Xtant Medical Holdings, Inc. (XTNT)
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14th Annual Jefferies London Healthcare Conference 2023

Nov 16, 2023

Operator

I have Sean Browne, the CEO, who will be walking us through some slides. Over to you, Sean.

Sean Browne
President & CEO, Xtant Medical

Great. Thank you. Welcome, everybody. As you'll see, we're, of course, gonna be making some, you know, forward-looking statements, so I'll make that, and you can read that, certainly on our website as well. But yeah, so who are we? Xtant Medical is a leading orthobiologics and spine motion preservation company. So, our mission starts with really the basis of our business. Our business is, a business that was based around, a tissue banking, the fact that we take human-derived or create human-derived orthobiologics. So our mission is to honor the gift of donation so that our patients can live as full and complete a life as possible. So part of that is basically not only what we're doing with respect to creating our orthobiologics, but also what we do with our motion preservation business.

So first of all, we're a company that's based in Bozeman, Montana, of all places. So, we are a technology that was transferred out of the Montana State University. There was a merger that took place between Bacterin and biologics and X-spine Systems in 2015. Unfortunately, that merger wasn't necessarily a merger made in heaven. So our story today is about how we picked it back up and rebuilt the company. So, our revenue back in 2022 was about $58 million. This year, we'll be growing by over 70%, with 18% organic growth on top of that. So we'll talk about our growth. But really, the big message I wanna leave with you today is this platform for growth that we've created.

We've got exceptional market access, especially for a subscale company, a scalable business, and that's something we're starting to see right now as we get moving in 2023 and into 2024. And happy to say we're a cash flow business. So when you think about our business, you know, this is a slide that no less than a couple of weeks ago, I would belabor all the things that went wrong with this, with the execution of the merger that I was never there for. But what I can tell you is that since we, our team has gotten in 2019, we're gonna really grow the business in really meaningful ways.

But most importantly, we really had to break down the business in its most core functions, really re-engineer literally every process, break down the cost basis by how we did things, and then through that, we raised money, converted our debt, raised some more money, was able to then, in this past year, we've been able to acquire really three businesses that have helped us really scale and become quite a significant player, especially in the orthobiologics world that we play in mostly. So our management team, great team of guys that I've been blessed with and a great team behind all of these people as well. I'll say that one of the great things about working out of Bozeman, Montana, even though I don't live there personally, is the people there are.

Not only are we getting so many of these very, very, very bright people that are coming from all over the country who want to live in the mountains, but we also just have a very hardworking, outstanding group of people that, that really believe in our mission. So when I think about where we've been, you know, we think about it from 2020 to where we are today, you know, it's been a long way, right? We're gonna be, as you would look at it from an annualization, you know, we're probably gonna be in the 110% to 120% if you annualize. 110-120 annualized in way of our revenue. So we're basically doubled in size over the course of the last year.

This has been something, at least from our side, we've been really very excited about because getting to scale has been one of our main goals. When you look at our product offering, so our product offering comes in really two ways. One, there is the spine, what I'll call the traditional hardware. But on top of that traditional hardware, we are going down a path of what I call motion preservation. And motion preservation is if you think about any time and anything within the orthopedic world, only in spine, where fusion, the fusion of a joint, is actually the first thing that doctors turn to, and so where surgeons turn to. You know, you think about anywhere else, could you imagine fusing your shoulder or fusing your hip or fusing your knee or an elbow?

It's just bizarre. And I'm not from the spine world, so this is particularly interesting to me. But yet in our spine, we'll fuse a joint. We'll actually fuse a level, and we'll fuse multiple levels. And if you can imagine this, is that let's say they decided one day they're gonna fuse your knee, you would then immediately have problems in your hip and then your ankle. And that's exactly what happens with a joint when you look at adjacent segment disease. And so that's something we're really trying to work against. The other part, and two-thirds of our portfolio, is what we do in the orthobiologics space. In the orthobiologics space, we have, like I said, a leading position in a number of the categories.

The big thing that I really want to emphasize more than anything else is the platform we've now built, and it's a platform that, quite frankly, when you think about it from companies, as we go down the path of acquiring more businesses, this is one that as we look at acquiring subscale businesses or businesses that are cash-constrained, the idea that we have access to all these areas. One, we've got almost over 90% of the hospital beds covered in the United States. We've got a very large and growing independent agent distributor base that covers the full nation. We've got an expanding biologics capabilities, so I'll talk about that and what that means for us from a margin perspective. We now have, believe it or not, this is something every other part of healthcare focuses on: managed care.

Well, in the world of spine, it's not. There's only literally one other company that I think has another managed care payer services capabilities, and that's SI-BONE, because they too, like us, have a PMA-based product that has its own, its own CPT code. So we also have, we're one of the few people that as everyone else is running out in the med tech world, out of Europe, we're running in. Part of what we acquired in our Surgalign acquisition was the international distribution network. There's a number of great opportunities for us of companies that are medium and small size that left, that are, we now have the opportunity to start filling in and, and start taking some share. And then last but not least, as I mentioned, this less invasion, less invasive motion preservation system is something we're very, very serious about.

