OrthoPediatrics Corp (KIDS) 2025 Q4 法說會逐字稿

Good afternoon and welcome to Ortho.

Welcome to Ortho Pediatrics Corporation's fourth quarter 2025 conference call.

(Operator Instructions)

After, as a reminder, this call is being recorded for replay purposes. I would now like to turn the call over to Philip Taylor, Investor relations, for a few introductory comments.

Thank you for joining today's call. With me from the company are David Bailey, President and Chief Executive Officer, and Fred Hite, Chief Operating and Financial Officer. Before we begin today, let me remind you that the company's remarks include forward-looking statements within the meaning of federal securities laws, including the safe harbor provisions of the Private Securities Litigation and Reform Act of 1995.

These forward-looking statements are subject to numerous risks and uncertainties, and the company's actual results may differ materially. For a discussion of risk factors, I encourage you to review the company's most recent annual report on Form 10-k, which was filed with the SEC on March 5, 2025, to be updated next week. Its subsequent quarterly reports on Form 10Q.

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 fourth quarter 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 Ortho pediatrics 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, February 26, 2026, 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, Philip. Good afternoon, everyone and thank you for joining us today. We're proud to start this call with our typical and most meaningful performance metric. In the fourth quarter, we supported the treatment of more than 37,500 children, increasing our total impact to approximately 1.3 million kids helped.

Historically, the medical industry has overlooked the importance of offering custom tailored solutions to the unique needs of pediatric patients.

At orthopediatrics, we are changing the status quo by bringing an unparalleled level of attention and innovation to the pediatric market, and we will continue to advance this goal.

We closed out 2025 strong with 17% 4th quarter revenue growth, representing growth across the entire business, improved, adjusted EBITDA over the prior period, and generated $10 million of fourth quarter free cash flow, which is our first quarter of positive free cash flow in the company's history.

Full year performance for 2025 was highlighted by 15% revenue growth, nearly 75% increase in adjusted EBITDA, and a drastic improvement in cash usage down to $15 million from $41 million in the previous year.

Our track record of execution is a strong indication that we can sustain meaningful top-line revenue growth while generating increasing profitability and delivering cash flow breakeven in 2026.

We are uniquely positioned among peers of our scale with the ability to drive both top and bottom line growth. To that end, we are the clear market leader in pediatric orthopedics, and we have now demonstrated that our self-sustaining business model can grow the topline. Generate positive adjusted EBITDA and deliver a positive FCF.

We feel that the investment community is underappreciating the strength of our position, and we intend to keep exploring all options at our disposal to improve shareholder value while advancing our mission to help 1 million kids every year.

I also want to emphasize today that in 2025 we commenced what we believe is the most substantial and technologically advanced series of product launches in OP history.

This kicks off a multi-year super cycle of product innovation and launches that will serve as the foundation of our growth for years to come.

Notable products include 3P hip, Verteglide , new OPSB products, halo gravity traction, Playbook on the enabling technology side, as well as the LE electromechanical growing spine system with first in human yet this year.

As this expansion of our portfolio strengthens our foundation in orthopedics over the medium term, we are looking to broaden our footprint into other pediatric subspecialties while expanding our canon and further leveraging our powerful global commercial channel.

Considering all these factors, we are approaching 2026 on track to make excellent progress towards our goals with a few primary goals in mind.

Continued sharetaking across the business.

Further OPSB expansion.

Execution of our multi-year new product super cycle, leading to stronger EBITDA margin as well as dramatically improved free cash flow performance. We are reiterating our 2026 revenue guidance of $262 million to $266 million representing annual growth of 1%1 to 13%.

And we expect to generate approximately $25 million of adjusted EBITDA while achieving free cash flow break even for the full year.

Turning to our TND business, in the fourth quarter of 2025, the TND business grew by 17%, driven by increased sales of our flagship trauma and deformity systems and continued deployment of new product sets.

Highlights of the quarter included our continued full commercial launch of the first ever pediatric tibial nail, PMP tibia, and the beta launch of 3P pediatric plating platform hip system.

Our 3P hit system has exceeded expectations in its early stages, and this system is expected to contribute materially to revenue growth with a full commercial launch expected in the first half of 2026.

