Hey there! I'm a biotech and healthcare investment analyst with several years of bedside clinical experience and a Master of Business Administration. I utilize risk-return charts and DCF analyses to highlight investment opportunities and risks. I'm a big fan of the barbell strategy: 90% in safe assets like Treasuries and ETFs, and 10% in high-growth stocks—keeping risk management front and center. Since markets are pretty efficient and returns can be random, I draw inspiration from 'Superforecasting' and 'A ...

Thank you for reading my research on Seeking Alpha. If you want to learn even more about my method and how I discover these investment opportunities, please check out my subscription marketplace service, Compounding Healthcare , and sign up for a free trial.It has been almost a year since my previous Apellis Pharmaceuticals, Inc. (NASDAQ: APLS ) article , where I discussed the company's C3 inhibitor technology, as well as the prospects for their flagship treatment, pegcetacoplan. Despite my trepidation abou ...

Apellis Pharmaceuticals (APLS) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has confirmed its June 2024 negative opinion on the regulatory filing for intravitreal pegcetacoplan to treat geographic atrophy (GA) secondary to age-related macular degeneration (AMD). Shares of the company lost 11.5% on Friday in response.Management expressed deep disappointment in the outcome, stating that millions of GA patients in the EU remain without treatmen ...

WALTHAM, Mass., Sept. 20, 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 confirmed its June 2024 negative opinion on the marketing authorization application of intravitreal pegcetacoplan for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration. “We are deeply disappointed by this outcome, which leaves millions of Europeans with GA ...

Met the primary endpoint, achieving statistically significant 68% (p<0.0001) reduction in proteinuria compared to placebo in a broad study population Positive results consistent across all subgroups, including C3G and IC-MPGN, adolescent and adult patients, and native and post-transplant kidneys Demonstrated favourable safety, consistent with established profile Companies plan to submit data for regulatory approval in the US and EU STOCKHOLM, Aug. 8, 2024 /PRNewswire/ -- Sobi® (STO: SOBI) and Apellis Pha ...

Met the primary endpoint, achieving statistically significant 68% (p<0.0001) reduction in proteinuria compared to placebo in a broad study populationPositive results consistent across all subgroups, including C3G and IC-MPGN, adolescent and adult patients, and native and post-transplant kidneysDemonstrated favourable safety, consistent with established profileCompanies plan to submit data for regulatory approval in the US and EU STOCKHOLM, Aug. 8, 2024 /PRNewswire/ -- Sobi® (STO: SOBI) and Apellis Pharmaceu ...

