Mirum Pharmaceuticals, Inc.: Q1 FY2026 earnings call

What management said about Q1 FY2026, from the documents filed with the SEC on 6 May 2026: press release. Guidance figures: 1 raised, 2 new, 2 kept. The quarter’s numbers.

Read the filing

Key takeaways

• Product sales reached $159.9 million: Global net product sales were $159.9 million for the quarter, compared with $111.6 million in the first quarter of 2025. Total revenue was reported on the same basis. Source
• LIVMARLI sales up 55%: LIVMARLI net product sales were $113.8 million in the quarter, 55% above the first quarter of 2025. Source
• Volixibat met PSC primary endpoint: The Phase 2b VISTAS study of volixibat in primary sclerosing cholangitis met its primary endpoint, according to the release. Source
• Brelovitug Phase 2b met primary endpoint: The Phase 2b portion of the AZURE-1 study of brelovitug in chronic hepatitis delta virus met its primary endpoint. Source
• Zilurgisertib licensed from Incyte: Incyte received a $16 million upfront payment. It is also eligible for development and regulatory milestones, sales-based milestones, and tiered royalties in the mid-to-high single digit percent range on worldwide net sales. Source
• Bluejay in-process R&D drove expense: A non-recurring $726.3 million charge for in-process R&D came from the Bluejay Therapeutics acquisition. Total operating expenses were $949.3 million, against $126.8 million a year earlier. Source
• Cash and investments rose to $420.6M: Unrestricted cash, cash equivalents and investments were $420.6 million at March 31, 2026, against $391.4 million at December 31, 2025. Source
• Stockholders’ equity fell to $242.5M: Total stockholders’ equity was $242.5 million at March 31, 2026, against $314.7 million at December 31, 2025. The accumulated deficit rose to $1,457.7 million. Source

“2026 is off to an excellent start, driven by strong commercial momentum, the recent VISTAS and AZURE-1 topline results, disciplined clinical execution, and continued expansion of our pipeline”

Chris Peetz, Chief Executive Officer of Mirum

Guidance

What changed from last quarter

• Guidance raised: The 2026 net product sales range was raised to $660 to $680 million from $630 to $650 million. Source
• New: Mirum took an exclusive worldwide license to zilurgisertib, an ALK2 inhibitor for FOP, from Incyte. Source
• New: The FDA accepted the zilurgisertib NDA for FOP patients 12 years and older and granted Priority Review. Source

Quarterly results and net loss

• Product sales reached $159.9 million: Global net product sales were $159.9 million for the quarter, compared with $111.6 million in the first quarter of 2025. Total revenue was reported on the same basis. Source
• Net loss widened on acquired R&D: The company reported a net loss of $790.2 million, or $13.43 per share, basic and diluted, against a net loss of $14.7 million, or $0.30 per share, a year earlier. Weighted-average shares were 58.9 million. Source
• Loss from operations of $789.5 million: Loss from operations was $789.5 million, compared with $15.2 million a year earlier. Interest income was $3.4 million and interest expense was $3.6 million. Source

Product sales by franchise

• LIVMARLI sales up 55%: LIVMARLI net product sales were $113.8 million in the quarter, 55% above the first quarter of 2025. Source
• Bile Acid Medicines sales up 20%: Bile Acid Medicines net product sales were $46.1 million in the quarter, 20% above the first quarter of 2025. Source

“Zilurgisertib has completed a pivotal study for FOP and its NDA has been accepted, creating the potential for an additional product launch for our rare genetic disease team later this year.”

Chris Peetz, Chief Executive Officer of Mirum

Clinical and regulatory milestones

• Volixibat met PSC primary endpoint: The Phase 2b VISTAS study of volixibat in primary sclerosing cholangitis met its primary endpoint, according to the release. Source
• Brelovitug Phase 2b met primary endpoint: The Phase 2b portion of the AZURE-1 study of brelovitug in chronic hepatitis delta virus met its primary endpoint. Source
• Two Phase 3 enrollments now complete: Enrollment is complete in the brelovitug AZURE-1 and AZURE-4 Phase 3 studies in HDV. Topline timing is listed under guidance. Source

Zilurgisertib in-license and review

• Zilurgisertib licensed from Incyte: Incyte received a $16 million upfront payment. It is also eligible for development and regulatory milestones, sales-based milestones, and tiered royalties in the mid-to-high single digit percent range on worldwide net sales. Source
• NDA rests on PROGRESS study: The NDA filing for zilurgisertib is based on the pivotal Phase 2 PROGRESS study in FOP, which the company describes as the basis for the filing. Source
• Incyte to present PROGRESS data: Incyte plans to present the PROGRESS results at a future medical conference. No date was given in the release. Source

Operating costs and one-time charges

• Bluejay in-process R&D drove expense: A non-recurring $726.3 million charge for in-process R&D came from the Bluejay Therapeutics acquisition. Total operating expenses were $949.3 million, against $126.8 million a year earlier. Source
• Cost of sales $22.1 million: Cost of sales was $22.1 million, net of intangible amortization. Gross cost of sales, including $6.7 million of intangible amortization, was $28.8 million. Source
• R&D excluding stock compensation $73.7M: R&D expense excluding stock-based compensation was $73.7 million, of which $20.8 million related to brelovitug development. Source
• SG&A and non-cash items: SG&A excluding stock-based compensation was $63.4 million. Non-cash items totaled $63.8 million, including $34.7 million of non-recurring stock-based compensation tied to the Bluejay acquisition. Source

Cash, balance sheet and liabilities

• Cash and investments rose to $420.6M: Unrestricted cash, cash equivalents and investments were $420.6 million at March 31, 2026, against $391.4 million at December 31, 2025. Source
• Holdback liabilities on balance sheet: Holdback liabilities were $25.8 million current and $48.3 million noncurrent at March 31, 2026. The prior-year balance sheet showed none. Source
• Stockholders’ equity fell to $242.5M: Total stockholders’ equity was $242.5 million at March 31, 2026, against $314.7 million at December 31, 2025. The accumulated deficit rose to $1,457.7 million. Source
• Convertible notes still outstanding: Convertible notes payable, net, noncurrent were $310.3 million at March 31, 2026, against $309.8 million at December 31, 2025. Source

Coming up, as management said on 6 May 2026

• Volixibat full data at EASL May 30: Full VISTAS results will be presented as a late-breaking oral at the EASL Congress on May 30. The U.S. NDA submission is expected in H2 2026. Source
• Brelovitug full data at EASL May 27: Full AZURE-1 Phase 2b results will be presented as a late-breaking poster at the EASL Congress on May 27, starting 8:30 a.m. CEST. Source

Figures management reported

Earlier plans management reported on

• On track: The February release expected VISTAS topline data in Q2 2026. The May release reports the study met its primary endpoint and describes milestones as on track. Source
• Met: The February release expected EXPAND enrollment to complete in H1 2026. The May release states enrollment is complete. Source

Other quarters

• Q3 FY2026 earnings call
• Q2 FY2026 earnings call
• Q4 FY2025 earnings call
• Q3 FY2025 results

Summarised with AI from the documents the company filed with the SEC. Every point is checked against the filing before it is shown: management’s own words word for word, figures against the line or table row they come from. A point that fails the check is left out. Source opens the filing at that line.