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. AVITA CEO, Jim Corbett, is in Australia for a Sydney, Melbourne roadshow this week following last week's strong first quarter results. Let me point out, you can submit questions using the Q&A function, and we'll get to them after the presentation. Presenting today is CEO Jim Corbett, and assisted by CFO Sean Eakins. I'll now hand over to Jim.
Good morning from Australia. I am actually just fixing an echo problem. One second. With that said, I am doing this webinar from Australia, and it's part of my investor cadence. Every quarter following our earnings release, I spend a week here in Australia between Sydney and Melbourne for the purpose of communicating with investors and potential investors as we, as you know, trade on both ASX and NASDAQ, and we want to be able to meet with investors and answer questions. Some of you may be new to the call. I'm gonna begin by providing a big picture of who is AVITA. We are a regenerative medicine technology company. We sell a technology platform called the RECELL System.
It's fascinating because what it does is we take the autologous sample from the patient, and we disaggregate it and suspend it in a cellular suspension, an enzyme suspension. When it's in liquid form and the cells are all free, so melanocytes, keratinocytes, fibroblasts, we suspend them in that solution and put it in a spray-on applicator, prepare the wound, and spray it on for treating that wound. That is how we deliver the cells of skin for the skin graft. It's rather amazing. One of the biggest benefits is that it uses dramatically less autologous sample from the patient. It's not well known that when you take a skin graft, you're taking it from somewhere else on the patient, and you have to also treat that location where you take it.
If it is significantly smaller, that is far better for the patient. What we found is that patients in our burn centers, and this is in our publications, is that the patients who are treated using RECELL actually get out of the hospital, go home earlier, and have less scarring. This is a economic benefit for the treatment and the healthcare system. It's less burden on the patient because of smaller sample, and less scarring means their life is better going forward. A really, it validates because in the reimbursement system of the U.S. where we're currently marketing, they receive a fixed payment to treat the patient. What they find is they pay over $6,000 of additional cost to use the RECELL System, knowing that the patient goes home earlier, the hospital gets the benefit. Really an amazing technology.
Our current U.S. indication is acute thermal burns. I've described how this works conceptually. Now you can see how this works in practice. 1, we take that patch of tissue. We put it in the RECELL processing kit after you disaggregate the cells, then we spray it on. You can see on the right, on a cellular level, how this occurs. A macro look at because indications is all about market access and how big of a market we can serve. We currently are selling in the burns market, and we are approved for use of burns for burns use rather, in the hospital and in an outpatient environment through what's called a transitional pass-through code.
We currently are expecting approval of our PMA supplement for soft tissue repair and reconstruction, June 7th . That is the subject of an application in a clinical trial we did in the last year and a half or so, and that was submitted in December. It has what's called a Breakthrough Device Designation. That designation carries with it a real-time review. Normally, in a PMA review, it's 180 days, but every time they ask you a question, they stop the clock like a football game. When you answer, they start it again. In the real-time review, they ask us a question, we have usually one to three days to answer, and the clock keeps running. It's a very dynamic review. We're very, very late in process. We're very confident about our June approval.
We're also pending a vitiligo review. That was submitted in June. It's a separate indication. For those of you who don't know, vitiligo is an autoimmune condition that results in loss of pigment. A completely different study. In fact, it's not a PMA supplement derivative of the burns, but rather its own independent PMA. That has some relevance we'll discuss a little bit later in the call. We expect that approval approximately June 17th . I get to those dates because they're public dates. Meaning 180 days is the re-regulatory requirement by the FDA for them, and they only come off the real-time review if there's a material deficiency. In both of these cases, we have not had no such material deficiency, and we're progressing in the review in a very orderly manner. We're really quite excited.
We're gonna talk a little bit in this call about the RECELL GO device. We don't really expect the approval in Q1. We actually expect it January 1 because we plan to be the 180 day mark will be June 30th plus 180 days. That is a big topic, and I'll cover it more during the call. Let's talk about our recent earnings release. First, commercial revenue growth was 40% over the same quarter of the prior year. Let me put that into bigger perspective for you. You may remember that we committed this year to going to quarterly guidance. Quarterly guidance plus annual guidance every quarter, updating the annual guidance. During this call, we had previously provided Q1 guidance of $10 million-$11 million. We achieved $10.5 million.
