← Back to BLLN filing summaryThis is the extracted source text from the SEC filing. Formatting may differ from the original document.
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.
Overview
BillionToOne is transforming healthcare by redefining molecular diagnostics. Our revolutionary single-molecule next-generation sequencing (smNGS) platform achieves what was once thought impossible—detecting and precisely quantifying genetic targets with single-molecule sensitivity. At the heart of this technological breakthrough lies our patented quantitative counting templates (QCTs), enabling measurements at the physical limit of detection—the single DNA molecule. This leap forward addresses a fundamental limitation in healthcare—the inability to detect sparse but clinically crucial disease signals in cell-free DNA (cfDNA).
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 more than 1 in 10 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
25
Table of Contents
example, in January 2026, we launched Northstar PGxTM, in February 2026, we launched Northstar Select 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 42% of them, or approximately 726,000 tests, were processed within the last 12 months ended June 30, 2026.
Our key performance metrics
Our revenue is driven by selling and performing molecular diagnostic tests ordered by physicians and other providers. We generally bill the patients’ insurance carrier, Medicaid, Medicare, the patient, or a combination upon delivery of the test results.
Our revenue is the function of two inputs: the number of tests ordered and the ASP that we can achieve through reimbursement. There is a flywheel effect between these two factors. The more tests that we process, the easier it becomes for us to contract with third-party payors and become an in-network provider. This increases our ASP for our tests, as the denial rate of our tests significantly decreases once we become an in-network provider. As we become an in-network provider, it becomes easier for our sales representatives to convince ordering providers to use our tests. We believe that the combined effects of ASP increases, cost of goods sold (COGS) decreases, and improved operational efficiency have been the main drivers of our ability to generate net income in recent periods.
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 197,000 tests for the three months ended June 30, 2026, compared to 148,000 for the three months ended June 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 196,000 tests for the three months ended June 30, 2026, compared to 145,000 delivered and billable tests for the three months ended June 30, 2025.
Key factors affecting our results of operations and performance
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” in our Annual Report on Form 10-K for the year ended December 31, 2025.
Market adoption and commercial success
Our success and future growth depend on maintaining and expanding market acceptance and achieving commercial success in our prenatal and oncology product lines. This requires our sales teams to develop and maintain relationships with obstetricians, maternal-fetal medicine specialists, oncologists, and other providers. In addition, our sales teams must be able to convincingly communicate the clinical utility and value of our tests in enabling personalized patient care. The commercial success of our existing tests and any new tests we develop will depend upon factors such as clinical evidence supporting their effectiveness, inclusion in clinical practice guidelines, adoption by the medical community, favorable coverage by third-party payors, and our ability to differentiate our offerings in competitive markets. In addition, our ability to maintain and expand our sales and marketing capabilities to support increased adoption of our molecular diagnostic solutions will be another key factor to our success.
26
Table of Contents
Payor coverage, contracting, and more effective reimbursement operations
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 six months ended June 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.
Internalizing and strengthening our reimbursement capabilities and incorporating automation and AI to reimbursement operations
We have invested in building a high-performing, specialized team dedicated to all aspects of reimbursement, including claims management, appeals, and payor relations. In July 2023, we transitioned from relying on third-party vendors to managing our reimbursement function in-house. This team’s expertise and commitment have enabled a more consistent, and accurate billing and appeal process, along with the rapid identification and resolution of reimbursement issues.
In addition, we have integrated our internal systems end-to-end, automated many of the repetitive reimbursement procedures, and incorporated AI for significant efficiency improvements (e.g., using large language models (“LLMs”) to read, categorize, and react to thousands of correspondence items from insurance companies that we receive every day), allowing our team to significantly increase their productivity. This strategic move not only streamlines our operations and improves cash flow but also allows us to better advocate for the value of our diagnostic tests with payors by providing rapid feedback and responding proactively to evolving reimbursement trends.
Relentless focus on reducing costs and increasing operational efficiency
Our financial results depend upon our ability to support current and future levels of demand for our prenatal screening and oncology diagnostic tests while maintaining discipline around our cost structure. Historically, we have been able to grow the size of our operational team much more slowly than our test volume increases. This has led to significantly increased operational leverage and efficiencies on a per-test basis and has been a driver in improving our net income (loss) margin.
