On February 24, 2020 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood tests, vast data sets and advanced analytics, reported financial results for the fourth quarter and full year ended December 31, 2019 (Press release, Guardant Health, FEB 24, 2020, View Source [SID1234554653]).
Recent Highlights
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
Revenue of $62.9 million for the fourth quarter and $214.4 million for the full year of 2019, representing 91% and 137% increases, respectively, over the corresponding periods of 2018
Received expanded Medicare local coverage determination from Palmetto GBA, making Guardant360 assay the first and only liquid biopsy to be broadly covered for use across the vast majority of advanced solid tumors
Initiated the NRG-GI005 COBRA study to validate the clinical utility of LUNAR-1 assay as a diagnostic biomarker for selecting which patients with stage II colon cancer could benefit from adjuvant chemotherapy
Entered into a strategic collaboration with Amgen to develop Guardant360 assay as a blood-based companion diagnostic test for AMG 510, an investigational oral therapy that inhibits KRAS G12C mutant protein
"2019 was a transformational year for Guardant. We made incredible progress across our entire business and rapidly increased our revenue – growing more than 100 percent over 2018," said Helmy Eltoukhy, PhD, co-founder and CEO. "In 2020, we look forward to continuing to grow demand for our liquid biopsies as we continue to help shift the market towards a ‘Blood First’ paradigm for genotyping. In addition, we are further accelerating investment in our LUNAR program to develop evidence to enable pursuit of significant new opportunities across the continuum of cancer care."
Fourth Quarter 2019 Financial Results
Revenue was $62.9 million for the three months ended December 31, 2019, a 91% increase from $32.9 million for the three months ended December 31, 2018. Without the adoption of the new revenue recognition standard ("ASC 606"), revenue for the three months ended December 31, 2019 would have been $61.6 million, an 87% increase over the corresponding prior year period. Precision oncology revenue increased 104% driven primarily by higher testing volume. There were 15,270 clinical tests and 6,316 biopharmaceutical tests performed during the fourth quarter of 2019. Development services revenue increased 15% primarily from new projects in 2019 related to companion diagnostic development and regulatory approval services for biopharmaceutical customers. Total revenue for the three months ended December 31, 2019 included $1.3 million of payments received in that quarter from successful appeals of payers’ denials of reimbursement for samples processed in 2018. Given the age of the samples associated with these successful appeals, the company does not believe this appeals revenue is indicative of results in the ordinary course of its operations.
Gross profit, or total revenue less cost of precision oncology testing and cost of development services, was $41.1 million for the fourth quarter of 2019, an increase of $22.1 million from $18.9 million for the corresponding prior year period. Gross margin, or gross profit divided by total revenue, was 65.3%, as compared to 57.6% for the corresponding prior year period.
Operating expenses were $67.0 million for the fourth quarter of 2019, as compared to $46.3 million for the corresponding prior year period, an increase of 45%.
Net loss attributable to Guardant Health, Inc. common stockholders was $25.2 million for the fourth quarter of 2019, as compared to $25.1 million for the corresponding prior year period. Net loss per share attributable to Guardant Health, Inc. common stockholders was $0.27 for the fourth quarter of 2019, as compared to $0.30 for the corresponding period of the prior year.
Full Year 2019 Financial Results
Revenue for the year ended December 31, 2019 was $214.4 million, a 137% increase from $90.6 million for the year ended December 31, 2018. Without the adoption of ASC 606, revenue for the full year ended December 31, 2019 would have been $214.0 million, a 136% increase over the prior year. Precision oncology revenue increased 130% driven by higher testing volume and increased revenue per test. There were 49,926 clinical tests and 20,643 biopharmaceutical tests performed during 2019. Development services revenue increased 177% primarily from new projects in 2019 related to companion diagnostic development and regulatory approval services for biopharmaceutical customers. Total revenue for the year ended December 31, 2019 included $6.8 million of payments received during that year from successful appeals of payers’ denials of reimbursement for samples processed in 2018. Given the age of the samples associated with these successful appeals, the company does not believe this appeals revenue is indicative of results in the ordinary course of its operations.
1
guardantlogoa01.gif
Gross profit was $143.7 million for the year ended December 31, 2019, an increase of $96.2 million from $47.4 million for the year ended December 31, 2018. Gross margin was 67.0% for the year ended December 31, 2019, as compared to 52.3% for the year ended December 31, 2018.
Operating expenses were $226.0 million for the year ended December 31, 2019, as compared to $140.4 million for the year ended December 31, 2018, an increase of 61%.
Net loss attributable to Guardant Health, Inc. common stockholders was $75.7 million for the year ended December 31, 2019, as compared to $85.1 million for the year ended December 31, 2018. Net loss per share attributable to Guardant Health, Inc. common stockholders was $0.84 for the year ended December 31, 2019, as compared to $2.80 for the year ended December 31, 2018.
Cash, cash equivalents and marketable securities were $791.6 million as of December 31, 2019.
Guardant Health adopted ASC 606 effective January 1, 2019, which primarily impacted the company’s recognition of revenue related to patient claims paid by third-party commercial and governmental payors. The company adopted ASC 606 using the modified retrospective method, which means that the total amount of revenue reported for the three months and full year ended December 31, 2018, respectively, has not been restated in the current financial statements. Instead, the accumulated difference resulting from applying the new revenue standard to all contracts that were not completed as of adoption was recorded to accumulated deficit as of January 1, 2019.
2020 Financial Guidance
Guardant Health expects full year 2020 revenue to be in the range of $275.0 million to $285.0 million, representing 31% growth over the full year 2019 at the midpoint of the range. Net loss is expected to be in the range of $155.0 million to $160.0 million in 2020.
CFO Transition
Guardant Health also announced that its Chief Financial Officer, Derek Bertocci, is retiring during the second quarter of 2020. He will continue to serve in his current role until a successor is hired and plans to remain at Guardant Health and support the company during this transition.
"My time at Guardant has been a true privilege and I am honored to have worked alongside such an amazing team," said Mr. Bertocci "I believe deeply in Guardant’s vision and look forward to seeing Helmy, AmirAli and the entire team achieve even greater success in the years to come."
"Derek’s leadership, business acumen, work ethic and values have been instrumental to Guardant’s growth for over almost 4 years," said Dr. Eltoukhy. "On behalf of our entire management team and board of directors, I want to thank Derek for his contributions. We have a strong bench of talent in our finance and accounting organization and look forward to welcoming a new CFO in the coming months."
Webcast and Conference Call Information
Guardant Health will host a conference call to discuss the fourth quarter and full year 2019 financial results after market close on Monday, February 24, 2020 at 4:30 PM Eastern Time. The conference call can be accessed live over the phone (866) 417-5537 for U.S. callers or (409) 217-8233 for international callers (Conference ID: 8657963). The webcast can be accessed at View Source