Madrigal Pharmaceuticals (MDGL) Q4 2025 earnings summary

Executive summary

• Achieved $958.4M in net sales for Rezdiffra in FY25, with $321.1M in Q4, establishing it as the foundational therapy in MASH and driving rapid market adoption and robust growth in a rapidly expanding market.

• Expanded patient base to over 36,250 by year-end, with less than 12% penetration in the F2/F3 MASH target market, indicating significant growth potential.

• Extended Rezdiffra's patent exclusivity to 2045 and initiated ex-US rollout, starting in Germany after EC approval, while maintaining US as the core business.

• Built a diversified pipeline with over 10 programs, including oral GLP-1, DGAT-2 inhibitor, and siRNA assets, with IND-enabling activities and clinical trials planned for 2026-2027.

• Positioned for long-term leadership in MASH, with a strategy focused on combination regimens, expanding into new patient populations, and global expansion.

Financial highlights

• Q4 2025 net sales reached $321.1M, more than tripling the prior year quarter; full-year 2025 net sales totaled $958.4M, reflecting exceptional launch performance.

• Operating expenses for Q4 and full-year 2025 were $380.7M and $1,258.5M, with a Q4 net loss of $58.6M and full-year net loss of $288.3M.

• Ended 2025 with $988.6M in cash, cash equivalents, restricted cash, and marketable securities, supporting ongoing operations and R&D.

• R&D expenses for 2025 were $388.5M, with significant upfront payments for pipeline expansion; SG&A expenses were $813.8M.

• Gross to net impact averaged at the low end of the 20%-30% range for 2025; expected to rise to the high 30% range in 2026 due to new payer contracts.

Outlook and guidance

• Anticipates robust net sales growth in 2026, driven by broader first-line access, increased disease awareness, and global expansion, despite higher gross to net impact and typical Q1 seasonality.

• Expects continued steady patient additions and strong business fundamentals, with consensus estimates for 2026 reflecting confidence in ongoing growth.

• R&D expenses projected to remain stable in 2026, while SG&A is expected to increase to support further launch and pipeline activities.

• F4c indication could double commercial opportunity, with outcomes data expected in 2027.

• Plans to initiate IND-enabling activities for siRNA candidates and begin clinical trials for oral GLP-1 in 2026.