AVITA Medical, Inc. (RCEL)
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Investor Update

Mar 1, 2023

Rudi Michelson
Founder, Monsoon Communications

Good afternoon to everyone in the US and good morning to those joining us from Australia. I'm Rudi Michelson of Monsoon Communications. Welcome and thank you for joining us for AVITA's Investor Webinar. This timing coincides with an AVITA Sydney, Melbourne roadshow this week, and follows on from AVITA's strong Q4 results last week. Let me point out that you can submit questions using the Q&A function, and we'll get to them after the presentation. Presenting today is AVITA CEO, Jim Corbett, and assisted by CFO Sean Ekins. I'll now hand over to Jim to begin the presentation.

Jim Corbett
CEO, AVITA Medical

Welcome, and welcome to actually our.

Rudi Michelson
Founder, Monsoon Communications

Good afternoon to everyone in the US and good morning to those joining us from Australia. I'm Rudi Michelson of Monsoon Communications. Welcome and thank you for joining us for AVITA's Investor Webinar. This timing coincides with an AVITA Sydney, Melbourne roadshow this week, and follows on from AVITA's strong Q4 results last week. Let me point out that you can submit questions using the Q&A function, and we'll get to them after the presentation. Presenting today is AVITA CEO, Jim Corbett, and assisted by CFO Sean Ekins. I'll now hand over to Jim to begin the presentation.

Jim Corbett
CEO, AVITA Medical

Welcome, welcome to actually our second consecutive quarter webinar. Really, although we have worldwide audience, I am doing this, of course, from Melbourne, and I'm really happy to be here, and I'm having a good week of meeting with investors and analysts. Thank you for joining. Some of you may be joining for the first time, so I'm going to begin with a couple descriptions of the company. Who is AVITA Medical? We are a regenerative tissue regeneration company. What we have as a technology is a device that takes, if you think skin grafting, we take an autologous sample. We take one that is, relatively speaking, 30% less than they would normally take for a skin graft. We then disaggregate the cells. We suspend it in a enzyme solution.

We put it in our spray-on applicator. We spray on those cells to the wound. It catalyzes the healing process. The current US indication is acute thermal burns. We have two PMA supplements pending, which I will be discussing in some detail, for soft tissue repair and reconstruction, one additionally for the treatment of the autoimmune condition known as vitiligo. The advantage is, just to keep it very focused, why RECELL is better than the alternative. It's very kind of three steps to think about. First, you take less skins, donor, from the donor. The patients like that, not surprisingly. In fact, they like it a lot. They prefer it, and they want that. The second is really important because it improves healing. The healing has multiple consequences that are favorable.

Healing helps the patient, obviously, get home to their family sooner, helps them leave the hospital sooner, which saves the hospital money under the way reimbursement is structured in the US market where we are currently marketing. It produces less scarring. It's a really significant advantage in the treatment of patients who need a skin graft. We've been using this on the, really the, frankly, the nastiest type of wound, which is a thermal burn. We'll talk more about the indication expansions that we're expecting soon during this discussion. This describes the methodology that I just outlined for you, and you can see how it works from a process point of view. It is a manual disaggregation of the cells that go into the kit that you see in item number two.

I'm going to talk about a great advancement we have underway, that's going to make the use of RECELL significantly easier, require less training for the physician, less training for our sales organization with respect to what they spend their time on, and will increase adoption. A very critical development for the company. Let me take a moment and just try to design what happens with a technology like RECELL as we expand indications. We started, and the reason we started with it, is burns originally was the application for RECELL when it was invented here in Australia by Dr. Fiona Wood. The use of RECELL goes back to the Bali bombings and the extraordinary recovery of those patients here in Australia. That's really the foundation.

That is what we went to do our first PMA study in the United States to demonstrate the effectiveness of RECELL. Currently, we've conducted another FDA study for soft tissue. That PMA supplement was submitted on December 9th. It's under a breakthrough device designation. Now, the breakthrough device designation has benefits. One of them is that you stay on the clock, so to speak, of 180 days unless you have a material deficiency. We have not had notice of that. In fact, we have passed the 100-day mark, which is a very pivotal time in the 180-day process because it is when the company or FDA will request a meeting if there's some misalignment in how the two parties are working towards approval. We have passed that FDA 100-day mark, and we're anticipating a June approval.

