Establishment Labs - Q4 2025

Transcript

Raj Denhoy (CFO)

Thank you, operator, and thank you everyone for joining us. With me today is Peter Caldini, 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, February 24th, 2026.

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

Peter Caldini (Board of Directors)

Good morning. Thank you all for joining us today. Q4 2025 was another standout quarter for Establishment Labs. Fourth quarter revenue was $64.6 million, an increase of 45.2% versus Q4 2024, including Motiva revenue in the US of $17.3 million. This brings our 2025 total revenue of $211.1 million, an increase of 27.2% over 2024. US Motiva revenue in 2025 was $45.6 million, a number that I'm sure significantly exceeded everyone's expectations. As our business scaled, the operational leverage that we've been talking about is coming into focus. Q4 had a succeeding 70% gross margin for the second consecutive quarter, and our margins will continue to improve.

Our fourth quarter net loss from operations was $3.9 million, down 79% from Q4 2024. Our Q4 adjusted EBITDA was +$5.5 million, up from the -$13.1 million we reported in Q4 2024. This trend should continue throughout 2026, culminating in our first positive cash flow quarter this year. In 2027, we expect to be cash flow positive for the entire year, and our margins should improve for years after that. With this trajectory and our ending cash balance is $75.6 million in 2025, we have no need for additional capital. As noted at the J.P. Morgan Healthcare Conference, we are comfortable not only setting guidance for 2026, but also providing some visibility into 2027.

As such, we are giving guidance for 2026 of $264 million-$266 million, and there may be some upsides to these numbers. At a minimum, this is a 25% growth, and we believe that 2027, we will see at least this level of growth as well. Q4 capped off a remarkable 2025 for Establishment Labs. We didn't just see the US market for growth in the years to come. We established ourselves as the company transforming the industry, materially changing and increasing the conversation about breast aesthetics. The $45.6 million in US revenue, an approximate 20% augmentation market share exiting 2025, is something that took the last new entrant almost 10 years to achieve, and we did it in one. How do we accomplish this?

First off, there's been a complete lack of innovation in breast aesthetics for decades. We have had an active R&D pipeline since 2010, which continues today and is unparalleled in the industry. Our R&D investment continues to translate into highly differentiated products that address significant unmet needs in the market. When patients review or hear about the FDA study complication rates for today's commercially available implants, they recognize that Motiva should be part of the decision when selecting both a surgeon and an implant. Plastic surgeons tell us that when patients are presented with different implant options during consultation, 9 out of 10 choose Motiva, even at a higher price point. This isn't just about data for them. Patients are gravitating towards Motiva when they compare implants in their hands.

When doctors dig into the science and data behind Motiva, they find rigorous scientific literature that details our technologies and why our implants are designed to create better patient outcomes. The process of consideration has been amplified and is actively discussed across social media. There is a new era of transparency that has evolved as women share their journey and talk openly about their aesthetic goals and decisions. An estimated 300,000 women get a primary breast augmentation every year in the United States. It continues to be the number 1 aesthetic surgical procedure annually. It has always been a secret shared quietly. Social media has created a new paradigm where aesthetic and beauty secrets have become normalized.

We believe that the combination of our innovative products and this new era of transparency is creating meaningful market expansion. We can already see the start of this trend. It is not just patients that are excited about Motiva. For the first time in a very long time, plastic surgeons have a product and a surgery to talk about. It's new, it's differentiated. They are taking to social media to talk about it. Their excitement and passion for Motiva and what it means for breast augmentation comes through. Patients are responding. We are very thoughtful in how we spend our marketing dollars. Obviously, compared to some of our competitors, our resources are limited. The marketing value we are receiving from patients and doctors is a competitive advantage and is very difficult to compete with.

Our innovation and its reception in the market is driving adoption, and plastic surgeons report to us that many patients come in asking for Motiva by name, whereas prior to Motiva, they would rarely ask for a brand. All this has led to one of the fastest product launches in breast aesthetics history. The momentum has continued into Q1 of 2026, with both January and the first 2 weeks of February exceeding our expectations. Since launch in late 2024, we have onboarded over 1,500 accounts. We continue to sign up new practices every day. January and February are peak conference months for plastic surgeons, and Motiva continues to dominate the podium discussions, with surgeons actively seeking us out at these events to learn more and engage with us. It certainly appears our growth curve will continue.

