Well, we're on the last day of the 46th Annual TD Cowen Healthcare Conference, we are at the end of the morning track of company presentations and fireside chats. We're thankful to have the executive team from AVITA Medical coming out east and participating this year. I'm gonna hand it over to CEO Cary Vance for presentation, and then there'll be time for Q&A after. Cary, thanks so much, and looking forward to hearing some updates and then diving in with some Q&A after your presentation. Thank you.
Yeah. Real good. Thanks, Josh. We appreciate the invitation. We're glad to be here today. Again, I'm Cary Vance. I've been the CEO for about 4 or 5 months. Before that, I was on the board for a few years, chair of the board. Really excited about our company and about what we're planning to do this year. Again, AVITA Medical, for any of you that aren't familiar, we're an acute wound care company. Again, the wound care space gets a lot of press these days, but we're in the acute wound care space in the hospital-based. That's an important distinction with what we're doing. Forward-looking statements. Again, we are a procedure-driven company. Burns, surgical wounds, traumatic wounds, that's the space we play in with burn surgeons, with trauma surgeons.
There's about 120 burn centers in the U.S. and about 50, 60 level one trauma centers. That's where we're focused. We have about 50 some reps in the field, maybe 80 total. They're focused on those accounts really exclusively. Opportunistically, we may call on some others. That's where we're focused. We're in most of those accounts. What's important is that they're currently using our RECELL product, which is our flagship product that we'll talk about in a minute. They know those accounts. They're familiar with AVITA. It's a matter of going deeper and wider, more types of procedures, more physicians using RECELL. We have two fairly new products called Cohealyx and PermeaDerm that we'll talk about in a minute.
The idea is to be in the same wound, the same physician, the same hospital, and just get more economics in that wound and also be able to care for it more clinically per procedure. These are the three products. Again, RECELL's gone through an evolution over time, so it's gone from a more manual process and manual product to a more automated product that we call RECELL GO. Then we have a product called RECELL GO mini, which is for smaller size wounds. It's basically taking a small donor site of skin and putting it through the device, and then it chops it up, I guess, and mixes it with an enzymatic solution.
You're able to spray that onto the wound, and it's a more uniform cover, better from a pigmentation standpoint, pliability standpoint, all of that. Again, a smaller donor sample. Cohealyx is a collagen dermal matrix. That's used in the wound to vascularize the wound, prepare the wound bed for grafting. One of the clinical benefits of Cohealyx is that it is quicker to get the wound ready for grafting than other competitive products. That's really important because as a whole, the company kinda is all about speed. Speed to healing, speed to grafting, speed to getting patients out of the hospital for their benefit, for the economic benefit of the hospital as well.
PermeaDerm is a temporary biosynthetic matrix, and so that temporizes the wound and allows them to see the wound, how it's progressing, and it protects the wound during the process as well. Again, this is somewhat of a graphical explanation of how these three products could be used on different types of wounds or in concert with each other. You see that sometimes PermeaDerm can just simply be used to cover the wound and to treat the wound by itself. You see in the middle there where you might have RECELL and then covered with PermeaDerm. Finally, all three products can be used, Cohealyx to vascularize the wound bed and then RECELL sprayed over the top with a split-thickness skin graft and then PermeaDerm as well.
You can also see the economic benefit for the company, that same wound, same physician, same patient, same hospital, but the economic benefit for us and the clinical benefit for the patient goes up dramatically when all three products are used. This is an example. We have two studies, post-market studies going on right now, one for Cohealyx, one for PermeaDerm. It's a post-market study, they'll be published towards the end of the year, but we can use that data throughout the course of this year, including at some of the key conferences. This is 1 of the case studies that was presented at the Boswick Burn Conference. This is a 91-year-old female, which is important, as anybody that knows skin, older people, wounds, they don't heal very well at all.
Most 90-something year olds, they walk around with open wounds here or there all the time. It's a really difficult case. This woman fell, and then there was a wound, and it's basically a wound where the skin layer separates from the muscle, and there's a gap there. You can't it won't go back together. What'll happen is that skin will start to die, and it needs to be treated. In this case, what you see is this is where the injury is. This is where the donor site is. That donor site is a combination of a very small amount of tissue taken to use with RECELL for spraying and then a small amount of sample that's used, and I'll show you that in the next slide.
