Biodesix, Inc.

Good day and thank you for standing by. Welcome to the Biodesk's third quarter 2025 earnings conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you'll need to press star 1-1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1-1 again. Please be advised today's conference is being recorded. I would now like to hand the conference over to your speaker today. Chris Brinzey, please go ahead.

Thank you, Operator, and good afternoon, everyone. Today, Biodesics released results from the third quarter of 2025. Leading the call today will be Scott Hutton, Chief Executive Officer. He is joined by Robin Harper-Cowie, Chief Financial Officer. An audio recording of today's call and the press release announcement with the quarterly results can be found in the Investor Relations section of the company's website at biodesics.com. As today's call includes forward-looking statements, we encourage you to review the statements contained in today's press release and the risks and uncertainties described in our SEC filings, which identify certain factors that may cause the company's actual events, performance, and results to differ materially from those contained in the forward-looking statements made on today's webcast. In addition, we will discuss non-GAAP financial measures on this call, description, of these non-GAAP financial measures and reconciliations of GAAP to non-GAAP financial measures are included in today's press release. I would now like to turn the call over to Scott Hutton, Chief Executive Officer. Scott?

Thank you, Chris, and thank you all for joining us today. At Biodesics, our mission is to transform patient care and improve outcomes through personalized diagnostics that are timely, accessible, and address immediate clinical needs. We leverage a multimodal approach that includes genomics, proteomics, and radiomics combined with AI to discover, develop, and commercialize innovative diagnostic tests for physicians, biopharmaceutical, life sciences, and diagnostic companies to help improve patient care. In 2025, we are focused on three main goals, growing our top-line revenue, improving operational effectiveness and efficiencies, that will help drive a positive adjusted EBITDA in the fourth quarter and advancing our pipeline for future growth and expansion. In the third quarter, we made progress on all three of these goals. Our growth is accelerating with revenue up 20 percent. We improved upon our already strong gross margins by 400 basis points to 81 percent. We improved adjusted EBITDA by 18 percent and we present clinical data that continues to support the use of our on-market products and demonstrates the potential of our product pipeline. Starting with our clinical offerings in lung diagnostics, our major focus remains on lung nodule management, where nodules are either found during low-dose CT screening for lung cancer or, incidentally, when the patient has an image taken for another purpose. We have implemented a three-tiered commercial strategy that helps to improve the management of patients with lung nodules and increases the growth potential of our on-market test. This strategy started at the launch of Notify testing with the interventional pulmonologist, who are typically responsible for diagnosing lung cancer. We then expanded into their referral network in general and community pulmonology. Most recently, in this past year, we have very selectively expanded further into the referral network by calling on primary care providers. By taking this next step into the pulmonology referral network, we have expanded our access to the available nodule market that includes 50% of patients with pulmonary nodules who are managed in primary care. This approach enhances the value of notified lung testing by first helping general pulmonologists and primary care providers triage patients by risk of malignancy to be referred in for intervention or managed locally, then helping interventionalists prioritize higher risk patients for prompt diagnostic intervention. Our first large cohort of primary care sales representatives were in the field for the full third quarter, and we've been encouraged both with the response from providers and with test adoption from their target accounts. Prior to the initiation of our primary care pilot conducted in 2024, only 4% of notified tests were ordered from primary care. In the short time this new effort has been in place, that number has increased to 11% in September. Overall, total tests ordered from primary care in the third quarter grew 75% over third quarter of 24. Last week, Dr. Susan Garwood, the National Physician Director for Pulmonology Service Line, Pulmonologist and Thoracic Oncology Medical Director for HCA Enterprise, conducted a national webinar on notified lung entitled, A Triage Tool Supporting Primary Care Referral Decisions. During the presentation, Dr. Garwood shared the early experience of a four clinic primary care practice that recently implemented notified lung testing to assess lung cancer risk across their large patient population. By implementing notified lung testing, they identified multiple patients with early stage lung cancer where curative surgery remained a viable option while avoiding unnecessary strain on bronchoscopy suite resources that would otherwise be required to evaluate dozens of patients. A recording of this webinar is available on our website. We continue to receive similar positive feedback and success stories from our team and directly from healthcare providers nationwide as we execute our strategy. We have also made significant progress in making it easier for clinicians to order and implement our test in their practices. In fact, one added benefit to our expanded sales strategy is the availability of on-site blood draw capabilities. This has historically been a challenge in pulmonology, where we frequently need to leverage our extensive mobile phlebotomy network to draw blood away from the office. Once a patient leaves the physician's office, we face the all too common challenge of patient compliance to ensure the blood draw is completed. Completing the blood collection onsite before a patient leaves the facility, either through onsite phlebotomy services or through our own capillary draw kits, resulting in more tests being