Raha highlighted volume growth in several areas, including MyRisk in oncology, with affected volumes up 14% and unaffected volumes up 11% year-over-year. He also pointed to an acceleration in Prolaris test volume growth to 12% year-over-year in the quarter, which he attributed to actions taken over the past two quarters, including incremental commercial investments focused on urologists.Wheeler said overall test volumes increased 2% year-over-year, while average revenue per test declined 2% year-over-year. ...

Myriad Genetics (NasdaqGS:MYGN) Q4 2025 Earnings call February 23, 2026 04:30 PM ET Company ParticipantsAndrew Cooper - Director of Equity Research for Life Science Tools and Services and Diagnostics and Clinical LaboratoriesBen Wheeler - CFOBrian Donnelly - CCOLu Li - Director of Healthcare Equity ResearchMark Verratti - COOMatt Scalo - SVP of Investor RelationsSam Raha - President and CEOConference Call ParticipantsBill Bonello - Senior Research AnalystDan Brennan - Managing Director and Senior Research A ...

Myriad Genetics (NasdaqGS:MYGN) Q4 2025 Earnings call February 23, 2026 04:30 PM ET Speaker11Good day, and thank you for standing by. Welcome to the Myriad Genetics fourth quarter and full year 2025 earnings call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, you will need to press star one one on your telephone. You will then hear an automated message advising your hand is raised ...

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Core Insights - Brown Capital Management's Small Company Fund underperformed in Q4 2025, with a decline of 1.50% compared to the Russell 2000® Growth index's gain of 1.22% [1] - The Fund's performance for the entire year of 2025 was down 11.46%, significantly lagging behind the Index's return of 13.01% [1] - The Fund's investment strategy is focused on company fundamentals, which showed strong revenue and earnings growth in 2025 [1] Company Focus: Veracyte, Inc. - Veracyte, Inc. is highlighted as a key holding in the Fund, with a market capitalization of $2.817 billion [2] - The stock price of Veracyte, Inc. closed at $35.63 on February 20, 2026, with a one-month return of -12.18% and a 52-week loss of 9.48% [2] - Veracyte holds a dominant market position with over 50% market share in its core products, Decipher and Afirma, which contributed more than 90% of revenue in 2024 [3] - The Decipher product has a market penetration of only 40%, indicating potential for double-digit growth in the coming years, while Afirma offers stability due to higher market penetration [3] - Veracyte's product pipeline could expand its market opportunity by over $3 billion, including tests for breast cancer, prostate cancer, and lung cancer [3] - The company turned profitable in 2024 and has shown significant margin expansion, with expectations for further growth [3] - Veracyte maintains a strong balance sheet with over $400 million in cash and has been free cash flow positive since 2023 [3]

GRAIL (NasdaqGS:GRAL) Q4 2025 Earnings call February 19, 2026 05:00 PM ET Company ParticipantsAaron Freidin - CFOAlex Dobbin - Director and Investor Relations ContactAndy Partridge - Chief Commercial OfficerBob Ragusa - CEODoug Schenkel - Managing Director of Life Science Tools and DiagnosticsJosh Ofman - PresidentSir Harpal Kumar - Chief Scientific Officer and President of InternationalSubbu Nambi - Managing DirectorConference Call ParticipantsCatherine Schulte - Senior Research AnalystDan Brennan - Senior ...

Financial Data and Key Metrics Changes - Fourth quarter revenue was $43.6 million, an increase of $5.3 million, or 14%, compared to Q4 2024 [20] - Full year total revenue was $147.2 million, up 17% from 2024, with screening revenue of $138.6 million, up 28% [20][21] - Net loss for Q4 2025 was $99.2 million, a 2% increase compared to Q4 2024, while full year net loss improved by 80% to $408.4 million [22] - Non-GAAP adjusted gross profit for Q4 2025 was $23.1 million, a 29% increase compared to Q4 2024 [23] - Adjusted EBITDA for Q4 2025 was -$71.8 million, an improvement of 15% compared to Q4 2024 [24] Business Line Data and Key Metrics Changes - U.S. Galleri tests volume grew 36% to over 185,000 tests in 2025, with revenue growth of 26% [8] - Development services revenue decreased by 49% to $8.6 million in 2025 [21] Market Data and Key Metrics Changes - The prescriber base for Galleri increased by 30% to approximately 17,000 providers [8] - The company is focused on expanding awareness of multi-cancer early detection and anticipates growing conviction in Galleri among patients, providers, and employers [9] Company Strategy and Development Direction - The company plans to expand its field sales and medical team to drive commercial momentum [7] - The PMA submission to the FDA for Galleri marks a critical step in making the test available to more people [9] - The company aims to leverage strong results from clinical trials to expand partnerships and access to Galleri [28] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential for Galleri to bend the cancer mortality curve at a population scale [16] - The company reiterated guidance for Galleri sales growth of 22%-32% and cash burn for 2026 to be no more than $300 million [26] - The cash runway extends into 2030, positioning the company well for future growth [26] Other Important Information - The NHS-Galleri trial showed a fourfold increase in cancer detection rates and a significant reduction in stage 4 cancer diagnoses [5][12] - The company plans to present full data from the NHS-Galleri and PATHFINDER 2 studies in mid-2026 [27][90] Q&A Session Summary Question: Will the FDA approval decision be impacted by missing the stage shift endpoint? - Management confirmed that the FDA will focus on clinical performance and safety, and there is no obvious correlation between the NHS-Galleri study results and the FDA's view on the test [31] Question: How does the NHS-Galleri trial impact the strategy to expand Galleri internationally? - Management believes the strong data from the NHS-Galleri trial will be compelling for discussions with other countries [36] Question: What is the probability of FDA approval unchanged as a result of the NHS Galleri readout? - Management indicated that the probability remains unchanged, focusing on clinical performance and safety in their submission [45][50] Question: What are the next steps regarding the NHS and the multi-cancer early detection tests? - Management has ongoing conversations with the NHS and anticipates that they will want to see full results before engaging in meaningful discussions [62] Question: How will Medicare evaluate the NHS trial data for coverage? - Management believes they will provide a robust package of data to Medicare, including substantial stage 4 reduction and overall clinical performance [67]

