Company: BLLN
Filing Date: 2025-12-10
Form Type: 10-Q
Source: 0001628280-25-056321
Chunk: 108

Company: BillionToOne, Inc.
Filing Date: 2025-12-10
Form: 10-Q
Item: Part I, Item 4
Chunk 108
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 at least, a three-month inventory of a vast majority of 

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required materials, transitioning suppliers may not always be possible in the future. We estimate replacing suppliers could take approximately one to nine months. If we were to encounter delays or difficulties in securing, reconfiguring or integrating the equipment and reagents we require for our products or in revalidating our products, our business, financial condition, results of operations and reputation could be materially and adversely affected.

Legislative or regulatory developments such as the BIOSECURE Act, proposed in the 118th Congress but not enacted, or the new iteration of the BIOSECURE Act, known colloquially as BIOSECURE 2.0, that was recently added as an amendment to the National Defense Authorization Act in the 119th Congress, could materially affect our business operations, supply chain, or ability to contract with U.S. government agencies. If a statute akin to the BIOSECURE Act or BIOSECURE 2.0 is enacted, in addition to potential other restrictions on our business, it would prohibit federal agencies from contracting with entities that use biotechnology equipment or services from certain foreign entities deemed to be under the control of foreign adversaries.

While we may currently rely, or in the future may rely, on equipment, reagents, or laboratory services from one or more companies that could be designated as “biotechnology companies of concern” under this or similar legislation, we have undertaken and continue to undertake measures to mitigate the risks associated with utilizing material from biotechnology companies of concern. Further, and as a longstanding policy and practice, we utilize robust screening measures to ensure that any genetic data we obtain is protected to the maximum extent under law. If we are unable to verify or restructure our supply chain in compliance with such laws, we could become ineligible for federal contracts, grants, or funding, may be unable to receive reimbursement from Medicaid and Medicare agencies, which provide a substantial percentage of our total revenue, and could face reputational harm, contractual liabilities, or enforcement action.

Even if legislation akin to the BIOSECURE Act or BIOSECURE 2.0 is not enacted, similar legislative or regulatory initiatives may be adopted, and compliance could require significant operational changes, increased costs, or procurement delays. There can be no assurance that we will not be adversely affected by their implementation.

We rely on commercial courier delivery services to transport samples to our facilities in a timely and cost-efficient manner and if these delivery services are disrupted, our business may be harmed.

Our business depends on our