Treace Medical Concepts, Inc. (TMCI) Earnings Call Transcript & Summary

Well, good morning, and thanks to those on the webcast. A special thank you to Treace Medical Management. We've got John Treace, Founder, CEO, Mark Hair, CFO. Thank you, gentlemen, for joining us. Maybe just to start, you guys did just report your third quarter earnings last week. And I think one of the big questions coming out of earnings, you outperformed expectations a little bit, it feels like we're turning a corner. But as we think about 2025, and I appreciate you're not going to give guidance here. But how should we think about the sales growth trajectory given the cadence, you've got several new product launches, but also you have easy year-over-year comparables.

Maybe I'll start with that first, thanks for having us. A great conference. Always happy to be here. So as we think about this year, we've talked a the first quarter of 2024, we had some fantastic growth. We had 21% growth. And then we noticed some changes, some shifts in some of the trends for this year. And so we reguided, we level set some expectations based on the trends that we are seeing for 2024. We reported 6% growth in Q2, we did report 11% in Q3, but we believe that, although we're really pleased with that result, that it was largely driven by an easier comp. And so we guided again in Q4 to kind of that 7% to 8% range. So right now, fundamentally, nothing has really changed for the company other than we've got this great portfolio of new products coming, but we're really not going to start feeling the benefit of those new products until really Q1. And so that's just the way we're kind of thinking about that. And then even Q2, we'll really be able to see more of the benefit of these new products. It takes 3-plus months to get training and get higher adoption from our surgeon customers. And as we think about the growth rate actually Q1 of this year, as I started in my comment, was a 21% growth. So as we get into next year, it's going to be a little tougher comp. And so again, I think we want to just manage those expectations that it really might we might be to see kind of that growth until Q2 of next year because Q1 might be a little tougher with that comp. Now with that said, we know that we're going to be able to see more benefit from these new products. So we're looking forward to Q1, but I think we're going to see more of that financial increase in revenue growth really starts to come in Q2 versus Q1.

Okay. So if we think about guidance, I mean, right now, the Street is modeling high single-digit growth for 2025. And I mean you're guiding to that to sort of like high single 10-ish percent growth for the year.

Well, we've even talked -- yes, we've talked about somewhere between 8 and 10 meaning that again, if you start with Q1, it might be a little bit lower growth rate in Q1. So that could be single digits again. And then after that, then I think we can start seeing the opportunity for potential double digits post Q1.

Yes. And so -- and just thinking conceptually, I mean, the cadence of new product launches, you do have Nanoplasty launching, you're rolling out SpeedPlate. So conceptually, if you think about, again, appreciating this is not guidance, but whatever you do in '24 in theory, like with these new product launches with maybe the market, which we'll get to in a second. But it should at least stabilize if not accelerate. Is that a fair way to think?

I think that's a very fair way to say it, because like I said, Q1 is just going to be a tougher comp. But when we get to Q2, we don't have those same issues. And then now we'll have in Q2, we'll have 3, 4, 6 months of new products out there, including Nanoplasty, including some other osteotomy products that are coming out this quarter. So we're looking forward to Q2. I think it's going to be a lot better positioned for us to talk about 2025 when we get to Q2. We can see how many surgeons are adopting the new products. We'll be able to continue to see how Adductoplasty, that attachment rate to Lapiplasty, that continues to grow. That's been a great driver of revenue for us in 2024. We believe that's going to continue into next year as well.

Okay. Got it. You've also committed to EBITDA breakeven, I think, in 2025. Can you talk a little bit about the drivers of positive leverage as we head into next year?

