Establishment Labs Holdings Inc. (ESTA)
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May 11, 2026, 10:36 AM EDT - Market open
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J.P. Morgan 42nd Annual Healthcare Conference 2024

Jan 10, 2024

Allen Gong
VP, JPMorgan

Okay, I think we're gonna get in. Thanks, everyone, for being here today. My name's Allen Gong. I'm on the Medical Supplies and Devices team here at J.P. Morgan. I'm really excited to be introducing Establishment Labs. We're gonna start off with prepared remarks from CEO, Juan José Chacón-Quirós, and then we're gonna move on to Q&A, where Raj Denhoy, CFO, will be joining us as well.

Juan José Chacón-Quirós
CEO, Establishment Labs

Thank you, Allen, and very happy to be here at this conference. We're going to do an update on Establishment Labs and the outlook for 2024. One of the important things for people that don't know well our story is who we are. So we are a medical technology company that is focusing on transforming breast aesthetics and breast reconstruction, with this view that what was missing was a woman's health angle. This is fundamental when you think about everything that we do at Establishment Labs and also the choices that we make, the things that we choose not to do as well. We're a global company. You know, we have.

Our headquarters are based in Costa Rica, where we have our manufacturing facilities, and we are also present directly in several countries, Brazil and Argentina, with a distribution center in Brazil. In Europe, we have direct presence in the five biggest markets in Scandinavia, with a distribution center for EMEA and Asia Pacific in Belgium. Now we are setting our footprint in the United States, with our main offices in Texas, and, you know, as we begin our commercial roll-up, then we will begin adding sales reps all over the country. In terms of, you know, the market, the market for breast implants and tissue expanders is about, you know, $2-2.2 billion. Of that, around $1.5 billion comes from breast aesthetics and around $600 million from breast reconstruction.

What this industry has had, or at least the legacy of this industry, is this lack of innovation that you got from two very large players who were focused on being market leaders but did not renew their product offerings, and as a result, has had safety concerns and problems with regulators. Of course, that has led to slowly growing markets, and definitely there's an opportunity to renew the way these devices are marketed to be able to expand the markets. In our case, you know, we've been 13 years in the market. We have more than three million devices that have been placed. If you look at our results from our post-market surveillance and also the confirmation that we got from the three-year results in our Motiva U.S. IDE study, is that you get less than 1% device-related complications.

The most common device-related complications in this field is rupture of the implant and also capsular contracture, which basically is the body's reaction to this foreign object. We have many patents across, you know, our different technologies that are protecting us from our competitors. Our growth story is basically, you know, I usually think about it in, like, three different ways. You know, there's this idea that we are healing, you know, the legacy of this industry through the technology that we are bringing to market, and that has got to help expand markets. If these devices are considered safe, then more women would be looking to get them. The number one search in Google for breast implants is, "Are breast implants safe?" Tells you a lot about the legacy of this industry.

But then there's, you know, the view that if we can do, you know, a safe device, eventually what you need is to normalize access to, you know, this indication. And this is what we are doing with our minimally invasive offerings and what we are doing with creating a new category within breast aesthetics, which has, you know, the opportunity to expand markets. And then after that, in breast reconstruction, we talk a lot about democratizing access to breast reconstruction. In the U.S., access to breast reconstruction is widely available, especially to, you know, to white women. There's a lot of work to be done in Black and Latino communities, but, you know, outside of the U.S., even in Europe, it's only, like, 30%-40% of women that actually go for a breast reconstruction after breast cancer.

If you look beyond that, in Latin America, you know, for instance, in Brazil, you have waiting timelines up to 8-10 years for a breast reconstruction. In Asia and many other places, you also have a lot of challenges in terms of the access to breast reconstruction. So with our program of aesthetic breast recon, we think we can solve a lot of that. If you look at our portfolio, you know, beyond our breast reconstruction technology, which we have now included our tissue expander, Flora, what you can think about is, you know, our breast implants are, you know, all sharing the same safety profile.

