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]

Financial Data and Key Metrics Changes - The company reported Q1 revenue of $196 million, a decline of 3% year over year, at the lower end of the target range [7][10] - Excluding certain impacts, Q1 revenue grew 5% year over year [9][22] - Average revenue per test decreased by 4%, while test volume increased by 1% [22][23] - Gross margin improved by 50 basis points to 69% due to lab efficiencies [23][24] - The company updated its 2025 revenue guidance, lowering it by $35 million from the prior midpoint [10][28] Business Line Data and Key Metrics Changes - Prenatal testing revenue grew by 11% year over year, with strong demand for carrier screening and NIPS tests [12][18] - Oncology revenue declined by 2%, with MiRisk test volume growing by 11% year over year [15][16] - GeneSight revenue decreased by 20% year over year, primarily due to UnitedHealthcare's policy change [19][20] - Women's health revenue increased by 4%, driven by prenatal testing, but was partially offset by weakness in unaffected hereditary cancer testing [18][19] Market Data and Key Metrics Changes - The company faced challenges in the unaffected hereditary cancer testing market due to slower EMR integrations and workflow disruptions [13][14] - The overall demand for oncology tests remains consistent with 2024 trends, despite some confusion over updated NCCN guidelines [17][18] - The company continues to see positive momentum from breast cancer risk assessment programs, although they are not yet at scale [14][19] Company Strategy and Development Direction - The company is focusing on oncology as a cornerstone of its strategy, aiming to serve the continuum of cancer care [29][40] - Plans are in place to reduce overall projected spending while prioritizing investments in high-value new product development [10][11] - The management team is committed to simplifying the business narrative and focusing on core growth areas [38][39] Management's Comments on Operating Environment and Future Outlook - Management acknowledged the challenges faced in 2025 and emphasized the importance of oncology in the company's future [29][39] - The company is optimistic about addressing workflow disruptions and improving test volume growth in the coming quarters [14][39] - Management expressed confidence in the potential for sustained profitable growth and market share increase [30][39] Other Important Information - The company plans to launch several new products, including a combined carrier screening and NIPS assay, and an AI-enabled test by the end of the year [11][12] - An income tax benefit of $29.3 million was recognized in Q1, expected to result in cash tax refunds [25][26] Q&A Session Summary Question: Concerns about the complexity of the company's situation - Management acknowledged the complexity and indicated that it would take several months to simplify the narrative and focus on core growth areas [36][39] Question: Update on GeneSight's revenue headwind - Management confirmed a $10 million revenue headwind in Q1 due to UnitedHealthcare's coverage change, with no expected impact from other payers [46][52] Question: Coverage updates from other payers - Management stated that there have been no indications of coverage changes from other payers and noted some recent wins in coverage [53][54] Question: Impact of UnitedHealthcare on prescription patterns - Management reported no significant changes in provider behavior regarding GeneSight prescriptions despite the coverage changes [55] Question: Details on EMR integration challenges - Management explained that EMR integration for unaffected testing requires additional features and workflows, which take time to implement [68][70] Question: Market growth expectations for Polaris - Management indicated that the market for Polaris is expected to grow at low double-digit rates, with ongoing efforts to enhance competitive positioning [78][79]

Financial Data and Key Metrics Changes - The company reported first quarter revenue of $196 million, a decline of 3% year over year, at the lower end of the target range [5][20] - Excluding certain impacts, total Q1 revenue grew 5% year over year [6][23] - Average revenue per test decreased by 4%, while test volume increased by 1% [20][21] - Gross margin improved by 50 basis points to 69% due to lab efficiencies [21][22] - The company updated its 2025 financial guidance, lowering annual revenue expectations by $35 million and operational expenses by $25 million [7][25] Business Line Data and Key Metrics Changes - Prenatal testing revenue grew by 11% year over year, while hereditary cancer revenue declined by 2% [10][21] - GeneSight revenue decreased by 20% year over year, primarily due to changes in UnitedHealthcare's coverage policy [12][17] - MiRisk test volume grew by 11% year over year, contributing positively to oncology revenue, which declined by 2% overall [12][13] - Women's health revenue reached $87 million, a 4% increase year over year, driven by strong prenatal testing performance [15][16] Market Data and Key Metrics Changes - The company faced headwinds from UnitedHealthcare's policy changes affecting GeneSight, resulting in a $10 million revenue impact in Q1 [43][44] - The overall market for unaffected hereditary cancer testing is projected to grow, but the company is currently experiencing slower ramp-up due to EMR integration challenges [11][64] - The company remains optimistic about the potential for growth in the hereditary cancer market, which is valued at approximately $4.5 billion [54] Company Strategy and Development Direction - The company is focusing on oncology as a cornerstone of its strategy, aiming to enhance its offerings across the cancer care continuum [26][36] - Plans are in place to prioritize investments in high-value new product development, including AI-enabled tests and MRD testing [8][26] - The management team is committed to simplifying the business narrative and focusing on core growth areas [35][36] Management's Comments on Operating Environment and Future Outlook - Management acknowledged a challenging first quarter but expressed optimism about addressing operational challenges and improving performance [5][26] - The company is actively working on strategies to increase test volumes for GeneSight and MiRisk, despite projecting softer volumes for these tests [7][11] - Management emphasized the importance of execution excellence and the need for a compelling strategy to drive future growth [26][36] Other Important Information - The company recognized a one-time income tax benefit of $29.3 million in Q1, expected to result in cash tax refunds [22] - The company is on track to launch several new products, including a combined carrier screening and NIPS assay and an AI-enabled test by the end of the year [8][26] Q&A Session Summary Question: Concerns about the complexity of the company's situation - Management acknowledged the complexity and indicated that it would take several months to simplify the narrative and focus on key growth metrics [33][36] Question: Update on GeneSight's revenue headwind - Management confirmed a $10 million revenue headwind in Q1 due to UnitedHealthcare's coverage changes, with no expected impact from other payers [43][44] Question: Coverage updates from other payers - Management stated that there have been no indications of coverage changes from other payers and noted recent wins in incremental coverage for GeneSight [48] Question: Changes in provider prescription patterns - Management reported no significant changes in provider behavior regarding GeneSight prescriptions, despite the coverage challenges [50] Question: Portfolio evaluation and potential divestitures - Management emphasized a thorough evaluation of the portfolio, with a focus on oncology, while remaining open to strategic adjustments [52][54] Question: EMR integration challenges - Management explained that EMR integration for unaffected testing is complex and requires time to implement effectively [64] Question: Market growth expectations for Polaris - Management indicated that the market for Polaris is expected to grow at low double-digit rates, with ongoing efforts to enhance competitive positioning [72]