AVITA Medical Inc (RCEL) 2021 Q4 法說會逐字稿

Ladies and gentlemen, thank you for standing and welcome to the AVITA Medical, Inc. Fourth Quarter 2021 Earnings Conference Call. (Operator Instructions)

女士們，先生們，感謝各位嘉賓的蒞臨，歡迎參加AVITA Medical, Inc. 2021年第四季業績電話會議。 （操作員指示）

I would now like to hand the conference over to your speaker for today, Caroline Corner, you may begin.

現在我想將會議交給今天的發言人卡羅琳·科納 (Caroline Corner)，您可以開始。

Thank you, operator. Welcome to AVITA Medical's fiscal fourth quarter and full year 2021 earnings call. Joining me on today's call are Mike Perry, President and Chief Executive Officer; and Michael Holder, Chief Financial Officer.

謝謝接線生。歡迎參加AVITA Medical 2021財年第四季及全年財報電話會議。今天與我一起參加電話會議的還有總裁兼執行長Mike Perry和財務長Michael Holder。

This call will include forward-looking statements within the meaning of the Private Securities Litigation and Reform Act of 1995. All statements made on this call that do not relate to matters of historical fact should be considered forward-looking statements including statements regarding the markets in which AVITA operates, trends and expectations for AVITA's products and technology, trends and demands for AVITA's products, AVITA's expected financial performance, expenses and position in the market, and the impact of COVID-19 on AVITA's operations and AVITA's customers' operations.

本次電話會議將包括《1995 年私人證券訴訟及改革法案》所界定的前瞻性陳述。本次電話會議中所有與歷史事實無關的陳述均應被視為前瞻性陳述，包括關於 AVITA 營運所在市場、AVITA 產品和技術的趨勢和預期、AVITA 產品的趨勢和需求、AVITA 預期的財務業績、費用和市場地位，以及 COVID-19 對 AVITA 營運和 AVITA 客戶營運的影響的陳述。

These statements are neither promises nor guarantees and involve known and unknown risks and uncertainties that could cause actual results, performance or achievements to differ materially from any results, performance or achievements expressed or implied by the forward-looking statements. Please review AVITA's most recent filings with the SEC, particularly the risk factors described in AVITA's S-3 and 10-K filing, and in AVITA's quarterly report on Form 10-Q for the second quarter ended June 30th, 2021 for additional information. Any forward-looking statements provided during this call, including projections for future performance are based on management's expectations as of today. AVITA undertakes no obligation to update these statements except those required by applicable law.

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、績效或成就與前瞻性聲明中表達或暗示的任何結果、績效或成就有重大差異。請參閱 AVITA 向美國證券交易委員會 (SEC) 提交的最新文件，尤其是 AVITA 的 S-3 和 10-K 文件中所述的風險因素，以及 AVITA 截至 2021 年 6 月 30 日的第二季 10-Q 表季度報告中所述的風險因素，以獲取更多資訊。本次電話會議中提供的任何前瞻性聲明，包括對未來業績的預測，均基於管理層截至今天的預期。除適用法律要求外，AVITA 不承擔更新這些聲明的義務。

AVITA's press release for fourth quarter and full year 2021 results is available on AVITA's website, www.avitamedical.com under the Investor Section and includes additional details about AVITA's financial results. AVITA's website also has the latest SEC filings, which you are encouraged to review. A recording of today's call will be available on AVITA's website by 5:00 p.m. Pacific Time today.

AVITA 2021 年第四季及全年業績新聞稿可在 AVITA 網站 www.avitamedical.com 的「投資者」版塊查看，其中包含有關 AVITA 財務業績的更多詳細資訊。 AVITA 網站也提供最新的美國證券交易委員會 (SEC) 文件，建議您查閱。今日電話會議錄音將於太平洋時間今天下午 5 點前在 AVITA 網站上提供。

Now, I would like to turn the call over to Mike for his comments on fourth quarter 2021 business highlights.

現在，我想將電話轉給麥克，請他對 2021 年第四季的業務亮點發表評論。

Thank you, Caroline, and thank you everyone for joining us today. We made strong progress on our growth objectives in the fourth quarter. As you know, from our pre-release in June commercial revenues, not including BARDA-related revenues, were strengthened substantially in the quarter, up 45% quarter over quarter reflecting reopening of parts of the economy which led to a corresponding increase in accidents as well as continued penetration into our burn center accounts as we began to see some improved access to hospitals and increased procedures.

謝謝卡洛琳，也謝謝各位今天與我們共度時光。我們在第四季度的成長目標上取得了顯著進展。正如各位所知，自6月份預發布以來，本季度的商業收入（不包括BARDA相關收入）大幅增長，環比增長45%，這反映了部分經濟領域的重新開放，這導致事故發生率相應增加，同時也反映了我們燒傷中心賬戶的持續滲透，因為我們開始看到醫院就診人數有所改善，手術也有所增加。

While it would be premature to say that the pandemic is behind us, especially given recent developments with the Delta variant, we are encouraged by our recent commercial performance and remain extremely excited about the opportunities ahead with our pipeline indication. Here in AVITA, we are driven by our primary goal of commercializing of proprietary technology to enable healthcare providers to successfully address skin defects, to save lives, and improve quality of life for our patients.

雖然現在斷言疫情已經結束還為時過早，尤其是在德爾塔變異株近期疫情發展的情況下，但我們對近期的商業表現感到鼓舞，並對我們未來在研產品線適應症方面的機會充滿期待。在 AVITA，我們的主要目標是將專有技術商業化，使醫療保健提供者能夠成功治療皮膚缺陷，挽救生命，並改善患者的生活品質。

As we grow from treating burns to trauma to vitiligo to cell and gene therapy and to aesthetics and beyond, our focus is on delivering leading-edge therapeutic skin restoration solutions to our patients. While the company was founded with burn treatments in mind, our team is working to leverage our point-of-care, autologous spray on skin platform across many markets and indications and I'm very pleased to update you today on our latest developments.

隨著我們業務範圍從燒傷治療發展到創傷治療、白斑症治療、細胞和基因治療、美容治療等，我們始終致力於為患者提供尖端的皮膚修復治療解決方案。雖然公司成立之初專注於燒傷治療，但我們的團隊正致力於將我們的即時護理自體皮膚噴霧平台應用於眾多市場和適應症。今天，我很高興向大家介紹我們的最新進展。

With that, I'd like to turn now to our burns business. As a quick update on the product development frontier, at the end of June, we submitted to the FDA a PMA supplement for our new version, the RECELL device with enhanced ease of use. We anticipate FDA approval in the first half of calendar 2022 and commercial launch thereafter.

說到這裡，我想談談我們的燒傷業務。簡單介紹一下產品開發的最新進展。 6月底，我們向FDA提交了一份上市前批准（PMA）補充文件，用於我們新版RECELL設備，該設備操作更加簡便。我們預計該產品將於2022年上半年獲得FDA批准，並隨後投入商業營運。

In our fiscal fourth quarter, we saw COVID abating in many geographies which led to various degrees of economic and social recoveries, which in turn resulted in a corresponding increase in accidents. Our sales team was able to regain some momentum with our customers, which is reflected in our revenue results.

在第四財季，我們看到許多地區新冠疫情有所緩解，經濟和社會也出現了不同程度的復甦，這導致事故數量相應增加。我們的銷售團隊與客戶的關係恢復了一些勢頭，這反映在我們的收入表現上。

I'm very proud to report that our RECELL commercial revenues were a record $6.7 million in the fiscal fourth quarter compared to $4.6 million in the previous quarter ended March 2021. We realized the significant revenue growth primarily from the increase in burn cases but also from our commercial teams through the penetration in burn center accounts.

我很自豪地報告，我們的 RECELL 商業收入在第四財季達到創紀錄的 670 萬美元，而截至 2021 年 3 月的上一季為 460 萬美元。我們實現了顯著的收入成長，主要來自燒傷病例的增加，也來自我們的商業團隊透過滲透燒傷中心帳戶。

Our organization remains well-positioned to respond and quickly pivot to changes in burn-related accidents. We have been building our burn focus sales force for over two-and-a-half years and believe we have the largest and most experienced burns dedicated sales force in the market.

