Good morning, everybody. Thanks so much for joining us. My name is Matt O'Brien. I'm one of the med tech analysts here at Piper Sandler. Really excited to have the OrthoPediatrics team here with us today. From the company, we have Fred, who's the COO and the CFO, and then Joe, who heads up Trauma and Deformity for the company. So, gents, thanks so much for coming all the way out.
Thanks for having us. Appreciate it.
So Joe, maybe let's start with you a little bit. This T&D business that you run, it never gets the love, I think it should. But just maybe talk a little bit about two products that are really driving a lot of the growth that you're seeing there. What's really the biggest at OP and T&D that's doing well? And then how are they differentiated for docs and patients in a way that somebody as simple as I can understand?
Yeah, sure. So maybe it doesn't get the love, but I guess we're OK with that because we continue to chip away at account conversions, so trying to increase our share across the U.S. and globally. And we have such an innovative pipeline, a robust pipeline. I've never been in a business that had so many future products that can be developed that'll help change care for kids. So it's exciting on that front. Certainly, the margins are healthy in that business. So as we keep clipping away at what we need to do, it's good for the company all around. The two biggest drivers of the T&D business, without a doubt, are the PNP, the Pediatric Nailing Platform, the Femur, and then the Pediatric Nailing Platform, Tibia. Combined, that's the largest franchise within the Trauma and Deformity business. The tibia franchise got off the ground late last year.
We were able to launch 10 different sets to go out into the marketplace. And we doubled where we needed to be and basically half the time with those limited launch sets. So that was the best indicator we had as a company that it was well received by our surgeon customers. It was extremely well received in the marketplace with our field sales representation. We get excited for that as we go forward because we launched 25 additional sets towards the end of the year. And then we have 50 5.0 sets coming for 2025. So when you think about 2025 growth, that is certainly a key driver. We continue to take share with our PNP F emur system, which is about five years into the marketplace. We estimate that we have probably about 30% share in the femur business. So there's still quite a bit of runway to go.
A little bit different than Tibia because Femur has already been accepted as a gold standard for how you treat kids with intramedullary nails. On the Tibia side, it's a little bit newer of an indication for pediatrics to put nails into children for tibias. And so as it's being adopted and as studies continue to be released on the efficacy of it, we see that growing tremendously down the road here.
OK. And 70% still market share available on the femur side. That's just adult products getting cut down still to this day to fit those patients. Is that right?
I don't think they get cut down as much as they did in the past. But there certainly are adult systems that are still hanging on the shelves at some of our children's hospitals. And we're working our way through to convert those, getting those sets out, those systems out to put the femur systems on.
OK. And how many more sets do you need on the femur side to then really convert a majority of the market?
Over the span of the next five years, we'll probably double the amount of sets. So I'd say there'll be another 50 to 60 sets coming out. I think we have about 100 out there today. So maybe 150 total to get us closer to the share.
Got it. And maybe just for the audience, how expensive are these sets? Because I think everybody's like, 50 sets. Well, all right, go ahead and get it done. I had to stop myself there from saying get it done. But get it done.
You're done.
Why is it so difficult to get those sets out?
I wouldn't say difficult. I'd say that we've had a couple iterations of that system. So from the very initial launch five years ago, we've made advancements, adjustments to it. And so had you launched 150 sets immediately, now you're talking about having to replace those sets. So we're systematically bringing this into the marketplace. I think for me, the most exciting part is adding sterile nails, implants, to the system for 2025. So when you think about the total cost of the system with implants, we'll be able to launch more sets with implants being separate of the system. So you'll have instrument sets. And then you'll have less implant sets because those can be more mobile throughout a regional area. And so the cost continues to come down.
I think between all of our systems, the dollar sale per dollar of inventory for the PNP F emur is the second or third highest in the entire Trauma and Deformity brand.
Got it. And I'm a little surprised to hear that the tibial side is doing so well, just given that it's something that clinicians, there's not a lot of, I guess, evidence on that. Why is it done so well? And then is there any kind of halo effect you have now with having Tibia plus Femur?
There's a halo effect absolutely running into tibia, meaning that surgeons that use the PNP F emur have been used to the reason why it's a pediatric nailing platform is that all the instruments, all of the implants, the system design, how it looks, how the scrub technologist interacts with it, it is almost duplicated in the Tibia. So a surgeon who's comfortable with Femur can easily transition to the Tibia. Staff easily transition. I think serendipitously, we launched the system as two or three clinical papers were also released at the same time, explaining that tibia nailing with certain indications in children is the best course of treatment. So we were timed very well on the launch with those papers coming out. There'll be more studies that come out to prove it. There's also other procedures in the sports medicine space that have a similar surgical technique.
