Aurinia Pharmaceuticals(AUPH) - 2019 Q4 - Earnings Call Transcript

Financial Data and Key Metrics Changes - As of December 31, 2019, Aurinia had cash and cash equivalents of $306 million, a significant increase from $125.9 million at the end of 2018, primarily due to net proceeds of $179.9 million from a public offering [19] - The consolidated net loss for the year ended December 31, 2019, was $123.8 million, or $1.33 per common share, compared to a net loss of $64.1 million, or $0.76 per common share in 2018 [20][21] - Research and development expenses increased to $52.9 million in 2019 from $41.4 million in 2018, reflecting higher costs related to various studies [23] Business Line Data and Key Metrics Changes - The company reported positive results from the AURORA Phase III trial for voclosporin, achieving a renal response rate of 40.8% compared to 22.5% for the control arm, with a p-value of less than 0.001 [11] - The AURORA study met all pre-specified hierarchical secondary endpoints, demonstrating robust efficacy across various subgroups [11] Market Data and Key Metrics Changes - The company is preparing for a rolling NDA submission to the FDA, with expectations for priority review and potential approval in early 2021 [16] - Aurinia is also evaluating voclosporin for primary FSGS and has ongoing studies for dry eye syndrome, with results expected in the second half of 2020 [17] Company Strategy and Development Direction - Aurinia's strategic focus remains on voclosporin and its clinical development programs, with plans for a commercial launch following FDA approval [26] - The company is building a world-class commercial team to support the launch and has hired experienced leaders from the industry [15] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the regulatory process, noting no significant roadblocks during the pre-NDA meeting with the FDA [31] - The company aims to diversify its pipeline and is actively seeking partnerships for global commercialization [46][48] Other Important Information - The company plans to present additional AURORA study results at various medical congresses throughout the year [12] - Aurinia's share price increased significantly in December 2019, impacting the estimated fair value of derivative warrant liabilities [22] Q&A Session Summary Question: Can you provide insights on the pre-NDA meeting and potential advisory committee involvement? - Management reported a positive interaction with the FDA, with no significant roadblocks identified, and anticipates an advisory committee meeting due to the new molecular entity status [31][32] Question: What strategies are in place to build brand loyalty and commercial infrastructure? - The company plans to implement a comprehensive commercial model that includes manufacturing, distribution, and customer support to enhance brand loyalty [34] Question: What are the plans for European regulatory interactions? - Aurinia intends to follow up with the EMA application process, which is approximately six months behind the U.S. regulatory timeline [39] Question: How does the company view the competitive landscape with other therapies? - Management believes voclosporin's rapid response time will provide a competitive advantage over other therapies that may take longer to show results [76] Question: What are the goals for the commercial team as it builds out? - The focus is on establishing a robust infrastructure for a successful launch, including hiring additional personnel and developing marketing strategies [53][54]