The vitiligo study which is treating the autoimmune condition where patients lose pigment. That study was also completed last year and submitted December 16th. It's on a similar Breakthrough Device designation, a separate one, by the way, and we expect that approval in June as well. You'll see out to the right there that there's a comment about reimbursement in office, and that's a re-reference to vitiligo will be treated in office by the physician, and that is a separate form of approval, which we are applying for, and I'll provide some more color on that a little bit later. Let's talk a little bit about the quarter release that we had on Thursday, US time, Friday, Australian, last week.

First, revenue for our Q4 was 37% over the same quarter prior year, which was ahead of expectations. We also announced the availability during 2022 of the ease-of-use device. During 2022, we received approval for burns treatment with RECELL in Japan from the PMDA and achieved reimbursement. We published the top-line results for soft tissue repair and for vitiligo. A lot of accomplishment in 2022, 2023 is really the year of inflection for us. Soft tissue repair is the foundation of that expansion. We submitted the PMA supplement in December 2022. We expect approval in early June, and we plan on launching in July 2023.

There are significant synergies between burns and soft tissue repair, and it will drive our growth for at least three to five years. We believe this is the inflection point for AVITA Medical in terms of our market opportunity, and I will discuss that here in the next slide. To understand what soft tissue repair really means. There are so many possible applications of skin grafts. The fasciotomy and degloving, that's where the patient receives an injury, disconnecting the vascular flow to the skin. What's required is to excise or for the surgeon to cut away that area of the skin and then create a graft to reconnect. Necrotizing skin infection, and that usually requires the surgeon to cut away both tissue and muscle away from the patient because the infection is spreading so rapidly. That's the commonly known as flesh-eating bacteria.

As you can see, as we move down the levels of different things that might happen in the case of a soft tissue repair, there are so many applications. They exist in level one and level two trauma centers. I'd like to spend a minute here talking about the synergy that will occur with soft tissue and burns when we launch in July of this year. To the left, you can see our current market focus. We've had our sales force completely targeted on the approximately 150 burn centers, which has 25,000 of the 35,000 RECELL-eligible patients in them. It's about 300 surgeons. It is where we have built our $34 million in revenue in 2022. It's very important to note we're adding very few accounts right now.

What we see, Q3, Q4, and with our guidance, which we'll discuss near the end of this, my formal presentation, that we're not seeing a lot of new accounts, yet we are seeing an increase in adoption. That increased adoption is very interesting. For example, when we initially launch RECELL, we go after very high Total Body Surface Area burns, 50% or greater. That would use multiple RECELL kits per patient. As you move down to 40% or 30% or 20% or 10% Total Body Surface Area, the consequence is less RECELL kits per patient. We have a rather interesting phenomena occurring.

That phenomena is sales are going up, more patients are getting treated, and the ratio of kits per patient is going down. What that means very logically and clearly is we're moving down from 50% Total Body Surface Area to 30 to 20 to 10. This is decidedly a strong indication of broader adoption. We're really excited about that. Let's talk about the combination of what happens in soft tissue market. Big picture, there's 110,000 or more targeted acute wound procedures that are eligible for RECELL. Take that market size, and now we're going to find the rest of the burn market. Those 10,000 targeted burn procedures exist in level one trauma centers. Why are they there? They're there because they're under 30% Total Body Surface Area.

If you're over, you are required just to be treated in a burn center. These are all under 30. Let's talk about our market opportunity. 25,000, 110,000 plus 10. That is 145,000 plus procedures. We are going to a place easily 4x, 5x, 6x our current market opportunity. At the same time, we're going to go from 300 surgeons to 2,000, from 150 centers to well, more than 1,000. This is going to be an opportunity that really transforms AVITA. A lot of these elements I just explained to you, I'm not going to spend a lot of time on this slide because it's easier to receive it in the manner in which you're looking at the diagram. The commercial launch and synergies are tremendous.

