Apellis Pharmaceuticals Reports Third Quarter 2025 Financial Results

• Generated $459 million in 3Q 2025 revenues, including $178 million in U.S. net product sales
  
• Received 152 new patient start forms for EMPAVELI^® (pegcetacoplan) in the first two months since launch in C3G and primary IC-MPGN
  
• Reported EMPAVELI U.S. net product revenue of $27 million, reflecting strong early launch in C3G and primary IC-MPGN and continued high patient compliance in PNH
  
• SYFOVRE^® (pegcetacoplan injection) total injection demand grew 4% quarter-over-quarter, with U.S. net product revenue of $151 million
  
• Cash and cash equivalents of $479 million as of September 30, 2025; existing cash expected to be sufficient to fund business to sustainable profitability
  
• Management to host conference call today at 8:30 a.m. ET

WALTHAM, Mass., Oct. 30, 2025 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS), today announced its third quarter 2025 financial results and business highlights.

“The third quarter was marked by strong execution and meaningful progress across our commercial and development portfolio. We were thrilled to receive our third regulatory approval in just four years, introducing a first-in-class C3 therapy for patients with C3G and primary IC-MPGN, many of whom previously had no available treatment options. The positive reception from the nephrology community reflects recognition of EMPAVELI’s compelling efficacy and safety profile, and strengthens our confidence in its potential to become the treatment of choice for patients,” said Cedric Francois, M.D., Ph.D., chief executive officer at Apellis. “At the same time, SYFOVRE continues to lead the geographic atrophy market and deliver a steady, durable revenue stream that supports our long-term growth ambitions. Combined with our strong financial position, these achievements enable us to enter the fourth quarter and 2026 with a solid foundation and clear momentum for continued growth.”

Third Quarter 2025 Business Highlights and Upcoming Milestones

Maximizing EMPAVELI’s impact in rare diseases

• Recorded $26.8 million in EMPAVELI U.S. net product revenue for the third quarter 2025.
• C3 glomerulopathy (C3G) and primary immune complex glomerulonephritis (IC-MPGN):
  • On July 28, 2025, EMPAVELI was approved by the U.S. Food and Drug Administration (FDA) as the first treatment for C3G and primary IC-MPGN for patients 12 and older. Approval was based on the trifecta of positive outcomes in the Phase 3 VALIANT study including a 68% reduction in proteinuria, stabilization of kidney function, and substantial clearance of C3 deposits as measured by C3 staining, compared to placebo.
  • Launch is underway with 152 patient start forms received as of September 30, 2025. This number includes approximately 50 patients from the Company’s early access program who are in the process of transitioning to commercial product.
  • Sobi, the Company’s ex-U.S. commercialization partner, expects an opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for its indication extension application for Aspaveli (the brand name for EMPAVELI outside the U.S.) in C3G and primary IC-MPGN before year-end 2025.
  • Seven abstracts were accepted for presentation at the upcoming American Society of Nephrology (ASN) Kidney Week, including new 52-week data from the Phase 3 VALIANT study that reinforce the robust and sustained efficacy profile of EMPAVELI in C3G and primary IC-MPGN.
• Paroxysmal nocturnal hemoglobinuria (PNH):
  • The Company continues to see high patient compliance rates of 97%.
• Focal segmental glomerulosclerosis (FSGS) and delayed graft function (DGF):
  • The Company expects to initiate two pivotal studies by year-end 2025, one in FSGS and one in DGF, two rare kidney diseases with significant complement pathway involvement and no approved therapies.

Transforming the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD)

• SYFOVRE:
  • Generated $150.9 million in SYFOVRE U.S. net product revenue in the third quarter of 2025
    • Total injections grew 4% quarter-over-quarter.
    • SYFOVRE remains the market leader in GA with total market share exceeding an estimated 60% and 52% of new patient starts during the quarter.
    • Utilization of SYFOVRE free goods remained elevated during the quarter and impacted revenue by approximately $15 million.
    • Delivered approximately 101K SYFOVRE doses to physician offices, including ~86K commercial doses and ~15K free goods doses.
  • 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.
    

