This is Rick Wise, welcoming OrthoPediatrics, and the CEO is here with his OrthoPediatric socks. And he said, "Free socks for all.
Absolutely.
Just give him your card afterwards.
We'll send you the bill later.
Exactly. So thank you, Dave Bailey, to my left, President and Chief Executive Officer. And on the end there, Fred Hite, Chief Financial Officer and Chief Operating Officer. Thank you both, as usual, for joining us. I think this is your fifth? Who knows, something like that. It's great to see you here again.
This is your first, though, right?
You know, every time is my first. A couple of things. Just to start with, we've had a lot of conversations lately about the, to me, inexplicable weakness in OrthoPediatrics stock in recent weeks after what I thought was a good quarter. And I said to Fred, when I called him for the third time in one day, using language which I will not repeat, "But what the heck's going on?" was the thrust of it. And I kept looking at every dark possibility. But it turns out to be a simple explanation, having nothing to do with you.
Yeah, I think, obviously, the stock has performed in the exact opposite way we would have expected after another really strong quarter. I think early on we weren't clear exactly what was going on. I talked to a number of investors, and I think it's been brought to our attention. You just look at the top of the cap table at this stage that there's a particular fund that's liquidating their position, not just in OP, but across their entire fund. I think that's what we've seen quarter to quarter for the last few quarters. And I guess, obviously, we can't look into what's happened so far in Q3, but it doesn't take too much digging to see and too much speculation to see that we're kind of swept up in maybe what's more of a technical trade that's trading inconsistent with the way the company's performed.
So I think that's the best explanation we have. I'm not sure why we would see such a down draft about a beat and raise where essentially every aspect of our business has performed not just the way we expected it, but maybe a little better than we expected it. And to see that reaction was pretty shocking. But I think we got a pretty rational explanation as to what's going on at this time.
I'm glad to hear that. So let's dive right into the business with some of the key products. Yes, Scoliosis had an excellent third quarter. International Scoli sales grew over 100% year over year. And you highlighted, Dave, that these robust Scoliosis scheduling trends after a period of time where it was a little more uneven appear to be continuing. So back on track on the Scoli front, it seems. Is that the right way to describe it? Is that the way you're seeing it?
Yeah, I think throughout pandemic, post-pandemic, RSV, all of that, I think the Scoliosis business probably was most affected by the scheduling conflicts. These are longer procedures. They take longer to perform. They're very exacting with a lot more hands in the room. And so it's really nice to see after coming through a summer where the scheduling looked robust, now really looking into the fall and pointing towards winter where scheduling looks very, very normal, like normal pre-COVID, which is the first time we've seen this in a long time. And it's really great to see overall.
Yeah, and the Q3 Scoli rebound, you're seeing it. I mean, are we half through? Yeah, I guess it might be halfway through the Q4 , steady on track?
Yeah, I think we pointed out in the call that while we saw just a touch of impact by hurricanes at the end of September, 1st of October, we grew through it, and the scheduling in October was extremely robust and just kind of a continued movement from the summer, and a lot of that has been, you know, we took share throughout the summer. We've taken share throughout the year. Now with people's volume back to normal, we're benefiting from the share that we've taken and maybe probably didn't get credit for as much of those new customers when they weren't doing as much volume. Now we're seeing that come through.
And just we'll talk about 2025 in a minute when Fred is ready. But any reason to think that the setup for 2025 would not be perhaps the best we've seen in some time based on these trends? Is that likely to continue into next year?
Yeah, I think if you just look at 7D placements, for example, where oftentimes we can correlate account conversions with 7D placements. We're starting to see here in the back part of 2024, the 7D placements kick in that we did six months before and seeing account conversion and surge in conversion. We see this in Q3. We're seeing this certainly in positive impact in Q4. And so as we place more 7D units, as we drive more customers across the entire portfolio, we're seeing the impact of the EOS product, the RESPONSE-driven pelvic, which is exposing us to certain accounts that we didn't have high share or any share on the scoli side. I mean, all those things I think are very positive for us.
And then as we look into 2025, we have the impact of certain new products, no question, particularly the next generation of our RESPONSE system that we expect to launch in the second half of next year. And so we're very bullish as to how we think this can continue. And I would also say that just as we think about the halo effect of our OPSB franchise, I mean, essentially a third of that business is scoliosis, right? And so in places where we didn't have any, maybe we didn't have implant volume. At a place like Boston Children's, for example, we didn't have implant volume. We have very, very high scoliosis volume because of all the bracing. And so I think the halo that that provides around the customer and around our accounts is certainly helping to drive market share. And I would expect that to continue.
