Good afternoon, and welcome to the OrthoPediatrics Corporation's Third Quarter 2021 Earnings Conference Call. At this time all participants are in a listen-only mode. We will be facilitating a question-and-answer session towards the end of today's call. As a reminder, this call is being recorded for reply purposes. I would now like to turn the call over to Matt Bacso from the Gilmartin Group for a few introductory remarks.

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 of 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 quarterly report on Form 10-Q, which will be filed with the SEC soon. 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 measures referenced on this call, the company has included a reconciliation of the 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, to the content of this conference call contains time-sensitive information that is accurate only as of the date of this live broadcast today, November 4, 2021. 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, Matt. Good morning, everyone, and thank you for joining us. We hope you're safe and well. Before providing a business update and review of the financials. I'd like to highlight that we helped approximately 10,400 children in the third quarter of 2021, bringing the total number to more than 226,000, since the inception of OrthoPediatrics, doing the right thing for children remains our top priority. Consistent with our pre-announcement on October 13, we generated quarterly revenues of $25.1 million, representing growth of 13% compared to third quarter of 2020. Before commenting on each business segment, I wanted to address three key topics that have a broad scale impact across the medical device industry. First being COVID. While pleased with our mid-teens growth rate in the third quarter, it is important to point out that the recent spike and delta variant cases impacted children more than any other period during the pandemic, thus negatively impacting elective procedural volumes. Secondly, we also saw the impact from hospital staffing shortages and increased cases of RSV, which in recent months have increased dramatically. In September alone, the impact of COVID, RSV and staffing shortages generated our largest number of canceled procedures since April of 2020. While all of these factors negatively impacted elective procedure volumes in the quarter, we view them as transitory in nature. That said, we believe the demand curve to recapture backlog cases will be flattened this cycle. As parents wait for COVID infection rates to decline before revisiting clinics for diagnostic evaluations and staff shortage at hospitals reducing capacity. Given this dynamic, we do not expect to recapture the entire Q3 backlog until early 2022. Lastly, the disruption associated with the global supply chain so far has had little to no impact on our company. We are proud to…

Great. Thanks Dave. Our third quarter 2021 worldwide revenue of $25.1 million increased 13% when compared to the third quarter of 2020. Growth in the quarter was driven primarily by the strong international recovery offset by a difficult operating environment domestically due to increased COVID cancellations in late August and September. In the third quarter of 2021, U.S. revenue was $19.4 million, a 1% decrease from the third quarter of 2020. Due to a deferral of elective procedures in the third quarter from increased COVID and RSB hospitalizations in children and staffing shortages, U.S. revenue declined relative to the prior year period. International revenue was $5.7 million increased to 118% as compared to the third quarter of 2020. From a geographic basis, growth was driven primarily by strong sales in South America and EMEA. Additionally, in the third quarter of 2021, we shipped the largest number of international instruments sets in the last 18 months. In the third quarter of 2021 trauma and deformity revenue of $16.8 million increased 12% compared to the prior year period. Growth was driven primarily by a strong international recovery, continued trauma growth, PNP and cannulated screw growth as a result of ongoing investments in set deployment. In the third quarter of 2021 scoliosis revenue of $7.3 million increased 11% compared to the prior year period. International revenue was the primary growth driver in the quarter, while domestic environmental headwinds mentioned previously negatively impact elective procedures in the third quarter. Finally, sports medicine other revenue in the third quarter of 2021 was $1.0 million representing 46% growth over the $0.7 million in the same period last year. Growth in the quarter was driven by another strong quarter of Telos revenue growth. Turning to set deployment, in the third quarter, we continue to execute our strategy…

Thank you, Fred. We continue to make progress on each of our five strategic pillars, which we believe are key to improving the lives of children who suffer from orthopedic conditions. I would like to conclude by thanking everyone for their interest in OrthoPediatrics, and look forward to updating you on our future progress and meeting many of you at upcoming investor conferences. With that said, I'd like to turn the call back over to the operator to open the line for questions.

Thank you. [Operator Instructions] Our first question comes from the line of Matthew O'Brien from Piper Sandler. You may begin.

Hi, good morning, guys. This is Simran on for Matt. Thank you for taking the questions. I guess I want to start out with the guidance range that you reaffirmed. So at the midpoint that would imply a small step up from Q3 to Q4, which is typically a weaker quarter for the business. And you guys mentioned you still kind of or feeling the impact of those ongoing macro headwinds due to COVID. So can you expand a little bit more on maybe some of the things that you've been seeing that give you confidence in that range?