Right in the middle of our guidance. That, for us, is nearly exactly where we like it. That was 40% up over the prior year. At the same time as we gave that guidance, we gave the guidance for the year for $49 million-$51 million for the year. That on the top end was an excellent performance for us for the first quarter . We also previously guided to the expansion of our U.S. sales organization. Prior, we had 30 people in that organization calling on the 145 burn centers.
With the soft tissue repair indication, our market opportunity goes up rather dramatically, and therefore we've made a commitment to expand our sales organization from 30 to 70 people during Q2 ahead of the approval to be fully trained, integrated into their new territories by June 1st. As of today, we have filled all of the positions. My slide says 69. The latest news is 70. We're ahead of schedule. Our onboarding and training is ahead of schedule. The fact that we're gonna get approval earlier than July 1st is going to enable us to begin promotion of the market for soft tissue repair earlier than prior, presuming that approval on June 7th. This is a really great development. Incidentally, recruiting has been exciting for us. People for the different territories.
Frankly, we target individuals from certain experienced backgrounds in treating wounds and surgeries, understanding our business that we have RECELL to promote to. We had numerous candidates for every role. We filled the six new sales management roles. We went from two to eight by March 1st, we started making offers to the sales team April 1st. Here we are, May 15th, and we're fully loaded and ready to go. We have an excited team, we have an experienced team, and we're ready for this launch. Vitiligo, that indication for those of you who you recall, autoimmune condition, loss of pigment. We expect FDA approval around June 17. We need to pursue reimbursement strategically to have RECELL reimbursed in the office site of treatment. If you recall earlier, I described reimbursement in the hospital and in the outpatient environment.
For patients who have vitiligo, they're not suffering from an acute injury. They're having their pigment transplanted, essentially. It uses the exact same technique in RECELL System. We have work to do to prepare for reimbursement that we expect to be able to achieve in 2025. In past calls, I referred to the importance of automation as the essential element to really expand adoption. As you recall from my explanation, you disaggregate skins manually. In the case of RECELL GO, it is a durable piece of equipment that we will provide to the hospital.
The RECELL System will be modified to create a cassette that will receive the tissue before it's disaggregated, and the enzyme will be loaded into the RECELL GO device, and you will press a button, and the physician and staff can go about treating the patient while the disaggregation is underway. This changes about everything. It makes it so the training that currently is a burden to the hospital, and it occupies almost 50% of our sales time will go to basically five minutes. It is so easy. We taught one of our board members last week how to do it, and she could execute it in one minute. It was really kind of amazing. Of course, she has no medical background as a training medical professionals or anything like that, but she could operate the machine within that timeframe.
Really exciting. What does it change? It changes the training for the hospital, changes the training for our sales team. It allows for physicians, as we broaden to many different hospitals and many different users, the ability to use RECELL without having to have so much new training. This gives you the summary of where we are with the soft tissue repair opportunity. Let's talk about the many synergies that exist here. First of all, soft tissue repair and burns. Build burns up this way. There are 35,000 RECELL-eligible patients per year in the U.S. market by looking at claims data that are that would be candidacy to have RECELL treatment. 25,000 of them are in a burn center. 10,000 of them exist in level one and two trauma centers.
We have been configured to only call on the 25,000 burn patients that are in the burn centers these last few years of AVITA's early commercialization. When we get soft tissue repair, we merge the sales team into one to treat acute wounds, and they will call on the 145 burn centers and about 1,000 level one trauma centers. It happens that upon approval of soft tissue repair, 50% approximately of the burn centers are level one trauma centers, and we will immediately be able to promote the use of RECELL for the broader indication. This is a Core Synergy. Secondly, and perhaps even the biggest synergy, is that the inpatient reimbursement codes and DRG for burns apply directly and the same to soft tissue repair. Secondly, outpatient transitional pass-through code that exists for burns applies for soft tissue repair.
We're launching into a market that's substantially bigger than burns because the market we're going into is approximately 110,000-120,000 patients per year. You add that to the 25, and then, of course, the 10,000 patients we haven't been calling on will now be in our call pattern for our sales team. We expect very quickly to start penetrating that additional burns opportunity, which mathematically 30% of the market. The synergies are completely aligned. Someone says, "Well, what types of things do you treat with soft tissue repair?" Really, there's a range of things. It's a very broad indication.