We don't make people pay more for safety, but the design of our implants, when you move from a round to our Ergonomix, to our second generation of Ergonomix or to our minimally invasive, the idea is that women are empowered through, you know, education on these options to make choices. And these choices often bring them to upgrade from what used to be a commodity market, in which everyone was saying, "I'll just use the cheapest device," to actually devices that bring about different levels of benefits. And this is fundamental when we think also about the pricing. With our round implant, we're always going to be competitive, but then our job is to teach women about the options, and then they often decide to upgrade.

If you look at our revenue, you know, for the last few years, you know, we're definitely a growth story across the board. We hit a, you know, rough patch during the pandemic, just like many other companies, and then last year, in the second half of the year, just like other aesthetic companies, we were, you know, dealing with a softening demand in the aesthetic market, which also affected the breast aesthetics market. So, you know, what did we do about it? Well, starting in September and all the way through December, we engaged in this very strong reorganization for healthy growth in the company. We let go almost 25% of our workforce.

We closed programs that were nice to have, and by eliminating those programs and also, streamlining all of our back office and support functions, we are able to get into this position in which now, as we grow, we are able to get to this healthy growth. Most importantly, we didn't touch one head when it comes to commercial. All of those stay there because the focus is on growth. So, you know, our target is to be EBITDA positive by the end of this year and cash flow positive in 2025. And most importantly, I think, is that, you know, when you think about all the opportunities that are coming ahead of us, they come ahead with higher gross margins, and I'll explain a little bit more about that later.

So, for Q4, we had revenue in $31.4 million-$31.8 million. This is unaudited and preliminary. It came just in line with what we have guided to. And, cash use before our financing in, you know, it was reduced to $12.9 million in 4Q. We just did a private placement of $50 million, and that brings our cash to $89 million. And I think it's important to realize that, you know, that was something that was necessary for us to engage in so that we can focus now on the growth opportunities. So we have seen an improvement in the expectations in our market, and I'll divide that between two areas.

In direct markets, we have seen, you know, from our discussions with clinics and plastic surgeons, that they are seeing more patients coming through their doors, and they have seen a diminishing of the postponement of procedures that they saw, you know, in September, October, especially when that peaked in terms of the affectation to the aesthetic markets in breast. In terms of our distributors, you know, I think we went through a period of destocking in 3Q and 4Q, and now with the visibility that we have towards, you know, this quarter, we feel comfortable that, you know, we are going to see the patterns of ordering from our distributor normalizing in Q1 and Q2.

Now, when we think about new engines of growth, and I think this is fundamental to us, is that, you know, we have all these things that are coming ahead of us. We have, you know, the launch of Motiva in China in January of this year. So this is going to happen, actually, beginning next week, with our first activity taking place in Hainan. And after that, you know, you're going to see us participating in many other launch activities throughout this month. It's gonna have the highest distributor average selling price and the highest distributor gross margin, and that is fundamental in this. The breast augmentation market in China actually hit a low during the pandemic.

After that, it's starting to recover in a, I would say, difficult macroeconomic environment in China, but it is, you know, expected to come back to pre-pandemic levels by the end of 2025, and that's about 150,000 procedures per year in China across all market segments. When we think about the market segments in which we are going to play, those are the mid-end, premium, and luxury, you know, targets. And in that, when you think about, like, dollar terms, we're talking about, you know, this is about 70% of the total market. There are local players, so five local players in China, and they play in this, you know, lesser value market segments.

Most importantly, I think that when we did all these, you know, market research from consumers, is that, you know, 78% of Chinese women are open to breast augmentation. They say they're willing to pay more if they see higher quality options. 61% say that their families will actually support them in that choice, and this is very particular to the Chinese market. We haven't seen that in other places. And therefore, cost is not seen as a major obstacle for most people interested in the procedure. So when I showed that slide before of, you know, 70% being in those market segments at a higher price, it's because, you know, Chinese consumers have come to appreciate that quality is important, safety is important, and they see these, if possible, as luxury items that they aspire to.

