Q2 2025 AVITA Medical Inc Earnings Call

Speaker #2: Good day and thank you for standing by. Welcome to the AVITA Medical second quarter 2025 earnings conference call. At this time, all participants are in listen-only mode.

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Speaker #2: I will now hand it over to our first speaker today, Ben Atkins, Vice President Investor Relations. Please go head.

Speaker #3: Thank you, Operator. Welcome to AVITA Medical's second quarter 2025 earnings call. Before we begin, I would like to introduce myself. My name is Ben Atkins and I started at AVITA in July leading investor relations and corporate communications.

Ben Atkins: My name is Ben Atkins, and I started at AVITA in July, leaving Investor Relations and Corporate Communications. With many years of working in life sciences, I am thrilled to be part of AVITA and this team, and I look forward to working with our investor community. 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 at www.avitamedical.com under the Investor Relations section. Before we begin, I would 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.

Speaker #3: With many years of working in life sciences, I am thrilled to be part of AVITA and this team, and I look forward to working with our investor community.

Speaker #3: Joining me on today's call are Jim Corbett, Chief Executive Officer, and David OToole, Chief Financial Officer. Today's earnings release and presentation are available on our website at www.avitamedical.com.

Speaker #3: Under the investor relations section, before we begin, I would like to remind you that this call includes forward-looking statements within the meaning of the private securities litigation reform Act of 1995.

Speaker #3: 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 statement.

Jim Corbett: 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. Good afternoon to everyone joining us in the US, and good morning to our colleagues and investors in Australia. We have a lot to cover today. I want to begin by grounding us in what defined this Q2, starting with the five key developments shown on slide 4. First, commercial revenue for the Q2 was $18.4 million, up 21% year-over-year. However, sequential revenue that was flat and impacted by a temporary headwind has become clearer to us since March.

Speaker #3: Please review our most recent filings with the SEC for comprehensive descriptions of the risk factors and your forward-looking statements provided during this call are based on management's expectations as of today.

Speaker #3: I will now turn the call over to Jim for his comments.

Speaker #4: Good afternoon to yone joining us in the US and good morning to our colleagues and investors in Australia. We have a lot to cover today.

Speaker #4: I want to begin by grounding us in what defines this quarter starting with the five key developments shown on slide four. First, commercial revenue for the second quarter was $18.4 million.

Speaker #4: Up 21% year over year. However, sequential revenue that was flat and impacted by a temporary headwind has become clearer to us since March. During the quarter, we gained a deeper understanding of a meaningful delay in how the centers for Medicare and Medicaid services and the Medicare administrative contractors implemented the conversion to the new CPT-1 codes for the use of resell which went into effect in January.

Jim Corbett: During the quarter, we gained a deeper understanding of a meaningful delay in how the Centers for Medicare & Medicaid Services and the Medicare Administrative Contractors implemented the conversion to the new CPT 1 codes for the use of RECELL, which went into effect in January. This delay, in turn, affected provider reimbursement and ultimately demand. To be clear, this is not a product issue. It's a claims processing issue, specifically around how the procedure that utilizes RECELL is valued and how payment is determined. I'll explain this in more detail shortly. Third, as a result of this reimbursement disruption and its impact on revenue, we've lowered our 2025 financial forecast. That said, we remain confident in a H2 rebound as resolution of these payment issues is already underway. More on that in a moment.

Speaker #4: This delay in turn affected provider reimbursement and ultimately demand. To be clear, this is not a product issue; it's a claims processing issue specifically around how the procedure that utilizes resell is valued and how payment is determined.

Speaker #4: I'll explain this in more detail shortly. Third, as a result of this disruption and its impact on revenue, we've lowered our 2025 financial forecast.

Speaker #4: That said, we remain confident in a second half rebound as resolution of these payment issues is already underway. More on that in a moment.

Jim Corbett: Fourth, we work with OrbiMed to secure a waiver for our Q2 trailing 12-month revenue covenant and to revise the covenants for the next four quarters, giving us flexibility as we execute against this updated growth outlook. Finally, we shared what we believe is the most consequential clinical evidence in AVITA's history. A real-world analysis of the US National Burn Registry presented in June at the British Burn Association annual meeting, including over 6,300 patients, showed that RECELL reduced length of stay by 36% for patients with deep second-degree burns covering less than 30% total body surface area. It confirms what clinicians have told us. RECELL doesn't just heal. It accelerates recovery and, in doing so, reshapes the economics of care. Since the data was presented, we've already seen interest and traction. Let's dig into the headwind I mentioned regarding claims.

Speaker #4: Fourth, we work with Orbimed to secure a waiver for our reimbursement Q2 trailing 12-month revenue covenant and to revise the covenants for the next four quarters given its flexibility as we execute against this updated growth outlook.

Speaker #4: Finally, we shared what we believe is the most consequential clinical evidence in AVITA's history. A real-world analysis of the US National Burn Registry presented in June at the British Burn Association annual meeting included over 6300 patients showed that resell reduced length of stay by 36% for patients with deep second-degree burns covering less than 30% total body surface area.

Speaker #4: It confirms what clinicians have told us. Resell doesn't just heal; it accelerates recovery and in doing so, reshapes the economics of care. Since the data was presented, we've already seen interest and traction.

Speaker #4: So let's dig into the headwind I mentioned regarding claims. Turning to slide five, in November last year, the centers for Medicare and Medicaid services or CMS announced new category one CPT codes for the use of resell.

Jim Corbett: Turning to slide 5, in November last year, the Centers for Medicare & Medicaid Services, or CMS, announced new Category I CPT codes for the use of RECELL, its rules update for 2025. Notably, CMS did not set the payment rate directly as it usually does. Instead, it assigned this task to Medicare Administrative Contractors, or MACs, through a process called contractor pricing. This happens occasionally when CMS wants to make long-term changes to a code. This work to change the code is underway and will take until January 2027. During this interim 2-year period, they can, and they did in this case, assign pricing responsibility to their contractors. When the first claims for using RECELL were submitted under the new CPT codes, the MACs should have either adjudicated the codes and made payment or denied the claim.

Speaker #4: Its rules update for 2025. Notably, CMS did not set the payment rate directly as it usually does. Instead, it assigned this task to Medicare administrative contractors or MACs through a process called contractor pricing.

Speaker #4: This happens occasionally when CMS wants to make long-term changes to a code. This work to change the code is underway and will take until January 2027.

Speaker #4: During this interim two-year period, they can, and they did in this case, assign pricing responsibility to their contractors. When the first claims for using resell were submitted under the new CPT codes, the MACs should have either adjudicated the codes and made payment or denied the claim.

Jim Corbett: A denied claim or a short claim payment then leads to an appeal and a subsequent adjudication of the code's value. However, this did not happen consistently. Subsequently, there's been a lot of healthy interaction but no conclusion on contractor pricing. The claims started piling up from January all the way through June. For clarity, we were being paid, but our providers were not. This led to the inevitable situation where providers are uncertain about what or when they will be paid for using RECELL. While enthusiasm to use RECELL grew, along with the published clinical and economic data, this uncertainty about provider payment dampened utilization. Picture a dimmer switch. That's what it felt like. The light didn't shut off, but it got dimmer every month as claims piled up with no clear adjudication.

Speaker #4: A denied claim or a short claim payment then leads to an appeal and a subsequent adjudication of the code's value. However, this did not happen consistently.

Speaker #4: Subsequently, there's a lot of healthy interaction but no conclusion on contractor pricing. The claims started piling up from January all the way through June.

Speaker #4: For clarity, we were being paid what our providers were not. This led to the inevitable situation where providers are uncertain about what or when they will be paid for using Resell.

