AVITA Medical Inc

NASDAQ:RCEL

Earnings Call Analysis

Earnings Call Transcript 2023-Q3

[Operator]

Good day, and thank you for standing by. Welcome to the AVITA Medical Third Quarter 2023 Earnings Call. [Operator Instructions]. Please be advised that today's conference is being recorded.I would now like to turn the conference over to your first speaker today, Jessica Ekeberg, Director of Investor Relations. Jessica, please go ahead.

[Jessica Ekeberg, executive]

Thank you, operator. Welcome to AVITA Medical's third quarter 2023 earnings call. Before we begin, let me remind you that this call will include forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are neither promises nor guarantees and involve known and unknown risks and uncertainties that could cause actual results to differ materially from any expectations expressed or implied by the forward-looking statements. Please review AVITA Medical's most recent filings with the SEC, specifically the risk factors described within Form 10-Q for the quarter ended September 30, 2023 for additional information. Any forward-looking statements provided during this call are based on management's expectations as of today.AVITA Medical's press release for the third quarter 2023 results is available on our website, www.avitamedical.com under the Investor Relations section. A recording of today's call will be available on our website by 5:00 PM Pacific Time today.Joining me on today's call are Jim Corbett, Chief Executive Officer; and David O'Toole, Chief Financial Officer.I will now turn the call over to Jim for his comments.

[James Corbett, executive]