In a recent blinded survey of plastic surgeons, 88% said they either use or are interested in trying Motiva, with the top reasons including patient-driven demand and unmatched safety profile, the benefits of SmoothSilk surface, and the opportunity for above-the-muscle placement. In the survey, 75% of surgeons noted they've been asked for an implant brand by name, and surgeons reported that 93% of the time, that brand was Motiva. Patients actively seeking out Motiva is having a significant impact on account volumes. In that same survey, surgeons with greater than 50% Motiva share in their practices saw year-over-year growth in augmentation volumes that was more than double that of surgeons primarily using another brand.

This is important because while many early adopters have moved the majority of their volume to Motiva and are seeing the benefits of this on their practice volumes, the opportunity to grow our share of procedures and accounts remains significant. This is not surprising given how clinic onboarding has ramped up over the year and because many surgeons plan and schedule surgeries months in advance. As we move through 2026, we expect to see our share in these accounts to move meaningfully higher. These efforts are being supported by a best-in-class commercial organization. In 2026, we plan to expand our U.S. sales force with the addition of up to 15 more sales representatives, a majority of whom have already been hired. This team of seasoned industry veterans are in plastic surgery accounts every day, pushing our share higher.

2025 was also the year we started to introduce the concept of minimally invasive breast augmentation through our early experience of Preserve. We had strong global demand, and we're confident that patients and doctors in the U.S. would be equally receptive. If Motiva implants alone were exciting in the U.S. market, what would that technology, plus the promise of smaller incisions, minimal anesthesia, and fast recovery, bring? The acceptance and demand outstripped even our own expectations. For decades, plastic surgeons contended these ideas were not important to patients. You just have to look at the social media response and know that patients feel very differently. We have two types of women choosing Preserve. The first are women that are already committed to the idea of breast augmentation but are now choosing Preserve at a much higher price point because of the benefits over traditional augmentation.

The second are women that were simply not interested in legacy breast augmentation procedure, but are now considering and booking surgery. For that second group, it may have been the aversion to general anesthesia, the fear of extended downtime that disrupts daily life, or a number of other factors. Regardless, they are now part of a whole new group of consumers considering the possibility for the first time. Of the organic leads that have come through the Preserve section of our website pre-launch, 81% of patients looking to get connected with the surgeon said they are only interested in getting a breast augmentation if they can get Preserve. This marks a meaningful paradigm shift in the industry, with Motiva uniquely positioned as the only solution meeting evolving consumer interest. We charge about 2 times more for Preserve than we do for traditional breast augmentation.

Preserve is not only expanding the market on a dollar basis, it's expanding procedure volumes as well. Based on our U.S. early experience, we are seeing expansion in the category. Approximately 15% of Preserved patients in the US reported they were not previously considering a breast augmentation prior to learning about the procedure. In March, we are moving from our early experience to a full launch. We have trained more than 90 surgeons, many of whom report patient wait lists and women traveling across the country to access the procedure. In a recent survey with consumers on Preserve. Over 55% of patients considering breast augmentations indicated a willingness to pay a premium, and surgeons are currently charging 30%-50% more than traditional augmentation. The average breast augmentation in America is about $9,000, and currently, the average pricing for Preserve is more than twice that.

This pricing reflects the value of a less invasive, tissue-preserving option with faster recovery and minimal anesthesia. We expect to have at least 200 plastic surgeons trained by the end of 2026. If you're doing diligence around the impact that Preserve is having, I suggest talking to surgeons that have performed a number of cases. At least 5 surgeons have already done more than 40 cases in geographies that span coast to coast. Surgeons cite the benefits of Preserve to patients, but also to their practices. One plastic surgeon told me recently that Preserve was game-changing. He used to have a local practice occasionally, regionally. Now he has patients flying in from all over America. Another plastic surgeon that methodically tracks her metrics reports that she's able to do 3 or 4 more operations per week with the time that Preserve saves her.

Our minimally invasive surgery portfolio is a real win-win for all. Patients are getting access to benefits that are incredibly important to them. Surgeons are able to charge more per patient and do more surgeries at the same time. Better experience for patients and better businesses for surgeons. In December 2025, we also submitted Motiva implants to the FDA for approval in primary and revision breast reconstruction. Reconstruction represents a significant strategic opportunity as it effectively doubles our total addressable market in the United States, while offering higher Average Selling Prices. Motiva Flora breast tissue expander is already in 200 facilities nationwide. This footprint should continue to expand as we move closer to FDA approval.

