AVITA Medical Inc (RCEL) 2022 Q1 法說會逐字稿

Good day and thank you for standing by. Welcome to the AVITA Medical's First Quarter 2022 Earnings Conference. At this time, all participants are in a listen-only mode. After the speakers' presentation, there will be a question-and-answer session.

大家好，感謝您的參與。歡迎參加 AVITA Medical 2022 年第一季業績發表會。目前，所有與會者均處於聆聽模式。演講嘉賓演講結束後，將進行問答環節。

(Operator Instructions). Please be advised that today's conference is being recorded. (Operator Instructions).

（操作員指示）。請注意，今天的會議正在錄音。 （操作員指示）。

I would now like to hand the conference over to your speaker today, Caroline Corner, with Investor Relations. Please go ahead.

現在，我想將會議移交給今天的發言人，投資者關係部的Caroline Corner。請開始。

Thank you, operator. Welcome to AVITA Medical Fiscal First Quarter 2022 Earnings Call. Joining me on today's call are Mike Perry, Chief Executive Officer and Michael Holder, Chief Financial Officer.

謝謝接線生。歡迎參加AVITA Medical 2022財年第一季財報電話會議。今天與我一起參加電話會議的還有執行長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 Medical operates, trends, demands and expectations for its products and technology, its expected financial performance, expenses and position in the market and the impact of COVID-19 on its operations and its customer's operations.

本次電話會議將包括《1995 年私人證券訴訟和改革法案》所定義範圍內的前瞻性陳述。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 Medical 運營的市場、其產品和技術的趨勢、需求和期望、其預期的財務業績、費用和市場地位以及 COVID-19 對其運營和客戶運營的影響的陳述。

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 Medical most recent filings with the SEC, particularly the risk factors described in AVITA Medical's S-3 and 10-K filing, and in AVITA Medical's quarterly report on Form 10-Q for the first quarter ended September 30, 2021 for additional information.

這些聲明並非承諾或保證，且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明示或暗示的任何結果、績效或成就有重大差異。更多信息，請參閱 AVITA Medical 向美國證券交易委員會 (SEC) 提交的最新文件，尤其是 AVITA Medical 的 S-3 和 10-K 文件中所述的風險因素，以及 AVITA Medical 截至 2021 年 9 月 30 日的第一季度 10-Q 表季度報告中所述的風險因素。

Any forward-looking statements provided during this call, including projections for future performance are based on management's expectations as of today. AVITA Medical undertakes no obligation to update these statements except those required by applicable law.

本次電話會議中提供的任何前瞻性陳述，包括對未來業績的預測，均基於管理層截至今日的預期。除適用法律要求外，AVITA Medical 不承擔更新這些陳述的義務。

AVITA Medical's press release for the first quarter results is available on its website, www.avitamedical.com under the Investor Section and includes additional details about its financial results. AVITA Medical'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 Medical's website by 5:00 p.m. Pacific Time today.

AVITA Medical 的第一季業績新聞稿可在其網站 www.avitamedical.com 的「投資者」版塊查閱，其中包含更多財務業績詳情。 AVITA Medical 網站上也提供了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 Medical 網站上發布。

Now, I'd like to turn the call over to Mike for his comments on first quarter 2022 business highlights.

現在，我想將電話轉給麥克，請他評論一下 2022 年第一季的業務亮點。

Thank you, Caroline and thank you everyone for joining us today. We are encouraged by our recent commercial performance and remained extremely excited about the opportunities ahead with our pipeline indications. Here at AVITA medical, we are driven by our primary goal of commercializing our proprietary technology to enable healthcare providers to successfully address skin defects, to save lives and improve quality of life for our patients.

謝謝Caroline，也謝謝各位今天的到來。我們對近期的商業表現感到鼓舞，並對我們未來產品線的潛力充滿期待。 AVITA醫療的首要目標是將我們的專有技術商業化，幫助醫療保健提供者成功解決皮膚缺陷問題，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 burns treatment in mind, our team is working to leverage our point of care autologous spray-on skin platform across many markets and indications, and I am 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 to our burns business. I'm pleased to report that our commercial revenues were $6.9 million in the first fiscal quarter compared to $6.7 million in the previous quarter ended June 2021. Last Tuesday, the Centers for Medical and Medicaid Services or CMS approved AVITA Medical's application for a Transitional Pass-Through Payment device category C code that will provide separate payment for RECELL used in procedures that are performed in hospital outpatient facilities and in ambulatory surgical centers.

接下來，我想談談我們的燒傷業務。我很高興地報告，我們第一財季的商業收入為690萬美元，而截至2021年6月的上一季為670萬美元。上週二，美國醫療和醫療補助服務中心（CMS）批准了AVITA Medical的過渡性轉付支付設備C類代碼申請，該代碼將為在醫院門診和門診手術中心進行的RECELL手術提供單獨的付款。

The TPT device category which is intended to facilitate the adoption of new technology for Medicare beneficiaries by offsetting the cost of the device to facilities will be effective January 1st 2022. This new code expands RECELL burn treatment to a new care setting with existing customers and lays a reimbursement foundation for our soft tissue repair indication that we are working towards.

TPT 設備類別旨在透過抵銷設備設施成本來促進醫療保險受益人採用新技術，該類別將於 2022 年 1 月 1 日生效。這項新代碼將 RECELL 燒傷治療擴展到現有客戶的新護理環境，並為我們正在努力實現的軟組織修復適應症奠定了報銷基礎。

As a quick update on the product development front, at the end of June we submitted to the FDA a PMA supplement application for our new version of the RECELL device with improved ease of use which we hope will allows us to approach our future markets more readily. We anticipate FDA approval in the first half of calendar 2022 and a commercial launch thereafter.

關於產品開發的最新進展，我們在6月底向FDA提交了一份上市前批准（PMA）補充申請，用於改進了RECELL設備的易用性，希望這能讓我們更輕鬆地進入未來市場。我們預計將於2022年上半年獲得FDA批准，並隨後進行商業化上市。

The improved ease of use device will allow AVITA Medical to better address our burn outpatient market facilitated by the new TPT code issuance as well as our soft tissue repair indication once approved. More specifically, the ease of use device allows for improved surgeon and staff handling by only requiring one set of hands in the sterile field as well as a reduction in device handling steps by one-third.

改進後的易用性設備將使 AVITA Medical 能夠更好地應對新 TPT 代碼發布的燒傷門診市場，以及一旦批准後軟組織修復適應症的市場需求。更具體地說，該易用設備只需在無菌區域內用一隻手操作，從而改善了外科醫生和工作人員的操作，並將設備操作步驟減少了三分之一。

We've been building our burns focused sales force for three years and believe we have the largest and most experienced burns dedicated sales force in the market. However, at this time due to largely to COVID, our sales force is selling into a system which is experiencing staffing shortages. Our surgeons rely heavily on their experience nursing staff and high turnover in early retirements are impacting result procedures.

三年來，我們一直在打造專注於燒傷治療的銷售團隊，並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。然而，目前主要由於新冠疫情的影響，我們的銷售團隊正在向一個人員短缺的醫療體系銷售產品。我們的外科醫師嚴重依賴經驗豐富的護理人員，而提早退休的高流動率正在影響手術的療效。

In response to the situation, we have prioritized our training and education efforts and hope to see improvement in procedure rate as the pandemic continues to abate. Our commercial focus is on driving utilization and broadening penetration within our footprint of over 100 hospitals and over 250 trained physicians. Revenue from our top 20 accounts increased approximately 7.7% in fiscal Q1 over fiscal Q4, driven by growth in the top five accounts which saw 18.3% growth.

