Caris Life Sciences, Inc. (CAI) 2025 Q4 法說會逐字稿

Good afternoon, everyone, and welcome to the Caris Life Sciences Q4 2025 earnings call. My name is Dana, and I will be your coordinator today. (Operator Instructions) Please be advised that today's conference is being recorded.

各位下午好，歡迎參加 Caris Life Sciences 2025 年第四季財報電話會議。我叫達娜，今天我將擔任你們的協調員。（操作人員指示）請注意，今天的會議正在錄音。

I would now like to hand the conference over to your first speaker, Russ Denton. Please go ahead.

現在我謹將會議交給第一位發言人，拉斯·丹頓。請繼續。

Thank you. Earlier today, Caris Life Sciences released financial results for the quarter and year ended December 31, 2025. Joining the call from Caris today are David Dean Halbert, our Founder, Chairman and CEO; David Spetzler, our President; Brian Brille, our Vice Chairman and EVP; Bobby Hill, our Chief Commercial Officer; and Luke Power, our CFO.

謝謝。今天早些時候，Caris Life Sciences 發布了截至 2025 年 12 月 31 日的季度和年度財務表現。今天參加 Caris 會議的有：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；首席商務官 Bobby Hill；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 involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated. These risks are discussed in our SEC filings, including our quarterly reports on Form 10-Q and our annual report on Form 10-K to be filed with the SEC.

在開始之前，我想提醒各位，在本次電話會議中，管理層將根據聯邦證券法做出前瞻性陳述。這些聲明涉及重大風險和不確定性，可能導致實際結果或事件與預期結果或事件有重大差異。這些風險已在我們的美國證券交易委員會文件中進行了討論，包括我們向美國證券交易委員會提交的 10-Q 表格季度報告和 10-K 表格年度報告。

Assessed as required by law, Caris disclaims any intention or obligation to update or revise financial projections and forward-looking statements whether because of new information, future events or otherwise. The information discussed in this conference call is accurate only as of the live broadcast. This call will also include a discussion of non-GAAP financial measures, which are adjusted to exclude certain specified items. A reconciliation of these non-GAAP financial measures to the most directly comparable GAAP financial measures are available in the press release Caris issued today. A copy of today's presentation materials along with an interim readout of our Q1 study can be found on our website.

根據法律規定，Caris 聲明不承擔任何更新或修改財務預測和前瞻性聲明的意圖或義務，無論是因為新資訊、未來事件或其他原因。本次電話會議中討論的資訊僅在直播時有效。本次電話會議也將討論非GAAP財務指標，這些指標經過調整，排除了某些特定項目。Caris今天發布的新聞稿中提供了這些非GAAP財務指標與最直接可比較的GAAP財務指標的調節表。您可以在我們的網站上找到今天的演示材料副本以及我們第一季研究的初步結果。

I will now turn the call over to Brian.

現在我將把通話轉給布萊恩。

Thanks, Russ, and thank you all for joining our fourth quarter 2025 earnings call. This is our first year-end call as a public company following our June IPO last year, and we're pleased to report another record-breaking quarter, finishing the year with excellent performance across the company in terms of growth and underlying financial strength.

謝謝 Russ，也謝謝各位參加我們 2025 年第四季財報電話會議。這是我們自去年 6 月上市以來首次作為上市公司召開的年終電話會議，我們很高興地宣布又一個破紀錄的季度，公司在增長和基本財務實力方面都取得了優異的業績，為這一年畫上了圓滿的句號。

I want to start with what has always mattered most at Caris, our mission. Caris was founded to make precision medicine a reality. We aim to fundamentally change the way disease is characterized and treated. We believe more information is more power and every patient deserves more power in the battle against disease. That mission is being powered by a molecular platform, which benefits from scale and highly differentiated capabilities as illustrated on slide 3.

我想先談談卡里斯一直以來最重視的事情——我們的使命。Caris 的創立宗旨是讓精準醫療成為現實。我們的目標是從根本上改變疾病的特徵描述和治療方式。我們相信，掌握更多資訊就是擁有更大的力量，每位患者都應該在與疾病的鬥爭中擁有更大的力量。該任務由分子平台驅動，該平台受益於規模和高度差異化的能力，如幻燈片 3 所示。

Our platform continues to scale. And in 2025, we completed just under 200,000 individual cases. With this clinical activity, we have recently reached a platform milestone as our molecular data set now exceeds over 1 million profiled cases and has grown into one of the most important clinical genomic resources in the industry.

我們的平台持續擴展。到 2025 年，我們完成了近 20 萬個案。憑藉這項臨床活動，我們最近達到了一個平台里程碑，因為我們的分子數據集現在已經超過 100 萬個分析病例，並已發展成為業內最重要的臨床基因組資源之一。

As the industry evolves, the intersection of molecular science and AI is accelerating technological innovation. Our philosophy is a long-term strategic orientation to develop the best offerings on the market and to pursue this innovation while generating profitable growth and maintaining financial strength.

隨著產業的不斷發展，分子科學與人工智慧的交叉融合正在加速技術創新。我們的理念是採取長期策略導向，開發市場上最好的產品，並在追求創新的同時實現獲利成長並保持財務實力。

We've had an outstanding fourth quarter with total revenues increasing 125% year over year to $293 million. As demonstrated on slide 4, this result was driven primarily by strong performance from clinical profiling. Molecular profiling services revenues increased to $282 million in the fourth quarter representing an increase of 199% year over year.

我們第四季業績非常出色，總營收年增 125%，達到 2.93 億美元。如投影片 4 所示，此結果主要得益於臨床分析的優異表現。第四季分子分析服務營收增至 2.82 億美元，年增 199%。

Pharma R&D Services revenues were $10.8 million in the fourth quarter, and we're making important progress in CDX data discovery, including the December announcement of the Genentech Discovery deal as well as a CDX collaboration.

第四季醫藥研發服務收入為 1,080 萬美元，我們在 CDX 資料發現方面取得了重要進展，包括 12 月宣布的 Genentech Discovery 交易以及 CDX 合作。

In summary, across the board, we had a very productive fourth quarter illustrated by the quarter highlights on slide 5. The strong revenue performance, combined with the operating leverage inherent in our business model has produced excellent financial results, including the following: revenue growth of 125% and which was driven by volume growth of 20% and a 150% increase in clinical ASP. This revenue growth has led to significantly improved gross margins of 75% on a GAAP basis, up from 54% in the fourth quarter of 2024. It also represents a significant sequential increase from the 68% in the third quarter.

總而言之，第四季整體成果豐碩，詳情請見投影片 5 的季度亮點。強勁的收入表現，加上我們商業模式中固有的營運槓桿作用，帶來了優異的財務業績，其中包括：收入增長 125%，這主要得益於銷量增長 20% 和臨床平均售價增長 150%。營收成長使得毛利率（以美國通用會計準則計算）大幅提高至 75%，高於 2024 年第四季的 54%。與第三季的 68% 相比，這是一個顯著的環比增長。

With this gross margin improvement this quarter, we generated positive GAAP net income of $82 million and adjusted EBITDA of $106 million as well as positive free cash flow of $39.7 million. This is our third straight quarter of positive adjusted EBITDA and positive free cash flow. This strong profitability profile is unique in our industry and provides valuable strategic flexibility for ongoing investment in our tech platform for new products as well as the ability to develop new channels such as (inaudible). In addition, our balance sheet continues to strengthen with cash on hand growing to slightly above $800 million, an increase of $43 million in the quarter. The Caris data set has continued to grow with our clinical profiling activity and now exceeds 1 million genomic profiles and 740,000 match profiles.

由於本季毛利率的提高，我們實現了 8,200 萬美元的 GAAP 淨利潤和 1.06 億美元的調整後 EBITDA，以及 3,970 萬美元的自由現金流。這是我們連續第三個季度實現調整後 EBITDA 為正值和自由現金流為正值。這種強勁的獲利能力在業界獨樹一幟，為我們持續投資技術平台開發新產品以及拓展新管道提供了寶貴的策略靈活性，例如：（聽不清楚）此外，我們的資產負債表持續增強，現金儲備略高於 8 億美元，比本季增加了 4,300 萬美元。隨著我們臨床分析活動的開展，Caris 資料集持續成長，現在已超過 100 萬個基因組圖譜和 74 萬個匹配圖譜。

Since every profile has been generated with our WTS technology for many years, our data set now features 627,000 exomes and 678,000 transcriptomes. This gives our data set tremendous power for internal product development as well as attractiveness as a research partner for academic medical centers through the POA as well as for biopharma.

由於多年來我們一直使用 WTS 技術生成每個配置文件，因此我們的資料集現在包含 627,000 個外顯子組和 678,000 個轉錄組。這使得我們的數據集在內部產品開發方面具有巨大的優勢，並且透過 POA 對學術醫療中心和生物製藥公司來說，也具有很強的研究吸引力。

As the results demonstrate, our financial performance gives us unique strategic flexibility, and we intend to use that edge in 2026 to make significant investments in both the early detection business and our therapy selection channel. In early detection, we expect to realize the long-standing vision of our CEO, David Halbert, of launching a revolutionary cancer early detection test. Caris detect has the potential to bend the cancer mortality curve and ultimately make cancer a curable disease.

結果顯示，我們的財務表現賦予了我們獨特的策略靈活性，我們計劃在 2026 年利用這一優勢，對早期檢測業務和治療選擇管道進行重大投資。在早期檢測方面，我們希望實現執行長大衛哈爾伯特長期以來的願景，即推出一項革命性的癌症早期檢測測試。Caris檢測技術有可能扭轉癌症死亡率曲線，並最終使癌症成為一種可治癒的疾病。

We believe that the implications for this test are truly profound both for Caris and for our society. In our core therapy selection business, we plan to invest in our commercial channel to broaden our reach and deepen our relationships to accelerate growth. We have a new Chief Commercial Officer Bobby Hill, who took on this responsibility in the fourth quarter. We're extremely excited about the opportunities we face and the new initiatives that Bobby is driving, ranging from the expansion of the sales force and territories to enhance programming and education. Finally, we will make these investments while maintaining positive adjusted EBITDA and free cash flow.

我們認為，這項測試對 Caris 和我們的社會都具有非常深遠的意義。在我們的核心治療選擇業務中，我們計劃投資於我們的商業管道，以擴大我們的覆蓋範圍並深化我們的關係，從而加速成長。我們新任首席商務官是鮑比·希爾，他於第四季上任。我們對面臨的機會以及鮑比正在推動的新舉措感到非常興奮，這些舉措包括擴大銷售隊伍和銷售區域，以及加強項目和教育。最後，我們將在保持正調整後 EBITDA 和自由現金流的同時進行這些投資。

Our strategy is to maintain financial discipline through a strong balance sheet and profitability, and these financial pillars of strength will allow us to realize our mission of making precision medicine a reality to benefit patients and physicians. I will now turn the presentation over to Bobby Hill to provide an update on our commercial business and related strategic initiatives. Bobby?

