Form 8-K

8-K — BillionToOne, Inc.

Accession: 0002070849-26-000029

Filed: 2026-05-06

Period: 2026-05-06

CIK: 0002070849

SIC: 8071 (SERVICES-MEDICAL LABORATORIES)

Item: Results of Operations and Financial Condition

Item: Financial Statements and Exhibits

Documents

8-K — blln-20260506.htm (Primary)

EX-99.1 (a991blln-earningspressrele.htm)

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8-K

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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): May 6, 2026

___________________________________

BillionToOne, Inc.

(Exact name of Registrant as specified in its charter)

___________________________________

Delaware

001-42934

81-1082020

(State or other jurisdiction

of incorporation)

(Commission

File Number)

(IRS Employer

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

Symbol

Name of each exchange

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 May 6, 2026, BillionToOne, Inc. (the “Company”) issued a press release announcing financial results for the quarter ended March 31, 2026. 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 9.01 Financial Statements and Exhibits

(d) Exhibits.

Exhibit

Description

99.1

Press Release of BillionToOne, Inc. dated May 6, 2026

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:

May 6, 2026

By:

/s/ Ross Taylor

Name:

Ross Taylor

Title:

Chief Financial Officer

EX-99.1

Filename: a991blln-earningspressrele.htm · Sequence: 2

Document

BillionToOne Reports First Quarter 2026 Results and Raises 2026 Revenue Guidance

MENLO PARK, CA, May 6, 2026 - 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 first quarter ended March 31, 2026 and raised guidance for full year 2026.

Financial Highlights:

●Total revenue of $108.4 million in the first quarter of 2026, compared to $59.0 million in the first quarter of 2025, an increase of 84%.

●Prenatal clinical testing revenue was $96.5 million in the first quarter of 2026, an increase of 72% from the first quarter of 2025.

●Oncology clinical testing revenue was $10.7 million in the first quarter of 2026, more than four times the $2.2 million reported in the first quarter of 2025.

●Gross profit margin was 73% in the first quarter of 2026, compared to 64% in the first quarter of 2025, a 9 percentage-point increase year-over-year.

●188,000 tests delivered in the first quarter of 2026, compared to 131,000 tests delivered in the first quarter of 2025, an increase of 44%.

●Income from operations of $17.8 million in the first quarter of 2026, compared to a $2.3 million operating loss in the first quarter of 2025.

●Cash flow from operations minus capital expenditures was $11.0 million in the first quarter of 2026.

●Raising 2026 full year revenue guidance to be in a range of $450 million to $465 million, which represents 48% to 52% growth over 2025.

●Expects to operate the business such that it will continue to generate profitability approaching current levels, even with significant continued investments.

Recent Operating Highlights:

●In May, we announced the launch of Unity ConfirmTM, a circulating fetal cell-based, non-invasive confirmation assay designed to enable confirmation of high-risk screening results. The new assay isolates intact circulating fetal cells from a simple maternal blood draw using BillionToOne’s Fetal Cell CaptureTM technology. With the assay, clinicians can confirm a high-risk result from a maternal blood draw without putting the pregnancy at risk from invasive methods such as chorionic villus sampling (CVS) or amniocentesis.

"Our first quarter performance underscores the continued momentum we are building through our differentiated technology platform, category-defining products, and disciplined execution," said Dr. Oguzhan Atay, Co-Founder and CEO of BillionToOne. "In Q1 2026 we launched additional prenatal and oncology offerings and significantly expanded our payor contracts, reaching $300 million contracted lives in the U.S. We remain focused on addressing some of healthcare’s most complex challenges. As we move through 2026, we believe we are only beginning to realize the full potential of our platform.”

Three Months Ended March 31, (Unaudited)

2026 2025 %

Revenue ($ in millions)

Prenatal $ 96.5 $ 56.1 72 %

Oncology $ 10.7 $ 2.2 392 %

Clinical trial support and other services $ 1.1 $ 0.7 61 %

Total Revenue $ 108.4 $ 59.0 84 %

Note: Numbers may not add due to rounding

Three Months Ended March 31, (Unaudited)

2026 2025 %

Total tests accessioned 189,000 137,000 38 %

Total tests delivered 188,000 131,000 44 %

Overall ASP $ 571 $ 445 28 %

First Quarter 2026 Financial Results

Total revenue was $108.4 million in the first quarter of 2026 compared to $59.0 million in the first quarter of 2025, an increase of 84%. The increase in total revenue was driven by a 44% increase in the number of total tests delivered and a 28% increase in Overall ASP. Both prenatal and oncology delivered strong test volume growth year-over-year.

Gross profit was $79.1 million in the first quarter of 2026, compared to $38.0 million in the first quarter of 2025, representing a gross margin of 73% in the first quarter of 2026 and 64% in the first quarter of 2025. An increase in Overall ASP drove the improvement in gross profit margin compared to the first quarter of 2025. Overall cost-per-test remained relatively stable in the first quarter of 2026 compared to last year, as improvements in cost-per-test for both of our oncology products and for our prenatal products were offset by the faster growth of our oncology products, which have higher costs-per-test.

