Ladies and gentlemen, thank you for standing by. And welcome to the AVITA Medical Second Quarter Earnings Conference Call. [Operator Instructions] Please be advised that today's conference maybe record. I'd now like to hand the conference over to your speaker today, Ms. Caroline Corner with Westwicke. Please go ahead ma'am.

Thank you, operator. Welcome to AVITA Medical's first fiscal second quarter 2021 earnings call. Joining me on today's call are Mike Perry, President and Chief Executive Officer; and Sean Ekins, Interim, Principal Financial Officer and Principal Accounting Officer. This call will include forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements made on this call that do not relate to matters of historical fact should be considered forward-looking statements, including statements regarding the markets in which AVITA operates, trends and expectations for AVITA's products and technology, trends and demand for AVITA's products, AVITA's expected financial performance, expenses and position in the market and the impact of COVID-19 on AVITA's operations and AVITA's customers' operations. These statements are neither promises nor guarantees and involve known and unknown risks and uncertainties that could cause actual results, performance or achievements to differ materially from any results, performance, or achievements expressed or implied by the forward-looking statements. Please review AVITA's most recent filings with the SEC, particularly the risk factors described in AVITA's S-3 and 10-K filing, and in AVITA's quarterly report on Form 10-Q for the second quarter ended December 31, 2020 for additional information. Any forward-looking statements provided during this call, including projections for future performance are based on management's expectations as of today. AVITA undertake no obligation to update these statements except those required by applicable law. AVITA's press release for the second quarter of 2021 results is available on AVITA's website, www.avitamedical.com under the Investor Section and includes additional details about AVITA's financial results. AVITA's website also has the latest SEC filings, which you are encouraged to review. A recording of today's call will be available on AVITA's website by 5:00 PM Pacific Time today. Now, I would like to turn the call over to Mike for his comments on second quarter 2021 business highlights.

Thank you, Caroline, and thank you everyone for joining us today. The second fiscal quarter ended December 2020 was a solid quarter of execution here at AVITA with progress across several of our growth drivers. While we pre released our top line results and a few metrics in January, I'm pleased to be able to provide you with some additional details and updates today. Before I delve into our recent performance, I realize that many of you listening today may be somewhat new to AVITA Medical. So I'd like to quickly provide some background on our business and on our technology platform. AVITA is a commercial stage regenerative medicine company with a proprietary technology platform that utilizes the body's own healing powers to provide skin restoration at the point of care. In simple terms our offering which is known as the RECELL system is best portrayed as Spray-On Skin cells. Clinicians take a small sample of the patient's skin and within 25 to 30 minutes can utilize the RECELL system to prepare an autologous cellular suspension, which is then sprayed onto the wound or defect to regenerate natural healthy epidermis skin, including the return of natural pigmentation. Before RECELL received FDA approval in late 2018, burn patients received large skin grafts from other parts of their bodies, which created large secondary wounds that were extraordinarily painful and provided new sites for potential infection and scarring. Today, the RECELL system delivers compelling well defined clinical benefits by significantly reducing the amount of donor skin required to treat to second and third degree burns and genuinely provides win-win dynamics to physicians, patients, hospitals and payers. RECELL was the first PMA approved in burn care in more than 20 years. And we began our commercialization efforts within the hospital inpatient setting in early…

Thank you, Mike. For the second quarter that ended December 31, we reported revenues of $5.1 million, compared to $3.3 million in the corresponding period ending December 31, 2019 and flat to the prior quarter ending September 30, 2020. As Mike mentioned, the flatness in the current quarter compared to the prior quarter was largely driven by the spike at COVID-19. The gross profit for the December quarter was $4.3 million, representing a gross margin of 84%. This is an increase of $1.9 million from the gross profit of $2.4 million or gross margin of 74% reported in September 2019 quarter. Increase in gross margin is largely driven by our increased shelf life, along with reduced shipping cost and increased production at our inter facility. The total operating expenses for the December quarter were $10.4 million, which is a decrease of $3 million compared to the same period in 2019. The decrease in our operating expenses is primarily driven by the reduction of our share based compensation, partially offset by the increase in our research and development costs. The reduction in our share based compensation is related to the reversal of unvested incentive compensation for an executive that's separate from the company prior to fully vesting. The increase in our research and development costs was attributable to ramping up our clinical trials for treatment of vitiligo and pediatric scald and other research and development costs associated with furthering the company's pipeline. Cash on the balance sheet was approximately $59.8 million as of December 31st, 2020. With that, we thank you for your attention. And now I will turn the call back over to the operator for your questions.

