Vericel Corp (VCEL) 2023 Q4 法說會逐字稿

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  • Operator

    Operator

  • Ladies and gentlemen, thank you for standing by, and welcome to Vericel's Fourth Quarter 2023 conference call. At this time, all participants are in a listen only mode. I would also like to remind you that this call is being recorded for replay. I will now turn the conference call over to Julie Downs, Vericel's Head of Corporate Communications.

    女士們、先生們,感謝你們的支持,並歡迎參加 Vericel 的 2023 年第四季電話會議。此時,所有參與者都處於只聽模式。我還想提醒您,本次通話正在錄音以供重播。我現在將電話會議轉交給 Vericel 企業傳播主管 Julie Downs。

  • Julie Downs - Head of Corporate Communications

    Julie Downs - Head of Corporate Communications

  • Thank you operator, and good morning, everyone. Welcome to Vericel's Fourth Quarter 2023 conference call to discuss our financial results and business highlights. Before we begin, let me remind you that 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 our 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. Please note that a copy of our fourth quarter financial results press release is available in the Investor Relations section of our website.

    謝謝接線員,大家早安。歡迎參加 Vericel 的 2023 年第四季電話會議,討論我們的財務表現和業務亮點。在開始之前,請允許我提醒您,在今天的電話會議上,我們將根據 1995 年《私人證券訴訟改革法案》做出前瞻性聲明。這些陳述可能涉及風險和不確定性,可能導致實際結果與我們的預期產生重大差異,並且在我們向 SEC 提交的文件中進行了更全面的描述,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今天的觀點,不應被視為代表我們在任何後續日期的觀點。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。

  • We also have a short presentation with highlights from today's call that can be viewed directly on the webcast. Our access on our website I am joined on the call by their results, President and Chief Executive Officer, Nick Colangelo, and our Chief Financial Officer, Joe Lara. I will now turn the call over to Nick.

    我們還有一個簡短的演示,其中包含今天電話會議的要點,可以直接在網路廣播上觀看。我們在網站上的訪問 我與他們的結果、總裁兼首席執行官 Nick Colangelo 和我們的首席財務官 Joe Lara 一起參加了電話會議。我現在將把電話轉給尼克。

  • Nick Colangelo - CEO, President & Director

    Nick Colangelo - CEO, President & Director

  • Thank you, Julie, and good morning, everyone. I'll begin today's call by discussing financial and business highlights for the fourth quarter and full year as well as our expectations for 2020 for Joe will then provide a more detailed update on our 2023 financial results and the financial guidance for this year.

    謝謝朱莉,大家早安。我將在今天的電話會議開始時討論第四季度和全年的財務和業務亮點以及我們對 2020 年的預期,然後喬將提供有關我們 2023 年財務業績和今年財務指導的更詳細的更新。

  • Before opening the call to Q&A, the company executed exceptionally well in 2023 and delivered outstanding financial and business results in the fourth quarter, generating top-tier revenue growth and even higher profitability growth. Total revenue for the full year increased 20% to over $197 million, which was at the top end of our guidance range, with MACI revenue growing 25% to nearly $165 million in burn care revenue of nearly $33 million. The company also reached an inflection point with respect to our profitability profile with bottom line profitability growing at twice the rate of our top-line revenue growth as adjusted EBITDA increased 40% to $34 million, and we generated over $35 million of operating cash flow, ending the year with approximately $153 million in cash and investments and no debt.

    在開始問答之前,該公司在 2023 年表現出色,在第四季度實現了出色的財務和業務業績,實現了頂級的收入增長,甚至更高的盈利增長。全年總收入成長 20%,超過 1.97 億美元,處於我們指引範圍的上限,其中 MACI 收入成長 25%,達到近 1.65 億美元,燒傷護理收入近 3,300 萬美元。該公司的獲利狀況也達到了轉折點,底線獲利能力的成長速度是頂線收入成長速度的兩倍,調整後的EBITDA 成長了40%,達到3,400 萬美元,我們產生了超過3,500 萬美元的營運現金流。截至年底,公司擁有約 1.53 億美元的現金和投資,無債務。

  • The company also had a very strong close to the year as we generated record total revenue of $65 million in the fourth quarter, an increase of 23% over the prior year. Our strong fourth quarter performance was driven by record quarterly, may see revenue of nearly $57 million, which was above the high end of our guidance range and representing more than 50% sequential growth over the third quarter and 22% growth over the fourth quarter of 2022 marking the sixth straight quarter of 20 plus percent growth for MEC.

    該公司在年底也取得了非常強勁的業績,第四季總收入達到創紀錄的 6,500 萬美元,比上年增長 23%。我們強勁的第四季度業績是由創紀錄的季度業績推動的,收入可能接近 5700 萬美元,高於我們指導範圍的上限,比第三季度環比增長 50% 以上,比第四季度增長 22%。 2022 年,MEC 將連續第六個季度實現20% 以上的成長。

  • This outstanding IBC revenue performance was driven by strong underlying business fundamentals as we had the highest number of MEC implants, implanting surgeons, surgeons taking biopsies and biopsies in any quarter since launch. We also generated very strong growth in the burn care franchise as fourth quarter revenue grew 31% over the prior year. Our top line revenue performance drove significant margin expansion and profit growth in the fourth quarter as we generated gross margin of 75% and adjusted EBITDA margin of 34%, with adjusted EBITDA growing 50% to over $22 million and net income for the quarter more than doubling to $13 million. As we look forward to 2024 and beyond, we expect that continued high revenue growth will drive further expansion of our margins and enhancement of our profitability metrics.

    IBC 出色的收入表現是由強勁的業務基本面推動的,因為自推出以來的任何一個季度,我們擁有最多數量的 MEC 植入物、植入外科醫生、進行活檢和活檢的外科醫生。我們的燒傷護理特許經營業務也實現了非常強勁的成長,第四季營收比上一年增長了 31%。我們的營收表現推動了第四季利潤率的顯著擴張和利潤成長,毛利率為75%,調整後EBITDA 利潤率為34%,調整後EBITDA 成長50%,超過2,200 萬美元,本季淨利潤超過翻倍達到 1300 萬美元。展望 2024 年及以後,我們預期營收的持續高成長將推動我們的利潤率進一步擴大並提高我們的獲利指標。

  • From a commercial perspective, MACI's sustained growth has been driven by continued expansion of our surgeon customer base as we had another year of double digit growth in surgeons taking biopsies in 2023, we're now approaching 50% penetration of our current 5,000 target surgeons, the expansion of our surgeon base and the corresponding growth in biopsies has fueled MACI's success and helped drive sales rep productivity to its highest level ever at $2.2 million per rep in 2023. Our commercial team continues to execute high-quality peer-to-peer programs to help drive surgeon uptake that we had our highest number of programs to date in the fourth quarter, demonstrating that interest in may see continues to grow in addition, Mesa's positive long-term clinical outcomes were highlighted in a prospective study published in the American Journal of Sports Medicine last week. The study showed improved clinical scores, high levels of patient satisfaction and clinical and MRI based outcomes that were maintained out to 10 years for patients treated with MACI. The study also showed excellent long-term outcomes for MACI patients treated for both patella femoral and femoral ConBio defects, which is the focus of our MACIR. two approach based on the strength of MACI's clinical outcomes, top line revenue performance and its underlying growth drivers. Our core MACI business remains very well positioned for continued strong growth in 2024 in the years ahead.

    從商業角度來看,MACI 的持續成長是由我們的外科醫生客戶群的持續擴張所推動的,因為我們在2023 年進行活檢的外科醫生數量又實現了兩位數增長,我們目前的5,000 名目標外科醫生的滲透率已接近50%,我們外科醫生基礎的擴大以及活檢的相應增長推動了MACI 的成功,並幫助將銷售代表的生產力推至歷史最高水平,到2023 年每位銷售代表將達到220 萬美元。我們的商業團隊繼續執行高品質的點對點計劃,以幫助推動外科醫生的採用,我們在第四季度擁有迄今為止數量最多的計劃,這表明人們對可能看到的興趣繼續增長,此外,梅薩的積極長期上週《美國運動醫學雜誌》發表的一項前瞻性研究強調了長期臨床結果。該研究表明,接受 MACI 治療的患者臨床評分有所改善,患者滿意度較高,且基於臨床和 MRI 的結果可維持長達 10 年。研究也顯示,接受髕骨股骨和股骨 ConBio 缺陷治療的 MACI 患者俱有良好的長期結果,這也是我們 MACIR 的重點。兩種方法是基於 MACI 的臨床結果、頂線收入表現及其潛在成長動力的實力。我們的核心 MACI 業務仍處於有利地位,將在未來幾年的 2024 年持續強勁成長。

  • Looking beyond this core base of growth to our lifecycle management and indication expansion initiatives. We announced last month that our may see arthroscopic delivery submission was accepted for review by the FDA and that we expect to launch may CR through in the third quarter of this year. As we previously discussed, the MACI ArthroCare Target's two to four square centimeter femoral ConBio defect, which comprise the largest segment of our addressable market, representing approximately 20,000 patients per year or roughly third of the $3 billion addressable market for MEC. In January, the US PTO issued a patent covering the complete set of MACI Arthur instruments into 2043, underscoring our market research indicating that orthopedic surgeons view may CR through a meaningful innovation in the cartilage repair market and that regardless of their current may see usage.

    超越這個核心成長基礎,專注於我們的生命週期管理和適應症擴展計畫。我們上個月宣布,我們的 May See 關節鏡遞送提交資料已被 FDA 接受審查,我們預計將在今年第三季推出 May CR。正如我們之前所討論的,MACI ArthroCare Target 的 2 至 4 平方公分股骨 ConBio 缺損構成了我們潛在市場的最大部分,代表每年約 20,000 名患者,約佔 MEC 30 億美元潛在市場的三分之一。今年1 月,美國專利商標局(PTO) 頒發了一項專利,涵蓋到2043 年的全套MACI Arthur 器械,這強調了我們的市場研究表明,骨科醫生認為可以通過軟骨修復市場中的有意義的創新來實現CR,並且無論其當前如何,都可能會看到使用。

  • Certainly surgeons expect to shift a meaningful share of their procedures to the MACIR. through a procedure. Our prelaunch commercial activities are well underway in. And in addition, in connection with the May CR3 launch, we'll be expanding our surgeon target base from 5,000 to approximately 7,000 surgeons to include surgeons that perform high volumes of cartilage repair, predominantly through arthroscopic procedures. Based on our experience to date, we'd expect to achieve more than 50% penetration of this larger target surgeon base over time, meaning that surgeon adoption and biopsy growth will continue to be important growth drivers for me, see in the years ahead. We're very excited about the anticipated launch of new ZR for later this year as we believe it represents another significant growth opportunity for MACI and a key value driver for our business moving forward.