In addition, we remain active in communications with the FDA regarding our small sizes submission, which will further expand our portfolio, meet a broader range of patient needs, and allow us to take a higher percentage of cases by surgeons already using Motiva. Beyond these initiatives, Mia, Ergonomix2, and GEM are also part of the innovation pipeline that we're working to bring to the US market in the coming years. Along with our success in the US, our OUS performance remains strong and well-diversified. A major focus for us in 2025 was our direct markets, and we have seen very good results. The number of accounts in many of our direct markets continues to grow, underscoring the strength of demand. European direct markets delivered more than 20% growth for the third consecutive quarter, led by outstanding performances in the UK, Germany, and Spain.

In Latin America, results have stabilized in Brazil, while Argentina continues to post strong growth. Additionally, our recent acquisition of Benelux exceeded our expectation in the first year. While distributor markets can fluctuate based on the timing of orders, we are seeing healthy demand globally. Across APAC, China remains a key focus, and we're actively working with the local distributor and seeing improved performance. Our minimally invasive platform, Preserve and Mia, continues to demonstrate strong momentum outside the United States. Preserve is now available in 33 global markets, with demand exceeding expectations and more than 700 accounts opened. Mia outperformed the $8 million-$10 million guidance in 2025 and has more than doubled the number of accounts compared to 2024.

Notably, all Mia clinics have adopted Preserve, enabling them to offer the benefits of a less invasive augmentation solution to a wider range of patients at price points far greater than a traditional breast augmentation. Globally, we expect demand for our minimally invasive platform to exceed $30 million in 2026 and continue to be a key growth driver in years to come. As I'm sure you have noted, we issued a second press release this morning around the management transition we're making effective March ninth, which is really about getting Establishment Labs ready for our next phase of growth. Over the past several years, we have been focused on driving efficient execution and scalability. We are now adding additional leadership to sustain operational momentum while ensuring oversight of initiatives that require deep business expertise and strong leadership.

With this, we are delighted to have Raj transition into the role of SVP, Global Strategy. His deep understanding of our business, strategic perspective, and broad industry experience will be instrumental. There are a number of initiatives underway that should keep us at a very high growth rate for the foreseeable future. Exactly how we execute these requires extensive planning and oversight. Along with this, we are pleased to welcome Cassandra Harris as our new Chief Financial Officer. Her strong background in operational excellence and proven track record of strengthening financial discipline while enabling growth, will be critical as we execute on our priorities ahead. I will now turn the call over to Raj.

Raj Denhoy (CFO)

Thank you, Peter. Total revenue for the fourth quarter was $64.6 million, an increase of 45.2% from last year. Excluding the positive impact of foreign exchange in the quarter, growth would have been approximately 39.4%. Sales for Motiva in the United States were $17.3 million. On a geographic basis in the fourth quarter, sales in Europe, Middle East, and Africa were 41% of the global total. We saw strong growth in the region overall, including another good quarter in our direct markets, where we exceeded 20%, as well as good demand from our distribution partners. Sales in the United States were 26.8% of the global total. Latin America was 18% of sales.

Brazil remained stable, and we saw good growth in Argentina, our other direct market in the region, as well as from our distributors. Asia Pacific was 14.1% of sales. Results in the quarter reflected the comp in the year ago period, where we saw sales to our Chinese distributor, as well as the normal ebbs and flows of distributor purchase timing. Gross profit for the fourth quarter was $45.5 million or 70.5% of revenue. This was a 200 basis point increase compared to the 68.5% of revenue last year. Overall, in 2025, our gross profit margin increased 330 basis points compared to 2024, primarily the result of the higher margin sales in the United States. SG&A expenses were $44.0 million and were flat compared to the fourth quarter of 2024.

R&D expenses for the third quarter were $5.4 million. Total operating expenses for the fourth quarter were in line with the year-ago period at $49.5 million. Adjusted EBITDA was positive $5.5 million in the fourth quarter. This compared to a loss of $13.1 million in the fourth quarter of last year. This is our second consecutive quarter of positive adjusted EBITDA. The $18.6 million improvement year-over-year in adjusted EBITDA was driven by the strong sales and the higher gross profit in the US. We've also been very focused on managing our operating expenses overall. Over the course of 2025, we grew our U.S. commercial operations, and we launched the second offering in our minimally invasive portfolio.

We were able to do this and still generate increasing profitability by finding efficiencies across all parts of the organization and making structural changes when needed. Cash increased $4.9 million in the fourth quarter to $75.6 million. The increase was primarily the result of reduced operating cash use, as well as inflows from option exercises. For 2026, our initial revenue guidance is for $264 million-$266 million, an increase of 25.1%-26% over 2025. We expect our OUS business will grow in the single digits, and the US will exceed 30% of overall sales, which is up from approximately 22% in 2025. Gross margins are expected to increase 200-300 basis points.

