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]

Myriad Genetics FY Conference Summary Company Overview - **Company**: Myriad Genetics (NasdaqGS:MYGN) - **Date of Conference**: September 10, 2025 Key Industry Insights - **Hereditary Cancer Market**: - The affected market (diagnosed with cancer) is valued at approximately $2 billion, with over two-thirds penetration and mid-single-digit growth. [10] - The unaffected market (not diagnosed) is nearing $5 billion, with less than 50% penetration and expected growth between high single digits to low double digits. [10][11] - New guidelines from ASCO and NCCN are expected to drive growth in the affected market. [11] - **Women's Health**: - The Prequel and Foresight volume declined by 7% year-over-year due to issues with the order management system, which have since been resolved. [16][18] - Incremental positive payer coverage for expanded carrier screening has been observed ahead of ACOG guidelines. [19] Core Company Strategies - **Updated Strategy**: - Focus on leveraging strengths in science and high-quality tests, particularly in cancer care. [6][7] - Emphasis on improving user experience and expanding EMR integrations. [7][8] - **Breast Cancer Risk Assessment Program**: - Targeting OB-GYN providers to increase awareness and facilitate hereditary cancer testing. [13][14] - **Partnerships**: - Collaboration with JScreen to enhance access to genetic testing for high-risk populations. [15] Product Developments - **FirstGene**: - A combined screening product for NIPS and carrier screening, currently in early access with positive feedback. [20][21] - **Prequel NIPS**: - Launched for eight weeks of gestational age, showing strong market traction. [23] - **Precise MRD**: - Targeting a 2026 launch with early access to build real-world evidence and customer base. [24][25] - **AI-enabled Prolaris Tests**: - Expected launch by year-end, aimed at improving biopsy confidence and expanding into post-radical prostatectomy opportunities. [29][30] Financial Performance and Projections - **Gross Margins**: - Expected to be in the range of 69.5% to 70% for the year, supported by lab upgrades and operational efficiencies. [41][42] - **Long-term Revenue Growth Target**: - Updated to high single digits to low double digits, driven by growth in hereditary cancer testing, women's health, and oncology. [43][44] - **Operational Expenditure**: - Adjustments made to align with growth strategy, focusing on cancer care while maintaining growth in prenatal and mental health sectors. [46] Challenges and Resolutions - **EMR Integration Issues**: - Challenges in workflow integration for unaffected hereditary cancer testing have been identified and are being addressed through partnerships. [38][39][40] - **Order Management System Disruptions**: - Issues have been resolved, and a gradual return to previous volume levels is expected over the coming quarters. [18][19] Conclusion - Myriad Genetics is positioned in attractive markets with a strong reputation and a focus on innovative product launches. The company is optimistic about future growth driven by strategic partnerships, product development, and operational improvements. [49][50][51]