Establishment Labs Q4 2024 Earnings Report

Establishment Labs EPS Results

• Actual EPS: -$0.98
• Consensus EPS: -$0.64
• Beat/Miss: Missed by -$0.34
• One Year Ago EPS: N/A

Establishment Labs Revenue Results

• Actual Revenue: $44.51 million
• Expected Revenue: $44.45 million
• Beat/Miss: Beat by +$67.00 thousand
• YoY Revenue Growth: N/A

Establishment Labs Announcement Details

• Quarter: Q4 2024
• Date: 2/26/2025
• Time: After Market Closes
• Conference Call Date: Wednesday, February 26, 2025
• Conference Call Time: 4:30PM ET

Establishment Labs (NASDAQ:ESTA), a medical technology company, manufactures and markets medical devices for aesthetic and reconstructive plastic surgery. The company primarily offers silicone gel-filled breast implants under the Motiva Implants brand. It also provides Motiva Ergonomix and Motiva Ergonomix2 gravity sensitive round soft silicone-gel-filled breast implants; and Motiva Flora Tissue Expander, a breast tissue expander. The company sells its products to physicians, hospitals, and clinics through distributors and direct sales force in Europe, the Middle East, Latin America, and Asia. Establishment Labs Holdings Inc. was incorporated in 2004 and is headquartered in Alajuela, Costa Rica.

Establishment Labs Q4 2024 Earnings Call Transcript

Presentation

[Operator]

Good afternoon. Welcome to Establishment Labs' Fourth Quarter twenty twenty four Earnings Call. At this time, all participants will be in a listen only mode. At the end of this call, we will open the line for a question and answer session and instructions will follow at that time. As a reminder, today's call is being recorded.

[Operator]

I will now turn the call over to Raj Denhoi, Chief Financial Officer. Please go ahead.

[Raj Denhoy, CFO at Establishment Labs Holdings]

Thank you, operator, and thank you, everyone, for joining us. With me today is Juan Jose Kone Quiros, our Chief Executive Officer and Peter Caldini, our President. 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 Establisha Labs' financial outlook and the company's plans and timing for product development and sales.

[Raj Denhoy, CFO at Establishment Labs Holdings]

These forward looking statements are based on management's current expectations and involve risks and uncertainties. For a discussion of the principal risk factors and uncertainties that may affect our performance or cause actual results to differ materially from these statements, I encourage you to review our most recent annual and quarterly reports on Form 10 K and Form 10 Q as well as other SEC filings, which are available on our website at establishmentlabs.com. I'd I'd also like to remind you that comments may include 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, 02/26/2025.

[Raj Denhoy, CFO at Establishment Labs Holdings]

Except as required by law, Establishment Labs undertakes no obligation to revise or otherwise update any statement to reflect events or circumstances after the date of this call. With that, it is my pleasure to turn the call over to our CEO, Juan Jose.

[Juan Jose Quiros, Founder, CEO & Executive Director at Establishment Labs Holdings]

Thank you, Raj, and good afternoon, everyone. Revenue in the fourth quarter of twenty twenty four totaled $44,500,000 in line with our expectations and with what we pre announced in early January. For the full year, our sales were $166,000,000 We remain committed to our forecast with 2025 guidance between $2.00 $5,000,000 and $210,000,000 At its midpoint, this is 25% growth over 2024. With our launch in The United States, the fourth quarter was easily one of the most important in our company's history. U.

[Juan Jose Quiros, Founder, CEO & Executive Director at Establishment Labs Holdings]

S. Sales totaled $3,300,000 in the first two months of the launch, a bit better than we pre announced in early January. This is an incredibly strong start. And our U. S.

[Juan Jose Quiros, Founder, CEO & Executive Director at Establishment Labs Holdings]

Commercial team, one of the strongest teams ever put together in aesthetics, deserves recognition for their efforts. This strong start has continued into Q1 and the activity and interest around Motiva continues to grow. In the fourth quarter, we continue to see the tangible results of the efforts we've undertaken over the past year to reduce our operating expenses and cash use. In 2024, our total operating expenses were $12,500,000 lower than in 2023. And this includes our 2024 spend to build the commercial infrastructure for rollout in The United States.

[Juan Jose Quiros, Founder, CEO & Executive Director at Establishment Labs Holdings]

EBITDA loss improved to $13,100,000 this quarter from $17,400,000 last year. Our successful launch in The United States and the gross margin expansion it brings, along with our continued focus on operational efficiency, should take us to our first positive EBITDA quarter in 2025. Outside The United States, global demand remains uneven, but our data suggests that we are picking up market share as all aesthetic companies manage through this period. This low in aesthetic demand has happened before and it has always recovered. Specifically, we believe a number of countries in EMEA were down last year, in some cases meaningfully, and yet our revenue remained flat in that region.

[Juan Jose Quiros, Founder, CEO & Executive Director at Establishment Labs Holdings]

Asia Pacific in 2024 has been recovering from the sharp downturn we saw in the second half of twenty twenty three. This regional strength was offset by the continued weakness in Latin America. Excluding currency and other external items, revenue in LatAm in the fourth quarter of twenty twenty four was flat from the previous year, suggesting that our results are stabilizing in that region. 2025 should mark a gradual return to growth outside The United States. And while we are being conservative, as markets and regions return, growth in the mid single digits in these markets looks very achievable.

[Juan Jose Quiros, Founder, CEO & Executive Director at Establishment Labs Holdings]

We have also not included any significant contribution from new products or regulatory approvals, which could provide an upside to our numbers. While OUS remains the largest segment for us, most important to our company's future is The United States, and our results continue to exceed our expectations. We have 40 sales reps active in the field. We continue to attract the best and brightest in the industry and will expand this team in 2025. As of last Friday, we have over six fifty accounts fully onboarded and four fifty have already placed orders with 88% reordering.

[Juan Jose Quiros, Founder, CEO & Executive Director at Establishment Labs Holdings]

These are all well ahead of our expectations. We continue to sign up an average of five new accounts every day. Momentum is building. In November, we averaged 32 orders per day. In December, we averaged 60 orders per day.

