Mirum Pharmaceuticals, Inc.

Mirum reported Q2 2026 net product sales of $176 million, compared with $128 million in Q2 2025. Livmarli net product sales were $129 million, including $92 million in the U.S. and $37 million internationally. Rare genetics bile acid medicines generated $48 million in net product sales. The company did not provide EPS or gross margin figures on the call, but said cash contribution margin from the commercial business was in the high-50s percent in Q2 and H1, about 5 percentage points better than a year ago. Cash equivalents and investments were $561 million at June 30, versus $391 million at the beginning of the year. Full-year 2026 net product sales guidance was raised to $680 million-$700 million. Management also said the PSC NDA filing for volixibat is now targeted for 1H next year after FDA recommended a Phase 3 study; Zilurgisertib is still aimed at a September PDUFA and potential Q4 launch.

Christopher Peetz framed the quarter as evidence that Mirum is becoming a broader rare-disease leader with strong commercial execution and multiple upcoming catalysts. He emphasized that the company is advancing from a position of financial strength, with commercial cash generation supporting launches, development, and business development. On volixibat, he stressed that VISTA produced strong data and that the company believes pruritus is an approvable endpoint, but he also acknowledged the need for more dialogue with FDA to resolve the current regulatory mismatch.

Eric Bjerkholt highlighted a “strong quarter” financially, citing $176 million of net product sales versus $128 million a year earlier and a commercial cash contribution margin in the high-50s percent, about 5 points better year over year. He broke down Q2 operating expense as $290 million, including $16 million of in-process R&D tied to the Zilurgisertib licensing upfront payment, plus $76 million of R&D, $66 million of SG&A, and $23 million of cost of sales, all excluding stock comp and amortization. He also said operating cash flow was positive in the quarter and that the company strengthened its balance sheet by issuing $690 million of 0% convertible notes due 2032, with $672 million net proceeds and $197 million of cash added from settling 75% of 2029 notes.

Analysts focused heavily on the FDA’s recommendation for an additional Phase 3 study for volixibat in PSC, asking whether the issue was efficacy, safety, or team familiarity. Management said the agency was not specific, that VISTA already addressed efficacy and key safety areas, and that breakthrough designation gives them more opportunity to work through the package with FDA. Questions also probed whether a post-approval confirmatory study might suffice, whether the PSC delay changes business development, and whether VANTAGE in PBC could help support the overall package; management said pruritus is an approvable endpoint, BD remains active regardless, and VANTAGE is already positioned as a pivotal study based on prior FDA feedback. On Zilurgisertib, management said the late-cycle meeting went well and launch readiness is on track for Q4.