财务数据和关键指标变化 - 第二季度总收入约为2亿美元,其中SYFOVRE产品收入为1.55亿美元,EMPAVELI产品收入为2450万美元,相比2023年第二季度的9500万美元总收入有大幅增长 [47] - 销售成本为2300万美元,研发费用为7800万美元,销售及管理费用为1.28亿美元,净亏损为3800万美元 [48] - 公司正在采取措施加强资产负债表,通过与Sixth Street的非稀释性再融资交易,获得了多达4.75亿美元的资金,大幅改善了公司的流动性和灵活性 [49][50][51][52][53][54] SYFOVRE业务数据和关键指标变化 - SYFOVRE第二季度收入为1.55亿美元,环比增长超过12%,这在产品上市第二年仍保持高增长率,是长期需求强劲的良好指标 [24] - 公司在第二季度交付了超过79,000支商业用量和约5,000支样品,需求持续加速,6月份是自推出以来最高需求月 [24] - SYFOVRE在GA治疗市场的份额约为75%,公司相信其领导地位将得以维持,并将继续推动整个GA市场的增长 [27][28] - 公司正在执行分两个阶段的商业和医学策略,第一阶段专注于透明化和教育,第二阶段则专注于巩固在这个不断增长市场的领导地位 [29][30] - 公司已与两家大型连锁药房福利管理公司达成协议,将SYFOVRE定为首选产品,这显示了其在临床和经济价值方面的优势 [33][34][35] EMPAVELI业务数据和关键指标变化 - EMPAVELI第二季度收入为2450万美元,患者依从性保持在97%的高水平 [38] - 公司正在探索将EMPAVELI拓展到新适应症,如C3G和IC-MPGN,预计本月将公布VALIANT III期试验的结果 [19][43][44][45] 公司战略和发展方向 - 公司目前拥有两款潜在的重磅药物SYFOVRE和EMPAVELI,正在为患者带来重大改变 [8] - 公司正专注于确保每一个需要治疗的GA患者都能获得SYFOVRE,并将其发展成为一款数十亿美元的重磅药物 [16] - 公司正在推进多个早期开发项目,利用其在补体科学方面的核心专长来推动下一阶段的价值创造 [20] - 公司现已具备清晰的现金流正向目标,无需依赖资本市场即可进行未来的投资和增长 [21][22] 行业竞争 - SYFOVRE在GA治疗市场保持领导地位,约占75%的市场份额,公司相信其领导地位将得以维持,主要基于其差异化的疗效优势和灵活的给药方案 [27][28] - 尽管竞争对手最近获得新的J编码而获得一些有利因素,但公司仍维持了约50%的新患者份额,并相信长期市场格局将有利于SYFOVRE [25][26] - 公司采取了谨慎的定价策略,不会过度折扣,因为这可能导致长期价格下降,而是专注于强化SYFOVRE的疗效优势和灵活给药方案 [25][31] 管理层对经营环境和未来前景的评论 - 公司对SYFOVRE在GA市场的长期领导地位充满信心,认为其差异化的疗效优势和灵活的给药方案将是关键驱动因素 [9][13][14][15][16] - 公司对EMPAVELI在新适应症如C3G和IC-MPGN的拓展前景感到乐观,认为这将是一个约3倍于PNH市场的新机会 [19][39] - 公司对欧洲SYFOVRE审批前景保持谨慎乐观,认为有望在2024年第四季度获得最终决定 [17][18] - 公司有信心未来将实现现金流正向,无需依赖资本市场即可支持业务增长 [21][22][54] 其他重要信息 - 公司在ASRS会议上有5个口头报告,包括一个关于视觉功能的最新数据,这是首次获批GA治疗在预设终点显示视觉功能获益 [40][41] - 公司与Sixth Street达成的非稀释性再融资交易,为公司提供了高达4.75亿美元的资金支持,大幅改善了公司的财务状况和灵活性 [49][50][51][52][53] 问答环节重要的提问和回答 问题1 **Jonathan Miller 提问** 询问新患者份额是否会随着ASRS会议的成功而再次提升,以及公司实现现金流正向的预测是否假设了超过现有新患者份额的增长 [57][58][61] **Cedric Francois 和 Adam Townsend 回答** - 公司有信心通过强调SYFOVRE的疗效优势和灵活给药方案,重新占领新患者份额的领先地位 [58][59][60] - 公司实现现金流正向的预测并不需要假设新患者份额的进一步提升,主要依赖于现有的市场份额和收入增长 [61] 问题2 **Anupam Rama 提问** 询问第二季度各月SYFOVRE销售情况,是否存在竞争对手J编码影响的动态变化 [67] **Adam Townsend 回答** - 6月份是自推出以来SYFOVRE单月最高需求,公司在第二季度各月均保持了强劲的双位数增长 [68][69] - 尽管竞争对手获得J编码带来一些有利因素,但公司仍维持了约50%的新患者份额,显示SYFOVRE的长期竞争优势 [69] 问题3 **Yigal Nochomovitz 提问** 询问公司在C3G和IC-MPGN适应症上的定位策略,以及需要在哪些二级终点上取得积极结果 [78][79] **Cedric Francois 回答** - 公司将VALIANT III期试验纳入C3G和IC-MPGN两个适应症,希望能够获得足够的数据支

Apellis Pharmaceuticals, Inc. (APLS) incurred second-quarter 2024 loss of 28 cents per share (excluding loss on extinguishment of development liability), narrower than the Zacks Consensus Estimate of a loss of 33 cents. The company had incurred a loss of $1.02 per share in the year-ago quarter.Total revenues amounted to $199.7 million in the reported quarter, beating the Zacks Consensus Estimate of $189.5 million. In the year-ago quarter, the company had reported revenues of $95 million.The top line skyrock ...

For the quarter ended June 2024, Apellis Pharmaceuticals, Inc. (APLS) reported revenue of $199.69 million, up 110.3% over the same period last year. EPS came in at -$0.28, compared to -$1.02 in the year-ago quarter.The reported revenue represents a surprise of +5.39% over the Zacks Consensus Estimate of $189.47 million. With the consensus EPS estimate being -$0.33, the EPS surprise was +15.15%.While investors scrutinize revenue and earnings changes year-over-year and how they compare with Wall Street expect ...

Apellis Pharmaceuticals, Inc. (APLS) came out with a quarterly loss of $0.28 per share versus the Zacks Consensus Estimate of a loss of $0.33. This compares to loss of $1.02 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 15.15%. A quarter ago, it was expected that this company would post a loss of $0.54 per share when it actually produced a loss of $0.54, delivering no surprise.Over the last four quarters, the company has sur ...