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 ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) HARMONY BIOSCIENCES HOLDINGS, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of (I.R.S. Employer incorporation or organization) Identification No.) Delaware 82-2279923 630 W. Germantown Pike, Suite 215, Plymouth Meeting, PA 19462 (Address of principal executive offices) (Zip Code) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES AND EXCHANG ...

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) (State or ...

Q2 2023 Financial and Business Update This presentation includes forward‐looking statements within the meaning of the Private Securities Reform Act of 1995. All statements other than statements of historical facts contained in these materials or elsewhere, including statements regarding Harmony Biosciences Holdings, Inc.'s (the "Company") future financial position, business strategy and plans and objectives of management for future operations, should be considered forward-looking statements. Forward-looking ...

Harmony Biosciences Holdings, Inc. (NASDAQ:HRMY) Q2 2023 Earnings Conference Call August 1, 2023 8:30 AM ET Company Participants Luis Sanay - Head, Investor Relations Dr. Jeffrey Dayno - President and CEO Jeffrey Dierks - Chief Commercial Officer Dr. Kumar Budur - Chief Medical Officer Sandip Kapadia - Chief Financial Officer Conference Call Participants Alex Sklar - Raymond James David Amsellem - Piper Sandler Francois Brisebois - Oppenheimer Graig Suvannavejh - Mizuho Securities Jason Gerberry - Bank of A ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) Table of Contents ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended June 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) (State or othe ...

Harmony Biosciences Holdings, Inc. (NASDAQ:HRMY) Q1 2023 Earnings Conference Call May 2, 2023 8:30 AM ET Company Participants Luis Sanay - Head, IR Jeffrey Dayno - President and CEO Jeffrey Dierks - CCO Sandip Kapadia - CFO Conference Call Participants Charles Duncan - Cantor Fitzgerald Francois Brisebois - Oppenheimer David Amsellem - Piper Sandler Graig Suvannavejh - Mizuho Securities Ami Fadia - Needham Corinne Jenkins - Goldman Sachs Jason Gerberry - Bank of America Danielle Brill - Raymond James Operat ...

Our Corporate Growth Strategy Acquire New Assets WAKIX® Net Revenue Performance U.S. Covered Lives With Formulary Access >80% Average # of Patients on WAKIX ~5,100 Continued Growth in Depth & Breadth of Prescriber Base ~85% In-Person Access to HCPs 1. Includes New Drug Applications and supplemental New Drug Applications. 2. Trial conducted by Bioprojet and Bioprojetsubmitted regulatory package to EMA. Bioprojet received EMA approval on March 15, 2023. | --- | --- | --- | --- | --- | --- | --- | --- | |----- ...