Treace Medical Concepts, Inc.

Good

day and thank you for standing by. Welcome to the Treece Medical Concepts First Quarter 2024 Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1-1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1-1 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker today, Julie Dewey. Please go ahead.

Good afternoon, everyone, and welcome to our first quarter 2024 Earnings Conference Call. We appreciate you joining us. I'm Julie Dewey, Treece's Chief Communications and IR Officer. With me today are John Treece, Chief Executive Officer, and Mark Hare, Chief Financial Officer. During the call, John and Mark will offer commentary on our commercial activity and review our first quarter financial results released after the close of the market today, after which we will host a question and answer session. The press release and supplemental materials can be found in the investor relations section of our website at .treece.com. This call is being recorded and will be archived in the investor section of our website. Before we begin, we'd 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, outlook, 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 current available information, and TREES 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 10Q, for the first quarter 2024 filed today, and our Form 10K for the full year 2023, filed on February 27th, 2024, for a detailed presentation of risks. With that, I will now turn the call over to John.

Thank you, Julie. Good afternoon, everyone, and thanks for joining us. I'm going to focus my comments today on our first quarter 2024 highlights, the progress of our numerous product launches, including Speedplate, our other growth drivers, and then spend some time discussing developments in the market environment, which is underpinning our decision to revise our full-year guidance, as well as tell you about our exciting opportunities and strategies going forward. Following my comments, Mark will cover specifics about our Q1 results and our 2024 guidance. We grew revenue 21% in the first quarter of 2024. Revenue performance was driven by increased procedure kit volume from our expanding base of surgeons and MIX, driven by increased adoption of our newer technologies in our core bunion and related mid-foot cases, all supported by our dedicated direct sales team. We also benefited from strong patient demand trends that extended our seasonally strong fourth quarter into the first quarter. Additionally, we made encouraging progress with respect to our adjusted EBITDA results. Our adjusted EBITDA loss improved 18% to a loss of 8.3 million in the first quarter of 2024, compared to a loss of 10 million for the same period in 2023. We've expanded our position in the foot and ankle market by adding complementary procedures and technologies to treat related deformities, namely our adductoplasy and hammer toe correction systems, both of which coexist frequently with bunions and are addressed at the same time, and which together have expanded our TAM by an estimated $750 million, without diluting our focus on the $5 billion plus US bunion market opportunity. Additionally, exiting Q1, we now have full market availability for a number of our newest technologies, including our speed plate fixation platform, hammer toe system, sterile instruments, and our minimally invasive micro-lapoplasy procedure. We expect all of these new technologies to contribute to our growth going forward. And we recently announced that we've now treated more than 100,000 patients with our lapoplasy procedure, recognizing that our success is not only measured by numbers, but are the transformative change that our differentiated therapies provide to patients to overcome painful lifestyle limiting bunion and related mid-foot deformities. Further highlighting our progress in the first quarter, we delivered gains across our key operating metrics in Q1. We drove a year over year increase in volume of lapoplasy, adductoplasy, and complementary procedures, which were enabled by our versatile speed plate platform. We also benefited from favorable mix as well, with new products like speed plate and our hammer toe systems, as well as our expanded offering of procedure specific sterile instruments, all being utilized more frequently in our core procedures. As we previously announced, we established the first ever National Bunion Day in the United States on April 16th, and we launched our new Future You Patient Education brand awareness campaign. The response of this campaign has been very positive, driving significant increases in our website traffic and an amplified activity level on our -A-Doctor locator. Teresa was also named the first medical device partner and official foot and ankle solution partner for the professional Pickleball Association Tour. Pickleball is the fastest growing sport in the US, and we believe we're uniquely positioned to drive greater awareness of the challenges posed by bunions and educate patients in this demographic on our pioneering lapoplasy procedure, the number one most commonly used 3D bunion correction procedure by US surgeons. Now I'd like to turn to our product launches. Our speed plate launch continues to fuel our growth, and we saw strong demand in the first quarter. In fact, speed plate usage nearly doubled in Q1 versus Q4 of 2023. Exiting Q1, we've achieved full commercialization of speed plate and expect adoption to continue steadily through the remainder of 2024. Additionally, we expect to launch a new speed plate configuration in Q3, which is designed to address some incremental larger bone fusion procedures in the foot. Next, our micro-lapoplasy system. This exciting evolution of our instrumentation allows the patented lapoplasy procedure to be performed now through a two centimeter incision using our new speed plate fixation technology. Our micro-lapoplasy system is now fully available, and throughout Q1, we witnessed a growing number of surgeons utilizing this minimally invasive lapoplasy approach. While we're excited about the growth opportunity that all these product launches represent, there's even more expected to come from our robust product development pipeline to deliver a steady cadence of new innovations in the second half of 2024, including mini-adductoplasty and our Redpoint patient-specific instrumentation. We believe both of these technologies will reinforce our market leadership position in the bunion and related mid-foot correction space. We look forward to providing additional updates on these platforms, as well as other new product innovations as we progress throughout the year. Turning to our guidance. Despite our strong start to the year with expected growth opportunities stemming from product launches and new innovations I just mentioned, it's become clear that the market environment and competitive landscape is quickly evolving, and we've made the decision to revise guidance for fiscal 2024. We have decided to do this now because we're seeing increased use and surgeon adoption of MIS osteotomy solutions. At the same time, we're facing even more competition from knockoffs of our lapoplasy products. Both of these dynamics are creating incremental headwinds to our lapoplasy growth. Specific to these knockoffs, we fundamentally believe that none of these systems match lapoplasy's performance and reproducibility at the surgeon-patient interface, nor are they supported by the strong, differentiating clinical data sets that lapoplasy offers. We also believe some of these competing products are violating our IP. With this backdrop, I'd like to spend the next few minutes reviewing our strategy to expand our offerings and advance our business. While building our leading position in the lapidus segment of the bunion market, we've simultaneously been pursuing a strategy to advance TREES from a company focused solely on lapidus and related solutions to a comprehensive bunion solutions company. Meaning, to implement our strategy to expand our bunion solution portfolio, we plan to launch two innovative 3D MIS osteotomy systems in late 2024 into the meditarsal osteotomy segment of the market, which accounts for 70% of the overall procedure volume today, and into our base of nearly 3,000 surgeon customers. Once launched, our customers who love lapoplasy, but still perform, on average, over half their bunion cases using meditarsal osteotomies, will then have a TREES product to address all of their lapidus and osteotomy bunion cases. Additionally, we expect our MIS osteotomy solutions will afford us the opportunity to appeal to a new group of surgeons, those with a strong bias for using osteotomy approaches for the majority of their bunion patients. We expect to see the positive benefit of these new MIS innovations, starting in the fourth quarter of this year, and ramping throughout 2025. I continue to believe we are uniquely positioned to build upon our market-leading lapoplasy position, while leveraging that position to make a significant impact in the large osteotomy segment of the bunion market. First, we are confident in our track record of developing, commercializing, and rapidly innovating 3D bunion technologies that achieve broad customer acceptance due to their elegant design, reproducibility, and clinical effectiveness. We have proven this with lapoplasy, and we've applied this expertise in our instrumented approach to our 3D MIS osteotomy systems mentioned earlier. And we are confident in our ability to provide a strong educational resource for our surgeon customers, as well as educate patients about our innovative therapies. Again, we have proven this with lapoplasy, and we will apply this experience with our forthcoming 3D MIS osteotomy platforms. Finally, we're confident in our bunion-focused direct sales team's ability to deliver these 3D MIS technologies to our base of nearly 3,000 lapoplasy surgeon users, and continue to expand the size of our surgeon customer base over time. We recently trained an initial group of surgeons on one of our new 3D MIS osteotomy platforms in anticipation of our upcoming limited market release, and the surgeon feedback was overwhelmingly positive. I could not be more excited about the significant opportunity we expect from our new 3D MIS osteotomy platforms. At the same time, we continue to focus on expanding our product offerings and the total market we serve to become a comprehensive bunion solutions company. We are taking decisive actions to mitigate the impact of the competitive challenges, as well as our revised growth rates by right-sizing our P&L and reducing costs. In addition, we intend to assert and enforce our IP rights. I am confident in our ability to capture the opportunities ahead of us, innovate for our surgeon customer base, and deliver value for our shareholders. I'll now turn the call over to Mark to review our first quarter financial performance and provide more details about guidance. Mark?

