The market expects Guardant Health (GH) to deliver a year-over-year increase in earnings on higher revenues when it reports results for the quarter ended December 2023. This widely-known consensus outlook is important in assessing the company's earnings picture, but a powerful factor that might influence its near-term stock price is how the actual results compare to these estimates.The stock might move higher if these key numbers top expectations in the upcoming earnings report, which is expected to be rele ...

Guardant Health (GH) has been beaten down lately with too much selling pressure. While the stock has lost 12.9% over the past four weeks, there is light at the end of the tunnel as it is now in oversold territory and Wall Street analysts expect the company to report better earnings than they predicted earlier.Here is How to Spot Oversold StocksWe use Relative Strength Index (RSI), one of the most commonly used technical indicators, for spotting whether a stock is oversold. This is a momentum oscillator that ...

PALO ALTO, Calif.--(BUSINESS WIRE)--Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, will present interim data from the COSMOS study supporting the use of Guardant Reveal to predict disease recurrence in patients with early-stage colon cancer at the ASCO 2024 Gastrointestinal Cancers Symposium, January 18-20 in San Francisco. Guardant Reveal analyzes comprehensive molecular signals in the blood to detect and quantify minimal residual disease (MRD). The COSMOS study evaluated the ...

PALO ALTO, Calif., Jan. 8, 2024 /PRNewswire/ -- Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, and Hikma Pharmaceuticals PLC ("Hikma"), a multinational pharmaceutical company, today announced an agreement to promote Guardant Health's portfolio of liquid and tissue biopsy tests for cancer screening, recurrence monitoring and tumor mutation profiling for all solid cancers across the Middle East and North Africa (MENA). The partnership expands Guardant Health's global presence and in ...

PALO ALTO, Calif.--(BUSINESS WIRE)--Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced the addition of Terilyn Juarez Monroe as the company’s chief people officer, effective immediately. In the newly-created role, Monroe will lead the human resources function, including people operations; cultural and organizational transformation; talent acquisition; and diversity and inclusion initiatives. Amelia Merrill, who previously served as senior vice president of people, i ...

PALO ALTO, Calif.--(BUSINESS WIRE)--Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced that it has entered into a common stock purchase agreement with Baillie Gifford on behalf of accounts that it manages for the sale of 3,387,446 shares of its common stock in a registered direct offering at an offering price of $26.77 per share. Gross proceeds are approximately $90.7 million, before deducting expenses payable by Guardant Health. Guardant Health intends to use the n ...

Financial Data and Key Metrics Changes - Total revenue for Q3 2023 grew 22% to $143 million compared to $117.4 million in the prior year quarter [92] - Precision oncology testing revenue increased 31% to $133.4 million, driven by strong clinical and biopharma volumes [92] - Clinical test volume reached 43,900 tests, a 35% increase year-over-year [53][93] - Net loss for Q3 2023 was $86.1 million, a significant reduction from $162.0 million in Q3 2022 [101] Business Line Data and Key Metrics Changes - Clinical revenue from tests totaled $103.9 million, up 34% from $77.8 million in the prior year quarter [92] - Biopharma test volume was approximately 7,500 tests, an 11% increase year-over-year [96] - Development services and other revenue decreased by 37% to $9.6 million, primarily due to timing and amount of milestones related to partnerships [98] Market Data and Key Metrics Changes - Guardant360 ASP is trending towards the upper end of the $2,650 to $2,700 range, with a proposed increase to $5,000 effective January 1, 2024 [68][90] - The company has achieved over 200 million covered lives for TissueNext, indicating strong market penetration [110] Company Strategy and Development Direction - The company is focused on expanding its commercial team and enhancing customer experience through integrations with oncology EMR systems [56][38] - Plans to launch the Shield IVD in 2024, with ongoing advancements in MRD and screening technologies [76][87] - The company aims to achieve cash flow breakeven in therapy selection by the end of 2023 and manage annual screening cash burn to approximately $200 million [109] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving high 30s to low 40s growth for clinical volumes in 2023, with expectations for sequential uplift in Q4 [119] - The company anticipates continued growth in breast cancer testing and is optimistic about the upcoming data from the PEGASUS study [22][74] - Management highlighted the importance of reimbursement progress and legislative support for biomarker testing as key drivers for future growth [70][125] Other Important Information - The company is making significant progress in international markets, particularly in Japan and Europe, with recent regulatory approvals and partnerships [57][66] - The Shield test has shown promising results in increasing colorectal cancer screening compliance among patients [84][85] Q&A Session Summary Question: What is the anticipated mix between LDT and CDx following the pricing change? - The mix has shifted towards CDx, currently just over 50% on the CDx side, and the pricing change is not expected to alter this significantly [107][112] Question: What are the implications of the PEGASUS study results? - The results suggest potential for de-escalation of chemotherapy based on negative MRD results, which could influence standard care practices [115][116] Question: What is the outlook for MRD testing inclusion in NCCN guidelines? - Conversations with payers are ongoing, and state biomarker bills are seen as catalysts for quicker coverage [125]

