Cryoport Inc (CYRX) 2023 Q3 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

  • Good afternoon, and welcome to Cryoport Third Quarter 2023 Earnings Conference Call. (Operator Instructions). As a reminder, this call is being recorded.

    下午好,歡迎參加 Cryoport 2023 年第三季財報電話會議。 (操作員說明)。提醒一下,此通話正在錄音。

  • I will now turn the call over to your host, Todd Fromer, from KCSA Strategic Communications. Please go ahead.

    我現在將把電話轉給主持人、KCSA 策略傳播部的 Todd Fromer。請繼續。

  • Todd Fromer - Managing Partner & Principal

    Todd Fromer - Managing Partner & Principal

  • Thank you, operator. Before we begin today, I would like to remind everyone that this conference call contains certain forward-looking statements. All statements that address our operating performance, events or developments that we expect or anticipate occurring in the future are forward-looking statements.

    謝謝你,接線生。在今天開始之前,我想提醒大家,本次電話會議包含某些前瞻性陳述。所有涉及我們預期或預期未來發生的經營績效、事件或發展的聲明均為前瞻性聲明。

  • These forward-looking statements are based on management's beliefs and assumptions and not on the information currently available to our management team. Our management team believes that these forward-looking statements are reasonable as and when made. However, you should not place undue reliance on any such forward-looking statements because such statements speak only as of the date when made. We do not undertake any obligation to publicly update or revise any forward-looking statements, whether as a result of new information or future events or otherwise, except as required by law.

    這些前瞻性陳述是基於管理層的信念和假設,而不是基於我們管理團隊目前可獲得的資訊。我們的管理團隊相信這些前瞻性陳述在做出時是合理的。但是,您不應過度依賴任何此類前瞻性聲明,因為此類聲明僅代表發布之日的情況。我們不承擔任何公開更新或修改任何前瞻性聲明的義務,無論是由於新資訊或未來事件或其他原因,除非法律要求。

  • In addition, forward-looking statements are subject to certain risks and uncertainties that could cause actual results, events and developments to differ materially from our historical experience and our present expectations or projections. These risks and uncertainties include, but are not limited to, those described in Item 1A, Risk Factors, and elsewhere in our annual report on Form 10-K filed with the Securities and Exchange Commission, and those described from time-to-time in the other reports, which we file with the Securities and Exchange Commission.

    此外,前瞻性陳述也受到某些風險和不確定性的影響,這些風險和不確定性可能導致實際結果、事件和發展與我們的歷史經驗和目前的預期或預測有重大差異。這些風險和不確定性包括但不限於第 1A 項「風險因素」以及我們向美國證券交易委員會提交的 10-K 表格年度報告中其他部分所述的風險和不確定性,以及不時在我們向美國證券交易委員會提交的其他報告。

  • It is now my pleasure to turn the call over to Mr. Jerrell Shelton, Chief Executive Officer of Cryoport, Jerry, the floor is yours.

    現在我很高興將電話轉給 Cryoport 執行長 Jerell Shelton 先生,Jerry,請發言。

  • Jerrell W. Shelton - Chairman, President & CEO

    Jerrell W. Shelton - Chairman, President & CEO

  • Thank you, Todd. Good afternoon, ladies and gentlemen. We appreciate you joining our earnings call today.

    謝謝你,托德。女士們、先生們,午安。我們感謝您今天參加我們的財報電話會議。

  • With us this afternoon is our Chief Financial Officer, Robert Stefanovich; our Chief Scientific Officer, Dr. Mark Sawicki; and our Vice President of Corporate Development and Investor Relations, Thomas Heinzen.

    今天下午與我們在一起的是我們的財務長 Robert Stefanovich;我們的首席科學官 Mark Sawicki 博士;以及我們的企業發展和投資者關係副總裁 Thomas Heinzen。

  • As a reminder, we have uploaded our third quarter 2023 in review document to our website. It can be found under Investor Relations in the Events & Presentations section. This document provides a review of our financial and operational performance and general business outlook. If you have not had a chance to read it, I would encourage you can go to the website and download it. I will provide a brief update on the business, and then we'll move on to answering your questions.

    謹此提醒,我們已將 2023 年第三季的審核文件上傳到我們的網站。您可以在“活動和演示”部分的“投資者關係”下找到該資訊。本文件回顧了我們的財務和營運表現以及整體業務前景。如果您還沒有機會閱讀它,我建議您可以訪問該網站並下載它。我將提供有關業務的簡短更新,然後我們將繼續回答您的問題。

  • Earlier today, we reported third quarter results that were consistent with our expectations as discussed on our last earnings call, taking into account current and well-known global economic and geopolitical challenges. Having said that, we are continuing to see solid and sustained demand from our key life sciences and cell and gene therapy customers despite the current macroeconomic climate.

    今天早些時候,我們報告了第三季業績,考慮到當前眾所周知的全球經濟和地緣政治挑戰,該業績與我們上次財報電話會議上討論的預期一致。話雖如此,儘管當前的宏觀經濟環境不佳,但我們仍然看到我們的主要生命科學以及細胞和基因治療客戶的穩定和持續的需求。

  • What I mean by that is, when you take a close look, you will see that our quarterly results contain some very promising growth points, including a notable increase in commercial and cell and gene therapy revenue. In fact, commercial revenue increased 54% on year-over-year basis and 52% sequentially. At the same time, our bioservices revenue increased 26% year-over-year.

    我的意思是,當你仔細觀察時,你會發現我們的季度業績包含一些非常有希望的成長點,包括商業、細胞和基因療法收入的顯著增長。事實上,商業收入年增 54%,季增 52%。同時,我們的生物服務收入較去年同期成長26%。

  • Regarding cell and gene therapy, Cryoport Systems grew 10%, both on a year-over-year basis and a quarter-over-quarter basis. All this growth was driven by the sustainable demand we saw during the quarter and that we are continuing to see from advanced therapy manufacturers.

    在細胞和基因治療方面,Cryoport Systems 年比和環比增長了 10%。所有這些成長都是由我們在本季看到的可持續需求以及我們繼續從先進療法製造商看到的可持續需求所推動的。

  • We also continued to increase the number of clinical trials supported. During the quarter, we added a net 27 trials year-over-year, this brings our global clinical programs to a record total of 670, with 81 of these trials being in Phase III, a total of 6 Cryoport-supported BLA, MAAs were filed during the quarter. Looking ahead, during the remainder of 2023, we expect up to an additional 5 anticipated application filings and 1 (sic) [2] new therapy approval.

    我們也持續增加支持的臨床試驗數量。本季度,我們年比淨增加 27 項試驗,這使我們的全球臨床項目總數達到創紀錄的 670 項,其中 81 項試驗處於 III 期,總共 6 項 Cryoport 支持的 BLA、MAA 已獲得批准。本季度提交的。展望未來,在 2023 年剩餘時間內,我們預計將有多達 5 項預期申請提交和 1 項(原文如此)[2] 新療法獲得批准。

  • We think our MVE Biological Solutions order intake has begun to stabilize. MVE's results this quarter were in line with our expectations and our current guidance reflects this. During the quarter, MVE and some 70% of -- with some 70% of the world market continues to produce healthy financial metrics. So we remain quite confident about our long-term market outlook and the recovery of our China market as the country, despite its current economic lows, is a hot bed for the life sciences.

    我們認為我們的 MVE Biological Solutions 訂單量已開始穩定。 MVE 本季的業績符合我們的預期,我們目前的指引也反映了這一點。在本季度,MVE 和約 70% 的全球市場繼續產生健康的財務指標。因此,我們對長期市場前景和中國市場的復甦仍然充滿信心,因為儘管目前經濟低迷,但中國仍然是生命科學的溫床。

  • Alongside our operating results during the third quarter and in the recent weeks, we have continued to execute on our corporate strategy to accelerate our long-term growth through our innovation department -- development projects and small strategic -- and smart strategic acquisitions and partnerships.

    除了第三季和最近幾週的經營業績外,我們還繼續執行我們的企業策略,透過我們的創新部門(開發專案和小型策略)以及明智的策略收購和合作夥伴關係來加速我們的長期成長。

  • For example, this includes our collaboration with Cell and Gene Therapy Catapult, the premier cell and gene therapy manufacturing innovation center in Europe, to provide integrated logistics support for its Stevenage Manufacturing Innovation Centre in the United Kingdom. Further, this partnership, from its location on the Catapult site, will provide other opportunities within the Stevenage bioscience cluster. This collaboration establishes our U.K. logistics center which will -- our first U.K. logistics center, which will further support our European expansion.

    例如,這包括我們與歐洲首屈一指的細胞和基因治療製造創新中心 Cell and Gene Therapy Catapult 的合作,為其位於英國的史蒂夫尼奇製造創新中心提供綜合物流支援。此外,這項合作夥伴關係位於 Catapult 站點,將為史蒂夫尼奇生物科學集群提供其他機會。此次合作建立了我們的英國物流中心,這將是我們的第一個英國物流中心,這將進一步支持我們的歐洲擴張。

  • We recently completed the acquisition of Tec4med Lifesciences, a technology spinoff of the Technical University of Darmstadt, located in Darmstadt, Germany. Tec4med provides next-generation pharmaceutical supply chain visibility by integrating advanced condition monitoring, cloud and artificial intelligence solutions. We are excited about integrating Tec4med's cutting-edge technology for comprehensive monitoring in real time across all Cryoport companies. By doing so, we will expand our digital supply chain solutions offerings and be able to provide our life sciences clients with even greater condition monitoring options, logistics management capabilities and customer support.

