Apellis Pharmaceuticals Reports Fourth Quarter and Full Year 2024 Financial Results

Reported $781.4 million in full year 2024 revenues, representing 97% year-over-year growth SYFOVRE® (pegcetacoplan injection) full year 2024 net product revenue of $611.9 millionEMPAVELI® (pegcetacoplan) full year 2024 net product revenue of $98.1 million Submitted a supplemental new drug application (sNDA) for approval of EMPAVELI for C3G and primary IC-MPGN; U.S. launch anticipated in 2H 2025, if approved On track to initiate two Phase 3 trials of EMPAVELI in focal segmental glomerulosclerosis (FSGS) and in delayed graft function (DGF) in 2H 2025Cash and cash equivalents of $411.3 million as of December 31, 2024; 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., Feb. 28, 2025 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS), today announced its fourth quarter and full year 2024 financial results and business highlights. “Apellis made significant strides in 2024, highlighted by the continued growth of SYFOVRE and the unprecedented phase 3 results for EMPAVELI in C3G and IC-MPGN,” said Cedric Francois, M.D., Ph.D., chief executive officer at Apellis. “With two potential blockbuster products, a promising pipeline to fuel long-term growth, and a strong financial foundation, we are well positioned for continued growth in 2025 and beyond.” Fourth Quarter and Full Year 2024 Business Highlights and Upcoming Milestones Transforming the treatment of geographic atrophy (GA) secondary to age-related macular degeneration SYFOVRE: Reported $167.8 million and $611.9 million in SYFOVRE U.S. net product revenue for the fourth quarter and full year 2024, respectively.Delivered approximately 94,000 SYFOVRE doses to physician practices in the fourth quarter, including approximately 89,000 commercial vials and 4,600 samples. More than 510,000 SYFOVRE injections are estimated to have been administered since launch through December 2024, including clinical trials. Presented 48-month data from the GALE extension study at The Macula Society Annual Meeting in February 2025 demonstrating that early treatment with SYFOVRE leads to preservation of retinal tissue at magnitudes of approximately 1.5 disc areas, which is equivalent to the size of 2 foveal areas, in nonsubfoveal patients dosed monthly.Received approval in Australia from Therapeutic Goods Administration (TGA) for every-other-month treatment of adult patients with GA with an intact fovea and when central vision is threatened by GA lesion growth. APL-3007 (siRNA) + SYFOVRE Expect initiation of a Phase 2 multi-dose 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 impact in rare diseases Paroxysmal nocturnal hemoglobinuria (PNH): Recorded $23.4 million and $98.1 million in EMPAVELI U.S. net product revenue for the fourth quarter and full year 2024, respectively.Continued high patient compliance rates of 97%. C3 glomerulopathy (C3G) and primary immune complex glomerulonephritis (IC-MPGN): Submitted a sNDA for approval of EMPAVELI based on positive Phase 3 VALIANT results at six months; if approved, U.S. launch expected in 2H 2025.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) Expect initiation of two Phase 3 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 David Acheson, previously the North America senior vice president of commercial, is now serving as the executive vice president of commercial following the recent departure of Adam Townsend, chief operating officer. Mr. Acheson joined Apellis in 2019 and has led the successful U.S. launches of EMPAVELI and SYFOVRE.Keli Walbert was recently appointed to the Apellis Board of Directors. Ms. Walbert brings more than two decades of biopharmaceutical commercial leadership experience to the Board. She most recently served as executive vice president, U.S. commercial, at Horizon Therapeutics, where she was responsible for driving commercial strategy and organizational development. Fourth Quarter and Full Year 2024 Financial Results Total Revenue. Total revenue was $212.5 million for the fourth quarter of 2024, which consisted of $167.8 million in U.S. net product revenue of SYFOVRE, $23.4 million in U.S. net product revenue of EMPAVELI and $21.4 million in licensing and other revenue associated with the Sobi collaboration. Total revenue was $146.4 million for the fourth quarter of 2023, which consisted of $114.3 million in U.S. net product revenue of SYFOVRE, $24.4 million in U.S. net product revenue of EMPAVELI and $7.7 million in licensing and other revenue associated with the Sobi collaboration. For the full year 2024, total revenue was $781.4 million, which consisted of $611.8 million in U.S. net product revenue of SYFOVRE, $98.1 million in U.S. net product revenue of EMPAVELI and $71.4 million in licensing and other revenue associated with the Sobi collaboration. For the full year 2023, total revenue was $396.6 million, which consisted of $275.2 million in U.S. net product revenue of SYFOVRE, $91.0 million in U.S. net product revenue of EMPAVELI and $30.3 million in licensing and other revenue associated with the Sobi collaboration. Cost of Sales. Cost of sales was $40.9 million for the fourth quarter of 2024, compared to $19.9 million for the fourth quarter of 2023. For the full year 2024, cost of sales was $117.7 million as compared to $58.5 million for the full year 2023. 