Pegcetacoplan

Full-year 2025 net product revenues of $689 million SYFOVRE ® (pegcetacoplan injection) full year 2025 net product revenue of $587 million EMPAVELI ® (pegcetacoplan) full year 2025 net product revenue of $102 million Regulatory submission for SYFOVRE prefilled syringe planned for the first half of 2026 EMPAVELI franchise has strong momentum with successful launch in C3G and primary IC-MPGN, and pivotal trials underway in FSGS and DGF Cash and cash equivalents of $466 million as of December 31, 2025; projected revenues, cash, and cash equivalents expected to be sufficient to fund operations to profitability Management to host conference call today at 8:30 a.m. ET WALTHAM, Mass., Feb. 24, 2026 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals , Inc. (Nasdaq: APLS), today announced its fourth quarter and full year 2025 financial results and business highlights. “2025 was a year of disciplined execution and meaningful progress across the business, and we enter 2026 with clear priorities and a strong foundation,” said Cedric Francois, M.D., Ph.D., chief executive officer at Apellis. “We are focused on positioning SYFOVRE for its next phase of growth, maximizing EMPAVELI’s blockbuster opportunity in rare kidney diseases, and advancing a differentiated, self-funded pipeline leveraging our deep expertise in C3 biology.” Fourth Quarter and Full Year 2025 Business Highlights and Upcoming Milestones Transforming the treatment of geographic atrophy (GA) with SYFOVRE Reported $155 million and $587 million in U.S. net product revenues in the fourth quarter and full year 2025, respectively. Total injections increased 17% year-over-year, reflecting continued strong underlying demand. Continued market leadership in GA with total market share of approximately 60%. Delivered approximately 102K SYFOVRE doses to physician offices during the fourth quarter of 2025, including approximately 89K commercial doses and approximately 13K free goods doses. Advanced best-in-class prefilled syringe, with a regulatory submission planned in the first half of 2026. Presented new data on the OCT-F (Optical Coherence Tomography – Functional) program, an AI imaging tool designed to visualize functional decline and quantify treatment impact, at the virtual Angiogenesis (Angiogenesis, Exudation, and Degeneration) annual meeting in February 2026; the tool is expected to be available for research use in retina specialist practices in the second half of 2026. Eight abstracts were accepted for oral presentation at the upcoming Macula Society Annual Meeting, including the first presentation of comprehensive five-year results from the GALE open-label extension study. The Phase 2 study of SYFOVRE + APL-3007, a potential next generation treatment aimed at comprehensively blocking complement activity in the retina and choroid, is ongoing with topline data expected in 2027. Maximizing EMPAVELI’s impact in rare diseases Recorded $35 million and $102 million in U.S. net product revenues in the fourth quarter and full year 2025, respectively. Executed strong early launch in C3 glomerulopathy (C3G) and primary immune complex glomerulonephritis (IC-MPGN). Received 267 cumulative patient start forms as of December 31, 2025, representing more than 5% penetration of the U.S. patient population 1 following the first full quarter post-launch. Achieved favorable payer access with 95% of published policies covering to label or with minimal restrictions. Sobi recently received European Commission approval for Aspaveli in C3G and primary IC-MPGN, triggering a $25 million milestone payment to Apellis based on the July 2025 royalty purchase agreement. Initiated pivotal trials for focal segmental glomerulosclerosis (FSGS) and delayed graft function (DGF), two rare kidney diseases with significant complement pathway involvement and high unmet need. Advancing innovative pipeline, leveraging complement expertise Progressed investigational pre-clinical research of APL-9099 2 , a potential one-time neonatal Fc receptor (FcRn) treatment using base editing technology from Beam Therapeutics. An investigational new drug (IND) submission is planned for the second half of 2026. Fourth Quarter and Full Year 2025 Financial Results Total revenue for the three and twelve months ended December 31, 2025, was $199.9 million