Establishment Labs Q4 2023 Earnings Report $34.52 +7.21 (+26.40%) Closing price 04/9/2025 04:00 PM EasternExtended Trading$36.10 +1.58 (+4.59%) As of 04/9/2025 06:38 PM 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-$0.79Consensus EPS -$0.95Beat/MissBeat by +$0.16One Year Ago EPS-$0.55Establishment Labs Revenue ResultsActual Revenue$31.60 millionExpected Revenue$31.44 millionBeat/MissBeat by +$160.00 thousandYoY Revenue Growth-27.90%Establishment Labs Announcement DetailsQuarterQ4 2023Date2/28/2024TimeAfter Market ClosesConference Call DateWednesday, February 28, 2024Conference Call Time4:30PM ETUpcoming EarningsEstablishment Labs' Q1 2025 earnings is scheduled for Tuesday, May 6, 2025, with a conference call scheduled on Wednesday, May 7, 2025 at 4:30 PM ET. Check back for transcripts, audio, and key financial metrics as they become available.Conference Call ResourcesConference Call AudioConference Call TranscriptPress Release (8-K)Annual Report (10-K)SEC FilingEarnings HistoryESTA ProfilePowered by Establishment Labs Q4 2023 Earnings Call TranscriptProvided by QuartrFebruary 28, 2024 ShareLink copied to clipboard.There are 9 speakers on the call. Operator00:00:00Good afternoon. Welcome to Establishment Labs 4th Quarter 2023 Earnings Call. At this time, all participants will be in a listen only mode. At the end of this call, we will open the line for a question and answer session. Instructions will follow at that time. Operator00:00:15As a reminder, today's call is being recorded. I will now turn the call over to Raj Denhoy, Chief Financial Officer. Please go Speaker 100:00:29ahead. You, operator, and thank you, everyone, for joining us. With me today is Juan Jose Tricone Quiros, our Chief Executive Officer. Following our prepared remarks, we'll take your questions. Before 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. Speaker 100:00:45These 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 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 establishmentlabs.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 the company's earnings, which can be stated as adjusted EBITDA. Reconciliations to comparable GAAP financial measures or non GAAP measures, if available, may be found in today's press release, which is available on our website. Speaker 100:01:38Please also note that Establishment 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 specific product availability. The content of this conference call contains time sensitive information accurate only as of the date of this live broadcast, February 28, 2024. Except as required by law, Establishment Labs undertakes no obligation to revise or otherwise update any statement to reflect DaVinci's circumstances after the date of this call. Speaker 100:02:12With that, it is my pleasure to turn the call over to our CEO, Juan Jose. Speaker 200:02:17Thank you, Raj, and good afternoon, everyone. Revenue in the Q4 of 2023 totaled $31,600,000 in line with the range we pre announced in early January. While our second half results reflected lower demand for breast procedures globally, our markets are stabilizing and we are seeing improving demand including from our distributors. Our global market check suggest that we will have continued improvement throughout 2024. Given this, we are setting guidance in the range of 174 $1,000,000 to $184,000,000 representing growth of 5% to 11%. Speaker 200:02:58This guidance does not include the launch of Motiva Implants in the United States, which would significantly improve both our revenue and growth. 2024, 20th anniversary of our founding is a pivotal year for Establishment Labs. With the approval of our implants in China and our pending approval in the United States, we are becoming a true global player in our industry. We are well positioned for multiyear growth and poised to take global market leadership in an industry that has not brought any meaningful innovation to market in more than 2 decades. 2024 is also the year in which we will achieve the necessary scale to become EBITDA positive with a clear path to cash flow positive. Speaker 200:03:40Since we launched Motiva 14 years ago, we have been in the most price sensitive markets with low ASPs and gross margins. Our entries into China and the United States provide the necessary market dynamics for a healthy business model with significant growth. We have taken and continue to take a number of steps to reduce cash burn and expect cash used to be less than $48,000,000 It is worth reiterating that we remain focused on achieving positive EBITDA by the end of this year and turning cash flow positive in 2025. As we prepare for growth ahead, we have taken tangible steps to focus our business on the areas of highest returns. In this process, we have reduced global headcount by approximately 28% and have reprioritized our operating spending. Speaker 200:04:31The impact of these initiatives can be seen in the reduction in cash use in the 4th quarter to $12,200,000 This was less than 1 third of our cash use in the 2nd and third quarters of 2023. This focus on improved efficiency and cash use is core to our budgeting process and is a significant part of how management will be compensated this year. In early January, we added to our balance sheet with a $50,000,000 private placement, bringing our pro form a cash position to approximately $90,000,000 Last week, we announced an amendment to our existing credit facility with Oaktree Capital. The amendment updated the terms under which we can draw an additional $50,000,000 in non dilutive financing. The first $25,000,000 is available in FDA approval of Notiva in the United States. Speaker 200:05:24While we are committed to achieving cash flow breakeven with the cash we have, the availability of this capital should we need it helps further de risk the full execution of our U. S. Launch strategy. Raj will provide additional details on our Q4 performance and our outlook in a moment, but I would like to provide some additional detail on our most important near term initiatives, the United States, China and MiyaFemtek. In the United States, the first case with our Motiva Fluorab tissue expander was performed in late December by a surgical team led by Doctor. Speaker 200:05:59Mark Clements at the University of Texas, MD Anderson Cancer Center in Houston, Texas. FLORA is initially being made available to a limited number of centers of excellence in the United States. We are working through the back process with a first list of 15 centers of excellence across the country. As these premier cancer centers adopt FLORA, the benefits of this unique expander are making clear that there is a new standard in breast reconstruction. FLORA includes our patented SmoothSilk Surface technology as well as an RFID enabled non magnetic port and is labeled as MR conditional by the FDA. Speaker 200:06:39By being magnet free, Fluora avoids the interference that magnets cause during MR imaging and can improve the precision of radiation oncology treatments. This is a distinct advantage to FLORA as all other commercially available breast tissue expanders include magnets. FLORA defines a new era for breast reconstruction and it will help further transform breast cancer into a treatable disease from which women can fully recover. For our Motiva Implants, our PMA remains under review by the FDA. Our interactions with the agency on Motiva remain very positive and we continue to make progress. Speaker 200:07:17We do not yet have a date for the GMP inspection, but given our regular interactions with the agency, we expect to receive notification very soon. Our team is ready for and we have over a decade of experience in audits from high vigilance authorities. So far this year, we have had our MDSAP surveillance audit, which includes compliance with medical device regulations from the United States, Canada, Europe, Brazil, Japan and Australia for our 3 manufacturing sites in Costa Rica. We also had our quality management system surveillance audit for the latest MDR European Medical Device Regulations. These audits resulted in the renewal of our certifications and the recommendation for inclusion of our latest manufacturing unit at the Surajun. Speaker 200:08:08Mia FEMTECH is creating an entirely new true minimally invasive category within breast aesthetics and the list of countries where MIA is available continues to grow. We have partner sites in Japan, Spain, France, Sweden, Switzerland, Germany and Costa Rica and we have partnered with distributors in the United Kingdom, Turkey, Poland and the Middle East to begin opening sites in those regions in 2024. We now have 17 centers certified to offer the Mee experience across 15 cities