公司动态 - 公司管理层将于2025年6月11日美国东部时间上午9:20在高盛2025年度全球医疗健康会议上进行演讲 [1] - 该活动将通过公司官网投资者关系板块进行网络直播 直播内容将在活动结束后保留30天 [2] 公司概况 - 公司是一家以患者为中心的全球生物制药企业 致力于开发同类首创和最优疗法以改善重症患者生活 [3] - 公司拥有多元化的已上市和中后期在研药物管线 同时开展前沿药物发现研究 [3] - 公司最先进的研发项目集中在肺部疾病和炎症领域 其中一款疗法已在美国、欧洲和日本获批用于治疗慢性衰弱性肺部疾病 [3] - 早期研发项目涵盖多种技术和治疗方式 包括基因治疗、AI驱动的蛋白质工程、蛋白质制造、RNA末端连接和合成拯救等 [3] 公司布局 - 公司总部位于美国新泽西州布里奇沃特 在美国、欧洲和日本设有办公室和研究中心 [4] - 公司连续四年被评为科学领域最佳雇主第一名 是生物制药行业最佳雇主之一 [4]

—    Insmed Presented 11 Abstracts at ATS 2025 from Across Its Respiratory Portfolio, Including Data on ARIKAYCE®, TPIP and Health Economics and Outcomes Research   —BRIDGEWATER, N.J., May 21, 2025 /PRNewswire/ -- Insmed Incorporated (Nasdaq: INSM), a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases, presented 11 new abstracts at the American Thoracic Society (ATS) 2025 International Conference, wh ...

纪要涉及的行业和公司 - 行业：医疗保健行业 - 公司：Insmed (INSM) 纪要提到的核心观点和论据 TPIP药物相关 - **成功标准**：公司认为在PAH研究中，肺血管阻力（PVR）降低20%为明确胜利，因多数类似试验该指标降低在12 - 19%；六分钟步行距离在治疗组较安慰剂组改善15 - 20米也视为胜利 [2][3][5]。 - **差异化优势**：TPIP为每日一次用药，而现有最佳吸入性前列腺素类药物需每日四次用药，且患者无夜间覆盖；TPIP能在24小时内持续发挥作用，方便性和夜间覆盖是重大进步 [6][7]。 - **研究设计选择PVR的原因**：二期研究测量PVR是因其为肺血管阻力的直接测量指标，患者因右心衰竭死亡，PVR大幅下降意味着右心负担减轻，理论上患者寿命可能延长；六分钟步行试验虽能体现运动能力，但16周的研究时间可能无法完全体现其改善效果 [9]。 - **安全性**：吸入性药物的副作用如潮红、头痛、恶心等会导致患者停药，公司设计的分子可减少导致停药的咳嗽，通过将16碳链与曲前列尼尔分子用酯键连接，使药物在肺内激活，降低峰值、延长谷值，持续扩张血管，有望降低不良事件发生率 [12][13]。 - **剂量相关**：公司在开放标签研究中已能将部分患者剂量滴定至1280微克；二期研究最大剂量为640微克，高于竞品每日最大标签剂量54微克的60%以上；根据不良事件分析和临床疗效趋势，关键意见领袖和FDA同意提高剂量，即将公布的二期数据可能被低估 [19][20][24]。 - **风险评估**：去年PH ILD研究数据因样本量小（约39名患者），去风险作用有限，但患者临床恶化时间有改善，预计三期研究将持续改善 [17]。 - **长期战略**：若数据理想，公司不考虑分拆TPIP；公司目前现金充裕（12亿美元），ARIkayce预计今年营收超4亿美元，二期研究数据积极，有望成为十亿美元级药物；此外还有布伦索卡替（brensocatib）在支气管扩张症、CRS无鼻息肉、化脓性汗腺炎等疾病的研究，各化合物已有一定去风险基础且有多个潜在适应症 [26][27][28]。 - **FDA审批与后续计划**：若数据有说服力，PAH的三期试验有望快速招募患者；PH ILD将在今年年底前启动三期试验，PAH紧随其后；不期望FDA有特殊对待，按历史模式推进 [30][31]。 布伦索卡替（Brensocatib）相关 - **中期审查情况**：与FDA的沟通顺利，审查按计划或提前进行，FDA提问符合预期且数量不多；欧洲和英国已接受提交，欧洲处于快速通道；药物不良事件谱与安慰剂相当，有明确的主要终点和多个次要终点胜利，有望顺利获批 [33][34][35]。 - **标签与市场预期**：预计标签为支气管扩张症治疗，不与病情加重相关；市场准入将限制为过去12个月内有两次或更多病情加重且通过CT扫描确诊的患者，美国约有25万此类患者，市场机会大；峰值销售额预计超5亿美元，主要由市场准入驱动 [37][38][40]。 - **更广泛人群潜力**：美国约有2000万COPD患者，文献显示4 - 60%可能患有支气管扩张症，随着患者确诊，潜在患者数量可能成倍增加 [41]。 - **教育与推广挑战**：推广过程顺利，该药物是机制和疾病领域的首创，二、三期研究数据发表在《新英格兰医学杂志》，肺科界热情高涨 [44]。 - **处方医生选择**：目前专注于肺科医生群体，美国约有2.9万名肺科医生，销售团队已与他们建立关系；维罗纳（Verona）的成功案例表明针对肺科医生群体可有效接触患者 [46][47]。 - **支付方接受度**：市场准入方面，支付方对药物减少肺部病情加重、保留肺功能以及改善生活质量的效果反应积极 [49][50]。 - **后续研究信心**：布伦索卡替的DPP - 1作用机制新颖，在支气管扩张症之后，有望用于CRS无鼻息肉（美国约3200万患者）和化脓性汗腺炎等疾病；化学实验室已合成750多种DPP - 1化合物，明年将在类风湿关节炎、COPD等疾病的临床试验中应用 [52][53][54]。 公司整体执行能力 公司有信心执行多项业务，原因在于公司在13年内从少数人发展到超1500人，招聘有针对性，企业文化明确，员工能把握机会并取得进展 [56]。 其他重要但可能被忽略的内容 - 去年PAHLD研究中完成研究的患者95%进入开放标签扩展阶段，表明患者对药物体验积极 [16]。 - 病情加重对患者肺部造成永久性损伤，公司希望积极治疗频繁病情加重的患者以防止进一步损伤 [43]。

