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Guardant Health(GH) - 2022 Q4 - Annual Report
2023-02-22 16:00
WASHINGTON, DC 20549 _____________________ FORM 10-K _____________________ (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 UNITED STATES SECURITIES AND EXCHANGE COMMISSION For the fiscal year ended December 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-38683 GUARDANT HEALTH, INC. (Exact Name of Registrant as Specified in its Charter) _______ ...
Guardant Health(GH) - 2022 Q3 - Earnings Call Transcript
2022-11-04 02:52
Financial Data and Key Metrics Changes - Guardant Health reported record revenue of $117 million for Q3 2022, representing a 24% increase year-over-year [12][45] - Precision oncology revenue reached $102.1 million, up 29% compared to the prior year [45] - Gross profit for Q3 2022 was $76.9 million, with a gross margin of 66%, slightly down from 67% in the prior year [52] - The net loss for Q3 2022 was $162 million, or $1.58 per share, compared to a net loss of $107.5 million, or $1.06 per share, in Q3 2021 [53] Business Line Data and Key Metrics Changes - Clinical test volume increased to over 32,400 tests, a 42% rise compared to the prior year [13][47] - Biopharma volume reached 6,750 samples, up 40% year-over-year [17][50] - Development services and other revenue totaled $15.4 million, down 1% from the prior year [51] Market Data and Key Metrics Changes - The company noted a significant increase in the number of oncologists ordering multiple Guardant products, contributing to growth despite staffing shortages and access restrictions [14][60] - The Medicare reimbursement rate for Guardant Reveal for colorectal cancer increased from approximately $3,600 to over $4,900 [16][46] Company Strategy and Development Direction - Guardant Health is focused on expanding its oncology product pipeline and enhancing its commercial infrastructure, particularly for the Shield LDT test [55][65] - The company aims to address the unmet need in colorectal cancer screening, targeting the noncompliant population with its Shield test [11][27] - Guardant Health is optimistic about the potential of its new smart liquid biopsy platform, Guardant Infinity, which is expected to drive future growth [18][23] Management's Comments on Operating Environment and Future Outlook - Management acknowledged challenges in the operating environment, including staffing shortages and lingering access restrictions, which have impacted growth expectations [59][60] - Despite lowering revenue guidance for 2022 to a range of $440 million to $450 million, management remains confident in the core business's strength, citing a 40% year-over-year volume growth [58][63] - The company is preparing for continued growth in 2023, although it anticipates a lower growth rate compared to previous expectations [100] Other Important Information - The company has a strong cash position, ending Q3 2022 with approximately $1.1 billion in cash and equivalents, allowing it to fund operations for the foreseeable future [57] - Guardant Health is actively pursuing FDA approval for its Shield test and plans to submit its final PMA module for the ECLIPSE study in Q4 [26][65] Q&A Session Summary Question: Timeline and learnings from the Shield launch - Management confirmed that the ECLIPSE trial readout is expected in Q4, with database locking imminent [71] - Performance data from the Shield LDT is anecdotal, making it difficult to assess true sensitivity and specificity [72] Question: Staffing challenges and competition - Management noted that while growth is strong, it has not met initial expectations due to slower recovery from COVID-19 impacts [75] - The company believes it is still gaining market share in the liquid biopsy field despite competitive pressures [77] Question: Reveal reimbursement and cost management - The price increase for Reveal was due to ongoing discussions with MolDX, reflecting the test's value [81] - Management is carefully managing operating expenses to mitigate the impact of reduced revenue guidance [84] Question: Future growth expectations - Management is cautious about providing specific 2023 guidance but is comfortable with a growth rate around 20% based on current trends [100] Question: Shield test commercialization and sales force - The current sales force is about 100 people, with plans to expand as the company builds ASP and approaches FDA approval [115]
Guardant Health(GH) - 2022 Q3 - Earnings Call Presentation
2022-11-03 23:31
Q3 2022 Earnings Call November 3, 2022 Safe Harbor Certain statements in this presentation and the accompanying oral commentary are forward-looking statements within the meaning of federal securities laws. These statements relate to future events or Guardant Health, Inc. (the "Company")'s future results and involve known and unknown risks, uncertainties and other factors that may cause the actual results, levels of activity, performance or achievements of the Company or its industry to be materially differe ...