Operating expenses in total are expected to be approximately $195 million-$200 million in 2026. As we saw in 2025, there can be some variability in quarterly spending levels based on the timing of expenses. We expect to be adjusted EBITDA positive every quarter in 2026. Cash use will continue to improve over the course of 2026. Our free cash use is expected to be less than half of what it was in 2025. We expect to reach cash flow positive this year without the need for any further equity raises. Our credit facility will enter the last year of its term in April. We are considering a number of refinancing options. Overall, our financial outlook reflects a significant momentum in our business.

The adoption of Motiva in the U.S. is still early, with significant room to drive further practice adoption as well as penetration within accounts. Preserve will add to both procedure growth as well as our realized ASPs. Outside the US, global demand remains good, and our focus on direct markets and our minimally invasive portfolio should lead to another solid year of results. Down the P&L, gross margins are benefiting from the positive geographic and product mix playing out. Even with continued investments, incremental operating spending over the next few years will be at a rate well below top-line growth. This leverage should allow us to achieve cash flow profitability in the second half of the year and is the basis of the meaningful and increasing earnings we expect to see in 2027 and beyond.

We continue our work to make ESTA eligible for inclusion in a number of indices, including the Russell. Recent updates have increased our confidence that we will be included this year. Finally, as Peter mentioned, I'm moving into a new role at Establishment Labs. With the company on a good financial footing, Peter and I have been discussing the best way for us to realize the significant potential we have to create shareholder value. ESTA is in a very unique situation, with unmatched innovation and products and a pipeline that even further distances us from our competitors. To realize this, effective execution is the key. The company has grown very organically over the past 20 years, and there are a number of areas that have the opportunity to be strengthened. After 5 years as CFO, I'm looking forward to a new challenge of leading our global strategy.

In this new role, I will remain actively engaged in driving our performance, but the day-to-day finance function and CFO role will transition to Cassandra Harris, who was selected after an extensive search. With that, I will turn the call back to Peter.

Peter Caldini (Board of Directors)

Thank you, Raj. While continuing to invest selectively, we are maintaining an investment pace well below the expected top-line growth. We expect to achieve free cash flow positive in 2026, with meaningful earnings beginning in 2027. I'd like to thank the entire organization for a great 2025. This year, we remained focused on disciplined execution and building a global category leader. Operator, we're ready to take your questions.

Operator (participant)

Thank you. We will now conduct a question and answer session. If you would like to ask a question, please press star one on your telephone keypad. As a reminder, this conference is being recorded. A confirmation tone will indicate your line is in the question queue.

You may press star two to remove yourself from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. Once again, that's star one to ask a question at this time. One moment while we poll for the first question. The first question comes from Joshua Jennings with TD Cowen. Please proceed.

Joshua Jennings (Managing Director and Senior Analyst)

Hi, good morning. Thanks for taking the questions. Congratulations with strong end of the year and excited for you, Raj, in your new role. I was hoping to just start on the minimally invasive portfolio. I mean, it seems clear that Preserve and Mia are pulling patients off of the sidelines. A couple of years back, I think prior to your tenure, Peter, the team had kind of put forward the potential for the minimally invasive portfolio to grow the market and grow breast augmentation procedure volumes, maybe even double them. Can you just, maybe not going to put that stake back in the ground, but can you just talk about the optimism and the trajectory of the market with minimally invasive offerings from Establishment coming through?

Peter Caldini (Board of Directors)

Yeah, thank you. Thank you, Josh. I mean, what we are seeing in the OUS markets with the minimally invasive platform from the early experience in the US is extremely positive. I think, you know, with the benefits of no general anesthesia, smaller scars, faster recovery, you know, I think that really resonates with patients, and we're seeing that in the marketplace. Also with some of the surveys, when we talk about 14% of patients that decide to do breast augmentation, were not considering until they heard about Preserve, and that's in our early experience survey in the US.

It's a real driver for what we think is not only to drive share for us in the market, but also to bring new patients and new women to the category. We're really seeing that benefit. You know, we think that that's going to continue to be a key driver. It's going to be a bigger part of our business as we go throughout this year as well as next. In our estimate, what we put in terms of the guidance, over $30 million this year, and we feel very confident with that. This will be a real driver for us this year as well as into the future.

Joshua Jennings (Managing Director and Senior Analyst)

Excellent. Maybe just one follow-up. Appreciate you laying out U.S. revenues being roughly 30%. You are planning on adding reps around 30% higher number. Maybe just talk about where you're pulling these reps from. Are you still taking all-star veterans from the competition in the breast implant sector or the aesthetic sector? Just remind us of how the productivity can ramp for these new reps as they come on board over the course of 2026. Thanks for taking the question.

