Core Viewpoint - Biodesix, Inc. reported strong financial results for Q2 2025, with a revenue increase of 12% year-over-year, reaching $20.0 million, and reaffirmed its full-year revenue guidance of $80-85 million [1][6]. Financial Performance - Q2 2025 revenue was $20.0 million, a 12% increase compared to Q2 2024 [1][4]. - Gross profit margin for Q2 2025 was 80%, reflecting a 150-basis point improvement from the previous year [1][11]. - Development Services revenue grew by 53% year-over-year, reaching $2.1 million [5][20]. - Lung Diagnostic Testing revenue was $17.9 million, an 8% increase from the prior year, driven by an increase in total tests delivered [5][20]. - Adjusted EBITDA loss for Q2 2025 was $7.2 million, a 29% increase in loss compared to the same period last year [11][22]. Business Highlights - The sales team expanded to an average of 74 representatives, a 21% increase from the previous year [5]. - Primary care ordering of lung diagnostic tests increased over 100% compared to pre-pilot program levels in 2024 [5]. - The company achieved an all-time high in development services business dollars under contract, totaling $12.5 million, up 54% year-over-year [5]. - Digital ordering initiatives saw a 63% increase over the prior year [5]. - The company reached patient enrollment requirements for its ALTITUDE trial in July 2025 [5]. Future Outlook - The company is positioned to achieve Adjusted EBITDA positivity in Q4 2025, supported by sales team expansion and operational effectiveness [2]. - Biodesix maintains confidence in achieving its full-year revenue guidance of $80-85 million, indicating a focus on sustainable long-term growth [2][6].