[Operator Instructions] Our first question comes from the line of Josh Jennings with Cowen.

Hi, good afternoon. Thanks for taking the questions and appreciate all the details provided on the call. I think this setup in terms of what you're experiencing currently with COVID was is well documented. Now I wanted to ask a couple questions on the vitiligo. I see vitiligo indications are deeper we dig into it, the more enthusiastic we get. I wanted to just get your sense of some of the precedent data that's out there for RECELL in stable vitiligo. Like people are aware of the China data that's accrued the real world experience and then you have the not so often US but more so internationally employed Melanocyte-keratinocyte transplant procedure. And we've dug up some pretty impressive results in terms of repigmentation efficacy for that procedure. And would you consider that as strong precedent in terms of how you're thinking about the potential for the data in the US pivotal trial, and how strong is that efficacy data for MKTP?

Thanks, Josh, for your question. The data on MKTP Melanocyte-keratinocyte transplantation is very strong. But as there are only a few centers in the US. And it's a very costly procedure so not really scalable. At the same time what that procedure does is transfer skin along with Melanocyte and keratinocyte from an area of the patient's skin that is pigmented and moves it to the area that is deep pigmented due to the active vitiligo or stable vitiligo. Hopefully, at the time of treatment, I think it serves as an excellent precedent, in addition to our 1,000 patients that we have treated with the RECELL system for their vitiligo disease previously, in that it's the same transfer of Melanocyte, specifically, from an area of pigmentation to an area of stable depigmentation of the patient and prove that process works for repigmentation and is a durable effect. So I think very much yes, that serves as a wonderful precedent, and gives us a lot of confidence in our trial going forward. That said we're not sure of the exact concentration. So in our clinical trial, we have three groups that are trading at 1 to 5, 1 to 10, and 1 to 20, when our regular product that we have for burns for reepithelialization is at 1 to 80. And while that will return pigment within 10 months to a year, the goal of course in burns is reepithelialization, whereas the goal in vitiligo is repigmentation. Hopefully that answered your question. Please let me know if you have any follow on.

Yes, thank you just a couple real quick ones on the vitiligo. Additionally, just I mean, if you talked about the three different expansion ratios that are being studied in a pivotal trial in the United States, and we'll see what that shows, but I mean, one way that we're thinking about is that AVITA have three shots on goal here and I mean you have three different expansion ratios ongoing. And you could have all three of them be success; we could have all two of the three, or one of the three. I mean is that the right way to think about the trial design? And that there are actually three different expansion ratios that are being said here. So it's three shots on goal for efficacy?

Yes, it is the correct way to look at it, relative to the efficacy endpoint that we've agreed to with the FDA. At the same time, we've got a lot of experience ex-US on the 1 to 20 ratio, which does successfully repigment but we wanted to make sure that when, as you said, we've got three shots on goal, to hit our primary endpoint, we've got an interim analysis. And that would be a possibility where we drop a group because we're seeing strong efficacy in other groups. I think that's it there. Andy is there anything you might like to add to, Andy is our Chief Technology Officer, to that relative to the vitiligo clinical trial.

We undertook a feasibility trial to look at these different concentrations. And we're continuing that work as a way to get an early signal at what differences we might see in the pivotal work. We proceeded with a pivotal work because we came to understand with Medical Advisory input, that in fact, part of the patient physician conversation is around the trade off between how much donors can you want to harvest and likelihood of success? So what we anticipate is some differences between those study arms with respect to response rate. And so that is why we have them, and why we proceeded with a pivotal study.

Thanks Andy. Maybe if I could just throw one last one in. On vitiligo, you mentioned the feasibility trial. And I wanted to ask when we could possibly see results of the feasibility trial or will they be made public in 2021, and any update on the enrollment status there. And on top of that, just any other publications, either the experience in China or the resale experience in vitiligo in the Netherlands, that could be coming into print in 2021 before we see the top line data for the US pivotal trial. Thanks so much for taking the questions.

