Business
Mirum Pharmaceuticals Reports First Quarter 2025 Financial Results and Provides Business Update
- First quarter 2025 total revenue of $111.6 million; 2025 guidance increased to $435 to $450 million - VISTAS study in PSC expected to complete enrollment
About this update from Mirum Pharmaceuticals, Inc.
[{"type":"text","content":"\n- First quarter 2025 total revenue of $111.6 million; 2025 guidance increased to $435 to $450 million\n\n- VISTAS study in PSC expected to complete enrollment in third quarter of 2025; topline data expected in second quarter of 2026\n\n- LIVMARLI oral tablet formulation FDA approved\n\n- Conference call to provide business updates today, May 7 at 1:30 p.m. PT/4:30 p.m. ET\n\n FOSTER CITY, Calif.--(BUSINESS WIRE)--\nMirum Pharmaceuticals, Inc. (Nasdaq: MIRM) today reported financial results for the first quarter 2025 and provided a business update.\n\n“It’s been a strong start to the year with commercial growth and multiple milestones achieved across our pipeline,” said Chris Peetz, chief executive officer of Mirum. “We’re pleased with the FDA’s approval of LIMARLI’s tablet formulation, which provides more options for the ALGS and PFIC community in the U.S. in the form of a convenient single tablet dose. Our VISTAS study of volixibat in PSC is enrolling well and we expect to complete enrollment in the third quarter of this year. We’re excited to continue our strong execution across our commercial medicines and pipeline throughout the year.”\n\nCommercial: Raising full year revenue guidance to $435 to $450 million\n\n\nFirst quarter 2025 global net product sales of $111.6 million.\n\n\nFirst quarter 2025 LIVMARLI net product sales were $73.2 million representing 71% growth over first quarter 2024 net product sales.\n\n\nBile Acid Medicines net product sales were $38.4 million representing 47% growth over first quarter 2024 net product sales.\n\n\nLIVMARLI oral tablet formulation approved.\n\n\nLIVMARLI approved in Japan for ALGS and PFIC.\n\n\nCTEXLI (chenodiol) approved in the US for cerebrotendinous xanthomatosis.\n\n\nRegulatory and Pipeline: Clinical milestones on track\n\n\nVolixibat VISTAS study in primary sclerosing cholangitis (PSC) expected to complete enrollment in third quarter of 2025; topline data expected in the second quarter of 2026.\n\n\nOral presentation of 28-week interim data from volixibat in PBC (VANTAGE study) at EASL on Friday May 9th at 9:30am CEST.\n\n\nVolixibat VANTAGE study in primary biliary cholangitis (PBC) expected to complete enrollment in 2026.\n\n\nLIVMARLI EXPAND Phase 3 study for pruritus in rare cholestatic conditions expected to complete enrollment in 2026.\n\n\nExpect to initiate Phase 2 ...