Caris Life Sciences, Inc. (CAI) 2026 Q3 法說會逐字稿

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  • Operator

    Operator

  • Good afternoon, everyone, and welcome to the Caris Life Sciences' third-quarter 2026 earnings call. My name is Lisa, and I will be your conference operator today. (Operator Instructions) After the prepared remarks, there will be a question-and-answer session. As a reminder, this call is being recorded.

    各位下午好,歡迎參加 Caris Life Sciences 2026 年第三季財報電話會議。我叫 Lisa,今天將擔任會議接線員。(接線員指示) 在管理層的準備發言之後,將進行問答環節。提醒各位,本次電話會議將被錄音。

  • I would now like to hand it over to Russ Denton at Caris. Please go ahead.

    現在我想把電話交給 Caris 的 Russ Denton。請開始。

  • Russ Denton - Senior Vice President, General Counsel, Secretary

    Russ Denton - Senior Vice President, General Counsel, Secretary

  • Thank you. Earlier today, Caris Life Sciences released financial results for the quarter ended September 30, 2026. Joining from Caris today are David Dean Halbert, our Founder, Chairman and CEO; and David Spetzler, our President; Brian Brille, our Vice Chairman and EVP; and Luke Power, our CFO.

    謝謝。今天稍早,Caris Life Sciences 公布了截至 2026 年 9 月 30 日止季度的財務業績。今天與會的 Caris 團隊成員包括:我們的創辦人、董事長兼執行長 David Dean Halbert;總裁 David Spetzler;副董事長兼執行副總裁 Brian Brille;以及財務長 Luke Power。

  • Before we begin, I'd like to remind you that during this call, management will make forward-looking statements within the meaning of federal securities laws. These statements are based on management's current expectations and involve risks and uncertainties that could cause actual results to materially differ from those anticipated.

    在開始之前,我想提醒各位,在本次電話會議中,管理層將在聯邦證券法的意義下發表前瞻性陳述。這些陳述係基於管理層目前的預期,並涉及風險與不確定性,可能導致實際結果與預期存在重大差異。

  • For a discussion of the factors that could affect our future results, please refer to our SEC filings. We undertake no obligation to update these statements except as required by law. This call will also include a discussion of non-GAAP financial measures, which are adjusted to exclude certain specified items. The reconciliations of these non-GAAP measures to the most directly comparable GAAP measures are provided in today's earnings release. A copy of that today's presentation materials can be found on our Investor Relations website.

    關於可能影響我們未來業績之因素的討論,請參閱我們向 SEC 提交的文件。除法律要求外,我們不承擔更新這些陳述的任何義務。本次電話會議亦將討論非 GAAP 財務衡量指標,該等指標經調整以排除某些特定項目。這些非 GAAP 指標與最直接可比的 GAAP 指標之調節表,已載於今日的財報新聞稿中。今日簡報資料的副本可於我們的投資人關係網站查閱。

  • I'll now turn the call over to our Founder, Chairman and CEO, David Dean Halbert. David?

    接下來我把電話交給我們的創辦人、董事長兼執行長 David Dean Halbert。David?

  • David Halbert - Chairman, Founder, Chief Executive Officer

    David Halbert - Chairman, Founder, Chief Executive Officer

  • Thanks, Russ, and thanks, everyone, for joining. This was another record quarter for us with volume up 21% to 61,500 cases, and our revenue grew 27% to $275 million. What I was about these numbers is that they are the continued result of a plan. At the start of the year, we've realigned and expanded the sales organization and invested in lab ahead of the demand we expected.

    謝謝你,Russ,也謝謝各位參與。本季我們再創紀錄,檢測量成長 21% 至 61,500 例,營收成長 27% 至 2.75 億美元。我對這些數字的看法是:它們是計畫持續落實的結果。年初我們重新調整並擴編銷售組織,並在預期需求到來之前就先行投資實驗室產能。

  • Since then, we have delivered two consecutive quarters of acceleration and this quarter's year-over-year volume growth is the strongest we busted in over a year, and we expect that trend to continue into the fourth quarter. We have also taken the same approach with the product pipeline, where we have launched four products so far this year, and by year-end, we'll launch our fit, Carson, our whole genome MRD assay and complete our comprehensive approach across the patient journey.

    自那之後,我們已連續兩季交出加速成長的表現,而本季的年增檢測量成長是我們一年多以來最強的一次,我們預期這個趨勢將延續到第四季。我們在產品管線上也採取同樣的做法:今年迄今已推出四項產品,並且在年底前,我們將推出我們的 fit、Carson、我們的全基因組 MRD 檢測,並完成涵蓋病患全旅程的全面性布局。

  • And comprehensive isn't just a slogan for us. And you can see that as recently as September, where we launched a new version of Caraher, for therapy selection that reads the therapy relevant genes at 40,000 ex-debt. It takes our RNA reads at $600 million.

    而「全面性」對我們而言不只是口號。你可以在最近的 9 月看到這點:我們推出了新版的 Caraher,用於治療選擇,可在 40,000 ex-debt 的深度讀取與治療相關基因。它讓我們的 RNA 讀取量達到 6 億美元。

  • We always say deeper, not cheaper as the depth and breadth of an assay is what matters, allowing us to continue to drive the sites forward. I made the decision to take the company to whole exome whole transcriptome back in 2018, and that has produced our exome platform, which includes my cancer Seq, Caris Assure for therapy selection and now Caris Assure for monitoring. We're taking the same approach for our next phase with expanding to whole genome, and you can see this in our approach for early-stage detection, therapy selection and MRD.

    我們一直說「更深,而不是更便宜」,因為檢測的深度與廣度才是關鍵,讓我們能持續推動臨床端向前。我在 2018 年決定讓公司走向全外顯子、全轉錄體,這也催生了我們的外顯子平台,其中包括 MI cancer Seq、用於治療選擇的 Caris Assure,以及現在用於監測的 Caris Assure。在下一階段我們也採取同樣策略,擴展到全基因組;你可以在我們對早期偵測、治療選擇與 MRD 的布局中看到這一點。

  • Now with regards to Caris Detect, I told you in August that the interest has run ahead of even my own expectations, and it has, but we're not going to chase it by overspending. We're building this deliberately. We've launched two national campaigns with Kevin Costner and Jordan Spieth, both of whom I've had the pleasure of sitting down with to discuss their reasons for participating in our ads. And we will continue to roll out and expand these into new markets in Q4 and beyond.

    關於 Caris Detect,我在 8 月曾提到市場興趣甚至超出我自己的預期,而確實如此,但我們不會透過過度花費來追逐它。我們會有計畫、循序漸進地建置。我們已與 Kevin Costner 和 Jordan Spieth 推出兩個全國性行銷活動;我也很榮幸能與他們兩位坐下來交流,了解他們參與我們廣告的原因。我們將在第四季及之後持續推出並擴展到新的市場。

  • Also, our next campaign will be focused on educating the public regarding performance and understanding of stage. The whole idea behind early detection is to catch the cancer role is still treatable before it spreads, meaning early Stage 1 and 2. After that, it's likely not to be treatable. This being marketed currently use a technology called methylation. And a methylated only approach doesn't work at early stages for most cancers, and it's unclear why someone would worm, like a pop test for lung cancer when you could take a blood test for over 50 different cancers.

    此外,我們下一個行銷活動將聚焦於教育大眾,讓大家了解檢測表現以及對分期的理解。早期偵測的核心概念,是在癌症仍可治療、尚未擴散之前就把它找出來,也就是第一期與第二期的早期癌症。在那之後,很可能就不再可治療。目前市面上正在行銷的產品使用一種稱為甲基化(methylation)的技術。而僅靠甲基化的方法,對多數癌症在早期階段並不起作用;也不清楚為什麼有人會想要做像是針對肺癌的抹片檢查,當你其實可以透過抽血檢測超過 50 種不同癌症。

  • That's exactly why we built Caris Detect whole genome is designed to find cancer at those early treatable stages. We'll keep building it that way. And as David will discuss in a few minutes, we are also going to continue to demonstrate our best-in-class performance by expanding our Achieve program. So I feel great about where we are. We went deeper when others were cheaper. We built a plan that is working, and we're funding every bit of it ourselves while we manage the P&L.

    這正是我們打造 Caris Detect 的原因:全基因組的設計就是要在那些可治療的早期階段找出癌症。我們會持續以這樣的方式建置。而如同 David 幾分鐘後將會說明的,我們也會透過擴大 Achieve 計畫,持續證明我們同級最佳的表現。因此我對我們目前的進展感到非常有信心。當別人選擇更便宜時,我們選擇做得更深。我們建立了一個正在奏效的計畫,並在管理損益表的同時,完全以自有資金為每一項投入提供資金。

  • We'll keep making decisions the way we always have by the module. If it were my mom, I want her to get the complete answer possible. Every patient deserves that. And that's how we'll make precision medicine a reality. Brian, over to you.

    我們會一如既往,依照模組來做決策。如果是我媽媽,我希望她能得到盡可能完整的答案。每一位病患都值得如此。而這就是我們讓精準醫療成為現實的方式。Brian,交給你。

  • Brian Brille - Vice Chairman of the Board, Executive Vice President

    Brian Brille - Vice Chairman of the Board, Executive Vice President

  • Thanks, David, and thank you all for joining our third-quarter 2026 earnings call. This is another record quarter and an extremely important quarter for Caris.

    謝謝你,David,也謝謝各位參加我們 2026 年第三季財報電話會議。這又是一個創紀錄的季度,也是對 Caris 極其重要的一季。

  • First, the commercial strategy and investment is working and is delivering accelerating volume growth. In addition, the MSAD launch is advancing well with important new potential channel partners who are excited about Caris Detect's technology and specifically early-stage sensitivity.

    首先,我們的商業策略與投資正在發揮效果,並帶來加速的檢測量成長。此外,MSAD 的上市推進順利,並出現了重要的新潛在通路合作夥伴,他們對 Caris Detect 的技術、尤其是早期分期的靈敏度感到振奮。

  • We're also announcing our entry into the MRD and monitoring market with the launch this quarter of Caris Assure therapy response monitoring. This will be followed by the upcoming launch in December of Caris Confirm for MRD. And with the launch of these products, we now have the best molecular technology across the entire cancer care continuum. And we did all of this while delivering sustained growth and profitability.

    我們也宣布進入 MRD 與監測市場:本季推出 Caris Assure 治療反應監測。接著在 12 月將推出用於 MRD 的 Caris Confirm。隨著這些產品的推出,我們現在在整個癌症照護連續體上都具備最佳的分子技術。而我們在做到這一切的同時,也交出了持續的成長與獲利能力。

  • Our commercial strategy and investment program is successful in delivering results. In the third quarter, we completed approximately 61,500 clinical cases, up 21% year over year. This is our second consecutive quarter of accelerating growth, up from 15% in the first quarter and 18% in the second quarter. And we expect the momentum to continue as the commercial platform expands and new members of the sales force season.

    我們的商業策略與投資計畫成功帶來成果。第三季我們完成約 61,500 例臨床個案,年增 21%。這是我們連續第二季呈現加速成長,從第一季的 15% 提升到第二季的 18%。隨著商業平台擴張以及新加入的銷售人員逐步成熟,我們預期這股動能將持續。

  • With respect to the pipeline, Caris Detect launched this summer and Caris Assure therapy monitoring launch this quarter. As a result, as illustrated on slide 4, our platform now spans the entire continuum of care, including therapy selection in tissue and liquid biopsy with MI cancer seek and Caris Assure, respectively. Therapy selection in hematological cancers with Comasec. Caris Detect for MSD, Caris Assure for monitoring and Caris Confirm for MRD.

    就產品管線而言,Caris Detect 已於今年夏季上市,而 Caris Assure 治療監測也於本季推出。因此,如投影片 4 所示,我們的平台如今已涵蓋整個照護連續體,包括:分別透過 MI cancer seek 與 Caris Assure,在組織與液體切片中進行治療選擇。在血液腫瘤中透過 Comasec 進行治療選擇。Caris Detect 用於 MSD,Caris Assure 用於監測,以及 Caris Confirm 用於 MRD。

  • We're very excited about the initial assay in our MRD product suite, Caris Assure for monitoring. Monitoring is highly important clinically to provide oncologists a quantitative measure of treatment efficacy. The elegance of our technology is that it utilizes the same product platform as cares assure liquid biopsy with the same whole exome 23,000 gene platform, and the same liquid workflow our customers already use the therapy selection.

    我們對於我們 MRD 產品組合中用於監測的初始檢測項目 Caris Assure 感到非常振奮。在臨床上,監測極其重要,能為腫瘤科醫師提供治療療效的量化衡量指標。我們技術的精妙之處在於,它使用與 Caris Assure 液體活檢相同的產品平台、相同的全外顯子 23,000 基因平台,以及客戶在治療選擇上已經使用的相同液體檢測工作流程。

  • The serial blood draws using Assure provide us with a consistent longitudinal view of cancer progression during treatment and will add another valuable edge to our clinical genomic data set. Caris Confirm, our tumor-informed whole genome approach to is on track to launch this December. Our clinical customers are excited about the launch of both of these products across the continuum of care. We get significant leverage from our commercial channels since each of these MRD products will be provided to the same institutions, the same oncologists and the same patients that use us for therapy selection.

    使用 Assure 進行連續採血,讓我們能在治療期間對癌症進展取得一致的縱向觀察,並為我們的臨床基因體資料集再增添一項寶貴優勢。Caris Confirm——我們以腫瘤知情(tumor-informed)的全基因組方法——正按計畫於今年 12 月推出。我們的臨床客戶對這兩項產品在整個照護連續體中的上市都感到興奮。由於這些 MRD 產品將提供給與我們進行治療選擇相同的機構、相同的腫瘤科醫師以及相同的病患,我們能從既有商業通路中取得顯著槓桿效益。

  • Finally, our MSET platform, Caris Detect has been the vision of our founder for many years, and the recent launch of Detect continues to build momentum. The unique multi-omic approach of Detect has produced exceptional early stage sensitivity and is being well received by the market. The channel partner conversations from digital platforms to Coal Sears medicine groups are going extremely well.

    最後,我們的 MSET 平台 Caris Detect 多年來一直是我們創辦人的願景,而 Detect 的近期上市持續累積動能。Detect 獨特的多體學(multi-omic)方法在早期癌症靈敏度方面展現卓越表現,並獲得市場良好回響。從數位平台到 Coal Sears 醫療集團的通路夥伴洽談進展非常順利。

  • We launched our first consumer campaign in the third quarter, featuring Heavy Costner and our second recently with Jordan Speed to raise the awareness of the importance of early-stage cancer detection and Caris Detect. We're excited about our data and studies, and special outline that, including the expanded Achieve program.

