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Earnings

Madrigal Turns Profitable as Rezdiffra Hits Blockbuster Sales

Rezdiffra net sales were $431.3 million in the third quarter, and the company posted net income of $55.4 million, or $1.90 a basic share and $1.83 a diluted share, after a year-earlier loss.

Madrigal Pharmaceuticals (MDGL), a biopharmaceutical company focused on metabolic dysfunction-associated steatohepatitis, reported third-quarter 2026 net revenues of $431.3 million, up 50% from $287.3 million a year earlier, and achieved its first quarter of profitability.

The company recorded net income of $55.4 million, or $1.90 a basic share and $1.83 a diluted share, compared with a net loss of $114.2 million, or $4.01 a share, in the year-ago quarter.

Year-over-year Rezdiffra growth slowed from 71% in the second quarter and 127% in the first quarter. Sequential sales still rose from $364.3 million in the second quarter. For the nine months ended Sept. 30, 2026, Rezdiffra net sales reached $1.1 billion, which the company said marked blockbuster status less than three years after launch.

Chief Executive Officer Bill Sibold said the quarter was driven by continued Rezdiffra demand, deeper prescriber adoption and accelerating market growth, and that the company was still early in a rapidly growing market.

As of Sept. 30, 2026, more than 55,850 patients were on Rezdiffra, nearly doubling from the third quarter of 2025. That followed more than 49,000 patients as of June 30 and more than 42,250 as of March 31.

The company said the U.S. F2-F3 MASH addressable market had grown to more than 530,000 patients through June 30, 2026, and that it is on track for more than 30% growth by year-end 2026.

Operating expenses were $375.3 million, including $38.9 million of non-cash stock-based compensation, compared with $401.2 million, including $26.3 million of stock-based compensation, a year earlier. Cost of sales was $37.8 million, up from $18.1 million, which the company attributed primarily to higher Roche royalties on increased Rezdiffra sales.

Research and development expenses were $71.8 million, down from $174.0 million a year earlier. The company said the decline was primarily due to a one-time $117.3 million upfront business-development expense in the comparable prior-year period.

Selling, general and administrative expenses were $265.7 million, up from $209.1 million. Madrigal said the increase was primarily due to continued investment in commercial activities for Rezdiffra, including headcount for an endocrinology field-force expansion that began in the fourth quarter of 2025 and a direct-to-consumer campaign.

Cash, cash equivalents, restricted cash and marketable securities were $961.8 million as of Sept. 30, 2026, compared with $838.9 million as of June 30 and $817.9 million as of March 31.

Madrigal announced a new Phase 3 MAESTRO-CSPH outcomes trial in well-compensated MASH cirrhosis (F4c), expected to enroll more than 2,000 patients enriched for clinically significant portal hypertension. Trial initiation is expected in the first half of 2027, subject to regulatory discussions. The company said the ongoing MAESTRO-NASH OUTCOMES trial is on track, with data expected late 2027.

Sibold said Madrigal’s objective in F4c is to be first and best, and that MAESTRO-CSPH is expected to extend the company’s competitive advantage.

The company said it will have a significant presence at the American Association for the Study of Liver Diseases Liver Meeting Nov. 5-9 in Denver, with 18 accepted abstracts, including 13 based on real-world evidence, with the largest dataset spanning nearly 12,000 patients.

In August, Madrigal appointed John C. Reed, M.D., Ph.D., to its board.

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