Insmed (INSM) Status Update summary

Commercial transformation and market expansion

• Addressable patient population is expected to grow from 30,000 to over 2.5 million by 2030, a 90-fold increase, driven by new indications for ARIKAYCE, TPIP, and brensocatib.

• Each program—TPIP, ARIKAYCE, and brensocatib—has positive clinical data and represents blockbuster or multi-blockbuster potential, with little or no competition in the closest-to-market indications.

• Combined peak sales potential for these programs is projected to exceed $8 billion, with brensocatib alone expected to reach $5 billion in bronchiectasis.

• All three therapies have potential to be first- or best-in-disease if approved, targeting multiple indications including pulmonary hypertension, MAC lung disease, bronchiectasis, CRSSNP, and HS.

• Addressable patient population growth is supported by a steady cadence of launches across indications.

Clinical and commercial updates by asset

• TPIP targets PH-ILD (~135,000 patients) and PAH (~90,000 patients) with a once-daily inhaled formulation, showing positive safety and efficacy signals and aiming for superior convenience and safety.

• ARIKAYCE is approved for refractory MAC NTM, with potential to expand to all MAC LD (up to 275,000 patients globally), and 2024 revenue guidance of $340–$360 million.

• Brensocatib’s ASPEN study exceeded expectations, showing significant reductions in pulmonary exacerbations and lung function decline, with a safety profile comparable to placebo.

• Brensocatib targets bronchiectasis (>1 million patients at launch), CRSSNP, and HS, with a U.S. addressable population estimated at 500,000 diagnosed patients and additional upside from undiagnosed cases.

• Phase 2 HS trial initiation for brensocatib is expected by year-end, targeting over 600,000 patients globally.

Launch readiness and infrastructure

• Deep relationships with prescribers and advocacy groups established through ARIKAYCE will accelerate brensocatib’s launch.

• U.S. field team expansion underway, with 120+ new sales roles to supplement the existing team, aiming for full deployment by Q4.

• Similar launch preparations planned for EU and Japan, leveraging established infrastructure and strong regional networks.

• Payer education and engagement began early, with over 70 payer accounts covering 85% of U.S. patient lives already contacted; >85% payer coverage for Medicare and commercial lives.

• Disease education and digital engagement are well underway to support commercial execution.