Madrigal Pharmaceuticals NASDAQ: MDGL reported first-quarter 2026 net sales of $311.3 million as executives said demand for its MASH therapy Rezdiffra continued to build in a market they described as still early in development. On the company’s earnings call, management highlighted patient growth, expanding diagnosis and specialist engagement, and progress toward a broader MASH pipeline that includes combination strategies and an outcomes program in cirrhosis.
Rezdiffra sales growth and patient momentum
CEO Bill Sibold said 2026 is “off to a terrific start” and noted Rezdiffra has reached blockbuster status, with more than $1.1 billion in net sales over the last 12 months. He characterized that as a billion-dollar run rate “in a market that’s still in its infancy,” citing low diagnosis rates and low penetration as indicators of remaining runway.
For the first quarter, Sibold said net sales of $311 million represented 127% year-over-year growth. He added that Madrigal ended the quarter with more than 42,250 active patients on Rezdiffra, which he said was about 2.5 times higher than the first quarter of 2025. Sibold also said the company was seeing that momentum continue into the second quarter, telling analysts that “April… has been our best NBRx month since launch.”
Management pointed to the expansion of the diagnosed and specialist-seen market. Sibold said the U.S. addressable market—diagnosed F2/F3 patients seen by target specialists—grew nearly 50% from 315,000 patients at the end of 2023 to 460,000 patients at the end of 2025. He said the diagnosis rate was “just over 10%” and Rezdiffra penetration “just under 10%” of the addressable population.
Prescriber breadth, specialty mix, and GLP-1 overlap
On prescribing dynamics, Sibold said Madrigal now has “over 10,000 prescribers,” and he expects gastroenterologists to account for most prescriptions because they outnumber hepatologists 10-to-1. He said hepatologists “were out of the gates a little faster,” while endocrinology is earlier in its adoption curve; Madrigal began expanded efforts in endocrinology in the fourth quarter of 2025 and is “wiring the system for each of those endocrinologists as well.”
When asked about the effect of GLP-1 competition, Sibold said Wegovy has been in the MASH market for three quarters and is “being used, but certainly not to the detriment of Rezdiffra.” He described GLP-1s as increasingly a “background therapy,” with many patients already taking one when they arrive at the specialist’s office.
Sibold said the overlap remains significant:
- “25+%” of Rezdiffra patients are concomitantly on a GLP-1, he said, and he expects that to increase.
- “Over 50%” of Rezdiffra patients have been previously exposed to a GLP-1, according to Sibold.
On payer dynamics, Sibold said Rezdiffra continues to have “exceptional access,” including after 2026 contracting. He said a GLP-1 can be used alongside Rezdiffra if the GLP-1 is prescribed for another indicated condition, adding that the company does not have good data on “double MASH” prescribing and that it does not think payers would allow it.
Regarding disease severity, Sibold said the real-world mix has remained about “50-50” between F2 and F3 patients, pushing back on the idea that prescribers would prioritize only more advanced F3 patients.
Evidence generation and the F4-C expansion opportunity
Madrigal also emphasized ongoing evidence generation. Sibold said more than 40 Rezdiffra abstracts are being presented at hepatology, gastroenterology, and endocrinology-focused meetings this month. He cited a DDW poster in which nearly 70% of surveyed Rezdiffra prescribers said the drug improved patients’ quality of life, and nearly 70% said they expect to increase use over the next six months. He also previewed EASL presentations including secondary analyses from MAESTRO-NASH and MAESTRO-NAFLD-1 showing reductions in Lp(a) and LDL-C “independent of baseline statin use,” along with additional real-world datasets.
A major focus for the company remains expansion into well-compensated MASH cirrhosis (F4-C). Sibold said F4-C could “double Rezdiffra’s opportunity” and cited approximately 245,000 patients under specialist care in the U.S. He said an event-driven outcomes trial is underway and, if positive, is expected to support both an F4-C indication expansion and full approval across F2 through F4-C.