為應對當前情勢，我們已將培訓和教育工作列為優先事項，並希望隨著疫情持續緩解，手術率能夠提高。我們的商業重點是提高利用率，並擴大我們涵蓋100多家醫院和250多名訓練有素的醫生的覆蓋範圍。第一財季，我們前20大客戶的營收較第四財季成長了約7.7%，這得益於前五名客戶18.3%的成長。

Our top five account had been less impacted by the staffing shortages being larger and with dedicated burn staff which has enabled our growth here. It's clear that nursing training has a tremendous impact on hospital's ability to perform procedures and the nursing staff therefore has a substantial influence on the use of RECELL. While we are continuing to train physicians, we are approaching our training efforts with a strong focus on advanced practice providers.

我們的五大客戶受人員短缺影響較小，因為這些客戶擁有專業的燒傷護理團隊，這促進了我們在這方面的成長。顯然，護理訓練對醫院的手術執行能力有著巨大的影響，因此護理人員對RECELL的使用也有很大的影響。雖然我們仍在繼續培訓醫生，但我們的培訓重點將放在高級執業醫師身上。

Training includes local, regional and national events for both surgeons and their staff. In addition in the last quarter, we had held almost 550 hands on trainings in the field and we are currently performing approximately 200 in hospital training sessions per month. Last weekend, we presented 10 abstract at the ABA Southern Region Burn Conference, the largest ABA region and the largest U.S. burn conference next to the Annual ABA Meeting in the spring.

培訓包括針對外科醫生及其工作人員的本地、區域和全國性活動。此外，在上個季度，我們已舉辦了近550場現場實務培訓，目前我們每月在醫院進行約200場培訓。上週末，我們在ABA南部地區燒傷會議上發表了10篇論文摘要，這是ABA地區規模最大的燒傷會議，也是僅次於春季ABA年會的美國規模最大的燒傷會議。

The presentations covered topics such as small burns, pediatric burns and topics of integration of RECELL into practice such as synergistic combinations with RECELL and health economics. Additional, later this week we will have two RECELL presentations at the Northeast Region Burn Conference. Interest in RECELL remains high and despite the pressure on procedure rates, we are completing cases and delivering on our mission to save and improve patients' lives.

報告涵蓋了小面積燒傷、兒童燒傷以及將RECELL技術融入實踐（例如與RECELL技術的協同作用以及衛生經濟學）等主題。此外，本週晚些時候，我們將在東北地區燒傷會議上舉辦兩場RECELL技術報告。人們對RECELL技術的興趣仍然高漲，儘管手術率面臨壓力，但我們仍在完成病例，以履行拯救病患生命、改善病患生活的使命。

In the first quarter during Hurricane Ida, a family suffered severe burns with their gas grill they were using due to power outages exploded. The pregnant mother, her husband and their toddler were all burned. The family was taken to University Medical Center in New Orleans where they were treated by three different surgeons. All were successfully treated with RECELL. Today, I'm very pleased to tell you that all family members are recovering and the mother who suffered burns to her leg is able to climb the stairs to her third floor home and to carry her toddler.

颶風「艾達」來襲的第一季，一家人因停電導致瓦斯烤肉爐爆炸，造成嚴重燒傷。這位孕婦、她的丈夫和蹣跚學步的幼兒均被燒傷。一家人被送往新奧爾良大學醫學中心，在那裡接受了三位外科醫生的治療。所有患者均成功接受了RECELL療法的治療。今天，我很高興地告訴大家，所有家庭成員都已康復，腿部燒傷的母親現在能夠爬樓梯回到她家的三樓，並抱著她的孩子。

While our commercial focus to date has been in burns, another area of important impact for us is injuries not originating from burns. The reopening of the economy and the corresponding increase in accidents meant that in our fiscal fourth quarter and first quarter, enrollment in our soft tissue reconstruction trial materially accelerated.

雖然我們迄今為止的商業重點是燒傷，但另一個對我們產生重要影響的領域是非燒傷造成的傷害。經濟的重新開放以及隨之而來的事故增加，意味著在第四財季和第一季度，我們軟組織重建試驗的入組人數顯著增加。

This trial involved injury such as the resection of necrotizing soft tissue infections and degloving injuries which are wounds that commonly present at the same trauma centers where we're currently treating our burn patients. If you recall, we had our first patient in this pivotal trial enrolled in March 2020 and we saw slow enrollment for the first year due to the pandemic.

這項試驗涉及的損傷包括壞死性軟組織感染和脫套傷的切除，這些傷口通常出現在我們目前治療燒傷患者的創傷中心。如果您還記得的話，這項關鍵試驗的第一位患者入組於2020年3月，由於疫情的影響，第一年的入組速度較慢。

Today, we have 19 of the 20 planned sites up and enrolling with 58 of 65 subjects enrolled to date. In October alone, we enrolled 10 new subjects expanding broad geographies. Since the closed of the June quarter, a resounding 40% of the required 65 subjects had been enrolled. Assuming current trends continue and allowing for the typical slowdown in clinical research during the holiday season, we now plan to complete recruitment by Q1 of 2022 well ahead of our last update.

目前，我們計劃在20個試驗點中，已有19個啟動並開始招募受試者，目前已招募了65名受試者中的58名。光是在10月份，我們就招募了10位新受試者，拓展了廣泛的地域範圍。自第二季結束以來，我們已招募了所需65名受試者中的40%。假設目前的趨勢持續下去，並考慮到假期期間臨床研究的放緩，我們目前計劃在2022年第一季完成招募，這將比上次更新的時間提前很多。

With the six-month follow-up for patients in this trial, we're aiming for an approval by the end of 2023. As a reminder based on our internal calculations, we foresee a serviceable addressable market or SAM for trauma and soft tissue injury of $450 million. 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.

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2023年底前獲得批准。需要提醒的是，根據我們的內部計算，我們預計創傷和軟組織損傷的潛在市場（SAM）將達到4.5億美元。無論是燒傷、創傷或其他皮膚修復，需要植皮和RECELL治療的患者通常由同一機構的同一位外科醫生進行治療。

We plan to address this market through our existing hospital account and with the addition of 220 level one and level two trauma centers. After we have U.S. FDA approval, we plan to quickly leverage our existing trauma and burn center sales relationships to launch into trauma and acute wounds, and we will incrementally expand our sales force to address this opportunity.

我們計劃透過現有的醫院客戶以及新增的220家一級和二級創傷中心來拓展這一市場。在獲得美國FDA批准後，我們計劃迅速利用現有的創傷和燒傷中心銷售關係，進軍創傷和急性傷口領域，並將逐步擴大銷售隊伍，以抓住這一機會。

Moving on now from burns and trauma to our continue progress in vitiligo. For those unfamiliar with the condition, vitiligo is a skin disorder characterized by deep pigmented areas of skin that appear as white spots or patches and which are primarily attributed to an underlying autoimmune disorder in the patient.

現在，我們把話題從燒傷和創傷轉移到白斑的持續進展。對於不熟悉白斑症的人來說，白斑症是一種皮膚病，其特徵是皮膚色素沉澱區域出現白斑或白斑，主要由患者潛在的自體免疫疾病引起。

There are an estimated 100 million sufferers of vitiligo worldwide including up to 6.5 million Americans. Of those in the U.S., we estimate approximately 1.3 million have stable vitiligo, our target population, meaning that their underlying autoimmune disease is being well-managed and that their disease is not continuing to spread.

