Aurinia Pharmaceuticals(US:AUPH)2021-05-07 04:35Financial Data and Key Metrics Changes - As of March 31, 2021, Aurinia had cash, cash equivalents, and investments of $361 million, down from $423 million at December 31, 2020, primarily due to commercial infrastructure spending for LUPKYNIS launch [31] - The net loss for the quarter was $50.4 million, or $0.40 per share, compared to a net loss of $25.9 million, or $0.23 per share, for the same quarter in 2020 [33] - Revenues for the quarter were $1 million, up from $30,000 in the same quarter of 2020, attributed to the commercial sales of LUPKYNIS [33] Business Line Data and Key Metrics Changes - The launch of LUPKYNIS began after FDA approval in January 2021, with 257 patient start forms submitted in the first quarter, and a conversion rate of 40% by the end of March [10][18] - The gross margin for the quarter was approximately 95%, with cost of sales recorded at $48,000 [33] Market Data and Key Metrics Changes - Over 2,000 healthcare providers (HCPs) attended education programs about LUPKYNIS, and over 6,000 HCPs were engaged, representing 50% of the target universe [18] - Coverage for LUPKYNIS has been confirmed for more than 120 million lives, with 40% of these lives having no step-through requirements for coverage [20][74] Company Strategy and Development Direction - The company aims to establish LUPKYNIS as the standard of care for lupus nephritis (LN) and is focused on increasing awareness and education among healthcare providers [21] - Aurinia plans to file the Marketing Authorization Application (MAA) for Voclosporin in Europe by the end of the current quarter and is preparing to approach the PMDA in Japan [13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the early trends of LUPKYNIS launch despite challenges posed by the COVID-19 pandemic, anticipating a return to pre-COVID levels of patient care as vaccination rates increase [11] - The company expects to see increased prescribing momentum as more healthcare providers become aware of LUPKYNIS and as access improves [23] Other Important Information - The AURORA Phase 3 clinical study manuscript is expected to be published soon, and data will be presented at major medical events throughout 2021 [12] - The company has a strong balance sheet with over $360 million in cash to support ongoing activities into at least 2023 [14] Q&A Session Summary Question: Can you provide insights on titration and Medicaid formularies? - Management indicated that titration is on track and confirmed that 90% of Medicaid lives now have coverage as of April 1 [38][40] Question: Is the pace of enrollment forms and conversions accelerating? - Management noted that both patient start forms and the time from start forms to actual treatment have steadily increased, with no significant bolus of patients from previous trials [46] Question: What are the common adoption patterns observed? - Prescribers are split evenly between rheumatologists and nephrologists, with most prescribing occurring in community settings [53] Question: What percentage of lives do the 11 payers represent? - Management estimated that the 11 payers cover approximately 20% of the total lives [77] Question: Are patients starting LUPKYNIS while on MMF and steroids? - Management indicated that while some newly diagnosed patients are starting on LUPKYNIS, most patients have previously been treated without achieving their proteinuria goals [80]