    我們在第三季推出首個消費者行銷活動,由 Heavy Costner 代言;近期也與 Jordan Speed 推出第二波活動,以提升大眾對早期癌症偵測重要性以及 Caris Detect 的認知。我們對自身的數據與研究感到振奮,並特別概述了相關內容,包括擴大的 Achieve 計畫。

  • Our philosophy continues to be a long-term strategic orientation to develop the best, most comprehensive offerings on the market and to pursue that innovation while maintaining financial strength. We had a strong third quarter with total revenues increasing 27% year over year to $275 million.

    我們的理念仍是以長期策略導向,打造市場上最佳、最全面的產品供給,並在維持財務穩健的同時追求創新。我們第三季表現強勁,總營收年增 27% 至 2.75 億美元。

  • As illustrated on slide 5, this is driven by molecular profiling services revenues of $262.7 million, also up 27%. I'd point out that the prior year quarter also included a significant amount of true-ups, and as a result, on a pro forma basis, revenue grew approximately 45% year over year.

    如投影片 5 所示,成長主要由分子剖析服務營收 2.627 億美元所帶動,同樣年增 27%。我想指出,去年同期也包含相當可觀的追溯調整(true-ups),因此以擬制(pro forma)基礎計算,營收年增約 45%。

  • So in summary, we had a very productive quarter illustrated by the quarter highlights on slide 6. We Strong revenue performance, combined with the operating leverage in our model continued to produce positive financial results while we step up investment, including revenue growth of 27% and driven by clinical volume growth of 21% and a blended ASP of $4,272, up 5% year over year.

    總結而言,我們本季非常有成效,投影片 6 的季度重點已加以說明。我們強勁的營收表現,加上模型中的營運槓桿,即使我們提高投資,仍持續帶來正向財務成果;其中營收成長 27%,主要由臨床量(clinical volume)成長 21% 所驅動,混合 ASP 為 4,272 美元,年增 5%。

  • On a true-up basis, our blended ASP was approximately $4,000 and up 19%. We invested significantly this quarter while maintaining financial discipline. Adjusted EBITDA was $44.4 million, our sixth consecutive quarter of positive adjusted EBITDA, and we returned to GAAP profitability with net income of $15.3 million.

    若以追溯調整(true-up)基礎計算,我們的混合 ASP 約為 4,000 美元,並年增 19%。我們本季在維持財務紀律的同時進行了顯著投資。調整後 EBITDA 為 4,440 萬美元,為連續第六季調整後 EBITDA 為正;同時我們也回到 GAAP 獲利,淨利為 1,530 萬美元。

  • Year-to-date, adjusted EBITDA was $126.3 million. Our balance sheet remains strong with cash and investments of $769 million at quarter end. We believe our financial performance continues to give us unique strategic flexibility, which supports our ongoing investments in the product pipeline as well as the continued expansion of our sales organization.

    年初至今,調整後 EBITDA 為 1.263 億美元。我們的資產負債表仍然強勁,季末現金與投資合計 7.69 億美元。我們認為,我們的財務表現持續賦予我們獨特的策略彈性,支持我們對產品管線的持續投資,以及銷售組織的持續擴張。

  • So with that, let's turn to commercial performance. The commercial strategy and leadership we established in the first quarter is delivering systematically. As slide 7 indicates clinical case volume has grown every quarter this year from approximately 52,800 cases in the first quarter, to 59,200 in the second to approximately 61,500 in the third, and year-over-year growth has accelerated each quarter this year from 15% to 18% to 21%, respectively, and we're pleased with acceleration in growth in both tissue and blood.

    接下來我們轉到商業表現。我們在第一季建立的商業策略與領導團隊正以系統化方式交付成果。如投影片 7 所示,今年臨床案件量每季都在成長:第一季約 52,800 例、第二季 59,200 例、第三季約 61,500 例;而年增率也在今年每季加速,分別為 15%、18%、21%。我們對組織與血液兩條線的成長加速感到滿意。

  • The commercial strategy is working, and we expect to see ongoing growth acceleration for a variety of reasons. First, the therapy selection market remains rich with opportunity as cancer centers implement systematic precision medicine programs. The institution and the individual medical oncologists greatly appreciate the breadth and depth of the Caris product technology, i.e., 23,000 genes. And we expect that our recent launch of monitoring and upcoming launch of MRD will greatly enhance both our volume performance and also our appeal as a strategic partner with a technologically superior product line across the care continuum.

    商業策略正在奏效,我們預期基於多項原因,成長加速將持續。首先,隨著癌症中心導入系統化精準醫療計畫,治療選擇市場仍充滿機會。機構端與個別腫瘤內科醫師都高度肯定 Caris 產品技術的廣度與深度,也就是 23,000 個基因。我們預期近期推出的監測產品與即將推出的 MRD,將大幅提升我們的量能表現,也會強化我們作為策略夥伴的吸引力——在整個照護連續體提供技術更優越的產品線。

  • Finally, we accept strong cancer center relationships and the investment in FTEs will continue to help us activate more medical oncologists across our broad new product line. With respect to the commercial team investments we ended the third quarter with 325 commercial team members, up from 290 at the end of the second quarter and 270 at the end of the first. We completed the realignment in January, expanding from 82 to 146 territories, and we've continued to add reps against that structure. Typically, new reps take six to nine months to begin to reach full productivity. So the hires we made through this year will continue to build towards their full contribution for some time.

    最後,我們既有的強健癌症中心關係,以及對全職人力(FTE)的投資,將持續協助我們在廣泛的新產品線上啟動更多腫瘤內科醫師的採用。就商業團隊投資而言,我們在第三季末共有 325 名商業團隊成員,高於第二季末的 290 名與第一季末的 270 名。我們在 1 月完成重整,將區域從 82 個擴增至 146 個,並持續依此架構增聘業務代表。一般而言,新進代表需要 6 到 9 個月才能開始達到完全生產力。因此,我們今年所招募的人員仍將在一段時間內持續累積至其完整貢獻。

  • We believe that we have the best technology platform, and accordingly, we intend to continue this commercial investment plan to provide this broad product line to as many medical oncologists and institutions as possible. Digital footprint continues to expand as well. More than 75% of orders are placed through EMR and portal channels with more than 3,500 physicians ordering directly through the EMR. We're making investments in research and studies and our body of evidence now exceeds 1,300 publications and manuscripts.

    我們相信我們擁有最佳的技術平台,因此我們打算持續推進此商業投資計畫,將這條廣泛的產品線提供給盡可能多的腫瘤內科醫師與機構。我們的數位觸及也持續擴大。超過 75% 的訂單透過 EMR 與入口網站(portal)通路下單,且有超過 3,500 位醫師直接透過 EMR 下單。我們也持續投資研究與試驗,目前我們的證據體系已超過 1,300 篇發表與手稿。

  • Our business model is very powerful. With every clinical case profile, our data set grows in size and power. As slide 8 indicates, our data set has surpassed 1.2 million profiled cases, including more than 796,000 whole exomes, 849,000 transcriptomes, with approximately 845,000 matched cases with clinical outcomes. We are currently evaluating AI partners with respect to both internal capabilities, as well as external data partnerships. We are as excited about the prospects ahead of us as we have ever been.

    我們的商業模式非常強大。每完成一個臨床病例剖析,我們的資料集就會在規模與效力上持續成長。如投影片 8 所示,我們的資料集已超過 120 萬個完成剖析的病例,其中包含超過 796,000 個全外顯子、849,000 個轉錄體,並約有 845,000 個與臨床結局相匹配的病例。我們目前正在評估 AI 合作夥伴,涵蓋內部能力以及外部資料合作。我們對未來前景的期待,與以往任何時候一樣高。

  • As illustrated on slide 9, our company's positioning is highly differentiated against huge market opportunities and demand. The Caris molecular technology features uniquely powerful breadth and depth, which is now being extended to new product modalities. We have an innovative go-to-market approach as both a clinical partner and a research partner. The Caris Precision Oncology Alliance, for example, is now up to 102 sites. And we have important strategic flexibility given our profitability, which will enable us to continue to invest aggressively.

    如投影片 9 所示,我們公司的市場定位在龐大的市場機會與需求面前具高度差異化。Caris 的分子技術具備獨特且強大的廣度與深度,並正延伸至新的產品形式。我們以臨床合作夥伴與研究合作夥伴的雙重角色,採取創新的市場進入(go-to-market)方式。例如,Caris 精準腫瘤聯盟(Caris Precision Oncology Alliance)目前已擴展至 102 個據點。此外,基於我們的獲利能力,我們具備重要的策略彈性,將使我們能持續積極投資。

  • We have exciting and significant analysts ahead of us over the next few quarters, which offer growth and TAM expansion. Ongoing commercial execution and investment, ASP expansion through Assure, a pioneering role in the MSD market, the recent launch of monitoring and the upcoming launch of MRD.

    未來幾季我們將迎來多項令人振奮且重要的催化劑,帶來成長與 TAM 擴張。包括持續的商業執行與投資、透過 Assure 推動 ASP 擴張、在 MSD 市場的先驅角色、近期推出的監測產品,以及即將推出的 MRD。

  • I'll now turn the presentation over to Dr. Spetzler. Spetz?

    接下來我把簡報交給 Spetzler 醫師。Spetz?

  • David Spetzler - President, Chief Scientific Officer

    David Spetzler - President, Chief Scientific Officer

  • Thanks, Brian. I will walk through the two new products and then the foundation model behind our digital AI platform. our planned expansion of our achieved program for Caris Detect and will close on interception. Everything I'm about to talk through comes back to what Dave said at the open, deeper, not cheaper. Depth and breadth are what allows us to complete a comprehensive approach across the patient journey from early stage detection to therapy selection and now monitoring and MRD.

    謝謝,Brian。我將說明兩項新產品,以及我們數位 AI 平台背後的基礎模型。也會談到我們針對 Caris Detect 的 Achieve 計畫之規劃擴張,最後以 interception 作結。我接下來要談的所有內容,都回到 Dave 在開場時所說的:更深,而不是更便宜。正是深度與廣度,讓我們能在病患旅程中完成一套全面的方法——從早期偵測到治療選擇,現在再到監測與 MRD。

  • Slide 11 frames the 2 launches of the fourth quarter together. Caris Assure therapy response monitoring, which launched recently, covers the patient on therapy. Caris Confirm launching in December, covers surveillance after treatment. Both are built on platforms we already run. Monitoring sits on our whole exome platform.

    第11張投影片將第四季的兩項產品上市一併呈現。近期推出的 Caris Assure 治療反應監測,涵蓋治療中的病患。預計於12月推出的 Caris Confirm,涵蓋治療後的追蹤監測。兩者皆建立在我們既有運行的平台之上。監測方案建置於我們的全外顯子體平台。

  • Caris Confirm sits on our whole genome platform with the initial tissue sample to define the signature then follow-up testing and blood.

    Caris Confirm 建置於我們的全基因組平台上,先以初始組織樣本定義特徵簽名,之後進行追蹤檢測與血液檢測。

  • Each has its own evidence base Monsta and our real-world cohort for monitoring, Ensemble and the real-world cohort for Caris Confirm. Reimbursement work is underway on both a MolDX submission and preparation for moundering and a cancer type by cancer type strategy for Caris Confirm, and I will discuss each of titlmore.

    兩者各自有其證據基礎:監測使用 Monsta 與我們的真實世界隊列;Caris Confirm 使用 Ensemble 與真實世界隊列。兩者的給付(reimbursement)工作都在進行中:包括 MolDX 送件,以及為 Caris Confirm 進行準備(moundering)並採取按癌種逐一推進的策略;我將更詳細地逐一說明。

  • Let's start with Caris Assure therapy response monitoring, which launched recently as part of the upgraded Caris Assure platform. For therapy selection, Caris Assure tells the oncologists which drug to choose for monitoring the same whole exome liquid workflow with matched Buffet code to remove clonal hematopoiesis gives a quantitative tumor fraction and serial draws classify the patient as a molecular response, stability or progression. The readout arrives roughly four to eight ahead of the scheduled scan. The validation is on the slide.

    先從 Caris Assure 治療反應監測開始;它近期已作為升級版 Caris Assure 平台的一部分推出。在治療選擇方面,Caris Assure 會告訴腫瘤科醫師該選擇哪一種藥物;在監測方面,採用相同的全外顯子體液體檢測流程,搭配配對的 Buffet code 以去除克隆性造血(clonal hematopoiesis),可得到定量的腫瘤比例(tumor fraction),並透過連續採血將病患分類為分子反應、穩定或進展。讀出結果大約會比預定影像掃描早四到八週出來。驗證結果在投影片上。

  • Clinical validation included 124 serial pairs and in the 90-patient landmark cohort, 96% of patients classified as molecular responders went on to show disease control on imaging, 49 out of 51. Patients classified as molecular progression had a hazard of subsequent radiographic progression nearly 9x higher than responders, 8.99 or 7.16 after statistical adjustments.

    臨床驗證包含124對連續配對樣本;在90位病患的里程碑(landmark)隊列中,被分類為分子反應者的病患有96%在影像上後續呈現疾病控制(49/51)。被分類為分子進展的病患,其後續影像學進展的風險(hazard)幾乎是反應者的9倍,未調整為8.99,統計調整後為7.16。

  • And in an early independent real-world cohort of 1,037 patients, molecular progression carries a 2.35x hazard versus response with the three categories separating in order. Analytically, the assay detects tumor fractions down to 0.1% with Precision under 9% CV across lots and runs.

    在一個早期、獨立的真實世界隊列(1,037位病患)中,分子進展相較於分子反應的風險比為2.35倍,且三個分類呈現依序分離。在分析效能方面,本檢測可偵測低至0.1%的腫瘤比例,且跨批次與跨跑次的精密度(Precision)CV低於9%。

  • Moving to slide 13. Caris Confirm is our entry into minimal residual disease and is currently planned for launch in December. The approach is tumor informed and whole genome. We sequence the tumor and a matched normal across the entire genome to find a patient set of trackers.

    接著看第13張投影片。Caris Confirm 是我們切入微量殘存病灶(minimal residual disease, MRD)的產品,目前規劃於12月推出。其方法為腫瘤知情(tumor-informed)且採全基因組。我們會對腫瘤與配對正常樣本進行全基因組定序,以找出病患專屬的一組追蹤標記(trackers)。

  • A track research base of roughly 2.5 billion bases. We then track those variants in serial blood draws on the same whole genome platform that powers Caris Detect. The pathway is relatively simple. A baseline blood draw with bucket code plus tumor tissue from surgery, tumor normal subtraction to define the patient's tracker set, a landmark blood draw three to six weeks after surgery and then surveillance straws every three to four months.

    追蹤的研究基礎約為25億個鹼基。接著在同一個為 Caris Detect 提供動力的全基因組平台上,於連續的血液採樣中追蹤這些變異。流程相對簡單。先進行一次基線採血(含 bucket code),並取得手術的腫瘤組織;透過腫瘤/正常扣除(tumor normal subtraction)定義病患的追蹤標記集合;在術後三到六週進行一次里程碑採血,之後每三到四個月進行一次監測採血。

  • That is what gives us an ultra-low limit of detection by design. The analytic performance speaks for itself with a minimum positivity threshold of 1.38 parts per million, the intended use is pan tumor Stage 1 through 3 solid tumors for curative intent treatment, a setting where patients are monitored for years. So like therapy monitoring, this is a reoccurring test on infrastructure that is already in place.

