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

March 24, 2022

NASDAQ US Health Care Biotechnology special 58 min

Earnings Call Speaker Segments

Michael Perry

executive
#1

Good morning. Hi, I'm Dr. Michael Perry. I have with me Michael Holder, our CFO. I'm CEO of AVITA Medical, and I would like to take you through an abridged version of our corporate presentation, and then we'll open it up for Q&A. Thanks for joining. This slide is a legal disclaimer as we're traded both in the U.S. on the NASDAQ and here in Australia on the ASX. If you direct your attention to the right-hand side of this slide, what you see is a human figure -- sorry, to the left-hand side, what you see is a human figure with a yellow ball, which is meant to be a patch of healthy skin or a small biopsy that's taken from the patient. Then going counterclockwise, you see the RECELL device, the black well is a well where we put a proprietary enzyme, and the tissue is soaked in there for about 10 minutes, then the white well is full of -- is loaded with buffer, not heated, whereas the black well is heated. And the final well on the right-hand side of the device, showing up, I believe, in green or in yellow, depending upon your computer setting, and that is a 1 micron filter, just a filter on any hair follicles or larger pieces of skin that aren't fully disaggregated cells, so they don't clog up our spray nozzle that we provide. And then, within 25 to 30 minutes at point of care, from taking that initial biopsy going through the system, you've got spray-on skin cells. We are currently approved for burns in the United States. We also have TGA approval as well as EU CE mark and other approvals around the world, but currently, we're marketing only in the U.S. Turning your attention to the right-hand side of the slide. Here, we're showing really that this is a platform technology. We have trials ongoing in vitiligo, in trauma, burns and scalds were already approved, chronic wounds. We have pilot data that are very strong, scar revision, some pilot data, on and on. This is not a comprehensive list. There's a lot more that goes with the RECELL system. Looking at value creation over the last little while, if we look at our key accomplishments on the left-hand side of this slide, you can see that the quarter ending December 31, 2021, had revenue growth of 35% versus the same quarter in 2020. We did get FDA approval of our Ease of Use device, and I'll be talking a little bit more about that, coming up. We -- our partner in Japan, Cosmotec, gained PMDA. That's the Japanese health authority approval of burns in Japan. I'll be talking a little bit about that, additionally. And both our vitiligo pivotal trial, this is a registration trial, as well as our soft-tissue pivotal trial have completed enrollment of their patients. Now, they're following the patients, and I'll speak a little bit about those trials and when we anticipate submitting PMAs, top line data release as well as we anticipate our approval of these two indications. We did get a transitional pass-through payment for the outpatient setting. This is indication agnostic. So it will work that outpatient code that was provided by CMS, will basically cover any indication. It will cover burns, it will cover soft tissue. So we're in a good position there. The TPT, or transitional pass-through payment, is something that's not easy to gain, and we're proud to have it. It is CMS only. So it starts out covering about 15% of patients' lives and so far, is the patient population that might be eligible for outpatient reimbursement. And then we work with the commercial payers. But once you've got the TPT, it really provides an anchor for moving forward with the commercials. In both epidermolysis bullosa and rejuvenation, one being a genetic disease of the skin, EB, where the top layer of skin, the epidermis, is not appropriately anchored to the underlying dermis. And that's due to a single defect, a single-gene defect. And it is specifically collagen 7A1 that normally binds the epidermis to the dermis. And we've established proof of concept there. And in rejuvenation, we've also have initial proof of concept on the delivery of reverse-aged skin cells. And I'll be talking a little bit more about that and showing you some histology relative to how the skin is forming after it's been genetically manipulated. Key milestones ahead. We have top line results for vitiligo as well as vitiligo submission in the second half of this calendar year and vitiligo commercial launch in the second half of next year. Similarly, for the soft tissue or trauma indication, we are looking at similar timelines, top line data and PMA submission in the second half of this calendar year, approval in the second half of '23. This is actually for soft tissue, bringing in of our timeline by approximately 9 months, so ahead of schedule and now, right -- neck and neck with vitiligo. So we're pleased, we had a very nice enrollment curve, when COVID started to let up. Regarding the outpatient launch, I did mention we have the transitional pass-through payment. But another element of that is, I would say, valuable for the launch in outpatient, and in general, is our new Ease of Use device that we are starting to launch now and is -- we're starting it, of course, in our established accounts because it's -- well, we'll ultimately be utilizing