As you can see on the screen, the overwhelming is the fasciotomy and debridement, which is basically where the skin gets disconnected from the vasculature and the skin dies, and then you need to cut away the skin and reconnect it and regraft it. Necrotizing skin infection is the same type of treatment. Both of those are what I call the doctor. They're treating what the doctor does. The doctor causes the treatment by cutting it away, and then there has to be a tissue graft associated with that. On the other side are the acute wounds. Those are things the doctor fixes. There's a flap donor site abrasion like road rash. There's crush from a big trauma or an amputation.
Although these become less and less likely, in fact, in the aggregate, a tremendous number of different types of indications. You just heard me describe all of this, and now you can see it in the visual. The burns market and soft tissue market have great synergies. The burns procedures, we have 300 surgeons trained already who are, some of them, both burn and trauma surgeons, and they exist in that 50% of the burn centers that are already level one trauma. We're commencing our activities to prepare the level one trauma centers with our sales activities of today. Eligible procedures are nearly 150,000.
That is just, you know, depending on where you want to take your multiple, because one of the phenomenon's now, just a subtle thing, is that in burn cases, sometimes you use two or three RECELL kits per patient. Most likely in the soft tissue market it'll be closer to one on average. In some respects, the real market opportunity here is expanding approximately 5x from what we have currently been calling on. This is just one of those rare moments where you have a new best-in-class transformative technology and treatment that is proven clinically and in the clinical research. It's proven by its market adoption. Our $34 million last year in revenue was all in the burn market in the U.S., and it's reimbursed. This almost never happens in this type of order.
Of course, I am giving you the information faster than the slides, but to reemphasize all these burns, the next step for us is really to get to the Value Analysis Committee of these level one trauma centers. By doing that, we enable our opportunity to open up new accounts. Over the next year, we're gonna go from 145 and make progress to be in all 1,000 over the next one to two years. Really a lot, a lot to do, but a lot of opportunity for our technology to help patients have less tissue use for their autologous sample. It'll help them leave the hospital sooner. It'll help them have less scarring, and it will bring RECELL to more patients and make a real difference in the quality of their care.
A moment about vitiligo. Take a look at the right's picture. The approval we expect is rather awesome because what we're demonstrating is that we can transplant pigment. Technically, when I earlier mentioned that the FDA reclassified our PMA supplement as a PMA, it became rather obvious because what they were saying is we're not treating a wound, 'cause we're not. What we in fact do when we do RECELL for a vitiligo patient is we do a dermabrasion at the site of the lesion, and that would be a stable segmental vitiligo patient. Stable means that the loss of pigment is not expanding. You do a dermabrasion, you take the autologous sample, you create the RECELL spray, and the dermabrasion allows the tissue to accept and receive those keratinocytes, fibroblasts, and most importantly, melanocytes, which are the pigment cells.
That's how it works. That market opportunity is somewhere 5x the size of our current market, so it is a big place to go. That said, site of service reimbursement is a task for the company to get accomplished in the next two years. As such, none of our forward revenue projections include nor are necessary for us to maintain a high 50% rate of growth in that range over the next three to five years. Vitiligo is on top of that. Really an exciting opportunity, but requires a lot of market preparation. Really, 2023 is a great year for AVITA. It's an inflection year. We will increase our rate of growth in real terms, absolute USD value.
We will grow our company just at midpoint by 50%, nearly 47% at midpoint of guidance. In fact, be on pace next year to grow at a much higher rate. Soft tissue repair expands our market opportunity hugely, and we have in our pipeline vitiligo. RECELL GO is a great enabler. Back up Imagine. Right now, 50% of our selling time is training. That goes to something like 10%, and that affects the hospital staff and allows us to go to more hospitals. That's what RECELL GO does now. In the dermatology office, a dermatologist doesn't have time to spend 30 or 45 minutes disaggregating cells. He or she doesn't have to do that.
They take the sample, put it in RECELL GO, and leave the room, go treat four or five other patients, come back, it's ready. They do the dermabrasion, they treat the patient. Our international expansion is completely dependent on RECELL GO. When we go to countries around the world to expand our market, we're going to be looking at the reality that either they would have to train the way we train in the U.S. today, or either we would provide it or they would provide it, and yet we're splitting the revenue and the margin. That's not a good economic model. RECELL GO changes the model completely. It won't require that level of training and ongoing support.