據估計，全球有1億白斑患者，其中包括多達650萬美國人。在美國，我們估計約有130萬人的白斑症情穩定，這是我們的目標族群，這意味著他們的潛在自體免疫疾病得到了良好的控制，並且病情沒有繼續擴散。

On October 22nd, the Global Vitiligo Foundation and the online community, My-Vitiligo-Team, hosted a public webinar on clinical trials for patients with vitiligo. As a proud sponsor of the GVF, our trial was featured and we've been very pleased with interest levels. Today, all 15 sites are up and running and 8 of 23 subjects have been enrolled. We continue to plan for completion of enrollment at the end of this calendar year and approval in 2023.

10月22日，全球白斑症基金會 (GVF) 和線上社群 My-Vitiligo-Team 舉辦了一場關於白斑症患者臨床試驗的公開網路研討會。作為 GVF 的贊助商，我們的試驗受到了廣泛關注，我們對大家的關注程度感到非常滿意。目前，所有 15 個試驗點均已啟動並投入運行，23 名受試者中已有 8 名完成入組。我們計劃在今年底完成入組工作，並於 2023 年獲得批准。

To support the vitiligo opportunity, our products team is developing a new fully automated version of the RECELL system tailored for the dermatology setting. Dermatologists see high volumes of vitiligo patients and this version of RECELL will automate some steps and specifically the skin scraping step to make best use of physician and nursing staff time.

為了協助白斑症治療，我們的產品團隊正在開發一款專為皮膚科設計的全新全自動 RECELL 系統。皮膚科醫生接診的白斑症患者數量龐大，而這款 RECELL 系統將自動執行部分步驟，特別是皮膚刮取步驟，從而最大限度地利用醫生和護理人員的時間。

Work progresses 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 for rejuvenation. Both groups have preliminary proof of concept experiments ongoing. The work to date gives us confidence that the methods developed will yield successful proof of concept in animal models 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復興方面的合作正在取得進展。這兩個團隊都正在進行初步的概念驗證實驗。迄今為止的工作讓我們有信心，我們開發的方法將在今年年底前在動物模型上成功驗證概念。

I would now like to walk you through the growth drivers we see ahead. We continue to drive forward on provider engagement and education, whether in person or virtual. Our discussions have shifted from whether or not to use RECELL and today our focus is on optimizing the use of RECELL as well as training and refining the expertise of support staff.

現在，我想向大家介紹一下我們預見的未來成長動力。我們將繼續推動供應商的參與和教育，無論是線下還是線上。我們的討論已經從是否使用RECELL轉移到了優化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 mass of burn centers and with that, we are focused on penetration within those accounts. We have shown that our strategy of driving into smaller burn results in overall broader RECELL usage.

我們的商務團隊將繼續推動燒傷中心客戶的滲透。我們已獲得VAC認證，我們認為這些中心已達到一定數量，因此我們專注於在這些客戶中提升滲透率。事實證明，我們推進小型燒傷中心的策略能夠帶來更廣泛的RECELL使用率。

To underscore our approach, today over one-third of RECELL procedures involved burn that are less than 10% TBSA or total body surface area, and the smaller burns represent about three quarters of burn admissions.

為了強調我們的方法，今天超過三分之一的 RECELL 手術涉及小於 10% TBSA 或總體表面積的燒傷，並且較小面積的燒傷約佔燒傷入院人數的四分之三。

On November 2nd, CMS published the 2022 Medicare Outpatient Prospective Payment System with payment going into effect in January of 2022. Based on this, a C code will be assigned to RECELL which we anticipate will cover the cost of the device for all Medicare patients. We plan to then commence a pilot launch at key sites to ensure coverage with commercial carriers before proceeding with the broader nationwide launch in mid-2022.

11月2日，CMS發布了2022年Medicare門診預付費系統，該付費系統將於2022年1月生效。據此，RECELL將被分配一個C代碼，我們預計它將為所有Medicare患者支付該設備的費用。我們計劃隨後在主要站點進行試點，以確保商業運營商的覆蓋，然後在2022年中期在全國範圍內進行更廣泛的推廣。

Our pipeline initiatives are continuing to move forward, more specifically we are excited about progress within our vitiligo trial which should complete enrollment at year-end as well as our soft tissue trial which now has 58 of 65 patients enrolled with the uptick driven by the recent increase in trauma-related accidents.

我們的管道計畫正在繼續向前推進，更具體地說，我們對白斑症試驗的進展感到興奮，該試驗將在年底完成招募，以及我們的軟組織試驗，目前已有 65 名患者中的 58 名招募，由於最近創傷相關事故的增加而有所上升。

We continue to be optimistic about our preclinical pipeline work in epidermolysis bullosa and rejuvenation and we are on track to demonstrate proof of concept by the end of the calendar year. We are determining our future steps and path forward with the FDA. Our next goal is to review the GLP data requirements to submit in the application for first in human treatment and once timelines are clear, I will update you accordingly.

我們繼續對大皰性表皮鬆解症和再生療法的臨床前管線工作持樂觀態度，並有望在今年年底前完成概念驗證。我們正在與FDA商討未來的步驟與發展方向。我們的下一個目標是審查首次人體治療申請中提交的GLP資料要求，一旦時間表明確，我會及時更新。

Moving to our last growth driver, we plan to broaden our geographic footprint over the coming years. COSMOTEC, our commercial partner in Japan has revised its approval strategy to focus on burns initially based on Japanese Health Authority or PMDA feedback. The Japanese Health Authority is working through a backlog of applications and we had been advised to expect approval in the first half of 2022.

說到我們最後一個成長動力，我們計劃在未來幾年擴大業務覆蓋範圍。我們在日本的商業合作夥伴COSMOTEC已根據日本衛生部或PMDA的回饋修改了其審批策略，最初將重點放在燒傷治療上。日本衛生部正在處理積壓的申請，我們先前被告知預計在2022年上半年獲得批准。

Upon approval, COSMOTEC will meet next year with the Japanese Ministry of Health, Labor and Welfare or MHLW to present RECELL for reimbursement review which we anticipate will occur in June. COSMOTEC will then launch to burn customers shortly thereafter. Once we have vitiligo and soft tissue data from our U.S. pivotal trials, COSMOTEC will seek regulatory and reimbursement approval for those indications as well.

獲得批准後，COSMOTEC 將於明年與日本厚生勞動省（MHLW）會面，提交 RECELL 的報銷審核，我們預計審核將於 6 月進行。 COSMOTEC 隨後將很快將面向燒傷患者推出。一旦我們在美國獲得白斑症和軟組織治療的關鍵試驗數據，COSMOTEC 將同時尋求針對這些適應症的監管和報銷批准。

In summary, despite continued pressure on procedures largely due to recent hospital staffing challenges, we have made substantial progress across our business. While we anticipate continued staffing headwinds in the near term, I'm pleased with how our commercial team has responded, driving advanced practice training and keeping RECELL front and center in the minds of burn care practitioners.

總而言之，儘管近期醫院人手短缺導致燒傷治療流程持續承壓，但我們的業務仍取得了長足進步。雖然我們預計短期內人員短缺問題仍將持續存在，但我對我們的商業團隊的應對措施感到滿意，他們積極推動高級實踐培訓，並始終將RECELL技術置於燒傷護理從業人員的首要位置。

Finally and looking further ahead, the substantial progress in our clinical trials for vitiligo and soft tissue trauma reflect a groundswell of interest in and the potential of these larger market opportunities.

最後，展望未來，我們在白斑症和軟組織創傷臨床試驗中取得的實質進展反映了人們對這些更大市場機會的興趣和潛力。

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. Total revenue for the three months ended September 30, 2021 was $7 million, an increase of $2 million or 39% over the $5.1 million reported for the same period in 2020. The increase was largely driven by broader utilization among our customer base as well as deeper penetration within the individual customer accounts.