Absolutely. So we talked about -- to back up a little bit, we talked about this year really reducing our EBITDA loss that we recorded in 2023 by half and then the other half was always come next year. So it's been a planned 2-step process. Next year, we've talked a little bit about it already because we're benefiting from some of the natural leverage. We've been spending the last several years growing this amazing sales force. And it takes a lot of investment and time as we split territories and that effectively resulted in a double payment of commissions for a period of time. And sometimes you go into areas that don't have maybe existing territories or sales reps. And so you may have to pay a little bit more until they get on their own two feet. What we're seeing now is we have more sales reps that are commissioned only. And so there aren't any of these incremental payments that we're making to them. And we're going to see more and more of that as we go into next year. And that's going to make a big difference because we're not we're not leaning in so hard and growing our direct sales channel as rapidly as we have over time. So that's going to be a very natural leverage on the P&L. Another place that we've talked about is we've historically focus a lot on our DTC efforts to build some brand recognition. Well, we're in a far different place today. I think everyone -- all the surgeons out there really know who Treace Medical is and what our product offerings are. And so we will continue to do DTC. We think it's a benefit for both educating patients as well as surgeons, but I don't think we need to continue to lean in to increase those. So those are two natural places that we're going to see leverage. We've also made some changes throughout the P&L, too. So you can see some in the G&A line that is moderating. And again, we're going to have some natural leverage there as well.

Okay. And then one more question on financials and just thinking about the potential impact from recent hurricanes. I mean IV solution shortages, feels like some hospitals are scaling back on elective procedures. Any -- what's baked into your guidance for Q4, specifically with that?

I want to try and jump in. Well, usually, anything guidance is Mark. Yes, we're a Florida-based company, we had two hurricanes come right down our pathway and a known area of the country that we have fairly significant sales penetration as well. So we did see some impact to cases, cancellations in October. A lot of those we expect are going to come back before the end of the fourth quarter. IV shortages. We know that, that impacts some accounts to and there were some canceled surgeries we expect and hope those will come back to. That said, when the volume of patients seeking elective surgery at the end of the year, particularly November, December is so high and surgeon block time is sort of pretty allocated it just stands to reason that some of those patients may not make it in the fourth quarter. They may fall over to January or February of next year. And we see that every year. We see a certain spillover effect of those patients that are really committed. They want the surgery they just can't get fit in due to block time limitation. So they end up Bunions season starts to extend into January and February of the following year.

Got it. Okay. Let's talk about the market a little bit. This year has been a unique year in the market, and it's not just you guys that called out some softness in the market. I don't know where we are. Maybe you could talk about where you think we are in the recovery here, but also like maybe opine a little bit about what happened and why there was softness in the market.

Sure. When we had our call back in May, we talked about more competitive entries into the market with copycats of Lapiplasty. That was one factor. The other was this growing interest in the patient side for minimally invasive osteotomies. And those two factors were just slightly dampening the average number of cases that our surgeons perform just by a little bit, but just enough that it changed the trajectory as we look through the rest of the year. Now that's not to say that at the same time, some of the same variables were occurring that other companies have called out, limited block times, patients concern about inflation, maybe holding back and wanting to wait later in the year until their deductibles were extended. And we see that to some degree every year. So there's always a little bit of a change in patient behavior. So I think those two things going on were what we saw. And I think we sized them right, and we don't really see any big difference to what we perceive back then and assessed through the end of the year. I think we captured the amount of competitive headwinds, the osteotomy headwind and the patient side. We didn't necessarily expect IV shortages and two hurricanes, but then again, we feel like we've got our hands around our guide pretty well there.

Okay. And then just at a high level, if you look at the market and maybe foot and ankle broadly, but specifically the bunion market. your view of the fundamentals of this market has not changed regardless of the softness that we saw earlier this year.

No, this is -- it's a tremendous market. We just find that patients based on different variables. It's a very kind of tight demographic. You're talking about the 3- to 6-year-old female being maybe 80% of the patients, both are commercially insured. So that isolated group of patients can swing a little bit differently from year to year. Last year, for instance, we saw abundant season start at the back half of September. This year, it was a little more delayed and it started a little bit in the back half of October. But as we sit here today, I can tell you, we are right in the middle of bunion season. The volume is there. and patients are coming in like they do every year in the fourth quarter to have their bunions is fixed.

Except for me, and I really need to get my bunion fixed. But anyway, just on the competitive environment point, so you did have competitive product launches over the last year. Where are you -- there's some trialing in this market? I imagine much like other markets. Where are we in the competitive environment today?

