Ladies and gentlemen, thank you for standing by and welcome to the AVITA Therapeutics Fiscal First Quarter 2021 Earnings Conference Call. At this time, all participants’ lines are in a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. [Operator Instructions] Please be advised the today's conference is being recorded. [Operator Instructions] I'd now like to turn the conference over to your speaker today, Caroline Corner, Managing Director. Thank you. Please go ahead ma'am.

Thank you, operator. Welcome to AVITA Medical's fiscal first quarter 2021 earnings call. Joining me on today's call are Mike Perry, President and Chief Executive Officer; and Sean Ekins, Vice President of Finance. 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 AVITA's quarterly report on Form 10-Q for the first quarter ended September 30, 2020 for additional information. Any forward-looking statements provided during this call, including projections for future performance are based on management expectations as of today. AVITA undertake no obligation to update these statements except those required by applicable law. AVITA's press release with the first quarter of 2020 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 P.M. Pacific Time today. Now, I would like to turn the call over to Mike for his comments on first quarter 2021 business highlights.

Thank you, Caroline, and thank you everyone for joining us today. As some of you know, this is our first earnings call following the redomiciliation of AVITA from Australia to the United States and the initiation of NASDAQ as AVITA's primary listing. I'm very pleased that we have now fully aligned our corporate structure with our U.S.-based operations. And we continue to focus on our core goal of driving RECELL in both the commercial setting and in our multiple pivotal clinical trials. I'm looking forward to updating you on our performance for our fiscal first quarter, which ended September 30. But first, since many of you who are listening today are relatively new to AVITA, I thought it would be helpful to initially provide a brief overview of our story and why we believe AVITA's established commitment to clinical research provides unique growth opportunity across multiple markets. AVITA is a commercial stage regenerative medicine company, with proprietary technology that harnesses the body's own healing powers to provide skin restoration at the point-of-care. In simple terms, our offering, which is marketed as the RECELL System is best described as Spray-On Skin Cells. Clinicians take a postage stamp size sample of the patient's own skin and use the RECELL System to prepare an autologous cellular suspension, meaning a fluid like spray, and then apply this suspension on the wound or defect to regenerate natural, healthy epidermis or skin, including restored natural pigmentation. Before RECELL burn patients received skin graphs from other parts of their bodies, which made for a large secondary wound, or if the graph was meshed or stretched out, they saw poor aesthetic outcomes once they healed. Our Spray-On Skin was the subject of two randomized controlled clinical studies in the United States. And these studies underpinned our FDA pre-market…

Thank you, Mike. For the first quarter ended September 30, we reported revenues of $5.1 million compared to $3.3 million in the corresponding period last year and $3.9 million in the June quarter of 2020. Revenues for the first quarter include sales of the RECELL System in the United States a $5 million, an increase of $1.2 million or 31% over the $3.8 million reported for the June quarter. The gross profit for the September quarter was $4.1 million, representing a gross margin of 82%. This is an increase of $1.5 million from the gross profit $2.6 million of gross margin 81% reported in September, 2019. The total operating expenses for the September quarter were $14.9 million, which is an increase of $6.6 million compared to the same period in 2019. The increase in operating expenses was driven primarily by increases in personnel costs, clinical study costs associate with our four clinical studies and the cost associated with establishing AVITA a U.S. public company, including completion of our redomiciliation, the first U.S. GAAP audit for the three-year period ended June, our first proxy statement and our first 10-Q. Operating losses for the September quarter were $10.2 million as compared to operating losses of $3.6 million the same period last year. Cash on the balance sheet was approximately $65.8 million as of September 30, 2020. And now, I'll turn the call back over to Mike.

Thank you, Sean. As you've just heard, we have made great progress during the September quarter, with 30% growth in RECELL System sales and strong progress towards our goal of making the use of the RECELL System the standard-of-care in the inpatient hospital burn setting. In addition, our other developments, especially our speedy transition from receipt of an IDE to an exciting early cadence of patients in our vitiligo pivotal study, together with our strong cash position bodes well for an exciting 2021, and we look forward to providing you with updates over the coming months. This concludes our prepared remarks. And now, I'd like to turn to the operator to open the call to your questions.

Thank you. [Operator Instructions] Our first question comes from Josh Jennings with Cowen. Your line is open.

Hi. Good afternoon. Thanks for taking the questions. Mike, I was hoping to just hear a little bit more about the trends you're experiencing since September, and just remind us if there's any seasonality you should be considering in this December quarter that we're currently in, in the burn market. I think the gist of my question is really getting out it, could we see sequential revenue growth in the U.S., or should we be thinking about COVID headwinds, some seasonality where sequential revenue growth may not be implied.