Thank you, John. Good afternoon, everyone. Revenue for the first quarter of 2024 was 51.1 million, a 21% increase with one less selling day than the prior year. Growth in the first quarter was driven by increased procedure kit volume from our expanding base of surgeons and increased adoption of our newer technologies, all supported by our dedicated direct sales team. As John mentioned, similar to what we saw last year, our seasonally strong fourth quarter extended into the first quarter. This year, there was more carryover from the fourth quarter into the first quarter than originally anticipated, which was the main driver of upside in the quarter. Gross margin was .2% in the first quarter of 2024 compared to .9% in the first quarter of 2023. This decrease was primarily due to a shift in product mix to newer products partially offset by lower royalty rates. Total operating expenses were 59.9 million in the first quarter of 2024 compared to total operating expenses of 47.9 million in the first quarter of 2023. The increase in operating expenses reflects strategic investments in our expanding direct sales channel, investments in product innovation, and support for other corporate initiatives. First quarter net loss was 18.7 million, or 30 cents per share, compared to a net loss of 13.5 million, or 23 cents per share for the same period in 2023. Adjusted EBITDA loss improved 18% to a loss of 8.3 million in the first quarter of 2024 compared to a loss of 10 million for the same period in 2023. Cash, cash equivalents, marketable securities, and investment receivable totaled 112.1 million as of March 31, 2024. We believe we have a lengthy runway in terms of our current cash level with sufficient balance sheet strength and flexibility to continue effectively executing on our strategic investments and growth initiatives for the foreseeable future. Let me now turn to our full year 2024 guidance. As John discussed earlier, we revised our revenue guidance for full year 2024 and now expect revenues of 201 million to 211 million, down from 220 million to 225 million, representing growth of 7% to 13% compared to full year 2023. We continue to anticipate adjusted EBITDA for the full year 2024 to improve approximately 50% compared to the full year 2023. Given our revised guidance, we now expect relatively flat year over year revenue growth in Q2 and high single digit revenue growth in Q3 and in Q4 versus the prior year. Now, before we open up the call for questions, let me turn it back to John for some concluding comments. John?

Thanks, Mark. As we wrap up, I wanna take a minute to highlight what we believe to be the key takeaways from this call. Looking ahead, Teresa's evolution from a purely Lapidus-focused company to a comprehensive bunion solution company is underway and on track. We continue to be relentlessly driven by our mission to advance the standard of care and are innovating to meet demand for certain customers and their patients. I'm confident we have the right team in place to navigate the current market challenges we face, achieve our ambitious goals, and ultimately deliver long-term value to our shareholders. With that, now let me turn the call over to the operator to open the line for your questions.

Thank you. At this time, we will conduct the question and answer session. As a reminder, to ask a question, you will need to press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. Please stand by while we compile the Q&A roster. Our first question comes from the line of Robbie Marcus of JPMorgan. Your line is now open.

Hi, this is actually Lily for Robbie. Thanks for taking the question. Maybe just starting with the competitive dynamics. What changed? It sounds like for a really long time, you really weren't seeing any competitive impact at all, and now all of a sudden it's created this pretty meaningful impact to your momentum. So what happened there, and can you give your, or talk about your confidence and your ability to recapture some of that share loss that you're seeing, especially given you're going up against several larger Olympic players.