Total operating expenses were $61.3 million in the first quarter of 2026, compared to $40.3 million in the first quarter of 2025 an increase of 52%.

Income from operations was $17.8 million in the first quarter of 2026, compared to a loss from operations of $2.3 million in the first quarter of 2025. Operating margin was 16% in the first quarter of 2026.

Net income in the first quarter of 2026 was $18.0 million, or $0.34 per diluted share, compared to a net loss of $4.0 million, or $(0.39) per diluted share, in the first quarter of 2025.

Financial Outlook

BillionToOne now expects full year 2026 total revenue of $450.0 million to $465.0 million, representing growth of 48% to 52% compared to full year 2025. This compares to the company’s previous guidance of $430 million to $445 million.

BillionToOne also expects to operate the business such that it will continue to generate profitability approaching current levels, even with significant continued investments.

Webcast and Conference Call Information

BillionToOne will host a conference call today, May 6, 2026, 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 for interested listeners 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 full year of 2026. 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 BillionToOne’s most recently filed quarterly report on Form 10-Q, the annual report on Form 10-K and other filings BillionToOne makes with the Securities and Exchange Commission from time to time. 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.

Non-GAAP financial measures

We use certain non-GAAP financial measures to supplement our financial results, which are presented in accordance with GAAP. These non-GAAP financial measures include EBITDA and Adjusted EBITDA. By excluding the impact of certain items that we believe do not directly reflect our underlying operations, we are of the opinion that EBITDA, and Adjusted EBITDA provide meaningful supplemental information regarding our performance. Accordingly, we believe these non-GAAP financial measures are useful to investors and others because they allow for additional information with respect to financial measures used by management in its financial and operational decision-making and forecasting. These metrics also provide investors and other users of our financial information with additional tools to compare business performance across companies and periods, while eliminating the effects of items that may vary for different companies for reasons unrelated to core operating performance. However, there are a number of limitations related to the use of non-GAAP financial measures, and these non-GAAP measures should be

considered in addition to, not as a substitute for or in isolation from, our financial results prepared in accordance with GAAP. Other companies, including companies in our industry, may calculate these non-GAAP financial measures differently or not at all, which reduces their usefulness as comparative measures. A reconciliation between GAAP and non-GAAP financial information is provided immediately following the financial tables. A reconciliation of the forecasted range for adjusted EBITDA for the full year 2026 is not included in this release due to the number of variables in the projected range and because we are currently unable to quantify accurately certain amounts that would be required to be included in the U.S. GAAP measure or the individual adjustments for such reconciliation.

EBITDA

We define EBITDA as net income (loss) adjusted for income taxes, interest income, interest expense, and depreciation and amortization expense.

Adjusted EBITDA

We define Adjusted EBITDA as net income (loss) adjusted for income taxes, interest income, interest expense, depreciation and amortization expense, and certain other items which include significant non-cash items events that are highly variable, significant in size, and that we do not believe are indicative of ongoing or future business operations, which include: stock-based compensation expense; change in fair value of term loan; and change in fair value of warrant liabilities.

BillionToOne, Inc.

Statements of Operations and Comprehensive Income (Loss)

(in thousands, except per share amounts, unaudited)

Three Months Ended

March 31,

2026 2025

Revenue $ 108,388 $ 58,963

Cost of revenue 29,292 20,991

Gross profit 79,096 37,972

Operating expenses:

Research and development 14,692 10,430

Selling, general and administrative 46,570 29,857

Total operating expenses 61,262 40,287

Income (loss) from operations 17,834 (2,315)

Other income (expense):

Interest income 4,645 1,506

Interest expense (10) (40)

Change in fair value of term loan (4,261) (3,092)

Other expense, net 301 53

Total other (expense) income 675 (1,573)

Income (loss) before provision for income taxes 18,509 (3,888)

Provision for income taxes 539 100

Net income (loss) and comprehensive income (loss) $ 17,970 $ (3,988)

Net income (loss) per share, basic and diluted:

Net income (loss) per share, basic $ 0.39 $ (0.39)

Net income (loss) per share, diluted $ 0.34 $ (0.39)

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 45,932,719 10,312,892

Weighted-average shares used in calculating net income (loss) per share, diluted 53,028,360 10,312,892

BillionToOne, Inc.

