All right. Good morning, everyone. Welcome to the 2026 TD Cowen Healthcare Conference. My name is Matt Blackman, and I am the newest member of the MedTech research team. Along with Joshua Jennings, my partner, we now have a two-headed MedTech research monster. I'm pleased to kick off our conference with SI-BONE. We're really very grateful to have with us from the company Anshul Maheshwari, CFO and recently appointed COO. Congratulations, by the way. Most importantly, thank you so much for joining us. Really appreciate your time.
No, we appreciate you guys having us. Thank you.
I'm gonna start with some bigger picture questions. We'll talk through maybe some recent announcements, including Anshul being named COO and talk to what his new responsibilities are and if he has any marching orders. I thought maybe we'd start big picture because the company's evolved quite a bit over the last five years. We've seen it evolve from what was once a single product company to now a portfolio of products, treating a variety of disease states. The language you're now using to describe the strategy is something akin to position to solve unmet needs for patients with compromised bone.
Mm-hmm.
Maybe help us understand what that means, what the mission is from here, how you're thinking about the company and the portfolio. I guess what I'm really getting at is where can you go from here, within the SI anatomy or broader?
Thank you again for having us. You're right. When we started the company, we were the SI joint dysfunction company. We were solving an unmet need of SI joint dysfunction, and we started with the Triangle, and since then we've evolved into additional technologies that solve the disease state of SI joint dysfunction. As you know, the sacrum has one of the most poorest quality bone in the human body, and our technology's ability to drive fixation and fusion provided us a very strong platform from which we've built into multiple other technologies addressing additional disease states all within the SI joint.
What we've been able to do is we've been able to use our biomechanical expertise, our expertise in designing and manufacturing, and additive manufacturing, which is 3D-printed solutions, and have been able to expand that into the deformity side with Granite, and then most recently on the trauma side with our recently launched TNT product. It's now been out for about 15 months. We actually have a pretty good track record of working with patients and solving unmet needs, where you have compromised bone. When you think about compromised bone as a guiding principle, our focus has been targeting markets where there is an unmet need or where the current standard of care is subpar that leads to high revision rates and high failure rates. We've done that in three markets already.
Now what we wanna do is we wanna take that skill set, work with our core call points, which is spine and interventional and now in trauma, to be able to come up with solutions that are clinical adjacencies that can leverage this biomechanical engineering to come up with new solutions, go after new TAMs. What you've seen is an evolution of a company from one solution anatomy and different disease states to now focusing on multiple disease states that are in adjacent clinical cases with the same call point.
Many of these ideas are sort of inbound from some of your physicians who say, I've used your technology here. You know, it'd be really great if we could do something here.
If you think about the evolution of our portfolio, we had the Triangle, and we had a 3D-printed Triangle in 2017, sorry. What we saw was our physicians were using the Triangle as what we call a Bedrock technique when they were doing deformity procedures. If you simplistically think about what leads to failure rates in a lot of deformity procedures over time is rod fracture, screw breakage, or screw loosening. The simplest analogy is if you put a flagpole in quicksand over time, the flagpole will tilt. What Bedrock Granite as a technique, which was using our Triangles at the base in the sacrum did, was it provided you a solid foundation for these deformity procedures.
The feedback we got was, I see the benefit of the Bedrock technique, but I would love to have a solution that fits within my workflow, that attaches to my long construct, fits my workflow. That was the evolution of Granite. Basically, Granite was a 3D-printed sleeve with a shank and a tulip head that attached a long construct, provided fixation and fusion, which is why it got Breakthrough Device when we launched it. Trauma is very similar. We started with TORQ in trauma, physicians loved TORQ, and their feedback was, look, I'm very used to getting a screw that goes from one side of the sacrum to the other side of the sacrum.
Would love to have a technology that incorporates the form factors of TORQ, but provides me something that is akin to my workflow. That was TNT. Not all 3D implants are the same. The biomechanics that you need to understand when you're trying to fuse two sides of a joint is very complex. TORQ launched in 2021. TNT came out in 2024, Q4 of 2024. That's how long it took us to develop. Similar to that, as we think about disease states where our physicians know of high failure rates, we're focused on those. It is inbound, but it is also us looking at these markets where we can drive deeper physician engagement, grow our physician base and more products per procedure.
Let's transition about interesting amount to call the partnership with Smith+Nephew. To back talk about the relationship in general, what it Smith+Nephew, the reach and resources that they bring to the table that you are unable to replicate today?