Hi, Lily, John Therese here. As we talked about competition in the past, what we've stated is we know there are more competitors entering the market. We recognize there's competition, but that we had yet to see anything that was of a significant headwind that would thwart our ability to hit our communicated revenue targets. What we're communicating here, and with this revised guide, is that we now are feeling that type of competitive pressure that is creating a headwind. So that's why we had to make the guide change. We've discussed the increased use of MIS osteotomies in the marketplace, which we believe we have a great solution for later in this year. And specific to lapoplasty, we've seen competitors become a little more aggressive with getting doctors to trial these alternative products, and that's another headwind. Surgeons like to often evaluate new things, and there's just a lot of them out there to try right now. So it's hard to say how many of these surgeons will try it for a competitive product, for a while, and then ultimately come back to lapoplasty, and then how many might fully convert and stick with a competitive offering. We've seen a lot of these scenarios where surgeons evaluate other systems, and they do come back to lapoplasty, but it definitely creates some headwinds. But fundamentally, we believe that as we get more of our osteotomy MIS sets into the market over time, late this year, along with our other planned launches, this should put us in a much stronger position, as we'll have a comprehensive suite of bunion offerings to bring to our base of nearly 3,000 lapoplasty users who on average are using osteotomies for half or more other cases. So I think we've got a great plan in place. We've got a little bit of a headwind here for the next couple quarters, and we'll look forward to those launches at the end of the year.

Got it, that's helpful. And then maybe just to follow up on that, I appreciate that you're not breaking out kits and physician count and ASP anymore, but can you talk through which of those pieces is really the driver of the step down? Are you not able to train as many physicians? Is utilization declining? Is it the ancillary products that you're not able to tack on as much? So how should we qualitatively, I guess, be thinking about all those pieces moving forward? Thank you.

Yeah, Lily, this is Mark. Maybe I'll take a first shot, and then John can add any incremental thoughts. You talked about the growth and what is really driving that growth. It came from two things, as we talked about. It's coming from incremental kit volume, as well as mix. And that mix is involving these new products that John talked about. We have Speedplate, which is a premium price product. We have Hammertoe. We have these incremental complimentary products, is the Stereolus instruments that are used in the procedures. So it's really coming, the 21% growth in Q1 really came from both, both volume as well as mix.

One more. Lily.

Oh, sorry, it might've been on you.

I was more asking for the full year. So how should we be thinking about how those pieces play into the lower guide, appreciating that you're not breaking them out specifically, but qualitatively, what's moving lower in those buckets? Thanks.

Yeah, so that's a great question. So what we will continue to see is increases in both volume as well as our blended ASP. We've been talking last year, we saw a lot of uplift in what we referred to as blended ASP, meaning that's really the mix and our new product launches that are used at the same time as our core LAPAplasty procedures. So we will continue to benefit that from that product mix and new product offerings this year, but we will continue to see volume increases as well. So it's going to come from both the volume increases and then the incremental products. So what we saw in Q1, maybe not at the same growth rate, but we're going to see similar growth from both.

Got it, thank you.

One moment for our next question. Thank you. Our next question comes from the line of Richard Newiter of Truis Securities. Your line is now open.

Hi, thanks for taking the questions. Just the first one, it sounds like you're experiencing stepped up competition from the knockoff bucket on your core LAPAplasty offering. So what just do we think in the updated outlook, are we just supposed to view it as, you continue to see that priling and that competition getting worse and then you offset that with some of the continued mix items to some extent from the growing portfolio and then we buy time until the MIS offerings and osteotomy come and that's kind of the call down on the outlook or I'm just trying to understand what the trend is on the core LAPAplasty competitive situation of the next two to three quarters before you even have an offering to start to make inroads on the MIS, osteotomy piece.

Yeah, Rich, this is Mark. I think the way you articulated it to begin with is right that we see continued competition from competitors in the LAPA space that are competing directly with LAPAplasty. We have a tougher comp in Q2 and we have easier comps in Q3 and Q4 and we expect to see some benefit from these new product launches in the back half of this year so that's gonna help us with the growth in the back half.

Okay, and then just as we think of the, obviously it's a slower top line growth trajectory but it sounds like you're gonna accommodate the PNL accordingly. Can you talk a little bit just about how you plan to manage the PNL? I see that your updated EBITDA guidance is relatively unchanged and it's going to increase 50% year over year. How much control do you have over the levers there and it sounds like you need to step up spending as you're exiting the year so just help me reconcile that. Thanks.

Yeah, so Rich, we're evaluating all these opportunities to reduce costs and we're confident that we can definitely manage them. Based on our lower revenue guide, if you take the midpoint or based on the lower guide, there's a healthy component of the cost reductions that come very naturally from reduced variable expenses related to cogs, commissions, corporate incentives and then the remaining expenses are discretionary in nature that we know that we can manage and will impact our business longer term so we're a nimble company, we're nimble enough that we can operate the PNL effectively without losing sight on our core opportunities so we feel comfortable with that PNL guidance. Okay, thanks.

One moment for our next question. Thank you. Our next question comes from the line of Drew Ranieri of Morgan Stanley. Your line is now open.

Hi, John and Mark, thanks for taking the questions. Maybe just to, again, revisit the competition again. Both, you mentioned you're at about 3,000 surgeons now so maybe just hone in on this a little bit more and kind of like what you're seeing in your surgeon base and I think we're also all kind of struggling to see or really understand that the seven to 13% growth guidance that you're giving now is really de-risked for the competition at this point. Like why should we be confident that this is the right range? What are you seeing that

maybe help instill that? Yeah, hi, Drew, John.

I think we feel pretty good about the guide. We've definitely got some headwinds but we also have tailwinds. We're still adding new surgeons but some of the volume that our surgeons were doing are being taken by some of the competitive trials, some to MIS osteotomy. So we're just seeing a, we plan to continue to add new surgeons. It's just that the efficiency we're getting per surgeon is a little reduced. And then there's some churn there as some may decide to go with a competitive product mid or longer term. Is that, I think that anything else I missed there, Mark? Yeah, and

we feel really good. I mentioned it a little bit earlier that the clumps are much lighter in Q2, excuse me, in Q3 and Q4. So that gives us additional confidence and then having these new product lines that have been, we've been working on for a long time here. We've developed some great products, not by ourselves. We've used a great surgeon advisory group to help us build these new MIS products. We've got, John also mentioned we have other things that, we've been talking about for a while coming. We've got a Redpoint products. We have a new Speedplate design that's coming. And we have other things as well that were always coming in the back half of the year with easier comps. So we feel good about the guide and that it's been properly de-risked.