[Q2 2025 Earnings Release Highlights](index=1&type=section&id=Q2%202025%20Earnings%20Release%20Highlights) [Executive Summary](index=1&type=section&id=Executive%20Summary) Biodesix reported strong Q2 2025 results with total revenue up 12% to $20 million, an 80% gross margin, and reaffirmed full-year guidance, expecting Q4 adjusted EBITDA profitability [Q2 2025 Financial Performance Overview](index=1&type=section&id=Q2%202025%20Financial%20Performance%20Overview) Q2 2025 Key Financial Metrics | Metric | Q2 2025 | Q2 2024 | Change (YoY) | | :-------------------- | :-------- | :-------- | :----------- | | Total Revenue | $20.0M | $17.9M | +12% | | Gross Profit Margin | 80% | 78.5% | +150 bps | [Operational and Strategic Achievements](index=1&type=section&id=Operational%20and%20Strategic%20Achievements) - The company expanded its commercial focus to primary care physicians managing **50% of lung nodule patients**, observing a significant increase in test orders from this network[2](index=2&type=chunk) - Development services revenue increased by **53% year-over-year**, with contract value growing by **54%**[2](index=2&type=chunk) - The company anticipates achieving adjusted EBITDA profitability in Q4 through sales team expansion, enhanced sales representative productivity, robust service business growth, and operational efficiencies[2](index=2&type=chunk) [Full-Year 2025 Financial Outlook](index=1&type=section&id=Full-Year%202025%20Financial%20Outlook) - The company reaffirmed its full-year 2025 total revenue guidance of **$80 million to $85 million**[1](index=1&type=chunk) [Company Information](index=2&type=section&id=Company%20Information) [About Biodesix](index=2&type=section&id=About%20Biodesix) Biodesix is a leading diagnostic solutions company improving patient care and outcomes for lung diseases through its Nodify Lung® and IQLung® tests, also offering development services for diagnostic test and therapy advancement - Biodesix is a leading diagnostic solutions company focused on improving patient clinical care and outcomes[8](index=8&type=chunk) - Its diagnostic tests, including Nodify Lung® Nodule Risk Assessment and IQLung® Cancer Treatment Guidance, support personalized care and treatment decisions for lung disease patients[8](index=8&type=chunk) - Development services provide scientific, technical, and operational capabilities to biopharmaceutical, life science, and research organizations for advancing diagnostic tests, tools, and therapies[8](index=8&type=chunk) [Trademarks](index=2&type=section&id=Trademarks) Biodesix, Biodesix Logo, Nodify Lung, and IQLung are trademarks or registered trademarks of Biodesix - Biodesix, Biodesix Logo, Nodify Lung, and IQLung are trademarks or registered trademarks of Biodesix[9](index=9&type=chunk) [Q2 2025 Business Highlights](index=1&type=section&id=Second%20Quarter%20Ended%20June%2030%2C%202025%20Business%20Highlights) Biodesix achieved significant Q2 2025 business growth and strategic progress, including sales team expansion, increased primary care physician orders, record development services contracts, and clinical data milestones - The sales team expanded to an average of **74 sales representatives**, a **21% year-over-year increase** (adding 13 representatives)[5](index=5&type=chunk) - Orders for lung diagnostic tests from primary care physicians increased by **over 100% year-over-year**, exceeding pre-2024 pilot program levels[5](index=5&type=chunk) - Development services contract value reached a record **$12.5 million**, representing a **54% year-over-year increase**[5](index=5&type=chunk) - Digital orders, including EMR integrations, increased by **63% year-over-year**[5](index=5&type=chunk) - New clinical and economic data supporting the Nodify Lung® test were presented at the ISPOR 2025 Annual Meeting and ATS 2025 International Conference[5](index=5&type=chunk) - The ALTITUDE prospective, randomized controlled trial met patient enrollment requirements in July 2025, with patient follow-up expected to continue for approximately one year[5](index=5&type=chunk) - Data from three pipeline initiatives were presented at the AACR, ASCO, and ASMS annual meetings, including combined genomic and proteomic MRD testing, VeriStrat test application in first-line immunotherapy selection, and VeriStrat test use in hormone-resistant cancers[5](index=5&type=chunk) [Q2 2025 Detailed Financial Results](index=1&type=section&id=Second%20Quarter%20Ended%20June%2030%2C%202025%20Financial%20Results) [Revenue Performance](index=2&type=section&id=Revenue%20Performance) Q2 2025 total revenue reached $20 million, a 12% year-over-year increase, driven by 8% growth in lung diagnostic testing and 53% in development services revenue Q2 2025 Revenue Breakdown | Revenue Type | Q2 2025 (Millions) | Q2 2024 (Millions) | YoY Change | | :-------------------- | :----------------- | :----------------- | :--------- | | Total Revenue | $20.0 | $17.9 | +12% | | Lung Diagnostic Testing | $17.9 | $16.5 | +8% | | Development Services | $2.1 | $1.4 | +53% | [Gross Margin and Operating Expenses](index=2&type=section&id=Gross%20Margin%20and%20Operating%20Expenses) Q2 gross margin improved to 80%, up 150 basis points, due to lung diagnostic test growth and workflow optimization, while operating expenses rose 15% from sales team expansion Q2 2025 Gross Margin and Operating Expenses | Metric | Q2 2025 (Millions) | Q2 2024 (Millions) | YoY Change | | :-------------------- | :----------------- | :----------------- | :--------- | | Gross Margin | $16.0 (80%) | N/A (78.5%) | +150 bps | | Operating Expenses | $25.7 | N/A | +15% | | Non-cash Stock Comp. | $1.0 | N/A | -15% | - Gross margin improvement was primarily driven by growth in lung diagnostic testing, reduced per-test costs from workflow optimization, and continued expansion of development services[10](index=10&type=chunk) - Increased operating expenses were primarily due to sales team expansion to support lung diagnostic sales growth, enhance market awareness, and boost product adoption, leading to