What's important is that RECELL and PermeaDerm are used on the donor site. Most people don't talk about the fact that they take a donor site with RECELL. It can be thinner and smaller, which is important. Also you can treat that donor site with RECELL so that it heals well. Because quite often they'll take a donor site, it'll be painful, it won't heal very well as much as the wound doesn't heal very well. On the injury itself, we use Cohealyx as well as RECELL. Pardon me for these pictures. This is the wound itself. You can see the necrosis of the skin. The skin's dying. All that needs to be cut away and excised. Here they've done that down to the fascia. Next, we put Cohealyx. This Cohealyx right here, used again to vascularize and prepare the wound bed.
Then here on the right, you see that is a really nice-looking wound bed, nice and red and vascularized and ready for grafting. Then they use this... It looks kinda meshy. What you see is they took a piece of skin, and then they put slits in it, and they kinda spread it out. What fills in the gap of that kinda meshed-looking skin graft is RECELL. It fills in all the gaps and makes it heal really well and really uniformly. On the right you see it is really a beautiful result on that wound, especially, like I said, for a 91-year-old to heal in that way is amazing. On the donor site itself, it's basically spraying some of that RECELL on the donor site and then putting PermeaDerm over it as well.
Again, just a few weeks later on the right, both the donor site and the injury site, looks beautiful for this 91-year-old woman. As a company, we have a large market. We have a very targeted market, though, as our company. You have a TAM of $3.5 billion, but within a very focused, kinda strategic TAM of $1.3 billion as we go after these 200 accounts in the U.S. 90% of them, like I said, we're already active in those accounts. We're very under-penetrated in terms of our accounts. We're less than 5% penetrated across our portfolio. Even within RECELL, we're at about 15%, which is really under-penetrated. We are early days internationally.
Our focus is on the U.S., but we do have a distributor in Australia, in Japan that we've been at for a while. We're looking to accelerate our efforts there. Then in Europe, we're early days in a handful of countries there with new distributors and a new approval there late last year. The Swiss nightclub fire New Year's Eve really brought attention to the fact that these countries need better treatment. We've already treated a couple dozen patients from that fire in a few different countries, which I think is important. It's good for those patients, but also from an awareness standpoint, that was key for us. We're a very clinically based company from a data standpoint, and so for us, we use a lot of different clinical studies.
Last year and this year, I already talked about the Cohealyx-I and PermeaDerm-I clinical studies that we'll be using throughout this year. It's important from an economic standpoint, from a clinical standpoint for the convincing of hospitals and physicians and so on to understand what our products can do for them. Again, for us, I became CEO in October. We really needed to stabilize the business, really understand how our customers buy at the rate in which we intend for them to buy to get through the VAC process on Cohealyx and PermeaDerm. We've done that. I think we understand our business. We're becoming very predictable. We've become very predictable. I think we understood in Q4 how that year was gonna end.
I think in Q1 here, we understand here just, you know, three, four weeks before the end of the quarter how it's gonna end. So the idea is once we've got control over our business, which we have, once we become predictable, is to accelerate everything, and we're in the process of doing that. You can expect, if nothing else, you can expect sequential growth quarter after quarter throughout the course of this year. Speaking of growth, I mean, this is a company that over the last five years has a CAGR of, you know, close to 30%. Last year, we would call it a flat to down year. We had a lot of headwinds. We had Salesforce kinda reconfiguration. We had issues with physician reimbursement through CMS kinda not doing what they had committed to do in terms of paying physicians.
That was really disruptive and caused some confusion. We also have Cohealyx and PermeaDerm going through VAC committees, which always takes a little bit longer than you anticipate. Because of that, we had that 11% growth piece. Our expectation is we get back on that track in 2026 as we've removed a lot of those headwinds, and they actually become tailwinds this year. We also have some cost discipline that you can count on. I think for us, we're positioned to grow, but we're from a cost standpoint, very steady, very responsible. We've had some reductions, but we've done it in a very strategic, smart way around our Salesforce, how they're configured, how they're focused.
The expectation from investors going forward and anybody involved in the company can be that it's gonna be very steady state as it relates to cost, and it's gonna be an accelerated growth curve as it relates to revenue. Again, the word, the overused word I use internally and probably externally is execute. It's easy to say, but can be difficult to do. I think we're very well-positioned. We have a very talented commercial team, very talented group at the company. It's probably been the most positive surprise for me coming into the role, how talented our people are, how passionate they are about what we do, and they really just needed our help from a leadership standpoint to clear the lanes for them to succeed.
I think we've done that for the most part, and my expectation is that they will do that, and they're in the process of doing that even as we're two months into the year. With that, we'll take some questions. Josh.
Thanks a lot, Cary. Feel free to take a seat if that's more comfortable or remain standing.
