AVITA Medical Inc (RCEL) 2025 Q3 法說會逐字稿

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

您好，感謝您的耐心等待。歡迎參加 AVITA Medical, Inc. 2025 年第三季財報電話會議。（操作人員指示）請注意，今天的會議正在錄音。

I would now like to hand the conference over to your first speaker today, Ben Atkins. Please go ahead.

現在我謹將會議交給今天的第一位發言人，本·阿特金斯。請繼續。

Thank you, operator. Welcome to AVITA Medical's third-quarter 2025 earnings call. Joining me on today's call are Cary Vance, Interim 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.

謝謝接線生。歡迎參加AVITA Medical 2025年第三季財報電話會議。今天與我一起參加電話會議的有臨時執行長 Cary Vance 和財務長 David O'Toole。今天的收益報告和簡報可在我們網站 www.avitamedical.com 的「投資者關係」欄位下找到。

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. Any forward-looking statements provided during this call are based on management's expectations as of today.

在開始之前，我想提醒各位，本次電話會議包含1995年《私人證券訴訟改革法案》所界定的前瞻性陳述。這些聲明既不承諾也不保證，並且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中明示或暗示的任何預期有重大差異。請查閱我們最近向美國證券交易委員會提交的文件，以取得風險因素的詳細說明。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日的預期。

I will now turn the call over to Cary.

現在我將把電話轉給凱瑞。

Good afternoon in the US, and good morning in Australia. It's great to be with you today. As this is my first earnings call as Interim CEO, I want to begin by saying how much I appreciate the opportunity to speak directly with our investors, employees and clinical partners who make AVITA's mission to transform acute wound care possible. I've been with AVITA as a Board member for the past 2.5 years. And now, stepping into the Interim CEO role, I see the company with new eyes, but also with deep conviction.

美國下午好，澳洲早安。今天能和你們在一起真是太好了。由於這是我作為臨時執行長的第一次財報電話會議，我想先表達我對有機會直接與我們的投資者、員工和臨床合作夥伴對話的感激之情，正是他們的支持使 AVITA 改變急性傷口護理的使命成為可能。過去兩年半以來，我一直擔任AVITA的董事會成員。現在，我擔任臨時執行長一職，以全新的視角看待公司，同時也充滿信心。

AVITA's purpose is meaningful, its people are talented and its products are transformative. My job and our collective focus is to turn that potential into consistent performance where mission, execution and shareholder value align.

AVITA 的宗旨意義非凡，其員工才華橫溢，其產品具有變革性。我的工作和我們共同的目標是將這種潛力轉化為持續的業績，使使命、執行和股東價值保持一致。

Let's be clear, this has been a challenging quarter. We reported approximately $17 million in revenue, below expectations and reflecting the ongoing impact of reimbursement disruption that began earlier in the year. We now expect full year revenue in the range of $70 million to $74 million, down from our prior guidance of $76 million to $81 million.

坦白說，這確實是一個充滿挑戰的季度。我們公佈的收入約為 1700 萬美元，低於預期，反映了年初開始的報銷中斷的持續影響。我們現在預計全年營收將在 7,000 萬美元至 7,400 萬美元之間，低於先前預期的 7,600 萬美元至 8,100 萬美元。

As a reminder, in January, new Category I CPT codes for the use of RECELL took effect. Because CMS did not assign national clinical payment rates for these codes, responsibility for establishing payments fell to the regional Medicare Administrative Contractors, or MACs.

提醒一下，1 月份，RECELL 的新 I 類 CPT 代碼已生效。由於 CMS 沒有為這些代碼指定全國臨床支付標準，因此確定支付的責任落到了區域醫療保險管理承包商 (MAC) 身上。

The time required for each MAC to set rates and begin adjudicating claims created uncertainty, and providers awaited confirmation of reimbursement for RECELL procedures. As a result, many providers were unsure when or how claims for RECELL procedures would be paid.

每個 MAC 制定費率和開始裁決索賠所需的時間造成了不確定性，醫療服務提供者等待 RECELL 手術的報銷確認。因此，許多醫療機構不確定何時或如何支付 RECELL 手術的費用。

The good news is that significant progress has been made. As of today, all seven MACs have now published or confirmed acceptance of provider reimbursement rates, providing clinicians with clarity and confidence of payment when using RECELL. We're already seeing early signs of renewed demand, and we expect utilization to normalize progressively through the coming quarters. With provider reimbursement now largely resolved, RECELL's value is increasingly recognized across data, adoption, payment and policy.

好消息是，已經取得了顯著進展。截至今日，所有七個 MAC 均已公佈或確認接受提供者報銷率，使臨床醫生在使用 RECELL 時能夠清楚地了解付款情況並充滿信心。我們已經看到需求復甦的早期跡象，預計未來幾季利用率將逐步恢復正常。隨著醫療服務提供者的報銷問題基本上得到解決，RECELL 的價值在數據、採用、支付和政策方面越來越受到認可。

At the foundation, there is powerful real-world evidence, clinical and economic data showing the ability of RECELL to optimize healing, reduce donor-site burden and shorten hospital stays. Inclusion of the CPT codes for the RECELL procedure within the CMS payment system establishes a clear pathway for clinician reimbursement. Predictable reimbursement now restores clinicians' confidence in payment. Together, these layers help fuel adoption as clinicians and hospitals integrate RECELL into routine practice.

基金會擁有強大的真實世界證據、臨床和經濟數據，證明 RECELL 能夠優化癒合、減輕捐贈部位負擔並縮短住院時間。將 RECELL 手術的 CPT 代碼納入 CMS 支付系統，為臨床醫生報銷建立了一條清晰的途徑。可預測的報銷機制恢復了臨床醫生對支付的信心。這些層級共同促進了臨床醫生和醫院將 RECELL 整合到日常實踐中的應用。

For example, building on the strong clinical evidence, including data showing 36% reduction in hospital length of stay, one of the nation's leading burn centers has now incorporated RECELL into its treatment protocol for burns under 20% total body surface area. This is a clear example of how strong data, clinical experience and reimbursement clarity come together to make RECELL a standard point of care.

