Scott Hutton
Analyst · Lake Street Capital Markets
Thank you, Chris, and thank you all for joining us today. Biodesix continued to make meaningful progress in the third quarter with total revenue growing 10%, diagnostic testing revenue increasing 16%, test volumes growing 24% and gross margin remaining strong at 81%. While we are proud of that growth, our results did not meet our expectations. The shortfall was driven by 3 factors: fewer contributing sales representatives than planned, greater-than-anticipated seasonality in primary care and customer-delayed start of several development services projects. The important point is that these were execution and timing challenges, not changes in demand, clinical utility, competitive position or the size of the opportunity in front of us. We understand what drove the quarter. We have already taken action, and we entered the fourth quarter with improved commercial capacity and a clear focus on execution. Today, I will discuss both the drivers of our quarterly performance and the strategic and clinical progress that continue to strengthen our confidence in the future. During the quarter, we strengthened our long-term leadership position in lung diagnostics through 3 developments. First, the American College of Chest Physicians, or CHEST, introduced a framework for biomarker-guided lung nodule management. Second, we expanded into multimodal digital diagnostics. And third, we accelerated development of complementary MRD programs. These achievements reinforce our belief that Biodesix is uniquely positioned at the intersection of diagnostics, imaging, molecular diagnostics and artificial intelligence. While we have work to do, our opportunity has never been clearer and our conviction has never been stronger. Starting with diagnostic testing. We delivered approximately 19,400 tests, our second highest quarterly volume and a 24% increase over the third quarter of 2025. Primary care represented approximately 15% of Nodify volumes, which was consistent with last quarter. And we continue to see strong retention among our base of ordering physicians. However, test volume per physician was affected by greater-than-anticipated seasonality, particularly in primary care. This is our first full year executing a focused primary care strategy. As we continue to expand the market, we're gaining a deeper understanding of how seasonal patient flow, physician schedules, practice patterns and the availability of lung nodule patients influence ordering behavior throughout the year. These insights are important because they strengthen our ability to forecast demand, allocate resources and execute more effectively. Importantly, what we saw was not a reduction in physician adoption, retention or interest in our test. It was a matter of timing and utilization patterns within a growing primary care business. We've incorporated these learnings into our forecasting and commercial planning, and they're already shaping how we approach execution going forward. During the quarter, we averaged 101 sales representatives in the field, below both our expectations for third quarter and our second quarter average. As a result, a greater portion of our commercial effort was focused on maintaining existing accounts, reducing our capacity to acquire new ordering physicians. Two factors contributed to the lower headcount. First, turnover was higher than anticipated, particularly within our newer primary care territories. Second, our hiring pace did not keep up with both attrition and our planned growth during the quarter. We moved quickly to address both issues, focusing on stabilizing territories, supporting existing customers and accelerating hiring and onboarding. Our expansion into primary care has also given us valuable insights into the unique workflow, support and development needs of these representatives, and we are applying those lessons to how we recruit, train, manage and support our commercial team. As we've said previously, the majority of our growth investments are concentrated in primary care. The experience of this year has made us a stronger commercial organization, and we believe the actions we have taken position us to improve execution, expand physician adoption and capture the opportunity ahead. We now have approximately 110 sales representatives in the field focused on new physician acquisition and growth within existing accounts. We plan to exit the year with approximately 115 representatives, providing increased commercial capacity as we begin 2027. Early fourth quarter trends are encouraging. We're seeing accelerating new physician acquisition, continued growth across our established customer base and broader physician engagement. In fact, October was our strongest month of new physician acquisition this year, reinforcing our belief that the actions we have taken are already translating into improved commercial execution. In parallel, we are advancing digital ordering, EMR integrations, clinical data publications and health system integrations to make routine ordering easier for clinicians and less dependent on high-touch sales activity. At the same time, we strengthened our leadership position in lung diagnostics through several important milestones. Most notably, CHEST recently announced a new lung nodule management framework that will support broader health system integration of our testing. The framework provides practical guidance for building comprehensive lung nodule programs and identifies validated biomarker testing as a core component of standardized risk stratification. Just as importantly, the framework represents meaningful recognition of the role validated biomarkers can play in improving lung nodule management and supports the growing body of evidence behind tests such as Nodify XL2 and Nodify CDT. At CHEST in October, investigators presented real-world evidence from independent physician groups, along with analyses from the CLARIFY study involving more than 