Company: BLLN
Filing Date: 2025-06-20
Form Type: DRS
Source: 0000950123-25-006095
Chunk: 130

Company: BillionToOne, Inc.
Filing Date: 2025-06-20
Form: DRS
Chunk 130
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D assay. This level of sensitivity suggests our potential ability to develop a highly competitive
tumor-naïve MRD assay using our smNGS platform. Longer-term we believe we may be able to develop products for even larger segments of the oncology diagnostic market, which we estimate represents an annual
market opportunity of over $100 billion in the United States alone.

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. We market our products to health clinics and physicians primarily through our direct sales force. We generally bill directly to an
insurance carrier, patient, or ordering health physician, 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.

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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.

We also derive revenue from a strategic partnership with Johnson & Johnson that utilizes our testing capabilities as part of a project to perform clinical
trials. Revenue from this strategic partnership agreement is recognized as services are performed and tests are delivered, as well as upon the achievement of certain milestones including (i) receipt of approval of the trial, which was achieved
in 2023, (ii) various patient enrollment milestones, and (iii) subsequent full trial completion. Our revenue derived from this agreement 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 and related benefits for its operations and support personnel, shipping costs, overhead allocations, depreciation expense,
facilities-related expenses and other services used in connection delivering the Company’s services.

Gross profit and gross margin

Gross