Yes. We haven't seen really any significant change versus our reguide in May. We think we assessed it about right. We're reloading our sales force with some very exciting new technologies that's going to put Treace Medical back on a very strong offense, we believe, and shore up the -- some of the areas of exposure that allowed competitors to get into our customer base. And then we also believe we can attract a lot of new customers with some of these new technologies as well. So we feel good about where we are and competition is there, but this is a really, really focused company and a company that can develop really compelling technologies that surgeons we've proven, once we get them out there, train the surgeons on them, they want to adopt and they adopt them pretty aggressively because they're very, very, very well designed, and they're supported by a company that really holds their hands in training and then support them with expertise in the OR with our direct expert sales force.

Right. Is there trialing in this market? I mean, is that part of what happened as these competitors launch products and the surgeons want to try them and then come back to Lapiplasty? Or am I overstating that impact?

No. There's a lot of noise. There's a lot of churn, and that's been going on. Now some customers most of our customers that have churned or trialed, we don't lose them. We just lose a fraction of their pieces.

Which is an important point, yes.

Yes. But when a lot of that is going on at once, it can kind of dampen the numbers a bit. So that's what we've seen. That's what we saw. And we may continue to see that to some degree, but we think with these new technologies, we're bringing forth it's going to reverse that trend.

Okay. Got it. And just looking at the Q3 outperformance, I mean, how much of that would you attribute to market recovery? So you mentioned the easier comp, so that's a good point. But market recovery versus specifically treats redoing some of that share from competitors?

Yes. Like Mark said, we don't want to be doing an end zone dance over our Q3 performance. But I will say our sales team after our reguide has become very hyper focused very focused on their customer base. They have new customer analytics that allow them to tell if somebody is changing their behavior a little bit. These are tools that have helped advance their perspective on their customers and stay more on top of them. And I think that is benefiting us a little bit. And now as we start to get these new products out into their hands, they're starting to see the cases occur around the country with these new technologies, and it's getting them pretty excited.

Okay. Okay. And we'll talk about the new technologies in a minute. I did want to talk a little bit more, sticking with the competitive line of questioning and the competitive moat that you guys have built. Maybe talk about that, how broad, how wide is that just thinking about potential future competitive launches, but ankle's always cited as one of the highest growth orthopedics market. So there's probably more to come from a competitive perspective.

Yes, great question. So we have a lot of different competitive moats. We have our clinical data sets, which differentiate Lapiplasty versus any other bunion procedure or specialty Labtest procedure in the market. We have our 65 U.S. issued patents. And we obviously announced taking action to defend our IP recently, and we are going to defend our IP. It's the right thing to do for the business and our shareholders. And third, our product technology pipeline has -- we have really doubled down on it with our R&D investment to hone in on what are all the facets of bunion and interrelated bunion procedures. And do we have a solution that's going to be best-in-class for each one of those. And then our top training events, where we go deeper and deeper with surgeons and our training events I think, than any other company into bunion surgery. And this next year, we're excited to unveil a new program, it's called Bunion Masters. And this is going to be our new educational forum, national level events where surgeons come there's going to be top level expertise, faculty and people that want to master bunion surgery, want to come to these events, to get the best training they can and be equipped with the best technologies to go implement in their practice afterwards and then have the best sales support with these highly expert direct focused sales reps. So I think those are our moats and just making sure that we've got the right offensive product weaponry to go forward and make sure that we can handle growing this company at the rate without hitting those bumps in the road wall.

Yes. Yes. And I think that's an important point. So I think it's safe to say, you guys are the only company out there solely focused on bunion surgery and you're the only company that has a sales force solely focused on bunion surgery. And I'd argue, maybe have the broadest product portfolio? Is that a fair assessment?

Not yet, but we will shortly. We think the technologies we're bringing out give us a really great position in the two main areas of bunion surgery, and we believe we will have the best most efficacious technologies, whether you're doing a lot of a surgery or you want to do an opiate.

Yes, okay. Okay. surgeon utilization had been a big piece of the story. I think still is. But I'm just curious, as we think about the growth over this year-to-date, how much of this is newer surgeons coming online just not ramping as quickly, maybe like low-hanging fruit in the first few years of launch and their higher volume. Is that something that's affecting growth right now?

