AVITA Medical Inc (RCEL) 2022 Q2 法說會逐字稿

Good day. Thank you for standing by. Welcome to the AVITA Medical Fourth Quarter 2021 and Transition Period July 1 2021 to December 31 2021 Conference Call. (Operator Instructions)

您好！感謝您的耐心等待。歡迎參加AVITA Medical 2021年第四季及過渡期（2021年7月1日至2021年12月31日）電話會議。 （操作員指示）

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

請注意，今天的會議正在錄製中。 （操作員指示）

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

現在我想將會議交給今天的發言人，投資者關係部的 Caroline Corner。

Please go ahead.

請繼續。

Thank you, Operator. Welcome to AVITA Medical's fourth quarter 2021 earnings call.

謝謝接線生。歡迎參加 AVITA Medical 2021 年第四季財報電話會議。

Joining me on today's call are Mike Perry, Chief Executive Officer, and Michael Holder, Chief Financial Officer.

參加今天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 Reform Act of 1995.

本次電話會議將包括 1995 年《私人證券訴訟改革法案》所定義的前瞻性陳述。

All statements made on this call that do not relate to matters of historical facts should be considered forward-looking statements, including statements regarding the markets in which AVITA Medical operates, trends, demand, 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.

本次電話會議中所有與歷史事實無關的陳述均應視為前瞻性陳述，包括有關 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.

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表達或暗示的任何結果、績效或成就有重大差異。

Please review AVITA Medical's most recent filings with the SEC, particularly the risk factors described in AVITA Medical's S3 and 10-K filings, and in AVITA Medical's quarterly report on Form 10-Q for the Fourth Quarter ended December 31, 2021, for additional information.

請查看 AVITA Medical 向美國證券交易委員會提交的最新文件，特別是 AVITA Medical 的 S3 和 10-K 文件中描述的風險因素，以及 AVITA Medical 截至 2021 年 12 月 31 日的第四季度 10-Q 表季度報告中描述的相關風險因素，以獲取更多資訊。

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 as 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 the fourth quarter and full-year 2021 results is available on its website, www. avitamedical.com under the Investors 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.

AVITA Medical 2021 年第四季及全年業績新聞稿可在其網站 www.avitamedical.com 的「投資者」版塊查看，其中包含更多財務業績詳情。 AVITA Medical 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。

A recording of today's call will be available on AVITA Medical 's website by 05:00 PM Pacific Time today.

今天的電話會議錄音將於今天太平洋時間下午 5:00 在 AVITA Medical 的網站上提供。

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

現在，我想將電話交給麥克，請他發表評論並介紹 2021 年第四季的業務亮點。

Thank you, Caroline. Thank you everyone, for joining us today. We are encouraged by our recent achievement of key corporate milestones, our corporate commercial performance, as well as the exciting opportunities that lie ahead for AVITA Medical. Here at AVITA Medical we are driven by our primary goal of enabling healthcare providers to restore skin, to save lives, and to improve quality of life for patients. As we expand from treating burns into 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. Total net revenue increased 37% to $14 million, compared to $10.2 million in the corresponding period in the prior year.

謝謝你，卡洛琳。感謝各位今天加入我們。 AVITA Medical 最近取得的關鍵企業里程碑、企業商業表現以及未來令人興奮的機會都令我們備受鼓舞。 AVITA Medical 的首要目標是幫助醫療保健提供者修復皮膚、挽救生命並改善患者的生活品質。隨著我們的業務範圍從燒傷治療擴展到創傷治療、白斑症治療、細胞和基因治療以及美容治療等，我們始終致力於為患者提供領先的治療性皮膚修復解決方案。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在眾多市場和適應症中充分利用我們的即時護理自體皮膚噴塗平台。今天，我很高興向大家通報我們的最新進展。總淨收入成長 37%，達到 1,400 萬美元，而去年同期為 1,020 萬美元。

For the quarter ended December 31st, 2021, our commercial revenues were consistent with our guidance at $6.9 million. With that, I'd like to highlight the recent progress that we've made with our clinical trials and the related commercial opportunities we have with soft tissue reconstruction and vitiligo. In early January, we announced completion of enrollment in our pivotal trial, evaluating the RECELL System for soft tissue reconstruction, two quarters earlier than recent guidance. Enrollment in the soft tissue reconstruction clinical trial was led by a couple of prominent trauma centers and a few prominent burn centers who are currently high-volume accounts for AVITA. This mirrors our understanding of the market opportunity and the overlap between the burns and trauma opportunities, which bodes well for the future commercialization of these indications.

截至2021年12月31日的季度，我們的商業收入與我們的預期一致，為690萬美元。在此，我想強調我們在臨床試驗方面取得的最新進展，以及我們在軟組織重建和白斑領域擁有的相關商業機會。 1月初，我們宣布完成了關鍵試驗的入組工作，該試驗評估了RECELL系統在軟組織重建中的應用，比最近的預期提前了兩個季度。軟組織重建臨床試驗的入組工作由幾個著名的創傷中心和幾個著名的燒傷中心牽頭，這些中心目前是AVITA的主要客戶。這反映了我們對市場機會以及燒傷和創傷機會之間重疊性的理解，這預示著這些適應症未來的商業化前景光明。

Top-line data are expected to be released for our soft tissue reconstruction trial during the second half of 2022, with FDA approval anticipated during the second half of 2023. As a reminder, based on our internal estimates, we foresee a total addressable U.S. market opportunity for trauma and soft tissue injury of $1 billion, which is approximately twice the size of the total addressable market for our Burns business. What's approved, we anticipate leveraging our installed base of burn centers to treat traumatic wounds, especially those that present to burn centers that are co-located with trauma centers.

我們軟組織重建試驗的頂線數據預計將於2022年下半年發布，FDA預計2023年下半年批准。需要提醒的是，根據我們的內部估計，我們預計美國創傷和軟組織損傷的潛在市場總額將達到10億美元，約為我們燒傷業務潛在市場總額的兩倍。對於已獲批准的方案，我們預計將利用我們現有的燒傷中心來治療創傷性傷口，尤其是那些與創傷中心位於同一地點的燒傷中心就診的傷口。

Furthermore, we plan to be selling the RECELL System to approximately 220 Level 1 and Level 2 trauma centers, where we will approach plastic and reconstructive surgeons, as well as traditional trauma surgeons. We plan to incrementally expand our sales force to promptly address this opportunity post-approval. We remain excited about our improved ease-of-use device, which was designed with considerable input from surgeons and users. The ease-of-use device allows for improved surgeon and staff handling by no longer requiring a second pair of hands outside the sterile field, and a reduction in device handling steps by one-third, thereby providing significant time savings to surgeons and or staff. We're pleased to share with you that the FDA has approved the pre -market approval application or PMA for our new RECELL System with improved ease-of-use. The U.S. launch is planned to commence in Q2 of this calendar year.

此外，我們計劃將 RECELL 系統銷售給大約 220 家一級和二級創傷中心，我們將在這些中心接觸整形和重建外科醫生以及傳統創傷外科醫生。我們計劃逐步擴大銷售隊伍，以便在獲準後迅速抓住這項機會。我們對改進後的易用性設備感到興奮不已，該設備的設計充分考慮了外科醫生和使用者的意見。此易用性設備無需在無菌區域外配備第二雙手，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，從而為外科醫生和/或工作人員節省了大量時間。我們很高興告訴大家，FDA 已批准我們全新易用性改良型 RECELL 系統的上市前核准申請（PMA）。該系統計劃於今年第二季在美國上市。

Our improved ease-of-use device will also allow AVITA Medical to better address our burns outpatient market facilitated by the new Transitional Pass-Through Payment or TPT code issuance. As the TPT code is indication agnostic, it will also apply to our soft tissue repair indication, once approved. This represents another meaningful step on our pathway to becoming the standard of care in acute wounds and provides further opportunity to extend our intellectual property estate. We are additionally continuing to fervently support the development of our next-generation automated skin preparation device to produce Spray-On Skina Cells.

