Summary of Guardant Health FY Conference Call Company Overview - **Company**: Guardant Health (NasdaqGS:GH) - **Industry**: Life Sciences, Tools, and Diagnostics Key Financial Targets - **Revenue Target**: $2.2 billion by 2028, with a potential aspiration of $5 billion [2][4] - **Oncology Revenue**: Expected to be $1.4 billion by 2028, accounting for over 60% of total revenue [4][6] - **Biopharma Revenue**: Forecasted to grow from $200 million to $300 million by 2028 [5] - **Screening Revenue**: Projected to reach $500 million by 2028, representing approximately 25% of total revenue [6] Product Performance and Growth - **Guardant360**: Continues to grow at approximately 30% year-over-year, driven by increased orders per oncologist and new SMART apps [7][10] - **Reveal**: Fastest-growing oncology product, with potential for new indications and therapy monitoring applications [5][12] - **Shield**: Expected to contribute significantly to revenue, with a target of $500 million by 2028 [6] Market Dynamics - **Oncology Market**: Guardant360 has penetrated the oncology market well, with over 10,000 oncologists ordering the test annually [7] - **Liquid Biopsy**: The company believes that centralized lab business will remain dominant due to the complexity of services offered compared to hospital labs [24] Regulatory and Reimbursement Strategies - **ADLT Submission for Reveal**: Ongoing process with potential upside if approved, targeting an ASP of $1,000 by 2028 [14][16] - **Medicare Reimbursement**: Critical for achieving ASP targets and driving revenue growth [16] Operational Efficiency and Cost Management - **Cost of Goods Sold (COGS)**: Targeting $200 per test for Shield, with current costs below $500 [17][29] - **Gross Margin Targets**: Expecting gross margins of 65-70% across the product portfolio by 2028 [29][30] Sales and Marketing Strategy - **Sales Force Expansion**: Currently over 250 sales representatives, with plans for continued ramp-up [35] - **Partnership with Quest**: Aims to leverage Quest's extensive network to enhance market penetration [35] Future Outlook and Strategic Initiatives - **Breakeven Target**: Committed to achieving breakeven by the end of 2027, with no changes to the plan despite recent funding [26][27] - **M&A Opportunities**: Focused on acquiring technologies that enhance product offerings, with a preference for smaller deals [39][40] Clinical Trials and Product Development - **SERENA-6 Protocol**: Anticipated to be a significant catalyst for product adoption and market expansion [37][38] Conclusion - Guardant Health is positioned for strong growth in the oncology diagnostics market, with a clear strategy for revenue generation, operational efficiency, and market expansion through innovative products and strategic partnerships. The company remains focused on achieving its financial targets while navigating regulatory landscapes and enhancing its product offerings.

Core Insights - Guardant Health's shares surged by 28% following the announcement of impressive growth metrics across its product lines [1] Financial Performance - Third-quarter revenue increased by 39% year-over-year to $265.2 million, with significant contributions from various segments [3] - Revenue from the biopharma division rose by 18% to $54.7 million, while oncology segment sales jumped 31% to $184.4 million, driven by a 40% increase in oncology tests to 74,000 [3] - The screening business revenue grew 24-fold to $24.1 million, with Shield screening tests reaching 24,000 [3] - Adjusted net loss narrowed to $48.3 million from $55 million in Q3 2024 [4] Product Offerings - The Guardant360 liquid biopsy test aids in identifying treatment options for cancer patients, focusing on solid tumors in various organs [4] - The Shield blood test provides a simpler method for early colon cancer screening compared to traditional methods [5] Strategic Partnerships - Collaborations with major clinical laboratories like Quest Diagnostics and organizations such as the American Cancer Society are enhancing growth prospects [5] Future Outlook - Management has raised the full-year sales forecast, projecting a revenue increase of 31% to between $965 million and $970 million in 2025 [6] - The rapid expansion of Guardant's oncology and screening businesses is expected to continue, supported by new partnerships [8]

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]

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]

