TMCI - NASDAQ

Good day, and thank you for standing by. Welcome to the Treace Medical Concepts Second Quarter 2025 Earnings Conference Call. [Operator Instructions] Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker today, Trip Taylor, Investor Relations. Please go ahead.

Good afternoon, everyone, and welcome to our second quarter 2025 earnings conference call. Participating from the company today will be John Treace, Chief Executive Officer; and Mark Hair, Chief Financial Officer. During the call, John will offer commentary on our commercial activities, followed by Mark for a review of our second quarter financial results released after market close today. We will then host a question-and-answer session following our prepared remarks. Our press release can be found on the Investor Relations section of our website at investors.treace.com. This call is being recorded and will be archived in the Investors section of our website. Before we begin, we would like to remind you that it is our intent that all forward-looking statements made during today's call will be protected under the Private Securities Litigation Reform Act of 1995. Any statements that relate to expectations or predictions of future events and market trends as well as our estimated results or performance are forward-looking statements. All forward-looking statements are based upon current estimates and various assumptions. These statements involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated or implied by these forward-looking statements. All forward-looking statements are based upon currently available information, and Treace Medical assumes no obligation to update these statements. Accordingly, you should not place undue reliance on these statements. Please refer to our SEC filings, including our Form 10-Q for the second quarter of 2025 filed after the market close today, August 7, and can be found in the Investor Relations section of our website at investors.treace.com for a detailed presentation of risks. With that, I will now turn the call over to John.

Thank you, Trip. Good afternoon, everyone, and thank you for joining us for our second quarter 2025 earnings conference call. The second quarter in this transformational year for Treace demonstrates our commitment to meeting the evolving needs of surgeons and patients as we continue to drive our expanded portfolio of best-in-class bunion solutions into the market. During the quarter, we delivered strong top line and bottom line financial results and made substantial progress on our strategic initiatives. We believe we've laid the groundwork commercially and operationally to position us for continued growth in the second half of the year and beyond. Revenue in the second quarter was $47.4 million, representing 7% growth over the second quarter of 2024. We are pleased with the results and the overall performance of our products during the quarter. In addition to top line strength, we delivered strength across the entirety of the P&L as we executed on our expense management initiatives, lowered our cash usage and improved our adjusted EBITDA substantially. As we've discussed in recent quarterly calls, we've been focused on our vision to become a comprehensive bunion solutions company, and we're excited to have achieved this important milestone on our journey with a portfolio and a strategy in place to drive our next phase of growth. In addition to our flagship Lapiplasty and Adductoplasty systems, our portfolio now includes 3 new best-in-class bunion correction systems, namely our Nanoplasty and Percuplasty 3D MIS osteotomy systems and our SpeedMTP Great Toe Fusion system. This suite of technologies comprehensively addresses all 4 categories of bunions, and we believe this will allow us to further drive procedure penetration and expand our leadership position in the marketplace. We're encouraged by the high level of surgeon enthusiasm and the patient outcomes we've seen during the limited releases of our 3 new systems throughout the first and second quarters. And now we're excited to deliver these new solutions to a broader base of surgeon customers. Our inventory timing and volumes support customer demand in Q3 as well as Q4, our seasonally strongest quarter. Now I'd like to take some time to discuss our strategy to maximize market impact and drive overall growth by leveraging these new products as we enter our full market release. As a reminder, we participate in a market with a $5 billion-plus U.S. TAM, supported by a base of an estimated 1.1 million annual symptomatic surgical candidates in the U.S. And we estimate our penetration into this annual patient base is approximately 2.8% today. So there's a large untapped opportunity ahead of us. At its core, our go-forward strategy is centered around increasing procedure volumes while continuing to expand our customer base. As we scale, higher utilization driven by increased adoption of Treace technologies across a broader range of bunion types is expected to increase our market penetration and share, supporting a sustainable growth model over the long term. The execution of our strategy is focused on 3 key elements. First, we entered 2025 with a foundation of over 3,100 active surgeon customers, representing nearly 1/3 of bunion surgeons in the U.S. And if you look at this large and growing base of customers, we believe that on average, we've penetrated about 30% of their total bunion volumes. And with our new 3 targeted systems, we are focused on more effectively penetrating the remaining 70% of their bunion-related cases. Keep in mind, these are customers who use Lapiplasty technology already and have established relationships with their Treace sales reps. So bringing these new bunion products to our existing customers and becoming their one-stop shop for all their bunion needs presents a large and immediate growth opportunity and is a high priority for the company. Second, we believe our new bunion technologies allow us to attract a new audience of surgeons, those who currently prefer metatarsal osteotomy procedures for the majority of their bunion cases versus our Lapiplasty Fusion solution. Given that we have not offered any osteotomy solutions in the past, there have been limited opportunities to engage with these surgeons. With our expanded portfolio now offering 2 differentiated 3D MIS osteotomy solutions as well as our new Great Toe Fusion system, SpeedMTP, we now have multiple opportunities to appeal to this surgeon audience. Third, not only do we expect to add new surgeons through these new products, but we also expect that many of these new surgeons will adopt our flagship Lapiplasty and Adductoplasty solutions. And I'm pleased to report our strategy is working. During the limited market release of these new systems over the past 6 months, we experienced successful traction on each of these 3 fronts. Due to the market enthusiasm around our expanded best-in-class portfolio, we've experienced very high attendance at our 2025 Bunion Master surgeon training events. And following these events, we've seen a growing portion of existing Treace surgeons utilizing our new bunion technologies, surgeons that are new to Treace attracted by our new technologies, adopting these new systems into their practices and many of these new surgeons also embracing our core Lapiplasty and Adductoplasty technologies. The early traction we've seen bolsters our confidence in our strategy, which we believe will translate to accelerating growth in Q3 and through Q4, our seasonally strongest quarter of the year. In addition, these new systems are also being supported by expanded availability of several other complementary technologies, namely our IntelliGuide PSI pre-op planning and patient-specific cut guides for complex bunion and mid-foot deformity corrections, and our new SpeedPlate MicroQuad and SpeedAkin implants. We will also launch several new problem-solving sterile instruments in the back half of the year and cap off 2025 with a limited market release of our next-generation Lapiplasty system known as Lapiplasty Lightning. And with our rapidly expanding portfolio, we've become a top destination for some of the best foot and ankle sales reps in the industry. Access to cutting-edge technology and strong and supportive company culture, combined with the efficiency and scalability of our product model has proven to be extremely attractive to highly experienced foot and ankle sales professionals, and we are taking full advantage. Turning to our outlook. We are reiterating our revenue guidance for 2025. We continue to expect full year revenue to be between $224 million and $230 million, representing growth of 7% to 10% over the prior year. Before I close, we're excited to have reached yet another important milestone with the recent peer-reviewed publication of our ALIGN3D Lapiplasty clinical study, demonstrating successful patient outcomes out to 4 years. This long-term multicenter prospective study sets a high standard for clinical evidence and further differentiates Lapiplasty in the marketplace with our surgeons and patients. We look forward to expanding our market-leading body of clinical evidence as we continue our focus on advancing the standard of care for bunion surgery. In closing, this is a transformational year for Treace Medical as we establish ourselves as the premier one-stop shop for surgeons by bringing to market a comprehensive suite of differentiated best-in-class bunion systems. We've already made substantial progress on our strategic initiatives in 2025, which we believe positions us well for accelerating top line growth in the back half of the year. And with a robust pipeline of future technologies and a strengthening commercial organization, we believe we have the right strategies in place to drive continued growth in 2026 and beyond. With that, now let me turn the call over to Mark to review our financial performance. Mark?

