Apellis Pharmaceuticals, Inc. (APLS) came out with a quarterly loss of $0.54 per share in line with the Zacks Consensus Estimate. This compares to loss of $1.56 per share a year ago. These figures are adjusted for non-recurring items.A quarter ago, it was expected that this company would post a loss of $0.66 per share when it actually produced a loss of $0.73, delivering a surprise of -10.61%.Over the last four quarters, the company has surpassed consensus EPS estimates just once.Apellis Pharmaceuticals, wh ...

Generated $172.3 million in 1Q 2024 revenues, including $163.1 million in U.S. net product sales $137.5 million for SYFOVRE® (pegcetacoplan injection) $25.6 million for EMPAVELI® (pegcetacoplan) Anticipates CHMP opinion for pegcetacoplan in GA no later than July 2024On track to report topline Phase 3 data with systemic pegcetacoplan in C3G / IC-MPGN in mid-2024Cash and cash equivalents of $325.9 million as of March 31, 2024; projected revenues and cash expected to be sufficient to fund operations for fores ...

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 March 31, 2024 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 Delaware 27-1537290 (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.) 100 ...

WALTHAM, Mass., May 01, 2024 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (NASDAQ:APLS) today announced that 14 abstracts, 11 of which are oral presentations, will be presented at the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting to be held May 5 - 9 in Seattle. The data continue to reinforce the robust efficacy and safety profile of SYFOVRE® (pegcetacoplan injection) for geographic atrophy (GA) secondary to age-related macular degeneration (AMD). "The 11 oral presentations ...

Apellis Pharmaceuticals Inc (NASDAQ: APLS) is down nearly 40% versus its year-to-date high but a Mizuho analyst does not see it as an opportunity to buy per se.Are you looking for signals & alerts from pro-traders? Sign-up to Invezz Signals™ for FREE. Takes 2 mins.Mizuho remains ‘neutral’ on Apellis Pharmaceuticals stockCopy link to sectionGraig Suvannavejh reiterated his “neutral” stance on the biotech stock in a recent research note.  While his $52 price target does suggest meaningful upside from here – a ...

Apellis Pharmaceuticals, Inc. (APLS) is expected to deliver a year-over-year increase in earnings on higher revenues when it reports results for the quarter ended March 2024. This widely-known consensus outlook gives a good sense of the company's earnings picture, but how the actual results compare to these estimates is a powerful factor that could impact its near-term stock price.The stock might move higher if these key numbers top expectations in the upcoming earnings report, which is expected to be relea ...

Core Viewpoint - The European Medicines Agency (EMA) has reset the review process for Apellis Pharmaceuticals' marketing authorization application for intravitreal pegcetacoplan, with an expected opinion from the Committee for Medicinal Products for Human Use (CHMP) by July 2024 [1][2]. Group 1: Regulatory Update - The EMA's decision follows a recent ruling by the Court of Justice of the European Union regarding the organization of EMA's expert groups, which affects how EMA manages competing interests among experts [2]. - The reset of the review process is procedural and does not pertain to the data package for pegcetacoplan [2]. Group 2: Company Overview - Apellis Pharmaceuticals is a global biopharmaceutical company focused on developing therapies for challenging diseases, having introduced the first new class of complement medicine in 15 years [3]. - The company has two approved medicines targeting C3, including the first therapy for geographic atrophy, a major cause of blindness globally [3].

Apellis Pharmaceuticals, Inc. (APLS) reported fourth-quarter 2023 loss of 73 cents per share, which was wider than the Zacks Consensus Estimate of a loss of 66 cents. The company had reported a loss of $1.50 per share in the year-ago quarter.Total revenues amounted to $146.4 million in the fourth quarter, matching the Zacks Consensus Estimate. In the year-ago quarter, the company had reported revenues of $22.6 million.The top line jumped almost 545% year over year owing to higher sales of Syfovre (pegcetaco ...

Financial Data and Key Metrics Changes - Total revenue for Q4 2023 was $146 million, with full-year revenue reaching $397 million [24] - SYFOVRE generated $114 million in Q4 and $275 million for the full year, while EMPAVELI contributed $24 million in Q4 and $91 million for the full year [24][25] - The company reported a net loss of $89 million for Q4 and $529 million for the full year [25] Business Line Data and Key Metrics Changes - SYFOVRE has distributed over 200,000 doses since its launch, with approximately 215,000 injections administered [6][7] - EMPAVELI's compliance rates remain high at 97%, with 10% of demand in 2023 coming from treatment-naive patients [16] - The EMPAVELI Injector was launched in Q4 2023, receiving positive feedback and adoption [9] Market Data and Key Metrics Changes - SYFOVRE holds a market share of approximately 90% in the GA treatment market [14][16] - The company is facing increased competition in the PNH market due to the recent approval of an oral product [16] Company Strategy and Development Direction - The company aims to maximize access to SYFOVRE in the U.S. and expand its availability for GA patients worldwide [7][29] - Plans for 2024 include focusing on EMPAVELI's market position in PNH and advancing early-stage R&D programs, including the siRNA program APL-3007 [10][29] - The company is committed to addressing unmet patient needs and enhancing shareholder value [11][29] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the continued growth of SYFOVRE despite challenges faced in 2023 [5] - The company is optimistic about the re-examination of SYFOVRE's application in the EU, although it acknowledges the uphill battle ahead [8][9] - Management highlighted the importance of physician and patient support in the EU re-examination process [32] Other Important Information - The company expects total operating expenses in 2024 to be less than those in 2023 due to ongoing efficiencies from restructuring [26] - As of December 31, 2023, the company had $351 million in cash and cash equivalents, which is expected to fund projected operating expenses and capital expenditures for the foreseeable future [27][28] Q&A Session Summary Question: Impact of physician enthusiasm on EU reexamination - Management noted that letters of support from physicians and patient groups are important but uncertain in their impact on the reexamination process [32] Question: Growth expectations for Q1 relative to Q4 - Management indicated that despite seasonality impacts, they expect robust growth in March following January and February's strong performance [33] Question: Financial runway and capital flexibility - Management expressed confidence in their financial position with the capped call and cash reserves, allowing for flexibility without immediate capital raises [37] Question: GA population size estimation - Management explained that increased interactions with physicians revealed a larger GA patient population than previously estimated [44][46] Question: Details on the EU application revision - Management stated that the revision focused on educating about geographic atrophy and included new analyses to support their case [50][51] Question: SYFOVRE market share attribution - Management attributed the 90% market share to strong execution, transparency with the retina community, and the drug's efficacy profile [76]

Apellis Pharmaceuticals, Inc. (APLS) reported $146.38 million in revenue for the quarter ended December 2023, representing a year-over-year increase of 546%. EPS of -$0.73 for the same period compares to -$1.50 a year ago.The reported revenue compares to the Zacks Consensus Estimate of $146.43 million, representing a surprise of -0.03%. The company delivered an EPS surprise of -10.61%, with the consensus EPS estimate being -$0.66.While investors closely watch year-over-year changes in headline numbers -- re ...