and $1.0 billion, respectively, compared to $212.5 million and $781.4 million for the same periods in 2024, and mainly consists of: Product net sales for SYFOVRE and EMPAVELI: SYFOVRE U.S. net product revenue for the three and twelve months ended December 31, 2025, was $155.2 million and $586.9 million, respectively, compared to $167.8 million and $611.8 million for the same periods in 2024. EMPAVELI U.S. net product revenue for the three and twelve months ended December 31, 2025, was $35.1 million and $102.4 million, respectively, compared to $23.4 million and $98.1 million for the same periods in 2024. Licensing and other revenue for the three and twelve months ended December 31, 2025, was $9.6 million and $314.4 million, respectively, compared to $21.4 million and $71.4 million for the same periods in 2024. This mainly relates to the Company’s licensing and other revenue associated with the Sobi collaboration, including the one-time $275.0 million upfront payment from the Sobi royalty repurchase agreement, which was recorded in the third quarter of 2025. Total operating expenses for the three and twelve months ended December 31, 2025, were $251.1 million and $948.4 million, respectively, compared to $238.7 million and $946.3 million for the same periods in 2024, and mainly consists of: Cost of sales for the three and twelve months ended December 31, 2025, were $29.7 million and $102.2 million, respectively, compared to $40.9 million and $117.7 million for the same periods in 2024. Cost of sales consists primarily of costs associated with the manufacturing of SYFOVRE and EMPAVELI, royalties owed to our licensor for such sales, costs associated with Sobi revenue, and certain period costs. R&D expenses for the three and twelve months ended December 31, 2025, were $74.2 million and $295.9 million, respectively, compared to $76.4 million and $327.6 million for the same periods in 2024. The decrease in R&D expenses for the full year ended December 31, 2025, was primarily attributable to a decrease in program specific external costs and compensation and related personnel costs. Selling, General and Administrative (SG&A) expenses for the three and twelve months ended December 31, 2025, were $147.1 million and $550.3 million, respectively, compared to $121.5 million and $501.1 million for the same periods in 2024. The increase was primarily attributable to an increase in professional and consulting fees, an increase in personnel related cost and an increase in general and administrative expenses, including contributions to patient assistance organizations, office expenses, travel expenses, insurance expenses, professional and consulting fees, and other general and administrative expenses, which was partially offset by a decrease in general commercial activities. Net Loss / Income: For the three months ended December 31, 2025, the Company reported a net loss of $58.9 million, compared to a net loss of $36.4 million for the same period in 2024. For the twelve months ended December 31, 2025, the Company reported net income of $22.4 million, compared to a net loss of $197.9 million for the full year 2024. Cash and cash equivalents of $466.2 million as of December 31, 2025, compared to $411.3 million in cash and cash equivalents as of December 31, 2024. Apellis continues to expect that its cash and cash equivalents, combined with expected product revenues, will fund the business to profitability. Conference Call and Webcast Apellis will host a conference call and webcast to discuss its fourth quarter and full year 2025 financial results and business highlights today, February 24, 2026, at 8:30 a.m. ET. To access the live call by phone, please pre-register for the call here . A live audio webcast of the event and accompanying slides may also be accessed through 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 30 days following the event. About SYFOVRE ® (pegcetacoplan injection) SYFOVRE ® (pegcetacoplan injection) is the first-ever approved therapy for geographic atrophy (GA). By targeting C3, SYFOVRE is designed to provide comprehensive control of the complement cascade, part of the body’s immune system. SYFOVRE is approved in the United States for the treatment of GA secondary to age-related macular degeneration. About EMPAVELI ® /Aspaveli ® (pegcetacoplan) EMPAVELI ® /Aspaveli ® (pegcetacoplan) is a targeted C3 therapy designed to regulate excessive activation of the complement cascade, part of the body’s immune system, which can lead to the onset and progression of many serious diseases. It is the first treatment approved in the United States for C3 glomerulopathy (C3G) or primary immune complex membranoproliferative glomerulonephritis (IC-MPGN) in patients 12 years of age or older, to reduce proteinuria. EMPAVELI/Aspaveli ® is also approved for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH) in the United States, European Union, and other countries globally, and for the treatment of C3G and primary IC-MPGN in the European Union and other countries globally. EMPAVELI is being evaluated for the treatment of additional rare diseases. About the Apellis and Sobi Collaboration Apellis and Sobi have global co-development rights for systemic pegcetacoplan. Sobi has exclusive ex-U.S. commercialization rights for systemic pegcetacoplan, and Apellis has exclusive U.S. commercialization rights for systemic pegcetacoplan and worldwide commercial rights for ophthalmological pegcetacoplan, including for geographic atrophy. U.S. Important Safety Information for SYFOVRE ® (pegcetacoplan injection) CONTRAINDICATIONS SYFOVRE is contraindicated in patients with ocular or periocular infections, in patients with active intraocular inflammation, and in patients with hypersensitivity to pegcetacoplan or any of the excipients in SYFOVRE. Systemic hypersensitivity reactions (e.g., anaphylaxis, rash, urticaria) have occurred. WARNINGS AND PRECAUTIONS Endophthalmitis and Retinal Detachments Intravitreal injections, including those with SYFOVRE, may be associated with endophthalmitis and retinal detachments. Proper aseptic injection technique must always be used when administering SYFOVRE to minimize the risk of endophthalmitis. Patients should be instructed to report any symptoms suggestive of endophthalmitis or retinal detachment without delay and should be managed appropriately. Retinal Vasculitis and/or Retinal Vascular Occlusion Retinal vasculitis and/or retinal vascular occlusion, typically in the presence of intraocular inflammation, have been reported with the use of SYFOVRE. Cases may occur with the first dose of SYFOVRE and may result in severe vision loss. Discontinue treatment with SYFOVRE in patients who develop these events. Patients should be instructed to report any change in vision without delay. Neovascular AMD In clinical trials, use of SYFOVRE was associated with increased rates of neovascular (wet) AMD or choroidal neovascularization (12% when administered monthly, 7% when administered every other month and 3% in the control group) by Month 24. Patients receiving SYFOVRE should be monitored for signs of neovascular AMD. In case anti-Vascular Endothelial Growth Factor (anti-VEGF) is required, it should be given separately from SYFOVRE administration. Intraocular Inflammation In clinical trials, use of SYFOVRE was associated with episodes of intraocular inflammation including: vitritis, vitreal cells, iridocyclitis, uveitis, anterior chamber cells, iritis, and anterior chamber flare. After inflammation resolves, patients may resume treatment with SYFOVRE. Increased Intraocular Pressure Acute increase in IOP may occur within minutes of any intravitreal injection, including with SYFOVRE. Perfusion of the optic nerve head should be monitored following the injection and managed as needed. ADVERSE REACTIONS Most common adverse reactions (incidence ≥5%) are ocular discomfort, neovascular age-related macular degeneration, vitreous floaters, conjunctival hemorrhage. Please see full Prescribing Information for more information. for more information. U.S. Important Safety Information for EMPAVELI ® (pegcetacoplan) BOXED WARNING: SERIOUS INFECTIONS CAUSED BY ENCAPSULATED BACTERIA EMPAVELI, a complement inhibitor, increases the risk of serious infections, especially those caused by encapsulated bacteria, such as Streptococcus pneumoniae, Neisseria meningitidis , and Haemophilus influenzae type B. Life-threatening and fatal infections with encapsulated bacteria have occurred in patients treated with complement inhibitors. These infections may become rapidly life-threatening or fatal if not recognized and treated early. Complete or update vaccination for encapsulated bacteria at least 2 weeks prior to the first dose of EMPAVELI, unless the risks of delaying therapy with EMPAVELI outweigh the risks of developing a serious infection. Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for vaccinations against encapsulated bacteria in patients receiving a complement inhibitor. Patients receiving EMPAVELI are at increased risk for invasive disease caused by encapsulated bacteria, even if they develop antibodies following vaccination. Monitor patients for early signs and symptoms of serious infections and evaluate immediately if infection is suspected. Because of the risk of serious infections caused by encapsulated bacteria, EMPAVELI is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the EMPAVELI REMS. CONTRAINDICATIONS Hypersensitivity to pegcetacoplan or to any of the excipients For initiation in patients with unresolved serious infection caused by encapsulated bacteria including Streptococcus pneumoniae , Neisseria meningitidis , and Haemophilus influenzae type B WARNINGS AND PRECAUTIONS Serious Infections Caused by Encapsulated Bacteria EMPAVELI, a complement inhibitor, increases a patient’s susceptibility to serious, life-threatening, or fatal infections caused by encapsulated bacteria including Streptococcus pneumoniae , Neisseria meningitidis (caused by any serogroup, including non-groupable strains), and Haemophilus influenzae type B. Life-threatening and fatal infections with encapsulated bacteria have occurred in both vaccinated and unvaccinated patients treated with complement inhibitors. The initiation of EMPAVELI treatment is contraindicated in patients with unresolved serious infection caused by encapsulated bacteria. Complete or update vaccination against encapsulated bacteria at least 2 weeks prior to administration of the first dose of EMPAVELI, according to the most current ACIP recommendations for patients receiving a complement inhibitor. Revaccinate patients in accordance with ACIP recommendations considering the duration of therapy with EMPAVELI. Note that ACIP recommends an administration schedule in patients receiving complement inhibitors that differs from the administration schedule in the vaccine prescribing information. If urgent EMPAVELI therapy is indicated in a patient who is not up to date with vaccines against encapsulated bacteria according to ACIP recommendations, provide the patient with antibacterial drug prophylaxis and administer these vaccines as soon as possible. The benefits and risks of treatment with EMPAVELI, as well as the benefits and risks of antibacterial drug prophylaxis in unvaccinated or vaccinated patients, must be considered against the known risks for serious infections caused by encapsulated bacteria. Vaccination does not eliminate the risk of serious encapsulated bacterial infections, despite development of antibodies following vaccination. Closely monitor patients for early signs and symptoms of serious infection and evaluate patients immediately if an infection is suspected. Inform patients of these signs and symptoms and instruct patients to seek immediate medical care if these signs and symptoms occur. Promptly treat known infections. Serious infection may become rapidly life-threatening or fatal if not recognized and treated early. Consider interruption of EMPAVELI in patients who are undergoing treatment for serious infections. EMPAVELI is available only through a restricted program under a REMS. EMPAVELI REMS EMPAVELI is available only through a restricted program under a REMS called EMPAVELI REMS, because of the risk of serious infections caused by encapsulated bacteria. Notable requirements of the EMPAVELI REMS include the following: Under the EMPAVELI REMS, prescribers must enroll in the program. Prescribers must counsel patients about the risks, signs, and symptoms of serious infections caused by encapsulated bacteria, provide patients with the REMS educational materials, ensure patients are vaccinated against encapsulated bacteria at least 2 weeks prior to the first dose of EMPAVELI, prescribe antibacterial drug prophylaxis if patients’ vaccine status is not up to date and treatment must be started urgently, and provide instructions to always carry the Patient Safety Card both during treatment, as well as for 2 months following last dose