Guardant Health(GH) - 2022 Q3 - Quarterly Report
2022-11-02 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 _____________________ FORM 10-Q _____________________ (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-38683 _____________________ GUARDANT HEALTH, INC. (Exact Name of Registrant as Sp ...
Guardant Health(GH) - 2022 Q2 - Earnings Call Transcript
2022-08-05 03:00
Guardant Health, Inc. (NASDAQ:GH) Q2 2022 Earnings Conference Call August 4, 2022 4:30 PM ET Company Participants Alex Kleban - Vice President, Investor Relations Helmy Eltoukhy - Co-Chief Executive Officer AmirAli Talasaz - Co-Chief Executive Officer Mike Bell - Chief Financial Officer Conference Call Participants Puneet Souda - SVB Securities Jack Meehan - Nephron Research Mark Massaro - BTIG Brian Weinstein - William Blair Kyle Mikson - Canaccord Matt Sykes - Goldman Sachs Daniel Macek - Stifel David We ...
Guardant Health(GH) - 2022 Q2 - Earnings Call Presentation
2022-08-05 00:37
Q2 2022 Earnings Call August 4, 2022 Safe harbor Certain statements in this presentation and the accompanying oral commentary are forward-looking statements within the meaning of federal securities laws. These statements relate to future events or Guardant Health, Inc. (the "Company")'s future results and involve known and unknown risks, uncertainties and other factors that may cause the actual results, levels of activity, performance or achievements of the Company or its industry to be materially different ...
Guardant Health(GH) - 2022 Q2 - Quarterly Report
2022-08-03 16:00
Revenue Performance - Total revenue for the three months ended June 30, 2022, was $109,144,000, representing a 18.5% increase from $92,101,000 in the same period of 2021[17]. - Precision oncology testing revenue increased to $92,062,000 for the three months ended June 30, 2022, up 26.7% from $72,604,000 in the prior year[17]. - The company’s revenue from the United States for the three months ended June 30, 2022, was $100.836 million, up from $87.868 million in the same period of 2021, marking an increase of approximately 14.1%[170]. - Revenue from clinical tests for patients covered by Medicare represented approximately 45% of precision oncology revenue from clinical customers for the three months ended June 30, 2022[180]. - Revenue from clinical customers for precision oncology testing was $70.5 million for the three months ended June 30, 2022, a 15% increase from $61.1 million for the same period in 2021[209]. - Revenue from biopharmaceutical customers for precision oncology testing was $21.6 million for the three months ended June 30, 2022, compared to $11.6 million for the same period in 2021[210]. Financial Losses - The net loss for the three months ended June 30, 2022, was $229,432,000, compared to a net loss of $97,575,000 for the same period in 2021, reflecting a significant increase in losses[17]. - The company reported a comprehensive loss of $235,379,000 for the three months ended June 30, 2022, compared to a comprehensive loss of $98,446,000 in the same period of 2021[20]. - For the three months ended June 30, 2022, the net loss was $229,432 thousand, compared to a net loss of $97,575 thousand for the same period in 2021, representing an increase in loss of approximately 134%[24]. - The net loss attributable to common stockholders was calculated at $0.75 per share for the period, with diluted net loss per share also reflecting the same amount due to anti-dilutive effects[84]. - The net loss attributable to Guardant Health, Inc. common stockholders for the three months ended June 30, 2022, was $229.432 million, compared to a net loss of $97.575 million for the same period in 2021, representing an increase of approximately 134%[166]. Research and Development - Research and development expenses for the six months ended June 30, 2022, totaled $167,212,000, a 40.2% increase from $119,232,000 in the same period of 2021[17]. - Research and development expenses for the three months ended June 30, 2022, were $85.5 million, an increase from $63.7 million for the same period in 2021[205]. - The company anticipates continued investment in research and development to drive future growth and innovation in precision oncology[11]. - The company expects that research and development expenses will continue to increase in absolute dollars as it innovates and develops additional products[197]. Assets and Liabilities - Total current assets decreased to $1,037,139,000 as of June 30, 2022, down from $1,114,126,000 at the end of 2021[14]. - Total liabilities as of June 30, 2022, were $1,534,650,000, slightly down from $1,559,494,000 at the end of 2021[14]. - The total stockholders' equity as of June 30, 2022, was $319,087 thousand, a decrease from $788,065 thousand as of June 30, 2021, indicating a decline of approximately 60%[24]. - The company had cash and cash equivalents of $215,169,000 as of June 30, 2022, a decrease from $492,202,000 at the end of 2021[14]. - The company had cash, cash equivalents, and marketable securities of approximately $1.2 billion as of June 30, 2022[178]. Investments and Acquisitions - The company completed the acquisition of Guardant Health AMEA, Inc. in June 2022, gaining full ownership of the joint venture previously held with SoftBank, enhancing its market presence in the AMEA region[2]. - The company completed the purchase of all shares held by SoftBank for $177.8 million in June 2022, gaining full control over operations in the Asia, Middle East, and Africa region[183]. - As of June 30, 2022, the company's non-marketable equity investments totaled $52.2 million, up from $39.4 million as of December 31, 2021, indicating a strategic focus on expanding its investment portfolio[3]. Stock-Based Compensation - The total stock-based compensation expense was $25.544 million for the three months ended, compared to $34.507 million in the same period of 2021, reflecting a decrease of approximately 26.5%[153]. - The total intrinsic value of options exercised was $2.0 million for the three months ended June 30, 2022, compared to $11.1 million for the same period in 2021, indicating a decrease of 82%[139]. - The weighted-average grant date fair value of options granted was $23.41 per share for the three months ended June 30, 2022, down from $81.79 per share in 2021, representing a decline of 71%[140]. - Future stock-based compensation for unvested options as of June 30, 2022, is estimated at $32.7 million, expected to be recognized over a weighted-average period of 2.9 years[140]. Operational Highlights - Guardant Health has launched several proprietary tests, including Guardant360 LDT and Guardant360 CDx, which are FDA-approved for tumor mutation profiling in solid tumors[1]. - The company is expanding into multi-cancer screening with its investigational next-generation Guardant SHIELD assay, which has shown high accuracy in detecting early-stage cancers[9]. - The Guardant360 CDx test received regulatory approval in Japan for identifying patients with advanced solid tumors who may benefit from specific cancer treatments[186]. - The company initiated a 1,000-patient prospective study for the Guardant Reveal test in October 2021, aimed at evaluating its performance in predicting cancer recurrence[186]. - A strategic partnership was signed with Adicon Holdings Limited in June 2022 to offer genomic profiling tests to biopharmaceutical companies in China[185]. Future Outlook - The company expects to recognize substantially all of the remaining transaction price allocated to performance obligations in the next 1-2 years[75]. - The company expects sales and marketing expenses to increase in absolute dollars as it expands its sales force and marketing activities[198]. - The company believes its existing cash and cash equivalents will be sufficient to fund operations for at least one year from the financial statement date, although it continues to incur losses[7].
Guardant Health (GH) Presents at the William Blair 42nd Annual Growth Stock Conference - Slideshow
2022-06-18 15:40
| --- | --- | |----------------------------------------------|-------| | | | | | | | | | | Transforming cancer care | | | William Blair Growth Conference June 7, 2022 | | Safe Harbor Certain statements in this presentation and the accompanying oral commentary are forward-looking statements within the meaning of federal securities laws. These statements relate to future events or Guardant Health, Inc. (the "Company")'s future results and involve known and unknown risks, uncertainties and other factors that m ...
Guardant Health(GH) - 2022 Q1 - Earnings Call Presentation
2022-05-06 03:55
Q1 2022 earnings Call May 5, 2022 Safe Harbor Certain statements in this presentation and the accompanying oral commentary are forward-looking statements within the meaning of federal securities laws. These statements relate to future events or Guardant Health, Inc. (the "Company")'s future results and involve known and unknown risks, uncertainties and other factors that may cause the actual results, levels of activity, performance or achievements of the Company or its industry to be materially different fr ...
Guardant Health(GH) - 2022 Q1 - Earnings Call Transcript
2022-05-06 03:50
Guardant Health, Inc. (NASDAQ:GH) Q1 2022 Earnings Conference Call May 5, 2022 4:30 PM ET Company Participants Alex Kleban - VP, IR Helmy Eltoukhy - Co-CEO AmirAli Talasaz - Co- CEO Mike Bell - CFO Conference Call Participants Puneet Souda - SVB Securities Dan Arias - Stifel Jack Meehan - Nephron Research Yih-Ming Tu - Morgan Stanley Derik De Bruin - Bank of America Kyle Mikson - Canaccord Mark Massaro - BTIG Max Masucci - Cowen Patrick Donnelly - Citi Julie Qin - JPMorgan David Delahunt - Goldman Sachs Bri ...