With regards to Mia, you know, we launched Mia in Japan in April 2023, and then we launched in several European countries in September 2023. The most important thing is that this comes at the highest pricing per patient of all of our offerings. We are creating a new category. This new category is based on this minimally invasive technology, and this is a first in breast aesthetics. If you think about, you know, 60 years of breast augmentation, it was always done in a completely different way, and I want to talk about this. So if you see in this video, what you'll see is that the way the procedure is performed is one in which you are preserving tissue. If you look at it, basically, you're using a tracker to be able to get to the, you know, breast area.

Then once you do that, you're placing a balloon to dilate the space and be able thereafter to put the implant in. The implant is, you know, placed in that space without having to use your hands at any point. It's basically, you know, a hands-free procedure. You are injecting that implant. That implant is, you know, a prefilled implant. It's a silicone gel, next generation, different chemistry, different, physics, and basically, this is how it's done. And as you can see here, this takes place in very little time. So this has never been done before in breast aesthetics. It completely changes everything. We are not using general anesthesia. These patients are awake, under light sedation, and just, you know, redraws the map for what value is in breast aesthetics.

So, you know, we have been able to prove that, you know, you can do 10 of these cases without rushing in the morning. Part of that is because the discharge time after the procedure is only 30 minutes. As you saw, you know, we're doing these procedures in less than 15 minutes, so it's very efficient for the plastic surgery clinics. One very important thing in terms of brand equity is that these clinics, you know, our partner clinics, they are paying at least $100,000 for the license. In return for that, we are providing the entire medical education certification and the practice development. As a result, these clinics are going out there talking about Mia. They're using our brand and our category. In terms of consideration time for traditional breast augmentation, it's 3-7 years.

It's a big decision. When it comes to Mia, we've been able to reduce that in this first group of clinics to 1.9 months. So that is one of the most important things here. And these consumers have a willingness to pay that is higher. So this is real market data from these first group of countries in which we are able to charge 70% more than compared to a traditional breast augmentation. At the consumer level, in this first group, 38% were not interested in traditional breast augmentation. I think that as we create more awareness and move forward, that number is going to increase. And we've been able to create a lot of, you know, super consumer audiences through our work in social media and direct to consumer.

Of course, we're using you know, new types of ways of looking at the customer satisfaction and even an NPS score, which is a first in our industry. So we kick off 2024, moving from the 12 Mia clinics that we had originally launched to six more clinics that are expected to do commercial cases in this quarter. And then throughout the rest of the year, you should see 30+ clinics starting in our distributor markets, and these are in the Middle East, Europe, and Turkey. Additionally, we have nine clinics that are in the pipeline, in direct markets in Europe, that we will see, you know, getting onboarded over the next couple of quarters.

So what that tells you is that as we expand the network of clinics, we are gonna get a lot more information on the ramp, but I can already tell you that the clinics that we have launched in, they are experiencing more cases every month. It's still early, but it is very, very promising. Now, with regards to, Flora, our tissue expander, and its launch in the United States, you know, one of the most important things, again, this one is highest average selling price tissue expander in the world. We're charging more than three times what we are charging in Europe for an equivalent device, and also with the highest, gross margin for the category.

We did our first commercial procedure a couple of weeks ago in the MD Anderson Cancer Center in Houston, and we are very happy with the way things went. They are continuing to do cases. And you know, what does you know, Flora do? It changes the standard of care. Remember, you can do MRIs with this technology because you don't have a magnet in the port of the tissue expander. We're using our proprietary RFID technology. And because of this, also in the future, you're able to do proton therapy. And then proton really changes the game with this. That is MRI-guided, and that is why you can only do it with our tissue expander.