我們的策略是透過穩健的資產負債表和獲利能力來維持財務紀律，這些財務支柱將使我們能夠實現精準醫療的使命，造福病患和醫生。現在我將把演講交給鮑比·希爾，讓他介紹我們商業業務及相關策略舉措的最新情況。鮑比？

Thanks, Brian. I will provide a brief update on our molecular profiling business along with our initiatives for the commercial teams in 2026. Starting on slide 6, this shows our strong molecular profiling revenues performance for the full year, with revenues increasing 120% to $766.7 million. This excellent revenue growth was driven by a 22% year-over-year growth in clinical case volumes to approximately 199,300 profiles and a 79% increase in average sales price, reflecting our market access and billing team's strong execution throughout 2025.

謝謝你，布萊恩。我將簡要介紹我們的分子分析業務以及我們在 2026 年為商業團隊制定的計劃。從第 6 張投影片開始，這顯示了我們全年強勁的分子分析收入表現，營收成長了 120%，達到 7.667 億美元。這一優異的收入成長得益於臨床病例量年增 22% 至約 199,300 個病例，以及平均銷售價格上漲 79%，這反映了我們市場准入和計費團隊在 2025 年的出色執行力。

This ASP growth was driven by our successful launch of My Cancer Seek on January 1 of last year, and these benefits are reflected on the slide, where tissue ASP increased by 83% to over $4,000 and our blood ASP increased by 69% and to just under $2,800 driven by billing our new PLA code and improvement payment for Caris Assure.

這次平均銷售價格 (ASP) 的成長得益於我們去年 1 月 1 日成功推出的 My Cancer Seek，這些收益反映在幻燈片中，其中組織平均銷售價格增長了 83%，超過 4,000 美元，血液平均銷售價格增長了 69%，略低於 2,800 美元，這得益於我們新的 PLA 的付款以及 Assure Assure 的付款。

Luke will discuss the breakdown of this further during the financial update, along with the trends we saw play out during 2025. This illustrates the growth that our sales team has generated in clinical profiling this year, which I am encouraged about as we see progress into 2026 already. Our Q4 growth was 20%, which was sequential improvement from 18% in Q3 '25, with Caris Assure delivering 59% year-over-year growth in Q4 '25 and continuing to gain traction.

盧克將在財務更新中進一步討論這一細分情況，以及我們在 2025 年看到的趨勢。這說明我們的銷售團隊今年在臨床分析方面取得了成長，我對此感到鼓舞，因為我們已經看到了2026年的進展。我們第四季的成長率為 20%，比 2025 年第三季的 18% 有所提高，其中 Caris Assure 在 2025 年第四季實現了 59% 的同比成長，並繼續保持成長勢頭。

Entering 2026, in order to broaden our reach and deepen our relationships to accelerate growth, we are making a continued investment in our commercial channel, by expanding the sales force, including expanding our liquid specialist team to ensure we are maximizing the impact of our excellent teams.

進入 2026 年，為了擴大我們的影響力並深化我們的關係以加速成長，我們將繼續投資於我們的商業管道，擴大銷售隊伍，包括擴大我們的液體專家團隊，以確保我們最大限度地發揮我們優秀團隊的影響。

Next, strengthening our product and value proposition messaging by focusing on key differentiation of our technology and the clinical impact, the advanced technology has on patient care, as evidenced by data publication, scientific literature, and enhancing our -- and elevating medical education and training across not just the customers we serve, but also our internal teams.

接下來，我們將透過重點突出我們技術的關鍵差異化以及先進技術對患者護理的臨床影響，來加強我們的產品和價值主張訊息，這可以透過數據發布、科學文獻來證明。此外，我們還將提升我們的醫學教育和培訓水平，不僅針對我們服務的客戶，也針對我們內部的團隊。

Since we are now also consistently reaching over 6,000 oncologists across the country and have EHR integrations of approximately 3,100 clinical sites where approximately 75% of our orders come in electronically. This will be another area that we continue to invest from a customer and team standpoint to make ordering process more streamlined. I joined Caris because of our science and technology differentiation and forward-thinking development of solutions, and I'm excited about continuing to expand the Caris commercial reach to help more patients as we go through 2026.

由於我們現在也持續與全國 6000 多名腫瘤科醫生保持聯繫，並且與大約 3100 個臨床場所實現了 EHR 集成，其中大約 75% 的訂單是通過電子方式提交的。這將是我們從客戶和團隊的角度繼續投入的另一個領域，以使訂購流程更加精簡。我加入 Caris 是因為我們在科學技術方面的優勢以及前瞻性的解決方案開發，我很高興能夠繼續擴大 Caris 的商業影響力，幫助更多患者度過 2026 年。

I will now turn the presentation over to Dr. Spetzler to discuss our progress on our product pipeline, in particular, around Caris Detect. Spetz?

現在我將把演講交給 Spetzler 博士，讓他討論我們在產品研發方面的進展，特別是 Caris Detect 的相關進展。斯佩茨？

Thanks, Bobby. So getting to our achieved on interim results that we wanted to share today and are reflected on slide 8. As you are aware, this study is for supporting the upcoming launch of Caris Detect, our whole genome sequencing based MSAD blood test in Q2 of 2026. Achieve 1 matters not just because it's following our philosophy to always put the patient first, which includes not limiting our development decisions based on cost, but to strive to pursue to the full extent possible the very best performing test.

謝謝你，鮑比。因此，我們今天想和大家分享我們在中期所取得的成果，這些成果反映在第 8 張投影片中。如您所知，這項研究是為了支持我們即將於 2026 年第二季推出的 Caris Detect，這是一款基於全基因組定序的 MSAD 血液檢測產品。實現 1 之所以重要，不僅是因為它遵循了我們始終將患者放在首位的理念，包括不根據成本限制我們的研發決策，而且還要努力追求盡可能最好的測試性能。

This has been successful for us with our therapy selection assays, which are the most comprehensive on the market, where we run whole exome and whole transcriptome sequencing on every eligible patient sample and we are again pursuing the same path in early detection.

我們的治療選擇檢測方法取得了成功，這是市場上最全面的檢測方法，我們對每個符合條件的患者樣本進行全外顯子組和全轉錄組測序，我們正在早期檢測方面再次走同樣的道路。

The interim readout reflects the benefits of that approach where we are sequencing at incredible depth across the whole genome. Our hypothesis is that cancer is fundamentally driven by molecular abnormalities and these abnormalities show up in multiple waves, driver mutations, epigenomic changes, transcriptomic changes and [Antapite]. Many approaches in blood-based early detection have leaned heavily on epigenomics alone.

中期結果反映了該方法的優勢，即我們對整個基因組進行深度定序。我們的假設是，癌症的根本驅動力是分子異常，這些異常以多波形式出現，包括驅動突變、表觀基因組變化、轉錄組變化等。[蟻丘]許多基於血液的早期檢測方法都嚴重依賴表觀基因組學。

We took a broader biological view by using ultra deep whole genome sequencing to capture as many genomic alterations as possible. That richer signal set is what we believe is driving our performance and it reinforces our view that relying on a limited slice of biology is not sufficient to reflect the diversity of cancer.

我們採用更廣泛的生物學視角，利用超深度全基因組定序來捕捉盡可能多的基因組變化。我們認為，正是這種更豐富的訊號集推動了我們的表現，也強化了我們的觀點，即僅依靠有限的生物學知識不足以反映癌症的多樣性。

What's also different about Caris Detect is the foundation it's built on. The test leverages Caris molecular profiling data sets, which, as Brian mentioned, has now surpassed 1 million cases and includes more than 50 billion molecular markers. That scale and depth allowed our AI models to identify subtle biological signals associated with early-stage cancers with a very high resolution utilizing the whole genome. As shown on the slide, the interim readout includes 2,122 total samples, 617 cancers, spanning Stages 1 through 4, and 1,505 patients with no known cancer at the time of the blood draw, a key point on the normal cohort.

Caris Detect 的另一個不同之處在於它所基於的基礎架構。該測試利用了 Caris 分子譜數據集，正如 Brian 所提到的，該數據集現在已經超過 100 萬個病例，包含超過 500 億個分子標記。這種規模和深度使得我們的人工智慧模型能夠利用整個基因組，以非常高的分辨率識別與早期癌症相關的細微生物訊號。如幻燈片所示，中期讀數包括總共 2,122 個樣本，617 例癌症（涵蓋 1 期至 4 期），以及 1,505 名在抽血時未發現癌症的患者，這是正常隊列的關鍵點。

These control samples come from individuals who had screening or symptomatic screen, which is a higher likelihood population than the general population. We have at least one year of follow-up data on 22.5% of the normals, of which 35% we identified as our asymptomatic screening population, 121 individuals with no significant risk factors for cancer and at least one year of follow-up after the blood draw. Of note, in the total cohort, 7% of patients had a subsequent diagnosis of cancer, reflecting that the control population is truly high risk.

這些對照樣本來自接受篩檢或症狀篩檢的個體，而該族群的患病可能性高於一般人。我們對 22.5% 的正常人群進行了至少一年的隨訪數據，其中 35% 被我們確定為無症狀篩檢人群，即 121 名沒有明顯癌症風險因素的個體，他們在抽血後至少進行了一年的隨訪。值得注意的是，在整個族群中，7% 的患者隨後被診斷出罹患癌症，反映出對照組確實是高風險族群。

Now to the results. From the interim readout, we observed strong sensitivity that increases with stage and high specificity. Sensitivity by stage was 56.8% on Stage 1 with 266 patients, 70.1% in Stage 2 with 137 patients, 77% in Stage 3 with 105 patients and 99.1% in Stage 4 with 109 patients. For Stage 1 and 2 combined, Achieve 1 reported 63.1% sensitivity. We also evaluated Stage 1 and 2 sensitivity by lineage across a number of cancers.

現在公佈結果。從中期結果來看，我們觀察到隨著分期增加而增強的強敏感性和高特異性。以分期計算，第 1 期（266 位患者）的敏感度為 56.8%，第 2 期（137 位患者）為 70.1%，第 3 期（105 位患者）為 77%，第 4 期（109 位患者）為 99.1%。合併為 1 階段和 2 階段，Achieve 1 報告的靈敏度為 63.1%。我們也評估了多種癌症中不同譜系的 1 期和 2 期敏感性。

Selected examples include and are included on slide 9, with breast cancer being 53% sensitive across 253 patients; valve having 62.2% sensitivity with 45 patients, prostate, 78.9% with 38 patients, uterus, 73.7% with 19 patients, lung 86.7 with 15 patients, pancreas, 71.4 with 7 patients and head and neck cancer at 100% with 7 patients.

