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    NTRA
    Earnings call· Sep 2025(Q3 FY25)

    Natera, Inc. NTRA

    Nov 6, 2025 Source

    Executive summary

    Natera Q3 FY25 — Record Revenue and Signatera Growth Drive Raised Guidance

    Natera delivered a strong third quarter, marked by record revenue and significant growth in its Signatera MRD tests, leading to a substantial increase in full-year financial guidance. The company is actively expanding its Fetal Focus product and advancing its early cancer detection program, while also preparing for numerous MolDx submissions to broaden reimbursement coverage. Management anticipates continued strong performance into the next fiscal year with disciplined OpEx growth.

    Highlights

    5

    • Generated $592 million in revenue, up 35% year-over-year.

    • Processed 202,000 clinical MRD tests, a record increase of 21,500 units sequentially.

    • Achieved a gross margin of 64.9%, nearly 1.5 percentage points higher than Q2 FY25.

    • Significantly increased 2025 revenue guidance to $2.18 billion - $2.26 billion.

    • Substantially raised free cash flow generation guidance to roughly $100 million for FY25.

    Concerns

    1

    • Modestly bumped up OpEx guidance for FY25 due to approximately $60 million in one-time expenses and increased R&D for MolDx submissions and the FIND study.

    Guidance & targets

    9
    CategoryTargetConfidence
    Full-year 2025 Revenue
    $2.18B - $2.26B
    high materiality
    High
    Full-year 2025 Gross Margin
    62% - 64%
    high materiality
    High
    Full-year 2025 Free Cash Flow
    Roughly $100M
    high materiality
    High
    Full-year 2025 Operating Expenses (OpEx)
    Modestly bumped up
    medium materiality
    Medium
    2026 OpEx Growth
    Something more like in the 10% range
    medium materiality
    Medium
    2026 Women's Health & Organ Health Volume Growth
    Similar number of growth units as 2025
    medium materiality
    Medium
    2026 Signatera Unit Growth
    Last 4 quarters rolling average as a good goal
    high materiality
    Medium
    2026 Signatera ASP Growth
    Perhaps the $50 range through the course of the year
    medium materiality
    Medium
    2026 Women's Health & Organ Health ASPs
    Stable
    low materiality
    Medium

    Segment performance

    3
    SegmentRevenueYoYQoQMargin
    Women's Health
    Solid sequential quarterly growth, driven in part by interest in Fetal Focus and new commercial activity. ASPs showed sequential improvement.
    Sequential improvement in ASP: Q3 vs Q2
    		————
    Organ Health
    Very strong performance with both greenfield and competitive wins. ASPs showed sequential improvement.
    Sequential improvement in ASP: Q3 vs Q2
    		————
    Oncology (Signatera)
    Posted another record quarter for unit growth, representing 56% year-on-year growth, the fastest in 2025. Driven by groundbreaking clinical data and customer experience. ASPs are approximately $1,200 and showed sequential improvement.
    Clinical MRD tests processed: 202,000Signatera growth units: 21,000Latitude growth units: a few hundredSignatera ASP: ~$1,200
    		—56%——

    Operational metrics

    12
    Gross Margin (ex-true-ups)
    61.3%Up 1 percentage point vs Q2 FY25
    Q3 FY25

    Grew a full percentage point compared to Q2 FY25, driven by better ASPs and lean COGS.

    Days Sales Outstanding (DSOs)
    49 daysDown from 57 days in Q2 FY25
    Q3 FY25

    Posted a new record low for DSOs, indicating accelerated cash collections.

    Cash and Investments Balance
    Above $1B
    Q3 FY25

    Balance sheet remains pristine with no permanent debt, pushed by cash flows from operations.

    Revenue True-ups
    $55M
    Q3 FY25

    As cash collections continue to accelerate.

    One-time OpEx Expenses
    $60M
    FY25

    Accumulated over the course of the year, contributing to the modest bump in OpEx guidance.

    Gross Profit Opportunity from MolDx Submissions
    $250M - $300M
    Run rate

    Expected gross profit based on current run rate from the 7 new MolDx submissions planned by year-end.

    SG&A
    Slightly down sequentiallyvs Q2 FY25
    Q3 FY25

    Reflects scaled commercial team and revenue cycle operations after prior investments.

    Signatera New Patient Starts
    StrongSimilar to Q2 FY25 record levels
    Q3 FY25

    Physicians continue to use the test for ongoing monitoring, fueled by clinical data. Q3 saw similar record levels of new patient starts as Q2.

    MolDx Submissions
    7
    By year-end 2025

    Planned submissions for new Signatera indications to expand coverage.

    Fetal Focus Panel Expansion
    Over 20 genesExpanded from 5 genes
    Q4 FY25

    Expansion of the single-gene NIPT for inherited conditions, leveraging the EXPAND trial.

    PROCEED-CRC Advanced Adenoma Sensitivity
    22.5%Up from 18% in earlier 2025 pilot data
    Most recent analysis

    Derived from 1,400 sequential participants with clinical outcomes in the PROCEED-CRC study, showing improved detection rates for precancerous lesions.

