OrthoPediatrics Corp. (NASDAQ:KIDS) Q1 2024 Earnings Call Transcript

David Bailey: Maybe 10%. So to see it performing the way it’s performing with a volume of inventory that hasn’t even been launched, I think that’s going to be a story for us. GIRO, certainly a story for us. DF2 on the OPSB side, that was a product that we developed for fracture care for patients really under the age of four. That has been well-received. So those products, kind of the here and now, we’ve got them in our hands, they’re going well. Started doing first cases with, as I said, our first EOS product line. You hear us talking a lot about the EOS space. That represents about 15% of scoliosis procedures, and up until this point, we’ve never had a product in that space. So, three different products, the first of which we talked about the RESPONSE Rib and Pelvic that just launched, and we have sales going on and procedures going on with that.

Then this Vertiglide device, which is another very substantial, I think will be a strong revenue producer for us. Hopefully we can get it out — in the second half of this year. And then eLLi, as you mentioned, which is the device that was this Electromechanical Growing Rod, just received breakthrough device designation. I mean, our strategy in the early onset scoliosis space is not to provide the customer with a single solution. Most of the kind of adult ortho or adult spine companies may have a single product line for early onset scoliosis. Again, true to a form, we want to surround the surgeon with everything they could use across that very, very complicated set of indication. So very excited. I think all of that creates, again, a seriousness in our product portfolio that requires the top institutions in the world very seriously, because we would be the only company in the world with that type of portfolio for that really difficult set of circumstances.

The FDA, the breakthrough device designation, essentially allows us to have a direct one-on-one with FDA to process the approval of this device. Certainly is no guarantee, Rick, that it gets approved, but based on our testing and based on the capacity to have these one-on-one discussions with FDA and get a very clear sense of what FDA wants to see from us to get this device approved, it gives us a lot of confidence that we’re going to be able to do that. I think it’s the first time in our company’s history, and maybe that’s why I’m personally so excited about this. It’s the first time in our company’s history where we’ve ever had a technology that was deemed so significant to the healthcare of pediatric patients that it got treated this way by the FDA.

I think, I can’t imagine a stronger indication of the need profile for a device like this. For those of us who have been around a while, there’s a certain, well, it’s just a realization of some of our dreams to be able to get involved in some, not just shaping kids’ lives or helping kids improve life, but in some of these procedures, these are potentially life-saving surgeries. Again, I just think it’s a real accomplishment for the company. We think within the next year or so, that device can be out and be implanted in children, and that’s a real breakthrough for us.

Rick Wise : That’s exciting. Thanks for all the color.

David Bailey: Thanks, Rick.

Operator: Thank you. Our next question comes from the line of Mike Matson with Needham & Company. Your line is now open.

Mike Matson : Yeah, thanks. So I wanted to ask about Europe. I think there was some commentary that you’re expecting some new product clearances there. You mentioned an audit or something. Can you just provide a little more detail on what’s happening there? Sounds like it could be meaningful in terms of — the number of new products you’re expecting.

David Bailey: Yeah, great question, Mike. So, basically, you can think about our product portfolio and how it’s developed over the course of the last four years and assume that almost none of those products that we’ve developed, particularly organically, none of those products have hit the European market yet. So, if you just look at the slide deck and see how much we have developed and put out into the US market and certain other markets outside of the US, most of that hasn’t hit Europe, yet we’re still growing very rapidly in the European market. So, you can kind of think of this as really a massive opportunity for us to launch several new brands that are new to Europe. Here we’re at the culmination meeting between the EPOS, the European Pediatric Orthopedic Society, and the Pediatric Society of North America here in DC.

I mean, a lot of these surgeons have seen these products. They’ll certainly see them exhibited here, but they haven’t had access to those products, and markets like Germany, UK, Ireland, Italy, France, Spain. So, this is a big deal for us when we can get this approved. We are ready for the EU MDR audit. Our technical files, everything is updated. We’re ready to roll. It’s just a question, frankly, of getting notified body into our offices. They’re backed up with all kinds of these audits. So, as soon as we get that audit done and we will be ready to start launching these products, I’m not certain we can put a date. Is it November or December or early next year? That’s why we’ve kind of said 12 to 15 months. But when it happens, it’s a big deal for us, and I think it represents the launch of almost four or five years of US products into the European market.

Mike Matson : Okay, thanks. Then I know that you don’t really disclose your sort of organic growth, but if we assume that Boston O&P was sort of like $5.5 million, it implies about 24% growth for the non-O&P business. So, it seems like its safe to assume your organic growth was probably over 20%. I mean, is that reasonable?

Fred Hite : I’d say that’s an extremely reasonable assessment, Mike. Yeah.

Mike Matson : Okay. All right. Thank you.

Operator: Thank you. Our next question comes from the line of Dave Turkaly with Citizens JMP. Your line is now open.

Dave Turkaly : Hey, good morning, guys. Sorry, I’ve been bouncing around a little, so I hope I asked something that hasn’t been asked. But, you mentioned, I think, that you’re going to hire some staff for Boston. I was just curious, could you just refresh our memory in terms of the footprint that you have today? And then I think you even said that you think that you could build that to $100 million. What kind of headcount came with them? And how many people do you need to add? And how quickly can you do that?