KIDS - NASDAQ

Good morning and welcome to OrthoPediatrics Corporation's Third Quarter 2024 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 replay purposes. I would now like to turn the call over to Trip Taylor from the Gilmartin Group for a few introductory comments. Please go ahead.

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, I encourage you to review the company's most recent annual report on Form 10-K which was filed with the SEC on March 8, 2024. 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 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, the content of this conference call contains time-sensitive information that is accurate only as of the date of this live broadcast today November 7, 2024. 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, Trip. Good morning, everyone, and thank you for joining us on our third quarter 2024 conference call. As always, we are extremely proud to open our call by reporting that we helped over 33,000 kids in the third quarter of 2024, a 50% increase year-over-year and another record high for OrthoPediatrics. Having helped over 100,000 children so far this year and over one million since our inception, we continue to deliver on our costs while expanding our reach and positively impacting the lives of more and more children worldwide. This has and will always be our foundation and remains the best measure of our success. At our recent Investor Day held early in September, we provided a deeper look into our business, dedicating time to each business segment and how we plan to deliver value and support our cause now and in the future. We clearly articulated our three-year plan to deliver topline revenue growth in the high teens and greater than 20% for OPSB, produce substantial EBITDA, while improving EBITDA margin and become cash flow breakeven in 2026. Our strong Q3 performance represents yet another successful step forward in our plan, as we continue to execute and further enhance OrthoPediatrics' unique and differentiated profile. To that end, OrthoPediatrics' strong performance continued in the third quarter of 2024, as we delivered record revenue of $54.6 million, representing global growth of 37% from the same period in 2023. As has been our long history, we continue to take share across the entire business and saw strong performances from both T&D and scoliosis with growth bolstered in both businesses by OPSB. Looking at the overall macro environment, we believe we are finally in a normalized surgical environment with only the possible transient impacts of seasonal viruses such as COVID RSV or flu and we expect to continue as normal into the future. Like other companies, we experienced an impact from the hurricane at the end of September resulting in case cancellations. And again, we were affected in early October by Hurricane Milton. However, given our healthy volumes throughout the quarter, the impact on Q3 was marginal and October trends have been -- have remained favorable. That said, through the first three quarters, we have successfully executed our strategy, as we continue to deliver more positive results. Strong results coupled with our overall bullish outlook and the multiple growth levers that remain ahead of us compel us to raise our full year 2024 guidance to reflect this momentum. We raised our expectation for full year 2024 revenue range of $202 million to $204 million, representing year-over-year growth of 36% to 37%. We expect to extend our growth improve adjusted EBITDA and reduce cash usage as we enter the final months of 2024. Now moving to our revenue segment. In the third quarter of 2024, we generated total trauma and deformity revenue of $37.6 million, representing growth of 31% compared to the prior year period. The results within our T&D business continue to be driven by significant market share gains across several products as well as the addition of Boston O&P revenue. This quarter's performance was highlighted by both trauma and OPSB products including PNP Tibia, DF2, cannulated screws and Boston O&P sales. Within the T&D business prior set deployments, most notably from the aforementioned products, in addition to continued share gain across the entire product portfolio continue to drive our growth and we believe the utilization of those sets will continue to increase. During the quarter, we launched more sets of PNP Tibia, which surgeons are adopting at a remarkable rate and we are working hard to ensure that we deploy sets to meet rapidly rising demand. Thus far, we've executed the PNP Tibia launch exceptionally well and anticipate this will be a solid growth driver for the next several quarters and beyond. Overall, we are seeing the impact of set deployments from 2023 and 2024 and expect further contributions in the future. Surrounding pediatric orthopedic surgeons with all the technology they need to provide optimal care is a key focus of ours. Currently we have 42 different trauma and deformity systems that have been launched over the last several years and our pipeline remains robust. We focus on ensuring that the products we bring to market are high quality and address major unmet needs. PNP Tibia and especially DF2 are great representations of products that provide a unique life-changing impact for our patients. We are very proud of what we see in terms of clinical outcomes and new treatment paradigms and the success we've seen throughout the launch of eLLi is further validation for these products. DF2 recently received an additional FDA indication approval for post-surgical bracing, which will continue to expand its demand. PNP Tibia has now been in the US market for a few quarters and the demand continues to exceed our expectations. And although earlier in the full market release timeline, we believe DF2 is poised to continue rapid growth for several years, as we continue to ramp surgeon access. On the R&D front, we're excited about our progress on the surgical side of our T&D business. In particular, the development of our pediatric plating platform or P3 is progressing according to plan with the first of the series our P3 hip system slated for launch in the first half of next year. This system is specifically for pediatric and adolescent hip fractures and deformities and there's no other product like it today. As such, it represents an opportunity to grow with a new indication. We believe this will be a world-class system with a significant opportunity to fill a major unmet need in the market and spawn further share-taking opportunities for us within the plating franchise. Overall, T&D continues to be a strong performer for us as we leverage our scale, capture market share and bring new products to market that fill unmet needs to drive growth across the board. As discussed in detail at our Investor Day in September, within the OrthoPediatrics non-surgical specialty bracing business or OPSB, we have created a clearly defined strategy that will drive growth and positively impact profitability. Our strategy to take OPSB to the next phase over the coming years and expand the OPSB footprint utilizes a threefold approach: number one, growing market