On May 11, 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 first quarter ended March 31, 2021 and provided a corporate update (Press release, Biodesix, MAY 11, 2021, View Source [SID1234579719]).
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!
"We were pleased with our strong operating and financial performance in the first quarter and believe we are off to a solid start in 2021," said Scott Hutton, Chief Executive Officer. "We are encouraged by the trends in our core lung diagnostic testing. Additionally, Biodesix continues to innovate as demonstrated through our announcement of two new products and we are well-positioned for the future."
First Quarter 2021 Financial Results
Successfully secured additional liquidity and deferred principal repayments through February 2024 by closing a new $30.0 million term loan and retiring the prior term loan for $25.9 million;
Total revenue of $28.9 million, an increase of 466% over first quarter 2020 and 7% over fourth quarter 2020;
COVID-19 testing revenue of $23.2 million, an increase of 8% over fourth quarter 2020;
Lung diagnostic revenue of $4.0 million, representing continued recovery and growth of 10% over first quarter 2020 and 8% over fourth quarter 2020;
Services revenue of $1.7 million, an increase of 12% over first quarter 2020 and 12% decline over fourth quarter 2020;
Gross profit of $10.6 million and gross margin percentage of 37%, both aligned with management expectations, primarily as a result of growth in COVID-19 testing;
Operating expenses (excluding direct costs and expenses) of $16.2 million, which includes an investment in the planned expansion of our salesforce, increased 36% over first quarter 2020 and 8% over fourth quarter 2020;
Non-cash stock compensation expense of $1.8 million, $0 and $3.7 million recognized during first quarter 2021, first quarter 2020 and fourth quarter 2020, respectively; and
Net loss of $7.0 million, an improvement of 28% over first quarter of 2020 and a 54% increase over fourth quarter 2020.
Business Highlights
Biodesix continues to make significant progress in lung diagnostics testing, including the addition of a new test to the lung cancer testing portfolio as well as new data that continues to support the value and utility of the Biodesix lung diagnostics portfolio. As a result of on-going progress, the Company was pleased to announce the following:
Plans to add a blood-based 52-gene next generation sequencing (NGS) test to the portfolio were announced in April 2021. The NGS test has unprecedented turnaround time of only 72-hours, according to data presented in a recent publication in Diagnostics. The NGS test will complement the improved 36-hour turnaround time that the GeneStrat ddPCR and VeriStrat tests currently offer, providing expanded coverage of 52-genes and broader molecular markers. The test will be used for advanced, late-stage, or recurrent cancer mutation detection in non-small cell lung cancer (NSCLC) and is expected to begin to be offered to physicians in the first half of 2022.
The issuance of two U.S. patents in April 2021 that enhance the Company’s ability to develop blood-based immunotherapy and other pipeline testing strategies for cancer patients.
Presentation of data from three studies at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April 2021, including data from VeriStrat and the Primary Immune Response (PIR) test that further demonstrate the utility of protein biomarker data from blood-based proteomic testing to support targeted and immunotherapy treatment strategies for NSCLC patients.
Beyond advancements in the lung diagnostic portfolio, the Company continued to expand and progress its partnerships and services related to COVID-19 testing, including the following:
In April 2021, announced a partnership with GenScript Biotech to conduct performance verification of the cPassTM SARS-CoV-2 Neutralization Antibody Detection test in our laboratory, with expected commercial launch in mid-year 2021. The test is the first and only surrogate neutralizing antibody test with FDA Emergency Use Authorization (EUA) to date and uses ELISA technology to qualitatively detect circulating neutralizing antibodies to the receptor binding domain (RBD) in the spike protein of SARS-CoV-2 that are produced in response to vaccination or previous SARS-CoV-2 infection.
In February 2021, announced a partnership with the Chicago Public Schools to provide antigen and Droplet Digital PCR (ddPCR) testing for Chicago Public School teachers and staff.
In January 2021, collaborated with the Purdue University Protect Purdue Health Center, to test students taking classes on the West Lafayette, Indiana Campus living off-campus during the Spring 2021 semester.
Conference call and webcast information
Management will host an investor conference call and webcast today, May 11, 2021 at 4:30 p.m. Eastern Time.