    我們最近完成了對 Tec4med Lifesciences 的收購,該公司是位於德國達姆施塔特的達姆施塔特工業大學的技術子公司。 Tec4med 透過整合先進的狀態監測、雲端和人工智慧解決方案,提供下一代藥品供應鏈視覺性。我們很高興能夠整合 Tec4med 的尖端技術,在所有 Cryoport 公司中進行即時全面監控。透過這樣做,我們將擴大我們的數位供應鏈解決方案產品,並能夠為我們的生命科學客戶提供更好的狀態監控選項、物流管理能力和客戶支援。

  • With these latest developments and our leading market positions, we have even greater belief that our long-term growth prospects are solid. There is no other organization in the life sciences with the breadth of capabilities Cryoport has in providing robust dependable end-to-end supply chain solutions.

    憑藉這些最新發展和我們領先的市場地位,我們更加相信我們的長期成長前景是穩固的。在生命科學領域,沒有其他組織能夠像 Cryoport 一樣提供強大、可靠的端到端供應鏈解決方案。

  • Today, CRYOPDP is the world's third largest specialty courier serving the life sciences, covering over 220 countries and territories. MVE Biological Solutions is the world's largest manufacturer of vacuum-insulated products and cryogenic systems and is the preferred brand for academic, government and life sciences companies worldwide.

    如今,CRYOPDP 是世界第三大生命科學專業快遞公司,業務覆蓋 220 多個國家和地區。 MVE Biological Solutions 是全球最大的真空絕熱產品和低溫系統製造商,是全球學術、政府和生命科學公司的首選品牌。

  • Cryoport Systems supports approximately 70% of all the cell and gene therapy clinical trial market, and as we continue building our global supply chain solutions, that share continues to grow even in a challenging environment. And CRYOGENE is one of the industry's most trust -- and specializing in the secure storage of biological specimens and supporting MD Anderson, Baylor, Texas Children, Atara, Lonza, [Starr] and many others.

    Cryoport Systems 支援約 70% 的細胞和基因療法臨床試驗市場,隨著我們繼續建立全球供應鏈解決方案,即使在充滿挑戰的環境中,這一份額也會持續成長。 CRYGENE 是業界最值得信賴的公司之一,專門從事生物樣本的安全存儲,並為 MD Anderson、Baylor、Texas Children、Atara、Lonza、[Starr] 等許多其他機構提供支援。

  • Cryoport is poised to capitalize on the continued growth of the life sciences and especially the cell and gene industry, as more therapies make their way towards commercialization over these coming years. Even with today's economic and geopolitical environment, the cell and gene therapy industry is expected to grow at a 10-year compounded annual growth rate of approximately 20%.

    隨著未來幾年更多療法走向商業化,Cryoport 準備充分利用生命科學,尤其是細胞和基因產業的持續成長。即使在當今的經濟和地緣政治環境下,細胞和基因治療產業預計仍將以約 20% 的 10 年複合年增長率成長。

  • This concludes our prepared remarks, and now I'd be happy to take your questions. Operator, please open the lines for questions.

    我們準備好的發言到此結束,現在我很樂意回答你們的問題。接線員,請打開提問線。

  • Operator

    Operator

  • (Operator Instructions) Your first question comes from Paul Knight from KeyBanc.

    (操作員說明)您的第一個問題來自 KeyBanc 的 Paul Knight。

  • Paul Richard Knight - MD & Senior Analyst

    Paul Richard Knight - MD & Senior Analyst

  • Jerry, congratulations on the quarter. The Vertex sickle cell anemia therapy, I think you've mentioned that in the past, what level of involvement will you have there, is my first question. And then the second question is, if you look back on the MVE, which had its period of softness, but it seems to be stabilizing. Was it kind of overstock globally? And then what portion was just tighter CapEx budgets?

    傑瑞,恭喜這個季度。我想您過去曾提到過 Vertex 鐮狀細胞性貧血療法,您將參與到什麼程度,這是我的第一個問題。那麼第二個問題是,如果你回顧MVE,它有過一段疲軟期,但現在似乎正在穩定下來。全球庫存是否過剩?那麼哪一部分是資本支出預算收緊呢?

  • Jerrell W. Shelton - Chairman, President & CEO

    Jerrell W. Shelton - Chairman, President & CEO

  • Paul, if I understood that, I'll take the second question first and then turn the first question to Mark on sickle cell.

    保羅,如果我理解了這一點,我會先回答第二個問題,然後將第一個問題轉給馬克關於鐮狀細胞疾病的問題。

  • MVE is in a solid position. I mean it's hard for us to dissect exactly how much was overstocking and how much -- exactly what happened in the market except for the conservatism and capital expenditures amongst our customer base. And then, of course, we have to pull back in China, which we think will stabilize. So we think we're in a stable position going forward on MVE, as order intake is stabilized.

    MVE 處於穩固地位。我的意思是,除了我們的客戶群中的保守主義和資本支出之外,我們很難準確剖析有多少庫存過剩以及有多少——市場上到底發生了什麼。然後,當然,我們必須撤回中國,我們認為中國將會穩定下來。因此,我們認為隨著訂單量的穩定,我們在 MVE 方面處於穩定的位置。

  • It looks like it's in good order. And hopefully, China has hit its bottom, and we'll be coming back up. There couldn't be much further impact on us. Our China revenue in total this year -- our first quarter revenue is around 4%. So it's not going to be any kind of a significant China effect going forward, from this point forward, and we think it's stable. So does that answer your question, Paul?

    看起來一切都井井有條。希望中國已經觸底,我們會重新站起來。不會對我們造成太大的影響。我們今年第一季的中國總收入約為 4%。因此,從現在開始,中國不會產生任何重大影響,我們認為它是穩定的。那麼這能回答你的問題嗎,保羅?

  • Paul Richard Knight - MD & Senior Analyst

    Paul Richard Knight - MD & Senior Analyst

  • Yes, very useful. I mean -- I mean, I guess the bottom line is, we're getting past it.

    是的,非常有用。我的意思是——我的意思是,我想底線是,我們正在克服它。

  • Robert S. Stefanovich - Senior VP, CFO & Treasurer

    Robert S. Stefanovich - Senior VP, CFO & Treasurer

  • Yes. And maybe -- let me just add real quick to MVE, because I think sometimes people overlook that, in spite of the revenue level right now in Q2 and Q3, if you look at our product revenue for Q3, the product revenue gross margin is at 45%. And the MVE business has been very profitable, driving good positive adjusted EBITDA and cash flow.

    是的。也許 - 讓我快速補充一下 MVE,因為我認為有時人們會忽略這一點,儘管目前第二季和第三季的收入水平,但如果你看看我們第三季的產品收入,產品收入毛利率是為45%。 MVE 業務利潤豐厚,帶動了良好的調整後 EBITDA 和現金流。

  • Jerrell W. Shelton - Chairman, President & CEO

    Jerrell W. Shelton - Chairman, President & CEO

  • And your first question was on sickle cell, Dr. Sawicki will answer that.

    您的第一個問題是關於鐮狀細胞疾病,Sawicki 博士將回答這個問題。

  • Mark W. Sawicki - Senior VP & Chief Scientific Officer

    Mark W. Sawicki - Senior VP & Chief Scientific Officer

  • Yes, Paul. So we actually had 6 BLA filings, the portfolio companies that were completed in the quarter, which includes [Atara,] ImmunityBio, (inaudible) the CRISPR Vertex program, as well as the label expansion for (inaudible), all of which are playing a role in -- obviously, if they're approved in the commercial launch activity of it. We can't disclose exactly what we're doing due to confidentiality, but we will play a role in all of those products, assuming that they come to fruition.

    是的,保羅。因此,我們實際上有6 個BLA 備案,即本季度完成的投資組合公司,其中包括[Atara、] ImmunityBio、(聽不清楚)CRISPR Vertex 計劃,以及(聽不清楚)的標籤擴展,所有這些都在發揮作用顯然,如果他們在其商業發布活動中獲得批准,他們就會發揮作用。由於保密原因,我們無法準確透露我們正在做什麼,但我們將在所有這些產品中發揮作用,並假設它們能夠實現。

  • So the story is even broader than just the Vertex -- CRISPR Vertex product because we're seeing an acceleration in the commercial filing and activity space, which we think is going to continue to drive that, that strong performance we had in our commercial revenue for the quarter.

    因此,這個故事比 Vertex 更廣泛——CRISPR Vertex 產品,因為我們看到商業申請和活動領域的加速發展,我們認為這將繼續推動我們在商業收入方面的強勁表現對於本季度。

  • Paul Richard Knight - MD & Senior Analyst

    Paul Richard Knight - MD & Senior Analyst

  • And is that filing data in the prior press releases, Mark?

    馬克,這是之前新聞稿中的歸檔資料嗎?

  • Mark W. Sawicki - Senior VP & Chief Scientific Officer

    Mark W. Sawicki - Senior VP & Chief Scientific Officer

  • In prior press releases as it relates to?

    在先前的新聞稿中,它涉及什麼?

  • Thomas J. Heinzen - VP of Corporate Development

    Thomas J. Heinzen - VP of Corporate Development

  • Oh, no, the answer. We haven't disclosed it until this report. It's on -- in the review that we posted on our website.

