Brinsupri Launch and 2026 Revenue Guidance
Brinsupri received approval and delivered $144,600,000 in net revenue in its first full quarter. About 11,550 new patients started Brinsupri in 2025 (reported as <5% penetration of the initial target patient cohort). Management provided 2026 revenue guidance of at least $1,000,000,000 for Brinsupri and expects total company revenue in 2026 to be more than double 2025 levels. Gross-to-net for Brinsupri is guided to mid-20s to low-30s percent in 2026, with 2025 GTN already in that range.
ARIKAYCE Commercial Momentum and Potential Label Expansion
ARIKAYCE showed robust global growth: Japan delivered ~40% growth versus 2024 and accounted for >25% of ARIKAYCE global revenues; Europe grew faster (from a smaller base). The Phase III ENCORE readout is expected in March/April 2026 and, if successful, could expand ARIKAYCE's addressable market from ~30,000 patients to >200,000 patients.
Strong Cash Position and Path to Cash Flow Positivity
Insmed ended 2025 with approximately $1,400,000,000 in cash, cash equivalents, and marketable securities. Management expects to achieve cash flow positivity based on existing plans without needing to raise additional capital (while retaining flexibility to source capital for business development or pipeline expansion).
TPIP Progress and Orphan Drug Designation
TPIP (treprostinil palmitil) was significantly de-risked by 2025 clinical data and the FDA granted orphan drug designation for PAH, citing plausible clinical superiority. A Phase III registrational trial design has been presented and the company expects to initiate the PAH Phase III in H1 2026; FDA indicated one well-designed Phase III could support filing.
Favorable Market Access and High Payer Approval Rates
Management reported that over 90% of targeted patient lives have access to Brinsupri (GETRA/SUPRI) reimbursed via documented payer policy or medical exception. They noted very high payer approval rates so far, even among plans requiring documentation (CT scan and proof of ≥2 exacerbations), and indicated many payers are adopting attestation-based prior authorization with modest rebates.
Pipeline and Business Development Expansion
Insmed completed the acquisition of INS1148 (one-time cash impact noted) and reported entering two new gene therapies into the clinic (DMD and ALS). Management reiterated intent to pursue additional first-or-best-in-class assets (including further DPP1 candidates) and noted selective BD as a strategic priority.
Improved Product Margin Profile
Cost of product revenues for 2025 was $44,200,000, or 16.8% of revenues, a lower percentage relative to historical performance attributed to Brinsupri contributions, indicating a favorable impact on gross margin.