Company: BLLN
Filing Date: 2025-12-10
Form Type: 10-Q
Source: 0001628280-25-056321
Chunk: 277

Company: BillionToOne, Inc.
Filing Date: 2025-12-10
Form: 10-Q
Item: Part II, Item 1A
Chunk 277
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 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 our business. In addition, though we expect that our test volumes and ASPs will increase in the future, our failure to achieve and sustain profitability in the future will make it more difficult to finance our business and accomplish our strategic objectives, which would have a material adverse effect on our business, financial condition and results of operations and cause the market price of our common stock to decline.

Our operating results may fluctuate significantly, which makes our future operating results difficult to predict and could cause our operating results to fall below expectations or any guidance we may provide.

Our quarterly and annual operating results may fluctuate significantly, which makes it difficult for us to predict our future operating results. These fluctuations may occur due to a variety of factors, many of which are outside of our control, including:

•the level of demand for any of our products, which may vary significantly;

•the timing and cost of, and level of investment in, research, development, regulatory compliance or commercialization activities relating to our products, which may change from time to time;

•the introduction of new products or product enhancements by us or others in our industry;

•coverage and reimbursement policies with respect to our products and products that compete with our products;

•expenditures that we may incur to develop or commercialize additional products and technologies;

•changes in governmental regulations including with respect to privacy and data security and CLIA (as defined below), and our compliance therewith;

•future accounting pronouncements or changes in our accounting policies; and

•the impact of natural disasters, political and economic instability, including wars, terrorism, and political unrest, epidemics