MADRIGAL PHARMACEUTICALS Q2 FY26 earnings call MDGL

Rezdiffra continues to demonstrate strong commercial execution, with Q2 FY26 net sales reaching $364.3 million, a 71% year-over-year increase. The company ended the quarter with over 49,000 active patients on Rezdiffra, more than double the prior year, and surpassed the 50,000 patient milestone in early Q3. This performance reinforces Rezdiffra's position as a foundational therapy in MASH, tracking in line with or exceeding best-in-class specialty launches and contributing to nearly $1.3 billion in trailing 12-month net sales.

The U.S. addressable MASH market for diagnosed F2/F3 patients has grown significantly, increasing by nearly 50% from 315,000 at year-end 2023 to 460,000 at year-end 2025. This growth is driven by increased disease awareness, diagnosis rates, and specialist referrals. Madrigal anticipates the MASH market will continue to expand at a double-digit pace for the foreseeable future, comparing its evolution to other large chronic disease markets like rheumatoid arthritis and IBD, which now support numerous products and billions in annual sales.

Madrigal is building on Rezdiffra's foundation by developing an industry-leading MASH pipeline with over 10 programs, including 4 clinical-stage assets. The strategy focuses on complementary mechanisms to enhance efficacy, broaden patient reach, and define next-generation MASH therapies. Planned Phase II trials in 2027 include combinations of resmetirom with MGL-2086 (oral GLP-1), Ervogastat (DGAT-2 inhibitor), and a PNPLA3 siRNA, aiming to potentiate resmetirom's antifibrotic effects and target specific patient subgroups.

The company highlights the significant unmet need in well-compensated MASH cirrhosis (F4c), representing an untapped market of approximately 245,000 U.S. patients. The ongoing event-driven MAESTRO outcome trial in F4c is expected to read out in 2027 and, if positive, could support label expansion and full approval across F2 to F4c. Early data from the MAESTRO-NAFLD-1 trial using the Anticipate NASH model suggests resmetirom's potential to delay disease progression and improve long-term outcomes in F4c patients.

Madrigal has strategically strengthened Rezdiffra's intellectual property estate. Following the pivotal 2045 F2-F3 patent secured last year, the company announced 3 additional patents in July. Two of these patents reinforce F2-F3 protection by covering important safety information in the label, while one supports the potential F4c indication. These additions extend and solidify the long-term value and protection of the Rezdiffra franchise.

Rezdiffra demonstrates consistent efficacy across diverse MASH patient subgroups, including those with varying fibrosis stages, diabetes status, BMI, and genetic backgrounds, as shown in MAESTRO-NASH data. Real-world evidence from a large gastroenterology practice indicated nearly half of patients achieved at least a 25% reduction in liver stiffness over approximately 9 months. Additionally, secondary analyses showed significant reductions in cardiometabolic risk factors like ApoB, Lp(a), and LDL, suggesting broader patient benefits.

Madrigal ended Q2 FY26 with $838.9 million in cash, cash equivalents, restricted cash, and marketable securities. While the company reported a net loss of $57.9 million, it continues to invest significantly in R&D ($91.2 million) and SG&A ($289.4 million) to support the Rezdiffra launch and pipeline advancement. The company expects full-year 2026 R&D expenses to be similar to 2025 and SG&A expenses to increase, reflecting its commitment to long-term growth and market leadership.