in Japan, Switzerland, Spain, France, Germany and Sweden with 39 certified plastic surgeons performing MIA. We are in the process of onboarding an additional 15 new centers across Europe and the Middle East with 31 additional plastic surgeons. We have also signed 20 new centers which will begin the process of onboarding in the first half of this year. Speaker 200:09:07On top of that, we have a lot of interest from the best plastic surgery clinics who see the business opportunity with the expansion into minimally invasive breast aesthetics and we are in advanced negotiations with 16 such clinics. Mia is gaining appeal with a new consumer. Of the women who experience MIA, so far 38% were not considering breast augmentation prior to MIA. The average consideration time among these women was less than 2 months versus 3 to 7 years for traditional breast augmentation and the average price paid for MIA was 70% or more higher than a traditional procedure. Moreover, the testimonials from women reinforce the value proposition based on convenience, quick recovery and excellent aesthetic outcomes. Speaker 200:09:55It is still early in the launch of Mia, but we are seeing proof points that we are creating and capturing new consumer demand in this new category in breast aesthetics. In China, we held a series of events during the 1st week of January to formally launch Motiva with our exclusive distribution partner. We held special events in Shanghai, Guangzhou, Shenzhen and Hainan. Supported by our partner additional medical education events have been taking place in different cities in China and will continue throughout the year. China is the 2nd largest market for breast augmentation and has among the highest ASPs in the world. Speaker 200:10:35Our research confirms that there is a large segment in the Chinese market willing to pay significantly higher prices for the perceived value of the highest quality products. We expect our share in the Chinese market will mirror the success we have seen in surrounding markets of Asia. In markets like South Korea, Japan, Thailand, Vietnam, Singapore, Hong Kong and Taiwan, we hold the number one market share position and China should match this success over time. I will now turn the call over to Rob. Speaker 100:11:09Thank you, Anoj. Total revenue for the Q4 was $31,600,000 a decline of 28% from the year ago period. Currency had a Rec sales in the 4th quarter were approximately 49% of implant sales, while distributors made up the balance. From a regional perspective, sales in Europe, Middle East and Africa were approximately 53% of the global total Asia Pacific 19% and Latin America 27%. Brazil, which is our largest market globally accounted for approximately 10% of total quarterly sales. Speaker 100:11:42Our gross profit for the Q4 was $20,600,000 or 65.2 percent of revenue, compared to $28,200,000 or 64.3 percent of revenue for the same period in 2022. Our gross profit in the 4th quarter was negatively impacted by an obsolescence charge, without which gross margins would have been approximately 66%. Our gross margin was also impacted by higher overhead and labor costs. Costs were higher in part from changes in foreign exchange rates between the U. S. Speaker 100:12:08Dollar and the Costa Rican cologne. As we report in U. S. Dollars, the strengthening of the colon over the last year resulted in higher reported costs. Average selling prices in the Q4 were up from the Q3 of 2023 and year over year. Speaker 100:12:23SG and A expenses for the 4th quarter increased approximately $2,000,000 to $36,900,000 compared to $34,900,000 in the Q4 of 2022. The increase in SG and A in the Q4 resulted in part from our investments in new growth initiatives like EMEA and preparations for our launch in the U. S. These were offset by the significant cost reduction initiatives we undertook in the quarter. SG and A declined $3,100,000 sequentially from the Q3. Speaker 100:12:48R and D expenses for the 4th quarter declined approximately $700,000 from the same quarter a year ago to $5,800,000 and were down $1,300,000 sequentially. Total operating expenses for the Q4 were $42,700,000 an increase of approximately $1,400,000 from the year ago period. Operating expenses declined approximately $4,400,000 from the 3rd quarter due primarily to cost reduction initiatives in the quarter. Net loss from operations for the Q4 was $22,100,000 compared to a net loss of $13,200,000 in the same period in 2022. Our cash position as of December 31 was $40,000,000 compared to $66,400,000 at the end of 2022. Speaker 100:13:32Our cash used in the 4th quarter was $12,200,000 which compared to $38,000,000 in the previous quarter. With the $50,000,000 private placement in January, our pro form a cash position increased to $90,000,000 Last week, we also amended our credit facility with Oaktree. The milestones under which we can access the 2 remaining tranches on our debt facility, which totaled $50,000,000 were amended to allow us to access the first $25,000,000 on U. S. FDA approval of Motiva Implants and the second with the additional milestone of achieving $195,000,000 in trailing 12 month sales. Speaker 100:14:06For 2024, our guidance excludes the contribution of Motiva Implants approved in the United States. We are guiding to a revenue range of $174,000,000 to $184,000,000 representing growth of 5% to 11%. We expect currency to have a minimal impact on our sales results this year. We expect gross margins in 2024 to be approximately 100 basis points higher than 2023 to a range of 65.5% to 66%. We've taken a number of steps to lower cash use in 2024. Speaker 100:14:34Efforts include the reduction of global personnel by approximately 28%, targeted reductions in operating expenses and management of inventory levels. As a result, we expect cash used before financing in 2024 to be less than $48,000,000 With these actions, we expect to achieve positive adjusted EBITDA in 2024 and positive cash flow in 2025. I will now turn the call back to Juan Jose. Speaker 200:14:58Thank you, Raj. Establishment Labs was founded on bringing differentiated technology to an industry that has seen little innovation for decades. Unlike our competitors, we have grounded our products in true science and innovation and the clinical and scientific data clearly demonstrate our technologies have no parallel in this industry. We are now launching our technologies into China and the United States, the 2 largest highest priced and highest gross margin markets in the world. In our current markets, FluorA is constructing a new standard in breast reconstruction and Mia is creating an entirely new and higher value category in breast aesthetics. Speaker 200:15:37We are acutely focused on creating shareholder value and a significant piece of this is to get to cash flow positive as soon as possible. We are confident in our ability to do this early next year and have modeled our cash spend accordingly. With the cash we have on hand and the amendment to our credit facility, we are in an excellent position to fund our growth initiatives while meeting our profitability targets. 2024 will be one of the most important in our 20 year history. We are entering this year with a solid foundation and with a clear path to become the leading global company in breast aesthetics and reconstruction. Speaker 200:16:14I will now turn the call over to the operator for your questions. Operator00:16:19Thank Our first question is from Alan Ng with JPMorgan. Please proceed. Speaker 300:16:46Thanks for the question. Speaker 400:16:48I had a quick one to start off on China. The approval came a little bit later than expected, but you were previously expecting a contribution of in the low teens in Q4. Now some of that stocking, not all underlying quarterly demand. But how should we think about your assumptions for China contribution this year in light the fact that you're not assuming any contribution from the U. S? Speaker 100:17:16Yes. Thanks, Alan. I think when we lowered the guidance coming out of the Q3 for 2023, we talked about China being roughly $10,000,000 of the reduction in 2023. As we think about the contribution in 2024, that's a good place to start, right? We don't expect that's all going to come in the Q1. Speaker 100:17:36It should be spread out over the first 2 or 3 quarters of the year. But I think as a starting point for what China will contribute for us this year, I think that's a good place to start. Speaker 200:17:46Yes. Additionally, I think it's important to recognize that what we are doing now is holding educational events in Tier 1 and Tier 2 cities and our shipments in the first half of this year will mirror stocking taking place in those cities