[Juan Jose Quiros, Founder, CEO & Executive Director at Establishment Labs Holdings]

In January, we averaged 70 orders per day. And in February, we should average about 90 orders per day. Since launch, we have had more than 5,000 orders. We expect to generate approximately $5,500,000 in sales in the first quarter, putting us on a strong trajectory to exceed our guidance of $35,000,000 in sales in 2025 for The United States. Please remember that breast augmentation is seasonal.

[Juan Jose Quiros, Founder, CEO & Executive Director at Establishment Labs Holdings]

Second and fourth quarters are the strongest. First and third are the weakest. We are on pace to have one of the best launches in the history of the aesthetics industry. As we study our initial rollout, we are seeing confirmation that The United States will likely mimic our initial rollout in Switzerland, South Korea and Taiwan, markets that are relatively high priced smooth implant markets. In Switzerland, we reached 50% market share after five years in the market and 70% market share at year ten.

[Juan Jose Quiros, Founder, CEO & Executive Director at Establishment Labs Holdings]

In South Korea, we reached 40% market share after four years in the market and 65% market share in year eight. In Taiwan, our latest launch, we have now reached 40% market share after four years. Beyond the strong financial results, the interest in Motiva among plastic surgeons, the media and most importantly, women has been nothing short of remarkable. We hear a constant refrain from plastic surgeons. When given a choice between Motiva and other implants, patients almost always choose Motiva.

[Juan Jose Quiros, Founder, CEO & Executive Director at Establishment Labs Holdings]

This is true even though Motiva implants have a higher blended price point. In these first five months of the launch, we have seen almost without exception that plastic surgeons who convert to Motiva stay with Motiva. And for most of those who started early in our launch, Motiva has become the vast majority of their implant usage. In just a few months, there have been over 60 press articles mentioning Motiva and hundreds of social media posts from surgeons. We have had over 1,800,000,000 impressions from this activity.

[Juan Jose Quiros, Founder, CEO & Executive Director at Establishment Labs Holdings]

Importantly, all of this is happening organically without financial support. I would encourage you to follow the content being created by many plastic surgeons and clinics on Instagram, TikTok and other digital platforms as it speaks to the viral nature of our launch. With the buzz building, we have had a number of celebrities and influencers organically choosing Motiva and I would expect this to continue. With a differentiated value proposition, these women seem more open to discussing their choices and timing. This is unusual in aesthetics.

[Juan Jose Quiros, Founder, CEO & Executive Director at Establishment Labs Holdings]

Plastic surgery decisions tend to be kept private. Even more unusual is a discussion around specific brand choices. With this interest, we have been working on a partnership with an A listed celebrity who recently chose Motiva Implants, and we hope to announce it in the very near future. This should be very impactful, not just in The United States, but globally. Women tend to do partnership should also resonate with plastic surgeons, who often feel not supported by an aesthetic industry focused on other specialties.

[Juan Jose Quiros, Founder, CEO & Executive Director at Establishment Labs Holdings]

As we build the premier trusted company for plastic surgeons, these kind of efforts will make a big difference. In reconstruction, FLORA, our unique tissue expander, is gaining traction and we have completed the VAC process at 35 of the premier cancer centers in The United States. Thirty Two have already ordered and the other three were opened in the last thirty days. The recent scientific publication from an interdisciplinary group devoted to treating breast cancer and performing breast reconstructions at the MD Anderson Cancer Center in Texas concluded that the integration of MRI CTEs into radiation therapy planning has streamlined the process, reduced the need for artifact management and improve the accuracy of those calculations, ultimately contributing to better clinical outcomes. As a woman's health company, we are pleased to witness the positive impact of our technologies like Flora in the process of treating breast cancer and helping women recover to their fullest after survival.

[Juan Jose Quiros, Founder, CEO & Executive Director at Establishment Labs Holdings]

This will be a busy year for regulatory team in The U. S. As we seek clearance for a number of products. In reconstruction, we are on track to reach the three year follow-up in the third quarter of this year. This puts us on track to submit to the FDA this year with a potential approval for this indication in 2026.

[Juan Jose Quiros, Founder, CEO & Executive Director at Establishment Labs Holdings]

The reconstruction market is nearly as big as augmentation in U. S. And we are excited to bring our technologies to this important segment. We are also working on approval for the tools necessary to launch Preserve, including the submissions necessary for the Ergonomics two platform. The Ergo two platform will allow for us to bring Mia FEMTEC to The United States.

[Juan Jose Quiros, Founder, CEO & Executive Director at Establishment Labs Holdings]

We will provide some thoughts on the regulatory pathway and timing later in the year. Mia FEMTEC continues to build a new category in breast aesthetics. It is important to note that we launched MEA in Europe in late twenty twenty three. By the end of twenty twenty four, in less than eighteen months, we already had more than 60 clinics become MIA certified centers. As we see MIA sales ramp, it is becoming clear that a minimally invasive solution, which overcomes many of the obstacles of traditional breast augmentation can open up a new group of women to breast aesthetics.

[Juan Jose Quiros, Founder, CEO & Executive Director at Establishment Labs Holdings]

We have moved beyond the proof of concept phase and expect to see a steady increase in results from MIA over the coming quarters. For 2025, we expect the number of MIA certified clinics will at least double and that the number of MIA procedures globally will more than double. And we are forecasting approximately $8,000,000 to $10,000,000 in revenue from MIA this year. One of the key learnings from the three year data from the MIA IRB study and the outcomes we are seeing in the real world has been that preserving breast tissue has advantages beyond the periprocedural benefits of a minimally invasive procedure. By not cutting the breast tissue, but rather by preserving it as EMEA tools allow, the results can be much more predictable and stable over time.

[Juan Jose Quiros, Founder, CEO & Executive Director at Establishment Labs Holdings]

We pioneer the concept of breast tissue preservation and it is resonating with plastic surgeons who already appreciate the reduction of device related complications with Motiva, and now are also seeing a reduction of technique related complications, thanks to breast tissue preservation. With these fundamental concepts, we have developed Preserve, the next step in our minimally invasive portfolio. Mia's value proposition to patients is clear. It is intended for primary augmentations with a one to two cup size increase and for a scarless lift for women with mild breast ptosis. There are no scars on the breast and an imperceptible scar on the armpit.