Okay, got it. And again, just with the surgeons, can you talk about maybe like what attrition rate you're maybe seeing in the surgeon base at this point, compare that maybe to historical levels. And when we do think about the surgeon base, I mean, where in the curve or the adoption curve are you kind of seeing the most impact within the kind of the competition dynamic? I mean, is this happening more to like your year one, year two, year three surgeons, or is this getting into even some more of your tenured base?

Yeah, great question, Drew. So, we've talked about that. We said last year that we plan to grow 250 to 300 surgeons this year. We're well on track with that. We continue to add surgeons. They fuel current and future growth. And so we continue to do that. What we're seeing is that it's not so much an attrition rate, it's more of how often are they going to use our lapoplasty, this lapidus solution in the OR. And to the extent there are competing products, both from an MIS perspective, that's the osteotomy. It's a different approach altogether to the bunion correction. Or if there's other lapidus type solutions, there's just a lot more of them. And so we're seeing that. We continue to add new surgeons. They continue to do what we're expecting them to do in that first year. But we're seeing some of our more tenured surgeons who have been using other options rather than lapoplasty exclusively.

That is all. I'll hop back in queue, thanks. Thanks.

As a reminder, to ask a question, you will need to press star 1-1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1-1 again. One moment for our next question. Thank you. Our next question comes from the line of Harrison Parsons of Stevens. Your line is now open.

Hi, Joanna Mark. This is Harrison on for George. Good afternoon and thanks for taking the questions. I wanted to start on ride sizing the P&L. I was wondering if you could just expand a little bit on costs or areas that you could see costs take out. Is this primarily in the sales and marketing line or are there other areas we could see some leverage in 2024?

Hey Harrison, this is Mark. Great question. You know, as I did mention before that when there is lower revenue, there's a fair and healthy portion of costs that come out because they're purely variable in nature. And so there will be reductions in that sales and marketing line item, just because that's where a lot of the variable expenses come from. But there will also be some overall reductions throughout the P&L. But again, we believe that those are gonna be discretionary spending items and that we're definitely nimble enough that we can operate the P&L effectively and without losing sight on all these commercial initiatives and programs and launches that we're talking about. So it's, yes, there will be some that are variable in the sales and marketing line, but it will impact some of the G&A and R&D as well.

Okay,

yeah, sounds good. And then in terms of protecting your IP, I was wondering if, because I mean, I guess I know there's been competition for a while, has there been a new product or is there something specific to go after there? And kind of what's the game plan in terms of protecting that IP?

Yeah, Harrison, John here. You know, we're really not gonna comment much on our IP strategy timing, but as and when things may happen, we will communicate to you as we progress.

Understood, thanks for taking the questions. Thank you.

One moment for our next question.

Thank you. Our next question comes from the line of Danielle Antaufi of UBS. Your line is now open.

Hey, John and Mark, this is Simon again on for Danielle. Thanks for taking the question. When you think about the competition that you're, when you think about the competition that you're currently facing, is this coming in the form of larger competitive headwinds from surgeons not converting over from osteotomies or is this purely from the competitive lapoplasty products? Just wanna know how we should think about that.

Yes, Simon, John here. You know, it's really not one competitor per se, but it's an amalgamation of a number of competitors, big companies, small companies, public and private, you know, that are now selling products intended to directly compete with lapoplasty. Several of those companies also offer MIS osteotomy products, which as of this time, we do not have, but that's a temporary situation for us. And there are more competitors today than there were last year. But we're focused on effectively navigating this market environment and continue to work to capture opportunities ahead and innovate for our surgeon base. And we've got a great MIS osteotomy platform coming in Q4, and we're very excited about the capabilities that we'll have in transforming Thrice Medical into a full line bunion product company and feeling the next leg of the growth of this business.

That's really helpful. And just a quick follow up for you. There were a couple of comments on how efficiency per surgeon has come in and maybe a bit less than expectations. Do we think that this is impacting, I guess maybe your future targets for total lapoplasty penetration growth? And how should we think about this impacting utilization over the next, I guess, over the near term?

Yeah, that's a great question. You know, one thing that we continue to see is a nice steady uptick of surgeon, net surgeon ads. So we continue, we had 475 ads last year. We've had a lot of surgeon ads. We've had healthy surgeon additions this year as well. So we continue to see that. It's been more of, you know, surgeons have always had the option of how to approach bunions. And so we believe that lapoplasty provides a great solution. We have a lot of clinical data. We believe more than any other lapidus type solution. And so we have a lot of confidence that our lapoplasty solution gives great results and it's elegantly designed for surgeons. We constantly and regularly hear how much they appreciate the design in the OR. We've made it faster and more effective and more efficient. However, surgeons have always had the option of whether or not they're going to approach a patient surgery with a lapidus procedure or an osteotomy. And there have been some differences between the two approaches. And so we continue to see that in some surgeons or continue to use lapoplasty, but may decide that maybe the percentage of the lapidus or the lapoplasty procedures in their overall patient base is shifting a little bit. So it's more of that. I don't want to say that's the answer for every surgeon because every surgeon is different, but we've definitely seen a trend that MIS osteotomies are more and more of the overall procedure base.

And Mark, I think that's why we're pretty excited about this upcoming MIS osteotomy program that we're going to be launching because now we can be the solution provider for those cases that they're opting to do MIS osteotomies on today instead of a lapoplasty potentially.

Julia,

operator, are

you there?

Yes, I am. I'm showing no further questions at this time. I would now like to turn it back to Julie Dewey for closing remarks.

Thank you. And thanks everybody for joining us today. We appreciate your time and interest. If you have more questions, please reach out and we'll look forward to talking to you next quarter. This concludes our call.

Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.