Thank you, Jessica. Good afternoon. And thank you for joining us today. I will begin today's call by discussing highlights of the third quarter, followed by an update on our priorities. Following this update, I will turn the call over to David, who will provide commentary on our financial performance for the quarter.I'm pleased to relay that our team drove third quarter commercial revenue of $13.5 million, representing a 51% increase over the same period in 2022 and marking our highest quarterly growth rate over the prior year. This achievement underscores our commitment to sustained growth. Our Burns business continues to drive our growth as it has all year. However, we could not achieve these results without the substantial contribution from revenues stemming from full thickness skin defects. I'll provide an update on this launch shortly.Moving on to our top priorities and recent activity; during the first quarter, I committed to defining our international expansion strategy during this earnings cycle and after months of strategic planning, I'm excited to unveil our plans today. Before doing so, I want to give credit to Terry Bromley, our Senior Vice President of Global Sales, who is leading our international efforts in addition to his U.S. responsibilities.First, our team has defined a focused international market for AVITA Medical. As we surveyed the globe, we looked at countries with sizable populations, robust healthcare systems and the resources to invest in our technology. These 3 factors are key, because our device is not just a product you can export without training into an unstructured healthcare system.To ensure proper device use and to have a meaningful impact on patients, trained medical professionals within a well-established healthcare system and strong economic support for treatment are fundamental requirements. When we apply these filters, the prime prospects are Australia, Japan and most of the European Union.Now, let's explore the plan to expand into the countries we have identified. As we weighed the advantages of internal sales channels versus indirect sales models, it became evident that the third party distribution model aligns best with our needs and provides the most benefits. The overarching advantages to this strategy center around knowledge, access and economics.First, we will benefit from local knowledge of distribution, reimbursement and commercial strategies within our targeted markets. Consequently, we will be able to leverage third party expertise to access these markets more effectively and rapidly, than if we were to build out new distribution channels within our organization.Lastly, since we are not establishing international channels through our own subsidiaries, this strategy will be a net contributor through our operating margin almost immediately.Terry and the team have already made great strides in our new expansion efforts. In fact, I am pleased to announce our newly hired Vice President of Europe, Stephane Cotte. Stephane, reporting to Terry brings over 25 years of global sales and marketing and services experience in the medical device industry, having most recently served as Vice President of Global Marketing at ConvaTec.Additionally, this morning, we announced our first European partnership with PolyMedics Innovations, a German based company specializing in the commercialization of innovative biomaterials and systems for wound treatment. Under our agreement, PolyMedics will be responsible for our expansion in Germany, Austria and Switzerland with an option to expand to additional European markets in the future.Founded in Germany in 2001, PolyMedics introduced its first product, a synthetic skin substitute to Germany and Austria in 2004. Today, their 2 flagship products are distributed across over 40 countries worldwide. PolyMedics maintains a specialized sales team, focused on burns and trauma, aligning seamlessly with the targeted procedures for resale. In fact, many resale procedures already utilize PolyMedics' synthetic skin substitute, making RECELL a complementary solution to their existing customer call points. We expect to commence training with PolyMedics before the end of the year, paving the way for a planned launch on the 2nd of January, 2024.Going forward, we plan to actively identify new distributor partnerships over the next 6 to 12 months to approach the markets that have been identified. I will provide updates during future calls.Turning to the PMA supplement for RECELL GO; in September, the FDA requested additional information on day 90 of the 180-day review cycle under the FDA's breakthrough device program. This request for additional information paused the clock on day 91.Upon receipt, we immediately began to prepare and submit a complete response to the FDA. Questions broadly fell into 3 categories. The first category, representing a majority, consists of clarification questions that we were able to address within several days. On the other hand, the second and third categories require additional in-house testing to fulfill the FDA's request. We've made incredible progress developing the data plan for the testing. In fact, all testing is already underway.Consequently, we now expect to complete the data set and submit our response to the FDA on February 28, 2024. Upon submission, the 180-day real time review resumes on March 1, 2024, positioning us for approval 90 days later on May 30, 2024, with an expected launch the following day.The first area of testing, focuses on human factor testing associated with the use of RECELL GO at different sites of service. The second area of testing in broad terms aims to establish the comparability of the autologous cell suspension between the current and the more controlled methodology of RECELL GO.Two examples here include the characterizing of the pressure used to disaggregate the cells and the soak time needed in the process. To date, over 17,000 cases have been performed under the current method of creating the autologous suspension. As one would expect, there is tension variability across the hundreds of surgeons who have implemented the current device, using their individual hand pressure.Second, the soak process is currently 15 to 30 minutes. But with RECELL GO, it will be 25 minutes each and every time. RECELL GO aims to control the variability introduced from these steps. We remain confident that the additional testing in progress will provide the FDA with sufficient responses to their questions.In connection to RECELL GO, I had previously mentioned that we co-developed the durable device and disposable cartridge with the contractor who performed the initial development and manufacturing. Earlier this year, we made the strategic decision to move the entire manufacturing and assembly