我們的組織始終保持良好的狀態，能夠快速回應燒傷相關事故的變化。我們組成燒傷銷售團隊超過兩年半，堅信我們擁有市場上最大、經驗最豐富的燒傷專業銷售團隊。

In the quarter, we saw increased penetration into accounts and procedures spanning all burn sizes including smaller burns, which has been our focus of late. Approximately 80% of our burn cases come from these smaller wounds or wounds comprising less than 30% TBSA or total body surface area.

本季度，我們觀察到客戶和手術的滲透率有所提升，涵蓋了各種燒傷規模，包括近期重點關注的小面積燒傷。我們約80%的燒傷病例來自這些小面積傷口或占TBSA（即全身表面積）30%以下的傷口。

We ended fiscal 2021 with over 100 hospital accounts with the ABA estimating that there are 136 burn centers in the United States and as we've mentioned previously, we feel that we have established a solid footprint in burn center hospitals. Our focus is now on driving utilization and broadening penetration within this footprint. We believe our recent sales performance illustrates success with implementing this plan.

截至2021財年，我們擁有超過100家醫院客戶，美國燒傷協會（ABA）估計全美共有136家燒傷中心。正如我們之前提到的，我們已在燒傷中心醫院建立了穩固的市場地位。目前，我們的重點是提高利用率並擴大其市場滲透率。我們相信，我們近期的銷售業績證明了該計劃的成功實施。

Revenue from our top 20 accounts increased approximately 25% in fiscal Q4 over fiscal Q3 demonstrating strong growth. If we look back a year ago, our top 20 accounts were contributing 66% of our burn revenue. Today, with a much larger revenue base, our top 20 accounts are delivering just over 40% of revenue reflecting utilization across a broader base of burn centers with over 50% of burn surgeons using RECELL in the quarter and over 80% of the approximately 300 U.S. burn surgeons trained to use the RECELL system, we have indeed established a broad user base. As we look ahead, our sales force will be focusing primarily on driving and expanding usage and adding surgeon users within our existing accounts.

第四財季，我們前20大客戶的營收較第三財季成長了約25%，展現出強勁的成長動能。回顧一年前，前20大客戶貢獻了我們燒傷業務收入的66%。如今，隨著收入基數的擴大，前20大客戶貢獻的收入略高於40%，這反映了更廣泛的燒傷中心的使用情況：本季度超過50%的燒傷外科醫生使用RECELL系統，而全美約300名燒傷外科醫生中超過80%接受了RECELL系統使用培訓，我們確實建立了廣泛的用戶基礎。展望未來，我們的銷售團隊將主要致力於推動和擴大使用量，並增加現有客戶的外科醫師使用者。

As the Delta variant spreads, we are seeing increased access restrictions and we anticipate a potential impact on the availability of burn beds particularly in the south. Of note, data from an ABA sponsored series of surveys between April through August of 2020 showed that of 2,082 burn beds identified in the United States, only 845 beds or 40% were available in April of 2020 and a mere 572 burn beds or 27% were available in August of 2020.

隨著德爾塔變異株的蔓延，我們看到准入限制正在增加，我們預計這可能會對燒傷病床的可用性產生影響，尤其是在南部地區。值得注意的是，美國律師協會（ABA）在2020年4月至8月期間贊助的一系列調查數據顯示，在美國已確認的2082張燒傷病床中，2020年4月僅有845張（佔40%）可用，2020年8月僅有572張（佔27%）可用。

The impact we saw last year during the COVID peak did influence our sales and while we don't currently think the Delta variant will be nearly as disruptive and we are not currently seeing an impact on burn bed availability, we are prepared to pivot and deploy our learnings from the prior waves of COVID.

去年新冠疫情高峰期間我們看到的影響確實影響了我們的銷售，雖然我們目前認為 Delta 變體不會造成那麼大的破壞，而且我們目前也沒有看到對燃燒床可用性的影響，但我們準備調整並部署從前幾波新冠疫情中吸取的經驗教訓。

Moving forward, we continue to leverage our sales forces deep relationships and experience our training capabilities, position engagement programs, and new outreach efforts to educate and engage burn care providers. Today, our sales force is able to access most accounts to support cases and after care and to perform training.

展望未來，我們將繼續利用銷售團隊的深厚關係和經驗，透過培訓、職位參與計劃以及新的外展工作，為燒傷護理人員提供培訓和參與。目前，我們的銷售團隊能夠接觸大多數客戶，提供個案支援、後續護理以及培訓。

During the fourth quarter, we saw substantial traction in small, offsite AVITA events and these live sessions drove physician understanding of incorporation of RECELL into their daily practice and correspondingly our revenue increase.

在第四季度，我們看到小型場外 AVITA 活動取得了顯著的進展，這些會議促使醫生了解將 RECELL 納入他們的日常實踐中，從而相應地增加了我們的收入。

This summer has been slow in terms of professional meetings due to the pandemic status and the impassioned restart of vacations. Yet we expect resumption of regional meetings in the fall. While meetings and conferences are currently planned to in-person, they may change to virtual as a result of the spreading Delta variant.

由於疫情情勢和人們熱情高漲的假期重啟，今年夏天的專業會議數量不多。不過，我們預計秋季區域會議將恢復。雖然目前會議和研討會計劃以線下形式舉行，但由於德爾塔變異病毒的傳播，它們可能會改為線上形式。

Fortunately, enthusiasm from physicians has been very high and we have been successful in the past at adeptly pivoting to virtual meetings. So, we will continue to be flexible as necessary with our participation at meetings and with our physician interactions.

幸運的是，醫生們的熱情一直很高，我們過去也成功地巧妙地轉向了線上會議。因此，我們將繼續根據需要靈活地安排會議參與和與醫生的互動。

With our recent label expansion to treat full-thickness thermal burns in patients one month of age and older, in July, we rolled out a campaign targeting pediatric burn treatment. As you may know, unfortunately, nearly a quarter of all burn cases in the United States occur in children under 16 years of age.

我們近期將藥品標籤擴展至治療一個月及以上患者的全層熱燒傷。今年7月，我們開展了一項針對兒童燒傷治療的活動。您可能知道，不幸的是，美國近四分之一的燒傷病例發生在16歲以下的兒童身上。

One of the main goals within the burn community and hear at AVITA is to avoid painful surgeries, scarring, and multiple grafting procedures. From analysis of our continued access and compassionate use data, RECELL significantly reduced the mean number of pediatric grafting procedures compared to national burn repository data. Our result showed 1.6 grafting procedures using RECELL in combination with grafts versus 3.6 procedures using conventional split-thickness skin graft, which is a very compelling improvement given the pain and scars that patients endure.

燒傷社區和 AVITA 中心的主要目標之一是避免痛苦的手術、疤痕和多次植皮手術。根據我們持續獲取數據和同情用藥數據的分析，與國家燒傷資料庫數據相比，RECELL 顯著減少了兒童植皮手術的平均數量。我們的研究結果顯示，使用 RECELL 合併移植皮膚片的兒童植皮手術平均數量為 1.6 次，而使用傳統分層皮片移植皮膚片的兒童植皮手術平均數量為 3.6 次。考慮到患者所承受的疼痛和疤痕，這是一個非常顯著的改善。

While we do not expect the pediatric label expansion to move the needle significantly on our topline revenue in the near term, we can now engage burn centers that are pediatric only facilities and we are now providing a comprehensive commercial effort that is able to address the vast majority of burn patients.

雖然我們不認為兒科標籤的擴展會在短期內顯著影響我們的營業收入，但我們現在可以與僅限兒科的燒傷中心合作，並且我們正在提供全面的商業努力，以解決絕大多數燒傷患者的問題。

Our commercial team is finding that our new label is reinvigorating conversations. For example, after an extended sales effort, UC Davis, one of the largest U.S. burn centers, recently added RECELL to their formulary driven in part by the new expanded label.

我們的商業團隊發現，新標籤正在重新激發人們對討論的熱情。例如，經過長時間的推廣，美國最大的燒傷治療中心之一加州大學戴維斯分校最近將RECELL添加到其處方集中，這在一定程度上得益於新標籤的擴展。

You may have seen a recent news report in late July in Yonkers, New York of a mother and child being hit by an alleged drunk driver. The child was pinned under a car and was severely burned. I'm very pleased to tell you that RECELL was used successfully to help that child. In seeing these heartbreaking cases, it is truly a privilege to be in a position to make a meaningful difference in the lives of these children and their families.