Absolutely. Good morning. So the first thing is, is that there's definitely a softening of the COVID impact on the business. So while we're still seeing it, it's much, much less than it was during the third quarter. And some of those deferred surgeries are now coming back onto the calendar for the fourth quarter, we're starting to see a bit of that uptick already. So that would be the first thing. The second thing is, the international business did very well for us in the third quarter. And we see that continuing into the fourth quarter, as you said, typically, the fourth quarter is our lower quarter than third. But because of strong international demand, and these deferred cases, coming back onto the calendar, we're confident that the fourth quarter will be equal to or better than the third quarter of this year.

Okay, perfect. And then, secondly, on ApiFix, so you guys mentioned, you've 18 of those IRB sites, when do you expect to hit that 20 site enrolled milestone, and then as you pivot to focusing on the commercial ramp of the product? What kind of revenue contributions are you expecting to book in potentially Q4, and where do you see that ramp going into 2022?

Yes, good question. I'll let Fred, you can comment on the revenue ramp, if you'd like. But I think at this stage, our focus has been up until about a month ago, our focus has been obviously on these registry sites. And we announced in our last quarter earnings call that we would shift that focus, not purely away from the sites, but start to shift some of our focus on these commercial sites, which we did, and we did successfully in Q3. And so it could take a couple months to a couple of weeks, we've kind of been in a holding pattern and getting these other two sites and these other two registry sites completed. But I think that our focus now has, is really on starting to commercialize the product in this first wave through the next 10 to 20 sites. And we saw enormous interest there from sites that we had, frankly, put on the back burner for the last year as we were focused exclusively on the registry. And so we made progress there. We did see some cases already from some of the commercial sites. Obviously, we did additional cases within the registry sites as well. And I wouldn't expect to that in Q4, we would see an outsized influence by those commercial sites in Q4, specifically, just because we're starting to ramp that. That said, because we've been able to decouple the registry sites and the commercial sites, we expect that the ApiFix product line will contribute substantially to our growth next year.

Our next question comes from the line of Mike Matson with Needham.

Good morning. This is David on for Mike, thanks for taking the questions. I just wanted to follow up on one of the previous questions about guidance and the rest of 2021. I mean, it sounds like September was a pretty bad month. But you did know that you saw some improvement. So I just wanted to hear, you called are three impacts deferrals, hospital staffing and RSV. So are you seeing improvement across all those three sources of disruption? And then in terms of guidance, does guidance assume, if they stay where they are, or you see continued improvement across those three factors?

Yes, with respect to the environment, what we saw on Q3 was kind of a gradual worsening of case cancellations that really started in August, we saw the impact of delta. And then as kids started to go back to school, certainly the impact of RSV and when combined the impact of Delta, RSV and then staff shortages, we just did not see the immediate snap back in elective procedures like we had seen at the height of the pandemic in late spring of last year that really snapped back in the fall or the summer and fall of last year. So it happened quickly and we saw a lot cases canceled on August, those cases got reput on in September. And we saw a lot of cases recancel again in September. That said, as we move into Q4, we have, as Fred mentioned earlier, already seen an environment where COVID cases are declining, hospital admissions for RSV are declining. And we are seeing a much more favorable elective surgical environment in October already. And, again, we can't predict this, obviously, no one can, but we would expect to see that continue through the balance of the year and hope that we can see a continuation of progress here into the first part of next year. A - Fred Hite Yes, related to guidance, when we had our second quarter call, we were just at the beginning of the Delta variant really starting to pick up in the U.S. And we didn't know when that was going to have a negative impact on us. But we anticipated it, definitely negatively impacting the second half revenue. And so luckily, we had that built in to the 97 to 101. I would say it happened a little sooner and quicker and more aggressively than maybe what we thought it was going to be. But we feel good sitting here today, we think we've got the majority of that behind us. And really the only thing that's limiting some of the growth right now is the staff shortages at some of the hospitals, which we think is going to continue on for some time. But to Dave's point, we're definitely seeing those deferred cases coming back onto the calendar and getting completed. And we anticipate that increasing throughout November and December.

Okay, thanks for that. That's super helpful. And then my second question is just on the partnership with SeaSpine and their 7D platform. Can you just talk about the size of that opportunity there and maybe share what the economics look like? Is there any sort of revenue sharing component to the partnership or is it more about broadening the technology you can offer? Thanks so much.