You know, if you're gonna be competing against these billion-dollar companies, you better have something different and/or unique. Our, you know, motion preservation systems of the Coflex system, Coflex/coFix, along with our DCI product that's comes from the Surgalign acquisition, which is a disc implant, and then also our HPS system, a coupler system that can actually be tied into a full fusion construct, but yet still allows for full motion preservation. So the market that we deal with is a sizable market. It's a $10 billion market internationally, $8 billion domestically. The area that we have focused a fair amount of our energy and time on, and where we also can be different, is in the orthobiologics space, which is about a $2.4 billion opportunity in the U.S.

Today, there are five major segments within that world. Prior to me and our team coming on board, we really only served in the first two, which was demineralized bone and allograft. Now we are in all five segments, and so that was one of the things as we started raising money, we started putting dollars into adding these categories such as synthetics, such as viable bone matrix or stem cells, and then, of course, on the growth factor side. So when I think about the next big move for our company overall, it's gonna be our ability to start manufacturing higher-end biologics, 'cause that's what we manufacture. All of our hardware is actually manufactured by subcontracted groups.

And so when we think about what comes out of at least these new in the next six to nine months, we'll now be producing products that are significantly more at least higher profitability, significantly higher on the technology side of things with respect to what the business looks like. And quite frankly, three of these product lines are product lines we're sourcing today. So we source them today, the margins by which we get them are somewhere in the, you know, low to mid-50s. By making these products, we'll now be in the low to mid-90s, and so a significant opportunity to increase our profitability. So when we think about growing, our growing comes in four pillars. Pillar number one is new product flow. Pillar number two is expanding access and our distribution network.

Pillar number three is leveraging adjacent markets, and really this gets into our OEM discussion, our OEM opportunities. And then last but not least, of course, is the M&A piece. So pillar number one, what are we looking at? From an orthobiologics perspective, you know, we're focused, as I mentioned, on developing upgraded versions. You know, it's so funny, the gentleman who just got done before, when you look at...

and many of these presentations over the last few days, you look at the very, very, very high science and the very, very, you know, level of, and this is actually something I'm accustomed to because I'm not from spine, is the level of proof that one must get to in order to be able to show and actually get to whether or not a drug is significantly different than others, right? In the world of orthobiologics, it's unbelievable how low that bar is. And so one of the things that we plan on doing is really raising that bar and trying to show our clinical efficacy versus many of the other technologies that are out there today. So we're gonna look to expand reach into other natural areas for us.

For instance, the amnio side, which is something I mentioned a little bit earlier, as well as the dermis side, which gets us into another end of biologics, which is good as we start to expand where we go after, but then improve the existing offerings of the products we source today. So stem cells, growth factors, synthetics, all these are things we're bringing in-house, and so they will not only dramatically improve our margins, but we think we're gonna have a dramatically better product. Similarly, so when we think about our spinal hardware, this idea of motion preservation, the idea of trying to make sure that we maintain the joint by which we're trying to fix, rather than literally fuse it, which is, I think, the worst thing possible.

So that's when you look at our Coflex and CoFix, along with the DCI product, which is here in Europe, and we're bringing it in the United States, the same with the HPS. Certain parts of the HPS system is already FDA cleared. We just got it. There's a coupler system that we wanna bring back that actually can be used in almost any other spinal fixation construct. They can actually use our coupler to help preserve more of that motion. Pillar number two, expanding our distribution network and our access, right? So job one is increasing contractual access. If you don't have contracts, you don't get into hospitals, right? You're just not gonna be able to work. Happily for us, we have every major GPO, so therefore, we you could argue that we're in every hospital in America.

Not every hospital necessarily recognizes their Premier or their VHA contract, or I should say, their Vizient contract. What they may be looking at instead, so is those IDN agreements. So today, we have over 450 IDN agreements, which again, covers about 90% of the beds in America. When you look at also having those DoD and VA access opportunities, especially for our Coflex business, as we work on, improving our reimbursement, those are some areas that really help us in that way. Step two is building a national network. And so now with 650 distributors through our Surgalign acquisition, the Surgalign acquisition brought us about 200 new distributors. So at the beginning of last year, we only had about 300. So at the beginning of 2023, we had about 300 distributors.

We picked up about 150 more when we bought Coflex, and we picked up over 200 more when we picked up Surgalign. So now we have a fully national distribution network, where prior to, you know, a year ago this time, we probably covered three-quarters of the United States. Now we have the entire United States covered. So when we think about our third pillar, our third pillar gets into adjacent markets, the adjacent markets that we serve, and this is really our OEM opportunity. Today, our OEM goes from anywhere from 7% of our sales to 9% of our sales, depending on the quarter.

There are some significant opportunities for us still, though, when we make a product, same product we make for the spine world, that we can then actually sell within the ortho or within the oncology space, ortho-oncology space, foot and ankle, trauma, oral maxillofacial space. Those are areas that we currently sell today. Additionally, we do a fair amount in the sports medicine world as we harvest tendons. So tendons that would go into ACL reconstructions and things like that. That is an area that we do fairly well within the sports medicine side. But another big area of opportunity for us is the wound care market. Now, what I say about this is that I don't care to be an end manufacturer.