    這樣的設計使我們能在原理上達到超低的偵測極限(ultra-low limit of detection)。分析效能不言自明:最低陽性閾值為每百萬分之1.38(1.38 parts per million)。其預期用途為泛腫瘤(pan-tumor)的第1至第3期實體腫瘤、以根治意圖治療的情境;在此情境下,病患通常需被監測多年。因此,如同治療監測一樣,這是一項建立在既有基礎設施上的重複性檢測。

  • Moving to slide 14. This is our engine under our digital AI platform. HERO is our pathology foundation model. It was trained on 248,606 routine -- he lives across 52 cancer lineages and 98% of those slides more than 243,000 also have RNA sequencing alongside DNA sequencing and IHCs. That pairing is the asset. The molecular results give us every slide is labels. The process runs left to right on the slide, the H&E is scanned at 20x. The tissue is cut into tiles about 10th of the millimeter across roughly 2,300 per slide.

    接著看第14張投影片。這是我們數位 AI 平台底層的引擎。HERO 是我們的病理基礎模型(pathology foundation model)。它以248,606張常規切片進行訓練——涵蓋52個癌症譜系;其中98%的切片(超過243,000張)同時具備 RNA 定序、DNA 定序與 IHC。這種配對是關鍵資產。分子結果讓我們能為每張切片提供標籤。流程在投影片上由左至右進行:H&E 以20倍掃描。組織被切分成約十分之一毫米大小的 tiles,每張切片約2,300個。

  • HERO each time as 3,072 separate numbers, the same for every target with no retraining. For each target, the model learns how much each town matters and waves the tiles into one summary of the slide. And from that, three models, one for each of DNA, RNA and IHC predict 297 alterations, 368 RNA expression levels and 21 protein stains from the same slide alone.

    HERO 每次會輸出3,072個獨立數值;對每個目標皆相同,無需重新訓練。針對每個目標,模型會學習每個 tile 的重要性,並將所有 tiles 彙整成該切片的一個摘要表示。在此基礎上,三個模型(分別對應 DNA、RNA 與 IHC)僅憑同一張切片即可預測297項變異、368個 RNA 表現量,以及21種蛋白染色結果。

  • Our model Powers Caris digital AI applications, that is why the pipeline on the right, morphological subtype, tumor rating, mutation prediction, treatment response and survival prediction can move quickly. Each is a new head on the same foundation trained on data we already have.

    我們的模型驅動 Caris 的數位 AI 應用;這也是為什麼右側的流程——形態學亞型、腫瘤分級、突變預測、治療反應與存活預測——能夠快速推進。每一項都是建立在同一個基礎模型之上的新輸出頭(new head),而該基礎模型是用我們既有的資料訓練而成。

  • Now let me turn to Caris Detect. As we have discussed before, slide 16 shows why we built Caris Detect to combine many signals across cell-free DNA and RNA, expanding our shops across goals expanding our shots on goal across each early tumor.

    接下來我談 Caris Detect。如同我們先前討論過的,第16張投影片說明了我們為何打造 Caris Detect:將游離 DNA 與 RNA 的多種信號加以整合,擴大我們的覆蓋範圍,並在每一種早期腫瘤上增加命中機會。

  • Moving to slide 17. Achieve 1, the basis for our commercial launch showed 99.2% specificity and 60.3% sensitivity in Stage 1 and Stage 2 cancers, the stages where the cure rate is highest, and I will give an update on our plan to next readout from Achieve 2 in a few moments.

    接著看第17張投影片。Achieve 1 作為我們商業化上市的基礎,顯示特異性(specificity)為99.2%,在第1期與第2期癌症的敏感性(sensitivity)為60.3%;而這些分期正是治癒率最高的階段。我稍後也會更新 Achieve 2 下一次讀出的規劃。

  • Now as part of this quarterly update, I will provide an update on our Achieve program. As you know, this is the clinical evidence program behind Caris Detect and one that we are announcing an expansion to with four studies under the achieved name totaling 63,000 patients. Achieve 1 is the 3,000-patient study you just saw. That readout was delivered in the first quarter. Achieve 2 is our large-scale validation with a target of 25,000 participants. We have rolled approximately 20,000 patients 80% of the way there, and we certainly expect an interim readout in Q1 2027 as we have begun to run these samples.

    在本次季度更新中,我也將更新我們的 Achieve 計畫。如各位所知,這是支撐 Caris Detect 的臨床證據計畫;我們也宣布將其擴大,在 Achieve 名稱下共有四項研究,合計63,000名病患。Achieve 1 是你們剛看到的3,000人研究。該讀出已於第一季公布。Achieve 2 是我們的大規模驗證研究,目標招募25,000名參與者。我們已納入約20,000名病患,完成度達80%;且由於我們已開始跑這些樣本,我們確實預期在2027年第一季取得一次期中讀出(interim readout)。

  • Achieve 3 is a 10,000-patient prospective study in a high-risk population with results returned to patients and a repeat cars defect at 12 months and achieve 4 is a 25,000 patient prospective study in a general risk population, also with results returned. Achieve 3 and 4 are in planning now.

    Achieve 3 是一項在高風險族群進行的10,000人前瞻性研究,結果會回傳給病患,並在12個月時重複進行一次 Caris Detect;Achieve 4 則是一項在一般風險族群進行的25,000人前瞻性研究,同樣會回傳結果。Achieve 3 與 4 目前正在規劃中。

  • And on slide 19, as DDH discussed, we have launched two campaigns for Caris Detect, and both point consumers to care detect, and these will continue to be rolled out across markets into Q4 and beyond.

    在第19張投影片,如 DDH 所述,我們已為 Caris Detect 啟動兩個行銷活動,兩者都會將消費者導向 Care Detect;且這些活動將持續在各市場推進至第四季及之後。

  • Finally, personalized mutation interception, we outlined this program on our last call. So today, I will keep it brief and focus on how the pieces of our platform fit together to support it. As a reminder, our personalized vaccine approach is built on capabilities we already run. Caris Detect finds the early signal, are sequencing defines the mutations that inform a personalized vaccine and serial blood draws track whether it is clearing.

    最後是個人化突變攔截(personalized mutation interception);我們在上一次電話會議已概述此計畫。因此今天我會簡要帶過,聚焦於我們的平台各組件如何相互配合以支援該計畫。提醒一下,我們的個人化疫苗策略建立在我們既有運行的能力之上。Caris Detect 找到早期訊號;我們的定序界定可用於個人化疫苗設計的突變;並透過連續採血追蹤其是否被清除。

  • Slide 21 shows the step where our platform is able differentiate, choosing the right mutation. We select only the mutations that are expressed and visible to the immune system has seen targets, and tracked response over time. This is where our data set does the work. Our ranking model achieves 83.8% positive protected value and 86.5% of the top-ranked variant per patient, measured against a paired biopsy cohort of more than 42,000 patients.

    第21張投影片顯示我們平台能夠做出區分的步驟:選擇正確的突變。我們只挑選那些有表達、且能被免疫系統看見的突變作為目標,並隨時間追蹤反應。這正是我們資料集發揮作用之處。我們的排序模型達到83.8%的陽性預測值(positive predictive value),且在每位病患的最高排名變異上達到86.5%;此結果是以超過42,000名病患的配對活檢隊列作為對照衡量。

  • So we focus on the mutations most likely to prime a response. So that is the focus of our science. Two new reoccurring use products on the platform to model that looks digital AI portfolio grow quickly, detection that is both broad and precise with an expanded 63,000 patient evidence program behind it and an interception strategy that is novel. All resting on the depth first approach.

    因此,我們聚焦於最有可能啟動反應的突變。這就是我們科學工作的重點。平台上有兩項新的、反覆使用的產品,用於建模;看起來數位化的 AI 投資組合正在快速成長;其檢測同時具備廣度與精準度,背後有擴增至 63,000 名患者的證據計畫支撐,並且具備新穎的攔截策略。一切都建立在深度優先的方法之上。

  • With that, I'll turn it over to Luke.

    接下來我把時間交給 Luke。

  • Luke Power - Chief Financial Officer, Senior Vice President, Chief Accounting Officer

    Luke Power - Chief Financial Officer, Senior Vice President, Chief Accounting Officer

  • Thanks, David. I'll move relatively quickly through the numbers since we have touched on some of them already. We delivered another strong quarter with total revenue of $275.4 million, which is up 27% year over year and brings our nine-month revenue to $755.2 million, which is up 45% year to date. Molecular profiling revenue was $262.7 million, up 27%. And Pharma Research and Development Services revenue was $12.7 million, up 37% year over year.

    謝謝,David。由於我們先前已經提到其中一些數字,我會相對快速地帶過。我們再度交出強勁的一季,總營收為 2.754 億美元,年增 27%,使得我們前九個月營收達到 7.552 億美元,年初至今成長 45%。分子檢測(molecular profiling)營收為 2.627 億美元,年增 27%。而藥廠研發服務(Pharma Research and Development Services)營收為 1,270 萬美元,年增 37%。

  • As we have expanded our platform this year with new products and with MRD planned for launch later this quarter, we'll be moving to reporting total clinical volume only. This is consistent with how our sector reports and is the basis on which we'll report our preliminary full year volume in January and provide guidance numbers going forward. That said, I'll provide a little bit more context around the current quarter volume numbers.

    隨著我們今年以新產品擴展平台,且 MRD 計畫於本季稍晚推出,我們將改為僅揭露臨床總量(total clinical volume)。這與本產業的揭露方式一致,也將作為我們在 1 月公布全年初步量能以及未來提供指引數字的基礎。儘管如此,我仍會就本季量能數字提供一些額外背景。

  • Clinical and therapy selection volume in the third quarter was approximately 61,500 cases, up 21% year over year, ahead of the 20% milestone we outlined for the quarter. This volume excludes Caris Detect, whose revenue we will report in our Pharma Research and Developmental services line until it becomes material enough to break out along with its volume.

    第三季臨床與治療選擇(therapy selection)量能約為 61,500 例,年增 21%,高於我們為本季設定的 20% 里程碑。此量能不包含 Caris Detect;其營收在達到足以單獨揭露、並連同量能一併拆分之前,我們將先在藥廠研發服務(Pharma Research and Developmental services)項下揭露。

  • Therapy selection remains the core of our current volume. And in the two quarters since the Q1 sales realignment, volume has grown approximately 20% year over year, and we're encouraged by that momentum heading into Q4.

    治療選擇仍是我們目前量能的核心。而在第一季銷售重整後的兩個季度中,量能約年增 20%,我們對於進入第四季的這股動能感到鼓舞。

  • Therapy selection volume mix was in line with the trends from the past two quarters with tissue remaining the core. Both tissue and blood saw an acceleration in year-over-year growth rates from the second quarter and our overall growth rate of 21% was the highest it has been in over a year and is a testament to straight work being done by our sales and lab teams.

    治療選擇的量能組合與過去兩季的趨勢一致,仍以組織(tissue)為核心。組織與血液(blood)兩者的年增速率相較第二季皆有所加速;我們整體 21% 的成長率是超過一年來最高,這也證明了我們銷售與實驗室團隊所做的扎實工作。

  • For Caris Detect, we're pleased with the initial rollout, and we're continuing to expand our marketing with two campaigns now running, and we'll be expanding the markets as we progress into Q4 and beyond. Moving to gross margin. This was 66% in the quarter, reflecting the mix impact of our expanding product portfolio and we expect a similar level in Q4. That also reflects our focus on deeper, not cheaper, and you can see that by our recently upgraded Caris Assure assay, which is now running on the Illumina NovaSeq X platform with increased depth and reads.

    就 Caris Detect 而言,我們對初期推廣的成果感到滿意,並持續擴大行銷,目前已有兩個行銷活動在進行中;隨著我們進入第四季及之後,也將擴展市場。接著談毛利率。本季毛利率為 66%,反映我們擴增產品組合所帶來的組合影響;我們預期第四季將維持相近水準。這也反映我們「追求更深、而非更便宜」的聚焦;你可以從我們近期升級的 Caris Assure 檢測中看到,該檢測目前已在 Illumina NovaSeq X 平台上運行,具備更高的深度與讀取數(reads)。

  • Operating expenses were $163 million, up $48.1 million year over year and about $10 million sequentially. That increase was in line with our expectations as we continue to invest in the commercial organization, along with increased marketing dollars for Caris Detect and the development work on therapy response monitoring and Caris Confirm. Overall, these results produced GAAP net income of $15.3 million compared to $24.3 million a year ago.

    營業費用為 1.63 億美元,年增 4,810 萬美元,較前一季約增加 1,000 萬美元。這項增加符合我們的預期,因為我們持續投資商業組織,同時增加 Caris Detect 的行銷投入,以及治療反應監測(therapy response monitoring)與 Caris Confirm 的開發工作。整體而言,這些結果帶來 GAAP 淨利 1,530 萬美元,對比去年同期為 2,430 萬美元。

  • Year to date, net income is $14.1 million against a net loss of $150 million in the first nine months of 2025.

    年初至今,淨利為 1,410 萬美元;而 2025 年前九個月則為淨損 1.5 億美元。

  • Adjusted EBITDA was $44.4 million, our sixth consecutive positive quarter compared with $51.2 million in the prior year, which again carried a larger true-up benefit. Year-to-date adjusted EBITDA was $126.3 million, up from $31.7 million for the same nine months last year.

    調整後 EBITDA 為 4,440 萬美元,為連續第六季為正;相較去年同期為 5,120 萬美元,而去年同期同樣包含較大的追溯調整(true-up)利益。年初至今調整後 EBITDA 為 1.263 億美元,高於去年同期九個月的 3,170 萬美元。

  • Free cash flow was negative at $39.7 million in the quarter and included $17.5 million in capital expenditures. As we communicated in August, this was planned, as we use the free cash flow generated in the first half of the year to fund the ramp in inventory and the initiatives behind our pipeline. And you can see that in the working capital movements on the balance sheet.

    本季自由現金流為負 3,970 萬美元,其中包含 1,750 萬美元的資本支出。如同我們在 8 月所溝通的,這是計畫內安排;我們運用上半年所產生的自由現金流,來支應庫存拉升以及管線相關計畫。你也可以在資產負債表的營運資金變動中看到這點。

  • Through nine months, free cash flow is negative at $10.8 million and with inventory investment behind us, we expect to return to positive free cash flow in the fourth quarter and for the full year. We ended the quarter with $759.2 million in cash and investments, and we repurchased approximately $10 million of additional stock under authorized share repurchase program in Q3.

