AVITA Medical, Inc. Q2 FY2021 Earnings Call

Ladies and gentlemen, thank you for standing by. And welcome to the AVITA Medical Second Quarter Earnings Conference Call. Please be advised that today's conference may be recorded. 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 undertakes 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 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 2019. We are becoming increasingly confident that RECELL is rapidly evolving to become the standard of care within burns, which we see as a $260 million US market opportunity. Today, we are extremely proud to have used RECELL to treat over 10,000 patients globally across a variety of indications, and our 186 peer-reviewed publications and presentations depicting outcomes in over 2,000 patients exemplify our enduring commitment to improving the lives of patients through our clinical and our R&D efforts. Importantly, the RECELL system is not limited to applications in burns. We currently have three pivotal or registration clinical trials in progress in the United States that seek to leverage our PMA approval by a variety of label expansion opportunities. These indications involve prospective applications of our RECELL technology to patients who have lost their epidermis through injury or accident and for those patients who have impaired epidermis due to skin defects or abnormalities. As we've discussed over this past year, we are especially excited about our opportunity in treating stable vitiligo, a common yet undertreated skin disorder. And I'll update you on our progress here in a few moments. Beyond our near-term clinical pipeline prospects, we are exploring applications for use of the RECELL system within the cell and gene therapy arena to attend to a significant number of life-threatening or debilitating skin disorders. And I look forward to updating you as our R&D efforts move forward. So with that quick background on the company, I will now turn to some highlights from our recent quarter. While our revenues in the second fiscal quarter were, like so many of our peers, hampered by COVID-19, we have continued to demonstrate progress with both our legacy burns business and our pipeline initiatives. Our burns revenues were flat compared to the previous quarter ended September 2020. However, we did open eight new hospital accounts, bringing the total number of burn centers with access to the RECELL system to 93. With the ABA estimating that there are 136 burn centers in the United States, we're very pleased with our commercial team's success in developing such a broad footprint in the market. We saw 485 RECELL procedures in the quarter, essentially flat from the 496 procedures we saw in the first fiscal quarter. As we look ahead and as COVID-19 abates, with more of our population being vaccinated, our salesforce will be primarily focusing on driving and expanding usage within our existing accounts. For now, however, with COVID-19 resurging beginning in November of last year, our sales reps are limited to case support in those centers that are still able to treat burns. While we are seeing very limited live in-person training activities, our employees are rarely permitted to engage directly in the aftercare setting. And therefore, live dialogue and access has transitioned to best or has otherwise been transferred to a digital format. With all the recent closures and reallocation of hospital resources, as well as some stocking orders that occurred in December, January sales were the softest we've seen since the pandemic began. Here in February, we're seeing some recovery in sales as centers work through stocking orders although we are still feeling the impact from reduced access and capacity limitations. To illustrate our challenges more clearly, I'd like to present a real-life example. There was a recent accident in California where three individuals were severely burned, all of whom we believe could have been candidates for RECELL treatment. Due to hospital capacity constraints, each of the three individuals was sent to a separate facility for treatment. One facility had a burn bed with a physician already familiar with using RECELL and that patient was indeed treated with RECELL. The second patient went to a facility that was still in the process of securing VAC or Value Analysis Committee approval, so that patient could not be treated with RECELL. Of note, RECELL has since been approved for use at that center. The third patient went to a hospital where the burn surgeon who had adopted RECELL was on maternity leave. In non-pandemic times, the three patients would likely have been transported to a single burn center for treatment, and our reps could have made contact with the treating physician and enabled access to RECELL for all three patients. You can only imagine how frustrating this type of environment is to our reps and to the treating physicians. I trust this example helps demonstrate the access issues we are encountering during these trying times. With that said, we have been encouraged lately to see broad use of the