AVITA Medical Inc (RCEL) 2024 Q1 法說會逐字稿

Good day, and thank you for standing by, and welcome to the AVITA Medical, Inc., first-quarter 2024 earnings conference call. (Operator Instructions) Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Jessica Ekeberg, Director of Investor Relations. Please go ahead.

大家好，感謝您的支持，歡迎參加 AVITA Medical, Inc. 2024 年第一季財報電話會議。（操作員指示）請注意，今天的會議正在錄音。現在，我想將會議交給今天的發言人、投資者關係總監 Jessica Ekeberg。請繼續。

Thank you, operator. Welcome to AVITA Medical's first-quarter 2024 earnings call. Joining me on today's call are Jim Corbett, Chief Executive Officer; and David O'Toole, Chief Financial Officer. Today's earnings release and presentation are available on our website, www.avitamedical.com, under the Investor Relations section.

謝謝您，接線生。歡迎參加 AVITA Medical 2024 年第一季財報電話會議。參加今天電話會議的還有執行長 Jim Corbett；以及財務長 David O'Toole。今天的收益報告和簡報可在我們的網站 www.avitamedical.com 的「投資者關係」部分中找到。

Before we begin, I'd like to remind you that this call includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are neither promises nor guarantees and involve known and unknown risks and uncertainties that could cause actual results to differ materially from any expectations expressed or implied by the forward-looking statements.

在我們開始之前，我想提醒您，本次電話會議包含 1995 年《私人證券訴訟改革法案》所定義的前瞻性陳述。這些聲明既不是承諾也不是保證，並且涉及已知和未知的風險和不確定性，可能導致實際結果與前瞻性聲明中表達或暗示的任何預期有重大差異。

Please review our most recent filings with the SEC for comprehensive descriptions of the risk factors. Any forward-looking statements provided during this call are based on management's expectations as of today.

請查看我們最近向美國證券交易委員會提交的文件，以了解風險因素的全面描述。本次電話會議中提供的任何前瞻性陳述均基於管理層今天的預期。

I will now turn the call over to Jim for his comments.

我現在將電話轉給吉姆，請他發表評論。

Thank you, Jessica. Good afternoon, and thank you for joining us today. I will begin today's call by discussing our financial and business results of the first quarter, followed by our priorities and outlook for 2024. Following this update, I'll turn the call over to David, who will provide commentary on our financial performance for the quarter before opening the call to Q&A.

謝謝你，潔西卡。下午好，感謝您今天加入我們。我將在今天的電話會議上首先討論我們第一季的財務和業務業績，然後討論我們的優先事項和 2024 年的展望。在這次更新之後，我將把電話轉給戴維，他將對我們本季的財務表現發表評論，然後開始問答環節。

This was a disappointing quarter for us. Our first-quarter commercial revenue of $11.1 million not only fell short of our expectations, but it also marked the first time since my arrival that we did not achieve sequential quarterly growth. While we are encouraged by certain aspects of our business, such as our distribution agreement with Stedical in early January, it's important to address the challenges we encountered in meeting our revenue targets.

對我們來說這是一個令人失望的季度。我們第一季的商業收入為 1,110 萬美元，不僅低於我們的預期，而且這也是我上任以來我們首次未能實現連續季度增長。雖然我們對業務的某些方面感到鼓舞，例如我們 1 月初與 Stedical 達成的分銷協議，但解決我們在實現收入目標方面遇到的挑戰也很重要。

Let me begin by providing more color on the revenue guidance announcement made on April 10. At the time of this announcement, we were faced with several challenges that hindered our ability to provide comprehensive insights into our performance, and I understand the frustration this may have caused our investors. Not to justify or minimize our performance, it's important to note that under ASX rules, we had to promptly issue the market announcement despite not having financial statements completed for the quarter, nor having analyzed external data.

首先，我想對 4 月 10 日發布的收入指引公告提供更多詳細資訊。在發布此公告時，我們面臨著多項挑戰，這些挑戰阻礙了我們提供全面業績洞察的能力，我理解這可能會給我們的投資者帶來挫折感。並非為了證明或貶低我們的表現，需要注意的是，根據澳洲證券交易所 (ASX) 的規定，儘管我們尚未完成該季度的財務報表，也尚未分析外部數據，但我們必須及時發布市場公告。

Accordingly, we believed it was prudent to release what we could and to refrain from speculations, instead gather more information to provide an accurate assessment, which I'll provide in this call.

因此，我們認為明智的做法是發布我們所能發布的資訊並避免猜測，而是收集更多資訊以提供準確的評估，我將在本次電話會議中提供這些資訊。

First, as previously announced, we experienced a slower-than-expected conversion rate of new accounts for our expanded level of full thickness skin defects. Since the launch of full-thickness skin defects in June 2023 through March 31, 2024, we only added a total of 73 new accounts, of which 22 accounts were closed in the first quarter. However, we had expected an average of 15 new accounts per month for a total of 135 new accounts at the end of the first quarter.

首先，正如先前宣布的那樣，由於我們擴大了全層皮膚缺損的治療範圍，新客戶的轉換率低於預期。自2023年6月推出全層皮膚缺損業務以來至2024年3月31日，我們總共只增加了73個新帳戶，其中第一季關閉了22個帳戶。然而，我們預計平均每月新增帳戶 15 個，第一季末共新增帳戶 135 個。

While the broadened scope of full-thickness skin defects presents the opportunity to pursue multiple indications for RECELL, navigating the value analysis committee, known as the VAC approval process across the various medical specialties, including plastics, trauma, and general surgeons, and managing multiple reimbursement scenarios within a single facility have complicated the sales process beyond our initial expectations. Despite initially underestimating these complexities, we believe we will continue to become more efficient in closing new accounts.

雖然全層皮膚缺損範圍的擴大為 RECELL 尋求多種適應症提供了機會，但是需要通過價值分析委員會（即跨整形、創傷和普通外科醫生等各個醫學專業的 VAC 審批流程）以及管理單個機構內的多種報銷場景，這使銷售流程變得非常複雜，超出了我們最初的預期。儘管我們最初低估了這些複雜性，但我們相信我們將繼續更有效率地關閉新帳戶。

Looking at our current account standing on slide 3, from launch to May 10, we have had a total of 178 submissions to VACs for full-thickness skin defects. Of this, we have only had 8 rejections. In the second quarter, we expect 46 accounts to be approved. We look forward to updating you on our progress on our next quarterly call.

查看投影片 3 上的目前帳戶狀況，從發佈到 5 月 10 日，我們總共收到了 178 份針對全層皮膚缺損的 VAC 申請。其中，我們僅遭遇 8 次拒絕。在第二季度，我們預計將有 46 個帳戶獲得批准。我們期待在下次季度電話會議上向您通報我們的進度。

In addition to our account conversion rate, our burn business was significantly below our historical expectations in the quarter. To determine whether this was due to a decline in burn wound admissions or device utilization, we rely on external claims data. However, as many of you are aware, a data breach at the largest US clearing house for insurance, billing, and claims, a unit of United Health Group disrupted the data feed to our claims data provider.