Peter Caldini (Board of Directors)

Yeah, thanks, Josh. I mean, I think one of the key drivers for our success in the U.S. market is, you know, we've been able to put together a best-in-class organization, you know. If you couple that with what we believe is the best products from a performance and a safety profile, and bringing together with the, you know, the best-in-class organization. We're very focused on the type of reps that we bring to Establishment Labs, and we are continuing to focus on reps that have significant industry experience, that have a very good reputation in the market, that have a very strong track record.

You know, I think what's very positive for us is that a lot of these reps see us as very attractive opportunities, and that will continue to be a key driver for us in this year as well as into the future.

Operator (participant)

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

Mike Matson (Senior Analyst)

Yeah, thanks for taking my question. just want to start with one on reconstruction in the U.S. you know, can you maybe just talk about how you plan to launch into that market, and when you do get the FDA approval, do you need specialist reps? Do you need maybe, like, a corporate accounts type of sales team? you know, maybe just talk about the importance of hospital contracts there.

Peter Caldini (Board of Directors)

Yeah. Thank you. Thanks, Mike. I mean, as you see, you know, we've highlighted the recon indication is a really large opportunity for us. I mean, it really doubles the market potential for us. We've already kind of seeded the market with some of the with Flora, we're in over 200 accounts. As we get closer to the launch, we will be obviously expanding our sales force. We'll probably look at a combination of some reps that will be hybrid, we'll have some dedicated reps specifically for the larger hospital network. You know, I think that we need to make sure that we have the right coverage, right sales support to ensure that we really capitalize on that opportunity.

You know, as I mentioned before, we've already gotten some seeding in terms with the Flora, so I think the ramp up will be a little bit quicker. You know, I think, but as it relates to the sales force, we want to make sure we have some specific coverage, but we're also going to be leveraging the existing sales force.

Mike Matson (Senior Analyst)

Okay, got it. Then the international growth was a fair bit stronger this quarter. Was there any kind of one-offs in there, stocking orders or anything like that? Is this truly reflective of the underlying procedure growth that you're seeing?

Peter Caldini (Board of Directors)

Yeah, I mean, I think. Listen, this year, we made a very strategic focus on driving our direct markets. You know, we've really been successful in terms of driving growth in those markets. We've allocated resources from a supply as well as investment standpoint. We made some organizational changes, and you're seeing the benefits of that. You know, we've had 20% growth the last 3 quarters. Preserve is also helping to drive that as well as we increase the number of accounts. In general, I would say that the demand across all our markets is fairly stable and, you know, in terms of how we finish the quarter, you know, I don't think there was any, you know, necessarily any stocking orders.

It's just sometimes what you'll find in the distributor markets, there is, you know, some, you know, different periods. It's not always a straight line. It's a little bit choppy in terms of that. You know, there was no efforts in terms of, you know, any type of additional inventory or stocking. It's just really based on the demand that we're getting in the marketplace. It's also based on the good execution.

Mike Matson (Senior Analyst)

Okay, great.

Peter Caldini (Board of Directors)

I don't know, Raj, if you want to add anything in terms of the phasing.

Raj Denhoy (CFO)

No, I think that's fair. I mean, it's, as Peter noted, I mean, there's always some ebbs and flows in the distributor markets, in particular, based upon the timing of orders, but overall demand remains very healthy across all the regions. The direct markets, which we control ourselves, obviously, are doing very well right now. We're executing at a high level.

Mike Matson (Senior Analyst)

Okay, great. Thanks, guys.

Operator (participant)

The next question comes from Anthony Petrone with Mizuho. Please proceed.

Anthony Petrone (Managing Director Equity Research)

Thanks, and congrats on a strong year. Congrats, Raj, on the transition, Cassandra, welcome to the team, if you're on the call. Maybe just, maybe around the horn globally, I know the macro's come up quite a bit. It seems a little bit better, maybe on a, you know, 3-month to 6-month basis here when you think of the regions. Maybe just a quick recap, you know, where do you see the underlying augmentation markets, US, in some of the core OUS markets, thinking of Europe, China, Korea, I'll have a follow-up question.

Raj Denhoy (CFO)

Yeah, Anthony, you know, the question's really on the underlying markets. I mean, generally, the markets feel healthy right now. You know, the US, you know, for us, we're growing at a high rate, so it's, you know, we're kind of well exceeding what's happening in the underlying market. As we've noted, you know, there does seem to be some increased interest in breast augmentation procedures, and I think a lot of that's been driven by the activities we're doing, certainly. It does feel like the market in the US is very healthy, and we hear that from surgeons as well, with surgery schedules booked out and, you know, lots of interest. Overall, I'd say the US remains quite healthy. Internationally, frankly, we're seeing the same thing. You know, in our distributor markets, you've seen north of 20% growth now for several quarters.

