Biodesix(BDSX) - 2022 Q4 - Annual Report

Financial Performance - The company reported revenues of $38.2 million for the year ended December 31, 2022, a decrease of 30% from$ 54.5 million in 2021, representing a change of $16.3 million[511]. - The net loss for the year was$ 65.4 million, an increase of 52% from a net loss of $43.2 million in 2021[511]. - Total revenue for Q4 2022 was$ 9.6 million, a 33% increase, while full-year revenue was $38.2 million, a 30% decrease compared to 2021[532]. - The company recorded a net loss of$ 20.3 million for Q4 2022, a 53% increase, and $65.4 million for the full year, a 52% increase compared to 2021[532]. - The company has incurred significant losses since inception and has funded operations mainly through the sale of common stock and convertible preferred stock, as well as revenue from diagnostic testing services[549]. Expenses and Costs - Direct costs and expenses decreased by 54% to$ 14.2 million in 2022 from $30.5 million in 2021, while research and development expenses increased by 2% to$ 13.1 million[511]. - Sales, marketing, general and administrative expenses rose by 22% to $61.5 million in 2022 compared to$ 50.5 million in 2021[511]. - Operating expenses for Q4 2022 were $20.2 million, a 23% increase, and$ 74.6 million for the full year, a 15% increase, driven by growth in core lung diagnostic revenue[532]. - Research and development expenses increased by $0.3 million or 2% for the year ended December 31, 2022, primarily due to higher clinical trial costs[542]. Cash and Financing - The company had cash and cash equivalents of$ 43.1 million as of December 31, 2022, up from $32.7 million in 2021[500]. - Cash and cash equivalents stood at$ 43.1 million, including $65.7 million in net proceeds from debt and equity offerings during Q4 2022[532]. - The company raised approximately$ 70.7 million in gross proceeds from various financing transactions, with $23.9 million used to retire outstanding debt and$ 42.0 million allocated for commercial expansion, product pipeline support, and general corporate purposes[548]. - The company plans to raise additional funding through equity or debt securities, which may dilute existing stockholders' ownership[549]. Revenue Sources and Trends - COVID-19 testing revenue declined to $5.2 million for the full year 2022, an 83% decrease, reflecting reduced demand due to increased vaccination rates and at-home testing availability[541]. - Core lung diagnostic revenue reached$ 8.2 million in Q4 2022, a 51% increase, and $29.3 million for the full year, a 57% increase driven by higher adoption of Nodify tests[532]. - The company experienced a decline in COVID-19 testing revenue after a peak in Q1 2021, primarily due to contract expirations and increased vaccination rates[547]. - The average selling price for biopharmaceutical sample testing is significantly higher than for clinical tests, affecting revenue dynamics[530]. Strategic Initiatives and Partnerships - The company has partnerships for COVID-19 testing and has managed onsite testing for athletic competitions, indicating ongoing market engagement[499]. - The company anticipates leveraging its scientific development and laboratory operations expertise for rapid growth in the future[499]. - The company commercialized five diagnostic tests for lung disease, all of which have Medicare coverage, significantly impacting revenue potential[527]. - The company has commercialized the Biodesix WorkSafe™ testing program in response to the COVID-19 pandemic, showcasing adaptability to market needs[528]. - The company signed four private payer commercial policies covering the Nodify XL2 test, adding approximately 4.5 million covered lives[531]. Operational Adjustments - The company is in discussions to extend its lease agreement for office and laboratory space in De Soto, Kansas, indicating ongoing operational adjustments[520]. - The company recorded unfavorable changes in net working capital of$ 9.0 million, primarily due to a $5.0 million refundable deposit related to the CVP Lease[551]. Technology and Innovation - The company leverages a proprietary AI platform, Diagnostic Cortex®, to enhance diagnostic test development, indicating a strong focus on technology integration[527]. - The company employs a multi-omic approach, utilizing genomics, transcriptomics, proteomics, and radiomics to improve diagnostic accuracy and patient outcomes[527]. - The GeneStrat targeted tumor profiling test and the VeriStrat immune profiling test now have a turnaround time of two business days, improved from three business days, enhancing service efficiency[528]. Market Access and Coverage - On June 7, 2022, the company announced that the Nodify CDT lung nodule test received coverage from WPS Government Health Administrators, expanding reimbursement for its tests[530]. - The U.S. Department of Veterans Affairs awarded a Federal Supply Schedule Contract for the company's entire portfolio of lung cancer diagnostic tests, increasing market access[530]. Future Outlook - The company expects sales and marketing expenses to increase in dollars as it expands its sales force and marketing activities, although these expenses are expected to decrease as a percentage of revenue in the long term[509]. - The company has seen recovery in lung diagnostic testing revenue during 2022 as healthcare practitioners returned to pre-pandemic care levels, although variability remains compared to pre-pandemic levels[547]. - The company is required to evaluate its ability to continue as a going concern, with substantial doubt raised about meeting financial covenants under its existing loan agreement in the next twelve months[549].