this device for all indications, let's just say. And I'll talk a little bit more about its attributes and why it's an ease-of-use device, in an upcoming slide. In the second half of this calendar year, we'll also be looking with the FDA at both the reverse-aging product and the epidermolysis bullosa, the genetic correction, and seeing what, if any, additional preclinical studies will be required before we submit an IND, an investigational new drug application, and go into first in patients relative to our Japan approval. The next step is for our partner there, Cosmotec, to be speaking with the MHLW, Ministry of Health Labor and Welfare, now that they have PMDA approval, and the MHLW will be working with them to establish price for reimbursement. Moving on to our development pipeline. Here, you can see the various indications down the left. And on the top, you can see where the product end is in, in its development cycle. For acute thermal burns, we are approved, and we've been selling for a couple of years. We did start sales in January of 2019, and of course, COVID hit us in 2020, but we've continued to grow. Japanese approval by the PMDA, we just received. So I've mentioned that. And both the vitiligo and soft-tissue trials are ongoing and have completed their enrollment. As I mentioned, in epidermolysis bullosa and in rejuvenation, we've established proof of concept. So we're moving out of discovery into feasibility. And so far as innovation on the device platform, we have the new Ease of Use device, which is recently approved by the FDA, and we are working on design features for the fully-automated device, which we believe will be very important to enable the vitiligo indication. That's going to be a different call point. It will be in the office of interventional dermatologists and plastic surgeon. So for a small company, we're doing a lot, and this should be creating a lot of value over the next 18, 24 months. Here, we see the opportunity for the pipeline. Looking on the left-hand side of the slide, you see approximately $6.8 billion of opportunity. This is highly derisked. We're already approved in the U.S. in burns. We have the soft-tissue indication coming up. And that -- when approved in the second half of 2023 that we're predicting, that's almost twice the size of the burns indication. It's a $1 billion addressable market. And if we look at vitiligo in the blue, we see that, that's a multiple of the soft tissue, $5.2 billion addressable market, total addressable market in the U.S. These are just for the U.S. So those add up to $6.8 billion and are highly derisked because we've already utilized the RECELL device in a lot of patients. And I'll speak to that in a number of publications we have already, as well as the number of patients who have been treated. So very low risk. Higher risk but not extraordinarily high, regular risk and not de-risk, it is our cell-based gene therapy programs. Rejuvenation that I just mentioned, where reverse aging the skin biologically using RNA telomerase, that's a $15 billion market in the U.S. alone. And epidermolysis bullosa, which is just one of approximately 50 genodermatosis or genetic diseases of the skin. And just that one indication. Right now, there are no treatments available, other than symptomatic treatment support dressing. I'll be talking about that a little bit, but that would be an $800 million opportunity in the U.S. alone. Combined over $22 billion of total market opportunity here. As I mentioned, the part on the left-hand side of the prior slide is highly derisked. Here you see acute wounds, including burns. You see vitiligo and chronic wounds, which we're currently not progressing because we can't do everything at the same time, and we don't want to burn through all of our cash quickly. But you can see the number of patients as well as the number of presentations and publications in each of these indications. So very highly derisked. The product has been -- has already shown efficacy in these indications, has been used many times. And overall, when we look at -- since the company was launched since the days of Fiona Wood in 2002, over 15,000 patients have been treated utilizing the RECELL device. Talking a little bit about that C Code for the outpatient sector. That became effective January 1 of this calendar year. The code is C1832. And you can read the indication there. It basically reimburses for the cost of the device or ASP. And the code is generally utilized for 2 to 3 years and then converted to a permanent code. Again, Medicare covers approximately 15% of patients' lives. So we'll be working with the commercial payers to enable a very broad reimbursement for the outpatient opportunity. Again, it's indication agnostic. So it applies equally to burns and soft-tissue wounds. Here, as I mentioned, the new Ease of Use device, it has a reduced number of steps, that the number of steps required from taking the biopsy to having the spray-on skin cells has been reduced by 30%. The process is easier. And so far, it does not require second pair of hands outside of the sterile field. Previously, the packaging had it so that there had to be a nurse or another attendant outside of the sterile field, opening a variety of packages for scalpels, for syringes, for various elements of the RECELL system. Now, it's basically you take the plastic box that has all