Insmed (INSM) investor relations material

Key business and launch updates

• Q4 revenue reached $144 million, significantly exceeding consensus estimates, with over 9,000 patients initiated by more than 4,000 physicians.

• Launch momentum remains strong, with no evidence of a one-time bolus; patient and physician experiences are driving ongoing uptake.

• Half of prescribing physicians have written only one prescription, indicating potential for increased depth as positive patient feedback circulates.

• Market access is expanding, with insurance policies aligning to target patients with two or more exacerbations, supporting continued growth.

• Gross-to-net guidance is 25% to low 30s, reflecting modest discounts to shape payer policies and ease prior authorization requirements.

Forward-looking statements and growth drivers

• Peak sales estimate exceeds $5 billion based on 250,000 diagnosed patients with two or more exacerbations; broader populations could multiply this opportunity.

• Expansion into patients with zero to one exacerbation and undiagnosed comorbid COPD/asthma populations is a future growth lever.

• Ex-U.S. launches are on hold pending MFN policy clarity, with Europe and Japan poised for future contributions.

• Positive patient experiences and peer-to-peer physician dialogue are expected to drive both depth and breadth of prescribing.

• No anticipated slowdown from new insurance policies; infrastructure and experience from prior launches support ongoing access.

Pipeline and competitive landscape

• TPIP for PAH remains differentiated as a once-daily inhaled therapy with best-in-class PVR reduction and a favorable safety profile.

• Open label extension data for TPIP, including higher dose cohorts, expected by year-end, with potential for increased efficacy without added adverse events.

• ENCORE phase III data for ARIKAYCE could expand TAM from 30,000 to over 200,000 patients if positive, with key endpoints including PROs and culture conversion durability.

• Durable culture conversion and significant delta versus standard of care are critical for frontline adoption.

• FDA is supportive of expanding ARIKAYCE into frontline use, viewing it as a success story.