Insmed(US:INSM) Prnewswire·2025-01-10 13:00Core Insights - Insmed Incorporated reported unaudited global revenues of approximately $363.7 million for ARIKAYCE in 2024, exceeding the upper end of guidance, representing a 19% year-over-year growth compared to 2023 [1][3] - The company anticipates global ARIKAYCE revenues for 2025 to be between $405 million and $425 million, indicating continued double-digit growth [1][6] - Insmed submitted a New Drug Application (NDA) for brensocatib in bronchiectasis to the FDA in December 2024, with a potential U.S. launch expected in the third quarter of 2025, pending approval [1][6] - Enrollment for the Phase 2 study of TPIP in patients with pulmonary arterial hypertension (PAH) was completed in December 2024, with topline data expected in mid-2025 [1][6] - The Phase 3 ENCORE trial for ARIKAYCE in patients with newly diagnosed or recurrent Mycobacterium avium complex (MAC) lung disease is fully enrolled, with topline data anticipated in the first quarter of 2026 [1][6] - The FDA cleared the Investigational New Drug (IND) application for Insmed's first gene therapy (INS1201) for patients with Duchenne muscular dystrophy (DMD), with the first patient dosing expected in the first half of 2025 [1][6] Financial Performance - Preliminary unaudited global net product sales of ARIKAYCE for 2024 are approximately $363.7 million, with regional breakdowns showing the U.S. at $254.8 million (14% growth), Japan at $87.7 million (33% growth), and Europe at $21.2 million (39% growth) [3] - The company expects to report final fourth-quarter and full-year 2024 financial results in late February 2025 [3] Clinical Development Updates - The ENCORE trial for ARIKAYCE has exceeded its target enrollment of 400 patients, reaching a total of 425 patients [6] - The Phase 2b BiRCh trial of brensocatib in patients with chronic rhinosinusitis without nasal polyps (CRSsNP) has completed nearly 70% of its target enrollment, with topline data expected before the end of 2025 [6] - The company plans to initiate a Phase 3 study in PH-ILD in the second half of 2025 [6] Future Outlook - Insmed's CEO, Will Lewis, expressed optimism about the company's potential to expand its patient reach from approximately 30,000 today to over 2.5 million by the end of the decade, driven by upcoming clinical and commercial catalysts [2] - The company continues to expect double-digit growth for ARIKAYCE while awaiting the readout of ENCORE data, which could unlock significant opportunities for the brand [2]