of the components sterilized in it, take it out of the cardboard box, put it into the sterile field and you're ready to go. There's no passing of continuous elements of the system. And improved usability of the physicians that we surveyed, 94% of the users said they believe it will reduce their workload and allow them additional time to perform other surgeries or other duties that they have. So we're very excited about this next generation of machine, and we have a further one that's in development, completely automated, that's going to be used in the dermatologist office. That's in design phase and now moving into the development. Here, we see the vitiligo's study enrollment. You can see the step-up that happened in '21 and last year, really. And enrollment is complete now. As I mentioned on the second slide, beforehand, we anticipate FDA submission of the PMA in the second half of this calendar year. Here on the right-hand side, we just have a picture from a prior study, where you can see a negative control and you can see a RECELL-treated patch, and there's a full return of pigmentation there. And this has been for stable vitiligo. Vitiligo is an autoimmune disease, where the patient's own immune system attacks its melanocytes, and they do -- they stop producing the pigment. And this [Technical Difficulty] compared to, for example, excimer laser that recently received reimbursement from Cigna, that was at a rate of $30,000, approximately, per year, the reimbursement for the laser. And that's a continuous therapy that's required, and it requires like twice a week to be in the dermatologist office, whereas this is a one-and-done, as far as we know. It is durable. Early completion of our soft-tissue reconstruction or trauma trial. Here, you can see COVID impact. It was 1 or 2 patients, maybe 6, but low to mid-single digits. And then, as we started to emerge from COVID in the second half of last calendar year 2021, we were able to enroll all of the patients ahead of schedule. And again, FDA submission of a PMA for this indication is expected in the second half of this calendar year, with approval in the second half of next calendar year. On the right-hand side, you can see a patient, this is actually necrotizing fasciitis, and the patient, very, very deeply, needed to be dissected. By the way, a necrotizing fasciitis, for those of you who are not aware of that, that's basically the flesh-eating bacteria. And the patient had to have the skin deeply resected from the axillary area, the armpit, all the way to hip. And 1 year post treatment -- although it may not look great to you and I don't have a control, but this is a wonderful outcome, compared to current standard of care. So just showing what RECELL can do in in-stock tissue reconstruction. By and large, though, the wounds in soft tissue are small, unlike burns that come in very large sizes, high total body surface area. Generally, the preponderance of soft tissue wounds are small, small meaning they would only require one RECELL kit. And a little bit more about it, relative to the commercial launch of the soft tissue indication. Currently, there are 136 or so [indiscernible] burn centers in the United States. And they're our current target, where we are currently selling the RECELL system. About 50% of these burn centers are co-located with Level-1, Level-2 trauma centers. So there's a good number of our physicians who have already been trained, who will be utilized in the RECELL system and are already trained on it, from the burns, some or few are actually utilizing it off label. We can't promote it, of course, for soft tissue until we have the indication. That said, we're going to go to an additional 230 high-volume trauma centers, once we get the approval, and reimbursement is in place. The CPT codes will be the same. The outpatient C Code will be the same. It's the same treatment protocol, stabilize the patient, debride the wound, clean the wound, and then is the patient requiring a skin graft. And if so, let's use RECELL. And it's the same unmet medical need as burns, relative to reduction of donor area. So the likelihood of this trial coming out positive is very high. And it's a very large opportunity, and it really leverages our current infrastructure, commercial and sales infrastructure, relative to burns. Talking a little bit about our cell and gene therapy programs. If you look on the left-hand side of this slide, that's the patient that figure that I started out with, when I described the basic use of the RECELL system to repair defects such as burns or soft-tissue wounds. Our future platform on the right-hand side of the slide, you can see the only real difference is in this greenish colored box, where after disaggregation and before spraying on, these skin cells are genetically modified either genetically corrected for EB, single mutation on collagen 7A1 or adding RNA telomerase. We're doing the EB program epidermolysis bullosa, with the Gates Center for Regenerative Medicine at the University of Colorado, in Denver. And we're working on the rejuvenation program with the Houston Methodist Research Institute. And we have a right to acquire the intellectual property, globally, for these two indications, should they pan out to be effective. So next steps for the cell and gene therapies, we've established proof of concept for both in immunocompromised