across China. And in the second half of the year, you should think more about some of the reordering starting to take place as demand for these procedures increase. Speaker 400:18:15Got it. And then a question kind of on broader market dynamics. When we think about the assumptions underpinning your guidance, in early January, you talked about how markets haven't necessarily recovered, but that previous weakness looks to have stabilized. What assumption do you have for the underlying market to get to your range? Should we think that the bottom half of the range assumes minimal improvement and the top half assumes more improvement? Speaker 400:18:41Just help us level set your expectations there. Thank you. Speaker 100:18:46Yes. No, I think, the way we think about it is, I think you're right. I mean, we are seeing the market stabilizing. We're seeing recovery in these markets. Things are not fully back to normal. Speaker 100:18:56I think as we look out over the course of the year and even some of the feedback we're already getting from the market is that things are picking up, things are improving. And so we do expect to see that stabilization to take hold over the year. In terms of the range, the top to the bottom, I mean, for us this year, I think as you described it, right, if we see a stronger recovery, a quicker recovery, it will probably push us towards the upper end. If things take a little bit longer, perhaps with the lower end. So we're starting this year, I think, from a kind of a conservative starting point. Speaker 100:19:27And again, we're seeing things improve out there, but it's going to take some time. Operator00:19:39Our next question is from Joanne Wuensch with Citi. Please proceed. Speaker 500:19:46Good evening and thank you for taking the question. One is sort of mechanical. I'm curious what you think your CapEx spend will be this year with the majority of your new facility behind you? And then my second question is a little bit more interesting, I hope, which is if you're seeing stabilization in demand, is it pocketed? Is it in certain regions? Speaker 500:20:08How do we think about stabilization transitioning towards higher demand and or growth? Thank you. Speaker 200:20:17Yes. Thank you for that. I think what takes us to this comments around markets recovering and us seeing some of the stabilization taking place, we see this happening at different speed in different regions. For instance, Brazil, I think it's still not in the right place, but we see Asia picking up again. We also see in our direct markets in Europe, demand picking up as well. Speaker 200:20:46So I think it's not going to happen all at once. But we're not the only company seeing the recovery in aesthetics. And that includes, of course, breast aesthetics and reconstruction. Speaker 100:20:57Yes. And on your question on CapEx, we did see stronger or heavier CapEx over the last couple of years as we were completing the new facility in Costa Rica, which you've been to. As we look out in 2024, there still is some work to be done on that facility. We also, as we've noted, we are investing in the United States. And so I think CapEx for us will still be something in the order of about $20,000,000 That's captured in the guidance we've given of the overall cash use being less than $48,000,000 this year. Speaker 500:21:27Thank you. Operator00:21:31Our next question is from Anthony Pettone with Mizuho Group. Please proceed. Anthony, your line is live. Please check if you're muted. Our next question is from Josh Jennings with TD Cowen. Operator00:21:57Please proceed. Speaker 600:22:00Hi, good afternoon. Thanks for taking the questions. I was hoping to just get some comments on Jose on your views on the state of the U. S. Breast implant market. Speaker 600:22:10I know you guys haven't launched yet, but future competitor announced or filed for bankruptcy and it seems like an opportune time for SABLXMLB to launch Motiva in the coming months. So maybe just the state of affairs there. And does this change your strategy on the U. S. Fluoro launch? Speaker 600:22:30I think Accenture had a relatively strong recon franchise. Speaker 200:22:37Yes, thanks Josh. So in the U. S. Market what you see is about 95% of procedures take place with round smooth implants that have very little difference between them. And with nothing to separate the offerings in the market, the basis of competition is not on the merits of the technology. Speaker 200:22:58So it's not surprising that in that situation the smallest of company was not able to survive. But I think that probably the slowdown in statics overall probably exacerbated the demise of that company. But overall, I think that just like any other slowdown that we have seen in the past, eventually it goes back. In 2008, 2009, it was about around 10% of procedures affected for 2 years, but eventually it came back and then came back higher. I think the U. Speaker 200:23:36S. Market is starting to pick up again from what we hear from different indicators. And yes, of course, as we look into the expansion of FLAURA, this provides for an opportunity for us to be able to bring our fully differentiated tissue expander to U. S. Centers of Excellence. Speaker 600:24:04Great, thanks. And then just I know you haven't detailed and it's a little bit premature to detail the U. S. Commercial launch strategy. But just in terms of the initial spend, the investments that have already been made versus the investments that are required as you move closer to launch and then execute the launch and just considering the updated status of your balance sheet. Speaker 600:24:26Anything you can share just on terms of investments made versus investments to be made in the coming months in front of the launch? Thanks a lot. Speaker 100:24:36Yes, sure. We have been investing in the U. S. I think as we've been building the infrastructure here to be a commercial organization, if you think about finance, logistics, the things you need to be commercial, so that spending has been taking place and we're actually leveraging that now as we've launched Fluor in the United States and are starting to see traction with that product. When we get closer to the approval of the implants in the United States, we will start to see a pickup in spending relative to commercial activity. Speaker 100:25:04But given the higher ASPs in the U. S, the higher margin here, the ability we have to leverage the spending, we've already done as well as the infrastructure we have outside the United States, the period of time which we're loss making in the U. S. Should be relatively short. I think as we noted in the prepared remarks, the amendment to the Oaktree facility also gives us additional capital should we need it to fully fund the U. Speaker 100:25:29S. Launch strategy. So we're feeling pretty good about where we are in terms of getting ready for being commercial with our entire portfolio in the U. S. Operator00:25:44Our next question is from George sellers with Stephens Incorporated. Please proceed. Speaker 700:25:50Good afternoon and thanks for taking the question. 2 parter here on Flora. Just curious, first of all, what your guidance assumes, if any, for Flora contribution in 2024? And then could you also just speak to the commercial process for Flora and breast reconstruction in the hospital as compared to commercialization in the breast augmentation market? Speaker 200:26:16Yes. Thanks, George. When you launch products, especially products that have such differentiation, a lot of your focus at the beginning is on the qualitative part. Still you heard our numbers, we have 15 centers that are working through the VAC process. That process takes time, but you're already seeing us getting into these hospitals in the first half of this year and we'll continue adding to that. Speaker 200:26:51But it's early on to be able to give you precision on what we expect for FLORA. Now overall, it is $180,000,000 market and we are selling our tissue expand at our premium. So we do expect this to eventually be an important contributor over the next few years to our growth. And definitely, it has the highest ASPs in the world and the highest gross margins for any market for tissue expanders. Speaker 700:27:23Okay. That's really helpful. And then maybe shifting to EMEA. Could you give some additional color on what EMEA contributed in the quarter? And then also your expectations, I believe you've said there's another 30 or so potential clinics that you may add to the MIA clinics. Speaker 700:27:43But just curious your expectations for that progression in 2024 as well? Speaker 200:27:49Look, just like everyone, we are super excited with MIA, particularly