Thanks, Josh. I'll pass that question over to Andy as well as he's got the more of the detail on the specifics of0 the trial as well as other precedents.

The feasibility trial is halfway enrolled; we've 5 of 10 subjects treated. We will be looking at their data after three months of follow up and again at six months. So roughly three months from now is when we'll start to see those patients in that first group coming in and we'll make we'll be conducting analysis and figuring out what it means for us in terms of next steps at that point. The latest work from our collaboration with the Netherlands Institute for pigment disorders, is about to be submitted for publication. And the study that they've most recently conducted really points to the importance of stability in this population before proceeding with a surgical intervention.

Our next question comes from the line of Kevin DeGeeter with Oppenheimer.

Hey, guys, good afternoon, and can you maybe talk us through the underlying assumptions with regard to TPT code, you mentioned the hope to begin to have some discussions with payers late in 2021. I guess really sort of two questions here. Any additional color you can provide and kind of the most latest communication on that application, and then point two to kind of hit the timeline for contribution beginning later in 2021. Can you kind of just kind walk us backwards as to what that suggests is to a timeframe for having some clarity on whether that code will be issued or not.

Sure, thanks for the question, Kevin. So we were actually we started off with an NTAP. So basically an add on payment. And we were specifically directed by CMS to go through the TPT, the transitional pass through payment. And we remained very confident that ultimately we'll get it. So that part of the question, I think CMS is delayed due to COVID, we have no reason to believe that there's anything in the application that's being questioned. And they're for products that have breakthrough therapies such as the RECELL system; they're looking at the applications on a quarterly basis. So the next quarter, April 1 of this year, hopefully, we'll see the C code coming through relative to launching in the outpatient setting, and what that will look like, I'd like to pass it over to Erin, our Chief Commercial Officer to give you a little bit of color on that.

Thanks Mike. Hi, Kevin. So there's a few things once we get the code really, that's just Medicare, Medicaid that it's covering, right, which is less than 15% of the patients in the hospital. And so we need to make sure that we've got commercial payers on board and that they're covering it, paying for it and not rejecting it before we want to make a full run at the market. So we're actually going to be planning on doing once we get the code, doing a pilot launch at about a six centers, and working with them to get some code -- to get some procedures and ensure that those codes or those procedures are getting paid, once we're confident that that there's good coverage, and then we'll be rolling it out to kind of a broader number of accounts. But as you can imagine, it does take a little bit of time for the procedure to happen for then it to be submitted and then just see if there's a denial and to work through that. So that's kind of how where those timelines are coming from.

Great, as you think about the process of establishing those interactions with payers in the outpatient setting for the burn market, that timeline is a bit out in front of the prospective launch for vitiligo but they're not terribly out in front of it, do you see opportunities to from the education perspective to begin to have a dialogue with payers on the vitiligo indication as part of the outpatient burn discussion or is this -- is a pragmatic or a logistics question are those really kind of full wholly separate discussions and timelines.

They will be separate predominantly. So this will be covered in the outpatient setting or ambulatory surgical setting, vitiligo for the most part will be done in the derms office. So we're going to have to pursue a different reimbursement strategy to get that covered. Now, having said that, if that derms wanted to go and treat it in the outpatient or an ambulatory surgical center, then they could leverage that code. The code is not kind of indication specific. But the majority of cases won't be treated there. They're going to be different point of care.

Our next question comes from a line of Ryan Zimmerman with BTIG.

Thank you for taking the questions. Appreciate all the color, maybe, on the accounts, the 20 burn accounts that you refer to Mike, can you just talk about kind of the utilization within those accounts given that they are strong users of the technology and kind of what kind capacities you have in those accounts specifically, and then maybe the dynamics within the other 73 accounts or so how -- what and how you see utilization trending with those accounts absent these COVID dynamics?

