Financial Performance - Q1 2025 - Total revenue decreased by 3% year-over-year (YOY) [6, 24], but increased by 5% YOY excluding specific factors like UNH GeneSight impact, EndoPredict divestiture, and a one-time retroactive coverage benefit from Q1 2024 [6] - Adjusted Gross Margin increased by 50 basis points YOY [24], reaching 69% in Q1 2025 [24, 40] - Adjusted Operating Expenses increased by 1% YOY [7, 24], with $140.6 million in Q1 2025 compared to $139.1 million in Q1 2024 [42] - Adjusted EPS was $(0.03) in Q1 2025, compared to $(0.01) in Q1 2024 [24, 45] - Adjusted EBITDA was $(0.1) million in Q1 2025, a decrease from $4 million in Q1 2024 [29, 47] - Adjusted free cash flow was $(18.7) million in Q1 2025, compared to $(17.9) million in Q1 2024 [30, 49] Segment Performance - Q1 2025 - Hereditary Cancer testing (HCT) revenue decreased by 2% YOY [11, 12], while HCT affected population revenue and volume grew by 0% and 5% YOY, respectively [12] - MyRisk with RiskScore testing revenue and volume in the affected population grew by 4% and 11% YOY, respectively [12, 15] - Prenatal revenue increased by 11% YOY [10], driven by Foresight and Prequel (+10% volume growth) [6, 18] - GeneSight testing revenue decreased by 20% YOY [12], while testing volume grew by 2% YOY [12] Updated 2025 Financial Guidance - Total revenue guidance lowered to a range of $807 million - $823 million [32], a $35 million reduction at the midpoint [7] - Adjusted operating expenses guidance moderated to a range of $555 million - $565 million [32], a $25 million reduction at the midpoint [7] - Adjusted EPS guidance midpoint is at breakeven, ranging from $(0.02) to $0.02 [7, 32]

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]

Financial Performance - First quarter 2025 revenue was $196 million, a decline of 3% year-over-year, but increased by 5% when excluding headwinds of $16 million[5]. - Revenue for the three months ended March 31, 2025, was $195.9 million, a decrease of 3.1% compared to $202.2 million in the same period of 2024[25]. - Prenatal revenue grew by 11% year-over-year, while Pharmacogenomics revenue declined by 20% due to UnitedHealthcare's reduced coverage of GeneSight[5]. - The Oncology business generated revenue of $77.7 million in the first quarter of 2025, with hereditary cancer testing volume growing by 5% year-over-year[11]. - The company reported a GAAP net loss of $0.1 million, or $0.00 EPS, with an adjusted EPS of $(0.03) for the first quarter 2025[5]. - The net loss for the three months ended March 31, 2025, was $0.1 million, a significant improvement compared to a net loss of $26.0 million in the prior year[25]. - Adjusted EBITDA for Q1 2025 was $(0.1) million, down from $4.0 million in Q1 2024, reflecting challenges in operational performance[58]. - Adjusted Free Cash Flow for Q1 2025 was $(18.7) million, slightly worse than $(17.9) million in Q1 2024, indicating ongoing cash flow pressures[64]. Margins and Expenses - First quarter 2025 gross margin was 69%, an increase of 40 basis points year-over-year, attributed to greater laboratory efficiencies[5]. - Gross profit for the same period was $134.2 million, down from $137.6 million, resulting in a gross margin of 68.4%[25]. - Adjusted gross profit for the period was $135.1 million, with an adjusted gross margin of 69.0%, compared to 68.5% in the previous year[40]. - Operating expenses for the first quarter of 2025 were $163.2 million, a decrease of $2.3 million year-over-year, while adjusted operating expenses increased to $140.6 million[8]. - Total operating expenses decreased to $163.2 million from $165.5 million year-over-year, with research and development expenses increasing to $27.5 million from $24.9 million[25]. - Real estate optimization costs for Q1 2025 were $4.0 million, down from $6.2 million in Q1 2024, showing improved cost management[64]. - Equity compensation expenses decreased to $9.5 million in Q1 2025 from $11.9 million in Q1 2024, indicating a reduction in non-cash compensation[53]. Cash Flow and Liquidity - Cash flow used in operations was $16.3 million, with adjusted cash flow used in operations at $10.4 million, a decrease of $1.1 million year-over-year[9]. - The company reported a net cash used in operating activities of $16.3 million, an improvement from $18.6 million in the same period last year[30]. - Cash and cash equivalents at the end of the period were $101.0 million, down from $105.6 million at the end of March 2024[30]. Debt and Assets - Long-term debt increased to $59.3 million from $39.6 million year-over-year, indicating a rise in financial leverage[28]. - Total assets decreased to $1,006.1 million from $1,027.6 million, reflecting a reduction in overall company resources[28]. Future Outlook - Updated financial guidance for 2025 includes revenue expectations of $807 - $823 million and adjusted EPS range of $(0.02) - $0.02[5][16]. - The company plans to commercially launch its first AI-driven prostate cancer test by the end of 2025, in partnership with PATHOMIQ[11][32]. Shareholder Impact - Weighted average shares outstanding increased to 91.4 million in Q1 2025 from 89.9 million in Q1 2024, reflecting potential dilution[53]. - The company recognized an uncertain tax benefit of $(28.7) million in Q1 2025, which was not present in Q1 2024, impacting net loss calculations[53]. Other Adjustments - The company reported $1.9 million in other adjustments for Q1 2025, compared to $1.2 million in Q1 2024, indicating increased one-time expenses[64]. - Capital expenditures for Q1 2025 were $5.3 million, down from $6.7 million in Q1 2024, reflecting a reduction in investment spending[64]. - Adjusted Operating Loss for Q1 2025 was $5.5 million, compared to $0.6 million in Q1 2024, indicating a significant increase in losses[48].