    哦,不,答案是。直到這份報告我們才揭露。它位於我們在網站上發布的評論中。

  • Paul Richard Knight - MD & Senior Analyst

    Paul Richard Knight - MD & Senior Analyst

  • (inaudible) sorry for saying so -- questioning so much front end, but -- so we might -- we have 6 BLAs in Q3, 5 in Q4. What do you think will end up within a range of this year versus last?

    (聽不清楚)很抱歉這麼說——對前端提出瞭如此多的質疑,但是——所以我們可能——我們在第三季度有 6 個 BLA,在第四季度有 5 個 BLA。您認為今年與去年相比最終會出現什麼情況?

  • Mark W. Sawicki - Senior VP & Chief Scientific Officer

    Mark W. Sawicki - Senior VP & Chief Scientific Officer

  • Well, Tom has that data handy, he tracks it really detailed. Tom, do you got that -- those stats in front of you?

    嗯,湯姆手上有這些數據,他追蹤得非常詳細。湯姆,你明白嗎──你面前的那些統計數據?

  • Thomas J. Heinzen - VP of Corporate Development

    Thomas J. Heinzen - VP of Corporate Development

  • Let me make sure I understand your question. Are you asking how many filings for the year or how many potential approvals for the year?

    讓我確保我理解你的問題。您是在問今年有多少申請書或今年有多少潛在批准嗎?

  • Paul Richard Knight - MD & Senior Analyst

    Paul Richard Knight - MD & Senior Analyst

  • I think filings is a common terminology, you used, Tom, right? So the 11 we will have here in Q3 and Q4. And then the question really is the number of BLAs and MAAs total this year versus last?

    我認為歸檔是一個常見的術語,你用過,湯姆,對吧?所以我們將在第三季和第四季擁有 11 個。那麼問題實際上是今年 BLA 和 MAA 的總數與去年相比?

  • Thomas J. Heinzen - VP of Corporate Development

    Thomas J. Heinzen - VP of Corporate Development

  • It is higher, although it is to be candid lower than what we were forecasting at midyear. A few filings have slipped out into 2024 where we expect 20 filings now that we have visibility on in 2024. So there were about 4 or 5, if I remember correctly, that slipped from 2023 into 2024. The good news is on the approval side for those in 2024, we do have 4 already that have PDUFA dates or FDA dates for decisions in early 2024.

    儘管坦白說,它比我們年中的預測要低,但它還是更高。一些申請已推遲到 2024 年,我們預計 2024 年將有 20 份申請。因此,如果我沒記錯的話,大約有 4 或 5 個申請從 2023 年推遲到 2024 年。好消息是審批方面對於2024 年的項目,我們確實已經有4 個項目的PDUFA 日期或FDA 日期在2024 年初做出決定。

  • Operator

    Operator

  • Your next question comes from David Saxon from Needham.

    你的下一個問題來自尼達姆的大衛·撒克遜。

  • David Joshua Saxon - Senior Analyst

    David Joshua Saxon - Senior Analyst

  • Great. Congrats on the quarter. I did want to just ask a follow-up on the MVE order comments. So what exactly are you seeing stabilize? Like are the orders looking to be flat more sequentially? Are you seeing things have improved to be flat on a year-over-year basis? And then is this worldwide, including China or specific to certain regions?

    偉大的。恭喜本季。我確實想問 MVE 訂單評論的後續情況。那你到底看到什麼穩定了呢?訂單看起來更連續持平?您是否發現情況有所改善,與去年同期相比持平?那麼這是包括中國在內的全球範圍還是特定地區的情況?

  • Jerrell W. Shelton - Chairman, President & CEO

    Jerrell W. Shelton - Chairman, President & CEO

  • David, the -- thanks for the question. I mean we monitor a lot of metrics at MVE. And what I was referring to is the order intake is stable out. It's flattened out and we think that it will continue to be stabilized.

    大衛,謝謝你的提問。我的意思是我們在 MVE 監控很多指標。我指的是訂單量穩定。它已經趨於平緩,我們認為它將繼續保持穩定。

  • David Joshua Saxon - Senior Analyst

    David Joshua Saxon - Senior Analyst

  • Okay. All right. So I guess, stable, flattened out from the second quarter into the third, into the fourth. And then I'll just ask my -- okay. Okay. That's perfect.

    好的。好的。所以我想,穩定,從第二節到第三節,到第四節趨於平緩。然後我會問我的——好吧。好的。那很完美。

  • And then you obviously noted strength in commercial revenue. That was up fairly significantly in Bioservices solutions. And you said in the document you posted that it's continued into the fourth quarter. So can you characterize what you're seeing? Are trends accelerating into the year-end? Are they just kind of stable but continuing to be strong? And then are there any reasons why that wouldn't continue into at least the first half of next year?

    然後你顯然注意到了商業收入的強勁。生物服務解決方案的比例相當顯著。您在發布的文件中表示,這種情況將持續到第四季。那麼你能描述一下你所看到的東西嗎?到年底趨勢是否會加速?他們只是穩定但繼續保持強勢嗎?那麼,有什麼原因導致這種情況至少不會持續到明年上半年?

  • Jerrell W. Shelton - Chairman, President & CEO

    Jerrell W. Shelton - Chairman, President & CEO

  • Go ahead.

    前進。

  • Mark W. Sawicki - Senior VP & Chief Scientific Officer

    Mark W. Sawicki - Senior VP & Chief Scientific Officer

  • Yes. So I'll comment on that. On the Bioservices side, things are very, very consistent and strong. We obviously opened the 2 new facilities in Houston and New Jersey last year. We've actually onboarded 29 new clients into those facilities over the last 18 months, which is a very, very strong base. This is in addition to a very, very strong demand for the -- from the CRYOGENE asset as well. So that's very, very positive.

    是的。所以我會對此發表評論。在生物服務方面,事情非常非常一致和強大。顯然,我們去年在休士頓和新澤西開設了兩個新工廠。實際上,在過去 18 個月裡,我們已經在這些設施中吸引了 29 名新客戶,這是一個非常非常強大的基礎。除此之外,對 CRYGENE 資產的需求也非常非常強勁。所以這是非常非常積極的。

  • On the commercial side, as Tom had mentioned, filing activity is very strong. We see line of sight on a significant increase in the number of approvals and multiple of these products should be fairly decent volume, which will continue to contribute to, obviously, our contribution from a commercial revenue standpoint into '24.

    在商業方面,正如湯姆所提到的,申請活動非常強勁。我們預計批准數量將顯著增加,而且這些產品的數量應該相當可觀,顯然,從商業收入的角度來看,這將繼續為我們對 24 年的貢獻做出貢獻。

  • Robert S. Stefanovich - Senior VP, CFO & Treasurer

    Robert S. Stefanovich - Senior VP, CFO & Treasurer

  • Yes. Maybe just to add, if you look at the Q3 performance in commercial revenue, we'll always have some timing where you have a little bit more revenue in one quarter than the other. But we do expect to see growth overall ongoing in commercial revenue. With that in mind that you'll have some quarters that are higher just because of maybe a greater portion of product-related sales versus service-related sales.

    是的。也許只是補充一下,如果你看看第三季的商業收入表現,我們總是會有一些時間,一個季度的收入比另一個季度多一點。但我們確實預期商業收入將持續成長。考慮到這一點,您可能會發現某些季度的業績會更高,因為產品相關的銷售額可能比服務相關的銷售額所佔的比例更大。

  • Operator

    Operator

  • Your next question comes from John Sourbeer from UBS.

    您的下一個問題來自瑞銀集團 (UBS) 的約翰·索爾比爾 (John Sourbeer)。

  • John Newton Sourbeer - Equity Research Associate

    John Newton Sourbeer - Equity Research Associate

  • Congrats on the quarter. Just maybe to dive in a little bit more on the commercial revenues. Nice growth in the quarter, up 50% year -- over 50% year-over-year. I guess any additional details, I guess, you can provide there on this? Is this additional services you have with some of the previously approved product? Or is there a ramp from some of the newly-approved products here? Just any additional color you could provide on that.

    恭喜本季。也許只是為了投入商業收入。本季成長良好,年增 50%,年成長超過 50%。我想您可以提供任何其他詳細資訊嗎?這是您之前批准的某些產品的附加服務嗎?或者這裡新批准的一些產品是否有成長?您可以提供任何其他顏色。

  • Mark W. Sawicki - Senior VP & Chief Scientific Officer

    Mark W. Sawicki - Senior VP & Chief Scientific Officer

  • The bottom line is we saw contributions (inaudible) you're seeing additional uptake in revenue acceleration out of our portfolio of existing products and, obviously, our support of the Sarepta product has also been a nice contributor to that number for the quarter.

    最重要的是,我們看到了貢獻(聽不清楚),您看到我們現有產品組合的收入加速增長,顯然,我們對Sarepta 產品的支持也對該季度的這一數字做出了很好的貢獻。

  • John Newton Sourbeer - Equity Research Associate

    John Newton Sourbeer - Equity Research Associate

  • And then I guess, just any color on CRYOPDP in the quarter and how the rollout is going there in the U.S.?

    然後我想,本季 CRYOPDP 的任何顏色以及在美國的推廣情況如何?

  • Jerrell W. Shelton - Chairman, President & CEO

    Jerrell W. Shelton - Chairman, President & CEO

  • The CRYOPDP is doing well. The rollout is, we had to make some adjustments in the U.S., and we've made those adjustments, moving forward see that rollout being a continuous smooth rollout.

