OrthoPediatrics Corp.

Hello and welcome to Orthopediatrics Corporation fourth quarter and full year 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 Tripp 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 Height, 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 upcoming annual report on Form 10-K, which will be filed with the SEC on March 5th, 2025. 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 measure to the most directly comparable GAAP financial measure 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 substitute for orthopediatric 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, March 4th, 2025. 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'd like to turn the call over to David Bailey, President and Chief Executive Officer.

Thanks, Tripp. Good morning, everyone, and thank you for joining us on our fourth quarter 2024 conference call. As always, I'd like to start by reporting the metric which most clearly defines our continued success and in which we are most proud. During the fourth quarter, we helped more than 34,000 kids and over 138,000 kids in the full year, both record highs for orthopediatrics. Now having completed our 18th year at orthopediatrics and having helped over ,140,000 kids, my associates and I recognize the positive impact our company has had on so many children and their families, and we take our responsibility very seriously. Our customers and all healthcare providers in the pediatric space have been forced to make do with less than ideal options for children, and we will do everything in our power to right that wrong. While 18 years have passed since our inception, in many ways, OP is just getting started, and our resolve to be a company that eventually helps 1 million kids every year has never been greater. During our journey, we have established orthopediatrics as the clear-cut market leader in pediatric orthopedic implants, and we anticipate our continued execution will lead to a dominant market share position in trauma and deformity correction and scoliosis implants in the coming five years. In the last few years, we have established ourselves as a leader in pediatric specialty bracing with our OPSB franchise. On top of deepening our commitment to the field and meeting more of the needs of our customers, this expansion of our business enables orthopediatrics to grow in a more capital-efficient way. In the coming several years, we plan to execute our clear-cut strategy to obtain market dominance in this very large $500 million marketplace. Given the OPSB business is generating a higher contribution margin than our implant business, these investments will enable us to generate increased EBITDA and improve cash flows. Every day, every quarter, every year, we become more ingrained in the children's hospital by growing our market share and displacing the retreating, incumbent competition and living out our near-fanatical commitment to doing what is right for children and their caregivers. We demonstrate this commitment by delivering new products and technologies that meet major unmet needs, providing unparalleled customer service through the world's only global sales channel in pediatric orthopedics, and through a network of dedicated pediatric-specific orthotists and prosthetists, by our outside support for surgeon clinical education and training, and to put it simply, investing in important things that our customers care about and that impact the field of pediatrics. When you look at the success of our company across our 18-year history, our ability to execute on our commitment, our consistent track record of sales growth through sharetaking, deliberate step-function improvements and adjusted EBITDA, laying a clear path to free cash flow breakeven in 2026, and more recently, our record performance in 2024, we believe our market valuation is entirely inconsistent with the company's performance. We recognize, as a public company, certain metrics and external macro dynamics will always be scrutinized, but we believe the fundamentals of our business have never been stronger. Regardless of the -to-quarter gyrations and variations that can impact valuations for companies like ours, the unshakable truth is that orthopediatrics has carved out a unique position in the public growth med tech sector. Unlike other med tech companies, we are not in a bare-knuckle struggle against focused competition, which gives us confidence in our growth trajectory while allowing us to leverage our P&L, and soon we will produce free cash flow positivity. Therefore, we will continue to be aggressive and execute our strategy on our way to helping 1 million kids per year and creating substantial shareholder value. To this point, throughout the year, and again in the fourth quarter, we have successfully delivered positive results. We have produced extremely strong total revenue of $52.7 million, representing 40% growth from the comparable period. We saw quarterly growth in both T&D and Scoliosis, with 35% and 62% growth respectively, led by domestic strength, with quarterly growth of 52%. We saw a significant increase in revenue from a particularly robust performance from domestic T&D, as well as the addition of Boston O&P. Our international growth was impacted by our decision to slow-set sales shipments to South America, specifically Brazil, in order to reduce AR balances negatively affected by rapid currency fluctuations. However, we still saw extremely strong EMEA T&D growth due to high demand, and OUS Scoliosis growth was great despite challenges in Brazil. With extremely significant revenue growth and more than doubling our adjusted EBITDA during the fourth quarter of 2024, we improved our financial profile and took another step towards free cash flow breakeven in 2026. All of our businesses continue to grow rapidly, entirely from sharetaking, due to continued demand for our products, large-scale set deployments in 2023 and 2024, major new products, successfuly scaling of our past acquisitions such as Orthex, Apithix, and Pega Medical, and the more recent launch of OPSD, and the acquisition and full integration of Boston