Madrigal Pharmaceuticals MDGL reported third-quarter 2024 loss of $4.92 per share, narrower than the Zacks Consensus Estimate of a loss of $6.94 per share. In the year-ago quarter, the company reported a loss of $5.34 per share.

During the quarter, the company generated total revenues of $62.2 million — entirely from product sales of its recently approved nonalcoholic steatohepatitis (NASH) drug Rezdiffra (resmetirom), which was commercially launched this April. The metric beat the Zacks Consensus Estimate of $33 million. Since this is also the first marketed drug in Madrigal’s portfolio, management did not generate any sales in the year-ago period. Shares of Madrigal gained 20.1% on Thursday, in response to the better-than-expected results.

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MDGL’s Q3 Results in Detail

In March 2024, the FDA granted accelerated approval to Rezdiffra, making it the first and currently the only approved therapy for NASH indication. The eligible patient population includes adults with noncirrhotic NASH with moderate to advanced liver fibrosis. Per management, the drug’s commercial launch is off to a strong start in the country, driven by early patient demand for the drug. As of Sept. 30, coverage for Rezdiffra is in place for more than 80% of commercial lives covered by health insurance in the United States and less than 5% of Rezdiffra-covered lives require biopsy.

During the quarter, research and development (R&D) expenses declined 3% to $68.7 million. The decrease can be attributed to the change in accounting for inventory costs following FDA approval of Rezdiffra, partially offset by increases in headcount.

Selling, general and administrative expenses were $107.6 million in the reported quarter compared with $27.6 million in the year-ago period. This exponential rise was on account of increased commercial launch activities for Rezdiffra, including significant commercial headcount expansion and stock compensation expense.

Madrigal had cash, cash equivalents and marketable securities worth $1 billion as of Sept 30, 2024, compared with $1.1 billion reported as of June 30, 2024.

Year to date, Madrigal shares have risen 12.1% against the industry’s 5.7% decline.

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MDGL’s Pipeline & Other Updates

Madrigal also submitted a regulatory filing in the EU, which seeks approval for Rezdiffra for NASH indication. A final decision is expected in mid-2025.

As the FDA approved Rezdiffra under the accelerated pathway, the continued approval will be based on promising long-term safety and efficacy data from the pivotal phase III MAESTRO-NASH biopsy study. This late-stage study, which provided the data for the drug's accelerated approval for NASH, is ongoing as an outcomes study. The goal is to generate confirmatory data that could verify the clinical benefits and support the full approval of the drug for the noncirrhotic NASH indication.