AVITA Medical Inc (RCEL) 2025 Q1 法說會逐字稿

Good day, and thank you for standing by. Welcome to AVITA Medical First Quarter 2025 Earnings Conference Call. (Operator Instructions) Please note that today's conference is being recorded. I will now hand the conference over to your first speaker for today, Jessica Ekeberg. Please go ahead.

您好，感謝您的支持。歡迎參加 AVITA Medical 2025 年第一季財報電話會議。（操作員指示）請注意，今天的會議正在錄音。現在我將會議交給今天的第一位發言者傑西卡·埃克伯格 (Jessica Ekeberg)。請繼續。

Thank you, operator. Welcome to AVITA Medical's First Quarter 2025 Earnings Call. Joining me on today's call are Jim Corbett, Chief Executive Officer; and David O'Toole, Chief Financial Officer. Today's earnings release and presentation are available on our website, www.avitamedical.com under the Investor Relations section. Before we begin, I'd like to remind you that this call includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.

謝謝您，接線生。歡迎參加 AVITA Medical 2025 年第一季財報電話會議。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。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。

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 a 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.

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，以獲取有關風險因素的全面描述。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。

Thank you, Jessica. Good afternoon to those joining us here in the U.S., and good morning to our colleagues and investors in Australia. We entered 2025 stronger, sharper and more strategically prepared than ever before. There's more to do, but the foundation we've built gives us the opportunity to accelerate and deliver against the full potential of our expanded platform. Let's turn to Slide 3.

謝謝你，潔西卡。向我們在美國參加會議的各位下午好，向我們在澳洲的同事和投資者們早安。我們將以比以往更強大、更敏銳、策略準備更加充分的姿態邁入2025年。還有很多工作要做，但我們已經建立的基礎使我們有機會加速並充分發揮我們擴展平台的潛力。讓我們翻到幻燈片 3。

We are no longer a single product burn-only company. Today, we are a fully integrated multiproduct platform positioned to lead in therapeutic acute wound care. With this transformation, our U.S. addressable market has expanded from roughly $500 million to more than $3.5 billion annually. That's a sevenfold increase that materially reshapes our long-term growth trajectory.

我們不再是一家只生產單一產品的公司。如今，我們已成為一個完全整合的多產品平台，致力於引領治療性急性傷口護理。透過這項轉型，我們在美國的潛在市場規模已從每年約 5 億美元擴大到 35 億美元以上。這是一個七倍的成長，從根本上重塑了我們的長期成長軌跡。

Revenue for the first quarter increased 67% over the first quarter of the prior year. It's a strong indicator of the traction we're gaining. We see the quarter as a launch readiness phase, gearing up to fully reignite our growth in Q2 and beyond, powered by a portfolio that is now fully ready to scale. Let me walk you through how our expanded portfolio has come together and how we're positioning the organization to capitalize on it effectively. In February, we launched RECELL GO mini, a targeted innovation designed specifically for trauma centers treating smaller wounds.

第一季的營收比去年同期成長了67%。這有力地表明了我們正在獲得發展動力。我們將本季視為發布準備階段，準備在第二季及以後全面重啟成長，並由現已完全準備好擴展的產品組合提供支援。讓我向您介紹我們擴大的產品組合是如何形成的，以及我們如何定位組織以有效地利用它。今年 2 月，我們推出了 RECELL GO mini，這是一項專為治療較小傷口的創傷中心設計的創新產品。

Let me step back for a moment and explain why we've created it. Our original RECELL system was developed to treat large burns covering up to 10% total body surface area or about 1,920 square centimeters. However, data from our pivotal trial to support our premarket approval of full-thickness skin defects for trauma and early market observations made it clear most traumatic wounds are significantly smaller, typically well under 480 square centimeters or less than 2.5% total body surface area that is treated by RECELL GO mini. In fact, during our PMA trial for non-thermal skin defects, the wound area treated was less than 2.5% total body surface area. What that told us is that outside of burn centers in trauma and surgical settings, wounds requiring grafting are predominantly smaller, yet our standard RECELL kit was optimized for much larger wounds.

讓我暫時退一步解釋一下我們為什麼要創建它。我們最初的 RECELL 系統是為治療覆蓋全身表面積 10% 或約 1,920 平方厘米的大面積燒傷而開發的。然而，我們支持上市前批准用於治療創傷的全層皮膚缺損的關鍵試驗數據和早期市場觀察表明，大多數創傷性傷口明顯較小，通常遠低於 480 平方厘米或不到 RECELL GO mini 可治療的總體表面積的 2.5%。事實上，在我們針對非熱皮膚缺損進行的 PMA 試驗期間，治療的傷口面積不到全身表面積的 2.5%。這告訴我們，在創傷和外科環境中的燒傷中心之外，需要移植的傷口大多較小，但我們的標準 RECELL 套件針對更大的傷口進行了優化。

Enter RECELL GO mini. Same RECELL GO multi-use processing device, same procedural consistency, same clinical benefits, but with a disposable cartridge optimized for trauma cases covering wounds up to 480 square centimeters. It is a purpose-built solution informed directly by real-world clinical needs and designed for optimal integration into trauma workflows. RECELL GO mini unlocks the trauma market of approximately 270,000 cases annually in the United States. The early feedback has been encouraging, and we're already seeing adoption.