除了我們的帳戶轉換率之外，本季我們的燒錢業務也大大低於我們的歷史預期。為了確定這是否是由於燒傷入院人數下降或設備使用率下降造成的，我們依賴外部索賠數據。然而，正如大家所知，美國最大的保險、帳單和索賠清算所（聯合健康集團的一個子公司）發生了資料洩露，中斷了向我們的索賠資料提供者提供資料。

Despite this disruption which happened in February, our data provider was able to secure claims data for January. Burn admissions are typically predictable and flat. However, the January data revealed a 20% lower admission rate for burn wounds compared to the three previous Januaries. Although current estimates from our data provider suggests that we will not receive February-March data until September, if admissions for these two months were flat compared to prior years, the overall admissions rate would reflect a 7% quarterly decline.

儘管二月發生了此次中斷，但我們的資料提供者仍然能夠確保一月份的索賠資料。燒傷入院人數通常是可以預測的且持平。然而，一月份的數據顯示，與前三月份相比，燒傷入院率下降了 20%。儘管根據我們數據提供者的最新估計，我們要到 9 月才能收到 2 月至 3 月的數據，但如果這兩個月的錄取人數與前幾年持平，則總體錄取率將出現 7% 的季度下降。

While we cannot accurately pinpoint the causes of our below-expectation performance for the quarter, we have initiated an enhanced coverage strategy. To supplement our understanding of burn accounts, our team of 29 clinical training specialists will be physically present at our burn account sites, dedicating at least 60% of their time in burn centers. We believe that this approach will reinvigorate our burns business.

雖然我們無法準確指出本季業績低於預期的原因，但我們已經啟動了加強覆蓋策略。為了加深我們對燒傷帳戶的了解，我們由 29 名臨床培訓專家組成的團隊將親自到燒傷帳戶現場，並將至少 60% 的時間花在燒傷中心。我們相信這種方法將會重振我們的燒傷業務。

Additionally, RECELL GO is nearing the end of its 180 day interactive review by the FDA. The 180-day period will end on May 30, 2024. Assuming approval, our top 28 burn accounts will be prioritized for conversion to RECELL GO in June. We are ready to go.

此外，RECELL GO 即將結束 FDA 的 180 天互動審查。180天的期限將於2024年5月30日結束。假設獲得批准，我們排名前 28 位的銷毀帳戶將在 6 月優先轉換為 RECELL GO。我們已經準備出發了。

See slide 4. Now let's turn our attention to our growth trajectory. We remain dedicated to establishing RECELL as standard of care for the treatment of burns now extending its application to encompass full-thickness skin defects. Furthermore, we are equally committed to transforming AVITA Medical from the single-product focus of RECELL to a broad wound-care management company. As part of this commitment, we're actively exploring wound bed preparation and dermal replacement products to identify the ideal partners and products. By expanding our portfolio to address the full spectrum of clinical needs, we believe we can improve accessibility and reach more patients.

請參閱幻燈片 4。現在讓我們把注意力轉向我們的成長軌跡。我們始終致力於將 RECELL 確立為燒傷治療的標準護理，目前其應用範圍已擴大到全層皮膚缺損。此外，我們同樣致力於將 AVITA Medical 從專注於 RECELL 的單一產品公司轉變為廣泛的傷口護理管理公司。作為這項承諾的一部分，我們正在積極探索傷口床準備和真皮替代產品，以確定理想的合作夥伴和產品。透過擴大我們的產品組合來滿足全方位的臨床需求，我們相信我們可以提高可及性並惠及更多的患者。

To better understand this strategic transformation, let's turn to slide 5. Referring to the slide, there is a broad continuum of clinical needs in burn, surgical, traumatic, and chronic wound care. Today, our portfolio includes RECELL for epidermal replacement in our co-branded dressing, PermeaDerm, which we launched in the US on March 23. PermeaDerm and the additional products we are exploring are all compatible with RECELL and each other and all can be used alongside the treatment of many of our burn and full-thickness skin defect cases to further aid in healing. Collectively, these products align with our vision to build a broad-based wound-care company.

為了更好地理解這項策略轉型，我們來看第 5 張投影片。參考幻燈片，燒傷、外科、創傷和慢性傷口護理的臨床需求範圍很廣。今天，我們的產品組合包括用於表皮置換的 RECELL，它包含在我們聯合品牌敷料 PermeaDerm 中，我們於 3 月 23 日在美國推出該產品。PermeaDerm 和我們正在探索的其他產品均與 RECELL 相容，並且彼此兼容，並且可以與我們的許多燒傷和全層皮膚缺損病例的治療一起使用，以進一步幫助癒合。總的來說，這些產品符合我們建立一家業務廣泛的傷口護理公司的願景。

See slide 6 of our presentation, which illustrates the complementary nature of RECELL and PermeaDerm and the other potential additions to our portfolio. Here's an example of a full-thickness skin defect with concern for infection. In this instance, the dark blue layer represents dressings for wound bed preparation, our current focus. This product serves as a protective antimicrobial layer in the base of the wound bed to maintain an optimal healing environment. This layer can be used in every single patient.

請參閱我們簡報的第 6 張投影片，其中說明了 RECELL 和 PermeaDerm 的互補性以及我們產品組合的其他潛在補充。這是一個擔心感染的全層皮膚缺損的例子。在這種情況下，深藍色層代表傷口床準備的敷料，這是我們目前的重點。本產品作為傷口床底部的保護性抗菌層，以維持最佳癒合環境。這一層可以用於每個病人。

The green layer represents dermal scaffolds, our other focus area. Scaffolds aim to generate vascularized tissue, further supporting definitive closure. The light blue layer represents RECELL plus a meshed split-thickness skin graft. As you are aware, this procedure provides definitive closure using significantly less skin compared to traditional autografting.

綠色層代表真皮支架，這是我們的另一個重點領域。支架的目的是產生血管化組織，進一步支持最終閉合。淺藍色層代表 RECELL 加上網狀分層皮片移植。如您所知，與傳統的自體移植相比，該手術使用更少的皮膚即可實現徹底的閉合。

Lastly is the purple layer, which is a transparent PermeaDerm dressing, optimized for protection and moisture management. By looking at the broader landscape of wound-care management and focusing on the ability to provide this continuum of wound care products, we strengthen our core business while addressing multiple needs of our customers and patients. Additionally, integrating these products into a cohesive and comprehensive portfolio allows us to leverage our large RECELL-oriented sales organization, effectively, ensuring widespread coverage across major cases.

最後是紫色層，它是透明的 PermeaDerm 敷料，針對保護和濕度管理進行了最佳化。透過審視傷口護理管理的更廣闊前景並專注於提供一系列傷口護理產品的能力，我們在滿足客戶和患者的多種需求的同時，加強了我們的核心業務。此外，將這些產品整合成一個有凝聚力和綜合性的產品組合，使我們能夠有效地利用我們龐大的以 RECELL 為導向的銷售組織，確保廣泛覆蓋主要案例。

Moving on to our international expansion strategy, we are making progress in our efforts to expand into Australia and most of the European Union through third-party distribution partnerships. We expect to execute distributor agreements in major EU countries and Australia during the remaining part of the year.

