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    CAI
    Earnings call· Dec 2025(Q4 FY25)

    Caris Life Sciences Q4 FY25 earnings call CAI

    Feb 26, 2026 Source

    Executive summary

    Caris Life Sciences Q4 FY25 — Record Revenue, Strong Profitability, and Early Detection Progress

    Caris Life Sciences concluded its first year as a public company with a record-breaking Q4 FY25, driven by robust molecular profiling revenue growth and significant margin expansion. The company achieved strong profitability, generating positive adjusted EBITDA and free cash flow for the third consecutive quarter, bolstering its balance sheet. Strategic investments are planned for 2026 to expand the commercial sales force and advance its differentiated pipeline, particularly the Caris Detect early cancer detection test, while maintaining financial discipline.

    Highlights

    5

    • Total revenues increased 125% year-over-year to $293 million in Q4 FY25.

    • Molecular profiling services revenues increased 199% year-over-year to $282 million in Q4 FY25.

    • GAAP gross margins improved to 75% in Q4 FY25, up from 54% in Q4 FY24.

    • Generated positive GAAP net income of $82 million and adjusted EBITDA of $106 million in Q4 FY25.

    • Cash on hand grew to over $800 million, an increase of $43 million in the quarter.

    Concerns

    2

    • Pharma R&D Services revenues were down year-over-year for FY25, though Q4 showed progress with new deals.

    • Blood ASP guidance for FY26 is $2,400-$2,500, reflecting a cautious outlook compared to Q4 FY25 actuals of just under $2,800.

    Guidance & targets

    11
    CategoryTargetConfidence
    Total revenue
    $1.0 billion to $1.02 billion
    high materiality
    High
    Molecular profiling growth
    21% to 22%
    medium materiality
    High
    Therapy selection volume growth
    approximately 20%
    medium materiality
    High
    Tissue ASP
    approximately $4,200
    medium materiality
    High
    Blood ASP
    $2,400 to $2,500
    medium materiality
    Medium
    Pharma and research revenue
    $75 million to $85 million
    medium materiality
    High
    GAAP operating expenses
    $590 million to $595 million
    medium materiality
    High
    Adjusted EBITDA
    positive
    high materiality
    High
    Free cash flow
    positive
    high materiality
    High
    CapEx
    approximately $60 million
    medium materiality
    High
    Caris Detect launch
    Q2 2026
    high materiality
    High

    Segment performance

    2
    SegmentRevenueYoYQoQMargin
    Molecular Profiling Services
    Strong performance driving total revenue growth.
    		$282 million199%——
    Pharma R&D Services
    Making important progress in CDx data discovery, including the Genentech Discovery deal.
    		$10.8 million———

    Operational metrics

    64
    Clinical cases completed
    200,000
    FY25

    Approximately 200,000 individual cases completed.

    Molecular data set
    1 million
    Q4 FY25

    Molecular data set now exceeds 1 million profiled cases.

    Molecular data set markers
    50 billion
    Q4 FY25

    Data set includes more than 50 billion molecular markers.

    Exomes in data set
    627,000
    Q4 FY25

    Data set features 627,000 exomes.

    Transcriptomes in data set
    678,000
    Q4 FY25

    Data set features 678,000 transcriptomes.

    Total revenues growth
    125%YoY
    Q4 FY25

    Driven by volume growth of 20% and a 150% increase in clinical ASP.

    Clinical case volume growth
    20%
    Q4 FY25

    Driving total revenue growth.

    Clinical ASP increase
    150%YoY
    Q4 FY25

    Driving total revenue growth.

    GAAP gross margins
    75%up from 54% in Q4 FY24
    Q4 FY25

    Significant sequential increase from 68% in Q3 FY25.

    GAAP net income
    $82 million
    Q4 FY25

    Generated with strong revenue performance and operating leverage.

    Adjusted EBITDA
    $106 million
    Q4 FY25

    Third straight quarter of positive adjusted EBITDA.

