Mirum Pharmaceuticals, Inc.
For the period ended Sep 30, 2026. Filed Nov 3, 2026.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2026 · Filed Nov 3, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2026-06-30; filed 2026-08-05.
0001759425-26-000045
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-09-30; filed 2026-11-03.
0001759425-26-000062
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 125 previous paragraphs and 134 current paragraphs.
63 unchanged; 52 reworded; 18 added; 9 removed; 1 previous and 1 current paragraphs rearranged.
Tables are not compared: 8 previous and 8 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (18)
Current report
We are a biopharmaceutical company dedicated to transforming the treatment of rare diseases. Our strategy is to acquire, develop and commercialize medicines for rare diseases, with a focus on driving commercial growth and building a diversified portfolio with meaningful value creation potential. We pursue this strategy through the growth of our marketed medicines, advancement of our development-stage portfolio, and business development, including acquisitions and in-licensing.
Current report
Our commercial organization is focused on two areas, rare liver diseases and rare genetic diseases, with dedicated field teams serving each business. Our rare liver disease business is currently our larger commercial business and is led by LIVMARLI® (maralixibat) (“Livmarli”). Our rare genetic disease business includes ATEBRIOZ® (zilurgisertib) (“Atebrioz”), CHOLBAM® (cholic acid) capsules (“Cholbam”) and CTEXLI® (chenodiol) tablets (“Ctexli”).
Current report
Rare Liver
Current report
In addition, we are developing maralixibat for certain rare cholestatic conditions through the Phase 3 EXPAND study. We announced topline results from EXPAND in October 2026 demonstrating a statistically significant improvement in pruritus compared with placebo in the primary analysis population of pediatric patients as well as in the pre-specified subgroup of biliary atresia (“BA”) patients with native livers. We plan to submit a supplemental New Drug Application (“sNDA”) for Livmarli based on the EXPAND study in the first half of 2027.
Current report
Rare Genetic
Current report
We plan to continue to expand our rare disease pipeline through business development. For example, in September 2026, we entered into a license agreement with a third party whereby we obtained the right to develop and commercialize a small molecule.
Current report
Research and development expenses were $107.9 million for the three months ended September 30, 2026, an increase of $65.0 million compared to the three months ended September 30, 2025. The increase was primarily due to:
Current report
•for other, an increase of $6.9 million primarily for additional consulting services and expenses associated with other less significant development programs as well as increased overhead costs.
Current report
Interest expense for the three months ended September 30, 2026 decreased $2.0 million compared to the three months ended September 30, 2025 primarily due to the exchange and repurchase of a portion of the 2029 Notes.
Current report
Other income, net
Current report
Results of Operations for the Nine Months Ended September 30, 2026 and 2025
Current report
Research and development expenses were $296.4 million for the nine months ended September 30, 2026, an increase of $166.3 million compared to the nine months ended September 30, 2025. The increase was primarily due to:
Current report
•for other, an increase of $12.9 million primarily for additional consulting services and expenses associated with other less significant development programs as well as increased overhead costs.
Current report
Interest expense for the nine months ended September 30, 2026 decreased $3.0 million compared to the nine months ended September 30, 2025 primarily due to the exchange and repurchase of a portion of the 2029 Notes.
Current report
Other income (expense), net
Current report
In September 2026, we used approximately $62.0 million in cash to repurchase a $20.0 million aggregate principal amount (approximately 25%) of the remaining 2029 Notes outstanding.
Current report
We may settle conversions of the Notes by paying or delivering, as applicable, cash, shares of our common stock or a combination of cash and shares of our common stock, at our election.
Current report
In September 2026, we entered into an agreement with a third party whereby we obtained the right to develop and commercialize a small molecule compound outside of China. We paid an upfront payment of $13.5 million. In addition, we are obligated to pay development and regulatory milestones of up to $32.5 million, commercial milestones of up to $525.0 million and royalties ranging from mid-single digit to low-double digit percentage range.
Removed paragraphs (9)
Previous report
We are a biopharmaceutical company dedicated to transforming the treatment of rare diseases. We have three approved medicines: LIVMARLI® (maralixibat) (“Livmarli”), Cholbam® (cholic acid) capsules (“Cholbam”), and CTEXLI® (chenodiol) tablets (“Ctexli”).
Previous report
In addition, we are developing Livmarli for certain rare cholestatic conditions through the Phase 3 EXPAND study, which we initiated in the fourth quarter of 2024. We completed enrollment of the EXPAND study in the first half of 2026 with topline data expected in the fourth quarter of 2026.
