NEW YORK – Guardant Health reported after the close of the market on Wednesday that its fourth quarter 2020 revenues rose 25 percent year over year, driven by an increase in clinical testing volumes and revenue.
The Redwood City, California-based cancer genomics and early detection firm said its total revenues for the three months ended Dec. 31, 2020 were $78.3 million compared to $62.9 million in the same quarter of 2019, beating the $76.7 million that Wall Street analysts, on average, had predicted.
Precision oncology revenues for the quarter grew 13 percent to $64.7 million from $57.4 million in Q4 2019, driven by gains in clinical testing revenues of about 47 percent year over year. The company said it performed 17,353 clinical tests and 4,841 biopharmaceutical tests during the fourth quarter.
Development services revenue increased 148 percent to $13.6 million from $5.5 million in the year-ago quarter, primarily reflecting the timing of project-related milestones for the firm's companion diagnostic development programs.
The major milestone for Guardant leading up to the end of 2020 was the US Food and Drug Administration's approval of the IVD version of its flagship assay, Guardant360 CDx, for comprehensive cancer profiling across solid tumors and as a companion diagnostic for osimertinib (AstraZeneca's Tagrisso).
Guardant CEO Helmy Eltoukhy said during a call discussing the company's financial results that despite impacts from the pandemic resurgence at the end of last year, the company has been able to hold on to significant momentum from this September FDA approval.
"We were encouraged by the growth of not only G360 test orders but by the continued growth in the total number of oncologists ordering our tests per quarter, another record number in Q4," he said, adding that confidence has been further bolstered by the "strong recovery" the company is now seeing in 2021 compared to its low point of testing volume in December.
Looking forward, Guardant President AmirAli Talasaz said that although the company is pleased with progress in its pharma testing and CDx partnerships, the first half of this year is expected to feature a reduction in trial enrollment due to the ongoing impact of Covid-19.
According to the firm's CFO Michael Bell, Guardant expects this pandemic environment to result in sequentially lower revenue in the first quarter of 2021 compared to the fourth quarter of 2020. That said, "we expect revenue growth back above 30 percent by the end of the year," he said.
Talasaz added that the firm is still seeing significant interest in its companion diagnostic business following 2020's FDA approval, and it has submitted supplemental PMAs for its collaborations with both Janssen and Amgen.
Guardant's Q4 net loss attributable to its shareholders was $93.7 million, or $.94 per share, compared to a net loss of $25.2 million, or $.27 per share, in Q4 2019. Analysts were expecting a loss of $.57 per share for the recently completed quarter.
The firm's quarterly R&D costs rose about 56 percent year over year to $40.3 million from $25.9 million, while its SG&A expenses jumped 145 percent to $100.8 million from $41.2 million.
For full-year 2020, total revenues rose 34 percent to $286.7 million from $214.4 million in 2019, exceeding the analyst's average estimate of $284.8 million.
Precision oncology revenues for the year rose 31 percent to $236.3 million from $180.5 million, driven by increased clinical test rates and revenues. The company said it performed 63,254 clinical tests and 15,983 tests for biopharmaceutical research partners over the course of the year.
Its 2020 development services revenues were $50.4 million, up 49 percent from $33.9 million the year before, reflecting the advancement of existing collaboration agreements and the signing of new deals over the course of the year.
Guardant's net loss attributable to its shareholders for the year jumped to $253.8 million, or $2.60 per share, from $75.7 million, or $0.84 per share, in 2019. Analysts, on average, were expecting full-year losses of about $2.21 per share.
The firm's 2020 R&D costs rose about 74 percent to $149.9 million from $86.3 million, while its SG&A expenses went up 114 percent to $299.3 million from $139.7 in 2019.
Guardant ended the year with $833 million in cash and cash equivalents, and $961.9 million in short-term marketable securities.
For 2020, the company expects full-year revenues in the range of $360 million to $370 million.