在我們的國際擴張策略方面，我們正在透過第三方分銷合作夥伴關係向澳洲和大部分歐盟地區擴張的努力中取得進展。我們預計在今年剩餘時間內與歐盟主要國家和澳洲簽訂分銷協議。

As part of our European Union efforts, we have been working with an EU notified body to obtain a CE Mark for RECELL GO under the new medical device regulation, also known as MDR. During the quarter, we passed two major MDR conformity assessment audits, and subsequently, submitted the RECELL GO technical document for review. I'm pleased to report that on April 22, 2024, the notified body confirmed that the technical document completeness check identified that all required information has been provided, and they're proceeding with a dedicated review of the submission.

作為我們歐盟努力的一部分，我們一直在與歐盟公告機構合作，以根據新醫療器材法規（也稱為 MDR）為 RECELL GO 取得 CE 標誌。本季度，我們通過了兩項主要的MDR符合性評估審核，隨後提交了RECELL GO技術文件以供審查。我很高興地報告，2024 年 4 月 22 日，公告機構確認技術文件完整性檢查確定已提供所有必需的信息，並且他們正在對提交的內容進行專門審查。

With this timeline, we expect to receive CE Mark for RECELL GO between September and December. Additionally, we are in the validation testing stage of RECELL GO mini. As a reminder, RECELL GO mini is designed to address small wounds of 480 square centimeters or less, which represents approximately 2.5% or less total body surface area. This device will have the same reusable durable as RECELL GO but will have a different cartridge that accommodates smaller donor skin samples.

按照這個時間表，我們預計將在九月至十二月期間獲得 RECELL GO 的 CE 標誌。此外，我們正處於 RECELL GO mini 的驗證測試階段。提醒一下，RECELL GO mini 專為治療面積為 480 平方厘米或更小的小傷口而設計，這大約佔身體總表面積的 2.5% 或更少。該設備具有與 RECELL GO 相同的可重複使用性和耐用性，但配有不同的墨盒，可容納較小的供體皮膚樣本。

Following the completion of validation testing, we're preparing to submit a PMA supplement for RECELL GO mini in June. This submission will receive the same breakthrough device designation that the current RECELL device was granted.

驗證測試完成後，我們準備在六月提交 RECELL GO mini 的 PMA 補充文件。該提交內容將獲得與目前 RECELL 設備相同的突破性設備稱號。

Now turning to the vitiligo initiative, our initial six-month follow-up assessments of our patients in TONE, which is our post-market study evaluating repigmentation and its impact on quality of life for vitiligo patients, are scheduled to begin in June and conclude by the end of July. With this timing, we expect we will be able to provide preliminary insights from the data during our second-quarter earnings call in August.

現在談到白斑症計劃，我們對 TONE 患者進行的初步六個月追蹤評估，這是我們的上市後研究，評估色素沉著及其對白斑症患者生活品質的影響，該評估計劃於 6 月開始，7 月底結束。透過這個時間安排，我們預計我們將能夠在 8 月的第二季財報電話會議上根據數據提供初步見解。

By this time, we will also have submitted the PMA supplement for RECELL GO mini, which will be the cartridge for treatment with vitiligo patients. As I have indicated, we plan to submit the TONE study and our separate health economic study for publication by the end of 2024, positioning us to begin commercial payer coverage discussions during the second quarter of 2025.

到此時，我們也將提交RECELL GO mini的PMA補充，這將是用於治療白斑症患者的墨盒。正如我所指出的，我們計劃在 2024 年底前提交 TONE 研究和我們單獨的健康經濟研究以供發布，以便我們在 2025 年第二季度開始商業付款人覆蓋範圍討論。

As previously discussed, we anticipate a phased rollout of commercial coverage on a regional basis with initial phase likely to begin in the fourth quarter of 2025. Our commitment to innovation and growth continues. We are steadfast in our efforts to expand our reach, drive increased adoption and sustained growth within our indications, as well as expanding our portfolio, all with the goal of delivering value to our shareholders.

如前所述，我們預計將在區域範圍內分階段推出商業覆蓋，初始階段可能在 2025 年第四季開始。我們將繼續致力於創新和發展。我們堅定不移地努力擴大我們的覆蓋範圍，推動我們產品的廣泛採用和持續成長，以及擴大我們的產品組合，所有這些都是為了為我們的股東創造價值。

Before turning the call over to David, I have an organizational update. We have retained an executive search firm to find a replacement for our Senior Vice President of Global Sales, who is no longer with the company. During this interim period, our two VPs of sales for the East and the West will report directly to me. In addition, I will be directly engaged daily with the entire commercial sales team.

在將電話轉給戴維之前，我先來更新組織狀況。我們已聘請一家高階主管獵人頭公司來尋找已離職的全球銷售資深副總裁的替代者。在此期間，我們東部和西部的兩位銷售副總裁將直接向我報告。此外，我將每天直接與整個商業銷售團隊接觸。

With that, I'd like to turn the call over to David.

說完這些，我想把電話轉給大衛。

Thank you, Jim. For the three months ended March 31, 2024, our commercial revenue was $11.1 million, which was approximately 5.8% more than the same period in 2023. However, as Jim has mentioned, this was significantly below our expectations and previous revenue guidance range. We believe we have taken the necessary steps to improve our commercial process, including VAC submissions and return to the significant revenue growth we have demonstrated in previous quarters.

謝謝你，吉姆。截至 2024 年 3 月 31 日的三個月，我們的商業收入為 1,110 萬美元，比 2023 年同期成長約 5.8%。然而，正如吉姆所提到的，這大大低於我們的預期和先前的收入指引範圍。我們相信我們已經採取了必要的措施來改善我們的商業流程，包括 VAC 提交和恢復我們在前幾個季度所表現出來的顯著的收入成長。

Beginning this quarter with the expansion of our product portfolio, we are now reporting revenue in two categories: RECELL, which will include all versions of RECELL; and wound-care products, which will be all other products such as PermeaDerm. Since the launch of PermeaDerm in the last week of March, our wound care revenue is less than 1%. However, we expect this value to increase as we add new products and our sales team gains experience selling the new products.

從本季度開始，隨著我們產品組合的擴大，我們目前報告兩類收入：RECELL，它將包括 RECELL 的所有版本；以及傷口護理產品，這些產品將是 PermeaDerm 等所有其他產品。自三月最後一周推出 PermeaDerm 以來，我們的傷口護理收入不到 1%。然而，我們預計，隨著我們增加新產品並且我們的銷售團隊累積銷售新產品的經驗，這個價值會增加。

Gross profit margin for the quarter was 86.4% compared to 84.2% in the same period in 2023. This increase is directionally where we expected it to be for 2024 with our RECELL products.

本季毛利率為 86.4%，而 2023 年同期為 84.2%。這一成長方向與我們預期 2024 年 RECELL 產品的成長方向一致。

Total operating expenses for the quarter were $26.8 million, compared to $19.4 million in the same period in 2023. The increase in operating expenses is primarily attributable to an increase of $6.1 million in sales and marketing expenses due to employee-related costs, including salaries and benefits, commissions, and travel expenses, all collectively, as a result of the expansion of our commercial organization in the second quarter of 2023 to support our growing commercial operations.