進入 RECELL GO mini。相同的 RECELL GO 多用途處理設備、相同的程序一致性、相同的臨床益處，但配有針對創傷病例優化的一次性墨盒，可覆蓋面積達 480 平方厘米的傷口。它是一個專門構建的解決方案，直接根據現實世界的臨床需求而設計，旨在最佳地融入創傷工作流程中。RECELL GO mini 打開了美國每年約 27 萬例創傷市場。早期的回饋令人鼓舞，我們已經看到了採用。

We also launched Cohealyx, our collagen-based dermal matrix nationwide on April 1, 2025, in all sizes, following a successful limited release during Q1. For those new to the story, last quarter, we shared a standout case that took place at the Ohio State University Western Medical Center. In that case, a 67-year-old woman with a third degree burn was treated under physician direction using Cohealyx as part of the treatment protocol. By Day 7, her wound had progressed to a point the physician deemed ready for grafting. She was discharged within 10 days.

繼第一季成功限量發售後，我們也於 2025 年 4 月 1 日在全國推出了各種尺寸的基於膠原蛋白的真皮基質 Cohealyx。對於那些剛了解這個故事的人來說，上個季度我們分享了一個發生在俄亥俄州立大學西部醫學中心的突出案例。在該案例中，一名 67 歲三度燒傷女性在醫生指導下使用 Cohealyx 作為治療方案的一部分進行治療。到第 7 天，她的傷口已經發展到醫生認為可以進行移植的程度。她在10天後就出院了。

According to one of her clinicians, had she been treated with an alternative dermal matrix, her hospital stay would likely have extended to a month. Her treating physician also noted that Cohealyx not only reduced the time the patient spent in the hospital, but he believes it could allow physicians to treat more patients due to how easy it was to use in the operating room. In fact, the surgical team described Cohealyx as a welcome addition to their toolkit and emphasized its compatibility with their existing protocols. These initial experiences reflect the kind of clinical feedback we're hearing as adoption expands and is exactly the type of outcome other centers are looking for as they evaluate integration into their protocols. Cohealyx is now available in multiple sheet sizes, including a large format 700 square centimeter sheet.

據她的一位臨床醫生說，如果她接受另一種真皮基質治療，她的住院時間可能會延長至一個月。她的主治醫生還指出，Cohealyx 不僅減少了患者在醫院的時間，而且他相信，由於它在手術室中易於使用，醫生可以治療更多的患者。事實上，手術團隊將 Cohealyx 描述為他們工具包中受歡迎的補充，並強調其與他們現有協議的兼容性。這些初步經驗反映了我們在採用範圍擴大時聽到的臨床回饋類型，並且正是其他中心在評估融入其協議時所尋求的結果類型。Cohealyx 現提供多種紙張尺寸，包括 700 平方公分的大尺寸紙張。

Importantly, three large-format sheets cover the treatment area of a typical RECELL burn case of 1,920 square centimeters, enabling full coverage of the wound. To facilitate adoption and stocking, we are deploying Cohealyx through an RFID-enabled consignment model that streamlines hospital inventory management and ensures traceability to address important financial and regulatory considerations. In parallel, we have fully implemented the manufacturing of PermeaDerm, our biosynthetic dressing under our roof at our state-of-the-art facility in Ventura, California. Alongside this, we have amended our distribution agreement with Stedical Scientific. This strategic move delivers cost efficiencies, scale and a larger revenue share of the average selling price.

重要的是，三張大尺寸的紙張覆蓋了典型的 RECELL 燒傷病例的治療面積 1,920 平方厘米，從而能夠完全覆蓋傷口。為了促進採用和庫存，我們正在透過支援 RFID 的寄售模式部署 Cohealyx，以簡化醫院庫存管理並確保可追溯性，以解決重要的財務和監管問題。同時，我們在位於加州文圖拉的最先進的工廠內全面實施了生物合成敷料 PermeaDerm 的生產。除此之外，我們也修改了與 Stedical Scientific 的分銷協議。這項策略措施提高了成本效率、擴大了規模並增加了平均售價的收入份額。

60% of the revenue goes to AVITA, up from 50%. With these additions, our commercial lineup now includes RECELL Ease-of-Use, RECELL GO, RECELL GO mini, Cohealyx and PermeaDerm. This is the first time we've had such a broad spectrum of products available to support both burn and trauma centers, one broad integrated portfolio targeted at the same hospital, same doctor, the same patient and the same wound. This matters because hospitals are looking for integrated, scalable wound care solutions that solve more and more of their wound care needs. AVITA Medical provides that now.

60% 的收入歸 AVITA 所有，高於先前的 50%。有了這些產品，我們的商業陣容現在包括 RECELL Ease-of-Use、RECELL GO、RECELL GO mini、Cohealyx 和 PermeaDerm。這是我們第一次擁有如此廣泛的產品來支持燒傷和創傷中心，一個廣泛的綜合產品組合針對同一家醫院、同一位醫生、同一位患者和同一種傷口。這很重要，因為醫院正在尋找全面的、可擴展的傷口護理解決方案，以解決越來越多的傷口護理需求。AVITA Medical 現在提供此服務。

Slide 4 shows what that means in terms of potential revenue per case. As hospitals adopt across our portfolio, we expect the realized average selling price per case to rise meaningfully. Now to support our portfolio transformation, we needed to evolve our commercial model to match. This required a significant shift in our commercial approach. Historically, our reps provided heavy service-oriented case-based procedural support, meaning our clinical specialist staff or sales reps will be physically present for many RECELL cases.

