Apellis(US:APLS)2025-10-30 13:30Financial Data and Key Metrics Changes - Total revenue for Q3 2025 was $459 million, including a $275 million upfront payment from Sobi related to the EMPAVELI royalty purchase agreement [21] - SYFOVRE net product revenue for the quarter was $151 million, with approximately 101,000 doses delivered, including 86,000 commercial doses and 15,000 free goods doses [21] - Operating expenses were $235 million in Q3 2025, down from $244 million in the same quarter last year [24] Business Line Data and Key Metrics Changes - EMPAVELI generated total net product revenue of $27 million during Q3 2025, with a focus on C3 glomerulopathy and primary immune complex membranoproliferative glomerulonephritis [24] - SYFOVRE maintained a leading position, accounting for an estimated 52% of new patient starts during Q3 2025, with a total injection growth of 4% [15][16] Market Data and Key Metrics Changes - The addressable market for EMPAVELI expanded by approximately 5,000 patients following FDA approval for C3 glomerulopathy and primary ICMPGN [6] - Only about 10% of patients diagnosed with geographic atrophy (GA) are currently treated with complement inhibitors, indicating significant room for growth [16] Company Strategy and Development Direction - The company aims to leverage its expertise in complement-mediated diseases to expand market opportunities for EMPAVELI and SYFOVRE while advancing its pipeline [8][9] - Initiatives to drive growth include targeted market education and the development of artificial intelligence tools to enhance physician understanding of GA [18] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the long-term growth potential of EMPAVELI and SYFOVRE, highlighting positive early feedback from the nephrology community regarding EMPAVELI [26] - The company anticipates steady, measured injection growth for SYFOVRE, with expectations for renewed growth driven by new tools and education initiatives [8][16] Other Important Information - The company ended the quarter with $475 million in cash and cash equivalents, supported by the Sobi transaction [24] - The company plans to initiate pivotal trials for FSGS and DGF by the end of the year, expanding EMPAVELI's development into other rare kidney diseases [20] Q&A Session Summary Question: Regarding the launch of EMPAVELI and C3G - Management expects steady, consistent growth going into next year after the initial wave of early adopters [31] Question: On SYFOVRE sampling and market dynamics - Management is closely monitoring sampling and free goods programs to ensure they are utilized effectively [37] Question: Specifics on C3G patient demographics - Approximately 50 of the 152 start forms are from the Expanded Access Program, with positive feedback on efficacy leading to switches from competitive products [41] Question: Timeline for patient access to EMPAVELI - The typical timeframe for patients to start treatment is four to six weeks, with efforts underway to accelerate this process [52] Question: On the impact of co-pay assistance on patient treatment - The lack of co-pay support has created logistical and financial headwinds, affecting treatment discussions with patients [95] Question: Insights on physician behavior regarding biopsies for C3G - The availability of effective treatments like EMPAVELI motivates clinicians to diagnose and treat patients more aggressively [123]