8/5/2026

speaker
Operator
Conference Operator

Good day and thank you for standing by. Welcome to the BioDesix Q2 2026 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'll need to press star 11 on your telephone. You will then hear an automated message advising that 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
Moderator

Thank you, operator, and good afternoon, everyone. Today, Biodesix released results from the second quarter of 2026. Leading the call today will be Scott Hutton, Chief Executive Officer. He's 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 biodesix.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. Scott?

speaker
Scott Hutton
Chief Executive Officer

Thank you, Chris, and thank you all for joining today. I'm proud to share that the Biodesix team delivered another quarter of strong growth, expanding margins, and improving operating leverage, reflecting the strength of our commercial strategy as we continue to progress towards profitability. In the second quarter, total revenue was $26.9 million, representing 34% growth year over year, accompanied by strong operating discipline and execution. Starting with our diagnostic testing business, revenue grew 42%, driven by accelerating test volume growth and improved ASPs over the second quarter of 2025. Total test volumes grew 38% year-over-year due to increased adoption from both primary care and pulmonology, which grew 133% and 31% over the prior year respectively. We're pleased with the growth from both primary care and pulmonology, not only from new physicians beginning to order the Notify CDT and Notify XL2 test, but from increases in the number of patients tested from existing accounts. As a reminder, since the second quarter of last year, we've been ramping our efforts in the primary care market to address the approximately 50% of nodules that are managed by general practitioners. We've seen strong demand for notified testing in patients with smaller lung nodules. This population carries an inherently low risk of malignancy, but early detection of cancers significantly improves patient outcomes. Demand accelerated through the quarter following publication in March of the largest lung nodule biomarker validation study to date, which demonstrated that notified CDT can detect cancer in nodules as small as four millimeters while maintaining a low false positive rate. This clinical evidence drove a significant increase in notified CDT orders in smaller nodules during the quarter. Importantly, adoption within this patient population is also expanding utilization across the broader lung nodule continuum. Healthcare professionals who begin ordering notified CDT for smaller nodules subsequently increased their use of both Notify CDT and Notify XL2 for patients with larger nodules. We are seeing this pattern consistently across customer segments, including both primary care and pulmonology. In addition to the publication at the end of the first quarter, we continue to present and publish clinical data for our on-market test. In May, at the American Thoracic Society, or ATS, annual meeting, Real-world clinical and economic data was presented, including an independent study showing an increase in stage one lung cancer detection after the implementation of a lung nodule program using notified lung testing systematically to guide clinical decisions. Two others highlighted the role of notified lung testing to overcome limitations with PET scans for nodule evaluation. The presentations at ATS continue to highlight the real-world clinical value and economic advantages of lung nodule management programs that use Notify lung testing for risk stratification. This growing body of clinical evidence is driving deeper account penetration and increasing test utilization. The result is continued commercial expansion of the Notify franchise and further validation of its role in addressing the significant unmet clinical needs. As we are growing our top line, our team's ongoing operational focus continues to yield improvements in gross margin and operational leverage. We delivered our fifth consecutive quarter of gross margins at or above 80%. Our total revenue grew 34%, and operating expenses excluding direct costs only grew 7%, which included the expansion of our commercial team. With that, let me now turn it over to Robin to review our financial performance. Robin?

Disclaimer

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