AVITA Medical Inc (RCEL) 2025 Q2 法說會逐字稿

Good day, and thank you for standing by. Welcome to the AVITA Medical second-quarter 2025 earnings conference call. (Operator Instructions) Please be advised that today's call is being recorded.

您好，感謝您的支持。歡迎參加 AVITA Medical 2025 年第二季財報電話會議。（操作員指示）請注意，今天的通話正在錄音。

I would now like to hand it over to your first speaker today, Ben Atkins, Vice President, Investor Relations. Please go ahead.

現在我想把發言權交給今天的第一位發言者，投資者關係副總裁 Ben Atkins。請繼續。

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. 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.

謝謝您，接線生。歡迎參加 AVITA Medical 2025 年第二季財報電話會議。在我們開始之前，我想介紹一下自己。我叫 Ben Atkins，今年 7 月加入 AVITA，負責投資人關係與企業傳播工作。憑藉著多年在生命科學領域的工作經驗，我很高興成為 AVITA 和這個團隊的一員，並期待與我們的投資者社群合作。

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.

參加今天電話會議的還有執行長 Jim Corbett 和財務長 David O'Toole。今天的收益報告和簡報可在我們的網站 www.avitamedical.com 的「投資者關係」部分找到。

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. Please review our most recent filings with the SEC for comprehensive descriptions of the risk factors.

在我們開始之前，我想提醒您，本次電話會議包含 1995 年《私人證券訴訟改革法案》所定義的前瞻性陳述。這些聲明既不是承諾也不是保證，涉及已知和未知的風險和不確定性，可能導致實際結果與前瞻性聲明表達或暗示的任何預期有重大差異。請查看我們最近向美國證券交易委員會提交的文件，以了解風險因素的全面描述。

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.

本次電話會議中提供的任何前瞻性陳述均基於管理層截至今天的預期。我現在將電話轉給吉姆，請他發表評論。

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 quarter. starting with the five key developments shown on slide 4. First, commercial revenue for the second quarter was $18.4 million, up 21% year over year.

在美國與我們一起的各位下午好，澳洲的同事和投資者早安。今天我們有很多內容要講。首先，我想介紹一下本季的情況。首先介紹投影片 4 中顯示的五個關鍵發展。首先，第二季商業收入為1,840萬美元，較去年同期成長21%。

However, sequential revenue was flat and impacted by a temporary headwind that 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 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.

然而，連續收入持平，並受到自三月以來變得更加明顯的暫時逆風的影響。在本季度，我們對醫療保險和醫療補助服務中心以及醫療保險管理承包商如何實施向新的 CPT 1 代碼轉換以使用 RECELL 的重大延遲有了更深入的了解，該代碼於 1 月份生效。這種延遲反過來又影響了供應商的報銷，並最終影響了需求。需要明確的是，這不是產品問題，而是索賠處理問題，這涉及如何評估利用 RECELL 的程序以及如何確定付款。我稍後會更詳細地解釋這一點。

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 second half rebound as resolution of these payment issues is already underway. More on that in a moment. 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.

第三，由於報銷中斷及其對收入的影響，我們下調了 2025 年的財務預測。儘管如此，我們仍然對下半年的反彈充滿信心，因為這些支付問題的解決方案已經在進行中。稍後將對此進行詳細介紹。第四，我們與 OrbiMed 合作，爭取豁免我們第二季度過去 12 個月的收入契約，並修改未來四個季度的契約，讓我們在執行更新後的成長前景時擁有靈活性。最後，我們分享了我們認為 AVITA 史上最重要的臨床證據。

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.

6 月在英國燒傷協會年會上發布的美國國家燒傷登記處的真實世界分析包括超過 6,300 名患者，結果顯示對於燒傷面積不足 30% 的深二度燒傷患者，RECELL 可將住院時間縮短 36%。這證實了臨床醫生告訴我們的事。RECELL 不僅能治癒疾病，還能加速康復，進而重塑醫療經濟。自從數據公佈以來，我們已經看到了人們的興趣和關注。

So let's dig into the headwind I mentioned regarding claims. Turning to slide 5. In November last year, the Centers for Medicare and Medicaid Services, or CMS, announced new Category 1 CPT codes for the use of RECELL in 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.

那麼讓我們深入探討一下我提到的有關索賠的不利因素。翻到幻燈片 5。去年 11 月，美國醫療保險和醫療補助服務中心 (CMS) 在 2025 年規則更新中宣布了使用 RECELL 的新第 1 類 CPT 代碼。值得注意的是，CMS 並沒有像往常一樣直接設定支付率。相反，它透過稱為承包商定價的流程將這項任務分配給醫療保險管理承包商（MAC）。

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. A denied claim or a short claim payment then leads to an appeal and a subsequent adjudication of the code's value.

當 CMS 想要對程式碼進行長期更改時，偶爾會發生這種情況。修改程式碼的工作正在進行中，將持續到 2027 年 1 月。在這兩年的過渡期內，他們可以（而且在這種情況下他們確實這樣做了）將定價責任分配給了承包商。當根據新的 CPT 代碼提交第一批使用 RECELL 的索賠時，MAC 應該裁定代碼並進行付款或拒絕索賠。索賠被拒絕或索賠金額不足將導致上訴，並隨後對代碼的價值進行裁決。

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.

然而，這種情況並非一直發生。隨後，雙方進行了大量有益的互動，但沒有就承包商定價達成結論。從一月到六月，索賠案件不斷增加。為了清楚起見，我們得到了報酬，但我們的供應商沒有得到報酬。這不可避免地導致了這樣的情況：供應商不確定使用 RECELL 後他們將獲得什麼報酬或何時獲得報酬。

So 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. As an example, looking at our top 10 hospitals and their utilization of RECELL 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.

