使用警語:中文譯文來源為 AI 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's fourth quarter and full-year 2025 earnings conference call. (Operator Instructions) As a reminder, this call is being recorded.
下午好,歡迎參加 Cryoport 2025 年第四季暨全年財報電話會議。(接線員指示) 提醒各位,本次通話將被錄音。
I will now turn the call over to your host, Todd Fromer, from KCSA Strategic Communications. Please go ahead.
現在我將把電話交給本次會議主持人——來自 KCSA Strategic Communications 的 Todd Fromer。請開始。
Todd Fromer - Investor Relations
Todd Fromer - Investor Relations
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 all forward-looking statements.
謝謝,接線員。在我們今天開始之前,我想提醒各位,本次電話會議包含若干前瞻性陳述。所有涉及我們營運表現,以及我們預期或預估未來將發生之事件或發展的陳述,均屬前瞻性陳述。
These forward-looking statements are based on management's beliefs and assumptions and not on 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.
這些前瞻性陳述係基於管理層的信念與假設,而非基於目前可供我們管理團隊取得的資訊。我們管理團隊相信,這些前瞻性陳述在作出時均屬合理。然而,您不應過度依賴任何此類前瞻性陳述,因為此類陳述僅反映其作出當日之情況。除法律要求外,我們不承擔公開更新或修訂任何前瞻性陳述之義務,不論係因新資訊、未來事件或其他原因。
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 to be 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,前瞻性陳述亦受若干風險與不確定性影響,可能導致實際結果、事件與發展與我們的歷史經驗及目前預期或預測存在重大差異。此等風險與不確定性包括但不限於:我們將向美國證券交易委員會提交之 Form 10-K 年度報告中第 1A 項「風險因素」及其他部分所述者,以及我們不時向美國證券交易委員會提交之其他報告中所述者。
As a reminder, Cryoport has uploaded their fourth quarter and full-year 2025 in review document to the main page of the Cryoport Inc., website. This document provides a review of Cryoport's financial and operational performance and a general business outlook.
提醒各位,Cryoport 已將其「2025 年第四季暨全年回顧」文件上傳至 Cryoport Inc. 官網首頁。該文件提供 Cryoport 財務與營運表現回顧,以及一般性的業務展望。
Before I turn the call over to Jerry, please note that because of the strategic partnership that has been established with DHL and related sale of CRYOPDP to DHL, CRYOPDP's financials, which were previously a part of Cryoport's Life Sciences Services reportable segment, are now presented as discontinued operations.
在我把電話交給 Jerry 之前,請注意:由於已與 DHL 建立策略合作夥伴關係,並將 CRYOPDP 相關業務出售予 DHL,原先屬於 Cryoport「生命科學服務」可報告部門一部分的 CRYOPDP 財務資訊,現已列示為終止營業。
Cryoport previously provided quarterly historical information on this basis for fiscal year 2024 and our first-quarter 2025 in review document, which remains available on the Cryoport Inc., website. This information is intended to support the financial modeling efforts of those needing this type of information.
Cryoport 先前已就 2024 財政年度及「2025 年第一季回顧」文件,按此基礎提供季度歷史資訊;該文件仍可於 Cryoport Inc. 官網取得。此資訊旨在支援需要此類資訊者之財務建模工作。
Please note that unless otherwise indicated, all revenue figures discussed today will refer to continuing operations. This includes Cryoport's fiscal year 2025 revenue guidance.
請注意,除非另有說明,今天討論的所有營收數字均指持續營業。這也包括 Cryoport 2025 財政年度的營收指引。
It is now my pleasure to turn the call over to Mr. Jerrell Shelton, Chief Executive Officer of Cryoport. Jerry, the floor is yours.
現在我很高興把電話交給 Cryoport 執行長 Jerrell Shelton 先生。Jerry,請開始。
Jerrell Shelton - Chairman of the Board, President, Chief Executive Officer
Jerrell Shelton - Chairman of the Board, President, Chief Executive Officer
Thank you, Todd. We have a great report for you today, ladies and gentlemen. But before we begin, 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.
謝謝你,Todd。各位女士、先生,今天我們將為各位帶來一份非常好的報告。不過在開始之前,今天下午與我們一同出席的還有:財務長 Robert Stefanovich;首席科學長 Mark Sawicki 博士;以及企業發展與投資人關係副總裁 Thomas Heinzen。
Today, we reported our full-year results for 2025, which was a year of strong progress for Cryoport. We delivered full-year revenue from continuing operations of $176.2 million, exceeding the high end of our prior guidance and reflecting continued momentum across our core markets. In the fourth quarter, we again achieved double-digit growth driven by expanding commercial cell and gene therapy activity and revenue from the support of commercial cell and gene therapy, increasing 29% year over year to a record $33.4 million for the year.
今天我們公布了 2025 年全年業績,對 Cryoport 而言,這是一個取得強勁進展的一年。我們持續營業的全年營收達 1.762 億美元,超越先前指引區間的上緣,並反映我們核心市場動能持續增強。在第四季,我們再次達成雙位數成長,主要受商業化細胞與基因治療活動擴張所帶動;而來自商業化細胞與基因治療支援的營收年增 29%,全年創下 3,340 萬美元的新高。
Commercial cell and gene therapy revenue in the fourth quarter represented 20% of our overall revenue. While clinical trial revenue remains solid, growing 14% year over year to $47.1 million. We concluded 2025 supporting a record 760 clinical trials and 20 commercial therapies worldwide. Our clinical trial support showed a net increase of 59 over the previous year and represented approximately 70% of total trials for the cell and gene therapy industry.
第四季商業化細胞與基因治療營收占我們總營收的 20%。同時,臨床試驗營收仍然穩健,年增 14% 至 4,710 萬美元。我們在 2025 年底支援了全球創紀錄的 760 項臨床試驗與 20 項商業化療法。我們的臨床試驗支援較前一年淨增加 59 項,約占細胞與基因治療產業總試驗數的 70%。
Looking ahead to 2026, based on the information that we have, we anticipate another 13 BLA or MAA application filings, including two of which have already been filed, nine new therapy approvals and an additional two approvals for label or geographic expansion.
展望 2026 年,根據我們目前掌握的資訊,我們預期將有另外 13 件 BLA 或 MAA 申請送件,其中已有 2 件完成送件;並預期有 9 項新療法獲批,以及另外 2 項標籤或地理範圍擴張的核准。
In the near term, Cryoport has three customers that are anticipating new therapy approval decisions in March and April of this year. We believe our clinical trial pipeline is spring loaded, with 86 clinical trials in Phase 3 and 361 trials in Phase 2. Remember, most of the cell therapies that were approved today were from Phase 2. In our opinion, this market-leading base will drive the growth of our commercial revenue in the near and the long term.
就短期而言,Cryoport 有 3 位客戶預期將在今年 3 月與 4 月迎來新療法核准決定。我們認為臨床試驗管線已蓄勢待發,目前有 86 項第三期臨床試驗與 361 項第二期試驗。請記得,目前已獲核准的多數細胞療法都源自第二期試驗。我們認為,這個市場領先的基礎將在短期與長期推動我們商業化營收的成長。
We continue to execute on our mission of expanding services to the life sciences by broadening our revenue streams and capturing more revenue per client. For 2025 revenue Life Sciences Services segment increased 18% year over year, including 22% growth in BioStorage, BioServices revenue. Our performance reflects the expanding scale and scope of the clinical and commercial programs we support and the trust our customer's place and our comprehensive end-to-end supply chain solutions.