Speaker #4: So while enthusiasm to use resell grew, along with the published clinical and economic data, this uncertainty about provider payment dampened utilization. Picture a dimmer switch as what it felt like: the light didn't shut off, but it got dimmer every month as claims piled up with no clear adjudication.

Jim Corbett: As an example, looking at our top 10 hospitals and their utilization of RECELL, compared to H2 2024 to H1 2025, we saw a reduction of approximately $5 million in revenue in those 10 accounts alone. We have determined that, in retrospect, this issue has reduced demand for RECELL overall in H1 this year by approximately 20%. There have been multi-jurisdictional efforts by members of the American Medical Association and industry to resolve this matter. Those efforts are paying off. In recent weeks, multiple Medicare Administrative Contractors have indicated their intent to adjudicate payment. We expect all the others to follow and believe that this problem will be resolved during Q3. We expect demand for RECELL to pick up again during the current quarter and through Q4.

Speaker #4: As an example, looking at our top 10 hospitals and their utilization of resell, compared to the second half of 2024, to the first half of 2025, we saw a reduction of approximately $5 million in revenue in those 10 accounts alone.

Speaker #4: We have determined that in retrospect, this issue has reduced demand for resell overall in the first half of this year by approximately 20%. There have been multi-jurisdictional efforts by members of the American Medical Association and industry to resolve this matter.

Speaker #4: Those efforts are paying off. In recent weeks, multiple Medicare contractors have indicated their intent to adjudicate payment. We expect all the others to follow and believe that this problem will be resolved during the third quarter.

Speaker #4: We expect demand for resell to pick up again during the current quarter and through the fourth quarter. As a result of this, we've adjusted our guidance to reflect the reality of the first half of the year and our ected recovery in the second half.

Jim Corbett: As a result of this, we've adjusted our guidance to reflect the reality of the H1 and our expected recovery in the H2. We've also agreed with OrbiMed to amend our credit facility. The updated terms include lower 12-month revenue covenants through Q2 2026. As part of this amendment, OrbiMed's fee was paid in equity instead of cash, demonstrating their long-term commitment and confidence in our business. David will review this and the complete financial details shortly. We've had a very dynamic H1 that has disrupted our business. The enthusiasm from hospital surgeons and patients for our products is stronger than ever.

Speaker #4: In turn, we've also agreed with Orbimed to amend our credit facility. The updated terms include lower 12-month revenue covenants through the second quarter of 2026, as part of this amendment, Orbimed's fee was paid in equity instead of cash.

Speaker #4: Demonstrating their long-term commitment and confidence in our business, David will review this and complete financial details shortly. Clearly, we've had a very dynamic first half of the year that has disrupted our business.

Speaker #4: That said, the enthusiasm from hospital surgeons and patients for our products is stronger than ever. In May, at our acute wound care showcase, we presented our vision for therapeutic acute wound care centered around the patient, with three complementary products and data to support them.

Jim Corbett: In May, at our Acute Wound Care Showcase, we presented our vision for therapeutic acute wound care centered around the patient with 3 complementary products and data to support them: one broad, integrated portfolio targeted at the same wound, the same patient, the same doctor, and the same hospital. Turning to slide 6, this is a milestone worth highlighting. In June, during the British Burn Association, the largest real-world analysis of RECELL to date was presented: 5 years of US National Burn Registry data. The results showed a 36% reduction in hospital stay for burn patients. That's not just statistically significant. It's clinically transformative. This confirms our prior studies and what clinicians have seen time and again. RECELL helps patients get home faster. Typically, these patients must stay in the hospital for a range of weeks, so reducing that time by over a third has real impact.

Speaker #4: One brought integrated portfolio targeted at the same wound, the same patient, same doctor, and the same hospital. Turning to slide six, this is a milestone worth highlighting.

Speaker #4: In June, during the British Burn Association, the largest real-world analysis of resell to date was presented. Five years of US National Burn Registry data, the results showed a 36% reduction in hospital stay for burn patients.

Speaker #4: That's not just statistically significant; it's clinically transformative. This confirms our prior studies and what clinicians have seen time and again. Resell helps patients get home faster, typically these patients must stay in the ospital for a range of weeks so reducing that time by over a third has real impact.

Jim Corbett: Why does that matter? Because every extra day in a hospital can cost more than $11,000 per patient. Multiply that by 36% fewer days, and the value of earlier discharge becomes undeniable. With shorter stays, hospitals can also free up beds and treat more patients more efficiently. The impact we're highlighting is about more than just the hospital's bottom line. Getting home sooner also improves the patient's recovery and quality of life. Let me take a moment here and share a story that's resonating far and beyond our industry. Slide 7. Abbey Alexander was 18 years old when a fuel explosion in Cambodia left her with life-threatening burns over a third of her body. She was flown to the US, where her face and arm were treated with RECELL. Today, nearly 6 years later, Abbey's thriving.

Speaker #4: Why does that matter? Because every extra day in a hospital can cost more than $11,000 per patient. Multiply that by 36% fewer days and the value of earlier discharge becomes undeniable.

Speaker #4: With shorter stays, hospitals can also free up beds and treat more patients. More efficiently, the impact we're highlighting is about more than just the hospital's bottom line.

Speaker #4: Getting home sooner also improves the patient's recovery and quality of life. Let me take a moment here and share a story that's resonating far and beyond our industry.

Speaker #4: Slide seven. Abby Alexander was 18 years old. When a fuel explosion in Cambodia left her with life-threatening burns, over a third of her body.

Speaker #4: She was flown to the U.S., where her face and arm were treated with Resell. Today, nearly six years later, Abby's thriving. Her recent before-and-after photos have gone viral on Reddit.

Jim Corbett: Her recent before and after photos have gone viral on Reddit and were featured in Newsweek and UK national media. The difference is striking: minimal facial scarring and a clear message from her. "I wish I had RECELL everywhere." Abbey's story is a powerful reminder of what's possible. This is why hospitals aren't just adopting RECELL as a product, but deploying it as a protocol for enabling faster recovery and more efficient care. Turning to slide 9, we have Cohealyx, our collagen-based dermal matrix. Cohealyx just made its peer-reviewed publication debut in the journal Surgery. The data demonstrated graft readiness in as little as 5 to 10 days. It typically takes 14 to 28 days with competitive products. This is illustrated in this case study.

Speaker #4: They were featured in Newsweek and UK National Media. The difference is striking. Minimal facial scarring and a lear message from her. I wish I had resell everywhere.

Speaker #4: Abby's story is a powerful reminder of what's possible. This is why hospitals aren't just adopting resell as a product, but deploying it as a protocol for enabling faster recovery and more efficient care.

Speaker #4: Then, turning to slide nine, we have Cohelix, our collagen-based thermal matrix. Cohelix just made its peer-reviewed publication debut in the Journal of Surgery. The data demonstrated graph readiness and as little as 5 to 10 days.

Speaker #4: Typically, it takes 14 to 28 days, with a competitor product. This illustrated in this case study. A 48-year-old man with multiple comorbidities presented with a full-thickness wound on the right hand covering 11.25% total body surface area, a sizable open wound.

Jim Corbett: A 48-year-old man with multiple comorbidities presented with a full-thickness wound on the right hand covering 11.25% total body surface area, a sizable open wound. 10 days post-Cohealyx application, the wound was skin grafted. The majority of the wound was re-epithelialized within 2 weeks post-skin graft. The patient showed strong functional recovery, per the clinician's assessment. This shortened days to graft is a breakthrough for complex wounds and leads also to shorter hospital stays. Building on our preclinical and clinical research, our post-market clinical study Cohealyx-I will assess its performance in real-world settings. The study will look at time to graft, clinical efficacy, and cost savings in the treatment of trauma wounds and burns. Study sites are enrolling and will keep you updated as the data builds.