TNT, which launched in the fourth quarter of 2024, has been a really good product for us. It's exceeded our own internal expectations. What it is targeting is sacral insufficiency fractures. Before TNT came out, there was no real good treatment for patients who had pelvic ring fractures. You either had bed rest, or you were using cement, or you were using traditional screws, which as we know from our history in SI joint dysfunction, tend to back out. TNT solves for that problem, which is why it was given Breakthrough Device Designation. Again, that was our second Breakthrough Device. We've seen really strong adoption of TNT in trauma, simply because trauma is not where you see a lot of innovation as well. This was one of the most innovative products in trauma. It is a separate call point for us.
A lot of these procedures happen in Level I, Level II trauma sites. Our approach always with TNT was that to truly unleash the potential for this product, we wanted to leverage a hybrid sales force. It is not a new concept for us. We've done that with our Granite product line. When we launched Granite, we used the hybrid network to be able to really unleash the potential for that product, and it's worked out really well for us in that franchise. Our focus always with TNT was how do you replicate that? Because we don't think the best use of our reps time is to be sitting in Level I, Level II trauma centers.
We want our reps, which is our biggest asset, to be out in the field, to be training surgeons, spine and interventionalists, and to be getting other procedures and go deeper with that call Smith+Nephew checks the box for us. It really allows us to scale the opportunity with TNT and TORQ in trauma. It gets us in front of a large segment of trauma surgeons at Level I and Level II trauma sites and allows those surgeons to get access to a product in the most effective way. Effect also, what it does for us is takes our reps out of that trauma call point. It allows them to focus on the larger TAMs that we have. Trauma is about a $300 million TAM for us. Overall, our TAM's $3.5 billion.
You think about the $3 billion TAM is where we want our reps to be focused on, and that's with interventional and spine. It's worked out really well for us. We signed the agreement two weeks ago. We're in the phase of figuring out how we do the launch. We're gonna put out surgical capacity in Q2 and Q3, and then we're off to the races. We're really excited about what this can do to the trauma business as we go through the year in 2026, but more importantly, as you set yourself up for 2027 and 2028.
I don't think you've included it in your 2026 guide, right? Not to a significant magnitude.
Yeah. For us, trauma was always a distribution model, and we were gonna be either doing a Smith+Nephew, or you were gonna bring on multiple agents, which would have been a much more time-consuming process and would have taken us longer. What this does is, in a very efficient way, gets us access to a large group of trauma surgeons at several Level I and Level II trauma sites. It actually accelerates our ability to get more than what we would have gotten ourselves just building it out.
In the scale of that footprint Smith+Nephew has in trauma or any sort of metric that helps us understand the level of presence, the magnitude of presence they have in.
Yeah. I would think if you think about the orthopedic franchise, you know, you've got DePuy Synthes, you got Stryker, and you Smith+Nephew. that's sort of the playing field for us. We've been very Smith+Nephew in identifying sites where they have the presence and the support, and we know that we can get access to the talks.
Have you talked about the economics? I don't think so.
We don't disclose the economics. For us, the way to think about it is it accelerates the opportunity within trauma, which is accretive to top-line growth. It frees up our reps from focusing on trauma and being able to focus on degen deformity, SI joint dysfunction, plus the new technologies that we wanna launch with spine and interventional. That also becomes accretive to top-line growth. For us, the focus is how do we make sure we're delivering strong top-line growth similar to what we've delivered since our IPO.
Mm-hmm.
This allows us to be able to do that.
Yes, in two different manners.
In two different methods.
Gotcha. I think you mentioned this, Q2, Q3, build surgical capacity, training Smith+Nephew reps, it's sort of off to the races.
Exactly.
Okay. Maybe next, another sort of taking a step back. You know, I know we cover the orthopedic space, you know, hips and knees, spine in particular. The other broad orthopedic markets have stepped up in growth a little bit. I want to, you know, calm my horses a little bit here. Talking about 2%-3% is now maybe 3%-4%. That's a big number in percentage terms. Maybe just if you could just frame the different end markets you're involved in, what you're seeing just in terms of underlying trends, whether it's SI joint dysfunction, pelvic fixation, trauma, just the sort of the state of the union on those markets, as you think about 2026 and beyond.
Are you seeing the same Again, you're in market penetration, market share mode, but just your sense of what the underlying procedure environment is?