例如，基於強有力的臨床證據（包括顯示住院時間縮短 36% 的數據），美國領先的燒傷中心之一現已將 RECELL 納入其治療方案中，用於治療體表面積小於 20% 的燒傷。這清楚地表明，強大的數據、臨床經驗和明確的報銷政策如何結合在一起，使 RECELL 成為標準的護理點。

I can also share that since RECELL GO received CE Mark approval in Europe in September, we saw the first patient outside of the US treated with the device in Germany just last week. It's an important milestone that broadens access to our RECELL technology and underscores its global relevance.

我還可以透露，自 RECELL GO 於 9 月在歐洲獲得 CE 標誌批准以來，就在上週，我們在德國迎來了美國以外的第一位使用該設備進行治療的患者。這是一個重要的里程碑，它擴大了我們RECELL技術的應用範圍，並凸顯了其全球相關性。

While this quarter reflected the impact of reimbursement timing, it was also shaped by the pace of hospital Value Analysis Committee, or VAC, reviews and the evolution of our commercial organization. These factors collectively limited our near-term results and not the strength of our strategy or the quality of our products. In my first few weeks, I've spent time listening to our teams, to clinicians, our hospital partners and to shareholders. Their feedback has been candid and consistent. Our products are exceptional, but our performance hasn't always matched their potential.

雖然本季反映了報銷時間的影響，但也受到醫院價值分析委員會（VAC）審查速度和我們商業組織發展的影響。這些因素共同限制了我們近期的業績，而不是我們的策略實力或產品品質。在最初的幾周里，我花時​​間傾聽了我們團隊、臨床醫生、醫院合作夥伴和股東的意見。他們的回饋一直坦誠且一致。我們的產品非常出色，但我們的表現卻無法始終與其潛力相匹配。

RECELL, Cohealyx and PermeaDerm make a real difference in acute wound care. And now, it's on us to ensure hospitals can put these products into the hands of their clinicians, and most importantly, on to their patients. That's where my focus is, turning potential into consistent, reliable performance.

RECELL、Cohealyx 和 PermeaDerm 在急性傷口護理方面發揮著真正的作用。現在，我們有責任確保醫院能夠將這些產品送到臨床醫生手中，更重要的是，送到病人手中。我的工作重點就在於此，將潛力轉化為持續、可靠的表現。

Under my leadership, we've moved quickly to refine our commercial organization, aligning structure, territories and accountability around our highest value accounts. These adjustments are improving focus, visibility of customer behavior and the coordination between our sales and clinical teams. To that end, we've taken a fresh look at our market opportunity to better align our go-to-market strategy with observed customer behavior.

在我的領導下，我們迅速改進了商業組織架構，圍繞著我們最有價值的客戶調整了組織結構、業務範圍和責任歸屬。這些調整提高了我們的專注度、客戶行為的可見度以及銷售團隊和臨床團隊之間的協調性。為此，我們重新審視了市場機遇，以便更好地將我們的市場進入策略與觀察到的客戶行為相匹配。

Historically, we've shared that across all US burn and trauma hospitals, the total addressable market, or TAM, for AVITA's portfolio is about $3.5 billion, and that long-term opportunity remains unchanged. What has evolved is our understanding of where meaningful scalable use occurs. Roughly 90% of our revenue today comes from about 200 burn centers and trauma hospitals, core institutions that define acute wound care in the US. These represent our most immediate and scalable growth potential.

從歷史數據來看，我們曾表示，在美國所有燒傷和創傷醫院中，AVITA 產品組合的總潛在市場（TAM）約為 35 億美元，而且這一長期機會依然不變。我們對有意義的可擴展應用發生在哪裡的理解已經改變了。目前，我們約 90% 的收入來自約 200 家燒傷中心和創傷醫院，這些核心機構定義了美國的急性傷口護理。這些代表了我們最直接、最具規模化成長潛力的領域。

You'll see in the slide that this focus segment represents $1.3 billion in targeted opportunity within a broader $3.5 billion US market. We're currently serving about 5% of that segment, giving us significant runway for penetration and growth. In other words, this focus allows us to prioritize the hospitals and surgeons where our relationships are strongest and where we know adoption, utilization and cost portfolio expansion can be scaled most effectively. With this focus established, our execution priorities for the fourth quarter are clear.

您將在幻燈片中看到，這個重點細分市場代表著美國35億美元大市場中13億美元的目標市場機會。我們目前服務於該細分市場約 5% 的份額，這為我們提供了巨大的滲透和成長空間。換句話說，這種重點使我們能夠優先考慮與我們關係最密切的醫院和外科醫生，以及我們知道可以最有效地擴大採用率、利用率和成本組合擴展範圍的醫院和外科醫生。在確定了這一重點之後，我們第四季的執行重點就很明確了。

First, rebuild order momentum. With reimbursement clarity for use of RECELL returned, our commercial organization has a focused plan to reengage accounts that lowered their use of RECELL. This is back to basics execution, targeted outreach, disciplined follow-up and strong field accountability to deliver steady volume recovery.

首先，重建秩序勢頭。隨著 RECELL 使用報銷政策的明確性恢復，我們的商業部門製定了一項重點計劃，以重新吸引那些減少了 RECELL 使用量的客戶。這是回歸基本執行、有針對性的推廣、嚴謹的後續跟進和強有力的現場問責制，以實現穩定的銷售恢復。

Second, drive consistent utilization of our products. Our sales and commercial teams are working side-by-side to increase case frequency and ensure that our products, RECELL, Cohealyx and PermeaDerm, become part of a routine clinical practice. Consistency and utilization creates internal champions, champions who help expand adoption.

第二，推動我們產品的持續使用。我們的銷售和商業團隊正在並肩工作，以提高病例頻率，並確保我們的產品 RECELL、Cohealyx 和 PermeaDerm 成為常規臨床實踐的一部分。持續性和有效利用能夠培養內部擁護者，而這些擁護者有助於擴大應用範圍。

Third, complete the transition of our commercial organization and enhance forecast accuracy. With the commercial structure now in place, our focus is on ensuring accountability and giving our teams the tools to succeed. We're taking deliberate steps to drive more consistent and predictable revenue growth, grounded in a clear understanding of customer behavior.