O&P. With all of these levers in place, we are confident we will continue to reach new highs and deliver important results for orthopediatrists. We expect our business to continue this momentum, and our success in 2025 and beyond is driven by three main factors, execution and scaling of OPSD, sharetaking across the business by leveraging prior set deployments, and ongoing success of our innovative product launches. This year, we expect to generate revenue of $235 to $242 million, representing annual growth of 15% to 18% as we lap the Boston O&P acquisition. Importantly, we also expect adjusted revenue of $15 to $17 million to be greater than $15 million of set deployments in 2025. We also expect to have our first quarter of positive free cash flow in the fourth quarter of 2025. In the fourth quarter of 2024, the T&D business continued to drive 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 OPSD products, including PMP Tibia, DF2, Canulated Screws, and Boston O&P sales. We continue to leverage our prior set deployments, which are driving increasing share gains for trauma and deformity across the breadth of our products. U.S. trauma and deformity was extremely strong, and in fact, U.S. trauma is likely as robust as we have ever seen it in company history. Mainly attributable to set deployments in 2023 and 2024, and the more rapid adoption of our new products, the more likely we will see the growth of our products. In addition, during the quarter, several sets of PMP Tibia were launched, and we expect this will remain an important growth driver for the next several years. DF2 demand is now far exceeding our expectations and is quickly setting a new gold standard for femur fracture management in young children. DF2 recently received expanded indications for postoperative care, which we believe is a much larger market than the femur fracture market. All of this has created the need for expanding our supply chain to meet exploding demand. On the R&D front, we're excited about our projects on the surgical side of our T&D business. Our pediatric plating platform, or 3P, a world-class system with significant opportunity to fill unmet needs, is progressing according to plan, and we anticipate a beta launch of 3P HIP. Once launched, 3P HIP will spawn further sharetaking opportunities for us within the plating franchise. Overall, T&D continues to be a solid performer for us as we leverage our scale, capture market share, and bring new products to market that fill unmet needs and drive continued growth across the board. As for the non-surgical specialty bracing business, our OPSB, from the start, we have been very bullish about this franchise, which represents a large new source of capital-friendly growth. Following the successful integration of 3P and 3P, we are very pleased to see our strategic rationale validated and playing out as we expected, maybe even better than we expect. As previously announced, we expanded our clinic business through both Greenfield expansion in Indianapolis and aqua-hire in Florida and Colorado. The opportunities for clinic expansion are immense. The demand from our customers is high, and our funnel for clinic expansion is very large. The stand-up of the early expansion clinics is going well in providing a reproducible playbook that represents a substantial growth lever with significant runway. We are pleased with how we are tracking to our guidance for four new territories in 2025 and expect that there will be more updates on this front throughout the year. On the product side of OPSB and as previously mentioned, we are experiencing rapid growth of our DF2 femur fracture brace, which is growing so rapidly that we are seeking additional manufacturing sources so that we can meet current and future demand. Beyond that, our OPSB R&D team launched multiple products such as a new scoliosis brace sensor with patient compliance software and additional DF2 sizes as we extend its use beyond fracture management. And we signed distribution and licensing agreements for the Move D brace to minimize tremors developed at Children's Hospital of Orange County and the Thrive product portfolio including Thrive Orthopedics F3 Hero pediatric AFO, the True Stretch pediatric Aquinas brace and the Thrive pediatric X-Glide carbon fiber insole, all focused on three unique pediatric orthotic conditions. These solutions are more evident supporting our thesis that OPSB can become the clearinghouse for specialty bracing products specifically designed for kids. Further, the pipeline of new opportunities coming on the business development side of OPSB is really ramping. We are certainly attracting entrepreneurs and inventors with new product lines and technologies that they desire to scale globally through our growing sales channel and clinic network. This is coming in licensing, distributing, and in some cases small acquisition opportunities that will continue to allow us to leverage our channel, thus growing revenue and adding profit. We are building a new market for us. We do have 5 years of growing conditions between sand Exactlyer Wices and how that affects the field and the long term shared goal basically creativity, Any connection to hope and the future of the better norm Is that we're going to be really Shaktik-eating it's going to be really important to get to that high level of discovery from business. Our strong growth seen in Scoliosis this quarter was driven by continued share gain combined with new users from large accounts. We anticipate that this trend will continue into 2025. As we increase our volume, we expect to reap the benefits of the new user acceleration from late 2024. To highlight a few key products, we continue to see strong growth in our Response Fusion franchise from new customer acquisition. We saw additional 70 placements in the fourth quarter in large institutions and the continued introduction of our first EOS product, Response Ribbon Health. We have a substantial opportunity to grow Scoliosis revenue over the next three to five years. Additionally, we are seeing a consistent stream of new Apithix users and growth that only continues to pick