您可能已經看過七月底在紐約州揚克斯發生的一則新聞報道，一位母親和孩子被一名疑似醉酒司機撞倒。孩子被壓在車下，嚴重燒傷。我很高興地告訴您，RECELL 療法成功地幫助了那個孩子。看到這些令人心碎的案例，我感到非常榮幸，能夠為這些孩子及其家人的生活帶來有意義的改變。

Another area of important impact for us is the subject of injuries not originating from burns. The reopening of the economy and the corresponding increase in accidents meant that in the fourth quarter enrollment in our soft tissue reconstruction trial accelerated. As a reminder, this trial involves non-burn wounds such as those with necrotizing soft tissue infections and degloving injuries which are wounds that commonly present at the same trauma centers where we are currently serving our burn patients.

對我們而言，另一個重要影響領域是非燒傷性損傷。經濟復甦以及隨之而來的事故增加，使得我們軟組織重建試驗的入組人數在第四季加速成長。需要提醒的是，這項試驗涉及非燒傷性傷口，例如伴隨壞死性軟組織感染和脫套傷的傷口，這些傷口通常出現在我們目前為燒傷患者提供服務的創傷中心。

If you recall, we had our first patient in this pivotal trial enroll in March 2020 and we saw slow enrollment for the first year due to the pandemic. We have 17 participating sites with 32 subjects enrolled and treated as of June 30th.

大家還記得嗎？這項關鍵試驗的第一位患者於2020年3月入組，但由於疫情的影響，第一年的入組速度緩慢。截至6月30日，我們共有17個研究中心，入組並治療了32位受試者。

Over the last two quarters, we have seen patient enrollment ticking upwards. For instance, during July, eight additional patients were enrolled. Three patients have been recruited so far in August and our goal is to complete recruitment of all 65 patients by late 2022. With a six-month follow up for patients in this trial, we are aiming for an approval in calendar year 2024.

在過去兩個季度中，我們看到患者入組數量穩定上升。例如，7月新增了8名患者入組。 8月迄今已招募了3名患者，我們的目標是在2022年底前完成所有65名患者的入組。本次試驗將對患者進行為期六個月的隨訪，我們的目標是在2024年獲得批准。

We will be leveraging our existing trauma and burn center sales point and incrementally growing our sales force to address this opportunity. Patients presenting with a requirement for skin grafting and RECELL, whether for burns, trauma or other skin repair, are routinely treated by the same surgeons within an institution. We already know some of our top accounts are using RECELL for trauma as they seek to find the best outcomes for their patients.

我們將利用現有的創傷和燒傷中心銷售點，並逐步擴大銷售隊伍，以抓住這一機會。無論是燒傷、創傷或其他皮膚修復，需要植皮和RECELL治療的患者，通常都會在同一機構內由同一外科醫師進行治療。我們已經了解到，一些頂級客戶正在使用RECELL治療創傷，以期為患者找到最佳治療效果。

As an example, a top surgeon at University Medical Center in New Orleans, which is one of our top 10 accounts, has told us that approximately 10% of their RECELL procedures are currently performed on trauma patients. Based on our internal calculations, we foresee a serviceable addressable market or SAM for trauma and soft injury of $450 million.

例如，新奧爾良大學醫學中心（我們十大客戶之一）的頂級外科醫生告訴我們，目前該中心約10%的RECELL手術是用於創傷患者。根據我們的內部計算，我們預計創傷和軟損傷的潛在市場（SAM）規模將達到4.5億美元。

Moving on now from burns and trauma to our continued progress in vitiligo, for those unfamiliar with the condition, vitiligo is a skin disorder characterized by depigmented areas of skin that appear as white spot or patches and which are primarily attributed to an underlying autoimmune disorder in the patient. There are an estimated 100 million sufferers of vitiligo worldwide including up to 6.5 million Americans.

現在，我們把話題從燒傷和創傷轉移到白斑的治療上，並持續取得進展。對於那些不熟悉白斑症的人來說，白斑症是一種皮膚病，其特徵是皮膚色素脫失區域，呈現為白斑或白斑，主要由患者潛在的自體免疫疾病引起。據估計，全球有1億白斑患者，其中包括多達650萬美國人。

Of those in the U.S., we estimate approximately 1.3 million have stable vitiligo, meaning that their underlying autoimmune disease is being well managed and that their disease is not continuing to spread. We estimate the opportunity for RECELL to re-pigment stable vitiligo patients in the U.S. is at least $5 billion and there is no FDA approved product presently available to enable repigmentation for these patients.

我們估計，在美國，約有130萬白斑症患者處於穩定期，這意味著他們潛在的自體免疫疾病得到了良好的控制，並且病情不會繼續擴散。我們估計，RECELL為美國穩定期白斑症患者恢復色素沉澱的機會至少為50億美元，但目前尚無FDA批准的產品可以幫助這些患者恢復色素沉著。

Recently, FDA approved our proposal for a single-arm vitiligo trial powered with 23 subjects with each site required to complete treatment of a running subject for purposes of training. As a reminder, our original trial was a three-arm trial with 84 patients. While this means we will restart enrollment, we already have 15 centers up and running a robust recruitment program and we continue to expect that enrollment will be completed by the end of calendar 2021 and we continue to plan for approval in 2023.

最近，FDA 批准了我們一項單組白斑症試驗的提案，該試驗納入了 23 名受試者，每個中心都需要完成一名跑步受試者的治療，以用於訓練。需要提醒的是，我們最初的試驗是一個三組試驗，共納入 84 位患者。雖然這意味著我們將重新開始招募，但我們已經有 15 個中心啟動了一項強大的招募計劃，我們預計招募工作將在 2021 年底前完成，併計劃在 2023 年獲得批准。

To further support this opportunity, our products team is developing a new, fully automated version of the RECELL system tailored for the dermatology setting. This is being designed to support our commercial plan for vitiligo and I look forward to updating you as we progress.

為了進一步支持這項機遇，我們的產品團隊正在開發一款專為皮膚科應用量身打造的全新全自動 RECELL 系統。該系統旨在支持我們針對白斑的商業計劃，我期待與您分享進展。

Work advances in our collaborations with the University of Colorado, Gates Center for Regenerative Medicine in epidermolysis bullosa or EB, and with the Houston Methodist Research Institute in rejuvenation. In both cases, we are successfully demonstrating the intended molecular and cellular changes in the laboratory setting and we are now shifting toward demonstrating that these modified cells will form new skin in animal models. These programs both aim to show preliminary proof of concept by the end of this calendar year.

我們與科羅拉多大學蓋茲再生醫學中心在大皰性表皮鬆解症（EB）方面的合作，以及與休士頓衛理公會研究所在皮膚再生方面的合作，正在取得進展。在這兩個項目中，我們都在實驗室環境下成功展示了預期的分子和細胞變化，目前正轉向驗證這些修飾細胞在動物模型中形成新皮膚的能力。這兩個項目都計劃在今年年底前展示初步的概念驗證結果。

I'd now like to walk you through the growth drivers we see ahead. We continue to drive forward on physician engagement and education whether in person or virtual. Notably, our discussions with burn surgeons have largely shifted from whether or not to use RECELL to a focus on optimizing the use of RECELL as well as training and refining the expertise of supporting staff.

現在，我想向大家介紹一下我們預見的未來成長動力。我們將繼續推進醫生的參與和教育，無論是線下或線上。值得注意的是，我們與燒傷外科醫生的討論已從是否使用RECELL轉移到如何優化RECELL的使用，以及培訓和提升支援人員的專業知識。

Our commercial team will be continuing to drive penetration into our burn center accounts. We are VAC approved in what we believe is a critical massive burn centers and with that, we are focused on penetration within those accounts. We have shown that our strategy of driving into smaller burns results in overall broader RECELL usage. And looking ahead, we are leveraging our educational efforts and our expanded label and pediatric campaign to drive more engagement.

我們的商業團隊將繼續推動燒傷中心客戶的滲透。我們已獲得VAC認證，我們認為這些中心是關鍵的大型燒傷中心，因此我們專注於在這些客戶中提升滲透率。事實證明，我們進軍小型燒傷的策略能夠擴大RECELL的使用範圍。展望未來，我們將利用我們的教育工作以及更廣泛的標籤和兒科宣傳活動來提升參與度。

In late July, CMS released the 2022 Medicare outpatient prospective payment system proposed rule which contains a review of RECELL's transitional pass-through or TPT payment application. We anticipate the final rule will be published before calendar year end with payment going into effect in January of 2022. Assuming a successful outcome, a C code will be assigned to RECELL which we anticipate will cover the cost of the device for all Medicare and Medicaid patients.

