Core Insights - Guardant Health's stock experienced a significant increase following a strong earnings report, showcasing a 40% volume growth in its oncology division [1][3] Financial Performance - The company reported total sales of $265.2 million, surpassing analyst expectations of $235.6 million, reflecting a 39% year-over-year growth [8] - Oncology sales rose by 31% to $184.4 million, exceeding the forecast of $174 million [5] - The company reported a loss of 74 cents per share, which was better than the anticipated loss of 79 cents [8] Product Performance - The volume of oncology tests shipped increased by 40% in the third quarter, following 30% growth in the second quarter and 25% in the first quarter [2][9] - Sales from the Shield blood test for colon cancer screening surged to $24 million from $1 million in the same quarter last year, significantly exceeding forecasts [6] Future Outlook - Guardant Health raised its full-year sales guidance to between $965 million and $970 million, an increase of $47.5 million from previous estimates, indicating a projected growth of 24% to 25% [12] - The company anticipates 25% growth in oncology sales and 30% growth in test volumes for the upcoming year [13]

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Core Insights - Guardant Health Inc. shares increased over 25% to $90 in premarket trading following strong financial results for Q3 2025 and an upward revision of its full-year outlook [1][3][4] Financial Performance - For Q3 2025, revenue reached $265.2 million, marking a 39% increase from $191.5 million in Q3 2024, primarily due to a 40% year-over-year growth in Oncology test volume [3] - The non-GAAP net loss for Q3 2025 narrowed to $48.3 million or $0.39 per share, compared to a loss of $55.0 million or $0.45 per share in the same quarter last year [3] Future Outlook - The company now anticipates full-year 2025 revenue between $965 million and $970 million, an increase from the previous guidance of $915 million to $925 million [4] Product Offerings - Guardant Health provides several tests including the Guardant360 Liquid test, Guardant360 CDx test, Guardant Reveal blood test, and Guardant360 Response blood test, which are designed for various cancer diagnostics and monitoring [2] - The company also introduced Shield, a blood-based screening test for colorectal cancer, which is now available through a collaboration with Quest Diagnostics [5] Stock Performance - Over the past year, Guardant Health's stock has fluctuated between $21.85 and $73.31, closing at $72.27, up 3.87% prior to the recent surge [6]

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Core Insights - Guardant Health reported a revenue of $265.2 million for the quarter ended September 2025, reflecting a year-over-year increase of 38.5% [1] - The earnings per share (EPS) was -$0.39, an improvement from -$0.45 in the same quarter last year, with an EPS surprise of +18.75% compared to the consensus estimate of -$0.48 [1] - The revenue exceeded the Zacks Consensus Estimate of $234.58 million by 13.05% [1] Financial Performance Metrics - Total oncology tests performed reached 74,000, surpassing the average estimate of 66,824 by three analysts [4] - Revenue from oncology was $184.4 million, exceeding the average estimate of $164.62 million from four analysts [4] - Revenue from biopharma and data was $54.73 million, compared to the average estimate of $48.38 million [4] - Revenue from screening was $24.11 million, significantly higher than the estimated $16.31 million [4] - Revenue from licensing and other sources was $1.95 million, slightly below the average estimate of $2.35 million [4] Stock Performance - Guardant Health's shares have returned +11.4% over the past month, outperforming the Zacks S&P 500 composite's +3.8% change [3] - The stock currently holds a Zacks Rank 3 (Hold), indicating potential performance in line with the broader market in the near term [3]

Core Insights - Guardant Health reported a quarterly loss of $0.39 per share, better than the Zacks Consensus Estimate of a loss of $0.48, and improved from a loss of $0.45 per share a year ago, resulting in an earnings surprise of +18.75% [1] - The company achieved revenues of $265.2 million for the quarter ended September 2025, exceeding the Zacks Consensus Estimate by 13.05% and showing a significant increase from $191.48 million in the same quarter last year [2] - Guardant Health's stock has increased by approximately 127.8% since the beginning of the year, outperforming the S&P 500's gain of 17.2% [3] Financial Performance - Over the last four quarters, Guardant Health has surpassed consensus EPS estimates three times and topped consensus revenue estimates four times [2] - The current consensus EPS estimate for the upcoming quarter is -$0.46 on revenues of $251.41 million, and for the current fiscal year, it is -$1.84 on revenues of $921.37 million [7] Industry Context - The Medical - Biomedical and Genetics industry, to which Guardant Health belongs, is currently ranked in the top 37% of over 250 Zacks industries, indicating a favorable outlook compared to the bottom 50% [8] - Empirical research suggests a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can be tracked by investors [5]