Right. When you think about SI-BONE, and you go back to our IPO, we've effectively grown anywhere between, you know, 4x to 6x the underlying, let's call it spine ortho growth, industry growth. Our CAGR growth's been about 20% since our IPO, we're really proud of that. What differentiates us is we're not a me-too product company. We identify these unmet needs, we develop those markets, and then we basically build a platform technology that becomes an industry leader in that market. We feel very good about our position and continuing to perform better than the overall market and multiples better than the overall market.
When you think about the breakdown of the different markets, I'm not gonna give you specifics on where our growth breakdowns are from a percent perspective, but what I would tell you is if you look at 2025, we had double-digit procedure volume growth across all our markets. If you look at from a call point perspective, we had record number of interventionalists do our procedure. We had a record number of trauma docs do our procedure. We had a record number of surgeons do our procedure exiting the Q4. Again, really seeing good traction there, and those were all double-digit percent growths. Overall, we continue to be very well positioned there.
Even when you think about a market like deformity, which is sort of a 5%, 6% grower, by coming out with unique technology like Granite, we've been able to grow our market in deformity multiples of what the underlying market growth is. What you're gonna see from us going forward, as we continue to focus on identifying these procedures where you've got high failure rates or no real good standard of care today, is we wanna be able to come out with technologies like we have in the past and deliver that above market growth rate, right? We have a proven track record of that, and we feel very confident that with the investments that we're making in R&D, with the investments that we're making in direct and hybrid commercial infrastructure, that we should be able to do that.
Okay. That's actually a good segue. As we sort of think about your 2026 guide, I'm sure you've gotten it. I've gotten the feedback as well that, you know, your guide implies a deceleration from that sort of typical type top-line trajectory. I guess some folks are confused, maybe, concerned might be a strong word, but just in the context of juxtaposing 2025, where you had another robust year of growth, but no real new product launches, and now 2026. At least one. We know a second one is coming. Smith+Nephew partnership. You know, I appreciate it's early days. There may be some conservatism, but is there anything we should be sensitive to in terms of the guide and the modest step down versus what's implied versus 2025?
Yeah. When you think about our guide philosophy, we always wanna be thoughtful about the tailwinds that we have in the business. When you think about coming into 2026 and tailwinds we have in the business, you're spot on. You've got tailwinds. These are the most amount of tailwinds we've had in the company's history in any given year. You've got reimbursement tailwinds, starting with a 17% increase in office-based lab, reimbursement, which is where our allograft product with interventionalists does really well. We believe it's become the preferred solution for interventionalists in that side of service. You've got the NTAP for TNT. That went effective October 1, 2025, so you've got a three-year tailwind on that as well. That's around $4,100, which is quite meaningful, between 20% and 30% increase in Medicare reimbursement.
You've got the potential for Granite being used in an outpatient setting with the new Level 7 APC code being established for spine procedures. Granite has a TPT, which basically has a zero device offset. For Medicare cases, you get fully reimbursed for Granite when used in an outpatient setting. You've got great reimbursement tailwinds there. You've got a commercial footprint that continues to grow both organic, the direct commercial footprint, where we wanna add more territories, you've also got this hybrid model that continues to grow for us as well on the interventional side, on the trauma side and the deformity side. We're feeling good about the commercial framework. You've got the benefit of new product launches.
You've got the product launch of INTRA Ti, which you just launched a week before earnings, so two weeks ago, that effectively uses the best of what we have from our allograft solution, iFuse INTRA X, which is a posterior approach, a percutaneous posterior approach to put the implant into the anatomy. It is a single-use kit, it's a very workflow efficient model. The reason it's important is it aligns with the same trajectory that interventional docs are very comfortable with. We think that's a nice huge opportunity for us to continue driving growth in the interventional market for SI joint dysfunction. You've got this third Breakthrough Device that we expect to file 510(k) for in the third quarter, and looking to commercialize it as early as late 2026, but definitely in 2027.
A lot of tailwinds in the business. What we wanna be thoughtful about is it's still early days. We wanna grow into those tailwinds. The most important thing about those tailwinds is as you go through the years and those tailwinds materialize, those are secular tailwinds that will continue to 2027 and 2028. It actually sets the business up really well over the longer term, not just for this year, but for the next few years. Then when you overlay on top of that the innovation pipeline that we have for new products to be commercialized in 2027, 2028, we're set up really, really well.
Yeah. I'm gonna get to the innovation super cycle in a moment. I wanted to finish though in this sort of big picture section that we were looking at the new COO. I'm just curious what your new responsibilities are, and if you have any specific marching orders?
