Financial Performance - Total revenue for Q1 2025 reached $203.5 million, a 21% increase compared to $168.5 million in Q1 2024[7, 45] - Oncology revenue grew by 20% year-over-year, reaching $150.6 million in Q1 2025 compared to $125.7 million in Q1 2024[10, 45] - Biopharma & Data revenue increased by 21% year-over-year, reaching $45.4 million in Q1 2025 compared to $37.6 million in Q1 2024[7, 27, 45] - Screening revenue for Q1 2025 was $5.7 million[7, 30, 45] - The company is raising revenue guidance for the full year 2025 to $880 million - $890 million, representing a 19%-20% year-over-year growth[52] Product and Technology Updates - Oncology volume increased by 25% year-over-year[10] - Guardant360 ASP improved to $3,000-$3,100[11] - Launched upgraded Guardant360 Tissue, a broad multiomic tissue CGP test[14, 15] - Reveal CRC & Shield are gross margin positive following significant COGS reductions[46] Screening - Shield Q1 '25 Revenue is $5.7M and Volume is 9K[30] - Shield has achieved positive gross margin ahead of schedule[36] - Improved Medicare pricing for CRC screening from $920 to $1,495, effective April 1, 2025[34]

Revenue Performance - Revenue for the three months ended March 31, 2025, was $203,471,000, representing a 20.7% increase from $168,491,000 in the same period of 2024[15] - Total revenue for the three months ended March 31, 2025, was $203.471 million, a 20.7% increase from $168.491 million in the same period of 2024[151] - Oncology revenue reached $150.559 million, up 19.7% from $125.748 million year-over-year[50] - Biopharma and data revenue increased to $45.376 million, representing a 20.7% growth compared to $37.587 million in the prior year[50] - Screening revenue was $5.677 million, with no prior year comparison available[50] - Revenue from significant customers included 29% from Customer B and 18% from Customer C for the three months ended March 31, 2025[42] - Revenue from the United States was $193.609 million in Q1 2025, a 23.0% increase from $157.348 million in Q1 2024[152] - International revenue decreased to $9.862 million in Q1 2025 from $11.143 million in Q1 2024, a decline of 11.5%[152] Costs and Expenses - Total costs and operating expenses increased to $314,512,000 for the three months ended March 31, 2025, up from $268,174,000 in 2024, reflecting a 17.3% rise[15] - Research and development expenses for the first quarter of 2025 were $88,521,000, compared to $83,802,000 in 2024, marking a 5.2% increase[15] - Cost of revenue for Q1 2025 was $72.185 million, up from $63.170 million in Q1 2024, reflecting a 17.0% increase[151] - Total accrued expenses increased to $76.0 million as of March 31, 2025, compared to $68.3 million as of December 31, 2024, driven by higher operating lease liabilities and other accrued expenses[75] Net Loss and Financial Position - The net loss for the first quarter of 2025 was $95,159,000, compared to a net loss of $114,985,000 in the same quarter of 2024, indicating a 17.3% improvement[15] - The company reported a basic and diluted net loss per share of $0.77 for the first quarter of 2025, an improvement from $0.94 in the same quarter of 2024[15] - The net loss for the three months ended March 31, 2025, was $95.2 million, an improvement from a net loss of $115.0 million in the same period of 2024, representing a 17% decrease in losses[26] - The company had a total stockholders' deficit of $250,789,000 as of March 31, 2025, worsening from a deficit of $139,647,000 at the end of 2024[13] Cash and Liquidity - Cash and cash equivalents increased to $698,572,000 as of March 31, 2025, up from $525,540,000 at the end of 2024, showing a 32.8% growth[13] - Cash, cash equivalents, and restricted cash at the end of the period totaled $803.9 million, down from $1.1 billion at the end of Q1 2024, reflecting a decrease of approximately 29%[26] - The fair value of cash equivalents and restricted cash was $753.0 million as of March 31, 2025, up from $590.0 million as of December 31, 2024, primarily due to increases in U.S. government debt securities[80][81] - The total cash equivalents and restricted cash increased by approximately 27.6% from December 31, 2024, to March 31, 2025, reflecting improved liquidity management[80][86] Investments and Impairments - The company recorded an impairment of $5.0 million for non-marketable equity securities in Q1 2025, following a prior impairment of $22.1 million in fiscal year 2023[38] - The company recorded $30.1 million in unrealized losses on its investment in Lunit for the three months ended March 31, 2024, reflecting market volatility post-IPO[82] - The fair value of money market funds was $3.7 million as of March 31, 2025, a decrease from $57.2 million as of December 31, 2024, indicating a shift in investment strategy[86] Stockholder Equity and Compensation - The total stock-based compensation expense was $37.8 million, an increase from $27.0 million in the same period of 2024[137] - Future stock-based compensation for unvested options as of March 31, 2025, is estimated at $48.8 million, expected to be recognized over a weighted-average period of 2.3 years[130] - The balance of restricted stock units as of March 31, 2025, was 8,430,026, with a weighted-average grant date fair value of $33.34[131] - The total intrinsic value of options exercised was $1.1 million for the three months ended March 31, 2025, compared to $0.6 million for the same period in 2024[129] Regulatory Approvals and Product Development - The Guardant360 LDT and Guardant360 CDx tests are now FDA-approved for tumor mutation profiling, enhancing the company's product offerings in precision oncology[28] - The Shield LDT test for colorectal cancer screening received FDA approval in July 2024 and became commercially available in August 2024, marking a significant milestone for early cancer detection[30] Debt and Interest - The outstanding principal amount of the 2027 Notes is $490.7 million as of March 31, 2025, down from $1.150 billion as of December 31, 2024[105] - Total interest expense recognized for the three months ended March 31, 2025, was $791,000, an increase from $645,000 in 2024[106] - The effective interest rate for the 2027 Notes is 0.2%, while the effective interest rate for the 2031 Notes is 0.4%[106] Future Outlook and Risks - The Company expects to recognize substantially all remaining transaction price allocated to performance obligations in the next 1-2 years[63] - The company expects future operations and cash flows to be increasingly affected by foreign currency exchange rate fluctuations as it expands internationally[219] - A hypothetical 100 basis point change in interest rates would have an immaterial impact on the fair value of the company's investments as of March 31, 2025[218]

