Aurinia Pharmaceuticals(US:AUPH)2021-05-05 16:00Revenue and Sales - Total revenue for the three months ended March 31, 2021, was $914 thousand, a significant increase from $30 thousand for the same period in 2020, representing an increase of 2,946%[130] - Product revenue, net for the three months ended March 31, 2021, was $884 thousand, primarily due to the commercial sales of LUPKYNIS following FDA approval[131] Expenses - Selling, general and administrative expenses increased to $39.3 million for the three months ended March 31, 2021, compared to $11.1 million for the same period in 2020, reflecting an increase of 254%[135] - Research and development expenses decreased to $9.8 million for the three months ended March 31, 2021, down from $13.8 million in the same period in 2020, a reduction of 29%[136] Profitability and Loss - Gross margin for the three months ended March 31, 2021, was approximately 95%[132] - The net loss for the three months ended March 31, 2021, was $50.4 million, compared to a net loss of $25.9 million for the same period in 2020, an increase of 95%[130] Regulatory and Development Milestones - The FDA approved LUPKYNIS on January 22, 2021, for the treatment of adult patients with active LN, marking a significant milestone for the company[125] - The company plans to file a marketing authorization application (MAA) with the European Medicines Agency (EMA) for LUPKYNIS in the first half of 2021[121] - The company is required to conduct two pediatric studies and other studies as a condition of FDA approval, with reports due between 2023 and 2031[120] Financial Position - The company believes it has sufficient financial resources to fund its current plans for at least the next 12 months[119] - As of March 31, 2021, the company had cash and cash equivalents of $156.6 million and short-term investments of $191.7 million, a decrease from $272.4 million and $126.0 million respectively at December 31, 2020[139] - Working capital as of March 31, 2021 was $351.1 million, down from $387.4 million at December 31, 2020[139] Cash Flow - Cash used in operating activities for the three months ended March 31, 2021 was $53.5 million, an increase of $30.9 million from $22.6 million for the same period in 2020[142] - Cash used in investing activities for the three months ended March 31, 2021 was $67.2 million, compared to $12.1 million for the same period in 2020[143] - Cash provided by financing activities for the three months ended March 31, 2021 was $5.0 million, an increase from $2.9 million in the same period in 2020[143] - The company believes its cash position is sufficient to fund current plans for at least the next 12 months, including commercialization of LUPKYNIS and R&D programs[140] Risk Factors - A 10% increase in the U.S. dollar would have increased the net loss by $0.3 million, assuming all other variables remained constant[149] - The company has no off-balance sheet arrangements as defined under Regulation S-K[144] - The investment portfolio includes cash and cash equivalents and investments that earn interest at market rates, primarily consisting of bonds and commercial paper with a maturity of less than two years[148] - The company has internal policies to monitor customer credit limits to mitigate credit risk[150]