Good morning, everyone, and thank you for joining us at this year's Canaccord Genuity Musculoskeletal Conference. My name is Caitlin Cronin, and I'm on the medical device team here at Canaccord Genuity. I'm here with Orthofix, a global medical device company specializing in differentiated orthopedic and spinal solutions. We are very pleased to be joined today by Massimo Calafiore, CEO; Julie Andrews, CFO; and Julie Dewey, Chief Investor Relations and Communications Officer. Before we begin, I want to remind everyone of any relevant disclosures, which can be found on our conference and our firm website. We will begin with a brief presentation from Massimo, followed by a fireside chat. I will try to leave time for a few minutes for questions from the audience. With that, I turn it over to Massimo.
Thank you, Caitlin. Good morning, everybody. Thank you for having me here, having us here. Thank you to all of you to be here to hear our story. Just to start, our usual forward-looking statement, so you can read it at your leisure. For who is not familiar about Orthofix, we are a global med tech company founded in Italy in 1980. Now we are globally in more than 50 countries, 1,600 employees. As Caitlin said, we are very differentiated in different business segments. The majority of our revenue comes from our spine vertical, spine biology, biologic products, and enabling technologies. We have a very successful bone growth therapy business and orthopedics. Orthopedics is the, let's say, from where everything started in Orthofix in 1980. We have some different offices worldwide, but our headquarters is in Lewisville.
We enter in a very successful Q4, a Q4 that was a culmination of our ability to execute quarter- over- quarter since we took the leadership of the organization. Just to give you some time reference, I'm in role just slightly more than one year, like Julie joined me right after. It's been a pretty fast journey in the first six months to build up the leadership team that is in place right now. As Q4, like we did in the previous quarter, working together, all of the businesses grow, way faster than the market, so great success in all of the different verticals. At the same time, what we show is a great responsibility on managing the business, so a very healthy free cash flow generation, an increase of EBITDA, that our EBITDA keeps increasing much faster than our revenue.
Not just, let's say, we were able to, in just four quarters, deliver what everybody that is investing in Orthofix wants to see. A company can change patient life day in, day out, but at the same time, create real value for the shareholders. What to expect from us moving forward? Like I said, our main business is to change patient life. Laser-focused on investing on differentiated technologies areas. I think that we are being very diligent and very deliberate on how we invest our capital. That one is like order number one. What we are doing very well that we're not doing before is really capitalizing on our ability to go in an account and start to enter through different areas.
Because just to give you an example, our spine team can access an account from the biologic side, enabling tech, BGT, or spine under orthopedics. The same, we can leverage our orthopedics devices or our BGT device. The ability to have multiple points of access. As I said before, we are being very disciplined on working on our margin expansion, our EBITDA expansion, and on free cash flow generating. All of this to create the basis for a very strong foundation. For people that follow our story, our balance sheet at the beginning of our tenure today changed night and day. A foundation to start to do a lot of fun stuff moving forward as well. This one, I think that is the slide that exemplifies our progress. We moved from, in 2023, to be more than $100 million of free cash flow negative.
We entered Q2 of 2024 with a generation of $21 million. This is just an example of how you can grow in this market in a profitable way. I think that actually I start to see, and this is why investors appreciated our story. This is why more and more people are interested in what we are doing. In Q3, we presented our three-year long-range business plan, which pretty much follows what I just said, a growth of the organization in all of the different businesses faster than market, that on a combined basis is going to be between 6.5%-7.5% net sales figure, an increase of our EBITDA to the mid-teen. We are expecting 300 business basis points of gross margin expansion between now and 2027.
As I said before, at the same time, keep being focused on free cash flow generation. This discipline is a discipline on managing our finance and deliberate on our capital investment on creating technology in areas where we can win, where we believe we can win, is going to be what Orthofix is going to be in the future. At the end, why to invest in us? Why to believe that we can generate value? Strong fundamentals. You saw the success that we had on managing our company. A very focused commercial strategy. I believe that this creating multiple access points into account is creating a lot of value for us, even in areas where we are like the clear number one market player, like in bone growth therapy. At the end, everything happened because of people.
A leadership team that just in less than one year was able to make all of these changes and create all of this value for us. I said discipline on capital allocation at the same time with relentless execution. Of course, everything to make sure that we keep delivering what we said that we deliver. Consistency on this year is just a demonstration to all of the people, all of the investors that want to believe in Orthofix, that we can deliver year in and year out consistent results at different levels from 2025- 2027. I couldn't be more excited about what we're doing. I couldn't be more excited about the technology that we're bringing there and how disciplined we have been. With that, let Caitlin ask us some questions.
Thanks, Massimo. You guys announced results recently. Could you highlight for us what you want investors to really understand coming out of the Q4 results?
