Financial Data and Key Metrics Changes - Insmed reported strong commercial performance with ARIKAYCE achieving double-digit year-over-year revenue growth in Q1 2025, marking the sixth consecutive quarter of such growth [6][25] - The company maintains its full-year ARIKAYCE net revenue guidance of $400 to $425 million, excluding any contributions from brensocatib if approved [26] - As of the end of Q1 2025, Insmed's cash balance stood at approximately $1.2 billion, positioning the company well for upcoming clinical and commercial catalysts [26][28] Business Line Data and Key Metrics Changes - ARIKAYCE experienced a 14% growth in the U.S. market, with Japan and Europe showing impressive growth rates around 50% [25][26] - The company is advancing three mid to late-stage programs: brensocatib, TPIP, and ARIKAYCE, with all programs on or ahead of schedule [6][7] Market Data and Key Metrics Changes - The disease state awareness website for bronchiectasis received over one million unique visits, indicating strong patient interest and engagement [10] - Insmed has successfully engaged with over 27,000 healthcare professionals in the U.S. regarding bronchiectasis and ARIKAYCE [10] Company Strategy and Development Direction - Insmed is focused on a frictionless launch for brensocatib, aiming for easy access and rapid uptake among patients [41][96] - The company is expanding its U.S. manufacturing footprint to mitigate tariff impacts and ensure a robust supply chain for brensocatib [24][81] - Insmed is also exploring next-generation DPP1 inhibitors for conditions like COPD and rheumatoid arthritis, indicating a commitment to addressing unmet medical needs [70][72] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming FDA decision on brensocatib, expected by August 12, 2025, and highlighted the positive reception from regulatory authorities [6][9] - The company is well-positioned to thrive amid geopolitical uncertainties, with minimal tariff exposure anticipated [23][24] Other Important Information - Insmed's operating expenses for Q1 2025 were consistent with historical performance, with a cost of product revenues at 22.9% of revenues [29] - The company announced the calling of $570 million of convertible debt, which could lead to the issuance of approximately 17.8 million additional shares if converted [28] Q&A Session Summary Question: What factors influence brensocatib pricing in the U.S. and abroad? - Management indicated that pricing flexibility exists due to the sequential pricing strategy across regions, allowing for adjustments based on market conditions [36] Question: What trends are observed from the bronchiectasis disease awareness website? - There is a favorable backdrop with high patient interest and enthusiasm, paralleling physician engagement [40] Question: What are the key levers for transitioning interested patients to therapy? - The focus is on connecting diagnosed patients with treatment, particularly those with two or more exacerbations [46] Question: How does the company view the importance of PVR versus six-minute walk in TPIP trials? - PVR is considered the most definitive measure, while six-minute walk is viewed as a less specific but still relevant measure [58] Question: What is the status of inspections related to brensocatib's review? - No surprises were reported from the mid-cycle review, and inspections are ongoing as part of the approval process [75] Question: Can you clarify the patient population for bronchiectasis in the U.S.? - Approximately 500,000 patients are diagnosed with bronchiectasis, with about half having had two or more exacerbations in the last twelve months [90]

Financial Data and Key Metrics Changes - Insmed reported strong commercial performance with double-digit year-over-year growth in ARIKAYCE across all geographic regions, marking the sixth consecutive quarter of such growth [22][24] - The cash balance at the end of the quarter was approximately $1.2 billion, indicating a well-capitalized position as the company approaches upcoming clinical and commercial catalysts [24] - Operating expenses for Q1 2025 were $21.3 million, or 22.9% of revenues, consistent with historical performance, although R&D and SG&A expenses were higher than the previous year due to growth initiatives [27][28] Business Line Data and Key Metrics Changes - ARIKAYCE achieved a remarkable 14% growth in the U.S. market, with Japan and Europe showing growth rates around 50% [22][23] - The company anticipates ARIKAYCE net revenue guidance for 2025 to be between $400 million and $425 million, exclusive of any contributions from brensocatib [24] Market Data and Key Metrics Changes - The disease state awareness website for bronchiectasis received over one million unique visits, with more than 53,000 patients taking action to stay informed [8] - The company has engaged with over 27,000 healthcare professionals in the U.S. to educate them about bronchiectasis and ARIKAYCE [8] Company Strategy and Development Direction - Insmed is focused on advancing three mid to late-stage programs: brensocatib, TPIP, and ARIKAYCE, with positive clinical data supporting their potential [5][6] - The company is preparing for the launch of brensocatib, with regulatory reviews progressing in the U.S., Europe, and Japan, aiming for potential approvals in 2026 [9][10] - Insmed is expanding its U.S. manufacturing footprint to mitigate tariff impacts and ensure a robust supply chain for brensocatib [21][22] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's position to thrive despite geopolitical uncertainties and tariff impacts, estimating a minimal annual impact in the single-digit millions [20][21] - The management team is optimistic about the upcoming launch of brensocatib, expecting a favorable landscape for patient uptake and physician engagement [37][39] Other Important Information - The company is actively working on next-generation DPP1 inhibitors, targeting conditions like COPD and rheumatoid arthritis, with potential clinical trials expected to start next year [12][70] - Insmed plans to finalize clinical plans for phase three trials of TPIP based on data from ongoing phase two trials, with expectations for significant efficacy [16][17] Q&A Session Summary Question: What factors will influence the pricing of brensocatib in the U.S. and abroad? - Management indicated that pricing will be set in the U.S. first, allowing flexibility to respond to market conditions, with ARIKAYCE priced at parity across regions during its launch [34][35] Question: What trends are observed from the bronchiectasis disease awareness website? - Management noted a favorable backdrop with high patient interest and engagement, indicating readiness for a successful launch [37][39] Question: What are the key levers for transitioning interested patients to therapy? - The company is focusing on connecting diagnosed patients with treatment options and leveraging existing relationships in the pulmonology community to facilitate access [42][45] Question: How is the company preparing for the TPIP update? - Management emphasized the importance of pulmonary vascular resistance (PVR) as a key measure, with expectations for a placebo-adjusted reduction of 20% to indicate success [55][56] Question: What is the status of the brensocatib review process? - The FDA review process is on track, with no surprises reported during the mid-cycle review, and ongoing inspections are expected until the approval date [74][75]