We were also thrilled to receive FDA approval for the 3P Small Mini, the second system in our 3P plating family.

We'll be conducting the beta launch of 3P small minii in 2026 and expect to continue advancing development on several new 3-P systems that will be launched over the next 3 years.

With our 3 piece system continuing to build momentum, we believe that it will prove to be the most advanced and comprehensive pediatric plating system in the history of our specialty.

To wrap up on our TMD business, we're following the extremely successful launches of PMP femur and PMP tibia with PMP Retro, the first and only pediatric retrograde I am nail system, while also expanding our leadership in telescopic nailing for rare bone diseases with the next generation FD rod. Overall, TND continues to be the pacesetter for our business, and our development pipeline has never been more clinically relevant and full of promise.

Looking at our specialty bracing business.

OPSB continues to be a strategic growth catalyst supporting both our revenue growth and profitability in a meaningful way while further strengthening our customer relationships.

As such, the business continues to see success, and our clinic expansion strategy is ahead of schedule. In Q4, we expanded our footprint in Connecticut, and we expect to continue executing our successful strategy for both Greenfield and Aquahier expansion.

Same store sales growth remains strong, and new product launches and salesforce expansion are going very well. We also continue to remain open to opportunistic acquisitions that fit our strategic focus.

On the product side, OPSB saw a flurry of new launches in 2025, including expanding indications for the DF-2 braces that has exploded in popularity and is changing the gold standard for treatment in pediatric femur fractures in young children.

Additionally, we beta launched a trio of bracing products for the treatment of hip deformities that are in the process of moving to full commercial release in 2026.

Within OPSB, we are now fully on track to meet or exceed our annual goal of 4 to 5 new product launches every year for the foreseeable future.

In addition to the full commercial launch of the 3 solutions that make up the PD hip brace portfolio, we will launch two products aimed to be used in synergy with OP implant systems to treat the entire continuum of care for kids. These are the Traxio Halo Gravity traction System in partnership with the Sinetech Group and the OPSV knee and ankle tractor fix braces meant for treating contractures following exfix surgery.

It is evident that we are continuing to execute against our three-pronged plan for OPSD salesforce expansion, focused new product development, and measured clinic expansion. Ultimately, we could not be more pleased with the OPSB performance and its strategic impact.

In scoliosis, we experienced 13% growth in the fourth quarter of 2025, and we were particularly pleased with our EOS product launches. Throughout 2025, we continued our push into the EOS space with the full launch of Response riven Pelvic and the beta launch of the much awaited Verteglide system, providing a promising new growth friendly treatment option for young scoliosis patients.

Notably, in the second half of 2025, we completed the first surgical cases with the Verteglide system, making an introduction of this technology into clinical use.

I think it's important to stop and recognize the impact technology like Vertiglide can have on a young person's life.

We recently received feedback from a surgeon on his first Verteglide postoperative visit with a patient. The smiles on the patients and their families' faces told him everything he needed to know without saying a word, and they shared a deeply moving moment. The patient's motor functions were improved, and that level of neurologic improvement is highly uncommon in this respect of patient population.

This technology is literally transforming patients' lives. We're seeing solid early usage of the Verteglide system in its limited release and plan to move to full market release in the coming months.

We are proud of our successful launches in 2025, and they further bolster our belief that our EOS strategy is working.

In addition to the full launch of Verteglide , we're nearing completion of our 3rd and most complex EOS product, eLLi.

As a reminder, eLLi is a next generation smart electromechanical lengthening spine implant designed to deliver consistent and reliable power through RF power transmission.

We expect the first implantations of the eLLi device in late 2026.

Beyond declaring victory on the most technologically advanced and comprehensive EOS portfolio in pediatric spine surgery, we also expect to complete development and beta launch our next generation scoliosis fusion system in the second half of 2026 in conjunction with a suite of unique predictive preoperative planning software. Once complete, we believe OP will offer an unrivaled portfolio of pediatric scoliosis technology that will allow our customers to treat children with the most severe and complicated pathologies.

Moving to our international business.

US growth rebounded with a strong fourth quarter highlighted by solid demand in our direct markets in the EU and Australia.