投影片 4 顯示了這對每起案件的潛在收入意味著什麼。隨著醫院採用我們的產品組合，我們預計每個產品的實際平均售價將大幅上漲。現在，為了支持我們的投資組合轉型，我們需要改進我們的商業模式以適應。這要求我們在商業方法上做出重大轉變。從歷史上看，我們的代表提供了大量以服務為導向的基於案例的程序支持，這意味著我們的臨床專家人員或銷售代表將親自出席許多 RECELL 案例。

That model served us well during the initial introduction of this first-in-category product when we were a burn-only single product company. With the launch of multiple products and a more complex call point, we need to evolve our sales model. Robin VanDenburgh, who joined us last August, led a full evaluation of our commercial organization. Under her leadership, we've redesigned the model, shifting from a service-oriented case-based support structure to a more focused selling-oriented approach. Our reps still cover cases, but within a standard two-stage workflow for a full thickness case, typically around 10% total body surface area, they're now actively selling at multiple points throughout the two procedures.

當我們還是一家只生產單一產品的公司時，這種模式在首次推出這款同類產品的過程中發揮了很好的作用。隨著多種產品的推出和更複雜的通話點，我們需要改進我們的銷售模式。去年八月加入我們的 Robin VanDenburgh 領導了對我們商業組織的全面評估。在她的領導下，我們重新設計了模型，從以服務為導向的案例為基礎的支援結構轉變為更重視銷售導向的方法。我們的銷售代表仍然負責處理病例，但在標準的兩階段工作流程中，對於全層病例，通常佔全身表面積的 10% 左右，他們現在在兩個過程中的多個點積極銷售。

In Stage 1, they're introducing and selling the dermal matrix. Then in Stage 2, they're selling RECELL with split-thickness skin graft and closing the graft with PermeaDerm. Here's an overview of the changes we've made. We consolidated from 12 regions to 9 regions. We reduced our total field headcount from 108 to 82.

在第一階段，他們正在推出和銷售真皮基質。然後在第 2 階段，他們銷售帶有分層皮片移植的 RECELL，並使用 PermeaDerm 封閉移植。以下是我們所做更改的概述。我們將 12 個地區合併為 9 個地區。我們將現場工作人員總數從 108 人減少到 82 人。

We have transitioned most clinical specialists into commercial roles, preserving critical product knowledge while expanding our commercial reach. We didn't lose expertise. We redeployed our expertise. Now our sales reps are spending more time on conversations that drive adoption across the entire portfolio while still covering cases. We've realigned incentives accordingly.

我們已將大多數臨床專家轉變為商業角色，在擴大商業範圍的同時保留了關鍵的產品知識。我們並沒有失去專業知識。我們重新部署了我們的專業知識。現在，我們的銷售代表花費更多時間進行對話，以推動整個產品組合的採用，同時仍涵蓋案例。我們已經相應地重新調整了激勵措施。

We will continue to have a small single-digit number of clinical specialists generally assigned to our largest customers. As part of this evolution, we evaluated every program in the company created meaningful efficiencies. Overall, we expect to save $2.5 million per quarter in operating expenses and improve operating margin, all while increasing our selling capacity. Of that, approximately $1.3 million comes from the commercial transformation with the remainder from G&A and R&D savings. We also strengthened leadership in the process.

我們將繼續為我們最大的客戶分配少量的臨床專家。作為這一演變的一部分，我們評估了公司中每個創造有意義效率的項目。整體而言，我們預計每季營運費用可節省 250 萬美元，營運利潤率可提高，同時銷售能力也將提升。其中約 130 萬美元來自商業轉型，其餘則來自一般及行政費用和研發節省。我們也在過程中加強了領導。

Laura Ackerman has stepped into one of our two area Vice President of Sales roles reporting directly to Robin. It's the right team at the right time to meet the moment. Meanwhile, we're seeing reimbursement support continue to build. Earlier this month, CMS proposed a new technology add-on payment known as NTAP for RECELL. If approved, the policy could take effect on October 1.

勞拉·阿克曼 (Laura Ackerman) 已擔任我們兩個區域銷售副總裁職位之一，直接向羅賓 (Robin) 匯報工作。這是在正確的時間遇到正確的團隊來滿足這一需求。同時，我們看到報銷支援不斷增加。本月初，CMS 提出了一項名為 NTAP 的 RECELL 新技術附加付款方案。如果獲得批准，該政策將於10月1日生效。

We're optimistic, and we're actively engaged in the public comment process. As for vitiligo, our clinical studies were accepted for publication in March and the results met our expectations. That said the reimbursement landscape remains highly uncertain. As a consequence, we are stepping back from further commercial investment in the vitiligo indication at this time. Our focus remains squarely on acute wound care, where we see the greatest and clearest opportunity.

