Madrigal's Rezdiffra Growth Cools After a 127% First Quarter
Second-quarter net sales reached $364.3 million as more than 49,000 patients were on the MASH drug.
Madrigal Pharmaceuticals (MDGL), a biopharmaceutical company focused on metabolic dysfunction-associated steatohepatitis, reported Rezdiffra net sales of $364.3 million in the second quarter of 2026, up 71% from $212.8 million a year earlier. That year-over-year rate slowed from the 127% increase recorded in the first quarter, when sales were $311.3 million. Sequential sales still rose from that first-quarter level.
The increase versus the year-ago period was driven by higher demand for Rezdiffra in the United States in 2026. Chief Executive Officer Bill Sibold said Rezdiffra had already achieved nearly $1.3 billion in trailing-12-month net sales. In the first quarter, Rezdiffra had achieved blockbuster status on a trailing-12-month sales basis.
As of June 30, 2026, more than 49,000 patients were on Rezdiffra, more than doubling from the second quarter of 2025. That count followed more than 42,250 patients as of March 31, 2026, and more than 36,250 at year-end 2025. Sibold said the company surpassed 50,000 active patients earlier in July.
Operating expenses were $420.6 million in the second quarter, including $35.4 million of non-cash stock-based compensation, versus $260.0 million a year earlier. Cost of sales was $40.0 million, compared with $9.1 million in the year-ago quarter. The increase was primarily driven by higher royalties payable to Roche on Rezdiffra sales and a write-down of certain work-in-process inventory. Research and development expenses were $91.2 million, versus $54.1 million a year earlier, primarily due to one-time upfront business development expenses of $25.0 million. Selling, general and administrative expenses were $289.4 million, versus $196.9 million a year earlier, primarily due to continued commercial investment in Rezdiffra, including endocrinology field-force headcount that began in the fourth quarter of 2025 and a direct-to-consumer campaign.
Net loss was $57.9 million, or $1.99 a share, compared with a net loss of $42.3 million, or $1.50 a share, a year earlier. The second-quarter loss included $25.0 million, or $0.86 a share, in one-time upfront business development expenses. Cash, cash equivalents, restricted cash and marketable securities were $838.9 million as of June 30, 2026, compared with $988.6 million as of Dec. 31, 2025.
The company issued three new resmetirom patents. Two Orange Book-listed patents cover the FDA-approved label: one directed to a weight-threshold step-down 60 mg or 80 mg dose for F2-F3 MASH patients also using a moderate CYP2C8 inhibitor, expected to provide protection into 2045, and one directed to administration of rosuvastatin with resmetirom at a maximum of 20 mg per day, expected to protect into 2042. A third patent covers a method of administering resmetirom to treat well-compensated cirrhosis (F4c), also expected to protect into 2042.
In June 2026, Madrigal initiated dosing in a Phase 1 single-ascending-dose trial of MGL-2086, an oral GLP-1 receptor agonist and orforglipron derivative, as the first step of a Rezdiffra/MGL-2086 combination program in MASH. The first-quarter update had said the trial was on track to initiate in the second quarter. Combining Rezdiffra with MGL-2086 offers potential for a once-daily combination, based on Phase 3 MAESTRO-NASH data showing that even modest weight loss of at least 5% has the potential to enhance Rezdiffra’s antifibrotic efficacy.
At the May EASL Congress, the company presented real-world data showing that over a mean follow-up of approximately nine months, nearly 50% of patients treated with Rezdiffra achieved at least a 25% improvement in liver stiffness. It also presented an ANTICIPATE-NASH risk-stratification analysis of MAESTRO-NAFLD-1 open-label F4c results in which the proportion of patients classified as higher risk for clinically significant portal hypertension decreased from 75% at baseline to 54.5% at Year 2. A secondary analysis from Phase 3 MAESTRO-NASH and MAESTRO-NAFLD-1 trials showed Rezdiffra significantly reduced multiple atherogenic lipoproteins, including LDL and Lp(a), regardless of baseline statin use. An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for compensated MASH cirrhosis.
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