因此，儘管使用 RECELL 的熱情隨著臨床和經濟數據的公佈而增長，但對提供者付款的不確定性抑制了利用率。想像一個調光開關。感覺就是這樣。燈光並沒有熄滅，但隨著索賠不斷增加且沒有明確的裁決，燈光每個月都變得越來越暗。舉例來說，透過比較我們前 10 名的醫院在 2024 年下半年至 2025 年上半年對 RECELL 的使用情況，我們發現光是這 10 個帳戶的收入就減少了約 500 萬美元。

We have determined that in retrospect, this issue has reduced demand for RECELL 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. Those efforts are paying off.

我們已經確定，回想起來，這個問題導致今年上半年對 RECELL 的整體需求減少了約 20%。美國醫學協會和業界的成員已跨多個司法管轄區作出努力來解決此事。這些努力正在發揮成效。

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. We expect demand for RECELL 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 expected recovery in the second half. In turn, we've also agreed with OrbiMed to amend our credit facility.

最近幾週，多家醫療保險承包商已表示有意裁決付款。我們期望所有其他人也能效仿，並相信這個問題將在第三季得到解決。我們預計本季和第四季對 RECELL 的需求將再次回升。因此，我們調整了預期，以反映上半年的實際情況和下半年的預期復甦。反過來，我們也同意與 OrbiMed 修改我們的信貸安排。

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, demonstrating their long-term commitment and confidence in our business. David will review this in the complete financial details shortly. Clearly, we've had a very dynamic first half of the year that has disrupted our business. That said, the enthusiasm from hospital surgeons and patients for our products is stronger than ever.

更新後的條款包括降低截至 2026 年第二季的 12 個月收入契約。作為此次修訂的一部分，OrbiMed 的費用以股權而非現金支付，這表明了他們對我們業務的長期承諾和信心。David 很快就會在完整的財務細節中對此進行審查。顯然，今年上半年我們的業務非常動盪，這擾亂了我們的業務。話雖如此，醫院外科醫生和患者對我們產品的熱情比以往任何時候都更強烈。

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. One broad integrated portfolio targeted at the same wound, the same patient, the same doctor in 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, five 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.

五月份，在我們的急性傷口護理展示會上，我們展示了以患者為中心的治療性急性傷口護理願景，並提供了三種互補的產品和數據來支持它們。一個廣泛的綜合產品組合針對同一傷口、同一患者、同一家醫院的同一位醫生。翻到幻燈片 6。這是一個值得強調的里程碑。6 月份，英國燒傷協會會議期間展示了迄今為止最大規模的 RECELL 真實世界分析，即美國國家燒傷登記處五年的數據。結果顯示燒傷患者的住院時間減少了36％。這不僅具有統計意義，而且具有臨床變革意義。這證實了我們先前的研究以及臨床醫生一次又一次看到的結果。RECELL 幫助患者更快回家。

Typically, these patients must stay in the hospital for a range of weeks. So reducing that time by over 1/3 has real impact. 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.

通常，這些患者必須住院數週。因此，將時間減少 1/3 以上會產生真正的影響。這有什麼關係？因為每個病人在醫院多住一天的費用就會超過 11,000 美元。如果將這個數字乘以 36% 的天數，那麼提早出院的價值就變得不可否認了。

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.

隨著住院時間的縮短，醫院還可以騰出床位並更有效地治療更多病患。我們所強調的影響不僅關乎醫院的底線。早點回家也有利於患者的康復和生活品質。請容許我花點時間與大家分享一個在我們這個行業之外引起共鳴的故事。

Slide 7. Abby Alexander was 18 years old when a fuel explosion in Cambodia left her with life-threatening burners over one-third of her body. She was flown to the US where her face and arm were treated with RECELL. Today, nearly six years later, Abby is thriving.

幻燈片 7。艾比亞歷山大 (Abby Alexander) 18 歲時，柬埔寨發生燃料爆炸，導致她身體三分之一以上的面積燒傷，危及生命。她被空運到美國，在那裡她的臉部和手臂接受了 RECELL 治療。如今，將近六年過去了，艾比茁壯成長。

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. Abby'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.

她最近的前後對比照片在 Reddit 上瘋傳，並被《新聞周刊》和英國國家媒體報導。改變是顯而易見的，臉上的疤痕很少，但她傳達的訊息很清晰。我希望到處都有 RECELL。艾比的故事有力地提醒我們什麼是可能的。這就是為什麼醫院不僅將 RECELL 作為產品採用，而且將其部署為協議，以實現更快的恢復和更有效的護理。

Then turning to slide 9. We have Cohealyx, our collagen-based dermal matrix. Cohealyx just made its peer-reviewed publication debut in the Journal of Surgery. The data demonstrated graft readiness in as little as 5 to 10 days. It typically takes 14 to 28 days with competitor products.

然後翻到第 9 張投影片。我們有 Cohealyx，一種基於膠原蛋白的真皮基質。Cohealyx 剛在《外科雜誌》上首次進行同儕審查發表。數據顯示，移植只需 5 至 10 天即可完成。而競爭對手的產品通常需要 14 到 28 天。

This is 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. 10 days post Cohealyx application, the wound was skin grafted. The majority of the wound was re epithelialized within two 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.

