Good morning, and welcome to OrthoPediatrics Corporation Third Quarter 2022 Earnings Conference Call. [Operator Instructions]. As a reminder, this call is being recorded for replay purposes. I would now like to turn the call over to Emma Poalillo from the Gilmartin Group for a few introductory comments.

Thank you for joining today's call. With me from the company are David Bailey, President and Chief Executive Officer; and Fred Hite, Chief Operating and Financial Officer. Before we begin today, let me remind you that the company's remarks include forward-looking statements within the meaning of federal securities laws, including the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to numerous risks and uncertainties, and the company's actual results may differ materially. For a discussion of risk factors, including, among others, the risks related to COVID-19, the impacts this pandemic may have on the demand for the company's products and the company's ability to respond to the related challenges, I encourage you to review the company's most recent annual report on Form 10-K, which was filed with the Securities and Exchange Commission on March 3rd, 2022. During the call today, management will also discuss certain non-GAAP financial measures, which are supplemental measures of performance. The company believes these measures provide useful information for investors in evaluating its operations period-over-period. For each non-GAAP financial measure referenced on this call, the company has included a reconciliation of non-GAAP financial measures to the most directly comparable GAAP financial measures in its earnings release. Please note that the non-GAAP financial measures have limitations as analytical tools and should not be considered in isolation or as a substitute for OrthoPediatrics' financial results prepared in accordance with GAAP. In addition, the content of this conference call contains time-sensitive information that is accurate only as of the date of this live broadcast today, November 1, 2022. Except as required by law, the company undertakes no obligation to revise or update any statements to reflect events or circumstances taking place after the date of this call. With that, I would like to turn the call over to David Bailey, President and Chief Executive Officer.

Thanks, Emma. Good morning, everyone, and thank you for joining us on our third quarter conference call. As we start all earnings calls, I'd like to highlight, after refining the calculation of our acquisitions, we helped over 17,000 children in the third quarter of 2022. Since inception, OrthoPediatrics, combined with MD Orthopaedics and Pega Medical, has now helped more than 610,000 children. Doing the right thing for children is and will always remain our top priority. In the third quarter of 2022, we generated record total revenue of $35 million, which includes stronger than expected revenue from our 2 acquisitions, MD Ortho and Pega Medical, and in total represents growth of 39% compared to the third quarter of 2021. We generated domestic organic sales growth of 25% and overall global organic growth of 22% compared to the prior year period. Organic international sales growth compared to the prior year period was 10% and was negatively impacted by unfavorable foreign exchange conversion, volume disruptions in Australia and the EU due to staffing shortages and lower than expected set purchases from stocking partners due to the stronger dollar. Although we generated 39% revenue growth in the third quarter of 2022, this was below our expectations. While the acquisition revenue outperformed our estimates, organic growth was below our forecast. Despite strong commercial and operational execution, surgeon conversions and market share gains, we experienced extreme swings in case volumes in numerous locations late in the quarter. Hospital staffing and capacity constraints and a high rate of respiratory illness, or RSV, negatively impacted case volumes. As it has been published in multiple national publications, which reference many of our largest customers, RSV is filling beds and significantly reducing the capacity for surgery. This started showing up in September and has continued through October. All of…

Thanks, Dave. Our third quarter 2022 worldwide revenue of $35.0 million increased 39% when compared to the third quarter of 2021. Growth in the quarter was driven primarily by continued surgeon adoption, resulting in 22% organic growth. In addition, we added $4.4 million of combined revenue from MDO and Pega Medical. In the third quarter of 2022, U.S. revenue was $26.5 million, a 37% increase from the third quarter of 2021. The growth in the quarter was primarily driven by organic growth across scoliosis and trauma and deformity as well as the addition of MDO and Pega Medical. In the third quarter of 2022, we generated total international revenue of $8.4 million, representing growth of 47% compared to the prior year period. Growth in the quarter was driven primarily by increased procedure volumes, increased set sales to our international stocking distributors as well as the addition of MDO and Pega Medical. In the third quarter, Trauma and Deformity revenue of $23.9 million increased 42% compared to the prior year period. Growth was driven primarily by organic growth from Cannulated Screws and the PNP Femur system as well as non-organic growth from MD Ortho and Pega Medical of $4.4 million. In the third quarter of 2022, Scoliosis organic revenue of $10.0 million increased 37% compared to the prior year period. Growth was primarily driven by increased sales of our RESPONSE fusion system and ApiFix non-fusion system as well as increased set sales to our international stocking distributors as they look to respond to increased backlog. Finally, Sports Medicine/Other revenue in the third quarter of 2022 was $1.1 million, which grew 8% compared to the prior year period. Turning to set deployment. $6.4 million of sets were consigned in the third quarter of 2022 compared to $1.7 million in the third quarter…

