8-K
BillionToOne, Inc. (BLLN)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
___________________________________
FORM 8-K
___________________________________
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): December 9, 2025
___________________________________
BillionToOne, Inc.
(Exact name of Registrant as specified in its charter)
___________________________________
| Delaware | 001-42934 | 81-1082020 |
|---|---|---|
| (State or other jurisdiction<br><br>of incorporation) | (Commission<br><br>File Number) | (IRS Employer<br><br>Identification No.) |
1035 O’Brien Drive
Menlo Park, CA 94025
(Address of principal executive offices including zip code)
Registrant’s telephone number, including area code: (650) 460-2551
(Former name or former address, if changed since last report)
___________________________________
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|---|---|
| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading<br><br>Symbol | Name of each exchange<br><br>on which registered |
|---|---|---|
| Class A common stock, par value $0.00001 per share | BLLN | The Nasdaq Stock Market LLC |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and Financial Condition.
On December 9, 2025, BillionToOne, Inc. (the “Company”) issued a press release announcing financial results for the third quarter ended September 30, 2025. A copy of the Company’s press release is attached hereto as Exhibit 99.1.
The information in this Current Report on Form 8-K and the accompanying Exhibit 99.1 shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and is not to be incorporated by reference into any filing by the Company under the Securities Act of 1933, as amended or the Exchange Act, regardless of any general incorporation language contained in such filing, unless otherwise expressly stated in such filing.
Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers
On December 9, 2025, the Company issued a press release announcing that, on December 8, 2025, the board of directors (the “Board”) of the Company increased the size of the Board and the audit committee of the Board (the “Audit Committee”) by one member and appointed Anthony Pagano to the Board and Audit Committee, effective January 1, 2026. Mr. Pagano was appointed as a Class III director and will serve until the Company’s 2028 annual meeting of stockholders and until his successor is elected and qualified, or sooner in the event of his death, resignation or removal. Mr. Pagano was also appointed as chairperson of the Audit Committee, to succeed Thomas Bremner, who will remain a member of the Audit Committee.
The Board has determined that Mr. Pagano meets the requirements for independence under the applicable listing standards of The Nasdaq Stock Market and the Securities Exchange Act of 1934, as amended.
Mr. Pagano will be entitled to receive compensation in the same manner as the Company’s other non-employee directors, pursuant to the Company’s non-employee director compensation policy, as amended from time to time. Mr. Pagano will also enter into the Company’s standard form of indemnification agreement.
There are no arrangements or understandings between Mr. Pagano and any other persons pursuant to which he was elected as a member of the Company’s Board. Mr. Pagano is not a party to any current or proposed transaction with the Company for which disclosure is required under Item 404(a) of Regulation S-K. A copy of the Company’s press release is attached hereto as Exhibit 99.2.
Item 9.01 Financial Statements and Exhibits
(d) Exhibits.
| Exhibit | Description |
|---|---|
| 99.1 | Press Release of BillionToOne, Inc. dated December 9, 2025 |
| 99.2 | Press Release of BillionToOne, Inc. dated December 9, 2025 |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| BillionToOne, Inc. | |||
|---|---|---|---|
| Date: | December 9, 2025 | By: | /s/ Ross Taylor |
| Name: | Ross Taylor | ||
| Title: | Chief Financial Officer |
Document
BillionToOne Reports Third Quarter 2025 Results
MENLO PARK, CA, December 9, 2025 - BillionToOne, Inc. (NASDAQ: BLLN), a next-generation molecular diagnostics company with a mission to create powerful and accurate tests that are accessible to all, today reported its financial results for the third quarter ended September 30, 2025 and initiated guidance for the remainder of 2025.
Recent Financial Highlights:
●Total revenue of $83.5 million in the third quarter of 2025, compared to $38.4 million in the third quarter of 2024, an increase of 117%.
●Prenatal clinical testing revenue was $74.1 million in the third quarter of 2025, an increase of 102% from the third quarter last year.