    CRYOPDP 進展順利。推出是,我們必須在美國做出一些調整,我們已經做出了這些調整,展望未來,推出將是一個持續平穩的推出。

  • John Newton Sourbeer - Equity Research Associate

    John Newton Sourbeer - Equity Research Associate

  • And I guess last one here on my end. Just any additional color you provide on like demand trends across large pharma, maybe emerging biotech. I know the total clinical trials are up year-over-year, but have you noticed any changes in customer behavior then given some of the funding environment or just broader macro pressures?

    我猜最後一個是我這邊。只是您根據大型製藥公司(也許是新興生物技術公司)的類似需求趨勢提供的任何其他顏色。我知道臨床試驗總數逐年增加,但考慮到一些融資環境或更廣泛的宏觀壓力,您是否注意到客戶行為有任何變化?

  • Jerrell W. Shelton - Chairman, President & CEO

    Jerrell W. Shelton - Chairman, President & CEO

  • As I said during our last quarter's call, I think that the development of this industry is similar to biologics. And if you look at biologics in a way, it has (inaudible) in the beginning and then leveled out and everyone today would want to be in biologics, it's in the pharmaceutical business. It's a fantastic business and a larger business. And we're on the same track. We're in the beginning phases of the development of this industry. We're developing solutions to answer questions in this industry, to answer needs in this industry and to help it propel and move forward. And we think we're on the same track as biologics, if not better than that track.

    正如我在上個季度的電話會議中所說,我認為這個行業的發展與生物製劑類似。如果你以某種方式看待生物製劑,它在一開始(聽不清楚),然後趨於平穩,今天每個人都想進入生物製劑,它是在製藥行業。這是一個很棒的生意,而且是一個更大的生意。我們在同一條軌道上。我們正處於這個產業發展的起步階段。我們正在開發解決方案來回答這個行業的問題、滿足這個行業的需求並幫助它推動和向前發展。我們認為我們與生物製劑處於同一軌道上,即使不比那條軌道更好。

  • Operator

    Operator

  • Your next question comes from Jacob Johnson from Stephens.

    您的下一個問題來自斯蒂芬斯的雅各布·約翰遜。

  • Jacob K. Johnson - MD & Analyst

    Jacob K. Johnson - MD & Analyst

  • Congrats on the quarter. Maybe not to belabor the point, but just one more follow-up on the commercial revenue. Really strong growth. Dr. Sawicki, if I heard you correctly, it sounds like Sarepta was some portion of that. At the risk of asking a question you may not want to answer, but any way to tease out how much Sarepta was a contribution of growth this quarter?

    恭喜本季。也許不是為了強調這一點,而是對商業收入的另一個後續行動。成長確實強勁。 Sawicki 博士,如果我沒聽錯的話,聽起來 Sarepta 就是其中的一部分。冒著提出問題的風險,您可能不想回答,但有什麼方法可以弄清楚 Sarepta 對本季成長的貢獻有多大?

  • Mark W. Sawicki - Senior VP & Chief Scientific Officer

    Mark W. Sawicki - Senior VP & Chief Scientific Officer

  • Yes. We don't break it out on a client-specific basis, but it was a meaningful contribution. I'll leave it at that.

    是的。我們不會針對特定客戶進行分解,但這是一個有意義的貢獻。我就這樣吧。

  • Jacob K. Johnson - MD & Analyst

    Jacob K. Johnson - MD & Analyst

  • Okay. That's helpful. And then maybe a bigger picture question just on IntegriCell. I think that's a platform you guys have continued to build out over the last year. I'm just kind of curious where that stands on a revenue basis and as we head into next year, what's the opportunity around that offering?

    好的。這很有幫助。然後也許是關於 IntegriCell 的更大的問題。我認為這是你們在過去一年中不斷建立的平台。我只是有點好奇這在收入基礎上的情況如何,當我們進入明年時,圍繞該產品的機會是什麼?

  • Jerrell W. Shelton - Chairman, President & CEO

    Jerrell W. Shelton - Chairman, President & CEO

  • I'm going to start and let Dr. Sawicki, then take over. But the IntegriCell was started during the last year, and it's progressing. But these are -- this is a novel solution for the cell and gene therapy industry, it's something that's needed in the industry. It will have to be not only the plants built out and finished, and Mark can comment on that. But then they will have to be validated and customers will then do their audits. But we have -- we already are seeing demand coming in. This is a customer-driven endeavor. So we know it's going to be successful. Mark?

    我將開始並讓 Sawicki 博士接手。但 IntegriCell 是在去年啟動的,並且正在取得進展。但這些是——這是細胞和基因治療行業的一種新穎的解決方案,是該行業所需要的。不僅僅是工廠的建成和完工,馬克可以對此發表評論。但隨後它們必須經過驗證,然後客戶將進行審核。但我們已經看到了需求的到來。這是一項以客戶為導向的努力。所以我們知道它會成功。標記?

  • Mark W. Sawicki - Senior VP & Chief Scientific Officer

    Mark W. Sawicki - Senior VP & Chief Scientific Officer

  • Yes, just to add on that. So the site in Houston is construction complete, we're just going through all the validation activities as we speak. If the site in Belgium is nearly construction complete, we will be running a couple of months behind the site in Houston.

    是的,只是補充一下。休士頓的站點已經施工完成,我們正在進行所有驗證活動。如果比利時的站點即將完工,我們的運行將比休士頓的站點晚幾個月。

  • As Jerry mentioned, we're already seeing very strong interest. We've already had a significant number of clients come through the facility even during construction. And we also have a -- already have a robust pipeline as it relates to folks that are evaluating it to be able to step into their clinical and commercial opportunities. So when the facilities come online in '24, we believe that will be a very, very nice and quick uptake with that asset as it comes online.

    正如傑瑞提到的,我們已經看到了非常強烈的興趣。即使在施工期間,我們已經有大量客戶來到該設施。我們還擁有一個強大的管道,因為它與正在評估它的人相關,以便能夠進入他們的臨床和商業機會。因此,當這些設施在 24 年上線時,我們相信,隨著該資產上線,這將是一個非常非常好的和快速的吸收。

  • Operator

    Operator

  • Your next question comes from Tejas Savant from Morgan Stanley.

    您的下一個問題來自摩根士丹利的 Tejas Savant。

  • Yuko Oku - Research Associate

    Yuko Oku - Research Associate

  • This is Yuko on for Tejas. You talked about MVE demand starting to stabilize in China. Are you seeing effects of anticorruption initiatives still continuing in the region? And what do you think needs...

    這是代表光輝號的 Yuko。您談到中國的 MVE 需求開始穩定。您是否認為反貪腐措施的影響仍在該地區持續?還有你認為需要什麼...

  • Jerrell W. Shelton - Chairman, President & CEO

    Jerrell W. Shelton - Chairman, President & CEO

  • I'm sorry, you're coming through on the phone very weak. I didn't really get your question in China.

    抱歉,你打電話時聲音很弱。我在中國沒聽懂你的問題。

  • Yuko Oku - Research Associate

    Yuko Oku - Research Associate

  • Sorry about that, is that a little bit better?

    抱歉,這樣會好一點嗎?

  • Jerrell W. Shelton - Chairman, President & CEO

    Jerrell W. Shelton - Chairman, President & CEO

  • Yes, that's better, that's better. Thank you.

    是的,這樣更好,這樣更好。謝謝。

  • Yuko Oku - Research Associate

    Yuko Oku - Research Associate

  • You talked about MVE demand starting to stabilize in China. Are you seeing effects of anticorruption initiatives still continuing in the region? And what do you think needs to ultimately happen to begin seeing recovery of that market?

    您談到中國的 MVE 需求開始穩定。您是否認為反貪腐措施的影響仍在該地區持續?您認為最終需要發生什麼才能開始看到該市場的復甦?

  • Jerrell W. Shelton - Chairman, President & CEO

    Jerrell W. Shelton - Chairman, President & CEO

  • We're not experts on the internal workings of China and what's on the administration's mind. But what we can tell you is that there has been some reserve as a result of the Foreign Corrupt Practices Act and so people are lying low. They don't want to get caught in investigations and that sort of thing. So it is suppressing the market. And hopefully, that will open up very shortly. And President Xi is taking initiatives within the economy to stimulate it. But it's not -- it's hard to predict exactly when that -- when those initiatives will have some impact. We know one thing. We can't discount China because it is a hot bed of activity for the life sciences and we intend to participate there.

    我們不是中國內部運作和政府想法的專家。但我們可以告訴你的是,由於《反海外腐敗法》的實施,人們有了一些保留,因此人們都保持低調。他們不想陷入調查之類的事情。所以它正在壓制市場。希望很快就會開放。習主席正在經濟領域採取措施來刺激經濟。但很難準確預測這些措施何時會產生一些影響。我們知道一件事。我們不能低估中國,因為它是生命科學活動的溫床,我們打算參與其中。

  • Yuko Oku - Research Associate

    Yuko Oku - Research Associate

  • Great. Thank you for that color. And then a separate follow-up. Could you elaborate more on the Tec4med Lifescience acquisition? How does their condition monitoring with AI differ from capabilities offered by Cryoport? And how do you envision incorporating their condition monitoring capabilities into Cryoportal and Smartpak II condition monitoring system?

    偉大的。謝謝你的那個顏色。然後是單獨的後續行動。能否詳細介紹一下 Tec4med Lifescience 的收購?他們的 AI 狀態監測與 Cryoport 提供的功能有何不同?您如何設想將他們的狀態監控功能整合到 Cryoportal 和 Smartpak II 狀態監控系統中?

