Establishment Labs - Q3 2024

Transcript

Operator (participant)

Good afternoon. Welcome to Establishment Labs' third quarter 2024 Earnings Conference 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, and instructions will follow at that time. As a reminder, today's call is being recorded. I will now turn the call over to your host, Raj Denhoy, Chief Financial Officer. Please go ahead.

Raj Denhoy (CFO)

Thank you, Operator, and thank you, everyone, for joining us. With me today is Juan José Chacón-Quirós, 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. These include statements on Establishment Labs' financial outlook and the company's plans and timing for product development and sales. These forward-looking statements are based on management's current expectations and involve risks and uncertainties. For discussion of the principal risk factors and uncertainties that may affect our performance or cause actual results to differ materially from these statements, I encourage you to review our most recent annual and quarterly reports on Form 10-K 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 profitability of the company's business, which can be stated as EBITDA or adjusted EBITDA. Reconciliations to comparable GAAP financial measures for non-GAAP measures, if available, may be found in today's press release, which is available on our website. The content of this conference call contains time-sensitive information accurate only as of the date of this live broadcast, November 7th, 2024. Except as required by law, Establishment Labs undertakes no obligation to revise or otherwise update any statements to reflect events or circumstances as of the date of this call. With that, it is my pleasure to turn the call over to our CEO, Juan José.

Juan Chacón-Quirós (CEO)

Thank you, Raj, and good afternoon, everyone. The approval of Motiva Implants on September 26th was a watershed moment for our company and for the plastic surgery industry. The launch has exceeded even our high expectations. The pace at which we are onboarding new accounts and the orders we are seeing validates what we have shown in many other countries around the world: that safer and better technology that offers new options can move markets. I'll provide some additional details in a moment. With the launch in the United States going so well, we have taken this opportunity to strengthen our balance sheet. Following FDA approval, we accessed $25 million under our existing credit facility. Today, we are also announcing that we have completed a registered direct offering to invest $50 million at a 5% discount to our closing price.

This equity raise was done in conjunction with an amendment to the Oaktree credit facility, where we can now access the remaining $25 million until the end of 2025. With the capital infusion, our pro forma cash position at the end of the third quarter was $114 million, and with the amendment, we have access to an additional $25 million through the end of next year. This will allow us to fully invest in our U.S. growth initiatives, as well as fund other programs that support the long-term vision of our company. The third quarter, we again saw the tangible results of the efforts we've undertaken over the past year to reduce our operating expenses and cash use. Our cash loss in Q3 was $14.9 million, down more than 60% from a year ago.

This is all the more significant considering that we have been stepping up our investments in the United States. Among the recent initiatives was the decommissioning of one of our three manufacturing facilities. On September 3rd, we closed B15, our first facility we opened 15 years ago. Our operations team has been working to move capacity to our other two manufacturing facilities in Costa Rica, including our new Sulayom campus, and these efforts are expected to drive additional cost savings. As a reminder, Peter Caldini joined us in August as president, and he's very focused on expanding our efforts to find efficiencies across the organization. EBITDA loss improved to $7 million this quarter from over $16 million last year.

Our successful launch in the United States and the gross margin expansion it will bring, along with our continued focus on cost reductions, should take us to the first positive EBITDA quarter in 2025. Revenue in the third quarter of 2024 totaled $40.2 million, in line with our expectations and reflecting the normal seasonality we see in our markets. Overall, global demand remains uneven, due primarily to macroeconomic pressures. The breast implant industry has seen periods where the market ebbs and flows, but it is much more about the ability of women to pay for these procedures, not their willingness to get them. Over time, these trends invariably normalize, and we expect they will in this case as well. Once women make a decision to have a breast augmentation, they generally convert at some point.

