All right. I am going to get going. All right, perfect. Thank you, everybody, and I would like to welcome the AVITA Medical team to the stage today, and thanks again for joining us. It has been a few years since we have had you guys do this, and it is always great to get the update on the business, and so much has changed. Quick disclaimer, folks should go to the Morgan Stanley website to get that. I would like to welcome Cary and David back to the stage. Cary, I would like to start with you, since you have stepped into the CEO role last October. What have you learned about AVITA that investors may not fully appreciate yet?
Yeah, I think it is a combination. Being on the board for a few years prior to taking over, I think you can appreciate either the problems or the potential. I think that the good news is that the problems were few and fixable. The other good news is that there is a tremendous amount of potential and some great people there, and I do not think investors can really know that, given where they are at. My role over the last nine, 10 months is to make sure that those problems do get solved, that the potential gets made the most of, and that our people understand where we are headed so that we can get the kind of results we have gotten over the last few quarters.
Okay, great. What would you say is the most important operational changes that you've made, and how are they affecting and improving the execution of the business?
I think at a company this size and at this stage, it's just important to focus, and I think that we focused on the right operating mechanisms. We did away with a lot of the distractions and disruptions, I think.
Yep.
It's deciding what not to do. It's putting everything from compensation plans in place to the right structure organizationally. Ge tting the right people in the right seats to execute, and to make sure that the messaging is very consistent, internally and externally. It's very much the same in that we're going to execute, and we're going to be all about growth going forward.
Okay, wonderful. Look, you said growth and you certainly have delivered growth. The last three quarters have seen strong sequential growth.
Yes
You all raised the 2026 guidance. What in your mind is the reason for this greater consistency in delivery on that top line?
One of the first things I did is really try to understand baseline, what is happening at the company. Are we aware of how our customers buy, why they're buying, why they're not buying? Then seek to become very predictable, to be able to understand what's going to happen and forecast accordingly so that you can impact that forecast along the way. I think for us, we remain in an acute wound care space where our patients are those that suffer incidents and events in any point and time, where we're very consistent as to how they're treated, but also how our people address that need in the marketplace.
Okay, wonderful. If you could point to a couple of things that investors should monitor
Yep
as they see over the next four to six quarters to judge how sustainable the progress has been, what would you point to?
Yeah. I think for the last nine months, we've been saying we have an OpEx line that should stay consistent at least, that we should, as a result, burn less cash, and that we should be judged mainly on our growth.
Right.
We believe that we're early days with a lot of growth potential, and that quarter after quarter, we have grown and they should expect us to continue to grow sequentially.
Okay, wonderful. Look, I think it would be good to spend some time on the commercial execution itself. If you think about the productivity of the commercial organization today, how would you characterize it, and what opportunity still lies ahead?
We are extremely efficient. Again, to point out that our OpEx, as we grow, we should not have to grow our OpEx accordingly. But extremely efficient, so we are talking to the same physician, the same hospital about the same patient, the same wound. Very efficient in that conversation that they have every day. From an effectiveness standpoint, when you have a product like RECELL that is pioneering, that is innovative, that changes the way they practice medicine and the way that patients heal, you gain a lot of trust in that process. You become somewhat of a consultant there. It is not just the efficiency of that call point, but the effectiveness of being able to talk about using RECELL in different types of cases. Once you are using RECELL, you should try Cohealyx, you should try PermeaDerm. The efficiency and effectiveness of our sales team is extremely effective.
Okay. If you could talk about some of the barriers for adoption of RECELL. What, in your mind, still are the remaining barriers?
Any time that you're trying to get expansion or introduction of a new product, you need to really hit three points. One is there needs to be a clinical argument. That's kind of table stakes. It needs to be good for the patient. And demonstrable, and from a data perspective. Workflow needs to be either improved or at least baseline for them. Then there needs to be an economic discussion as well. When you think about standard of care, how physicians are used to treating patients, if they are used to doing something and they have habits in that way, you have to open up their minds, and the way you do that is in those areas.
