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Shares of Madrigal Pharmaceuticals MDGL lost 9.7% on Tuesday as the investors were not impressed by its preliminary fourth-quarter and full-year 2024 results. The company’s top line comprises only its product revenues. Madrigal’s commercial portfolio has one marketed drug, Rezdiffra (resmetirom), a once-daily, oral and liver-directed THR-β agonist.
Rezdiffra gained the FDA’s accelerated approval in March 2024 for adult patients with nonalcoholic steatohepatitis (NASH). Subsequently, the drug became the first and only FDA-approved therapy that targets the underlying causes of NASH.
In the past three months, Madrigal shares have gained 27.1% against the industry’s 11.7% decline.
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MDGL’s Preliminary Q4 & FY24 Results
Madrigal reported preliminary fourth-quarter 2024 revenues from Rezdiffra sales in the $100-$103 million range.
For the full year, MDGL announced preliminary revenues in the $177-$180 million band from the drug’s sales since its launch in April 2024. Per the company, more than 11,800 patients are on Rezdiffra treatment as of year-end 2024.
Preliminary report suggests that Madrigal’s year-end 2024 cash, cash equivalents, restricted cash and marketable securities approximately amount to $931 million.
MDGL’s Pipeline Update
A regulatory filing, seeking approval for Rezdiffra for the same indication is currently under review in the EU. A final decision is expected in mid-2025. Subject to approval, Madrigal plans to initiate a country-by-country launch of the drug in the EU starting with Germany in the second half of 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 Rezdiffra for the noncirrhotic NASH indication.
In addition to the MAESTRO-NASH study, a second phase III outcomes study is underway, evaluating the progression to liver decompensation events in patients with well-compensated NASH cirrhosis treated with Rezdiffra compared with placebo. This second outcomes study completed enrolling patients during the last reported quarter. Positive results from this study could make Rezdiffra the first approved treatment for patients with compensated cirrhosis, broadening its eligible patient group and potentially supporting full approval for noncirrhotic NASH.