All I want to do is say, all I want to do is manufacture and sell to the people who are gonna manage the reimbursement, all the other pieces of this. There's a fair amount of business that we can, we can pick up from there as we bring on this amnio product, and it's very profitable as well. So pillar four is really the integration or of enabling technologies. So when you think about the companies that are out there today, especially when we think about the roll-up that we've just done, three different businesses over the course of the last year, we see more and more technologies that are undercapitalized or subscale or quite frankly, have taken on too much debt. And so they find themselves in a pretty tough spot.

From our side, I think we sit in a really nice place because A, we're a publicly held company, B, we've got access to more cash when, if we need it. But then C, I think when you look at being able to give somebody not only an exit, where they get a fair, you know, price for their business today, but based on the way our business has really over the course of the last year and a half, you know, we've tripled in value in way of our market cap. So it's something that at least tells a pretty darn good story for these companies as they start looking for ways in which or just looking for exits as we speak. So when we think about our pipeline, we think about really kind of three big things.

I usually call these the three Cs, but we changed that now. So it's capabilities, capacity, and profitability. When I think about capabilities, really anything that's gonna help us develop and become higher end, at least when it comes to the biologics, and/or helps us further this motion preservation side of things as we look at what we want to do in way of helping, again, that story and building the business of the franchise that we're creating within our hardware space. Second, capacity. The way we're growing, you know, organically, we grew 18% just this past quarter, 15% the quarter before. We're doing very, very well, not only growing through inorganic means, but also organically. We can see a time where we're gonna need more space, more space for production and other things like that.

We'd like to buy the space with more capabilities, too, if that's possible. So if you combine those two, that'd be great. And then last but not least, profitability. Whether it be a standalone business that's profitable today or very quickly after we buy it through the synergies of what we do and what they can perform for us, we get them to profitability is really part of what we're trying to find as we look at our acquisition pipeline. So in summary, what you're looking at is a business that's really leaning forward, right? We got an outstanding platform for growth. We've got a roll-up strategy that's really starting to take hold. We've got a board and a chairman.

Our chairman is actually somebody who came on about a year and a half ago in August of 2022, Stavros Vizirgianakis. Stavros has had a great run with a number of different companies. He's just been absolutely fantastic. Quite frankly, since Stavros has gotten here, the value of our business is actually tripled just because of his, not only his investment, but his guidance, and he's been really absolutely terrific. So we have a very, very, very invested board. Operationally, exceptionally strong, proven management team, expanded capabilities. Our margin profile, a year ago, we were in the mid-50s. Now we're in the low 60s in way of our margin. By the end of next year, we'll be again in the mid- to, let's just say mid-60s.

Then in 2025, our hope here is that we'll be over 70% based on what we're gonna be doing with our just the products that we'll be producing internally. And then last but not least, financially, very strong, 70+% growth this year, cash flow positive, clean balance sheet, so we have very little debt. And so as a business and as a future prospect of a company, I think we're going down the right path. Okay, I'll end there. What questions can I answer from this super crowded room? Oh, excellent. Yes.

Operator

What's the regulatory environment for the biologic side? Is that changing at all? Because I imagine your donors are cadavers.

Sean Browne
President & CEO, Xtant Medical

Yes, they are, the cadavers. That's correct, yes. And so the regulatory world is actually one that we wish was tighter because we, we are actually an ISO 13485, so we're, we, we have a medical device clearance for what we do. But most of it, it's what they call HCT/P 361, which just basically says you're not gonna be doing any type of, it's just, again, it's a very, very, very low bar. I won't get, I won't bore you with all the details, but the regulatory pathway is one that's very, very low. Now, if you want to step it up and get into the next level, unfortunately, there's no middle ground. There, it's, it goes from, goes from a, this 361 category, all the way to a BLA, which a BLA is even more involved than a PMA.

So it's the FDA created this BLA, and to date, they've had it for, let's just say 20 years, not a single product has ever passed a BLA. So it's there needs to be something in between, but unfortunately, everything that's down below, there's just not enough clinical requirements. Again, processing a human cadaver, putting a product out there, and it's very, very good, still very effective. It's just there's more that can be done there.

Operator

And one more.

Sean Browne
President & CEO, Xtant Medical

Oh, yes, please.

Operator

During COVID,

Sean Browne
President & CEO, Xtant Medical

Yes.

Operator

How did the supply side change?

Sean Browne
President & CEO, Xtant Medical

Sure. It definitely changed much of what people were looking at at the time. So like anything viral, so anytime somebody dies of a virus, that patient can no longer be a donor. So yeah, it impacted, especially in America, considerably. And so that's one of the things, and we are very, very, very tight, especially as a publicly held, for-profit company. Most of the people we compete against are not-for-profits, right? And so their bar or what is, what we have to, with the kind of scrutiny we come underneath, we have to be very, very, very high-end with respect to the donors we take on. So yes, excellent question. Okay, any more questions? Well, thank you for the time, and can't wait to see your presentation.

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