Okay, let me kick off our first session here this morning. I'm Matt Taylor, the U.S. Medical Supplies and Devices Analyst here at Jefferies. Kick it off the Jefferies Morning Radio show here in London with my friend Juan José Chacón-Quirós. He's the CEO and Founder of Establishment Labs, which is a name that we like very much. Juan José , to start, I want to give you a high-level question, get everybody warmed up. For those in the audience unfamiliar with your offerings, could you just highlight some of the key advantages that you have with the Motiva technology, the MIA technology, and talk about how you're trying to revolutionize women's health?
Yeah, I think, you know, we can start by saying that, you know, what's really revolutionary is to have a women's health company dedicated to the space of breast aesthetics and breast reconstruction. And what we've done, you know, since, you know, the founding of our company 20 years ago is to dedicate our R&D to transforming the entire, you know, technology framework in breast implants. So when you think about, like, the foundation of that implant, the chemistry, the physics of it, completely different. And what you see is, you know, 14 years after going to market, four million implants out there. Because of that, we have a less than 1% rupture rate, which used to be one of the biggest reasons for reoperation. And then the other one is Capsular Contracture, you know, the body's reaction to, you know, a foreign object.
That used to be another big problem. Again, we created a proprietary patented technology called SmoothSilk, and that technology can reduce the inflammatory response. Because of that, we've again reduced that reoperation rate to less than 1%, which is an order of magnitude less than everyone else. So, you know, starting from there, everything that we've done in terms of creating ergonomic implants, minimally invasive breast augmentation, all of these things are meaningful and will create new markets.
Your calling card has been safety, and I think you've really proven that out over time with a lot of great data. But maybe talk about some of the things that you're also doing on the aesthetic side to make more options for women, to make it more of a consumer-friendly experience. Those kinds of things stand out too.
Yeah, well, I think, you know, what we set ourselves to do when we went to market in 2010 is, you know, safety first. We had to resolve those two big, important reasons for reoperations in that space. And once we got that done, dedicate ourselves to doing the things that are important to consumers. So, for instance, if you go back to 2014, when we launched our ergonomic implant, the ergonomic implant is very simple. It's just more comfortable. It moves, you know, with, you know, the body's own movement. So therefore, it is better for, you know, for women in their daily lives. And now we've taken that concept all the way to minimally invasive. And when you think about minimally invasive and the way it's revolutionized so many surgical specialties, it will have the same effect in plastic surgery.
You know, our MIA program is one that we got to market 12-18 months ago, depending on the region of the world. You know, what we've been able to prove is that there's a new consumer out there. There's more than 40% of the population of MIA patients so far in this phase of the launch that were not looking for a breast augmentation. You know, breast augmentation hasn't really grown that much, you know, worldwide. This proves that there is a need, there is a desire to have these procedures. It's just there wasn't the technology to make it happen for so many women. That's what we're proving with MIA Femtech.
Want to talk a little bit more about MIA in a second, but let's start with Motiva. And until recently, you weren't in China and the U.S., but you were in a lot of countries around the world. And what I think is really notable about your story is that you've been able to achieve success in a lot of different countries and different types of countries. So maybe talk about how you're able to capture leading market share in some of these different markets.
Yeah, I think what's underappreciated is that, you know, over the last 14 years, we have been playing really in the toughest markets with the, you know, toughest average selling prices, toughest gross margins, and still we've been able to be super successful. And it's the story of, you know, safer technology, better options for women. And that's why, you know, we've taken a commanding position in every market that we are in. And now with China and the U.S., what we are doing is really tripling our total addressable market. And, you know, as we execute on those two markets, not only do we get to the highest ASP market for distributor in the world and the highest, you know, direct market for us, which is the United States. You know, we are capturing, you know, a gross margin in the U.S.
that, you know, has already proven in this, you know, first six weeks of the launch to be, you know, the one that we need in the trajectory to bring us to profitability as a company.
You touched on MIA, which is an exciting technology. I wanted to talk about the early progress there where you've been signing up a lot of accounts in Europe. You mentioned the market expansion that that could drive. I think you've done some research showing that over 40% of some of these early consumers weren't even in the market for implantation. Maybe talk about how it's reinforcing your market expansion thesis.
Yeah, I think it's also important to give, you know, a framework to understand what new category creation really is about, so if you go back to, for instance, what Invisalign did, you know, a generation ago, year one and year two were not particularly big in terms of revenue. If you look at what CoolSculpting did, you know, starting a decade ago, year one and year two were not particularly big in terms of revenue. It was more about proving the category, and when we think about our current numbers, we are doing so much better than that, and that's because, you know, we are proving over 40% of women that have come already, you know, to get MIA were not seeking a breast augmentation. The consideration time has been going from three to seven years to less than two months.
