Madrigal Pharmaceuticals (MDGL) 44th Annual J.P. Morgan Healthcare Conference summary

Strategic growth and market leadership

• Achieved rapid commercial success with Rezdiffra, annualizing over $1 billion in sales within six quarters and over 29,500 active patients by Q3 2025, with more than 10,000 prescribers.

• Secured strong first-line market access for 2026 through national payer contracts, with no step-edit requirements and improved payer criteria.

• Less than 10% market penetration among diagnosed F2/F3 patients (315,000), indicating significant room for growth.

• Expansion into F4c (compensated MASH cirrhosis) could double the addressable U.S. patient population (~245,000), with outcomes data expected in 2027.

• International expansion initiated with a launch in Germany, with further ex-US growth expected to scale gradually; new U.S. patent extends value to 2045.

Pipeline development and innovation

• Focused on building a leading MASH pipeline through targeted business development and internal innovation, leveraging expertise in metabolic and liver diseases.

• Four R&D pillars: delivering transformational outcomes data, advancing combination therapies, exploring new modalities, and executing capital-efficient trials.

• Two new deals: licensed an oral GLP-1 agonist (MGL-2086) and a DGAT2 inhibitor (ervogastat), both aimed at combination strategies to enhance efficacy and tolerability.

• Phase I study for oral GLP-1 to begin in Q2 2026, with combination development planned for 2027; DGAT2 and resmetirone drug-drug interaction study also set for 2026.

• Pipeline includes one new phase II, two ongoing phase III trials, and three clinical-stage assets, supporting both short- and long-term growth.

Commercial and financial outlook

• SG&A spend focused on supporting top-line growth and pipeline development, with R&D ramping up as new programs advance.

• Profitability expected as top-line growth outpaces expenses, though near-term focus remains on business advancement rather than immediate profits.

• Gross-to-net expected to rise to the high 30% range in 2026 due to commercial contracting, but robust net revenue growth anticipated.

• Growth in 2026 driven primarily by increased depth of prescribing among existing prescribers, with significant untapped patient potential.

• U.S. market remains the primary focus, with ex-U.S. opportunities approached pragmatically to avoid compromising domestic performance.