AVITA Medical, Inc. (RCEL) Earnings Call Transcript & Summary

Good afternoon to everyone in the U.S., 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 the AVITA's Sydney, Melbourne roadshow this week and follows on from AVITA's strong fourth quarter results last week. [Operator Instructions] Presenting today is AVITA's CEO, Jim Corbett and assisted by CFO, Sean Ekins. I'll now hand over to Jim to begin the presentation.

Welcome, and welcome to actually our second consecutive quarter webinar really, although we have a 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 meetings with investors and analysts. And I thank you for joining. I'd like -- some of you may be joining for the first time. So I'm going to begin with a couple of descriptions of the company. What is -- who is AVITA Medical? We are a regenerative -- tissue regeneration company. And 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 skin graft. We then disaggregate cells, we suspend it in an enzyme solution. We put it in a spray on applicator and we spray on those cells to the wound to -- and it causes -- catalyzes the healing process. The current U.S. indication is acute thermal burns. Now we have 2 PMA supplements pending, which I will be discussing in some detail for soft tissue repair and reconstruction and one -- additionally for the treatment of the autoimmune condition known as vitiligo. Now the advantage is just to keep it very focused why RECELL is better than the alternative. It's very -- kind of 3 steps to think about. First, you take less skins from the donor. The patients like that, not surprising, in fact, they like it a lot, and they prefer it and they want that. The second is really important because it improves healing. So the healing has multiple consequences that are favorable. Healing helps the patient, obviously, get home to their families sooner, helps to leave the hospital sooner, which saves the hospital money under the way reimbursement is structured in the U.S. market where we are currently marketing and it produces less scarring. So it's a really significant advantage in the treatment of patients who need a skin graft. We've been using this on the -- really, frankly, the nastiest type of wound, which is a thermal burn. And we'll talk more about the indication expansions that we're expecting soon during this session. So this describes the methodology that I just outlined for you. And you can see how it works from a process point of view. But it is a manual disaggregation of the cells that go into the kit that you see in item number two. And 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 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. So the use of RECELL goes back to the Bali bombings and the extraordinary recovery of those patients here in Australia. So that's really the foundation. And 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 to soft tissue that PMA supplement was submitted on December 9, and 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. And 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 2 parties are working towards approval. So we have passed that FDA 100-day mark, and we're anticipating the June approval. The vitiligo study which is treating the autoimmune condition where patients lose pigment. And that study was also created -- excuse me, completed last year and submitted December 16. And it's on a similar breakthrough device designation, a separate one, by the way. And we expect that approval in June as well. Now you see out to the right there that there's a comment about reimbursement in office, let's say reference to vitiligo will be used to what we 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, U.S. Time, Friday, Australian, last week. First, revenue, our fourth quarter was 37% over the same quarter of prior year, which was ahead of expectations. We also announced the availability during 2022 of the ease-of-use device. As well during '22, we got -- we received approval for burns treatment of -- 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, but 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 3 to 5 years. So we believe this is the inflection point for AVITA in terms of our market opportunity, and I will discuss that here in the next slide. First, you understand what soft tissue repair really means. There are so many possible applications of skin grafts. The fasciotomy and degloving where the patient receives an injury, disconnecting the vascular flow to the skin. What's then required is to excise -- for the surgeon to cut away that area of the skin and then create a graph to reconnect. There's 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, and they exist in Level 1 and Level 2 trauma centers. I'd like to spend a minute here talking about the synergy that will occur with soft tissue and burns when we launched 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 and it is where we have built our $34 million in revenue in 2022. Now it's very important to note, we're adding very few accounts right now and what we see Q3, Q4 and with our guidance, which we'll discuss near the end of this formal presentation, that we're not seeing a lot of new accounts, yet we are seeing an increase in adoption. And that increased adoption is very interesting. For example, when we initially launched 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 service area, but consequences less RECELL kits per patient. So we have a rather interesting phenomena occurring that a phenomenon 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% to total body surface area to 30% to 30% to 10%. This is decidedly a strong indication of broader adoption. So we're really excited about that. Now 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. Now 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 