Madrigal Pharmaceuticals MDGL reported first-quarter 2025 loss of $3.32 per share, narrower than the Zacks Consensus Estimate of a loss of $3.62. In the year-ago quarter, the company had incurred a loss of $7.38 per share.
During the quarter, the company generated total revenues of $137.3 million, entirely from product sales of its metabolic dysfunction-associated steatohepatitis (MASH) drug Rezdiffra (resmetirom), which was approved last year. The metric beat the Zacks Consensus Estimate of $114 million. Since this is also the first marketed drug in Madrigal’s portfolio, launched in April 2024, management did not generate any sales in the year-ago period.
MDGL shares are gaining in the premarket hours in response to the better-than-expected earnings results. (Find the latest EPS estimates and surprises on Zacks Earnings Calendar.)
MDGL’s Q1 Results in Detail
In March 2024, the FDA granted accelerated approval to Rezdiffra, making it the first and currently the only approved therapy for the MASH indication. The eligible patient population includes adults with noncirrhotic MASH with moderate to advanced liver fibrosis. The drug’s commercial launch is off to a strong start in the country, driven by early patient demand for the drug. Per Madrigal, more than 17,000 patients are currently receiving Rezdiffra treatment as of March 31, 2025.
During the quarter, research and development expenses declined 38% to $44.2 million. The decrease can be attributed to reduced clinical study costs and a change in accounting for inventory costs following FDA approval of Rezdiffra.
Selling, general and administrative expenses were $167.9 million in the reported quarter compared with $80.8 million in the year-ago period. This exponential rise was on account of increased commercial launch activities for Rezdiffra, including significant increases in headcount and stock compensation expense.
Madrigal had cash, cash equivalents and marketable securities worth $848.1 million as of March 31, 2024, compared with $931.3 million as of Dec. 31, 2024.
Year to Date, Madrigal shares have gained 8.2% against the industry’s 2.2% decline.
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MDGL’s Pipeline & Other Updates
Madrigal has also submitted a regulatory filing in the EU seeking approval for Rezdiffra for the MASH 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 MASH, is ongoing as an outcomes study. The goal is to generate confirmatory 54-month data that could verify the clinical benefits and support the full approval of the drug for the noncirrhotic MASH indication.
In addition to the study, a second phase III outcomes study (MAESTRO-NASH OUTCOMES) is underway, evaluating the progression to liver decompensation events in patients with compensated MASH cirrhosis treated with Rezdiffra compared with placebo. Top-line data is expected in 2027. A positive outcome from this study is also expected to support the full approval of Rezdiffra for noncirrhotic MASH and expand the eligible patient population for Rezdiffra.
The open-label extension (OLE) arm of the MAESTRO-NAFLD-1 study is also currently evaluating the drug in patients with compensated MASH cirrhosis. In February, Madrigal reported positive two-year data from the OLE arm. Per the data readout, a statistically significant mean reduction in liver stiffness of 6.7 kPa was observed in MASH patients upon treatment with Rezdiffra. This figure is also the largest reduction reported in an F4c MASH patient population to date.
Additionally, 51% of patients achieved a ≥25% reduction in liver stiffness, a level linked to a lower risk of end-stage liver disease. Rezdiffra maintained a favorable safety and tolerability profile, with a low discontinuation rate due to adverse events. Detailed data, along with additional findings from the MAESTRO-NAFLD-1 OLE study, are expected to be presented at a future medical conference.
The results reinforce Rezdiffra’s potential benefit for patients with compensated MASH cirrhosis and support the potential success of the ongoing MAESTRO-NASH OUTCOMES study. These ongoing studies demonstrate Madrigal's commitment to establishing the drug as the standard-of-care treatment for MASH.
Madrigal Pharmaceuticals, Inc. Price and Consensus
Madrigal Pharmaceuticals, Inc. Price and Consensus
Madrigal Pharmaceuticals, Inc. price-consensus-chart | Madrigal Pharmaceuticals, Inc. Quote
MDGL’s Zacks Rank & Stocks to Consider
Madrigal currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Bayer BAYRY, ADMA Biologics Inc. ADMA and Beam Therapeutics Inc. BEAM, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 60 days, estimates for Bayer’s earnings per share have increased from $1.14 to $1.19 for 2025. During the same time, earnings per share have increased from $1.23 to $1.28 for 2026. Year to date, shares of Bayer have gained 35%.
BAYRY’s earnings matched estimates in two of the trailing three quarters while missing the same on the remaining occasion, the average negative surprise being 19.61%.
In the past 60 days, estimates for ADMA Biologics’ earnings per share have increased from 69 cents to 71 cents for 2025. During the same time, earnings per share estimates for 2026 have increased from 87 cents to 93 cents. Year to date, shares of ADMA have rallied 38.8%.
ADMA’s earnings beat estimates in three of the trailing four quarters while missing the same on the remaining occasion, the average surprise being 32.80%.
In the past 60 days, estimates for Beam Therapeutics' loss per share have narrowed from $4.45 to $4.27 for 2025. During the same time, loss per share estimates for 2026 have narrowed from $4.94 to $4.80. Year to date, shares of BEAM have lost 19.6%.
BEAM’s earnings beat estimates in three of the trailing four quarters while missing the same on the remaining occasion, the average surprise being 3.92%.
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