of EMPAVELI. Pharmacies that dispense EMPAVELI must be certified in the EMPAVELI REMS and must verify prescribers are certified. Further information is available at or 1-888-343-7073. Infusion-Related Reactions Systemic hypersensitivity reactions (eg, facial swelling, rash, urticaria, pyrexia) have occurred in patients treated with EMPAVELI, which may resolve after treatment with antihistamines. Cases of anaphylaxis leading to treatment discontinuation have been reported. If a severe hypersensitivity reaction (including anaphylaxis) occurs, discontinue EMPAVELI infusion immediately, institute appropriate treatment, per standard of care, and monitor until signs and symptoms are resolved. Monitoring Paroxysmal Nocturnal Hemoglobinuria (PNH) Manifestations after Discontinuation of EMPAVELI After discontinuing treatment with EMPAVELI, closely monitor for signs and symptoms of hemolysis, identified by elevated LDH levels along with sudden decrease in PNH clone size or hemoglobin, or reappearance of symptoms such as fatigue, hemoglobinuria, abdominal pain, dyspnea, major adverse vascular events (including thrombosis), dysphagia, or erectile dysfunction. Monitor any patient who discontinues EMPAVELI for at least 8 weeks to detect hemolysis and other reactions. If hemolysis, including elevated LDH, occurs after discontinuation of EMPAVELI, consider restarting treatment with EMPAVELI. Interference with Laboratory Tests There may be interference between silica reagents in coagulation panels and EMPAVELI that results in artificially prolonged activated partial thromboplastin time (aPTT); therefore, avoid the use of silica reagents in coagulation panels. ADVERSE REACTIONS Most common adverse reactions in adult patients with PNH (incidence ≥10%) were injection site reactions, infections, diarrhea, abdominal pain, respiratory tract infection, pain in extremity, hypokalemia, fatigue, viral infection, cough, arthralgia, dizziness, headache, and rash. Most common adverse reactions in adult and pediatric patients 12 years of age and older with C3 glomerulopathy (C3G) or primary immune-complex membranoproliferative glomerulonephritis (IC-MPGN) (incidence ≥10%) were injection-site reactions, pyrexia, nasopharyngitis, influenza, cough, and nausea. USE IN SPECIFIC POPULATIONS Females of Reproductive Potential EMPAVELI may cause embryo-fetal harm when administered to pregnant women. Pregnancy testing is recommended for females of reproductive potential prior to treatment with EMPAVELI. Advise female patients of reproductive potential to use effective contraception during treatment with EMPAVELI and for 40 days after the last dose. Please see full Prescribing Information , including Boxed WARNING regarding serious infections caused by encapsulated bacteria, and Medication Guide . About Apellis Apellis Pharmaceuticals, Inc. is a global biopharmaceutical company leading the way in complement science to develop life-changing therapies for some of the most challenging diseases patients face. We ushered in the first new class of complement medicine in 15 years and now have two C3-targeting medicines approved to treat four serious diseases. Breakthroughs for patients include the first-ever therapy for geographic atrophy, a leading cause of blindness, and the first treatment for patients 12 and older with C3G or primary IC-MPGN, two severe, rare kidney diseases. We believe we have only begun to unlock the potential of targeting C3 across many serious diseases. For more information, please visit or follow us on LinkedIn and X . Apellis Forward-Looking Statement Statements in this press release 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,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including whether the results of the Company’s clinical trials for EMPAVELI, SYFOVRE, or any of its future products will warrant regulatory submissions to the FDA or equivalent foreign regulatory agencies and whether the Company will make regulatory submissions when anticipated; the rate and degree of market acceptance and clinical utility of EMPAVELI, SYFOVRE and any future products for which we receive marketing approval will impact our commercialization efforts; whether data from the Company’s clinical trials will be available when anticipated; whether results obtained in clinical trials will be