Company: BLLN
Filing Date: 2025-10-07
Form Type: S-1
Source: 0001193125-25-233697
Chunk: 144

Company: BillionToOne, Inc.
Filing Date: 2025-10-07
Form: S-1
Chunk 144
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 cover our tests as well as the amount it will reimburse for such tests. Payors make these determinations based on factors that include medical necessity, clinical utility, and cost-effectiveness. Reimbursement rates vary significantly by test-type, payor, and coverage determination.

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We believe our tests provide significantly greater value than the established Medicare Clinical Laboratory Fee Schedule (CLFS) rates. The current CLFS price established for our sgNIPT is $1,153.62. However, when accounting for the testing cost savings and the savings from earlier clinical intervention made possible by our sgNIPT compared to traditional NIPT, a peer-reviewed study estimated the true value of our test to range from $2,336 (on a healthcare cost-neutral basis, i.e., where the cost savings from reduced time, specialist referrals, fewer paternal and follow-on tests are passed through to the price of the test) to $7,233 (the equivalent cost to identify one affected pregnancy via sequential carrier screening, i.e., where the cost savings from dramatically increasing the number of affected pregnancies identified are passed through to the price of the test). 25We note that CMS determines the price of a test primarily based on an analysis of the costs to provide a test, rather than the intrinsic value it may provide. While our ASPs have significantly increased over time, they are, in aggregate, still less than approximately 50% of the CLFS rates for our tests. This is primarily because (i) we are not in-networkwith all payors, (ii) when we get in-networkwith a payor, we may agree to a rate that is less than 100% of the CLFS in return for more consistent in-networkpayments for our services, and (iii) not all of our tests are considered covered benefits by all payors. As we increase contracting and coverage of our tests, we believe that ASPs can continue to increase over time. Historically, our market access and reimbursement teams have pursued strategies to increasing our ASPs by expanding our payor coverage and reimbursement. We believe these strategies will continue to grow our ASPs over time. Examples include:

| • |     | Securing unique reimbursement and procedural codes: A critical aspect of our market access strategy is to                                                                                                                                           
 obtain specific reimbursement and procedural codes for our tests, rather than using the generic codes that may not fully capture the uniqueness and value that our tests provide. These codes facilitate appropriate billing and reimbursement from 
 payors and drive broader clinical adoption. For instance, our