When there are macroeconomic concerns pressuring demand, women that are considering augmentation but that do not have the money to do so will create demand in the future. Latin America and Brazil, in particular, continue to underperform right now. Demand for breast procedures is down as much as 50% in certain regions of Brazil. Despite the challenging macro conditions in some markets, we were able to successfully grow our OUS business behind the introduction of Motiva in China, continued growth in Mia procedures, and the market share gains afforded by our differentiated product portfolio. Most important to our company's future right now is the United States, and plastic surgeons in the U.S. have welcomed a new entrant and new technology to the market with open arms. The community is incredibly active on social media, extolling the benefits of our technology to their patients.

There has been a similar response in the press, all of which creates inbound calls to plastic surgeons, some of which have been trained on Motiva, and some of which are now actively reaching out to us so they can offer Motiva as well. We began shipping to accounts two weeks after approval, and as of last Friday, three weeks into the launch, we already had over 250 accounts on board, and more than 70 had already placed orders. Right now, we are signing up to 50 new accounts every day, and several accounts have already exceeded 25 orders. We may do as much as $3 million in the last two months of the quarter alone, putting us on a strong trajectory for growth in 2025.

We now have 32 sales reps in the field supporting our commercial activities, and we expect to be at 40 by the end of the year. We are attracting the most experienced and highly regarded salespeople in our industry. The people closest to the markets are recognizing what a game-changer Motiva Implants are going to be in the United States, and they are joining us at Establishment Labs. Flora, our unique tissue expander, continues to gain traction. We have completed the VAC process at 29 of the premier cancer centers in the U.S., and more are pending. It is notable that many of these centers have expressed interest in Motiva Implants and have inquired about the potential approval dates for the breast reconstruction indications. This strong broad interest we are seeing for Motiva in the United States is not surprising. The market has seen no real innovation in decades.

Surgeons have been forced to adapt their practices and their surgical techniques to legacy devices developed with technology from last century, and U.S. surgeons and patients are recognizing the difference with Motiva. The success of the launch in the U.S. and the recent decommissioning of one of our manufacturing facilities have created some short-term supply challenges. We are scaling manufacturing and expect inventory pressures to abate in the first quarter. With this strong start to sales, we are confident that U.S. revenue in 2025 will exceed $35 million. Mia Femtech continues to build a new category in breast aesthetics. By providing a minimally invasive solution that overcomes many of the obstacles of traditional breast augmentation, we are opening up a new group of women to breast aesthetics.

It has been important for us to roll out Mia in a way that establishes it as a new category that delivers on the significant potential it has for patients, clinics, and our company. We have collected a number of data points over the past few quarters showing that Mia is doing just that. The average consideration time for Mia Femtech is two months compared to three to seven years for traditional breast aesthetics. The premium price point at these clinics for Mia is 30%-50% higher than a traditional breast augmentation at the same center. Throughout this year, over 40% of women who chose Mia were not seeking a traditional breast augmentation. With the experience to date, we now have proof that Mia is bringing new women into the category at higher price points and with a shorter consideration period.

We are moving beyond the proof-of-concept phase, and we expect to see a steady increase in the number of clinics globally over 2025. We now offer Mia Femtech in 29 cities across the world, with 78 plastic surgeons fully certified to provide the Mia experience. 47 clinics are currently under negotiation to become Mia-certified centers. This past week, at the 9th World Symposium on Ergonomic Implants in Barcelona, we shared the three-year data from the Mia Femtech study. This IRB-approved prospective study enrolled 100 Mia cases between December 2020 and April 2021. In the three-year analysis, there were no reports of capsular contracture and no ruptures. There continues to be no reports of infection, hematoma, or seroma, and more importantly, no reports of inferior implant malposition and no changes in nipple or breast sensation.

