TMCI - NASDAQ

Good day, and thank you for standing by. Welcome to the Treace Medical Concepts, Inc. first quarter 2025 earnings conference call. At this time, all participants are in a listen-only mode. After the speakers' presentation, there will be a question and answer session. To ask a question during the session, you will need to press 11 on your telephone. You will then hear an automated message advising that your hand has been raised. To withdraw your question, please just press 11 again. Please be advised that today's conference call is being recorded. I would now like to hand the conference over to your first speaker today, Tripp Taylor, Investor Relations. Please go ahead. Thank you.

Thank you, operator. Good afternoon, everyone and welcome to our first 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 first 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 in the Investor Relations section of our website at investors.treace.com. This call is being recorded and will be archived in the investor 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 our 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 Concepts, Inc. 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 first quarter of 2025 filed after market close today, May 8, 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. Good afternoon, everyone, and thank you.

Good afternoon, everyone, and thank you for joining us on our first quarter 2025 earnings conference call. We started 2025 with solid financial results and made significant progress on our strategy to comprehensively address the evolving needs of surgeons and patients with an expanding portfolio of best-in-class bunion solutions. Revenue in the first quarter was $52.6 million, representing 3% growth over the first quarter of 2024, and adjusted for one less selling day, growth was 4.5%. As expected, this was a difficult comp, and we are pleased with the overall performance, including early positive validation of our three new bunion systems. We expect 2025 to be a transformational year for Treace Medical Concepts, Inc., and we are incredibly excited about what we will be delivering in the back half of this year and beyond. From the early days of the company, it has been our strategy to evolve our business from a single technology lapoplasty company to a comprehensive bunion solutions company. Since our first cases in 2015, we are proud to have established a strong customer base of over 3,100 surgeon users, treated over 130,000 patients, propelled our company to over $200 million in revenue, and established Treace Medical Concepts, Inc. as the dollar share leader in the U.S. bunion market. Today, our flagship lapoplasty and adductoplasty systems have enabled us to capture on average 25% of our surgeon customers' bunion cases. With the upcoming commercialization of three new best-in-class bunion correction systems, namely our nanoplasty and percuplasty 3D MIS osteotomy systems, and our SpeedMTP MTP fusion system, we gain more immediate and more targeted access to the remaining 75% of our surgeons' cases. So beginning in Q3, we have the opportunity to target virtually 100% of surgeon and patient preferences for bunion correction with five best-in-class instrumented systems addressing all four classes of bunion deformities. In addition, this expanded portfolio allows lapoplasty to appeal to incremental new surgeons who favor osteotomy approaches. The positive feedback from surgeons participating in our limited market releases of these three new systems, as well as strong turnouts we have seen at our initial Bunion Masters surgeon training labs where all five of our systems are now featured, have exceeded our expectations. Additionally, we have high confidence in our inventory timing and volume to support the customer demand for these three new systems, as well as our ability to meet demand going forward. For all of these reasons, we have even greater conviction in the impact these new systems will have on our business starting in the back half of the year. These three new systems will be complemented by expanding commercial availability of several other new technologies, including IntelliGuide PSI, the industry's first and only patient-specific pre-op planning and cut guide solution for lapoplasty, bunion, and adductoplasty midfoot corrections. We have been getting rave reviews from surgeon users on the accuracy and the time savings they are experiencing in their cases with this advanced technology. Our SpeedPlate MicroQuad implant delivers robust dynamic fixation for small incision fusion approaches and provides the enabling implant technology to support driving our microlapoplasty and mini adductoplasty procedures. Our Speed Aiken implant, an ultra-low profile fixation solution for Aiken osteotomies, is performed in high frequency with bunion cases and particularly with MIS osteotomies. We will also be launching several new sterile instruments in the back half of the year. These are complementary procedure-specific tools utilized in our bunion and midfoot cases. And with this expansion of our portfolio, we have been receiving unprecedented interest from experienced foot and ankle sales professionals wanting to join Treace Medical Concepts, Inc. and participate in this next exciting wave of growth for the company. So it is not just the great products we have coming, but the ever-increasing strength of the commercial team we are assembling as we will be pushing this expanded portfolio into the marketplace in the back half of the year. Finally, we are excited to announce plans to initiate a limited market release late in the year of our next-generation lapoplasty platform. Our forthcoming lapoplasty lightning system is another example of our commitment to continuously innovate our flagship systems, making them faster, easier, to deliver an ever-greater experience for our surgeons and their patients. Lightning is more than an incremental improvement. We believe it represents a revolutionary advancement for lapoplasty. We look forward to sharing more details with you on this next-generation system later in the year. As you can see, our R&D engine is running open throttle, delivering a robust pipeline of new technologies that we believe will further extend our market leadership position. As we envisioned from the start, this year we will be establishing Treace Medical Concepts, Inc. as the one-stop shop with a suite of differentiated best-in-class bunion systems that will drive our top-line growth this year into 2026 and beyond. Turning to our outlook, we are reiterating our revenue guidance for 2025. We continue to expect revenue to be between $224 million and $230 million, representing growth of 7% to 10% over the prior year. We anticipate our most substantial growth and contribution to come in the fourth quarter. In addition to seasonal strength driven by the timing of patient deductibles, we will have our new products fully available to more quickly penetrate all bunion classes. As founder of the company, I want to emphasize the significance of this moment. This is the realization of a ten-year vision at Treace Medical Concepts, Inc. to become a focused comprehensive bunion solutions company. And another big step ahead in our mission to improve surgical outcomes for bunion patients. I could not be more proud of the efforts of the entire team here at Treace Medical Concepts, Inc. and the surgeons involved in these projects to bring us to this important milestone. Let me now turn the call over to Mark to review our financial performance.