Well, I think there's a couple of ways to look at it. So we have a lot of key metrics that we're driving our business with. One is how many surgeons are we adding? So we continue to add surgeons. We gave some guidance range of, say, 250 to 300 new surgeons this year. And although we didn't give specific numbers, we did comment that we're well on track there. So we continue to add surgeons, what we've seen is, to John's earlier point, that there's been a little bit of slowness this year, and the frequency in which they're using our products has declined a little bit. So we've seen that in some of the earlier surgeons we've seen even some of those that are, I'll call mid- or longer-term surgeons that have been with us for a long time. And it's just some time that frequency. So that frequency can be dependent on just the overall market if there's fewer patients that's going to impact a little bit. And then some of those surgeons where we talked about either trying to do more their cases doing a different approach altogether that could be an MIS osteotome approach, where they may have historically used Lapidus or Lapiplasty specifically. Or maybe they're just trying to look at some of these new competitive offerings. And so we've seen that overall utilization come down. The good thing is the strength of our business we continue to grow surgeons every quarter. So that we feel it's healthy. And when the economy and the overall market strengthens a little bit. Again, we're going to have a bigger customer surgeon base next year. It's the biggest it's ever been in the history of the company, and then we'll be able to pile on these new products. And so that's why we think next year is a really good combination.

Okay. And so just to sum that up, surgeon utilization increasing is still a big part of the worry. It's not -- you're not relying on adding surgeons. You are adding new surgeons, but that's not the sole growth driver from here?

Correct.

Yes. Okay. All right. Maybe let's shift gears and talk about the new products, specifically the nanoplasty, osteotomy product And maybe let's start talk about the total addressable market, how you view that market with Lapiplasty alone and how the nanoplasty product launch changes your TAM?

Sure. So still viewing that there's about 1.1 million symptomatic surgical candidates that have bunions. They need the surgery, but still only about 450,000 of them are getting surgery per year. About 30% of those patients are choosing to have a Lapidus type procedure or Lapiplasty. 70% or to have some variant of an osteotome. And within the osteotomy category, the fastest-growing segment, but it's still very small, 10% to 15% is the minimally invasive osteotomy segment. So as we look at where we're going as a business, we have over 3,000 surgeon users. If you look at on average, those 3,000 surgeon users, we're getting about 25% of their overall bunion cases with Lapiplasty. Now we've developed a breakthrough technology for minimally invasive osteotomy surgery. And a lot of those surgeons, our surgeons are dabbling with minimally invasive osteotomies and they struggle with them. And we've already trained a couple of hundred surgeons on our nanoplasty and these are doctors that have been dabbling with the minimally invasive osteotomies or they've adopted them or their surgeons that we've never done business with before because they've looked at us as a Lapidus company, and there's a pretty significant group of surgeons out there that try to avoid a Lapidus type approach at all costs. They want to use osteotomies. I can tell you the reaction to nanoplasty has been extremely powerful and compelling. And we're out there today doing cases in our limited market release. And we're seeing the X-rays seeing the results we're seeing the doctor responses, and we're really enthusiastic about this. We think this is a big moment for the company to go after the lion's share of the bunion market that we've never touched before.

Yes, yes. And can you talk a little bit about how nanoplasty is differentiated, how you solve the problem of the minimally invasive osteotomy, and why it's only been 10% to 15%, where you see that going over time with nanoplasty.

Yes, great question. So today, if you talk to. Surgeons that teach minimally invasive bunion surgery or have adopted it, they'll say it's 40 to 50 case learning curve. It's a lot of freehand eye and powered bur cutting and looking under fluoro and trying to do everything without a good line of sight of what you're doing. So the learning curve is a big rate limiter. Just like we did with Lapidus, a 3-plan Lapidus procedure before Lapiplasty. Lapidus, don't forget, was a very fussy freehand operation done by very few surgeons. The instrumentation and developing a straightforward stepwise technique is what drove Lapidus from 10% of the bunion procedures, the 30%, and that was our doing, we have designed nanoplasty with the same tenants. We're adding the third plant of correction that we know can make an osteotomy more enduring or more successful. And that's what Treace Medical did to Lapidus as well. And then we're doing what we did with Lapiplasty before, elegantly designed really straightforward instrumentation that makes the surgeons super confident that they can go into one lab training and be in a case the next day with their rep and perform the procedure with confidence and with accuracy and implement that into their practice quickly. And that's exactly what we're seeing is we've trained doctors on this, and they've gone out and done their first cases. So now it's just a matter of building our product supply, getting more surgeons trained and getting the product down further supply.

