Apellis Pharmaceuticals (APLS) Company Report

Autolus Therapeutics presented preliminary Phase 1 CARLYSLE trial data for obecabtagene autoleucel (obe-cel) in patients with severe refractory systemic lupus erythematosus (srSLE) at the American Society of Hematology (ASH) Annual Meeting on December 8, 2025.
The data indicated deep, durable responses in the 50 million cell dose level cohort, with 50% of patients achieving CRR and 83% achieving DORIS. All patients demonstrated deep B-cell depletion after infusion, suggesting an immune reset.
Obe-cel was well tolerated, with no ICANS or high-grade CRS observed, and the 50M dose has been selected as the recommended Phase 2 dose.
Autolus has aligned with the FDA on a Phase 2 trial design in lupus nephritis (LN) and a potential registrational path, with the LUMINA trial now enrolling.
Obe-cel, marketed as AUCATZYL®, was FDA-approved in 2024 for adult relapsed or refractory B-cell precursor acute lymphoblastic leukemia and received conditional marketing authorization in the UK and EU in 2025.

Dec 8, 2025, 9:05 PM

Press Release

APLS Provides Updates on Empaveli and Syfovre Launches, Pipeline

APLS

Product Launch

Guidance Update

New Projects/Investments

The launch of Empaveli for C3G and IC-MPGN is progressing as expected, with 152 new patient starts in Q3 2025 and a projected 225 or more by the end of 2025. The company estimates the disease population at 5,000 patients and reports a robust patient pipeline.
Empaveli holds a unique position as the only approved product for pediatric and post-transplant C3G/IC-MPGN patients, where treatment urgency is notably higher. Increased adoption in the transplant population is anticipated throughout 2026 as it becomes a standard of care.
The Syfovre market faced significant headwinds in 2025 due to a lack of foundation money for copay assistance, which disrupted retina practices and led to a pause in new geographic atrophy (GA) patient enrollments. However, practices are adapting to this new dynamic, and the company expects a new normalcy to emerge, with a focus on patients with advanced GA.
Key tailwinds for Syfovre in 2026 and beyond include long-term GALE data demonstrating the potential to save 1.5 years of vision over five years of treatment, and the expected launch of prefilled syringes by late 2026, which is projected to significantly enhance adoption by streamlining clinic workflow.
Syfovre maintains a dominant position in total prescriptions, with new prescriptions consistently in the mid-50% range compared to its competitor's 45%. The company is also advancing Abelast 3007 (RNAi) in Phase 1, aiming for every three-month subcutaneous dosing to improve treatment impact.

Dec 3, 2025, 7:10 PM

Transcript

Apellis Discusses Empaveli Launch Progress and SYFOVRE Market Dynamics

APLS

Product Launch

New Projects/Investments

Demand Weakening

Empaveli's launch for C3G and IC-MPGN is progressing as expected, with 152 new patient starts in Q3 and an anticipated 225 or more start forms by year-end. The company estimates the patient population at 5,000.
SYFOVRE's market adoption has faced headwinds due to disruptions in foundation assistance for patient copays, which impacted retina practices' ability to enroll new geographic atrophy patients.
Apellis anticipates that the introduction of prefilled syringes for SYFOVRE, expected towards the end of 2026, will significantly boost adoption by improving clinic workflow.
Despite market challenges, SYFOVRE maintains a dominant position in total prescriptions, holding approximately mid-50% of new prescriptions compared to competitors.
Apellis is also developing Abelast 3007 (RNAi), a subcutaneous injection aimed at enabling every three-month dosing for geographic atrophy and enhancing treatment impact.

Dec 3, 2025, 7:10 PM

Transcript

Apellis Pharmaceuticals Provides Update on Empaveli Launch and Syfovre Performance

APLS

Product Launch

New Projects/Investments

Guidance Update

Apellis Pharmaceuticals is nearing cash OpEx neutrality and holds over $450 million in cash, expressing confidence in achieving profitability based on its commercial products and expense profile.
The company's drug, Empaveli, recently received approval for C3 glomerulopathy (C3G) and immune complex membranoproliferative glomerulonephritis (IC-MPGN), demonstrating a 68% reduction in proteinuria in clinical trials. The launch is progressing well, with 225 start forms by the end of the first full quarter, representing 5% penetration of the estimated 5,000 US patient population.
Syfovre, for geographic atrophy (GA), maintained its market leadership with over 60% market share overall and 55% on new injections in early 2025, despite a challenging 2025 for retina practices due to a lack of patient copay assistance, which resulted in approximately $40 million in free goods in the first three quarters of 2025. Long-term data indicates Syfovre can save about a year and a half worth of vision loss over five years.
Apellis is advancing its pipeline with Phase 3 trials for Empaveli in FSGS (13,000 patients) and delayed graft function, and a registrational Phase 2 trial for an siRNA combo with Syfovre to potentially enable every three-month dosing and further slow GA progression. The company is also developing AI-powered technology to image and track functional decline in GA patients.

Dec 2, 2025, 7:30 PM

Transcript

Apellis Pharmaceuticals Discusses Product Performance, Financial Health, and Future Growth Initiatives

APLS

Product Launch

New Projects/Investments

Demand Weakening

Apellis Pharmaceuticals is a commercial-stage company with two approved drugs, EMPAVELI and SYFOVRE, across four indications, and is cash neutral and on a path to profitability.
EMPAVELI's launch for C3G and IC-MPGN is performing strongly, achieving close to 5% market penetration (225 start forms) after its first full quarter, with clinical data showing a 68% reduction in proteinuria.
SYFOVRE maintains its market leadership in geographic atrophy with over 60% market share and long-term data indicating it can save about 1.5 years of vision loss over five years.
The company is advancing a registrational phase 2 clinical trial for an siRNA combo with SYFOVRE, aiming for less frequent dosing (every three months) and enhanced disease progression slowdown, and is developing AI-powered imaging technology to better track retinal function.
A significant challenge for SYFOVRE has been the lack of patient copay assistance, resulting in nearly $40 million in free goods over the first three quarters of the year.