Core Insights - Castle Biosciences announced the publication of a study demonstrating that its AdvanceAD-Tx test can effectively identify patients with moderate-to-severe atopic dermatitis who are more likely to respond positively to JAK inhibitor therapy compared to Th2-targeted therapies [1][2][8] Group 1: Study Findings - The AdvanceAD-Tx test identified approximately 30% of patients as having a JAK Inhibitor Responder Profile, who were 5.5 times more likely to achieve at least 90% improvement in Eczema Area and Severity Index (EASI-90) within three months compared to those on Th2-targeted therapies (45.5% vs. 8.3%, p=0.021) [3][6] - Patients with the JAK Inhibitor Responder Profile achieved a response nearly four times faster than those treated with Th2-targeted therapies (p=0.049) [3][6] - The study also indicated that patients with a JAK Inhibitor Responder Profile reported higher rates of "no itch" (45.5% vs. 8.3%, p=0.021) and remained flare-free by three months (54.5% vs. 16.7%, p=0.041) [6][8] Group 2: Clinical Implications - The findings suggest that aligning systemic therapy selection with an individual patient's molecular profile can streamline care, reduce unnecessary treatment changes, and accelerate meaningful clinical improvement [5][8] - The AdvanceAD-Tx test provides objective molecular insights that can help clinicians make more confident, evidence-based treatment decisions earlier in the patient journey [5][8] - Patients identified with a Th2 Molecular Profile showed no statistically significant differences in outcomes when treated with either JAK inhibitors or Th2-targeted therapies, emphasizing the importance of personalized treatment decisions [4][8] Group 3: Product Overview - AdvanceAD-Tx is a non-invasive gene expression profile test designed for patients aged 12 years and older with moderate-to-severe atopic dermatitis, evaluating 487 genes across 12 inflammatory and cutaneous biology pathways [2][6] - The test requires only lesional skin scrapings, eliminating the need for biopsies, and classifies patients into either a JAK Inhibitor Responder Profile or a Th2 Molecular Profile [2][7]

Financial Data and Key Metrics Changes - Total revenue for Q4 2025 was $281 million, representing a 39% year-over-year growth, while full-year revenue reached $982 million, a 33% increase year-over-year [9][31] - Non-GAAP gross margin improved to 66% in Q4 2025, up from 63% in the prior year, driven by a significant reduction in Reveal cost per test [32][33] - Adjusted EBITDA loss improved to $64.9 million in Q4 compared to $78.4 million in the prior year quarter [34] Business Line Data and Key Metrics Changes - Oncology revenue increased 30% to $190 million in Q4, with volumes growing 38% to approximately 79,000 tests [9][29] - Screening revenue totaled $35 million from approximately 38,000 Shield tests in Q4, reflecting strong sequential growth [19][30] - Biopharma and data revenue grew 18% year-over-year to $210 million in 2025 [16][17] Market Data and Key Metrics Changes - Guardant360 Liquid volumes increased nearly 30%, supported by expanding clinical utility from Smart apps launched over the past year [30] - Reveal continued to be the fastest-growing oncology product, benefiting from CRC surveillance reimbursement and early uptake for late-stage therapy response monitoring [12][30] - Shield's adherence rate reached 93% across the first 100,000 tests ordered, significantly higher than other screening modalities [22] Company Strategy and Development Direction - The company aims to expand Shield to include multi-cancer detection results, enhancing its market position [24] - Strategic collaborations with Quest Diagnostics and PathGroup are expected to broaden national reach and enhance commercial infrastructure [23] - The acquisition of MetaSyte Diagnostics is anticipated to enhance the oncology product portfolio and accelerate multi-disease detection capabilities [28] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about 2026, expecting revenue growth of 27%-30% and oncology revenue growth of 25%-27% [36][37] - The company is focused on achieving cash flow breakeven by the end of 2027, with expectations of positive free cash flow from the core business in 2026 [35][40] - Management highlighted the importance of reimbursement wins for therapy monitoring as a significant growth driver for the oncology business [46] Other Important Information - The company reported a significant increase in the commercial team, with approximately 300 sales representatives by the end of 2025 [21] - The ADLT reimbursement rate for Shield is set at $1,495, secured through December 2027, supporting healthy ASP and gross profit [25][39] - The company is actively pursuing FDA approvals for new products, including Guardant360 Liquid CDx for lung cancer [40] Q&A Session Summary Question: Can you elaborate on Reveal therapeutic monitoring and its opportunity? - Management expressed excitement about Reveal for therapy monitoring, emphasizing its synergy with Guardant360 for patient treatment decisions [44][46] Question: How should we think about oncology growth throughout the year? - Management is bullish about 2026, expecting at least 20% growth in Guardant360 volumes and strong performance from Reveal [50][51] Question: What is the expected burn for Shield in 2026? - The company anticipates a similar burn for screening as in 2025, around $220 million, while the rest of the business is expected to be cash flow positive [54][55] Question: What is the latest thinking on ADLT pricing for Guardant360? - Management indicated that no ADLT pricing is baked into the 2026 guidance, with expectations for FDA submission in H2 2026 [59][61] Question: Can you discuss the opt-in rate for MCED Shield and its potential for FDA approval? - Management reported good adoption rates for the MCED offering, with enthusiasm from providers and patients, but did not provide specific numbers [76][78]

