On March 16, 2021 Biodesix, Inc. (NASDAQ: BDSX) a leading data-driven diagnostic solutions company with a focus in lung disease, reported financial and operating results for the fourth quarter and full year ended December 31, 2020 and provided a corporate update (Press release, Biodesix, MAR 16, 2021, View Source [SID1234576725]).
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"We had a very productive fiscal year and fourth quarter highlighted by strong revenue growth resulting from our ability to shift gears and offer COVID-19 testing services to assist the nation in the midst of a global pandemic," stated Scott Hutton, Chief Executive Officer of Biodesix. "During this time, we also maintained our focus on the core strategic business of lung diagnostic testing and biopharma services and expect strong growth in 2021. Overall, 2020 was a transformative year for Biodesix and we are excited about the growth of our commercial organization, expansion of our clinical pipeline, and new clinical data, to quickly and positively impact the lives of patients in 2021."
Full Year and Fourth Quarter 2020 Financial Results
Successful initial public offering (IPO) raising net proceeds of $63.8 million;
Record annual revenue of $45.6 million, an increase of 86% over 2019 annual revenue;
Fourth quarter revenue of $27.0 million, an increase of 194% and 227%, respectively, over the third quarter 2020 and fourth quarter 2019;
Fourth quarter COVID-19 testing revenue of $21.4 million, a 287% improvement over third quarter 2020;
Fourth quarter lung diagnostic revenue of $3.7 million, a 22% improvement and 20% decline, respectively, over third quarter 2020 and fourth quarter 2019;
Fourth quarter 2020 services revenue of $1.9 million, a 198% improvement and 48% decline, respectively, over third quarter 2020 and fourth quarter 2019;
Fourth quarter gross profit of $12.4 million, a 133% and 92% increase, respectively, over third quarter 2020 and fourth quarter 2019;
Annual non-cash stock compensation expense of $3.7 million as compared to $0.2 million in 2019;
Strengthen balance sheet with $62.1 million of cash and cash equivalents as of December 31, 2020, an increase of $56.8 million over the comparable prior year period.
Business Highlights
As part of the Biodesix data-driven approach, the company continues to build strong clinical evidence to establish the value and utility of the Biodesix lung diagnostics portfolio.
Published an extended analysis of data from the company’s Nodify XL2 lung nodule test in the American College of Chest Physicians (CHEST 2020) Journal demonstrating that all nodules in the study group that were established as benign after one year remained benign after two years.
Presented data from three studies at the American College of Chest Physicians (CHEST 2020) Annual Meeting highlighting the clinical value of the company’s Nodify XL2 and Nodify CDT lung nodule risk assessment suite and the utility of Nodify Lung Risk Assessment tests in helping physicians to reduce unnecessary procedures on benign nodules and delays in diagnosis of malignant nodules.
Initiated recruitment in the Nodify XL2 Classifier Prospective Study in Low to Moderate Risk Lung Nodules (ALTITUDE) with the intent to assess how clinical decision making can be impacted by the introduction of Nodify Lung test results into risk assessment.
Showcased data from multiple studies at the International Association for the Study of Lung Cancer (IASLC) World Conference on Lung Cancer (WCLC) demonstrating individual patient’s immune profile capabilities in providing information to support treatment decisions for patients diagnosed with advanced non-small cell lung cancer (NSCLC).
Announced collaboration with HiberCell to further the development of an enzyme-linked immunosorbent assay (ELISA) as a companion diagnostic in future registration trials in breast cancer for Imprime PGG programs.
Announced publication of a peer-reviewed study supporting its patented blood collection device (BCD). The device is designed to streamline whole blood specimen collection and transportation to the laboratory while delivering diagnostic test results that are equivalent to traditional methods.
In addition to the significant accomplishments associated with our lung diagnostic advances, the Company continued to advance their partnerships and services related to COVID-19.
Announced strategic partnerships with both Purdue University and the Chicago Public School System for COVID-19 testing to safely reopen schools.
Published a paper demonstrating a new AI-based algorithm that can rapidly and accurately help physicians predict risk of severe outcomes for patients with COVID-19 infection utilizing readily available patient data collected upon hospital admission.
"During the fourth quarter, we continued to add to the growing body of published evidence demonstrating the value of the clinical information delivered by our suite of commercially available lung disease diagnostic tests," said Hutton. "Looking ahead, we are cautiously optimistic that a more normalized business environment will reemerge later this year, setting the stage for more robust growth in our core lung diagnostic business. We expect modest gross margin percentage expansion for 2021 as compared to 2020 as we continue to experience near-term strength in our COVID-19 diagnostic testing, which on average has lower overall gross margin percentages than our lung diagnostic testing services. We were particularly pleased to show revenue growth in the fourth quarter over the third quarter in our lung diagnostic testing services and biopharma services even while COVID-19 cases surged, and healthcare practitioners and facilities remained focused on fighting the pandemic."
"At the same time, our COVID-19 testing services delivered strong revenue growth, as evidenced by our strategic partnerships that benefited our fourth quarter 2020. In addition, we continue to expand the reach of our COVID-19 testing services with our recently announced partnership with Purdue University and the Chicago Public School System, one of the largest in the country, in an effort to safely reopen schools for in-person learning."
Conference call and webcast information
Management will host an investor conference call and webcast today, March 16, 2021 at 4:30 p.m. Eastern Time.
An archived replay of the webcast will be available on the company’s website for a period of 90 days.