Vericel Corp (VCEL) 2022 Q4 法說會逐字稿

完整原文

使用警語:中文譯文來源為 Google 翻譯,僅供參考,實際內容請以英文原文為主

  • Operator

    Operator

  • Ladies and gentlemen, thank you for standing by. Welcome to Vericel's Fourth Quarter 2022 Conference, call. (Operator Instructions) I would also like to remind you that this call is being recorded for replay. (Operator Instructions)

    女士們,先生們,謝謝你們的支持。歡迎來到 Vericel 的 2022 年第四季度會議,請致電。 (操作員說明)我還想提醒您,正在錄製此通話以進行重播。 (操作員說明)

  • I will now turn the conference over to Eric Burns, Vericel's Head of Financial Planning and Analysis and Investor Relations.

    我現在將會議轉交給 Vericel 的財務規劃和分析以及投資者關係主管 Eric Burns。

  • Eric Burns - Executive Director of Financial Planning and Analysis & IR

    Eric Burns - Executive Director of Financial Planning and Analysis & IR

  • Thank you, operator, and good morning, everyone. Welcome to Vericel's Fourth Quarter chosen to conference call to discuss our financial results and business highlights.

    謝謝接線員,大家早上好。歡迎來到 Vericel 的第四季度,選擇召開電話會議來討論我們的財務業績和業務亮點。

  • Before we begin, let me remind you on today's call, we will be making forward-looking statements covered under the Private Securities Litigation Reform Act of 1995. These statements may involve risks and uncertainties that could cause actual results to differ materially from expectations and are described more fully in our filings with the SEC, which are available on our website. In addition, all forward-looking statements represent our views only as of today and should not be relied upon as representing our views as of any subsequent date.

    在我們開始之前,讓我在今天的電話會議上提醒您,我們將根據 1995 年《私人證券訴訟改革法案》做出前瞻性陳述。這些陳述可能涉及可能導致實際結果與預期存在重大差異的風險和不確定性,並且在我們向美國證券交易委員會提交的文件中有更全面的描述,這些文件可在我們的網站上找到。此外,所有前瞻性陳述僅代表我們截至今天的觀點,不應被視為代表我們在任何後續日期的觀點。

  • Please note that a copy of our fourth quarter financial results press release is available in the Investor Relations section of our website. We also have a short presentation found on today's call that can be do directly on the webcast or accessed on our website.

    請注意,我們網站的投資者關係部分提供了我們第四季度財務業績新聞稿的副本。我們還在今天的電話會議上找到了一個簡短的演示文稿,可以直接在網絡廣播中進行或在我們的網站上訪問。

  • I'm joined on this call by Vericel's President and Chief Executive Officer, Nick Colangelo; and our Chief Financial Officer, Joe Mara. I will now turn the call over to Nick.

    Vericel 的總裁兼首席執行官 Nick Colangelo 和我一起參加了這次電話會議;以及我們的首席財務官 Joe Mara。我現在將電話轉給尼克。

  • Dominick C. Colangelo - CEO, President & Director

    Dominick C. Colangelo - CEO, President & Director

  • Thank you, Eric. And good morning, everyone. I'll begin today's call by discussing financial and business highlights for the fourth quarter and full year 2022; current trends for MACI, which have been very positive to start the year; our NexoBrid commercial launch activities; and our overall outlook for 2023, a year in which we expect total revenue growth to accelerate and continued strong profitability for the company. Joe will then provide a more detailed update on our financial performance in 2022 and financial guidance for 2023 before opening the call to Q&A.

    謝謝你,埃里克。大家早上好。我將通過討論第四季度和 2022 年全年的財務和業務亮點來開始今天的電話會議; MACI 的當前趨勢,今年開始時非常積極;我們的 NexoBrid 商業發布活動;以及我們對 2023 年的總體展望,我們預計這一年總收入增長將加速,公司的盈利能力將繼續保持強勁。然後,Joe 將更詳細地介紹我們 2022 年的財務業績和 2023 年的財務指導,然後再開始問答環節。

  • The company delivered strong financial and business results to close the year as we generated record quarterly revenue; delivered our 10th straight quarter of profitability and positive operating cash flow; and achieved significant development milestones, including an accelerated regulatory pathway for the arthroscopic MACI program and FDA approval of NexoBrid, which we believe will enable the company to build a second high-growth commercial franchise.

    由於我們創造了創紀錄的季度收入,公司在年底取得了強勁的財務和業務業績;連續第 10 個季度實現盈利和正運營現金流;並取得了重要的發展里程碑,包括加速關節鏡 MACI 計劃的監管途徑和 FDA 批准 NexoBrid ,我們相信這將使公司能夠建立第二個高增長的商業特許經營權。

  • For the full year, total revenue was more than $164 million, with MACI revenue growing 18% to $132 million. We continued to deliver strong profitability and cash flow as we generated nearly $25 million of adjusted EBITDA and $18 million of operating cash flow, ending the year with $140 million in cash and investments and no debt. We also generated record total revenue of nearly $53 million in the fourth quarter as well as gross margin of 73% and adjusted EBITDA margin of nearly 30%, both of which increased versus the prior year, and approximately $6 million in net income for the quarter, which increased more than 30% compared to 2021.

    全年總收入超過 1.64 億美元,其中 MACI 收入增長 18% 至 1.32 億美元。我們繼續提供強勁的盈利能力和現金流,因為我們產生了近 2500 萬美元的調整後 EBITDA 和 1800 萬美元的運營現金流,年底現金和投資達到 1.4 億美元,沒有債務。我們還在第四季度創造了近 5300 萬美元的創紀錄總收入,以及 73% 的毛利率和近 30% 的調整後 EBITDA 利潤率,兩者均比上年有所增長,本季度的淨收入約為 600 萬美元,與 2021 年相比增長了 30% 以上。

  • Our strong fourth quarter results were driven by record quarterly MACI revenue of over $46 million, which came in at the high end of our guidance range, represented 24% growth over the fourth quarter of 2021 and approximately 50% sequential growth over the third quarter of 2022. The strong revenue growth was driven by strengthening key growth drivers for MACI.

    我們強勁的第四季度業績是由創紀錄的季度 MACI 收入超過 4600 萬美元推動的,該收入處於我們指導範圍的高端,比 2021 年第四季度增長 24%,比 2021 年第三季度環比增長約 50% 2022. MACI 主要增長動力的增強推動了收入的強勁增長。

  • Surgeon adoption continued to grow as we finished the year with approximately 2,000 surgeons taking biopsies in 2022, an increase of approximately 10% from 2021. We also had continued growth in MACI biopsies in the fourth quarter and stabilization in the biopsy conversion rate to close out the year. As I'll discuss in a moment, the positive trends that we saw in the fourth quarter have continued into the first quarter as the operating environment continues to improve.