For example, in RECELL, you point to the clinical data, you point to the effectiveness and the speed of healing for the patients, the better pigmentation, the better pliability, the less scarring, all the clinical side. Then you point to the fact that 36% reduction in length of stay not only helps that patient and their family get back to life, but it also demonstrates for the hospital a reduction in beds needed, a staff, and then cost per patient. You make that argument to open up their mind to a different way, and then you use also peers that have that kind of experience, and it results in changing behavior and changing an openness to the standard of care in that hospital.
That's great. As you think about growth opportunity, there's one going deeper in centers where you are already present.
Yeah
Versus adding on new accounts. How do you think about breaking down the near term and maybe midterm growth opportunity between going deeper versus adding new accounts that you are all present in?
Yeah. I think right now we're focused on the accounts we're in, because as I said, it's not thousands, but it's 200.
Yep.
But there's plenty of room to grow there. If you look at the penetration rate that we're in and the market share we have across the three product lines, a ton of room to grow. So that's where we're focused for the foreseeable future. It doesn't mean that in the future that we won't have other things that we look at, but we're very focused. Again, a company like this, at this stage, how we got here this year to date
Yeah
and how we will get even further on the growth trajectory in the next year and a half or so is the focus where we're at.
Okay. If you could define for us, how do you think about what are the highest utilization accounts, and how transferable is the playbook to move accounts to be into that high utilization category?
Yeah, I think there's been a shift for us internally where initially, as you can imagine, as I took over, I wanted to know why people weren't using it o r why they weren't using it more. I think that's shifted also in association with that.
Yeah.
We continue with that to why do you use it? Why do you use all three products? We have 25 accounts that are using the whole portfolio across all three product lines. Why do you use it? What's your experience there? Do you see synergistic effects between the 1 + 1+ 1 equals five?
Right
kind of a situation. We make sure that we're engaged with our customers to understand our value there, not believe what we think our value is, but ask them what our value is.
Okay. There has been some reimbursement changes, meaning the proposed 2027 national physician reimbursement framework has come out. How do you think about its impact on RECELL's adoption and predictability of that revenue stream?
Yeah, I think that last word you used, predictability, is most important. Even though financially there are parts of it that are more robust. It's the permanence and the stability and consistency that they can count on. They're used to that Category I code. They're used to the simplicity of those four family groups. They're used to billing in that way. They can count on it. If they shift their practice, they know that this is what they're going to get paid in the foreseeable future.
Okay. You touched on this a little bit, but I view you guys as a true platform story.
Right
You have RECĒLL, you have Cohealyx, you have PermeaDerm. How do you think about having all three strengthening the productivity of your commercial organization?
Yeah. Again, it's not just efficiency, but I really believe that they have a portfolio to offer. If you picture a patient coming in to a burn unit or to a trauma center, from the day they come in to the day that they leave, we can impact that organization more than any other company. From an economic standpoint, and also from a clinical standpoint. Again, when you are a company that's very unique and you have a product that's very unique in RECĒLL, you build up a level of trust and even a level of gratitude with customers to some degree.
So thank you for helping me change the way I practice from a spray technology versus just a flat skin graft. That earns you some credibility and some confidence so that when you introduce the rest of the portfolio, they're listening. I think it helps them be not only, like I said, efficient in terms of the same call point, but really productive. Every time they are in the OR, they have multiple things to talk about
Yeah
even on that specific patient.
Okay, great. Look, I think the recent performance is very exciting for investors. But there is always the question of how do you have confidence that the recent performance is durable versus
Yep
a bit of variability.
I think it's understanding what's happening. I understand, on a weekly basis, daily basis, what is happening in our accounts, who is buying what and why. What are they using it on? I think it's important for me to be in that level of detail so that I can plan and predict going forward, and that I can make whatever changes need to be made, or I can communicate with investors.
Yeah.
