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 - 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]

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]

Biodesix, Inc. (NASDAQ:BDSX) Q4 2024 Earnings Conference Call March 3, 2025 4:30 PM ET Company Participants Chris Brinzey - Investor Relations Scott Hutton - Chief Executive Officer Robin Harper Cowie - Chief Financial Officer Conference Call Participants Andrew Brackmann - William Blair Kyle Mikson - Canaccord Dan Brennan - TD Cowen Thomas Flaten - Lake Street Capital Markets William Bonello - Craig-Hallum Sung Ji Nam - Scotiabank Operator Good day, and thank you for standing by. Welcome to the Biodesix, I ...