Well, one, I just appreciate Laura and the management team and the board supporting me in that new role. Really grateful for that. I don't think anything's changed for us. Our focus remains growth. You know, I have a function within our project management office that's now reporting under me, but that function is purely focused on how do we make sure we're getting products out at a regular cadence every year going forward. That's number one.
The second piece is field efficiency, so we have IT. Our focus over the last 18 months has been how do we make sure that we're reducing the admin responsibilities on our field? How do we go automate? How do we get more predictability on the workflow and things that they're doing? How do we get better traction on asset utilization? 'Cause that impacts gross margins quite a bit. The third piece is operations, which is again, focused on gross margin expansion. How do we bring our supply chain efficiencies into play, so we can continue to maintain industry-leading gross margins? We right now are 78%, 79%.
Productivity, working capital-
Innovation.
Manufacturing innovation. Okay. Well, good luck. Maybe we'll talk we sort of teased some of them, but we'll talk about some of the key products that are gonna drive the top line, not only this year, but over the next several years. You did mention INTRA Ti, just maybe in very recent early days. I appreciate that. How do we think about the adoption curve in 2026 and in 2027? Is this sort of a slow burn, sort of build then hit critical mass, or is there some sort of inflection point that you hit where it's sort of off and to the races? Just help us understand how it builds and to the top line over the next couple of years.
If you actually take a step back, we started working with interventionalists in 2023. When we did that, we started with TORQ. TORQ had been in the market for quite a bit time. We actually did the STACI study. We launched the STACI study, which was looking at interventionalists using TORQ to do SI joint dysfunction. We provided preliminary data on safety and effectiveness, and it was really good, and you published on that. In 2024, we launched our allograft solution, which was INTRA X, which was the posterior percutaneous solution for interventionalists that may have not wanted to use metal as the first line of defense or did not wanna use the lateral approach initially. The allograft product was an office-based lab product. It's done really well for us.
What we want to make sure is that we have a robust solution set for interventionalists to be able to perform SI joint dysfunction procedures. INTRA Ti is an evolution of that. When you think about application of INTRA Ti, I would put it in a few buckets. The first bucket is in markets where 27278, which is our allograft solution, is not reimbursed. INTRA Ti, because it has the same workflow, it's a single-use kit, it's very efficient, can be used. That's application number one. We know physicians liked the INTRA X workflow. INTRA Ti solved for that. We knew physicians like the simplicity of a single-use kit. INTRA Ti supports that as well, it's got nationwide reimbursement under 27279. That's number one.
Number two is, there are docs that don't wanna use allograft, that do wanna use, that do wanna use metal. INTRA Ti, because of its approach, provides interventionalists a convenient way and an efficient way of incorporating metal in their workflow practice when doing SIJ dysfunction procedures. Number three is for physicians that are using TORQ, it provides them with just another alternative based on patient demographics on being able to provide them another solution.
I've always been interested, you know, there's sometimes friction between the spine channel and the interventional pain channel. Just how you manage that. Is that a consideration? Do you have to be sensitive to that when you think about your customer base and going after different customers?
Yes. Surgeons still account for the vast majority of our business, whether it's SI joint dysfunction or degenerative deformity. When we went into the interventional spine world, we were very deliberate in our approach. The approach we took was, we know that there is a subset of patients that are in interventional pain that are being managed conservatively, and they're not being referred to surgeons. We were very targeted in our approach to go after interventional docs that today were not doing referrals to surgeons. This was an incremental funnel for us that we weren't gonna access any which way through the surgeon network.
I think we've done a really good job in managing both sides by making sure there is no cannibalization, by making sure this is incremental, and by making sure that the conflict, the inherent conflict that you talked about, doesn't really exist. The reality is interventional pain docs that have a symbiotic relationship with surgeons, the referral relationship, don't wanna disrupt that to start with anyways. I think our approach has worked. I think it's been respected both by the spine side and the interventional side, and you can see that in our physician metrics, which have all hit record numbers in Q4.
Okay. I'm gonna skip ahead in my question list because I do wanna hear you talk about, well, tease us again, on the new product that's on track. I think you said 510(k) submission 3Q, maybe launch late 2026, maybe 2027. Just as best you can, give us some flavor for what that is, and maybe another way to frame it, whether it's sort of TAM expanding into a new adjacency, or is it something that drives incremental penetration in existing disease state functions? Just anything to help sort of, help us dream the dream about what this could be.
Well, look, it's. This is our third Breakthrough Device. We're one of the few companies that can claim that they have three Breakthrough Devices in med device. We're really proud of what the team's been able to do. You're right, we're gonna be filing for 510(k) in the third quarter and hope to commercialize this by late 2026. This product is addressing one of the most known unmet needs in spine. Let's start with that. Physicians know about it. There's no good solution out there. They've seen what our technology can do, and this is what allowed us to focus on developing this new solution platform. Let's start with that.
