Core Insights - Insmed Incorporated announced positive results from the pivotal phase 3 ASPEN study of brensocatib, demonstrating a statistically significant reduction in pulmonary exacerbations in patients with non-cystic fibrosis bronchiectasis [1][2] - Brensocatib is currently under Priority Review with the U.S. FDA, with a target action date of August 12, 2025 [5] Study Results - The ASPEN study is the largest clinical trial ever conducted in bronchiectasis, involving 1,680 adult patients and 41 adolescent patients across 391 sites in 35 countries [6][7] - The annualized rate of pulmonary exacerbations was significantly lower in the brensocatib groups: 1.02 for 10 mg, 1.04 for 25 mg, compared to 1.29 for placebo, with rate ratios of 0.79 (P=0.004) and 0.81 (P=0.005) respectively [2][3] - Both dosage strengths of brensocatib also met secondary endpoints, including prolonging time to first exacerbation and increasing the proportion of patients remaining exacerbation-free [3] Safety and Tolerability - Brensocatib was well-tolerated, with treatment-emergent adverse events (TEAEs) occurring in at least 5% of patients, including COVID-19, nasopharyngitis, cough, and headache [4] Market Potential - Approximately 500,000 patients in the U.S., 600,000 in the EU5, and 150,000 in Japan are diagnosed with bronchiectasis, highlighting a significant unmet medical need [7] - Brensocatib has the potential to be the first approved therapy for bronchiectasis and the first DPP1 inhibitor, addressing a range of neutrophil-mediated inflammatory diseases [5][8] Company Overview - Insmed is a global biopharmaceutical company focused on delivering first- and best-in-class therapies for serious diseases, with a diverse portfolio of investigational medicines [9][10]

—New Analyses from the Phase 3 ASPEN Study Examining Efficacy and Safety of Brensocatib Across a Variety of Prespecified Subgroups——Data from ASPEN Post-hoc Analysis Evaluating Changes in Lung Function in Bronchiectasis Patients Who Did or Did Not Experience Pulmonary Exacerbations in the Trial——Data on Health Status Improvements Over Time Following Culture Conversion in Patients with Mycobacterium Avium Complex (MAC) Lung Disease—BRIDGEWATER, N.J., March 25, 2025 /PRNewswire/ -- Insmed Incorporated (Nasdaq ...

Core Insights - Insmed's international operations are crucial for assessing its financial resilience and growth prospects, especially in the context of a global economy [1][2][3] Financial Performance - For the quarter ended December 2024, Insmed reported total revenue of $104.44 million, marking a 24.8% increase year over year [4] - Japan contributed $30.7 million, accounting for 29.39% of total revenue, with a slight miss of -0.07% against analyst expectations [5] - Revenue from Europe and the rest of the world was $5.9 million, representing 5.65% of total revenue, also missing projections by -0.51% [6] Future Projections - Analysts expect Insmed to report total revenue of $94.72 million in the current fiscal quarter, indicating a 25.5% increase from the prior year [7] - For the full year, total revenue is projected at $467.34 million, reflecting a 28.5% increase from the previous year, with Japan and Europe expected to contribute $116.82 million and $24.1 million, respectively [8] Market Dynamics - Insmed's reliance on international markets presents both opportunities and challenges, necessitating close monitoring of revenue trends for accurate future projections [9][10]

—FDA Reaffirms Application is Under Priority Review with a PDUFA Target Action Date of August 12, 2025—BRIDGEWATER, N.J., Feb. 24, 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, today announced that the U.S. Food and Drug Administration (FDA) has informed the Company that it does not currently plan to hold an advisory committee meeting t ...

Insmed (INSM) reported a fourth-quarter 2024 loss of $1.32 per share, wider than the Zacks Consensus Estimate of a loss of $1.15. In the year-ago quarter, the company posted a loss of $1.28 per share.Insmed generated total quarterly revenues of $104.4 million, which rose 25% year over year. Quarterly sales were in line with the Zacks Consensus Estimate.See the Zacks Earnings Calendar to stay ahead of market-making news.Shares of INSM were down more than 4% in after-market trading on Thursday likely due to t ...

Insmed Incorporated (NASDAQ:INSM) Q4 2024 Earnings Call February 20, 2025 8:00 AM ET Company Participants Bryan Dunn - Investor Relations Will Lewis - Chair and Chief Executive Officer Sara Bonstein - Chief Financial Officer Martina Flammer - Chief Medical Officer Conference Call Participants Vamil Divan - Guggenheim Securities Joe Schwartz - Leerink Partners Jessica Fye - JPMorgan Ritu Baral - TD Cowen Andrea Newkirk - Goldman Sachs Nicole Germino - Truist Securities Graig Suvannavejh - Mizuho Securities J ...

Insmed (INSM) reported $104.44 million in revenue for the quarter ended December 2024, representing a year-over-year increase of 24.8%. EPS of -$1.32 for the same period compares to -$1.28 a year ago.The reported revenue represents a surprise of +0.10% over the Zacks Consensus Estimate of $104.34 million. With the consensus EPS estimate being -$1.15, the EPS surprise was -14.78%.While investors closely watch year-over-year changes in headline numbers -- revenue and earnings -- and how they compare to Wall S ...

Insmed (INSM) came out with a quarterly loss of $1.32 per share versus the Zacks Consensus Estimate of a loss of $1.15. This compares to loss of $1.28 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -14.78%. A quarter ago, it was expected that this biopharmaceutical developing inhaled treatments for patients battling rare lung diseases would post a loss of $1.19 per share when it actually produced a loss of $1.27, delivering a ...

Exhibit 99.1 Insmed Reports Fourth-Quarter and Full-Year 2024 Financial Results and Provides Business Update —ARIKAYCE® (amikacin liposome inhalation suspension) Total Revenue of $104.4 Million for Fourth-Quarter and $363.7 Million for Full-Year 2024, Reflecting 19% Annual Growth and Exceeding the Upper End of Full-Year 2024 Guidance Range— —Company Reiterates 2025 Global ARIKAYCE Revenue Guidance of $405 Million to $425 Million, Reflecting Double-Digit Growth Compared to 2024— —NDA for Brensocatib in Patie ...

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 EXCHANGE ACT OF 1934 For the fiscal year ended December 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 0-30739 INSMED INCORPORATED (Exact name of registrant as specified in its charter) Virginia (State or other jurisdiction of incorporation o ...