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 surpassed $1 billion [6][25] - Non-GAAP gross margin improved to 66% in Q3 2025, up from 63% in the prior year, driven by reduced costs [29] - Adjusted EBITDA loss was $45.5 million, an improvement from a loss of $56.2 million in Q3 2024 [30] 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 in volume [8][25] - Screening revenue from Shield totaled $24.1 million, generated from 24,000 tests, with an average selling price (ASP) of approximately $880 [28] - Biopharma and data revenue grew 18% year-over-year to $54.7 million, supported by two companion diagnostic approvals [27] Market Data and Key Metrics Changes - The screening business is tracking at an annual run rate of approximately $100 million, one year into the commercial launch of the FDA-approved product [6] - Shield tests have shown high adherence rates, with over 90% of ordered cases resulting in completed blood samples [18] Company Strategy and Development Direction - The company aims to expand its commercial infrastructure for Shield, leveraging partnerships with Quest Diagnostics and Path Group to enhance access [19][20] - Continued investment in commercial initiatives and the introduction of new smart applications are expected to drive future growth [14][15] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential inclusion of Shield in American Cancer Society guidelines, which could enhance commercial coverage [40][41] - The company raised its full-year 2025 revenue guidance to $965-$970 million, reflecting stronger-than-expected performance [31][32] Other Important Information - The company surpassed 1 million cumulative clinical patients tested, highlighting the impact of its tests in clinical practice [7] - The submission of the PMA application to the FDA for Guardant360 Liquid is expected to streamline the product offering and enhance market adoption [11] 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 $1,495, with expectations for continued strong payment from Medicare Advantage [36][37] Question: Is guideline inclusion by the American Cancer Society a real possibility by year-end? - Management remains optimistic about the potential inclusion and its positive impact on reimbursement rates, although it will take time to translate into payments [40][41] Question: How should we think about 2026 growth for Shield? - Management is confident about long-term growth but refrained from providing specific guidance for 2026 at this time [45][46] Question: Can you provide any KPIs around average testing frequency per physician? - Management reported high adherence rates, with over 90% of ordered Shield tests being completed [80]

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]

