Mirum Raises 2026 Sales Outlook After ATEBRIOZ Launch

The Tip Desk · November 3, 2026 · 3 min read

Third-quarter net product sales were $185.7 million as the rare-disease company lifted full-year guidance to $715 million to $720 million.

Mirum Pharmaceuticals (MIRM), a rare-disease company, raised its 2026 net product sales outlook to $715 million to $720 million after receiving U.S. Food and Drug Administration approval of and launching ATEBRIOZ (zilurgisertib) for fibrodysplasia ossificans progressiva.

Third-quarter global net product sales were $185.7 million, up from $176.2 million in the second quarter and $159.9 million in the first quarter. Total revenue for the quarter ended September 30, 2026 was $185.7 million, compared with $133.0 million a year earlier.

LIVMARLI (maralixibat) net product sales were $133.4 million, 45% higher than a year earlier. Bile Acid Medicines net product sales were $52.3 million, 28% higher than a year earlier. Chief Executive Officer Chris Peetz said the quarter was an important period of execution, with the ATEBRIOZ approval and launch and positive Phase 3 results across the late-stage rare liver portfolio.

The company had accepted the zilurgisertib NDA with a September 26, 2026 PDUFA date in the first quarter. It also reported positive results from Cohort 2 of the PROGRESS study of ATEBRIOZ in pediatric patients aged 6 to younger than 12 years with FOP. A supplemental NDA to expand the ATEBRIOZ indication to that pediatric group is planned for the first half of 2027.

LIVMARLI’s EXPAND Phase 3 study in additional rare cholestatic conditions, including biliary atresia, met its primary endpoint and achieved statistical significance across all prespecified secondary endpoints. A supplemental NDA for maralixibat is planned for the first half of 2027. Peetz said EXPAND results support the potential to bring LIVMARLI to more patients living with rare cholestatic liver diseases.

Brelovitug’s AZURE-1 Phase 3 study in chronic hepatitis delta virus met the primary endpoint, and the company reported positive 48-week data from the Phase 2b portion of AZURE-1 showing deepening viral suppression and increased rates of alanine aminotransferase normalization. Full AZURE-1 results were scheduled for a late-breaking poster at AASLD’s The Liver Meeting on November 8. Mirum received U.S. FDA Orphan Drug Designation for brelovitug in HDV. AZURE-4 topline data are expected in the fourth quarter of 2026, and a biologics license application is planned for the first half of 2027, subject to supportive AZURE-4 results.

Total operating expenses were $245.5 million for the quarter ended September 30, 2026, compared with $130.4 million a year earlier. Research and development expense was $93.6 million excluding stock-based compensation, including $42.1 million for brelovitug. Selling, general and administrative expense was $70.4 million excluding stock-based compensation. Cost of sales was $27.9 million excluding intangible amortization and stock-based compensation. The quarter included $13.5 million of non-recurring acquired in-process research and development expense and $40.0 million of stock-based compensation, intangible amortization, and other non-cash expenses.

The company reported an operating loss of $59.7 million and a net loss of $40.8 million, or $0.87 a share on a diluted basis, compared with operating income of $2.6 million and net income of $2.9 million, or $0.05 a share diluted, a year earlier. Weighted-average diluted shares were 66.0 million.

Unrestricted cash, cash equivalents, and investments were $500.5 million as of September 30, 2026, compared with $391.4 million as of December 31, 2025. Mirum repurchased $20.0 million aggregate principal amount of its 4.00% convertible senior subordinated notes due 2029, about 25% of the outstanding notes. It appointed Rob Myers, M.D., as Chief Medical Officer.

Volixibat VANTAGE Phase 2b topline data in primary biliary cholangitis are expected in the first quarter of 2027, and a volixibat NDA for primary sclerosing cholangitis is planned for the first half of 2027. Peetz said the milestones position Mirum for another meaningful inflection with five potential upcoming approvals and label expansions.