7月下旬，CMS發布了2022年Medicare門診預付費系統建議規則，其中包含對RECELL過渡性轉付（TPT）支付申請的審查。我們預計最終規則將在年底前發布，並於2022年1月生效。假設成功，RECELL將被分配C代碼，我們預計這將為所有Medicare和Medicaid患者支付該設備的費用。

We would then commence a pilot launch at key sites to ensure coverage with commercial carriers before initiating a broader, nationwide launch likely in mid-2022. Our pipeline initiatives are moving forward, specifically our trauma and vitiligo clinical trials continue to make gains toward completion. We are especially excited about both our new single-arm vitiligo trial as well as our soft tissue trial enrollment, which has 43 of 65 patients enrolled and appears to have benefit from the recent increase in trauma-related accidents.

我們將在關鍵地點進行試點，以確保商業運營商的覆蓋，然後可能在2022年中期啟動更廣泛的全國性推廣。我們的研發項目正在推進，特別是創傷和白斑臨床試驗正在不斷推進，接近完成。我們對新的單組白斑試驗以及軟組織試驗的入組尤其感到興奮，目前已有43例患者入組，共65例，並且似乎受益於近期創傷相關事故的增加。

We continue to be optimistic about our preclinical pipeline work in epidermolysis bullosa and rejuvenation and expect to demonstrate a proof of concept by the end of the calendar year. I look forward to sharing our progress there. Today, we are much more than a burns business.

我們繼續對大皰性表皮鬆解症和年輕化治療領域的臨床前研發管線工作保持樂觀，並預計在今年年底前完成概念驗證。我期待分享我們在這方面的進展。如今，我們已不再侷限於燒傷治療。

Moving to our last growth driver, we anticipate broadening our geographic footprint over the coming years. Together with our commercial partner, COSMOTEC, we continue to seek approval in Japan. As previously reported, we completed the three required, nonclinical bench-top studies in August of 2020 as scheduled. The Japanese health authority has recently undertaken their good clinical practice or GCP audit related to AVITA Medical with no exceptions noted to date.

談到我們最後一個成長動力，我們預計未來幾年將擴大業務覆蓋範圍。我們與商業夥伴 COSMOTEC 攜手，繼續在日本尋求批准。如前所述，我們已於 2020 年 8 月按計劃完成了三項必需的非臨床實驗室研究。日本衛生部門最近對 AVITA Medical 進行了 GCP 審核，迄今未發現任何例外情況。

COSMOTEC will meet with the Japanese reimbursement, MHLW or Ministry of Health, Labor, and Welfare to present RECELL for reimbursement review in the near future. Our efforts in interactions with COSMOTEC and the Japanese regulatory authority are ongoing and we continue to expect approval by calendar year end 2021 of our application for marketing approval of the RECELL system under Japan's Pharmaceuticals and Medical Device Act or PMDA.

COSMOTEC 將在不久的將來與日本報銷主管部門厚生勞動省 (MHLW) 會面，提交 RECELL 進行報銷審核。我們正與 COSMOTEC 和日本監管機構持續溝通，並預計 RECELL 系統根據日本《藥品和醫療器材法》(PMDA) 的上市申請將於 2021 年底前獲得批准。

We are also planning reentry into other U.S. Markets following U.S. approval of new clinical indications for the RECELL system. At that time, we expect to have sufficient economies of scale provided through RECELL indications to provide adequate [ROI] to justify the significant investment required in sales force, infrastructure, training, and reimbursement activities so that we can leverage our existing RECELL CE mark and TGA registration.

我們也計劃在美國批准RECELL系統新的臨床適應症後重新進入其他美國市場。屆時，我們預計RECELL系統將透過新的適應症實現足夠的規模經濟效益，從而提供充足的投資回報率，以證明在銷售團隊、基礎設施、培訓和報銷活動方面所需的大量投資是合理的，這樣我們才能充分利用現有的RECELL CE標誌和TGA註冊。

In summary, we accomplished a lot over this past quarter. Our legacy burns business showed strong growth. We received approvals for expanded burn indication covering pediatrics and extensive burns. We submitted a PMA supplement for a new RECELL device. We made significant strides with our two lead clinical trials and we've made strong progress on our pipeline and product development front.

總而言之，我們在過去一個季度取得了豐碩的成果。我們的傳統燒傷業務實現了強勁成長。我們獲得了擴大燒傷適應症的批准，涵蓋兒科和大面積燒傷。我們為一款新的RECELL設備提交了上市前批准補充文件。我們在兩項主要臨床試驗中取得了重大進展，並且在產品線和產品開發方面也取得了長足的進展。

With that, I'll now turn it over to Michael for details on our financial performance in the quarter. Michael?

現在，我將把話題交給邁克爾，請他詳細介紹我們本季的財務表現。麥可？

Thank you, Mike. In the fourth quarter ended June 30th, 2021, total net revenue increased 166% to $10.3 million compared to $3.9 million in the corresponding period ended June 30th, 2020 and compared to $8.8 million in the prior quarter ended March 31st, 2021.

謝謝你，麥克。截至2021年6月30日的第四季度，總淨收入成長166%，達到1,030萬美元，而2020年6月30日同期為390萬美元，而2021年3月31日上一季為880萬美元。

In the fourth quarter, RECELL commercial revenues increased 72% to $6.7 million compared to the prior quarter. While RECELL revenues associated with Biomedical Advanced Research and Development Authority, BARDA, were $3.6 million, and attributable to the delivery of RECELL units for emergency response preparedness.

第四季度，RECELL 商業收入較上一季成長 72%，達到 670 萬美元。其中，與生物醫學高級研究與發展管理局 (BARDA) 相關的 RECELL 收入為 360 萬美元，這主要歸功於為緊急應變準備而交付的 RECELL 設備。

Gross profit margin was 80% for the fourth quarter of 2021 compared with 77% in the corresponding quarter last year. The increase in our gross profit margin resulted from lower shipping cost and increased production.

2021年第四季毛利率為80%，去年同期為77%。毛利率的提升得益於運輸成本的降低和產量的提升。

Operating expenses were $13.4 million in the fourth quarter of 2021 compared with $16.5 million in the same quarter last year. The decrease in operating expenses is primarily attributable to lower stock based compensation along with higher cost in the prior period associated with the re-domicile transaction partially offset by higher cost in research and development in the fourth quarter.

2021年第四季營運費用為1,340萬美元，去年同期為1,650萬美元。營運費用的減少主要歸因於股票薪酬的減少以及前期遷址交易相關的成本增加，但第四季度研發成本的增加部分抵消了這些影響。

Lower stock-based compensation in the fourth quarter was driven by certain performance milestones being met in the prior year. Higher research and development expenses have resulted from a ramping up of clinical trial related activities related to vitiligo in soft tissue as well as other cost incurred to improve the company's RECELL platform technology and further expand the company's pipeline.

第四季股票薪酬支出減少，原因是去年同期達成了部分業績里程碑。研發支出增加，是由於軟組織白斑症相關臨床試驗活動的增加，以及為改善公司RECELL平台技術和進一步拓展公司產品線而產生的其他成本。

Net loss was $4.7 million for the fourth quarter of 2021 and net loss per share was $0.19 on a weighted average basic and diluted share count of $24.9 million compared to $12.9 million and a net loss per share of $0.60 on a weighted average basic and diluted share count of $21.4 million in the same period of the prior year. Cash was $110.7 million as of June 30, 2021.

2021年第四季淨虧損為470萬美元，每股淨虧損0.19美元，加權平均基本及攤薄股數為2,490萬美元。去年同期淨虧損為1,290萬美元，每股淨虧損為0.60美元，加權平均基本及攤薄股數為2,140萬美元。截至2021年6月30日，現金為1.107億美元。

Moving on to guidance for our first fiscal quarter, we expect total commercial revenue in the first fiscal quarter to be approximately $7 million.

繼續我們對第一財季的預測，我們預計第一財季的商業總收入約為 700 萬美元。

With that, we thank you for your attention. And now, I will turn the call back over to the operator for your questions.