Shield CRC Screening Test - Shield V2 demonstrated improved clinical sensitivity relative to Shield V1, with CRC sensitivity at 91% (41/45) compared to V1's 84% (38/45) [5, 6, 8] - In Stage I/II CRC, Shield V2 showed 88% (22/25) sensitivity, while V1 had 76% (19/25) sensitivity [10] - Adding Shield to the standard of care increases compliance meaningfully [3] - Patients were more than 2x more likely to complete CRC screening when offered a blood-based test like Shield [37] - The company is blazing a trail to the first FDA approved and reimbursed CRC screening test [21] Financial Performance and Growth - Total revenue reached $143 million, with precision oncology revenue at $133.4 million, a 31% year-over-year growth [35, 50] - Clinical volumes increased to 43900 [45] - Biopharma volumes grew by 11% year-over-year [25] - The company is raising its guidance for FY 2023 revenue to $553 - $556 million, representing 23-24% year-over-year growth [63] Therapy Selection and MRD - Guardant360 ASP is trending to $2700 due to recent commercial coverage [18] - Interim data from the PEGASUS study suggests Reveal can be used to help modulate therapy for CRC patients, with 34% of patients with a positive liquid biopsy result after surgery experiencing cancer relapse despite adjuvant chemotherapy, compared to only 10% of patients with a negative result [19]

Financial Performance - Total revenue for Q3 2023 was $143.03 million, a 21.8% increase from $117.40 million in Q3 2022[16] - Precision oncology testing revenue reached $133.42 million, up 30.7% from $102.05 million year-over-year[16] - Net loss for Q3 2023 was $86.10 million, compared to a net loss of $161.99 million in Q3 2022, representing a 46.8% improvement[16] - The company reported a comprehensive loss of $83.31 million for Q3 2023, compared to a comprehensive loss of $164.59 million in Q3 2022[20] - For the nine months ended September 30, 2023, the net loss was $292,406 thousand, a decrease from the net loss of $514,654 thousand for the same period in 2022, representing a 43% improvement[29] - Total revenue for the three months ended September 30, 2023, was $143.0 million, up from $117.4 million in 2022, representing a 21.8% increase[162] - Net loss for the three months ended September 30, 2023, was $86.1 million, compared to a net loss of $162.0 million in 2022[158] Assets and Cash Position - Total assets increased to $1.80 billion as of September 30, 2023, from $1.61 billion at the end of 2022[14] - Cash and cash equivalents rose significantly to $457.34 million from $141.65 million at the end of 2022[14] - Total cash, cash equivalents, and restricted cash increased to $457,363 thousand as of September 30, 2023, compared to $158,612 thousand at the end of the same period in 2022[30] - The total fair value of financial assets was $1,176.0 million, an increase from $905.9 million as of December 31, 2022[91] - As of September 30, 2023, cash and cash equivalents totaled $457.3 million, with short-term marketable debt securities amounting to $697.5 million[247] Stockholder Equity and Shares - Total stockholders' equity increased to $228.30 million as of September 30, 2023, from $60.18 million at the end of 2022[14] - The company had 117.85 million shares outstanding as of September 30, 2023, compared to 102.62 million shares at the end of 2022[14] - The total shares available for issuance under various plans increased to 25,109,231 from 16,249,546 as of December 31, 2022, reflecting a significant growth in potential equity compensation[129] Research and Development - Research and development expenses for Q3 2023 were $93.85 million, slightly down from $100.02 million in Q3 2022[16] - Research and development expense for the nine months ended September 30, 2023, was $25.4 million, an increase from $18.5 million in 2022[146] - The Company’s research and development expenses include costs for technology development, totaling significant amounts for compensation, supplies, and infrastructure[75] Investments and Impairments - The Company recorded an impairment of $22.1 million for non-marketable equity security investments for the nine months ended September 30, 2023[42] - The Company’s non-marketable equity investments totaled $8.6 million as of September 30, 2023, down from $25.0 million as of December 31, 2022[41] - The investment in Lunit Inc. was valued at $102.8 million as of September 30, 2023, up from $18.3 million at the end of 2022, with unrealized gains of $16.6 million for Q3 2023[93] Revenue Recognition and Customer Concentration - Revenue from significant customer B accounted for 33% of total revenue for the three months ended September 30, 2023[46] - The Company evaluates contracts with multiple performance obligations to ensure appropriate revenue recognition, allocating transaction prices based on standalone selling prices[69] - The Company recognized revenue from companion diagnostic development and regulatory approval services over the period in which biopharmaceutical research and development services are provided, using an input method based on costs incurred[65] Stock-Based Compensation - Stock-based compensation for the nine months ended September 30, 2023, was $66,439 thousand, slightly lower than $70,982 thousand for the same period in 2022[29] - Total stock-based compensation expense for the three months ended September 30, 2023, was $21.8 million, compared to $20.6 million for the same period in 2022[146] - The weighted-average grant date fair value of options granted was $24.42 for the three months ended September 30, 2023, compared to $33.66 for the same period in 2022[134] Debt and Interest - Interest income for Q3 2023 was $11.69 million, a significant increase from $1.75 million in Q3 2022[16] - Interest expense related to amortization of debt issuance costs was $0.6 million for the three months ended September 30, 2023, maintaining an effective interest rate of 0.2%[113] - The net carrying amount of the 2027 Convertible Senior Notes is $1.14 billion as of September 30, 2023, slightly up from $1.14 billion at the end of 2022[112] Operational Activities - The company reported a net cash used in operating activities of $246,247 thousand for the nine months ended September 30, 2023, compared to $218,714 thousand for the same period in 2022[29] - Cash provided by investing activities for the nine months ended September 30, 2023, was $176,796 thousand, compared to $79,189 thousand for the same period in 2022[29] Regulatory and Legal Matters - The company is fully cooperating with a Civil Investigative Demand related to the billing of government-funded programs for its genetic tests, but is unable to predict the outcome[127] - The Company has a collaboration agreement with Illumina, Inc. to advance cancer research and has dismissed a related lawsuit[125] Currency and Foreign Operations - The majority of the company's revenue is generated in the United States, with an insignificant amount from foreign currencies as of September 30, 2023[248] - The company anticipates that its results of operations and cash flows will increasingly be affected by fluctuations in foreign currency exchange rates as it expands internationally[248] - A hypothetical 10% change in foreign currency exchange rates would not be material to the company's financial condition or results of operations as of September 30, 2023[248]