    外科醫生的採用率繼續增長,因為我們在 2022 年完成了約 2,000 名外科醫生的活檢,比 2021 年增加了約 10%。我們在第四季度的 MACI 活檢也持續增長,並且活檢轉換率穩定以結束那一年。正如我稍後將討論的那樣,隨著經營環境的持續改善,我們在第四季度看到的積極趨勢一直延續到第一季度。

  • With respect to Epicel, fourth quarter and full year revenue was lower than anticipated as the incidence of large burns greater than 30% of total body surface area declined to pre-2021 levels. Notwithstanding this dynamic, we continue to see broad burn center engagement as we had a record number of burn centers taking biopsies in the fourth quarter and the full year and a similar number of burn centers grafting patients during the year.

    關於 Epicel,第四季度和全年收入低於預期,因為大面積燒傷的發生率超過全身表面積的 30%,降至 2021 年前的水平。儘管存在這種動態,但我們繼續看到燒傷中心廣泛參與,因為我們在第四季度和全年進行活組織檢查的燒傷中心數量創下歷史新高,並且在這一年中有類似數量的燒傷中心移植患者。

  • While the breadth of customer engagement generated solid Epicel biopsy activity, the proportion of biopsy patients going on to surgery was lower in 2022 and particularly in the fourth quarter due mainly to patient health-related issues. We also had fewer Epicel grafts per patient in 2022, which has grown significantly in 2021. And there were some organizational changes at our largest customer, which impacted patient referral patterns and had a significant impact on patient volume at that center. Despite these dynamics, which led to the variability we often see with Epicel, we believe that our strong engagement with leading burn centers and our expanded customer base positions us very well to drive NexoBrid uptake upon launch.

    雖然廣泛的客戶參與產生了可靠的 Epicel 活檢活動,但在 2022 年進行手術的活檢患者比例較低,尤其是在第四季度,這主要是由於與患者健康相關的問題。我們在 2022 年每位患者的 Epicel 移植物也有所減少,但在 2021 年有了顯著增長。我們最大的客戶發生了一些組織變化,這影響了患者轉診模式,對該中心的患者數量產生了重大影響。儘管存在這些動態,導致我們經常看到 Epicel 的可變性,但我們相信,我們與領先的燒傷中心的密切合作以及我們擴大的客戶群使我們能夠很好地推動 NexoBrid 在推出時的採用。

  • In addition to generating strong financial results in the fourth quarter, we also made significant progress advancing our pipeline. As we announced last month, following our Type C meeting with the FDA in December, we're planning to initiate a human factors validation study this year to support expanding the MACI label to include arthroscopic delivery of MACI for the treatment of cartilage defects in the knee. We now anticipate a potential launch of arthroscopic MACI in 2024, which is several years earlier than an additional clinical study was required.

    除了在第四季度取得強勁的財務業績外,我們還在推進產品線方面取得了重大進展。正如我們上個月宣布的那樣,在 12 月與 FDA 舉行 C 類會議之後,我們計劃今年啟動一項人為因素驗證研究,以支持擴大 MACI 標籤,以包括關節鏡下遞送 MACI 以治療軟骨缺損膝蓋。我們現在預計可能會在 2024 年推出關節鏡 MACI,這比需要進行額外的臨床研究要早幾年。

  • We believe that the arthroscopic delivery of MACI will be a very attractive option for patients and surgeons and could provide a substantial upside growth opportunity for MACI. Based on our initial market research, approximately 90% of respondents expressed interest in an arthroscopic delivery option for MACI, which provides an opportunity for additional surgeon adoption, given that a portion of the more than 10,000 surgeons that perform cartilage repair procedures in the U.S. each year, either primarily or exclusively, perform arthroscopic procedures and could now consider MACI as an option for their patients.

    我們相信 MACI 的關節鏡下遞送對於患者和外科醫生來說將是一個非常有吸引力的選擇,並且可以為 MACI 提供大量的上行增長機會。根據我們最初的市場研究,大約 90% 的受訪者表示對 MACI 的關節鏡下交付選項感興趣,這為更多的外科醫生採用提供了機會,因為在美國進行軟骨修復手術的 10,000 多名外科醫生中,有一部分人每個年,主要或專門進行關節鏡手術,現在可以考慮將 MACI 作為患者的一種選擇。

  • Arthroscopic MACI also offers the potential for increased utilization among current MACI users as approximately 90% of current users indicated that they would expect to increase MACI procedure volume if an arthroscopic option was available. To that end, the arthroscopic MACI instrument kit is designed to treat the most common defects in the MACI patient addressable market, which are 2 to 4 square centimeter defects on the femoral con dials. And MACI would be the only arthroscopically-administered restorative cartilage repair product to treat these defects, which we believe would allow us to achieve a greater share of those procedures.

    關節鏡 MACI 還提供了提高當前 MACI 用戶利用率的潛力,因為大約 90% 的當前用戶表示,如果可以使用關節鏡選項,他們希望增加 MACI 手術量。為此,關節鏡 MACI 儀器套件旨在治療 MACI 患者可尋址市場中最常見的缺陷,即股骨錶盤上 2 至 4 平方厘米的缺陷。 MACI 將是唯一一種通過關節鏡給藥的修復性軟骨修復產品來治療這些缺陷,我們相信這將使我們能夠在這些手術中取得更大的份額。

  • We're also in discussions with the FDA regarding our planned MACI clinical development program for the treatment of cartilage injuries in the ankle, which is the next largest market opportunity for MACI. We believe that a potential ankle indication with an estimated $1 billion addressable market could be a significant growth driver for MACI over the long term.

    我們還在與 FDA 討論我們計劃的 MACI 臨床開發計劃,用於治療腳踝軟骨損傷,這是 MACI 的下一個最大市場機會。我們認為,潛在的腳踝適應症估計有 10 億美元的可尋址市場,從長遠來看可能是 MACI 的重要增長動力。

  • Turning to our Burn Care franchise. The FDA approval of NexoBrid was a significant milestone for the company, and our commercial launch activities are progressing well. We've seen widespread interest and enthusiasm from burn surgeons and other health care providers for NexoBrid. And we're on track to meet or exceed our internal goals regarding burn center engagement ahead of commercial product availability, which is expected in the second quarter of this year.

    轉向我們的燒傷護理專營權。 FDA 批准 NexoBrid 對公司來說是一個重要的里程碑,我們的商業發布活動進展順利。我們已經看到燒傷外科醫生和其他醫療保健提供者對 NexoBrid 的廣泛興趣和熱情。我們有望在商業產品上市之前達到或超過我們關於燒傷中心參與的內部目標,預計將在今年第二季度上市。

  • The hiring of our NexoBrid sales team is nearly complete and training for burn surgeons began last month following approval. There are a number of high-profile burn conferences in the first part of the year, including the American Burn Association Annual Meeting, where we'll have a significant presence to support the launch of NexoBrid and where NexoBrid training conducted by leading burn surgeons will be included in pre-conference peer-to-peer educational sessions regarding the science of wound preparation and the science of wound closure.