because we see the amazing results and the differentiated experience. The fact that these women are just going back to their daily lives minus the exercise the same day is just an amazing thing to see. And that's why we're so confident on the growth of MIA. But just like I said before, when you're launching these type of products, you focus first on the qualitative. What we did today though is give you a lot of color on the number of centers. Speaker 200:28:22So just with the list we provided, it seems that we should be in about 70 centers this year at least. So the network of NIA certified centers is increasing and what we are seeing is in the first group of clinics that launched in the second half of last year, we are seeing increasing demand every month. And as we get through capillarity in these cities with more centers getting there, then we're going to see more demand. So, eventually, I think what we will try to do is on top of all the information we gave today on the number of centers is also give you an idea in the future of how that ramps up in terms of a number of procedures. But still a little bit early to go ahead in that and do that. Speaker 700:29:16Okay. Thank you all for the time. Operator00:29:20Our next question is from Marie Thibault with BTIG. Please proceed. Speaker 300:29:26Hey, good afternoon, everyone. This is Sam Ivar on for Marie. Thanks for taking the questions. Maybe I can start, Raj, on just an operating expense question and maybe your thoughts for 2024. And if any of these cuts that you made in the back half of last year, is there anything left to be recognized in Q1? Speaker 300:29:45Is that all behind us at this point? Speaker 100:29:50Yes. So I think there will be some additional spending in the Q1 relative to the Q4 in terms of cash use, again around severance costs and we do have heavier costs usually in the beginning of the year. And I think it's also important to note that we're continuing to look for efficiencies across the business, right. So in terms of getting to the stable position, we're not there yet and we will continue to look again at ways to make our business more efficient. We did take a lot of cost out of the base. Speaker 100:30:20So if you look at operating expenses last year versus this year, they will be down something around $25,000,000 or $30,000,000 from where we were in 2023. So I don't know if that answers your question, but in terms of cash use, we could see a little bit of a tick up in the Q1 again on some of the severance costs and the restructuring costs we've undertaken. Then over the course of the year, the overall expense base is going to be significantly lower than where it was last year. Speaker 300:30:43Yes. No, that's super helpful. Thanks for that. Maybe I can use just my follow-up here. I know we're getting close to maybe when we'd expect you guys to have maybe 4 year data from the pivotal trial. Speaker 300:30:57I know considering a lot of the back and forth with the FDA right now, I don't know if that's something you're looking to present or is that something maybe we should hold off on maybe seeing you guys present until you get approval? Speaker 200:31:11So, it is important to remember that the FDA per the guidance document on breast implant requires 3 year data which we have provided. However, as a woman's health company we're always been super transparent with data. We were the 1st company ever to provide data pre approval on the trial and we will continue to do so. So yes, the idea is to provide the 4 year data to the market after the FDA has received that data for our periodic interactions. And yes, and I think this data will show as it has shown in the past that we have an amazing technology with superior safety results. Speaker 300:32:02Great. Thanks for taking the questions. Operator00:32:12Our next question is from Anthony Petrone with Mizuho Group. Please proceed. Speaker 800:32:18Thanks. Apologies, just hopping between calls here. So maybe first just on the geographic sort of split for the aesthetics market. Are there any regions where you're starting to see green shoots where perhaps distributors are seeing more activity on the ground and are re upping on inventory stocking. So that would be question 1, just geographically how the market is playing out. Speaker 800:32:43And then maybe any thoughts on where the underlying aesthetic market is in the United States just ahead of a potential launch on Motiva into the second half? And then I'll have one follow-up for Raj on the middle of the P and L. Speaker 200:32:58Yes. So if you want to think about it by regions, I think that probably Latin America and most importantly Brazil have not recovered as quickly as other markets like in Asia we're starting to see that's a full distributor region for us by the way, but we're starting to see some of the activity coming back. And we are also seeing that across Europe and especially in our direct markets where we see that in real time. So we expect this to continue taking place at different speeds in these regions. But when we think about guidance for this year, I think what you should think of is conditions improving throughout this year. Speaker 200:33:42And the U. S. Was actually hit quite strongly by this global slowdown in aesthetics. But from different indicators, we know the situation is improving. And by the time we go to market, I think that we'll be in a good position to take over demand. Speaker 200:34:02And the fact that we might go to market with one less competitor, of course, adds up to the opportunity. Speaker 800:34:10No, absolutely. And then, Raj, just on the expense outlook, when you think about the Motiva trial eventually rolling off, I mean, what is the cost burden on the trial itself? And then when you think about reinvesting those dollars, is that happening now ahead of a launch or will it happen post FDA clearance? Thanks. Speaker 100:34:31Yes, it's a fair question. We are still incurring costs relative to that trial as we're moving to the FDA process. We were getting close to the approval, but there's still costs associated with it. Once the approval happens, that's we don't stop our clinical activity in the United States. We have products coming after that. Speaker 100:34:52Mia is an important one that will come to the United States, the Ergonomix II platform. So there will still continue to be costs associated with our regulatory activity in the United States. But I think in general, as we noted earlier, we've taken quite a bit of cost out of our base here in 2024. And so again, we're operating on a much more efficient basis and it does give us some flexibility as we move through the year to take advantage of some of these opportunities if we can. So I wouldn't expect that event of the U. Speaker 100:35:22S. Approval is really going to step down our spending here too dramatically. Speaker 800:35:28Helpful. Thank you. Operator00:35:35That is all the time that we have for questions today. I will now turn the call back over to Juan Jose for closing remarks. Speaker 200:35:43Thank you for joining us in today's call. We look forward to providing our next quarterly update in May, and we wish everyone continued good health and happiness. Operator00:35:53Thank you. This will conclude today's conference. You may disconnect your lines at this time and thank you for your participation.Read moreRemove AdsPowered by Conference Call Audio Live Call not available Earnings Conference CallEstablishment Labs Q4 202300:00 / 00:00Speed:1x1.25x1.5x2xRemove Ads Earnings DocumentsPress Release(8-K)Annual report(10-K) Establishment Labs Earnings HeadlinesTD Cowen Keeps Their Buy Rating on Establishment Labs Holdings (ESTA)April 4, 2025 | markets.businessinsider.comIs Now The Time To Look At Buying Establishment Labs Holdings Inc. (NASDAQ:ESTA)?March 22, 2025 | finance.yahoo.comThe Most Bullish Metric For Stocks (NOT Volume…)Before placing a single trade, Tim Sykes always checks one key bullish metric. It’s the same signal that has shown up ahead of explosive stock moves — sometimes 100%, 500%, or even 1,000% in a single day. After months of development, his team has turned this metric into a simple, easy-to-use indicator that’s accessible to everyone. It’s designed with day traders in mind and built to help identify potential momentum before it happens.April 10, 2025 | MillPub (Ad)Establishment Labs Notes Presentation of 5-Year Results from Motiva U.S. IDE Study at The Aesthetic MEET 2025March 20, 2025 | finance.yahoo.comEstablishment Labs price target lowered to $60 from $75 at TD CowenMarch 19, 2025 | markets.businessinsider.comEstablishment Labs® Announces Meghan Trainor as Brand Partner Following Her Breast Augmentation with Motiva Implants®March 6, 2025 | prnewswire.