Okay. And just following up on the point that you made about surgeons that didn't want to touch Lapidus type procedures before and it sounds like you're getting traction there. As you get traction with the nanoplasty at that surgeon, are you actually seeing them change their views on Lapiplasty maybe? Or is that not the right way to think about this?

And great question because when those surgeons that hadn't done business with treats before, they get excited about nanoplasty. When we train them, we also expose them to microlapiplasty. We expose them to Adductoplasty. We expose them to our SpeedPlate technology. And they start to realize Treace Medical has a lot of really incredible things and they go back. Now they've been waiting to do a nanoplasty case, but we've had several doctors do Lapiplasty, use our SpeedPlates, so we think there's a real 1 plus 1 equals 3 effect we could get here as we go out and engage new customers that have never been with us before and get that pull-through effect both on Lapiplasty and our other technologies.

And we're still very early, just to be clear because nanoplasty just in limited release. So we're talking small numbers from a surgeon perspective again, why 2025 is set up for success.

Right. Right.

So the other question I've been getting is on the pricing side of things. So revenue per procedure. Nanoplasty is going to, in theory, bring that number. How do we think about that number going forward with broadening the product portfolio.

That's another great question. And I think there is a concern out there, maybe even a misperception that there's a lower-priced product that we're going to push really hard and it's going to bring down our average revenue per case. We don't see this being a big cannibalizer of Lapiplasty. All these doctors have an algorithm in their head as to where their limit is on applying a Lapiplasty or Lapidus type of approach and some of it's very high as a percentage of their patients. Some it's very low, but they're all in that mix of 3,000 surgeons. And that's why if you blend them all together, we only have 25% of the bunion cases. That being said, we kind of have two things going on. We have Lapiplasty cases that they're a higher-value procedure. There's a higher attachment rate of a Adductoplasty occurring, and that doubles the average price of Lapiplasty case. On top of that, we're seeing SpeedPlate use more in the back of the foot as add-ons to the midfoot Adductoplasty cases. So the average revenue per case, we're getting into more complex surgeries, bigger dollar surgeries, higher number of individual procedure surgeries on this side. Now we're bringing out nanoplasty. Nanoplasty actually has a reimbursement level the way the surgeons do minimally invasive. Osteotomies that's very similar to a stand-alone Lapidus or Lapiplasty. So it's not bad reimbursement. And this is a premium price technology. And the average cases we've done so far have built out at a very nice price point. So -- and we also have those other complementary offerings to do the hammer toes and fix the adjacent fusions that need to be done in the foot. So we believe that the nanoplasty and minimally invasive bunding cases are going to continue to carry a pretty nice blended ASP as they are. And then you have this growing impact of these more complex surgeries on the other hand, kind of balancing everything out.

And well, so to be clear, this is probably a dumb question, I apologize. But with nanoplasty, do you see the ancillary the Adductoplasty with the nanoplasty to? Or is that really just what the Lapiplasty add-on?

Those tend -- the bigger Adductoplasty type of add-ons will tend to probably be more in line with Lapiplasty because you're kind of commonly treating all the joints with a joint fusion at the base of the joints. With an osteotomy, it's a little different approach. But we do have those other complementary procedures, and we're seeing them be used in pretty good frequency in these early nanoplasty cases.

Okay. Got it. And going back to the TAM conversation, and you've talked in the past about, I think -- I hope I'm not misquoting but I think right now, you're only addressing 15% of or something like that. How do we think about where to from here. So you guys are going to launch are launching your osteotome product. What's next for Treace beyond bunions?