Financial Data and Key Metrics Changes - Q1 2025 total revenue grew 21% year over year to $203.5 million, driven largely by oncology revenue which increased 20% to $150.6 million [6][27] - Non-GAAP gross margin improved to 65% in Q1 2025, up from 63% in Q1 2024, primarily due to improved oncology ASPs and significant reductions in COGS for Reveal and Shield [32] - Adjusted EBITDA loss was $58.5 million for Q1 2025, an improvement from a loss of $61.1 million in Q1 2024 [33] Business Line Data and Key Metrics Changes - Oncology revenue increased 20% year over year to $151 million, with volumes growing 25% to approximately 59,000 tests in Q1 2025 [6][27] - Biopharma and data revenue grew 21% year over year to $45.4 million, supported by increasing partnerships and volume leveraging methylation analysis [15][28] - Screening revenue from Shield totaled $5.7 million in Q1 2025, driven by approximately 9,000 tests [17][29] Market Data and Key Metrics Changes - Guardant360 ASP improved to the range of $3,000 to $3,100 in Q1 2025, compared to approximately $3,000 in Q4 2024, due to better reimbursement from Medicare Advantage and commercial payers [8][27] - Shield received ADLT status, increasing the Medicare price from $920 to $1,495 effective April 1, which is expected to enhance ASP and volume [18][50] Company Strategy and Development Direction - The company aims to support patients throughout their cancer journey, focusing on early detection, monitoring recurrence, and treatment selection [4][5] - Continued investment in EMR integrations is expected to improve ordering depth per account, enhancing overall business performance [8][15] - The launch of upgraded products like Guardant360 Tissue is intended to leverage the smart liquid biopsy platform, providing a comprehensive testing solution [10][11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving cash flow breakeven by 2028, with cumulative free cash outflow projected between $450 million to $550 million over the next three years [34][37] - The company anticipates total oncology volume to grow greater than 25% in 2025, driven by strong product performance and improved reimbursement [35][36] - Management highlighted the importance of both liquid and tissue testing modalities, suggesting that both will be standard care for patients in the future [71] Other Important Information - The company reported that both Reveal and Shield became gross margin positive in Q1 2025, with significant cost reductions achieved [30][31] - The company is focused on cash management and reducing burn rates, with a free cash flow burn of $67 million in Q1 2025, influenced by the timing of annual bonus payouts [33][34] Q&A Session Summary Question: What are the drivers for the accelerated growth in oncology volume? - Management noted strong growth from Guardant360 due to recent product upgrades and the positive market fit for liquid biopsy in therapy selection [42][44] Question: Can you elaborate on the components of the raised guidance for Shield? - Management indicated that improved sales force productivity and the recent ADLT status for Shield contributed to the raised guidance, with expectations for ASP to increase to around $800 [45][50] Question: What is the market share in tissue testing and long-term expectations? - Management acknowledged that the tissue market share is currently small but expects significant growth potential due to the new product's capabilities and market demand [97]