Previous report
To date, we have focused primarily on acquiring and in-licensing our product candidates, organizing and staffing our company, business planning, raising capital, advancing our product candidates through clinical development, preparing for commercialization of our product candidates, commercializing our approved medicines, and conducting business development activities relating to, among other things, portfolio expansion through collaborations and acquisitions.
Previous report
Interest Expense
Previous report
Research and development expenses were $90.5 million for the three months ended June 30, 2026, an increase of $44.5 million compared to the three months ended June 30, 2025. The increase was primarily due to:
Previous report
Other (expense) income,net
Previous report
Results of Operations for the Six Months Ended June 30, 2026 and 2025
Previous report
Research and development expenses were $188.4 million for the six months ended June 30, 2026, an increase of $101.3 million compared to the six months ended June 30, 2025. The increase was primarily due to:
Previous report
Other (expense) income,net
Reworded paragraphs (52)
Previous wording
Livmarli is a novel, orally administered, minimally-absorbed ileal bile acid transporter (“IBAT”) inhibitor (“IBATi”) that is approved for the treatment of cholestatic pruritus in patients with Alagille syndrome (“ALGS”) in the United States (“U.S.”), the European Union (“EU”) and various other countries around the world and for cholestatic pruritus in patients with progressive familial intrahepatic cholestasis (“PFIC”) in the U.S. and certain other countries and for the treatment of PFIC in the EU. We market and commercialize Livmarli in the U.S., Canada and certain countries in Europe through our specialized and focused commercial team. We have also entered into license and distribution agreements with several rare disease companies for the commercialization of Livmarli in additional countries. In March 2025, our partner Takeda received approval from the Japanese Ministry of Health, Labour, and Welfare for Livmarli for the treatment of cholestatic pruritus in patients with ALGS and PFIC.
Current wording
Livmarli (maralixibat) is a novel, orally administered, minimally-absorbed ileal bile acid transporter inhibitor (“IBATi”) that is approved for the treatment of cholestatic pruritus in patients with Alagille syndrome (“ALGS”) in the United States (“U.S.”), the European Union (“EU”) and various other countries around the world and for cholestatic pruritus in patients with progressive familial intrahepatic cholestasis (“PFIC”) in the U.S. and certain other countries and for the treatment of PFIC in the EU. We commercialize Livmarli in the U.S., Canada and certain countries in Europe and have entered into license and distribution agreements for commercialization in additional countries.
Previous wording
We are advancing our product candidate, volixibat, a novel, oral, minimally-absorbed agent designed to inhibit IBAT, for the treatment of adult patients with cholestatic liver diseases. We are developing volixibat in the setting of primary sclerosing cholangitis (“PSC”) and primary biliary cholangitis (“PBC”), and in October 2024, we announced that the FDA granted Breakthrough Therapy designation for volixibat as a potential treatment for cholestatic pruritus in patients with PBC and recently completed enrollment and expect topline data in the first quarter of 2027. We announced topline results for the VISTAS Phase 2b clinical trial in PSC in May 2026. Based on these results, FDA granted Breakthrough Therapy designation for volixibat in cholestatic pruritus due to PSC. We completed a pre-NDA meeting with FDA in which the agency recommended a Phase 3 study of volixibat in PSC. We believe the VISTAS study and supporting data can support an NDA review and we plan to discuss a potential filing package with FDA as part of our planned breakthrough therapy Type B meeting. We now expect to submit a potential New Drug Application (“NDA”) to the FDA in the first half of 2027.
Current wording
We are advancing our product candidate, volixibat, a novel, oral, minimally-absorbed IBATi, for the treatment of cholestatic pruritus in patients with primary sclerosing cholangitis (“PSC”) and primary biliary cholangitis (“PBC”), for which the U.S. Food and Drug Administration (“FDA”) has granted Breakthrough Therapy designation. We announced topline results from the VISTAS Phase 2b clinical trial in PSC in May 2026. We subsequently completed a pre-New Drug Application (“NDA”) meeting with the FDA in which the agency recommended a Phase 3 study of volixibat in PSC. We believe the VISTAS study and supporting data can support an NDA review and have ongoing interactions with the FDA, leveraging our breakthrough therapy designation. We expect to submit a potential NDA to the FDA in the first half of 2027. We expect topline data from our PBC study of volixibat in the first quarter of 2027.
