0002070849-26-000017
SEC filingRevenue doubled to $305M, driven by 51% volume growth and 35% ASP increase, yielding first profitable year with $7.5M net income.
BillionToOne is a molecular diagnostics company built around its proprietary single-molecule next-generation sequencing (smNGS) platform. The company aims to redefine precision medicine by enabling ultrasensitive detection and quantification of cell-free DNA (cfDNA) targets, with applications in prenatal screening and oncology. Its smNGS platform uses patented Quantitative Counting Templates (QCTs) to achieve absolute quantification at the single-molecule level, overcoming limitations of traditional NGS methods.
The Business section describes two primary market areas: prenatal and oncology. However, no formal reporting segments with revenue allocation are disclosed. The prenatal segment includes the UNITY product portfolio, which comprises the UNITY Fetal Risk Screen, UNITY Aneuploidy Screen, UNITY Fetal RhD NIPT, and UNITY Fetal Antigen NIPT. The oncology segment includes Northstar Select (for therapy selection) and Northstar Response (for treatment monitoring), as well as add-on tests Northstar PGx and Northstar Select CH. A minimal amount of revenue (less than 1%) comes from international markets.
The foundational smNGS platform is powered by QCTs, custom bioinformatics, and specialized lab infrastructure. Key products include:
BillionToOne commercializes its tests in the United States through a direct sales force targeting physicians. As of December 31, 2025, the sales organization comprised 231 representatives (177 prenatal, 54 oncology). The prenatal sales force focuses on OB-GYNs, maternal-fetal medicine specialists, and genetic counselors. The oncology sales force primarily engages oncologists. International sales (less than 1% of revenue) are handled through distributors. The company relies on payor contracts covering approximately 250 million covered lives as of December 31, 2025. No specific customer concentration is disclosed.
In the prenatal market, competitors for NIPT include Illumina (Verinata), Labcorp, Myriad, Natera, and Quest. Carrier screening competitors include Fulgent, Labcorp, Myriad, Natera, and Quest. In oncology, competitors for therapy selection and response monitoring include Caris Life Sciences, Foundation Medicine (Roche), Guardant Health, NeoGenomics, and Tempus AI. For future MRD and early detection tests, the company expects competition from Exact Sciences, Grail, Haystack (Quest), and Natera. BillionToOne believes its four pillars of differentiation (breakthrough technology, category-defining products, rapid growth at scale, superior efficiency) provide competitive advantages.
The company's growth strategy includes: (1) driving increased adoption of existing prenatal and oncology products through sales force expansion and deeper penetration; (2) building clinical evidence to support coverage and reimbursement, including Medicare coverage for Northstar Response; (3) expanding the product portfolio using the smNGS platform, with a MRD test planned for 2026 and early-stage cancer detection as a longer-term goal; (4) deploying AI across operations to improve efficiency and reduce costs; and (5) leveraging the growing clinical dataset combined with AI to enable personalized medicine.
The Business section discloses sales force headcount: 231 sales representatives as of December 31, 2025 (177 prenatal, 54 oncology). The company also mentions medical science liaisons (genetic counselors in prenatal, PhDs in oncology) and other support staff. Total employee count is not provided.
For the year ended December 31, 2025, revenue increased 100% to $305.1 million from $152.6 million in 2024, driven by a 51% increase in delivered and billable test volume (to approximately 610,000 tests) and a 35% increase in overall ASP. Gross profit surged 158% to $208.5 million, with gross margin expanding 1,500 basis points to 68%, primarily due to ASP growth (accounting for 86% of margin improvement) and cost-per-test reductions (14%). Operating income swung to $16.0 million from a $(47.1) million loss, reflecting significant operating leverage as revenue growth outpaced expense growth. Net income was $7.5 million compared to a $(41.6) million loss in 2024, with the improvement aided by higher gross profit and controlled operating expense growth.
Prenatal tests represented 91% of revenue, oncology 8%, and other services 1%. In prenatal, volume growth was fueled by expansion of the sales force and increased market penetration, while ASP benefited from new payor contracts, a proprietary PLA code (reimbursed at higher rates), and higher attachment of 22q microdeletion and RhD tests. Oncology revenue grew from both Northstar Select and Northstar Response tests, supported by a dedicated oncology sales force and a pivotal Medicare coverage decision for Northstar Select in early 2025, which reduced denial rates. Overall, the revenue mix remained heavily weighted toward prenatal, but oncology is emerging as a growth driver.