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, California by adding a second laboratory facility in Union City, California with 90,000 square feet. To further support our growth beyond our current facilities, we entered a lease for the construction of 220,000 square feet of laboratory space in Austin, Texas which includes 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 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.
In addition, we must simultaneously enhance our customer service capabilities, improve our billing and administrative processes, expand our quality assurance programs, incorporate new laboratory equipment and automation, and implement new technology systems, all while maintaining competitive turnaround times. As such, our expenses may increase. In order to maintain cost discipline, we will continue to re-design and optimize our processes, integrate AI into our workflows, and increasingly automate both our laboratory and non-
27
Table of Contents
laboratory operations. We believe that our continued focus in optimization, automation, and AI for higher operational efficiencies will drive further productivity gains.
Continued research and development and new product innovation
We expect to maintain significant levels of investment in research and development as we continue to develop new molecular diagnostic assays, enhance existing tests, and expand our testing capabilities into new clinical applications within our prenatal screening and oncology diagnostics product lines. These investments include costs for new test development, costs to validate new assays or to improve current assays, clinical studies to demonstrate utility and support reimbursement efforts, and development costs for new testing methodologies and platforms. Our ability to develop new products, obtain regulatory approvals for such products when required, successfully launch new products into the market, and drive adoption by healthcare providers will continue to play a key role in our competitive position and financial results. We believe these investments are critical to maintaining our technological leadership, supporting physician adoption, and driving favorable coverage decisions by payors across both our prenatal and oncology product lines.
Key components of results of operations
Revenue
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 six months ended June 30, 2026 and 2025, approximately 88% and 93%, respectively, of our revenue was from our prenatal tests, 11% and 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.
For many health clinics and physicians, the payment we ultimately receive depends upon the rate of reimbursement from insurance carriers. We may also negotiate rates with patients if the patient is responsible for payment. Our efforts in obtaining reimbursement based on individual claims, including pursuing appeals or reconsiderations of claim denials, may take a substantial amount of time, and bills may not be paid for many months or, in some cases, ultimately may not receive payment.
We expect our revenue to increase over time as we expand our sales efforts, introduce new products, and contract with more payors. In addition, positive reimbursement decisions from insurance carriers would eliminate much of the uncertainty around payment and increase our overall revenue growth from ordering physicians.
Our clinical trial support and other services include revenue from strategic partnerships with Johnson & Johnson that utilize our testing capabilities as part of a project to perform clinical trials and the development and commercialization of a companion diagnostic. Revenue from these strategic partnership agreements are recognized as services are performed and costs are incurred. Our revenue derived from these agreements has not been material to our results of operations.
Cost of revenue
Our cost of revenue consists primarily of expenses related to materials and consumables, test kits, personnel-related expenses such as salaries, stock-based compensation expense and related benefits for its operations and support personnel, shipping costs, overhead allocations, depreciation expense, facilities-related expenses and other services used in connection with delivering our services.
Gross profit and gross margin
Gross profit represents revenue less cost of revenue. Gross margin is gross profit expressed as a percentage of revenue. Our gross profit has been, and may in the future be, influenced by several factors, including test volumes and prices paid for our tests, changes in materials and consumables costs, laboratory processing costs, personnel costs, shipping, and logistics costs.
28
Table of Contents
Operating expenses
Research and development expenses
Research and development expenses consist primarily of personnel-related expenses such as salaries, stock-based compensation expense and related benefits for our product development employees. Research and development expenses also include non-personnel costs such as materials and consumables used for research, clinical third-party services and consulting expenses, and an allocation of our general overhead expenses. These costs are expensed in the period they are incurred.
We believe that continued investment in our products is important to our future growth and, as a result, we expect our research and development costs to increase in absolute dollars and moderately decline as a percentage of revenue over time if our revenue increases.
Selling, general and administrative expenses
Selling, general and administrative expenses consist primarily of personnel-related expenses such as salaries, stock-based compensation expense and related benefits for our sales, marketing, and general and administrative employees. Selling, general and administrative expenses also include our commission payments, marketing related expenses in promoting our brand and tests, and training costs for sales employees. All selling, general and administrative costs are expensed in the period as incurred.
