Biodesix, Inc.

Good day and thank you for standing by. Welcome to the Biodesic's first quarter 2021 earnings conference call. At this time, all participants are in 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 then 1 on your telephone keypad. Please be advised that today's conference may be recorded. If you require any further assistance, please press star then 0 to reach an operator. I'd now like to hand the conference over to your host today, Chris Brinzey, Investor Relations. Please go ahead.

Thank you, Operator, and good afternoon, everyone. Thank you for joining us today for a discussion of Biodesic's first quarter 2021 business highlights and financial results. Leading the call today will be Scott Hutton, Chief Executive Officer. He will be joined by Robin Harper-Cowie, 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. Today we issued a press release announcing our business highlights financial results for the first quarter 2021. 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 biodesics industry. 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 factor section and elsewhere in the company's annual report on Form 10-K for the year ended December 31, 2020, filed with the Securities and Exchange Commission on March 16, 2021. 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, Chris, and welcome everyone to Biodesic's first quarter 2021 earnings conference call. We were pleased with our operating and financial performance in the first quarter and believe we're off to a solid start in 2021. Beginning with a high-level overview of our financial performance, we reported record revenue of $28.9 million in the quarter, which represented year-over-year and sequential quarterly increases of 466% and 7% respectively. Robin will go into more detail, but this comes on the heels of another record quarter from our COVID-19 testing services revenue, which grew 8% over the fourth quarter of 2020. As many of you know, our COVID-19 offering was developed in response to the public health emergency and has been driven by the need for quality, rapid testing that could be delivered quickly and reliably. We were compelled to respond to the pandemic and our COVID-19 testing services quickly became a strong source of revenue growth for Biodesics. While the overall rate of testing in the U.S. is tapering off due to the availability of vaccines and readily available retail at-home testing options, we continue to work to support communities both locally and across the country by expanding our WorkSafe COVID-19 testing program. Biodesics continues to perform on-site rapid antigen testing for schools, athletics, and employers to quickly identify potential cases that are then reflexed to our highly accurate PCR testing for confirmation and validation. Over the last year, we nimbly addressed the evolving challenges of the pandemic and are proud that we continue to do so. Recently, we announced a partnership with Genscript Biotech to conduct performance verification in our laboratory and commercialize its CPAS SARS-CoV-2 neutralization antibody test. This is the first and only surrogate neutralizing antibody test with FDA EUA authorization. The current vaccines are highly effective at generating antibodies against the viral spike protein when administered as recommended. However, Despite significant research and clinical advances made to combat the SARS-CoV-2 virus, the emergence of new variants and community outbreaks are of continued concern. Neutralizing antibodies may specifically block the interaction between the receptor binding protein on SARS-CoV-2 and the host cell's membrane receptor protein, thereby preventing infection of the cell by the virus. In essence, the test has the potential to identify individuals who may have antibodies capable of preventing the virus from infecting the cells. We believe that the CPAS test could be important in understanding long-term protective immunity to SARS-CoV-2. This test is currently available for research and biopharma services work, and announcements about the commercial launch of the test in our WorkSafe program will be forthcoming. In many respects, our role in the global pandemic has increased the public's awareness of Biodesics and who we are, a trusted partner that the world can rely on for data-driven diagnostic solutions that improve patient outcomes, lower healthcare costs, and deliver results quickly with the goal of improving patient outcomes. Biodesics remains focused on our core business, which includes solving complex diagnostic challenges in lung disease and for our biopharma partners. This focus represents a large US target addressable market that we estimate is greater than $29 billion. We utilize multiple technologies, including genomics, transcriptomics, proteomics, and radiomics, and leverage our proprietary AI-based diagnostic cortex platform to discover innovative diagnostic tests for clinical use. The company has six diagnostic tests commercially available, each of which intends to solve complex diagnostic challenges in lung disease and provide best-in-class turnaround times while reducing cost by eliminating unnecessary tests and procedures. Our Notify XL2 and Notify CDT tests are used to assess the risk of lung cancer for patients presenting with lung nodules and to help physicians identify the most appropriate treatment pathway. Our Genistrat and Veristrat tests are ordered by physicians following diagnosis of lung cancer to measure the presence of mutations in the tumor in addition to the state of the patient's immune system to establish the patient's prognosis and help personalize treatment decisions. In our lung diagnostic testing, we were pleased to see our first quarter revenue increase both year over year as well as sequentially above the fourth quarter of 2020. This business does, however, continue to be adversely impacted by the global pandemic as pulmonologists have redirected time and efforts to treat patients with COVID, and they have limited clinic volumes. However, this quarter, we did begin to see a shift that suggests pulmonologists are beginning to see more non-COVID-19 patients and expect this to continue throughout the course of the year, barring additional spikes and changes in the pandemic. As we focus on the recovery and our growth expectations, we continue to invest in our sales infrastructure and remain on track to double the size of our direct and dedicated sales force in 2021. The expanded sales force will better allow us to reach more physicians and provide them with a portfolio of tests to provide personalized information on their patients. This information will aid the physician in making educated decisions to direct the right patient onto biopsy or surgery and help many more avoid unnecessary interventions and guide treatment decisions. One of the most exciting recent developments is our new liquid biopsy next-generation sequencing test. The test was shown in a recent publication to have an unprecedented 72-hour turnaround time, which is significantly faster than the 7 to 14 days it takes for other NGS tests on market. Time to treatment for patients with cancer is critical, and we strive to provide reliable blood-based tests as quickly as possible to support our physicians and their patients. The NGS test will complement the Genistrat DDPCR test and Veristrat proteomic test currently offered, with the expanded coverage of broader molecular markers. The 52-gene NGS test will be intended for use in patients diagnosed with advanced, late-stage, or recurrent cancer, while the targeted ala carte Genistrat DDPCR test measuring six genes individually can be used for identification of the select mutations in all stages of disease and for treatment guidance, recurrence monitoring, and detection of the development of resistance mutations over time. Over the last year, we've cut the turnaround time of Genistrat and Veristrat in half, from 72 hours to 36 hours, furthering our commitment to provide high-quality test results as quickly as possible. The NGS test has been available for research and clinical trial use since 2018, and we plan to launch the test for commercial use in the first half of 2022. We'll provide more details in the months leading up to commercialization. We also continue to support the use of our diagnostic test by adding to the body of evidence demonstrating their utility and value. This remains a key component to our business and drives both clinical adoption and reimbursement. In April, we announced three abstracts from multiple clinical studies on our primary immune response and varistrat test, which were presented at the 2021 Association for Cancer Research Annual Meeting. These abstracts reflect our commitment to continual research and address the utility of physicians utilizing blood-based proteomic testing as an approach to support their treatment decisions with the ultimate goal to improve patient outcomes. We also partner with academic institutions, biopharma, technology, and diagnostic companies to provide research, clinical trial testing, and new companion diagnostic discovery and validation services. With significant ongoing partnership and research activities at Biodethics, we will continue to strengthen and broaden our position in the market, executing a deliberate patent strategy. We recently announced the issuance of two new patents that enhance our ability to develop blood-based immunotherapy and pipeline testing strategies. Patents have historically driven the biotechnology industry forward, but conversely have become more difficult than ever to obtain. Our recent issuances across diverse technology fields is good news in light of the increasingly fast-paced diagnostic sector. These developments further improve Biodesic's ability to develop and commercialize rapid and accurate diagnostic testing to support physician treatment decisions and strategies for their patients. Now let me turn the call over to Robin to discuss the first quarter financial performance.