我們持續執行擴展生命科學服務的使命,透過拓寬營收來源並提高每位客戶的營收貢獻。2025 年生命科學服務部門營收年增 18%,其中 BioStorage、BioServices 營收成長 22%。我們的表現反映了我們所支援之臨床與商業化專案規模與範疇的擴大,以及客戶對我們端到端供應鏈解決方案的信任。
While our primary focus remains on accelerating revenue growth and strengthening our market position, we continue to enhance our operational discipline along across the organization as we advance on our pathway to profitability. In '25, our cost reduction initiatives contributed to our gross margin of 47%, accompanied by a $12 million year-over-year improvement and adjusted EBITDA. With our progress to date, we anticipate achieving positive adjusted EBITDA in the second half of 2026.
雖然我們的首要重點仍是加速營收成長並強化市場地位,但在邁向獲利的道路上,我們也持續在全組織範圍內提升營運紀律。在 2025 年,我們的成本削減措施促成 47% 的毛利率,並帶來調整後 EBITDA 年增改善 1,200 萬美元。依據目前進展,我們預期將在 2026 年下半年達成調整後 EBITDA 轉正。
Turning to our Life Sciences Product segment, revenue grew 7% year over year in 2025. MVE Biological Solutions focused on execution and innovation and continues to further enhance its position as the global leader in the production of high-quality cryogenic systems.
再看我們的生命科學產品部門,2025 年營收年增 7%。MVE Biological Solutions 專注於執行與創新,並持續強化其作為全球高品質低溫系統生產領導者的地位。
Recently, MVE launched its integrated condition monitoring solutions for its dry vapor shippers. These novel condition monitoring solutions are integrated with each doer, combining MVE's trusted cryogenic systems with advanced real-time conditioning, monitoring technologies supplied by Tec4med, another cloud4 company. This system communicates with MVE's new cryoverse, a cloud-based data capture and shipment management system.
近期,MVE 為其乾式氣相運輸箱推出整合式狀態監測解決方案。這些新型狀態監測解決方案與每一台 doer 整合,將 MVE 值得信賴的低溫系統與由 Tec4med(另一家 cloud4 公司)提供的先進即時狀態監測技術結合。該系統可與 MVE 全新的 cryoverse 進行通訊;cryoverse 是一套雲端資料擷取與運輸管理系統。
More recently, ME launched its Fusion 800 series, a revolutionary, self-sustaining, cryogenic freezer that can fit through a single door, which opens up substantial market opportunities. These revolutionary cryogenic freezers eliminate the need for continuous liquid nitrogen supply, delivering exceptional reliability, safety, and sustainability in a compact footprint that is designed for settings where there is limited space and no readily available sources of liquid nitrogen.
更近期,ME 推出了 Fusion 800 系列——一款革命性的自給式低溫冷凍櫃,可通過單扇門進出,從而開啟可觀的市場機會。這些革命性的低溫冷凍櫃免除持續供應液態氮的需求,在占地精巧的設計下提供卓越的可靠性、安全性與永續性,特別適用於空間有限且不易取得液態氮來源的環境。
At Cryoport Systems, we increased our internal investments to support the traction that we are seeing across our broad portfolio of cell and gene therapy clients. These strategic investments include the completion of our global supply chain center in Paris, France; the expansion of our Belgian operations to accommodate a key commercial client; and continuing the buildout of a global supply chain center in Santa Ana, California, which consolidates three existing facilities into a single expanded campus and enhances our service capabilities.
在 Cryoport Systems,我們提高了內部投資,以支援我們在廣泛的細胞與基因治療客戶組合中所看到的成長動能。這些策略性投資包括:完成位於法國巴黎的全球供應鏈中心;擴增比利時營運以容納一位關鍵商業化客戶;以及持續建置位於加州聖塔安娜的全球供應鏈中心,該中心將三處既有設施整併為單一擴大的園區,並提升我們的服務能力。
Of course, one topic of the day is AI. As a part of our overall digital strategy, we are actively leveraging generative AI to enhance internal workflows and day-to-day operations. Our focus is on enabling employees to use secure enterprise approved Generative AI tools to reduce manual task, accelerate execution, and improve accuracy and consistency of outcomes. These focused efforts emphasized practical adoption through education, hands-on support, and real production use cases dive directly to current business needs. There is no doubt that AI is reshaping our business and will play a significant role in our future.
當然,今天的一個話題是 AI。作為我們整體數位策略的一部分,我們正積極運用生成式 AI 來強化內部工作流程與日常營運。我們的重點在於讓員工能使用安全、經企業核准的生成式 AI 工具,以減少人工任務、加速執行,並提升成果的準確性與一致性。這些聚焦的努力,透過教育訓練、實作支援,以及直接對應當前業務需求的實際生產環境案例,強調務實導入。毫無疑問,AI 正在重塑我們的業務,並將在我們的未來扮演重要角色。
In 2025, we reported a strategic partnership with DHL Group which included DHL's acquisition of CRYOPDP. This action was completed in the second quarter of 2025 and provided Cryoport with a substantial capital infusion. Over time, we expect this relationship to enhance our position in APAC and EMEA regions and strengthen our competitive industry profile by leveraging the global scale and capabilities of this key strategic partner.
在 2025 年,我們公布了與 DHL 集團的策略合作夥伴關係,其中包括 DHL 收購 CRYOPDP。此項交易已於 2025 年第二季完成,並為 Cryoport 帶來可觀的資金挹注。隨著時間推進,我們預期此合作將強化我們在亞太(APAC)與歐洲、中東及非洲(EMEA)地區的布局,並藉由這位關鍵策略夥伴的全球規模與能力,提升我們在產業中的競爭定位。
As a part of our continuing strategic initiatives to embed our market-leading solutions in the cell and gene therapy ecosystem and improve our growth trajectory, we expanded our global partnerships by entering into strategic collaborations with Cardinal Health and Parexel. Both companies are leveraging Cryoport system's supply chain solutions in support of their complimentary offerings in the cell and gene therapy space. These partnerships reinforce our position as a market leader in this space and the industry's drive to standardize.
作為我們持續推動的策略計畫之一,為了將我們的市場領先解決方案更深度嵌入細胞與基因治療生態系並改善成長軌跡,我們透過與 Cardinal Health 與 Parexel 建立策略合作,擴大了全球合作夥伴關係。兩家公司皆運用 Cryoport 系統的供應鏈解決方案,以支援其在細胞與基因治療領域的互補性服務/產品。這些合作夥伴關係強化了我們在該領域的市場領導地位,也呼應產業推動標準化的趨勢。
As we enter 2026 and consider global macro puts and takes, we believe that our full revenue guidance -- our full-year revenue guidance of $190 million to $194 million is an appropriate starting point for the year. On the second point, we anticipate achieving positive adjusted EBITDA in the second half of 2026.
