NEW YORK – Biodesix said on Tuesday following the close of the market that its fourth quarter revenues leapt 227 percent year over year, primarily due to a jump in COVID-19 testing-related revenues.
For the three months ended Dec. 31, the Boulder, Colorado-based firm reported revenues of $27.0 million compared to $8.3 million in the same period the year before, at the high range of previously reported preliminary revenues and beating the Wall Street estimate of $15.5 million.
Biodesix posted $21.4 million in COVID-19 testing-related revenues for the recently completed quarter. On a conference call with analysts following the release of earnings, Biodesix CEO Scott Hutton said that COVID-19 testing revenue included revenue from the firm's Biodesix Worksafe Testing Program. The program uses Bio-Rad's SARS-CoV-2 Droplet Digital and Platelia SARS-CoV-2 Total Ab tests — which have both received US Food and Drug Administration Emergency Use Authorization — to provide rapid on-site testing for schools, athletics, and employers to identify presumptive positive cases of COVID-19, Hutton said.
Biodesix CFO Robin Cowie highlighted during the call that the firm's COVID-19 testing revenue helped offset the impact of the pandemic on its lung diagnostic and biopharma services. While Biodesix does not expect COVID-19 testing to be an ongoing core growth platform, Cowie said the revenue will allow the firm to invest in its cancer diagnostics and biopharma services.
Lung diagnostic revenues in the fourth quarter were $3.7 million, down about 20 percent from $4.6 million in the year-ago period. The firm attributed the drop to the shift of pulmonologists and other healthcare workers to SARS-CoV-2-related care.
Following the end of Q4, in January, the firm partnered with HiberCell to further develop an enzyme-linked immunosorbent assay (ELISA) as a companion diagnostic.
Biodesix's net loss in the fourth quarter improved to $4.5 million, or $0.25 per share, from a loss of $6.5 million, or $26.85 per share, in the prior year. Biodesix went public in the fall, and used approximately 18.4 million shares to calculate per-share loss in the recently completed quarter compared to 243,000 shares in Q4 2019.
The firm's R&D costs rose 24 percent to $3.1 million from $2.5 million a year ago. Meanwhile, selling, marketing, general, and administrative costs jumped 83 percent to $12.1 million from $6.6 million.
For full-year 2020, the firm's revenues were $45.6 million, up 85 percent from $24.6 million in 2019 and beating the analysts' estimate of $33.4 million.
Biodesix's net loss for the year was $31.4 million, or $6.48 per share, compared to $30.7 million, or $126.97 per share, in 2019. The firm used about 4.8 million shares to calculate per-share loss in Q4 2020 compared to 242,000 shares in the year-ago period.
Biodesix's full-year R&D expenses rose about 3 percent to $10.8 million from $10.5 million in 2019. The firm's selling, general, marketing and administrative expenses rose 14 percent to $34.9 million from $30.6 million in 2019.
Biodesix ended the year with $62.1 million in cash and cash equivalents.
Due to the impact of the pandemic, Biosdesix declined to provide full-year 2021 guidance. However, the firm expects that COVID-19-related revenues will be highest during the first quarter and will decline over the course of the year.
Sutton said that Biodesix's 2021 growth will be driven by multiple factors, including a doubling of its sales force who will contact pulmonologists and provide clinicians with personalized information to help direct lung cancer patient therapy.
Biodesix will continue to invest in its pipeline of lung cancer tests, including a blood-based proteomic pre-surgery test to identify early-stage lung cancer patients likely to recur. The firm is also developing its blood-based primary immune response proteomic test that will guide immunotherapy treatment decisions and spot patients likely to be rapid progressors on immunotherapy.
Sutton also noted that Biodesix has built an AI-based COVID-19 algorithm to help identify patients that are likely to require intervention, such as individuals needing treatment with ventilators or admission to ICUs.
Sutton said the firm expects to publish additional validation studies on the Nodify Lung and Biodesix Lung Reflex before commercially launching them in 2023.
In early morning trading on the Nasdaq, Biodesix's shares were up 5 percent at $22.88.