[Juan Jose Quiros, Founder, CEO & Executive Director at Establishment Labs Holdings]

It is done under local anesthesia. As the MIA IRB study shows, there is no loss of breast sensation, no inferior malposition of the implant and it dramatically reduces patient recovery periods and complications traditionally associated with breast augmentations. It is also priced as our most premium product to reflect these aspects. Mia is designed to appeal to women who are not interested in breast augmentation, but are using padded or push up bras, and so by definition should be market expanding. Preserve is designed for the day to day procedures that make up the majority of breast augmentation.

[Juan Jose Quiros, Founder, CEO & Executive Director at Establishment Labs Holdings]

While Preserve should be market expanding over time, given its benefits, it is designed to be the premium choice for women who are already considering breast augmentation surgery. Preserve can be used for up to four cup sizes increase and can be used for primary augmentations, hybrid augmentations and for mastopexy augmentations. Preserve uses some of the surgical tools developed with Mia to make a precise atraumatic pocket, but the incision is made under the breast, which is a more familiar surgical technique for most doctors. The technology platform allows plastic surgeons to create natural results by preserving breast anatomy and function. We have been talking about Preserve with the plastic surgery community since last year, and they are eager to discuss with prospective patients.

[Juan Jose Quiros, Founder, CEO & Executive Director at Establishment Labs Holdings]

Preserve is a new choice for women considering breast augmentations, as it speaks to many of their aspirations, including more natural results, smaller scars and quicker recovery. By improving safety profiles, recovery times and achieving the breast aesthetic patients are looking for, Preserve has the potential to make breast augmentation more appealing to women and make the decision easier for many who are already in the consideration phase. We launched Preserve earlier this month in Brazil and it is clearly resonating. In the first week post launch, we have seen significant interest and have already received many orders for hundreds of systems at a price point more than double our most common SKUs in Brazil. We will continue our rollout into additional countries and regions over the coming quarters.

[Juan Jose Quiros, Founder, CEO & Executive Director at Establishment Labs Holdings]

We expect that both breast tissue preservation options, MEA and Preserve will dramatically change surgeons approach to breast aesthetics and have a significant impact on future growth. Preserve will bridge the price gap between existing Motiva offerings and MEA and will be at the upper end of our pricing matrix. Finally, it is worth noting that GLP-one usage is going to be a major tailwind for years to come. Much of this demand is market expanding. And while we are starting to see it now where GLP-one adoption is more prevalent, we do expect this to be a global tailwind.

[Juan Jose Quiros, Founder, CEO & Executive Director at Establishment Labs Holdings]

Our products and messaging with Mie and Preserve are particularly suited for women that are considering augmentation as a way to reverse some of the iatrogenic consequences of GLP-one weight loss, and we expect to do very well in this new market segment. 2024 was an important year for us in China. We established our presence in the market with our exclusive distribution partner and began building the foundation for market share gains. As we have commented previously, the first year of any distributor market will be about sell in as the distributor puts inventory into the field and begins commercial sales. We will now see the sellout as our partner grows share in the market.

[Juan Jose Quiros, Founder, CEO & Executive Director at Establishment Labs Holdings]

Based on this dynamic, we do not expect to see revenue in the first part of twenty twenty five with reorders beginning more meaningfully in the second half of the year. This is a natural cadence for distributor markets and allows us to maintain a healthy level of inventory in the channel. The ordering pattern is reflected in our guidance for this year. Importantly, our Chinese partner recently signed an agreement with CBC Group for strategic financing of up to $50,000,000 to fund commercial activities in support of the continuous growth of Motiva in China. This investment is being used to increase the number of sales reps across China and adding more regional commercial dealers.

[Juan Jose Quiros, Founder, CEO & Executive Director at Establishment Labs Holdings]

We have already began to see the tangible results with end consumer sales in the first part of this year increasing meaningfully from last year. We are very confident that this investment into our partner will help us become the leading technology in China in the next few years and is already the case in the rest of Asia. I will now turn the call over to Peter.

[Peter Caldini, President at Establishment Labs Holdings]

Thank you, Juan Jose. This is my first call since joining Establishment Labs, and I am excited to be here at such an exciting time for the company. When I first looked at Establishment Labs, I had some preconceived notions of what the breast augmentation industry could be. However, on my first trip down to Costa Rica, I realized what an amazing company and opportunity existed. Our innovations are radically changing the breast augmentation and reconstruction industries, opening the procedure to many women who would not have considered it previously.

[Peter Caldini, President at Establishment Labs Holdings]

Our Motiva implant has FDA data that is remarkably better than any data ever seen in a breast implant trial. These are not small differences, and it creates a huge opportunity to build a best in class company and reshape an industry. Managing growth and opportunity of this skill has its own challenges, and that is why I'm very excited to be part of the team. Marrying growth and opportunity with efficiency and productivity is where I can really add value and with it meet and exceed our cash flow and profitability targets. Over the last year, we have made a number of changes that is positively impacting our financials.

[Peter Caldini, President at Establishment Labs Holdings]

We reduced our operating expenses by $12,500,000 in 2024, while at the same time standing up a significant commercial operation in The United States. We have rightsized the global organization, eliminating headcount by more than 30% in some areas and streamline departments to ensure greater alignment and efficiencies. We are focused not only on reducing costs, but also improving our overall return on investment. In preparing for The U. S, we built a world class sales and marketing organization and have invested meaningfully in building inventory to support our launch.

[Peter Caldini, President at Establishment Labs Holdings]

We've been able to fund a good portion of this by reducing corporate costs and fighting efficiency across the organization. Among the changes we made is closing B15, our first and smallest manufacturing facility. This is in part reflected with the stronger gross margins we see in the fourth quarter. We have also made changes to better align our commercial and marketing organizations. We have reallocated resources to better performing initiatives and implemented better processes to ensure that we deliver on our financial commitments.