Financial Performance and Growth - Guardant Health expects total revenue to reach approximately $920 million in 2025, representing a 24%-25% year-over-year growth rate[28, 341, 343] - The company projects a total revenue target of approximately $2.2 billion by 2028, indicating a compound annual growth rate (CAGR) of around 34% from 2025 to 2028[346, 366, 368] - Guardant Health anticipates screening revenue to exceed $500 million by 2028[299, 363] - The company aims to achieve free cash flow breakeven by the fourth quarter of 2027[381, 383] Product Development and Innovation - Guardant Health has launched multiple Smart Apps on Guardant360, enhancing its capabilities for therapy selection[30, 163] - The company has completed the transition to the Smart Platform across its portfolio, improving liquid biopsy capabilities[32] - Guardant Health is expanding Shield to include multi-cancer detection, with broad availability expected in October[21, 307] - Reveal, Guardant Health's tissue-free MRD solution, has achieved a greater than 50% reduction in COGS and is targeting an ASP of $1,000 by 2028[32, 185] - Guardant Health is launching Reveal for therapy monitoring in Q4 2025 and plans to increase Reveal clinical data generation by 10x in 2026[200, 390] Market Position and Commercial Strategy - Guardant Health's Shield has demonstrated 99% specificity in real-world studies with over one year of clinical follow-up, and a 41% positive predictive value (PPV) for any solid tumor[119, 127] - The company has established a strategic collaboration with Quest Diagnostics to expand access to Shield, leveraging Quest's national sales team and patient access points[300, 301] - Guardant Health has secured Medicare reimbursement for CRC surveillance, with a reimbursement rate of $1,644 per test[185]

Summary of Guardant Health (GH) FY Conference Call - August 13, 2025 Company Overview - **Company**: Guardant Health - **Industry**: Oncology diagnostics, specializing in liquid and tissue-based testing for cancer screening, therapy selection, and minimal residual disease (MRD) monitoring [2][3] Key Financial Highlights - **Clinical Volumes**: 30% year-over-year growth in oncology clinical volumes [3] - **Overall Revenue**: 31% year-over-year increase in total revenue [3] - **Average Selling Price (ASP)**: Tissue ASP increased from approximately $1,700 to $2,000, three years ahead of schedule [4][5] - **Gross Margin for Shield**: Achieved a gross margin of 48% in Q2, with a target cost per test of around $200 to potentially increase margins above 60% [15][17] Product Performance - **Tissue Testing**: Introduction of RNA features in tissue tests, contributing to ASP improvements and reimbursement from Medicare [6][7] - **Shield Product**: Expected to generate over $50 million in revenue with approximately 70,000 tests for the year; strong market pull and adoption exceeding internal expectations [11][12] - **Cost Reduction**: Significant reduction in cost per test for Shield from over $1,000 to below $500, with ongoing efforts to further decrease costs [14][15] Market Dynamics - **Colorectal Cancer (CRC) Screening**: Approximately 50 million people in the U.S. are unscreened; Guardant Health aims to convert a significant portion of this population through convenient blood tests [37][38] - **Market Share Potential**: The blood-based CRC screening market is substantial, with a doubling of screening rates observed when Shield tests are included in screening options [38][39] Future Developments - **Expansion Plans**: Plans to hire 250 sales representatives for Shield, increasing from a previous target of 200, with a long-term goal of 600-700 reps [19][20] - **Multi-Cancer Detection**: Shield is expected to evolve into a multi-cancer detection test, expanding beyond CRC to at least 10 different cancer types [24][36] - **Investor Day**: Upcoming Investor Day in late September 2025, anticipated to reveal new financial targets and updates on product performance [57][62] Competitive Landscape - **Market Position**: Guardant Health is positioned as a leader in the liquid biopsy market, with competitors showing lower sensitivity in their tests compared to Shield [34][35] - **Regulatory Engagement**: Positive discussions with ACS stakeholders regarding guideline inclusion for Shield, expected by the end of the year [40][46] Additional Insights - **AI Integration**: Guardant Health is leveraging AI in its applications, with a large dataset to enhance diagnostic capabilities [55][56] - **MRD Business Growth**: The Reveal MRD test is experiencing rapid growth, with significant demand in breast cancer monitoring [47][50] This summary encapsulates the key points discussed during the conference call, highlighting Guardant Health's strong performance, market opportunities, and future growth strategies.

