Ron Rocca
Analyst · Cowen and Company
Thanks, Ryan, and thank you to everyone joining the call today. As always, we appreciate your continued support of Exagen. The second quarter 2021 was a record-breaking quarter for Exagen. We are incredibly proud of what we have achieved to enhance Exagen'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 3 record demand quarters in a row, which we believe demonstrates the momentum that the AVISE brand has experienced even in the face of the pandemic. We also achieved records of 1,934 total ordering health care providers and 703 adopters for our flagship AVISE CTD and AVISE Lupus tests. This, in turn, equates to a record revenue quarter for Exagen with total revenues coming in at $12.8 million. Once again, we saw a high retention rate of 99% among adopting health care providers from the prior quarter. We believe this high retention rate and the increase in the number of ordering health care providers speaks volumes to the value our customers recognize in using AVISE 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 & Medicine Journal. The study shows that AVISE 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 Autoimmunity Institute, which allows us to focus on developing novelly 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 they chose 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 CB-CAPs with vibrational spectroscopy and metabolomic analysis to provide what could be the first rule in, rule out diagnostic test 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 multiomic capabilities and in advance our pipeline products. We remain committed to the strategy of providing an integrated testing and therapeutic model. However, the opportunity and ROI with SIMPONI has diminished with the ongoing pandemic. We have mutually agreed to end our co-promotion agreement with Janssen for SIMPONI 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 AVISE CTD tests delivered, record ordering health care 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 continued to expand in Q2. As many of you know, autoimmune disorders are notoriously difficult and time consuming to diagnose using traditional testing. Our CB-CAPs 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 Ana 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.