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On Tuesday, 11 November 2025, Orthofix Medical Inc. (NASDAQ:OFIX) presented its strategic vision at the UBS Global Healthcare Conference 2025. The company outlined its financial recovery and growth strategy, focusing on innovation and market expansion. Orthofix emphasized its commitment to the spine market and bone growth therapy, while also addressing industry challenges and opportunities.
Key Takeaways
- Orthofix aims for a 6.5-7.5% net sales CAGR through 2027, with mid-teens adjusted EBITDA.
- The company has turned its free cash flow from a $109 million loss to positive.
- Orthofix is launching the Virata and TruLock Elevate systems in 2026.
- The 7D Flash Navigation system is a key driver of growth and market differentiation.
- Orthofix is capitalizing on industry consolidation, with opportunities arising from competitors' strategic shifts.
Financial Results
Orthofix reported significant financial improvements, marking seven consecutive quarters of positive EBITDA since the leadership of CEO Massimo Calafiore and Head of Investor Relations Julie Dewey. The company achieved a dramatic turnaround in free cash flow, moving from a loss of over $100 million to positive figures. Despite a projected 1%-2% price pressure, Orthofix plans to offset this with volume increases.
- International spine fixation grew 86% in the third quarter.
- Top 30 U.S. distributor partners saw a 25% year-over-year net sales growth, with a 33% increase over the trailing 12 months.
Operational Updates
Orthofix is optimizing its distribution network and expanding into new territories to enhance market presence. The company is focusing on specific subcategories within the spine and orthopedics markets to achieve leadership positions.
- The 7D Flash Navigation system strategy shifted to an earn-out program, boosting account volumes by 50%.
- Efforts are underway to improve capital efficiency, enabling more surgeries with the same capital investment.
- TruLock Elevate is in its early stages, focusing on market creation and education in limb reconstruction.
Future Outlook
Orthofix is setting ambitious goals for the coming years, aiming for sustained growth and innovation. The company is preparing for major product launches and enhancements in 2026.
- Virata thoracolumbar fixation system will be fully launched in 2026, with its MIS version in alpha launch.
- TruLock Elevate will see a full launch in 2026, with subsequent versions planned.
- Q1 2026 will introduce pre-operative planning and custom patient-specific roles through 7D.
- Catalyst devices are set for short-term release.
Q&A Highlights
In the competitive landscape, Orthofix sees opportunities arising from Johnson & Johnson and Stryker's strategic sales. The company believes surgeon preference remains crucial over contractual obligations.
- No significant changes are expected in payer policies for Bone Growth Therapies.
For more detailed insights, readers are encouraged to refer to the full transcript below.
Full transcript - UBS Global Healthcare Conference 2025:
Danielle Leontofsky, U.S. MedTech Analyst, UBS: Right. Good afternoon, everyone. Thank you for joining us. I'm Danielle Leontofsky. I'm the U.S. MedTech analyst here at UBS. Very honored to have with us Orthofix Medical. We have President and CEO Massimo Calafiore. We have—well, no, we do not have the Chief Financial Officer. I was reading off that. We have Julie Dewey, Head of Investor Relations. Unfortunately, Julie Andrews, Chief Financial Officer, could not make it because of travel issues. I think we got it covered with the folks on this stage. Massimo, maybe give a minute or two, or five, whatever you need, to give a quick overview of the business for folks that might not be as familiar with Orthofix.
Massimo Calafiore, President and CEO, Orthofix Medical: Orthofix is a MedTech company focused on the spine market, on both bone growth therapy market, biologics, and orthopedics. We are a pretty competitive portfolio. We started this journey two years ago with the idea in mind to make sure that we would utilize all the commercial synergies that we could of the portfolio that we had, while at the same time funding specific pockets within this broad market where we compete, where we can win, but with in mind this idea of profitable growth and free cash flow creation. In the spine vertical, we are still subscale, but a pretty strong portfolio with a clear innovation strategy.
We have a very competitive and highly differentiable enabling technology platform that is 7D, that is helping us to create strides in the market and compete with the largest players in the market, but also at the same time creating a lot of room for us to grow, dislocating a lot of the small companies that participate in the spine. Within the spine portfolio, we cross-sell our biologics portfolio, which is where we have pretty good market share in some subcategories. On the opposite side, in orthopedics, we did a very good job narrowing our focus on a specific subcategory that is the limb reconstruction market. In this specific market, we enjoy a portfolio that is highly differentiable.