process in-house to our Ventura facility.Originally, we had planned to launch RECELL GO simultaneously, with the transition of manufacturing to our facility in Ventura. An unintended benefit of the delayed launch is that it allows us to complete the manufacturing transfer to our Ventura facility, ahead of the commercial launch. We look forward to sharing further updates on our expanding manufacturing and assembly environment.I'd like to turn to the recent progress we have made with full-thickness skin defects. As I mentioned earlier, we did see an expansion in revenue following approval of the indication. Currently, we have over 100 accounts at various stages within the adoption process. Some are still with the Value Analysis Committee, while others are performing or have completed their initial cases and are on track for broader adoption.One interesting takeaway from our initial launch pertains to the broad scope of the expanded label for full thickness skin defects, which allows us to pursue many different applications and forms of skin grafting. Consequently, we have found we have access to a wider user base, within a single facility than initially anticipated, often resulting in a lengthier sales process compared to that of burns, but a much larger market.In fact, a few weeks ago, I had opportunity to observe a top burn surgeon perform a full thickness skin defect procedure on a road rash patient at a medical center, the expanded label represents a tremendous opportunity within a dynamic environment, and we continue to affirm that this indication has high growth potential in a market that is about 10x the size of burns.Turning now to our cash position; in October, we announced that we secured up to $90 million of non-dilutive debt financing with OrbiMed. With several near term initiatives on the horizon, the capital serves as a backstop to our cash position, allowing sustained growth and expansion. We strategically pursued a debt financing to avoid significant dilution to our shareholders due to the uncertain equity market conditions that existed in recent times.Additionally, we are confident this financing provides us with sufficient capital to achieve our growth goals and positions us to reach profitability during 2025 without the near term need for additional equity financing. While we do not have the explicit need for the 2 additional tranches of $25 million each, having access to this capital provides us with valuable flexibility and optionality. We firmly believe our partnership with OrbiMed is the most shareholder friendly approach to strengthening our cash position. David will discuss the financial details of the transaction.One detail I'd like to underscore is that in the past communications, we have said that we expected to reach profitability in 2025 subject to a vitiligo channel investment. Today, we are eliminating that vitiligo expansion qualifier, further evidencing our bullish view on the growth and profitability of our company.Let me now provide an update on the vitiligo initiative; as we have mentioned previously, we are in the process of securing reimbursement for vitiligo. To begin this process, we have initiated a 100-patient post market study called TONE. TONE will evaluate repigmentation using the RECELL device and will also seek to measure quality of life after treatment of stable vitiligo lesions.The 3 quality of life measures are patient satisfaction, clinical satisfaction and patient mental health. We believe developing these quality of life indicators will help create a basis to understanding the impact of vitiligo on the mental health of the patient and the associated healthcare costs of treatment.We expect full enrollment of TONE by the end of February 2024. The trial design then includes 6 months of patient follow-up. With that in mind, we expect to submit for publication by the end of 2024.Additionally, to support reimbursement, we are in the process of initiating a separate health economics study to capture the longitudinal healthcare costs for a vitiligo patient. For this study, we will collaborate with a leading healthcare economics firm and a team of physicians for guidance. We expect to publish this study by Q4 2024. Collectively, we believe that these studies will demonstrate how treating vitiligo with RECELL can significantly reduce the lifetime healthcare costs of patients.As we work to establish reimbursement, it's important to appreciate that CMS will play a limited role, given that the vitiligo patients are an average age of 40 years old, and are not Medicare beneficiaries. Consequently, we will focus on commercial payers, who will stand to benefit economically by providing coverage of RECELL for the repigmentation of stable depigmented vitiligo lesions.The study publication dates put us in position to begin payer coverage discussions in Q1 2025. It is also important to recognize that commercial coverage decisions are geographically determined by state and/or region. As such, we will focus on larger populated states first, where insurance is governed by state law. This will result in a rolling launch of vitiligo. We will update you on our progress with the 2 studies and with the major policy payers throughout 2024 and 2025.Given the phased rollout caused by reimbursement timing, we will not expand our commercial team in advance. We anticipate that the initial phase of reimbursement coverage will likely begin regionally, as coverage is established in Q3 2025, with the appropriately sized commercial support as coverage is established.From a portfolio point of view, we are looking to expand our strategy. We plan to become a full scale wound care company. Accordingly, we are actively evaluating dermal scaffolds, skin substitutes and wound dressings for co-development opportunities. Currently, we are performing early animal work and will keep you informed of our activity and progress in this area.Looking ahead, there are a number of exciting topics that we will discuss in February on our 2023 annual results call. As standard, we will provide guidance for the quarter, and for the full year 2024. Additionally, we will provide guidance on the quarter in which we will reach cash flow breakeven without the expressed limitation of the 2025 vitiligo sales channel or any other limitation.Lastly, we also provide detail on our ongoing commercial expansion efforts. As previously mentioned, we plan to maintain small sales territories, as determined by geography and revenue to keep our growth rate high.In closing, we remain committed to unlocking shareholder value through the continued growth into our expanded indications and the expansion of our portfolio. I look forward to sharing updates on our progress.With that, I'd like to turn the call over to David.

