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]

2025 Q3 Business Update December 9, 2025 Disclaimer & Forward Looking Statement 2025 Q3 Business Update This presentation contains certain "forward-looking statementsˮ within the meaning of applicable securities laws. These statements relate to future events and results of BillionToOne, Inc. (the "Company,ˮ "we,ˮ "us,ˮ or "ourˮ) and involve known and unknown risks, uncertainties and other factors that may cause the actual results, levels of activity, performance or achievements of the Company or its industr ...

Revenue Growth - Total revenue for Q3 2025 was $83.5 million, a 117% increase from $38.4 million in Q3 2024[5] - Prenatal clinical testing revenue reached $74.1 million, up 102% year-over-year, while oncology clinical testing revenue surged to $8.7 million, a 664% increase compared to $1.1 million in the same period last year[5] - The company expects full-year 2025 revenue to be between $293 million and $299 million, representing a growth of 92% to 96% compared to 2024[12] - Fourth quarter 2025 revenue is projected to be between $84 million and $90 million, indicating an 86% to 100% growth compared to Q4 2024[12] Profitability - Gross margin improved to 70% in Q3 2025, up from 53% in Q3 2024, reflecting a 17 percentage-point increase year-over-year[5] - Operating income was $9.6 million in Q3 2025, a significant turnaround from an operating loss of $12.6 million in Q3 2024[10] - Net income available to common shareholders for Q3 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, in Q3 2024[10] - Positive cash flow of $6.2 million was reported in Q3 2025[5] Asset and Liability Management - Total assets increased to $327,521 million as of September 30, 2025, up from $302,059 million on December 31, 2024, representing an increase of 8.5%[19] - Total current assets rose to $251,716 million, compared to $227,817 million at the end of 2024, marking an increase of 10.5%[19] - Total liabilities increased to $147,625 million from $134,306 million, reflecting a rise of 9.9%[19] - Cash and cash equivalents grew to $195,152 million, up from $191,477 million, indicating a 3.5% increase[19] - Accounts receivable surged to $34,646 million, a significant increase from $24,709 million, representing a growth of 40.2%[19] - Inventories increased to $17,389 million, compared to $8,733 million, showing a substantial rise of 99.0%[19] - Long-term debt rose to $54,986 million, up from $51,481 million, which is an increase of 10.0%[19] Stockholder Equity - Total stockholders' deficit improved to $(239,513) million from $(251,656) million, indicating a reduction of 4.8%[19] - Additional paid-in capital increased to $41,211 million from $30,545 million, reflecting a growth of 35.0%[19] - Accumulated deficit slightly improved to $(280,724) million from $(282,201) million, showing a minor reduction of 0.5%[19] Testing Volume - Total tests accessioned in Q3 2025 were 162,900, a 51% increase from 107,900 tests in Q3 2024[7] IPO and Funding - The company raised gross proceeds of $314.0 million from its initial public offering[11]

Core Viewpoint - BillionToOne, Inc. has appointed Anthony Pagano to its Board of Directors, effective January 1, 2026, enhancing its leadership team as it aims for growth in the molecular diagnostics sector [1][5]. Company Overview - BillionToOne is a next-generation molecular diagnostics company headquartered in Menlo Park, California, focused on creating powerful and accurate tests that are accessible to all [6]. - 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 [6]. Leadership Appointment - Anthony Pagano, currently the Chief Financial Officer and Executive Vice President of Genmab, will also serve as Chair of the Audit Committee at BillionToOne [1][2]. - Pagano has a strong track record in financial performance and strategic growth, having contributed to Genmab's revenue growth from $100 million to over $3 billion during his tenure [2]. - His previous experience includes roles at NovaDel Pharma and KPMG LLP, where he provided audit and mergers & acquisitions consulting services [3][4]. Strategic Importance - Pagano's appointment is seen as a significant enhancement to BillionToOne's Board, with expectations that his financial expertise and leadership in high-growth life sciences will be crucial for the company's mission [5].

Core Viewpoint - BillionToOne, Inc. reported strong financial results for Q3 2025, highlighting significant growth in revenue driven by its innovative molecular diagnostics technology, particularly in prenatal and oncology testing [3][5]. Financial Performance - Total revenue for Q3 2025 was $83.5 million, a 117% increase from $38.4 million in Q3 2024 [5][7]. - Prenatal clinical testing revenue reached $74.1 million, up 102% year-over-year, while oncology clinical testing revenue surged to $8.7 million, reflecting a 664% increase [5][7]. - Gross margin improved to 70% in Q3 2025 from 53% in Q3 2024, driven by higher average selling prices (ASP) and reduced costs per test [5][8]. - Operating income was $9.6 million in Q3 2025, compared to an operating loss of $12.6 million in Q3 2024 [9]. Test Volume and ASP - The company accessioned 162,900 tests in Q3 2025, a 51% increase from 107,900 tests in Q3 2024 [4][5]. - The overall ASP increased by 44% to $501 in Q3 2025 compared to $348 in Q3 2024 [6][7]. Cash Flow and IPO - Positive cash flow of $6.2 million was reported in Q3 2025 [5]. - The company raised gross proceeds of $314.0 million from its initial public offering (IPO) [10]. Future Guidance - BillionToOne expects full-year 2025 revenue to be between $293 million and $299 million, indicating growth of 92% to 96% compared to 2024 [11]. - The anticipated revenue for Q4 2025 is projected to be between $84 million and $90 million, representing an 86% to 100% increase year-over-year [11].