up. More users are learning where Apithix fits in their treatment algorithm. This supports our vision that eventually Apithix will be a tool used by almost every pediatric Scoliosis surgeon. While still relatively small, we expect Apithix to continue to grow rapidly in 2025 as more surgeons better understand the best use case for the advice in their practices. Looking at our EOS products, our EOS product portfolio development remains on track and we are directly discussing the requirements for product approvals for ELLI and Vertiglide with the FDA. We have been working on confirming the regulatory path and recently we've had encouraging feedback from the FDA. The most recent discussion have led us to believe that there is a higher likelihood that Vertiglide will be approved in the U.S. sooner than expected and under 510K clearance. Moving on to International. In the quarter, we saw slower international sales generating revenue of $9.8 million and delivering 5% growth year over year. Despite significant international demand, we made a conscious decision to limit additional stocking order shipments to certain stocking triviers in order to stimulate timely receivables collection which have been negatively affected by the rising dollar against South American currency. Trauma and deformity implants were most affected by the shipping holes in South America while Scoliosis delivered very nice growth year over year. That said, general demand across the entire TND and Scoliosis portfolio was healthy, especially in our agency market where we saw strong sales growth. In fact, non-LATAM TND growth exceeded 20% and Scoliosis grew nearly 30%, highlighting the extremely compelling underlying demand. International Scoliosis performed well due to solid revenue in our direct markets where we are seeing new users come on board. We are very happy with the progress made in 2024 launching the Scoliosis business in the EU and expect that with the anticipated EU MDR approvals, our EU Spine franchise is set for high growth in the future. As we look ahead, EU MDR approval remains a large catalyst for our growth in 2025 and beyond and we are confident that we are well positioned for approvals. We are awaiting the notified body audit to finalize our EU MDR status which we expect to be completed in mid 2025 and once we receive our first, we will launch a wave of products into the EU and then expect additional ways as further approvals are accomplished over the next 18 months. I want to point out the EU MDR approval for implants is an expensive process, but we believe it is the right thing to do for kids who need these devices outside of the United States and it strengthens our strategic position. Additionally, we are exploring further expansion opportunities for OPSB outside the US in 2025, which comes with a light touch and quick turnaround when it comes to regulatory approvals. Overall, the international business is set up nicely and we believe the remainder of the year will contribute toward a healthy 2025. Finally, this brings us to surgeon training and education. In the fourth quarter, we hosted 132 unique training experiences for over 2,700 healthcare professionals, including during IPOS, the International Pediatric Orthopedic Symposium, where orthopediatrics continued our leadership position as an emerald-level sponsor. Once again, our team was well represented and connected with customers to share hands-on learning experiences with our new and innovative products. We were excited that through our booths and our educational events, we were able to introduce our new enabling technology division as well as highlight all the great work we are doing in non-operative care through OP specialty embracing. Our time at events like this is incredibly important as we prioritize providing clinical education opportunities to grow alongside the pediatric orthopedic community. So 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 more details on our financial results, I wanted to reiterate that through our continued execution, we have established orthopediatrics as a high-quality and differentiated asset with the demonstrated ability to scale growth, increase operating leverage, which provides a clear path to free cash positivity, and we are supported by a very strong balance sheet. That said, we made some very difficult, yet very strategic decisions in the quarter that we expect to support our commitment to growth, profitability, and improved cash usage. You will notice some one-time charges on the P&L. The $3.7 million restructuring charge is primarily due to the closure of our OP Israel office, which was the former Appifex headquarters. We have decided to move production out of Israel and into the U.S. to reduce supply risk and to consolidate the management of the Appifex product line into our Warsaw operations. These difficult decisions are a component of our continued focus on delivering improved, and demonstrate that adjusted EBITDA improvements and reduced cash usage are top priorities for the company. Additionally, as you will see from our results during the quarter, our gross profit margin profile has shifted slightly. As we continue to integrate Boston O&P, we are growing the OPSB business, launching this new strategy, and working through the process, we are learning and have adjusted certain expenses out of general and administrative expenses into cost of goods sold. As a result, we saw a negative impact on the gross margin profile of OPSB and our overall gross margin for the quarter. I wanted to be clear, this does not impact our profitability, and giving our growing channel in OPSB, we will not shun lower gross margin distribution opportunities that leverage our fixed costs and improve overall profitability. We've made a full year adjustment of approximately three million dollars out of G&A and into cost of goods sold. This negatively impacted our fourth quarter gross margin, but properly reflects our full year 2024 gross margin. Taking a closer look at the P&L, our fourth quarter 2024 worldwide revenue of 52.7 million dollars increased 40% compared to the fourth quarter of 2023. Growth