Good day and thank you for standing by. Welcome to the AVITA Medical, Inc. Third Quarter 2024 Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. [Operator Instructions] Please be advised that today's conference call is being recorded. I would now like to hand the conference over to your first speaker today, Jessica Ekeberg. Please go ahead.

Thank you, Operator. Welcome to AVITA Medical's third quarter 2024 earnings call. Joining me on today's call are Jim Corbett, Chief Executive Officer; and David O'Toole, Chief Financial Officer. Today's earnings release and presentation are available on our website, www.avitamedical.com, under the Investor Relations section. Before we begin, I'd like to remind you that this call includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are neither promises nor guarantees and involve known and unknown risks and uncertainties that could cause actual results to differ materially from any expectations expressed or implied by the forward-looking statements. Please review our most recent filings with the SEC for comprehensive descriptions of the risk factors. Any forward-looking statements provided during this call are based on management's expectations as of today. I will now turn the call over to Jim for his comments.

Thank you, Jessica, and good afternoon, everyone. If you've been on our previous calls, you know I am passionate about Avita Medical. I'm especially excited to share our incredible third quarter results with you today. We not only exceeded our second quarter record revenue, but also surpassed it by 29%, achieving $19.5 million in commercial revenue during Q3. This wasn't just about exceeding expectations. It was a breakthrough quarter that further strengthened our growth trajectory. This quarter was critical for us to deliver strong revenue growth while advancing our strategic initiatives. To do this, we focused on converting our business to the RECELL GO platform. The move was essentially not only to support immediate revenue growth, but also to continue to lay the foundation for our long-term scalability. This accelerated transition to RECELL GO allows us to treat more patients and expand our market reach. In doing so, we fulfill our promise to provide the best possible patient care. Now, let's start with a major milestone. By the end of September, we had successfully transitioned approximately 75% of our revenue base to RECELL GO. This is a huge achievement that speaks volumes about the execution capabilities of our team. Moreover, we managed to do this within just four months of FDA approval, demonstrating our operational agility. Our commitment to RECELL GO conversions was instrumental in driving Q3 commercial revenue growth, helping us hit our projected revenue guidance range of $19 million to $20 million. However, this focus resulted in 23 new account conversions for full thickness skin defects versus our initial expectations of 40 to 50 accounts during the quarter. The bigger picture is that we now have approximately 300 accounts across both burns and trauma centers for full thickness skin defects, which is more than double the number of…

Thank you, Jim. I want to echo Jim's enthusiasm. This was a fantastic quarter for us. We built on the success of our strong second quarter, outpacing that performance by 29%, to deliver third-quarter commercial revenue of $19.5 million, representing 44% year-over-year growth. This significant revenue achievement brings even greater clarity to our path to reach cash flow break-even and gap profitability no later than the third quarter of 2025, which we have previously signaled, all without significantly growing our organization over the next 18 to 24 months. As you can see on slide 6, our strong revenue growth reflects the demand for RECELL GO and the operational efficiencies we have built within our commercial operations. We expect this positive trajectory to continue into 2025 and beyond. While RECELL currently drives the majority of our revenue, we anticipate that Cohealyx and PermeaDerm will become substantial revenue contributors over the coming quarters. Now, let me turn to our financial results to provide some details. Gross profit margin for the quarter was 83.7%, down slightly from 84.5% in the same period of 2023. The decrease was expected due to ongoing engineering and validation of the RECELL GO durable and disposable cartridge. However, this decline was temporary, and we anticipate that our gross profit margin will be in the range of 85% to 86% for the full-year 2024. Total operating expenses for the quarter were $30.2 million, compared to $21.1 million in the same period in 2023. The increase in operating expenses is primarily attributable to an increase of $4.6 million in sales and marketing expenses due to employee-related costs, including salaries and benefits, commissions, and travel expense, collectively, as a result of expansion of the commercial sales organization in the second quarter of 2023, and again in the first quarter of this…

Thank you. At this time, we will conduct the question and answer session. [Operator Instructions] Our first question comes from the line of Brooks O'Neil of Lake Street Capital Markets. Brooks, your line is live.

Thank you very much, and good afternoon, everyone. I guess I wanted to ask you first about what you're seeing in the hospitals and your experience with the VACs. I heard you say you came up a bit short of expectations in terms of new approvals this quarter. But can you give us some color about the process in general? What you're seeing, and whether you plan to adapt in any way to accelerate success through VACs.