[Peter Caldini, President at Establishment Labs Holdings]

Recently, we completed the acquisition of our distributor, Benelux. With our long term partner in the region retiring, we took the opportunity to leverage the infrastructure we already have in place with our European distribution center, Nontwerp, to achieve meaningful synergies over time. As we look out to 2025, these efforts will continue in earnest. Raj will provide details on our financial targets for the year in a moment, but as a company, we are very focused on being EBITDA positive by the end of the year and cash flow positive next year. Our Board and the management team are aggressively focused on these targets and we will continue to do what's necessary to achieve them.

[Peter Caldini, President at Establishment Labs Holdings]

I look forward to reporting on our progress over the coming quarters. I now turn the call over to Raj.

[Raj Denhoy, CFO at Establishment Labs Holdings]

Thank you, Peter. Total revenue for the fourth quarter was $44,500,000 an increase of 41% from the year ago period. Foreign exchange reduced sales by approximately two percentage points in the quarter. From a regional perspective, sales in Europe, Middle East and Africa were approximately 38% of the global total, Asia Pacific 30 5 Percent, Latin America 18 Percent and North America was 9%. As noted previously, North American sales included $3,300,000 of Motiva sales in The United States.

[Raj Denhoy, CFO at Establishment Labs Holdings]

Our gross profit for the fourth quarter was $30,500,000 or 68.5 percent of revenue compared to $20,600,000 or 65.2% of revenue for the same period in 2023. The gross profit in the fourth quarter was positively impacted by higher production volumes, the decommissioning of our B15 manufacturing site and the early contribution of sales in The U. S. We expect this number to continue to improve as we ramp sales in The United States. SG and A expense for the fourth quarter increased approximately $7,100,000 to $44,000,000 This compared to $36,900,000 in the fourth quarter of twenty twenty three.

[Raj Denhoy, CFO at Establishment Labs Holdings]

The increase is due to the ramp up of commercial activity in United States following approval of Motiva Implants in late September as well as the operating expenses in the Benelux subsidiary we acquired in the fourth quarter. R and D expenses for the fourth quarter declined approximately $700,000 from the same quarter a year ago to $5,100,000 The increase in operating expenses in the fourth quarter was primarily the result of the increased investments in our U. S. Operations. These were offset by the cost reduction initiatives we undertook in the second half of twenty twenty three and which continued into 2024.

[Raj Denhoy, CFO at Establishment Labs Holdings]

Total operating expenses for the fourth quarter increased approximately $6,400,000 from the year ago period. Net loss from operations for the fourth quarter was $18,700,000 compared to a net loss of $22,100,000 in the same period in 2023. Adjusted EBITDA was a loss of $13,100,000 in the quarter compared to a loss of $17,400,000 in the fourth quarter of last year. We have taken tangible steps to reduce spending over the recent quarters as we have reduced our operating loss meaningfully even as we increased spending on the launch of Motif in The United States. Overall for 2024, operating expenses declined approximately $12,500,000 from 2023, despite our investments in The United States, and our EBITDA loss improved significantly to $28,200,000 from $47,000,000 in 2023.

[Raj Denhoy, CFO at Establishment Labs Holdings]

Our cash position on December 31 was $90,300,000 This compared to $39,700,000 at the end of the third quarter. The end of the year balance includes the proceeds of our registered direct offering in November 7 and the proceeds from the tranche of our credit facility that became available on U. S. Motiva approval. We have one additional tranche available in our credit facility for $25,000,000 during our total accessible cash balance at approximately $115,000,000 Our cash before financing in the fourth quarter was $22,600,000 The fourth quarter as well as the first quarter will be the highest for us in terms of cash use as we're seeing the investment in The United States commercial efforts as well as the increase in inventory need to support the strong demand we are seeing for our U.

[Raj Denhoy, CFO at Establishment Labs Holdings]

S. Launch. Our cash will improve meaningfully as the year progresses and we leverage these investments against higher sales in The United States. As our revenue scales, the business should start generating substantial cash flow and we believe we will reach cash flow breakeven in 2026. Our initial revenue guidance for 2025 is $2.00 $5,000,000 to $210,000,000 representing growth of 23% to 26%.

[Raj Denhoy, CFO at Establishment Labs Holdings]

Our expectation remains for our OUS business to grow in the mid single digits on an underlying basis. Before currency remains volatile, at current exchange rates, we expect revenue outside The United States to be approximately $170,000,000 to $175,000,000 Currency is expected to negatively impact 2025 reported sales results by approximately $2,000,000 to $3,000,000 We continue to expect at least $35,000,000 in U. S. Revenue in 2025. Gross margins in 2025 should be approximately 200 to 300 basis points higher on an underlying basis.

[Raj Denhoy, CFO at Establishment Labs Holdings]

This increase is being driven by the higher selling prices in The U. S. And with our other new product launches. We remain very focused on managing operating expenses and we expect total operating expenses will be approximately $45,000,000 to $46,000,000 per quarter, including approximately $6,000,000 to $7,000,000 of noncash expenses. This represents a step up in operating expenses for The U.

[Raj Denhoy, CFO at Establishment Labs Holdings]

S. Offset by continued efficiencies in our core business. We are on track to be positive in the second half of twenty twenty five. I will now turn the call back to Juan Jose.

[Juan Jose Quiros, Founder, CEO & Executive Director at Establishment Labs Holdings]

Thank you, Raj. As we communicated earlier this year, I am retiring from my position as CEO of Establishment Labs effective March 1. As the founder of this company more than twenty years ago, it was not an easy decision to step aside, but it was the right one. And as one of the largest shareholders of the company, I look forward to our bright future. However, I will continue to be involved with Establishment Labs in the things I love and I am best at, creating value through innovative concepts, overseeing the technology development and interacting with the surgeon community to promote these innovations while telling the amazing story of Establishment Labs.

[Juan Jose Quiros, Founder, CEO & Executive Director at Establishment Labs Holdings]

I am not going anywhere. In fact, later this week, we have another delegation of U. S. Surgeons coming to Costa Rica, and I will be hosting them at our Sullyum Innovation Center. I will also be at the American Society of Plastic Surgeons meeting in Austin next month, hosting several events with KOLs and many other meetings and events this year.

