Insmed's Q4 2024: Key Contradictions in Brenso's Market Access, Gross to Net Expectations, and Dosing Strategy

These are the key contradictions discussed in Insmed's latest 2024Q4 earnings call, specifically including: Brenso's Gross to Net Expectations and the Impact of the IRA, Market Access Strategy for Brenso, and Brenso's Dosing Regimen:



Brensocatib in Bronchiectasis and Market Access Strategy:
- Insmed announced the FDA acceptance of the NDA filing for brensocatib in bronchiectasis under priority review with a PDUFA date of August 12, 2025.
- The company anticipates that brensocatib's pricing in the U.S. will be in the upper half of the $40,000 to $96,000 range at launch, following extensive pricing work that considered actual clinical data and feedback.
- The strategy focuses on a multifaceted market access approach to ensure a simple and straightforward prior authorization process, prioritizing verbal attestation and reauthorization to maintain patient access.

Commercial Performance and Revenue Growth:
- Global net revenue for 2024 was $363.7 million, reflecting 19% year-over-year growth and exceeding the top end of guidance, driven by strong performance of ARIKAYCE with 19% year-over-year growth in new patient starts and treatment continuation rate.
- U.S. net revenue for 2024 was $254.8 million, up 14% compared to 2023, and Japan's net revenue was $87.7 million, up 33%.
- The growth was supported by strong execution by commercial teams and new patient starts, particularly in Japan and Europe.

bronchiectasis and CRS without Nasal Polyps:
- There are about 50% of diagnosed bronchiectasis patients in the U.S. with two or more exacerbations, with the potential addressable market for brensocatib in bronchiectasis being much larger due to patients with comorbidities like COPD and asthma.
- The BiRCh Phase 2 trial for brensocatib in CRS without nasal polyps focuses on steroid non-responders and those who have undergone surgery, aiming for a primary endpoint reduction in the sinus total symptom score by 0.9 units.

TPIP and Prostacyclin Class:
- The Phase 2 PAH data readout for TPIP is expected to demonstrate reductions in pulmonary vascular resistance (PVR) as a primary endpoint, aiming to exceed reductions seen in other prostacyclin class assets.
- The trial is powered to show a difference of 0.9 units in the sinus total symptom score, with an alpha level of 0.1, focusing on the effect of brensocatib on top of nasal steroids.