Speaker #4: Ten days post-Cohelix application, the wound was skin grafted. The majority of the wound was re-epithelialized within two weeks post-skin. The patient showed strong functional recovery per the clinician's assessment.

Speaker #4: This shortened days to graft is a breakthrough for complex wounds and leads also to shorter hospital stays. Building on our preclinical and clinical research, our post-market clinical study, Cohelix One, will assess its performance in real-world settings.

Speaker #4: The study will look at time to graft clinical efficacy and cost savings in the atment of trauma wounds and burns. Study sites are enrolling, and we'll keep you updated as the data builds.

Jim Corbett: Turning to slide 10, I want to cover some highlights within the portfolio that we believe show momentum for our vision to transform acute wound care. Since the presentation of data on RECELL at the British Burn Association in June, two major hospitals, an academic medical center and a regional burn center, are in the process of adopting broader RECELL eligibility protocols to include all burns under 20% total body surface area. This data has resulted in transforming RECELL, the supply cost, to RECELL as a protocol treatment that results in length of stay. With this approach, we have market-tested a new strategy. This strategy is an outcomes-based partnership agreement. In this agreement, the use of RECELL has a target reduction in length of stay. If it does not achieve that result, the hospital receives a rebate. We've reached agreement with two centers since June.

Speaker #4: Turning to slide 10, I want to cover some highlights within the portfolio that we believe show momentum for our vision to transform acute wound care.

Speaker #4: Since presentation of data, on resell at the British Burn Association in June, two major hospitals and academic medical center and a regional burn center are in the process of adopting broader resell eligibility protocols to include all burns under 20% total body surface area.

Speaker #4: This data has resulted in transforming resell the supply cost to resell as a protocol treatment that results in length of stay. With this approach, we have market tested a new strategy.

Speaker #4: This strategy is an outcome-based partnership agreement. In this agreement, the use of resell has a target reduction in length of stay, and if it does not achieve that result, the hospital receives a rebate.

Speaker #4: We've reached agreement with two centers since June. This type of arrangement is driven by our belief and our resell data. It's built on a very large database of patients, so it's highly reliable.

Jim Corbett: This type of arrangement is driven by our belief and our RECELL data. It's built on a very large database of patients, so it's highly reliable. We trust it. We anticipate that these two centers alone will increase their RECELL units by approximately 150 additional patients each month. It is worth noting that even if we have to pay a rebate, which we believe will not be necessary, our revenue base has increased substantially with the treatment of these additional patients. We see this business model as highly adaptable across the country in other facilities. Across the US, RECELL is used in nearly all burn centers. As you know, during last year, we have been expanding into level 1 and 2 trauma centers.

Speaker #4: We trust it. We anticipate that these two centers alone will increase their resell units by approximately 150 additional patients each month. It is worth noting that even if we have to pay a rebate, which we believe will not be necessary, our revenue base is increased substantially with the treatment of these additional patients.

Speaker #4: We see this business model as highly adaptable across the country and other facilities. Across the US, we sell is used in nearly all burn centers.

Speaker #4: As you know, during last year, we have been expanding into level one and two trauma centers. This week, we received approval from CMS, the US agency that oversees Medicare, for a special reimbursement called the NTAP.

Jim Corbett: This week, we received approval from CMS, the US agency that oversees Medicare, for a special reimbursement called the NTAP, or New Technology Add-On Payment, for RECELL when used on trauma wounds and hospitalized patients. What does that mean? It means hospitals can now receive additional payment from Medicare when RECELL is used in these cases above an additive to the standard reimbursement. It's designed to accelerate access to breakthrough devices like ours by offsetting hospitals' cost of adopting the technology. This is a strong signal from CMS. It recognizes RECELL's clinical value and helps remove a financial barrier to adoption. The policy takes effect 1 October and will be in place for 1 year. We believe this will drive increased utilization in the inpatient setting and support further expansion into trauma and surgical wounds.

Speaker #4: Or New Technology Add-On Payment. For resell, when used on trauma wounds in hospitalized patients. What does that mean? It means hospitals can now receive additional payment from Medicare when resell is used in these cases above an additive to the standard reimbursement.

Speaker #4: It's designed to accelerate access to breakthrough devices like ours by offsetting hospitals' cost of adopting the technology. There is a--this is a strong signal from CMS.

Speaker #4: It recognizes resell's clinical value and helps remove a financial barrier to adoption. The policy takes effect October 1 and will be in place for one year.

Speaker #4: We believe this will drive increased utilization in the inpatient setting and support further expansion into trauma and surgical wounds. While the NTAP supports resell in the inpatient setting, we're also expanding access in the outpatient care.

Jim Corbett: While the NTAP supports RECELL in the inpatient setting, we're also expanding access in the outpatient care. That's where RECELL GO mini comes in. During our pre-market approval study, we saw that the average trauma wound was about 400 square centimeters. That insight directly informed the design of RECELL GO mini, optimized for wounds 480 square centimeters or smaller compared to standard RECELL, which treats 1,920 square centimeters. Now, trauma surgeons can treat smaller wounds more efficiently in the outpatient setting with the appropriate-sized spray-on application of RECELL. It's precision designed for how RECELL is actually used in trauma care, and it opens the door to broader adoption outside the hospital. A quick update on our international business. We expected CE Mark approval in Q3, but due to ongoing bureaucratic delays from our notified body, approval could move to Q4.

Speaker #4: That's where resell go many comes in. During our pre-market approval study, we saw that the average trauma wound was about 400 square centimeters. That insight directly informed the design of resell go many.

Speaker #4: Optimized for wounds 400 and 80, square centimeters or smaller, compared to standard resell which treats 1,920 square centimeters. Now, trauma surgeons can't can treat smaller wounds more efficiently in the outpatient setting with the appropriate sized spray-on application of resell.

Speaker #4: Its precision design for how resell is actually used in trauma care and it opens the door to broader adoption outside the hospital. A quick update on our international business.

Speaker #4: We expected CE mark approval in Q3. But due to ongoing bureaucratic delays from our notified body of approval could move to Q4. While this has delayed our EU and Australia launch, we are prepared to go forward with an economically lean distributor-led commercial model upon approval.

Jim Corbett: While this has delayed our EU and Australia launch, we are prepared to go forward with an economically lean, distributor-led commercial model upon approval. Cohealyx is off to a strong start since its launch in April. As a reminder, Cohealyx is a cost-competitive, margin-accretive, and has a low number of days to graft readiness. Value analysis committee submissions are pending in approximately 25% of the 120 to 130 US burn centers nationwide. As hospitals receive VAC approval, we've seen commercial momentum grow quickly. In July, we established multiple ordering accounts. In fact, our largest account ordered nearly $300,000 of Cohealyx during the month of July alone. We are really excited about the opportunity with Cohealyx. Consider this: we sell over 1,000 RECELL kits per month.

Speaker #4: Cohelix is off to a strong start since its launch in April. As a reminder, Cohelix is cost-competitive, margin-accretive, and has a low number of days to graft readiness.

Speaker #4: Value analysis committee submissions are pending in approximately 25% of the 120 to 130 U.S. burn centers nationwide. As hospitals receive VAC approval, we've seen commercial momentum grow quickly.

Speaker #4: In July, we established multiple ordering accounts; in fact, our largest account ordered nearly 300,000 dollars of Cohelix during the month of July alone. We are really excited about the opportunity with Cohelix.

Speaker #4: Consider this: we sell over 1,000 resell kits per month. If just 10% of that 1,000 each covering on average 2,000 square centimeters, instead use our Cohelix thermal matrix at its market price it would generate an additional 36 million dollars in annual revenue.

