Madrigal Pharmaceuticals announced its third-quarter 2024 financial results, highlighting a successful U.S. launch of Rezdiffra (resmetirom) and progress in its clinical development program. The company reported net revenues of $62.2 million for the quarter, marking the first product sales since Rezdiffra's FDA approval in March 2024 for the treatment of nonalcoholic steatohepatitis (NASH)/metabolic dysfunction-associated steatohepatitis (MASH). This early success underscores the urgent need for effective therapies for moderate to advanced NASH/MASH, a condition expected to become the leading cause of liver transplants in the U.S.
Financial Performance
The company's operating expenses for the third quarter totaled $178.5 million, compared to $98.5 million in the same period last year. This increase is primarily attributed to the commercial launch activities for Rezdiffra, including a corresponding increase in headcount, and an increase in stock compensation expense. Research and development expenses were $68.7 million, slightly lower than the $71.0 million reported in the prior year, mainly due to changes in accounting for inventory costs following Rezdiffra's approval.
As of September 30, 2024, Madrigal's cash, cash equivalents, restricted cash, and marketable securities amounted to $1.0 billion, a substantial increase from $634.1 million at the end of 2023.
Clinical Development Update
Madrigal also announced the completion of enrollment in its 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," stated Bill Sibold, Chief Executive Officer of Madrigal.
Market Opportunity and Disease Burden
NASH/MASH is a severe form of nonalcoholic fatty liver disease (NAFLD) and is a leading cause of liver-related mortality. Madrigal estimates that approximately 1.5 million patients have been diagnosed with NASH in the U.S., with about 525,000 having moderate to advanced liver fibrosis. The company is initially focusing on approximately 315,000 diagnosed patients with NASH with moderate to advanced liver fibrosis under the care of liver specialist physicians during the launch of Rezdiffra.
About Rezdiffra (resmetirom)
Rezdiffra (resmetirom) is a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of NASH/MASH. It is currently approved for use in conjunction with diet and exercise for the treatment of adults with noncirrhotic NASH with moderate to advanced liver fibrosis (fibrosis stages 2-3).