We expect selling, general and administrative expenses to increase in absolute dollars as we increase our sales and marketing personnel, increase product offerings, grow our operations and incur additional expenses associated with operating as a public company. These expenses are associated with operating as a public company include expenses necessary to comply with the rules and regulations applicable to companies listed on NASDAQ and related compliance and reporting obligations pursuant to the rules and regulations of the SEC, as well as higher expenses for general and director and officer insurance, investor relations and other professional services.
Other income (expense)
Interest income
Interest income consists of income earned on our short-term cash and cash equivalents which include money market funds.
Interest expense
Interest expense is attributable to interest on our finance leases.
Change in fair value of term loan
Change in fair value of term loan relates to the Oberland Capital debt where we elected the fair value option under ASC 825 and is accounted for at fair value on a recurring basis. We also elected to record interest expense related to the Oberland Capital debt as change in fair value of term loan.
Other income (expense), net
Other 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.
Provision for income taxes
Provision for income taxes consists of U.S. federal and state income taxes. We maintain a full valuation allowance on our federal and state deferred tax assets as we have concluded that it is not more likely than not that the deferred tax assets will be realized.
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.
29
Table of Contents
Results of operations
Comparison of the three months ended June 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:
Three Months Ended June 30, Change
2026 2025 Amount Percent
(in thousands, except percent)
Revenue $ 109,448 $ 66,573 $ 42,875 64.4 %
Cost of revenue(1) 32,341 23,107 9,234 40.0
Gross profit 77,107 43,466 33,641 77.4
Operating expenses:
Research and development(1) 17,315 11,751 5,564 47.3
Selling, general and administrative(1) 54,289 33,342 20,947 62.8
Total operating expenses 71,604 45,093 26,511 58.8
Income (loss) from operations 5,503 (1,627) 7,130 438.2
Other income (expense):
Interest income 4,694 1,451 3,243 223.5
Interest expense (8) (32) 24 (75.0)
Change in fair value of term loan (2,968) (10) (2,958) NM
Other income (expense), net 297 (14) 311 NM
Total other income (expense) 2,015 1,395 620 44.4
Income (loss) before provision for income taxes 7,518 (232) 7,750 NM
Provision for income taxes (536) 14 (550) NM
Net income (loss) and comprehensive income (loss) $ 8,054 $ (246) $ 8,300 NM
NM = Not meaningful
(1) Includes stock-based compensation expense as follows:
Three Months Ended June 30,
2026 2025
(in thousands)
Cost of revenue $ 787 $ 386
Research and development 1,753 823
Selling, general and administrative 5,677 1,523
Total stock-based compensation expense $ 8,217 $ 2,732
Revenue
Revenue increased $42.9 million, or 64%, for the three months ended June 30, 2026 compared to the three months ended June 30, 2025. This increase was driven primarily by a 35% increase in the total volume of delivered and billable tests to approximately 196,000 for the three months ended June 30, 2026 from approximately 145,000 for the three months ended June 30, 2025. The increase in revenue was also attributable to an increase in our Overall ASP of 21%. Overall ASP is the weighted average ASP across all of
30
Table of Contents
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.
We derive our revenue primarily from the number of tests processed and results delivered to the ordering physician. All tests processed are accessioned in our laboratories.
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 June 30, 2026 compared to the same period in the prior year.
Cost of revenue
Cost of revenue increased $9.2 million, or 40%, for the three months ended June 30, 2026 compared to the three months ended June 30, 2025. The increase was primarily due to an increase of $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 $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 and gross margin
Gross profit increased $33.6 million, or 77%, for the three months ended June 30, 2026 compared to the three months ended June 30, 2025. The increase was primarily due to an increase in the number of tests processed and a higher Overall ASP slightly offset by a small increase in Overall Cost Per Test as the sales 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 70% for the three months ended June 30, 2026 from 65% for the three months ended June 30, 2025 for the reasons described above.