Surge in usage was high across the portfolio, and we saw a strong rebound in Latam from replenishment orders. EMEA and APAC revenue was very solid, which largely comes through our sales agencies and is a good reflection of high surge in usage and higher margin replenishment revenue.

From a strategic standpoint, we made structural improvements in Brazil through the purchase of one of our Brazilian distributors, Flomed, in late November.

We believe over the next several quarters this acquisition will enable us to improve our cash collection and over time normalize ordering patterns to drive additional growth and market penetration in the region.

We are also very excited about the EUMDR approvals for several TND and scoliosis products, as well as on a recent approval for our X6 devices. Efforts are now underway to provide our EU markets with products they have long been waiting for, and we expect this to have a positive impact on EU growth in 2026.

Lastly, We'd like to underscore two developments outside of our traditional segments. It's very early and revenue is small, but we are building on the success of our 7D experience and are kicking off the launch of our comprehensive digital surgical platform playbook.

It is designed to support teams across the full continuum of care from preoperative planning through intraoperative execution and post-procedural performance analysis, and we expect deployment to beta launch sites in 2026.

Additionally, as announced following the FDA approval of key pediatric indications during the fourth quarter of 2025, we have placed our first iota motion unit at Cincinnati Children's Hospitals. Under our exclusive partnership with Iota Motion, we are moving towards the full commercial launch of OP's first non-orthopedic technology. This milestone allows us to leverage our existing capabilities and to bring the same discipline, focus, and pediatric-first expertise beyond orthopedics. And we are excited to advance this innovative technology.

With that, I'd 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 fourth quarter of 2025 worldwide revenue of $61.6 million increased 17% compared to the fourth quarter of 2024. The increase in revenue in the quarter was primarily driven by strong performance across trauma and deformity, scoliosis, and OPSD.

US revenue was $48.6 million a 13% increase from the fourth quarter of 2024, representing 79% of total revenue.

Growth in the quarter was primarily driven by trauma and deformity, scoliosis, and OPSB.

We generated total international revenue of $13.0 million representing growth of 33% compared to the fourth quarter of 2024, representing 21% of our total revenue.

In the fourth quarter of 2025, trauma informed the global revenue of $42.6 million increased 17% compared to the prior year period. Growth was primarily driven by strong growth across numerous product lines, specifically our pega products, Xfix, PMP Tibia, and OPSB.

In the fourth quarter of 2025, scoliosis global revenue of $17.6 million increased 13% compared to our prior year period. Growth was primarily driven by increased international implant growth as well as OPSB.

Finally, sports medicine other revenue in the fourth quarter of 2025 was $1.4 million including Iota motion robotics sales, as compared to $0.6 million in the prior year period.

Touching briefly on a few key metrics for the fourth quarter of 2025, gross profit margin was 73% compared to 68% for the fourth quarter of 2024.

Total operating expenses increased $3.7 million or 7%, compared to the prior year period to $53.3 million in the fourth quarter of 2025.

Sales and marketing expenses increased $1.6 million or 10% compared to the prior year period to $18.4 million in the fourth quarter of 2025.

General and administrative expenses increased $5.5 million or 23% year over year, to $30 million in the fourth quarter of 2025.

The increase was primarily driven by the addition of personnel and resources to support the continued expansion of the OPSB business and increases in non-cash item such as stock compensation, depreciation, and amortization.

Trademark impairment increased $0.6 million for the prior year period to $2.4 million and we recorded a restructuring charge of $0.3 million as a result of our prior cost rationalization efforts as compared to $3.7 million in the fourth quarter of 2024.

Research and development expenses decreased $0.7 million in the fourth quarter of 2025 due to timing of third-party related services to product development.

GAAP net loss per share for the period was $0.43 per basic and diluted share, compared to $0.69 per basic and diluted share for the same period last year.

Non-GAAP net loss per share for the period was $0.30 per basic and diluted share compared to $0.29 per basic and diluted share for the same period last year.

Adjusted EBITDA was $4.8 million for the fourth quarter of 2025, a 59% improvement when compared to $3.0 million for the fourth quarter of 2024.

We ended the fourth quarter with $62.9 million in cash, short-term investments, and restricted cash.

