Billiontoone Q1 Earnings Call Highlights

Key Points

• BillionToOne reported Q1 revenue of $108.4 million, up 84% year‑over‑year, delivered GAAP profitability with operating income of $17.8M and net income of $18.0M, and expanded gross margin to 73%.
• Test volumes grew 44% to about 188,000 tests while average selling price rose 28% to $571 per test, and management expects to sustain gross margins of 70%+ despite oncology mix and quarterly volatility.
• Commercial and product catalysts include becoming in‑network with Anthem (bringing contracted lives to ~300 million), launching the non‑invasive prenatal follow‑up UNITY Confirm, and raising 2026 revenue guidance to $450–$465 million.

Billiontoone NASDAQ: BLLN reported first-quarter 2026 results showing rapid revenue growth alongside GAAP profitability, driven by higher test volumes, rising average selling prices (ASPs), and expanding gross margins. Management also highlighted the launch of a new prenatal confirmation offering, additional payer contracting progress, and ongoing product development milestones in oncology.

Quarterly results: revenue up 84% with positive operating income

Chief Financial Officer Ross Taylor said total revenue in the first quarter ended March 31, 2026 rose 84% year over year to $108.4 million, compared with $59.0 million in the prior-year period. He attributed the increase to growth in test volumes across both prenatal and oncology lines, as well as continued expansion in ASPs.

Prenatal revenue increased 72% year over year to $97.7 million, while oncology revenue increased almost 400% to $10.7 million. CEO Ozan Atay characterized the oncology performance as “nearly 5x over last year,” and said it represented an annualized run rate of about $43 million.

Taylor noted “true-up revenue” of $9.2 million in the quarter, compared with $8.4 million in the fourth quarter of 2025 and $2.9 million in the first quarter of 2025. Excluding true-up revenue, he said total revenue growth was 77% year over year.

Gross profit was $79.1 million, up from $38.0 million a year earlier, and gross margin expanded to 73% from 64%. Taylor said the gross margin improvement was “primarily attributable to continued increases in our overall ASP.”

Operating expenses rose 52% year over year to $61.2 million, with R&D expense of $14.7 million and SG&A expense of $46.6 million. Despite higher spending, Taylor said operating expenses as a percentage of revenue declined materially. Operating income was $17.8 million versus an operating loss of $2.3 million a year ago, producing a 16% operating margin. Net income available to common shareholders was $18.0 million, or $0.34 per diluted share, compared with a net loss of $4.0 million, or $0.39 per diluted share, in the prior-year quarter.

Cash flow from operations minus capital expenditures was $11 million, and the company ended the quarter with $537 million in cash and equivalents.

Test volumes grew 44% as ASPs rose to $571 per test

Atay said the company delivered approximately 188,000 tests in the quarter, representing 44% year-over-year growth. Prenatal volumes increased about 10% sequentially, while oncology volumes increased about 25% sequentially.

Overall ASP increased to $571 per test, up 28% year over year and $10 per test sequentially. Atay said the increase came despite “the largely temporary effect of resetting of coinsurance and deductibles at the beginning of the year.” He added that management sees room for continued ASP expansion, citing additional Medicaid adoption of the company’s carrier panel PLA code, mix shift toward oncology, and potential future Medicare coverage for Northstar Response.

Cost of goods sold (COGS) per test was $153, down 5% sequentially and up 1% year over year, which Atay described as notable given a higher mix of oncology tests and the impact of recent launches and enhancements such as CH. Gross margin expanded to 73% in the quarter, up 9 percentage points year over year and 2 points sequentially.

In Q&A, Taylor said the company expects to sustain “70% or better” gross margin over the course of the year, while noting quarterly volatility. Atay said oncology margins remain lower without Medicare coverage for Response, and that rapid oncology growth can limit near-term margin expansion, though he said the company still expects margins to remain above 70%.

Anthem agreement expands contracted lives to about 300 million

Atay said the company is now in-network with Anthem, which he called a “major step forward.” He said the Anthem agreement brings total contracted lives to approximately 300 million in the U.S., representing “more than 90% of patients.”

In response to analyst questions, Atay confirmed UnitedHealthcare’s effective date was April 1, and said Anthem “is already effective.” He also said the company is signing “roughly five to 10 contracts almost every month now,” and that the contracts are incrementally supporting ASPs.

