All right, cool. All right, good morning, and thank you for joining us at this year's Canaccord Genuity Musculoskeletal Conference. My name is Caitlin Roberts, and I'm one of the Medical Device analysts here at Canaccord Genuity. I'm here with Orthofix, a global medical device company specializing in differentiated orthopedic and spinal solutions. We're very pleased to be joined today by 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'll begin with a fireside chat, and I'll try to leave a few minutes at the end for any questions from the audience. With that, we'll get started. Just let's start off with the Q4 since you guys announced earnings last week. What do you really want investors to understand coming out of the results?
Yeah. Thank you, Caitlin. It's good to be here this morning. Q4 for us capped a quarter of meaningful operational progress for the company, and I think really demonstrated that our strategy is working. We exited the year with strong growth and strong momentum across our businesses, continuing growth with our BGT business, Bone Growth Therapies, and our U.S. Limb Reconstruction business, and improving performance in spine, where we completed our distributor transitions for the year. We also delivered our eighth quarter of EBITDA margin expansion and had a strong positive free cash flow, underscoring our discipline and our choices that we're making, and the scalability of our model. Now I think, you know, as we kind of go into 2026, we have a fully aligned commercial channel, strong financial foundation, and a robust innovation pipeline. We're excited about the groundwork that we laid and where we're going.
That's great. Guidance is calling for 5.5% pro forma growth at the midpoint, 70 basis points of adjusted EBITDA margin expansion, and free cash flow positivity in fiscal year 2026. How are you thinking about the cadence of these goals throughout the year?
We expect normalized normal procedure volume and seasonality throughout the year. Net sales growth in the first half of the year is expected to be approximately 5% and then 6% in the second half of the year. As a reminder, Q1 has one less selling day, Q2 has one additional selling day, Q1 will also have some impact, about 1% for total company related to the CMS pilot program on the BGT business.
Mm-hmm. As it relates to that top line further, how are you thinking about growth within each of the segments?
You know, within each of the segments, we continue to expect Bone Growth Therapies to be a steady performer growing, you know, above market growth. After we kind of get through Q1, we don't expect the CMS pilot program to be a material impact for the year. Our U.S. Limb Reconstruction business, we expect will return to double-digit growth in the second half of the year after we finalize some sunsetting of non-core products that we did towards the end of last year. Spine, you know, we exited 2025 on a good kind of momentum, we expect improved performance throughout the year in Spine. 7D, while it's a smaller part of our portfolio, it is very meaningful to us, especially as it's contributing to our spine fixation growth. We are, you know, intentionally moving our strategy away from capital sales and shifting it more of an earn-out program. We'll have some overall impact to the growth, specifically in that space, but we'll see the growth on the spine fixation business.
What are your biggest levers this year, you would say, to drive outperformance on the top and the bottom lines?
Yeah. I mean, it's all about commercial execution on the top line, on the bottom line, margin improvement. We have some specific targeted programs that we're working on to improve margin. Continuing with our, you know, focus on financial discipline and building operational momentum that we've established over the last couple of years. You know, again, the scalability of our model, we think is really starting to show with the EBITDA margin expansion that we've had over the past couple of years. We this year with our guidance, we'll have since 2023 more than doubled our EBITDA for the over that time period. Also returning to free cash flow positivity for the full year expected in 2026. We were near breakeven in 2025, after exiting a year, two years ago with $100 million in use of cash.
you know, just something else that you announced on your earnings call, just the long-range plan goals being pushed out, one year from 2027 to 2028, but the same goals. What was the rationale for pushing these out? Why did the spine channel upgrades really cause that pushing out? Any risk to the targets getting pushed out or changed further given the channel upgrades?
Yeah. Thank you. You know, the decision to recalibrate the timeline, from 27 to 28 was really to fully capture the benefit of the spine channel optimization that we exited throughout 2025. You know, the recalibration of that timeline doesn't speak to the end markets or our belief in our ability, to, you know, succeed in those end markets, but more around just the timeline of shifting as we really spent time in 2025 upgrading our channel. We felt like it was absolutely the right long-term move to do to upgrade our channel, but it will require us more time to, you know, fully see the benefits, to materialize. Those are now mainly behind us. The commercial channel is fully aligned, and we're seeing healthier momentum as we start this year and as we exited 2025.
We feel, you know, confident in the timeline that we've established. You know, we've got the heavy lifting behind us on the channel optimization. We did sign up some new IDN accounts at the end of the year last year. That we believe the business is set up well for 2026 and beyond.