share with existing products in our existing clinics; number two, accelerating R&D by launching four to five new products per year; and number three, aggressive territory expansion. Regarding the first, currently we serve nine target markets across the US. A target market is defined as a greater metro area. Across those target markets we estimate, we currently have about 15% to 20% share of the pediatric orthopedic market on average. Increasing market share within existing clinics, represents the easiest layer of growth as we work to push from 15% to 50% market share. We've expanded our OPSB-specific sales force. And with their hard work we have already begun to see early returns from that investment. On the R&D front, while it's very early and these projects do take time, we will be launching several additional products this year both from our own organic product development and through strategic partnerships. While these products won't have a material impact in Q4, they will be growth drivers in 2025. With respect to territory expansion, we are happy to report that since the Investor Day, we have already made progress on this front. Early in the fourth quarter we closed the acquisition of a small clinic in Florida that allows for aggressive greenfield expansion in this new and important territory. Additionally, we are working on multiple greenfield expansion opportunities that we expect will be completed in the fourth quarter. While all components of this strategy are critical, we believe territory expansion will be the largest driver of growth, especially as we look to 2025 and we look forward to providing updates on this in the near future. We recognize the huge potential within OPSB to drive our patient impact potential for treating more patients with capital-efficient growth and early traction with our strategy suggests that we are on track with our plans to execute through the remainder of 2024 and for the next several years. Moving to the scoliosis business. In the third quarter of 2024, we generated scoliosis revenue of $15.6 million, representing global growth of 52% compared to the prior year. The global growth and scoliosis rebound this quarter was driven by strong case scheduling, continued share gain, the opening of some new large key accounts and the onboarding of several new users along with strong international growth as well as the addition of Boston O&P revenue. More specifically, we saw continued adoption of our RESPONSE Spine system in the US and abroad, strong international revenue, surgeon adoption at large key accounts of our first EOS product RESPONSE Rib and Pelvic and strong 7D sales and placements. Further, we are benefiting from the synergies with the OPSB business and scoliosis bracing products from Boston O&P, which contributed to the strong growth quarter. Scoliosis scheduling was robust for the balance of the summer and has extended into the fall despite case cancellations, due to weather in the Southeast. International scoliosis was strong due to solid revenue in our direct markets, where we're seeing new users come on board and strong ordering from our LatAm stocking distributors. Looking at a few core products. In the third quarter, we had multiple placements and sales of 7D units that will positively impact revenue in 2025. 7D unit placements are critical in driving account conversions in locations, where we have both placed and sold units. Those 7D units were placed in large institutions, where we have a substantial opportunity to grow scoliosis revenue over the next three to five years. However, while the placements will lead to future revenue, selling 7D units does carry a lower margin than the corporate average, which is reflected in our overall gross margin results. Now turning focus to our EOS products. We continue to progress with developing our EOS product portfolio, as we work toward new FDA approvals and launches. We've been in direct discussions with the FDA regarding the approval pathway for eLLi and Vertiglide. Recently, we received feedback that a 510(k) pathway may not be the likely approval pathway and we have already engaged with FDA, to ensure we meet all the data collection requirements needed to secure an approval. While we do not believe that this impacts our opportunity, we do anticipate a slight delay in the timing of the US launches. Promisingly, when we look at OUS, there are multiple international locations and surgeons being onboarded for the first procedures of Vertiglide and eLLi which we expect will positively impact revenue in 2025. We anticipate upcoming cases OUS and we'll be capturing clinical data that will be leverageable in our approval process. Moving to international. Overall, international performance was strong generating revenue of $11.9 million and delivering 12% growth year-over-year. Growth was primarily driven by greater than 100% international scoliosis growth, while international trauma and deformity and OPSB growth were somewhat muted by a difficult prior year comp due to the nearly complete conversion of OUS Pega distributors in Q3 prior year that resulted in heavy set stocking and the addition of OPSB distributors. In general, international demand across the entire T&D and scoliosis portfolio is strong and we expect it will continue to contribute to the overall growth of the business. International growth in the quarter was primarily bolstered by trauma and deformity implant products, including several legacy devices as well as very strong revenue from scoliosis. As we look ahead, we continue working hard to increase the number of pediatric orthopedic products available to surgeons outside of the United States. EU MDR approval remains a large catalyst for our growth in 2025 and beyond, and we are well positioned for approvals. We are awaiting the notified body to finalize our EU MDR status, which we expect to be completed in mid-2025. This will enable the potential launch of several new products in Europe, shortly thereafter. Additionally, we are exploring further expansion opportunities for OPSB and we expect the first surgeries for Vertiglide and eLLi to come from outside of the United States in 2025. Overall, the international business is set up nicely and we believe the remainder of the year, will contribute toward an improved 2024. That brings us to surgeon training and education. In the third quarter, we hosted 94 unique training experiences for over 1,400 healthcare professionals including during SRS, the Scoliosis Research Society, which took place in Barcelona in September. Our team was well represented and highlighted our expanding portfolio of products carrying for kids with scoliosis. In addition to our booth, we hosted multiple surgeon training sessions on our nonfusion treatment option ApiFix, for which a study was recently included in two peer-reviewed publications. It is important that we continue to provide educational opportunities, within the pediatric orthopedic community and we continue to lead industry efforts to enhance these opportunities. With that, I'd like to turn the call over to Fred to provide more detail on our financial results. Fred?

