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]

Financial Performance - Preliminary U.S. net product revenues for full-year 2025 were approximately $689 million, with Q4 revenues of about $155 million[5][13]. - Cash and cash equivalents as of December 31, 2025, were approximately $466 million, expected to fund operations to profitability[10]. Product Demand and Market Penetration - SYFOVRE total injection demand grew 17% year-over-year, maintaining a market share of approximately 60% in geographic atrophy[5][6]. - EMPAVELI achieved more than 5% market penetration in C3G and primary IC-MPGN, with 267 new patient start forms in 2025[3][12]. Regulatory and Clinical Developments - Regulatory submission for a prefilled syringe of SYFOVRE is planned in the first half of 2026[5][6]. - Pivotal trials for EMPAVELI have been initiated in two additional nephrology indications: FSGS and DGF[5][12]. - APL-90993, a potential one-time treatment using base editing technology, is advancing with an IND submission planned in the second half of 2026[8]. - The Phase 2 study of SYFOVRE + APL-3007 is ongoing, with topline data expected in 2027[12]. - Sobi received a positive opinion from the EMA for Aspaveli's indication extension in C3G and primary IC-MPGN[12]. - The New England Journal of Medicine published positive Phase 3 VALIANT results for EMPAVELI in C3G and primary IC-MPGN[12]. Product Innovations - Apellis Pharmaceuticals has developed two C3-targeting medicines approved for treating four serious diseases, marking the first new class of complement medicine in 15 years[38]. - The company has introduced the first-ever therapy for geographic atrophy, a leading cause of blindness, and the first treatment for patients aged 12 and older with C3 glomerulopathy or primary immune-complex membranoproliferative glomerulonephritis[38]. Safety and Monitoring - EMPAVELI treatment requires monitoring for signs of hemolysis after discontinuation, with a recommended observation period of at least 8 weeks[33]. - Common adverse reactions for adult patients with PNH include injection site reactions, infections, and fatigue, with an incidence of ≥10%[35]. - For patients aged 12 and older with C3G or primary IC-MPGN, common adverse reactions include injection-site reactions and pyrexia, also with an incidence of ≥10%[36]. - The company emphasizes the importance of pregnancy testing for females of reproductive potential before starting EMPAVELI, advising effective contraception during treatment and for 40 days post-treatment[37]. Forward-Looking Statements and Company Focus - Apellis warns that actual results may differ from forward-looking statements due to various factors, including adjustments to revenue figures and regulatory approvals[39]. - The company is focused on unlocking the potential of targeting C3 across various serious diseases, indicating a commitment to ongoing research and development[38]. - Apellis has established media and investor contact channels for further inquiries, enhancing transparency and communication with stakeholders[40].

Summary of Apellis Pharmaceuticals FY Conference Call Company Overview - **Company**: Apellis Pharmaceuticals (NasdaqGS:APLS) - **Focus**: Complement pathways, specifically complement factor C3, with therapeutic options across various areas [2][3] Key Products and Market Position Syfovre - **Market Leadership**: Holds approximately 60% market share in geographic atrophy [4] - **Revenue Growth**: Achieved 17% year-over-year growth in total injections [4] - **Future Growth Drivers**: Anticipates renewed growth in 2027 with the introduction of a prefilled syringe, enhancing ease of administration [3][8] - **Patient Segmentation**: Targets advanced geographic atrophy, wet macular degeneration, and early geographic atrophy patients [5][6] - **Clinical Evidence**: Largest dataset in geographic atrophy shows the ability to slow disease progression by 1.5 years over five years [8][9] Empaveli - **Indications**: Approved for C3 glomerulopathy and immune complex membranoproliferative glomerulonephritis (IC-MPGN) [4][14] - **Market Penetration**: Achieved over 5% penetration in the first full quarter post-launch, with expectations of reaching approximately half of the 5,000 patient population [16] - **Launch Success**: Described as one of the best launches in rare disease nephrology, with strong payer reception [17][14] - **Clinical Trials**: Ongoing phase III trials for focal segmental glomerulosclerosis (FSGS) and delayed graft function, potentially expanding access to an additional 30,000 patients [14][19] Pipeline Developments - **APL-3007 Program**: A subcutaneous injection aimed at reducing systemic C3 levels by approximately 90%, potentially allowing for less frequent injections [13] - **Gene-Editing Approach**: APL-9099 program targeting the $20 billion FCRN market with a focus on reducing IgG levels while maintaining albumin levels [20][21] Market Dynamics and Competitive Landscape - **Competitive Advantage**: The prefilled syringe for Syfovre is expected to improve treatment flow in retina practices, enhancing competitive positioning against Izervae [8][28] - **Market Stability**: Syfovre's market share has remained stable, with a slight decrease in new patient share (50%-55%) compared to overall market share [41][42] - **Urgency in Nephrology**: Emphasized the need for improved patient identification and education among nephrologists to drive treatment urgency for Empaveli [17][38] Challenges and Considerations - **Regulatory Hurdles**: Syfovre has not yet received EMA approval, with ongoing efforts to address concerns regarding measuring functional benefits [31][33] - **Patient Access Issues**: Previous disruptions in treatment flow due to financial barriers have been addressed, leading to improved patient care dynamics [25][27] Conclusion - **Outlook**: Apellis Pharmaceuticals is positioned for growth with a strong pipeline and market leadership in geographic atrophy and nephrology, while navigating regulatory challenges and enhancing patient access strategies [22][42]