第三，完成商業組織的轉型，提高預測準確度。隨著商業架構的建立，我們的重點是確保問責制，並為我們的團隊提供成功的工具。我們正採取審慎措施，以清楚了解客戶行為為基礎，推動更穩定、更可預測的營收成長。

This includes moving towards more organic monthly purchasing patterns and refreshing our forecasting model to provide a more accurate view of future revenue. These priorities are about near-term execution, while serving the longer-term strategic vision that defines who we are and how we win.

這包括轉向更自然的月度購買模式，並更新我們的預測模型，以提供對未來收入更準確的展望。這些優先事項旨在實現近期目標，同時服務於定義我們是誰以及我們如何獲勝的長期策略願景。

Consistent utilization is our foundation. Predictable use of our products drives predictable demand. Portfolio depth is our differentiator. RECELL, Cohealyx, and PermeaDerm, used together, cover the full acute wound healing continuum.

持續高效利用是我們的基礎。我們產品的可預測使用情況帶來了可預測的需求。投資組合的深度是我們的優勢所在。RECELL、Cohealyx 和 PermeaDerm 合併使用，可涵蓋急性傷口癒合的整個過程。

Patient impact remains our purpose. Every decision should ultimately improve outcomes for patients, clinicians and the hospitals that care for them. We've already talked about RECELL, the anchor of our portfolio and our foundation for growth. Let me turn now to our complementary products, Cohealyx and PermeaDerm, both of which extend our reach across the acute wound healing continuum.

造福病人始終是我們的宗旨。每一個決定最終都應該改善病人、臨床醫生和為他們提供醫療服務的醫院的狀況。我們已經討論過 RECELL，它是我們投資組合的核心，也是我們成長的基礎。現在讓我來介紹一下我們的互補產品 Cohealyx 和 PermeaDerm，這兩款產品都擴展了我們在急性傷口癒合領域的應用範圍。

Cohealyx continues to emerge as a complementary growth driver. VAC submissions are underway in roughly 1/3 of our target accounts. As hospitals complete their reviews, we expect ordering to begin and build steadily over the coming quarters. Clinical feedback from our Cohealyx I study remains positive and consistent with our expectations, with surgeons noting rapid readiness for grafting. We expect full enrollment by year-end and anticipate results early next year.

Cohealyx 持續成為一種互補型成長驅動力。我們已經對大約三分之一的目標帳戶進行了VAC提交。隨著醫院完成審查，我們預計訂單將開始，並在接下來的幾個季度中穩步增長。Cohealyx I 研究的臨床回饋依然積極，與我們的預期一致，外科醫生注意到患者能夠迅速做好移植準備。我們預計到年底將完成招生，並預計明年年初將公佈結果。

PermeaDerm also continues to perform well as a versatile biosynthetic dressing that complements both RECELL and Cohealyx across the wound healing continuum. We're encouraged by the early results from our PermeaDerm-I study, and we expect full data next year.

PermeaDerm 作為一種用途廣泛的生物合成敷料，在整個傷口癒合過程中與 RECELL 和 Cohealyx 均有良好的互補作用。我們對 PermeaDerm-I 研究的初步結果感到鼓舞，並期待明年獲得完整數據。

Financial discipline remains a further top priority. As David will explain in more detail, we've taken clear steps to improve the efficiency of our operations. Our operating structure is leaner, our cost base is lower, and our teams are focused on doing more with less, all while maintaining the investments that drive growth. On the balance sheet front, we secured a waiver of our Q3 revenue covenant under our OrbiMed credit agreement and have agreed to an amendment lowering the revenue covenant for Q4.

財務紀律仍然是另一項重中之重。正如大衛將要詳細解釋的那樣，我們已經採取了明確的措施來提高營運效率。我們的營運結構更加精簡，成本基礎更低，我們的團隊專注於用更少的資源做更多的事情，同時保持推動成長的投資。在資產負債表方面，我們根據與 OrbiMed 的信貸協議獲得了第三季收入契約的豁免，並同意修改協議，降低第四季度的收入契約。

Looking ahead, we're maintaining balance sheet flexibility to ensure we have the capital resources to support our operations and growth plans. We'll provide an update on financial outlook, including 2026 revenue and guidance, in early Q1, ensuring that our guidance reflects both operational progress and our capital strategy. In the meantime, we are conserving cash and maintaining disciplined cost control, while continuing to support our operations.

展望未來，我們將保持資產負債表的靈活性，以確保我們擁有足夠的資本資源來支持我們的營運和成長計劃。我們將於第一季初提供財務展望更新，包括 2026 年收入和指引，以確保我們的指引反映營運進度和資本策略。同時，我們正在節約現金，保持嚴格的成本控制，並繼續支持我們的營運。

While Q3 marked a transition for AVITA, it also signals the beginning of a more focused, disciplined and accountable phase for the company. The fundamentals are in place: reimbursement stability; clinical validation; and a first-rate portfolio, RECELL, Cohealyx and PermeaDerm, that allows us to serve every stage of the acute wound care continuum. We are focused on execution, delivering consistent performance, restoring confidence in fulfilling our mission to transform acute wound care for patients, providers and health systems.

第三季標誌著 AVITA 的轉型，同時也標誌著公司進入了一個更專注、自律和負責的階段。基本條件已經具備：穩定的報銷機制；臨床驗證；以及一流的產品組合，RECELL、Cohealyx 和 PermeaDerm，使我們能夠服務於急性傷口護理的各個階段。我們專注於執行，提供持續穩定的業績，重塑人們對我們使命的信心，即改變病人、醫護人員和醫療系統的急性傷口照護。

I look forward to continued engagement with our shareholders and to sharing measurable progress in the quarters ahead.

我期待與股東們繼續保持溝通，並在接下來的幾個季度分享可衡量的進展。

With that, I'll now turn the call over to David.