Maybe just Turning to spine even further, with these upgrades, just maybe speak to the efforts last year. You noted you were done with the upgrades, but then, you know, are these really best practices that you'll continue to utilize going forward?
Yeah. I mean, the significant work that we did, we would say is done and is behind us. Of course, if there's always an opportunity to make changes in certain specific targeted areas, we will take advantage of that. You know, I think one of the things that is encouraging to us, if you look at our business now, over 75% of our business is with our top 30 distributors. If you go back to 2024, that was less than 50%. We've really done a significant job to consolidate, our channel, which is really important. We have an aligned channel. They're focused, they're true partners, and so we really feel good about where we are. Of course, if there's opportunity in specific areas, we'll take advantage of that.
Then what would you say your selling points are to the distributors and the surgeons as a smaller company in the space? Is there anything, you know, such as gaps in your portfolio that would make a surgeon or distributor hold back from becoming a customer at this point?
Yeah. I mean, I think our selling points are focus. We do have differentiated technology and, you know, we're able to partner in a very nimble way. Our innovation pipeline now is stronger than it's been in recent years. We're making meaningful and continued enhancements to 7D, which helps them with their business and is a growth catalyst for our partners. We don't, you know, at this point, see any significant gaps in our portfolio. We feel like we have a broad base that you can really represent all of the therapies that your physician would need.
Also the landscape is really continuing to evolve competitively as certain strategics really shed their spine businesses, others maintain a steady focus. How have you been able to really capitalize on that disruption in the marketplace?
I mean, we've been able to take advantage of that in 2025 with, you know, bringing new distributors on. We think that, you know, anytime there's disruption, it can create opportunity. As we see that opportunity, if it makes sense for us, with our goals, we'll take advantage of that opportunity.
Maybe we'll touch on 7D further. Where did you end 2025 with 7D from an adoption perspective?
Yeah. We don't specifically talk about placements, but our earn-out placements were 30% up above 2024. Strong activity in the year. You know, another thing with those placements is that we saw that our placement accounts collectively were over 50% of their volume commitment. Really strong usage with those earn-outs that we're placing that we're really seeing high attachment to our other products and the ability for it to pull through.
Mm-hmm.
Very encouraging results.
You know, 7D really has this imageless workflow and quick registration, which are positive selling points. I mean, how much have those, you know, the radiation reduction really been selling points to doctors? Is it something they're increasingly concerned about?
Yeah, I think, you know, it has become more of a discussion, a more frequent discussion, and is increasingly getting awareness. Over the past few years, that trend is only continuing. What we consistently hear is that, you know, clinicians are concerned about their exposure, but not only their exposure, the OR staff exposure, as well as their patients. As this, you know, kind of is continuing, it perfectly kind of aligns with what 7D can provide, you know, in an OR from a, you know, radiation-free or 98%, radiation-free environment in the OR.
Mm-hmm. Then just reception in different sites of care, what's your mix currently between inpatient versus outpatient ASC, placements of 7D?
Again, we don't specifically talk about that. You know, 7D is very well positioned to succeed in either care setting. Its footprint is, you know, small, and so it can succeed either in a hospital setting or in the ASC setting, and we have, you know, examples where it's doing well in both of those care settings.
Mm-hmm. Then can you speak to the pipeline, any new features you plan to add to the system in the coming years?
Yeah. You know, what I would say is that those features, while we're not gonna talk about them specifically, that they're focused on the themes, that make 7D so attractive, which is workflow efficiency, clinical precision, and reduced radiation exposure. Those are the areas where we're really focusing as we think about what's next for 7D and bringing new technology to that.
Maybe just rounding out this channel and talking about biologics. On the earnings call, I think you noted a renewed focus,
Mm-hmm
On biologics. How have the spine distribution upgrades really impacted this business, and what have you done internally to refocus?
You know, over the past year or so, we have seen some softness in biologics, particularly as we've worked through this channel optimization on spine. We've really taken steps to re-energize this business. We've made some internal changes in terms of optimizing our sales channel and our leadership. We're, you know, strengthening kind of our oversight of that business and investing more in clinical data for that business. We're excited about what we're seeing, you know, as we start to Q4 or Q1, excuse me.
Just maybe to understand the channel a bit better, does a distributor necessarily have to carry your biologics with your spinal implants, or can these be separate lines of business? Do most end up utilizing both?
