Aurinia Pharmaceuticals(US:AUPH)2022-05-10 16:34Financial Data and Key Metrics Changes - The company generated $21.6 million in net sales for Q1 2022, a significant increase from $914,000 in Q1 2021, attributed to the launch of LUPKYNIS [21][10] - The total cash, cash equivalents, and restricted cash decreased to $418.8 million from $466.1 million at the end of 2021, primarily due to investments in commercialization and pipeline advancement [20][21] - The net loss for Q1 2022 was $37.6 million, or $0.27 per share, compared to a net loss of $50.4 million, or $0.40 per share, in Q1 2021 [25] Business Line Data and Key Metrics Changes - The company added 461 new patient start forms in Q1 2022, compared to 257 in Q1 2021, with a total of 647 patient start forms as of May 6, 2022 [11][12] - Patient access to LUPKYNIS is confirmed through payers representing about 90% of total U.S. lives, with a conversion rate of 80% after 90 days [12][10] - Approximately 70% of patients remained on treatment after six months, indicating strong persistence trends [12] Market Data and Key Metrics Changes - The company reported a monthly record high for patient start forms in March 2022, indicating a recovery in prescribing rates following a slowdown due to COVID-19 [11][10] - Awareness of LUPKYNIS among healthcare providers has increased, with unaided brand awareness over 70% and over 90% for aided awareness [13] Company Strategy and Development Direction - The company aims to gain regulatory approval for LUPKYNIS in Europe, with potential milestone payments of up to $30 million in the second half of 2022 [16] - The company is focused on expanding its commercial execution and has launched new healthcare provider marketing programs [15] - The R&D pipeline includes ongoing studies for AUR200 and AUR300, with IND submissions planned for 2023 [18] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the increasing prescribing rates and the comfort of healthcare providers in treating lupus nephritis patients with LUPKYNIS [26] - The company remains confident in its guidance for net LUPKYNIS sales of $115 million to $135 million for the full year of 2022 [15] - Management acknowledged the impact of COVID-19 on patient access and refill rates but noted a return to normalcy in healthcare interactions [14][10] Other Important Information - The company has a healthy balance sheet with no significant debt, allowing it to weather current market conditions [18] - The company is committed to patient education and support programs to improve adherence to therapy [62] Q&A Session Summary Question: Update on ongoing litigation with Sun Pharmaceuticals - The company confirmed that the litigation is ongoing, with no new updates expected until 2023 [29] Question: Factors driving the drag on Q1 performance - Management indicated that the decline was due to refill rates impacted by COVID-19 and seasonal insurance changes [32][34] Question: Insights on patient discontinuations - Discontinuations are primarily due to tolerability issues, and patients may return to therapy after seeing their doctors [42][46] Question: Pricing metrics and assumptions - The average net revenue per patient is expected to approach $65,000 per year, with adherence rates around 80% [48][49] Question: Details on the pediatric study and post-approval commitments - The company is conducting a pediatric study and has ongoing commitments related to AURORA 2 and drug interaction studies [66]