this new category in breast aesthetics. In China, the reception of our recent launch has been strong. Chinese plastic surgeons and consumers have a strong appreciation for Motiva as the latest in innovation, science and technology and there is a willingness to pay a premium for such offerings in this market. Our exclusive distribution partner is pursuing an aggressive of medical education and marketing events in Tier 1 and Tier 2 cities across China. The early results give us us leaders. Speaker 200:09:13I will now turn over the call to Raj. Speaker 100:09:17Thank you, Anoj. Total revenue for the Q1 was $37,200,000 a decline of 20% from the year ago period. Direct sales in the Q1 were approximately 39% of implant sales, while distributors made up the balance. From a regional perspective, sales in Europe, Middle East and Africa were approximately 55% of the global total, Asia Pacific 21% and Latin America 23%. Brazil, which is our largest market globally accounted for approximately 11% of total quarterly sales. Speaker 100:09:46Our gross profit for the Q1 was $24,400,000 or 65.6 percent of revenue compared to 30.1 0.1000000 dollars or 64.7 percent of revenue for the same period in 2023. Our gross profit in the Q1 reflected an increase in average selling prices year over year offset somewhat by higher overhead and labor costs. Changes in foreign exchange rates between the U. S. Dollar and the Costa Rican clone also continued to be S. Speaker 100:10:10Dollars, the continued strengthening of the clone has resulted in higher operating costs. SG and A expenses for the Q1 declined approximately $2,800,000 to $28,900,000 compared to $31,700,000 in the Q1 of 2023. SG and A expenses also declined approximately $8,000,000 from the $36,900,000 reported in the 4th quarter. R and D expenses for the Q1 declined approximately $2,200,000 from the same quarter a year ago to $4,300,000 and were down $1,500,000 sequentially. Total operating expenses for the Q1 were $33,200,000 a decrease of approximately $5,000,000 from the year ago and declined approximately $9,500,000 from the 4th quarter due primarily to cost reduction initiatives. Speaker 100:10:57The decrease in operating expenses in Q1 was primarily the result of the cost reduction initiatives we undertook in the second half of twenty twenty three and into 2024 as well as the timing of certain planned expenses this year. Net loss from operations for the Q1 was $8,800,000 compared to a net loss of $8,200,000 in the same period in 2023 $22,100,000 in the 4th quarter. Adjusted EBITDA was a loss of $3,700,000 in the quarter. This compared to a loss of $17,300,000 in the 4th quarter and a loss of $4,000,000 in the year ago period. Our cash position on March 31 was $73,000,000 dollars compared to $40,000,000 at the end of 2023. Speaker 100:11:37Excluding the proceeds from our January 50 underlying cash used in the Q1 was $16,800,000 As a reminder, we have 2 remaining tranches on our debt facility which totaled 50,000,000 dollars We can access the first $25,000,000 on US FDA approval of Motiva Implants and the second with the additional milestone of achieving 195,000,000 dollars in trailing 12 month sales. For 2024, our revenue guidance continues to exclude the contribution of Motiva Implants in the United States. Our guidance remains at $174,000,000 to $184,000,000 representing growth of 5% to 11%. We expect currency to have a minimal impact on our sales this year. We continue to expect gross margins in 2024 to be approximately 100 basis points higher than 2023 to a range of 65.5 percent to 66 percent. Speaker 100:12:28The pacing of operating expenses this year is going to be fluid given the timing of approval of Motiva Implants in the U. S. Our increasing confidence in approval this year has led us begin making some key hires and to begin limited activities to prepare for the launch. As such, we expect operating expenses will increase modestly from Q1 levels. We remain focused on managing operating expenses and cash use and excluding investments in the U. Speaker 100:12:51S, we are targeting positive adjusted EBITDA by the end of 20 24 and positive cash flow by the end of 2025. The timing of U. S. Commercialization will affect when we achieve these targets. However, the additional capital which becomes available to will more than fully support our current launch plans. Speaker 100:13:08Also given the strong ASPs in the United States, our North America business achieves profitability very quickly. We are very focused on ensuring that the cash we currently have on hand and which is accessible to us under our credit facility will properly fund our business to profitability without the need for additional capital. I'll now turn the Speaker 200:13:25call back to Juan Jose. Thank you, Raj. 2024 is off to a very good start. We are seeing steady recovery in our markets and our differentiated technologies continue to support our progress globally. The work we did at the end of last year in restructuring and refocusing organization is allowing us to invest in growth while we progress towards profitability. Speaker 200:13:48Our