Thank you, John. Good afternoon, everyone. Revenue in the second quarter was $47.4 million, an increase of $2.9 million or 7% over the prior year period. Growth was mainly driven by an increase in bunion procedure kits sold compared to the prior year. Gross margin was 79.7% in the second quarter of 2025 compared to 80.2% in the second quarter of 2024. Total operating expenses were $54.7 million in the second quarter of 2025, a 4% reduction compared to total operating expenses of $57.1 million in the second quarter of 2024. These reductions reflect continued execution on our expense management initiatives. Second quarter net loss was $17.4 million or $0.28 per share, an improvement of 18% compared to the net loss of $21.2 million or $0.34 per share in the second quarter of 2024. Adjusted EBITDA loss for the second quarter was $3.6 million compared to $8.7 million in the second quarter of 2024, an improvement of 58%. This represents significant progress towards our improved profitability goals for 2025. Cash, cash equivalents and marketable securities were $69.3 million as of June 30, 2025, compared to $76.1 million as of March 31, 2025. Total liquidity, including access to an additional $21.4 million of cash through our existing revolver, the balance of cash, cash equivalents and marketable securities would be approximately $90.7 million as of June 30, 2025. Compared to the prior year, cash usage decreased in the second quarter of 2025 and year-to-date by 55% and 78%, respectively, supporting our expected 50% reduction in cash used in the full year 2025 compared to 2024. We believe our balance sheet strength and flexibility is sufficient to continue executing our strategic and growth initiatives for the foreseeable future. Before concluding, let me turn to our outlook for full year 2025. As John mentioned, we are reaffirming our full year 2025 revenue guidance of $224 million to $230 million, which reflects an expected increase of 7% to 10% over 2024 revenue, with growth rates to step up sequentially in the remaining 2 quarters of the year. We continue to expect breakeven adjusted EBITDA for full year 2025 and expect our cash usage to decrease by approximately 50% for the full year 2025 versus 2024. Lastly, as you may have seen in our press release earlier today, we are excited to announce that we will host an Investor Day on Wednesday, September 3, in New York from 9:00 to 11:00 a.m. The event will include presentations by members of management and leading bunion surgeons highlighting our expanded technology portfolio. With that, let me now turn the call over to the operator to open the line for your questions.