    FIND-CRC Enrollment Target
    25,000
    Target

    Study targeting average-risk asymptomatic screening participants to generate regulatory-grade evidence for early cancer detection.

    Industry KPIs

    6
    MetricValueDetails
    Launch access metricsGreen shoots
    Pipeline read out calendarVEGA trial readout likely in 2027
    Product franchise net sales$592MUSD
    Regulatory approvals filings7 new MolDx submissionssubmissions
    Prescription volume new starts21,500 unitsunits
    Clinical trial efficacy safety dataIMvigor011: 41% improved overall survival%

    Product announcements

    1
    ProductTypeDetails
    Fetal Focusexpansion

    Risks & headwinds

    2
    One-time OpEx expensesFY25

    $60M

    Mitigation: These do not repeat every quarter; SG&A was flat to down sequentially in Q3, indicating scaling efficiency.

    Modest headwind from ADLT resetNext year (FY26)

    Modest

    Mitigation: Factored into the preliminary ASP forecast for Signatera, with efforts in biomarker states and MolDx submissions aiming to offset and drive better results.

    What to watch in Q4 FY25

    4

    Signatera Unit Growth

    Next quarter (Q4 FY25) and FY26
    Current21,500 units sequential growth in Q3 FY25
    TargetMaintain or exceed the last 4 quarters rolling average (approx. 18,000 units sequential growth)

    Why it matters

    Signatera unit growth is a key driver of revenue and market penetration, indicating continued adoption and momentum.

    And for Signatera units, we continue to think about the last 4 quarters rolling average as a good goal for unit growth over the course of the year.

    Q&A highlights

    5

    Why is now the right time for the Fetal Focus expansion, what was the feedback on the 5-gene panel, and how is reimbursement being considered for the 20-gene panel?

    The 5-gene panel received great feedback, and R&D progress allowed for the planned expansion to 20 genes. The EXPAND clinical trial, a gold standard for prospective sample collection and diagnostic outcomes, is ongoing and expected to be defining for the space. Reimbursement was not directly addressed for the 20-gene panel, but the company emphasized the clinical need and the strength of their technology and trials.

    “We're also excited about the EXPAND clinical trial. This is something that we started several years ago, if you go back and you take a look. This type of trial is really the gold standard where we're prospectively collecting blood tubes and then collecting diagnostic outcomes on both positive and negative samples effectively on all the pregnant patients that enroll into the study.”

    asked by Noah Kava · answered by Steve Chapman

    2 min read5 chapters

    Detailed Narrative

    01

    Q3 FY25 Performance Highlights

    Natera reported a strong Q3 FY25, with revenue reaching $592 million, a 35% increase year-over-year. Clinical MRD tests processed totaled 202,000, marking a sequential growth of 21,500 units, setting a new record for Signatera. Gross margin improved significantly to 64.9%, up 1.5 percentage points from Q2, driven by better ASPs and lean COGS. The company also achieved a record low for Days Sales Outstanding (DSOs) at 49 days.

    02

    Fetal Focus Product Expansion

    The Fetal Focus single-gene NIPT, initially launched in August 2025 with a 5-gene panel, is being expanded to cover over 20 common genes by the end of the year. This expansion leverages prospectively collected samples from the EXPAND trial, which enrolled over 1,700 high-risk pregnancies. The test aims to assess fetal DNA for inherited conditions when the father is unavailable for screening, utilizing proprietary LinkedSNP technology for improved detection of challenging homozygous cases.

    03

    Signatera Clinical Data and Reimbursement Progress

    Significant clinical data for Signatera was presented at ESMO, including blockbuster readouts for muscle-invasive bladder cancer from the IMvigor011 and CheckMate 274 trials, published in the New England Journal of Medicine and Annals of Oncology, respectively. This data provides Level 1A evidence for Signatera's role in guiding treatment post-radical cystectomy, showing improved overall survival for MRD-positive patients receiving immunotherapy. The company is also seeing 'green shoots' in biomarker state reimbursement for commercial volumes, contributing to Signatera's ASP growth.

    04

    Early Cancer Detection (ECD) Program Advancement

    Natera is making significant investments in early cancer detection, particularly for colorectal cancer (CRC). The PROCEED-CRC study, a U.S. prospective study, reported 22.5% sensitivity and 91.5% specificity for advanced adenomas, a step up from earlier pilot data. This performance, even with smaller lesion sizes, provides confidence for the FDA-grade FIND-CRC validation study, which aims to enroll 25,000 average-risk adults and began enrollment in May 2025, with targets expected to be met over 18 months.

    05

    Strategic Investments and Operational Efficiency

    The company is strategically increasing R&D to support 7 new MolDx submissions by year-end, which could generate $250 million to $300 million in gross profit. Investments are also directed towards definitive Signatera clinical trials and the FDA-enabling FIND study. SG&A was flat to down sequentially, reflecting scaled commercial teams and revenue cycle operations. Natera expects limited OpEx growth of approximately 10% in 2026, with revenues growing much faster, driving continued margin improvement and sustainable free cash flow generation.

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