Mirum Pharmaceuticals (MIRM) Company Report

Mirum Pharmaceuticals projects $500 million-$510 million in revenues for 2025, is cash flow positive, and expects continued growth across its three approved medicines.
The company initiated a Phase 2 trial for MRM-3379 in Fragile X syndrome, a condition estimated to represent a billion-plus opportunity.
An interim analysis of the Volixibat study for PSC led to the continuation of the trial with the 20 milligram dose, indicating positive progress.
Commercial growth is driven by better-than-expected identification of treatment-naive PFIC patients, contributing to outperformance against initial guidance.
Mirum holds a significant patent extending to 2040 and is prepared to defend its intellectual property against anticipated Paragraph IV filings.

3 days ago

Transcript

Mirum Pharmaceuticals Provides Business Update at HealthCONx Conference

MIRM

Guidance Update

New Projects/Investments

Legal Proceedings

Mirum Pharmaceuticals reiterated its 2025 revenue guidance of $500 million-$510 million and confirmed it is cash flow positive, anticipating continued growth from its three approved medicines.
The company initiated a Phase 2 trial for MRM-3379 in Fragile X syndrome, targeting a billion-plus market opportunity among an estimated 50,000 male patients in the US and Europe.
An interim analysis for Volixibat in PSC recommended to continue the study unchanged and selected the 20 mg dose, suggesting positive efficacy and safety thresholds were met.
Commercial performance in 2025 was significantly boosted by higher-than-expected patient identification in PFIC, a trend the company anticipates will persist.
Mirum is prepared to vigorously defend its intellectual property, specifically its 2040 method of use patent, against expected Paragraph IV filings.

3 days ago

Transcript

Mirum Pharmaceuticals Provides 2025 Revenue Guidance and Pipeline Updates

MIRM

Guidance Update

New Projects/Investments

Legal Proceedings

Mirum Pharmaceuticals provided 2025 revenue guidance of $500 million-$510 million and expects continued growth from its three approved medicines, noting it is cash flow positive.
The company announced the enrollment of the first patient in a Phase 2 trial for MRM-3379 for Fragile X syndrome, a market estimated to be a billion-plus opportunity with approximately 50,000 male patients in the U.S. and Europe.
An interim analysis for the Volixibat PSC trial resulted in the study continuing unchanged, with the 20 milligram dose selected for its therapeutic window.
Mirum outperformed its original 2025 guidance, primarily driven by identifying more naive PFIC patients than anticipated.
The company is prepared to vigorously defend its 2040 method of use patent against expected Paragraph IV filings.

3 days ago

Transcript

Mirum Pharmaceuticals Receives Generic Challenge for Livmarli

MIRM

Legal Proceedings

Mirum Pharmaceuticals, Inc. received a Paragraph IV Certification Notice Letter from Sandoz, Inc. on November 17, 2025, indicating Sandoz has submitted an Abbreviated New Drug Application (ANDA) seeking approval for a generic version of Livmarli® (maralixibat).
Sandoz alleges that five patents listed in the FDA Orange Book for Livmarli are invalid, unenforceable, or will not be infringed by its generic product.
Mirum Pharmaceuticals, Inc. intends to vigorously defend and enforce its intellectual property rights and plans to promptly file a patent infringement suit against Sandoz.
If a suit is filed within 45 days of receiving the notice, it would trigger an automatic 30-month stay, preventing the FDA from issuing final approval of Sandoz's ANDA during that period.
The company expects to receive additional Paragraph IV Certification Notice Letters in the future from other ANDA filers for Livmarli.

Nov 17, 2025, 9:52 PM

8-K

Mirum Pharmaceuticals Reports Strong Q3 Revenue and Positive Net Income, Highlights Pipeline Progress

MIRM

Earnings

Product Launch

New Projects/Investments

Mirum Pharmaceuticals reported $133 million in top-line revenue for the third quarter and achieved positive net income for the first time.
The company expects three potentially pivotal readouts over the next 18 months, including top-line data for its Volixibat PSC program in Q2 next year.
LIVMARLI's launch in PFIC has exceeded expectations, with the company approaching half of the market share in the U.S. for PFIC and projecting LIVMARLI to be an at least billion-dollar brand over time.
Volixibat is considered a blockbuster opportunity across PSC and PBC, targeting an estimated 30,000 PSC patients and 100,000 PBC patients in the U.S..