This means that with Mia Femtech, both device-related and technique-related complications are almost nonexistent after three years. Mia is ushering in a new era of minimally invasive breast aesthetics. The three-year data and the outcomes we are seeing in the real world have proven that maintaining breast tissue has advantages beyond the purely procedural benefits of a minimally invasive procedure. By not cutting the breast tissue, but rather preserving it as the tools used in Mia allow, the results can be much more predictable and stable. This concept of breast tissue preservation is starting to resonate with plastic surgeons, and you will hear us talking more about it in the coming months. In China, we remain on track to achieve our targets this year as we are building a foundation for continued growth.

Our exclusive Chinese partner, in coordination with our global team, is conducting medical education training and marketing events across Tier one and Tier two cities. Importantly, our Chinese partner has also signed an agreement in principle with R-Bridge Fund, an affiliate of CBC Group, for a strategic financing of up to $50 million in non-dilutive capital to fund commercial activities in support of the continuous growth of Motiva in China, as well as development towards regulatory approvals for our innovation pipeline, including Ergonomix2 and Mia Femtech. We are very confident that this investment will help us become the leading technology in China. Subject to customary conditions, we anticipate this financing to close within the current quarter. I will now turn the call over to Raj.

Raj Denhoy (CFO)

Thank you, Juan José. Total revenue for the third quarter was $40.2 million, an increase of 4.5% from the year-ago period. Foreign exchange had a negligible impact on sales results in the quarter. From a regional perspective, sales in Europe, Middle East, and Africa were approximately 49% of the global total, Asia-Pacific 27%, Latin America 24%, and North America was 1%. Latin America, and in particular Brazil, remain challenging. As we noted in previous calls, the Brazilian market continues to suffer from softer underlying demand, and we do not expect to see improvement this year. Our gross profit for the third quarter was $25.7 million, or 63.9% of revenue, compared to $26.1 million, or 67.7% of revenue for the same period in 2023.

Our gross profit in the third quarter was impacted by the revaluation of our euro-denominated inventory at quarter-end, which had a negative impact on our cost of goods. This lowered our reported gross margin by approximately 80 basis points. Average selling prices in the quarter were similar to last year. SG&A expenses for the third quarter declined approximately $5.9 million-$34.1 million, compared to $40 million in the third quarter of 2023. R&D expenses for the third quarter declined approximately $2.3 million from the same quarter a year ago to $4.8 million. Total operating expenses for the third quarter were $38.9 million, a decrease of approximately $8.2 million from the year-ago period.

The decrease in operating expenses in the third quarter was primarily the result of cost reduction initiatives we undertook in the second half of 2023, which we have continued into 2024, offset by increasing investments in our U.S. commercial operation. Net loss from operations in the third quarter was $13.1 million, compared to a net loss of $21 million in the same period in 2023. Adjusted EBITDA was a loss of $7 million in the quarter, compared to a loss of $16.3 million in the third quarter of last year. We have taken tangible steps to reduce spending over the recent quarters, and we have reduced our operating loss meaningfully, even as we have increased spending on the launch of Motiva in the United States. Cash use in the quarter was $14.9 million. This compared to $38 million last year.

In the third quarter, inventory increased in preparation for the U.S. introduction of Motiva, and accounts receivable were also higher as we saw higher sales to distributors. Our cash position on September 30th was $39.7 million. Following FDA approval of Motiva Implants, we drew the next $25 million tranche of our credit facility on October 8th. The net proceeds put our pro forma cash position at approximately $64 million. After the market closed today, we announced completion of a registered direct offering. The offering was priced at a 5% discount to today's closing price, and before expenses, we raised $50 million. With the proceeds, our pro forma cash position at the end of Q3 was approximately $114 million. We also announced today that we have amended our existing credit facility, where we extended the time when we can draw the final $25 million tranche to December 31st, 2025.

We are updating our revenue guidance for the year to $165-$168 million. While we are seeing good performance in a number of regions and continue to take market share, underlying market demand remains uneven and is down in some markets. Latin America, especially Brazil in particular, continued to underperform. We've also taken into consideration that while the U.S. is off to a great start, the approval came about six to eight weeks later than we had expected. We will give a more detailed view on 2025 when we report our Q4 results. However, for budgeting purposes, we are planning on our business outside the U.S. to grow in the mid-single digits next year, and as JJ noted, we expect the U.S. will exceed $35 million in revenue. Our outlook for next year is also built with the intent of having our first EBITDA positive quarter in 2025.

