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Financial Data and Key Metrics Changes - Total revenue for Q3 2025 was $21.8 million, representing a 20% increase year-over-year [17] - Gross margin improved by 400 basis points to 81% compared to 77% in Q3 2024 [19] - Adjusted EBITDA loss improved by 18% year-over-year to a loss of $4.6 million [21] Business Line Data and Key Metrics Changes - Lung diagnostic testing revenue was $19.8 million from approximately 15,700 tests, a 16% increase in revenue and 13% growth in test volumes compared to Q3 2024 [18] - Development services revenue grew 97% year-over-year to $1.9 million, with $12.9 million under contract, marking a 16% increase [14][19] Market Data and Key Metrics Changes - The company expanded its access to the lung nodule market, increasing the percentage of Nodify tests ordered from primary care from 4% to 11% in September 2025 [7] - Digital test ordering capabilities increased by 43% over the previous year [10] Company Strategy and Development Direction - The company is focused on three main goals: growing top-line revenue, improving operational effectiveness, and advancing its product pipeline [4] - A three-tiered commercial strategy has been implemented to enhance lung nodule management and increase growth potential [5] - The company is leveraging partnerships with Bio-Rad Laboratories and Thermo Fisher Scientific to expand its product development pipeline [15][16] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving adjusted EBITDA positivity in Q4 2025, supported by strong revenue growth and improved gross margins [22][37] - The company is increasing its revenue guidance for 2025 to a range of $84-$86 million based on current momentum [17] Other Important Information - The company presented interim data from the Clarify study at the CHEST annual meeting, reinforcing the clinical utility of Nodify testing [11][12] - The company is actively working to resolve administrative barriers with Medicare Advantage plans, which contributed to revenue growth [18] Q&A Session Summary Question: Can you discuss the signals that your primary care expansion is working? - Management highlighted that initial proof points come from pulmonologists introducing the company to their referral networks, leading to increased adoption and earlier diagnosis [25][26] Question: What can investors expect regarding product portfolio expansion into 2026? - Management indicated that an R&D event will provide updates on ongoing efforts and pipeline developments, emphasizing the importance of partnerships [28][29] Question: What is the ramp-up plan for the new sales reps and expected productivity? - Management noted a consistent ramp-up in sales rep productivity, aiming for $1 million per sales rep at full productivity [31][32] Question: How confident is the company in achieving adjusted EBITDA positivity in Q4? - Management expressed strong confidence in reaching adjusted EBITDA positivity based on Q3 performance and momentum into Q4 [36][37]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-39659 BIODESIX, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 20-3986492 (State or other jurisdictio ...

Exhibit 99.1 Biodesix Announces Third Quarter 2025 Results and Highlights Q3 2025 Revenue of $21.8 million, an increase of 20% over Q3 2024; Q3 2025 gross profit margin of 81%, a 400-basis point improvement from Q3 2024; Raised FY2025 Total Revenue Guidance to $84-86 million; Conference Call and Webcast Today at 4:30 p.m. ET LOUISVILLE, CO, November 3, 2025 – Biodesix, Inc. (Nasdaq: BDSX), a leading diagnostic solutions company, today announced its financial and operating results for the third quarter ended ...

Q3 2025 Revenue of $21.8 million, an increase of 20% over Q3 2024; Q3 2025 gross profit margin of 81%, a 400-basis point improvement from Q3 2024; Raised FY2025 Total Revenue Guidance to $84-86 million; Conference Call and Webcast Today at 4:30 p.m. ET LOUISVILLE, Colo., Nov. 03, 2025 (GLOBE NEWSWIRE) -- Biodesix, Inc. (Nasdaq: BDSX), a leading diagnostic solutions company, today announced its financial and operating results for the third quarter ended September 30, 2025. “We delivered a strong third quarte ...

Core Insights - Biodesix, Inc. will present its Corporate and Scientific updates at the 2025 AMP Annual Meeting in Boston from November 12-15, highlighting its diagnostic solutions and strategic partnerships [1][2]. Group 1: Corporate Workshop - A workshop led by Dr. Gary Pestano will focus on Biodesix's R&D Roadmap, showcasing both near- and long-term diagnostic services [2]. - Key partners such as Memorial Sloan Kettering Cancer Center, Bio-Rad Laboratories, and Thermo Fisher Scientific will provide updates during the workshop [2]. Group 2: Molecular Testing Approaches - The workshop will emphasize new approaches to comprehensive molecular testing, aiming for accurate results with rapid turnaround, high throughput, and low sample requirements [3][4]. - Advances in molecular diagnostic technologies, including NGS, ddPCR, and Mass Spectrometry, will be discussed, along with their clinical utility and research concepts for monitoring therapeutic responses [4]. Group 3: Company Overview - Biodesix is dedicated to enhancing clinical care and outcomes for patients, particularly in lung disease, through its diagnostic tests like Nodify Lung® and IQLung® [7]. - The company provides Development Services to biopharmaceutical and life sciences institutions, supporting the development of diagnostic tests and therapeutics [7]. Group 4: Presentation and Engagement - A poster presentation on the impact of blood collection tubes on a novel device for enriching circulating tumor cells will be presented by Leisa Jackson on November 15 [6]. - Biodesix executives and experts will be available at booth 647 to discuss the company's offerings during the AMP Annual Meeting [5].