On top of that, the willingness to pay is 30%-50% higher. Year one has been mostly about being able to prove that and looking at the trajectory of the first clinics that launch and how they are, you know, adding cases every month. That's what gives us the, you know, the conviction that in year two, which is really about expanding massively the number of clinics, getting the capillarity that we need, and that combination should get us by year three to a very good place. I think that's the type of revenue that we would like to see. We're talking about, you know, really nice gross margins and an ASP that is very healthy because surgeons and clinics are charging 30%-50% more.
So maybe we could talk about China and the U.S. a little bit more. Those are the two biggest markets in the world, and you're now happily in both in the last year. Could you talk about how things are going first in China? I'd love to hear about the early experience. And also, you announced this $50 million investment in your distributor. So I was wondering if you could talk about how that could help reinforce the value prop and really drive commercial success in China.
So if you think about the Chinese market, you know, if you take a long-term view of it, it's, you know, it's going to be one of the highest growing markets worldwide for breast aesthetics. And, you know, this year was not particularly a good year for aesthetics in China. And yet we've been able to expand our reach. We've been, you know, through our exclusive partner, Motiva China, we've been putting, you know, our product in tier one, tier two cities, engaging in medical education, really setting the foundation for growth there. I was just in China last week, and we held a big event with some of the best clinics in China participating in it, some of the most well-known and reputable Chinese plastic surgeons. And what we saw is that there's a lot of excitement about Motiva.
With the investment that our partner just got, you know, as part of an agreement with a subsidiary of CBC Group, you know, they are going to have the wherewithal to really go for the market. Currently, over 70% of that market belongs to Johnson & Johnson with their Mentor range. You know, just like we've done in all of the other Asian markets, you know, with taking market share from Johnson & Johnson, I think it's going to be similar in China. With this investment, our partner is really going to have everything they need to be able to execute on that.
In terms of the market itself, you mentioned it was kind of a rough year. Do you expect some benefit from the stimulus?
Absolutely. I mean, already, you know, last week when I was there and talking to the clinic owners, you know, from some of the biggest cities in China, they were pretty excited about seeing, like, you know, the resurgence of market demand. Of course, you know, that takes time to transition into conversion of new surgeries. But I think, you know, everyone in China feels very strongly that, you know, next year is going to be a better year for aesthetics. And that, of course, is going to be very beneficial to us.
So let's talk about the U.S., which is the largest market. And you recently received approval. And it sounds like in the early days of the launch, things are going smashingly well. You gave a lot of stats on your last call about hiring sales reps and signing up accounts. So I was wondering if you could cover that and talk about what to expect in the U.S. next year and the next few years.
Yeah, I actually brought some updated numbers for you. So we are at more than 300 accounts onboarded. We are now at 35 sales reps. And, you know, we continue to see an overwhelming desire to participate in the Motiva story. We've had groups of surgeons continuing to come to our headquarters in Costa Rica, getting the Sulàyòm experience. We have another group actually that came just last weekend with 20 surgeons that, you know, were there for us. So it's really building up the way we wanted. In fact, it has exceeded our expectations. Of course, you know, we are always, you know, very mindful of, you know, the type of ramp that we do when we are launching in a market. But this has exceeded our expectations.
You mentioned before that, you know, China and the U.S. being premium markets and with MIA being a premium product, this is all very good for margins. It sounds like in the early days of the U.S. launch, you are starting to prove that out, that the market is willing to accept a, you know, premium price that you have done in many other markets. Just teeing up a question about your margins, can you talk about how mix could accrue to gross margins over the next few years with all of this positive mix shift and what that means for the company's profitability overall?
I think you can already see the trajectory. If you look at, you know, the numbers we just put out over last quarter compared to a year ago, how we've improved in terms of, you know, our cash flow, cash burn, OpEx, all of these things, which really shows the discipline we've had to be more efficient while at the same time increasing our average selling prices in these markets. So if you look at MIA, MIA has, you know, a gross margin that is vastly superior to what we have on average today. If you look at the U.S., same story. If you look at China, same story. So I think our gross margins will continue to trend up. I think, you know, we are being mindful of not overstating this.
But, you know, this is just a natural outcome of the type of markets that we are going in. And the good thing with the U.S. is that not only are you getting the higher gross margins, but you're getting the, you know, the numbers in terms of, you know, total implants that are sold there that are so much better for us. And, you know, we are producing our implants in Costa Rica. Our, you know, our COGS are very, very healthy, let's call it. And as a result, I think that as we go into these markets, it's going to show our road to profitability.