Thanks, Fred. Overall, it may sound strange to express disappointment with 39% revenue growth. But there's no getting around the fact that our third quarter performance reflected continued disruptions in the operating environment. We may see continued staff shortages and RSV impact Q4, but it is significant to note our competitive position is as strong as ever, and there is no change in our posture of aggressive continued growth. In fact, our competitive position continues to be enhanced by the prospect of improved profitability, set deployments, increasing surgeon adoption of key new products, 7D placements and sales synergies produced from our 2 successful acquisitions. These catalysts will all drive near-term value and strengthen our market-leading position. We remain on track to continue expanding our profitability. Our bolstered balance sheet will support future growth, and combined with disciplined investment, will drive the company to cash flow breakeven. Finally, our success remains grounded in a corporate culture that places helping children first and at the center of everything we do. All of these factors give us confidence in our ability to continue to successfully execute our long-term strategy. With that, I'd like to turn the call back over to the operator to open the line for any questions.

[Operator Instructions]. Our first question comes from Matt O'Brien with Piper Sandler.

Congrats on the successful SEC concluded and you announced this morning. Wanted to start with the guide for the year, because when I look at the increase in the MDO/Pega guidance, that's up a couple million. So the organic business is actually down about $6 million. Would love if you could maybe parse out a little bit just the impact you're seeing from the pandemic versus any other factors that are potentially impacting you. And then I guess the next logical question is how that leads into 2023 and what you're thinking as far as the business goes as we head into next year.

Yes, I'll talk about the environment here and then have Fred, maybe you take on some of the guide in the future. Matt, I think what we've been seeing here, particularly in September as we noted in the script, is just a really wild swings in terms of volume of our key customers. And so you've got these accounts that I think were starting to really improve throughout the early part of the summer. Still having staffage shortages, but certainly starting to improve. And then you get hit with RSV, and you have the combination of COVID staffing, RSV. And from account-to-account, region-to-region, we saw particularly in September and moving into October some rough wild swings. Obviously, that's impacting -- negatively impacting revenue growth, particularly on the organic side. And I think going forward, what we have seen this in the past, you typically see these very rapid spikes and then a pretty rapid decline. And certainly, this has been noted in a number of publications around these hospitals that have been really tapped out with these RSV patients. But it is our hope -- don't know that we can build it into a guide -- but it's certainly our hope that we would see a month, 1.5 months of this, and this would improve. But it's certainly very difficult for us to speculate as to how fast this -- the RSV, kind of new RSV pandemic would improve. That said, I think as we think about 2023, it would be our expectation that this wouldn't last deep into Q1. And that hopefully, I know all of the marketplace has been saying this for a long time, but hopefully we could get back to some type of normal operating environment as we look into 2023.

Yes. I would just add to that. The one other variable in there is FX. So when you look at the organic business in the third quarter, we were unfavorably impacted by about $700,000. And the real change came in the month of September in Europe, and we anticipate those rates continuing into the fourth quarter. So we'll have another negative impact in the fourth quarter that will definitely, combined with the third quarter, impact the overall guidance that was provided on the organic side of the business. I think the positive is that the 2 acquisitions are doing much better than actually we thought they would be doing at this point. And we see that continuing into the fourth quarter and into next year, particularly as we can get some sets and some inventory deployed domestically on the Pega side of the business. So, very excited about the growth drivers for next year related to Pega.

Got it. That's really helpful. And then just on ApiFix, can you level set us on how the registry/commercial rollout's going? And I know a lot of people are really excited about that. Is it going to flex a little bit more or meaningfully, maybe, in 2023? And then Dave, you mentioned some of these new products you're introducing. It seems like there's a lot of them. Can you just maybe tease out some of the bigger contributors that we should see from a new product perspective next year?