And so basically, surgeons that look at this system know that you're not doing anything different that you wouldn't be doing in a different application. So you're not creating any more harm to the child. And now that they have these going in their own practices, they're starting to get volumes of outcomes with their own patients that's just sending the signal that this is the right step to go.
Got it. OK. Are those two products really the big drivers for 2025 and 2026 in T&D? Or are there more things coming that we should be thinking about?
I'd say Tibia, without a doubt, is a key driver for 2025. We're also very excited that we'll have our first installment of the Pediatric Plating Platform. So on the plates and screws side of the business, we're going to bring the Hip system to market sometime in the first half of 2025. So there'll be a small impact, a light impact in 2025. But in 2026, once we have a scalable amount of sets into the marketplace, we'd expect that to be a big driver.
OK. Can we talk about plating for a second? There's a big competitor of yours in Kalamazoo that was just been crushing it on the nailing side. They're coming out with a plating system now in trauma. And they're really excited about it. Is this plating opportunity for kids significant or maybe underappreciated by investors?
Maybe I shouldn't answer that, right? It is. It is underappreciated. I would say that the pediatric side of plating, the challenge is that you have to have 20 or so different systems to support that patient population, so just coming out with one system that might hit one pediatric indication isn't the key to the entire franchise. It's having all of those systems in order to help a surgeon choose between A, B, and C as any case pops up during the day. S ome of it's with trauma, so for trauma, you can't plan for that procedure as it happens acutely, and so the surgeons sometimes in that moment have to decide, well, what can I use, and so immediately they think OrthoPediatrics because they know we've got the broadest portfolio in the plates and screws space.
Almost half of T&D's revenue, over half, is in the plates and screws business.
Got it. OK. All right. Appreciate that. I'm going to bounce around a little bit here. Maybe we'll head back to the Spine business for a second. I don't know if you want to talk about this. But the Scoli business was really strong in Q3. Obviously, it's a strong seasonal quarter. What drove that? And what do the 7D sales/placements mean for 2025 for that business?
Yeah, absolutely. The third quarter for Scoli was very, very strong, greater than 50% year-over-year growth. And I think the nice thing about it, it's hitting on all cylinders. It's not just one thing. So domestically, continued to take share in that business with the RESPONSE Correction system, as well as ApiFix. And to your point, 7D Surgical System is an additional adder. So we had unit sales, 7D unit sales in the third quarter, which helped the quarter, but more importantly, is a big growth driver for us in 2025 and 2026. One of those units in particular was at a large location that had done effectively zero spine in the past with us. And so that technology, 7D technology, which is navigation with zero radiation in the OR, which is perfect for pediatrics, obviously, is really, really well received by our surgeon customers. Everybody who sees it loves the device.
By placing that unit in there, we'll be converting the Scoliosis business to OP. We'll continue to drive growth for us starting here in the second half of this year, but more importantly, into 2025. The other growth driver in the third quarter for that business was OUS, which was up dramatically. That is selling sets to new distributors, primarily in Latin America. We're introducing more sets into that market, which just like we were talking with the PNP sets, when you get more sets in there, drives more replenishment inventory. Overall, just hitting across all aspects, taking more share. It will continue to drive nice growth for us in the future.
Got it. And you have a new Scoli system coming. I mean, the thing that's amazing is this performance is coming with RESPONSE. It's been around for a while.
It has.
Which is great. But you've got the new system coming. What should we expect in terms of timing there? And I know you don't want to give away too much to your competitors. But any kind of sense for what from a feature perspective could be unique there?
Yeah, the RESPONSE Scoliosis Correction System is about 10 years old. So it's getting up there. We have started working a couple of years ago on the next gen, next version of that. That system should be launched in the second half of 2025. We don't expect a huge impact from it, as it'll probably be late in the year. But it'll be a big growth driver for us in 2026. It's a complete refresh of the system. So taking all of the learnings that we have accumulated over the last 10 years, incorporating that both on the implant side as well as on the instrumentation side of that business. And it'll also come with some technology, let's just say, on maybe presurgical planning, integration into navigation, some technology around it separate from the implant and the instruments refresh on the system as well.
Got it. OK. All right. Sounds compelling. So you know the affinity I have for ApiFix. You guys do too. Forgive this question if it's too blunt. Is there something with the anatomy of these patients that will not support a system like this? Because it's been a while now. We've been waiting for ApiFix. I know you're taking your time. It seems like it works pretty well. But we're not seeing that dramatic growth like I thought we would. So is there something about the anatomy that's just too difficult to treat these patients without a very rigid instrument in their back to ensure that they don't get any kind of fracture or any other challenges?