rodent model. Next, we'll be looking at that, perfecting those data and then interacting with the FDA [indiscernible], which IND-enabling studies, investigational new drug application, what IND stands for. So which preclinical studies, which additional animal studies might be required before we go into first in human. So as I said now, we're optimizing, when we're going to be meeting with the FDA. Here, you see the epidermolysis bullosa that [ single ] gene mutation, which is a very serious disease, albeit an orphan disease. In its worst form, recessive dystrophic epidermolysis bullosa, or RDEB, what we're showing here in the left-hand side of the slide in the figure is keratinocytes and fibroblast. And these can be corrected by gene-editing technologies that are currently available, put into an immunocompromised [Technical Difficulty] we show that, and we can grow normal skin. And on a histology, we can see that the epidermal layer is bound appropriately to the dermal layer. So we have [indiscernible] with utilizing the spray-on system as opposed to growing sheets of corrected cells, which a couple of other companies are doing. The sheets are very difficult to maneuver with and also, the sheets of corrected cells end up being a patch work because they need to be individually stapled or sutured onto the patient, whereas the spray will adhere to areas that do not have epidermis. Here, you can see not a recessive dystrophic but heterogeneous form of epidermolysis bullosa. Skin fragility is the real issue. When these individuals are even just putting on clothing, their epidemics will just slip off. And here, you can see multiple scarring in between the raw areas. The cost burden for these patients, just to manage them, not to correct their disease, is about $200,000 to $500,000 a year. And what we're offering is the opportunity for imperative, efficient and convenient suspension opportunity with genetically-corrected cells, where we've proven the concept, so far. In the -- so far as the reversed [ aging ], Again, we've utilized the RECELL system to disaggregate the cells. And at the point of care, we can introduce mRNA telomerase or hTERT, that's human telomerase reverse transcriptase. And that not only lengthens the telomere, but it also provides nuclear changes, where the cell is -- the skin cells are acting as though they're very young skin cells, 5, 6 years of age. If you look at the bottom right in the black little square, what you see there is immunohistochemistry. And those pink dots along the top surface there of the skin would -- it's showing production of collagen and elastin, which aged cells people, say, over 50, certainly over 55 years of age. Those cells are not going to be producing collagen and elastin, if any, at a small rate. And we're quite hopeful for this as a rejuvenation indication, although initially, we'll probably follow the route of Botox, where they went for a real indication, i.e., there was a risk benefit as opposed to a rejuvenation, where there's really no risk -- risk of getting wrinkles and some aging spots. Talking a little bit about corporate financial overview. You can see year-over-year since we gained approval in September of 2018, 2019, 2021, you can see how our commercial sales have ramped. We've provided guidance for calendar year 2022 of $30 million. We're still seeing some pressure due to the nurse shortage. So we're having to do a lot of trainings. Last quarter, we did about [Technical Difficulty] trainings [Technical Difficulty] to be [indiscernible], and we exited the year with over USD 100 million in cash, and we have no debt on our balance sheet. Of course, our share price is depressed, along with the entire sector, which has gone down substantially in the last month or two. We do have a strong patent estate that protects our technology. And in addition to the PMA, where in order for somebody to come in, they would actually have to run the clinical trials and show that they are having an equal effect as we have and not violating any of our patents in so doing. So 18 granted, and 24 and more are coming. For example, our fully-automated system as well as our Ease of Use system, new patents have been filed. And if issued, and it looks good right now, those will give us a 20-year new life on those patents. Here, you see our leadership team, myself and Michael on the left and the rest. I'm happy to say that we have a very solid, very experienced leadership team, who are really performing well, given the challenges that we have had. And we're looking forward to having more time face-to-face, now that COVID is abating. Risk factors and disclosures, again, as we're publicly traded. Important safety information as we're selling the product in burns, currently in the United States as well as in parts of Australia and basically a revolutionary treatment there. It's been over 50 years since the skin grafting procedure has been changed and 20 years in the United States since a new PMA as opposed to the 510(k), which is basically a copy of the current technology. But a PMA, an original, randomized, controlled clinical trial showing outcomes and showing outcomes that are superior versus the current standard of care, the [ thickness ] autograft. I'll stop on this slide, which recapitulates our key accomplishments and key milestones moving forward, and I'd like to open it for Q&A.

