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]

Core Insights - Biodesix, Inc. has been recognized as a Colorado Top Workplaces 2025 Winner, highlighting its commitment to a people-first organizational culture [1] - This recognition is based on employee feedback collected through a third-party survey conducted by Energage, which measures various aspects of the employee experience [2] - This marks the second consecutive year that Biodesix has received such recognition, following the Inc. Magazine 2024 Best Workplaces award [3] Company Overview - Biodesix is a leading diagnostic solutions company focused on improving clinical care and outcomes for patients, particularly those with lung disease [4] - The company offers diagnostic tests that support clinical decisions and expedite personalized care, as well as development services for biopharmaceutical and life sciences companies [4] Employee Engagement - The Top Workplaces award is based on themes such as respect, support, growth opportunities, and empowerment within the workplace [2][4] - The CEO of Biodesix emphasized the importance of employee contributions to the company's high-performing culture and commitment to excellence [3] About Energage - Energage is a company that specializes in turning employee feedback into actionable business intelligence and employer recognition through the Top Workplaces program [5] - The organization has a rich history of culture research, having surveyed over 27 million employees across more than 70,000 organizations [5]

Company Performance - Biodesix, Inc. reported a quarterly loss of $0.08 per share, which aligns with the Zacks Consensus Estimate, an improvement from a loss of $0.14 per share a year ago [1] - The company posted revenues of $17.96 million for the quarter ended March 2025, missing the Zacks Consensus Estimate by 7.19%, but showing an increase from $14.82 million year-over-year [2] - Over the last four quarters, Biodesix has surpassed consensus EPS estimates three times, while it has topped consensus revenue estimates only once [2][3] Stock Performance - Biodesix shares have declined approximately 76.5% since the beginning of the year, contrasting with the S&P 500's decline of only 0.6% [3] - The current consensus EPS estimate for the upcoming quarter is -$0.06 on revenues of $22.3 million, and for the current fiscal year, it is -$0.22 on revenues of $92.75 million [7] Industry Outlook - The Medical Services industry, to which Biodesix belongs, is currently ranked in the top 27% of over 250 Zacks industries, indicating a favorable outlook compared to the bottom 50% [8] - Empirical research suggests a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can impact Biodesix's stock performance [5][6]

Financial Data and Key Metrics Changes - Total revenue for the first quarter was $18 million, representing a 21% increase year over year [24] - Lung diagnostic testing revenue was $16.3 million, with a 18% growth in revenue and 16% growth in test volumes [24] - Gross margin improved to 79.4%, up from 78.6% in the prior year [25] - Net loss for the quarter was $11.1 million, an 18% improvement year over year [26] - Adjusted EBITDA loss was $6.2 million, an 11% improvement year over year [26] Business Line Data and Key Metrics Changes - Lung diagnostics revenue grew 18%, marking the sixteenth consecutive quarter of over 15% year-over-year growth [6] - Development services revenue was $1.7 million, a 61% increase over the previous year [24] - The pipeline for development services ended the quarter with $10.9 million under contract, a 21% increase year over year [25] Market Data and Key Metrics Changes - The company is focusing on expanding its presence in the primary care market, which is critical for lung nodule management [8][11] - Digital ordering capabilities increased by 58% over the last year, with customer retention for digital users being 40% higher [10] Company Strategy and Development Direction - The company aims to achieve positive adjusted EBITDA by the fourth quarter of 2025 while focusing on revenue growth and operational efficiencies [5][28] - A shift to a territory-based sales approach has been implemented to enhance market access and patient identification [11][13] - The company is exploring the integration of AI and radiomics into its diagnostic offerings to improve clinical workflows [14][15] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving revenue growth despite current hiring delays and operational challenges [28][47] - The company anticipates an acceleration of growth in the second half of 2025 as the sales team expands [27] - Management highlighted the importance of maintaining operational efficiencies and cost control to reach profitability [26][82] Other Important Information - The company has been recognized as a top workplace for the second consecutive year, reflecting its strong team culture [30] - A research and development day is planned for the fall to provide further insights into the company's pipeline and progress [22] Q&A Session Summary Question: Can you elaborate on the sales force changes and hiring challenges? - Management noted that the shift from pulmonology to primary care required a different hiring profile, which took longer than anticipated [34][35] Question: What is the outlook for Q2 and the rest of the year? - The company expects to have 70 to 75 sales reps in Q2, with plans to increase to 95 by Q4 [41] Question: How are primary care physicians responding to the technology? - Early feedback indicates that primary care physicians are recognizing the value of the diagnostic tests, with a focus on identifying high-risk patients [44][66] Question: What is the impact of the $10 million loan on capital needs? - The additional capital provides more flexibility and confidence in achieving breakeven, supporting both commercial expansion and pipeline activities [47][48] Question: How does the sales force configuration affect territory management? - The company is strategically assigning sales reps based on test volumes and geographic considerations to maximize market access [96]