●Oncology clinical testing revenue was $8.7 million in the third quarter of 2025, which represents an increase of 7.6x compared to $1.1 million in the same period last year and a 76% sequential quarter over quarter increase from $4.9 million in the second quarter of 2025.
●Gross margin was 70% in the third quarter of 2025, compared to 53% in the third quarter of 2024, a 17 percentage-point increase year over year.
●162,900 tests accessioned in the third quarter of 2025, compared to 107,900 tests accessioned in the third quarter of 2024, an increase of 51%.
●Operating income of $9.6 million in the third quarter of 2025, compared to a ($12.6) million operating loss in the third quarter of 2024.
●Positive cash-flow of $6.2 million in the third quarter of 2025.
●Raised gross proceeds of $314.0 million in our initial public offering.
●Expects 2025 full year revenue to be in a range of $293 million to $299 million, which represents 92% to 96% growth over last year; expects fourth quarter 2025 revenue to be in a range of $84 million to $90 million, which represents 86% to 100% growth over the fourth quarter last year.
●Expects positive operating income for both the fourth quarter of 2025 and for the full year 2025.
“This quarter reinforced our view about how a unique, innovative technology combined with disciplined execution can drive a differentiated financial profile in molecular diagnostics,” said Dr. Oguzhan Atay, Co-founder and CEO of BillionToOne. “The incredible strength and momentum across our prenatal and oncology businesses reflects a deliberate commitment to scientific rigor paired with resourceful, step-by-step execution. We continue to earn the trust of providers, patients, payors, and health systems, and rapidly grow our test volumes by solving unmet clinical needs. As we begin our path as a public company, we remain guided by the same principles we started with—relentless focus and an unwavering commitment to re-defining molecular diagnostics.”
| Nine Months Ended | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| September 30, (Unaudited) | |||||||||||
| 2024 | % | 2025 | 2024 | % | |||||||
| Revenue ( in millions) | |||||||||||
| Prenatal | 74.1 | $ | 36.6 | 101 | % | $ | 191.0 | $ | 102.7 | 86 | % |
| Oncology | 8.7 | $ | 1.1 | 664 | % | $ | 15.8 | $ | 1.9 | 754 | % |
| Clinical Trial Support and Other Services | 0.8 | $ | 0.7 | 12 | % | $ | 2.2 | $ | 3.0 | (25 | %) |
| Total Revenue | 83.5 | $ | 38.4 | 117 | % | $ | 209.1 | $ | 107.5 | 153 | % |
| Note: Numbers may not add due to rounding. |
All values are in US Dollars.
| Three Months Ended | Nine Months Ended | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| September 30, (Unaudited) | September 30, (Unaudited) | |||||||||||
| 2025 | 2024 | % | 2025 | 2024 | % | |||||||
| Total tests accessioned | 162,900 | 107,900 | 51 | % | 447,900 | 294,900 | 52 | % | ||||
| Total tests delivered | 165,000 | 108,500 | 52 | % | 440,500 | 289,900 | 52 | % | ||||
| Overall ASP | $ | 501 | $ | 348 | 44 | % | $ | 469 | $ | 361 | 30 | % |
Third Quarter 2025 Financial Results
Total revenue was $83.5 million in the third quarter of 2025 compared to $38.4 million in the third quarter of 2024, an increase of 117%. The increase in total revenues was driven by a 52% increase in the number of total tests delivered and a 44% increase in the company’s overall ASP. Our prenatal delivered test volume grew rapidly in the third quarter of 2025, and growth in delivered test volumes for both our Select and Response oncology tests was also strong.
Gross profit was $58.4 million in the third quarter of 2025, compared to $20.2 million the third quarter of 2024, representing a gross margin of 70% in the third quarter of 2025 and 53% in the third quarter of 2024. Increases in our overall ASP and reductions in our overall cost-per-test drove the improvement in the gross profit margin compared to last year.
Total operating expenses were $48.8 million in the third quarter of 2025, compared to $32.8 million in the third quarter of 2024 an increase of 49%.