Michael Holder

executive
#2

So Mike, we received a number of questions prior to the call. And I'm going through those. A number of them are sort of repetitive on similar topics, and some of them have been addressed by your presentation. So first question, congratulations on the new agreement with Premier. Can you provide a little color on what this agreement might mean for revenues in 2022 and otherwise thereafter? And does this agreement help you with burns or soft-tissue reconstruction more so?

Michael Perry

executive
#3

Thank you for the question. The Premier agreement is -- Premier is one of the largest [ GPOs ] in the United States. And for them to actually have it accepted in their network of hospitals, really gives us an in to -- for both burns, although they cover only a few burn centers, they do cover a lot of trauma centers. So I think we'll see the real impact, going forward, in soft tissue. Michael, is there anything you would like to add to that?

Michael Holder

executive
#4

No, I think you covered it really well. Just to reiterate, we don't expect a whole lot in 2022, largely because of the burns focus. But in '23 in there and beyond, it should begin to make a material difference. Thank you. Next question has to do with the recent announcement relative to BARDA support of the soft-tissue reconstruction trial. And how much support, financial support? What is the dollar support of BARDA in this agreement? And is there any potential benefit beyond just the soft tissue-based clinical trial?

Michael Perry

executive
#5

So the current clinical trial is fully enrolled and is awaiting the period, a follow-up time, and then top line data will be released, as I mentioned. The BARDA funding, I guess it's important to note that where this came from. And BARDA's remit for the burns division has actually been broadened. So they are responsible for both burns as well as acute traumatic wounds, whether that's falling off a motorcycle, but more likely, in their case, it's shrapnel and those types of acute wound injuries in a mass-casualty situation. So BARDA is going to be helping us. They're not retrospectively going back and funding the trial. But moving forward, for example, if we decide after PMA review, but prior to PMA approval, during those 9 or 10 months, that we want to go forward, for example, with compassionate use or a continued access program and generally to drive awareness and utilization in this syndication, that's where BARDA is supporting us. I don't believe that we've released publicly a dollar amount. So unfortunately, I can't speak to that, right now.

Michael Holder

executive
#6

That's right. We haven't. And we haven't actually received approval from BARDA to announce the funding. So we're actually not allowed to, so... There are a number of questions around operating expenses, cash burn rate. When will you guys reach profitability? And, sort of, what is the thought process and strategy with your current pathway and plans for those expenditures?

Michael Perry

executive
#7

Yes. Let me start, Michael, and then I'll pass it back to you to go into details on the OpEx and our cash burn. Relative to profitability, we've got approximately 50% of our shareholders in Australia here and 50% of our shareholders in the U.S. on NASDAQ. And there's a fundamental difference between the two. Usually, the Australian market is looking for how quickly can a company move into an indication, establish sales in that indication and crossover EBITDA breakeven and go into real profitability. I would say, back of the envelope kind of calculation, we're already there in burns, I would imagine. But we can't actually do that calculation and assign operating expenses, et cetera. Otherwise, that's, in the U.S., called segment reporting. And then we'd have to [Technical Difficulty] separately, as we go forward as a company, continuously report on a total revenue but on how did we do in soft tissue this quarter, how did we do in the [ lag ] the following quarter, whatever. And basically, that's through perpetuity. There's no way to back out of it. And since we've got a platform technology, we really don't want to start that. And then the fundamental difference being in the United States, what investors are looking for is top line growth as quickly as possible. So it's getting new indications, getting that first hockey stick in, for example, for our soft tissue and for our vitiligo indications, which are coming up next year for approval, that's what that market wants. So we're a little bit cornered, if you will, but we're moving forward aggressively. And of course, at an 80-plus percent profit margin, we are going to hit profitability in a reasonable time frame. And when we do, we will be a very robust company because we will have all these various [indiscernible]. Michael, [indiscernible] a little bit more on OpEx, cash burn, et cetera?

