Insmed Incorporated Q2 FY2025 earnings call

Late-stage Portfolio - ARI Kayce: Continues growth, on track for full-year guidance; Phase III ENCORE study readout in H1 2026 for MAC lung disease. - Brensocatib: Near U.S. launch; Europe/U.K./Japan launches in 2026; BiRCh and CEDAR studies ongoing. - TPIP: Phase IIb data in PAH exceeded expectations; on track for Phase III in PH-ILD H2 2025 and PAH early 2026. ### Early-stage Portfolio - Over 30 preclinical programs in active development. - San Diego site initiated Phase I DMD study; New Hampshire site advancing AI-based protein de-immunization; Cambridge site identifying targets for synthetic rescue platform; New Jersey site screening DPP1 inhibitors.

ARI Kayce: Achieved double-digit year-over-year revenue growth globally. U.S. had highest quarterly revenue ever, Japan saw 45% growth, Europe 48% growth. On track to reach 2025 full-year net revenue guidance of $405M to $425M. Brensocatib: Near U.S. launch for non-cystic fibrosis bronchiectasis; launches in Europe, U.K., Japan expected in 2026. Top-line data from BiRCh study in CRS without nasal polyps expected by end 2025, interim futility analysis for CEDAR study in hidradenitis suppurativa in Q1 2026. TPIP: Phase IIb data in PAH exceeded expectations. On track to enter Phase III for PH-ILD in H2 2025 and PAH in early 2026.

• ARI Kayce on track to achieve 2025 full-year net revenue guidance of $405M to $425M. - Brensocatib U.S. launch expected next week, with launches in Europe, U.K., Japan in 2026. - TPIP to enter Phase III for PH-ILD H2 2025 and PAH early 2026. - Expect burn to decrease in coming quarters with brensocatib U.S. launch revenue.

• Clinical trial results may not meet expectations. - Launch challenges for new indications, including patient access and payer interactions. - Uncertainties in regulatory approvals and market adoption.

Q: Ahead of brensocatib launch, what's being done to capture patients?

A: Will Lewis mentioned prior experience with ARI Kayce, early field deployment, patient support programs like inLighten, and partnerships with care centers.

Q: Optimism on capturing additional asthma/COPD patients?

A: Will Lewis noted potential to engage patients with comorbidities through disease state awareness and CT scans.

Q: Interim futility analysis for brensocatib in HS?

A: Martina Flammer explained futility analysis focuses on primary endpoint for HS, looking for efficacy signal.

Q: Next-generation DPP1 molecules?

A: Will Lewis discussed potential in various indications like COPD, asthma, rheumatoid arthritis, with animal models supporting clinic entry.

Q: Market access for brensocatib?

A: Roger Adsett mentioned positive payer discussions, focus on frictionless launch and reauthorization.

Q: TPIP and competitor trial in IPF?

A: Martina Flammer said TPIP's profile is strong, will watch TETON study results and engage with FDA on Phase III plans.

Q: DMD gene therapy trial?

A: Will Lewis and Martina Flammer discussed intrathecal delivery benefits, cautious approach, and no weight-based dosing in the study.