Financial Performance & Guidance - BRINSUPRI achieved preliminary unaudited U S net revenues of approximately $144 6 million in Q4 2025 and $172 7 million for the full year 2025[23] - ARIKAYCE generated worldwide revenue of approximately $433 8 million in FY 2025, representing a 19 3% increase year-over-year[27] - The company anticipates ARIKAYCE revenue to be between $450 million and $470 million for the full year 2026[28] Clinical Development Programs - The company expects topline data readout from the Phase 3 ENCORE trial for ARIKAYCE in March/April 2026, potentially leading to label expansion[30, 31] - Phase 3 trials for TPIP in PAH, PPF, and IPF are expected to initiate in early and the second half of 2026 respectively[13, 38] - Topline data readout from the Phase 2 CEDAR trial for brensocatib in Hidradenitis Suppurativa is expected in Q2 2026[46, 50] Pipeline Expansion - The company plans to file Investigational New Drug (IND) applications for RA and IBD in the second half of 2026[13, 50] - IND filing for Stargardt is anticipated in 2026[13, 59] - Phase 2 programs in ILD and moderate to severe asthma are planned for INS1148[13, 40] Commercial Expansion - BRINSUPRI is expected to launch in the EU and UK, pending regulatory approval[13, 44] - BRINSUPRI is also anticipated to launch in Japan, pending regulatory approval[13, 44] Cash Position - The company reported a cash position of $1 7 billion as of September 30, 2025[62]
Insmed (NasdaqGS:INSM) FY Earnings Call Presentation