接下來，我將把電話交給大衛。

Thank you, Cary, and good afternoon, everyone. As Cary described, the third quarter was an inflection point for AVITA, one that reflected the challenges we faced this year, but also the actions now underway to set the stage for improvement. The results were disappointing, but maybe not surprising, given the timing of reimbursement resolution, the pace of hospital VAC reviews and the transition of our commercial organization. With those factors now stabilizing and our cost discipline firmly in place, we entered the fourth quarter better positioned to begin an upward trajectory, measured, deliberate and grounded in execution.

謝謝你，凱瑞，大家下午好。正如凱瑞所描述的那樣，第三季是AVITA的一個轉折點，它反映了我們今年面臨的挑戰，但也反映了目前正在採取的行動，為改進奠定了基礎。結果令人失望，但考慮到報銷解決的時間、醫院 VAC 審查的速度以及我們商業組織的轉型，這可能並不令人意外。隨著這些因素趨於穩定，並且我們的成本控制措施也已到位，我們進入第四季度時，已經做好了更充分的準備，開始穩步、深思熟慮且務實的向上發展。

I'll now walk through our financial results for the third quarter ended September 30, 2025 and provide additional context around our cost structure, liquidity position and financial priorities as we look ahead to the fourth quarter and beyond.

接下來，我將詳細介紹截至 2025 年 9 月 30 日的第三季財務業績，並展望第四季度及以後，提供有關我們的成本結構、流動性狀況和財務重點的更多背景資訊。

Turning to the first slide. It shows a summary of our key financial metrics for the quarter, revenue, gross margin, operating expenses and net loss, which together reflect both the impact on revenue caused by dampened demand due to reimbursement uncertainty, but also shows the benefit of disciplined cost management, which we can control.

翻到第一張投影片。它匯總了我們本季的關鍵財務指標，包括收入、毛利率、營運費用和淨虧損。這些指標共同反映了由於報銷不確定性導致需求下降對收入的影響，同時也反映了我們能夠控制的嚴格成本管理所帶來的好處。

For the third quarter, commercial revenue was $17.1 million compared to $19.5 million in the same period last year, a 13% year-over-year decline. This performance primarily reflected the temporary reimbursement headwinds, along with other factors, including the timing of hospital VAC reviews. However, for the fourth quarter, now that all seven regional MACs have published or confirmed provider reimbursement rates, this peels away a barrier to provider use of RECELL and support the return to growth in RECELL revenue.

第三季商業收入為 1,710 萬美元，去年同期為 1,950 萬美元，年減 13%。這項績效主要反映了暫時的報銷不利因素，以及其他因素，包括醫院 VAC 審查的時間表。然而，到了第四季度，由於所有七個區域 MAC 都已公佈或確認了提供者報銷率，這消除了提供者使用 RECELL 的障礙，並支持 RECELL 收入恢復成長。

As a result of the third-quarter revenue, we are revising our full year 2025 revenue outlook to a range of $70 million to $74 million compared with our prior guidance of $76 million to $81 million. This adjustment reflects the slower-than-anticipated timing of reimbursement normalization, as well as our measured expectations for RECELL demand returning and utilization through year-end.

由於第三季營收情況，我們將 2025 年全年營收預期從先前的 7,600 萬美元至 8,100 萬美元調整為 7,000 萬美元至 7,400 萬美元。這項調整反映了報銷正常化進程比預期要慢，以及我們對 RECELL 需求恢復和年底前使用情況的預期。

Gross profit margin for the quarter was 81.3% compared to 83.7% in Q3 2024. The decline was driven by product mix, consistent with the increasing contribution of Cohealyx and PermeaDerm to overall revenue and other inventory-related adjustments. When isolating the RECELL franchise, gross margin remained strong at 83.6%, which we expect to sustain going forward.

本季毛利率為 81.3%，而 2024 年第三季為 83.7%。下降的原因是產品組合的變化，這與 Cohealyx 和 PermeaDerm 對總收入貢獻的增加以及其他與庫存相關的調整相一致。如果單獨來看 RECELL 系列產品，其毛利率仍維持在 83.6% 的強勁水平，我們預計這一水平將在未來得以維持。

As a reminder, our average sales price share for Cohealyx and PermeaDerm is 50% and 60%, respectively. While these profit-sharing arrangements reduce overall reported gross margin as a percentage, they contribute incremental gross profit. And due to limited additional SG&A expenses associated with this revenue, operating profit is strengthened, along with operating cash flow.

再次提醒，Cohealyx 和 PermeaDerm 的平均銷售價格份額分別為 50% 和 60%。雖然這些利潤分成安排會降低整體報告的毛利率百分比，但它們會增加毛利。由於與此收入相關的額外銷售、一般及行政費用有限，營業利潤和經營現金流均增加。

Total operating expenses were $23 million, down from $30.2 million in Q3 2024, a reduction of $7.2 million or 24% year over year. This improvement reflects the impact of our cost reduction initiatives and the ongoing transformation of our commercial and administrative infrastructure. Breaking that down, sales and marketing expenses decreased by $3.1 million, driven by lower salaries, benefits, stock-based compensation and commissions.

總營運支出為 2,300 萬美元，低於 2024 年第三季的 3,020 萬美元，年減了 720 萬美元，降幅達 24%。這項改進反映了我們降低成本措施的影響以及我們商業和行政基礎設施的持續轉型。具體來說，銷售和行銷費用減少了 310 萬美元，主要原因是工資、福利、股票選擇權和佣金減少。

General and administrative expenses declined by $2.4 million, reflecting reduced headcount and compensation-related costs. Research and development expenses were down $1.7 million, primarily due to lower personnel costs and the capitalization of certain project expenses, specifically in-house developed software.

一般及行政費用減少了 240 萬美元，反映出員工人數減少和薪資相關成本降低。研發費用減少了 170 萬美元，主要原因是人員成本降低以及某些專案費用（特別是內部開發的軟體）的資本化。

As previously disclosed, following the commercial field transformation in Q2, we reduced operating expenses $2.5 million per quarter, or $10 million annually. Actual results for the third quarter show that reduction, which will continue for future quarters.

