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    BLLN
    Earnings call· Jun 2026(Q2 FY26)

    BillionToOne Q2 FY26 earnings call BLLN

    Aug 5, 2026 Source

    Executive summary

    BillionToOne Q2 FY26 — Strong Growth and Profitability Driven by Product Innovation and Commercial Expansion

    BillionToOne delivered a strong quarter, showcasing robust revenue and volume growth alongside impressive profitability and margin expansion, driven by its innovative QCT technology platform. The company continues to invest strategically in product development and commercial expansion, including new prenatal and oncology offerings and EMR integration, positioning for accelerated growth in the coming quarters. Despite some short-term impacts from true-up timing and held claims, management remains confident in its long-term trajectory and ability to maintain profitability.

    Highlights

    5

    • Total revenue grew 64% year-over-year to $109.4 million.

    • Total test volume increased 35% year-over-year to approximately 196,000 tests.

    • Gross margin expanded to 70.5%, up 5 percentage points year-over-year.

    • Achieved GAAP operating income of $5.5 million, representing a 5% operating margin and 15% adjusted EBITDA margin.

    • Cash and equivalents increased to $549 million at quarter-end.

    Concerns

    3

    • Overall ASP declined $20 sequentially due to true-up timing, though ex-true-up ASP increased $15 quarter-over-quarter.

    • Over $10 million in claims were held awaiting in-network implementation, temporarily impacting cash collections and realized ASPs.

    • Accelerated hiring of 70 sales representatives in H1 FY26 had some impact on short-term sales productivity.

    Guidance & targets

    6
    CategoryTargetConfidence
    Full-year 2026 total revenue
    $450 million to $465 million
    high materiality
    High
    Full-year 2026 profitability
    Similar to current levels
    high materiality
    High
    MolDX Medicare coverage for Northstar Response
    Expected by the end of this year
    high materiality
    High
    Highly sensitive tumor-naive MRD launch
    By the end of the year
    high materiality
    High
    Oncology production lab production start
    By the end of 2027
    medium materiality
    High
    Gross margin
    At or above 70%
    high materiality
    High

    Segment performance

    2
    SegmentRevenueYoYQoQMargin
    Prenatal
    Revenue driven by strong commercial execution and rising ASPs. Ex-true-up revenue increased by approximately $4.5 million sequentially, representing 5% growth.
    		$95.8 million56%——
    Oncology
    Revenue grew nearly 3x year-over-year, exceeding expectations. All sequential growth was attributed to test volume increases, as ASPs remained stable.
    Annualized revenue run rate: ~$55 million
    		$13.7 million176%——

    Operational metrics

    27
    Annualized revenue run rate
    $438 millionfrom 0 in 6 years
    Q2 FY26

    Rapid scaling since inception.

    Gross margin
    70.5%up 5 percentage points YoY
    Q2 FY26

    Driven by higher ASPs despite mix shift towards lower-margin oncology tests.

    Adjusted EBITDA margin
    15%
    Q2 FY26

    Achieved alongside strong growth and GAAP profitability.

    Cash and equivalents
    $549 million
    end of Q2 FY26

    Strong balance sheet position for future growth.

    Total test volume
    196,000up 35% YoY, up ~8,000 sequentially
    Q2 FY26

    Growth in line with expectations for prenatal and above for oncology.

    Sales representatives added
    70ahead of plan
    H1 FY26

    Accelerated hiring to capitalize on future opportunities.

    Oncology lab capacity
    5,000 tests per day
    Future

    New 62,000 sq ft dedicated facility to support scaling oncology volume.

    Overall ASP
    $551up 21% YoY
    Q2 FY26

    Increased due to record number of payer contracts signed.

    Sequential ASP decline
    $20
    Q2 FY26 vs Q1 FY26

    Attributed to true-up timing differences.

    True-up revenue
    $2.8 millionvs $9.2M in Q1 FY26 and $2.1M in Q2 FY25
    Q2 FY26

    Lower sequentially due to timing and held claims.

    True-up revenue per test
    $14vs $49 in Q1 FY26
    Q2 FY26

    Reflects lower true-up revenue in the quarter.

    Overall ASP ex-true-up sequential increase
    $15
    Q2 FY26 vs Q1 FY26

    Underlying ASP trend continued to increase sequentially.

    Claims held
    >$10 million
    Q2 FY26

    Held due to waiting for in-network implementation of codes by national payers.

    Overall COGS per test
    $161up from $152 in Q1 FY26 and $156 a year ago
    Q2 FY26

    Increase driven by mix shift towards oncology, which has higher COGS.

    Oncology COGS reductions
    >10%QoQ
    Q2 FY26

    Achieved despite overall COGS per test increase due to mix.

    Operating expenses increase
    59%YoY
    Q2 FY26 vs Q2 FY25

    Increase driven by continued investment in commercial and R&D organizations.

    Gross margin ex-true-up
    around 70%stable
    last 4 quarters

    Remarkably stable despite significant mix shift towards oncology.

    Long-term gross margin target
    70% to 80%
    long term

    Every product designed to generate this margin in the long term.

    Prenatal revenue ex-true-up sequential growth
    $4.5 million5% growth sequentially
    Q2 FY26 vs Q1 FY26

    Underlying growth in prenatal revenue when excluding true-up timing.

    Northstar Origin top 3 accuracy
    91%
    Current

    Accuracy in identifying tissue of origin using QCT-based molecular counting of methylation.

    Northstar Origin top 1 accuracy
    86%
    Current

    Accuracy in identifying tissue of origin using QCT-based molecular counting of methylation.

