Madrigal Pharmaceuticals (NASDAQ:MDGL) reported a return to profitability in the third quarter of 2026, supported by growing demand for its liver disease treatment Rezdiffra. The biopharmaceutical company’s quarterly revenue increased 50% year over year to $431.3 million, while net income reached $55.4 million, compared with a loss of $114.2 million in the corresponding period last year.
The results marked another milestone for Rezdiffra (resmetirom), which surpassed $1 billion in year-to-date net sales, achieving blockbuster drug status less than three years after its commercial launch.
Madrigal also announced plans for a new Phase 3 clinical trial targeting patients with well-compensated cirrhosis caused by metabolic dysfunction-associated steatohepatitis (MASH), as it seeks to expand Rezdiffra’s potential use beyond its existing approved indication.
Chief Executive Officer Bill Sibold said the company was benefiting from stronger demand, increased adoption among prescribing physicians and continued expansion of the addressable MASH treatment market.
How Did Madrigal’s Third-Quarter Financial Results Compare With Last Year?
Madrigal generated third-quarter net revenue of $431.3 million, representing a 50% increase from $287.3 million in the same period of 2025.
The growth was driven by higher US demand for Rezdiffra, the company’s once-daily oral treatment for MASH patients with moderate to advanced liver fibrosis.
The company reported net income of $55.4 million, equivalent to $1.90 per basic share and $1.83 per diluted share.
That compared with a net loss of $114.2 million, or $4.01 per basic and diluted share, in the prior-year quarter.
The improvement reflected stronger product revenue alongside lower total operating expenses.
Operating expenses declined to $375.3 million from $401.2 million a year earlier, despite continued investment in Rezdiffra’s commercial expansion.
The results demonstrated Madrigal’s transition from substantial quarterly losses to profitability as its commercial business continues to grow.
Why Is Rezdiffra’s $1 Billion Sales Milestone Significant?
Rezdiffra surpassed $1 billion in year-to-date net sales during 2026, reaching the pharmaceutical industry’s commonly used blockbuster threshold.
The milestone was achieved less than three years after the treatment’s launch.
Rezdiffra was the first medication approved by both the US Food and Drug Administration and the European Commission for MASH with moderate to advanced liver fibrosis, corresponding to stages F2 and F3.
Its commercial growth has been supported by increasing physician adoption and a growing number of patients receiving treatment.
Sibold highlighted the significance of the sales milestone and the company’s position within the developing MASH market.
“Madrigal delivered another strong quarter, driven by continued Rezdiffra demand, deepening prescriber adoption and accelerating market growth,” he said.
“Rezdiffra surpassed $1 billion in year-to-date net sales, achieving blockbuster status less than three years after launch, and we are still early in a rapidly growing market.”
The company expects the expanding population of diagnosed and eligible MASH patients to provide additional opportunities for growth.
How Quickly Is the US MASH Treatment Market Expanding?
Madrigal estimates that the addressable US market for patients with F2-F3 MASH is on track to expand by more than 30% by the end of 2026.
The projection reflects the company’s assessment of the rapidly developing market for treatments targeting patients with moderate to advanced liver fibrosis.
MASH is a progressive liver disease associated with metabolic dysfunction and inflammation that can lead to fibrosis, cirrhosis and other serious complications.
As awareness and diagnosis improve, more patients are being identified as candidates for treatment.
Sibold said the company’s latest analysis reinforced the scale of the opportunity.
“Our latest analysis shows the addressable U.S. F2-F3 market is on track to increase more than 30 percent by year-end 2026, reinforcing how quickly this category is developing and the significant runway ahead.”
The projected market expansion is particularly important for Madrigal because Rezdiffra is already approved for patients with F2-F3 disease.
The company is also pursuing clinical development in patients with more advanced MASH-related liver disease.
Can Madrigal Expand Rezdiffra Into Compensated MASH Cirrhosis?
Madrigal identified well-compensated MASH cirrhosis, known as F4c, as its next major clinical development opportunity.
Patients with F4c have progressed to cirrhosis but have not developed certain complications associated with decompensated liver disease.
The company is seeking to establish Rezdiffra as a treatment option for this more advanced patient population.
Its ongoing MAESTRO-NASH OUTCOMES Phase 3 study is evaluating Rezdiffra in patients with compensated MASH cirrhosis.
Madrigal believes the trial could support a future regulatory approval in this indication, although approval would depend on clinical results and regulatory review.
