Insmed (INSM) Q4 2025 earnings summary

Executive summary

• 2025 marked a transformative year with the U.S. launch of BRINSUPRI, generating $144.6M in Q4 and $172.7M for the year, and European approval secured.

• ARIKAYCE delivered $433.8M in 2025 (+19% YoY), with strong growth in Japan (40% YoY) and Europe, and U.S. revenues at $280.3M.

• Clinical pipeline advanced with TPIP's orphan drug designation for PAH, positive Phase 2 data, and new gene therapies for DMD and ALS entering the clinic.

• Acquired Phase 2-ready INS1148 and discontinued CRS without nasal polyps program.

• 2026 priorities include accelerating BRINSUPRI launch, ARIKAYCE growth, and expanding the pipeline via business development.

Financial highlights

• Full-year 2025 revenues were $606.4M, with BRINSUPRI at $172.7M and ARIKAYCE at $433.8M.

• Q4 2025 U.S. net revenues for BRINSUPRI reached $144.6M, surpassing comparable respiratory launches.

• 2026 revenue guidance: at least $1B for BRINSUPRI, $450–$470M for ARIKAYCE, and total company revenues of at least $1.45B (+139% YoY).

• Cost of product revenues in Q4 2025 was $44.2M (16.8% of revenues), reflecting improved gross margin from BRINSUPRI.

• Cash, cash equivalents, and marketable securities at year-end 2025 totaled ~$1.4B, supporting ongoing investments.

Outlook and guidance

• Confident in achieving cash flow positivity in 2026 without new capital, though funds may be raised for business development.

• BRINSUPRI 2026 revenue guidance of at least $1B, with gross-to-net expected in the mid-20s to low-30s percent range.

• ARIKAYCE 2026 GTN expected in the low to mid-20s percent.

• Continued investment in commercialization, regulatory submissions, and clinical development across the pipeline.

• ENCORE phase III readout for ARIKAYCE expected in March/April, potentially expanding its addressable market from 30,000 to 200,000 patients.