One of the other items I've guided to is a description of our international expansion and the strategy by the end of this year. I can give you a really soft big picture view of how that works. It really works considering three elements. Element one is size of population of the country we go to, the healthcare system that they have and can they support the type of treatment RECELL is used in, and economics. Is that country's economic health strong enough to support the treatment of these patients to be able to pay for it? I can rather simply tell you that's a 20-25 country population, and they sound very obvious when I say them. It's Australia, it's Japan, it's United States, it's most of Western Europe.
How we come to those, some of those will be partnerships, some of them may be big enough opportunities where we justify an AVITA subsidiary. We'll have all that laid out for you by Q4. A little overview, 23 versus 22. As I mentioned earlier, a 40% growth over prior year, we describe that always in commercial sales. Commercial sales were $10.458. As such, we're still remaining in a very strong cash position with nearly $80 million. We have sufficient capital to execute our strategy. We have a high growth momentum already building in the burn market, we're going to gain 30% size of the burn market in the coming quarters. We'll have RECELL GO to make it grow faster, the same for soft tissue repair.
We're in a very strong place. To kind of reemphasize going forward, our Q2 guidance delivered during the call is $10.7 million-$11.7 million. This is all before the soft tissue repair launch. Effectively, although we're clearly going to start being able to promote in June, the fact of the matter is our guidance, we don't know that. Therefore, we've kept our guidance right where it belongs, which is focused on the burn market for Q2. Our annual guidance was affirmed. This is prior. Our $49 million-$51 million remains intact. We're on schedule as far as our forecasted revenue growth. The milestones are the PMA supplement for soft tissue, the PMA supplement for vitiligo, and the submission for RECELL GO by June 30th. Incidentally, it has Breakthrough Device Designation.
Therefore, we're planning on 180 days. I happen to know we have just completed the validation in a comparable to RECELL in the last few days, and we are on pace for that submission June 30th. We are really excited about our progress, and we see a lot of upside going forward. Looking back this at just a full summary. Our burns continues to grow. We had a slightly slower quarter in the first quarter, not attributable to any third-party matter. We expect that to pick back up. Particularly, already we are in level one trauma centers focusing on those 10,000 burn applications which we have indication for. That is what our sales team is doing in the early days of their expansion. Soft tissue repair, five expansion of our total market opportunity. Vitiligo is our pipeline.
Look for 2025 to be our reimbursement time and when commercial revenues really begin and become material. RECELL GO becomes the fulcrum. It'll help increase adoption in burns. It'll increase adoption in soft tissue. It will enable international launch, and it makes vitiligo markets possible. This is a big picture outlook for our company for the next three to five years. With that, I think, we're ready for questions.
Thank you, Jim. We'll now move to the question and answer session. If you have any questions, you can continue to submit them using the Q&A function. I'll now hand over to Sean Eakins to run the Q&A.
Thanks, Rudi. Jim, this question comes, it's, there seems to be some confusion regarding earnings per share in AUD and USD. Can you clarify as to whether you report in both currencies?
Yes. There was some confusion. There was a S&P Bloomberg summary of our earnings, we only report in U.S. dollars. Unfortunately, there was a table comparing our U.S. dollar performance to Australian dollar analyst report. When you compare them, you were comparing U.S. dollars to Australian dollars. We've issued a clarification of that, we only issue in U.S. dollars, I refer you to our 10-Q and our recent earnings release, which are in U.S. dollars.
Thanks, Jim. Next question is, your gross margins have improved. Can you let us know how we should be thinking about this in the future?
You know, I can. We have a very strong cost position, and we constantly are thinking about how we can leverage that. Let me give you a couple examples. First of all, approximately half of our cost of goods is fixed overhead in the building that we assemble the kits in. As we double units over the next 12 to 18 months, that will result in 25% reduction in our cost. When we double again, and you can see in the horizon, that would be entirely in our expectation, that will lower our cost another 12.5%. That's one thing. That is, of course, going to push us strongly into the high 80s or allow us to maintain it should we enter international markets and have a lower out-average selling price.
The second, and not insignificant, is how this RECELL GO is going to transform our cost of packaging and shipping. We've eliminated cold chain packaging. We used to have to ship in a temperature-controlled package, which we're no longer required to do, which lessens the waste that we have in our packaging and shipping, and that's a big deal. Secondly, the RECELL GO cassette, which is a disposable, will come in a kit that's approximately 70% smaller than the current package we currently ship and the ease of use. That, again, reduces all of our packaging materials, and we've gone through recyclable almost fully in terms of those types of packaging materials. That lowers the cost. It also helps us be much more environmentally friendly and really help work towards our company ESG goals.