Financial Data and Key Metrics Changes - The company reported Q1 revenue of $203.5 million, a 21% year-over-year increase [7][28] - Oncology revenue grew 20% year-over-year to $150.6 million, with volumes increasing 25% to approximately 59,000 tests [29][30] - Non-GAAP gross margin improved to 65% from 63% year-over-year, driven by better ASPs and reduced costs [34] Business Line Data and Key Metrics Changes - Oncology business revenue increased 20% year-over-year, with Guardant360 and Reveal being the main growth drivers [29][30] - Biopharma and data revenue also grew 21% year-over-year, totaling $45.4 million [31] - Screening revenue from Shield reached $5.7 million, driven by approximately 9,000 tests [32] Market Data and Key Metrics Changes - Guardant360 ASP improved to the range of $3,000 to $3,100, benefiting from better reimbursement rates [9][30] - Shield received ADLT status, increasing its Medicare price from $920 to $1,495, effective April 1 [20][54] - The company expects Shield revenue to be between $40 million and $45 million for 2025, up from previous guidance of $25 million to $30 million [37] Company Strategy and Development Direction - The company aims to support patients throughout their cancer journey, focusing on early detection, monitoring, and treatment selection [5][6] - There is a strong emphasis on expanding the oncology portfolio and enhancing the capabilities of both liquid and tissue tests [12][16] - The company plans to reinvest gross profits from Shield into commercial infrastructure to accelerate growth [40] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving cash flow breakeven by 2028, with cumulative cash outflow expected to be between $450 million and $550 million over the next three years [36][40] - The company anticipates continued growth in oncology volumes and ASPs, driven by recent product upgrades and Medicare coverage [37][39] - Management highlighted the importance of both liquid and tissue testing modalities, suggesting that both will become standard care for patients [72] Other Important Information - The company achieved gross margin positivity for both Reveal and Shield in Q1 2025, with significant cost reductions [32][33] - The Guardant360 Tissue test was launched, requiring 40% less tissue than competitors, enhancing its market appeal [12][71] Q&A Session Summary Question: Can you rank the opportunities for Guardant360's growth? - Management noted strong growth driven by product upgrades and market fit, with Reveal also showing accelerating growth [45][46] Question: What are the components of the raised guidance for Shield? - Management discussed the positive impact of ADLT status and the potential for increased sales force productivity [49][50] Question: What is the ASP for Guardant360 and how does it relate to Medicare? - The ASP for Guardant360 is now expected to be between $3,000 and $3,100, with improvements from Medicare Advantage reimbursements [59][60] Question: What is the market share for the new tissue product? - Management indicated that the new tissue product is expected to capture significant market share due to its unique features and capabilities [98]

Revenue Performance - Revenue for Q1 2025 was $203.5 million, a 21% increase from $168.5 million in Q1 2024[4] - Total revenue for the three months ended March 31, 2025, was $203,471,000, representing a 20.7% increase from $168,491,000 in the same period of 2024[28] - The company raised its 2025 revenue guidance to $880 to $890 million, representing growth of 19% to 20%[1] Oncology Revenue - Oncology revenue grew 20% to $150.6 million, driven by a 25% increase in oncology test volume[4] - Oncology revenue increased to $150,559,000, up 19.7% from $125,748,000 year-over-year[28] Screening Revenue - Screening revenue was $5.7 million from approximately 9,000 Shield screening tests[5] - The company expects full year 2025 screening revenue to be in the range of $40 to $45 million, driven by Shield volume of 52,000 to 58,000 tests[14] Profitability and Margins - Gross profit was $128.7 million with a gross margin of 63%, up from 61% in the prior year[6] - GAAP gross profit for Q1 2025 was $128,748,000, up from $103,195,000 in Q1 2024, marking a 24.8% increase[30] - Guardant Health achieved positive gross margins for both Reveal and Shield in Q1 2025[5] Net Loss and Cash Flow - Net loss for Q1 2025 was $95.2 million, an improvement from a net loss of $115.0 million in Q1 2024[9] - GAAP net loss for Q1 2025 was $95,159,000, compared to a net loss of $114,985,000 in Q1 2024, reflecting a 17.3% improvement[31] - Non-GAAP net loss per share for Q1 2025 was $0.49, slightly higher than $0.46 in Q1 2024[31] - Free cash flow for the three months ended March 31, 2025, was $(67,148,000), compared to $(37,218,000) in the same period of 2024, indicating increased cash usage[35] Expenses and Liabilities - Research and development expenses for Q1 2025 were $88,521,000, compared to $83,802,000 in Q1 2024, reflecting a 5.2% increase[30] - Total assets decreased to $1,344,226,000 as of March 31, 2025, down from $1,485,609,000 at the end of 2024[26] - Total liabilities decreased to $1,595,015,000 as of March 31, 2025, compared to $1,625,256,000 at the end of 2024[26] - Total stockholders' deficit increased to $(250,789,000) as of March 31, 2025, from $(139,647,000) at the end of 2024[26] Pricing - Guardant360 average selling price (ASP) increased to $3,000 to $3,100 per test[5]

