Financial Data and Key Metrics Changes - Total revenue in Q3 2025 was $83.5 million, representing a 117% increase compared to $38.4 million in Q3 2024 [20][25] - Gross margin reached 70% in Q3 2025, a 17 percentage point increase from 53% in Q3 2024 [19][23] - Operating income was $9.6 million in Q3 2025, compared to an operating loss of $12.6 million in Q3 2024, marking the first quarter of positive GAAP operating income [24][25] Business Line Data and Key Metrics Changes - Prenatal revenues were $74.1 million in Q3 2025, growing over 100% year-over-year [21][25] - Oncology revenues increased 7.6 times to $8.7 million in Q3 2025 compared to the same period last year [21][25] - Test volume grew 51% year-over-year to 163,000 tests in Q3 2025 [13][29] Market Data and Key Metrics Changes - The company reported a 51% test growth and 117% revenue growth year-over-year in Q3 2025 [9][10] - The annualized revenue run rate (ARR) reached $334 million in Q3 2025, a $69 million increase sequentially compared to Q2 2025 [16][20] - The company has approximately 235 million contracted lives for payer coverage [17] Company Strategy and Development Direction - The long-term goal is to build a category-defining generational company and become a member of the S&P 500 [9] - The company is focusing on expanding its sales team and investing in electronic medical records (EMR) to enhance adoption in health systems [15][30] - The company aims to maintain capital and operational efficiency while achieving emerging profitability [8][19] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to positively change the trajectory of millions of patients' lives [30] - The company anticipates continued growth momentum despite Q4 being historically a slower quarter [27] - Management highlighted the importance of their unique technology and differentiated products in driving growth [7][10] Other Important Information - The company completed a successful IPO on NASDAQ, raising $314 million in gross proceeds [5] - The company has established an exclusive agreement with Johnson & Johnson for hemolytic disease of fetus and newborn [11] - The company expects total revenue for 2025 to be between $293 million and $299 million, representing a growth of 92% to 96% compared to 2024 [26][27] Q&A Session Summary Question: Plans for positive GAAP net income in 2026 - Management aims to continue growing the company profitably, with specific guidance for 2026 to be provided at a later date [32][33] Question: Timing for Medicare coverage for oncology tests - Management expects the first Medicare coverage for Northstar Response to come before the end of 2026 [34][35] Question: Guidance process and conservatism in forecasts - Management has been operating close to a public company for the last few years and has been conservative in projections [40][41] Question: Impact of EMR investment on business - Management believes EMR integration will significantly accelerate adoption in large health systems [49][51] Question: Clinical spending compared to competitors - Management recognizes the importance of investing in clinical studies but aims to focus on studies that answer specific physician questions [55][56] Question: Mix between monitoring and therapy selection tests - Management indicated a two-to-one ratio for Response tests to Select tests, with most providers using both together [61] Question: Sales force expansion expectations - Management plans to add eight to ten net reps for prenatal and four to six for oncology each quarter [66][67] Question: Contribution of Medicaid coverage to ASP growth - Management noted that incorporating the PLA code into Medicaid coverage can significantly impact ASPs over time [70] Question: Future gross margin expectations - Management expects to maintain gross margins in the high 60s% for the next several quarters [75][78] Question: Timelines for MRD data and indications - Management expects to launch MRD for a pan-cancer indication towards the end of 2026 [88]

BillionToOne (NasdaqGS:BLLN) Q3 2025 Earnings Call December 09, 2025 04:30 PM ET Company ParticipantsRoss Taylor - CFOCasey Woodring - Vice President of Equity ResearchOguzhan Atay - Co-founder, CEO, and Board ChairDavid Deichler - Head of Investor RelationsConference Call ParticipantsTycho Peterson - Managing Director and Senior Equity AnalystMark Massaro - Managing Director and Senior Equity Research AnalystDavid Westenberg - Managing Director and Senior Research AnalystBrandon Couillard - Managing Direct ...