在我們邁入 2026 年並考量全球總體環境的利弊因素之際,我們認為我們的全年營收指引——全年營收指引為 1.90 億至 1.94 億美元——是本年度一個適切的起點。第二點,我們預期在 2026 年下半年達成調整後 EBITDA 轉正。
There's a lot coming into focus for us. We're very excited about our prospects for 2026 and intend to capitalize on our current momentum; leadership position as the only pure play; temperature-control supply chain integrated platform supporting the Life Sciences industry's largest portfolio of clinical and commercial cell and gene therapies.
對我們而言,許多事情正逐漸明朗。我們對 2026 年的前景感到非常振奮,並打算把握目前的動能;憑藉我們作為唯一純粹專注於溫控供應鏈整合平台的領導地位,支援生命科學產業中最大規模的臨床與商業化細胞與基因治療產品組合。
This concludes my remarks, and I now will turn the call over to the operator to open the lines for your questions and our discussion.
以上為我的發言,接下來我將把電話會議交給接線員,開放線路供各位提問並進行討論。
Operator
Operator
(Operator Instructions) Puneet Souda, Leerink Partners.
(接線員指示) Leerink Partners 的 Puneet Souda。
Puneet Souda - Analyst
Puneet Souda - Analyst
So first one, Jerry or maybe for Robert, the guide that you have, high single-digit, nearly 9% of midpoint for the year, could you elaborate a bit more on that? And in terms of the segments, how should we think about the growth and biologics and the services and the MVE? And given the commercial momentum -- commercial therapy momentum that you're seeing, how should we think about that growth for the full year? And I have a follow-up.
第一個問題,Jerry 或也許 Robert:你們給出的指引,全年中位數約為接近 9% 的高個位數成長,能否再多說明一些?就各事業部而言,我們應如何看待 Growth & Biologics、Services 以及 MVE 的表現?另外,考量你們看到的商業化動能——商業化療法的動能——我們應如何看待全年成長?我還有一個追問。
Jerrell Shelton - Chairman of the Board, President, Chief Executive Officer
Jerrell Shelton - Chairman of the Board, President, Chief Executive Officer
Okay. So there's several questions in that request, Puneet. So I'd like to start to kind of parse those questions. So your question, the first one is how we feel about the -- was your last point about how we feel about the growth of cell and gene therapy for 2026. Is that correct?
好的。Puneet,你這個提問裡包含了幾個問題。我想先把這些問題拆開來回答。所以你的第一個問題是我們對——你最後一點是問我們如何看待 2026 年細胞與基因治療的成長。是這樣嗎?
Puneet Souda - Analyst
Puneet Souda - Analyst
Yeah. More on the commercial side. I mean, what's your growth expectation for commercial therapies? And then also, if you can provide more color on the segments -- each of the segments, the BioLogistics, the BioStorage, and then the --
是的。更偏向商業化端。我的意思是,你們對商業化療法的成長預期是什麼?另外,如果可以的話,也請就各個事業部提供更多細節——BioLogistics、BioStorage,然後還有--
Jerrell Shelton - Chairman of the Board, President, Chief Executive Officer
Jerrell Shelton - Chairman of the Board, President, Chief Executive Officer
Okay. So I'm going to start with the last question first, and I'm going to turn it over to Mark, okay? Because he has a view on this.
好的。那我先從最後一個問題開始,然後我會交給 Mark,好嗎?因為他對這部分有他的看法。
But we do expect continued progress for our existing customers and we do expect to be bringing on other commercial therapies during the year. It does take time for them to ramp up, but they will have impact. And some of those that we've already brought on will have a continuing impact. And Mark can name some of those names, perhaps, but we do try to avoid directly commenting on customers' business. So in general, let me turn it over to Mark and let him answer the rest of that.
不過,我們確實預期既有客戶將持續取得進展,也預期在年度內會導入其他商業化療法。它們需要一些時間爬坡放量,但會帶來影響。而我們已經導入的一些項目也會持續產生影響。Mark 或許可以提到其中一些名稱,但我們通常會避免直接評論客戶的業務。總之,我把其餘部分交給 Mark 來回答。
Mark Sawicki - Senior Vice President, Chief Scientific Officer
Mark Sawicki - Senior Vice President, Chief Scientific Officer
Yeah. So Puneet, obviously, we typically don't furnish guidance on composition by type. We did increase our commercial revenue by 29% in 2025 and it's now eclipsing 20% of our overall revenue. Looking at '26, we do expect to have another good year in '26, although we haven't disclosed the percentages associated with the commercial revenue at this point.
是的。Puneet,很明顯地,我們通常不會提供按類型拆分的組成指引。我們在 2025 年將商業化營收提高了 29%,目前商業化營收已超過我們總營收的 20%。展望 2026 年,我們預期 2026 年仍會是表現不錯的一年,儘管目前我們尚未揭露商業化營收所對應的百分比。
Jerrell Shelton - Chairman of the Board, President, Chief Executive Officer
Jerrell Shelton - Chairman of the Board, President, Chief Executive Officer
And Puneet, there's no doubt about it that commercial therapy will be the driver of our future. I mean, it is the fastest-growing market, and as I mentioned earlier, we're forecasting new therapies in 2026 and we're -- furthermore, we're forecasting 11 BLA/MAA filings to take place.
而且 Puneet,毫無疑問,商業化療法將是我們未來的成長驅動力。我的意思是,這是成長最快的市場;如我先前提到的,我們預期 2026 年會有新的療法推出;此外,我們也預期將有 11 件 BLA/MAA 申請遞交。
And as I mentioned in my comments, we think we're spring loaded. We have 86 trials in Phase 3 and then we have that -- I think there's 391 in Phase 2. So we're spring loaded for a brilliant future. Even if half of those in Phase 3 are approved, it's fantastic for us.
如我在發言中提到的,我們認為我們已蓄勢待發。我們有 86 項第三期試驗,另外——我想第二期大約有 391 項。因此我們已為非常亮眼的未來做好準備。即使第三期中只有一半獲批,對我們而言也非常可觀。
Mark Sawicki - Senior Vice President, Chief Scientific Officer
Mark Sawicki - Senior Vice President, Chief Scientific Officer
And maybe just to add to it, we've grown in all of our service lines and we've grown all our product side as well. We expect to continue to see growth really in all of our product lines and service lines. And we always talk about services growing double-digit as commercial therapy being the strong grower within that. And then on the product side, single-digit growth, mid-single-digit growth, potentially high single-digit growth depending on how the demand is coming.
再補充一下,我們在所有服務線都有成長,產品端也同樣成長。我們預期在所有產品線與服務線都會持續看到成長。我們一向提到服務會維持雙位數成長,其中商業化療法是最強的成長動能。而在產品端,我們預期為個位數成長、中個位數成長;視需求而定,也可能達到高個位數成長。
Jerrell Shelton - Chairman of the Board, President, Chief Executive Officer
Jerrell Shelton - Chairman of the Board, President, Chief Executive Officer
So on your second part of your question -- Puneet, if I missed anything or we've missed anything, you can come back. But second part of your question on BioStorage, BioServices. BioStorage, BioServices grew by 22% for this past year. We're very pleased with that. And it will continue to grow. In fact, we think it will pick up growth; I'm certain about that. And of course, it is driven by cell therapy approvals. So it's a bright future for BioStorage, BioServices.
