2/26/2026

speaker
Operator
Conference Operator

Good day and thank you for standing by. Welcome to the Biodesics fourth 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 will 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 11 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker today, Chris Brinzey. Please go ahead.

speaker
Chris Brinzey
Investor Relations

Thank you, operator, and good afternoon, everyone. Today, Biodesics released results from the fourth quarter and fiscal year 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?

speaker
Scott Hutton
Chief Executive Officer

Thank you, Chris, and thank you all for joining 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 and 2026, we're focused on three main goals, growing top-line revenue, improving organizational effectiveness and operational leverage, and advancing our pipeline for future commercial growth and expansion. In the fourth quarter, we made progress on all three goals. Our top line growth accelerated with revenue up 41%. We improved upon already strong gross margins by 400 basis points to 83%. We achieved adjusted EBITDA positivity, and we presented real-world clinical data that continues to support the use of our on-market test 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 medical purpose. We've implemented a three-tier commercial strategy focused on improving the management of patients with lung nodules through the use of our on-market tests. This strategy started at the launch of notified lung testing with interventional pulmonologists, who are typically responsible for diagnosing lung cancer. We then expanded into their referral network in general and community pulmonology. In 2025, we selectively expanded further into the primary care referral network, allowing us to access the remaining 50% of the available nodule market being managed by those physicians. This approach enhances the value of notified lung testing by first helping general pulmonologists and primary care providers triage patients by risk of malignancy and deciding who should be referred for intervention or managed locally by surveillance, then helping interventionalists prioritize higher risk patients for prompt diagnostic intervention. We continue to see a positive response from our customers with this expanded sales strategy, resulting in strong growth from both pulmonology and primary care. In the fourth quarter, volumes from primary care accounted for 12% of the total notified test, growing 67% over the fourth quarter of 2024, and volumes from pulmonology growing 26%. In total for the fourth quarter, we had 97 sales representatives active in the field, delivering 18,000 tests or 23% growth. In our last earnings call, we told you about a recent webinar from Dr. Susan Garwood, the National Physician Director for the Pulmonology Service Line at HCA, the largest hospital system in the US. Dr. Garwood detailed her experience and successes with implementing notified testing in her referring primary care network. This experience is replicating across the country, with notified testing being utilized to help health systems identify cancers earlier and manage the sheer volume of patients with lung nodules through better triaging to either intervention or monitoring. In addition to growth in testing volumes, we continue to see improvements in average revenue per test that started to pick up in the third quarter. This is a result of our market access and revenue cycle management teams delivering additional coverage policies and improved claims collection, particularly for Notify XL2 and Notify CDT. On the development services front, we continue to see increasing interest in our distinctive offerings where 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. We announced two major partnerships to develop and validate tests as a center of excellence for Thermo Fisher Scientific and separately with Bio-Rad Laboratories. These partnerships are an important recognition of the strength and breadth of capabilities in our team to deliver high quality and rapid results for our partners. In December, at the Association for Molecular Pathology, or AMP, annual meeting, We were joined by collaborators from Memorial Sloan Kettering Cancer Center, Thermo Fisher, and Bio-Rad to present on these key partnerships and provide insights into portions of our product development pipeline. Today, our development pipeline consists of a unique MRD test that combines the proteomic information from our proprietary risk of recurrence test that provides insights into a patient's immune profile, along with tumor-informed genomics that leverages the high sensitivity and specificity of multiplexed droplet digital PCR for disease monitoring. It also includes expansion of the Varistrat test into immunotherapy selection in several new tumor types, including colorectal cancer, as well as another expansion of the Varistrat test for prostate cancer, predicting the likelihood of response to standard of care hormone therapy. We also have a new ESR1 genomic test, which is available to help guide treatment in breast cancer. And lastly, AI-based digital diagnostics that will initially supplement our current on-market tests in lung disease. You'll hear more about the new AI-based digital diagnostic test offering in the coming quarters. Throughout the course of 2025, we continued to generate, present, and publish real-world clinical and health economics data for our on-market and pipeline products. In order to help drive the adoption of our test by healthcare systems, healthcare providers, and payers, we published new clinical data and had multiple data presentations at a variety of physician society meetings. Our efforts were supplemented by data presentations from our partners and by a number of independent clinicians publishing on their own data on the real-world use of our test. To summarize, we finished 2025 strong with excellent fourth quarter performance, including accelerated revenue growth to 41%, delivered 83% gross margins, which are the strongest in advanced diagnostics, recognized significant improvements in reimbursement, achieved adjusted EBITDA positivity, generated strong clinical and real-world evidence for our on-market and pipeline products, announced additional key development partnerships, and increased the number of services, contracts, and customers utilizing our offering. With that, let me turn it over to Robin to review our financial performance and provide initial 2026 guidance. Robin?

Disclaimer

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