  • Jerrell W. Shelton - Chairman, President & CEO

    Jerrell W. Shelton - Chairman, President & CEO

  • I'll start, and then I'm going to turn it over to Mark for further comment. But Tec4med is truly a tactical acquisition with true strategic impact. The technologies that's been developed by Tec4med over the last 8 years of its existence is, is fantastic technology. It's complementary to much of the technology that we have within Cryoport or have underway at Cryoport, and it is -- it will boost it. It will actually boost it. It will have synergistic value. It has a number of features that are going to have significant impact, certainly on Cryoport, and we think on the market in the future.

    我先開始,然後將其交給馬克以供進一步評論。但 Tec4med 確實是具有真正戰略影響力的戰術收購。 Tec4med 在其存在的過去 8 年中開發的技術是非常棒的技術。它與我們在 Cryoport 內擁有的或在 Cryoport 正在進行的大部分技術是互補的,而且它確實會推動它的發展。它實際上會增強它。它將具有協同價值。它具有許多將產生重大影響的功能,尤其是對 Cryoport 以及我們對未來市場的看法。

  • So with that, I'll turn it over to Mark to make further comments.

    因此,我將把它交給馬克來發表進一步的評論。

  • Mark W. Sawicki - Senior VP & Chief Scientific Officer

    Mark W. Sawicki - Senior VP & Chief Scientific Officer

  • Yes. Thanks, Jerry. Jerry is exactly right. It's a very complementary product to our existing Smartpak II condition monitoring platform. It will provide us more depth with different service levels and competencies from obviously high-end real-time monitoring, as well as all the way down to a disposable data loggers for 1-way or unidirectional transit packaging. So it's a very complementary product for us, the product suite itself will dovetail very nicely into what we've built within our existing portfolio of services.

    是的。謝謝,傑瑞。傑瑞是完全正確的。它是我們現有 Smartpak II 狀態監控平台的一個非常互補的產品。它將為我們提供更深入的不同服務等級和能力,從明顯高端的即時監控,一直到用於單向或單向運輸包裝的一次性數據記錄器。因此,它對我們來說是一個非常互補的產品,產品套件本身將與我們在現有服務組合中建立的產品非常吻合。

  • Jerrell W. Shelton - Chairman, President & CEO

    Jerrell W. Shelton - Chairman, President & CEO

  • I'd just add just a couple of things. Just a couple of things on that. Look, you asked about AI. We've been using AI for a number of years. AI is an important technology. It's advancing very quickly. They have that capability.

    我只想添加幾件事。關於這一點只有幾件事。聽著,你問的是人工智慧。我們使用人工智慧已經很多年了。人工智慧是一項重要技術。進展非常快。他們有這個能力。

  • And the other thing is, Tec4med is very communications friendly. It's enhanced beyond anything on the market today, and we'll be taking advantage of that. You'll see it.

    另一件事是,Tec4med 非常適合溝通。它的增強程度超過了當今市場上的任何產品,我們將充分利用這一點。你會看到的。

  • Operator

    Operator

  • Your next question comes from Yuan Zhi from B. Riley.

    您的下一個問題來自 B. Riley 的袁志。

  • Yuan Zhi - Research Analyst of Healthcare

    Yuan Zhi - Research Analyst of Healthcare

  • Great to see the strong revenue from commercial cell and gene therapies. So we heard some of the cell and gene therapy manufacturers ignored weakness in 4Q. How do you see this trend so far in this quarter and the next couple of months? And then I have a follow-up question.

    很高興看到商業細胞和基因療法的強勁收入。因此,我們聽說一些細胞和基因治療製造商忽略了第四季的疲軟。您如何看待本季到目前為止以及未來幾個月的這一趨勢?然後我有一個後續問題。

  • Mark W. Sawicki - Senior VP & Chief Scientific Officer

    Mark W. Sawicki - Senior VP & Chief Scientific Officer

  • I'm sorry, you've seen some of the commercial -- CDMOs doing what?

    抱歉,您看過一些商業 CDMO 在做什麼?

  • Thomas J. Heinzen - VP of Corporate Development

    Thomas J. Heinzen - VP of Corporate Development

  • Yes. I'll take it, Mark. You're right, there were mixed quarters from the commercial -- our commercial customers. Some of them had revenue below Street expectations. Others exceeded it by a lot, namely J&J, Legend and Sarepta. It is going to be a mixed bag in Q4 based on what they're telling the Street. So we can't really comment more on their forecast.

    是的。我會接受的,馬克。你是對的,商業領域——我們的商業客戶——有混合的群體。其中一些公司的收入低於華爾街的預期。其他公司則遠遠超過了它,包括強生(J&J)、傳奇(Legend)和薩雷普塔(Sarepta)。根據他們向華爾街透露的情況,第四季的情況將是一個好壞參半的情況。因此,我們無法對他們的預測做出更多評論。

  • Yuan Zhi - Research Analyst of Healthcare

    Yuan Zhi - Research Analyst of Healthcare

  • Got it. And now follow-up question is related to the Tec4med acquisition. Does it mean now Cryoport would expand the capability to provide logistics to pharmaceuticals outside of the cell and gene therapy?

    知道了。現在的後續問題與 Tec4med 收購有關。這是否意味著現在 Cryoport 將擴大為細胞和基因治療以外的藥品提供物流的能力?

  • Mark W. Sawicki - Senior VP & Chief Scientific Officer

    Mark W. Sawicki - Senior VP & Chief Scientific Officer

  • The short answer is yes, it's complementary to our CRYOPDP logistics offering, and it will provide them additional and enhanced competencies as it relates to data monitoring for areas outside of the cell and gene space.

    簡而言之,答案是肯定的,它是我們 CRYOPDP 物流產品的補充,並將為他們提供額外和增強的能力,因為它涉及細胞和基因空間之外區域的數據監控。

  • Operator

    Operator

  • Your next question comes from David Larsen from BTIG.

    您的下一個問題來自 BTIG 的 David Larsen。

  • David Michael Larsen - MD and Senior Healthcare IT & Digital Health Analyst

    David Michael Larsen - MD and Senior Healthcare IT & Digital Health Analyst

  • Can you talk about large freezer shipments within MVE? How is that progressing? Has growth picked back up? Or is it steady, stable?

    您能談談 MVE 內的大型冷凍櫃運輸嗎?進展如何?成長已回升嗎?還是穩定、穩定?

  • Jerrell W. Shelton - Chairman, President & CEO

    Jerrell W. Shelton - Chairman, President & CEO

  • Yes, David, the orders for freezers are back on trend. And I said on a stabilized basis is on -- and there was a clarifying question asked earlier about second, third -- second, maybe on first and second quarter. And so orders have stabilized across the board, the patterns are stable.

    是的,大衛,冰櫃的訂單又恢復了趨勢。我說過,在穩定的基礎上,早些時候有人提出了一個關於第二、第三、第二,也許是第一和第二季的澄清問題。所以訂單全面穩定,格局穩定。

  • David Michael Larsen - MD and Senior Healthcare IT & Digital Health Analyst

    David Michael Larsen - MD and Senior Healthcare IT & Digital Health Analyst

  • Okay. And then how many therapies -- cell and gene therapy products, would you expect to get approved each year, roughly speaking. I think you were supporting around 15, last quarter. And I mean your commercial revenue, it's pushing 10% of total revenue, I think. I'm just trying to get a sense for how much of your total revenue you think that could become, like into next year, and the following years, it seems like it's growing pretty rapidly.

    好的。粗略地說,您預計每年有多少種療法(細胞和基因療法產品)獲得批准。我認為上個季度您支持了大約 15 個。我的意思是你的商業收入,我認為它佔總收入的 10%。我只是想了解您認為這可能會佔您總收入的多少,就像明年和接下來的幾年一樣,它似乎增長得相當快。

  • Jerrell W. Shelton - Chairman, President & CEO

    Jerrell W. Shelton - Chairman, President & CEO

  • All right. I'll start to answer the question, David. But then Mark and Tom should add their comments as well. Look, the whole -- this is no surprise. I mean, commercial therapy is what it's all about. And we support them in those trials because in order to get to the commercial -- to get these therapies to the commercial arena. And as we start to improve -- [approve] 10 therapies per year, it's certainly, the commercial revenue is going to dwarf depending on the number of patient potential for the indication, but it's going to dwarf the revenue from clinical trials, and that's coming.

    好的。我將開始回答這個問題,大衛。但馬克和湯姆也應該添加他們的評論。看,整體而言——這並不奇怪。我的意思是,商業療法就是一切。我們在這些試驗中支持他們,因為為了商業化——將這些療法推向商業舞台。當我們開始改進時——每年[批准]10種療法,毫無疑問,商業收入將會相形見絀,具體取決於該適應症的潛在患者數量,但這將使臨床試驗的收入相形見絀,這就是未來。

  • So it's coming. That's what we're building the company for. That's why we're investing in the -- in all of these initiatives for the future because we have to be there ready to support the industry as it commercializes. Mark, do you want to add to that?

    所以它來了。這就是我們建立公司的目的。這就是為什麼我們要投資未來的所有這些舉措,因為我們必須做好準備,在該行業商業化時為其提供支持。馬克,你想補充一下嗎?