delivered than if the patient leaves and needs to schedule a blood draw at another time. Ordering the test in the primary care setting and collecting the sample onsite helps to overcome this challenge. Similarly, electronic ordering streamlines the process and ease of use for the physicians in their office. Customer retention in those offices who utilize digital ordering is significantly higher than those who do not. Since notified launch, we've expanded our digital test ordering capabilities through our Biodesics physician portal and a number of early EHR integrations. Through these efforts, our digital ordering has increased by 43% over last year. In the third quarter, we had an average of 85 sales reps in the field who delivered 15,700 total lung diagnostic tests, up 13% year over year. We are continuing to execute on our stated strategy and plans and are expecting to have an average of 93 to 97 reps in the fourth quarter. Next year, we anticipate returning to a cadence of adding approximately six per quarter, continuing to drive patient access to cutting-edge diagnostic testing. In addition to our volume growth, our average revenue per test improved by 7% over the second quarter of 25. Due to our market access team's success in gaining more coverage and contracting for our tests, as well as process improvements and subsequent successes from our revenue cycle management team. In addition to our commercial efforts, we continue to generate clinical evidence to drive physician and payer adoption of notified testing. Two weeks ago at CHEST, which is the largest annual pulmonology meeting, we presented interim data from our CLARIFY study, new health economics and outcomes data, And there were multiple independent presentations and abstracts on Notify. Clarify is a retrospective chart review evaluating the use of Notify testing in real-world clinical practice, expecting to enroll approximately 4,000 patients. In the presentation, Dr. Michael Kammer, the head of AI and Radiomics at BioDesics, reviewed data on Notify CDT from the first 1,000 patients enrolled in the study. just one year after the study began. The data showed consistent performance of Notify CDT in a real-world setting versus prior clinical research with similar sensitivity and specificity. This study is an important addition to our existing evidence package for Notify testing, introducing data from a real-world environment that will continue to reinforce the clinical utility of Notify. The results from the independent analysis build on existing clinical evidence, showing the value of notified testing at independent practices across the country, the performance of the test in nodules detected in lung cancer screening programs, and showing that notified testing had superior performance as compared to PET scans. More data will be released in the coming months, including at the upcoming ISLAC ASCO North American Conference on Lung Cancer in December. Shifting to development services, we continue to see strong interest in our partnership service offering. We leverage our multi-omic approach and R&D expertise to help deliver insights that our biopharma, life science tools, and diagnostic partners use to personalize patient care and help improve disease detection and treatment decisions across various disease types. In the third quarter, we delivered $1.9 million in revenue growing 97% year over year. The funnel has also continued to grow with the team exiting the quarter with $12.9 million under contract but not yet recognized, representing a 16% increase over last year at this time and another all-time high. Moving to our product development pipeline and services partnerships, we had multiple presentations on our products in development at a number of medical and scientific meetings. Our current pipeline consists of our combination proteomic and genomic MRD test, expanded indications for Veristrat into several new tumor types with immunotherapy selection, and digital diagnostics. Multiple presentations on the MRD test were presented at the Tricon Precision Medicine Conference, the AACR Annual Meeting, and DDPCR World. Our unique MRD test combines the proteomic information from our risk of recurrence test that can give insights into a patient's immune profile, along with tumor-informed genomics that leverage the high sensitivity and specificity of multiplexed droplet digital PCR for disease monitoring. One exciting recent update is an expanded product development partnership with Bio-Rad Laboratories in which we will conduct the development, clinical validation, and regulatory submissions of certain high complexity in vitro diagnostic assays based on Bio-Rad's DDPCR technology. The first assay will be ESR1, which is becoming critical in HR-positive HER2-negative advanced breast cancer. We expect the partnership to expand, enabling highly sensitive and specific detection of additional genomic markers utilizing Bio-Rad's QX600 platform. This is another key partnership in addition to those already announced with Thermo Fisher Scientific and Memorial Sloan Kettering Cancer Center, and are examples of the strength of the Biodesics Development Services offering, including the conduct of assays under design control, quality management systems, regulatory and reimbursement support for in vitro diagnostics. Coming up on November 12th at the AMP annual meeting in Boston, representatives from Bio-Rad, Thermo Fisher, and Memorial Sloan Kettering will join a panel led by Dr. Gary Postano, our Chief Development Officer, to present on the Bioethics R&D developments, our unique and highly specialized partnerships with these premier institutions, and updates to the product pipeline. A recording will be available on our website following the event. Overall, we are very encouraged by the continued strong year-over-year growth in this business and believe there is significant potential for upside as both existing business and additional opportunities mature. Finally, turning to guidance, based on how we closed the third quarter and based on the momentum we're seeing early in the fourth quarter, we are comfortable increasing our revenue guidance range for 2025 to $84 to $86 million. With that, let me turn it over to Robin for review of our financial performance for the quarter. Robin?