選定的例子包括（並包含在幻燈片 9 中），乳腺癌在 253 名患者中的敏感性為 53%；瓣膜癌在 45 名患者中的敏感性為 62.2%；前列腺癌在 38 名患者中的敏感性為 78.9%；子宮癌在 19 名患者中的敏感性為 73.7%；名患者中的敏感性為 71.4%；頭頸癌在 7 名患者中的敏感性為 100%。

On specificity in which we followed 22.5% of patients for approximately three years following their blood draw, we've demonstrated the following: 99.1% specificity in the screening population with an equal 121 which we have follow-up data on these subjects that had no symptoms of cancer, no history of cancer, and no family history of cancer, and were not subsequently diagnosed with cancer within two years following the blood drop, 95.3% specificity in the higher-risk normal population with 1,505 patients, of which 600 undiagnosed subjects with at least two years of follow-up, roughly 7% of patients were subsequently diagnosed with cancer, indicating our enrollment criteria enrich for high-risk subjects.

在特異性方面，我們對 22.5% 的患者進行了大約三年的隨訪，結果如下：在篩檢人群中，特異性為 99.1%，其中 121 名受試者有隨訪數據，他們沒有癌症症狀、沒有癌症病史、沒有癌症家族史，並且在採血後兩年內未被診斷出癌症；在高危正常人群中，特異性為 95.3%名未確診的受試者至少有兩年的追蹤數據，約 7% 的患者隨後被診斷出癌症，這表明我們的入組標準有利於高風險族群。

Overall, our model performance measured by AUC was 0.90. These are interim results, which we are extremely excited about. Achieve 1 also includes a blinded holdout validation cohort of approximately 865 samples that were held out for independent testing. That blinded validation is currently in process, and we expect to support these results in Q1. In parallel, we have also begun processing samples from Achieve 2, which is the next step in the program.

整體而言，我們模型的表現（以 AUC 衡量）為 0.90。這些是中期結果，我們對此感到非常興奮。Achieve 1 還包括一個盲法保留驗證隊列，其中約有 865 個樣本被保留下來進行獨立測試。目前盲測驗證正在進行中，我們預計將在第一季證實這些結果。同時，我們也開始處理 Achieve 2 的樣本，這是該計劃的下一步。

So to summarize, Achieve 1 interim results show strong performance, including Stage 1, 2 sensitivity of 63.1%, high specificity and an AUC of 0.9 across a large data set spanning 35 cancer types and with no cancer types with help from the results. We view this as a meaningful milestone as we move forward with the blinded holdout readout as the next key catalyst.

總而言之，Achieve 1 的中期結果顯示出強勁的性能，包括 1 階段和 2 階段的靈敏度為 63.1%，特異性高，在涵蓋 35 種癌症類型的大型數據集上 AUC 為 0.9，並且沒有癌症類型借助結果得到改善。我們認為這是一個重要的里程碑，因為我們將以盲法保留試驗結果作為下一個關鍵催化劑繼續前進。

Moving to slide 10. This also reflects the status of our robust pipeline, and I'll touch on these before letting Luke wrap things up with the financials.

切換到第10張投影片。這也反映了我們強大的產品線現狀，在盧克總結財務狀況之前，我將簡要介紹這些內容。

First, Caris ChromoSeq is our whole genome plus full transcriptome offering focused on therapy selection in hematological malignancies, particularly AML, MDS, and MP and select cases of suspected myeloid malignancies where cytopenias persist and other cases have been ruled out. Similar to what I've discussed with detection, what matters here is depth and breadth. We're running greater than 200x coverage across the whole genome sequencing and the assay is designed to detect the full range of clinically relevant genomic alterations, mutations, fusions, copy number changes, expression employing with roughly 1.6 billion reads per patient.

首先，Caris ChromoSeq 是我們提供的全基因組加全轉錄組定序服務，專注於血液系統惡性腫瘤的治療選擇，特別是 AML、MDS 和 MP，以及疑似髓系惡性腫瘤且持續存在細胞減少症並已排除其他病例的特定病例。與我之前討論的檢測問題類似，這裡重要的是深度和廣度。我們對全基因組定序進行了 200 倍以上的覆蓋，該檢測旨在檢測所有具有臨床意義的基因組改變、突變、融合、拷貝數變化、表達，每個患者大約需要 16 億個讀取。

From a status standpoint, we have responded to MoIDX comments on our TA submission and will launch once coverage and pricing is determined. Next is Caris MI Clarity, which is tailored for breast cancer patients who are ER-positive HER2-negative generally Stage 1 or 2, and no negative or in certain cases, 1 to 3 positive nodes, particularly in post-menopausal patients. This solution has two alternative offerings, one combining my profound platform with digital AI and the other that is digital AI only.

從現狀來看，我們已經回應了 MoIDX 對我們技術援助申請的評論，一旦確定覆蓋範圍和定價，我們將立即推出。接下來是 Caris MI Clarity，它是為 ER 陽性 HER2 陰性的乳癌患者量身定制的，通常為 1 期或 2 期，且無陰性淋巴結或在某些情況下有 1 至 3 個陽性淋巴結，尤其適用於停經後患者。該解決方案提供兩種替代方案，一種是將我強大的平台與數位人工智慧相結合，另一種則僅包含數位人工智慧。

Both are intended to support both early and late recurrence risk score. The goal is straightforward, improve treatment decision-making and reduce unnecessary treatment while identifying patients who truly need to be receiving therapy. Operationally, we are in launch planning and pursuing reimbursement through the two pets. The NGS plus digital AI and digital only. We expect that the digital AI only path will be faster, and it is likely that we launch that version of the product first.

兩者均旨在支持早期和晚期復發風險評分。目標很明確，就是改善治療決策，減少不必要的治療，同時找出真正需要接受治療的病人。在營運方面，我們正在進行啟動計劃，並透過這兩隻寵物尋求報銷。NGS+數位人工智慧和純數位技術。我們預計純數位人工智慧方案會更快，而且我們很可能會先推出該版本的產品。

Importantly, both versions of my Clarity offer superior performance to currently available offerings. Third is Caris MRD tumor-naive where the intended initial use case is colorectal cancer. The clinical intent here is minimal residual disease assessment in patients with Stage 2 and 3 solid tumors postsecuritive intent treatment, helping to inform adjuvant therapy decision window.

重要的是，我的兩個版本的 Clarity 都比目前市面上的產品性能更優異。第三種是 Caris MRD 腫瘤初治患者，其預期的初始應用案例是大腸直腸癌。此處的臨床目的是對接受根治性治療的 2 期和 3 期實體瘤患者進行微小殘留病灶評估，以幫助確定輔助治療的決策窗口。

Importantly, this is designed to work from the whole blood sample without requiring an individualized tumor-informed assay build. As previously discussed, MolDX requested additional data, and we are working on creating and compiling that data, and we'll provide updates as we progress on that front.

重要的是，該方法無需針對腫瘤進行個人化檢測，即可利用全血樣本進行檢測。正如之前討論過的，MoldDX 要求提供更多數據，我們正在努力創建和整理這些數據，我們將在此方面取得進展並提供更新。

And then Caris MRD tumor informed, which is our whole genome approach intended for pan tumor applications in Stage 1, 2, and 3 disease. This is based on tumor-normal whole genome sequencing to identify patient-specific trackers with a proprietary approach designed to minimize false negatives. The strategy is to maximize tracker counts and to reach ultra-low PPM detection capability because in MRD, sensitivity at very low levels is required.

然後，Caris MRD 腫瘤訊息，這是我們的全基因組方法，旨在用於 1 期、2 期和 3 期疾病的泛腫瘤應用。這是基於腫瘤-正常組織全基因組定序，利用專有方法識別患者特異性追蹤器，旨在最大限度地減少假陰性結果。此策略是最大限度地增加追蹤器數量，並達到超低 PPM 檢測能力，因為在 MRD 中，需要非常低的靈敏度。

We've initiated development and launch planning, and we will continue to provide updates as we progress throughout the year. We have also launched five new AI signatures on our molecular tumor board reports that is available to physicians as part of our mine cancer seek in breast, pancreatic, brain, lung, and ovarian cancer.

我們已啟動開發和發布計劃，並將於今年內持續提供最新進展。我們還在分子腫瘤委員會報告中推出了五種新的 AI 特徵，醫生可以將其用於乳腺癌、胰腺癌、腦癌、肺癌和卵巢癌的診斷，這是我們癌症篩檢計畫的一部分。

These signatures offer insights into which patients will benefit from available approved therapies and show how our whole exome whole transcript on strategy provides the best therapeutic guidance and demonstrates how profiling is becoming more proprietary and not commoditized. Small panels of hundreds of genes are not sufficient to offer these types of insights. As Brian referenced in the investment strategy, our goal this year will be to continue to push on all pipeline activities as quickly as possible in order to make these comprehensive solutions available to improve the lives of patients.

這些特徵可以幫助我們了解哪些患者將從現有的已批准療法中受益，並展示我們的全外顯子組全轉錄組策略如何提供最佳的治療指導，以及分析如何變得越來越專有，而不是商品化。僅靠幾百個基因的小型基因檢測組不足以提供這類見解。正如布萊恩在投資策略中提到的那樣，我們今年的目標是繼續盡快推進所有研發管線活動，以便盡快提供這些綜合解決方案，從而改善患者的生活。

I will stop here, and I'll pass it over to Luke for the financial updates. Luke?

我就說到這裡，接下來交給盧克播報財務方面的最新情況。盧克？

Thanks, David. As Brian stated earlier, we had another outstanding quarter in terms of financial performance. So I'll run through some selected highlights prior to getting to the 2026 guidance.

謝謝你，大衛。正如布萊恩之前所說，我們在財務表現方面又取得了非常出色的季度成績。因此，在介紹 2026 年的指導方針之前，我將先回顧一些重點內容。

Turning to the financial overview slide. You can see we delivered another great quarter and finished our first year-end as a public company, very strong with total revenue increasing 97% for the full year, reflecting exceptional organic performance across the business. As part of this, you will notice that our final revenue numbers for Q4 and the year is about $12 million higher than our [prior] January numbers.

接下來是財務概覽投影片。可以看到，我們又取得了一個出色的季度業績，並以上市公司的身份圓滿完成了第一個年終，全年總收入增長了 97%，表現非常強勁，反映了公司整體業務的卓越內生增長。因此，您會注意到，我們第四季度和全年的最終收入數字比我們[之前的]1月份的數字高出約1200萬美元。

And this is the result of seeing continued positive collections from payers. So we adjusted our crude ASP rates in Q4 of '25 to account for these additional collections. The main driver of our 2025 growth as expected, was our molecular profiling business, which grew 120% compared to 2024, due to this ASP upset along with the volume growth.

這是由於付款方持續向好收款所致。因此，我們在 2025 年第四季調整了粗略的平均售價，以反映這些額外的收款。正如預期的那樣，我們 2025 年成長的主要驅動力是我們的分子分析業務，由於 ASP 波動和銷售成長，該業務與 2024 年相比成長了 120%。

Our therapy selection volumes were up 20% for the quarter and 22% year-over-year, slightly above our expectations and an improvement from the Q3 growth rate of 18% that Bobby mentioned. As discussed publicly, in January, while our pharma revenue was down year over year, we were happy with how it finished with our target discovery announcement with Genentech and fully expect to continue to build on that momentum into 2026.