  • Mark W. Sawicki - Senior VP & Chief Scientific Officer

    Mark W. Sawicki - Senior VP & Chief Scientific Officer

  • Yes. Yes, the numbers, actually, we're currently supporting 12 commercial products, and Jerry is exactly right. Our entire strategy has been to capture the clinical space and retain it during commercialization. Gottlieb said back in 2019 that he anticipated by 2024 to '25, 20 commercial approvals a year. And we're actually starting to see line of sight on that number. And so we're very excited by that, especially because we're supporting such a large percentage of the clinical space. We wholeheartedly anticipate and expect to retain the vast majority goes through commercial, and we're building out our infrastructure to support that scale.

    是的。是的,實際上,我們目前支援 12 種商業產品,Jerry 說得完全正確。我們的整個策略是佔領臨床空間並在商業化過程中保留它。 Gottlieb 早在 2019 年就曾表示,他預計到 2024 年至 25 年間,每年將獲得 20 個商業批准。我們實際上開始看到這個數字。因此,我們對此感到非常興奮,特別是因為我們支持如此大比例的臨床空間。我們全心全意地期望並希望保留絕大多數透過商業化的方式,並且我們正在建立我們的基礎設施來支持這一規模。

  • David Michael Larsen - MD and Senior Healthcare IT & Digital Health Analyst

    David Michael Larsen - MD and Senior Healthcare IT & Digital Health Analyst

  • Okay, and...

    好吧,還有…

  • Thomas J. Heinzen - VP of Corporate Development

    Thomas J. Heinzen - VP of Corporate Development

  • (inaudible) it's 12 commercial today. Hopefully, 2 more will get approved before the end of the year, that would bring us to 14. Those 2 do have PDUFA dates or FDA dates before the end of the year. And then we have 6 more we're forecasting to commercialize next year. That would bring us to 20 total, if we're right. Of those 6 that we're forecasting for next year, 4 already have PDUFA dates in the first -- a little over the first 4 months of the year. And hopefully, that number will grow above 6, but that's what we're seeing today.

    (聽不清楚)今天是 12 點廣告。希望年底前還有 2 個藥物獲得批准,這樣我們的藥物數量就達到 14 個。這 2 個藥物在年底前確實有 PDUFA 日期或 FDA 日期。我們預計明年還將有 6 個項目實現商業化。如果我們是對的,那麼總數將達到 20 個。在我們預測明年的 6 個國家中,有 4 個國家已經在第一時間確定了 PDUFA 日期——比今年前 4 個月稍長。希望這個數字能夠成長到 6 以上,但這就是我們今天看到的情況。

  • David Michael Larsen - MD and Senior Healthcare IT & Digital Health Analyst

    David Michael Larsen - MD and Senior Healthcare IT & Digital Health Analyst

  • How much revenue do you think those 6 could contribute to the business?

    您認為這 6 個人能為公司帶來多少收入?

  • Mark W. Sawicki - Senior VP & Chief Scientific Officer

    Mark W. Sawicki - Senior VP & Chief Scientific Officer

  • (inaudible) what that anticipated number is. But obviously, we expect the commercial growth number to be disproportionate to our overall growth number over time.

    (聽不清楚)預期數字是多少。但顯然,隨著時間的推移,我們預期商業成長數字將與我們的整體成長數字不成比例。

  • Operator

    Operator

  • Your next question comes from Brandon Couillard from Jefferies.

    您的下一個問題來自 Jefferies 的 Brandon Couillard。

  • Brandon Couillard - Equity Analyst

    Brandon Couillard - Equity Analyst

  • Maybe for Robert. Circling back to the comment that you guys said, you saw the strong cell and gene therapy demand continue here into 4Q. Is it fair to assume that commercial revenues will be up sequentially in 4Q versus 3Q?

    也許是為了羅伯特。回到你們所說的評論,你們看到強勁的細胞和基因治療需求持續到第四季。假設第四季商業收入將比第三季連續成長是否公平?

  • Robert S. Stefanovich - Senior VP, CFO & Treasurer

    Robert S. Stefanovich - Senior VP, CFO & Treasurer

  • No, I think the way you have to look at, is really, obviously, longer term, we expect to see very solid growth on the cell and gene therapy side for commercial revenues as we add more commercial therapies to the portfolio.

    不,我認為你必須看待的方式是,很明顯,從長遠來看,隨著我們在產品組合中添加更多的商業療法,我們預計細胞和基因治療方面的商業收入將出現非常穩健的增長。

  • If you look at quarter and sequential growth, just because of the early stage of this revenue stream, you will have just timing-wise, different revenue streams. So we expect to see growth year-over-year, clearly but sequential growth really depends a little bit on the type of services we provide the type of accessories we provide. So that may vary between quarter-to-quarter sequentially. But ultimately, again, we look at growth year-over-year ongoing.

    如果你看看季度和連續成長,僅僅因為這個收入流的早期階段,你就會有時間上不同的收入流。因此,我們預計會看到同比增長,顯然,但環比增長實際上在一定程度上取決於我們提供的服務類型和我們提供的配件類型。因此,每季的情況可能會有所不同。但最終,我們再次關注同比持續成長。

  • Mark W. Sawicki - Senior VP & Chief Scientific Officer

    Mark W. Sawicki - Senior VP & Chief Scientific Officer

  • Yes, that's why we always say you guys, look at commercial on a rolling basis. We recommend looking at a 4-quarter rolling average, and that's where you should see very consistent growth as we look at that because there is some volatility quarter-to-quarter based on the timing of certain products and services that we're doing from a commercial standpoint.

    是的,這就是為什麼我們總是說你們要滾動觀看廣告。我們建議查看 4 季度滾動平均值,當我們查看時,您應該會看到非常一致的增長,因為根據我們正在進行的某些產品和服務的時間安排,季度與季度之間存在一些波動。商業角度。

  • Brandon Couillard - Equity Analyst

    Brandon Couillard - Equity Analyst

  • Got it. Appreciate it. And then I guess any more color you guys can add on the 27 new trial adds, pretty impressive just given kind of all the headlines around there of funding, is a [healthy clip] for you guys. Is that mostly existing customers building up the portfolio, anything competitive wins? Maybe I haven't talked about this in a while, but maybe folks shifting from (inaudible) on the earlier stage side, do you guys just kind of talk about who is kind of driving those 27 net new adds for you guys?

    知道了。欣賞它。然後我想你們可以在 27 個新的試驗中添加更多的色彩,考慮到周圍所有的資金頭條新聞,這非常令人印象深刻,對你們來說是一個[健康的剪輯]。大多數現有客戶都在建立產品組合,有什麼競爭優勢可以獲勝嗎?也許我已經有一段時間沒有談論這個了,但也許人們已經從(聽不清楚)早期階段轉向了,你們是否只是談論誰在為你們推動這 27 個淨新增內容?

  • Mark W. Sawicki - Senior VP & Chief Scientific Officer

    Mark W. Sawicki - Senior VP & Chief Scientific Officer

  • Yes. So I can do Tom, that's fine. Yes. So of those, we're still seeing above-average volatility on removals, so that -- we're actually seeing net increases that are higher than that. But with the volatility in the space, we're seeing still a fair deal of trials that are either being completed or terminated or suspended on a quarter-by-quarter basis.

    是的。所以我可以做湯姆,那很好。是的。因此,其中,我們仍然看到清除量的波動性高於平均水平,因此,我們實際上看到的淨增長高於該水平。但由於該領域的波動性,我們仍然看到大量試驗正在按季度完成、終止或暫停。

  • And so for Q3, we added 28. We had 26 that wind down of those 15 were completed, 9 were terminated and 2 were suspended. A fairly large percentage of those, and I don't have the number in front of me, are new clients. So we've been very successful in pulling share on the new client basis, as well as retaining in our existing trial base with our existing clients. Tom, I am not sure if you want to add anything else?

    因此,在第三季度,我們增加了 28 個。我們有 26 個項目,其中 15 個項目已完成,9 個項目已終止,2 個項目已暫停。其中很大一部分是新客戶,但我沒有掌握具體數字。因此,我們非常成功地擴大了新客戶的份額,並保留了現有客戶的現有試用基地。湯姆,我不確定你是否還想補充什麼?

  • Thomas J. Heinzen - VP of Corporate Development

    Thomas J. Heinzen - VP of Corporate Development

  • No, you covered it, Mark. Thank you.

    不,你已經涵蓋了,馬克。謝謝。

  • Operator

    Operator

  • Your next question comes from Richard Baldry from ROTH MKM.

    您的下一個問題來自 ROTH MKM 的 Richard Baldry。

  • Richard Kenneth Baldry - MD & Senior Research Analyst

    Richard Kenneth Baldry - MD & Senior Research Analyst

  • You had a spate of new product and service sort of upgrades, enhancements and rollout lately. I felt like a lot of your R&D projects sort of come to fruition, but this quarter, R&D is up about 21% sequentially. Can you talk about sort of where those incremental investments are going? Is this -- was there anything onetime in there? Is this sort of a new sustained or extensible level? How do we think about that?

    最近有大量新產品和服務的升級、增強和推出。我覺得你們的許多研發項目都取得了成果,但本季的研發項目較上季成長了約 21%。您能談談這些增量投資的去向嗎?這是──裡面曾經有過什麼東西嗎?這是一種新的持續或可擴展的水平嗎?我們對此有何看法?

  • Jerrell W. Shelton - Chairman, President & CEO

    Jerrell W. Shelton - Chairman, President & CEO

  • Robert, do you want to take that?

    羅伯特,你想要那個嗎?