goals of being adjusted EBITDA positive by the end of the year and cash flow positive next year excluding investments in the U. S. Remain firmly intact and management team. Early this year, we entered China, the 2nd largest market for our technologies globally. Flora is pushing us deeper into breast reconstruction while establishing a new standard of care. Speaker 200:14:15Our most recent family of implants, Ergonomix 2 is supporting exciting new program offerings like Joy and of course, MiaFemtek, which is creating an entirely new category aesthetics and which will lead to real market expansion over time. The rest of the year will be even more exciting. The pending launch of Motiva in the United States is a culmination of years of work at Establishment Labs and we cannot wait to introduce our story to women and surgeons the largest market in the world. As a company focused on women's health, we are building on a solid foundation and have a clear path to further establish ourselves as the leader globally in breast aesthetics and reconstruction. I will now turn the call over to the operator for your questions. Operator00:15:02Thank Our first question is from Harrison Parsons with Stephens Inc. Please proceed. Speaker 400:15:30Great. Hi. This is Harrison on for George. Good afternoon and thanks for taking our questions. I wanted to start with your underlying assumptions and your reiterated guidance. Speaker 400:15:45I know you in the press release spoke to market demand stabilizing. I just wanted to dig in on kind of what you're assuming from a macro perspective in that guidance? Speaker 100:16:02Sure. Hi, Harrison. As you saw in this quarter, we saw a nice sequential improvement over where we were in the Q4. And as we move into the Q2, we expect to see a similar level of improvement in demand. Generally, we're seeing distribute orders come back. Speaker 100:16:16The direct markets are doing a bit better. And so generally, things are stabilizing. And so as we progress through the year, we expect that trend is going to continue. Yes, so overall, we feel pretty good about where we are and how things are shaping up and things are definitely getting better out there. Speaker 400:16:33Great. Yes. And then I know you just touched on it, but wanted to dig in a little bit on the what you're hearing from your international distributors. Where do you think their inventory levels sit today? I know obviously that's out of your control, but what are your expectations for those inventory levels going throughout the year? Speaker 400:16:55And is that going to be a headwind or a tailwind for the remainder? Thanks for the questions. Speaker 200:17:02Yes. What we hear from our distribution partners around the world is that demand is improving, and that's very much in all regions of the world. I think Latin America is probably a lagger there. We don't expect demand there to come back as quickly as in the other regions. And as a result, of course, they're running through their inventories and that's why they're ordering again. Speaker 200:17:24If you saw like the pattern of distribution demand this quarter, it was back to what we consider more normalized levels at around the sixty-forty percentage. Speaker 400:17:36Great. That sounds good. Thanks for taking the questions. Operator00:17:41Our next question is from Alan Geng with JP Morgan. Please proceed. Speaker 200:17:49Thanks. So I just kind Speaker 500:17:50of want to dive deeper into direct markets, right? You talked about how it seems like trends are getting better. So when we think about the fact that you reiterated the guidance off of a quarter that at least relative to Street expectations look a little bit better, how should we think about the kind of assumptions that get you to the bottom or higher end of that range? Speaker 100:18:18Yes. I think, Alan, we're only really through 1 quarter in the year, right? And as we commented to the last question, things are feeling better, right? You can see it in the trends, the sequential improvement this quarter, what we're talking about is similar sequential improvement into the 2nd quarter. So in terms of the range, at this point in the year, we feel so early to be adjusting that. Speaker 100:18:37But overall, we're feeling pretty good about where we are and really trending towards the upper end of that range this year. Speaker 500:18:45Got it. And then I guess just in anticipation of a U. S. Launch later this year, can you talk to kind of the underlying health of the U. S. Speaker 500:18:53Market? I know we're still kind of waiting for the societies to put out the volume data from 2023, but we saw that really was bouncing around quite a bit during and in the wake of the pandemic. So can you just talk to the underlying health of the U. S. And how that positions you for a launch in the back half of the year? Speaker 500:19:12Thank you. Speaker 200:19:15Yes. Thanks, Alan. So we were just at the American Society of Aesthetic Plastic Surgery meeting in Vancouver. And we had the opportunity to talk about this with many plastic surgeons from all over the U. S. Speaker 