You know, that's, that, again, is pretty indicative of what's happening on the ground and also with our share taking. Then in distributor markets, likewise, you know, the demand seems to be quite good. You know, China, you mentioned, has been a market that we've highlighted as had some challenges. You know, it's taking a lot of focus of management in the company. We're spending a lot of time with that distributor, and frankly, we're seeing the results, you know, starting to turn a little bit. So overall, I'd say, you know, the markets remain healthy for us, and you can see it in the numbers.

Anthony Petrone (Managing Director Equity Research)

That's helpful. A follow-up would be on just the Establishment Labs mix. You know, when you think of Preserve year coming in, and obviously good feedback, but also reconstruction. What do you think, I guess, Preserve can be as a % of total revenues, you know, once we get into the sort of 2027-2028, you know, time range? You know, can it eventually be 50% of, let's say, US revenues? If that's the case, you know, what do you think the tailwind looks like to your gross margin? Thanks.

Raj Denhoy (CFO)

Yeah. I mean, Anthony, it is early still, right? Preserve launched, you know, essentially a year ago in Brazil. It was February of 2025, right? The demand we've seen has been very strong. You know, the U.S., globally, there's a lot of interest. It has really, I think, caught the attention of surgeons. You know, it fits into the way that they do surgery. You know, a number of them are saying, "Why would I do surgery any other way, frankly?" Your numbers are getting to 50%, you know, are not outside the realm of possibilities. I mean, I think we could see that kind of penetration.

To your point about what it does to our gross margins, you know, the ASPs we realize for a Preserve case, relative to a case that only uses the implant, it's about 2x the revenue for us as a company, and they are much higher margins, so it is a tailwind to what you're going to see on the gross margin side. That, combined with the ASPs in the U.S., what's going to happen with recon, it just adds to a number of initiatives that are going to support the gross margins going significantly higher over time.

Anthony Petrone (Managing Director Equity Research)

Thanks.

Operator (participant)

The next question comes from Sam Eiber with BTIG. Please proceed.

Sam Eiber (VP and Medical Technology Analyst)

Hi, good morning. Thanks for taking the questions here. Maybe I can come back to the U.S. for just a second, and Peter, get your thoughts on some of the momentum you called out in the early days of 2026. Then, I guess, where you think you are along this growth trajectory, you know, is the long-term outlook for share gain still around the same goalpost that you've laid out in the past?

Peter Caldini (Board of Directors)

Thanks, Sam. You know, we continue to have very strong momentum going into 2026. You know, we, as I mentioned in the prepared remarks, there's a lot of opportunity to continue to gain share in the accounts that we're already in as we increase the utilization rate, as the surgeons work through their scheduling.

We're also going to be continuing to add accounts, so, like, put more accounts on the top of the funnel. That's going to be significant drivers for us. As we mentioned, also, we're going to be adding up to 15 reps, and a bulk of them have already been brought on. We started that process. I think we mentioned in the last earnings call that we were going to start that process the end of last year. We've had close to 10 reps join the organization so far, and we're going to continue to bring those reps. That's going to be a key driver for us. You overlay the fact that we're going to be launching Preservé, and the strong performance that we've seen outside the U.S.

Also in terms of the early experience, it's creating a lot of excitement in the U.S. market, so that will continue to be a key driver for us. In 2026, we're expecting to get the smaller sizes approved in the first half of this year, depending on the FDA, but we're very confident we should have that in the first half of the year. That's just going to really be the start of the super cycle of innovation that we mentioned before with the recon indication, which we are expecting to be a key driver for us in 2027. Also looking at Ergonomix2, which will enable us to bring Mia to the marketplace. You know, our plan is still the same.

We expect to be a dominant share in the U.S. market. We're on that path to get there, and, you know, I think that's probably going to happen a little bit sooner than, you know, I think I originally planned, just based on the strong momentum we've had so far.

Raj Denhoy (CFO)

Yeah, Sam, I, you know, if you, if you look at the guidance we've given, you know, for the U.S. for it to exceed 30% of our sales, you know, it's almost a third of our sales will be coming from the US, if not more, in the second full year. We've got a lot of momentum, and the U.S. is doing very well.