The increase in our Overall ASP contributed to all of the improvement of our gross margin for the three months ended June 30, 2026 as compared to the three months ended June 30, 2025. This improvement was partially offset by an increase in our Overall Cost Per Test of 3% for the three months ended June 30, 2026 as compared to the three months ended June 30, 2025. Cost Per Test for both of our oncology products and for our prenatal products declined during the three months ended June 30, 2026 compared to both the three months ended March 31, 2026 and the three months ended June 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 increase in our Overall Cost Per Test.
For the three months ended June 30, 2026 and 2025, our cost of goods sold consisted of 56% of variable costs and 44% of fixed costs, remaining consistent period over period.
Operating expenses
Research and development expenses
Research and development expenses increased $5.6 million, or 47%, for the three months ended June 30, 2026 compared to the three months ended June 30, 2025. The increase was primarily due to a $2.7 million increase in personnel costs which included $0.9 million in stock-based compensation expense, a $1.5 million increase in reagents and supplies costs, a $0.6 million increase in equipment expenses and overhead allocations, a $0.6 million increase in clinical studies expense and a $0.2 million increase in consulting and
31
Table of Contents
other costs. The increase in research and development expenses was primarily driven by an increase in our average research and development headcount of 28 employees during the periods presented to support our product development and innovation efforts.
Selling, general and administrative expenses
Selling, general and administrative expenses increased $20.9 million, or 63%, for the three months ended June 30, 2026 compared to the three months ended June 30, 2025. The increase was primarily due to a $16.9 million increase in salaries, commissions and related expenditure which included $4.2 million in stock-based compensation expense, a $1.6 million increase in professional and consulting fees, a $1.0 million increase in facilities and other costs, a $0.9 million increase in allocated IT and software 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 139 employees during the periods presented to support our sales, marketing and other corporate strategies.
Interest income
Interest income increased $3.2 million, or 224%, for the three months ended June 30, 2026 compared to the three months ended June 30, 2025. The increase was primarily due to a higher average balance of cash and cash equivalents, compared to the three months ended June 30, 2025, due to the proceeds from our IPO in November 2025.
Interest expense
Interest expense decreased $24.0 thousand, or 75%, for the three months ended June 30, 2026 compared to the three months ended June 30, 2025.
Change in fair value of term loan
Change in fair value of term loan increased $3.0 million for the three months ended June 30, 2026 compared to the three months ended June 30, 2025. The increase was due to a change in fair value of the Oberland Capital debt of $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 $0.1 million.
Other income (expense), net
Other income (expense), net increased $0.3 million for the three months ended June 30, 2026 compared to the three months ended June 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 the exercise of the Class A common stock warrants during the three months ended June 30, 2026.
32
Table of Contents
Comparison of the six months ended June 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:
Six Months Ended June 30, Change
2026 2025 Amount Percent
(in thousands, except percent)
Revenue $ 217,836 $ 125,536 $ 92,300 73.5 %
Cost of revenue(1) 61,633 44,098 17,535 39.8
Gross profit 156,203 81,438 74,765 91.8
Operating expenses:
Research and development(1) 32,007 22,181 9,826 44.3
Selling, general and administrative(1) 100,859 63,199 37,660 59.6
Total operating expenses 132,866 85,380 47,486 55.6
Income (loss) from operations 23,337 (3,942) 27,279 692.0
Other income (expense):
Interest income 9,339 2,957 6,382 215.8
Interest expense (18) (72) 54 (75.0)
Change in fair value of term loan (7,229) (3,102) (4,127) 133.0
Other income (expense), net 598 39 559 NM
Total other income (expense) 2,690 (178) 2,868 NM
Income (loss) before provision for income taxes 26,027 (4,120) 30,147 731.7
Provision for income taxes 3 114 (111) (97.4)
Net income (loss) and comprehensive income (loss) $ 26,024 $ (4,234) $ 30,258 714.6
NM = Not meaningful
(1) Includes stock-based compensation expense as follows:
Six Months Ended June 30,
2026 2025
(in thousands)
Cost of revenue $ 1,421 $ 739
Research and development 3,109 1,571
Selling, general and administrative 10,196 2,796
Total stock-based compensation expense $ 14,726 $ 5,106
Revenue
Revenue increased $92.3 million, or 74%, for the six months ended June 30, 2026 compared to the six months ended June 30, 2025. This increase was driven primarily by a 40% increase in the total volume of delivered and billable tests to approximately 384,000 for the six months ended June 30, 2026 from approximately 275,000 for the six months ended June 30, 2025. The increase in revenue was also attributable to an increase in our Overall ASP of 25%. 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 first three months of 2026 and the year ended December 31, 2025. Revenue related to services performed
33
Table of Contents
during the year ended December 31, 2025 that were covered by these payors contributed slightly less than half of the $12.0 million in revenue related to performance obligations satisfied in prior periods for the six months ended June 30, 2026.
