Apellis(APLS)2025-05-07 13:30Financial Data and Key Metrics Changes - Apellis Pharmaceuticals reported a net product revenue of 358 million in cash and cash equivalents, indicating confidence in funding operations to profitability [12] Business Line Data and Key Metrics Changes - Cifovri injection demand grew by 4% quarter over quarter, but revenue fell short of expectations due to inventory drawdown and funding issues [5][10] - Empaveli generated $20 million in net product revenue for Q1 2025, with high compliance rates of 97% [19] Market Data and Key Metrics Changes - Cifovri maintains over 60% market share in geographic atrophy, with new patient starts exceeding 50% in Q1 and reaching 55% by late April [6][14] - The U.S. commercial opportunity for Empaveli in C3G and iCMPGN is estimated at 5,000 patients, with expectations for broad usage across patient groups [18] Company Strategy and Development Direction - The company is focused on expanding its market leadership in geographic atrophy and preparing for the launch of Empaveli in C3G and iCMPGN [4][7] - Apellis aims to drive revenue growth while maintaining financial discipline and delivering meaningful treatments to patients [20] Management's Comments on Operating Environment and Future Outlook - Management acknowledged challenges in Q1 but expressed confidence in the growth potential of Cifovri and the upcoming launch of Empaveli [4][20] - The company is preparing for pivotal studies in focal segmental glomerulosclerosis and delayed graft function in the second half of 2025 [8] Other Important Information - Apellis announced the addition of Craig Wheeler to its Board of Directors, bringing extensive biopharmaceutical leadership experience [21] - The company is actively working on educational programs to help practices manage patient reimbursement amid co-pay assistance funding shortages [15][16] Q&A Session Summary Question: Clarification on Q1 volume dynamics - Management clarified that Q1 saw a 4% growth in injections, with the reduction in vials delivered due to inventory drawdown and increased sample usage [27][30] Question: New patient share calculation - The company uses a site of care data set covering about 50% of the market for accurate new patient share calculations, differing from competitors' claims data [41] Question: Impact of co-pay assistance program - Management does not expect the co-pay assistance underfunding issue to resolve soon, and they are working to transition patients from samples to commercial doses [32][34] Question: Launch plans for C3G and ICMPGN - The company is actively profiling accounts and engaging with KOLs to ensure a strong launch for Empaveli upon approval [108][109] Question: Tariff exposure and manufacturing - The company is analyzing potential tariff exposure but has not disclosed specific details about manufacturing locations or IP domicile [74] Question: Net price dynamics in Q1 - Management noted that revenue recognition occurs when doses are shipped to distributors, which may not directly correlate with vials shipped to physicians [80][82]