Establishment Labs Holdings Inc. Q3 FY2025 Earnings Call

Thank you, operator, and thank you, everyone, for joining us. With me today is Peter Caldini, 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 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 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 EBITDA, which we disclose on an adjusted EBITDA basis. 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 5, 2025. 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's my pleasure to turn the call over to Peter.

Good morning to everyone and thank you for joining today. Q3 2025 was a standout quarter for Establishment Labs. We grew global revenue 34% with total revenue of $53.8 million, including $11.9 million in the U.S. We also exceeded a 70% gross profit margin for the first time, coming in at 70.1%, and we achieved the first quarter of positive EBITDA in our company's history with $1.2 million in Q3. Getting to positive EBITDA ahead of the fourth quarter was an important goal for our company, and we now turn our focus towards reaching cash flow positive next year. While optimizing our business, we had meaningful revenue growth in the U.S. and our other direct markets. I'd like to thank all the employees that made this a priority and a reality, and the sense of accomplishment has all our employees eager for our next milestone of cash flow positive. The U.S. business is our most important growth segment right now, and it continues to outperform. Q3 revenue was $11.9 million, up 16% sequentially in what is a seasonally slower quarter in breast procedures. Markets can be down 20% to 30% sequentially in Q3, making our results all the more impressive. For the first three quarters, U.S. revenue totaled $28.3 million, so we are clearly going to do quite a bit better than the $40 million we committed to last quarter. We are expecting considerable acceleration of the U.S. business in Q4, and we are already seeing a significant shift from Q3. But as it's our first full Q4, we are going to be prudent by raising our 2025 revenue guidance to exceed $210 million, where we previously had a range of $208 million to $212 million. Most interesting is what these results imply for 2026 because we should finish 2025 at approximately a 20% share in the U.S. breast augmentation market, and the momentum has not slowed. While 2026 will be a continuation of our growth in the breast augmentation segment, we are looking forward to our approval in breast reconstruction, which is similar in market size to augmentation, and we are preparing for the U.S. launch in this segment. Outside the U.S., we saw good growth and remain on track for single-digit growth this year. Accelerating growth in our direct markets has been a priority, and we are seeing the benefits of the changes we have implemented. Excluding the benefit of currency and the acquisition of our Benelux distributor, our European direct market sales increased approximately 20% this quarter over Q3 2024. In our distributor markets, Asia-Pac had a strong rebound from the second quarter as the ordering cadence normalized. Our U.S. business is performing at a very high level. The number of surgeons using Motiva continues to increase. We now have over 1,300 surgeons using Motiva, including some of the highest volume and best-known practices in the country, and we are attracting additional waves of adopters as the benefits of Motiva in both clinical and commercial practice resonate. We are as focused on surgeons making Motiva their primary implant of choice as we are at attracting new surgeons to our business. We continue to bring groups of surgeons down to Costa Rica for training and surgery. Over 50 surgeons attended our September and October classes, and more than 250 surgeons have come to Costa Rica since launch. We are expecting a similar pace in 2026 with seven sessions already scheduled; there is no shortage of surgeons that want to make the trip. Surgeons learn about the science behind our implant technology, see the best-in-class standards employed throughout our facilities and experience our commitment to driving innovation in the category, including discussing and offering input to our R&D pipeline. While some surgeons come already enthused about Establishment Labs, almost every surgeon returns to their practice as a fan of our company. Social media continues to play an important role as plastic surgeons advocate Motiva to their audiences. Plastic surgeons consistently tell us that if they offer patients a choice between Motiva and legacy implants, it’s almost unanimous that patients will choose Motiva. This puts us in a position of strength, and we win if we convince plastic surgeons to give patients a choice. Every legacy brand has a much more challenging proposition; they have to convince plastic surgeons to offer only their products. Championing women's health and advocating for patients' choice should accelerate us to take a majority of the U.S. market over the next several years. In Q3, we conducted a survey of