Commercial Launch Challenges: Despite FDA approval for resmetirom, successful market penetration, physician adoption, and patient adherence are not guaranteed, potentially impacting revenue targets.

Reimbursement & Payer Coverage Hurdles: Securing broad, favorable, and timely reimbursement from commercial and government payers for resmetirom is crucial for sales volume and can be a lengthy and uncertain process.

Intense Competitive Landscape: Madrigal faces significant current and future competition in the MASH therapeutic area from companies developing alternative treatments, which could limit market share and pricing flexibility.