Biodesix (NASDAQ:BDSX) executives used a presentation at the William Blair Growth Stock Conference to highlight first-quarter revenue growth, progress toward profitability and the company’s commercial strategy for its lung cancer diagnostic testing portfolio.
Chief Executive Officer Scott Hutton said the company delivered “greater than 40% revenue growth” in the first quarter and continues to generate gross margins above 80%. He said Biodesix has guided to full-year revenue of $108 million to $114 million and expects to achieve profitability during the fiscal year.
Commercial Strategy Focuses on Lung Nodule Testing
Chief Commercial Officer Kieran O’Kane said Biodesix’s current growth strategy is centered on execution with the company’s existing tests, particularly its Nodify Lung portfolio. He described Nodify Lung as the company’s “primary growth driver” and said the business is built around the pulmonologist as the key call point for lung disease.
Biodesix has five on-market tests that span the point of lung cancer diagnosis, O’Kane said. Three proprietary tests have Advanced Diagnostic Laboratory Test, or ADLT, status, which he said provides more control and protection on pricing.
Vice President of Marketing Robbie Lunt said lung nodule risk stratification is the company’s core commercial focus within lung cancer. He said 5 million to 6 million patients each year present with newly detected lung nodules, with the major clinical challenge being to identify the roughly 5% of patients who have or will develop lung cancer while avoiding unnecessary procedures for others.
Lunt said delays in nodule management can affect outcomes, citing recent studies showing that up to 43% of patients upstage between nodule discovery and later referral or treatment. He said Biodesix’s tests are intended to help move higher-risk patients more quickly through the care pathway while allowing lower-risk patients to be monitored.
Primary Care Expansion Seen as Addressable Market
O’Kane said Biodesix initially focused on pulmonary thought leaders and procedural pulmonologists to build advocacy for Nodify testing. The company then used those advocates to educate referral networks, including both community pulmonologists and primary care physicians.
He said Biodesix later used claims data to refine its view of the primary care market. While there are more than 250,000 primary care physicians in the U.S., O’Kane said about 15,000 manage roughly 80% of pulmonary nodules, making the segment more addressable for the company.
Biodesix has divided the U.S. into 50 sales territories, O’Kane said. Each territory is anchored by a pulmonology sales consultant, with account managers, associate sales consultants and general practice sales consultants added based on business needs and opportunities.
Testing Portfolio Targets Different Nodule Sizes
Lunt said Biodesix’s tests are designed to address different clinical needs based on nodule size. For larger nodules, the tests are aimed at prioritizing and triaging patients so specialty resources can focus on those at highest risk. For smaller nodules, where clinicians may otherwise wait and monitor patients over time, Lunt said the tests are designed to identify patients who should receive closer attention or faster specialist referral.
He also described a data visualization tool Biodesix uses to show how Nodify testing changes patient risk assessment before and after testing. Lunt said the tool has been expanded to show changes in clinical decision-making, including what physicians planned to do before testing and how results informed treatment plans.
Lunt said Biodesix has published evidence on its tests for more than 10 years. He highlighted a recent clinical validation study published in Future Oncology, which he described as the largest clinical validation study for a lung nodule biomarker. He also discussed the CLARIFY study, a retrospective chart review of commercially tested patients. The company’s goal for CLARIFY is 3,000 to 4,000 patients, and Lunt said the study has enrolled nearly 2,000 patients in under 24 months.
Executives Cite Market Expansion Opportunities
O’Kane said about 90% of lung nodules are found incidentally, often when imaging is performed for another reason, while about 10% are found through screening. He said lung cancer screening penetration is likely in the mid-teens, with about 15% of eligible patients receiving low-dose CT screening.
O’Kane said Biodesix views blood-based early detection tests and artificial intelligence tools layered on top of CT scans as potential market expanders. He said these technologies could increase the number of patients funneled into screening and improve nodule detection, expanding the addressable market for Nodify testing.
Financial Outlook
Chief Financial Officer Robin Harper Cowie said first-quarter revenue grew 42% year over year, driven by physician and patient reach, test volume growth and improved reimbursement. She said test volumes increased 29% and lung diagnostic revenue rose 37% in the quarter.
Harper Cowie said Biodesix reported an 82% gross margin for the quarter, marking several consecutive quarters above 80%. She said gross margin improved by 300 basis points year over year, helped by reimbursement, average revenue per test and operating efficiencies.
She also said the company saw a 35% improvement in adjusted EBITDA and improvements in net loss. Biodesix reiterated that it expects to reach cash flow positivity by the end of the year and said its full-year revenue guidance of $108 million to $114 million represents about 25% year-over-year growth.
About Biodesix (NASDAQ:BDSX)
Biodesix, Inc is a commercial-stage molecular diagnostics company headquartered in Boulder, Colorado, that develops and delivers blood-based tests to improve the diagnosis and management of lung diseases, including lung cancer. The company integrates advanced proteomic and, more recently, genomic technologies to offer noninvasive testing solutions designed to guide clinical decision-making. Biodesix operates a CLIA-certified and CAP-accredited laboratory, allowing it to process patient samples at scale and maintain rigorous quality standards.
The company’s flagship product, VeriStrat®, is a proteomic test that stratifies patients with non-small cell lung cancer into groups more likely to benefit from specific therapies.
