BLLN 10-K & 10-Q changes, risk factors and insider trading

The following discussion and analysis of our financial condition and results of operations should be read together with our unaudited financial statements and the related notes included in Part 1, Item 1 of this Quarterly Report. The following discussion and analysis as well as other parts of this Quarterly Report contains forward-looking statements that involve risks, uncertainties and assumptions including information with respect to our plans and strategy for our business. Our actual results and timing of selected events could differ materially from those anticipated in these forward-looking statements as a result of many factors, including, but not limited to, those discussed under Part I, Item 1A “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2025. See also the section titled “Special Note Regarding Forward-Looking Statements” in this Quarterly Report. Unless context requires otherwise, references to “we,” “us,” “our,” “BillionToOne,” or “the Company” here refer to BillionToOne, Inc.

Founded with the mission to remove the fear of the unknown through powerful and accessible smNGS-based diagnostics, we have swiftly transitioned from an R&D-focused company to a proven commercial organization. Since launching UNITY, our first prenatal product in 2019, we have expanded our offerings first within prenatal genetics, and then to oncology diagnostics. To date, we have processed more than one and a half million smNGS-based tests. Today, we test approximatelymore than 1 in 1110 babies during pregnancy in the United States, a metric that is continuing to increase rapidly every year. UNITY is the first single-gene non-invasive prenatal test (sgNIPT) that uses cfDNA to provide fetal risk assessment for recessive conditions such as sickle cell disease (SCD) and cystic fibrosis (CF) without requiring a paternal sample or invasive procedures such as amniocentesis. Since then, we have expanded our UNITY offering to cover comprehensive prenatal genetic needs from a single maternal blood draw. In 2024, 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 average selling price (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 May 2026, we announced the launch of Unity ConfirmTM, a circulating fetal cell-based, non-invasive confirmation assay designed to enable confirmation of high-risk screening results. The new assay isolates intact circulating fetal cells from a simple maternal blood draw using BillionToOne’s Fetal Cell CaptureTM technology. With the assay, clinicians can confirm a high-risk result from a maternal blood draw without putting the pregnancy at risk from invasive methods such as chorionic villus sampling (CVS) or amniocentesis. In August 2026, we announced the upcoming expansion of the Unity Fetal Risk Screen with the addition of a 130-gene panel, which is currently the largest single-gene NIPT panel available.

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. We are actively developing additional diagnostic products to address critical needs across the cancer care continuum. For example, in January 2026, we launched Northstar PGx, andPGxTM, in February 2026, we launched Northstar Select CH.CHTM, and in August 2026 we announced the launch of Northstar OriginTM. Northstar PGx and Northstar Select CH are add-on applications for Northstar Select, and expand the Northstar platform beyond genomic profiling to address chemotherapy safety (PGx) and clonal hematopoiesis (CH) — two critical decision points in selecting the right therapy for patients. Northstar Origin is an add-on tissue-of-origin feature for our Northstar Select test that can benefit patients with unknown or uncertain diagnoses. Our current development efforts focus on MRD detection, leveraging our platform’s exceptional sensitivity to identify trace amounts of tumor DNA following curative-intent surgery in earlier stage cancers. We are developing a tissue-free, pan-cancer MRD test, which we expect to be commercially available in the fourth quarter of 2026.

Our business momentum is evidenced by our rapidly scaling commercial success and improving operational efficiency. Of the over one and a half million smNGS-based tests that we have processed since our initial launch, over 45%42% of them, or approximately 676,000726,000 tests, were processed within the last 12 months ended MarchJune 31,30, 2026.

Our total test volume, which represents the number of billable tests that we receive for processing during each period and which we also refer to as tests accessioned, grew to approximately 189,000197,000 tests for the three months ended MarchJune 31,30, 2026, compared to 137,000148,000 for the three months ended MarchJune 31,30, 2025. In addition, our total delivered and billable test volume, which represents the number of billable tests for which we deliver a result to the ordering provider each period, grew to approximately 188,000196,000 tests for the three months ended MarchJune 31,30, 2026, compared to 131,000145,000 delivered and billable tests for the three months ended MarchJune 31,30, 2025.

We believe certain factors have influenced, and will continue to influence, our operating performance and results of operations. While each of these factors presents significant opportunities for our business, they also pose important risks and challenges that we must successfully address to sustain and grow our business and improve our results of operations. Our ability to successfully address the factors below is subject to various risks and uncertainties, including those described under Part I, Item 1A. “Risk Factors.Factors” in our Annual Report on Form 10-K for the year ended December 31, 2025.