Thanks, Dave. Before giving you more details on our financial results, I want to iterate that through continued execution, we've established OrthoPediatrics as a high-quality and differentiated asset with the ability to scale growth and increase operating leverage, which provides a clear path to cash flow positivity, supported by a very strong balance sheet. With that said, our third quarter 2024 worldwide revenue of $54.6 million, increased 37% compared to the third quarter of 2023. Growth in the quarter was driven primarily by strong performance across global, trauma and deformity, scoliosis and OPSB. US revenue was $42.7 million, a 46% increase from the third quarter of 2023. Growth in the quarter was primarily driven by additional market share gains across trauma and deformity, scoliosis and OPSB as well as the addition of Boston O&P revenue. We generated total international revenue of $11.9 million, representing growth of 12% compared to the third quarter of 2023. Growth in the quarter was primarily led by scoliosis revenue. In the third quarter of 2024 Trauma and Deformity global revenue of $37.6 million, increased 31% compared to the prior year period. Growth was primarily driven by strong growth across numerous product lines as well as the addition of Boston O&P revenue. In the third quarter of 2024, scoliosis global revenue of $15.6 million increased 52% compared to the prior year period. Growth was primarily driven by increased international scoliosis revenue, new users of our spine system, RESPONSE 5.5, 6.0 as well as 7D. Finally Sports Medicine other revenue in the third quarter of 2024 was $1.3 million, compared to $0.9 million in the prior year period. Turning to set deployment. $5.3 million of sets were deployed in the third quarter of 2024 compared to $3.9 million in the third quarter of 2023. Year-to-date, we have deployed $17.4 million of sets compared to $16.1 million at this time last year. Touching briefly on a few key metrics. For the third quarter of 2024, gross profit margin was 73% compared to 77% for the third quarter of 2023. The decrease in gross profit margin was primarily driven by product mix shift including additional 7D unit sales, which as capital equipment are sold at lower margins than our corporate average and increased set sales internationally as well as less favorable purchase price variance as compared to the third quarter of 2023. Total operating expense increased $10.2 million, or 29% compared to the prior year period to $45.6 million in the third quarter of 2024. The increase was primarily driven by the addition of Boston O&P substantial increases in the spend related to EU MDR certification increased commission expense and the incremental personnel required to support the ongoing growth of the company. Sales and marketing expenses increased $2.8 million, or 20% compared to the prior year period to $16.8 million in the third quarter of 2024. The increase was driven primarily by the increased sales commission expense coupled with additional employees to support OPSB sales growth. General and administrative expenses increased $8.3 million, or 46% year-over-year to $26.3 million in the third quarter of 2024. The increase was driven primarily by costs associated with the Boston O&P acquisition increased depreciation and amortization over $600,000 increase in expenses related to EU MDR certification as well as personnel and resources to support the continued expansion of the business. As discussed on our prior quarterly earnings call the addition of Boston O&P includes lighter sales and marketing as well as R&D expenses; however heavier G&A expenses. Research and development expenses remained flat at $2.6 million in the third quarter of 2024 due to timing of external development expenses. Total other expenses was $3.6 million for the third quarter of 2024, compared to $0.8 million of other income for the same period last year. The increase was driven by onetime refinancing expense of $3.2 million. Adjusted EBITDA was $4.0 million in the third quarter of 2024. This compares to $3.6 million for the third quarter of 2023. Year-to-date adjusted EBITDA was $5.5 million, compared to $3.8 million in the prior year. We ended the third quarter with $78.1 million in cash short-term investments and restricted cash. We still have $25 million available to us on our new line of credit. Turning to guidance. We are raising our expectation for the full year 2024 revenue to $202 million to $204 million, representing year-over-year growth of 36% to 37%. We continue to expect full year gross margin to be in the range of 74% to 75% and we continue to expect to generate between $8 million and $9 million of adjusted EBITDA in 2024. Additionally, we continue to expect less than $20 million of new set deployed in 2024 and this represents our continued focus on driving the business to cash flow breakeven by 2026. I'll now turn the call back over to Dave for closing remarks.

