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BillionToOne (BLLN) Q4 FY25 earnings call: guidance and Q&A

Earnings call· Dec 2025 (Q4 FY25)· Health Care· Mar 4, 2026

Source: earnings call transcript

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

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

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)—

BLLN operating KPIs by quarter

BLLN operating KPIs stated on its earnings calls, by fiscal quarter
KPIThis call Dec 2025 Q4 FY25 Mar 2026 Q1 FY26 Jun 2026 Q2 FY26Change vs prior quarter
Procedures
~170K Our leadership in product innovation and our growing commercial team continue to drive our test volume with Q4 reaching approximately 170,000 tests, a 47% year-over-year increase. Source: earnings call transcript
~188K In Q1, we delivered approximately 188,000 tests, representing 44% year-over-year growth and strong sequential growth across both product lines, with prenatal volumes growing approximately 10% quarter-over-quarter and oncology volumes growing approximately 25% quarter-over-quarter. Source: earnings call transcript
——
Average selling price
$561 Overall ASP increased another 12% quarter-over-quarter from $501 to $561, a significant $60 per test increase in a single quarter. Source: earnings call transcript
$571 As our ASPs increased 28% year-over-year to $571 per test and as we maintained our COGS at $153 per test despite the higher proportion of oncology tests that have a higher COGS, we expanded our gross margins to 73% in Q1, a strong 9 percentage point increase year-over-year. Source: earnings call transcript
$551 Overall ASP increased 21% year-over-year to $551 per test. Source: earnings call transcript
-3.5%

Operating figures the company stated on at least two of the calls shown, checked against each call's transcript. Click a figure to read the sentence. A dash means it was not stated that quarter.

Product announcements

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

UnitedHealthcare In-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

Mix shift to oncology limiting margin expansion Near-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 adoption Likely 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 monitoring Current

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

Health system adoptions

H2 FY26
Current Clinical buy-in, EMR integration pending
Target 1-3 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.

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Q&A highlights

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 read 5 chapters

Detailed narrative

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.

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.

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.

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.

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.

Summary of the company's earnings call; see how call summaries are prepared. Not investment advice.