[Juan Jose Quiros, Founder, CEO & Executive Director at Establishment Labs Holdings]

This is an evolution for me into a new role at Establishment Labs. I like to call it the Chief Evangelist. We have accomplished an enormous amount over the past twenty years. We have transformed the breast aesthetics and reconstruction industry and dramatically reduced the rates of device related complications. We have brought key innovations to market like our proprietary low inflammatory smooth silk surface, micro transponder technologies and biosensors like Zen, the first and only ergonomic breast implant, FLORA, the first commercial breast tissue expander that allows for MRIs, next generation super silicones and now our minimally invasive platform in breast tissue preservation with Mian Preserve.

[Juan Jose Quiros, Founder, CEO & Executive Director at Establishment Labs Holdings]

At the surgical center in Ursulayom, we are designing and teaching the surgical techniques to simplify the adoption of minimally invasive and breast tissue preservation. We have scaled our manufacturing to where we can produce over 1,000,000 implants a year. We have established sales and distribution in over 90 countries. The track record of less than one percent device related complications with the over 4,000,000 devices we have sold have had an enormous impact on the lives of women in every corner of the globe, including The U. S.

[Juan Jose Quiros, Founder, CEO & Executive Director at Establishment Labs Holdings]

And China. The next level for us as a company, however, is to build on this foundation of innovation in an efficient and profitable way. And so, I decided to create space to bring someone in with deep experience scaling companies globally to profitability. While the Board is doing a market check, I think Peter Cialdini will do a wonderful job as interim CEO and could certainly handle the role on a permanent basis as well. I will now turn the call over to the operator for your questions.

[Operator]

Thank you. We'll now be conducting a question and answer session. Our first question is from Anthony Petrone with Mizuho Group. Please proceed with your question.

[Anthony Petrone, Managing Director at Mizuho Financial Group]

Thank you. And first, JJ, good luck into the transition and obviously congratulations on building a great organization and Pete good luck as interim and through the transitional process. Maybe first to go into the dynamics on The U. S. Motiva launch, couple of questions there And I have a quick follow-up.

[Anthony Petrone, Managing Director at Mizuho Financial Group]

Maybe just an update on how many accounts you're in. I think the number exiting last year was around 500. JJ, you gave some good color on ordering patterns here through February. I'm just wondering how that matches up in terms of total live accounts in The U. S?

[Anthony Petrone, Managing Director at Mizuho Financial Group]

And then when you think about the $35,000,000 guide, wondering if FDA clearance of Ergonomics two is baked into that number? And I have one quick follow-up.

[Juan Jose Quiros, Founder, CEO & Executive Director at Establishment Labs Holdings]

Yes. Thank you, Anthony. And yes, we're beyond happy with what we are seeing in the market with The U. S. Launch.

[Juan Jose Quiros, Founder, CEO & Executive Director at Establishment Labs Holdings]

And some of the color that we gave today is particularly important because we have six fifty accounts that have been fully onboarded and out of those four fifty have already placed orders and almost 90% of them have been reordering. And when you look at those that have not ordered yet, those are accounts that we have recently onboarded. So, if you add to that that we are signing up an average of five accounts per day, it gives you how this is going to scale up over the next few quarters. Remember, accounts that begin with Motiva doesn't mean they'll start using Motiva on day one, it means they'll start offering Motiva to their patients in their consultations after that. So they may be booking surgeries that are weeks away or sometimes months away.

[Juan Jose Quiros, Founder, CEO & Executive Director at Establishment Labs Holdings]

And the important thing for us at this point is to be focusing on the two things that matter, continuing to add new accounts, but now it also shifts the focus as well to the reordering patterns. And when we look at some of our largest accounts to date, their reordering patterns is exactly what we want to see. On your other question, our $35,000,000 does not include any new approval in The United States.

[Anthony Petrone, Managing Director at Mizuho Financial Group]

That's helpful. And a quick follow-up would just be maybe a recap on the macro front around the world. It sounds like we're still not quite out of the woods in terms of aesthetics, but there's some signs of green shoots. So maybe just the backdrop on aesthetics, key regions, U. S, China and Brazil?

[Anthony Petrone, Managing Director at Mizuho Financial Group]

Thanks again.

[Juan Jose Quiros, Founder, CEO & Executive Director at Establishment Labs Holdings]

Yes. I think it's important to realize that there are still macroeconomic pressures. But when we think about Latin America, we're not expecting growth from Latin America this year. We are also seeing very good signs that the situation is no longer deteriorating in Latin America. We already saw that in Q4.

[Juan Jose Quiros, Founder, CEO & Executive Director at Establishment Labs Holdings]

And

[Juan Jose Quiros, Founder, CEO & Executive Director at Establishment Labs Holdings]

as

[Juan Jose Quiros, Founder, CEO & Executive Director at Establishment Labs Holdings]

we look into EMEA and APAC, that's where the growth will come from. But we've guided, I think, in a very conservative way to about mid single digits. And that does not take into account any potential contributions from new regulatory approvals or launches like Preserve. So I think we're in a good place for a year of growth. And even though there will be macro pressures in different areas, I think we have enough evidence to feel that what we've said is totally achievable.

[Anthony Petrone, Managing Director at Mizuho Financial Group]

Thank you.

[Operator]

Our next question is from Alan Gong with JPMorgan.

[Allen Gong, Vice President at JP Morgan]

Hi, team. Thanks for the question. Just to start off with one on The U. S. Launch, it definitely seems as though you've got good momentum and you provided really good color on kind of the order rate daily basis.

[Allen Gong, Vice President at JP Morgan]

But just doing some napkin math and fully understanding that it's not quite that straightforward to get to actual revenues, but it looks as though your momentum so far in January and February already implies that the three point no, the $5,000,000 in first quarter looks like it could be really, really conservative given that the just the average daily orders you've seen so far. So why was $5,000,000 the right target to start off the year and kind of what are you assuming in March?

