Apellis(US:APLS)2023-11-01 18:36Financial Data and Key Metrics Changes - Total revenue for Q3 2023 was $110 million, consisting of $24 million from EMPAVELI U.S. net product revenue, $75 million from SYFOVRE U.S. net product revenue, and $11 million in collaboration revenue from Sobi [24][25] - R&D expenses were $79 million, G&A expenses were $146 million, resulting in a net loss of $140 million [25] - Cash and cash equivalents as of September 30, 2023, were $452 million, with an expected cash runway extending into at least the second quarter of 2025 [26] Business Line Data and Key Metrics Changes - SYFOVRE generated $75 million in U.S. net product revenue in Q3 2023, up approximately 12% quarter-over-quarter, totaling over $160 million in the first seven months since launch [6][13] - EMPAVELI generated $24 million in U.S. net product revenue for Q3 2023, with a year-to-date total of $67 million [9][16] Market Data and Key Metrics Changes - Over 100,000 vials of SYFOVRE have been distributed since launch, indicating strong demand and positive impact on patients [6][13] - The estimated rate of retinal vasculitis with SYFOVRE remains rare at 0.01%, with a significantly lower rate of irreversible vision loss [7][31] Company Strategy and Development Direction - The company is focused on maximizing SYFOVRE's global leadership in geographic atrophy (GA) and streamlining the EMPAVELI business, with a restructuring expected to yield cost savings of up to $300 million through 2024 [11][12] - Plans to launch SYFOVRE in Europe are underway, with a submission for reimbursement in the UK and expectations for a decision in the first half of 2024 [15][66] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth trajectory of SYFOVRE and EMPAVELI, highlighting a rebound in demand and positive feedback from the medical community [27][28] - The company anticipates continued growth in the PNH market with EMPAVELI and is optimistic about the upcoming European Medicines Agency decision for SYFOVRE [8][66] Other Important Information - The company has received FDA approval for the EMPAVELI Injector, enhancing patient experience and simplifying administration [9] - Management noted that the ongoing efficiencies from restructuring will not be reflected in operating expenses until 2024 [26] Q&A Session Summary Question: Update on vials shipped and doses given - Management indicated that approximately 37,000 commercial vials were shipped in Q3, with an estimated 1 to 1.5 weeks of demand vials sitting in refrigerators [28][30] Question: Competitive landscape and feedback from the field - Management noted that feedback from physicians has been relatively quiet regarding competition, and they remain focused on executing their plan for SYFOVRE [33][36] Question: Utilization breakdown of SYFOVRE - Management reported continued enthusiasm from physicians, with double-digit new accounts starting SYFOVRE every week since launch [40][42] Question: Rate of vasculitis and updates - Management confirmed that the rate of vasculitis remains stable and low, with no individual case updates planned unless there are significant changes [53][55] Question: European market opportunity and physician feedback - Management expressed confidence in the European approval process and noted that KOLs in Europe are well-informed and supportive of SYFOVRE [62][66]