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    BLLN
    Earnings call· Dec 2025(Q4 FY25)

    BillionToOne Q4 FY25 earnings call BLLN

    Mar 4, 2026 Source

    Executive summary

    BillionToOne Q4 FY25 — Exceeds Rule of 100 with Strong Growth and Profitability

    BillionToOne delivered exceptional Q4 and full-year 2025 results, demonstrating robust growth and profitability that exceeded expectations, including prior guidance. The company's unique technology platform and differentiated products in prenatal and oncology drove significant increases in test volume and ASPs, while operational efficiencies improved margins. A key highlight was securing an in-network contract with UnitedHealthcare, expected to further accelerate growth and ASPs, positioning the company for a consequential 2026.

    Highlights

    5

    • Full year 2025 performance exceeded the 'Rule of 100' with 100% YoY revenue growth and 13% adjusted EBITDA margin.

    • Q4 2025 revenue grew 113% YoY to $96.1 million, driven by 47% test volume growth and 47% ASP growth.

    • Gross margins expanded by over 14 percentage points YoY to 71.4% in Q4 2025.

    • Achieved GAAP profitability in Q4 2025 with an 11% operating margin and 19% adjusted EBITDA margin.

    • Signed a landmark in-network contract with UnitedHealthcare, the largest commercial health insurer in the US.

    Concerns

    1

    • Mix shift towards oncology, which currently has lower margins than prenatal, will limit substantial near-term gross margin expansion.

    Guidance & targets

    3
    CategoryTargetConfidence
    Full-year 2026 Total Revenue
    $430 million to $445 million
    high materiality
    High
    Full-year 2026 GAAP Operating Income
    Positive
    high materiality
    High
    Q4 2025 Total Revenue (Previous Guidance)
    $84 million to $90 million
    medium materiality
    High

    Segment performance

    2
    SegmentRevenueYoYQoQMargin
    Prenatal
    Prenatal revenue continued to grow at a pace underscoring UNITY's differentiation.
    Clinical testing revenues: $86.1 millionClinical trial support and other services revenue: $800,000Annualized run rate: $348 million
    		$86.9 million98%——
    Oncology
    Oncology ramp driven by increasing adoption of Select and Response, commercial team execution, and MolDX coverage for Select. Growth was primarily from increased test volume.
    Annualized run rate: $36 million
    		$9.1 million736%29% (excluding true-up revenue)—

    Operational metrics

    41
    Rule of 100 performance
    Exceeded 100
    FY25

    Full year 2025 performance exceeded the Rule of 100.

    Test volume growth
    51%YoY
    FY25

    Driven by rapid increase in both test volume and ASPs.

    Overall ASP growth
    35%YoY
    FY25

    Driven by rapid increase in both test volume and ASPs.

    COGS per test decrease
    More than 10%
    FY25

    Even as oncology business built and processed more oncology tests with higher COGS.

    Gross margin improvement
    15 percentage points
    FY25

    As a result of decreased costs and increased efficiency.

    GAAP operating margin improvement
    36 percentage points
    FY25

    Achieved through AI and automation across functions.

    Contracted lives
    250 million
    FY25

    Clinical affairs and market access teams obtained Medicare coverage for Northstar Select and signed payer contracts.

    Annualized revenue run rate
    $384 million
    Q4 FY25

    Achieved exponential growth with the technology platform.

    Gross margin
    71.4%14 percentage points YoY increase
    Q4 FY25

    Expanded due to increased ASPs and reduced COGS per test.

    GAAP operating margin
    11%
    Q4 FY25

    Maintained strong profitability profile.

    Adjusted EBITDA margin
    19%
    Q4 FY25

    Maintained strong profitability profile.

    Cash and equivalents
    $496 million
    Q4 FY25

    Ended the year with a strong balance sheet.

    Term debt
    $50 million
    Q4 FY25

    Ended the year with a strong balance sheet.

    Total revenue growth
    113%YoY
    Q4 FY25

    Driven by rapid increases in tests delivered and ASPs across both product lines.

    Test volume growth
    47%YoY
    Q4 FY25

    Driven by rapid increases in tests delivered and ASPs across both product lines.

