Madrigal Pharmaceuticals (MDGL) Q2 2024 earnings summary

Executive summary

• Rezdiffra launched in April 2024 after FDA accelerated approval for noncirrhotic NASH with moderate to advanced fibrosis, achieving over 2,000 patients on therapy and $14.6 million in Q2 2024 net sales, driven by strong physician awareness and demand.

• More than 50% of U.S. commercial lives are covered for Rezdiffra, with Medicaid coverage in all states and less than 5% of plans requiring biopsy; Medicare coverage is expected by January 2025.

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

• The company plans direct commercialization in Europe, with EMA approval anticipated mid-2025, leveraging strong clinical trial presence and favorable guidelines.

Financial highlights

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

• 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 by year-end 2024 and full Medicare coverage by January 2025.

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

• Gross-to-net expected to be volatile in early quarters due to co-pay assistance dynamics.

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

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