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you. Thank you. Good day and thank you for standing by. Welcome to the Treece Medical Concepts first quarter 2024 earnings conference call. At this time, all participants are in a listen only mode. After the speaker's presentation, there'll be a question and answer session. To ask a question during the session, you will need to press star one one on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star one one again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker today, Julie Dewey. Please go ahead.

Good afternoon everyone and welcome to our first quarter 2024 earnings conference call. We appreciate you joining us. I'm Julie Dewey, Treece's Chief Communications and IR Officer. With me today are John Treece, Chief Executive Officer and Mark Hare, Chief Financial Officer. During the call, John and Mark will offer commentary on our commercial activity and review our first quarter financial results released after the close of the market today, after which we will host a question and answer session. The press release and supplemental materials can be found in the investor relations section of our website at .treece.com. This call is being recorded and will be archived in the investor section of our website. Before we begin, we'd 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, outlook 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 current available information and TREES 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 10Q for the first quarter 2024 filed today, and our Form 10K for the full year 2023 filed on February 27th, 2024 for a detailed presentation of risks. With that, I will now turn the call over to John.

Thank you, Julie. Good afternoon, everyone, and thanks for joining us. I'm going to focus my comments today on our first quarter 2024 highlights, the progress of our numerous product launches, including Speedplate, our other growth drivers, and then spend some time discussing developments in the market environment, which is underpinning our decision to revise our full year guidance, as well as tell you about our exciting opportunities and strategies going forward. Following my comments, Mark will cover specifics about our Q1 results and our 2024 guidance. We grew revenue 21% in the first quarter of 2024. Revenue performance was driven by increased procedure kit volume from our expanding base of surgeons and MIX driven by increased adoption of our newer technologies in our core bunion and related mid-foot cases, all supported by our dedicated direct sales team. We also benefited from strong patient demand trends that extended our seasonally strong fourth quarter into the first quarter. Additionally, we made encouraging progress with respect to our adjusted EBITDA results. Our adjusted EBITDA loss improved 18% to a loss of 8.3 million in the first quarter of 2024, compared to a loss of 10 million for the same period in 2023. We've expanded our position in the foot and ankle market by adding complimentary procedures and technologies to treat related deformities, namely our adductoplasy and hammer toe correction systems, both of which coexist frequently with bunions and are addressed at the same time, and which together have expanded our TAM by an estimated $750 million, without diluting our focus on the $5 billion plus US bunion market opportunity. Additionally, exiting Q1, we now have full market availability for a number of our newest technologies, including our speed plate fixation platform, hammer toe system, sterile instruments, and our minimally invasive micro-lapoplasy procedure. We expect all of these new technologies to contribute to our growth going forward. And we recently announced that we've now treated more than 100,000 patients with our lapoplasy procedure, recognizing that our success is not only measured by numbers, but are the transformative change that our differentiated therapies provide to patients to overcome painful lifestyle limiting bunion and related mid-foot deformities. Further highlighting our progress in the first quarter, we delivered gains across our key operating metrics in Q1. We drove a year over year increase in volume of lapoplasy, adductoplasy, and complementary procedures, which were enabled by our versatile speed plate platform. We also benefited from favorable mix as well, with new products like speed plate and our hammer toe systems, as well as our expanded offering of procedure specific sterile instruments, all being utilized more frequently in our core procedures. As we previously announced, we established the first ever National Bunion Day in the United States on April 16th, and we launched our new Future You Patient Education Brand Awareness Campaign. The response to this campaign has been very positive, driving significant increases in our website traffic and an amplified activity level on our -A-Doctor locator. Teresa was also named the first medical device partner and official foot and ankle solution partner for the professional Pickleball Association Tour. Pickleball is the fastest growing device growing sport in the US, and we believe we're uniquely positioned to drive greater awareness of the challenges posed by bunions and educate patients in this demographic on our pioneering lapoplasy procedure, the number one most commonly used 3D bunion correction procedure by US surgeons. Now I'd like to turn to our product launches. Our speed plate launch continues to fuel our growth, and we saw strong demand in the first quarter. In fact, speed plate usage nearly doubled in Q1 versus Q4 of 2023. Exiting Q1, we've achieved full commercialization of speed plate and expect adoption to continue steadily through the remainder of 2024. Additionally, we expect to launch a new speed plate configuration in Q3, which is designed to address some incremental larger bone fusion procedures in the foot. Next, our micro-lapoplasy system. This exciting evolution of our instrumentation allows the patented lapoplasy procedure to be performed now through a two centimeter incision using our new speed plate fixation technology. Our micro-lapoplasy system is now fully available, and throughout Q1, we witnessed a growing number of surgeons utilizing this minimally invasive lapoplasy approach. While we're excited about the growth opportunity that all these product launches represent, there's even more expected to come from our robust product development pipeline to deliver a steady cadence of new innovations in the second half of 2024, including mini-adductoplasy and our Red Point patient-specific instrumentation. We believe both of these technologies will reinforce our market leadership position in the bunion and related mid-foot correction space. We look forward to providing additional updates on these platforms, as well as other new product innovations as we progress throughout the year. Turning to our guidance. Despite our strong start to the year, with expected growth opportunities stemming from product launches and new innovations I just mentioned, it's become clear that the market environment and competitive landscape is quickly evolving, and we've made the decision to revise guidance for fiscal 2024. We have decided to do this now because we're seeing increased use and surgeon adoption of MIS osteotomy solutions. At the same time, we're facing even more competition from knockoffs of our lapoplasy products. Both of these dynamics are creating incremental headwinds to our lapoplasy growth. Specific to these knockoffs, we fundamentally believe that none of these systems match lapoplasy's performance and reproducibility at the surgeon-patient interface, nor are they supported by the strong, differentiating clinical data sets that lapoplasy offers. We also believe some of these competing products are violating our IP. With this backdrop, I'd like to spend the next few minutes reviewing our strategy to expand our offerings and advance our business. While building our leading position in the lapidus segment of the bunion market, we've simultaneously been pursuing a strategy to advance trees from a company focused solely on lapidus and related solutions to a comprehensive bunion solutions company. Meaning, to implement our strategy to expand our bunion solution portfolio, we plan to launch two innovative 3D MIS osteotomy systems in late 2024 into the meditarsal osteotomy segment of the market, which accounts for 70% of the overall procedure volume today, and into our base of nearly 3,000 surgeon customers. Once launched, our customers who love lapoplasy, but still perform on average over half their bunion cases using meditarsal osteotomies will then have a tree's product to address all of their lapidus and osteotomy bunion cases. Additionally, we expect our MIS osteotomy solutions will afford us the opportunity to appeal to a new group of surgeons, those with a strong bias for using osteotomy approaches for the majority of their bunion patients. We expect to see the positive benefit of these new MIS innovations starting in the fourth quarter of this year and ramping throughout 2025. I continue to believe we are uniquely positioned to build upon our market-leading lapoplasy position while leveraging that position to make a significant impact in the large osteotomy segment of the bunion market. First, we are confident in our track record of developing, commercializing, and rapidly innovating 3D bunion technologies that achieve broad customer acceptance due to their elegant design, reproducibility, and clinical effectiveness. We have proven this with lapoplasy and we've applied this expertise in our instrumented approach to our 3D MIS osteotomy systems mentioned earlier. And we are confident in our ability to provide a strong educational resource for our surgeon customers, as well as educate patients about our innovative therapies. Again, we have proven this with lapoplasy and we will apply this experience with our forthcoming 3D MIS osteotomy platforms. Finally, we're confident in our bunion-focused direct sales team's ability to deliver these 3D MIS technologies to our base of nearly 3,000 lapoplasy surgeon users and continue to expand the size of our surgeon customer base over time. We recently trained an initial group of surgeons on one of our new 3D MIS osteotomy platforms in anticipation of our upcoming limited market release and the surgeon feedback was overwhelmingly positive. I could not be more excited about the significant opportunity we expect from our new 3D MIS osteotomy platforms. At the same time, we continue to focus on expanding our product offerings and the total market we serve to become a comprehensive bunion solutions company. We are taking decisive actions to mitigate the impact of the competitive challenges, as well as our revised growth rates by right sizing our P&L and reducing costs. In addition, we attend to assert and enforce our IP rights. I am confident in our ability to capture the opportunities ahead of us, innovate for our surgeon customer base, and deliver value for our shareholders. I'll now turn the call over to Mark to review our first quarter financial performance and provide more details about guidance. Mark?