感謝您的關注。現在，我將把電話轉回給接線員，以便回答您的問題。

Thank you. (Operator Instructions). Our first question comes from the line of Josh Jennings with Cowen. Your line is open.

謝謝。 （接線生指示）。我們的第一個問題來自Cowen的Josh Jennings。您的線路已開通。

Hi. Good afternoon. Hi. Good afternoon, Mike and Michael. Thanks for taking the questions and great to see the recovery progress you guys made in the end of quarter, even stronger than the preannouncement.

嗨，下午好。嗨，麥克和邁克爾，下午好。感謝你們回答問題，很高興看到你們在本季末取得了復甦進展，甚至比預告的還要強勁。

I wanted ask about fiscal 2Q guidance -- sorry -- excuse me -- fiscal 1Q guidance (inaudible) the commercial revenue. That's a sequential improvement. It sounds like what you're seeing to date in August and July; you're not seeing disruption from Delta. But I was wondering if you could just help us understand what type of headwinds you are seeing the burn space and then particularly what the trends in August have been like.

我想問第二財季的指引——抱歉——第一財季的指引（聽不清楚）——商業收入。這是一個環比的改善。聽起來就像您在八月和七月迄今為止看到的情況；您沒有看到達美航空帶來的干擾。但我想知道您能否幫助我們了解您在燒錢領域看到了哪些類型的阻力，特別是八月份的趨勢如何。

Thanks for your question, Josh. We are seeing some softening in August. I'm actually -- in addition to Michael and myself, I've got Erin Liberto, our Chief Commercial Officer as well as Andrew Quick, our Chief Technology Officer with me here. So, they'll also e available to answer questions.

謝謝你的提問，喬希。我們在八月看到了一些疲軟。實際上，除了邁克爾和我之外，我們的首席商務官艾琳·利伯托 (Erin Liberto) 和首席技術官安德魯·奎克 (Andrew Quick) 也和我一起在場。所以，他們也會回答我的問題。

And for this one, I'd like to pass it over to Erin to give you a little bit more color on the revenue growth and our estimate of $7 million for commercial revenue in the first quarter.

就這一點而言，我想將其交給 Erin，讓她為您詳細介紹收入成長情況，我們預計第一季商業收入將達到 700 萬美元。

Hi, Josh. How are you? So, I think what we're seeing and what we have anticipated is there's a certain degree of seasonality as you move towards the fall that we're starting to see in the August timeframe and that we're anticipating as we move into September. So, I think that is separate from COVID.

嗨，喬希。你好嗎？所以，我認為我們看到的和我們預期的，隨著秋季的臨近，會出現一定程度的季節性，這種季節性在8月份就開始顯現，我們預計9月份也會出現。所以，我認為這與新冠疫情無關。

Related to the Delta variant, we're certainly seeing that more so in the south. We're seeing that kind of effect, hospitals, the support staff, not as much affecting sales yet. I mean, certain procedures are getting affected but if anything more so delayed than anything else.

與德爾塔變異株相關，我們在南部地區的情況肯定更嚴重。我們看到了類似的影響，包括醫院和支援人員，但對銷售的影響還沒有那麼大。我的意思是，某些流程確實受到了影響，但總的來說，影響比其他任何事情都要大。

But again, I think that we'll have to just wait and see how that might pan out, but I think more so than anything, it's the seasonality that I think that we're anticipating more so.

但是，我再次認為我們必須拭目以待，看看事情會如何發展，但我認為最重要的是，我們更期待的是季節性。

Great. And just one quick follow up on this topic in terms of the burn bed, those metrics you gave from 2020, those are some significant reductions in burn bed availability. But just to be clear, you're not seeing reduction in burn bed availability so far with this Delta surge. Is that -- did I hear that correctly?

太好了。關於燃燒床，我只想快速跟進這個問題。您提到的2020年的指標顯示，燃燒床的可用性顯著下降。但需要明確的是，到目前為止，由於德爾塔激增，燃燒床的可用性並沒有下降。是嗎——我沒聽錯吧？

Yes, that's correct. We're not yet seeing any effect on bed availability and we're hoping that we don't going forward.

是的，沒錯。目前我們還沒有看到床位供應量受到任何影響，希望以後也不會有影響。

Great. One question in the pipeline just on the vitiligo trial design optimization. I was wondering if you could just help share or you could share the signals maybe from a feasibility trial or other data sets that have accrued -- that drove decision to optimize [really] the 1 to 5 or 1 to 10 expansion ratio arms. And did you need to show those signals or those datasets to the FDA to have them accept the trial design modification? And is it your optimism that this is the right way to go from an efficiency standpoint and the commercial standpoint, getting that 1 to 20 expansion ratio indication under your belt?

太好了。關於白癜風試驗設計優化，我有個問題想問。我想知道您是否可以分享一些訊號，例如可行性試驗或其他資料集中累積的信息，這些資訊推動了我們優化1比5或1比10擴增率方案的決定。您是否需要向FDA展示這些訊號或資料集，才能讓他們接受試驗設計的修改？您是否樂觀地認為，從效率和商業角度來看，獲得1比20的擴增率指標是正確的選擇？

So, I'll start off with an answer to that question, Josh, and then pass it over to Andy. Definitely, we are solid in selecting the 1 to 20 expansion going forward in the single-arm trial design with 23 patients that's powered to 90% and we're feeling very comfortable to talk about the datasets that underpin that decision. I will pass it over to Andy.

所以，Josh，我先回答這個問題，然後交給Andy。我們非常堅定地選擇在單組試驗設計中選擇1到20的擴展方案，該方案包含23名患者，其功效達到90%，我們非常樂意討論支持這一決定的數據集。我會把這個問題交給Andy。

Thanks, Mike. Hi, Josh. We have not relied on the feasibility data with respect to our FDA submission, but it's in early days in the feasibility program. In any case, to date, nothing in those data would appear counter to the decision that we have made, which is a strategic decision to sort of consolidate study power into a single arm and there are kind of multiple data points feeding into that.

謝謝，麥克。嗨，喬希。我們提交給FDA的申請並沒有依賴可行性數據，但可行性項目目前仍處於早期階段。無論如何，到目前為止，這些數據似乎沒有違背我們所做的決定。我們的決定是一項策略決策，旨在將研究力量集中到一個單一的試驗組中，並且有多個數據點來支持此決策。

Recent publications are showing results, strong results at the 1 to 20 and higher expansions and our own internal development work on the bench is showing that the food volumes associated with preparation of the 1 to 20 health suspension are optimal for cell harvesting. And so, it's really those data that we use in our FDA submission to consolidate to a single arm.

最近的出版物展示了一些結果，在1比20及更高擴增倍數下取得了強勁成果，而我們內部的實驗室開發工作也表明，製備1比20倍健康懸浮液所需的食物量對於細胞採集來說是最佳的。因此，我們在提交給FDA的申請中，正是使用了這些數據來整合到單一組中。

Thank you. Our next question comes from the line of Matthew O'Brien with Piper Sandler. Your line is open.

謝謝。下一個問題來自派珀·桑德勒的馬修·奧布萊恩。您的線路已開放。

Thanks so much for taking my question. I know there's some softening here in fiscal Q1 as a result of COVID. I get that. But what I'm really interested in is the sequential improvement you saw in fiscal Q4 and I know it's a fourth quarter and a bigger push among the sales force, but that, by my numbers, is about a 40% sequential increase on a per surging basis versus fiscal Q3.

非常感謝您回答我的問題。我知道由於新冠疫情的影響，第一財季的業績放緩。我明白這一點。但我真正感興趣的是您在第四財季看到的環比增長。我知道這是第四季度，銷售團隊的推動力更大，但根據我的數據，與第三財季相比，以人均銷售額計算，季增了約40%。

So, it seems like the strategy of going deeper in these existing accounts is really starting to get traction. So, I'm just wondering as we come out of COVID and some of the impacts you're seeing there, I mean, the ability to drive deeper and deeper penetration seems like it's proving out. So, how quickly can you get back to doing that? And then, again, the revenue per doctor that I'm seeing right now out of fiscal Q4 is about $45,000, roughly. Where do you think that $45,000 can go over time?

