On March 14, 2022 Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic solutions company with a focus in lung disease, reported its financial and operating results for the fourth quarter and year ended December 31, 2021 (fiscal 2021) and provided a corporate update (Press release, Biodesix, MAR 14, 2022, View Source [SID1234610063]).

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"Despite the ongoing challenges caused by the global pandemic, the fourth quarter and fiscal 2021 were very productive." said Scott Hutton, CEO of Biodesix. "Most notably, we successfully executed on our revenue growth strategy by doubling our direct, dedicated sales force, which significantly contributed to our core lung diagnostic revenue growth of 48% and 49% for fourth quarter and fiscal 2021, respectively. We further executed on our third quarter 2021 commitment to a commercial launch of our GeneStrat NGS test in January 2022. From the clinical data standpoint, we presented new data during the fourth quarter of 2021 on our NodifyXL2 test from the prospective ORACLE study, and on our VeriStrat test from the prospective INSIGHT study. This new data truly underscores the value of both products in the real-world setting and adds to the body of evidence. We continue to be excited about the trajectory of the business, despite the challenges from the ongoing pandemic, which gives us confidence heading into 2022."

Fourth Quarter and Full Year 2021 Financial Results

•Total revenue of $7.2 million and $54.5 million for the fourth quarter and fiscal 2021, respectively,
▪Continued lung diagnostic year over year growth despite COVID-19 variant surges;
•Core lung diagnostic revenue of $5.4 million and $18.7 million for the fourth quarter and fiscal 2021, respectively, an increase of 48% and 49% over the respective prior year comparable periods;
▪Nodify nodule management tests and sales force expansion continue to drive lung diagnostic growth;
•BioPharma Services revenue of $1.4 million and $5.6 million for the fourth quarter and fiscal 2021, respectively, a decrease of 29% and increase 20% over the respective prior year comparable periods;
•COVID-19 testing revenue of $0.4 million and $30.2 million for the fourth quarter and fiscal 2021, respectively, a decrease of 98% and increase 7% over the respective comparable periods in 2020;
▪Decline over the fourth quarter of 2020 commensurate with the shift away from lab-based testing and towards point-of-care and at-home rapid antigen testing during much of the back half of 2021;

•Fourth quarter 2021 gross margin of $4.7 million or 65% as a percentage of revenue as compared to 46% in the compaable prior year period primarily driven by the mix shift of sales to higher-margin core lung diagnostics and away from lower-margin COVID-19 testing;
•Operating expenses (excluding direct costs and expenses) of $16.4 million and $64.9 million for the fourth quarter and fiscal 2021, an increase of 9% and 40% over the comparable prior year periods;
▪Doubled the size of lung focused direct and dedicated sales force in 2021;
▪Includes non-cash stock compensation expense of $1.3 million and $4.9 million during fourth quarter and fiscal 2021, respectively;
•Net loss of $13.3 million and $43.2 million for the fourth quarter and fiscal 2021, respectively, an increase of 193% and 38% over the respective comparable periods in 2020;
•Cash and cash equivalents of $32.7 million, inclusive of a fourth quarter 2021 equity capital issuance of $15.7 million in net proceeds and the prepayment of $20 million of the 2021 Term Loan;
▪Announced a Common Stock Purchase Agreement for up to $50 million.
2022 Financial Outlook

The Company anticipates generating between $37.5 million to $39.5 million in total revenue in 2022.

Conference call and webcast information

Management will host an investor conference call and webcast today, March 14, 2022 at 8:30 a.m. Eastern Time.

An archived replay of the webcast will be available on the Company’s website for a period of 90 days.

For a full list of Biodesix’s press releases and webinars, please visit Biodesix.com.