With proton therapy, you're really getting to be very precise with the amount of radiation therapy that you are imparting, and of course, that, you know, improves the standard of care and results. We're working towards, you know, our approval in the United States for Motiva Implants. That would be the highest direct market, average selling price, and of course, gross margin. Just a quick overview. You know, it's about, you know, $400 million-$600 million market, depending how you're counting it. You know, an average of 365,000 breast augmentations is what's been going. It's not really growing much, and, you know, you shouldn't be surprised by that. Every single technology available in the United States dates back to the last century. And that's what, you know, we can do with our innovations in this market.

So the milestones for approval, I just want to recap what we have done so far. You know, we had the site BIMO inspections. Eight sites were inspected. It is complete and totally closed out. There's no more inspections that will happen. It's important that you understand that that's how they curate the data. They actually go to each investigational site that is chosen, and they look at every single file from every single patient, and they go through it to see if there's not a missing adverse event or no double counting. Then after that, we had our sponsor BIMO inspection, in which, you know, basically they curate all the data that we have aggregated, that it has been complete and closed out without any observations. One very important thing is that we have had the direct indication from the FDA that we will have no panel.

And I think that in terms of, you know, people thinking about this taking longer, this, you know, very much there are risks, the possibility of that, taking a lot longer than we had expected. We are waiting for the GMP inspection, but the really good thing is that we are finishing the desk review. We have answered all the questions, so we are hoping that we are getting very quickly an inspection date for us. In terms of the labeling, we already started working on that in parallel.

A draft has been submitted, and of course, you know, one of the big wins for us was that we were able to confirm what the labeling of the surface of the implant will be, which was potentially a controversial thing, and that got done when we got the 510(k) clearance of our tissue expander. We've been making progress in all modules. All answers have been given to all questions in all modules. Of course, in this market, we have an opportunity to educate and differentiate because of our technologies. As I said before, all of our competitors are using technologies that date back to the last century, and by being able to provide these new technologies, we can change the equation of value for, you know, women consumers in the United States.

So, you know, if you look at, you know, consumers today, they generally don't understand, you know, the benefits of each brand. It's really a commodity market. And we've been used to this. We've launched in 85 countries, and every time we go into, to a market, you have this commodity-like behavior, and it is our job to, you know, communicate directly with patients about those options. In most markets, we have a lot of restrictions on how we can do this. In the U.S., you can actually do it, you know, within certain rules, of course, but you can actually do a lot of that, and that is fundamental for us. When you think about the surgeons, same thing. They view all brands as undifferentiated, and that's not a surprise.

You know, think about the surface of the implants that is more widely used in the United States by all of our competitors, dates back to 1962. And that's really rare in med tech, and that's what's happening today here. So as we move forward, you know, of course, medical education is going to be important. They already know how to use smooth devices, and our, you know, job is going to be to teach them the benefits, you know, smaller incisions, the ergonomic effect, softer, like real breast tissue. And of course, you know, the fact that we can use these implants, you know, above the muscle or behind the muscle without having to have more capsular contracture. If we look at 2024 and beyond, you know, I think we're in a really good place when it comes to growth.

We have the launch of Motiva in China, the continued expansion of Mia Femtech, the launch of our tissue expander, Motiva Flora, in the United States, and of course, the approval of Motiva later in the United States. So all of that, you know, gives us conviction to be able to achieve the target of $500 million in revenue, per year. And, you know, before we had said, you know, that's gonna happen in 2026, I think what we have done now, because if it's a completely different, situation in terms of the cost of capital and, you know, everything that we have seen, is that we are adding on, on that. How we get there is as important as getting to that $500 million target, and that's why we will get there being cash flow positive.

So thank you very much, and happy to take your questions.

Allen Gong
VP, JPMorgan

Thank you for that. So, you know, just starting with the quarter, you reported sales around $31.5 million, is basically right where you're expecting, right where the street was at. You know, there clearly continued to be challenges with distributor restocking, with your end markets, but it's really encouraging to hear that that's kind of hit the trough. But just out of curiosity and to help us kind of, you know, plot the trajectory into this year, how should we think about those dynamics that you were worried about? You know, the end market softness, the distributor restocking through October, November and December.