RECELL system across different wound sizes, injury types, and anatomic locations. We have also seen an increasing number of unique surgeons using the products, which we view as a healthy leading indicator for future growth as we drive increased penetration into our account base. In both our pre-release and earlier in this presentation, I mentioned our strong progress in our pipeline vitiligo efforts; we continue to see a remarkable level of interest in vitiligo study from physicians, sites, and patients. And we have a strong pipeline of new sites looking to participate in this clinical trial. Vitiligo continues to be our fastest enrolling study, and therefore we predict it will be our next approved indication for the RECELL system. For those unfamiliar with the condition, vitiligo is a skin disorder characterized by deep pigmented areas of skin that appear as white spots or patches, and which are primarily attributed to an underlying autoimmune disorder in the patient. Many people associate Michael Jackson with this disease, which perhaps represents the most famous example of this disorder. Yet vitiligo truly represents a sizable market opportunity for us. There are an estimated 100 million sufferers of vitiligo worldwide, including approximately 4.5 million Americans. Of those in the US, we estimate approximately 1.3 million have stable vitiligo, meaning that their underlying autoimmune issue is being well managed, and the disease is not continuing to spread, and new white spots are not appearing. The stable vitiligo market in the US currently represents approximately a $5 billion opportunity, and there is no FDA approved product presently available to enable repigmentation for these patients. In addition, we expect to see an increasing number of patients with stable vitiligo who meet the criteria for RECELL treatment due to the emergence of new treatments to stabilize the underlying disease, such as insights and new therapeutic ruxolitinib, which is currently in Phase 3 clinical trials. Furthermore, Sigma's recent determination of medical necessity and correspondingly strong reimbursement support of $38,000 over a 12 month period points to positive reimbursement trends for patients requiring treatment of their vitiligo lesions. These are very solid and encouraging signals that bode well for use of the RECELL system as we seek to be the first curative and scalable therapy for repigmentation of patients with stable vitiligo. In the second fiscal quarter, we enrolled nine additional patients in our pivotal study assessing the use of the RECELL system to treat stable vitiligo. Since then, we have enrolled another patient, bringing our total to 211. You may recall that we were granted investigational device exemption in early July, followed by IRB approval and site contracting in September, which is when we also enrolled our first patient. Today, our pivotal study currently has seven sites enrolling patients, and we expect to complete enrollment of this trial by the end of 2021. Assuming usual FDA review timelines, we believe we could be in a position to enter the US market commercially with the indication as early as the second half of calendar year 2023. You may recall that we have two other pivotal trials ongoing, both with the goal of expanding our PMA label into new indications. Much like what we are observing with our commercial efforts in burns, our pediatric scald and soft tissue reconstruction or trauma studies have been impacted by the pandemic, largely because they are performed in facilities that are directly caring for COVID patients. Even under normal circumstances, enrollment can be challenging because there is no referral pipeline for these sorts of patients in studies, and due to the fact that these cases are emergent, random, and accident-driven. Therefore, the restrictions we're seeing due to COVID are having a material impact on enrollment. With that backdrop, I am however, pleased to report that in our soft tissue trial, we are now set up to receive patients in 10 centers, which should place us in a better position to enroll once patient volumes and facility operations return to some semblance of normality. I'd like to add that opening new sites led to the recruitment of five patients in January, a record month, although we anticipate enrollment to remain lumpy for the foreseeable future. We plan to complete recruitment for our soft tissue injury trial in calendar 2022. And with a six-month follow-up for patients in this trial, we're aiming for an approval in calendar 2024. In partnership with the University of Colorado Gates Center for Regenerative Medicine, we're continuing to make progress toward preclinical proof of concept of a system for delivery of genetically modified skin cells. As a reminder, our objective for this program is to develop a therapeutic for correction of the gene defect associated with epidermolysis bullosa or EB, a debilitating orphan skin disorder. This work potentially paves the way for treatment of other genetically correctable skin disorders or genodermatosis. Also, we are