In the RECELL GO, the RECELL GO cassette is made of recyclable material. Really, we're able to do both here. We're able to reduce costs fundamentally through volume because of our large fixed overhead, relative to our that is going to be stable. We're also able to reduce our packaging material, which has double benefit. It lowers cost, and it contributes to less waste into the environment. In the design of the cassette, going to a recyclable material also makes it environmentally friendly, and it's lower cost, as it turns out. I think our gross margin is really in a good place. I think our internal ESG and initiatives are really come to fruition during the next one to two years.
Okay. Jim, our next question is, Japan revenue for Q1 increased to over $1 million. Are you able to provide reasons for the increase, and how should we be looking at it in the future?
I can. Now, we're in a good place with COSMOTEC, but one of the dynamics of the Japanese market is that from a legal sale point of view, let's keep that simple. We sell to them. When we do that's our recognized sale. In their case, they recognize the sale upon use because in their sales model, they keep inventory at the hospital, but they own it. What you saw in first quarter was an expansion of accounts they were opening and them building inventory to support that advancement. I mean, that increase in new accounts. I think we wouldn't expect that $1 million to be the standard each quarter. Actually, that is an inventory expansion to accommodate the business model in Japan.
We do expect good, strong quarterly utilization in Japan, which we're experiencing, and we'll be reporting replenishment of that inventory on a go-forward basis. There was a defined number of hospitals that treat burn patients in Japan, and COSMOTEC is in a substantial majority of them. We won't see that big of an expansion of their inventory position, I think anytime soon. I think we'll see replenishment.
This question's on Japan as well. When can we expect updates on Japan timelines for soft tissue, vitiligo, and RECELL GO?
Yeah. Go ahead.
There's a second part I'll ask you after that.
Okay. We are in conversation with COSMOTEC about that very, very issue. We're reaching a new, so to speak, business agreement and business process with them as both companies are getting more active commercially. There's more things happening where in this case, they need to submit for expanded indication for soft tissue, and they need to submit for vitiligo expansion on that same indication. We wanted to send them. The Japanese PMDA wants fully adjudicated data, so to speak, which means we wanted to wait until we got through the FDA process, where the FDA reviewed our data, found it to be acceptable and consistent and no follow-up items that are outstanding, all those sorts of things.
We have a deliverable over the next 30 days to deliver them both packages of data. They have a deliverable within a short time afterwards to project a submission date. I believe I should be in a position to project a submission date by our next quarterly conference call. When I can do that, we will be able to project approval and launch date in Japan for those two indications. RECELL GO, part of our development program was to develop the testing protocol so that we could submit it to PMDA. We also wanted to develop that design of RECELL GO such that it passed the electrical standards of the European MDR, which covers European countries, and later this year will cover Australia, and the U.S., of course. We are doing the testing that is required for the Japan submission.
Sometime in Q4, when we have final inventory, which we'll be building for the US launch, we'll be sending them our test data along with some test units for them to test against some Japanese standards that are better performed by them, and we'll get a submission date for RECELL GO. All of that is in process. I think there's a good future, a really great future in the longer term for Japan, very solid in the burns indication the next two years. I don't have an estimate yet on submission date and submission approval, but I will. I think by the next conference call, they will have had time to consume the data, create a submission plan, and we'll have that calendar.
Perfect. Thanks. You actually answered the second part of the question in that, That's good. The next question I have is in regards to RECELL GO. When will it be fully integrated into the sales and implemented?
Well, presuming that everything goes as we plan, first thing we planned is June 30th. June 30th sounds like a date. What it really was, an extraordinary effort by our whole regulatory quality manufacturing product development program management team to develop the product, get it tested, and have it validated that it could disaggregate that tissue consistent as it is currently done. It sounds like a date. It's an extraordinary performance by our team over the last six months. Now we're moving to manufacturing and supply chain, commercial launch type topics. I can tell you rather simply, and I'll have greater detail by the time of our next call, our current intent is to have production inventory in place at the time of approval.
