Madrigal Pharmaceuticals MDGL reported fourth-quarter 2024 loss of $2.71 per share, narrower than the Zacks Consensus Estimate of a loss of $4.12. In the year-ago quarter, the company had incurred a loss of $5.68 per share.

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During the quarter, the company generated total revenues of $103.3 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 $101.6 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 hour, in response to the better-than-expected earnings results.

MDGL’s Q4 Results in Detail

In March 2024, the FDA granted accelerated approval to Rezdiffra, making it the first and currently the only approved therapy for 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.

During the quarter, research and development expenses declined 64% to $25.6 million. The decrease can be attributed to reduced clinical study costs and change in accounting for inventory costs following FDA approval of Rezdiffra, partially offset by increases in headcount.

Selling, general and administrative expenses were $141.2 million in the reported quarter compared with $46.5 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 $0.93 billion as of Dec. 31, 2024, compared with $1 billion reported as of Sept. 30, 2024.

In the past three months, Madrigal shares have lost 6.6% compared with the industry’s 8% decline.

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MDGL’s Full-Year Results

In 2024, Madrigal recorded total revenues of $180.1 million, entirely from the sales of Rezdiffra since launch, which beat the Zacks Consensus Estimate of $174.3 million. No revenues were recorded in 2023.

The company’s loss per share in 2024 was $21.9, narrower than the Zacks Consensus Estimate of a loss of $23.5. In 2023, MDGL recorded a loss per share of $20.

MDGL’s Pipeline & Other Updates

Madrigal has also submitted a regulatory filing in the EU seeking approval for Rezdiffra for 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. Topline 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 a separate press release, 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, Consensus and EPS Surprise

Madrigal Pharmaceuticals, Inc. price-consensus-eps-surprise-chart | Madrigal Pharmaceuticals, Inc. Quote

MDGL’s Zacks Rank & Stocks to Consider

Madrigal currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks from the sector are Beam Therapeutics BEAM, BioMarin Pharmaceutical BMRN and Amicus Therapeutics FOLD, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 (Strong Buy) Rank stocks here.

In the past 30 days, Beam Therapeutics’ loss estimates for 2025 have narrowed from $4.29 to $4.27 per share. During the same timeframe, the loss per share for 2026 has improved from $5.16 to $4.54. In the past three months, shares of Beam Therapeutics have gained 19.1%.

BMRN’s earnings beat estimates in three of the trailing four quarters and missed the mark once, delivering an average surprise of 3.92%.

In the past 30 days, estimates for BioMarin Pharmaceutical’s 2025 earnings per share have increased from $4.01 to $4.19. Estimates for 2026 earnings per share have decreased from $5.21 to $5.20 during the same timeframe. In the past three months, BioMarin Pharmaceutical shares have lost 0.9%.

BMRN’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 32.36%.

In the past 30 days, the estimate for Amicus Therapeutics’ 2025 earnings per share has remained constant at 43 cents. The estimate for 2026 earnings per share has deteriorated from 72 cents to 71 cents. In the past three months, shares of Amicus Therapeutics have lost 1.9%.

FOLD’s earnings beat estimates in three of the trailing four quarters and missed once, delivering an average surprise of 45.42%.

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This article originally published on Zacks Investment Research (zacks.com).

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