The increase in test volume was driven by higher volumes of our prenatal tests primarily as a result of 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 expansion of our oncology sales force. The increase in our ASP per test was driven by several factors. Over the last 12 months we have continued to increase the number of contracts we have with payors for our prenatal tests which drove increases in ASP in the six months ended June 30, 2026 compared to the same period in the prior year. In addition, we continued to benefit from a our proprietary PLA code for our prenatal tests. When utilized, the PLA code is typically reimbursed at a higher rate; this contributed to an increase in ASPs during the six months ended June 30, 2026.
Cost of revenue
Cost of revenue increased $17.5 million, or 40%, for the six months ended June 30, 2026 compared to the six months ended June 30, 2025. The increase was primarily due to an increase of $10.6 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 $6.9 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 and gross margin
Gross profit increased $74.8 million, or 92%, for the six months ended June 30, 2026 compared to the six months ended June 30, 2025. The increase was primarily due to an increase in the number of tests processed and a higher Overall ASP slightly offset by a small increase in Overall Cost Per Test as the sales 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.
Gross margin increased from 65% for the six months ended June 30, 2025 to 72% for the six months ended June 30, 2026 for the reasons described above.
The increase in our Overall ASP contributed to all of the improvement of our gross profit margin for the six months ended June 30, 2026 as compared to the six months ended June 30, 2025, with Overall Cost Per Test staying relatively stable for both periods.
For the six months ended June 30, 2026, our cost of goods sold consisted of 57% of variable costs and 43% of fixed costs and for the six months ended June 30, 2025 our cost of goods sold consisted of 54% of variable costs and 46% of fixed costs. The increase in variable costs during the period was attributable primarily to an increase in test volume from prenatal testing, partially offset by efficiencies gained in our lab from the increased test volume in both prenatal and oncology testing.
Operating expenses
Research and development expenses
Research and development expenses increased $9.8 million, or 44%, for the six months ended June 30, 2026 compared to the six months ended June 30, 2025. The increase was primarily due to a $4.9 million increase in personnel costs which included $1.5 million in stock-based compensation expense, a $2.1 million increase in reagents and supplies costs, a $1.5 million increase in equipment expenses and overhead allocations, a $0.7 million increase in clinical studies expense and a $0.5 million increase in consulting. The increase in research and development expenses was primarily driven by an increase in our average research and development headcount of 27 employees during the periods presented to support our product development and innovation efforts.
Selling, general and administrative expenses
Selling, general and administrative expenses increased $37.7 million, or 60%, for the six months ended June 30, 2026 compared to the six months ended June 30, 2025. The increase was primarily due to a $29.2 million increase in salaries, commissions and related expenditure which included $7.4 million in stock-based
34
Table of Contents
compensation expense, a $3.5 million increase in professional and consulting fees, a $2.3 million increase in facilities and other costs, a $1.7 million increase in allocated IT and software licenses expense and a $1.0 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 133 employees during the periods presented to support our sales, marketing and other corporate strategies.
Interest income
Interest income increased by $6.4 million, or 216%, for the six months ended June 30, 2026 compared to the six months ended June 30, 2025. The increase was primarily due to a higher average balance of cash and cash equivalents, compared to the six months ended June 30, 2025, due to the proceeds from our IPO in November 2025.
Interest expense
Interest expense decreased $0.1 million, or 75%, for the six months ended June 30, 2026 compared to the six months ended June 30, 2025.
