KIDS - NASDAQ

Good day and thank you for standing by. Welcome to the OrthoPediatrics Corporation First Quarter 2025 Earnings Conference call. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question and answer session. [Operator Instructions]. Please be advised that today's conference is being recorded. I would like to hand the conference over to your first speaker today, Trip Taylor, Investor of Relations. 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 discussion of risk factors, I encourage you to review the company's upcoming quarterly report on Form 10-Q, which will be filed with the SEC on May 8, 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 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, May 7, 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 would like to turn the call over to David Bailey, President and Chief Executive Officer.

Thanks, Trip. Good afternoon, everyone, and thank you for joining us on our first quarter 2025 conference call. As always, I want to begin by highlighting the metric that best represents our ongoing success and the one we are most proud of. In the first quarter alone, we supported the treatment of nearly 39,000 children, bringing our total impact to over 1.175 million kids helped since our inception. For too long, pediatric healthcare providers have had to rely on inadequate solutions, and we remain steadfast in our mission to change that for the better. Our ability to execute on our commitments, our consistent track record of sales growth through sharetaking, as well as deliberate step function improvements in adjusted EBITDA and cash usage are just a few small aspects of what continues to set us apart and enable us to maintain our position as the clear-cut market leader in pediatric orthopedics. These capabilities were on full display throughout another strong first quarter, underscored by solid performances and revenue growth, improved profitability, and reduced cash usage. Our success in 2025 and beyond will be driven by three main factors, executing and scaling of OPSB, sharetaking across the surgical business by leveraging prior set deployment, and ongoing success of our innovative product launches. Our global revenue growth of 17% is a result of executing in each of these areas. Our efforts to scale OPSB are advancing steadily. Execution of the OPSB strategy and further clinic expansion is on track and driving total OPSB growth of better than 20%. We're gaining market share in the surgical segment by strategically leveraging previously deployed sets. It is particularly gratifying to see growing utilization from previous set deployments along with continued search and adoption of key product launches such as PMP femur, PMP tibia, cannulated screws, and DF2. During the first quarter of 2025, we were very excited to receive final FDA approval for the Verteglide system, sterile PNP femur, sterile PNP tibia, as well as Orthex titanium half pin. In late April, we received a much anticipated approval for the 3P pediatric plating platform HIP system. This brings our total FDA approvals for the year to five and includes two major systems. Additionally, search and adoption of our response fusion system continues to grow, which is being positively impacted by past 7D placements and would be bolstered by additional unit deployments that happened in the first quarter. And we will continue to benefit from 7D placements throughout the year. All-in-all, we are very pleased with the way things are progressing on the revenue front and remain bullish about the year. Beyond revenue, we improved profitability and reduced cash usage. Our adjusted EBITDA loss was reduced by more than half year-over-year, while we improved free cash flow by 36%. We remain on track to meet our adjusted EBITDA goals, which will fully pay for our 2025 set deployments and lead to positive free cash flow in the fourth quarter of this year and full year free cash flow break even in 2026. Additionally, we expect cash usage will improve materially in the second half of 2025, which will result in very little cash usage in H2. While we continue to prioritize growth, the efforts we have been making to improve profitability and free cash flow are clearly working, proving we are quickly becoming a high growth med tech asset that will be solidly profitable and generating cash from operations. This is a difficult transition for early stage companies to navigate, and I am proud of the work our entire team is doing to make it happen. Regarding tariffs and the broader macroeconomic environment, OrthoPediatrics has minimal exposure to tariff related impacts. We estimate that approximately 95% of our cost of goods sold come from domestic suppliers and our Canadian entity, which is currently exempt from tariffs. Even under the worst case scenarios contemplated in recent months, any potential impact would be minimal and would be absorbed within our current guidance. Additionally, reciprocal tariffs, real or potential, are unlikely to materially impact revenue, especially given that we do not sell any products in China. Also, it is very important to reiterate that most of our procedures our customers perform are non-elected and are often carried out in hospitals supported by substantial endowments, which have historically helped shield us from the effects of economic downturns. Over 20% of our global revenue is trauma related, which is clearly non-elected. With a U.S.