Release Date: May 07, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Madrigal Pharmaceuticals Inc (MDGL, Financial) achieved US FDA approval for its NASH treatment, marking a significant milestone in its commercial strategy.
- The company successfully launched its patient support program and began shipping its NASH treatment product to specialty pharmacy networks, ensuring availability for patients.
- Madrigal Pharmaceuticals Inc (MDGL) raised $690 million in gross proceeds from a public offering, enhancing its financial stability and resourcing for the product launch.
- The company's NASH treatment has been added to medical compendia and electronic medical records systems, facilitating easier prescription processes for healthcare providers.
- Madrigal Pharmaceuticals Inc (MDGL) reported strong interest and positive feedback from healthcare providers, with over 80% of top physician targets already reached by the sales team.
Negative Points
- The company recorded no revenue from its NASH treatment in the first quarter due to timing of shipments, indicating a slow start in terms of sales.
- Significant increases in R&D and SG&A expenses were reported, reflecting the high costs associated with the launch and ongoing development efforts.
- Challenges with payer coverage and the need for extensive 'wiring the system' efforts could slow down the pace of prescription fills and patient access in the initial months.
- The VA's requirement for liver biopsy as part of the treatment protocol contradicts current guidelines and could limit patient access under this plan.
- Madrigal Pharmaceuticals Inc (MDGL) faces potential competition from upcoming treatments like semaglutide, which could impact market share if they demonstrate similar efficacy.
Q & A Highlights
Q: Could you highlight whether there is heterogeneity in the payers' discussions, or does it seem that the majority of the payers are aligned in terms of their requirements for just simple blood-based tests?
A: (Bill Sibold - CEO) It's still early in our discussions with payers, but there is a tremendous clinical interest in our NASH treatment. We're focusing on the 315,000 diagnosed patients under specialist care, which resonates well with payers. We've scheduled P&T committee meetings and are on track to reach our target of 80% commercial coverage by year-end. So far, the discussions have been positive without significant surprises.
Q: Can you provide any color on what proportion of your top physician targets have written a prescription? Also, could you discuss the physician feedback on the medical exception process?
A: (Bill Sibold - CEO) Most physicians are currently going through a medical exception process, which is expected at this stage. Our target physician group is about 6,000, and we've seen good engagement with them. It's still early, but the leading indicators are supportive of a successful launch.
Q: Regarding the VA's requirement for liver biopsy, can you discuss your strategy to address this and the percentage of the 315,000 patients that are part of the VA?
A: (Bill Sibold - CEO) The VA's decision was disappointing and counter to current guidelines that support the use of non-invasive tests. We are working to have this corrected by 2025. The number of patients covered by the VA is a very small percentage, so the impact is limited.
Q: Could you discuss your preparations for launching in the EU and how this might impact your operating expenses?
A: (Bill Sibold - CEO) We're excited about the opportunity to expand geographically. We're currently strategizing for the EU market, aiming to establish Madrigal as a leader in NASH globally. The investment for EU expansion is expected to have a payback within one to two years.
Q: Are there any early insights on the noninvasive algorithm for pre-authorization in insurance discussions? How might this be affected by upcoming AASLD guidelines?
A: (Bill Sibold - CEO) It's early, but payers are evaluating a range of non-invasive tests (NITs), typically a combination of blood and imaging. Updated guidelines that include our treatment are anticipated, which should help clarify the use of NITs and potentially streamline the pre-authorization process.
Q: Do you expect the VA's decision on liver biopsy requirements to influence other commercial or government plans' initial coverage policy decisions?
A: (Bill Sibold - CEO) We do not anticipate a read-through from the VA's decision to other payers. Each payer makes independent decisions, and there is a strong appreciation for the clinical data and our strategic approach among the larger plans.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
