—ARIKAYCE® (amikacin liposome inhalation suspension) Total Revenue of $93.4 Million for the Third Quarter of 2024, Reflecting 18% Growth Over the Third Quarter of 2023——NDA Submission for Brensocatib in Bronchiectasis Remains on Track for the Fourth Quarter of 2024 with Potential U.S. Launch Still Expected in Mid-2025——Expanded U.S. Sales Force is Now Fully Deployed; Focusing on Bronchiectasis Disease-State Awareness and Supporting the Growth of ARIKAYCE Prior to the Anticipated Launch of Brensocatib——Ends ...

Wall Street analysts forecast that Insmed (INSM) will report quarterly loss of $1.19 per share in its upcoming release, pointing to a year-over-year decline of 8.2%. It is anticipated that revenues will amount to $93.31 million, exhibiting an increase of 18% compared to the year-ago quarter. The consensus EPS estimate for the quarter has undergone an upward revision of 0.8% in the past 30 days, bringing it to its present level. This represents how the covering analysts, as a whole, have reassessed their ini ...

Core Insights - Insmed Incorporated held its third annual Global Day of Good, with over 1,000 employees volunteering across the U.S., Europe, and Japan, marking the largest participation to date [1][2] - The activities focus on improving health, education, and human services, benefiting more than 40 organizations globally [1][2] - Insmed emphasizes a culture of community support, with various volunteer projects including preparing kits for pediatric cancer patients and revitalizing community centers [2][3] Company Overview - Insmed is a global biopharmaceutical company dedicated to delivering first- and best-in-class therapies for serious diseases, with a diverse portfolio of approved and investigational medicines [4] - The company is advancing programs primarily in pulmonary and inflammatory conditions, including a therapy approved in the U.S., Europe, and Japan for chronic lung disease [4] - Insmed is recognized as a top employer in the biopharmaceutical industry, having been named the No. 1 Science Top Employer for three consecutive years [5]

Core Points - Insmed Incorporated will release its third-quarter 2024 financial results on October 31, 2024 [1] - A conference call for investors will be held on the same day at 8:00 a.m. ET to discuss the financial results and provide a business update [2] - The conference call will be accessible via phone and will also be webcast live on the company's website [2] Company Overview - Insmed is a global biopharmaceutical company focused on delivering first- and best-in-class therapies for serious diseases [4] - The company has a diverse portfolio of approved and investigational medicines, particularly in pulmonary and inflammatory conditions [4] - Insmed is recognized as one of the best employers in the biopharmaceutical industry, having been ranked as the No. 1 Science Top Employer for three consecutive years [5]

—Data Presented at the CHEST 2024 Annual Meeting— BRIDGEWATER, N.J., Oct. 8, 2024 /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 presented positive late-breaking subgroup data from the Phase 3 ASPEN study, a global, randomized, double-blind, placebo-controlled Phase 3 study to assess the efficacy, safety, and tolerability of brensocatib ...

Core Insights - Short interest is a significant technical indicator for contrarian investors, and it is a key component of Sehaeffers' Expectational Analysis® [1][2] - The analysis of short interest helps identify potential stock squeezes, where short sellers may be forced to cover their positions, driving stock prices higher [2][4] Group 1: Short Interest Analysis - The latest analysis by Senior Quantitative Analyst Rocky White focuses on stocks with high short interest, indicating potential for price increases if short sellers capitulate [2][3] - A table compiled by White lists various stocks with their short interest percentages, changes, and average short prices, highlighting significant short interest in the biotechnology sector [4][5] - Biotech stocks are particularly targeted by short sellers due to their volatility and the impact of drug pipeline developments on stock performance [4][6] Group 2: Specific Stock Insights - Insmed Inc (NASDAQ: INSM) has experienced a 9% drop in short interest, with current short interest accounting for 8% of its float, leading to a potential 55% loss for short sellers if they entered at $33.66 [5] - Viking Therapeutics Inc (NASDAQ: VKTX) and TG Therapeutics Inc (NASDAQ: TGTX) also show significant short interest, with 17.1% and 23.4% of their floats sold short, respectively, and potential losses of 55% and 47% for short sellers [5] - The SPDR S&P Biotech ETF (XBI) has seen an increase in short interest from 56% in May 2023 to 64.7% in September 2024, indicating a growing bearish sentiment in the biotech sector [6] Group 3: Future Projections - Projections for 2024 suggest significant potential gains for INSM, VKTX, and TGTX, with expected increases of 141%, 215%, and 30%, respectively, if short sellers begin to cover their positions [7]