Nov 11, 2025, 1:40 PM

Transcript

Mirum Pharmaceuticals Reports Strong Q3 Performance and Outlines Pipeline Milestones

MIRM

Earnings

Guidance Update

New Projects/Investments

Mirum Pharmaceuticals announced $133 million in Q3 top-line revenue and achieved positive net income for the first time in Q3.
The company expects three potentially pivotal readouts over the next 18 months, including top-line data from its Volixibat PSC program in Q2 2026.
LIVMARLI is projected to become at least a $1 billion brand over time, with Alagille syndrome expected to contribute approximately 40% and PFIC and the "expand" indication each contributing roughly 30% of that total.
Volixibat is viewed as another blockbuster opportunity, targeting an addressable market of approximately 2/3 of 30,000 PSC patients and up to 100,000 PBC patients in the U.S..

Nov 11, 2025, 1:40 PM

Transcript

Mirum Pharmaceuticals Reports Strong Q3 2025 Results and Provides Pipeline Updates

MIRM

Earnings

Product Launch

New Projects/Investments

Mirum Pharmaceuticals reported $133 million in top-line revenue for the third quarter and achieved positive net income for the first time.
The company expects three potentially pivotal readouts over the next eighteen months, including top-line data from its PSC program with velexibat in Q2 next year (2026).
LIVMARLI's PFIC launch has exceeded expectations, and the company now believes PFIC is a larger market than initially estimated, contributing to a long-term view of LIVMARLI as at least a $1 billion brand.
Mirum anticipates Alagille syndrome to represent roughly 40% of LIVMARLI's peak sales, with PFIC and the EXPAND indication each contributing approximately 30%.
Velexibat is considered another blockbuster opportunity, with PSC representing an addressable market of roughly 30,000 patients in the U.S., of which 60% experience pruritus, and PBC having as many as 100,000 patients in the U.S..

Nov 11, 2025, 1:40 PM

Transcript

Mirum Pharmaceuticals Reports Strong Q3 Revenue and Positive Net Income, Highlights Pipeline Progress

MIRM

Earnings

Guidance Update

Mirum Pharmaceuticals reported $133 million in top-line revenue for the third quarter and achieved positive net income for the first time.
The company has three approved products and anticipates three potentially pivotal readouts over the next 18 months, including top-line data for its Volixibat PSC program in Q2 next year.
LIVMARLI is estimated to be ~50% penetrated in the U.S. for Alagille syndrome and its PFIC launch has exceeded expectations, approaching half of the market share in the U.S..
Management projects LIVMARLI to become at least a billion-dollar brand, with Alagille syndrome contributing approximately 40%, and PFIC and the 'expand' indication each contributing roughly 30%.
Volixibat is viewed as another blockbuster opportunity, targeting 30,000 PSC patients (60% with pruritus) and 100,000 PBC patients in the U.S..

Nov 11, 2025, 1:40 PM

Transcript

Mirum Pharmaceuticals Presents LIVMARLI and Volixibat Clinical Data at AASLD's The Liver Meeting®

MIRM

New Projects/Investments

Mirum Pharmaceuticals is showcasing data from its LIVMARLI (maralixibat) and volixibat clinical programs at AASLD's The Liver Meeting®, taking place from November 7-11, 2025.
A key oral presentation will feature additional analyses from the VANTAGE trial, demonstrating that volixibat leads to improvements in fatigue and sleep for adults with primary biliary cholangitis (PBC).
Several poster presentations will highlight real-world experience with maralixibat in primary sclerosing cholangitis (PSC) and the impact of maralixibat on caregiver burden for patients with Alagille Syndrome and Progressive Familial Intrahepatic Cholestasis (PFIC).
Volixibat has been granted breakthrough therapy designation for the treatment of PBC.

Nov 7, 2025, 1:10 PM

Press Release

Mirum Pharmaceuticals Reports Strong Q3 2025 Results and Raises Full-Year Guidance

MIRM

Earnings

Guidance Update

New Projects/Investments

Mirum Pharmaceuticals reported Q3 2025 revenue of $133 million, marking a nearly 50% year-over-year increase, and achieved its first positive net income of approximately $3 million.
The company raised its full-year 2025 revenue guidance to the upper end of its prior range, expecting $500-$510 million.
LIVMARLI net product sales reached $92 million in Q3 2025, with $64 million from the U.S. and $28 million internationally, while bioacquired medicines contributed $41 million.
Key pipeline advancements include expected top-line data from the VISTAS phase 2b study (Volixibat in PSC) in Q2 2026 and continued progress in the VANTAGE study (Volixibat in PBC).

Nov 4, 2025, 9:30 PM

Transcript

Earnings Transcripts

Quarterly earnings call transcripts for Mirum Pharmaceuticals.

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