in the quarter was driven primarily by strong performances across trauma and deformity, scoliosis, and OPSB, as well as the addition of Boston O&P, slightly offset by the lower growth in the international revenues. US revenue was 42.9 million dollars, a 52% increase from the fourth quarter of 2023, representing 79% of our total revenue. Growth in the quarter was primarily driven by our additional market share gains across trauma, deformity, scoliosis, and OPSB, as well as the addition of Boston O&P. We generated total international revenue of 9.8 million dollars, representing growth of 5% compared to the fourth quarter of 2023, representing 21% of our total revenue. Growth in the quarter was primarily led by strong scoliosis sales in our agency markets. In the fourth quarter of 2024, trauma and deformity global revenue of 36.4 million dollars increased 35% compared to the prior year period. Growth was primarily driven by PEGA products, trauma, x-fix, and OPSB, plus the addition of Boston O&P. In the fourth quarter of 2024, scoliosis global revenue of 15.6 million dollars increased 62% compared to the prior year period. Growth was primarily driven by increased U.S. growth across the response and a pfix non-fusion system, an additional impact from 7D, as well as the addition of Boston O&P. Finally, sports medicine other revenue in the fourth quarter of 2024 was 0.6 million dollars compared to 0.9 million dollars in the prior year period. Turning to set deployment, 3.7 million dollars of sets were consigned in the fourth quarter of 2024 compared to 5.9 million dollars in the fourth quarter of 2023. In 2024, we deployed 21.1 million dollars of sets compared to 22.0 million dollars in 2023. The 21.1 million dollars for 2024 was slightly higher than our forecast of less than 20 million, driven by higher than expected 7D placements and some earlier than expected deliveries on some recent product launches. Touching briefly on a few key metrics, for the fourth quarter of 2024, gross profit margin was 68% compared to 71% for the fourth quarter of 2023. The decrease in gross profit margin was primarily driven by an approximately three million dollar full year adjustment from the related to manufacturing across the OPSB business. Full year 2024 gross margin of .6% is a better representation of the business's performance and is more indicative of the gross margin rate for the near future. Total operating expenses increased 14.8 million dollars or 43% compared to the prior year period to 49.6 million dollars for the fourth quarter of 2024. The increase was primarily driven by the restructuring charge, the impairment charge, the addition of Boston O&P, increases in spending related to EU MDR compliance, increased commission expense, and the incremental personnel required to support the ongoing growth of the company. Sales and marketing expenses increased 4.0 million dollars or 31% compared the prior year period to 16.8 million dollars in the fourth quarter of 2024. The increase was mainly driven by increased sales and commission expense. General and administrative expenses increased 5.4 million dollars or 28% year over year to 24.4 million dollars in the fourth quarter of 2024. The fourth quarter increase was driven primarily by the addition of personnel and resources to support the continued expansion of the business and an increase in depreciation and amortization. Research and development expenses remained flat at 2.9 million dollars in the fourth quarter of 2024 due to the timing of external development expenses. As discussed, in the fourth quarter we did see the impact from the one-time charge of 3.7 million dollar restructuring charge that includes severance, inventory write-off, lease break, and other expenses associated with the closure of our Israel office. In addition, we recorded a charge related to one of our trade names of 1.8 million dollars. The other expense was 2.4 million dollars for the fourth quarter of 2024 compared to 1.2 million dollars of other income for the same period last year. Adjusted EBITDA was 3.0 million dollars in the fourth quarter of 2024, more than doubled when compared to the 1.3 million dollars for the fourth quarter of 2023. For the full year of 2024, adjusted EBITDA was 8.5 million dollars compared to 5.0 million dollars in the prior year. In the fourth quarter of 2024, free cash flow usage was 3.7 million dollars, representing a significant reduction of 70% when compared to the -to-date average through the first three quarters of 2024 and a 67% reduction when compared to the same period in the prior year. We now expect the first quarter of positive free cash flow to be in the fourth quarter with 70.8 million dollars in cash, short-term investments and restricted cash, and we still have 25 million dollars available on our new term loans. Turning to guidance, we are reiterating our expectation for full year 2025 revenue to be in the range of 235 to 242 million dollars, representing -over-year growth of 15 to 18%. During our analyst day last September, I had communicated that we expect our gross margins to remain flat at 74 to 75% for the next several years. Given our current reclassification of G&A into cost of goods sold, I am restating the that our gross margins will in fact continue to be flat. However, the newly updated range is 72 to 73%. This does not impact our profitability, just the buckets within the P&L. We also continue to expect to generate between 15 to 17 million dollars of adjusted EBITDA in 2025. Additionally, we continue to expect approximately 15 million dollars of new sets deployed in 2025. This represents our continued focus on driving the business to free cash flow break even by 2026, and we anticipate delivering our first quarter of free cash flow positivity in the fourth quarter of 2025. Our current guidance assumes no impact of tariffs or other government changes. However, we will continue to monitor the dynamics, and while we expect potential tariffs to be minimal impact, it is too early to determine all potential government actions and their impact. I'll now turn the call back to Dave for closing remarks. Thanks,