我們改進的易用設備也將使 AVITA Medical 能夠更好地應對燒傷門診市場，這得益於新的過渡性轉付代碼 (TPT) 的發布。由於 TPT 代碼與適應症無關，一旦獲得批准，它也將適用於我們的軟組織修復適應症。這標誌著我們在成為急性傷口護理標準的道路上又邁出了意義重大的一步，並為擴展我們的智慧財產權資產提供了更多機會。此外，我們將繼續大力支持下一代自動化皮膚準備設備的開發，以生產噴霧式 Skina 細胞。

Turning to our pipeline vitiligo indication, in December, we completed enrollment of our pivotal trial for the use of the RECELL System for re-pigmentation of stable vitiligo. Top-line data from our vitiligo pivotal trial are expected to be released during the second half of 2022 with PMA approval and U.S. commercial introduction anticipated by the end of 2023. 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. 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 progress.

談到我們研發的白斑症，我們在12月完成了關鍵性臨床試驗的入組工作，該試驗旨在利用RECELL系統對穩定性白斑症進行色素沉著重建。我們白癜風關鍵性試驗的主要數據預計將於2022年下半年發布，並預計於2023年底獲得上市前許可（PMA）批准和在美國上市。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呈白色斑點或斑塊狀，主要由患者潛在的自體免疫疾病引起。全球約有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130萬人患有穩定性白斑，這是我們的目標族群。這意味著他們潛在的自體免疫疾病得到了良好的控制，並且病情沒有繼續惡化。

Based upon our internal estimates, we foresee a total addressable U.S. market for RECELL in vitiligo of $5.2 billion. Last month for the first time, RECELL was presented on podium at the annual Maui Durham 2022 conference to 650 in-person participants and many others attending virtually. Dr. Pearl Grimes, Director of the Vitiligo and Pigmentation Institute of Southern California, and Dr. John Harris, Professor and Chair of Department of Dermatology at the University of Massachusetts Medical School and UMass Memorial Medical Center discussed the latest approaches to creating vitiligo, melisma and other disorders of pigmentation. Dr. Harris shared RECELL as a potential treatment for vitiligo along with multiple cases from outside the United States, and provided an overview of our vitiligo study design. Since this presentation took place, we have experienced a very nice uptick in interest from the dermatological community.

根據我們的內部估算，我們預計美國 RECELL 白斑症治療的潛在市場總額將達到 52 億美元。上個月，RECELL 首次在 2022 年毛伊達勒姆年會上亮相，吸引了 650 名現場與會者和眾多線上與會者。南加州白癜風和色素沉著研究所所長 Pearl Grimes 博士和馬薩諸塞大學醫學院及馬薩諸塞大學紀念醫學中心皮膚病學系教授兼主任 John Harris 博士共同探討了治療白斑症和其他色素沉著障礙的最新方法。 Harris 博士分享了 RECELL 作為白斑潛在治療方法的案例，並介紹了多個來自美國以外的病例，並概述了我們的白斑症研究設計。自從這次演講以來，我們注意到皮膚病學界對此的興趣顯著提升。

Looking ahead to March, our team is excited to participate in three key annual meetings taking place in Boston, namely The Global Vitiligo Foundation or GVF, annual scientific symposium, the skin of color society and the American Academy of Dermatology or AAD meeting. Of note, there are 10 sessions featuring vitiligo, which is a market increase from last year. As JAK inhibitors from Pfizer, (inaudible), and Insight and the RECELL System have stimulated substantial interest. As a reminder, JAK inhibitors are primarily focused on controlling the underlying autoimmune disease that causes the white patches. If effective, the JAK inhibitors will increase the total pool of stable vitiligo patients available for re-pigmentation with RECELL.

展望三月，我們的團隊非常高興能夠參加在波士頓舉行的三個重要的年度會議，分別是全球白斑基金會（GVF）年度科學研討會、有色人種皮膚協會和美國皮膚病學會（AAD）會議。值得注意的是，今年有10場會議以白斑為主題，比去年的市場規模有所成長。輝瑞（聽不清楚）、Insight和RECELL系統的JAK抑制劑引起了人們的濃厚興趣。需要提醒的是，JAK抑制劑主要專注於控制導致白斑症的潛在自體免疫疾病。如果JAK抑制劑有效，將增加可透過RECELL系統進行色素沉澱治療的穩定白斑患者的總數。

In addition to completing our enrollment in our pivotal soft tissue and vitiligo trials, AVITA Medical recently established proof-of-concept for novel treatments and skin rejuvenation and an epidermolysis bullosa. In partnership with researchers at the Houston Methodist Research Institute, or HMRI, preclinical data demonstrating successful proof-of-concept was achieved when pairing RECELL for harvesting and delivery of skin cells. With HMRI's, patented RNA technologies to reverse age the skin cells prior to delivery. Personalized cellular levels, skin rejuvenation is an area of significant interest for consumers with a total addressable market of over $15 billion. More than 3 million aesthetic procedures are performed annually in the United States, with approximately 1 million people undergoing facelifts and various tightening procedures each year.

除了完成關鍵軟組織和白斑症試驗的患者招募外，AVITA Medical 最近還針對新型療法、皮膚再生和大皰性表皮鬆解症進行了概念驗證。 AVITA Medical 與休士頓衛理公會研究所 (HMRI) 的研究人員合作，結合 RECELL 技術收集和遞送皮膚細胞，獲得了臨床前數據，證明概念驗證成功。 HMRI 的專利 RNA 技術可在細胞再生之前逆轉老化。個人化細胞層級的皮膚再生是消費者非常感興趣的領域，其潛在市場總額超過 150 億美元。美國每年進行超過 300 萬例美容手術，其中約有 100 萬人接受臉部拉皮和各種緊實手術。

In partnership with scientists at the Gate Center for Regenerative Medicine at the University of Colorado School of Medicine. We achieved preclinical proof-of-concept for a novel therapeutic aim to treat Recessive Dystrophic Epidermolysis Bullosa or RDEB. Patients with RDEB have a mutation in their Col 781 gene, which leads to severe skin fragility resulting from their skin cells ' inability to produce the protein needed that normally secures the epidermis and dermis to one another. Epidermolysis bullosa or EB cells have been successfully corrected and reverse-differentiated into induced into induced pluripotent stem cells or iPSCs. We had then forward differentiated iPSCs and applied them in a pre -clinical model as spray-on skin cells, successfully regenerating skin that is free of the Col 781 defect. Recessive Dystrophic Epidermolysis Bullosa is rare, and currently incurable disease, and leads to chronic wounds, and in some sub-types, an increase risk of squamous cell carcinoma or death. This represents an orphan indication with 25,000 to 50,000 patients in the United States, and a total addressable U.S. market, or TAM, estimated at $850 million. So well, I've just provided you with updates on our pipeline indications, we have also continued our progress in Burns.

我們與科羅拉多大學醫學院蓋特再生醫學中心的科學家合作，完成了一項治療隱性營養不良型大皰性表皮鬆解症（RDEB）的新型療法的臨床前概念驗證。 RDEB 患者的 Col 781 基因突變，導致皮膚細胞無法產生將表皮和真皮正常連接在一起所需的蛋白質，從而導致皮膚嚴重脆弱。大皰性表皮鬆解症（EB）細胞已成功修復，並被反向分化為誘導多能幹細胞（iPSC）。隨後，我們正向分化 iPSC，並將其作為噴霧皮膚細胞應用於臨床前模型，成功再生出沒有 Col 781 缺陷的皮膚。隱性營養不良性大皰性表皮鬆解症是一種罕見疾病，目前尚無法治愈，會導致慢性傷口，某些亞型還會增加鱗狀細胞癌或死亡的風險。這是一種孤兒藥，在美國有2.5萬至5萬名患者，其美國潛在市場（TAM）估計為8.5億美元。我剛剛向大家介紹了我們產品線適應症的最新進展，燒傷治療方面也取得了進展。

Our sales force, which we believe is the largest and most experienced Burns dedicated sales force in the market, remains focused on driving utilization and broadening penetration within our footprint of over a 100 hospitals and over 250 trained physicians. In the face of nursing and staffing shortages, we continue to prioritize training and education efforts with advanced practice providers who have a tremendous influence on the use of RECELL. Training includes local, regional, and national events for both surgeon s and their staff. In the last quarter, we held almost 600 hands-on trainings in the field, and we are currently performing approximately 200 in-hospital training sessions per month. Moving to our recent progress with reimbursement, our Transitional Pass-Through Payment or TPT Payment device category C-Code became effective January 1st of 2022.

