On March 6, 2023 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, 2022 (fiscal 2022) and provided a corporate update (Press release, Biodesix, MAR 6, 2023, View Source [SID1234628165]).

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"It has been a productive year for Biodesix, and I am extremely proud of our team’s performance. 2022 saw a significant increase in adoption of our core lung diagnostics business, growing test volume by 54% and revenue 57% year over year. In addition, we continued to produce compelling clinical utility data, expand reimbursement coverage including Medicare coverage of our Nodify CDT test and new private coverage policies for our Nodify XL2 test," said Scott Hutton, CEO of Biodesix. "Our strong performance and positive momentum gives us continued confidence for 2023."

Fourth Quarter and Full Year 2022 Financial Results

Total revenue of $9.6 million and $38.2 million for the fourth quarter and fiscal 2022, respectively, an increase of 33% and decrease of 30% over the respective prior year comparable periods;
Continued growth in core lung diagnostic sales, offset by the expected year-over-year decline in COVID-19 revenue due to the decrease in testing across the year.
Core lung diagnostic revenue of $8.2 million and $29.3 million for the fourth quarter and fiscal 2022, respectively, an increase of 51% and 57% over the respective prior year comparable periods;
Strong year-over-year performance in core lung diagnostics primarily driven by the increased adoption of Nodify Lung nodule management tests and, the highest total tests delivered in Company history.
COVID-19 testing revenue declined to an immaterial amount for the fourth quarter and $5.2 million for fiscal 2022, a decrease of 96% and 83% over the respective prior year comparable periods;
Commensurate with prior guidance resulting from the increase in COVID-19 vaccination rates across the U.S. and the adoption and availability of at-home testing, including the expiration of our most significant testing contracts.
Biopharma Services revenue of $1.4 million and $3.7 million for the fourth quarter and fiscal 2022, respectively, a decrease of 1% and 34% over the respective prior year comparable periods;
Clinical trial enrollment and shipping logistics continue to recover but are still impacting timelines for existing and new agreements;
Entering 2023 with highest dollars under contract in Company history, including both prospective and retrospective studies.
Gross margin was $6.3 million or 66% and $24.1 million or 63% for the fourth quarter and fiscal 2022, respectively, as a percentage of revenue compared to 65% and 44% in the comparable prior year periods, 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 $20.2 million and $74.6 million for the fourth quarter and fiscal 2022, an increase of 23% and 15% over the respective prior year comparable periods;
Increase in operating expenses is primarily from increased sales and marketing expense from the hiring of new sales reps, increased travel-related costs as access to physicians returned to pre-pandemic levels, and increases in other non-employee related costs all resulting from year-over-year growth in core lung diagnostic revenue;
Includes non-cash stock compensation expense of $2.1 million and $6.0 million during fourth quarter and fiscal 2022, respectively.
Net loss of $20.3 million and $65.4 million for the fourth quarter and fiscal 2022, respectively, an increase of 53% and 52% over the respective prior year comparable periods;
Includes loss on debt extinguishment and modification of $4.0 million and $7.0 million in the fourth quarter and fiscal 2022, respectively;
Fiscal 2021 included gain on debt extinguishment and modification of $2.3 million.
Cash and cash equivalents of $43.1 million as of December 31, 2022;
Raised $65.7 million of net proceeds during the quarter through debt and equity offerings and utilized $23.9 million to extinguish outstanding debt.
2023 Financial Outlook

The Company anticipates generating between $52 million to $55 million in total revenue in 2023;
Guidance represents anticipated 36-44% growth over 2022 total revenue from Lung Diagnostic testing, Biopharmaceutical Services and COVID-19 testing;
Excluding 2022 COVID-19 testing revenue, Guidance represents anticipated 58-67% growth.
Conference call and webcast information

Listeners can register for the webcast via this link. Analysts wishing to participate in the question-and-answer session should use this link. A replay of the webcast will be available via the Company’s investor website approximately two hours after the call’s conclusion. Those who plan on participating are advised to join 15 minutes prior to the start time.

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