Everything we're doing now is very organic, very consistent. Very predictable. And the business builds on itself. If you take a particular physician that starts to use Cohealyx and has a good experience, they're using it in Q1 and Q2 and Q3, and maybe even more so.
Yeah.
So kind of the baseline for our business, the reason why we say we're going to grow sequentially, is because we kind of take most of the business that we have in Q1 and say that's going to happen plus-
Right
in Q2. So I think that's why we feel confident, and we try and express that going forward.
Okay, great. I think I want to spend a little bit of time on the products and the market opportunity. Across burn, trauma wounds, and surgical repair, where do you see the greatest incremental opportunity over the next three to five years?
We are expanding into trauma and surgical repair because we do have RECELL GO mini which addresses smaller wounds, and that's a product way of addressing that. There are other ways, from education to the economics. But truly, our sweet spot is in burn. We're known as a burn company, and we're fine with that because even though we're expanding to other spaces, burn, we still have a tremendous amount of penetration. Our products are probably best in burn, best in larger burns, and so we'll continue to focus on burn until we've got it all. But we can do two things at once.
Okay, great. We talked about this in the past, but how do you balance penetrating existing indications versus going after new indications?
Yeah. Again, I think it's a matter of focus. We don't balance, we focus. For us, it doesn't mean that there aren't a handful of us at the company
Yeah
that look at new indications, new geographic opportunities, new products. We look at that. But we can do both of those things. 95% of the company is focused on this space at this time, this quarter, getting that business. So we're very focused on the indications we have, the sites that we have, and I think that's required for execution. And thus far this year, that has proven to be successful.
That's great. We've talked about RECELL GO and GO mini being very important parts of the portfolio.
Yeah.
Can you talk to us a little bit about how they've been playing a role in expanding utilization for you all?
Sure. You can imagine that over the years, there's a lot of physicians that have learned the technique around RECELL ease of use. That manual technique, and they love it. We continue to sell it to them. But you can imagine also that new physicians, younger physicians, those that are new to the space, they are attracted to the automated and consistency of RECELL GO. That is kind of the future for a lot of them. RECELL GO mini, again, listening to our customers about why they might not use it on smaller wounds, and some of it is the cost of it or whether or not the RECELL GO is built for those smaller wounds.
RECELL GO mini is an answer to that, less expensive, built for those smaller samples of skin to process and use. From a product standpoint, that addresses that, along with education, along with peer. We had an account for smaller wounds. It is not just RECELL GO mini that addresses it. We had a larger account of ours that changed their protocol from anything above 20% TBSA to anything over 10%, and that was because of the 36% reduction in length of stay data.
Okay. On clinical data, you had some very exciting data on Cohealyx.
Yes
As the clinical results came out. Can you talk to us a little bit about that data? What did it demonstrate, and how do you think that can help support adoption in the future?
Yeah, to us, we have a tagline, "Healing at the speed of life. Speed helps everybody. It helps that hospital to get patients back home sooner because it costs a lot to take care of an acute wound care patient. You can imagine it. The patient itself, the faster you can get in and out, and their family and so on. But the Cohealyx one data basically says this, that if you have a patient and you're trying to prepare the wound bed for grafting, it's going to do it sooner than the competition.
Yeah.
The data shows on average 11 days versus 31 days for the competition, as few as five days. So that readiness to graft is important. Then you lop on top of that RECELL healing faster, reduction in length of stay. 1 + 1 is you're out of the hospital days or even weeks sooner, potentially.
Okay. Maybe we'll go to PermeaDerm next.
Okay.
Clinical and economic evidence has been interesting there. How does that affect your view of its commercial potential?
Well, sometimes things are really simple. You have a product in Allograft that has been effective for years. People are used to using it to temporize the wound. But sometimes it just doesn't make as much sense when you have a product like PermeaDerm that is easy to handle, store, versus Allograft that you have to freeze, thaw, track, a product that's opaque. If you think about putting a temporizing dressing over a wound so that you can assess that wound, I think it's important that it's transparent, and you're able to see the wound.