Dec 2, 2025, 7:30 PM

Transcript

Apellis Pharmaceuticals Provides Business Update and Outlook at Citi Conference

APLS

Product Launch

New Projects/Investments

Guidance Update

Apellis Pharmaceuticals reported being cash neutral and on a path to profitability, with over $450 million in cash as of the document's publication.
The company's drug, Empaveli, recently approved for C3 glomerulopathy (C3G) and immune complex membranoproliferative glomerulonephritis (IC-MPGN), has achieved 225 start forms in five months, representing 5% of the estimated 5,000-patient market in the US.
Syfovre, for geographic atrophy, maintains market leadership with over 60% market share and five-year data indicating it can save about a year and a half of vision loss.
Apellis is advancing two Phase 3 trials for FSGS (affecting 13,000 patients) and Delayed Graft Function, and a registrational Phase 2 trial for a siRNA combo with Syfovre aimed at enabling quarterly dosing and further slowing disease progression.

Dec 2, 2025, 7:30 PM

Transcript

Apellis Discusses Syfovre and Empaveli Performance and Future Outlook

APLS

Product Launch

Guidance Update

Revenue Acceleration/Inflection

Apellis's Syfovre, for geographic atrophy, has an approximate $600 million run rate and is expected to grow in the next year, despite headwinds from free product and copay funding estimated at $40 million over the first three quarters of the year.
Empaveli, with an $80-$90 million run rate for PNH, recently launched for C3G and IC-MPGN, achieving 152 start forms in the first two months and guiding for 225 or more by the end of Q4.
Syfovre injections are growing on average 5% per quarter (Q1: 4%, Q2: 6%, Q3: 4%) despite market challenges, supported by new 5-year GALE study data showing 1.5 years of saved lesion growth.
The company reported average quarterly cash usage of $5-$10 million (excluding one-timers) or about $15 million including interest expense, and holds $500 million in the bank and $350 million in receivables, indicating proximity to cash flow neutrality.

Nov 12, 2025, 7:40 PM

Transcript

Apellis Announces 5-Year GALE Data for SYFOVRE

APLS

Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) announced data from a post hoc analysis of the GALE extension study for SYFOVRE® (pegcetacoplan injection).
The results demonstrated that both every-other-month and monthly SYFOVRE delayed geographic atrophy (GA) lesion growth by approximately 1.5 years in patients with nonsubfoveal GA, compared to sham/projected sham, after five years of continuous treatment.
The safety profile of SYFOVRE through five years remained consistent with previously reported data.
SYFOVRE is the first-ever approved therapy for geographic atrophy (GA).

Nov 12, 2025, 12:00 PM

Press Release

Apellis Announces Q3 2025 Financial Results and Product Performance

APLS

Earnings

Product Launch

Revenue Acceleration/Inflection

Apellis reported total revenue of $458.6 million and net income of $215.7 million for Q3 2025, with Licensing and Other Revenue contributing $280.8 million.
SYFOVRE U.S. net product sales reached $150.9 million in Q3 2025, demonstrating 4% quarter-over-quarter injection growth and maintaining an overall GA market share exceeding 60%.
EMPAVELI U.S. net product sales were $26.8 million in Q3 2025, with 152 patient start forms received for nephrology as of September 30, 2025, following its July FDA approval for C3G and primary IC-MPGN.

Oct 30, 2025, 12:30 PM

Presentation

Apellis Pharmaceuticals Reports Q3 2025 Results and EMPAVELI Launch Progress

APLS

Earnings

Product Launch

New Projects/Investments

Apellis Pharmaceuticals reported total revenue of $459 million for Q3 2025, which included a $275 million upfront payment from Sobi, and ended the quarter with $475 million in cash and cash equivalents. Operating expenses were $235 million, a decrease from the prior year.
SYFOVRE net product revenue was $151 million in Q3 2025, with 4% sequential growth in total injection demand. The company anticipates Q4 SYFOVRE revenue to be broadly in line with Q3.
The FDA approved EMPAVELI for C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (ICMPGN), expanding its addressable market by approximately 5,000 patients. The launch has generated 152 patient start forms through September, with a projection of 225 cumulative start forms or more by year-end.
Apellis plans to initiate pivotal trials for EMPAVELI in two additional rare kidney diseases, primary focal segmental glomerulosclerosis (FSGS) and delayed graft function (DGF), by the end of the year.

Oct 30, 2025, 12:30 PM

Transcript

Earnings Transcripts

Quarterly earnings call transcripts for Apellis Pharmaceuticals.

Q3 2025

Oct 30, 2025

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Q2 2025

Jul 31, 2025

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Q1 2025

May 7, 2025

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Apellis Pharmaceuticals (APLS)

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Cedric Francois

Caroline Baumal

David Acheson

David Watson

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Mark DeLong

Nur Nicholson

Pascal Deschatelets

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Divya Rao

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Shrunatra Mishra

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Timur Ivannikov

Derek Archila

Eliana Merle

Philip Nadeau

Salveen Richter

Tazeen Ahmad

Jasmine Fels

Akash Tewari

Colin Kosse

Greg Harrison

Gregory Harrison

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Laura Chico

Nicholas Econom

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