    Cash on hand
    $800 millionincrease of $43 million
    Q4 FY25

    Balance sheet continues to strengthen.

    Molecular profiling revenues
    $766.7 million120% YoY
    FY25

    Main driver of 2025 growth, due to ASP uplift and volume growth.

    Clinical case volumes
    199,30022% YoY
    FY25

    Growth in clinical case volumes.

    Average sales price increase
    79%YoY
    FY25

    Reflecting market access and billing team's strong execution.

    Tissue ASP growth
    83%
    Q4 FY25

    Increased to over $4,000, driven by My Cancer Seek launch.

    Blood ASP growth
    69%
    Q4 FY25

    Increased to just under $2,800, driven by new PLA code and improved payment for Caris Assure.

    Blood ASP
    $2,800just under
    Q4 FY25

    Driven by new PLA code and improved payment for Caris Assure.

    Clinical case volume growth
    18%YoY
    Q3 FY25

    Sequential improvement to 20% in Q4 FY25.

    Caris Assure growth
    59%YoY
    Q4 FY25

    Continuing to gain traction.

    Oncologists reached
    6,000
    Q4 FY25

    Consistently reaching over 6,000 oncologists across the country.

    EHR integrations
    3,100
    Q4 FY25

    Approximately 75% of orders come in electronically from these sites.

    ACHIEVE-1 total samples
    2,122
    Interim readout

    Total samples included in the interim readout.

    ACHIEVE-1 cancer samples
    617
    Interim readout

    Cancer samples spanning stages 1 through 4.

    ACHIEVE-1 no known cancer samples
    1,505
    Interim readout

    Patients with no known cancer at the time of blood draw.

    ACHIEVE-1 normal cohort follow-up
    22.5%
    Interim readout

    Percentage of normal cohort with at least 1 year of follow-up data.

    ACHIEVE-1 asymptomatic screening population
    121
    Interim readout

    Individuals with no significant risk factors for cancer and at least 1 year of follow-up.

    ACHIEVE-1 subsequent cancer diagnosis in total cohort
    7%
    Interim readout

    Percentage of patients in the total cohort who had a subsequent diagnosis of cancer, indicating the control population is truly high risk.

    ACHIEVE-1 sensitivity Stage 1
    56.8%
    Interim readout

    Sensitivity for Stage 1 cancers in ACHIEVE-1 interim results.

    ACHIEVE-1 sensitivity Stage 2
    70.1%
    Interim readout

    Sensitivity for Stage 2 cancers in ACHIEVE-1 interim results.

    ACHIEVE-1 sensitivity Stage 3
    77%
    Interim readout

    Sensitivity for Stage 3 cancers in ACHIEVE-1 interim results.

    ACHIEVE-1 sensitivity Stage 4
    99.1%
    Interim readout

    Sensitivity for Stage 4 cancers in ACHIEVE-1 interim results.

    ACHIEVE-1 sensitivity Stage 1 & 2 combined
    63.1%
    Interim readout

    Combined sensitivity for Stage 1 and 2 cancers.

    ACHIEVE-1 sensitivity (Breast cancer)
    53%
    Interim readout

    Sensitivity for breast cancer in ACHIEVE-1 interim results.

    ACHIEVE-1 sensitivity (Valve cancer)
    62.2%
    Interim readout

    Sensitivity for valve cancer in ACHIEVE-1 interim results.

    ACHIEVE-1 sensitivity (Prostate cancer)
    78.9%
    Interim readout

    Sensitivity for prostate cancer in ACHIEVE-1 interim results.

    ACHIEVE-1 sensitivity (Uterus cancer)
    73.7%
    Interim readout

    Sensitivity for uterus cancer in ACHIEVE-1 interim results.

    ACHIEVE-1 sensitivity (Lung cancer)
    86.7%
    Interim readout

    Sensitivity for lung cancer in ACHIEVE-1 interim results.

    ACHIEVE-1 sensitivity (Pancreas cancer)
    71.4%
    Interim readout

    Sensitivity for pancreas cancer in ACHIEVE-1 interim results.