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 Lamb Weston Stock Rises, Earnings Provide Calm Amidst ChaosIntuitive Machines Gains After Earnings Beat, NASA Missions AheadCintas Delivers Earnings Beat, Signals More Growth AheadNike Stock Dips on Earnings: Analysts Weigh in on What’s NextAfter Massive Post Earnings Fall, Does Hope Remain for MongoDB?Semtech Rallies on Earnings Beat—Is There More Upside?These 3 Q1 Earnings Winners Will Go Higher Upcoming Earnings Bank of New York Mellon (4/11/2025)BlackRock (4/11/2025)JPMorgan Chase & Co. (4/11/2025)Progressive (4/11/2025)Wells Fargo & Company (4/11/2025)The Goldman Sachs Group (4/14/2025)Interactive Brokers Group (4/15/2025)Bank of America (4/15/2025)Citigroup (4/15/2025)Johnson & Johnson (4/15/2025) Get 30 Days of MarketBeat All Access for Free Sign up for MarketBeat All Access to gain access to MarketBeat's full suite of research tools. Start Your 30-Day Trial MarketBeat All Access Features Best-in-Class Portfolio Monitoring Get personalized stock ideas. Compare portfolio to indices. Check stock news, ratings, SEC filings, and more. Stock Ideas and Recommendations See daily stock ideas from top analysts. Receive short-term trading ideas from MarketBeat. Identify trending stocks on social media. Advanced Stock Screeners and Research Tools Use our seven stock screeners to find suitable stocks. Stay informed with MarketBeat's real-time news. Export data to Excel for personal analysis. Sign in to your free account to enjoy these benefits In-depth profiles and analysis for 20,000 public companies. Real-time analyst ratings, insider transactions, earnings data, and more. Our daily ratings and market update email newsletter. Sign in to your free account to enjoy all that MarketBeat has to offer. Sign In Create Account Your Email Address: Email Address Required Your Password: Password Required Log In or Sign in with Facebook Sign in with Google Forgot your password? Your Email Address: Please enter your email address. Please enter a valid email address Choose a Password: Please enter your password. Your password must be at least 8 characters long and contain at least 1 number, 1 letter, and 1 special character. Create My Account (Free) or Sign in with Facebook Sign in with Google By creating a free account, you agree to our terms of service. This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
There are 9 speakers on the call. Operator00:00:00Good afternoon. Welcome to Establishment Labs 4th Quarter 2023 Earnings Call. At this time, all participants will be in a listen only mode. At the end of this call, we will open the line for a question and answer session. Instructions will follow at that time. Operator00:00:15As a reminder, today's call is being recorded. I will now turn the call over to Raj Denhoy, Chief Financial Officer. Please go Speaker 100:00:29ahead. You, operator, and thank you, everyone, for joining us. With me today is Juan Jose Tricone Quiros, our Chief Executive Officer. Following our prepared remarks, we'll take your questions. Before 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. Speaker 100:00:45These 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 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 establishmentlabs.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 the company's earnings, which can be stated as adjusted EBITDA. Reconciliations to comparable GAAP financial measures or non GAAP measures, if available, may be found in today's press release, which is available on our website. Speaker 100:01:38Please also note that Establishment 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 specific product availability. The content of this conference call contains time sensitive information accurate only as of the date of this live broadcast, February 28, 2024. Except as required by law, Establishment Labs undertakes no obligation to revise or otherwise update any statement to reflect DaVinci's circumstances after the date of this call. Speaker 100:02:12With that, it is my pleasure to turn the call over to our CEO, Juan Jose. Speaker 200:02:17Thank you, Raj, and good afternoon, everyone. Revenue in the Q4 of 2023 totaled $31,600,000 in line with the range we pre announced in early January. While our second half results reflected lower demand for breast procedures globally, our markets are stabilizing and we are seeing improving demand including from our distributors. Our global market check suggest that we will have continued improvement throughout 2024. Given this, we are setting guidance in the range of 174 $1,000,000 to $184,000,000 representing growth of 5% to 11%. Speaker 200:02:58This guidance does not include the launch of Motiva Implants in the United States, which would significantly improve both our revenue and growth. 2024, 20th anniversary of our founding is a pivotal year for Establishment Labs. With the approval of our implants in China and our pending approval in the United States, we are becoming a true global player in our industry. We are well positioned for multiyear growth and poised to take global market leadership in an industry that has not brought any meaningful innovation to market in more than 2 decades. 2024 is also the year in which we will achieve the necessary scale to become EBITDA positive with a clear path to cash flow positive. Speaker 200:03:40Since we launched Motiva 14 years ago, we have been in the most price sensitive markets with low ASPs and gross margins. Our entries into China and the United States provide the necessary market dynamics for a healthy business model with significant growth. We have taken and continue to take a number of steps to reduce cash burn and expect cash used to be less than $48,000,000 It is worth reiterating that we remain focused on achieving positive EBITDA by the end of this year and turning cash flow positive in 2025. As we prepare for growth ahead, we have taken tangible steps to focus our business on the areas of highest returns. In this process, we have reduced global headcount by approximately 28% and have reprioritized our operating spending. Speaker 200:04:31The impact of these initiatives can be seen in the reduction in cash use in the 4th quarter to $12,200,000 This was less than 1 third of our cash use in the 2nd and third quarters of 2023. This focus on improved efficiency and cash use is core to our budgeting process and is a significant part of how management will be compensated this year. In early January, we added to our balance sheet with a $50,000,000 private placement, bringing our pro form a cash position to approximately $90,000,000 Last week, we announced an amendment to our existing credit facility with Oaktree Capital. The amendment updated the terms under which we can draw an additional $50,000,000 in non dilutive financing. The first $25,000,000 is available in FDA approval of Notiva in the United States. Speaker 200:05:24While we are committed to achieving cash flow breakeven with the cash we have, the availability of this capital should we need it helps further de risk the full execution of our U. S. Launch strategy. Raj will provide additional details on our Q4 performance and our outlook in a moment, but I would like to provide some additional detail on our most important near term initiatives, the United States, China and MiyaFemtek. In the United States, the first case with our Motiva Fluorab tissue expander was performed in late December by a surgical team led by Doctor. Speaker 200:05:59Mark Clements at the University of Texas, MD Anderson Cancer Center in Houston, Texas. FLORA is initially being made available to a limited number of centers of excellence in the United States. We are working through the back process with a first list of 15 centers of excellence across the country. As these premier cancer centers adopt FLORA, the benefits of this unique expander are making clear that there is a new standard in breast reconstruction. FLORA includes our patented SmoothSilk Surface technology as well as an RFID enabled non magnetic port and is labeled as MR conditional by the FDA. Speaker 200:06:39By being magnet free, Fluora avoids the interference that magnets cause during MR imaging and can improve the precision of radiation oncology treatments. This is a distinct advantage to FLORA as all other commercially available breast tissue expanders include magnets. FLORA defines a new era for breast reconstruction and it will help further transform breast cancer into a treatable disease from which women can fully recover. For our Motiva Implants, our PMA remains under review by the FDA. Our interactions with the agency on Motiva