Business Update

• Apellis and Sobi announced a capped royalty purchase agreement in July in which Apellis will receive up to $300 million in exchange for 90% of Apellis’ future ex-U.S. royalties for Aspaveli.
  • Per the companies’ 2020 collaboration agreement, Apellis is eligible for tiered royalties on ex-U.S. sales of Aspaveli ranging from high teens to high twenties.
  • Under the terms of the royalty purchase agreement, Sobi acquired 90% of Apellis’ ex-U.S. royalties for Aspaveli for $275 million in cash. Apellis is also eligible for up to $25 million in milestone payments upon EMA approval of Aspaveli for C3G and IC-MPGN.
  • The agreement is subject to defined caps tied to Aspaveli’s performance. Sobi retains 90% of ex-U.S. royalties until these caps are achieved, after which 100% of all ex-U.S. royalties revert to Apellis.

Third Quarter 2025 Financial Results

Total Revenue

Total revenue was $458.6 million for the third quarter of 2025, which consisted of $150.9 million of SYFOVRE U.S. net product revenue, $26.8 million of EMPAVELI U.S. net product revenue, the $275.0 million upfront payment from Sobi in connection with the Aspaveli royalty purchase agreement, and $5.8 million in licensing and other revenue associated with the Sobi collaboration. Total revenue was $196.8 million for the third quarter of 2024, which consisted of $152.0 million of SYFOVRE U.S. net product revenue, $24.6 million in EMPAVELI U.S. net product revenue, and $20.3 million in licensing and other revenue associated with the Sobi collaboration.

Cost of Sales

Cost of sales was $24.5 million for the third quarter 2025, compared to $33.6 million for the same period in 2024. The decrease in cost of sales was primarily driven by lower volumes of product supplied to Sobi, a decrease in expenses incurred related to excess, obsolete or scrapped inventory and a decrease due to costs incurred in connection with cancellable purchase commitments. The decreases were partially offset by a higher volume from commercial sales and product provided under our patient assistance programs.

R&D Expenses

R&D expenses were $68.2 million for the third quarter of 2025, compared to $88.6 million for the same period in 2024. The decrease in R&D expenses was primarily driven by lower program-specific and non-program-specific external costs, and lower compensation and related personnel costs.

Selling, General and Administrative (SG&A) Expenses

SG&A expenses were $142.7 million for the third quarter of 2025, compared to $122.0 million for the same period in 2024. The increase in SG&A was primarily driven by higher general commercial activities, personnel costs and general and administrative expenses, including office expenses, travel expenses, insurance expenses, professional and consulting fees, and other expenses, partially offset by lower personnel costs and lower factoring fees.

Net Income

Apellis reported a net income of $215.7 million for the third quarter 2025, driven by the one-time $275.0 million upfront payment from Sobi in connection with the Aspaveli royalty purchase agreement. This compared to a net loss of $57.4 million for the same period in 2024.

Cash

As of September 30, 2025, Apellis had $479.2 million in cash and cash equivalents, compared to $411.3 million in cash and cash equivalents as of December 31, 2024. Based on its strong cash position, the Company elected to discontinue factoring its receivables during the quarter. Apellis now carries the incremental $80.6 million in receivables from the first three quarters of the year on its balance sheet and expects to realize cost savings of approximately $4.8 million on a go-forward annual basis. The Company continues to expect that its cash, 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 third quarter 2025 financial results and business highlights today, October 30, 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 90 days following the event.

About SYFOVRE^® (pegcetacoplan injection)

SYFOVRE^® (pegcetacoplan injection) is the first-ever approved therapy for geographic atrophy secondary to age-related macular degeneration. 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 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 and older, to reduce proteinuria. EMPAVELI is also approved for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH) in the United States, European Union, and other countries globally, and is under investigation for other 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 its opt-in rights for future development programs are unchanged, exercisable at any time prior to commercialization. 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.

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 www.empavelirems.com 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 http://apellis.com 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; whether systemic pegcetacoplan will receive approval from foreign regulatory agencies for C3G and primary IC-MPGN; 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 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:
Tracy Vineis
media@apellis.com
617.420.4839

Investor Contact:
Eva Stroynowski
[email protected]
617.938.6229