Madrigal Pharmaceuticals (MDGL) Q1 2026 earnings summary

Executive summary

• Rezdiffra achieved blockbuster status with over $1.1 billion in net sales over the last 12 months, driven by strong demand, rapid market expansion in MASH, and launches in the U.S. and Germany.

• Over 42,250 active patients were on Rezdiffra at the end of Q1 2026, a 2.5x increase year-over-year, reflecting strong physician adoption and high patient demand.

• The addressable U.S. market for F2/F3 MASH patients grew nearly 50% in two years, with diagnosed patients rising from 315,000 to 460,000.

• The company is expanding its pipeline with new siRNA assets, GLP-1 agonists, and DGAT-2 inhibitors, and advancing outcomes trials for broader indications.

• Ongoing Phase 3 trials (MAESTRO-NASH and MAESTRO-NASH OUTCOMES) are expected to support full FDA and EMA approvals and potentially expand Rezdiffra's indications.

Financial highlights

• Q1 2026 net sales reached $311.3 million, up 127% year-over-year, with net loss widening to $94.4 million due to higher R&D and SG&A expenses.

• Operating expenses rose to $404.1 million from $216.6 million year-over-year, including $54.3 million in one-time business development expenses.

• Cost of sales was $26.8 million, primarily reflecting royalties and representing 8.6% of revenue.

• Cash, cash equivalents, and marketable securities totaled $817.9 million as of March 31, 2026, down from $988.6 million at year-end 2025.

• Weighted average shares outstanding were 29.0 million for Q1 2026.

Outlook and guidance

• Expectation of robust net sales growth and steady patient additions for the remainder of 2026, with profitability not anticipated until after 2026.

• Gross-to-net discount anticipated in the mid to high thirties for the rest of 2026.

• Full-year 2026 R&D expenses projected to be similar to 2025, inclusive of one-time payments.

• SG&A expenses will increase in 2026 due to sales force annualization and marketing, with Q2 being the highest quarter.

• Key milestones include outcomes data from MAESTRO-NASH (2028) and MAESTRO-NASH OUTCOMES (2027), and new trial initiations for pipeline assets.