Operating income was $9.6 million in the third quarter of 2025, compared to an operating loss of ($12.6) million in the third quarter of 2024. Operating margin was 11.5% in the third quarter of 2025.
Net income available to common shareholders for the third quarter of 2025 was $1.5 million, or $0.10 per diluted share, compared to a net loss of ($14.9) million, or ($1.47) per diluted share, for the third quarter of 2024.
As of September 30, 2025, BillionToOne held approximately $195.2 million in cash and cash equivalents. The Company raised gross proceeds of $314.0 million from its IPO, which closed on November 7, 2025, and received approximately $286.4 million of net proceeds.
Financial Outlook
BillionToOne expects full year 2025 total revenue of $293 million to $299 million, representing growth of 93% to 96% compared to full year 2024.
BillionToOne expects fourth quarter 2025 revenue to be $84 million to $90 million, which represents 86% to 100% growth compared to fourth quarter 2024.
BillionToOne also expects positive GAAP operating income for the fourth quarter of 2025 and for the full year 2025.
Webcast and Conference Call Information
BillionToOne will host a conference call today, December 9, 2025, at 1:30pm Pacific Time / 4:30pm Eastern Time. Investors interested in listening to the conference call are required to register online. A live and archived webcast of the event can be accessed at https://investors.billiontoone.com/.
About BillionToOne
Headquartered in Menlo Park, California, BillionToOne is a molecular diagnostics company with a mission to create powerful and accurate tests that are accessible to all. The company's patented Quantitative Counting Templates™ (QCT™) molecular counting platform is the only multiplex technology that can accurately count DNA molecules at the single-molecule level.
Forward-Looking Statements
This press release contains certain forward-looking statements within the meaning of federal securities laws. These forward-looking statements generally are identified by the words “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “strategy,” “future,” “opportunity,” “plan,” “may,” “should,” “will,” “would,” “will be,” “will continue,” “will likely result,” and similar expressions. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Forward-looking statements in this press release include, but are not limited to, statements regarding revenue, income and other financial information for the fourth quarter of 2025 and the full year of 2025 and expected growth compared to the same periods in 2024. These statements are based on management’s current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors, some of which are beyond BillionToOne’s control. These and additional risks and uncertainties that could affect BillionToOne’s financial and operating results and cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. These risks and uncertainties include those discussed under the captions “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operation” and elsewhere in its prospectus filed with the Securities and Exchange Commission on November 6, 2025. The forward-looking statements in this press release are based on information available to BillionToOne as of the date hereof, and BillionToOne disclaims any obligation to update any forward-looking statements provided to reflect any change in its expectations or any change in events, conditions, or circumstances on which any such statement is based, except as required by law. These forward-looking statements should not be relied upon as representing BillionToOne’s views as of any date subsequent to the date of this press release.
BILLIONTOONE, INC.
Statements of Operations and Comprehensive Income (Loss)
(in thousands, except per share amounts, unaudited)
| Three Months Ended September | Nine Months Ended September | |||||||
|---|---|---|---|---|---|---|---|---|
| 2025 | 2024 | 2025 | 2024 | |||||
| Revenue | $ | 83,523 | $ | 38,419 | $ | 209,059 | $ | 107,505 |
| Cost of revenue | 25,107 | 18,204 | 69,205 | 52,309 | ||||
| Gross profit | 58,416 | 20,215 | 139,854 | 55,196 | ||||
| Operating expenses: | ||||||||
| Research and development | 12,953 | 9,550 | 35,134 | 25,600 | ||||
| Selling, general and administrative | 35,830 | 23,299 | 99,029 | 65,050 | ||||
| Total operating expenses | 48,783 | 32,849 | 134,163 | 90,650 | ||||
| Income (loss) from operations | 9,633 | (12,634) | 5,691 | (35,454) | ||||
| Other income (expense): | ||||||||
