What Madrigal Pharmaceuticals, Inc. told the SEC could break it.

Madrigal distributes Rezdiffra in the U.S. through only a limited number of specialty pharmacies that account for substantially all of its U.S. revenue; multiple individual customers exceeded 10% of gross product revenue.

“These specialty pharmacies account for substantially all of our revenue in the U.S.”

Madrigal's entire product revenue (~$958.4M in 2025) comes from a single drug, Rezdiffra; any safety, competitive (generics) or commercial setback for Rezdiffra would threaten the whole business.

“For the year ended December 31, 2025, we generated $958.4 million in product revenue from sales of Rezdiffra.”

Madrigal's European commercialization of Rezdiffra (launched in Germany Sept 2025) depends on pricing and reimbursement terms set country-by-country at the EU Member-State level, with widely varying requirements.

“Pricing and reimbursement decisions are made at the Member State level in the EU and the policies, evidentiary requirements, and assessment methodologies governing drug pricing and reimbursement vary widely from country to country.”

Madrigal owns no manufacturing facilities and relies entirely on third-party manufacturers for both clinical and commercial supply of Rezdiffra.

“we currently rely, and expect to rely on third-party manufacturers to supply our product candidates for our clinical trials as well as our commercial supply of Rezdiffra.”