Sure. Sure. Yes, I think that you could expect to see ApiFix contributing more next year in terms of growth. We've always said that we would expect a doubling of revenue from 2022 to 2023. Certainly, this has been kind of fits and starts with ApiFix, particularly early on with respect to COVID and certainly now with RSV. But it's really good to see that -- and I would say at this stage, the volume of commercial cases is probably very similar to the volume of registry cases. We still expect that registry to be closed at some point in time here in the early part of next year. We've had a fair volume of surgeon movement from registry sites into commercial sites. So a number of the cases that we're in fact doing are not going into registry because they're in commercial sites. So that slowed that down a little bit. But overall, we're very pleased with the way we're seeing ApiFix grow, expected to grow next year, and we're extremely pleased with the results we're seeing. And so hopefully we'll be able to publish 2-year results next year, and I think that will also be another inflection point for the product. As far as new product launches, really pleased to see the organic growth of the scoliosis business at 37%. Not too many companies growing 37% organic in the spine world at this stage. And we think that's on the backs of certainly ApiFix 7D, but also some of the work we're doing on -- in R&D, getting some of these derotation instrumentation out. So we would expect next year to see the derotation cannulated screws. The constant work that we're doing on the complex scoliosis side, combined with 7D and ApiFix to be real growth drivers. Obviously next year, we expect to see both MDO and Pega to be growth drivers. Pega particularly when we get inventory, which we expect to get into the first quarter of next year, expect that to be a driver. And then we continue to take share with the PNP Femur. We believe that is a market-leading technology. We think we're going to be able to take a lot more share next year. And then PNP Tibia comes right behind it. So there's a lot to talk about there. And we just continue to give our sales force and our customers new technologies that I think are going to continue to impact the business positively.

Our next question comes from Rick Wise with Stifel.

It's Anton on for Rick. So maybe first, last quarter you talked about a $2.5 million U.S. deferred procedure backlog kind of expected to be rescheduled throughout 2022. Can you talk to us a bit about how the 3Q, like RSV headwinds impacted the U.S. backlog? Has it become kind of larger now that elevated RSV volumes have kind of weighed on pediatric hospitals' ability to perform procedures? And when do you think the backlog could be fully worked through? Is it like a positive tailwind for 2023 sales performance?

Yes. I'd say at this stage, it is very difficult to determine the magnitude of that backlog. It's harder outside of the U.S. We know it's there. And certainly, we expected and was built into our guide in the second half that we would have extinguished that. And based, again, on what we saw throughout the summer, felt like we were starting to really pick up some steam there. I mean, there's no doubt that our children's hospitals are not operating at full tilt right now. We have surgeons that are anecdotally telling us they're scheduled out right now through the early part of summer next year with major elective procedures. And so while on one stage that is really good, on another side of that, that was fairly uncommon and is indicative of just the capacity right now within these children's hospitals. So the backlog is probably growing. I think Fred and I at this stage are having a hard time trying to quantify what that backlog is, particularly when we see hospitals operating at 80%, 90% capacity, particularly for these really complicated surgeries. I would have to guess this is a tailwind for us when we can get back to a more normal operating environment. And hopefully we see that in the start of 2023, but it's very difficult to quantify at this point.

Okay. Got it. And then on 7D, your prepared remarks about the St. Mary's placement driving RESPONSE pull-through was very encouraging. I think you mentioned last call that your strategy for 7D placements was to target accounts with low OP penetration. Can you give us any additional color into the pull-through you're seeing there? How much further could it go? On additional hospitals kind of currently demoing systems, I guess what's left to be done there for them to convert? And how many systems could we see come through next year?

Yes, it's a great question. So I would say, to use the cliche, we are literally on the 1 yard line, on the goal line here with a number of key accounts, and a number of those key accounts are relatively new users of RESPONSE. And so we're a signature or so away from placing some of these units on contract. It's taken longer than we would have expected. I suspect we're in the same boat with a lot of people at this stage. But we expect that this will have an impact. Certainly, it's 2023. We expect to be able to place the units that we acquired this year and then acquire more units and place more units in 2023. And you're exactly right. We have 4 or 5 accounts right now that literally had no exposure to the RESPONSE system in our scoliosis product. They were customers of ours on the T&D side, but now they're using RESPONSE. And they're using RESPONSE even before they're contractually obligated to do that through a unit placement. So we really like what we're seeing there. And I think that 7D, again, 7D, ApiFix, these types of things are certainly driving the 37% organic growth we saw in Q3, even in a really choppy environment. And we would expect to see that positive uplift due to 7D continue throughout the balance of the year as well as the balance of next year.

