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5/25/25 , 11:10 AM Apellis Pharmaceuticals Reports Third Quarter 2021 Financial Results - Apellis Pharmaceuticals , Inc. Release Details Apellis Pharmaceuticals Reports Third Quarter 2021 Financial Results November 8 , 2021 Generated $ 5.3 million in EMPAVELITM ( pegcetacoplan ) net product revenues Presented Phase 3 DERBY and OAKS results in geographic atrophy ( GA ) ; on track for NDA submission in 1H 2022 Received positive CHMP opinion for pegcetacoplan for treatment of PNH ; expect decision regarding approval by European Commission by end of 2021 Conference call scheduled today at 4:30 p.m. ET WALTHAM , Mass . , Nov. 08 , 2021 ( GLOBE NEWSWIRE ) -- Apellis Pharmaceuticals , Inc. ( Nasdaq : APLS ) , a global biopharmaceutical company and leader in complement , today announced its third quarter 2021 financial results and business highlights . " The third quarter was another exceptional period for Apellis , highlighted by successful commercial execution with EMPAVELI in PNH , the Phase 3 DERBY and OAKS results in geographic atrophy , and continued momentum advancing our broader pipeline , " said Cedric Francois , M.D. , Ph.D. , co - founder and chief executive officer of Apellis . " Our commercial launch of EMPAVELI is off to a strong start in the U.S. and we expect a decision regarding approval by the European Commission by the end of this year as we seek to elevate the standard of care in PNH worldwide . " Dr. Francois continued , " With the DERBY and OAKS data , intravitreal pegcetacoplan has the potential to become the first treatment for patients living with geographic atrophy , a leading cause of blindness worldwide . We believe we have a robust data package that supports approval and remain on track to submit our New Drug Application to the FDA in the first half of 2022. Behind our lead programs , we are continuing to progress our broad pipeline addressing complement- driven diseases in rare disease , neurology , and ophthalmology . " Third Quarter 2021 Business Highlights and Upcoming Milestones : Paroxysmal Nocturnal Hemoglobinuria ( PNH ) Commercial Progress Apellis recorded $ 5.3 million in EMPAVELIT ( pegcetacoplan ) net product revenue for the third quarter of 2021 . In October 2021 , Apellis and Sobi announced that the Committee for Medicinal Products for Human Use ( CHMP ) of the European Medicines Agency ( EMA ) had adopted a positive opinion recommending the marketing authorization of systemic pegcetacoplan for the treatment of adults with PNH who are anemic after treatment with a C5 inhibitor for at least three months . A decision regarding approval is expected by the European Commission by the end of 2021 . Apellis is eligible for a $ 50.0 million milestone payment from Sobi upon first regulatory and reimbursement approval . If systemic pegcetacoplan is approved by the EMA in 2021 , Apellis expects to achieve this milestone in the first half of 2022 . Rare Disease R & D Highlights Immune complex membranoproliferative glomerulonephritis ( IC - MPGN ) and C3 glomerulopathy ( C3G ) : Apellis expects to initiate a Phase 3 study in the fourth quarter of 2021 . Cold agglutinin disease ( CAD ) : Sobi plans to initiate a Phase 3 study in the fourth quarter of 2021 . Hematopoietic stem cell transplantation - associated thrombotic microangiopathy ( HSCT - TMA ) : Sobi plans to initiate a potentially registrational program in the fourth quarter of 2021 . Amyotrophic lateral sclerosis ( ALS ) : Apellis now expects to complete enrollment for its ongoing and potentially registrational Phase 2 MERIDIAN study in the first half of 2022 ( previously end of 2021 ) . Enrollment is slower than expected due to the COVID - 19 pandemic and competing ongoing trials recruiting in ALS . https://investors.apellis.com/news-releases/news-release-details/apellis-pharmaceuticals-reports-third-quarter-2021-financial 1/7