Core Viewpoint - Insmed's stock has more than doubled in value over the past six months, significantly outperforming the industry and the S&P 500, driven by advancements in its pipeline candidates, brensocatib and TPIP, targeting various lung disorders [1][2]. Pipeline Development - Brensocatib, the most advanced candidate, was licensed from AstraZeneca in 2016 for treating neutrophil-driven inflammatory conditions [3]. - Positive topline results from the phase III ASPEN study for brensocatib in non-cystic fibrosis bronchiectasis were reported, achieving significant reductions in pulmonary exacerbations compared to placebo [4]. - There are currently no approved medications for bronchiectasis, affecting nearly a million patients in the US, Europe, and Japan [5]. - Insmed plans to submit a regulatory filing for brensocatib in bronchiectasis in Q4 2024, with a potential launch in mid-2025 and in Europe and Japan by H1 2026 [6]. - Brensocatib is also being evaluated in a phase IIb study for chronic rhinosinusitis without nasal polyps, with data expected in H2 2025, and a mid-stage study for hidradenitis suppurativa planned before the end of 2024 [7]. TPIP Development - Insmed is conducting mid-stage studies for TPIP in pulmonary hypertension associated with interstitial lung disease and pulmonary arterial hypertension [7]. - Positive safety and tolerability data from a mid-stage study for TPIP in PH-ILD were reported, indicating potential for prolonged effect and reduced dosing frequency compared to existing therapies [8]. - A majority of patients (79.3%) reached the maximum dose of 640 µg of TPIP after five weeks, which contains nearly 60% more treprostinil than current products [9]. - Insmed plans to initiate a late-stage study for TPIP in PH-ILD next year, with top-line data from the PAH study expected in H2 2025 [9]. Arikayce Development - Insmed reached alignment with the FDA on the primary endpoint of the phase III ENCORE study for Arikayce, targeting newly-infected patients with mycobacterium avium complex lung disease, with top-line data expected in Q1 2026 [10]. - Arikayce is currently the only marketed drug in Insmed's portfolio, approved for refractory MAC lung disease, with a total addressable market estimated at 30,000 patients, potentially increasing to 275,000 if approved for newly-infected patients [12]. - Management anticipates that Arikayce could generate over a billion dollars in peak sales [12]. Financial Position - Insmed's pipeline shows promise compared to other biotech stocks, with a steady income stream from Arikayce sales, reducing pressure on its cash balance of approximately $1.25 billion as of June 2024 [13].

Financial Data and Key Metrics Changes - Insmed ended Q2 2024 with $1.25 billion in cash and cash equivalents, an increase of $651 million compared to the previous quarter, primarily driven by an equity raise that added $713 million on a net basis [20] - Global net revenues for Q2 2024 were $90.3 million, representing a 17% year-over-year growth, marking the highest quarterly sales for ARIKAYCE in its history [21][22] - The underlying cash burn for the quarter was approximately $139 million, consistent with historical trends [20] Business Line Data and Key Metrics Changes - ARIKAYCE delivered 17% growth in Q2 2024 compared to the same quarter last year, with U.S. net revenue at $63.8 million, up 11% year-over-year [14][22] - In Japan, net revenue was $21.1 million, reflecting a 35% growth over the same quarter last year, driven by stronger demand and increased physician reach [22] - In Europe and the rest of the world, net revenue was $5.4 million, up 37% compared to the same quarter last year, primarily driven by strong performance in the UK and Germany [23] Market Data and Key Metrics Changes - The U.S. market saw a rebound in active patients following disruptions caused by a cyber attack earlier in the year, contributing to strong new patient starts for ARIKAYCE [22] - The company is on track to achieve its full-year 2024 global revenue guidance of $340 million to $360 million [23] Company Strategy and Development Direction - The company is focused on the launch of brensocatib in bronchiectasis, with preparations for a U.S. filing expected in Q4 2024 and a launch anticipated in mid-2025 [6][10] - Insmed is also advancing its pipeline with ongoing studies in CRS without nasal polyps and plans for a Phase 2 study of brensocatib in hidradenitis suppurativa [11][12] - The company is developing next-generation DPP1 inhibitors to maintain leadership in this new class of medicines [12][13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the successful launch of brensocatib, emphasizing the importance of payer access and disease state awareness [66] - The ASPEN study results were highlighted as a significant milestone, with management optimistic about the potential impact on patients and the company's future [5][6] - The company acknowledged the competitive landscape but remains focused on executing its strategy effectively [31] Other Important Information - The company reported a noncash charge of approximately $104 million related to the change in fair value of deferred and contingent consideration liabilities, which does not impact cash runway [26] - Insmed's commercial team is preparing for the brensocatib launch by enhancing disease state education and engaging with payers [9][66] Q&A Session Summary Question: Competitive landscape for brensocatib - Management found the BI Phase 2 data presentation disappointing, lacking detailed safety data and clear dose effects, with expectations for more information at the upcoming European Respiratory Society meeting [27][29][30] Question: Primary endpoint for ENCORE study - The primary endpoint for the ENCORE study is a patient-reported outcome measure agreed upon with the FDA, differing slightly from the ARISE study [28] Question: Considerations for NDA filing regarding doses - Management is considering both doses for the NDA, emphasizing the safety profiles and potential benefits of the higher dose [33][35][36] Question: Enrollment status for ENCORE study - Enrollment for the ENCORE study is proceeding well, with expectations to stop screening new patients later in Q3 2024 [15][70] Question: Strategy for targeting patient groups at brensocatib launch - The initial focus will be on the diagnosed population, with plans to raise awareness among physicians about potential misdiagnosed patients [47][49] Question: Pricing strategy for brensocatib - Pricing will reflect the value for money proposition based on clinical data and the expected label, with a range of $40,000 to $96,000 being considered [50][51] Question: ARIKAYCE sales momentum by region - Continued double-digit growth was reported across all regions, with strong performance in the U.S. and Japan [61]