higher selling and marketing costs[10](index=10&type=chunk) [Net Loss and Adjusted EBITDA](index=2&type=section&id=Net%20Loss%20and%20Adjusted%20EBITDA) Q2 net loss increased 6% to $11.5 million, and adjusted EBITDA loss widened 29% to $7.2 million Q2 2025 Net Loss and Adjusted EBITDA | Metric | Q2 2025 (Millions) | Q2 2024 (Millions) | YoY Change | | :-------------------- | :----------------- | :----------------- | :--------- | | Net Loss | $(11.5) | $(10.8) | +6% | | Adjusted EBITDA | $(7.2) | $(5.6) | +29% | [Cash and Cash Equivalents](index=2&type=section&id=Cash%20and%20Cash%20Equivalents) Cash and cash equivalents totaled $20.7 million as of June 30, 2025, an increase of $3.1 million from March 31, 2025 Cash and Cash Equivalents | Metric | As of June 30, 2025 (Millions) | As of March 31, 2025 (Millions) | Change | | :-------------------- | :----------------------------- | :------------------------------ | :----- | | Cash and Cash Equivalents | $20.7 | $17.6 (implied) | +$3.1M | [2025 Financial Outlook](index=2&type=section&id=2025%20Financial%20Outlook) The company reaffirmed its full-year 2025 financial outlook, projecting total revenue between $80 million and $85 million - The company reaffirmed its 2025 total revenue expectation of **$80 million to $85 million**[6](index=6&type=chunk) [Use of Non-GAAP Financial Measures](index=3&type=section&id=Use%20of%20Non-GAAP%20Financial%20Measure) [Adjusted EBITDA](index=3&type=section&id=Adjusted%20EBITDA) Adjusted EBITDA is a key non-GAAP metric used by Biodesix management for financial performance assessment and internal planning, derived from net loss by excluding specific non-cash and non-recurring items to provide a comparable operational overview - Adjusted EBITDA is a key metric used by company management for evaluating financial performance, internal planning, and forecasting[12](index=12&type=chunk) - This metric helps investors assess ongoing operating results and trends, facilitating comparisons with other companies[11](index=11&type=chunk) - Calculated by adjusting net loss to exclude interest, income tax expense, depreciation and amortization, share-based compensation expense, loss on extinguishment of debt, net change in fair value of warrant liability, other net income, and other non-recurring items[14](index=14&type=chunk) [Note Regarding Forward-Looking Statements](index=3&type=section&id=Note%20Regarding%20Forward-Looking%20Statements) This press release contains forward-looking statements protected by the Private Securities Litigation Reform Act of 1995, involving significant risks and uncertainties, with actual results potentially differing materially from current expectations due to various factors, including those in company filings - This press release contains forward-looking statements protected by the Private Securities Litigation Reform Act of 1995, involving significant risks and uncertainties[15](index=15&type=chunk) - Forward-looking statements are based on current management expectations, and actual results and performance may differ materially from projections due to various factors[15](index=15&type=chunk) - Readers should refer to the risk factors section in the company's latest 10-K annual report and 10-Q quarterly reports for additional factors that could cause actual results to differ[15](index=15&type=chunk) [Contacts](index=5&type=section&id=Contacts) Provides contact information for media and investor relations - Media Contact: Natalie St. Denis (natalie.stdenis@biodesix.com, (720) 925-9285)[16](index=16&type=chunk) - Investor Contact: Chris Brinzey (chris.brinzey@icrhealthcare.com, (339) 970-2843)[16](index=16&type=chunk) [Unaudited Financial Statements](index=6&type=section&id=Unaudited%20Financial%20Statements) [Condensed Balance Sheets](index=6&type=section&id=Condensed%20Balance%20Sheets) As of June 30, 2025, Biodesix reported total assets of $87.74 million, total liabilities of $86.602 million, and total stockholders' equity of $1.138 million, reflecting decreases in assets and equity and an increase in liabilities compared to December 31, 2024 Condensed Balance Sheet Key Data | Metric (in thousands) | June 30, 2025 | December 31, 2024 | | :-------------------- | :------------ | :---------------- | | Total Assets | $87,740 | $97,244 | | Total Liabilities | $86,602 | $76,368 | | Total Stockholders' Equity | $1,138 | $20,876 | | Cash and Cash Equivalents | $20,728 | $26,245 | | Long-term notes payable, net | $46,782 | $36,408 | [Condensed Statements of Operations](index=7&type=section&id=Condensed%20Statements%20of%20Operations) Q2 2025 total revenue was $20.018 million, with a net loss of $11.468 million and basic and diluted net loss per share of $0.08, indicating revenue growth but also an expanded net loss year-over-year Condensed Statements of Operations Key Data | Metric (in thousands, except per share) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------------------ | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Total Revenues | $20,018 | $17,925 | $37,976 | $32,743 | | Diagnostic Tests Revenue | $17,898 | $16,539 | $34,214 | $30,335 | | Development Services Revenue | $2,120 | $1,386 | $3,762 | $2,408 | | Net Loss | $(11,468) | $(10,808) | $(22,569) | $(24,422) | | Net Loss per Share (basic & diluted) | $(0.08) | $(0.08) | $(0.15) | $(0.22) | [Reconciliation of Net Loss to Adjusted EBITDA](index=8&type=section&id=Reconciliation%20of%20Net%20Loss%20to%20Adjusted%20EBITDA) Q2 2025 adjusted EBITDA loss widened to $7.213 million from $5.607 million in Q2 2024, with the reconciliation detailing adjustments from net loss Reconciliation of Net Loss to Adjusted EBITDA | Metric (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Net Loss | $(11,468) | $(10,808) | $(22,569) | $(24,422) | | Interest expense | $1,898 | $1,936 | $3,583 | $4,465 | | Depreciation and amortization | $1,436 | $1,412 | $2,876 | $2,832 | | Share-based compensation expense | $1,039 | $1,218 | $2,011 | $3,858 | | Adjusted EBITDA | $(7,213) | $(5,607) | $(13,409) | $(12,568) |