Thanks Fred. As we're now through three quarters of the year, we remain very bullish about our opportunity and the position we've established. We believe that over the course of the next three to five years, we will be able to build a very dominant share position and have a defined plan to achieve this. We are extremely proud that we've continued delivering strong performances, especially within this MedTech market, quarter-over-quarter and year-over-year as we further differentiate ourselves from our peers. We look to carry our strong third quarter momentum through the rest of the year and into 2025 as we continue to help more children than ever and capture share across the entire business as we break revenue records, maintain healthy margins, and leverage disciplined spending to yield double our adjusted EBITDA over the prior year and capitalize on roughly $5 million less cash used in set deployment. Operator, let's open the call for Q&A.

Thank you. We will now begin the question-and-answer session. [Operator Instructions] And your first question comes from Matt O'Brien with Piper Sandler. Please go ahead.

Good morning. Thanks for taking the question. Just for starters, I don't know, Fred or Dave if you guys talked about the Boston O&P performance in the quarter specifically, but was that in line with your expectations? And did you see any demonstrable shift between T&D and Scoli in terms of where you're generating that revenue?

Yes. I think we see Boston performing as we expected. Obviously, because of the addition of a sales channel, we're starting to already see the early positive return as we called out of patient flow into some of those clinics. So we talked about a 15% share, we think in our nine territories at the Analyst Day and our aspiration here over the next several years, is to get that to 50%. I think we can confidently say that the impact that the selling organization is having in driving patients and notifying our customers that we have these services in our territories is working. I wouldn't say that it's driving huge amounts of that growth. But certainly, it's heading in the right direction. We expect that to continue. So, really positive there. I think the mix is basically the same as it's been all year. So we didn't see any more scoliosis. I think you may be getting at that 52% scoliosis growth rate obviously really, really big. It was definitely not driven by an overperformance on the Boston O&P side, at least on the scoliosis.

Okay. And that kind of dovetails into the next question too, and I'm not trying to have a got you moment here. But when I kind of pull out, I think what you did in specialty bracing and T&D, it looks like things slowed down there somewhat. I don't know if that was hurricane related. I don't know if it was, because all the sets weren't out there. Is there something you can point to in terms of the T&D performance, that's a little bit lighter here in Q3 versus kind of some of the trend line that we've been seeing over the last eight to 10 quarters? Thanks.

Yeah. Might not have been obvious, but I think Dave talked about that, in his opening comments. So last year, we opened, South America in a big way with a stocking -- multiple stocking distributor orders on the Pega side. And that opens the market for us, for future growth, but it was a one-time very large order that did not repeat in the third quarter of this year. So that's probably the single biggest delta year-over-year in that business.

Okay. Fred, I don't mean to push anymore, but just if you look at even the two-year stacks though Q1 of this year and Q2 of this year, Q3 even if you adjust for that it's still a deceleration. So is there anything else to call out there? Again, I don't know if there was something on the CP side, where cases got canceled or anything along those lines.