Sure. Let's sit.
Okay, great. Well, thank you for that presentation and, sets a excellent foundation or base for this discussion.
Yeah
There's opportunity to ask questions from the audience as well. Maybe to start, you know, 11% growth last year.
Yeah.
Not what was expected at the beginning of the year, but considering all the challenges that your team was facing, it's a pretty impressive result. Maybe just help us understand some of the dynamics of getting that 11% growth. Our assumption is that, I mean, mostly resell-
Yeah
That was still chugging along despite some of the MAC, I guess, disruption in the momentum there. It sounds like your commercial team, as you relayed on your presentation, is outstanding and they fought through some of those headwinds to still deliver double-digit growth for the business.
Yeah. I mean, I think that, I think that says a lot about not just our team being able to fight through that, but also our customers. I mean, our customers are rooting for us. I don't know that you always have that. They really love the product, especially RECELL. They believe in it. It's been a gift for them over the years to really help them with their patients. I think they've helped us fight through this. I think the biggest thing is we changed guidance twice during the year. We lowered it, then we lowered it again. By the time we lowered it the second time, we actually hit that guidance. I think that's another thing, is we knew how Q4 was gonna go.
Knowing how Q4 is going to go and knowing how 2026 is going to go is a big deal. Once you know how it's going to go, to make it go a little faster and to make it go a little bigger. I think that 11% growth is a testament to how valuable our products are. Even though they're early days in Cohealyx and PermeaDerm, I think that the team accelerated a lot of those through the VACs, and we're seeing some of those come out. We probably in Cohealyx, we have about 55 of them in VAC right now. We'll probably see about 12 of them come out this quarter, and I think that will happen throughout the course of this year to the point where we'll be done the way that we're done in VACs with RECELL.
It'll just be a playing field we'll be able to participate in and compete in.
Excellent. Reimbursement challenges are never fun.
No
Until they're in the rearview mirror, and then-
Yeah
You have a little bit of a softer comp. Maybe to first address those reimbursement challenges. Are they fully in their rearview mirror? I mean, we talked a little bit about this on the earnings call recently.
Yeah
So it's not that long since then, for an update, maybe just talk about where you are and how investors that are new to the story understand where that dynamic stands with the VACs.
Yeah. Yeah. I mean, I think there's two pieces to reimbursement. One is what the hospital gets. Hospital gets a certain DRG, and it doesn't matter if the patient's there for two weeks or two months, they're gonna get a set amount. For us, what's important is to get that patient out of there sooner, healing better, healing faster, and that's what RECELL does. That's a big talking point for us with hospitals. From a physician payment standpoint, what's frustrating about it is we did get a CPT I code. We did everything we were supposed to do, and frankly, CMS dropped the ball. When they handed it off to the MACs, they dragged their feet.
A lot of times when I talk to people in Washington, D.C., I talk to them about how disruptive delay is to a company, a small company, and how it hurts patients really because they don't get the care that they need. They split it off into the seven MACs. Probably three of them by the time we got to Q3 had published. Another three have now published, and we have one that we're still working on. Even after they publish, sometimes you have to tell physicians, "Okay, you will get paid going back. You will get paid," and sometimes they don't believe you until they get paid.
It's just this process, this sometimes painfully gradual process of getting back to whatever normal is and making sure they know they're gonna get paid and what they're gonna get paid. We're most of the way there, but it's still a process, I'd say, over the next few months that gradually we'll get back to that clarity that will help us in the field.
Would it be fair to assume that, I mean, if there's a kind of percentage of recovery for RECELL and with this reimbursement dynamic, MAC dynamic, you guys are 70%-80% back?
I would say that's a good number.
Great. Again, over the next couple months, get to that 100%.
Yeah
And back to full thrust forward.
Yeah.
RECELL, the feedback we've gotten over the years from burn trauma surgeons around RECELL has been incredible.
Yeah
As you're well aware and as you disclosed or relayed on your presentation. Maybe help us think about what's baked into guidance. Clearly, the recovery, getting that 100% on the reimbursement front and recovery there, but then just you talk about 15% penetration at these 200 burn center accounts. How do you drive deeper penetration?
Yeah
And drive stronger RECELL growth as we're here in 2026 and out into 2027 and beyond?
Yeah, I mean, I think it's important to understand what's baked in because I, again, I don't know how it's been done in the past, but I do know that we're very bottoms up, understanding the dynamics of how much and when. I think we took some of the. If you took 70-80 and you applied it to what we thought it could be, and then you said at what point in the year and how many, you know, if a hospital starts ordering RECELL again or starts ordering RECELL for a certain physician, but they do it in, again, in March versus October, it's a big deal for the numbers.