Fred. We are encouraged by how we ended the year and have already seen that momentum begin to carry into 2025. Our success in 2025 and beyond is driven by three main factors, execution and scaling of OPSD, share taking across the business by leveraging prior set deployment, and ongoing success of our innovative product launches. The aggressive approach we have taken to this business and the opportunity ahead of us over the next three to five years is very exciting. We are extremely proud that we've continued delivering strong performances, especially within this medtech market, quarter over quarter and year over year, and we do not plan for this to change moving forward. We will continue to help more children than ever, capture more share across the entire business as we continue to break revenue records, grow our adjusted EBITDA, and improve cash usage in 2025 and beyond. Operator, let's open the call for Q&A. Thank you.

Thank you so much. And as a reminder to our audience to ask a question, simply press star 11 on your telephone and wait for your name to be announced. To remove yourself, press star 11 again. Our first question is from Ryan Zimmerman with BTIG. Please proceed.

Thanks for taking our questions, guys. Appreciate it.

I'll

start with guidance a little bit. I know you don't guide by segment, but maybe you could help us kind of how you're thinking about some of the contributions here in each of the buckets of the businesses. It sounds like certainly the OUS business with the addition of EU MDR clearance could step up a little bit in 25. I'd appreciate any call you have there. And then I'll ask the second question up front too, which is just around seasonality and pacing through the year. I mean, we know kids tend to get their surgeries, second quarter, third quarter, in the summer in between school. But you've had some fluctuations, I guess, between the fourth quarter, the first quarter due to seasonal dynamics, flu, RSV, et cetera. So any call there, I think, would certainly be appreciated as well. Thanks for taking the questions, guys.

Thanks, Ryan. So I think from a seasonal perspective, maybe I'll take this one first. I think that likely to see consistency, the consistent seasonality of the business, the way we've seen in the past with kind of June, July, August still being our biggest months. December, obviously a big month for us as well as school as kids get out. It is possible that over the course of the next several years as OPSB continues to grow, that some of that seasonality could maybe level out a little bit. But I think that normally see our first quarter as light step down from Q4 of the previous year. And then we scale into Q2 and Q3 as the summer season continues to grow. I think you're spot on in terms of the impact that EU MDR can have on the business. It's not a panacea right away. Obviously, we've got to get sets built and we've got to get sets sold to distributors and sets into the market when we get approved. But certainly it should have a positive impact in 2025 and probably more of an impact even in 2026 and 2027. I think the thing to call out there is that we're seeing really strong growth of our Scoliosis franchise in Europe. And that's really with only one of the systems available. So our 5560 response fusion system. So as we can bring a full product portfolio to Europe on the fusion side, I think we're going to continue to see that business grow. And that starts to negate some of the reliance that we've historically had on Scoliosis OUS in Brazil and some of the South American markets, where it's primarily been our larger opportunities outside of the United States up until recently. As you think about trauma, deformity and Scoliosis here in the United States and I guess around the world. Generally speaking, as you said, we don't generally guide specifically there. But I think you could expect to see Scoliosis smaller business continue to grow a little bit faster than the trauma and deformity business. Obviously, much larger business on the TND side and greater market share. And I think that's probably what you'll see again here in 2025.

Okay, very helpful, Dave. Appreciate the call. I'll hop back in queue. Sounds

good.

Thank you. Our next question comes from the line of Rick Weiss with Stiefel. Please proceed.

Good afternoon, Dave. Hi, Fred. So much to unpack here. It's intriguing. Maybe talking about a couple other opportunities. It seems like the business has tremendous momentum as you're talking about. Then the US numbers would just be the same as you suggest. But maybe start with OPSB. You're saying strategic rationale playing out. The funnel is full, four new territories. Help us think through, talk through it maybe a little more detailed, Dave, the pipeline, new opportunities, the licensing. How's that? What have you assumed in 2025? How do we translate that into thinking about growth or outlook or time of year? Or do we see it in 2025? Just help us think through that opportunity.