所以，深入挖掘現有帳戶的策略似乎真的開始奏效了。所以，我只是想知道，隨著新冠疫情的結束，以及您看到的一些影響，推動日益深入的滲透似乎正在得到證實。那麼，您多久能恢復到這種狀態呢？然後，我再說一次，我目前看到的第四財季每位醫生的收入大約是4.5萬美元。您認為這4.5萬美元隨著時間的推移會變成什麼樣子？

Erin, do you want to take this one with Matt?

艾琳，你想和馬特一起拍這張照片嗎？

Yes. So, I think there were a few things that are happening last quarter that just to put it into perspective. So, first of all, the pendulum somewhat swung, right, when the people are in massive lockdown and all of a sudden, people got their vaccinations and were able to go out and live again. And because of that, the accidents, the pendulum swung from -- because of lockdown, very little accidents to all of a sudden the accidents and the incidents of burn really increased exponentially.

是的。所以，我認為上個季度發生了一些事情，只是為了客觀地看待這個問題。首先，鐘擺在某種程度上發生了變化，對吧？當時人們處於大規模封鎖狀態，突然之間，人們接種了疫苗，可以外出生活了。正因為如此，事故數量也發生了變化——由於封鎖，事故很少，突然之間，事故和燒傷事件真的成倍增加。

So, I would say that our sales was driven by -- in two parts. One part was accidents, an abnormally high accident unlike I've ever seen an increase before and that was due to this desire for people to get out and live again because they've been cooped up.

所以，我想說，我們的銷售成長主要受兩個因素驅動。一方面是事故，事故率異常高，我以前從未見過如此高的成長速度，這是因為人們因為被困在家中，渴望再次外出生活。

Two, it was also driven by the sales team was ready and able to go. They were able to start meet with accounts live. They were able to have live events that are much more impactful than virtual events. We started having offsite training events. We started having just offsite engagement and live engagement that's much more impactful.

其次，銷售團隊的準備也推動了這項進程。他們能夠開始與客戶進行現場會面。他們能夠舉辦比線上活動更有影響力的線下活動。我們開始舉辦線下培訓活動。我們開始將線下活動和線下活動結合起來，效果會好得多。

But you're right. So, we deepened penetration but there was just a lot more cases, burns, actual incidence of burns was much higher. So, it was those two things together.

但你說得對。我們確實深入了研究，但燒傷病例更多了，實際燒傷發生率要高得多。所以，這兩件事是同時發生的。

So, I think the incidence of burns, the pendulum is coming back down, as I mentioned, kind of the seasonality or the incidence of burns is coming back down. We are seeing some tightening of restrictions due to Delta variant coming back into play as well. We are seeing kind of discussions of the fall burns, meetings going back to virtual.

所以，我認為燒傷的發生率，就像我之前提到的那樣，正在逐漸回落，某種程度上是季節性因素，或者說燒傷的發生率正在逐漸下降。由於德爾塔變異病毒的捲土重來，我們看到一些限制措施正在收緊。我們看到關於秋季燒傷的討論，會議也回歸線上。

We are now -- we've got one more live meeting planned but the rest of our live meetings that we have planned for the fall we're putting on pause until we see what happens kind of with the Delta variant. So, there's a few unknown variables that are going to play out here.

我們現在計劃再舉行一次現場會議，但原定於秋季舉行的其他現場會議將暫停，直到我們了解德爾塔變異株的情況。所以，這裡會有一些未知的變數。

But I think you're absolutely right. I mean, we're very successful moving the needle in terms of penetrating with account, but there was a lot more variables to play there. And so, it's a, I think, there's many more dynamics to kind of look at if that helps at all.

但我認為你說得完全正確。我的意思是，我們在帳戶滲透方面取得了很大成功，但這裡面還有很多變數需要考慮。所以，我認為，如果這有幫助的話，還有很多動態因素需要考慮。

Okay. I guess maybe just to put it -- it's very helpful -- just put a finer point on that Erin, I mean, what I'm really curious about is when they're reaching for RECELL versus doing traditional skin graft, I know there seems like the volume was strong here. Is there any way to kind of parse out volume versus just your market share taking where people are saying, you know what, I'm not going do traditional grafting. I'm going to use RECELL instead.

好的。我想或許可以這麼說——這很有幫助——Erin，我想更詳細地解釋一下。我的意思是，我真正好奇的是，當他們選擇 RECELL 而不是傳統的皮膚移植時，我知道這方面的業務量似乎很大。有什麼方法可以分析一下業務量和市場份額，例如人們會說，你知道嗎，我不打算做傳統的皮膚移植，我要用 RECELL。

Yes and that's the tough part about it, right, because we -- the NBR data that we get from the ABA is for the year. We don't get that until a year later. We are starting to track skin grafting data but we get that at a six-month delay, right. So, what we're getting is just kind of ad hoc feedback from the sites on this kind of increase in admissions.

是的，這正是最難的地方，對吧，因為我們——從ABA獲得的NBR數據是當年的數據。我們要到一年後才能拿到。我們開始追蹤皮膚移植的數據，但數據要延遲六個月才能拿到，對吧。所以，我們得到的只是各機構對入院人數增加的臨時回饋。

So, I don't have hard-core data in terms of what those exact number or procedures are for the quarter and what or capture rate was in terms of exact RECELL eligible for you to show what you wanted the market share capture of eligible procedures, right --

因此，我沒有關於本季度確切數量或程序的具體數據，也沒有關於確切 RECELL 合格程序的捕獲率的具體數據，以便您顯示您想要的合格程序的市場份額捕獲率，對嗎 -

Right.

正確的。

-- and that data is challenging.

——而且這些數據很有挑戰性。

Okay, it certainly seems like it's going the right direction though, so thanks for that.

好的，看起來確實朝著正確的方向發展，所以謝謝你。

And then, as a follow up to my two questions, first question, but -- or two-part first question, but on Josh's point on the single-arm vitiligo, I'm just wondering, 90 patients. I know it's by year end, you said that before with the other study design. Going down to a single arm though, can't you crunch the data faster? Isn't the cost of the trial going to be a little bit lower as a result of this? And then, is there any risk that it's not viewed as a more robust clinical study because there's that multi-arm in the eyes of clinicians once you do get the approval?

然後，作為我之前兩個問題的後續，第一個問題，或者說分成兩部分的第一個問題，關於Josh提到的單組白斑研究，我只是想知道90名患者。我知道這個數字是在年底前，你之前在其他研究設計中也提到過。但是，如果只進行單組試驗，難道不能更快處理資料嗎？這樣一來，試驗成本不是會降低一點嗎？然後，如果獲得批准，在臨床醫生眼中，是否存在由於多組試驗的存在而導致其不被視為更穩健的臨床研究的風險？

So, let me again start out with a response here and then pass it over to Andy to add some color to it. But we've got 23 patients that will be enrolled in the pivotal trial. Each site needs to do a run-in patient, as Andy previously mentioned. Basically, it's a practice patient to make sure that they've got the procedure down right.

所以，我先在這裡回覆一下，然後交給安迪補充說明。我們有23名患者將參加這項關鍵試驗。正如安迪之前提到的，每個中心都需要安排一個預備患者。基本上，這名患者是用來練習的，以確保他們正確掌握了整個流程。

And we don't feel that we're losing anything by not studying the 1 to 5 and 1 to 10 concentrations because it's not a linear basically rollout of availability of skin cells relative to diluent when we look at the suspension and that's what Andy's talking about when he speaks about the laboratory results that his group has uncovered in the meantime.

我們不認為不研究 1 比 5 和 1 比 10 的濃度會有什麼損失，因為當我們觀察懸浮液時，皮膚細胞相對於稀釋劑的可用性基本上不是一個線性展開，而這正是安迪在談到他的團隊在此期間發現的實驗室結果時所說的。

So, there's seems to be a greater efficiency as we're at a 1 to 20 with that fluid volume and in the cellular suspension. So, we feel very confident also seeing publications coming out with 1 to 20, 1 to 40, and getting good results with those patients, and I'll pass it over to Andy now if you want to add any color.

所以，當我們以1比20的比例使用這種液體量，並在細胞懸浮液中處理時，效率似乎更高。因此，我們非常有信心看到1比20、1比40比例的論文發表，並在這些患者身上取得了良好的效果。如果您想補充任何細節，我現在就把問題交給安迪。

I mean, you're correct. This trial design is more cost effective for us. And just to put a pin in what Mike is saying, our data don't predict the difference between the 1 to 10, 1 to 5, and 1 to 20. So, that was really what underpinned our decision.

