Company: BLLN
Filing Date: 2025-09-17
Form Type: DRS/A
Source: 0001193125-25-206347
Chunk: 141

Company: BillionToOne, Inc.
Filing Date: 2025-09-17
Form: DRS/A
Chunk 141
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 the NIPT market, and in oncology, we have only just begun. We believe the superiority of our products, combined with our investments in our sales force, marketing infrastructure, enhancements to existing tests, increases in our ASP, and new product development will result in further revenue growth over the coming years. Our strategy is to target large existing markets with our products. We believe the unique capabilities of our smNGS platform enable us to launch superior products in these markets and capture significant market share. We have successfully demonstrated this strategy in the prenatal market, and we are in the earlier phases of repeating this success in the oncology market with our therapy selection (Northstar Select) and therapy response monitoring (Northstar Response) products. We anticipate launching our first assay for MRD detection in 2026, and we believe our smNGS technology has the potential to support our entry into the early cancer detection market longer term. 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 the section titled “Risk factors.”

| • |     | 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 93

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. Our strategies to support our products’ adoption and our commercial success include:

| • |     | Increase geographic coverage: Each field sales representative can effectively cover a small geographic region.                                 
 Adding additional sales representatives enables our sales team to effectively access and convert new