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 ...

Core Insights - Apellis Pharmaceuticals reported preliminary U.S. net product revenues of approximately $689 million for the full year 2025, with a strong focus on expanding its product offerings and market presence in 2026 [6][9][10]. Financial Performance - The company achieved approximately $155 million in U.S. net product revenues for the fourth quarter of 2025 and $587 million for the full year [17]. - Preliminary year-end cash and cash equivalents stood at approximately $466 million, which is expected to be sufficient to fund operations to profitability [10]. Product Development and Market Position - SYFOVRE (pegcetacoplan injection) demonstrated a 17% year-over-year growth in total injection demand, maintaining a market share of approximately 60% in the geographic atrophy (GA) market [6][7]. - EMPAVELI (pegcetacoplan) has achieved over 5% market penetration in C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN) following its first full quarter post-launch, with 267 new patient start forms received [6][7]. - The company plans to submit a regulatory application for a prefilled syringe of SYFOVRE in the first half of 2026 [6][7]. Strategic Initiatives - Apellis aims to expand its geographic atrophy market and strengthen SYFOVRE's competitive position through targeted initiatives [2]. - The company is advancing its pipeline, including pivotal trials for EMPAVELI in additional nephrology indications such as focal segmental glomerulosclerosis (FSGS) and delayed graft function (DGF) [6][7]. Collaborations and Partnerships - Apellis has a collaboration with Sobi for the global co-development of systemic pegcetacoplan, with Sobi holding exclusive ex-U.S. commercialization rights [14].

WALTHAM, Mass., Jan. 05, 2026 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) today announced that the company will present at the 44th Annual J.P. Morgan Healthcare Conference on Monday, January 12, 2026, at 11:15 a.m. PT. The live conference webcast will be posted on the “Events and Presentations” page of the “Investors and Media” section of the company’s website. A replay of the webcast will be available for approximately 90 days following the event. About ApellisApellis Pharmaceuticals, ...

Group 1 - The article discusses the importance of staying updated on stocks in the biotech, pharma, and healthcare sectors, highlighting key trends and catalysts that influence market valuations [1] - Apellis Pharmaceuticals, Inc. has received "Hold" ratings in recent analyses, indicating a cautious approach towards the stock [1] - The investing group Haggerston BioHealth, led by a biotech consultant with over five years of experience, offers insights and forecasts for over 1,000 companies in the biotech and pharma industries [1] Group 2 - The group provides detailed product sales forecasts, integrated financial statements, discounted cash flow analysis, and market-by-market analysis for major pharmaceutical companies [1]