There's one that I didn't mention yet, which is, and I'm going to go back to it, is reimbursement. We have reimbursement in burns in the hospital. We have it in burns for RECELL use in the outpatient setting. When we get approval for soft tissue repair, it uses the same reimbursement codes. Instantly on July first, or probably a little earlier, we will get approval and have instant reimbursement, inpatient and outpatient for soft tissue repair. This is a very uncommon occurrence to have a novel technology that's been well demonstrated, as we have in burns, get a massive indication expansion and have reimbursement. The company has the capital resources to execute and go after that market. That is very uncommon in medtech. Especially on the level of innovation that RECELL brings. Let me spend a minute on vitiligo.

Vitiligo is a breakthrough treatment. The primary e-endpoint is something that it's a comparative study where we treat the patient, the same patient with the control and with RECELL. What you can see side by side is the, what I would call the responder rate. The responder rate is number of patients that actually achieve pigment treatment, pigment transplantation. You can see it on the slide here. At six months, the responder rate for vitiligo was over 80% of patients demonstrated pigment replantation. The control achieved zero. This is a true breakthrough. That said, we are not reliant on the revenue from vitiligo over the next two to three years. One of the reasons is we must apply for and achieve reimbursement for RECELL in the setting of the physician office. We're underway in doing so.

In the meantime, we'll have some cash pay use for RECELL for vitiligo. We are going to do some additional physician-sponsored studies to build podium presence and basically prepare for that bigger launch we anticipate in January 25. This is the big enabler for both burns, soft tissue, and vitiligo. This is the automated device that we call it now, which is a very unexciting name because it's not going to be the marketing name of it, of course. Simply, that manual disaggregation that the physician and the staff need to manage when they take the autologous sample takes time, takes training from our sales and clinical team. As well, it takes time for the hospital physician and operating room staff. There's turnover, of course.

This consumes a significant amount of our sales force time and the staff of the hospital and the physician. It is a inhibitor of adoption. This device, which looks like a desktop blender, in fact, has a very simple mechanism. There's a cassette that goes in it. What the physician does is takes the autologous sample just like they normally do, they put it in the cassette, they put it in the auto device. They press that green button, go. 33 minutes later, it's ready to be loaded into our spray applicator. This takes that training burden down, we estimate greater than 70%. What does it mean? It means that our sales force productivity goes up. In the future, it'll means we need to invest less in additional sales organization as we grow.

We'll still invest in expansion, but not as much as we would otherwise. It means hospitals and their staff do not need near the level of training that is required today. One of our goals was to define, this is a number we, you know, a date we've guided to during last week's call. We plan a submission. It's a FDA supplement submission by June 30th of this year. We expect a 180-day review time. January 1, 2024, we believe we'll be ready to launch. We are in the process of building component inventory for building those devices for that launch. We're in the process of final testing for that submission, this is perhaps the biggest accelerator other than indication expansion that one could imagine for the business of AVITA.

You can see, this is a real year of inflection. Soft tissue repair, vitiligo, we have a 5x market opportunity. We have the automated device. Ahead of us, we have vitiligo to add on top and international expansion to add on top. If you think about that, we have the revenue generators within our control. We're executing on them. In fact, if we didn't spend money on a new channel to build for vitiligo, and we didn't expand international, soft tissue repair and burns would fuel our growth well beyond 2025. We estimate that in early 2025, we would cross over cash flow break even and still have $30+ million.

With the foundation of RECELL, the expansion of indications, the automated device, adding vitiligo and international ahead of us, we have a really strong future ahead of us. Let's look at the year in review for a moment. You can see year-over-year commercial sales, $34 million over $25 million. A very strong performance, but We expect this to be the lowest growth rate that we will see for years to come. Hmm. I mean, it's just a slide lock here. We changed our guidance process, where in prior years, we would give annual guidance. We've decided that we're going to give annual guidance and quarterly guidance every quarter.

The benefits of this is that we will be able to give you, as shareholders and investors, a clearer understanding of how we're doing in the current quarter and how that translate into the broader year. We released guidance last week of $10 million-$11 million, in the range between there, is our expectation for Q1. Remembering that that's all burn revenue, and you can note that this reflects my earlier comments about the increase in adoption, Q3, Q4 into Q1. We're also providing guidance for the year between $49 million and $51 million. At the midpoint of guidance, that would be a 47% increase in revenue over prior year. Some future milestones, which I've discussed during this call, but constitute guidance, is the expansion of our US field sales organization during Q2 from 30 to 70 sales professionals.

