Biodesix(US:BDSX)2025-05-13 20:10Financial Performance - Total revenue for Q1 2025 was $18.0 million, representing a 21% increase compared to the same period in 2024[165] - Diagnostic Testing revenue reached $16.3 million for Q1 2025, an 18% increase year-over-year, primarily driven by an increase in total tests delivered[165] - Development Services revenue was $1.7 million for Q1 2025, an increase of 61% compared to the same period in 2024[170] - Gross margin for Q1 2025 was $14.3 million, or 79.4%, compared to 78.6% in the prior year, driven by growth in diagnostic testing and optimization of testing workflows[170] - Total revenues for Q1 2025 were $17.958 million, a 21% increase from $14.818 million in Q1 2024[181] - Diagnostic Tests revenue increased by $2.5 million or 18% in Q1 2025, primarily due to a $2.7 million increase in the Nodify Lung Nodule Risk Assessment testing strategy[183] - Net loss for Q1 2025 was $11.1 million, an improvement of 18% compared to a net loss of $13.6 million in Q1 2024[181] Research and Development - The ongoing INSIGHT study has enrolled 5,000 patients with non-small cell lung cancer, with expected follow-up completion by 2026[160] - The company aims to develop a new molecular minimal residual disease (MRD) test in collaboration with Memorial Sloan Kettering Cancer Center[163] - The ALTITUDE study seeks to further demonstrate the utility of the Nodify CDT and XL2 tests, enhancing clinical validation[161] - Research and development expenses rose by $0.8 million or 41% in Q1 2025, attributed to increased internal compensation and external clinical trial costs[186] - Total external research and development costs increased by $364 thousand or 42% in Q1 2025 compared to Q1 2024[187] Operational Efficiency - The Nodify CDT and XL2 tests have an average turnaround time of one and five business days, respectively, providing timely results for lung cancer diagnosis[149] - The GeneStrat ddPCR test can be used multiple times per patient to monitor changes in mutation status, enhancing treatment decision-making[152] - Operating expenses (excluding direct costs) were $23.4 million for Q1 2025, a 3% increase from the prior year, with R&D costs increasing by $900 thousand[170] Financial Position and Cash Flow - Cash and cash equivalents were $17.6 million as of March 31, 2025, with a pro forma cash balance of $27.6 million after receiving $10 million from a loan facility[170] - The Company recorded a net cash flow used in operating activities of $8.6 million for the three months ended March 31, 2025, a decrease of approximately $6.7 million compared to $15.3 million for the same period in 2024[202] - The net decrease in cash and cash equivalents and restricted cash was $8.6 million for the three months ended March 31, 2025, compared to a decrease of $14.8 million for the same period in 2024[202] - The Company raised net proceeds of approximately $51.3 million from an underwritten offering of common stock and a concurrent private placement on April 9, 2024[196] - The Company has a total of $54.4 million in borrowings and interest obligations, with $5.4 million due within one year[205] - The Company amended the Credit Agreement to extend the Tranche C Loan availability to December 31, 2025, with a total amount of $10.0 million[199] - The Company recorded a $0.4 million loss due to changes in the fair value of warrant liability during the three months ended March 31, 2025[190] - The Company had net cash provided by financing activities of $0.1 million for the three months ended March 31, 2025, a decrease of $0.7 million compared to the same period in 2024[204] Compliance and Regulatory - The Company is subject to a compliance period until September 22, 2025, to regain compliance with Nasdaq's Minimum Bid Price Requirement of $1.00 per share[200] - The Company has remaining available capacity for share issuances of up to $50.0 million under the 2024 ATM Program as of March 31, 2025[198] - The company will remain an emerging growth company until it exceeds $1.24 billion in annual revenue or meets other specified criteria[214] - The company is classified as a "smaller reporting company" and will maintain this status until certain market value and revenue thresholds are met[215] Interest and Market Risk - As of March 31, 2025, the company had $40.0 million outstanding on the Perceptive Term Loan Facility, with an annual interest rate of at least 3.0% plus a margin of 9.0%[217] - A hypothetical 100 basis point increase in interest rates would result in an estimated $0.4 million impact per year on the company's financial position[219] - The company has not entered into derivative agreements to manage floating interest rate exposure[217] - The company maintains cash and cash equivalents primarily at one U.S. financial institution, monitoring credit quality continuously[218] - The company is exposed to market risk due to potential adverse changes in financial market prices and rates[216] - The company has opted for reduced disclosure requirements available to emerging growth companies, complicating financial comparisons with other public companies[213]