Financial Data and Key Metrics Changes - Total revenue for Q3 2025 grew 39% year-over-year to $265.2 million, marking the first time annualized revenue surpassed $1 billion [6][25] - Non-GAAP gross margin improved to 66% in Q3 2025, up from 63% in the prior year, driven by reduced costs [29] - Adjusted EBITDA loss was $45.5 million, an improvement from a loss of $56.2 million in Q3 2024 [30] Business Line Data and Key Metrics Changes - Oncology revenue increased 31% to $184.4 million, with approximately 74,000 tests performed, reflecting a 40% growth in volume [8][25] - Screening revenue from Shield totaled $24.1 million, generated from 24,000 tests, with an average selling price (ASP) of approximately $880 [28] - Biopharma and data revenue grew 18% year-over-year to $54.7 million, supported by two companion diagnostic approvals [27] Market Data and Key Metrics Changes - The screening business is tracking at an annual run rate of approximately $100 million, one year into the commercial launch of the FDA-approved product [6] - Shield tests have shown high adherence rates, with over 90% of ordered cases resulting in completed blood samples [18] Company Strategy and Development Direction - The company aims to expand its commercial infrastructure for Shield, leveraging partnerships with Quest Diagnostics and Path Group to enhance access [19][20] - Continued investment in commercial initiatives and the introduction of new smart applications are expected to drive future growth [14][15] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential inclusion of Shield in American Cancer Society guidelines, which could enhance commercial coverage [40][41] - The company raised its full-year 2025 revenue guidance to $965-$970 million, reflecting stronger-than-expected performance [31][32] Other Important Information - The company surpassed 1 million cumulative clinical patients tested, highlighting the impact of its tests in clinical practice [7] - The submission of the PMA application to the FDA for Guardant360 Liquid is expected to streamline the product offering and enhance market adoption [11] Q&A Session Summary Question: Can you walk us through the Shield ASP dynamics exiting the year? - Management indicated that the ASP for Shield is currently around $1,495, with expectations for continued strong payment from Medicare Advantage [36][37] Question: Is guideline inclusion by the American Cancer Society a real possibility by year-end? - Management remains optimistic about the potential inclusion and its positive impact on reimbursement rates, although it will take time to translate into payments [40][41] Question: How should we think about 2026 growth for Shield? - Management is confident about long-term growth but refrained from providing specific guidance for 2026 at this time [45][46] Question: Can you provide any KPIs around average testing frequency per physician? - Management reported high adherence rates, with over 90% of ordered Shield tests being completed [80]

Financial Data and Key Metrics Changes - Total revenue for Q3 2025 grew 39% year-over-year to $265.2 million, marking the first time annualized revenue crossed $1 billion [4][23] - Non-GAAP gross margin improved to 66% in Q3 2025, up from 63% in the prior year, driven by reduced costs [25][26] - Adjusted EBITDA loss was $45.5 million, an improvement of $10.7 million compared to a loss of $56.2 million in Q3 2024 [27] Business Line Data and Key Metrics Changes - Oncology revenue increased 31% to $184.4 million, with approximately 74,000 tests performed, reflecting a 40% growth [23][24] - Screening revenue from Shield totaled $24.1 million, generated from 24,000 tests, with an average selling price (ASP) of approximately $880 [25][16] - Biopharma and data revenue grew 18% to $54.7 million, including milestone revenue from two companion diagnostic approvals [24][14] Market Data and Key Metrics Changes - The company surpassed 1 million cumulative clinical patients tested, indicating strong market penetration [5] - Shield tests demonstrated high adherence rates, with over 90% of ordered cases resulting in completed blood samples [17][76] Company Strategy and Development Direction - The company aims to expand its commercial infrastructure for Shield, enhancing access and awareness through partnerships with Quest Diagnostics and Path Group [19][18] - Continued investment in commercial initiatives and the introduction of new applications through the Infinity AI platform are expected to drive future growth [12][11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing demand for Shield and the potential for inclusion in American Cancer Society guidelines, which could enhance commercial coverage [39][38] - The company raised its full-year 2025 revenue guidance to a range of $965 to $970 million, reflecting strong year-to-date performance [28][29] Other Important Information - The company achieved a significant milestone by becoming cash flow positive one quarter earlier than expected, excluding the screening business [5][27] - The introduction of an ultra-sensitive tissue-informed MRD assay is anticipated to complement existing offerings and drive growth [13] Q&A Session Summary Question: Can you walk us through the Shield ASP dynamics exiting the year? - Management indicated that the ASP for Shield is currently around $900, with expectations for stability in Medicare rates at $1,495 for the next two years [32][34] Question: Is guideline inclusion by the American Cancer Society a real possibility by year-end? - Management remains optimistic about potential inclusion but noted that it would take time to translate into reimbursement [37][38] Question: What should we expect for Shield growth in 2026? - Management refrained from providing specific guidance for 2026 but expressed confidence in long-term growth prospects [42][44] Question: Can you discuss the traction for Reveal and its future growth? - Management highlighted that Reveal is the fastest-growing oncology product, with ongoing studies expected to enhance its market position [50][52] Question: What is the timeline for MCD FDA approval based on Shield's trajectory? - Management stated it is too early to provide a specific timeline for FDA approval but remains optimistic about the data being collected [47][48]

