Madrigal Pharmaceuticals (MDGL) H.C. Wainwright 8th Annual MASH Virtual Conference summary

Strategic vision and leadership

• Leadership transition has driven high expectations and rapid progress, with a focus on addressing unmet needs in NASH/MASH and building a strong company foundation.

• Achieved key milestones including regulatory acceptance, priority review, and immediate post-approval launch readiness.

• Laying groundwork for future leadership, aiming for global brand status and a robust pipeline within three to five years.

• Hired a leading clinical expert to strengthen internal expertise and support portfolio expansion.

• Committed to developing a portfolio beyond a single product to maintain long-term leadership.

Product launch and market uptake

• First-in-disease launch for NASH, requiring significant system preparation and physician training.

• Q2 sales reached $14.6 million, with over 2,000 patients on therapy and more than 50% of commercial lives covered.

• Majority of patients are paid, with minimal free drug use; early feedback aligns with clinical trial tolerability.

• Organic growth driven by regular patient visits, not by a pre-identified bolus of patients.

• About 20% of targeted physicians have prescribed, with gastroenterologists expected to drive most prescriptions.

Payer access and reimbursement

• Coverage surpassed 50% in Q2, with a goal of 80% by year-end; recent PBM additions have increased coverage.

• Over 95% of payers accept non-invasive tests (NITs) for diagnosis, minimizing biopsy requirements.

• Medicaid access began in July; Medicare expected to expand in the new year, with current access via exceptions.

• Prior authorization is standard, with reauthorization typically required annually.

• No significant step edits requiring GLP-1 use before access to therapy have been observed.