Jim Corbett: If just 10% of that 1,000, each covering on average 2,000 square centimeters, instead use our Cohealyx dermal matrix at its market price, it would generate an additional $36 million in annual revenue. To reiterate, this presents an unmatched opportunity in our marketplace. We have RECELL that can reduce the length of stay by 36%. Additionally, Cohealyx enables faster grafting 7 to 14 days sooner than our competitors. As we expand from burn to include also trauma, we have PermeaDerm, our biosynthetic dressing. We insource manufacturing of PermeaDerm to our state-of-the-art Ventura location. As a reminder, PermeaDerm acts as a temporary biosynthetic dressing to temporize wounds and manage moisture, both prior to grafting, during graft healing, and during the aftercare period of graft healing.

Speaker #4: To reiterate, this presents an unmatched opportunity in our marketplace. We have resell that can reduce the length of stay by 36%. Additionally, Cohelix enables faster grafting 7 to 14 days sooner than our competitors.

Speaker #4: Then, as we expand from burn to include also trauma, we have PermioDerm, our biosynthetic dressing. We insource manufacturing of PermioDerm to our state-of-the-art for internal location.

Speaker #4: As a reminder, PermioDerm acts a temporary biosynthetic dressing to temporize wounds and manage moisture, both prior to grafting during graft healing and during the aftercare period of graft healing.

Jim Corbett: This quarter, it was featured in 10 presentations at US burn conferences, demonstrating its application across a variety of wound types and stages of treatment until healing is achieved. This included a randomized trial showing single application and easier aftercare. Our PermeaDerm I study, now actively enrolling, is comparing the cost and clinical outcomes between PermeaDerm and allograft used in patients who need a skin graft to heal their wounds. Our excitement in the versatility of PermeaDerm, its potential to replace allograft, and its integration into our portfolio is reflected in a standout order in sales. As interest in our acute wound care portfolio grows, we're expanding access to our products through strategic group purchasing organization contracts, GPOs, and several integrated delivery networks, IDNs.

Speaker #4: This quarter, it was featured in 10 presentations at US Burn Conferences. Demonstrating its application across a variety of wound types and stages of treatment until healing is achieved.

Speaker #4: This included a randomized trial showing single application and easier aftercare. Our PermioDerm One study now active and enrolling is comparing the cost and clinical outcomes between PermioDerm and Allograft.

Speaker #4: Used in patients who need a skin graft to heal their wound. Our excitement in the versatility of PermioDerm is potential to replace Allograft and its integration into our portfolio is reflected in a stand-up order in sales.

Speaker #4: As interest in our acute wound care portfolio grows, we're expanding access to our products through strategic group purchasing organization contracts GPOs and several integrated delivery networks IDNs.

Jim Corbett: These agreements connect us to burn centers and level 1 and 2 trauma centers within those systems, allowing physicians in those facilities to use RECELL, Cohealyx, and PermeaDerm. I'd like to provide an update on the transformation of our US sales organization. To remind you, on 1 April, we redesigned our commercial organization, taking into account the need for our reps to be present at both stages of the 2-stage procedure to optimize the selling of RECELL, Cohealyx, and PermeaDerm, which are used in both stages. This is a significant change from our prior strategy, which relied on heavy clinical support by clinical specialists who had no selling role. During the implementation of this, we moved from a heavy service orientation to more of a selling orientation.

Speaker #4: These agreements connect us to burn centers and level one and two trauma centers within those systems. Allowing physicians and those facilities to use resell, Cohelix, and PermioDerm.

Speaker #4: I'd like to provide an update on the transformation of our U.S. sales organization. To remind you, on April 1, we redesigned our commercial organization.

Speaker #4: Taking into account the need for our reps to be present at both stages of the two-stage procedure to optimize the selling of resell, Cohelix, and PermioDerm, which are used in both stages.

Speaker #4: This is a significant change from our prior strategy, which relied on heavy clinical support by clinical specialists who had no selling role during the implementation of this.

Speaker #4: We moved from a heavy service orientation to more of a selling orientation. Consequently, we developed a more focused and efficient selling organization taking our field headcount from 108 to 82 people.

Jim Corbett: Consequently, we developed a more focused and efficient selling organization, taking our field headcount from 108 to 82 people, consequently saved nearly $2.5 million per quarter. The majority of the $2.5 million came from this reorganization and results in an annual reduction in our cash needs of $10 million, which we realized effectively during Q2. Turning finally to slide 7, what does this all add up to? Innovation and integration. A comprehensive wound closure solution designed to improve patient outcomes and optimize healing quickly. RECELL, Cohealyx, PermeaDerm, working in sync like an orchestra. Each product accelerates care. Together, they accelerate value. When you reduce hospital stays, you reduce costs. When you reduce healing time, patients go home to their families sooner. When patients go home sooner, you free up capacity. That's what AVITA's platform delivers and why this opportunity is unlike anything else in the market.

Speaker #4: And consequently, saved nearly 2.5 million per quarter. The majority of the 2.5 million came from this reorganization and results in an annual reduction in our cash needs of $10 million dollars, which we realized effectively during Q2 period.

Speaker #4: So turning finally to slide seven, what does this all add up to? Innovation and integration. A comprehensive wound closure solution designed to improve patient outcomes and optimize healing quickly.

Speaker #4: Resell, Cohelix, PermioDerm, working in sync like an orchestra. Each product accelerates care together the accelerated value. When you reduce hospital stays you reduce costs.

Speaker #4: When you reduce healing time patients go home to their families sooner. When patients go home sooner you free up capacity. That's what AVITA's platform delivers and why this opportunity is unlike anything else in the market.

Jim Corbett: We are a multi-product platform with eyes on a $3.5 billion opportunity. Same wound, same patient, same doctor, same hospital. Now, faster healing, better outcomes, lower costs. We've reset, and we're ready. At the same time, we're strengthening our leadership to reflect this next chapter. As you will have seen in yesterday's press release, I'm pleased to welcome Dr. Michael Tarnoff to our board. Michael was the Chief Physician Executive and CEO at Tufts Medical Center in Boston and held senior leadership roles at Medtronic and Covidien. His clinical expertise and leadership in surgical innovation will be instrumental as we scale. I want to recognize Lou Panaccio, who has chaired our board through AVITA's formative years, from early commercial milestones to where we are today. Lou's steady guidance helped shape the foundation we're now building on, and I want to thank him for that effort.

Speaker #4: We are a multi-product platform with eyes on a 3.5 billion dollar opportunity. Same wound, same patient, same doctor, same hospital. But now, faster healing, better outcomes, lower costs.

Speaker #4: We've reset and we're ready. At the same time, we're strengthening our leadership to reflect this next chapter. As you will have seen in yesterday's press release, I'm pleased to welcome Dr. Michael Tarnoff to our board.

Speaker #4: Michael was the ief Physician Executive and CEO at Tufts in Boston. He held senior leadership roles at Medtronic and Covidium. His clinical expertise and leadership in surgical innovation will be instrumental as we scale.

Speaker #4: I want to recognize Lou Panaccio, who has chaired our board through AVITA's formative years. From early commercial milestones to where we are today. Lou's study guidance helped shape the foundation we're now building on.

Speaker #4: And I want him to thank to my want to thank him for that effort. With that, I'm excited to welcome Kerry Vance, as he transitions into the chair position.

Jim Corbett: With that, I'm excited to welcome Cary Vance as he transitions into the Chair position. Cary's deep commercial and operating experience and passion for medtech innovation help us accelerate into our next phase of growth. Now, I'll pass it over to David to review our financials.

Speaker #4: Kerry's deep commercial and operating experience and passion for MedTech innovation help us accelerate into our next phase of growth. Now, I'll pass it over to David to review our financials.