本季總營運費用為 2,680 萬美元，而 2023 年同期為 1,940 萬美元。營業費用的增加主要歸因於銷售和行銷費用增加了 610 萬美元，原因是由於我們在 2023 年第二季度擴大了商業組織以支持我們不斷增長的商業運營，導致與員工相關的成本（包括工資和福利、佣金和差旅費）增加。

G&A expenses increased by $0.7 million as a result of higher salaries and benefits, partially offset by lower stock compensation. Additionally, we incurred an increase of $0.6 million in R&D costs, which was primarily due to employee compensation costs of the medical science liaisons teams.

由於工資和福利增加，一般及行政費用增加了 70 萬美元，但股票薪酬減少部分抵消了這一增加。此外，我們的研發成本增加了 60 萬美元，這主要是由於醫學科學聯絡團隊的員工薪資成本。

Other net income/expense increased by $0.8 million of expense as we recognized $0.4 million and $0.9 million for noncash charges related to the change in fair value of our debt and warrant liability, respectively, offset by an increase of approximately $0.5 million in income related to our investment activities and other income.

其他淨收入/支出增加了 80 萬美元的費用，因為我們分別確認了與我們的債務和認股權證負債公允價值變動相關的 40 萬美元和 90 萬美元的非現金費用，但與我們的投資活動和其他收入相關的收入增​​加了約 50 萬美元，從而抵消了這一影響。

Net loss for the first quarter was $18.7 million or a loss of $0.73 per share compared to a net loss of $9.2 million were a loss of $0.37 per share in the same period in 2023. As of March 31, we had cash, cash equivalents, and marketable securities of $68.1 million compared to $89.1 million as of December 31, 2023. We acknowledge the significant use of cash during this quarter.

第一季淨虧損為 1,870 萬美元，即每股虧損 0.73 美元，而 2023 年同期淨虧損為 920 萬美元，即每股虧損 0.37 美元。截至 3 月 31 日，我們的現金、現金等價物和有價證券為 6,810 萬美元，截至 2023 年 12 月 31 日為 8,910 萬美元。我們承認本季使用了大量現金。

It's important to note that this was attributable to a number of nonrecurring items, including expenses totaling approximately $4 million for inventory purchases and other costs as part of our distribution agreement with Stedical. Of this total amount, we have approximately $3.1 million in inventory that we will recover through future product sales. Recall that our distribution agreement with Stedical provides for 50% gross margin, which means that gross sales for this inventory will be in the range of $6 million with no significant additional expense.

值得注意的是，這是由於一些非經常性項目造成的，包括總計約 400 萬美元的庫存採購費用以及與 Stedical 簽訂的分銷協議中的其他費用。在此總額中，我們有大約 310 萬美元的庫存，我們將透過未來的產品銷售收回。回想一下，我們與 Stedical 簽訂的分銷協議規定了 50% 的毛利率，這意味著該庫存的總銷售額將在 600 萬美元左右，且不會產生重大額外費用。

As we indicated, we used more cash than anticipated this quarter. However, this is not a long-term concern of ours and should not affect our ability to reach cash flow breakeven and GAAP profitability no later than third quarter of 2025.

正如我們所指出的，本季我們使用的現金超出了預期。然而，這不是我們的長期擔憂，不應影響我們在 2025 年第三季之前實現現金流收支平衡和 GAAP 獲利的能力。

Turning now to our 2024 revenue guidance, for the second quarter of 2024, we expect commercial revenues to be in the range of $14.3 million to $15.3 million. For the full year 2024, we continue to reaffirm the lower end of our previously provided guidance range of $78.5 million to $84.5 million, reflecting growth of approximately 57% at the lower end of the range over the full year 2023. Note that our annual revenue guidance now includes revenue from PermeaDerm.

現在談談我們的 2024 年收入指導，對於 2024 年第二季度，我們預計商業收入將在 1430 萬美元至 1530 萬美元之間。對於 2024 年全年，我們繼續重申先前提供的 7,850 萬美元至 8,450 萬美元的指導範圍下限，這反映出 2023 年全年該範圍下限的增長約為 57%。請注意，我們現在的年度收入指引包括來自 PermeaDerm 的收入。

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

最後，感謝您的收聽，現在我將把電話轉回給接線員以回答您的問題。

(Operator Instructions) Brooks O'Neil, Lake Street Capital Markets.

（操作員指示）布魯克斯奧尼爾（Brooks O'Neil），Lake Street Capital Markets。

Thank you, and good afternoon, everyone. I have a few questions on -- to limit it a little bit, but would you say, David, you expect that $6 million of Stedical revenue to occur in the second half of 2024? Or is it more likely that that would extend into 2025?

謝謝大家，下午好。我有幾個問題 - 稍微限制一下，但大衛，你預計 Stedicial 的 600 萬美元收入將出現在 2024 年下半年嗎？或者更有可能延續到 2025 年？

So Brooks, nice to talk with you. Thank you for the question. Thanks for attending. We haven't given any guidance on that specifically. We are still in the early days of selling PermeaDerm. I think our sales team is having some traction, but it's hard at this point in time to say how quickly that uptake is going to be. We will be able to give more guidance in August of what that PermeaDerm revenue will be for this year.

布魯克斯，很高興與您交談。感謝您的提問。感謝您的參加。我們還沒有就此給出任何具體指示。我們仍處於銷售 PermeaDerm 的早期階段。我認為我們的銷售團隊正在取得一些進展，但目前很難說這種進展會有多快。我們將在八月提供更多有關 PermeaDerm 今年收入的指導。

Great. Let me ask you a second question. I'm curious -- you didn't mention it specifically in the prepared remarks, but do you see any evidence that accounts are waiting for the approval for RECELL GO before ordering product or do you think that was not much of a factor in results in Q1 and your early look at Q2?

偉大的。讓我問你第二個問題。我很好奇——您在準備好的評論中沒有特別提到這一點，但您是否看到任何證據表明帳戶在訂購產品之前正在等待 RECELL GO 的批准，或者您是否認為這對第一季度的結果和您對第二季度的早期展望沒有太大影響？

Brooks, it's Jim. It's a good question. And I did thoroughly look at that and I don't think so. I don't think there's accounts that are waiting for that. That said, there is strong anticipation for it in many of our larger accounts.

布魯克斯，我是吉姆。這是個好問題。我確實仔細研究過這個問題，但我不這麼認為。我認為沒有帳戶在等待這一點。儘管如此，我們的許多大客戶都對此抱有強烈的期待。

Sure. That makes total sense. Okay. I'll ask the last one and then I'll turn it over.

當然。這很有道理。好的。我先問最後一個問題，然後再轉過去。

Obviously, you expanded the size of the sales organization in anticipation of the launch for full thickness, and I'm just curious if you would assess whether there was significant disruption among your entire sales organization related to that expansion or do you think that wasn't much of a factor in the results this quarter?

