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BillionToOne — Third Quarter 2026 Earnings Summary

  • Financial Performance:

    • Total revenue reached $123.0 million in Q3 2026, a 47% increase year-over-year from $83.5 million in Q3 2025.
    • Prenatal clinical testing revenue was $104.3 million in Q3 2026, up 41% from $74.1 million in Q3 2025.
    • Oncology clinical testing revenue was $17.1 million in Q3 2026, a 96% increase from $8.7 million in Q3 2025.
    • Clinical trial support and other services revenue was $1.6 million in Q3 2026, up 115% from $0.8 million in Q3 2025.
    • Gross profit margin was 71% in Q3 2026, compared to 70% in Q3 2025.
    • Total tests delivered were 206,000 in Q3 2026, a 25% increase from 165,000 in Q3 2025.
    • Overall Average Selling Price (ASP) was $589 in Q3 2026, an 18% increase from $501 in Q3 2025.
    • Income from operations was $11.0 million in Q3 2026, compared to $9.6 million in Q3 2025.
    • Net income was $17.4 million ($0.32 per diluted share) in Q3 2026, compared to $1.5 million ($0.10 per diluted share) in Q3 2025.
    • Free cash flow was $8.6 million in Q3 2026.
    • Cash and cash equivalents were $561.5 million as of September 30, 2026, compared to $496.0 million as of December 31, 2025.
    • Long-term debt was $88.98 million as of September 30, 2026, compared to $57.23 million as of December 31, 2025.
    • Deferred revenue decreased to $1.91 million (current) and $28,000 (non-current) as of September 30, 2026, from $2.19 million (current) and $1.29 million (non-current) as of December 31, 2025.
  • Guidance and Future Outlook:

    • Full year 2026 revenue guidance was raised to a range of $460 million to $470 million, representing 51% to 54% growth over 2025.
    • Previous guidance for full year 2026 was $450 million to $465 million.
    • Management expects to continue generating profitability similar to current levels despite significant continued investments.
  • Business Segments and Product Lines:

    • Northstar Clear, a tissue-free MRD test for all solid tumors, is scheduled for commercial launch on December 15, 2026.
    • Northstar Response data published in The Journal of Liquid Biopsy showed 94% agreement with the most widely used tumor-informed assay in patients on active treatment for advanced cancer.
    • Unity Fetal Risk Screen data published in The Green Journal (Obstetrics & Gynecology) validated the product as a first-line prenatal screen with 94.4% sensitivity and 99.5% specificity.
    • Oncology products are growing faster than prenatal products, contributing to higher overall costs per test.
  • Market and Competitive Landscape:

    • Northstar Response demonstrated head-to-head performance against a tumor-informed assay in colorectal cancer.
    • Unity Fetal Risk Screen was validated in the largest prospective study of its kind in the intended-use population, conducted with nine U.S. institutions.
  • Risks and Challenges:

    • Forward-looking statements regarding revenue, income, and financial information are subject to risks and uncertainties, including factors beyond the company's control.
    • Actual results could differ materially from forward-looking statements due to various factors discussed in the company's Form 10-Q and Form 10-K filings.
    • Overall cost per test increased slightly in Q3 2026 due to the faster growth of higher-cost oncology products and a slight increase in prenatal cost per test.
  • Management Commentary and Tone:

    • Dr. Oguzhan Atay, Co-Founder and CEO, described the quarter as a period of "strong execution" with rapid growth and continued GAAP profitability.
    • Management noted that more clinicians are choosing tests in both prenatal and oncology segments.
    • The CEO expressed pride in the performance and stated the company is in the "early chapters" of what the platform can achieve.
  • Other Key Points:

    • The company announced the upcoming launch of Northstar Clear, a blood-only MRD test available for all solid tumors.
    • Net cash provided by operating activities for the nine months ended September 30, 2026, was $37.1 million.
    • Purchases of property and equipment for the nine months ended September 30, 2026, were $12.5 million.
    • Proceeds from the issuance of debt were $30.0 million for the nine months ended September 30, 2026.
    • Proceeds from the exercise of stock options were $12.2 million for the nine months ended September 30, 2026.
    • The company hosts a conference call on November 4, 2026, at 1:30pm Pacific Time.
Company
BILLIONTOONE INC
Sector
Healthcare
Industry
Diagnostics & Research