David O'Toole: Thank you, Jim. For the three months ended 30 June 2025, our commercial revenue was $18.4 million, a 21% increase compared to the same period in 2024. This growth was mainly driven by the broadening deployment of our RECELL system, particularly RECELL GO, in spite of the headwinds during H1 2025 that Jim spoke about. Additional contributions came from our new products, Cohealyx and PermeaDerm, as well as the expansion from burn centers to new accounts targeting trauma centers. Gross profit margin for Q2 was 81.2%, down from 86.1% during the same period in 2024. Note that the gross margin for RECELL products alone was 84.3% for Q2, which we believe will remain in this range for future quarters.

Speaker #5: Thank you, Jim. For the three months ended June 30, 2025, our commercial revenue was $18.4 million, a 21% increase compared to the same period in 2024.

Speaker #5: This growth was mainly driven by the broadening deployment of our resell system, particularly resell go, and in spite of the headwinds during the first half of 2025 that Jim spoke about.

Speaker #5: Additional contributions came from our new products, Cohelix and PermioDerm. As well as the expansion from burn centers to new accounts targeting trauma, trauma centers.

Speaker #5: Gross profit margin for the second quarter was 81.2%, down from 86.1% during the same period in 2024. Note that the gross margin for resell products alone was 84.3% for the quarter.

Speaker #5: Which we believe will remain in this range for future quarters. The decrease in the overall gross margin percentage compared to the previous year was mainly due to product mix, a higher inventory reserve, and other adjustments.

David O'Toole: The decrease in the overall gross margin percentage compared to the previous year was mainly due to product mix, a higher inventory reserve, and other adjustments. Regarding gross margin and gross profit, we expected our gross margin percentage to decline as revenue from PermeaDerm and Cohealyx grew. As we have previously disclosed, we share the average sales price for Cohealyx at 50% and for PermeaDerm at 60%. These distribution arrangements will contribute substantial gross profit and operating cash flow but will impact overall gross margin. Total operating expenses for the quarter were $26.1 million, down from $28.7 million in the same period of 2024. This decline was mainly due to a $2 million reduction in sales and marketing costs driven by lower employee-related expenses such as salaries, benefits, commissions, and stock-based compensation.

Speaker #5: Regarding gross margin and gross profit, we expected our gross margin percentage to decline as revenue from PermioDerm and Cohelix grew. As we have previously disclosed, we share the average sales price for Cohelix at 50%.

Speaker #5: And for PermioDerm at 60%. These distribution arrangements will contribute substantial gross profit and operating cash flow. But will impact overall gross margin. Total operating expenses for the quarter were 26.1 million.

Speaker #5: Down from 28.7 million in the same period of 2024. This decline was mainly due to a $2 million reduction in sales and marketing costs.

Speaker #5: Driven by lower employee-related expenses such as salaries, benefits, commissions, and stock-based compensation. G&A expenses also fell by 0.8 million, primarily because of reduced salaries, benefits, deferred compensation, professional fees, and corporate costs.

David O'Toole: G&A expenses also fell by $0.8 million, primarily because of reduced salaries, benefits, deferred compensation, professional fees, and corporate costs. R&D expenses increased slightly by $0.2 million, mainly from higher salaries and benefits. As previously disclosed, due to our recent commercial field transformation and added operational efficiencies implemented in Q2, we reduced our operating expenses by about $2.4 million this quarter. We expect to achieve the same or greater savings in each of the upcoming quarters, translating into an annual savings of $10 million. The $26.1 million in operating expenses for Q2 include non-cash expenses of approximately $2.7 million in stock-based compensation and approximately $0.8 million in depreciation and amortization.

Speaker #5: R&D expenses increased slightly by $0.2 million, mainly from higher salaries and benefits. As previously disclosed, due to our recent commercial field transformation and added operational efficiencies implemented in Q2, we reduced our operating expenses by about $2.4 million this quarter.

Speaker #5: We expect to achieve the same or greater savings in each of the upcoming quarters translating into an annual savings of 10 million. The 26.1 million in operating expenses for the second quarter include non-cash expenses of approximately 2.7 million, in stock-based compensation, and approximately 0.8 million in depreciation and amortization.

David O'Toole: Other income expense increased by $0.9 million to $2.5 million of income for the quarter, consisting of non-cash gains totaling $1.2 million related to changes in the fair value warrants and $0.9 million related to changes in the fair value of the debt, along with $0.4 million in investment income. The Q2 net loss was $9.9 million or $0.38 per basic and diluted share, showing a 36% improvement from the net loss of $15.4 million or $0.60 per basic and diluted share in the same period of 2023. As of 30 June, our cash and marketable securities totaled $15.7 million compared to $35.9 million at 31 December 2023.

Speaker #5: Other income expense increased by 0.9 million, to 2.5 million, of income for the quarter. Consisting of non-cash gains totaling 1.2 million related to changes in the fair value warrants and 0.9 million related to changes in the fair value of the debt.

Speaker #5: Along with 0.4 million in investment income. The second quarter's net loss was 9.9 million, or 38 cents per basic and diluted share. Showing a 36% improvement from the net loss of 15.4 million.

Speaker #5: Or 60% 60 cents per basic and diluted share in the same period of 2024. As of June 30th, our cash and marketable securities totaled 15.7 million.

Speaker #5: Compared to 35.9 million at December 31st, 2024. Although the accounts receivable balance of approximately 11.3 million as of June 30th will help our anticipated working capital needs in the third quarter, we still intend to raise additional capital to strengthen our balance sheet and support our working capital needs.

David O'Toole: Although the accounts receivable balance of approximately $11.3 million as of 30 June will help our anticipated working capital needs in Q3, we still intend to raise additional capital to strengthen our balance sheet and support our working capital needs. Turning to our OrbiMed credit agreement, at the end of June, we secured a waiver for the Q2 trailing 12-month revenue covenant, which was set at $78 million. Additionally, on 7 August, we entered into an amendment to the credit agreement, adjusting the revenue covenants for the next four quarters to $73 million, $77 million, $90 million, and $103 million, starting with the quarter ending 30 September 2025. As compensation for this amendment, we issued OrbiMed 400,000 shares of AVITA Common Stock. We appreciate OrbiMed's ongoing support as they accepted shares instead of a cash fee, further demonstrating their confidence in our long-term strategy.

Speaker #5: Turning to our Orbimed credit agreement at the end of June, we secured a waiver for the second quarter trailing 12-month revenue covenant, which was set at 78 million.

Speaker #5: Additionally, on August 7th, we entered into an amendment to the credit agreement adjusting the revenue covenants for the next four quarters to 73 million, 77 million, 90 million, and 103 million, starting with the quarter ending September 30th, 2025.

Speaker #5: As compensation for this amendment, we issued Orbimed $400,000 shares of AVITA common stock. We appreciate Orbimed's ongoing support as they accepted shares instead of cash fee further demonstrating their competence in our long-term strategy.

David O'Toole: Turning to our financial outlook for the rest of the year, due to the headwinds in the H1 of the year that Jim outlined, we are revising our full year 2025 commercial revenue guidance to $76 million to $81 million from the previously estimated $100 million to $106 million. This new full year 2025 revenue guidance indicates a growth of approximately 19% to 27% compared to 2024. Additionally, we now expect to start generating free cash flow in Q2 2026 and reach GAAP profitability in Q3 2026, compared to our earlier plan of generating free cash flow in H2 2025 and achieving GAAP profitability in Q4 2025. Even with the many challenges we have faced in the H1 of this year, I want to reiterate our optimism for the future.

Speaker #5: Turning to our financial outlook for the rest of the year, due to the headwinds in the first half of the year that Jim outlined, we are revising our full year 2025 commercial revenue guidance to 76 million, to 81 million, from the previously estimated 100 million to 106 million.