We're three years into ApiFix, which is a non-fusion device to correct scoliosis here in the United States. And we've learned a lot, right? We have a registry now completed. And we have all of that data. What we did not have, which we had in PNP T ibia, Joe just mentioned, is any type of white papers or any type of documentation on it. So the last couple of years has really been collecting that data, analyzing that data. In the third quarter, JPO, the Journal of Pediatric Orthopaedics, we were on the front cover of that. There was a study out of Mayo that was specific to ApiFix, highlighting the benefits of it. And we see tremendous results and benefits from ApiFix. But it's, we think, on a narrower or maybe a little bit of the middle of the curve, if you will, on when to use it.
So the patient needs to be flexible. If they're not flexible, that can cause some issues. And they have to have the right curve. And if it's used in that middle of the curve area, the bell curve, it's very, very effective. And so what we're seeing is more and more surgeon adoptions, but probably a thinner patient population that can use it. So it's getting the product into the hands of more and more surgeons. And it's not something that's going to be used all the time. It's a tool they can use in the continuum of care with their patients. So Bracing, which we now have with Boston, ApiFix, kind of in the middle. And then if a patient has already passed that point, then it's RESPONSE on the Fusion side.
Got it. OK. So I had written a note a couple of years ago saying I thought this could be a $100 million product. That's clearly not the case. How big do you think ApiFix could be eventually?
We think it's part of the continuum of care. So we don't think it's going to completely replace Fusion, which maybe we thought initially before we had the experience we have now. It will continue to grow over time and I think see more and more adoption across the world. We're selling it outside of the U.S. as well. It'll be a growth driver for us. But it's probably never going to be a $100 million product line, would be our assessment at this point.
Got it. OK. Understood. What about the rest of the early onset scoliosis portfolio? Where are we at with some of the growing rods? And when can we see those and they start to impact the business?
Yeah. So EOS, early onset, is an area that we hadn't played in in the past. It's very complicated. It's probably 15% of the overall market. It's very severe curves and young patients that have other health issues as well. And so our first launch into that is rib and pelvic. So we're now selling rib and pelvic hooks and screws for that EOS indication. The second, which we're very excited about, is VerteGlide, which is a semi-fixed. So it's fixed at the top and the bottom, but it slides in the middle. And then the product coming after that is called eLLi, which is a mechanical growing rod. So VerteGlide and eLLi are in process right now. The products are almost done. And we're working with the FDA to get those approved. I think you heard Dave talk about a bit of a delay with the FDA.
It's a little bit of uncertainty right now with where that stands. Initially, we thought those products would be approved through a 510(k) clearance. That seems to not be the case with the FDA, according to some feedback they've given us. We're working directly with them to understand, define what is the path and what is the timing of those products. With that being said, we will probably have some sales of VerteGlide here in 2025 outside of the U.S. and a couple other facilities that are willing to use the device, allow us to collect some clinical data that we can then use back with the FDA. Unfortunately, we can't put a date on when it's going to be approved and launched. We're confident in 2026, 2027, those two products will be nice growth drivers for the business for sure.
OK. So maybe let's flip over to Specialty Bracing. Joe, is that in your world?
It is. Yep.
OK. All right. Talk about the Florida expansion that you're doing there. How many facilities? And when do you think they're really going to be ready to sell the full OP portfolio?
Yeah, the Florida facility just outside of Fort Lauderdale, amazing group, amazing team that we're bringing on board, some of the best clinicians we have now that are part of the team. I would look at that as a target market area. And when we get into some of these areas, especially as we go into new states, we have to enter the state two ways. One is to either start it up on our own, which we would call greenfield. And the other is to acquire to get into the space. This was clearly a strategic acquisition to get us into Florida. We've got four different target market areas that we want to get to over the next three years, Miami being probably the highest priority.
And so if you think about the Miami, Fort Lauderdale, West Palm Beach, that whole section is what we're really looking to get after in 2025.
Got it. How many facilities in total do you think you'll add next year for all of Specialty Bracing?
We estimate that there's 80 target markets. Instead of talking about facilities specifically, there's 80 target markets. You can picture all those target markets. There's typically one of our 300 focused children's hospitals in each one of those markets. We defined 80 of those that we want to get to over the next 10 years. For next year, we are going to get into four target markets, which will increase. Right now, we're in nine target markets. Picture those as greater metropolitan areas. We want to add four of those. That might be with one clinic. That might be with two clinics. It could be with three. I think the Fort Lauderdale is a great example of now we've got a home base there. We've got great clinicians.
Getting a greenfield set up in Miami becomes a very not easy, but a more simplified process. That would be that then would tell us that we're going to probably have about three clinics in the greater Miami, Fort Lauderdale area. I would say just for investors to think about the population density in greater population area is how the size of these, right? We said they'll be somewhere between $1 million to $3 million worth of revenue per clinic. Depending on the size of the city, it could be higher and it could be lower. We still estimate that all of these clinics, if we get to three, we'll have that revenue come through.
Got it. OK. What are you seeing early days in terms of the centers that you brought on board with the Boston Orthotics & Prosthetics deal? Are they tracking from a revenue perspective like you expected? Are they slower because of the transition? Are you starting to see any kind of revenue synergies?
