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 ...

EMA审查安排 - 欧洲药品管理局（EMA）重新安排了对Apellis公司眼底黄斑变性治疗药物的审查，预计最迟在2024年7月前做出委员会药品评估委员会（CHMP）的意见[1] 欧洲法院裁决 - 欧洲法院于2024年3月14日就EMA专家组织进行了裁决，对EMA的专家组织政策产生了影响[2] Apellis与EMA合作 - EMA的决定是对欧洲法院裁决的程序性回应，与pegcetacoplan数据包无关，Apellis将继续与EMA密切合作审查pegcetacoplan的营销申请[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 ...

财务数据和关键指标变化 - 2023年第四季度SYFOVRE美国净产品收入为1.14亿美元,全年收入为2.75亿美元 [13][44] - 2023年第四季度EMPAVELI美国净产品收入为2400万美元,全年收入为9100万美元 [18][44] - 2023年全年总收入为3.97亿美元 [43] - 2023年全年净亏损为5.29亿美元 [45] 各条业务线数据和关键指标变化 - SYFOVRE自上市以来已分发超过20万剂,预计已有约21.5万剂注射给患者 [11] - SYFOVRE发生视网膜血管炎的风险率约为0.01% [12] - EMPAVELI注射器获批并推出,反馈和采用情况良好 [18] 各个市场数据和关键指标变化 - 公司预计GA患者人数可能高达150万,而之前估计为100万 [25] - SYFOVRE在GA治疗中的市场份额约为90% [25] - EMPAVELI在PNH市场中约10%的需求来自治疗naive患者,依从性高达97% [27] 公司战略和发展方向及行业竞争 - 公司将继续专注于扩大SYFOVRE在美国的患者覆盖,并努力将其带到全球市场 [14] - 公司将继续专注于最大化EMPAVELI在PNH市场的地位,并期待在C3G和IC-MPGN适应症的III期试验数据 [19] - 公司将继续推进早期管线,包括siRNA项目APL-3007和与Beam的基因编辑项目 [20] - 公司将面临EMPAVELI在PNH市场的竞争,但相信EMPAVELI注射器可以提升竞争力 [28][29] 管理层对经营环境和未来前景的评论 - 公司对SYFOVRE在欧洲的重新审查持谨慎乐观态度,但认为这将是一场艰难的战斗 [15][16][17] - 公司对SYFOVRE在美国的持续增长和EMPAVELI在PNH市场的表现感到鼓舞 [8][9][18] - 公司对2024年的执行和实现愿景充满信心 [10] 问答环节重要的提问和回答 问题1 **Jon Miller 提问** 询问公司对欧洲重新审查SYFOVRE申请的信心,以及之前申请失败的原因 [59][60] **Cedric Francois 回答** 公司获得来自欧洲医疗界的大量支持信函,但认为重新审查仍将是一场艰难的战斗,之前失败的原因尚不清楚 [60][61] 问题2 **Tazeen Ahmad 提问** 询问公司对APL-3007 siRNA项目的预期和潜在适应症 [75][76] **Cedric Francois 回答** 公司正在进行健康受试者的剂量递增研究,希望了解C3的降低程度和持续时间,具体适应症暂时保密,但公司对管线前景感到兴奋 [76] 问题3 **Yigal Nochomovitz 提问** 询问公司是否考虑使用视网膜电图(ERG)等其他功能性指标来支持SYFOVRE的疗效 [90][91] **Cedric Francois 和 Caroline Baumal 回答** ERG不适合用于地理性青光眼,公司已有强大的微视野图数据支持SYFOVRE的功能性获益,这些数据更能说明问题 [91][92][93][94][95]

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 ...