Apellis(US:APLS)2025-07-31 13:32Financial Data and Key Metrics Changes - Total revenue for Q2 2025 was $178 million, with Cyfovri net product revenue of $151 million, reflecting a 6% quarter-over-quarter growth in total injections [11][9] - Operating expenses decreased to $212 million in Q2 2025 from $229 million in 2024, with expectations for 2025 operating expenses to align with 2024 levels [15] - The company ended the quarter with $370 million in cash and cash equivalents, which, combined with a $275 million cash payment from a royalty purchase agreement, is expected to fund the business to sustainable profitability [15][13] Business Line Data and Key Metrics Changes - Cyfovri revenues were $151 million, with a 6% growth in total injections, maintaining a 55% share of new patient starts in the geographic atrophy (GA) market [9][11] - Empavli revenue was $21 million, up 5% quarter-over-quarter, with patient compliance rates at 97% [12] - The launch of Empavli for C3 glomerulopathy and primary immune complex membranoproliferative glomerulonephritis is underway, with expectations for meaningful revenue generation from these opportunities in 2025 [12][20] Market Data and Key Metrics Changes - The market opportunity in GA is significant, with Cyfovri's market leadership and strong patent life indicating a low likelihood of new entrants in the coming years [9] - The company estimates approximately 5,000 patients in the U.S. for C3G and primary ICMPGN, with expectations for Empavli to become the preferred treatment option [20] - The company is focused on expanding awareness and access for Empavli, particularly among nephrologists and patient communities [21][22] Company Strategy and Development Direction - The company aims to maximize the potential of Empavli by raising awareness, establishing it as the treatment of choice, and securing broad access for patients [21][22] - The strategy includes expanding Empavli's development into other rare kidney diseases, such as delayed graft function and focal segmental glomerulosclerosis [16][17] - The company is also focused on maintaining Cyfovri's market leadership through education and engagement with the clinical community [24][26] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the long-term potential of Cyfovri and the growth opportunities for Empavli, particularly in underserved populations [10][12] - The company is optimistic about the impact of recent FDA approvals and the ongoing demand for its products, despite challenges related to funding shortages in patient assistance programs [11][20] - Management highlighted the importance of continued education and awareness efforts to drive patient treatment and compliance [22][104] Other Important Information - The company announced key leadership appointments, including a new Chief Research and Development Officer and Chief People Officer, to support its growth strategy [28][29] - The company is actively working to address the funding gap affecting patient access to treatments, with ongoing efforts to transition patients from assistance programs to commercial products [94][95] Q&A Session Summary Question: Can you help clarify the GA market dynamics given competitor growth claims? - Management emphasized their clear leadership across all metrics, including revenue and market share, and noted the quality of their data compared to competitors [33][35][36] Question: What are the trends in sampling and patient starts? - Management indicated that growth in injections is expected to continue, with a slight bump in sampling due to ongoing demand [39][41] Question: What are the plans for FSGS trial endpoints? - Management confirmed they are aligned with recent work on endpoints and are excited about the upcoming trial [43][45] Question: How is the company addressing the funding gap for patient assistance? - Management acknowledged the ongoing challenges but expressed commitment to supporting patients through various programs [84][85] Question: What metrics will be reported for Empavli's launch? - Management stated that initial reporting will focus on total start forms, with more detailed breakdowns to follow as data becomes available [116][120]