Core Insights - Myriad Genetics announced new clinical data from the MONSTAR-SCREEN-3 study, demonstrating the effectiveness of its ultra-sensitive Precise™ MRD Test in detecting circulating tumor DNA (ctDNA) across various cancer types [1][2] - The study achieved 100% baseline detection of ctDNA and found that 60% of patients testing positive one month post-surgery had ctDNA levels only detectable via the ultra-sensitive test [2] Study Findings - The MONSTAR-SCREEN-3 study involved approximately 1,200 patients across more than 20 cancer types, focusing on the application of MRD monitoring using Precise MRD [3] - The study aims to provide high-quality clinical evidence for the broad application of MRD testing, particularly in low-shedding tumors [3] - ctDNA levels are assessed at multiple time points, including diagnosis, post-neoadjuvant therapy, and post-surgery, with follow-ups every 3-6 months for at least two years [3] Test Details - Myriad's Precise MRD test is a tumor-informed, whole-genome sequencing (WGS)-based test that monitors hundreds to thousands of tumor-specific variants, offering exceptional sensitivity in ctDNA detection [4][5] - The test can detect tumor fractions as low as 0.0001% (1 part per million) and has shown a clinically meaningful lead time in detecting recurrence compared to imaging [5] Clinical Implications - The results indicate that ctDNA status after neoadjuvant treatment is strongly associated with pathological response, highlighting the potential for personalized treatment strategies [2][5] - The enhanced sensitivity of the Precise MRD test allows for better monitoring and treatment planning for patients with low-shedding tumors, such as breast and renal cancers [2][4]

Core Insights - Myriad Genetics will present data from seven new research studies at the 2025 ASCO Annual Meeting, focusing on Molecular Residual Disease (MRD) clinical outcomes from the MONSTAR-SCREEN-3 study [1][3] - The company emphasizes its commitment to advancing precision oncology through its comprehensive portfolio of genetic and tumor genomic testing solutions [1][3][7] MRD Studies - An oral abstract titled "Ultra-sensitive pan-cancer molecular residual disease assessment using whole-genome sequencing-based personalized ctDNA panel" will be presented, showcasing successful ctDNA detection across over 100 patients with a baseline detection rate of 100% [2] - The interim results indicate the ability to detect tumor fractions as low as 0.0001% and provide a lead time in detecting recurrence compared to imaging [2] Myriad Oncology Portfolio - Myriad Oncology will unveil a new brand identity at the ASCO meeting, highlighting its streamlined approach to germline testing, tumor profiling, and companion diagnostic testing [4] - Upcoming product innovations include the integration of Myriad's oncology portfolio with Flatiron's OncoEMR and Epic cloud-based platforms, enhancing workflow for clinicians [6] Product Innovations - The Precise MRD test, based on whole genome sequencing, is designed to monitor tumor-specific variants and is expected to launch commercially in 2026 [11] - The Prolaris Prostate Cancer Prognostic Test, utilizing AI technology, is anticipated to launch in early 2026, providing clinicians with data-driven insights for treatment decisions [11] - An expanded MyRisk Gene Panel is set to launch later this year, incorporating more clinically actionable genes based on national guidelines [11]

Core Insights - Myriad Genetics, Inc. is a leader in molecular diagnostic testing and precision medicine, focusing on advancing health and well-being through innovative testing solutions [2] Group 1: Company Overview - Myriad Genetics develops molecular tests that assess disease risk and guide treatment decisions, significantly improving patient care and reducing healthcare costs [2] Group 2: Upcoming Events - Management plans to participate in the BofA Securities 2025 Health Care Conference on May 14, 2025, at 6:00 pm ET [3] - The company will also participate in the Goldman Sachs 46th Annual Global Healthcare Conference on June 11, 2025, at 2:00 pm ET [3]

Group 1 - Myriad Genetics (MYGN) has experienced a significant downtrend, with a stock decline of 49.5% over the past four weeks, but it is now in oversold territory, indicating a potential for a turnaround [1] - The Relative Strength Index (RSI) for MYGN is currently at 18.11, suggesting that the heavy selling pressure may be exhausting itself, which could lead to a reversal in the stock's trend [5] - Analysts have raised earnings estimates for MYGN by 11.1% over the last 30 days, indicating a strong consensus among sell-side analysts that could lead to price appreciation in the near term [7] Group 2 - MYGN holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate revisions and EPS surprises, further supporting the potential for a near-term turnaround [8]