Yes, so just broadly to speak about the topic, and then maybe Fred can get into some of the revenue opportunities here. We have been watching, as over the last few years as navigation technology has become more prominent in children's hospitals, particularly with in the scoliosis procedures. When we were asked this question three years ago, it was uncommon, very uncommon for us to see patients who were having their spines navigated with these types of technologies. But it was our sense that over time, that technology that's well adopted in the adult space would ultimately become well adopted in pediatrics. And while it's still a minority of cases that are done with interoperative navigation, it's a growing minority of patients who are treated that way. And so we had walked alongside the 7D technology, like we frankly do with almost every partnership, we've known these guys, as well as the guys that 7D or 7D, as well as the spine for a number of years. And after looking at their technology, and a number of others, we really felt like this radiation free or interoperative radiation free type of technology that gives surgeons complete control of the operative theater and the surgical environment was an ideal product for pediatrics. Beyond that, we see other opportunities in the partnership with SeaSpine and 7D to potentially develop applications outside of pediatric spine. And at this stage, we see no other company that's focusing on bringing navigation solutions to children's hospitals outside of spine. So we think this can have a real impact on the business certainly in the next several years. We like the partnership we like both of the -- we like SeaSpine and 7D combined, good people running good companies, and it felt like a really good time for this partnership. Ultimately, we expect like all companies who do this we expect to gain share, particularly on the scoliosis side. But I think what could be unique for us is that to bundle this with our scoliosis platform and in the future potentially bundle this with trauma and limb deformity products. And I think this could be key to large account conversions for us in the future.

Yes, that's right. And when you combine this with Mighty Oak Medical, we 7D and Mighty Oak Medical, both radiation free offerings that increase the accuracy of screw placement. And to those we view them as enabling technologies, meaning that they're going to pull through more of our product sales. And so with 7D we probably will be not selling a lot of these units per se, but more placing them in hospitals with earnout agreements with the hospitals to pull through more scoliosis sales initially, and today's point eventually point through more of our trauma and deformity correction, product sales. We'll see what that looks like. It's not going to have an impact in 2021. But we do anticipate it's starting to have an impact in 2022 and then beyond.

Our next question will come from the line of Ryan Zimmerman from BTIG.

Just two for me upfront. Number one, just the instrumentation increase internationally. Fred, I'd love to understand kind of what the capacity is from the distributor base or for Dave, what the capacity is for more instrumentation and kind of where they're at in terms of their demand, relative to kind of expectations or what you think over time? And then, the second question, just love to understand kind of the interplay between ApiFix and RESPONSE and how you think ApiFix may or may not impact your RESPONSE sales as maybe more parents and physicians choose to go with ApiFix. Thank you.

Yes, absolutely. So very pleased in the third quarter, to start to see some demand of our partners outside of the U.S., requesting sets that they can then purchase, which enables them to grow their business. This is the largest set sail quarter that we've had in 18 months, as many of our partners outside of the U.S. are small family run businesses. And they were trying to get their feet back underneath them related to cash because of the COVID cases, obviously, last year, particularly in Brazil, the beginning of this year was really shut down, they did limited cases, that has started to open up in the third quarter. And as they see the strong demand, and the big backlog that they're facing, they do in fact, need more and more sets to meet that backlog. In addition to that, we're working on quite a few approvals outside of the U.S. of many of our surgical systems, which will then also increase the demand for new sets. And so, we would anticipate that the fourth quarter, and really throughout next year, the set sales should be equal to or greater than what we saw in the third quarter more sets than means more replenishment, obviously, in the future, as well, which grows the overall international business.

Just one thing building on Fred's point, I think one of the things that we probably haven't talked enough about is the fact that a number of these products that we have launched or were just at the beginning of their launch at the start of the pandemic, have been launched in the United States and obviously have been very successful PNP femur now being the largest trauma limb deformity product we have, has really been launched for the most part during the pandemic. And so we like what we're seeing there. And certainly we like the rate of surgeon adoption in the United States. But in most of our stocking distribution markets, we haven't launched that product, we haven't launched Orthex in a very credible way. We certainly haven't launched ApiFix in some of these markets. And so as our stocking distributors return to a position where they can feel confident about their business. And as we've told you guys in markets, like Brazil, there's a massive backlog of patients. And it's just really good to see that, as they start to become confident in their business, they're also confident in some of our newer products that have a history in the United States of being very successful. And I think that's also a motivating factor for our stocking distribution partners to start not only picking up their purchases of products that they have launched over the last several years, but really for the first time launching new products to major new markets. And I think we're experiencing the beginning of some of the tailwind that we had talked about several quarters ago. Just addressing the ApiFix RESPONSE interplay, it's a really good question. One of the primary drivers of the acquisition of ApiFix, beyond the fact that we felt like we wanted to be at the center of game changing technology to improve the lives of kids who are traditionally being fused. The next, maybe the next largest point was the fact that we felt like it would bring certain -- certainly help to drive, the halo effect that we see around the RESPONSE business. And I think when you think about ApiFix, now combined with Mighty Oak Medical FIREFLY Technology, as well as the 7D technology, all three of those technologies are without question driving RESPONSE usage. I think we're seeing a total, we're seeing an increased number of users within hospitals where we already have a foothold. And we're able to open up new accounts as a result of some of those enabling technologies as well as people who have gotten involved with us on the ApiFix side. So really like what we see there and I think as we commercialize ApiFix in a bigger way in 2022, we would expect adoption characteristics of ApiFix to have pretty strong impact on our ability to continue to grow our Fusion Business.