正如先前所揭露的那樣，繼第二季商業領域轉型之後，我們每季減少了 250 萬美元的營運費用，即每年減少了 1000 萬美元。第三季的實際結果顯示，這一降幅將在未來幾季繼續保持。

Operating loss for the quarter improved by 34% year over year, decreasing to $9.2 million from $13.8 million in the prior year period. Other expense net totaled $2.8 million compared to $1.1 million in Q3 2024. The increase primarily reflects a noncash charge of $2.2 million related to the issuance of 400,000 shares of common stock to OrbiMed as part of the August amendment to our loan facility and a $0.9 million change in the fair value of the debt. These items were partially offset by $0.3 million in investment income.

本季營業虧損年增 34%，從去年同期的 1,380 萬美元降至 920 萬美元。其他支出淨額總計 280 萬美元，而 2024 年第三季為 110 萬美元。此次成長主要反映了與向 OrbiMed 發行 40 萬股普通股相關的 220 萬美元非現金支出（作為 8 月份貸款安排修訂的一部分）以及債務公允價值的 90 萬美元變動。這些支出部分被 30 萬美元的投資收益所抵銷。

Net loss for the quarter was $13.2 million or $0.46 per basic and diluted shares compared to $16.2 million or $0.62 per basic and diluted share in Q3 2024, an improvement of approximately 19% year over year.

本季淨虧損為 1,320 萬美元，即每股基本及攤薄虧損 0.46 美元，而 2024 年第三季淨虧損為 1,620 萬美元，即每股基本及攤薄虧損 0.62 美元，較去年同期改善約 19%。

Turning to our cash position. The next slide shows the quarterly cash waterfall that illustrates our continued progress in managing our cash. We began the quarter with $15.7 million in cash, cash equivalents and marketable securities. In August, we strengthened our balance sheet through a $13.8 million private placement net of expenses. From there, the waterfall chart shows operating cash use totaled $6.2 million in the third quarter, a significant improvement compared with $10.1 million used in Q2, representing nearly a 40% reduction quarter over quarter.

接下來來看看我們的現金狀況。下一張投影片展示了季度現金流瀑布圖，說明了我們在現金管理方面取得的持續進展。本季初，我們擁有現金、現金等價物及有價證券共1570萬美元。8 月份，我們透過扣除費用後的 1,380 萬美元私募配售加強了資產負債表。從瀑布圖可以看出，第三季經營現金使用總額為 620 萬美元，與第二季使用的 1,010 萬美元相比有了顯著改善，環比減少了近 40%。

We ended September with $23.3 million in cash, cash equivalents and marketable securities. This trend reflects the tangible benefits of our cost actions and tighter cash management that we can control, while we return to accelerated revenue growth in future quarters. With our cost structure firmly in place, as revenue grows in 2026, we will methodically move towards cash flow breakeven.

截至9月底，我們持有現金、現金等價物及有價證券共2,330萬美元。這一趨勢反映了我們可控的成本控制措施和更嚴格的現金管理所帶來的實際好處，同時我們也將在未來幾季恢復加速的營收成長。隨著成本結構的穩固，以及2026年營收的成長，我們將有條不紊地朝著現金流收支平衡邁進。

Turning to our debt facility with OrbiMed. As of September 30, we secured a waiver for our third quarter revenue covenant under the OrbiMed facility at no cost. In November, we entered into a sixth amendment to the agreement, which lowered the fourth quarter revenue covenant to $70 million. Further amendment of the 2026 revenue covenant, if necessary, will be addressed once we have established revenue guidance for 2026. We are also evaluating capital funding options to ensure AVITA has sufficient resources to support operations through cash flow breakeven.

接下來，我們將利用與OrbiMed的債務融資機制。截至 9 月 30 日，我們已根據 OrbiMed 協議免費獲得了第三季收入契約的豁免。11 月，我們簽訂了該協議的第六份修訂案，將第四季營收承諾降低至 7,000 萬美元。如有必要，我們將在確定 2026 年收入預期後，對 2026 年收入契約進行進一步修訂。我們也正在評估資本融資方案，以確保 AVITA 擁有足夠的資源來支持運營，直至現金流達到損益兩平。

We expect to provide an update on our capital plans together with 2026 financial guidance in early Q1 of 2026.

我們預計將於 2026 年第一季初發布資本計畫更新以及 2026 年財務指引。

Looking ahead, our financial priorities are clear: first, support revenue recovery as clarity around provider reimbursement stabilizes physician use of RECELL; second, establish a more targeted approach to our large market opportunity to ensure every dollar spent advances putting products into the hands of clinicians and on to patients; third, sustain our disciplined use of cash to support the pathway towards cash flow breakeven.

展望未來，我們的財務重點很明確：首先，隨著醫療服務提供者報銷的明朗化，醫生對RECELL的使用趨於穩定，從而支持收入恢復；其次，針對我們巨大的市場機遇，制定更有針對性的方法，確保每一分錢的投入都能推動產品到達臨床醫生和患者手中；第三，保持我們嚴格的現金使用，以支持實現平衡。

Lastly, with our significantly leaner cost base and stronger visibility into utilization behavior and better forecasting, we are entering a more focused and accountable phase for the company and towards financial sustainability through execution on both growth and efficiency. We remain committed to transparency and execution as we close the year and prepare to share updated financial guidance in early Q1.

最後，憑藉大幅精簡的成本基礎、對利用率行為更清晰的了解以及更準確的預測，我們正在進入一個更專注和負責的階段，公司將透過兼顧成長和效率來實現財務可持續性。我們將繼續秉持透明和高效的原則，為年底的工作做好準備，並計劃在第一季初分享最新的財務指引。

With that, I'll turn back to Cary.

說完這些，我就要轉頭去看凱瑞了。

Thanks, David. To close, while we adjusted our revenue forecast for 2025, the actions we're taking now are setting the stage for a stronger 2026. AVITA has always had the right clinical science, technology and products. What's changing now is how we operate. We've engaged accounts as reimbursement clarity returns, reset our commercial focus and are establishing the structure and accountability needed to deliver consistent performance.