Previous wording
On January 23, 2026, we completed the acquisition (the “Bluejay Acquisition”) of Bluejay Therapeutics, Inc. (“Bluejay”) and its lead product candidate brelovitug (BJT-778). We are advancing brelovitug for the treatment of chronic hepatitis D virus (“HDV”) infection. Brelovitug is a fully human IgG1 monoclonal antibody that binds the hepatitis B surface antigen, thereby clearing virions and subviral particles and preventing HDV infection and replication. Brelovitug has been granted FDA Breakthrough Therapy designation, EMA Priority Medicines (“PRIME”) scheme designation and European Commission orphan medicinal product designation. Brelovitug is currently being evaluated in the global AZURE clinical program with topline results from the AZURE-1 and AZURE-4 registration-enabling clinical trials expected in the third and fourth quarter of 2026, respectively, and top-line results from the AZURE-2 and AZURE-3 registration-enabling clinical trials expected by the first half of 2028. We believe that the results from the AZURE-1 and AZURE-4 trials may support a potential biologics license application (“BLA”) submission to the FDA for brelovitug in HDV in the first half of 2027 followed by a potential approval and subsequent commercial launch, if approved, in the second half of 2027 in the U.S.
Current wording
In January 2026, we completed the acquisition (the “Bluejay Acquisition”) of Bluejay Therapeutics, Inc. (“Bluejay”) and its lead product candidate brelovitug (BJT-778), which we are developing for chronic hepatitis D virus (“HDV”) infection. Brelovitug is a fully human IgG1 monoclonal antibody targeting hepatitis B surface antigen and has received FDA Breakthrough Therapy designation, European Medicines Agency (“EMA”) Priority Medicines (“PRIME”) scheme designation. In 2026, we announced topline results from the AZURE-1 Phase 3 study of brelovitug in HDV, which met its primary endpoint. We believe these results along with the results of AZURE-4 expected in the fourth quarter of 2026 may support a potential biologics license application (“BLA”) submission to the FDA in the first half of 2027 and, if approved, a U.S. commercial launch in the fourth quarter of 2027.
Previous wording
In April 2026, we entered into an agreement with Incyte Corporation (“Incyte”) whereby we obtained the right to develop and commercialize zilurgisertib. Zilurgisertib is an oral small molecule ALK2 inhibitor in development for the treatment of fibrodysplasia ossificans progressiva. The FDA has accepted for review Incyte’s NDA with a PDUFA date of September 26, 2026.
Current wording
In April 2026, we entered into an agreement with Incyte Corporation (“Incyte”) whereby we obtained the right to develop and commercialize zilurgisertib worldwide. Zilurgisertib is an oral small molecule ALK2 inhibitor for the treatment of fibrodysplasia ossificans progressiva (“FOP”). The FDA approved zilurgisertib in September 2026 to reduce the volume of total new heterotopic ossification (“HO”) in adult and pediatric patients aged 12 and over with FOP. We commercialize zilurgisertib in the U.S. under the brand name Atebrioz and a marketing authorization application for potential approval in Europe is in review by the EMA. We are also developing zilurgisertib for younger patients with FOP. Based on recent positive results for a cohort of patients aged 6 to less than 12 years, we expect to file an sNDA in the U.S. in the first half of 2027. A clinical study of zilurgisertib for patients younger than 6 years is ongoing.
Previous wording
We market and commercialize Ctexli and Cholbam (also known as Kolbam) (and together with chenodiol, the “Bile Acid Medicines”) in the U.S. directly and indirectly in certain foreign markets. The U.S. Food and Drug Administration (the “FDA”) approved Cholbam in March 2015, as the first FDA-approved treatment for pediatric and adult patients with bile acid synthesis disorders due to single enzyme defects, and for adjunctive treatment of patients with peroxisomal disorders, including peroxisome biogenesis disorder-Zellweger spectrum disorder (“PBD-ZSD”). Ctexli received FDA approval for the treatment of adults with cerebrotendinous xanthomatosis (“CTX”) in February 2025.
Current wording
We market and commercialize Ctexli and Cholbam (together with chenodiol, the “Bile Acid Medicines”) in the U.S. directly and indirectly in certain foreign markets. Cholbam is approved in the U.S. for pediatric and adult patients with bile acid synthesis disorders due to single enzyme defects and for adjunctive treatment of patients with peroxisomal disorders, including peroxisome biogenesis disorder-Zellweger spectrum disorder (“PBD-ZSD”). Ctexli is approved for the treatment of adults with cerebrotendinous xanthomatosis (“CTX”).
Previous wording
Our net loss was $67.2 million and $5.9 million for the three months ended June 30, 2026 and 2025, respectively, and $857.4 million and $20.5 million for the six months ended June 30, 2026 and 2025, respectively. As of June 30, 2026, we had an accumulated deficit of $1.5 billion, compared to $667.5 million as of December 31, 2025. As of June 30, 2026, we had unrestricted cash, cash equivalents and investments of $561.3 million, compared to unrestricted cash, cash equivalents and investments of $391.4 million as of December 31, 2025.