Thank you. Our next question come will from line of Sam Brodovsky from Truist.

And I'll just keep it to ApiFix and ask my to up front. Just want to make sure I didn't miss, there was a number of cases enrolled in the registry at this point. And that's a number you guys have previously given. And then just in terms of shifting towards the commercial model, is there anything you saw in the registry cases that gave you that increased confidence to move towards that? Or is this really a response from demand from your commercial partners for the system and wanting to get them access to it sooner? And how should we think about the ability of these centers to ramp compared to the ramp we saw on the registry centers in -- over the second half of last year and the first half of this year? Thanks.

Thanks, Sam. Great question. So we did not give a number. And it's unlikely that we'll give a number going forward primarily for competitive reasons. These are accounts that everybody is known -- as it's known to everybody. And we are in a competition with another non fusion technology. I will say that between cases that have been performed cases that are either scheduled or approved to be performed here in the next several weeks, we're more than halfway through the registry. And we feel good about that. Certainly the pace of that was impacted by elective procedures in Q3. Now, fact remains is a kids have to come into clinics to be able to be approved for the ApiFix procedure. And we just saw in Q3, fewer X-rays come through from our registry sites, as a result of just a lower census of patients coming into clinics. That said, we're extremely pleased to be on our way to this 200 patients. I expect we'll close that out in the first half of next year. But at the end of the day, what we have seen Sam is really, really strong results in this first 100. And, it's given us and I think the FDA, the confidence to move to the next 10 to 20 sites. We've also seen really strong demand for surgeons, probably some more aggressive or more early adopter surgeons that are outside of the registry, that have wanted to have access to the technology. And so I think the combination of the results we've seen, combined with the interest we've seen from some pretty key accounts in the United States are driving our interest obviously in moving forward with this next 10 to 20 commercial sites. And certainly being able to decouple the registry with our commercial endeavors next year gives us a lot of confidence that ApiFix will have a really nice impact on revenue growth next year.

Thank you. Our next question comes from line of Dave Turkaly from JMP Securities.

Thanks for the color on the cost that you say and I know you mentioned the gross margin was down a bit I think because of OUS mix. But obviously freight does not appear to be something that impacts you guys. But I was wondering if we could get your thoughts on any other inflation that you might be seeing whether it’d be labor or materials of late?

Yes, Dave. Good to hear your voice. Knock on wood. We're very fortunate in that probably 98% of our products come from the U.S. So we are not impacted by the delay in a lot shipping from overseas, which is a huge benefit for us. We've seen a small amount of inflationary impact on the business, but I would say very, very small on ancillary items, the core business has not been impacted and long may that continue. We're hearing that there may be some pressures next year, but it's nothing I think that is going to have any major impact on the business. So right now we continue to have those conversations with our suppliers as we're hearing it from everywhere else. We have very little amount of transportation costs relative to our overall business. And so we think that will not have a major impact on the gross margin. To your point the gross margin declined in the third quarter is exactly what you said a higher percentage of international particularly the set sales, which bill out it to zero margin definitely had an impact on the overall profitability as the domestic sales return, the gross margins should increase a little bit in the future.

Thank you, Fred. And a quick follow up, it would seem to us that pricing power, you may have that given the nature of the products you sell and where you're selling them. But I guess maybe you could just refresh our mind on price increases. Have you taken any do you think you can? Can you offset anything if it does come along in the future? Thank you.

Yes. So we're heading into the budgeting process, as you can imagine, this time of the year. And so every year, this time, we're having those discussions with our business teams, to look at our pricing and look at our margin and not I would say be overly aggressive because we think we have fiduciary responsibility to be responsible for the hospitals, but where necessary, we have increased prices on selective items year-to-year in the past, and we'll continue to do that next year. Any of these inflationary impacts would obviously factor into those decisions on which product add price increases.

Thank you. And I'm currently not showing any further questions in the queue. And this is all the time we have for Q&A. With that, I'll go ahead and close the call. This concludes today's conference call. Thank you for participating. You and now disconnect.