AVITA Medical, Inc. (RCEL)
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TD Cowen 44th Annual Health Care Conference 2024

Mar 5, 2024

David O'Toole
CFO, AVITA Medical

Good morning. My name's David O'Toole. I'm the Chief Financial Officer of AVITA Medical, and really happy to be here, to discuss the progress we've made over the last year and also the promising future we have at AVITA. I will be making forward-looking statements, and this is our standard disclosure. As far as the team, I've been with the company for about eight months now, since June of last year. Prior to that, I sold my previous company, Opiant, about a year, about a year ago. We're led by Jim Corbett, who's the CEO of the company. He brings significant experience to AVITA. He has been CEO for about 18 months, and prior to that, he was on the board for over a year. He has CEO experience and significant commercialization of medical device companies over his 30-year career.

Besides Jim, we have two wonderful executives leading our sales and marketing, Terry Bromley, who is head of our global sales, and then Debbie Garne r, who leads our marketing efforts, both of them significant experience in the industry. So as an overview, we are a commercial stage company, focused on regenerative medicine, with an aspiration to become an integrated acute wound care company. Our core business is in the treatment of burns and, after June of last year, full-thickness skin defects. We also have FDA approval for depigmentation of stable vitiligo lesions, which I will discuss later. From a commercialization standpoint, we, in anticipation of getting FDA approval last June, expanded the number of sales, our sales organization from 30 to 70, and we did that to maintain small territories to keep our revenue growth at a high rate.

We are now in the process of expanding again. We are going from 70 professionals to 108 professionals, and we're increasing our territories from 40 to 58 territories. With that expanded sales force, we are looking to add 200 new accounts during 2024, plus the 140 burn centers that we were already approved in, half of them were also trauma centres. We have a large market opportunity, with the expanded indication full-thickness skin defects, 400,000 potential procedures could be used RECELL eligible, along with 35,000 burn procedures. Our growth over the last year has been consistent, very impressive. We started last quarter, our first quarter of last year with 40% growth, then we went to 42% growth, 51% growth, and ended the year with a 50% growth in Q4 over the same period in 2022.

And then finally, as a first phase of us becoming a complete acute wound care company, we did, in January of this year, execute a distribution agreement with Stedical Scientific. We are now their exclusive distributor for PermeaDerm, which is a biosynthetic wound dressing. And we plan to do a full launch of that in March, or actually, this month. Our RECELL platform is across many indications. As of last year, we have approval for burns, as I indicated, full-thickness skin defects, and vitiligo. In 2024, we expect to get approval for our automated RECELL device, RECELL GO. We expect FDA approval by May 30th and will launch immediately thereafter, May 31st. So those of you may be new to AVITA and, as a general review, what is RECELL? Think of a burn patient with a large wound, burn on his chest or his back.

Without RECELL, the surgeon would need to take to find skin grafts roughly the same size as that, the size of the wound, very large, from someplace else in the body. With RECELL, the skin graft is significantly reduced, probably the size of a, of a credit card. So the first huge benefit of RECELL is that there is a significant donor site sparing. And you can imagine that's, that's really important for the patient because the graft site becomes a wound also that needs to heal. With our, device, with our, process, the, the wound is a lot smaller. It's going to heal a lot quicker.

And so the surgeon takes the graft the size of a credit card, and in the manual device here in the middle, disaggregates the cells manually and puts it into the tray, and then it's suspended in an enzyme and buffer solution in different wells. And the, the solution, the buffer and enzymes is part of our trade secret. It allows the cells to thrive and survive. And in that solution, there are keratinocytes, fibroblasts, melanocytes, all of them primed for wound healing. And in 25-30 minutes after it is soaked, the medical team comes back, and the, the solution is ready to be put into a spray application. And it is sprayed on the wound, and the spray application allows for a broad and even distribution across the entire wound bed.

So the end result is there is a significant effect on healing, both in the timing, less scarring. And it also reduces the time in the hospital by about 30%, which is great for the patient, more profitable for the hospital, and also better for the medical team. So that's our device now. It's manual. And we are evolving to an automated device. The manual device here is on the left. And the automated device, which again, we expect to be approved by May 30th of this year, consists of a durable about the size of a blender and a disposable cartridge here on the right. We are going to own the durable. We're going to give that free of charge to the facility. And then the cartridge, which is disposable, will be the same cost, $6,500 as the manual device.