    ACHIEVE-1 sensitivity (Head and Neck cancer)
    100%
    Interim readout

    Sensitivity for head and neck cancer in ACHIEVE-1 interim results.

    ACHIEVE-1 specificity screening population
    99.1%
    Interim readout

    Specificity in the screening population with follow-up data, no symptoms, no history, no family history of cancer, and no subsequent diagnosis within 2 years.

    ACHIEVE-1 specificity higher-risk normal population
    95.3%
    Interim readout

    Specificity in the higher-risk normal population, where 7% of undiagnosed subjects were subsequently diagnosed with cancer.

    ACHIEVE-1 AUC
    0.90
    Interim readout

    Overall model performance measured by AUC.

    ACHIEVE-1 blinded holdout validation cohort
    865
    Interim readout

    Approximately 865 samples held out for independent testing.

    Chroma Seq coverage
    200xgreater than
    Current

    Running greater than 200x coverage across the whole genome sequencing.

    Chroma Seq reads per patient
    1.6 billion
    Current

    Assay designed to detect full range of clinically relevant genomic alterations.

    Total revenue growth
    97%YoY
    FY25

    Exceptional organic performance across the business for the full year.

    Prior year revenue benefit
    $33.6 million
    FY25

    Additional revenue from exceeding accruals related to 2024 and prior year cases.

    Tissue ASP
    $3,876
    FY25

    Resulted from favorable payer response and additional revenue exceeding prior accruals.

    Blood ASP
    $2,500just above
    FY25

    Resulted from favorable payer response and additional revenue exceeding prior accruals.

    MI Cancer Seek tissue volume
    70%greater than
    FY25

    Represented greater than 70% of tissue volume for the full year 2025, and over 75% for Q4.

    Tissue growth rate
    16%up from 2024
    FY25

    Increased for the full year.

    Molecular profiling gross margin (GAAP)
    66%
    FY25

    Improved gross margin for the full year.

    Molecular profiling gross margin (excluding prior year accruals)
    64%
    FY25

    Slightly below GAAP gross margin when excluding additional revenue from prior year accruals.

    Adjusted EBITDA
    $138 million
    FY25

    Full year 2025 adjusted EBITDA.

    Sales force size
    250
    Q4 FY25

    Approximately 250 salespeople at JPMorgan, with a plan to increase to about 300.

    Sales force increase target
    20% to 25%
    FY26

    Target to increase sales force to about 300 people.

    Sales and marketing OpEx increase
    30%
    FY26

    Step-up in sales and marketing operating expenses.

    R&D OpEx increase
    30%
    FY26

    Step-up in R&D operating expenses, supporting ACHIEVE-2 data.

    CapEx
    $16 million
    2025

    Capital expenditure for 2025.

    Tissue ASP goal
    $3,600
    Q4 FY25

    Goal achieved for Q4 tissue ASP, with expectation to reach $4,000 for Q1 2026.

    Caris Detect price point
    $3,500
    Current

    Management believes this price point is not high given the test's efficacy and superiority.

    ACHIEVE-2 total subjects
    25,000
    Ongoing

    Total subjects planned for the ACHIEVE-2 study, including precancerous components.

    ACHIEVE-2 samples in-house
    18,000about
    Ongoing

    Approximately 18,000 samples currently in-house for ACHIEVE-2.

    Product announcements

    6
    ProductTypeDetails
    Caris Detectlaunch
    Caris Chroma Seqlaunch
    Caris MI Claritylaunch
    Caris MRD tumor-naiveroadmap
    Caris MRD tumor-informedroadmap
    AI signatures on molecular tumor board reportslaunch

    Deals & partnerships

    3
    GenentechDiscovery deal and CDx collaboration

    Announced in December, includes a Discovery deal and a CDx collaboration.

    Pharma partner (unnamed)CDx collaboration

    One of a couple of CDx collaborations that was completed, not publicly announced at the partner's request.

    EverlywellPartnership for Caris Detect field-based sales force

    Partnership announced in January to support the field-based sales force for Caris Detect.

