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Aurinia Pharmaceuticals(AUPH) - 2023 Q3 - Earnings Call Transcript

Financial Data and Key Metrics Changes - Aurinia achieved $40.8 million in LUPKYNIS net product revenue for Q3 2023, a 60% increase compared to Q3 2022 [6] - Year-to-date LUPKYNIS net product revenue reached $116.2 million, representing a 55% increase year-over-year [6] - Total revenue for Q3 2023 was $154.5 million, including a $10 million milestone from Otsuka Pharmaceuticals [7] - The company narrowed its 2023 net product revenue guidance from $150 million to $160 million to a new range of $155 million to $160 million [6] Business Line Data and Key Metrics Changes - Patient start forms (PSFs) totaled 436 in Q3 2023, a 17% increase from the prior year's third quarter [7] - Approximately 90% of patients with a submitted PSF received actual treatment, with 65% starting therapy within 20 days [8] - The 12-month persistency rate for patients on therapy is around 54%, with 15-month persistency at about 48% and 18-month persistency at 43% [8] Market Data and Key Metrics Changes - The company reported approximately 4,000 patients treated with LUPKYNIS since its launch [8] - Aurinia's strategy focuses on educating healthcare providers and patients to increase screening and treatment for lupus nephritis [9][10] Company Strategy and Development Direction - Aurinia aims to activate three main levers for growth: educating healthcare providers, activating patient advocacy, and clinically differentiating LUPKYNIS [9] - The company is leveraging data from the AURORA trial and the AURORA II extension study to promote LUPKYNIS [9][16] - Aurinia is actively working with Otsuka to expand LUPKYNIS's market presence outside the U.S., having secured approvals in several European countries [18] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the strong results and momentum in the first three quarters of 2023 [33] - The company is focused on delivering LUPKYNIS to patients and driving results in key global markets [33] - Management is committed to a strategic review process to explore options for enhancing shareholder value [21] Other Important Information - As of September 30, 2023, Aurinia had cash and investments totaling $338.5 million, down from $389.4 million at the end of 2022 [22] - The company recorded a net loss of $13.4 million for Q3 2023, compared to a net loss of $9 million in Q3 2022 [31] Q&A Session Summary Question: Feedback from prescribers on patient persistency - Management noted encouraging feedback regarding persistency rates and emphasized the importance of maintaining therapy to control the inflammatory process [37] Question: Trends in diagnosis rates - Management indicated that qualitative data suggests an increase in diagnosis rates, but quantitative data is not yet available [39] Question: Higher cost of goods sold (COGS) - Management explained that the increase in COGS was due to full absorption of the model plant facility, which is partially reimbursed by Otsuka [41] Question: New guidance rationale - Management tightened the revenue guidance range conservatively based on new patient starts and historical performance [44] Question: Trends in prescribers - Management reported double-digit increases in both volume of prescribing and the number of prescribers [46] Question: Expectations for 2024 - Management plans to provide guidance for 2024 around the time of the JPMorgan conference, maintaining consistency with previous years [49] Question: Impact of EULAR guidelines - Management expressed hope that upcoming KDIGO and ACR guidelines will align with EULAR guidelines, promoting aggressive use of novel therapies [63] Question: Discontinuation rates - Management clarified that higher discontinuation rates were due to a mix of patients who had been on therapy longer, not seasonal factors [66] Question: Changes in prescriber trends - Management noted improvements in the percentage of repeat prescribers, indicating a positive trend in prescribing behavior [69]