Madrigal Pharmaceuticals (MDGL) Q3 2024 earnings summary

Executive summary

• Rezdiffra became the first FDA-approved therapy for NASH in March 2024 and launched in the U.S. in April, achieving over 6,800 patients on therapy and >80% commercial coverage ahead of schedule.

• Net sales reached $62.2 million in Q3 2024, reflecting robust demand and rapid patient uptake, with no comparable sales in the prior year.

• Completed enrollment in the MAESTRO-NASH OUTCOMES trial for cirrhotic NASH, positioning Rezdiffra for potential first-to-market status in compensated NASH cirrhosis.

• European launch preparations are underway, with EMA decision expected mid-2025 and direct commercialization planned if approved.

• Cash, cash equivalents, and marketable securities totaled $1.0 billion as of September 30, 2024, supporting ongoing launches and clinical development.

Financial highlights

• Net sales for Q3 2024 were $62.2 million, with total revenues for the nine months ended September 30, 2024, at $76.8 million.

• Operating expenses rose to $178.5 million in Q3 2024 from $98.5 million year-over-year, driven by commercial launch activities.

• SG&A expenses increased to $107.6 million from $27.6 million year-over-year, reflecting launch investments.

• R&D expenses were $68.7 million in Q3 2024, down from $71.0 million in Q3 2023.

• Net loss for Q3 2024 was $107.0 million, compared to $98.7 million in Q3 2023; net loss for the nine months ended September 30, 2024, was $406.5 million.

Outlook and guidance

• EMA decision on Rezdiffra expected mid-2025, with plans for direct commercialization in Europe upon approval.

• Management anticipates continued strong growth into Q4 2024 and 2025, supported by robust demand and expanding prescriber base.

• Gross-to-net is expected to be volatile in early launch quarters, with a step up anticipated in Q1 2025 due to insurance re-authorizations and IRA impacts.

• Persistency rates are expected to be strong, with early indicators in line with other well-tolerated oral medicines.

• Current cash resources are sufficient to fund operations past one year from the financial statement issuance.