所以回到你問題的第二部分——Puneet,如果我漏了什麼或我們有遺漏,你可以再補充。你第二部分關於 BioStorage、BioServices 的問題。BioStorage、BioServices 在過去一年成長了 22%。我們對此非常滿意。而且它會持續成長。事實上,我們認為成長會加速;我對此很有把握。當然,這主要由細胞治療的核准所驅動。因此,BioStorage、BioServices 的前景非常光明。
The third part of the question. Go ahead.
第三部分的問題。請繼續。
Puneet Souda - Analyst
Puneet Souda - Analyst
Yeah. Just on the MVE segment too, I mean, you had 2% growth, I believe, in the quarter and correct me if I'm wrong. And how should we think about --
是的。也想問一下 MVE 事業部,我記得你們該季成長 2%,如果我說錯請糾正。那我們應該如何看待--
Jerrell Shelton - Chairman of the Board, President, Chief Executive Officer
Jerrell Shelton - Chairman of the Board, President, Chief Executive Officer
Yeah. We were up 7% for the year. And MVE is doing well. I mean, it's got -- we try to create these fountains of innovation throughout the company to make sure that we're moving ahead. The MVE has introduced its -- the integrated monitoring systems that I mentioned during my comments, but more important -- equally important are the things that will be introduced in this next quarter or in this quarter as a matter of fact. And so -- and we've introduced the [crowbar].
是的。我們全年成長了 7%。而 MVE 表現良好。我的意思是——我們試著在公司各處打造這些創新泉源,以確保我們持續向前。MVE 已推出我在發言中提到的整合式監控系統,但更重要——同樣重要的是,將在下一季或其實就在本季推出的項目。因此——而且我們也推出了[crowbar]。
So you're going to see MVE also adding some services to the product that is producing, but remember that Fusion 800 opens up a vast new market for us. Vast because there are many facilities on second floors in countries around the world that can't get a large freezer on that second floor that need a large cryogenic freezer. Hospital pharmacies will like this product as we move forward and these allogeneic therapies are developed.
所以你會看到 MVE 也在為正在生產的產品增加一些服務,但請記住,Fusion 800 為我們開啟了一個龐大的新市場。之所以說龐大,是因為全球許多國家的二樓設施無法把大型冷凍庫搬上二樓,但又需要一台大型低溫冷凍庫。隨著我們持續推進、並且這些同種異體療法逐步開發出來,醫院藥局會很喜歡這項產品。
Puneet Souda - Analyst
Puneet Souda - Analyst
Got it. Super. And then just a quick clarification on Q1. Any color you can provide there would be helpful. Just -- and I wanted to know if there are any flight cancellations, disruptions from any of the geopolitical flight cancellations that you're expecting in Q1. Thank you.
了解。很好。接著想快速釐清一下第一季(Q1)。你能提供的任何補充說明都會很有幫助。另外我想了解,針對第一季,你們是否預期會因地緣政治導致的航班取消而出現任何取消或中斷?謝謝。
Jerrell Shelton - Chairman of the Board, President, Chief Executive Officer
Jerrell Shelton - Chairman of the Board, President, Chief Executive Officer
There's nothing that we're expecting in terms of cancellations, and today, there's been minimal impact on us. So nothing to report there at this time.
就取消而言,我們目前沒有預期會發生任何情況,而且截至今天,對我們的影響也很小。所以目前沒有需要回報的事項。
Puneet Souda - Analyst
Puneet Souda - Analyst
Got it. And then color on Q1?
了解。那第一季的補充說明呢?
Jerrell Shelton - Chairman of the Board, President, Chief Executive Officer
Jerrell Shelton - Chairman of the Board, President, Chief Executive Officer
Yeah, we've had a solid start to Q1, Puneet. We're not expecting a light one like some other Life Science companies are.
是的,Puneet,我們第一季開局很穩健。我們不預期會像其他一些生命科學公司那樣出現偏淡的第一季。
Operator
Operator
Anna Snopkowski, KeyBanc Capital Markets.
Anna Snopkowski,KeyBanc Capital Markets。
Anna Snopkowski - Analyst
Anna Snopkowski - Analyst
Congrats on a great quarter, and a nice guide for '26. So maybe to start, you mentioned in your prepared remarks that total biopharma funding and CGT funding in particular saw the strongest funding month in December in the past four years, I believe. So I was wondering what the usual lag is between the funding environment and maybe your customer conversations or orders. And then a quick follow-up. Thank you.
恭喜本季表現很出色,且對 2026 年的指引也很不錯。我想先從你在事先準備的發言中提到的一點開始:總體生物製藥融資、尤其是 CGT(細胞與基因治療)融資,在我記得是過去四年中,12 月出現了最強的單月融資。所以我想請教,融資環境的變化,通常會延遲多久才會反映在你們與客戶的對話或訂單上?接著我還有一個快速追問。謝謝。
Jerrell Shelton - Chairman of the Board, President, Chief Executive Officer
Jerrell Shelton - Chairman of the Board, President, Chief Executive Officer
Yeah. So obviously, funding is dependent on the client, but on average, you'll typically see that kick in after about a half a year timeframe, some may be a little bit quicker, some may be a little bit slower, but it's a good average for you to consider.
好的。很明顯,融資狀況會因客戶而異,但平均而言,你通常會在大約半年後看到影響開始顯現;有些可能更快一些,有些可能慢一些,但這是一個你可以參考的合理平均值。
Anna Snopkowski - Analyst
Anna Snopkowski - Analyst
Okay, perfect. And then maybe just touching on the margin side of things. You mentioned that you expect positive adjusted EBITDA I think in the second half of '26. So could you just outline how you expect to get there and what operational or cost reduction milestones need to happen in order to achieve this? Thank you.
好的,太好了。接著想談一下毛利率/利潤率方面。你提到你們預期在 2026 年下半年實現正的調整後 EBITDA。你能否概述一下你們預計如何達成,以及需要完成哪些營運或成本降低的里程碑才能實現?謝謝。
Jerrell Shelton - Chairman of the Board, President, Chief Executive Officer
Jerrell Shelton - Chairman of the Board, President, Chief Executive Officer
Yeah. It's really less about cost reduction milestones. You may recall in '24 early '25, we did take some initiatives and operational initiatives to drive improvements, and that was, you know, quite successful. We improved adjusted EBITDA about $12 million year over year. We are starting to invest in specific growth initiatives and completing some of the initiatives that we commenced in 2025 in setting up our global supply chain center in Paris and setting up our global supply chain center in California, which is going to consolidate three locations and expand our footprint there to include BioServices and IntegriCell.
好的。這其實比較不是成本降低里程碑的問題。你可能記得在 2024 年到 2025 年初,我們確實採取了一些措施與營運改善計畫來推動提升,而且相當成功。我們的調整後 EBITDA 年增改善了約 1,200 萬美元。我們正開始投資於特定的成長計畫,並完成一些我們在 2025 年啟動的專案,包括在巴黎設立全球供應鏈中心,以及在加州設立全球供應鏈中心;該中心將整併三個據點,並擴大我們在當地的布局,納入 BioServices 與 IntegriCell。
We also have a lot of insight with our client base. If you kind of step back and look at how weâre positioned, itâs really an unmatched positioning. We serve about 70% of clinical trials, have a record 670 clinical trials, and we support 20 commercially approved therapies for which a majority are cell therapies. So we have a lot of insight as to whatâs to come. Weâve been very successful in expanding our service offerings into BioServices where weâve seen strong growth. And so, that expected growth, together with some of the efficiencies that weâve identified, will really drive the further margin improvement.
