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]

Summary of BillionToOne FY Conference Call Company Overview - **Company**: BillionToOne (NasdaqGS: BLLN) - **Industry**: Molecular Diagnostics - **Market Position**: Aiming to be the first molecular diagnostics company to enter the S&P 500 Core Differentiation Pillars 1. **Revolutionary Technology**: - Single molecule next-generation sequencing platform achieving unprecedented sensitivity and precision [2][4] - Patented QCT technology enables single molecule-level sensitivity, leading to superior products in prenatal and oncology testing [2][3] 2. **Rapid Growth**: - Achieved $334 million annualized revenue run rate in five years, with a total addressable market exceeding $100 billion in the U.S. [3][32] - 100% year-over-year growth with a gross margin of 70% [3][28] 3. **GAAP Profitability**: - Achieved GAAP profitability with only 10% of the accumulated deficits of competitors [4][28] - Positive cash flows and operational efficiency driven by AI integration [4][30] 4. **Innovative Product Development**: - Focus on prenatal and oncology diagnostics, addressing limitations in current molecular diagnostics [13][19] - Unique methodologies that differentiate from competitors, particularly in early cancer detection and prenatal testing [11][33] Key Products and Innovations - **Unity Test**: - A non-invasive prenatal test that identifies fetal risk from a maternal blood sample, significantly improving detection rates compared to traditional methods [15][16] - Detects three times as many affected pregnancies compared to existing methodologies [16] - **Northstar Products**: - Therapy selection and monitoring products that detect over 50% more actionable variants than competitors [19][20] - Quantifies tumor burden at a single-molecule resolution, allowing for earlier detection of treatment response [20][22] Market Dynamics and Competitive Landscape - **Market Share**: - Second largest prenatal lab in the U.S. with a growing presence in oncology [33] - Test volume grew 51% year-over-year, with ongoing expansion into health systems [24][41] - **Competitive Advantage**: - Strong data moat from large clinical studies, enabling the identification of causal variants without partner testing [42][43] - Head-to-head clinical data demonstrating superior performance in therapy selection [44] Financial Performance and Projections - **Revenue Growth**: - Projected revenues of $293-$299 million for 2025 and $415-$430 million for 2026 [32] - Historical performance has consistently exceeded projections, indicating strong operational execution [32] - **Cost Management**: - Achieved 70% gross margin with ongoing efforts to reduce COGS through various initiatives [28][30] - Plans to improve ASP through better coding, contracting, and coverage strategies [26][27] Future Outlook - **Growth Strategy**: - Continued investment in sales force and technology integration to enhance market penetration [40][41] - Focus on expanding into MRD testing, targeting a $30 billion market opportunity [33][45] - **Organizational Efficiency**: - Emphasis on productivity and cost management, with a unique approach to clinical studies that reduces expenses compared to competitors [46][47] Conclusion - BillionToOne is positioned to transform the molecular diagnostics landscape with its innovative technology and strong growth trajectory, aiming for significant market share in both prenatal and oncology sectors while maintaining profitability and operational efficiency [34][28]