Thank you, John. Good afternoon, everyone. Revenue in the first quarter was $52.6 million, an increase of $1.5 million or 3% over the prior year period. Adjusted for one less selling day in the quarter, growth was 4.5%, compared to the prior year. Growth was mainly driven by an increase in bunion procedure kits sold compared to the prior year. Gross margin was 79.7% in the first quarter of 2025, compared to 80.2% in the first quarter of 2024. Total operating expenses were $57.5 million in the first quarter of 2025 compared to $59.9 million in the first quarter of 2024. These reductions reflect continued execution on our expense management initiatives. First quarter net loss was $15.9 million or $0.25 per share, compared to a net loss of $18.7 million or $0.30 per share in the first quarter of 2024. Adjusted EBITDA loss in the first quarter was $3.8 million compared to $8.3 million in the first quarter of 2024, an improvement of 54%. This marks our third consecutive quarter of adjusted EBITDA improvements and represents significant progress toward our improved profitability goals of 2025. Cash, equivalents, and marketable securities were $70.1 million as of March 31, 2025, compared to $75.7 million as of December 31, 2024. Total liquidity, including access to an additional $22.5 million of cash through our existing revolver, the balance of cash, cash equivalents, and marketable securities will be approximately $98.6 million as of March 31, 2025. We believe our balance sheet strength and flexibility is sufficient to continue executing our strategic and growth initiatives for the foreseeable future. We are pleased with our cash management efforts and note that the modest cash build in the quarter was due to seasonal timing of cash collections following our seasonally busy fourth quarter and timing of other expenditures. We do not expect this trend to continue through the year due to the seasonality of our business. However, we are pleased with the first quarter results and we continue to focus on improvements. 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. Due to timing variability in scheduling procedures, we anticipate year-over-year growth in Q2 to be consistent with the growth rate in Q2 2024. And for revenue growth rates to step up sequentially in each of the following quarters of the year. We continue to expect breakeven adjusted EBITDA for full year 2025 and expect our cash burn to decrease by approximately 50% for full year 2025 versus 2024. Before we open the lines for Q&A, I would like to touch on our limited tariff exposure. While the majority of our inventory is manufactured in the U.S., we have a reducing portion that is manufactured in Europe and subject to tariffs. We estimate that tariffs will result in an immaterial impact on cost of goods sold in 2025 with additional manufacturing moving to the U.S. this year. We expect our tariff exposure will remain at immaterial levels in 2026 as well. With that, let me now turn the call over to the operator to open the line for your questions.

Thank you. At the start, we will conduct a question and answer session. As a reminder, to ask a question, you will need to press 11 on your telephone. Then just wait for your name to be announced. To withdraw your question, please just press 11 again. Please stand by while we compile the Q&A roster. Our first question today comes from the line of Ryan

Hi, everyone. This is Izzy McMahon on for Ryan

Hi, Izzy McMahon. John Treace here. Thanks for your question. Not a lot has changed on the competitive front as we see it since last quarter. We previously noted there are several companies, big and small, that are participating in the market with lapoplasty knockoffs. That said, those still tend to be these multiline companies that do not have the sole focus and expertise on servicing that bunion procedure and call point like we do. We still believe lapoplasty remains the superior option, the market leader, and gold standard. It is backed by differentiating clinical outcomes data supporting its efficacy, and it is unique in that respect. And we believe we are really well positioned to drive growth and further differentiate ourselves with this new upcoming suite of innovative bunion technologies, including our Speed MTP fusion system and the osteotomy systems. And we are going to be able to play very strongly across all fronts. And then, towards the end of the year, we will follow up with an exciting new development with lapoplasty, initiating our lapoplasty lightning LMR in the fourth quarter.

Understood. That is helpful. And with all of these new product launches, are you starting to see any changes in how quickly you have been able to bring in or train new surgeon users and how quickly those users may be ramping up their utilization of products?