-based manufacturing and supply chain backbone and the largely non-elective nature of our procedures, we are positioned to sustain our growth and profitability trajectories regardless of broader economic conditions. With that said, we expect our business to gain momentum throughout 2025 based on our success scaling OPSB, driving market share gains through leveraging existing set deployments, and the ongoing success of our innovative product launches. As such, we are increasing our full year revenue guidance. We now expect to generate revenue of $236 million to $242 million, representing annual growth of 15% to 18%. We still expect to generate adjusted EBITDA of $15 to $17 million, which will be greater than the $15 million of sets we plan to deploy in 2025. We also continue to expect our first quarter of positive free cash flow in the fourth quarter of 2025. In the first quarter of 2025, the T&D business grew 14% as we continued to deliver strong market share gains across multiple product lines, bolstered by strong growth of OPSB. Growth in the quarter was extremely strong in the U.S. and offset by softness in LATAM and lower OUS set sales, which contribute little to profitability. The quarter's performance was driven by prior investments in set allocation, surge in education, and new product adoption, resulting in strong share gains for T&D across the breadth of products. In 2023 and in 2024, we had sizable set deployments. As a result, the usage of prior set deployments is increasing and contributing to growth in meaningful ways. In the quarter, we saw very strong revenue growth of trauma products, led by rapid adoption of PNP Tibia and cannulated screws and DF2. Additionally, we launched several sets of PNP Tibia, with more expected to launch in the second quarter, as PNP Tibia will continue to be a solid growth driver for the next several quarters, if not several years. Once again, DF2 continues to exceed our expectation as demand accelerates and we are seeing rapid surge in adoption. This product is differentiated within the pediatric femur fracture management, is benefiting from expanded indications for use, and is quickly becoming the new gold standard of care. As of today, we have achieved approval for this product in 33 countries internationally, within just a few months, and we're just starting to sell in many of these countries, so we are very early in this successful launch. Further, we are pleased to report that we have mended the short-term supply issues and are now working on several longer-term solutions. On the R&D front, as you may have seen in our recent press release, we are proud to announce that we have received FDA approval for our 3P pediatric plating platform, hip system. With this approval, the 2025 beta launch of the first 3P system, 3P hip, will begin in earnest this summer, and we look forward to providing more updates as that product is launched and rolled out. As a reminder, 3P hip is the first of several systems in a long line of coming product launches from the new 3P family, and will result in a complete transformation of our plate and screw product portfolio, giving us the most robust and modern plating portfolio in pediatric orthopedic history. Additionally, we are continuing the process of EU MDR compliance and expect to launch new products into Europe, starting in the second half of 2025, followed by more next year. Overall, T&D remains a strong contributor to our performance as we capitalize on our scale, expand market share, and introduce innovative products that address unmet needs and support sustained growth across all areas. Our path to market share dominance within T&D is clear. On our non-surgical specialty bracing business, or OPSB, the further we progress our strategy and the more the pieces of the business come together, the more encouraged we are by the opportunity and support we are seeing for this franchise. OPSB represents a large new source of capital-friendly growth that we plan to capitalize on through territory expansion, R&D acceleration, and scaling our sales channel and sales force. Most notably, on the territory expansion side, we have hit our initial guidance for 2025. We have now entered North Carolina, our fourth territory, in 2025. As we've previously discussed, not every territory or clinic will be equivalent, and their size, ramps, and impacts will vary. So while we are pleased with the pace with which we have been able to achieve this territory expansion, the North Carolina Clinic is currently a smaller but strategically important opportunity, and we want to take that into account when we look at our overall goals for 2025. With that being said, we believe there is potential to add additional territories in the second half of 2025. The opportunities for clinic expansion are immense. The demand for our customers is high, and our funnel for clinic expansion is very large. Notably, we are in very early discussions on multiple opportunities for OPSB internationally. When we first looked into OPSB territories, our initial focus was on the U.S. and getting the ball rolling here. The early expansion clinics in the U.S. are progressing well, and we are creating a repeatable playbook that serves as a strong growth driver with considerable long-term potential. So we are looking at various ways to bring OPSB to international markets. Importantly, the international markets are not included in our $500 million TAM, so these clinics would offer an opportunity for TAM expansion. We're pleased with our progress toward the launch of four new territories and anticipating sharing further updates as the year unfolds. On the OPSB R&D side, in the first