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 Performance - For the year ended December 31, 2024, the company generated revenue of $152.6 million, representing 113% year-over-year growth, with a gross margin of 53% and a net loss of $41.6 million[141]. - During the nine months ended September 30, 2025, the company generated revenue of $209.1 million, representing 95% year-over-year revenue growth, with a gross margin of 67% and a net income of $1.5 million compared to a net loss of $30.1 million for the same period in 2024[142]. - Revenue for the three months ended September 30, 2025, increased by $45.1 million, or 117%, to $83.5 million compared to $38.4 million for the same period in 2024[180]. - Revenue for the nine months ended September 30, 2025, increased by $101.6 million, or 95%, to $209.1 million compared to $107.5 million in the same period of 2024[197]. - The net income for the three months ended September 30, 2025, was $5.7 million, a significant improvement from a net loss of $14.9 million in the same period of 2024[220]. - Adjusted EBITDA for the nine months ended September 30, 2025, was $18.9 million, compared to a loss of $24.8 million in the same period of 2024[216]. Test Volume and Operations - The total test volume grew to approximately 162,900 tests for the three months ended September 30, 2025, compared to 107,900 tests for the same period in 2024[146]. - The company processed over 562,900 smNGS-based tests within the last 12 months ended September 30, 2025, accounting for more than 50% of the total tests processed since the initial launch[141]. - The total volume of delivered and billable tests rose by 52% to approximately 165,000 for the three months ended September 30, 2025, up from approximately 108,500 in the prior year[181]. - The total volume of delivered and billable tests rose by 52% to approximately 440,500 for the nine months ended September 30, 2025, up from approximately 289,900 in 2024[197]. Gross Profit and Margins - Gross profit increased by $38.2 million, or 189%, resulting in a gross margin of 70% for the three months ended September 30, 2025, compared to 53% in the same period of 2024[185][186]. - Gross profit increased by $84.7 million, or 153%, resulting in a gross margin improvement from 51% in 2024 to 67% in 2025[202][203]. Expenses - Research and development expenses rose by $3.4 million, or 36%, primarily due to increased personnel costs and materials expenses[188]. - Selling, general and administrative expenses increased by $12.5 million, or 54%, driven by higher salaries, commissions, and related expenditures[189]. - Operating expenses rose by $43.5 million, or 48%, totaling $134.2 million for the nine months ended September 30, 2025, driven by increases in research and development and selling, general, and administrative expenses[206][207]. - Research and development expenses increased by $9.5 million, or 37%, primarily due to a rise in personnel costs and materials[206]. - Selling, general and administrative expenses increased by $34.0 million, or 52%, largely due to higher salaries and commissions[207]. Cash and Debt Management - As of September 30, 2025, the company had cash and cash equivalents of $195.2 million and working capital of $210.9 million, following a successful IPO that raised approximately $286.4 million[221]. - The company generated $13.8 million in cash from operating activities during the nine months ended September 30, 2025, compared to cash used of $33.0 million in the same period of 2024[227]. - The company has an accumulated deficit of $280.7 million as of September 30, 2025, despite achieving positive operating income in the nine months ended September 30, 2025[222]. - The company has a debt facility with a total availability of up to $140.0 million, with the first tranche of $50.0 million advanced at an interest rate of 8.0% per annum[223]. - Interest income decreased by $0.4 million, or 21%, primarily due to lower interest rates[190]. - Interest expense decreased by $0.4 million, or 95%, due to the payoff of the Western Alliance Bank debt[192]. - Interest expense decreased by $2.2 million, or 96%, as a result of the payoff of the Western Alliance Bank debt[209]. Future Outlook and Investments - The company expects to maintain significant investment in research and development to enhance existing tests and develop new molecular diagnostic assays[157]. - The company has expanded its laboratory operations by adding a second facility in Union City, CA, and has entered a lease for a new 220,000 square feet laboratory space in Austin, Texas, expected to be operational by 2028[154]. - The company achieved revenue and gross margin thresholds triggering a $30.0 million tranche of notes to be sold by March 31, 2026, based on results from the first half of 2025[224]. Market and Risk Factors - Third-party reimbursement for the company's tests represented more than 90% of revenue for the nine months ended September 30, 2025, highlighting the importance of payor coverage and contracting[150]. - Revenue is primarily derived from third-party insurance carriers, with a new agreement with Johnson & Johnson in 2023 for clinical trial testing, although this revenue is not material to overall operations[245]. - The company is exposed to interest rate risk, but a hypothetical 10% change in interest rates would not have materially impacted financial statements for the years ended December 31, 2023 and 2024[257]. - Inflation has not materially affected the company's financial condition, but significant inflationary pressures could harm business operations and financial results[258]. - International markets contribute less than 1% of revenue, and future expansion may expose the company to foreign currency exchange rate fluctuations[260]. Accounting and Valuation - The company utilizes the Black-Scholes Model to estimate stock-based compensation, which is recognized over the requisite service period[246]. - The fair value of common stock is determined by the Board of Directors, considering various valuation methods and market conditions[248]. - The company is classified as an "emerging growth company," allowing it to delay adopting new accounting standards until they apply to private companies[255]. - The company monitors cash collections against estimated variable consideration, adjusting revenues based on actual experience[244].

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]

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 ...