    當然,外科醫生希望將他們的手術中有意義的部分轉移到 MACIR。透過一個程序。我們的預發布商業活動正在順利進行中。此外,隨著 5 月 CR3 的推出,我們將把我們的外科醫生目標基礎從 5,000 名外科醫生擴大到大約 7,000 名外科醫生,其中包括主要透過關節鏡手術進行大量軟骨修復的外科醫生。根據我們迄今為止的經驗,我們預計隨著時間的推移,這個更大的目標外科醫生群體的滲透率將達到50% 以上,這意味著外科醫生的採用和活檢的增長將繼續成為我的重要增長動力,看到未來幾年。我們對今年稍後預計推出的新 ZR 感到非常興奮,因為我們相信它代表 MACI 的另一個重大成長機會,也是我們業務向前發展的關鍵價值驅動力。

  • We're also advancing our MACI development program for the treatment of cartilage injuries in the ankle and expect to initiate the MACI ankle clinical study in 2025. Cartilage defects in the ankle represent the second largest market opportunity for MACI. And we believe that a potential anchor indication with an estimated $1 billion addressable market could be another significant growth driver for may see in the next decade and beyond.

    我們也正在推進用於治療腳踝軟骨損傷的 MACI 開發計劃,並預計於 2025 年啟動 MACI 腳踝臨床研究。腳踝軟骨缺損是 MACI 的第二大市場機會。我們相信,一個估計價值 10 億美元的潛在市場的潛在錨定跡象可能會成為未來十年及更長時間內的另一個重要成長動力。

  • Turning to our burn care franchise. We also saw strength in the underlying business fundamentals for Epicel in the fourth quarter as we had the highest number of Epicel biopsies in the quarter. Since 2021, and that momentum is carried into 2024. With a strong start to the year, we continued to see positive pull through for episode from our expanded burn care sales team, which further supports our belief that Epicel will benefit from a larger commercial footprint and higher share of voice in the burn care market.

    轉向我們的燒傷護理專營權。我們還看到第四季度 Epicel 的基本業務基本面強勁,因為我們在該季度進行了最高數量的 Epicel 活檢。自 2021 年以來,這一勢頭將延續到 2024 年。憑藉今年的強勁開局,我們繼續看到我們擴大的燒傷護理銷售團隊取得了積極的進展,這進一步支持了我們的信念,Epicel 將受益於燒傷護理市場更大的商業足跡和更高的話語權。

  • With respect to NexoBrid our burn care team is executing on the initial phases of our launch plan following commercial availability of the product in the US beginning in the fourth quarter of last year. Our commercial and medical teams remain focused on building a strong foundation for NexoBrid by supporting P&T committee approvals to enable burn care center, access to NexoBrid training, burn surgeons and their staffs and supporting initial cases of burn centers to ensure successful patient outcomes. We're pleased with the progress that we made in the fourth quarter.

    對於 NexoBrid,我們的燒傷護理團隊正在執行我們推出計劃的初始​​階段,該產品於去年第四季開始在美國上市。我們的商業和醫療團隊仍然專注於為NexoBrid 奠定堅實的基礎,支持P&T 委員會批准啟用燒傷護理中心、獲得NexoBrid 培訓、燒傷外科醫生及其員工以及支持燒傷中心的初始病例,以確保患者獲得成功的治療結果。我們對第四季的進展感到滿意。

  • In terms of the early launch fees, key performance indicators for onboarding burn centers. As of the end of 2023, more than 50 burn centers had submitted packages to their P&T committees. More than 25 centers had gained P and T committee approval and nearly 20 centers placed in initial product orders. While our performance on these metrics was strong.

    就早期啟動費用而言,入職燒錢中心的關鍵績效指標。截至 2023 年底,已有 50 多家燒傷中心向其 P&T 委員會提交了包裹。超過 25 個中心已獲得 P and T 委員會的批准,近 20 個中心已下達初始產品訂單。雖然我們在這些指標上的表現非常強勁。

  • As we mentioned on our last call, the manufacturing related delay in 2023 and the resulting uncertainty around the ultimate timing of product availability did cause a number of burn centers to defer delayed NexoBrid training and P and T can Mitie approval processes, which in addition to the typical administrative hurdles at hospitals impacts ordering patterns and the timing of use and uptake at many of these centers. Most importantly, however, the clinical outcomes for the initial patients treated with NexoBrid and the feedback from burn surgeons treating those patients has been very positive, which serves as a great signal for the long-term potential of NexoBrid as we look to change the standard of care for eschar removal for patients with severe burns.

    正如我們在上次電話會議中提到的,2023 年與製造相關的延遲以及由此產生的產品最終上市時間的不確定性確實導致許多燒傷中心推遲了NexoBrid 培訓和P and T can Mitie 批准流程,這除了醫院的典型行政障礙影響了許多此類中心的訂購模式以及使用和吸收的時間。然而,最重要的是,最初使用 NexoBrid 治療的患者的臨床結果以及治療這些患者的燒傷外科醫生的反饋非常積極,這對 NexoBrid 的長期潛力來說是一個很好的信號,因為我們希望改變標準嚴重燒傷患者去除焦痂的照護。

  • In addition to the progress with initial burn center onboarding, we also completed a number of initiatives designed to build a strong foundation for NexoBrid commercial success over time. In the fourth quarter, we submitted a supplemental BLA for a pediatric indication for NexoBrid that was accepted for review by the FDA. Currently commercial access, CMS granted NexoBrid a permanent J-code in transitional pass-through payment status, which became effective in January and provides a reimbursement pathway for the outpatient treatment of appropriate NexoBrid patients in our target burn centers as well as additional hospitals over time. So overall, we're very pleased with the strong surgeon interest in NexoBrid, our progress in market access activities and onboarding burn centers, the excellent clinical outcomes and positive feedback from surgeons treating patients and a clear impact that our broader burden care portfolio and expanded sales team is having an episode. We believe that all of these factors will enable the Company to build a strong foundation for NexoBrid in 2024, meaningfully contribute to our burn care franchise revenue this year enables the Company to have a second high-growth franchise in burn care moving forward.

    除了最初的燒傷中心入職取得進展外,我們還完成了許多旨在為 NexoBrid 隨著時間的推移取得商業成功奠定堅實基礎的舉措。在第四季度,我們提交了 NexoBrid 兒科適應症的補充 BLA,該 BLA 已被 FDA 接受審查。目前已獲得商業准入,CMS 授予 NexoBrid 過渡性直通支付狀態的永久 J 代碼,該代碼於 1 月生效,並為我們的目標燒傷中心以及其他醫院的適當 NexoBrid 患者的門診治療提供了報銷途徑。因此,總的來說,我們對外科醫生對NexoBrid 的強烈興趣、我們在市場准入活動和燒傷中心入職方面取得的進展、治療患者的外科醫生的出色臨床結果和積極反饋以及我們更廣泛的負擔護理產品組合和擴大的明顯影響感到非常高興銷售團隊有一個小插曲。我們相信,所有這些因素將使公司能夠在2024 年為NexoBrid 奠定堅實的基礎,為我們今年的燒傷護理特許經營收入做出有意義的貢獻,使公司能夠在燒傷護理領域擁有第二個高增長的特許經營權。

  • Finally, turning to guidance for 2024. We expect continued strong revenue growth of 20 plus percent with full year revenue of $237 million to $241 million, driven by the continued strength in our core portfolio, our first full year of NexoBrid revenue, which will contribute to growth this year and even more meaningfully so next year and the anticipated launch of DCR through in the third quarter, which is expected to generate some revenue towards the end of the year and support a sustained high level of growth for MACI and the company in 2025 and beyond. We also expect that our sustained high revenue growth will drive further expansion of our margins and growth in our profitability metrics. I'll now turn the call over to Joe

    最後,轉向 2024 年指引。我們預計,在我們核心產品組合持續強勁的推動下,營收將繼續強勁增長20% 以上,全年收入將達到2.37 億美元至2.41 億美元,這是我們NexoBrid 收入的第一個全年收入,這將有助於今年的成長,甚至更有意義因此,預計明年將推出DCR,預計將在第三季推出,預計將在年底前產生一些收入,並支持MACI 和公司在2025 年及以後的持續高水平增長。我們也預計,持續的高收入成長將推動我們的利潤率和獲利指標的進一步擴大。我現在將電話轉給喬

  • Joseph Mara - CFO & Treasurer

    Joseph Mara - CFO & Treasurer

  • Thanks, Nick, and good morning, everyone. Starting with our 2023 financial results. Total net revenue for the full year was $197.5 million, representing growth of 20%. Total net revenue in the fourth quarter was $65 million, with growth of 23%, driven by strong results from both of our franchises, MACI revenue of $164.8 million for the full year was above our guidance range from 25% versus the prior year. For Q4, MACI revenue was $56.7 million and grew 51% over the third quarter and 22% versus the prior year as we continued our momentum in the MACI business with our sixth consecutive quarter with growth over 20%. Total burn care revenue for the full year was $32.7 million, consisting of $31.6 million of Epicel revenue and $1.1 million of NexoBrid reps in the fourth quarter, our total burn care revenue increased by 31% with Epicel growth of 22% and the addition of NexoBrid revenue in the quarter, leading to a very strong fourth quarter for home care results.