Yeah. Look, I think that 2024 has been a fantastic year for us. Imagine that at the same time, we had to keep creating value, keep going deeper in the market, while making a lot of changes in the organization. For many that have been in my seat, you can appreciate how difficult it can be. We didn't lose momentum. We are very excited because all of the changes that we made are bringing us in 2025 with much stronger footing. Our commercial discipline, our financial discipline, our differentiable technology, differentiated technology, all of the different markets is creating a very compelling opportunity for us.
Yeah. Just a couple of the numbers to highlight. We grew our U.S. spine fixation business 14%. Our U.S. orthopedics business grew 16%. We had a record number of 70 placements in the year, 150% growth in that. We improved our EBITDA margins by over 200 basis points. We were free cash flow positive in the second half of the year at $21 million. Just a fantastic year overall, 7% growth for the full year. Very pleased with the performance.
That's great. Massimo, as you alluded to, you guys announced some portfolio management decisions on the earnings call. Maybe let's touch a little bit on the M6-C discontinuation and just the rationale there. Demand had been decreasing. I mean, why was that the case? Anything from a product efficacy standpoint that would cause a decrease in demand or influence your decision to discontinue the product?
Yeah. I said disciplined capital allocation is what we did. We need to make sure to invest in areas that we can win. Besides motion preservation, other areas of orthopedics were not the area where we thought that we could make a difference for our patients. We discontinued, I think, a few product lines in orthopedics. We decided to phase out M6 that after changing life of 100,000 patients, we start to see a decrease of interest. That one, I think, that was what drove the decision for us. Still, the technology is still there available. There is a pocket of surgeons that like the technology. We are going to keep decreasing. They are going to keep letting them access the available inventory until it is going to be phased out.
Yeah. With M6, back to Massimo's point on just the disciplined capital allocation. It was not only a drag on our revenue growth, but also it was negative from a profit standpoint and a use of cash. Again, our focus is making sure that we're investing in areas that we believe we have competitive advantage in with our 7D enabling technology and how that pulls through spine fixation. That's really our focus going forward in the spine business.
You noticed divesting other orthopedic lines as well. Do you have plans for divesting anything else going forward?
No, I think that we feel pretty good about where we are in 2025. Our goal was to arrive at the beginning of this year in thinking about what is the basis finally that we want to create that we can use to build upon and enabling technologies in an area where we can win. We believe that in spinal deformities in an area that we can win in orthopedics, we have all of this great opportunity to redefine lumbar reconstruction. A lot of excitement there. At the same time, we keep investing on our commercial infrastructure and technology for bone growth therapy. We feel very strongly about where we are today.
Great. Maybe let's turn to long-range expectations that you announced on your Q3 call. I think 7% growth at the midpoint now expected for the life of the plan with the M6 divestiture. Do you view this as aspirational or conservative?
This is what we commit to deliver. Consistency has been and discipline has been a word common to our lingo right now in Orthofix. The growth rate on our long-range business plan is something we are confident we can achieve.
You're also expecting expansion to mid-teens, just EBITDA and free cash flow generation as well. Can you talk about the cadence of these improvements over the life of the plan? Do you expect the improvements to be linear or more stepwise?
Yeah. We expect them to be a little bit more stepwise. In particular, we've talked about the gross margin improvement. There are some pretty large projects in there. The benefits will be a little bit back-end loaded. We've talked this year, our guidance was implied EBITDA margin expansion of about 130 basis points in 2025. That kind of sets you up for our future expansion growth being a little bit more stepwise into 2026 and 2027.
That's great. Where do you stand from a balance sheet perspective? How does this help you achieve your long-range goals?
Yeah. I mean, we ended the year in a much better position. We refinanced the company in November. We have a $275 million credit facility in place. Finished the year with $85 million in cash on our balance sheet and $115 million in our credit facility that we have access to should we want to do something with that. Improved our cash position by about $50 million from $35 million at the end of 2023 to $85 million at the end of 2024.
Great. Maybe let's turn to the commercial strategy. I think sharpening your commercial focus has really been one of your key LRP initiatives as you look to leverage your broad portfolio across your multiple call points. Could you give the audience a little bit more color on how you're sharpening your commercial focus across your spine, ortho, and BGT commercial orgs?
Yeah. Let's start to the spine business. In spine, we go through third-party distributor, our commercial partner. One of the focuses since the beginning of my tenure has been, okay, how can we create, how can we start to leverage now the combined portfolio of Orthofix and SeaSpine to create more exclusivity? A great deal of focus on bringing larger distributors that can be exclusive with us, selling the entire portfolio, including Biologic, but also a team that can have a very good use of our asset, our resources. From the strategic point of view, we start to go deeper in the account, leveraging the different technology, but also wider start to find partners that could actually scale with us.
If you see this year, there was a direct conversion on our improvement on inventory management that led also to a very good use of cash. Let's say once we start to see that investing on distributor can scale, it can bring us a lot of opportunity to us. If you see when we move into orthopedics, really redefine more clearly our mission to be a company that can access, can redefine how lumbar reconstruction is thought, is helping us to find also distributors that can sell our mission in a more effective ways in the account. This is why you can start to see an accelerated growth in this specific market because we are redefining the market.