remain very positive and we continue to make progress. Speaker 200:07:17We do not yet have a date for the GMP inspection, but given our regular interactions with the agency, we expect to receive notification very soon. Our team is ready for and we have over a decade of experience in audits from high vigilance authorities. So far this year, we have had our MDSAP surveillance audit, which includes compliance with medical device regulations from the United States, Canada, Europe, Brazil, Japan and Australia for our 3 manufacturing sites in Costa Rica. We also had our quality management system surveillance audit for the latest MDR European Medical Device Regulations. These audits resulted in the renewal of our certifications and the recommendation for inclusion of our latest manufacturing unit at the Surajun. Speaker 200:08:08Mia FEMTECH is creating an entirely new true minimally invasive category within breast aesthetics and the list of countries where MIA is available continues to grow. We have partner sites in Japan, Spain, France, Sweden, Switzerland, Germany and Costa Rica and we have partnered with distributors in the United Kingdom, Turkey, Poland and the Middle East to begin opening sites in those regions in 2024. We now have 17 centers certified to offer the Mee experience across 15 cities in Japan, Switzerland, Spain, France, Germany and Sweden with 39 certified plastic surgeons performing MIA. We are in the process of onboarding an additional 15 new centers across Europe and the Middle East with 31 additional plastic surgeons. We have also signed 20 new centers which will begin the process of onboarding in the first half of this year. Speaker 200:09:07On top of that, we have a lot of interest from the best plastic surgery clinics who see the business opportunity with the expansion into minimally invasive breast aesthetics and we are in advanced negotiations with 16 such clinics. Mia is gaining appeal with a new consumer. Of the women who experience MIA, so far 38% were not considering breast augmentation prior to MIA. The average consideration time among these women was less than 2 months versus 3 to 7 years for traditional breast augmentation and the average price paid for MIA was 70% or more higher than a traditional procedure. Moreover, the testimonials from women reinforce the value proposition based on convenience, quick recovery and excellent aesthetic outcomes. Speaker 200:09:55It is still early in the launch of Mia, but we are seeing proof points that we are creating and capturing new consumer demand in this new category in breast aesthetics. In China, we held a series of events during the 1st week of January to formally launch Motiva with our exclusive distribution partner. We held special events in Shanghai, Guangzhou, Shenzhen and Hainan. Supported by our partner additional medical education events have been taking place in different cities in China and will continue throughout the year. China is the 2nd largest market for breast augmentation and has among the highest ASPs in the world. Speaker 200:10:35Our research confirms that there is a large segment in the Chinese market willing to pay significantly higher prices for the perceived value of the highest quality products. We expect our share in the Chinese market will mirror the success we have seen in surrounding markets of Asia. In markets like South Korea, Japan, Thailand, Vietnam, Singapore, Hong Kong and Taiwan, we hold the number one market share position and China should match this success over time. I will now turn the call over to Rob. Speaker 100:11:09Thank you, Anoj. Total revenue for the Q4 was $31,600,000 a decline of 28% from the year ago period. Currency had a Rec sales in the 4th quarter were approximately 49% of implant sales, while distributors made up the balance. From a regional perspective, sales in Europe, Middle East and Africa were approximately 53% of the global total Asia Pacific 19% and Latin America 27%. Brazil, which is our largest market globally accounted for approximately 10% of total quarterly sales. Speaker 100:11:42Our gross profit for the Q4 was $20,600,000 or 65.2 percent of revenue, compared to $28,200,000 or 64.3 percent of revenue for the same period in 2022. Our gross profit in the 4th quarter was negatively impacted by an obsolescence charge, without which gross margins would have been approximately 66%. Our gross margin was also impacted by higher overhead and labor costs. Costs were higher in part from changes in foreign exchange rates between the U. S. Speaker 100:12:08Dollar and the Costa Rican cologne. As we report in U. S. Dollars, the strengthening of the colon over the last year resulted in higher reported costs. Average selling prices in the Q4 were up from the Q3 of 2023 and year over year. Speaker 100:12:23SG and A expenses for the 4th quarter increased approximately $2,000,000 to $36,900,000 compared to $34,900,000 in the Q4 of 2022. The increase in SG and A in the Q4 resulted in part from our investments in new growth initiatives like EMEA and preparations for our launch in the U. S. These were offset by the significant cost reduction initiatives we undertook in the quarter. SG and A declined $3,100,000 sequentially from the Q3. Speaker 100:12:48R and D expenses for the 4th quarter declined approximately $700,000 from the same quarter a year ago to $5,800,000 and were down $1,300,000 sequentially. Total operating expenses for the Q4 were $42,700,000 an increase of approximately $1,400,000 from the year ago period. Operating expenses declined approximately $4,400,000 from the 3rd quarter due primarily to cost reduction initiatives in the quarter. Net loss from operations for the Q4 was $22,100,000 compared to a net loss of $13,200,000 in the same period in 2022. Our cash position as of December 31 was $40,000,000 compared to $66,400,000 at the end of 2022. Speaker 100:13:32Our cash used in the 4th quarter was $12,200,000 which compared to $38,000,000 in the previous quarter. With the $50,000,000 private placement in January, our pro form a cash position increased to $90,000,000 Last week, we also amended our credit facility with Oaktree. The milestones under which we can access the 2 remaining tranches on our debt facility, which totaled $50,000,000 were amended to allow us to access the first $25,000,000 on U. S. FDA approval of Motiva Implants and the second with the additional milestone of achieving $195,000,000 in trailing 12 month sales. Speaker 100:14:06For 2024, our guidance excludes the contribution of Motiva Implants approved in the United States. We are guiding to a revenue range of $174,000,000 to $184,000,000 representing growth of 5% to 11%. We expect currency to have a minimal impact on our sales results this year. We expect gross margins in 2024 to be approximately 100 basis points higher than 2023 to a range of 65.5% to 66%. We've taken a number of steps to lower cash use in 2024. Speaker 100:14:34Efforts include the reduction of global personnel by approximately 28%, targeted reductions in operating expenses and management of inventory levels. As a result, we expect cash used before financing in 2024 to be less than $48,000,000 With these actions, we expect to achieve positive adjusted EBITDA in 2024 and positive cash flow in 2025. I will now turn the call back to Juan Jose. Speaker 200:14:58Thank you, Raj. Establishment Labs was founded on bringing differentiated technology to an industry that has seen little innovation for decades. Unlike our competitors, we have grounded our products in true science and innovation and the clinical and scientific data clearly demonstrate our technologies have no parallel in this industry. We are now launching our technologies into China and the United States, the 2 largest highest priced and highest gross margin markets in the world. In our current markets, FluorA is constructing a new standard in breast reconstruction and Mia is creating an entirely new and higher value category in breast aesthetics. Speaker 200:15:37We are acutely focused on creating shareholder value and a significant piece of this is to get to cash flow positive as soon as possible. We are confident in our ability to do this early next year and have modeled our cash spend accordingly. With the cash we have on hand and the amendment to our credit facility, we are in an excellent position to fund our growth initiatives while meeting our profitability targets. 