Current wording
Our net loss was $40.8 million for the three months ended September 30, 2026, our net income was $2.9 million for the three months ended September 30, 2025, and our net loss was $898.1 million and $17.6 million for the nine months ended September 30, 2026 and 2025, respectively. As of September 30, 2026, we had an accumulated deficit of $1.6 billion, compared to $667.5 million as of December 31, 2025. As of September 30, 2026, we had unrestricted cash, cash equivalents and investments of $500.5 million, compared to unrestricted cash, cash equivalents and investments of $391.4 million as of December 31, 2025.
Previous wording
We anticipate we will continue to generate net losses for the foreseeable future as we continue commercial activities for our approved medicines, conduct our ongoing and planned clinical trials, seek regulatory approvals for our product candidates and make potential milestone payments to the licensors and other third parties from whom we have in-licensed or acquired our product candidates. We expect that total product sales of our approved medicines will continue to increase on an annual basis; however, due to large periodic orders from Takeda and our distributors, our product revenue may experience quarterly fluctuations. Additionally, our product revenues from Takeda are based upon variable consideration estimates. If actual results vary from our estimates, we will make adjustments in the period when such variances become known. As a result, our net losses may fluctuate significantly from quarter-to-quarter and year-to-year.
Current wording
We anticipate we will continue to generate net losses for the foreseeable future as we continue commercial activities for our approved medicines, conduct our ongoing and planned clinical trials, seek regulatory approvals for our product candidates and make potential milestone payments to the licensors and other third parties from whom we have in-licensed or acquired our product candidates. We expect that total product sales of our approved medicines will continue to increase on an annual basis; however, due to large periodic orders from Takeda Pharmaceutical Company Limited (“Takeda”) and our distributors, our product revenue may experience quarterly fluctuations. Additionally, our product revenues from Takeda are based upon variable consideration estimates. If actual results vary from our estimates, we will make adjustments in the period when such variances become known. As a result, our net losses may fluctuate significantly from quarter-to-quarter and year-to-year.
Previous wording
We have three approved medicines: Livmarli, Cholbam and Ctexli. We expect total product sales of our approved medicines will continue to increase on an annual basis.
Current wording
We have four approved medicines: Livmarli, Cholbam, Ctexli and Atebrioz. We expect total product sales of our approved medicines will continue to increase on an annual basis.
Previous wording
Although we expect product revenues to increase as we continue commercial activities for our approved medicines, we may not achieve commercial success. Certain of our approved medicines, including the Bile Acid Medicines, are subject to immediate competition from compounded and generic entrants, as the abbreviated new drug application (“ANDA”) and NDA for these drug products have no remaining or current patent exclusivity. Chenodiol is standard of care for the treatment of CTX in the U.S. and was commercialized with a medical necessity recognition by the FDA until February 2025. We submitted an NDA for chenodiol for the treatment of CTX in 2024 and received FDA approval for the treatment of adults with CTX in February 2025, which is now commercialized under the brand name Ctexli. The FDA has granted orphan exclusivity for chenodiol for the treatment of CTX.
Current wording
Although we expect product revenues to increase as we continue commercial activities for our approved medicines, we may not achieve commercial success. Certain of our approved medicines may be subject to immediate competition from compounded and generic entrants, if the abbreviated new drug application (“ANDA”) and NDA for these drug products have no remaining or current patent exclusivity.
Previous wording
Cost of sales consist of raw materials, third-party manufacturing costs, personnel, facility and other costs of manufacturing commercial products, transportation and freight, amortization of finite-lived intangible assets and royalty payments payable on net sales of our approved medicines under licensing agreements. Cost of sales may also include period costs related to certain manufacturing services and charges for inventory valuation reserves. In addition, we have firm commitments for the purchase of minimum order quantities for active pharmaceutical ingredients (“APIs”). We periodically evaluate these firm commitments to determine if these commitments are in excess of our needs. If any net loss is determined, we record a charge to cost of sales in the period identified.
Current wording
Cost of sales consists of raw materials, third-party manufacturing costs, personnel, facility and other costs of manufacturing commercial products, transportation and freight, amortization of finite-lived intangible assets and royalty payments payable on net sales of our approved medicines under licensing agreements. Cost of sales may also include period costs related to certain manufacturing services and charges for inventory valuation reserves. In addition, we have firm commitments for the purchase of minimum order quantities for active pharmaceutical ingredients (“APIs”). We periodically evaluate these firm commitments to determine if these commitments are in excess of our needs. If any net loss is determined, we record a charge to cost of sales in the period identified.