顯然，您擴大了銷售組織的規模以準備推出全厚度版本，我只是好奇，您是否會評估與此次擴張有關的整個銷售組織是否存在重大混亂，或者您是否認為這對本季度的業績影響不大？

So answer first and then the analysis. That's a great question because I studied that. One of my possible things that I wanted to understand better. When you look backwards, you would take the burn accounts that existed prior to June, which then -- some of them kept the same rep and some of them changed reps, right, a good majority. And in the group -- and the group actually went with a new rep, performed over the last nine months, actually slightly better than the legacy group that had stayed with their accounts. So that didn't turn out to be a cause of our challenge.

所以先回答，再分析。這是一個很好的問題因為我研究過這個問題。這是我希望更好地理解的可能的事情之一。當你回顧過去時，你會看到 6 月之前存在的燒錢帳戶，其中一些帳戶保持了相同的聲譽，而另一些帳戶則改變了聲譽，對，絕大多數都是如此。在這個群體中 — — 這個群體實際上換了一位新代表，在過去的九個月裡，其表現實際上比保留原有帳戶的舊群體略好一些。所以這並不是我們發起挑戰的原因。

Great. So you really say if I'm listening -- and I apologize for sneaking in one last little tidbit, you would say the issue really relates to the time it's taking to get through the VA committee, and at this point, you're optimistic about your ability to begin to make real progress on that process as we move into the back part of the year?

偉大的。所以您真的是說如果我在聽的話——我很抱歉偷偷地透露了最後一點，您會說這個問題實際上與通過 VA 委員會所需的時間有關，並且目前，隨著我們進入今年下半年，您對開始在這一進程上取得真正進展的能力感到樂觀？

Simply stated, yes, we feel better about it. We've had to learn how to do something that -- you know, this is, of course, not a good reason, but the fact is we had not submitted to a VAC committing virtually the previous two years, organizationally. And so when you -- when full-thickness came, it is more complex and we had a lot of them. And so we had to basically learn and develop new capabilities and skills. So we do feel better about that. We're expecting to have a very significant quarter and approvals here in Q2. So we shall see because we'll be disclosing that.

簡單地說，是的，我們對此感覺更好。我們必須學會如何去做一些事情 — — 你知道，這當然不是一個好理由，但事實是，在組織上，我們在過去兩年中幾乎沒有提交過 VAC 承諾。所以當你 — — 當全層出現時，它會變得更加複雜，而且我們有很多。因此我們必須學習和開發新的能力和技能。所以我們對此確實感覺好多了。我們預計第二季將會有一個非常重要的季度並獲得批准。我們將會看到這一點因為我們將會透露這一點。

Josh Jennings, TD Cowen.

喬許詹寧斯（Josh Jennings），TD Cowen。

Hi, this is Eric on for Josh. Thanks for taking the question. Appreciate the commentary around guidance for 2Q. With that in mind, how would you help us think about the ramp in the back half of the year to ultimately reach that full-year guidance range? What do you think the sequential steps up in 3Q and 4Q could look like?

大家好，我是 Eric，代表 Josh 發言。感謝您回答這個問題。感謝有關第二季度指引的評論。考慮到這一點，您如何幫助我們考慮下半年的成長，以最終達到全年指導範圍？您認為第三季和第四季的連續成長會是怎麼樣的？

Well, ultimately, they do get steeper, of course. We had a light first quarter. Our second quarter, we're recapturing our momentum. I think when we look at Q3 and Q4, we have committed to the lower end of our guidance, $78.5 million, so you're correct in identifying that. But what comes with that, of course, is we'll have RECELL GO launch, which will undoubtedly give us some additional growth. We'll also have been full launch with the PermeaDerm wound dressing. So we have some good additions coming aboard that will add a lot during the second half, but we haven't guided specifically to the ramp.

當然，最終它們會變得更陡峭。我們第一季的業績表現較差。在第二季度，我們正在重新獲得發展勢頭。我認為，當我們展望第三季和第四季時，我們已經承諾實現預期的低端，即 7,850 萬美元，因此您的判斷是正確的。但隨之而來的是，我們將推出 RECELL GO，這無疑會為我們帶來一些額外的成長。我們也將全面推出 PermeaDerm 傷口敷料。因此，我們有一些很好的補充，這將在下半年帶來很大的幫助，但我們還沒有具體指導如何實現這一點。

Understood. And then on the topic of VAC approvals, just out of curiosity, once the VAC committees in your customer accounts grants approval for the expanded label, how quickly are those accounts ramping RECELL utilization? Is that something that happens within a few weeks or is that something that happens right away, just curious?

明白了。然後關於 VAC 批准的話題，只是出於好奇，一旦您的客戶帳戶中的 VAC 委員會批准擴展標籤，這些帳戶的 RECELL 利用率會提高多少？這是幾週內發生的事情還是立即發生的事情，只是好奇嗎？

Well, once you get approval, then there's a process of training and uptake and selling to additional physicians. So this is a new first in category product and these trauma centers are seeing it for the first time contrary to the burns who have been using it for a few years. So there is a process where we get initial order relatively quickly. But then, of course, the real selling starts to happen with different specialties and helping physicians identify the appropriate patients. That's where our medical science liaisons actually have a big impact because their role is pure education and helping physicians think about how to treat their patients with RECELL and how they can get the results that we've seen in burns. So there is a process in terms of expanding adoption over time.

嗯，一旦你獲得批准，那麼就會有一個培訓、吸收和向其他醫生推銷的過程。因此，這是同類產品中的首創產品，這些創傷中心是第一次看到它，而燒傷患者已經使用了幾年。因此，我們可以相對快速地獲得初始訂單。但當然，真正的銷售開始發生在不同的專業領域並幫助醫生確定合適的患者。這就是我們的醫學科學聯絡員真正發揮巨大影響力的地方，因為他們的角色是純粹的教育，幫助醫生思考如何使用 RECELL 治療他們的患者，以及如何獲得我們在燒傷中看到的結果。因此，隨著時間的推移，擴大採用有一個過程。

Ryan Zimmerman, BTIG.

瑞安·齊默爾曼（Ryan Zimmerman），BTIG。

Good afternoon. Thanks for taking my question. Jim, appreciate all the color. And on the components, particularly in the back half of the year, you're including, PermeaDerm, I'm wondering, first, can you just elaborate on maybe the contributions from RECELL GO? What are you assuming for full-thickness skin defects in the back half of the year? Are you going to pick up accounts at a faster pace in the back half of the year? Just help us understand your confidence in this ramp in the back half of the year.

午安.感謝您回答我的問題。吉姆，欣賞所有的色彩。關於組成部分，特別是今年下半年，包括 PermeaDerm，我想知道，首先，您能否詳細說明一下 RECELL GO 的貢獻？您對今年下半年全層皮膚缺損的發生率有何預測？你們下半年會加快接客戶的速度嗎？只需幫助我們了解您對今年下半年這一增長的信心。

And then I think also if you throw in some of the international distributor agreements, that could certainly help offset some of this ramp. That's kind of the first question.

然後我認為，如果你加入一些國際分銷商協議，這肯定可以幫助抵消部分成長。這是第一個問題。

And then you're talking about becoming a wound-care company more, Jim, and so you need more salespeople. Are you directing your current sales force to pursue new call points? Just help us understand kind of your thinking about those initiatives as well.