本案例研究說明了這一點，一名患有多種合併症的 48 歲男性，右手出現全層傷口，覆蓋全身表面積的 11.25%，是一個相當大的開放性傷口。使用 Cohealyx 10 天后，對傷口進行了皮膚移植。皮膚移植後兩週內，大部分傷口重新上皮化。根據臨床醫師的評估，患者的功能恢復情況良好。縮短移植時間對於複雜傷口的治療來說是一個突破，同時也縮短了住院時間。

Building on our preclinical and clinical research, our post-market clinical study, Cohealyx-1, 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 we'll keep you updated as the data builds.

在我們的臨床前和臨床研究的基礎上，我們的上市後臨床研究 Cohealyx-1 將評估其在現實環境中的表現。該研究將檢視創傷和燒傷治療的移植時間、臨床療效和成本節約。研究站點正在招募，我們將隨著數據的累積及時向您更新。

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.

翻到第 10 張投影片。我想介紹產品組合中的一些亮點，我們認為這些亮點為我們改變急性傷口護理的願景提供了動力。自 6 月在英國燒傷協會展示 RECELL 數據以來，兩家大型醫院、一家學術醫療中心和一個地區燒傷中心正在採用更廣泛的 RECELL 資格協議，以涵蓋所有體表面積低於 20% 的燒傷。

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.

這些數據導致 RECELL 的轉變，RECELL 的供應成本作為導致住院時間延長的協議治療。透過這種方法，我們對新策略進行了市場測試。該戰略是一項基於成果的合作協議。在本協議中，使用 RECELL 的目標是減少住院時間。

And if it does not achieve that result, the hospital receives a rebate. We've reached agreement with two centers since June. This type of arrangement is driven by our belief in our RECELL data. It's built on a very large database of patients, so it's highly reliable. We trust it.

如果沒有達到這個結果，醫院就會收到退款。自六月以來，我們已經與兩個中心達成協議。這種安排是由我們對 RECELL 數據的信心所驅動的。它建立在一個非常龐大的患者資料庫之上，因此非常可靠。我們相信它。

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.

我們預計，光是這兩個中心每個月的 RECELL 單位就會增加約 150 名患者。值得注意的是，即使我們必須支付回扣（我們認為這不是必要的），但隨著這些額外患者的治療，我們的收入基礎也大幅增加。我們認為這種商業模式在全國其他設施中具有很高的適應性。在美國，幾乎所有燒傷中心都使用 RECELL。如您所知，去年我們一直在擴展到 1 級和 2 級創傷中心。

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.

本週，我們獲得了美國醫療保險監管機構 CMS 的批准，為 RECELL 用於創傷傷口和住院患者提供名為 NTAP（新技術附加支付）的特殊報銷。

What does that mean? It means hospitals can now receive additional payment from Medicare when RECELL is used in these cases above and additive to the standard reimbursement. It's designed to accelerate access to breakthrough devices like ours by offsetting hospitals' cost of adopting the technology.

這意味著什麼？這意味著當在上述情況下使用 RECELL 時，醫院現在可以從 Medicare 獲得額外付款，並將其添加到標準報銷中。其目的是透過抵消醫院採用該技術的成本來加速獲得像我們這樣的突破性設備。

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 October 1 and will be in place for one year. We believe this will drive increased utilization in the inpatient setting and support further expansion into trauma and surgical wounds. While the NTAP supports RECELL in the inpatient setting, we're also expanding access in the outpatient care.

這是來自 CMS 的強烈訊號。它承認了 RECELL 的臨床價值並有助於消除採用該療法的財務障礙。該政策於10月1日生效，有效期一年。我們相信這將推動住院環境利用率的提高，並支持進一步擴展到創傷和手術傷口。雖然 NTAP 在住院環境中支持 RECELL，但我們也在擴大門診護理的覆蓋範圍。

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.

這就是 RECELL GO mini 的作用所在。在我們的上市前批准研究中，我們發現平均創傷面積約為 400 平方公分。這項見解直接影響了 RECELL GO mini 的設計，與可治療 1,920 平方公分傷口的標準 RECELL 相比，該設計針對 480 平方公分或更小的傷口進行了優化。

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.

現在，創傷外科醫生可以在門診環境中使用適當大小的 RECELL 噴霧更有效地治療較小的傷口。它針對 RECELL 在創傷護理中的實際應用進行了精確設計，並為醫院外更廣泛的應用打開了大門。

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. 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.

我們的國際業務的簡要更新。我們預計 CE 標誌將在第三季獲得批准。但由於我們指定機構的官僚主義持續拖延，批准可能會推遲到第四季。雖然這推遲了我們在歐盟和澳洲的上市，但我們準備在獲得批准後繼續採用經濟精益的分銷商主導的商業模式。Cohealyx 自 4 月推出以來取得了良好的開局。

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.

需要提醒的是，Cohealyx 具有成本競爭力，利潤率高，且移植準備時間短。美國全國有 120 至 130 個燒傷中心，其中約 25% 的燒傷中心尚待價值分析委員會提交報告。隨著醫院獲得 VAC 批准，我們看到商業勢頭迅速增長。7月份，我們建立了多個訂購帳戶。

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. 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.

事實上，光是 7 月份，我們最大的客戶就訂購了近 30 萬美元的 Cohealyx。我們對與 Cohealyx 合作的機會感到非常興奮。考慮一下，我們每月銷售超過 1,000 套 RECELL 套件。如果這 1,000 個病人中，只有 10%（每位病人平均覆蓋 2,000 平方公分）以市場價格使用我們的 Cohealyx 真皮基質，那麼每年就能額外產生 3,600 萬美元的收入。重申一下，這為我們的市場帶來了無與倫比的機會。

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. Then as we expand from burn to include also trauma, we have PermeaDerm, our biosynthetic dressing. We in-source 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.