我們也從客戶基礎獲得了大量洞察。如果你退一步看我們的定位,這真的是無可匹敵的定位。我們服務約 70% 的臨床試驗,臨床試驗數量創下 670 項的紀錄,並且我們支援 20 項已獲商業核准的療法,其中多數是細胞療法。因此,我們對未來趨勢有很多洞察。我們在將服務擴展到 BioServices 方面非常成功,並看到強勁成長。因此,這些預期成長,加上我們已識別的一些效率提升,將真正推動利潤率進一步改善。
Mark Sawicki - Senior Vice President, Chief Scientific Officer
Mark Sawicki - Senior Vice President, Chief Scientific Officer
Yeah. I just want to comment on the push out of the adjusted EBITDA positive numbers out of the end of Q25. So one of the key elements here is that weâve seen specific client requests to accelerate certain business opportunities, and so our site in Belgium is a very good example of that where we had to build out in a very rapid timeframe GMP compliant sterile kitting services for one of the very large volume commercial accounts. That is actually up and running. So we were able to do this in record time, commission the site in December, and it is now contributing revenue, which will ramp significantly over the next few years. So we do still have to remain a little bit opportunistic on these types of opportunities because theyâll benefit the organization in the long term.
是的。我想補充一下,關於把調整後 EBITDA 轉正的時間點推遲到 2025 年底(Q25 末)。其中一個關鍵因素是,我們看到特定客戶要求加速某些商機;比利時據點就是很好的例子,我們必須在非常短的時間內,為某個超大量的商業客戶建置符合 GMP 的無菌組裝(sterile kitting)服務。該據點其實已經啟用並運轉。因此我們能在創紀錄的時間內完成,於 12 月完成場地驗收/啟用(commission),目前已開始貢獻營收,且未來幾年將顯著爬坡。所以我們仍需要在這類機會上保持一定的機動性,因為長期而言它們會讓組織受益。
Operator
Operator
Subbu Nambi, Guggenheim Securities.
Subbu Nambi,Guggenheim Securities。
Subbu Nambi - Equity Analyst
Subbu Nambi - Equity Analyst
Within the 2026 guidance, can you speak to what you expect from the macroenvironment or at the low end and the high end of your revenue guidance range?
在 2026 年指引之內,你能談談你們對總體環境的預期嗎?以及在你們營收指引區間的低端與高端,各自反映了什麼假設?
Robert Stefanovich - Chief Financial Officer, Senior Vice President, Chief Administrative Officer
Robert Stefanovich - Chief Financial Officer, Senior Vice President, Chief Administrative Officer
In terms of -- I mean, obviously, if you look at the macroenvironment, itâs quite volatile. If you look at specifically the markets that weâre addressing, those have been progressing very nicely in spite of some of the challenges within the regulatory agencies and the macroenvironment. If you look at clinical trials, we had a record increase year over year in clinical trials, and we see a lot of interest for the services that weâre providing.
就——我的意思是,顯然如果你看總體環境,它相當波動。但如果你看我們所鎖定的市場,即使監管機構與總體環境存在一些挑戰,這些市場仍然進展得很好。如果你看臨床試驗,我們的臨床試驗數量年增創下紀錄,我們也看到市場對我們所提供服務有很高的興趣。
So I think thereâs certainly an opportunity to beat the guidance that weâre giving if we see some of the acceleration happening sooner. I think the downside risk is really the same thing as for all other companies. Itâs more of the unknown of what may happen. We donât really have specific risks identified at this point in time, and we feel quite comfortable with the guidance that weâre providing.
所以我認為,如果我們看到某些加速更早發生,確實有機會超越我們目前給出的指引。我認為下行風險其實和其他公司一樣。更多是對於可能發生什麼的未知數。目前我們沒有識別到特定風險,我們對所提供的指引也相當有信心。
Subbu Nambi - Equity Analyst
Subbu Nambi - Equity Analyst
Thank you for that. As a follow-up, you discussed the outlook for FDA approvals, but what is assumed in the guidance for animal health and reproductive health growth contributions?
謝謝你的說明。追問一下,你談到了 FDA 核准的展望,但在指引中,對動物健康與生殖健康的成長貢獻是如何假設的?
Jerrell Shelton - Chairman of the Board, President, Chief Executive Officer
Jerrell Shelton - Chairman of the Board, President, Chief Executive Officer
Yeah. Itâs moderate growth. I think the real growth drivers, you know, for us as a business is clearly the cell and gene therapy space on the services side. And then within that, in terms of growth drivers, itâs really further advancing the commercial cell therapies. Thereâs a number of activities, some happen in 2025. The removal of the REMS requirement, which really started to -- we started to see our clients accelerating their therapies into the outpatient setting. And thatâs a significant move which portends to higher number of patients being treated, and that again translates into additional revenue to us.
好的。是溫和成長。我認為對我們這個業務而言,真正的成長驅動因素,顯然是在服務端的細胞與基因治療領域。而在其中,就成長驅動因素來看,主要是進一步推進商業化細胞療法。有一些活動,其中部分發生在 2025 年。例如移除 REMS 要求,這確實開始——我們開始看到客戶加速把他們的療法推進到門診場景。這是一個重大轉變,意味著會有更多病患接受治療,而這也會轉化為我們的額外營收。
Operator
Operator
David Saxon, Needham.
David Saxon,Needham。
David Saxon - Equity Analyst
David Saxon - Equity Analyst
Just two for me. Wanted to follow up on some of the comments earlier about product growth. I think last quarter, you were kind of feeling good about high single digits for '26. Sounds like you might be thinking more around mid-single digit growth for the year. So can you just give an update on MVE, the pipeline, the outlook there? Like was there any incremental softening since last quarter? Or is that just kind of conservatism baked in?
我這邊兩個問題。想追問先前一些關於產品成長的評論。我記得上季你們對 2026 年的高個位數成長感覺不錯。聽起來你們現在可能更偏向全年中個位數成長。所以你能否更新一下 MVE、產品管線以及那邊的展望?相較上季是否有任何額外的走弱?還是只是把保守性納入假設?
Jerrell Shelton - Chairman of the Board, President, Chief Executive Officer
Jerrell Shelton - Chairman of the Board, President, Chief Executive Officer
David, I think that we pretty much addressed that. We think our guidance is a good starting point for the year. There are a lot of macro risk out there and we did assess those. And so, our starting point for our guidance is that $190 million to $194 million, and we think itâs a good starting point.
David,我認為我們基本上已經回應了那點。我們認為我們的指引是今年一個良好的起點。外部存在許多總體經濟風險,我們也已評估過。因此,我們指引的起點是1.90億至1.94億美元,我們認為這是個不錯的起點。
MVE continues to work on a stabilized basis. Itâs got a great forecast, a budget for 2026, and it has innovation coming out of it on a constant basis now. So we think MVE is in good condition, but weâre not forecasting growth more than the higher single digits, 7% to 8%.