Core Viewpoint - Insmed reported a wider loss per share in Q2 2024 compared to estimates, despite a year-over-year revenue increase driven by its only marketed drug, Arikayce [1][2][3] Financial Performance - Insmed's Q2 2024 loss per share was $1.94, exceeding the Zacks Consensus Estimate of a loss of $1.22, and wider than the previous year's loss of $1.78 [1] - Total revenues for the quarter reached $90.3 million, marking a 17% increase year-over-year, and surpassing the Zacks Consensus Estimate of $88.0 million [1] - Arikayce sales contributed entirely to the revenue, with U.S. sales up 11% to $63.8 million, Japan sales up 35% to $21.1 million, and sales in Europe and the rest of the world up 37% to $5.4 million [2][3] Expenses - Selling, general and administrative (SG&A) expenses rose 26% year-over-year to $106.6 million, primarily due to increased compensation and benefits [4] - Research and development (R&D) expenses decreased by 25% to $146.7 million compared to the previous year, attributed to a non-cash cost recognized in the prior period [4] Cash Position - As of June 30, 2024, Insmed's cash, cash equivalents, and marketable securities totaled $1.2 billion, a significant increase from $595.7 million on March 31, 2024, due to a secondary stock issue that generated net proceeds of $713.2 million [5] Guidance - Management maintained its sales guidance for Arikayce, projecting product sales between $340 million and $360 million for 2024, indicating a 15% year-over-year growth at the midpoint [6] Recent Developments - Insmed aligned with the FDA on the primary endpoint of the phase III ENCORE study for Arikayce, with top-line data expected in Q1 2026 [7] - Positive top-line data from the phase III ASPEN study for brensocatib indicated significant reductions in pulmonary exacerbations, with a regulatory filing expected in Q4 2024 [8] - If approved, brensocatib could be the first treatment for bronchiectasis, with a U.S. launch anticipated in mid-2025 and potential for blockbuster sales [9] - Upcoming data from a mid-stage study on treprostinil palmitil inhalation powder (TPIP) is expected in H2 2025, with plans for a late-stage study next year [10]

Core Insights - Insmed reported $90.34 million in revenue for Q2 2024, a 17% year-over-year increase, and a surprise of +2.71% over the Zacks Consensus Estimate of $87.96 million [1] - The company reported an EPS of -$1.94, which is a decline from -$1.78 a year ago, and a surprise of -59.02% compared to the consensus EPS estimate of -$1.22 [1] Revenue Breakdown - Revenue from Japan was $21.11 million, slightly above the two-analyst average estimate of $21.04 million [3] - Revenue from Europe and the rest of the world was $5.44 million, exceeding the two-analyst average estimate of $4.31 million [4] - Revenue from the U.S. was $63.79 million, surpassing the average estimate of $61.72 million from two analysts [5] Stock Performance - Insmed shares have returned -2.9% over the past month, compared to a -6.5% change in the Zacks S&P 500 composite [5] - The stock currently holds a Zacks Rank 3 (Hold), indicating potential performance in line with the broader market in the near term [5]