| Interest income | 1,535 | 1,952 | 4,492 | 4,148 | ||||
| Interest expense | (20) | (422) | (92) | (2,339) | ||||
| Net (loss) gain on extinguishment of debt | — | (1,346) | — | 7,289 | ||||
| Change in fair value of term loan | (3,936) | (2,283) | (7,038) | (2,283) | ||||
| Change in fair value of convertible notes | — | — | — | (835) | ||||
| Other expense, net | (1,630) | (171) | (1,591) | (614) | ||||
| Total other (expense) income | (4,051) | (2,270) | (4,229) | 5,366 | ||||
| Income (loss) before provision for income taxes | 5,582 | (14,904) | 1,462 | (30,088) | ||||
| Provision for income taxes | (129) | — | (15) | 5 | ||||
| Net income (loss) and comprehensive income (loss) | $ | 5,711 | $ | (14,904) | $ | 1,477 | $ | (30,093) |
| Less: Net income attributable to participating securities | (4,204) | — | (1,089) | — | ||||
| Net income (loss) attributable to common shareholders | 1,507 | (14,904) | 388 | (30,093) | ||||
| Net income (loss) per share, basic and diluted: | ||||||||
| Net income (loss) per share, basic | $ | 0.14 | $ | (1.47) | $ | 0.04 | $ | (2.99) |
| Net income (loss) per share, diluted | $ | 0.10 | $ | (1.47) | $ | 0.03 | $ | (2.99) |
| Weighted-average shares used in calculating net income (loss) per share, basic and diluted: | ||||||||
| Weighted-average shares used in calculating net income (loss) per share, basic | 10,429,583 | 10,107,487 | 10,376,253 | 10,049,097 | ||||
| Weighted-average shares used in calculating net income (loss) per share, diluted | 15,571,949 | 10,107,487 | 15,117,365 | 10,049,097 |
BILLIONTOONE, INC.
Balance Sheets
(in thousands, except share amounts, unaudited)
| September 30,<br>2025 | December 31,<br>2024 | |||
|---|---|---|---|---|
| Assets | ||||
| Current assets: | ||||
| Cash and cash equivalents | $ | 195,152 | $ | 191,477 |
| Accounts receivable | 34,646 | 24,709 | ||
| Inventories | 17,389 | 8,733 | ||
| Prepaid expenses and other current assets | 4,529 | 2,898 | ||
| Total current assets | 251,716 | 227,817 | ||
| Property and equipment, net | 18,667 | 17,111 | ||
| Operating lease right-of-use assets, net | 48,024 | 51,739 | ||
| Other non-current assets | 9,114 | 5,392 | ||
| Total assets | $ | 327,521 | $ | 302,059 |
| Liabilities, redeemable convertible preferred stock, and stockholders’ deficit | ||||
| Current liabilities: | ||||
| Accounts payable | $ | 7,806 | $ | 4,304 |
| Accrued expenses and other current liabilities | 8,041 | 3,882 | ||
| Accrued commissions | 2,922 | 2,756 | ||
| Accrued compensation and employee benefits | 13,687 | 8,419 | ||
| Deferred revenue, current | 2,683 | 2,806 | ||
| Operating lease liabilities, current | 4,902 | 4,393 | ||
| Financing lease liabilities, current | 744 | 1,826 | ||
| Total current liabilities | 40,785 | 28,386 | ||
| Operating lease liabilities, non-current | 47,046 | 50,802 | ||
| Financing lease liabilities, non-current | 460 | 874 | ||
| Long-term debt | 54,986 | 51,481 | ||
| Other non-current liabilities | 4,348 | 2,763 | ||
| Total liabilities | 147,625 | 134,306 | ||
| Commitments and contingencies | ||||
| Redeemable convertible preferred stock, $0.00001 par value; 29,544,989 shares authorized as of December 31, 2024; 29,084,235 shares issued and outstanding as of September 30, 2025 and December 31, 2024; aggregate liquidation preference of $422,458 as of September 30, 2025 and December 31, 2024 | 419,409 | 419,409 | ||
| Stockholders’ deficit: | ||||
| Common stock, $0.00001 par value, 51,100,000 shares authorized as of September 30, 2025 and December 31, 2024; 10,925,950 shares issued and outstanding as of September 30, 2025 and December 31, 2024, respectively | – | – | ||
| Additional paid-in capital | 41,211 | 30,545 | ||
| Accumulated deficit | (280,724) | (282,201) | ||
| Total stockholders’ deficit | (239,513) | (251,656) | ||
| Total liabilities, redeemable convertible preferred stock, and stockholders’ deficit | $ | 327,521 | $ | 302,059 |
Investor Contact
ir@billiontoone.com
Media Contact billiontoone@moxiegrouppr.com
Document
BillionToOne Appoints Anthony Pagano to Board of Directors as Audit Committee Chair
MENLO PARK, Calif., December 9, 2025 – BillionToOne, Inc. (NASDAQ: BLLN), a next-generation molecular diagnostics company with a mission to create powerful and accurate tests that are accessible to all, today announced the appointment of Anthony Pagano to its Board of Directors, effective January 1, 2026. Mr. Pagano will also serve as Chair of the Audit Committee.