Chief Medical Officer David Soergel said confidence in the MAESTRO-NASH OUTCOMES program is informed by two-year open-label experience in 122 F4-C patients from MAESTRO-NAFLD-1. He highlighted CSPH (clinically significant portal hypertension) as a key inflection point in disease progression and said that in the two-year dataset, “65% of patients with CSPH at baseline shifted into lower risk categories by year two,” alongside favorable movement in biomarkers such as liver stiffness and fibrosis-related measures.
Soergel said event rates in MAESTRO-NASH OUTCOMES are “tracking in range of our expectations,” and Madrigal continues to project a 2027 readout. He added that the company would provide updates when it has greater precision.
Pipeline buildout and combination strategy
Soergel said Madrigal’s R&D goal is to “deliver the industry-leading pipeline in MASH” with Rezdiffra as the foundation, and he outlined four priorities: delivering outcomes data and full approval for Rezdiffra across F2–F4-C; advancing complementary mechanisms for combination therapy; remaining modality agnostic; and designing efficient, informative clinical trials while advancing only programs that “serve patients’ needs more effectively.”
The company’s newest addition is ARO-PNPLA3, a clinical-stage siRNA in-licensed from Arrowhead. Soergel said PNPLA3 is a genetically validated driver of disease and that approximately 30% of F2/F3 MASH patients are homozygous carriers of the I148M mutation. He added that in phase I, after a single dose, ARO-PNPLA3 reduced liver fat “by up to 46% at 12 weeks at the highest dose,” and he said the asset appears selectively effective in the genetically defined population.
Soergel described the strategic intent as pairing a broadly effective foundational therapy with a targeted agent that could move more patients into a “high response category” and potentially improve anti-fibrotic efficacy. He said Madrigal’s next step for ARO-PNPLA3 is engaging regulators on a phase II combination trial.
Elsewhere in the pipeline, Soergel said:
- Rezdiffra continues in two phase III outcomes-based trials: the F4-C event-driven trial (expected readout in 2027) and an F2/F3 study primarily driven by histology (data expected in 2028).
- For ervogastat (DGAT2 inhibitor), a drug-drug interaction study with resmetirom is on track to begin in the fourth quarter of 2026, with a phase II combination study planned for 2027 following regulatory discussions.
- For MGL-2086 (oral GLP-1), the phase I single ascending dose study is expected to initiate later in the quarter.
- Six siRNA targets are progressing through various stages of preclinical development.
On decision-making, Soergel said advancement will be data-driven, with early combination work relying on biomarkers such as MRI-PDFF along with fibrosis-related imaging and blood-based biomarkers. Sibold added the company intends to move programs forward “fast” if they show benefit and stop them quickly if they do not.
Expenses, gross-to-net outlook, and cash position
CFO Mardi Dier said first-quarter results reflected a “typical Q1 effect” tied to benefit plan changes and insurance reverifications, along with a step-up in gross-to-net related to commercial contracting for first-line access. She said gross-to-net in the quarter was “better than we anticipated,” and Madrigal now expects gross-to-net discounts to be in the “mid to high thirties” for the rest of 2026.
Dier reported first-quarter cost of sales of $26.8 million versus $4.5 million a year earlier, saying cost of sales primarily reflects royalties owed to Roche. R&D expense was $108.7 million versus $44.2 million, driven primarily by $54.3 million of one-time upfront business development expenses. SG&A expense rose to $268.5 million from $167.9 million, which Dier attributed mainly to commercial investment for Rezdiffra, including endocrinology field force expansion and marketing efforts such as the company’s DTC campaign.
Net loss for the quarter was $94.4 million compared to $73.2 million a year earlier, and Dier said the loss included the $54.3 million one-time upfront business development expense. She said Madrigal is preparing for profitability but does not expect to be profitable in 2026, adding that one-time spending could affect profitability timing in future quarters.
On liquidity, Dier said the company ended the quarter with $817.9 million in cash, cash equivalents, restricted cash, and marketable securities, down from $988.6 million at the end of 2025. She attributed the decline to quarter-specific cash uses including one-time upfront business development payments and the timing of API purchases to support future Rezdiffra manufacturing.
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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