Yes. We certainly have. We have held several of our new Bunion Master training programs through April. Turnouts at these events, where we are featuring all five of our bunion technologies, including the new three systems that we are launching, have been oversold. There is very strong interest. That interest is spreading through the surgeon community to their peers. And it is getting the sales force very excited. I would say the excitement level and the interest that we are seeing is palpable as we await the full launch of these new three systems in the third quarter.

Alright. Thanks for taking the questions.

Sure. Thank you. Our next question comes from the line of Lily Lozada of JPMorgan. Your line is now open.

Great. Thanks so much for taking the question. Maybe I will start with a question on cadence in the second quarter. Just doing the math on the growth that you threw out, I think it implies something like $47 million in sales for the second quarter, which is $2 million to $3 million below the street. So any color on what explains that delta and any specific dynamics in the quarter to keep in mind? And is not that growth a little bit higher as we start to lap the onset of the competitive headwinds that you saw starting last year?

Yeah. Hi, Lily Lozada. This is Mark Hair. Great question, and thanks for asking it. I gave those comments in my remarks really to help with the models and how we see this year playing out. There is a change to the gating. And maybe I will let John Treace talk about what we are seeing in the marketplace and why we are so excited about the back half of the year. But as I said in my remarks, we see Q2 this year to look a lot like last year, growing roughly 6%, and growth to be more back half-weighted in the year when we have more of our new products meeting the highest demand. So for context, yes, there is a shift of about 1% of our overall full-year revenue from Q2 into Q4, into that season that we generally refer to as bunion season. John Treace, maybe I will turn it over to you for some market dynamics.

Sure. Sure, Mark Hair. Yeah. Lily Lozada, what we have been seeing is some foot and ankle procedures, including bunions, being pushed out a little bit. We have seen variability in timing and scheduling of procedures in prior years, and from our experience and consistent with others in the industry, when patients defer elective procedures, those are not lost cases. They usually end up getting their surgeries a bit later in the year where their insurance deductibles have been met. And with the expansion of our portfolio and the timing of that, this dynamic actually plays into our favor. As I mentioned in my opening remarks, today we estimate we are getting on average only around 25% of our surgeons' bunion cases. Starting in Q3 this year, with these three new systems we are going to be bringing into the market, we will be able to more effectively penetrate into the remaining 75% of their cases. So we are going to have five best-in-class solutions that can address virtually 100% of the bunions that our surgeons encounter and also comprehensively address the preferences that their patients may have. So because of all this and the momentum that we have building in the back half, although there are changes in the gating, our views for the full year have not changed.

Got it. That is really helpful. And then just as a follow-up, can you talk a bit about what you are expecting in terms of underlying lapoplasty volumes versus the contribution from some of these new MIS osteotomy products? Do you expect to see any cannibalization of the lapoplasty volumes, and is it fair to assume that lapoplasty growth stays around sort of that low to mid-single-digit growth level that you are seeing in the first half of the year while the MIS osteotomy products drive the acceleration? Any color on how to think about those two buckets would be really helpful. Thanks so much.

Yeah. Great question, Lily Lozada. This is Mark Hair. I will take the first shot at it, and maybe John Treace will follow up as well. You know, we have not broken that out just yet. I think one of the main things to remember right now is we have been in what we call LMRs, or limited market releases, of these new products. So John Treace has talked quite a bit about some of the early reception and what we are seeing with surgeons and the optionality that they have now to approach bunion procedures in many different ways. So we are not right now planning to break that out specifically as we get into the year. I think there are a lot of learnings that we have. But I could say, generally speaking, that you are not too far off to say, right now, we are a company that is primarily a lapoplasty company. And so the growth rates that we are experiencing here are because of what we are able to have in our bag and what our sales reps are able to sell right now, which is primarily lapoplasty. And so as we get into the third quarter, we have these products now becoming more available, we think that can accelerate the growth in the back half of the year. So that is going to be a primary and important driver. Anything else to add on that, John Treace?

No. I think there is minimal cannibalization. These are addressing predominantly, especially in the early phase here, users that have really not had a bias towards lapoplasty or lapidus-type procedures. They prefer to predominantly do osteotomies. And so that is really what we are seeing in our LMR. And I think progressively throughout the year, surgeons already have their algorithm in their minds for how much they are going to apply a lapoplasty or an osteotomy type of product. That is why, in our 3,100 customers, we have surgeons that use lapoplasty for 90% of their bunions, and we have surgeons that use it for 10%. And if you blend them all together, it is around 25%. So by bringing these three new systems out, what we are going to do is fill the void in every one of those customers, whether they are a 10% lapoplasty user or 90%, with a new Treace solution and expand our procedure volumes across our customer base.

Great. Thanks for taking the questions.

Sure thing.