So being able to see the wound, being able to handle it, and oh, by the way, it's a third to half the price of the Allograft. It's a matter of, I think, clinicians seeing that data, seeing it's comparable in terms of effectiveness, along with the reduction in cost and spend. I think we'll be able to make some really good traction in the market.
Okay. I think it comes to an ultimate question of how should investors think about you, right? Are you a RECELL story, or are you a broader acute wound care platform?
I would say we're a healing. We're a healing company, right? Because I think that you take all three of our product lines across the portfolio, we speed healing, we enhance healing a better way. We're not about just wound closure. We're about healing effectively for the sake of our patients, healing them cosmetically, healing them clinically. And I think from an economic standpoint, we have the opportunity to not only do that for the patient. But also save that hospital money and have a robust reimbursement platform that physicians can count on.
Okay. Wonderful. Look, maybe we'll spend a little bit of time on the financial model next, now that we've gotten a good overview of what's driving top line. David, there's been a pretty impressive reduction in costs. How do you think about that cash burn profile? And what supports your view that the cash flow profile is going to continue to improve and we'll reach cash flow breakeven by Q4, which I think has been the target timeline?
Yeah. Thanks, Nia. Last year, we put in place a kind of a rescaling of the company. It was April. It was the second quarter of 2025. We took a look at all costs across the entire company, and we took out $10 million of OpEx, $2.5 million per quarter. Right now, we are structured around $24 million per quarter of OpEx, and we don't see that growing.
Yeah.
We're scaled for growth right at the moment. We don't think we have to add additional salespeople to cover the territories we have. We're going to be looking at that even closer and potentially reducing our OpEx even some more over the next couple of quarters.
Okay.
We want to try and get as efficient as we possibly can. We burned a good amount of cash in the first quarter of this year, primarily because we had one-time payments that happened in the first quarter around compensation and benefits. We took that cash burn down to $3.2 million in the second quarter, and we see that trend continuing in the third quarter to a point when we get into Q4, where we're going to be generating cash.
Okay.
We increased our revenue guidance from $80 million - $85 million - $86 million - $89 million. With that increase, and with the revenue that we are going to be generating this quarter and next quarter, we can see a pathway to cash flow breakeven and generating cash, and it will be a huge milestone for this company. It is a huge milestone for many small companies
Yeah
to become self-sustaining, and that is our goal, is to become self-sustaining, starting in the fourth quarter. With our revenue growth sequentially every quarter this year and going into next year, we see us generating a significant amount of cash next year.
Okay. I think for investors, to your point, it has always been a focus on both how do you continue to deliver exciting top-line growth, but also making sure that the business is on a pathway of sustainability. If we think about the operating leverage that investors can expect to see out of the business as it continues to scale, do you feel like you have enough infrastructure in place to support a larger business? How do you think about that balance of delivering top-line growth versus margin expansion and pathway to cash flow generation?
Yeah, I will comment a little bit, and I know Cary has a couple of comments he would like to make also. For us, again, we think we are at the right level of commercial team to focus on the 200 burn centers. There is a lot of opportunity within those 200, 125 burn centers and 60 or 70 trauma centers. So we have the right structure in place, and the operating margin or operating leverage we are going to get is we are at 86% gross margin for RECELL. We do get some degradation of our overall gross margin because of the revenue share arrangements we have for Cohealyx and PermeaDerm, but we do not see that going below 80%.
Yeah.
We think we'll be in the 82% range. As our revenue grows, our OpEx stays the same. That operating leverage is all going to drop to the bottom line. But Cary, I know you.
No, the key is we're built to grow. We're not starving ourselves to get to cash flow breakeven. Cash flow breakeven, cash flow generation, at some point, profitability is going to be built on growth.
Yep.