    我們的 NexoBrid 銷售團隊的招聘工作接近完成,燒傷外科醫生的培訓在獲得批准後於上個月開始。今年上半年有許多備受矚目的燒傷會議,包括美國燒傷協會年會,我們將在會上大力支持 NexoBrid 的推出,領先的燒傷外科醫生將在會上進行 NexoBrid 培訓被包括在關於傷口準備科學和傷口閉合科學的會前同行教育會議中。

  • Given that NexoBrid will be dispensed through hospital pharmacies, gaining P&T committee approval for the use of NexoBrid in our largest -- or in our target burn centers is a high priority activity during the early launch phase. Based on the widespread interest in NexoBrid, we have surgeon champions at dozens of our target burn centers who will lead the process to gain P&T committee approval at their respective institutions. This process can take up to a few months, which should sync up well with the timing for NexoBrid commercial product availability in the second quarter.

    鑑於 NexoBrid 將通過醫院藥房配藥,獲得 P&T 委員會批准在我們最大的——或我們的目標燒傷中心使用 NexoBrid 是早期啟動階段的一項高度優先活動。基於對 NexoBrid 的廣泛興趣,我們在數十個目標燒傷中心擁有外科醫生冠軍,他們將領導這一過程,以獲得各自機構的 P&T 委員會批准。這個過程可能需要幾個月的時間,這應該與第二季度 NexoBrid 商業產品的上市時間同步。

  • Looking at the overall Burn Care franchise, the approval of NexoBrid in the U.S. significantly increases the addressable market for our Burn Care franchise to over $0.5 billion. While we expect that Epicel will return to growth over the coming years, we believe that NexoBrid will provide a more consistent and predictable revenue stream and help offset much of the Epicel revenue volatility. In addition, the incremental investment required for NexoBrid is relatively limited given our existing burn care commercial infrastructure and the overlap with Epicel, which should also benefit from a larger commercial footprint and higher share of voice in the market.

    從整個燒傷護理特許經營權來看,NexoBrid 在美國的批准顯著增加了我們燒傷護理特許經營權的潛在市場,超過 5 億美元。雖然我們預計 Epicel 將在未來幾年恢復增長,但我們相信 NexoBrid 將提供更加一致和可預測的收入流,並有助於抵消 Epicel 收入的大部分波動。此外,考慮到我們現有的燒傷護理商業基礎設施以及與 Epicel 的重疊, NexoBrid 所需的增量投資相對有限, Epicel 也應該受益於更大的商業足跡和更高的市場份額。

  • Finally, turning to guidance for 2023. We expect total revenue for the year to increase to approximately $100 million to $188 million and to generate continued strong profitability and operating cash flow. Joe will provide further details in a moment, but I wanted to touch on some of the key elements of our guidance as well as the current operating environment for MACI to start the year.

    最後,轉向 2023 年的指導。我們預計今年的總收入將增加到約 1 億美元至 1.88 億美元,並產生持續強勁的盈利能力和經營現金流。 Joe 稍後將提供更多詳細信息,但我想談談我們指南的一些關鍵要素以及 MACI 今年開始的當前運營環境。

  • As we announced this morning, we expect MACI revenue to be in the range of $152 million to $156 million for the year. The underlying framework for our initial MACI guidance is that full year revenue growth will be driven by continued growth in biopsy surgeons and higher net price per implant. At this point, our guidance for the year does not assume any sustained increase in other MACI key growth drivers of biopsies per surgeon or the biopsy conversion rate compared to 2022 levels, which would represent upside growth potential as we start the year. That being said, we're very encouraged not only by the strong fourth quarter for MACI, but also by a strong start of the year with positive trends that we saw in the fourth quarter continuing into the first quarter and the overall operating environment continuing to improve.

    正如我們今天上午宣布的那樣,我們預計 MACI 今年的收入將在 1.52 億美元至 1.56 億美元之間。我們最初的 MACI 指南的基本框架是,全年收入增長將由活檢外科醫生的持續增長和更高的每個植入物淨價推動。在這一點上,我們今年的指導意見不假設與 2022 年水平相比,每個外科醫生活檢的其他 MACI 關鍵增長驅動因素或活檢轉化率有任何持續增長,這將代表我們年初的上行增長潛力。話雖這麼說,我們不僅對 MACI 強勁的第四季度感到非常鼓舞,而且對今年開局強勁感到鼓舞,我們在第四季度看到的積極趨勢持續到第一季度,整體運營環境繼續提升。

  • At this point, we expect MACI growth for the first quarter to be approximately 20% versus last year, which would represent the third straight quarter of 20-plus percent year-over-year growth as MACI resumes its high-growth profile. More broadly, we believe that MACI is very well-positioned for another strong year of growth in 2023, and we expect that the launch of arthroscopic MACI in 2024 will drive even broader surgery adoption and further growth acceleration next year.

    在這一點上,我們預計 MACI 第一季度的增長率將比去年同期增長約 20%,隨著 MACI 恢復其高增長態勢,這將是連續第三個季度實現 20% 以上的同比增長。更廣泛地說,我們認為 MACI 為 2023 年又一個強勁增長做好了準備,我們預計 2024 年關節鏡 MACI 的推出將推動更廣泛的手術採用和明年的進一步增長加速。

  • Importantly, based on our 2023 full year guidance, our sales rep productivity will meet or surpass our historical high of $2 million per rep achieved prior to our last sales force expansion in 2020, and we would expect to begin to significantly exceed that level in 2024 and beyond.

    重要的是,根據我們的 2023 年全年指導,我們的銷售代表生產力將達到或超過我們在 2020 年上一次銷售人員擴張之前達到的歷史最高水平 200 萬美元,我們預計將在 2024 年開始顯著超過該水平超越。

  • With respect to the Burn Care franchise, we expect total burn care revenue of $28 million to $32 million with growth versus our fourth quarter annualized run rate for Epicel of $24 million, driven primarily by the launch of NexoBrid. We believe that the launch of NexoBrid, which has the potential to become the standard-of-care and (inaudible) removal and take a very meaningful share of its $300 million addressable market in the U.S., will enable the company to build a second high-growth franchise in the burn care market.

    關於燒傷護理特許經營權,我們預計燒傷護理總收入將達到 2800 萬至 3200 萬美元,而我們第四季度 Epicel 的年化運行率為 2400 萬美元,這主要是由 NexoBrid 的推出推動的。我們相信,NexoBrid 的推出有可能成為標準護理和(聽不清)去除,並在其 3 億美元的美國潛在市場中佔據非常重要的份額,這將使該公司能夠建立第二個高點- 燒傷護理市場的增長專營權。

  • I'll now turn the call over to Joe to discuss our fourth quarter and full year financial results as well as our financial guidance for 2023.

