Morning, everyone. Thanks for joining for another day for the Canaccord 46th Annual Boston Growth Conference. This morning, we are joined by Cary Vance, who is the CEO of AVITA Medical. Cary, I am really pleased to have you here, and we might do 15 minutes of a presentation, and then we will get into Q&A. Thanks. Thank you. Good morning, everyone. It is good to be with you. Again, Cary Vance, the President, CEO of AVITA Medical. I have been the CEO for about 10 months and excited about what is happening at the company and sharing that with you today. AVITA Medical is a hospital-based acute wound care company. That is important distinction between ourselves that we call on hospitals and acute wound care locations, as opposed to the chronic care space in offices. That is an important distinction of where we play and where we do not play. Our products are repeat use, and so we build a book of business with facilities and physicians that use our products on the same patient. We have three products, and I will talk about those in a minute, but essentially, those three products are used on the same patient, the same hospital, same physician, which makes it highly efficient for our salespeople and effective in terms of synergies in our portfolio. We are focused on approximately 200 centers in the U.S., about 120 burn centers, about 55 to 60 Level 1 trauma centers, and then opportunistic about another, say, 20, where you might have a reconstructive cosmetic surgeon that uses our technology as well. We have a $1.3 billion addressable market for our portfolio in the U.S., about the same addressable market outside the U.S. as well. Again, joined the company as CEO after serving on the board for a few years, last October. You can see the growth path over the last couple of quarters that we have reported out from $17.6 million to $19.3 million to $21.7 million. If you go back and look at transcripts of earnings from last November, February, and May, we have been pretty consistent about what we expect to stabilize the business, to understand and put it on an organic growth trajectory, quarter-over-quarter sequential growth. That is what has happened over the last couple of quarters, and you can expect that to continue to happen, and we will talk more about that. In the U.S., we have just started to break out our portfolio and the different products. We have U.S. RECELL, international RECELL, so internationally, we only sell RECELL, and then Cohealyx and PermeaDerm. You can see we are growing in all three product lines, both U.S. and internationally. We raised our guidance as a result of our growth path from $80 million to $85 million to now $86 million to $89 million this year, and that's what's expected. Importantly, also, as we grow revenue in sequential quarters and we hold operating expenses consistent, we hold margins consistent, we expect to be cash flow breakeven in the fourth quarter of this year. This breaks it down again beyond revenue to margin expenses, net loss. We're a very simple business. We have three product lines. Consistent high margin business, consistent operating expenses. You can see they went down year-over-year, but stayed pretty much consistent quarter-over-quarter. We expect that to continue for several quarters ahead. We don't expect that we'll need to add OPEX as we grow. We're built to grow, and we'll talk more about how that is the case especially from a commercial standpoint. You can see the kind of dramatic reduction in use of cash. Again, we expect that to continue as we grow in revenue and hold consistent our OPEX. We have as of the end of the second quarter, $11 million in cash available as well. These are the three product lines for those of you that aren't familiar. If you think about a patient that comes in, I'll start from the bottom, actually. A patient comes in with either a large burn or a traumatic wound. That wound needs to be cleaned and excised, and then our PermeaDerm product is used as a biosynthetic dressing, a temporizer. It's transparent, so you put it over the wound to protect the wound, to assess the wound before you make some decisions about how you're going to close the wound itself. Cohealyx is a dermal matrix. That is used as you're preparing the wound bed. If you have that wound, what you're trying to do is vascularize the wound and get it ready for grafting. You need that well vascularized and prepared. We have Cohealyx, and then RECELL is used either by itself to spray on skin cells or in conjunction with a split-thickness skin graft or meshed skin graft. Within the RECELL portfolio, we have three products. One is our manual RECELL product, which people continue to use, those that have refined the technique to using RECELL, and then RECELL GO, which is an automated version, and then RECELL GO mini, which is a smaller version for smaller wounds. This is an example of a woman who had initial treatment that failed, and then the use of RECELL not only helped her to heal very effectively in terms of an outcome, but you can see the return of pigmentation, which is a key feature and benefit from using RECELL versus a skin graft. On the right side, you can see that not only did revenues increase in RECELL, but volume increased as well. You can see quarter-over-quarter from Q1 to Q2 how that happened. We developed RECELL GO mini to address smaller wounds, and that's exactly what it did and has done. You can see the size wounds that RECELL GO is addressing. The way that you expand from large wounds or large burns to smaller wounds is, some of it is education, some of it is them understanding the advantages from an economic and outcome standpoint, but also some of it is product driven, and RECELL GO addresses that need that they have. It is important, reimbursement is always key to traction in