    Overall ASP growth
    47%YoY
    Q4 FY25

    Driven by rapid increases in tests delivered and ASPs across both product lines.

    Total tests delivered
    Approximately 170,00047% YoY increase
    Q4 FY25

    Driven by leadership in product innovation and growing commercial team.

    Overall ASP
    $561$60 QoQ increase
    Q4 FY25

    Reflects Medicaid states adopting PLA code, contracted payer base build-out, and growing oncology contribution.

    Overall ASP
    $49535% YoY increase
    FY25

    For the full year 2025, overall ASP increased.

    COGS per test
    $1614% YoY decrease
    Q4 FY25

    Commitment to continuous improvement to reduce COGS per test.

    Gross margin
    70%
    Q3 FY25

    Modest increase quarter-over-quarter from Q3.

    Net margin improvement
    29 percentage pointsYoY
    Q4 FY25

    Achieved GAAP profitability with year-over-year improvements.

    Operating margin improvement
    36 percentage pointsYoY
    Q4 FY25

    Achieved GAAP profitability with year-over-year improvements.

    True-up revenue
    $8.4 millionvs $1.1 million in Q4 FY24
    Q4 FY25

    Reflecting higher cash collection trends related to tests delivered in prior periods.

    True-up revenue
    $1.1 million
    Q4 FY24

    True-up revenue in the comparable prior year quarter.

    Operating expenses
    56%YoY increase
    Q4 FY25

    Total operating expenses increased to $58.3 million from $37.4 million in Q4 2024.

    R&D expense
    $14.3 millionvs $11 million in Q4 FY24
    Q4 FY25

    Within operating expenses.

    SG&A expense
    $44 millionvs $26.4 million in Q4 FY24
    Q4 FY25

    Within operating expenses.

    Operating profit margin
    5%
    FY25

    For the full year 2025.

    True-up revenue
    $17.1 millionvs $11.2 million in FY24
    FY25

    For the full year 2025.

    True-up revenue
    $11.2 million
    FY24

    For the full year 2024.

    Total tests delivered
    610,00051% growth
    FY25

    Number of tests delivered in 2025.

    Diluted shares outstanding
    52 million to 54 million
    Next several quarters

    For modeling purposes.

    Response V2 limit of detection
    0.01%
    Current

    Launched with a 0.01% limit of detection.

    UNITY unaided awareness
    30%
    Current

    Unaided awareness among providers.

    UNITY aided awareness
    50%
    Current

    Aided awareness among providers.

    UNITY market share (among aware providers)
    More than 50%
    Current

    If a provider knows about UNITY, the company has more than 50% market share.

    Medicaid states adopting Carrier PLA code (0449U)
    10
    FY25

    Each Medicaid addition can drive ASP increases and lead to further contracting with MCOs.

    Oncology test volume contribution (Northstar Response)
    Nearly 2/3
    Current

    Northstar Response accounts for nearly 2/3 of oncology test volume due to its repeat nature.

    Prenatal sales reps
    185vs ~150 currently
    End of FY26

    Planned growth to maintain quality and service.

    Oncology sales reps
    65vs 45 currently
    End of FY26

    Planned growth to maintain quality and service.

    Industry KPIs

    2
    MetricValueDetails
    Membership covered lives by line250 millionlives
    Adjusted EPS EBITDA leverage guidance$38.8 millionUSD

    Product announcements

    4
    ProductTypeDetails
    UNITY's expanded Red Blood Cell Fetal Antigen NIPTlaunch
    Platelet Fetal Antigen NIPTlaunch
    Northstar PGx (Pharmacogenomics add-on)launch
    Northstar Select CH (Clonal Hematopoiesis add-on)launch

    Deals & partnerships

    1
    UnitedHealthcareIn-network agreement

    Landmark moment for BillionToOne, as UnitedHealthcare is the largest commercial health insurer in the United States. This agreement is expected to accelerate contracting with other payers.

    Risks & headwinds

    3
    Mix shift to oncology limiting margin expansionNear-term

    Substantial near-term margin expansion will be limited.

    Mitigation: Encouraged by margin trajectory in both segments; expect to maintain gross margins near current levels.

    EMR integration as a blocker for health system adoptionLikely 6 months from now for Epic Aura integrations.

