BillionToOne Reports Third Quarter 2026 Results and Raises 2026 Revenue Guidance

MENLO PARK, Calif., Nov. 04, 2026 (GLOBE NEWSWIRE) -- BillionToOne, Inc. (NASDAQ: BLLN), a next-generation molecular diagnostics company with a mission to create powerful and accurate tests that are accessible to all, today reported its financial results for the third quarter ended September 30, 2026 and raised guidance for full year 2026.

• Total revenue of $123.0 million in the third quarter of 2026, compared to $83.5 million in the third quarter of 2025, an increase of 47%.

• Prenatal clinical testing revenue was $104.3 million in the third quarter of 2026, an increase of 41% from the third quarter of 2025.

• Oncology clinical testing revenue was $17.1 million in the third quarter of 2026, 96% higher than the $8.7 million reported in the third quarter of 2025.

• Gross profit margin was 71% in the third quarter of 2026, compared to 70% in the third quarter of 2025, a one percentage-point increase year-over-year.

• 206,000 tests delivered in the third quarter of 2026, compared to 165,000 tests delivered in the third quarter of 2025, an increase of 25%.

• Income from operations of $11.0 million in the third quarter of 2026, compared to income from operations of $9.6 million in the third quarter of 2025.

• Free cash flow, defined as cash flow from operations minus capital expenditures, was $8.6 million in the third quarter of 2026.

• Raising 2026 full year revenue guidance to be in a range of $460 million to $470 million, which represents 51% to 54% growth over 2025.

• Expects to operate the business such that it will continue to generate profitability similar to current levels, even with significant continued investments.

• Today, we announced the upcoming launch of Northstar Clear, a tissue-free MRD test for patients with all solid tumors, which will be commercially available on December 15, 2026. Its pan-cancer, blood-only design makes it available on day one for all solid tumors, and initial data in colorectal cancer will show head-to-head performance against a tumor-informed assay.

• In October 2026, we announced peer-reviewed data published in The Journal of Liquid Biopsy from the first head-to-head comparison of Northstar Response with the most widely used tumor-informed assay in patients on active treatment for advanced cancer. The two assays agreed on the direction of ctDNA change in 94% of sequential pairs (67 of 71), and in all four divergent cases clinical records supported Northstar Response’s findings.

• In August 2026, we announced peer-reviewed data published in The Green Journal (Obstetrics & Gynecology) validating Unity Fetal Risk Screen as a first-line prenatal screen. The study is the first and largest prospective study of Unity Fetal Risk Screen in its intended-use population and was conducted in collaboration with nine U.S. institutions, demonstrating 94.4% sensitivity and 99.5% specificity.

“Our third quarter was another period of strong execution,” said Dr. Oguzhan Atay, Co-Founder and CEO of BillionToOne. “We delivered rapid growth with continued GAAP profitability, and more clinicians are choosing our tests in both prenatal and oncology. This quarter we also strengthened the clinical evidence behind our platform. Published data validated Unity Fetal Risk Screen as a first-line prenatal screen, and Northstar Response delivered strong results in the first head-to-head study of its kind. I am also pleased to announce that next month, we plan to launch Northstar Clear, our MRD test. Overall, we are proud of our performance so far in 2026 and believe we are still in the early chapters of what our platform can achieve.”

Total revenue was $123.0 million in the third quarter of 2026 compared to $83.5 million in the third quarter of 2025, an increase of 47%. The increase in total revenue was driven by a 25% increase in the number of total tests delivered and an 18% increase in Overall ASP. Both prenatal and oncology delivered strong test volume growth year-over-year.

Gross profit was $87.1 million in the third quarter of 2026, compared to $58.4 million in the third quarter of 2025, representing a gross margin of 71% in the third quarter of 2026 and 70% in the third quarter of 2025. An increase in Overall ASP drove the improvement in gross profit margin compared to the third quarter of 2025. Overall cost-per-test increased slightly in the third quarter of 2026 compared to last year. The increase was driven by the faster growth of our oncology products, which have higher costs per test, and a slight increase in our prenatal cost per test, partially offset by improvements in cost-per-test for both of our oncology products.

Total operating expenses were $76.1 million in the third quarter of 2026, compared to $48.8 million in the third quarter of 2025, an increase of 56%.