[Raj Denhoy, CFO at Establishment Labs Holdings]

Alan, yes, thanks for the question. I guess for us it's still early in the launch, right? So we had approval late September as you know, we launched in October, the things are going exceedingly well as one of the day described with the order numbers that we're seeing and how it's ramping. We'd agree with you, right, that the numbers we've given could look conservative, but it's still early in the launch. So we want to give ourselves some room.

[Raj Denhoy, CFO at Establishment Labs Holdings]

And again, so far everything is tracking, but we want to give ourselves a little bit of time to see how things develop.

[Allen Gong, Vice President at JP Morgan]

Got it. Okay. And then when we think about kind of the trajectory of your operating expense, right, you provided the kind of quarterly value that you're kind of expecting it to fall into. But when we think about the fact that, you know, some of the big step up sequentially from third quarter into fourth quarter is to sort of stand up The U. S.

[Allen Gong, Vice President at JP Morgan]

Launch, you've reached that 40 rep target that you've kind of been talking about. How should we think about the trajectory of SG and A going forward given some of that spend should be one time in nature and arguably can come out of the model in maybe the back half

[Allen Gong, Vice President at JP Morgan]

of the year? Thank you.

[Raj Denhoy, CFO at Establishment Labs Holdings]

Well, I don't think you should look at it as one time in nature, right? So we have hired salespeople, we've established a U. S.

[Raj Denhoy, CFO at Establishment Labs Holdings]

Commercial operation, that infrastructure is now in place, right. And as you move through the year, the leverage you'll see in the model is as we leverage that. And so the necessity to add on top of that will be opportunistic in our part, and we're seeing really strong demand in The U. S. And so we could add more salespeople as the year goes on, but there is not a necessity to add a lot more to that sales base.

[Raj Denhoy, CFO at Establishment Labs Holdings]

And so you should see it sort of stabilize and then frankly it should be at a similar rate. Again, there will be fluctuations quarter in and quarter out, but it should move much over the course of the year. And that's really how you start to get the leverage as you move through the year and the top line really starts to show this momentum we have in The United States.

[Operator]

Our next question is from Josh Jennings with TD Cowen.

[Joshua Jennings, Managing Director at TD Cowen]

Hi, good afternoon. Thanks for taking the questions. And Juan Jose, congratulations on quite the ride. And it's great to hear that it will continue with your continued active involvement with the company. Wanted to just ask, I know you're not providing details on the FEMTECH minimally invasive portfolio regulatory pathway, but was hoping you may just help us think about what steps are required prior to those pathways being fully developed in The U.

[Joshua Jennings, Managing Director at TD Cowen]

S. And China for EMEA and for Preserve? If you can just help us think about what boxes need to be checked before that's finalized?

[Juan Jose Quiros, Founder, CEO & Executive Director at Establishment Labs Holdings]

Yes. Thanks, Josh. I think we've been trying to give as much color as possible in how we're going to bring the next generation of innovation into The U. S. And one of the things we've been saying is that really with the approval of the Motiva smooth silk round and the Motiva smooth silk ergonomics, it's already a different generation of implants from what you had available in The United States.

[Juan Jose Quiros, Founder, CEO & Executive Director at Establishment Labs Holdings]

Now, one of the things we talked about today is the beginning of the process for the registration of tools necessary for press survey. And I think that's very exciting, of course, given the excitement that breast tissue preservation is already having globally. If you look at what many of the surgeons even here in The United States are saying about breast tissue preservation, they're already very happy to put the implant above the muscle, saving the pectoralis muscle when and if possible. But there's a whole shift towards this movement we pioneered. So definitely having that process ongoing is going to help us with a potential launch of Avey in The U.

[Juan Jose Quiros, Founder, CEO & Executive Director at Establishment Labs Holdings]

S. On top of that, you have the potential approval of the reconstruction indication for 2026. And remember, we recognize revenue at a much higher price when it comes to the reconstruction market, not only for Flora, but eventually when approved for Motiva implants. Beyond that, there is the Ergonomics two platform and that's what allows for FORMEA, which is basically those injectable implants that are done minimally invasive. So, it really is about a super cycle of innovation.

[Juan Jose Quiros, Founder, CEO & Executive Director at Establishment Labs Holdings]

So, you should think about like that you're going to be seeing approvals and launches of innovative, real differentiated products in The U. S. Market in 2026, '20 '20 '7 and 2028. So, we're not giving the exact dates, but I think you can be sure that you will be seeing every year an important development in terms of innovation from us.

[Joshua Jennings, Managing Director at TD Cowen]

Excellent. And maybe the follow-up kind of it involves this pipeline, but prior to some of the macro turmoil, your team had laid out this path to kind of medium to long range plan path to $500,000,000 in revenue and was hoping to just I know that's not set in stone currently, but maybe just talk about your confidence in that March to $500,000,000 in revenue from here? Thanks a lot.

[Juan Jose Quiros, Founder, CEO & Executive Director at Establishment Labs Holdings]

Yes. I think in terms of that in the second half of 'twenty three and pretty much a big part of 2024, what we saw is all these macro pressures have an effect in aesthetics overall, both in The United States and also in The U. S. But I think aesthetics is really showing signs of resilience. We're already seeing good signs in APAC, EMEA, and Latin America, I think, is the one lagging behind in that return to growth.

[Juan Jose Quiros, Founder, CEO & Executive Director at Establishment Labs Holdings]

But for us, with The U. S. On board and all the dynamics that we are seeing, that rich innovation pipeline, I think it becomes, first of all, going back to the type of strong growth that this company had been doing prior to that period. So already this year, you're at 25% at the midpoint and with possibilities for doing even more. Beyond that, there's an important thing regarding our ability to get to that number eventually as a profitable company.

[Juan Jose Quiros, Founder, CEO & Executive Director at Establishment Labs Holdings]

And already this quarter, you see our gross margins at 68.5%. So, it shows you how all the work that Pete has been doing in terms of rightsizing the company and all the efficiencies that we've been getting on top of selling our products at higher prices with higher revenue in The U. S. And also into China. And as you go into those innovations, remember, Preserve kind of like is in the midpoint between Motiva Implants and EMEA.