Balance Sheets

(in thousands, except share amounts, unaudited)

March 31, 2026 December 31, 2025

Assets

Current assets:

Cash and cash equivalents $ 537,450 $ 495,975

Accounts receivable 61,305 41,617

Inventories 19,217 17,545

Prepaid expenses and other current assets 6,166 5,421

Total current assets 624,138 560,558

Property and equipment, net

22,277 20,361

Operating lease right-of-use assets, net

49,396 46,742

Other non-current assets

4,916 4,993

Total assets $ 700,727 $ 632,654

Liabilities and stockholders’ equity

Current liabilities:

Accounts payable $ 8,702 $ 7,184

Accrued expenses and other current liabilities 8,634 7,247

Accrued commissions 3,581 3,912

Accrued compensation and employee benefits 18,283 12,551

Common stock warrant liability 8,924 9,282

Deferred revenue, current 2,796 2,188

Operating lease liabilities, current 5,818 5,079

Financing lease liabilities, current 424 519

Total current liabilities 57,162 47,962

Operating lease liabilities, non-current 47,695 45,723

Financing lease liabilities, non-current 245 348

Deferred revenue, non-current — 1,290

Long-term debt 90,005 57,226

Total liabilities 195,107 152,549

Stockholders’ equity:

Class A common stock, $0.00001 par value, 800,000,000 shares authorized as of March 31, 2026 and December 31, 2025; 41,428,242 and 41,252,105 shares issued and outstanding as of March 31, 2026 and December 31, 2025, respectively

— —

Class B common stock, $0.00001 par value; 10,000,000 shares authorized as of March 31, 2026 and December 31, 2025; 4,552,650 shares issued and outstanding as of March 31, 2026 and December 31, 2025 — —

Additional paid-in capital

764,189 756,644

Accumulated other comprehensive loss (1,792) (1,792)

Accumulated deficit

(256,777) (274,747)

Total stockholders’ equity

505,620 480,105

Total liabilities and stockholders’ equity

$ 700,727 $ 632,654

BillionToOne, Inc.

Statements of Cash Flows

(in thousands, unaudited)

Three Months Ended March 31,

2026 2025

Cash flows from operating activities:

Net income (loss)

$ 17,970 $ (3,988)

Adjustments to reconcile net income (loss) to net cash provided by operating activities:

Stock-based compensation

6,510 2,374

Depreciation and amortization

1,738 1,793

Amortization of operating right-of-use assets

1,252 1,217

Loss on disposal of fixed assets

57 3

Change in fair value of common stock warrant liability

(358) (58)

Change in fair value of redeemable convertible preferred stock warrant liability

- 2

Change in fair value of term loan

2,779 1,797

Changes in operating assets and liabilities:

Accounts receivable

(19,688) (4,881)

Inventories

(1,672) (3,326)

Prepaid expenses and other current assets

(708) 515

Other non-current assets

77 (275)

Accounts payable

1,686 3,218

Accrued expenses and other current liabilities

2,483 1,856

Accrued commissions

(331) 916

Accrued compensation and employee benefits

5,512 2,716

Deferred revenue

(682) (203)

Operating lease liabilities

(1,195) (1,051)

Net cash provided by operating activities 15,430 2,625

Cash flows from investing activities:

Purchases of property and equipment

(4,471) (2,347)

Net cash used in investing activities (4,471) (2,347)

BillionToOne, Inc.

Statements of Cash Flows

(in thousands, unaudited)

Three Months Ended March 31,

2026 2025

Cash flows from financing activities:

Proceeds from issuance of debt 30,000 -

Principal payments on finance lease liabilities

(198) (521)

Payment of deferred offering costs

(504) -

Proceeds from exercise of stock options

1,218 365

Net cash provided by (used in) financing activities 30,516 (156)

Net increase in cash and cash equivalents 41,475 122

Cash and cash equivalents at beginning of period

495,975 191,477

Cash and cash equivalents at end of period

$ 537,450 $ 191,599

Supplemental cash flow disclosure:

Cash payments for interest

$ 1,491 $ 1,334

Cash paid for income taxes

$ 129 $ -

Supplemental non-cash investing and financing activities:

Purchases of property and equipment in accounts payable and accrued expenses and other current liabilities

$ 1,632 $ 1,604

Deferred offering costs in accounts payable and accrued expenses and other current liabilities

$ - $ 237

Right-of-use assets obtained in exchange for new operating lease liabilities

$ 4,010 $ -

Cash paid for amounts included in the measurement of operating lease liabilities

$ 2,368 $ 2,188

Operating cash flows from financing leases (interest paid)

$ 10 $ 39

Exercise of stock options for which cash had not been received $ 40 $ -

Reconciliation of Net Income (Loss) to EBITDA

(in thousands, unaudited)

Three Months Ended

March 31,

2026 2025

Net income (loss) $ 17,970 $ (3,988)

Provision for income taxes 539 100

Interest (income) (4,645) (1,506)

Interest expense 10 40

Depreciation and amortization 1,738 1,793

EBITDA $ 15,612 $ (3,561)

Reconciliation of Net Income (Loss) to Adjusted EBITDA

(in thousands, unaudited)

Three Months Ended

March 31,

2026 2025

Net income (loss) $ 17,970 $ (3,988)

Provision for income taxes 539 100

Interest (income) (4,645) (1,506)

Interest expense 10 40

Depreciation and amortization 1,738 1,793

Stock-based compensation expense 6,510 2,374

Change in fair value of term loan 4,261 3,092

Change in fair value of warrant liabilities (358) (56)

Adjusted EBITDA $ 26,025 $ 1,849

Investor Contact

ir@billiontoone.com

Media Contact

billiontoone@moxiegrouppr.com

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Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act.

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