Speaker #5: This new full year 2025 revenue guidance indicates a growth of approximately 19 to 27 percent compared to 2024. Additionally, we now expect to start generating free cash flow in Q2 of 2026 and reach GAAP profitability in Q3 of 2026.

Speaker #5: Compared to our earlier plan of generating free cash flow in the second half of 2025, and achieving GAAP profitability in Q4 of 2025. Even with the many challenges we have faced in the first half of this year, I want to reiterate our optimism for the future.

David O'Toole: There is clear evidence of green shoots or signs of growth across our business. These include, we finished the Q2 with June marking one of our strongest revenue months to date as visibility to reimbursement began to emerge. Even more encouragingly, revenue in July and early part of August has signaled a strong start to the Q3. From a revenue standpoint, we view the size and speed of orders we've received from our first value analysis committee, our back-approved accounts this July, as an early indicator of the potential strong demand for Cohealyx. With our proprietary position in the operating room and with burn surgeons, our ability to showcase the clinical benefits of Cohealyx is unmatched compared to our competitors. We only need to achieve back approval and convert a small percentage of procedures to see a significant impact to our revenue.

Speaker #5: There is clear evidence of green shoots. Our signs of growth across our business. These include we finished the second quarter with June marking one of our strongest revenue months to date.

Speaker #5: As visibility to reimbursement began to emerge. Even more encouragingly, revenue in July and early part of August has signaled a strong start to the third quarter.

Speaker #5: From a venue standpoint, we view the size and speed of orders we've received from our first value analysis committee, our VAC approved accounts this July, as an early indicator of the potential strong demand for Cohelix.

Speaker #5: With our proprietary position in operating room and with burn surgeons, our ability to showcase the clinical benefits of Cohelix is unmatched compared to our competitors.

Speaker #5: We only need to achieve VAC approval and convert a percentage of procedures to see a significant impact to our revenue. The new outcome-based business model discussed earlier for certain facilities where resell wasn't the standard practice for burns with less than 20% total body surface area has the potential to generate significantly more revenue.

David O'Toole: The new outcome-based business model discussed earlier for certain facilities, where RECELL wasn't the standard practice for burns with less than 20% total body surface area, has the potential to generate significantly more revenue. The facilities where we are already implementing are just the beginning of this type of business model. In closing, we are hyper-focused on executing our operating plan for the remainder of 2025. With that, I will turn the call back to Jim for his key takeaways for the remainder of the year before we answer your questions.

Speaker #5: The facilities where we are already implementing are just the beginning of this type of business model. In closing, we are hyper-focused on executing our operating plan for the remainder of 2025.

Speaker #5: With that, I will turn the call back to Jim for his key takeaways for the remainder of the year before we answer your questions.

Jim Corbett: Thanks, David. Before we open the line for questions, I want to briefly bring us back to what matters most. First, with the resolution of the claims backlog now underway, we expect full demand for RECELL to return in H2 of the year. Second, our revised guidance reflects that recovery and our momentum going into 2026. Third, the amendment to our OrbiMed agreement reinforces long-term alignment around that path forward. Finally, the real-world data showing a 36% reduction in length of stay with RECELL isn't just a clinical insight. It's a value proposition that improves outcomes and strengthens hospital economics. Put simply, we're focused, executing, and well-positioned to accelerate. With that, operator, let's open it up for questions.

Speaker #4: Thanks, David. Before we open the line for estions, I want to briefly bring us back to what matters most. First, with the resolution of the claims backlog now underway, we expect full demand for resell to return in the second half of year.

Speaker #4: Second, our revised guidance reflects that recovery and our momentum going into 2026. Third, the amendment to our Orbimed agreement reinforces long-term alignment around that path forward.

Speaker #4: And finally, the real-world data showing a 36% reduction in length of stay with resell isn't just a clinical insight. It's a value proposition that improves outcomes and strengthens hospital economics.

Speaker #4: Put simply, we're focused, executing, and well-positioned to accelerate. With that, operator, let's open it up for questions.

Operator: Thank you. Our first question will come from line of Joshua Jennings from TD Cowen. Your line is open.

Speaker #2: Thank ou. So I have a question you will need to press star 11 on your telephone and wait for me to be announced. To address your question, please press star 11 again.

Speaker #2: Please stand by while we compile the Q&A roster. One moment for our first question. Our first question will come from line of Josh Jennings from TD Callen.

Speaker #2: Your line is open.

Joshua Jennings: Hi. Good afternoon, Jim and David. Thanks for the download and for taking the questions. Just in terms of the resolution and the backlog of claims, it sounds like it's in process, I should say, in July. Maybe just take us through, if you would, just a couple of different scenario analyses. I mean, how quickly can all the MACs get on board? Maybe just give us an understanding of just how many claims, what percentage of claims were being denied in H1 of the year, if there is a percentage, and where that stands now in July and any improvement pace that's been documented already and how you expect that to play out over the coming months.

Speaker #6: Hi. Good afternoon. Jim and David, thanks for the download and for taking the estions. Just in terms of the resolution and the backlog of claims, it sounds like it's in progress, in process, I should say, in July.

Speaker #6: Maybe just take us through, if you would, just a couple of different scenario analyses. I mean, how quickly can all the MACs get on board?

Speaker #6: And maybe just give us an understanding of just how many claims, what percentage of claims were being denied in the first half of the year?

Speaker #6: If there is a percentage and where that stands now in July and any improvement pace that's been documented already and how you expect that to play out over the coming months.

Jim Corbett: Well, without thanks, Josh. It's good to hear from you. I'm going to answer this question carefully because there's some things underway and there's some confidential communications going on. Let me answer your question in a few different ways. First of all, there is a multilevel approach to resolve the MACs' speed to adjudicate. On one level, there's been communication between the MACs and central Medicare because some MACs did not have a clear understanding of their responsibility and role. That is largely being taken care of. Second, where you get proof about the adjudication is from the MACs themselves to physicians. That we have seen now in multiple MACs.

Speaker #4: Well, without thanks, Josh. It's good to hear from you. And I'm going to answer this question carefully because there's some things and underway and there's some confidential communications going on.

Speaker #4: But let me say, let me answer your question in a few different ways. First of all, there is a multi-level approach to resolve the MACs speed to adjudicate.

Speaker #4: So on one level, there's been communication between the MACs and central Medicare. Because some MACs did not have a clear understanding of their responsibility and role.

Speaker #4: So that is largely being taken care of. Second, where you get proof about the adjudication is from the MACs themselves to physicians. So that we have seen now in multiple MACs.

Jim Corbett: The 3rd thing you can also see is that among the claims data, which we do not have full access to, there's a perfectly adjudicated case, there's a non-adjudicated case, and a poorly paid adjudicated case, right? There's 3 categories of resolution underway. Where we are now, we've had a very large change in the activity related to the MACs since about 1 June. During June and July, we've seen a steady increase in their interactions, the stakeholders' interactions with the MACs, the processing of claims. It's happening. This is a Category I code, not a Category III code. We have never I don't think we could document a claim that was turned down or failed to be paid before 1 January when Medicare was reimbursing for the Medicaid and Medicare patients where RECELL was used.

Speaker #4: The third thing you can also see is that among the claims data which we do not have full access to, there is a perfectly adjudicated case; there's a non-adjudicated case; and a poorly paid adjudicated case.

Speaker #4: Right? Meaning there's like three categories of, you know, kind of resolution underway. So where we are now, we've had a very large change in the activity related to the MACs since about June 1st.

Speaker #4: And during June and July, we've en a steady increase in their interactions. The stakeholders' interactions with the MACs; the processing of claims. So it's happening.

Speaker #4: You know, this is a category one code, not a category three code. And there's we have never I don't think we could document a claim that was turned down or failed to be paid before January 1st when Medicare was reimbursing for the Medicaid and Medicare patients where resell was used.

