Guardant Health(US:GH)2025-10-29 21:30Financial 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]