[David OToole, executive]

Thank you, Jim. Good afternoon. We delivered another strong quarter of financial results. In the 3 months ended September 30, 2023, our commercial revenue increased by 51% to $13.5 million compared to $9 million in the same period in 2022. As a reminder, beginning in Q1 of this year, we have achieved significant commercial revenue growth rates of 40%, 42% and now 51% for the current quarter compared to the same quarters in the prior year.The increase in commercial revenue for the current quarter was largely driven by broader surgeon usage as well as deeper penetration, especially within smaller burn procedures.Additionally, our launch into the full-thickness skin defects market and the subsequent and continuing acquisition of new accounts through our expanded label, contributed to our revenue growth.Gross profit margin was 84.5% for the quarter compared to 83% in the same period in 2022. The gross profit margin for the quarter was at the higher end of our full year guidance of 83% to 85% that we provided last quarter.Total operating expenses for the quarter were $21 million compared to $14.2 million in the same period in 2022. The increase in operating expenses is primarily attributable to an increase of $5.1 million in sales and marketing costs, as a result of the expansion of our commercial organization in preparation of the launch of full-thickness skin defects that occurred last quarter. Additionally, we incurred an increase of $0.6 million in R&D costs and an increase of $1.1 million in G&A costs, which was primarily due to an increase in stock based compensation expense.Net loss for the quarter was $8.7 million or a loss of $0.34 per basic and diluted share compared to a net loss of $5.6 million or a loss of $0.22 per basic and diluted share in the same period in 2022. As of September 30th, we had cash, cash equivalents and marketable securities of $60.1 million compared to $86.3 million as of December 31, 2022.As Jim mentioned, we entered into a credit agreement with OrbiMed on October 18th. The debt facility provides us access up to $90 million, of which $40 million was funded at closing. Two $25 million tranches are available at our option. The first $25 million is available on or before December 31, 2024, but only if our net revenue is $75 million or more for the last 12 months. If and only if we draw the first tranche, then the second tranche of $25 million is available again at our option, on or before June 30, 2025, but only if our net revenue is $100 million or more for the trailing 12 months, prior to the month of a drawdown of the second tranche.At the current time, we do not have need for either $25 million tranche and given our revenue growth and expectations of reaching cash flow breakeven, we do not foresee a need to take down either of the $25 million tranches before they expire. With our current cash balance and the $40 million funded at closing, we are confident that we have sufficient cash reserves to achieve our goals and reach profitability in 2025.Turning now to our 2023 guidance; for the fourth quarter of 2023, we expect commercial revenues to be between $15.3 million and $16.3 million. At the boundaries, this reflects a growth rate between 64% and 73% over the prior year fourth quarter.Lastly, we are maintaining our 2023 annual revenue guidance of $51 million to $53 million provided last quarter, which within these boundaries would reflect growth between 50% and 56% over 2022.With that, we thank you for joining us. And now, I will turn the call back to the operator for your questions. Operator?

[Operator]

[Operator Instructions] Our first question comes from Joshua Jennings of Cowen.

[Joshua Jennings, analyst]

Congratulations on all the progress on multiple fronts. Jim, wanted to just ask about the international expansion plans and I was hoping you could just remind us about THE CE mark and the label. I mean, does PolyMedics initially and other partners down the line going to have a broad indication to go after? And then the follow-up on this question is just that will you ultimately pursue CE mark for RECELL GO as well? My understanding is you have approval for the standard RECELL kit now.

[James Corbett, executive]

We do. Josh, those are good questions, though, let me try and line them up here. First, we are MDR compliant. So we will be submitting the technical file for RECELL GO and expect a midyear timing July availability for European RECELL GO availability, so that's the one. With respect to the labeling, the labeling is identical to, burns, full thickness skin defects, and vitiligo.So the labeling for -- that's reflected in the U.S. market is reflected in the European Union. And so therefore, we've fully enabled to sell with our ease of use '19 and '20, January 2nd. So we're, I think, ready for Europe.

[Joshua Jennings, analyst]

And then I wanted to ask about the 2023 guide and the implied fourth quarter revenue performance and just thinking about that nice sequential growth that you're expecting to deliver. Can you just remind us about seasonality in burn cases, and if there is any seasonality tailwinds in the fourth quarter? And then is the majority of the sequential revenue growth 4Q over 3Q coming from the full tissue skin defect indication?