Core Insights - Guardant Health reported Q2 2025 GAAP revenue of $232.1 million, surpassing analyst expectations of $211.5 million, and a Non-GAAP loss per share of ($0.44), better than the anticipated loss of ($0.73) per share, indicating strong growth momentum [1][2] Financial Performance - Revenue growth accelerated to 31% year over year, driven by increased customer adoption and higher reimbursement rates [5] - Non-GAAP gross margin improved to 66%, up from 60% a year earlier, reflecting better reimbursement and cost reductions [10] - Free cash flow improved to negative $65.9 million from negative $99.1 million in Q2 2024, attributed to timing differences in bonus payouts [11] Business Overview - Guardant Health specializes in blood- and tissue-based cancer tests for therapy selection, disease monitoring, and early screening, with flagship products including Guardant360, Guardant Reveal, and Shield [3] - The company focuses on innovation in oncology diagnostics, regulatory approvals, strategic partnerships, geographic expansion, and improving reimbursement landscapes [4] Segment Performance - Oncology segment revenue rose 22% to $158.7 million, with test volumes increasing by 30% year over year to nearly 64,000 [5] - Shield, the blood-based screening test for colorectal cancer, generated $14.8 million in revenue, with test volumes growing by 78% from the previous quarter [6] - The biopharma and data segment revenue reached $56.0 million, up 28% year over year, benefiting from increased research collaborations [7] Strategic Developments - Eleven new Smart Liquid Biopsy applications for Guardant360 were launched, enhancing clinical utility [8] - Shield received FDA Breakthrough Device Designation and was included in updated U.S. guidelines, supporting broader adoption [14] Outlook - Full-year 2025 revenue guidance was raised to $915–$925 million, reflecting strong momentum, with projected revenue growth of 24–25% year over year [15] - Gross margin targets increased to 63–64% for non-GAAP margin, with operating expenses expected to rise to $840–$850 million [16] - Free cash flow burn is projected at $225–$235 million, with expectations for the core business to reach free cash flow breakeven by Q4 2025 [16]

Financial Data and Key Metrics Changes - Q2 revenue grew 31% year over year to $232,100,000, driven by strong performance across oncology, biopharma, and screening businesses [8][28] - Non-GAAP gross profit increased by $47,000,000 or 44% year over year, with a non-GAAP gross margin of 66%, up from 60% in 2024 [35] - Adjusted EBITDA loss improved to $51,900,000 for Q2 2025, compared to a loss of $61,900,000 in Q2 2024 [37] Business Line Data and Key Metrics Changes - Oncology revenue increased 22% to $158,700,000, with volumes growing 30% year over year to approximately 64,000 tests [29][30] - Biopharma revenue reached a record $56,000,000, growing 28% year over year [32] - Shield testing revenue totaled $15,000,000 in Q2, driven by approximately 16,000 tests [20][33] Market Data and Key Metrics Changes - Guardant360 Liquid saw over 20% year-over-year volume growth for the fourth consecutive quarter [30] - Guardant360 tissue achieved an average selling price (ASP) of approximately $2,000, reaching the 2028 target three years ahead of schedule [31] - Shield ASP increased to over $900 in Q2, up from approximately $600 in Q1 [34][54] Company Strategy and Development Direction - The company is focused on expanding its commercial infrastructure, expecting to surpass 250 sales reps by year-end to support growth [21] - Shield is positioned as a multi-cancer detection platform, with ongoing efforts to broaden its impact across various cancer types [25][26] - The company aims to achieve cash flow breakeven by 2028, with a commitment to reducing cash burn each year [41][92] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the oncology business's durable growth, supported by CGP penetration and favorable ASP dynamics [18] - The company raised its full-year 2025 revenue guidance to $915,000,000 to $925,000,000, representing growth of approximately 24% to 25% compared to 2024 [39] - Management remains optimistic about the potential for Shield and its inclusion in national screening guidelines [23][81] Other Important Information - The company is actively working on the Shield V2 program, with ongoing developments and no specific timeline committed for data release [52][86] - The National Comprehensive Cancer Network (NCCN) updated its CRC screening guidelines to include Shield, enhancing its market position [23][24] Q&A Session Summary Question: Did you see any benefit from the New England Journal publication in Q2? - Management noted that the impact from the publication was minimal, with most growth attributed to product market fit and ongoing demand [46] Question: What is driving Shield's impressive growth? - Management highlighted strong demand from physicians, increased sales rep productivity, and the recent NCCN guideline update as key drivers [51][52] Question: Can you provide insights on the growth of Guardant360? - Management indicated broad-based growth, with increased utilization and significant share gains in the market [59][60] Question: What are the next steps for Shield to be marketed as an MSEAD test? - Management confirmed that Shield is operationally ready for patient testing and is not waiting for additional pivotal study readouts [66][67] Question: How confident is management about Reveal Medicare reimbursement? - Management expressed high confidence based on previous experiences and the speed of past approvals [78][80] Question: What is the timeline for Shield V2 data? - Management stated that the program is active, with ongoing work, but no specific timeline for data release was provided [86]