[Juan Jose Quiros, Founder, CEO & Executive Director at Establishment Labs Holdings]

So that also should add a lot of good high quality revenue for the company. So I think that's the difference, Josh, is that in the past, we were just zeroed into, let's get to $500,000,000 and now we're like, well, we're going to get there as a profitable company.

[Joshua Jennings, Managing Director at TD Cowen]

Excellent. Thanks, Monozet.

[Operator]

Our next question is from Marie Thibault with BTIG.

[Marie Thibault, Managing Director at BTIG]

Just wanted to say good luck to you on your next phase. And Peter, it's nice to be working with you here going forward. Wanted to ask a question here about OUS revenue really. And when I think about this mid single digit guide for OUS, it appears that's going to include that $8,000,000 to $10,000,000 in EMEA revenue. If I back that out, assuming of course you had some EMEA revenue in 2024, it looks like all you're needing to achieve is low single digit growth OUS this year.

[Marie Thibault, Managing Director at BTIG]

Is that the right way to think about it? And if so, is there anything you can do to help us kind of think about the cadence throughout the year, things to think about in terms of seasonality, China distributor ordering, that sort of thing?

[Raj Denhoy, CFO at Establishment Labs Holdings]

Yes, Marie, thanks for the question. So, the other thing is, we did have the

[Raj Denhoy, CFO at Establishment Labs Holdings]

year that we turned to last year. The $10,000,000 we've given is the first time we provided that number, so it could give you some confidence that we're seeing the demand for that product. It's really about 2025. When you do expect the gradual recovery in the fourth year. It's not as

[Raj Denhoy, CFO at Establishment Labs Holdings]

expected next year. The other important dynamic to really consider in your outlook is that China for us, so 2024 was a year where we had sales into that market in China. That distributor has now set up their distribution network into China. We're not expecting much reordering in the first half of this year, but that will recover in the second half and we'll start to see demand match kind of end market dynamics in China. We'll see a little bit of currency in the first half of the year.

[Raj Denhoy, CFO at Establishment Labs Holdings]

But overall, you're correct. I mean, we should see growth over the course of the year gradually recover and we provide I think a pretty conservative start to the year in terms of what's needed to reach our numbers.

[Marie Thibault, Managing Director at BTIG]

Okay. Conservative start to the year, that's good to hear. And then maybe my second question here on some of the EBITDA outlook you've given as well as the cash flow. Just want to quickly clarify, I think I heard for 2026, you're aiming for I think I heard both cash flow breakeven or cash flow positive. Can you just clarify which one that is?

[Marie Thibault, Managing Director at BTIG]

And then should we think about the EBITDA trajectory throughout the year very similar to what you talked about for the cash burn trajectory in terms of a bit higher in Q1 and then improving meaningfully throughout the year? Thanks for taking the questions.

[Raj Denhoy, CFO at Establishment Labs Holdings]

Yes. So we've talked about achieving a quarter of EBITDA positive, getting to EBITDA positive here in 2025 and then a similar approximate threshold to cash flow positive in 2026. In terms of your question about EBITDA and cash flow, it is similar, right? So as the year progresses, we expect the cash use and really EBITDA loss in the first quarter to be pretty similar to what it was in the fourth quarter and again reflecting that stepping up of the commercial efforts in The United States and the inventory needed to support those efforts. And then as the year goes on, you start to see the leverage and we do again expect to achieve EBITDA positive in the second half of the year.

[Raj Denhoy, CFO at Establishment Labs Holdings]

And as you move into 2026, those dynamics continue when

[Raj Denhoy, CFO at Establishment Labs Holdings]

you cross over into cash flow positive.

[Operator]

Our next question is from Joanne Wuensch with Citibank. Please proceed with your question.

[Joanne Wuensch., Managing Director at Citi]

Good afternoon. Thank you for taking the question. It sounds like there's some good early momentum in the launch. And I'm curious, what kind of positions are adopting Motiva? And what kind of patients are they targeting as the best patients for it?

[Joanne Wuensch., Managing Director at Citi]

And I'll put my second question out at the same time, which is it sounds like you've started the year with about 40 active sales reps, but you're looking to expand it throughout 2025. How do you think about exiting 2025 in terms of sales reps? Thanks.

[Juan Jose Quiros, Founder, CEO & Executive Director at Establishment Labs Holdings]

Yes. Thank you, Joanne. I think it's really important to see that The U. S. Market has been starving for innovation for last two decades.

[Juan Jose Quiros, Founder, CEO & Executive Director at Establishment Labs Holdings]

So, of course, one of the things that we are seeing is the excitement around the brand. Over 60 press articles, hundreds of social media posts from surgeons talking about having access to this amazing technology, having the ability to put this implant above the muscle safely, reducing device related complications and all of it. We've had over 1,800,000,000 impressions in social media and that has been organic. So, when we see that, what we have to do as a company is to make sure that women who were in the consideration phase for a breast augmentation, but had not made their decision based on safety or is am I going to have an unnatural result are receiving the type of messaging that they need to cross over and make it to their clinic. And that's something that is really important to see.

[Juan Jose Quiros, Founder, CEO & Executive Director at Establishment Labs Holdings]

We talked about the celebrity campaign that we have upcoming and that's also going to make a difference because for the last two decades, aesthetic companies have not been really exclusively involved with the plastic surgeon and we are. So, what type of patients are they seeing? Patients who are excited about this technology and those come from different age groups, but they're really going in there because of the innovation, the safety and definitely when we look at number of sales reps that we have today, we have what it takes. We will add probably selectively in big metro areas as the year progresses, But we have what it takes now.

[Joanne Wuensch., Managing Director at Citi]

Thank you.

[Operator]

Our next question is from Matt Taylor with Jefferies.