Company Overview - Biodesix, Inc. 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] Upcoming Event - Scott Hutton, CEO, and Robin Cowie, CFO, will present in a fireside chat and conduct in-person 1x1 investor meetings at the Canaccord Genuity 45 Annual Growth Conference on August 12, 2025 [1] - The fireside chat is scheduled for 4:30 PM ET and will be held in Boston, MA [2] - The presentation will be available for live webcast and replay on the company's website [2]

Core Viewpoint - Biodesix, Inc. will release its financial results for Q2 2025 on August 7, 2025, and will host a conference call to discuss these results and provide a business update [1]. Company Overview - Biodesix is a leading diagnostic solutions company focused on improving clinical care and outcomes for patients, particularly in lung disease [3]. - The company markets diagnostic tests such as Nodify Lung® Nodule Risk Assessment and IQLung® Cancer Treatment Guidance, which support clinical decisions for personalized care [3]. - Biodesix Development Services provide scientific, technological, and operational capabilities to biopharmaceutical and life sciences institutions, aiding in the development of diagnostic tests and therapeutics [3].

Company Overview - Biodesix is a leading diagnostics company focused on improving clinical care and patient outcomes[1, 12] - The company's mission is to transform patient care through personalized diagnostics that are timely, accessible, and address immediate clinical needs[13] - Biodesix envisions a world where patient diseases are conquered with the guidance of personalized diagnostics[14] Business Lines and Key Capabilities - Biodesix generates revenue through two business lines: Lung Diagnostic Tests and Development Services[15] - The company expects to have approximately 95 sales representatives focused on lung diagnostics in the field by 4Q25[19] - Biodesix boasts industry-leading gross margins of 794%[19] - Development Services had $109 million in contracts not yet recognized as of the end of Q1 2025[73] Lung Diagnostic Tests - Lung cancer accounts for approximately 1 in 5 cancer deaths annually in the USA[29] - Approximately 80% of patients assessed for lung cancer risk fall into the low to moderate risk category (5-65%)[37, 43] - The Nodify Lung test identifies likely malignant nodules with 78% PPV, 98% specificity, and 28% sensitivity, and identifies likely benign nodules with 98% NPV, 97% sensitivity, and 44% specificity[46] Financial Performance - Total revenue for Q1 2025 was $180 million, representing a 21% year-over-year growth[76, 78] - Lung Diagnostics revenue in Q1 2025 was $163 million, an 18% increase year-over-year[76, 81] - Development Services revenue in Q1 2025 was $17 million, a 61% increase year-over-year[76, 81]

Core Insights - Biodesix, Inc. partners with the Association of Pulmonary Advanced Practice Providers (APAPP) to enhance educational programs for lung cancer risk assessment and patient care [1][2][4] Group 1: Partnership and Educational Initiatives - The collaboration aims to provide new educational resources for lung health providers, focusing on innovative lung nodule risk assessment testing and cancer treatment decision support testing [2][3] - Programs will be introduced to educate providers in diverse care settings, including rural and metropolitan areas, to manage large and diverse patient populations [3][4] Group 2: Lung Cancer Statistics and Impact - Lung cancer is highlighted as the deadliest cancer, with nearly as many annual deaths in the U.S. as breast, prostate, and colon cancers combined [2] - Current statistics indicate that 1 in 18 Americans will receive a lung cancer diagnosis in their lifetime, emphasizing the need for earlier detection and personalized treatment options [4] Group 3: Company Profiles - Biodesix is a leading diagnostic solutions company focused on improving clinical care and outcomes for patients with lung disease through its diagnostic tests [6] - APAPP is the first association dedicated to Advanced Practice Providers in pulmonary medicine, uniting Nurse Practitioners and Physician Assistants to enhance excellence in pulmonology [5]