indicative of results that will be generated in future clinical trials or in the real world setting; whether the Company’s products will generate the revenues projected by the Company, the Company will achieve profitability or maintain profitability, if achieved; whether the Company cash resources, together with its projected revenues, will fund its operations through profitability; and other factors discussed in the “Risk Factors” section of Apellis’ Annual Report on Form 10-K with the Securities and Exchange Commission on February 24, 2026 and in other filings that Apellis may make with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Apellis specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. Media Contact: Tracy Vineis me dia@ apellis.com 617.420.4839 Investor Contact: Eva Stroynowski ir@apellis.com 617.938.6229 APELLIS PHARMACEUTICALS, INC. CONSOLIDATED BALANCE SHEETS (Amounts in thousands, except per share amounts) December 31, December 31, 2025 2024 Assets Current assets: Cash and cash equivalents $ 466,233 $ 411,290 Accounts receivable 366,221 264,926 Inventory 142,556 81,404 Prepaid and other current assets 38,303 30,012 Restricted cash 1,527 1,322 Total current assets 1,014,840 788,954 Non-current assets: Right-of-use assets 18,195 16,083 Property and equipment, net 1,708 2,952 Long-term inventory 34,959 75,713 Other assets 5,555 1,349 Total assets $ 1,075,257 $ 885,051 Liabilities and Stockholders' Equity Current liabilities: Accounts payable 56,798 38,572 Accrued expenses 166,049 140,184 Convertible senior notes 93,662 — Current portion of lease liabilities 7,087 6,753 Total current liabilities 323,596 185,509 Long-term liabilities: Long-term credit facility 361,664 359,489 Convertible senior notes — 93,341 Lease liabilities 11,947 10,201 Other liabilities 7,903 7,972 Total liabilities 705,110 656,512 Stockholders' equity: Preferred stock, $0.0001 par value; 10,000 shares authorized and zero shares issued and outstanding at December 31, 2025 and 2024 — — Common stock, $0.0001 par value; 200,000 shares authorized at December 31, 2025 and 2024; 126,621 and 124,495 shares issued and outstanding at December 31, 2025 and 2024, respectively 12 12 Additional paid-in capital 3,385,216 3,267,201 Accumulated other comprehensive loss (2,103 ) (3,308 ) Accumulated deficit (3,012,978 ) (3,035,366 ) Total stockholders' equity 370,147 228,539 Total liabilities and stockholders' equity $ 1,075,257 $ 885,051 APELLIS PHARMACEUTICALS, INC. CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE (LOSS)/INCOME (Amounts in thousands, except per share amounts) For the Three Months Ended December 31, For the Year Ended December 31, 2025 2024 2025 2024 Revenue: Product revenue, net $ 190,341 $ 191,172 $ 689,383 $ 709,954 Licensing and other revenue 9,572 21,356 314,399 71,413 Total revenue: 199,913 212,528 1,003,782 781,367 Operating expenses: Cost of sales 29,719 40,856 102,236 117,723 Research and development 74,233 76,354 295,854 327,570 Selling, general and administrative 147,103 121,482 550,265 501,053 Operating expenses: 251,055 238,692 948,355 946,346 Net operating (loss)/income (51,142 ) (26,164 ) 55,427 (164,979 ) Loss on extinguishment of development liability — — — (1,949 ) Interest income 3,502 3,396 13,143 12,773 Interest expense (10,847 ) (11,534 ) (44,327 ) (40,391 ) Other expense, net (151 ) (1,765 ) (133 ) (2,170 ) Net (loss)/income before taxes (58,638 ) (36,067 ) 24,110 (196,716 ) Income tax expense 313 286 1,722 1,162 Net (loss)/income $ (58,951 ) $ (36,353 ) $ 22,388 $ (197,878 ) Other comprehensive (loss)/income: Unrealized (loss)/gain on pension plans (30 ) 591 107 591 Foreign currency translation 327 (759 ) 1,098 (357 ) Total other comprehensive income/(loss) 297 (168 ) 1,205 234 Comprehensive (loss)/income, net of tax $ (58,654 ) $ (36,521 ) $ 23,593 $ (197,644 ) Net (loss)/income per share Basic earnings per share $ 0.47 $ (0.29 ) $ 0.18 $ (1.60 ) Diluted earnings per share $ 0.47 $ (0.29 ) $ 0.20 $ (1.60 ) Weighted-average shares used in calculating: Basic earnings per share 126,661 124,523 126,145 123,905 Diluted earnings per share 126,661 124,523 129,855 123,905 1 Based on Apellis estimate of approximately 5,000 U.S. patient population for C3G and primary IC-MPGN. 2 Lipid nanoparticle (LNP) technology licensed from Acuitas Therapeutics, Inc.