Sure. Good question, Rick. So obviously, when I talk about the three main things that we have to do to continue to really grow the business 2025 and beyond, scaling OPSB at the top of that list. This time last year, we had just completed the acquisition of Boston. We're just really starting the journey of scaling OPSB. When I look at that now a year later, I think everything we thought Boston could be and the scaling of clinics and the addition of products has come true. We're looking at a $500 million TAM that's easily accessible with less capital, frankly, than the consignment model of our implant business. That was the thesis that we could scale into this. I think we have throughout the year and I think it's going to be a big part of 2025 and beyond. What we've learned, I guess, and our customers are certainly interested in more clinics, more products. It's clearly a very underserved segment of the pediatric orthopedic marketplace. It has a ton of synergies with our implant business. I think that the implant business is in part growing because the OPSB franchise is growing and the brand of orthopediatrics and its importance in the mind of our customers is growing as well. I guess when you think about clinics, our aspiration is to have four new territories, as we call out in the analyst day, and we're sticking to that. It does seem like we've got enough in the funnel that it's possible that we could go to more than four territories in 2025. We're not calling that out, but it is possible. We certainly won't hold back in terms of our opportunity to expand beyond those four territories. What we're really saying is coming out of the analyst day in September, I think we're much, much more solid on the pace with which we can scale our OPSB clinics and have a better sense of what the cost associated with that is to the P&L. We've now set up some greenfield clinics, some of the first ones we've ever done. Those greenfield clinics and that process was, I would say, in line with the timing and the cost that we thought. That's encouraging. Then, I guess last, the specialty bracing business and the R&D side of there and these licensing opportunities and distribution opportunities, it's really powerful. We think of this business as an opportunity for us to establish what really is a single channel, almost dare I say an Amazon of pediatric orthopedic non-surgical devices, where if entrepreneurs and small companies want to access the pediatric orthopedic market and access our customers, there would be an opportunity to do that through the scale that we enjoy here in the United States and then around the world. Then, as we add more clinics, you fast forward this several years where we would say we have a completely dominant position in clinics, that becomes an even more powerful type of channel for us to drive revenue through. Then, I guess the last thing, sorry, long answer to a short question, Rick, but we're seeing devices like DF2, which you heard called out in the script, growing at rates that I'm not sure we thought were, we're very encouraged, I guess, by the way DF2 is growing. We see a number of opportunities like DF2 to continue to grow. Again, that has a duplicate of effect when you're not only selling it to the hospitals, but then as we add clinics, we're selling it through our own channel. Hope that answered your question, but a lot of optimism, obviously, and very encouraged a year post-OPSD, a year post-Boston, what we can do with that over the next several years.

Yeah, that's great. Thanks for all the detail. Fred, turning to gross margin again, I totally get what you're saying. The first thing I looked at was to see whether your adjusted EBITDA would change. I see it's unchanged, so I get it. But help me understand, you had said the 74, 75 range before you made this adjustment was flat. You said it again tonight. But it just strikes me, with all these new products launching, your gain share, and I reflect on the Israeli closure, I get the reasons for doing it. Wouldn't that be positive as you consolidate manufacturing and run more volume through Warsaw? I guess my real question is help us think through some of the margin, or whatever you want to say. Is there room for upside as we go through the year, European products are approved? It just seems like there is room for upside as we head toward the end of the year and maybe start thinking about 26. Thank you.

Yeah, thanks, Rick. Great question. I would say we are hesitant to get ahead of ourselves, but we do agree that there may be some opportunities that we're working on in that area. As we've talked in the past, a little bit of selling price always helps in that area, and so we'll continue that trend. There is some consolidation, which could help show up as favorable gross margin. Then there's some other activities that we are, I think, refocused on this year that maybe we haven't been as focused on in the past that could definitely over the next several years have a favorable impact on the gross margin rate. I think we're being conservative, keeping our guidance flat as it was before, but I would say we have a renewed focus in this area to make some improvements there.

Sorry, Fred, you teased me. I got to ask, other activities help me understand. Thank you.

We're reviewing all of the line items.

We're

reviewing all of the line items that go into our cost of goods sold and looking for opportunities to leverage that, just like we're leveraging the SG&A down below. Gotcha. Thank you. Thanks,

Rick. Thank you. Our next question comes on the line of Matthew O'Brien with Piper Sandler. Please proceed.

Good evening. Thanks for taking my questions. Maybe to follow up on Rick's question on OPSD, did you guys, I think you mentioned doing better than 25 million in sales in 2024. Did you do that? Are we still expecting north of 20% growth out of that business here in 25? Then just a little bit more specifics on things are going better than expected. Dave, is it really just going deeper in the existing facilities that you have or just that you're ramping the new ones faster than you expected? I don't know if it's cost or something else, but just any kind of detail there would be helpful and then I do have a follow-up.