本季我們的治療選擇量成長了 20%，年成長了 22%，略高於我們的預期，並且比 Bobby 提到的第三季 18% 的成長率有所提高。正如我們公開討論的那樣，1 月份，雖然我們的製藥收入同比下降，但我們對與基因泰克公司合作發現靶點的結果感到滿意，並完全期望在 2026 年繼續保持這一勢頭。

As we start to recognize revenue from that deal along with continuing to build on the contracting pipeline. Overall, our revenue growth and financial performance continues to show up on the bottom line, with positive adjusted EBITDA and positive free cash flow, not just for the quarter, but with positive adjusted EBITDA of $138 million and positive free cash flow of $67 million for the full year of 2025 and as Brian mentioned, we ended the year with over $800 million of cash on hand.

隨著我們開始確認該交易的收入，同時繼續拓展承包業務，我們將繼續推進。總體而言，我們的營收成長和財務表現繼續體現在淨利潤上，不僅本季實現了正的調整後 EBITDA 和正的自由現金流，而且 2025 年全年的調整後 EBITDA 為 1.38 億美元，自由現金流為 6,700 萬美元。正如 Brian 所提到的，我們年底的現金儲備超過 8 億美元。

2025 was a superb year in terms of molecular profiling services as you will see on slide 12. We took a measured approach as we entered the year in terms of stepping up our ASPs from the FDA approval of the MI Cancer Seek solution. And I'm delighted to say that after the maturity after 12 months, it has demonstrated real sustainable uptick with payers' appreciation appreciating the comprehensive approach of our solutions and the signatures that are also included as part of the offering, one of which we press released on Tuesday.

正如您將在第 12 張投影片中看到的那樣，2025 年是分子分析服務領域非常出色的一年。今年年初，我們採取了穩健的方式，逐步提高MI Cancer Seek解決方案的平均售價，此前該產品已獲得FDA批准。我很高興地宣布，經過 12 個月的成熟期，支付方對我們解決方案的全面方法以及產品中包含的簽名表示讚賞，這表明其實現了真正的可持續增長，其中一項簽名是我們週二發布的新聞稿。

As reflected on the slide, the favorable payer response led to additional revenue exceeding prior accruals with the majority of the additional revenue related to cases performed in 2025 and only $33.6 million being related to benefit from 2024 and prior year cases. This has resulted in us being able to reach an ASP for our 2025 cases of $3,876 per tissue and just above $2,500 for our blood asset. These improvements are due to various tailwinds we have seen occurred throughout 2025 and for which we expect to continue to benefit from in 2026. And we have listed some of these on the next slide along with the positive trend in molecular profiling gross margin.

如幻燈片所示，支付方的積極回應帶來了額外的收入，超過了先前的應計收入，其中大部分額外收入與 2025 年進行的病例有關，只有 3360 萬美元與 2024 年及以前年份的病例的收益有關。這使得我們能夠實現 2025 年組織樣本的平均售價為每份 3,876 美元，血液樣本的平均售價略高於 2,500 美元。這些改善得益於我們在 2025 年看到的各種有利因素，我們預計在 2026 年將繼續從中受益。我們在下一張投影片中列出了其中一些，以及分子譜分析毛利率的正面趨勢。

The key driver for tissue was obviously the impact from our FDA approval and the subsequent increase in pricing and the benefits we saw through contract, where we have now surpassed over 225 million covered lives from MI Cancer Seek. MI Cancer Seek represented greater than 70% of our tissue volume for the full year of 2025, almost over 75% of our tissue volume for Q4 and we're able to increase our tissue growth rate for the full year to over 16%, which was up from the 2024 growth rate.

組織的主要驅動因素顯然是 FDA 批准的影響以及隨後的價格上漲，以及我們透過合約獲得的收益，目前我們透過 MI Cancer Seek 已覆蓋超過 2.25 億人。MI Cancer Seek 占我們 2025 年全年組織體積的 70% 以上，第四季占我們組織體積的 75% 以上，我們能夠將全年組織成長率提高到 16% 以上，高於 2024 年的成長率。

For Caris Assure our PLA code was effective for the full year in 2025 and payers responded when we discuss both solutions together, and this played out in the reimbursement uptake over the past year. We've also seen a steady improvement each quarter as we continue to gain traction in volume, with Q4 reflecting a 13% sequential growth from Q3 of 2025.

對於 Caris Assure，我們的 PLA 代碼在 2025 年全年有效，當我們同時討論這兩種解決方案時，付款方也做出了回應，這在過去一年的報銷額度中得到了體現。隨著銷量持續成長，我們也看到每季都有穩定提升，2025 年第四季比第三季成長了 13%。

With regards to our Medicare ASP, as you know, our solutions went through clinical lab fee schedule pricing of CDLT and not ADLT. Accordingly, they are subject to the PAMA CDLT reporting process, which is on a 3-year cycle. As part of the recent Consolidated Corporations Act PAMA was amended so that the next reporting period is from January 1 to June 30, 2025. And based on the initial view of our data, we do not expect any downward adjustments to MI Cancer Seek the Caris Assure through 2029.

關於我們的 Medicare ASP，如您所知，我們的解決方案是透過 CDLT 的臨床實驗室收費標準定價，而不是 ADLT。因此，它們須遵守 PAMA CDLT 報告流程，該流程每 3 年為一個週期。作為最近《合併公司法》的一部分，PAMA 進行了修訂，以便下一個報告期為 2025 年 1 月 1 日至 6 月 30 日。根據我們對數據的初步觀察，我們預計到 2029 年 MI Cancer Seek the Caris Assure 不會有任何下調。

Staying on the same slide, the improved reimbursement had a very positive impact on the molecular profile in gross margin for the year as demonstrated by the progression seen on the graph. We finished at 66% GAAP gross margin for the full year. And even excluding the additional revenue from exceeding accruals for prior year cases, this was only slightly below that at 64%. This improved gross margin allows us to continue to invest and develop comprehensive offerings, validating the long-term approach we take with our solutions. All in all, it was a fantastic year from a financial performance standpoint, demonstrating the excellent work by everyone at Caris as we wrapped up our first year-end as a public company.

沿用先前的分析，報銷的改善對當年的毛利率分子特徵產生了非常正面的影響，如圖所示。我們全年的GAAP毛利率為66%。即使不計入因超額支付往年應計款項而獲得的額外收入，這一比例也僅略低於 64%。毛利率的提高使我們能夠繼續投資和開發全面的產品和服務，驗證了我們對解決方案的長期方法。總而言之，從財務表現的角度來看，這是非常棒的一年，這體現了 Caris 的每一位員工的出色工作，我們順利完成了作為一家上市公司的第一個年終總結。

Now turning to the outlook for 2026, which is reflected on slide 14. Consistent with our prior approach, we're initiating full year guidance based only on our current portfolio and will only add the pipeline solution to our guidance once they have started to generate revenue. This allows us to take a deliberate approach with gated investment strategies to ensure that these will flow through as milestones are met throughout the year. With the 2025 results, we delivered on our goal to demonstrate that our model can be self-sufficient to generate free cash flow.

現在來看看 2026 年的展望，這反映在第 14 張投影片中。與我們先前的做法一致，我們首先僅根據我們目前的投資組合發布全年業績指引，只有在管道解決方案開始產生收入後，才會將其添加到我們的業績指引中。這樣一來，我們就可以採取審慎的策略，制定分階段投資計劃，以確保這些投資能夠隨著全年里程碑的達成而逐步實現。透過 2025 年的成果，我們實現了目標，證明我們的模型可以自給自足地產生自由現金流。

And now going into 2026, our plan is to reinvest from this position of strength and continuing to progress on our differentiated pipeline along with our commercial infrastructure. Therefore, for the full year of 2026, we expect total revenue for existing solutions to be in the range of $1.0 billion to $1.02 billion, which represents growth of approximately 23% to 26% compared to 2025.

展望 2026 年，我們的計劃是利用這一優勢地位進行再投資，並繼續推進我們差異化的產品線以及商業基礎設施建設。因此，我們預計 2026 年全年現有解決方案的總收入將在 10 億美元至 10.2 億美元之間，與 2025 年相比成長約 23% 至 26%。

On the clinical side, therapy selection volume is expected to grow approximately 20% year over year in 2026, reflecting continued demand expansion and broader adoption across our ordering base. And as Bobby discussed previously, we've begun making those additional investments in the commercial organization. Within the total revenue range, we expect molecular profiling to grow approximately 21% to 22% in 2026. But excluding prior year additional revenue from exceeding previous accruals, this implies a molecular profiling growth rate of approximately 26% to 28%.

在臨床方面，預計 2026 年治療選擇量將同比增長約 20%，反映出需求持續增長以及在我們訂購群體中更廣泛的採用。正如鮑比之前討論的那樣，我們已經開始對商業組織進行額外的投資。在總收入範圍內，我們預計到 2026 年分子分析業務將成長約 21% 至 22%。但若不計入上一年因超過先前應計項目而獲得的額外收入，這意味著分子譜分析的成長率約為 26% 至 28%。

From an ASP standpoint, our focus remains on continuing to improve on commercial payer contracting as we progress into 2026. And for tissue, we're tracking towards approximately $4,000, a case which we now expect to reach in Q1, followed by continued progress throughout the year with this initial guidance reaching approximately $4,200 for the full year 2026. For blood, we expect ASP to be in the range of $2,400 to $2,500 for 2026 and will seek to further expand contracting, but any potential upside is not reflected in the guidance.

從 ASP 的角度來看，隨著我們邁入 2026 年，我們的重點仍然是繼續改進商業支付方合約。至於組織，我們正朝著 4,000 美元左右的目標邁進，我們預計第一季就能達到這個目標，隨後全年將持續取得進展，初步預期到 2026 年全年將達到 4,200 美元左右。對於血液製品，我們預計 2026 年的平均售價將在 2400 美元至 2500 美元之間，並將尋求進一步擴大合約範圍，但任何潛在的上漲空間均未反映在指導意見中。

With regards to pharma and research revenue, we expect $75 million to $85 million for the full year of 2026. This reflects contribution from our previously announced Genentech deal a recent companion diagnostic collaboration along with the development of contracting pipeline and our investment in additional dedicated team members for our pharma customers. As in prior years, we expect the cadence as more weighted to the second and fourth quarters, with Q1 and Q3 being lower than Q2 and Q4.

關於醫藥和研發收入，我們預計 2026 年全年收入將達到 7,500 萬美元至 8,500 萬美元。這反映了我們先前宣布的基因泰克交易、最近的伴隨診斷合作以及合約管線開發和我們為製藥客戶增加的專職團隊成員所做出的貢獻。與往年一樣，我們預計第二季和第四季的業績將更加突出，第一季和第三季的業績將低於第二季和第四季。

On the expense side, we expect GAAP operating expenses to be in the range of $590 million to $595 million, representing an increase of approximately 19% to 20%. This increase is primarily driven by the commercial expansion of pipeline trial activities, as demonstrated by the excellent results from G1 and also then including the Achieve 2 study of advancement of our Assure assay development models, including our planned New York State submission.

