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.
週二，Harmony Biosciences（納斯達克股票代碼：HRMY）宣佈收購Epygenix Therapeutics，在其擴大的中樞神經系統（CNS）後期資產管道中增加了一家罕見的癲癇特許經營權。
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.
根據最終協議的條款，Harmony支付了3500萬美元的現金，根據發展和監管里程碑，可能支付高達1.3億美元的款項。
In addition, there are potential payments of up to $515 million if certain sales milestones are achieved.
此外，如果實現某些銷售里程碑，則可能支付高達5.15億美元的款項。
"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總裁兼首席執行官傑弗裏·戴諾醫學博士表示：“收購Epygenix爲我們提供了三個處於後期開發階段的不同CNS特許經營權，每個特許經營權在美國的潛在峯值銷售機會爲10億至20億美元。”
"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..."
“我們一直在戰略性地建立一個強大而多元化的罕見疾病創新中樞神經系統資產管道，這改變了我們的業務。此次收購建立在我們在睡眠/覺醒領域的領導地位以及我們在神經行爲障礙方面的特許經營權的基礎上...”
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.
此次收購包括鹽酸克萊米唑（EPX-100），一種有效的口服、中樞作用的血清素（5HT2）激動劑。它目前正在進行一項針對兒童和成人的德拉維特綜合徵的關鍵註冊臨床試驗，並準備進入倫諾克斯-加斯陶特綜合徵的第三階段。
A second investigational product, EPX-200, is a potent, oral, centrally active , and selective 5HT2C agonist and is currently in IND-enabling studies.
第二種研究產品 EPX-200 是一種強效、口服、中樞活性和選擇性的 5HT2C 激動劑，目前正處於支持臨床試驗的研究中。
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報告稱，第一季度調整後的每股收益爲0.88美元，高於去年同期的0.66美元，超過了市場預期的0.62美元。
The company reported sales of $154.6 million, missing the consensus of $154.8 million.
該公司報告的銷售額爲1.546億美元，未達到1.548億美元的共識。
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).
與2023年同期相比增長30％，主要歸因於WAKIX的強勁商業銷售，這得益於持續的有機需求挖掘了巨大的市場機會（美國約有80,000名發作性睡病患者）。
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的平均患者人數連續增加了約150名患者，達到約6,300人。
Guidance: Harmony reiterates fiscal year 2024 net product revenue of $700 million to $720 million versus consensus of $710.8 million.
指導方針：Harmony重申2024財年的淨產品收入爲7億美元至7.2億美元，而市場共識爲7.108億美元。
Price Action: HRMY shares are up 9.79% at $32.11 at the last check Tuesday.
價格走勢：在週二的最後一次檢查中，HRMY股價上漲9.79％，至32.11美元。