If you see in between, we are taking advantage of the commercial synergies that we're seeing between the bone growth therapy portfolio into spine and the bone growth therapy portfolio into trauma. Let's say a very well-balanced and diversified company focused on value creation.
Danielle Leontofsky, U.S. MedTech Analyst, UBS: Okay. Got it. Since you and Julie joined back in 2024, you've made a lot of progress on solidifying the foundation of Orthofix. Maybe talk about the progress you've made thus far.
Massimo Calafiore, President and CEO, Orthofix Medical: Yeah. At the beginning, when Julie and I started, first thing first was we needed to solidify the base, the financial base of the organization. We worked very hard to refinance our debt. There was a big overhang for us, very successfully. We turned around the free cash flow generation for the organization. When we joined the year that we joined the company, we lost more than $100 million on free cash flow.
Danielle Leontofsky, U.S. MedTech Analyst, UBS: $109 million, to be exact.
Massimo Calafiore, President and CEO, Orthofix Medical: Now, let's say we have free cash flow positive. And since we started, we have seven quarters in a row of positive EBITDA. That one, great. Second was, okay, everything happened, you need to have a strong team around you. We hired. We created a brand new management team, all people that have specific experience in the spaces where we compete. We believe that in spine orthopedics, you need to have people that know the market, kind of to understand the nuances. Third, we defined a pretty clear innovation agenda focused on 7D, our enabling technology platform, refining the portfolio in spine, and funding this area where we can differentiate it very much as in orthopedics. Finance first with people, and now focus on execution with innovation and growth.
Danielle Leontofsky, U.S. MedTech Analyst, UBS: On that point on execution, you actually did have a pretty solid third quarter that you just reported. Can you give us some of the highlights from the quarter? I think one of the questions investors have had is, with a quarter like that, why didn't you raise revenue guide?
Massimo Calafiore, President and CEO, Orthofix Medical: Okay. From the quarter, as you said, was very well executed. In every single area, we enjoy growth well above the market, starting to take the benefit of all of the choices that I mentioned before, together with the work that we're doing on optimizing our distribution network. I was very pleased about how the organization performed. The beat in Q3 was mostly due to some timing related to some international order that came earlier than expected. We decided to maintain the guidance for Q4 as it was just because of the timing of these specific orders.
Danielle Leontofsky, U.S. MedTech Analyst, UBS: Understood.
Massimo Calafiore, President and CEO, Orthofix Medical: Nothing earth-shattering, but again, I was very, very pleased about the quarter.
Danielle Leontofsky, U.S. MedTech Analyst, UBS: Great. Let's talk about the spine business. So it sounds like you are very excited about the upcoming Virata—Virata, am I saying that correctly?
Massimo Calafiore, President and CEO, Orthofix Medical: Yes, Verada.
Danielle Leontofsky, U.S. MedTech Analyst, UBS: Virata launch in spine. Can you talk about what differentiates the platform and what can we expect as it relates to the launch, the ramp cadence?
Massimo Calafiore, President and CEO, Orthofix Medical: We are very excited because if you see the portfolio of all our competitors, Thoracolumbar Fixation is one of the highest, if not the highest revenue generator. Within the portfolio that we found in Orthofix, this area was the area that still needed some innovation coming. Great work of our engineer on developing a record-time Virata, which pretty much encompasses year-on-year of history in spine around this type of product. Just to give you a couple of examples, during the Alpha launch, we targeted just surgeons that did not have any relationship with Orthofix. Because we start to see, okay, what are the systems out there? We start to bring and improve the philosophies that we already utilize, a very easy transfer between us and between them and us on the product side.
Also, during the merger, the company inherited a pretty strong patent for a specific feature from Orthofix, which is the ability to pop the head of the screw in the shank. What it does, it creates a lot of opportunity for the surgeon to interoperate during the operation, decide which kind of screw to use, just picking, let's say, this specific feature. B, we are creating a very big operational efficiency for us because the amount of inventory that we need to send in order to perform the case is much lower. A lot of excitement for three reasons: the ability to now fully compete in the largest market in spine, B, more operational efficiencies for us, and three, the ability to, over time, keep addressing different areas of the fixation space because right now, this launch of Virata is just for the open platform.