Previous wording
We expense research and development costs as incurred. Nonrefundable advance payments for goods or services to be received in the future for use in research and development activities are recorded as prepaid expenses. The prepaid amounts are expensed as the related goods are delivered or the services are performed. Upfront payments, research and development funding and milestone payments made to third parties in connection with licenses and research and development collaborations are expensed as incurred.
Current wording
We expense research and development costs as incurred. Nonrefundable advance payments for goods or services to be received in the future for use in research and development activities are recorded as prepaid expenses. The prepaid amounts are expensed as the related goods are delivered or the services are performed.
Previous wording
For the six months ended June 30, 2026, we recorded a one-time stock-based compensation expense within research and development expense of $15.4 million related to unvested Bluejay employee stock awards which were accelerated in contemplation of the Bluejay Acquisition.
Current wording
For the nine months ended September 30, 2026, we recorded a one-time stock-based compensation expense within research and development expense of $15.4 million related to unvested Bluejay employee stock awards which were accelerated in contemplation of the Bluejay Acquisition.
Previous wording
We expect our research and development expense will increase significantly in the future, excluding the one-time stock-based compensation expense in connection with the Bluejay Acquisition discussed above, as we continue to develop our volixibat, brelovitug and MRM-3379 product candidates and execute the EXPAND label expansion study for Livmarli.
Current wording
We expect our research and development expense will increase significantly in the future, excluding the one-time stock-based compensation expense in connection with the Bluejay Acquisition discussed above, as we continue to develop our clinical product candidates.
Previous wording
For the six months ended June 30, 2026, we recorded a one-time stock-based compensation expense within selling, general and administrative expense of $19.3 million related to unvested Bluejay employee stock awards which were accelerated in contemplation of the Bluejay Acquisition.
Current wording
For the nine months ended September 30, 2026, we recorded a one-time stock-based compensation expense within selling, general and administrative expense of $19.3 million related to unvested Bluejay employee stock awards which were accelerated in contemplation of the Bluejay Acquisition.
Previous wording
We incur interest expense on our convertible notes. Interest on our convertible notes consists of a 4.00% per annum fixed rate of interest on our 4.00% convertible senior notes due 2029 (the “2029 Notes”) and amortization of debt discount and issuance costs on both the 2029 Notes and our 0.00% convertible senior notes due 2032 (the “2032 Notes”). The 2032 Notes do not have coupon interest.
Current wording
We incur interest expense on our convertible notes. Interest on our convertible notes consists of a 4.00% per annum fixed rate of interest on our 4.00% convertible senior subordinated notes due 2029 (the “2029 Notes”) and amortization of debt discount and issuance costs on both the 2029 Notes and our 0.00% convertible senior subordinated notes due 2032 (the “2032 Notes”). The 2032 Notes do not have coupon interest.
Previous wording
Other expense, net consists of gain or loss from remeasurement of the liability associated with the common stock issuable in connection with the Bluejay Acquisition after the satisfaction of certain indemnification obligations that may arise during the 12-month period following the asset acquisition date, as well as inducement expense in connection with the exchange and repurchase of a portion of the 2029 Notes in May 2026.
Current wording
Other expense, net consists of gain or loss from remeasurement of the liability associated with the common stock issuable in connection with the Bluejay Acquisition after the satisfaction of certain indemnification obligations that may arise during the 12-month period following the asset acquisition date, as well as inducement expense in connection with the exchange and repurchase of a portion of the 2029 Notes in May and September 2026.
Previous wording
There have been no significant changes during the three and six months ended June 30, 2026, except as described below, in our critical accounting policies and estimates as compared to the critical accounting policies and estimates disclosed in the section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in our Annual Report.
Current wording
There have been no significant changes during the three and nine months ended September 30, 2026, except as described below, in our critical accounting policies and estimates as compared to the critical accounting policies and estimates disclosed in the section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in our Annual Report.
Previous wording
Intangible assets are measured at their fair values as of the acquisition date or, in the case of commercial milestone payments, the date they become due. The evaluation of intangible assets includes assessing the amortization period for which the asset is expected to contribute to our future cash flows. Intangible assets with finite useful lives are amortized over their estimated useful lives on a straight-line basis. We test our finite lived intangible assets for impairment annually or if events or changes in circumstances indicate that it is more likely than not that the asset is impaired. If it is determined that the asset is impaired, the carrying value is written down to its estimated fair value, with the related impairment charge recognized in the consolidated statements of operations in the period in which the impairment occurs.
