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, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | --- | --- | |---------------------------------------------------------------------------------------------------|---------------------------------------------------- ...

财务数据和关键指标变化 - 2024年前九个月总收入为1.456亿美元，同比下降1% [24] - 2024年前九个月净亏损为1400万美元，而2023年同期净收入为490万美元 [32] - 2024年第三季度总收入为4770万美元，同比增长23% [37] - 2024年第三季度净亏损为530万美元，而2023年同期净收入为10万美元 [41] 各条业务线数据和关键指标变化 - Fanapt在2024年前九个月的净产品销售为6760万美元，同比下降1% [25] - Hetlioz在2024年前九个月的净产品销售为5660万美元，同比下降28% [26] - PONVORY在2024年前九个月的净产品销售为2130万美元，反映出产品组合的多样化 [30] - 2024年第三季度Fanapt净产品销售为2390万美元，同比增长12% [38] - 2024年第三季度Hetlioz净产品销售为1790万美元，同比增长2% [39] - 2024年第三季度PONVORY净产品销售为590万美元，同比下降32% [40] 各个市场数据和关键指标变化 - Fanapt的销售团队已扩展至约150名代表，计划在年底前增至200名 [8][46] - PONVORY的销售团队约为30名，专注于多发性硬化症专家 [78] 公司战略和发展方向和行业竞争 - 公司专注于Fanapt和PONVORY的商业化，计划在2025年推出milsaperidone的NDA申请 [9][21] - 公司计划在2024年启动Fanapt LAI的III期临床试验 [68] - PONVORY在其他自身免疫性疾病中的潜在应用正在开发中，包括银屑病和溃疡性结肠炎 [15][72] 管理层对经营环境和未来前景的评论 - 管理层对Fanapt的市场反应表示乐观，NBRx指标显示新患者启动增长超过90% [45] - 管理层预计2024年总净产品销售将达到1.9亿至2.1亿美元，较之前的预期有所上调 [48] 其他重要信息 - 2025年1月1日起，医疗保险福利重组将对公司产品的毛利产生负面影响 [31] - 公司现金及现金等价物截至2024年9月30日为3.763亿美元，较2023年12月31日减少1200万美元 [35] 问答环节所有提问和回答 问题: 关于Fanapt的销售代表的反馈 - 管理层表示，Fanapt的新患者启动增长显著，销售代表的互动次数增加了三到四倍，表明市场反应良好 [53][55] 问题: 关于PONVORY的销售团队规模 - PONVORY的销售团队约为30名，专注于多发性硬化症的专家 [78] 问题: 关于Fanapt LAI的临床试验时间表 - Fanapt LAI的III期临床试验预计将在2024年第四季度启动 [68] 问题: 关于milsaperidone的NDA申请 - NDA申请的主要限制因素是稳定性数据的可用性，预计在2024年第一季度获得 [60] 问题: 关于PONVORY在其他适应症的潜在应用 - 公司已提交了针对溃疡性结肠炎的IND申请，并计划在明年启动相关工作 [72]

Exhibit 99.1 Vanda Pharmaceuticals Reports Third Quarter 2024 Financial Results • Revenues for Q3 2024 were $47.7 million, an increase of 23% compared to Q3 2023 • Financial Guidance revised for Full Year 2024, raising the midpoint of revenue and cash ranges ® • Fanapt launch in bipolar I disorder; new patient starts increased by over 90% in Q3 2024 as compared to Q3 2023 • Fanapt long acting injectable program expected to be initiated in Q4 2024 ® • Milsaperidone NDA for schizophrenia and bipolar I disorde ...

HC Wainwright initiated coverage on Vanda Pharmaceuticals, Inc. VNDA, a commercial-stage biopharmaceutical firm primarily focusing on neurological and neuropsychiatry disorders.HC Wainwright sees Vanda as having a well-established commercial portfolio, with multiple line extensions and life cycle management opportunities across its three key franchises: Fanapt, Hetlioz, and Ponvory.The analyst notes a pipeline of promising programs with numerous opportunities for significant clinical and regulatory mileston ...