Thank you, John. Good afternoon, everyone. Revenue for the first quarter of 2024 was 51.1 million, a 21% increase with one less selling day than the prior year. Growth in the first quarter was driven by increased procedure kit volume from our expanding base of surgeons and increased adoption of our newer technologies, all supported by our dedicated direct sales team. As John mentioned, similar to what we saw last year, our seasonally strong fourth quarter extended into the first quarter. This year, there was more carryover from the fourth quarter into the first quarter than originally anticipated, which was the main driver of upside in the quarter. Gross margin was .2% in the first quarter of 2024 compared to .9% in the first quarter of 2023. This decrease was primarily due to a shift in product mix to newer products partially offset by lower royalty rates. Total operating expenses were 59.9 million in the first quarter of 2024 compared to total operating expenses of 47.9 million in the first quarter of 2023. The increase in operating expenses reflects strategic investments in our expanding direct sales channel, investments in product innovation, and support for other corporate initiatives. First quarter net loss was 18.7 million, or 30 cents per share, compared to a net loss of 13.5 million, or 23 cents per share for the same period in 2023. Adjusted EBITDA loss improved 18% to a loss of 8.3 million in the first quarter of 2024 compared to a loss of 10 million for the same period in 2023. Cash, cash equivalents, marketable securities, and investment receivable totaled 112.1 million as of March 31, 2024. We believe we have a lengthy runway in terms of our current cash level with sufficient balance sheet strength and flexibility to continue effectively executing on our strategic investments and growth initiatives for the foreseeable future. Let me now turn to our full year 2024 guidance. As John discussed earlier, we revised our revenue guidance for full year 2024 and now expect revenues of 201 million to 211 million, down from 220 million to 225 million, representing growth of 7% to 13% compared to full year 2023. We continue to anticipate adjusted EBITDA for the full year 2024 to improve approximately 50% compared to the full year 2023. Given our revised guidance, we now expect relatively flat -over-year revenue growth in Q2 and high single-digit revenue growth in Q3 and in Q4 versus the prior year. Now, before we open up the call for questions, let me turn it back to John for some concluding comments. John? Thanks, Mark.

As we wrap up, I want to take a minute to highlight what we believe to be the key takeaways from this call. Looking ahead, Teresa's evolution from a purely Lapidus-focused company to a comprehensive bunion solution company is underway and on track. We continue to be relentlessly driven by our mission to advance the standard of care and are innovating to meet demand for certain customers and their patients. I'm confident we have the right team in place to navigate the current market challenges we face, achieve our ambitious goals, and ultimately deliver long-term value to our shareholders. With that, now let me turn the call over to the operator to open the line for your questions.

Thank you. At this time, we will conduct the question and answer session. As a reminder, to ask a question, you will need to press star 1-1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1-1 again. Please stand by while we compile the Q&A roster. Our first question comes from the line of Robbie Marcus of JPMorgan. Your line is now open.

Hi, this is actually Lily for Robbie. Thanks for taking the question. Maybe just starting with the competitive dynamics. What changed? It sounds like for a really long time, you really weren't seeing any competitive impact at all, and now all of a sudden it's created this pretty meaningful, impact to your momentum. So what happened there? And can you give your, or talk about your confidence and your ability to recapture some of that share loss that you're seeing, especially given you're going up against several larger or so players?