在支出方面，我們預計 GAAP 營運費用將在 5.9 億至 5.95 億美元之間，增幅約為 19% 至 20%。這一增長主要得益於管線試驗活動的商業擴張，G1 的出色結果證明了這一點，此外還包括 Achieve 2 研究，該研究推進了我們的 Assure 檢測開發模型，包括我們計劃向紐約州提交的申請。

Finally, with regard to free cash flow and adjusted EBITDA, we expect to remain positive for the year while funding these investments. One additional incremental item in 2026 will be CapEx as we prepare for the early detection launch. After spending approximately $16 million in 2025, we expect CapEx in the range of approximately $60 million for 2026.

最後，關於自由現金流和調整後 EBITDA，我們預計在為這些投資提供資金的同時，今年仍將保持正成長。2026 年新增的一項支出將是資本支出，因為我們將為早期檢測的推出做準備。2025 年支出約 1,600 萬美元後，我們預計 2026 年資本支出將達到約 6,000 萬美元。

This spend is tied to increased capacity and will be staged and milestone driven, so will not be applied all at once and spread throughout the year. As we have stated previously, we're not optimizing for peak margin in 2026 at the expense of long-term value, but we're committed to operating within our guardrails remaining positive free cash flow and adjusted EBITDA, while we execute on the milestone by continuing to drive our top line growth.

這項支出與產能提升相關，將分階段、按里程碑推進，因此不會一次全部投入，而是全年分攤。正如我們之前所說，我們不會為了在 2026 年實現利潤率高峰而犧牲長期價值，但我們致力於在保持正自由現金流和調整後 EBITDA 的前提下運營，同時透過繼續推動營收成長來實現這一里程碑目標。

I will wrap up there. And with that, we'll now turn the call back over to the operator.

我就說到這裡吧。那麼，我們現在將把通話轉回給接線生。

(Operator Instructions) Dan Brennan, TD Cowen.

（操作員說明）Dan Brennan，TD Cowen。

Great, thank you. Thanks for the question. Apologize if there's any background noise there. Maybe just first one, just on the volume outlook, the 20% volume growth. I don't think I've heard you did you guys break down how that's going to break down between tissue and blood. So you can give us that color? And then did you give us any color on pacing for revenues as well? So where should the first quarter land?

太好了，謝謝。謝謝你的提問。如果背景有噪音，請見諒。或許就第一點而言，就銷量前景而言，銷量成長20%。我好像還沒聽你們解釋過組織和血液之間是如何分解的。所以你能提供那種顏色嗎？那麼，您有沒有透露一下營收成長的預期目標？那麼第一季該落在哪裡呢？

Yeah. So Dan, so on a total volume basis, we guided to the 20%. The 20% is broken up very similar to Q4. So lower teens for tissue and then high-50s, lower-60s for blood from a growth standpoint. And then on the revenue outlook for Q1, right now, we're in that 70% to 74% growth range for total revenue.

是的。所以丹，從總量來看，我們預計達到 20%。這 20% 的組成與第四季非常相似。從生長角度來看，組織所需溫度在十度左右，血液所需溫度在五十多度到六十度左右。至於第一季的營收前景，目前我們預計總營收將成長 70% 至 74%。

Okay. And then maybe as a follow-up, so Bobby is now running the sales force. You've added some headcount. So can you elaborate a little bit on like how big the sales force was previously? What was the decision to bring Bobby in?

好的。然後，或許可以接著說，鮑比現在負責銷售團隊。你們增加了一些人手。那麼，您能否詳細說明一下之前銷售團隊的規模有多大？當時決定引進鮑比的原因是什麼？

How many people are you adding anything on the strategy? And then have you baked in any impact from these additional salespeople, will they drive revenues and volumes this year? Or is it going to hit in the fourth quarter? How do we think about the contribution from this added head count?

你們計劃在策略層面增加多少人？那麼，您是否已將這些新增銷售人員的影響納入考量？他們能否在今年推動營收和銷售成長？或者它會在第四節爆發？我們如何看待新增人員帶來的貢獻？

Yeah, yeah. So I can definitely take that, and then I'll let Bobby chime in on. So effectively, Bobby joined us, obviously, to lead our reimbursement efforts, knowing that Bobby also has additional expertise that would transition into the commercial operating role in the future. So from that standpoint, Bobby, obviously, has been here kind of 1 year, 1.5 years right now and done excellent work, as you can see in our results with the reimbursement.

是啊是啊。所以我絕對可以接受，然後我會讓鮑比插話。因此，很顯然，鮑比加入我們是為了領導我們的報銷工作，因為我們知道鮑比還有其他專業知識，將來可以過渡到商業營運角色。所以從這個角度來看，很明顯，Bobby 在這裡已經工作了大約 1 年到 1.5 年，並​​且做得非常出色，正如你從我們的報銷結果中看到的那樣。

So as we go forward and what we're planning for 2026, we announced at JPMorgan that we were about 250 salespeople, and we wanted to increase it about 20% to 25%. So get that back up to about 300 people. Again, Bobby has done great work with kind of going through the territories and see where we can get the most benefit from that.

所以，展望未來，在 2026 年的計畫中，我們在摩根大通宣布，我們大約有 250 名銷售人員，我們希望將其增加 20% 到 25%。所以要把人數恢復到300人左右。再次強調，Bobby 在考察各個地區並找出我們可以從中獲得最大利益方面做得非常出色。

To answer your last question before I pass it to Bobby, we incorporated the expense, but we're taking a measured approach with our volume. We obviously think this is going to pay off for us in the second half of the year, but that's not incorporated in the 20% number. The 20% we were able to achieve in Q4, which was what we were expecting to go into 2026. So I definitely think once we have further experience with the uptick in salespeople and obviously, all the initiatives Bobby is implementing that you could see benefits, but we're not guiding to that right now.

在把問題轉給鮑比之前，先回答你的最後一個問題：我們已經把這筆費用考慮進去了，但是我們對業務量採取的是謹慎的態度。我們顯然認為這將在今年下半年為我們帶來回報，但這並沒有包含在 20% 的數字中。我們在第四季實現了 20% 的目標，而我們原本預計這個目標要到 2026 年才能實現。所以我認為，一旦我們累積了更多銷售人員增加的經驗，並且鮑比正在實施的所有舉措也都奏效，我們就能看到成效，但我們目前還沒有把方向指向這一點。

Got it. Thank you.

知道了。謝謝。

Subbu Nambi, Guggenheim.

蘇布南比，古根漢美術館。

Spetz, thank you for sharing the MSA interim data you provided specificity data, which delineates between asymptomatic screening and undiagnosed population -- can you further define these populations? How do they differ? And why did you do this? What is the significance from the perspective of clinical regulatory reimbursement and commercial?

Spetz，感謝您分享您提供的 MSA 中期數據和特異性數據，這些數據區分了無症狀篩檢族群和未確診族群——您能否進一步定義這些族群？它們有何不同？為什麼要這樣做？從臨床監管報銷和商業角度來看，其意義是什麼？

Yeah. So in the higher-risk population, what we saw was that there was a 7% undiagnosed cancer rate. And so -- now if 7% of your control samples are actually positive for cancer, then it's going to lead to a lower estimate of specificity than what you would see in a general population where the incidence rate is much, much lower.

是的。因此，在高風險族群中，我們發現未確診的癌症發生率為 7%。因此——如果你的對照樣本中有 7% 實際上患有癌症，那麼這將導致特異性估計值低於你在一般人群中看到的特異性估計值，因為一般人群的發生率要低得多。

And so the kind of clean cohorts where we have the longitudinal outcome data showing that they are actually healthy patients is going to be reflective of the specificity in that general healthy screening population, whereas the or the symptomatic screening population, that high-risk group is what we would expect in high-risk clinics. And so the clinical context of the patient matters a lot in how we think about the results, and we want to make sure that we're clear and careful about characterizing test performance across the various populations that we'll be marketing (inaudible) --?

因此，這類乾淨的隊列，我們有縱向結果數據表明他們實際上是健康的患者，這將反映出一般健康篩檢人群的特異性，而有症狀的篩檢人群，即高風險人群，則是我們在高風險診所中預期的人群。因此，患者的臨床背景對我們如何解讀結果至關重要，我們希望確保在描述我們即將推廣的不同族群的檢測表現時，能夠做到清晰而謹慎。（聽不清楚）——？

Very helpful. And Luke, you did mention how pharma -- how AI is going to be a tailwind and how the database is going. Do you have an early outlook to share on the pharma R&D spending environment at all as far as increasingly looking to spend on AI and could Caris be a beneficially?

很有幫助。盧克，你確實提到了製藥業——人工智慧將如何成為推動其發展的順風，以及資料庫的發展。您能否就製藥研發支出環境的早期展望分享一下，尤其是在人工智慧領域投入日益增加的情況下，Caris 能否帶來益處？

I definitely think we could be a beneficiary, especially from our molecular data set that now has over 1 million profiles. But from our guidance standpoint, Subbu, like the $75 million to $85 million, it's based on looking at what we've been able to do historically from a base run rate, knowing that we signed the additional Genentech deal that we publicly announced.

我確信我們肯定會從中受益，特別是我們目前擁有超過 100 萬個分子數據的數據集。但從我們的指導角度來看，Subbu，就像 7500 萬美元到 8500 萬美元一樣，這是基於我們過去能夠達到的基本運行率，以及我們公開宣布的與 Genentech 的額外交易。

We have a couple of CDx collaborations, one that was completed that we're not announcing publicly at the request of our pharma partner, that allows us and gives us great confidence as we go into the year in order to achieve that. But you're right, there's definitely a lot of trends, and we've had continued outreach, particularly around our data and the use of that in AI.

我們有幾項 CDx 合作項目，其中一項已經完成，但應我們製藥合作夥伴的要求，我們不會公開宣布。這讓我們對今年實現目標充滿信心。但你說得對，確實有很多趨勢，我們也一直持續進行宣傳推廣，特別是圍繞我們的數據以及這些數據在人工智慧中的應用。

Michael Ryskin, Bank of America.

邁克爾·里斯金，美國銀行。

Congrats on the quarter. Dan asked on volumes, I guess, on like the ASP 1 for tissue, I think ended correctly, you talked about 4000 in the first quarter and then reaching approximately 4,200 for the full year. I recognize obviously there's a lot of ASP true-up in 3Q and 4Q, but that still seems like relatively conservative relative to what we talked about in the past and the ability to reach sort of closer to that high 4,000 range. Just wondering if you could talk about how much conservative you have built into that what your line of sight is on the commercial side of things and just sort of talk about the -- what true-ups could contribute on top of that.