So, thank you, Josh, for your question. Yes. There is a degree of seasonality that usually hits the October month. November and December are generally picking up to be normal relative to what we generally see. And so far as sequential quarter-over-quarter growth, we do anticipate that we'll continue to grow our business and not have a flat quarter, as we had in the quarter before last. Does that answer your question appropriately?

That does. No. Thank you for that. And if I could ask just about the outpatient RECELL kit development, the transitional payment is in process. Can you remind us, or provide just any color on how you're thinking about and your team's thinking about the launch in 2021, assuming that this transitional pass-through payment is granted at a reasonable level?

Yes. What we're thinking of is that if CMS is on time, so we would expect in December an answer from them relative to the transitional pass-through payment then we would get a C code that would be effective in January of 2021. With that, we would proceed into the outpatient setting and begin with our high volume centers that are already really clicking along at a high speed and moved to the outpatient setting where we see some smaller wounds, as well as less deep wounds. And that's our plan. And so far as the initial rollout then we'll start moving to the centers that are not as well and trenched and expand from there.

Thanks for those details. And then just one last question, just on the pipeline -- and congratulations with all the enthusiasm and the enrollment paid so far in the vitiligo trials. But I wanted to ask a question on skin rejuvenation and the collaboration with Houston Methodist, any more color you can provide that there will be any milestones in the next 12 to 24 months in that proof-of-concept work that you're collaborating on. And then how do you -- how should we think about just overall timelines for a potential cell therapy for skin rejuvenation from a high level, just to get a kind of framework for when you could -- we could actually see a product? This is a three-year pathway. Is it longer than three years? Any color on that would be helpful? Thanks for taking the questions, Mike.

Sure, Josh. Yeah, Methodist has developed RNA technology to deliver telomerase and has already demonstrated reversal of aging and return of functionality and the cells from progeria patients. And progeria is a genetic disorder leading to accelerated aging. So, the proof-of-concept is there. The focus and so far as our first milestone will be on telomerase in rejuvenating aged skin cells in most model and that will be taking about 18 months. But during that time, I'm not sure that we'll wait to the end of the sponsored research agreement. We'll be talking with FDA to make sure that we have all of the safety data required to enable an IND package. And then move forward into the clinic. This could be within the two to three-year timeframe or it could be accelerated depending upon how the initial early research goes.

Great. Thanks for that as well. Appreciate it.

Pleasure.

Thank you. Our next question comes from Ryan Zimmerman with BTIG. Your line is open.

Good evening. Thanks for taking the questions. Mike, maybe on the procedural dynamics you saw in the quarter, certainly encouraging. Wonder if you could speak anecdotally to the adoption and whether you're seeing new physician adoption or incrementally higher usage among existing customers? And maybe how that splits out a little bit, any color there, I think would be helpful for people to understand.

Yes. Thanks, Ryan. We're seeing both new physician adoption, as well as increased utilization by those who are using the product on a regular basis. And so far as the split, I would say that the new physician adoption is less of an impact than the existing physicians increasing their use. And that's primarily due to our decreased business development associated with COVID. As I said, in my prepared remarks before we went into Q&A, our sales reps are being allowed into the surgical suite upon request by the physicians, but -- and so far as getting access to the hospitals to get new accounts, get new physicians on board that's a higher hill to climb. And especially because the patients that are being treated, are being treated in the same centers where COVID patients are being treated. So, we see a little bit of an undulating curve there relative to is COVID spiking, is it not spiking? But that generally sums up the situation.

Okay. I appreciate that color. Maybe turning to the vitiligo trial. I think if I recall there's an interim analysis of 33 patients. And so with the eight patients enrolled thus far, is it fair to assume that that could be just on a similar cadence, around kind of the first quarter calendar year next year. Just maybe help us think about kind of when we could get it first peek at some of the data coming out of the vitiligo trial. Thank you.

Yeah. More likely, Ryan, this is going to be next summer when we'd actually hit the 11 patients per group. The, -- six months follow-up is going to be required. And for a split of those eight patients, we've got six in the pivotal trial and two in the feasibility trial. So, we're motoring along. We hope to beat our internal targets, but that's where we sit right now as of today.

Okay. Very helpful. Thank you for taking the question.

Sure.

Thank you. Our next question comes from Kevin DeGeeter with Oppenheimer. Your line is open.

Hey. Great. Yeah. Thanks for taking my questions. Yeah. Maybe just two, if I may. Just -- Mike appreciate the really detailed discussions with regard to the business. Can you just talk about how you are -- what initiatives you are taking with regard to the U.S. burn centers that do sort of move the needle for demand? You mentioned a number of the headwinds, but maybe you can talk a little bit about some of the things here you're adapting and particularly with regard to digital, but that maybe are working. And sort of on that -- then kind of maybe just go into the clinical trial side, I appreciate the commentary on the challenges and the enrolling for soft tissue, just kind of walk us through what are some of the puts and takes that you would be evaluating determine whether or not -- continuation of that -- of the current study is appropriate or some other avenue to drive demand for that channel, maybe more appropriate apart from structured clinical trial.

