AVITA Medical, Inc. (RCEL)
NASDAQ: RCEL · Real-Time Price · USD
4.460
+0.130 (3.00%)
At close: Apr 24, 2026, 4:00 PM EDT
4.450
-0.010 (-0.22%)
After-hours: Apr 24, 2026, 6:02 PM EDT
← View all transcripts

Piper Sandler 37th Annual Healthcare Conference

Dec 4, 2025

Moderator

Joining us on the last day of the conference here. My name is Anna Runci. I'm one of the MedTech Associates here at Piper Sandler, and I'm pleased to introduce David O'Toole, with AVITA Medical. He's here to give a little bit of a presentation on the business, and I will turn it over to you.

Thank you.

David O'Toole
CFO, AVITA Medical

Good morning, and thank you for coming this morning early to hear our presentation. My name is David O'Toole. I'm the Chief Financial Officer of AVITA Medical. I've been with the company for a year and a half now, or two and a half years now. I'm here with our VP of Investor Relations and Corporate Communications, Ben Atkins, and I'm excited to be here to talk about AVITA Medical as we wind down 2025, which has been a challenging year for us, we have to admit that. We, the executive management of AVITA, and the board, and our new CEO, Cary Vance, and the entire company are excited about what we're going to do in 2026, and that's what we're going to talk about this morning. This is our disclosure statement. Please review. So AVITA Medical is a therapeutic acute wound care company.

We focus on acute wounds, not chronic wounds. We focus on these events, these unpredictable events that need our solutions to help the patient get out of the hospital quicker and to get home to their family and to heal as quickly as they possibly can. These events are burns, are gunshot wounds, are road rashes from car accidents, etc. They're acute, they're unpredictable, and our products that we have, which are a portfolio of products targeted on the same wound, the same patient, the same doctor, the same hospital. At the center of that portfolio is RECELL. RECELL was approved by the FDA in 2019. It's a first-in-class product.

It is spray-on skin cells, which we're going to talk about later, but it is a product that is now being used in almost all of the burn centers across the United States and in about 50-60 trauma centers. We also have two other products, Cohealyx, which is a collagen-based dermal matrix, and we have PermeaDerm, which is a biosynthetic dressing, and we're going to talk about that a little later also. We have some significant data that has recently been presented at the British Burn Association and also the European Burn Association around length of stay. There's a study that we have had that was put together on 6,300 burn patients, real-life patients out of the U.S. burn registry, where it shows that using RECELL will get that patient out of the hospital 36% quicker and get them back to their family and heal faster.

We have cost discipline. We took out about $10 million of costs annually in the second quarter, transformed our sales team, took some G&A out also. So we are at a place with our SG&A where we're scaled for growth. We don't see our costs going up over the next 18-24 months. I've talked about that. So our products, I want to talk a little bit about RECELL. RECELL is, again, it's a spray-on skin cell. We use a small autologous skin graft, about the size of a credit card. That skin graft, the cells are disaggregated, put into our special solution, and it's sprayed on the patient's wound. One cartridge is about 2,000 square centimeters, which is 10% TBSA, and we can get about an 80-1 suspension, whereas a split-thickness skin graft, it's primarily 1-1.

Cohealyx is, again, the collagen-based dermal matrix that we have, it's bioengineered with our partner, Regenity. They are the contract manufacturer. We share ASP with them, 50/50. It does tend to reduce our gross margin, but at the same time, we don't have a lot of additional costs associated with Cohealyx, and therefore it increases our operating margin and also our operating profit. PermeaDerm, similar. It's a biosynthetic wound dressing. It's porous, and it's see-through, so the doctors can see what the wound is doing while the dressing is on. It doesn't have to be removed to see how the wound is healing. Lets air in and exit out. We have an arrangement with a company called Stedical, where we share in that ASP 60/40, and we manufacture that product in our state-of-the-art facility in Ventura, California.

Our products can be used singularly, or they can be used in a single integrated platform. PermeaDerm can be used as a temporizing when the wound is first presented, and then Cohealyx will be used as a dermal matrix to build up that wound, get it ready for graft. RECELL and RECELL GO Mini will be used to spray on the skin, and then you can put PermeaDerm on again after the dressing, after the graft is completed. This is how it looks, and we're all about data, and these wounds are deep, thickness wounds, and many times you need to have a dermal matrix. That's where Cohealyx comes in. Our preclinical work has shown that we can be graft-ready in the range of 7 - 10 days, whereas our competitors are in the range of two to four weeks.

That gets the, again, the surgeon can have that patient be ready to be grafted very quickly, and once they're grafted, they can get out of the hospital, and we're showing that they can get out of the hospital quicker. RECELL, I've already talked about it. We use a very small part of donor skin, up to 97.5% less donor skin than a typical skin graft. PermeaDerm promotes the wound healing and typically within 7-14 days. Again, all focused on getting the patient out of the hospital as quickly as possible. These products are very accretive as far as revenue for us. They can be used, again, separately, or they can be used all together on the same wound, same patient, same doctor, same hospital.

PermeaDerm could be used in a partial thickness wound where it's not deep, and this example is in 4,000 square centimeters, which is about 20% TBSA, and you would use it twice, probably, in that situation. Use it once as a temporizing dressing, and then after care, you'd use it again. And that would, if only used PermeaDerm, it'd be $8,000 ASP for us. In a deep, partial thickness wound where you might need to use, you'd use RECELL and PermeaDerm, in a 4,000 square centimeter wound, you'd have two of our products, RECELL, and then an additional, you'd have PermeaDerm used on top of that, could have an ASP of around $21,000. And with Cohealyx, Cohealyx is a product that has an ASP of around $12-$15 per square centimeter.