Hey, Brooks, good to hear from you. I think we were emphasizing something a little different. I'll get to your question here. First, we made a pivot during the quarter for the purpose of accelerating the conversion into the RECELL GO platform, because that is a driver of adoption, okay? So, we deliberately focused on that, and only one hospital required a VAC approval for our RECELL GO. In that context, VAC was not a factor. We do find the VACs in the full thickness segment, which has been, upon reflection now looking back over about a year and a quarter, we are finding that in nearly every case, somewhere in the process, the VAC is wanting to see an evaluation case or more. And so, when we get the driver of why VACs in general have taken us longer than we anticipated at the beginning of the whole process a year and a quarter ago, it's that fact. And so, we've adapted to that, and we've now been more proactive about being prepared for that eventuality. So, they're either doing it as a precondition to a VAC submission, a conditional approval, or a follow-up in some form or another. In some cases, multiple procedures they want to see. So, the fact that we had less than we expected was actually a deliberate choice of sales time. So, I hope I got your question contextualized in there somewhere.

You did. That was very helpful. So, I'll just spin it a slightly different way and ask you, obviously, you had a major expansion of the sales organization end of last year, beginning of this year and new sales leadership. Can you just comment about how you evaluate the performance of the sales team and the new sales leadership in terms of trying to drive long-term growth for the company?

So, the first part of that answer, how I'm evaluating it, begins with 29.6 consecutive quarter growth. I think the sales leadership team is developing really well under our new sales leader. We're executing in a more effective manner. That growth consecutive quarter is unusual, and we still are expecting a strong Q4 as well. So, I'm really quite pleased with the progress. There's more work to do, as always, but really, the performance this last quarter was quite good.

Great. Thank you very much. I'll jump back in queue.

Thanks, Brooks.

Thank you. Our next question comes from the line of Ross Osborne with Cantor Fitzgerald. Your line is now open. Ross, your line is now open.

Great. Thank you. Sorry about that. So, may be following up on the prior question, but with regards to many, how should we think about the adoption curve in 2025 from your learnings with getting GO into account?

Thanks, Ross. Well, first of all, the full thickness cases that we did, if you go back and you look at our FDA study that we performed that gave us approval for that broad indication, you'd see that not one patient was over 500 square centimeters. And so, when you have a device that treats 2,000 square centimeters, intellectually, that creates a little bit of dissonance, we think, for the customer. And so, we developed Mini to get at that broader population of RECELL indications where it would better fit the patient's need. And so, I think, on one hand, the market opportunity that we had preceding the introduction of Mini is fundamentally the same. I think adoption will be a little bit quicker with the concept that you're matching the RECELL use with the size of the wound.

Got it. That makes perfect sense. And then, sticking with 2025 in a year where we expect to see significant and incremental demand relative to share, how are you feeling about manufacturing capacity to meet that demand?

Actually, we feel terrific. In fact, we had a project underway that we completed during the early part of quarter called Project Phoenix, which was to really revamp our whole manufacturing facility that's located in Ventura. It was an older building. By fundamentally reconstructing the walls of the building inside, because it was an older building, our objective was to create 10x capacity expansion with that project, which we did and we completed it. So, we're feeling really good about our capacity. We've expanded some of our engineering capabilities in that facility because manufacturing the RECELL processing device is a very different set of skills than what we needed before, so we've increased our engineering talent in Ventura as well. By insourcing the manufacturing of RECELL GO, we also created a service center so that we could service the durable. So, we're feeling very comfortable about our capacity, and we haven't had any supply shortages or anything close during a time when really we have been expanding our revenue quite quickly.

Great. Congrats on the progress and strong quarter. Thank you.

Thanks, Ross.

One moment for our next question. Our next question comes from the line of Josh Jennings at TD Cowen. Josh, your line is live.

Hi. This is actually Eric on for Josh. Thanks for taking the question, and congrats on the nice quarter here.

Thank you, Eric.

Thinking about all the different growth drivers you have in the works currently, I was hoping just to get your thoughts on around how you see things evolving over the next few quarters and ultimately in 2025, in terms of where corporate growth may wind up. I think if I look at street estimates right now, showing some solid growth acceleration of 24 in the 50% range. If you can, I was just hoping to get your thoughts on how you think that step up, or if you think that step up is appropriate there.