Biodesix (BDSX) FY Conference Summary Company Overview - Biodesix is a leading diagnostics company focused on lung health, aiming to transform patient care through personalized diagnostics that are timely and accessible [4][3] - The company generates revenue from two segments: lung diagnostic tests and biopharmaceutical services [4][5] Financial Performance - Biodesix reported $18 million in revenue for Q1, representing a 21% year-over-year growth [51] - Revenue from lung diagnostic tests was $16.3 million, growing 18%, while development services saw a significant growth of 61% [51] - The company maintains industry-leading gross margins at just under 80% and expects to reach adjusted EBITDA breakeven by the end of the year [7][52] Product Portfolio - Biodesix has five Medicare-covered lung diagnostic tests, with three having advanced diagnostic laboratory status [6][7] - The company is expanding into digital diagnostics to complement its proteomic and genomic solutions [6] - The lung diagnostic portfolio includes tests for lung nodule risk assessment and treatment guidance [11][37] Market Opportunity - Lung cancer remains the deadliest cancer in the U.S., with one in five cancer-related deaths attributed to it [10][11] - The company aims to address the significant gap in early diagnosis and treatment selection for lung cancer patients [11][12] Clinical Studies and Data Development - Biodesix is conducting two key studies: ALTITUDE (a randomized prospective study) and CLARIFY (a retrospective chart review study) to demonstrate the efficacy and utility of its tests [24][25] - The company has published over 300 clinical publications and presentations, focusing on health economics and outcomes data [6][23] Sales Strategy - Biodesix plans to expand its sales force to 95 representatives by year-end, focusing on pulmonology [6] - The company is also targeting primary care physicians to improve patient referrals to pulmonologists, addressing the issue that many patients do not see specialists [32][35] Future Developments - The company is working on four tests in development, including a risk of recurrence test that combines proteomic and genomic data [42][43] - Biodesix is exploring expanded indications for its Veristrat test in other disease states, including prostate cancer [45][46] - The company is also venturing into digital diagnostics to enhance patient identification and improve test outcomes [47][48] Conclusion - Biodesix is positioned for transformative growth in 2025, with a strong focus on data development and expanding its product pipeline [53][54] - The company emphasizes the importance of its pulmonology-focused sales force and the potential impact of its diagnostic solutions on patient outcomes [54]

Core Insights - New data from the INSIGHT study indicates that the VeriStrat Host Immune Classifier can predict overall survival in non-small cell lung cancer patients treated with immunotherapy [1][2] - The presentation of this data will occur at the 2025 ASCO Annual Meeting, highlighting the significance of the findings [1] Group 1: Study Findings - The VeriStrat test categorizes patients' immune responses as either Hot (VeriStrat Good) or Cold (VeriStrat Poor) [2] - Statistically significant improvement in overall survival was observed in patients with a VeriStrat Poor result when treated with immunotherapy combined with chemotherapy, compared to those receiving immunotherapy alone [2] - The two-year survival rate for patients receiving the combination treatment was over three times higher than for those on immunotherapy alone [2] Group 2: Clinical Implications - The VeriStrat test may assist oncologists in evaluating treatment benefits and risks, potentially guiding decisions on treatment escalation or de-escalation [3] - Preliminary results from another ongoing study suggest that the VeriStrat test may also be applicable for other solid tumors, with data expected to be published later in 2025 [3] Group 3: Company Overview - Biodesix is a leading diagnostic solutions company focused on improving clinical care and outcomes for patients, particularly in lung disease [4] - The company offers diagnostic tests such as Nodify Lung® Nodule Risk Assessment and IQLung™ Cancer Treatment Guidance to support personalized care [4]

Group 1 - Biodesix, Inc. will participate in two upcoming investor conferences: the 22nd Annual Craig-Hallum Institutional Investor Conference on May 28, 2025, and the 45th Annual William Blair Growth Stock Conference on June 4, 2025 [1] - The presentation at the William Blair Growth Stock Conference will be webcast live and available for replay on the company's website [1] Group 2 - Biodesix is a leading diagnostic solutions company focused on improving clinical care and outcomes for patients, particularly in lung disease [2] - The company's diagnostic tests, Nodify Lung® and IQLung™, support clinical decisions to expedite personalized care [2] - Biodesix Development Services provide scientific, technological, and operational capabilities to biopharmaceutical and life sciences institutions for developing diagnostic tests and therapeutics [2]

Core Insights - Biodesix, Inc. announced new data presentations at ISPOR 2025 and ATS 2025, focusing on lung cancer diagnosis and management [1][2][4] Group 1: Study Findings - A study involving over 350,000 patients revealed that approximately two-thirds do not receive clinical work-up after lung nodule discovery, indicating a significant gap in patient management [3] - The study also found that 60% of biopsies were performed on benign nodules, while 35% of malignant nodules did not receive timely follow-up CT scans, highlighting the need for improved triage methods [3] Group 2: Clinical Applications - The Nodify Lung testing was shown to play a crucial role in lung cancer screening programs, providing actionable results that can guide management decisions [5] - Biodesix's diagnostic tests, including Nodify Lung Nodule Risk Assessment and IQLung™ Cancer Treatment Guidance, are designed to enhance clinical decision-making and improve patient outcomes [6]