1 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. Therefore, these are all under 30%. Now let's talk about our market opportunity, 25,000, 110,000 plus 10. So that is 145,000-plus procedures. So we are going to a place easily 4, 5, 6x our current market opportunity. At the same time, we're going to go from 300 surgeons to 2,000, from 150 centers to more than 1,000. So this is going to be an opportunity that really transforms AVITA. A lot of these elements I just explained to you, and I like 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. So the commercial launch and synergies are tremendous. There's one did I -- I didn't mention yet, which is -- and I'm going to go back to it, is reimbursement. We have reimbursement in burns, in hospital, and we have it in burns for RECELL use in the outpatient setting. When we get approval for soft tissue repair uses the same reimbursement codes. So instantly on July 1 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 that we have in burns, get a massive indication expansion and have reimbursement and the company has the capital resources to execute and go after that market. That is very uncommon in medtech and especially on the level of innovation that RECELL brings. Let me spend a minute on vitiligo. Vitiligo is a breakthrough treatment. The primary endpoint is something that -- it's a comparative study where we treat the patient -- the same patient with the control and with RECELL. And what you can see side by side is the what I will call the responder rate. And the responder rate is a number of patients that actually achieved pigment treatment -- pigment transplantation. You can see it on the slide here. At 6 months, the responder rate for vitiligo was over 80% of the patients demonstrated pigment replantation. The control achieved 0. So this is a true breakthrough. That said, we are not reliant on the revenue from vitiligo over the next 2 to 3 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 used 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. But simply, that manual disaggregation that the physician and the staff need to manage when you take the autologous sample, it takes time, it takes training from our sales and clinical team as well, it takes time for the hospital physician and operating room staff. And there's turnover, of course. And so this consumes a significant amount of our sales force time and the staff of the hospital and the physician. So it is an inhibitor of adoption. Now 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, then they put it in the cassette, they put it in the automatic device, press green button, go. 33 minutes later, it's ready to be loaded into our spray applicator. So this takes that training burden down, we estimate greater than 70%. What I mean -- it means that our sales force productivity goes up. In the future, it 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 and this is a number we -- a date we've guided to during last week's call, we plan a submission. It's a FDA supplement submission by June 30 of this year. We expect a 180-day review time and 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. And this is perhaps the biggest accelerator other than indication expansion that one could imagine for the business of AVITA. So 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 and ahead of us, we have vitiligo to add on top and international expansion to add on top. So if you think about that, we have the revenue generators within our control. We're executing on them. And 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, which fuel our growth well beyond 25% and we estimate that in early '25, we would cash -- cross over cash flow breakeven and still have $30-plus million. So with the foundation of RECELL, the expansion of indications, the automated device, adding vitiligo in international ahead of us, we have a really strong future ahead of us. Let's look at the year-end review for a moment. And 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. Let me -- just a slide lock here. So 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 translates into the broader year. So we released guidance last week of $10 million to $11 million in the range between that 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, [ except ] Q1. We also provided 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 U.S. 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 commercial launch on July 1. Vitiligo, we expect that approval in June as well, we will proceed with the strategy, I described earlier and the FDA submission of automation on June 30. One of the purposes of expressing these milestones in 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 a big effect on the performance of the business. and they enable the business. So in summary, our core burn centers will continue to get penetrated. The virtualization will continue to expand or 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 health care economics that drive that inpatient adoption and the pass-through code reimbursement for outpatient broadens the opportunity and is applicable to soft tissue. We're about to expand the market for resell by 5x, reimbursement day 1 for soft tissue repair. Remarkably that vitiligo 5x that opportunity. So 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 matter that reimbursement side of service that we're pursuing, we expect for January 25. So 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. So the outlook for the next 3 to 5 years in the United States, burns and self tissue repair drive the revenue for that full 5-year period. And vitiligo's on top, international's on top. So really a lot of opportunity.

Thank you, Jim. We'll now move on to the Q&A. [Operator Instructions] I'll now hand over to Sean to run the Q&A.

