Company: BLLN
Filing Date: 2025-08-11
Form Type: DRS/A
Source: 0000950123-25-007483
Chunk: 143

Company: BillionToOne, Inc.
Filing Date: 2025-08-11
Form: DRS/A
Chunk 143
---
 challenges of early-stage cancer detection. While we have not yet started development in this area, the research work for MRD and our Select and Response tests is 
 a necessary precursor to early detection development. We also believe that there is significant potential for our smNGS platform to accommodate products in this area. We believe the molecular information provided by our tests can assist in                                                                                                                                                                                                                                
 predicting the diagnostic pathway that can confirm the presence and tissue of origin of cancer. Given the capabilities of our existing tests and stated focus of our development efforts, we believe it is reasonable to include early detection in our                                                                                                                                                                                                                        
 calculation of total addressable market opportunity.                                                                                                                                                                                                                                                                                                                                                                                                                           |

Key components of results of operations Revenue The majority of our revenue is derived from sales of our prenatal test, UNITY, and a smaller portion is derived from sales of our liquid biopsy oncology tests, Northstar. Specifically, in 2024, 96% of our revenues were from our prenatal tests, 2% of our revenues were from our oncology tests, and 2% of our revenue was from our clinical trial support services. We market our products to health clinics and physicians or a combination of the 99

insurance carrier and patient for fees. Revenue for tests is recognized when test results are delivered to the ordering physician.

For many health clinics and physicians, the payment we ultimately receive depends upon the rate of reimbursement from insurance carriers. We may also negotiate rates
with patients, if the patient is responsible for payment. Our efforts in obtaining reimbursement based on individual claims, including pursuing appeals or reconsiderations of claim denials, may take a substantial amount of time, and bills may not be
paid for many months or, in some cases, ultimately may not receive payment.

We expect our revenue to increase over time as we expand our sales efforts, introduce
new products, and contract with more payors. In addition, positive reimbursement decisions from insurance carriers would eliminate much of the uncertainty around payment and increase our overall revenue growth from ordering physicians.

We also derive revenue from a strategic partnership with Johnson & Johnson that utilizes our testing capabilities as part of a project to perform clinical
trials. Revenue from this strategic partnership agreement is recognized as services are performed and tests are delivered, as well as upon the achievement of certain milestones including (i) receipt of approval of the trial, which was achieved
in 2023, (ii) various patient enrollment milestones, and (iii) subsequent full trial completion. Our revenue derived from this agreement has not been material to our results of