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Third-quarter 2024 net sales of $62.2 million
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Rezdiffra™ (resmetirom) coverage goal achieved early, with more than 80 percent of commercial lives covered; less than 5 percent of Rezdiffra-covered lives require biopsy
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Completed enrollment of clinical outcomes study of Rezdiffra in patients with compensated NASH/MASH cirrhosis
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Reports cash, cash equivalents, restricted cash and marketable securities of $1.0 billion at September 30, 2024
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Company to host conference call today, October 31, 2024, at 8 a.m. EDT
CONSHOHOCKEN, Pa., Oct. 31, 2024 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), a biopharmaceutical company focused on delivering novel therapeutics for nonalcoholic steatohepatitis (NASH)/metabolic dysfunction-associated steatohepatitis (MASH), today reports third-quarter 2024 financial results and provides corporate updates.
Bill Sibold, Chief Executive Officer of Madrigal, stated, “Our U.S. launch of Rezdiffra is progressing exceptionally well driven by the outstanding execution of our team. Growing adoption by prescribers, broader payer coverage and an increasing number of patients on therapy each contributed to the strong performance. This early success highlights the critical need for effective treatments for moderate to advanced NASH/MASH, which is expected to become the leading cause of liver transplants in the U.S.”
Sibold continued, “We’ve also advanced our pipeline, completing enrollment in our clinical outcomes study for patients with compensated NASH/MASH cirrhosis. This milestone is key, as positive results could lead to full approval and a broader indication for Rezdiffra.”
Third Quarter and Recent Corporate Updates
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Rezdiffra U.S. launch update
Madrigal is continuing to execute the U.S. launch of Rezdiffra by educating healthcare providers and patients on the risks of NASH and the potential clinical benefits of Rezdiffra. The Company is also supporting the creation of care pathways for patients at physician offices, driving breadth and depth of Rezdiffra prescribers, engaging with payers to increase Rezdiffra coverage and supporting patient access to therapy.
As of September 30, coverage for Rezdiffra was in place for more than 80 percent of commercial lives covered by health insurance in the U.S.The Company achieved its 80 percent commercial coverage goal one quarter ahead of schedule. Less than 5 percent of Rezdiffra-covered lives require biopsy for diagnosis and instead accept noninvasive tests, or NITs, in line with current standard of care.
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Completed enrollment in MAESTRO-NASH OUTCOMES trial
In October, the Company announced that it completed enrollment in its MAESTRO-NASH OUTCOMES trial evaluating Rezdiffra for the treatment of patients with compensated NASH cirrhosis. Positive results from this study could result in Rezdiffra becoming the first medicine approved for patients with compensated cirrhosis, expanding its eligible patient population, and could support full approval in noncirrhotic NASH.
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Appointed Dr. Michael Charlton to Senior Vice President of Clinical Development
In October, the Company announced the appointment of Michael Charlton, M.B.B.S., F.R.C.P., as Senior Vice President, Clinical Development. Dr. Charlton has more than 30 years of leadership experience in hepatology, gastroenterology and liver transplantation, with an expertise in NASH. His extensive research in the pathophysiology and treatment of NASH has resulted in over 200 publications, making him a key figure in both clinical and academic hepatology.
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Rezdiffra quality of life data published in journal of Hepatology
In September, positive health-related quality of life data from the Phase 3 MAESTRO-NASH trial of Rezdiffra was published in the journal Hepatology. Results demonstrated that patients with MASH/NASH treated with Rezdiffra experienced clinically meaningful and statistically significant improvements in emotional well-being and health distress.
Madrigal to have strong presence at upcoming AASLD Liver Meeting Madrigal expects to have a significant presence at the upcoming American Association for the Study of Liver Diseases (AASLD) Liver Meeting taking place
Nov. 15 -19 in San Diego. More than ten Madrigal abstracts have been accepted for presentation at the meeting, including two oral presentations of new analyses from the Phase 3 MAESTRO-NASH study of Rezdiffra.
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Driving future growth through European expansion
Rezdiffra is currently under evaluation with the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) and has the potential to become the first therapy for patients with NASH/MASH liver fibrosis to receive approval in Europe.