我們的銷售團隊是市場上規模最大、經驗最豐富的燒傷專科銷售團隊，我們始終致力於提升產品利用率，並擴大我們覆蓋100多家醫院和250多名訓練有素的醫生的市場滲透率。面對護理人員和醫護人員短缺的問題，我們繼續優先考慮對RECELL應用具有巨大影響力的高級執業醫師進行培訓和教育。培訓內容包括針對外科醫生及其醫護人員的本地、區域和全國性活動。上個季度，我們在該領域舉辦了近600場實務培訓，目前我們每月進行約200場住院培訓。談到我們近期在報銷方面取得的進展，我們的過渡性轉付（TPT）支付設備類別C-Code將於2022年1月1日生效。

As a reminder, the C-Code intended to facilitate the adoption of new technology for Medicare beneficiaries by offsetting the cost of the device to facilitate the facilities, provide separate payment for RECELL used in procedures that are performed in hospital outpatient facilities and an ambulatory surgical center. The new code lays a reimbursement foundation for our soft tissue repair indication, as well as expands RECELL's burn treatment to a new care setting with existing customers. We have commenced the initial steps of a pilot launch at key sites to ensure coverage with commercial carriers and will proceed with a broader nationwide launch in mid-2022.

提醒一下，C-Code 旨在透過抵消設備成本來促進 Medicare 受益人採用新技術，從而方便設施使用，並為在醫院門診和門診手術中心進行的 RECELL 手術提供單獨付款。新代碼為我們軟組織修復適應症奠定了報銷基礎，並將 RECELL 的燒傷治療擴展到現有客戶的全新護理環境。我們已在主要地點啟動試點的初步階段，以確保商業運營商的覆蓋，並將於 2022 年中期在全國範圍內進行更廣泛的推廣。

Interest in RECELL remains high, and despite the pandemic and staffing-driven pressures on procedure rates, we are completing cases and delivering on our mission to save and improve patient's lives. We continue to hear moving stories in the media regarding the use of RECELL for the treatment of burns. One recent story came out of Chicago, highlighting Dr. Josh Carson's patient. Dr. Carson recently treated a seven-year-old boy with RECELL following a house fire, which burned 18% of his total body surface area. Dr. Carson discussed using RECELL instead of a traditional skin graft to cover the boy's burns, and was impressed with the results. Since early February, the story has received a significant amount of coverage on the Fox Network and in Newsweek. Dr. Jeff Carter was also interviewed regarding his pregnant patient who was treated with RECELL following almost 40% of her total body surface area being burned when a propane grill exploded outside her apartment complex.

人們對 RECELL 的興趣仍然很高，儘管疫情和人員配備壓力影響了手術率，我們仍在完成病例並履行我們的使命，以拯救和改善患者的生活。我們不斷聽到媒體上關於使用 RECELL 治療燒傷的動人故事。最近有一篇報導來自芝加哥，重點介紹了 Josh Carson 醫生的病人。 Carson 醫生最近在一次房屋火災中用 RECELL 治療了一名七歲男孩，該男孩全身表面積被燒傷 18%。 Carson 醫生討論了使用 RECELL 代替傳統的皮膚移植來覆蓋男孩的燒傷，並對結果印象深刻。自 2 月初以來，這個故事在福克斯網絡和《新聞周刊》上得到了大量報導。 Jeff Carter 醫生也接受了採訪，談到了他的孕婦患者，該患者在公寓大樓外的丙烷烤架爆炸後，全身表面積幾乎被燒傷 40%，隨後接受了 RECELL 治療。

This story was recently featured within the Louisiana State University Health Education network and on Science Acts. And these articles, Dr. Carter states, using spray on skin, we've been able to cut recovery times in half by accelerated healing. This means less suffering, less risk for complications and infections, and significant savings for both the patients and the state, at least $9 million of savings over three years.

這篇報導最近在路易斯安那州立大學健康教育網絡和《科學法案》上發表。卡特博士指出，這些文章表明，透過噴灑皮膚，我們能夠透過加速癒合將恢復時間縮短一半。這意味著更少的痛苦，更低的併發症和感染風險，並為患者和州政府節省大量成本，三年內至少可節省900萬美元。

With that, I'd like to now walk you through the growth drivers we see ahead. First, we continue to drive forward on provider engagement and education, whether in-person or virtual. Our discussions have progressed 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 support staff. With the pandemic lifting, we're sensing a tangible excitement around live meetings and peer-to-peer trainings. We see face-to-face interaction as a robust driver for burn surgeon adoption and with the ABA annual meeting coming up in April, we're very excited to engage in these conversations. Second, 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 burns results in overall broader RECELL usage.

現在，我想向大家介紹一下我們預見的未來成長動力。首先，我們將繼續推動醫療服務提供者的參與和教育，無論是面對面還是線上。我們的討論已經從是否使用RECELL發展到如何優化RECELL的使用，以及培訓和提升支援人員的專業技能。隨著疫情的緩解，我們感受到了人們對現場會議和同儕培訓的強烈興趣。我們認為面對面的互動是推動燒傷外科醫生採用RECELL的強大動力，隨著美國燒傷協會（ABA）年會即將於4月舉行，我們非常高興能夠參與這些對話。其次，我們的商業團隊將繼續推動燒傷中心客戶的滲透。我們已經獲得了VAC認證，我們認為在相當多的燒傷中心已經獲得了VAC認證，因此，我們專注於在這些客戶中的滲透。我們已經證明，我們推進小規模燒傷的策略可以擴大RECELL的整體使用範圍。

To underscore our approach today, over one-third of RECELL procedures involve burns that are less than 10% total body surface area or TBSA, and these smaller burns represent about three quarters of all burn emissions. In the outpatient setting with our C code in place, we have commenced our pilot launch and we're gearing up for a broader nationwide launch mid this year, as explained earlier. We also anticipate growing our commercial presence in Japan. To that end, ReCell very recently received PMDA approval of the burn's indication in Japan, and we will commercialize this indication in partnership with COSMOTEC, an M3 Group Company. As a next step, COSMOTEC will be meeting with the Japanese Ministry of Health, Labor, and Welfare, or MHLW for reimbursement review, which we anticipate will occur in the June time frame. COSMOTEC will launch to burn customers shortly thereafter. Once we have vitiligo and soft tissue data from our U.S. FDA trials, COSMOTEC will seek regulatory approval and reimbursement for those indications in Japan.

為了強調我們目前的做法，超過三分之一的 RECELL 燒傷手術涉及小於 10% 體表面積（TBSA）的燒傷，這些小面積燒傷約佔所有燒傷排放量的四分之三。在符合 C 代碼的門診，我們已經開始試點，並正準備在今年年中在全國範圍內推廣，正如之前所述。我們也期待擴大在日本的商業影響力。為此，ReCell 最近獲得了日本藥品管理局（PMDA）關於燒傷適應症的批准，我們將與 M3 集團旗下的 COSMOTEC 合作，以實現該適應症的商業化。下一步，COSMOTEC 將與日本厚生勞動省（MHLW）會面，進行報銷審核，我們預計在 6 月完成審核。此後不久，COSMOTEC 將針對燒傷患者推出產品。一旦我們從美國 FDA 試驗中獲得白斑和軟組織數據，COSMOTEC 將在日本尋求監管部門的批准和報銷。

Our third growth driver, is progress with our pipeline indications. As mentioned earlier, our soft tissue reconstruction and vitiligo clinical trials, have completed enrollment and we expect top-line data to be released in the second half of 2022, with submission of PMA supplements by the end of the calendar year. We anticipate entering the market in the second half of 2023 with both indications. Looking further out and again as mentioned earlier, our skin rejuvenation and epidermolysis bullosa pre-clinical work has achieved proof-of-concept. Our next goal is to review the GLP data requirements, to submit an IND application for your first in human treatment. And once timelines are clear, I will update you accordingly.