Insmed (INSM) reported a first-quarter 2025 loss of $1.42 per share, which was wider than the Zacks Consensus Estimate of a loss of $1.36. In the year-ago quarter, the company posted a loss of $1.06 per share.The company generated total quarterly revenues of $92.8 million, which rose 23% year over year. Quarterly sales were in line with the Zacks Consensus Estimate. (Find the latest EPS estimates and surprises on Zacks Earnings Calendar)INSM Stock’s PerformanceShares of the company were down 4% yesterday, l ...

Insmed (INSM) came out with a quarterly loss of $1.42 per share versus the Zacks Consensus Estimate of a loss of $1.36. This compares to loss of $1.06 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -4.41%. A quarter ago, it was expected that this biopharmaceutical developing inhaled treatments for patients battling rare lung diseases would post a loss of $1.15 per share when it actually produced a loss of $1.32, delivering a ...

Insmed (INSM) Q1 2025 Earnings Call May 08, 2025 08:00 AM ET Company Participants Bryan Dunn - Vice President, Head of Investor RelationsWilliam Lewis - Chair and Chief Executive OfficerSara Bonstein - CFOJason Zemansky - Vice President, Equity Research, Biotechnology and PharmaceuticalsMartina Flammer - Chief Medical OfficerJoseph Schwartz - Senior Managing DirectorDaniel Krizay - VP - Biotech Equity ResearchJennifer Kim - Equity Research DirectorLiisa Bayko - Managing DirectorGraig Suvannavejh - Managing ...

Insmed (INSM) Q1 2025 Earnings Call May 08, 2025 08:00 AM ET Speaker0 Thank you for standing by. My name is Amy, and I will be your conference operator for today. At this time, I would like to welcome everyone to the Insmed First Quarter twenty twenty five Financial Results Call. All participants have been placed in a listen only mode. After the speakers' remarks, we will conduct a question and answer session. It is now my pleasure to turn the call over to Brian Dunn. You may begin. Speaker1 Thank you, Amy. ...

May 8, 2025 First-Quarter 2025 Earnings Presentation 1 Forward Looking Statements This presentation contains forward-looking statements that involve substantial risks and uncertainties. "Forward-looking statements," as that term is defined in the Private Securities Litigation Reform Act of 1995, are statements that are not historical facts and involve a number of risks and uncertainties. Words herein such as "may," "will," "should," "could," "would," "expects," "plans," "anticipates," "believes," "estimates ...

Exhibit 99.1 Insmed Reports First-Quarter 2025 Financial Results and Provides Business Update —ARIKAYCE® (amikacin liposome inhalation suspension) Total Revenue of $92.8 Million for the First Quarter of 2025, Reflecting 23% Growth Over the First Quarter of 2024— —NDA for Brensocatib in Patients with Bronchiectasis Remains on Track, with a PDUFA Target Action Date of August 12, 2025— —Phase 2b Study of TPIP in Patients with PAH Completed; Topline Data Expected in June 2025— —Enrollment Completed for Phase 2b ...

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 March 31, 2025 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 000-30739 INSMED INCORPORATED (Exact name of registrant as specified in its charter) Virginia 54-1972729 (State or other jurisdictio ...