Amylyx Pharmaceuticals, Inc. (AMLX) came out with a quarterly loss of $0.46 per share versus the Zacks Consensus Estimate of $0.24. This compares to earnings of $0.02 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -291.67%. A quarter ago, it was expected that this company would post earnings of $0.20 per share when it actually produced earnings of $0.07, delivering a surprise of -65%.Over the last four quarters, the company h ...

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 peri ...

Exhibit 99.1 Amylyx Pharmaceuticals Reports First Quarter 2024 Financial Results ˗ Company plans to engage with FDA based on interim data from the Phase 2 HELIOS clinical trial demonstrating improvements in pancreatic function, glycemic control, and vision in participants with Wolfram syndrome treated with AMX0035; topline data from all 12 participants at Week 24 anticipated in fall of 2024 ˗ Interim analysis from the ORION study of AMX0035 in progressive supranuclear palsy continues to be expected in mid-2 ...

Amylyx Pharmaceuticals, Inc. (AMLX) announced that it will remove its amyotrophic lateral sclerosis (ALS) drug Relyvrio (sodium phenylbutyrate and taurursodiol, also known as AMX0035) from the U.S. markets and it has already started a process with the FDA on the same.The drug, approved under the brand name Albrioza in Canada, will also be removed from Canadian markets.While the formal decision to remove the drug from these markets has come recently, the company was contemplating the same following the failu ...

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) (“Amylyx” or the “Company”) today announced the addition of Bernhardt G. Zeiher, MD, FCCP, FACP, to its Board of Directors (“Board”). Dr. Zeiher brings more than 20 years of drug development experience where, in his various roles, he oversaw the approval of 15 new treatments that addressed people’s unmet needs in serious diseases with few to no treatment options. Most recently, he served as Chief Medical Officer (“CMO”) of Astell ...

Shares of Amylyx Pharmaceuticals (AMLX) nosedived 82.2% on Mar 8 after management announced topline results from the phase III PHOENIX study evaluating Relyvrio (AMX0035) for the treatment of amyotrophic lateral sclerosis (“ALS”). The study did not meet its primary or secondary endpoints.The PHOENIX study failed to achieve statistical significance in the primary endpoint of the Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R) total score following 48 weeks of treatment with Relyvrio. ...

AMX0035试验结果 - Amylyx制药公司宣布了PHOENIX试验的顶线结果，该试验未达到主要终点[1] - AMX0035在PHOENIX试验中未显示出统计学显著性[5] - AMX0035在PHOENIX试验中表现出良好的耐受性和安全性[6] AMX0035疾病研究 - AMX0035在预临床研究中显示出对神经退行性疾病具有潜在作用[8] - AMX0035正在进行其他神经退行性疾病的研究[30] 公司前瞻性声明 - 公司发布的新闻和财报中包含了前瞻性声明，提到了与监管机构的互动、RELYVRIO/ALBRIOZA在ALS患者中的持续可用性、暂停推广RELYVRIO/ALBRIOZA、如果RELYVRIO/ALBRIOZA从市场撤出将如何保证患者继续获得药物、公司自愿撤回RELYVRIO/ALBRIOZA的可能性、AMX0035在其他神经退行性疾病中的持续评估、ORION和HELIOS研究中预期数据披露的时间、以及AMX0035在Wolfram综合征中的生物活性证据[36] - 公司在新闻发布和电话会议中的前瞻性声明基于管理层对未来事件的当前预期，但存在许多风险和不确定性，可能导致实际结果与前瞻性声明中所述的结果有重大差异[36] - 公司承诺不会更新这些前瞻性声明，以反映它们发布后发生的事件或存在的情况[37]

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CAMBRIDGE, Mass.--(BUSINESS WIRE)--Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) today announced that it has granted stock options and restricted stock units (“RSUs”) to Linda Arsenault, the Company’s newly appointed Chief Human Resources Officer. The Compensation Committee of Amylyx’ Board of Directors approved the grant, effective February 20, 2024, to Ms. Arsenault of non-qualified stock option awards to purchase up to 101,400 shares of the Company’s common stock and 67,600 RSUs ...

财务数据和关键指标变化 - 2023年全年净产品收入为3.808亿美元 [13] - 2023年第四季度净产品收入为1.084亿美元,较第三季度的1.027亿美元有所增长,主要来自于国际市场收入的增加 [13] - 毛利率在9%左右,预计未来将在5%-10%之间 [15] - 研发费用和销售费用预计将稳步增长 [16][17] - 2023年实现了49.3百万美元的净利润,这是公司首次实现全年盈利 [18] 各条业务线数据和关键指标变化 - 美国市场仍占公司收入的绝大部分,第四季度美国收入略有增长 [13] - 加拿大和欧洲等国际市场收入增长较快,带动了第四季度整体收入的增长 [13] - 美国患者持续治疗率约为60%,加拿大为80%,公司正在采取措施提高美国患者的持续治疗率 [7][47] 各个市场数据和关键指标变化 - 美国市场仍是公司收入的主要来源,但国际市场收入增长较快 [13] - 公司正在与日本监管机构讨论监管路径,并在欧洲和以色列等国家启动了早期获取计划 [10] - 公司目标是将RELYVRIO推广到全球20多万名ALS患者 [10] 公司战略和发展方向及行业竞争 - 公司正在采取三大举措扩大RELYVRIO在美国的使用:1)加强与ALS专科医生的合作;2)提高普通神经科医生对RELYVRIO的认知;3)教育患者持续治疗的重要性 [8] - 公司正在加快ALS诊断的速度,开发新的生物标志物板用于更早诊断ALS [30] - 公司正在推进RELYVRIO在其他神经退行性疾病如进行性核上性麻痹(PSP)和沃尔夫朗综合征的开发 [26][27] - 公司认为RELYVRIO是ALS治疗的一个重要转折点,是首个在同一临床试验中显示可以延缓疾病进展、维持功能独立性和延长生存期的治疗 [10][24] 管理层对经营环境和未来前景的评论 - 公司对PHOENIX试验结果持乐观态度,认为如果结果支持RELYVRIO,将有助于进一步推广 [29] - 公司认为有望在2024年第二季度或之前公布PHOENIX试验的顶线数据 [9] - 公司表示如PHOENIX结果支持,将重新与全球监管机构接触,尽快获得更广泛的批准 [29] - 公司认为有望通过PHOENIX试验成为ALS治疗领域首个在两个不同试验中显示疗效的药物 [25] 问答环节重要的提问和回答 问题1 **Charlie Young 提问** 询问公司今年Part D改革对毛利的影响以及第四季度净患者数变化情况 [35] **Josh Cohen 和 Justin Klee 回答** Part D改革对公司影响有限,因为公司已有健全的患者援助计划;第四季度净患者数与第三季度持平 [36][37] 问题2 **Neena Bitritto-Garg 提问** 询问公司美国市场毛利率变动原因以及国际市场收入占比和未来趋势 [39] **Jim Frates 回答** 美国市场毛利率变动较小,国际市场收入增长较快,占比上升,未来将是公司的重要增长点 [43] 问题3 **Graig Suvannavejh 提问** 询问2024年初公司商业策略执行情况以及ALS生物标志物开发进展 [57] **Justin Klee 和 Josh Cohen 回答** 公司新商业策略反响良好,正在加强对ALS专科医生和普通神经科医生的教育;ALS生物标志物开发进展良好,将在今年公布初步结果 [58][60]