CONSHOHOCKEN, PA — Madrigal Pharmaceuticals, Inc. (NASDAQ: MDGL) announced its financial results for the second quarter ending June 30, 2024. The company reported net sales of $14.6 million, driven by the U.S. launch of Rezdiffra™ (resmetirom).
Rezdiffra, a once-daily, oral, liver-directed THR-β agonist, has coverage for more than 50 percent of commercial lives in the U.S., with less than 5 percent requiring a biopsy for diagnosis. The company aims to commercialize Rezdiffra in Europe following a regulatory decision in mid-2025.
“We’re off to a strong start with our U.S. launch of Rezdiffra and are encouraged by the high enthusiasm and early demand from physicians and patients, as well as the favorable coverage from payers,” said Bill Sibold, CEO of Madrigal. “Given the strong start in the U.S., we aim to extend Madrigal’s global leadership in NASH by directly commercializing Rezdiffra in Europe next year upon regulatory approval.”
Second Quarter and Recent Corporate Updates:
- Rezdiffra U.S. Launch: Since April 9, 2024, Rezdiffra has been available in the U.S., targeting NASH, a leading cause of liver transplants in women.
- European Expansion: Madrigal plans to directly commercialize resmetirom in Europe, pending EMA approval, expected mid-2025.
- Expert Guidelines: Recent guidelines recommend Rezdiffra as the first-line therapy for patients with F2/F3 NASH/MASH.
- EASL Congress Presentations: Data showed 91% efficacy in halting or improving liver stiffness over three years.
Financial Highlights:
- Net Sales: $14.6 million in Q2 2024.
- Operating Expenses: $177.2 million, up from $86.5 million in the prior year.
- R&D Expense: $71.1 million, up from $68.6 million.
- SG&A Expense: $105.4 million, up from $17.8 million.
- Interest Income: $14.2 million, up from $3.6 million.
- Interest Expense: $3.7 million, up from $2.9 million.
- Cash and Equivalents: $1.1 billion, up from $634.1 million at the end of 2023.
Buy, Sell, or Hold?
Madrigal Pharmaceuticals shows solid early performance with Rezdiffra and strong financial health. However, significant operating expenses and the need for European regulatory approval add risk. Given these factors, Madrigal Pharmaceuticals is a Hold. Investors should monitor the U.S. launch progress and upcoming European decisions.
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