We're going to have DMIS coming and third, deformity. So a multi-year journey on this product.
Danielle Leontofsky, U.S. MedTech Analyst, UBS: Okay. Gotcha. In the third quarter, your top 30 U.S. distributor partners grew net sales 25% year-over-year, 33% trailing 12 months following targeted transitions. What further transitions remain there? What near-term disruption or uplift could we expect into fiscal 2026?
Massimo Calafiore, President and CEO, Orthofix Medical: Yeah. We're going to—we're always going to—all the company and us especially, we're going to look—we're going to be very critical about the quality of the partners we have and the ability of the partners that we have to scale. We are just kind of at the middle of the road of our journey. How strategically we go about our, let's say, commercial strategy is in some areas we consolidate. We bring—we eliminate some smaller shops to consolidate to a bigger partner where we see, let's say, a little bit more time to uplift because you need to start to—there is some transition period that needs to be managed. There are a lot of new revenue coming because there are many areas of the country where we're not present.
We are taking advantage of some of the dislocation that you see with our competitor, taking advantage of larger distributors that are available for us. A twofold strategy that is not just bringing this accelerated growth for us in the top line, but also helping us to maximize the utilization of our asset. The strategy is creating not just top-line benefit, but also better cash flow utilization and EBITDA creation for us.
Danielle Leontofsky, U.S. MedTech Analyst, UBS: Sure. Sure. International spine fixation grew 86% in the third quarter. How much was driven by new geographies, channel restructuring, or non-recurring tenders? What is a normalized growth cadence for that business?
Massimo Calafiore, President and CEO, Orthofix Medical: Yeah. I think that we're going to keep growing in the foreseeable future, not at the same rate, but a pretty accelerated rate. It's driven by a couple of factors. A, we are being very strategic about how we're going, especially into Europe, focusing on markets where we still can enjoy decent pricing. And we're doing very good and efficient work to re-up our MDR certification for the product out there. A good opportunity is coming from the defocusing of international from some of our competitors. Also, now, we are starting to focus on APAC and the Middle East, where we can have pretty competitive pricing and with product that surgeons enjoy as much as the United States. It's been a surprising quarter, but I think that we can—an area where we can grow still in a profitable way.
Danielle Leontofsky, U.S. MedTech Analyst, UBS: Okay. Okay. What about the sales force here? Should we expect the sales force to grow meaningfully, or do you think you've reached critical mass to support your current growth expectations?
Massimo Calafiore, President and CEO, Orthofix Medical: Just to give you, just to level set here, in spine and orthopedics, we use just distributors.
Danielle Leontofsky, U.S. MedTech Analyst, UBS: Distributors, right.
Massimo Calafiore, President and CEO, Orthofix Medical: In bone growth therapies, 50/50 between direct sales force and distributor. On the distributor side, we are subscale in both segments that you mentioned. I think that there is still a lot of opportunity to grow and a lot of partners out there that are asking for competitive technology, that competitive technology that we have. I think that from the growth perspective, it's mostly in our hand to make sure that we do not deviate by our strategy of profitable growth. We are going to keep improving how we go to market. We are going to keep improving the quality of our partners in a responsible way, but a lot of room to grow there.
Danielle Leontofsky, U.S. MedTech Analyst, UBS: Okay. Earlier this year, you did have a U.S. spine price decrease at a major account that should now mostly be anniversary or annualized, and you are trending towards flat ASP. How are you thinking of the balance between price and volume to protect ASPs in 2026?
Massimo Calafiore, President and CEO, Orthofix Medical: Yeah. We are expecting that in our long-range business plan, we expect 1% or 2% price pressure. I think that we can overcome with the volume increase. What's happened this year was just a coincidence of a merger between two accounts. Kind of not really market macro, not driven by a macro environment, which at price level, if you think since post-COVID, has been pretty stable in orthopedics and spine.
