3/14/2022

speaker
Operator
Conference Call Operator

Ladies and gentlemen, thank you for standing by, and welcome to the Biodesic's fourth quarter and full year 2021 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 need to press star 1 on your telephone. If you require any further assistance, please press star 0. I will now turn the call over to your host, Christopher Nz. You may begin. Thank you.

speaker
Christopher Nz
Host

Thank you, Operator, and good morning, everyone. Thank you for joining us today for a discussion of Biodesic's fourth quarter and year-end 2021 business highlights and financial results. Meeting 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 and financial results for the fourth quarter and year-end 2021. A copy of the release can be found on the investor relations page of the company website. Actual events and 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 risks Factors section and elsewhere in the company's annual report on Form 10-K for the year ending December 31, 2021, filed with the Securities and Exchange Commission 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?

speaker
Scott Hutton
Chief Executive Officer

Thank you, Chris. As a reminder, Biodethics is a patient-centric 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. 2021 was another unprecedented year with multiple COVID waves throughout the year impacting access to physicians and shutting down hospitals. The Biodesics team would like to thank all healthcare professionals who have and continue to work tirelessly to help every patient. We all know how difficult and challenging that job is and how the pandemic has made it even more complex. Despite the headwinds and obstacles from COVID, we're pleased with the performance and results delivered by the Biodesics team. I believe our accomplishments and successes in 2021 speak volumes about our team, mission, vision, and culture, as well as the value our tests provide physicians and healthcare professionals who use the key critical test results and insights to positively impact their patients. Throughout the year, as we saw and experienced the ebbs and flows of the pandemic, the Biodesics team continued to lead and focus on strategic commercial execution. We continued to focus on expansion of our direct dedicated sales team growing from 24 sales team members to 48 sales team members by year-end. Increasing our commercial footprint is critical to our continued growth and development. These 48 sales team members sell our broad portfolio of five blood-based lung diagnostic tests. The testing portfolio begins with the Notify XL2 and Notify CDT tests, which are used for lung nodule management. Not only did we see and experience significant growth in the number of physicians ordering and using these tests, but we also shared data on Notify XL2 in October from our prospective Oracle Clinical Utility Study at the 2021 CHEST Annual Meeting. The goal of the study was to demonstrate that incorporating this blood-based test into the management of patients with newly detected lung nodules could modify how physicians treat patients while improving outcomes. The results successfully demonstrated that the NOTIFY XL2 test was able to reduce the number of invasive procedures on benign nodules by 67%, which supported and reinforced the data presented and published from the panoptic study. In summary, the data highlights the importance of being able to provide a simple blood-based test that can rapidly reclassify a nodule as low risk for the patient providing confidence in a wait-and-watch approach supported by serial CT scans. And for the health system, as they focus on avoiding unnecessary, invasive, and costly procedures. We expect this and additional data from this study will publish in 2022. In the lung continuum of care, after a patient has been diagnosed with lung cancer, the Biodesic sales team members offer three blood-based tests for treatment guidance and monitoring, the proteomic varistrat test, the targeted genomic genistrat DDPCR test, and our new broad genomic genistrat NGS test. In 2021, the biodiesel team made incredible progress that enabled us to introduce the new genistrat NGS test earlier than planned. In November 2021, we initiated a limited commercial launch and followed that with full commercial launch in January of 2022 with Medicare payment for the test already secured. When dealing with any disease, time matters. When dealing with the deadliest of all cancers in lung cancer, each and every day is critically important to the physician, the patient, and the patient's family. At Biodesics, we value time and fully appreciate its importance, which is why we take great pride in our 72-hour turnaround time for the new Genistrat NGS test. This complements the 36-hour turnaround time for Veristrat and Genistrat DDPCR and provides Biodesics with three tests for treatment guidance and monitoring with the fastest turnaround times available to physicians, better supporting their need and interest in getting patients on the right and best treatment as quickly as possible. On the biopharmaceutical partnership and service front, we increased the number of contracts and dollars under contract, including near-term retrospective studies that will be conducted over the coming quarters and longer-term prospective studies that will be conducted and recognized over the coming years as our partners enroll patients. Overall, prospective trials in our biopharma activities in this area are robust, and we remain confident that we'll continue to see further growth and expansion in coming quarters. Of note, we've received positive feedback and interest in the Biodesics Diagnostic Cortex, our proprietary AI and machine learning platform, including the unique capabilities that we publish mid-year and our broad multimodal and multiomic offerings. Our efforts and advancements in transparent AI will provide additional insights and clarity to healthcare professionals while 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. In 2021, the Biodesic sales team was innovative, flexible, and driven. In the third quarter, we noted that our sales team members were paying for themselves on average in four to six months, and including the COVID-19 challenge that continues to be the case today. Now let me turn it over to Robin to review the fourth quarter and year-end 2021 financial performance. Robin?

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