quarter, we launched two distributed product lines, including Thrive carbon fiber braces and UNFO metatarsus adductus brace through OPSB. These product lines complement our existing OPSB portfolio and expand options available within the OPSB clinic. Moving to the scoliosis business, our strong growth of 34% seen in scoliosis this quarter was driven by more sharetaking, both in the US and OUS markets, with increasing demand from new markets in the EU. US scoliosis growth was very strong due to 7D placements and new users adopting OrthoPediatrics technology, including Apifix, Response, as well as our commitment to new solutions for EOS patients. We saw healthy 7D unit placements in the first quarter and anticipate more to come throughout 2025. OPSB 3D patient-specific scoliosis braces also contributed to the strong growth. International scoliosis was strong due to solid revenue in our direct markets, including Canada and Australia, where we are seeing new users come on board. We are very happy with the progress made in 2024, and it continues through the first quarter. The coming EU MDR approvals will further positively impact our EU Spine franchise. As we've discussed since our Analyst Day last year, our scoliosis portfolio is rapidly evolving to meet all the needs of our customers. Recently, our EOS product portfolio took a massive step forward with the FDA approval of Verteglide in the first quarter. We expect the first cases to be completed in the coming weeks, and we are already seeing requests from customers at large U.S. accounts where we historically have had little scoliosis revenue. eLLi, our mechanical growing spine implant product development, continues to move forward, and we are having frequent positive interactions with the FDA. At this point, our goal is to make an eLLi regulatory submission in late 2025 or early 2026. With response ribbon pelvic launched, Verteglide FDA approved, and eLLi progressing, we have a clear line of sight to having far and away the most robust set of EOS solutions available for our customers to treat this very complex patient population. And that fact alone is driving more adoption of our total scoliosis offerings. Moving on to international. While we saw double digit growth internationally, our strength was again offset by pressure from LATAM and lower set sales. General international replenishment demand across the entire T&D and scoliosis portfolio was strong, especially in our agency markets where during the quarter we saw strong procedure growth. In fact, T&D replenishment growth was nearly 20%, and Scoli grew greater than 20%, highlighting extremely strong underlying demand. We are also seeing very strong adoption trends in Canada and Australia. Higher international growth was impacted by Brazil and our conscious decision to limit new set sales to South America in an effort to focus on improved cash metrics. We will continue to focus on profitable growth, improved profitability, and improving free cash flow coming out of our international business as we deliver our overall performance. Within our international business, EU MDR approval remains a large catalyst for our future growth, and we are well positioned for approval. Once our EU MDR status is finalized, we plan to launch several waves of products into the EU. As a reminder, EU MDR approval for implants is an expensive process. We believe it is the right thing to do for kids who need these devices outside of the U.S., and it strengthens our strategic position. Apart from the EU MDR, we have additional international opportunities ahead. Again, we are exploring expansion opportunities for OPSB outside the U.S. in 2025, where we view the regulatory and administrative processes to be very straightforward. In tandem, we are looking to further expand DF2 and expect surgeries for Vertiglide to occur outside of the U.S. in 2025. That brings us to surgeon training and education. In the first quarter, we hosted 172 unique training experiences for over 2,245 healthcare professionals. Recently, we attended the annual meeting for EPOS, the European Pediatric Orthopedic Society, held in France. OrthoPediatrics was well represented, and we were excited that through our significant presence, we were able to highlight our products and interact with many surgeons and customers. Looking forward, we are excited for the upcoming Pediatric Orthopedic Society of North America, or POSNA, meeting on May 13th through 17th in Las Vegas. This is a key industry event for OP, and we will again have a huge presence with multiple sessions, events, and new products on display. In mid-March, we announced our partnership with the Crossroads Pediatric Device Consortium, a multi-institutional initiative focused on accelerating the development, approval, and availability of medical devices designed specifically for pediatric patients. By collaborating with the consortium's network of experts, we aim to drive innovation in pediatric medical device technology and ensure children have access to the specialized treatments they need. Lastly, we are happy to announce that once again, OrthoPediatrics was named as one of the best places to work in Indiana for 2025, marking the ninth time we have been included on this list. We have been able to help as many children as we have as a direct result of the hard work and dedication of our employees, and we are incredibly proud of their work and how they continue to support our mission. With that, I would like to turn the call over to Fred to provide more detail on our financial results. Fred?

