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Mar 31, 2021
Aurinia Q1 2021 Earnings Report
Reported first quarter 2021 financial results with FDA approval, launch, and early market penetration of LUPKYNIS.
Key Takeaways
Aurinia Pharmaceuticals reported a net loss of $50.4 million for the quarter ended March 31, 2021. Revenues were $0.9 million, primarily from commercial sales of LUPKYNIS, which began in January 2021. Cash and cash equivalents and investments totaled $360.9 million as of March 31, 2021.
FDA approved, launched, and achieved early market penetration of LUPKYNIS as the first approved oral therapy for lupus nephritis (LN).
Received over 250 patient start forms by the end of the first quarter.
Cash and cash equivalents, and investments totaled $360.9 million at March 31, 2021.
LUPKYNIS trajectory is on track against internal projections.
Aurinia
Aurinia
Aurinia Revenue by Segment
Revenue by Segment
Product Revenue
CapyFin.comLicense & Royalty Revenue
CapyFin.com Forward Guidance
Aurinia anticipates several milestones, including filing a marketing authorization application (MAA) with the European Medicines Agency (EMA) during the first half of 2021, initiating a study of voclosporin in adolescent patients (VOCAL study) during the second half of 2021, and reporting top-line results from the ongoing AURORA-2 continuation study during the first quarter of 2022.
Positive Outlook
- Filing a marketing authorization application (MAA) with the European Medicines Agency (EMA) during the first half of 2021 with partner, Otsuka.
- Abstracts discussing voclosporin accepted for presentation at the Annual European Congress of Rheumatology (EULAR 2021 Congress), June 2 – 5, 2021, and at the Nephrology Virtual Congress (ERA-EDTA 2021), June 5 – 8, 2021.
- Initiating a study of voclosporin in adolescent patients (VOCAL study) during the second half of 2021.
- Reporting top-line results from the ongoing AURORA-2 continuation study during the first quarter of 2022.
- Market access will continue to improve as the rate of COVID vaccinations in the United States continues to climb and healthcare centers re-open their doors to patients
Challenges Ahead
- Difficulties Aurinia may experience in completing the commercialization of voclosporin.
- The market for the LN business may not be as estimated.
- Aurinia may have to pay unanticipated expenses.
- Aurinia may not be able to obtain sufficient supply to meet commercial demand for voclosporin in a timely fashion.
- Unknown impact and difficulties imposed by the COVID-19 pandemic on Aurinia’s business operations including nonclinical, clinical, regulatory and commercial activities.
Revenue & Expenses
Visualization of income flow from segment revenue to net income