Conference Call and Webcast to FollowWASHINGTON, Oct. 30, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced it will release results for the third quarter 2024 on Wednesday, November 6, 2024, after the market closes.Vanda will host a conference call at 4:30 PM ET on Wednesday, November 6, 2024, during which management will discuss the third quarter 2024 financial results and other corporate activities. To participate in the conference call, please dial 1-800-715-9871 (dom ...

文章核心观点 - 公司董事会一致拒绝了Cycle Group提出的第二次收购提议,认为该提议严重低估了公司价值,不符合公司及股东利益 [1] - 公司股价在该消息公布后上涨8.3% [2] - 公司此前也曾拒绝过Future Pak提出的收购提议,认为该提议严重低估了公司价值 [3] 公司概况 - 公司拥有三款商业化产品Hetlioz、Fanapt和Ponvory [4] - Fanapt用于治疗精神分裂症和双相情感障碍 [4] - Hetlioz用于治疗非24小时睡眠-觉醒障碍和Smith-Magenis综合征 [4] - 公司从强生公司收购了Ponvory在美国和加拿大的权利,该药物用于治疗复发型多发性硬化症 [4] 管线产品 - 公司的管线产品tradipitant在治疗胃轻瘫症状方面遭遇了FDA的完全回应信 [5] - 公司正在评估tradipitant用于治疗晕动病的临床试验,计划于2024年第四季度向FDA提交新药申请 [5] 行业地位 - 公司目前被评为Zacks Rank 3(Hold) [6] - 同行业中,ANI Pharmaceuticals和Alnylam Pharmaceuticals被评为Zacks Rank 1(Strong Buy) [6][7] - 这两家公司近期业绩和股价表现良好 [6][7]

文章核心观点 - 万达制药公司(Vanda Pharmaceuticals Inc.)收到了来自Cycle Group Holdings Ltd.的第二次非约束性收购提议,提议以每股8美元的现金收购公司[1][2] - 万达公司董事会经过审慎评估后,一致认为该提议严重低估了公司的内在价值,不符合公司及其股东的最佳利益,因此决定不予接受[2][3] - 董事会认为Cycle Group的提议是一次机会主义的尝试,试图以折扣价收购公司股票[3] - 董事会和管理团队相信公司的增长前景、强大的现金头寸和高效的运营,将为股东创造远高于Cycle Group提议的长期价值[3] 公司概况 - 万达制药是一家全球领先的生物制药公司,专注于开发和商业化创新疗法,以满足高未满足的医疗需求,改善患者生活[4] 财务状况 - 公司拥有显著的现金余额[3] 业务发展 - 公司的临床开发管线、不断扩大的商业覆盖范围为长期价值创造奠定了基础[3]

Vanda Pharmaceuticals Inc. (VNDA) announced that the FDA issued a complete response letter (CRL) to its new drug application (NDA) seeking approval for its pipeline candidate, tradipitant for the treatment of symptoms in gastroparesis. Shares of the company were down 6.1% on Sept. 19 following the announcement of the news. Marked by delayed gastric emptying, gastroparesis is a serious condition that slows down the stomach's ability to empty its contents. The FDA has not approved any effective medicine for t ...

A regulator's decision drained the market's enthusiasm for the company. The end of the trading week likely can't come fast enough for Vanda Pharmaceuticals (VNDA -6.06%). The commercial-stage biotech's stock took an almost 6% hit on Thursday, following some dispiriting news about one of its investigational drugs. That compared unfavorably to the 1.7% increase in the S&P 500 index during that session. Stomach-disorder drug rejected Bad news about a pipeline product is a fact of life in the biotech and pharma ...

WASHINGTON, Aug. 29, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the company will participate in the Wells Fargo 2024 Healthcare Conference in Boston on Friday, September 6, 2024. A corporate presentation is scheduled for 11:00 a.m. Eastern Time. The corporate presentation given at the Wells Fargo 2024 Healthcare Conference may be accessed live on Vanda's corporate website, www.vandapharma.com. Investors should click on the Investors tab and follow the link un ...