200:19:27And I think they did see a significant dip down in the level of procedures last year and what they have said is that they see an improvement taking place. It is of course not close to the like hype that they saw during the 2nd part of the pandemic where they really saw above normal demand nearly all over the United States, but it is starting to normalize according to what we heard from them over last week. Operator00:20:09Our next question is from Marie Thibault with BTIG. Please proceed. Speaker 600:20:16Hi, thanks so much for taking the questions and congrats on a very nice start to the year. I wanted to ask here with the U. S. Approval expected this year, hoping we can get a little bit more detail on how you're thinking about the sales force build out with Jeff in place, would love to hear a little bit about the go to market strategy. I know we'll have to wait to see some of the bigger spending and investments, but would really love to just hear about a potential range for how many sales reps and that selling strategy that you're going to be targeting? Speaker 200:20:52Yes. Thanks, Marie. Well, we have been investing in the U. S. For quite some time. Speaker 200:20:57We have been building the necessary foundation for the commercial organization, especially the back office commercial ops. And we are also leveraging a lot of the infrastructure we have built in areas like HR, legal, finance and regulatory from our global team. So that's been part of what we've done already and we've considered already why we're invoicing and shipping Fluoratissue expanders to U. S. Now with having Jeff on board, I think it signals our conviction that we need to get prepared for the U. Speaker 200:21:33S. Launch. And not only did we add Jeff, we also add Ann Pug, who will head our U. S. Sales team and Ben Newcutt, who's like basically Director of Surgeon Engagement and Business Development. Speaker 200:21:46Their combined experience in the U. S. Market is, I would say, second to none. And with that, what we are building is this strong foundation for launch readiness. We are going to be very mindful of how we grow our sales force, but I think we're getting to the point where like that foundation, that commercial foundation is already there. Speaker 200:22:07And we've added a couple of sales reps already for the tissue expander and we continue to add more in the next few months as we feel that we are getting closer and closer to the launch. For competitive reasons, I'm not going to share too much of the details, but definitely we are at a point where we are going to start building up that sales force. Speaker 600:22:31Okay. That's great to hear. Thanks for that detail. And then wanted to ask my next question here on China. Any ability to offer more details on the amount of revenue recognized in China this quarter or how we should think about that over the year? Speaker 600:22:46Is it going sort of according to expectations? And where can you eventually see market share going to in China? And thanks for taking the questions. Speaker 100:22:56Yes, I can start with that and JJ can talk a little bit about the market share. I think as we've talked about China, right, as we move through 2023, what we had expected in 2023, we pushed into 2024. Can tell you that we are tracking to that. China is developing as we expected. We're seeing demand. Speaker 100:23:13It is building. And so I can tell you that we're on track in terms of our plans in China. In terms of eventual market share and the size of that market, JJ, if you want to maybe take that? Speaker 200:23:24Yes, of course. So it's super early on. It's just been a few months since we launched in China. We're at this point basically hitting Tier 1 and Tier 2 cities with our events, medical education. So it's early. Speaker 200:23:39But we have a very good experience in the blueprint that we have used in other countries in Asia and surrounding countries where you have a strong Chinese population like Singapore, Taiwan, Hong Kong. And what we see is that they quickly realize that this is a superior technology. There's a willingness to pay. So we do expect our market share in the next few years to match some of the same leadership that we've seen in the surrounding countries where we have between 40% 70% market share. In China, right now, one of our competitors has 70% or more market share. Speaker 200:24:23So we have a very clear plan on how to go about that. And definitely, as we build on this initial launch activities, I think we'll be able to talk with more detail about how we are doing Operator00:24:44Our next question is from Anthony Petrone with Mizuho Securities. Please proceed. Speaker 300:24:51Thank you and good afternoon everyone. So maybe one just on the process of the FDA inspection and how long that actually takes and what the range of turnaround time is? So just trying to get an idea of timing and how the actual process plays out? And then on China specifically, a follow-up question there would be just on the stimulus package that was announced in March. There are some other healthcare consumer