Mirum aims for $500M–$510M 2025 revenue as cash flow turns positive and pivotal trial readouts approach

Earnings Call Insights: Mirum Pharmaceuticals (MIRM) Q3 2025

MANAGEMENT VIEW

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CEO Christopher Peetz stated that "2025 continues to be an outstanding year for Mirum" and highlighted strong commercial results, pipeline progress, and a strengthened financial foundation. He emphasized a "nearly 50% year-over-year increase" in third quarter revenue, attributing performance to the U.S. PFIC launch and international market expansion. Peetz signaled optimism for the VISTAS Phase IIb study in PSC, with enrollment complete and top-line data expected in Q2 2026, and noted the company “recognized positive net income for the first time."

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President and COO Peter Radovich reported "total net product sales of $133 million" for Q3, driven by LIVMARLI’s performance in both U.S. and international markets. He described Alagille syndrome growth as “durable” and highlighted increased genetic screening as a key factor in PFIC market expansion. Radovich projected full-year 2025 revenue to land "in the upper end of our prior full year 2025 guidance range with $500 million to $510 million in revenues."

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Chief Medical Officer Joanne M. Quan detailed clinical pipeline progress, confirming completion of enrollment in the VISTAS PSC study and targeting enrollment completion for the EXPAND study in 2026. She shared that a case series of PSC patients on maralixibat had "meaningful reductions in pruritus and 4 of the 8 had complete resolution," supporting future IBAT inhibitor use in PSC.

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CFO Eric Bjerkholt stated, “We delivered another solid quarter of financial performance, highlighted by total net product revenue of $133 million, representing a 47% increase over the prior year." He reported GAAP profitability with approximately $3 million in net income for the quarter, noting a cash balance of $378 million at September 30.

OUTLOOK

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Radovich forecasted that Mirum expects to finish 2025 at the upper end of its guidance, stating, "we now expect to land in the upper end of our prior full year 2025 guidance range with $500 million to $510 million in revenues." He pointed to ongoing growth in the U.S. business and steady contributions from the bile acid portfolio, though flagged quarter-to-quarter variability in international distributor orders. The company continues to project substantial long-term growth, with peak revenue potential for LIVMARLI, volixibat, and MRM-3379 each exceeding $1 billion.

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The company confirmed top-line data for the VISTAS study in PSC is expected in Q2 2026, with additional pivotal readouts across the pipeline slated for the next 18 months.

FINANCIAL RESULTS

* Mirum reported Q3 net product revenue of $133 million, a 47% increase over the prior year. Operating expenses for the quarter were $130 million, including $43 million R&D, $62 million SG&A, $26 million cost of sales, $18 million noncash stock-based compensation, and $6 million intangible amortization and other noncash items. Cash, cash equivalents, and investments stood at $378 million at quarter’s end, up $85 million from the start of the year. This quarter marked the company’s first positive net income, at approximately $3 million.

Q&A

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Abdulqudus Tahlil, JPMorgan Chase & Co: Asked about LIVMARLI’s key performance drivers into 2026 and the rationale behind Q4 revenue guidance being flat sequentially. CEO Peetz said, "we are in early innings of the PFIC launch, both in the U.S. and internationally… expect that to continue to build in over time." Radovich attributed flat Q4 guidance to "variability as we move quarter-to-quarter" in international business and noted that Q3 included Takeda revenue not expected in Q4.

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Joshua Schimmer, Cantor Fitzgerald: Inquired about adoption trends for the solid tablet formulation of LIVMARLI and pricing strategy for volixibat. Radovich explained that "a substantial proportion of those who are eligible based on their weight, are switching" to the tablet and that pricing strategy for volixibat is still being analyzed.

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Gavin Clark-Gartner, Evercore: Sought clarity on Paragraph IV filers and IP confidence. Peetz responded, "we're in the window where we could potentially see that" and expressed strong confidence in Mirum’s IP position.