Sure. Thanks. Thanks, Kevin. And so far as our initiatives in digital, they're very robust. We're doing a peer-to-peer video conferences and teleconferences. We're doing trainings by digital format. We are actually doing all of the elements that we would normally do face-to-face digitally. So, we're very, very engaged in that manner. That said, the effectiveness of doing things by video, by audio and not being there in-person, is -- has a lower impact. And there's no getting around that. But we're doing everything feasible with a digital format. So that answers hopefully your first question. Your second question relative to the soft tissue trauma trial, just to give you a little bit more insight there. With the benefit of hindsight, I think we took a misstep early on and we'll own that. Our first two study sites were not really great candidates for trauma and our three enrolled patients are from a more recently initiated site. And the burns market is really more concentrated than soft tissue as you know, with 130-plus burn centers. So there -- when we start looking at the trauma centers, there are reduced number of patients at any one site. So what are we doing to address this which was your question we're evaluating our approach here with our study steering committee, but I have to say we remain confident in the market opportunity. And let me conclude by saying that all of our market research shows that we're close to like four times the RECELL procedures in soft tissue trauma as compared to burns, albeit with a skew to smaller sized wounds. And this is based upon both our market research, as well as DRG data. So, we remain highly optimistic about this indication for growing our business going forward.

No, that all makes sense. And then maybe just one follow on question. And this -- I appreciate that, you continue to suspend financial guidance here in the near term. And but with regard to potentially reinstating guidance, and as we think about 2021 as well, is the bigger challenge there limited visibility on just the size of the current inpatient burn market due to the impacts of COVID, or is it more just sort of appreciating specific customer behavior just given you some of the challenges of actually being able to you will get into the burn center and there's a pace in which some of these new sites ramp up. Just kind of help us sort of understand kind of what the dynamic that would need to play out would be for you to feel comfortable reinstating some sort of forward guidance.

Yeah. I would say it really is primarily COVID about is preventing us from giving firm guidance going forward. As various regions spike we end up with our reps not being able to get access to the centers and that leads to a slowdown also because we're still relatively early in the launch period. We have a concentrated number of sites that are providing the majority of revenues. So, we get one of those sites impacted by COVID, because they happened to be in the wrong region and that can really move the needle substantially. As we grow the business and hopefully as we continue to make not us specifically, but as COVID gets under control, more broadly will be -- we will start providing guidance going forward on revenues.

Great. Thank you for taking my questions.

Pleasure.

Thank you. [Operator Instructions] Our next question comes from Brooks O'Neil with Lake Street Capital. Your line is up then.

Good afternoon, Mike. I wanted to ask you a couple of quick questions. One, I was curious if the challenging environment had caused either internal or any changes in your sales and distribution organization. And then I was hoping you might provide us with a sense for the process you're going through to complete the CFO search.

So, I'll take your second question first. We've already started CFO search and so that is underway. The process is a traditional one. It's a retained search and we're, of course, looking for the best candidate. But importantly, we're going to assure this time that the candidate is located in Southern California and very close to Valencia. So, we're not going to have a repeat of what has happened to us in the past. And so far as our challenges for our manufacturing, I think is where you were going there. We have had employees in our manufacturing facility exposed to COVID, and this has resulted in a couple instances of temporary shutdown of our manufacturing facility in Ventura, California. But for mitigation, we actually have several months of finished goods inventory stocked on both the West Coast and the East coast remote from our manufacturing facility. So, we're well prepared to withstand even an extended shutdown should that happen. Hopefully not, but we do not anticipate any interruption to our commercial supply.

Great. Thank you very much.

Sure.

Thank you. Our next question comes from John Hester with Bell Potter. Your line is open.

Good afternoon, Mike. It's good to speak to you again. Mike, just in relation to your mix of clients, hospital clients in the U.S., you've talked previously that super users and them accounting for a certain percentage of your overall solid product sells. Can you enlighten us on how that progressed in the September quarter, please?

Sure. In the September quarter, we continued with our super users the -- we have not lost anybody that we haven't had any dropouts, if you will. So, the super users have continued relative to bringing on more of what we call the super users. And those are the ones that are really utilizing the product on a consistent and regular basis for almost all patients that present with second or third degree burns that require skin grafting. We're coming close to adding some additional ones as we progress. And as we continue on that progression curve, our sales will become more regular and more predictable. And that's the trend so far.