We put all that together as well as the VAC timing and the uptake in Cohealyx and PermeaDerm kind of by physician, by hospital, and how much we expect from that during the year. I think that's where we get to our guidance. When I look at the numbers, $80 million-$85 million, those are dollars, of course, but I almost see those as timelines. If we can get things done quicker than we think, then hopefully we can hit the top end of that plus. If things go a little bit slower, we'll be on the lower side. To me, it's all about speed, it's all about conversion sooner rather than later in the year. We have a tremendous sense of urgency. We're not just tiptoeing into the year.
We're really trying to accelerate things from the beginning.
Excellent. Just to circle back on that 15% penetration in these-
Yeah
Core accounts, suggests there's a lot of runway for RECELL over the coming years. My historical kind of baseline was that RECELL was being used in big TBSA, total body surface area burn cases.
Yeah.
You guys have been you know, moving down that.
That's right.
TBSA ladder to the lower percentages.
Yeah.
How's that progressing, and how do you see that progressing-
Yeah, it's progressing.
Over the coming quarters?
There are the two main reasons why it's progressing. Number one, we came out with RECELL GO mini, which is smaller, which is a little less expensive for smaller wounds, which is kind of responsive to them and saying, "Well, listen, you can use something that fits the wound." The second thing is the economic benefit. The study that shows that by using RECELL, you're able to heal faster. A patient's able to heal faster and get out of the hospital 36% sooner. The economic benefit of that, even if it's on a smaller wound, makes more sense to them than maybe it used to. They're a lot more open to using it on smaller wounds. A lot of our key strategic hospitals have made it standard practice to use it on smaller wounds as well.
Instead of just that 20% or over, that 10%-20% and working their way down, as you said. The economic data, the speed at which people are healing and getting out of the hospital and then giving them an alternate product in RECELL GO mini for the smaller or more complex wounds, are ways that we get into that instead of being 15% penetrated, 20%. It wouldn't take much. You get to 20% penetration, it really impacts the number quite a bit.
Absolutely. That's just in burns, right? I mean...
That's-
You still have trauma cases or other wounds.
Sure. Yep.
That, maybe just talk a little bit about that segment, 'cause you do have some of these 200 centers.
Sure
That have both burn and trauma-
Sure
Trauma centers combined.
Yes. Yeah, a lot of them are one and the same and but yes, you do have new surgeons. I mean, again, the penetration piece isn't just having different sized wounds or different types of wounds, but different physicians. You might have certain physicians that have been using RECELL forever, but then some that don't, and some of the reason why some of them may not, it may be political, it may be that, you know, they need more convincing around the data. It could be because a workflow issue that they just need overwhelming amount of pressure from their peers or from an administration around the economics or whatever it is that gets them to convert. It's all of that. When it comes to trauma surgeons that aren't as familiar with RECELL, kinda how to use it.
A lot of these surgeons, this is as much art as it is science. Going to the Boswick Conference, you see they put up a wound. This happened to this patient. This is what we decided to do, and it's not always straightforward as to when you use RECELL, if you use RECELL, when you might use Cohealyx, when you might use them in conjunction, when you do. For us, it's a matter of being a consultant, and we have a very clinically based sales team. They're really good at selling, but they're also really consultants to that surgeon. A lot of our reps are even former burn nurses that worked with those surgeons.
They're used to being in consultation with them about a particular wound or a particular patient as to how they might be treated and how you might integrate our products in that. That's all a process of getting them more familiar in the trauma space, for example, that getting them as familiar as the burn surgeons are.
The, you know, the strategy to build the portfolio out, add Cohealyx and PermeaDerm.
Yeah.
You see that there's a clinical benefit for patients, and as you've demonstrated clearly a big economic benefit for.
Yeah
For AVITA. got Cohealyx-I, PermeaDerm-I studies.
Yeah.
Those will help with the adoption ramp. You guys are moving through the VAC processes, but maybe you could just help us think about some centers that have Cohealyx and PermeaDerm approved. I know it's still very early days.
Yeah
How are you seeing that early kind of utilization after adoption is in play and VAC approval has been in the bag?