Taylor addressed accounts receivable, saying the company entered into a number of contracts during the quarter, including some late in Q1, and reimbursement may not arrive for several months. He said new contracting drove about half of the increase in accounts receivable, and he expects it to decline by the end of Q2 or “certainly by the end of Q3,” depending on timing.

UNITY Confirm launched as non-invasive follow-up for high-risk NIPT results

Atay highlighted a new prenatal product launch announced May 1 at the ACOG Annual Meeting: UNITY Confirm. He described it as “the first and only non-invasive confirmation assay for high-risk pregnancies,” designed as a follow-up for high-risk results identified on the company’s UNITY Aneuploidy Screen.

According to Atay, UNITY Confirm captures and sequences intact circulating fetal cells from a maternal blood sample, providing “100% fetal fraction,” in contrast to conventional cell-free DNA tests that rely on smaller fetal DNA fractions in maternal plasma. He said the current standard next step after a high-risk NIPT is invasive diagnostic testing, which can be inaccessible in some settings and carries a small miscarriage risk, and that many patients do not proceed with invasive confirmation.

Atay said initial results have shown “100% concordance compared to invasive diagnostics,” and that the company is enrolling patients in what he described as the largest prospective circulating fetal cell-based study ever conducted with concordance to invasive diagnostics. He said more than 500 providers attended the launch or watched via livestream.

On commercialization, Atay told analysts that he expects the direct reimbursement or revenue contribution from UNITY Confirm to be “quite minimal, if any,” because he expects it to apply to roughly 0.5% to 1% of patients who test positive on a cell-free DNA test. Instead, he emphasized that patients are only eligible for UNITY Confirm if they used UNITY Aneuploidy, which he believes will increase interest in the company’s frontline aneuploidy screening.

Regarding the clinical study, Atay said enrollment and readout could take “anywhere between one to three years,” citing reduced rates of invasive testing over time. He added that the trial includes both CVS and amniocentesis, with the primary endpoint focused on CVS.

Oncology roadmap: MRD launch targeted by year-end; Response coverage work continues

In oncology, Atay said the product roadmap remains on track and that the company has responded to all MolDX comments for its submission related to coverage for Northstar Response. He said the tumor-naive MRD launch is on track for the end of the year.

During Q&A, Atay said the company plans to launch MRD “with data at the time of the launch,” potentially via a manuscript rather than at a specific conference.

He also provided color on ordering patterns, saying the Response-to-Select ratio is holding steady at about 2:1, driven by varied physician practices. He said the blended ratio “really speaks to the value of a Medicare coverage of a response test for us.”

Asked about MolDX timelines, Atay said the company is not seeing issues and that MolDX is responding within stated timelines of 60 days. He said the process has been productive and that management does not anticipate delays, adding it “might even potentially be slightly earlier than we originally anticipated.”

2026 guidance raised

Taylor said the company raised its full-year 2026 revenue outlook to $450 million to $465 million, representing 48% to 52% growth compared with full-year 2025. The new range is $20 million higher at both ends than the prior $430 million to $445 million guidance provided in early March.

He said the increase reflects the strength of Q1 results and expectations that new payer contracts will benefit ASPs through the remainder of the year. In Q&A, Taylor clarified the guidance raise is “primarily driven by lift in ASPs” and Q1 performance, with no assumed increase in volume beyond the Q1 outperformance. He also noted Q4 is typically seasonally slower due to holidays, while he expects some sequential growth in Q2 and Q3.

Taylor added that the company does not include true-up revenue in guidance beyond the “historical” Q1 numbers already realized.

About Billiontoone NASDAQ: BLLN

BillionToOne NASDAQ: BLLN is a molecular diagnostics company that develops and commercializes high-precision genetic testing solutions based on single-molecule counting technology. The company’s platform is designed to detect and quantify rare genetic variants and chromosomal abnormalities from cell-free DNA, with a primary focus on applications in prenatal screening and other clinical genetic tests where sensitivity and specificity at very low allele fractions are critical.

BillionToOne’s offerings center on assay development and clinical testing workflows that enable non-invasive prenatal testing (NIPT) and targeted molecular diagnostics.

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