pleased to have announced our partnership with the Houston Methodist Research Institute to develop a therapeutic involving molecular reversal of skin cell aging. We have initiated this program, and the Methodist and AVITA Scientific teams are working collaboratively on the delivery of a novel RNA-based telomerase to skin cells. Overall, we are very encouraged with the progress we have made towards establishing and advancing the sponsored research programs with leading academic institutions. And we are thereby setting the stage for long-term growth for AVITA Medical. I'd now like to walk you through some of the growth drivers we see ahead. Starting with reimbursement, the company is seeking a transitional pass-through payment application known as a TPT, which will support a separate additional Medicare payment for the RECELL system, specifically for its use in the outpatient setting. We have communicated previously that we had hoped that the Centers for Medicare and Medicaid Services, or CMS would have made its final decision in December of last year with a C Code to be implemented with effect on January 1st of 2021. However, we experienced a delay due to COVID-19. I would like to emphasize that we have no reason to believe this delay is due to anything beyond COVID-19. If and when we receive a C Code, our team is poised to initiate and leverage a pilot launch to approach commercial payers to seek coverage for those in the outpatient setting. Based on the new timeline, we expect the initial outpatient sales to commence by the end of calendar 2021 ramping to a broader launch into this market segment in 2022. Moving now to our next growth driver, we anticipate broadening our geographic footprint over the coming years. To that end, together with our commercial partner COSMOTEC, we continue to seek approval in Japan. As previously reported, we completed the three required non-clinical bench test studies in August of 2020 as scheduled. Our efforts and interactions with COSMOTEC and the Japanese Regulatory Authority are ongoing. But at this time, due to the broad labeling applied for, I do not have an update on when we might advance our application for marketing approval of the RECELL system under Japan's Pharmaceutical and Medical Devices Act, or PMDA. We continue to prioritize the US and in parallel, we are continually re-evaluating our re-entry into ex-US markets as we add new clinical indications for the RECELL system. Next on the list, I mentioned our three pivotal clinical trials earlier, and we are working toward our goal of having our vitiligo product approved and on the market in calendar 2023 with our soft tissue or trauma indication to follow in 2024. I still do not have a clear line of sight on the cadence of recruitment in our pediatric scald study sponsored by BARDA. However, I'll keep you updated as enrollment in this trial transitions to a more predictable pace. Beyond these indications, we are working on moving forward with our cell and gene therapy work. This year in our EB and our rejuvenation efforts, we are focusing on preclinical proof of concept with plans to speak with the FDA toward the end of this calendar year to determine a path forward into clinical trials. Next undergrowth initiatives, we will continue to drive forward on physician engagement and education. This year at ABA, we have 15 abstracts accepted utilizing the RECELL system, which is the highest number we have ever had at ABA. Additionally, in 2020, we had seven articles published in peer-reviewed journals, and currently in 2021 we already have the same number presently under review. For my next point, it almost goes without saying that our commercial team will be continuing to drive penetration into our burn center accounts. While we expect the growth in the number of accounts to slow down since we are already in 93 of 136 centers, our sales team is focused on increasing usage and penetration within these accounts. Presently, more than half of our RECELL revenues come from approximately 20 accounts. While we don't think this pattern is unusual for a product launch at our stage, it does speak to the sensitivity of our top-line revenue to burn center closures or staffing changes at these facilities. While that's not a metric we will necessarily update moving forward, I mention it to demonstrate firstly that some of our physicians are using RECELL very frequently and secondly, to highlight the large opportunity ahead of us to drive more deeply into our many accounts once COVID begins to wane. In summary, looking ahead, we genuinely believe in the broad utility of the RECELL platform across multiple indications. And despite the challenging macro environment, we're encouraged by our sales force's demonstrated ability to build our burn center account base and thereby teeing us up for future procedural growth. I am more encouraged than ever by the enrollment cadence of our vitiligo trial. And I look forward to updating you as we continue progress on our objective of bringing a robust and scalable treatment to this underserved patient population.

