Aurinia Pharmaceuticals(US:AUPH)2020-05-15 02:58Financial Data and Key Metrics Changes - As of March 31, 2020, Aurinia had cash, cash equivalents, and short-term investments of $286.1 million, down from $306 million as of December 31, 2019 [27] - The company reported a consolidated net loss of $16.5 million or $0.15 per common share for Q1 2020, compared to a net loss of $12.4 million or $0.14 per common share for Q1 2019 [28] - Net cash used in operating activities was $22.7 million for Q1 2020, compared to $13.1 million for Q1 2019 [27] Business Line Data and Key Metrics Changes - R&D expenses increased to $13.8 million for Q1 2020, up from $10.6 million in Q1 2019, primarily due to NDA submission preparation and related activities [29] - Corporate, administration, and business development expenses rose to $11.1 million for Q1 2020, compared to $3.9 million for Q1 2019, reflecting the expansion of the commercial team and higher consulting fees [31] Market Data and Key Metrics Changes - The company is preparing to explore voclosporin in other proteinuric kidney diseases, including pediatric nephrotic syndrome and adult idiopathic membranous glomerular nephropathy, indicating a shift in market focus [19] - The lupus nephritis market is estimated to have around 200,000 to 250,000 patients in the U.S. [52] Company Strategy and Development Direction - Aurinia aims to submit the NDA for voclosporin by the end of Q2 2020, with a potential launch shortly after FDA approval [12] - The company is focusing on building a world-class commercial team to support the launch of voclosporin, leveraging expertise in nephrology and rheumatology [25] - The strategic shift includes moving resources from FSGS studies to larger, more commercially viable indications [19] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the NDA submission process, noting positive interactions with the FDA [36][37] - The company is preparing for multiple launch scenarios in light of COVID-19, including normal, full lockdown, and limited access scenarios [38] Other Important Information - The company has established a U.S. commercial hub in Rockville, Maryland, to facilitate the launch of voclosporin [15] - A new Chief Financial Officer, Joe Miller, has joined the company, succeeding Dennis Bourgeault [14] Q&A Session Summary Question: Feedback from the FDA and launch strategies during COVID - Management reported positive feedback from the FDA and is preparing for various launch scenarios, including virtual engagement with physicians [36][38] Question: Intellectual property and dosing instructions - The company hopes to include specific dosing instructions in the drug label, based on successful trial protocols [42] Question: Anticipated indication structure and patient coverage - The target label is focused on treating lupus nephritis, with an estimated patient population of 200,000 to 250,000 in the U.S. [52] Question: Real-world dosing adjustments for physicians - The dosing scheme is designed to be accessible and not add complexity to current treatment practices [54][56] Question: Market research on off-label use - The company is conducting market research to understand potential off-label uses and indications for voclosporin [77]