Great. Good morning, everyone. Tom Steffen with Stifel Med Tech. Really excited to have Orthofix here with us today. Massimo, Julie, Julie, thanks for joining.
Thanks for having us.
Maybe I'll just kick things off, and if you can sort of level set the audience, Massimo or Julie, start by quickly recapping the recent third quarter print and kind of what you view as some of the key highlights.
Yeah, so I mean, I'll let Massimo follow up, but I'll start. Good Q3. Our top line, we beat revenue, beat consensus on revenue, EBITDA, and we're free cash flow positive in the quarter, $2.5 million. Had an accelerating revenue growth rate. Our revenue growth was 6% for Q3 and around 230 basis points of EBITDA margin expansion, which was our seventh consecutive quarter of EBITDA margin expansion. So all around solid performance that we saw within the quarter.
Yeah, and from the commitment that we made since the beginning in all of the areas, so on all of the focus areas for us, we beat the market in a very significant way. So you saw the growth that we had in the United States in spine, which is actually speaking highly about all of the new strategy that we are developing, implementing about distribution. Great growth in the orthopedic side in the United States. BGT keep growing above market, even if we are proudly the leader in the specific category. So I was very pleased about how the company performed.
That's great. Great recap, and we'll certainly dive into some of those dynamics deeper. Want to jump into kind of revenue and some near-term questions. And Julie, I went down this road in Q&A on the call, I believe, but wanted to revisit it and dig a little deeper. I think you mentioned that you beat three Q revs by about $3 million, but didn't raise the midpoint of the guide. So Julie, maybe if you can talk about some of the factors that may have played into that sort of cadence and dynamic.
Yeah, I mean, the primary driver of our beat in Q3 was some stocking orders in international, and so just from a timing perspective, they came in a bit earlier than Q4, we expected them in Q4, they came in in Q3, and so really that's why we're not raising guidance, it was timing of stocking orders. All of our U.S. businesses are accelerating either maintaining growth rate or accelerating growth rate into the fourth quarter, and it was really just that timing of international stocking orders, and then in addition, that was U.S. or international spine on the international ortho side, last year had some stocking orders that will not repeat this Q4, so there's some comparability there too, but it's really all around timing of international stocking orders.
Got it. Okay. So timing of stocking orders in Q3 '25 for OUS spine, and then Q4 '25, you face a difficult OUS orthopedics comp. Is that correct?
Correct.
Got it. Okay. Perfect. Super helpful. And Massimo, you mentioned U.S. spine, so I want to spend some time there. Procedure growth really strong at +10%. Momentum seems to be accelerating. What do you kind of view as durable U.S. spine procedure volume growth moving forward?
Yeah. Our goal is to keep growing above market, and I see that the floor that we have right now is something that we can achieve, given that we need to remember that if you just see our spinal hardware, we still subscale compared to many. There is a confusion between the size of the organization per se and our biggest spinal hardware businesses, and we see each other as a market taker in the space for many years to come. The dislocation that is coming in the marketplace is a positive sign for us. We are commercializing a product line that is very competitive, is very fresh. We talk about our innovation, how we are investing in innovation with Virata to really close the circle and put a bow on a product line that has led us to attract the surgeon and commercial talent out there.
But all of this is still with our philosophy of profitable growth in mind. So at the end, for us to create value, we need to connect the dots between our customer on one side and the shareholder community on the other side. So, EBITDA positive free cash flow has been going to be always our North Star to drive growth.
Absolutely. That's great. Super helpful. So maybe floor on U.S. spine procedure growth, think above market. And Julie, maybe for you, just the other side of that U.S. spine growth equation being price. What about U.S. price? You'll lap the ongoing price headwinds, I think, fairly soon. So how do we think about price contribution to U.S. spine growth moving forward?
So I mean, overall, I think if you look at our long-range guidance, we assume about a 1%-2% price erosion. I think really the reality is, though, I mean, our pricing has really been flat if you exclude the one account that we're in the process of annualizing now. So it's been pretty flat as we've looked at it. But long-range guidance, we kind of assume a 1%-2%.
Got it. Super helpful, and then Massimo, you mentioned this earlier on the distributors, but the targeted distributor transition seemed to be, I'd say, already having a positive impact on the business. What inning are we in with these changes? Or I guess asked another way, how long can this remain as an incremental growth driver for U.S. spine?