Thanks, Dave. Taking a closer look at the P&L, our first quarter of 2025 worldwide revenue of $52.4 million increased 17% compared to the first quarter of 2024. Growth in the quarter was driven primarily by strong performance across trauma and deformity, scoliosis, and OPSB, slightly offset by lower growth in the international business. U.S. revenue was $40.9 million, a 19% increase from the first quarter of 2024, representing 78% of our total revenue. Growth in the quarter was primarily driven by our organic growth in trauma and deformity, scoliosis, and OPSB. We generated total international revenue of $11.5 million, representing growth of 11% compared to the first quarter of 2024, and 22% of total revenue. Growth in the quarter was primarily led by increased procedure volumes, strong scoliosis growth, and reduced trauma and deformity set sales. In the first quarter of 2025, trauma and deformity global revenue of $37.9 million increased 14% compared to the prior year period. Growth was primarily driven by trauma, Pega products, ex-fix, and OPSB, partially offset by lower OUS set sales. In the first quarter of 2025, scoliosis global revenue of $13.7 million increased 34% compared to the prior period. Growth was primarily driven by increased sales of Response, Apifix non-fusion system, revenue generated from 7D technology, as well as increased 3D patient-specific scoliosis braces. Finally, SportsMed's other revenue in the first quarter of 2025 was $0.9 million compared to $1.2 million in the prior year period. Turning to set deployment, $3.6 million of sets were consigned in the first quarter of 2025 compared to $4.3 million in the first quarter of 2024. Touching briefly on a few key metrics, for the first quarter of 2025, gross profit margin was 73% compared to 72% for the first quarter of 2024. The increase in gross profit margin was primarily driven by higher domestic growth, which generates higher gross margin, as well as lower international set sales. Total operating expenses increased $7.3 million or 18% compared to the prior year period to $49.2 million in the first quarter of 2025. The increase was primarily driven by incremental personnel required to support the ongoing growth of the company, including increased non-cash stock compensation, as well as the addition of OPSB clinics. Sales and marketing expenses increased $2.4 million or 17% compared to the prior year period to $16.6 million in the first quarter of 2025. The increase was mainly driven by increased sales commission expense and an overall increase in volume of units sold. General and administrative expenses increased $5.5 million or 22% year-over-year to $30.3 million in the first quarter of 2025. The first quarter increase was driven primarily by the addition of personnel and resources to support the continued expansion of the business, increased non-cash stock compensation, as well as the addition of OPSB clinics. Research and development expenses decreased $0.6 million in the first quarter of 2025 due to the timing of product development third-party invoice during the first quarter of 2025. Total other income was $0.5 million for the first quarter of 2025 compared to $0.6 million of other expense for the same period prior year. Adjusted EBITDA was a loss of $0.4 million in the first quarter of 2025, over 50% improvement when compared to a loss of $1.1 million for the first quarter of 2024. In the first quarter of 2025, free cash flow usage was $8.4 million, representing a significant reduction of 36% when compared to the same period in the prior year. We expect additional cash usage in the second quarter as we continue to deploy sets to support the overall growth of the business, followed by reduced cash usage in the second half of 2025, and we expect positive free cash flow in the fourth quarter of 2025. We ended the first quarter with $60.8 million in cash, short-term investments, and restricted cash, and we still have $25 million available to us on our new term loan. Turning to guidance, we are increasing our expectation for the full year of 2025 revenue to $236 million to $242 million, representing year-over-year growth of 15% to 18%. We are reiterating the guidance that our full year gross margin will be within the range of 72% to 73%. We also continue to expect to generate between $15 to $17 million of adjusted EBITDA in 2025. Additionally, we continue to expect approximately $15 million of new sets deployed in 2025. This represents our continued focus on driving the business to free cash flow breakeven by 2026, and we anticipate delivering our first quarter of free cash flow positivity in the fourth quarter of 2025. Notably, our current guidance absorbs the impact of tariffs and other government changes as they stand today. We will continue to monitor the dynamics, but at this point, we expect potential impacts to be minimal. I'll now turn the call over to Dave for closing remarks.