Yes. Great question. We're kind of doing a connect the dots method to our product development and then identifying other complementary procedure areas that tie off of where we last left off, like the union led us to Adductoplasty. Adductoplasty got us in the midfoot. Speed play technology is now getting us in the bones further back in the foot. There are other procedures that we have identified that are very high volume that tie into the bunion or the midfoot. And we've already lined up new product launches. We haven't spoken of them yet, but there will be additional things coming out in the first half of 2025 that will continue to identify and target some pretty large opportunity areas for us. So it's going to expand -- we say we have a $5 billion plus TAM on the union space with our current technologies. Nanoplasty doesn't really impact that much. We haven't changed our TAM because our average revenue per case is much higher than we establish that TAM. So you could say our TAM is much larger than $5 billion right now. Adductoplasty alone is a $500 million incremental TAM add to us and another opportunity we're excited about.

If you think about the parts of the foot, what would you say like your technology that you have in hand today addresses like what percentage of food procedures?

That's a great question. I can tell you the -- there's kind of a saying, but I think the math holds that you can reach about 60% of the total overall reconstructive foot and ankle market. anchoring from the bunion because attributable and identified with the bunion are so many different comorbidities and overlapping pathologies. And that's a great place to work from. And that's why we built the business the way we did. So let's really go establish ourselves as a leader in the bunion space. with a direct sales force experts and then branch from there and start to address these other opportunities in the foot angle and then broaden our footprint in the foot and ankle market over time, but do it in a progressive way that doesn't scatter our sales force into trying to call on a lot of different procedures that aren't cohesively kind of tied together with a common theme.

How important is it to have that broad product offering when you're going to the surgeon? And I ask that question because you do have large competitors, but they don't necessarily have the breadth of product offerings focused on the foot, the way you guys do.

Yes. I think having a comprehensive bunion portfolio is pretty strong, and that's our first step is getting that locked down. And that puts us in a great position. I mean, doctors do like to deal with experts in the space and bunions are bread and butter procedure for the vast majority of our certain customers. And they -- those patients create so many referrals for them because 65 million Americans are affected by a bunion deformity to some degree. So everybody knows someone with one. And when they get... A surgeon treating one, that surgeon -- that patient goes out and tell other people about Dr. Smith and the great bunion procedure. They may have a different problem in their foot, but they'll go see Dr. Smith now because someone spoke nicely with them, by the way, they fixed their bunion in a very sophisticated way.

If you think about penetration from a surgeon perspective, you main you have over 3,000 users. And to be clear, these are predominantly podiatrist, right? Or are they also orthopedic surgeons?

It's about 70% podiatrists and 30% orthopedic surgeon.

If you were to sort of try to assess where you are from a penetration into surgeon users perspective, where would you say you are? And what's the barrier to a surgeon adopting your technology?

So we assess -- estimate there are about 10,000 surgeons in the U.S. that perform bunion surgery, some -- a lot of bunions, some less. The mix of those is about 2/3 podiatrists in the third orthopedic foot ankle specialists. So we've got about a little over 3,000 certain customers. So we're about 30-plus percent penetrated. We think that can continue to grow over time. It's hard to say where the MAX point is. We're pleased with our progress. And I think the rate limiter is to bring on new surgeons are bringing these new technologies for that appeal to audiences that we haven't had an offering that appealed to you yet. Again, these minimally invasive osteotomy products. I talk to play, we have mini Adductoplasty coming out for surgeons that are more small incision minded that want to tackle that difficult midfoot deformity. Now they may look at Treace Medical. We have another really exciting platform that will be ramping towards full national supply by the first half of next year, and that's our Redpoint intelliGuide technology. Taking a patient's CT scan and software engineers correcting that patient's deformity with feedback from the doctor and handing that doctor a cutting god to make their corrective bone cuts that's specific to that patient. And that's the first and only from Treace Medical that as it gets out there more and more, there's an incredible amount of certain interest in this technology.

Great. Well, we are a little bit over time. So thank you, guys, for joining us, and have a great day.

Thank you, Danielle.

Thanks for having us.