surgeons that are early adopters and advocates of Motiva to understand the impact of Motiva on their practices. While industry sources point to a market that has not experienced much growth, the practices offering Motiva in our survey increased their procedures by 14.6% so far this year. Surgeons tell us that patients are coming in and asking for Motiva by name, and we hear from surgeons as well that many women are entering the category because of Motiva. We regularly hear that women are abandoning their warranty of their legacy implants and choosing to pay out of pocket for Motiva. As many of you know, this is incredibly rare in healthcare, but it's happening now as our entry is changing the industry. There isn't just one single reason for this. Some women cite the improved safety profile offered by Motiva and others cite the benefits of having an above-the-muscle procedure without compromise. And yet for others, it's the increased awareness from our marketing efforts. Whatever the reason, it's clear the conversation around breast augmentation is changing. This is a powerful combination. We are not only capturing share, but we are expanding and accelerating the market for breast augmentation. A major driver for market expansion is our minimally invasive portfolio. As we have noted, we trained a group of U.S. plastic surgeons in July as part of our early experience group for Preserve to gain insights prior to going to market more broadly. Preserve is a breast tissue-preserving procedure that can be done without the need for general anesthesia, offering smaller scars and fast recovery. Preserve can be used in a wide cross-section of cases surgeons see in their day-to-day practices. As these surgeons have taken Preserve back to their practices and started to perform procedures, the feedback has been very positive, not only from surgeons but also from the women who have received the procedures. I encourage you to seek out the videos and testimonials that have been posted on our social media to see the early responses. Surgeons have embraced the fundamental changes Preserve brings to breast augmentation. It is not just a new way to do an existing procedure. It is an entirely new concept in how a breast procedure can be done. Preserve has the potential to drive category growth and improve the economics for surgeons. We are seeing as much as a 40% price premium to a standard breast augmentation for these early experienced surgeons. The group of surgeons that came for Preserve training where each supplied a small number of kits in August. A majority of the kits we provided have been used, and surgeons consistently ask us for more to alleviate growing waitlists. From just our early experience launch, we would estimate that 300 Preserve cases have been performed in the U.S., and there are at least 100 women on waitlists around the country. Not unexpectedly, there is a groundswell of surgeons that have asked to be trained on Preserve, and we will begin these trainings in January. We have two such trainings planned for the first quarter alone and would expect a similar cadence throughout the year. In breast reconstruction, our Flora Tissue Expander is now in use at over 150 hospitals in the United States. This bodes well for our expected launch into reconstruction, and we remain on track to file our PMA supplement by the end of the year. We also remain on track for the approval of our small sizes in the U.S. in early 2026, and this should help accelerate growth both with new doctors as well as increasing the usage of our current doctors. Outside the U.S., excluding the benefit of our Benelux acquisition and currency, direct markets globally grew 15% versus last year. We believe this performance is well above the underlying market growth rates in these regions. In our Latin American direct markets, we continue to see stabilization in Brazil and strong growth in Argentina. European direct markets are being led by strong performances across the continent with standouts in the UK and Spain. The number of accounts in many of our direct countries continues to increase, a positive sign and a reflection of the increased focus on performance in direct markets. We are taking advantage of our strong growth in direct markets to make sure that the O-U.S. business as a whole is prime for growth. We are engaging with our distributor partners regularly. We are working to raise standards globally around payment terms, inventory forecast, and market share expectations. In our minimally invasive portfolio, Mia remains on track to achieve $8 million to $10 million in revenue in 2025, and Preserve continues to see good adoption in international markets. Surgeons globally are seeing the benefits of breast tissue preservation made possible by our minimally invasive platform. The successful rollout of Preserve and the continued growth of Mia has resulted in above-market growth and proves its potential for market expansion. Globally, we expect the portfolio of Mia and Preserve will exceed $30 million in 2026.