    前九個月自由現金流為負 1,080 萬美元;隨著庫存投資已告一段落,我們預期第四季以及全年將回到正的自由現金流。本季末我們持有現金與投資合計 7.592 億美元,且在第三季於已核准的庫藏股回購計畫下,額外回購約 1,000 萬美元股票。

  • Moving to slide 24. We continue to demonstrate strong growth across volume and ASP within our molecular profiling business. Blended ASP, base 3,990, up 19% year-over-year. and including prior period collections, blended ASP was $4,272, up 5%.

    接著看第 24 頁投影片。在分子檢測業務中,我們在量能與 ASP 方面持續展現強勁成長。混合 ASP(blended ASP)為 3,990 美元,年增 19%。若包含前期收款(prior period collections),混合 ASP 為 4,272 美元,年增 5%。

  • On the reimbursement front, we received the preliminary 2027 clinical lab fee schedule under PAMA cycle in September, like Cancer Seek was maintained at $8,455. However, Caris Assure was increased to $5,250, up from $3,650 and this is effective January 1, of 2027, subject to the final schedule later this year.

    在給付(reimbursement)方面,我們於 9 月收到 PAMA 週期下的 2027 年臨床實驗室費用表(clinical lab fee schedule)初步版本,其中 MI Cancer Seek 維持在 8,455 美元。不過,Caris Assure 上調至 5,250 美元,高於原先的 3,650 美元;該費率自 2027 年 1 月 1 日起生效,但仍須以今年稍晚公布的最終費用表為準。

  • This will also have a positive impact on the commercial contracts we've been signing as they are generally priced as a percentage of the clinical lab fee schedule rate. So the higher rate should lift realized ASP across the contracted book as we move into 2027, and that is the covered life strategy we described last quarter.

    這也將對我們正在簽署的商業合約帶來正面影響,因為其定價通常是以臨床實驗室費用表費率的一定百分比計價。因此,較高的費率應可在我們邁入 2027 年時,推升合約客戶組合(contracted book)的實現 ASP;這就是我們上季所描述的「覆蓋人數(covered lives)策略」。

  • We also received our first commercial plan payments for Caris ChromoSeq, and overall now, over live stand at approximately $264.4 million for MI Cancer Seek and $134.6 million for Caris Assure both up again from the second quarter.

    我們也收到 Caris ChromoSeq 的首筆商業保險方案(commercial plan)付款;整體而言,目前累計應收款(AR)約為:MI Cancer Seek 2.644 億美元,以及 Caris Assure 1.346 億美元,兩者皆較第二季再度上升。

  • Finally, turning to guidance. Given the strength of our first nine months, we're raising our full year outlook range to approximately $1.04 billion to $1.05 billion, up from $1.03 billion to $1.04 billion, representing growth of approximately 28% to 29%, driven by molecular profiling revenue, including prior period true-ups the guide implies four quarter growth in the 40% range, consistent with the underlying rate we delivered this quarter.

    最後談指引。鑑於前九個月表現強勁,我們將全年展望區間上調至約 10.4 億至 10.5 億美元,高於原先的 10.3 億至 10.4 億美元,代表約 28% 至 29% 的成長,主要由分子檢測營收帶動;若包含前期追溯調整(true-ups),該指引隱含第四季成長約在 40% 區間,與我們本季交付的基本成長率一致。

  • On a reported basis, our fourth quarter guidance range of $285 million to $95 million is broadly in line with the fourth quarter of 2025. which included roughly $90 million of true-ups due to the acceleration we experienced last year from our MI Cancer Seek FDA approval.

    以報表口徑(reported basis)來看,我們第四季指引區間為 2.85 億至 2.95 億美元,與 2025 年第四季大致相當。2025 年第四季包含約 9,000 萬美元的追溯調整(true-ups),係因去年我們在 MI Cancer Seek 取得 FDA 核准後所經歷的加速所致。

  • For the fourth quarter, we also expect clinical therapy selection volume to continue on the growth trend demonstrated the last couple of quarters, and to be approximately 60 to 5,000 cases and results in approximately 20% growth for the full year. We now expect GAAP operating expenses of approximately $620 million, up from approximately $600 million or a growth of approximately 26%. And that increase is deliberate. It funds the expanded commercial organization, the marketing behind Caris Detect, therapy responsible learning and Caris Confirm, along with processing of the R&D samples for the Achieve 2 internal read up.

    就第四季而言,我們也預期臨床治療選擇量能將延續過去幾季所展現的成長趨勢,約為 60,000 至 65,000 例,並使全年成長約 20%。我們目前預期 GAAP 營業費用約為 6.2 億美元,高於先前約 6.0 億美元,約成長 26%。而這項增加是刻意為之。其資金將用於擴大的商業組織、Caris Detect 的行銷、治療反應學習(therapy responsible learning)與 Caris Confirm,以及為 Achieve 2 內部讀出(internal read up)而進行的研發樣本處理。

  • And we continue to expect both positive adjusted EBITDA and free cash flow to be positive for the full year. Adjusted EBITDA is already $126.3 million through nine months, and we expect free cash flow to return to positive in the fourth quarter, bringing the full year to modestly positive, all while funding our growth initiatives that we just walked through.

    我們仍然預期全年調整後 EBITDA 與自由現金流都將為正。調整後 EBITDA 在前九個月已達 1.263 億美元,我們預期自由現金流將在第四季回到正值,使全年達到小幅正值,同時也持續為我們剛才說明的成長計畫提供資金。

  • With that, I'll wrap up the presentation and turn it back to the operator and open it up for questions. Operator?

    到此我將結束簡報,交還給主持人並開放提問。主持人?

  • Operator

    Operator

  • (Operator Instructions) Vijay Kumar, Evercore.

    (主持人指示)Vijay Kumar,Evercore。

  • Vijay Kumar - Equity Analyst

    Vijay Kumar - Equity Analyst

  • Hey, guys. Thanks for taking my questions. Congrats on a nice print in the quarter. Luke, maybe my first question for you on -- I know you mentioned both tissue and blood volumes accelerated. But maybe if you could just give a little bit more color on the pace of acceleration tissue versus blood and a similar sort of commentary on ASPs, please? Where the increase come from? And ASPs were up 9%?

    嗨,各位。謝謝讓我提問。恭喜本季交出漂亮的成績。Luke,我第一個問題想請教你——我知道你提到組織與血液的量都加速成長。但能否請你再多分享一些:組織相較於血液的加速幅度/速度如何?另外也請對 ASP(平均售價)做類似的說明?這次的提升主要來自哪裡?而且 ASP 上升了 9%?

  • Luke Power - Chief Financial Officer, Senior Vice President, Chief Accounting Officer

    Luke Power - Chief Financial Officer, Senior Vice President, Chief Accounting Officer

  • Yeah. Yes. So Vijay, like as we said in our remarks, we won't be breaking it out separately going forward. But what I can say and what I disclosed is the mix trend is consistent with what you saw from Q1 to Q2. So blood continues to grow and tissue continues to grow.

    是的。Vijay,如同我們在發言中提到的,未來我們不會再分開揭露。但我可以說、也已揭露的是:組合(mix)趨勢與你從第一季到第二季看到的一致。也就是血液持續成長、組織也持續成長。

  • So the growth rate increased from what we reported last quarter, which is excellent and in line with our expectations. And I think we can continue to overdeliver on that as we progress into Q4. From an ASP standpoint, again, similar to last quarter, from a blended ASP, we continue to see strength in what our market access teams and our billing teams are doing.

    因此,成長率相較於我們上季所報告的有所提升,這非常好,也符合我們的預期。我認為隨著我們進入第四季,仍可持續超越預期。就 ASP 而言,同樣地,與上季類似,從綜合 ASP(blended ASP)的角度,我們持續看到市場准入團隊與帳務/收費團隊的工作帶來的強勁表現。

  • So, we've had success across both Caris Assure and MI Cancer continuing to get coverage there. So for us, our expectation is that's going to continue to improve into the fourth quarter. And with the guidance that we put out, we're in a similar range of around that 4,000 days ASP, which would be a new record for us. So overall, feel great, but the mix and everything is going according to plan.

    因此,我們在 Caris Assure 與 MI Cancer 兩者的給付涵蓋(coverage)拓展上都取得進展。所以我們預期這個趨勢在第四季會持續改善。依我們給出的指引,我們仍在約 4,000 美元左右的 ASP 區間,這將會是我們的新紀錄。整體而言感覺非常好,組合與各項進展都按計畫進行。

  • Vijay Kumar - Equity Analyst

    Vijay Kumar - Equity Analyst

  • That's helpful. And maybe a big picture question. If I just look at how the year has progressed, right, your volumes have accelerated every quarter, and your fourth quarter guidance implies another step up to maybe perhaps 23-plus on clinical volume.

    很有幫助。再問一個較宏觀的問題。如果我看今年的進展,你們的量每一季都在加速,而你們第四季指引意味著還會再往上一步,臨床量可能到 23%以上。

  • So when you look at the progression and the fact that you have new test up launching, should '27 clinical volumes accelerate from '26 levels of 20%, would that be a fair assumption?

    所以當你看這樣的進程,加上你們有新檢測即將上市,是否可以合理假設:2027 年的臨床量相較 2026 年 20% 的水準會再加速?

  • Luke Power - Chief Financial Officer, Senior Vice President, Chief Accounting Officer

    Luke Power - Chief Financial Officer, Senior Vice President, Chief Accounting Officer

  • It's a fair assumption. What we're not doing right now, though, is guiding to 2027 volume. The key for us coming into this year was kind of twofold. One was obviously doing the expansion in commercial or but the second was pushing out the pipeline as quickly as possible. Because we have unique tests and because they're the most comprehensive, we wanted to get through the end of the year with all those tests on the market, which what we're striving for and will accomplish. So we feel very good about that.

    這是合理的假設。不過我們目前不會對 2027 年的量提供指引。我們今年的重點大致有兩個。第一當然是商業端的擴張;第二是盡可能快速推進產品管線。因為我們的檢測具獨特性、且是最全面的,我們希望在年底前讓所有這些檢測都上市;這正是我們努力的方向,也會達成。因此我們對此非常有信心。

  • I think as we start looking towards 2027, the key for us was correcting the therapy selection growth and seeing acceleration both in tissue and blood this quarter, which is great. It shows the commercial plan is paying off.

    我認為當我們開始展望 2027 年時,關鍵在於我們已修正治療選擇(therapy selection)的成長動能,並且本季在組織與血液兩端都看到加速,這很棒。這顯示商業計畫正在奏效。

  • And then as we progress into next year with the rollout of Monitoring and with the rollout of Confirm, we'll do that in another disciplined [digital] way as we work through the reimbursement pathways, but it definitely should contribute on the top line because it's the existing sales force selling the products.

    接著,隨著我們明年推進 Monitoring 的推出以及 Confirm 的推出,我們會在處理給付/報銷(reimbursement)路徑的同時,以同樣有紀律的方式推動;但它確實應該會對營收端(top line)有所貢獻,因為是由現有的銷售團隊來銷售這些產品。

  • Vijay Kumar - Equity Analyst

    Vijay Kumar - Equity Analyst

  • Thank you.

    謝謝。

  • Operator

    Operator

  • Subbu Nambi, Guggenheim.

    Subbu Nambi,Guggenheim。

  • Subbu Nambi - Equity Analyst

    Subbu Nambi - Equity Analyst

  • Hey, guys. Thank you for taking my question. ChromoSeq and MI Clarity now have about two quarters of commercial history. Are they in the updated guide? How did each ramp in the quarter and when do they become meaningful contributors?

    嗨,各位。謝謝讓我提問。ChromoSeq 和 MI Clarity 現在大約有兩季的商業化歷史。它們有納入更新後的指引嗎?這一季各自的爬坡(ramp)情況如何?以及它們何時會成為有意義的貢獻者?

  • Luke Power - Chief Financial Officer, Senior Vice President, Chief Accounting Officer

    Luke Power - Chief Financial Officer, Senior Vice President, Chief Accounting Officer

  • Yeah. So they're obviously a smaller portion, and that's why I referenced the mix from the last couple of quarters, but they're continuing to grow, but they're obviously not at the same scale as what we're doing. We have tissue in our blood assays. So they'll continue to grow as we progress at the next couple of quarters.

    有的。所以它們顯然占比仍較小,這也是我提到過去幾季的組合趨勢的原因;但它們確實持續成長,只是規模還不如我們目前的主力業務。我們的檢測主要是組織與血液。因此在接下來幾季,它們會隨著我們的推進而持續成長。

  • The 65,000 cases is for kind of key therapy selection. So it would include a small portion from them, but not a whole loss. As you can see from what we reported last quarter on what we're actually disclosing this quarter, I think you'll see that continue to improve, but it's not as big of a market right now as for tissue and blood.

    6.5 萬例(cases)主要是指核心的治療選擇(therapy selection)。因此其中會包含它們的一小部分,但不會占很大比重。如你從我們上季的揭露以及本季我們實際揭露的內容所見,我認為你會看到它持續改善,但就目前而言,它的市場規模不如組織與血液那麼大。

  • Subbu Nambi - Equity Analyst

    Subbu Nambi - Equity Analyst

  • No, look. I was trying to get at when do they become meaningful contributors? And I also have a follow-up.

    不,我的意思是:它們什麼時候會成為有意義的貢獻者?另外我還有一個追問。

  • Luke Power - Chief Financial Officer, Senior Vice President, Chief Accounting Officer

    Luke Power - Chief Financial Officer, Senior Vice President, Chief Accounting Officer

  • Yeah, I think as we progress into the end of the year and into next year, you'll start to see them continue to grow along with MI Clarity. I think right now, as we're looking at the guidance for the remainder of the year, they're not material compared to the blood and tissue.

    我認為隨著我們走到年底並進入明年,你會開始看到它們與 MI Clarity 一樣持續成長。但就我們對今年剩餘期間的指引來看,相較於血液與組織,它們目前並不具重大性(not material)。

  • Subbu Nambi - Equity Analyst

    Subbu Nambi - Equity Analyst

  • Got it. So think of it as more '27 rather than this year. On the enhanced Caris Assure that adds the track table for response monitoring, you plan to pursue MolDX reimbursement for it, when do you plan to submit to MolDX and do you have the data that you need or you're still generating it?

    了解。所以可以把它視為更偏向 2027 年,而不是今年。關於升級版 Caris Assure(新增用於反應監測的追蹤表),你們計畫為它申請 MolDX 給付;你們預計何時向 MolDX 提交?你們已具備所需數據,還是仍在產生中?

  • Luke Power - Chief Financial Officer, Senior Vice President, Chief Accounting Officer

    Luke Power - Chief Financial Officer, Senior Vice President, Chief Accounting Officer

  • Yeah. Spetz, do you want to take that one?

    是的。Spetz,你要回答這題嗎?

  • David Spetzler - President, Chief Scientific Officer

    David Spetzler - President, Chief Scientific Officer

  • Yeah. We've completed the trial. So we're working on that submission now. It should happen in the next several months. Well, we need to publish it first, and it's always hard to take how long publication process takes.