Thus, our budgeting assumes a conservative first cut. We're not assuming a significant rebound in Brazil or other markets. Starting with a conservative view and setting our internal spending targets against them should allow us to confidently reach our profitability targets. Gross margins in 2024 should be approximately 100 basis points higher on an underlying basis. However, on a reported basis, we expect gross margins to be similar to 2023 levels. With the higher selling prices in the U.S. and with our other new products, we expect gross margins will be meaningfully higher in 2025. We remain very focused on managing operating expenses, which can be seen in the almost $19 million reduction in operating spending over the first nine months of this year compared to last year.

With the FDA approval of Motiva Implants and the strong demand we are seeing in the United States, we will see increased commercial and operational activity. As such, overall operating expenses will increase in the last couple of quarters. Achieving positive Adjusted EBITDA and positive cash flow remain very important goals for us as a company, and as I noted, we are on track to turn EBITDA positive in 2025. I will now turn the call back to Juan José.

Juan Chacón-Quirós (CEO)

Thank you, Raj. The FDA approval of Motiva has opened the door to the next phase of growth for our company. Not only do we have access to the largest global market, but the U.S. commands among the highest gross margins in the world. As such, we expect to not only see growth accelerate meaningfully in 2025 and sustain at a high level, but with the spending discipline we have shown over the past year and with the economics of our business in the United States, we are on a clear path to profitability. Our balance sheet has been strengthened to where we are fully funded to take advantage of our U.S. launch and to continue to launch innovations for years to come, all of which will create value for our shareholders. When we founded this company 20 years ago, we always knew that entering the U.S.

market was the ultimate validation for our technology. We now have the entire global market open to us, and we look forward to many years of very strong growth ahead. I will now turn the call over to the operator for your questions.

Operator (participant)

Thank you. At this time, we'll be conducting a question-and-answer session. If you'd like to ask a question, please press Star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press Star two if you'd like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the Star keys. One moment, please, while we poll for questions. Our first question comes from Allen Gong with J.P. Morgan. Please proceed with your question.

Allen Gong (V.P)

Hi. Thanks for the question. I had, you know, the first question on the U.S. launch. It's great to hear that it's off to a stronger-than-expected start. You know, when we think about the, you know, $30 million-$35 million+ expectations for next year, what does that really, you know, contemplate when it comes to the ramp this quarter and your ability to kind of sustain momentum next year?

Juan Chacón-Quirós (CEO)

Thanks, Allen. And if I hear you correctly, I think you want to get our view on how we ramp this business. And I think I will point out to, you know, the fundamentals. Number one, the quality of our sales reps. These are the best in the industry. We have now 32, and we'll have 40 by the year-end. You know, the speed at which we are onboarding new accounts, basically an average between 50 and 20 per day, already onboarded at 250 accounts, 70 have ordered more than 25 times. Social media, PR, everything that is going on speaks of the shift, the paradigm shift that we are seeing in the U.S. market. So, of course, you know, the first few months, you're building your base of accounts, but these accounts are already ordering and reordering, and that tells you where this is going.

I think when we speak of, you know, our ability to bring at least $35 million next year, it shows our conviction that, you know, this is a market that we can take based on the quality of our technology and the differentiation.

Allen Gong (V.P)

Got it. And then kind of my follow-up is on the other 2025 commentary that you gave, the kind of 5% OUS growth. Should I basically be thinking about that as, you know, your current business minus the $3 million that you expect to generate from the U.S. in fourth quarter and growing that mid-single digits? If so, I think that's, you know, kind of a good bit slower than us on, you know, on the street worth thinking, especially with China still in the early stages of launch, and that looks like the rest of APAC and EMEA doing better, even if LATAM is going to continue to be weak. So, you know, one, is that the right way to think about it? And two, why, why would that be the case? Why wouldn't you be able to do better than mid-single digits?

