WAKIX® (pitolisant) Net Revenue of $154.6 Million for First Quarter 2024; ~30% Growth Year-over-Year Supplemental New Drug Application for Pitolisant in Idiopathic Hypersomnia Planned for Second Half 2024 On Track Toward Pediatric Exclusivity to Extend WAKIX Exclusivity to September 2030: Pediatric Narcolepsy sNDA PDUFA Date of June 21, 2024; PWS Phase 3 TEMPO Study Initiated in March 2024 Pitolisant Franchise Revenue Potential Extended Beyond 2040 With Next-Generation Formulations; Reports Positive Pharmac ...

Harmony Biosciences Holdings, Inc.调查 - Wolf Popper LLP正在调查Harmony Biosciences Holdings, Inc.（"Harmony"）普通股（NASDAQ:HRMY）的潜在证券欺诈索赔[1] - Scorpion Capital发布了一份短卖报告，指控Harmony的WAKIX药物存在严重风险，FDA收到了大量严重不良事件报告[3] - Harmony的股价在短卖报告发布后下跌25.8%[3] - Wolf Popper已经成功为被欺诈投资者追回了数十亿美元[5]

PLYMOUTH MEETING, Pa., April 16, 2024 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) today announced that it will report first quarter 2024 financial results on Tuesday, April 30, 2024, before the open of the U.S. financial markets. Harmony will host a conference call and live webcast on April 30, 2024, at 8:30 a.m. ET to discuss the results. To participate in the call, please dial (800) 579-2543 (domestic) or +1 (785) 424-1789 (international), and reference passcode HRMYQ124. It is recom ...

Harmony Biosciences与Bioprojet签署独家许可协议 - TPM-1116代表了一种新的化学系列的OX2R激动剂，具有潜力成为最佳临床配置文件[1] - Harmony Biosciences将向Bioprojet支付2505万美元的前期许可费，以获得在美国和拉丁美洲领土独家开发、生产和商业化TPM-1116的权利[1] 开发、生产和商业化TPM-1116 - Harmony将根据开发和监管里程碑的实现支付高达1.275亿美元的费用，并根据销售里程碑的实现支付高达2.4亿美元的费用[1] - Harmony将在授权领土的产品销售中支付中等百分比的版税率[1]

Harmony Biosciences Holdings, Inc. (NASDAQ:HRMY) Q4 2023 Results Conference Call February 22, 2024 8:30 AM ET Company Participants Luis Sanay - Head of Investor Relations Jeffrey Dayno - President and CEO Jeffrey Dierks - Chief Commercial Officer Kumar Budur - Chief Medical Officer Sandip Kapadia - Chief Financial Officer and Chief Administrative Officer Conference Call Participants Ami Fadia - Needham & Company Charles Duncan - Cantor Fitzgerald Francois Brisebois - Oppenheimer David Amsellem - Piper Sandl ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES AND EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-39450 HARMONY BIOSCIENCES HOLDINGS, INC. (Exact name of registrant as specified in its charter) Delaware 82-2279923 (State or ot ...

业绩总结 - Harmony Biosciences Holdings, Inc.在Q3 23实现了WAKIX净收入达到1.603亿美元，同比增长37%[4] - Harmony Biosciences Holdings, Inc.在Q3 23的净产品收入为1.603亿美元，同比增长37%[12] - Harmony Biosciences Holdings, Inc.在Q3 23的GAAP净收入为3.85亿美元，同比下降46%[12] 用户数据 - Harmony Biosciences Holdings, Inc.在Q3 23平均患者数量约为5,800人，继续保持强劲增长[4] 财务状况 - Harmony Biosciences Holdings, Inc.在Q3 23实现了强劲的财务状况，现金余额达到4.384亿美元[4] - Harmony Biosciences Holdings, Inc.在Q3 23的现金、现金等价物和投资证券达到4.384亿美元[11] 运营费用 - Harmony Biosciences Holdings, Inc.在Q3 23的总运营费用为6.35亿美元，同比下降23%[12] 调整后净收入 - Harmony Biosciences Holdings, Inc.在Q3 23的非GAAP调整后净收入为5.81亿美元[13] - Harmony Biosciences Holdings, Inc.在Q3 23的非GAAP调整后净收入为5.88亿美元，每股摊薄净收入为0.97美元[13]

财务数据和关键指标变化 - 第三季度公司实现净收入160.3百万美元,同比增长37% [11][49] - 公司毛利率和经营利润率均有大幅提升 [50] - 公司第三季度非GAAP调整后净收益为58.8百万美元,每股0.97美元 [51] - 公司第三季度经营活动产生现金流63百万美元,现金余额438.4百万美元 [52] 各条业务线数据和关键指标变化 - Wakix产品第三季度净销售额为160.3百万美元,同比增长37% [11][25] - Wakix平均患者人数增加至约5,800人,环比增加约350人 [26][27] - Wakix处方医生数量和处方深度持续扩大,渗透率提升 [28][29][31] 各个市场数据和关键指标变化 - 公司在未参与阿片类药物REMS计划的医生群体中的Wakix渗透率持续提升 [77][80] 公司战略和发展方向及行业竞争 - 公司正在积极推进Wakix的适应症扩展,包括特发性嗜睡症(IH)和其他神经系统疾病 [13][14][37][38] - 公司与合作伙伴正在开发新的Wakix制剂,以延长专利期至2040年 [16][41][42] - 公司通过收购Zynerba公司,拓展了神经精神类罕见疾病的管线 [17][18][43][45] - 公司将继续通过业务开发活动,扩大管线和产品组合 [19][20] 管理层对经营环境和未来前景的评论 - 公司对Wakix在成人narcolepsy适应症的市场潜力超过10亿美元充满信心 [11][25][55] - 公司有信心通过新适应症和新制剂,将Wakix的收入潜力进一步提升至20亿美元 [15][55] - 公司对未来业务发展前景保持乐观,将继续投资研发和商业化 [48][56] 问答环节重要的提问和回答 问题1 **Francois Brisebois 提问** 询问新制剂对公司专利期的影响 [66][67] **Kumar Budur 回答** 公司正在开发两种新的Wakix制剂,一种用于延长专利期至2040年,另一种为快速上市的短期策略 [71][72] 问题2 **David Amsellem 提问** 询问公司在特发性嗜睡症(IH)适应症上的策略 [99][100] **Jeffrey Dayno 和 Kumar Budur 回答** 公司将基于INTUNE试验的总体证据,与FDA积极沟通,争取获得IH适应症批准 [101][105][107][108] 问题3 **Corinne Jenkins 提问** 询问新制剂2的开发计划和商业化策略 [142][143][144][145][146] **Kumar Budur 和 Jeffrey Dierks 回答** 新制剂2将采用快速上市的简化开发计划,不会采取替代Wakix的策略,而是提供另一个差异化的治疗选择 [143][144]

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 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 September 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-39450 HARMONY BIOSCIENCES HOLDINGS, INC. (Exact name of registrant as specified in its charter) Delaware ...

Q2 2023 Financial and Business Update August 1, 2023 Forward-Looking Statements ...