Exagen Inc.

Greetings, ladies and gentlemen. Welcome to the Exigen Incorporated Second Quarter 2021 Earnings Conference Call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during this conference, please press star zero on your telephone keypad. Please note that this conference is being recorded. I would now like to turn the conference over to your host, Ryan Douglas, Investor Relations for Exigen. Thank you. You may begin.

Good afternoon, and thank you for joining us today. Earlier today, Exogen Inc. released financial results for the quarter ended June 30th, 2021. The release is currently available on the company's website at www.exogen.com. Ron Rocca, President and Chief Executive Officer, Kamala Dowie, Chief Financial Officer, and Mark Hazeltine, Chief Operating Officer, will host this afternoon's call. Before we get started, I'd like to remind everyone that management will be making statements during this call that include forward-looking statements within the meaning of federal security laws, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Any statements contained in this call that are not statements of historical facts should be deemed to be forward-looking statements. All forward-looking statements, including without limitation, statements regarding our business strategy and future financial and operating performance, including 2021 guidance, the impact of COVID-19 pandemic on our business, our current and future product offerings, and reimbursement and coverage are based upon current estimates and various assumptions. These statements involve material risk and uncertainties that could cause actual results to differ materially from those anticipated or implied by these forward-looking statements. Accordingly, You should not place undue reliance on these statements. For a list and description of the risk and uncertainties associated with our business, please see our filings with the Securities and Exchange Commission, including our Form 10-K for the year ended December 31, 2020, and subsequent filings. The information provided in this conference call speaks only to the live broadcast today, August 9, 2021. Exogen disclaims any intention or obligation, except as required by law, to update or revise any information, financial projections, or other forward-looking statements, whether because of new information, future events, or otherwise. I will now turn the call over to Ron Rocca, President and CEO of Exygen.

Thanks, Ryan, and thank you to everyone joining the call today. As always, we appreciate your continued support of Exygen. The second quarter, 2021, was a record-breaking quarter for Exygen. We are incredibly proud of what we have achieved to enhance Exigent's position as a leading provider of autoimmune testing solutions. We achieved several records in the quarter, including delivery of 33,328 tests. This represents three record demand quarters in a row, which we believe demonstrates the momentum that the Advise brand has experienced even in the face of a pandemic. We also achieved records of 1,000 934 total ordering healthcare providers, and 703 adopters for our flagship Advise CTD and Advise Lupus test. This in turn equates to a record revenue quarter for XGen with total revenues coming in at 12.8 million. Once again, we saw a high retention rate of 99% among adopting healthcare providers from the prior quarter. We believe this high retention rate and the increase in the number of ordering healthcare providers speaks volumes to the value our customers recognize in using advice testing to accelerate the historically slow and frustrating process of clinically diagnosing autoimmune disorders. We continue to increase our investment in our R&D pipeline through a multifaceted approach, including clinical studies, collaboration with industry thought leaders, and the expansion of our laboratory. We are pleased with our July publication of an additional study demonstrating real-world evidence in the Lupus Science and Medicine Journal. The study shows that advised lupus demonstrates statistically significant clinical utility in achieving a definitive systemic lupus erythematosus diagnosis and positively impacts treatment decisions. We believe this study adds additional validity to our dossier and expect it to strengthen our position even further with payers. We recently signed an exclusive licensing research collaboration agreement with Allegheny Research and Autoimmune Institute, which allows us to focus on developing novel patented biomarkers for diagnosing, prognosing, and monitoring of autoimmune diseases, including lupus. This strategic partnership gives us access to intellectual property, key thought leaders in the autoimmune space, and a world-class biobank which we believe will benefit the clinical validation of both existing and future pipeline products. We couldn't be more excited about this partnership as it shows us to further develop our pipeline with some of the top minds in the autoimmune space. I want to turn your attention to a few studies that we have in progress. We have a prospective fibromyalgia study called the BETTER study, which is progressing at multiple sites with key opinion leaders. There are approximately 12 million people suffering from fibromyalgia, which presents clinically with similar signs and symptoms as lupus, but requires very different treatments. Helping these patients get diagnosed correctly can improve their quality of life while living with this chronic disease. With the better study, we are evaluating the effectiveness of combining CBCAPs with vibrational spectroscopy and metabolomic analysis to provide what could be the first rule-in, rule-out diagnostic tests for fibromyalgia. We intend to utilize the data from the BETTER study to launch our commercial fibromyalgia test in late 2023. We also have multiple thrombosis studies in progress, which we anticipate completing during the second half of next year. As many of you know, cardiovascular thrombotic events are a leading cause of death in lupus patients. We are developing our thrombosis test to accurately identify lupus patients at greater risk for cardiovascular thrombotic events and provide physicians an opportunity to intervene before such events occur. Depending on the results of this study, we plan on launching the thrombosis test in mid-2023. In the second half of 2021, we began the conversion of approximately 8,000 square feet of warehouse space into our existing clinical laboratory. We are also converting approximately 6,000 square feet of warehouse space into a dedicated research and development lab. The expansion of our clinical and R&D labs are expected to allow us to enhance our testing capacity, improve our efficiencies, develop molecular and multi-omic capabilities, and advance our pipeline products. We remain committed to the strategy of providing an integrated testing and therapeutic model. the opportunity and ROI with Symphony has diminished with the ongoing pandemic. We have mutually agreed to end our co-promotion agreement with Janssen for Symphony, effective August 31, 2021. As mentioned previously, we continue to invest in prioritization of our testing franchise, including payer coverage, pipeline products, and furthering partnership opportunities. Our Q2 performance in terms of record revenue, record advice CTD tests delivered, Record ordering healthcare providers, record adopters, as well as our investment in our pipeline gives us confidence that we are set up for long-term success. Our footprint with rheumatologists, hospital systems, and payers across the country continue to expand in Q2. As many of you know, autoimmune disorders are notoriously difficult and time-consuming to diagnose using traditional testing. Our CBCAPS technology offers the promise of faster, more accurate diagnosis, enabling earlier intervention in treating these chronic and sometimes deadly disorders. Before turning the call over to Kamal, I'd like to take a moment to welcome both Frank Stokes of Castle Biosciences and Anna Hooker of Exact Sciences to our board of directors. We are thrilled to have these industry experts join our board and contribute to our success. I will now turn over the call to Kamal to discuss our financial results.