我們很樂觀，並且積極參與公眾評論過程。至於白斑症，我們的臨床研究在三月被接受發表，結果符合我們的預期。儘管如此，報銷前景仍高度不確定。因此，我們目前不再對白斑症進行進一步的商業投資。我們的重點仍然放在急性傷口護理上，我們看到了最大、最明顯的機會。

Let me end by looking ahead. We've come a long way. Two years ago, we were focused solely on burns addressing a $500 million market opportunity. Today, with a broad acute wound care portfolio, our addressable market is in excess of $3.5 billion in the U.S. alone, backed by a scalable commercial model, integrated operations and expanding reimbursement support.

最後，請容許我展望一下未來。我們已經走了很長一段路。兩年前，我們專注於燒傷治療，以獲得 5 億美元的市場機會。如今，憑藉廣泛的急性傷口護理產品組合，我們僅在美國的潛在市場就超過 35 億美元，並由可擴展的商業模式、綜合運營和不斷擴大的報銷支援提供支援。

Our future is bright. On May 13, we will bring this story to life at the AVITA Medical Acute Wound Care Showcase 2025. We'll share clinical results by some of our treating physicians, economic insights, and we will hear how our products have changed patients' lives. You'll be hearing directly from the physicians and patients whose lives they've helped heal. I hope you'll join us.

我們的未來是光明的。5 月 13 日，我們將在 2025 年 AVITA 醫療急性傷口照護展示會上重現這個故事。我們將分享一些主治醫師的臨床結果、經濟見解，並了解我們的產品如何改變病人的生活。您將直接聽到那些他們幫助治癒過生命的醫生和患者的聲音。我希望你能加入我們。

You can register by visiting our website, clicking the Investor Relations tab and selecting the Events section. With that, I'll turn it over to David to walk through our financial results.

您可以透過造訪我們的網站、點擊「投資者關係」標籤並選擇「活動」部分進行註冊。接下來，我將把時間交給大衛來介紹我們的財務表現。

Thank you, Jim. For the three months ended March 31, 2025, our commercial revenue was $18.5 million, representing a 67% increase compared to the same period in 2024. This growth was driven primarily by the continued deployment and ongoing adoption of RECELL GO within existing burn centers as well as expansion of new accounts targeting trauma centers. We acknowledge that we have had two quarters where our revenue has been flat. However, as Slide 5 shows, over the last 5 years, our growth has been impressive with approximately 47% compound annual growth rate through the end of 2025, assuming the midpoint of our revenue guidance for this year.

謝謝你，吉姆。截至 2025 年 3 月 31 日的三個月，我們的商業收入為 1,850 萬美元，與 2024 年同期相比成長 67%。這一增長主要得益於現有燒傷中心持續部署和採用 RECELL GO，以及針對創傷中心的新帳戶擴展。我們承認，我們的營收已經有兩個季度持平。然而，如幻燈片 5 所示，在過去 5 年中，我們的成長令人印象深刻，假設今年的營收預期為中點，到 2025 年底的複合年增長率約為 47%。

As Jim indicated, we are on the precipice of recharging this historical growth rate in the coming quarters. Early indicators from the February launch of RECELL GO mini and April launch of Cohealyx continue to suggest that these products will meaningfully contribute to revenue growth throughout 2025, alongside the increasing momentum from PermeaDerm sales. Gross profit margin for the first quarter was 84.7%, down from 86.4% during the same period of 2024. Note that the gross margin for RECELL products only was 86.4% for the quarter, which we believe will remain in this range for future quarters. The decrease in the overall gross margin percentage from the prior year was primarily caused by volume discounts, a higher inventory reserve and product mix.

正如吉姆所指出的，我們即將在未來幾季重新達到這段歷史成長率。2 月推出的 RECELL GO mini 和 4 月推出的 Cohealyx 的早期指標繼續表明，隨著 PermeaDerm 銷售勢頭的增長，這些產品將在 2025 年全年為收入增長做出重大貢獻。第一季毛利率為84.7%，低於2024年同期的86.4%。請注意，本季 RECELL 產品的毛利率僅為 86.4%，我們相信未來幾季的毛利率將維持在這個範圍內。整體毛利率較上年同期下降主要由於批量折扣、庫存儲備增加及產品組合變化所致。

As the percentage of our revenue derived from new products increases, we will continue to see a small degradation of our overall gross margin percentage while increasing our gross margin dollars and operating dollars. As we have disclosed, we share the average sales price for Cohealyx at 50% and for PermeaDerm at 60%. These distribution arrangements are highly beneficial to us. However, it is inevitable because of the revenue-sharing nature that our overall gross margin percentage will decrease from historical levels. Total operating expenses for the quarter totaled $27.5 million compared to $26.8 million in the same period of 2024.

隨著我們來自新產品的收入比例的增加，我們將繼續看到整體毛利率百分比的小幅下降，同時增加我們的毛利率和營業收入。正如我們所揭露的，我們分享 Cohealyx 50% 的平均銷售價格，分享 PermeaDerm 60% 的平均銷售價格。這些分配安排對我們非常有利。然而，由於收入分成的性質，我們的整體毛利率百分比不可避免地會從歷史水準下降。本季總營運費用為 2,750 萬美元，而 2024 年同期為 2,680 萬美元。

This increase stemmed from a $2.2 million rise in sales and marketing expenses due to employee-related costs, including increases in salaries and benefits and commissions, partially offset by a decrease in professional fees. G&A expenses decreased significantly by $2.6 million or 29%, driven by lower salaries and benefits, deferred compensation, professional fees and corporate expenses. R&D expenses increased by $1.1 million as a result of higher salaries and benefits, stock-based compensation, partially offset by lower outside professional fees and other expenses. Notably, due to our recent commercial field transformation and additional operational efficiencies we have implemented, we expect to reduce our operating expenses by approximately $2.5 million per quarter on a go-forward basis. We expected total operating expenses to increase in the first quarter compared to total operating expenses of $26.1 million in the fourth quarter of 2024 due to the reset of payroll taxes, benefits and other typical first quarter expenses.