    謝謝尼克,大家早安。從我們 2023 年的財務表現開始。全年總淨收入為 1.975 億美元,成長 20%。第四季總淨收入為6,500 萬美元,成長23%,得益於我們兩個特許經營業務的強勁業績,MACI 全年收入為1.648 億美元,高於我們的指導範圍(與上一年相比增長25%)。第四季度,MACI 營收為 5,670 萬美元,比第三季成長 51%,比上年增長 22%,我們繼續保持 MACI 業務的勢頭,連續第六個季度增長超過 20%。全年燒傷護理總收入為3,270 萬美元,其中包括第四季度3,160 萬美元的Epicel 收入和110 萬美元的NexoBrid 代表收入,隨著Epicel 增長22% 以及NexoBrid 的加入,我們的燒傷護理總收入增長了31%該季度的收入,導致第四季度家庭護理業績非常強勁。

  • Gross profit for the year was $135.6 million or 69% of net revenue, an increase of approximately 200 basis points compared to 2022. For the quarter, gross profit was $48.5 million or 75% of net revenue, which also increased by 200 basis points versus last year and represents the highest gross margin for the company in any quarter to date. In addition, our pull through of incremental revenue to gross profit has now returned to levels similar to 2019 with the pull through to gross margin of 83% for the fourth quarter and nearly 80% for the full year.

    全年毛利為 1.356 億美元,佔淨收入的 69%,較 2022 年成長約 200 個基點。該季度的毛利為 4,850 萬美元,佔淨收入的 75%,也比去年增加了 200 個基點,是該公司迄今為止任何季度的最高毛利率。此外,我們的增量收入對毛利的拉動現已恢復到與 2019 年類似的水平,第四季度的毛利率拉動為 83%,全年毛利率接近 80%。

  • Total operating expenses for the year were $142 million compared to $126.8 million in 2022. For the quarter, operating expenses were $35.8 million compared to $32.2 million for the same period in 2022. The increase in operating expenses in 2023 was primarily due to increased headcount and related employee expenses, lease expense associated with the company's new facility that is under construction, variable sales and marketing expenses as well as other external expense.

    今年的總營運支出為 1.42 億美元,而 2022 年為 1.268 億美元。本季營運費用為 3,580 萬美元,而 2022 年同期營運費用為 3,220 萬美元。2023 年營運費用的增加主要是由於員工人數和相關員工費用的增加、與公司在建新設施相關的租賃費用、可變銷售和行銷費用以及其他外部費用。

  • Net income for the fourth quarter more than doubled to $13 million or $0.26 per share compared to net income of $5.9 million or $0.12 per share for the fourth quarter of 2022. For the full year, our net loss was $3.2 million, or $0.07 per share compared to a loss of $16.7 million or $0.35 per share in 2022, representing an improvement of nearly $14 million on a year-over-year basis. Non-GAAP adjusted EBITDA for the year grew 40% to $33.9 million or 17% of net revenue compared to $24.2 million or 15% of net revenue in 2022.

    第四季的淨利潤成長了一倍多,達到 1,300 萬美元,即每股 0.26 美元,而 2022 年第四季的淨利潤為 590 萬美元,即每股 0.12 美元。全年淨虧損為 320 萬美元,即每股虧損 0.07 美元,而 2022 年虧損為 1,670 萬美元,即每股虧損 0.35 美元,年減近 1,400 萬美元。本年度非 GAAP 調整後 EBITDA 成長了 40%,達到 3,390 萬美元,佔淨收入的 17%,而 2022 年為 2,420 萬美元,佔淨收入的 15%。

  • For the quarter, adjusted EBITDA grew 50% to $22.3 million or 34% of net revenue, an increase of approximately 600 basis points versus 28% in the fourth quarter last year. Importantly, our adjusted EBITDA growth of 40% for the full year is double our top line revenue growth of 20%. And our adjusted EBITDA growth of 50% in the fourth quarter is more than double our revenue growth of 23% as our results continue to demonstrate very strong P&L leverage and a top-tier profitability profile.

    本季度,調整後 EBITDA 成長 50%,達到 2,230 萬美元,佔淨收入的 34%,比去年第四季的 28% 成長約 600 個基點。重要的是,我們全年調整後 EBITDA 成長 40%,是我們營收成長 20% 的兩倍。第四季調整後 EBITDA 成長 50%,是營收成長 23% 的兩倍多,因為我們的業績持續展現出非常強勁的損益槓桿和頂級的獲利能力。

  • In addition, the company has now consistently generated positive adjusted EBITDA each quarter for more than three years and continues to convert adjusted EBITDA into strong cash flow. We generated operating cash flow of $35.3 million in 2023. We ended the year with $152.6 million in cash, restricted cash and investments and no debt, up from approximately $140 million to start the year as our cash balance increased in 2023 despite CapEx investments for our new facility.

    此外,該公司目前在三年多的時間裡每季都持續產生正的調整後 EBITDA,並繼續將調整後 EBITDA 轉化為強勁的現金流。2023 年,我們的營運現金流為 3,530 萬美元。截至年底,我們的現金、限制性現金和投資為1.526 億美元,沒有債務,高於年初的約1.4 億美元,因為儘管我們對新設施進行了資本支出投資,但我們的現金餘額在2023 年有所增加。

  • Turning to our financial guidance for 2024 for using a similar guidance framework to start the year that we use in 2023 for both MACI and our burn care franchise. For the full year, we expect total company revenue of $237 million to $241 million, representing growth of approximately 20% to 22%, driven by continued strong growth in both of our franchise with may be on track for another strong year, Epicel benefiting from a high share, higher share of voice and NexoBrid early in its launch phase. We have multiple paths to our 20 plus percent total revenue guidance for the year. We expect another year another year of growth for MACI, another year of strong growth for MACI and as a starting point, we expect full year revenue growth in the high-teens percentage range with biopsy surgeon growth, biopsy growth and an increase in price continuing to serve as the key major growth drivers for the burn care franchise. We expect growth of over 30% for the full year based on significantly improved Epicel trends over the past several quarters, plus the initial revenue contribution.

    轉向我們 2024 年的財務指導,我們使用與 2023 年 MACI 和我們的燒傷護理特許經營權類似的指導框架來開始新的一年。我們預計全年公司總收入將達到2.37 億美元至2.41 億美元,成長約20% 至22%,這得益於我們兩個特許經營業務持續強勁增長的推動,可能會迎來又一個強勁的一年,Epicel 受益於高份額、更高的話語權份額以及 NexoBrid 在推出初期的階段。我們有多種途徑可以實現今年 20% 以上的總收入指引。我們預計 MACI 又一年將增長,MACI 將強勁增長,作為起點,我們預計全年收入將在高青少年百分比範圍內增長,活檢外科醫生的增長、活檢的增長和價格的持續上漲成為燒傷護理專營權的主要成長動力。基於過去幾季 Epicel 趨勢的顯著改善以及最初的營收貢獻,我們預計全年成長將超過 30%。

  • Next for the first quarter, we expect a strong start to the year with total company revenue of approximately $48 million to $50 million, representing approximately 20% revenue growth at the midpoint. We expect Q1 may see revenue of $38.5 million to $39.5 million. And for burn care, we expect total revenue in the first quarter to be $9.5 million to $10.5 million, with the vast majority of revenue coming from Epicel, which is trending above our recent run rates based on the strength of biopsies to close out 2023 and NexoBrid revenue to be in a similar range as Q4 moving down the P&L for the full year, we expect gross margin of approximately 70% of an adjusted EBITDA margin of approximately 20%, which would imply another year of very strong adjusted EBITDA growth of around 40%. We would expect similar quarterly trends in terms of seasonality and progression for both our gross margin and adjusted EBITDA margin percentages throughout the year. And we would expect operating expenses to be approximately $165 million for the full year. Finally, we anticipate an increase in capital investment for the build-out of our new manufacturing and headquarters facility with our share of construction costs expected to be in the $50 million range for 2024. In total, this guidance points to continued high revenue growth in 2024, with further enhancement of our top-tier profitability profile. In addition, we also anticipate continued strong revenue growth in 2025 with a full year of arthroscopic meeting and further acceleration of NexoBrid usage as well as continued expansion in our key profitability measures.

    接下來的第一季度,我們預計今年將有一個強勁的開局,公司總收入約為 4,800 萬美元至 5,000 萬美元,中間營收成長率約為 20%。我們預計第一季的營收可能為 3,850 萬美元至 3,950 萬美元。對於燒傷護理,我們預計第一季的總收入為 950 萬至 1050 萬美元,其中絕大多數收入來自 Epicel,根據截至 2023 年的活檢實力,該收入趨勢高於我們最近的運行率,並且NexoBrid 收入與第四季的營收處於類似範圍,全年損益表下降,我們預期毛利率約為70%,調整後EBITDA 利潤率約為20%,這意味著又一年調整後EBITDA 成長非常強勁40%。我們預計全年毛利率和調整後 EBITDA 利潤率在季節性和進展方面將出現類似的季度趨勢。我們預計全年營運費用約為 1.65 億美元。最後,我們預計將增加用於建設新製造和總部設施的資本投資,到 2024 年我們分擔的建設成本預計將在 5,000 萬美元左右。總的來說,指引指出 2024 年營收將持續高成長,我們的頂級獲利能力將進一步增強。此外,我們還預計,隨著全年的關節鏡會議、NexoBrid 使用的進一步加速以及我們關鍵盈利指標的持續擴展,2025 年收入將持續強勁增長。

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

    我們準備好的演講到此結束。我們將打開電話回答您的問題。

  • Operator

    Operator

  • Thank you. At this time, we will conduct a question-and-answer session. (Operator Instructions)

    謝謝。這時候,我們將進行問答環節。(操作員說明)

  • Ryan Zimmerman, BTIG.

    瑞安·齊默爾曼,BTIG。

  • Ryan Zimmerman - Analyst

    Ryan Zimmerman - Analyst

  • Good morning and congrats on a really strong 2023. I appreciate all the commentary on guidance this morning. Joe, wondering if you could talk a little bit about seasonality on a top line, though, have been it is kind of an abnormal year relative to years prior with the launch of NexoBrid, potentially some benefit late in the fourth in the third and fourth quarter for arthroscopic may see. I'm just curious if you could kind of expand a little bit on that in terms of how to think about maybe seasonality and pace this year given it is a little abnormal?