我們有 RECELL，可以將住院時間縮短 36%。此外，Cohealyx 能夠比我們的競爭對手提前 7 到 14 天完成嫁接。然後，當我們從燒傷擴展到創傷時，我們有了 PermeaDerm，我們的生物合成敷料。我們將 PermeaDerm 的生產外包到我們最先進的文圖拉工廠。提醒一下，PermeaDerm 可作為臨時生物合成敷料，在移植前、移植癒合期間以及移植癒合後護理期間暫時緩解傷口並控制水分。

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 after care. Our PermeaDerm-1 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 and the versatility of PermeaDerm, its potential to replace allograft and its integration into our portfolio is reflected in a standout quarter in sales.

本季度，它在美國燒傷會議上進行了 10 場演講，展示了其在各種傷口類型和治療階段直至癒合中的應用。其中包括一項隨機試驗，結果顯示單次使用後護理更加容易。我們目前正在積極招募的 PermeaDerm-1 研究正在比較 PermeaDerm 和用於需要皮膚移植來治癒傷口的患者中的同種異體移植的成本和臨床結果。我們對 PermeaDerm 的多功能性、其替代同種異體移植的潛力以及其與我們產品組合的整合感到興奮，這反映在本季度的銷售表現突出。

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. 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.

隨著對我們的急性傷口護理產品組合的興趣日益增長，我們正在透過策略集團採購組織合約、GPO 和多個綜合交付網路 (IDN) 擴大我們產品的獲取管道。這些協議將我們與這些系統內的燒傷中心和 1 級和 2 級創傷中心聯繫起來，允許這些機構的醫生使用 RECELL、Cohealyx 和 PermeaDerm。

I'd like to provide an update on the transformation of our US sales organization. To remind you, on April 1, 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.

我想提供有關我們美國銷售組織轉型的最新情況。提醒您，4 月 1 日，我們重新設計了我們的商業組織，考慮到我們的代表需要參與兩階段程序的兩個階段，以優化兩個階段中使用的 RECELL、Cohealyx 和 PermeaDerm 的銷售。

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.

這與我們先前的策略相比發生了重大變化，先前的策略依賴於不承擔銷售職責的臨床專家提供的大量臨床支援。在實施過程中，我們從以服務為導向轉向以銷售為導向。

Consequently, we developed a more focused and efficient selling organization, taking our field headcount from 108 to 82 people, and consequently, save 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 period.

因此，我們建立了一個更專注、高效的銷售組織，將現場員工人數從 108 人減少到 82 人，每季節省近 250 萬美元。這 250 萬美元中的大部分來自此次重組，並導致我們的年度現金需求減少 1000 萬美元，我們在第二季度有效地實現了這一目標。

So 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.

最後翻到幻燈片 7。這一切意味著什麼？創新與整合，全面的傷口閉合解決方案，旨在改善患者預後並快速優化癒合。RECELL、Cohealyx、PermeaDerm 像管弦樂團一樣同步運作。每種產品都會加速護理。

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.

它們共同加速價值的創造。減少住院時間，就可降低醫療費用。當縮短復原時間時，患者就能更快回家與家人團聚。當病人早點回家時，你就可以釋放出更多的容量。這就是 AVITA 平台所提供的，也是為什麼這個機會與市場上的其他機會不同。

We are a multiproduct platform with eyes on a $3.5 billion opportunity. Same wound, same patient, same doctor, same hospital, but 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.

我們是一個多產品平台，著眼於 35 億美元的商機。同樣的傷口、同樣的病人、同樣的醫生、同樣的醫院，但現在癒合速度更快、療效更好、費用更低。我們已經重置並做好準備。同時，我們正在加強領導力，以適應下一章。正如您在昨天的新聞稿中看到的，我很高興歡迎博士。

Michael Tarnoff to our Board. Michael was the Chief Physician Executive and CEO at Tufts 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.

Michael Tarnoff 加入我們的董事會。麥可曾擔任波士頓塔夫茨大學的首席醫師執行長兼首席執行官，並在 Medtronic 和 Covidien 擔任高級領導職務。他的臨床專業知識和在外科手術創新方面的領導能力將在我們擴大規模的過程中發揮重要作用。

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 helps shape the foundation we're now building on.

我要感謝 Lou Panaccio，他擔任我們的董事會主席，見證了 AVITA 從早期的商業里程碑到今天的發展。盧的穩健指導幫助我們奠定了現在的基礎。

And I want to thank him for that effort. 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 med tech innovation help us accelerate into our next phase of growth.

我要感謝他的努力。我很高興歡迎卡里·萬斯 (Cary Vance) 接任主席職位。Cary 豐富的商業和營運經驗以及對醫療技術創新的熱情幫助我們加速進入下一階段的成長。

Now I'll pass it over to David to review our financials.

現在我將交給大衛來審查我們的財務狀況。

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. This growth was mainly driven by the broadening deployment of our RECELL system, particularly RECELL GO and in spite of the headwinds during the first half of 2025 that Tim spoke about.

謝謝你，吉姆。截至 2025 年 6 月 30 日的三個月，我們的商業收入為 1,840 萬美元，與 2024 年同期相比成長 21%。這一增長主要得益於我們 RECELL 系統（尤其是 RECELL GO）的廣泛部署，儘管 Tim 談到了 2025 年上半年的逆風。

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 the second quarter was 81.2%, down from 86.1% during the same period in 2024.

