Scott Hutton
Analyst · William Blair. Your line is open
Thank you, Chris. As a reminder, Biodesix is a patient-centric, mission-driven lung disease diagnostic company with a mission to unite biopharma, physicians and patients to transform the standard of care and improve outcomes with personalized diagnostics. In our last call in May, we were excited to share that towards the end of the first quarter, we were experiencing strong sales growth in our core lung diagnostic testing, driven in part by sales access returning to pre-pandemic levels. I am thrilled to say that, that strength continued through the second quarter. We finished Q2 with total revenue of $11 million, which includes core long diagnostic testing revenue of $7.3 million, reflecting a very strong 52% year-over-year growth and 56% growth over the first quarter of this year. This was a record quarter in terms of revenue and delivered test volumes. As we begin to put many of the challenges of adapting to a post-pandemic world behind us, we are confident that this momentum will carry through the end of the year and beyond. Stepping back for a moment, we believe we have one of the most comprehensive suites of diagnostic test with 5 blood-based tests available to support clinical decision-making across the lung cancer continuum from initial risk assessment of lung nodules with Nodify lung testing strategy to post-cancer diagnosis treatment guidance and monitoring with the IQ lung testing strategy. The Nodify lung testing strategy consists of two blood-based proteomic tests; Nodify CDT and Nodify XL2, which are used by physicians to assess the risk of malignancy of a lung nodule. This helps prioritize higher-risk nodules for invasive diagnostic procedures while also helping avoid unnecessary procedures on very low-risk nodules. In June, we announced that Medicare began covering the Nodify CDT lung nodule test at a price of $649. This is a significant milestone for Biodesix and ensures access and availability to Nodify testing for patients with lung nodules. Last year at this time, we had 4 tests, 3 of which were covered by Medicare. Just one year later, we’ve not only launched a new test, but we have Medicare coverage for all 5 diagnostic tests. Overall, as physicians gain more experience with our Nodify lung testing strategy, we continue to receive positive feedback reflected in increased adoption, which we believe demonstrates the clinical relevance and utility of these tests, and validates that we are only beginning to realize the full potential for Nodify lung to change the standard of care in lung nodule risk assessment. In addition, we also announced a collaboration with Philips to incorporate the Nodify lung test into the Philips Lung Cancer Orchestrator Patient Management System. We’ve observed a growing demand for digital integration in hospitals as an important factor to streamline logistics and create diagnostic efficiency by incorporating proteomics, radiologic, and patient history data in one place to support treatment decisions. We believe integrating our Nodify test into the Philips Lung Cancer Orchestrator will help facilitate digital ordering of the test following detection of a lung nodule with the ultimate goal of improving patient care and outcomes. As the integration progresses and rolls out, we will provide updates over the coming quarters. Moving to our IQLung test, we started the year with a full commercial launch of the GeneStrat NGS test, increasing our treatment guidance portfolio to 3 blood-based tests, including the GeneStrat-targeted ddPCR-genomic test and the VeriStrat proteomic test. Offered as options within IQ lung testing strategy, these tests are used to inform treatment decisions and monitor for the rise of resistance mutations while patients are on therapy. The addition of NGS testing means we can now offer physicians the option to detect a broader range of less common genetic alterations. The GeneStrat NGS test is still early in its product launch, but we’re pleased with the feedback and interest not only in the GeneStrat NGS test, but also the full portfolio of IQLung treatment guidance testing. We continue to support and invest in data generation to demonstrate and reinforce the clinical utility of our test as well as looking to sign meaningful collaborations to further drive adoption and growth of our entire core lung diagnostic testing suite. For example, in May, we presented a poster assessing the impact of the Nodify XL2 test in a real-world clinical setting at the American Thoracic Society International Conference. Data presented highlighted the impact of the Nodify XL2 test on clinical management decisions and investigators showed the Nodify XL2 test was able to support a decrease in chest imaging, outpatient clinic visits and additional invasive procedures without misclassifying the benign lung nodules. At the upcoming International Association for the Study of Lung Cancer, 2022 World Lung meeting this month, we will be presenting data demonstrating that the VeriStrat test is predictive of progression-free survival and overall survival in patients testing low or negative for PD-L1, when treated with immune checkpoint inhibitors. We know there is a need for additional testing beyond PD-L1 alone to better identify who is likely to respond to immunotherapy, and we believe this data shows that VeriStrat has the potential to play a role in this decision-making. Beyond this, we have multiple other clinical studies being conducted and we expect the upcoming full data readout and publication of our Oracle study of the Nodify XL2 test to further support our sales and reimbursement efforts for the test. Additionally, we look forward to providing further updates on our ongoing insight study for the IQLung testing strategy, the altitude study of our Nodify testing and the BEACON study for primary immune response, our immunotherapy guidance test and our further development efforts for our pipeline risk of recurrence test. Moving to our biopharmaceutical partnerships and services business, we reported revenue of $0.7 million for the quarter, which continues to rebuild and rebound more slowly than we would like. While we are beginning to see enrollment pickup from the serious disruptions of the pandemic, we have seen numerous studies extended – we’ve continued to experience challenges in logistics delays in sample shipment and therefore, have not delivered on the timelines we originally anticipated. Yet, we continue to maintain a backlog of prospective and retrospective studies that we plan to work through over the rest of this year and into 2023. Adding to our confidence here is that we continue to receive positive feedback and interest in the Biodesix diagnostic Cortex proprietary AI and machine learning platform and our broad multimodal and multi-omic service offerings. Our ongoing efforts and advancements and explainability in transparent AI will provide unique insights and clarity to health care professionals and research teams by providing the ability and potential to identify key biological mechanisms driving specific outcomes for patient subgroups that may require a different approach or different treatment. Overall, we remain confident that in the near future, we’ll see growth in revenue from increasing demand for our service offerings. Lastly, we continue to look for ways to broaden our product offering, enabling us to capture a larger percent of the $29-billion total addressable market. In June, we announced a new research agreement with one of the top cancer centers in the U.S., Memorial Sloan Kettering Cancer Center and our existing partner, Bio-Rad Laboratories, to help develop a new novel minimal residual disease test. Also, we plan to utilize our array of genomics, proteomics, artificial intelligence and machine learning capabilities with the aim of developing additional biomarker assays in collaboration with MSK. We have said it before and cannot reiterate it enough. Lung cancer kills more people in the U.S. annually than the next three cancers combined and time matters when treating these patients. We pride ourselves on Biodesix’s ability to discover, develop, and commercialize a broad range of tests that can quickly provide critical results and insights back to health care professionals with best-in-class testing turnaround times for all of our tests to help improve patient care. With a comprehensive suite of tests, all with Medicare reimbursement and the ability to offer diagnostic solutions across the continuum of care, we believe we’ve just begun to scratch the surface of this $29 billion market opportunity and that we have both the team and the products to drive growth in 2022 and beyond. Now, let me turn it over to Robin to review the first quarter 2022 financial performance. Robin?