Yeah, hi Lily, John, John Treese here. You know, as we talked about competition in the past, you know, what we've stated is, we know there are more competitors entering the market. We recognize there's competition, but that we had yet to see anything that was of a significant headwind that would thwart our ability to hit our communicated revenue targets. What we're communicating here, and with this revised guide, is that we now are feeling that type of competitive pressure that is creating a headwind. So that's why we had to make the guide change. We've discussed the increased use of MIS osteotomies in the marketplace, which we believe we have a great solution for later in this year. And specific to lapoplasty, we've seen competitors become a little more aggressive with getting doctors to trial these alternative products, and that's another headwind. And you know, surgeons like to often evaluate new things, and there's just a lot of them out there to try right now. So it's hard to say how many of these surgeons will try it for a competitive product, for a while, and then ultimately come back to lapoplasty, and then how many might fully convert and stick with a competitive offering. We've seen a lot of these scenarios where surgeons evaluate other systems, and they do come back to lapoplasty, but it definitely creates some headwinds. But fundamentally, we believe that as we get more of our osteotomy MIS sets into the market over time, late this year, along with our other planned launches, this should put us in a much stronger position, as we'll have a comprehensive suite of bunion offerings to bring to our base of nearly 3,000 lapoplasty users who on average are using osteotomies for half or more other cases. So I think we've got a great plan in place. We've got a little bit of a headwind here for the next couple quarters, and we'll look forward to those launches at the end of the year.

Got it, that's helpful. And then maybe just to follow up on that, I appreciate that you're not breaking out kits and physician count and ASP anymore, but can you talk through which of those pieces is really the driver of the step down? Are you not able to train as many physicians? Is utilization declining? Is it the ancillary products that you're not able to tack on as much? So how should we qualitatively, I guess, be thinking about all those pieces moving forward? Thank you.

Yeah, Lily, this is Mark. Maybe I'll take a first shot, and then John can add any incremental thoughts. You talked about the growth and what is really driving that growth. It came from two things, as we talked about. It's coming from incremental kit volume, as well as mix. And that mix is involving these new products that John talked about. We have Speedplate, which is a premium price product. We have Hammertoe. We have these incremental complimentary products, Steriluos instruments that are used in the procedures. So it's really coming, the 21% growth in Q1 really came from both, both volume as well as mix.

One more. Lily? Oh, sorry, it might've been on you.

I was more asking for the full year. So how should we be thinking about how those pieces play into the lower guide? Appreciating that you're not breaking them out specifically, but qualitatively, what's moving lower in those buckets? Thanks.

Yeah, so that's a great question. So what we will continue to see is increases in both volume as well as our blended ASP. We've been talking last year, we saw a lot of uplift in what we referred to as blended ASP, meaning that's really the mix and our new product launches that are used at the same time as our core LAPAplasty procedures. So we will continue to benefit that from that product mix and new product offerings this year, but we will continue to see volume increases as well. So it's going to come from both the volume increases and then the incremental products. So what we saw in Q1, maybe not at the same growth rate, but we're gonna see similar growth from both.

Got it, thank you.

One moment for our next question. Thank you, our next question comes from the line of Richard Neuwitter of Truis Securities. Your line is now open.

Hi, thanks for taking the questions. Just the first one, it sounds like you're experiencing stepped up competition from the knockoff bucket on your core LAPAplasty offering. So what just do we think in the updated outlook, are we just supposed to view it as you continue to see that priling and that competition getting worse and then you offset that with some of the continued mix items to some extent from the growing portfolio and then we buy time until the MIS offerings and osteotomy come. And that's kind of the call down on the outlook or I'm just trying to understand what the trend is on the core LAPAplasty competitive situation of the next two to three quarters before you even have an offering to start to make inroads on the MIS, osteotomy piece.

Yeah, Rich, this is Mark. I think the way you articulated it to begin with is right that we see continued competition from competitors in the LAPA space that are competing directly with LAPAplasty. We have a tougher comp in Q2 and we have easier comps in Q3 and Q4 and we expect to see some benefit from these new product launches in the back half of this year. So that's gonna help us with the growth in the back half.

Okay, and then just as we think of the, obviously it's a slower top line growth trajectory but it sounds like you're gonna accommodate the P&L accordingly. Can you talk a little bit just about how you plan to manage the P&L? I see that your updated EBITDAG guidance is relatively unchanged on a, it's going to increase 50% year over year. How much control do you have over the levers there? And it sounds like you need to step up spending as you're exiting the year. So just help me reconcile that. Thanks.

Yeah. So Rich, we're evaluating all these opportunities to reduce costs and we're confident that we can definitely manage them. Based on our lower revenue guide, if you take the midpoint or based on the lower guide, there's a healthy component of the cost reductions that come very naturally from reduced variable expenses related to COGS, commissions, corporate incentives and then the remaining expenses are discretionary in nature that we know that we can manage and will impact our business longer term. So we're a nimble company. We're nimble enough that we can operate the P&L effectively without losing sight on our core opportunities. So we feel comfortable with that P&L guidance. Okay, thanks.

One moment for our next question. Thank you. Our next question comes from the line of Drew Ranieri of Morgan Stanley. Your line is now open.

Hi, John and Mark. Thanks for taking the questions. Maybe just to, again, revisit the competition again. Both you mentioned you're at about 3,000 surgeons now. So maybe just hone in on this a little bit more and kind of like what you're seeing in your surgeon base. And I think we're also all kind of struggling to see or really understand that the seven to 13% growth guidance that you're giving now is really de-risked for the competition at this point. Like why should we be confident that this is the right range? What are you seeing that

maybe help instill that? Yeah, hi, Drew, John.

I think we feel pretty good about the guide. We definitely got some headwinds, but we also have tailwinds. We're still adding new surgeons, but some of the volume that our surgeons were doing are being taken by some of the competitive trials, some to be done in the next few weeks. So we're seeing a, we plan to continue to add new surgeons. It's just that the efficiency we're getting per surgeon is a little reduced. And then there's some churn there as some may decide to go with a competitive product mid or longer term. So is that anything else I missed there, Mark? Yeah, and

we feel really good. I mentioned it a little bit earlier that the clumps are much lighter in Q2, excuse me, in Q3 and Q4. So that's going to, that gives us additional confidence. And then having these new product lines that have been, we've been working on for a long time here. We've developed some great products, not by ourselves. We've used a great surgeon advisory group to help us build these new MIS products. We've got, John also mentioned we have other things that, we've been talking about for a while coming. We've got a Redpoint products. We have a new Speedplate design that's coming. And we have other things as well that we're always coming in the back half of the year with easier comps. So we feel good about the guide and that it's been properly de-risked.

