Apellis Pharmaceuticals Reports First Quarter 2025 Financial Results

Generated $166.8 million in 1Q 2025 revenues, including $149.9 million in U.S. net product salesSYFOVRE® (pegcetacoplan injection) injection demand grew 4% quarter-over-quarter, with U.S. net product revenue of $130.2 million Increase in demand offset by inventory dynamics and funding shortages at co-pay assistance programs Received U.S. FDA filing acceptance of supplemental new drug application (sNDA) with Priority Review designation for EMPAVELI for treatment of C3G and primary IC-MPGNOn track to initiate two pivotal trials of EMPAVELI in focal segmental glomerulosclerosis (FSGS) and in delayed graft function (DGF) in 2H 2025Cash and cash equivalents of $358.4 million as of March 31, 2025; projected revenues and cash expected to be sufficient to fund operations to profitability Management to host conference call today at 8:30 a.m. ET WALTHAM, Mass., May 07, 2025 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS), today announced its first quarter 2025 financial results and business highlights. “In the first quarter, we were pleased to see continued growth in SYFOVRE injection demand—a key indicator of long-term market strength—and an increase in share of new patient starts, already reaching 55% in April. However, revenue was impacted by funding shortages at third-party co-pay assistance programs and a larger-than-expected drawdown of total channel inventory, including physician offices,” said Cedric Francois, M.D., Ph.D., chief executive officer at Apellis. “We also made meaningful progress toward a potential FDA approval of EMPAVELI in C3G and IC-MPGN, with a decision in these new indications expected in July. As we grow our commercial business and advance our innovative pipeline, Apellis is on a clear path to becoming a profitable, well-established biotechnology company.” First Quarter 2025 Business Highlights and Upcoming Milestones Transforming the treatment of geographic atrophy (GA) SYFOVRE: Generated $130.2 million in SYFOVRE U.S. net product revenue in the first quarter of 2025. Revenue impacted by inventory and funding shortage at co-pay assistance programsQoQ total injection growth of 4%Delivered approximately 92,000 SYFOVRE doses to physician offices, including ~82,000 commercial doses and ~10,000 samples.Market leader in GA with more than 60% share of the overall marketShare of new patient starts continuing to increase and reaching 55% by late April On track to initiate Phase 2 study of APL-3007 + SYFOVRE in 2Q 2025; potential next generation treatment aimed at comprehensively blocking complement activity in the retina and choroid. Maximizing EMPAVELI’s impact in rare diseases Paroxysmal nocturnal hemoglobinuria (PNH): Recorded $19.7 million in EMPAVELI U.S. net product revenue for the first quarter 2025.Continued high patient compliance rates of 97%. C3 glomerulopathy (C3G) and primary immune complex glomerulonephritis (IC-MPGN): PDUFA target action date is July 28, 2025. FDA has stated that it is not currently planning to hold an advisory committee to discuss the application. Sobi received validation from the European Medicines Agency for its indication extension application for Aspaveli® (pegcetacoplan). Focal segmental glomerulosclerosis (FSGS) and delayed graft function (DGF) On track to initiate pivotal studies in 2H 2025, one in FSGS and one in DGF, two rare kidney diseases in which the complement pathway plays a significant role and there are no approved therapies. Advancing innovative pipeline, leveraging complement expertise Advancing investigational pre-clinical research for one-time neonatal Fc receptor (FcRn) treatment using gene editing technology from Beam Therapeutics. Organizational Updates Craig Wheeler was recently appointed to the Board of Directors. Mr. Wheeler is the chief executive officer of Headwaters Biotech Advisors and a highly accomplished executive with more than 30 years of leadership experience across the biopharmaceutical industry. Previously, Mr. Wheeler served as president and chief executive officer of Momenta Pharmaceuticals. During his 14-year tenure, he led the company from its early stages through multiple product launches and ultimately its acquisition by Johnson and Johnson in 2020. First Quarter 2025 Financial Results Total Revenue. Total revenue was $166.8 million for the first quarter of 2025, which consisted of $130.2 million in U.S. net product revenue of SYFOVRE, $19.7 million in U.S. net product revenue of EMPAVELI and $16.9 million in licensing and other revenue associated with the Sobi collaboration. Total revenue was $172.3 million for the first quarter of 2024, which consisted of $137.5 million in U.S. net product revenue of SYFOVRE, $25.6 million in U.S. net product revenue of EMPAVELI and $9.3 million in licensing and other revenue associated with the Sobi collaboration. Cost of Sales. Cost of sales was $34.4 million for the first quarter of 2025, compared to $20.2 million for the first quarter of 2024. The increase in cost of sales was primarily driven by higher volumes of product supplied to Sobi and an increase in expenses incurred related to excess, obsolete or scrapped inventory. R&D Expenses. R&D expenses were $86.4 million for the first quarter of 2025, compared to $84.7 million for the first quarter in 2024. The increase in R&D expenses was primarily attributable to an increase in non-program specific external costs and compensation and related personnel costs, partially offset by a decrease in program-specific external costs. Selling, General and Administrative (SG&A) Expenses. SG&A expenses were $129.3 million for the first quarter of 2025, compared to $129.5 million for the first quarter in 2024. Net Loss. Apellis reported a net loss of $92.2 million for the first quarter of 2025 compared to a net loss of $66.4 million for the same period in 2024. Cash. As of March 31, 2025, Apellis had $358.4 million in cash and cash equivalents, compared to $411.3 million in cash and cash equivalents as of December 31, 2024. Apellis anticipates its cash, combined with future product sales and ex-US royalties, will be sufficient to fund our business to profitability. Conference Call and WebcastApellis will host a conference call and webcast to discuss its first quarter 2025 financial results and business highlights today, May 7, 2025, 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 and Australia. 