    早安,祝賀 2023 年非常強勁。我感謝今天早上所有關於指導的評論。喬,想知道您是否可以在最重要的方面談論季節性,不過,與前幾年相比,隨著NexoBrid 的推出,今年是一種不正常的一年,可能會在第四季度末在第三和第四季帶來一些好處四分之一進行關節鏡檢查可以看到。我只是好奇你是否可以在如何思考今年的季節性和節奏方面進行一些擴展,因為今年有點不正常?

  • Joseph Mara - CFO & Treasurer

    Joseph Mara - CFO & Treasurer

  • Yes. So thanks for the question, Ryan, and good morning. So I can hit on that. And maybe I'll just sort of start at a high level with guidance, just to make sure people understand on the framework, and then I can touch on the seasonality as part of that.

    是的。謝謝你的提問,瑞安,早安。所以我可以做到這一點。也許我會從高層次開始提供指導,只是為了確保人們理解框架,然後我可以將季節性作為其中的一部分。

  • So first off, from a total company perspective, as we talked about in that 20% plus range very consistent with our messaging to close out last year and early this year at JPM, where we updated our corporate presentation and thinking for this year and in 2025. Importantly, as part of that question, we're using the same framework we use last year. Obviously a higher starting point for the Company and both franchises. So it is a bit higher, but same framework, which is important. And so I may see and I'll touch on the seasonality. So we may see from a framework perspective, again, it's very similar to 2023 which is starting the year, assuming our key growth drivers are surging continued surging growth, which has been strong, that leads to additional biopsies and volumes and increase in price. So that gets you into the call it high 10s on a full year basis. And so as part of your question, I would say we factored in some impact of the arthroscopic launch it's really more, I would say, from a Q4 perspective. But I wouldn't say that meaningfully changes kind of how we're thinking about seasonality from a seat perspective.

    首先,從整個公司的角度來看,正如我們在20% 以上的範圍內所討論的那樣,這與我們去年和今年年初在摩根大通的信息非常一致,我們更新了今年和今年的公司演示和想法. 2025 年。重要的是,作為這個問題的一部分,我們使用的是去年使用的相同框架。顯然,公司和兩家特許經營公司的起點更高。所以它有點高,但框架相同,這一點很重要。所以我可能會看到並且會談到季節性。因此,我們可能會再次從框架的角度來看,這與年初的 2023 年非常相似,假設我們的主要成長動力是持續強勁的成長,這會導致更多的活檢和數量以及價格上漲。這樣你就可以在全年的基礎上進入前十名。因此,作為你問題的一部分,我想說,我們考慮了關節鏡發布的一些影響,我想說,從第四季度的角度來看,這確實是更多的影響。但我不會說這會有意義地改變我們從座位角度思考季節性的方式。

  • So yes, it certainly could have some impact because we do think ours will have an impact in Q4. But to start, I wouldn't think from a quarterly perspective, it will be significant relative to last year and kind of what an aperture books. So if you think about MACI and we talked about in the prepared remarks, I think a good place to start. We're not giving formal product guidance, but we did want to touch on kind of our framework across the franchise. And so yes, if you assume maybe kind of in that high teens as we talked about, which was higher than our starting point for last year. That gets you in the kind of low to mid one 90s on a full year basis. So for example, if you use kind of 18% or $194 million, that would kind of lead to burn care, which the balance at our midpoint would be about $45 million. And so from a very fair perspective, and then I'll tie in the seasonality as part of this, I think that would certainly be pretty strong growth in slide 30%, more than 30% at that midpoint and call it 45%.

    所以,是的,它肯定會產生一些影響,因為我們確實認為我們的影響將在第四季度產生影響。但首先,我不認為從季度的角度來看,這相對於去年來說會很重要,也不會像光圈書那麼重要。因此,如果您考慮我們在準備好的演講中討論過的 MACI,我認為這是一個很好的起點。我們沒有提供正式的產品指導,但我們確實想談談我們整個特許經營的框架。所以,是的,如果你假設可能是我們所說的十幾歲,這比我們去年的起點要高。這會讓你全年處於 90 年代中低水準。例如,如果您使用 18% 或 1.94 億美元,這將導致燒傷護理,我們的中點餘額約為 4500 萬美元。因此,從非常公平的角度來看,然後我將把季節性作為其中的一部分,我認為下滑 30% 肯定會相當強勁,在中點超過 30%,稱之為 45%。

  • And again, I think what's really important is a couple of things. One, there's certainly a range of possibilities across the product. So we don't know exactly what that's going to look quite cross Epicel and NexoBrid. Again, we're not giving specific product guidance, but we'll talk a little bit about framework. But I think to that framework perspective and again, very similar to last year, which is we came out of '22 a year ago and said, we think we can grow our episode run rate off that exit rate. Our expectation is kind of the same this year. So last year, if you remember, we were coming out of the out of the year kind of, call it, $6 million to $7 million run rate range on Epicel. And actually, if you look back at where we ended '23, our run rate in the last three quarters was more like, call it $8 million-plus, around $8.3 million. So our exit rate on Epicel is actually really a $33 million number, and we certainly think it's reasonable to grow that number. So last year, we grew that extra rate over 20% and even more if you assume the starting point for like $6 million. And prior to COVID on episode, we generally grew in kind of the 20% range. So our expectation and Epicel obviously can vary from quarter to quarter but from a full-year perspective, we certainly think it's reasonable to again assume, call it low double digit growth. And importantly, we're seeing a higher share of voice. We had a strong Q4 and sort of the biopsies and part of that equation is increase in price. We do take price increases on Epicel. So it's certainly reasonable to expect, I think low double digits, which would be lower than last year and lower than pre-COVID years from relative to the exit rate on Epicel.

    再說一次,我認為真正重要的是幾件事。第一,該產品肯定存在一系列可能性。所以我們並不確切知道 Epicel 和 NexoBrid 的效果如何。同樣,我們不會提供具體的產品指南,但我們會討論一些框架。但我認為從這個框架的角度來看,與去年非常相似,我們一年前從《22》中出來並表示,我們認為我們可以在退出率的基礎上提高我們的劇集播放率。今年我們的期望是一樣的。所以去年,如果你還記得的話,我們在 Epicel 上走出了 600 萬至 700 萬美元的年度運行率範圍。事實上,如果你回顧我們 23 年結束的情況,我們過去三個季度的運行率更像是 800 萬美元以上,大約 830 萬美元。因此,我們在 Epicel 上的退出率實際上是 3300 萬美元,我們當然認為增加這個數字是合理的。所以去年,我們將額外費率提高了 20% 以上,如果假設起始價為 600 萬美元,甚至更高。在新冠疫情爆發之前,我們的成長率通常在 20% 左右。因此,我們的預期和 Epicel 顯然每個季度都會有所不同,但從全年的角度來看,我們當然認為再次假設「低兩位數成長」是合理的。重要的是,我們看到了越來越多的聲音。我們在第四季表現強勁,進行了一些活檢,其中一部分就是價格上漲。我們確實接受了 Epicel 的漲價。因此,我認為低兩位數的預期當然是合理的,相對於 Epicel 的退出率,這將低於去年,也低於新冠疫情之前的幾年。

  • So obviously, from a seasonality perspective there, as you know, well, that can vary quarter to quarter, but we think from a full year perspective, that's probably a pretty good place to start. So if you assume that, for example, call it low double digit or double-digit Rainier kind of probably the starting point is, I think a good scenario scenarios cause $37 million to $38 million, for example. So in that scenario, NexoBrid would be in that $7 million to $8 million range. And clearly, NexoBrid, obviously very early in the launch and still difficult to predict the absolute number, let alone the quarterly numbers we have not given any specific guidance today on 2024, and that's still difficult. Obviously, a few months and a few weeks into our quarter added a few weeks of the launch, but we would expect kind of progression throughout the year by NexoBrid. So again, Epicel can vary a bit, as we know from quarter to quarter you I think it's safe to assume that NexoBrid will continue to build during the year. So there will be a degree of seasonality, certainly in NexoBrid on, but just to bring it back, I wouldn't assume anything materially different on may see again, episodic typical quarterly volatility.

    顯然,從季節性的角度來看,正如你所知,每個季度的情況可能會有所不同,但我們認為從全年的角度來看,這可能是一個很好的起點。因此,如果你假設,例如,稱之為低兩位數或兩位數雷尼爾,可能的起點是,我認為一個好的場景會導致 3700 萬美元到 3800 萬美元,例如。因此,在這種情況下,NexoBrid 的價格將在 700 萬至 800 萬美元之間。顯然,NexoBrid 顯然還處於發布初期,仍然很難預測絕對數字,更不用說季度數字了,我們今天還沒有對 2024 年給出任何具體指導,這仍然很困難。顯然,在本季度的幾個月和幾週後,我們又增加了幾週的發佈時間,但我們預計 NexoBrid 全年都會取得進展。再說一遍,Epicel 可能會有所不同,正如我們每個季度都知道的那樣,我認為可以安全地假設 NexoBrid 將在今年繼續建造。因此,會有一定程度的季節性,當然在 NexoBrid 中,但只是為了將其帶回來,我不認為可能會再次出現任何重大不同,即週期性的典型季度波動。

  • Ryan Zimmerman - Analyst

    Ryan Zimmerman - Analyst

  • Thank you for all that color. That's very appreciative. Maybe just to ask on NexoBrid, you know, I think people were hoping it would kind of get rolling pretty quickly here. You're guiding to kind of a similar level from the fourth quarter. Talk to us about kind of, you know, how the process is going? I mean, clearly there's interest you wouldn't have that many sites ordering this early, if there wasn't. But you know, how do you thinking about kind of the early adoption of NexoBrid from what you're seeing so far, you know, couple of weeks of the launch. Thanks for taking the questions.