Our next question comes from Ryan Zimmerman with BTIG.

Want to follow up on Matt's question on RSV and just ask a little bit. Dave, do you feel like you've sufficiently accounted for the full impact of RSV in the fourth quarter? Given how volatile it is, I just want to make sure that you guys feel confident with the guidance that's set for fourth quarter and 2022.

Yes, great question. RSV, as Dave mentioned, spikes really, really fast if you look at the trend charts on the CDC website, and then it comes down really fast as well. It seems to have started about 2 months earlier this year than years past. And so we anticipate that will come back down in the fourth quarter, sometime in the fourth quarter. And we feel pretty confident in the guidance that we have fully reflected that as well as the unfavorable FX that's going to be impacting the business. We would anticipate, hopefully, that we can get this behind us and start recovering a bit before the end of the fourth quarter and then starting into the first quarter. So good question. We think we've got it adequately bracketed, if you will, and included in the guidance.

I think Fred and I are becoming honorary virologists here. And so we have certainly been involved in a lot of conversations with our accounts to try to gauge exactly how it's impacting them.

Yes. No, that's helpful, because clearly I couldn't call it, even though I thought I tried. But I want to ask about -- I appreciate the disclosures on organic growth. I think it's a question investors have been asking for on OrthoPediatrics for a while. And so maybe you could just talk a little bit, Fred. The M&A contribution was up about $2 million, better than we expected from the prior guidance. What do you -- one, what can that run rate next year in terms of kind of your expectations? Then 2, I did notice that you did a little bit over $4 million this quarter, but you're implying $4 million in December. Is there a reason why that slows down? Is that seasonality? Just kind of take me through your thinking around M&A and the contribution from the businesses.

Yes, absolutely. As we mentioned, both businesses are doing better than expected, particularly Pega in the month of September, once it got into the hands of our domestic sales agents. And so very pleased with the third quarter performance. Both of those businesses follow the same trend as our seasonality in our legacy business. And so as you know, in the fourth quarter, typically the sales are softer than they are in the third quarter because the kids have obviously gone back to school. And so that reduction that is included, the $4 million versus the $4.4 million, which you are correct, is really just driven by the seasonality of the overall pediatric business that's included in there. Listen, both of these businesses are very exciting, and we anticipate that the growth of both of these businesses will be faster than the overall revenue growth for our business in all of 2023 and probably beyond for a few more years. So as Dave mentioned, really on the Pega side, it's a matter of getting sets deployed. That will start in the first quarter and tail out into the second quarter and probably continue into the second half of next year as we continue to deploy sets in that business. And on the MDO side, the product launches, we opened Brazil for the first time with them. We have a lot of distributor relationships in Brazil. They were not selling there historically. And so encouraged to have that country open to clubfoot correction and more to come.

Our next question comes from Sam Brodovsky with Truist.

I'll just add one more on the acquisitions. And then -- so can you parse out at all a little bit maybe the mix between -- in that $4.4 million between the 2? Is it reasonable to think sort of a flat sequential for MDO, or is there an increase there from 2Q?

Yes. So the businesses combined, I think about half of it was domestic, half of it was OUS. So both of those businesses are more international than our legacy business, which is about 25% outside of the U.S. And again, we saw nice growth from both MDO as well as Pega within the quarter, and we anticipate that continuing.

Okay. And then maybe just on MDO, if we think about that 2Q with the continued success, is that $2.6-ish million revenue, is that like a reasonable run rate to think for next year?

I think that's reasonable for this year. It should grow on that for next year.

Great. That's helpful. And then just at a higher level, when we think about the algorithm to get to 20% organic growth. Scoliosis has been performing really well the past 2 quarters on an organic basis, and mid-teens growth, call it, for the Trauma and Deformity business. Is that how we should be thinking about the businesses in 2023 and beyond? Or is there maybe going to be some acceleration in the Trauma and Deformity business?