Change in fair value of term loan
Change in fair value of term loan increased $4.1 million, or 133% for the six months ended June 30, 2026 compared to the six months ended June 30, 2025. The increase was due to a change in fair value of the Oberland Capital debt of $3.2 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 $0.3 million.
Other income (expense), net
Other income (expense), net increased $0.6 million for the six months ended June 30, 2026 compared to the six months ended June 30, 2025. The increase was primarily due to $0.6 million in other income related to an insurance recovery.
Non-GAAP financial measures
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-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.
35
Table of Contents
EBITDA
We define EBITDA as net income (loss) adjusted for income taxes, interest income, interest expense, and depreciation and amortization expense. A reconciliation of net income (loss), the most directly comparable GAAP financial measure, to EBITDA is presented below (in thousands):
Three Months Ended June 30, Six Months Ended June 30,
2026 2025 2026 2025
Net income (loss) $ 8,054 $ (246) $ 26,024 $ (4,234)
Provision for income taxes (536) 14 3 114
Interest (income) (4,694) (1,451) (9,339) (2,957)
Interest expense 8 32 18 72
Depreciation and amortization 1,829 1,746 3,567 3,540
EBITDA $ 4,661 $ 95 $ 20,273 $ (3,465)
Adjusted EBITDA
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 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. A reconciliation of net income (loss), the most directly comparable GAAP financial measure, to Adjusted EBITDA is presented below (in thousands):
Three Months Ended June 30, Six Months Ended June 30,
2026 2025 2026 2025
Net income (loss) $ 8,054 $ (246) $ 26,024 $ (4,234)
Provision for income taxes (536) 14 3 114
Interest (income) (4,694) (1,451) (9,339) (2,957)
Interest expense 8 32 18 72
Depreciation and amortization 1,829 1,746 3,567 3,540
Stock-based compensation expense 8,217 2,732 14,726 5,106
Change in fair value of term loan 2,968 10 7,229 3,102
Change in fair value of warrant liabilities 297 14 (62) (42)
Adjusted EBITDA $ 16,143 $ 2,851 $ 42,166 $ 4,701
Non-GAAP income (loss) from operations
We define non-GAAP income (loss) from operations as income (loss) from operations presented in accordance with GAAP, adjusted to exclude stock-based compensation expense.
A reconciliation of income (loss) from operations, the most directly comparable GAAP financial measure, to non-GAAP income (loss) from operations is presented below (in thousands):
Three Months Ended June 30, Six Months Ended June 30,
2026 2025 2026 2025
Income (loss) from operations $ 5,503 $ (1,627) $ 23,337 $ (3,942)
Stock-based compensation expense 8,217 2,732 14,726 5,106
Non-GAAP income (loss) from operations $ 13,720 $ 1,105 $ 38,063 $ 1,164
36
Table of Contents
Non-GAAP net income (loss)
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 and comprehensive income (loss), excluding the impact of stock-based compensation expense, change in fair value of the term loan and change in fair value of warrant 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.
A reconciliation of net income (loss), the most directly comparable GAAP financial measure, to non-GAAP net income (loss) is presented below (in thousands):
Three Months Ended June 30, Six Months Ended June 30,
2026 2025 2026 2025
Net income (loss) $ 8,054 $ (246) $ 26,024 $ (4,234)
Stock-based compensation expense 8,217 2,732 14,726 5,106
Change in fair value of term loan 2,968 10 7,229 3,102
Change in fair value of warrant liabilities 297 14 (62) (42)
Non-GAAP net income (loss) $ 19,536 $ 2,510 $ 47,917 $ 3,932
Liquidity and capital resources
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 June 30, 2026, our principal sources of liquidity were cash and cash equivalents of $548.6 million and working capital of $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 $248.7 million as of June 30, 2026. While we did have positive income from operations and positive cash flows in the six months ended June 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.
Oberland Capital note purchase agreement
We have a debt facility with availability of up to $140.0 million, issuable in four separate tranches, pursuant to a Note Purchase Agreement, dated as of August 2, 2024, by and among us, the purchasers party thereto, and BWCB SA LLC (an entity affiliated with Oberland Capital), as purchaser’s agent. The advanced principal accrues interest at a rate of 8.0% per annum. The first tranche of $50.0 million was advanced on August 5, 2024, with a maturity date of August 5, 2031, interest-only payments through August 5, 2031 and a lump sum payment due on August 5, 2031. The lump sum payment includes all of the outstanding principal plus a payment that would generate an internal rate of return ("IRR") for the purchasers of 10.0%. The term loan advances are secured by a lien on our assets.