我們的第三個成長動力是產品線適應症的進展。如前所述，我們的軟組織重建和白斑臨床試驗已完成患者入組，我們預計將於2022年下半年發布頂線數據，並於年底前提交上市前批准補充文件。我們預計這兩個適應症將於2023年下半年上市。展望未來，如前文所述，我們的皮膚再生和大皰性表皮鬆解症臨床前工作已獲得概念驗證。我們的下一個目標是審核GLP資料要求，並提交您的首個人體治療新藥臨床試驗申請 (IND)。一旦時間表明確，我將及時更新。

In summary, despite some continued pressure on burn procedures and pandemic interruptions, we have continued to execute effectively on our business objectives, and I have achieved several key milestones. While we anticipate some continued staffing headwinds in the near-term, I'm pleased how our team has responded, driving advanced practice training, and keeping RECELL front and center in the minds of burn care practitioners. Finally, I'm looking further ahead the substantial progress in our clinical trials for vitiligo and soft tissue trauma reflect a groundswell of interest in the potential of these larger market opportunities. With that, I'll now turn it over to Michael for details on our financial performance in the quarter. Michael?

總而言之，儘管燒傷手術持續面臨壓力，且疫情造成業務中斷，但我們仍在有效執行業務目標，並且我已取得多項關鍵進展。雖然我們預計短期內人員配置方面仍將面臨一些挑戰，但我很高興我們的團隊做出了積極應對，推動了高級實踐培訓，並始終將RECELL置於燒傷護理從業人員的首要位置。最後，展望未來，我們在白斑症和軟組織創傷臨床試驗方面取得的實質進展反映出人們對這些更大市場機會的潛力日益增長的興趣。現在，我將把時間交給Michael，請他詳細介紹我們本季的財務表現。 Michael？

Thank you, Mike. Fourth quarter ending December 31st 2021, total revenue increased 35% to $6.9 million compared to $5.1 million in the corresponding period in the prior year. The increase was largely driven by broader utilization among our customer base, as well as deeper penetration within individual customer accounts. Gross profit margin was 88% compared with 84% in the corresponding period in the prior year.

謝謝，麥克。截至2021年12月31日的第四季度，總營收成長35%，達到690萬美元，而去年同期為510萬美元。此成長主要得益於我們客戶群使用率的提高，以及個人客戶帳戶滲透率的提升。毛利率為88%，去年同期為84%。

Higher gross margin was driven by increased production at our Ventura facility, lower shipping costs, and the extension of our shelf-life. Total operating expenses increased 42% to $14.8 million compared to $10.4 million in the corresponding period in the prior year. The increase in operating expenses was primarily driven by higher non-cash share-based compensation costs, higher costs with ongoing development of next-generation automated skin preparation device, pre -commercialization planning for RECELL launches in soft tissue reconstruction and vitiligo, as well as increased hands-on professional education and training events.

毛利率上升得益於文圖拉工廠產量提升、運輸成本降低、產品保質期延長。總營運費用成長42%，至1,480萬美元，去年同期為1,040萬美元。營運費用的成長主要源自於非現金股權激勵成本的增加、下一代自動化皮膚準備設備持續開發成本的增加、RECELL在軟組織重建和白斑症治療領域的商業化前期規劃，以及實踐操作專業教育和培訓活動的增加。

Higher non-cash share-based compensation costs in the current year were due to the reversal of a previously recognized expense for unvested awards related to the resignation of an executive officer in the prior year. Increased hands-on professional education and training events was driven by reduced Covid-19 related travel restrictions. Net loss increased 52% or $2.9 million to $8.5 million over the $5.6 million recognized in the corresponding period in the prior year. The increase in net loss was driven by higher operating expenses, as described earlier, partially offset by higher revenue during the year.

本年度非現金股份薪酬成本增加，是由於沖銷了上年度一位高階主管辭職相關未歸屬獎勵的先前確認費用。由於新冠疫情相關旅行限制的減少，實踐性專業教育和培訓活動增加。淨虧損較上年同期確認的560萬美元增加52%，即290萬美元，達850萬美元。如前所述，淨虧損的增加是由於營運費用增加，但部分被本年度收入增加所抵銷。

Non-GAAP adjusted EBITDA loss increased by 13%, or $0.7 million to $6.5 million, over the $5.8 million, recognized in the corresponding period in the prior year. ReCell commercial revenues were $13.8 million, while ReCell revenues associated with U.S. Department of Health and Human Services Biomedical Advanced Research and Development Authority within the office of the Assistant Secretary for preparedness and response or BARDA, were $0.2 million.

非公認會計準則 (Non-GAAP) 調整後息稅折舊攤銷前利潤 (EBITDA) 虧損增加 13%，即 70 萬美元，至 650 萬美元，而去年同期的虧損為 580 萬美元。 ReCell 的商業收入為 1380 萬美元，而 ReCell 與美國衛生與公眾服務部生物醫學高級研究與發展局 (BARDA)（負責防備和響應的助理部長辦公室）相關的收入為 20 萬美元。

Revenues associated with BARDA were attributable to our services over the vendor managed inventory for resale units purchased in the prior year. Gross profit margin was 86% compared with 83% in the corresponding period in the prior year, driven largely by the extension of our shelf life and lower shipping costs. Total operating expenses increased 7% to $27 million compared to $25.3 million in the corresponding period in the prior year. The increase in operating expenses was primarily driven by ongoing development of a next-generation automated skin preparation device, pre -commercialization planning for RECELL watches and soft tissue reconstruction and vitiligo, as well as increased hands-on professional education and training events. These higher costs were partially offset by certain one-time professional services to establish the company as a domestic filer with the SEC following completion of the AVITA Corporate Group's domiciliation to the United States and severance costs associated with a former executive employee incurred in the prior year.

與 BARDA 相關的收入歸因於我們針對上一年購買的轉售單位的供應商管理庫存提供的服務。毛利率為 86%，而去年同期為 83%，這主要得益於保質期的延長和運輸成本的降低。總營運費用成長 7%，達到 2,700 萬美元，而去年同期為 2,530 萬美元。營運費用的成長主要由於下一代自動化皮膚準備設備的持續開發、RECELL 手錶和軟組織重建及白斑產品的商業化前規劃，以及實踐專業教育和培訓活動的增加。這些較高的成本被某些一次性專業服務所部分抵消，這些服務使公司在 AVITA 企業集團完成在美國註冊後成為 SEC 的國內申報人，以及上一年與一名前高管員工相關的遣散費用。

Net loss decreased 9% or $1.5 million to $14.4 million compared to the $15.9 million recognized in the corresponding period in the prior year. The decrease in net loss was driven by higher revenue during the year, partially offset by higher operating expenses as described above. Non - GAAP adjusted EBITDA loss decreased by 17% or $2.1 million to $10.4 million, compared to $12.5 million recognized over the corresponding period in the prior year. Moving on to calendar year 2022 guidance, we project total commercial revenues of approximately $30 million, and approximate 20% increase year-over-year, excluding BARDA revenues as we emerge from Covid and increase adoption and use of the RECELL system. In calendar year 2022, we expect to realize approximately $300,000 of revenue related to BARDA. This places the company in a good position for realizing revenues from new indications in soft tissue reconstruction and vitiligo, which we anticipate will be approved in the second half of 2023. With that, we thank you for your attention, and now I will turn the call back over to the Operator for your questions.