No, Matt. I mean, we had a good quarter. From our perspective domestic trauma especially was extremely strong. I guess, domestic deformity was in line wasn't as strong I guess as there are some quarters in the past, but I think domestic trauma was about as strong as we have seen it. And I think when we look at the agency sales outside of the United States for our trauma products, it was in line with what our expectations were. I think the biggest issue for us is just both in LatAm as well as markets in Europe when we had big conversions of Pega distributors that fall into the deformity section of our deformity and trauma business. Those are big numbers for us last year and not as big this year obviously. But there's nothing within that business that we're at all concerned about at this stage.

Okay. Got it. Thanks so much.

Thank you.

Thanks Matt.

Your next question comes from Mike Matson with Needham & Company. Please go ahead.

Hey guys. It's Joseph, on for Mike. I guess maybe to start off could you maybe give us what organic growth -- organic revenue growth was in the quarter? And then, just looking at guidance saw the raise, but just kind of curious what's your outlook for flu and RSV. I know you guys had talked about in the past that you really have it kind of more under control moving forward. So wondering about that and just children's hospital staffing is that kind of still in good shape?

Yeah. So first question organic revenue. I think we gave guidance or comments earlier this year the Boston acquisition, Boston O&P acquisition was about $25 million that was added in. Of that, approximately 25% of that showed up in the second quarter 25% of that showed up in the third quarter historically. And then, if you split that 70% of that is on the trauma and Deformity side and 30% of it is on the Scoliosis side. And so that would give you the ability to do the math as you wish on the organic side. The second question was related to -- sorry the second question...

Yeah. Flu and RSV season -- guidance and then Children's hospital staffing.

Yeah. So on the RSV side, if you look at the data out there that's published CDC typically it starts to pick up a little bit in October and then it spikes in November and December. And if you look at the data just in the month of October, compared to October of last year it is lower than it was in October of last year. I think November, December and January are really the months that have the impact. But if you'll recall in the fourth quarter of last year, the hospitals did a better job of handling the influx. So two years ago it caught the hospitals by surprise. Last year the trend was -- it was still the second largest we've ever seen, but it was down 25% compared to the previous year and the hospitals did a better job of handling it. And so right now what's in our guidance is we're assuming the same type of reported cases that we saw in the fall of last year and that the hospitals will be able to handle it in the same manner. Related to staffing, yes, we think that we are now kind of behind that and that we have more normalized. And we see that normalized staffing continuing in the hospitals particularly in the U.S.

Okay. Great. And then maybe just one on 7D, you guys talked about multiple placements at larger institutions in the quarter. So just kind of wondering if there's anything more you can talk about any more color on surgeon feedback or interest there and maybe what the installed base is at this point if you're willing to disclose that?

Yeah. So surgeon feedback has always been extremely positive on 7D. I think, as we told you guys when we started this it was, -- we were probably a little naive in that we hadn't been involved in a lot of capital placements capital equipment sales at the company. And I would just say at this stage, we've learned a lot. And because of the resources that we have now applied on the enabling technology team with people who really know how to do this and know how to do this well I think it's safe to say we have a very large funnel of 7D opportunities. And our expectation is that we get into a cadence where quarter-to-quarter place --we're placing 7D units and we're getting sales of 7D units as well on certain locations. I think the installed base off the top of my head is probably around 20. So we're still early, I would say in that process. And when we think about these placements, I mean, its part of how we think about the growth particularly in the out years. So once these units are placed we're certainly seeing an increase in revenue for our scoliosis fusion business particularly when they get placed and we're going through the trial. But once we get the PO we get the installment, we have a pretty good line of sight into how that's going to impact scoliosis fusion with our RESPONSE system for the next three to five years. And so it's very encouraging this quarter to see some placements particularly in some accounts that I would say, a year ago, we were kind of nowhere in at least in terms of our Scoliosis fusion business. And now to know that we will have a pretty substantial claim to the Fusion business in those accounts in 2025 and over the next three to five years it's encouraging for us in our forecasting of the RESPONSE business and our Scoliosis business in general.

Okay. Perfect. No question then. Congrats on a record quarter.

Thanks.

Thanks.

[Operator Instructions] There are no more questions. I will now turn the conference back over to David Bailey for closing remarks.

Thank you. Well, once again, thank you all for joining us on our call. We have several upcoming meetings where we look forward to meeting all of you, and talking further about the business and our execution of our strategy. So thank you for your time today. And we look forward to seeing you soon. Take care.