Related to that, you know, you took the opportunity to do a raise recently and really shore up the balance sheet with access to debt as well. Let's talk about your cash position and with a goal to be EBITDA positive by the end of the year. It seems like you're in a really good place to have some buffer and also invest.
Yeah, I got to tell you, look, we felt that we were in a good place, but we heard a concern of certain investors who, you know, wanted us to have a stronger cash position. So we went ahead with this raise. Pro forma, we're at, you know, more than $114 million. We have access to another $25 million under Oaktree Agreement for 2025. And, you know, with the reduction in the cash burn that we've had, I think this, you know, is vastly, you know, more than what we need to be able to get to profitability. So yeah, we are on our way to having our first bit of positive quarter in 2025 and definitely profitable in 2026.
Now, there's been a lot of focus on streamlining the company, and you did a reduction in force a few quarters ago. Maybe talk about how you were able to do that successfully without disrupting operations and disrupting sales.
I think, you know, like we're not the only tech company that, you know, grew fatter during the pandemic because, you know, you were trying to make up for all the inefficiencies that came about during that period, and eventually, you know, a year ago, we realized, you know, it's time to bring it to the place that it should be, and yet, if you look at the number of headcount in commercial, it has gone up 30% in the company. If you look at, you know, people within the company that are dedicated to growth, it's grown like 30%. We recently decommissioned our first facility. We had three manufacturing plants, so the one that we opened 15 years ago was just recently decommissioned, so now we're focusing manufacturing in the two other sites.
That, of course, is going to have an effect in terms of efficiency, our ability to control better those two sites. You know, I think that as we continue in this year, we will continue to, you know, promote efficiency measures while putting our money where the growth is.
I want to dig into some of the macro challenges that you've had, especially in Latin America. That did impact guidance this year. You recently lowered Q4 and talked about a 5% outlook for international for 2025. Maybe just give us some thoughts on the state of the international markets in terms of how healthy they are and the potential for growth in 2025.
Yeah, I think this is one of the key points because if you look at what happened in, you know, during the pandemic, you had a lot of people going for aesthetic procedures, perhaps many of them ahead of when they were planning to have them. And then on top of that, you had the situation where, you know, in 2023, you had high inflation and high interest rates all over the world. And that had an effect in the aesthetic consumer. So, you know, we're not the only company that has talked about this because it is real. Yet if you look at, you know, this year, we will grow in Asia-Pacific, our core business. We will grow, you know, in Europe, Middle East, and Africa, our core business. Yet, you know, there have been serious pressures across the board in those two regions.
So, you know, it shows that we're taking market share. It shows that, you know, we are continuing to do what is right to grow in this market. Now, in Latin America, I think the situation has been a little bit more dramatic, especially in Brazil. And we've been managing through it. Now, the good thing in Latin America is that I think we've seen a turning point. The situation has stabilized, is not deteriorating further. And although we are planning for, you know, for the situation to stay as it is for, you know, 2025, there is a possibility of having an upside next year. But, you know, the way we are planning for budgeting reasons, that's the way we're thinking about it.
What are the key macro factors? Is it rates or what should investors watch out for to think about whether the market could improve in 2025?
I think it's a combination of interest rates and inflation that has been damaging to the aesthetic consumer. But already you see it. Look, I was in South Korea just, you know, last week. You know, when you look at the market there, the market this year for, you know, breast procedure is going to be flat. Yet we're taking 6%, you know, market share in South Korea this year, and when you talk to surgeons, they say, look, it's really hard. You know, the Korean economy was affected by the rise in the interest rates in the U.S. You know, now their hope is that it will continue to scale back in terms of interest rates, and therefore, it will give the opportunity for the aesthetic consumer to come back, and that's the situation that we see in many different markets.
Yet we are focused in doing what's right. Remember, we're still launching products. Our Ergonomix2 platform and MIA have yet to be launched in many countries. So that's something we will be doing next year as well. So I think we have many, many interesting options for growth for 2025 beyond China and the U.S.
Sometimes I get this question from investors. When you're moving into China now and the U.S., is there anything structurally different about those markets that would make it more difficult for you to take share? Do you think it's easier for you to take share in those markets? What's the comparison that investors should use to those markets? Is South Korea the best proxy?
I think over the last few years, we've proven that we have a pretty linear road to leadership in key markets. We've proven that in, you know, South Korea, in Taiwan, in, you know, European markets as well. So I think, you know, when you look at the U.S., for instance, it's a market that has all the positives for us. Surgeons already know how to use smooth implants. Surgeons are looking for new options. They haven't had a new technology in over 20 years. And when you think about like everything that the U.S. plastic surgeon is posting on, you know, on different social media, it's all about like with this technology, I can put these implants over the muscle. Basically, I'm doing tissue preservation and I'm, you know, giving women a new possibility. And remember, these are very active women.