Raj Denhoy (CFO)

Yeah, Allen, thanks for the question. You know, as we noted in the commentary, you know, this is really a first cut at 2025 for us, right? And, you know, we're setting a conservative outlook to start the year, but importantly, we're also building our budget against that, our expense budget against that, because we've also commented about the goal we have to have an EBITDA positive quarter next year, right, to break into that profitability phase of the company. And so for us to start with a conservative view on the top line and then build an expense base against that is what we're trying to accomplish. But absolutely, it's a conservative number to start the year, and everything you're describing will play out, I think, for us next year.

But again, we want to just start at a place where, you know, where we can build a reasonable expense base against that.

Operator (participant)

Our next question comes from Matt Taylor with Jefferies. Please proceed with your question.

Matt Taylor (Analyst)

Hi. Thanks for taking the question. I was hoping to get a little bit more color on China. If you could talk about how you're progressing against your goals this year to get the initial stocking orders and reordering there and understand anything that you can give about China growth in 2025, and really want to dig into what this $50 million investment does. What do you think it's going to do for the ramp of Motiva products in China?

Raj Denhoy (CFO)

Yeah, thanks, Matt. So, you know, one of the important things is that, you know, China, you know, in general, when it comes to consumer spending, it's been a tough year in China in 2024. But as you well know, you know, the Chinese government is undertaking a series of measures to really prop up, consuming, consumers across, all of China. And we think it's the right time for this type of, investment into the Chinese market. So we are very happy to see Motiva China, our partner, you know, joining R-Bridge Fund, part of CBC, for this investment. And this investment is to, you know, basically advance the growth of Motiva in China and also, more importantly, bring the Ergonomix platform and Mia to China. When it comes to Mia, China was the number one market in our market studies.

So, you know, as we look at what we have done this year, we're very happy with, you know, the things that we have undertaken in terms of the deployment of inventories into tier one and tier two cities, medical education across the board, and continuous improvements that we are seeing in the pace of our marketing activities. So, you know, as we go into 2025 and beyond, we think that this level of investment shows the commitment of our partners into making China, just like the other countries in the periphery in Asia, you know, a leadership market for Motiva.

Allen Gong (V.P)

That's great. I guess just to help with the modeling, could you be any more specific on how China's done this year? You talked about a $10 million stocking over the, you know, the course of the year. Are you going to go beyond that with reordering? And can you give us any color on how China could contribute next year?

Raj Denhoy (CFO)

I think it's a little bit early to talk about next year, but clearly we're on track to do the 10 million that our distributor there has committed to doing. You know, as we move into next year, we'll start to see the pace of reordering. But as Juan José noted, this investment that they're receiving from CBC and the excitement we're seeing about the products there, we have, you know, we have high hopes for what they'll do next year. But I think it's a little bit early to talk about the contribution in 2025.

Allen Gong (V.P)

All right. Thanks, Raj.

Operator (participant)

Our next question comes from Marie Thibault with BTIG. Please proceed with your question.

Marie Thibault (Analyst)

Hey, good afternoon. This is Sam Long from BTIG. Thanks for taking the questions and formal congratulations on the U.S. approval. Maybe I can start on some of the non-LATAM markets. I want to better understand maybe what you're seeing in Europe, and maybe some of the non-China APAC markets. And then another thing about direct versus distributor, you know, are we at a point where maybe distributors are back to normalized inventory levels, or do you think maybe there's still some more catch-up that needs to happen?