Set deployment was $4.5 million in the fourth quarter of 2025 compared to $3.7 million in the fourth quarter of 2024.

As Dave mentioned, we are very excited to have generated $10 million of free cash flow in the fourth quarter of 2025, contributing to a dramatic improvement in our total year free cash usage of $15 million for 2025 as compared to $41 million in 2024, a $26 million improvement, or 63%.

Turning to guidance, as Dave mentioned, we reiterated our expectation for full year 2026 revenue to be in the range of $262 million to $266 million representing year over year growth of 11% to 13%. We also continue to expect to generate approximately $25 million of adjusted EBITDA, deploy approximately $10 million in sets.

And to achieve free cash flow breakeven in 2026.

We would expect the EBITDA and free cash flow to exhibit similar quarterly seasonality patterns as to 2025.

It is important to note some periods will be negative and others positive, but still cumulatively tracking to an annual guidance metrics.

Operator, let's open the call for Q&A.

Thank you. (Operator Instructions)

Matthew O'Brien, Piper Sandler.

Oh, afternoon, thanks for taking the question. Maybe just for starters, the scoring number in the quarter was quite strong. Can you just maybe talk a little bit about what you're seeing there? I know it's a category that, it's like it's significant, but, there's, I think a little bit more competitive pressure coming from at least one fine company. So just maybe talk about what you're seeing there, and then, the outlook for that franchise going forward, and then I do have a follow-up.

Mac continues to take share and then, just early returns as we indicated with the Verteglide system, and, now that we've got the rib and pelvic, Verteglide out and working on Elli, I think the EOS portfolio is, really driving, surgeons who may have not used our product in the past, at least on the scoliosis side to take us quite seriously.

A lot of our first procedures with Verteglide are in, accounts where we didn't have. We didn't have cases or we didn't have, a fusion business, otherwise. So that's very encouraging as we look at 2026 and beyond. Last thing I would say is, due to the EUMDR approval we now will have or now do have the full product of portfolio minus Verteglide approved in Europe and we're seeing really strong returns already with just the 5,560-response system. But now when you add the rest of the portfolio of that business is growing really rapidly. Obviously you see that in the international number as well. So very pleased and I think we continue to accept, expect more of the same and we've got a very robust pipeline of very unique products that are kind of unlike anything that exists on the market that's coming out over here the next 18 months, so pretty exciting.

Appreciate that, Dave, and then Fred, just the margin progression in the quarter was really strong gross margin and operating margin. I know you were talking about it recently or just the last few minutes here, but just the outlook for those metrics going forward. I mean, are we in kind of a new era for OP in terms of how we should think about the scaling of the business and the profitability of the business, which is obviously very important right now. Thanks so much.

Yeah, absolutely. So very pleased with the drop through, in the fourth quarter. So, revenue increased nicely but also dropped through nicely to the bottom line of the business, strong gross margin at 73%, as we've talked about in the past, we would expect.

Whole year of 2026 to be a similar 73 range of gross margin and then the adjusted EBITDA going from $15 million in 2025 up to the $25 million in 2026 and that'll come from leverage on the little bit of leverage on the sales and marketing side of the business. Because OPSB is growing faster than the overall business and they have a lower percentage of sales on sales and marketing and then the rest of the leverage will continue to come from the cash portion of G&A, which is where a lot of it came from in 2025.

Thank you.

Thanks man.

(Operator Instruction)

Rick Wise, Stifel.

Rick, your line is open.

One moment for our next question.

Matthew Blackman, TD Cowen.

Good afternoon, everybody. Can you hear me okay?

Just fine, man.

Oh, great, thanks for taking my question, Dave. I can't resist. I'm new to this story, so maybe this is a comment you've made in the past, but I did pick up on you saying, quote, exploring all options to increase shareholder value. Just anything worth expanding on what we should take from that comment, and I've got one follow-up.

Yeah, I think.