    我現在將電話轉給喬,討論我們的第四季度和全年財務業績以及我們 2023 年的財務指導。

  • Joseph Anthony Mara - CFO & Treasurer

    Joseph Anthony Mara - CFO & Treasurer

  • Thanks, Nick. And good morning, everyone. Starting with the income statement. Total net revenue for the full year was $164.4 million, driven by strong MACI results in the fourth quarter. Total company revenue in the fourth quarter was $52.7 million. MACI revenue of $132 million for the full year was at the high end of our guidance range, growing 18% versus the prior year.

    謝謝,尼克。大家早上好。從損益表開始。受第四季度強勁的 MACI 結果推動,全年淨收入總額為 1.644 億美元。第四季度公司總收入為 5270 萬美元。 MACI 全年收入為 1.32 億美元,處於我們指導範圍的高端,比上一年增長 18%。

  • For Q4, MACI revenue was $46.3 million and grew 24% versus the prior year and approximately 50% versus the third quarter as we continued our momentum in the MACI business with two very strong quarters to close out the year. MACI growth in 2022 was driven by continued strong surgeon and biopsy growth as well as a higher price and, importantly, the conversion rate for MACI stabilized in the second half of the year.

    第四季度,MACI 收入為 4630 萬美元,與去年同期相比增長 24%,與第三季度相比增長約 50%,因為我們在 MACI 業務中繼續保持強勁勢頭,兩個非常強勁的季度結束了今年。 2022 年 MACI 的增長是由持續強勁的外科醫生和活檢增長以及更高的價格推動的,重要的是,MACI 的轉化率在下半年趨於穩定。

  • Total Burn Care revenue for the year was $32.4 million, consisting of $31.7 million of Epicel revenue and $0.7 million of revenue related to the procurement of NexoBrid by BARDA for emergency response preparedness. Epicel revenue in the fourth quarter was $6.3 million.

    本年度燒傷護理總收入為 3240 萬美元,其中包括 3170 萬美元的 Epicel 收入和 70 萬美元與 BARDA 為應急準備採購 NexoBrid 相關的收入。 Epicel 第四季度的收入為 630 萬美元。

  • Gross profit for the quarter was $38.2 million or 73% of net revenue, an increase compared to 72% for the fourth quarter 2021. For the full year, gross profit was approximately $110 million or 67% of gross revenue, which was in line with the prior year gross margin and higher than our full year guidance in the mid-60% range.

    本季度毛利為 3820 萬美元,占淨收入的 73%,高於 2021 年第四季度的 72%。全年毛利約為 1.1 億美元,佔總收入的 67%,與前一年的毛利率高於我們在 60% 中間範圍內的全年指導。

  • Total operating expenses for the quarter were $32.2 million compared to $29.9 million for the same period in 2021. And for the full year, our operating expenses were $126.8 million compared to $113.9 million last year. The increase in operating expenses in 2022 was primarily due to an increase in headcount and higher sales and marketing expenses.

    本季度的總運營費用為 3220 萬美元,而 2021 年同期為 2990 萬美元。全年的運營費用為 1.268 億美元,而去年同期為 1.139 億美元。 2022 年運營費用的增加主要是由於員工人數增加以及銷售和營銷費用增加。

  • Net income for the quarter was $5.9 million or $0.12 per share compared to net income of $4.5 million or $0.09 per share for the fourth quarter of 2021, an increase of more than 30% versus the prior year.

    本季度淨收入為 590 萬美元或每股 0.12 美元,而 2021 年第四季度的淨收入為 450 萬美元或每股 0.09 美元,較上年增長 30% 以上。

  • Non-GAAP adjusted EBITDA for the quarter was $14.9 million or 28% of net revenue, an increase versus the 27% in 2021. And importantly, this represents our 10th consecutive quarter that we've generated positive adjusted EBITDA. For the full year, adjusted EBITDA was $24.2 million, similar to the $29.5 million we generated in 2021 despite lower Epicel revenue. The company has now generated over $50 million of adjusted EBITDA over the last 2 years and over $90 million over the last 4 years as we continue to grow our top line revenue, expand our pipeline and position the company for multiple product launches, while maintaining a very strong financial profile.

    本季度非 GAAP 調整後 EBITDA 為 1490 萬美元,占淨收入的 28%,比 2021 年的 27% 有所增長。重要的是,這是我們連續第 10 個季度產生正調整後 EBITDA。全年,調整後的 EBITDA 為 2420 萬美元,與我們在 2021 年產生的 2950 萬美元相似,儘管 Epicel 收入較低。隨著我們繼續增加我們的收入、擴大我們的產品線並為公司的多個產品發布定位,同時保持非常強大的財務狀況。

  • Finally, we generated $7 million of operating cash flow in the quarter and $17.7 million for the full year. We ended the year with approximately $140 million in cash and investments and no debt.

    最後,我們在本季度產生了 700 萬美元的運營現金流,全年產生了 1770 萬美元。到年底,我們擁有大約 1.4 億美元的現金和投資,並且沒有債務。

  • Transitioning to our financial guidance for 2023. We expect total revenue of $180 million to $188 million for the full year. We expect MACI revenue to be in the range of $152 million to $156 million, with growth in the mid- to high teens percentage range for the full year.

    過渡到我們 2023 年的財務指南。我們預計全年總收入為 1.8 億美元至 1.88 億美元。我們預計 MACI 的收入將在 1.52 億美元至 1.56 億美元之間,全年的增長率在中高十幾歲的百分比範圍內。

  • As Nick referenced, first quarter trends for MACI have been encouraging, driven by strength in both biopsies and implants, and we anticipate another strong quarter with growth of approximately 20% versus the first quarter of 2021. In terms of MACI's seasonality or mix of business by quarter, we would generally expect a similar percentage of full year revenue by quarter as we saw in 2022.

    正如 Nick 所提到的,在活組織檢查和植入物的強勁推動下,MACI 第一季度的趨勢令人鼓舞,我們預計該季度將是另一個強勁的季度,與 2021 年第一季度相比增長約 20%。就 MACI 的季節性或業務組合而言按季度劃分,我們通常預計按季度計算的全年收入百分比與 2022 年相似。

  • Moving to the Burn Care franchise. We expect full year Burn Care revenue, which includes both Epicel and NexoBrid revenue to be approximately $28 million to $32 million. This full year revenue range implies growth for the Burn Care franchise versus our commercial revenue run rate from Q4 of approximately $24 million.

    轉向燒傷護理專營權。我們預計全年燒傷護理收入(包括 Epicel 和 NexoBrid 收入)約為 2800 萬至 3200 萬美元。這一全年收入範圍意味著燒傷護理特許經營權的增長,而我們從第四季度開始的商業收入運行率約為 2400 萬美元。

  • In terms of NexoBrid revenue and uptake during the year, assuming commercial product availability in the second quarter, we would anticipate some modest stocking revenue in Q2, with the vast majority of NexoBrid revenue occurring in the second half of the year. As Nick mentioned, we expect NexoBrid to take a significant share of the market over time. In the near term, we would also expect NexoBrid to be an important driver of our burn care growth this year with meaningful revenue during the second half of the year, although it is difficult to predict the exact uptake in quarterly cadence of revenue during its launch year.

