Madrigal Pharmaceuticals Announces Q1 2024 Financials and Corporate Updates

Madrigal Pharmaceuticals, Inc., a biopharmaceutical company headquartered in Conshohocken, Pennsylvania, has reported significant progress in the first quarter of 2024. The company's key focus is on developing novel therapeutics for nonalcoholic steatohepatitis (NASH), an advanced form of nonalcoholic fatty liver disease (NAFLD) that leads to liver-related complications.

On March 14, 2024, Madrigal achieved a milestone by receiving U.S. FDA approval for Rezdiffra™ (resmetirom), the first and only medication approved for the treatment of noncirrhotic NASH with moderate to advanced liver fibrosis. This approval marks a significant advancement in addressing a critical unmet medical need for patients. NASH is a serious liver condition affecting an estimated 1.5 million individuals in the U.S., with approximately 525,000 of those having moderate to advanced liver fibrosis. Madrigal's efforts are now concentrated on approximately 315,000 diagnosed patients who are under the care of specialist physicians.

Rezdiffra's approval was based on the results of the Phase 3 MAESTRO-NASH trial, which demonstrated efficacy in stopping or improving fibrosis in over 80% of patients. The trial's findings, published in The New England Journal of Medicine in February 2024, support Rezdiffra's role as a foundational therapy for NASH. The drug is a once-daily, oral, liver-directed, THR-β agonist, designed to address key underlying causes of NASH without the need for liver biopsy for diagnosis, containing no contraindications, boxed warnings, or monitoring requirements beyond standard care.

Madrigal has built a robust team across sales, medical affairs, market access, and patient support to ensure a successful U.S. launch of Rezdiffra. The company began shipping the medication in April 2024, and the sales team is actively engaging healthcare providers to educate them about NASH and Rezdiffra. The market access team is working with national and regional payers to secure coverage and increase patient access to the medication.

On the international front, Madrigal announced on March 5, 2024, that its Marketing Authorization Application (MAA) for resmetirom had been validated and was under evaluation by the European Medicines Agency (EMA). This progression signals a potential expansion of Rezdiffra's availability beyond the U.S., making it the first therapy for NASH/MASH patients with liver fibrosis to potentially receive approval in Europe.

In terms of financial updates, Madrigal raised $690 million in gross proceeds through a public offering and full over-allotment exercise. This influx of funds strengthens the company's balance sheet, with cash, cash equivalents, and marketable securities totaling $1.1 billion as of March 31, 2024, compared to $634.1 million at the end of 2023.

Operational expenses for the first quarter of 2024 amounted to $152.0 million, compared to $78.3 million in the same period the previous year. This increase is primarily due to commercial preparation activities for the launch of Rezdiffra. Research and development expenses also saw a rise to $71.2 million, reflecting increased manufacturing, headcount, and stock compensation expenses. Selling, general, and administrative expenses surged to $80.8 million, driven by commercial headcount expansion and launch preparations.

Madrigal's leadership team welcomed Mardi C. Dier as Chief Financial Officer in February 2024, bringing over 20 years of executive financial leadership experience in biotechnology companies.

In addition to corporate and financial updates, Madrigal presented five health economic abstracts at the NASH-TAG conference in January 2024, highlighting the clinical burden of uncontrolled NASH and identifying opportunities for improving patient care.

Overall, Madrigal Pharmaceuticals is poised for a transformative year with the launch of Rezdiffra, addressing a significant unmet need in the treatment of NASH and building a foundation for long-term leadership in this therapeutic area.