Yes, I would expect the Trauma and Deformity business to continue to accelerate, again, when we get back to a more normal environment, particularly on the elective deformity correction side. We had a fantastic quarter of taking share on the -- in the external fixation franchise. The devised rail, combined with Orthex, has had a big impact. And we expect that to -- that, combined with PNP and Cannulated Screws, to continue to drive growth throughout the balance of 2023. Obviously, the scoli business is growing faster. It has historically grown faster. And again, with ApiFix and 7D, we would expect that business to continue to grow. But I think when you combine Pega and MDO and all that we've got going on the T&D business now in a normalized environment, as well as everything we've got going on the scoli business, it's -- we are very bullish about our capacity to grow organic sales growth by north of 20%.

Our next question comes from Mike Matson with Needham & Company.

I wanted to ask about the trademark impairment. I didn't completely understand what that was related to.

Yes. Both the trademark impairment and the $23 million on the accretion, both of those are related to ApiFix.

Okay. Does that imply that the sales have been lower than you expected or planned for?

Yes. So the way that works is we provide a forecast, 10-year forecast, actually, to a third party who goes through a valuation analysis, and that was completed and updated here in September. And that [Technical Difficulty] forecast, which it is lower than we had anticipated, impacted the impairment, and then that flows through to the accretion analysis as well. As a reminder, the accretion is related to a 4-year system sales payment, so it's an earnout in April of 2024.

Okay. And to what degree -- I mean obviously, you were launching this thing during a pandemic. So I mean, is it mainly related to COVID, or were there any other issues there that caused it to maybe not do as well as you thought or be slower in terms of the ramp?

I would just say that we were obviously much more bullish when we didn't know we were going to be facing 3 years of a COVID environment. So when we acquired this business during the first month of the pandemic, I think we expected the rollout and the registry and everything obviously to be filled much quicker. And that I think from our standpoint long term, we have really no change in our view of what this technology is doing. And obviously it's growing our scoliosis business in a substantial way, even though it's still relatively small. I think that the expectations for this business, given the impact of pandemic and everything else, it probably pushed out a few years, and that certainly impacts the valuation.

Absolutely. Okay. And then just we're seeing this merger with Orthofix and SeaSpine. And I know Orthofix is probably one of the few companies out there that had some sort of pediatric business, probably more in the trauma and deformity area than in spine, admittedly. But I'm just wondering what your views are on the deal in terms of what it means for OrthoPediatrics. I mean I'd imagine there's probably going to be some disruption as they combine the companies. But longer term, is there a risk that they could become more of a larger player in the pediatric market maybe?

Yes. Our biggest concern upfront was just how we ensured that we had this -- a very strong partnership with SeaSpine and know the management quite well there. And the biggest concern was just to make sure that we were all still full go in terms of the 7D arrangement, not just on the scoliosis side, but work that we're doing in partnership to develop technologies on the trauma and limb deformity side. And we're very confident that that's a full go. So I guess, I can't comment for sure on what's going to happen there, but Orthofix was -- didn't particularly impact our revenue growth as a standalone company. My suspicion is that this won't have a big impact or any impact on us as they try to integrate into an adult spine company. And I think that probably provides us with some real opportunity if there are some places, particularly outside of the United States, where they may see disruption, some nice opportunities, particularly with our expanded international footprint post-Pega acquisition.

Okay. And then finally, just given where the gross margin was, doesn't look like you're really feeling any major kind of inflationary pressures, but just wanted to check in on kind of what you're seeing with regard to inflation and your supply chain.

Yes, that is absolutely correct. I mean, there's a little inflation obviously in transportation and a few pockets here or there, but nothing that's impacting the margin of the business today or that we would anticipate in the future. The lowering of the set deployment numbers by a few million dollars is some leftover legacy problems from suppliers, again, trying to get that one last instrument into the set before we can deploy it, and some dates are moving out for deliveries from some of our suppliers. So that'll push some of the deployment into next year. But inflation wise, we're in good shape.

There are no further questions at this time. I'd like to turn the call back over to Dave and Fred for any closing remarks.

Great. And we look forward to talking to several of you at some upcoming investor conferences. Thank you.

This concludes the program. You may now disconnect. Everyone, have a great day.