And let's talk about 7D. Not everybody's going to know every product the way you do, obviously. What is 7D? Why is it so important? Why does it enable you to open up accounts? And just talk about how many accounts do you have now? And so there is that pull-through for Scoli and other parts of OrthoPediatrics.
Yeah, I'll talk about the product, and maybe Fred, you talk about the math here, but the product is an intraoperative navigation solution, so it allows surgeons to safely place pedicle screws. You can imagine in pediatric patients, you have pedicle screws that are placed mostly millimeters from the spinal cord. So the big concern is that a misplaced screw has obviously a dramatically detrimental impact on patient care, and so there's historically been a real challenge with how do you take these patients and use some kind of navigation when those navigation solutions have been heavy radiation-based. There's a correlation, obviously, with heavy use in pediatric patients with radiation to potential long-term cancer diagnosis, and so this solution ultimately allows patients to do navigation with very, very, very limited patient exposure to radiation. In fact, intraoperatively, surgeons don't have to wear lead because we're not even taking two-dimensional imaging.
And so it is really transformational in the pediatric patient population. And it's taken us some time. It's a capital sale or even a capital deployment. And so we're learning. We've never had those kinds of sales before. We got a big funnel. And I think there's about 20 or so units that exist out in the market right now inside children's hospitals. And we're seeing the benefit of that.
And before I get into the math, but will every center, I mean, how many in the US? 500-600?
About 300 children's hospitals.
Okay. Is there going to be one at every center in an ideal world or potentially?
I mean, that would be great, but I would think that the centers are starting to move to some form of navigation in pediatric spine surgery, and I would say that I would have told you five years ago that the use of navigation was growing, but still was a minority, probably a small minority. Now I would say it's a large minority. Probably eventually most children's hospitals are going to navigate most spines, but I think the big hurdle there was if you have to have a high degree of radiation to get the imaging necessary to navigate, it makes it very difficult. Now with the 7D technology, it's allowing surgeons to do more and more navigation more comfortably and safely, and so I would say that whether it's the 7D technology or whatever type of navigation, we are definitely seeing navigation become ubiquitous in children's hospitals.
The math part of the question, Fred?
Yeah, first of all, the thing I'd point out is some of these larger hospitals are going to need more than just one unit. And we've already seen that where there is a unit either consigned and/or sold, that they're already requesting a second unit. And so not all 300, but some of the top ones will need more than one unit. The system itself sells for around $600,000 plus or minus. The model that we're using is consigning this unit with a three to five-year contract for share gains at that hospital. Or we can sell it. And that purchase or that sale of that unit can also come with a volume rebate to also ensure market shifts happen as well. And so the majority of them have been on the consigned side. We have sold some of them.
We sold more than one here in the Q3 , which did have an impact on the margins, obviously, because these are distributed products, and so it's a capital sale that has lower margins overall, but it then brings with it increased market share, increased implants for three to five years into the future.
I just want to follow up on a couple of things. I'm jumping ahead myself, but I think that this whole story, the recovery in Scoli, the continuing flow of innovation in the Scoli side. I haven't thought enough about the OPSB connection. Talk about that business a little bit. We'll talk in a high level, but just as it relates to Scoli and how this is sort of the essence of the kid story, really, the portfolio, the one-stop shopping, and how it maybe is how it's implementing in the centers that are adopting 7D and your programs.
Yeah, I think if you think about this the way our customer thinks about this, they don't see a product. They see a disease state, right? And they're trying to take care of scoliosis as a disease state. They see that patient from when that scoliotic curve may be 15 degrees, and they're working as hard as they possibly can to avoid ever having to take your kid in for a three-hour to five-hour surgery. That's what we would all want for our own children. And so from what we have tried to do all along and starting the business is to say, we're not just here at the end of care, right? We're not just here to fuse a kid's spine. We recognize our customer cares about the entire continuum of care, and so should we.
And so if you look at the way that we've positioned the business, we can start helping take care of that patient in the earliest days, trying to brace this patient, hopefully avoiding surgery. If that patient then moves to needing potentially a non-fusion technology, we've got ApiFix, and we can bridge and hopefully again through some type of surgical intervention, but a smaller surgical intervention, avoid a lifetime of a child becoming fused. And in the instance that that child needs to become fused, then we have the RESPONSE system with 7D navigation to ensure that we can safely take care of that patient. And we're on that journey with the surgeon and with that patient the entire way. We are the only company in the orthopedic marketplace that is doing that. And I think the surgeon recognizes that.