Core Viewpoint - BillionToOne, Inc. is set to release its financial results for the third quarter ending September 30, 2025, on December 9, 2025, after market close [1] Group 1: Financial Results Announcement - The financial results will be discussed in a conference call scheduled for 1:30 PM Pacific Time / 4:30 PM Eastern Time on the same day [1] - A live and archived webcast of the conference call will be available on the company's investor relations website [2] Group 2: Company Overview - BillionToOne is headquartered in Menlo Park, California, and focuses on molecular diagnostics [3] - The company aims to create powerful and accurate tests that are accessible to all [3] - BillionToOne's patented Quantitative Counting Templates™ (QCT™) platform is the only multiplex technology capable of accurately counting DNA molecules at the single-molecule level [3]

Core Insights - BillionToOne, Inc. completed an upsized IPO of 5.23 million shares at $60 each, raising approximately $314 million [1] - The company specializes in molecular diagnostics, focusing on prenatal genetics and oncology, utilizing its patented Quantitative Counting Templates (QCT) platform [1] Company Performance - Analysts express strong confidence in BillionToOne's growth potential, citing a robust appetite for high-growth, profitable diagnostic companies [2] - The UNITY test positions the company well in the $2.5 billion U.S. prenatal market, with expectations for continued growth driven by expanded sales reach and greater test awareness [3] - BLLN stock has seen a significant increase of 113% since its IPO, trading at 18 times projected 2026 revenue [4] Analyst Ratings - Stifel has a Buy rating with a price target of $145 [6] - Wells Fargo has an Equal-Weight rating with a price target of $110 [6] - JPMorgan has an Overweight rating with a price target of $150 [6] - Jefferies has a Hold rating with a price target of $117 [6] - BTIG has a Buy rating with a price target of $160 [6]

Core Viewpoint - Several financial institutions have initiated coverage on various companies with positive ratings, indicating strong potential for growth and investment opportunities in their respective markets [1] Group 1: Company Initiations - UBS initiated coverage of Carvana (CVNA) with a Buy rating and a price target of $450, highlighting its "differentiated, best-in-class" online platform and customer experience, which positions it well in the large used vehicle market [1] - Benchmark initiated coverage of Cal-Maine Foods (CALM) with a Buy rating and a price target of $100, suggesting that the company's valuation is undervalued due to its legacy as a commodity producer, despite significant changes in the egg category and a shift towards more valuable specialty production [1] - Goldman Sachs initiated coverage of Beta Technologies (BETA) with a Buy rating and a price target of $47, viewing it as the best positioned among electric vertical take-off and landing companies, with multiple other firms also starting coverage with Buy-equivalent ratings [1] - JPMorgan initiated coverage of BillionToOne (BLLN) with an Overweight rating and a price target of $150, noting the company's potential to build its commercial infrastructure to meet growing demand in prenatal and oncology sectors, with several other firms also starting coverage with Buy-equivalent ratings [1] - Morgan Stanley initiated coverage of Evommune (EVMN) with an Overweight rating and a price target of $36, seeing favorable risk/reward for the shares despite early-stage data for its products, with other firms also starting coverage with Buy-equivalent ratings [1]

Core Viewpoint - Wall Street analysts have initiated coverage of BillionToOne following its recent Nasdaq debut, expressing positive sentiments regarding the company's advanced technology in diagnostics [1] Group 1: Company Overview - BillionToOne is a diagnostics firm that recently went public on Nasdaq, attracting attention from analysts who acted as lead underwriters during its debut [1] Group 2: Analyst Sentiment - Analysts have provided broadly upbeat views on BillionToOne, highlighting the potential of its advanced technology in the diagnostics sector [1]

Core Insights - BillionToOne (BLLN) has been trading for 14 days since its IPO on November 6, indicating a relatively new entry into the market [1] - The stock has established a base with a buy point at 123.84, as per IBD MarketSurge chart analysis tools [1] - Shares broke out on Monday and are currently in a 5% buy zone, which extends up to 130.03 [1] Investment Resources - IBD offers a trial for instant access to exclusive stock lists, expert market analysis, and powerful tools for a limited time [1] - The platform provides market updates, educational videos, webinars, and stock analysis to assist investors [1] - IBD's investing tools and top-performing stock lists aim to enhance investment strategies and profitability [1]