Company: BLLN
Filing Date: 2025-06-20
Form Type: DRS
Source: 0000950123-25-006095
Chunk: 6

Company: BillionToOne, Inc.
Filing Date: 2025-06-20
Form: DRS
Chunk 6
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 type of testing becomes the standard of
care and significantly improves patient outcomes.

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-cancer liquid biopsy tests – Northstar Select and Northstar Response. Our Northstar Select test is used to guide therapy selection and has been shown to detect over 50% more actionable solid tumor
mutations than conventional liquid biopsies. Based 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.

2

Our business momentum is evidenced by our rapidly scaling commercial success and improving operational efficiency. To
date, we have processed more than one million smNGS-based tests, including tests in the 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. 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 of , representing year-over-year revenue growth. This translates to a net income improvement of approximately
, from a net loss of in the six months ended June 30, 2024 to a net income of in the same period in 2025.

Backed by our commitment to continued innovation and high-quality execution, we aim to lead the next wave of advancements in precision diagnostics, delivering profound
benefits to patients, providers, and the broader healthcare system.

Our four pillars of differentiation

AtBillionToOne, we are building a different type of molecular diagnostics company, backed by our four pillars of differentiation described below.