其他貢獻來自於我們的新產品 Cohealyx 和 PermeaDerm，以及從燒傷中心擴展到針對創傷中心的新帳戶。第二季毛利率為81.2%，低於2024年同期的86.1%。

Note that the gross margin for RECELL products alone was 84.3% for the quarter, 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. Regarding gross margin and gross profit, we expected our gross margin percentage to decline as revenue from PermeaDerm and Cohealyx grew.

請注意，本季僅 RECELL 產品的毛利率就達到 84.3%，我們相信未來幾季的毛利率將維持在這個範圍內。整體毛利率較上年下降，主要由於產品結構調整、庫存儲備增加等調整。關於毛利率和毛利，我們預計隨著 PermeaDerm 和 Cohealyx 收入的成長，我們的毛利率百分比將會下降。

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.

正如我們之前所揭露的，我們分享 Cohealyx 50% 的平均銷售價格，分享 PermeaDerm 60% 的平均銷售價格。這些分銷安排將貢獻可觀的毛利和營運現金流，但會影響整體毛利率。

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.

本季總營運費用為 2,610 萬美元，低於 2024 年同期的 2,870 萬美元。這一下降主要是由於銷售和行銷成本減少了 200 萬美元，這得益於工資、福利、佣金和股票薪酬等員工相關費用的降低。

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.

一般及行政費用也下降了 80 萬美元，主要原因是薪資、福利、遞延薪資、專業費用和公司成本減少。研發費用略有增加，為 20 萬美元，主要由於工資和福利增加。如前所述，由於我們最近在第二季實施的商業領域轉型和提高營運效率，我們本季減少了約 240 萬美元的營運費用。

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 noncash expenses of approximately $2.7 million in stock-based compensation and approximately $0.8 million in depreciation and amortization.

我們預計未來每季都能實現相同或更多的節省，相當於每年節省 1000 萬美元。第二季的 2,610 萬美元營運費用包括約 270 萬美元的股票薪酬非現金費用和約 80 萬美元的折舊和攤提非現金費用。

Other income expense increased by $0.9 million to $2.5 million of income for the quarter, consisting of noncash gains totaling $1.2 million related to changes in the fair value of warrants and $0.9 million related to changes in the fair value of the debt, along with $0.4 million in investment income. The second quarter's 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 60% -- $0.60 per basic and diluted share in the same period of 2024. As of June 30, our cash and marketable securities totaled $15.7 million compared to $35.9 million at December 31, 2024.

本季其他收入支出增加了 90 萬美元，達到 250 萬美元，其中包括與認股權證公允價值變動相關的非現金收益總計 120 萬美元、與債務公允價值變動相關的 90 萬美元，以及 40 萬美元的投資收益。第二季淨虧損為 990 萬美元，即每股基本虧損和稀釋虧損均為 0.38 美元，較 2024 年同期的淨虧損 1,540 萬美元或 60%（每股基本虧損和稀釋虧損均為 0.60 美元）改善了 36%。截至 6 月 30 日，我們的現金和有價證券總額為 1,570 萬美元，而 2024 年 12 月 31 日為 3,590 萬美元。

Although the accounts receivable balance of approximately $11.3 million as of June 30 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.

儘管截至 6 月 30 日約 1,130 萬美元的應收帳款餘額將有助於我們滿足第三季預期的營運資金需求，但我們仍打算籌集更多資金以加強我們的資產負債表並支持我們的營運資金需求。

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. Additionally, on August 7, 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 30, 2025.

談到我們的 OrbiMed 信用協議。6 月底，我們獲得了第二季過去 12 個月收入契約的豁免，金額為 7,800 萬美元。此外，8 月 7 日，我們簽署了信貸協議修正案，從截至 2025 年 9 月 30 日的季度開始，將未來四個季度的收入契約調整為 7,300 萬美元、7,700 萬美元、9,000 萬美元和 1.03 億美元。

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, a cash fee, further demonstrating their confidence in our long-term strategy.

作為對此修訂的補償，我們向 OrbiMed 發行了 400,000 股 AVITA 普通股。我們感謝 OrbiMed 的持續支持，他們接受股票而不是現金，即現金費用，這進一步表明了他們對我們長期策略的信心。

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.

談談今年剩餘時間的財務展望。由於 Jim 概述的上半年面臨的阻力，我們將 2025 年全年商業收入預期從先前估計的 1 億至 1.06 億美元修改為 7,600 萬美元至 8,100 萬美元。

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 of 2026 and reach GAAP profitability in Q3 of 2026 compared to our earlier plan of generating free cash flow in the second half of 2025 and achieving GAAP profitability in Q4 of 2025.

新的 2025 年全年營收指引顯示，與 2024 年相比，營收將成長約 19% 至 27%。此外，我們現在預計將在 2026 年第二季度開始產生自由現金流，並在 2026 年第三季度實現 GAAP 盈利，而我們之前的計劃是 2025 年下半年產生自由現金流，2025 年第四季度實現 GAAP 盈利。

Even with the many challenges we have faced in the first half of this year, I want to reiterate our optimism for the future. There is clear evidence of green shoots or signs of growth across our business. These include, we finished the second quarter with June marking one of our strongest revenue months to date as visibility to reimbursement began to emerge.

儘管今年上半年我們面臨諸多挑戰，但我仍想重申我們對未來的樂觀態度。有明顯證據表明我們的業務出現了復甦跡像或成長跡象。其中包括，我們在第二季結束時，6 月成為我們迄今為止收入最高的月份之一，因為報銷情況開始顯現。

Even more encouragingly, revenue in July and early part of August has signaled a strong start to the third quarter. From a revenue standpoint, we view the size and speed of orders we received from our first Value Analysis Committee or VAC approved accounts this July as an early indicator of the potential strong demand for Cohealyx.

