Apellis Pharmaceuticals Reports Fourth Quarter and Full Year 2024 Financial Results
Apellis Pharmaceuticals (APLS) reported strong financial results for FY2024, with total revenue reaching $781.4 million, representing 97% year-over-year growth. The company's flagship products showed robust performance: SYFOVRE® generated $611.9 million in net product revenue, while EMPAVELI® contributed $98.1 million.
Key highlights include the submission of a supplemental new drug application for EMPAVELI in C3G and IC-MPGN, with anticipated U.S. launch in H2 2025. The company delivered approximately 94,000 SYFOVRE doses in Q4 2024, with over 510,000 injections administered since launch. The company reported a significantly reduced net loss of $197.9 million for FY2024, compared to $528.6 million in 2023.
With $411.3 million in cash and cash equivalents as of December 31, 2024, combined with expected product revenues, Apellis anticipates sufficient funding to reach profitability.
Apellis Pharmaceuticals (APLS) ha riportato risultati finanziari solidi per l'anno fiscale 2024, con entrate totali che hanno raggiunto 781,4 milioni di dollari, rappresentando una crescita del 97% rispetto all'anno precedente. I prodotti di punta dell'azienda hanno mostrato una performance robusta: SYFOVRE® ha generato 611,9 milioni di dollari in ricavi netti da prodotto, mentre EMPAVELI® ha contribuito con 98,1 milioni di dollari.
I punti salienti includono la presentazione di una domanda supplementare per un nuovo farmaco per EMPAVELI in C3G e IC-MPGN, con un lancio previsto negli Stati Uniti nel secondo semestre del 2025. L'azienda ha consegnato circa 94.000 dosi di SYFOVRE nel quarto trimestre del 2024, con oltre 510.000 iniezioni somministrate dal lancio. L'azienda ha riportato una perdita netta significativamente ridotta di 197,9 milioni di dollari per l'anno fiscale 2024, rispetto ai 528,6 milioni di dollari del 2023.
Con 411,3 milioni di dollari in contante e equivalenti di contante al 31 dicembre 2024, insieme ai ricavi previsti dai prodotti, Apellis prevede di avere finanziamenti sufficienti per raggiungere la redditività.
Apellis Pharmaceuticals (APLS) informó resultados financieros sólidos para el año fiscal 2024, con ingresos totales alcanzando 781.4 millones de dólares, lo que representa un crecimiento del 97% interanual. Los productos insignia de la compañía mostraron un rendimiento robusto: SYFOVRE® generó 611.9 millones de dólares en ingresos netos por producto, mientras que EMPAVELI® contribuyó con 98.1 millones de dólares.
Los aspectos destacados incluyen la presentación de una solicitud suplementaria de nuevo medicamento para EMPAVELI en C3G e IC-MPGN, con un lanzamiento anticipado en EE.UU. en la segunda mitad de 2025. La empresa entregó aproximadamente 94,000 dosis de SYFOVRE en el cuarto trimestre de 2024, con más de 510,000 inyecciones administradas desde su lanzamiento. La compañía reportó una pérdida neta significativamente reducida de 197.9 millones de dólares para el año fiscal 2024, en comparación con 528.6 millones de dólares en 2023.
Con 411.3 millones de dólares en efectivo y equivalentes de efectivo al 31 de diciembre de 2024, junto con los ingresos por productos esperados, Apellis anticipa tener suficiente financiamiento para alcanzar la rentabilidad.
Apellis Pharmaceuticals (APLS)는 2024 회계연도에 대한 강력한 재무 결과를 보고했으며, 총 수익은 7억 8140만 달러에 달하며, 이는 전년 대비 97% 성장한 수치입니다. 회사의 주요 제품들은 강력한 성과를 보였으며: SYFOVRE®는 6억 1190만 달러의 순제품 수익을 창출했고, EMPAVELI®는 9810만 달러를 기여했습니다.
주요 하이라이트로는 C3G 및 IC-MPGN에 대한 EMPAVELI의 보충 신약 신청서 제출이 있으며, 2025년 하반기 미국 출시가 예상됩니다. 회사는 2024년 4분기에 약 94,000개의 SYFOVRE 용량을 제공했으며, 출시 이후 51만 건 이상의 주사가 시행되었습니다. 회사는 2024 회계연도에 1억 9790만 달러의 순손실을 기록했으며, 이는 2023년의 5억 2860만 달러에 비해 크게 감소한 수치입니다.
2024년 12월 31일 기준으로 4억 1130만 달러의 현금 및 현금성 자산을 보유하고 있으며, 예상되는 제품 수익과 함께 Apellis는 수익성에 도달하기 위한 충분한 자금을 확보할 것으로 예상하고 있습니다.
Apellis Pharmaceuticals (APLS) a annoncé des résultats financiers solides pour l'exercice 2024, avec un chiffre d'affaires total atteignant 781,4 millions de dollars, représentant une croissance de 97 % par rapport à l'année précédente. Les produits phares de l'entreprise ont montré une performance robuste : SYFOVRE® a généré 611,9 millions de dollars de revenus nets, tandis que EMPAVELI® a contribué à hauteur de 98,1 millions de dollars.