Sure. Thanks for your question, Ryan. Relative to the, I'm going to start off and then pass it over to Erin again for a little bit more color. But at the top line of those 20 accounts that we might call are super users. There definitely have a couple of surgeons that are looking at RECELL as we look at RECELL inside the company, which is any burn, that is requiring a skin graft, whether the deep partial thickness or full thickness, second or third degree burns, that RECELL has a role for application and for the indication and is going to be better than the standard of care for the patients. So, they're looking at RECELL whenever they're thinking about skin grafting. And the other accounts it's the adoption curve. And they're just basically looking at timing; we're looking at their timing and their experience to get comfortable with use of the RECELL system. Typically, they'll start with large burns that are deep over 30%, full thickness because they can use it along with a widely mesh split thickness skin graft where they're comfortable. And then they start moving down to smaller wounds, and then ultimately to smaller and deep partial thickness wounds where they can use RECELL alone. For a little bit more of the dynamics. I'm now going to add a little bit more color. I'm going to pass it over to Erin.

Thank you, Mike. Hi, Ryan. So just to kind of put it in perspective, I think we've got some accounts and we're managing or we're measuring penetration in terms of usage, RECELL usage, in terms of total admin rights, total admissions, burn patient admissions. And so we have some accounts that are using RECELL over 30%, over 40% of all admits or RECELL being used on now, when in our internal modeling, when we look at peak, that is not what we think is going to be normal, right. So that is really using RECELL on everything using RECELL on very small wounds RECELL on faces on children and first line therapy. I mean, they're using it consistently, right. So we don't think that's where the bulk of the market will be. If you look at kind of where we're at for all of our customers that are approved through the value analysis committee, they average last year about 8% of total admissions. So if you average for all our customers were about 8%. But it just shows you that there really is opportunity to kind of really get up to the 13% -14%. Although when I look at that I don't think that's going to be the normal for everyone. But that certainly shows the opportunity that there is for us.

Yes, that was great, Mike and Erin, thank you. Maybe turning the vitiligo for a second following up on Josh's questions earlier, just you put a stake in the sand around enrollment completion by the end of FY21. And I wonder if you could just speak to your confidence in the sites that you're brought up online? You're at 11 today, kind of what are you seeing specifically that gives you that confidence to get that trial completed and done by the end of the fiscal year 2021? Excuse me in calendar year 2021?

Yes, so thanks, Ryan. Yes, and so far as looking at the end of the calendar year, the cadence and I would say, really, the enthusiasm that we're seeing from both physicians and patients is driving our optimism relative to enrollment. Also another factor relative to enrollment before I pass it over to Andy, to give a little bit more color is that we're not competing directly with COVID beds, of course, these are procedures that are not in the ICU. They're outside of the hospital setting often with the procedural dermatologists, and plastic surgeons. So that helps give us the confidence that we will complete enrollment by the end of this calendar year. And Ryan, I'll now pass it over to Andy Quick, our CTO.

Thanks Mike. Hi, Ryan. The vitiligo program as already discussed is receiving a lot of attention within the community. There is a lot of excitement. We are engaging with the community through advocacy sites, through local radio, through social media platforms, with a concerted effort really to drive those patients to the door. It's sort of known within the vitiligo community that there aren't great treatment options. And so we need to be a part of creating that awareness and bringing patients to the door. That's why we think that we'll be able to recruit this year is by taking that active role involving recruitment.

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

Thank you. Good afternoon. I want to follow up on Ryan's question. I'm curious, maybe Erin could just help us to understand what you're trying to do to take the 20 accounts to the 93 accounts to the 136 accounts, and whether you think there's realistic possibility that they can begin to happen in 2021.

Sure, hi, Brooks, good to hear from you. So I think that first and foremost, I think as COVID lightens up, and we're able to actually sell and get into the accounts, that will be the most influential thing that we can do. But I think the second to that is all about education, training, and specifically peer to peer kind of communication, dialogue, exchange, and training. So we're putting a lot of effort into connecting, we've got over a dozen kale KOLs that we've contracted to help us with training, and we're doing tailored individualized training for accounts. So we're not leading the training, we're connecting the surgeon, we're saying perhaps what the hurdle is, or where the challenges are, where they're at in the adoption curve, and then that surgeons able to share their own experience their cases, and they have a private one on one dialogue, where they can really kind of speak together and share experiences. And we're finding that that almost always leads to a case, usually within the following week. So that's very impactful. We're doing we're investing heavily, we're about to roll out some virtual reality modules as well. It's really important just to keep the content fresh, to be ever pivoting. And just to have something new all the time is just getting stale, all these zoom calls and the same old. So really, it's going to be education and these different modes of education until we can really get out there and sell and then we'll continue with the education, but the supplementing with the being able to kind of get in there will certainly help.