2,000 patients. This data evaluated clinical utility, patient follow-up and the integration of biomarker testing with PET imaging, further strengthening the evidence supporting the use of Nodify testing in lung nodule management programs. More importantly, we are beginning to see the evidence translate into health system integrations. Increasingly, leading institutions are implementing enterprise-wide lung nodule management pathways rather than relying on physician-by-physician adoption. For example, a major integrated health system on the West Coast has begun implementing a protocol lung nodule management program, which incorporates Nodify Lung testing within both pulmonologists and primary care physicians. At the same time, one of the nation's premier academic medical centers in the same region has begun implementing a similar care pathway that incorporates Nodify testing as part of a standardized approach to lung nodule evaluation. These implementations are important because they demonstrate how our tests can become embedded within a system-wide clinical workflow rather than depending solely on individual physician adoption. We believe this approach has the potential to improve consistency of care, expand patient access to evidence-based risk assessment and create a more scalable path for growth. Importantly, enterprise-level integrations require a deliberate rollout. Establishing care pathways, aligning clinical stakeholders, training physicians and integrating software workflows is a multistep process. While implementation takes time, these early wins strongly validate our strategy and represent the type of integrations that can create durable, scalable volume growth over time. As we work to expand adoption of our current test, we're also building the next generation of lung diagnostics. Our recently announced digital diagnostics initiative begins with a radiomics-based lung nodule risk assessment test being developed in collaboration with Vanderbilt University and Vanderbilt Health. Designed to complement the Nodify lung portfolio, we anticipate commercializing the test in 2028. This initiative extends Biodesix beyond blood-based diagnostics and advances our vision of integrating imaging, molecular diagnostics and artificial intelligence into a more comprehensive approach to lung disease management. We believe the future of lung diagnostics will not be defined by a single technology, but by the intelligent integration of imaging, biomarkers, clinical data and artificial intelligence. This multimodal approach can improve clinical decision-making, strengthen patient care and create new opportunities for innovation across pulmonary medicine. Our digital diagnostics strategy positions Biodesix at the center of this transformation. We recently provided additional detail on our 2 complementary approaches to MRD testing, which we are developing with leading collaborators from industry and academia. Our tumor-informed assay developed with Bio-Rad Laboratories combines our Diagnostic Cortex bioinformatics platform with Droplet Digital PCR technology to track patient-specific variants with parts per million sensitivity. Our tumor-naive assay developed with Thermo Fisher Scientific detects methylated ctDNA using rapid NGS on the Genexus platform and extends monitoring to patients without access to usable tumor tissue. Together, these programs are designed to address a broader range of patients, clinical settings and physician needs. Importantly, these assays are being built on platforms with global reach. Through our collaborations, we have the opportunity to participate in the growth of the MRD market well beyond the limits of a traditional centralized laboratory model, expanding access for laboratories, clinicians and patients around the world. We will present data from both programs during a dedicated corporate workshop and across multiple presentations at next week's AMP meeting in Seattle. Turning to Development Services. Third quarter revenue was approximately $1 million compared to $1.9 million a year ago. As we have discussed previously, project initiation is driven by the customer and can shift between quarters. Our development service business continues to create value for our partners and for patients, and demand remains strong. We exited the quarter with $8.7 million under contract, an increase over the prior quarter and a growing interest in our offering. One example, and a recent addition to our offering, is the GeneStrat ESR1 ddPCR test, which we developed in collaboration with Bio-Rad and recently brought into our CLIA-certified New York State CLEP-approved laboratory. The test uses ultrasensitive droplet digital PCR technology to detect ESR1 mutations associated with treatment resistance in patients with metastatic breast cancer. In a blinded comparison conducted with investigators at Memorial Sloan Kettering Cancer Center, preliminary results published in the Journal of Liquid Biopsy demonstrated 100% concordance with validated reference NGS assays. The full clinical study will be presented at the San Antonio Breast Cancer Conference in December. While development services revenue can vary from quarter-to-quarter based on customer project timing, the underlying demand for our capabilities remain strong. More importantly, these collaborations reinforce our position as a trusted development partner and demonstrate how Biodesix can create value beyond our core diagnostic testing. In summary, our immediate focus is restoring commercial momentum, improving execution and increasing dollars under contract for our development services while continuing to advance the clinical evidence, strategic capabilities and partnerships that we believe will support durable long-term growth. The opportunity in front of us remains substantial, and we believe Biodesix is better positioned today than ever before. With that, I will turn the call over to Robin to review our financial performance and outlook. Robin?