Thank you, Peter. Total revenue for the third quarter was $53.8 million, an increase of 33.7% from last year. Excluding the positive impact of foreign exchange in the quarter, growth would have been approximately 31.4%. Sales for Motiva in the United States were $11.9 million. On a geographic basis, sales in Europe, the Middle East, and Africa were 35.6% of the global total. We saw strong sales in our direct markets in the region, while sales to distributors were lower on the timing of orders. Sales in the United States were 22.1% of the global total. Latin America was 21.7% of sales. Brazil remained stable, and we saw strong growth in our other direct market in the region, Argentina, as well as from our distributors. Asia-Pacific was 20.6% of sales. Results in the quarter rebounded sharply from last quarter as expected orders from our distributors were realized. Sequential growth in the region was 46%. Our gross profit for the third quarter was $37.7 million or 70.1% of revenue, a 620 basis point increase compared to 63.9% of revenue last year and 130 basis points higher than the 68.8% in the second quarter of this year. This is the first time we have crossed a 70% gross margin, and the increase is primarily the result of the higher margin sales in the United States. We expect gross margins in 2025 will be approximately 300 basis points higher than in 2024. As it relates to tariffs, goods imported from Costa Rica to the United States are subject to duties. However, as we saw in Q3, we are managing their impact and do not meaningfully change our trajectory for gross margin improvements this year. SG&A expenses of $37.2 million were approximately $3.1 million higher than the third quarter of 2024. R&D expenses for the third quarter were $4.6 million. Total operating expenses for the third quarter increased approximately $2.9 million from the year-ago period to $41.7 million. Operating expenses have been approximately $45 million to $46 million on average per quarter, which is what we guided to at the start of the year and what we continue to expect. As we saw in this quarter and in the second quarter, there can be fluctuations based on the timing of expenses. Adjusted EBITDA was positive $1.2 million in the third quarter. This compared to a loss of $8.5 million in the second quarter and $12.1 million in the first quarter. This is our first EBITDA-positive quarter as a company, and there are a couple of things to highlight. While the improvement results are being supported by the strong sales and the higher gross profit in the United States, we have been very focused on managing our operating expenses. While operating expenses in the third quarter increased approximately $3 million from a year ago, they were down over $5 million from the third quarter of 2023. Over the time, we have invested significantly in our U.S. commercial operation and launched our minimally invasive portfolio. We were able to do this by finding efficiencies across all parts of the organization and making structural changes where needed. We expect EBITDA will continue to improve, including in the fourth quarter, and expect to remain EBITDA positive from here on. For 2026, we will continue to expand our commercial infrastructure in the United States. However, the investments we make overall as a company will be at a rate well below expected top-line growth. We've been investing with the expectation of global market leadership and have built an organization that can take full financial and commercial advantage as that occurs. Most of our spending in this regard has already happened. For example, the facilities we have today can produce more than half the world's implants. We expect revenue to grow more than 20% for at least several more years, and our business should start to show meaningful and increasing earnings in 2027 and beyond. Cash increased $16 million in the third quarter to $70.6 million from $54.6 million at the end of the second quarter. The increase was primarily the result of drawing the remaining $25 million tranche of our credit facility, offset by our operating cash use. Excluding the net proceeds, cash use would have been $8.5 million in the third quarter. This compares to $14.5 million in the second quarter and $21.2 million in the first quarter. We expect cash use to improve further in the fourth quarter and expect to reach cash flow positive in 2026 without the need for any further equity raises. Our credit facility is set to mature next year, and we are considering a number of refinancing options that could further reduce our cash use. We're also working to make the company eligible for inclusion in a number of indices, most notably the Russell. There are a number of things we can do to affect this, and we believe we will be eligible for future rebalancings. As Peter noted, we now expect our revenue in 2025 will exceed $210 million, an upward revision from our previous guidance of $208 million to $212 million. Our updated outlook represents growth of at least 26%. The U.S. remains a primary engine of growth this year. We have seen very strong results over the first three quarters of 2025, and this has continued into the fourth quarter. Our direct markets outside the U.S. are also doing well and demand globally for our products remains good. Gross margins are improving, and we are managing our operating expenses, which allowed us to achieve positive EBITDA a quarter early. We expect to see continued improvements in profitability and remain confident we'll reach cash flow positive in 2026.