So with the automated device, the skin graft is put into one of the wells in the cartridge, along with the buffer enzymes and buffer and enzymes in different wells. The medical staff takes the cartridge, opens the durable door, puts it in, presses a button, and walks away. And in 25 minutes, the medical team returns and the solution is ready to be sprayed onto the wound. With the automated device, we're going to be controlling two very important variables. One is the pressure to disaggregate the cells is going to be consistent, and also the soak time, both of them very important in the fact that we need to maximize the amount of viable cells and also the quality of those cells.

And one overriding benefit to the automated device is the fact that the staff is free to care for the patient while the device is running. Stepping back just a few minutes, a few words about our launch of our full-thickness skin defect, which happened in June of last year. When we got reimbursement, the inpatient reimbursement, or when we got approval, the inpatient reimbursement was the same for our burn DRG was exactly the same, effective immediately. And for outpatient, the transitional pass-through code was the same as burn. So again, effective immediately. I mentioned before, I'll say it one more time, 50% of the 140 burn centers that we were already in were in trauma centers. So with the expanded indication, there was immediate access to that expanded label.

Our sales team was also able to target the remaining 30% of the burns that were in trauma centers, and so they were able to capture that additional market. We started the value analysis committee discussions with the 800 trauma centers that are out there starting in June. And we expect to add 200 new accounts during 2024. I mentioned the sales force expansion. We internally try to keep. We have a target of keeping territories of revenue of around $2 million per territory. And when we see that averaging around $2 million, we make the decision to expand our territories again. We're doing that as of this quarter. We're adding another 38 professionals, another 18 territories in total. And so we're going to have that completed by the end of March.

So doing that from January to March within 10 weeks, it's just a terrific indication of and demand for sales and clinical professionals that want to come work for AVITA. From a growth perspective, we are looking to grow over the next three to five years, 50% every year year-over-year. And that's going to be fueled by this larger expanded indication full-thickness skin defects, as well as our legacy burn business. There's significant synergies between the burns and the full-thickness skin defect market. Again, there are 800 trauma centers and 140 burn centers. And we're going to be targeting those trauma centers over the next three to five years. We have what we believe a large market greater than 400,000, including both the burn and the full-thickness skin defects.

This slide is a little busy, and a little granular, but I think it's important for a couple of reasons. When we first applied for the PMA supplement for full-thickness skin defect, we thought that the market size was here, here on the left, about 125,000 procedures. However, a number of the patients that were in the study had wounds that were nine months, and the FDA didn't like the word acute, that was in the, in the label. So they asked us, they told us we needed to remove the word acute. And by removing the word acute in the label, it opened up these other 270,000 additional procedures that we think are eligible for RECELL. There's a number of different indications in this expanded label. And in the VAC process, we had to access multiple physician specialties in, in the facilities.

And that process took longer than what we thought it was going to take. But we figured it out. And we have over 100 facilities we had over 100 facilities in various stages of the VAC process as of the end of 2023. We plan to add 200 additional accounts, as I indicated, this year, which means that about 15 need to be approved every month. So as those 15 get approved in a month, more will be added. And we think we have a very active pipeline that can achieve the 200 new accounts this year. The other learning that we found from this expanded indication is that a large percentage of these additional wounds are smaller wounds. They're a smaller TBSA, 5% or less total body surface area.

We found that many of the surgeons are reluctant to use our standard device, which is for a wound that is 10% TBSA. It costs $6,500. So for these smaller wounds, the DRG is less. And therefore, by using a device that's $6,500, it's going to cause less profitability to the hospital. So what we've done is we are in the design phase of a product that is going to be called RECELL GO mini, which will address these smaller wound sizes. It'll be the same cartridge, but it'll have different well size for a different size of skin graft, as well as different amounts of buffer and enzyme. Use the same durable.