謝謝，麥克。截至2021年9月30日的三個月，總營收為700萬美元，較2020年同期的510萬美元增加200萬美元，增幅39%。成長主要得益於我們客戶群的廣泛使用以及個人客戶帳戶滲透率的提高。

Gross profit margin for three months ended September 30, 2021 was 85% compared to 82% reported for the same period in 2020. Higher gross margin was driven by lower shipping cost and increased production at our Ventura facility. Total operating expenses for the three months ended September 30, 2021 was 12.3 million, a decrease of $2.7 million or 18% over the $14.9 million reported for the same period in 2020.

截至2021年9月30日的三個月，毛利率為85%，而2020年同期為82%。毛利率上升的原因是運輸成本降低以及文圖拉工廠產量增加。截至2021年9月30日的三個月，總營運費用為1,230萬美元，較2020年同期的1,490萬美元減少270萬美元，降幅為18%。

The decrease in operating expenses is primarily attributable to lower stock-based compensation and higher cost in the prior year related to the AVITA Group's redomiciliation to the United States along with severance cost associated with a former executive. This was partially offset with higher travel costs in the current year due to fewer COVID-19 related travel restrictions. Lower stock-based compensation was driven by higher share-based compensation expenses in the prior year associated with certain performance milestones being met.

營運費用的下降主要歸因於股票薪酬的減少，以及上一年AVITA集團遷址至美國相關成本的增加，以及與一位前高階主管相關的遣散費。由於新冠疫情相關的旅行限制減少，本年度差旅費用的增加部分抵消了上述影響。股票薪酬的減少是由於前一年因達到某些業績里程碑而產生的股票薪酬費用增加。

Net loss for the three months ended September 30, 2021 was $5.9 million, a decrease of $4.5 million or 42% over the $10.2 million loss recognized during the same period last year. The decrease in net loss was driven by the lower operating expenses described above and higher revenue during the three months ended September 30, 2021. As of September 30, 2021, the company had $60.4 million in cash and cash equivalents and $49.5 million in short term and long term marketable securities as well as no debt.

截至2021年9月30日的三個月，淨虧損為590萬美元，較去年同期的1,020萬美元減少450萬美元，降幅達42%。淨虧損的減少得益於上述營運費用的降低以及截至2021年9月30日的三個月期間收入的增加。截至2021年9月30日，本公司擁有6,040萬美元的現金及現金等價物，4,950萬美元的短期及長期有價證券，且無任何債務。

Moving on to guidance for our second fiscal quarter, we expect total revenue in the second fiscal quarter to be approximately 7 million. This guidance reflects the anticipated impact of hospital staffing challenges as well as uncertainty with the pandemic. I would also like to announce that the company will change to effective December 31, 2021, a calendar year basis for financial reporting.

談到我們第二財季的業績指引，我們預計第二財季總收入約為700萬美元。該指引反映了醫院人員配置挑戰以及疫情帶來的不確定性所帶來的預期影響。我還想宣布，公司將從2021年12月31日起改為以日曆年為財務報告基準。

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

最後，感謝您的關注，現在我將把電話轉回給接線員以回答您的問題。

Thank you. (Operator Instructions).

謝謝。 （操作員指示）。

Our first question comes from Josh Jennings with Cowen. Your line is open.

我們的第一個問題來自Cowen的Josh Jennings。您的電話已接通。

Hi, this is Eric on for Josh. Thanks for taking the question. I was hoping to touch on guidance for fiscal 2Q year, expecting $7 million now and we're almost halfway through the quarter. I was hoping if you could just talk about the trends that you're seeing through October and early November here that is driving your guidance and then what is baked in for the remainder of the year?

大家好，我是 Eric，接替 Josh。感謝您回答這個問題。我想談談第二財季的業績預期，目前預計為 700 萬美元，而本季已經過了一半。您能否談談截至 10 月和 11 月初的業績趨勢，這些趨勢影響了您的業績預期？今年剩餘時間的業績預期如何？

I'm going to toss that one over to Erin, our Chief Commercial Officer, to respond to. Erin?

我要把這個問題交給我們的首席商務官艾琳來回答。艾琳？

Sure, sure. There's a lot of things that are going on in the market, some are seasonal which we anticipate and some are kind of relating to the staffing challenges. So, typically in the fall we see a seasonality, right, and so we're just coming out of that seasonality where you see a bit of a depression in terms of procedures. And then, you see a kind of -- usually in the November, December timeframe really starting to pick up.

當然，當然。市場上有很多事情正在發生，有些是我們預料到的季節性因素，有些則與人員配置挑戰有關。通常，秋季會出現季節性變化，對吧？我們剛走出季節性低迷期，在這段時間裡，業務流程會略顯低迷。然後，你會看到——通常在11月和12月，業務開始真正回升。

So, November, December, January is very high and then the several months of July is also quite high. So, we have seasonality and kind of coming out of that and then as I mentioned into the holidays we certainly see kind of an uptick in terms of procedures. We have at the end of our year a rebate scheme where we often see customer kind of buying up at the end of year for the rebate.

11月、12月和1月的銷售額非常高，7月這幾個月的銷售額也相當高。所以，我們受到季節性的影響，而且隨著這種季節性的逐漸消退，正如我之前提到的，在假期期間，我們的業務量肯定會有所回升。我們在年底推出了返利計劃，我們經常看到客戶為了獲得回饋而在年底大舉購買。

On the flip side though, we are dealing with some staffing challenges, nursing staffing challenges. And just to kind of get into that a little bit more, what we're encountering right now is there are burn procedures ongoing. Many burn procedures are getting rescheduled to odd times such as night times or weekends. There's a lot of what we're calling traveling nurses going around, it's covering kind of the gap. And at times or at times, there's just not the necessary staff needed.

但另一方面，我們也面臨一些人員配置方面的挑戰，尤其是護理人員配備方面的挑戰。更詳細地說，我們目前面臨的問題是，燒傷手術仍在進行中。許多燒傷手術被安排到夜間或週末等特殊時間進行。我們所謂的「巡迴護士」四處奔波，填補了人員缺口。有時，我們根本沒有足夠的人手。

So, a lot of surgeons are not comfortable doing a RECELL procedure without someone there on staff that is -- has done many, many procedures before. So, you know, we're there kind of filling the gaps and do a lot of training but at the end of the day we can't provide care and there's just certain times where the surgeon wants to have someone there that's on their team that has done a case before and that we're running into some challenges. And so, that is kind of the two dynamics that are -- that are kind of contradicting I guess each other.

所以，很多外科醫生在缺乏經驗豐富的團隊的情況下，很難進行RECELL手術。所以，你知道，我們只是在填補一些空白，也做了大量的培訓，但最終我們無法提供治療。有些時候，外科醫生希望團隊裡有一位之前做過病例的人，而我們遇到了一些挑戰。所以，我想，這兩種情況是互相矛盾的。

Thanks Erin. Does that answer your question, Eric?

謝謝 Erin。這回答了你的問題嗎，Eric？

It does, that's great. Thank you. And then, maybe if I could ask one more, just on the vitiligo trial, you have 8 of 23 subjects enrolled, just thinking about any headwinds that we could have towards the end of the year in terms of scheduling just where is your confidence that's going to make the enrollment goes, that all 15 sites are up and running and that's going to accelerate?