Juan Chacón-Quirós (CEO)

Yeah, thank you. So, you know, over the course of this year, we have been talking about markets stabilizing at different speeds across the world, but we continue to see macroeconomic pressures, notably in LATAM, and especially in Brazil. And the environment is not deteriorating further in that region, but our hope for a rebound in the second half of this year has not really taken place. Now, you know, to your question, when you look at EMEA, that's a region where, you know, we have seen markets stabilizing with actually some markets even growing. And that's a region in which we have a combination of both direct markets and distributor markets. Then when you look at APAC, APAC has also been stabilizing, but we believe there is still room for improvement in certain markets in the region. And that is a pure distributor region for us.

I also want to point out that there's no structural change to the demand for breast aesthetic procedures. The economic picture has made it harder for women to access it at this time in some regions in the world. But I really want to emphasize something. Make no mistake, we will grow this year in the EMEA region and APAC regions in our core business compared to 2023, and we continue to gain market share across the globe. So it is important that we say these things because, you know, we don't want the picture of our business to be one that is not based on growth, as we have pointed out in the script and now.

Marie Thibault (Analyst)

Really helpful, Juan José. Thanks for the added color there. Maybe just a follow-up question on some of the short-term supply challenges. Just want to clarify, is that going to have any impact on your ability to maybe meet, you know, near-term demand, or is that something that should be worked through without any impact?

Juan Chacón-Quirós (CEO)

Yeah, I think that's an important point. You know, we had planned for a long time the decommissioning of our B15 manufacturing facility. That facility had been, you know, manufacturing for the last 15 years. And, you know, it had a date for decommissioning. So we are moving capacity into our two other manufacturing units. So, you know, in that process, there are some pressures. So there will be an impact into Q4. So hence the change in the guidance for this year. But we think that this will abate by Q1. We are adding manufacturing capacity in both of these sites, in one of them, including a third shift. So we will be ready.

Marie Thibault (Analyst)

Understood. Thanks for taking the questions.

Operator (participant)

Our next question comes from Joanne Wuensch with Citi. Please proceed with your question.

Joanne Wuensch (Analyst)

Hey, good afternoon. This is Evan Young for Joanne. Thanks for taking our questions. Do you, in the U.S., do you have a target U.S. account number you're hunting towards that we should be thinking about, and then on the 40 reps, do you think that's sufficient to serve the U.S. market, or how should we be thinking about potentially the expansion of that sales force in 2025?

Juan Chacón-Quirós (CEO)

Yeah, thank you. Well, not long ago, we were talking about having 12 sales reps, and you've seen how fast we've moved to 32. And these are not just any sales reps. These are the best in the industry. As you can see by the speed and the quality of the accounts that we are onboarding, the speed at which they are ordering for the first time and then reordering. And then, you know, when we look at from now to the end of the year, we will be adding eight more sales reps. And we will be adding more sales reps next year. As you know, our base of accounts expands, we will be having more sales reps. And that is natural. On top of that, I think that, you know, our entire infrastructure in the U.S. continues to get strengthened.

You know, we are adding people in the back office. We will be adding inventories necessary for the growth. And, you know, that's what the company is focused on. Because if you look at next year, our plan is to take significant market share in the U.S. market. And, it will be one of the key factors for our growth next year.

Joanne Wuensch (Analyst)

Thanks for taking the question.

Operator (participant)

Our next question is from Josh Jennings with TD Cowen. Please proceed with your question.

Josh Jennings (Analyst)

And wanted to focus on the recently held ergonomic symposium. You guys announced Mia three-year data. Can you just talk about whether or not that those data will be enough to submit to the FDA through a supplemental PMA pathway? And have you had any discussions on the Mia pathway with the FDA? And then the second question is just if you could maybe just give us some color on what occurred over in Barcelona, any new pipeline updates that you can relay or anything else, maybe even just the buzz that was out there from the clinical community. Thanks for taking the questions.