Jim Corbett: This came as a rather surprise because they rather easily could have just followed the payment practices that were in existence, although they were attached to other codes. Anyway, does that help? Am I getting to the answer for you?

Speaker #4: So this came as a rather surprise because a rather easily could have just followed the payment practices that were in existence although they were attached to other codes.

Speaker #4: So anyway, does that help? I might get to the answer for you.

Joshua Jennings: Yeah, that does help. Just with this recovery that you've described and the breakthrough in Q3 with multiple MACs adjudicating payments, and you highlighted that the value that multiple MACs are signing RECELL plus split-thickness skin grafts being higher than split-thickness skin grafts alone. Can you talk about the premium that's involved there and how strong of a signal that is for you that helped you kind of forecast this recovery in the coming weeks, months?

Speaker #2: Yeah. That does help. And I'm

Speaker #6: just with this recovery that you've described, and the breakthrough in Q3 with multiple MACs, adjudicating payments, and it sounds and you highlighted that the value that these multiple MACs are signing resell plus split thickness skin grafts being higher than split thickness skin grafts alone.

Speaker #6: Can you talk about the premium that's involved there and how strong of a signal that is for you that helped you get a forecast, this recovery in the coming weeks, months?

Jim Corbett: Well, you see, the analysis that's being used in the crosswalk, depending on the size of the wound, the RVUs basically continue to separate, if you can visualize this, left end of the graph, right end of the graph I mean, the graph, not the graph, but the graph, comparing the two, where you have RVUs on a vertical axis and you have percent TBSA across the horizontal. As you go from 1,000 to 4,000 square centimeters, there's a steady divergence in favor of RECELL utilization and payment versus split-thickness skin graft only to the point where it's 40% more by the time you get to 40%, 4,000 square centimeters. It's kind of hard to visualize. I hope I could visualize that for you. There is a notable premium.

Speaker #4: Well, you see, the analysis that's being used in the crosswalk depending on the size of the wound. The RVUs basically continue to separate if you can visualize this left end of the graph, right end of the graph.

Speaker #4: I mean, the graph, not the graph, but the graph comparing the two. Where you have RVUs on a vertical axis and ou have percent TBSA across the horizontal.

Speaker #4: As you go from 1,000 to 4,000 square centimeters, by the there's a steady divergence in favor of resell utilization and payment versus split thickness skin graft only.

Speaker #4: To the point where it's 40% more by the time you get to 40% 4,000 square centimeters. It's kind of hard to visualize. I hope I could visualize that for you.

Speaker #4: But.

Speaker #6: Got it.

Speaker #4: But there is a notable premium

Joshua Jennings: Thank you for that. Then maybe just lastly, start to tack on a list here of questions. I just noticed the update on Cohealyx and some launch metrics, particularly just the interactions with VACs, 25% of the 130 US burn centers. Did you share or can you share the number of VAC approvals so far? Can we, in what percentage I mean, it's impossible to predict, but how would you have us think about the percentage of the 130 US burn centers where you get through VAC approval and Cohealyx is, I guess, on the formulary, if you will, and you guys are rocking and rolling? Thanks for taking all the questions.

Speaker #6: Thank you for that. And then we just lastly started to tack on a list here of questions. But just notice the update on Cohelix and some launch metrics.

Speaker #6: Particularly just the interactions with VACs 25% of the 130 US burn centers. Did you share or can you share the number of VAC approvals so far?

Speaker #6: And can we in what percentage? I mean, it's impossible to predict. But how would you have us think about the percentage of the 130 US burn centers that have where you get through VAC approval and Cohelix is, I guess, on the formulary, if you will, and you guys are rocking and rolling.

Speaker #6: Thanks for taking all the estions.

Jim Corbett: Thanks, Josh. We're going to keep the number of VAC approvals at a very high level. One reason is our experience with VAC approvals of other products is they're not all equal. What happens when we start disclosing them, the next logical question, are they all equal? Of course, they're not. It really turns into a little bit of a morass. Let me answer in the following way. First principle, we don't get to choose to submit a VAC to a VAC. It actually has to be sponsored by a physician or a department in the hospital. We can propose to them our value proposition, our clinical data, our preclinical data, case studies. They choose to be interested or not.

Speaker #4: Thanks, Josh. We're going to keep the number of VAC approvals at a very high level and one reason is our experience is with VAC approvals of other products is they're not all equal.

Speaker #4: And so what happens when we start disclosing them the next logical question, are they all equal? And of course, they're not. And it really turns in a little bit of a morass.

Speaker #4: So let me answer in the following way. First principle, we don't get to choose to submit a VAC to a VAC. It actually has to be sponsored by a physician.

Speaker #4: And/or a department in the hospital. So we can propose to them our value proposition, our clinical data, our preclinical data, and case studies. They choose to be interested or not.

Jim Corbett: The idea that there's more than 25% of the burn centers that have VAC approvals pending and submitted is a substantial number to happen in the first 60 days of launch of a new product. That's just good news like that. The second is I can say that during April, we trained and were introducing the product. We really started our active selling in May. Having multiple accounts that are ordering here in early July is terrifically quick, by our experience, in terms of timing for getting approvals. Obviously, we have several approved. The third is there's a little bit of time. If the doctors are experiencing 14 to 21 days ready to graft and we're doing it in 7, it still means they don't really know how it's working for 7 days.

Speaker #4: So the idea that there's more than 25% of the burn centers that have VAC approvals pending and submitted is a substantial number to happen in the first 60 days of a launch of a product.

Speaker #4: So that's just good news like that. The second is I can say that during April, we trained and were introducing the product. So we really started our active selling in May.

Speaker #4: Having multiple accounts that are ordering here in early July is a terrifically quick by our experience and in terms of timing from for getting approvals.

Speaker #4: So obviously, we have several. Approved. And the third is the there's a ittle bit of time the doctors are experiencing 14 to 21 days ready to graft and we're doing it in seven.

Speaker #4: It still means they don't really know how it's working for seven days. So they find a patient, they do their first patient, and they have to wait till it's ready to graft.

Jim Corbett: They find a patient, they do their first patient, and they have to wait till it's ready to graft. Typically, they want to see that the graft takes because ready to graft is an assessment, but the graft take is actually the real deal. That's the success of the procedure where you get true closure. An evaluation, really, therefore, if you think about all that, even with our shortened graft time and graft take time, it's still a 3 to 4-week process. I think the hospital that I mentioned in my comments continues to order. They may have ordered 300,000 during their first month of usage. They're on path to do that again in their second month of usage. It is really a great market for this product because it performs better.

Speaker #4: And then typically, want to see that the graft takes because ready to graft is an assessment. But the graft take is actually the real deal.

Speaker #4: That's the success of the procedure. Where you get through closure. So an evaluation really, therefore, if you think about all that, even with our shortened graft time, and graft take time, it's still a three to four week process.

Speaker #4: So I think the hospital, the that I mentioned in my comments, continues to order. They may have ordered 300,000 during their first month of usage.

Speaker #4: They're on path to do that again in their second month of usage. So it is really a great market for this product because it performs better.

Jim Corbett: I really do think it just fits our portfolio great, and it's going to yield great results for us.

Speaker #4: So really, I do think it just fits our portfolio great and it's going to yield great results for us.

Joshua Jennings: Excellent. Thanks a lot, Jim.

Speaker #6: Excellent. Thanks a lot, Jim.

Operator: Thank you. One moment for our next question. Our next question comes from line of Ross Osborn from Cantor Fitzgerald. Your line is open.

Speaker #2: Thank ou. One moment for our next question. Our next question comes from line of Ross Osborne from Cantor Fitzgerald. Your line is open.

Ross Osborn: Hey, guys. Thanks for taking our questions.