Yeah, we are still in the middle of the road. The situation that we found when we start with Orthofix was a commercial organization that's very highly fragmented and has been a mandate for us to start to consolidate, creating start to invest in distributors that can actually scale. It's going to be always an ongoing, let's say, an ongoing work that we have to do in the foreseeable future. I see this strategy divided like this in three pieces. In one piece, in areas where it is very highly fragmented, we consolidate. We are looking at geographic areas where we are not present to go and attract the talent that fits our profile, and we are very diligent on making sure that we don't rush on decision.
And on the other side, now is going to be our goal to make sure that within the top 30, we're going to keep bringing them up, help them to actually scale and to create a stronger partnership loyalty with us. So I'm very excited. We are bringing the 20-plus experience in the space in order to leverage the relationship that we have. And as you said, is paying off.
Got it. That's great. And then maybe to pivot a bit within U.S. spine, just the capital, Massimo, can you talk a bit about 7D placement demand trends and notably kind of what the capital equipment purchasing environment looks like in the U.S. sort of from your perspective?
Yeah, we had a pretty good quarter. We didn't give any numbers, but we just said that we were up compared to last year, so good results there for us. What we are doing in order to be a little bit less, let's say, less sensitive from our overall change of the capital environment, since Julie and I started, we focused really on creating earnout agreements with our hospital. We call Voyager program. So pretty much there is no capital outlay upfront for the enabling technologies, but the enabling technologies getting paid over time with the utilization of implants or biologics. It's very important to us for multiple reasons. A, because we saw that historically the company that leveraged the companies that were able to leverage the capital equipment for earnout has been very successful in both in orthopedics and the spine. So hardware utilization is important.
We believe in the quality of our product, so we start to see that if the 7D, when we close an earnout contract, the overall utilization of our implants in the account increase. I said that we said that in aggregate, all of the accounts that have 7D available, they are 50% up from what their commitment purchase, so a great indication of the quality of both of the 7D and our implant, and lastly, it's a good indicator for all of you because if the earnout goes well for implant, always means that it's a new account for us, and now with biologics, if we have a strong presence in the account, we can add the biologics together to as a pull through, so 7D strategy, I think that we can clearly say that it's paying off.
Got it. Makes sense. And then last one here, just on capital equipment. Are hospitals kind of shifting their purchasing mindset to sort of those types of selling programs, maybe more with earnouts? Are you hearing that from customers that that's sort of preferred relative to outright purchase?
I think that it really depends from it's twofold. A, depends of the account. Of course, some of them, it depends from the account and the experience that they had in the past. Within the Voyager program, what we offer, for instance, that is different from others, we have free software updates. We are very responsive and we don't charge for maintenance that we need to do on the machine. Other competitors actually do creating some kind of sour taste on some of the sometimes on the accounts where we try to go. So I think that is highly dependent on the previous experience that they have and, of course, of their financial situation.
But what we have in our favor is what I just said, that knowing the experience that they had in the past, we are not just competing with that technology, but also we are competing with our ability to create a very smooth experience with our program for all the accounts. So between the surgeon support and the fact that we are thinking also not just with the surgeon, also we are thinking about the administrators that they need to manage the programs. We are seeing a very good reception of it.
Got it. That's great. Super helpful. Wanted to spend some time on Virata. And Massimo, maybe I'll stick with you. Just to kick things off here, maybe if you can briefly explain to us the value proposition of Virata and its key points of differentiation.
So first of all, Virata is the first product that we are launching that was fully designed with 7D with the experience with 7D in mind. So as every enabling technology platform, 7D is an open platform. But when with Virata in mind, we designed the system in a way to create a much smoother user experience in the OR. From the technical perspective, besides the differentiation in the screw design, Virata is like the sum of multiple areas of experience in the space on designing this kind of system. And it's been interesting to me to see that during the alpha launch, we target just new account. And so we did that for obvious reason. A, to start to make sure that we increase our surgeon pool. But from the alpha perspective, we want to make sure that surgeon with different experience had a better experience with Virata.
Again, the results so far have been fairly positive. From the operational side, from the clinical side, during the merger between SeaSpine and Orthofix, Orthofix had a specific patent, a specific IP around the screw heads and the locking mechanism of the screw heads with the shank. What it brings on one side in the OR lets the surgeon the ability to change and game plan during the case, which kind of tool to use. From the company perspective, from the hospital perspective, we shrunk the amount of screws and so the volume of sets that we need to have in the OR. I'm very excited because for these three reasons. A, the fact that it's going to keep validating the quality of 7D.
B, the differentiation that is going to give in the OR to the surgeon to game plan and make real-time decision for the best for the patient and C for the decrease of cost to serve that we're going to bring with an item that is the most widely used device in the OR. Every time you have a fusion, a lumbar fusion, you always have a pedicle screw.