We intend to have them fully trained and ready prior to launch and go into launch fully prepared to execute. We expect the approval for the PMA to occur for soft tissue repair to occur in June and the commercial launch on July 1. Vitiligo, we expect that approval in June as well. We will proceed with the strategy I described earlier. The FDA submission of automation on June 30th. One of the purposes of expressing these milestones and this guidance is our commitment to transparency and to help you see what we're doing and how we're doing and how we plan to execute our plan. These are milestones that we feel very strong about. We know they're important and necessary for the business. Their timing has big effect on the performance of the business, and they enable the business.

In summary, our core burn centers will continue to get penetrated. The burns utilization will continue to expand. We're in fact, going to get a 30% market expansion just by being able to have the sales organization that can go to where those 30% are, which is level 1 and 2 trauma centers. We have strong healthcare economics that drive that inpatient adoption. The pass-through code reimbursement for outpatient broadens the opportunity and is applicable to soft tissue. We're about to expand the market for RECELL by 5x. Reimbursement day 1 for soft tissue repair. Remarkably, vitiligo is 5x that in opportunity.

It is truly a huge opportunity that taking the time to prepare and get the reimbursement in place is the most effective and efficient way to build that market in an appropriate investment manner. That reimbursement side of service that we're pursuing, we expect for January 25. That's the timing we'll really start seeing vitiligo energy. At the same time, in the meantime, we're going to be growing at greater than 50% year-over-year. The outlook for the next three to five years in the United States, burns and soft tissue repair drive the revenue for that full five year period. Vitiligo is on top, international is on top. Really a lot of opportunity.

Rudi Michelson
Founder, Monsoon Communications

Thank you, Jim. We'll now move on to the Q&A. If you have any questions, you can continue to submit them using the Q&A function. I'll now hand over to Sean to run the Q&A.

Sean Ekins
CFO, AVITA Medical

Hi, Jim. We have our first question in, can you give us some timing on cash flow positive for timing?

Jim Corbett
CEO, AVITA Medical

I can give you a way to think about it because it really depends on some strategic decisions we make later. Let me outline that sort of framework. If we do nothing with vitiligo and international, we'll cross over cash flow breakeven in the first quarter of 2025. When we do that, we'll still have $30+ million of revenue. I mean, excuse me, of cash. That is one way to look at it. That said, we certainly are going to try to develop the right strategy for vitiligo, and we're going to do more than try. We're going to do it. We'll be coming forward with some view on how we want to do that. The same is true for international.

Let's imagine for the moment the markets are chaotic for whatever reason, and we decide we want to preserve our cash. We would be able to easily do that. We would delay vitiligo and international, perhaps, because we would be in cash accumulation mode through 25. Absent the vitiligo and international investments, we don't see a need to raise cash. I don't think that's a likely scenario for us during the next couple of years, except oriented towards those two possible investments.

Sean Ekins
CFO, AVITA Medical

We have our next question in. Given the sizable increase for vitiligo indication would provide to the potential customer base, would you consider US partnering or is it too early to give any guidance on this?

Jim Corbett
CEO, AVITA Medical

Yes, it's a really good question because it's unquestionable. The incidence of vitiligo is huge. 1% of the population has it. Simply, if we use US market where we're seeking approval at the moment, that's 4 million people. We know from our research into the claims data that last year, 438,000 people with vitiligo sought treatment with the current standard of care, which we know from our own clinical research really doesn't work in very effectively. The opportunity for vitiligo is very huge, but it also is not something that you could do basically a little bit at a time. Partnering is conceptually on the table and doing it ourselves is on the table. We're evaluating what we think will be most effective in terms of bringing vitiligo treatment to patients who are suffering from that condition.

RECELL is the treatment for them. It's early to know. It's a very reasonable thought, Tom.

Sean Ekins
CFO, AVITA Medical

We have our next question in. In regards to the RECELL package sold to customers, is there a number of times the RECELL product can be used, for example, one per patient, or is it just one and done?

Jim Corbett
CEO, AVITA Medical

It's really a one use and disposable. You can't reuse it. In fact, the way the automation will work is we'll have different configurations, for example, for soft tissue repair and burns and a different cassette that will be used for vitiligo. They're both disposable. Incidentally, one of the intended benefits of our design is we're reducing our package size by approximately 70% from the current ease of use device. We're going to use tremendously less packaging product, and we're using components that are reusable, reprocessors from an environmental point of view. It's really a really an advancement in how we're thinking about product development, how we're thinking about our product, and how we really want to contribute to our goal of improving our environmental footprint.