Group 1 - Guardant Health (GH) is expected to report a year-over-year decline in earnings, with a projected loss of $0.61 per share, representing a -32.6% change, while revenues are anticipated to be $191.1 million, up 13.4% from the previous year [3][10] - The earnings report is scheduled for April 30, 2025, and could influence the stock price depending on whether the results exceed or fall short of expectations [2][12] - The consensus EPS estimate has remained unchanged over the last 30 days, indicating a stable outlook from covering analysts [4] Group 2 - The Most Accurate Estimate for Guardant Health is lower than the Zacks Consensus Estimate, resulting in an Earnings ESP of -38.35%, suggesting a bearish sentiment among analysts [10][11] - Guardant Health has a Zacks Rank of 3, making it challenging to predict an earnings beat conclusively [11] - Historically, Guardant Health has beaten consensus EPS estimates three times over the last four quarters, but the last reported quarter showed a surprise miss of -24% [12][13] Group 3 - In comparison, Repligen (RGEN) is expected to post earnings of $0.35 per share for the same quarter, indicating a year-over-year increase of +25%, with revenues projected at $164.48 million, up 8.7% [17] - Repligen's consensus EPS estimate has been revised 0.4% lower in the last 30 days, but a higher Most Accurate Estimate has resulted in an Earnings ESP of 3.77%, indicating a likelihood of beating the consensus [18]

Core Insights - Guardant Health, Inc. is a biopharma company focused on liquid biopsy tests primarily for oncology applications, utilizing genomic and digital technology to analyze patients' DNA samples [1] Company Overview - The company specializes in developing liquid biopsy tests for various illnesses, with a strong emphasis on cancer-related applications [1] Technology and Approach - Guardant Health employs advanced genomic and digital technologies to conduct analyses of DNA samples from patients, which is central to their testing methodology [1]

Group 1 - The Centers for Medicare & Medicaid Services (CMS) approved the Advanced Diagnostic Laboratory Test (ADLT) status for Guardant Health's GH Shield blood test for colorectal cancer screening [1] - The FDA approved the Shield test in July 2024 as the first blood test for primary colorectal cancer screening, and Medicare already covers the test [1] - Starting April 1, the Shield test will be reimbursed at $1,495 during the initial nine-month ADLT period [1] Group 2 - During the initial ADLT period, Guardant Health will collect and submit private-payer payment rate data for the Shield test, with the median rate to be used by CMS for Medicare pricing starting January 1, 2026 [2] - The median rate will determine the payment amount for the Shield test from January 1, 2026, to December 31, 2027 [2] Group 3 - Palmetto GBA granted coverage for the Guardant Reveal test to monitor disease recurrence in colorectal cancer patients following curative intent therapy [3] - Securing ADLT status is seen as key to increasing average selling prices (ASPs) beyond previous guidance assumptions [3] - Analyst Andrew Brackmann views the update favorably and maintains an Outperform rating for Guardant Health [3] Group 4 - The ADLT status and price increase were not included in Shield's previous revenue guidance, which projected annual screening revenue between $25 million and $30 million, with volumes of 45,000 to 50,000 [4] - The increase in Medicare reimbursement from $920 to $1,495 could potentially add around $10 million in additional revenue, assuming the same mix as previously estimated [4] Group 5 - Guardant Health's stock price increased by 14.5% to $41.04 following the news [5]

