Company: BLLN
Filing Date: 2025-12-10
Form Type: 10-Q
Source: 0001628280-25-056321
Chunk: 247

Company: BillionToOne, Inc.
Filing Date: 2025-12-10
Form: 10-Q
Item: Part II, Item 1A
Chunk 247
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Item 1A. Risk Factors

A description of risks and uncertainties facing our business is set forth below. You should carefully consider the risks described below, as well as the other information in this Quarterly Report on Form 10-Q (“Quarterly Report”), including our financial statements and the related notes and the section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in this Quarterly Report. Additional risks and uncertainties that we are not currently aware of, or that we currently believe are not material, may also adversely affect our business. This Quarterly Report also contains forward-looking statements that involve risks and uncertainties. See the section titled “Special Note Regarding Forward-Looking Statements.” The occurrence of any of the events or developments described below could harm our business, financial condition, results of operations, and growth prospects. In such an event, the price of our securities could decline, and you may lose all or part of your investment. 

Risk Factors Summary

The following is a summary of the most significant risks, challenges and uncertainties facing our business. This summary should be read in conjunction with the risk factors described below in this section and should not be considered an exhaustive list or summary of all of the significant or material risks, challenges and uncertainties that we face. 

•Our limited operating history and rapid growth make it difficult to evaluate our future prospects and the risks and challenges we may encounter.

•We primarily generate revenue from sales of our molecular diagnostic tests and we are highly dependent on them for our success.

•If the government and other third-party payors fail to provide coverage and adequate payment for our existing and future tests, our revenue and prospects for profitability will be harmed.

•Our revenue may be adversely affected if we are unable to successfully obtain reimbursement from the Medicare program and state Medicaid programs.

•Our billing and claim processing are complex and time-consuming, and any delay in submitting claims or failure to comply with applicable billing requirements could hinder collection and have an adverse effect on our revenue.

•The inherent variability of the insurance coverage and reimbursement landscape makes it difficult to predict amounts we ultimately collect for our tests, and if our estimates of revenue to be recognized materially differs from the revenue recorded for tests, our revenue or operating results may fall below investor or analyst expectations.

•The loss of key members of our senior management team or our inability to attract and retain highly skilled scientists, technicians, clinicians, and sales representatives could adversely affect our business.

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•If our existing laboratory facilities become damaged or inoperable or we are required to