We have intimated to the team or to this group for a long time that, we believe that the infrastructure that we have built here at OP, particularly the commercial footprint that we have, is really the most powerful commercial footprint in the children's hospitals will benefit us down the way. And I think, we continue to be interested, in expanding that footprint and leveraging, particularly the commercial channel to get into other pediatric subspecialties. And, many of those subspecialties obviously are less capital intensive than the orthopedic space. And so while I think we have a big several years ahead of us in terms of continuing to share a grow share, particularly with the new products that we have coming down the pipe. I think you could expect us to continue to be quite interested in expanding our CAM through opportunities and other of subspecialties and, continuing to expand, our footprint in the pediatric healthcare market overall. And so I guess that's what I'm pointing to more there.

Okay, I appreciate that. And then Fred, just you gave us some, guidance on EBITDA. Can you help us similarly, on the topline? And is 2025 as well a good proxy for how we should see, the revenue flows this year? Thanks. Appreciate it.

Yeah, it's a great question, and the answer is yes. So, 2025 is a good proxy for both revenue across the quarters as well as EBITDA as well as a free cash flow. So as a reminder, revenue is always softest, smallest in the first quarter. That'll be true again here in 2026. The third quarter is always the strongest as the kids are, many of the kids are out of school, and the revenue then drives the following, obviously adjusted EITA as well as. Cash flow we try to get as much of our set deployment out in the first half of the year, so first and second quarter and first half of the year will be negative free cash flow and then positive second half free cash flow to get the entire year to a break even, which is about a $15 million improvement over 2025.

Got It. Appreciate it.

Thank you.

Thanks Matt.

Thank you. (Operator Instructions)

Caitlin Roberts, Canaccord Genuity.

Hi, thanks so much for taking the questions.

Hi, just starting on 7D, just updates on the placements in the quarter and, any updates to the strategy as well there.

I would say it was a fairly normal quarter, not wild growth. We did get a, we did get some unit placements, so that was good, but, still I think we have at least experienced, continued slow movement in terms of our customers' willingness to certainly everybody's interested in trying and wants to get, units in, but the paperwork processing has been a little slower than we would like. I think the funnel is very large. We've got a lot of demos going on now and, we're optimistic that, 2026 will be good for 7D.

I think we're focused on what we're really excited about is the performance in places where we already have 7D that we placed throughout 2024 and 2025. We see really strong performance, with our implant business. That's what's helping drive the response fusion growth that we're seeing. And again, I think, we've not forecasted in the model or in the guide, a big jump in 7D, but certainly we expect to place numerous 7Ds in 2026.

Understood, and exciting updates with playbook and Iota motion. Just anything built into the guidance in 26 for those launches and then just kind of the cadence of those launches as well.

Yeah, I would say extremely small, at this stage in terms of the guy. We obviously just sold our first unit, within days of the FDA approval here in the fourth quarter to Cincinnati Children's.

That said, there's a lot of interest, a lot of demand in that, and I think this product line is being used on the adult side, fairly frequently. So, we're seeing a lot of inbound interest in that, but we don't have a lot of that, or the playbook technology baked into the guide at this stage.

Understood, thanks so much.

Thank You.

Thank you. (Operator Instructions)

Ben Hayman, Lake Street Capital Market.

Good afternoon gentlemen. Thanks for taking the questions.

First off for me it's been quite a few, months now since the last investor day. Can you maybe talk a little bit more about Playbook, how that fits in, how things are done, in most hospitals today, kind of what holes it fills, just where Playbook fits into the overall, mix.

Yeah, absolutely.

Good question. Again, Playbook Is, I would say the first foray of ours into let's call this the digital health space. It's probably not an enabling technology and then it's not a navigation platform or anything like that, but Playbook ultimately helps, hospitals, with and surgeons through custom workflows, ultimately streamline surgical procedures and then capture data about each one of those steps. And then provide the hospital with metrics about how those steps can be sped up and improved.

So, playbook is a lot about, improving the quality of surgery in pediatric, in the pediatric patient population. Not that dissimilar to what you might see a lot of the bigger adult, hospitals are obviously trying to maximize the efficiency with common procedures like total joint reconstruction and adult spine. And I think there's enough variation in, the techniques. And use cases for a lot of our products that we see a lot of times wild differences between, what one hospital or might take in terms of total time to perform the same procedure than another hospital or another OR and we're trying to drive some gold standard processes and pediatric orthopedics and help our customers ultimately capture best practices. And I think that is pretty valuable for patient care, no question.