the marketplace. Over the last year and a half or two, we have gone through kind of a stopgap in terms of getting physicians paid. About a year and a half ago, CMS delegated that to Medicare Administrative Contractors in the U.S. That was somewhat of a temporary way for them dealing with reimbursement. We will talk more about that later, but essentially January 1st of 2027, it does go to a simplified nationwide reimbursement, which all our clinicians and hospitals are very excited about. Essentially, not only do clinicians use our three products to provide better outcomes, to assess the wound bed, to prepare the wound bed, to treat the wound itself for healing and closure, but there is an economics to it for our company. Two years ago, if you had a certain patient that would come in, we could offer them RECELL, and that would be an effective way of healing that wound. But now we can offer all three products depending on what the patient needs or the clinician needs. You can either use PermeaDerm as a temporizer to cover the wound, you can use PermeaDerm plus RECELL, or you can use all three products to cover the wound, protect the wound, assess the wound, prepare the wound bed, vascularize the wound bed, and then spray the wound bed for healing. You can see the resulting revenue that can come from the same patient, same physician, same hospital. For our salespeople, it is very efficient. They are in these cases. They are having conversations with physicians about using it, all three products on different types of patients as needed. Right now, we have about 25 hospitals in the U.S. that use all three of our products, which is very encouraging. We are a data-driven company. Some of the data is clinical, and some of it is economic. Both are important to our clinicians in the hospitals as they assess using our products. The data on the left shows a 36% reduction in length of stay for patients that use RECELL versus a split-thickness skin graft. You can see the impact that it has on the amount of time the patient is there, how soon they get to go home, but also for the hospital in terms of how long they have to take care of that acute wound patient. From a Cohealyx standpoint, what we are looking for too is speed. Speed to graft readiness. The study shows that up to 20 days difference between us and the competition in other dermal matrices, as little as five days in wound bed readiness. PermeaDerm is fairly straightforward. As a temporizer, we compete against Allograft or cadaver skin, and so having that be comparable and in some ways very advantageous in terms of handling and visualization, but also in terms of just straight cost in using PermeaDerm versus cadaver skin. We have a couple endpoints to our clinical data around safety, but also around cost and workflow. Essentially, the company is built to grow. It's a very simple company, and I think as CEO, I've tried to keep it simple and very focused. Focused on our markets, focused on our customers, focused on what makes a difference to them in terms of their patients from a clinical perspective, from an economic standpoint, from a workflow standpoint. Make our products really easy to buy and really easy to use and make the company really easy to grow. With that, I'll take questions. Thanks. Thanks, Cary. I think the point that I just want to sort of emphasize is that you've obviously had some reimbursement challenges in the last 12 to 18 months. Is there any sort of lingering concerns and just maybe a little bit more color as to what it looks like- Sure from now on? Sure. I'm really proud of the team, the way that we adjusted. I think what occurred in the first quarter of 2025 was not our doing, was not our fault. CMS essentially said, "This is a little bit more complicated than we'd like. Go back and simplify it." They delegated it to the MACs. We approached the MACs and worked with them. They were very slow to publish. That slowness created confusion and wondering from the surgeons whether they would get paid. That tends to impact their use. We worked through all of that, and over the course of really a year, they all published, they're all paying, everything is fine. The expectation two years ago was that there would be one simplified national code. Clinicians and American Burn Association in support of the company worked with CMS to have a very simplified, robust code that starts January 1st. They have all expected it. It is happening. They all know it is coming. We do not expect any disruption as a result of it. We actually expect a lot of excitement around how simple it is and how accessible it is for them and their patients from a benefit standpoint. You have had a really good quarter that you just released. Has that been sorted during that quarter? What does it look like during that quarter? Yeah. Yeah. It is a combination. You remember that last year there were some people that stopped using it because of it. Some people stopped trialing it, and those people, again, beginning of this year, started trialing again. We have new RECELL users as a result. The growth of the company, which is great, it comes from all the product lines for all reasons. Economic, clinical, RECELL GO, RECELL GO mini, Cohealyx, PermeaDerm. It is really across the board growth story. Yeah. The slide where you are showing if you're adding all products to a patient's wound and what you can then, the ASP per patient Yeah as you use all of those products. Over time, it's obviously early days with Cohealyx and PermeaDerm, but when you think about what you've done with RECELL and the growth still left in that business versus Cohealyx and PermeaDerm, what does it look like over the medium and longer term? Yeah. We're very under-penetrated. We've been out in the market for a while, but we're very under-penetrated. Even