Core Insights - A study published in JCO Precision Oncology indicates that Myriad Genetics' RiskScore tool effectively drives breast cancer screening recommendations tailored to individual patient risk levels [1][2][3] Group 1: Study Findings - The study titled "Association of Polygenic-based Breast Cancer Risk Prediction with Patient Management" highlights that polygenic risk predictors are relatively new, and there is limited data on their clinical application [2] - Results show that patients with a 20% or greater lifetime risk of breast cancer, as predicted by RiskScore or the Tyrer-Cuzick model, were significantly more likely to undergo enhanced screening [3][6] - The study reassures that patients receive appropriate breast cancer screening following RiskScore testing, indicating that clinicians are utilizing RiskScore results for risk-based screening recommendations [2][3] Group 2: MyRisk Hereditary Cancer Test - MyRisk Hereditary Cancer Test with RiskScore evaluates 48 genes linked to hereditary cancer risk, providing a personalized five-year and lifetime breast cancer risk assessment for patients of all ancestries [4] - The integration of family history and clinical factors, such as breast density, enhances the risk assessment process [4] Group 3: Company Overview - Myriad Genetics is a leader in molecular diagnostic testing and precision medicine, focusing on advancing health and well-being through molecular tests that assess disease risk and guide treatment decisions [5] - The company aims to improve patient care and reduce healthcare costs by leveraging molecular insights across various medical specialties [5]

Core Viewpoint - Myriad Genetics, Inc. reported a narrower adjusted loss in Q1 2025 compared to the previous year, but total revenues fell short of expectations and decreased year-over-year, leading to a significant drop in share price after the announcement [1][3][10]. Financial Performance - The adjusted loss per share was 3 cents, which was 40% better than the Zacks Consensus Estimate, while the GAAP EPS remained flat compared to a loss of 29 cents in the prior year [1][2]. - Total revenues decreased by 3.1% year-over-year to $195.9 million, missing the Zacks Consensus Estimate by 2% [3]. - Testing volumes increased by 1% year-over-year [3]. Revenue Breakdown - Hereditary Cancer testing revenues fell by 2% year-over-year to $86.3 million [4]. - Pharmacogenomics testing revenues decreased by 20% year-over-year to $31 million [4]. - Tumor Profiling testing revenues declined by 5% year-over-year to $29.3 million [4]. - Prenatal testing revenues increased by 11% year-over-year to $49.3 million [4]. Margin and Expense Analysis - Gross margin improved by 45 basis points to 68.5%, despite a 4.5% decrease in the cost of revenues [5]. - Research and development expenses rose by 10.4% year-over-year to $27.5 million, while SG&A expenses slightly decreased by 0.3% to $69 million [5]. - The adjusted operating loss was $29 million, compared to a loss of $27.9 million in the previous year [5]. Financial Position - At the end of Q1 2025, cash and cash equivalents were $91.8 million, down from $102.4 million at the end of Q4 2024 [6]. - Long-term debt increased to $59.3 million from $39.6 million at the end of Q4 2024 [6]. - Cumulative net cash outflow from operating activities was $16.3 million, an improvement from $18.6 million in the prior year [6]. Guidance and Outlook - The company revised its 2025 revenue guidance to a range of $807-$823 million, down from the previous estimate of $840-$860 million, reflecting challenges in the pharmacogenomics and hereditary cancer testing segments [7]. - Adjusted EPS guidance was also lowered to a loss of 2 cents to earnings of 2 cents, compared to the previous range of 7-11 cents [8]. Business Developments - The decline in GeneSight revenues was attributed to changes in UnitedHealthcare's coverage policy and a reallocation of marketing spend [10]. - The hereditary business faced challenges due to slower-than-expected electronic medical record integrations [10]. - Positive developments included growth in Prenatal testing and the upcoming commercial launch of an AI-driven prostate cancer test in partnership with PATHOMIQ by the end of 2025 [11].