Sibold described the company’s ambitions for the programme.
“Madrigal’s next major opportunity is in well-compensated cirrhosis, or F4c, an urgent unmet need for patients. Our objective in F4c is clear: be first and best.”
He added that the ongoing outcomes study could position Madrigal to deliver the first approved treatment for patients with this advanced stage of MASH.
What Is the New MAESTRO-CSPH Phase 3 Trial?
Madrigal announced plans to initiate MAESTRO-CSPH, a second Phase 3 outcomes trial focused on patients with well-compensated MASH cirrhosis.
The study is expected to enrol more than 2,000 patients with F4c disease.
Its population will be significantly enriched for patients with clinically significant portal hypertension, or CSPH, a condition associated with increased pressure in the portal venous system.
MAESTRO-CSPH will be an event-driven outcomes trial, designed to evaluate clinically meaningful outcomes in patients with advanced liver disease.
The programme will complement the ongoing MAESTRO-NASH OUTCOMES study.
Madrigal expects the two trials to generate an extensive clinical dataset in F4c and potentially support the validation of noninvasive biomarkers for Rezdiffra and future pipeline treatments.
The company plans to initiate MAESTRO-CSPH during the first half of 2027, subject to regulatory discussions.
Management believes the additional study could strengthen its long-term position in the MASH treatment market.
What New Rezdiffra Data Will Madrigal Present at the AASLD Liver Meeting?
Madrigal plans to present a substantial body of clinical and real-world evidence at the American Association for the Study of Liver Diseases (AASLD) Liver Meeting, scheduled for November 5-9, 2026, in Denver, Colorado.
The company said resmetirom, the active ingredient in Rezdiffra, will be featured in more abstracts than any other MASH therapy at the conference.
A total of 18 Madrigal abstracts have been accepted.
Of these, 13 are based on real-world evidence, including a dataset covering nearly 12,000 patients.
The presentations are expected to provide additional information about Rezdiffra’s use and performance outside controlled clinical trial settings.
Real-world evidence can help researchers assess how treatments are used across broader patient populations and clinical environments.
The conference will provide an opportunity for Madrigal to share findings from its ongoing evidence-generation programme with liver disease specialists and researchers.
What Did the Latest Research Reveal About Rezdiffra’s Effectiveness?
Madrigal highlighted a recent publication in the Journal of Hepatology examining Rezdiffra’s performance across genetic variants associated with MASH progression.
The research involved a secondary analysis of the Phase 3 MAESTRO-NASH trial.
According to the company, Rezdiffra demonstrated consistent improvements in liver histology and MRI-proton density fat fraction (MRI-PDFF) across several common genetic risk variants.
The variants evaluated included PNPLA3, HSD17B13, TM6SF2, MTARC1 and MBOAT7.
Liver histology assesses changes in liver tissue, while MRI-PDFF is an imaging measure used to quantify liver fat.
The findings suggest that Rezdiffra’s observed treatment effects were maintained across the genetic subgroups examined in the analysis.
Madrigal said the results reinforced its view of Rezdiffra as a foundational treatment for MASH.
As a secondary analysis, the findings provide additional evidence about treatment response but do not establish efficacy for new indications beyond the drug’s existing approvals.
Why Did Operating Expenses Decline Despite Commercial Expansion?
Madrigal reported third-quarter operating expenses of $375.3 million, compared with $401.2 million in the prior-year period.
The current-quarter figure included $38.9 million in noncash stock-based compensation, up from $26.3 million a year earlier.
Research and development expenses declined sharply to $71.8 million from $174.0 million.
The decrease was primarily attributable to a one-time upfront business development expense of $117.3 million recorded during the third quarter of 2025.
The absence of that expense reduced the year-over-year comparison for research and development spending.
Meanwhile, selling, general and administrative expenses increased to $265.7 million from $209.1 million.
The increase reflected continued investment in Rezdiffra’s commercial activities, including additional employees supporting an endocrinology sales force expansion that began in the fourth quarter of 2025.
Marketing expenditure also increased, including spending on a direct-to-consumer advertising campaign.
The figures demonstrate that Madrigal continued to invest in commercial growth even as total reported operating expenses declined.
Why Did Rezdiffra’s Cost of Sales Increase?
Madrigal reported third-quarter cost of sales of $37.8 million, compared with $18.1 million in the corresponding period last year.
The increase was primarily driven by higher royalty payments owed to Roche as Rezdiffra’s net sales expanded.