At this point in time, we don't know what we're going to charge for that cost, but it'll be less than our for that product, but it'll be less than the $6,500 that we're doing for the standard device. A few thoughts, a few comments on our international strategy. We aren't going to go with a large global footprint. We are going to apply a filter. And that filter, the region has to have, country has to have a developed healthcare system, has to have an economic stability, ability to pay for the advanced technology of RECELL. And it has to have a large enough population to support market entry. We're not going to build it ourselves. We're going to go through third-party distributors. And there's many benefits to that. One, we don't have to outlay the cash to build a sales team.

Local distributors know the hospitals, the reimbursement arena, and the KOLs. We are giving up, obviously, margin when we're going through a distributor, but at the same time, it's a benefit because we're getting margin dollars. With very little cost to actually get those dollars, most of those dollars drop to the bottom line. We already have a distributor in Japan. And we are in November of last year, we signed an agreement with PolyMedics Innovations. And they're leading our expansion in Germany, Austria, and Switzerland. They've already started their training in January, and they are doing cases in Germany already. We don't see the revenue from our international being significant this year, but we're going to be building a foundation over the next six to 12 months to find additional distributors in Australia, the rest of the European Union, and also UK.

So, as I indicated earlier, our first distribution agreement for product expansion was signed in January. And this is an essential step, first step of our goal to become an integrated acute wound care company. PermeaDerm is a dressing, a transparent bio. It's a biosynthetic wound matrix, but it's basically a transparent dressing with a high degree of porosity. The dressing is see-through so that the medical staff can put it on the wound and can see how the wound is healing without having to rip it off, which might interrupt the healing process. It also has pores. The porosity allows for air to circulate and also allows excess fluids to seep out. As far as economics, this product sells for around $0.80-$1.20 per square centimeter.

For a typical RECELL patient, which is 10% TBSA on 1,920 square centimeters, we would be looking at around $2,000 of gross revenue with the use of this dressing for a RECELL patient. With a 50/50 split between Stedical and us, we would net $1,000 in that case. Again, all of that would be gross margin, but it would at very little cost to sell it. So all of that drops again to the bottom line. We look to launch, full launch here in March. And we are, this is only our first step. We're looking to do additional product expansion. The one that's the most active right now, we're in animal testing and also in discussions with a number of dermal scaffolding opportunities.

We look to be able to announce that sometime very soon with our next product expansion. A few words on our longer-term opportunity called Vitiligo. We already have approval by the FDA, which was in June of last year. The study that was done was good enough to get FDA approval, but not adequate for reimbursement. The average Vitiligo patient is 40 years old. Therefore is not covered by CMS. Now reimbursement will be through commercial payers. So immediately after getting FDA approval, we kicked off a post-market study called TONE with an additional 109 patients. That study looks to evaluate the repigmentation and understand the impact on improving the quality of the patient's life following treatment. The study was completed in January. I mean, the enrollment was completed in January.

We look to do a 6-month follow-up, which will be in July. Then we've added a 12-month follow-up to support additional data. In addition, we're working with a health economics firm to capture the longitudinal healthcare costs of the Vitiligo patients. They consume a significant amount of healthcare costs. What we are going to try and capture with this study is to determine how much that cost is and then how much can be saved by treating the Vitiligo patient. With those two studies, we plan to submit for publication the end of this year, first part of 2025. Once they're published in a journal, we will start conversations with commercial payers on a regional basis, picking the larger regions first, Florida, New York, Texas, California, and getting those regional payers to agree to reimbursement.

Once we get reimbursement, we will hire a sales team to go forth and obviously in that region sell the product. It's not going to be a large expansion. It's going to be a rolling sort of rollout of vitiligo. We don't see this being a revenue generator until sometime probably in 2026. A few comments on our financial situation. I've already talked about the manual devices at $6,500. The automated device, again here pictured, is going to be given to the facility at no cost. The disposable cartridge will be $6,500. The RECELL GO Mini, once it's approved, we will determine what that cost is going to be. It'll be something less than $6,500, but we haven't made that determination yet. We're in a really strong financial position. At the end of 2023, we had approximately $90 million of cash on our balance sheet.

