On December 10, 2020 Biodesix, Inc. a leading data-driven diagnostic solutions company with a focus in lung disease, reported financial and operating results for the third quarter ended September 30, 2020 and provided a corporate update (Press release, Biodesix, DEC 10, 2020, View Source [SID1234572611]).

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Third Quarter 2020 and Recent Highlights

Generated record quarterly revenue of $9.2 million for the third quarter ended September 30, 2020.
Completed initial public offering (IPO) that raised net proceeds of approximately $63 million after deducting offering costs, underwriting discounts and commissions.
Announced a strategic partnership with the Big Ten Conference whereby Biodesix is conducting ddPCR COVID-19 validation testing and managing the onsite testing of rapid antigen SARS-CoV-2 testing for all student-athletes and staff personnel involved in close contact sports competition.
Published an extended analysis of data from the company’s Nodify XL2 lung nodule test in the American College of Chest Physicians (CHEST) Journal. The data demonstrate that all nodules in the study group that were established as benign after one year remained benign after two years, the guideline-recommended surveillance period to radiologically confirm a benign diagnosis.
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 tests.
"We recently achieved a very significant milestone with our IPO and transition to a public company," stated Scott Hutton, Chief Executive Officer of Biodesix. "With the proceeds from the offering, we plan to continue to market our suite of commercially available diagnostic tests, including our Biodesix Lung Reflex and Nodify Lung testing strategies, in addition to our COVID-19 testing, while also investing in the discovery, development, and validation of innovative new tests leveraging our proprietary AI-driven discovery platform.

"We continue to monitor the COVID-19 pandemic carefully in light of the recent surge in case counts around the country, and we are pleased to be able to play an important part in the fight against this dangerous virus through our WorkSafe testing program. To this point, our lung disease-focused core business continues to perform well even while healthcare facilities devote time and resources to combat COVID-19 and travel restrictions affect our commercial efforts. We believe this is a testament to the valuable clinical information that our tests provide along critical points of the lung disease care continuum," concluded Mr. Hutton.

Financial Results

Revenue. Revenue for the three months ended September 30, 2020 was $9.2 million, as compared to $3.9 million for the comparable period in 2019, an increase of 133%. This increase was due to $5.5 million of revenue from our two COVID-19 diagnostic tests, partially offset by a modest decline in our non-COVID-19 diagnostic test volumes of $0.7 million as health care practitioners, including pulmonologists, were increasingly diverted to pandemic-related care. In addition, company sales efforts continued to be impacted by travel and other COVID-19 pandemic related restrictions. Revenue for the nine months ended September 30, 2020 was $18.5 million, as compared to $16.3 million for the comparable period in 2019, an increase of 14%.

Direct costs and expenses. Direct costs and expenses for the three months ended September 30, 2020 were $3.9 million, as compared to $1.5 million for the comparable period of 2019, an increase of 159%. Direct costs and expenses for the nine months ended September 30, 2020 were $7.3 million compared to $4.2 million for the nine months ended September 30, 2019, an increase of 73%. The increase in costs were primarily driven by the release of the company’s Nodify CDT test and its COVID-19 testing program in 2020.

Research and development. Research and development expenses for the three months ended September 30, 2020 were $2.7 million, as compared to $2.4 million for the comparable period in 2019, an increase of 15%. Research and development expenses for the nine months ended September 30, 2020 were $7.7 million, as compared to $8.0 million for the comparable period in 2019, a decrease of 3%.

Sales, marketing, general and administrative. Sales, marketing, general and administrative expenses for the three months ended September 30, 2020 were $7.9 million, as compared to $8.2 million for the comparable period in 2019, a decrease of 4%. Sales, marketing, general and administrative expenses for the nine months ended September 30, 2020 were $22.8 million, as compared to $24.1 million for the comparable period in 2019, a decrease of 5%. The decrease was driven by reductions in travel and related expenses as the COVID-19 pandemic reduced or eliminated the travel and related expenses.

Operating loss. Operating loss for the three months ended September 30, 2020 was $6.2 million, as compared to an operating loss of $9.0 million for the comparable period in 2019, a decrease of 31%. Operating loss for the nine months ended September 30, 2020 was $20.3 million, as compared to an operating loss of $23.2 million for the comparable period in 2019, a decrease of 13%. The decrease was due in part to higher revenue in the third quarter of 2020 as compared to the third quarter of 2019.

Net loss. Net loss for the three months ended September 30, 2020 was $8.9 million, as compared to $9.6 million for the comparable period in 2019, a decrease of 8%. Net loss for the nine months ended September 30, 2020 was $26.8 million, as compared to $24.2 million for the comparable period in 2019, an increase of 11%.

Cash and cash equivalents. As of September 30, 2020, the company held cash and cash equivalents of $6.3 million, as compared to $5.3 million as of December 31, 2019. Subsequent to the end of the third quarter, the company completed a successful initial public offering that raised net proceeds of approximately $63 million. As a result of the completion of the initial public offering, the company estimates that it has sufficient cash resources to meet its cash obligations through at least the next 12 months.