我的意思是，你說得對。這種試驗設計對我們來說更划算。再強調Mike說的，我們的數據無法預測1比10、1比5和1比20的差異。所以，這才是我們做出決定的真正原因。

That answer your question, Matt?

這回答了你的問題嗎，馬特？

That's perfect. Thanks so much.

太好了。非常感謝。

Thank you. Our next question comes from the line of Lyanne Harrison with Bank of America. Your line is open.

謝謝。下一個問題來自美國銀行的Lyanne Harrison。您的電話已接通。

Hi, Mike. Hi, Michael. I'm going to come back to the top 20 accounts. Obviously, it's great to see you [but] a broader base of accounts there with the top 20 now holding 40%. But as I think about rising cases in the United States, can you give us a sense of how many of these top 20 accounts might be in state where we're seeing a significant increase in the Delta variant cases?

嗨，麥克。嗨，邁克爾。我接下來要討論的是前20個帳戶。當然，很高興見到你，[但]那裡的帳戶基礎更廣泛，前20個帳戶現在佔了40%。但是，考慮到美國病例的增加，你能告訴我們，這前20個帳戶中，有多少可能位於我們看到德爾塔變異病例顯著增加的州嗎？

Erin, are you able to answer that?

艾琳，你能回答這個問題嗎？

Yes. Well, I would say that, gosh, a good chunk, I mean, many of our largest accounts are in the top 20, so yes, I mean, I can -- if I look at the numbers, oh gosh, almost half of them are in the top 20 or in the areas that are affected with the Delta in terms of actual proportionately the makeup of the total sales of the top 20 accounts, if that makes sense.

是的。嗯，我想說，天哪，很大一部分，我的意思是，我們很多最大的客戶都排在前20名，所以，是的，我的意思是，如果我看一下這些數字，哦天哪，幾乎有一半的客戶都在前20名，或者位於受三角洲影響的地區，就實際佔前20名客戶總銷售額的比例而言，如果這說得通的話。

Okay. And with those accounts at the moment, as you say with the Delta variant, are you seeing any material change in access to hospitals for those particular accounts?

好的。那麼，就目前的這些帳戶而言，正如您所說的 Delta 變體，您是否看到這些特定帳戶的醫院就診體驗有任何實質變化？

So, there are changes in access but we're still able to get in, right? So, for example, when I say that, there's no what we call plus one. You can't bring anybody with you. You are able to get in to support a case, to do a training, to be there for the after care.

所以，雖然准入條件有所變化，但我們仍然可以進入，對嗎？比如，我剛才說了，沒有所謂的「加一」。你不能帶任何人一起去。你可以進去支持案件，進行培訓，或參與後續護理。

You are now, for some hospitals, required to have -- to be vaccinated. There are kind of more strict requirements to get in, but we are still able to get in.

現在，有些醫院要求必須接種疫苗。雖然入院要求比較嚴格，但我們還是可以入院。

The other issue that is that many of the staff are out with COVID. Many of the nurses are out with COVID. So, we're actually required to be in more often to help support cases or to train. So, if anything, we've seen some cases get delayed because of that, but we haven't, to my knowledge, actually loss a case because of that quite yet.

另一個問題是，許多工作人員因為新冠疫情缺勤。很多護士也因為新冠疫情缺勤。所以，我們其實需要更頻繁地去醫院協助個案處理或進行訓練。所以，如果說有什麼問題的話，那就是我們看到一些病例因此被延誤了，但據我所知，我們還沒有因此損失過任何病例。

Okay. Thank you. And if I could follow up, with the approval for RECELL for pediatric thermal burn, can you give us an indication of what sort of traction you're getting with the pediatric hospitals today?

好的。謝謝。接下來，關於RECELL用於治療兒科熱燒傷的批准，您能否透露一下目前兒科醫院對此的進展如何？

So again, I'll start off and pass it over to Erin. We are getting traction and there is a specific pediatric campaign for pediatric only facilities. A good example is UC Davis where they're one of the top accounts and they've got their major hospital across the street. They've got Shriners Hospital for Children only and they signed on with us partially because of that expanded label with pediatrics. So, that's just an example there. So, we are getting additional traction and I'll pass it on to Erin for any additional color.

所以，我先把話題轉給Erin。我們正在獲得關注，並且有一個專門針對兒科機構的兒科宣傳活動。加州大學戴維斯分校就是一個很好的例子，他們是我們的頂級客戶之一，他們的主力醫院就在街對面。他們有聖地兄弟會兒童醫院，他們與我們簽約的部分原因是因為聖地兄弟會兒童醫院擴大了兒科服務。這只是一個例子。所以，我們正在獲得額外的關注，我會把這個主題轉給Erin，讓她提供更多細節。

Yes. So, there's not a lot of pediatric only burns hospitals in the United States. And so, those that are are the ones that we're now working with to try and get what we call VAC approval or hospital administration approval, and so, many of those hospitals are in that process right now.

是的。所以，美國專門治療兒科燒傷的醫院並不多。我們現在正在與那些專門治療兒科燒傷的醫院合作，爭取所謂的VAC批准，也就是醫院管理部門的批准，目前很多這樣的醫院都在申請這個批准。

Typically, that process can take six months and sometimes longer to kind of get through that. So, we haven't had -- we haven't had our approval for very long. So, we're just kind of getting through that process for the most part with most of those accounts.

通常，這個過程可能需要六個月，有時甚至更長。所以，我們獲得批准的時間並不長。所以，對於大多數帳戶，我們基本上都在經歷這個過程。

But the label certainly been very, very helpful getting approval and also now accessing those conversations and starting the process in those pediatric only accounts. And also, it's been helpful getting access into other accounts just to have new conversations because that also is another excuse to get into hospitals. It's considered a new product or a new news and it is -- it does allow us entry into the hospital to talk about the new data that we have and the new label.

但這個標籤確實非常非常有幫助，它幫助我們獲得批准，現在我們也能存取這些對話，並在兒科專屬帳戶中啟動流程。此外，它還能讓我們存取其他帳戶，進行新的對話，因為這也是我們進入醫院的另一個藉口。它被認為是一個新產品或一個新新聞，它確實讓我們能夠進入醫院，討論我們掌握的新數據和新的標籤。

Thank you. (Operator Instructions). Our next question comes from the line of Ryan Zimmerman with BTIG. Your line is open.

謝謝。 （接線生指示）。下一個問題來自 BTIG 的 Ryan Zimmerman。您的線路已開通。

Hey, thanks for taking the questions. It's great see all the progress. Just ask my two questions upfront and kind of a follow-up to Matt's question. For you Erin, I know we're talking about all the utilization, dynamics and things like that. What are you potentially displacing whether it's skin grafting or other products on some of these cases? I love to understand what you could be also replacing beyond skin grafting.

嘿，謝謝你回答這些問題。看到這麼多進展真是太好了。我先問兩個問題，也算是對馬特問題的後續跟進。至於你，艾琳，我知道我們正在討論所有利用率、動態等等。對於某些病例，你可能會用皮膚移植或其他產品來取代哪些東西？我很想知道除了皮膚移植之外，你還能用什麼來替代。

And then the second question, and Mike, I know you don't want to prognosticate on pass-through status. But if you read the comments with the FDA, there's a discussion around whether RECELL itself is device and how they're thinking about it? And so, I love just your latest thoughts on what you think or what you're interactions with the agency or CMS has been around this and kind of where you're head's at in terms of getting that pass-through label? Thanks for taking the questions.

然後是第二個問題，麥克，我知道你不想對「傳遞」狀態做出預測。但如果你讀過FDA的評論，你會發現他們正在討論RECELL本身是否屬於醫療器械，以及他們對此有何看法。所以，我很想聽聽你最近的想法，談談你與FDA或CMS在這方面的互動，以及你在獲得「傳遞」標籤方面的想法。謝謝你回答這些問題。

Sure, Ryan. Why don't I let Erin answer the first question about what are we displacing beyond skin grafts. I'll the second one on our pass-through payment.

