Mirum Raises 2026 Sales Guidance To $715 Million-$720 Million As Quarterly Loss Hits $40.8 Million
The rare disease drugmaker posted a third-quarter loss as R&D spending climbed, even as net product sales grew to $185.7 million.
Mirum Pharmaceuticals, a rare disease drugmaker, raised its 2026 net product sales guidance to $715 million to $720 million on Tuesday, while reporting a third-quarter net loss of $40.8 million against net income of $2.9 million a year earlier.
Sales up, spending up faster
Third-quarter net product sales reached $185.7 million, up from $133.0 million a year earlier, the company reported. Livmarli sales were $133.4 million, up 45% from the third quarter of 2025, and its bile acid medicines brought in $52.3 million, up 28%.
Operating expenses rose to $245.5 million from $130.4 million. Research and development expense was $107.9 million, against $43.0 million a year earlier, and included $42.1 million for brelovitug, the hepatitis delta antibody. A $13.5 million charge for acquired in-process research and development also hit the quarter. The net loss worked out to $0.87 per diluted share.
For the first nine months, the company reported a net loss of $898.1 million, with acquired in-process research and development expense of $756.2 million.
A rare liver disease portfolio
Mirum sells Livmarli for itching caused by Alagille syndrome and progressive familial intrahepatic cholestasis, along with Cholbam and Ctexli. The company said it received FDA approval of and launched Atebrioz, a drug it licensed from Incyte, for fibrodysplasia ossificans progressiva, a condition in which bone forms in soft tissue.
CEO Chris Peetz said the quarter brought "positive Phase 3 results across our late-stage rare liver portfolio." The company reported that its Phase 3 AZURE-1 study of brelovitug in hepatitis delta met its main goal, and that Livmarli's Phase 3 EXPAND study, which covers biliary atresia, did too. Brelovitug also received FDA Orphan Drug Designation.
Cash, notes and the next readouts
Mirum held $500.5 million in unrestricted cash, cash equivalents and investments at September 30, compared with $391.4 million at December 31, 2025. It repurchased $20.0 million of its 4.00% convertible notes due 2029, about 25% of the outstanding notes.
Full AZURE-1 results will be presented at the AASLD Liver Meeting on November 8. Topline data from the Phase 3 AZURE-4 study are expected in the fourth quarter of 2026.
Mirum plans a brelovitug license application in the first half of 2027, subject to supportive AZURE-4 results.
Sources
- 8-K Filing — Mirum Pharmaceuticals, Inc. (MIRM) — SEC EDGAR
- Exhibit mirm-20261103xexx991.htm — Mirum Pharmaceuticals, Inc. 8-K exhibit — SEC EDGAR
More on Mirum Pharmaceuticals
- No Treated Child Developed New Bone Lesions In Mirum's FOP Trial, While One On Placebo Did
- Mirum's Livmarli Cuts Itch Versus Placebo In 52-Patient Phase 3 Trial, Sets 2027 Filing Plan
- FDA Clears Mirum's Atebrioz For Rare Bone-Hardening Disease, And A Separate Hepatitis Delta Trial Hits Its Primary Goal