I mean, Fred and I have always said that of all the transactions we've done, the acquisition of Boston came with the most fanfare from our customer. It was a clear recognition that you guys care about the things that we care about and that you are a true partner in trying to take care of these patients alongside us, not just sell us more pedicle screws. And I think that that is, it's hard to quantify that halo effect, but I think you're seeing it in the results. And I think we're going to see that in the results for the next several years. I think it's important to remember that our surgeon, the pediatric surgeon, 80% of their time is spent outside of the OR room. And so historically, and today when we sell them an implant, it's when they're in the OR room, 20% of the time.
80% of the time they're in clinic, seeing patients, following up with. And so we're now able to help them with services, with products on that 80% of the time instead of just the 20% of their time.
One of the things you said on the Q3 call, Dave, was you talked about just among other things, many other things, continuing share gains. And I just was reflecting on it as I was reflecting on getting ready for this today. And I thought it's sort of a funny thing because I don't really feel like you have any competitors particularly. But what's that mean? Just in a broad picture sense, how much is share gain, as you're about to define it, driving growth? Help us put that in context a little bit more.
Yeah, I mean, I think our entire growth story is about taking more share from essentially incumbent providers of small adult implants. And so we were talking to an investor earlier, and it wouldn't be uncommon, for example, for the trauma, limb deformity side of our business, for us to walk into a children's hospital, let's say five years ago, where surgeons decide they want to use our products, and there would be $2 million worth of inventory that sets from a series of competitors, maybe J&J, Synthes, Smith & Nephew, where these products have been sitting on the shelf, either purchased or consigned, and they've been there for, in some cases, 20 years. So it's what the surgeon has been using. I mean, it's a workflow matter, right? And then we come in with our cannulated screws. We love you guys.
We want to use your product. It's a process beyond having the surgeon just say, "I love you guys. I want to use your product. This is better," is displacing the competitor and placing that asset on the shelf. And that's why we talk a lot about when we place $20 million worth of inventory, that's what we're doing. We're displacing a competitor's product, making it available to the customer. And it doesn't instantly, the minute we deploy that, it's not maximum exposure in terms of its total use case. But fast forward 18 months when that thing is generating a dollar to $2 of sales to inventory, that's a really great investment for us. And so that's how we measure this share gain position is when we're literally taking product off shelf, replacing it with purpose-built product for kids. And we see this every quarter.
Lastly, I would say on the Scoli side, we do have competitors, right? I mean, Medtronic's been in this market forever. DePuy's been in the market forever. I mean, we're measuring that in terms of what are the active number of users of our products totally and what accounts we had no penetration in, at least from a Scoli standpoint, and now we are either there or we believe we're the market share leader. And in this quarter, we extended our share gain in both of those aspects. We added more customers, and at least in one of these 7D deployment circumstances, we had an account where we did a ton of trauma limb deformity, but we had basically no exposure on the Scoli side, and instantly we go from no exposure to a share gain position because of the 7D deployment.
That's great. Turning to another product. And again, my goal today is really to highlight some of these big driving sort of tidal wave kind of adoption trends. Let's talk about your very robust PNP Tibia launch. What's a PNP Tibia first for those who maybe haven't heard? But you said you had a strong year. You highlighted that in the Q3 , you had more PNP Tibia sets were launched and surgeons are adopting them at "remarkable rates." That's strong language, even for you, Dave. What's that mean? Can we get some numbers from your saner more grounded partner over there?
Yeah, so PNP Tibia is a rod, an intramedullary device that goes inside the bone of the tibia. It's used for fractures. And I think that was the primary use case when we developed the product. And then what we're seeing is it's also being used with complex limb reconstruction and limb deformity, either for lengthenings or for some kind of derotation. And it's akin to our intramedullary device, the PNP Femur. So PNP Femur is a rod that goes in the femur. We launched that product about five years ago. It continues to grow very rapidly. And it's our largest trauma product, PNP Femur. The reason I think we were a bit surprised by PNP Tibia's growth and now building a lot more sets at this stage is this is a bit of a new procedure for the pediatric surgeon population.
very common to put rods inside femurs, but because of the growth plate on the top of the tibia, it's maybe less common to utilize an intramedullary device for tibia fractures and deformities. And so we weren't clear as to how fast the market might shift their usage from plates and screws or external fixation to this device. And I would say that because of the way the device is designed and how it's inserted, we're pleasantly surprised by the volume of surgeons who are moving from what they were doing before to what they want to do now, which is PNP Tibia. And I think we said, I believe in May, we hit our annual sales goal for the product. So you can imagine there's a lot of demand here and we're building sets, put 25 more out. But to give some context, there's 300 children's hospitals.
