Core Insights - Insmed Incorporated reported unaudited total revenues of approximately $144.6 million for the first full quarter of the launch of BRINSUPRI and approximately $172.7 million for full-year 2025 [1] - ARIKAYCE exceeded the upper end of guidance for full-year 2025 with unaudited global revenues of approximately $433.8 million, with expectations for 2026 revenues between $450 million and $470 million [1][3] - The company anticipates topline data from the Phase 3 ENCORE study of ARIKAYCE in patients with MAC lung disease in March or April of 2026, and topline data from the Phase 2b CEDAR study of Brensocatib in the second quarter of 2026 [1][10] Financial Performance - Preliminary unaudited financial results for full-year 2025 show ARIKAYCE revenues of $433.8 million, a 19% increase from $363.7 million in 2024, with U.S. revenues growing by 10% and international revenues by 41% [3][4] - BRINSUPRI generated total revenues of $172.7 million in the U.S. for 2025, marking its first full year of launch [3][4] - Total revenues for Insmed in 2025 are expected to reach approximately $606.4 million, a 67% increase from $363.7 million in 2024 [4] Clinical Developments - Insmed plans to launch BRINSUPRI in the European Union in the first half of 2026, following its approval for treating non-cystic fibrosis bronchiectasis [10] - The company initiated the Phase 3 PALM-ILD study of TPIP in patients with pulmonary hypertension associated with interstitial lung disease in Q4 2025, with additional Phase 3 studies planned for PAH, PPF, and IPF in 2026 [10] - Insmed acquired INS1148, a Phase 2-ready monoclonal antibody, and plans to advance its development in interstitial lung disease and asthma [9][10] Market Position and Strategy - Insmed emphasizes its commitment to delivering first- and best-in-class therapies, with a focus on serious diseases across therapeutic areas including Respiratory, Immunology & Inflammation, and Neuro & Other Rare [2] - The company has a diverse portfolio of approved and investigational medicines, with ongoing research in gene therapy and other innovative technologies [56][57] - Insmed's CEO highlighted the potential for significant growth in the next 18 months due to upcoming clinical and commercial catalysts [2]
Insmed Provides Business Update at 44th Annual J.P. Morgan Healthcare Conference