[James Corbett, executive]

Okay. The seasonality question, we did an in-depth claims review of this and we looked back 3 years, and it's really rather remarkable. If you took all the claims for burns and calendarize them into -- a calendar year and not separate fiscal calendar, the spread is 25%, 25%, 26%, 24%. So virtually no seasonality from burns. So that's kind of a good news thing. There is a -- and the answer of your question, our underlying growth still is very heavily, burns is growing. We are gaining share in burns unquestionably. In full thickness, we're gaining momentum also.So they are building on each other, but of course, full thickness started in July, which at zero, right? So it's got a ways to go to catch up to the burns revenue growth rate. So no seasonality do we expect. The full thickness is gaining momentum. It's a little bit like a wave coming ashore, Josh, if you think about it that way, right?We started quite a number of new accounts at, so to speak, time zero and they all progress forward going through that committees doing additional cases. And as I mentioned during my prepared remarks, we are finding many more people to influence physicians within the hospital, because there are so many types of skin grafting procedures that are on label. So progress is good.

[Operator]

Our next question comes from Matthew O'Brien with Piper Sandler.

[Phillip Dantoin, analyst]

This is Phil on for Matt. Just kind of in the same vein as Josh on the international expansion plan. Can you walk us through the thought process of going international versus further penetration into the U.S. market, as you just launched into that new indication? And then a follow-up, how quick can that international revenue start to ramp in '24?

[James Corbett, executive]

So first of all, we're really all about the fact that we are the premier wound treatment that is available in the world. So U.S. is a huge market but so is Europe and Australia and Japan in our view. So that sequential growth that you have noted during the call, and I think David highlighted 40%, 42%, 51%, and now we're expecting to grow between, 64% and 73% in the fourth quarter. So the international for us would have been a different decision if we were doing it ourselves. That would have required an additional cash investment that would probably not go positive for 3 to 5 years.Doing it the way we're doing with established partners really leverages their local expertise and causes us in those markets to make a contribution margin that is positive and is one of the reasons why, and during the February call, we're going to be providing guidance on the quarter in '25 that will be profitable. So this is a contributor to it. So we're doing so without having to spend a lot of cash, without having to add a lot of manpower, but it's going to contribute from an operating margin point of view. So that's how we are thinking about that.

[Operator]

Our next question comes from Brooks O'Neil with Lake Street Capital Markets.

[Brooks O'Neil, analyst]

I have a couple of questions. I guess I'm going to start off, Jim, you were just talking about the accelerating adoption in the core burn market, and I've always believed that your product is so superior to the current standard of care. It's been a little surprising that penetration in the burn market was somewhere in the range of 20%. And I'm just curious what you're finding as adoption is growing. Why did it take some of these doctors, time to adopt it and what do you think you need to continue to penetrate that large burn market?

[James Corbett, executive]

I think there's 2 factors that are happening. RECELL is a first in category type product and those do take time sometime in the early phase, that's just one fact. What has really changed the ballgame, I think, for us was, as you know, the burn sales team and the full thickness sales team are the same sales team.So what we've done is we've given those burn centers now and those sales territories are now smaller in geography, smaller in revenue size. And so they're not just selling full thickness, they're selling burns where we already were selling burns, but we have a smaller call pattern. So I think that's really making the difference for us is that you can look backwards and say, maybe we should have invested heavier sales force earlier, but certainly, we're getting the payoff of doing it now.

[Brooks O'Neil, analyst]

So second question I have is, as you have thought about the significantly larger indication in the full thickness skin graft area that goes beyond acute injuries that I think are generally treated in the trauma centers and the burn centers and whatnot, to include the chronic wounds or chronic full thickness skin defects. Have you given a lot of thought to what it's going to take to penetrate the kinds of facilities and get to the kind of doctors who treat chronic wounds?