Les points clés incluent la soumission d'une demande de nouveau médicament complémentaire pour EMPAVELI dans le C3G et l'IC-MPGN, avec un lancement prévu aux États-Unis au second semestre 2025. L'entreprise a livré environ 94 000 doses de SYFOVRE au quatrième trimestre 2024, avec plus de 510 000 injections administrées depuis le lancement. L'entreprise a signalé une perte nette considérablement réduite de 197,9 millions de dollars pour l'exercice 2024, par rapport à 528,6 millions de dollars en 2023.
Avec 411,3 millions de dollars en liquidités et équivalents de liquidités au 31 décembre 2024, combiné aux revenus de produits attendus, Apellis anticipe un financement suffisant pour atteindre la rentabilité.
Apellis Pharmaceuticals (APLS) hat starke Finanzzahlen für das Geschäftsjahr 2024 gemeldet, mit einem Gesamtumsatz von 781,4 Millionen Dollar, was einem Wachstum von 97% im Vergleich zum Vorjahr entspricht. Die Hauptprodukte des Unternehmens zeigten eine robuste Leistung: SYFOVRE® erzielte 611,9 Millionen Dollar an Nettoumsatz, während EMPAVELI® 98,1 Millionen Dollar beitrug.
Zu den wichtigsten Höhepunkten gehört die Einreichung eines ergänzenden Antrags für ein neues Medikament für EMPAVELI bei C3G und IC-MPGN, mit einem erwarteten US-Start in der zweiten Hälfte von 2025. Das Unternehmen lieferte im vierten Quartal 2024 etwa 94.000 Dosen SYFOVRE aus, wobei seit dem Start über 510.000 Injektionen verabreicht wurden. Das Unternehmen meldete einen erheblich reduzierten Nettoverlust von 197,9 Millionen Dollar für das Geschäftsjahr 2024, im Vergleich zu 528,6 Millionen Dollar im Jahr 2023.
Mit 411,3 Millionen Dollar an Bargeld und liquiden Mitteln zum 31. Dezember 2024, zusammen mit den erwarteten Produktumsätzen, erwartet Apellis ausreichende Mittel, um die Rentabilität zu erreichen.
- 97% year-over-year revenue growth to $781.4M in 2024
- Strong SYFOVRE sales of $611.9M in 2024
- Net loss reduced by 63% to $197.9M in 2024
- Cash position increased to $411.3M from $351.2M YoY
- High patient compliance rate of 97% for EMPAVELI
- R&D expenses increased to $76.4M in Q4 2024 from $69.3M in Q4 2023
- EMPAVELI Q4 revenue declined to $23.4M from $24.4M YoY
Insights
Apellis delivered impressive financial performance in 2024 with
The significant narrowing of net losses is particularly noteworthy—Q4 losses improved to
The company's cash position of
Apellis's two-product commercial portfolio now appears well-established, with SYFOVRE dominating the geographic atrophy market as first-to-market therapy and EMPAVELI maintaining stable revenue in PNH. The pending sNDA for EMPAVELI in C3G and IC-MPGN represents a meaningful potential revenue expansion opportunity in 2025-2026, with two additional Phase 3 programs advancing for further indications.
From a clinical development perspective, Apellis is systematically executing on its complement-focused pipeline strategy. The sNDA submission for EMPAVELI in C3G and IC-MPGN represents a significant milestone following what management characterized as "unprecedented Phase 3 results" in these rare kidney diseases with substantial unmet needs.
The 48-month GALE extension data for SYFOVRE demonstrates important long-term efficacy with preservation of approximately 1.5 disc areas of retinal tissue in nonsubfoveal patients receiving monthly dosing. This preservation, equivalent to two foveal areas, provides compelling evidence for early intervention with SYFOVRE.
The planned initiation of the APL-3007 (siRNA) + SYFOVRE combination study represents an intriguing next-generation approach, potentially offering more comprehensive complement inhibition across both the retina and choroid. This could address any remaining disease activity not fully controlled by SYFOVRE alone.
The company's expansion into two additional kidney indications—FSGS and DGF—is scientifically rational given the established role of complement dysregulation in these conditions. With no currently approved therapies for either indication, successful development could position EMPAVELI as the standard of care across multiple complement-mediated kidney diseases.
The preclinical research for one-time FcRn treatment using Beam's gene editing technology represents a longer-term strategic investment in potentially transformative therapeutic approaches leveraging Apellis's complement expertise.
- Reported
$781.4 million in full year 2024 revenues, representing97% year-over-year growth- SYFOVRE® (pegcetacoplan injection) full year 2024 net product revenue of
$611.9 million - EMPAVELI® (pegcetacoplan) full year 2024 net product revenue of
$98.1 million
- SYFOVRE® (pegcetacoplan injection) full year 2024 net product revenue of
- 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 2025
- Cash 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.
- Reported
- 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% .
- Recorded
- 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.
- Total revenue was
- 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.
- For the full year 2023, total revenue was
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
Cash. As of December 31, 2024, Apellis had
- 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 Webcast
Apellis 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 and3% 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.
- In clinical trials, use of SYFOVRE was associated with increased rates of neovascular (wet) AMD or choroidal neovascularization (
- 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 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 (e.g., facial swelling, rash, urticaria) have occurred in patients treated with EMPAVELI. One patient (less than
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 ≥
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 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 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 Pavluk
media@apellis.com
617.977.6764
Investor Contact:
Meredith Kaya
meredith.kaya@apellis.com
617.599.8178
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Assets | |||||||
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, | — | — | |||||
Common stock, | 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 | |||||||||||
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FAQ
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