WALTHAM, Mass., June 28, 2024 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a negative opinion on the marketing authorization application (MAA) of intravitreal pegcetacoplan for the treatment of geographic atrophy (GA). Notably, there were multiple dissenting votes by CHMP members to this opinion. Apellis plans to seek re-examination and expects a final opinion ...

Apellis Pharmaceuticals (APLS) announced positive data from the late-stage GALE long-term extension study evaluating its marketed drug, Syfovre (pegcetacoplan injection), to treat patients with geographic atrophy (GA) secondary to age-related macular degeneration.Per the data readout, presented at a recent medical conference, treatment with Syfovre in the GALE study preserved visual function at 36 months in the GA patients. Per Apellis, Syfovre is the only approved GA treatment to show a benefit on visual f ...

SYFOVRE is the only approved GA treatment to demonstrate a visual function benefit in a prespecified endpointData presented at the Clinical Trials at the Summit Meeting WALTHAM, Mass., June 10, 2024 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (NASDAQ:APLS) today announced that SYFOVRE® (pegcetacoplan injection) preserved visual function at 36 months in patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). These positive data from the GALE long-term extension study ...

It has been about a month since the last earnings report for Apellis Pharmaceuticals, Inc. (APLS) . Shares have lost about 1.9% in that time frame, underperforming the S&P 500.Will the recent negative trend continue leading up to its next earnings release, or is Apellis Pharmaceuticals due for a breakout? Before we dive into how investors and analysts have reacted as of late, let's take a quick look at its most recent earnings report in order to get a better handle on the important catalysts. Apellis’ Q1 Ea ...

Apellis Pharmaceuticals (APLS) , in collaboration with Sobi, reported positive one-year results from the mid-stage study evaluating systemic pegcetacoplan to treat post-transplant recurrence of C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN).Pegcetacoplan is being developed as a targeted C3 therapy that addresses the cause of these rare and debilitating kidney diseases.Per the data readout, seven patients in the phase II NOBLE study, representing 64% of ...

Rapid reduction in disease activity seen at 12 weeks was sustained at one year 55% of patients showed zero C3c staining intensity, indicating that C3c deposits were clearedHighlighted as late-breaking oral presentation at the European Renal Association (ERA) Congress WALTHAM, Mass. and STOCKHOLM, Sweden, May 24, 2024 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (NASDAQ:APLS) and Sobi® (STO:SOBI) today announced positive one-year results from the Phase 2 NOBLE study investigating systemic pegcetacoplan, ...

Rapid reduction in disease activity seen at 12 weeks was sustained at one year 55% of patients showed zero C3c staining intensity, indicating that C3c deposits were clearedHighlighted as late-breaking oral presentation at the European Renal Association (ERA) Congress WALTHAM, Mass. and STOCKHOLM, Sweden, May 24, 2024 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) and Sobi® (STO:SOBI) today announced positive one-year results from the Phase 2 NOBLE study investigating systemic pegcetacoplan ...

业绩总结 - Apellis的EMPARELI美国净产品销售额为25.6亿美元[15] - Apellis的SYFOVRE美国净产品销售额为137.5亿美元，较上季度增长20%[5] - Apellis预计其现金和预期产品收入将足以支持未来可预见的运营支出和资本支出[15]