    Risks & headwinds

    4
    Pharma R&D Services revenue declineFY25

    down year-over-year

    Mitigation: Progress in Q4 with Genentech deal and CDx collaboration; expect to build momentum into 2026.

    Pacing of new sales force productivityH1 2026

    New reps typically take ~6 months to become productive.

    Mitigation: Volume guidance for 2026 does not assume a big uptick from new reps until H2; expense incorporated.

    MolDX additional data request for Caris MRD tumor-naiveOngoing

    Additional data requested

    Mitigation: Working on creating and compiling the requested data.

    Ethical quandary of offering breast-only test for early detectionOngoing

    Not quantified

    Mitigation: Would not want to not report other cancers found if a breast-only test were offered.

    What to watch in Q1 FY26

    5

    ACHIEVE-1 blinded holdout validation readout

    Q1 2026
    CurrentCurrently in process
    TargetSupport these results

    Why it matters

    This is the next key catalyst for the Caris Detect early cancer detection test, validating the interim results.

    That blinded validation is currently in process, and we expect to support these results in Q1.

    Q&A highlights

    6

    Can you provide a breakdown of the 20% volume growth between tissue and blood, and give color on Q1 revenue pacing?

    The 20% volume growth is expected to be low teens for tissue and high 50s/low 60s for blood, similar to Q4 FY25. Q1 total revenue is projected to be in the 70% to 74% growth range.

    “Yes. 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.”

    asked by Dan Brennan · answered by Unknown Executive

    2 min read5 chapters

    Detailed Narrative

    01

    Molecular Data Set & AI Innovation

    Caris' molecular data set has surpassed 1 million profiled cases and now includes over 50 billion molecular markers, making it a significant clinical genomic resource. This extensive data, derived from whole exome and whole transcriptome sequencing, is foundational for internal product development and AI models, enabling the identification of subtle biological signals associated with early-stage cancers. The company emphasizes the intersection of molecular science and AI as a key driver of technological innovation.

    02

    Commercial Strategy and Expansion

    For 2026, Caris plans significant investments in its commercial channel, including expanding its sales force by 20-25% to approximately 300 people, with a focus on liquid specialist teams. The strategy also involves strengthening product messaging, emphasizing the differentiation of its technology, and elevating medical education. These initiatives aim to broaden reach, deepen relationships with over 6,000 oncologists, and streamline the ordering process across 3,100 EHR-integrated clinical sites.

    03

    ACHIEVE-1 Interim Results for Caris Detect

    The interim readout of the ACHIEVE-1 study for Caris Detect, a whole genome sequencing-based MSAD blood test, showed strong performance. It reported 63.1% sensitivity for Stage 1 and 2 cancers combined, and 99.1% specificity in the asymptomatic screening population. The study included 2,122 samples across 35 cancer types, leveraging ultra-deep whole genome sequencing and AI models built on Caris' vast molecular data set. The blinded holdout validation is expected in Q1 2026.

    04

    Pipeline Updates and Development

    Caris provided updates on several pipeline products: Caris Chroma Seq for hematological malignancies (awaiting coverage/pricing), Caris MI Clarity for breast cancer (digital AI-only version expected first), Caris MRD tumor-naive for colorectal cancer (requiring additional MolDX data), and Caris MRD tumor-informed for pan-tumor applications (development initiated). The company also launched five new AI signatures on its molecular tumor board reports for various cancers, enhancing therapeutic guidance.

    05

    Financial Discipline and Reinvestment Strategy

    Having demonstrated its model's self-sufficiency with positive adjusted EBITDA ($138 million) and free cash flow ($67 million) for FY25, Caris plans to reinvest from this position of strength in 2026. The strategy involves funding pipeline advancements and commercial infrastructure expansion, while committing to remain positive in adjusted EBITDA and free cash flow. This approach prioritizes long-term value creation over optimizing for peak short-term margins.

    AI-generated summary of the company’s earnings call. Not investment advice.