Our job in parallel to that is to make sure we're responsible about what we spend, what our return on investment is. Our commercial people and other people in the organization that have strategic and tactical things to accomplish over the next couple of years know that they can get the resources they need, as long as there's a business case for doing it. We will support that to make sure that we grow, and we're not restricted in any way.
Okay. Wonderful. I think it's always helpful for investors to have a little bit of a framework around what they perhaps have gotten wrong in stories. If a new investor was to assess AVITA today, what do you think is kind of the typically most misunderstood part of the growth opportunity that the company has, as well as kind of the general financial trajectory of the company?
I think it's a simple story to understand, and I think that it got complicated last year by some reimbursement challenges that were outside the company's control, as well as I think some expectation setting that there was going to be a speed to adoption of Cohealyx and getting through value analysis committee and all of that. I think the company has been on a great trajectory the last five years that got interrupted last year. I think as time goes, we'll see 2025 as a one-off.
We grew at 11%, not terrible, but not what was expected. I think we're back on that track. I think people should understand that this company is completely under-penetrated, high value, high margin, really disciplined OpEx. At some point, no cash burn. I think it's really talented. We have not just talent in the company, but passion in the company. I think we have credibility in the marketplace. When I say marketplace, I mean with our physicians and customers.
Yeah.
I think we lost some credibility last year externally, but I think we're getting that back gradually as we execute, and I think we maintain this very strong relationship. Because at the end of the day, physicians and customers, this is a customer-centric organization.
Yeah.
And no matter what happens, they find value in RECELL.
Yeah.
They find value, increasingly so, in Cohealyx and PermeaDerm, and I think that is going to be the key to success, and it's on us to feed that going forward, and that's what we intend to do.
Okay, great. I mean,
Yeah, let me just jump in. A new investor, I think, has to look at our company and go, we've been here in the U.S. for five, six years now, right? It's taken us a while to get to where we are, and there have been a lot of reasons why it's taken us this far. But we have a large total addressable market that we're under-penetrated on. Whatever that TAM may be, and there can be arguments about what that is, but it's somewhere in the range of $1 billion for all three of our products. We're only scratching the surface here, even after five years. If I talk to a new investor, I want to tell them, "Don't look at the history. Look at us going forward
Right
because we have so much opportunity in front of us with our three products.
Okay. Maybe that's a great kind of jumping off point for my last question, which is, I always think it's helpful to give investors milestones that the company is focused on for the next 12 -1 8 months. So maybe as part of your concluding remarks, you could give folks two to three things that they should look out for as what you view as key milestones for the company over the next very near term.
Yeah, I think we've talked about some of them. One is cash flow breakeven, cash generation in Q4 is a huge milestone. I think there are a lot of companies that would trade places with us to have FDA-approved products, to have Category I reimbursement products that prove themselves economically to our customers. But ultimately, if you just look at the financial performance of the company, number one, we do what we say we're going to do.
Yeah.
We have a history, maybe I've been here 10 months or so, but everything that we've said every quarter has happened. I think that going forward, they should watch how we grow, how much we grow, why we grow. They should ask us to explain why we're growing, why we expect to continue to grow, so that we can explain those things, and then they happen so that that credibility continues. Again, cash flow generation in Q4 and into 2027, as well as sequential revenue growth each quarter by product line.
Okay.
Yeah, I don't have anything to really add on that because those are the milestones. The only one that I would potentially add is we will be profitable from a GAAP standpoint at some point. As our revenue continues to grow, we talk about the leverage on the operating expense that we have. It's only natural that that is going to, at some point-
Right
get to a positive bottom line, and we will be there. We're not projecting when that's going to happen at this point. That's a milestone that we will continue to work towards. You'll see it every quarter, that we're going to get closer to that number.
Okay, wonderful. Well, Cary, David, it was great to spend some time. Congratulations on the recent performance and strength in the business. It's been phenomenal to see, and we'll keep looking out for those upcoming milestones.
Perfect.
Thanks again.
Thank you.
All right, thanks, Nia.
Thanks again, Nia.
Thank you. Thank you.