Revenue Performance - Revenue for the three months ended September 30, 2025, was $265,196,000, representing a 38.5% increase from $191,476,000 in the same period of 2024[15] - Total revenue for the three months ended September 30, 2025, was $265.2 million, a 38.5% increase from $191.5 million in the same period of 2024[157] - Revenue from the United States was $249.4 million, representing a 38.4% increase compared to $180.1 million in the same period last year[158] - International revenue increased to $15.8 million in Q3 2025, up 38.5% from $11.4 million in Q3 2024[158] - For the nine months ended September 30, 2025, total revenue was $700.8 million, a 30.4% increase from $537.2 million in the same period of 2024[158] Net Loss and Financial Improvement - Net loss for the three months ended September 30, 2025, was $92,725,000, compared to a net loss of $107,754,000 for the same period in 2024, indicating an improvement of 14.5%[15] - The company reported a loss from operations of $98,989,000 for the three months ended September 30, 2025, compared to a loss of $117,328,000 for the same period in 2024, showing a 15.5% improvement[15] - For the nine months ended September 30, 2025, the net loss was $287.8 million, a decrease from a net loss of $325.4 million for the same period in 2024, representing a 11.5% improvement[27] Assets and Liabilities - Total current assets decreased to $828,885,000 as of September 30, 2025, down from $1,055,114,000 as of December 31, 2024, a decline of 21.4%[13] - Total liabilities increased slightly to $1,631,259,000 as of September 30, 2025, compared to $1,625,256,000 as of December 31, 2024[13] - Total stockholders' deficit increased to $354,473,000 as of September 30, 2025, from $139,647,000 as of December 31, 2024[13] - Cash and cash equivalents increased to $580,013,000 as of September 30, 2025, from $525,540,000 as of December 31, 2024, an increase of 10.3%[13] - Total cash, cash equivalents, and restricted cash at the end of September 2025 was $689.5 million, compared to $688.4 million at the end of September 2024, showing a slight increase[27] Research and Development - Research and development expenses for the nine months ended September 30, 2025, were $265,927,000, up from $254,210,000 in the same period of 2024, reflecting a 4.3% increase[15] - Research and development expenses for the three months ended September 30, 2025, were $75.8 million, up from $68.4 million in 2024, reflecting a 6.5% increase[157] Stock-Based Compensation - The company reported stock-based compensation of $123.0 million for the nine months ended September 30, 2025, up from $104.0 million in the same period of 2024, indicating a 18.3% increase[27] - For the three months ended September 30, 2025, total stock-based compensation expense was $42.8 million, a decrease of 14% from $49.8 million in the same period of 2024[140] - Stock-based compensation recorded for performance stock units (PSUs) was $4.9 million for the three months ended September 30, 2025, down from $22.7 million in 2024[138] - Future stock-based compensation for unvested restricted stock units as of September 30, 2025, was $192.8 million, expected to be recognized over 2.0 years[135] Legal and Regulatory Matters - In October 2023, the District Court dismissed with prejudice TwinStrand's infringement claims related to certain patents[119] - The jury awarded TwinStrand Biosciences and the University of Washington $83.4 million in damages, representing a 6% royalty on past sales due to willful patent infringement[120] - The Company filed a patent infringement suit against Tempus AI, Inc., seeking an injunction and compensatory damages for alleged infringement of five patents[121] - The Company was awarded $292.5 million in a lawsuit against Natera for false advertising, including $175.5 million in punitive damages[124] Future Obligations and Commitments - The Company has future principal contractual obligations for operating lease commitments totaling $245.7 million as of September 30, 2025[115] - The weighted-average remaining lease term was 6.9 years as of September 30, 2025[115] Financial Instruments and Debt - The 2027 Notes, with a principal amount of $1.15 billion, will mature on November 15, 2027, and do not bear interest[93] - The 2031 Notes, issued in February 2025, bear interest at a rate of 1.25% per annum and will mature on February 15, 2031[100] - The Company recognized total interest expenses of $943,000 for the three months ended September 30, 2025, and $2.7 million for the nine months ended September 30, 2025[107] - The effective interest rate for the 2031 Notes was 0.4% for the three months ended September 30, 2025[107] Customer and Revenue Concentration - Revenue from significant customers, including Customer B, represented 29% of total revenue for the three months ended September 30, 2025[43] - The Company has not experienced any material losses related to accounts receivable from individual customers or groups of customers[42]

Financial Performance - Total revenue increased to $265.2 million, a 39% increase compared to $191.5 million in Q3 2024 [8, 43] - Oncology revenue grew to $184.4 million, a 31% year-over-year increase from $141.2 million in Q3 2024 [8, 10, 43] - Biopharma & Data revenue reached $54.7 million, an 18% year-over-year increase from $46.5 million in Q3 2024 [8, 28, 43] - Screening revenue was $24.1 million compared to $1.0 million in Q3 2024 [8, 43] - The company is raising revenue guidance for the full year 2025 to $965 million - $970 million, representing approximately 31% year-over-year growth [48] Oncology Business - Oncology volume grew by 40% year-over-year, driven by strong performance across all products [10, 17] - Guardant360 volume growth exceeded 30% year-over-year [17] Screening Business (Shield) - Shield revenue reached $24 million in Q3 2025 [33] - Shield volume increased to 24,000 in Q3 2025 [33] - The company expects 80,000 - 82,000 Shield volume for the full year [48] Biopharma & Data - Two new CDx approvals were obtained in Q3, bringing the total to 23 approvals for Guardant360 CDx [29, 30] Gross Margin - Non-GAAP gross margin increased to 66% in Q3 2025, up from 63% in Q3 2024 [45, 46]