Madrigal Posts First Profit as Rezdiffra Q3 Sales Rise 50%

Madrigal Pharmaceuticals Inc. (NASDAQ: MDGL) reported its first profitable quarter as continued uptake of MASH treatment Rezdiffra lifted third-quarter 2026 net product sales by 50% from a year earlier. The company also outlined plans to expand the drug’s clinical program in compensated MASH cirrhosis, a potential market that it estimates could double Rezdiffra’s opportunity.

Rezdiffra generated net sales of $431.3 million for the three months ended Sept. 30, up from $287.3 million in the prior-year period. Sales exceeded $1.1 billion for the first nine months of 2026.

The number of patients receiving Rezdiffra rose to more than 55,850 at the end of the quarter, compared with more than 29,500 a year earlier, based on specialty-pharmacy and distribution dispense data. Madrigal said the drug remains the market leader among patients with F2-F3 MASH, the population covered by its current indication.

Profitability and cash position

Madrigal recorded third-quarter operating income of $56.0 million, reversing an operating loss of $114.0 million a year earlier. Net income was $55.4 million, or $1.83 per diluted share, compared with a net loss of $114.2 million, or $4.01 per share, in the third quarter of 2025.

Total operating expenses declined to $375.3 million from $401.2 million. Research and development expense fell to $71.8 million from $174.0 million, while selling, general and administrative expense increased to $265.7 million from $209.1 million. Cost of sales rose to $37.8 million from $18.1 million as product revenue increased.

The company ended September with $961.8 million in cash, cash equivalents, restricted cash and marketable securities.

Early-stage market penetration leaves room for expansion

Madrigal said the addressable U.S. market of diagnosed F2-F3 MASH patients seeing targeted liver specialists increased from about 460,000 at the end of 2025 to roughly 530,000 as of June 30, 2026. The company expects that population to grow by more than 30% by the end of 2026.

The presentation estimated that about 10% of MASH patients are currently diagnosed and that Rezdiffra has penetrated roughly 10% of its target market. Madrigal identified diagnosis rates, disease awareness, urgency to treat, new market entrants and treatment penetration as factors affecting market development.

Rezdiffra is approved under an accelerated, or conditional, approval pathway for F2-F3 MASH based on improvement in MASH and fibrosis. Continued approval may depend on confirmatory trials verifying and describing the drug’s clinical benefit.

Cirrhosis program targets a larger potential market

Madrigal is also seeking to extend Rezdiffra into compensated MASH cirrhosis, or F4c. It now estimates that approximately 360,000 diagnosed U.S. F4c patients are being seen by targeted liver specialists, more than 45% above its prior estimate of 245,000. The company said the F4c population could double Rezdiffra’s overall opportunity.

The ongoing placebo-controlled Phase 3 MAESTRO-NASH OUTCOMES trial has enrolled 845 patients and uses liver-related clinical outcomes as its primary endpoint. Madrigal expects data in late 2027. The company said positive results could support an F4c indication and full approval across F2-F4c MASH.

Madrigal also plans to begin the Phase 3 MAESTRO-CSPH trial in the first half of 2027, following discussions with the U.S. Food and Drug Administration. The study is expected to enroll more than 2,000 patients and will be enriched for clinically significant portal hypertension, or CSPH. Together, MAESTRO-NASH OUTCOMES and MAESTRO-CSPH would comprise an outcomes-based F4c program of about 3,000 patients.

The broader pipeline includes combination programs pairing resmetirom with other investigational agents. A drug-interaction study of resmetirom and oral DGAT-2 inhibitor ervogastat began in October 2026, with a Phase 2 combination trial expected in 2027 following regulatory discussions. Madrigal also initiated a Phase 1 single-ascending-dose trial of oral GLP-1 receptor agonist MGL-2086 in the second quarter of 2026 and is developing MGL-0795, an siRNA targeting PNPLA3, as another potential combination candidate.

Madrigal’s outlook remains subject to commercialization and clinical-development risks. These include demand for Rezdiffra, the company’s ability to secure and maintain regulatory approvals, trial enrollment and timing, the possibility of adverse safety events, competitor results, intellectual-property protection, debt obligations and the risk that confirmatory studies may not establish the clinical benefit needed to maintain or broaden the drug’s approval.