然後你說要成為一家傷口護理公司，吉姆，所以你需要更多的銷售人員。您是否指示目前的銷售人員尋找新的呼叫點？也請幫助我們了解您對這些舉措的想法。

Okay. Yeah, let me try and make sure I get them all. If I don't, come back at me because this is a compound question. So first of all, let me just kind of start at the end, our vision of being a broad wound-care company, A, we don't anticipate needing additional salespeople. So that's first issue.

好的。是的，讓我盡力確保我能全部得到。如果我不知道，請回覆我，因為這是一個複合問題。首先，讓我從最後開始說，我們的願景是成為一家廣泛的傷口護理公司，A，我們預計不需要額外的銷售人員。這是第一個問題。

The second is all of the product areas, as I illustrated in that particular slide, they actually go with the treatment of these type of wounds. So while our RECELL salesperson is sitting there, they can get into wound preparation, they can get into scaffolding, they can get into a sophisticated dressing like PermeaDerm. That's all on the same patient, same doctor at the same time, same wound. So that is a pure leverage and portfolio expansion around our existing treatment sites and physician sites. So it's synergistic to be sure.

第二個是所有產品領域，正如我在那張投影片中所展示的那樣，它們實際上都與這類傷口的治療有關。因此，當我們的 RECELL 銷售人員坐在那裡時，他們可以進行傷口準備，可以進行鷹架，可以進行像 PermeaDerm 這樣的複雜敷料。這些都是發生在同一個病人、同一個醫生、同一時間、同一個傷口上的情況。因此，這是圍繞我們現有治療站點和醫生站點的純粹槓桿和投資組合擴張。因此可以肯定，它們具有協同作用。

In terms of the ramp in the back half, let me comment on a few things. We don't -- we haven't broken it out in terms of how we're giving guidance yet. We will as we gain a little bit more experience. But suffice to say that you can intuit that there's going to be a meaningful contribution from PermeaDerm, first of all.

關於後半部的坡道，讓我評論幾點。我們還沒有——我們還沒有就如何提供指導進行詳細說明。隨著我們獲得更多經驗，我們將會這麼做。但首先，您可以直觀地知道 PermeaDerm 將做出有意義的貢獻。

Second of all, RECELL GO, and this is again, it was 180 days as of May 30, so we are actually -- have built inventory and are prepared for a positive news, and that has a lot of energy for the second half of the year because of two things. Let me differentiate them for you.

其次，RECELL GO，截至 5 月 30 日已經是 180 天了，所以我們實際上已經建立了庫存，並準備好迎接積極的消息，而且由於兩件事，這為下半年帶來了很大的活力。讓我幫您區分它們。

In the burns world, it is often we use between -- it's often that between one and two RECELL kits are used per patient. So that means somewhere greater than 10% TBSA as much as 20%. And so they often have to use them in sequence. And that is a process, right? You take a biopsy. You process it in the manual method. And then, you spray it on. And then, you take another biopsy and go through the same process for the second kit.

在燒傷治療中，我們通常會為每位患者使用一到兩個 RECELL 套件。所以這意味著 TBSA 大於 10% 甚至高達 20%。因此他們經常必須按順序使用它們。這是一個過程，對吧？你進行活檢。您以手動方式處理它。然後，你將其噴灑上。然後，您再進行一次活檢，並對第二個套件重複相同的過程。

Particularly for the burns surgeons, they are imagining bring to RECELL GO instruments into the room and processing simultaneously and cutting OR time by a material amount. So they're really quite motivated by the prospect of RECELL GO.

特別是對於燒傷外科醫生來說，他們想像著將 RECELL GO 儀器帶入房間並同時進行處理，從而大幅縮短手術室時間。所以他們對於 RECELL GO 的前景非常看好。

Secondly, what goes with that is also same benefit for full thickness because in burns case, they will use less manpower doing it because it takes a technician to assist the physician -- an extra technician or nurse to help the physician prepare the current version. You don't need that extra person in the case of RECELL GO. So it has a double effect. It helps in, as you can imagine, the burns making case shorter and less work from less people.

其次，全層燒傷也有同樣的好處，因為在燒傷病例中，他們將使用更少的人力來做這件事，因為需要技術人員協助醫生——額外的技術人員或護士來幫助醫生準備當前的版本。使用 RECELL GO 時您不需要額外的人員。因此它有雙重效果。正如您所想的，它有助於縮短案件審理時間，並減少人員工作量。

And also, in the full thickness, you don't need that extra technician and it decreases the training requirements really significantly. So we have an expectation that we get an upsurge of adoption as a consequence of it being simply easier to do. So that's what we're believing is going to happen.

而且，在完整厚度下，您不需要額外的技術人員，這大大降低了訓練要求。因此，我們期望由於這更容易實現，因此採用率會大幅上升。我們相信這會發生。

Did I get them all, right?

我全都拿到了嗎？

I think so. There was a lot of questions in there, Jim. Thank you for knocking them out.

我認為是這樣。這裡面有很多問題，吉姆。謝謝你把他們打倒了。

And then just lastly for me, and I'll hop back in queue, David, with the introduction of PermeaDerm, what are you expecting for your gross margins? I would imagine there's a little bit of pressure on the gross margin line in the back half of the year as PermeaDerm ramps up?

最後，對我來說，我會回到隊列中，大衛，隨著 PermeaDerm 的推出，您對毛利率有何預期？我可以想像，隨著 PermeaDerm 的成長，下半年的毛利率會面臨一點壓力嗎？

Yeah, as you know, the agreement calls were 50% gross margin for us when we sell. So it's going to be contributing less than our core business but there has to be a degradation of our gross margin over the last half of the year. And as I indicated with Brooks, we're going to be giving more guidance around what that revenue looks like from PermeaDerm for the second half of the year in August on our second-quarter earnings call.

是的，如您所知，當我們銷售時，協議電話的毛利率為 50%。因此，它的貢獻將低於我們的核心業務，但今年下半年我們的毛利率必定會下降。正如我和布魯克斯所說，我們將在 8 月的第二季財報電話會議上就 PermeaDerm 下半年的收入情況提供更多指導。

Matthew O'Brien, Piper Sandler.

馬修·奧布萊恩、派珀·桑德勒。

Thanks for taking the questions. I guess, the guide for Q2 is predicated on you guys getting back to 15 new center adds per month versus kind of 7 is what you did in Q1. Are you seeing that so far in April and maybe early days of May?

感謝您回答這些問題。我想，第二季的指導方針是基於你們每月增加 15 個新中心，而第一季是每月增加 7 個左右。您是否在四月或五月初看到了這種現象？

Could you repeat -- are you talking about the new additions of -- what we have is the -- without disclosing month by month, in the quarter, we have specific dates for all 46 of those expected approvals of when they meet and when we expect them to be approved. So that's a (multiple speakers)

您能否重複一下——您說的是新增的內容嗎——我們有——沒有逐月披露，但在本季度，我們對所有 46 個預期批准都有具體的日期，包括它們何時開會以及我們預計它們何時獲得批准。所以這是一個（多位發言者）

(multiple speakers) what you expected? Were you expecting all 22 or were you expecting 45 and got half?