in our sweet spot of larger wounds, burn centers, we're still about 15% penetrated. We're almost barely penetrated in trauma and smaller wounds. That's why we have a utilization penetration strategy for our salespeople. They know there are many more physicians to go after to use the product. There are many different types of size wounds and cases that they can get after, so they're in there every day, which provides them the opportunity to sell already where they are and where we already have relationships. You have completed a cost-out initiative. Yeah I think that that's largely completed. Can you just remind us of the number of sales reps, Yeah and how you know what the sales force needs to look like? Are there certain KPIs and metrics Yeah investors can follow? Yeah. The simple part about running a business is listen to your people, listen to your customers, and listen to your commercial leadership. When they tell you they need somebody, they have a business case for doing that. I think we understand how we're deployed, how many people we need to cover different cases. You have some hospitals that are large volume users. They need to be managed. A lot of work goes into supporting them, and then you have some that are extremely under-penetrated or where we don't play much, where there's just a lot of growth that needs to occur. Either way, the sales reps have a lot of work to do, and we assess how much they can cover in terms of geography and in terms of facilities that they can cover. I think we're well-positioned. When we continue to grow quarter-over-quarter, we shouldn't have to add any more salespeople for at least a year and a half or longer. We're positioned to grow because in those facilities they cover, if they're doing twice the business at some point, they can still handle that amount of business. The initiatives that we put in place last year have now helped us from an OPEX standpoint, but they've also positioned us to grow. We didn't sacrifice a thing to do it. Yeah. What is the number of sales reps? Well, again, it is a little bit complicated. We do not give out all our sales rep numbers, but we are pretty much positioned throughout the country. They have about three, four accounts each. Okay Which again, they are in the OR pretty much every day, and multiple physicians within each account, but well-covered in the U.S. Again, for the foreseeable future, that should serve us well. It is probably a tricky question to answer, but when the sales reps are going into the hospitals and it is a new account, how much does data and the clinical data matter to the clinicians versus obviously the VAC and the hospitals making sure that there is- Sure the reimbursement framework? Yeah. I think it's important again to do what works. Data's very important, and that's why we've tried to do some real-world data, some real use cases, even recently some post-market clinical studies around not only efficacy, but from a cost perspective. It's important to understand if you go to a certain physician that is not using our products, you ask them why, and sometimes you have to ask them why three or four times to get to the root of the issue. Sometimes it's workflow. They're not used to doing it. They feel like it might cost too much, so they need to be educated about reimbursement or about length of stay reduction, or about efficacy and outcomes, or about what their peers might be doing. It's really a combination of all of those things. Our sales reps are trained around messaging and around addressing any objections that they might have to either using our products or using it more pervasively across different types of cases. You do have some important data coming out for Cohealyx and PermeaDerm. Yeah. Just before we talk about that data, what is the issue that those products are solving? Yep. Because I did notice that you had a couple of competitors that called out that it was taking share. I know it is early days, but- Yeah can you just explain, when you talk to clinicians, what that is actually solving and why they are liking that? Yeah. I think it's an interesting next step for the company to have a portfolio. RECELL, essentially, the competition for RECELL is the way that they've been doing it for decades in terms of skin grafts. Cohealyx and PermeaDerm do have competition, and so once you address the market, once you get through MACs, that gives you a license to compete, and you're competing against worthy competitors. But we feel like we have distinct competitive advantages and value there. In the case of Cohealyx, we believe speed is our greatest benefit, speed and efficacy of the wound bed. So it prepares the wound bed for grafting. Speed is important. So if you can prepare the wound bed and it's ready in 13 days, it can be as little as five, let's say. That's what the study shows. But let's say 13 days versus the 33 days. Those extra 20 days are 20 days of dressing changes, 20 days of potential for infection, pain, et cetera. 