    謝謝你所有的顏色。非常感謝。也許只是想問 NexoBrid,你知道,我認為人們希望它能在這裡快速發展。從第四季度開始,您將達到類似的水平。和我們談談這個過程進展如何?我的意思是,如果沒有的話,顯然不會有那麼多網站這麼早就訂購。但你知道,從你到目前為止所看到的情況(發布幾週後)來看,你如何看待 NexoBrid 的早期採用。感謝您提出問題。

  • Nick Colangelo - CEO, President & Director

    Nick Colangelo - CEO, President & Director

  • Yes, hey, Ryan, this is Nick. I'll start and then Joe can kind of talk about sort of the dynamics of the distribution system. But you know, from our perspective, as you referenced, whether it's our market research or independent work that others have done. I mean, there is this high level of interest from surgeons in NexoBrid. There's no doubt about that. And, you know, obviously, we the team has done a great job on in terms of the onboarding of burn centers.

    是的,嘿,瑞安,這是尼克。我先開始,然後喬可以談談分銷系統的動態。但你知道,從我們的角度來看,正如你所提到的,無論是我們的市場研究還是其他人所做的獨立工作。我的意思是,外科醫生對 NexoBrid 非常感興趣。毫無疑問。而且,你知道,顯然,我們團隊在燒傷中心的入職方面做得很好。

  • And, you know, we'll continue to keep adding those burn centers with the delay last year. You know, there was an interruption to sort of the on boarding process for many centers when the product did become available. Obviously, those that were farther along were able to kind of finish out that process and start making some initial orders.

    而且,你知道,我們將繼續在去年推遲的情況下繼續增加這些燒傷中心。您知道,當產品可用時,許多中心的入職流程都會中斷。顯然,那些走得更遠的人能夠完成這個過程並開始製作一些初始訂單。

  • And with respect to other centers where they had really kind of put things on hold, you know, it was a reengagement progress process and all of that is going really well. Obviously Importantly, we think about this. Obviously, as we've always said, over the long term, we are changing the standard of care for what burn surgeons have done for the last several decades in terms of their eschar removal protocols, et cetera, and those things take time, but making great progress.

    相對於其他中心,他們確實把事情擱置了,你知道,這是一個重新參與的過程,所有這些都進展順利。顯然重要的是,我們考慮了這一點。顯然,正如我們一直所說的那樣,從長遠來看,我們正在改變燒傷外科醫生過去幾十年在焦痂去除方案等方面所做的護理標準,而這些事情需要時間,但是取得長足進步。

  • And importantly, we take great care to make sure we support the initial patient applications and treatments. The outcomes have been great. The surgeons' feedback has been great. So, you know, we think we're, you know, kind of where we thought we'd be and sort of making the progress that we would expect.

    重要的是,我們非常謹慎地確保支持最初的患者申請和治療。結果非常好。外科醫生的回饋非常好。所以,你知道,我們認為我們已經達到了我們的預期,並且取得了我們預期的進展。

  • Joseph Mara - CFO & Treasurer

    Joseph Mara - CFO & Treasurer

  • Yeah. Just maybe just to add a little bit on site as well on the export side. So first, as Nick said, the metrics have been very strong to start. The clinical feedback has been very positive. So those are great signals. I think it is important to understand. We're early in the launch.

    是的。也許只是在現場以及出口方面添加一點。因此,正如尼克所說,首先,指標一開始就非常強勁。臨床反饋非常正面。所以這些都是很好的訊​​號。我認為理解這一點很重要。我們還處於發布初期。

  • And a couple of things just to point out, which is, again, the distribution on NexoBrid is very different than safety and Epicel. And as a reminder, we have a 3PL and kind of managed our inventory. And then the distribution network that's in place consists of multiple specialty distributors, some have multiple locations, and we recognize revenue when those specialty distributors order from our 3PL.

    有幾件事需要指出,NexoBrid 上的分佈與安全性和 Epicel 上的分佈有很大不同。提醒一下,我們有一個 3PL,並且可以管理我們的庫存。然後,現有的分銷網絡由多個專業分銷商組成,其中一些擁有多個地點,當這些專業分銷商從我們的 3PL 訂購時,我們將確認收入。

  • The second kind of part of the channel, if you will, is then the burn centers and hospitals order from those that feel like the one that they typically work work with most likely for some different products sufficient at their centers. So when they order that drives additional orders from RSC each quarter and then leads to a quarterly revenue. And then lastly, it's important to remember that both the SD in the hospitals will keep some level of inventory which can which can vary and impact ordering patterns.

    如果你願意的話,該管道的第二種部分是燒傷中心和醫院從那些感覺像是他們通常合作的人那裡訂購的產品,很可能在他們的中心提供一些足夠的不同產品。因此,當他們訂購時,每季都會從 RSC 獲得更多訂單,然後產生季度收入。最後,重要的是要記住,醫院的 SD 都會保留一定程度的庫存,這可能會有所不同並影響訂購模式。

  • So just briefly, as you kind of think about the first couple of quarters, the launch again, Q3, that was yes, if you remember two, three week commercial ability better availability very late in the quarter. So that was essentially the ST's kind of ordering from a channel perspective in three. And we didn't really get into the market and start treating patients. So Q4, that's the quarter where hospitals start ordering from SC and kind of it's in the market, et cetera?

    簡而言之,當您考慮前幾季度時,再次發布,第三季度,是的,如果您還記得本季度末兩三週的商業能力更好的可用性。因此,從渠道角度來看,這本質上是 ST 的三項排序。我們並沒有真正進入市場並開始治療患者。那麼第四季度,醫院開始從 SC 訂購並進入市場,等等?

  • In general, I think what we've seen is a lot of the burn centers that were more physician or sorry, more. I'm more familiar with NexoBrid, some of the burn surgeon KOLs as well as the hospitals that were farther along in the P&T process even when things were disrupted last year. So I would say it was as anticipated. That means that essentially from initial stocking at hospitals now as we get into Q1, we're seeing continued use on patients.

    總的來說,我認為我們所看到的是許多燒傷中心的醫生更多,或者抱歉,更多。我更熟悉 NexoBrid、一些燒傷外科醫生 KOL 以及在 P&T 流程中走得更遠的醫院,即使去年情況受到干擾。所以我想說這正如預期的那樣。這意味著,從本質上講,從醫院最初的庫存開始,進入第一季度,我們看到患者繼續使用該藥物。

  • We're seeing some of those hospitals start to use that inventory that can then lead to some reorders. And at the same time, as Nick mentioned, the team is working to add new centers on top of the ones that have already ordered and working through some of those administrative challenges at the burn centers so I think as these dynamics play out, particularly early in the launch, it's going to take some time for ordering patterns to normalize at both the ST and the hospitals which is which is anticipated, I would say, kind of this point in the launch.

    我們看到其中一些醫院開始使用這些庫存,從而導致一些重新訂購。同時,正如尼克所提到的,該團隊正在努力在已經訂購的中心之上增加新的中心,並解決燒傷中心的一些管理挑戰,所以我認為隨著這些動態的發揮,特別是早期在發布過程中,ST 和醫院的訂購模式需要一些時間才能正常化,我想說,這就是發布過程中的這一點。

  • And lastly, again, we have one quarter of history and thought and until a few weeks left in Q1. And again, unlike maybe an episode where the kind of history and data, we won't know exactly what those at the orders look like until we get later in the quarter. And so there's a whole range of outcomes outside of off-air.

    最後,我們還有四分之一的歷史和思想,直到第一季還剩幾週。再說一遍,與歷史記錄和數據的情況不同,我們要等到本季晚些時候才能確切知道訂單中的內容是什麼樣子。因此,在停播之外還有各種各樣的結果。

  • Ryan Zimmerman - Analyst

    Ryan Zimmerman - Analyst

  • Thanks, guys, for the very comprehensive answers. Appreciate it.

    謝謝你們提供了非常全面的答案。欣賞它。

  • Operator

    Operator

  • Mike Kratky, Leerink Partners LLC

    Mike Kratky,Leerink Partners LLC

  • Mike Kratky - Analyst

    Mike Kratky - Analyst

  • Hi, everyone, thanks for taking the questions. Can you speak to how you're thinking about how quickly you can get traction in the new target surgeon population once you get arthroscopic approval, I mean, can you get a sense there's pent-up demand from surgeons that are not currently using may see presently, but we'll start doing implants once you have arthroscopic approval?

    大家好,感謝您提問。您能否談談您如何考慮,一旦您獲得關節鏡批准,您可以多快地吸引新的目標外科醫生群體,我的意思是,您是否能感覺到目前尚未使用關節鏡的外科醫生存在被壓抑的需求?目前,但是一旦您獲得關節鏡批准,我們就會開始進行植入?

  • Nick Colangelo - CEO, President & Director

    Nick Colangelo - CEO, President & Director

  • Yes, hey, Mike, this is Nick. Um, you know, obviously, as we said, we're really excited about May CR for the reasons we've described. It's the look, you know, targets to larger center segment of our addressable market would be the only arthroscopic restorative cartilage repair procedure for these femoral condo defects of a certain size. So we think and this is going to be very meaningful for us as we move forward. Obviously, we can't at this point since it's not an approved method of administration be out there talking generally to surgeons, but we are working with a couple of dozen surgeons through the human factor study, Voice of the Customer Labs additional trainings, et cetera. And I'll just say the enthusiasm from the surgeons who have been exposed to the new instruments has been significant and Great. So they're really excited about it and I would expect that that will translate to those who aren't as familiar with it right now.

    是的,嘿,麥克,這是尼克。嗯,你知道,顯然,正如我們所說,出於我們所描述的原因,我們對 5 月 CR 感到非常興奮。你知道,它的目標是我們可尋址市場的更大的中心部分,這將是針對這些一定大小的股骨公寓缺陷的唯一關節鏡恢復性軟骨修復手術。所以我們認為,隨著我們的前進,這對我們來說非常有意義。顯然,我們目前還不能,因為這不是一種經過批准的管理方法,可以與外科醫生進行一般性交談,但我們正在透過人為因素研究、客戶之聲實驗室額外培訓等與數十名外科醫生合作等等。我只想說,接觸過新器械的外科醫生的熱情是巨大而偉大的。所以他們對此感到非常興奮,我希望這會轉化為現在不熟悉它的人。

  • And I would just last point would be that, you know, for the surgeons if you look at our addressable market right now, the vast majority of cartilage repair procedures are done arthroscopic lease, whether it's condo place, these microfracture, those are the things that make up the majority of the cartilage repair market. So this kind of is right in the wheelhouse for those surgeons in terms of how they currently do their cartilage repair procedures and there's nothing out there that has the clinical outcomes that may see has. So we think that combination is going to be very powerful for us as we move forward.

