German life sciences tools company Qiagen N.V. (NYSE:QGEN) is reportedly reviewing strategic options, including a potential sale, as renewed takeover interest emerges.The European molecular diagnostics company has engaged advisers while its supervisory board evaluates early-stage approaches from potential suitors, Bloomberg reported on Tuesday, signaling a possible shift after several failed attempts to strike a deal in recent years.Citing people with knowledge of the discussions, the report highlighted tha ...

Core Insights - BillionToOne, Inc. has announced a collaboration with Epic to integrate its prenatal and oncology testing portfolio with Epic's Aura diagnostics suite, enhancing the patient and provider experience [1][2][3] Company Overview - BillionToOne is a next-generation molecular diagnostics company based in Menlo Park, California, focused on creating accessible and accurate tests [5] - The company utilizes a patented Quantitative Counting Templates™ (QCT™) molecular counting platform, which is the only multiplex technology capable of accurately counting DNA molecules at the single-molecule level [5] Integration Details - The integration allows clinicians to order BillionToOne's UNITY Complete® prenatal test and Northstar Select® and Northstar Response® liquid biopsy tests directly within Epic's EHR [2][4] - Test results will flow back into the electronic health record, facilitating clinical decision support and improving the experience for patients and providers across various healthcare settings [2][4] Clinical Impact - UNITY Complete is the first clinically validated non-invasive prenatal test that provides direct fetal risk assessment for multiple conditions from a single maternal blood sample [3] - Northstar Select assists in identifying appropriate therapies for advanced cancer patients, while Northstar Response enables ongoing treatment monitoring [3] User Experience Enhancement - Results will be delivered directly into Epic and accessible through the MyChart patient portal, promoting faster clinical decision-making and a more connected patient experience [4]

JPM Healthcare Conference 2026 Redefining Molecular Diagnostics with Single-Molecule Precision 2 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, p ...

Core Viewpoint - BillionToOne, Inc. has reiterated its full year 2025 revenue guidance of $293 million to $299 million and has initiated its full year 2026 guidance, projecting total revenue of $415 million to $430 million, indicating a growth of 40% to 45% compared to the midpoint of the 2025 guidance [1][4]. Group 1: Financial Guidance - The company expects full year 2026 revenue to be between $415 million and $430 million [4]. - This represents a growth of 40% to 45% compared to the midpoint of the full year 2025 guidance range [4]. - The company anticipates positive GAAP operating income for the full year 2026 [4]. Group 2: 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 [2]. - The company utilizes a patented Quantitative Counting Templates™ (QCT™) molecular counting platform, which is the only multiplex technology capable of accurately counting DNA molecules at the single-molecule level [2]. Group 3: Leadership Perspective - Dr. Oguzhan Atay, Co-founder and CEO, expressed excitement about the opportunity to scale the company's differentiated platform and emphasized a clear roadmap to address significant clinical challenges [2].

Core Viewpoint - BillionToOne, Inc. is set to participate in the 44th Annual J.P. Morgan Healthcare Conference, highlighting its commitment to advancing molecular diagnostics [1] Company Overview - BillionToOne is headquartered in Menlo Park, California, and focuses on creating accessible and accurate molecular diagnostic tests [3] - The company utilizes a patented technology called Quantitative Counting Templates™ (QCT™), which is the only multiplex technology capable of counting DNA molecules at the single-molecule level [3]

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]

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 [20][25] - Gross profit was $58.4 million with a gross margin of 70%, up from 53% in Q3 2024, marking a 17 percentage point increase [23][19] - Operating income was $9.6 million, with a positive GAAP operating margin of 11.5%, compared to an operating loss of $12.6 million in Q3 2024 [24][25] - Net income available to common shareholders 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 same period in 2024 [25] Business Line Data and Key Metrics Changes - Prenatal revenues were $74.1 million, increasing over 100% year-over-year, while oncology revenues grew 664% to $8.7 million [21][16] - Total test accession grew 51% year-over-year to 163,000 tests, driven by expanded geographic coverage and increased commercial density [13][16] - Average selling prices (ASVs) increased significantly, with a blended ASV of $501 in Q4, a 44% year-over-year increase [17] Market Data and Key Metrics Changes - The company has approximately 235 million contracted lives, contributing to the expansion of payer coverage [17] - The oncology business is growing faster than the prenatal business, indicating a shift in market dynamics [16] Company Strategy and Development Direction - The company aims to build a category-defining generational company and become a member of the S&P 500 [9] - Investments are being made in expanding the sales team and enhancing EMR integration to drive growth [30][49] - The company is focused on maintaining capital efficiency while achieving profitability [19] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to continue growing profitably, with expectations for positive GAAP operating income in Q4 and for the full year of 2025 [28] - The company believes it is well-positioned to address a $100 billion market opportunity in the U.S. [8] - Management noted that competitive product launches have not impacted business growth, indicating strong market positioning [14][89] Other Important Information - The company completed a successful IPO, raising $314 million in gross proceeds [5] - The company has established an exclusive agreement with Johnson & Johnson for hemolytic disease of fetus and newborn, enhancing its market position [11] Q&A Session Summary Question: Future GAAP net income expectations - Management aims to continue growing profitably and will provide more guidance at the JPMorgan Healthcare Conference [33] Question: Timing for oncology test reimbursements - The first Medicare coverage for Northstar Select Response is expected before the end of 2026 [35] Question: Guidance process as a public company - The company has been operating close to a public company for years and has been conservative in its projections [39] Question: Impact of EMR investment - EMR integration is expected to significantly accelerate adoption in large health systems, addressing a key barrier to growth [49] Question: Clinical spending compared to competitors - The company recognizes the importance of investing in clinical studies but aims to focus on studies that answer specific physician questions [55] Question: Mix between monitoring and therapy selection tests - There is a two-to-one ratio of response tests to select tests, with most providers using both together [60] Question: Sales force expansion expectations - The company plans to add 8-10 net reps in prenatal and 4-6 in oncology each quarter [65] Question: Contribution of Medicaid to ASP growth - The carrier code's incorporation into Medicaid coverage can significantly impact ASPs, although the full effect will take time to materialize [68]

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]

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].