這一增長源於銷售和行銷費用增加 220 萬美元，原因是員工相關成本（包括工資、福利和佣金增加），但專業費用減少部分抵消了這一增長。由於薪資福利、遞延薪資、專業費用和公司費用減少，一般及行政費用大幅減少 260 萬美元，降幅為 29%。由於工資和福利以及股票薪酬增加，研發費用增加了 110 萬美元，但外部專業費用和其他費用的降低部分抵消了增加。值得注意的是，由於我們最近實施的商業領域轉型和額外的營運效率，我們預計未來每季的營運費用將減少約 250 萬美元。由於工資稅、福利和其他典型的第一季費用的重新設定，我們預計第一季的總營運費用將比 2024 年第四季的 2,610 萬美元的總營運費用增加。

The $27.5 million of operating expenses in the first quarter include noncash expenses of approximately $2.7 million of stock-based compensation expense and approximately $0.4 million of depreciation and amortization. Other income expense increased by $0.7 million to $0.8 million of expense for the quarter, consisting of noncash charges totaling $1.1 million related to changes in fair value of debt and $0.5 million of associated debt costs, partially offset by a $0.4 million noncash gain from the change in fair value of warrant liabilities and $0.4 million in investment income. Net loss for the first quarter was $13.9 million or a loss of $0.53 per basic and diluted share, improving from a net loss of $18.7 million or a loss of $0.73 per basic and diluted share in the same period in 2024. As of March 31, we had cash and marketable securities of $25.8 million compared to $35.9 million at December 31, 2024. Although we expected our cash usage to increase in the first quarter due to payment of bonuses and commissions as well as the reset of payroll taxes and benefits, the $10.1 million use of cash was higher than we had anticipated.

第一季的 2,750 萬美元營運費用包括約 270 萬美元的股票薪資費用和約 40 萬美元的折舊和攤提非現金費用。本季其他收入支出增加了 70 萬美元，達到 80 萬美元，其中包括與債務公允價值變動相關的總計 110 萬美元的非現金費用以及 50 萬美元的相關債務成本，但被認股權證負債公允價值變動產生的 40 萬美元非現金收益和 40 萬美元的投資收益部分抵銷。第一季淨虧損為 1,390 萬美元，即每股基本虧損和稀釋虧損均為 0.53 美元，較 2024 年同期的淨虧損 1,870 萬美元或每股基本虧損和稀釋虧損均為 0.73 美元有所改善。截至 3 月 31 日，我們的現金和有價證券為 2,580 萬美元，而 2024 年 12 月 31 日為 3,590 萬美元。儘管我們預計第一季的現金使用量會因支付獎金和佣金以及重新設定工資稅和福利而增加，但 1,010 萬美元的現金使用量高於我們的預期。

As discussed earlier, we have taken the necessary steps to reduce our use of cash in the coming quarters by eliminating approximately $2.5 million of operating expenses per quarter. We remain confident that our current cash balance will allow us to achieve our plan, which includes generating free cash flow in the second half of the year and achieving GAAP profitability in Q4 of this year. Turning to our OrbiMed credit facility; at the end of March, we secured a waiver of our first quarter trailing 12-month revenue covenant, which had been set at $73 million. To obtain this waiver, we paid a fee to OrbiMed. Revenue covenants for future quarters remain intact with the second quarter 2025 trailing 12-month revenue covenant set at $78 million.

如前所述，我們已採取必要措施，透過每季削減約 250 萬美元的營運費用來減少未來幾季的現金使用。我們仍然相信，我們目前的現金餘額將使我們能夠實現我們的計劃，其中包括在今年下半年產生自由現金流並在今年第四季度實現 GAAP 盈利。談到我們的 OrbiMed 信貸安排；3 月底，我們獲得了第一季過去 12 個月收入契約的豁免，該契約原定為 7,300 萬美元。為了獲得此項豁免，我們向 OrbiMed 支付了一筆費用。未來幾季的收入契約保持不變，2025 年第二季接下來 12 個月的收入契約設定為 7,800 萬美元。

It is worth highlighting that we have assessed potential implications of current tariff policies and can state the current slate of tariffs will not have a material impact on our business. Looking ahead, we reiterate our full year 2025 commercial revenue guidance of $100 million to $106 million, representing growth of approximately 55% to 65% compared to 2024. Additionally, we continue to expect to generate free cash flow in the second half of the year and achieve GAAP profitability during Q4 of 2025, supported by our operating efficiencies as well as the broader scaling of our commercial portfolio. We remain confident in the success of RECELL GO, the full commercial launch of Cohealyx, the rollout of RECELL GO mini and the growing adoption of PermeaDerm. These strategic initiatives position us to deliver strong results this year and drive significant shareholder value.