Core Insights - Myriad Genetics reported a challenging first quarter of 2025, with mixed performance across its product lines, leading to a reduction in its financial guidance for the year [3][5][17] Financial Performance - First quarter 2025 revenue was $196 million, a decline of 3% year-over-year, but a 5% increase when excluding $16 million in headwinds [5] - Gross margin for the first quarter was 69%, an increase of 40 basis points year-over-year, attributed to improved laboratory efficiencies [5] - The company reported a GAAP net loss of $0.1 million, or $0.00 EPS, influenced by a $29 million tax benefit, while adjusted EPS was $(0.03) [5][12] Product Volumes and Revenue - Total product volumes increased by 1% year-over-year to 385,000 tests, with notable growth in prenatal testing volumes, which rose by 11% [6][5] - Hereditary cancer testing revenue decreased by 2% year-over-year to $86.3 million, while tumor profiling revenue fell by 5% to $29.3 million [5][24] - Pharmacogenomics revenue saw a significant decline of 20% year-over-year, primarily due to UnitedHealthcare's reduction in coverage for GeneSight tests [5][15] Updated Financial Guidance - The updated financial guidance for 2025 includes a revenue range of $807 - $823 million, down from the initial guidance of $840 - $860 million [17] - Adjusted EPS guidance was revised to a range of $(0.02) - $0.02, reflecting the current business outlook [17] Cash Flow and Liquidity - Cash flow used in operations for the first quarter was $16.3 million, with adjusted cash flow used in operations at $10.4 million, a decrease of $1.1 million year-over-year [8] - As of March 31, 2025, the company had cash and cash equivalents of $92 million, with an additional $42 million available under its asset-based credit facility [9] Business Segment Performance - The Oncology segment generated revenue of $77.7 million, while the Women's Health segment contributed $87.2 million in revenue for the first quarter of 2025 [10][11] - MyRisk testing volume in the affected population grew by 11% year-over-year, indicating a positive trend in hereditary cancer testing despite revenue challenges [13] Operational Highlights - Operating expenses for the first quarter were $163.2 million, a slight decrease from the previous year, while adjusted operating expenses increased to $140.6 million [12] - The company is focusing on reducing overall expenditures while prioritizing investments in new product development and revenue growth initiatives [3][5]

Group 1 - Myriad Genetics (NASDAQ: MYGN) is initiated at a Buy rating, indicating a favorable investment opportunity at current stock levels [1] - The stock is trading near multi-year lows around $7, suggesting an attractive risk/reward profile [1] - The valuation implies under 1× forward sales despite the company experiencing double-digit revenue growth [1]

Core Insights - A significant majority of Americans diagnosed with depression and/or anxiety believe mental health medications are effective, yet concerns about side effects prevent over half from taking them [1][2] - Genetic testing for mental health medications is viewed positively, with 54% of patients believing it could alleviate concerns regarding side effects [2][3] Company Overview - Myriad Genetics, Inc. is a leader in molecular diagnostic testing and precision medicine, offering the GeneSight test which analyzes how a patient's genes may influence their response to mental health medications [1][11] - The GeneSight test is recognized as a category-leading pharmacogenomic test for over 60 medications commonly prescribed for psychiatric conditions [11][12] Survey Findings - The GeneSight Mental Health Monitor survey indicates that 62% of patients whose providers did not use PGx testing wished they had been informed about it [3] - The survey also revealed that 67% of Americans believe it is socially acceptable to take medications for mental health, and 66% have a positive view of others taking such medications [8][9] Patient Experience - The case of a patient, Lisa Roberts, illustrates the practical benefits of the GeneSight test in prescribing effective medication without the lengthy trial-and-error process [5][6] - The survey results show that respondents rated the effectiveness of mental health medications similarly to medications for other chronic conditions, such as high blood pressure and high cholesterol [6]

