Madrigal Pharmaceuticals (MDGL) Q2 2024 earnings summary

Executive summary

• Rezdiffra launched in the U.S. in April 2024, recording over 2,000 patients on therapy and $14.6 million in Q2 2024 net sales, with strong initial demand and high physician uptake, especially among hepatologists.

• Updated EASL and U.S. expert guidelines recommend Rezdiffra as first-line therapy for F2/F3 NASH/MASH, reinforcing its clinical value.

• Over 50% of U.S. commercial lives are covered, with less than 5% requiring biopsy for diagnosis and increasing acceptance of non-invasive tests.

• Direct commercialization in Europe is planned, with EMA approval expected mid-2025 and infrastructure build underway.

• The company is focused on “wiring the system” to streamline prescription flow and support future growth, a process expected to take about 12 months.

Financial highlights

• Q2 2024 net product sales were $14.6 million, driven by patient demand, with no prior period sales.

• Operating expenses rose to $177.2 million from $86.5 million year-over-year, mainly due to higher SG&A and R&D costs related to the launch.

• Net loss for Q2 2024 was $152.0 million, compared to $85.8 million in Q2 2023.

• Cash, cash equivalents, and marketable securities totaled $1.1 billion as of June 30, 2024, up from $634.1 million at year-end 2023, mainly due to a public offering.

• Interest income increased to $14.2 million from $3.6 million year-over-year.

Outlook and guidance

• Targeting 80% U.S. commercial coverage for Rezdiffra by year-end 2024, with Medicare coverage expected in January 2025.

• EMA decision on European approval expected mid-2025, with direct commercialization planned upon approval.

• MAESTRO-NASH Outcomes trial could expand indication to compensated cirrhosis if successful.

• Management expects cost of sales and SG&A expenses to increase as commercialization continues.

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