Michael Holder

executive
#8

Yes, I can. And I just want to confirm that on a direct cost basis, our Burns business has become actually quite profitable. Just to follow up on that point, Mike. Yes. So as we look at our operating expenses over the next couple of years, basically, we're burning -- expending investing, if you will, around $7 million per quarter on average, $7 million to $8 million. And it's truly, largely an investment. The big drivers there are our clinical trials in vitiligo and soft-tissue reconstruction as well as our pipeline activities related to our two important devices, the Ease of Use device, which was just approved by the FDA, and we think that's going to make a big difference in the marketplace over the middle to long run. And then the fully-automated device that Mike mentioned earlier, both of those provide real advantages in the marketplace, as well as they help us significantly with our intellectual property. So we very carefully scrutinize these operating expenditures, these investments. And in fact, there is a very strong return on investment anticipated for each one of these pipeline activities. And as a result of that, whereas we've provided revenue guidance for 20% growth this year, we have not provided actual dollar guidance for years later. But I can say that our revenue growth rates are anticipated to increase very significantly, if not dramatically, in years '23 and beyond as soft-tissue reconstruction of vitiligo indications are commercialized. And it's those growth rates that really -- the underlying revenue as well as the growth rates that really drive share price. And so we think that we're significantly undervalued today, and we're continuing to hit a number of milestones in the face of macro conditions that are depressing the stock market and our sector in particular. But we think for those who are patient, really good things are going to come, relative to our share price, down the road.

Michael Perry

executive
#9

Thanks, Michael.

Michael Holder

executive
#10

So that kind of dovetails into another prevalent question asked in a number of different ways. And basically, the question is, what's driving your share price? Obviously, the share prices decline. Can you provide any more color as to what's going on with the share price? And what could influence it in the future?

Michael Perry

executive
#11

So we're disappointed with the share price as well. We believe that we're undervalued and that we're a very good buy opportunity, right now. And if you look at the analyst reports, they go along with that. It's -- I do not believe that it's execution on the side of the company. We have hit all of our milestones that we have laid out, going forward, despite COVID, and you see them on this slide here that is projected, and we continue to work through the nursing shortage and everything else. I really think, it's going to take the continued heads down on the business work to increase sales as we can in the burn sector, which is the smallest indication that we have. And then, as Michael said, moving forward, for those of you who are shareholders that are patient, there is going to be a nice hockey stick as we launch into soft tissue and vitiligo indications at the second half of next calendar year. There have been hedge funds in the U.S. that are selling, which have contributed to the depressed share price. But largely, what you're seeing here was a real hit due to COVID in the first quarter, or at the end of the first quarter in 2020. And then you can see, if you follow on the stock chart, every time we had good news, the stock goes up a number of percentage points, it goes back down and it goes back even further down. And now, the entire sector growth stops in general, are basically being put to the side, not a whole lot of investor interest, at least in the United States. And that will come back. But right now, it's really the focus is -- during COVID, the focus was on healthcare, especially those companies that were making vaccines or other elements of the supply chain relative to treating COVID. And now, it's really backed off, and it will come back. But that's all of the insight that I have. Michael, anything that you would add to that, relative to what's driving the share price and where we are, right now?