[James Corbett, executive]

We have done a fair bit of work with that in mind. What we're thinking about though first, because their patients are getting treated now, we're getting case reports of RECELL with a chronic wound, for example, a venous leg ulcer or such. What we note is clinical data is what we're thinking about first as opposed to access.And so we're in the process of assembling case studies where we can. We have a couple of early stage planning for some specific indication clinical studies, like tumor excisions come to mind as another one that is quite large. And so I think, we're going to lead being the company that AVITA is, which is we're going to focus on the consultative care that the physician is attempting to provide for their patient, we're going to bring to them case examples, clinical data examples, small case series.In some cases, we're planning some bigger studies and that's really how our sales team operates and that is in a very technical, scientific and consultative manner. So that's what we're thinking about right now and it will certainly mean that we'll learn some new things.

[Operator]

Our next question comes from John Hester of Bell Potter.

[John Hester, analyst]

Just a couple of questions from me. Jim, you just talked about some case strategies, and cases in venous leg ulcers, tumor excision, that's encouraging; have you seen a trend emerging now for the sorts of labels, the sorts of wounds that surgeons are initially using the expanded label indication?

[James Corbett, executive]

Well, by the way, you're up early, John.

[John Hester, analyst]

Well, I'm a lot closer to the weekend than what you are, Jim.

[James Corbett, executive]

I appreciate that. John, I think trend is a little bit too strong of a word, but they're coming to us with the cases. And in many cases, we've got some historical experiences from other parts of the world where RECELL was used in earlier years, and we share with them what we know and what we don't know. And there has been a number of cases that are quite unusual. For example, there's some sacral skin grafts that are essentially bedsores, so we've had a number of those get treated.The trend is too strong but it's certainly more than one, it's happening. And so we're trying to get ourselves out ahead of that, so we can act as a resource to our customer. Because it's clearly, they are having trouble treating some of these chronic wounds and RECELL does appear to provide quite a benefit to many of those patients.

[John Hester, analyst]

Well, it sounds like it's still early days there. Just switching to Europe, obviously, average selling price is going to be a lot lower in Europe. Can you sort of give us any guidance there on what you are expecting for average selling price relative to the U.S. market? And of course, you know even you've got your distributor margin there as well.

[James Corbett, executive]

That's right. We will have a lower realized sell price, because, of course, distributor -- we have an average selling price sharing model with them. However, you may also recall that our cost of manufacturing is very heavily fixed costs, and at the rate of our volume growth, we're talking still an accelerated growth line, as we go into Q4, which has been happening all year, 40%, 42%, 46%, going to be 64% or better in Q4. That is eating up the cost of goods problem.So we're still going to get a nice contribution margin. We will get a lower ASP. That said, it will contribute to our march towards profitability. So some volume won't hurt us and we won't spend as much.

[John Hester, analyst]

And just finally, very last question for David. I noticed the R&D expense dropped in the quarter, David, relative to the June quarter. Can you just give us some insight as to why that was the case?

[David OToole, executive]

Really what that comes down to, is we had a slower enrollment for our TONE study, which as in this quarter is accelerating, because we are still planning to have that TONE study fully enrolled by February. But sequentially, it really comes down to the fact that we didn't have as much of enrollment in the TONE study.

[Operator]

The next question comes from Ryan Zimmerman with BTIG.

[Iseult McMahon, analyst]

This is Izzy on for Ryan. So last quarter, you guys noted that uptake of RECELL in key burn -- you were seeing strong uptake of RECELL in key burn accounts without adding new burn centers. I was just wondering if this was a similar trend that you're seeing this quarter or if you're starting to see increased penetration within new accounts?

[James Corbett, executive]

Well, yes. The point I was making actually during last quarter was that we had not added burn centers in over a year, because we're in all of them virtually. And so what we're seeing is penetration in the burn centers that's related to the full thickness launch. Half of those burn centers are trauma centers and with a smaller sales territory, because we expanded the sales team a lot. We are seeing both of those phenomena. We're seeing penetration in burn centers is going up as a consequence of a smaller sales territory, but we're also seeing an uptake in utilization of RECELL in the various and many full thickness skin defect indications. So it's a -- where there's a burn center, there's a double opportunity for us.