Yeah. One of the most important things that we wanted to make sure we got done after this acquisition was to ensure that the quality of care, that we don't skip a beat when it comes to capacity to keep up with volumes. We were nervous that once we acquired Boston O&P, that surgeon customers might immediately start referring out there. That certainly did happen. We were very thankful that before the acquisition, the Boston O&P organization upgraded their home office and moved it from an area in Boston to Stoughton, Massachusetts. So they were able to adjust into the capacity quite quickly. And we immediately saw an uptick, especially in the places that had a lower share. So you think about the Boston, the clinics that are in and around the Boston area, we already had what we'd say is about 80% share of that market.
We didn't see a big uptick from that, but in the Philadelphia area and some of these outlier areas, we saw immediate uptick from a referral basis into these clinics almost instantaneously after the acquisition, so I think we're just proud of the teams that have been able to keep up with some of that volume that's come through those clinics.
Got it. What have you learned? What else have you learned from that transition? I know you're getting some of the benefits. Anything on the challenging side that you're working your way through kind of early days?
What we learned was, so as you know, the three big strategies for OPSB were clinic expansion, NPD, and scaling our sales force. What we learned is that the sales force side of this, the OPSB specific sales force, is the key ingredient to ensuring that referrals happen. So if you think about that, as we meet with physicians, every physician says, "This sounds great. We should do this. I want to refer more out". I wish it ended there and that business just came in. But then patients come in. And there's a whole series of staff between nursing staff, front desk staff with the physicians that once a patient is seen and they get a prescription, they get guidance from a lot more people than maybe we estimated to start.
So, our sales force, as we scale that, that to me is the key ingredient that someone has made sure that entire pathway, when a parent has the choice to go to an O&P clinic, that they know where our clinics are and that they get referred to those specifically.
Got it. And I know it's early, Joe, but are we seeing any of the situations where you're getting some of the previous Boston O&P clinics from $1 million and they're on a trajectory for $2 million or even better than that?
The current ones around Boston, I think, are all holding steady. I think there's, of the three other target markets, we're seeing that revenue grow much faster than we anticipated.
Interesting. OK. Appreciate that. And then, Fred, I have a couple of financial questions for you before we finish up here. But the one thing that's interesting to me, I'm listening to you guys talk about all the momentum on the top line. Profitability is getting much better. But the stock keeps, is certainly volatile. Not sure if that's something that you're aware of. There's something specific that's going on there that maybe you'd like to communicate for us here today.
Yeah, absolutely. So a little frustrating third quarter, beat and raise again, as we've continued to do. And the stock obviously did not respond to that. What we found out since then is that we have a top three shareholder, if you will, that's selling stock, selling their stock. But more importantly, I think, is that they're not just selling our stock. It's not because of our stock. They're selling their entire fund. So basically, everything in their small cap fund looks to have been liquidated and continuing to be liquidated. And that, with our small liquidity that we have every day on our share, is continuing to depress the stock price. So nothing to do with the company, nothing to do with the performance, nothing to do with the execution. It's purely a decision that they've made that they seem to be liquidating that fund.
And it's dragging down the stock price big time. And it's frustrating because the company continues to execute and perform. And the stock price, obviously, is not following that along.
Yeah, that is frustrating. Certainly sounds like an opportunity for some out there. But another question for you, Fred. So you've talked about getting 13% to 14% EBITDA margins by 2027.
Yep.
You've been stepping up EBITDA by about $5 million annually the past couple of years. And so to get you to that range that you provided at the analyst day, that would imply an improvement of $12 million to $14 million per year the next couple of years. So how do you step up the improvement in profitability versus what you've been doing?
Yeah, we're very excited about the continued growth on the top line, balancing that with improved profitability and getting the cash flow break even here in 2026. $5 million of adjusted EBITDA last year, $8 million to $9 million this year. To your point, stepping up over the next couple of years, it's really increasing the leverage on the G&A side of the business. Overall, we continue to forecast 74%-75% gross margin for the business, which is where we have been for the last several years. A little bit of leverage on the sales side. As Joe mentioned, we are adding a few salespeople on the OPSB side, which will drive revenue growth. But prior to us adding those folks, there was no sales force on the Boston business.
And so we're getting nice leverage as that revenue continues to grow with a much lower sales and marketing cost than our other business. And then the other leverage is coming through the G&A side. So the cash portion of G&A, while it will grow year after year, it's going to grow at a much slower pace than the revenue growth, which gives us the leverage we need over the next three years to achieve that level.
Got it. OK, perfect. Well, I've taken us over. So I'll have to go ahead and wrap up there. Gents, thanks so much for all the feedback. Appreciate it.
Thanks for having us.
Thank you.