淨虧損減少 9% 或 150 萬美元至 1,440 萬美元，而去年同期則為 1,590 萬美元。淨虧損減少是由於年內收入增加，但如上所述被營運費用增加部分抵銷。非 GAAP 調整後 EBITDA 虧損減少 17% 或 210 萬美元至 1,040 萬美元，去年同期為 1,250 萬美元。展望 2022 日曆年指引，我們預計總商業收入約為 3,000 萬美元，同比增長約 20%，不包括 BARDA 收入，因為我們擺脫了新冠疫情並增加了 RECELL 系統的採用和使用。在 2022 日曆年，我們預計與 BARDA 相關的收入約為 30 萬美元。這使公司處於有利地位，可以從軟組織重建和白斑的新適應症中實現收入，我們預計這些適應症將在 2023 年下半年獲得批准。至此，我們感謝您的關注，現在我將把電話轉回給接線員以回答您的問題。

+++qanda

+++坎達

Thank you. (Operator Instructions). Please stand by while we compile the Q&A roster. Our first question comes from Josh Jennings with Cowen.

謝謝。 （操作員指示）。請稍候，我們正在整理問答名單。第一個問題來自Cowen的Josh Jennings。

Hi, good afternoon. Thanks for taking the questions and it's been great to see the flurry of positive updates for the last couple of months. I was wondering -- just wanted to ask a question on recent trends in one (inaudible) you talked -- touched a little bit on it on the call. And just how that's impacting 2022 revenue guidance and how we should be thinking about the cadence of revenues throughout the course of now calendar 2022. And then just within that implied 20% revenue -- product revenue growth, our assumption is that most of that's coming from just the core Burn franchise, and that outpatient burn in Japan are just going to be get up and running in the back half. Any help there? Just thinking about contributions for outpatient and Japan that you have baked into your guidance.

大家下午好。感謝您回答問題，很高興看到過去幾個月來一系列積極的進展。我想問您剛才提到的近期趨勢（聽不清楚），您在電話會議上稍微提到了一點。這些趨勢將如何影響2022年的收入指引，以及我們應該如何考慮2022年全年的營收成長節奏。在隱含的20%收入（產品收入成長）範圍內，我們假設大部分收入來自核心燒傷業務，而日本的門診燒傷業務將在下半年開始恢復營運。有什麼可以幫忙的嗎？我想問一下您已納入指引的門診和日本業務的貢獻。

Thanks, Josh, nice to talk to you. Appreciate your questions. Recent trends, and certainly have an impact on what we've projected as guidance relative to growth going forward. That said, we are anticipating much less impact from Covid, so this includes really an abatement of Covid. That said also, the nursing staff situation that is continuing to rotate in nursing staff due to a national shortage we anticipate, will continue.

謝謝，喬希，很高興和你聊天。感謝你的提問。最近的趨勢，當然也會對我們預測的未來成長指引產生影響。話雖如此，我們預計新冠疫情的影響會小得多，這實際上包括了疫情的減弱。此外，我們預計，由於全國範圍內護理人員短缺，護理人員輪調的情況還會持續下去。

And that really have us continuing our training at a very high rate. So about that, that's all baked in. Regarding outpatient and Japan, your second part of your question. I would agree those are more intended to start kicking in in the second half of the year. Also, just to remind you regarding Japan. While we do have PMDA approval, in around the June timeframe, COSMOTEC, our partner in Japan will be meeting with the MHLW to establish reimbursement and then they'll be able to kick off their sales. So we don't anticipate a whole lot of revenue from Japan in calendar '22.

這確實促使我們以非常高的速度繼續進行訓練。關於這一點，一切都已融入其中。關於門診和日本，也就是您問題的第二部分。我同意這些計劃更傾向於在下半年開始生效。另外，關於日本，我想提醒您。雖然我們確實獲得了日本藥品管理局（PMDA）的批准，但大約在6月份，我們在日本的合作夥伴COSMOTEC將與厚生勞動省（MHLW）會面，確定報銷事宜，然後他們就可以開始銷售了。因此，我們預計2022年日本市場的收入不會很高。

Thanks for that. And a follow-up question. It's just on the new RECELL device that was approved? And how is your internal team thinking about this new device driving stronger utilization rates at U.S. burn centers increasing or stronger early adoption rates in the outpatient arena? Or should we be thinking about really some of the pipeline indications for this new device and the ease-of-use will really kick in particularly in the state of vitiligo once that's approved?

謝謝。還有一個後續問題。這僅僅是關於新核准的RECELL設備嗎？您的內部團隊如何看待這款新設備能夠提高美國燒傷中心的使用率，還是提高門診領域的早期採用率？或者我們應該真正考慮這款新設備的一些適應症，以及一旦獲得批准，它的易用性是否會真正發揮作用，尤其是在白斑症治療方面？

Thanks again, Josh. Good question. We anticipate that while number one, we're extraordinarily excited by the ease-of-use machine that is now approved. So from that perspective generally, I would say we're getting a level of enthusiasm. It's something new that we can talk about, and it's a value there. Regarding really driving revenues, this is more of a longer-term value proposition for the company. It will certainly drive some in the outpatient setting in the second half of this calendar year. But where the real bang is going to come in is going to be when we achieve the soft tissue indication and reimbursement. There's going to be a lot of use their relative to the outpatient setting. And this ease-of-use device will be very good because you won't need that second pair of hands outside of the sterile field.

再次感謝，喬希。好問題。我們預計，雖然這台機器目前處於領先地位，但我們對它現在獲批的易用性感到非常興奮。所以從這個角度來看，總的來說，我認為我們正獲得一定程度的熱情。這是一件我們可以談論的新事物，而且它很有價值。至於真正推動營收成長，更像是公司的長期價值主張。它肯定會在今年下半年在門診領域帶來一些成長。但真正的爆發點在於，當我們達到軟組織適應症並實現報銷。相對於門診，它的用途會更加廣泛。而且，這種易用的設備非常棒，因為在無菌區域之外，你不需要第二雙手的幫助。

Excellent. Last question, just on soft tissue indication and just the potential, I guess priming of the pump with off-label utilization and involve the number of centers that you're planning on focusing on for the trauma centers and those centers that also have burn units. How many -- what percentages do you think is currently using RECELL off label and soft tissue cases and in front of approval, is there a chance if you're just not marketing the indication but it's being used off-label. How much experience will the trauma surgeon community have with RECELL, they've kind of primed the pump for that launch. Thanks a lot.

非常好。最後一個問題，關於軟組織適應症，以及潛在的應用潛力，我想這涉及到您計劃重點關注的創傷中心和燒傷科中心的數量。您認為目前有多少比例的醫院正在使用RECELL的超適應症治療軟組織病例？在獲得批准之前，如果您不只是推廣該適應症，而是將其用於超適應症治療，是否有機會？創傷外科醫生群體對RECELL的使用經驗有多少？他們已經為RECELL的上市做好了準備。非常感謝。

Thanks again Josh. Relative to priming the pump and having off-label use, I would say that our KOLs, especially those who are further advanced in the use of RECELL, and I'd estimate that's probably 10% to 15% have been using it in an off-label situation to treat soft tissue traumatic wounds, and this is primarily in the context of those centers, and that's about half of the ABA approved burn centers, which 136 or so, half of them are co-located with Level 1, Level 2 trauma centers. We will be adding an additional 220 Level 1, Level 2 trauma centers when we launch soft tissue. But of course, those centers aren't utilizing the product currently, it's really those burn centers that are co-located with the trauma centers.

再次感謝 Josh。關於啟動泵浦和未列入藥品說明書的使用，我想說的是，我們的 KOL，尤其是那些在使用 RECELL 方面更先進的人，我估計大概有 10% 到 15% 的人，一直在未列入藥品說明書的情況下使用它來治療軟組織創傷性傷口，這主要發生在這些中心，大約有美國燒傷協會家，其中一半與一級和二級創傷中心位於同一地點。當我們推出軟組織治療時，我們將再增加 220 個一級和二級創傷中心。當然，這些中心目前還沒有使用該產品，真正使用該產品的是那些與創傷中心位於同一地點的燒傷中心。

Great. Thank you.

