Core Insights - Apellis Pharmaceuticals (APLS) received FDA approval for EMPAVELI targeting C3 glomerulopathy and IC-MPGN, with the stock trading around $28 at the time of approval [1] Company Summary - The FDA approval of EMPAVELI marks a significant milestone for Apellis Pharmaceuticals, potentially impacting its market position and stock performance [1]

Core Insights - Apellis Pharmaceuticals' stock has decreased by 31% over the past year despite receiving FDA approval for EMPAVELI, indicating a disconnect between regulatory success and commercial performance [2][7] Product Approval and Market Potential - EMPAVELI is the first and only approved treatment for C3 glomerulopathy and IC-MPGN, targeting approximately 5,000 patients in the U.S., with exclusive approval for about two-thirds of this population [3] - The positive opinion from the European CHMP in December 2025 enhances the global expansion potential and pricing power, typically associated with gross margins exceeding 90% [3] Patient Start Forms and Growth Expectations - Management has guided for 225 cumulative patient start forms by the end of 2025, having achieved 152 by the end of September, suggesting a slowdown to 24 forms per month in Q4 [4] - CEO Cedric Francois indicated that the company is moving past the initial wave of early adopters and anticipates steady growth moving into the next year [4] Revenue Challenges and Market Dynamics - SYFOVRE, which constitutes the majority of revenue, reported flat sales of $151 million in Q3 2025, with a mere 4% growth in injections, primarily driven by free goods costing the company $15 million [5] - The share of new patients for SYFOVRE has decreased to 52%, with management noting that retina specialists are adopting a cautious approach despite SYFOVRE's 60% market share [5] External Market Issues - The cessation of new co-pay assistance applications by Good Days Foundation has led to practices halting new patient enrollments, a challenge not unique to Apellis but reflective of broader issues in the geographic atrophy market [6]

Core Insights - Apellis is focused on the complement pathways, particularly complement factor C3, which allows exploration of various therapeutic options across multiple areas [1] - The company is currently self-funded and has identified growth drivers for both the near and long term [2] Company Overview - Apellis has established a foundation around its products SYFOVRE and EMPAVELI, which are expected to support its future pipeline [2] - SYFOVRE is generating a steady and durable revenue stream that aligns with the company's long-term growth ambitions [2]

2 Transforming innovation into durable value creation Apellis: The Leading Complement Company 44th Annual J.P. Morgan Healthcare Conference Cedric Francois, M.D., Ph.D. Co-Founder, Chief Executive Officer and President January 12, 2026 ARCHER Living with C3G Forward-looking statements Statements in this presentation about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute "forward-looking statements" within the meaning of ...

Financial Data and Key Metrics Changes - The company is currently cash neutral and on a path to profitability, with over $450 million in cash available [6][64] - The company reported a dramatic reduction in proteinuria of approximately 68% in patients with C3 glomerulopathy and immune complex membranoproliferative glomerulonephritis [10][11] - The company has been skating close to cash operational expenses, indicating strong financial health [64] Business Line Data and Key Metrics Changes - Apellis has two approved drugs: EMPAVELI for paroxysmal nocturnal hemoglobinuria (PNH) and recently approved indications for C3 glomerulopathy and immune complex membranoproliferative glomerulonephritis [5][6] - SYFOVRE, the first treatment for geographic atrophy, was approved in 2023 and has stabilized its market share at just north of 60% [6][45] Market Data and Key Metrics Changes - The prevalence of C3G and IC-MPGN in the U.S. is approximately 5,000 patients, with about 50% progressing to end-stage renal disease over ten years [9] - The company has achieved around 5% market penetration with 225 start forms for the new indications within five months [14][32] Company Strategy and Development Direction - The company is focused on educating nephrologists about its new drug indications and differentiating its products from competitors [16][19] - Future trials are planned for FSGS and delayed graft function, with expectations of positive outcomes based on the underlying disease mechanisms [26][28] Management's Comments on Operating Environment and Future Outlook - Management noted that the competitive landscape for PNH has not led to significant patient loss, with 15% of patients returning to EMPAVELI after trying oral alternatives [24] - The company anticipates a strong 2026, with ongoing efforts to improve physician education and patient access to treatments [64][77] Other Important Information - The company is developing a siRNA combination therapy that aims to enhance the efficacy of SYFOVRE and potentially allow for less frequent dosing [67][69] - There is a focus on leveraging machine learning and AI to improve patient imaging and tracking disease progression [58][61] Q&A Session Summary Question: What is the opportunity with C3G and IC-MPGN? - The company highlighted the significant unmet need in these kidney diseases and the potential for its drug to provide a new treatment option [9][10] Question: How will the company increase its market share in the 5,000 prevalent pool? - Management emphasized the importance of education and building relationships with nephrologists to drive adoption [16][19] Question: What is the current status of SYFOVRE in the market? - The company reported stabilization in market share and ongoing efforts to communicate the drug's benefits to the retina community [40][45] Question: What are the timelines for upcoming studies? - The company indicated that trials for FSGS and delayed graft function have just opened, with updates expected next year [28][29] Question: How is the company addressing the impact of patient copay assistance foundations? - Management acknowledged the significant impact on patient access and is focusing on physician education to mitigate these challenges [75][76]

