Apellis Pharmaceuticals (APLS) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has voted against the approval of intravitreal pegcetacoplan for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).The negative opinion of the CHMP was expected as the company previously announced a negative trend vote on the marketing authorization application (MAA) for pegcetacoplan following an oral explanation meeting in ...

WALTHAM, Mass., Jan. 26, 2024 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (NASDAQ:APLS) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a negative opinion on the marketing authorization application (MAA) of intravitreal pegcetacoplan for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). As previously announced, this opinion was expected based on a negative trend vote following an ora ...

One stock that might be an intriguing choice for investors right now is Apellis Pharmaceuticals, Inc. (APLS) . This is because this security in the Medical - Biomedical and Genetics space is seeing solid earnings estimate revision activity, and is in great company from a Zacks Industry Rank perspective.This is important because, often times, a rising tide will lift all boats in an industry, as there can be broad trends taking place in a segment that are boosting securities across the board. This is arguably ...

Apellis Pharmaceuticals (APLS) reported net product sales of approximately $138 million in the United States for the fourth quarter of 2023, up significantly year over year. The company generates product revenues from the sale of its two marketed drugs, Empaveli (pegcetacoplan) and Syfovre (pegcetacoplan injection). Its top line also comprises of licensing and other revenues.The 39% sequential increase in product revenues (from $99.2 million) was driven by strong Syfovre sales. Syfovre recorded sales of $11 ...

Apellis Pharmaceuticals, Inc. (APLS) shares ended the last trading session 14.7% higher at $68.35. The jump came on an impressive volume with a higher-than-average number of shares changing hands in the session. This compares to the stock's 5% loss over the past four weeks.The sudden rise in the stock price can be attributed to the strong preliminary net product revenues reported in the United States for the fourth quarter and full year 2023. Apellis' marketed portfolio of drugs comprise Empaveli (pegcetaco ...

Financial Data and Key Metrics Changes - Total revenue for Q3 2023 was $110 million, consisting of $24 million from EMPAVELI U.S. net product revenue, $75 million from SYFOVRE U.S. net product revenue, and $11 million in collaboration revenue from Sobi [24][25] - R&D expenses were $79 million, G&A expenses were $146 million, resulting in a net loss of $140 million [25] - Cash and cash equivalents as of September 30, 2023, were $452 million, with an expected cash runway extending into at least the second quarter of 2025 [26] Business Line Data and Key Metrics Changes - SYFOVRE generated $75 million in U.S. net product revenue in Q3 2023, up approximately 12% quarter-over-quarter, totaling over $160 million in the first seven months since launch [6][13] - EMPAVELI generated $24 million in U.S. net product revenue for Q3 2023, with a year-to-date total of $67 million [9][16] Market Data and Key Metrics Changes - Over 100,000 vials of SYFOVRE have been distributed since launch, indicating strong demand and positive impact on patients [6][13] - The estimated rate of retinal vasculitis with SYFOVRE remains rare at 0.01%, with a significantly lower rate of irreversible vision loss [7][31] Company Strategy and Development Direction - The company is focused on maximizing SYFOVRE's global leadership in geographic atrophy (GA) and streamlining the EMPAVELI business, with a restructuring expected to yield cost savings of up to $300 million through 2024 [11][12] - Plans to launch SYFOVRE in Europe are underway, with a submission for reimbursement in the UK and expectations for a decision in the first half of 2024 [15][66] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth trajectory of SYFOVRE and EMPAVELI, highlighting a rebound in demand and positive feedback from the medical community [27][28] - The company anticipates continued growth in the PNH market with EMPAVELI and is optimistic about the upcoming European Medicines Agency decision for SYFOVRE [8][66] Other Important Information - The company has received FDA approval for the EMPAVELI Injector, enhancing patient experience and simplifying administration [9] - Management noted that the ongoing efficiencies from restructuring will not be reflected in operating expenses until 2024 [26] Q&A Session Summary Question: Update on vials shipped and doses given - Management indicated that approximately 37,000 commercial vials were shipped in Q3, with an estimated 1 to 1.5 weeks of demand vials sitting in refrigerators [28][30] Question: Competitive landscape and feedback from the field - Management noted that feedback from physicians has been relatively quiet regarding competition, and they remain focused on executing their plan for SYFOVRE [33][36] Question: Utilization breakdown of SYFOVRE - Management reported continued enthusiasm from physicians, with double-digit new accounts starting SYFOVRE every week since launch [40][42] Question: Rate of vasculitis and updates - Management confirmed that the rate of vasculitis remains stable and low, with no individual case updates planned unless there are significant changes [53][55] Question: European market opportunity and physician feedback - Management expressed confidence in the European approval process and noted that KOLs in Europe are well-informed and supportive of SYFOVRE [62][66]

Third Quarter 2023 Financial Results Conference Call Apellis Participants CEDRI C F RANCO I S, M. D. , Ph . D. Co-Founder, President & Chief Executive Officer AD AM TO W NS E ND ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-38276 APELLIS PHARMACEUTICALS, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 27-1537290 (State or othe ...

Apellis Pharmaceuticals, Inc. (NASDAQ:APLS) Q2 2023 Earnings Conference Call July 31, 2023 8:30 AM ET Company Participants Dr. Cedric Francois - Co-Founder and CEO Tim Sullivan - CFO Adam Townsend - CCO Dr. Caroline Baumal - CMO Meredith Kaya - SVP, IR Conference Call Participants Jonathan Miller - Evercore ISI Tazeen Ahmad - Bank of America Anupam Rama - JPMorgan Colleen Kusy - Robert W. Baird Yigal Nochomovitz - Citigroup Steven Seedhouse - Raymond James Phil Nadeau - TD Cowen Justin Kim - Oppenheimer & C ...

SYFOVRE Safety and Usage - Over 68,000 vials of SYFOVRE have been distributed since launch[6] - There have been seven confirmed reports of retinal vasculitis (RV) in the real world, and one additional reported event is being evaluated[6] - Market research indicates that 13 retina specialists surveyed plan to continue using SYFOVRE as they had been prior to the vasculitis events[9] - Manufacturing processes and drug product quality assessments found no single manufacturing lot implicated, no manufacturing issues impacting product quality, no quality issues, and no contaminants discovered[8] Financial Performance - Apellis' cash of $616 million as of June 30, 2023, combined with expected revenues and Sobi reimbursements, is expected to fund operations into Q1 2025[13] - EMPAVELI U S Net Product Sales were $22.3 million in 2023, compared to $15.7 million in 2022[14] - SYFOVRE U S Net Product Sales reached $67.3 million[14] - Total revenue was $95.0 million, compared to $16.3 million in 2022[14] - Net loss was $(122.0) million, compared to $(156.0) million in 2022[14] Clinical Trial Data - SYFOVRE continues to show increasing effects over time in the GALE long-term extension study[15]