We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Madrigal (MDGL) Tops on Q2 Earnings, NASH Drug Drives Top Line
Read MoreHide Full Article
Madrigal Pharmaceuticals (MDGL - Free Report) reported a loss of $7.10 per share in second-quarter 2024, narrower than the Zacks Consensus Estimate of a loss of $7.55. In the year-ago quarter, the company reported a loss of $4.69.
During the quarter, the company generated total revenues of $14.6 million — entirely from product sales of its recently approved nonalcoholic steatohepatitis (NASH) drug Rezdiffra, which was commercially launched this April. The metric beat the Zacks Consensus Estimate of $3.8 million. Since this is also the first marketed drug in Madrigal’s portfolio, management did not generate any sales in the year-ago period.
Quarter in Detail
This March, the FDA granted accelerated approval to Rezdiffra, making it the first and currently the only-approved therapy for NASH indication. 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 Jun 30, coverage for Rezdiffra is in place for more than 50% 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 increased 4% to $71.1 million. This uptick was primarily due to an increase related to the timing of manufacturing, headcount and stock compensation expenses.
Selling, general and administrative expenses were $105.4 million in the reported quarter compared with $17.8 million in the year-ago period. This exponential rise was on account of increases in commercial preparation activities for the launch of Rezdiffra, including significant commercial headcount expansion and stock compensation expense.
Madrigal had cash, cash equivalents and marketable securities worth $1.1 billion as of Jun 30, 2024, in line with the balance reported as of Mar 31, 2024.
Year to date, Madrigal’s shares have risen 15.2% against the industry’s 4.5% fall.
Image Source: Zacks Investment Research
Pipeline & Other Updates
Madrigal also submitted a regulatory filing in the European Union, which seeks approval for Rezdiffra in 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 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 in 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 a placebo. Madrigal is also conducting a third phase III open-label extension (OLE) study to further evaluate the safety and efficacy of Rezdiffra for the treatment of NASH.
These studies aim to broaden the eligible patient population, potentially increasing Rezdiffra's market and boosting sales. These ongoing studies demonstrate Madrigal's commitment to establishing the drug as the standard-of-care treatment for NASH.
Madrigal currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the healthcare sector are Entrada Therapeutics (TRDA - Free Report) , Immatics (IMTX - Free Report) and Halozyme Therapeutics (HALO - Free Report) . While Entrada and Immatics each sport a Zacks Rank #1 (Strong Buy), Halozyme carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Entrada Therapeutics’ 2024 loss per share have improved from 14 cents to 13 cents. Estimates for 2025 have improved from $3.44 to $3.21 during the same period. Year to date, shares of Entrada Therapeutics have lost 2.7%.
Earnings of Entrada Therapeuticsbeat estimates in two of the last four quarters while missing the mark on two other occasions. Entrada delivered a four-quarter average earnings surprise of 42.18%.
In the past 60 days, the loss per share estimates for Immatics have improved from $1.26 to $1.25 for 2024. During the same period, loss estimates for 2025 have improved from $1.49 to $1.41. Year to date, shares of IMTX have risen 6.5%.
Earnings of Immatics beat estimates in three of the last four quarters while meeting the mark on one occasion, delivering a four-quarter average earnings surprise of 32.57%.
In the past 60 days, the Zacks Consensus Estimate for Halozyme Therapeutics’ 2024 earnings has risen from $3.88 per share to $3.90. For 2025, earnings estimates have increased from $4.76 to $4.81 in the past 60 days. Year to date, shares of HALO have surged 40.5%.
Earnings of Halozyme beat estimates in three of the last four quarters while meeting the mark on one occasion, delivering a four-quarter average earnings surprise of 9.20%.
See More Zacks Research for These Tickers
Pick one free report - opportunity may be withdrawn at any time
Image: Bigstock
Madrigal (MDGL) Tops on Q2 Earnings, NASH Drug Drives Top Line
Madrigal Pharmaceuticals (MDGL - Free Report) reported a loss of $7.10 per share in second-quarter 2024, narrower than the Zacks Consensus Estimate of a loss of $7.55. In the year-ago quarter, the company reported a loss of $4.69.
During the quarter, the company generated total revenues of $14.6 million — entirely from product sales of its recently approved nonalcoholic steatohepatitis (NASH) drug Rezdiffra, which was commercially launched this April. The metric beat the Zacks Consensus Estimate of $3.8 million. Since this is also the first marketed drug in Madrigal’s portfolio, management did not generate any sales in the year-ago period.
Quarter in Detail
This March, the FDA granted accelerated approval to Rezdiffra, making it the first and currently the only-approved therapy for NASH indication. 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 Jun 30, coverage for Rezdiffra is in place for more than 50% 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 increased 4% to $71.1 million. This uptick was primarily due to an increase related to the timing of manufacturing, headcount and stock compensation expenses.
Selling, general and administrative expenses were $105.4 million in the reported quarter compared with $17.8 million in the year-ago period. This exponential rise was on account of increases in commercial preparation activities for the launch of Rezdiffra, including significant commercial headcount expansion and stock compensation expense.
Madrigal had cash, cash equivalents and marketable securities worth $1.1 billion as of Jun 30, 2024, in line with the balance reported as of Mar 31, 2024.
Year to date, Madrigal’s shares have risen 15.2% against the industry’s 4.5% fall.
Image Source: Zacks Investment Research
Pipeline & Other Updates
Madrigal also submitted a regulatory filing in the European Union, which seeks approval for Rezdiffra in 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 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 in 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 a placebo. Madrigal is also conducting a third phase III open-label extension (OLE) study to further evaluate the safety and efficacy of Rezdiffra for the treatment of NASH.
These studies aim to broaden the eligible patient population, potentially increasing Rezdiffra's market and boosting sales. These ongoing studies demonstrate Madrigal's commitment to establishing the drug as the standard-of-care treatment for NASH.
Madrigal Pharmaceuticals, Inc. Price
Madrigal Pharmaceuticals, Inc. price | Madrigal Pharmaceuticals, Inc. Quote
Zacks Rank & Key Picks
Madrigal currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the healthcare sector are Entrada Therapeutics (TRDA - Free Report) , Immatics (IMTX - Free Report) and Halozyme Therapeutics (HALO - Free Report) . While Entrada and Immatics each sport a Zacks Rank #1 (Strong Buy), Halozyme carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Entrada Therapeutics’ 2024 loss per share have improved from 14 cents to 13 cents. Estimates for 2025 have improved from $3.44 to $3.21 during the same period. Year to date, shares of Entrada Therapeutics have lost 2.7%.
Earnings of Entrada Therapeuticsbeat estimates in two of the last four quarters while missing the mark on two other occasions. Entrada delivered a four-quarter average earnings surprise of 42.18%.
In the past 60 days, the loss per share estimates for Immatics have improved from $1.26 to $1.25 for 2024. During the same period, loss estimates for 2025 have improved from $1.49 to $1.41. Year to date, shares of IMTX have risen 6.5%.
Earnings of Immatics beat estimates in three of the last four quarters while meeting the mark on one occasion, delivering a four-quarter average earnings surprise of 32.57%.
In the past 60 days, the Zacks Consensus Estimate for Halozyme Therapeutics’ 2024 earnings has risen from $3.88 per share to $3.90. For 2025, earnings estimates have increased from $4.76 to $4.81 in the past 60 days. Year to date, shares of HALO have surged 40.5%.
Earnings of Halozyme beat estimates in three of the last four quarters while meeting the mark on one occasion, delivering a four-quarter average earnings surprise of 9.20%.