Global Healthcare Biopharma catalysts to watch in 3Q25 With macroeconomic volatility and healthcare policy uncertainty persisting likely into the back half of the year, we continue to advocate for and highlight idiosyncratic catalysts with attractive risk/reward setups to drive alpha generation. Herein, we highlight and preview key catalysts in 3Q25 across the GS biotechnology coverage universe from pivotal studies: BMY's Cobenfy ADEPT-2 in Alzheimer's disease psychosis; LLY's orforglipron ATTAIN-1 in obesi ...

Core Insights - Insmed Inc experienced a significant stock surge of 45% in the last month, driven by successful Phase IIb trial results for its inhalation therapy TPIP in pulmonary arterial hypertension (PAH) [2] - The company is currently trading at a high valuation of 35 times sales, which translates to a low sales yield of 2.8%, raising concerns about its sustainability [3] - Insmed's stock premium is primarily attributed to the positive trial results and a $750 million capital raise aimed at pipeline expansion, leading to investor optimism [4][5] Financial Performance - Insmed projects global revenues for its product ARIKAYCE to be between $405 million and $425 million in 2025, indicating an 11-17% growth compared to 2024 [6] - The company is expected to remain unprofitable into 2026 due to ongoing investments in research and development for pipeline products [6] Future Outlook - The FDA's decision on brensocatib in August and the initiation of Phase 3 trials for TPIP are critical upcoming milestones that could significantly impact Insmed's stock performance [7] - Successful execution of Phase 3 trials and commercial launches of both brensocatib and TPIP will be essential for maintaining the current premium valuation [7][8]

10 June 2025 | 4:36PM EDT Insmed Inc. (INSM): Positive Ph2b TPIP PAH data surpass expectations INSM reported positive topline data from the Ph2b TPIP PAH trial with the study meeting all primary and secondary efficacy endpoints. Notably, TPIP treatment (measured 24 hours at trough, and thereby supportive of once daily dosing) resulted in 35% placebo-adjusted reduction from baseline in PVR (p<0.001) and 35.5m placebo-adjusted improvement in 6MWT (p=0.003), consistent with our bull case scenario and driving s ...

Insmed (INSM) Update / Briefing June 10, 2025 08:00 AM ET Speaker0 Thank you for standing by, and welcome to the Insmed Phase 2b PAH Top Line Results Conference Call. All lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question and answer Thank you. I'd now like to turn the call over to Brian Dunn, Head of Investor Relations. You may begin. Speaker1 Thank you, Rob. Good day, everyone, and welcome to today's conference call to discuss the top line ...

Core Insights - Insmed Incorporated presented 11 new abstracts at the ATS 2025 International Conference, highlighting the efficacy and safety of brensocatib in treating non-cystic fibrosis bronchiectasis [1][3] - The ASPEN trial demonstrated consistent efficacy across various patient subgroups, reinforcing brensocatib's potential as a foundational treatment for bronchiectasis [2][3] Group 1: Brensocatib and ASPEN Trial Findings - Brensocatib showed a reduction in pulmonary exacerbations and prolonged time to first exacerbation compared to placebo, with a similar safety profile [3][5] - In adolescents aged 12 and older, brensocatib reduced annualized exacerbation rates significantly, with 59% of patients remaining exacerbation-free compared to 35% on placebo [5] - The trial included 391 active sites across 35 countries, with a total of 1,680 adult patients and 41 adolescent patients participating [5][6] Group 2: Additional Research and Data - Insmed presented a post-hoc analysis on the healthcare burden of bronchiectasis and findings from an expanded Phase 2 analysis of TPIP for pulmonary hypertension associated with interstitial lung disease [4] - Real-world outcomes for ARIKAYCE treatment were also shared, demonstrating longitudinal health status improvements in patients with refractory Mycobacterium avium complex lung disease [4] Group 3: Company Overview and Commitment - Insmed is focused on delivering first- and best-in-class therapies for serious diseases, with a diverse portfolio of approved and investigational medicines [29][30] - The company emphasizes its commitment to advancing research that can transform care for patients with serious diseases [3][29]

Insmed (INSM) 2025 Conference May 13, 2025 05:20 PM ET Speaker0 Five Healthcare Conference in Las Vegas. My name is Jason Zemanski. I'm one of the SMID cap analysts here at the bank. Joining me on stage is my associate Cameron Bozdag, and I'm very pleased to be sharing the stage here with Will Lewis, chair and CEO of Insmed. Thank you for joining us. Thank you for having me. Absolutely. So a lot to talk about, but I think most investors right now are concentrated on a phase two asset of yours, TPIP. PAH dat ...

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) 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 ...