I think we have 50 PNP Tibia sets out there. So we've got a long way to go to continue to grow that business.
Anything you want to add, Fred?
Absolutely not.
It was actually a good answer there, Dave. Thank you. Let's get to the topic of 2025. I mean, and we've sort of set it up here. I mean, exciting new launches. We're talking about a full recovery, strong execution. Fred, at the September Investor Day here in New York, you outlined your new long-range financial targets. And you talked about high teens annual sales growth for the next three years. This is a bit slower than maybe we've seen in the past. You're a bigger company. But maybe I'm too optimistic, but it just seems like the breadth and depth of your innovative engine would argue for more. Why is upper teens the right place? And what the heck does upper teens? I don't trust you anymore. Is that 18 to 19, 17 to 18, 16 to 17? What's upper teens?
It's 15%-19% is upper teens.
Oh, great, great, great, great.
Since you opened the door. The business has a ton of growth drivers. But as you mentioned, the business is much larger today. And so growing at 20% on a $200 million business, we're creating a business the size that we were when we did our IPO just seven years ago. And as that number gets larger, that growth number that we have to create becomes a larger and larger number. So we definitely wanted to make sure in the analyst meeting that we got the high teens number out there. We're confident in that. That is the public number that we're defining. And internally, we're obviously putting plans in place with all of these growth drivers that we've talked about to continually grow the business aggressively and to beat that number.
I think it's important also that in today's environment, we think the right mix is growing the business in that high teens range, but also dramatically improving the Adjusted EBITDA of the business. We are very pleased to have an $8-$9 million positive Adjusted EBITDA here in this year. We'll be growing that significantly next year, and we'll continue to grow that year after year after year, and we think it's a bit unusual in that we're having a pretty high growth company generating positive Adjusted EBITDA. In 2026, we'll get to positive or break even at least cash flow for the business, so it's a balancing of all three of those metrics.
Gotcha. Street's at $240 million in sales, that's 18% growth. Does that align with your thinking, Fred?
We haven't provided 2025 guidance yet, but that is a high teens number, yes.
You're smiling. You're smiling. So I feel like I feel good about it. Let's talk a little bit more about OPSB. And again, just briefly remind everybody what OPSB stands for, Dave. But you closed the acquisition of a Florida clinic as well related to this. You expect to complete more clinic acquisitions by year-end. Each clinic, you said, is going to generate $1-$3 million once it's fully ramped. So how many do you want? What's the opportunity? How big do you want this part of the business to be? Help us think through what kind of growth contributions can be and the importance to this story going forward.
Yeah. So OPSB is OrthoP ediatrics Specialty Bracing. So OPSB really is, like Fred said, 80% of what our surgeon does is not taking a kid to the operating room. And so this is an opportunity for us to provide both products and services to this patient population and our surgeon to ensure that hopefully we avoid taking kids to the OR. About a third of that business is scoliosis. The 70% or so is on the trauma limb deformity side. So these are preoperative and postoperative braces. They're functional braces. They're prosthetics and the fitting of those prosthetics. We've outlined really three growth strategies here inside the OPSB space. Number one, when we bought in Boston, there were 26 clinics there. And I would say certain clinics had pretty high market share, those in the Boston area.
But a lot of the other clinics, I mean, the clinicians in those clinics actually don't connect with the surgeon, which there was no sales channel. So that's the benefit we see in Boston where our clinicians, our people within the hospital are directly connected to these patients and to the surgeons to make sure they get better outcomes. So we're working hard with the specialty sales force, the OPSB sales force to drive the connection between the existing clinics we have and our existing customers of our implant business to make sure that they even know we exist such that we can drive more volume through those clinics. We cite about 15% market share in the 26 clinics or so. We'd like to drive that to 50%. We don't see any reason why we couldn't do that. We provide a better service. There's really no competition for this.
It's just raising awareness and providing great service. Then we talk about new product development. I think four or five new products we think we're going to be able to develop year in and year out. We sell those products to other clinics we don't own. So kind of we can retail these products to other clinics and then those clinics fit these for the patients. Or we obviously sell it through to the patients kind of where we're a retailer directly to the patient and we fit the braces. So that's a big driver for us. And I think the biggest and the longest-term growth driver for us is territory expansion, setting up more clinics. When we started this business, we had the aspiration that we would be in every major children's hospital in the United States. Now we're in basically every major children's hospital in the world.