related companies that do see this as a potential catalyst into the second half of the year. Speaker 300:25:23So do you think China's stimulus could actually lead to upside as we get into the second half? Thanks again. Speaker 200:25:34Yes. Well, thank you, Anthony. On the first one, last time we were able to speak openly about it. What we talked about is that the FDA had given us a date for Q2. Can tell you now that pre approval inspection of our manufacturing facility in Costa Rica is scheduled to take place in less than 30 days. Speaker 200:25:58And our team is super well prepared and looking forward for it. In parallel, we have been making good progress with labeling and post market approval studies. And these are the last significant steps before the FDA approval. So we are getting very close to final stages on this and we want just to be very mindful of not disrupting that process. And on China and the stimulus package, yes, we're very well aware of it and we think it's a good development. Speaker 200:26:25It will take time to get through, so that it can really impact consumer demand. But we do see it as a positive. Remember, the lowest of the Chinese market in breast aesthetics happening actually in 2022. And since then, it's been bouncing back. Our expectation that is was that it was going to be back to 2019 levels by 2025, but maybe that stimulus package will be able to get us there faster. Speaker 300:26:56Thank you again. Operator00:27:00Our next question is from Matt Taylor with Jefferies. Please proceed. Speaker 700:27:07Great. Thanks for taking the question. Maybe I'll ask one on the EMEA commentary that you gave. I mean, it's encouraging to see that you're signing up all these centers. Was wondering if you could talk about how material the revenue contribution is going to be this year? Speaker 700:27:22And then maybe you could frame the centers that you're adding for Mia FEMTECH in terms of your overall centers, what percentage is that today and what do you think will be at maturity? Speaker 200:27:37Yes, I think with that one, Matt, at this point what I tell you is that what we are trying to do at the qualitative level, which is create the network of clinics and within those clinics start bringing in all of our marketing assets, the practice development, all the things that we provide so that you can have the new category really coming to light in there. I can see that some clinics who started in Europe for instance in September, October of last year have started to get to the numbers where we would like to see them in terms of number of procedures per month. We still have work to do to see those numbers in every single one of the centers, but that's part of the entire process of building a new category. So we're not in a rush. However, I think that having signed up 55 clinics already, 33 who are active right now, of those of course, the ones that are, that have started in the fall of last year are the ones of course that are getting more cases at this point. Speaker 200:28:48In addition, we have 37 new clinics under negotiation. We have this aspirational goal of getting to 100 clinics by the end of this year. And I think after that, you would what our expectations are is that in every Tier 1 city, there will be a few of these clinics. In every Tier 2 city, there will be a couple of those. And in some Tier 3 cities, you'll see 1. Speaker 200:29:09And when you start putting those numbers in and you start getting to the levels at which we see the initial clinics, I think we get an understanding of how quickly this can ramp up. But in 2024, it is mostly qualitative. But you will start seeing more revenue coming out of EMEA. We are very dedicated to the qualitative part. It is not time yet to break out EMEA revenue, but I think when it becomes material, we will be the first ones willing to do that. Speaker 700:29:42Great. Thanks, JJ. Maybe just one follow-up on China. It seems like everything is going well there. I just wanted to confirm more specifically, you talked about just the $10,000,000 in stocking revenue kind of spread out through the first half of the year and that was it for the guidance. Speaker 700:29:58Is that still your assumption and are you seeing any reordering yet? Speaker 100:30:03It's still early. Juan, as I mentioned, I mean, we've been there just a couple of months now. We launched in January. So it is tracking as we expected to the numbers you described. We'll see how the reordering starts to build in the back half of the year, but so far things are tracking. Speaker 700:30:20Okay. All right. Thank you. Thanks, Raj. Operator00:30:24Our next question is from Joanne Wuensch with Citibank. Please proceed. Speaker 800:30:31Thank you for taking the question and very nice quarter. I appreciate the commentary on the guidance that it is early in the year, but you did exceed consensus. And I'm curious how you think about the next couple of quarters. I just want to make sure that the second, third and fourth quarters are sort of set up appropriately. Speaker 100:30:51Yes, I think Joanne as we mentioned, you look at the