Ritu Baral

Baral asked about compliance initiatives behind improved fill rates; Lewis said the medicine's own efficacy drives persistence, reinforced by education.

Management said both matter but emphasized depth as the bigger opportunity. Noted 1,800 single-prescription writers in Q4, half of whom wrote additional prescriptions in Q1. Positive patient feedback is the key driver.

CEO emphasized market access ahead of internal expectations. Documentation requirements were always expected for some plans; field access managers deployed to support back office navigation. Noted only 1 full quarter of data exists so early to refine upward from $1B floor. Will provide more qualitative guidance through the year.

CEO outlined clear, non-burdensome criteria: physician attestation of 2+ exacerbations and confirmed bronchiectasis diagnosis. Willing to do modest discounting to achieve frictionless access. COO confirmed engaging with payers representing ~90% of targeted lives at national and regional levels.

COO described strategy for physician attestation for CT diagnosis and 2+ exacerbations. No free drug sampling planned. Patient copay support available for commercial patients.

No mid-cycle review surprises. CEO not concerned about PVR/6MWT divergence given known prostanoid class mechanism. Shared anecdote of patient with broken leg skewing 6MWT.

Detailed breakdown of ARIKAYCE vs brensocatib IRA treatment. Brensocatib faces full 20% catastrophic coverage immediately. ~60% Medicare patient mix drives 12% gross-to-net just from IRA.

Management explained prodrug chemistry reduces cough burden. Low discontinuation rates in PAH study. Scientific advisory group encouraged doubling max dose to 1,280 mcg.

Management explained that early second-line use normalizes as stabilizer patients transition, while physician experience drives increasing first-line adoption. Provided clear framework for prescriber evolution.

CFO confirmed mid-single-digit net price decrease for 2026, gradual over the year rather than front-loaded. Management declined to comment on 2027 pricing specifics but noted 2030 CAGR goal of 25% incorporates competitive dynamics.

Management said European CM launch requires limited incremental investment since PN team already covers centers of excellence. Japan more fragmented requiring additional investment.

Management confirmed no payer distinctions by genotype. Step edits are single-digit commercial only with no time limits. CMO emphasized HELIOS-B benefits across all variants and severities.

Management said physicians are putting both newly diagnosed and progressing patients on AMVUTTRA first-line based on clinical profile. Clarified Medicare fee-for-service has no prior auth.

Management emphasized 10/10 prespecified endpoint results and differentiated product profile but deferred to standard labeling conventions rather than confirming specific label language.