Madrigal Pharmaceuticals Announces Q2 2024 Financial Results and Corporate Updates

Madrigal Pharmaceuticals, Inc. has announced its second-quarter 2024 financial results, highlighting significant progress in the launch and expansion of its novel therapeutic, Rezdiffra™ (resmetirom), aimed at treating nonalcoholic steatohepatitis (NASH) and metabolic dysfunction-associated steatohepatitis (MASH).

Chief Executive Officer Bill Sibold expressed optimism regarding the U.S. launch of Rezdiffra, noting the strong initial demand and enthusiastic response from both physicians and patients. The company’s efforts to educate healthcare providers and establish patient care pathways are seen as crucial for future growth. Sibold emphasized the importance of NASH treatment, pointing out that it is a leading cause of liver transplants among women in the U.S. He also highlighted data presented at the European Association for the Study of the Liver (EASL) Congress, which demonstrated Rezdiffra’s 91% efficacy in halting or reversing liver stiffness, reinforcing its efficacy profile. New EASL guidelines now recommend Rezdiffra as the foundational therapy for NASH.

Madrigal is actively executing its U.S. launch strategy, with Rezdiffra now available as a once-daily oral medication targeting the underlying causes of NASH since April 9, 2024. The company has made significant strides in securing insurance coverage, with more than 50% of commercially insured lives in the U.S. covered as of June 30, 2024, and aims to reach 80% by year-end. Less than 5% of those covered require a biopsy for diagnosis, aligning with current standards that favor noninvasive tests.

Looking to the future, Madrigal plans to expand Rezdiffra’s reach to Europe following expected regulatory approval from the European Medicines Agency (EMA) in mid-2025. If approved, Rezdiffra could become the first therapy for NASH/MASH with liver fibrosis in Europe. The company intends to directly commercialize the drug in the European market.

Recent updates also include new clinical practice guidelines published in the Journal of Hepatology, recommending Rezdiffra as the first-line therapy for F2/F3 NASH/MASH patients. This endorsement stems from Rezdiffra's positive results in a Phase 3 clinical trial. Additionally, the Journal of Clinical Gastroenterology and Hepatology published practical guidance for the use of Rezdiffra, supporting its adoption in clinical settings.

At the EASL Congress in June, Madrigal presented multiple abstracts, including a late-breaking oral presentation that used AI technology to provide deeper insights from the Phase 3 MAESTRO-NASH study. New analyses of noninvasive test data showed a durable treatment response over three years, with 91% of patients experiencing improvement or stabilization in liver stiffness. The company also presented data on Rezdiffra’s efficacy in patients with probable metabolic dysfunction and alcohol-associated liver disease (MetALD), showing similar rates of fibrosis improvement and steatohepatitis resolution as seen in the NASH population.

Madrigal also reported two health economics outcomes research studies in Medicare patients, concluding that NASH patients face higher risks of disease progression and associated costs, especially in advanced stages. The studies suggested that effective interventions could reduce both morbidity and mortality, providing economic benefits.

Financially, Madrigal reported second-quarter 2024 net sales of $14.6 million, primarily from Rezdiffra. The cost of sales for the quarter was $0.6 million. Operating expenses totaled $177.2 million, up from $86.5 million in the same period last year, driven by increased R&D and SG&A expenses related to the launch of Rezdiffra. The company’s cash, cash equivalents, restricted cash, and marketable securities totaled $1.1 billion as of June 30, 2024, boosted by net proceeds from a public offering in March 2024.

In summary, Madrigal Pharmaceuticals is making significant strides in the treatment of NASH with the successful U.S. launch of Rezdiffra and plans for European expansion. The company's robust financial position and strategic focus position it well for future growth in addressing this critical unmet medical need.