Revenue Performance - Total revenue for the three months ended March 31, 2025, was $195.9 million, a decrease of $6.3 million (3.1%) compared to $202.2 million in the same period of 2024[90]. - Hereditary Cancer revenue decreased by $1.8 million (2.0%) to $86.3 million, while Prenatal revenue increased by $5.0 million (11.3%) to $49.3 million[90][94]. - Pharmacogenomics revenue fell by $7.9 million (20.3%) to $31.0 million, primarily due to a 22% decrease in average revenue per test[91]. Cost and Expenses - Cost of revenue decreased by $2.9 million (4.5%) to $61.7 million, with cost of revenue as a percentage of total revenue slightly improving to 31.5%[95]. - Research and development expenses increased by $2.6 million (10.4%) to $27.5 million, reflecting the company's commitment to innovation[96]. - Total operating expenses were $163.2 million, a decrease of $2.3 million (1.4%) compared to $165.5 million in the prior year[96]. Other Income and Tax - Other income (expense), net decreased by $2.4 million (120.0%) to $(0.4) million, primarily due to a prior period gain from the Precise Tumor acquisition[97]. - Income tax benefit for Q1 2025 was $29.3 million, with an effective tax rate of 99.7%, compared to an expense of $0.1 million and a rate of (0.4)% in Q1 2024[99]. - The effective tax rate for Q1 2025 was influenced by the release of unrecognized tax benefits related to tax refund claims[99]. Cash Flow and Financing - Cash and cash equivalents decreased by $10.6 million from $102.4 million as of December 31, 2024, to $91.8 million as of March 31, 2025, primarily due to $16.3 million used in operations[109]. - Cash flows used in operating activities improved by $2.3 million in Q1 2025, totaling $(16.3) million compared to $(18.6) million in Q1 2024[110]. - Cash flows from financing activities increased by $22.4 million in Q1 2025, primarily due to $19.5 million in incremental borrowings from the ABL Facility[113]. - As of March 31, 2025, the company had $60.0 million outstanding under the ABL Facility, with $41.9 million available for borrowing[105]. - The company expects to receive a tax refund of approximately $13 million during 2025, including interest, following the review of tax refund claims related to the CARES Act[103]. - The company experienced a decrease in cash flows from investing activities, which increased by $1.2 million to $(8.3) million in Q1 2025, primarily due to higher expenditures for internal-use software[112]. Leadership and Strategy - New leadership appointments include Samraat Raha as President and CEO, effective April 30, 2025[92]. - The company plans to continue investing in clinical evidence development to support existing products and the launch of new products like FirstGene and Precise Liquid[86]. - The company aims to enhance customer experience and expand sales channels, particularly into large health systems[86]. Risk Factors - The company is subject to covenants under the ABL Facility that may limit its ability to incur additional indebtedness[106]. - Approximately 7% of the company's revenue for Q1 2025 was denominated in currencies other than the U.S. dollar, primarily Japanese yen, exposing it to foreign currency exchange risks[117].

Core Insights - Myriad Genetics reported $195.9 million in revenue for the quarter ended March 2025, reflecting a year-over-year decline of 3.1% and an EPS of -$0.03 compared to -$0.01 a year ago [1] - The revenue fell short of the Zacks Consensus Estimate of $199.96 million by 2.03%, while the EPS exceeded the consensus estimate of -$0.05 by 40% [1] Revenue Performance by Product - Prenatal revenue reached $49.30 million, surpassing the estimated $44.69 million, marking a year-over-year increase of 59.6% [4] - Hereditary Cancer revenue was $86.30 million, below the average estimate of $92.46 million, representing a year-over-year decline of 2% [4] - Pharmacogenomics revenue totaled $31 million, slightly below the estimated $32.46 million, with a year-over-year decrease of 20.3% [4] - Tumor Profiling revenue was $29.30 million, compared to the average estimate of $30.66 million, indicating a year-over-year decline of 5.2% [4] Stock Performance - Myriad's shares have returned -4.6% over the past month, contrasting with the Zacks S&P 500 composite's increase of 11.5% [3] - The stock currently holds a Zacks Rank 2 (Buy), suggesting potential outperformance against the broader market in the near term [3]

Group 1 - Myriad Genetics reported a quarterly loss of $0.03 per share, better than the Zacks Consensus Estimate of a loss of $0.05, and compared to a loss of $0.01 per share a year ago, indicating a 40% earnings surprise [1] - The company posted revenues of $195.9 million for the quarter ended March 2025, missing the Zacks Consensus Estimate by 2.03%, and down from $202.2 million year-over-year [2] - Myriad shares have declined approximately 43.8% since the beginning of the year, contrasting with the S&P 500's decline of 3.9% [3] Group 2 - The earnings outlook for Myriad is crucial for investors, as it includes current consensus earnings expectations for upcoming quarters and any recent changes to these expectations [4] - The trend for estimate revisions for Myriad is currently favorable, resulting in a Zacks Rank 2 (Buy) for the stock, suggesting it is expected to outperform the market in the near future [6] - The current consensus EPS estimate for the upcoming quarter is $0.02 on revenues of $210.73 million, and for the current fiscal year, it is $0.09 on revenues of $845.32 million [7] Group 3 - The Medical - Biomedical and Genetics industry, to which Myriad belongs, is currently in the top 31% of over 250 Zacks industries, indicating a favorable outlook for stocks in this sector [8] - Wave Life Sciences, another company in the same industry, is expected to report a quarterly loss of $0.27 per share, reflecting a year-over-year change of -12.5%, with revenues anticipated to be $13.97 million, up 11.4% from the previous year [9][10]

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]