Sean Ekins
CFO, AVITA Medical

We have our next question. It's actually two questions. The RECELL GO may be approved in January 2024. How long after approval do you anticipate being able to commercialize the RECELL GO? Will the new RECELL GO have a higher margin, or will it contribute purely from increasing adoption and sales?

Jim Corbett
CEO, AVITA Medical

First of all, our intention is to be ready on the day of approval with inventory ready to launch. That's our plan, and that's the plan we're working towards. Obviously, we have not built that inventory yet. We've not achieved approval yet. Those are steps along the way, but our intention is to be fully ready for launch on the day of. That's the first question. The second question is, unquestionably, it's going to improve adoption without exception. There is just no doubt about it. It's going to improve the productivity of our own organization and our customer's organization. They won't have to spend so much time training, neither will we. That benefits the parties tremendously. With respect to the margin, we haven't expressed how we're going to deliver it.

There's a lot of different ways we may deliver this device in its availability to the customer. Theoretically, they include a lease, a purchase, or a cost per use or something like that. Those are a range of ideas. One thing is it's obviously not free. I can keep it simple. What we know is we don't intend free, and what we know is the benefits are going to be extremely high for both ourselves and our customer.

Sean Ekins
CFO, AVITA Medical

Our next question is in regards to COSMOTEC, and just asking if you can expand on what is our anticipation for Japan revenues, next year and label expansion?

Jim Corbett
CEO, AVITA Medical

First of all, our relationship with in terms of its commercial performance, is off to a very positive start. We had a stocking order in September of about $555,000. In the Q4, I think we sold somewhere in the order of $200,000-$250,000 to them. We do have expectations that they will continue to expand. They've done hundreds of cases. They're all burn cases. The indication they have is burns. They have not yet applied for soft tissue repair indication nor vitiligo, and we don't have a schedule for that yet. However, I intend to have one soon. I'm working with COSMOTEC directly myself in order to achieve that mutual committed goal.

The COSMOTEC relationship is, you know, up until now, it was purely a regulatory relationship. We were providing them information and data, and they were using it for interacting with their regulatory body, the PMDA, and that's been going on for a few years. We're moving into a new relationship time where we're going to be interacting on a business level, and then our relationship will inevitably develop a new dynamic, and I think both parties are really looking forward to that. I'll have more about COSMOTEC in coming calls. I believe next quarter I intend to be in a position to provide better color about that. In the meantime, they're continuing to use. Their experience has been very positive, so we're quite optimistic.

That said, it's a burns indication only in 2023 and likely 2024.

Sean Ekins
CFO, AVITA Medical

Our next question is, has there been any negative feedback from surgeons on how long it takes to process a graft into spray?

Jim Corbett
CEO, AVITA Medical

There's been feedback about how long it takes to process a graft to spray by physicians. Absolutely, there has been. Some of them, it is a deterrent to utilization on as many cases as they might do as otherwise. When they have, for example, a very high TBSA, using RECELL is the best choice for the patient, and there's no doubt about it. Some of the smaller burns, they may want to just more quickly do an alternative straight skin graft procedure. They might. That isn't as convenient for them. To say they complain about it's rather indirect feedback because what happens is those who are using it regularly get comfortable with the procedure and start utilizing it more, undoubtedly, but they're overcoming doing the extra work. New users have to go through that process.

When we have automation, that whole sequence goes away. In a sense, without a complaint per se, we are observing our customer, and we're using that observation just to make that use of our product simpler and easier so that they can treat more patients. That's our goal because when we treat more patients, everybody wins.

Sean Ekins
CFO, AVITA Medical

Our next question is, are there any plans on getting into the chronic wound space?

Jim Corbett
CEO, AVITA Medical

There's not overt plans right now to get into chronic wounds, and I believe the question is targeted at venous ulcers and diabetic foot ulcers. Both of those are, you know, undertreated medical problems. We have done some prior research in both of those areas. We have indications that RECELL would be applicable from those studies, but they haven't been done in a way that we would use that data for an FDA submission. We are evaluating how we might develop the clinical proof necessary to pursue those market opportunities. As you may know, just in venous ulcers, 1 million patients a year have a constant open wound on their lower inner leg, and closing that would provide an enormous benefit.