    好的。我們已完成試驗。所以我們正在準備那份提交資料。應該會在接下來幾個月內進行。不過我們需要先發表(publish)研究,而發表流程需要多久一向很難預估。

  • Subbu Nambi - Equity Analyst

    Subbu Nambi - Equity Analyst

  • That's fair. And last one, what percentage of blood tests were attached to tissue test in the quarter? You've always hovered around 30%. Should we expect the same thing? Or have you seen that attachment grow meaningfully?

    合理。最後一題:本季血液檢測中,有多少比例是與組織檢測一起搭配(attached)?你們過去大多在 30% 左右。我們應該預期仍是同樣水準嗎?還是你們看到這個搭配率有顯著提升?

  • Luke Power - Chief Financial Officer, Senior Vice President, Chief Accounting Officer

    Luke Power - Chief Financial Officer, Senior Vice President, Chief Accounting Officer

  • We've seen it grow, and probably not meaningfully. It has increased past 40%. So it's been at 42% for third quarter, but not material past that.

    我們看到它有成長,但可能稱不上顯著。它已提升到 40% 以上。第三季是 42%,但沒有再大幅高於此。

  • Subbu Nambi - Equity Analyst

    Subbu Nambi - Equity Analyst

  • Perfect. Thank you, guys.

    完美。謝謝各位。

  • Operator

    Operator

  • [Lily], Bank of America.

    [Lily],美國銀行(Bank of America)。

  • Unidentified Participant

    Unidentified Participant

  • Great. Thank you for taking my questions. I guess, I want to clarify, the Karstadt is now in the R&D line, the fab R&D line. Is that true also in 3Q? And then also related questions to that, so in terms of the 4Q guide, like how do you talk about breakout between the profiling business and then also the R&D? Any assumption would be great.

    很好。謝謝讓我提問。我想確認一下:Karstadt 現在是歸在研發費用項下,也就是製造/廠務(fab)研發那一行。第三季也是如此嗎?另外也相關地,就第四季指引而言,你們如何看待 profiling 業務與研發之間的拆分(breakout)?任何假設說明都會很有幫助。

  • Luke Power - Chief Financial Officer, Senior Vice President, Chief Accounting Officer

    Luke Power - Chief Financial Officer, Senior Vice President, Chief Accounting Officer

  • Yeah. So yes, so Detect will be reported in there until we have a couple of more quarters. It's consistent with what we've kind of disclosed in the past with any new product launches. We'll continue to monitor it, but when it becomes material, it wasn't -- it was small compared to the relative $275 million we put up. So we haven't broken it out yet, but we'll continue to, obviously -- we feel really good about where it's going.

    是的。所以是的,Detect 會先在那裡被揭露,直到我們再多跑幾個季度。這與我們過去對任何新產品上市所做的披露方式一致。我們會持續監測,但當它變得具重大性時——相較於我們達到的約 2.75 億美元,它當時還很小。所以我們還沒有把它單獨拆出來,但我們會持續——很明顯地——我們對它的發展方向感到非常樂觀。

  • I think as we look forward to Q4, it doesn't include any of the new products. We'll continue to do that from a guidance standpoint. We always like to wait a couple of quarters before we start looking at including additional new products in there. So the breakdown for Q4 is effectively about $265 million for molecular profiling and then the range between the $30 million for pharma, and that doesn't include any Detect.

    我想展望第四季,它不包含任何新產品。從財測指引的角度,我們會繼續這樣做。我們一向喜歡先等上幾個季度,再開始考慮把額外的新產品納入其中。所以第四季的拆分基本上是:分子特徵分析約 2.65 億美元,藥廠約 3,000 萬美元的區間,而這不包含任何 Detect。

  • Unidentified Participant

    Unidentified Participant

  • That's very helpful. And then on the MRD launch. I'm wondering, can you just talk a little bit about kind of your reimbursement process, definitely like cancer, like indication by indication, but do you have like any timeline, in terms of when are we going to see the first indication reimbursement?

    這非常有幫助。接著關於 MRD 的上市。我想請教,你們能否稍微談一下你們的給付(reimbursement)流程?確實像癌症這類是按適應症逐一推進,但你們是否有任何時間表,例如我們何時會看到第一個適應症獲得給付?

  • Luke Power - Chief Financial Officer, Senior Vice President, Chief Accounting Officer

    Luke Power - Chief Financial Officer, Senior Vice President, Chief Accounting Officer

  • Do you want to take Spetz or I can?

    你想讓 Spetz 回答,還是我來?

  • David Spetzler - President, Chief Scientific Officer

    David Spetzler - President, Chief Scientific Officer

  • Yeah. It's kind of the same. So we've completed our first trial, need to publish that one in colorectal cancer, and then we'll be able to submit to MolDX.

    是的,基本上差不多。所以我們已完成第一項試驗,需要把那項在大腸直腸癌的研究發表出來,之後我們就能向 MolDX 提交。

  • Unidentified Participant

    Unidentified Participant

  • So I guess, we'll be to by 2027, will be kind of like coming?

    所以我猜,大概到 2027 年就會——算是會到來?

  • David Spetzler - President, Chief Scientific Officer

    David Spetzler - President, Chief Scientific Officer

  • Yes.

    是的。

  • Unidentified Participant

    Unidentified Participant

  • Okay, thank you.

    好的,謝謝。

  • Operator

    Operator

  • [Adam Winslow], UBS.

    [Adam Winslow],瑞銀(UBS)。

  • Unidentified Participant

    Unidentified Participant

  • Thank you for taking my question. You mentioned that Assure is going to move to the higher CLFS rate in January. I'm just curious how you thought that magnitude and timing of the benefit to realize ASP in 2027, particularly as you've mentioned, commercial contracts are generally priced as a percentage of that CLFS rate? Thank you.

    謝謝讓我提問。你提到 Assure 將在一月調升到較高的 CLFS 費率。我想了解你們如何看待這項調升在 2027 年對可實現 ASP(平均售價)的效益幅度與時間點,特別是你們提到商業合約通常是以該 CLFS 費率的一定百分比來定價?謝謝。

  • Luke Power - Chief Financial Officer, Senior Vice President, Chief Accounting Officer

    Luke Power - Chief Financial Officer, Senior Vice President, Chief Accounting Officer

  • Yeah. Adam, yeah. So we feel actually excellent about that. It should be pretty immediate for -- especially for the contracts that we've signed and obviously for Medicare itself. So, for Q1 and Q2, we would expect to see the bulk of the step up there.

    是的。Adam,是的。所以我們其實對此非常有信心。它應該會相當立即地反映——特別是對我們已簽署的合約,當然也包括 Medicare 本身。因此在第一季和第二季,我們預期會看到大部分的上調幅度反映在那裡。

  • We continue to make progress with other payers where we're not covered right now. And obviously, that proposed increase that will come into effect January 1, we'll also help with those negotiations. So we would expect it to be a kind of Q1 and Q2 impact, primarily Q1 though.

    我們也持續在目前尚未涵蓋的其他付款方(payers)上取得進展。而且,這項擬議的調升將於 1 月 1 日生效,也會有助於這些談判。所以我們預期影響會主要落在第一季和第二季,但以第一季為主。

  • Unidentified Participant

    Unidentified Participant

  • Thank you. And you also mentioned that the Detect interest remains ahead of expectations, but you don't intend to chase demand by overspending. So how are you measuring kind of the response to the initial rollout and deciding how aggressively to scale that investment up?

    謝謝。你也提到 Detect 的興趣仍高於預期,但你們不打算為了追逐需求而過度花費。那你們如何衡量初期推廣的反應,並決定要多積極地擴大這項投資?

  • Luke Power - Chief Financial Officer, Senior Vice President, Chief Accounting Officer

    Luke Power - Chief Financial Officer, Senior Vice President, Chief Accounting Officer

  • Yeah, similar to how we approach everything. And when we say disciplined, like what we want to do and 1 of the unique positions we're in is, obviously, we're funding all these initiatives ourselves. So, free cash flow negative was a one-time event because we did that initial inventory purchase, and we feel great about how the tech is going.

    是的,跟我們處理所有事情的方式類似。當我們說「有紀律」,我們想做的是——而且我們所處的一個獨特位置是,很明顯地,我們是用自有資金在支持所有這些計畫。所以自由現金流為負是一次性的事件,因為我們做了那筆初始庫存採購,而我們對技術進展感到非常滿意。

  • So what we're doing is we're continuing to assess, obviously, with our partners, the pull-through and we feel good about that, and we're continuing to expand the partnerships as well. So we'll work through data in Q4.

    所以我們正在做的是,持續與合作夥伴一起評估拉動效應(pull-through),我們對此感覺良好,同時也持續擴大合作關係。因此我們會在第四季消化並檢視相關數據。

  • Also, with the actual ad campaign, we launched that in selected markets. We haven't broadly launched it fully yet, and we'll continue to assess that on a quarterly-by-quarterly basis. One of the key things, and we said this on last quarter's call is we're always aware of kind of the potential for this test and the capacity constraints on it. So that's why we're taking the disciplined approach with rolling it out market by market, and we'll continue to assess that as we go into the end of the year and next year.

    另外,就實際的廣告活動而言,我們是在特定市場推出。我們尚未全面大規模推出,並會以逐季的方式持續評估。其中一個關鍵點——我們在上一季的電話會議也提過——是我們一直意識到這項檢測的潛在需求,以及其產能限制。因此我們才採取有紀律的方式,按市場逐一推進,並會在今年底以及明年持續評估。

  • Unidentified Participant

    Unidentified Participant

  • Thank you.

    謝謝。

  • Operator

    Operator

  • Casey Woodring, JPMorgan.

    Casey Woodring,摩根大通(JPMorgan)。

  • Casey Woodring - Analyst

    Casey Woodring - Analyst

  • Great. Thank you for taking my questions. I guess the first one, can you just elaborate on the MSEB launch? And if you can get specific, how many MSEB tests did you sell in the quarter? And I guess, what's baked into the 4Q guidance?

    很好。謝謝讓我提問。第一個問題,你能否再詳細說明一下 MSEB 的上市?如果可以更具體,你們本季賣出了多少個 MSEB 檢測?以及第四季指引中包含了哪些假設?

  • Luke Power - Chief Financial Officer, Senior Vice President, Chief Accounting Officer

    Luke Power - Chief Financial Officer, Senior Vice President, Chief Accounting Officer

  • Yeah, Casey, there's nothing baked into the 4Q guidance. And right now, as we said in the prepared remarks, we're going to include it in the research line until we have more and more activity flow through before we break it out. We'll continue to assess that but there's nothing in the guide for Q4.

    是的,Casey,第四季指引裡沒有納入任何 MSEB。而且目前如同我們在事先準備的講稿中所說,在我們看到更多活動量逐步反映之前,我們會先把它放在研究(research)項目裡,等到更成熟再單獨拆出來。我們會持續評估,但第四季指引中沒有包含。

  • Casey Woodring - Analyst

    Casey Woodring - Analyst

  • Okay, understood. And then I think if I'm doing the math right, pharma R&D 4Q revenue is something in the $20 million to $30 million range. I guess, that implies a pretty big cut to the full year number. So maybe just walk through kind of what you're seeing in the pharma ran service business to end the year and expectations for that business line moving forward?

    好的,了解。另外我想如果我算得沒錯,藥廠研發(pharma R&D)第四季營收大概在 2,000 萬到 3,000 萬美元之間。我想這意味著全年數字會被大幅下修。所以能否說明一下你們在年底前看到的藥廠研發服務業務狀況,以及對這條業務線未來的預期?

  • Luke Power - Chief Financial Officer, Senior Vice President, Chief Accounting Officer

    Luke Power - Chief Financial Officer, Senior Vice President, Chief Accounting Officer

  • Yes. Yes. So Casey, so you've seen the trends like since the beginning of the year, that's also improved sequentially from a revenue standpoint. It's a business that we've obviously not been focused on in the past, but we're starting to gain traction. And one of the key things that we were focused on coming into the year is not focusing on smaller deals, but more, larger long-term deals. And the sales cycle for those continue to be kind of a little bit longer.

    是的,是的。所以 Casey,你已經看到自年初以來的趨勢,從營收角度也呈現逐季改善。這是一項我們過去並未特別聚焦的業務,但我們正開始取得進展。而我們今年一開始聚焦的一個關鍵點,是不去做較小的案子,而是更多、更大型的長期合約。而這些案子的銷售週期仍然會稍微長一些。

  • But going into Q4 with that guidance, we feel really good about that stepping up to over 100% growth. We think we can maintain that momentum then as we continue to build out the team into 2027. I think from an overall standpoint, like we feel really good about where our revenue and is on a total basis. And that's where I feel confident, obviously, with the guidance. And that's why the only range is around that pharma because we have a couple of deals we're concrete to pipe, and it's more of a timing issue.

    但以第四季的指引來看,我們對成長提升到超過 100% 感到非常有信心。我們認為隨著我們在 2027 年持續擴編團隊,可以維持這股動能。我想從整體角度來看,我們對總體營收的表現與走勢感到非常滿意。這也是我對指引有信心的原因。而且之所以只有藥廠那一塊有區間,是因為我們有幾筆交易已經很接近進入管線,更多是時間點的問題。

  • Casey Woodring - Analyst

    Casey Woodring - Analyst

  • Understood. Thank you.

    了解。謝謝。

  • Operator

    Operator

  • Albert Hu, Citi.

    Albert Hu,花旗(Citi)。

  • Albert Hu - Analyst

    Albert Hu - Analyst

  • Hi, perfect. Thanks for taking the question. So maybe just jumping off Casey's question on MSEB. So you guys currently have that in the pharma R&D side of things. So when do you guys expect volumes for MSEB to really ramp up here? Is this going to be like a 2028, 2029 situation when the reimbursement likely comes on? Or how are you guys thinking about that going forward?

    嗨,很好。謝謝讓我提問。那我就接續 Casey 關於 MSEB 的問題。你們目前把它放在藥廠研發(pharma R&D)這一側。那你們預期 MSEB 的量在這裡何時會真正開始放量成長?這會是像 2028、2029 那樣、等到可能取得給付後才會發生的情況嗎?或者你們接下來是如何思考的?

  • Luke Power - Chief Financial Officer, Senior Vice President, Chief Accounting Officer

    Luke Power - Chief Financial Officer, Senior Vice President, Chief Accounting Officer

  • No. Again, Albert, like what we're doing with MSEB, it's self-pay, it's direct-to-consumer. So it's different from what others are doing. Because one of the key reasons we're doing that is we want to make sure it's focused on the technology. Like, technology should drive, obviously, the signs and that should drive how you approach the market.