謝謝你，大衛。最後，雖然我們調整了 2025 年的營收預測，但我們現在採取的行動正在為 2026 年的強勁發展奠定基礎。AVITA隨時擁有正確的臨床科學、技術和產品。現在改變的是我們運作方式的改變。隨著報銷政策的明朗化，我們已經與客戶接洽，重新調整了商業重點，並正在建立必要的結構和問責機制，以實現持續穩定的業績。

I'm proud of the team's resilience and focus and confident that we're setting the right conditions for renewed and sustainable growth.

我為團隊的韌性和專注力感到自豪，並相信我們正在為新的、可持續的成長創造正確的條件。

With that, let's open the line for your questions.

那麼，現在開始接受大家的提問。

(Operator Instructions) Ross Osborn, Cantor Fitzgerald.

（操作說明）羅斯·奧斯本，坎托·菲茨杰拉德。

So maybe starting off, can you spend a little bit more time on the initiatives you guys are taking to better be able to forecast the business? Just curious how you're thinking about that as we're getting close to 2026.

首先，您能否多花點時間介紹一下你們為了更好地預測業務而採取的舉措？接近2026年，我很好奇你對此有何看法。

Sure. I mean, good to hear from you, Ross. It gets all the way down to the rep level, to the customer level and understanding how our customers are utilizing the products and then, in turn, how they intend to purchase the products and what kind of cadence that is.

當然。很高興收到你的來信，羅斯。這涉及到銷售代表層面、客戶層面，了解我們的客戶如何使用產品，以及他們打算如何購買產品，以及購買的頻率如何。

And then, we have really good modeling in our sales support structure and really feeling like that's going to even out from month-to-month and quarter to quarter now that we've had a number of months under our belt with some of these newer products and newer customers. And so between the processes and the people that are involved in it and the leadership that is now in place, I think we're going to improve quite a bit.

而且，我們的銷售支援結構模型非常完善，我們感覺隨著幾個月來我們對一些新產品和新客戶的跟進，這種情況會逐漸趨於平衡，每個月和每個季度都會有所改善。因此，憑藉現有的流程、參與其中的人員以及現有的領導層，我認為我們會取得相當大的進展。

Okay. Great. Glad to hear it. And then, nice to see the European approval and realize you're targeting select geographies at this point. But how should we be thinking about your need to balance resources as far as launching in a new market, especially one as fragmented as Europe versus kind of getting the US business back and steady?

好的。偉大的。很高興聽到這個消息。很高興看到你們獲得了歐洲的批准，也意識到你們目前的目標是特定的地區。但是，在開拓新市場（尤其是像歐洲這樣分散的市場）的同時，我們該如何考慮您需要平衡資源，以及如何讓美國業務恢復穩定？

Yes. I mean, our primary focus is the US. We're laser-focused on the US. We're going to be putting in place limited resources, selecting distributors in selected markets, as you said, really trying to understand customers in the market there and getting traction, getting acceptance and clinical champions in those markets. And so while we're committed to them, we understand that our focus and our growth is going to come in the US for a good long time.

是的。我的意思是，我們的主要關注點是美國。我們重點關注美國市場。正如您所說，我們將投入有限的資源，在選定的市場選擇經銷商，真正努力了解當地市場的客戶，並在這些市場中獲得認可、獲得臨床支持者。因此，儘管我們對他們（美國）充滿信心，但我們也明白，在相當長的一段時間內，我們的重點和發展仍將在美國。

We have to get better at what we do in the US. I don't believe we're going to be bifurcated or distracted at all by what we're doing in other countries outside the US. And so, it's not a balance. It's a focus on the US, but with clear intention in these other countries.

我們必須在美國做得更好。我不認為我們會因為在美國以外的其他國家所做的事情而分裂或分心。所以，這不是一種平衡。雖然重點是美國，但對其他國家也有明確的意圖。

Josh Jennings, TD Cowen.

喬什·詹寧斯，TD Cowen。

I was hoping to just -- it's still early days with the normalization of reimbursement and issuing finalized pricing under these new CPT codes. How -- there's probably a wide range of responses from accounts. But how are you guys thinking about the recovery, our accounts, with I guess written policies in place, are going to have confidence in reimbursement going forward?

我原本希望——現在報銷規範化和根據這些新的 CPT 代碼發布最終定價還處於早期階段。如何回答－可能會有各種各樣的答案。但是，你們是如何考慮賠償事宜的呢？我們的帳戶，我想，有了書面政策，以後能否對賠償有信心？

I'm sure some may want to try and make sure they get reimbursement. But should we be thinking that early 2026, we're going to be back to baseline in terms of having a [resal ] customer base have confidence that reimbursement will come through?

我相信有些人可能會想辦法確保獲得賠償。但我們是否應該認為，到 2026 年初，我們的[零售]客戶群將恢復到基線水平，並重新對報銷充滿信心？

Sure. Good to talk to you, Josh. This is about just educating them with the codes and having them start using the product and see that they have that reimbursement and showing and proving to them that it's in place. I think that we've been trying in parallel -- as we've been waiting for the MACs to approve and publish, in parallel, we've been setting up our accounts so that there's not too much time between when they publish and when they feel confident. But yet, there is going to be a bit of a lag.

當然。很高興和你聊天，喬希。這主要是為了向他們普及這些程式碼，讓他們開始使用產品，讓他們看到自己可以獲得報銷，並向他們展示和證明報銷已經到位。我認為我們一直在同步進行——在等待 MAC 批准和發布的同時，我們也同步設定了自己的帳戶，這樣在他們發布和感到有信心之間就不會有太長的時間間隔。但是，還是會有些延遲。

And so, we're in earnest trying to get them up to speed so that not only the physicians, but those that are filing the claims are aware of what they need to do and feel confident about it.

因此，我們正在努力讓他們盡快了解情況，以便不僅醫生，而且提交索賠的人都知道他們需要做什麼，並對此充滿信心。

Josh, this is David. Just to add on one thing on that, and that is, as we talked about, these claims go all the way back to January. And so the MACs are going to adjudicate all of those claims going back to January that are still outstanding. And so, that will also lead to physician confidence when they realize that they're going to get paid for those claims that they've already filed going all the way back to January.

