Madrigal Pharmaceuticals posts $311m Rezdiffra Q1 sales, up 127%
Madrigal Pharmaceuticals reported first-quarter 2026 net revenues of $311.3 million from Rezdiffra (resmetirom), a 127% year-on-year increase from $137.3 million in the same period of 2025. The Pennsylvania-based biopharmaceutical company said more than 42,250 patients were on Rezdiffra as of 31 March 2026, a 2.5-fold increase compared to the first quarter of 2025, reflecting what the company characterises as broad physician adoption across the MASH treatment landscape.
Chief executive Bill Sibold said Rezdiffra had achieved "blockbuster status" on a trailing-12-month net sales basis — a reference to the pharmaceutical industry's conventional $1 billion annual revenue threshold. Sibold pointed to a patient pool the company estimates has grown by nearly 50% in two years, reaching approximately 460,000 diagnosed patients with moderate to advanced fibrosis.
Pipeline expansion
Alongside the revenue figures, Madrigal disclosed a licensing agreement with Arrowhead Pharmaceuticals for global rights to ARO-PNPLA3, a GalNAc-conjugated small interfering RNA designed to silence PNPLA3, a genetically validated driver of MASH. The deal was announced on 5 May. The PNPLA3 I148M variant is highly prevalent in Hispanic populations and is estimated to account for approximately 30% of patients with moderate to advanced fibrosis. Phase 1 data showed a single dose at the highest level tested produced up to a 46% reduction in liver fat — measured by MRI-PDFF — at 12 weeks in homozygous carriers.
Madrigal also holds global rights to six preclinical siRNA programmes licensed in February 2026, positioning the company to pursue combination strategies pairing genetically targeted silencing with resmetirom's thyroid hormone receptor beta agonism. MGL-2086, an oral GLP-1 candidate, is on track to enter a Phase 1 trial in the second quarter of 2026, while an ervogastat–resmetirom drug-drug interaction study is scheduled for the fourth quarter.
Market context and competitive landscape
Rezdiffra remains the only MASH therapy approved by both the FDA and the European Commission for patients with moderate to advanced fibrosis (F2–F3), giving Madrigal a first-mover advantage in what has been one of the most actively contested development spaces in hepatology. A Phase 3 outcomes trial evaluating resmetirom in compensated MASH cirrhosis (F4c) is ongoing, which could substantially widen the addressable indication if successful.
The MASH field nonetheless carries meaningful competitive risk. Several large-cap players, including Novo Nordisk and Eli Lilly, are examining GLP-1 receptor agonists — the dominant obesity drug class — for hepatic endpoints, while purpose-built liver-directed programmes from other biotechs remain in mid- to late-stage development. Madrigal's strategy of layering siRNA combination assets on to an approved backbone is a credible defensive move, though the durability of that lead will depend on combination trial data that are not yet available.
On the financial side, total operating expenses reached $404.1 million in the quarter, including $54.3 million in one-time upfront business development costs tied to the pipeline licensing activity, and $268.5 million in SG&A as the company scaled its endocrinology field force and launched a direct-to-consumer advertising campaign. The resulting net loss was $94.4 million, or $3.25 per share. Cash, cash equivalents and marketable securities stood at $817.9 million at quarter-end, down from $988.6 million at the close of 2025, reflecting the licensing outlays and operating burn.
Madrigal will present eight abstracts at the EASL Congress in Barcelona from 27–30 May 2026, including real-world Rezdiffra efficacy data at up to one year of treatment and a secondary analysis showing reductions in Lp(a) and LDL-C, a finding the company says supports a cardiovascular risk-reduction benefit independent of statin use.