Mirum(MIRM) - 2025 Q2 - Quarterly Results

Q2 2025 Highlights and Business Update Mirum Pharmaceuticals reported strong Q2 2025 results with $128 million total revenue, raising full-year guidance to $490-$510 million, and advancing its late-stage pipeline Q2 2025 Key Metrics | Metric | Value | | :--- | :--- | | Total Revenue | $128 million | | 2025 Revenue Guidance | Increased to $490 - $510 million | - Commercial strength was noted in the International business and the U.S. Progressive Familial Intrahepatic Cholestasis (PFIC) launch[2] - The company anticipates three significant late-stage clinical milestones in 2026[2] - The VISTAS study of volixibat in Primary Sclerosing Cholangitis (PSC) is expected to complete enrollment this quarter, with topline data planned for Q2 2026[2][4] Commercial Performance Global net product sales reached $127.8 million in Q2 2025, driven by strong LIVMARLI growth and the U.S. launch of a single oral tablet dose Q2 2025 Net Product Sales (YoY Growth) | Product Line | Q2 2025 Sales | YoY Growth | | :--- | :--- | :--- | | LIVMARLI | $88.2 million | 87% | | Bile Acid Medicines | $39.6 million | 30% | | Total Global Net Product Sales | $127.8 million | N/A | - A single oral tablet dose of LIVMARLI was launched in the U.S. in June 2025[4] Pipeline Development Mirum's late-stage pipeline is advancing with key clinical milestones expected in 2026, including topline data for volixibat in PSC and a new Phase 2 study for MRM-3379 - Key upcoming clinical milestones include Volixibat (VISTAS study in PSC) with topline data expected in Q2 2026, Volixibat (VANTAGE study in PBC) with enrollment completion expected in 2026, and LIVMARLI (EXPAND Phase 3 study) with enrollment completion expected in 2026[4] - A Phase 2 study for MRM-3379, a PDE4D inhibitor for Fragile X Syndrome (FXS), is planned to initiate in Q4 2025[4][22] Financial Results Mirum reported Q2 2025 total revenue of $127.8 million, significantly narrowing its net loss to $5.9 million, and maintaining a strong cash position of $321.7 million - As of June 30, 2025, Mirum had $321.7 million in unrestricted cash, cash equivalents, and investments, an increase from $292.8 million as of December 31, 2024[4] Condensed Consolidated Statement of Operations Q2 2025 total revenue grew 64% to $127.8 million, significantly reducing the net loss to $5.9 million despite increased operating expenses Q2 2025 Statement of Operations (in thousands, except per share data) | Metric | Q2 2025 | Q2 2024 | | :--- | :--- | :--- | | Total revenue | $127,785 | $77,875 | | Total operating expenses | $132,774 | $102,107 | | Loss from operations | $(4,989) | $(24,232) | | Net loss | $(5,861) | $(24,638) | | Net loss per share | $(0.12) | $(0.52) | - Total operating expenses for Q2 2025 included $24.5 million of non-cash expenses, compared to $17.7 million in Q2 2024[4] Condensed Consolidated Balance Sheet As of June 30, 2025, total assets increased to $725.8 million, with total liabilities at $470.7 million and stockholders' equity at $255.2 million Balance Sheet Highlights (in thousands) | Account | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash, cash equivalents & investments | $321,664 | $292,841 | | Total assets | $725,825 | $670,754 | | Total liabilities | $470,667 | $445,114 | | Total stockholders' equity | $255,158 | $225,640 | Product Portfolio Overview Mirum's commercial portfolio includes LIVMARLI®, CHOLBAM®, and CTEXLI™, with ongoing label expansion for LIVMARLI and pipeline advancement for volixibat in adult cholestatic diseases - LIVMARLI® (maralixibat) is approved for cholestatic pruritus in patients with Alagille syndrome (ALGS) and progressive familial intrahepatic cholestasis (PFIC)[6] - Volixibat is an investigational IBAT inhibitor being evaluated for primary sclerosing cholangitis (PSC) and primary biliary cholangitis (PBC), and has received breakthrough therapy designation for PBC[12] - CHOLBAM® (cholic acid) is approved for bile acid synthesis disorders and adjunctive treatment of peroxisomal disorders[13] - CTEXLI™ (chenodiol) is approved for the treatment of adults with cerebrotendinous xanthomatosis (CTX)[17]