    就年內 NexoBrid 的收入和使用率而言,假設第二季度有商業產品上市,我們預計第二季度會有一些適度的庫存收入,其中絕大部分 NexoBrid 收入發生在下半年。正如 Nick 所提到的,我們預計 NexoBrid 將隨著時間的推移佔據相當大的市場份額。在短期內,我們還預計 NexoBrid 將成為我們今年燒傷護理增長的重要推動力,並在今年下半年帶來可觀的收入,儘管很難預測其推出期間收入的季度節奏的確切增長年。

  • For Epicel, quarterly revenues remain very difficult to predict due to the nature of the product and the volatility across quarters. Although for the first quarter based on trends to date, we would anticipate revenue to be roughly in line with the fourth quarter run rate of approximately $6 million.

    對於 Epicel,由於產品的性質和季度間的波動性,季度收入仍然很難預測。儘管根據迄今為止的趨勢來看第一季度,我們預計收入將大致與第四季度約 600 萬美元的運行率一致。

  • Moving down the P&L. We expect an improvement in gross margin compared to 2022, with gross margin expected to be in the high 60% range, adjusted EBITDA in the mid-teens percentage range and full year operating expenses to be approximately $140 million. Finally, we would also anticipate an increase in capital investment for the build-out of our new state-of-the-art cell therapy manufacturing facility and corporate headquarters as the project continues to move forward with our share of construction costs in the $30 million to $40 million range for 2023.

    向下移動損益表。我們預計毛利率與 2022 年相比有所改善,毛利率預計將處於 60% 的高位範圍內,調整後的 EBITDA 處於十幾歲百分比範圍內,全年運營費用約為 1.4 億美元。最後,我們還預計,隨著項目繼續推進,我們將在 3000 萬美元的建設成本中分擔建設成本,從而增加資本投資以建設我們新的最先進的細胞療法製造設施和公司總部。到 2023 年為 4000 萬美元。

  • In total, this guidance points to accelerating company revenue growth in 2023 and continued strong profitability for the full year. In addition, we would also anticipate further acceleration of our total company revenue growth in 2024 with a full year of NexoBrid in the market and the anticipated launch of arthroscopic MACI.

    總的來說,這一指引表明公司在 2023 年的收入將加速增長,全年將繼續保持強勁的盈利能力。此外,我們還預計,隨著 NexoBrid 全年上市以及關節鏡 MACI 的預期推出,我們公司的總收入增長將在 2024 年進一步加速。

  • This concludes our prepared remarks. We will now open the call to your questions.

    我們準備好的發言到此結束。我們現在將打開您的問題的電話。

  • Operator

    Operator

  • (Operator Instructions) Our first call comes from Ryan Zimmerman.

    (操作員說明)我們的第一個電話來自 Ryan Zimmerman。

  • Ryan Benjamin Zimmerman - MD & Medical Technology Analyst

    Ryan Benjamin Zimmerman - MD & Medical Technology Analyst

  • Congrats on the progress this year. I want to start with Epicel a little bit just because the guidance is a little lower than I think we were expecting, and I understand it's volatile. NexoBrid is going to help offset that. But when you think about that run rate, that $24 million run rate, do you feel like you've sufficiently set a floor here to account for the variability given how unpredictable it is? And just help us understand kind of how you came to that $4 million to $8 million on NexoBrid? Why is that right? Why is it not less? Why is it not more? Just would appreciate understanding your thought process and coming to that number.

    祝賀今年的進步。我想從 Epicel 開始一點點,因為指導比我認為我們預期的要低一點,而且我知道它是不穩定的。 NexoBrid 將幫助抵消這一點。但是當你想到那個運行率,那個 2400 萬美元的運行率時,你是否覺得你已經在這裡設置了一個底線來考慮可變性,因為它是多麼不可預測?並幫助我們了解您是如何在 NexoBrid 上獲得 400 萬至 800 萬美元的?為什麼是對的?為什麼不會少呢?為什麼不多了?只是希望了解您的思維過程並得出這個數字。

  • Joseph Anthony Mara - CFO & Treasurer

    Joseph Anthony Mara - CFO & Treasurer

  • Ryan, thanks for the question. This is Joe. I'll starting that one. So I think on Epicel, so first, it's important to realize with Epicel from a run rate perspective, to your question, we're very mindful of kind of where the business is. So the Q4 revenue was roughly $6 million. What we talked about in the prepared remarks as we move into Q1 is we would expect a similar revenue number, around $6 million. Although to your point, it's always difficult to predict exactly what that looks like based on the small patient numbers, et cetera. So it obviously could be a bit different quarter-to-quarter. But we do feel like that run rate, we saw that coming -- exiting last year. That's where we started this year.

    瑞安,謝謝你的提問。這是喬。我會開始那個。所以我認為在 Epicel 上,首先,重要的是從運行率的角度認識到 Epicel,對於你的問題,我們非常注意業務的位置。因此,第四季度的收入約為 600 萬美元。當我們進入第一季度時,我們在準備好的評論中談到的是,我們預計會有類似的收入數字,約為 600 萬美元。儘管就您的觀點而言,總是很難根據少量患者等準確預測結果。因此,顯然每個季度可能會有所不同。但我們確實覺得這種運行率,我們看到了它的到來 - 去年退出。這就是我們今年的起點。

  • As we think about the framework for guidance, maybe turning to that for a moment, so the way we're thinking about it is that $24 million is really appropriate starting point for Epicel. So basically, that $6 million run rate per quarter. And certainly, we will look to grow from there. Yes, If you look in prior years kind of pre-2021, we had more significant growth. You typically saw growth in kind of mid-single digit or low double-digit range. So if you do the math there, you could get up to, call it, $25 million, $26 million, perhaps a bit more. Again, right now, to your question, we're on that $24 million run rate.

    當我們考慮指導框架時,可能會考慮一下,所以我們的想法是,2400 萬美元是 Epicel 真正合適的起點。所以基本上,每季度 600 萬美元的運行率。當然,我們將尋求從那裡發展。是的,如果你看一下 2021 年之前的前幾年,我們有更顯著的增長。您通常會看到中個位數或低兩位數範圍內的增長。因此,如果您在那裡進行數學計算,您可能會達到 2500 萬美元、2600 萬美元,甚至更多。同樣,現在,對於你的問題,我們的運行率是 2400 萬美元。

  • So as we then think about the total guidance, that's where NexoBrid is important as well. So we feel like the combination of the two products can get us into that $28 million to $32 million range for the full year. And again, we want to be mindful of kind of where Epicel trends are right now as part of that.

