Release Date: October 31, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Madrigal Pharmaceuticals Inc (MDGL, Financial) reported strong net sales of $62 million for the third quarter, driven by high demand for Rezdiffra.
- The company achieved its goal of securing coverage for 80% of commercial lives a full quarter ahead of schedule.
- Rezdiffra is recognized as a foundational therapy for NASH, with healthcare providers showing high confidence in its efficacy and tolerability.
- The company completed enrollment in the MAESTRO-NASH OUTCOMES trial, positioning Rezdiffra as a potential first therapy for patients with compensated NASH cirrhosis.
- Madrigal Pharmaceuticals Inc (MDGL) has a strong cash position of $1 billion, supporting ongoing and future launches, including a planned launch in Europe in 2025.
Negative Points
- SG&A expenses increased significantly to $107.6 million from $27.6 million in the previous year, primarily due to the expansion of commercial operations.
- Gross to net adjustments are expected to be choppy, particularly in early quarters, with potential impacts from insurance reops and the IRA in Q1 2025.
- There is uncertainty regarding the impact of potential competition from GLP-1 class drugs, such as semaglutide, on Rezdiffra's market position.
- The company is still in the early stages of the Rezdiffra launch, with only 2% of the target 315,000 NASH patients currently on treatment.
- Persistence and refill rates for Rezdiffra are still being evaluated, with more data needed to fully understand long-term patient adherence.
Q & A Highlights
Q: Given the strong performance, could you talk about your forecast for the fourth quarter and growth into 2025?
A: Bill Sibold, CEO: We're thrilled with the launch's progress, with great coverage and patient additions. We're benchmarking against successful specialty launches and tracking well. For 2025, while we want to see how 2024 plays out, we anticipate increased expectations due to robust growth.
Q: What are you seeing in terms of the cadence of new patient starts? Are they accelerating?
A: Bill Sibold, CEO: We are steadily adding patients and prescribers. We're not at steady state yet, as we continue to wire the system. We expect this pace to continue as we add new prescribers and patients.
Q: Which trial are you more confident in hitting outcomes, MAESTRO-NASH or the F4 patient trial?
A: Bill Sibold, CEO: We're confident in both trials. For the cirrhosis trial, based on results from the NAFLD-1 trial, we believe Rezdiffra may work well in this population. We expect significant learnings for the community from the cirrhosis trial.
Q: Can you talk about the amount of free drug being utilized and your satisfaction with the commercial co-pay program?
A: Bill Sibold, CEO: Very little free drug was utilized this quarter. We have a strong co-pay program, and while utilization was low, we expect it to increase over time. We aim for equitable access and are committed to helping patients get the product.
Q: How are payers handling patients already on GLP therapies and Rezdiffra?
A: Bill Sibold, CEO: About 25% of Rezdiffra patients are also on a GLP-1 for comorbidities. We expect GLP-1s to continue being used for comorbidities, and physicians are reaching for Rezdiffra for NASH treatment regardless of GLP-1 exposure.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