Thanks, Fred. We are encouraged by how we've carried our business momentum into 2025. Our success this year will be driven by our execution and scaling of OPSB, taking share by leveraging prior set deployments, and the ongoing success of our innovative product launches. We are completely committed to helping more children than ever, aggressively growing our top line, making step function improvements to our adjusted EBITDA, and materially improving our cash usage in 2025 and beyond. I hope you can tell from my tone how encouraged we are by our improving profitability in cash flow. We are on a mission to help one million kids every year, and we believe that building a very profitable and cash-generative business is vital to getting us there. It is well documented that pediatric healthcare is underserved, largely due to underfunding from industry, which has resulted in a requirement for government support. It has been our long-held belief that creating a successful, profitable business that self-funds the future of pediatric technology development is the answer. OP is clearly on that track. In closing, I'd like to thank my associates, our partners in pediatric healthcare, and you as investors for standing with us in this important cause. Operator, let's open the call for Q&A.

Thank you. At this time, we'll conduct a question-and-answer session. [Operator Instructions]. Our first question comes from the line of Matthew O'Brien from Piper Sandler. Your line is now open.

Good afternoon. Thanks for taking the questions. Maybe just starting off on the spine business here, I mean, they're a phenomenally good quarter. And what's typically a seasonally softer quarter for that business. So, Dave or Fred, can you just talk a little bit about what's going on there? How does Verteglide really contribute going forward, plus all the other EOS products you have coming? And then, just maybe the OPSB business and how that's contributing to that franchise. Because as I think about things, I think you're probably, I don't know, like, a couple percent market share, maybe 3%, 4% market share. I guess kind of where can that go, just given all the momentum there?

Yes, thanks, Matt. Yes, really, really strong quarter on the scoliosis side of our business, both implants as well as the specialty bracing side. Really pleased to see that. I guess I would point you back to commentary we made really throughout the second half of last year, where we had very substantial adoption rates, I think a higher adoption rate than we've ever had in terms of scoliosis fusion surgeons coming on board. We opened up some pretty substantial new accounts. And some of that was driven by Apifix. Some of that was driven by just the notion that we are moving forward down this EOS path that I think is really important to our customers. And then a lot of it was 7D placements that really opened up some new big accounts for us that were using our trauma and deformity products but hadn't converted yet to scoliosis. And I think what you're seeing here in the first quarter on all of that is really just the continuation of the momentum that we had in the back half of the year. And you can imagine, we haven't seen the summer schedules yet, but you can imagine that having those surgeons and those accounts on board even before we get to our seasonally high months of June, July, and August feels really good as we move into the summer. And I think with the question related to OPSB, certainly more people using our specialty bracing products is contributing there. I think the synergies that we are seeing very early on, as you point out, but the synergies we're seeing between our customers who have, again, an aspiration to avoid surgery kind of at all costs if they can for these kids, the synergies we're seeing with our commitment to helping them do that as well as having products in EOS as well as fusion products, I think that's leading to surgeon adoption. I mean, we're putting our money where our mouth is in terms of treating the entire continuum of care of scoliosis, and I think we're the only company in the world that's doing that.

Got it. Makes total sense. And then, I don't want to make a mountain out of a molehill here, but, you know, the low end of the range on the top line came up by about a million bucks. By my model, you beat by about a million six. So I guess the midpoint wouldn't quite go up by that million six, obviously, given the range. So anything to call out there that you're a little bit more cautious about, I guess through the first four months of the year versus just traditional conservativism that you guys typically start the year with? Thank you.

No, I don't think so. I think, we haven't got into the summer. We're always nervous. Those are big months in June, July, and August, and until we start seeing that we tend not to be too aggressive there. And so, I would say that's kind of generally we hew to that principle. I do think, you obviously saw us once again managing the international business a little differently. We're not going to continue to get out over our skis there. I think we have an opportunity for better collect cash collection, particularly in Latin America. And so we continue to be judicious, I think, about how aggressive we are in some of those markets where we could have orders, but we may push those orders to help improve cash flow. And so I guess those are two areas, but nothing I think that we would have we'd call out any different than in prior years.

Got it. Thanks so much.

You bet.

Thank you. One moment for our next question. And our next question comes from the line of Ryan

Hi, Dave, Fred. Thanks for taking our questions. And definitely heard your tone there. Appreciate that. I want to ask about 7D actually, because its going pretty well for you guys. I'm curious, Dave, you can talk about the interplay between where accounts that have 7D and kind of the impact that has on adoption of your scoliosis products. If you're seeing, you know, greater uptake, specifically within the scoliosis business in those accounts, and can we kind of look at those as leading indicators, I guess, of kind of greater scoliosis growth, because they have that 7D or enabling technology in the account?