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 approved for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) in the United States, European Union, and other countries globally. The therapy is also under investigation for several other rare diseases across hematology and nephrology. 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 accompanying full Prescribing 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 excipientsFor 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 www.empavelirems.com or 1-888-343-7073. Infusion-Related Reactions Systemic hypersensitivity reactions (e.g., facial swelling, rash, urticaria) have occurred in patients treated with EMPAVELI. One patient (less than 1% in clinical studies) experienced a serious allergic reaction which resolved after treatment with antihistamines. 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 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 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. 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 that combines courageous science and compassion 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 approved medicines targeting C3. These include the first-ever therapy for geographic atrophy, a leading cause of blindness around the world. We believe we have only begun to unlock the potential of targeting C3 across many serious diseases. For more information, please visit http://apellis.com or follow us on X (formerly Twitter) and LinkedIn. Apellis Forward-Looking StatementStatements 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; whether systemic pegcetacoplan will receive approval from the FDA or equivalent foreign regulatory agencies for C3G and IC-MPGN or any other indication when expected or at all; 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 SYFOVRE will receive approval from foreign regulatory agencies for GA when expected or at all; whether the Company’s clinical trials will be completed 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 period for which the Company believes that its cash resources will be sufficient to fund its operations; 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 28, 2025 and the risks described 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:Lissa Pavlukmedia@apellis.com617.977.6764 Investor Contact:Neil Carnahan, CFAneil.carnahan@apellis.com617.977.5703 APELLIS PHARMACEUTICALS, INC.CONDENSED CONSOLIDATED BALANCE SHEETS(Unaudited)(Amounts in thousands, except per share amounts) March 31, December 31, 2025 2024 Assets Current assets: Cash and cash equivalents $358,393 $411,290 Accounts receivable, net 235,246 264,926 Inventory 82,468 81,404 Prepaid assets 37,104 18,368 Restricted cash 1,434 1,322 Other current assets 13,073 11,644 Total current assets 727,718 788,954 Non-current assets: Right-of-use assets 15,251 16,083 Property and equipment, net 2,514 2,952 Long-term inventory 60,652 75,713 Other assets 1,150 1,349 Total assets $807,285 $885,051 Liabilities and Stockholders' Equity Current liabilities: Accounts payable $55,287 $38,572 Accrued expenses 116,146 140,184 Current portion of lease liabilities 6,944 6,753 Total current liabilities 178,377 185,509 Long-term liabilities: Long-term credit facility 360,001 359,489 Convertible senior notes 93,421 93,341 Lease liabilities 9,186 10,201 Other liabilities 2,084 7,972 Total liabilities 643,069 656,512 Commitments and contingencies (Note 11) Stockholders' equity: Preferred stock, $0.0001 par value; 10,000 shares authorized, and no shares issued and outstanding at March 31, 2025 and December 31, 2024 — — Common stock, $0.0001 par value; 200,000 shares authorized at March 31, 2025 and December 31, 2024; 125,661 shares issued and outstanding at March 31, 2025, and 124,495 shares issued and outstanding at December 31, 2024 12 12 Additional paid-in capital 3,294,849 3,267,201 Accumulated other comprehensive loss (3,054) (3,308)Accumulated deficit (3,127,591) (3,035,366)Total stockholders' equity 164,216 228,539 Total liabilities and stockholders' equity $807,285 $885,051 APELLIS PHARMACEUTICALS, INC.CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS(Unaudited)(Amounts in thousands, except per share amounts) For the Three Months Ended March 31, 2025 2024 Revenue: Product revenue, net$149,900 $163,075 Licensing and other revenue 16,897 9,250 Total revenue: 166,797 172,325 Operating expenses: Cost of sales 34,360 20,209 Research and development 86,420 84,701 Selling, general and administrative 129,345 129,505 Operating expenses: 250,125 234,415 Net operating loss (83,328) (62,090)Interest income 2,658 3,303 Interest expense (11,049) (6,967)Other expense, net (165) (499)Net loss before taxes (91,884) (66,253)Income tax expense 341 170 Net loss$(92,225) $(66,423)Other comprehensive gain: Foreign currency translation 254 17 Total other comprehensive income 254 17 Comprehensive loss, net of tax$(91,971) $(66,406)Net loss per common share, basic and diluted$(0.74) $(0.54)Weighted-average number of common shares used in net loss per common share, basic and diluted 125,453 122,957

Apellis Pharmaceuticals Reports First Quarter 2025 Financial Results

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