Company: BLLN
Filing Date: 2025-08-11
Form Type: DRS/A
Source: 0000950123-25-007483
Chunk: 132

Company: BillionToOne, Inc.
Filing Date: 2025-08-11
Form: DRS/A
Chunk 132
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 our unique fetal antigen tests resulted in national medical guideline changes, enabling us to position our tests as “the new standard in prenatal care,” further contributing to both test volume and ASP growth, as we leveraged the guideline changes to contract with more insurance companies. By detecting and identifying an extensive array of severe but actionable genetic disorders during pregnancy, we enable substantially better outcomes for newborns via earlier therapeutic and other clinical interventions. In the oncology setting, ultrasensitive tests with real-time insights are required to effectively detect, diagnose, and treat patients with a diverse range of mutations and solid tumor types across the cancer care continuum. In 2023, we successfully leveraged our smNGS platform to launch two complementary pan-cancerliquid biopsy tests – Northstar Select and Northstar Response. Our Northstar Select is used to guide therapy selection and has been shown to detect over 50% more actionable solid tumor mutations than conventional liquid biopsies. 18Based on our knowledge of all widely available tests, Northstar Response is the only methylation-based assay that quantifies the amount of cancer (tumor burden) at the single molecule level without requiring a tissue biopsy, enabling real-time monitoring of patient response to therapy with unprecedented precision. Our Northstar tests give physicians extraordinary visibility into cancer profile and treatment response, enabling more informed and earlier treatment decisions that can fundamentally alter patient outcomes.

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Our business momentum is evidenced by our rapidly scaling commercial success and improving operational
efficiency. Of approximately one million smNGS-based tests that we have processed since our initial launch, more than of them, tests, were processed within the last 12 months ended
June 30, 2025. For the year ended December 31, 2024, we generated revenue of $152.6 million, representing 113% year-over-year growth, with a gross margin of 53% and net loss of $41.6 million. While we have incurred losses since
inception, including a net loss of $41.6 million for the year ended December 31, 2024, and had an accumulated deficit of $282.2 million as of December 31, 2024, our business model has demonstrated improving operational leverage, which we
believe will enable us to reach, on a non-GAAP income from operations basis, positive operating income after adjusting for stock based compensation expense for the six months ended June 30, 2025.
During this period, we generated revenue of , with a gross margin of and a net income