Harmony Biosciences Expands It CNS-Focused Pipeline With Epilepsy Candidate, Q1 Earnings Beat Street View
Harmony Biosciences Expands It CNS-Focused Pipeline With Epilepsy Candidate, Q1 Earnings Beat Street View
Tuesday, Harmony Biosciences (NASDAQ:HRMY) announced the acquisition of Epygenix Therapeutics, adding a rare epilepsy franchise to its expanding late-stage pipeline of central nervous system (CNS) assets.
周二，Harmony Biosciences（纳斯达克股票代码：HRMY）宣布收购Epygenix Therapeutics，在其扩大的中枢神经系统（CNS）后期资产管道中增加了一家罕见的癫痫特许经营权。
Under the terms of the definitive agreement, Harmony paid $35 million in cash with the potential for payments of up to $130 million based on development and regulatory milestones.
根据最终协议的条款，Harmony支付了3500万美元的现金，根据发展和监管里程碑，可能支付高达1.3亿美元的款项。
In addition, there are potential payments of up to $515 million if certain sales milestones are achieved.
此外，如果实现某些销售里程碑，则可能支付高达5.15亿美元的款项。
"The acquisition of Epygenix gives us three distinct CNS franchises in late-stage development, each with a potential US peak sales opportunity of $1B-$2B," said Jeffrey M. Dayno, M.D., President and Chief Executive Officer at Harmony Biosciences.
Harmony Biosciences总裁兼首席执行官杰弗里·戴诺医学博士表示：“收购Epygenix为我们提供了三个处于后期开发阶段的不同CNS特许经营权，每个特许经营权在美国的潜在峰值销售机会为10亿至20亿美元。”
"We have been strategically building a robust and diverse pipeline of innovative CNS assets for rare diseases that has transformed our business. This acquisition builds on our leadership position in sleep/wake and our franchise in neurobehavioral disorders..."
“我们一直在战略性地建立一个强大而多元化的罕见疾病创新中枢神经系统资产管道，这改变了我们的业务。此次收购建立在我们在睡眠/觉醒领域的领导地位以及我们在神经行为障碍方面的特许经营权的基础上...”
The acquisition includes clemizole hydrochloride (EPX-100), a potent, oral, centrally acting serotonin (5HT2) agonist. It is currently in a pivotal registrational clinical trial for Dravet syndrome in children and adults and is poised to enter Phase 3 for Lennox-Gastaut syndrome.
此次收购包括盐酸克莱米唑（EPX-100），一种有效的口服、中枢作用的血清素（5HT2）激动剂。它目前正在进行一项针对儿童和成人的德拉维特综合征的关键注册临床试验，并准备进入伦诺克斯-加斯陶特综合征的第三阶段。
A second investigational product, EPX-200, is a potent, oral, centrally active , and selective 5HT2C agonist and is currently in IND-enabling studies.
第二种研究产品 EPX-200 是一种强效、口服、中枢活性和选择性的 5HT2C 激动剂，目前正处于支持临床试验的研究中。
Harmony Biosciences reported that the first quarter adjusted EPS of $0.88, up from $0.66 a year ago, beat the consensus of $0.62.
Harmony Biosciences报告称，第一季度调整后的每股收益为0.88美元，高于去年同期的0.66美元，超过了市场预期的0.62美元。
The company reported sales of $154.6 million, missing the consensus of $154.8 million.
该公司报告的销售额为1.546亿美元，未达到1.548亿美元的共识。
The 30% growth versus the same period in 2023 is primarily attributed to strong commercial sales of WAKIX driven by continued organic demand tapping into a large market opportunity (approximately 80,000 patients diagnosed with narcolepsy in the US).
与2023年同期相比增长30％，主要归因于WAKIX的强劲商业销售，这得益于持续的有机需求挖掘了巨大的市场机会（美国约有80,000名发作性睡病患者）。
The average number of patients on WAKIX increased by approximately 150 patients sequentially to approximately 6,300 for the quarter ended March 31, 2024.
截至2024年3月31日的季度，WAKIX的平均患者人数连续增加了约150名患者，达到约6,300人。
Guidance: Harmony reiterates fiscal year 2024 net product revenue of $700 million to $720 million versus consensus of $710.8 million.
指导方针：Harmony重申2024财年的净产品收入为7亿美元至7.2亿美元，而市场共识为7.108亿美元。
Price Action: HRMY shares are up 9.79% at $32.11 at the last check Tuesday.
价格走势：在周二的最后一次检查中，HRMY股价上涨9.79％，至32.11美元。