Great. Thanks. Erin, I had just one follow up. I was curious. Obviously, it's been a challenging environment for everybody sounds like perhaps particularly challenging in the burn environment that you guys face? How's morale? First in the sales organization? And secondly really throughout the entire organization? And would you say it had an impact on your people? Or do you feel like people are sort of hunkering down and ready to get going again, as soon as the doors open?

Thanks, Brooks, I'll take that one. And I may pass over to Erin for specifically on the sales group, but in general, for the company, I think we're seeing a very strong level of engagement through COVID, as a matter of fact, sometimes, because people are working from home they are actually working longer hours than they would if they were in the office. And it's been a very, it's challenging, again, because we're not in person. And of course, communication is always best in person, but using the various platforms that are available for us for video calls. We've been really keeping employees engaged. We've also had a variety of employee engagement opportunities, that has been -- that have been led by HR, where we're doing some fun things with the employees over the zoom platform, and making sure that our employees remain engaged and understand that at some time, in the future, hopefully near future, when we've got a good proportion of our base, employee base, vaccinated will be able to have a return to the office and but overall very, very a positive on how employees continue to engage during these trying times. I'm going to pass it over to Erin for specifically on the salesforce because they've got some different challenges that COVID presents to them relative to access to the hospitals to burn centers, and expanding and actually just making even making contact. Erin?

Yes, absolutely. So it's challenging, right. And at times, it's certainly frustrating when you can't get in there sale even all the selling opportunities are kind of diminishing, including just regional conferences, right, that are now virtual are being canceled. So there is, I don't want to lie that there is some frustration, but I think that's in many different industries. And I think if anything, our reps are feeling grateful and supported. We've altered the compensation plans clearly. I don't want to say that everyone's hitting the comp targets, 100%. But we're certainly being reasonable and making adaptations to support them. We're also creating sales contests and circles of excellence and variety of different things, right. So that they can have various shots on goal. Their comp plans aren't 100% commission based, they also have a base components. They also have components based on other activities that aren't necessarily sales driven. So we're trying to kind of broaden that a little bit, but in general, I think they're feeling supported and the feedback I'm getting is AVITA one of their favorite companies to work for, they think is a great company and good technology. There's a lot of turnover in the hospitals right now, or not the usual folks that they're dealing with. So they are feeling the strains of training and that remote training, but they're traveling less than so. So I think, in general, we're feeling good. We're not seeing turnover anything kind of concerning from that perspective. So I think we're in a good place.

Yes, I'd like to add, Brooks, that I felt too remiss, I fail to mention, our Ventura facility where we do our manufacturing, and those employees been coming to work on a daily basis, and continuing to manufacture product and continue supply, both for clinical trials, as well as for use in the field. And morale there continues to be good, and they're performing an excellent job. And knock wood everything has been going well, we've seen no interruptions in our supply chain through this entire period.

Our next question comes from the line of Lyanne Harrison with Bank of America.

Thank you. Good morning or good evening. Mike, you mentioned when you were talking about growth drivers, you talked about expansion to markets outside of the United States. You mentioned Japan, can you also provide a little bit more color in terms of what other countries are you considering? And what sort of timeline would that be?

Sure, thanks, Lyanne, for your question. What we're really looking at is right now with just burns. When we do -- when we looked at the economics, for burns alone, it ends up being a negative ROI for the business going to Europe, Australia, both due to reduced incidence of burns in those areas and regions, as well as the work that would be required as well as the spend that will be required to do local clinical trials get reimbursement in each of the countries in Europe, for example. So what we're really looking for is our pipeline to expand new indications to come on board such as vitiligo and trauma soft tissue. And then we'll be looking at an expansion back into beyond Japan, back into Europe, back into Australia, and other areas of Asia.

Thank you. Just an indication it's probably not going to be in the next three years. Probably Japan.

Other than Japan I would say, three years is probably the pivot point at which we will start looking at re-launching.

