Biodesix, Inc.

Good afternoon, ladies and gentlemen, and welcome to the Biodesics Fourth Quarter 2020 Financial Results Conference Call. At this time, all participants are in listen-only mode. A question-and-answer session will follow our prepared remarks today. If anyone should require operator assistance during a conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. I would now like to turn the conference over to Jeremy Pfeffer of LightSight Advisors. You may begin.

Thank you, Operator, and good afternoon, everyone. Thank you for joining us today for a discussion of BioDesign's fourth quarter and full year 2020 financial and operating results. Leading the call today will be Scott Hutton, Chief Executive Officer. He will be joined by Robin Harper-Calley, Chief Financial Officer. After the prepared remarks, we will open the call for Q&A. An audio recording and webcast replay for today's conference call will also be available online as detailed in the press release announcement for this call. For the benefit of those who may be listening to the replay or archived webcast, this call is being held and recorded on Tuesday, March 16th, 2021. Today, we issued a press release announcing our financial results for the fourth quarter and full year 2020, including our recent business highlights. A copy of the release can be found on the investor relations page of the company website. Actual events or results may differ materially from those projected as a result of changing market trends, reduced demand, and the competitive nature of biodesic sector. Such forward-looking statements and their implications involve known and unknown risks, uncertainties, and other factors that may cause actual results or performance to differ materially from those projected. The forward-looking statements discussed on this call are subject to other risks and uncertainties, including those discussed in the risk factors section and elsewhere in the company's annual report on Form 10-K for the quarter ended December 31, 2020, filed today. Additional information concerning factors that could cause results to differ materially from our forward-looking statements are described in greater detail in the company's press release issued today and in the company's filings with the SEC. I would now like to turn the call over to Scott Hutton, Chief Executive Officer. Scott?

Thank you, Jeremy, and thanks to everyone for joining Biodesic's first earnings call since becoming a public company. By all accounts, 2020 was an incredible year for Biodesic. The challenges brought about by the global pandemic seemed to bring out the best in the Biodesic team. The company launched three new tests and services, including Notify CDT and COVID DDPCR antibody and antigen testing services. We initiated new clinical trials, expanded our pipeline, publish new clinical data, and form new partnerships with biopharma companies and academic institutions. We also delivered record revenue of $45.6 million in 2020, which represented an 86% year-over-year growth. And we completed an IPO in October that raised approximately $64 million and provides the financial means to execute on our ambitious growth strategy. The funds from the IPO enabled us to begin a large commercial expansion to capitalize on the untapped nodule management market, invest in our technology, and increase development of new tests that broaden our portfolio. As this is Biodethics' first quarterly earnings call, we thought it would be helpful to spend a few minutes describing our company. Biodethics is a patient-centric, mission-driven company. Our goal is to be the trusted partner that the world relies on for data-driven diagnostic solutions to improve patient outcomes while lowering healthcare costs. We do this by developing and offering tests that reduce the use of ineffective and unnecessary treatments and procedures. In so doing, we partner and collaborate with physicians and biopharma companies to address those critical unmet needs. Our focus is solving complex diagnostic challenges in lung disease and for our biopharma partners. a U.S. market opportunity that we estimate is greater than $29 billion. By combining multiple technologies with a holistic view of each patient's immune response, our diagnostic test provides physicians with greater insights to help personalize their patient's care and meaningfully improve disease detection, evaluation, and treatment. Today, we're proud to offer six commercially available diagnostic tests for lung disease with best-in-class turnaround times. we continue to leverage our proprietary AI platform to develop additional tests for our commercial pipeline and companion diagnostics for our biopharm partners. We believe there is a critical clinical need to help physicians reclassify risk of malignancy in patients presenting with suspicious lung nodules. We offer the blood-based notified lung nodule risk assessment testing strategy to aid physicians in stratifying patients into two distinct nodule management treatment pathways, diagnostic procedures or imaging surveillance. Notify lung testing consists of two blood-based proteomic tests, the Notify CDT test, which helps identify patients with lung nodules that are likely malignant or higher risk of cancer, and the Notify XL2 test, which conversely helps identify those patients with lung nodules that are likely benign or lower risk of cancer. Currently, there are no other tests addressing this need in the marketplace. There's an imminent need for a blood-based testing solution that measures tumor-specific mutations and the patient's immune profile to provide physicians with more comprehensive information to assure the overall prognosis of the patient and personalize every patient's treatment plan. To that point, we offer the blood-based biodeflex lung reflex testing strategy, which consists of the Genistrat genomic tumor profiling test, and the Veristrat proteomic immune profiling test for patients diagnosed with non-small cell lung cancer. With a 72-hour turnaround time, we're able to quickly provide critical diagnostic information to physicians to facilitate personalized treatment decisions for their patients. During 2020, we expanded our offering by launching the NotifyCBT test, COVID-19 DD-PCR and antibody tests and related services. To address patient needs, we expanded our mobile phlebotomy network, resulting from an increased use of telehealth services. We've also expanded our COVID service offering by performing on-site rapid antigen testing for schools, athletics, and employers to quickly identify presumptive positive cases, coupled with high-accuracy PCR testing for confirmation and validation of cases through our customizable WorkSafe COVID-19 testing program. As a data-driven company, we're continuously adding to the body of evidence demonstrating the value of our test. Over the last quarter or so, we published two-year outcomes data for our Notify XL2 test, data from our patented blood collection device, and presented new data on Notify XL2 and CDT, Veristrat, and our primary immune response test from our pipeline. These publications, posters, and abstracts are providing more data to help support clinical adoption and reimbursement for our product. We launched two new studies, including the Altitude Clinical Utility Study, which is designed to further demonstrate the efficacy and performance of Notify XL2 and Notify CDT in a first-of-its-kind, rigorously designed, randomized, controlled study. We're grateful to Dr. Gerard Silvestri of Medical University of South Carolina for acting as principal investigator. And we look forward to sharing data from this important study. The second study is the Beacon Lung Clinical Study launched in partnership with Alchemy to prospectively evaluate the performance and utility of our primary immune response test in patients with advanced stage lung cancer. We also partner with biopharma companies to provide research, clinical trial testing, and new companion diagnostic discovery and validation. We recently announced one such partnership with HyperCell, a biotechnology company developing novel therapeutics for cancer relapse and metastasis with a focus on breast cancer. The partnership is for the development of a companion diagnostic to be used in future registrational breast cancer trials of its lead clinical asset, M'PGG. which will also emerge from our AI platform, will further strengthen our position as a leader in clinical proteomics by allowing for the selection of patients eligible for and likely to benefit from M-prime PGG therapy. Now let me turn it over to Robin to discuss our financial results. Robin?