2024 will be one of the most important in our 20 year history. We are entering this year with a solid foundation and with a clear path to become the leading global company in breast aesthetics and reconstruction. Speaker 200:16:14I will now turn the call over to the operator for your questions. Operator00:16:19Thank Our first question is from Alan Ng with JPMorgan. Please proceed. Speaker 300:16:46Thanks for the question. Speaker 400:16:48I had a quick one to start off on China. The approval came a little bit later than expected, but you were previously expecting a contribution of in the low teens in Q4. Now some of that stocking, not all underlying quarterly demand. But how should we think about your assumptions for China contribution this year in light the fact that you're not assuming any contribution from the U. S? Speaker 100:17:16Yes. Thanks, Alan. I think when we lowered the guidance coming out of the Q3 for 2023, we talked about China being roughly $10,000,000 of the reduction in 2023. As we think about the contribution in 2024, that's a good place to start, right? We don't expect that's all going to come in the Q1. Speaker 100:17:36It should be spread out over the first 2 or 3 quarters of the year. But I think as a starting point for what China will contribute for us this year, I think that's a good place to start. Speaker 200:17:46Yes. Additionally, I think it's important to recognize that what we are doing now is holding educational events in Tier 1 and Tier 2 cities and our shipments in the first half of this year will mirror stocking taking place in those cities across China. And in the second half of the year, you should think more about some of the reordering starting to take place as demand for these procedures increase. Speaker 400:18:15Got it. And then a question kind of on broader market dynamics. When we think about the assumptions underpinning your guidance, in early January, you talked about how markets haven't necessarily recovered, but that previous weakness looks to have stabilized. What assumption do you have for the underlying market to get to your range? Should we think that the bottom half of the range assumes minimal improvement and the top half assumes more improvement? Speaker 400:18:41Just help us level set your expectations there. Thank you. Speaker 100:18:46Yes. No, I think, the way we think about it is, I think you're right. I mean, we are seeing the market stabilizing. We're seeing recovery in these markets. Things are not fully back to normal. Speaker 100:18:56I think as we look out over the course of the year and even some of the feedback we're already getting from the market is that things are picking up, things are improving. And so we do expect to see that stabilization to take hold over the year. In terms of the range, the top to the bottom, I mean, for us this year, I think as you described it, right, if we see a stronger recovery, a quicker recovery, it will probably push us towards the upper end. If things take a little bit longer, perhaps with the lower end. So we're starting this year, I think, from a kind of a conservative starting point. Speaker 100:19:27And again, we're seeing things improve out there, but it's going to take some time. Operator00:19:39Our next question is from Joanne Wuensch with Citi. Please proceed. Speaker 500:19:46Good evening and thank you for taking the question. One is sort of mechanical. I'm curious what you think your CapEx spend will be this year with the majority of your new facility behind you? And then my second question is a little bit more interesting, I hope, which is if you're seeing stabilization in demand, is it pocketed? Is it in certain regions? Speaker 500:20:08How do we think about stabilization transitioning towards higher demand and or growth? Thank you. Speaker 200:20:17Yes. Thank you for that. I think what takes us to this comments around markets recovering and us seeing some of the stabilization taking place, we see this happening at different speed in different regions. For instance, Brazil, I think it's still not in the right place, but we see Asia picking up again. We also see in our direct markets in Europe, demand picking up as well. Speaker 200:20:46So I think it's not going to happen all at once. But we're not the only company seeing the recovery in aesthetics. And that includes, of course, breast aesthetics and reconstruction. Speaker 100:20:57Yes. And on your question on CapEx, we did see stronger or heavier CapEx over the last couple of years as we were completing the new facility in Costa Rica, which you've been to. As we look out in 2024, there still is some work to be done on that facility. We also, as we've noted, we are investing in the United States. And so I think CapEx for us will still be something in the order of about $20,000,000 That's captured in the guidance we've given of the overall cash use being less than $48,000,000 this year. Speaker 500:21:27Thank you. Operator00:21:31Our next question is from Anthony Pettone with Mizuho Group. Please proceed. Anthony, your line is live. Please check if you're muted. Our next question is from Josh Jennings with TD Cowen. Operator00:21:57Please proceed. Speaker 600:22:00Hi, good afternoon. Thanks for taking the questions. I was hoping to just get some comments on Jose on your views on the state of the U. S. Breast implant market. Speaker 600:22:10I know you guys haven't launched yet, but future competitor announced or filed for bankruptcy and it seems like an opportune time for SABLXMLB to launch Motiva in the coming months. So maybe just the state of affairs there. And does this change your strategy on the U. S. Fluoro launch? Speaker 600:22:30I think Accenture had a relatively strong recon franchise. Speaker 200:22:37Yes, thanks Josh. So in the U. S. Market what you see is about 95% of procedures take place with round smooth implants that have very little difference between them. And with nothing to separate the offerings in the market, the basis of competition is not on the merits of the technology. Speaker 200:22:58So it's not surprising that in that situation the smallest of company was not able to survive. But I think that probably the slowdown in statics overall probably exacerbated the demise of that company. But overall, I think that just like any other slowdown that we have seen in the past, eventually it goes back. In 2008, 2009, it was about around 10% of procedures affected for 2 years, but eventually it came back and then came back higher. I think the U. Speaker 200:23:36S. Market is starting to pick up again from what we hear from different indicators. And yes, of course, as we look into the expansion of FLAURA, this provides for an opportunity for us to be able to bring our fully differentiated tissue expander to U. S. Centers of Excellence. Speaker 600:24:04Great, thanks. And then just I know you haven't detailed and it's a little bit premature to detail the U. S. Commercial launch strategy. But just in terms of the initial spend, the investments that have already been made versus the investments that are required as you move closer to launch and then execute the launch and just considering the updated status of your balance sheet. Speaker 600:24:26Anything you can share just on terms of investments made versus investments to be made in the coming months in front of the launch? Thanks a lot. Speaker 100:24:36Yes, sure. We have been investing in the U. S. I think as we've been building the infrastructure here to be a commercial organization, if you think about finance, logistics, the things you need to be commercial, so that spending has been taking place and we're actually leveraging that now as we've launched Fluor in the United States and are starting to see traction with that product. When we get closer to the approval of the implants in the United States, we will start to see a pickup in spending relative to commercial activity. Speaker 100:25:04But given the higher ASPs in the U. S, the higher margin here, the ability we have to leverage the spending, we've already done as well as the infrastructure we have outside the United States, the period of time which we're loss making in the U. S. Should be relatively short. I think as we noted in the prepared remarks, the amendment to the Oaktree facility also gives us additional capital should we need it to fully fund the U. Speaker 100:25:29S. Launch strategy. So we're feeling pretty good about where we are in terms of getting ready for being commercial with our entire portfolio in the U. S. Operator00:25:44Our next question is from George sellers with Stephens Incorporated. Please proceed. Speaker 700:25:50Good afternoon and thanks for taking the question. 