Insmed Incorporated Q3 FY2025 earnings call

Commercial Highlights

• BRINSUPRI launched in the U.S. with ~2,550 new patients started and ~1,700 physicians writing scripts in the first partial quarter. Early feedback from physicians is positive, with enthusiasm for the medicine's potential. Market access is improving but payers haven't finalized criteria yet.
• Europe's CHMP recommended approval of brensocatib for non-cystic fibrosis bronchiectasis, with EMA decision expected by end 2025. U.K. filing for brensocatib progresses, and Japan filing accepted with potential launch in second half 2026.

Clinical Highlights

• BiRCh trial of brensocatib in CRS without nasal polyps on track for completion by end 2025, top line results expected early Jan 2026. CEDAR trial in hidradenitis suppurativa fully enrolled, top line readout expected in first half 2026.
• TPIP Phase III program planned, with PALM-ILD trial on track to open sites end 2025. ARIKAYCE's Phase III ENCORE trial progressing, could expand label to include more patients with NTM MAC lung disease.
• Gene therapy programs for DMD and ALS making progress, next-gen DPP1 candidates to enter clinic in 2026.

BRINSUPRI achieved $28 million in net sales in its first partial quarter of launch. ARIKAYCE posted its largest quarter of revenue ever, up 22% year-over-year, with U.S. growth at 11% and international (Japan and Europe) growth over 50%. BRINSUPRI contributed positively to the company's gross margin profile, with cost of product revenues at $29.4 million or 20.6% of revenues in Q3 2025.

• Raised 2025 full year global ARIKAYCE net revenue guidance to $420M-$430M from $405M-$425M. - BRINSUPRI's first full quarter (Q4 2025) will provide more insight into launch progress, including deeper prescribing patterns and market access clarity.

• Launch dynamics can change as the launch progresses, including market access and reimbursement criteria. - Clinical trial results may differ from interim observations, especially in early-stage studies like BiRCh and CEDAR.

Q: Congrats on the launch. Curious about early feedback from the field on physician experience with BRINSUPRI and reimbursement.

A: William Lewis and Roger Adsett discussed positive feedback from physicians, with enthusiasm for the medicine's potential. Market access is improving but payers haven't finalized criteria yet.

Q: TPIP Phase III design and overcoming orphan drug exclusivity.

A: Martina Flammer discussed TPIP's design and potential to overcome orphan exclusivity through efficacy, safety, and patient care impact.

Q: BiRCh study details on control arm TSS reduction and baseline characteristics.

A: Martina Flammer provided details on BiRCh's placebo assumptions, baseline sTSS scores, and eosinophil analysis.