確實如此，太好了。謝謝。然後，我可以再問一個問題嗎？就白癜風試驗而言，您目前招募了23名受試者中的8名，您考慮一下我們在年底時間安排方面可能遇到的阻力。您對招募工作進展順利嗎？您對所有15個試驗點是否都能正常運作以及試驗進程是否會加速有信心？

Is there any read-through from your soft tissue enrollment as things pick up that perhaps that would somehow apply to your vitiligo trial? I'm just trying to understand where these additional patients are going to be picking up. Thank you.

隨著情況的好轉，你們的軟組織研究招募工作是否有任何進展，或許可以應用在你們的白斑試驗？我只是想了解這些新增患者將來自哪裡。謝謝。

Yes, so we have a number of patients in the queue that are being evaluated and for specific detail on that I'm going to pass it over to Andrew Quick, our Chief Technology Officer. Andy?

是的，我們排隊等候的患者中有一些正在接受評估，至於具體細節，我將把它交給我們的首席技術官安德魯·奎克 (Andrew Quick)。安迪？

Thanks Mike. Thanks Eric for your question. So, soft tissue and vitiligo are different because with vitiligo we can drive recruitment. We have mentioned I think before our multimedia, online, et cetera recruitment effort including radio. That has enabled us to fill a pipeline.

謝謝邁克。謝謝埃里克的提問。所以，軟組織和白斑症是不同的，因為對於白斑症，我們可以推動招募。我們之前提到過，我們的多媒體、線上等等招募工作，包括廣播。這使我們能夠填補人才缺口。

So beyond the eight who are enrolled today, eight more are scheduled and an additional 10-plus have met the criteria and they're in process of consenting and scheduling. So, obviously that puts us over the 23 and that's really the basis for our confidence. With soft tissue, it's more of a waiting game for someone to turn up with an injury.

所以，除了今天報名的8名患者外，還有8名患者已安排好，另有10多名患者已符合標準，正在等待知情同意和安排。所以，顯然，我們已經超過了23名患者，這也是我們信心滿滿的基礎。對於軟組織手術來說，更像是一場等待受傷患者到來的遊戲。

That's helpful. Thank you, guys.

這很有幫助。謝謝大家。

Thanks, Eric.

謝謝，埃里克。

Thank you. Our next question comes from 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。您的電話已接通。

Thanks so much. Just a quick clarification for Mike P., the commentary about soft tissue being Q1 2022 enrollment completed. But then the approval by the end of 2023, is that calendar or fiscal? I just want to make sure I'm clear on that?

非常感謝。我只想快速澄清一下 Mike P. 的說法，關於軟組織計畫將在 2022 年第一季完成註冊。那麼，2023 年底前獲得批准，是日曆年還是財政年度？我只是想確認一下我是否清楚這一點？

Calendar.

日曆。

Calendar, got it. Okay and then just to follow up a little bit on Eric's question on this dynamic about staffing shortages and these strange times are some of these cases are scheduled? I'm just wondering when do you think some of these issues may abate a little bit more, is it really Delta variant driven, so maybe it continues here in this calendar or sort of this fiscal quarter and then less so next calendar year or is this something that maybe a headwind for the next several quarters?

日曆，明白了。好的，接下來我想稍微跟進一下Eric的問題，關於人員短缺的動態，以及這些特殊時期的一些案件是如何安排的？我只是想知道，您認為這些問題什麼時候會有所緩解？它是否真的受達美航空變體的影響？所以，也許它會在本財季或本財季持續下去，然後在下個財年逐漸減少？或者，這可能會成為未來幾季的阻力？

It could last longer. I'm not sure if it's going to be several quarters but I really don't believe that it's specifically the Delta variant. It's really the dynamic of what's happening relative to vaccination requirements and some nurses not necessarily wanting to take the vaccination as well as as Erin mentioned earlier these traveling nurses, they're getting paid substantially more than the regular nursing staff.

這種情況可能會持續更長時間。我不確定是否會持續幾個季度，但我真的不認為這只是德爾塔變異株的問題。真正的問題在於疫苗接種要求的動態變化，以及一些護士不一定願意接種疫苗，正如艾琳之前提到的，這些巡迴護士的工資比普通護理人員高得多。

And then the regular nursing staff are either becoming traveling nurses or taking early retirement because they just don't see the viability or the fairness in the situation. Anything you would want to add to that, Erin?

然後，常規護理人員要么成為巡迴護士，要么提前退休，因為他們覺得這種做法既不現實，也不公平。艾琳，您還有什麼補充嗎？

No. I think that's -- unfortunately, yes, we don't have a crystal ball. I agree with you, it's not necessarily Delta related. I think burn -- the nurses are just burnt out. I think, it was interesting on the BTIG, on Ryan Thurman's call this morning, right, that some have just, they're being lured away to other industries. Some of them have felt that nursing was just not for them.

不。我認為——很遺憾，是的，我們沒有水晶球。我同意你的觀點，這不一定和達美航空有關。我認為護士們只是精疲力盡了。我覺得，在BTIG，在Ryan Thurman今天早上的電話會議上，有一點很有意思，就是有些人被挖走了，去了其他行業。有些人覺得護理工作不適合他們。

At the last week's Southern ABA, the average age of a burners is 59, right? So, that's much older and so some of them are retiring, and also nursing is a specialized field. So, it takes six months to 12 months to kind of -- really kind of do a preceptorship and it gets specialized in that particular area to really be kind of to excel. So, I think, there's just so many variables. I hope it doesn't last a long time and things kind of settle down but I certainly don't think it's going to be --

在上週的南方ABA大會上，護理員的平均年齡是59歲，對吧？這年紀要大得多，有些人已經退休了，而且護理是一個專業領域。所以，需要6到12個月的時間才能真正完成導師制，並在特定領域中專業化，才能真正出類拔萃。所以，我認為變數太多了。我希望這種情況不要持續太久，事情會就此穩定下來，但我絕對不認為會這樣——

It's not going to go away in a quarter.

它不會在一個季度內消失。

Yes.

是的。

For sure.

一定。

Yes.

是的。

Okay but to be clear, though, you guys aren't losing accounts, you're still -- you still have those accounts? They're just -- they're just not (inaudible).

好的，不過要說清楚，你們並沒有遺失帳戶，你們仍然──你們仍然擁有那些帳戶嗎？它們只是——它們只是沒有（聽不清楚）。

Yes, absolutely.

是的，絕對是。

-- as often. Okay and then --

—— 常常這樣。好的，然後——

Correct.

正確的。

-- sorry, just one more quick one. On the --

——抱歉，我再問一個問題。關於——

Fair, Matt.

公平地說，馬特。

-- outpatient side, certainly great to see the pastor update. I'm just wondering if you can give us a sense for how impactful that could be to the business as we enter calendar 2022? Thanks so much.

——門診方面，很高興看到牧師的最新消息。我想請問您能否告訴我們，在進入2022年之後，這會對業務產生多大的影響？非常感謝。

Sure, Matt. So, the CPT code is very valuable to us, especially in the long run. In the short-term, it really has to do with the adoption curve. And as we've said many times, the surgeons start out on larger burns and in combination in full thickness burns, with a mesh split thickness skin graft. It's at the end of that adoption curve that they go to the smaller wounds and burns that could be treated in the outpatient setting.

當然，馬特。所以，CPT 代碼對我們來說非常有價值，尤其是從長遠來看。短期來看，它實際上與採用曲線有關。正如我們多次提到的，外科醫生首先處理大面積燒傷，並結合全層燒傷，進行網狀中厚皮移植。在採用曲線的末端，他們才會處理可以在門診治療的小面積傷口和燒傷。

So, initially with only burns approved at this point, the impact is going to be relatively modest. But as we get soft tissue approved, that's really going to be a very important component of our revenue. So, Erin, anything to add on that?