Summary of Guardant Health 2025 Investor Day Company Overview - **Company**: Guardant Health (NasdaqGS:GH) - **Event**: 2025 Investor Day held on September 24, 2025 - **Focus**: Updates on business progress, innovation, and future strategies in the liquid biopsy market Key Industry Insights - **Liquid Biopsy Market**: Recognized as a significant and growing sector within healthcare, with Guardant Health positioned as a leader - **Market Opportunities**: - Therapy selection: $10 billion market - Minimal residual disease (MRD): $20 billion market - Cancer screening: $50 billion market - Future potential in multi-disease screening Core Company Highlights - **Innovation and Technology**: - Introduction of the Smart Platform, which integrates genomic and epigenomic data to enhance cancer detection and treatment - Expansion of the Shield product offering to include multi-cancer detection results, launching in October 2025 - **Data Generation**: - The company generates approximately 1 petabyte of data per week, with a total of over 200 petabytes expected to reach 1 exabyte in the coming years - The data treasury is crucial for improving test sensitivity and accelerating product development Financial Performance - **Revenue Guidance for 2025**: Approximately $920 million, reflecting a 24% growth year-over-year - **Growth Metrics**: - Two-year compound annual growth rate (CAGR) increased to 28% - Sustained growth driven by adoption in advanced cancer, MRD, and early detection Product and Service Developments - **Guardant360**: Enhanced therapy selection capabilities with increased reimbursement and 15 new applications launched - **MRD Achievements**: Secured CMS reimbursement for colorectal cancer surveillance and reduced cost of goods sold (COGS) by 50% - **Shield Launch**: Positioned to be one of the most successful diagnostic launches in history, with FDA approval and NCCN guideline inclusion Competitive Advantages - **Biobank**: The largest blood-based biobank with over 1 million patient samples, providing a unique competitive edge - **Infinity AI Learning Engine**: Utilizes multimodal data to enhance clinical applications and patient outcomes Future Directions - **Multi-Disease Screening**: Vision to expand beyond cancer detection to include various serious diseases through routine blood testing - **Clinical Research**: Ongoing studies and partnerships to validate the effectiveness of the Smart Platform and its applications in oncology and beyond Additional Insights - **Employee Satisfaction**: 81% of employees rated Guardant as a great place to work, indicating strong internal culture - **Commitment to Patients**: The company emphasizes patient-first values, driving innovation and execution across its product offerings Conclusion - Guardant Health is positioned for significant growth and innovation in the liquid biopsy market, with a strong focus on data-driven solutions and expanding its product portfolio to enhance patient care and outcomes. The company is committed to leveraging its technological advancements and extensive data resources to redefine cancer diagnostics and treatment.

Financial Performance - Tempus AI reported a net loss of $42.8 million in Q2 2025, significantly improved from a net loss of $552.2 million in the same quarter last year [1][8] - Total revenues increased by 89.6% year over year to $314.6 million, driven by a 115% surge in genomics revenues to $241.8 million and a 35.7% increase in Data and Services revenues to $73 million [2][8] - Gross profit rose sharply to $195 million, reflecting a 160% year-over-year increase, attributed to improved cost management and a focus on higher-margin products [3][8] Operational Efficiency - Adjusted EBITDA improved from a negative $16 million in Q1 2025 to a negative $5.6 million in Q2 2025, indicating stronger cost discipline and operational leverage [3] - The company ended the quarter with $293 million in cash and marketable securities, an increase of approximately $70 million from the previous quarter [4] Market Position - Tempus AI's stock has outperformed the industry, with a 41.3% increase over the past year compared to the industry's 17% growth and the S&P 500's 17.4% improvement [7] - The company's current forward Price-to-Sales (P/S) ratio stands at 9.28X, higher than the industry average of 5.83X, indicating a potentially expensive valuation [9] Peer Comparisons - Guardant Health reported a net loss of $99.9 million for Q2 2025, an improvement driven by 31% year-over-year top-line growth and significant gross margin expansion [5] - Exact Sciences reported a net loss of $1.19 million, an improvement of $14.6 million from the previous year, supported by a 16% growth in total revenue and a quarterly gross profit increase of 15.2% [6]