    因此,當我們考慮總體指導時,這也是 NexoBrid 的重要之處。因此,我們覺得這兩種產品的結合可以使我們全年進入 2800 萬至 3200 萬美元的範圍。再一次,我們想要注意 Epicel 趨勢現在作為其中的一部分。

  • What that points to your NexoBrid question is, as we talked about in the prepared remarks, we've certainly seen some strong indicators so far. We still expect commercial availability in the second quarter. And again, from a cadence perspective, there'll be no revenue in the first quarter, some modest stocking in the second quarter and then really increase as we get into Q3, Q4. So if you kind of think about the guidance framework, and again, we're not giving specific numbers by product, which is why we're talking about the franchise, but that does put you in kind of that mid-single-digit range, which based on kind of what we've seen to date, I think kind of makes sense for NexoBrid.

    正如我們在準備好的評論中談到的那樣,指向你的 NexoBrid 問題的是,到目前為止,我們當然已經看到了一些強有力的指標。我們仍然預計第二季度的商業可用性。再一次,從節奏的角度來看,第一季度不會有收入,第二季度會有一些適度的庫存,然後隨著我們進入第三季度、第四季度而真正增加。因此,如果您考慮一下指導框架,我們不會按產品給出具體數字,這就是我們談論特許經營權的原因,但這確實讓您處於中個位數範圍內,根據我們迄今為止所看到的情況,我認為這對 NexoBrid 來說有點意義。

  • And again, we think we take a pretty meaningful share over the long term. So again, we're thinking about it from a franchise perspective. But when we think about where Epicel is and potential of NexoBrid, I think it's the appropriate range for this year.

    再一次,我們認為從長遠來看,我們佔據了相當有意義的份額。因此,我們再次從特許經營的角度考慮它。但當我們考慮 Epicel 的位置和 NexoBrid 的潛力時,我認為這是今年的合適範圍。

  • Ryan Benjamin Zimmerman - MD & Medical Technology Analyst

    Ryan Benjamin Zimmerman - MD & Medical Technology Analyst

  • Okay. Let me turn to MACI for a moment, and just one housekeeping question. Joe, did you say 20% growth off of first quarter '21? I thought I heard you say that, not first quarter 2022? Or was that just a mistake?

    好的。讓我暫時轉向 MACI,還有一個內務管理問題。喬,你是說 21 年第一季度增長 20% 嗎?我想我聽到你這麼說了,不是 2022 年第一季度?或者那隻是一個錯誤?

  • Joseph Anthony Mara - CFO & Treasurer

    Joseph Anthony Mara - CFO & Treasurer

  • Yes, sorry, first quarter of 2022 20% year-over-year growth in Q1.

    是的,抱歉,2022 年第一季度第一季度同比增長 20%。

  • Ryan Benjamin Zimmerman - MD & Medical Technology Analyst

    Ryan Benjamin Zimmerman - MD & Medical Technology Analyst

  • Okay. All right. Okay. I just wanted to check. And then so as I think about the MACI business, I think your guidance is very clear about what's included in that business, what that -- what could be upside. Do you -- and your comments around productivity are also helpful, Nick. But when you think about the arthroscopic delivery addition, do you feel like you need to upsize the sales force to capture that opportunity? Or is the sales force appropriately sized? I think it was 76 last we checked. And just given a broader customer base, why not upsize it if productivity is going to keep growing implied by kind of your comments?

    好的。好的。好的。我只是想檢查一下。然後,當我考慮 MACI 業務時,我認為你的指導非常清楚該業務中包含的內容,以及可能有什麼好處。尼克,您對生產力的評論也很有幫助。但是,當您考慮增加關節鏡交付時,您是否覺得需要擴大銷售隊伍才能抓住這個機會?或者銷售隊伍的規模是否合適?我想我們上次檢查是 76。鑑於更廣泛的客戶群,如果您的評論暗示生產力將繼續增長,為什麼不擴大規模呢?

  • Dominick C. Colangelo - CEO, President & Director

    Dominick C. Colangelo - CEO, President & Director

  • Yes, Ryan, this is Nick. So number one, you're right. We did increase our sales force from by about 50% from 49 to 76 territories back in 2020. And at that point, leading into that, our rep productivity was -- had gotten up to a couple million dollars a year. As you remember, it kind of grew even as we were expanding from sales force size in the 20s, up through 50, and we're kind of now back at that range given the current MACI guidance.

    是的,瑞安,這是尼克。所以第一,你是對的。早在 2020 年,我們確實將銷售人員從 49 個地區增加到 76 個地區,增加了約 50%。那時,我們的銷售代表生產力已經達到每年幾百萬美元。正如你記得的那樣,即使我們從 20 年代的銷售人員規模擴大到 50 人,它也在增長,而且根據當前的 MACI 指導,我們現在有點回到那個範圍。

  • I think what we'll end up doing, as we've mentioned before, around arthroscopic MACI, is going back and refreshing sort of the targeting work that we did back in 2019, the Health Advances project. As we talked about at that time, we know there's a meaningful segment of those 10,000-plus surgeons that we had both arthroscopic and open procedure data on that, either exclusively or predominantly do arthroscopic procedure.

    我認為,正如我們之前提到的,圍繞關節鏡 MACI,我們最終要做的是回顧並更新我們在 2019 年所做的目標工作,即 Health Advances 項目。正如我們當時談到的那樣,我們知道在這 10,000 多名外科醫生中有一個有意義的部分,我們有關節鏡和開放手術數據,專門或主要進行關節鏡手術。

  • So that may mean we add some number of new surgeons. And if that's large enough that it would justify increasing the sales force, that's certainly something we think about. So we'll be doing that work during this year ahead of the potential launch next year.

    所以這可能意味著我們要增加一些新的外科醫生。如果這足以證明增加銷售隊伍是合理的,那肯定是我們考慮的事情。因此,在明年可能推出之前,我們將在今年完成這項工作。

  • Operator

    Operator

  • (Operator Instructions) Our next call comes from Sam Brodovsky of Truist Securities.

    (操作員說明)我們的下一個電話來自 Truist Securities 的 Sam Brodovsky。

  • Samuel E. Brodovsky - Associate

    Samuel E. Brodovsky - Associate

  • Congrats on a good quarter. I'll just start with one on MACI in terms of -- and I appreciate you providing the components of the guidance. But in terms of things looking better to start the year, what would you need to see to start to incorporate either increasing conversion rates or an improving sort of patient census into the MACI guide?

    祝賀一個好的季度。我只是從關於 MACI 的內容開始——感謝您提供指南的組成部分。但就今年開始看起來更好的事情而言,您需要看到什麼才能開始將提高的轉化率或改進的患者普查納入 MACI 指南?

  • Joseph Anthony Mara - CFO & Treasurer

    Joseph Anthony Mara - CFO & Treasurer

  • Yes, this is Joe. I'll take that one to start. So I think -- from a MACI perspective, again, just to clarify Ryan's earlier comment, what we talked about was we've had a strong couple of quarters to close out last year, kind of both above 20%, which certainly is a good sign. And I think as we look into the first quarter, I think what we've really seen is strength in both biopsies, which really started in Q4 and then continued into Q1 as well as implants. So that's certainly an encouraging sign. And so our expectation in the first quarter is to be approximately 20%. I think it gets around $31 million for the quarter.