Juan José Chacón-Quirós
CEO, Establishment Labs

So I think it's important to understand that, most likely some of the softness that you saw in the overall aesthetics market and also in the breast aesthetics market started happening in Q2. It's just that, you know, we were coming from a fast period of growth and, you know, when we started seeing it, you know, it was after the summer break. Because at that point, we realized this is not seasonality, which we usually get, and we said, "Well, this is something different." So throughout that period of malaise that we had in, you know, Q3 and Q4, I think, you know, there was a question about how long that's going to last.

You know, I think in the last part of the quarter, we started realizing that there was, you know, a change in sentiment from the different practices, and that gives us, you know, a lot of confidence in what we are seeing. We think Q1 is going to be sequentially higher than last quarter, and also, we do expect a resumption of, you know, many of the distributors with their orders this quarter and into next quarter at different speeds, but this is going to start happening more and more.

Allen Gong
VP, JPMorgan

So yeah, I guess because of that distributor dynamic, correct me if I'm wrong here, but I believe, you know, we can think of it as kind of like maybe a 6-8-month, 6-8-month inventory cycle. You know, normally it's not all just one bolus restocking, but because of the significant dynamic that we've seen this year, which would we say that, you know, like we're set up to have a pretty strong first half because of that, and then the back half might see a bit more of that market recovery, so it might be a little bit more ratable over the year?

Raj Denhoy
CFO, Establishment Labs

Yeah, I think as we've looked at, you know, our own internal data about where our distributors sit in terms of the inventory that they have and what we've sold into them, what we think they've sold out, you know, we are through the worst of the destocking. You know, the pace at which they come back, as Juan José was noting, is a little bit unknowable, right? We have a number of distributors globally, but when we look at that data, it suggests that they're getting to the point where their inventory levels suggest they have to start coming back. But I think beyond that, as we look at the orders we're already getting here in the Q1, we're actually seeing that demand already return.

So as Juan José mentioned, I think we have seen the worst of this, and we do expect a recovery over 2024. Again, the pace of that is a little bit, you know, give us a little time to see how it plays out, but so far, we're seeing a nice resumption.

Allen Gong
VP, JPMorgan

I don't want to get ahead of myself, but I think when you talked about the end market softness, you said they were down maybe like 10%-20%, depending on the geography, and that you were actually outperforming that with, you know, Motiva seeing declines more in the single digits. So when I think about markets, you know, hopefully beginning to recover and, you know, everyone trying to kind of recapture that lost share, is that something that you could kind of see maybe an outsized benefit of and maybe take advantage of to kind of go after those, you know, those accounts that, you know, stopped using as many implants because of this shortfall?

Juan José Chacón-Quirós
CEO, Establishment Labs

I think there's, you know, there's some of that. And also, when we think about, like, what we see in the market, is that when the distributors started destocking, then in a place like APAC, you know, it came down in the Q3 by 80%. Was the market down by 80% in Asia? Well, no. So it had this amplification of the effect of the market softness. So as it comes back, I think we'll also see an amplification on the positive side. Overall, you know, our view is that, you know, this year we're going to be able to gain new accounts through like initiatives like Mia.

You know, the most important clinic in Madrid that used to be in a competitor account, basically, is moving to all of Motiva, the entire portfolio, because of Mia, because they see it as a future. When you think about the, you know, approval of Motiva in the United States, it's going to have a halo effect, you know, in the rest of the world, because there's still a group of clinics and plastic surgeons, it's not small, that say, "I only use FDA-approved products," and they use that as a badge of honor. So once we get the approval, we're going to go and target all of those accounts. So there's many opportunities, I think, this year to be able to capture market share beyond these new engines of growth that we've been talking about.