20 days added to the amount of time they might be in the hospital. So for us, the speed to wound bed readiness means a lot for the patients. It means they can go home sooner. It means that they have potential for less complications, and it helps our clinicians as well, and it helps the hospital in terms of how much it costs for them to take care of a patient in acute space. So I think that's the competitive advantage. That's what the data shows initially and will show in the follow-up as well at the end of the year. PermeaDerm essentially is competing as a temporizer against Allograft. If you think about using cadaver skin, the advantage PermeaDerm has is multiple. The endpoints are about being comparable and safe, but also about just straight up costing less money. So it's less expensive. It's transparent. Think about addressing where you're trying to assess the wound, you want it to be transparent. So it is. Allograft is not. It's easier to handle. You can basically stick it on the shelf. Allograft needs to be frozen, thawed, tracked, because it's human tissue. So I think we have a distinct, simple advantage in that area as well, and that's what the data will show. And you mentioned, when you were looking to add these products, was there a sort of pretty broad range of products that you were looking for, and these were the best ones? I think, if you look at the continuum of care from the time a patient comes into the hospital to the time they leave the question is what all needs to be done in terms of assessing the wound, protecting the wound, preparing the wound bed, and closing the wound, and the healing that needs to occur. And that it needs to stay healed in an effective way so that you don't have complications, you don't have them returning, and that they can get out of the hospital sooner. We look at all of those steps and say what types of products address those. Obviously, RECELL addresses the grafting side of it, the closing of the wound, the healing process at the end of it. But there are other steps along the way, and that's when we looked at PermeaDerm and Cohealyx, and I think it's a great addition. Makes our sales force really efficient. They're having the same discussions with that physician within a procedure. You can picture them saying, "Well, we're doing a RECELL procedure today. But in the process, they're using a dermal matrix, and they may not be using Cohealyx. So you have that discussion during the process. But you're already there, you already have that relationship, so it's highly efficient in that way, too. Are there any more products to add? Well, I think we are all about staying focused. We are all about being disciplined, not scattershotting all over the place. I think for us, we are consistently evaluating other products that can add value to the bag. We have great relationships where we have decent touch every day in these accounts and in these procedures. If we feel like we can add value with other products in the years ahead, we assess those on a regular basis. When you think about the competitive landscape, I know the competitive set is different, Cohealyx probably has the most competition. Has there been changes? Is there any sort of latest thoughts on who is winning, losing? Well, we are the new guys. We are the small guys, so for us, we want to take more than our fair share. We haven't seen any kind of dynamics or reaction at this point. We would expect that. Our competitors are very worthy competitors, so we expect to compete. It is as simple as that. We think we have advantages, and we will make sure that our physicians know that, and we look forward to that process. Yep. We've only got a minute or so I'll just pass over to question. Cary, stock's up over 100% at the moment, which is great. When you came in as CEO, jobs had been cost out, really difficult things you saw that you needed to do, and you're still on that pathway- Yeah to work through the calendar. Good question, Will. In case nobody heard that, stock's up 100%. I think that's a step. I think we're pleased with it. I think that this is a process of building this back. I think, again, if you go back to my transcripts, and I'm very comfortable with anyone doing that as well as what I'm saying today and coming back a year from now or a quarter from now. Really tried to assess the business, where the hurdles were, what was getting in the way. That's everything from how our people are paid to why people aren't using more of our products, with assessing our OPEX, assessing our structure. We've made all of those changes. We've really stabilized it. We've become very predictable. The part about all of this that you see the growth, you see the progress, but essentially what is important is we understand what is happening on a regular basis. I know even now in Q3 and Q4 and going forward to next year, what is going to happen. I know that because I understand the basics of the business, our people do as well, and that trajectory, and that is why I can confidently say that we will be cash flow break even by the end of the year. That is why I can raise the guidance. That is why I can talk about sequential growth quarter-over-quarter and what is happening in the business because of the data, because I understand it. I think that is what is important because even though the last week has been great, we report out on Q2, we have moved on. We expect that type of performance to continue, that type of transparency and predictability that builds confidence in investors, and then performing and executing. That is what we are all about going forward. Cary, beyond cash flow break even- Yep which is such an important- It is milestone for any company. Yep. What do you see as the next big step? Well, I think growth is the next step. When you hold margins at 80-something percent, which we intend to do, when you have OPEX that you're holding, it's a simple equation, right? Because you're essentially growing a business quarter-over-quarter. As you grow revenue, you're going to go from cash flow break even to profitability at some point, and that's the equation. That's what I love about the business. It's three products, same call point. It's three or four metrics that provide the kind of progress that we're looking for, that investors are looking for, to be self-sustaining and, again, profitability at some point. Again, low market share, under-penetrated. We have a ton of work to do, but also a ton of opportunity in front of us. Great. Thanks very much for your time, Cary. Thank you. Thanks, everyone.
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