Summary of Insmed (INSM) 2025 Conference Call Company Overview - **Company**: Insmed (INSM) - **Event**: 2025 Conference on May 13, 2025 - **Key Speaker**: Will Lewis, Chair and CEO of Insmed Key Points Discussed 1. Focus on TPIP Phase Two Asset - Investors are particularly interested in the phase two asset TPIP, with data expected in June 2025 [2][24] - A success benchmark for TPIP is set at a 20% reduction in pulmonary vascular resistance (PVR) [3][4] - The six-minute walk test improvement of 15 to 20 meters is also considered a win [5] 2. Differentiation of TPIP - TPIP is designed as a once-a-day medication, contrasting with current inhaled prostanoids that require four times a day administration [6][7] - The formulation aims to provide nighttime coverage, which is a significant improvement for patient compliance [7] 3. Rationale for Study Design - The focus on PVR as a primary endpoint is due to its direct measurement of pulmonary vascular resistance, which is critical for patients with pulmonary arterial hypertension (PAH) [9][10] - The study duration of 16 weeks may not capture the full benefit of the six-minute walk improvement, hence the emphasis on PVR [10] 4. Safety Profile - Safety is crucial, especially for inhaled drugs, with common side effects leading to discontinuation in existing therapies [12] - The design of TPIP aims to reduce cough sensitivity, a common issue with inhaled drugs [13][16] 5. Market Potential and Growth Strategy - Insmed has $1.2 billion in cash and forecasts ARIKAYCE to generate over $400 million in revenue [27] - The potential market for ARIKAYCE could expand significantly with upcoming phase three data [27] - Brensocatib is expected to target multiple indications, including bronchiectasis and hidradenitis suppurativa, with significant market potential [28][52] 6. Regulatory Engagement - The FDA review process for Insmed's products has been smooth, with no significant issues raised [33][34] - The company is on track for timely submissions and approvals, with a focus on market access strategies [39][40] 7. Market Access and Pricing Strategy - The market access strategy is focused on patients with two or more exacerbations and a definitive diagnosis of bronchiectasis [37][40] - Insmed is optimistic about the drug's ability to preserve lung function and improve quality of life, which is appealing to payers [49][50] 8. Future Indications and Research - Insmed is exploring additional indications for brensocatib, including neutrophil-driven diseases like CRS and HS [52][54] - The company is developing new DPP-1 inhibitors for various diseases, indicating a robust pipeline for future growth [54][55] 9. Confidence in Execution - The growth of Insmed's workforce and deliberate hiring practices contribute to the company's confidence in executing its strategic plans [56] Additional Insights - The skepticism from the investment community regarding TPIP's dosing and efficacy is acknowledged, but the company remains optimistic about upcoming data [24][22] - The potential for a truncated phase three trial is discussed, contingent on the strength of the phase two data [30] This summary encapsulates the critical discussions and insights from the Insmed conference call, highlighting the company's strategic focus, product pipeline, and market positioning.

Core Viewpoint - Insmed reported a wider-than-expected loss in Q1 2025, with total revenues showing a year-over-year increase driven by its sole marketed drug, Arikayce [1][4][5]. Financial Performance - Insmed's Q1 2025 loss was $1.42 per share, compared to the Zacks Consensus Estimate of a loss of $1.36 and a loss of $1.06 per share in the same quarter last year [1]. - Total quarterly revenues reached $92.8 million, reflecting a 23% increase year over year, aligning with the Zacks Consensus Estimate [1]. - The company's stock declined by 4% following the earnings miss, and year-to-date, the stock has lost 9%, while the industry has seen a 5% decline [2]. Revenue Breakdown - All revenues in the reported quarter were generated from Arikayce, which is approved for treating refractory mycobacterium avium complex lung disease [4]. - Sales of Arikayce increased by 14% to $64.3 million in the U.S., 48% to $22.1 million in Japan, and 52% to $6.5 million in Europe and the rest of the world [5]. Expense Analysis - Research and development expenses rose by 26% year over year to $152.6 million, while selling, general, and administrative expenses increased by 58% to $147.5 million [6]. - The increase in expenses is attributed to a rise in employee headcount, leading to higher compensation and benefit-related expenses, as well as stock-based compensation costs [6]. Cash Position - As of March 31, 2025, Insmed had cash, cash equivalents, and marketable securities totaling approximately $1.2 billion, down from $1.4 billion as of December 31, 2024 [7]. Guidance and Future Outlook - Insmed maintained its sales guidance for Arikayce for the full year, expecting product sales to be between $405 million and $425 million, indicating a 14% year-over-year growth at the midpoint [9]. - The company is progressing with its pipeline, including a confirmatory phase III study for Arikayce and regulatory filings for brensocatib [10][11].

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 ...

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]

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 ...

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 ...

About Insmed Insmed Incorporated is a people-first global biopharmaceutical company striving to deliver first- and best-in- class therapies to transform the lives of patients facing serious diseases. The Company is advancing a diverse portfolio of approved and mid- to late-stage investigational medicines as well as cutting-edge drug discovery focused on serving patient communities where the need is greatest. Insmed's most advanced programs are in pulmonary and inflammatory conditions, including a therapy ap ...