Core Insights - Apellis is in a strong position with a foundational technology targeting the complement cascade, specifically C3, which is believed to optimally control complement dysregulation [2] - The company has achieved three drug approvals in approximately 3 to 3.5 years, indicating a robust pipeline and growth potential [2] Drug Approvals - The first approval was for EMPAVELI, targeting paroxysmal nocturnal hemoglobinuria [3] - The second approval was for SYFOVRE, which addresses geographic atrophy, received about 2.5 years ago [3] - Recently, EMPAVELI received a second approval for C3G and IC-MPGN, bringing the total indications to four [3]

Core Insights - Apellis Pharmaceuticals, Inc. reported a revenue of $458.58 million for the quarter ended September 2025, marking a year-over-year increase of 133% [1] - The earnings per share (EPS) for the same period was $1.67, a significant improvement from -$0.46 a year ago [1] - The reported revenue exceeded the Zacks Consensus Estimate of $366.21 million by 25.22%, while the EPS surprise was 62.14% above the consensus estimate of $1.03 [1] Revenue Breakdown - Product revenue, net was $177.76 million, slightly below the nine-analyst average estimate of $178.43 million, reflecting a year-over-year change of 0.7% [4] - Licensing and other revenue reached $280.82 million, significantly surpassing the estimated $126.67 million, representing a year-over-year increase of 1286.2% [4] - Product Revenue from EMPAVELI was $26.83 million, exceeding the average estimate of $22.06 million, with a year-over-year change of 9% [4] - Product Revenue from SYFOVRE was $150.93 million, slightly below the average estimate of $156.55 million, showing a year-over-year decrease of 0.7% [4] Stock Performance - Shares of Apellis Pharmaceuticals have returned +30.1% over the past month, outperforming the Zacks S&P 500 composite's +3.6% change [3] - The stock currently holds a Zacks Rank 3 (Hold), indicating potential performance in line with the broader market in the near term [3]

Financial Data and Key Metrics Changes - Total revenue for Q3 2025 was $459 million, including a $275 million upfront payment from Sobi related to the EMPAVELI royalty purchase agreement [21] - SYFOVRE net product revenue for the quarter was $151 million, with approximately 101,000 doses delivered, including 86,000 commercial doses and 15,000 free goods doses [21] - Operating expenses were $235 million in Q3 2025, down from $244 million in the same quarter last year [24] Business Line Data and Key Metrics Changes - EMPAVELI generated total net product revenue of $27 million during Q3 2025, with a focus on C3 glomerulopathy and primary immune complex membranoproliferative glomerulonephritis [24] - SYFOVRE maintained a leading position, accounting for an estimated 52% of new patient starts during Q3 2025, with a total injection growth of 4% [15][16] Market Data and Key Metrics Changes - The addressable market for EMPAVELI expanded by approximately 5,000 patients following FDA approval for C3 glomerulopathy and primary ICMPGN [6] - Only about 10% of patients diagnosed with geographic atrophy (GA) are currently treated with complement inhibitors, indicating significant room for growth [16] Company Strategy and Development Direction - The company aims to leverage its expertise in complement-mediated diseases to expand market opportunities for EMPAVELI and SYFOVRE while advancing its pipeline [8][9] - Initiatives to drive growth include targeted market education and the development of artificial intelligence tools to enhance physician understanding of GA [18] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the long-term growth potential of EMPAVELI and SYFOVRE, highlighting positive early feedback from the nephrology community regarding EMPAVELI [26] - The company anticipates steady, measured injection growth for SYFOVRE, with expectations for renewed growth driven by new tools and education initiatives [8][16] Other Important Information - The company ended the quarter with $475 million in cash and cash equivalents, supported by the Sobi transaction [24] - The company plans to initiate pivotal trials for FSGS and DGF by the end of the year, expanding EMPAVELI's development into other rare kidney diseases [20] Q&A Session Summary Question: Regarding the launch of EMPAVELI and C3G - Management expects steady, consistent growth going into next year after the initial wave of early adopters [31] Question: On SYFOVRE sampling and market dynamics - Management is closely monitoring sampling and free goods programs to ensure they are utilized effectively [37] Question: Specifics on C3G patient demographics - Approximately 50 of the 152 start forms are from the Expanded Access Program, with positive feedback on efficacy leading to switches from competitive products [41] Question: Timeline for patient access to EMPAVELI - The typical timeframe for patients to start treatment is four to six weeks, with efforts underway to accelerate this process [52] Question: On the impact of co-pay assistance on patient treatment - The lack of co-pay support has created logistical and financial headwinds, affecting treatment discussions with patients [95] Question: Insights on physician behavior regarding biopsies for C3G - The availability of effective treatments like EMPAVELI motivates clinicians to diagnose and treat patients more aggressively [123]

Third Quarter 2025 Financial Results Conference Call October 30, 2025 Forward-looking statements Statements in this presentation about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute "forward-looking statements" within the meaning of The Private Securities Litigation Reform Act of 1995. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "projec ...

Group 1 - The article discusses Apellis Pharmaceuticals and its potential market position in the treatment of rare kidney diseases [2] - The author runs a pharmaceutical analysis service that provides in-depth research on various biotech companies, including a model portfolio of small and mid-cap stocks [2] - The service offers a subscription model with a promotional free trial and discounted yearly plan [1] Group 2 - The article emphasizes the importance of data from Apellis regarding rare kidney diseases, suggesting it may lead to a first-to-market advantage [2]