Madrigal’s MASH Drug Rezdiffra Surpasses Q2 Sales Estimates

Q2 Earnings:
Madrigal Pharmaceuticals (MDGL) reported a loss of $7.10 per share in Q2 2024, narrower than the Zacks Consensus Estimate of $7.55.

Revenue:
The company generated $14.6 million in total revenues, entirely from product sales of Rezdiffra, surpassing the Zacks Consensus Estimate of $3.8 million.

Commercial Launch:
Rezdiffra, the first and only approved therapy for NASH, was commercially launched in April 2024 and has seen strong early demand.

FDA Approval:
The FDA granted accelerated approval to Rezdiffra in March 2024, with continued approval contingent on long-term safety and efficacy data from ongoing phase III studies.

Market Coverage:
As of June 30, 2024, coverage for Rezdiffra is in place for more than 50% of commercial lives covered by health insurance in the United States.

R&D and SG&A Expenses:
Research and development expenses increased 4% to $71.1 million, while selling, general, and administrative expenses rose significantly to $105.4 million due to commercial preparation activities.

Cash Position:
Madrigal had $1.1 billion in cash, cash equivalents, and marketable securities as of June 30, 2024.

Stock Performance:
Madrigal's shares have risen 15.2% year-to-date, outperforming the industry's 4.5% decline.

European Regulatory Filing:
Madrigal submitted a regulatory filing in the European Union seeking approval for Rezdiffra in NASH indication, with a final decision expected in mid-2025.

Ongoing Studies:
Madrigal is conducting phase III outcomes studies to generate confirmatory data for Rezdiffra's full approval and to broaden its eligible patient population.