更令人鼓舞的是，7月份和8月初的營收預示著第三季的強勁開局。從收入的角度來看，我們認為今年 7 月從我們的第一個價值分析委員會或 VAC 批准帳戶收到的訂單的規模和速度是 Cohealyx 潛在強勁需求的早期指標。

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.

憑藉我們在手術室和燒傷外科醫生中的專有地位，我們展示 Cohealyx 臨床益處的能力與競爭對手相比是無與倫比的。我們只需要獲得批准並轉換一小部分程序就能對我們的收入產生顯著的影響。

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.

先前討論過的基於結果的新商業模式，對於某些機構來說，RECELL 並不是治療全身表面積不足 20% 的燒傷的標準方法，這種模式有可能產生更多的收入。我們已經實施的設施只是這種商業模式的開端。

In closing, we are hyper-focused on executing our operating plan for the remainder of 2025.

最後，我們高度重視執行 2025 年剩餘時間的營運計畫。

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.

因此，在回答您的問題之前，我將把電話轉回給吉姆，讓他談談今年剩餘時間的主要收穫。

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 the second half 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.

謝謝，大衛。在我們開始提問之前，我想先簡單回顧一下最重要的問題。首先，隨著索賠積壓問題的解決，我們預計 RECELL 的需求將在下半年全面恢復。其次，我們修訂後的指引反映了復甦和我們邁向 2026 年的勢頭。第三，我們對 OrbiMed 協議的修訂加強了圍繞這一前進道路的長期協調。

And 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.

最後，真實世界數據顯示，使用 RECELL 後住院時間縮短了 36%，這不僅是臨床見解，更是改善結果和增強醫院經濟效益的價值主張。簡而言之，我們專注、執行並且做好加速的準備。接線員，好了，讓我們開始提問。

(Operator Instructions) Josh Jennings, TD Cowen.

（操作員指示）Josh Jennings，TD Cowen。

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

僅就解決方案和積壓的索賠而言。聽起來它正在進行中——我應該說，是在七月。如果可以的話，請帶我們來了解幾種不同的情境分析。我的意思是，所有 MAC 多快才能加入？

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, 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?

或許您可以讓我們了解一下，今年上半年有多少起索賠，有多少比例的索賠被拒絕，如果有的話，七月份的索賠情況如何，有沒有已經記錄下來的改善速度，以及您預計未來幾個月的情況會如何？

Well, without -- thanks, Josh. It's good to hear from you. And I'm going to answer this question carefully because there are some things underway and there's some confidential communications going on. But let me say -- 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.

好吧，沒有——謝謝，喬希。很高興收到你的來信。我將謹慎地回答這個問題，因為有些事情正在進行中，而且正在進行一些機密溝通。但請容許我以幾種不同的方式來回答你的問題。首先，有許多方法可以解決MAC的裁決速度問題。

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. So that is largely being taken care of. Second, where you get proof about the adjudication is from the MACs themselves to physicians.

因此，從某種程度上來說，MAC 和中央醫療保險之間存在溝通，因為有些 MAC 不清楚自己的責任和角色。因此，這個問題基本上已經解決。其次，關於裁決的證據來源是 MAC 本身向醫生提供的證據。

So that we have seen now in multiple MACs. 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 nonadjudicated case and a poorly paid adjudicated case, right?

我們現在已在多個 MAC 中看到了這一點。第三件事你還可以看到，在我們無法完全訪問的索賠數據中，有一個裁決完美的案件，有一個未經裁決的案件和一個裁決金額很低的案件，對嗎？

Meaning there's like three categories of resolution underway. So where we are now, we've had a very large change in the activity related to the MAC since about June 1. And during June and July, we've seen a steady increase in their interactions, the stakeholders' interactions with the MACs, the processing of claims. So it's happening. This is a Category 1 code, not a Category 3 code.

這意味著有三類解決方案正在進行中。因此，就目前情況而言，自 6 月 1 日左右以來，與 MAC 相關的活動發生了很大變化。在六月和七月期間，我們看到他們的互動、利益相關者與 MAC 的互動以及索賠處理穩步增加。所以它正在發生。這是第 1 類代碼，而不是第 3 類代碼。

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 1 when Medicare was reimbursing for the Medicaid and Medicare patients where RECELL was used.

而且——我們從來沒有——我認為我們無法記錄在 1 月 1 日之前被拒絕或未能支付的索賠，當時 Medicare 正在為使用 RECELL 的 Medicaid 和 Medicare 患者報銷。

So 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. So anyway, does that help? Am I getting to the answer for you?

所以這讓人相當驚訝，因為他們可以輕鬆遵循現有的支付慣例，儘管這些慣例附加在其他代碼上。那麼無論如何，這有幫助嗎？我是否能為您找到答案？

Yeah, that does help. And I'm just -- 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, the 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 help you forecast this recovery in the coming months?

是的，這確實有幫助。我只是 — — 只是根據您所描述的這種復甦和第三季度多個 MAC 裁定付款的突破，聽起來 — — 並且您強調了這些多個 MAC 簽署的價值，中厚皮移植的價值高於單獨的中厚皮移植。您能否談談其中涉及的溢價以及這對您來說是一個多強的信號，以幫助您預測未來幾個月的復甦？

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 our views on the vertical axis and you have percent TBSA across the horizontal.