Allen Gong
VP, JPMorgan

So one of the big opportunities for you that you highlighted is going to be China, right? You, you took China out of, you know, the Q4 because of the timing of the approval. It came right after your earnings report. So how should we think about the contribution from China this year? Because the, the numbers that you gave us imply that roughly, you know, a little over $10 million of sales came out of Q4 because that initial stocking order wasn't going to make it in time. Should we think of that as something that, you know, is on track for Q1, and then we should think of, you know, kind of normal distributor, stocking, destocking dynamics after that?

Raj Denhoy
CFO, Establishment Labs

Yes, so I think, just a little more context. You know, that $10 million or so of stocking we expected in 2023 was really in the second half of the year. And so when one thinks about how that will play out now in 2024, I would think about it over that period as well. Don't expect it all to come in the Q1. We are shipping product. You know, there is... That activity is picking up in China. As Juan José noted, you know, the launch is coming up in the next few days there.

But really think about that stocking to take place over the first couple of quarters, and then as we move into the back half of the year, you'll start to see reordering from that distributor and as they continue to expand as well.

Allen Gong
VP, JPMorgan

So the distributor you're using in China is the same one that you've used to pretty great success in South Korea, I believe. You know, similar in the fact that they're in APAC, but how should we think about, you know, any potential differences, any potential challenges, whether it's just, you know, the end user or the competitive landscape? Just to kind of give us a little bit more nuance to how, you know, the China launch. Like, you know, I guess, how quickly can you get to, like, majority share in China like you did in South Korea?

Juan José Chacón-Quirós
CEO, Establishment Labs

Well, I think, you know, one of the most important things is that, you know, for Chinese consumers, you know, they define their aesthetic aspirations through what is happening in South Korea. South Korea has been extremely successful, you know, in becoming the pioneer in many of the trends that you see in aesthetics, and breast aesthetics is, you know, is no different. Before the pandemic, you know, 25% of patients getting Motiva in South Korea came from China. There's already good awareness of Motiva in Chinese consumers, and we've had similar comments from, you know, our partners in Japan, in Thailand, and even Vietnam. So what that tells you is that when they think about, you know, Motiva, they see, you know, the market leadership in South Korea as a very important factor.

More than that, one of the things that our partner has done in South Korea is create this view that this is a luxury item. They've been able to communicate with consumers in a very effective way, and in that, you know, in that market, they've been able to take over 60% of it. If you look at every single market in Asia, it's been this exercise of going in there. Usually, you know, market leader has been the J&J Mentor brands and us in a period of 3-4 years, gaining market leadership.... And we think that, you know, the way the launch has been prepared for China gives us the opportunity to follow a similar pattern. And, you know, if anything, we think that the particularities of the Chinese market make it even better for us to be able to be successful.

Allen Gong
VP, JPMorgan

Pivoting away from China to the U.S., kind of, you know, those are your two biggest opportunity, like, single biggest opportunities from a geographic standpoint going forwards. You know, you just talked about how you're really hoping to be able to, you know, convert the majority of China within, you know, a few years. You know, U.S., a little bit different. It's been, you know, dominated by two players for quite a while. You know, hopefully, we'll get the approval, you know, later this year as planned. But how should we think about your ability to kind of, you know, take off running, you know, here as a direct market, where you haven't really been able to, you know, directly sell or market your product ahead of the FDA approval?

Juan José Chacón-Quirós
CEO, Establishment Labs

Yeah, I think, you know, when we've been launching, you know, in so many different geographies, price-sensitive countries, sophisticated markets, and, you know, we see similar situations. You know, when we arrive, it tends to be a commodity market. Surgeons don't see any differentiation and, you know, any reason to pay more. But we see two things that really, you know, come in our favor. One is the percentage of plastic surgeons who are used to smooth devices, because in markets where they are mostly textured users, we need to do all of that work of doing the medical education to teach them how to properly use our devices, and that takes time, and it takes resources.

In the U.S., all plastic surgeons know how to use smooth devices, so job is going to be more about teaching them the additional benefits, like, you know, smaller incisions, you know, pre-pectoral placement of the implant, you know, the softer results that you get with it. So that gives us a possibility to speed adoption with, you know, less resources than we have done in other markets. And then additionally, the other thing that tends to speed our adoption is, you know, us speaking directly to consumers ahead of them visiting a plastic surgeon. And most markets have a lot of restrictions. In the U.S., you can actually do this effectively within a certain set of rules.