    Not reflected in 2026 guidance.

    Mitigation: Working towards integration; adoption in a single health system can be a significant upside to projections.

    Competition in oncology therapy selection and response monitoringCurrent

    Not seeing any impact from competition so far.

    Mitigation: Differentiated products (50% more actionable variants, high specificity with CH add-on) and a 'flywheel effect' where satisfied physicians become advocates.

    What to watch in Q1 FY26

    5

    Health system adoptions

    H2 FY26
    CurrentClinical buy-in, EMR integration pending
    Target1-3 health systems starting to come in

    Why it matters

    Each health system can contribute 10,000-30,000 tests annually, representing significant upside not in current guidance.

    Given that this is not completely under our control, right? This is -- we first need to integrate with Epic and then we need to integrate with each health system, and that can take time. We haven't incorporated any of these uplifts into our test numbers for 2026. That said, given what we are seeing here, I think, especially in the second half of the year, there can be opportunities for 1, 2, 3 of these health systems to start coming in.

    Q&A highlights

    9

    Can you discuss the current awareness of UNITY among NIPT providers and how you plan to increase it? Also, elaborate on conversations with health systems regarding driving uptake.

    Unaided awareness of UNITY is around 30%, aided around 50%. Among providers who know UNITY, the company has over 50% market share. Awareness will increase through sales team expansion, full US coverage, publications, and guideline changes. MFMs have significant influence, and their advocacy can drive OBs to use UNITY for frontline screening, especially in health systems where they work closely.

    “what we see in our own data that around -- depending on whether it is aided or unaided recall, at least 50% of providers do not know anything about UNITY. So that actually is a remarkable outcome that of the providers who know about UNITY, we actually have more than 50% market share or so.”

    asked by Andrew Brackmann · answered by Oguzhan Atay

    2 min read5 chapters

    Detailed Narrative

    01

    Revolutionary Technology Platform and Product Innovation

    BillionToOne's core differentiation stems from its patented QCT (Quantitative Counting Templates) technology, enabling single-molecule level sensitivity and precision. This platform supports category-defining products like UNITY in prenatal care, offering comprehensive screening, and Northstar Select/Response in oncology, which detects 50% more actionable variants and provides real-time treatment monitoring. The company continues to leverage this platform for new product development and enhancements.

    02

    Strong Commercial Momentum and Payer Access Expansion

    The company reported a record number of new active ordering providers in Q4 2025, setting a strong foundation for Q1 2026. This commercial success is bolstered by an expanding sales team and significant progress in market access, including signing 44 payer contracts in 2025, adding over 25 million lives, and reaching 250 million contracted lives in the US. A landmark in-network contract with UnitedHealthcare is expected to further accelerate test volumes and ASPs by reducing friction for physicians and patients.

    03

    New Product Launches and Pipeline Advancements

    Post-quarter, BillionToOne launched several key products: UNITY's expanded Red Blood Cell Fetal Antigen NIPT and the first-and-only Platelet Fetal Antigen NIPT, addressing severe conditions like HDFN and FNAIT. In oncology, Northstar PGx for pharmacogenomics and Northstar Select CH for clonal hematopoiesis were introduced as add-ons to Northstar Select, enhancing therapy selection accuracy. The company also submitted a comprehensive MolDX coverage dossier for Northstar Response, aiming for coverage by year-end.

    04

    Operational Efficiency and Margin Expansion

    BillionToOne achieved significant operational improvements, with COGS per test decreasing by over 10% for the full year 2025, contributing to a 15 percentage point improvement in gross margins. Q4 2025 gross margins reached 71.4%, up 14.3 percentage points YoY. The company also saw a 36 percentage point improvement in GAAP operating margin for FY25, driven by increasing sales efficiency, rising ASPs, and a relentless focus on productivity through AI and automation.

    05

    Health System Opportunities and EMR Integration

    The company sees significant upside potential from health system adoptions, with each system potentially contributing 10,000 to 30,000 tests annually. While clinical buy-in exists, EMR integration (specifically Epic Aura) remains a blocker, with integrations likely 6 months away. These potential contributions are not yet reflected in the 2026 guidance, indicating a conservative outlook and future growth drivers.

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