（多位發言者）您期望什麼？您期望的是全部 22 個，還是期望是 45 個，但結果只有一半？

Well, we wanted 40 -- we've wanted more than 22. 22 is what we got. But they didn't come to committee. So that was a different problem. It wasn't a turned down where we went to committee and got turned down. So we've been rarely turned down. So these 46, we expect to happen because we have (multiple speakers)

好吧，我們想要 40 個——我們想要的不只 22 個。但他們沒有參加委員會。所以這是一個不同的問題。我們去委員會提出申請後並沒有被拒絕。因此我們很少被拒絕。因此，我們預計這 46 個會發生，因為我們有（多位發言者）

Okay. And then the back half ramp is just -- it's just big. I don't know how else to say it. What is it that gives you guys the confidence I don't know if PermeaDerm maybe get all $6 million in the back half, but it should -- even in the low end of the range is a massive ramp and there's going to be skepticism about your ability to get there. So just how can you help just calm some of those fears that you can't get there? And then I do have one more quick question for David.

好的。然後後半部的坡道就——它很大。我不知道還能怎樣表達。是什麼讓你們有信心？ 我不知道 PermeaDerm 是否可能在下半年獲得全部 600 萬美元，但它應該——即使在該範圍的低端也是一個巨大的進步，而且人們對你們實現這一目標的能力表示懷疑。那麼你要如何幫助平息那些無法實現的恐懼呢？然後我還有一個快速問題要問大衛。

Sure. Well, first of all, PermeaDerm plays a role, but RECELL GO plays a bigger role. We'll get -- RECELL GO is going to transform our business model very fundamentally. RECELL as it sits today, you have to constantly train and always be present almost from most cases. So that hurts you in utilization and burn accounts relative to having RECELL GO, I mean, and it, so to speak, slows down the adoption in full thickness. Both of those will get significant energy from having the work being done in the process of creating the RECELL spray on skin in a way that doesn't require person. So that will make a big difference.

當然。首先，PermeaDerm 發揮了一定作用，但 RECELL GO 發揮的作用更大。我們會得到——RECELL GO 將從根本上改變我們的商業模式。就目前的 RECELL 而言，您必須不斷進行訓練，並且幾乎在大多數情況下始終在場。因此，與使用 RECELL GO 相比，這會損害您的利用率並燒毀帳戶，我的意思是，它可以減緩全面採用的速度。這兩種方法都可以從在無需人工的情況下製造 RECELL 噴霧劑的過程中獲得大量能量。這會產生很大的影響。

The market's quite huge. So getting a product that is easier to learn, easier to use will make it will make a ton of difference.

這個市場相當巨大。因此，獲得一種更容易學習、更容易使用的產品將會產生很大的不同。

Okay. And that launches late Q3, is that right?

好的。而且它將在第三季末推出，對嗎？

No, it is -- we expect approval May 30, and we have inventory.

不，是的——我們預計 5 月 30 日獲得批准，而且我們有庫存。

Okay. Okay. So second half should benefit right away. Okay. And then, David, the commentary on SG&A as all understandable with the sales force that you had in Q2, but there was a big sequential step-up from Q4 to Q1 on the sales and marketing side, what was that? And then, do we expect spending in this range going forward? And if that's the case, I mean, why would you feel comfortable that the cash you have on hand is enough to get you through to profitability? Thanks.

好的。好的。因此下半場應該會立即受益。好的。然後，大衛，對於銷售、一般及行政開支的評論，由於你們在第二季度擁有銷售團隊，所以都是可以理解的，但是從第四季度到第一季度，銷售和營銷方面有一個很大的連續增長，那是什麼？那麼，我們是否預期未來支出會在這個範圍內？如果事實確實如此，那麼為什麼您會覺得您手邊的現金足以讓您獲利呢？謝謝。

Yes, thanks for the question. I'm going to answer the last one first because I was thinking about this also, as you were asking, Jim, about the last half of the year. The ramp is significant for the last half of the year. When we achieve that through the initiatives that we've talked about, that is going to start to get to a point where our cash burn is not very significant with that ramp-up in revenue.

是的，謝謝你的提問。我將首先回答最後一個問題，因為正如你問的那樣，吉姆，關於今年上半年的情況，我也在考慮這個問題。對今年下半年來說，這項成長意義重大。當我們透過所討論的措施實現這一目標時，我們的現金消耗將不會隨著收入的增加而大幅增加。

And so we believe in the lower end of our guidance. And when we achieve that, we'll be heading into 2025 with a significant run rate for revenue. And so we've talked about getting to a cash flow breakeven by the middle of next year. And as we enter 2025 with the revenue, we believe we're going to be achieving that cash flow breakeven GAAP profitability as it can be done.

因此，我們相信我們的指導下限。當我們實現這一目標時，我們將在 2025 年實現可觀的收入。因此，我們討論了在明年年中實現現金流收支平衡。隨著我們進入 2025 年，我們相信我們將盡可能實現現金流損益平衡的 GAAP 獲利能力。

You ask the question about our expenses going forward, SG&A, I think we have indicated that we increased our sales force as of the end of Q3 -- our Q1, I'm sorry. And so as far as the sales and marketing expense, it will step up from Q1. SG& -- or the other side of it, G&A is going to stay relatively flat, if not decrease. And R&D expenses, we don't see any major step up in that also. So I think I've covered all three of them. We do see again sales and marketing increasing because we'll have a full quarter of the expanded sales team that we underwent in Q1.

您問到我們未來的費用，銷售、一般及行政開支，我想我們已經表明，截至第三季末（也就是第一季末），我們增加了銷售人員，對不起。就銷售和行銷費用而言，它將從第一季開始增加。另一方面，銷售費用與行政費用將保持相對平穩，甚至減少。而研發費用方面，我們也沒有看到有什麼重大的增加。我認為我已經講完了這三個內容。我們確實再次看到銷售和行銷的成長，因為我們的銷售團隊將比第一季擴大一整季。

Chris Kallos, MST Access.

克里斯·卡洛斯（Chris Kallos），MST Access。

Thank you for taking my question. Jim, I just wanted to ask about a little more color around the international expansion, in particular the CMAC and your plans of launching the products into Europe?

感謝您回答我的問題。吉姆，我只是想問一下有關國際擴張的更多信息，特別是 CMAC 和您將產品推向歐洲的計劃？

Yes. Well, first of all, one of the -- as we've been evaluating are different distributor choices, one of the things, of course, as we've done some tests -- not test, the wrong word. We've done some cases with some distributors that we have not signed as a way for them to get familiar with the technology. And of course, what's happening is we're about to head into summertime, which is not the perfect time to launch into Europe. And then, it will coincide with the readiness of RECELL GO forward with -- under the MDR sometime in September, October.

是的。嗯，首先，我們一直在評估不同的經銷商選擇，當然，我們做了一些測試，不是測試，用詞不當。我們與一些未簽約的經銷商合作過一些案例，以便他們熟悉這項技術。當然，我們即將進入夏季，這不是前往歐洲的最佳時機。然後，它將與 RECELL GO 在 9 月或 10 月的某個時候根據 MDR 進行的準備工作相吻合。

One reason we've given a broad window is, clearly, a couple of the distributors we're talking about have identified that they prefer to launch with RECELL GO, then switch after two or three months. So that's one of the factors, but our goal is to get that done this year. And the same is true -- and you may know, Australia recognizes the MDR this year, so we'll be doing the same with Australia.