Current wording
Intangible assets are measured at their fair values as of the acquisition date. The evaluation of intangible assets includes assessing the amortization period for which the asset is expected to contribute to our future cash flows. Intangible assets with finite useful lives are amortized over their estimated useful lives on a straight-line basis. We test our finite lived intangible assets for impairment annually or if events or changes in circumstances indicate that it is more likely than not that the asset is impaired. If it is determined that the asset is impaired, the carrying value is written down to its estimated fair value, with the related impairment charge recognized in the consolidated statements of operations in the period in which the impairment occurs.
Previous wording
If it is determined that the net assets acquired do not meet the definition of a business combination under the acquisition method of accounting or if substantially all of the fair value of the gross assets acquired is concentrated in a group of similar identifiable assets, the transaction is accounted for as an asset acquisition using the cost accumulation method. In an asset acquisition, no goodwill is recognized and contingent consideration generally is not recognized at the acquisition date. Upfront payments allocated to IPR&D projects at the acquisition date and subsequent pre-commercialization milestone payments are expensed as incurred in the statements of operations unless there is an alternative future use.
Current wording
If it is determined that the net assets acquired do not meet the definition of a business combination under the acquisition method of accounting or if substantially all of the fair value of the gross assets acquired is concentrated in a group of similar identifiable assets, the transaction is accounted for as an asset acquisition using the cost accumulation method. In an asset acquisition, no goodwill is recognized and contingent consideration generally is not recognized at the acquisition date. Upfront payments allocated to IPR&D projects at the acquisition date and subsequent pre-commercialization milestone payments are expensed as incurred in the statements of operations unless there is an alternative future use. Regulatory approval and commercial milestones are recorded as intangible assets when they are paid or payable.
Previous wording
Product sales, net was $176.2 million for the three months ended June 30, 2026, compared to $127.8 million for the three months ended June 30, 2025.
Current wording
Product sales, net was $185.7 million for the three months ended September 30, 2026, compared to $133.0 million for the three months ended September 30, 2025.
Previous wording
Livmarli product sales of $128.7 million for the three months ended June 30, 2026 represented an increase of $40.6 million from the three months ended June 30, 2025. This increase was largely driven by increased sales in the U.S. for both the ALGS and especially the PFIC indications and to a lesser extent an increase in rest of world sales from direct markets and our distributors and license partner sales.
Current wording
Livmarli product sales of $133.4 million for the three months ended September 30, 2026 represented an increase of $41.2 million from the three months ended September 30, 2025. This increase was largely driven by increased sales in the U.S. for both the ALGS and especially the PFIC indications and to a lesser extent an increase in rest of world sales from direct markets and our distributors and license partner sales.
Previous wording
Bile Acid Medicines sales of $47.5 million for the three months ended June 30, 2026, represented an increase of $7.9 million from the three months ended June 30, 2025. This increase was driven by new patient starts for both Cholbam and Ctexli.
Current wording
Bile Acid Medicines sales of $52.3 million for the three months ended September 30, 2026 represented an increase of $11.5 million from the three months ended September 30, 2025. This increase was driven by new patient starts for both Cholbam and Ctexli.
Previous wording
For the three months ended June 30, 2026, cost of sales was $30.3 million, compared to $23.4 million for the three months ended June 30, 2025. The increase in cost of sales was primarily a result of increases in royalty expenses of $5.0 million on net sales of Livmarli and the Bile Acid Medicines under licensing agreements and $1.1 million of general supply chain support costs.
Current wording
For the three months ended September 30, 2026, cost of sales was $35.2 million, compared to $25.5 million for the three months ended September 30, 2025. The increase in cost of sales was primarily a result of increases in royalty expenses of $7.7 million on net sales of Livmarli and the Bile Acid Medicines under licensing agreements and $1.2 million of general commercial and supply chain support costs.
Previous wording
•for brelovitug, an increase of $28.8 million primarily related to expenses associated with clinical manufacturing and BLA enabling activities and expenses associated with conduct of the AZURE clinical trials; and
Current wording
•for brelovitug, an increase of $42.1 million primarily related to expenses associated with clinical manufacturing and BLA enabling activities and expenses associated with conduct of the AZURE clinical trials;
Previous wording
•for personnel related and stock-based compensation expenses, an aggregate increase of $9.6 million, due to increased employee headcount and equity award grants, including incremental headcount assumed in our acquisition of Bluejay, to support our development pipeline.
Current wording
•for personnel related and stock-based compensation expenses, an aggregate increase of $16.1 million, due to increased employee headcount and equity award grants, including incremental headcount assumed in our acquisition of Bluejay, to support our development pipeline; and
Previous wording
During the three months ended June 30, 2026, we recorded a $16.4 million charge, representing an acquired IPR&D asset with no alternative future use related to the license of worldwide rights to zilurgisertib.