Juan Chacón-Quirós (CEO)

Yeah, thank you, Josh. Barcelona was once again a phenomenal opportunity for Establishment Labs to showcase its latest technological improvements. You know, the three-year data of Mia is, you know, what we are about, showing with data that, you know, not only we can improve device-related complications, but now with Mia, which is, you know, changing the way surgeons are doing breast augmentation and breast harmonization because of breast tissue preservation. And that's what it does, and, you know, the results for the study show it, is that basically you're also almost eliminating technique-related complications. And that is a very powerful combination. Our future is based on breast tissue preservation across the board. You will see us talking more and more about it. We had more than 500 people in attendance.

You know, that included not only some of the best plastic surgeons around the world, but also our business partners. I think everyone is powered up not only by the FDA approval, which of course has an effect on the image and the credibility of our entire platform across the world, but also, you know, on the things that we are bringing to market because Mia will continue to expand. You know, we talked about, you know, 29 cities now, which is seven more cities than last quarter, 15 more plastic surgeons, 47 clinics in the pipeline. I think most importantly, and I think that gets perhaps a little bit lost, is that, you know, this year, it's only been 12 months really since the first clinics launched and only six months and three months since a big chunk of those clinics have launched.

And yet what we see is that, you know, so far in this first 12 months, more than 40% of patients getting Mia are new to the category, which means they were not looking for a breast augmentation. Premium pricing, 30%-50% over the same price in the same clinic for a traditional breast augmentation, two months versus three to seven years consideration time. So that's what we wanted to show, that this is really a new category. 2025 will be, you know, about expanding the number of clinics, bringing the capillarity of Mia across the board by adding cities and countries. So, you know, we will be seeing, engaging, and giving more data about how we grow the number of clinics and the number of procedures per clinic in 2025 because that will be the focus.

Josh Jennings (Analyst)

Great. And thanks for all that. And just maybe anything you can share just on the Mia, U.S. regulatory path and whether supplemental PMA is a possibility and any discussions with the agency.

Juan Chacón-Quirós (CEO)

Yes, I'm sorry for not answering before. We are looking, you know, at having a conversation with the agency regarding not only Mia, but the Ergonomix2 platform. And, you know, Mia has other components in addition to the breast implant that is part of it. So, you know, we're working hard with our regulatory team to have this conversation soon enough. So, you know, we're not trying to rush things, but at the same time, we do want to get it done.

Josh Jennings (Analyst)

Thanks. And, my apologies for a multilayered question there. Thank you.

Juan Chacón-Quirós (CEO)

No problem.

Operator (participant)

Our next question comes from Anthony Petrone with Mizuho Group. Please proceed with your question. Anthony, are you there or muted? Anthony, are you muted?

Anthony Petrone (Analyst)

I was muted. I apologize for that. Thank you and appreciate that. Thanks for fitting us in here for a question. I know a lot has been asked, but just a couple maybe on, as we think about, sales force building the United States and the cadence, if you could maybe just give us an update on where you sit in the U.S. for the sales force exiting the quarter. And as you think about, you know, building that out through 2025, how should we be thinking about that from a, a headcount addition and just, you know, layering that into the SG&A line? And then, you know, secondly, maybe just a little bit of an update on next catalysts for additional FDA clearances following Ergonomix, following Round and Ergonomix. When could we expect Ergonomix2? And anything you can share on Mia in the U.S.?

I know it's a little bit further in the calendar, but any other color there would be helpful. Thanks.

Juan Chacón-Quirós (CEO)

Yeah, thank you, Anthony. I think it's important to realize that, you know, we've really been speeding up the number of sales reps. Not long ago, we were at four, then eventually 12. In the last two months, it's gone to 32, and we'll be at 40 by the end of the year. So we will continue to add more sales reps throughout next year, quarter to quarter. And, you know, we will do so at the speed that is required. It is important to understand that, you know, Motiva is a special type of game-changing technology, and it requires, you know, the time and the quality of the surgeons. So, for us, it is important to, you know, to be mindful of how we grow. So we talk about, you know, we've done in the last 14 years over 85 countries' launches.