Yes. I mean, certainly in places, Ryan, where we didn't have any business, obviously, we're seeing a lot of uptick. And I think what we saw, particularly in late Q3 and throughout Q4, was some of those placements were in locations where we had nearly zero pedicle screw sales. And we had a lot of trauma and limb deformity sales. And so the 7D units, essentially everything that we're getting in terms of response fusion sales there is all growth to the top line. There are other locations where we have pretty substantial share. And we may not be getting as much uplift in those accounts. But you can imagine the Salesforce is pretty aggressively targeting locations where we need a breakthrough in terms of getting some movement on response fusion. And I think that's what you're seeing in the growth numbers is that largely adoption by surgeons who have been exposed to our response system through the 7D deployments. I guess one thing I would point out is, we are in development of obviously new products on the EOS side. You see, you know, Verteglide approval, LE coming down the pipe here. Those are also technologies that will benefit from navigation and as we've called out on the Analyst Day, we're working on an entirely new fusion system. And so I think the future is pretty bright when you see that the growth of our fusion business with a system that's been out there for a while is as robust as it is. And then the technology that we have coming behind that here over the next, let's say, six quarters, pretty substantial. So I think we like the tailwinds that we have within that business.

And Dave, to follow up on scoli for a minute, I mean, your portfolio is now very wide. You have this breadth between response and Apifix and Verteglide. I'm curious, where you see, how you think about any gaps that maybe you had before? How we as investors should think about the scoliosis, breadth and also like the interplay between devices. I mean, if you didn't have Verteglide, I don't think someone's using response. But is there any kind of swapping out or things that we need to think about as you broaden that breadth of the portfolio? I guess I'm just trying to understand kind of the totality of the scoliosis portfolio.

Yes, great question. I think that what investors really need to understand about our scoliosis business is that it's very different than an adult spine business and that we essentially treat one indication, right? It's purely scoli. We're not doing a lot. We don't do a lot of interbody work. We're not we're not treating a number of the indications that are seen in adults. And why that benefits us, obviously, it's a smaller tan, but why that benefits us is that is we have this intense focus on all of these solutions that accommodate the complexity associated with scoliosis. And so I think that Verteglide, Ribbon Pelvic, obviously, we haven't done a case yet with Verteglide, but we're just getting started. And eLLi, those products are designed to treat, I would say, far and away the most complex early onset scoliosis or syndromic patients that are treated at the major children's hospitals by some of the top pediatric orthopedic surgeons in the world. And historically, those were the places where we have had more difficulty getting our scoliosis products on contract. They're historically dominated by some of the larger adult spine companies that have just had a head start on us. And so as we make investments where other people are unwilling to make investments in these maybe slightly smaller markets, it really shines a positive light on what we're doing as a company to meet the unmet needs of those very specific patients and by default, those surgeons. And then I think it gives us a lot of ammunition, a lot of credibility to talk to those surgeons about the rest of our product portfolio and pull through our fusion devices, get Apifix on board, get 7D there. And we're already seeing that simply by doing the work in that area of early onset scoliosis. I really believe that when you see the combination of rib pelvic, eLLi and Verteglide, there's nobody else who will have anything close to what we have on the EOS side. And I think that will be very well recognized by customers at the largest institutions.

Very helpful, Dave. Thank you.

Thank you. One moment for our next question. And our next question comes from Rick Wise of Stifel. Your line is now open.

Good afternoon to you both. Nice to see the solid quarter here. I wanted to tackle a couple of things. One, the gross margin guide, Fred, you said 72, 73, but just help us think through it from two vantage points. One, why wouldn't it be 73 plus just thinking about it? You keep adding all these new attractive, compelling products. You just outperformed strong U.S. sales. I don't know that the U.S. dynamic is going to change radically. Just help us think through both the cadence for the quarters and maybe how we should think about the outlook as well?

Yes, absolutely, obviously very pleased with strong first quarter here, great start to the year, only 11% growth and very limited set sales on the international side, two biggest contributors there. Assuming international, we do sell sets internationally in the future that will pull it down a little bit. And then you may recall typically the fourth quarter is often a softer gross margin number for us as well. So as Dave said, we're still anticipating a strong summer. We haven't seen it yet. Be great when it gets here, but we obviously don't want to get ahead of ourselves. And so we'll stick with what we have for right now and kind of let the performance speak for itself going forward.

Okay. Maybe turning to the especially bracing clinic expansion part of the story, Dave, obviously you sounded particularly excited there and all the progress and opening North Carolina, et cetera. And I just wanted to -- I thought it might be instructive for us all to hear about your clinic expansion efforts in Florida and Colorado. It's been like something like six months, if I recall, since they happened. Any incremental details you can recall or you can share about the ongoing ramp to being fully productive. Where are we there? How does that how might that suggest we should think about future clinic expansion efforts? How are you thinking? And can you talk a little bit more about your plans over the next, not just the next quarter, but over the next six, 12 months even for further expansion in the U.S. and internationally?