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 in 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 the September 2019 quarter. The increase in gross margin is largely driven by our increased shelf life, along with reduced shipping cost and increased production at our 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 separated 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 31, 2020. With that, we thank you for your attention. And now I will turn the call back over to the operator for your questions.

Our first question comes from 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 is well documented. Now I wanted to ask a couple questions on 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 depigmented 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 the 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 treating 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 set 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 RECELL 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 more detail on the specifics of 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 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 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 remain 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.

Thank you, Mike. Hi, Kevin. There are a few things to consider once we receive the code, specifically regarding Medicare and Medicaid, which currently cover less than 15% of hospital patients. We need to ensure that commercial payers are onboard, providing coverage and payment, rather than rejecting claims, before fully entering the market. Our plan is to conduct a pilot launch at around six centers once we have the code, collaborating with them to ensure that procedures are performed and reimbursed properly. Once we are confident that there is adequate coverage, we will expand to a larger number of accounts. However, as you can understand, it takes some time for procedures to be completed, submitted, and for us to work through any potential denials, which affects our timelines.

As you consider the process of establishing interactions with payers in the outpatient setting for the burn market, that timeline is slightly ahead of the prospective launch for vitiligo, but not significantly so. Do you see any opportunities from an educational perspective to start a conversation with payers about the vitiligo indication as part of the outpatient burn discussion, or is this more of a practical or logistical issue, indicating that these discussions and timelines are quite separate?

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 in different points of care.

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

Thank you for answering the questions. I appreciate the insights. Regarding the 20 burn accounts you mentioned, Mike, could you discuss the utilization within those accounts since they are strong users of the technology? Also, what specific capacities do you have in those accounts? Additionally, I'd like to know about the trends in utilization within the other 73 accounts, especially in light of the absence of 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 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 the 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 of RECELL, in terms of 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 approved through the value analysis committee, they averaged last year about 8% of total admissions. So if you average for all our customers, we're 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 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 to 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 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 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 surgeon's 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 very 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 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 employee base vaccinated, we will be able to have a return to the office. But overall, very, very positive on how employees continue to engage during these trying times. I'm going to pass it over to Erin for specifically on the sales force 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 contact. Erin?

Yes, absolutely. So it's challenging, right. And at times, it's certainly frustrating when you can't get in there and sell, 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 a variety of different things, right. So that they can have various shots on goals. 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 that AVITA is 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 failed to mention, our Ventura facility where we do our manufacturing, and those employees have 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?

Thank you for your question, Lyanne. Currently, we are focusing on burns. Analyzing the economics, we find that pursuing burns in Europe and Australia would result in a negative return on investment. This is due to the lower incidence of burns in those regions and the extensive work and funding required for local clinical trials to obtain reimbursement in European countries, for instance. Our main focus now is to enhance our pipeline by introducing new indications such as vitiligo and trauma soft tissue. Following that, we plan to explore opportunities beyond Japan, re-entering Europe, Australia, and other parts 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, 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 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 regarding 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 were down for the second quarter of 2021. Can you give us some color on how that trended by month? 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 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 are 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.

The committee may have added some additional insight. We believe there was some inventory loading because the rebate coincided with the end of the compensation period. Additionally, the number of procedures wasn’t as low as the sales figures might suggest. We observed that some products were being used from our stock. However, it’s still early in February, so it's too soon to make any definitive comments. While we don’t have all the analytics yet, we do notice a continuation of consumption related to the inventory loading that occurred at the end of the year. We also think there is a decreased frequency of procedures due to COVID, as there have been fewer accidents reported. Feedback from various hospitals indicates a reduction in admissions since the onset of COVID, which may relate to the lockdowns; as lockdowns tightened, accidents decreased. We noticed a spike in COVID cases around December and January. I hope this information is helpful.

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 in the US, 35 million vaccines provided so far, where is it with your own staff, in particular yourself, stuff, and they had access to vaccines? And what is the situation with hospitals in that given that frontline staff 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 the 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 those patients are 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. 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.