Core Insights - Apellis Pharmaceuticals announced positive results from the Phase 3 VALIANT study for EMPAVELI (pegcetacoplan) in treating C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN), rare kidney diseases [1][4] Company Overview - Apellis Pharmaceuticals is a biopharmaceutical company focused on complement science, developing therapies for serious diseases, including the first treatment for C3G and primary IC-MPGN in patients aged 12 and older [25] Study Results - The VALIANT study demonstrated a statistically significant 68% reduction in proteinuria in EMPAVELI-treated patients compared to placebo [7] - EMPAVELI-treated patients showed stabilization of kidney function with a difference of +6.3 mL/min/1.73 m compared to placebo [7] - A majority of EMPAVELI-treated patients achieved zero C3 staining intensity, indicating complete clearance of C3 deposits [7][6] Safety Profile - The VALIANT study reported favorable safety and tolerability for EMPAVELI, with common adverse reactions including infusion site reactions, pyrexia, and nasopharyngitis [3][22] - No cases of meningococcal infection due to encapsulated bacteria were reported across over 2,750 patient-years of experience with EMPAVELI [3] Market Potential - Approximately 50% of patients with C3G and primary IC-MPGN may experience kidney failure within five to ten years of diagnosis, highlighting the urgent need for effective treatments [8] - The diseases are estimated to affect around 5,000 individuals in the U.S. and up to 8,000 in Europe, indicating a significant market opportunity for EMPAVELI [8]

Question-and-Answer SessionCedric FrancoisCo-Founder, President, CEO & Director Yes. Thank you, John, and thank you for inviting us again. This is a wonderful conference. So the launch is going exactly the way the commercial team had told us it would go. And that is really gratifying to see because it was a feat as many people on the buy and sell side will appreciate to understand the epidemiology of this disease, right? Patients with C3G and IC-MPGN, it's a rare disease, of course, are highly spread out ac ...

Summary of Apellis Pharmaceuticals FY Conference Call Company Overview - **Company**: Apellis Pharmaceuticals (NasdaqGS:APLS) - **Focus**: Development and commercialization of therapies for rare diseases, specifically targeting C3G and IC-MPGN with their product Empaveli, and geographic atrophy with Syfovre Key Points on Empaveli Launch - **Launch Progress**: The launch of Empaveli is proceeding as expected, with the commercial team effectively identifying the epidemiology of C3G and IC-MPGN, which are rare diseases [3][5] - **Patient Estimates**: The estimated patient population for C3G is around 5,000, aligning with internal expectations, contrasting with competitors' larger estimates [5] - **New Patient Starts**: In Q3, there were 152 new patient starts, with expectations of reaching 225 by year-end [6] - **Patient Identification**: The identification of new patients is facilitated through various sources, including patient organizations and claims data, leading to a robust pipeline of potential patients [7] - **Treatment Urgency**: There is a higher urgency for treatment in pediatric and post-transplant settings, where Apellis is the only approved product [8][10] - **Nephrologist Engagement**: Pediatric nephrologists are highly engaged and informed about Empaveli, with a good uptake in the transplantation segment [11][12] - **Long-term Adoption**: The adoption of Empaveli is expected to grow as nephrologists gain experience with the drug, with positive feedback from those who have used it [13][15] Key Points on Syfovre and Geographic Atrophy - **Market Perception**: The market for Syfovre has faced challenges, particularly due to funding issues affecting patient access to treatments for wet AMD, which indirectly impacted geographic atrophy patient enrollment [20][22] - **Patient Segments**: There are three key patient segments for Syfovre: advanced geographic atrophy, early geographic atrophy, and patients with wet macular degeneration [24] - **Long-term Data**: The GALE trial data indicates that treatment can save patients 1.5 years of vision over five years, which is significant for patient outcomes [25] - **Prefilled Syringes**: The introduction of prefilled syringes is anticipated to improve the adoption of Syfovre by streamlining the administration process [28][29] - **Market Position**: Apellis maintains a competitive position in the market, with prescription rates stabilizing around mid-50% for Syfovre compared to competitors in the low 45% range [33] Additional Insights - **Seasonality and Cadence**: There is no expected significant seasonality affecting new patient starts for Empaveli, but the conversion from start forms to paying customers may take time [19] - **Future Outlook**: The company aims to help physicians reimagine the treatment landscape for geographic atrophy, focusing on long-term data and patient outcomes [26][27] - **Combination Studies**: Apellis is exploring combination therapies, such as the Abelast 3007, which aims to enhance treatment efficacy and dosing frequency [34] This summary encapsulates the key insights from the Apellis Pharmaceuticals FY Conference Call, highlighting the company's strategic focus, market dynamics, and future growth opportunities.