Core Insights - Myriad Genetics is presenting new clinical data on its Precise MRD test for oligometastatic clear-cell renal cell carcinoma (ccRCC) at the AACR Annual Meeting, highlighting its potential in precision medicine [1][4] Group 1: Clinical Data and Findings - The study indicates that metastasis-directed radiation therapy (MDT) can delay or avoid systemic treatments without compromising overall survival, with survival rates of 94% at two years and 87% at three years [4] - The Precise MRD test identified over 50% of patients as MRD-positive at baseline, which is significant given the low tumor fractions typical in ccRCC that often evade detection by earlier MRD tests [4][3] - Patients who tested negative on Precise MRD maintained MDT for a median of 54 months, compared to 27 months for those who tested positive, suggesting a longer duration before initiating aggressive therapy [4] Group 2: Technology and Methodology - Myriad's Precise MRD test is an ultrasensitive, tumor-informed assay that detects circulating tumor DNA (ctDNA) in plasma, utilizing large panels to enhance sensitivity [3][5] - The test employs a novel ranking algorithm to select up to 1,000 high-confidence targets, optimizing panel design for residual disease detection [4] - Including insertion/deletion (INDEL) mutations in MRD panels improves the likelihood of detecting low abundance ctDNA, enhancing sensitivity at low tumor concentrations [4] Group 3: Future Directions and Applications - Myriad continues to develop the Precise MRD assay for various applications, with ongoing evaluations in high-impact studies [4][5] - The company aims to meet the needs of cancer patients, academic partners, and biopharma companies through its advanced testing solutions [6][7]

Core Insights - A study published in the Journal of Clinical Psychopharmacology indicates that the GeneSight Psychotropic Test may lead to fewer psychiatric hospitalizations for patients with major depressive disorder [1][2] Study Findings - The study analyzed data from over 21,000 patients with major depressive disorder who underwent GeneSight testing, linking it to administrative insurance claims [4] - There was a 39% relative reduction in psychiatric-related hospitalizations and a 29% relative reduction in hospitalizations for any reason after GeneSight testing [6] - Patients switched to medications with no or moderate gene-drug interactions experienced a 44% relative reduction in psychiatric hospitalizations [6] GeneSight Test Overview - The GeneSight Psychotropic Test assesses how a patient's genes may affect their response to over 60 commonly prescribed psychiatric medications [5] - The test aims to assist healthcare providers in personalizing medication selection, potentially reducing the trial-and-error process in prescribing [2][5] Company Background - Myriad Genetics is a leader in molecular diagnostics and precision medicine, focusing on improving patient care and reducing healthcare costs through genetic insights [7]

Core Insights - The genetic screening testing market for preventive health is experiencing rapid growth due to technological advancements, increased consumer interest in personalized medicine, and a rise in preventive healthcare strategies [2][3][5]. Market Overview - The market is driven by improvements in genetic testing technologies, such as next-generation sequencing (NGS), which have made tests more accessible, cost-effective, and accurate [3][5]. - Growing consumer awareness of early detection benefits, rising healthcare costs, and a focus on prevention are fueling demand [3][6]. Market Dynamics - The increasing availability of direct-to-consumer genetic tests empowers individuals to manage their health and gain insights into genetic predispositions [4][5]. - Stakeholders include genetic testing companies, healthcare providers, hospitals, diagnostic laboratories, and wellness organizations [4]. Regional Analysis - North America holds the largest market share, driven by technological advancements and high consumer awareness, with the U.S. being a key player [8]. - Europe is characterized by high demand for genetic tests related to cancer and cardiovascular diseases, with significant investments in preventive healthcare [9]. - The Asia-Pacific region is experiencing significant growth due to rising healthcare awareness and investment in healthcare infrastructure, with China and India emerging as key markets [10]. - The Middle East and Africa show emerging opportunities for genetic screening, particularly in the UAE, Saudi Arabia, and South Africa [11]. Competitive Landscape - Key players in the market include Exact Science, Labcorp Genetics Inc., Blueprint Genetics, Ambry Genetics, and others [7]. - The competitive landscape is marked by strategies such as funding activities, mergers and acquisitions, regulatory approvals, and partnerships [18].

SALT LAKE CITY, April 08, 2025 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in molecular diagnostics testing and precision medicine, announced today that in connection with the hiring of Mr. Donnelly as chief commercial officer, previously announced on April 7, 2025, the Board of Directors of Myriad Genetics authorized the grant to Mr. Donnelly of restricted stock units equal to $3.75 million, comprising (i) time-based restricted stock units (RSUs) equal to $2 million and (ii) performa ...