所以，目前只有燒傷治療獲批，影響相對較小。但隨著軟組織治療獲批，這將成為我們收入的重要組成部分。那麼，Erin，您還有什麼要補充的嗎？

The only other thing I would say is of our serviceable addressable market, the $260 million,$ 60 million of that is for burns underneath 10% total body surface area.

我唯一想說的是，我們的可服務目標市場為 2.6 億美元，其中 6,000 萬美元用於治療全身表面積 10% 以下的燒傷。

Right.

正確的。

Which outpatient is a big chunk of that, right? So with COVID, it's a little murky in terms of how many are inpatient versus out because a lot of them have transitioned more so heavier to outpatient but that's kind of -- that's kind of the size of the segment that we're running after that TPT will help us with.

門診病人佔了很大一部分，對吧？所以對於新冠疫情，要確定有多少是住院病人，有多少是出院病人，有點困難，因為很多重症患者已經轉為門診病人，但這就是我們目前運營的細分市場的規模，TPT 會幫我們處理這個規模。

Got it. Thank you.

明白了。謝謝。

Thank you, Matt.

謝謝你，馬特。

Thank you. Our next question comes from 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。

Good morning, all and thank you for taking my question . I'm just going to follow on from the conversation that was previously had about the nursing staff and trying to understand if the approval or launch of RECELL 2.0 will help alleviate I guess some of that nursing staff issues, particularly with ease-of-use and reduction in the handling of the device?

大家早安，感謝您回答我的問題。我想繼續之前關於護理人員的討論，想了解一下RECELL 2.0的批准或推出是否有助於緩解護理人員面臨的一些問題，尤其是在設備易用性和減少操作方面？

Yes, thank you, Lyanne for your question. I think that the new device will help somewhat. Certainly, one only needs a single pair of hands in the sterile field, and as I mentioned, it's cutting down the number of steps by approximately a third.

是的，Lyanne，謝謝你的提問。我覺得新設備會有所幫助。當然，在無菌區只需要一雙手，而且正如我所提到的，它能將步驟減少大約三分之一。

That said, there are still issues relative to burn nurses that are qualified that have experience in doing the procedures and having the burn surgeons comfortable that they have staff that are going to accurately utilize the device and have been trained sufficiently. Because, generally the surgeons like to take the initial skin sample as well as do the spray-on but they try to dedicate the other elements of the RECELL procedure to other practitioners, nurses and advanced care specialists.

儘管如此，仍存在一些問題，例如燒傷護理師是否具備資格和經驗，以及燒傷外科醫生是否能夠準確使用該設備並接受過充分培訓。因為通常外科醫生喜歡採集初始皮膚樣本並進行噴霧，而他們通常會將RECELL程序的其他環節交給其他從業人員、護士和高級護理專家來完成。

Okay, thank you. And just one more question on the Japanese markets, obviously some delays there with respect to approval. Can you give us an indication of the size of the Japanese market if you break it down in terms of burns versus the other indication, so that we can just get a handle on how we think revenues my ramped up over time?

好的，謝謝。還有一個關於日本市場的問題，顯然日本的審核有些延遲。您能否按燒傷量和其他適應症來細分，告訴我們日本市場的規模，以便我們了解收入是如何隨著時間推移增長的？

Sure, let me start off and then I'll pass it over to Erin but generally, as a rule of thumb, we generally look at the Japanese market as one-tenth of the U.S. market. So, you can look at that on indication by indication and take our numbers and calculate it that way. Erin, any additional that you would talk about their about Japan?

當然，我先說一下，然後交給Erin。一般來說，根據經驗，我們通常認為日本市場是美國市場的十分之一。所以，你可以逐一適應症地分析，然後根據我們的數據來計算。 Erin，還有什麼想補充的嗎？

Yes. So, Lyanne, we're going to have an updated corporate deck on our website in about half an hour that has a funnel for Japan for the burn segment on there. And just to give you kind of a bit more data on there, that's correct, there's about 10% -- about 10% of the size now. So, there's about 6,000 patients that have severe burns, meaning they're admitted and they may require grafting.

是的。 Lyanne，大約半小時後，我們會在網站上發布更新的公司簡報，其中有日本燒傷細分市場的漏斗圖。為了給你更多數據，沒錯，現在大約有10%——大約10%的燒傷病例。也就是說，大約有6000名重度燒傷患者，這意味著他們已經入院，可能需要植皮。

And they're saying that there's about 1,400 patients that they will be targeting with RECELL and so that's kind of the size of the population that COSMOTEC will be going after to begin with but what we don't know is kind of what the reimburse price will be. But again, that will be on the updated deck will be posted on our website in about half an hour.

他們說RECELL的目標患者大約有1400名，所以這差不多就是COSMOTEC最初要爭取的人群規模，但我們不知道報銷價格是多少。不過，更新後的方案會在大約半小時後發佈到我們的網站上。

Right. Thank you very much.

好的。非常感謝。

Is that helpful?

這樣有幫助嗎？

Very Helpful. Thank you.

非常有幫助。謝謝。

Sure, Lyanne.

當然，萊安娜。

You're welcome.

不客氣。

Thank you. (Operator Instructions).

謝謝。 （操作員指示）。

Our next question comes from Brooks O'Neil with Lake Street Capital. Your line is open.

下一個問題來自Lake Street Capital的布魯克斯·奧尼爾。您的線路已開通。

Good afternoon, everyone. I'm hoping you could just amplify a little bit. Obviously, when I think about the burn business, burns are happening there, I assume the patients are getting treated. So, in some ways it comes down to a question of, are we going to do old fashioned skin graft or are we going to use RECELLs?

大家下午好。我希望你們能稍微詳細說一下。當然，當我想到燒傷這件事時，我當然會想到那裡有燒傷病例，所以我認為病人正在接受治療。所以，從某種程度上來說，這可以歸結為一個問題：我們是要採用傳統的植皮方法，還是要使用RECELL技術？

And are you saying that the phenomenon you're seeing out there is that the nurses and doctors are opting for sort of the old fashioned treatment now because they don't really know how to use your system or how -- what are you seeing out there?

您是否說，您所看到的現像是，護理師和醫生現在選擇某種老式的治療方法，因為他們真的不知道如何使用您的系統或如何——您看到了什麼？

Yes. It's -- Brooks, thanks for the question, first of all. It's really -- it's not the surgeons. The surgeons are, yes, there's a number who are retiring as well as a number who are moving from one center to another but that's not really of substantial impact, what is, is the nursing staff.

是的。布魯克斯，首先謝謝你的提問。問題真的不是外科醫生。外科醫生確實有很多人退休了，也有很多人在從一個中心調到另一個中心，但這並沒有造成實質的影響。真正影響的是護理人員。

And when a physician or burn surgeon feels that they don't have the right competency in the nursing staff, they will opt for a split thickness skin graft and because that's what they're taught, that's what the nurses know how to do. And to be honest, there's not a whole lot that the nurses necessarily need to assist with in the procedure as opposed to the after care where the nurses are really involved in a -- in the old model, if you will, with a thickness skin graft. So, does that answer your question?

當內科醫生或燒傷外科醫生覺得護理人員能力不足時，他們會選擇進行分層植皮，因為護士學的就是這種技術，所以他們也知道該怎麼做。說實話，與術後護理相比，護理人員不需要提供太多的協助，在術後護理中，護理人員需要真正參與其中——在以前的模式中，如果可以這麼說，就是進行分層植皮。那麼，這回答了你的問題嗎？

Yes. I mean, I totally get the way the world worked out. They're just seems a little surprising to me, given the obvious benefits of RECELL and for the patient. And frankly, from a clinical perspective, it seems to be a huge improvement over the old approach where we're putting less trauma on the body of an already traumatized patient. You would think that that would be a direction we want to go even in an environment like we've been in the last year or so.