MVE 持續以穩定化的基礎運作。它有很好的預測、2026年的預算,而且現在持續不斷地推出創新。所以我們認為 MVE 狀況良好,但我們不預測成長會高於較高的個位數,也就是7%到8%。
David Saxon - Equity Analyst
David Saxon - Equity Analyst
Okay. Thatâs super helpful. Thanks, Jerry. And then wanted to follow up on some of the partnerships. Obviously, DHL, I guess can you give an update there? Like is everything fully integrated and at a point where you can start to really see the benefits come through?
好的。這非常有幫助。謝謝,Jerry。接著我想追問一些合作夥伴關係。顯然是 DHL,我想你能否提供一下最新進展?例如是否已經完全整合,並且到了你們可以真正開始看到效益逐步顯現的階段?
And then you also mentioned Cardinal and Parexel. Can you just double-click there? Like frame those and --
另外你也提到了 Cardinal 和 Parexel。你能否再深入說明一下?例如把它們的定位說清楚,並且--
Jerrell Shelton - Chairman of the Board, President, Chief Executive Officer
Jerrell Shelton - Chairman of the Board, President, Chief Executive Officer
Yeah. Look, DHL is a lumbering -- big lumbering organization. And I want to go back to one of your points, your question a little bit earlier, comment, but after I talk about this. But DHL is a large -- very large organization, 600,000 employees spread all over the world. It takes time for them to mobilize and to -- and they canât operate as agilely as we do.
是的。你看,DHL 是一個龐大而運作較為遲緩的——非常龐大、運作較為遲緩的組織。我想在談完這個之後,再回到你稍早提到的一個觀點、也就是你之前的問題/評論。但 DHL 是一個大型——非常大型的組織,全球各地有60萬名員工。他們要動員起來需要時間,而且——而且他們無法像我們一樣敏捷地運作。
So itâs going to take time for that relationship. Thatâs why I said the promise of -- in terms of EMEA and Asia Pac and that impact, we are doing some things with them already. And we do have some cooperative endeavors underway. But for the full effect, itâs going to take a while for that to roll out.
所以這段關係需要時間。這也是為什麼我說,就 EMEA 與亞太地區以及其影響而言,這個合作的承諾——我們已經在和他們做一些事情了。而且我們確實已有一些合作項目在進行中。但要看到完整效果,全面推展還需要一段時間。
Iâm going to let Mark comment on Cardinal and Parexel. But before we do that, you were talking about MVE and the 7% growth and all that kind of stuff. I just want you to remember, the driver for this company is commercialized cell and gene therapies. And as that happens, that will dwarf MVE.
我會讓 Mark 來談 Cardinal 和 Parexel。但在那之前,你剛才談到 MVE、7%的成長以及諸如此類的內容。我只想提醒你,這家公司的驅動力是已商業化的細胞與基因療法。而隨著那件事發生,它的規模將遠遠超過 MVE。
MVE is a crucial part of our business. Itâs a foundational business. Itâs an important company, and itâs healthy, and it has great cash flow. It has innovation. Itâs 70% of the market. Itâs the world leader. But it will not be as significant in terms of revenue, proportionality in the future as it is today because cell and gene therapy will outgrow it.
MVE 是我們業務中至關重要的一部分。它是基礎性的業務。它是一家重要的公司,狀況健康,而且現金流非常好。它有創新。它占有70%的市場。它是全球領導者。但就未來的營收占比而言,它不會像今天這麼重要,因為細胞與基因療法的成長會超過它。
Now Mark can comment on those partnerships we have with the other two.
現在 Mark 可以來談談我們與另外兩家的合作夥伴關係。
Mark Sawicki - Senior Vice President, Chief Scientific Officer
Mark Sawicki - Senior Vice President, Chief Scientific Officer
Yeah. So obviously, what weâre doing is focused on building out an ecosystem that supports a cell and gene therapy global environment. And one of the key elements of that strategy is to really define very strong partnerships with leading entities in the space that are complementary to what we do but donât conflict with what we do. And Parexel and Cardinal Health are two very good examples of that.
好的。很明顯,我們正在做的是聚焦於建立一個支持細胞與基因療法全球環境的生態系。而該策略的關鍵要素之一,就是與該領域的領先機構建立非常強而有力的合作夥伴關係:它們能補足我們所做的事情,但不會與我們的業務產生衝突。Parexel 和 Cardinal Health 就是兩個很好的例子。
So Parexel is a large CRO that really focuses on clinical trial design, FDA advisory services and clinical engagement. And then Cardinal Health is obviously order-to-cash management, reimbursement, regulatory support, and then patient and provider support. And so, us working closely with them really allows our mutual client base to have a best-in-class product offering.
Parexel 是一家大型 CRO,主要聚焦於臨床試驗設計、FDA 諮詢服務以及臨床端的互動/參與。而 Cardinal Health 顯然涵蓋從接單到收款(order-to-cash)管理、給付/報銷(reimbursement)、法規支援,以及病患與醫療提供者支援。因此,我們與他們緊密合作,能讓我們共同的客戶群獲得同級最佳(best-in-class)的產品服務組合。
And folks like Cardinal and Parexel have come to us because we are best in class from a supply chain services standpoint. These help drive the industry. So weâre focused on long-term partnerships that help drive standardization and efficiency of the industry over time.
像 Cardinal 和 Parexel 這樣的夥伴會找上我們,是因為從供應鏈服務的角度來看,我們是同級最佳。這些合作有助於推動產業發展。因此,我們聚焦於長期合作夥伴關係,隨時間推進,協助推動產業的標準化與效率提升。
Operator
Operator
(Operator Instructions) [Mac Instock], Stephens.
(接線員指示)[Mac Instock],Stephens。
Mac Instock - Analyst
Mac Instock - Analyst
Maybe just one for me. I think you highlighted on your prepared remarks that a large portion of these therapies are getting approved out of Phase 2 already. And with the FDA officially moving towards, like a default one pivotal trial, how do you anticipate this change impacting approvals and investments over the near term? Thanks.
我這邊可能只有一個問題。我記得你在事先準備的發言中提到,這些療法有很大一部分在第二期(Phase 2)就已經獲得核准。而隨著 FDA 正式朝向「預設採用單一關鍵性試驗(one pivotal trial)」的方向前進,你預期這項變化在短期內會如何影響核准與投資?謝謝。
Jerrell Shelton - Chairman of the Board, President, Chief Executive Officer
Jerrell Shelton - Chairman of the Board, President, Chief Executive Officer
Tom, why donât you take that question?
Tom,你要不要來回答這個問題?
Thomas Heinzen - Vice President of Corporate Development and Investor Relations
Thomas Heinzen - Vice President of Corporate Development and Investor Relations
I was going to let Mark do it.
我本來想讓 Mark 來回答。
All right. Anything thatâs going to streamline the process, Mac, is a good thing. In our view, itâs about more patients getting treated on the commercial side. Commercial revenue is higher than clinical revenue because thereâs typically more addressable patients for a commercial therapy than a clinical trial. But Iâll let Mark comment.
好。Mac,任何能夠簡化流程的事情,在我們看來都是好事。在我們的觀點,重點在於商業端能有更多病患接受治療。商業營收高於臨床營收,因為商業化療法通常可觸及的病患數量會比臨床試驗更多。不過我會讓 Mark 補充說明。
Mark Sawicki - Senior Vice President, Chief Scientific Officer
Mark Sawicki - Senior Vice President, Chief Scientific Officer
Yeah. So obviously, yeah, I mean, if they follow through with a single pivotal and donât require a follow-up, thatâs beneficial to us. If they come back and require additional follow-up, then obviously that may slow things down. But if you combine it with some of the other elements, in particular, the REMS requirement changes, thatâs going to be a huge driver for us because that really allows us to push into the community care setting and our client base.