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. R&D expenses were $76.4 million for the fourth quarter of 2024, compared to $69.3 million for the fourth quarter in 2023. For the full year 2024, R&D expenses were $327.6 million compared to $354.4 million for the full year 2023. The decrease in R&D expenses for the full year ended December 31, 2024, was primarily attributable to a decrease in compensation and related personnel costs, which was partially offset by an increase in program specific external costs. Selling, General and Administrative (SG&A) Expenses. SG&A expenses were $121.5 million for the fourth quarter of 2024, compared to $141.7 million for the fourth quarter in 2023. For the full year 2024, G&A expenses were $501.1 million compared to $500.8 million for the full year 2023. The increase was primarily attributable to an increase in office expenses, an increase in factoring fees, an increase in travel expenses, and an increase in insurance expenses, which were partially offset by a decrease in professional and consulting fees and a decrease in personnel-related costs. Net Loss. Apellis reported a net loss of $36.4 million and $197.9 million for the fourth quarter and full year 2024, respectively, compared to a net loss of $88.5 million and $528.6 million for the same periods in 2023. Cash. As of December 31, 2024, Apellis had $411.3 million in cash and cash equivalents, compared to $351.2 million in cash and cash equivalents as of December 31, 2023. Apellis anticipates its cash, combined with expected product revenues, will be sufficient to fund its projected operating expenses and capital expenditures to profitability. Conference Call and WebcastApellis will host a conference call and webcast to discuss its fourth quarter and full year 2024 financial results and business highlights today, February 28, 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 ApellisApellis 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:Meredith Kayameredith.kaya@apellis.com617.599.8178 APELLIS PHARMACEUTICALS, INC.CONDENSED CONSOLIDATED BALANCE SHEETS(Amounts in thousands, except per share amounts) December 31, December 31, 2024 2023Assets Current assets: Cash and cash equivalents$411,290 $351,185 Accounts receivable 264,926 206,442 Inventory 81,404 146,362 Prepaid assets 18,368 38,820 Restricted cash 1,322 1,114 Other current assets 11,644 22,408 Total current assets 788,954 766,331 Non-current assets: Right-of-use assets 16,083 16,745 Property and equipment, net 2,952 4,345 Long-term inventory 75,713 — Other assets 1,349 1,309 Total assets$885,051 $788,730 Liabilities and Stockholders' Equity Current liabilities: Accounts payable 38,572 37,516 Accrued expenses 140,184 127,806 Current portion of development liability — 75,830 Current portion of lease liabilities 6,753 6,441 Total current liabilities 185,509 247,593 Long-term liabilities: Long-term development liability — 239,817 Long-term credit facility 359,489 — Convertible senior notes 93,341 93,033 Lease liabilities 10,201 11,454 Other liabilities 7,972 2,312 Total liabilities 656,512 594,209 Commitments and contingencies (Note 14) Stockholders' equity: — — Preferred stock, $0.0001 par value; 10,000 shares authorized and zero shares issued and outstanding at December 31, 2024 and 2023 — — Common stock, $0.0001 par value; 200,000 shares authorized at December 31, 2024 and 2023; 124,495 and 119,556 shares issued and outstanding at December 31, 2024 and 2023, respectively 12 12 Additional paid-in capital 3,267,201 3,035,539 Accumulated other comprehensive loss (3,308) (3,542)Accumulated deficit (3,035,366) (2,837,488)Total stockholders' equity 228,539 194,521 Total liabilities and stockholders' equity$885,051 $788,730 APELLIS PHARMACEUTICALS, INC.CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS(Amounts in thousands, except per share amounts) For the Three Months Ended December 31, Year Ended December 31, 2024 2023 2024 2023 Revenue: Product revenue, net$191,172 $138,655 $709,954 $366,281 Licensing and other revenue 21,356 7,722 71,413 30,310 Total revenue: 212,528 146,377 781,367 396,591 Operating expenses: Cost of sales 40,856 19,912 117,723 58,510 Research and development 76,354 69,282 327,570 354,387 Selling, general and administrative 121,482 141,701 501,053 500,815 Operating expenses: 238,692 230,895 946,346 913,712 Net operating (loss) (26,164) (84,518) (164,979) (517,121)Loss on extinguishment of development liability — — (1,949) — Interest income 3,396 4,548 12,773 20,933 Interest expense (11,534) (7,402) (40,391) (29,581)Other expense, net (1,765) 219 (2,170) (727)Net loss before taxes (36,067) (87,153) (196,716) (526,496)Income tax expense 286 1,423 1,162 2,132 Net loss$(36,353) $(88,576) $(197,878) $(528,628)Other comprehensive income/(loss): Unrealized (loss)/gain on pension plans 591 (2,618) 591 (2,618)Foreign currency translation (759) 141 (357) (49)Total other comprehensive income/(loss) (168) (2,477) 234 (2,667)Comprehensive loss, net of tax$(36,521) $(91,053) $(197,644) $(531,295)Net loss per common share, basic and diluted$(0.29) $(0.73) $(1.60) $(4.45)Weighted-average number of common shares used in net loss per common share, basic and diluted 124,523 121,232 123,905 118,678

Apellis Pharmaceuticals Reports Fourth Quarter and Full Year 2024 Financial Results

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