Madrigal Pharmaceuticals (MDGL) Q4 2025 earnings summary

Executive summary

• Achieved $958.4M in full-year 2025 net sales for Rezdiffra, with $321.1M in Q4 and over 36,250 patients treated by year-end, establishing it as the foundational therapy in MASH and driving rapid market adoption.

• Achieved landmark FDA approval for Rezdiffra in March 2024 and launched in Germany after EC approval, making it the first and only approved MASH therapy in the US and EU.

• Expanded pipeline to over 10 programs, including oral GLP-1, late-stage DGAT-2 inhibitor, and siRNA targets, all designed for combination with Rezdiffra.

• Extended Rezdiffra's patent exclusivity to 2045 and initiated ex-US rollout, though international contribution remains negligible for now.

• Secured up to $500M in senior secured credit to advance pipeline and maintain strong liquidity.

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 Q4 2025 with $988.6M in cash, cash equivalents, restricted cash, and marketable securities.

• 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.

• Gross margin improved as cost of sales rose to $56.1M on $958.4M revenue.

Outlook and guidance

• Robust net sales growth expected in 2026 despite higher gross to net and typical Q1 insurance dynamics, with global expansion beginning in Germany.

• Anticipate continued double-digit market growth and steady patient additions for years to come.

• F4c indication could double Rezdiffra’s 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.

• SG&A expenses expected to increase in 2026 to support launch and long-term growth; R&D expenses to remain stable.