财务数据和关键指标变化 - 第一季度总收入为1.723亿美元,包括SYFOVRE 1.375亿美元和EMPAVELI 2,560万美元的净产品收入,相比2023年第一季度的4,480万美元有大幅增长 [50] - 成本销售为2,020万美元,研发费用为8,470万美元,销售及一般管理费用为1.295亿美元,净亏损为6,640万美元 [51][52] - 公司预计2024年全年的总运营费用将低于2023年 [52] - 截至3月31日,公司现金及现金等价物为3.26亿美元,有足够的现金来支持未来可预见的运营 [53] 各条业务线数据和关键指标变化 SYFOVRE - 第一季度SYFOVRE销售额为1.375亿美元,较第四季度增长20% [7][22] - 截至3月,已有25万例SYFOVRE注射,首12个月销售超4亿美元,大幅超出公司和华尔街的预期 [9][10] - SYFOVRE在市场上的领导地位得益于三大因素:1)治疗效果随时间持续增强,第三年可减缓42%的地理性萎缩进展;2)安全性良好;3)灵活的给药方案 [9][10] - 公司预计SYFOVRE有潜力成为美国市场上数十亿美元级别的产品 [8] EMPAVELI - 第一季度EMPAVELI销售额为2,560万美元 [7] - 患者依从性极高,达97%,安全性也很好,3年来未出现一例脑膜炎感染,血栓发生率也很低 [32] - 但面临新竞争对手进入市场,预计未来6-12个月内EMPAVELI销售会受到一定压力,需要强调其长期疗效和安全性来吸引医生和患者 [32][33] - 公司计划将EMPAVELI拓展至C3G和原发性IC-MPGN两种罕见肾脏疾病,这些疾病的患者群体是PNH的3倍,如获批将能利用现有销售团队推广 [14][35] 各个市场数据和关键指标变化 - 公司正在努力将SYFOVRE推广到全球市场,最近欧洲药品管理局将SYFOVRE申请重置回审评的最后阶段,预计最迟7月将有CHMP意见 [11][12] 公司战略和发展方向及行业竞争 - 公司现已拥有两款获批产品,战略、运营和财务实力都很强,能为股东带来长期价值 [8] - SYFOVRE是公司交付长期价值的关键,公司有信心其能成为数十亿美元级别的产品 [8][10] - 公司正在努力将EMPAVELI拓展至C3G和IC-MPGN等其他适应症,这些疾病的患者群体是PNH的3倍,如获批将能利用现有销售团队推广 [14][35][38][39][40][41][42][43][44][45][46] - 公司认为竞争对手的进入有利于整个市场的发展,自身产品的强大疗效和安全性数据将有利于在竞争中脱颖而出 [87][88][89] 管理层对经营环境和未来前景的评论 - 2024年开局强劲,SYFOVRE和EMPAVELI销售均保持良好增长 [7][13] - SYFOVRE的强劲表现证明了其在GA治疗中的领导地位,公司有信心其能成为数十亿美元级别的产品 [8][10] - EMPAVELI在PNH治疗中已成为标准疗法,未来有望进一步拓展至C3G和IC-MPGN等其他适应症 [13][14][15][16][17] - 公司有信心未来能够开发出更多能为患者带来生命改变的创新药物 [18] 问答环节重要的提问和回答 问题1 **Jonathan Miller 提问** 询问公司SYFOVRE在GA市场的份额与竞争对手Izervay的市场份额情况 [57][58][59][60][61][62][63] **Adam Townsend 回答** 公司根据患者使用数量计算市场份额,SYFOVRE目前占据约85%的市场份额,是GA治疗的首选。公司有信心SYFOVRE将保持市场领导地位,因其强大的疗效、良好的安全性和灵活的给药方案 [61][62][63] 问题2 **Tazeen Ahmad 提问** 询问SYFOVRE的增长率是否会出现放缓 [68][69] **Adam Townsend 回答** 第一季度SYFOVRE销售同比增长20%,这是非常强劲的增长。公司预计未来SYFOVRE的增长势头将保持良好 [72][73] 问题3 **Yigal Nochomovitz 提问** 询问公司是否有统计SYFOVRE使用患者总数的数据 [87][88][89][90][91] **Cedric Francois 和 Adam Townsend 回答** 公司没有披露具体的患者使用数据,但表示SYFOVRE是GA治疗的首选,新患者和现有患者的使用量都在持续增加。公司还表示,SYFOVRE的首次注射后出现的少数血管炎反应属于正常范围,医生已有足够的经验和信心继续使用 [91][92][93][94][95][96]

Apellis Pharmaceuticals, Inc. (APLS) incurred a first-quarter 2024 loss of 54 cents per share, which matched the Zacks Consensus Estimate. The company had incurred a loss of $1.56 per share in the year-ago quarter.Total revenues amounted to $172.3 million in the reported quarter, beating the Zacks Consensus Estimate of $160.5 million. In the year-ago quarter, the company had reported revenues of $44.8 million.The top line skyrocketed 284% year over year, owing to higher sales of Syfovre (pegcetacoplan injec ...