So those two things, you know, give us comfort that, you know, we're going to be able to use all of our assets when it comes to taking market share. On the other hand, it is true, you know, these are the two largest markets for the, you know, J&J brands and Allergan Aesthetics, so they're going to fight for it. But, we have, I think, a very good understanding of what gets us there, and, definitely, we're setting the stage. We've been preparing already, you know, since last year, where we've been setting all the commercial operations. You know, already, you know, we've been, you know, with the tissue expander, beginning to invoice to, you know, get the, logistics going. So all of that preparation are taking place already.

Allen Gong
VP, JPMorgan

So you've already given us quite a few updates on the FDA process, so I don't want to push too hard here, but, you know, we all understand that that process can be pretty opaque. Funny enough, all right, after this, we're actually having kind of like an FDA panel to get some insight into the approval process. But, you know, it's really encouraging to hear that you know, you're not going to need a panel and that you are, you know, really knocking down the final pins and that you do expect in 2024. I'm assuming there isn't anything, but is there anything you can, like, you know, say directionally about timelines?

You know, when you do get that manufacturing inspection complete, is that something that you will, you know, make public, or is it just going to be kind of head down until you get the approval?

Raj Denhoy
CFO, Establishment Labs

You know, I think generally, we've tried to be very respectful of the FDA process, right? To let the FDA, you know, do their work and do everything they need to do to get approval. And as you noted, I think our confidence only continues to grow that that approval is coming this year. You know, we've also tried to, you know, not put a timeline, a specific timeline, to create expectation around when that will occur. And we'll likely continue to communicate in that fashion. So in ordinary courses of events like this or on our earnings calls, we'll provide updates as necessary. But again, everything's moving along, and we're just going to let it run its course.

Allen Gong
VP, JPMorgan

So you did get the approval for Flora. You just performed your first case in the U.S. You know, big market opportunity. So I just have a few questions on, you know, we have the data for Motiva clearly being very differentiated against the offerings on the market today. How should we think about, you know, physician views on the differentiation of Flora? And, you know, frankly, how easily is that sale for your sales force without the Motiva implant to go with it ahead of the approval?

Juan José Chacón-Quirós
CEO, Establishment Labs

Yeah, I think the most important thing to realize is that not only do we have the benefit of our RFID port, the fact that you don't have magnets, the fact that you don't have any metal pieces, creates, like, binary differentiation just right there. You know, a woman today that needs an MRI during the expansion process of a breast reconstruction after breast cancer would have to take that device out, and that is important. Because of the metal and the magnets, they have to give higher doses of radiation therapy, sometimes touching the lung and the heart. That is a binary benefit of our technology. And on top of that, you have the surface technology, which, by the way, it's shared with our breast implant.

So it gives us the ability to talk about our, you know, surface technology, which is one of our biggest benefits. And, when you think about, like, the importance in breast reconstruction of the genesis of that first capsule that is created around the tissue expander, with our type of surface, you get a very healthy capsule, and that is important. Because then, after that, you know, of course, we're not going to have the approval for breast reconstruction immediately, but as, you know, they make their choices, they know that that first capsule that was created is a healthy capsule, and that's going to, of course, help in our targeting of the different centers of excellence that we're going to be using at first.

Allen Gong
VP, JPMorgan

I want to touch on Mia, and then, you know, touch on, on the financials in the kind of final minutes we have left. But Mia could be a really, really differentiated offering in this space. You know, you're charging a premium commensurate with that. You know, based on your early experience so far with these, you know, very specific clinics, very specific partners, has, you know, has price ever come up as a concern? Or is it just, you know, that this is such a unique, differentiated offering that's kind of, you know, starting to expand the market, that they're willing to kind of pay a premium for it?