Got it. Super helpful there. And just in terms of the launch roadmap, so currently in the alpha launch, what does that entail? And then kind of where do you go from there to ultimately get you to the targeted H2 26 full launch?
Yeah, I think that the vast majority of the time is going to be just the waiting time to receive the instrument set. So we're going to close the alpha end of this year, 30-45 days to redesign. And now it's going to be the time to place the order. So it's going to be just a waiting time to make sure that we have the inventory available in-house.
Got it. Okay. And so I guess with that in mind, do we think about Virata as more of a 2027 incremental driver, or can it maybe start to help drive growth incrementally in the second half of 2026? Maybe for you, Julie?
Yeah. So it will definitely drive growth in the second half of 2026, but 2027 will have the full year impact. And so I think it will accelerate into 2027.
Got it.
Also to think about Virata is a multi-year development program. Right now, what we are launching is the alpha launch. It just focused on the open market, which is the lion's share of the overall spine market. In the beginning of 2026, while we are going to manufacture the set for Virata open, we're going to start alpha for the MIS version, which is going to be launched, you can infer in 2027. In 2027, we're going to start the alpha for the deformity version that is going to be launched in the following years. So it's a big program for us. It's a great investment that is going to bring sequential growth, sequential catalyst for us in the spine side for multiple years. Yeah.
That's great. Maybe to pivot to kind of 2026 or I guess sort of stick with 2026. Julie, no, you're not guiding, but maybe if you can talk about just kind of key puts and takes as we think about revenue next year.
Yeah. So I think we see we're setting ourselves up to have a positive year next year. I think the Virata launch mid-year. It'll be our first full year of TrueLok Elevate and our FITBONE. And then, of course, the distributor transitions that we did this year will have a full year impact from those as well. So we see that we have a lot of tailwinds going into the year. I think it takes. I'm going to say, I think we've done as much as we can to de-risk the number if there's external factors as price or something like that, but beyond that and timing of product launches, but we feel good about going into next year.
Got it. That's great. And wanted to kind of drill in deeper on one sort of new dynamic we're getting more familiar with, but for bone growth therapy, believe there were some CMS changes that potentially could have an early impact early next year. Julie, can you explain what this is and maybe how we should be thinking about that in the context of BGT revenue next year, notably in the first quarter?
This, Julie, will take that.
Yeah, Julie, do it.
So CMS is implementing a pilot program in January in certain episode of care categories, BGT being one of them. We expect, though, the annual impact for us will be immaterial based on what we've seen. And importantly, I think we don't expect it to change physician prescribing behavior at all, which would be a real impact for us. So no impact on physician prescribing behavior. And hospitals will just manage the timing. CMS occasionally does these programs. Hospitals have had to deal with this before. So immaterial impact on an annual basis for us next year.
Okay. Great. Super helpful. And then I want to move to kind of margins and profitability. And I'll start on gross margin. The 2027 financial targets included the goal of, I think, 300 basis points of GM expansion. To kick things off here, talk about kind of key drivers of that.
Yeah. So there's three primary key drivers that we've talked about. One of those is supplier consolidation. And they're primarily targeted towards our spine margins as that's where we're below industry norms. And so from a spine perspective, supplier consolidation, I think as the organization has grown, has not necessarily been strategic in its supply base. And so we're working through that. It's been very transactional, just PO based. So we're working through narrowing our supply base, going through contracting, getting volume commitments and volume discounts. The second thing is insourcing our warehousing and distribution, which has been outsourced for the spine business and really not the ability to leverage economies of scale there. So we're insourcing that and consolidating that with our facilities in Dallas, Texas area.
And then the third is insourcing some screw manufacturing to our manufacturing facility that we have for our Orthopedics business in Verona, Italy, and seeing some economies of scale and some reduced costs there. And then really kind of underlying all of that is some mixed benefit we expect to see as well from growing the U.S. business, and particularly the domestic U.S. business, much faster than the OUS business.
As a follow-up to that, between U.S. and OUS, is there a rough way to think about kind of the gross margin differential there?
I mean, we don't necessarily break that out, but I would say just say generally speaking, you're probably going to have a 15-plus% margin difference between the two.
Got it. Got it. Okay. Great.
Even how we go to market, the cost to service is still comparable.