We think it's pretty valuable for our hospitals to be able to improve their efficiency, which makes them more profitable. And we ultimately think the data capture here, is going to be very unique for pediatric orthopedics because there's no data. We're generating data and capturing data that's never been captured before. And, our Smaller kind of segment of the orthopedic marketplace, there hasn't been focus there. So we got a lot of interest in the product line already. It's very early days. We hope to have a few of these systems beta launched in a few accounts here fairly shortly. Again, not a lot of revenue baked into this, but, this thing, once we get going, could be, it could be really special for the business and I think, really helpful for our surgeons and the patient population.

So in other words, you, there isn't something that you're necessarily displacing. There isn't some, software that's typical for adults or anything like that some of these folks are using.

This is first of its kind new to the children's hospital for sure.

Okay, got it. And then just on the subspecialties that, you're looking to expand into, are there any notable ones more attractive or less attractive than others?

Yeah, I mean, obviously we've found that, we've been very successful in our expansion from purely implants in the operating room to the kind of near adjacency on the OPSB side. We're going to obviously continue to scale in that space, but I think the Iota motion deal is a good example of how, we are commercially present in these very high-profile children's hospitals. Litals like Cincinnati Children's and we are, being approached by, a number of these companies, oftentimes fairly small with very credible but an interesting technology that struggle to access these hospitals and aren't currently present commercially in these facilities and so partnership without motion I think is a good test for this and that. We're not in the ENT space.

We're not selling cochlear implants at this stage, but we are certainly now toe dipping, so to speak, in the ENT space, and I think that would be a rational opportunity for us in the future. We also really like a lot of technologies on the cardiovascular space, and I think there's an opportunity to ultimately grow a business in the cardiovascular space that could mirror the kind of market dominance that we have in pediatric orthopedics. And those are just two kind of right off the top of my head, but we find that each subspecialty in pediatric healthcare has a very similar volume of unmet needs that we used to see when we started orthopediatrics nearly 20 years ago. And I think what we like about some of those verticals is that, orthopedics is a capital-intensive business. It's taken us a lot of time, energy, and capital to grow to the dominant share position that we have in. Hospitals now I think we need to be able to leverage that commercial position as well as our internal infrastructure to support some of these entrepreneurs with credible technologies and subspecialties that have maybe even slightly more favorable economic dynamics, particularly when it comes to cash flow and cash usage.

Got it. That's very helpful caller. Thanks, gentlemen, for taking the questions.

Thank you.

Thank you. (Operator Instructions)

Mike Matson, Needham and Company.

Yeah, I thinks. So, I want to ask one on, R&D, just looking at our model, it occurred to me that, I know it was down in the fourth quarter percent of sales, and you called out some timing, but you're looking back over the entire year of 2025, it was down a substantial amount, and not just on a percent basis but on an actual dollar basis. So, I guess it's great to see you're getting some leverage, but how do we get. Confident that it's not, compromising the pipeline or something like that. I mean, it seems to be you're launching a lot of products, so it doesn't seem to be the case, I guess, but.

Yeah, I think.

We are, that's a great question, and I think it's a question that Fred and I have challenged the team internally. Our product development is extremely efficient and we're doing a lot of things simultaneously. I think one thing is there is a lot of timing, Mike, associated with. For example, when test parts come in and have to be tested, and those are big swings, right and so there are going to be swings probably in the coming 12 months here, especially in product lines like Elli and our NextGen Spine, some of the three-piece systems where the internal work has been done, we're ready to start manufacturing and doing some more internal testing or testing for FDA that will drive that R&D line up a little bit. But what I would just say is that some of that didn't happen, particularly here in the back part of 2025.

But, again, I've been here nearly 20 years, we have never had a more credible or clinically exciting R&D pipeline than we have now. And I think Verteglide and seeing the early patient and physician feedback associated with Verteglide and how that is driving scoliosis usage in our business, seeing the early use of 3P hip, we don't have sets out. We'll start deploying sets here in the first part of the year, but seeing the surgeon reaction to that and seeing that, frankly, the price point we're able to maintain for that kind of unique technology and then know, that there are several more technologies that are probably even more significant that are coming down the pipe over the course of the next really 18 months but probably extending over the next 3 years. I'm very pleased with where the pipeline is and, where we're kind of coining this super cycle here. We, we've got some serious products coming and again, I think you'll see some additional spend on the R&D side in different quarters depending on timing.