Jim, we have our first question in. Can you give us some timing on the cash flow positive for timing?

I can give you a way to think about it. because it really depends on some strategic decisions we make later, but 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 '25. When we do that, we'll still have $30-plus 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. And we'll be coming forward with some view on how we want to do that. The same is true for international. But 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 in international perhaps because we would be in cash accumulation mode through '25. So absent vitiligo and international investments, we don't see a need to raise cash. So I don't think that's a likely scenario for us during the next couple of years except oriented towards those 2 possible investments.

We have our next question in. Given the sizable increase for vitiligo indication would provide to the potential customers, will you consider a U.S. partner? Or is it too early to give any guidance on this?

A good question because it's unquestionable the incidence of vitiligo is huge. 1% of the population has it. So simply, if we use U.S. market where we're seeking approval at the moment that's 4 million people. We know from our research into the claims data, the last year, 438,000 people with vitiligo stop treatment with the current standard of care, which we know from our own clinical research really doesn't work very effectively. So the opportunity for vitiligo was very huge, but it also is not something that you could do basically a little bit at a time. So 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. And RECELL is a treatment for them. So it's early to know. It's a very reasonable thought.

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

It's really a one use and disposable you can't reuse it. In fact, the way the automation will work as well have different configurations, for example, for soft tissue repair and burns and a different cassette that will be used for vitiligo but they're both disposable. And incidentally, one of the intended benefits of our design is we're reducing our package size by approximately 7% from the current ease-of-use device. So we're going to use tremendously less packaging product. And we're using components that are reusable reprocessable from an environmental point of view. So it's 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.

Our next question is actually question [indiscernible] automated device may be approved in June year 2021. How long after approval do you anticipate commercialize the automated device? And will the new automated device had a higher margin? Or will it contribute from increasing adoption in sales?

First of all, our intention is to be ready on the day of approval with inventory ready to launch. So that's our plan. And as 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 a launch on the day of. That's the first question. The second question is, unquestionably, it's going to improve an option without exception. There's just no doubt about it. Also it's going to improve the productivity of our own organization and our customers' organization. They won't have to spend so much time training neither will we. That benefits 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 and its availability to the customer. Theoretically, they include a lease, a purchase or cost per use or something like that. There are a range of ideas. One thing is it's obviously not free. So I can keep it simple. What we know is we don't intent trade. And what we know is the benefits are going to be extremely high for both ourselves and our customers.

Our next question is in regards to Cosmotec. And just asking if you can expand on what is our anticipation for planned revenues next year in label expansion?

So first of all, our relationship with Cosmotec is off to -- in terms of its commercial performance is off to a very positive start. We sold about -- which had a stocking order in September of about 555,000. And into the fourth quarter, I think we sold somewhere in the order of 200,000 to 250,000 to them. And we do have expectations that they will continue to expand. And they've done hundreds of cases. They're all burn cases. The indication they have is burns. They have not yet applied for a 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. So the Cosmotec relationship is since -- up until now, it was purely a regulatory relationship. We are providing information and data, and they were using it for interacting with their regulatory body, a 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 our relationship will inevitably develop a new dynamic. And I think both parties are really looking forward to that. So 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. So in the meantime, they're continuing to use, their experience has been very positive. So we're quite optimistic. That said, it's burns indication only in '23 and likely '24.

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

There's been feedback about how long it takes to process the graft to spray by physicians, Absolutely, there has been. And some of them, it is a deterrent to utilization on as many cases as they might do 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. And that isn't as convenient for them. So to say the complaint about it, 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. So 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.

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

It's not over at 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 undertreated medical problems. We have done some prior research in both of those areas. We have indications that RECELL will be applicable from those studies, but they haven't been done in a way that we would use that data for an FDA submission. So 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. So 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. And so that's one of the issues we're trying to understand in terms of how RECELL will perform under a lower perfused state.

Okay. Our next question is in regards to if you can give us an update on the Gates Center partnership and in general, the status the Cosmotec genetic fixed [ possible ] solutions.