Current wording
During the three months ended September 30, 2026, we recorded a $13.5 million charge, representing an acquired IPR&D asset with no alternative future use related to an agreement with a third party for the development and commercialization of a clinical stage small molecule compound.
Previous wording
Selling, general and administrative expenses were $81.5 million for the three months ended June 30, 2026, an increase of $18.2 million compared to the three months ended June 30, 2025. The increase was primarily due to an increase of $8.2 million in personnel and other compensation related expenses, including an increase of $5.3 million in stock-based compensation, reflecting an increase in the number of our selling, marketing and administrative employees to support commercial activities for our approved medicines, $5.9 million sales, marketing and advertising expenses, $2.4 million of legal, accounting and other outside services and $1.9 million associated with the Mirum Access Plus patient services program.
Current wording
Selling, general and administrative expenses were $88.9 million for the three months ended September 30, 2026, an increase of $27.0 million compared to the three months ended September 30, 2025. The increase was primarily due to an increase of $13.2 million in personnel and other compensation related expenses, including an increase of $6.3 million in stock-based compensation, reflecting an increase in the number of our selling, marketing and administrative employees to support commercial activities for our approved medicines, $9.2 million sales, marketing and advertising expenses, $2.9 million of legal, accounting and other outside services and $2.8 million associated with the Mirum Access Plus patient services program.
Previous wording
Other (expense) income, net for the six months ended June 30, 2026 was an expense primarily related to the fair value remeasurement of the liability associated with stock issuable in the Bluejay Acquisition of $11.9 million and inducement expenses of $11.7 million incurred in connection with the exchange and repurchase of a portion of the 2029 Notes.
Current wording
Other income, net for the three months ended September 30, 2026 was an income primarily related to the remeasurement of the fair value of the liability associated with stock issuable in the Bluejay Acquisition of $16.5 million.
Previous wording
The following table summarizes our results of operations for the six months ended June 30, 2026 and 2025 (in thousands):
Current wording
The following table summarizes our results of operations for the nine months ended September 30, 2026 and 2025 (in thousands):
Previous wording
Product sales, net was $336.1 million for the six months ended June 30, 2026, compared to $239.4 million for the six months ended June 30, 2025.
Current wording
Product sales, net was $521.8 million for the nine months ended September 30, 2026, compared to $372.4 million for the nine months ended September 30, 2025.
Previous wording
Livmarli product sales of $242.5 million for the six months ended June 30, 2026 represented an increase of $81.1 million from the six months ended June 30, 2025. This increase was largely driven by increased sales in the U.S. for both the ALGS and especially the PFIC indications and to a lesser extent an increase in rest of world sales from direct markets and our distributors and license partner sales.
Current wording
Livmarli product sales of $376.0 million for the nine months ended September 30, 2026 represented an increase of $122.4 million from the nine months ended September 30, 2025. This increase was largely driven by increased sales in the U.S. for both the ALGS and especially the PFIC indications and to a lesser extent an increase in rest of world sales from direct markets and our distributors and license partner sales.
Previous wording
Bile Acid Medicines sales of $93.6 million for the six months ended June 30, 2026 represented an increase of $15.6 million from the six months ended June 30, 2025. This increase was driven by new patients for both Cholbam and Ctexli.
Current wording
Bile Acid Medicines sales of $145.9 million for the nine months ended September 30, 2026 represented an increase of $27.1 million from the nine months ended September 30, 2025. This increase was driven by new patients for both Cholbam and Ctexli.
Previous wording
For the six months ended June 30, 2026, cost of sales was $59.2 million, compared to $46.4 million for the six months ended June 30, 2025. The increase in cost of sales was primarily a result of increases in royalty expenses of $10.1 million on net sales of Livmarli and the Bile Acid Medicines under licensing agreements, $2.9 million of general supply chain support costs and amortization expense of $1.6 million associated with capitalized sales milestone payments under our license agreements. These increases were partially offset by a $2.3 million decrease primarily associated with excess purchase commitments for APIs associated with Ctexli, which were recorded during the six months ended June 30, 2025.
Current wording
For the nine months ended September 30, 2026, cost of sales was $94.3 million, compared to $72.0 million for the nine months ended September 30, 2025. The increase in cost of sales was primarily a result of increases in royalty expenses of $17.8 million on net sales of Livmarli and the Bile Acid Medicines under licensing agreements, $4.1 million of general commercial and supply chain support costs and amortization expense of $2.4 million associated with capitalized sales milestone payments under our license agreements. These increases were partially offset by a $2.1 million decrease primarily associated with excess purchase commitments for APIs associated with Ctexli, which were recorded during the nine months ended September 30, 2025.
