Core Insights - Mirum Pharmaceuticals reported earnings of 5 cents per share for Q3 2025, surpassing the Zacks Consensus Estimate of a loss of 10 cents, and improved from a loss of 30 cents per share in the same quarter last year [1][8] - Revenues for Q3 reached $133 million, a year-over-year increase of 47.1%, exceeding the Zacks Consensus Estimate of $132 million, driven by strong sales of Livmarli and bile acid products [2][8] Financial Performance - Livmarli's net product sales were $92 million in Q3, reflecting a 56% increase year over year, with U.S. sales at $64 million and international sales at $28 million [6][8] - Net product sales of bile acid products, including Cholbam and Ctexli, totaled $40.8 million in Q3, marking a 31% year-over-year increase [9] - Research and development expenses rose by 35.6% year over year to $43 million, while selling, general, and administrative expenses increased by 22.6% to $61.9 million [9] Guidance and Outlook - The company tightened its 2025 revenue guidance to a range of $500-$510 million, up from the previous range of $490-$510 million, with the Zacks Consensus Estimate currently at $508.9 million [11] Product Developments - Livmarli is approved for treating cholestatic pruritus in patients with Alagille syndrome and certain patients with progressive familial intrahepatic cholestasis [3] - A new tablet formulation of Livmarli was launched in the U.S. in June 2025, aimed at providing convenience for older patients [4] - Mirum acquired Travere Therapeutics' bile acid products in August 2023, enhancing its portfolio with Cholbam and Ctexli [4] Pipeline Updates - Mirum is conducting a phase III EXPAND study for Livmarli in rare cholestatic conditions, with enrollment expected to complete in 2026 [12] - The lead pipeline candidate, volixibat, is under evaluation in two phase IIb studies for primary biliary cholangitis and primary sclerosing cholangitis [12][13] - A phase II study on the newly in-licensed PDE4D inhibitor, MRM-3379, for Fragile X syndrome has been initiated [13] Market Performance - Mirum's shares have increased by 71.7% year to date, significantly outperforming the industry average rise of 10.9% [5]

Core Insights - Mirum Pharmaceuticals reported a narrower loss of 30 cents per share in Q1 2025, compared to a loss of 54 cents per share in the same quarter last year, and better than the Zacks Consensus Estimate of a loss of 39 cents [1][2] - The company's revenues for Q1 2025 reached $111.6 million, reflecting a year-over-year increase of nearly 62%, surpassing the Zacks Consensus Estimate of $98 million [2][3] Financial Performance - Livmarli's net product sales were $73.2 million in Q1 2025, marking a 71% increase year over year, with U.S. sales at $49.5 million and ex-U.S. sales at $23.7 million [6] - Net product sales from bile acid products, including Cholbam and Ctexli, totaled $38.4 million in Q1 2025, up 47% year over year [7] - Research and development expenses rose by 42.8% year over year to $46 million, while selling, general, and administrative expenses increased by 26.5% to $57.7 million [7][8] Guidance and Future Outlook - Mirum raised its full-year revenue guidance for 2025 to a range of $435-$450 million, up from the previous estimate of $420-$435 million, due to strong demand for its commercial products [9] - The company is evaluating Livmarli in a phase III study for treating pruritus in rare cholestatic conditions, with enrollment expected to complete in 2026 [10] Recent Developments - The FDA approved a new tablet formulation of Livmarli for treating cholestatic pruritus in patients with Alagille syndrome and progressive familial intrahepatic cholestasis [10] - Ctexli tablets received FDA approval for treating adults with cerebrotendinous xanthomatosis, becoming the first approved treatment for this condition [11] - Mirum's lead pipeline candidate, volixibat, is in two phase IIb studies for primary biliary cholangitis and primary sclerosing cholangitis, with enrollment expected to complete in 2026 [11][12]