Michael Holder

executive
#12

Yes. I would sort of echo many of the same things. I think, macro conditions relative to inflation, the U.S. Federal Reserve announcements of increasing rates going forward to address the inflation, has driven a lot of institutional investors to safer grounds, caused rebalancing of their portfolios. And at least at this point in our company life cycle, we just simply don't have enough trading volume in the stock to soak up, if you will, that extra demand from the institutional investors to a certain degree, rotating out. But those sort of things will stabilize. As we sit here today, almost incredibly, our net valuation is about AUD 150 million, when you back out our cash position. And so that's only a little more than 3x our revenue multiple. And when you look at our very-likely derisk, we believe growth rates in the future, that's going to prove to be a bargain, in our view. So we think that things will settle out over the next quarter, and things are off to a good start, revenue-wise, here in the first quarter. So we feel very positive about the future. Back to questions. There may be -- there seems to be a little bit of confusion in the investor community, relative to what regulatory approvals AVITA has in non-U.S. markets, namely in Europe and Australia. And there appears to be a missed opportunity for revenue generation in those markets. Can you talk more about what regulatory approvals you actually have in those markets and what your future plans are to address those markets? And why not put more emphasis on them today?

Michael Perry

executive
#13

Great question. When we look at specifically Europe and Australia, where we do have a CE mark for Europe, we're maintaining that approval, and we do have TGA approval, broadly, for Australia. However, when one looks at the burn rates and what would be required to actually secure reimbursement in these markets for burns alone, it's actually a negative ROI. [indiscernible] new indication soft tissue and vitiligo,we are consistently assessing the opportunity to come back into Europe, come back into Australia and the value proposition. The ROI quickly turns positive, when we [Technical Difficulty] and have those data that we can bring back to these markets. And at that time and upon Board approval, of course, we will. The plan is to relaunch in Australia and in Europe, when the ROI is going to be positive and it's going to make sense to go forward from a business perspective, that's going to be a positive return on investment for the company. Yes. And that's -- again, relative to the regulatory approvals that we have, they're very broad. And TGA would -- the approval that we have would include soft-tissue wounds and vitiligo, for example, as does Europe. So it's just a question of getting the reimbursement in Europe going country by country and establishing the reimbursement price and then deploying salesforce there. So we are definitely going to be back. It's just a question of when.

Michael Holder

executive
#14

So there have been a number of questions that have come in the Q&A box here. And unfortunately, we're not going to have sufficient time to address more than a couple more questions. So just to let you know, we will try to get back to you with answers quickly after the call. But in terms of one or two more questions, now that COVID is abating, does AVITA plan on intensifying its investor relations activities in Australia? And can we expect to see Mike and perhaps the team over -- more often than in recent years?

Michael Perry

executive
#15

So that's a resounding yes to that question. I'm currently in Melbourne, and I will be traveling with key members of the team, the leadership team. And we've got some time to make up for. We haven't been able to travel from the U.S. to Australia for the better part of two years. And we're very much looking forward to reengaging on the story, showing what a really bright future the company has, in spite of where the share price is today. And actually, it's a good time to get in. But insofar as travel and presence in Australia, we actually are enhancing our investor relations. We're going to be expanding that program. And you can expect to see me and Michael and others of our team present on a semi-regular basis.

Michael Holder

executive
#16

Thank you. And with that, I'll just remind the viewers that the -- if you would like to review this presentation and the Q&A or if you didn't hear all of it, we are going to post this on our website shortly after the call. So it will be there for your review. And with that, I'll just turn it back over to Mike for any closing remarks.

Michael Perry

executive
#17

Well, I want to thank everybody for their questions as well as your attention through the presentation. I hope that you too are really seeing the value in this business. And it's truly a platform technology that's making a difference in patients' lives. And while it's taking a little while longer for adoption in burns, as our new indications come on board, I'm very much looking forward to sharing the story and showing a hockey stick increase. Again, I can't promise anything. There's macro conditions, war in the Ukraine, et cetera. But fundamentals of the business have not changed. As a matter of fact, they're better than ever. So with that, again, I thank you for your kind attention, and I look forward to seeing you in future travels. Thank you.

Michael Holder

executive
#18

And a special thanks to Monsoon Communications for ably hosting this event. Thank you.

For developers and AI pipelines

Programmatic access to AVITA Medical, Inc. earnings transcripts and 32,000+ others is available through the EarningsCalls.dev REST API. Plans from $24.99/month — full transcripts, speaker segments, full-text search, and the recently-added /api/v1/transcripts/recent polling endpoint for ETL pipelines.