Previous wording
•for volixibat programs, an increase of $8.2 million, primarily due to increased expenses associated with conduct of the PBC trial;
Current wording
•for volixibat programs, an increase of $7.8 million, primarily due to increased expenses associated with conduct of the PBC trial;
Previous wording
•for MRM-3379, an increase of $5.4 million, primarily due to our Phase 2 study in FXS and non-clinical studies;
Current wording
•for MRM-3379, an increase of $4.8 million, primarily due to our Phase 2 study in FXS and related support studies;
Previous wording
•for brelovitug, which we acquired during the six months ended June 30, 2026, an increase of $49.6 million primarily related to expenses associated with clinical manufacturing and BLA enabling activities and expenses associated with conduct of the AZURE clinical trials; and
Current wording
•for brelovitug, which we acquired during the nine months ended September 30, 2026, an increase of $91.6 million primarily related to expenses associated with clinical manufacturing and BLA enabling activities and expenses associated with conduct of the AZURE clinical trials;
Previous wording
•for personnel related and stock-based compensation expenses, an aggregate increase of $34.5 million, of which $15.4 million is due to a one-time expense relating to unvested Bluejay employee stock awards which were accelerated in contemplation of the Bluejay Acquisition and $19.1 million due to increased employee headcount and equity award grants to support our development pipeline.
Current wording
•for personnel related and stock-based compensation expenses, an aggregate increase of $50.6 million, of which $15.4 million is due to a one-time expense relating to unvested Bluejay employee stock awards which were accelerated in contemplation of the Bluejay Acquisition and $35.2 million due to increased employee headcount and equity award grants to support our development pipeline; and
Previous wording
During the six months ended June 30, 2026, we recorded a $742.7 million charge, representing an acquired IPR&D asset with no alternative future use of $726.3 million and $16.4 million related to the Bluejay Acquisition and the agreement with Incyte, respectively. In comparison, acquired IPR&D for the six months ended June 30, 2025 includes a development milestone payment associated with our EXPAND study.
Current wording
During the nine months ended September 30, 2026, we recorded a $756.2 million charge, representing an acquired IPR&D asset with no alternative future use of $726.3 million related to the Bluejay Acquisition, $16.4 million related to the agreement with Incyte, and $13.5 million related to an agreement with a third party for the development and commercialization of a clinical stage small molecule compound. In comparison, acquired IPR&D for the nine months ended September 30, 2025 includes a development milestone payment associated with our EXPAND study.
Previous wording
Selling, general and administrative expenses were $177.8 million for the six months ended June 30, 2026, an increase of $56.8 million compared to the six months ended June 30, 2025. The increase was primarily due to a $19.3 million one-time expense relating to consideration paid to employees of Bluejay for unvested equity awards recognized as post-combination stock-based compensation expense, increases of $16.8 million in personnel and other compensation related expenses, including an increase of $8.7 million in stock-based compensation, reflecting an increase in the number of our selling, marketing and administrative employees to support commercial activities for our approved medicines, $11.2 million sales, marketing and advertising expenses, $6.8 million of legal, accounting and other outside services and $2.7 million associated with the Mirum Access Plus patient services program.
Current wording
Selling, general and administrative expenses were $266.7 million for the nine months ended September 30, 2026, an increase of $83.8 million compared to the nine months ended September 30, 2025. The increase was primarily due to increases of $30.0 million in personnel and other compensation related expenses, including an increase of $15.0 million in stock-based compensation, reflecting an increase in the number of our selling, marketing and administrative employees to support commercial activities for our approved medicines, $20.5 million sales, marketing and advertising expenses, a $19.3 million one-time expense relating to consideration paid to employees of Bluejay for unvested equity awards recognized as post-combination stock-based compensation expense, $9.8 million of legal, accounting and other outside services and $5.5 million associated with the Mirum Access Plus patient services program.
Previous wording
Other (expense) income, net for the three months ended June 30, 2026 was an expense primarily related to the remeasurement of the fair value of the liability associated with stock issuable in the Bluejay Acquisition of $12.9 million and inducement expenses of $11.7 million incurred in connection with the exchange and repurchase of a portion of the 2029 Notes.
Current wording
Other income (expense), net for the nine months ended September 30, 2026 was an expense primarily related to the inducement expenses of $11.7 million incurred in connection with the exchange and repurchase of a portion of the 2029 Notes partially offset by the net gain from fair value remeasurement of the liability associated with stock issuable in the Bluejay Acquisition of $4.6 million.
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Current report — wording carried from elsewhere
Net Cash (Used in) Provided by Operating Activities
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Previous report — wording carried elsewhere
Net Cash Used in Operating Activities