    是的,這是喬。我會從那個開始。所以我認為——再次從 MACI 的角度來看,只是為了澄清 Ryan 之前的評論,我們談到的是去年我們有幾個強勁的季度結束,都超過 20%,這當然是好兆頭。而且我認為,當我們研究第一季度時,我認為我們真正看到的是兩次活檢的實力,它真正從第四季度開始,然後一直持續到第一季度以及植入物。所以這當然是一個令人鼓舞的跡象。因此,我們對第一季度的預期約為 20%。我認為本季度收入約為 3100 萬美元。

  • As we think about the full year, a couple of things to keep in mind there. We do think about kind of that seasonality and mix by quarter. So that kind of number in Q1 actually lines up again to roughly 20% of our full year. If you look at the midpoint, for example, it's basically 20% of that full year number. So that's certainly something we're mindful of.

    當我們考慮全年時,有幾件事要記住。我們確實考慮了那種季節性,並按季度進行組合。因此,第一季度的這種數字實際上再次排成我們全年的大約 20%。例如,如果您查看中點,它基本上是全年數字的 20%。所以這當然是我們要注意的事情。

  • I'd also say we've probably seen some early signals that perhaps conversion rate is ticking up, but we generally measure that over a longer period of time. And I think what I would say is from our perspective, we want to see that over a longer period of time. We think the foundation is there, and the operating environment is improving. But we want to see some of those additional growth drivers, which we think can still be growth drivers for the brand. But in terms of 2023, we want to see it over a longer period of time before we know whether that's the case for multiple quarters.

    我還要說,我們可能已經看到一些早期信號,表明轉化率可能正在上升,但我們通常會在更長的時間內進行衡量。我想我要說的是從我們的角度來看,我們希望在更長的時間內看到這一點。我們認為基礎在那裡,經營環境正在改善。但我們希望看到一些額外的增長動力,我們認為它們仍然可以成為該品牌的增長動力。但就 2023 年而言,我們希望在更長的一段時間內看到它,然後才能知道多個季度的情況是否如此。

  • Samuel E. Brodovsky - Associate

    Samuel E. Brodovsky - Associate

  • That's helpful. And then just a quick one on NexoBrid for -- and thanks for providing the guide points there. Does guidance for this year contemplate any account outside of the existing Epicel base? Or does it just assume revenue coming from those accounts?

    這很有幫助。然後在 NexoBrid 上快速瀏覽一下——感謝您在那裡提供指導點。今年的指南是否考慮了現有 Epicel 基地之外的任何賬戶?或者它只是假設收入來自這些賬戶?

  • Dominick C. Colangelo - CEO, President & Director

    Dominick C. Colangelo - CEO, President & Director

  • Yes. Sam, this is Nick. No, we obviously have tiered need targets, and the sales force is focused on, as we talked about, the first thing you do aside from sort of surgeon training and hiring the sales force, training and deploying them. Really, it's about the P&T committee approval process. And so that is well underway, and that includes accounts that are Epicel users. But also if you'll recall, obviously, there was the Detect pivotal study at sites here in the U.S., the pediatric study, the ongoing NexoBrid or the next expanded access protocol. So three different clinical studies, where sites may have experience with NexoBrid. Often, those are also Epicel centers, but sometimes they're not. So I would just say that all 140 target burn centers are in play for the year, and we would expect utilization to come from both current Epicel burn centers, but then NexoBrid burn centers as well.

    是的。山姆,這是尼克。不,我們顯然有分層的需求目標,正如我們所說,銷售人員專注於你做的第一件事,除了外科醫生培訓和僱用銷售人員,培訓和部署他們。實際上,這是關於 P&T 委員會的審批流程。所以這一切都在順利進行,其中包括 Epicel 用戶的帳戶。但如果你還記得的話,很明顯,在美國這裡的站點進行了檢測關鍵研究、兒科研究、正在進行的 NexoBrid 或下一個擴展訪問協議。所以三個不同的臨床研究,其中網站可能有 NexoBrid 的經驗。通常,這些也是 Epicel 中心,但有時它們不是。所以我只想說今年所有 140 個目標燃燒中心都在發揮作用,我們預計利用率將來自當前的 Epicel 燃燒中心,但 NexoBrid 燃燒中心也是如此。

  • Operator

    Operator

  • (Operator Instructions) Our next call comes from Jeffrey Cohen of Landenburg.

    (操作員說明)我們的下一個電話來自 Landenburg 的 Jeffrey Cohen。

  • Jeffrey Scott Cohen - MD of Equity Research

    Jeffrey Scott Cohen - MD of Equity Research

  • Just a couple of questions from me, and if you could talk a little more about some of the human factors work you're doing in the arthroscopic setting as far as the device and its design. Is it locked down at this point?

    我只是幾個問題,如果你能多談談你在關節鏡環境中所做的一些人為因素的工作,就設備及其設計而言。這個時候是不是被封了?

  • Dominick C. Colangelo - CEO, President & Director

    Dominick C. Colangelo - CEO, President & Director

  • Yes, Jeff, I think -- and one thing you can do is go to our website, where we have a video of the MACI arthroscopic procedure, which I really think helps give people an understanding of exactly what the instrument set looks like and how MACI will be administered arthroscopically. And the context for the human factor study is that when we met with the FDA in December, we proposed that because we were not changing either the drug substance or the drug product just the way it was administered and because there's a fair amount of published data about the outcomes, good outcomes when MACI has delivered arthroscopically principally outside the U.S., when the product was available outside the U.S.

    是的,Jeff,我想——你可以做的一件事就是訪問我們的網站,我們有一個 MACI 關節鏡手術的視頻,我認為這有助於人們準確了解器械組的外觀和方式MACI 將通過關節鏡進行。人為因素研究的背景是,當我們在 12 月與 FDA 會面時,我們提出,因為我們沒有改變原料藥或藥物產品的給藥方式,而且因為有相當數量的公開數據關於結果,當 MACI 主要在美國境外提供關節鏡時,當產品在美國境外可用時,良好的結果

  • The FDA agreed that a human factor study would be an appropriate path going forward. So really, that means you bring in a number of orthopedic surgeons. You give them instructions on how to administer the product arthroscopically. They do it in a cadaver lab just to make sure that the interface -- the surgeon interface faced with the instruments is appropriate, and there's no issues there.

    FDA 同意人為因素研究將是前進的適當途徑。所以說真的,這意味著你要請來一些整形外科醫生。您向他們提供有關如何通過關節鏡使用該產品的說明。他們在屍體實驗室裡做這件事只是為了確保界面——外科醫生面對儀器的界面是合適的,而且那裡沒有問題。

  • And so it's a pretty streamlined path for us comparing and obviously, an accelerated regulatory pathway versus having had to do an actual clinical study. So that study is planned for this year, and we would plan to submit the label expansion to the FDA by the end of the year and would allow us to launch in 2024.

