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Madrigal Q3 Earnings Beat, NASH Drug Sales Drive Top Line, Stock Up
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Madrigal Pharmaceuticals (MDGL - Free Report) 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.
Find the latest EPS estimates and surprises on Zacks Earnings Calendar.
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.
Image Source: Zacks Investment Research
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.
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 third 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. Madrigal is also conducting a third phase III open-label extension study to further evaluate the safety and efficacy of Rezdiffra for the treatment of NASH.
These ongoing studies demonstrate Madrigal's commitment to establishing the drug as the standard-of-care treatment for NASH.
Madrigal Pharmaceuticals, Inc. Price and Consensus
Estimates for Bayer’s 2024 earnings per share (EPS) have increased from $1.37 to $1.38 over the past 60 days, while the same for 2025 have remained constant at $1.44. BAYRY’s shares have lost 26.7% year to date.
Allogene Therapeutics’ loss estimates have remained constant at $1.41 per share for 2024 over the past 60 days, while that for 2025 has narrowed from $1.46 to $1.45 per share. ALLO’s shares have lost 20.4% year to date.
Allogene Therapeutics’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 11.82%.
Novartis’ EPS estimates have risen from $7.48 to $7.56 per share for 2024 over the past 60 days, while that for 2025 has increased from $8.29 to $8.33. NVS’ shares have risen 7.4% year to date.
Novartis’ earnings beat estimates in three of the trailing four quarters and missed the same in one, delivering an average surprise of 2.22%.
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Madrigal Q3 Earnings Beat, NASH Drug Sales Drive Top Line, Stock Up
Madrigal Pharmaceuticals (MDGL - Free Report) 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.
Find the latest EPS estimates and surprises on Zacks Earnings Calendar.
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.
Image Source: Zacks Investment Research
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.
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 third 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. Madrigal is also conducting a third phase III open-label extension study to further evaluate the safety and efficacy of Rezdiffra for the treatment of NASH.
These ongoing studies demonstrate Madrigal's commitment to establishing the drug as the standard-of-care treatment for NASH.
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 pharma stocks are Bayer (BAYRY - Free Report) , Allogene Therapeutics (ALLO - Free Report) and Novartis (NVS - Free Report) , 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.
Estimates for Bayer’s 2024 earnings per share (EPS) have increased from $1.37 to $1.38 over the past 60 days, while the same for 2025 have remained constant at $1.44. BAYRY’s shares have lost 26.7% year to date.
Allogene Therapeutics’ loss estimates have remained constant at $1.41 per share for 2024 over the past 60 days, while that for 2025 has narrowed from $1.46 to $1.45 per share. ALLO’s shares have lost 20.4% year to date.
Allogene Therapeutics’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 11.82%.
Novartis’ EPS estimates have risen from $7.48 to $7.56 per share for 2024 over the past 60 days, while that for 2025 has increased from $8.29 to $8.33. NVS’ shares have risen 7.4% year to date.
Novartis’ earnings beat estimates in three of the trailing four quarters and missed the same in one, delivering an average surprise of 2.22%.