Sure. Well, you could assume, Rick that we have no plans to slow down the clinic expansion strategy here. We're not going to call out specifically how many more we think we can get done, but it's reasonably likely that in the second half we could expand. I think what we're also seeing is in places like Colorado or Florida, really seeing this in Ohio, where we have new clinics starting to see more throughput from those clinics. So I think Fred and I are both really pleased with the increases in volume we've seen. We're seeing the usage of our sales force, both the surgical sales force, as well as the addition of OPSB members that are helping make surgeons aware of how they can have a clinician that is 100% focused on pediatrics and so see nice uptick generally in those clinics. So I'm really pleased with the not only the territory expansion, but what we're seeing from the territories that we've expanded into. Obviously, a place like Florida is very early. We have a number of other clinics within the territory that we're working on. And I think when those clinics are set and we're moving forward, we're going to continue to see growth from the locations we've already set up. And then that becomes a bit compounding when you start adding new clinic opportunities in new jurisdictions or new territories. I think now a year into it and we've done several expansions so far, the pipeline is very full. And as we kind of knock out one, three more continue to add. And so I think we have several years of expansion and growth ahead of us for this section of our business. And we're 34, 35 clinics at this stage. I mean, I'm not going to call out what you're going to see in the next six to twelve months, but I think, over the course of our time here, three to five years, our intent would be to dominate this the market share in this space. And there's 300 children's hospitals. So we have a lot of work to do to continue to scale. I think on that side, pretty interesting because we are having some success with what is still a fairly limited scoliosis portfolio due to lack of approval on our small stature system. But we're having success already with our implants in certain pretty key markets in Europe and seeing growth still small, but the growth is large. And that is also then leading to conversations that we maybe didn't expect to have a year ago. And that's leading to these conversations with pediatric spine surgeons who are now using our fusion devices about how we could serve them on the scoliosis bracing side. And so there's a few opportunities for us there that are good ones and don't require MDR approval. And so, I think it would be fair to say that if we got good opportunities for expansion in certain particularly markets in Western Europe, that that we're going to take those opportunities. And I think it's going to be good business for us.

Appreciate the color. Thank you.

You bet.

Thank you. One moment for our next question. And our next question comes from a line of Ben Haynor of Lake Street Capital Markets. Your line is not open.

Good afternoon, gentlemen. Thanks for taking the questions. First off for me, it's great to hear the productive conversations that you've had with the FDA on eLLi. I was just wondering if there's any more color you can share there on maybe what your understanding is presently on what a submission could look like there or really anything you can share on that part?

Yes, I guess without getting too detailed, I think that our concerns early on would be that we would have to do some a big PMA, some type of multi-year study. I think at this stage, we think that is a, well, we think that is a very, very small likelihood that that would occur. And so I would say the FDA recognizes the need for this device in the marketplace and that the patients that need that and are working with us the way they should be, particularly with a device that has breakthrough device designation, to make the pathway for that approval rational and cost effective. But also one in which we do need to collect data on some levels to make sure that the device is safe and effective. And I'm just really, really pleased with the way the FDA has operated here in the last five months, four months. And we've seen maybe a change of tone on Vertiglide because I think we told you all that we were a little concerned that Vertiglide could drag on and then through productive conversations, it didn't. And I would just say that the tone of the conversations we're having around eLLi is very similar to the tone of conversations we had around Vertiglide, which is why we're quite optimistic.

Excellent. They're very encouraging, obviously, there. And then secondly for me on the EU and the MDR, what is kind of that first bolus of products that you're taking through there and what sort of, I don't know, case mix is the right word, but what sort of market share of procedure volume do those sorts of products hit in these European markets, if that makes sense?

Yes, so I would say the first few approvals will be on the trauma limb deformity side. So we have a number of products there, we just don't have available. And what's also interesting, Ben, is that we have a number of products that are within a number of individual SKUs or instrumentation or sizes that are included in U.S. sets that make those sets more competitive and far more useful to a surgeon that are available to U.S. customers, but not available to OUS customers or customers in Europe. And so it's not only just a bolus of literally new systems, it's a bolus of different products that could modernize some of the other systems that we already have in market and could take additional share as a result of having some of the more modern instrumentation and implants. Some of the systems that we've been selling in Europe have been unchanged really for 15 years, and that wouldn't be the case or the experience that you would see if you were in Indiana or Ohio utilizing our products. There's kind of been a constant upgrade. And so the European surgeons haven't seen some of those upgrades. So I think the first things you're going to see are that, those types of devices that will help drive share through kind of our legacy products and some of the products we already have onshore in Europe. And then I think the bigger ones are -- we have half of our portfolio scoliosis products available in Europe. We've launched the business there. It's still small. But if you can't launch your small stature system and you're a pediatric orthopedic implant company, that's a tough go, right, in terms of trying to capture market share there. We're doing that with the 5560 response right now, but having the 4550 fusion system, as well as some of the other devices that make their response system very unique, I think are going to be a bigger catalyst maybe than anything.