sequential increase in the Q1 over last quarter in about $6,000,000 I think a similar sequential increase into the Q2 is the right way to think about it. The back half of the year, again, we'll see likely a small sequential increase in the 3rd, it tends to be the weakest of the quarters for us as the year unfolds, but you have the dynamic of the recovery in the markets. So we'll see growth into the Q3 as well. So generally it gets back to the commentary made about this recovery that we're seeing in the markets, the distributor orders improving. So I think that's probably a good way to think about it over the balance of the year. Speaker 800:31:34Thank you. And then is there anything that you could share regarding your go to market strategy in the United States? I'm thinking pricing, number of sales people you would need or anything else that you're comfortable sharing at this stage of the process? Thank you. Speaker 200:31:49Yes, unfortunately Joanne it's for competitive reasons this is exactly the type of things that we cannot give out. We have a very clear understanding of how we want to price in the United States. We are coming in with 2 products, Motiva SmoothSilk Round and Motiva SmoothSilk Ergonomics. Those are some of our best selling products in our international market and have been so for many years. And we will make the necessary investments to make sure that we provide the accounts as we move into different quarters after the launch, the necessary service that they deserve. Speaker 200:32:27So at this point, that's all I can tell you. Speaker 800:32:30I appreciate that. Thank you. Operator00:32:34Our final question is from Josh Jennings with TD Cowen. Please proceed. Speaker 900:32:41Hi, good afternoon. Thanks a lot. I was hoping to follow-up on Mia first. And just in the past, Juan Jose, your team has talked about your MIA partner clinics becoming $1,000,000 revenue generators for establishment labs? I mean, it sounds like these early launch trends are positive, but to get to that $1,000,000 per account, you had some relatively conservative assumptions. Speaker 900:33:07I just wanted to sanity check, make sure that that's your team is still optimistic that that revenue run rate per partner clinic is still in play potentially? Speaker 200:33:20Yes. Thank you, Josh. In the direct market, a MIA clinic that is doing an average for a year 24 cases per month will eventually lead to approximately $1,000,000 that is recognized by Establishment Labs. We think that number is achievable. Like I said, a couple of the clinics that began last fall are starting to trend to those numbers. Speaker 200:33:47So that's what gives us a conviction that those numbers can be achieved. And our job now is to expand the network of clinics to cities, for instance, across our direct markets in Europe. Some of the distributor markets have already kicked in. You can see in the social media handle of MiaFemtek, a lot of the work that has been done, for instance, to launch in several cities across the Middle East. So all of that tells you that we are building something special. Speaker 200:34:17And when you think about the current market for breast aesthetics, it's a market that is growing at low single digits at best. And what Mia brings is this new shiny object and what we see is that those numbers are not something that we see as unachievable and what we would like to see is that clinics in the 1st or second year depending on them being Tier 1 or Tier 2 city clinics can get there. Speaker 900:34:51Great. And appreciate some of the color on the U. S. FluorA launch. I was hoping to just check-in on the state of affairs of the Recon franchise internationally, both on the tissue expander side and on the implant side. Speaker 900:35:06Any updates you can provide just on traction there in Europe and other regions? Thanks for taking the questions. Speaker 200:35:16Yes. On that one, Josh, again, like I think what we've said many times is that breast reconstruction is slower because you're not really convincing just a plastic surgeon, you have to convince the plastic surgeons of a reconstructive department in a hospital and then wait for a tender to take place. So that's why although we see great feedback from the hospitals who have adopted, Flora and who have started to use with Flora, our breast implants, it's still not going at the same speed of adoption that we normally see when we go into a market on purely aesthetics. However, over time it will build and I think it's a big demonstration of our technology and our women's health credentials in this industry. Speaker 900:36:11Appreciate that. Thanks. Operator00:36:15That is all the time we have for questions today. I will now turn the call back over to Juan Jose for closing remarks. Speaker 200:36:23Thank you for joining us on today's call. We look forward to providing our next quarterly update in August, and we wish everyone continued good health and happiness. Operator00:36:34Thank you. This concludes today's conference. You may disconnect your lines at this time and thank you for your participation.Read morePowered by