[Iseult McMahon, analyst]

And then just to follow-up on that. So who are the early adopters that you guys are seeing for the full thickness indication? Is it mostly burn surgeons, are you seeing trauma uptake or is it kind of a combination of everyone?

[James Corbett, executive]

Well, for certain. In terms of new users heavily dominated by trauma surgeons. Now, of course, by definition burn surgeons are trauma surgeons, but not all trauma surgeons are burn surgeons, if you then can put that Venn diagram together. So the new surgeons we're adding principally are trauma surgeons but we're getting new indication utilization by burn surgeons who now have a more open label.So there's a lot of opportunity out there for us right now. That's why we really expect this rate of growth issue to dominate the headline here for our company on the boundaries of the coming quarter, right. We're looking at 64% type growth, which will be our fourth consecutive acceleration into another decile. So we're really quite bullish at the moment.

[Operator]

Our next question comes from Ross Osborn of Cantor Fitzgerald.

[Ross Osborn, analyst]

Maybe just one for us on OpEx. Now that you've had full thickness out for a handful of months, how do you feel about the number of reps you hired ahead of that expanded indication? Do you foresee the need to increase headcount next year or no?

[James Corbett, executive]

Straight away, Ross, we feel very good about the number we hired. Having said that, when we foresee the average territory size approaching 2 million, we will be expanding, because that -- there is so much opportunity out there. I happened to be traveling and had dinner with some physicians and one of our CTSs, which are -- they are commissioned, but they do a lot of the case coverage.We were in New Orleans and this particular very good rep of ours was talking about covering the case in consecutive days in Jackson, Mississippi, New Orleans and Memphis. So we are far from being geographically populated. So I'm sure that during next year -- and you might recall in my comments during the script, we do project that next year we'll increase again our commercial team.

[Operator]

The next question comes from Madeline Williams with Wilsons.

[Madeleine Williams, analyst]

I was just wanted to ask, you sort of mentioned that with the label, expanded label indication that there's sort of a longer, I guess, sales effort there. Is that in regards to sort of more -- education for those new sort of trauma surgeons that you're bringing on, in regards to the retail device?

[James Corbett, executive]

In a sort of indirect way, Madeline, if you think about it this way, [ a burn center is ] real straightforward. There's a head burn surgeon in every hospital, you go right to that person. What we find with full-thickness, is there is many constituents with many different indications. And so when you go to the value analysis committee, you find yourself being asked about many different indications. So there is -- what I would describe as a time element that slows us down a little bit, but it's benefited by the expanded opportunity. So does cut both ways.

[Madeleine Williams, analyst]

And then so I guess with the Q4 expectations, I mean, is there any sort of color as to what you expect for the rest of world, I guess, opportunity? Does that sort of come through straight away or is it mainly just growth in those soft tissue and/or the full thickness and burns?

[James Corbett, executive]

I think for the fourth quarter, we're really focused on what happens in the U.S. in full thickness and in burns. Rest of the world will start to take some time to develop, but it'll become more meaningful as '24 rolls on.

[Madeleine Williams, analyst]

And if I can just ask one final question in regards to the vitiligo. I mean you're obviously doing the studies now and importantly the TONE study. But just sort of maybe a comment around what your expectations are for sort of pricing, in regards to vitiligo and reimbursement? And knowing that it's sometimes difficult to get those commercial payers, I mean, have you already started those conversations? And I guess, what has been the feedback if you have?

[James Corbett, executive]

Well, first, it's a little bit early for us to answer those questions, because you need the data from TONE, you need the healthcare economics data that we're working on with the healthcare economics firms. So you really need those inputs. So with respect to ASP, what kind of adoption one might expect, I think, we're a good nearly 18 to 24 months away from being able to really give that type of level detail in terms of guidance.

[Operator]

This concludes the question-and-answer session. Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.