當然，Ryan。第一個問題，除了皮膚移植，我們還要轉移什麼？第二個問題，我會回答關於我們的轉付款項。

So, just to be clear, our target is skin grafting. Skin grafting is the standard of care. Skin grafting is where the volume's at. The only other product -- Epicel is the only other product in the market and the volumes with Epicel are so low. Their price point is very, very high. But when you actually look at what that equates to in terms of procedural volume, it is very, very low and that's not meaningful for us in terms of volume. So, that's not our target.

所以，要先明確的是，我們的目標是植皮。植皮是標準的治療方法，植皮是植皮量最大的領域。市面上唯一的其他產品——Epicel，也是唯一的其他產品，而且Epicel的量非常低。他們的價格非常非常高。但如果你真正考慮到植皮在手術量方面所佔的比例，你會發現它非常非常低，這對我們來說沒有太大的意義。所以，這不是我們的目標。

Our target is skin graft. And any time that you may require a skin graft, consider RECELL. And essentially, TBSA or total body surface areas of 5% and higher is pretty much our sweet spot anytime you could require skin graft.

我們的目標是植皮。任何時候，如果您需要植皮，都可以考慮RECELL。基本上，TBSA（即全身表面積）達到或超過5%的植皮面積，對於可能需要植皮的人來說，都是我們的最佳選擇。

So, it's really it's changing the standard of care. It's a total paradigm shift. That's what we're focusing on.

所以，這其實改變了醫療標準。這是一場徹底的典範轉移。這正是我們關注的重點。

And I'll just follow upon the pass-through payment for our outpatients. And you are correct that CMS in the federal register said that we basically check all the boxes but they're uncertain that we are or should be classified as a device.

我接下來想跟進我們門診病人的轉付狀況。你說得對，CMS在《聯邦公報》上說我們基本上符合所有條件，但他們不確定我們是否應該被歸類為醫療設備。

Of course, we do have a PMA approved, which is a device. We do have device breakthrough designation and the FDA has fully regulated us as a device. And there's also a change of staff that has gone on at CMS and what I believe is that it's really a re-education program or process that we need to go through with the change of staff to get them up to speed and have them really understand the details of what's been going on.

當然，我們確實獲得了上市前許可 (PMA) 的批准，這是一種設備。我們確實獲得了突破性設備認證，FDA 也對我們進行了全面的設備監管。 CMS 的員工也發生了變動，我認為這實際上是一個再教育項目或流程，我們需要對員工進行調整，讓他們快速上手，真正理解正在發生的事情的細節。

And of course, during the open comment period, CMS is not going to provide any additional commentary on it. But we remain confident that this will come through with that being their only question. Erin, I don't know if the reimbursement group works for you, but anything to add?

當然，在公開評論期間，CMS 不會對此發表任何額外的評論。但我們仍然相信，這將會得到解決，因為這是他們唯一的問題。 Erin，我不知道報銷小組是否適合您，有什麼要補充的嗎？

No, I think you've covered it. I mean, hopefully, we'll -- typically, they will publish the final rule in November last year. It was a little bit later in December. But hopefully, we'll know by year end. I think we're more optimistic still. I think we were surprised on that feedback given everything that you said, but we'll have to wait and see.

不，我想你已經講過了。我的意思是，希望我們——通常他們會在去年11月發布最終規則。後來是在12月稍晚。但希望我們能在年底前知道結果。我認為我們仍然比較樂觀。考慮到你所說的一切，我想我們對這個回饋感到驚訝，但我們還得拭目以待。

Thank you. Our next question comes from the line of John Hester with Bell Potter. Your line is open.

謝謝。下一個問題來自貝爾·波特的約翰·赫斯特。您的線路已開放。

Good afternoon, everyone. Thank you for your time today. Michael, if you could just expand on your comments about the Japan markets that's [looming], fairly cognizant actually, you said like 21 your expected approval is, presumably for the launch in calendar year '22? Can you just run through the key points on your commercial arrangements there with COSMOTEC please?

大家下午好。感謝您今天的寶貴時間。 Michael，您能否進一步談談您對即將進入的日本市場的看法？您之前說過，預計21年獲得批准，大概會在22年推出。能否簡單介紹一下您與COSMOTEC在日本的商業安排的要點？

Sure (multiple speakers) --

當然（多位發言者）—

And some -- maybe some volume comments, sorry.

還有一些——也許有一些音量評論，抱歉。

Sure. Why don't I start off and then I may pass it to Michael Holder for some additional color commentary if he has any.

當然。不如我先開始，然後我再把它交給邁克爾·霍爾德，讓他補充一些精彩的評論。

But our arrangement with COSMOTEC, our partner in Japan, is that it's approximately a 50% revenue share. And you've heard of the progress. There's a GCP audit that has began, no findings to date. There's also some planned discussions with the Ministry of Health, Labor, and Welfare on reimbursement which are all very positive commentary relative to the approval coming up at calendar year end which we've not changed our guidance on and we still do anticipate that, and we do anticipate a launch in 2022.

但我們與日本合作夥伴COSMOTEC的協議是，雙方各佔約50%的收入份額。你們也聽說了進展。 GCP審核已經開始，目前尚無發現。此外，我們還計劃與厚生勞動省就報銷事宜進行一些討論，這些討論都對年底即將獲得的批准給予了非常積極的評價，我們對此沒有改變預期，並且仍然期待該藥物在2022年上市。

And so far as the volumes and how much we'll sell or COSMOTEC will sell, rather, it's hard to say until we actually get the label from PMDA because COSMOTEC with us in collaboration we have applied for very broad label to include burns and we're confident of getting the indication of burns.

至於數量以及我們或 COSMOTEC 的銷售量，在我們真正獲得 PMDA 的標籤之前很難說，因為 COSMOTEC 與我們合作申請了非常廣泛的標籤，包括燒傷，我們有信心獲得燒傷的適應症。

But it also includes soft tissue. It includes vitiligo. It also includes potentially chronics. So dependent upon what indications are actually approved by the PMDA and given reimbursement by the MHLW that will determine the volumes and then the revenue that's going to be coming to us. That answer your question, John? But (multiple speakers) --

但它也包括軟組織疾病，包括白斑症，也包括潛在的慢性疾病。所以，這取決於哪些適應症最終獲得PMDA的批准，以及厚生勞動省的報銷，這將決定我們的治療量和最終收入。這回答了你的問題，約翰？但是（多位發言者）－

Thank you. Just as a follow up -- just as a follow up, Mike.

謝謝。只是跟進一下——只是跟進一下，邁克。

Sure.

當然。

What do you believe is the market in the Japan for vitiligo in terms of how many stable patients? Is it 1.3 million in the U.S.? How many -- any idea what that could be in Japan?

您認為日本的白斑市場規模大概是多少？美國有130萬穩定期患者嗎？日本大概有多少？

Generally, it's 10% is rule of thumb, but let me pass it over to Erin to give you more detail that she may have.

一般來說，10% 是經驗法則，但讓我把它交給 Erin，以便她能為你提供更多細節。

Yes. So, China and Japan have a little bit or China, Japan, and the U.S. are kind of the highest nations for vitiligo. There's about 2 million patients that suffer from vitiligo. So, if you use the same proportions that we have in the U.S. for stable, that's just over half a million that are -- have stable vitiligo.

是的。中國和日本的白斑症發生率略高，或者說，中國、日本和美國是白斑症發病率最高的國家。約有200萬白斑症患者。所以，如果以美國穩定期白斑症的比例計算，那麼穩定期白斑症患者人數略高於50萬人。

Okay. And Mike, just finally, you also talked about other geographic expansions. Anything that's happening beyond Japan at this point?

好的。麥克，最後，你還談到了其他地區的擴張。目前日本以外還有進展嗎？

At this point, no. We're really waiting for additional indication approvals. And once -- to be more specific, once we got soft tissue and vitiligo approved in the United States, then we will have the necessary ROI that we need to go into each country in Europe and get a sales force going, negotiate reimbursements, do our economic models, and really get into Europe as well as back into Australia.

目前還沒有。我們確實在等待更多適應症的批准。更確切地說，一旦我們在美國獲得軟組織和白斑治療的批准，我們就能獲得必要的投資回報，從而進入歐洲各國，建立銷售團隊，協商報銷，建立經濟模型，最終真正打入歐洲市場以及澳大利亞市場。

Thank you. I'm not showing any further questions in the queue. Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect.

謝謝。隊列中沒有其他問題。女士們，先生們，今天的電話會議到此結束。感謝您的參與。現在您可以掛斷電話了。