Biodesix (NASDAQ:BDSX) said its commercial expansion, broader primary care outreach and recently published clinical data supporting use of its Nodify CDT test in smaller lung nodules are among the principal drivers of its growth strategy.
Speaking at the Canaccord Genuity Growth Conference, Chief Executive Officer Scott Hutton said the company has five commercially available blood-based tests addressing lung cancer care, including two tests used before a cancer diagnosis to help assess whether lung nodules are more likely malignant or benign. Biodesix also offers three tests intended to support treatment guidance and therapy selection following a cancer diagnosis.
Revenue Outlook and Path Toward Profitability
Biodesix reaffirmed its full-year revenue guidance of $108 million to $114 million, which represents approximately 25% year-over-year growth at the midpoint. Management also maintained its expectation of reaching positive adjusted EBITDA on a run-rate basis in the near term.
Hutton said the recent expansion of Nodify CDT testing to nodules measuring 4 millimeters to just under 8 millimeters was received well by physicians and could support continued growth during the second half of the year. The company is seeing adoption among both new and existing ordering physicians in pulmonology and primary care, he said.
Chief Financial Officer Robin Cowie said the company’s path to free-cash-flow break-even is heavily dependent on top-line growth, combined with operating cost discipline, improving sales-representative productivity and the contribution from newer representatives.
Biodesix reported gross margin of about 82% during the quarter and is guiding to gross margin near 80% for the full year. Cowie said maintaining margins in the low-80% range is viable over the long term, while the company continues to pursue laboratory-process improvements. Those operational projects have also expanded laboratory capacity, she said, leaving the company with years of capacity before it would require material investment beyond equipment refreshes.
Sales Force Expansion and Primary Care Adoption
The company had approximately 104 sales representatives in the field during the second quarter and expects to finish the year with about 120 contributing representatives. Hutton said Biodesix has generally hired six to eight sales professionals per quarter and currently plans a similar pace next year.
Management emphasized the need to balance faster hiring with profitability and salesforce effectiveness. Hutton said Biodesix expects to have strong market coverage by the end of next year, while retaining the ability to add resources when major accounts require additional support.
Primary care volume increased 133% year over year and represented approximately 15% of total volume during the past two quarters. Hutton said the proportion may fluctuate over time, but the company expects both primary care and pulmonology to continue growing. Pulmonology volume grew 31%, despite being a more mature commercial channel, he said.
According to Hutton, primary care physicians are generally familiar with ordering molecular diagnostics and often have on-site or adjacent blood-draw capabilities. Pulmonologists, by contrast, have required more education regarding how blood-based testing fits into their workflow, and Biodesix has had to build supporting phlebotomy capabilities in that channel.
Clinical Evidence and Reimbursement
Cowie said a study involving more than 1,000 patients supported the ability of Nodify CDT to identify patients more likely to have malignant disease in smaller nodules without a significant increase in false positives. The study was published late in the first quarter, and management said it generated increased physician demand both for smaller nodules and across broader eligible patient populations.
The company also cited growth in tests ordered per physician following adoption of the test. Management said this pattern has been consistent across both primary care and pulmonology.
Biodesix said average revenue per test improved year over year, aided by new coverage policies and contracts for Nodify CDT, Nodify XL2 and VeriStrat. Cowie said Nodify XL2 carries a higher price point and therefore makes a larger contribution to revenue, although payer adoption has been consistent across both Nodify tests.
Management said it continues to pursue private-payer contracts with the goal of maintaining consistent patient access and payment rates across payer groups.
Pipeline, Studies and Market Opportunity
Hutton said Biodesix plans to provide a research-and-development update around the AMP meeting in November. Its pipeline work includes risk-of-recurrence, minimal residual disease, VeriStrat and potential applications beyond lung cancer. The company is collaborating with Memorial Sloan Kettering Cancer Center, which provides clinical data, patient outcomes and samples, while Biodesix contributes testing expertise and equipment.
The company expects to begin publishing findings from its INSIGHT VeriStrat study, which included more than 5,000 patients, around next year’s ASCO meeting. Biodesix also discussed its CLARIFY retrospective study, which has enrolled more than 2,000 patients who received Nodify testing and have at least one year of follow-up.
Management said CLARIFY analyses are intended to reinforce clinical utility and potentially broaden use of Nodify testing. Areas under evaluation include comparisons with PET scans, time to diagnosis and whether Nodify use may help identify cancer at earlier stages.
Hutton said the company sees minimal incremental infrastructure investment required to commercialize additional products because of its existing quality systems, laboratory capabilities and lung-focused commercial organization. While he described minimal residual disease as a potentially significant market opportunity, he said it would not be a meaningful contributor within the next six to 12 months.
On competition, Hutton said Biodesix believes its intellectual-property portfolio, clinical evidence base and direct pulmonology salesforce are important differentiators. He also said broader adoption of single-cancer and multi-cancer early-detection testing could benefit Biodesix by bringing more screen-eligible patients into the care pathway, potentially leading to more CT scans and subsequent use of Nodify testing.
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.