Okay, that makes sense. And then just want to ask one about, I guess more specifically on Ellie. So, you said first in human, I think, later this year I believe, but what about, pivotal trial or, what's the regulatory process there to get that into the market in the US.

Yeah, so you can imagine we've been back and forth with FDI, the FDA on this topic, similar to the back and forth that we actually quite enjoyed with the FDA on Verteglide, and we're able to come to a conclusion that I think really benefits patients. I think we're at a spot where we're going to be able to, start to generate some revenue and also to generate some data with the Verteglide, here in this year, when it's ready, it's not a huge part of our revenue guide here and based on, I would say relatively short to medium term data we would expect an approval thereafter. And so, I don't know if you want to call this a pivotal, as this was one of our, devices that was, that had the pediatric, indication or the pediatric, exemption so to speak with FDA and I think that, we're in a good spot for a full approval, but it's going to take some patience, and we're going to start collecting those patients and that data here at the back half of this year.

Okay, great.

Thanks.

Thank you. (Operator Instructions)

Ravi Misra, Truist Securities.

Hi, good evening, thanks for taking the question. I have three questions I'll ask them right up front. First, just how should we think about pricing and margin impact given, this new product super cycle that is coming in 2026.

Second, can you just, you mentioned in the last few calls, your MDR strategy, this 4.5, 5.0 approval it's been mentioned a number of times. Just curious. Now how does that kind of allow you to kind of either accelerate or get deeper into the OUS market and then third, just to comment on cardiovascular just recently, just a few minutes ago, how can you think about, if you do get into these adjacencies, the kind of margin profile change that might happen, you're kind of levering up on your, or not levering up, but rather inflecting profitability. How does that kind of, affect that trajectory if you get into kind of non-orthopedic areas. Thank you

Yes, so on the pricing side, as you would expect, these new technologies, are definitely demanding a higher premium, as compared to anything else in the portfolio. So the gross margin, are very attractive. I would say small today in overall revenue when you compare it to the entire business, but over the next several years it will definitely have a positive impact on the profitability of the business. And we're seeing that early days with the technologies today just small so it doesn't really impact the overall metrics, but definitely, when there's technology that is like anything else out there when it's so innovative, it comes with a premium and, we've definitely seen that early days on these procedures.

EUMDR is a great question. It's amazing to me that we're able to sell any products in Europe, when you can only offer one of the sizes. So the 5,560 has been sold and is being sold historically in Europe. We now have the 4,550 that is approved as of last fall, and we have sets in Europe and cases are being done here in January, In February they'll continue to advance, but it's difficult to convert a surgeon when you are asking them to use only one size of our products and you cannot offer a full range of product sizes to meet all of their needs.

And so now we are able to have all the sizes available that they need to convert entirely over to our portfolio and as you can imagine that helps the conversation with converting surgeons in Europe once we have everything available. So very pleased to have that approved. Sets have been shipped and cases are taking place that will continue to ramp over the next many years and add to the growth of the OUS business.

And then as you can imagine on the cardio side, the gross margin profile of that business is definitely much higher than even our implant business. So as a reminder, domestically we get about 85% gross margin on our domestic implant business. The overall is 73 because we're selling outside of the US and many of the sales, about half of our sales US, are going to stocking distributors where we're not paying any commissions, and that goes out at a much lower gross margin rate as you would expect. So the overall cumulative is about 73% for the business. The cardio business as we're just starting to dip our toe in that space, the implant side of that business, particularly in the domestic side, is, higher, I would say than even that 85% that we're getting on our domestic implant business, which is obviously very encouraging and does help the gross margin profile of the business.

Thank you.

I am showing no further questions at this time. I would now like to turn it back over to David Bailey for closing remarks.

Well, thank you all for joining us today on the call, and we look forward to, updating you throughout the quarters of 2026. I think it'll prove to be a very exciting year for orthopediatrics and our mission to, help a million kids a year. So thanks for your time and your interest in our story, and we'll talk to you soon.

Thank you.

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