We were required to sell a tranche of notes in the amount of $30.0 million prior to March 31, 2026 as we achieved the revenue and gross margin thresholds triggering this obligation on June 30, 2025 based on our results for the first half of 2025. The thresholds triggering this tranche were trailing six-month revenue of at least
37
Table of Contents
$112.5 million and a trailing six-month gross margin of at least 45%. The third tranche of $30.0 million was advanced on March 31, 2026, with a maturity date of August 5, 2031, interest-only payments through August 5, 2031 and a lump sum payment due on August 5, 2031. The terms of this tranche are identical to those of the first $50.0 million tranche. We did not elect the option to draw on the fourth tranche.
We have the option at any time to prepay all of the then-outstanding notes, and Oberland Capital has the option to redeem the notes upon a change in control of the Company, an event of default, or maturity. The repayment amount of the note shall equal: (1) 130% of the principal amount if the payment is made within 24 months of issuance; (2) 145% of the principal amount if the payment is made within 36 months of issuance; (3) if the payment is made within 48 months, an amount that would generate an IRR for the purchasers of 12.25%; (4) if the payment is made within 60 months of the issuance, an amount that would generate an IRR for the purchasers of 11.75%; (5) if the payment is made thereafter but prior to maturity, an amount that would generate an IRR for the purchasers of 11.25%; and (6) if the payment is made at maturity, an amount that would generate an IRR for the purchasers of 10.0%.
Beginning with the fiscal quarter ended March 31, 2025, excluding any fiscal quarter in which our aggregate cash and cash equivalents is greater than 1.1 times the aggregate principal amount of the notes issued under the Note Purchase Agreement, we are required to maintain trailing six-month net revenue based on a schedule that gradually increases up to $120.0 million as of December 31, 2026, and a trailing six-month gross margin (as defined in the Note Purchase Agreement) of not less than 30%. As of June 30, 2026, we were in compliance with all financial covenants in the agreement. The Note Purchase Agreement also contains a revenue participation provision, under which, for any fiscal quarter, 0.01% of net revenue for such fiscal quarter (up to $100.0 million of net revenue for each fiscal year) per each $1.0 million principal amount of the notes will be payable to Oberland Capital. The revenue participation payments are additional financing costs of the loan and are included in the computation of the internal rate of return measures described in the preceding paragraph. Beginning with the fiscal year beginning January 1, 2025, we are required to make revenue participation payments under the Note Purchase Agreement.
Cash flows
The following table summarizes our cash flows for the periods presented (in thousands):
Six Months Ended June 30,
2026 2025
Net cash provided by operating activities $ 24,566 $ 3,807
Net cash used in investing activities $ (8,520) $ (5,221)
Net cash provided by (used in) financing activities $ 36,607 $ (1,105)
Operating activities
Net cash provided by operating activities during the six months ended June 30, 2026 was $24.6 million. Net income of $26.0 million included $24.9 million in non-cash charges primarily resulting from $14.7 million of stock-based compensation, $3.6 million of depreciation and amortization, $2.8 million of amortization of right-of-use assets, and aggregate $3.7 million of change in fair value of the common stock warrant liability and term loan. Operating assets had outflows of $38.5 million primarily resulting from a $33.3 million increase in accounts receivable, driven partially by new agreements entered into with payors in 2026, $3.6 million increase in inventory, $1.0 million increase in prepaid expenses and other current assets and a $0.6 million increase in other non-current assets. Operating liabilities had inflows of $12.1 million primarily resulting from a $15.6 million increase in accounts payable and accrued expense balances, offset by a $2.4 million decrease in operating lease liabilities and $1.2 million decrease in deferred revenue.