嗯，您可以看到人行橫道中使用的分析，根據傷口的大小，RVU 基本上會繼續分離，如果您可以想像這一點，圖表的左端，圖表的右端，我的意思是圖表，不是圖表，而是比較兩者的圖表，其中您可以在垂直軸上看到我們的視圖，而在水平軸上有百分比 TBSA。

As you go from 1,000 to 4,000 square centimeters, by -- there's a steady divergence in favor of RECELL utilization and payment versus split the skin graft only to the point where it's 40% more by the time you get to 40% -- 4,000 square centimeters. It's hard to visual -- I hope I can visualize that for you. But there is a notable premium.

當面積從 1,000 平方公分增加到 4,000 平方公分時，RECELL 利用率和付款與分裂皮膚移植的比例逐漸出現分歧，當面積達到 40%（即 4,000 平方公分）時，分歧會增至 40%。這很難想像——我希望我能為你想像出來。但有一個明顯的溢價。

And then maybe just lastly, sort to tack on a list here of questions, but 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?

最後，也許只是對這裡的一系列問題進行排序，但剛剛注意到 Cohealyx 的更新和一些發布指標，特別是與 VAC 的互動，占美國 130 個燒傷中心的 25%。您是否分享過或可以分享迄今為止 VAC 批准的數量？

And can we -- 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 Cohealyx is, I guess, on the formulary, if you will, and you guys are rocking and rolling.

我們可以嗎 - 百分比是多少 - 我的意思是，這無法預測，但是您讓我們如何考慮美國 130 家燒傷中心的百分比 - 您通過 VAC 批准並且 Cohealyx 出現在處方集上，如果您願意的話，你們正在搖滾和滾動。

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. And so what happens when we start disclosing them, the next logical question, are they all equal? And of course, they're not.

謝謝，喬希。我們將保持 VAC 批准數量處於非常高的水平。原因之一是，我們的經驗表明，其他產品的 VAC 批准並不完全相同。那麼，當我們開始揭露它們時會發生什麼，下一個合乎邏輯的問題是，它們都是平等的嗎？當然，事實並非如此。

And it really turns in a little bit of a morass. 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 and/or a department in the hospital. So we can propose to them our value proposition, our clinical data, our preclinical data, case studies, they choose to be interested or not.

它確實變成了一個有點混亂的情況。那麼讓我按照以下方式回答。第一個原則是，我們不能選擇向 VAC 提交 VAC。它實際上必須由醫生和/或醫院的某個部門贊助。因此，我們可以向他們提出我們的價值主張、臨床數據、臨床前數據、案例研究，他們可以選擇是否有興趣。

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 new product. So that's just good news like that.

因此，有超過 25% 的燒傷中心正在等待並提交 VAC 批准，這是一個相當可觀的數字，在新產品推出後的前 60 天內就會出現。這真是個好消息。

The second is I can say that during April we trained and we're introducing the product. So we really started our active selling in May. Having multiple accounts that are ordering here in early July is terrifically quick by our experience and in terms of timing from -- for getting approvals.

第二，我可以說，四月我們進行了培訓，並且正在推出產品。因此，我們從五月就開始積極銷售。根據我們的經驗，七月初有多個帳戶在這裡訂購，從獲得批准的時間來看，速度非常快。

So obviously we have several approved. And the third is the, 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 seven, it still means they don't really know how it's working for seven days.

顯然我們已經批准了其中的幾項。第三，還有一點時間。如果醫生需要 14 到 21 天才能做好移植準備，而我們只花了 7 天，那麼這仍然意味著他們並不真正了解 7 天內移植的效果如何。

So they find a patient, they do their first patient, and they have to wait until it's ready to graft. And then 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.

因此，他們找到一名患者，對第一位患者進行治療，然後必須等到移植準備就緒。然後通常，他們希望看到貪污行為是否成功，因為準備貪污是一項評估，但貪污行為實際上是真實的。

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. So 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.

這就是程式成功結束的標誌。因此，如果您考慮所有這些，即使我們縮短了移植時間和移植需要時間，它仍然是一個需要三到四週的過程。所以我認為我在評論中提到的醫院會繼續訂購。他們可能在使用的第一個月就訂購了 30 萬個。

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. So we do think it just fits our portfolio great, and it's going to yield great results for us.

他們在使用的第二個月就再次這樣做了。因此，由於其性能更佳，這款產品確實有龐大的市場。所以我們確實認為它非常適合我們的投資組合，並且會為我們帶來巨大的收益。

Ross Osborn, Cantor Fitzgerald.

羅斯奧斯本、康托費茲傑拉。

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?

首先，如果我錯過了這一點，請原諒，但您能否提供有關小型推廣的反饋、採用情況以及您在 VAC 審批流程中所處位置的最新情況？

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.

是的，我可以。整體來說，這是定性的。產品本身表現非常好。那是 A。使用它的醫生往往是創傷或外科醫生，而不是燒傷醫生。

So we're finding it to be a product for that Level 1 and Level 2 trauma center location. The wounds where RECELL is used in burns are actually bigger. The 2,000 square centimeters, we actually average more than one per case, where in the level 1 and 2 trauma, you may recall from our PMA, the average patient was 400 square centimeters, which is 2.5% TBSA.

因此，我們發現它是適合 1 級和 2 級創傷中心的產品。使用RECELL治療的燒傷傷口實際上更大。2,000 平方厘米，實際上我們平均每個病例超過一個，在 1 級和 2 級創傷中，您可能還記得我們的 PMA，平均患者為 400 平方厘米，即 2.5% TBSA。

So we're getting good traction. One thing we note though is that in trauma and surgery, RECELL is really a year old, meaning a lot of physicians had never even heard of spray-on skin of RECELL, where the burn physicians have been added for a year, I mean for five years rather.

