Madrigal Pharmaceuticals Q2 Earnings Call Highlights
Key Points
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- Rezdiffra sales rose 71% year over year to $364.3 million in Q2 2026, with nearly $1.3 billion in trailing 12-month sales and more than 49,000 active patients. Madrigal said demand remains strong, while the diagnosed U.S. specialist-addressable market continues to expand.
- Madrigal reported a $57.9 million quarterly net loss, pressured by a $25 million Arrowhead licensing payment and higher commercial spending. Cash, restricted cash and marketable securities declined to $838.9 million from $988.6 million at year-end 2025.
- The company expects its F4C cirrhosis Phase III trial to read out in 2027 and is advancing additional MASH programs, including MGL-2086, ervogastat and MGL0795 combinations. New Rezdiffra patents could extend protection into the 2040s, with existing F2-F3 protection extending to 2045.
Madrigal Pharmaceuticals (NASDAQ:MDGL) reported second-quarter 2026 net sales of $364.3 million for Rezdiffra, up 71% from a year earlier, as the company continued to expand the number of patients receiving its treatment for metabolic dysfunction-associated steatohepatitis, or MASH.
The company said Rezdiffra had generated nearly $1.3 billion in trailing 12-month net sales and ended the quarter with more than 49,000 active patients, more than double the level reported a year earlier. Madrigal said it surpassed 50,000 active patients earlier in July.
“Demand for Rezdiffra remains strong,” Chief Executive Officer Bill Sibold said during the company’s earnings call. He said prescriptions continue to be driven primarily by hepatologists and gastroenterologists, while the company is still early in its effort to reach endocrinologists, which began in the fourth quarter of 2025.
Market Expansion and Commercial Outlook
Madrigal said the U.S. addressable market for diagnosed F2/F3 MASH patients treated by its target specialists grew to approximately 460,000 patients at the end of 2025, compared with 315,000 at the end of 2023. Sibold attributed the expansion to increased disease awareness, diagnosis, referrals to specialists and urgency to treat patients.
The company said it expects the MASH market to continue growing at a double-digit rate for the foreseeable future. Sibold said Madrigal estimates the market remains at an early stage, with roughly 10% diagnosis and about 10% penetration among diagnosed patients.
Chief Financial Officer Mardi Dier said the company was comfortable with consensus quarterly growth rates for the remainder of 2026 and expects continued steady patient additions through the third and fourth quarters. Madrigal maintained its expectation that its full-year gross-to-net discount will remain in the mid- to high-30% range.
International revenue made a negligible contribution during the quarter, according to Sibold. The company has launched Rezdiffra in Germany, begun an early-access program in France and received approval in the United Kingdom. However, he said reimbursement remains a challenge amid uncertainty surrounding most-favored-nation pricing policies and related discussions with governments.
Financial Results and Spending
Madrigal reported a second-quarter net loss of $57.9 million, compared with a net loss of $42.3 million in the prior-year period. The quarterly loss included a $25 million one-time upfront business-development expense tied to the in-licensing of MGL0795, an siRNA program from Arrowhead Pharmaceuticals.
- Cost of sales was $40 million, compared with $9.1 million a year earlier, primarily reflecting higher royalties payable to Roche and a write-down of certain work-in-process inventory.
- Research and development expense rose to $91.2 million from $54.1 million, driven largely by the Arrowhead upfront payment.
- Selling, general and administrative expense increased to $289.4 million from $196.9 million, reflecting commercial investment in Rezdiffra, including the endocrinology field-force expansion and direct-to-consumer marketing.
- Stock-based compensation expense totaled $35.4 million, up from $25.2 million in the prior-year quarter.
The company ended the quarter with $838.9 million in cash equivalents, restricted cash and marketable securities, down from $988.6 million at the end of 2025. Dier said Madrigal expects full-year R spending to be roughly in line with 2025, including announced business-development upfront payments, while SG spending is expected to increase as the company supports Rezdiffra’s launch.
F4 Cirrhosis Study and Clinical Evidence
Madrigal is conducting the event-driven Phase III MAESTRO-NASH OUTCOMES trial in patients with well-compensated MASH cirrhosis, known as F4C. The company expects the study to read out in 2027 and said events are accruing in line with that timeframe, though management did not provide a more specific date or confirm the final target number of events.
Chief Medical Officer Dave Allegretti said the company has enriched the trial population for risk of clinically significant portal hypertension using measures including platelet counts, liver stiffness and magnetic resonance elastography. He said any statistically significant risk reduction that supports approval could be clinically meaningful because no approved therapy currently exists for F4C MASH.
At the European Association for the Study of the Liver meeting, Madrigal presented an analysis of a 122-patient open-label cohort from the MAESTRO-NAFLD-1 trial. Using the ANTICIPATE-MASH risk model, the company said the proportion of patients considered at higher risk for clinically significant portal hypertension declined from 75% at baseline to 55% after two years of resmetirom treatment.
Madrigal also cited real-world data from one large gastroenterology practice, where nearly half of patients achieved at least a 25% reduction in liver stiffness over an average follow-up of about nine months.
Pipeline Plans and Patent Protection
The company said it has built a MASH pipeline of more than 10 programs, including four clinical-stage assets. Madrigal began dosing its oral GLP-1 candidate, MGL-2086, in a Phase I single-ascending-dose study in June. Results from the single-ascending-dose and multiple-ascending-dose work are expected to inform a planned Phase II combination study with resmetirom in 2027.
Madrigal also plans to initiate Phase II studies in 2027 evaluating its DGAT2 inhibitor, ervogastat, with resmetirom and evaluating a combination of resmetirom and MGL0795, the PNPLA3-targeting siRNA licensed from Arrowhead. The company’s F2-F3 MAESTRO-NASH Phase III study is expected to report data in 2028.
Sibold said Madrigal recently received three additional patents related to Rezdiffra, including two patents supporting protection in F2-F3 MASH and one supporting a potential F4C indication. He said the company’s previously secured F2-F3 patent extends to 2045, while the newer F4C patent extends into the 2040s.
About Madrigal Pharmaceuticals (NASDAQ:MDGL)
Madrigal Pharmaceuticals, Inc is a clinical-stage biopharmaceutical company focused on the development of innovative therapies for cardiovascular, metabolic and liver diseases. The company's pipeline centers on novel, liver-directed agents designed to address significant unmet medical needs, with an emphasis on nonalcoholic steatohepatitis (NASH) and related metabolic disorders.
The lead product candidate, resmetirom (MGL-3196), is an orally administered, selective thyroid hormone receptor-β agonist in Phase 3 development for the treatment of NASH.
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