It'll be our objective that during 2024, we convert our U.S. supply completely to the RECELL GO kit. That means that we want to help our customers adopt the RECELL GO device as quickly as possible, and we will remove any possible barrier I can think of to enable that. Because we know adoption of RECELL GO will mean more patients get treated who need it. We know that the hospital staff will benefit from RECELL GO by not having to get trained and retrained as their staff transitions. We know we will get better sales productivity from our team who don't have to day-to-day perform as much manual training. We know that this is a transformative technology, so our objective will be to launch it as quickly as possible. In international markets in 24, we will only launch RECELL GO. We will not launch the existing RECELL.
Perfect. Thanks. The next question is, can you provide a brief summary about the two new board members and what value they will add to the company?
Well, I can. First of all, Bob McNamara is a career CFO professional. You can look at his past, and he has been CFO of multiple companies, public and private. He's got extensive experience as an audit chair. When we did our search, we explicitly were looking for an individual with Bob's experience and know-how and his ability to help us frame, not just our audit committee, but help us with all the related functions that are derivative of having a financial executive of his acumen. That's what he brings. At the same time, we were looking also for a commercial executive, Cary Vance is a multiple-time CEO and of public and private companies. What that brings to our board is that experience.
A CEO, you have to deal with so many different issues that balancing the priorities, building the culture of our company, Cary is going to be very helpful with that in a short time. He and I have talked about that quite a lot because what drives company success is our people and our culture and our focus on execution and the esprit de corps that gets created by that treating of the patient and the success that comes from doing a great job for the patient. Cary really helps us think about that and will help contribute to the board in that type of way, I'm sure among others.
The next question is, can you confirm that the Q1 expenses don't push back the estimated Q1 2025 profitability, excluding international vitiligo launches?
I can confirm that. In fact, there's two elements to that. If, for example, we had hired slowly and we were not ready when soft tissue repair comes, we would actually burn more cash ramping up the team to take advantage of that opportunity. This is actually over the longer horizon of two or three years, the less use of cash. Remembering that we look at an individual salesperson or field team because that includes our Clinical Specialists, because they're vital to our strategy in support of a customer, and they are commissioned as well. They're a different part of our sales model. Having them productive on day one, five kits per month gives us a contribution margin breakeven for each one of them.
If for each one of them, when they get to five a month, we're into contribution margin positive. The being ready really contributes to that Q1 2025 cash flow crossover. Now, one thing we left, which I'm confirming, is when we gave that guidance prior, we would cross over. We have approximately $30 million in reserve at that time. And again, that is subject to what we do with the vitiligo channel internally or externally and any other unknown investment we might consider between now and that time.
The next question is, with the added sales team members, what is your projected cash burn rate for Q2, three and four, if you're able to address it on the call?
I think right now we have not guided to that. You can see and estimate in our financials that we've disclosed what our cost position is. We're not substantially changing what we're investing over time. We had some one-time costs in Q1 that are not relevant to the forward extrapolation. We also started the sales hiring, and we're able to do it faster and earlier, and that pushed Q2 up a little bit. We still think Q3 is the peak ratio of expense to revenue, and it will begin declining after that. The logical question is, you know, how long does it take for a rep to get to five per month? The answer is, we have experience with that, with the burns indication.
It was harder then than will be now, because at that time we were a completely new product going into all new accounts with very little commercial proof. We now have thousands of patients that have been treated by RECELL. We have hundreds of physicians who have used it. We have been, you know, we have a lot to work with. That crossover is a months question, not a year question. It does have some variability. We see Q3 as the peak and quarter by quarter that will improve.
The next question is the full year 2023 revenue guidance $49 million-$51 million, is it inclusive of potential sales in the soft tissue indication in Q3 and Q4?
It is. Absolutely is inclusive of that e-expansion.
The next question is, how should we think about some of the recent departures of key executives over the last nine months?
Well, there's been three. Two of them were the company's choice in terms of wanting to structure the company differently. That was a decision of skill set and company structure. In the recent departure of Erin Liberto, Chief Commercial Officer, two things. There's two things to say about it. First of all, she received an offer to go have a substantial position in a company in a whole another field. It's a really, it's confidential at the moment, but really exciting opportunity for her. At the same time, what she has done in an extraordinarily well, good, strong way, is she built a really strong commercial team.