因此我們獲得了良好的進展。但我們注意到的一件事是，在創傷和外科手術中，RECELL 實際上已經有一年的歷史了，這意味著許多醫生甚至從未聽說過 RECELL 噴霧皮膚，而燒傷醫生已經使用了一年，我的意思是五年了。

And that's since approval. So more than that if you include the PMA time. So I think we're getting good traction on the mini. But that said, it's a process to get adoption and change the behavior of the physician. They get good results.

這是自批准以來。如果包括 PMA 時間的話，那就更多了。所以我認為我們在迷你方面取得了良好的進展。但話雖如此，這是一個獲得採納並改變醫生行為的過程。他們取得了良好的結果。

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 is a wound. So 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. So I think we're looking for a strong second half from it.

順便說一句，此燃燒數據適用於 RECELL 的所有用途。它恰好是 - 如果你想想燒傷是什麼，你切除一大片區域，它仍然是一個傷口，就像外傷傷口是一個傷口一樣。因此我認為我們將從 mini 中看到更多，因為真皮基質和 PermeaDerm 使我們能夠為更多患者提供服務。所以我認為我們期待下半年表現強勁。

Great. And then last one on Cohealyx. How should we think about the enrollment period in terms of the duration?

偉大的。最後一個是關於 Cohealyx 的。從持續時間上來說，我們應該如何考慮入學期限？

The enrollment of the Cohealyx-1 study, you're asking, right?

您問的是 Cohealyx-1 研究的招募情況，對嗎？

Yeah.

是的。

Yeah. Well, first of all, it's a 40-patient protocol, okay? And it's done using what's called OPC, objective performance criteria. So what we did is we built a protocol around the time to graft and time to -- for graft take and close as the principal outcomes. And 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.

是的。嗯，首先，這是一個針對 40 名患者的方案，好嗎？它是使用所謂的 OPC（客觀績效標準）來完成的。因此，我們所做的就是圍繞移植時間和移植完成時間制定一個協議，作為主要結果。而且由於我們證明 OPC 減少了近 50% 到 100%，因此只需一個非常小的數字就可以從統計上證明差異有多大。

And so we only have to enroll 40 patients. The hard part is over, where almost all our IRBs are open to enrollment at this moment. We have a few still left to go. So I think we get enrolled by year-end. That's what we expect. That's 40 patients.

所以我們只需要招募 40 位患者。最困難的部分已經過去了，目前我們幾乎所有的 IRB 都已開放註冊。我們還剩下一些事情要做。所以我認為我們會在年底前入學。這正是我們所期望的。共有 40 名患者。

Ryan Zimmerman, BTIG.

Ryan Zimmerman，BTIG。

This is actually Izzy on for Ryan. Thanks for taking the questions today. So 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 requirement. I believe it's about $10 million. And if not, how much do you still have available today?

這實際上是 Izzy 為 Ryan 表演的。感謝您今天回答這些問題。因此，首先，考慮到您目前的現金餘額和燒錢率，我想知道 OrbiMed 是否免除了任何最低現金餘額要求。我認為大約是 1000 萬美元。如果沒有的話，您今天還有多少可用資金？

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

我會讓大衛回答這個問題，這樣我們就能得到正確的財務長答案。

Yeah. So thanks for the question. The OrbiMed has not waived that provision in the amendment. And 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. And so we don't -- we didn't ask them to waive that amendment during the current process.

是的。感謝您的提問。OrbiMed 並未在修正案中放棄該條款。需要澄清的是，這 1000 萬美元的撥備是在季度末衡量的，而不是在季度內衡量的。我們預計任何時候都不會低於 1000 萬美元。因此，我們不會——我們沒有要求他們在當前過程中放棄該修正案。

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

明白了。而隨著你們在第一季完成或開始的銷售團隊重組，我很好奇你們還考慮了哪些其他費用槓桿來幫助管理現金消耗？

So during the second quarter, as Jim mentioned, and so did I, we did a commercial transformation of our sales force, and we took a look at our entire organization, and we took out $2.5 million per quarter. And we see that continuing. So it's $10 million annually. We are going to let that play out. We don't see any other levers at this point that need to be pulled.

因此，正如吉姆和我所提到的，在第二季度，我們對銷售團隊進行了商業轉型，並審視了整個組織，我們每季支出 250 萬美元。我們看到這種情況還在繼續。所以每年是1000萬美元。我們將讓這一幕發生。目前我們還沒有看到需要採取任何其他措施。

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 questions.

好的。很有幫助。這是我的最後一個。我只是好奇 2023 年的 ATM 是否還在使用？如果有的話，其中有多少股可用？您可以出售的股票數量有什麼限制嗎？感謝您回答這些問題。

Yeah. The ATM is still in place, and it has -- and this is public information, it has about 3.8 million worth of shares that can be sold under the ATM.

是的。ATM 仍在運行，而且 — — 這是公開訊息，它有價值約 380 萬股股票可以在 ATM 下出售。

Thank you for taking the questions.

感謝您回答這些問題。

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.

謝謝。問答環節到此結束。現在我想把發言權交還給我們的執行長吉姆，請他做最後發言。

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 second half. So we're really looking forward to that and updating you in the coming quarter on how that goes. Thank you.

好吧，非常感謝您提出的問題，也感謝您今天抽出時間接受我們的訪問。我們正在進行許多令人興奮的活動，這些活動將帶來真正精彩的下半年。因此，我們非常期待這一點，並在下個季度向您通報進度。謝謝。

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

感謝大家參加今天的會議。該計劃確實就此結束。您現在可以斷開連線。祝大家有個愉快的一天。