Biodesix — Third Quarter 2026 Earnings Summary

Financial Performance:

• Total revenue for the quarter ended September 30, 2026, was $24.0 million, representing a 10% increase year over year compared to $21.8 million.
• Diagnostic Testing revenue reached $23.0 million, a 16% year-over-year increase, driven by a 24% rise in test volumes to 19,400, partially offset by lower average revenue per test.
• Development Services revenue was $1.0 million, a decrease from $1.9 million in the prior year period.
• Gross margin remained flat at 81% compared to the prior year period.
• Operating expenses excluding direct costs were $25.5 million, a 3% increase year over year, including $0.9 million in non-cash stock compensation (a 19% decrease from the prior year).
• Net loss was $8.0 million, an 8% improvement year over year.
• Adjusted EBITDA loss was $3.9 million, a 16% improvement year over year.
• Cash and cash equivalents stood at $28.4 million as of September 30, 2026, a decrease of $1.6 million from June 30, 2026, which included $6.3 million in net proceeds from an at-the-market program.
• Deferred revenue decreased to $0.4 million from $1.0 million at the end of the prior year.
• Long-term notes payable net of current portion were $47.1 million as of September 30, 2026, compared to $47.4 million at the end of 2025.

Guidance and Future Outlook:

• Full-year 2026 total revenue guidance has been revised to $101 million to $103 million, with a midpoint representing approximately 15% growth over 2025.
• The company expects to continue progress toward profitability while maintaining gross margins of approximately 80% for the full year.
• Early fourth-quarter trends indicate accelerating new customer acquisition, continued growth across the established customer base, and broader physician engagement.
• October 2026 recorded the strongest month of new physician acquisition for the year.
• Commercial availability for the first radiomics-based lung nodule risk assessment test developed with Vanderbilt University is anticipated in 2028.

Business Segments and Product Lines:

• The lower average revenue per test in the Diagnostic Testing segment was primarily attributable to a larger percentage of total lung test volume from Nodify CDT.
• The company expanded its Lung Diagnostics portfolio strategy by adding Digital Diagnostics, establishing a multimodal platform combining blood-based biomarkers, imaging biomarkers, and artificial intelligence.
• Two complementary molecular residual disease (MRD) monitoring programs were announced: a tumor-informed assay developed with Bio-Rad Laboratories and a tumor-naïve, methylation-based assay under development with Thermo Fisher Scientific.
• Both MRD programs are being validated with investigators at Memorial Sloan Kettering Cancer Center and utilize a hybrid model combining a central lab with distribution on partner platforms.

Market and Competitive Landscape:

• The American College of Chest Physicians (CHEST) published a framework identifying validated biomarker testing, such as Nodify Lung® Risk Assessment Testing, as a core component of standardized risk stratification in lung nodule programs.
• Real-world evidence presented at CHEST 2026, including analyses from the CLARIFY study of over 2,000 patients, supported the integration of Nodify Lung® into routine nodule care.
• The framework represents further recognition of biomarker-guided risk stratification supporting broader adoption by health systems and integrated care networks.

Risks and Challenges:

• Growth was below expectations due to fewer contributing sales representatives than planned, limiting new physician and account growth.
• Greater-than-anticipated seasonality, primarily in primary care, impacted results.
• Reduced ordering frequency among otherwise stable base customers affected performance.
• Delays in external customer dependencies postponed the start of Development Services projects and associated revenue recognition.
• Management noted these factors were largely execution and timing related rather than a change in demand, clinical utility, or market opportunity.

Management Commentary and Tone:

• CEO Scott Hutton stated the company delivered another quarter of year-over-year growth but acknowledged growth was below expectations.
• Management indicated they have identified the drivers of the quarter, taken corrective actions, and entered the fourth quarter with a larger sales organization positioned for improved execution.
• Management believes Biodesix is positioned to enter 2027 from a stronger strategic position than ever before due to progress in lung diagnostics and corrective actions.

Other Key Points:

• The company raised its share count from 8,253,053 shares in December 2025 to 11,054,674 shares as of September 30, 2026.
• Stockholders' equity turned positive to $8.7 million as of September 30, 2026, compared to a deficit of $2.5 million in December 2025.
• The company announced the addition of Digital Diagnostics to its portfolio, with the first product designed to complement the Nodify Lung® portfolio.
• The MRD programs are designed as hybrid programs combining a central lab model with distribution on partner platforms installed in laboratories globally.