喬希，這位是大衛。關於這一點，我還要補充一點，正如我們之前討論過的，這些說法最早可以追溯到一月份。因此，MAC 將對所有追溯到 1 月仍未決的索賠進行裁決。因此，當醫生意識到他們將獲得自 1 月以來提交的索賠款項時，他們的信心也會增強。

That's helpful. And just any update just on VAC approvals for Cohealyx and how they're trending? And any help just thinking about how many accounts may have the green light for Cohealyx utilization at the start of '26?

那很有幫助。請問Cohealyx的VAC認證進度如何？有什麼最新消息嗎？請問各位能否幫忙估算一下，在 2026 年初，有多少帳戶可能會獲準使用 Cohealyx？

Yes. I mean, we have about one-third of our accounts that have -- that are in the VAC, and about 2/3 of those are scheduled to come out of the VAC in the fourth quarter, but we all know it doesn't always happen on time. So let's say, a fraction of that happens. And then, the idea is how do we truncate the number of days between when it's approved and when they order, and then when they order and when they use it and how much they use it.

是的。我的意思是，我們大約有三分之一的帳戶處於 VAC 狀態，其中大約三分之二的帳戶計劃在第四季度解除 VAC，但我們都知道，這種情況並不總是能按時發生。假設其中一小部分情況發生。然後，我們的想法是，如何縮短從批准到他們下單之間的天數，以及他們下單到使用產品的時間和使用量。

And so our teams in the field are busy preparing for that VAC approval, and so that there are no gaps between that process and the ordering and utilization process.

因此，我們現場的團隊正忙於準備 VAC 審批，以確保流程與訂購和使用流程之間沒有差距。

Understood. Just one more. Just are there accounts where RECELL, Cohealyx and PermeaDerm are all available through VACs if needed? And are you seeing any signals in those accounts around the sales synergies and just the utilization of all three in specific cases has given you guys confidence that this portfolio can ramp once the RECELL reimbursement turbulence is now -- you guys are making your way through the eye of the storm or out of the eye of the storm and VAC approvals are coming for 2026?

明白了。再來一個。是否有帳戶可以透過 VAC（供應商授權）在需要時獲得 RECELL、Cohealyx 和 PermeaDerm 這三種產品？在這些帳戶中，您是否看到任何關於銷售協同效應的訊號？在特定情況下，這三者的運用是否讓您有信心，一旦RECELL報銷的動盪過去，這個產品組合就能迅速成長？ ——你們正在穿越風暴中心，或已經走出風暴中心，VAC批准將於2026年到來？

I'd love to just hear are there any signals from accounts where they have all three products in hand and are utilizing them?

我很想知道，對於那些同時擁有並正在使用這三種產品的帳戶，是否有任何跡象表明他們正在使用這些產品？

Yes. Josh, thanks for the question. This is David again. So as you know, RECELL is already through VAC in the majority of the accounts that we're already serving. There are a few that we still are going through some of the trauma centers.

是的。喬希，謝謝你的提問。這是大衛。如您所知，在我們目前服務的絕大多數帳戶中，RECELL 已經透過 VAC 完成。還有一些病例我們仍在透過一些創傷中心進行處理。

But for the most part, RECELL is already approved. So what we're looking for is those VACs for PermeaDerm and for Cohealyx. And at this point in time, we do have accounts that are approved for all 3 of those, and they are using them on wounds. Now, it's still early days, and we will be able to provide more information on that. I think it's a good KPI at some point to share with all of our investors and our analysts.

但總體而言，RECELL 已經獲得批准。所以，我們正在尋找的是 PermeaDerm 和 Cohealyx 的 VAC 系統。目前，我們已經有帳戶獲準用於這三種用途，並且他們正在將這些帳戶用於傷口治療。現在還處於早期階段，我們將能夠提供更多相關資訊。我認為在某個時候，這是一個值得與我們所有投資者和分析師分享的KPI指標。

But at this point in time, it's a little too early to say what momentum we're getting from those hospitals that have all three approved.

但就目前而言，要說那些三項指標都已獲批准的醫院能為我們帶來多大的動力還為時過早。

Makes sense. We'll wait for some updates on the next earnings call.

有道理。我們將等待下次財報電話會議的最新消息。

(Operator Instructions) Ryan Zimmerman, BTIG.

（操作說明）Ryan Zimmerman，BTIG。

This is Sam on for Ryan. Maybe I can start about how you're thinking about the spending outlook, given where the balance sheet sits today and cash profile. I guess, is there more that needs to be done to right-size the organization going forward? Or are you pleased with how the teams are set up today?

這裡是Sam替Ryan報道。或許我可以先談談您是如何看待支出前景的，考慮到目前的資產負債表狀況和現金狀況。我想，為了讓組織規模更合理，未來是否還需要做更多工作？還是您對目前的團隊配置感到滿意？

Yes, we would -- thanks for the question, Sam. It's David O'Toole. So I had a few comments in my prepared remarks. And we're at a place now where we believe our G&A and our sales team is at a level where we can maintain it. We don't think there are any more additional reductions in expenses that need to happen.

是的，我們會的——謝謝你的提問，山姆。是大衛·奧圖爾。所以我事先準備好的發言稿裡有幾點要補充。我們現在認為，我們的管理費用和銷售團隊都達到了我們可以維持現狀的水平。我們認為無需再進一步削減開支了。

And we're comfortable with -- as shown, that our cash use is declining because of the restructuring that we did in the second quarter, going from $10 million use of cash down to $6 million. We want to continue that trend. But we're not going to do it. We can't cut our way through to profitability. You just can't do that.

正如數據顯示的那樣，由於我們在第二季度進行了重組，我們的現金使用量正在下降，從 1000 萬美元降至 600 萬美元，我們對此感到滿意。我們希望延續這一趨勢。但我們不會這麼做。我們不能透過削減成本來實現獲利。你不能那樣做。

You know that. But what we are at is a place where our expense structure is very disciplined, very solid. And now, it's in a place where we can have that expense structure so that when our revenue increases, it will continue to get us on a path to profitability and cash flow breakeven.