Yeah, perfect. I think it's safe to say that OPSD across the board, not just Boston, but OPSD across the board, MDO, DF2, the products associated with that, or a medical, as well as the clinic expansion is growing rapidly. Yes, I think it will definitely be growing north of 20% in 2025. We see that growing north of 20% for a long time, frankly. We got a long way to go as we scale that business. I think when we see things going better than expected, the volume of opportunities for clinic expansion is extremely high. It takes time. Some of those, as we said, are going to be acquihires where we've got to get a footprint in a big market that we have no clinics in currently, but the opportunities and profitable opportunities for us are very high and surgeon demand for that service, as well as the products, is very high. Again, we thought that was what we were going to see when we announced this acquisition a year ago. At this stage, I would say the demand for what we are offering is higher than I would have expected at this time. Then devices like DF2 are going better than we expected. I see the demand for that product as very high. We're now seeking alternative manufacturing sources. We make it in our facility in Boston, and we're going to have to continue to be able to scale the manufacturing of it there in Boston, as well as probably through other facilities. We have, I want to say, 30 plus countries now that the DF2 product is approved. The thesis that we can get these products approved outside of the United States, much faster than our implant products, and that there is huge demand outside of the United States, is certainly an accurate thesis. We've got to be able to scale manufacturing of those devices such that we can meet demand outside of the US. I can just say that the surgeon demand for that device here in the US, again, still small, but maybe greater than we would expect. We have several more devices that I'm not saying are all home runs like that one, but several more devices on the R&D side that we're close to launching, working with a number of surgeons on. I would think that you're going to see similar kinds of impact from those devices on the OPSB business overall.

Okay. That's, I guess, a good problem to have on the manufacturing side. Then question for Fred, just as I look at the instrument set deployments that you've done over the last couple of years, I think it was 23 and then 20, and now we're down to 15. I know you have a more capital-efficient model now with OPSB, but the legacy trauma and spine businesses are doing really well. Are you going to run the risk of starving those businesses a little bit in the near term, and we're going to need another big bump as far as set deployments go in 26, 27, or is this more of a steady state in terms of how much you really need to be deploying in order to grow the businesses still at a very healthy clip?

Yeah, it's a great question. It's a question we spend time analyzing ourselves. We think 15 is the right number for 20, 26. I think the good news is a higher percentage of that is really for new products as opposed to legacy products, so we're really excited about that and the impact that that's going to have on our overall business and growth in 27 and beyond. In 20, 27, what is the demand for legacy systems as well as new products? Again, I would expect 26 and 27 to be highly concentrated on the new product launches given all the launches coming up that we have in 25, 26, and 27. I would say that we haven't made that determination yet, but we will be confident in saying that it's going to be highly focused on our new products being launched.

Yeah, I think it's safe to say we're not going to starve those businesses, particularly when we see products like PMP Tibia that have relatively high ASPs, fantastic margin. I mean, the business that product line, I think we told you, we achieved this year's revenue in May, so those that device is obviously growing, and we're going to support that. I think what we've seen over the story well, but when we were deploying $3 to $5 million worth of inventory for several years, primarily legacy products, we've probably entered near the end of the need to deploy a lot of those legacy products. As Fred said, these are primarily new product development, and the numbers will shift as we have really compelling new products like PMP Tibia and some of the other devices. When you also think about the out years of our growth, particularly on the Scoli side, certainly a new Scoliosis system coming soon that we've talked about, but also EOS products. EOS products, as you know, very high ASP. They're all scheduled procedures. We're fighting tooth and nail on the regulatory side, but when you get through that, these aren't set deployment needs that are massive for us to be able to grow our top line, particularly on the Scoliosis side and with these highly differentiated trauma implants. I think that's what you're seeing with the move down a little bit on the implant side of deployment. Again, as demand dictates for some of these more differentiated products, that'll change from time to time, but I think we're going to be able to sweat our assets in a way that's going to allow us to not have to deploy as much in the future.

Very helpful. Thank

you.

Thank you. Our next question is from the line of Mike Mattson with Needham & Company. Please proceed.

Hey guys, it's Joseph Ahn from Mike. Thanks for taking our questions. Maybe to start it off, just wanted to see if we could get an update. I guess the first one on Playbook, the enabling technology software. Just kind of curious how that business is going, any milestones there? And then the new fusion implant system, is that still on track to launch in the second half of this year?