是的。我的意思是，我完全理解這個世界是如何運作的。只是考慮到RECELL對患者顯而易見的好處，他們似乎有點讓我驚訝。坦白說，從臨床角度來看，這似乎比以前的方法有了巨大的改進，因為以前的方法會減少對已經受創傷的患者身體造成的創傷。你會認為，即使在像我們過去一年左右所處的環境中，這也是我們想要努力的方向。

Yes, you're absolutely right. I -- let me transfer the call over to Erin to give you a little bit more detail that she's getting from our field force. Erin?

是的，你說得完全正確。我——我把電話轉給艾琳，讓她給你一些她從我們外勤人員那裡得到的詳細資訊。艾琳？

Yes.

是的。

Great.

偉大的。

So, it's unfortunate because I think it's -- so when you look at our top 20 accounts or the accounts that are bigger accounts that had dedicated burn teams, that they're more -- they've got a higher chance of having someone there that has experience with RECELL because they're not -- they bought that dedicated team. That's when we're seeing them, we're seeing the strong growth in our top 20 accounts because they have that stable team and they're always having someone there that's familiar with RECELL.

所以，這很不幸，因為我認為——如果你看看我們前20個客戶，或者那些擁有專門燒錢團隊的規模更大的客戶，你會發現他們更有可能擁有熟悉RECELL的人員，因為他們沒有——他們購買了專門的團隊。我們之所以能看到前20位客戶的強勁成長，是因為他們擁有穩定的團隊，而且他們總是有熟悉RECELL的人員在那裡。

When you look at kind of the smaller accounts that have rotating teams or that they have someone in there, the surgeon just doesn't want to try something new. They're nervous to try something new because RECELL is still perceived as new in many of these accounts, without having staff that's familiar with it and I think there's just some nervousness there.

對於那些規模較小的、團隊輪調或已有專人負責的診所來說，外科醫生根本不想嘗試新事物。他們不敢嘗試新事物，因為在許多這類診所中，RECELL 仍然被認為是一種新產品，而且沒有熟悉它的工作人員，所以我認為他們確實存在一些緊張情緒。

Sure. Maybe then...

當然。也許到時候…

And then -- and this is Michael.

然後——這是麥可。

So -- go ahead, sorry.

所以——繼續吧，抱歉。

Yes, just to put this in perspective. I would say that this has impacted our caseload certainly less than to the degree of 10%, maybe 5% to 7%. So in the overall scheme of things, it hasn't made a tremendous impact. We spent a lot of time describing this qualitatively, but its overall impact is not that terrific.

是的，只是為了客觀地看待這個問題。我想說的是，這對我們案件量的影響肯定不到10%，大概在5%到7%之間。所以從整體來看，它並沒有造成巨大的影響。我們花了很多時間定性地描述它，但它的整體影響並沒有那麼大。

Great. Then, I was going to ask you just a little bit about how big an opportunity do you see in the outpatient market? And I think, Mike Perry, made a comment that the TPT, passed-through payment will facilitate reimbursement for soft tissue, I am just curious for a little extra color on sort of what you're seeing there?

太好了。那麼，我想問您一下，您認為門診市場有多大的機會？我記得Mike Perry說過，TPT（轉嫁支付）將有助於軟組織疾病的報銷。我只是想進一步了解您在這方面的看法。

Sure. So, the C code that CMS has approved and that will go into effect in January of next year, January 1st, is actually indication agnostic. So when we look at traumatic wounds and individuals presenting to trauma centers, with relatively small wounds that can be treated in the outpatient setting, yet they do require skin grafting, that's where this C code is really going to give up to our revenues.

當然。 CMS 批准的 C 代碼將於明年 1 月 1 日生效，它實際上與適應症無關。因此，對於創傷性傷口以及前往創傷中心就診的患者，如果傷口相對較小，可以在門診治療，但又需要植皮，那麼這個 C 代碼實際上會降低我們的收入。

Great, makes total sense to me. And then just one final one, we've talked over the last year or so about the opportunities in cell and gene therapy but I'm just -- since I'm not really a scientist, can you just talk a little bit about some of the things you see as exciting opportunities for the company in that broad area?

太好了，我完全明白了。最後再問一個問題，我們在過去一年左右的時間裡一直在討論細胞和基因治療領域的機遇，但我——因為我不是科學家——您能否簡單談談您認為公司在這個廣泛領域有哪些令人興奮的機會？

Sure. So, number one, we've started with an orphan disease and so far as correcting genodermatoses or genetic diseases of the skin inborn errors and we're started with epidermolysis bullosa and that is moving along well. And we anticipate having preclinical proof-of-concept that in general to generalize from EB that utilizing the RECELL system, we can take genetically modified cells, skin cells and use the spray-on technology to create new skin and that would be newly corrected skin, right? And there are a lot of other --

當然。首先，我們從一種罕見疾病入手，目前已開始研究修復遺傳性皮膚病或先天性皮膚遺傳疾病，目前我們已開始研究大皰性表皮鬆解症，目前進展順利。我們預計將進行臨床前概念驗證，從EB推廣到利用RECELL系統，我們可以提取基因改造細胞、皮膚細胞，並使用噴塗技術來創造新的皮膚，也就是新修復的皮膚，對嗎？還有很多其他的…

Yes.

是的。

-- diseases in addition to EB and that's generally a negotiation with FDA as to how many orphan diseases does one need to actually show clinical proof-of-concept in to get a broader label than just the ones that you've studied clinically. And that's -- they're-- generally they want you to study three, four various, I would say, gene mutations to show that the platform that you're utilizing is robust enough. And then it opens up another these genodermatoses another $1 billion opportunity not just for the -- yes.

除了EB之外，還有其他疾病，這通常需要與FDA協商，確定需要多少種罕見疾病進行臨床概念驗證才能獲得更廣泛的標籤，而不僅僅是那些已經進行過臨床研究的疾病。通常，他們希望你研究三到四種不同的基因突變，以證明你使用的平台夠強大。這樣一來，這又為這些遺傳性皮膚病開闢了另一個價值10億美元的商機，而不僅僅是……是的。

And then rejuvenation, where we're using RNA telomerase, that is assuming we get our proof-of-concept and we do believe that we're almost there, so it's working well. We are getting telomerase to the skin cells and we've identified that. And if that comes through, obviously that's a multi-billion dollar opportunity.

然後是煥膚，我們正在利用RNA端粒酶，前提是我們的概念驗證已經完成，而且我們確實相信我們快要成功了，所以效果很好。我們正在將端粒酶導入皮膚細胞，並且已經確認了這一點。如果成功的話，這顯然是一個價值數十億美元的商機。

And would -- we'd be looking at just describe how we would develop it. We would be looking at a real indication beyond rejuvenation to start and get the safety data. So solar elastosis, for example, where there's skin damage due to a lot of sun and sunburns, and those types of things.

我們會研究如何開發它。除了恢復活力之外，我們還會研究其他真正的適應症，並獲得安全數據。例如，日光性彈性變性，指的是因大量日曬和曬傷造成的皮膚損傷，諸如此類的情況。

There are other indications as well, but we would go into a real disease as opposed to just wrinkles and people who are looking to look younger, generate the safety data and then move as Botox did. And Erin headed up marketing at Allergan for Botox, Juvederm Lutece, so we've got a pro sitting right here.