Net cash provided by operating activities during the six months ended June 30, 2025 was $3.8 million. Net loss of $4.2 million included $11.7 million in non-cash charges primarily resulting from $5.1 million of stock-based compensation, $3.5 million of depreciation and amortization, $2.5 million of amortization of right-of-use assets, and aggregate $0.5 million of change in fair value of the common stock warrant liability, term loan and convertible notes. Operating assets had outflows of $11.0 million primarily resulting from a $5.7 million increase in accounts receivable, $5.0 million increase in inventory, and $2.7 million increase in other non-current assets,
38
Table of Contents
offset by a $2.4 million decrease in prepaid and other current assets. Operating liabilities had inflows of $7.4 million primarily resulting from an $10.1 million increase in accounts payable and accrued expense balances, offset by a $2.1 million decrease in operating lease liabilities and $0.6 million decrease in deferred revenue.
Investing activities
Net cash used in investing activities during the six months ended June 30, 2026 totaled $8.5 million due to purchases of property and equipment.
Net cash used in investing activities during the six months ended June 30, 2025 totaled $5.2 million due to purchases of property and equipment.
Financing activities
Net cash provided by financing activities during the six months ended June 30, 2026 totaled $36.6 million which was comprised of $30.0 million from the draw of the third tranche of the Oberland Debt and $7.4 million in proceeds from the exercise of stock options, offset by $0.5 million of payments of deferred offering costs and $0.3 million of principal payments on finance lease liabilities.
Net cash used in financing activities during the six months ended June 30, 2025 totaled $1.1 million which was comprised of $1.0 million principal payments on finance lease liabilities and $0.6 million of payments of deferred offering costs, offset by $0.5 million in proceeds from the exercise of stock options.
Contractual obligations and commitments
Operating lease commitments. Our operating lease commitments primarily include our labs and corporate offices. As of June 30, 2026, we had fixed lease payment obligations of $67.7 million, with $10.4 million to be paid within 12 months and the remainder thereafter.
Finance lease commitments. Our finance lease commitments primarily relate to equipment used in our labs. As of June 30, 2026, we had fixed lease payment obligations of $0.6 million, with $0.4 million to be paid within 12 months and the remainder thereafter.
Off-balance sheet arrangements
We did not have during the periods presented, and we do not currently have, any off-balance sheet financing arrangements or any relationships with unconsolidated entities or financial partnerships, including entities sometimes referred to as structured finance or special purpose entities, that were established for the purpose of facilitating off-balance sheet arrangements or other contractually narrow or limited purposes.
Critical accounting estimates
We prepare our unaudited financial statements in conformity with GAAP. The preparation of unaudited financial statements in conformity with GAAP required certain estimates and assumptions to be made that may affect our unaudited financial statements. Accounting policies that have a significant impact on our results are described in Note 2 to our unaudited financial statements included in Part 1, Item 1 in this Quarterly Report on From 10-Q. We consider an accounting policy to be critical if the policy is subject to a material level of judgment and if changes in those judgments are reasonably likely to materially impact our results.
We base our estimates and judgments on reasonably available information. Our estimates and assumptions may affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the unaudited financial statements and the reported amounts of revenue and expenses during the reporting period. Actual results may differ from those estimates and such differences may be material to the unaudited financial statements.
We continue to monitor and assess our critical estimates in light of developments, and as new events occur and additional information is obtained, our estimates may change materially in future periods.
For a discussion of our critical accounting estimates, please refer to Item 7 under Part II, “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report on Form 10-K for the year ended December 31, 2025. Since December 31, 2025, there have been no material changes to our critical accounting estimates.
39
Table of Contents
Recent accounting pronouncements
See Note 2 of our unaudited financial statements included in Part 1, Item 1 in this Quarterly Report on From 10-Q for more information regarding recently issued accounting pronouncements.
Emerging growth company status
We are an “emerging growth company” as defined in the JOBS Act. Under the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards until such time as those standards apply to private companies. We have elected to use this exemption from new or revised accounting standards until the earlier of the date we (i) qualify for treatment as an emerging growth company or (ii) affirmatively and irrevocably opt out of the extended transition period provided for emerging growth companies. As a result, our unaudited financial statements may not be comparable to companies that comply with new or revised accounting pronouncements as of public company effective dates.