The Company plans to directly commercialize resmetirom in Europe in the event of a positive decision from the EMA on the Marketing Authorization Application (MAA). The EMA’s decision is expected mid-year 2025.
Third-Quarter 2024 Financial Results
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Total revenues: The Company generated third-quarter 2024 net revenues of $62.2 million. No product sales were recognized during the comparable prior year period.
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Operating Expenses: Third-quarter 2024 operating expenses were $178.5 million, compared to $98.5 million in the comparable prior year period.
Cost of sales: Third-quarter 2024 cost of sales were $2.2 million. Cost of sales were not recognized during the comparable prior year period given that no product sales were recorded.
R&D Expense: Third-quarter 2024 R&D expense was $68.7 million, compared to $71.0 million in the comparable prior year period. The decrease was primarily due to the change in accounting for inventory costs following FDA approval of Rezdiffra in March 2024, partially offset by increases in headcount.
SG&A Expense: Third-quarter 2024 SG&A expense was $107.6 million, compared to $27.6 million in the comparable prior year period. The increase was primarily due to the commercial launch activities for Rezdiffra, including a corresponding increase in headcount, and an increase in stock compensation expense.
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Interest Income: Third-quarter 2024 interest income was $13.0 million, compared to $3.3 million in the comparable prior year period. The increase in interest income was due primarily to higher principal balances and interest rates in 2024.
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Interest Expense: Third-quarter 2024 interest expense was $3.7 million, compared to $3.5 million in the comparable prior year period. The increase in interest expense was primarily the result of a higher average outstanding principal balance during the period under the Company’s loan facility.
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Cash, Cash Equivalents, Restricted Cash and Marketable Securities: As of September 30, 2024, Madrigal had cash, cash equivalents, restricted cash and marketable securities of $1.0 billion, compared to $634.1 million at December 31, 2023.
Conference Call and Webcast
At 8 a.m. EDT today, October 31, 2024, the Company will host a webcast to review its financial and operating results and provide a general business update. To access the webcast, please visit the investor relations section of the Madrigal website or click here to register. An archived webcast will be available on the Madrigal website following the event.
About NASH
Nonalcoholic steatohepatitis (NASH) is a more advanced form of nonalcoholic fatty liver disease (NAFLD). NASH is a leading cause of liver-related mortality and an increasing burden on healthcare systems globally. Additionally, patients with NASH, especially those with more advanced metabolic risk factors (hypertension, concomitant type 2 diabetes), are at increased risk for adverse cardiovascular events and increased morbidity and mortality.
Once patients progress to NASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis), the risk of adverse liver outcomes increases dramatically. NASH is expected to become the leading cause of liver transplants in the U.S.
Madrigal estimates that approximately 1.5 million patients have been diagnosed with NASH in the U.S., of which approximately 525,000 have NASH with moderate to advanced liver fibrosis. Madrigal is focusing on approximately 315,000 diagnosed patients with NASH with moderate to advanced liver fibrosis under the care of the liver specialist physicians during the launch of Rezdiffra.
NASH is also known as metabolic dysfunction associated steatohepatitis (MASH). In 2023, global liver disease medical societies and patient groups came together to rename the disease, with the goal of establishing an affirmative, non-stigmatizing name and diagnosis. Nonalcoholic fatty liver disease (NAFLD) was renamed metabolic dysfunction-associated steatotic liver disease (MASLD); NASH was renamed MASH; and an overarching term, steatotic liver disease (SLD), was established to capture multiple types of liver diseases associated with fat buildup in the liver. In addition to liver disease, patients with MASH have at least one related comorbid condition (e.g., obesity, hypertension, dyslipidemia, or type 2 diabetes).
About Madrigal Pharmaceuticals
Madrigal Pharmaceuticals, Inc. (Nasdaq: MDGL) is a biopharmaceutical company focused on delivering therapeutics for nonalcoholic steatohepatitis (NASH), a liver disease with high unmet medical need. Madrigal’s medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of NASH.