Got it. Okay. Okay. Makes sense. Maybe working my way down the P&L. Midpoint of 2025, adjusted EBITDA guidance, hopefully I have some numbers correct. I think implies 10.5% for full year 2025. You're targeting mid-teens by 2027. So let's say that's 15% on the low end or at least 200 basis points per annum. That's above this year tracking toward, I think, 100 basis points on a pro forma basis year over year. So we just discussed gross margin. I think a lot of levers, but broadly speaking, talk about your level of confidence in achieving this 2027 target.
Yeah. So I mean, on a pro forma basis, yes, 100, but I think we took action and part of the discontinuation of M6 was to improve our EBITDA profile. So if you look at it kind of from that perspective and where we started, it's going to be around 200, a little over 200 basis point EBITDA margin expansion. And so I think, again, we're going to see the flow through from the gross margin expansion. We'll be a little less than 100 basis points on that this year. So that's going to be contributing as we go into 2026, 2027, a little above what we've seen this year. We're exiting at 72%, so 100 basis point improvement on our exit, but not for the full year print.
And then we really believe that from a leverage perspective on our SG&A, excluding commissions, marketing costs, those types of things, that we really have the organization that we need to be able to scale to a much larger revenue number. So we expect that leverage to pull through as well.
That's great. And as a follow-up to that, Massimo, we talked about the distributor transitions. I think there's a lot of top-line benefits there, and we've seen the top 30 distributors really performing strongly. Talk about the margin impact from the consolidation, from your actions with the U.S. kind of commercial footprint?
I don't think that we don't talk about this.
Yeah. I mean, I would say it's generally less of a margin impact and more of where you'll see efficiencies is on working capital and set deployment because they're much more efficient typically with your assets than having a lot of small non-scale distributors. So that's where you see the impact is more on the working capital and set utilization side.
Yeah. Because while I made the comparison with what we do internationally, while internationally, they buy the instrumentation, the instrument set and the implants. Our distributors in the United States, the instrument set is our asset that we give to our distributor to perform the procedure. This is why I think that the real benefit for us, and I keep talking about scale, is because now you can do a higher amount of surgeries with less asset that you pretty much mobilize just for the specific distributor. So what we like of the strategy that, again, is connected also, not just on growth, but also on profitability.
Got it. That's great. And then maybe last one on margin. So the 2027 adjusted EBITDA margin goal, Julie, how do we think about the path to getting there between 2026 and 2027? Is linear a reasonable assumption? Is it weighted more toward a certain year? Just curious, as we kind of figure all these inputs, what's kind of timing of that pathway?
Yeah. I mean, we expect it to be weighted a little bit more towards 27. We've said that kind of since the beginning just because some of the gross margin initiatives are a longer tail. Think about the supplier consolidation. That'll be mid to late next year when we get that fully implemented. And so again, that'll be a 2027 impact. So a little bit kind of back and loaded in the timing.
Got it. Makes sense. Maybe to pivot in the last couple of minutes, I'll try to squeeze one or two more in. Orthopedics, we haven't talked too much about. Massimo, your outlook for that business, and I'll drill in with a more specific question. Do you believe a growth acceleration next year on the top line is within the range of outcomes as we think about TrueLok being more incremental, other new products? What's kind of, let's call it the intermediate to long-term outlook for the Orthopedics business?
Look, I see that for sure the business is not decelerating, the one I can tell you wholeheartedly. And mostly because what you just said, I'm very bullish about what we're doing there, given that we identified a specific segment of trauma where we can actually have a meaningful product differentiation. We are the only company with internal external system to address all of these complex cases. We identified within these $2.6 billion opportunities, this segment of curing diabetic foot with our TRULOC Elevate. And so between the investment we're doing on a FITBONE, between all of the work that we're doing around this market creation around Elevate and all of the work that we're doing there commercially, we are building up a team of leaders that actually manage a multi-billion dollar franchise in the past. I think that we have a great opportunity there.
That's great. That's great. And this might be a good segue into the last question I have, and we have about a minute. But Massimo, just to wrap things up, I mean, what do you think is the most underappreciated part of the Orthofix story or parts, if there are many in your view?
I think what we are facing right now is this underappreciation of a company that coming out from pretty difficult years was able to really change the foundation of the business. The improvement that we did on free cash flow is remarkable. All of the continued beating our expectation on EBITDA, I think that is seven quarters that we keep delivering it. The fact that our portfolio is built in a way that can let us go in the account from a multiple point of access. The fact that we can grow in a bull market without a big depletion of our capital is kind of something that I think that is highly underappreciated.
I think we have everything available to show the market that our technology can win, our focus strategy can win, and that we can do everything with, in mind, is a profitable growth mantra.
That's a great note to end on. Massimo, Julie, Julie, thanks so much.
Thank you.
Thank you.