Income from operations was $11.0 million in the third quarter of 2026, compared to income from operations of $9.6 million in the third quarter of 2025. Operating margin was 9% in the third quarter of 2026.

Net income in the third quarter of 2026 was $17.4 million, or $0.32 per diluted share, compared to net income of $1.5 million, or $0.10 per diluted share, in the third quarter of 2025.

BillionToOne now expects full year 2026 total revenue of $460.0 million to $470.0 million, representing growth of 51% to 54% compared to full year 2025. This compares to the company's previous guidance of $450.0 million to $465.0 million.

BillionToOne also expects to operate the business such that it will continue to generate profitability similar to current levels, even with significant continued investments.

BillionToOne will host a conference call today, November 4, 2026, at 1:30pm Pacific Time / 4:30pm Eastern Time. Investors interested in listening to the conference call are required to register online. A live and archived webcast of the event for interested listeners can be accessed at https://investors.billiontoone.com/.

Headquartered in Menlo Park, California, BillionToOne is a molecular diagnostics company with a mission to create powerful and accurate tests that are accessible to all. The company's patented Quantitative Counting Templates™ (QCT™) molecular counting platform is the only multiplex technology that can accurately count DNA molecules at the single-molecule level.

This press release contains certain forward-looking statements within the meaning of federal securities laws. These forward-looking statements generally are identified by the words “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “strategy,” “future,” “opportunity,” “plan,” “may,” “should,” “will,” “would,” “will be,” “will continue,” “will likely result,” and similar expressions. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Forward-looking statements in this press release include, but are not limited to, statements regarding revenue, income and other financial information for the full year of 2026. These statements are based on management’s current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors, some of which are beyond BillionToOne’s control. These and additional risks and uncertainties that could affect BillionToOne’s financial and operating results and cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. These risks and uncertainties include those discussed under the captions “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in BillionToOne’s most recently filed quarterly report on Form 10-Q, the annual report on Form 10-K and other filings BillionToOne makes with the Securities and Exchange Commission from time to time. The forward-looking statements in this press release are based on information available to BillionToOne as of the date hereof, and BillionToOne disclaims any obligation to update any forward-looking statements provided to reflect any change in its expectations or any change in events, conditions, or circumstances on which any such statement is based, except as required by law. These forward-looking statements should not be relied upon as representing BillionToOne’s views as of any date subsequent to the date of this press release.

We use certain non-GAAP financial measures to supplement our unaudited financial results, which are presented in accordance with GAAP. These non-GAAP financial measures include EBITDA, adjusted EBITDA and free cash flow. By excluding the impact of certain items that we believe do not directly reflect our underlying operations, we are of the opinion that EBITDA, adjusted EBITDA and free cash flow provide meaningful supplemental information regarding our performance. Accordingly, we believe these non-GAAP financial measures are useful to investors and others because they allow for additional information with respect to financial measures used by management in its financial and operational decision-making and forecasting. These metrics also provide investors and other users of our financial information with additional tools to compare business performance across companies and periods, while eliminating the effects of items that may vary for different companies for reasons unrelated to core operating performance. However, there are a number of limitations related to the use of non-GAAP financial measures, and these non-GAAP measures should be considered in addition to, not as a substitute for or in isolation from, our financial results prepared in accordance with GAAP. Other companies, including companies in our industry, may calculate these non-GAAP financial measures differently or not at all, which reduces their usefulness as comparative measures. A reconciliation between GAAP and non-GAAP financial information is provided immediately following the financial tables. A reconciliation of the forecasted range for adjusted EBITDA for the full year 2026 is not included in this release due to the number of variables in the projected range and because we are currently unable to quantify accurately certain amounts that would be required to be included in the U.S. GAAP measure or the individual adjustments for such reconciliation.

We define EBITDA as net income (loss) adjusted for income taxes, interest income, interest expense, and depreciation and amortization expense.

We define Adjusted EBITDA as net income (loss) adjusted for income taxes, interest income, interest expense, depreciation and amortization expense, and certain other items which include significant non-cash items and events that are highly variable, significant in size, and that we do not believe are indicative of ongoing or future business operations, which include: stock-based compensation expense; change in fair value of term loan; and change in fair value of warrant liabilities.

We define Free Cash Flow as net cash provided by operating activities adjusted for purchases of property and equipment.