Financial Data and Key Metrics Changes - Total revenue for Q4 2025 was $281.3 million, representing a 39% year-over-year growth, while full-year revenue reached $982.0 million, a 33% increase year-over-year [7][28]. - Non-GAAP gross margin improved to 66% in Q4 2025, up from 63% in the prior year, and for the full year, it increased from 62% in 2024 to 66% [29][30]. - Adjusted EBITDA loss improved to $64.9 million in Q4 compared to $78.4 million in the prior year, and for the full year, the loss was $220.9 million versus $257.5 million in 2024 [31]. Business Line Data and Key Metrics Changes - Oncology revenue increased by 30% to $189.9 million in Q4, with approximately 79,000 tests conducted, reflecting a 38% volume growth [25][28]. - Screening revenue totaled $35.1 million from approximately 38,000 Shield tests in Q4, with an average selling price (ASP) of approximately $850 [27][30]. - Biopharma and data revenue grew 9% to $54.0 million, aligning with expectations [27]. Market Data and Key Metrics Changes - The company received Medicare coverage for colorectal cancer (CRC) surveillance in early 2025, which has positively impacted the adoption of Reveal [5]. - The Shield test has shown strong adherence rates of 93% among patients, significantly higher than traditional screening methods [18]. Company Strategy and Development Direction - The company aims to expand its multi-cancer detection capabilities through the Shield platform, which includes a new multi-cancer detection results report [21]. - Strategic partnerships with Quest Diagnostics and PathGroup are expected to enhance national reach and operational capabilities in 2026 [19][20]. - The acquisition of MetaCyte Diagnostics is anticipated to enhance the company's R&D capabilities and accelerate its multi-disease detection pipeline [32]. Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about continued strong growth in oncology, projecting a 25%-27% growth rate for oncology revenue in 2026, supported by volume growth of approximately 30% [33]. - The company expects to achieve free cash flow positivity for the core business in 2026, excluding screening, and aims for company-wide cash flow breakeven by the end of 2027 [32][36]. - Management highlighted the importance of reimbursement wins for therapy monitoring as a significant growth driver for the oncology business [42]. Other Important Information - The company has established a robust pipeline of ongoing companion diagnostics (CDx) programs, with 25 approvals to date across various regions [14]. - The company is focused on improving gross margins through ASP optimization and operational efficiencies, with expectations of non-GAAP gross margins in the range of 64%-65% for 2026 [36]. Q&A Session Summary Question: Can you elaborate on Reveal therapeutic monitoring and its opportunity? - Management expressed excitement about Reveal for therapy monitoring, emphasizing its synergy with Guardant360 for patient monitoring and therapeutic decisions [40][42]. Question: How should we think about oncology growth throughout the year? - Management is bullish about 2026, expecting at least 20% growth in Guardant360 volumes and strong performance from Reveal, which is anticipated to remain the fastest-growing product [46][48]. Question: What is the expected burn for Shield in 2026? - The company anticipates a similar burn level for screening as in 2025, around $220 million, while the rest of the business is expected to be free cash flow positive [50][52]. Question: What is the latest on ADLT pricing for Guardant360? - Management indicated that no ADLT pricing is baked into the 2026 guidance, with expectations for FDA submission progress in the second half of the year [58][59]. Question: Can you discuss the opt-in rate for MCED Shield and potential FDA submissions? - Management noted good adoption rates for the MCED offering, with enthusiasm from providers and patients, but did not provide specific numbers [76][78].