Speaker #7: Hey, guys. Thanks for taking our estions. So

Jim Corbett: Hey, Ross.

Ross Osborn: Starting off, and apologies if I missed this, but would you provide an update on how the Mini rollout is going in terms of feedback, adoption, and where you stand in the VAC approval process there?

Speaker #4: Hey, Ross.

Speaker #7: starting off and apologies if I missed this. But would you provide an update on how the mini rollout is going in terms of feedback, adoption, and where you stand and the VAC approval process there?

Jim Corbett: Yeah, I can. It's generally qualitative. The product itself is performing very well. That's A. The physicians who use it tend to be trauma or surgical physicians versus burn. We're finding it to be a product for that level 1 and level 2 trauma center location. The wounds where RECELL is used and burns are actually bigger. The 2,000 sq cm, we actually average more than 1 per case. Where in the level 1 and 2 trauma, you may recall from our PMA, the average patient was 400 sq cm, which is 2.5% TBSA. We're getting good traction. One thing we note, though, is that in trauma and surgery, RECELL is really 1 year old, meaning a lot of physicians had never even heard of spray-on skin of RECELL, where the burns physicians have been at it for 1 year. I mean, for 5 years, rather.

Speaker #4: Yeah. I can. It's generally qualitative. The product itself is performing very well. That's A. The physicians who use it tend to be trauma or surgical physicians versus burn.

Speaker #4: So we're finding it to be a product for that level one and level two trauma center location. The wounds where resell is used and burns are actually bigger.

Speaker #4: They're the 2,000 square centimeters we actually average more than one per case. Where in the level one and two trauma, you may recall from our PMA, the average patient was 400 square centimeters, which is two and a half percent TBSA.

Speaker #4: So we're getting a good traction. One thing we note, though, is that in trauma and surgery, resell is really a year old, meaning a lot of physicians had never even heard of spray-on skin of resell.

Jim Corbett: That's since approval. More than that if you include the PMA time. I think we're getting good traction on the mini. That said, it's a process to get adoption and change the behavior of the physician. They get good results. By the way, this burn data applies to all uses of RECELL. It just happens to be on if you think what a burn is, you excise a big area, it's still a wound, just like a trauma wound's a wound. I think we'll see a lot more from mini because the dermal matrix and PermeaDerm allow us to approach the use of more patients. I think we're looking for a strong H2 from it.

Ross Osborn: Great. Thank you for the color there. Last one on Cohealyx. How should we think about the enrollment period in terms of the duration?

Jim Corbett: Oh, the enrollment of the Cohealyx-I study you're asking, right?

Jim Corbett: Yes. Yeah. Well, first of all, it's a 40-patient protocol, okay? It's done using what's called OPC, Objective Performance Criteria. What we did is we built a protocol around the time to graft and time for graft take and close as the principal outcomes. Since we're proving nearly a 50% to 100% reduction over the OPC, it takes a very small number to statistically prove when you are that much different. We only have to enroll 40 patients. The hard part is over. Our IRBs are open to enrollment at this moment. We have a few still left to go. I think we get enrolled by year-end. That's what we expect. It's 40 patients. Great. Thanks for taking our questions.

Is we built the protocol around the time to graft and time to for graph take and close as the principal outcomes.

and since we're proving,

dearly a

50, to 100% reduction, over the OPC

it takes a very small number to statistically prove when you are that much fat, you know, different

And so we only have to enroll 40 patients.

It's the hard part that is over.

we're almost all our irbs are, um,

Open to enrollment, and it's this moment. We have a few still left to go.

So, I think we get enrolled by year-end; that's what we expect.

Its 40 patients. Thanks for taking our questions.

Operator: Thank you. One moment for our next question. Next question comes from line of Ryan Zimmerman from BTIG. Your line is open.

Thank you. 1 moment for our next question.

Jim Corbett: Hi, Ryan. How are you? Oh, yeah.

Next question, I'm confident of Ryan Zimmerman from btig. Your line is open.

[Analyst] (BTIG): This is actually Izzy on for Ryan. Thanks for taking the questions tonight. Just to start out, given your current cash balance and your burn rate, I was wondering if OrbiMed has waived any of the minimum cash balance requirements. I believe it's about $10 million. If not, how much do you still have available today?

How are you?

Oh, this is actually Izzy on for Ryan. Um, thanks for taking the questions tonight. So just to start out, giving your current cash balance, and your burn rate was wondering if orid has waived any of the minimum cash. Balance balance requirements, I believe it's about 10 million and if not, um, how much do you still have available today?

Jim Corbett: I'm going to have David answer that so we get the right CFO answer here.

David O'Toole: Yeah. Thanks for the question. The OrbiMed has not waived that provision in the amendment. Just to clarify, that provision of $10 million is measured at the end of a quarter, not during the quarter. We don't expect to go below $10 million at any time. We didn't ask them to waive that amendment during the current process.

I'm gonna have David instead, so we get the, uh, right CFO answer here.

Yeah. So um thanks for the question. Uh, the orbit has not waived that uh, provision in the amendment and just to clarify that provision of 10 million dollars is measured at the end of a quarter.

Not during the quarter.

Um, we don't expect to go below 10 million at any time.

Um and so we don't we didn't ask them to waive that Amendment uh during the current process.

[Analyst] (BTIG): Understood. Thank you. With the restructuring to the salesforce you guys completed or began in Q1, I was curious what other expense levers you have contemplated that will help manage your cash burn.

David O'Toole: During the Q2, as Jim mentioned, and so did I, we did a commercial transformation of our salesforce, and we took a look at our entire organization, and we took out $2.5 million per quarter. We see that continuing. It's $10 million annually. We are going to let that play out. We do not see any other levers at this point that need to be pulled.

Understood, thank you. And with the um, restructuring to the sales force, you guys completed or began in first quarter, I was curious what other expense lovers. You have contemplated that will help manage your cash burn.

2 and a half million dollars, uh, per quarter. And we see that, uh, continuing so it's ten million dollars, annually.

[Analyst] (BTIG): Okay, helpful. Last one for me. I was just curious if the 2023 ATM is still in place, and if so, how many shares are available in this, and if there are any restrictions on how many shares you can sell. Thanks for taking the questions.

Um we're going to let that play out. Uh, we don't see any other levers at this point that need to be pulled.

David O'Toole: Yeah. The ATM is still in place. It has, and this is public information, it has about 3.8 million worth of shares that can be sold under the ATM.

Okay, helpful. And then, last one for me, I was just curious if the 2023 ATM is still in place and if so, how many shares are available in this? And if there are any restrictions on how many shares you can sell? Thanks for taking the question.

Yeah, the ATM is still in place.

[Analyst] (BTIG): Thank you for taking the questions.

Um, and it, uh, has. And this is public information. It has about $3.8 million worth of shares that can be sold under the ATM.

Operator: Thank you. This concludes the question-and-answer session. I would now like to turn it back over to Jim, our CEO, for closing remarks.

Thank you for taking the questions.

Thank you. This includes the question and answer session, uh, when I like to turn it back over to Jim our CEO for closing remarks.

Jim Corbett: Well, thank you very much for the questions, and thank you for the time with us today. We have a lot of exciting activities that we're doing that are going to lead to really a great H2. We're really looking forward to that and updating you in the coming quarter on how that goes. Thank you.

Operator: Thank you for your participation in today's conference. This does include the program. You may now disconnect. Everyone, have a great day.

Well, thank you very much for the questions, and thank you for the time with us today. Uh, we have a a lot of exciting activities that we're doing that are going to lead to a really a great second half. So we're really looking forward to to that and updating you in in the coming quarter on how that goes.

Thank you.

Thank you for your participation. In today's conference, this doesn't include the program, you may now disconnect everyone have a great day.