CONSHOHOCKEN, PA — Madrigal Pharmaceuticals Inc. (Nasdaq: MDGL) reported its first profitable quarter as sales of its liver disease treatment Rezdiffra rose 50% to $431.3 million in the third quarter of 2026, marking a financial turning point for the Conshohocken-based biotechnology company as it expands its commercial operations and pursues additional treatment indications.
The company recorded net income of $55.4 million, or $1.83 per diluted share, compared with a net loss of $114.2 million, or $4.01 per share, a year earlier.
Rezdiffra, also known as resmetirom, generated $1.1 billion in net sales during the first nine months of 2026, crossing the annual $1 billion threshold commonly used to define a blockbuster pharmaceutical product.
The sales milestone underscores the commercial growth of the treatment for metabolic dysfunction-associated steatohepatitis, or MASH, a serious liver disease associated with fat accumulation, inflammation and progressive liver damage.
Madrigal reported that more than 55,850 patients were receiving Rezdiffra as of Sept. 30, nearly twice the number a year earlier, reflecting increased physician prescribing and patient adoption.
The company also estimates that the addressable U.S. market for patients with MASH and moderate to advanced liver fibrosis, classified as F2-F3 disease, exceeded 530,000 people through June 30.
Madrigal projects that the addressable population will grow more than 30% by the end of 2026, expanding the potential market for Rezdiffra.
“Madrigal delivered another strong quarter, driven by continued Rezdiffra demand, deepening prescriber adoption and accelerating market growth,” Chief Executive Officer Bill Sibold stated.
Sibold characterized the company as being in the early stages of commercial development despite Rezdiffra’s rapid sales expansion.
The company’s financial results also reflected changes in research spending and continued investment in marketing and sales operations.
Third-quarter operating expenses declined to $375.3 million from $401.2 million a year earlier, despite higher spending on commercial activities.
Research and development expenses fell to $71.8 million from $174 million in the comparable 2025 quarter, primarily because the earlier period included a one-time $117.3 million upfront business development expense.
Selling, general and administrative expenses increased to $265.7 million from $209.1 million, reflecting additional investment in Rezdiffra’s commercial expansion.
Those expenditures included staffing for an endocrinology sales force expansion that began in the fourth quarter of 2025, along with marketing initiatives and a direct-to-consumer advertising campaign.
Cost of sales rose to $37.8 million from $18.1 million, largely because higher Rezdiffra revenue increased royalty payments owed to Roche.
Operating expenses included $38.9 million in noncash stock-based compensation, compared with $26.3 million in the prior-year quarter.
Madrigal reported basic earnings of $1.90 per share for the quarter, compared with a basic loss of $4.01 per share a year earlier.
The company ended September with $961.8 million in cash, cash equivalents, restricted cash and marketable securities, down from $988.6 million at the end of 2025.
The financial position provides resources for continued commercialization of Rezdiffra and development of additional treatments as Madrigal seeks to expand its presence in the MASH market.
A major component of that strategy involves extending treatment into well-compensated MASH cirrhosis, classified as F4c, an advanced stage of liver disease.
Madrigal plans to initiate a second Phase 3 clinical outcomes trial, MAESTRO-CSPH, during the first half of 2027, subject to regulatory discussions.
The study is expected to enroll more than 2,000 patients with well-compensated MASH cirrhosis, with substantial representation of patients experiencing clinically significant portal hypertension.
Portal hypertension involves elevated blood pressure in the veins supplying the liver and is associated with complications of advanced liver disease.
The trial will evaluate clinical outcomes while generating data intended to support the validation of noninvasive biomarkers for Rezdiffra and future treatments.
MAESTRO-CSPH will complement the company’s ongoing MAESTRO-NASH OUTCOMES trial, which is also evaluating Rezdiffra in patients with advanced MASH.
Madrigal expects data from MAESTRO-NASH OUTCOMES in late 2027.
The studies represent an effort to expand the treatment’s potential use beyond its existing F2-F3 market and establish a position in the more advanced cirrhosis population.
“Our ongoing MAESTRO-NASH OUTCOMES trial positions us to deliver the first approved therapy to patients with this advanced stage of MASH,” Sibold stated.
He described MAESTRO-CSPH as an additional clinical program intended to strengthen the company’s position in treating advanced liver disease.
Madrigal is also expanding its clinical evidence base through analyses of treatment outcomes and genetic factors associated with MASH progression.
A secondary analysis of the Phase 3 MAESTRO-NASH trial, published in the Journal of Hepatology, found that Rezdiffra improved liver tissue measurements and MRI-based liver fat assessments across several common genetic variants associated with the disease.
The variants included PNPLA3, HSD17B13, TM6SF2, MTARC1 and MBOAT7.
The findings provide additional evidence concerning Rezdiffra’s treatment effects among patients with different genetic risk profiles.
Madrigal also reported that 18 abstracts involving its research were accepted for the American Association for the Study of Liver Diseases’ annual Liver Meeting, held Nov. 5-9 in Denver.
Thirteen of those abstracts focus on real-world evidence, including an analysis involving nearly 12,000 patients.
The research adds to the company’s clinical development program by examining treatment use and outcomes beyond the original controlled trials.
Separately, Madrigal appointed John C. Reed, M.D., Ph.D., to its board of directors in August.
Reed serves as executive vice president of Innovative Medicine Research and Development at Johnson & Johnson, where he oversees research programs spanning oncology, immunology and neuroscience.
He previously held senior executive positions at Sanofi and Roche.
Madrigal’s first profitable quarter and Rezdiffra’s billion-dollar sales milestone mark a shift from commercial launch toward sustained pharmaceutical operations.
The company’s next phase will depend on maintaining growth in the existing MASH treatment market while advancing clinical studies that could broaden Rezdiffra’s use among patients with more advanced liver disease.
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