So not splitting their pectoralis muscle is actually quite a big thing. So these type of new options is what's going to drive our growth in the U.S., plus the amazing difference in terms of the safety rates. You know, when you look at the results of our clinical study, we are an order of magnitude less in terms of, you know, complications leading to re-operations. So all of this, I think, is going to drive our growth in the U.S. At the same time, of course, you know, for our two main competitors, it's their last bastion. You know, it's the last place where they can hold market share. So it's going to be a good fight, but I think we have everything that we need because we have the technology. And of course, you know, it's not only what we launch now.
We're going to have new product launches coming to the U.S. as well.
Another aspect of the story that doesn't get talked about as much is reconstruction, and I guess I wanted to talk about, a, the Flora tissue expander that you've launched in a number of markets now, and also the pathway to get an official approval for recon in the U.S.
Yeah, no, it's fundamental, I think, in terms of growth for the, you know, foreseeable future. You know, the growth into breast reconstruction takes longer because, you know, you have to go through different types of contracting procedures around the world. But what's really important is that that tissue expander changes, you know, protocols across the board in, you know, hospitals that are doing breast reconstruction. You know, for instance, something that surgeons have been doing for breast reconstruction in the United States, which is to wrap a tissue expander in over $10,000 of acellular dermal matrix to reduce capsular contracture. And already there are certain, you know, hospitals in the U.S. saying, I don't need to do that. So of course, it has an impact.
And then, you know, when you think about like the trial with the cohorts of reconstruction and revision reconstruction, you know, those two cohorts got delayed during the pandemic when the hospitals stopped doing breast reconstructions. But, you know, we're going to have our three-year data in, you know, after the summer next year. And with that, we're going to be able to seek the clearance. So you're not only going to see, you know, what we have now, you're going to see us going very strongly into breast reconstruction after that approval.
As far as other pipeline guideposts to look for, could you talk about A, the pathway for MIA approval in the U.S. and China? We'll start with that one.
It's very interesting because, you know, we held meetings last week with our regulatory experts in China. You know, we understand what the pathway would be in China for the approval of MIA with the NMPA. We're going to be working on that. It's really important to us when we did our global market share, I mean, market analysis for MIA. China was the number one market, followed by Europe and the U.S. closely after. We absolutely believe that, you know, China is going to be eventually a big driver for MIA. I'm not going to give exact dates, but we are absolutely looking forward to, you know, to starting that approval for MIA. In the United States, I think we've been very clear.
You know, it's a supplement for the breast implant and a different path, you know, either a 510(k) or an accessory to an approved device for the tools that are necessary for the MIA procedure.
And you sort of teased this before with you're going to be launching other products. I was wondering if you could talk about the pipeline beyond Motiva and MIA. In the past, you've mentioned things like gluteal implants. Are there other ways that you can use your technology?
Yeah, to put it into context, what we created with MIA is basically the first expression of our tissue preservation platform. So when you're doing breast tissue preservation, basically what you are doing is using minimally invasive tools to be able to deliver, you know, the desired outcome, you know, one to two cups up in the case of MIA through a very small incision in the axilla, no general anesthesia, quick recovery. And that is, you know, the entire program that we're doing with MIA. But now we are taking tissue preservation to the rest of the field. So you're going to hear us talking more and more about tissue preservation because we are using an adaptation of the MIA tools for, you know, mastopexies, revision surgeries, hybrid procedures, all of these things that are the bread and butter of these clinics.
It's going to have a big impact. And finally, GEM, Gluteal Ergonomic Modeling. That's an indication, 800,000 procedures a year, really bad options for women worldwide, yet a lot of interest in it. And what we are doing is leveraging our minimally invasive platform to be able to do that in less than 20 minutes with no general anesthesia and a quick recovery. And of course, the safety that you need. Those things will have an impact. And just to remind everyone, all of these are organic, you know, programs that we are doing at Establishment Labs.
Last question. What are the guideposts that we should look for on the GEM program? What will we be hearing about?
So we finished our first study already. So I think, you know, the data from the first study will be very interesting. And we are in our second study. So we hope to fully enroll and finish that trial in the next couple of months. So I think in 2025, you'll hear us talking more and more about GEM because it is super exciting technology.
Fantastic. Well, Juan José, thanks so much for your time. And thanks everybody for your interest in Establishment Labs.
Thank you.