We see the potential for RECELL there, we have to demonstrate that it has a good application. One of the difficult parts about that is, by definition, in both cases, they have poor vascular flow. That's one of the issues we're trying to understand in terms of how RECELL will perform in a under, you know, a lower perfused state.

Sean Ekins
CFO, AVITA Medical

Our next question is in regards to if you can give us an update on the Gates Center partnership and in general, the status of the cosmetic genetic fixed POS solutions?

Jim Corbett
CEO, AVITA Medical

The work in Houston Methodist at the Gates Center was a feasibility study, and it reached a conclusion that gave us some encouragement to think about what we might be able to do with genetic modification that would be of the cells that would be delivered through RECELL. What we were able to demonstrate is that in animals, of course, is that the telomeres, which of course are one of the key elements of skin regeneration. They are very long when you're a baby, and the older you get, they get shorter. When you cause that mutation to occur, so to speak, it's not a mutation technically, but when you cause that modification to occur, we've been able to demonstrate the lengthening of telomeres.

This is really encouraging, and it had been originally thought of as a cosmetic-type application. That's of course, a really big idea. Looking closer at the data, what we see is more rapid healing as one of the most compelling, very near-term, achievable, potentially benefits. Our current activity is we're examining how we might develop the animal model that could demonstrate that improved healing. We're working on that right now, and there'll be some update about that in the future. It'll take at least a couple of quarters to come to that conclusion. If we're able to demonstrate that improved healing, which is what we believe, we would develop a study for FDA that would allow us to make that claim. Improved healing is one of the most.

You know, it's the holy grail, so to speak, of wound care. We're thinking about that research a bit differently than it had been when it was originated. That's the update for the moment.

Sean Ekins
CFO, AVITA Medical

Okay. Thank you. The next question is, do you intend to publicly release the 52-week results for the soft tissue in the vitiligo clinical trials once you have the data?

Jim Corbett
CEO, AVITA Medical

We do. They may get released through a publication. That might be really the most appropriate way for them to get released. Right at the moment, in the midst of our FDA submission period, that's considered not the appropriate thing to do. That's the only reason we haven't. The results, of course, as we expressed on the top line, we're comfortable doing that. We exceeded in a favorable way the primary endpoints of both studies. We're feeling very positive about when that ultimately gets. We want it published and we want it released because we get to use it to share with our surgeon customers.

Sean Ekins
CFO, AVITA Medical

Our next question is, will we need any additional clinical information for the automated device ?

Jim Corbett
CEO, AVITA Medical

Right at the moment, what we believe we need to prove is that what we produce for these, the buffered enzyme solution is equivalent when we automate it to when we do it manually. We believe that the way we've developed that research and that testing, that will be what's required by the FDA. At this moment, that's our operating assumption and how we're proceeding.

Sean Ekins
CFO, AVITA Medical

The next question is, can you explain how the automated device improves productivity in the terms of the current device versus what process is actually removed in relation to disaggregation of cells?

Jim Corbett
CEO, AVITA Medical

Disaggregation of cells is the principal work. Otherwise, they take the sample the same, the autologous sample, and presently, they take that autologous sample, and they scrape away and disaggregate it manually. That is the work, and that work goes away completely. They'll take the sample, they'll put it in a cassette. Literally, it's a one-step method. They snap the cassette in the machine, close the door, and press go. It just doesn't get simpler than that. That part which the disaggregation with a person takes quite a while. The cost that the work a person does is putting it in a cassette and pressing go. It's such a monumental difference in the workflow that it'll really, we believe, really affect adoption in a favorable way.

Sean Ekins
CFO, AVITA Medical

Okay. Our next question is in regards to patents and intellectual property. What concerns exist over patent expirations, particularly as it pertains to some competitor offering identical generic version that might allow them to bypass FDA trials?

Jim Corbett
CEO, AVITA Medical

That's a bit of a compound question, so let me try and separate it. We have patents that will expire actually next year. We have other patents that endure for quite a number of years. Part of our intellectual property portfolio falls in the trade secret category, which does not have the expiration that patents do. The automated device , as an example, will create a patent ring that someone else would have to solve if they tried to copy RECELL and were successful doing so. That, that becomes a whole new patent generation for AVITA purely through the use of the automated device . Secondly, the trade secret protections which we currently enjoy have an indefinite life, virtually. Third, I.