Okay, thank you. And then also in terms of these growth initiatives ahead, obviously you talked about the Japan market in the work you're doing there and also progressive clinical trials. I'm just trying to understand in terms of cash balance, do you think that provides you with adequate funding to progress these initiatives or would be that consider a capital raise.

So, regarding Japan, we would definitely be getting into revenues from them once they're approved. As soon as PMDA approves the product, it goes to MHLW, the Ministry of Health, Labor and Welfare; they will be setting the reimbursement price. And then COSMOTEC, our partner there is ready with their direct sales force to do a launch economics there are about 50:50, relative to the split of revenues. Regarding funding the pipeline we did end the year with about $60 million of cash. We are burning somewhere between $6 million to $8 million per quarter. And we also anticipate revenue accrued from our burn business will continue to fuel our pipeline. Other than that and so far as raising cash, we're going to be opportunistic, regarding potential opportunity.

Okay, thank you very much. And I guess just one final question, if we come back to the COVID impact on your burns business and on the number of procedures that the volumes of procedures that was down for the second quarter of 2021. Can you give us some color on how that trended by month by month? And also, I guess you mentioned that January was the softest sales you've seen since the pandemic began. But do you have a sense of procedures with procedures down as well? Or did you keep procedures start to recover, given the number of COVID cases has started to reduce this month?

Thanks, Lyanne. We have not given guidance in general or provided numbers, specifically on our month to month revenue. And we've given a little bit of historical reference relative to procedural growth. I'm going to pass it over to Erin in a moment. But yes, January was the softest that we've seen since the pandemic began. But it was also, as I mentioned, in my prepared remarks, partly due to loading of accounts in December, and the reason that that happens is to reach rebate levels, there's various tiers. So various centers or hospitals will buy up to a million dollars or different grades and levels. So they'll get different tiers of discount. So working through that inventory, brought our use of RECELL down, to speak to procedures and our recovery that we've recently seen in February, we'd like to turn it over to Erin Liberto, Chief Commercial Officer.

So maybe the only the thing that a committee adds some flavor, right. So there was we do believe there was loading because the rebate also was the end of the compensation period. And the other reason is because sales, the number of procedures were not down or as soft as the sales number, right. So you could see that they were consuming some of the products that were on the shelf. And so certainly February is very early into the month. So I think it's pretty early to kind of comment too deeply. I don't have all the analytics back, but we do see that continuation of consumption on some of that loading that was done at the end of the year. We're also seeing just we believe there's a lower incidence of procedures happening due to COVID. Right, so we know that there are less accidents. We are getting feedback from different hospitals saying that there's less admissions since COVID started and so there's -- that is a bit of a factor as well and that correlates with the lockdowns, right, so as the lockdowns increase, the accidents decrease and we saw that that COVID kind of flare up in that December, January period. So, hopefully that helps a bit.

Our last question comes from the line of John Hester with Bell Potter.

Good afternoon, Mike, it's good to chat. Mike I just wanted to have a chat about the progress of the vaccine on US, 35 million vaccines provided so far, where is it with your own stuff in particularly yourself, stuff and they had access to vaccines? And what is the situation with hospitals in that given that frontline staffs are supposed to be priority for vaccines and to receive a vaccine? Can we somewhat optimistically I hope have a view that once those frontline hospital staff are vaccinated, that potentially there'll be more capability for non-COVID cases to be admitted to hospital.

Thanks, John, for your question. The way the vaccine rollouts are going in the United States are determined at the state level, it's not being managed at the federal level. So it's highly variable from state to state. And some states are well into having vaccinated their frontline workers and others have not started. So with that variability, along with even if the frontline individuals are vaccinated there are still COVID patients that are spiking COVID cases that are spiking and the patients are still there, still occupying the burn beds, which are being turned into ICU beds. And that dynamic does not really permit our reps to get more access to the hospitals. Yes, so that's really the situation on the vaccines and above as much granularity as I can get into.

Yes, okay. So it's likely there'll be many more months before we see a definite trend there.

Unfortunately, yes, it's really hard to predict hopefully with the new J&J vaccine, D&A vaccine, single shot, and no required booster, similar efficacy to that of Pfizer Moderna will be seeing faster rollouts. But again, this is being determined by state by state. So really very, very difficult to predict even by the experts.

Thank you. There are no further questions. Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect. Everyone, have a great day.