Financial Performance & Outlook - ARIKAYCE worldwide sales reached $92.8 million in Q1 2025, a 22.9% increase compared to $75.5 million in Q1 2024[47] - The company reiterates its 2025 ARIKAYCE revenue guidance of $405 to $425 million[57] - The company had approximately $1.2 billion in cash, cash equivalents, and marketable securities as of March 31, 2025[59] - The company called remaining convertible debt of approximately $570 million, expecting conversion to lower ongoing interest expense and reduce outstanding debt[61] Clinical Program Updates - Brensocatib's FDA review is on track, with a PDUFA target action date of August 12th for potential U.S approval[16] - Phase 3 ASPEN results for Brensocatib in Bronchiectasis were published in NEJM[28] - Phase 2b BiRCh trial for Brensocatib in CRSsNP enrolled 288 patients, with topline readout expected by YE:25[28] - Phase 2b PAH trial topline readout for TPIP is expected in June 2025, with a potential Phase 3 trial initiation in 2H:25[37, 39] - Phase 3 ENCORE trial for ARIKAYCE is progressing on schedule, with topline readout expected in 1H:26[46, 48] Market Engagement - Approximately 53,000 patients have engaged in a high-value action on SpeakUpInBronchiectasis.com[26, 27]

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 ...

The market expects Insmed (INSM) to deliver a year-over-year decline in earnings on higher revenues when it reports results for the quarter ended March 2025. This widely-known consensus outlook is important in assessing the company's earnings picture, but a powerful factor that might influence its near-term stock price is how the actual results compare to these estimates.The earnings report, which is expected to be released on May 8, 2025, might help the stock move higher if these key numbers are better tha ...

Company Overview - Insmed Incorporated is a global biopharmaceutical company focused on delivering first- and best-in-class therapies for patients with serious diseases [3][4] - The company is advancing a diverse portfolio of approved and investigational medicines, particularly in pulmonary and inflammatory conditions [3] - Insmed's advanced programs include a therapy approved in the United States, Europe, and Japan for a chronic lung disease [3] Upcoming Event - Management will present at the BofA Securities 2025 Health Care Conference on May 13, 2025, at 2:20 p.m. PT [1] - The event will be webcast live and available for 30 days post-event on the company's investor relations website [2] Company Recognition - Insmed has been recognized as one of the best employers in the biopharmaceutical industry, including being named the No. 1 Science Top Employer for four consecutive years [4]

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]

Core Insights - Insmed Incorporated will present 11 abstracts from its respiratory portfolio at the ATS 2025 International Conference, focusing on the efficacy and safety of brensocatib and health outcomes in patients with Mycobacterium Avium Complex lung disease [1][2][26] Group 1: Company Overview - Insmed is a global biopharmaceutical company dedicated to developing first- and best-in-class therapies for serious diseases [1][26] - The company is advancing a diverse portfolio of approved and investigational medicines, particularly in pulmonary and inflammatory conditions [26][27] Group 2: Research and Development - The Phase 3 ASPEN study is the largest clinical trial in bronchiectasis to date, evaluating brensocatib's performance across various patient subgroups [2][6] - New health economics and outcomes research related to MAC lung disease will also be presented, highlighting treatment patterns and health status improvements [1][3] Group 3: Upcoming Presentations - Presentations will include analyses of treatment patterns in non-cystic fibrosis bronchiectasis and healthcare resource utilization for MAC lung disease [3] - Specific sessions will focus on the efficacy of brensocatib in patients with different backgrounds, including those with eosinophilic bronchiectasis [3][9]

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]