Excellent, that makes a lot of sense. Thank you, gentlemen, for taking the questions.

Okay. Thank you, Ben.

Thank you. One moment for our next question. And our next question comes from the line of Mike Madsen of Needham & Company. Your line is now open.

Hey, Fred, hey, Dave, this is Joseph on for Mike today, but maybe just to start off with DF2, the expanded indication there and post-operative management, I don't think you guys would maybe size the market with that. I was wondering if you could maybe tease that out a little bit and just maybe talk about if you've had any traction there with that indication, I guess maybe watch your expectation for post-operative use in 2025. And then just on OPSB, I think you guys called out two launches on this call so far in the year. And I believe your slide deck says the goals for this year. So I was just wondering if you could maybe talk about those other two launches coming, if that information is correct?

Yes, good question. So I guess let's just start with the bracing launches. I think, the likelihood that we would get to four launches, if not more, is very high. I mean, the unfo [ph] product as well as Thrive are both products that we have experience with our clinics and now are able to sell through those two companies and expand them to all of our clinics as well as clinics that we don't own. And so we have pretty constantly seen pretty unique technologies that can't get scale because they're just so small that we have access to. And so it's really the timing of that for the sales force to determine how fast we want to do that. We are working on a couple interesting new products as well. We did the first bracing sensor for scoliosis. I don't think we called that out, but we have launched that product, just done a few cases here, I guess in April with our bracing sensor. So that is moving forward and has been well received. And then a lot of what we're working on right now on the OPSB side is around the pediatric hip, children with developmental hip dysplasia, a big market opportunity there for us. And so we're working on a couple of different products there. And then we are working on a product that is connected to one of our Orthx devices as well. And we're starting to see the potential for interplay between some of the implant systems that we have and how those implant systems could potentially be married with post-operative bracing. And in the ExFix case, it actually could be interdigitated into the device itself. And so that's the primary things that we're working on. And I think we'll likely cruise to at least four products on the OPSB side for sure.

Just regarding the DF2 market size, there's no data for that, but it's actually converting. We’re converting what today is basically a spica cast, typically, which is just below the nipples all the way down to just above the knee. And that spica cast, which, as you can imagine, is difficult to put on. They have to put the patient under. And for a parent to deal with that is very, very difficult. We're replacing that spica cast with a hip brace. And so there's really no market data that tells us the size of that. But what I can tell you is that this brace is quickly becoming the new standard of care and is absolutely winning over surgeons left and right. It's just so much better than what they had to deal with before. Not only the surgeons, but the parents as well. So we're very excited about that. Unfortunately, we don't have any data that we can point to tell you the size, but we're creating a market with this brace, which is absolutely what we want to do in many of our situations here with this bracing opportunity.

Okay, great. Yes, fair enough. That makes sense. Definitely understand that can be a transformational product given what's being used now. But I guess just to layer on, you have all of these launches that you're expecting here in 2025 in the second half, potentially in Europe, OPSB ramping. I'm just curious how you guys are thinking about manufacturing capacity and potential expansion there. Whether this year, next year, I know you guys have product launches for the next three years. So just kind of wondering how you're thinking about all that?

Yes, it's a good problem to have, which is increasing capacity. Right now, we're only working two shifts, so we have another shift that's available to us, but we starting really when we first acquired this business back in January of 2024. It's fully expected to have increased demand and have been working on increasing capacity both in the short term, but also in the longer term as well. So good problem to have. We're working on it and don't see that as the limiting factor for us right now.

Okay, perfect. Congrats on the strong order you guys. Thank you.

Thank you much.

Thank you. I'm showing no further questions at this time. I'll now turn it back to David Bailey for closing remarks.

Great, thanks, operator, and thank you all for joining us on the Q1 call. I look forward to talking to you all over the course of the next several months. Have a great evening and we'll talk to you soon.