Our ASPs and revenue depend heavily on our success in achieving and maintaining broad coverage and adequate reimbursement for our molecular diagnostic tests from third-party payors. Third-party reimbursement for our tests represented more than 90% of our revenue for the threesix months ended MarchJune 31,30, 2026, and we expect government and commercial third-party payors to continue to be our primary source of payments. Coverage and reimbursement by third-party payors, including commercial health insurers, managed care organizations, and government healthcare programs such as Medicare and Medicaid, can be limited and uncertain for the types of specialized molecular diagnostic tests we offer. Each payor makes its own determination as to whether to establish a policy to cover our tests, as well as the amount it will reimburse for such tests. Payors make these determinations based on factors that include medical necessity, clinical utility, and cost-effectiveness. Reimbursement rates vary significantly by test-type, payor, and coverage determination. Historically, our market access and reimbursement teams have pursued strategies to increase our ASPs by expanding our payor coverage and reimbursement. We believe these strategies will continue to grow our ASPs over time.

We actively seek ways to continuously reduce our costs-per-test and improve our gross profit margin, long-term profitability, and return on investment. For example, we have reduced COGS per test through automation and optimization of laboratory workflows, successful negotiations with suppliers, and re-design and re-validation of assays with more optimized chemistry or higher-throughput sequencing. Nevertheless, as our test volumes grow, we have made and will continue to make significant investments in state-of-the-art infrastructure to support our growth. In 2023 we successfully expanded our laboratory operations from a single facility with 36,000 square feet in Menlo Park, CACalifornia by adding a second laboratory facility in Union City, CACalifornia with 90,000 square feet. To further support our growth beyond our current facilities, we have also entered a lease for the construction of 220,000 square feet of laboratory space in Austin, Texas withwhich favorable terms andincludes a tenant improvement package. We expect to occupy this facility in 2027, and open for processing commercial samples in 2028. Once the facility is fully utilized, we expect our potential testing capacity to be nearly triple our current capabilities.capabilities In addition, in June 2026, we entered a lease for a third laboratory facility in Union City, California with approximately 62,659 square feet of office and laboratory space, which includes a tenant improvement package. This facility, which we expect to occupy in 2027, will be dedicated to our oncology products and more than triple the current oncology-dedicated laboratory space.

The majority of our revenue is derived from sales of our prenatal test, UNITY, and a smaller portion is derived from sales of our liquid biopsy oncology tests, Northstar. Specifically, during the year ended December 31, 2025, 91% of our revenue was from our prenatal tests, 8% of our revenue was from our oncology tests, and 1% of our revenue was from our clinical trial support and other services. Additionally, during the threesix months ended MarchJune 31,30, 2026 and 2025, approximately 89%88% and 95%,93%, respectively, of our revenue was from our prenatal tests, 10%11% and 4%,6%, respectively, of our revenue was from our oncology tests, and 1% and 1%, respectively, of our revenue was from our clinical trial support and other services. We market our products to health clinics and physicians or a combination of the insurance carrier and patient for fees. Revenue for tests is recognized when test results are delivered to the ordering physician.

Other expense,income (expense), net is comprised of the change in fair value of our liabilities related to warrants for common stock and redeemable convertible preferred stock and various income or expense items of a non-recurring nature.

We account for uncertain tax positions in accordance with ASC 740-10, Accounting for Uncertainty in Income Taxes. We recognize the tax effects of an uncertain tax position only if it is more likely than not to be sustained based solely on its technical merits as of the reporting date and only in an amount more likely than not to be sustained upon review by the tax authorities. Interest and penalties related to uncertain tax position are classified in the unaudited financial statements as income tax expense.

Comparison of the three months ended MarchJune 31,30, 2026 and 2025

The following table sets forth information derived from our statements of operations and comprehensive income (loss) for each of the periods presented:

NM = Not meaningful (1) Includes stock-based compensation expense as follows:

Revenue increased $49.4$42.9 million, or 84%,64%, for the three months ended MarchJune 31,30, 2026 compared to the three months ended MarchJune 31,30, 2025. This increase was driven primarily by a 44%35% increase in the total volume of delivered and billable tests to approximately 188,000196,000 for the three months ended MarchJune 31,30, 2026 from approximately 131,000145,000 for the three months ended MarchJune 31,30, 2025. The increase in revenue was also attributable to an increase in our Overall ASP of 28%.21%. Overall ASP is the weighted average ASP across all of our prenatal and oncology products. It is computed by dividing revenue for our prenatal and oncology tests by the number of tests that are delivered and billable. The number of tests that are delivered and billable in a given period represents the number of billable tests for which we deliver a result to the ordering provider in such period. Furthermore, new agreements with payors entered into in the first quarter of 2026 resulted in an increase in revenue related to expected payments on the reprocessing of claims for tests delivered in the three months ended March 31, 2026 and the year ended December 31, 2025. Revenue related to services performed during the year ended December 31, 2025 that were covered by these payors contributed slightly more than half of the $9.2 million in revenue related to performance obligations satisfied in prior periods for the three months ended March 31, 2026.