    因此,對於我們來說,這是一條非常簡化的路徑,顯然,加速監管路徑與必須進行實際臨床研究相比。所以這項研究計劃在今年進行,我們計劃在年底前向 FDA 提交標籤擴展,並允許我們在 2024 年推出。

  • Jeffrey Scott Cohen - MD of Equity Research

    Jeffrey Scott Cohen - MD of Equity Research

  • Okay. That's helpful. And then, Nick, could you talk about the consumable or reposable instrument kit and what portions may or may not be and how that might look from the payer standpoint as far as the actual procedures being done arthroscopically and the money flow there?

    好的。這很有幫助。然後,尼克,你能談談消耗品或可重複使用的儀器套件嗎?哪些部分可能是或可能不是?從付款人的角度來看,就關節鏡下進行的實際手術和那裡的資金流向而言,這看起來如何?

  • Dominick C. Colangelo - CEO, President & Director

    Dominick C. Colangelo - CEO, President & Director

  • Yes. So as you'll recall, for MACI, it's typically reimbursed under a J code. So it's a separate code that the payers -- under which the payers reimburse the product. There's obviously a procedure code, a CPT code in terms of how the surgeons get paid and then a facility fee. So that's kind of the current economics.

    是的。所以你會記得,對於 MACI,它通常根據 J 代碼報銷。所以這是一個單獨的代碼,付款人 - 付款人根據該代碼償還產品。顯然有一個程序代碼,一個關於外科醫生如何獲得報酬的 CPT 代碼,然後是設施費。這就是當前的經濟學。

  • These are -- the kit you can see in the video is basically a set of disposable instruments, different sized cutters, curets, things like that. And so exactly how we'll price those is to be determined, but it won't impact sort of the current reimbursement for the MACI product itself.

    這些是——您在視頻中看到的套件基本上是一套一次性器械、不同尺寸的刀具、刮匙等類似的東西。因此,我們將如何為這些產品定價還有待確定,但這不會影響當前對 MACI 產品本身的報銷。

  • Operator

    Operator

  • (Operator Instructions) Next question comes from Sean Lee of H.C. Wainwright.

    (操作員說明)下一個問題來自 H.C. 的 Sean Lee。溫賴特。

  • Sean Lee - Equity Research Associate

    Sean Lee - Equity Research Associate

  • Congratulations on finishing a great year. I just have two quick questions. One for NexoBrid. Can we expect any more orders from BARDA this year?

    祝賀你度過了美好的一年。我只有兩個簡單的問題。一個用於 NexoBrid。我們可以期待今年 BARDA 的更多訂單嗎?

  • Joseph Anthony Mara - CFO & Treasurer

    Joseph Anthony Mara - CFO & Treasurer

  • Yes. No. So that's -- we're -- no orders from BARDA this year, just commercial.

    是的。不,所以那是——我們——今年沒有來自 BARDA 的訂單,只是商業訂單。

  • Sean Lee - Equity Research Associate

    Sean Lee - Equity Research Associate

  • Okay. Great. And in terms of the launch strategy for NexoBrid, would you be targeting all the burn centers at the same time, similar to what Epicel is doing? Or would you -- starting in certain geographies as far as before rolling out nationwide?

    好的。偉大的。就 NexoBrid 的啟動策略而言,您是否會同時瞄準所有燒傷中心,類似於 Epicel 正在做的事情?或者你會 - 從某些地區開始,直到在全國范圍內推廣?

  • Dominick C. Colangelo - CEO, President & Director

    Dominick C. Colangelo - CEO, President & Director

  • Well, as we've talked about previously, of the 140 accredited burn centers in the U.S. each year, Epicel is typically used in probably half of them. So obviously, we have relationships in those accounts. We are adding sales reps that will focus on the other accounts with NexoBrid only to start. And so we've tiered them out by patient volumes, claims data, et cetera. And obviously, you focus on high-volume centers first. So it will be, as I mentioned earlier on the call or in the Q&A session, that we'll be targeting both current Epicel using centers as well as high-volume centers that have been involved in the various studies for NexoBrid here in the U.S.

    好吧,正如我們之前談到的那樣,在美國每年 140 個經過認證的燒傷中心中,大約有一半通常使用 Epicel。很明顯,我們在這些賬戶中有關係。我們正在增加銷售代表,他們將專注於 NexoBrid 的其他客戶,只是為了開始。因此,我們根據患者數量、索賠數據等對它們進行了分層。顯然,您首先關注高容量中心。因此,正如我之前在電話會議或問答環節中提到的那樣,我們將同時針對當前的 Epicel 使用中心以及參與美國 NexoBrid 各種研究的高容量中心。

  • Sean Lee - Equity Research Associate

    Sean Lee - Equity Research Associate

  • I see. That's helpful. And my final question is just on the new manufacturing futility. Is everything still on track there, still ready to be still expected to be completed in 2024?

    我懂了。這很有幫助。我的最後一個問題是關於新製造的無用性。那裡的一切是否仍在軌道上,是否仍準備好預計在 2024 年完成?

  • Dominick C. Colangelo - CEO, President & Director

    Dominick C. Colangelo - CEO, President & Director

  • Yes. So everything remains on track. The tenant improvement part of the project is scheduled to be completed by the end of 2024. Of course, we mentioned that we would expect commercial production in early 2026. So really, that 2025 time period is FDA inspection and validation of the new facility.

    是的。所以一切都在軌道上。該項目的租戶改善部分計劃於 2024 年底完成。當然,我們提到我們預計在 2026 年初進行商業生產。所以實際上,2025 年是 FDA 對新設施的檢查和驗證。

  • Operator

    Operator

  • Thank you very much. I would now like to turn the call back to Nick Colangelo for closing remarks.

    非常感謝。我現在想把電話轉回給 Nick Colangelo,請其作結束語。

  • Dominick C. Colangelo - CEO, President & Director

    Dominick C. Colangelo - CEO, President & Director

  • Okay. Well, thank you very much, and thanks to everyone for your questions and your continued interest in the company. Overall, we delivered strong financial and business results to close the year in 2022, and we expect another year of significant top line revenue growth and strong profitability and operating cash flow driven by both our commercial franchises in 2023. Given our significant market opportunities for the products and our strong financial profile, we really believe that the company is well-positioned for sustained long-term growth in the years ahead. So thanks again, and have a great day.

    好的。嗯,非常感謝,也感謝大家提出的問題和對公司的持續關注。總體而言,我們在 2022 年結束了這一年,取得了強勁的財務和業務業績,我們預計 2023 年我們的兩個商業特許經營將推動又一年收入顯著增長以及強勁的盈利能力和運營現金流。鑑於我們的重要市場機會產品和我們強大的財務狀況,我們真的相信公司在未來幾年的持續長期增長中處於有利地位。再次感謝,祝你有美好的一天。

  • Operator

    Operator

  • Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.

    感謝您參加今天的會議。這確實結束了程序。您現在可以斷開連接。