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Biodesix(BDSX) - 2025 Q1 - Quarterly Report
BDSXBiodesix(BDSX)2025-05-13 20:10

Financial Performance - Total revenue for Q1 2025 was 18.0million,representinga2118.0 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 1.7millionforQ12025,anincreaseof611.7 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 17.958million,a2117.958 million, a 21% increase from 14.818 million in Q1 2024[181] - Diagnostic Tests revenue increased by 2.5millionor182.5 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 11.1million,animprovementof1811.1 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 0.8millionor410.8 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 23.4millionforQ12025,a323.4 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 17.6millionasofMarch31,2025,withaproformacashbalanceof17.6 million as of March 31, 2025, with a pro forma cash balance of 27.6 million after receiving 10millionfromaloanfacility[170]TheCompanyrecordedanetcashflowusedinoperatingactivitiesof10 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 6.7millioncomparedto6.7 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 8.6millionforthethreemonthsendedMarch31,2025,comparedtoadecreaseof8.6 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 51.3millionfromanunderwrittenofferingofcommonstockandaconcurrentprivateplacementonApril9,2024[196]TheCompanyhasatotalof51.3 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 5.4millionduewithinoneyear[205]TheCompanyamendedtheCreditAgreementtoextendtheTrancheCLoanavailabilitytoDecember31,2025,withatotalamountof5.4 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 0.4millionlossduetochangesinthefairvalueofwarrantliabilityduringthethreemonthsendedMarch31,2025[190]TheCompanyhadnetcashprovidedbyfinancingactivitiesof0.4 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 0.7millioncomparedtothesameperiodin2024[204]ComplianceandRegulatoryTheCompanyissubjecttoacomplianceperioduntilSeptember22,2025,toregaincompliancewithNasdaqsMinimumBidPriceRequirementof0.7 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 50.0millionunderthe2024ATMProgramasofMarch31,2025[198]Thecompanywillremainanemerginggrowthcompanyuntilitexceeds50.0 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 40.0millionoutstandingonthePerceptiveTermLoanFacility,withanannualinterestrateofatleast3.040.0 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]