The biopharmaceutical company focuses on developing therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease. Its primary product, Rezdiffra (resmetirom), is a once-daily oral medication targeting the underlying causes of MASH. Rezdiffra received accelerated approval from the FDA in March 2024 and became commercially available in April 2024. It is specifically indicated for adults with noncirrhotic MASH with moderate to advanced liver fibrosis.
The company generates revenue primarily through the sale of Rezdiffra, supported by clinical trial data that demonstrated significant improvements in MASH resolution and fibrosis. The company is conducting ongoing trials to gather confirmatory data for full approval and to expand Rezdiffra's indications. The primary customers include healthcare providers and patients dealing with MASH. The company plans to expand its market presence into Europe, with a marketing authorization application under evaluation by the European Medicines Agency.
The company operates with divisions in research, development, medical affairs, commercial activities, and general administration. It relies on third-party contract manufacturers for the production of Rezdiffra and maintains supply agreements for commercial distribution. Key factors impacting business performance include the competitive landscape with over 150 drugs in development for MASH, regulatory approvals, and the ability to secure coverage and reimbursement from third-party payors. The company leverages its first-to-market position to establish a strong market presence.