[Operator Instructions] our first question comes from the line of Ben Haynor with Lake Street Capital Markets.

This is Aaron, on the line for Ben. I appreciate all the color on the call surrounding the new 3 new systems. I was just curious if you could maybe provide any more quantitative commentary or color on some of the surgeon profiles for those systems? And I guess the second part of that, do you expect volume ramps for folks adopting them to sort of track similarly to Lapiplasty? Any additional info there would be great.

Aaron, it's John. Great question. We do expect to see increasing volumes and revenue contribution from our 3 new systems as we progress throughout the remainder of 2025. Again, we're primarily tapping incremental new cases that we just weren't getting before and serving the osteotomy portion of the bunion surgeons practice. So our strategy at this point of our evolution is really focused on penetrating faster into the 1.1 million patient base and doubling our share of procedures with our customers. We know we're only getting about 30% of our current surgeon user bases bunion volume, and penetrating the additional 70% is key while also bringing on new customers that are attracted by these new technologies we have. All is good. Our TAM hasn't changed. We maintain our $5 billion TAM. These other products have some different ASPs, but nevertheless, still strong price points, and these are all incremental cases to what we were getting before. So we couldn't be more excited about where we are and where we're heading.

Great. No, really helpful. And then with the Lapiplasty Lightning system scheduled for the market release, can you just give us a sense maybe of what surgeon feedback has been so far? I think you mentioned a little bit on the call. And maybe whether or not you expect Lightning to support a reacceleration in 2026 in that Lapiplasty penetration?

Sure, sure. We've been working with our design team and on the Lapiplasty Lightning project for some time. We anticipate initiating an LMAR, a limited market access release, sometime in the fourth quarter. It's a significant advance forward for Lapiplasty. This is more than an incremental adjustment. This is a step function, I would say, in innovation, reducing steps, increasing reproducibility, delivering a faster procedure for the surgeon. Beyond that, we're not really revealing much more about it. We'll share more as we get a little further into the year, but we do see it as a growth engine and a growth driver for 2026.

Our next question comes from the line of Lily Lozada with JPMorgan.

I was hoping you could speak a bit about what you're seeing in the foot and ankle market. I know you talked about some procedures getting pushed out to later in the year and some of your peers have spoken about softer trends as well. But can you speak to what you've been seeing and how that's trended into July and August?

Lily, this is Mark. Maybe I'll take the first stab at this question. It's definitely early in the quarter. We saw Q2 playing out just the way we anticipated and we discussed last quarter, and we continue to anticipate growth to be more back half weighted this year. We talked last time about we don't believe any of these cases are lost necessarily, but they tend to compress more in the fourth quarter when there are some changes in patient scheduling. It's early in the third quarter. But with that said, nothing has changed since our last call. Our confidence in the back half and the full year really hasn't changed. We believe we understand the gating for this year and also the impact that our new products can have in the third and the fourth quarter now that we have them in much larger supplies. So our guidance has reflected what we understand, which will happen in the third and fourth quarter. We anticipate roughly 10% growth in the third quarter and a nice step-up from there in the fourth quarter.

Great. That's helpful. And maybe just following up on that. Can you speak a little bit about your visibility into the ramp in fourth quarter? I know a big step-up in revenues is not abnormal for Treace. But just in light of some of the market challenges in terms of procedures getting pushed out and expectations for the ramp of new products, how would you describe your level of confidence in that step-up? And what's assumed in the guide in terms of new products contributing and catch-up from delayed procedures?

Great question, Lilly. I appreciate that. And I would just kind of say some of the same things here that we talked on our last call that there was some changes in some patient scheduling. But again, our view isn't that these are lost cases. They tend to compress in the fourth quarter. We anticipate that to be the same thing this year that they're not necessarily lost. It's just really a timing thing. What's unique this year for Treace is that for the first time in the history of the company, we have this full suite of bunion products. We're hitting all 4 categories of bunions. And now for the first time here in Q3, we have full market launches, releases of these products and full inventory levels. And so to the extent there is this compression in the fourth quarter, we're in a position to really pick up even more of this revenue because we have more opportunities. We have more procedures available for surgeons, and we will have more surgeons doing cases in the back half of this year. So albeit some shift in the gating of the revenue, it really plays. I guess you could even call it to our advantage that we're going to have a lot more products available. So I think our guide continues to contemplate everything that we know at this point. And we're looking forward to stepping up the revenue growth. Each quarter of this year, there's a little bit of step-up. And so we anticipate fourth quarter to continue to step up and be our strongest quarter of the year.