Management expects to continue expanding its sales force across both prenatal and oncology segments, which should sustain test volume growth. ASPs are anticipated to benefit from additional payor contracts and coverage decisions, including potential MolDx coverage for Northstar Response. Cost-per-test reductions are expected through automation, lab optimization, and supplier negotiations, with fixed-cost leverage from increasing volumes. The company plans to occupy a new 220,000-square-foot laboratory in Austin, Texas in 2027, with commercial processing expected in 2028, tripling potential testing capacity. While no specific numerical guidance was provided, the company believes its current cash and equivalents ($496.0 million) are sufficient to fund operations for at least the next 12 months. Key risks include the ability to sustain ASP growth, manage payor reimbursement, and execute on expansion plans without disrupting operations.
As of December 31, 2025, BillionToOne held $495.975 million in cash and cash equivalents, a significant increase from $191.477 million at year-end 2024, driven primarily by the net proceeds of $286.9 million from the November 2025 IPO. Total assets stood at $632.654 million, up from $302.059 million. Working capital (current assets minus current liabilities) was approximately $512.596 million, indicating strong short-term liquidity. The company had no marketable securities beyond money market funds.
Total debt consisted of $57.226 million in long-term debt (a term loan with Oberland Capital measured at fair value) and $0.867 million in financing lease liabilities. The term loan has a mandatory third tranche of $30 million to be drawn before March 31, 2026, as revenue and gross margin thresholds were met. The company was in compliance with all financial covenants.
Operating lease commitments total $67.778 million, with $9.115 million due within one year. The company also has an off-balance-sheet lease for Austin, TX (expected to commence before September 2027) with an initial annual rent of $12.3 million and a 15.75-year term. No other material purchase commitments were disclosed. The company has a $30 million mandatory note issuance (third tranche) under the Oberland agreement, which will increase debt.
No share buyback program or dividends were declared or authorized. Capital expenditures totaled $8.881 million in 2025 (2.91% of revenue), primarily for lab equipment and leasehold improvements. Debt increased by $5.745 million, driven entirely by fair value adjustments on the term loan; no new debt was issued or repaid during the year. The company used IPO proceeds to strengthen its balance sheet rather than return capital to shareholders.
BillionToOne reports revenue across three segments: Prenatal ($277.105M, 90.8% of total), Oncology ($24.953M, 8.2%), and Clinical trial support & other ($3.054M, 1.0%). Prenatal revenue grew 90% YoY, while Oncology surged from $2.944M in 2024 due to commercial launch. Substantially all revenue is generated in the United States. Segment-level operating income is not disclosed, as the CODM reviews company-wide net income for resource allocation.
BillionToOne's revenue is heavily dependent on third-party payor reimbursement, representing over 90% of revenue. Any adverse changes in coverage or payment rates from Medicare, Medicaid, or commercial insurers—driven by PAMA implementation, coding changes, or policy shifts—could materially harm financial performance. The company also faces billing complexities and variable collection outcomes.
With a limited operating history (founded 2016, first commercial test in 2019), rapid growth strains management, infrastructure, and talent retention. The loss of co-founders or key scientific/technical staff could disrupt operations. Additionally, reliance on a single primary laboratory in Union City, CA, and planned expansion to Austin (2028) create geographic concentration risk.
As a provider of laboratory-developed tests (LDTs), the company faces potential FDA enforcement requiring premarket clearance, which would be costly and time-consuming. New legislation like the BIOSECURE Act may restrict use of foreign biotechnology equipment, impacting supply chain. The company is also subject to HIPAA and state privacy laws, with data breach risks.
The molecular diagnostics market is highly competitive, with entrenched players in prenatal (Natera, Myriad) and oncology (Foundation Medicine, Guardant). Rapid technological change could render products obsolete. Patent protection is uncertain; only 9 U.S. patents are held, and litigation is likely.
Despite achieving net income of $7.5M in 2025, the company had an accumulated deficit of $274.7M and may need additional capital. Material weaknesses in internal control over financial reporting were identified, posing risks to financial reporting reliability and investor confidence.