恭喜你本季取得佳績。Dan 問到了銷量，我猜是關於紙巾的平均售價 1，我認為最後說得對，你提到第一季度是 4000，然後全年達到大約 4200。我當然知道第三季和第四季的平均售價會有很多修正，但這與我們過去討論的內容相比仍然顯得相對保守，而且我們有能力達到接近 4000 美元的高點。我只是想知道您能否談談您在商業方面融入了多少保守因素，以及您在這方面的視角，並談談——在此基礎上，哪些調整可以發揮作用。

Yes. So the answer to true-up questions. Like we purposely launch my cancer seek at the start of 2025, knowing that we'd get the full 12 months of the activity. So we could get all the kind of true-ups incorporated as much as possible in 2025. A Because, again, I always take a measured approach when it comes to ASP, I'd like to see the history play out.

是的。所以，這就是對核對問題的回答。就像我們特意在 2025 年初啟動我的癌症篩檢活動一樣，因為我們知道我們將獲得完整的 12 個月的活動時間。這樣我們就可以盡可能地在 2025 年將所有類型的調整納入考慮。因為，再說一遍，我對ASP總是採取謹慎的態度，我想看看歷史會如何發展。

And now that we have that -- it's a good starting point as we go in and knowing that we'll get to the 4,000 based on the contracts we signed that kick in at the start of the year. I definitely think there's headroom there. But I do want to be measured again going into this year. We've done excellence on ASP. Obviously, it's the best in the industry, and it's due to the decision David Halbertmade to go to whole eggs and the whole transcriptome like five years ago.

現在我們有了這個——這是一個很好的起點，因為我們知道，根據我們年初簽署的合同，我們將達到 4,000 的目標。我覺得這方面一定還有進步空間。但我希望在今年再次接受評估。我們在ASP方面做得非常好。顯然，它是業內最好的，這要歸功於大衛哈伯特大約五年前決定使用全蛋和整個轉錄組。

that has paid off for us. So going into it, the 4,200 is kind of where I want to guide to right now. And then we'll progress will progress throughout the year. We'll get additional contracts, as Bobby said, and then we'll just see, Mike, where shoots up. But from a guidance standpoint, I feel really good right now with the 4,200 for the full year. Eight years ago. Yes.

這對我們來說是值得的。所以，目前我的目標價位是 4,200。然後，我們將在這一年中繼續取得進展。正如鮑比所說，我們會獲得更多合同，然後我們再看看，邁克，情況會如何發展。但從業績指引的角度來看，我對全年 4,200 的目標感到非常滿意。八年前。是的。

Good point. Good point. And then for my follow-up, for the guidance for this year, you kind of left it relatively open ended in terms of adjusted EBITDA positive. There's a big range to what positive means. And I think just to combine this with a commercial reinvestment point.

說得對。說得對。至於我的後續問題，關於今年的業績指引，您在調整後 EBITDA 為正方面並沒有給出明確的答案。「積極」的涵義範圍很廣。我認為應該將此與商業再投資結合。

Could you maybe talk about the puts and takes of that? How much of a lever you think that could be? And sort of how you think about that balance, right, of investing, getting maybe a little bit more on the margin side of things versus the other way around?

您能否談談其中的利弊？你認為這會有多大的影響力？那麼，你如何看待這種平衡呢？例如投資方面，是不是應該稍微多關註一下利潤空間，而不是反過來？

Yeah, it's going to be pure like utilizing the leverage, Mike. So for us, obviously, we're able to generate like over $136 million of adjusted EBITDA for the full year of we're going to utilize that going in. So you obviously see the increase of $100 million in OpEx. What we're planning on doing, especially in the first half of the year is utilizing that. And I've stated on multiple calls, obviously, since we became public like the deal go for me going into 2026 would be to kind of run neutral in the first half of the year just by getting these investments done.

是的，這就像利用槓桿一樣純粹，麥克。所以對我們來說，很顯然，如果我們能利用這筆資金，我們全年就能產生超過 1.36 億美元的調整後 EBITDA。所以很明顯，營運支出增加了 1 億美元。我們計劃，尤其是在今年上半年，充分利用這一點。而且我在多次電話會議上都說過，顯然，自從我們上市以來，我對於2026年的目標就是在上半年保持中立，完成這些投資。

Now we'll continue to generate. We're generating, obviously, the $60 million-plus of free cash flow because of the position we're in, we're going to utilize this. And again, that's why we're just guiding to being positive right now. I'm not going to throw out that it's going to be $150 million or $200 million.

現在我們將繼續生成。很顯然，由於我們目前的處境，我們產生了超過 6000 萬美元的自由現金流，我們將充分利用這些資金。所以，我們現在才要引導大家保持積極的心態。我不會妄下斷言最終金額會是 1.5 億美元還是 2 億美元。

But if we execute, obviously, we continue to drive margin from a profitability standpoint past 2026 and into 2027. And obviously, we're very excited with the early detection launch, and that's kind of the primary focus for the first half of this year.

但如果我們執行到位，顯然，從獲利能力的角度來看，我們將在 2026 年後以及 2027 年繼續提高利潤率。顯然，我們對早期檢測技術的推出感到非常興奮，這也是今年上半年的主要工作重點。

Okay, thanks for taking my question.

好的，謝謝您回答我的問題。

Vijay Kumar, Evercore ISI.

Vijay Kumar，Evercore ISI。

Hey, guys. Thanks for taking my question Maybe, Luke, my first one is on ASP assumptions here for fiscal '26. Did I hear you correct when you said blood is $2,400 to $2,500? I thought the fiscal extra blood ASP was north of $2,500. So maybe just walk me through on why blood steps down and that $4,200 on the tissue side. does it contemplate the full normalization of PLA uplift on the CMS side? Or is there some more room left when you think about '27.

嘿，夥計們。謝謝你回答我的問題，盧克，我的第一個問題是關於 2026 財年的平均售價假設。我沒聽錯吧，你說輸血的價格是 2400 到 2500 美元？我以為額外的血液銷售平均售價超過 2500 美元。所以，您能不能詳細解釋為什麼血液含量會下降，以及組織方面的費用為何是 4200 美元？這是否考慮到了 CMS 側 PLA 提升的完全正常化？或者，當你想到 27 年的時候，是否還有一些空間？

Yes. So answer to the blood first. I'd like to guide from a blood standpoint in the $100 range, like you're right, like the $2,500 is kind of at the top of that range is where we ended up. I definitely think there's some upside to that, as I mentioned in the pre-prepared remarks. So right now, what I would guide to is in that $2,400 to 2$,500 just based on the mix of cases is where we came up with that guideline because obviously, Medicare has paid better, commercials paid a little less and there's sometimes fluctuation amongst that in the quarter, especially as we ramp up our blood volume.

是的。所以先回答血液方面的問題。我想從血液檢查的角度來指導一下，價格在 100 美元左右，就像你說的，2500 美元算是這個價位的上限，我們最終也確定在這個價位。正如我在事先準備好的演講稿中提到的，我認為這肯定有一些好處。所以目前，我的指導意見是，根據病例組合，價格在 2400 美元到 2500 美元之間，這是我們根據病例組合得出的指導方針，因為很明顯，Medicare 的支付情況更好，商業保險的支付情況稍差一些，而且季度內兩者之間有時會有波動，尤其是在我們增加血液供應量的時候。

Obviously, it's been growing quite nicely from a sequential standpoint. So that's the reason for the $2,400 to $2,500. But I'm not guiding to us like a massive step down or anything. I just want to be cautious with the guide from the blood ASP.

顯然，從發展速度來看，它的成長相當不錯。所以這就是價格在 2400 美元到 2500 美元之間的原因。但我並不是暗示我們這是一次巨大的倒退之類的。我只是想謹慎對待血液 ASP 的指南。

And then on tissue, we put out the metrics that obviously, over 75% of our tissue volume is going to be under the PLA code, and we're making great progress there.

然後，關於組織，我們公佈的指標顯示，顯然，超過 75% 的組織體積將採用 PLA 代碼，我們在這方面取得了巨大進展。

But you do have the remaining 25%, that's not. So we've hit our goal that we came into the year in order to get above that kind of $3,600 for Q4 and obviously announcing that we're going to get to $4,000 for Q1. And I feel good with the progress that our excellent market access team is making, along with our billing team to continue to push on that and get that to a higher rate. But now from a guidance standpoint, like the $4,200 feels really, really good right now, and that's what I want to stick with from the guidance standpoint.

但你還有剩下的 25%，不是嗎？因此，我們實現了年初設定的目標，第四季度營收超過 3,600 美元，我們宣布第一季營收將達到 4,000 美元。我對我們優秀的市場准入團隊的進展感到滿意，同時我們的計費團隊也在繼續努力，爭取將費率提高到更高水準。但就業績效指引而言，目前 4,200 美元的目標價感覺非常好，這也是我希望堅持的目標價。

Understand. Just to be clear, too, that 4200 volumes under PLA in 2026?

理解。另外，需要明確一點，2026 年 PLA 下的產量是 4200 公升嗎？

Correct.

正確的。

Understood. Then maybe my follow-up on this step-up in OpEx spend for '26. I'm curious, when I look at the market, the market seems to be rewarding companies in the space for volume growth rate versus you guys being focused on profitable growth and that's a distinction that you made. Does this OpEx step-up signal that, hey, if the market is not rewarding cars on profitable growth, let's put volumes.

明白了。接下來，我可能會跟進 2026 年營運支出增加的情況。我很好奇，當我觀察市場時，市場似乎更青睞銷量成長率高的公司，而你們則更注重獲利成長，這是你們提出的差異。此次營運支出增加是否表明，如果市場沒有獎勵汽車的獲利成長，那麼我們就應該追求銷售。

So just walk us through the rationale of this OpEx step-up where is the spend going? Is this for existing test for new test? And when you think about productivity per rep, how long did it pay for these reps these new reps to get productive?

那麼請您詳細介紹一下此次營運支出增加的理由，這些錢都花在哪裡了？這是針對現有測試的新測試嗎？當你考慮每個銷售代表的生產力時，這些新銷售代表需要多長時間才能達到生產力水準？

Yeah. So I'll go first and then I can let team obviously chime in as well. So yes, it's definitely including the OpEx standup step up like 30% growth in sales and marketing. So that's kind of the number one key area. The other -- the second key area, too, is in R&D and having that other 30% step up in R&D, again, as Pat walked through with the C1, like we're extremely excited about that, and we want to keep pressing ahead with the Achieve 2 data. So that's going to be a priority from the R&D spend standpoint.

是的。那我先說，然後我的團隊成員當然也可以參與討論。所以，是的，這肯定包括營運支出方面的顯著提升，例如銷售和行銷方面成長 30%。所以這可以說是最重要的領域。另一個關鍵領域——第二個關鍵領域——是研發，以及讓另外 30% 的人員加大研發投入，正如 Pat 在 C1 階段所展示的那樣，我們對此感到非常興奮，我們希望繼續推進 Achieve 2 的數據。所以從研發投入的角度來看，這將是優先事項。

And then with the sales and marketing, normally, it takes about six months for that to play out. But again, what we did with our guide because -- we did a great job last year of coming out and being measured on what we're guiding to. We didn't want to assume any big uptick in the second half of the year. again, all companies go through this year.