So the work and use of methods 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 will be delivered through RECELL. What we were able to demonstrate is that we -- 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. And so when you cause that mutation to occur, so to speak, it's no mutation technically, but when you cause that modification to occur, we've been able to demonstrate the lengthening of telomeres. Now this is really encouraging. And it had been originally sort of as a cosmetic type application. That's of course, a really big idea. But looking closer at the data, what we see is more rapid healing as one of the most compelling, very near-term achievable potentially benefits. So 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 will 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 because improved healing is one of the most -- it's the Holy Grail, so to speak, of wound care. So what we're thinking about that research a bit differently than it had been when it was originated. But that's the update for a moment.

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

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

Our next question is we need any additional clinical information for the auto device?

Right at the moment, what we believe we need to prove is that the -- 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 conducted -- 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.

I think the next question is, can you explain how the automated device improves productivity in the terms of the current device versus what processes actually moved in relation to disaggregation of sales?

Well, disaggregation of cells is the principal work. Otherwise, they take the same -- the sample the same -- the autologous example. And presently, they take autologous simple and they shake away and disaggregate it manually. That is the work, and that work goes away completely. So they'll take a 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, let's go. So it just doesn't get simpler than that. And in that part, which the disaggregation with a person takes quite a while. The process -- the work that a person does is putting it in a cassette and pressing go. So it's such a monumental difference in workflow that will really, we believe, really affect adoption in a favorable way.

Okay. Our next question is you were the patents intellectual property. What concern exists over patent expirations, particularly as a pertains to some competitor offering identical generic version that might allow them to bypass FDA trials.

That's a bit of a compound question. So let me try and separate it. So we have patents that will expire actually next year. We have other patents that endure for quite a number of years. As part of our intellectual property portfolio falls in the trade secret category, which does not have the expiration of patents. So the automated device, as an example, will create a patent ring that someone else would have to solve if they try to copy RECELL more successful doing so. So 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. And third, our current regulatory framework, I cannot imagine someone being able to copy it without going through their own PMA submission process, clinical study and research. And no one that we know of has filed for such an application. So that means they are a few years behind nonetheless. And by the time that would happen, if it happened tomorrow, if it did, there -- they would be competing against our automated device. So it's -- we have a quite a horizon of protection.

The next question is in regards to our path of profitability for -- if you provide any insight?

Well, sure. I mean I did provide some guidance in my earlier comments, and I'll just kind of go to them again. Very simply, our growth trajectory for soft tissue and burns will last us a good 5 years. And what could just grow the company into profitability on itself. The way I characterize 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 '25, we cross over cash flow breakeven, start accumulating cash and still have over $30 million of our present $85-plus million. So with that thought, that gives you a view of how to think about profitability for the company. We could get profitable, but we would be deciding potentially to forego 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 an 83% gross profit. 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 what's called cold chain shipping where we control the temperature of the device. And it was very bulky packaging, very costly too. 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. So that took some meaningful cost out of our process. So we have a very strong business model ahead of us. We want to invest in the growth and adoption of RECELL. We know the 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.

I've got 2 more questions. [Operator Instructions] The last 2 questions I have is, what have you learned virtualizing RECELL in burns that you hope to apply in soft tissue launch?

What we learned from burns that we hope to apply a soft tissue is the question.

Correct. Yes.

Well, I think most of all, the fundamental focus is on the patient. We've learned that. And 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, when 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 health care economics are. Using RECELL results in faster healing and earlier exit in 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. So I'd say those are the 2 big learnings that we think about.

Okay. One last question that we have is in regards to our international plans. Do we have a strategy that would be similar like in the U.S.? Or would we potentially partner some of like you have in Japan?

Well, first of all, we haven't developed a plan for international yet. So 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 U.S. 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. And so what we're going to try and do is automating 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. So there'll be some combinations, and I promise to have very -- a lot more for you by the third quarter call.

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 [email protected]. Thank you very much.

Thank you to everybody. Thank you for joining.