太好了，謝謝。

Pleasure.

樂趣。

Our next question comes from Ryan Zimmerman with [BG].

下一個問題來自 [BG] 的 Ryan Zimmerman。

Congrats on the echo, Josh and Simon. A lot of progress has been made recently and it's nice to see. I guess, a follow-up to Josh 's question, and Mike, it's clear if there's trauma cases and there's burn cases, the two are different, but I guess where does the line end and begin there? Because are all burn cases considered part of trauma?

恭喜喬希和西蒙的迴響。最近取得了很多進展，很高興看到這一點。我想，我想補充一下喬希的問題。麥克，很明顯，創傷病例和燒傷病例是不同的，但我想這條線應該在哪裡結束，又在哪裡開始呢？因為所有燒傷病例都算創傷的一部分嗎？

And maybe just help us think about those types of cases a little bit more. I appreciate the color on the physicians' base. That's my first question, and I'll ask the second question upfront, which is: the gross margins were fantastic this quarter and I'm curious from you, Michael, what your expectations are around gross margin durability as we move into this year?

也許能幫我們多想想這類病例。我很欣賞醫生群體的豐富背景。這是我的第一個問題，我先問第二個問題：本季的毛利率非常高。 Michael，我很好奇，您對今年毛利率的持久性有何預期？

Thanks, Ryan. I'll take your first question on trauma, and really trauma and burns. When we think about it, we can group them into acute wounds. And from that perspective, the burns are being treated now with RECELL and there are some that are being treated, some trauma cases that are being treated. But again, as I answered, Josh's question, if I understood your question, there is going to be a nice overlap when we do get the indication and we can actually promote two Trauma in the burn units, as well as in the additional 220 Level 1, Level 2 trauma centers.

謝謝，Ryan。我先回答你關於創傷，尤其是創傷和燒傷的第一個問題。我們仔細想想，可以把它們歸類為急性傷口。從這個角度來看，燒傷現在用RECELL治療，有些病例正在接受治療，有些創傷病例也正在接受治療。不過，正如我回答Josh的問題時所說的，如果我理解你的意思，當我們真正獲得適應症時，兩者之間會有很好的重疊，我們實際上可以在燒傷科以及另外220個一級和二級創傷中心推廣兩個創傷科。

But, I'll broadly group those into acute wounds. And it's really an artificial regulatory concern where burns are carved out as a special acute wound indication, mostly because of the complications of ventilation injury and the like. So that's the situation there. I'll pass it over to Michael to talk about gross margins.

但我大致會把它們歸類為急性傷口。這其實是人為的監管考量，燒傷被劃歸為特殊的急性傷口適應症，主要是因為呼吸器損傷之類的併發症。情況就是這樣。我會把話題交給邁克爾，讓他談談毛利率。

Thank you, Mike. We were in fact very pleased with our gross margins which we received -- achieved rather, this past quarter at 88% and then for the six-month period at 86%. We've been working really hard, the team has on lowering our shipping costs, and they've done a great job doing that. Going forward, we would look for those costs to be more stabilized in the lower 80% range. As we roll out our ease-of-use device, it will initially have a shorter shelf life, which we will improve over time. So again, we're looking for that stabilize in the lower 80% range.

謝謝，麥克。事實上，我們對毛利率非常滿意——上個季度達到了88%，上半年達到了86%。我們一直在努力降低運輸成本，我們的團隊也做得非常出色。展望未來，我們希望這些成本能夠穩定在80%以下的範圍內。隨著我們推出易於使用的設備，它的保質期最初會縮短，但我們會逐步改善。所以，我們再次強調，我們希望毛利率能夠穩定在80%以下的範圍內。

Okay. That's helpful. And then, let us just sneak one in. You are switching to the RECELL 2.0 if you want to call it, the next-generation device kind of midway through this year. Is there any type of pacing or dynamic when you think about, potentially, inventory in the field that may have to get burned down a little bit, no pun intended, as you transition the new product in the field, and considerations for a pacing within your guidance there?

好的。這很有幫助。然後，我們再偷偷插播一個問題。如果您願意稱之為RECELL 2.0的話，您會在今年年中切換到下一代設備。當您將新產品轉移到現場時，考慮到現場庫存可能會被稍微消耗掉（這裡沒有雙關語的意思），您是否會考慮某種節奏或動態？在您的指導中，您對此有何考慮？

Yeah. That's also taken into consideration on the gross margin guidance that I just gave. We've also been focused in addition to shift on shipping cost on working on burning down the 1.0 inventory, along with the commercial teams thoughtful rolling out of the 2.0, so that's something that we're very much looking to optimize and be efficient towards, and that again, falls into the guidance that I gave you.

是的。我剛才給出的毛利率指引也考慮到了這一點。除了降低運輸成本外，我們也致力於減少1.0版本的庫存，同時商務團隊也積極推出2.0版本。所以，這是我們非常希望優化和提高效率的目標，這也符合我之前給的指引。

Okay. Thank you. I'll hop back in the queue.

好的。謝謝。我這就回到隊列。

Thanks, Ryan.

謝謝，瑞安。

Our next question comes from Lyanne Harrison with America.

下一個問題來自《美國》的 Lyanne Harrison。

Hi, Mike. Hi, Michael. Thank you for taking my questions. Can I start with, I guess, the transition as you go from the original RECELL to RECELL 2.0? What's the -- in terms of the end-use and the results from the RECELL, is it the same irrespective of which device is used?

你好，Mike。你好，Michael。謝謝你回答我的問題。請問你能先從最初的RECELL過渡到RECELL 2.0嗎？就最終用途和RECELL的效果而言，無論使用哪種設備，效果都一樣嗎？

Yes. The end result is exactly the same.

是的。最終結果完全一樣。

Okay.

好的。

What we've done is -- yeah, decreased the steps as I mentioned by a third and increased -- enhanced the user experience.

我們所做的是 - 是的，正如我所提到的，將步驟減少了三分之一，並增強了使用者體驗。

Is the expectation as you launch RECELL 2.0 that eventually your entire surgeon population will start -- will move towards using that product, given that it's the easier to use product?

當您推出 RECELL 2.0 時，您是否期望最終您的所有外科醫生群體都會開始使用該產品，因為它更容易使用？

Yes. That is our intent.

是的。這就是我們的意圖。

Okay. And with all of the training that's been conducted at the moment, is that being -- are the nurses being trained for RECELL 2.0?

好的。目前所有的訓練都已經進行了，護理師們是否正在接受 RECELL 2.0 的訓練？

Not yet. Primarily, they're being trained on what is currently available. And that will be transitioning though. And there's just a time of training due to the nursing staff continuing to turn over. As they turn over, they're also -- it's not like you get a turnover and they're there for two or three months. This is really -- it's a number of weeks and then they turn over again. So it's constant training.

還沒有。他們主要接受的是現有資源的訓練。但這需要一段時間的過渡。由於護理人員的輪換，培訓也需要一段時間。輪換期間，他們也會…這不像是一次性的輪換，他們只會在那裡待兩三個月。實際上，他們要待幾週，然後再輪調。所以培訓是持續的。

Okay. Thank you. If I can just -- if you could provide some color, obviously, with RECELL that was approved for pediatric burns. Can you give us some color on the trend of what you're seeing in terms of the split of procedures between pediatrics and adults at the moment?

好的。謝謝。請問您能否提供一些關於RECELL的信息，該藥物已獲批用於治療兒童燒傷。您能否介紹一下目前兒科和成人燒傷治療的差異趨勢？

Sure. Pediatrics. Well, we have the indication now and we can promote to pediatric centers. The centers that -- which is by and large the majority of them, which treat both adults and children initially did not differentiate at all between the adults and pediatrics. So we've really already taken that into account in our current revenues. So there may be a small bump on the pediatric only hospitals where previously we couldn't promote, but most of that is already baked in.

