Biodesix, Inc.

Good day and thank you for standing by. Welcome to the Biodesics Q2 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 will need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Chris Brunze. Please go ahead.

Thank you, Operator, and good afternoon, everyone. Today, Biodesics released results from the second 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. Descriptions 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.

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 result in a positive adjusted EBITDA in the fourth quarter, and advancing our pipeline for future growth and expansion. In the second quarter, we made progress on all three by growing revenue by 12% year over year, improving our already strong gross margins by 150 basis points to 80% and presenting clinical data on multiple pipeline products. Starting with the clinical offering and lung diagnostics, our major focus is on lung nodule management where nodules are either found incidentally when the patient has an image taken for another purpose or during low dose CT screening for lung cancer. In our recent earnings calls, we've provided detailed information about our plan to expand our commercial sales efforts to better address gaps in care for patients with lung nodules. Throughout last year, a growing number of ordering pulmonologists provided important feedback, stating that ordering the Notify XL2 and Notify CDT test within their referral network would help optimize nodule management. If the tests are ordered earlier, those patients who are at higher risk of lung cancer should be referred on to the interventional pulmonologist, while lower risk patients may remain with the primary care physicians for monitoring. This feedback was instrumental in the formation and implementation of our territory-based sales strategy to engage both pulmonologists and their referral network, including primary care. In the first quarter, we implemented this change and reconfigured our sales team to 49 territories. Each territory is anchored by a pulmonology sales rep with a mix of primary care sales reps and associate sales reps providing support in driving adoption in pulmonology and through their referral network. The specific combination of the sales roles in each territory is tailored to the local clinical need. We believe this approach allows us to directly address than nearly 50% of patients with lung nodules currently being managed by primary care physicians outside of pulmonology. In the second quarter, we completed training of our first full class of primary care sales reps who entered the field in late June. While the first full class has only been in the field for a few weeks, the response from primary care physicians has been encouraging. with physicians recognizing the clinical need and the benefits of improved lung nodule risk assessment with notified testing. Prior to the initiation of our primary care pilot conducted in the second half of 2024, approximately 4% of notified tests were ordered from primary care. And as a result of our targeted efforts, that number has increased to approximately 9% in June. We're also working on ways to make it easier for clinicians to order and implement our test in their practices. In fact, one added benefit to our updated sales strategy is the availability of on-site blood draw capabilities within the primary care setting. This has historically been a challenge in pulmonology where we frequently need to leverage our extensive mobile phlebotomy network to collect blood samples for testing. 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 results in 30% more tests 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 address this challenge. In addition, 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 40% higher than those who do not. Since Notify launched, we've expanded our digital test ordering capabilities through our Biodesk Physician Portal and a number of early EMR integrations. Through these efforts, our digital ordering has increased by 63% over last year. In the second quarter, we had an average of 74 sales reps in the field who delivered 15,100 total lung diagnostic tests and just under $1 million in annualized revenue per sales rep. Looking forward, we expect to have an average of 83 to 87 reps in the field in the third quarter and 93 to 97 reps in the fourth quarter, allowing us to drive patient access to cutting edge diagnostic tests regardless of where they're being managed. In addition to our commercial efforts, we continue to build the book of clinical evidence supporting the use of our notified test. In the second quarter, health economic and outcomes research data supporting our test were presented at ISPOR 2025. And an independent study from a clinical user of the test was presented at ATS 2025. We are also continuing to make progress with our CLARIFY study, which is a retrospective chart review evaluating the use of notified testing in real-world clinical practice. This trial is expecting to enroll approximately 4,000 patients. Since launch of the study in late October 2024, we've already accrued over 1,100 patients and anticipate releasing interim data from the study in the second half of this year. Finally, we're pleased to provide an update on our prospective randomized clinical study altitude. The Data and Safety Monitoring Board met and determined that the study has enrolled a sufficient number of patients to reach statistical power and recommended that patient enrollment close. Patient enrollment closed in late July and now the investigators continue the mandated one-year patient follow-up to track outcomes. As the company is blinded to the data while the study is ongoing, we do not have any additional information on potential results but are pleased to see that the sufficient number of patients have been enrolled as we move to the next phase of follow-up. We will provide additional information on the study as it becomes available. Moving to our pipeline, we had multiple presentations on our products and development. 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 our MRD test were presented in April and May, including at AACR 2025. Our unique MRD test combines the proteomic information from our risk of recurrence test that can give insights into a patient's immune status, along with tumor-informed genomics that leverages the high sensitivity of droplet digital PCR for disease monitoring. At ASCO, new data was presented from the Prospective Registry Study Insight demonstrating the potential of the Veristrat test in helping to guide first-line immunotherapy treatment strategies in patients with non-small cell lung cancer and PD-L1 of greater than 50%. At ASMS, we share data on the use of the Veristrat test in identifying hormone treatment responses in men with metastatic castration-resistant prostate cancer. Finally, we will also share more data on the prognostic significance of Veristrat in multiple MSI-high solid tumors in patients eligible for treatment with Keytruda. These data will be presented by our collaborators at the upcoming ESMO meeting in the fall. Shifting to development services, we continue to see strong interest in our development services offering that leverages 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 second quarter, we delivered $2.1 million in revenue, growing 53% year over year. The funnel has also continued to grow, and we exited the quarter with $12.5 million under contract representing a 54% increase over last year at this time and an all-time high. In early July, Thermo Fisher announced their new NGS assay received FDA approval as a companion diagnostic. The announcement recognized Biodesics as a key collaborator in the validation of the test. This partnership and approval are key examples of the strength of the Biodesics development services offering, including the test discovery and development, clinical trial testing, and regulatory support for companion diagnostics. We look forward to providing further updates on additional progress with Thermo Fisher and this initiative. Overall, we are very encouraged by the continued strong year-over-year growth in this business and believe there is significant potential for upside. With that, let me turn it over to Robin to review our financial performance for the quarter. Robin?