Although cost of sales more than doubled, product revenue increased substantially during the same period.
The higher royalty expense reflects the financial obligations associated with Rezdiffra’s commercial performance.
The company did not identify manufacturing inefficiencies or supply disruptions as primary drivers of the increase.
With Rezdiffra generating more than $1 billion in year-to-date net sales, royalty payments remain an important component of Madrigal’s product-related expenses.
How Strong Is Madrigal’s Financial Position?
As of September 30, 2026, Madrigal held $961.8 million in cash, cash equivalents, restricted cash and marketable securities.
That compared with $988.6 million at December 31, 2025.
The balance declined by $26.8 million over the nine-month period.
The company reported positive third-quarter net income of $55.4 million, supported by the continued commercial growth of Rezdiffra.
Its financial resources provide funding for ongoing operations, commercial expansion and clinical development activities.
These include the existing MAESTRO-NASH OUTCOMES programme and the planned MAESTRO-CSPH Phase 3 trial.
The company did not provide a specific cash runway forecast in the announcement.
How Could the Appointment of John Reed Support Madrigal’s Development Strategy?
Madrigal also highlighted the appointment of John C. Reed, M.D., Ph.D., to its Board of Directors in August 2026.
Reed currently serves as Executive Vice President, Innovative Medicine, Research & Development at Johnson & Johnson.
In that role, he oversees research and development activities across oncology, immunology and neuroscience.
He previously held senior executive positions at Sanofi and Roche.
His experience in pharmaceutical research and development adds industry expertise to Madrigal’s board as the company advances its clinical pipeline.
The appointment comes during a period of expanding commercial operations and continued investment in late-stage MASH clinical programmes.
What Are the Next Major Milestones for Madrigal Pharmaceuticals?
Madrigal’s near-term priorities include continued Rezdiffra commercial growth and the advancement of its clinical development programmes.
The company expects the addressable US F2-F3 MASH market to expand by more than 30% by the end of 2026, potentially increasing the number of patients eligible for its approved treatment.
The upcoming AASLD Liver Meeting will provide an opportunity to present additional clinical and real-world evidence.
The ongoing MAESTRO-NASH OUTCOMES study remains central to Madrigal’s efforts to expand Rezdiffra into compensated MASH cirrhosis.
The planned MAESTRO-CSPH Phase 3 trial represents another important milestone, with initiation targeted for the first half of 2027, subject to regulatory discussions.
Investors will also be monitoring the company’s ability to sustain revenue growth while managing the costs associated with commercial expansion and clinical development.
Outlook
Madrigal Pharmaceuticals’ third-quarter results demonstrated the continued commercial expansion of Rezdiffra and a substantial improvement in profitability.
Revenue increased 50% to $431.3 million, while net income reached $55.4 million, reversing the $114.2 million loss reported a year earlier.
Diluted earnings per share improved to $1.83 from a loss of $4.01.
Rezdiffra’s year-to-date net sales surpassed $1 billion, reflecting growing physician adoption and demand for MASH treatment.
The company also reported lower total operating expenses, although commercial spending increased as it expanded its sales force and marketing activities.
Looking ahead, Madrigal is seeking to strengthen its position in the existing F2-F3 treatment market while advancing Rezdiffra into compensated MASH cirrhosis.
The planned MAESTRO-CSPH trial, continued MAESTRO-NASH OUTCOMES development and upcoming scientific presentations will be important milestones.
The company’s longer-term prospects will depend on sustained Rezdiffra adoption, clinical trial outcomes and the potential expansion of its approved treatment indications.
More About Madrigal Pharmaceuticals
Madrigal Pharmaceuticals is a US-based biopharmaceutical company focused on developing treatments for metabolic dysfunction-associated steatohepatitis, a progressive liver disease associated with inflammation and fibrosis.
Its principal commercial product is Rezdiffra (resmetirom), a once-daily oral therapy designed to target underlying mechanisms involved in MASH.
Rezdiffra is a liver-directed thyroid hormone receptor-beta (THR-β) agonist.
The treatment was the first medication approved by both the US Food and Drug Administration and the European Commission for MASH with moderate to advanced liver fibrosis, corresponding to stages F2 and F3.
Madrigal is also conducting clinical research into the potential use of Rezdiffra in patients with compensated MASH cirrhosis.
The company’s strategy combines the commercial development of Rezdiffra with clinical programmes aimed at addressing additional stages of MASH-related liver disease.