Core Viewpoint - Mirum Pharmaceuticals is positioned for significant growth, with its share price having more than doubled in the past year and expectations for further increases in 2026 due to key developments in its pipeline and financial performance [1]. Financial Performance - Mirum achieved positive cash flow from operations in 2025, marking a significant milestone for the company [2]. - Net product sales for Livmarli increased by 69% year over year in 2025, reaching $359 million, while sales for Cholbam and Ctexli rose by 31% to $161 million. The company anticipates overall revenue guidance of $630 million to $650 million for the current year [5]. Regulatory Approvals - The company received two FDA approvals in the previous year: Ctexli for treating cerebrotendinous xanthomatosis and a tablet formulation of Livmarli for cholestatic pruritus in patients with Alagille syndrome and Progressive Familial Intrahepatic Cholestasis [3]. Pipeline Developments - On January 26, 2026, Mirum completed the acquisition of Bluejay Therapeutics, adding brelovitug to its pipeline, which targets chronic hepatitis delta virus, a rare liver disease with no current approved treatment in the U.S. [4]. - The company is expecting results from a Phase 2B clinical study of volixibat for primary sclerosing cholangitis in the second quarter of 2026, with plans to file for accelerated approval in the second half of the year [6]. - Results from a Phase 3 study of brelovitug for HDV treatment are anticipated in the latter half of 2026, with potential filing for approval in early 2027 if results are positive [8]. - The timing of the Phase 3 study of Livmarli for pruritus in rare cholestatic conditions has been accelerated, with enrollment expected to complete in the first half of 2026 and topline data to be reported by year-end [9].

Core Insights - Mirum Pharmaceuticals is a mid-cap biotech stock that has seen significant gains, with a nearly 70% increase in 2025, and is expected to perform even better in 2026 [2][3] Company Performance - The current market capitalization of Mirum Pharmaceuticals is $4 billion, with a current stock price of $69.88 and a gross margin of 79.85% [3] - Livmarli, one of Mirum's three approved products, is the primary growth driver, with sales increasing by 56% year-over-year in Q3 2025 to $92.2 million, accounting for approximately 69% of total sales [3][4] - Combined sales for Mirum's other two bile acid medicines, Cholbam and Ctexli, rose by 31% year-over-year in Q3 to $40.8 million [6] Product Approvals and Pipeline - Livmarli was first approved by the FDA in September 2021 for treating cholestatic pruritus in patients with Alagille syndrome, a rare genetic disorder [4] - In 2024, Mirum received two additional FDA approvals for Livmarli for treating Progressive Familial Intrahepatic Cholestasis (PFIC) in patients aged five years and older, and for a tablet version of Livmarli [5] - The company has two promising pipeline candidates, voloxibat and MRM-3379, which could also contribute significantly to future revenue [8][10] Future Outlook - The introduction of a tablet formulation of Livmarli is expected to enhance sales, with early indications of strong uptake [7] - Mirum anticipates that Livmarli could generate annual sales exceeding $1 billion [8] - Positive topline data from ongoing Phase 2 studies for voloxibat and MRM-3379 could serve as catalysts for further stock performance [9][10]

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]