Group 1 - Guardant Health (GH) is currently outperforming its Medical peers with a year-to-date return of 38.9%, compared to the average gain of 6.2% for Medical stocks [4] - The Zacks Consensus Estimate for GH's full-year earnings has increased by 4% over the past quarter, indicating stronger analyst sentiment and an improving earnings outlook [4] - Guardant Health is ranked 2 (Buy) in the Zacks Rank system, which highlights stocks with characteristics likely to outperform the market in the next one to three months [3] Group 2 - Guardant Health is part of the Medical - Biomedical and Genetics industry, which consists of 510 companies and is currently ranked 66 in the Zacks Industry Rank [6] - The Medical - Biomedical and Genetics industry has gained an average of 7% year-to-date, indicating that Guardant Health is performing better than its industry peers [6] - Brookdale Senior Living (BKD) is another Medical stock that has outperformed its sector with a year-to-date return of 12.1% and also holds a Zacks Rank of 2 (Buy) [5]

Financial Data and Key Metrics Changes - Q4 2024 revenue grew 30% year-over-year to $202 million, with total full-year revenue reaching $739 million, an increase of 31% year-over-year [14][48] - Clinical revenue increased 34% year-over-year, supported by ASPs and reimbursement tailwinds, with total oncology clinical volumes in Q4 increasing 24% year-over-year [14][44] - Non-GAAP gross margin improved to 63% in Q4 2024 from 61% in Q4 2023, and for the full year, it was 62% compared to 61% in 2023 [52][54] Business Line Data and Key Metrics Changes - Guardant360 test volumes saw double-digit growth in 2024, contributing significantly to clinical test volume growth of 20% for the full year [14][48] - The Guardant Reveal test, which received Medicare coverage for CRC surveillance, is expected to reach an important inflection point in 2025, with significant volume growth anticipated [22][27] - Biopharma revenue grew 31% year-over-year, driven by partnerships and the Smart Liquid Biopsy platform, which now represents over 50% of reported samples in new contracts [28][44] Market Data and Key Metrics Changes - The Shield assay received FDA approval and Medicare coverage for CRC screening, opening a market for early cancer detection with a favorable Medicare price of $920 [35][36] - The company is exploring international opportunities, including a screening program in Abu Dhabi, aiming to screen approximately 10,000 patients in the first year [39][121] - The NCCN guideline updates are increasingly recognizing the value of ctDNA testing, which supports the commercial strategy for Reveal [23][75] Company Strategy and Development Direction - The company aims to accelerate volume growth and product innovation in 2025, particularly in the Therapy Selection portion of its oncology business [10][21] - The transition to the Smart Liquid Biopsy platform is expected to enhance the capabilities of Guardant360 and drive greater depth of ordering [18][20] - The company plans to present revenue in four components for better clarity on performance, including Oncology, Biopharma and Data, Licensing and Other, and Screening [59] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving cash flow break-even by 2028, with cumulative free cash outflows expected to be between $450 million and $550 million over the next three years [58][65] - The company anticipates full-year 2025 revenues in the range of $850 million to $860 million, representing growth of approximately 15% to 16% compared to 2024 [60] - Management highlighted the importance of the upcoming ACS guidelines and ADLT status for Shield, which could further enhance ASPs and market penetration [62][124] Other Important Information - The company successfully reduced COGS for Reveal by over 50% in 2024, which is expected to contribute to improved gross margins in 2025 [25][63] - A significant litigation expense related to a false advertising trial resulted in a favorable outcome for the company, awarding $293 million [53] - The company ended the year with approximately $944 million in cash and equivalents, following a successful private convertible debt exchange [56] Q&A Session Summary Question: Can you discuss the sales force expansion for Shield and the expected contribution to revenue? - Management indicated that the sales force for Shield was increased from 50 to 100 reps, with expectations for a back-end loaded ramp in productivity due to the timing of new hires [70][72] Question: How does the NCCN guideline update affect Reveal's adoption? - Management expressed encouragement regarding the NCCN guidelines, viewing it as a step forward in recognizing the value of ctDNA testing, and they are confident in future adoption [74][75] Question: Are there discussions with commercial payers regarding Shield? - Early conversations with commercial payers are ongoing, with plans to ramp up engagement following guideline updates [78] Question: What ASP is embedded in the guidance for Reveal? - The expected ASP for Reveal is approximately $600, not including potential increases from ADLT designation [99] Question: What is the expected impact of the ACS guidelines on Shield? - Management anticipates that inclusion in ACS guidelines could serve as a catalyst for increased adoption and revenue, although it is not yet included in current guidance [124]