    我想說的最後一點是,對於外科醫生來說,如果你看看我們現在的潛在市場,絕大多數軟骨修復手術都是透過關節鏡租賃完成的,無論是公寓房,這些微骨折,這些都是這些佔軟骨修復市場的大部分。因此,對於那些外科醫生目前如何進行軟骨修復手術而言,這種方法是正確的,而且沒有任何東西可以達到臨床效果。因此,我們認為,隨著我們的前進,這種結合對我們來說將非常強大。

  • Mike Kratky - Analyst

    Mike Kratky - Analyst

  • Got it. Yes, I really appreciate the color there. And then maybe just as a follow-up, is it reasonable to think that as you get arthroscopic approval that could ultimately lead to an improvement in the conversion rate just as more implants end up getting done over time with that available?

    知道了。是的,我真的很欣賞那裡的顏色。然後也許只是作為後續行動,是否合理地認為,當您獲得關節鏡批准時,最終可能會導致轉換率的提高,就像隨著時間的推移,更多的植入物最終會隨著可用的植入物而完成?

  • Nick Colangelo - CEO, President & Director

    Nick Colangelo - CEO, President & Director

  • Yes, we certainly believe in our surgeons believe that number one, you know, with a less invasive procedure that you know, obviously, there's better aesthetic outcomes. There's less postoperative pain and we would expect there to be and we feel faster post surgical recoveries. And that is something from a medical affairs perspective that will be focused on as soon as we launch the product and generating data that actually supports what I think everybody expects to be the case. So yes, I think that that is very much in line and sort of what we're thinking.

    是的,我們當然相信我們的外科醫生相信,第一,你知道,透過侵入性較小的手術,你知道,顯然會有更好的美容效果。術後疼痛減輕了,這是我們所期望的,而且我們感覺術後恢復更快。這是從醫療事務角度來看的,一旦我們推出產品並產生實際上支持我認為每個人都期望的情況的數據,我們就會專注於這一點。所以,是的,我認為這非常符合我們的想法。

  • Mike Kratky - Analyst

    Mike Kratky - Analyst

  • Got it. Thanks very much.

    知道了。非常感謝。

  • Nick Colangelo - CEO, President & Director

    Nick Colangelo - CEO, President & Director

  • Thanks, Mike.

    謝謝,麥克。

  • Operator

    Operator

  • Richard [Neweter], Truist Securities.

    理查德 [Neweter],Truist 證券公司。

  • Samuel Brodovsky - Analyst

    Samuel Brodovsky - Analyst

  • Hey, sorry, it's actually Sam on. Thanks for taking the questions. Just first one on MACI's Can you just sort of walk us through the price dynamic in 2023 and then and any changes there are for 2024? And how should we be thinking about that impacting revenue and any price impact from arthroscopic as well?

    嘿,抱歉,其實是 Sam。感謝您提出問題。這是 MACI 的第一個,您能否向我們介紹 2023 年的價格動態以及 2024 年的價格動態?我們應該如何考慮這對收入的影響以及關節鏡對價格的影響?

  • Nick Colangelo - CEO, President & Director

    Nick Colangelo - CEO, President & Director

  • Yes. Hey, Sam, this is Nick. So yes, so we've spoken before about sort of we routinely take annual price increases for may see. We of course, expect to do that this year as well. We've typically taken a mid-year price increase. The with respect to arthroscopic may see MACI's RemX, the product itself obviously is reimbursed under a J code that pricing will not change whether a surgeon deliveries may see is in a mini, our throttle me or an arthroscopic procedure. So so that will have impacted the CPT codes.

    是的。嘿,山姆,這是尼克。所以是的,我們之前已經談到過我們通常會考慮每年的價格上漲。當然,我們希望今年也能做到這一點。我們通常會在年中漲價。就關節鏡手術而言,可以看到MACI 的RemX,該產品本身顯然是根據J 代碼報銷的,無論外科醫生交付的手術是迷你型、我們的節流術還是關節鏡手術,定價都不會改變。所以這將會影響 CPT 代碼。

  • That target is the same. So the be the reimbursement or for the surgeon will be the same for the procedure. We do anticipate charging. This will be a disposable set of instruments and we do expect to charge for those instruments. So, you know, much like RBC biopsy kits where there's a line item in our financial filings that you can see, we expect that these instruments will generate some revenue for the Company and offset some other costs potentially over time. But you know, really the main revenue driver is the reimbursement for the implant itself.

    這個目標是一樣的。因此,手術的報銷或外科醫生的費用將是相同的。我們確實預計會充電。這將是一套一次性儀器,我們確實希望對這些儀器收費。因此,您知道,就像紅血球活檢套件一樣,您可以在我們的財務文件中看到一個行項目,我們預計這些工具將為公司帶來一些收入,並隨著時間的推移可能抵消一些其他成本。但你知道,真正的主要收入來源是植入物本身的報銷。

  • Samuel Brodovsky - Analyst

    Samuel Brodovsky - Analyst

  • Thanks, Ryan, and thanks for all the really detailed color earlier those really helpful. I did just want to touch a little more on EpiCept, given the quarterly volatility this product can have. Can you just give us a little more insight into what the visibility you have into that sort of run rate through the year and why you're so confident again?

    謝謝瑞安,感謝之前提供的所有非常詳細的顏色,這些非常有幫助。考慮到該產品的季度波動性,我只是想多接觸一下 EpiCept。您能否讓我們更深入地了解一下您對全年運行率的了解以及您為何再次如此自信?

  • Nick Colangelo - CEO, President & Director

    Nick Colangelo - CEO, President & Director

  • Yes, I'll start and Joe can Kevin and John chime in. I think Joe referenced in the prepared remarks that you know historically and pre COVID. I mean, things got a little, you know, more variable during COVID, obviously. And yes, we would always say it's probably safe place to start the year, assuming high single digit to low double digit growth for Epicel. We kind of routinely outperformed that. But again, given sort of less visibility than we have, for instance, we may see we kind of always just assume that you don't kind of communicate communicated. I should say that that was a good place to start. And, you know, I would say that over the past essentially three quarters now, you know, Epicel with a large larger share of voice has been sort of returning.

    是的,我先開始,喬可以,凱文和約翰插話。我認為喬在準備好的演講中提到了您在歷史和新冠疫情之前就知道的情況。我的意思是,顯然,在新冠疫情期間,情況變得更加多變。是的,我們總是會說,假設 Epicel 實現高個位數到低兩位數的成長,那麼今年開始可能是安全的。我們的表現通常都超過了這一點。但同樣,考慮到比我們更少的可見性,例如,我們可能會發現我們總是假設你沒有進行溝通。我應該說這是一個很好的起點。而且,我想說的是,在過去的四分之三裡,擁有更大份額的 Epicel 已經回歸了。

  • It's not even back to its highest levels ever. And even though we've seen it kind of get back to routinely into more like an eight plus million run rate. And you know, the markets kind of normalize the we had some dynamics with respect to our largest customer that have now been resolved at their facility, not episode related, but other issues. And so all of that is kind of normalized. And so we're kind of back into reserve at that that place we were in it from prior years.

    它甚至還沒有回到有史以來的最高水平。儘管我們已經看到它通常會恢復到更像八百萬的運行率。你知道,市場有點正常化,我們與我們最大的客戶有一些動態,這些動態現在已經在他們的工廠解決,不是與事件相關,而是其他問題。所以這一切都已經正常化了。因此,我們又回到了前幾年所處的位置。

  • And so again, it, you know, obviously, we have what we have a biopsy quarter like we did in the fourth quarter. We know that's going to create strength into the year as we discussed earlier. So so yes, we're feeling pretty good about it. And again, we said all along that we expected pull through for Epicel from having a larger share of voice were in more hospitals than we were previously in all that had an impact starting kind of the middle of last year as we talked about on earlier calls, and it continues to have an impact.

    再說一次,你知道,顯然,我們有一個活檢季度,就像我們在第四季度所做的那樣。我們知道,正如我們之前討論的那樣,這將為今年創造力量。所以是的,我們對此感覺很好。再說一次,我們一直說過,我們預計Epicel 會成功,因為我們在更多的醫院中擁有比我們之前更多的話語權,這從去年年中開始就產生了影響,正如我們在之前的電話會議中談到的那樣,並且其影響仍在繼續。

  • Joseph Mara - CFO & Treasurer

    Joseph Mara - CFO & Treasurer

  • Yes, just to add, yes, just to kind of reiterate or add a little bit into kind of the earlier question around seasonality tied into it and guidance, et cetera. But I think it is important to recognize the app itself meaningfully grew on versus where it exited at '22. So that's it's a little bit tough to look at calendar years, but we know is running in the $6 million to $7 million range again, if you just use the last couple of quarters of '22, it was kind of high sixes. Now we're above a I mean, that's more than 20% growth, which also lined up historically to kind of where we were.

    是的,只是補充一點,是的,只是重申或添加一點關於與它相關的季節性和指導等的早期問題。但我認為重要的是要認識到該應用程式本身的發展與 22 年退出時的情況相比是有意義的。因此,查看日曆年有點困難,但我們知道再次在 600 萬美元到 700 萬美元的範圍內運行,如果你只使用 22 年的最後幾個季度,那就是高分。現在我們的成長率超過了 20%,這也與我們的歷史水準相符。

  • And again, as we think about kind of growth on a full year basis, just to reiterate, there's multiple components there. So we think the volume can be a bit better, and we're starting to see some signs of that with a larger footprint and the share of voice. But also, as I said, earlier, there's a price component in there as well. So as you think about, call it, low double digit growth and Epicel and again, that's one scenario within our guidance in burn care. There can be shifts, London franchise products. But the one I referenced I mean, that's below where we were last year on. So I certainly think that's a reasonable expectation. Again, it can vary quarter to quarter in terms of how we get there. But we think that's certainly a reasonable why inflation going into the year.