Our next question comes from the line of Danielle Antalffy with UBS.

Congrats on a good quarter here. I just wanted to ask about how to think about the back half of the year and really the setup as we go into 2026. Appreciating you guys aren't going to give guidance there, but back half ramp looks pretty strong. And if anything, new products are ramping, right, as we go into 2026. So can you talk a little bit about your confidence in being able to get back to a sustainable double-digit growth trajectory in 2026?

Yes. So let me start and then John can probably add some additional color. As we think about the back half of this year, there's really a few opportunities that we have going for us. One is that we've got these new systems, all 4 bunion categories covered for the first time for the company. We also have really highly experienced new additions to our commercial leadership and sales team that we believe will also benefit us in the back half of this year. And then, of course, we have what we refer to as bunion season, which is this step- up in elective procedures that we begin to see at the end of Q3 and then into Q4. So all those things, we believe, are playing to our advantage. With respect to the guide that we've given for the full year, we are looking at double-digit growth in the back half of this year. And so we're not really speaking specifically to the growth rates into 2026. We need to learn a little bit more as we get these new products into more hands of our surgeons, but we feel like we've got a really good setup for the back half of this year. And again, the guide, the way we're looking at it, for the full year, we would expect around 10% growth in Q3. So that is double digits already this year. So every quarter in this year, we see this nice step-up sequentially in growth rates and Q4 is even a step-up from Q3. So we feel good about this year. Give us a little bit more time with these new products, and then we'll give a little bit more color on how we see 2026. But with that said, we really feel good about the setup for next year.

Great. And then my next question is, I appreciate that you guys are going to be having an Analyst Day in a month now. And my birthday is the day before, so I expect a cake, by the way. But just maybe a procedure...

Except we are taking them. We can give you cakes. We're not sure about bunion procedures.

I don't want to front run anything, but you guys have -- and I appreciate you're trying to work on margin expansion, things like that, but you're also filling out the portfolio. I assume you've got a lot going on organically. But any interest inorganically here to fill out the portfolio via small tuck-in type acquisitions?

Sure, Danielle. John here. Yes, we're always opportunistically leaning in, looking for new ways to drive growth, and some of that down the road could be through inorganic. And we do have a team keeping an eye on those types of opportunities. And if and where we find the right fit, we will be prepared to lean in. We also have opportunities outside the U.S. for this product line, and we're looking harder towards those opportunities as well. So to answer your question, yes, we're looking at a lot of different things.

[Operator Instructions] our next question comes from the line of Rich Newitter with Truist Securities.

It's Felipe, on for Rich. I guess just back to the elective procedures question. I'm just wondering if you're seeing any changes in appetite for foot and ankle elective procedures? And just like remind us of the typical seasonality with the business. Have you seen any changes since your last prior guidance? I know this is fourth quarter weighted guidance. So just maybe just dig into that a little more would be helpful.

Thanks for the question. This is Mark. Let me take a stab at that. So in our business and where we play in the bunion procedure, we've typically seen the strongest quarter -- seasonally strongest quarters in the fourth quarter, and that's when deductibles are met, when patients tend to have a little bit more time off to recover from their procedures, from these surgeries, and so we don't see any change to that this year. We did talk about last call that there was a little bit of shifting in some of the patient scheduling. And Q2 played out just the way we anticipated and just the way we discussed it. And so to the extent there is some of that shift, we believe that these cases aren't lost. They tend to push later in the year, so in the fourth quarter. Now historically, we've seen a really substantial step-up from Q3 to Q4. We're anticipating again a large step-up from a volume perspective and a revenue perspective, but this is very much in line with what we've seen year after year. That's just the way the market performs and what we anticipate seeing again this year. So I wouldn't say there's anything new since our last call, and I wouldn't say that there's anything new with respect to seasonality and what we're expecting in the fourth quarter. But the benefits that we have this fourth quarter is that we've got a lot more opportunities to penetrate into that very large bunion U.S. market with a lot more procedures. And so we're hearing and feeling enthusiasm from surgeon customers, who are trying these new products and seeing opportunities in their practices. And so that can work to our advantage in the third and fourth quarters when we have a lot more shots on goal, if you will, with many more new procedures available.