The increase in test volume was driven by higher volumes of our prenatal tests primarily as a result of the expansion of our sales force for our prenatal products. In addition, volumes for both our Northstar Select and Northstar Response oncology tests increased as a result of the expansion of our oncology sales force. The increase in our ASP per test was driven by several factors. For example, we increased the number of contracts compared to last year that we have with payors for our prenatal tests and we continued to benefit from our proprietary PLA code, both of which drove increases in ASP for the three months ended MarchJune 31,30, 2026 compared to the same period in the prior year.

Cost of revenue increased $8.3$9.2 million, or 40%, for the three months ended MarchJune 31,30, 2026 compared to the three months ended MarchJune 31,30, 2025. The increase was primarily due to an increase of $5.7$4.9 million in expenses associated with testing samples and supplies used in processing tests, phlebotomy, and related shipping costs, driven by a higher volume of tests processed; and an increase of $2.6$4.3 million in labor and consulting related expenses, including stock-based compensation, which were driven by higher test volumes and an increase in product support.

Gross profit increased $41.1$33.6 million, or 108%,77%, for the three months ended MarchJune 31,30, 2026 compared to the three months ended MarchJune 31,30, 2025. The increase was primarily due to an increase in the number of tests processed and a higher Overall ASP inslightly conjunctionoffset withby a lowersmall increase in Overall Cost Per Test as wethe continuedsales mix shifted towards the faster growing oncology products which have a higher cost-per-test than prenatal. Some of the increase from the shift in sales mix was offset by our programs to actively reduce variable expenses and increase efficiency from our fixed costs. Overall Cost Per Test is the weighted average cost per test across all of our prenatal and oncology products. It is computed by dividing cost of goods sold for our prenatal and oncology tests by the number of tests that are accessioned. The number of tests that are accessioned in a given period represents the number of billable tests that we receive for processing during such period. We refer to this number as our “Total Test Volume.”

Gross margin increased to 73%70% for the three months ended MarchJune 31,30, 2026 from 64%65% for the three months ended MarchJune 31,30, 2025 for the reasons described above.

The increase in our Overall ASP contributed to all of the improvement of our gross profit margin for the three months ended MarchJune 31,30, 2026 as compared to the three months ended MarchJune 31,30, 2025. This improvement was partially offset by an increase in our Overall Cost Per Test byof 1%3% for the three months ended MarchJune 31,30, 2026 as compared to the three months ended MarchJune 31,30, 2025, offsetting some of the benefit on gross margin from the increase in Overall ASP over the same periods.2025. Cost Per Test for both of our oncology products and for our prenatal products declined during the 3three months ended MarchJune 31,30, 2026 compared to both the three months ended DecemberMarch 31, 20252026 and the three months ended MarchJune 31,30, 2025. However, these improvements were offset by a shift in the sales mix towards oncology products which have higher costs-per-test, resulting in the 1% increase in our Overall Cost Per Test.

Research and development expenses increased $4.3$5.6 million, or 41%,47%, for the three months ended MarchJune 31,30, 2026 compared to the three months ended MarchJune 31,30, 2025. The increase was primarily due to a $2.2$2.7 million increase in personnel costs which included $0.6$0.9 million in stock-based compensation expense, a $1.6$1.5 million increase in materials,reagents and supplies costs, a $0.6 million increase in equipment expenses and overhead allocations, a $0.3$0.6 million increase in clinical studies expense and a $0.2 million increase in consulting and other costs and a $0.2 million increase in clinical studies expense.costs. The increase in research and development expenses was primarily driven by an increase in our average research and development headcount of 3028 employees during the periods presented to support our product development and innovation efforts.