    再次,當我們考慮全年的成長時,重申一下,其中有多個組成部分。因此,我們認為音量可以更好一點,我們開始看到一些跡象,即更大的足跡和語音份額。但正如我之前所說,其中也有價格因素。因此,正如您所想的那樣,稱之為低兩位數增長和 Epicel,這也是我們燒傷護理指南中的一種情況。可以有班次,倫敦專營產品。但我提到的那個,我的意思是,它低於我們去年的水平。所以我當然認為這是一個合理的期望。同樣,我們實現這一目標的方式每個季度都會有所不同。但我們認為這當然是今年通膨的合理原因。

  • Samuel Brodovsky - Analyst

    Samuel Brodovsky - Analyst

  • Great.

    偉大的。

  • Operator

    Operator

  • George Sellers, Stephens Inc.

    喬治·塞勒斯,史蒂芬斯公司

  • George Sellers - Analyst

    George Sellers - Analyst

  • Hey, good morning and thanks for taking the question. Maybe to shift gears a little bit to the margin guidance. I'm just curious, what does that assume in terms of the improvement driven by price versus NexoBrid and Epicel ramping up? And then what's also sort of assumed related to investment for commercializing arthroscopic delivery?

    嘿,早上好,感謝您提出問題。也許會稍微調整一下利潤指引。我只是很好奇,與 NexoBrid 和 Epicel 的上漲相比,價格推動的改善是怎樣的假設?那麼與關節鏡分娩商業化投資相關的假設又是什麼呢?

  • Joseph Mara - CFO & Treasurer

    Joseph Mara - CFO & Treasurer

  • Yes. Good morning, George, and thanks for the question. So I'll kind of hit that and make sure we talk a little bit about some of the guidance on the on the revenue piece. So as we talked about, we're expecting improvement in gross margin from high 60s last year to 70s adjusted EBITDA. We ended last year on a full-year basis at 17, we think we can be around that 20% number this year.

    是的。早安,喬治,謝謝你的提問。因此,我會談到這一點,並確保我們討論一些關於收入部分的指導。正如我們所討論的,我們預計毛利率將從去年的 60 多美元調整後 EBITDA 提高到 70 多美元。去年全年我們的數字為 17,我們認為今年可以達到 20% 左右。

  • First off, I'd just kind of point out I did I did comment in my prepared remarks. But as you think about that guidance, I would say it's also important to think about the quarterly progression and the trends there. So you know, the way it kind of our business works with just some of the seasonality and whatnot as we typically see improving kind of margins throughout the year, particularly Q1 top, it ends up being kind of on the low end. And then Q4 obviously ends up being on the higher end. So there's going to be a progression, I would say, and you can really reference last year's trajectory and assume possibly on something similar on a year-over-year basis, there was improvement and they can obviously be some puts and takes within quarters.

    首先,我想指出我確實在準備好的發言中發表了評論。但當您考慮該指導時,我想說,考慮季度進展和趨勢也很重要。所以你知道,我們的業務方式與一些季節性因素以及其他因素有關,因為我們通常會看到全年利潤率有所提高,特別是第一季的頂部,但它最終會處於低端。然後第四季顯然最終會處於高端。因此,我想說,將會有一個進步,你可以真正參考去年的軌跡,並假設可能在同比的基礎上出現類似的情況,有所改善,而且顯然可以在幾個季度內進行一些調整。

  • In terms of kind of what's driving kind of the margin improvement I would say on. And I guess on the last piece on the OpEx side, just before I go there, we did talk about, call it, mid 160s. I think I mentioned 165 from an OpEx perspective. And from an investment perspective, it's the things we've been talking about. So certainly we'll want to make sure our throw it set up for success.

    就推動利潤率改善的因素而言,我想說的是。我想在 OpEx 方面的最後一篇文章中,就在我去那裡之前,我們確實討論過,稱之為 160 年代中期。我想我是從營運支出的角度提到了 165。從投資的角度來看,這就是我們一直在談論的事情。因此,我們當然希望確保我們的投擲設定能夠成功。

  • Yes, there's some spend there to kind of get ready from a commercial perspective to make sure the instruments are ready. So that is clearly a priority investment this year to make sure that it's successful.

    是的,從商業角度來看,需要花費一些資金來做好準備,以確保儀器準備就緒。因此,這顯然是今年的優先投資,以確保其成功。

  • And then things like Angola from a lifecycle management and other investments, just there by more modest, but you have to make sure things like that, Sabrina or kind of bomb continue to track. So those remain the investment areas are certainly are on our leverage broadly is driven by the top line, you know, growth being sustained at a high level. We certainly want to make sure we manage our OpEx growth, but at a lower level than that and we did that last year. And that's certainly our plan this year.

    然後像安哥拉這樣的生命週期管理和其他投資,只是比較溫和,但你必須確保像薩布麗娜或類似炸彈這樣的事情繼續跟踪。因此,這些投資領域肯定是在我們的槓桿作用下,總體上是由營收驅動的,你知道,成長保持在高水準。我們當然希望確保我們管理我們的營運支出成長,但水準低於我們去年所做的。這當然是我們今年的計畫。

  • In terms of kind of what flows through to the margin you have, certainly, as we talked about NexoBrid kind of fits into the margin profile from a gross margin perspective. So that's helpful. And then some of that to your question, obviously, as you take the increase in price that it certainly helps from a gross margin perspective, but there's also just some natural leverage in the business. And I think we're starting to see where, again, if we can kind of manage our costs at a lower level value overall revenue. We're going to see that pull through.

    就流向利潤的情況而言,當然,正如我們所討論的,從毛利率的角度來看,NexoBrid 有點適合利潤狀況。所以這很有幫助。然後,對於你的問題,顯然,當你考慮價格上漲時,從毛利率的角度來看,這肯定會有所幫助,但業務中也存在一些自然的槓桿作用。我認為我們再次開始考慮,如果我們能夠在較低的總收入水平上管理我們的成本。我們將看到這一點得以實現。

  • And then lastly, I talked about in the prepared remarks, but you can also see we also talk about pull through in terms of how much is dropping to the bottom line. I think if you look at Q4 last year and you know what that was really strong and the adjusted EBITDA line pulled through on the gross margin, both Q4 and full year kind of in that 80% range. So I think that's kind of where it is where it needs to be last year and something we're focused on maintaining this year.

    最後,我在準備好的發言中談到了這一點,但你也可以看到我們也討論了到底線下降了多少。我認為,如果你看看去年第四季度,你就會知道真正強勁的是什麼,調整後的 EBITDA 線在毛利率上實現了增長,第四季度和全年都在 80% 的範圍內。所以我認為這就是去年需要達成的目標,也是我們今年重點維護的目標。

  • George Sellers - Analyst

    George Sellers - Analyst

  • Okay. That's really helpful color. I appreciate all that detail. You touched on MACI. They see a goal. I'm just curious with that clinical study initiating in 2025, and then you've also talked about getting close to 30% adjusted EBITDA margins in 2025 and beyond, how do we sort of reconcile those two items? What should we think about in terms of the investments for launch in that clinical trial?

    好的。這真是有用的顏色。我很欣賞所有這些細節。你提到了 MACI。他們看到了一個目標。我只是對 2025 年啟動的臨床研究感到好奇,然後您還談到了在 2025 年及以後調整後的 EBITDA 利潤率接近 30%,我們如何協調這兩項?在啟動該臨床試驗的投資方面我們應該考慮什麼?

  • Nick Colangelo - CEO, President & Director

    Nick Colangelo - CEO, President & Director

  • Hey, George, Nick, Vito, as we've talked about, some of this study has always been sort of play in is included in sort of the long term longer-term projections that we've given. This is not a you know, large study by pharma or biotech standards, you know it very much like the SUMMIT study that was the pivotal study for MACI the need, you know, somewhere call it up around 200 patients. It will take a couple of years to roll. And so, you know, it's kind of single digit million kinds of study. And so, you know, it's again not compared to our overall sort of OpEx and investment. It's really not that significant.

    嘿,喬治,尼克,維托,正如我們所討論的,這項研究的一些內容一直被包含在我們給出的長期預測中。這不是一項按製藥或生物技術標準進行的大型研究,您知道它非常像 SUMMIT 研究,該研究是 MACI 的關鍵研究,您知道,在某個地方將其稱為大約 200 名患者。滾動需要幾年時間。所以,你知道,這是一種數百萬種的研究。所以,你知道,它又沒有與我們整體的營運支出和投資進行比較。這確實沒有那麼重要。

  • George Sellers - Analyst

    George Sellers - Analyst

  • That's significant. Okay, great. Thank you all again for the time.

    這很重要。好的,太好了。再次感謝大家抽出時間。

  • Nick Colangelo - CEO, President & Director

    Nick Colangelo - CEO, President & Director

  • All right. Thank you.

    好的。謝謝。

  • Operator

    Operator

  • Jeff Cohen, Ladenburg Thalmann

    傑夫‧科恩、拉登堡‧塔爾曼

  • Jeff Cohen - Analyst

    Jeff Cohen - Analyst

  • Please go ahead for our near can go. You can well imagine couple quick ones from me. And so when you talk about MACI's or throw in the OR, the surgeon population expanding out from 5,000 to 7,000, how do we equate that and think about the overall TAM as there's certainly some other levers out there at a 40% greater TAM or one way we think.

    請繼續,因為我們附近可以去。你完全可以想像我的幾個快速的。因此,當您談論 MACI 或放入手術室時,外科醫生人數從 5,000 人擴大到 7,000 人,我們如何將其等同並考慮總體 TAM,因為肯定還有其他一些槓桿可以使 TAM 提高 40% 或一個我們的想法。

  • Nick Colangelo - CEO, President & Director

    Nick Colangelo - CEO, President & Director

  • Yes. So as we talked about previously, when you look at our 60,000 patient TAM. Clearly, MACI's, I go to product and patella and larger defects on the femoral con dial or other areas of the knee. And, you know, we do get business on these two to four square centimeter defects in the femoral Cannondale. But just our penetration rate there is lower and we think makes the arthroscopic will allow us to have deeper penetration there.