[Matt Taylor, Managing Director at Jefferies & Company Inc]

Hey guys, thanks for taking the question. I wanted to start with one on just on Motiva and I was wondering what you're seeing here early. It's kind of related to the types of surgeons, but which incumbent do

[Matt Taylor, Managing Director at Jefferies & Company Inc]

you think it's going to

[Matt Taylor, Managing Director at Jefferies & Company Inc]

be easier to take share from in these new markets? Is there one that's easier than the other at this point?

[Juan Jose Quiros, Founder, CEO & Executive Director at Establishment Labs Holdings]

In The United States, I think you've seen a market leader AbbVie with Aesthetics, taking about 15% of the market and then Johnson and Johnson with Mentor in second place. And I think we're getting market share from everyone who believes in innovation as a plastic surgeon. So they are the ones doing the first mover. But later on, we'll see people coming from all places. We're not selling our implants at a price point that attacks the low price market.

[Juan Jose Quiros, Founder, CEO & Executive Director at Establishment Labs Holdings]

So that's probably a place where we're not heading at this point. But definitely what we are seeing is that, for instance, when you look at ergonomics, we were not expecting the share of ergonomics in our total sales to be so high at this point. And ergonomics is a more expensive product, truly differentiated from everything else that you see in the market. So those are the things that we'd like to see. Beyond that, I think over time, we're going to be taking market share from everyone.

[Matt Taylor, Managing Director at Jefferies & Company Inc]

And can I ask a follow-up on Mieux? I guess, I was just wondering your current thinking when you first introduced the concept years ago and had done market research, you talked about the potential for it to kind of double the TAM. I know you've expressed in Europe, you're seeing kind of half those patients so far, say they weren't really in the market for augmentation until they saw this. So what do you think now in terms of what MIA could do for TAM expansion?

[Juan Jose Quiros, Founder, CEO & Executive Director at Establishment Labs Holdings]

I think we remain very confident with that. I think it just happens over a longer period of time. The entire breast augmentation sector hasn't seen much growth in the last fifteen years. So having this real market expansion taking place over the next five to ten years is going to make a big difference. And it happens at a higher price point, by the way.

[Juan Jose Quiros, Founder, CEO & Executive Director at Establishment Labs Holdings]

So all of that is, of course, a positive. But again, MIA takes longer to develop. When you look at Preserve, think about like the fifty percent of patients that came in for interested in MIA, but eventually they're not a good MIA patient. Then with Preserve and the potential launch of Preserve in different geographies, what we can do is provide to MEA interested patients who are not good candidates an option that is much superior and closer to what they were expecting. So I think the marriage of Mia and Preserve, it's a powerful one because not only we're working on the real market expansion piece, but also with Preserve, we're attacking the day to day needs of the plastic surgeon and that's why it can be so impactful.

[Operator]

Our next question is from Mason Currico with Stephens Inc.

[Harrison Parsons, Research Associate at Stephens Inc]

Hey, this is Harrison on for Mason. Thanks for taking the questions. I wanted to ask about what is baked in from U. S. Motiva revenue here in 2025.

[Harrison Parsons, Research Associate at Stephens Inc]

Could you specify how many accounts and orders per day and sales reps you expect to end the year with?

[Raj Denhoy, CFO at Establishment Labs Holdings]

Yes. Hey, Harrison. So, we have given the number $35,000,000 right, which we expect to meet or exceed we have noted. In terms of the number of accounts and the pace of accounts, we're not going to provide that level of detail in our forecast. Again, given some of the metrics Lon Jose described, we're seeing very strong growth, we're seeing very strong development in those numbers.

[Raj Denhoy, CFO at Establishment Labs Holdings]

Nothing we've seen thus far has given us any pause in endorsing that kind of outlook. In terms of sales reps, we've noted as well that the 40 reps we have in the field is the team we need. We can drive towards those numbers and more with that team. We'll be selective as the year goes on if we see certain markets where we need to add a sales rep or divide territories and those types of things, we will do that to keep things healthy. But again, we don't need to do much more to achieve the numbers that we've described.

[Harrison Parsons, Research Associate at Stephens Inc]

Got it. Yes, that makes sense. And then a quick follow-up here. I was wondering or I just wanted to confirm, have you completely resolved all the supply challenges for Motiva? And was there any lingering impact we should expect in the first quarter?

[Juan Jose Quiros, Founder, CEO & Executive Director at Establishment Labs Holdings]

Yes. So, thanks, Harrison. We've as soon as we got the FDA approval, we've actually ramped up our capacity. We've added a third shift. So, that enabled us to provide the amount of inventory that we needed for the launch in The U.

[Juan Jose Quiros, Founder, CEO & Executive Director at Establishment Labs Holdings]

S. And we don't expect to have that any of those issues going into Q1 and beyond.

[Harrison Parsons, Research Associate at Stephens Inc]

Perfect. I'll leave it there. Thank you.

[Operator]

Thank you. There are no further questions at this time. I would like to hand the floor back over to Juan Jose Chacon Quiros for any closing comments.

[Juan Jose Quiros, Founder, CEO & Executive Director at Establishment Labs Holdings]

After '23 earnings call, I did want to take the opportunity to thank all of the analysts who've been covering us for all these years and all the banks that have worked with us. I really see it as one of the great points of my career. And I want to thank you for joining us on today's call. We will be at several conferences over the next few weeks, including City's MedTech and Life Sciences Access Day and the Cowen Annual Healthcare Conference. We also have a large presence at the upcoming Aesthetic Society meeting in Austin, Texas, and we look forward to seeing many of you at these events.

[Juan Jose Quiros, Founder, CEO & Executive Director at Establishment Labs Holdings]

We wish everyone continued good health and happiness.

[Operator]

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

Participants

Executives

• Raj Denhoy, CFO
• Juan Jose Quiros, Founder, CEO & Executive Director
• Peter Caldini, President

Analysts

• Anthony Petrone, Managing Director at Mizuho Financial Group
• Allen Gong, Vice President at JP Morgan
• Joshua Jennings, Managing Director at TD Cowen
• Marie Thibault, Managing Director at BTIG
• Joanne Wuensch., Managing Director at Citi
• Matt Taylor, Managing Director at Jefferies & Company Inc
• Harrison Parsons, Research Associate at Stephens Inc