當然，兒科。嗯，我們現在有了適應症，可以推廣到兒科中心。那些同時治療成人和兒童的兒科中心——基本上是大多數——最初根本沒有區分成人和兒科。所以我們目前的收入已經考慮到了這一點。因此，之前我們無法推廣的兒科醫院的收入可能會略有增長，但大部分已經考慮到了。

Okay thank you. And just one last question for me is, can you give us some guidance on operating costs for 2022 calendar year?

好的，謝謝。最後一個問題，您能否為我們提供2022年度營運成本的指導？

Michael?

麥可？

Yes. You bet. So as you know from our earnings release and the script, if you exclude BARDA revenues year-over-year, we're expecting roughly a 20% increase, and as I look at operating expenses, I would say that the increase in operating expenses would be roughly commensurate with that.

是的，沒錯。正如你從我們的財報和計劃中了解到的，如果扣除BARDA的收入，我們預計將同比增長約20%。至於營運費用，我認為營運費用的成長與此大致相當。

And as you might imagine, that's largely driven by research and development given the clinical trials that will be intensifying with vitiligo and soft tissue, as well as continued other pipeline work with our next-generation device. So that will be the larger of our three main expense categories.

如你所想，這主要得益於研發支出，因為白斑症和軟組織疾病的臨床試驗將會加強，而且我們下一代設備的其他研發工作也持續推進。所以，研發支出將是我們三大支出類別中較大的一項。

The second category that would increase would be sales and marketing. As you would imagine, we're continuing to grow in Burns as well as getting to prepare for additional commercialization activities down the road with vitiligo and with soft tissue. And then lastly, you have G&A expenses which would increase at a more minor way.

第二類會增加的是銷售和行銷。正如你所想的，我們在燒傷科的業務持續成長，同時也為未來在白斑症和軟組織科開展的更多商業化活動做準備。最後，一般及行政費用（G&A）會增加得比較少。

Thank you very much. I'll leave it there.

非常感謝。我就不說了。

Thanks, Lyanne.

謝謝，Lyanne。

Thank you.

謝謝。

Our next question comes from Matthew O'Brien with Sandler.

我們的下一個問題來自桑德勒的馬修奧布萊恩。

Thanks for taking my question. Maybe just a follow-up a little bit on Josh's first question on '22 the RECELL revenue is basically a little bit of growth out of your exit rate for '21, so Mike, I'm wondering if you're just assuming the headwind on the nursing side, it's just -- you face it all year or are you assuming that it starts to abate a little bit in the back half of the year because, again, there's not a lot of growth off of that exit rate in Q4?

感謝您回答我的問題。或許可以稍微跟進一下 Josh 第一個問題，2022 年 RECELL 的收入基本上比 2021 年的退出率略有增長。所以 Mike，我想知道您是否只是假設護理方面存在阻力，您全年都會面臨阻力，還是假設阻力會在下半年開始有所減弱，因為第四季度的退出率並沒有太大的增長？

Yeah. I realized that that growth rate of 20% is modest. And while it does not assume any major new headwinds from Covid, it does assume that the nursing shortage will not be fixed in this calendar year. And I think that's pretty much the consensus in the medical community.

是的。我意識到20%的成長率是適度的。雖然它沒有假設新冠疫情會帶來任何重大的新阻力，但它確實假設護士短缺的問題在今年不會得到解決。我認為這幾乎是醫學界的共識。

Okay. Thanks for that. Turning to trauma, can you just -- is there a specific trade show or something like that where we should expect that top-line data and then can you just talk maybe a little bit more about the next steps after we see the data in terms of getting the approval middle of next year and then how reimbursement ties into all of that?

好的。謝謝。說到創傷，您能否—是否有特定的貿易展會或類似的展會，我們可以從中獲取頂線數據？然後，您能否再多談一下，在我們看到數據之後，下一步該怎麼做，例如明年年中獲得批准，以及報銷與這一切如何關聯？

Sure. Yeah. For soft tissue, we are anticipating that top-line data in the second half of this calendar year. There is no specific meeting that we're targeting for the announcement, but we will announce it as soon as it's available, and then we will be submitting, and so far as process, there'll be the submission of the PMA for soft tissue. And then it goes into a panel track 180-day review cycle, and that's a 180 FDA days. So whenever they ask us a question, the clock goes on hold. So generally, baked about nine months into there with the back and forth. And that allows us the second half of 2023 for approval and launch.

當然。是的。對於軟組織治療，我們預計在今年下半年獲得頂線數據。目前還沒有具體的發表會，但一旦數據公佈，我們會立即公佈，然後提交申請。就流程而言，我們會提交軟組織治療的上市前許可 (PMA)。之後，我們會進入專家小組追蹤的180天審查週期，也就是FDA的180天。所以，每當他們問我們問題時，時間就會暫停。所以，通常來說，我們經過反覆討論，大約需要9個月的時間。這樣，我們就有時間在2023年下半年獲得批准並上市。

And we do anticipate that the launch is going to be let's say, relatively smooth. And we anticipate vitiligo it's going to be smooth as well. But the point of call is completely different for vitiligo, whereas in soft tissue trauma, it's acute wounds, their basket basically in the same area. And we've got a lot of physicians that are already in those burn centers that are co-located with Level 1, Level 2 trauma centers relative to the rollout. So hopefully that gives you a little bit of color. Did that answer your question?

我們確實預計啟動過程會相對順利。我們預計白斑症治療也會順利。但白斑症的診療重點完全不同，而軟組織創傷是急性傷口，它們的診療範圍基本上相同。而且，我們有許多醫生已經在燒傷中心工作，這些中心與一級、二級創傷中心位於同一地點，方便進行相關工作。希望以上資訊能給您一些幫助。這回答了您的問題嗎？

Yes. That's really helpful.

是的。這真的很有幫助。

The last one is for Michael Holder -- just to follow-up on the last question on OPEX. You're in a pretty good cash position, but there's just a lot going on at the company. Could you talk about cash needs?

最後一個問題是邁克爾·霍爾德（Michael Holder）的——關於營運支出（OPEX）的最後一個問題。你們的現金狀況相當不錯，但公司內部有很多事情要做。能談談現金需求嗎？

Obviously, you're not going to be doing anything this year, but just the position of the company as we head into all of these launches, second half of next year and then into '24 as well.

顯然，你今年不會做任何事情，而只是在我們進入所有這些發布會、明年下半年以及 24 年時確定公司的定位。

Yes. You bet. Great question.

是的。沒錯。問得好。

Fortunately we do have a very strong cash position in excess of $100 million. If you look at the cost that we plan to expand, leading to commercialization of vitiligo and soft tissue reconstruction, and you exclude costs associated with our cell and gene therapy programs, we have ample amount of cash and we would not need to do additional fundraising prior to reaching cash flow breakeven, according to our plans.

幸運的是，我們擁有超過1億美元的雄厚現金。如果算上我們計劃擴張的成本，包括白斑和軟組織重建的商業化，並扣除細胞和基因治療項目相關的成本，我們擁有充足的現金，根據我們的計劃，在實現現金流盈虧平衡之前，我們不需要進行額外的融資。

But having said that, as a best practice, we would always like to keep at least 1.5 times our cash burn on hand as a good business practice. So we do anticipate that we'll need to, and we'll want to, fundraise at some point in the future but we're not pressed to do that any time soon. That could occur any time between now and the next couple of years.

但話雖如此，作為最佳實踐，我們始終希望保持至少相當於我們現金消耗量1.5倍的現金儲備，這才是良好的商業慣例。因此，我們確實預期未來某個時候需要、也希望進行融資，但我們不會在短期內被迫這樣做。這可能發生在現在到未來幾年之間的任何時間。

Got it. Thank you so much.

明白了。非常感謝。

One sec, Matt, I just wanted to add one additional comment that came to my mind while Michael was speaking, and that is, for the soft tissue reconstruction, it's the same reimbursement process and basically the same codes that would be utilized there. So that's another advantage that the soft tissue reconstruction indication has.