  • Robert S. Stefanovich - Senior VP, CFO & Treasurer

    Robert S. Stefanovich - Senior VP, CFO & Treasurer

  • Yes, absolutely. Look, if you look at our R&D expenditures, we have a number of initiatives that are ongoing. Some obviously have come to fruition such as the Cryoport Elite Shipper that's being used for Sarepta and ultimately available to other clients in the cell and gene therapy space.

    是的,一點沒錯。看看我們的研發支出,我們有許多正在進行的舉措。有些顯然已經取得了成果,例如用於 Sarepta 的 Cryoport Elite Shipper,並最終可供細胞和基因治療領域的其他客戶使用。

  • Others are still ongoing. We recently launched the Cryoportal 2. We have some additional activities related to that Cryoportal 2 and logistics management system. We're also working on condition monitoring systems, SkyTrax. So there are some ongoing investments in R&D activities related to those initiatives that we expect to complete during 2024.

    其他仍在進行中。我們最近推出了 Cryoportal 2。我們還有一些與 Cryoportal 2 和物流管理系統相關的其他活動。我們也致力於開發狀態監控系統 SkyTrax。因此,與我們預計在 2024 年完成的這些措施相關的研發活動正在進行一些投資。

  • Jerrell W. Shelton - Chairman, President & CEO

    Jerrell W. Shelton - Chairman, President & CEO

  • In addition, Rich, we have the global supply chain network, which continues to progress nicely, but it certainly is not to its full maturation. And so all in all, it's progressing the way we expected, but it is robust.

    此外,Rich,我們擁有全球供應鏈網絡,該網絡繼續良好發展,但肯定還沒有完全成熟。總而言之,它正在按照我們預期的方式進展,但它很穩健。

  • Mark W. Sawicki - Senior VP & Chief Scientific Officer

    Mark W. Sawicki - Senior VP & Chief Scientific Officer

  • Yes. We're actually seeing a very nice monetization of the services that have launched. I mean you guys have seen that the 2 new facilities, the one in New Jersey and the one down in Houston, Texas, those facilities are now averaging 1.5 audits a week. We put 29 new Bioservices clients in those facilities over the last year. I mean, so it's substantial. And that's monetization of those investments.

    是的。實際上,我們看到已推出的服務實現了非常好的貨幣化。我的意思是,你們已經看到了 2 個新設施,一個位於新澤西州,另一個位於德克薩斯州休斯頓,這些設施現在平均每週進行 1.5 次審核。去年,我們在這些設施中安置了 29 個新的 Bioservices 客戶。我的意思是,所以它很重要。這就是這些投資的貨幣化。

  • Richard Kenneth Baldry - MD & Senior Research Analyst

    Richard Kenneth Baldry - MD & Senior Research Analyst

  • And there's a lot of talk about the private equity and VCs pulling back on their portfolios. Can you maybe talk broadly about the acquisition environment. Are you seeing more opportunities? Do you think valuations are finally coming into better zones for you to go after?

    關於私募股權和創投公司撤回投資組合的討論很多。您能否廣泛地談談收購環境?您是否看到更多機會?您認為估值終於進入了您可以追求的更好區域嗎?

  • Jerrell W. Shelton - Chairman, President & CEO

    Jerrell W. Shelton - Chairman, President & CEO

  • No, Rich. We actually don't look at it that way. We look at things fit in our strategy and fit to where we're going, and we don't see any big change in that area.

    不,里奇。我們其實並不這麼看。我們著眼於適合我們的策略和我們的發展方向的事情,我們沒有看到該領域有任何重大變化。

  • Richard Kenneth Baldry - MD & Senior Research Analyst

    Richard Kenneth Baldry - MD & Senior Research Analyst

  • Right. And lastly, looking at the balance sheet, you took out some of the convertibles early and how to gain on that and did buybacks same time. How do you think about the capital structure as it sits today? Was it just opportunistic on the convert side, do you think that's strategic, you want to keep that up, if at all possible? How -- what level of cash would you be comfortable with aside from doing the buybacks?

    正確的。最後,看看資產負債表,你提前拿出了一些可轉換債券,以及如何從中獲利並同時進行了回購。您如何看待目前的資本結構?這是否只是轉換方的機會主義,您認為這是策略性的,您想保持這種狀態(如果可能的話)嗎?除了回購之外,您對什麼水準的現金感到滿意?

  • Jerrell W. Shelton - Chairman, President & CEO

    Jerrell W. Shelton - Chairman, President & CEO

  • Rich, in today's environment, it's a question that we constantly are asking ourselves, and we're constantly monitoring. But we have the geopolitical situation. We have an industry that's developing very rapidly. We have -- a lot of things are going on. There's a lot of dynamics. We do have acquisition opportunities that come up occasionally. We want to be prepared with -- to move on those when they do come up.

    Rich,在現今的環境中,這是我們不斷問自己、不斷監控的問題。但我們有地緣政治局勢。我們有一個發展非常迅速的行業。我們有很多事情正在發生。有很多動態。我們確實偶爾會出現收購機會。我們希望做好準備——當這些問題確實出現時,我們就繼續採取行動。

  • So managing the cash and managing the buybacks is an artful thing, and it's one that we do look at on a constant basis, but we're measured in that, so we do -- we are open and we're very open to all the information that comes in and we make our decision. So it's not much else I can say about that, except we're constantly looking at it.

    因此,管理現金和管理回購是一件巧妙的事情,我們確實會持續關注這一點,但我們對此進行了衡量,所以我們這樣做——我們是開放的,我們對所有人都非常開放我們根據收到的資訊做出決定。因此,除了我們不斷地關注它之外,我對此無話可說。

  • Robert S. Stefanovich - Senior VP, CFO & Treasurer

    Robert S. Stefanovich - Senior VP, CFO & Treasurer

  • Yes. Maybe I can just add some data points to it. If you look at -- you're absolutely right, we did buy equity in the past, and in this just recent third quarter, we did repurchase some of the convertibles that's some of the 2026 convertible debt. So we have actually a gain of about $6.2 million in the income statement gross gain from that repurchase, really, buying the converts at about $0.80 on the dollar. So we are monitoring that. And with the repurchase program, we still have about $36 million remaining to deploy under that program. And so we have some of the ability to repurchase additional convertible debt or equity if we think the timing is right and it's warranted.

    是的。也許我可以在其中添加一些數據點。如果你看一下——你是絕對正確的,我們過去確實購買了股權,在最近的第三季度,我們確實回購了一些可轉換債券,這些可轉換債券是 2026 年可轉換債券的一部分。因此,我們實際上從損益表總收益中獲得了約 620 萬美元的收益,實際上是以 0.80 美元兌美元購買轉換債券。所以我們正在監控這一點。考慮到回購計劃,我們仍有約 3,600 萬美元需要根據該計劃進行部署。因此,如果我們認為時機正確且有必要的話,我們有能力回購額外的可轉換債務或股權。

  • Operator

    Operator

  • Next question comes from Puneet Souda from Leerink Partners.

    下一個問題來自 Leerink Partners 的 Puneet Souda。

  • Puneet Souda - Senior MD of Life Science Tools and Diagnostics & Senior Research Analyst

    Puneet Souda - Senior MD of Life Science Tools and Diagnostics & Senior Research Analyst

  • So first one on -- wondering if you're getting any feedback from some of the commercial providers, I mean, you said commercial therapies capacity we're hearing sporadically and with different drugs that the supply is constrained on the cell therapy side. I'm sure you have seen that, too. So just sort of trying to get a sense of, is that [gaining] some of the growth in the near term? And how do you see -- what are you hearing from, on your end?

    首先,想知道您是否從一些商業提供者那裡得到任何反饋,我的意思是,您說我們零星聽到的商業治療能力,以及不同藥物的供應在細胞治療方面受到限制。我相信你也看過這一點。所以只是想了解一下,短期內是否會獲得一些成長?你如何看待──你從那一端聽到了什麼?

  • Mark W. Sawicki - Senior VP & Chief Scientific Officer

    Mark W. Sawicki - Senior VP & Chief Scientific Officer

  • Yes, I actually think we're getting over the hump on that, to be honest, Puneet, I mean, the nature of conversation is shifting from manufacturing capacity now to patient accessibility. And that's one of the reasons that we look upstream at the IntegriCell platform that we're building out, is to really drive that patient accessibility and help facilitate scalability as it relates to ensuring that the patients that want the therapy, can get the therapy.

    是的,我實際上認為我們正在克服這個困難,說實話,普尼特,我的意思是,談話的本質正在從現在的製造能力轉向患者的可及性。這就是我們關注正在建構的 IntegriCell 平台上游的原因之一,就是真正推動患者的可及性並幫助促進可擴展性,因為這關係到確保想要治療的患者能夠獲得治療。

  • So I think that's going to become a smaller issue. A lot of the contract manufacturers now don't have -- we don't have these 2- and 3-year backlogs on product requirements or manufacturing backlog. So I think the manufacturing capacity issues, we've largely caught up to it, I think.

    所以我認為這將成為一個較小的問題。許多合約製造商現在沒有——我們沒有這些 2 年和 3 年的產品需求積壓或製造積壓。所以我認為製造能力問題,我們基本上已經解決了。

  • Puneet Souda - Senior MD of Life Science Tools and Diagnostics & Senior Research Analyst

    Puneet Souda - Senior MD of Life Science Tools and Diagnostics & Senior Research Analyst

  • Okay. And then on CRYOPDP and MVE, obviously, a large portion of your revenue is still -- so just wondering if you can provide some guidepost as you're thinking about sort of 2024 in those businesses, anything you could provide would be helpful.