    Oncology liquid biopsy QC failure rate
    <1%vs 15%-30% typical of tissue sequencing assays
    Current

    Demonstrates high reliability of assays.

    MTAP loss prevalence
    ~15%
    Current

    MTAP loss is a target of several promising ongoing clinical trials.

    Cancer of unknown primary prevalence
    ~3%
    Current

    Can reach 10% in community oncology settings with uncertain diagnosis.

    Epic Aura integration speed
    <5 monthsrecord speed for any laboratory
    Current

    Time taken to launch on Epic's Aura platform.

    First Aura health system integration speed
    2 weeks
    Current

    Time from start to first test order for a health system.

    Health system test volume potential
    1,000 to 3,000
    per quarter

    Potential incremental test volume once a health system is onboarded.

    Industry KPIs

    1
    MetricValueDetails
    Adjusted EPS EBITDA leverage guidance15%%

    Product announcements

    4
    ProductTypeDetails
    Unity Confirmlaunch
    Unity fetal risk screenexpansion
    Northstar Selectexpansion
    Northstar Originlaunch

    Risks & headwinds

    4
    Short-term sales productivity impact from new hiringShort-term

    Not quantified, but noted as 'some impact'

    Mitigation: Expect hiring to translate into faster growth exiting the year and into early next year as representatives become fully productive and penetrate health systems.

    Delayed claims processing and cash collectionsSecond half of the year

    More than $10 million of claims held

    Mitigation: Expects resolution through the second half of the year as claims are processed and paid. Maintaining conservative guidance until clearer.

    Health system EMR integration timelineNext 2-4 quarters

    2 to 4 quarters

    Mitigation: Company has record-speed integration with Epic Aura, but individual health systems' IT roadmaps delay full conversion. Actively working to convince health systems to prioritize integrations.

    Overall COGS per test increase due to mix shiftGradually over time

    Overall COGS per test was $161, up from $152 in Q1 and $156 a year ago

    Mitigation: Underlying operational discipline is intact (prenatal COGS flat, oncology COGS down >10% QoQ). Expects to maintain strong gross margins at or above 70% by continuing to drive ASP increases and reduce oncology COGS.

    What to watch in Q3 FY26

    5

    MolDX Medicare coverage for Northstar Response

    By end of year
    CurrentPublication of supporting clinical data
    TargetCoverage decision

    Why it matters

    This coverage is a significant catalyst, as Northstar Response accounts for almost two-thirds of oncology test volume.

    This publication is designed to support our pursuit of MolDX Medicare coverage for Northstar Response response in the IO and [ IO ] combination therapy settings. Since response accounts for almost 2/3 of our oncology test volume, this coverage remains one of our most meaningful catalysts and is still expected by the end of this year.

    Q&A highlights

    7

    Did prenatal test revenue increase sequentially when excluding true-ups, given the drop in true-up numbers?

    Yes, prenatal revenue, excluding true-ups, increased sequentially by about $4.5 million, representing approximately 5% growth. Both test volumes and ASPs for prenatal ex-true-up increased significantly.

    “I think quarter-to-quarter, we did see about a $4.5 million increase in prenatal revenues. If you exclude the true-up, it's about 5% growth sequentially.”

    asked by Mark Massaro · answered by Ross Taylor

    2 min read5 chapters

    Detailed Narrative

    01

    Revolutionary Technology Platform and Market Opportunity

    BillionToOne leverages its patented Quantitative Counting Template (QCT) technology, enabling single-molecule sensitivity with next-generation sequencing. This platform has allowed the company to rapidly scale to a $438 million annualized revenue run rate in six years, addressing an estimated $100 billion market in the United States for prenatal and oncology cell-free DNA testing. The technology underpins unique, category-defining products in both segments.

    02

    Strong Financial Performance and Fiscal Discipline

    The company achieved a 70.5% gross margin in Q2 FY26, an expansion of 5 percentage points year-over-year, despite a mix shift towards higher-COGS oncology tests. This superior margin, combined with a culture of fiscal discipline and AI-driven efficient operations, led to $5.5 million in GAAP operating income (5% operating margin) and a 15% adjusted EBITDA margin. The company's accumulated deficit is approximately 10% of its public competitors, demonstrating efficient capital use.

    03

    Prenatal Product Innovation and Adoption

    Unity Confirm, launched May 28, is the first noninvasive confirmation assay for high-risk pregnancies, capturing intact circulating fetal cells. It has seen exceptional early reception, with providers ordering it for over 50% of eligible high-risk patients. Additionally, the Unity fetal risk screen will expand to 130 genes on August 17, becoming the largest panel on the market and significantly increasing the serviceable market, especially for providers preferring large panels.

    04

    Oncology Product Development and Clinical Validation

    New clinical evidence was published on June 24, validating Northstar Response for monitoring immunotherapy, supporting pursuit of MolDX Medicare coverage expected by year-end. The company is also on track to launch a highly sensitive tumor-naive MRD test by year-end. Northstar Select will expand to 102 genes on September 1, and Northstar Origin, a tissue of origin add-on with 91% top 3 accuracy, will launch simultaneously, addressing a critical need in community oncology settings.

    05

    Commercial Expansion and EMR Integration

    BillionToOne added approximately 70 sales representatives in H1 FY26, ahead of plan, to drive future growth. The company launched on Epic's Aura platform in under five months, a record speed, and completed its first health system integration in just two weeks. While health system adoption will take time (2-4 quarters for full integration), Epic Aura removes a critical barrier. A new 62,000 sq ft oncology production lab is under construction, expected to support 5,000 tests per day by end of 2027.

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