Third quarter of 2025 was, in many ways, a turning point for our company. We achieved positive EBITDA for the first time, and we achieved this in a quarter where we grew revenue 34%. These results show that we can efficiently invest in and grow our business, and we will continue to do so. The next step is to achieve cash flow positive, which I am confident we will do next year. We expect our top-line growth to remain above 20% for the next several years, and our profitability should expand at a much faster pace. I am looking forward to having conversations with our shareholders about our increasing EPS and how we can keep that momentum going for the next 5 to 10 years. Operator, we're ready to take questions.

The first question comes from Anthony Petrone with Mizuho.

Congrats to the team all around here on strong execution. Maybe Pete and Raj, you could start with the comments on 2025 and just the implied outlook as we head into the end of the year. Just looking for some more inputs, puts and takes on the 4Q number, specifically, how should we think about O-U.S. trends? Obviously, there's strong momentum on the U.S. side, but maybe a little bit more detail on what we're thinking about for new account openings from here, Preserve uptake? And then lastly, just the EBITDA-positive, well ahead of expectations. How do you think about EBITDA trending from here just given the momentum on the U.S. side?

Yeah. Thanks for the question, Anthony. Clearly, a lot of momentum in the business heading into the fourth quarter. And as we noted, we're planning to exceed $210 million now for the year. And as it relates to the fourth quarter, the U.S. has quickly become our largest market, and we have a lot of momentum in the U.S. For us, though, we haven't yet seen a fourth quarter, right? And there are some nuanced elements in the fourth quarter around reconstruction and some of the holidays that make it difficult to provide an exact estimate. However, we have a lot of momentum, and we expect to meaningfully exceed the $40 million we previously provided. Outside the U.S., we also have a lot of momentum, specifically in direct markets where we're seeing very strong growth. In Europe, we were north of 20% in our direct markets this quarter. We have a really strong order book for the fourth quarter from our distributors. And so we're expecting a very strong finish to the year. I think importantly, that sets us up really well for 2026. The momentum we're carrying into the next year is a very favorable position for us.

The next question comes from Josh Jennings with TD Cowen.

Congratulations on arriving in the EBITDA positive era a little bit earlier than expected. Pete and Raj, I was hoping to just start on thinking about 2026 and the international business, but specifically China. Any updates just in terms of the outlook there and the distributor relationships and when reordering could start to kick in? Should we be expecting Q1 2026? Is there any chance that there could be some China orders in the fourth quarter?

Yes. So thank you, Josh. In terms of the O-U.S. markets, I think in general, we've seen stabilization for the most part across all the markets. Our focus going into this year was really driving growth in our direct markets, and I think we've been very successful in doing that. We have better economics and more upside potential in those markets. As Raj mentioned, we had 20% growth, following a quarter where we had 27% growth in our European markets. So we're gaining accounts. A lot of that growth is being fueled by Preserve, but we are experiencing very strong performance, and we'll continue to focus on that as we go into 2026. We also have good momentum in the fourth quarter and expect that to persist into next year. Regarding China, we're working closely with our partners there and have made progress from a sell-out standpoint, and we will keep you updated.

The next question comes from Allen Gong with JPMorgan.

I have a question about the broader market. When we observe some of your competitors in aesthetics, their body language seems more cautious about market dynamics, especially as we approach the fourth quarter. In contrast, your results and your confidence suggest that you're not experiencing that, so I would like to know if you are not seeing that weakness. Are you growing through it, or is there a reason why those challenges appear to be more specific to your company rather than affecting the broader market?

Yes. Thanks. First off, I mean, we can't really comment on their perspective on the market. I can just tell you how we're seeing it in the U.S. specific to breast aesthetics. I think we've created a lot of momentum in the marketplace, and I think what we mentioned in the prepared remarks regarding some accounts that have early adopters of Motiva is that we're seeing an increase in the number of procedures. So what we are seeing and as it relates to our business, we're seeing growth. We're very positive about the momentum we've been able to build in Q4, and that's just going to continue into next year.

The next question comes from Sam Eiber with BTIG.

Maybe I can shift over to the minimally invasive platforms. You talked about the $30 million in revenue for next year. Can you just help frame the contribution this year if there's any way to parse out Mia versus Preserve? And then what market development work needs to happen to get to that at least $30 million target for next year?

Yeah. Thanks, Sam. We're very pleased with the progress we're making with Preserve and the minimally invasive platform. Speaking specifically on Mia, we've doubled the number of accounts this year, and that was our goal. Then with Preserve, we're off to an outstanding start in Europe, and we're focusing primarily on the direct markets but also expanding it to some of our distributor markets. This momentum will continue into 2026. We mentioned also that in the U.S., we're going to be launching in the early part of next year. So we're looking at the end of the first quarter. There's already significant demand. We've seen that from the early experienced surgeons who are very excited. Once it's launched, I think it's going to ramp up quickly. So we're very happy with that platform and how it’s performing.

The next question comes from Joanne Wuensch with Citi.

This is Anthony filling in for Joanne. Could you provide some specifics or quantify your expectation for U.S. sales to significantly exceed $40 million this year?