你知道的。但我們現在所處的階段是，我們的支出結構非常嚴謹、非常穩固。現在，我們的支出結構已經到位，這樣當我們的收入增加時，就能繼續帶領我們走上獲利和現金流收支平衡的道路。

Chris Kallos, MST Access.

Chris Kallos，MST Access。

Just staying with the sales team, David or Cary, I know that was a big focus early this year in terms of reconfiguring how those -- that team is being incentivized. Are you thinking about changing the incentive structure for what you have in place or moving towards more of a portfolio sales approach rather than medical detailing?

就銷售團隊而言，無論是 David 還是 Cary，我知道今年年初，重新調整團隊的激勵方式是一個重要的焦點。您是否考慮改變現有的激勵機制，或從醫療產品推廣轉向更注重產品組合銷售的方法？

Well, I've been in the role a few weeks. I'm going to put a lot of sales compensation plans together. I think for us, we're going to want to make sure that it's aligned with what we're trying to accomplish. I think beyond that, as we're in the process of looking at 2026 compensation plans, I do think that it will be simple and fair and directed towards growth. And that's probably all I can tell you right now, but it's definitely going to be aligned with what we're trying to accomplish in the field.

我擔任這個職位已經好幾個星期了。我打算制定很多銷售薪酬方案。我認為對我們來說，我們要確保它與我們想要達成的目標一致。除此之外，我認為，鑑於我們正在研究 2026 年的薪酬方案，我認為該方案將簡單、公平，並著眼於成長。我現在可能只能告訴你這些，但這肯定會與我們在該領域努力實現的目標保持一致。

Yes. I guess that's probably unfair at this stage to ask those questions. Maybe a question for David. With the current guidance such as it is, does that factor in any catch-up from the backlog of reimbursement payments?

是的。我想在這個階段問這些問題可能不太公平。或許可以問大衛一個問題。根據目前的指導方針，是否考慮了補繳積壓的報銷款項？

Chris, good to talk with you, and thanks for the questions. I really appreciate it. Look forward to seeing you down in Australia next week, as always. But from -- this is not going to be a light switch that comes on with the MACs now publishing and having the prices out there. It's going to take a little bit of time.

克里斯，很高興和你聊天，謝謝你的提問。我非常感謝。期待下週在澳洲見到你，一如既往。但是——這不會像蘋果現在發布產品並公佈價格那樣，一蹴而就。這需要一些時間。

We are out there educating our clients, our customers that it has happened and that they will get paid. But it's -- we have to rebuild the confidence of those providers to use RECELL and to know that they're going to get paid. So the guidance for the rest of this year is really a result of the lower revenue from the Q3 and really from the lower revenue from January of this year, caused by the reimbursement headwinds.

我們正在向我們的客戶解釋這件事已經發生，並且他們會得到賠償。但是，我們必須重建這些服務提供者對使用 RECELL 的信心，並讓他們知道他們會得到報酬。因此，今年剩餘時間的業績預期實際上是由於第三季收入下降，以及今年1月因報銷不利因素導致的收入下降所致。

As we said in our prepared remarks, we're going to give a complete update of our revenue guidance for 2026 in early 2026. And so, we'll have a -- everyone will have a better picture of what 2026 looks like at that point.

正如我們在準備好的演講稿中所說，我們將在 2026 年初全面更新 2026 年的營收預期。因此，屆時每個人都會對 2026 年的景像有更清晰的了解。

Great. And David, is it too early to talk about breakeven targets?

偉大的。大衛，現在談論損益平衡目標是不是太早了？

Yes, it is at this point. Cary has been on the job for three or four weeks now. We're all just kind of resetting. And we will be able to give more color around that and all of the revenue guidance for 2026 at the early part of the year.

是的，目前就是這樣。凱瑞已經上崗三到四個星期了。我們都在進行某種程度的調整。我們將在今年年初提供更多相關資訊以及 2026 年的所有收入預期。

And I'm showing no further questions. I would now like to turn the conference back to Cary for closing remarks.

我不會再提其他問題了。現在我謹將會議交還給凱瑞，請他作閉幕致詞。

Thank you, operator, and my thanks to all of you for your questions, your engagement and support. I think we've used the word headwinds quite a bit, both in our remarks and in some of these responses. I think what's interesting about the company is that the very same things that have been headwinds are going to be tailwinds and are going to propel us going forward.

謝謝接線員，也謝謝各位的提問、參與與支持。我認為我們已經多次使用“逆風”這個詞，無論是在我們的發言中還是在一些回應中。我認為這家公司有趣的地方在於，那些曾經是阻礙我們前進的因素，現在都將成為我們的助力，推動我們不斷向前發展。

I think sometimes, the company has issues like recalls and other things that are just stopping them in their tracks. I think in this case, if you take a look at VAC committees that have held us up a bit, those same approvals are going to propel us forward.

我認為有時候，公司會遇到一些問題，例如產品召回和其他一些事情，這些問題會阻礙公司的發展。我認為，在這種情況下，如果你看看那些曾經阻礙我們前進的 VAC 委員會，你會發現，同樣的批准將會推動我們前進。

The same thing occurs with reimbursement uncertainty. When there is certainty, it will propel us forward. The same thing happens with the commercial organization. When you optimize that, that does propel you forward when you get data that tells you that you're saving money and making money by using and purchasing our products. Those types of things propel you forward financially and clinically.

報銷不確定性也會導致同樣的問題。確定性會推動我們前進。商業機構也會遇到同樣的問題。當你優化它時，當你獲得數據告訴你透過使用和購買我們的產品來省錢和賺錢時，它確實會推動你前進。這些事情能幫助你在經濟和臨床上取得進步。

There's really strong evidence that AVITA and our products are going to make a growth move in 2026. And so with that, I look forward to discussing that further progress in the weeks and months ahead with all of you. Thank you.

有確鑿的證據表明，AVITA 和我們的產品將在 2026 年成長。因此，我期待在接下來的幾週和幾個月裡與大家討論這項進展。謝謝。

Thank you. And this concludes today's conference. Thank you for participating. You may now disconnect.

謝謝。今天的會議到此結束。感謝您的參與。您現在可以斷開連線了。