Financial Data and Key Metrics Changes - Q1 2025 total revenue grew 21% year over year to $203.5 million, driven largely by oncology revenue which increased 20% to $150.6 million [6][27] - Non-GAAP gross margin improved to 65% in Q1 2025, up from 63% in Q1 2024, primarily due to improved oncology ASPs and significant reductions in COGS for Reveal and Shield [32] - Adjusted EBITDA loss was $58.5 million for Q1 2025, an improvement from a loss of $61.1 million in Q1 2024 [33] Business Line Data and Key Metrics Changes - Oncology revenue increased 20% year over year to $151 million, with volumes growing 25% to approximately 59,000 tests in Q1 2025 [6][27] - Biopharma and data revenue grew 21% year over year to $45.4 million, supported by increasing partnerships and volume leveraging methylation analysis [15][28] - Screening revenue from Shield totaled $5.7 million in Q1 2025, driven by approximately 9,000 tests [17][29] Market Data and Key Metrics Changes - Guardant360 ASP improved to the range of $3,000 to $3,100 in Q1 2025, compared to approximately $3,000 in Q4 2024, due to better reimbursement from Medicare Advantage and commercial payers [8][27] - Shield received ADLT status, increasing the Medicare price from $920 to $1,495 effective April 1, which is expected to enhance ASP and volume [18][50] Company Strategy and Development Direction - The company aims to support patients throughout their cancer journey, focusing on early detection, monitoring recurrence, and treatment selection [4][5] - Continued investment in EMR integrations is expected to improve ordering depth per account, enhancing overall business performance [8][15] - The launch of upgraded products like Guardant360 Tissue is intended to leverage the smart liquid biopsy platform, providing a comprehensive testing solution [10][11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving cash flow breakeven by 2028, with cumulative free cash outflow projected between $450 million to $550 million over the next three years [34][37] - The company anticipates total oncology volume to grow greater than 25% in 2025, driven by strong product performance and improved reimbursement [35][36] - Management highlighted the importance of both liquid and tissue testing modalities, suggesting that both will be standard care for patients in the future [71] Other Important Information - The company reported that both Reveal and Shield became gross margin positive in Q1 2025, with significant cost reductions achieved [30][31] - The company is focused on cash management and reducing burn rates, with a free cash flow burn of $67 million in Q1 2025, influenced by the timing of annual bonus payouts [33][34] Q&A Session Summary Question: What are the drivers for the accelerated growth in oncology volume? - Management noted strong growth from Guardant360 due to recent product upgrades and the positive market fit for liquid biopsy in therapy selection [42][44] Question: Can you elaborate on the components of the raised guidance for Shield? - Management indicated that improved sales force productivity and the recent ADLT status for Shield contributed to the raised guidance, with expectations for ASP to increase to around $800 [45][50] Question: What is the market share in tissue testing and long-term expectations? - Management acknowledged that the tissue market share is currently small but expects significant growth potential due to the new product's capabilities and market demand [97]

Financial Data and Key Metrics Changes - The company reported Q1 revenue of $203.5 million, a 21% year-over-year increase [7][28] - Oncology revenue grew 20% year-over-year to $150.6 million, with volumes increasing 25% to approximately 59,000 tests [29][30] - Non-GAAP gross margin improved to 65% from 63% year-over-year, driven by better ASPs and reduced costs [34] Business Line Data and Key Metrics Changes - Oncology business revenue increased 20% year-over-year, with Guardant360 and Reveal being the main growth drivers [29][30] - Biopharma and data revenue also grew 21% year-over-year, totaling $45.4 million [31] - Screening revenue from Shield reached $5.7 million, driven by approximately 9,000 tests [32] Market Data and Key Metrics Changes - Guardant360 ASP improved to the range of $3,000 to $3,100, benefiting from better reimbursement rates [9][30] - Shield received ADLT status, increasing its Medicare price from $920 to $1,495, effective April 1 [20][54] - The company expects Shield revenue to be between $40 million and $45 million for 2025, up from previous guidance of $25 million to $30 million [37] Company Strategy and Development Direction - The company aims to support patients throughout their cancer journey, focusing on early detection, monitoring, and treatment selection [5][6] - There is a strong emphasis on expanding the oncology portfolio and enhancing the capabilities of both liquid and tissue tests [12][16] - The company plans to reinvest gross profits from Shield into commercial infrastructure to accelerate growth [40] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving cash flow breakeven by 2028, with cumulative cash outflow expected to be between $450 million and $550 million over the next three years [36][40] - The company anticipates continued growth in oncology volumes and ASPs, driven by recent product upgrades and Medicare coverage [37][39] - Management highlighted the importance of both liquid and tissue testing modalities, suggesting that both will become standard care for patients [72] Other Important Information - The company achieved gross margin positivity for both Reveal and Shield in Q1 2025, with significant cost reductions [32][33] - The Guardant360 Tissue test was launched, requiring 40% less tissue than competitors, enhancing its market appeal [12][71] Q&A Session Summary Question: Can you rank the opportunities for Guardant360's growth? - Management noted strong growth driven by product upgrades and market fit, with Reveal also showing accelerating growth [45][46] Question: What are the components of the raised guidance for Shield? - Management discussed the positive impact of ADLT status and the potential for increased sales force productivity [49][50] Question: What is the ASP for Guardant360 and how does it relate to Medicare? - The ASP for Guardant360 is now expected to be between $3,000 and $3,100, with improvements from Medicare Advantage reimbursements [59][60] Question: What is the market share for the new tissue product? - Management indicated that the new tissue product is expected to capture significant market share due to its unique features and capabilities [98]