Is it possible then to guesstimate what sort of proportion of total procedures they'd be responsible for? I suppose what I'm getting at is -- you get COVID infection in the hospital, I have a problem there with that in that regard, what's the downside, if you like?

Well, the downside, of course, is if there is COVID infection in the hospital, there's direct competition for both burned beds and ICU beds. And that can affect our sales as well as our business development, of course. And so far we haven't had any of our super users go down completely. Variability has definitely been there, but so far touchwood we've not lost any of our super users and our high quantity users of the RECELL System. That doesn't preclude that from happening in the future, but so far so good and fingers crossed going forward.

Okay. Just a couple of following questions and just two-ones. First of all, there was discussion of a wound trial in the U.K. I wonder if you could update us on that? And also with BARDA, is there any prospective dates when they might be placing an order? Clearly, it wasn't in the September quarter. Can you update us on those two issues?

Certainly. And so far as the U.K. goes, the wound trial there was in chronic wounds and that has completed and has been wind down. We're still waiting on some final data to have a final study report -- clinical study report from that site. But as you know, we're concentrating on our pivotal in vitiligo pediatrics calls and soft tissue. So chronics right now is not front end center for us. Relative to your second question on BARDA, we will actually start stocking the VMI, the vendor managed inventory, that we managed for the Federal government in December. And then we'll be booking revenues. I can pass it over to Sean to talk about how revenues will be booked for BARDA. I think it's just going to be deferred revenues, because it's going to be spread along the -- over the duration of the BARDA contract. And it'll take us about somewhere between four to six months to fully stock the inventory and be at steady state with BARDA.

Yes, that’s certainly.

Thanks, Sean. Does that answer your question, John?

Thank you. Yes, I'm done.

Thanks.

Thank you. Our next question comes from Lyanne Harrison with Bank of America. Your line is open.

Hi. Good morning. Good afternoon over there. Thank you for taking my questions. I'm interested if we could come back to the revenue momentum. You mentioned earlier that July was the highest revenue month that AVITA had reported with 57 unique orders there. Can you give us a sense of whether you think some of those orders was restocking, or is it really reordering for use and is it aligned with the procedures that were reported in that month?

Sure, Lyanne. We generally do not see a lot of revenue from stocking. Some of our accounts do stock a few RECELL kits to have them on hand, but we're not seeing any of our customers that are really grabbing a lot of stock that would really interrupt our revenue flow.

Okay. Thank you. And then if I think about, I guess, the trend you're saying from August to today in November, are you seeing consistent increase in revenue growth sequentially month-on-month, despite the increase in COVID cases across the United States?

So, generally, I would say yes. We are seeing sequentially revenue growth month-on-month. That said, there is, of course, variability how many days of sales do we have in any one month will affect monthly sales. For example, in November, we have Thanksgiving coming. So, there are a number of days off, those types of issues. But generally the trend continues and we're going in the positive direction.

Okay. Thank you. And if I could just have one follow-up, and this is probably a question for Sean. If I think about your cost structure, obviously this quarter, it was a fairly high cost structure. You mentioned that there were a few items in there as a result of redomiciliation, et cetera. Sean, are you able to highlight what you think in this quarter's OpEx might be non-recurring if we think about the remainder of financial year 2021?

Yeah. Thanks Lyanne for your question. As you noted in our OpEx, we did have in the current quarter a lot of one-off costs and this really related to redomiciling the company from Australia to the U.S., along with having our first audit, which was for a three-year period. We also had our first proxy statement and our first registration for our shelf. A lot of that will be non-recurring. Did I answer your question Lyanne?

Yeah. I'm just trying to understand the quantum. So, if I think about your general admin expenses of $5.5 million, what proportion of that do you think might not recur in subsequent quarters?

Right. My anticipation moving forward that G&A will come down. I think it'd be come down more in the range of $4 million to $4.5 million. Like I mentioned, the amount of cost that we did have in there for Q1 was rather significant. But again that was -- the charges incurred for redomiciling the company, the first U.S. GAAP audit, which we won't have that going forward. We will have the cost for having an audit, but it will be a three-year period, which is quite substantial.

Okay. So, you're thinking it's sort of $4 million and $4.5 million. And then if I look at research and development, obviously the cost there looks like it doubled compared to the last period. Should we expect that sort of $3 million per quarter going forward, given the -- all the pivotal trials that are currently in place?

Yeah. Yeah. And I think you hit it right on the head. I mean, in the sense that our R&D did jump up in the current quarter. And this is -- just like you mentioned, it relates to our pivotal trials that we had got undergoing. My thought process moving forward and I think it'd be in the range of $3 million to $4 million, but this will be in line with the expansion of our pivotal studies.

Okay. Thank you very much.

You're welcome.

Thank you. And I'm currently showing no further questions at this time. Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect.