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Guardant Health (GH) Presents At 40th Annual J.P. Morgan Virtual Healthcare Conference
2022-01-24 17:11
Financial Performance & Growth - Guardant Health shows a strong Compound Annual Growth Rate (CAGR) of 59%[9] - The company's revenue increased from $91 million in 2018 to between $360 million and $370 million in 2021[9] - The company has $1.7 billion in cash, cash equivalents, and marketable securities as of September 30, 2021[10] Product Development & Clinical Trials - Guardant Health's ECLIPSE trial has reached its target enrollment[7, 32] - The company initiated the SHIELD lung study and enrolled the first patient[7] - The ORACLE study is evaluating Guardant Reveal to predict cancer recurrence after curative intent treatment, targeting ~1,000 individuals across 11 solid tumor types[7, 21, 22] - A next-generation Guardant SHIELD assay is under development, with a ~30x larger genomic footprint than the original panel[41] Market & Commercial Expansion - The company has partnerships with over 100 biopharma companies[8, 10, 47] - Over 250,000 tests have been ordered, and more than 11,000 oncologists are ordering Guardant Health's tests[7, 10] - The company is expanding internationally, with lab partners in the UK & Spain and regulatory approval being pursued in Japan[7] - The company has secured coverage for over 200 million lives[8] Technology & Innovation - Guardant Health is developing a "Smart Liquid Biopsy" with a nearly 100X larger genomic footprint than Guardant360 CDx, including genomic, epigenomic, and immune signatures, expected in 2022[28] - The company's technology integrates genomic and epigenomic ctDNA signals, increasing sensitivity by 1.3-2.5x[25] - Guardant Health's digital sequencing enables early detection with higher signal-to-noise ratio and lower sequencing cost[29] Screening and MRD Market Opportunity - The Minimal Residual Disease (MRD) market represents a $20B+ Total Addressable Market (TAM)[13, 24] - The therapy selection market is estimated at $6 billion, the MRD market at $10 billion, and the early-stage survivors market at $15 billion[26] - Blood-based screening is preferred by 64% of patients for CRC screening, compared to 36% for colonoscopy, FIT, or Cologuard[37]
Guardant Health(GH) - 2021 Q3 - Earnings Call Transcript
2021-11-05 02:05
Guardant Health, Inc. (NASDAQ:GH) Q3 2021 Earnings Conference Call November 4, 2021 4:30 PM ET Company Participants Carrie Mendivil - 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 Leerink Brian Weinstein - William Blair Derik De Bruin - Bank of America Jack Meehan - Nephron Matt Sykes - Goldman Sachs Patrick Donnelly - Citi Julia Qin - JPMorgan David Westenberg - ...
Guardant Health(GH) - 2021 Q3 - Quarterly Report
2021-11-03 16:00
For the quarterly period ended September 30, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 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 transition period from to Commission File Number: 001-38683 _____________________ GUARDANT HEALTH, INC. (Exact Name of Registrant as Sp ...
Guardant Health(GH) - 2021 Q2 - Earnings Call Transcript
2021-08-06 08:09
Guardant Health, Inc. (NASDAQ:GH) Q2 2021 Earnings Conference Call August 5, 2021 4:30 PM ET Company Participants Carrie Mendivil – Investor Relations Helmy Eltoukhy – Chief Executive Officer AmirAli Talasaz – President Mike Bell – Chief Financial Officer Conference Call Participants Julia Qin – JPMorgan Doug Schenkel – Cowen and Company Edmund Tu – Morgan Stanley Brian Weinstein – William Blair Juan Avendano – Bank of America Patrick Donnelly – Citi Dan Arias – Stifel Jack Meehan – Nephron Andrew Cooper – ...
Guardant Health(GH) - 2021 Q2 - Quarterly Report
2021-08-04 16:00
Financial Performance - Total revenue for the second quarter of 2021 was $92.1 million, a 39% increase from $66.3 million in the same period of 2020[18] - Precision oncology testing revenue reached $72.6 million, up 42% from $51.0 million year-over-year[18] - Net loss for the second quarter of 2021 was $97.6 million, compared to a net loss of $49.7 million in the second quarter of 2020[21] - The company reported a comprehensive loss of $98.4 million for the second quarter of 2021, compared to a comprehensive loss of $52.1 million in the same quarter of 2020[21] - The net loss for the three months ended June 30, 2021, was $97,575, compared to a net loss of $49,739 for the same period in 2020, indicating a year-over-year increase in losses[24] - The net loss for the six months ended June 30, 2021, was $204.93 million, compared to a net loss of $81.57 million for the same period in 2020, representing an increase of 151%[28] - The company generated total revenue of $170.8 million for the six months ended June 30, 2021, compared to $133.8 million for the same period in 2020, reflecting a 27.7% increase[190] Expenses - Research and development expenses increased to $63.7 million for the second quarter of 2021, a 75% rise from $36.3 million in the same quarter of 2020[18] - Stock-based compensation for the three months ended June 30, 2021, was $34,507, up from $25,815 in the same period of 2020[24] - The total stock-based compensation expense for the six months ended June 30, 2021, was $89.6 million, compared to $32.2 million for the same period in 2020[158] - Operating lease expenses for the three months ended June 30, 2021, were $6.9 million, compared to $1.9 million for the same period in 2020[124] - The total accrued expenses increased to $32.0 million as of June 30, 2021, up from $22.6 million at the end of 2020, reflecting a significant rise in accrued professional services and clinical trials[93] Assets and Liabilities - Total current assets as of June 30, 2021, were $1.89 billion, slightly up from $1.88 billion at the end of 2020[15] - Total liabilities increased to $1.44 billion as of June 30, 2021, compared to $916.2 million at the end of 2020[15] - Cash and cash equivalents were $938.6 million as of June 30, 2021, an increase from $833.0 million at the end of 2020[15] - As of June 30, 2021, total stockholders' equity was $788,065, an increase from $847,046 as of March 31, 2021, reflecting a net loss of $97,575 during the quarter[24] - The company had cash, cash equivalents, and marketable securities of $1.8 billion as of June 30, 2021[190] Revenue Recognition - Revenue from significant customer B represented 29% of total revenue for the three months ended June 30, 2021, compared to 23% for the same period in 2020[48] - Revenue recognized in the six months ended June 30, 2021, from deferred revenue was $6.4 million, including $3.0 million from development services under collaboration agreements[70] - Revenue from clinical tests for patients covered by Medicare represented approximately 44% of precision oncology revenue from clinical customers during the three months ended June 30, 2021[192] - Revenue from clinical tests covered by Medicare accounted for 42% of precision oncology revenue for the six months ended June 30, 2021, up from 36% in the same period of 2020[197] Joint Venture and Collaborations - The company has a 50% ownership interest in a joint venture with SoftBank, which has subsidiaries in Singapore and Japan[33] - The Joint Venture is expected to accelerate commercialization of the Company's products in Asia, the Middle East, and Africa[81] - The company formed a joint venture, Guardant Health AMEA, Inc., with SoftBank to accelerate commercialization of its products in Asia, the Middle East, and Africa[195] Stock and Equity - The company issued 88,832 shares upon the exercise of stock options and 60,898 shares under the employee stock purchase plan, contributing an additional $6,327 to additional paid-in capital[24] - The total number of common shares outstanding increased from 101,085,653 as of March 31, 2021, to 101,265,100 as of June 30, 2021[24] - The company has 13,939,220 shares reserved for potential future issuances as of June 30, 2021, compared to 11,344,620 shares as of December 31, 2020[142] Legal Matters - The company is involved in multiple legal proceedings, which may have a material adverse impact on its financial position if unsuccessful[128] - The company has ongoing patent disputes with Foundation Medicine, including multiple lawsuits filed in both the U.S. and Germany[132][134] - The company has settled a patent infringement lawsuit with Personal Genome Diagnostics, resulting in the dismissal of all related claims[137] Product Development and Market Expansion - The company launched Guardant Reveal in February 2021 for Stage II-III colorectal cancer and Guardant360 TissueNext in June 2021 for advanced cancer treatment[32] - The company launched Guardant360 TissueNext and Guardant360 Response in June 2021, expanding its product offerings for advanced cancer treatment[188] - The company initiated the ECLIPSE trial, aiming to recruit approximately 13,000 patients to evaluate the performance of the LUNAR-2 assay in detecting colorectal cancer[195] - The Guardant360 CDx test received ADLT status from CMS, allowing billing at the lowest available commercial rate for the first three quarters from April 1, 2021[195] Future Outlook - The company anticipates continued growth in precision oncology testing revenue driven by increased demand and market expansion efforts[14] - The company expects research and development expenses to continue increasing in absolute dollars as it innovates and develops additional products[204] - Sales and marketing expenses are anticipated to increase in absolute dollars as the company expands its sales force and marketing activities[206]
Guardant Health(GH) - 2021 Q1 - Earnings Call Transcript
2021-05-07 02:24
Start Time: 16:30 January 1, 0000 4:57 PM ET Guardant Health, Inc. (NASDAQ:GH) Q1 2021 Earnings Conference Call May 06, 2021, 16:30 PM ET Company Participants Helmy Eltoukhy - CEO AmirAli Talasaz - President and COO Mike Bell - CFO Carrie Mendivil - IR Conference Call Participants Operator Thank you for standing by, and welcome to the Guardant Health Q1 2021 Earnings Call. All lines are currently in a listen-only mode. After the speakers' presentation, there will a question-and-answer session. [Operator Ins ...
Guardant Health(GH) - 2021 Q1 - Quarterly Report
2021-05-05 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 March 31, 2021 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 Specif ...
Guardant Health(GH) - 2020 Q4 - Earnings Call Transcript
2021-02-25 05:46
Guardant Health, Inc. (NASDAQ:GH) Q4 2020 Earnings Conference Call February 24, 2021 5:00 PM ET Company Participants Carrie Mendivil - Investor Relations Helmy Eltoukhy - Co-Founder & Chief Executive Officer AmirAli Talasaz - Co-Founder & President Mike Bell - Chief Financial Officer Conference Call Participants Brian Weinstein - William Blair Tycho Peterson - JPMorgan Doug Schenkel - Cowen Puneet Souda - SVB Leerink Tejas Savant - Morgan Stanley Derik de Bruin - Bank of America Patrick Donnelly - Citi Dan ...
Guardant Health(GH) - 2020 Q4 - Annual Report
2021-02-24 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 _____________________ FORM 10-K _____________________ (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2020 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 i ...
Guardant Health(GH) - 2020 Q3 - Earnings Call Transcript
2020-11-06 07:07
Financial Data and Key Metrics Changes - Revenue for Q3 2020 totaled $74.6 million, up 23% from $60.8 million in Q3 2019, driven by increased precision oncology testing revenues and higher development services revenue [36][10][44] - Gross profit for Q3 2020 was $53.4 million, compared to $42.3 million in the same period of the prior year, with a gross margin of 72% compared to 70% in Q3 2019 [45] - Net loss attributable to common stockholders was $77.7 million or $0.78 per share for Q3 2020, compared to a net loss of $12.8 million or $0.14 per share in Q3 2019 [49] Business Line Data and Key Metrics Changes - Clinical precision oncology revenue for Q3 was $60.4 million, with clinical tests contributing $48.4 million and biopharmaceutical tests contributing $12 million [36][37] - Clinical precision oncology volume totaled 16,950 tests, up 28% year-over-year and up 24% from Q2 2020 [38] - Biopharmaceutical tests volume totaled 3,071 tests, down 42% year-over-year but up 9% from Q2 2020 [43] Market Data and Key Metrics Changes - The FDA approval of Guardant360 CDx is expected to enhance adoption of comprehensive genomic profiling in solid tumor cancer patients [12][14] - The company anticipates that the FDA approval will strengthen reimbursement discussions with private payers and improve Medicare pricing [15][75] Company Strategy and Development Direction - The company aims to expand its liquid biopsy platform to address the continuum of cancer care, from screening to therapy selection [20][22] - The LUNAR program is focused on colorectal cancer as a starting point for expanding monitoring and screening for multiple cancer types [22][31] - The company is committed to innovation, launching a next-generation version of Guardant360 to include additional biomarkers [16][17] Management's Comments on Operating Environment and Future Outlook - Management noted that the resurgence of COVID-19 cases may adversely affect clinical volumes, with expectations for modest growth in Q4 2020 [11][56] - The company is optimistic about the growth of its Biopharma business and expects development services revenue to remain strong [57] - Management expressed confidence in the potential of liquid biopsy to transform oncology and emphasized the importance of FDA approval in driving adoption [21][90] Other Important Information - The company ended Q3 2020 with over $1 billion in cash, cash equivalents, and marketable securities [49] - The company has not reinstated financial guidance due to the unpredictable impact of COVID-19 on the oncology space [54] Q&A Session Summary Question: Clinical volumes and COVID-19 impact - Management acknowledged that while clinical volumes recovered quickly, the resurgence of COVID-19 poses challenges, particularly for in-person patient visits [63][64] Question: G360 LDT regulatory pathway - Management indicated that the FDA approval of Guardant360 CDx provides a framework for the LDT, enhancing its market position [66][67] Question: Multi-cancer screening opportunity - Management believes that the core platform technology can be adapted for multiple cancer types, starting with colorectal cancer [70][71] Question: Private payer coverage expansion post-FDA approval - Management reported positive momentum in discussions with private payers and expects improved ASP due to broader Medicare coverage [75][76] Question: ECLIPSE study enrollment timeline - Management confirmed that they are on track to complete enrollment for the ECLIPSE study within the originally stated 24-month timeline [82] Question: Comparison of LUNAR-1 with other methods - Management emphasized the unique approach of LUNAR-1, which integrates genomic and epigenomic data, providing a comprehensive solution for residual disease detection [101][102]