• Net Sales (Q4 2024): $103.3 million, reflecting 66% quarter-over-quarter growth.
• Net Sales (Full Year 2024): $180.1 million, achieved in nine months of commercialization.
• Patients on Therapy (End of Q4 2024): Over 11,800 patients actively on Rezdiffra.
• R&D Expenses (Q4 2024): $25.6 million.
• R&D Expenses (Full Year 2024): $236.7 million, decreased by $35.6 million from the prior year.
• SG&A Expenses (Q4 2024): $141.2 million.
• SG&A Expenses (Full Year 2024): $435.1 million, reflecting the scale-up of US commercial operations.
• Cash Position (End of 2024): $931.3 million in cash, cash equivalents, restricted cash, and marketable securities.

• Warning! GuruFocus has detected 3 Warning Signs with MDGL.

Release Date: February 26, 2025

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

• Madrigal Pharmaceuticals Inc (NASDAQ:MDGL) reported strong financial results with $103 million in net sales for Q4 2024, reflecting a 66% quarter-over-quarter growth.
• The company achieved a significant milestone with the approval of Rezdiffra, the first-ever treatment for MASH, and has been included in updated guidelines by top liver societies in Europe and the US.
• Rezdiffra's launch trajectory is tracking in line with some of the most successful specialty medicine launches in the past decade, indicating strong market demand.
• The company has achieved greater than 80% commercial coverage for Rezdiffra, one quarter ahead of schedule, and continues to expand its prescriber base.
• New two-year data from the MAESTRO-NASH trial shows promising results for Rezdiffra in patients with compensated MASH cirrhosis, supporting its potential benefit in this high-risk population.

Negative Points

• Despite the strong launch, Rezdiffra has penetrated less than 4% of the 315,000 diagnosed patients with F2, F3 MASH, indicating a long road ahead for market expansion.
• The company anticipates an increase in the gross to net discount in 2025, which could impact net sales growth.
• R&D expenses are expected to increase in 2025 compared to 2024, potentially affecting profitability.
• SG&A expenses saw a significant year-over-year increase due to the rapid scale-up of US commercial operations, and further increases are expected in 2025.
• The European launch of Rezdiffra may face challenges due to potential pricing pressures and the need for country-by-country regulatory approvals.

Q & A Highlights

Q: Can you comment on the progress of the Rezdiffra launch and any notable trends in the first two months of 2025? A: Bill Sibold, CEO: The momentum from 2024 has carried into 2025, with steady additions of patients and prescribers. We are managing the typical Q1 dynamics well, and there is no prescriber yet maxed out on patients. We continue to add new prescribers, reaching 60% penetration into our target group.

Q: Could you elaborate on the clinical significance of the 6.7 kilopascal reduction in liver stiffness for F4 cirrhotic patients? A: Michael Charlton, SVP Clinical Development: A 6.7 kilopascal reduction, starting from a baseline of 25 kilopascals, is highly predictive of decreased risk of clinical outcomes. This reduction suggests a significant move into a lower risk category for liver-related events.

Q: Will Madrigal provide guidance for 2025, and how do you view consensus estimates? A: Mardi Dier, CFO: We are not providing specific guidance at this time due to the early stage of the launch. However, we are pleased with the momentum going into 2025 and expect consensus for Q1 and the full year to narrow and increase slightly based on current trends.

Q: How do you view the potential impact of GLP-1 therapies on Rezdiffra's market position? A: Bill Sibold, CEO: We believe GLP-1 therapies will expand the market, benefiting Rezdiffra as the leader. Our product's profile, ease of use, and rapid efficacy make it the preferred choice for patients with severe liver disease. We expect to maintain our leadership position despite new entrants.

Q: What are the challenges and strategies for launching Rezdiffra in Europe? A: Bill Sibold, CEO: We will approach Europe on a country-by-country basis, aiming for positive contribution within two to three years. We believe in the value of Rezdiffra and will engage in discussions with each country to support favorable pricing. Our strategy is to pursue markets where the value of Rezdiffra is recognized.

For the complete transcript of the earnings call, please refer to the full earnings call transcript.