Mr. Pagano is currently Chief Financial Officer and Executive Vice President of Genmab, a leading international biotechnology company, a position he has held since March 2020. He joined Genmab in December 2007, establishing a strong track record of driving financial performance and strategic growth throughout his tenure. During Mr. Pagano's tenure, Genmab has grown from $100M in annual revenues to more than $3B, developing, launching and commercializing differentiated and innovative antibody therapeutics that improve the lives of patients.
Before his role at Genmab, Mr. Pagano served as Corporate Controller and Senior Director of Business Planning for NovaDel Pharma, a publicly traded specialty pharma company. He started his professional career at KPMG LLP, where he advanced to Manager and provided audit and mergers & acquisitions consulting services to a diverse client base spanning startups to Fortune 500 corporations across multiple industries.
Mr. Pagano is a Certified Public Accountant and holds a B.S. in Accounting from The College of New Jersey and an M.B.A. from the Stern School of Business at New York University.
"BillionToOne is at the forefront of precision diagnostics, and I am honored to support this important mission," said Anthony Pagano. "Having witnessed the power of innovation in life sciences throughout my career, I am impressed by BillionToOne's technology and team. I look forward to working with the Board and management as the company enters its next phase of growth."
"Anthony's appointment significantly strengthens our Board," said Dr. Oguzhan Atay, co-founder and CEO of BillionToOne and Chairman of the Board. "I believe his deep financial acumen and proven leadership in guiding high-growth life sciences companies will be instrumental in our mission to create a category-defining, transformative molecular diagnostics company."
About BillionToOne
Headquartered in Menlo Park, California, BillionToOne is a next-generation molecular diagnostics company with a mission to create powerful and accurate tests that are accessible to all. The company's patented Quantitative Counting Templates™ (QCT™) molecular counting platform is the only multiplex technology that can accurately count DNA molecules at the single-molecule level. For more information, visit www.billiontoone.com.
Forward-Looking Statements
This press release contains certain forward-looking statements within the meaning of federal securities laws. These forward-looking statements generally are identified by the words “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “strategy,” “future,” “opportunity,” “plan,” “may,” “should,” “will,” “would,” “will be,” “will continue,” “will likely result,” and similar expressions. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Forward-looking statements in
this press release include, but are not limited to, statements regarding the company’s future growth and advancement of its diagnostic technologies. These statements are based on management’s current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors, some of which are beyond BillionToOne’s control. These and additional risks and uncertainties could affect BillionToOne’s financial and operating results and cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. These risks and uncertainties include those discussed under the captions “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operation” and elsewhere in BillionToOne’s prospectus filed with the Securities and Exchange Commission on November 6, 2025. The forward-looking statements in this press release are based on information available to BillionToOne as of the date hereof, and BillionToOne disclaims any obligation to update any forward-looking statements provided to reflect any change in its expectations or any change in events, conditions, or circumstances on which any such statement is based, except as required by law. These forward-looking statements should not be relied upon as representing BillionToOne’s views as of any date subsequent to the date of this press release.
Investor Contact
ir@billiontoone.com
Media Contact
billiontoone@moxiegrouppr.com