好的。很明顯,是的,我的意思是,如果他們真的落實單一關鍵性試驗、且不要求後續追蹤,那對我們是有利的。如果他們又回頭要求額外的後續追蹤,那顯然可能會讓進度放慢。但如果把它與其他一些要素結合起來,特別是 REMS 要求的變更,那將會是我們的一個巨大驅動力,因為那確實讓我們能推進到社區照護(community care)的場域以及我們的客戶群。
And if you recall, the vast majority of the addressable patient population is still in the community care setting, and so it provides a significant opportunity for upside on the already existing commercial products as well as the new ones that are coming to market.
而且如果你還記得,可觸及的病患族群絕大多數仍在社區照護場域,因此這為既有的商業化產品以及即將上市的新產品,都提供了顯著的上行機會。
Operator
Operator
David Larsen, BTIG.
David Larsen,BTIG。
David Larsen - Analyst
David Larsen - Analyst
Hi. Congratulations on a good quarter. Can you talk about the MVE or product revenue growth in the fourth quarter? It looks like it was up 2% year over year. For the year, it was up 7% year over year. So it looks like it maybe slowed a little bit in the fourth quarter. Why was that? And what will sort of drive the re-acceleration in growth in 2026?
你好。恭喜本季表現不錯。你能談談第四季 MVE 或產品營收的成長嗎?看起來年增2%。全年則是年增7%。所以看起來第四季可能稍微放緩了一點。為什麼會這樣?以及2026年成長重新加速的動能會來自哪些因素?
Jerrell Shelton - Chairman of the Board, President, Chief Executive Officer
Jerrell Shelton - Chairman of the Board, President, Chief Executive Officer
David, you canât look at MVE systems on a quarterly basis and make too many judgments. So I mean, the decisions for purchase of capital equipment that MVE manufactures as cryogenic systems is planned over a period of time. And many times, itâs highly engineered in terms of the setting that itâs going into the installation and its purpose. So itâs difficult to look at it.
David,你不能用季度的角度去看 MVE systems,然後就下太多判斷。我的意思是,MVE 製造的資本設備(作為低溫系統)的採購決策,是在一段時間內規劃的。而且很多時候,針對其要進入的場域、安裝方式與用途,都需要高度工程化設計。所以很難用季度來看。
Youâre better off to look at an annual growth rate or a moving 12 months if you want to look at it as moving 12 months. But MVE is solid. Itâs a solid company, and the markets seem to be -- we certainly are trying to help stabilize those markets. And thereâs nothing more to add there other than if you have some comments, Robert, but I think thatâs the summary.
你最好看年度成長率,或如果你想用移動12個月(moving 12 months)的方式,就看移動12個月的數據。但 MVE 很穩健。它是一家穩健的公司,而市場看起來也——我們當然正在努力協助穩定那些市場。除此之外沒有更多要補充的;除非你有什麼評論,Robert,但我認為總結就是如此。
Robert Stefanovich - Chief Financial Officer, Senior Vice President, Chief Administrative Officer
Robert Stefanovich - Chief Financial Officer, Senior Vice President, Chief Administrative Officer
Yeah. Just to give you maybe a little bit more granular picture of 2025, when we looked at kind of the market growth and the MVE starting to come back and demand starting to come back, weâve seen that on both sides of the product portfolio, the cryogenic freezers as well as the cryogenic transportation and cryogenic dewar portfolio.
是的。為了讓你對 2025 年有更細緻一些的了解,當我們觀察市場成長、MVE 開始回升以及需求開始回溫時,我們看到這種趨勢同時出現在產品組合的兩端:低溫冷凍櫃,以及低溫運輸與低溫杜瓦瓶(dewar)產品組合。
And then from a regional perspective as well, in the various quarters, weâve seen really all three regions at certain times starting to see a pickup in demand. So certainly, itâs a departure from what weâve experienced in '22, '23. And with that, our guidance does assume some moderate mid-single digit type of growth rates for '26.
從區域角度來看,在不同季度中,我們也確實看到三大區域都在某些時點開始出現需求回升。所以這當然不同於我們在 2022、2023 年所經歷的情況。基於此,我們的指引假設 2026 年會有溫和的中個位數成長率。
Jerrell Shelton - Chairman of the Board, President, Chief Executive Officer
Jerrell Shelton - Chairman of the Board, President, Chief Executive Officer
And David, I want to remind you of one other thing, and this is just a matter of explanation so that youâre aware of it. I mean, MVE furnishes both Cryoport systems and cryogene with products, with cryogenic freezers as well as dewars. The number youâre seeing, the 7% for the year, for example, is a net number. It doesnât include its sales internally. So I just wanted to point that out.
David,我還想提醒你另一件事,這只是說明一下,讓你了解。MVE 同時向 Cryoport Systems 與 Cryogene 供應產品,包括低溫冷凍櫃以及杜瓦瓶。例如你看到的全年 7% 這個數字,是淨額數字。它不包含其內部銷售。所以我只是想指出這一點。
David Larsen - Analyst
David Larsen - Analyst
Okay. Then five years from now, what percentage of total revenue do you think could be coming from commercial?
好的。那麼五年後,你認為總營收中有多少百分比可能會來自商業化(commercial)?
Jerrell Shelton - Chairman of the Board, President, Chief Executive Officer
Jerrell Shelton - Chairman of the Board, President, Chief Executive Officer
Weâll come back and talk with you about that. I canât tell you right offhand right now. I donât have a forecast for that. Thereâs too many uncertainties right now for five years out. Five years is a long time in this business.
我們之後再回來跟你討論這個。我現在沒辦法立刻告訴你。我沒有這方面的預測。對於五年後而言,目前不確定性太多。在這個產業裡,五年是很長的一段時間。
Mark Sawicki - Senior Vice President, Chief Scientific Officer
Mark Sawicki - Senior Vice President, Chief Scientific Officer
Yeah. We do model everything out, right? But as the timeframe goes out, thereâs more uncertainties that creep into the modeling, in particular, around the timing of new product launches and their adoption to the market. Thereâs been products where the consensus from a market standpoint was this would be a very high growth, high traction product, and it disappointed or vice versa. Thereâve been a couple of sleeper surprises where folks didnât anticipate much out of the product, and then it came in a lot stronger than anticipated.
是的。我們確實會把所有事情都建模推演,對吧?但時間拉得越長,模型中就會滲入更多不確定性,尤其是新產品上市時點以及市場採用速度。有些產品在市場共識上原本被認為會是高成長、高滲透的產品,結果表現令人失望;反之亦然。也有幾個「黑馬」驚喜,大家原本不預期產品會有太多表現,結果實際表現遠超預期。
The key here to think about is again, the portfolio effect, right? And so, our focus is around capturing the plurality of the clinical market and then holding it through commercial activity and a commercial launch. So weâre currently supporting 20 commercial products. Youâve seen the positive benefit over the last 12 months of that commercial portfolio, where our commercial revenue has been extremely strong from a growth standpoint. And we have a very strong prognosis on portfolio clients. Weâve already talked about the potential of another nine approvals this year, as well as additional geographic and market expansions.