Yeah, Anthony, as I tried to answer the first question, right, the fourth quarter, again, we are carrying a lot of momentum into the fourth quarter. We will do quite a bit better than the $40 million we previously talked about. However, it is the first time we've had a fourth quarter in the United States. There are some holidays and other elements to the quarter that will make it difficult to provide an exact estimate. Nevertheless, we are doing very well in the U.S., and all indicators are pointing in the right direction.

The next question comes from Mason Carrico with Stephens.

So reiterating the single-digit growth in international revenue, it seems like you're seeing strength across a handful of markets and stability in others. Are you willing to quantify how you’re at least preliminarily thinking about growth in the international market next year?

Yes. Mason, it's a good question. We haven't yet provided the 2026 outlook. But from a high-level standpoint, we're seeing a very good demand in our direct markets. It's been an area of focus for us, and we're seeing that play out now. We don't expect that momentum will slow. In addition, we expect further growth in our distributor markets. Overall, we're expecting our international markets to perform well, and combined with what we're seeing in the United States, we expect another year of very strong growth for the company.

Got it. Okay. And in terms of Motiva accounts in the U.S., what are you seeing in terms of trends among customers after adoption? How quickly are you seeing them ramp up? Is there an average amount of their practice they end up converting? Just any incremental detail you can provide there?

Yes. As we have mentioned before, the growth in the U.S. is really exceeding all our expectations. We've overdelivered on most of our internal KPIs. We continue to add additional accounts, and the utilization rates keep increasing, especially as many of the accounts complete their scheduling process. What also contributes significantly to the utilization and penetration is the number of patients entering the accounts specifically asking for Motiva. We’re experiencing exceptional growth in Q4, and we believe this is a pivotal moment for us moving forward.

The next question comes from Mike Matson with Needham & Company.

I wanted to get some clarification on the commentary around getting to 20% share exiting the year. So we had estimated that the U.S. augmentation market is around $600 million, so about $150 million a quarter, if you flatline it, and 20% of that would imply about $30 million. I mean, is that math reasonable or am I missing something? Maybe you mean like as of the very last day of the quarter, you'll be ramping through the quarter, you'll be at 20% as of the very tail end of the quarter or something like that?

Yes, Mike, I think just to level set, I think your expectation for the size of the market may be a little bit off. If you look at some of the data from the clinical societies, the market in the United States is estimated at approximately 300,000 procedures a year. Our ASPs, we've talked about are around $1,300, a little north of $1,300 per case. That puts you at a little bit below $400 million for the augmentation market. The reconstruction market is about the same size. So if you just consider the augmentation market, you're looking at approximately $390 million to $400 million. That is the market against which we expect to exit at about 20%.

Okay. So more like a $20 million number then.

But again, that's also an exit rate as we're leaving 2025 and heading into 2026.

Okay. All right, understand. And then just as far as the fourth quarter goes, how much visibility do you feel you have? I mean we're over a month into the quarter now, or I guess, sorry, two months into the quarter now. And then I know you have orders that you get. And so I don't know how much lead time there is between an order and a shipment and things like that.

We do. I mean, we do see the daily orders. We know the number of customers we have. So we have quite a bit of visibility on how the business is tracking. As we've noted, there's a lot of momentum right now. Those metrics all continue to go higher. As we’re leaving the third quarter and entering the fourth quarter, there’s a lot of acceleration in this business. Again, it's our first fourth quarter as a company in the United States, so we want to be prudent in how we set the midpoint of where we think we will end up. But we're experiencing outstanding momentum, and we’re anticipating a very strong finish to the year.

The next question comes from Matthew Taylor with Jefferies.

This is Matt on behalf of Matt Taylor. I wanted to quickly ask about 2026. Assuming you finish 2025 with approximately 20% market share, as you look at your strategy for next year, do you foresee your expansion primarily through deepening relationships with existing accounts or by acquiring new ones?

Yes. I mean, as we mentioned before, we’re exiting 2025 with tremendous momentum. We’ll keep adding existing accounts, and the utilization rates are continuing to pick up. This momentum will continue into next year. We will also be adding additional representatives, up to about 15, for next year. This will help increase the utilization and reach into the accounts we can add next year. Additionally, we are going to be launching Preserve at the end of the first quarter, as well as the small sizes early next year. So I think you can expect a combination of growth in our existing accounts, increased utilization, and new accounts being added to our portfolio. Okay. Thank you, everybody, for joining. I look forward to the next call, and I appreciate your attendance.

This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation and have a great day.