You could assume that our aspiration, particularly in the United States, is going to follow suit. There's no reason why we wouldn't have a specialty bracing clinic in every major jurisdiction and around every major children's hospitals in the United States. And when you think about that as a $500 million TAM where there is really no competition, this is a matter of the infrastructure build over a period of time necessary to own that market share. And it's our intention and we see no resistance to that. It's just going to take some time.
Yeah. No, it's an exciting part of the story. Just to mix it up a little bit, gross margins in the Q3 were a tad weaker than I thought, Fred. And you said greater than expected P3 unit sales and scoli set sales in Latin America, both lower margin. Can you expand on that? And what's the setup here for both Q4 and into next year as we contemplate gross margin?
Yeah, absolutely. So at the beginning of the year, we said 74%-75% gross margin for the full year. We had assumed in there selling some 70 units. We just didn't know which quarter that would happen. And so a couple of those got stacked on top of itself here in the Q3 . We also, as you mentioned, Scoli internationally grew by more than 100%. A lot of that was opening new territories in Latin America, which is selling sets at no margin. So both of those factors definitely brought down the Q3 in particular margin a little lower than it was previously or last year in the Q3 . We reconfirmed our full year guidance is still intact at 74%-75% for the year. It's also the same number that we have provided for the next three years.
There's a lot of mix in the business, but on an annualized basis, we're confident in that 74%-75% range.
I'm going to stop having a spreadsheet for kids and have just a product list. And every time we do these, I'm just going to go down this. There's too many. We haven't talked about ApiFix. When will ApiFix growth pick up? It started with such promise, but the Investor Day, you said the growth rates are going to be more modest. Maybe you'll help us understand what that is in coming years as you develop registry data. What's going on? I know it's not the product, but what's going on? Help us think through that story.
Yeah. So I think that number one, if you're sure you already read this publication, but the Journal of Pediatric Orthopedics.
I read it this morning. Right. I got up early.
So you would know then, Rick, that we made the cover of the Journal of Pediatric Orthopedics in October with our data related to ApiFix that showed very, very strong results. And that was led out of a number of surgeons. But when Mayo Clinic is the highlight at the top of that list, along with very, very widely recognized institutions, that's probably good for our business. And I think what we're seeing in the longer-term data, you got to imagine now we got two-year, three-year data that's starting to come out. We're defining the patient population that this works really, really well in. And so what we may be seeing is a slight shrinkage of our total indications, meaning surgeons should probably not think of ApiFix as the end-all, be-all for every patient, but that there's a certain patient population that this works really, really well in.
And so I think that our higher volume surgeons, we're seeing their volumes move into the band where the product works best. And then the surgeons who used to say maybe, "Hell no, we're never going to do this," are now saying, "Hey, this data looks pretty favorable for this particular patient population." And so it's kind of odd in that the growth in terms of the total user base is expanding very rapidly. It's just that that patient population that they're treating within that band is a little bit narrower, if that makes sense.
Gotcha.
Our opinion is that ApiFix belongs in the repertoire of products that a pediatric orthopedic spine surgeon should use. And there is a patient population within them that every surgeon could identify with. That's the right patient for ApiFix. And as we continue to grow that installed base of users, the product line is going to continue to grow. And I think that's why you heard Greg say, "Hey, we're not looking at hockey stick here, but we expect that this becomes a product that's ubiquitous inside the practices of every pediatric spine surgeon.
We only have 50 seconds. Talk just briefly about innovation engine here. How much looking ahead is going to be M&A, outside M&A? How much internally? And is the pipeline full? I mean, what are you most excited about?
Yeah, I think right now, as we look at what we've got in front of us, the early onset scoliosis side of our scoliosis business is super exciting. We've got the biggest, I think the most impactful product we've ever developed on the trauma limb deformity side in P3 that's going to start to launch next year. And then if you look at the robust volume of new products on the OPSB side and the fact that we have a capacity to scale into what is a massive TAM for us, you look at that across a three-year period of time, kind of the planning horizon, and it's extremely exciting. Frankly, I wish there were more things to buy that had a focus that we could scale. We've done fantastic work scaling the assets that we've bought, but there are just not that many technologies in peds ortho.
I would say that when we get back on the M&A side, it's when we start to see the growth slow in the pediatric orthopedic space several years from now and start to look at other subspecialties in pediatric healthcare where we think we can bring to bear the infrastructure that we've built by helping in ENT or cardio or general surgical or something like that. That's a ways out, I would say.
Gotcha. And Sole source contracting, of course.
Sole source contracting.
On that note, I thank you both. I mean, it was a great session and I think we understand a lot more clearly. It's a very exciting year ahead.
Thank you.
No matter what Fred says.
Thanks for having us, Rick. Thank you.