Let me come at that in a different way, if you don't mind because we're not quite ready to give guidance for next year. You're correct. What we have is we have RECELL GO, which is having a consequence of increasing usage of RECELL in the account. We have RECELL GO Mini first of the year. PermeaDerm, now we're accumulating the clinical evidence where you'll see that expand going into next year. And Cohealyx, which is a substantial market size, will be doing a limited launch in clinical data development during Q1 for a full launch in Q2. You are talking, yes, about a lot broader growth platform. And when you add to it our entry into the European Union and Australia, there's an abundant opportunity for growth for us. So, I think the big outcome that we're focusing on is the Q3 crossover into profitability, which we have guided on. So, I think in combination of growing, we're going to be doing so without adding very little operating expenses that are durable.

Understood. I appreciate that color. And then, maybe on Cohealyx and PermeaDerm, there was a comment earlier in the call about those offerings becoming substantial contributors in the coming quarters. I was just hoping to get your thoughts on how you think that might impact gross margins going forward, particularly next year as you approach some of those profitability targets.

Yes, that's a great question. So, think about it this way. The gross profit on those product lines is less as a percentage than RECELL. However, since we're not adding commensurate operating expenses, the operating margin contribution is substantial. So, for example, with Cohealyx, a use of Cohealyx in a 2,000 square centimeter wound might be somewhere between 18,000 to 30,000, depending on ASP. So, there's a broad range of possibilities. Half of that will be operating margin. So, when you think about gross margin, think about it as total gross margin, and we're adding to it significantly with those products.

That's very helpful. Thank you for the questions.

One moment for our next question. Our next question comes from the line of Matthew O'Brien with Piper Sandler. Your line is live.

Hi, this is Samantha. I'm for Matt. Thank you for taking our question. I guess first, we'd like to touch on the guidance headed into Q4. I think it's just more of a sizable step up from what we saw this quarter. So, could you just talk a little bit about what the guidance makes in, maybe in terms of wounds versus burns and what you're thinking in there?

Well, the step up actually from Q2 to Q3 in absolute terms was in excess of $4 million, right? 15-1 to 19-5 was almost $4.4 million. Actually, the step up in Q4 is a little bit less because that guidance range is 22-3 to 24-3, as we've said it. Now, our strongest area of our business is burns and the one that benefits the most from RECELL GO is the burns business because on average, multiple RECELL devices are used in the average burn case. When you think about that, just to follow my thought here, when you use RECELL, when it's the manual version, you do it consecutively. It requires a fair bit of staff time and we often attend those cases to provide clinical support. When you use RECELL GO, you actually can run two RECELL GO devices simultaneously. What happens in that case, you reduce operating room time, you reduce anesthesia time, you reduce staff time, and you accelerate the time to begin healing for the patient. All of this saves money. So, what happens as we move into Q4 and beyond, one of the reasons I mentioned that we thought that we could imagine doubling our share of the 35,000-a-year RECELL-eligible patients in the burn market is just for that reason. And so, full thickness will continue to develop fast for us because it's a new account ad and it's new procedures. But in the burn market, we get real leverage real fast. They use one RECELL GO in a typical full thickness case, which is usually a single RECELL device where you use multiple with burns. So, it inevitably it will grow faster in burns on a hospital-level basis. Is that helpful?

Yes, that's helpful. Thank you. I just want to touch one more on the CE mark delay. What impact does that have on your growth expectations for next year?

Not significant. If you just annualize our Q4, we're going to have a strong year next year, particularly with us holding the head cap line. So, the international expectations, those are all us entering new markets. So, you can expect a lot of training will go on, careful choice of patients that get treated. They're all third-party distributors, so you have to work with them and get them prepared. Although there's going to be a little bit of a delay, we don't have a high dependency, per se, on the revenue to achieve our Q3 profitability goal.

Thank you. I appreciate that. And then, if we could sneak just one more in, we were wondering if you could talk a little bit more about the rollout plans of GO Mini, and just what your plans are there.