然後，銷售和市場推廣通常需要大約六個月的時間才能見效。但話說回來，我們之所以和我們的嚮導合作，是因為——去年我們做得很好，我們出來後接受了評估，評估了我們所指導的內容。我們不想假設下半年會大幅成長。畢竟，所有公司都會經歷這一年。

Q1 obviously ramps up to Q2, Q3, and Q4, and that's what's in these numbers. But we're not assuming any big uptick from a volume standpoint until probably obviously get these initiatives implemented. And then we'll come back to -- the Street how we progressed. And then I don't know, Brian, if you want to take the first one?

第一季顯然會逐步過渡到第二季、第三季和第四季度，這些數字就反映了這一點。但從銷售角度來看，我們預期在這些措施得到落實之前，銷售量不會大幅成長。然後我們會回到——這條街上，看看我們是如何取得進展的。那麼，布萊恩，我不知道你是否願意接受第一個？

Listen, I would answer it a little more generally, which is, Vijay, I think we see a tremendous amount of opportunity in the market. it's not penetrated. Rather, we see with sites all of the time, more physicians that need the best technology. So we're extremely optimistic about the opportunities in front of us, not just with the new modalities like MSD, but just with our existing core business and therapy selection.

聽著，我的回答會更籠統一些，那就是，Vijay，我認為我們看到了市場上的巨大機遇，它還沒有被充分開發。相反，我們經常看到，越來越多的醫生需要最好的技術。因此，我們對擺在我們面前的機會非常樂觀，不僅是像 MSD 這樣的新模式，而且是我們現有的核心業務和治療選擇。

So with our technology solutions, and we think the best technology solutions on the market, and we're super excited with Bobby's leadership to for more resources human capital programs, et cetera, behind this to support our cancer center clients as well as individual oncologists through educational programs, the MSL teams, et cetera, et cetera, as we go through this continued evolution in molecular information.

因此，憑藉我們的技術解決方案，我們認為這是市場上最好的技術解決方案，我們非常高興在 Bobby 的領導下，能夠投入更多資源，包括人力資本計劃等等，來支持我們的癌症中心客戶以及腫瘤科醫生，透過教育計劃、醫學聯絡官團隊等等，在我們經歷分子信息持續發展的過程中。

So we're just super excited. And with Bobby's leadership now, we can invest even more aggressively. So I think that's where this is coming from.

所以我們都非常興奮。有了鮑比的領導，我們現在可以加強投資。所以我認為這就是問題的根源。

Udnerstood. Thank you, guys.

下。謝謝大家。

Doug Schenkel, Wolfe Research.

道格‧申克爾，沃爾夫研究中心。

Hi. This is Colleen on for Doug. One on CapEx. We think we heard Luke mentioned $60 million in CapEx dedicated to the MSE launch this year. Can you just share any more color on how you plan to allocate that spend?

你好。這裡是Colleen，替Doug為您報道。一項關於資本支出。我們好像聽到盧克提到今年將有 6000 萬美元的資本支出用於 MSE 的啟動。您能否詳細說明一下您計劃如何分配這筆支出？

Yes, pretty evenly, tether, Colleen, maybe a little bit more weighted. So like 35%, 25% first half, second half of the year. It will all depend on how quickly we can get their early detection ramped up. we're working very, very quickly on that right now.

是的，相當均勻，繫繩，科琳，可能稍微重一些。所以就像上半年佔 35%，下半年佔 25%。這一切都取決於我們能否盡快提升早期檢測能力。我們目前正在非常迅速地推進這項工作。

One of the key items from the CapEx standpoint is, obviously, our new Assure assay is going to be switched over to the NovaSeq. And NovaSeq is also what we're using for early detection. So there's going to be additional NovaSeq machines that we'll purchase as well throughout the first half of this year and that we've already ordered -- so that's kind of how it's broken up. It's a lot related to testing equipment and then additional spend related to capacity and buildings.

從資本支出角度來看，關鍵項目之一顯然是，我們的新 Assure 檢測將切換到 NovaSeq。NovaSeq也是我們用於早期檢測的技術。所以今年上半年我們還會購買更多的 NovaSeq 機器，而且我們已經訂購了這些機器——大致情況就是這樣。這主要涉及測試設備，以及與產能和建築相關的額外支出。

All right. And then more broadly on capital deployment. Now that the business has demonstrated profitability and you have about $800 million on the balance sheet, how are you prioritizing incremental sales and marketing and R&D investment versus opportunities M&A? And are there any portfolio gaps you would look to fill strategically versus prioritizing smaller tuck-ins?

好的。然後更廣泛地談到資本部署。既然公司已經證明了盈利能力，並且資產負債表上有大約 8 億美元，您是如何權衡銷售、行銷和研發投資的優先級，以及併購機會的優先級？您是否會考慮透過策略性投資來填補投資組合中的某些空白，而不是優先進行一些小規模的補充投資？

No. I think, look, we're always being very strategic in what we do. We have a great assay in-house. And obviously, we always focus on the technology first at Caris. So that's going to be a primary thing.

不。我認為，我們做事一直都很有策略。我們公司內部有很棒的檢測方法。顯然，在Cari​​，我們始終把技術放在首位。所以這將是首要任務。

But we remain strategic and obviously, the flexibility that we have based on our financial performance and the cash on hand, gives us an opportunity to just continue to assess. But we're going to push on all fronts, and then we'll see what actually shakes out.

但我們仍然保持策略性，而且顯然，根據我們的財務表現和手頭現金，我們所擁有的靈活性使我們有機會繼續進行評估。但我們將全力以赴，然後看看最終結果如何。

Casey Woodring, JPMorgan.

Casey Woodring，摩根大通。

Great. Thanks for taking my quesitons. This is Sebastian on for Casey. Can you talk a little more about expectations for volume pacing? It sounds like you're not making any impact from new reps. I think you talked about mid-teens growth-ish for tissue and then something in the mid-30s for blood.

偉大的。謝謝您回答我的問題。這是塞巴斯蒂安替凱西上場。能否再詳細談談音量控制的預期？聽起來你新練的次數並沒有帶來任何效果。我想你之前說過，組織大約在青少年中期開始發育，而血液大約在三十多歲中期開始發育。

Would you expect to grow above that in the first half and then below in the back half pending you ramp from new reps? And then just what's your expectation there for 1Q? And I have a quick follow-up.

你預期前半程的成績會高於這個水平，後半程會低於這個水平，這取決於你如何透過增加訓練次數來提升成績嗎？那麼，您對第一季有何預期？我還有一個後續問題。

Yes, Sebastian. I probably you flipped that. So obviously, like we're continuing to ramp that up. What I said was when I think Dan asked the question was the tissue being like low teens, consistent with where Q4 was. And then blood being in that high-50s. So like 59% is where we came in for Q4.

是的，塞巴斯蒂安。我猜你把那個反過來了。很明顯，我們正在繼續加大力度。我當時說的是，我認為丹問這個問題的時候，組織樣本的數值就像十幾，與第四季的情況一致。然後血液數值接近50。所以，我們第四季的佔比是 59%。

So that's what's assumed in the guide. Now for Q1, obviously, you can see based on our historical performance, like you do have a little bit of push between Q1 and Q3 and then Q2 and Q4 pop. And you see that historically play out in our financials, just based on schedules, holidays, et cetera. But I would think that as we ramp into the second half of the year, I feel very good about that 20% from an overall year standpoint.

所以，這是指南中假設的前提。現在來看第一季度，很明顯，根據我們過去的表現，你可以看到第一季度到第三季度之間確實有一些推動作用，然後第二季度到第四季度之間出現爆發式增長。從歷史數據來看，這在我們的財務狀況中得到了體現，這主要取決於日程安排、假期等等。但我認為，隨著我們進入下半年，從全年整體來看，我對這 20% 的成長感到非常滿意。

Got it. And then just one on the [MSA] data you reported. So the interim data looks strong. I noticed apart from the top three or so indications, it looks like the sample size is pretty small. I guess, first off, do you think smaller sample size for some of these indications would impact how physicians and patients feel about -- are comfortable using the test?

知道了。然後，就你報告的[MSA]數據而言，只有一點。所以中期數據看起來不錯。除了前三項左右的指標外，我注意到樣本量似乎相當小。首先，我想問的是，您認為對於某些適應症而言，較小的樣本量是否會影響醫生和患者對使用該測試的感受——以及他們使用該測試的舒適度？

And then it looks like the breast sensitivity is well above peers and the sample size there is sufficiently large. So like is there any scenario where you would consider offering a stand-alone breast test in addition to [MSA]?

而且，乳房敏感度似乎遠高於同齡人，並且樣本量也足夠大。那麼，是否存在這樣的情況：除了其他檢查之外，您還會考慮單獨提供乳房檢查？[MSA]？

So yes, as you noted, the performance in breast is really, really good. And compared to like methylation-based tests that have single-digit sensitivities in early stage that shows a lot. But for us to go breast only kind of creates an ethical quandary because we wouldn't want to not report out when we find other cancers there.

所以，正如你所指出的，乳房發育方面的表現確實非常好。與早期靈敏度只有個位數的甲基化檢測相比，這說明了許多問題。但如果我們只關注乳腺，就會造成一種倫理困境，因為我們不想在發現其他癌症時不予報告。

So the performance is really strong. And one of the reasons why the numbers are lower in some of those other categories is because not a lot of patients are found at early stage because there are no existing screening modalities that are very effective. And so -- we'll see that continue to play out over time where with our technology and our test, we will be the ones finding those early-stage cancers. And so those numbers will go up simply because we're -- we're now able to find them at the early stage.

所以表現非常出色。其他一些類別中的數字較低的原因之一是，由於目前還沒有非常有效的篩檢方法，因此早期發現的患者不多。因此，隨著時間的推移，我們將看到這種情況繼續發生，憑藉我們的技術和檢測方法，我們將能夠發現那些早期癌症。因此，這些數字將會上升，原因很簡單，我們現在能夠在早期階段發現它們。

Patrick Donnelly, Citi.

派崔克唐納利，花旗銀行。

Hey, guys. Thanks for taking questions. Probably one for Luke. I think a little bit of a follow-up there. I just wanted to talk through what's baked into the guide for the new hires. How are you thinking about the pacing of hiring, how quickly they become productive and then is there anything for [MSA] in the numbers? Just wanted to talk through that.

嘿，夥計們。謝謝回答問題。可能是給盧克的。我覺得還需要一些後續說明。我只是想和大家聊聊新進員工指南裡都包含了哪些內容。您如何看待招募節奏，他們多久才能投入工作，以及這些數據對[MSA]有何意義？只是想跟你聊聊這件事。

Yeah. So on the new hires, Patrick, effectively, we're trying to get everything done in the first half of the year, getting them hard as quickly as possible. So that's baked into kind of those views.