    不。再說一次,Albert,就像我們對 MSEB 所做的一樣,這是自費模式,是直接面向消費者(direct-to-consumer)。所以這和其他人正在做的事情不同。因為我們這麼做的一個關鍵原因,是我們希望確保它聚焦在技術上。也就是說,技術應該驅動(產品的)訊號,而這又應該驅動你如何切入市場。

  • So that's one of the differentiation factors here versus all the other approaches that are out there that are utilizing the same sales force going to PCP. So we do expect it to continue to ramp. And again, that's dependent upon how quickly we want to put our foot on the gas from a campaign standpoint. And that's where we said in the prepared remarks, we're not going to overspend by doing this, but we're going to do it smartly.

    所以,這是相較於市面上所有其他做法的一個差異化因素;那些做法都在使用同一套銷售隊伍去拜訪 PCP(基層照護醫師)。所以我們確實預期它會持續爬坡成長。而且再說一次,這取決於從行銷活動的角度,我們想多快把油門踩下去。這也是我們在事先準備的講稿裡提到的:我們不會為了做這件事而過度花費,但我們會用更聰明的方式來做。

  • And we feel really good about where it's at today and that increased penetration that we're seeing. So I would expect it to continue to ramp trip the next couple of quarters. And again, we'll assess it as we get into 2027, how much we want to spend on the ad campaign, but we're going to be smart about it.

    我們對目前的進展以及我們看到的滲透率提升感到非常滿意。所以我預期接下來幾個季度會持續爬坡成長。同樣地,等我們進入 2027 年時,我們會評估想在廣告活動上投入多少,但我們會很謹慎、很聰明地做。

  • Albert Hu - Analyst

    Albert Hu - Analyst

  • Okay. That's helpful. And then maybe as a follow-up. So last quarter, you mentioned that there are some sequencing competitors out there with higher throughput with lower cost compared to the dominant supplier that you guys are on right now. So is there any sort of switch and process for you guys that's happening AKA do you expect COGS to come down further because of this? Or what's the thoughts on COGS going forward?

    好的。這很有幫助。那接著可能再追問一下。上個季度你提到,市面上有一些定序(sequencing)競爭對手,相較於你們目前所使用的主導供應商,具備更高的通量、且成本更低。所以你們是否正在進行任何切換或流程上的調整?也就是說,你們是否預期因此 COGS(銷貨成本)會進一步下降?或者你們對未來 COGS 的看法是什麼?

  • Luke Power - Chief Financial Officer, Senior Vice President, Chief Accounting Officer

    Luke Power - Chief Financial Officer, Senior Vice President, Chief Accounting Officer

  • Yeah. Yeah. Look, I definitely think there's opportunity on the COGS front. I think we're -- we stated this on previous earnings calls, we're technology agnostic. I think more competition is better, and we continue to assess. So there's definitely opportunity as we progress into 2027, and beyond. And it's going to continue to come down.

    是的。是的。你看,我確實認為在 COGS 方面有機會。我想我們在之前的財報電話會議上也說過:我們對技術路線是中立的(technology agnostic)。我認為競爭越多越好,我們也會持續評估。所以當我們邁向 2027 年以及之後,確實有機會。而且它會持續下降。

  • So -- but again, our focus right now is to create the best technology, not focus on COGS. You see that from our next our upgraded version of Caris Assure. Like again, we went deeper and not cheaper, we could have made that and improve the margin. But again, we want to get the data. We want to ensure it's the best test on the market.

    所以——但再說一次,我們目前的重點是打造最好的技術,而不是把焦點放在 COGS 上。你可以從我們下一代、升級版的 Caris Assure 看出來。再說一次,我們選擇做得更深入,而不是做得更便宜;我們本來可以那樣做並改善毛利。但我們想要取得數據。我們想確保它是市場上最好的檢測。

  • So we always utilize that approach before we actually start focusing on the unit economics. But I think as we progress into 2027, with all our tests on the market. That's where you'll start to see the benefit flow to improve the margin, and we feel pretty confident about that regardless of supply vendor.

    所以在我們真正開始聚焦單位經濟(unit economics)之前,我們總是先採取這樣的做法。但我認為,當我們邁向 2027 年、且我們所有檢測都在市場上之後,你就會開始看到這些效益反映在毛利改善上;而且不論供應商是哪一家,我們對此都相當有信心。

  • Albert Hu - Analyst

    Albert Hu - Analyst

  • All right. Thanks so much.

    好的。非常感謝。

  • Operator

    Operator

  • Mark Massaro, US Bancorp BTIG.

    Mark Massaro,美國合眾銀行 BTIG。

  • Unidentified Participant

    Unidentified Participant

  • This is Megan on for Mark. So following the positive FDA AdCom, we'd be curious to learn if that might give you any desire to pursue FDA and approval for Detect?

    我是 Megan,代替 Mark 提問。那麼在 FDA 諮詢委員會(AdCom)給出正面結果之後,我們想了解這是否會讓你們更有意願為 Detect 走 FDA 路徑並取得核准?

  • Luke Power - Chief Financial Officer, Senior Vice President, Chief Accounting Officer

    Luke Power - Chief Financial Officer, Senior Vice President, Chief Accounting Officer

  • Yeah. I definitely -- yes, go ahead, Spetz.

    是的。我確實——是的,Spetz,你先說。

  • David Spetzler - President, Chief Scientific Officer

    David Spetzler - President, Chief Scientific Officer

  • You can do, Luke. It's fine.

    Luke,你可以回答,沒問題。

  • Luke Power - Chief Financial Officer, Senior Vice President, Chief Accounting Officer

    Luke Power - Chief Financial Officer, Senior Vice President, Chief Accounting Officer

  • Yeah. I think like -- obviously, I definitely think we consider it. But as I previously just stated, too, I think our focus is always going to be on technology first rather than the FDA pathway in order to secure reimbursement down the path. I think if you focus on reimbursement initially, it could limit the kind of performance of your test because you're trying to create a test and cite a particular margin. again, that's not of our approach.

    是的。我想——很明顯,我們確實會考慮。但如我剛才也提到,我認為我們的重點永遠會是先把技術做好,而不是先走 FDA 路徑來在後續取得給付(reimbursement)。我認為如果一開始就把焦點放在給付上,可能會限制你檢測的表現,因為你是在試圖做出一個檢測並鎖定某個特定的利潤率。再說一次,那不是我們的做法。

  • So the FDA is not in our near-term future for that. But again, we'll continue to assess the overall macro environment as it progresses over the next couple of years. But right now, our focus is on, obviously, returning at the achieved 2 interim readout in Q1, hopefully, early Q1.

    所以 FDA 對我們來說不是短期內的規劃。但我們會隨著未來幾年整體宏觀環境的演變持續評估。不過目前,我們的重點顯然是在 Q1 取得 Achieve 2 的期中讀出(interim readout),希望是在 Q1 初期。

  • And and then completing that study and then expanding with what Dr. Spetzler said about the Achieve 3 and Achieve 4 to show the continued performance of a whole genome approach, which is unique. So I think that's more our strategy right now around the trials, and we'll assess the FDA pathway as we progress through that.

    然後完成那項研究,並且如 Spetzler 醫師所說,透過 Achieve 3 與 Achieve 4 的擴展,來展示全基因體(whole genome)方法的持續表現,而這是獨特的。所以我想,這就是我們目前在試驗方面的策略;我們也會在推進過程中評估 FDA 路徑。

  • Unidentified Participant

    Unidentified Participant

  • Understood. Thank you for the color. And then we were also -- again, on Caris Detect, it was the ad campaign launch. So just curious if you have any color on the feedback of the launch? And yeah, anything you've heard that can speak to that.

    了解。謝謝你們提供的補充說明。另外我們也想——同樣是關於 Caris Detect,是廣告活動的啟動。所以想請教你們是否能分享一些啟動後的回饋?以及你們聽到的任何可以反映成效的資訊。

  • Luke Power - Chief Financial Officer, Senior Vice President, Chief Accounting Officer

    Luke Power - Chief Financial Officer, Senior Vice President, Chief Accounting Officer

  • Yeag, it's been feedback has been positive. Again, it's a unique approach. I think people appreciated that. That's some of the kind of key feedback we're getting. The performance in Stage 1 and Stage 2 is obviously the best key metric for any early-stage detection test.

    是的,回饋一直是正面的。再說一次,這是一種獨特的方法。我想大家很欣賞這一點。這是我們收到的一些關鍵回饋。而第一期與第二期(Stage 1、Stage 2)的表現,顯然是任何早期偵測檢測最重要的關鍵指標。

  • And that's why David said the opening too, that's our focus. It's early stage, Stage 1 and Stage 2, where you can make a difference. So I think there's been a positive response to that. Again, we're being disciplined with how we roll this out, and we're going to continue to increase the marketing behind it, but not overspend, as David said in the opening.

    這也是 David 在開場時提到的:那就是我們的重點。是在早期、也就是第一期與第二期,你才能真正帶來改變。所以我認為市場對此有正面反應。同樣地,我們在推廣節奏上會保持紀律,我們會持續加大行銷力道,但不會過度花費,正如 David 在開場所說。

  • So it's been positive. We'll continue to assess and then we'll continue to monitor it going forward.

    所以目前是正面的。我們會持續評估,並在後續持續監測。

  • Unidentified Participant

    Unidentified Participant

  • Great. Thank you, guys.

    很好。謝謝各位。

  • Operator

    Operator

  • Dan Brennan, TD Cowen.

    Dan Brennan,TD Cowen。

  • Daniel Brennan - Analyst

    Daniel Brennan - Analyst

  • Great. Thank you for the question. I joined late, but I think I'm caught up. Maybe just on the fourth quarter volume guide, the 65,000, which is consistent I know there is a step up there. You've got the expanded sales force, which you guys must feel good about. Is there a cushion in that number since the number this quarter was just about what you guys expected on the volume side, price was a big upside drivers. So just thinking about the fourth quarter volume, how do you guys feel about that?

    很好。謝謝讓我提問。我比較晚加入,但我想我已經跟上進度了。想請教一下第四季的量能指引:65,000,這我知道是一致的,而且看起來有一個向上的台階。你們擴編了銷售團隊,想必你們對此感覺不錯。那這個數字裡是否有留一些緩衝?因為本季的量大概就是你們原先預期的水準,但價格是很大的超預期驅動因素。所以就第四季量能而言,你們對這個目標的把握度如何?

  • Luke Power - Chief Financial Officer, Senior Vice President, Chief Accounting Officer

    Luke Power - Chief Financial Officer, Senior Vice President, Chief Accounting Officer

  • We feel very good about that. So obviously, we'll guide to what we expect the numbers to be. So the 65,000 is the expectation, along with the because it closed with our plan at the beginning of the year, which obviously we beat again by 1 percentage point in Q3, but we continue to assess and we continue to believe that 20% is kind of the guide number for now. Definitely, as we progress throughout the quarter, we've been -- we feel very positive about our volume numbers.

    我們對此非常有信心。所以很明顯,我們會以我們預期的數字來提供指引。因此 65,000 是我們的預期;同時,因為它與我們年初的計畫一致——我們在第三季又超出 1 個百分點——但我們會持續評估,而我們也持續認為目前 20% 大致上仍是指引數字。當然,隨著季度推進,我們——我們對我們的量能數字感到非常正面。

  • Daniel Brennan - Analyst

    Daniel Brennan - Analyst

  • Thanks, Luke. And I think there was a question asked earlier about potentially 20% volume growth in '27. I know you guys aren't guiding. But at the same time, I know you've also talked about taking a conservative stance when you get to the point of guiding. So any way to think about like will there be some natural kind of cushion that you do bake in for next year? Or is your point you're just going to use this year's number and just kind of roll that forward.

    謝謝,Luke。我想先前有人問到,到了 2027 年是否可能有 20% 的量成長。我知道你們目前不提供指引。但同時我也知道,你們也談過在開始提供指引時會採取較保守的立場。所以,有沒有什麼方式可以理解,例如你們在做明年指引時,是否會自然地預留一些緩衝?或者你的意思是,你們就只是用今年的數字,然後大致往前延用?

  • Luke Power - Chief Financial Officer, Senior Vice President, Chief Accounting Officer

    Luke Power - Chief Financial Officer, Senior Vice President, Chief Accounting Officer

  • Yes. We'll assess that at the end of the year. I definitely think we could look and see where we're at with the new launches. We feel really good about them, especially monitoring and MRD coming down the pipe. So I think as we get into next year, that's where we'll focus on okay, what are we going to guide to from the new products? Where do we feel like the therapy selection business is and kind of assess it that way.

    是的。我們會在年底時評估。我確實認為我們可以看看新產品上市的進展到哪裡。我們對它們感覺非常好,尤其是監測與 MRD 正在推進中。所以我想等到進入明年時,我們會把重點放在:新產品我們要指引到什麼程度?治療選擇(therapy selection)業務目前處於什麼狀態,並以這樣的方式來評估。

  • Daniel Brennan - Analyst

    Daniel Brennan - Analyst

  • Got it. Yeah. So basically, if there are 20 -- whatever the number is, it's going to incorporate, it will be have therapy selection plus these others in there. But will you break out therapy selection in the guide when you do it?

    了解。是的,所以基本上,如果是 20%——不管實際數字是多少——它會把治療選擇以及其他項目都納入其中。但你們在提供指引時,會把治療選擇單獨拆分出來嗎?

  • Luke Power - Chief Financial Officer, Senior Vice President, Chief Accounting Officer

    Luke Power - Chief Financial Officer, Senior Vice President, Chief Accounting Officer

  • No. I think what we'll do -- as it grows, we'll continue to assess it. But I think initially, we'll take the path that we're taking right now where it's a total clinical volume number.

    不會。我想我們會——隨著它成長,我們會持續評估。但我想一開始,我們會延續目前的做法,也就是提供一個總體的臨床量(clinical volume)數字。

  • Daniel Brennan - Analyst

    Daniel Brennan - Analyst

  • Got it. Okay. And you guys didn't give an MSEB number this quarter. I know it was asked 3 or 4 times, right? Was there a number again or now?

    了解。好。另外你們這一季沒有提供 MSEB 的數字。我知道這個問題被問了三、四次,對吧?所以現在有數字可以提供嗎?

  • Luke Power - Chief Financial Officer, Senior Vice President, Chief Accounting Officer

    Luke Power - Chief Financial Officer, Senior Vice President, Chief Accounting Officer

  • No, no.

    沒有,沒有。

  • Daniel Brennan - Analyst

    Daniel Brennan - Analyst

  • Okay, all right, guys. Thanks a lot. Appreciate it.

    好,好的,各位。非常感謝。感激不盡。

  • Operator

    Operator

  • Evie Koslosky, Goldman Sachs.

    Goldman Sachs 的 Evie Koslosky。

  • Elizabeth Koslosky - Analyst

    Elizabeth Koslosky - Analyst

  • Great. Thanks for taking my questions. So first, maybe talk through your conversations with health systems ahead of the confirmed MRD launch, maybe how much appetite is there to simplify suppliers from their perspective, given you have the full portfolio of tests and maybe also talk through the performance of the test versus peers in the face and generally how you're viewing the competitive environment?