值得強調的是，我們已經評估了當前關稅政策的潛在影響，並且可以聲明當前的關稅不會對我們的業務產生重大影響。展望未來，我們重申 2025 年全年商業收入預期，即 1 億美元至 1.06 億美元，與 2024 年相比增長約 55% 至 65%。此外，由於我們的營運效率以及商業組合的更廣泛擴展，我們仍然預計在今年下半年產生自由現金流，並在 2025 年第四季實現 GAAP 盈利。我們對於 RECELL GO 的成功、Cohealyx 的全面商業發布、RECELL GO mini 的推出以及 PermeaDerm 的日益普及充滿信心。這些策略舉措使我們今年能夠取得強勁業績並創造顯著的股東價值。

Lastly, as a reminder, our Annual Meeting of Stockholders will be held on June 4. We encourage all stockholders to participate and cast their votes. With that, I will turn the call back to the operator for your questions.

最後，提醒一下，我們的年度股東大會將於 6 月 4 日舉行。我們鼓勵所有股東參與並投票。說完這些，我會將電話轉回給接線生，以便回答您的​​問題。

(Operator Instructions)

（操作員指示）

Brooks O'Neil, Lake Street Capital Markets.

布魯克斯‧歐尼爾 (Brooks O'Neil)，湖街資本市場 (Lake Street Capital Markets)。

I guess I'll start. I have a sense that you've said a limited commercial launch of Cohealyx occurred in Q1. Can you share anecdotally any response, impressions, performance you've witnessed of that product and [ sense ] to you about the pending full launch that's occurring now.

我想我應該開始了。我感覺您說過 Cohealyx 在第一季進行了有限的商業發布。您能否分享您對該產品的任何反應、印象、性能以及即將進行的全面發布給您的[感覺]。

Sure can, Brooks. Thanks for the question. So first of all, we -- you may recall that the preclinical work demonstrated a graft readiness at 7 days, which is quite almost 7 to 14 days faster than other dermal matrixes that we studied in that same preclinical work. What we experienced in the limited market release was really us gathering case data to help support commercialization April 1, is we actually validated that experience. And there was a case that's in the news put out by Ohio State, where they had a 7-day graft-ready experience with Cohealyx.

當然可以，布魯克斯。謝謝你的提問。首先，您可能還記得，臨床前研究表明，移植在 7 天內即可完成，這比我們在同一臨床前工作中研究的其他真皮基質快了 7 到 14 天。我們在有限的市場發布中所經歷的實際上是我們收集案例數據以幫助支持 4 月 1 日的商業化，我們實際上驗證了這一經驗。新聞中也報導了俄亥俄州立大學的一個案例，他們使用 Cohealyx 進行了 7 天的移植準備體驗。

And it was -- that is consistent with the -- a couple of dozen cases that we did during Q1. In Q1, we didn't have a broad full SKU array of sizes. So we were limited to treat certain number of -- certain size of cases. On April 1, we are fully stocked, including the 700 square centimeter sheets. So we're fully ready to go.

這與我們在第一季處理的幾十起案件一致。在第一季度，我們沒有廣泛且完整尺寸的 SKU 陣列。所以我們只能治療一定數量或一定規模的病例。4月1日，我們的庫存已滿，包括700平方公分的床單。所以我們已經做好了充分的準備。

So the third thing is Cohealyx 1 on our post-market study is in the majority ready to enroll. They've been through IRB. And right now, they're screening patients and preparing to enroll. So during the year, we'll get access to that data as well. So since that time, we've had a number of early commercial adoption cases where they've been through VAC already, shorter than we were experiencing, frankly, with RECELL GO times.

第三件事是，我們上市後研究中的 Cohealyx 1 大多數都已準備好招募。他們已經通過了 IRB。目前，他們正在篩選患者並準備招募。因此，在這一年中，我們也將獲得這些數據。因此，從那時起，我們已經有了許多早期的商業採用案例，這些案例已經經歷了 VAC，坦白說，比我們經歷的 RECELL GO 時間要短。

So we're really excited about how Cohealyx is going. The organization is trained. And as you heard, we reconfigured the sales organization as well because, of course, Cohealyx gets sold at the first stage of a two-stage procedure. And we want our reps there as well as when RECELL GO or RECELL GO mini is being used with a split-thickness skin graft. So a lot of info.

因此，我們對 Cohealyx 的發展感到非常興奮。該組織接受了培訓。正如您所聽到的，我們也重新配置了銷售組織，因為 Cohealyx 當然是在兩階段程序的第一階段出售的。我們希望我們的代表能夠在那裡，就像 RECELL GO 或 RECELL GO mini 與分層皮膚移植一起使用一樣。有很多資訊。

So sorry about that, but there's a lot to say about Cohealyx.

對此我深感抱歉，但關於 Cohealyx 還有很多話要說。

Great. That was very helpful, Jim. So the other question I want to ask is just, obviously, RECELL GO mini and the expansion of the product into the Level 1 and Level 2 trauma centers. I'm curious if you could give us just any sense for whether that's working and what the response is.

