Mirum Sets High Bar with Strong 2025 Ahead of Earnings Call

FOSTER CITY, CA – February 18, 2026 – Mirum Pharmaceuticals (NASDAQ: MIRM) is poised to detail a year of significant financial and clinical achievement when it hosts its fourth quarter and year-end 2025 earnings call on February 25. While the official report is a week away, the rare disease specialist has already signaled a landmark year, releasing preliminary unaudited results in January that surpassed both its own guidance and analyst expectations, setting a confident tone for its future outlook.

The upcoming call is now anticipated to be less about revealing past performance and more about articulating the strategic execution plan for 2026, a year already packed with expected clinical catalysts and ambitious growth targets. For investors and the rare disease community, the focus will be on how Mirum intends to build upon its momentum, expand its commercial reach, and advance a pipeline that addresses some of the most challenging overlooked conditions.

A Year of Record Growth and Financial Strength

Mirum's 2025 performance represents a significant inflection point, transitioning the company into a new phase of financial maturity. The firm announced preliminary net product sales of approximately $520 million for the year, comfortably exceeding its revised guidance of $500-$510 million and the Wall Street consensus of $507 million. This achievement marks a substantial leap from the $336.4 million in total sales recorded in 2024.

The growth was driven by robust performance across its commercial portfolio. LIVMARLI® (maralixibat), for Alagille syndrome (ALGS) and progressive familial intrahepatic cholestasis (PFIC), was the primary revenue engine, generating an estimated $359 million in net sales—a remarkable 69% increase from the prior year. The company's bile acid medicines, CHOLBAM® (cholic acid) and CTEXLI® (chenodiol), also showed strong, mature growth, contributing approximately $161 million, up 31% from 2024.

This commercial success translated directly to the bottom line. After reporting its first-ever quarter of positive net income in the third quarter of 2025, Mirum achieved positive cash flow from operations for the full year. The company ended 2025 with a strong cash position of approximately $392 million, providing substantial capital to fuel its strategic initiatives. This financial strength has bolstered market confidence, with most analysts maintaining a "Strong Buy" rating and seeing continued upside, especially as the company guides for 2026 global net product sales between $630 million and $650 million.

Strategic Expansion Through Pipeline and Acquisition

While commercial execution has been stellar, Mirum's strategic focus on expanding its therapeutic pipeline has been equally aggressive. The most significant recent move was the acquisition of Bluejay Therapeutics, completed in January 2026. This strategic transaction brought brelovitug, a late-stage monoclonal antibody for treating chronic hepatitis delta virus (HDV), into Mirum's fold. The addition is a calculated expansion, positioning the company to enter a new disease area with a high unmet need, with pivotal Phase 3 data for brelovitug anticipated in the second half of 2026.

Progress in its existing late-stage pipeline is also accelerating. Topline data from the VISTAS study for volixibat in primary sclerosing cholangitis (PSC), a chronic liver disease with no approved therapies, is now expected in the second quarter of 2026. This is a closely watched catalyst that could unlock a significant market. Enrollment for another volixibat study in primary biliary cholangitis (PBC) is expected to complete this year, with data to follow in the first half of 2027.

Furthermore, Mirum has expedited the timeline for its LIVMARLI EXPAND study, which explores the drug's use in other cholestatic conditions. Topline data from this trial is now projected for the fourth quarter of 2026, potentially broadening the label and patient impact of its flagship product. This dual focus on nurturing existing assets while strategically acquiring new ones showcases a disciplined approach to scaling innovation in the competitive rare disease market.

Delivering Tangible Impact to Patient Communities

Beyond the financial metrics and clinical timelines, Mirum's progress in 2025 translates into tangible benefits for patients with rare diseases. The company's expansion of commercial access to 33 countries and the recent authorization by Health Canada for a new tablet formulation of LIVMARLI are critical steps in improving treatment availability and quality of life for patients globally.

Perhaps one of the most forward-looking initiatives is the recent start of a Phase 2 clinical trial for MRM-3379, an investigational oral therapy for Fragile X syndrome (FXS). FXS is the most common inherited cause of intellectual disability, yet it has no approved targeted therapies. The global market for FXS treatments was valued at over $2 billion in 2025, underscoring the immense unmet need. Mirum's entry into this field with MRM-3379, a PDE4D inhibitor designed to restore disrupted brain signaling, represents a significant long-term bet on addressing the core symptoms of a complex neurological disorder. Top-line data from this study is expected in 2027.

This patient-centric approach is central to navigating the unique landscape of rare diseases, a market valued at over $240 billion in 2025 and projected to grow at double-digit rates. Success in this sector requires more than just scientific innovation; it demands deep engagement with patient communities, a clear understanding of their needs, and the operational excellence to deliver therapies to small, geographically dispersed populations. Mirum's performance suggests it has developed a successful model for this very challenge. As stakeholders tune into the upcoming call, they will be listening for confirmation that the company's impressive run in 2025 is not just a peak, but a new foundation for sustained leadership in the rare disease space.