Financial Data and Key Metrics Changes - In Q2 2025, total revenue grew 31% year over year to $232.1 million, driven by strong performance across oncology, biopharma, and screening business lines [6][27][30] - Non-GAAP gross profit increased by $47 million or 44% year over year, with a non-GAAP gross margin of 66%, up from 60% in 2024 [34] - Adjusted EBITDA loss improved to $51.9 million, a $10 million improvement compared to Q2 2024 [36] Business Line Data and Key Metrics Changes - Oncology revenue increased 22% to $158.7 million, with volumes growing 30% year over year to approximately 64,000 tests [28][29] - Biopharma revenue reached a record $56 million, growing 28% year over year [30] - Screening revenue from Shield totaled $14.8 million, driven by approximately 16,000 tests [31] Market Data and Key Metrics Changes - Guardant360 Liquid ASP was in the range of $3,000 to $3,100, while Guardant360 Tissue ASP reached approximately $2,000, achieving the 2028 target three years ahead of schedule [29] - Shield ASP increased to over $900 in Q2, up from approximately $600 in Q1, driven by improved Medicare reimbursement rates [32][52] Company Strategy and Development Direction - The company is focused on expanding its oncology business through product innovation and commercial execution, particularly with Guardant360 Liquid and REVEAL [4][17] - Shield is positioned as a multi-cancer detection platform, with ongoing efforts to broaden its impact across various cancer types [24][25] - The company plans to reinvest incremental gross profit from Shield back into sales and marketing to accelerate commercial infrastructure [33][91] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving cash flow breakeven by 2028, with a commitment to reducing cash burn each year [39][90] - The company raised its full-year 2025 revenue guidance to a range of $915 million to $925 million, reflecting stronger than expected performance [37] - Management highlighted the positive reception of new product features and the potential for significant growth in the liquid biopsy market [45][59] Other Important Information - The company is actively working on the Shield V2 program, with expectations for data release and potential FDA approval by year-end [96][97] - The NCCN updated its CRC screening guidelines to include Shield, which is expected to enhance commercial coverage and patient access [21][21] Q&A Session Summary Question: Did the New England Journal publication benefit Guardant360 Liquid in Q2? - Management noted that while growth was strong, any impact from the publication was minimal, with significant growth expected upon drug approval [42][44] Question: What is driving Shield's impressive growth? - Management attributed the growth to strong market demand, increased sales rep productivity, and the recent NCCN guideline inclusion [47][49] Question: What are the next steps for Shield to be marketed as an MSEAD test? - Management confirmed that Shield is operationally ready for patient testing and is not waiting for additional studies to broaden access [62][64] Question: How confident is management about Reveal Medicare reimbursement? - Management expressed high confidence based on previous experiences with Medicare coverage processes [76][78] Question: What is the timeline for Shield V2 data? - Management indicated that while there may be slight delays, significant work is ongoing, and they are not rushed to meet the timeline [96][97]

Financial Performance - Total revenue for Q2 2025 reached $232.1 million, a 31% increase compared to $177.2 million in Q2 2024[7, 40] - Oncology revenue grew by 22% year-over-year, reaching $158.7 million in Q2 2025, up from $130.3 million in Q2 2024[10, 40] - Biopharma & Data revenue experienced a 28% year-over-year growth, totaling $56 million in Q2 2025 compared to $44 million in Q2 2024[7, 29, 40] - Screening revenue for Q2 2025 was $14.8 million[7, 32, 40] - The company is raising revenue guidance for the full year 2025 to $915 million - $925 million, representing a 24%-25% year-over-year growth[48] Oncology Business - Oncology volume grew by 30% year-over-year[10] - Guardant360 Tissue ASP increased to approximately $2,000, achieving the company's 2028 target ahead of schedule[12] - Reveal identified that 63% of patients with detectable ctDNA experienced recurrence within three years, compared to 15% of those without detectable ctDNA[25] Screening Business - Shield's Q2 2025 revenue reached $15 million[32] - Shield volume in Q2 2025 was 16,000[32] - Shield non-GAAP gross margin improved significantly, reaching 48% in Q1 2025 and 18% in Q4 2024, and 2% in Q2 2025[42]