MIRM Filings — Mirum Pharmaceuticals, Inc. - FilingSpy
MIRM
Mirum Pharmaceuticals, Inc.
A pharmaceutical company focused on rare diseases, it markets three FDA-approved medicines: Livmarli for the severe itching of certain inherited liver conditions, Ctexli for cerebrotendinous xanthomatosis, and Cholbam for bile acid disorders. It was founded in 2018 by a team that revived its lead drug after pharmaceutical giant Shire set it aside, and its name comes from Latin, meaning "wonder" or "marvel."
Mirum's Q2 product sales rose 38% to $176.2M, but a $16.4M IPR&D charge and $12.9M liability remeasurement loss deepened the net loss to $67.2M.
The net loss widened as acquisition costs hit the . Total product sales rose 38% to $176.2 million, driven by a 46% increase in Livmarli, but the net loss grew to $67.2 million after a $16.4 million charge for a new drug license and a $12.9 million loss on the revaluation of Bluejay acquisition liabilities. The core business is growing, but the cost of building the pipeline is now flowing through the income statement.
Key takeaways
Total product sales rose 38% to $176.2 million, with Livmarli up 46% to $128.7 million on U.S. demand for Alagille syndrome and PFIC, and Bile Acid Medicine sales up 20% to $47.5 million on new patient starts.
The net loss widened to $67.2 million from $5.9 million a year ago, driven by a $16.4 million charge for the worldwide license of zilurgisertib, a $12.9 million non-cash loss on the of Bluejay acquisition liabilities, and $11.7 million in inducement expenses from a convertible note exchange.
Section summaries
Management's Discussion and Analysis
Net loss widened to $67.2M in Q2 2026 driven by higher R&D and acquisition charges, while total product sales grew 38% to $176.2M.
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Total product sales, net rose 38% to $176.2M, with Livmarli up 46% to $128.7M on U.S. ALGS and PFIC demand and Bile Acid Medicines up 20% to $47.5M on new patient starts.
Research and development expense nearly doubled to $90.5M, primarily from $28.8M in new spending on the brelovitug (BJT-778) program acquired via Bluejay and higher personnel costs.
Research and development expense nearly doubled to $90.5 million, primarily from $28.8 million in new spending on the brelovitug program acquired with Bluejay and higher personnel costs.
Selling, general and administrative expense rose 29% to $81.5 million, reflecting higher headcount, , and commercial activities.
Unrestricted cash and investments rose to $561.3 million, bolstered by $672 million in net proceeds from new 2032 convertible notes, partially used to existing 2029 notes.
What changed
The topline data from the volixibat Phase 2b VISTAS trial in PSC, previously flagged as expected in Q2 2026, was not reported in this filing. The risk factors section now notes the FDA recommended an additional Phase 3 trial for volixibat in PSC, a new regulatory hurdle.
Livmarli sequential growth was 13.1% in Q2 2026, down from 55% in Q1 2026, which had benefited from a comparison against the prior year's -adjusted base. The Q2 pace is closer to the underlying demand trend.
The company returned to a significant net loss after nearly breaking even in Q2 2025, as the non-cash charges from the Bluejay acquisition and the zilurgisertib license flowed through the income statement.
Cash used in operations was $44.3 million, a swing from the $12.0 million generated a year ago, as operating expenses expanded with the newly acquired programs.
What to watch
Any update on the volixibat program in PSC, specifically whether the company will run the additional Phase 3 trial recommended by the FDA, and the associated timeline and cost.
Livmarli net product sales in Q3 2026, to see whether the 13% sequential growth rate holds as the launch continues to mature.
Quarterly , which turned negative again at -$44.3 million, to gauge the underlying cash burn rate now that the Bluejay and zilurgisertib costs are integrated.
Any procedural development in the consolidated Hatch-Waxman litigation, including a trial date, that could alter the March 2029 generic entry timeline for Livmarli.
Acquired IPR&D expense of $16.4M was recorded for the worldwide license of zilurgisertib, an ALK2 inhibitor for fibrodysplasia ossificans progressiva.
Selling, general and administrative expense increased 29% to $81.5M, driven by higher headcount, , and commercial activities for approved medicines.
Other expense, net of $24.2M included a $12.9M loss on Bluejay acquisition liabilities and $11.7M in inducement expenses from a convertible note exchange.
Unrestricted cash and investments rose to $561.3M as of June 30, 2026, bolstered by $672M in net proceeds from new 2032 Notes, partially used to existing 2029 Notes.
Quantitative and Qualitative Disclosures About Market Risk
Interest-rate risk is low due to short-term, high-quality holdings; foreign-currency exposure is concentrated in EUR/CHF with a ~$5.4M sensitivity.
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Cash and investments are in checking, money market funds, and highly liquid government/debt securities, with the primary objective of capital preservation.
A hypothetical 10% change in U.S. interest rates would not materially affect the of cash equivalents and investments.
The $79.0M 2029 Notes carry a fixed rate, and the $690.0M 2032 Notes bear no interest, so neither exposes the company to interest-rate risk.
Foreign-currency risk arises mainly from operations in the Netherlands, Switzerland, and other European countries, with the Euro and Swiss Franc as the primary exposures.
A near-term 10% fluctuation in the USD exchange rate could change the of net foreign-currency assets and liabilities by approximately $5.4 million.
The company holds significant cash at one financial institution in excess of federally insured limits.
From time to time, we may become involved in legal proceedings relating to claims arising from the ordinary course of business. See the information under the heading “Legal Proceedings” in Note 13 to our unaudited condensed consolidated financial statements included elsewhere in…
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From time to time, we may become involved in legal proceedings relating to claims arising from the ordinary course of business. See the information under the heading “Legal Proceedings” in Note 13 to our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q for information required to be set forth under this Item 1, which information is incorporated by reference. Our management believes that, other than as described therein, there are currently no claims or actions pending against us, the ultimate disposition of which could have a material adverse effect on our results of operations, financial condition or cash flows.
Commercialization, clinical, regulatory, financial, and IP risks threaten Mirum's approved medicines and pipeline, with new emphasis on generic litigation and tariff impacts.
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Commercial success of Livmarli, Cholbam, and Ctexli depends on maintaining adequate reimbursement, market acceptance, and a specialized sales force amid intense competition and cost-containment pressures.
Generic manufacturers have filed ANDAs for Livmarli, triggering patent litigation that could lead to early generic entry and materially harm if patents are not upheld.
Clinical development of volixibat, brelovitug, and zilurgisertib faces significant regulatory hurdles, including the FDA's recommendation for an additional Phase 3 trial for volixibat in PSC and reliance on pathways.
The company has a history of substantial net losses ($857.4M in H1 2026) and an accumulated deficit of $1.5B, requiring additional capital to fund operations and service $769M in convertible notes.
Newly emphasized risks include the potential adverse impact of U.S. and international tariffs on manufacturing costs and supply chains, and a recent FDA observation for late adverse event reporting.
Reliance on third parties for sole-source manufacturing, clinical trials, and a single specialty pharmacy creates operational vulnerabilities that could disrupt supply and commercialization.