Current regulatory framework, I cannot imagine someone being able to copy it without going through their own PMA submission process, clinical study and research. No one that we know of has filed for such a application, so that means they're a few years behind nonetheless. By the time that would happen, if it happened tomorrow, if it did, they're, they would be competing against our automated device . We have a quite a horizon of protection.

Sean Ekins
CFO, AVITA Medical

The next question is in regards to our path to profitability for AVITA Medical. Can you provide any insight?

Jim Corbett
CEO, AVITA Medical

Well, sure. I mean, I did provide some guidance in my earlier comments, and I'll just kind of go through them again. Very simply, our growth trajectory for soft tissue and burns will last us a good five years and would, could just grow the company into profitability on its own. The way I characterized it is that, in fact, that is so strong for us that if we didn't do vitiligo and we didn't do international expansion, Q1 2025 we'd cross over cash flow, break even, and start accumulating cash and still have over $30 million of our present $85+ million. With that thought, that gives you a view of how to think about profitability for the company. We could get profitable. We would be deciding potentially to forgo some things.

So that's a good way to think about where we are as a company. We've got a profitable business model. We have a 83% gross profit. It's a, it's very sustainable in that form. It doesn't have significant price competition. We've in fact had some manufacturing improvements that have occurred in the last quarter that lower our cost to deliver. For example, we used to have to have a what's called cold chain shipping, where we control the temperature of the device, and it was very bulky packaging and very costly to do. We've been able to demonstrate stability of the enzyme through the range of temperatures that the package might experience during the course of its shipping from our facility to the hospital, and the FDA has dropped that requirement.

That took us some meaningful cost out of our process. We have a very strong business model ahead of us, where we want to invest in the growth and adoption of RECELL. We know that that will create a sustainable cash-generating enterprise. Along the way, we have so many opportunities, we're going to have to be sure we choose the right ones and invest our capital carefully and appropriately.

Sean Ekins
CFO, AVITA Medical

Perfect. Looks like I've got two more questions. Just as a reminder, you can submit your questions down below. The last two questions I have is, what have you learned in commercializing RECELL in burns that you hope to apply in soft tissue launch?

Jim Corbett
CEO, AVITA Medical

What we learned from burns that we hope to apply in soft tissues is the question?

Sean Ekins
CFO, AVITA Medical

Correct.

Jim Corbett
CEO, AVITA Medical

Yes. Well, I think most of all, the fundamental focus is on the patient. We've learned that. When you focus on the patient, you start the sales process not with the product but with the clinical data. When you start with the patient and you go to the clinical data and the clinical outcomes, you know that is where you get the physician on board with attempting to adopt or beginning to adopt RECELL. We've also learned how important healthcare economics are. Using RECELL results in faster healing and earlier exit from the hospital, and that is a real economic benefit to the hospital, and we've learned how to do that, and that will apply across the board as we go into soft tissue. I'd say those are the two big learnings that we think about.

Sean Ekins
CFO, AVITA Medical

Okay. Our last question that we have is in regards to our international plans. Do we have a strategy that would be similar like we did in the US, or would we potentially partner similar like we have in Japan?

Jim Corbett
CEO, AVITA Medical

First of all, we haven't developed a plan for international yet. That's my broad statement, and we plan to have one to communicate by the Q3 call. That said, the idea that we would go like US in every one of the 20, 25 countries that might be candidates for AVITA to go into is not likely. It's very possible we'll have a series of partners and potentially some direct operations. What we're going to try and do is automation opens up the world for us. It allows us to think about things in a different way from the amount of company headcount that we need to dedicate to the globalization of RECELL.

There'll be some combinations, and I promise to have a lot more for you by the Q3 call.

Sean Ekins
CFO, AVITA Medical

Well, perfect. We have no further questions. I'd like to thank everyone on the call today for joining today's presentation. Please feel free to contact us as investor@avitamedical.com. Thank you very much.

Rudi Michelson
Founder, Monsoon Communications

Thank you to everybody. Thank you for joining.

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