偉大的。這非常有幫助，吉姆。所以我想問的另一個問題顯然是 RECELL GO mini 以及該產品向 1 級和 2 級創傷中心的擴展。我很好奇您是否可以告訴我們這是否有效以及反應如何。

So first of all, we had our -- although the product was approved at the end of December, our first inventory was in early February. So that was our first promotion time. We've had a fair -- I would say a good response from existing VAC approved accounts that were in the trauma area that we had converted last year who've taken in inventory for RECELL GO mini. It's a real important distinction that those patients are way in the majority under that 2.5% total body surface area that RECELL GO mini covers, which is 480 square centimeters. So the response is good.

首先，儘管產品在 12 月底獲得批准，但我們的第一批庫存是在 2 月初。那是我們的第一次促銷。我們得到了公平的——我想說，來自現有 VAC 批准帳戶的良好反響，這些帳戶屬於我們去年轉換的創傷領域，並且已經對 RECELL GO mini 進行了盤點。一個非常重要的區別是，這些患者中的大多數都低於 RECELL GO mini 覆蓋的 2.5% 總體表面積，即 480 平方厘米。所以反應很好。

And you know what else we've noticed is we -- with the portfolio as we now have it with PermeaDerm and Cohealyx and RECELL GO mini, there's more opportunities to provide value to the trauma surgeon. So it is making a difference on our selling activity.

而且您知道我們還注意到了什麼嗎？憑藉我們目前擁有的 PermeaDerm、Cohealyx 和 RECELL GO mini 產品組合，我們有更多機會為創傷外科醫生提供價值。因此，它對我們的銷售活動產生了影響。

(Operator Instructions)

（操作員指示）

Josh Jennings, TD Cowen.

喬許‧詹寧斯 (Josh Jennings)，TD Cowen。

This is [Eric] on for Josh. Thank you for all the commentary on Cohealyx. That's very helpful. And it sounds like that rollout is off to a nice start. I was hoping we could talk about any potential revenue contributions from that launch that we should be assuming within the guidance for '25.

我是 [Eric]，為 Josh 服務。感謝大家對 Cohealyx 的評論。這非常有幫助。聽起來這次推廣有一個好的開始。我希望我們可以談論一下此次發布可能帶來的任何收入貢獻，我們應該在 25 年的指導範圍內假設這些貢獻。

And maybe beyond that, just wondering if you have any target attachment rates that you're working towards where folks are using Cohealyx in concert with the RECELL platform.

除此之外，您可能還想知道您是否正在努力實現任何目標附著率，即人們將 Cohealyx 與 RECELL 平台結合使用。

That is a good question. We're not quite ready to give guidance on that mix. I will tell you, it is expected by us to be a material contributor. We think, in fact, it is likely that by Q3 that we'll be breaking out the non-RECELL sales as a consequence, just to give you some directional guidance, if that's helpful.

這是個好問題。我們還沒有準備好針對這個組合給予指導。我會告訴你，我們希望它成為一個實質的貢獻者。事實上，我們認為，到第三季度，我們很可能會公佈非 RECELL 銷售額，只是為了給您一些方向性的指導，如果這有幫助的話。

That is, yeah. And maybe secondly, just thinking about the sales force here, just looking at where revenues need to be by the end of this year to reach guidance. I was just wondering if you think you have the sales force in place now to reach those targets or if that's something that needs to be looked at, at some point here?

是啊。其次，也許只考慮這裡的銷售人員，只看今年年底的收入需要達到什麼水準才能達到預期。我只是想知道，您是否認為現在的銷售團隊已經到位，可以實現這些目標，或者是否需要在某個時候再考慮這一點？

No. Actually, we feel very good about our staffing level. We reconfigured because if you recall, we were -- structurally, we had, I think, 59 sales positions and 29 clinical specialist positions. And those clinical specialist positions were attached to sales reps, right? And the model very much was heavily a sales service model.

不。事實上，我們對我們的人員配備水準感到非常滿意。我們進行了重新配置，因為如果您還記得的話，我們——從結構上講，我們有 59 個銷售職位和 29 個臨床專家職位。那些臨床專家職位是屬於銷售代表的，對嗎？此模式很大程度上是一種銷售服務模式。

And in a two-stage procedure, the sales rep -- I mean, the clinical specialists, not the sales rep would be present. And of course, during the initial stage, there was no explicit reason why our rep would be present. So what we did is we have a number of very large accounts where we kept the clinical specialist model. We converted the roles of clinical specialists into a -- essentially a sales associate level, we call them market development specialists, but they have a sales role. And so now our sales coverage is about approximately 70 -- and their goal is to be a selling team that is in Stage 1 of the procedure when a dermal matrix is potentially used and then to also be there when the split-thickness skin graft is used with RECELL and be there when the dressing that could be PermeaDerm would be applied.

在兩階段程序中，銷售代表－我的意思是臨床專家，而不是銷售代表會在場。當然，在最初階段，並沒有明確說明我們的代表為何出席。因此，我們所做的就是，我們擁有許多非常大的帳戶，並在其中保留了臨床專家模型。我們將臨床專家的角色轉變為——本質上是銷售助理級別，我們稱他們為市場開發專家，但他們具有銷售角色。因此，現在我們的銷售覆蓋範圍大約為 70 人——他們的目標是成為一支銷售團隊，在手術第 1 階段可能使用真皮基質時，以及在使用 RECELL 進行分層皮片移植時，以及在使用可能是 PermeaDerm 的敷料時，都能夠提供服務。

So it's a much more selling-oriented model, and we trained on that during the first quarter and early in April. So that is something that we've been preparing with this portfolio expansion.