Yeah, I mean, I think, we do have centers. I think maybe 11 or 12 of them that currently are using all three products. You saw the case that I put up. That was an example where they use all three of those in concert. I think it's, each of those products needs to be able to compete on their own. PermeaDerm needs to be able to compete with the, you know, half a dozen or so competitors out there, even if they're not using RECELL very much or whatever. I think in conjunction, sometimes you give clinicians a product or a set of products, and they even find better ways to use them than you had thought.
The idea is for us to do a lot of best practice sharing, those dozen accounts that are using all three, finding new ways. Not every wound is the same. A 91-year-old woman is different than a nine-year-old boy in terms of how they heal or what type of treatment you might wanna use. I think what we're finding is a synergistic effect with the three products themselves. I think more and more will come out as to not only how they have a clinical or an economic advantage, but also how using all three not only helps the patient heal better, but also gets them out sooner.
If you think about the 36% data on RECELL and getting them out sooner, you add Cohealyx in terms of one week to graft versus three week to graft in the competitors, you kinda start adding all that up and you get it into speed of healing, people getting home sooner, hospitals saving money. I think all that has a snowball effect.
Cohealyx- I will be a data set that your commercial team will build a market, and I'm sure there's gonna be solid reception, assuming that those results are positive.
Yeah.
Which I think there has been strong clinical, preclinical, and even initial case experiences that provide a strong signal for that study to be a success. In these early days, you'll have Cohealyx- I data as well, but the pricing strategy stands out to us.
Mm-hmm.
I mean, 'cause you guys are trying to go up against established competitors in this dermal matrix space.
Mm.
You guys, I think, are offering, a potentially a premium product for at a maybe discounted price. Is that right?
Yeah, I mean.
Is that the strategy you guys are employing?
I think it's a penetrative price.
Penetrative price-
I think that.
Price point. Sorry, yeah.
I think the elasticity of each of the products, and of the portfolio as a whole is to be determined somewhat, considering how new it is and even just early days in terms of call points. I do think obviously we'll be opportunistic about where we're priced. We definitely wanna, we wanna make inroads from a penetration, in the market. I think it's kinda to be determined on the price we like where we're at, but, we'll make sure we're always where we at, where we need to be at, to get that market share we're looking for.
Understood. Just as we are working our way towards the Cohealyx -I and PermeaDerm-I study results, I mean, are you seeing any trends? I mean, is PermeaDerm maybe being utilized a little bit more frequently ahead of data, or is it an even balance? Actually in your slide, I had failed to kinda think about the use of PermeaDerm in donor sites as well.
Yeah.
Which is a whole another layer for us to think about as we're building our revenue model out.
I mean, I think PermeaDerm, a lot of what'll come out of that study is an economic advantage. There's a lot of counts that don't need a study to tell them that versus allograft, it's less expensive. We had a lunch symposium at the Boswick Conference where we had a physician basically say he thought that they could save a half a million dollars. It is a heavy user, but they could save a half a million dollars a year by just switching from allograft to PermeaDerm. He's standing there in front of a lot of different physicians saying that's as powerful as any study's gonna be.
Great. We just have a minute left here. I mean, not enough time to discuss margin and profitability.
Yeah.
Path to profitability. Maybe we can just touch on that-
Sure.
Maybe please, we can bleed in a minute if we can.
Yeah. I mean, I think, you know, PermeaDerm and Cohealyx, because of the agreements that we have, we're at about, you know, more or less 50% margin basically on those two products. The more that they dominate, our revenue is gonna take the margin down a little bit, except for the fact that RECELL is gonna grow as well. That ratio is always gonna be so dominantly RECELL that we're gonna stay in the 80s, the low 80s for quite a bit of time. I think from a profitability standpoint, we're not giving guidance there, but you could probably do the math on an 80-something% margin product, what our cash use is, and what kind of revenue we need to get at before we kinda cross over.
It's coming. We're on the cusp of it, really. If we just continue on our growth trajectory that we expect, it's coming.
Well, it's excellent to hear about the stabilization and it sounds like some nice momentum here in this recovery, and then getting to that 100% over the couple of months on the RECELL side and the reimbursement dynamics.
Yeah.
2026 could be. Looking forward to tracking you guys. It's gonna be a big year.
Yeah. Well, I agree. I mean, I think there are a lot of things we'll talk about this year, but what I expect we'll talk about more than anything is just the numbers, and we're comfortable that our strategy and our execution will bring us sequential growth throughout the course of the year, and we just invite everybody to watch the numbers.
Cary, thank you for this time here today. Thanks for coming out east, participating.
Yeah.
In the conference, and good luck with the rest of your meetings today.
Thanks, Josh. Appreciate it. Thanks.