Core Insights - Biodesix has signed an expanded partnership agreement with Bio-Rad to develop and clinically validate the ddPLEX ESR1 Mutation Detection Assay for advanced breast cancer testing [1][2][4] - The assay will enable highly sensitive detection and quantification of multiple ESR1 mutations from ctDNA samples, which is critical for HR+/HER2- advanced breast cancer treatment [2][3] - Biodesix plans to offer the validated assay as a test service at its accredited CLIA-CAP laboratory and will seek reimbursement through the Centers for Medicare & Medicaid Services (CMS) [3] Company Developments - The first assay to be validated under the agreement is Bio-Rad's ddPLEX ESR1 Mutation Detection Assay, which is essential for the new generation of therapies known as oral selective estrogen receptor degraders (SERDs) [2] - Biodesix aims to improve clinical care and outcomes for patients through its diagnostic solutions, including the Nodify Lung® Nodule Risk Assessment and IQLung® Cancer Treatment Guidance [5] Market Impact - The emergence of ESR1 mutations as biomarkers for breast cancer has significantly increased global demand for rapid and sensitive assays in the oncology market [4] - The collaboration between Biodesix and Bio-Rad is expected to enhance access to sensitive biomarker detection for advanced breast cancer, addressing clinical needs with speed and precision [4] Upcoming Events - Both companies will present more details on their R&D visions, partnerships, and commercial roadmaps at the upcoming AMP conference scheduled for November 11-15 in Boston, MA [4]

Core Points - Biodesix, Inc. will release its financial results for Q3 2025 on November 3, 2025, after market close [1] - A conference call and webcast will be held at 4:30 p.m. Eastern Time on the same day to discuss the results and provide a business update [1] - Registration links for the webcast and Q&A session are available for analysts and listeners [2] Company Overview - Biodesix is a leading diagnostic solutions company focused on improving clinical care and outcomes for patients [3] - The company offers diagnostic tests such as Nodify Lung Nodule Risk Assessment and IQLung Cancer Treatment Guidance, which aid in clinical decision-making for lung disease [3] - Biodesix Development Services support biopharmaceutical and life sciences institutions in developing diagnostic tests and therapeutics [3]

Core Insights - Biodesix, Inc. is set to present preliminary data from the CLARIFY study at the 2025 CHEST Annual Meeting, focusing on lung nodule management and the performance of Nodify tests [1][2]. Group 1: CLARIFY Study Overview - The CLARIFY study aims to validate the performance of Nodify CDT and Nodify XL2 tests through a retrospective chart review of up to 4,000 patients, with a focus on diverse patient subgroups [2]. - The study began patient enrollment shortly after the 2024 CHEST Annual Meeting and has already enrolled 1,000 patients for interim analysis [2]. Group 2: Presentations at CHEST Annual Meeting - A national analysis on lung nodule management will be presented, emphasizing the need for structured approaches to optimize healthcare resource utilization and improve patient outcomes [3]. - Multiple independent presentations will highlight the clinical value of Nodify Lung tests in various real-world patient populations [3]. Group 3: Additional Presentations - Specific presentations include comparisons of the Nodify XL2 test with PET/CT for evaluating malignancy in pulmonary nodules and the impact of Nodify Lung Test strategy in risk stratification [4]. - Other topics include the association of lung cancer screening with proteomic testing in minority communities and retrospective analyses of Biodesix biomarkers [4]. Group 4: Company Vision and Market Context - Biodesix emphasizes the transformative potential of biomarkers in lung diagnostics, coinciding with Lung Cancer Awareness Month starting November 1 [5]. - The company is dedicated to improving clinical care and outcomes for patients with lung disease through its diagnostic tests and development services [5].

Core Insights - Biodesix, Inc. is collaborating with three prominent lung health organizations to enhance education and advocacy for healthcare professionals and patients in Colorado [1][5] Group 1: Events Overview - The first event, "Know Your Nodules," will take place on October 9 at Biodesix's headquarters, focusing on lung disease and cancer screening [2] - The second event is the "Go2 for Lung Cancer Centers of Excellence Summit," occurring from October 9 to 11 in Denver, which aims to standardize best practices in lung nodule management [3] - The third event, "Run the Rocks," organized by the American Lung Association, will be held on October 12 at Red Rocks Amphitheater to raise funds for lung health education and research [4] Group 2: Company Mission and Goals - Biodesix's CEO, Scott Hutton, emphasized the importance of these events in supporting the company's mission to conquer lung diseases through personalized diagnostics [5] - The October events are strategically scheduled ahead of Lung Cancer Awareness Month in November, highlighting Biodesix's commitment to advocacy and awareness [5] Group 3: Company Background - Biodesix is recognized as a leading diagnostic solutions company, focusing on improving clinical care and outcomes for patients with lung diseases [6] - The company's diagnostic tests, including Nodify Lung Nodule Risk Assessment and IQLung Cancer Treatment Guidance, are designed to support clinical decisions and expedite personalized care [6]