Okay, got it. And again, just with the surgeons, can you talk about maybe like what attrition rate you're maybe seeing in the surgeon base at this point, compare that maybe to historical levels? And when we do think about the surgeon base, I mean, where in the curve or the adoption curve are you kind of seeing the most impact within the kind of the competition dynamic? I mean, is this happening more to like your year one, year two, year three surgeons, or is this getting into even some more of your tenured base?

Yeah, great question, Drew. So, we've talked about that, we said last year that we plan to grow 250 to 300 surgeons this year, we're well on track with that. We continue to add surgeons, they fuel current and future growth. And so we continue to do that. What we're seeing is that it's not so much an attrition rate, it's more of how often are they going to use our lapoplasty, this lapidus solution in the OR. And to the extent there are competing products, both from an MIS perspective, that's the osteotomy, it's a different approach altogether to the bunion correction. Or if there's other lapidus type solutions, there's just a lot more of them. And so we're seeing that we continue to add new surgeons, they continue to do what we're expecting them to do in that first year, but we're seeing some of our more tenured surgeons who have been using other options rather than lapoplasty exclusively.

I'll hop back in queue, thanks. Thanks.

As a reminder, to ask a question, you will need to press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. One moment for our next question. Thank you. Our next question comes from the line of Harrison Parsons of Stevens. Your line is now open.

Hi, John and Mark, this is Harrison on for George. Good afternoon and thanks for taking the questions. I wanted to start on ride sizing the P&L. I was wondering if you could just expand a little bit on costs or areas that you could see costs take out. Is this primarily in the sales to marketing line or are there other areas we could see some leverage in 2024?

Hey Harrison, this is Mark, great question. As I did mention before that when there is lower revenue, there's a fair and healthy portion of costs that come out because they're purely variable in nature. And so there will be reductions in that sales and marketing line item just because that's where a lot of the variable expenses come from, but there will also be some overall reductions throughout the P&L. But again, we believe that those are gonna be discretionary spending items and that we're definitely nimble enough that we can operate the P&L effectively and without losing sight on all these commercial initiatives and programs and launches that we're talking about. So it's yes, there will be some that are variable in the sales and marketing line, but it will impact some of the G&A and R&D as well.

Okay,

yeah, sounds good. And then in terms of protecting your IP, I was wondering if, cause I mean, I guess I know there's been competition for a while, has there been a new product or is there something specific to go after there and kind of what's the game plan in terms of protecting that IP?

Yeah, Harrison, John here. We're really not gonna comment much on our IP strategy timing, but as and when things may happen, we will communicate to you as we progress.

Understood, thanks for taking the questions. Thank you.

One moment for our next question.

Thank you. Our next question comes from the line of Danielle Antaufi of UBS. Your line is now open.

Hey John and Mark, this is Simon Agenon for Danielle. Thanks for taking the question. When you think about the competition that you're, when you think about the competition that you're currently facing, is this coming in the form of larger competitive headwinds from surgeons not converting over from osteotomies or is this purely from the competitive lapoplasty products? Just wanna know how we should think about that.

Yes, Simon, John here. It's really not one competitor per se, but it's an amalgamation of a number of competitors, big companies, small companies, public and private that are now selling products intended to directly compete with lapoplasty. Several of those companies also offer MIS osteotomy products, which as of this time, we do not have, but that's a temporary situation for us. And there are more competitors today than there were last year, but we're focused on effectively navigating this market environment and continue to work to capture opportunities ahead and innovate for our surgeon base. And we've got a great MIS osteotomy platform coming in Q4 and we're very excited about the capabilities that we'll have in transforming Therese Medical into a full-line bunion product company and fueling the next leg of the growth of this business.

That's really helpful. And just a quick follow-up for you. There were a couple comments on how efficiency per surgeon has come in maybe a bit less than expectations. Do we think that this is impacting, I guess maybe your future targets for total lapoplasty penetration growth and how should we think about this impacting utilization over the next, I guess over the near term?

Yeah, that's a great question. You know, one thing that we continue to see is a nice steady uptick of net surgeon ads. So we continue, we had 475 ads last year. We've had a lot of surgeon ads, we've had healthy surgeon additions this year as well. So we continue to see that. It's been more of, you know, surgeons have always had the option of how to approach bunions. And so we believe that lapoplasty provides a great solution. We have a lot of clinical data. We believe more than any other lapidus type solution. And so we have a lot of confidence that our lapoplasty solution gives great results and it's elegantly designed for surgeons. We constantly and regularly hear how much they appreciate the design in the OR. We've made it faster and more effective and more efficient. However, surgeons have always had the option of whether or not they're going to approach a patient surgery with a lapidus procedure or an osteotomy. And there have been some differences between the two approaches. And so we continue to see that. And some surgeons continue to use lapoplasty, but may decide that maybe the percentage of the lapidus or the lapoplasty procedures in their overall patient base is shifting a little bit. So it's more of that. I don't wanna say that's the answer for every surgeon because every surgeon is different, but we've definitely seen a trend that MIS osteotomies are more and more of the overall procedure base.

And Mark, I think that's why we're pretty excited about this upcoming MIS osteotomy program that we're gonna be launching because now we can be the solution provider for those cases that they're opting to do MIS osteotomies on today instead of a lapoplasty potentially.

Julia, operator, are you there?

Yes, I am. I'm showing no further questions at this time. I would now like to turn it back to Julie Dewey for closing remarks.

Thank you. And thanks everybody for joining us today. We appreciate your time and interest. If you have more questions, please reach out and we'll look forward to talking to you next quarter. This concludes our call.

Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.