财务数据和关键指标变化 - 总收入同比增长63%,连续8个季度实现收入增长,年化收入超过2.5亿美元 [27][31] - Tyvaso DPI 特许权使用费收入同比增长94%,达到2300万美元 [27] - 合作和服务收入同比增长118%,达到2500万美元,主要由于生产活动水平提高、销售给UT的Tyvaso DPI半成品数量和平均售价上升 [28] - Afrezza净收入同比增长16%,主要由于销售折扣率下降和价格上涨 [29] - V-GO收入下降16%,至400万美元,主要由于需求下降 [30] 各条业务线数据和关键指标变化 - Tyvaso DPI业务持续强劲增长,带动公司整体收入大幅增长 [27][28] - Afrezza业务增长7%,抵消了V-GO业务下滑 [17][18] - 公司调整销售团队重心,将更多资源投入Afrezza,导致V-GO业务下滑 [17][18] 各个市场数据和关键指标变化 - 公司正在积极拓展海外市场,目前约三分之二的胰岛素销售来自美国境外 [50] - 公司计划在印度获得Afrezza的上市批准,预计2025年实现上市 [47] 公司战略和发展方向及行业竞争 - 公司将继续专注于吸入式胰岛素和罕见肺部疾病领域,看好这些领域的发展前景 [5][6][11] - 公司正在推进Afrezza在1型糖尿病和妊娠糖尿病等领域的应用,并计划获得儿童适用的批准 [23][24] - 公司正在开发吸入式克劳法齐明治疗非结核性分枝杆菌肺部感染,并计划启动III期临床试验 [11][13] - 公司正在开发吸入式OFEV治疗特发性肺纤维化,计划尽快推进临床试验 [14][15][16] - 公司正在与合作伙伴UT探讨进一步合作机会,但目前主要专注于Tyvaso DPI业务 [61][62] 管理层对经营环境和未来前景的评论 - 公司收入增长势头强劲,有望在2024年实现超过2.5亿美元的年化收入 [5][10] - 公司在吸入式胰岛素和罕见肺部疾病领域取得重大进展,看好未来发展前景 [6][11] - 公司财务状况持续改善,现金流充沛,为未来发展奠定了良好基础 [10][34][37][38] 问答环节重要的提问和回答 问题1 **Anush提问** 询问INHALE-3试验的预期结果和启示 [55] **Michael Castagna回答** INHALE-3试验旨在证明Afrezza与当前公认的最佳标准治疗(人工胰岛素泵和MDI)疗效相当,公司有信心达到这一目标 [57][58][59] 问题2 **Olivia Breyer提问** 询问公司是否考虑就IPF项目寻找合作伙伴 [66] **Michael Castagna回答** 公司目前倾向于独立推进IPF项目的临床开发,认为自身已具备所需的商业化能力,但不排除未来寻求合作的可能性 [67][68][69][70] 问题3 **Thomas Smith提问** 询问公司在妊娠糖尿病领域的发展计划 [92][93][94][95] **Michael Castagna回答** 公司正在评估在该领域开展PK研究和参与相关临床试验的可能性,但目前尚未决定是否自主开展大规模临床试验 [92][93][94][95]

For the quarter ended March 2024, MannKind (MNKD) reported revenue of $66.26 million, up 63.1% over the same period last year. EPS came in at $0.05, compared to -$0.04 in the year-ago quarter.The reported revenue compares to the Zacks Consensus Estimate of $58.25 million, representing a surprise of +13.76%. The company delivered an EPS surprise of +150.00%, with the consensus EPS estimate being $0.02.While investors closely watch year-over-year changes in headline numbers -- revenue and earnings -- and how ...

MannKind财务表现 - MannKind发布的季度盈利为每股0.05美元，超过了Zacks Consensus Estimate的每股0.02美元[1] - MannKind在过去四个季度中四次超过了市场预期的每股盈利[2] - MannKind在2024年3月结束的季度实现了6626万美元的营收，超过了Zacks Consensus Estimate的1376%[3] - MannKind股价自年初以来上涨了约22.8%[4]

1Q 2024 Total revenues of $66M; +63% vs. 1Q 20231Q 2024 Net income of $11M; Non-GAAP net income of $15M$304M of cash and cash equivalents and investments at March 31, 2024In early April, repaid Midcap senior-secured debt and Mann Group convertible debt totaling approximately $37M FDA Fast Track designation and IND clearance received for MNKD-101 DANBURY, Conn. and WESTLAKE VILLAGE, Calif., May 08, 2024 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKD) today reported financial results for the quarter en ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 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: 000-50865 MannKind Corporation (Exact name of registrant as specified in its charter) Delaware 13-3607736 (State or other jurisdiction of in ...

EXHIBIT 99.1 mannkind MANNKIND CORPORATION REPORTS 2024 FIRST QUARTER FINANCIAL RESULTS: PROVIDES CLINICAL DEVELOPMENT UPDATE Conference Call to Begin Today at 5:00 p.m. (ET) • 1Q 2024 Total revenues of $66M; +63% vs. 1Q 2023 • 1Q 2024 Net income of $11M; Non-GAAP net income of $15M • $304M of cash and cash equivalents and investments at March 31, 2024 • In early April, repaid Midcap senior-secured debt and Mann Group convertible debt totaling approximately $37M • FDA Fast Track designation and IND clearanc ...

DANBURY, Conn. and WESTLAKE VILLAGE, Calif., May 06, 2024 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKD), a company focused on the development and commercialization of innovative inhaled therapeutic products and devices for patients with endocrine and orphan lung diseases, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation of Clofazimine Inhalation Suspension (MNKD-101) for the treatment of nontuberculous mycobacterial (NTM) lung disease. Fast track d ...

DANBURY, Conn. and WESTLAKE VILLAGE, Calif., May 01, 2024 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKD) will release its 2024 first quarter financial results and its management will host a conference call to discuss the financial results and corporate updates at 5:00 PM (Eastern Time) on Wednesday, May 8, 2024. Those interested in listening to the conference call live via the Internet may do so by visiting the Company's website at https://investors.mannkindcorp.com/events-and-presentations under Ev ...

First-in-human study to evaluate safety, tolerability and pharmacokinetics (PK) in healthy volunteersEnrollment of first study participant anticipated in June 2024 DANBURY, Conn. and WESTLAKE VILLAGE, Calif., April 30, 2024 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKD), a company focused on the development and commercialization of innovative inhaled therapeutic products and devices for patients with endocrine and orphan lung diseases, announced today that it will proceed with a first-in-human Phase ...

DANBURY, Conn. and WESTLAKE VILLAGE, Calif., April 29, 2024 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKD), a company focused on the development and commercialization of innovative inhaled therapeutic products and devices for patients with endocrine and orphan lung diseases, announced today that the U.S. Food and Drug Administration (FDA) has cleared the company's Investigational New Drug (IND) application for MNKD-101 (Clofazimine Inhalation Suspension), enabling the initiation of a Phase 3 study f ...