Summary of Guardant Health (GH) 2025 Conference Call Company Overview - **Company**: Guardant Health (GH) - **Event**: 2025 Conference on May 14, 2025 - **Speakers**: Helmio Touki (Chairman, Co-Founder, CEO), Amir Aliy Talasaz (Co-Founder, Co-CEO), Mike Bell (CFO) Key Points Industry and Product Performance - **Shield Test**: - 9,000 tests conducted in Q1, exceeding expectations [5] - Volume guidance raised to 52,000 - 58,000 tests for the year, indicating strong launch performance [7][9] - Anticipated revenue of $40 million to $45 million from Shield, potentially one of the largest diagnostic launches [9] - Cost per test reduced from over $1,000 to below $600, with a goal of reaching $200 per test by achieving higher volumes [15][17] - **Shield V2**: - New algorithm developed to improve sensitivity for colorectal cancer detection [19] - Expected FDA submission and potential approval by year-end [20] - **REVEAL Test**: - Positive reimbursement decision for colorectal cancer surveillance, leading to increased volumes [25] - Transitioned from gross margin negative to positive, with ASP over $600 and COGS around $500 [30][31] - **Guardant360 (G360)**: - ASP increased from $2,700 to $3,100, with further growth potential through payer negotiations [41] - Significant growth driven by the launch of a smart liquid biopsy platform [39] Financial Guidance and Profitability - **Financial Outlook**: - Screening business expected to incur a net burn of $200 million over the next two years, with a path to breakeven by 2028 [61][63] - Other segments, including therapy selection and biopharma, are already profitable, contributing to overall financial health [62] Market Position and Strategy - **Comprehensive Portfolio**: - Guardant is positioned uniquely with offerings across screening, MRD, and treatment selection, differentiating itself from competitors [65] - Anticipated integration of services to simplify the ordering process for oncologists [54] - **Future Growth**: - Plans to expand sales force to 700 representatives to enhance nationwide coverage [13] - Continuous investment in automation and workflow efficiencies to further reduce costs [16] Additional Insights - **Multi-Cancer Detection**: - Shield designed as a multi-cancer detection platform, with potential to expand indications beyond colorectal cancer [21] - Selected by the National Cancer Institute for a multi-cancer detection trial [22] - **Clinical Utility and Research**: - Ongoing studies and trials expected to provide additional data readouts, enhancing the clinical utility of tests [35] This summary encapsulates the key insights and developments discussed during the Guardant Health conference call, highlighting the company's strategic direction, product performance, and financial outlook.

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]