Selling, general and administrative expenses increased $16.7$20.9 million, or 56%,63%, for the three months ended MarchJune 31,30, 2026 compared to the three months ended MarchJune 31,30, 2025. The increase was primarily due to ana $12.3$16.9 million increase in salaries, commissions and related expenditure which included $3.3$4.2 million in stock-based compensation expense, a $2.5$1.6 million increase in professional and consulting fees, a $1.0 million increase in facilities and other costs, and a $1.9$0.9 million increase in professionalallocated IT and consultingsoftware licenses expense and a $0.5 million increase in reimbursement collection services fees. The increase in selling, general and administrative expenses was driven by an increase in our average selling, general and administrative headcount of 129139 employees during the periods presented to support our sales, marketing and other corporate strategies.

Interest income increased by $3.1$3.2 million, or 208%,224%, for the three months ended MarchJune 31,30, 2026 compared to the three months ended MarchJune 31,30, 2025. The increase was primarily due to a higher average balance of cash and cash equivalents, compared to the three months ended MarchJune 31,30, 2025, due to the proceeds from our IPO in November 2025.

Interest expense decreased $30.0$24.0 thousand, or 75%, for the three months ended MarchJune 31,30, 2026 compared to the three months ended MarchJune 31,30, 2025.

Change in fair value of term loan increased $1.2$3.0 million, or 38%million for the three months ended MarchJune 31,30, 2026 compared to the three months ended MarchJune 31,30, 2025. The increase was due to a change in fair value of the Oberland Capital debt of $1.0$2.2 million, primarily related to the draw of the third tranche on March 31, 2026, an increase in interest expense of $0.6 million and an increase in revenue participation payments of $0.2$0.1 million.

Other expense,income (expense), net increased $0.2$0.3 million, or 468%,million for the three months ended MarchJune 31,30, 2026 compared to the three months ended MarchJune 31,30, 2025. The increase was primarily due to $0.6 million in other income related to an insurance recovery offset by a $0.3 million decrease in the fair value of our Class A common stock warrants, due to athe reductionexercise in expected term, which was partially offset by losses incurred onof the disposalClass ofA fixedcommon assets.stock warrants during the three months ended June 30, 2026.

We use certain non-GAAP financial measures to supplement our unaudited financial statements, which are presented in accordance with GAAP. These non-GAAP financial measures include EBITDA, Adjusted EBITDA, non-GAAP income (loss) from operations, and non-GAAP net income (loss). We use these non-GAAP financial measures for financial and operational decision-making and as a means to assist us in evaluating period-to-period comparisons. 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, non-GAAP income (loss) from operations and non-GAAP net income (loss) 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- GAAPnon-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.

We monitor non-GAAP net income (loss) for planning and performance measurement purposes. We define non-GAAP net income (loss) as net income (loss) reported on our statements of operations,operations and comprehensive income (loss), excluding the impact of stock-based compensation expense, change in fair value of the term loan,loan and change in fair value of convertiblewarrant notes.liabilities. We exclude fair value adjustments related to debt, which can fluctuate significantly and do not directly reflect our underlying operations. Our calculation of non-GAAP net income (loss) does not currently include the tax effects of the stock-based compensation expense adjustment because such tax effects have not been material to date.

Since our inception, prior to our IPO, we financed our operations primarily through the issuance of convertible notes, redeemable convertible preferred stock, debt, and cash generated from the sale of our products. As of MarchJune 31,30, 2026, our principal sources of liquidity were cash and cash equivalents of $537.5$548.6 million and working capital of $567.0$595.7 million. On November 7, 2025, we closed our IPO of our Class A common stock. The total net proceeds received were approximately $286.9 million after deducting underwriting discounts, commissions and offering expenses payable by us. Cash and cash equivalents are comprised of cash held in sweep accounts, checking accounts, lock-box accounts and money market funds. Our principal use of cash is to fund operations and invest in research and development to support our growth.

We have generated significant losses from operations and negative cash flows from operating activities in the past as reflected in our accumulated deficit of $256.8$248.7 million as of MarchJune 31,30, 2026. While we did have positive income from operations and positive cash flows in the threesix months ended MarchJune 31,30, 2026, we may be unable to sustain positive income from operations and positive cash flows in future periods. We believe our current cash and cash equivalents will be sufficient to fund our operations for at least the next 12 months. Our future capital requirements, however, will depend on many factors, including our growth rate, the timing and extent of our sales and marketing and research and development expenditures, the continuing market acceptance of our products, and the use of cash to fund potential mergers or acquisitions. In the event that additional financing is required from outside sources, we may seek to raise additional funds through equity, equity-linked arrangements, and debt. If we are unable to raise additional capital when desired and at reasonable rates, our business, results of operations, and financial condition could be adversely affected.