Juan José Chacón-Quirós
CEO, Establishment Labs

So of course, that has been one of our concerns all along, but we performed enough market research and most importantly, willingness to pay, you know, research, so to that we understood what the right pricing was. And not just the pricing of the final procedure, but our pricing, you know, to these partners. So if you think about many of these clinics, you know, if they are charging 70% more in average for a Mia procedure compared to a traditional breast augmentation, of course, they see that as a big positive for them. And more importantly, you know, the efficiency of this technique. I mean, you saw the video. It takes place in very little time, quick discharge. The scalpel never touches that breast, so as a result, you get a quick recovery.

These women are going back to their daily lives very quickly, and that creates word of mouth, and that is going to be, you know, a positive for all of them. So, you know, we'll continue monitoring, and we'll continue seeing what happens, you know, in all of these clinics. But so far, I think it's a very positive attitude to the value proposition as a whole.

Allen Gong
VP, JPMorgan

Then closing out the final minutes with some of the financials. You know, you've laid out and reiterated your plan to hit EBITDA profitability before the end of the year, and then cash flow profitability by the end of next year. You know, I think my concern is that you're in this really exciting growth phase of the company. You know, you've talked about how you haven't cut any revenue-generating functions. But, like, let's say you get the U.S. approval. Let's say, you know, so your end markets start recovering, and you want to get back and get really aggressive. How confident are you that you can, you know, fully take advantage of those opportunities while still continuing to rationalize and leverage?

Raj Denhoy
CFO, Establishment Labs

Yeah, it's a fair question. I mean, I think if you saw the cash use in the Q4, and you've, you know, we've talked a lot about the really structural changes we made, really starting in September around, you know, letting go about 24%-25% of the company. You know, granted, a lot of those were in manufacturing, but some cuts across the organization. You know, we've made a lot of changes, right? And we were building for perhaps a different demand equation than we currently find ourselves in. And so we made reductions to match what we're spending to what we're currently seeing.

In that environment, and again, you've seen in the cash use, when we expect it's going to continue to be, you know, at that level or perhaps lower, as you look at an average use, in 2024 on a quarterly basis, you know, we've made those structural changes. And, you know, I think the goal for us is to achieve those targets in a sense, regardless of the approval processes that you described. If we're doing better, can we spend a bit more? Perhaps. But we're. Those targets are sort of sacrosanct to us. We're gonna, we're gonna achieve them. And I think it's important that we send that message to the investment community, and we continue to operate like that internally.

Allen Gong
VP, JPMorgan

Got it. Any questions from the audience? Just one final one then. You know, I don't want to get ahead of myself before we get the Motiva approval, but again, kind of touching on Mia. Once you do get the Motiva approval, how should we think about a timeline to get Mia ultimately into the U.S. as well?

Juan José Chacón-Quirós
CEO, Establishment Labs

So what our regulatory team and our external, regulatory experts think is that, the Ergonomix2 platform, which is, you know, the implant that is used in Mia, will be a supplement to the eventual approval of Motiva implants. And after that, the other ones, the tools, will be accessories to an approved device. That takes you to a timeline, being conservative, 18-24 months after, you know, the approval of the implants. But I think it's very important to say that all of our air time right now with the FDA is on the current approval, so we haven't had this discussion. I think the moment we get the approval, we're definitely going to go in there. Remember, with the Ergonomix2 platform, we can launch the JOY program and also Mia.

There's two very important things as we look forward, because all of these clinics that we are going to engage with in the United States, you know, we can also give them visibility to what's coming in the future. That's gonna make a big difference when you're trying to sell technology and innovation to a market that has been commoditized.

Allen Gong
VP, JPMorgan

I'll be sure to bother the FDA when I see them in the next session. Thank you both for coming today, and thank all of you for your time.

Juan José Chacón-Quirós
CEO, Establishment Labs

Thank you.

Raj Denhoy
CFO, Establishment Labs

Thank you, Allen. Thank you.

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