Madrigal Pharmaceuticals — Third Quarter 2026 Earnings Summary

Financial Performance:

• Third-quarter 2026 net revenues were $431.3 million, a 50% year-over-year increase compared to $287.3 million in the same period in 2025.
• Rezdiffra net sales for the quarter were $431.3 million, contributing to year-to-date net sales of $1.1 billion.
• Third-quarter 2026 net income was $55.4 million ($1.90 per basic share and $1.83 per diluted share), a turnaround from a net loss of $114.2 million ($4.01 per basic and diluted share) in the prior year period.
• Operating expenses were $375.3 million in Q3 2026, down from $401.2 million in Q3 2025; this includes $38.9 million in non-cash stock-based compensation compared to $26.3 million in the prior year.
• Cost of sales was $37.8 million in Q3 2026, up from $18.1 million in Q3 2025, primarily driven by higher royalties payable to Roche due to increased Rezdiffra sales.
• R&D expenses were $71.8 million in Q3 2026, down from $174.0 million in Q3 2025, primarily due to a one-time $117.3 million business development expense in the prior year period.
• SG&A expenses were $265.7 million in Q3 2026, up from $209.1 million in Q3 2025, driven by commercial investments including endocrinology field force expansion and direct-to-consumer marketing.
• As of September 30, 2026, the company held $961.8 million in cash, cash equivalents, restricted cash, and marketable securities, down from $988.6 million as of December 31, 2025.

Guidance and Future Outlook:

• The U.S. F2-F3 MASH market is accelerating, growing to more than 530,000 addressable patients through June 30, 2026, and is on track for more than 30% growth by year-end 2026.
• The MAESTRO-NASH OUTCOMES trial data is expected in late 2027.
• The MAESTRO-CSPH Phase 3 trial is expected to initiate in the first half of 2027, subject to regulatory discussions.

Business Segments and Product Lines:

• Rezdiffra (resmetirom) achieved blockbuster status with year-to-date net sales exceeding $1 billion less than three years after launch.
• As of September 30, 2026, more than 55,850 patients were on Rezdiffra, nearly doubling from the third quarter of 2025.
• A secondary analysis of the Phase 3 MAESTRO-NASH trial demonstrated Rezdiffra improved histology and MRI-PDFF across common genetic variants associated with MASH progression (PNPLA3, HSD17B13, TM6SF2, MTARC1, and MBOAT7).
• Madrigal plans to initiate the MAESTRO-CSPH Phase 3 trial to enroll more than 2,000 F4c patients, significantly enriched for clinically significant portal hypertension (CSPH), to support validation of noninvasive biomarkers.
• Eighteen abstracts featuring Rezdiffra will be presented at the AASLD Liver Meeting (Nov. 5-9), including 13 based on real-world evidence spanning nearly 12,000 patients.

Market and Competitive Landscape:

• Madrigal aims to be the first and best therapy for well-compensated MASH cirrhosis (F4c).
• MASH is the leading cause of liver transplantation in women and the second leading cause in the U.S., with the fastest-growing indication for liver transplantation in Europe.
• Patients with MASH progressing to cirrhosis face a 42 times higher risk of liver-related mortality compared to those without fibrosis.

Risks and Challenges:

• The press release notes risks including potential regulatory delays or rejections, the possibility of never achieving consistent profitability, and risks associated with clinical trial enrollment and safety events.
• Forward-looking statements highlight uncertainties regarding market demand, competitor trial outcomes, and the ability to service indebtedness or comply with debt covenants.

Management Commentary and Tone:

• CEO Bill Sibold described the quarter as "strong," driven by continued Rezdiffra demand and accelerating market growth.
• Management stated the company is "still early in a rapidly growing market" and emphasized the significant runway ahead.
• Sibold highlighted the objective to "be first and best" in the F4c cirrhosis market and noted that the MAESTRO-CSPH trial is expected to extend competitive advantage.

Other Key Points:

• John C. Reed, M.D., Ph.D., was appointed to the Board of Directors in August; he currently serves as Executive Vice President of Innovative Medicine, Research & Development at Johnson & Johnson.
• The company hosted a conference call on November 3, 2026, at 8 a.m. EST to review results.
• Rezdiffra is the first medication approved by both the FDA and European Commission for the treatment of MASH with moderate to advanced fibrosis (F2 to F3).