Yeah. Generally speaking, you know, a spine distributor will also carry our biologics bag as well, but we're not limited to that, so we can go beyond. Where it makes sense, you know, in addition, we're seeing opportunity with our limb reconstruction business, that it's not just a spine platform, but can also be used with limb reconstruction. You know, we see opportunity beyond just our spine channel, which it makes it, you know, a great durable business for us.
Yeah. Maybe just turning to limb recon. You renamed the segment this quarter from orthopedics. Just give us maybe the rationale for the switch.
We renamed our orthopedics business to Limb Reconstruction. We believe it more accurately reflects kind of our strategic priority and our strategic focus. You know, the old name, orthopedics was also often conflated with hips and knees and which wasn't our business and what we did. The new name for us highlights kind of our differentiation, our differentiated portfolio and the surgeons that we're really supporting. It really focuses on four high-value clinical areas: limb preservation, limb lengthening, complex fracture management, and extremity and deformity correction, and better reflects what we do and what we provide in the marketplace.
We've talked a lot about the spine distribution upgrades you've made, but maybe talk to the U.S. ortho go-to-market strategy here and how greenfield is it for you guys?
Yeah. It's still very much a greenfield, the U.S. is still very much a greenfield opportunity for us. The limb reconstruction business is primarily the majority of the business is international right now outside the U.S., and about 70%, about 30% in the U.S. We see a significant opportunity. There's a $2.6 billion TAM in the markets that we play in, and we see a significant opportunity to focus there. There's not other companies that are focused on it, we believe, in the same way that we are right now. We're excited. You know, we're continuing to see enthusiasm from our distributors that are looking to partner with a company that's bringing these unique capabilities to the market.
What products do you have left to fully launch, or even just launch initially in the U.S., in this segment? Anything new to the product portfolio coming down the pipeline that you wanna highlight?
Yeah. We are, you know, still focused on launching our TRULOCK Elevate product line and our Fitbone, bone transport as well in trochanteric nails. Those were launches last year. They are market development opportunities, so there is a, you know, a long ramp to get where we wanna get and make those meaningful. We're also looking at, you know, helping bring additional technology that automate those procedures. Really investing. We believe that that's an area that's really untapped today in the marketplace and we're focusing on.
You noted the business is pretty leveraged to international at this point. What's really the strategy over time, and do you expect to become more leveraged to the U.S. versus international?
Yeah. Our, you know, our international limb recon business is definitely more penetrated than the U.S. It's a very important part of our business. It's where the business started back in 1980, was really around this business, in Verona, Italy. We will continue. It'll continue to be a meaningful part of our portfolio. We believe that in the U.S., really to make the business what it needs to be, we also need to have a focus on the U.S., that's really the transition you've seen from us over the past, I would say, you know, 18 months or so as we brought on new leadership and we really refocused and really defined ourselves as a limb recon company.
You've had pretty high growth in the U.S. recently. I mean, how long do you expect to really sustain that high growth trajectory?
Yeah. I mean, we see, you know, that being sustained in that, you know, our U.S. limb recon business will grow faster than the overall company, growth rate over a number of years. Again, it's a really large TAM. We've got really compelling technology that we're bringing into that space, and we're just really at the beginning of that journey.
Mm-hmm. Maybe let's quickly touch on M&A. How are you viewing the opportunities in the space? Where would you like to bolster your portfolio inorganically?
Yeah. I mean, we always keep, you know, our eye on external opportunities. Right now we're focused on running the business and generating positive free cash flow. If something makes sense, you know, I'd say more of a tuck-in type of thing, we would definitely be looking at that. We're kind of now at the phase with, you know, what we've done financially with strengthening our balance sheet over the past two years that we're able to consider those things and take them on.
Mm-hmm. Awesome. Then just maybe wrapping up, anything you wanna leave investors with, about the business and about the quarter to highlight as we finish up?
Yeah. Thank you. Yeah, I mean, Orthofix today is, I think, fundamentally a stronger company than it was a couple of years ago. We're commercially aligned, innovative, innovation driven, and we have a much greater financial discipline than we've had at any point in our recent past. Our financial foundation is strong. We're very excited as we're looking forward. I think from my perspective, the opportunity that we have ahead is very meaningful and makes Orthofix a compelling story and a place where we can create long-term shareholder value.
Wonderful. A few minutes left if anybody has any questions in the audience. All right, we can wrap up early then. Thank you.
A shout-out for the lunch panel. Our Chief Enabling Technologies Officer, Beau Standish, will be participating. If you're interested in learning more about 7D and a few things that Julie talked about in terms of that, lunchtime panel today.
Thank you, Julie. Great shout-out. Thank you, everyone. Thank you.