When she came to me and said, "Look, Jim, I want to do this," I said, "Well, let's talk about that." You know, we talked about her staying or, you know, she says, "This is the kind of opportunity I've been looking for, you know, for a long time. I really want to have this type of role." Which I understand. That's a, you know, she's been with us five years. She built our commercial team. Two of the executives she built and kind of nurtured their development are the two executives who recently assumed tremendously more responsibility, and that's Terry Bromley, who's now VP of Global Sales. Given our international ambitions, our vitiligo challenge strategy, that's a substantially larger role. The same can be said for Debbie Garner in terms of Global Vice President of Marketing and Strategy.
Both of them are very seasoned executives, very competent and well prepared for their role. I'm looking, you know, on one hand we are happy for Erin. We wouldn't have chosen for her leave necessarily. That's for sure. Having said that, what we have are really two great executives to step into her role. In anticipation, they'll both be reporting to me. We do not intend to replace the Chief Commercial Officer role because I'm very confident that working with Terry and Debbie, we can accomplish what needs to be accomplished for AVITA.
Okay. The next question is, does RECELL restore the same skin color of patient as before the incident? Should the autologous source be of the same skin color as that of the patient?
You're asking if the autologous sample produces the same pigment when used on another part of the body? The simple answer is yes. It has not been explicitly studied, but our experience is that it does.
Okay. Next question is, the company is confident about the PMA approval for soft tissue repair. What will give you the confidence given the original clinical trial showed non-inferiority for healing, but only updated analysis showed non-inferiority?
Yes. You're correct. That's a statistical definition. Originally, the endpoint for the P-value of the tails for the soft tissue repair clinical results was to achieve 0.025 in the tails, which is a 95% non-inferiority statement. The actual results were 0.010. By definition, we achieved the endpoint, but in fact, statistically slightly better. We feel quite comfortable and good about that outcome.
The next question is, the company was started in Australia. Do you plan on expanding in Australia in the future?
The simple answer to that is yes. One of the things we've been doing is we knew that we had to expand with RECELL GO, and we knew that we had to have a regulatory readiness for Australia. That'll all be in place by the end of this year. We are looking to have a partner in Australia. That process of vetting and identifying that partner is just beginning, but we plan to have it in place in early 2024, when coincident with the use of the MDR, which is the CE mark equivalent, will be utilized by Australia, and we'll be able to leverage that regulatory approval for RECELL GO in the Australian market.
We're quite looking forward to reentering the Australian market along with some other international markets, but Australia happens to be one of our priorities. I have a meeting about it, in fact, tomorrow. We're beginning our process now.
Perfect. Thanks. The next question is in regards to EPS. The EPS reported for Q1, should we think of this being somewhat atypical? Perhaps it's largely attributed to unusual expenses such as severance payouts or executive payouts and/or salesperson expansion.
Well, certainly, there were some one-time charges there, and those would not be a go-forward e-expectation. Secondly, the sales force expansion being ahead is, in fact, reflective of our cost structure in Q3, that we would expect to be at a peak revenue to expense ratio. You can use that to make your estimates by that being your peak and the cost structure is rather known. We'll exit Q2. When we report Q2, our expenses will be principally embedded. Therefore, in Q3, as we are at that peak and we are executing our revenue expansion, you should expect improvement and on a continuous quarter-to-quarter basis, if that's helpful.
At a current run rate of $42 million a year for the burns indication alone and your guidance of $49 million-$51 million, how should we think about soft tissue in Q3, Q4? Is it a slow ramp or a quick ramp?
Well, launching soft tissue early is going to help us. It's going to help us have a faster ramp than we would otherwise have anticipated on the one hand. Secondly, we will be able to promote soft tissue immediately within Q2 in this half of the hospitals that are the burn center, so 70+ hospitals. At the same time, we're subject to the variability of hospitals going through their Value Analysis Committees and approving the product and getting the first cases accomplished. That is a, is a rather unpredictable process which will bring some predictability. For example, at the end of Q3, I'll have data on how fast we're getting through VAC and how quickly we're adding new accounts.
We clearly have some expectations for that, but there is some variables there that will be a market experience because we're going to a broader set of indications, a different call point in trauma surgeons. Those variables will play out. We think we've got it estimated very well. You may note, I share with the team, our goal with guidance is to be credible. That is that if in the first quarter, for example, we know it's bad to miss guidance low, that's obvious. If we're consistently missing it high and overperforming our guidance, investors won't have confidence in our guidance. You know, they'll not know what to expect.
That will result potentially in external parties you know, increasing, their forward expectations ahead of ours because ours aren't credible. Our goal is to be credible. We think right now that our guidance is right where it needs to be.