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Mark Hitrik, Stifel: Asked about Fragile X study endpoints and PSC safety profile. Quan reported strong engagement with FDA and patient community, and said, "no issues have been raised, no suggested modifications to the protocol" in the PSC study.

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Joseph Thome, TD Cowen: Queried on baseline criteria in PSC study and importance of secondary endpoints. Peetz said patients are "quite representative of the PSC population," with regulatory focus on pruritus as the primary endpoint.

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Ryan Deschner, Raymond James: Asked about BID dosing decision in EXPAND and impact of government shutdown. Peetz cited empirical evidence from compassionate use for BID dosing and reported "no impact" from the government shutdown.

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Ryan Mcelroy, Leerink Partners: Asked about PFIC adds and BD strategy. Radovich said PFIC adds "continue to be healthy" and Peetz noted that BD remains a high bar, with "no urgency and no need."

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Rohit Bhasin, Morgan Stanley: Asked about competitive dynamics in PBC following linerixibat’s PDUFA. Peetz highlighted volixibat’s differentiated profile and broad inclusion criteria in the VANTAGE study.

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Jonathan Wolleben, Citizens JMP Securities: Questioned on disease-modifying effects of volixibat. Quan emphasized focus on pruritus for initial approval, with longer-term endpoints to be evaluated over time.

SENTIMENT ANALYSIS

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Analyst sentiment was neutral to slightly positive, with focus on guidance details, market expansion, and competitive positioning. There was some skepticism around sequential revenue flatness in Q4 and pricing strategy, but overall tone remained constructive.

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Management’s sentiment was confident in prepared remarks, with Peetz calling 2025 “an outstanding year” and Bjerkholt highlighting "GAAP profitability" as a milestone. In Q&A, management maintained a measured, transparent tone, directly addressing questions on guidance variability and safety, and expressing confidence in IP and pipeline outlook.

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Compared to the previous quarter, management’s tone remained confident, with the addition of greater emphasis on profitability and commercial scale. Analyst tone shifted slightly toward probing for sustainability and competitive differentiation, especially regarding new launches and future growth drivers.

QUARTER-OVER-QUARTER COMPARISON

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Guidance for 2025 revenue remained within the $500 million to $510 million range, with current commentary projecting toward the upper end. Previous quarter also highlighted strong LIVMARLI and PFIC performance, but Q3 added confirmation of first-time GAAP profitability and emphasized pipeline progress, including completed enrollment in the PSC study.

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Analysts in both quarters focused on commercial execution and pipeline milestones, but Q3 included more questions about sustainability, pricing, and competitive landscape.

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Management’s confidence remained high, with Q3 remarks highlighting financial milestones and pipeline momentum. Analysts’ inquiries reflected a shift toward understanding the durability of growth and the impact of product launches and IP protection.

RISKS AND CONCERNS

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Management cited quarter-to-quarter variability in international distributor orders as a factor in revenue guidance. Radovich explained, "that business has periodic large orders from distributors, and we saw those come in, in Q3... we don't expect [Takeda revenue] in Q4."

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No material safety concerns were reported in ongoing PSC studies, with Quan stating, "no issues have been raised, no suggested modifications to the protocol."

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Analysts flagged competitive threats in PBC, pricing strategies, and the sustainability of recent gains as areas for ongoing scrutiny.

FINAL TAKEAWAY

Mirum Pharmaceuticals delivered robust commercial growth and achieved GAAP profitability for the first time, supported by strong performances from LIVMARLI and the bile acid portfolio. The company is guiding toward the upper end of its revenue range for 2025 and remains confident in the trajectory of its clinical pipeline, with multiple pivotal readouts anticipated in the next 18 months. Management emphasized its strong financial position, growing global footprint, and the scalability of its commercial model as the foundation for continued expansion and value creation.

Read the full Earnings Call Transcript [https://seekingalpha.com/symbol/mirm/earnings/transcripts]

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