Yeah, good question. So Playbook was, I think, officially launched to the sales team at our sales meeting here about a month ago. And so the device, the product is, we're very pleased with the way the product looks. And certainly it's a process to get those products implemented inside hospital systems. But I think we've made really nice progress on Playbook on the enabling tech side. And just from a revenue perspective, it's a business that we haven't forecasted a ton of revenue in 2025. We see that as contributing to driving revenue in our trauma deformity business and in our scoliosis business. And then driving more substantial revenue as a standalone play in 2026, 2027 and beyond. But extremely pleased with where it's at. And it created a heck of a lot of buzz at our sales meeting, which was very encouraging. And on fusion? Oh, on a fusion side, yeah. The fusion, product development on track. And I think the goal would be to try to get some surgeries done by the end of 2025 here in the United States. But again, not something that we have placed in the 2025 forecast in terms of revenue. And so we're going to make certain that we get the device right. And it's everything we want it to be. The fusion business as it stands with response is growing very rapidly now. So we don't have to rush things certainly to get that device on the market.

Okay, great. And then maybe just one more on 7D. It seems like, you know, three Q in this quarter, four Q were pretty strong. It seems like that's ramping up. I guess just looking at 2025, do you guys kind of see this as more of an inflection for 7D placements? Or is it maybe just a little longer, maybe 2026, that it's more meaningful driver?

Well, I think 7D is a driver right now, was a driver for us in the second half of the year. So you're seeing a response fusion business and just our Scoliosis business, particularly in the United States, accelerating growth on a much larger business. And again, that's one of the reasons why while we want to get the new system out, we're driving a heck of a lot of growth with existing system in conjunction with 7D. So I think we're already starting to see the impact of that as we've placed 7D units in accounts that historically haven't been large users of our fusion products. And so that's impacting Q3, Q4 revenue. And in fact, we'll have a pretty substantial impact. And I think why you see us so confident in our growth on the Scoliosis side in 2025 and 2026, because a lot of that is connected to 7D placements. I think we've learned a lot about just capital placement in general. As you know, just a few years ago, we had no experience in this space. And so our capacity to build a funnel and to see these things come through the funnel in a more consistent way, quarter to quarter to quarter, I think that's a muscle that we have built. And I guess I have to credit the Enabling Technologies team that while we're also working on Playbook and technologies like that, it's been a huge help to us to be able to develop the muscle to get involved in capital placement and capital equipment sales. And so I think you're going to see in 2025, consistent placements quarter to quarter to quarter of 7D units that will impact revenue on the Scoliosis side, both in 2025 and for the next three years. So it becomes a bit of a compounding effect as we place more and more of these units.

Okay, perfect. Much appreciated. Congrats on the great quarter. Thanks.

Thank you. And we have a question from Ryan Zimmerman from BTIG. Please proceed.

It's just a high level question followed for me, Dave, for you. You know, there's just been a lot of chatter about Medicaid coverage in the news lately, right? And potentially removing that. I think as I think about CHIPS and Medicaid, I think it covers something like 37 million kids in the US. And so, you know, I don't know what your thought is on it if you have a thought. But, you know, I have to imagine your customers are thinking about it, how they're thinking about positioning for it, and how you think about it in terms of, you know, potentially impacting the business. I just wanted to kind of, you know, pick your brain on it a little bit, if I could.

Yeah, well, certainly not a topic that anyone can give you a definitive answer on, as you know. But, you know, it's obviously something we're watching. You know, I'm not sure exactly how that impacts the business as we go forward. Obviously, we're not certain that it is going to impact it at all. That said, I think our feeling here is that we really struggle with the concept that children will be left without any form of healthcare. And if you look at the makeup of customer base, so much of our customers are currently in systems where, you know, they're endowed hospitals or they're hospitals like the Shriners hospitals, for example, that certainly take what Medicaid or private insurance might pay, but are still offering care based on their endowments. So, I think there is some shielding that we would have of that. And I think when push comes to show that seems very difficult that we are going to, you know, allow kids in this country who have cerebral palsy or congenital deformities to not have appropriate access to the kinds of devices that they need in the hospital to live a normal life. And I think, you know, all of our devices have a very, very rational impact on the total cost of care, right? And so, if we can impact positively these patients in the operating room that then ultimately lowers their care to Medicaid thereafter, again, it's hard to imagine that those devices wouldn't be readily available to our customers. But again, it's anybody's guess at this stage. And we have not, we can't formulate exactly, you know, what potential impact here. But I think it's, I guess we aren't betting that this is a major impact on our business on a go-forward basis.

Yeah, no, makes sense. And I appreciate your thoughts on it,

Dave. Thank you. And this concludes our Q&A session for today. I will turn it back to Dave Bailey for final comments.

Great. Thanks, operator. And thank you, everybody who joined our call this evening. And appreciate your questions. And we'll look forward to giving you a business update in the coming quarter. Have a great evening.

And thank you all for participating. And you may now disconnect.