Okay. The next question I have is in regards to earnings per share. Your Q1, you had great results. You were right in line with consensus. However, the stock price declined. Is there anything that you can share with us why it potentially dropped?
The simple answer is no. One of the benefits of the ASX continuous disclosure requirements is if I know something that would affect share price, I'm required to disclose it immediately. Of course, we would. I don't have an explicit reason. Stocks, especially in our mid, you know, micro-cap, mid to mid-cap category, sometimes are subject to events that we can't see that are transitory. I suspect since there's nothing actually happening, that this is transitory because of that. I wish I knew exactly, but I have a lot of confidence in our business plan. We had a tremendous first quarter. We actually delivered on every one of our commitments and our guidance. In fact, we're ahead on many of the key milestones.
We feel terrific about how the company is. Fortunately, short run, we're in terrific shape. We have the capital, we have the approvals coming, we have the team in place, most of all. The team that we've recruited are simply awesome. I've interacted personally with every one of them. The 40 new people who have joined our team, are gonna really make a big difference for us. The approvals are gonna make a big difference for us. We're investing in the strategic long term of our manufacturing facility because I asked our VP of manufacturing to do is I said, "I need to understand the path to a 10x increase in volume. I wanna make sure that we are secure in this location for a long, long time." The reason is moving it is hard.
From a regulatory point of view, it's very complex, it's very distracting, and runs risks. We have a wonderful manufacturing operation that's efficient. We ship on time virtually 100% of the time. On time is order today, ship today. Virtually 100%. We have an 83% gross profit, right? The more we expand this company's ability to treat patients, RECELL GO as another example, these are the drivers of the company. When I think about that short term happening the last couple days on the two indices, I see it in the big picture view. I see it from the right altitude. You know, if my altitude is too low, I'll wrap myself around little whoops like that and won't spend my time productively.
My productive time is working with the team to make all this come about.
I've got one or two last questions. One is, you recently filed, with the SEC, what is the $200 million capital raise about?
Well, simply there isn't a $200 million capital raise. What we filed is referred to as a shelf offering, we had one existing before this one. Companies most commonly keep a shelf offering of authorized shares in the event that they have a reason they need to use them to raise capital or do an acquisition or do something. They are unallocated shares. They're not in the EPS calculation. They simply exist as approved shares. That shelf offering is what we filed because it's good for three years. Ours was going to expire here in the next several months, and we were simply putting it back in place. No offering is existing, we're just structuring our company to be flexible.
Great. The last question I have for you, Jim, is, are you seeing more hospitals, including RECELL as part of their standard of care like LSU Health?
Well, the simple answer is yes. We haven't had material new accounts for multiple quarters, for at least three. We might get one or so because we're in almost all the burn centers. All of our growth the last three quarters has been same store sales, and that is a reflection of adoption. We see adoption continuing to increase. My outlook for the burn market, for example, is we're gonna get our share of those 10,000 over the next several quarters that we haven't been calling on. That's 30% of the burn market. I think our data continues to grow.
In fact, you know, the American Burn Association conference happens to be this week in Dallas, and we continue to have an extraordinary presence scientifically that I might get this precisely wrong, but it's approximately right. I know there were seven different studies presented, four of them from the podium and three posters or the other way around. I don't have it right at my tips. The fact of the matter is those are all physician in-initiated. They're not reflective of our company efforts. They're the independent efforts of physicians who see the promise and their experience with RECELL as being relevant and appropriate to share with the medical community. It is a process of developing a best, you know, kind of standard of care, and we continue to show all the right signs.
Perfect. Thanks, Jim. With that, I'll turn it over to Jim to close. Sorry, Rudi to close up the meeting.
I don't know, Jim, will you close?
I can. First, let me express my appreciation to all of you for joining the call today. Thank you very much. I appreciate your interest in AVITA. Of course, we trade here on the ASX with AVH and on NASDAQ, RCEL. We appreciate your interest. Your questions are welcome. We have investor relations that you can submit some questions if you want to engage the company on a topic. I encourage you to do so. I look forward to my next visit to Australia, which I can tell you is Monday, August 15th. I will be here. I'll be in Sydney, actually, those two days, and I'll be in Melbourne Wednesday and Thursday that month, on that quarter.
In my travels, I look forward to hearing from you, and I appreciate your interest.