2 parter here on Flora. Just curious, first of all, what your guidance assumes, if any, for Flora contribution in 2024? And then could you also just speak to the commercial process for Flora and breast reconstruction in the hospital as compared to commercialization in the breast augmentation market? Speaker 200:26:16Yes. Thanks, George. When you launch products, especially products that have such differentiation, a lot of your focus at the beginning is on the qualitative part. Still you heard our numbers, we have 15 centers that are working through the VAC process. That process takes time, but you're already seeing us getting into these hospitals in the first half of this year and we'll continue adding to that. Speaker 200:26:51But it's early on to be able to give you precision on what we expect for FLORA. Now overall, it is $180,000,000 market and we are selling our tissue expand at our premium. So we do expect this to eventually be an important contributor over the next few years to our growth. And definitely, it has the highest ASPs in the world and the highest gross margins for any market for tissue expanders. Speaker 700:27:23Okay. That's really helpful. And then maybe shifting to EMEA. Could you give some additional color on what EMEA contributed in the quarter? And then also your expectations, I believe you've said there's another 30 or so potential clinics that you may add to the MIA clinics. Speaker 700:27:43But just curious your expectations for that progression in 2024 as well? Speaker 200:27:49Look, just like everyone, we are super excited with MIA, particularly because we see the amazing results and the differentiated experience. The fact that these women are just going back to their daily lives minus the exercise the same day is just an amazing thing to see. And that's why we're so confident on the growth of MIA. But just like I said before, when you're launching these type of products, you focus first on the qualitative. What we did today though is give you a lot of color on the number of centers. Speaker 200:28:22So just with the list we provided, it seems that we should be in about 70 centers this year at least. So the network of NIA certified centers is increasing and what we are seeing is in the first group of clinics that launched in the second half of last year, we are seeing increasing demand every month. And as we get through capillarity in these cities with more centers getting there, then we're going to see more demand. So, eventually, I think what we will try to do is on top of all the information we gave today on the number of centers is also give you an idea in the future of how that ramps up in terms of a number of procedures. But still a little bit early to go ahead in that and do that. Speaker 700:29:16Okay. Thank you all for the time. Operator00:29:20Our next question is from Marie Thibault with BTIG. Please proceed. Speaker 300:29:26Hey, good afternoon, everyone. This is Sam Ivar on for Marie. Thanks for taking the questions. Maybe I can start, Raj, on just an operating expense question and maybe your thoughts for 2024. And if any of these cuts that you made in the back half of last year, is there anything left to be recognized in Q1? Speaker 300:29:45Is that all behind us at this point? Speaker 100:29:50Yes. So I think there will be some additional spending in the Q1 relative to the Q4 in terms of cash use, again around severance costs and we do have heavier costs usually in the beginning of the year. And I think it's also important to note that we're continuing to look for efficiencies across the business, right. So in terms of getting to the stable position, we're not there yet and we will continue to look again at ways to make our business more efficient. We did take a lot of cost out of the base. Speaker 100:30:20So if you look at operating expenses last year versus this year, they will be down something around $25,000,000 or $30,000,000 from where we were in 2023. So I don't know if that answers your question, but in terms of cash use, we could see a little bit of a tick up in the Q1 again on some of the severance costs and the restructuring costs we've undertaken. Then over the course of the year, the overall expense base is going to be significantly lower than where it was last year. Speaker 300:30:43Yes. No, that's super helpful. Thanks for that. Maybe I can use just my follow-up here. I know we're getting close to maybe when we'd expect you guys to have maybe 4 year data from the pivotal trial. Speaker 300:30:57I know considering a lot of the back and forth with the FDA right now, I don't know if that's something you're looking to present or is that something maybe we should hold off on maybe seeing you guys present until you get approval? Speaker 200:31:11So, it is important to remember that the FDA per the guidance document on breast implant requires 3 year data which we have provided. However, as a woman's health company we're always been super transparent with data. We were the 1st company ever to provide data pre approval on the trial and we will continue to do so. So yes, the idea is to provide the 4 year data to the market after the FDA has received that data for our periodic interactions. And yes, and I think this data will show as it has shown in the past that we have an amazing technology with superior safety results. Speaker 300:32:02Great. Thanks for taking the questions. Operator00:32:12Our next question is from Anthony Petrone with Mizuho Group. Please proceed. Speaker 800:32:18Thanks. Apologies, just hopping between calls here. So maybe first just on the geographic sort of split for the aesthetics market. Are there any regions where you're starting to see green shoots where perhaps distributors are seeing more activity on the ground and are re upping on inventory stocking. So that would be question 1, just geographically how the market is playing out. Speaker 800:32:43And then maybe any thoughts on where the underlying aesthetic market is in the United States just ahead of a potential launch on Motiva into the second half? And then I'll have one follow-up for Raj on the middle of the P and L. Speaker 200:32:58Yes. So if you want to think about it by regions, I think that probably Latin America and most importantly Brazil have not recovered as quickly as other markets like in Asia we're starting to see that's a full distributor region for us by the way, but we're starting to see some of the activity coming back. And we are also seeing that across Europe and especially in our direct markets where we see that in real time. So we expect this to continue taking place at different speeds in these regions. But when we think about guidance for this year, I think what you should think of is conditions improving throughout this year. Speaker 200:33:42And the U. S. Was actually hit quite strongly by this global slowdown in aesthetics. But from different indicators, we know the situation is improving. And by the time we go to market, I think that we'll be in a good position to take over demand. Speaker 200:34:02And the fact that we might go to market with one less competitor, of course, adds up to the opportunity. Speaker 800:34:10No, absolutely. And then, Raj, just on the expense outlook, when you think about the Motiva trial eventually rolling off, I mean, what is the cost burden on the trial itself? And then when you think about reinvesting those dollars, is that happening now ahead of a launch or will it happen post FDA clearance? Thanks. Speaker 100:34:31Yes, it's a fair question. We are still incurring costs relative to that trial as we're moving to the FDA process. We were getting close to the approval, but there's still costs associated with it. Once the approval happens, that's we don't stop our clinical activity in the United States. We have products coming after that. Speaker 100:34:52Mia is an important one that will come to the United States, the Ergonomix II platform. So there will still continue to be costs associated with our regulatory activity in the United States. But I think in general, as we noted earlier, we've taken quite a bit of cost out of our base here in 2024. And so again, we're operating on a much more efficient basis and it does give us some flexibility as we move through the year to take advantage of some of these opportunities if we can. So I wouldn't expect that event of the U. Speaker 100:35:22S. Approval is really going to step down our spending here too dramatically. Speaker 800:35:28Helpful. Thank you. Operator00:35:35That is all the time that we have for questions today. I will now turn the call back over to Juan Jose for closing remarks. Speaker 200:35:43Thank you for joining us in today's call. We look forward to providing our next quarterly update in May, and we wish everyone continued good health and happiness. Operator00:35:53Thank you. This will conclude today's conference. You may disconnect your lines at this time and thank you for your participation.Read moreRemove AdsPowered by