    是的。正如我們之前談到的,當你看到我們的 60,000 名患者 TAM 時。顯然,MACI,我會去產品和髕骨以及股骨錐盤或膝蓋其他區域的較大缺陷。而且,你知道,我們確實在股骨 Cannondale 的這些兩到四平方厘米的缺陷上獲得了業務。但只是我們在那裡的滲透率較低,我們認為關節鏡將使我們在那裡有更深的滲透。

  • So for MACI Arthro it's really about sort of deeper penetration into the existing addressable market of $3 billion plus the TAM expansion for me see occurs when you move to other joints. And that's where we see April comes into play. And as I mentioned in my prepared remarks, you know, that's about a $1 billion addressable market opportunity for us with around 20,000 eligible patients per year.

    因此,對於 MACI Arthro 來說,它實際上是要更深入地滲透到現有的 30 億美元的潛在市場,加上我認為當你轉向其他關節時就會出現 TAM 擴張。這就是我們看到四月發揮作用的地方。正如我在準備好的演講中提到的,您知道,這對我們來說是一個價值約 10 億美元的潛在市場機會,每年約有 20,000 名符合條件的患者。

  • Jeff Cohen - Analyst

    Jeff Cohen - Analyst

  • Okay. Got it. And then lastly, first, could you talk about cash a little bit? You had a strong Q4 with $10 million of free cash flow. Any thoughts on cash? I know that some portion of that would be for the facility side. Any thoughts there?

    好的。知道了。最後,首先,您能談談現金嗎?第四季表現強勁,自由現金流達 1,000 萬美元。對於現金有什麼想法嗎?我知道其中一部分將用於設施方面。有什麼想法嗎?

  • Joseph Mara - CFO & Treasurer

    Joseph Mara - CFO & Treasurer

  • Yes. So I think we talked about a pretty strong year from kind of a cash flow perspective, but it was great to end the year at a higher place than we started even as we started funding the building. I think as I talked about in the prepared remarks, you know that I mean this is more of the year where you're going to see some more substantial kind of capital and our cash kind of allocated to our new building. But we also expect to continue to generate kind of new cash, additional cash and sort of self fund that so that's probably the key dynamic, I would say, as you think about the cash flow and 2024.

    是的。因此,我認為我們從現金流的角度討論了相當強勁的一年,但即使我們開始為這座大樓提供資金,但以比年初更高的水平結束這一年也是很棒的。我想,正如我在準備好的演講中所說的那樣,你知道我的意思是,在今年的大部分時間裡,你將看到一些更實質的資本和我們的現金分配給我們的新大樓。但我們也預計將繼續產生新的現金、額外的現金和某種自籌資金,所以我想說,當你考慮現金流和 2024 年時,這可能是關鍵動力。

  • Jeff Cohen - Analyst

    Jeff Cohen - Analyst

  • Okay. Perfect. That does it for us. Thanks for the questions.

    好的。完美的。這對我們來說就是這樣。感謝您的提問。

  • Operator

    Operator

  • Swayampakula Ramakanth, HCW.

    斯瓦安帕庫拉·拉瑪坎特 (Swayampakula Ramakanth),HCW。

  • Swayampakula Ramakanth - Analyst

    Swayampakula Ramakanth - Analyst

  • Thank you, and good morning, Mitch, and Joe, most of my questions have been answered, but I just had a quick and question regarding how to think through our NexoBrid arm of not just our 24, but even beyond and just like what we have seen with episode am I remember and even about a year a year and a half ago, you folks I'm not quite sure how to talk through the dynamics of Intercell, but now you have your you, you're able to give guidance for the year. And also I listen to what Joe had talked about special centers and specialty centers and how the product moves through it. So should we expect similar dynamics or since you have had some learnings with how to commercialize Epicel and NexoBrid probably will get to a decent dynamic and earlier than what you had be it instrument datasets.

    謝謝你們,早安,米奇和喬,我的大部分問題都得到了解答,但我只是有一個快速的問題,關於如何思考我們的NexoBrid 手臂,不僅是我們的24 個手臂,甚至超越我們的手臂,就像我們一樣我記得看過這一集,甚至大約一年半前,你們這些人,我不太確定如何談論 Intercell 的動態,但現在你們有了你們,你們能夠提供指導今年。我還聽了喬談論特殊中心和專業中心以及產品如何在其中移動的內容。因此,我們是否應該期待類似的動態,或者既然您已經了解瞭如何將 Epicel 和 NexoBrid 商業化,那麼可能會比您所擁有的儀器資料集更早地獲得不錯的動態。

  • Nick Colangelo - CEO, President & Director

    Nick Colangelo - CEO, President & Director

  • ARKL., I'm trying to parse that out and just you know, the variability that we had seen have seen historically with Epicel is really just a matter of, you know, a smaller patient population that you're typically treating, right? So if you have a few more or less treatments per year when the average treatment is pretty significant in terms of revenue, it can bounce around a little bit. And that's why we've kind of historically said before, again, COVID sort of disruptions that, you know, starting out high single digit or low double digits for Epicel is usually safe ground.

    ARKL.,我正在嘗試解析這個問題,你知道,我們在 Epicel 歷史上看到的變異性實際上只是一個問題,你知道,你通常治療的患者群體較小,對吧?因此,如果您每年有更多或更少的治療,而平均治療在收入方面相當可觀,那麼它可能會出現一點反彈。這就是為什麼我們以前曾說過,新冠疫情會造成某種破壞,你知道,Epicel 的起始高個位數或低兩位數通常是安全的。

  • And we typically outperform that so it's really kind of reverting back to kind of what we did previously with NexoBrid. Of course, you're really sort of playing more at the top of the addressable market funnel where there's, you know, multiple times more patients, 30,000, we believe out of the 40,000 hospitalized patients each year are eligible for NexoBrid treatment.

    我們通常會表現得更好,所以這實際上是回到了我們之前對 NexoBrid 所做的事情。當然,您確實在可尋址市場漏斗的頂部發揮了更多作用,您知道,那裡的患者數倍多,達到 30,000 名,我們相信每年 40,000 名住院患者中有資格接受 NexoBrid 治療。

  • And so yes, once you get through as Joe was talking sort of the initial, you know, dynamics around it and specialty distributor stocking hospital stocking, you had kind of a more mature customer base that has more kind of normalized or routine treatment protocols, then you kind of we would expect, as we've said for a long time that will help dampen any variability that you would see with Epicel as as NexoBrid Canada revenues grow over time. So nothing has changed in terms of our belief on how that will play out and sort of our excitement around NexoBrid.

    所以,是的,一旦你完成了喬所說的最初的動態,你知道,圍繞它的動態和專業經銷商庫存醫院庫存,你就有了一個更成熟的客戶群,有更多類型的標準化或常規治療方案,那麼我們會期望,正如我們長期以來所說的那樣,這將有助於抑制您在 Epicel 中看到的任何變化,因為 NexoBrid 加拿大收入隨著時間的推移而增長。因此,我們對這一切將如何展開的信念以及我們對 NexoBrid 的興奮程度沒有任何改變。

  • Swayampakula Ramakanth - Analyst

    Swayampakula Ramakanth - Analyst

  • Thank you, one one quick question. So do you think you have better and leading indicators with with NexoBrid there? Obviously, it's difficult to say to do that with episode, but is NexoBrid in a better place in that sense?

    謝謝,一一快速提問。那麼您認為 NexoBrid 是否有更好且領先的指標?顯然,很難說用劇集來做到這一點,但從這個意義上說,NexoBrid 是否處於更好的位置?

  • Nick Colangelo - CEO, President & Director

    Nick Colangelo - CEO, President & Director

  • Yeah. Well, again, yes, the answer is definitely yes, because again, as we kind of get into sort of you can kind of think about, you know, we have a certain number of centers, right? 140 burn centers. We've got certain tier targeting of those. As you onboard those, they get PP. and T. committee approvals and then they start to make their initial order. And you see penetration into that. The patients that they see, you'll see sort of teen are more routine reordering patterns. And we're just so early in this right now that, you know, those patterns haven't converge yet. But once they do, we certainly will have sort of more visibility in terms of forecasting as we as we go out.

    是的。嗯,是的,答案肯定是肯定的,因為當我們進入某種程度時,你可以想一想,你知道,我們有一定數量的中心,對嗎?140 個燒傷中心。我們對這些目標有一定的層級定位。當你加入這些時,他們會獲得 PP。和 T. 委員會批准,然後他們開始下初步訂單。你會看到對此的滲透。他們看到的病人,你會看到一些青少年是更常規的重新排序模式。我們現在還處於起步階段,你知道,這些模式還沒有收斂。但一旦他們這樣做了,我們在出去時肯定會在預測方面有更多的可見性。

  • Swayampakula Ramakanth - Analyst

    Swayampakula Ramakanth - Analyst

  • Perfect. Thank you very much. Thanks for taking the questions.

    完美的。非常感謝。感謝您提出問題。

  • Nick Colangelo - CEO, President & Director

    Nick Colangelo - CEO, President & Director

  • All right, thank you.

    好吧。謝謝。

  • Operator

    Operator

  • Thank you. I'm showing no further questions at this time. I'd now like to turn it back to Nick Colangelo for closing remarks.

    謝謝。我目前沒有提出任何進一步的問題。現在我想請尼克·科朗傑洛(Nick Colangelo)做總結發言。

  • Nick Colangelo - CEO, President & Director

    Nick Colangelo - CEO, President & Director

  • Well, thank you, everyone, for your questions and continued interest in Bear. So obviously, we had outstanding financial and business results in 2023. And we expect that the momentum in our core portfolio, new product launches will drive continued strong revenue and profit growth in 2024 in the years ahead. So we look forward to talking to you again at our next call, and thanks and have a great day and thank you for your participation in today's conference.

    好的,謝謝大家的提問以及對熊掌記的持續關注。顯然,我們在 2023 年取得了出色的財務和業務成果。我們預計,我們的核心產品組合和新產品推出的勢頭將在未來幾年推動 2024 年收入和利潤持續強勁增長。因此,我們期待在下次電話會議中再次與您交談,感謝您參加今天的會議,祝您有美好的一天。

  • Operator

    Operator

  • This concludes the program. You may now disconnect.

    程式到此結束。您現在可以斷開連線。