Sam Eiber (VP and Medical Technology Analyst)

Yeah, really helpful there. Then maybe just following up on the last point, obviously, you guys have a lot of, you know, organic opportunities with minimally invasive recon, but, you know, maybe longer term, are there any gaps in the portfolio where maybe you're looking at that, you know, you have this, the infrastructure now, where maybe you could be adding additional capabilities, to the portfolio?

Raj Denhoy (CFO)

Sam, it's a good question, you know, and I think it's part of the reason for my transition, you know, into this global strategy role, is that, you know, with the financial performance of the company in a very good spot, you know, there are things like you're describing, you know, business development, go-to-market strategies, you know, the way that we, you know, we prioritize things in our portfolio of innovation that I can now spend more time focusing on, right? There are significant opportunities, as you're describing, to continue to expand what we're doing and to really realize the potential of what this company has put into motion.

Sam Eiber (VP and Medical Technology Analyst)

Really helpful, and congrats on the transition here.

Operator (participant)

The next question comes from Allen Gong with JP Morgan. Please proceed.

Allen Gong (VP and Equity Research)

Thanks for the question. You touched upon it already in response to some other questions, but I'm just curious about the contribution you're currently factoring into the 2026 guide from some of the, you know, pipeline products you have between small sizes and reconstruction. Is reconstruction going to be more of a 2027 story? How quickly can you really ramp that up once you get the approval, since, as you've mentioned, you're already seated in around 200 hospital facilities?

Raj Denhoy (CFO)

Yeah, on reconstruction, it is likely a 2027 and 2028 and beyond story for us, right? Obviously, it's still with the FDA. Nothing has changed our opinion that product is approvable and should be very soon. There is the blocking and tackling of simply getting into hospitals, right? It takes time to work through the VAC committees and to get on contracts and things, and that will take time. What we've already done is we've seen strong interest from hospitals already. We're already in a number of them, and there's a lot of interest in recon getting to market and getting in the hands of a lot more surgeons.

Peter Caldini (Board of Directors)

Yeah, Allen, just to add to that, you know, as Raj highlighted, and is, you know, the recon, our expectation is that's where we're going to see the impact in 2027, so we're not really considering that for 2026. Also, as you look at Preserve, I think we see a tremendous upside in those numbers. You know, I think we've been very pleased with the initial response, not only in the US, but outside the US, and I think that has the opportunity for upside for us in terms of how we drive the business this year.

Allen Gong (VP and Equity Research)

Got it. Just a quick follow-up on spend. You know, when we look at 2024, we saw a pretty linear increase in spend to support the U.S. launch. This year was a little bit bumpier, talking specifically about SG&A, and it sounds like you've already put in a good amount of investment into the U.S. salesforce expansion you previously talked about early on in the year. Just any color on the cadence of, you know, spending on the operating side throughout the year. Should we expect it to be a little bit more front half weighted, and then a little maybe improvement in the back half, and then maybe next year, we see a little bit of a step up to support reconstruction? Thank you so much.

Raj Denhoy (CFO)

Yeah, I think your question is a good one. I mean, you look at the overall spending for us, you know, we've talked about $195 million-$200 million, but if one X is out, non-cash expenses and one-time things, you know, that's $175 million-$180 million in cash operating expenses, which compares to a number, you know, roughly $160 or so, right? The increase is well below, you know, the $50+ million of revenue expansion we're going to see this year. We are starting to see the significant leverage in the model playing out, and that's going to continue in 2027 and beyond. Even the incremental investment to support the recon market will be well below the opportunity that that represents.

Again, that's another source of leverage for us. As it relates to kind of the timing, it is not linear, right. We do have certain expenses that hit at certain times, you know, as the first quarter will actually likely be a little below trend, and then it'll pick up in the back half of the year. You know, we're supporting a lot of the U.S. expansion early on, and then it'll continue to be leveraged over the course of the year. It's not gonna be kind of flat every quarter, as you described. It'll be a little up and down, with the first quarter perhaps being a little lower and then picking up in the middle part of the year in the back half.

Operator (participant)

The next question comes from Caitlin Roberts with Canaccord Genuity. Please proceed.

Caitlin Cronin (Director and Equity Analyst)

Hi, thanks for taking the questions, and congrats on all the new roles to all. As it relates to revenue guidance, anything to call out from a seasonality perspective this year, particularly as you ramp further in the U.S.?