When you go to bone growth therapies, literally leveraging our state-of-the-art infrastructure that we have in Lewisville, our state-of-the-art commercial team that we can control, let's say, much better because we have more than 50% is direct. In every single business segment that we are, we keep evolving our commercial thinking so we can start to leverage all of the technologies that we're investing on much better. Finally, we close the loop, start to really leverage 7D. One of the things that we did different is start to drive a lot of earnouts with our 7D technologies. The fact that we are having more earnouts is creating more stickiness into the account. We're having a lot of success. Just to give you an example, the majority of our earnouts, almost 80% of our earnouts agreement, is way ahead or was the contractual obligation.
This just shows the quality of the implants that we have on one hand and the quality of the enabling technology that we have on the other.
You touched on your progress on gaining larger distributors in spine. I mean, any risk here to losing distributors given the M6-C discontinuation?
No, because what we noticed is that the market segment was very highly differentiated. Surgeons that were accessing M6 were mostly just focused on motion preservation. So not a lot of cross-selling between the two.
Got it. Maybe let's turn to your spine portfolio and strategy there. I guess another strong quarter in US spine fixation, double-digit growth. I mean, do you think this is sustainable? What is driving this high growth in the U.S.?
Yeah. I think that we are bringing the basis of being a sustainable business out there. The technology is there. In the last few years, we launched more than 50 products. We have right now a very fresh portfolio, especially on our interbody. Anterior access and lateral are a very good growth for us. At the same time, the combination between a fresh portfolio with a 7D is creating the stickiness that we want in the implant. Look, at the end, it's just the beginning for us. If you see the evolution on the technology perspective, it's still thinking about all new products that you can use in conjunction with 7D to create an even enhanced experience.
What you're going to see with our focus in the deformity and fixation, a series of launches that are going not just helping us to propel the company forward from the pure revenue perspective, but also to enhance this procedural approach that we want to bring, combining implant with enabling tech with access. The combination of all of these, if you create real value in the art for surgeons, at the end, that one is what really matters. It's going to help us to create much more interaction with our product. At the same time, again, we sell Biologics. We have a great stim business with our bone growth therapy team. If you start to think about us as a company that can start to follow the entire continuum of care of the patient, our patient doesn't leave us when they leave the OR.
It stays with us post-op with bone growth therapy. Being a med tech, a highly differentiated company as we are, is giving us more lever to create the stickiness that we want.
Maybe let's touch a little bit further on deformity. You've talked about leveraging your deformity capabilities to drive share gains. I mean, how are you leveraged to deformity currently? What from kind of an implant innovation perspective are you planning on doing to fill any gaps or just improving on your current offering?
It's going to be few-fold. Right now, let's say we are very, let's say we are competing in the deformity mostly through 7D. 7D is state-of-the-art for open surgery right now in different accounts globally. Actually, one of the interesting statistics for us is that we are so different that we are kind of agnostic of any enabling technology that is already there in the hospital. So you can see 7D, even if there is a robot, if 7D, if there is a competitor, just because in the specific market, we are winning. So that one is like phase number one. Phase number two is going to be still investing on enhancement of the enabling technology platform, but at the same time, investing on a spinal screw system that is going to be fully designed from the ground up as integrated with 7D.
If we can keep delivering differentiable technology associated with a much smoother experience with the surgeons, we can see how we can keep winning in the specific space.
Maybe just a minute or two on 7D. Aside from deformity, any color on how you're innovating there? In terms of the placements, talk about where you're seeing placements. Are these competitive conversions for you, or are you placing 7D into kind of legacy Orthofix accounts?
7D already can be used into brain. Again, it's another value that you bring into the hospital system. You have an enabling technology platform that has multiple use. At the same time, we just got the approval for the EVD, our EVD device, which helps surgeons to drive catheter in brain in case you need to address a post-trauma, a post-trauma accident. It's interesting that it's a very widely large market with a procedure that is considered by many as a, let's say, routine. The reality in the hospital system is that the majority of these procedures are done in acute and most of the time from surgeons that are at the beginning of their career. The actual complication factor is very high. Even if it's not our direct competency, again, it's another way that we go to the administration to show value.
That one, given the small footprint, is just, let's say, the beginning of a new phase of 7D, scaling down the form factor that may help us to access ASC. A lot of excitement there. There are things that we're going to start to introduce on 7D in the next quarter or so that are very highly differentiable, and I'm very excited about the future there. At the present time, I talked before about earnouts, and most of the time it's all new revenue for us. The vast majority of the 7D placements are done in accounts where we are not present yet or accounts that are looking to increase the utilization of our device. Every single dollar of revenue we bring from there is all new for us.
It's great. I think we'll end it there. Thanks, everyone.