Financial Data and Key Metrics Changes - Total revenue in Q3 2025 was $83.5 million, representing a 117% increase compared to $38 million in Q3 2024 [19][20] - Gross margins reached 70%, a 17 percentage point increase from 53% in Q3 2024 [18][20] - The company achieved positive GAAP operating margin of 11.5% in Q3 2025, marking the first quarter of positive GAAP operating income [22][23] Business Line Data and Key Metrics Changes - Prenatal revenues were $74.1 million, growing over 100% year-over-year, while oncology revenues increased 664% to $8.7 million [15][19] - Total test volume grew 51% year-over-year to 163,000 tests in Q3 2025 [12] - Average selling prices (ASVs) increased by 44% year-over-year to $501 in Q4 2025 [16] Market Data and Key Metrics Changes - The company has approximately 235 million contracted lives, indicating expanded payer coverage [16] - The oncology business is growing faster than the prenatal business, contributing significantly to revenue growth [15] Company Strategy and Development Direction - The long-term goal is to build a category-defining generational company and become a member of the S&P 500 [8] - The company plans to invest more heavily in electronic medical records (EMR) to facilitate adoption in large health systems [13][35] - The focus is on maintaining capital and operational efficiency while achieving profitability [7][24] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in continued growth and profitability, with expectations for positive GAAP operating income in Q4 and for the full year of 2025 [26] - The company anticipates a total revenue of $293 million to $299 million for 2025, representing a growth of 92% to 96% compared to 2024 [24][25] - Management noted that competitive product launches have not impacted business growth so far [12][50] Other Important Information - The company completed a successful IPO, raising $314 million in gross proceeds [4] - Recent publications validate the clinical utility of the company's products, enhancing credibility in the market [10][11] Q&A Session Summary Question: Future GAAP net income expectations - Management aims to continue growing profitably and expects to maintain positive GAAP net income in 2026 [28][29] Question: Timing for oncology test reimbursements - The first Medicare coverage for Northstar Response is expected before the end of 2026 [30] Question: Guidance process as a public company - The company has been operating close to a public company for the last few years and has been conservative in its projections [31][32] Question: Impact of EMR investment - Investing in EMR is expected to significantly accelerate adoption in large health systems [34][35] Question: Clinical spending compared to competitors - Management recognizes the importance of investing in clinical studies but aims to focus on studies that address specific physician needs [38] Question: Mix between monitoring and therapy selection tests - The company sees a two-to-one ratio for Response tests to Select tests, with most providers using both together [41] Question: Sales force expansion plans - The company plans to add 8 to 10 net reps per quarter for prenatal and 4 to 6 for oncology [42][43] Question: Contribution of Medicaid coverage to ASP growth - The integration of Medicaid coverage for the Unity Carrier panel is expected to have a significant long-term impact on ASPs [44] Question: Future gross margin expectations - Management expects to maintain gross margins in the high 60s% for the next several quarters [46][47] Question: MRD timelines and competitive landscape - The company plans to launch MRD tests towards the end of 2026, focusing on tumor-naive MRD [49][50]

MENLO PARK, Calif., Dec. 9, 2025 /PRNewswire/ – 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. Forward-Looking Statements Media Contact [email protected] Mr. Pagano is currently Chief Financial Officer and Executive Vice President ...

MENLO PARK, Calif., Dec. 09, 2025 (GLOBE NEWSWIRE) -- 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 ...

BillionToOne, Inc., (NASDAQ:BLLN) recently completed an upsized initial public offering, or IPO, of 5.23 million shares at $60 each, raising roughly $314 million. The company, a commercial-stage molecular diagnostics company, offers specialized tests in prenatal genetics and oncology.Its patented Quantitative Counting Templates (QCT) platform uses multiplex technology to count DNA molecules at the single-molecule level.How Analysts Reacted “There is strong appetite for high-growth, profitable diagnostic com ...

Exact Sciences (NASDAQ: EXAS) rallied nearly 20% on November 20 after Abbott Laboratories (NYSE: ABT) announced a $21 billion all-cash deal to acquire the molecular diagnostics company. ...

Core Points - BillionToOne, Inc. successfully closed its upsized initial public offering (IPO) of 5,233,765 shares of Class A common stock at a public offering price of $60.00 per share, resulting in gross proceeds of approximately $314.0 million before deductions [1] - The IPO included the full exercise of the underwriters' option to purchase an additional 682,665 shares [1] - The company's Class A common stock began trading on the Nasdaq Global Select Market under the ticker symbol "BLLN" on November 6, 2025 [1] Company Overview - BillionToOne is a molecular diagnostics company headquartered in Menlo Park, California, focused on creating powerful and accurate tests that are accessible to all [4] - The company utilizes a patented technology called Quantitative Counting Templates™ (QCT™), which is the only multiplex technology capable of accurately counting DNA molecules at the single-molecule level [4] Offering Details - The registration statement related to the securities was filed with the U.S. Securities and Exchange Commission and became effective on November 5, 2025 [2] - A prospectus describing the terms of the offering has been filed with the SEC and is available on their website [2]

Core Insights - BillionToOne, Inc. successfully completed an upsized initial public offering (IPO) of 4.6 million shares at $60 per share, raising approximately $273.1 million in gross proceeds [1] - The shares began trading on the Nasdaq Global Select Market on November 6, 2025, with the offering expected to close on November 7, 2025 [1] Company Representation - Gunderson Dettmer has represented BillionToOne through various financing rounds, including Series A and late-stage equity and debt private rounds, providing strategic counsel from early funding to public market entry [2] Underwriters - J.P. Morgan, Piper Sandler, Jefferies, and William Blair are acting as joint book-running managers for the IPO, with Stifel, Wells Fargo Securities, and BTIG also participating as book-running managers [3] Legal Team - The Gunderson deal team included several partners and associates specializing in corporate law and public offerings, showcasing the firm's expertise in navigating complex capital markets [4]

Core Insights - Molecular diagnostics firm BillionToOne successfully raised $273.1 million in its U.S. initial public offering (IPO) [1] - The company priced its shares above the marketed range, indicating strong investor demand [1] Company Summary - BillionToOne specializes in molecular diagnostics, a sector focused on the analysis of biological markers in the genome and proteome [1] - The successful IPO reflects the growing interest and investment in the molecular diagnostics industry [1] Financial Highlights - The total amount raised in the IPO was $273.1 million, showcasing significant capital influx for the company [1] - Pricing of shares above the marketed range suggests a positive market reception and confidence in the company's future prospects [1]