還有其他適應症，但我們會深入研究真正的疾病，而不僅僅是皺紋和想要看起來更年輕的人，收集安全數據，然後像肉毒桿菌一樣行動。艾琳曾負責艾爾建公司肉毒桿菌產品 Juvederm Lutece 的行銷，所以我們這邊有一位專家。

It's great.

這很棒。

And everything's looking good. So I have to say, I'm very, very excited about the opportunities ahead.

一切看起來都很好。所以我必須說，我對未來的機會感到非常非常興奮。

Sounds great. Thank you very much.

聽起來很棒。非常感謝。

Thank you, Brooks.

謝謝你，布魯克斯。

Thank you. Our next question comes from 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。您的電話已接通。

Hi, good afternoon, Mike. Just a quick question first, actually yourself and Erin, just in relation to cut, just in relation to the hospitals. I mean you've talked a lot about the nursing shortage there. How much of a focus of the hospital is putting on correcting their problem or is this something that's, I mean, is that something to go away in a quarter or two but it's just a focus area for them do you think?

嗨，下午好，麥克。首先我想問您和艾琳，關於醫院的削減問題。您之前談了很多關於護士短缺的問題。請問醫院在多大程度上致力於解決他們的問題？或者說，這個問題會在一兩個季度內消失，但這只是他們目前關注的一個領域，您認為呢？

Yes, definitely. We're hearing about it in other contexts as well. It's not just with the RECELL platform. It's, overall, there is a problem with a shortage of nursing staff and hospitals are really running their nursing staff to the bone right now and we're hearing a lot about it in the general news media as well as from other companies reporting. Erin, anything else that you would want to add to that?

是的，當然。我們也在其他場合聽到類似的消息。不僅僅是RECELL平台。總的來說，護理人員短缺的問題很嚴重，醫院的護理人員現在真的人滿為患，我們在新聞媒體和其他公司的報導中也聽到了很多關於這方面的報導。 Erin，您還有什麼想補充的嗎？

Yes. I mean -- and I think, Andy, might have something as well. It's just -- it's not -- definitely not burn specific or RECELL specific, it's across the board. And it's not even nurses, it's other support staff as well, it's janitorial, it's administration, it's -- it just, overall, shortage across all resources and --

是的。我的意思是——而且我認為，安迪，可能也有一些。只是——這絕對不是燒傷或RECELL特有的，而是普遍存在的。甚至不僅僅是護士，還有其他支援人員，包括清潔人員、行政人員，總的來說，所有資源都短缺——

Yes and a lot of it is burnout of those individuals who work through the pandemic, didn't get a break and then, finally, you see that, what life's just not worth this job and they're rotating out. So, it's something that the hospitals are going to have to deal with. It won't be an overnight correction but I'm sure it will correct. Andy, anything to add?

是的，很多都是因為疫情期間一直工作的人精疲力竭，沒有休息，最後你會發現，這份工作根本不值得，他們只能輪調。所以，這是醫院必須應付的問題。雖然這不是一夕之間就能解決的，但我相信一定會好起來的。安迪，還有什麼要補充的嗎？

Yes, just we had the privilege of keynote presentation by the President of the American Nursing Association at last week Southern Region of the ABA. They held their Annual Research Meeting and the ANA is also taking an active role in combating this issue. Part of it is engaging with hospitals to make sure there's clear understanding that it's not the case that a nurse is a nurse is a nurse is a nurse.

是的，上週我們有幸在美國護理協會（ABA）南部地區會議上聆聽了美國護理協會主席的主題演講。他們舉辦了年度研究會議，美國護理協會（ANA）也積極應對這個問題。其中一項工作是與醫院溝通，確保大家清楚地體認到，護士並非只是護士，而是護士。

Nurses are specializing and the ANA is working on an accreditation program specifically for burn nurses. So, that will help and they're engaged on Capitol Hill to make sure that their voices heard with respect to what's needed to improve the situation, so there's really a lot of work ongoing from a number of different angles to remedy the situation.

護理師的專業化程度越來越高，美國燒傷護理師協會 (ANA) 正在製定專門針對燒傷護理師的認證計畫。這將會有所幫助。他們正在與國會溝通，確保他們的聲音能夠被聽到，並提出改善現狀的措施。因此，目前確實有許多工作正在從多個角度進行，以改善現狀。

Thanks, Andy.

謝謝，安迪。

Okay.

好的。

John, any -- did that answer your question?

約翰，這回答了你的問題嗎？

Yes. Yes, I mean to the extent, just sort of more or less confirms, so it's going to be a little while before you have this, then you got to retrain the new nursing staff. And it's -- and then you still have issues there as Erin sort of alluded to earlier that, doctors don't want to use RECELL device -- devices, whether or not -- whether or not supported by nursing staff or they don't have vast experience in it. So, that's sort of going to continue to be an issue for a couple of quarters (inaudible), is that correct?

是的。是的，我的意思是，在某種程度上，這或多或少證實了這一點，所以這還需要一段時間才能實現，然後你必須重新培訓新的護理人員。而且，正如Erin之前提到的，仍然存在一些問題，醫生不想使用RECELL設備——無論這些設備是否得到護理人員的支持，或者他們在這方面缺乏豐富的經驗。所以，這個問題在未來幾季還會持續存在（聽不清楚），對嗎？

Yes.

是的。

Just had a quick question for Mike Holder, if I may. Michael just in relation to the -- just sort of follow-up on your earlier scripted comments, just with the allocation of expenses there, particularly in relation to R&D. That sort of 3.4 number for the quarter, is that about right for the rest of the year do you think or is that likely to increase, decrease or anything you may add?

如果可以的話，我只想問麥克‧霍爾德一個簡單的問題。邁克爾，我想跟進一下你之前安排好的評論，關於費用的分配，特別是研發費用的分配。你認為本季的3.4%這個數字對今年剩餘時間來說差不多嗎？或者說，這個數字可能會增加、減少，或是你有什麼想補充的嗎？

Yes, thanks for the question. We actually would expect that to increase somewhat as we launch into the actual clinical trials for soft tissue and vitiligo. So, that number will be going up somewhat for the balance of the fiscal year.

是的，謝謝你的提問。隨著軟組織和白斑症臨床試驗的開展，我們預計這個數字會增加。所以，在本財年剩餘時間裡，這個數字還會上升。

Okay, that's fine. And just in the footnote there you've talked about the share-based compensation, you've amalgamated that line into the other expenses. I mean, did that sort of follow the trend from the prior year and all that expense pretty much falls into the -- into the September quarter?

好的，沒問題。剛才在註腳中您提到了股權激勵，並將其合併到其他費用中。我的意思是，這是否延續了去年的趨勢，所有費用幾乎都計入了9月當季？

No. I would say that it's spread out throughout the year. I don't have those numbers in front of me, but it just depends largely on when we hit various goals that are triggered in the stock compensation plan. So again, that will vary by quarter.

不。我想說的是，它會分散在全年。我手頭上沒有這些數字，但這很大程度上取決於我們何時實現股票薪酬計劃中觸發的各種目標。所以，每季都會有所不同。

Great. Thank you very much. That's all for me, thank you.

太好了。非常感謝。我的就到這裡，謝謝。

Thanks, John.

謝謝，約翰。

Thank you.

謝謝。

Thank you, and that's all the time we have for questions. This concludes today's conference call. Thank you for participating and you may now disconnect.

謝謝大家，我們的提問時間到此結束。今天的電話會議到此結束。感謝您的參與，現在可以掛斷電話了。

Thank you, operator.

謝謝您，接線生。