Raj Denhoy (CFO)

It's a good question, right? Because the US, we do expect, is going to continue to grow, right? Sequentially, we should be up in the first quarter, modestly, right? It is a quarter where it's usually a down quarter for the market overall, and then you'll see kinda continued step-ups every quarter with a very strong finish to the year in the US, again, following normal seasonality. Internationally, it's a bit more normalized because you're not quite growing the same rate you are in the United States. Overall, you know, it's gonna be that similar pattern where the first quarter is down, you see a pickup in the second quarter, it's down a little bit in the third quarter, and you see a very strong finish to the year.

You do have the subtlety of what's happening in the U.S. with the very strong growth we're seeing, overall.

Caitlin Cronin (Director and Equity Analyst)

Great, thanks. Just one more. You know, just how many of your current accounts in the US would you say are high volume accounts? Any color on kind of the average penetration within, your accounts?

Raj Denhoy (CFO)

Yeah, it's a good question. I mean, when we started, you know, a little over 1 year ago, we did sign up a lot of high volume, larger accounts, a lot of interest in the product. That's broadened out a bit. You know, the 1,500 plus accounts we have now kind of span the spectrum of where we are. I would say, you know, while it's hard to get exact numbers on penetration, we're still quite low in a number of markets, and that's based primarily on the timing of when these accounts came on, right? Account that's been with us for 6 months or less, it's gonna be lower than one that's been with us for a year.

2026, the story for us is gonna be about continuing to expand the number of accounts that we have in the United States, but also going quite a bit deeper into all these accounts. That's what's really gonna drive the results. There's a lot of potential there. We're still early in a lot of the customers we've signed up over the back half of last year.

Peter Caldini (Board of Directors)

Yeah, Caitlin, just to add, you know, that's gonna be a big focus for us in 2026. Obviously, in the beginning, you wanna get as many accounts, and, you know, the, the early adopters, I think we've really seen, you know, strong push where, you know, Motiva is a majority, if not, you know, almost all their volume. It's really now then, the next phase is really enhance that penetration, and that's a big focus for us. I think there's a lot of, you know, opportunity in that area. I think in certain accounts, we're underdeveloped. Now, granted, that's gonna happen over time as they work through their schedules. As, as Raj noted, this is a key driver for our growth, you know, this year.

Caitlin Cronin (Director and Equity Analyst)

Awesome. Thanks so much.

Operator (participant)

The next question comes from Mason Carrico with Stephens. Please proceed.

Mason Carrico (Research Analyst)

Hey, guys. Thanks for the questions here. I guess first, could you just talk about your expectations around China this year? What are you baking in there? Sorry if I missed it. Really, what do you view as kind of the key hurdles to unlocking that market, whether it be in 2026 or 2027 or, you know, a future year?

Peter Caldini (Board of Directors)

Yeah, thanks. You know, as we mentioned, in the prepared remarks, we've really communicated this in the last couple of calls, you know, this is a big focus for us. You know, I think the start in China in terms of the distributor building out their commercial capability was slower than we would have liked, and we put a lot of focus in that area in terms of, you know, around their organization, in terms of some of the strategy and targeting different hospitals' pricing. You know, we've been very pleased over the last 6 months in the back half of the year that we're seeing very good progress in terms of the sell-out.

I think a lot of this work is really having an impact, and, you know, our expectations remain the same. You know, this market is a very large market, and when we expect to have the same type of, you know, dominant share in China that we do it throughout the rest of Asia.

Mason Carrico (Research Analyst)

Got it. Okay, with the launch of Preserve this year, it seems like ASPs in the U.S. should benefit. I guess, how much of US growth in 2026 do you really see coming from volume versus ASP expansion? I guess, how do you think about that algorithm, that growth algorithm, even moving into 2026?

Raj Denhoy (CFO)

Yeah, I think, Mason, we're still so early in the penetration in the United States that the majority of the growth is gonna come from continued unit growth, right? If that's how you described it, right? Continue to take share, procedure volume, you know, that is what's gonna drive the revenue. Preserve is certainly going to contribute. We're gonna launch it here, you know, in the first quarter, very soon, and, you know, it'll play out over the course of the year. For us, it's still primarily about penetration into this market and taking share, you know, from the incumbents.

Mason Carrico (Research Analyst)

Got it. Thanks, guys.

Operator (participant)

Thank you. That is all the time we have for questions today. I would now turn the call back over to Peter Caldini for closing remarks.

Peter Caldini (Board of Directors)

Thank you, operator, and thank you, everybody for joining the call today. You know, we've made a tremendous progress over the last 12 months. I think we're in very good position to really capitalize, I think, on a unique opportunity and the strengths that we have, especially as around our product and pipeline. Very happy with the progress and really appreciate everybody joining the call today, and I look forward to talking to everybody in the future. Thank you.

Operator (participant)

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