這裡要思考的關鍵仍然是產品組合效應,對吧?因此,我們的重點在於取得臨床市場的最大份額,並在商業化活動與商業上市後把它守住。我們目前支援 20 個商業化產品。你也看到過去 12 個月這個商業化產品組合帶來的正面效益,我們的商業化營收在成長面表現非常強勁。而且我們對產品組合客戶有非常強的前景判斷。我們也已經談到今年可能再取得另外 9 項核准,以及更多地理區域與市場的擴張。
As you look out further, that continues to expand out. And if youâre looking at the support mechanism of those, of our Phase 2 and Phase 3 programs, a significant percentage of those will have a decision from a regulatory standpoint over the next three to four years, which will really impact those numbers fairly dramatically, assuming that we get a reasonable return on commercial approvals.
再往更遠看,這個趨勢會持續擴大。如果你看我們第二期與第三期計畫的支援機制,其中相當高比例會在未來三到四年內從法規角度做出決策;假設我們在商業化核准上取得合理成果,這將相當劇烈地影響這些數字。
And then you have to also look at, obviously, the impact of the REMS and the community care engagement, which is going to be a huge factor as it relates to what that growth rate looks like. If our partners are successful in driving into the community care setting, and the leader on that is really Janssen CARVYKTI product, where theyâve published data that shows that theyâre in the mid-30s now on a community care engagement standpoint. If they push that up to 50%, 60%, 70% and you have others that are doing the same, thatâs going to have a significant material impact, not only in the existing commercial products but the new ones coming to market.
此外你也必須考量,顯然還有 REMS 與社區照護(community care)導入的影響,這會是決定成長率樣貌的一個巨大因素。如果我們的合作夥伴成功推進到社區照護場景,其中領先者確實是 Janssen 的 CARVYKTI 產品;他們已發布數據顯示,在社區照護導入方面目前已達到 30% 多的水準。如果他們把這個比例推升到 50%、60%、70%,而且其他公司也做同樣的事,這將對現有商業化產品以及即將上市的新產品帶來重大且實質的影響。
Jerrell Shelton - Chairman of the Board, President, Chief Executive Officer
Jerrell Shelton - Chairman of the Board, President, Chief Executive Officer
And David, just a couple of other comments. I mean, while -- to add to what Mark is saying. I think you can undoubtedly say that in the future that cell and gene therapy -- commercial cell and gene therapy revenues will be the dominant factor. Itâll be the dominant factor in our revenue. Itâll be by far, and because it drives not only the BioLogistics. It drives the BioStorage, BioServices.
David,再補充幾點。也就是——在 Mark 所說的基礎上再加一些。我認為你毫無疑問可以說,未來細胞與基因治療——商業化細胞與基因治療的營收——將會是主導因素。它會成為我們營收的主導因素。而且會是遠遠的主導,因為它不僅帶動 BioLogistics,也帶動 BioStorage、BioServices。
You saw in this last quarter, I think it was a quarter, we grew about 23%. What youâre going to see over time is youâre going to see as cell and gene therapy picks up, that is the commercial therapy approvals happen. Youâre going to see our growth rate come more in line with the growth of the industry. Because the lower growth segments, which are foundational to what we do, will be less of a proportion. Itâs an interesting question. I just donât -- we donât have a specific answer, but directionally, we know where weâre going.
你在上一季看到,我想是那一季,我們成長了大約 23%。隨著時間推進,你會看到當細胞與基因治療加速、也就是商業化治療核准發生時,你會看到我們的成長率會更貼近產業的成長。因為那些成長較低、但構成我們業務基礎的區塊,所占比重會變小。這是個很有意思的問題。我只是——我們沒有一個具體答案,但就方向而言,我們知道我們要往哪裡走。
You had something else to add, Mark?
Mark,你還有要補充的嗎?
Mark Sawicki - Senior Vice President, Chief Scientific Officer
Mark Sawicki - Senior Vice President, Chief Scientific Officer
Yeah. I just want to point out, if you go to slide 6 in our presentation deck, thatâll give you some market data that should give you a reasonable understanding of the opportunity associated with our commercial portfolio at this point.
有。我只是想指出,如果你看我們簡報資料的第 6 頁,那裡有一些市場數據,應該能讓你對目前我們商業化產品組合所對應的機會有相當合理的理解。
Operator
Operator
There are no further questions at this time. Iâm going to turn the call back to the management team for closing comments. Please go ahead.
目前沒有其他問題。我將把電話交回管理團隊做結語。請繼續。
Jerrell Shelton - Chairman of the Board, President, Chief Executive Officer
Jerrell Shelton - Chairman of the Board, President, Chief Executive Officer
Okay, one second. I wasnât prepared for that. Okay. Well, thank you for your questions. Very good questions and good discussion, and we appreciate those questions.
好的,等一下。我沒有準備到這個。好。那麼,謝謝各位的提問。問題都非常好,也有很好的討論,我們很感謝這些問題。
So in summary, we made some significant strides in 2025 with solid results showing full-year revenue performance above guidance. Our Life Science Services business segment grew 18% year over year, including 22% increase in BioStorage, BioServices revenue, a 29% increase in revenue from commercial cell and gene therapy we support.
總結來說,我們在 2025 年取得了一些重大進展,穩健的成果顯示全年營收表現高於指引。我們的生命科學服務(Life Science Services)業務部門年增 18%,其中包括 BioStorage、BioServices 營收年增 22%,以及我們所支援的商業化細胞與基因治療帶來的營收年增 29%。
We concluded 2025 supporting a record 760 clinical trials and 20 commercially approved cell and gene therapies worldwide. Of the 760 clinical trials we support, 86 are in Phase 3 and 361 in Phase 2, creating what we believe is a spring-loaded position to future commercial cell and gene therapy revenue streams.
我們在 2025 年結束時,支援的臨床試驗數量創下紀錄,達 760 項,並在全球支援 20 項已獲商業核准的細胞與基因治療。在我們支援的 760 項臨床試驗中,有 86 項處於第三期、361 項處於第二期,形成我們認為可為未來商業化細胞與基因治療營收來源「蓄勢待發」的布局。
In addition to our financial performance, we continue to advance targeted strategic initiatives which are designed to strengthen our growth trajectory in 2026 and beyond. Based on our market position and industry insights, we are encouraged by the opportunities ahead, and we will continue to keep you updated on our progress.
除了財務表現之外,我們也持續推進具針對性的策略性計畫,旨在強化我們在 2026 年及之後的成長軌跡。基於我們的市場地位與產業洞察,我們對前方的機會感到振奮,並將持續向各位更新我們的進展。
Thank you for joining us on todayâs call. We appreciate your continued interest and support. And look forward to speaking with you again when we report our first quarter financial results for 2026. We wish you all a good evening. Operator?
感謝各位參加今天的電話會議。我們感謝各位持續的關注與支持。也期待在我們公布 2026 年第一季財務結果時,再次與各位交流。祝各位晚安。接線員?
Operator
Operator
Ladies and gentlemen, this concludes todayâs conference call. Thank you very much for your participation. You may now disconnect.
各位女士、先生,今天的電話會議到此結束。非常感謝各位的參與。您現在可以掛線。