So that's a lot of experience. So we really know how to do this. And if you look at, you know, the team that we have in place with Jeff and Anne, leading that team and all of their experience, they know exactly what they are doing. And, you know, if you look at what's coming, you know, over the next few years, we're going to see, you know, a super cycle of innovation in the United States. We're going to get, you know, the breast reconstruction approval, indication for, you know, breast reconstruction. On top of that, you know, we will be working towards getting the Ergonomix2 platform. And from there, not only you get, you know, the program related to Mia, but also the program related to JOY and breast tissue preservation.

Of course, we have other things coming that we've talked about before with GEM, which is for ergonomic modeling of the gluteal area and also our sensor technology. So a lot of things will be coming to plastic surgeons in the United States. But I'll also point out something else, you know, that I think people should not forget. That's part of what we are talking about today is the road to profitability. You know, if you look at the improvements over the last 12 months, you know, not only we talked today about an increase in revenue, but also, you know, the improvement in EBITDA, 58% cash use, 60% improvement, OPEX, 18% improvement. We've done this while reducing our entire employee base by 20% and adding, you know, U.S. employees and investing in the U.S. market.

So I think that's a pretty impressive way to describe, you know, what this company has been doing. And now that we have the FDA approval, you know, we will be getting into the market with the highest gross margins. And I think that that's what signals not only our first EBITDA positive quarter next year, but eventually how we get to cash flow positive as a company.

Anthony Petrone (Analyst)

Helpful. One follow-up just on the OUS commentary, guiding to 5% OUS growth. Maybe when we think about, you know, just the inputs into that, that forecast and, you know, potential areas of risk, but also on the flip side where it potentially can be conservative. And really where I'm going is, you know, trends on the ground in China versus trends on the ground in Brazil, what gives you some encouragement in each of those regions and where is there potential risk? Thanks again and congratulations on the U.S. Motiva clearance.

Raj Denhoy (CFO)

Yeah. I mean, as I noted earlier, Anthony, I mean, it's a conservative start to the year, right? It's really a budgeting number for us. And so, as you described, there's lots of puts and takes in the next year, right? We're not expecting anything heroic out of China, but certainly the size of that market and the investment that our partner there has received really sets that up for a nice potential run in that market. You know, certainly the U.S., right? Which, I guess you're asking about OUS, but the U.S. is going to be the big driver for us next year overall for growth. And then outside, you know, we continue to see pockets of macroeconomic softness, but, you know, things can improve, which we expect they will.

You know, as Juan José mentioned, we are seeing, you know, decent growth in Mia right now, pockets of growth there. APAC is stabilizing, but there's still room for improvement. You know, and LATAM has been the, you know, the big weak spot for us this year. And so there's a lot of room for that to start to step up. And so for us, I think, you know, what we're setting up for us for 2025 is really just a conservative way to start the year. And we absolutely expect to do better.

Juan Chacón-Quirós (CEO)

Yeah. And, Anthony, to give you more precision on, you know, path for, you know, Mia in the U.S., I just want to like reinforce that we are in discussions with the FDA on pursuing the quickest pathway for it. And of course, we're going to leverage the already completed data globally, like the one we showed at the World Symposium on Ergonomic Implants. And we will target via a supplement, of course.

Operator (participant)

So much. That is all the time we have for questions today. I will now turn the call back over to Juan José Chacón-Quirós for closing remarks.

Juan Chacón-Quirós (CEO)

Thank you for joining us on today's call. We will be at several conferences over the next couple of months, including the UBS Global Healthcare Conference, the Jefferies London Healthcare Conference, the Stephens Investment Conference, the Citi Global Healthcare Conference, and the Mizuho Healthcare Conference. We look forward to seeing you at any of these events. We wish everyone continued good health and happiness.

Operator (participant)

This concludes today's conference. You may disconnect your lines at this time. And we thank you for your participation.