    很好。謝謝讓我提問。首先,能否談談在 MRD 確認上市之前,你們與醫療體系(health systems)的對話情況?從他們的角度來看,鑑於你們擁有完整的檢測產品組合,他們對於簡化供應商(supplier)有多大的意願?另外,也請談談在面對同業時,你們檢測的表現如何,以及你們整體如何看待競爭環境?

  • Luke Power - Chief Financial Officer, Senior Vice President, Chief Accounting Officer

    Luke Power - Chief Financial Officer, Senior Vice President, Chief Accounting Officer

  • Yeah. Brian, do you want to take the customer focus on that --?

    是的。Brian,你要不要先從客戶端的觀點來回答——?

  • Brian Brille - Vice Chairman of the Board, Executive Vice President

    Brian Brille - Vice Chairman of the Board, Executive Vice President

  • Hey, Evie, it's Brian. Look, our institute -- we have very strong and very broad institutional and individual medical oncologist relationships that, in many respects, have anticipated the rollout of our technology whole exome 23,000 genes across a broader product line. So there's an embedded demand on the part of all of these relationships for an MRD-slash-monitoring type of solution.

    嗨,Evie,我是 Brian。你看,我們的機構——我們與機構端以及個別腫瘤內科醫師都建立了非常強且非常廣泛的關係;在很多方面,這些關係早已預期我們的技術會推出:全外顯子(whole exome)23,000 個基因,並延伸到更廣的產品線。因此,這些關係對於 MRD/監測(monitoring)類型的解決方案,本身就存在內建的需求。

  • So we expect that introduction -- I wouldn't even call it a launch. I'd say it's an introduction and provision of the Caris platform more broadly across those same institutions, same oncologists and in some cases, same patients. So I'm very excited about that.

    所以我們預期這次的導入——我甚至不會稱之為「上市」。我會說這是把 Caris 平台更廣泛地導入到同樣的機構、同樣的腫瘤科醫師,某些情況下甚至是同樣的病人身上。所以我對此非常興奮。

  • It will help us in terms of volumes. It will help us in terms of just our presentation as a strategic partner. It fits neatly into those conversations at both the senior leadership levels at the institutions as well as with the individual medical oncologists. So I'm very excited about that.

    它會在量(volumes)方面幫助我們。也會在我們作為策略合作夥伴的呈現上幫助我們。在機構的高階領導層,以及個別腫瘤內科醫師層級的對話中,它都能非常自然地融入。所以我對此非常興奮。

  • I think the differentiated technology is super exciting as well as just the completion of the continuum of care. So that's how we feel about it. And I think it's just a very natural thing for our existing sales force to have in the bag.

    我認為差異化的技術非常令人振奮,同時也代表照護連續體(continuum of care)的完整性。所以我們的感受就是如此。而且我認為,對我們既有的業務團隊來說,這是一個非常自然、可以直接放進工具袋裡的產品。

  • Now we'll probably, just like with Caris Assure, this fits within the specialty sales team for Assure, which we're continuing to build. So as part of the investment program, more FTEs within the sales force. We're also building out the specialty team. So I think that's going to be part of the strategy and investment program on the commercial side as well, all of which will, I think, be very, very helpful for a variety of things.

    不過我們可能會——就像 Caris Assure 一樣——把它放在 Assure 的專業銷售團隊(specialty sales team)之內,而我們也正在持續擴編這個團隊。所以作為投資計畫的一部分,銷售團隊會增加更多全職人力(FTE)。我們也在建立專業團隊。因此我認為,這也會是商業端策略與投資計畫的一部分;我想這些都會在很多方面帶來非常、非常大的幫助。

  • Elizabeth Koslosky - Analyst

    Elizabeth Koslosky - Analyst

  • Great. And then on Detect, I know you mentioned the advertising campaigns were really only launched in a few markets. I guess when should we expect you to get to kind of the full 100% launch of those campaigns. And then also maybe talk about the global opportunity within the tech versus more of the US opportunity and where you would expect to see the initial demand there?

    很好。接著關於 Detect,我知道你提到廣告活動其實只在少數市場推出。那我們大概什麼時候可以預期你們把這些活動推到接近 100% 的全面上線?另外也請談談,這項技術在全球市場的機會相較於美國市場的機會如何,以及你們預期初期需求會先從哪裡出現?

  • Luke Power - Chief Financial Officer, Senior Vice President, Chief Accounting Officer

    Luke Power - Chief Financial Officer, Senior Vice President, Chief Accounting Officer

  • Yeah. So I can take that, Evie. So I think what we'll do is we'll continue to be kind of assessing it as we continue to roll out and make sure we have enough capacity for running it. Again, it's a differentiated asset. And I say in its whole genome. So it's a lot of sequencing. So we'll continue to assess that from the capacity front with the rollout, and then that will little align with how we do from a marketing standpoint and continue to expand markets there and expand into partnerships there.

    好的,Evie,我可以回答這題。我想我們會在持續推進上線的同時持續評估,並確保我們有足夠的檢測執行產能。再次強調,這是一個差異化資產。而且我說的是全基因組(whole genome)。所以需要做大量定序。因此我們會在推進上線的同時,從產能角度持續評估;接著這也會與我們在行銷端的做法相互對齊,並持續擴大市場、以及擴展合作夥伴關係。

  • You're 100% right. Obviously, we're focused on the US market right now with the digital platform. we're doing. But I think there's a huge opportunity to expand. That's not in our plan right now in the next couple of quarters. We're focused on the US market, but there's definitely opportunity as we get to the end of 2027 to start considering additional strategic partners outside of the US.

    你說得完全正確。很明顯地,我們目前透過正在做的數位平台,重點放在美國市場。(我們正在進行的。)但我認為擴張的機會非常大。不過在接下來幾個季度,這不在我們目前的計畫之內。我們會先聚焦美國市場,但到了 2027 年底,確實有機會開始考慮在美國以外尋找更多策略合作夥伴。

  • Brian Brille - Vice Chairman of the Board, Executive Vice President

    Brian Brille - Vice Chairman of the Board, Executive Vice President

  • Evie, it's Brian. We've already -- we've had significant reach out from large groups outside the United States, more generally, but also as it relates to detect an MSEB. So I don't think it should be a surprise that there's strong interest in longevity, health span and MSEB as well as our technology as it relates to Caris Detect. I think the other thing worth pointing out, and we've talked a little bit about the technology and the campaigns, but the other thing that's going on that we're spending a lot of time and effort on, is building the channel.

    Evie,我是 Brian。我們已經——我們已經收到來自美國以外大型團體的顯著接洽,整體而言是如此,但也包括與 Detect 和 MSEB 相關的部分。所以,對於長壽(longevity)、健康壽命(health span)與 MSEB,以及我們與 Caris Detect 相關的技術受到高度關注,我認為這不應該令人意外。另外還有一點值得指出:我們談了一些技術與行銷活動,但我們正在投入大量時間與精力做的另一件事,是建立通路(channel)。

  • So as you know, we're not taking an individual PCP type of approach, but rather developing strategic relationships with channel partners that often have organized the PCP. So we're working with the digital platforms, Coles medicine groups, longevity companies, et cetera. And this market is scaling very rapidly, very significant membership, and they're looking for a solution.

    如你所知,我們不採取逐一面向個別基層照護醫師(PCP)的方式,而是與通路合作夥伴建立策略關係;這些合作夥伴往往已經把 PCP 組織起來。因此我們正在與數位平台、Coles 醫療集團、長壽公司等合作。

  • They're looking for the best technology. They're looking for MSEB as a part of their overall strategy and they want a better MSEB solution than what's currently available. So I think we with our early-stage sensitivity fit very neatly within that.

    他們在尋找最好的技術。他們希望把 MSEB 納入其整體策略的一部分,而且他們想要一個比目前市面上更好的 MSEB 解決方案。所以我認為,以我們在早期階段的靈敏度(early-stage sensitivity),非常自然地契合這個需求。

  • We have many conversations going on. They're all positive. And what's happening, I think, to be more specific about it is, we're developing those relationships, and we're getting onboarded, right? In many cases, they have SAPs, they have a process. So we're getting onboarded.

    我們正在進行很多對話。目前都很正面。而我認為更具體來說,正在發生的是:我們在建立這些關係,並且正在完成上線導入(onboarded),對吧?在很多情況下,他們有 SAP,他們有流程。所以我們正在完成上線導入。

  • They're very interested in the technology. So all of that is building. And I'd say there's a lot of momentum as it relates to kind of onboarding those various channel partners.

    他們對這項技術非常感興趣。所以這一切都在逐步累積。我會說,在讓各種通路合作夥伴上線這件事上,動能相當強。

  • Operator

    Operator

  • Tycho Peterson, Jefferies.

    Tycho Peterson,Jefferies。

  • Tycho Peterson - Analyst

    Tycho Peterson - Analyst

  • Hey, thanks. Thinking about Caris Assure therapy monitoring, how should we think about the attach rate with therapy selection testing? I mean is there a general rule of thumb that you're keeping in mind as you look out, is it two-to-one? How do you think about that?

    嗨,謝謝。談到 Caris Assure 的治療監測,你們認為它與治療選擇檢測的附加率(attach rate)應該怎麼看?我的意思是,你們在展望時有沒有一個大致的經驗法則,例如二比一?你們怎麼思考這件事?

  • Luke Power - Chief Financial Officer, Senior Vice President, Chief Accounting Officer

    Luke Power - Chief Financial Officer, Senior Vice President, Chief Accounting Officer

  • Yes. Brian, do you want to take that one?

    是的。Brian,你要不要回答這題?

  • Brian Brille - Vice Chairman of the Board, Executive Vice President

    Brian Brille - Vice Chairman of the Board, Executive Vice President

  • Listen, Tycho, that's a great question. We think it's going to be quite significant because it's very natural given the interest in our technology to follow through with monitoring. So I don't think we have a specific answer to that, but we think that given the initial reaction and just the logic associated with this, we think that attach rate could be quite significant.

    聽著,Tycho,這是個很好的問題。我們認為會相當可觀,因為基於大家對我們技術的興趣,後續接著做監測是非常自然的延伸。所以我不覺得我們現在有一個特定的數字答案,但我們認為,考量到初期反應以及這件事背後的邏輯,附加率可能會相當顯著。

  • Tycho Peterson - Analyst

    Tycho Peterson - Analyst

  • Okay. And then one for Luke on margins. I mean just thinking about the gives and takes here. I mean you're rolling out three tests without reimbursement out of the gate. Obviously, Detect is cash pay, but then you have the Everlywell partnership. So splitting the economics.

    好的。接著有一題想問 Luke,關於毛利率。我是在想這裡面的取捨。你們一開始就推出三項尚未取得給付(reimbursement)的檢測。顯然 Detect 是自費(cash pay),但你們也有 Everlywell 的合作。所以經濟利益要分拆。

  • Can you maybe just get us comfortable with the margin outlook. I know you don't want to talk a lot about '27, but how do we get comfortable it's not dilutive to margins significantly as you roll these out?

    你能不能讓我們對毛利率展望更安心一些?我知道你不想多談 2027 年,但當你們推出這些產品時,我們要怎麼確信它不會對毛利率造成顯著稀釋?

  • Luke Power - Chief Financial Officer, Senior Vice President, Chief Accounting Officer

    Luke Power - Chief Financial Officer, Senior Vice President, Chief Accounting Officer

  • Yes. Again, it's because of the disciplined approach we'll take, Tycho, with everything. So one of the key things that we'll continue to assess is obviously the improvement in sequencing technology, which I think will benefit. There was a question asked earlier. We're definitely seeing that play out, and we definitely think that will have a positive impact on our existing products today and on our new products as well from a sequencing cost standpoint.

    是的。Tycho,再次強調,這是因為我們對所有事情都會採取嚴謹自律的方法。所以我們會持續評估的一個關鍵點,當然是定序技術的改善,我認為這會帶來好處。先前也有人問過這個問題。我們確實看到這正在發生,而且我們確實認為,從定序成本的角度來看,這會對我們現有產品以及新產品都帶來正面影響。

  • I think the second thing, too, is, obviously, we continue to execute across the building and market access groups. And I think with our existing products itself and with obviously the increase in the 5250 rate for Caris Assure effective January 1. That will also help kind of soften the blow of launching these products without reimbursement, and that's kind of our plan is to continue to manage it smartly.

    我想第二點是,顯然我們也持續在建置與市場准入(market access)團隊上執行到位。而且我認為,就我們現有產品本身,以及 Caris Assure 自 1 月 1 日起 5250 費率的上調,這也會在某種程度上緩解在尚未取得給付的情況下推出這些產品所帶來的衝擊;我們的計畫就是持續以更聰明的方式來管理。

  • So I don't expect a massive deterioration as we go through this. And then I think, actually, we could see improvements on the sequencing technology. Obviously, if MRD is a very recurring product that you could have a lot of tests out of the gate, but we'll launch this in a smart way with select customers and continue to roll it out customer by customer rather than a broad launch initially, while we work through the reimbursement pathway. It's similar to what we're doing with monitoring, it's a similar approach.

    所以我不預期在推進過程中會出現大幅惡化。而且我認為,實際上我們可能會在定序技術上看到改善。顯然,如果 MRD 是一個高度重複性的產品,一開始就可能有大量檢測量,但我們會以聰明的方式推出:先從特定客戶開始,並且以一個客戶接一個客戶的方式逐步擴展,而不是一開始就大規模上市,同時我們也會把給付路徑(reimbursement pathway)跑順。這跟我們在做監測的方式很像,是類似的做法。

  • So again, we'll be smart about it. I don't expect massive deterioration at all that.

    所以再次強調,我們會很謹慎地做。我完全不預期會有大幅惡化。

  • Operator

    Operator

  • Paige Chamberlain, Wolfe Research.

    Paige Chamberlain,Wolfe Research。

  • Paige Chamberlain - Analyst

    Paige Chamberlain - Analyst

  • Hey, guys. Thanks for taking the question. Clearly very focused on Detect, I'm going to ask another one if you'll allow it. If I'm recalling correctly, there was a comment on the 2Q call around current revenue capacity. I think it was specific to the tech and the comment was $1 billion in revenue capacity, which out of 3,500 ASP implies something like 300,000 tests. And I wear on all of math is that volume number, anything we should be thinking of in the ballpark anytime soon.

    嗨,各位。謝謝讓我提問。你們顯然非常聚焦在 Detect,我如果可以的話再問一題。如果我沒記錯的話,你們在第二季電話會議上曾提到目前的營收產能。我記得是針對技術面,提到有 10 億美元的營收產能;以 3,500 的 ASP 來推算,大概意味著 30 萬次檢測。以我粗略的數學來看,這個量級在近期是否有任何我們應該納入考量、可能接近的情境?