Number two is, I'm not going to say a lot more about what the applications are, but I will tell you the characteristics of this product that make us really excited. The reason Granite's done so well was it was an unmet need, it was a known disease issue, it was a known failure rate. Let's start with that. It was training light because it fit physicians' workflow, and it had favorable reimbursement. This product has a lot of those characteristics. It's a known issue. It's an unmet need. It fits the physician workflow. The fact that it has Breakthrough Device designation. We will apply for NTAP, assuming we are successful. That NTAP will be additional reimbursement for the solution as well.
The other thing it does is it's within the same call point that today uses Granite and that today uses iFuse-TORQ in SI joint dysfunction. It allows us to work with that same call point, get more docs to adopt our procedure, get more products per procedure, and get more procedures per doc. It actually sets us up really well for the second metric that we're really focused on, which is driving physician density over time.
Yeah. Okay, that's helpful. Maybe I teased it a little bit earlier, but the pipeline in general, the innovation super cycle, what does that mean exactly? I think relative obviously to what you've seen over the last several years, you've been a very innovative company, but it makes it sound like there's even more.
Right
Innovation coming. I guess maybe if you could frame it, again, in sort of a similar vein. Is it a TAM expanding? Is it increased revenue per procedure? You know, dollar share per procedure. Is it still capital light, still the focus? Just any sort of flavor on that.
Yep.
Is this a two to three-year phenomenon or a three to five-year phenomenon? Any sort of time horizon would be helpful.
Sure. When you think about our business, because we're developing differentiated technologies, it'll take us a couple of years to develop a platform, right? When we start talking about this product that we wanna commercialize at the end of this year, which is a whole new TAM for us, the Breakthrough Device, we started working on it a couple years ago. We started talking a little bit about it with investors to sort of show them a little bit under the hood on what the company is doing. If you think about the business over the next five years, you're gonna see us launch products at a very regular cadence every year. We have already identified several areas where you have high failure rates, especially when you think about compromised bone.
Whatever failure rates or revision rates you see in traditional procedure types, you can multiply that in compromised bone patients as well. There are multiple TAMs out there that we're targeting, that we're developing technologies for, that are gonna be targeted to spine and interventional. Again, the same call points allows us to get in front of them sooner with technologies that they know will help them improve patient outcomes. Those products are already in the works, right? You'll see us on a regular cadence launch new products. The best way to think about it is, if you look at what we did between 2021 and 2024, we launched three new products, which was iFuse-TORQ, Granite, and another version of Granite. You saw what it did to the growth rate of the business.
You're entering a very similar period. Those were all TAM expanding, right? You're entering a very similar period of new products that are going after these unmet needs, and those are TAM expanding. We feel really good about that. On your question around change in business model, there's gonna be no change. We're gonna be focused on differentiated technologies that have high gross margins that stay true to our asset-light model and allow us to get the commercial leverage by going after the same call point.
Great. I'm gonna squeeze one question in the last three seconds. You did give us sort of directional guidance for EBITDA in 2026. I think you said positive. I think the street has landed sort of $10 million-$12 million. Is that the right ballpark? Are we hearing you correctly? I appreciate you wanna give yourself some flexibility, but just, you know, are we thinking about positive correctly as the sell side?
Yeah. I'll give you a bit more longer term answer for adjusted EBITDA or even free cash flow. Our focus is top line growth. The reason our focus is top line growth is if you look at what happened in the last three years, you know, we had a 50% or 40% drop-through of whatever dollar we had in the top line to the bottom line. Now, we are going to make investments in the business this year, which is expanding our sales force, preparing for the new product launches, but we're not putting all the potential impact of that on the top line into our expectations right now. You've got upside there.
More importantly, if you think about the business over the medium to long term, we've said externally that our leverage, which is our revenue growth versus OpEx growth, will range between 1.2x and 1.7x . I expect that to play out. What that does is if you extrapolate, let's say, the midpoint at 1.5x leverage for the next three to five years, you get a pretty healthy adjusted EBITDA, and you get a pretty healthy free cash flow. Again, that is coming from not OpEx expense management. That is coming from accelerating that top line growth, which is where our focus remains.
Okay. All right. We'll leave it there. It was really great to have you. Really appreciate your time. Thank you everyone for joining us.
Thanks so much.