Madrigal Pharmaceuticals (MDGL) Q3 2024 earnings summary

Executive summary

• Rezdiffra (resmetirom) became the first and only FDA-approved therapy for NASH in March 2024 and was commercially launched in the U.S. in April 2024, achieving foundational status with robust uptake and >80% commercial coverage ahead of schedule.

• Over 6,800 patients were on Rezdiffra at quarter-end, with rapid expansion in prescriber base and >95% of payers accepting noninvasive tests.

• Completed enrollment in the MAESTRO-NASH OUTCOMES trial for compensated NASH/MASH cirrhosis, advancing leadership in NASH treatment.

• Preparing for a potential European launch in H2 2025, pending EMA approval, with direct commercialization plans if approved.

• Cash, cash equivalents, and marketable securities totaled $1.0 billion as of September 30, 2024.

Financial highlights

• Net sales for Q3 2024 were $62.2 million, marking the first period of product revenue for Rezdiffra.

• Operating expenses rose to $178.5 million from $98.5 million year-over-year, driven by commercial launch activities and increased headcount.

• 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.

Outlook and guidance

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

• Positive results from the MAESTRO-NASH OUTCOMES trial could lead to full approval and expanded indications.

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

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

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