So, in the first instance, we're expecting it, RECELL GO Mini, to get approved by year end. That's when our 180 days are for that, because it's a PMA supplement. We then would be training during the first-half of January. We're having our sales meeting during that time, and we will then roll out Mini during Q1. It will be targeted at the trauma centers, which is where the full thickness skin defect market is primarily. They do those smaller wounds also in burn centers, but the bigger population of accounts and cases is in the trauma centers. We'll be rolling it out into those accounts. By that time, we will have added well over 200 accounts since we achieved full thickness approval last year. So, I think that rollout will begin in the second-half of the first quarter, in terms of practical utilization. It will be one of our GO growth drivers with -- if you think about our new product flow, we have a RECELL GO platform during Q1. It'll be in its expansion mode because the accounts have been already introduced to it. We'll be adding Mini, which uses the same processing device, which is durable. We have PermeaDerm and we have Cohealyx. So, we'll have a nice suite of new products to join in the RECELL GO Mini. Of course, Cohealyx and PermeaDerm get used with those same wounds as well. So, it's going to be a pretty exciting year for us next year.

Great. Thanks so much.

Thank you. [Operator Instructions] Our next question comes from the line of John Hester of Bell Potter. Your line is now live.

Good afternoon, Jim and David. Thanks for taking my call. I just wanted to ask you and come back and focus on this post-market approval study for Cohealyx. As you know, extracellular matrix category is very well-established. So, can you tell us a little bit more about this trial? What specific wounds are you going after? Yes, please.

Thanks, John. Actually, I'm going to come at that question a little bit differently in terms of what we want to prove. What we're proving is the time of ready to graft because remember this is a two-stage procedure and it's the time to close. In our preclinical work, in the porcine model, we compared Cohealyx to the other major players, let's describe it that way, and measured those two parameters primarily. What we found is that Cohealyx gets ready to graft without infection more rapidly than our anticipated competitors in terms of days, so days faster. And days faster for graft ready makes it days faster to close. Days faster to close makes it days faster out of the hospital. So, those are the three elements of what we are wanting to demonstrate and prove.

Fair enough. So, I would think trauma and burns are the primary targets there. Just following up on the other question about Mini, is that something that you believe will be appropriate for outpatient use, because the outpatient sort of thing hasn't been one where you've had great success historically.

Well, outpatient has been growing for us because there is a good application for the full thickness in outpatient. The answer is yes. That's one of the reasons we developed it, and one of the benefits of the RECELL GO platform. Those sub-480 square centimeter wounds do get treated often in outpatient. It will help us, our competitive profile, so to speak, in terms of alternative treatments in outpatient.

Okay. That's all. We'll see you next week. Thank you.

Okay, looking forward to it.

One moment for our next question. Our next question comes from the line of Chris Kallos at MST Access. Your line is live.

Thank you. Hi, Jim. Just a quick question about seeing mark and how you're seeing the market in Europe unfolding, is there any preliminary feedback from distributors in Europe about the appetite for RECELL GO?

Yes, there is, Chris. It's a good question. RECELL GO is -- since it requires less training for the company and for the user, our third-party distribution partners are quite looking forward to RECELL GO. Now, we are proceeding with early launches of the manual version of RECELL GO in this quarter. However, we think the expansion will be during the coming year. So, RECELL GO will really help the adoption curve for RECELL in Europe and in Australia.

Thanks, Jim. And just a related question, in terms of the delay in seeing marked clearance, what does that mean for timelines in launching the RECELL GO in Europe next year?

We're in the final stage of review during this month, Chris. And when you pass through the final stage, it becomes a one- to two-month administrative process versus a review process. So, I think we'll see RECELL GO during Q1 as a confident place to be. We had expected to have this review in November. We had expected it to be in August. As you know, the MDR process is a little bit overwhelmed and they just had great difficulty with the notified bodies getting all the work done that needs to be done in the industry. So, we fell, so to speak, a little bit of victim of that, even though we tried really hard to avoid it.

Yes, I understand, I understand. And just lastly, the Vitiligo initiative, has anything changed around the timeline previously put out?

Well, to remind others who might be listening, Vitiligo, we expect the two studies as I mentioned, to be accepted for publication by the end of this year, and be published either late this year or early next year. Those are foundational in getting commercial insurance policy, which we expect it will take us into the end of the third and fourth quarter of next year. So, we've not planned and don't intend to guide to any significant Vitiligo revenue during '25, but rather think that it will be a '26 event. So, that guidance is the same.

Great, great. That's all I had. See you next week also.

Look forward to it.

Thanks, Jim.

Thank you. That concludes our question and answer session. I would now like to turn it over to Jim Corbett for closing remarks.

I want to thank all of you for listening and attending our call and hearing about our results, which we are really excited to share with you. I look forward to engaging you again in one quarter's time with the fourth quarter and the further progress we expect. Thank you very much.

Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.