Danielle Leontofsky, U.S. MedTech Analyst, UBS: Yes. Totally fair. Let's shift to orthopedics and limb reconstruction. You're the only U.S. company offering a complete suite of internal and external limb reconstruction solutions. Where are you on the adoption curve for TruLock Elevate and FitBone Nails? What does the ramp into 2026 look like by procedure type?
Massimo Calafiore, President and CEO, Orthofix Medical: We are still at the infancy, especially on TruLock Elevate. It's a market creation activity. A lot of education at surgeon level, a lot of education at rep and distributor level around the procedure. We have what we call a vital few, so clear priorities that were set in the organization for 2026 about developing the full go-to-market strategy for this product. We are foreseeing to be a growth driver for 2026 and beyond. At the same time, on the internal lengthening, a lot of opportunities that are coming to us because the focus on this market segment from our large competitor. I personally like what we are doing in orthopedics because we found this $2.6 billion market where we can clearly be the market leader.
On top of this, going back to about pricing, we compete in an area that is less price-sensitive than everything else. Our patient population is very demanding, so less attention on the cost. A great opportunity with very good margin.
Danielle Leontofsky, U.S. MedTech Analyst, UBS: Okay. Within this business, what are the key barriers to surgeon adoption of deformity correction and bone transport? How are you scaling training programs to accelerate conversion?
Massimo Calafiore, President and CEO, Orthofix Medical: Yeah. In our vital few, education is important. One thing that we are doing, we are focusing—before, the company was very focused on podiatrists and EPA. Now we are starting to work in a more diligent way on partnering with institutions around the United States that are actually focusing on limb reconstruction. This one is going to give us the opportunity to start to meet fellows and residents that are about to go out in the market. They're going to go in the market in the future. We are doing a very good strategy to create not just a strong foundation for this business, but also longevity in the business. Clinical education, clinical publication, and fellow, resident, and fellow strategy is key for us to succeed.
Danielle Leontofsky, U.S. MedTech Analyst, UBS: Is it part of fellowship training programs?
Massimo Calafiore, President and CEO, Orthofix Medical: There are just a couple that are starting to focus. One actually in New York City in HSS.
Danielle Leontofsky, U.S. MedTech Analyst, UBS: Okay. Okay. Let's talk about enabling technologies and 7D Flash Navigation. Can you share the latest placement cadence and utilization for 7D Flash, building on the record placement year you had in 2024? What is the roadmap for software modules, imaging integration, or robotics partnerships here?
Massimo Calafiore, President and CEO, Orthofix Medical: Okay. So let's start from the innovation side, which I like. We spend around 8% in average of R&D per year, and there is a lot of investment that goes into feeding 7D. We have a great group of engineers and the ability to release—we have a very good cadence of software release on the system that keeps increasing the usability of the system and keeps increasing the number of devices that we can navigate on the system. A good innovation coming there. At the same time, we are laser-focused on keeping changing and keeping innovating within the space of navigation. Excited about what we can do there from starting from a platform that, as it is today, is highly differentiable. All of this is translating on clear commercial success.
One of the things that we did since we started to run Orthofix, focusing on enabling tech, we changed our strategy from straight capital sales to start to leverage the earn-out program that we call Voyager. We did this for three reasons. A, because I believe in pull-through. If you see all of the companies that were successful on leveraging enabling tech, they create a real pull-through for the hardware. B, I truly believe that we had already a very highly differentiable portfolio to sell in spine. We needed 7D and a strong commercial organization to give this portfolio a voice. I believe in the quality of 7D. Just to give you a sense of the success in aggregate, the accounts that use, that have 7D at their disposal, they have 7D available with them.
Their earn-out program is 50% ahead of their volume commitment. This one is a great testament about the quality of the product and the quality of the implants that we have.
Danielle Leontofsky, U.S. MedTech Analyst, UBS: Right. Just on that point, what is the average? That was one example, and you're doing very well with that account. What is the average implant biologics revenue uplift per account post-7D Flash installation? How does that influence capital allocation to enabling tech versus instrument sets?
Julie Dewey, Head of Investor Relations, Orthofix Medical: We have not provided a specific amount of that uplift. What Massimo just said in terms of the aggregate, it is pretty compelling in terms of what it can do. That is very sticky, I would say very sticky revenue in terms of that. We love doing these Voyager agreements all day long.
