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Apellis(APLS) - 2024 Q4 - Earnings Call Transcript

Financial Data and Key Metrics Changes - Total revenue for Q4 2024 was approximately 13million,withfullyearrevenuereaching13 million, with full-year revenue reaching 781 million, marking a nearly 100% increase compared to 2023 [48][50]. - The company reported a net loss of 36.4millionforQ42024[49].Cashandcashequivalentsattheendof2024stoodat36.4 million for Q4 2024 [49]. - Cash and cash equivalents at the end of 2024 stood at 411 million, indicating a strong financial position [51]. Business Line Data and Key Metrics Changes - Cipher generated over 120% year-over-year US net revenue growth, with nearly 900millioninsalesforXIFAVinlessthantwoyears[5][7].XIFAVmaintainedamarketshareofover60900 million in sales for XIFAV in less than two years [5][7]. - XIFAV maintained a market share of over 60%, with approximately 94,000 doses delivered in Q4 2024 [21]. - Empavelli generated approximately 23 million in U.S. net product revenue in Q4 2024, with compliance rates at 97% [35]. Market Data and Key Metrics Changes - The overall GA market growth in Q1 2025 was tempered due to typical seasonal dynamics, including Medicare reverifications and winter storms affecting distribution [22]. - The company estimates that less than 10% of patients with geographic atrophy are currently receiving treatment, indicating significant growth potential [8][91]. Company Strategy and Development Direction - The company focuses on three key pillars: transforming the treatment of geographic atrophy, maximizing the impact of Empavelli in rare diseases, and advancing its innovative pipeline [5][6]. - Plans include launching Empavelli in C3G and ICMPGN in the second half of 2025, with ongoing development of next-generation treatments for GA [14][42]. Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to create significant value for patients and shareholders, emphasizing a strong market position and growth potential in 2025 [53]. - The competitive landscape is viewed positively, with management noting that recent regulatory developments have reinforced their market leadership [19][92]. Other Important Information - The company plans to initiate a Phase 2 trial for a next-generation treatment for GA in Q2 2025 [40]. - Management highlighted the importance of patient access to retinal specialists and the need for higher utilization from physicians already treating patients with XIFAV [25]. Q&A Session Summary Question: Insights on Empavelli and FDA submission - Management expressed excitement about the submission for Empavelli and highlighted the importance of consistent results across various disease phenotypes [60][62]. Question: Expectations for Q1 results - Management indicated that Q1 results are expected to be lower than Q4 due to temporary factors but anticipates continued growth in 2025 [70][72]. Question: Competitive dynamics and label changes - Management discussed the impact of label changes for competitors and emphasized the unique advantages of XIFAV, including preferred status with payers [74][78]. Question: Market share and payer positioning - Management noted that they have secured preferred positioning with several major payers, which is expected to enhance market share [115][116]. Question: Patient adherence and sample usage - Management reported that adherence levels for XIFAV are positive and that increased sample usage is a sign of demand, which they believe is temporary [160][162].