Summary of Apellis Pharmaceuticals (APLS) 2025 Conference Call Company Overview - **Company**: Apellis Pharmaceuticals (APLS) - **Date**: September 04, 2025 - **Focus**: Launch of new drugs, particularly in the complement inhibition space with products Ciforvi and Empavelli Key Points Current State and Outlook - Apellis is positioned as a leader in the complement inhibition field with two products on the market: Ciforvi and Empavelli [3][5] - The company is experiencing stable growth with guidance of low to mid single-digit growth for Ciforvi over the next several quarters [3][4] Product Launch and Market Dynamics - The launch of Empavelli for C3G and ICMPGN is progressing as expected, with a focus on addressing unmet needs in these disease areas [6][9] - Approximately 5,000 patients have been identified with C3G and ICMPGN, highlighting the significant unmet need [7][8] - The company is optimistic about the gradual uptake of Empavelli, emphasizing the importance of patient education and the functional benefits of the drug [9][10] Clinical Trials and Pipeline - Ongoing Phase 2 trial combining subcutaneous injection with Ciforvi aims to extend the dosing interval from every two months to every three months [4] - Two Phase 3 clinical trials for FSGS and delayed graft function are set to begin enrollment in the latter part of the year [4][52] - The company is also exploring preclinical programs that will be discussed in the following year [4][63] Financial Position - Apellis has a stable financial situation, ending the quarter with $370 million in the bank, which is expected to support the path to profitability [5][57] - A recent royalty deal with Sobe has strengthened the balance sheet and provided a growth platform [5][58] Competitive Landscape - Ciforvi is currently the market leader in new injections and total market share, with a recent shift in new treatment share favoring Ciforvi at approximately 55% [30][31] - The company is focused on generating additional data to maintain its competitive edge and grow the overall market [33][34] Regulatory and Market Access - Apellis is confident in navigating the regulatory landscape for its products, particularly in the context of delayed graft function [56] - The company is working on reimbursement strategies and co-pay assistance to ensure patient access to treatments [17][48] Future Developments - The company is exploring innovative approaches, such as functional OCT measurements, to enhance understanding of treatment impacts and patient experiences [38][41] - Apellis is also engaged in gene editing programs that aim to reduce immunoglobulin levels without affecting albumin, indicating a focus on novel therapeutic avenues [63][64] Additional Insights - The company is optimistic about the potential for Empavelli in transplant patients, which could change treatment paradigms in this area [22][23] - There is a strong emphasis on educating healthcare providers about the serious implications of diseases treated by Apellis, which could enhance market penetration [20][34] This summary encapsulates the key discussions and insights from the Apellis Pharmaceuticals conference call, highlighting the company's strategic direction, product pipeline, and market positioning.

Financial 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 [10][11] - Operating expenses decreased to $212 million from $229 million in Q2 2024, with expectations for 2025 operating expenses to align with 2024 levels [14] - The company ended the quarter with $370 million in cash and cash equivalents, which, along with a $275 million cash payment from a royalty purchase agreement, is expected to fund the business to sustainable profitability [14][12] 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 and over 60% total market share in geographic atrophy (GA) [7][10] - Empavli revenue was $21 million, up 5% quarter-over-quarter, with patient compliance rates at 97% [11] - The company anticipates meaningful revenue generation from C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (ICMPGN) opportunities in 2025 [11] Market Data and Key Metrics Changes - The market opportunity in GA is significant, with Cyfovri's leadership and strong patent life indicating low likelihood of new entrants in the next few years [7] - The company estimates approximately 5,000 C3G and primary ICMPGN patients in the U.S., with expectations for Empavli to become the preferred treatment option [20] Company Strategy and Development Direction - The company is focused on expanding into rare nephrology with the launch of Empavli for C3G and ICMPGN, and plans to develop Empavli for delayed graft function (DGF) and focal segmental glomerulosclerosis (FSGS) [15][16] - The strategy includes raising awareness of Empavli as a disease-modifying therapy and establishing it as the treatment of choice among nephrologists [21][22] - The company aims to leverage its strong clinical data to support the approval and adoption of Empavli [21] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the long-term potential of Cyfovri, citing its market leadership and the significant unmet needs in the GA market [7][8] - The company is optimistic about the growth trajectory of Empavli, especially following its recent FDA approval for C3G and ICMPGN [20] - Management acknowledged the challenges posed by high levels of free goods usage due to funding shortages but remains focused on transitioning patients to commercial products [10][14] Other Important Information - The company announced key leadership appointments, including Dr. Leslie Meltzer as Chief Research and Development Officer and Kelly Boucher as Chief People Officer [28][29] - A capped royalty purchase agreement with Sobe was established, providing a $275 million upfront cash payment and potential future milestones [12][13] Q&A Session Summary Question: Concerns about GA market growth compared to competitors - Management highlighted their clear leadership in metrics such as revenue and market share, emphasizing the quality of their data and the larger database used for competitive analysis [34][35] Question: Inquiry about sampling trends - Management noted that growth in injections is expected to continue, with a slight bump in samples due to ongoing demand [39][42] Question: FSGS Phase III plans and endpoints - Management confirmed plans to enroll in pivotal trials for FSGS by the end of the year, aligning with recent work on endpoints [44][45] Question: Impact of funding dynamics on patient treatment - Management acknowledged that some patients are unable to start treatment due to funding gaps, but emphasized ongoing efforts to assist patients through various programs [103][104] Question: Expectations for future injection growth - Management indicated that they expect stable, steady, gradual growth in injections, with a long way to go in terms of market penetration [51][67] Question: Clarification on patient start forms and REMS enrollments - Management confirmed that initial reporting will be on total start forms, with more detailed breakdowns to follow as data becomes available [116][120]