Danielle Leontofsky, U.S. MedTech Analyst, UBS: Yeah. Yeah.
Massimo Calafiore, President and CEO, Orthofix Medical: On the capital allocation, it is one area where we improved a lot since our tenure. Mostly because what I said before about the type of partner that we are using, we can do a larger amount of surgery with the same amount of capital that we invest. Very pleased about the progress we are making there.
Danielle Leontofsky, U.S. MedTech Analyst, UBS: Okay. Let's talk about bone growth therapies now. You were 6% in Q3 with above-market performance and traction in fracture. What is the mix of growth from competitive conversions versus new surgeon ads? What is the multi-year runway for ExcelStim?
Massimo Calafiore, President and CEO, Orthofix Medical: Yeah. We do not give a specific statistic around that. What I can tell you is we have been very successful on creating synergies between the commercial organization into spine with the commercial organization in bone growth therapy. This is why you see that despite the clear market leadership we have, still growing 6%. And if you see how sustained was the growth since the tenure in the specific segment, it is a big testament about the discipline that we are bringing on the execution of the organization. On fracture, it is a little bit different because we can manage the growth also, keep investing on direct sales force. So very pleased about how the team is performing. Access Team per se is an. We already have the same method of delivering care in our portfolio.
What 2.0 is going to bring to us is going to be an uplift on our margin, given that right now we're going to start to manufacture the product in-house that we license.
Danielle Leontofsky, U.S. MedTech Analyst, UBS: Okay. Maybe talk about payer policies here and what are the potential mitigation strategies should CMS revisit prior auths or HCPCS changes for this class in both groups?
Massimo Calafiore, President and CEO, Orthofix Medical: Yeah. Yeah. We don't expect big changes on macro level. The system has been very stable for BGT. And we are protecting our market leadership with our PMA. We are the only class three device. And we didn't see in the recent history, in the recent past, any pushback or sign of the classification of our technology. So pretty pleased there.
Danielle Leontofsky, U.S. MedTech Analyst, UBS: Okay. Gotcha. Let's shift gears to the pipeline and R&D and how you think about the cadence of product launches. Specifically for 2026, what's on the docket there? You've got Virata that sounds like will go into full launch in 2026. What's coming behind Virata from a product launch perspective?
Massimo Calafiore, President and CEO, Orthofix Medical: Yeah. On the Virata side, it's just going to be just the open platform that is going to go into full launch in 2026. We're going to go on Alpha Launch early in 2026 with MIS. On the Virata side, it's a multi-year product development. A catalyst, we're going to have different catalysts coming in the short term. Very excited about that. We need to keep commercializing all of the latest innovation interbody. We have our Reef technology that we use for lumbar for anterior support, anterior column support that is still in the infancies of the launch piece. A clear strategy on spine. On the orthopedic side, we're going to get Elevate.
It's going to be fully launched in 2026, but similar to what I said to Virata, you're going to see different versions on Elevate coming in the horizon year over year. It's a market segment that we are creating. It's a market segment where we want to keep winning and growing. A great focus on that. FitBone is another area where we are investing a good amount of resources in order to complete and evolve the product line. Clear 7D, we talk about it. We want to own the continuum of care. Not just focus on what's happening in the OR. Q1 of 2026 is going to give access also to pre-operative planning and custom patient-specific roles that we're going to launch. In BGT, keep leveraging our strong market position to collect data.
We have award-winning STIM on Track platform that lets us not just manage patient compliance, but also collect data that over time you can feed into the system. If you go segment by segment, we have a pretty clear innovation agenda.
Danielle Leontofsky, U.S. MedTech Analyst, UBS: Yeah. Yeah. Sounds like it. Let's talk about the long-term targets that you guys have provided. To level set everyone, 6.5-7.5% net sales CAGR through over 2025 to 2027. Mid-teens adjusted EBITDA by 2027, sustained positive free cash flow. As we look forward, what are the catalysts that support you achieving this goal? Where do you see the biggest risks?