  • Luke Power - Chief Financial Officer, Senior Vice President, Chief Accounting Officer

    Luke Power - Chief Financial Officer, Senior Vice President, Chief Accounting Officer

  • Yeah. I think that's where we want the capacity to be, Paige. I think that's what we're striving for. You can see that reflective in our CapEx expenditures. It's one of the key things we're focused on as we roll out, not just the Detect, but also the other products that are recurring is increasing the sequencing capacity to support that potential.

    是的,我認為那就是我們希望達到的產能水準,Paige。我想那是我們努力的方向。你可以從我們的資本支出(CapEx)看出這一點。當我們推出的不只是 Detect,還有其他具重複性(recurring)的產品時,我們聚焦的關鍵之一,就是提升定序產能來支撐那樣的潛在需求。

  • So that's something we're working towards. It's not something we have today, but that's what we're working towards over the next kind of couple of quarters and what you've seen over the past couple of quarters with our CapEx spend.

    所以這是我們正在努力達成的目標。這不是我們今天就已具備的能力,但這是我們在接下來幾個季度努力的方向,也就是你在過去幾個季度看到我們 CapEx 支出所反映的。

  • Paige Chamberlain - Analyst

    Paige Chamberlain - Analyst

  • And I'm just going to squeeze in one more on the sales force expansion. So I heard the latest number this quarter, 325. You must be liking what you're seeing because the original number, I think you guys were targeting was 300. I'd love detail on what sort of metrics you're seeing that are encouraging the continued expansion? And is 325 sort of a stopping point? Or are you guys still hiring?

    我再塞一題,關於銷售團隊擴編。所以我聽到你們這一季最新的數字是 325 人。你們一定很喜歡目前看到的成果,因為原本我記得你們的目標是 300 人。我很想了解,是哪些指標讓你們覺得值得持續擴編?325 是一個暫停點嗎?還是你們仍在招募?

  • Brian Brille - Vice Chairman of the Board, Executive Vice President

    Brian Brille - Vice Chairman of the Board, Executive Vice President

  • Yes. Yes. Pat, it's Brian. We are liking what we're seeing a lot. We have so many different things were. We think the market is very accommodating. We see a large and growing TAM with increasing adoption of precision oncology programs as well as just more profiling on the part of individual medical oncologists. Our platform overall has many different edges from technology to scale.

    是的,是的。Pat,我是 Brian。我們非常喜歡我們所看到的結果。我們有很多不同的面向在推進。我們認為市場非常有利。我們看到一個龐大且持續成長的 TAM(總可服務市場),精準腫瘤學(precision oncology)計畫的採用率在提升,同時個別腫瘤內科醫師也在做更多的檢測剖析(profiling)。我們的平台整體在技術到規模上都有很多優勢。

  • I think our channel itself with all the relationships is a huge competitive edge for us. But as you know, the FTEs had drifted down there for a while, right, before the IPO. So we're continuing to build in, and we're seeing a real ROI associated with that. And we don't see any end in sight for that. So we're going to continue to hire.

    我認為我們的通路本身以及所有合作關係,對我們來說是一個巨大的競爭優勢。但如你所知,在 IPO 之前,那段時間 FTE 人數曾經下滑,對吧?所以我們正在持續補強,而我們也看到與此相關的實質投資報酬(ROI)。而且我們看不到這件事有任何要停下來的跡象。所以我們會繼續招募。

  • Our Chief Commercial Officer is organized. We're going to expand the number of territories. We'll expand the number of FTEs. We see the opportunity in the market for Assure, it's only growing, and we think we have significant number of edges so that we don't see any reason to not continue to put the various pieces in place to provide the technology to more institutions and more oncologists.

    我們的商務長(Chief Commercial Officer)已經把組織架構整理好。我們會擴大區域數量(territories)。我們也會增加 FTE 人數。我們看到 Assure 在市場上的機會只會持續成長,而且我們認為自己有相當多的優勢,因此我們看不出有任何理由不持續把各個環節到位,將技術提供給更多機構與更多腫瘤科醫師。

  • Operator

    Operator

  • Jack Meehan, Nephron Research.

    Jack Meehan,Nephron Research。

  • Jack Meehan - Equity Analyst

    Jack Meehan - Equity Analyst

  • Thanks, appreciate it guys. I wanted to ask about the volume question in a different way. Maybe in that 61,500 tests that you reported, is it possible to tease out what non-therapy selection contribution there was? And the reason I ask is I'm building off Dan Brennan's question earlier, just looking at the sequential step-up in 4Q. I assume that is expanding. So just getting a little color on how that is trending would be really helpful.

    謝謝,感謝各位。我想用不同方式問一下量的問題。在你們報告的 61,500 次檢測中,是否有可能拆解出其中非治療選擇(non-therapy selection)的貢獻?我之所以這樣問,是因為我在延伸 Dan Brennan 先前的問題,觀察第四季的季增幅度;我假設那部分正在擴大。所以如果能提供一些趨勢上的補充說明,會非常有幫助。

  • Luke Power - Chief Financial Officer, Senior Vice President, Chief Accounting Officer

    Luke Power - Chief Financial Officer, Senior Vice President, Chief Accounting Officer

  • Yeah. Jack, so if you take -- like that's the reason why we commented on the mix trend from the first couple of quarters, it's consistent with that trend, what you saw from Q1 to Q2 and then following all the way to Q3, and we expect that trend to continue into Q4.

    是的。Jack,所以如果你看——這也是為什麼我們會評論前幾季的組合(mix)趨勢;它與那個趨勢一致,也就是你從 Q1 到 Q2 看到的,然後一路延續到 Q3,而我們預期這個趨勢會在 Q4 持續。

  • Jack Meehan - Equity Analyst

    Jack Meehan - Equity Analyst

  • Okay. And then as an unrelated follow-up, I did want to ask you about the supplies on the balance sheet. Obviously, you did some stocking last quarter. It looks like you did more stocking this quarter. The inventory kind of weeks on hand is elevated. I was curious, maybe just your philosophy around stocking why you're doing this and whether you think that could be a source of cash at some point?

    好的。接著作為一個不相關的追問,我想請教一下資產負債表上的供應品。很明顯,你們上季做了一些備貨。看起來這一季你們備貨更多。庫存的在手週數偏高。我想了解一下,你們對備貨的理念是什麼、為什麼要這麼做,以及你們是否認為這在某個時間點可能會成為現金來源?

  • Luke Power - Chief Financial Officer, Senior Vice President, Chief Accounting Officer

    Luke Power - Chief Financial Officer, Senior Vice President, Chief Accounting Officer

  • Yes. Yes. Again, it's ahead of the launches. One of the key things is obviously with the tech launch, we got prepared. But the other thing, too, is these are the same kits that we're going to run for Achieve 2 samples, which we started to run -- that's kind of a key focus for us in Q4 to get that interim readout as quickly as possible.

    是的。是的。再說一次,這是為了上市前的準備。其中一個關鍵點當然是,隨著技術產品上市,我們已經做好準備。但另外一點是,這些也是我們將用於 Achieve 2 樣本的同一套試劑盒;我們已經開始進行——這也是我們在第四季的一個重點,盡快取得該期中讀出。

  • And then also with the new Assure launch as well, that's on the NovaX platform as well. So I think what you saw this quarter with the inventory is just kind of a general step up. It's kind of consistent with what we've done before that big ramp-up in Q2. And yes, we paid down, obviously, quite a bit of it, and you can see that reflected in the accounts payable. That dropped close to $38 million, and that was on purpose.

    另外,新的 Assure 上市也一樣,它同樣是在 NovaX 平台上。所以我認為你們這一季在庫存上看到的,只是整體水位的一般性上升。這與我們過去在第二季大幅拉升之前所做的做法一致。而且是的,我們也很明顯地償付/降低了其中相當一部分,你們可以在應付帳款中看到反映。應付帳款下降了接近 3,800 萬美元,這是刻意為之。

  • So that's why we feel very confident about being positive free cash flow again. We don't expect to do that around at the end of the year.

    所以這也是為什麼我們對再次實現正的自由現金流非常有信心。我們不預期在年底還會再做那樣的操作。

  • Operator

    Operator

  • Kyle Mikson, Canaccord.

    Kyle Mikson,Canaccord。

  • Alexander Vukasin - Analyst

    Alexander Vukasin - Analyst

  • This is Alex Vukasin. I'm on for Kyle Mikson. Congratulations on the quarter and recent launches. So just circling back to the first question for Q&A. Understanding you aim to provide less granular tails going forward.

    我是 Alex Vukasin。我代替 Kyle Mikson 參與。恭喜本季表現以及近期的產品上市。我想回到問答一開始的第一個問題。理解你們未來打算提供較不細的拆分資訊。

  • One of the key factors that we continue to monitor going into next year is the tissue therapy selection test volume expansion. So you stated in the prepared remarks, fit flagship opportunity and enrich. Is what gives you confidence to continue to expand the base tissue as sort of going forward? Could it take additional commercial investment.

    我們在展望明年時持續關注的一個關鍵因素,是組織(tissue)治療選擇檢測量的擴張。你們在事先準備的講稿中提到,契合旗艦機會並加以強化(enrich)。是什麼讓你們有信心,能在未來持續擴大組織端的基礎?是否需要額外的商業化投資?

  • And it's made double-digit year-over-year test line expansion, sustainable for the blood side of the detection business in the near to the interim? Or could we perhaps see a bit of a slowdown.

    另外,檢測業務中血液端在短期到中期維持年對年雙位數的檢測量成長,是否可持續?或者我們可能會看到一些放緩?

  • Luke Power - Chief Financial Officer, Senior Vice President, Chief Accounting Officer

    Luke Power - Chief Financial Officer, Senior Vice President, Chief Accounting Officer

  • I think like what we've shown is obviously the acceleration, and that was in our comments, the acceleration across both from Q2. So that was positive and tissue was obviously accelerating too, which is kind of our expectation with the investment that we're doing, but with the reorganization and the realignment.

    我認為我們所展現的,顯然是加速成長,而這也在我們的評論中提到——從第二季到第三季,兩邊都在加速。所以這是正面的;而組織端也確實在加速,這符合我們對於所做投資的預期,同時也得益於重組與重新對齊。

  • So definitely the tissue will continue to improve until the end of the year. I definitely think it can continue to improve going into next year based on what we're seeing. I think from an overall standpoint, blood is obviously growing at a faster rate. It's starting from a smaller base. but we're continuing to see that growth and accelerate it in Q3 from Q2. So again, that's a testament to the work of the sales team. I think we'll continue to add to the sales team.

    因此,組織端在年底前肯定會持續改善。基於我們目前看到的情況,我也確實認為進入明年仍可持續改善。從整體來看,血液端顯然以更快的速度成長。它是從較小的基礎起步。但我們持續看到那樣的成長,且在第三季相較第二季有所加速。所以再次證明銷售團隊的工作成效。我認為我們也會持續擴編銷售團隊。

  • As Brian mentioned, we're not going to stop with the $325 million, we're going to keep adding based on what we're seeing from the inbound and from the orders and from the penetration in the institutions. So we feel great about both going forward. But we won't be disclosing a growth rate for each of those individually. It will be on a total basis.

    如 Brian 所提到的,我們不會在 3.25 億美元就停下來;我們會根據我們從主動洽詢(inbound)、訂單,以及在機構端滲透率所看到的情況持續增加。所以我們對兩者的未來都感到非常樂觀。但我們不會分別揭露各自的成長率。我們會以總體口徑來揭露。

  • Alexander Vukasin - Analyst

    Alexander Vukasin - Analyst

  • And so you've obviously been able to achieve a lot of innovation internally. Yes, it's important to note that you maintain substantial cash position, which provides you with optionality. Could you elaborate on your M&A mandate or criteria. And generally, if you're open to acquire technology externally to either boost current offerings, perhaps planned offerings for launch or launch products available commercially for competitive reasons or just to expand the test menu.

    另外,你們顯然已經在內部實現了很多創新。同時也很重要的一點是,你們維持了可觀的現金部位,這讓你們有更多選擇性。能否談談你們的併購(M&A)授權範圍或評估標準?以及更一般性地說,你們是否願意透過外部收購技術,來強化現有產品、或強化計畫上市的產品,或是出於競爭考量收購已商業化上市的產品,或只是為了擴充檢測選單?

  • Luke Power - Chief Financial Officer, Senior Vice President, Chief Accounting Officer

    Luke Power - Chief Financial Officer, Senior Vice President, Chief Accounting Officer

  • Yes. Go ahead, Brian.

    是的。Brian,你先請。

  • Brian Brille - Vice Chairman of the Board, Executive Vice President

    Brian Brille - Vice Chairman of the Board, Executive Vice President

  • I was just going to say, look, this market has grown, and it's definitely consolidating. So there's more M&A, which I think is healthy because a number of these companies without a commercial channel really need to fight a home. They have no real viability on a stand-alone basis. So there's plenty of opportunity. We have not used it as a tactic for a whole variety of reasons, including the fact that we haven't seen anything that we thought would be incrementally helpful to us from a -- particularly from a technology perspective.

    我只是想說,你看,這個市場已經成長,而且確實正在整併。所以併購活動更多了;我認為這是健康的,因為其中不少公司沒有商業通路,確實需要找到歸宿。它們若以獨立公司存在,並沒有真正的可行性。所以機會很多。但我們基於各種原因,並沒有把併購當作策略手段,其中包括:我們尚未看到任何我們認為能對我們帶來增量幫助的標的——尤其是在技術層面。

  • So our founder here is always focused on developing and pioneering this market and creating the best technology. And I think we're going to continue to do that. So with that mentality and with our leadership position with respect to technology, it's just hard to find things that would be incrementally useful. And that is despite the fact that we have a skill set here, starting with David's experience and building companies through M&A. So there's certainly no reluctance or lack of capability, it's simply just opportunistically, we think we're better off devoting our time resources, attention to an organic building strategy.

    因此,我們的創辦人一直專注於開發並引領這個市場,打造最好的技術。我想我們會持續這麼做。在這樣的心態下,加上我們在技術方面的領先地位,要找到能帶來增量效益的東西其實很難。這點即便在我們具備相關能力的情況下仍然成立——從 David 的經驗開始,他曾透過併購打造公司。所以我們並非不願意或缺乏能力;只是從機會角度來看,我們認為把時間、資源與注意力投入到有機成長的建構策略上更划算。

  • But it's a possibility. And if something comes up that's relevant, we're certainly capable both with respect to our own human capital as well as our financial capital.

    但這仍然是一種可能性。如果出現相關的機會,我們當然有能力,不論是我們自身的人才資本,或是財務資本。

  • Alexander Vukasin - Analyst

    Alexander Vukasin - Analyst

  • Great. Thank you.

    很好。謝謝。

  • Operator

    Operator

  • And this does conclude today's conference call. Thank you so much for joining. You may now disconnect.

    今天的電話會議到此結束。非常感謝各位參與。您現在可以掛線。