Company: BLLN
Filing Date: 2025-12-10
Form Type: 10-Q
Source: 0001628280-25-056321
Chunk: 434

Company: BillionToOne, Inc.
Filing Date: 2025-12-10
Form: 10-Q
Item: Part I, Item 8
Chunk 434
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 products, which could force us to lower the list price of our tests and impact our operating margins and our ability to achieve and maintain profitability. In addition, technological innovations that result in the creation of enhanced diagnostic tools that are more effective than ours may enable healthcare providers to deliver specialized diagnostic tests similar to ours in a more patient-friendly, efficient or cost-effective manner than is currently possible. If we cannot compete successfully against current or future competitors, we may be unable to increase or create market acceptance and sales of our products, which could prevent us from increasing or sustaining our revenue or achieving or sustaining profitability.

We have incurred significant losses since inception, and we may not be able to generate sufficient revenue to achieve or maintain profitability.

We have incurred significant losses since our inception. For the years ended December 31, 2023 and 2024, and the nine months ended September 30, 2024, we incurred net losses of $82.7 million, $41.6 million and $30.1 million, respectively; however, we had net income of approximately $1.5 million for the  nine months ended September 30, 2025. As of September 30, 2025 we had an accumulated deficit of $280.7 million. To date, we have financed our operations principally from the sale of preferred stock, convertible securities and debt and revenue generated from our tests. We have devoted substantially all of our resources to the development and commercialization of our smNGS platform and current products, and to sales and marketing and research and development activities. In addition, as a public company, we will incur significant legal, accounting and other expenses that we did not incur as a private company.

While we have been able to achieve gross margin of 24% and 53% for the years ended December 31, 2023 and 2024, and 51% and 67% for the nine months ended September 30, 2024 and 2025, respectively, factors including reimbursement rates, insurance coverage policies, supply chain issues or increased personnel costs could cause our gross margin for existing or new products to decrease. We will need to generate substantial revenue and maintain our gross margin profile to achieve and then sustain profitability, and even if we achieve profitability, we cannot be sure that we will remain profitable for any period of time. While we have recently experienced improvements in our operational efficiency that has contributed to revenue growth, in the future we may not be able to continue to improve operational efficiency or manage costs as we expand