Massimo Calafiore, President and CEO, Orthofix Medical: From the opportunities, I think that is clear. We are working, keep working on how we go to market. We keep working on our product, on our very deliberate product launch cadence. So a lot of excitement of what is going to happen late this year, late of 2026 with Virata and the full we are expecting to enjoy the full year of launch of Elevate. From the risk perspective, I think that the market is pretty healthy on macro level. I think that we're going to have we already talked about the tariff effect that we're going to have in our P&L, which for us is highly manageable given that we have just a little exposure in Europe with orthopedics. So I think that Orthofix story now is a story of relentless execution and keep improving on what we discussed on the commercial side.
I'm very pleased about the discipline that the company has. We beat, we were growing EBITDA constantly, quarter over quarter, together with all of the other metrics. Excited about what we can do.
Danielle Leontofsky, U.S. MedTech Analyst, UBS: Yeah. I think something that's top of mind for investors as well is what's happening in the competitive landscape with, so Johnson & Johnson is now spinning, selling their orthopedics business. Stryker sold their spinal implants business. What are you seeing out there? How's the competitive landscape changing? Is it impacting your go-to-market strategy at all?
Massimo Calafiore, President and CEO, Orthofix Medical: For us, it's just opportunity.
Danielle Leontofsky, U.S. MedTech Analyst, UBS: Disruption.
Massimo Calafiore, President and CEO, Orthofix Medical: It's a clear sign that the market is demanding companies that are focused on the surgeon, that are focused on surgeon needs from the technology perspective, from the service perspective. I think that the surgeon and distributor like to partner with nimble companies that have one mission in mind. It's interesting. If you go back a few years ago, all of these big competitors had this idea to invest in a multiple, this desperate market, a different type of market in order to try to own specific accounts on multiple levels. You start to realize today that surgeon preference is still more important, sometimes the contractual obligation.
When you start to learn that, I think that on a macro level, there may be not interest to participate in a market like spine and orthopedics, which is a great opportunity for us and a great opportunity that we're going to take advantage of. At the same time, the fact that we own this enabling technology platform like 7D is creating differentiation in spine from all the smaller competitors. You do not start to see consolidation or dislocation at a macro level, but also for sub-under $1 million company. Good opportunity for us.
Danielle Leontofsky, U.S. MedTech Analyst, UBS: Let's maybe talk about capital allocation. What are your priorities when it comes to capital allocation?
Massimo Calafiore, President and CEO, Orthofix Medical: We are investing. R&D innovation is important for us. In our 8%, I think that we can, it depends on our priorities. We are very disciplined on how we invest capital. 7D is important. It's a differentiated platform. A lot of focus there. Within the market where we compete, this is why I said that one of the works that we did is really focus on areas where we believe that we can win. The Limber Ecostra before, Orthopedics, where Orthofix were participating on different segments of trauma in order to optimize capital allocation, area where we can win. We decided to win there. In spine, there are two, three areas where we can be highly differentiated, like cervical, now Virata with thoracolumbar interbody. Somebody asked me a few weeks ago during a podcast, how can, despite our size, how you can win in innovation.
I think that you can win just through prioritizing and be able to say no instead to say yes to everybody. This is what we did. We discontinued more than 40 product lines. We discontinued a large product line that was a headwind for us. We are consolidating distributor. All of this just to create the discipline that led us to invest and win a specific area of innovation.
Danielle Leontofsky, U.S. MedTech Analyst, UBS: Okay. In the last minute here, I'd like to wrap up by asking, where do you think there's dislocation between what investors are either focused on or how they perceive Orthofix versus what you think Orthofix is delivering and can deliver?
Massimo Calafiore, President and CEO, Orthofix Medical: Yeah. I think that there is a disconnection between, I think that people need to, and investors need to step back one second and see what is the history of Orthofix and where we are in the continuum of our growth strategy. Sometimes we are compared with companies that are 10, 12 years ahead of us on the execution side. We are just in two years in our journey. If you see just the amount of progress that we made since the beginning of our tenure, it's astonishing. The difference between the company that we inherited and the company that we are now. I don't think that we get enough credit of innovating and growing, creating profitability, still being subscale on many markets where we compete. I think that it's going to be a great story from now on.
Danielle Leontofsky, U.S. MedTech Analyst, UBS: With that, we're at time. So, free timing. Thank you, guys.
Julie Dewey, Head of Investor Relations, Orthofix Medical: Thank you.
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