Financial Data and Key Metrics Changes - Total revenue for Q2 2023 grew 26% to $137.2 million compared to $109.1 million in the prior year quarter [85] - Precision oncology revenue increased 36% to $125.2 million in Q2 2023 from $92.1 million in the prior year quarter [85] - Net loss for Q2 2023 was $72.8 million or $0.67 per share, a reduction from a net loss of $229.4 million or $2.25 per share in Q2 2022 [61] Business Line Data and Key Metrics Changes - Clinical test volume reached 43,500, an increase of 49% year-over-year and up 11% from Q1 2023 [36] - MRD (Minimal Residual Disease) testing revenue from Reveal grew over 100% year-over-year [80] - Development Services and other revenue totaled $11.9 million, down 30% from the prior quarter due to timing and project milestones [50] Market Data and Key Metrics Changes - The company secured coverage from major U.S. insurers, including Anthem and Blue Cross Blue Shield, covering over $300 million of lives for Guardant360 tests [55] - Japan represents a significant expansion opportunity, with national reimbursement approval for Guardant360 effective at the end of July [46] - The overall screening rate for lung cancer is less than 15%, indicating a large potential market for growth [48] Company Strategy and Development Direction - The company aims to transform cancer diagnostics through innovative technology and is focused on high-impact opportunities in MRD and screening [64] - Plans to launch the next-generation SHIELD test in 2024, with a focus on expanding indications to lung cancer [47] - The company is committed to achieving cash flow breakeven in therapy selection within the next 3 to 6 months [90] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving revenue growth of approximately 21% to 22% for the full year 2023, raising guidance from previous expectations [64] - The company is optimistic about the potential for increased ASPs (Average Selling Prices) as new payer contracts are finalized [67] - Management acknowledged the challenges in the biopharma segment but remains focused on growth opportunities [119] Other Important Information - The company raised $381 million in net proceeds from an equity offering, providing a strong cash position of approximately $1.2 billion [89] - The gross margin for Q2 2023 was 61%, down from 66% in the prior year quarter, influenced by the mix of clinical and biopharma revenue [60] - The company is targeting an operating loss from its screening pipeline of approximately $200 million per year over the next five years [63] Q&A Session Summary Question: What is the contribution from the Japan market expected to be over the next couple of years? - Management indicated that while minimal revenue is expected in the current year, they anticipate material contributions starting in 2024 as the market develops [115] Question: Can you provide context around the contribution of Reveal in the quarter? - Management noted that Reveal volume grew over 100% and is on track for low double-digit million revenue contributions [71] Question: What are the expectations around the spend levels for MRD? - Management emphasized a focus on managing investments closely while driving market penetration and data generation in the MRD segment [120]