我們給出這麼寬泛的時間範圍的一個原因顯然是，我們正在談論的幾個分銷商已經確定他們更願意先推出 RECELL GO，然後在兩三個月後再轉換。這是其中一個因素，但我們的目標是今年完成。事實也是如此——您可能知道，澳洲今年承認了 MDR，因此我們也將對澳洲採取同樣的措施。

Great. And I also understand that the disappointing quarter was largely due to a lower burn rate in January, if I heard correctly. What was the reason to that? And has that now normalized? You're comfortable that's going to return to historical norms going forward.

偉大的。如果我沒聽錯的話，我還了解到，令人失望的季度業績主要是因為 1 月份的資金消耗率較低。那是什麼原因呢？現在這種情況已經正常化了嗎？您很放心，未來這將回歸到歷史常態。

It seems so, Chris. It seems like that is -- the only one we had facts on, if you recall was January. February, March, we don't have facts on, but January by itself was down enough that you see it right away. We're not seeing that same effect currently.

看起來是這樣，克里斯。看起來好像是——如果你還記得的話，我們唯一掌握事實的月份是 1 月。我們沒有二月、三月的相關事實，但一月份的銷量下降幅度已經足夠大，你可以馬上看到。目前我們還沒有看到同樣的效果。

Great. And I guess I'm just echoing everything. The other questions have come around the aggressive growth rate in the back half of the year. How much of that is going to be driven by the traditional burns accounts versus the new accounts in for skin-thickness defects?

偉大的。我想我只是在重複這一切。其它問題則圍繞著今年下半年的強勁成長率。其中有多少是由傳統的燒傷帳戶驅動，有多少是由新的皮膚厚度缺損帳戶驅動？

Well, good through this year, burns will remain the bigger part of our business. The faster growth part of it will be full thickness. But through this year, burns is going to grow still and still be the majority, more than half our sales, even in the fourth quarter. But the fastest-growing part is the biggest market, which is full thickness.

嗯，今年，燒傷仍將是我們業務的重心。生長較快的部分將達到全層。但今年，即使在第四季度，燒錢業務仍將保持成長，仍將佔據主導地位，占我們銷售額的一半以上。但成長最快的部分是最大的市場，也就是全厚度市場。

Madeleine Williams, Wilsons.

瑪德琳威廉斯，威爾森一家。

Hi, Jim and David. I'm just wanting to understand in regards to -- thanks for putting up the -- a little bit more color to the VAC submissions. In regards to the rejections, I just wondered if the hospitals or trauma centers that have rejected RECELL, if they have certain characteristics or you can notice certain trend in those that do reject and whether or not you can kind of get color on the approvals, going forward?

嗨，吉姆和大衛。我只是想了解有關 — — 感謝您提供 — — VAC 提交的更多詳細資訊。關於被拒絕的問題，我只是想知道，那些拒絕 RECELL 的醫院或創傷中心是否具有某些特點，或者您是否能注意到那些拒絕的醫院或創傷中心的某些趨勢，以及您是否能在未來獲得批准方面得到一些信息？

Madeleine, thanks for the question. There is -- it's 8 out of almost 178 submissions, and they didn't seem to fit any pattern to be candid. There were reasons here and there. Sometimes it was related to how they perceive their patient load. That was a case, for example. Another case was whether they thought -- for the indications that particular trauma center saw, whether it was going to be economic or not for them to use it. But they were all -- there was no trend or pattern because it's a very small sample to try and detect a pattern, unless it was for all the same reason, which they weren't.

瑪德琳，謝謝你的提問。有——在近 178 份提交中，只有 8 份是這樣的，而且它們似乎不符合任何模式。其中有各種各樣的原因。有時這與他們如何看待病人的負擔有關。例如那是一個案例。另一種情況是，他們是否認為——對於特定創傷中心所看到的跡象，他們使用它是否具有經濟性。但是它們全部——沒有趨勢或模式，因為這是一個非常小的樣本，試圖檢測一種模式，除非它們都是出於相同的原因，但事實並非如此。

Okay, thanks. And I guess more broadly, just thinking about do you have in mind internally the rate at which you think rejections will continue to occur, assuming that some certain centers will reject and whether or not that's included in how you're thinking about the forecast for the rest of the year?

好的，謝謝。我想更廣泛地說，想想您是否考慮過拒絕的持續發生率，假設某些中心會拒絕，以及這是否包含在您對今年剩餘時間的預測中？

Yes, we think they occur almost randomly, so they don't happen at a high rate. So we don't think the amount of rejections will have a material effect on our ability to reach our guidance.

是的，我們認為它們幾乎是隨機發生的，所以它們發生的頻率並不高。因此，我們認為拒絕的次數不會對我們實現指導目標的能力產生重大影響。

Hannah Mitchell, Bank of America.

美國銀行的漢娜·米切爾。

Hi, Jim and David. This is Rachel on for Lyanne Harrison. Thanks for taking my question. Just wondering if you can provide any more color on the BARDA national preparedness arrangement, including what quantities BARDA might be considering and over what time frame? Thank you.

嗨，吉姆和大衛。這是 Rachel 為 Lyanne Harrison 主持的節目。感謝您回答我的問題。只是想知道您是否可以提供更多有關 BARDA 國家防範安排的詳細信息，包括 BARDA 可能考慮的數量以及時間範圍？謝謝。

Yes. So we've entered into a -- or in the process -- let me speak all over. Our fundamental BARDA agreement is over. It's expired. What we're entering into is a first call on -- an amount of inventory that they would get on first call up to a certain maximum, which we haven't -- we have made public, right, and it's 1,000 units. And so the -- in the event of a national disaster, BRADA has a call to purchase 1,000 units and as a first priority. So we're managing our own inventory. They don't own any of it, and this would only occur in the event of a national disaster where they needed to call upon that inventory.

是的。因此，我們已經進入了一個 — — 或者說在這個過程中 — — 讓我全面地講一下。我們的基本 BARDA 協議已經結束。已過期。我們達成的是首次認購協議——他們在首次認購時可以獲得的庫存數量不得超過某個最大值，我們還沒有公佈這個最大值，對吧，我們已經公佈了，現在是 1,000 個單位。因此，如果發生國家災難，BRADA 將優先購買 1,000 台。所以我們管理自己的庫存。他們並不擁有任何東西，只有在發生國家災難時才需要動用這些庫存。

And thank you. And I'm showing no further questions. I would now like to turn the call back over to Jim Corbett for closing remarks.

謝謝你。我沒有其他問題。現在我想將電話轉回給吉姆·科貝特 (Jim Corbett) 做結束語。

I'd like to thank all of you for listening and getting the latest update from AVITA. We look forward to talking with you again next quarter. And thank you again. Bye-bye.

我感謝大家的收聽並獲取 AVITA 的最新消息。我們期待下個季度再次與您交談。再次感謝您。再見。

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。您現在可以斷開連線。