Thank you. Our next question comes from the line of Richard Newitter of Truist Securities. Your line is now open.

Hi. This is Felipe on for Richard Newitter. I was just wondering if you could help us understand how the step-up in hospital outpatient AS reimbursement might have played a role in the first quarter performance and just expectations for the rest of the year. Thank you for taking the question.

Yeah. Yeah, Felipe, thanks. This is John Treace. It is still a little early to tell if and to what degree this is having an impact on our business at this point. That said, it is definitely a positive given the value that we believe lapoplasty and lapoplasty-like procedures bring to patients. We have had some anecdotals of surgeons talking about some positive impacts in the ASC setting early in the year here. These are things like access to our newer technologies, our more premium technologies such as SpeedPlate, but I think it is just a bit too early to quantify the impact of this reimbursement lift at this point in time.

And I guess just to follow up on SpeedPlate, if you could just let us know how that expands your addressable TAM, that would be helpful. I mean, just how that builds incremental momentum throughout the rest of the year. Thanks so much.

Sure. Sure. We continue to drive SpeedPlate. It is the majority of our fixation mix today, and we continue to convert more people from traditional fixation to our SpeedPlate technology. We also are converting a lot of products out there that are offered by other companies. They are known as Nitinol staples, to SpeedPlates because of SpeedPlates' superior strength and fatigue profile. There are a lot of benefits of this technology. We recently announced our MicroQuad launch, and we are increasing our supply of that in the market. This is a really differentiated product that can provide SpeedPlate fixation through small incisions, and small incisions are becoming more and more important. So that works really well hand in hand with our microlapoplasty and mini adductoplasty procedures. And we recently announced the launch of the Speed Aiken, and this is applying our SpeedPlate technology to Aiken osteotomies, which occur in high frequency as a complementary procedure to the original bunion procedure, and they occur at a very high frequency level with MIS osteotomy. So this is an important additive to the bag and increasing our portfolio of options utilizing our SpeedPlate technology.

Alright. So I am showing no further questions at this time. I would now like to turn it back to Tripp Taylor for any closing remarks. And just as I say that, we do have one more question. Stand by. Our next question comes from the line of Jaina Francis of UBS. Your line is now open.

Hi. I am on for Danielle Antalffy today. Congrats on the good quarter here. One question for us is if you could just walk through the assumptions made to get to the top end of the guide and the low end of the guide one more time. Just to help us frame how we are modeling.

Yeah. This is Mark Hair, and thanks for the question. You know, when we start the year off, we commonly say that we are giving a range early in the year. There could be a lot of factors that are happening. We commonly say that we are comfortable at the midpoint of that range. The guide, and I would say that still applies for us at this point. I think there are, on the top end of the range, a lot of the things that John Treace talked about. So as we are transforming from a lapoplasty company into a full suite of comprehensive bunion solutions, including two new MIS solutions and our Speed MTP solution, to the extent we can really drive that at a faster rate, then we could be higher than that midpoint. So that would be the opportunity for us right now. But I think given where we are in the year and that a lot of these products will not be in full supply until the beginning of Q3, I would say the midpoint would be where we would feel comfortable.

Got it. That is helpful. Thank you. And then you are making great strides, and you are committed to the EBITDA breakeven in '25. Could you just talk about the drivers of positive leverage there as we progress through the year?

Yeah. Great question. This is Mark Hair again, and I will start there. It is really a year ago now where we said, we talked about plans to really recommit some of our operational efficiencies in the organization and to manage cash and to look at our expenses. And so we have been managing expenses. We saw a really significant increase in Q3 of last year, as well as Q4. We had the highest amount of adjusted EBITDA in Q4 last year that we have ever had. And so we feel like these efforts are really bearing fruit. We have seen it now in three consecutive quarters. And you could see it throughout the P&L. We are looking for greater efficiencies in the sales and marketing line. We have seen some of those come through, but not really at any expense for our ability to drive the top line. We are looking for efficiencies all the time, and we are continuing, and you can see it on the P&L, that we will be building and adding more capabilities to our R&D function. There is a lot of work that goes into releasing all of these products. So we will continue to look for ways to enhance our R&D capabilities so that we can continue to release these products that we are talking about. John Treace mentioned several products today, even a brand new platform for lapoplasty coming at the end of the year. So that is going to be one of the engines that is going to drive the success of the business. But, you know, I think we are committed to being efficient as a company to improve the profitability, and, you know, we reaffirmed today that we are looking to reduce our cash burn by 50% this year. So I think so far, we are on track for those plans.

Awesome. Thank you.

Thank you. So I am showing no further questions at this time. I would now like to turn it back to Tripp Taylor for any closing remarks.

On behalf of Treace Medical Concepts, Inc., thank you for joining us today. This concludes our call, and we look forward to our next update following the close of the second quarter 2025.