    好的。然後,在CRYOPDP 和MVE 上,顯然,您的收入的很大一部分仍然是- 所以只是想知道您是否可以提供一些指南,因為您正在考慮2024 年這些業務,您可以提供的任何內容都會有所幫助。

  • Jerrell W. Shelton - Chairman, President & CEO

    Jerrell W. Shelton - Chairman, President & CEO

  • Yes. Robert, do you want to take that?

    是的。羅伯特,你想要那個嗎?

  • Robert S. Stefanovich - Senior VP, CFO & Treasurer

    Robert S. Stefanovich - Senior VP, CFO & Treasurer

  • Yes. Look, just in terms of the '24 outlook, we will provide guidance and a more detailed review of the '24 outlook at our year-end earnings call.

    是的。看,就「24 年前景」而言,我們將在年終財報電話會議上提供指導並對「24 年前景」進行更詳細的審查。

  • Look, we've talked about the CRYOPDP business. They have expanded their geographic platform. They've been very strong in Asia Pac and Europe. We fell a little bit short on the U.S. side in terms of driving the revenue synergies between Cryoport Systems and CRYOPDP. That is advancing, and we have taken steps to really enhance that. And you'll hear more about that over the next weeks and months. So that's how far we can go at this point in time, but we'll certainly provide a little bit more of a detailed outlook for '24 at our year-end earnings call.

    看,我們已經討論了 CRYOPDP 業務。他們擴大了地理平台。他們在亞太地區和歐洲非常強大。在推動 Cryoport Systems 和 CRYOPDP 之間的收入協同效應方面,我們在美國方面稍顯不足。這正在取得進展,我們已採取措施來真正加強這一點。在接下來的幾週和幾個月裡,您會聽到更多相關資訊。這就是我們目前能走多遠的地方,但我們肯定會在年終財報電話會議上提供 24 年的更詳細的展望。

  • Puneet Souda - Senior MD of Life Science Tools and Diagnostics & Senior Research Analyst

    Puneet Souda - Senior MD of Life Science Tools and Diagnostics & Senior Research Analyst

  • Okay. And then if I could ask about, there is -- some companies are seeing more expansion in EU versus U.S. in terms of therapies. I'm just wondering if you're seeing any logistical challenges with all the -- obviously, there is the war in Europe and then now the Israel, Gaza situation. So just wondering if you're seeing any disruptions in logistics on that front.

    好的。如果我可以問的話,一些公司在治療方面看到歐盟比美國有更多的擴張。我只是想知道您是否看到任何後勤挑戰 - 顯然,有歐洲戰爭,然後是現在的以色列和加沙局勢。所以想知道您是否看到這方面的物流中斷。

  • Jerrell W. Shelton - Chairman, President & CEO

    Jerrell W. Shelton - Chairman, President & CEO

  • Nothing of significance right now. We've had disruptions in the past. We've -- but there were minor and there's nothing of any significance whatsoever at this point.

    目前沒有什麼重要意義。我們過去曾經遇到過幹擾。我們已經——但有一些小問題,目前沒有任何意義。

  • Operator

    Operator

  • Your next question comes from David Larsen from BTIG.

    您的下一個問題來自 BTIG 的 David Larsen。

  • David Michael Larsen - MD and Senior Healthcare IT & Digital Health Analyst

    David Michael Larsen - MD and Senior Healthcare IT & Digital Health Analyst

  • One more. It looks like your SG&A costs came in maybe up 20% year-over-year. All the companies that I cover have talked about sort of paying aggressive attention to their cost structure. Do you have any thoughts there, Robert or Jerry, I mean it just seems to me like there's a lot of EBITDA potential in the business as it stands now. Just any thoughts around cost containment efforts that I think a lot of folks have been sort of seeing recently.

    多一個。您的 SG&A 成本似乎年增了 20%。我所報導的所有公司都談到了對其成本結構的積極關注。羅伯特或傑瑞,你有什麼想法嗎?我的意思是,在我看來,目前的業務有很大的 EBITDA 潛力。我認為很多人最近都看到了任何有關成本控制工作的想法。

  • Jerrell W. Shelton - Chairman, President & CEO

    Jerrell W. Shelton - Chairman, President & CEO

  • Yes. I'll begin and then Robert can conclude on that question, David. But you're right. There is a lot of EBITDA potential in the SG&A. And that SG&A is inflated because of the number of projects that we have going on. These are all customer-driven, market-driven projects with great potential. And -- but they do have an impact as they're under development on the SG&A, but the potential is enormous. Robert?

    是的。我先開始,然後羅伯特可以對這個問題進行總結,大衛。但你是對的。 SG&A 中有很大的 EBITDA 潛力。由於我們正在進行的項目數量眾多,SG&A 被誇大了。這些都是客戶驅動、市場驅動的項目,潛力巨大。而且,它們確實會對 SG&A 產生影響,因為它們正在開發中,但潛力是巨大的。羅伯特?

  • Robert S. Stefanovich - Senior VP, CFO & Treasurer

    Robert S. Stefanovich - Senior VP, CFO & Treasurer

  • Yes. I will say maybe start -- maybe first with some of the earlier investments we've made that we talked about, some of those investments are starting to pay off now. We talked about the BioStorage, Bioservices revenue that grew 26%, and then also, obviously, building our core solutions in terms of the revenue growth on the commercial side.

    是的。我想說,也許可以開始——也許首先是我們談到的一些早期投資,其中一些投資現在開始獲得回報。我們討論了 BioStorage、生物服務收入成長了 26%,然後,顯然,我們也討論了在商業方面的收入成長方面建立我們的核心解決方案。

  • Noteworthy there is the initiative that we have related to our Cryoport Elite Shipper, supporting Sarepta's commercial launch.

    值得注意的是,我們採取了與 Cryoport Elite Shipper 相關的舉措,支持 Sarepta 的商業發布。

  • So these are initiatives that you've seen over the last years in terms of building out some of these competencies. And then we talked about building out the overall global infrastructure. And really, if you look at the market that we're in and the expected growth that we're seeing, just based on discussions with the clients that we're currently serving in clinical trials and commercial launches, we do know that this will ultimately drive significant revenue. And you're absolutely right. As you see that revenue grow and as you see us leveraging the assets and the capabilities, specifically in the cell and gene therapy space, you'll see that EBITDA margin grow with that as well.

    這些是您在過去幾年中看到的在增強這些能力方面的舉措。然後我們討論了建設全球整體基礎設施。事實上,如果你看看我們所處的市場以及我們所看到的預期成長,僅基於與我們目前在臨床試驗和商業發布中服務的客戶的討論,我們確實知道這將最終帶來可觀的收入。你是完全正確的。當你看到收入成長,當你看到我們利用資產和能力,特別是在細胞和基因治療領域,你會看到 EBITDA 利潤率也隨之成長。

  • So we are very mindful of cash. We're very mindful of spending and ensuring that we have the right ROIs. And it's on our minds and certainly on the investors' minds as you stated. But at the same time, we see a significant opportunity for us, really, to further bolster our leadership position and to capture more wallet share from these customers that are poised to grow quite significantly over the next years.

    所以我們非常注意現金。我們非常注重支出並確保我們擁有正確的投資報酬率。正如您所說,這是我們的想法,當然也是投資者的想法。但同時,我們確實看到了一個重大機會,可以進一步鞏固我們的領導地位,並從這些客戶那裡獲得更多的錢包份額,這些客戶將在未來幾年內大幅成長。

  • Operator

    Operator

  • There are no further questions at this time. Jerry, please proceed with the closing remarks.

    目前沒有其他問題。傑瑞,請繼續致結束語。

  • Jerrell W. Shelton - Chairman, President & CEO

    Jerrell W. Shelton - Chairman, President & CEO

  • First of all, I want to thank all of you for joining the call today and the robust question-and-answer period. There were good questions and that gave us a chance to talk about some very important things.

    首先,我要感謝大家今天參加電話會議並參加精彩的問答環節。有一些很好的問題,這讓我們有機會討論一些非常重要的事情。

  • In closing, our third quarter results were in line with our expectations, showing some growth aspects, particularly in commercial revenue. At the same time, Cryoport has continued to execute on its corporate strategy, increasing its market presence and capabilities through meaningful partnerships and acquisitions. By continuing to execute on this strategy, we believe Cryoport will emerge as an even stronger company that is well positioned to achieve long-term profitable growth.

    最後,我們第三季的業績符合我們的預期,顯示出一些成長方面,特別是在商業收入方面。同時,Cryoport 繼續執行其企業策略,透過有意義的合作夥伴關係和收購來提高其市場影響力和能力。透過繼續執行這項策略,我們相信 Cryoport 將成為一家更強大的公司,並有能力實現長期獲利成長。

  • We thank you for joining us today. We appreciate your continuing support and interest in our company, and we look forward to updating you on our progress again for the fourth quarter very soon. So have a good evening. Thank you very much.

    我們感謝您今天加入我們。我們感謝您對我們公司的持續支持和關注,我們期待很快再次向您通報我們第四季度的進展。所以祝你有一個美好的夜晚。非常感謝。

  • Operator

    Operator

  • Ladies and gentlemen, this concludes today's conference. Thank you for your participation. You may now disconnect.

    女士們、先生們,今天的會議到此結束。感謝您的參與。您現在可以斷開連線。