是的。所以，派崔克，關於新員工，實際上，我們正​​在努力在今年上半年完成所有工作，盡快讓他們步入正軌。所以這已經根深蒂固地融入這些觀點之中了。

Yeah, yeah, yeah. And on -- yeah.

是啊，是啊，是啊。嗯。

Yes. So we have already posted all of the positions that we ramp up in the first phase. We've already started hiring four positions that have been posted already in 2026. We made this decision and announcement internally on January 6. And when we've been ramping up those new hires.

是的。所以我們已經發布了第一階段需要擴充的所有職缺。我們已經開始招募2026年發布的四個職位。我們在1月6日內部做出了這項決定並發布了公告。當我們一直在增加新員工數量的時候。

We are also going to be ramping up hiring for MSA as a field-based sales force, along with the announcement that we had with the partnership with -- every well that we announced back in January. And so we're ramping up a multichannel approach in order to address both of those markets. And then we've also updated our training. Both how we internally get people up to speed in order to help physicians and patients with comprehensive genomic profiling with their current offering and set us up for our new launches.

我們還將加大對 MSA 現場銷售團隊的招募力度，同時推進我們在 1 月宣布的與每一口油井的合作。因此，我們正在加強採用多通路方式，以滿足這兩個市場的需求。此外，我們也更新了培訓內容。既要讓內部人員快速掌握相關知識，以便利用現有產品為醫生和患者提供全面的基因組分析，也要為我們的新產品發布做好準備。

That's helpful. I appreciate that. And then obviously, a lot of talk on MSD. Just quickly, I wanted to check on the MRD part of the portfolio. Any catalyst we can be looking out for time lines would be helpful.

那很有幫助。我很感激。當然，還有很多關於默沙東（MSD）的討論。我只是想快速查看一下投資組合中的 MRD 部分。任何有助於我們把握時機的催化劑都將有所幫助。

We have to collect more data and part of that process is the maturing of clinical outcome data. So we don't -- we're not guiding to any time line on that front. Just have to keep accruing samples and outcome data.

我們需要收集更多數據，而這個過程的一部分就是臨床結果數據的完善。所以，我們不會——我們不會在這方面給出任何時間表。只需要不斷累積樣本和結果數據。

Mark Massaro, BTIG.

馬克·馬薩羅，BTIG。

Hey, guys. Thanks and congrats on strong 2025. I did want to follow up on the MSD commentary. It's interesting you guys indicated that you do plan to to have a sales force for the MSA opportunity.

嘿，夥計們。謝謝，並祝賀您在2025年取得巨大成功。我想就默沙東的評論做個後續報導。你們表示計劃為MSA專案組建銷售團隊，這很有意思。

Can you just give us a sense for -- by the end of '26 or the end of '27, can you give us a sense for sizing I think Garden is out there now with about 300 with plans to go to 600. I was just curious if you could give us maybe some type of a sense of what type of size you would want direct relative to some of your partners like Everly well?

您能否大致估算一下－到 2026 年底或 2027 年底，您能否大致估算一下規模？我認為 Garden 目前大約有 300 個，並計劃擴展到 600 個。我只是好奇，您能否大致描述一下您想要的尺寸，並參考一下您和伴侶（例如Everly）的尺寸？

Yeah, I think a good question. I think as Luke mentioned, when we take a measured approach, we'll take a measured approach when we build out our (inaudible) salesforce will start small, we know where to target. We've already had some collaboration discussions, and we'll take a measured approach as we get through the year and look at capacity and go through the launch.

是的，我覺得這是個好問題。我認為正如盧克所提到的那樣，當我們採取穩健的方法時，當我們組建（聽不清楚）銷售團隊時，我們會從小規模開始，我們知道目標群體在哪裡。我們已經進行了一些合作討論，我們將採取穩健的方式，在今年餘下的時間裡，考察產能並推進產品發布。

Makes sense. And then 1 for David Spetzler. Can you give us a sense for timing on Avhiece 2 and maybe just the -- I don't know if it's 10,000 or 15,000 subjects, but just give us a sense of the size. And are there any particular bogeys that you're looking at either for Stage 1 or Stage 2 sensitivity.

有道理。然後是戴維·斯佩茨勒。你能大概說說 Avhiece 2 的時間安排嗎？還有——我不知道是 10,000 個還是 15,000 個對象，但請大概說說規模。對於第一階段或第二階段的敏感度測試，您是否特別注意某些障礙物？

So Achieve 2 will be 25,000 total. A big part of that are precancerous components. So we'd really like to be able to characterize the performance of our test in patients that have polyps, for example. And that will be a big part of that cohort -- we still need to enroll probably 8,000 or so patients in order to hit that final number. But the flip side of that means that we have about 18,000 samples in-house now that we can start running.

所以 Achieve 2 的總目標將是 25,000。其中很大一部分是癌前病變成分。因此，我們非常希望能夠描述我們的測試在患有息肉的患者中的表現。這將是該群體的重要組成部分——我們可能還需要招募大約 8000 名患者才能達到最終目標人數。但另一方面，這意味著我們現在內部有大約 18,000 個樣本可以開始運作了。

So just like we did with Achieve 1, we'll issue interim results as we get them and characterize that performance in these populations of patients where there's an opportunity to act before insurance in cancer. That's going to help bend that mortality curve massively.

就像我們對 Achieve 1 所做的那樣，我們將在獲得結果後發布中期結果，並描述這些患者群體中的表現，因為在癌症保險生效之前，我們有機會採取行動。這將有助於大幅降低死亡率曲線。

And maybe just to clarify, are you able to launch Cares Detect even absent the full readout of Achieve 1? Or how are you thinking about the timing of that?

另外，為了更清楚說明，即使沒有 Achieve 1 的完整讀數，您是否也能啟動 Cares Detect？或者，您覺得時機如何？

Yeah. We're going to launch when we have the final readout on Achieve 1. So Achieve 1 is our final accuracy study that will enable launch.

是的。我們將在獲得 Achieve 1 的最終讀數後發布。因此，Achieve 1 是我們最終的精度研究，它將使我們能夠進行產品發布。

Kyle Mikson, Cannacord Genuity.

Kyle Mikson，Cannacord Genuity。

Congrats on great year. On Caris Detect, I didn't -- I was trying to calculate PPV and some of the metrics here, it doesn't seem possible. data is pretty good. So I just wanted to ask if you could provide a little bit more color? I know it's in term, but still.

恭喜你度過了精彩的一年。在 Caris Detect 上，我沒有成功——我嘗試計算 PPV 和這裡的一些指標，但似乎無法實現。數據相當不錯。所以我想問一下，能否再補充一些細節？我知道這是學期內的，但還是…

And then just given [data sold], how does this validate the $3,500 price point? And what have folks like Everlywell comment things like that. And honestly, how do you think about COGS getting lower over time to, I don't know if you said that in the past? Thanks.

那麼，僅憑[已售出的數據]，如何驗證 3500 美元的價格？像Everlywell這樣的人竟然會發表這樣的評論。說實話，您覺得隨著時間推移，銷售成本（COGS）會降低嗎？我不知道您以前有沒有說過這句話？謝謝。

Yeah. So you can't really calculate PPV because it's still a case control study, where it's about one-third cancer patients to two-thirds controls. And PPV is dependent upon the patient population and the incidence rate. I mean, in that high-risk setting, right, having a 7% undiagnosed cancer rate is pretty high, and that's indicative of that enrichment that we did. And so we can certainly, I mean, you can kind of use that 7% to address the PPV calculation if you want to.

是的。所以你無法真正計算 PPV，因為它仍然是一項病例對照研究，其中大約三分之一是癌症患者，三分之二是對照組。PPV取決於患者群體和發病率。我的意思是，在那種高風險環境下，7%的未確診癌症率相當高，這表明我們所做的富集工作是有效的。所以，我們當然可以，我的意思是，如果你願意的話，你可以用這 7% 來解決 PPV 計算的問題。

In terms of the price point, we don't think the $3,500 is that high at all, given the fact that this test actually works and nothing else out there is able to detect early-stage cancers. I mean we have introduced and are introducing a new technology that has a high cost to it because it works really, really well. And so from our perspective, this is really more about the death of inferior technologies like methylation and being replaced by superior technologies like full genome sequencing.

就價格而言，考慮到這項測試確實有效，而且目前還沒有其他方法可以檢測出早期癌症，我們認為 3500 美元的價格一點也不算高。我的意思是，我們已經引入並正在引入一項新技術，這項技術成本很高，因為它效果非常好。因此，從我們的角度來看，這實際上更多的是關於甲基化等低階技術的消亡，以及全基因組定序等高階技術的取代。

All right. It makes sense on the PPV and the case control everything. Final one, maybe for Luke. On the EBITDA lack of EBITDA guidance, which I guess makes sense. But if you take out the true-ups for in '25, yes, maybe a few million in adjusted EBITDA. What's the reasoning to not provide a more refined range for this year? Is that going to be instead a kind of investment or other pipeline spending anything else?

好的。在付費觀看和案件控制方面，這樣做是合理的。最後一張，或許是給盧克的。關於 EBITDA 缺乏 EBITDA 指引這一點，我想這很合理。但如果剔除 2025 年的調整數據，是的，調整後的 EBITDA 可能會增加數百萬美元。今年為什麼不提供更精細的產品系列呢？那會是某種投資或其他類型的管道支出嗎？

Yeah. It's going to be all of the above effectively, because we have a huge opportunity, not just we obviously achieve one, we're so excited about an early detection, which is going to be massive, but also just because we're able to prove the profitability thesis, we want to utilize that going in. So like you brought up the point of like 2025, like we had $136 million adjusted EBITDA. Even if you exclude the prior year stuff, it's still above $100 million adjusted EBITDA. So I want to utilize that as we go into 2026, and that's kind of our focus.

是的。實際上，以上所有因素都會發揮作用，因為我們有一個巨大的機會，不僅因為我們顯然實現了早期檢測，我們對早期檢測感到非常興奮，這將意義重大，而且因為我們能夠證明盈利能力，所以我們想利用這一點。就像你提到的 2025 年，我們當時的調整後 EBITDA 為 1.36 億美元。即使排除上一年的數據，調整後的 EBITDA 仍超過 1 億美元。所以我想在進入 2026 年之際利用這一點，這也是我們工作的重點。

Now we are going to be diligent with that. We're not going to start burning like $250 million a year because we're in the position that we're in. but we're in a great position, and we're just going to use that. So I don't want to get tied down with guiding each quarter to a profitability metric.

現在我們要認真對待這件事。我們不會因為現在的處境就每年燒掉2.5億美元。但我們現在處境很好，我們會好好利用這一點。所以我不想被每季的獲利指標所束縛。

I'm showing no further questions at this time. Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.

我目前沒有其他問題要問。感謝您參加今天的會議。節目到此結束。您現在可以斷開連線了。