因此，這是一個更以銷售為導向的模式，我們在第一季和四月初對此進行了培訓。這就是我們為擴大投資組合所做的準備。

Understood. That makes sense. And if I could squeeze one last question, maybe for David here. Just thinking about the cadence of revenues through the rest of this year, should we be expecting just steady sequential increases through 2Q, 3Q, 4Q or is this going to be more heavily weighted towards those end of the year quarters as some of the new offerings in the pipeline begin to contribute?

明白了。這很有道理。如果我可以再問最後一個問題，也許是問大衛。想想今年剩餘時間的營收節奏，我們是否應該預期第二季、第三季、第四季的營收會穩定成長，還是會更偏向年底的幾個季度，因為一些正在籌備中的新產品開始做出貢獻？

Yeah. I think that -- thank you for the question. I appreciate that. The way we model it is there's more just sequential growth every quarter with some weighted towards the back end. You can imagine that as we get more VAC approvals, especially for Cohealyx, which is going to be a major contributor for us for this year and into next year.

是的。我認為——感謝您的提問。我很感激。我們建模的方式是每個季度都有更多的連續成長，其中一些成長偏向後端。你可以想像，隨著我們獲得更多的 VAC 批准，特別是對 Cohealyx 的批准，它將成為我們今年和明年的主要貢獻者。

So as we get more VAC approvals with Cohealyx that will be towards the back end of the year that, that will take off. But overall, kind of an even sequential growth is what we're looking to do for the rest of the year.

因此，隨著我們在今年年底獲得更多 Cohealyx 的 VAC 批准，這項計劃將會起飛。但總體而言，我們希望在今年剩餘時間內實現連續的平穩成長。

Chris Kallos, MST Access.

Chris Kallos，MST Access。

Hi Jim. I just wanted to ask some clarifying point on the vitiligo initiative. So could you just maybe just clarify where exactly that stands at the moment in terms of pursuing reimbursement?

你好，吉姆。我只是想問一些有關白斑症倡議的澄清問題。那麼，您能否澄清一下，目前尋求報銷的具體情況是什麼？

Yeah, Chris, I can. Good to hear from you. So what we've done is we have made a decision to pause spending on vitiligo because of the uncertainty of achieving reimbursement in the -- it's called the office-based lab setting, which is a physician's office. That's where the market desire to treat is and RECELL is not reimbursed for vitiligo is there only in the hospital. And as a consequence of our expanded opportunity in therapeutic acute wound care and the big opportunity we have there, we've decided that the best use of our resources is to build that market.

是的，克里斯，我可以。很高興收到你的來信。因此，我們決定暫停白斑症治療費用的支出，因為在所謂的辦公室實驗室環境中，也就是醫生的辦公室，無法獲得報銷。這就是市場治療需求所在，RECELL 不適用於僅在醫院治療的白斑症。由於我們在治療性急性傷口護理領域的機會不斷擴大，並且我們擁有巨大的機遇，我們決定最好地利用我們的資源來建立這個市場。

So as of now, we don't have a plan to -- that we can define for solving vitiligo. And -- so we don't have a plan that we can define. And therefore, we've suspended spending as a consequence until we identify a path.

所以到目前為止，我們還沒有製定解決白斑症的計畫。因此，我們還沒有一個可以製定的計劃。因此，我們暫停了支出，直到找到解決辦法。

Reimbursement agencies?

報銷機構？

I'm sorry.

對不起。

And that would include ongoing discussions now been suspended with reimbursement agencies?

這是否包括目前與報銷機構暫停的持續討論？

Since we talk with them on other reimbursement matters, we'll be talking to them about this. So it's not an absolute zero. But I'd say that there should be no revenue dependence in any future estimates for the company on vitiligo until we come forth with some defined plan.

由於我們與他們討論了其他報銷事宜，因此我們也會與他們討論此事。所以它不是絕對零。但我想說，在我們制定明確的計畫之前，公司未來的任何估計都不應該將收入依賴性放在白斑症上。

And I'm showing no further questions in the Q&A queue at this time. I will now turn the call back over to Mr. Jim Corbett for any closing remarks.

目前，問答隊列中沒有其他問題。現在我將把電話轉回給吉姆·科比特先生，請他做最後發言。

Thank you, operator, and thanks to those of you listening. We really appreciate your interest in AVITA Medical. I hope you have the time to join the AVITA showcase, reminding you that you can go to our website, click on the Investor tab and register for it, which is scheduled for next Tuesday, U.S. time. And we hope to see you there.

謝謝接線員，也感謝各位聽眾。我們非常感謝您對 AVITA Medical 的關注。我希望您有時間參加 AVITA 展示會，提醒您可以訪問我們的網站，點擊「投資者」標籤並註冊，該活動定於下週二（美國時間）舉行。我們希望在那裡見到您。

We think we've got a really interesting program for you and thank you very much.

我們認為我們為您準備了一個非常有趣的節目，非常感謝您。

This concludes today's conference call. Thank you for your participation and you may now disconnect.

今天的電話會議到此結束。感謝您的參與，您現在可以斷開連接。