So with a 4,000 square centimeter wound, you would have somewhere in the range of $30,000-$40,000 used for Cohealyx. RECELL, a couple of cartridges, plus PermeaDerm used a couple of times, and you can approach $60,000 for one procedure of ASP total. It has been a tough year for us. We ran into some reimbursement issues. Quick background, last year, AMA sent to CMS what they thought was going to be the CPT-1 code for the use of RECELL for reimbursing the surgeons, not for our product specifically, but for when the surgeons actually use RECELL. CMS sent it back to AMA and said, "No, this is too complicated. We'd like you to redo it." They're going to go back through RUC in January and probably won't have that CPT-1 code completed until January 1, 2027.

In the meantime, CMS assigned it to the MACs, Medicare Administrative Contractors, and they should have been adjudicating those claims starting January 1st, but that didn't happen. The MACs, for one reason or another, were not paying the claims, and we didn't catch on to this until about the 2nd quarter. When it did happen, all hands were on deck. Our prior CEO went to Washington, met with Congress, met with CMS, met with the MACs, and we got some movement of them actually publishing the prices and starting to adjudicate the claims. This slide needs to be updated for one. We just got another one that has actually published the rates, the other three, so we've got four that have published and three that have said they're going to publish in the near future.

But what that did for our demand for our product was reduce demand for the first 10, 12 months, or 11 months of the year. The surgeons didn't know when they were going to get paid or if they were going to get paid, so they stopped using RECELL as much as they were previously. We've done some analysis, and it comes out to be somewhere in the range of $10-$12 million of revenue that we believe we lost because they were not using RECELL. They were just using split-thickness skin grafts. This is behind us. It was definitely a headwind in 2025, but it's going to be a tailwind going into 2026. So we are all about now execution, and we're focused on acute wounds, burns, trauma, surgical repair. We need to accelerate revenue growth in the U.S. We need to build back RECELL order momentum.

Our commercial team is out in the field educating the surgeons again that this reimbursement issue is no longer an issue and the need to start using RECELL because it's better for the patient, better outcomes, and better for the hospitals because it gets the patient out of the hospital quicker. We're driving our Cohealyx. Cohealyx is in about half of the facilities that we are focused on, which is about 200. They're in value analysis committee. As they come out, we know that those hospitals will start ordering Cohealyx. It does take time. It takes one, two, six months to get that through a VAC, but as it does, 2026 is set up for a big year with Cohealyx. We do our international. We do have some international. We have CE mark for our new product, RECELL GO.

It is approved in the E.U. and the U.K., and we are in the process of getting approved in Australia. We expect TGA approval sometime in this next month. We go to market internationally through distributors. We're not building out a commercial team. We're doing it through third-party distributors. We do give up, obviously, margin on that, but we don't want to spend our money building out a sales team internationally until it's proven. Significant amount of issue, a burden on the healthcare system. There's over 40,000 Americans who are hospitalized with burns annually, and that's only for burns. Trauma is even probably more than that. It's a large healthcare cost, over $28 billion in healthcare cost, and what we're trying to do is have the patients get out of the hospital quicker, heal quicker, have shorter stays, and manage those costs within the healthcare system.

Our TAM is large. If you include every trauma center in the United States, it's $3.5 billion. What we're focused on is 200 key burn centers and trauma centers. The burn centers are about 130. Trauma centers are in the range of about 50. We're only tapped into about 5% of that TAM at this point. From the burn centers alone, which we've been in for about five years, our market share is about 15%-20%. So there's a significant amount of room to grow over the next few years. I'm going to move on. Wanted to touch base on this data, that a couple of things on data. This study that we did for 6,300 burn registered patients, it proved that using RECELL, you can get out of the hospital six days earlier than if you didn't use RECELL. Just use a split-thickness skin graft.

We have two post-market studies that are ongoing. Cohealyx One, which is to show the effectiveness of Cohealyx. This is a post-market study. We're going to be starting presenting that data as early as January at the Boswick Burn Conference. PermeaDerm One, again, is about a 40-patient study to prove the effectiveness over allograft, which is cadaver skin. It's all about the patient, and I never want to forget that. That's why I came to work here. This was a patient that came in with a 10%, 11% TBSA on her upper body and face. They tried allograft first, and it failed. She had to be readmitted into the hospital. They used RECELL only, spray on skin cells to her day one. Day nine, you can already see pigmentation coming back, and she was released on day 10, 11.

One year later, you can see that all of the pigmentation is back. She is just one of many patients that we have that show that our product gets that patient back to the way their life was before they had the accident. Really quickly, we had a tough quarter. We think we're at the trough. We were down 13% year over year at $17 million of revenue, primarily caused by the headwinds of reimbursement. Our gross margins are large. We have gross margin for RECELL. Our RECELL products are in the range of 84%. That's going to be consistent. Our gross margin is going to go down because of the mix of the products between Cohealyx and PermeaDerm.

As we have more of those products being sold, our margin's going to go down, but our gross profit's going to go up, and our operating profit's going to go up. We're very strong on cost discipline. We've decreased our cost 24% year over year. $23 million of expenses is in the range of where we're going to be for the foreseeable future, and our net loss continues to decrease. Cash use, we have $23 million on the balance sheet as of September 30th, and we had a 40% decrease in cash use from Q2 to Q3. We see that continuing, and we are on a trajectory to get to cash flow break-even and profitability sometime in 2026. We've grown, and this is the last slide. We've grown at a rate of 29% for the last five years. We need to get back on that trend.

We only grew 14% year over year. Our guidance for this year is $70 million-$74 million with a range of right in the middle of $72 million. 2026, we're going to give revenue guidance and many other metrics in the first part of January. I know I'm out of time, so I'm going to stop there. Thank you for your attention.

Powered by