What Madrigal Pharmaceuticals (MDGL) Said on Its Q3 Earnings Call

Key Points

• Rezdiffra sales surged: Third-quarter revenue rose 50% year over year to $431.3 million, with more than 55,850 active patients and the company’s first profitable quarter. Madrigal ended September with $961.8 million in cash and positive operating cash flow for the second consecutive quarter.
• MASH market opportunity is expanding: The diagnosed U.S. F2/F3 patient population grew to over 530,000, while Rezdiffra has penetrated only about 10% of that market. Madrigal is broadening outreach to endocrinologists and expects continued patient and prescriber growth.
• Pipeline development is advancing: Madrigal expects late-2027 results from its Phase III F4c MASH outcomes trial and plans to begin a second large Phase III study in 2027. It also plans three Phase II Rezdiffra combination trials involving DGAT2, GLP-1 and PNPLA3-targeting therapies.

Madrigal Pharmaceuticals NASDAQ: MDGL reported third-quarter 2026 net sales of $431.3 million for its MASH treatment Rezdiffra, up 50% from the prior-year period, as the company said it continued to add patients and expand its prescriber base. Year-to-date net sales reached $1.1 billion, and the company reported its first profitable quarter.

Chief Executive Officer Bill Sibold said the quarterly sales result annualizes to more than $1.7 billion and described Rezdiffra as the company’s foundational therapy for metabolic dysfunction-associated steatohepatitis, or MASH. The company ended the quarter with more than 55,850 active patients on Rezdiffra, nearly double the more than 29,500 active patients reported a year earlier.

“We are firing on all cylinders,” Sibold said during the company’s earnings call, citing demand growth, access and a growing diagnosed patient population.

Diagnosed MASH Market Expands

Madrigal said the diagnosed U.S. population of patients with F2/F3 MASH rose to more than 530,000 as of June 30, from 460,000 at the end of 2025. The company expects the market to grow by more than 30% during 2026, primarily due to greater awareness and diagnosis.

Sibold said the MASH diagnosis rate remains around 10%, while Rezdiffra has penetrated about 10% of the diagnosed market. He said the figures indicate that the company is still early in addressing the broader opportunity.

The company is also expanding its commercial outreach to endocrinologists. Sibold said endocrinology practices have substantial numbers of potential MASH patients and that physicians in the specialty are beginning to establish testing and treatment pathways. He said endocrinologists that begin prescribing have tended to increase their use of Rezdiffra relatively quickly, though the company expects adoption to take time.

Regarding the fourth quarter, Chief Financial Officer Mardi Dier said Madrigal expects to continue steadily adding patients and said management was comfortable with consensus expectations for sequential growth from the third to fourth quarter. The company did not provide formal revenue guidance for 2027, but Dier said the business had momentum entering the year.

F4c Development Program Advances

Madrigal is pursuing an expansion into compensated cirrhosis, or F4c, MASH. The company now estimates there are 360,000 addressable F4c patients in the United States, up more than 45% from its prior estimate of 245,000 patients.

Its ongoing MAESTRO-NASH OUTCOMES study is an 845-patient, placebo-controlled, event-driven Phase III trial in F4c MASH. The primary endpoint is improvement in liver-related clinical outcomes. Chief Medical Officer Dave Soergel said a positive study could support an F4c indication as well as full approval across F2 through F4c MASH. Madrigal now expects results from the trial in late 2027.

Soergel said the company continues to monitor blinded event accrual and patient retention, and that dropout rates have been within its expectations. He noted that the trial will not stop if it has not accumulated the required number of events by the end of 2027.

In parallel, Madrigal plans to initiate MAESTRO-CSPH, a second Phase III outcomes study, in the first half of 2027, pending discussions with the FDA and protocol finalization. The trial is expected to enroll more than 2,000 patients and will be enriched for clinically significant portal hypertension, or CSPH. Results are expected in the early 2030s.

Soergel said the company intends to use imaging, biomarkers and its prior F4c trial experience to identify patients at elevated risk of progression while avoiding patients whose disease may be too advanced for treatment to be effective. Combined, MAESTRO-NASH OUTCOMES and MAESTRO-CSPH are expected to include approximately 3,000 patients.

Combination Pipeline and Real-World Evidence

Madrigal said it plans to present 13 real-world Rezdiffra data abstracts at the American Association for the Study of Liver Diseases meeting, including an analysis involving nearly 12,000 patients. Soergel said the company is also evaluating Rezdiffra in practice-focused studies involving treatments for common comorbidities, including pioglitazone and SGLT2 inhibitors.

The company’s pipeline includes more than 10 resmetirom combination programs. Madrigal expects to initiate three Phase II combination trials in 2027, following regulatory discussions:

• Rezdiffra with ervogastat, an oral DGAT2 inhibitor;
• Rezdiffra with MGL-2086, an oral GLP-1 agonist; and
• Rezdiffra with MGL-0795, an siRNA therapy targeting PNPLA3 for patients homozygous for a disease-accelerating PNPLA3 mutation.

Management said approximately 25% to 30% of patients enrolled in MAESTRO-NASH OUTCOMES were on stable GLP-1 treatment at the beginning of the study. Sibold said GLP-1 medicines have generally functioned as a background therapy for Rezdiffra patients and that the presence of Wegovy in the MASH market had not affected Rezdiffra’s growth. He added that Madrigal believes weight loss from an oral GLP-1 combination could potentially enhance Rezdiffra’s antifibrotic effect while maintaining tolerability.

First Quarterly Profitability

Madrigal reported net income of $55.4 million in the third quarter, compared with a net loss of $114.2 million a year earlier. Dier said the company has generated positive operating cash flow for the past two quarters and ended September with $961.8 million in cash.

Third-quarter cost of sales rose to $37.8 million from $18.1 million, primarily reflecting increased royalties payable to Roche. Research and development expense declined to $71.8 million from $174 million, primarily because the prior-year quarter included $117.3 million in one-time upfront business development expense. Selling, general and administrative expense increased to $265.7 million from $209.1 million as Madrigal continued investing in Rezdiffra commercial activities.

The company expects full-year 2026 R&D expense to be nominally below 2025 levels, while SG&A expense is expected to increase as it supports commercial growth. Dier said fourth-quarter SG&A expense is expected to be higher than the third quarter because of the timing of marketing expenses.

Madrigal expects 2026 gross-to-net deductions to be at the low end of its mid-to-high 30% range. For 2027, Dier said the company expects gross-to-net to be approximately the high end of that range as Medicare Part D contracts take effect. She said Madrigal may move in and out of profitability in the near term as it continues to invest in commercial expansion, clinical programs and business development.

About Madrigal Pharmaceuticals (NASDAQ:MDGL)

Madrigal Pharmaceuticals, Inc is a biopharmaceutical company focused on developing and commercializing medicines for nonalcoholic steatohepatitis, now known as metabolic dysfunction-associated steatohepatitis (MASH), and other chronic liver diseases. The company is headquartered in West Conshohocken, Pennsylvania.

Madrigal's lead product is Rezdiffra (resmetirom), an orally administered thyroid hormone receptor beta agonist designed to target key drivers of liver disease, including hepatic fat accumulation and fibrosis.

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