In October of last year, we did enter into a debt facility with OrbiMed for $90 million. We took down $40 million at closing, and that $40 million is included, obviously, in the $90 million at the end of the year. We have two $25 million tranches that are available at our option. The first one is available through 2024. If we don't take that one, the second tranche expires also and would not be available. We do not foresee at this point in time the need for either one of those tranches. We believe we have sufficient capital to meet our goals and to reach profitability. We have given guidance, financial guidance for this year. For the first quarter, it's $14.8 million-$15.6 million, reflecting again a growth rate of around 50%. 2024, for the entire year, it's $78.5 million-$84.5 million.

At the midpoint, that's a 63% growth rate. Important to note that we, that guidance at $78.5 million-$84.5 million does not include any revenue from PermeaDerm or any of our other, product expansion. So that's all upside at this point. And the really important point here on this slide is we've given guidance that we expect to be, cash flow breakeven, free cash flow, GAAP profitability no later than the third quarter of 2025. A couple of comments on this slide. First one, we have, for the last four quarters, and we will, again have at this quarter, we've had sequential revenue growth every every quarter. Our gross profit margin is in the range of 85%. And we had year-over-year growth for 2023 of of 46%.

So I'm going to skip 2023 summary and just move to 2024, because really focused on what we're going to do here in the future, not already talked about how 2023 was a great year. So just to summarize, we are increasing our sales organization from 70 to 108. That'll be finished by the end of March. We're integrating PermeaDerm, the biosynthetic wound dressing, into our selling portfolio, and we'll launch that in this month. And we continue to look for additional products. The one on our radar right now is dermal scaffolding. For RECELL GO, we expect FDA approval by May 30th with a launch on May 31st. And we plan to submit a PMA supplement for our RECELL GO Min i, which addresses the smaller wound sizes that I talked about, and then we would expect FDA approval by year-end.

We already have some international sales in Germany, Austria, and Switzerland. As far as international, it's not going to be a significant amount of money this year, but it will, we are building the foundation, and in 2025, that revenue will be more material than it is in 2024. And then lastly, for a loss company such as ours, who has, who for the last couple of decades have only been in a loss, we see a pathway because of the commercial revenue growth to achieve cash flow breakeven and GAAP profitability no later than Q3 of 2025. And so with that, I thank you for your attention, and I'll take two minutes of questions. Yeah, on the RECELL GO Mini i device, yeah, I understand that pricing is still something that you guys are working out. Is there any cost differential between a mini device and a standard RECELL GO?

Yeah, the cost of goods sold will be exactly the same. So the thought there is that we will be giving up, you know, our gross margin will be less on RECELL GO Mini, but we're going to make it up in volume because of the fact that there's so many significant, smaller wounds in that expanded label, full-thickness skin defect. Yes. Can you talk about the training aspects for medical staff training of the old device versus RECELL GO? Sure. And what you're hearing from clients and the compliance as to what's the old device failure? Great question, and thank you. So the manual device is a very technical sale for us right now. We have, as I said, 58 sales reps, but we have 29 what we call clinical tissue specialists.

They are the clinical consultants that are actually in the operating room with the surgeons, showing them how to manually disaggregate the cells, what to do with the buffer, what to do with the enzymes. So that whole training process is pretty extensive for the manual device. When we move to the automated device, the training, I could teach you how to do it, to be honest. You put the graft in this cell, you put the buffer in this well, you put the enzyme in this well. You open up the door, you put it in, press the button, and you're done. It does it all by itself. So we believe that it will accelerate the adoption of using our RECELL technology. There won't be this large amount of training that will be necessary.

The surgeons, the salespeople can show them how to do it, and it should help as far as the adoption of getting more accounts to use the device. Is there another question?

Speaker 2

So it's basically a spray-on instead of the graft. How long does it take to heal? And is that a long-term recovery? Well, it's quicker healing because the patients are getting out of the hospital 30% faster than if they just had a normal skin graft. And so we believe the healing is quicker and the scarring is less using, not believe, we know that the healing is quicker and the scarring is less using our device. And I think that's it. I'm running over my time. So thank you.

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