馬特，等一下，我只是想補充一下麥可講話時我想到的一點，那就是軟組織重建的報銷流程和程式碼基本上相同。所以，這也是軟組織重建適應症的另一個優點。

Got it. Okay. Very helpful. Thank you both.

明白了。好的。非常有幫助。謝謝兩位。

Thanks, Matt.

謝謝，馬特。

(Operator Instructions) Our next question comes from Shane Ponraj with Morningstar.

（操作員指示）我們的下一個問題來自晨星的 Shane Ponraj。

Hello, Thanks for taking my question. Just thinking about the sales trajectory for Burns with commercial revenue in the last three quarters. It's been roughly flat at around $7 million and your guidance suggests a similar rate for the next four quarters. When I think about approval for pediatric centers, reimbursement for outpatient RECELL 2.0 Japan launch, they are all great updates, but it doesn't seem like you think this will significantly contribute to the top line. Is that fair to say? And if so, do you think this will become meaningful down the track?

您好，感謝您回答我的問題。我只是想了解Burns過去三個季度的商業收入走勢。它大致持平在700萬美元左右，您的指引也顯示未來四季的成長將維持類似水準。我考慮到兒科中心的獲批，以及日本推出RECELL 2.0門診治療的報銷，這些都是很棒的更新，但您似乎認為這些不會對營收產生顯著的貢獻。這樣說公平嗎？如果是這樣，您認為這些在未來會有什麼意義嗎？

I think that the -- I'm going to start with a response, Shane, and then I'll pass it over to Michael Holder. But from my perspective, the answer is yes. That these are going to have a small impact in 2022. Down the line, they're definitely going to have a substantially material impact as we move forward. Michael, is there anything you'd like to add to that?

我認為——肖恩，我先回覆一下，然後交給麥可霍爾德。但從我的角度來看，答案是肯定的。這些措施在2022年的影響會很小。但從長遠來看，隨著我們未來的發展，它們肯定會產生實質的影響。邁克爾，您還有什麼想補充的嗎？

Basically, I would just wholeheartedly agree with that. And just to be clear, whereas commercial revenues have been relatively flat the last three quarters, we are projecting as we come out of Covid, 20% growth. As Mike said, we are expecting a small impact from the various factors you mentioned in '22. But in '23, we're expecting those to really help us with our revenue growth rate. And so we would look, although we haven't provided guidance, we would look for our revenue growth rates to increase materially in '23.

基本上，我完全同意這一點。需要明確的是，儘管過去三個季度商業收入相對持平，但我們預計，隨著新冠疫情的結束，我們的收入將成長20%。正如麥克所說，我們預計您提到的各種因素在2022年的影響較小。但在2023年，我們預期這些因素將真正幫助我們提高收入成長率。因此，儘管我們尚未提供業績指引，但我們預計2023年的營收成長率將大幅提升。

Yes. But for calendar '22, regarding $30 million, it's sort of just over $7 million per quarter. You've talked about the staffing shortage limiting sales. But is there anything else that you can maybe point to which is weighing on sales at the moment?

是的。但就2022年而言，約3,000萬美元，相當於每季700多萬美元。您之前提到過人員短缺限制了銷售。您能指出目前還有其他因素影響了銷售嗎？

It's really the reopening of the hospitals, and while we're seeing that occur, it's happening at a, I would say, a slower pace than we would generally like to see, of course. But the hospitals are really being, I would say, slow, at changing their procedures, and they are lagging behind. There are various regions in the United States are stopping their masking rules and for the vaccinated that is, and changing their restrictions.

這實際上是醫院的重新開放。雖然我們看到了這種情況，但我認為，它的進展速度當然比我們通常希望看到的要慢。但我認為，醫院在改變流程方面確實進展緩慢，而且落後了。美國許多地區正在取消口罩佩戴規定，特別是針對已接種疫苗的人，並改變限制。

Yes. That's really all that I see there.

是的。我在那裡看到的確實就這些。

Okay. No worries. Just sounds like you're a lot more positive about soft tissue reconstruction. It sounds like that's really overtaken vitiligo as your big break and where you're most confident in.

好的。別擔心。聽起來你對軟組織重建的態度要正面得多。聽起來這已經超越了白斑，成為你最大的突破，也是你最有信心的領域。

Is that fair? Would you characterize that -- what would you characterize that to when you compared the two? And to mainly because it's more adjacent to the burns area you operate in.

這樣公平嗎？您覺得這兩者有什麼不同嗎？您覺得這主要是因為它離您手術的燒傷區域更近。

Just going to the D oh. Sorry. Keep going.

我要去D哦。抱歉。繼續。

No. You go.

不，你走吧。

Okay, Shane. It's really because of the adjacency to burns and the reimbursement that's basically in place and number of surgeons that do both burns as well as soft tissue reconstruction. We do anticipate an easier transition to staffing up where we currently have field salespeople and just really increasing that. Whereas vitiligo is substantially larger business opportunity and top line revenue growth opportunity for us. But we don't have established reimbursement there.

好的，Shane。這主要是因為燒傷治療與燒傷治療相鄰，而且報銷制度基本上到位，而且有很多外科醫生同時進行燒傷和軟組織重建手術。我們確實預計，在目前擁有現場銷售人員的情況下，人員配置的過渡會更容易，而且會大幅增加現場銷售人員。而白癜風對我們來說是一個更大的商業機會和營收成長機會。但我們目前還沒有建立該領域的報銷制度。

We're very positively inclined and excited about the indication. But it will be the usual new indication, new reimbursement, new point of call going through and getting that done. We're doing as much as we can pre-approval to be ready. But it takes time to actually get launched and get rolling and getting the hockey stick on that.

我們對這項適應症非常樂觀，也非常興奮。但一切照舊，我們會像往常一樣，審查新的適應症、新的報銷、新的診療點，並儘快完成。我們正在盡最大努力做好預先審批的準備。但真正啟動、推進，並最終取得進展，還需要時間。

Understood. Thanks very much.

明白了。非常感謝。

Thanks, Shane.

謝謝，肖恩。

Thank you. Our next question comes from John Hester with Bell Potter.

謝謝。下一個問題來自貝爾·波特的約翰·赫斯特。

Good afternoon, Michael and Mike. Earlier in the call, you've talked about Josh Carson, I just a quick Google searched, and it said Loyola Burn Center. Can you tell us a little bit more about that center, are they one of your top users or would you classify them as a new user, Mike? And what growth, how many kits are they using, or these guys versus more or less a one-off?

下午好，麥可和麥克。剛才在電話會議中，你們提到了喬希·卡森，我快速谷歌了一下，結果顯示是洛約拉燒傷中心。麥克，您能否詳細介紹一下該中心？他們是你們的主要用戶之一嗎？還是說您認為他們只是新用戶？成長情況如何？他們使用了多少套件？或者說，這些設備是一次性使用的，還是一次性使用的？

This was -- number one, Loyola is a center that does use ReCell on a regular basis. They're not our top center, but they do a reasonable volume. Relative to projections, we have not given any guidance relative to center-by-center projections. So really can't answer that. Probably could follow up with a bit more detail offline.

這是——首先，洛約拉大學確實經常使用ReCell。他們不是我們最好的中鋒，但他們的用量也還算合理。關於預測，我們還沒有提供任何關於每個中鋒的預測指引。所以真的無法回答這個問題。或許可以線下跟進，提供更多細節。

This one perhaps we'll talk later -- later in the day. Thank you very much. That's all.

這個問題我們稍後再談——今天晚些時候。非常感謝。就這樣。

Thank you, John.

謝謝你，約翰。

Thank you. I'm currently showing no further questions at this time.

謝謝。目前我沒有其他問題。

This concludes today's conference call. Thank you for participating. You may now disconnect.

今天的電話會議到此結束。感謝您的參與。您可以掛斷電話了。