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Mirum Pharmaceuticals, Inc.

For the period ended Jun 30, 2026. Filed Aug 5, 2026.

View on SEC.gov

About this filing

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.

Jun 30, 2026 · Filed Aug 5, 2026

MIRM$93.72+0.2%Stored close · as of Nov 6, 2026

What changed in Management’s Discussion and Analysis?

Read the current filing

Previous report: 10-Q

Period ended 2026-03-31; filed 2026-05-06.

0001759425-26-000037

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Current 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 Operations

The 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 110 previous paragraphs and 125 current paragraphs.

68 unchanged; 32 reworded; 17 added; 8 removed; 2 previous and 8 current paragraphs rearranged.

Tables are not compared: 4 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 (17)

Current report

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 report

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 report

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 report

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 report

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 report

Results of Operations for the Six Months Ended June 30, 2026 and 2025

Current report

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 report

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 report

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 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:

Current report

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 report

In May 2026, we issued $690.0 million aggregate principal amount of our 2032 Notes. Net proceeds from this offering, after deducting the initial purchasers’ discounts and commissions and offering expenses, were approximately $672.0 million. We used approximately $474.7 million of the net proceeds and issued 3,220,529 shares of common stock to repurchase $237.2 million aggregate principal of the 2029 Notes. The result of these transactions resulted in an increase of approximately $197.3 million to our unrestricted cash, cash equivalents and investments balance.

Current report

The Notes are classified as long term liabilities in our condensed consolidated balance sheets. See Note 9 to our accompanying Condensed Consolidated Financial Statements for additional discussion on our convertible notes.
Removed paragraphs (8)

Previous report

Product sales, net was $159.9 million for the three months ended March 31, 2026, compared to $111.6 million for the three months ended March 31, 2025. The increase in product sales, net was a result of our continued commercialization of Livmarli in the U.S. for the treatment of ALGS and PFIC, and in certain international markets directly or through distributor and licensed partner orders and from our sales of the Bile Acid Medicines.

Previous report

•for Livmarli, a decrease of $1.6 million, primarily due to lower costs from the PFIC rollover study and other clinical costs partially offset by increased expenses associated with the Livmarli Phase 3 EXPAND label expansion study.

Previous report

In April 2023, we completed an offering of $316.3 million aggregate principal of the Notes, which includes the exercise of the initial purchasers’ option in full. The offering resulted in net proceeds of $305.3 million after deducting the initial purchasers’ discounts and commissions and offering expenses. The Notes are our senior, unsecured obligations and accrue interest at a rate of 4.00% per annum, payable semi-annually in arrears on May 1 and November 1 of each year. The Notes will mature on May 1, 2029, unless earlier converted, redeemed or repurchased by us. The terms of these Notes are further described in Note 9 to our unaudited condensed consolidated financial statements.

Previous report

During the first quarter of 2026, the last reported sale price of our common stock exceeded 130% of the conversion price of the Notes for more than 20 trading days during the 30 consecutive trading days ended March 31, 2026. As a result, the Notes are convertible at the option of the holders of the Notes during the second quarter of 2026, the quarter immediately following the quarter when the conditions were met, as stated in the terms of the Notes. If holders of the Notes elect to convert their Notes, we may elect to settle such conversions by paying or delivering, as applicable, cash, shares of our common stock or a combination of cash and shares of our common stock. During the three months ended March 31, 2026 and through the date of this filing, the amount of the principal balance of the Notes that has been converted was not material.
Reworded paragraphs (32)

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., Canada and Japan 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 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.

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. We announced topline results for the VISTAS Phase 2b clinical trial in PSC in May 2026. Based on these topline results, we expect to submit a New Drug Application (“NDA”) to the FDA for volixibat for the treatment cholestatic pruritus in PSC in the second half of 2026, with both potential approval and subsequent launch of volixibat for the treatment of cholestatic pruritus in PSC, if approved, to occur in the first half of 2027. We reported interim data from our VANTAGE Phase 2b clinical trial in PBC in June 2024 and expect the clinical trial to complete enrollment in the second half of 2026 with topline data expected in the first quarter of 2027.

Current 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.

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 second half of 2026 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

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.

Previous wording

In April 2026, we entered into an agreement with Incyte Corporation (“Incyte”) whereby we obtained the right to commercialize zilurgisertib upon FDA approval. 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. 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.

Previous wording

Our net loss was $790.2 million and $14.7 million for the three months ended March 31, 2026 and 2025, respectively. As of March 31, 2026, we had an accumulated deficit of $1.5 billion, compared to $667.5 million as of December 31, 2025. As of March 31, 2026, we had unrestricted cash, cash equivalents and investments of $420.6 million, compared to unrestricted cash, cash equivalents and investments of $391.4 million as of December 31, 2025.

Current 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.

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, including the clinical trials for brelovitug, 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 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

Our U.S. revenue from product sales, net further depends on our prescription mix of commercial payors, Medicaid and amounts of free medicines provided under our patient assistance program. We expect our prescription mix and resulting gross to net adjustment in the U.S. to remain materially consistent. Our revenue from product sales is recognized when the control of the product is transferred. Under our license agreement with Takeda as well as agreements with distributors, we may receive large periodic orders for our products. The timing of these orders can be inconsistent and can create significant quarter-to-quarter variation in product sales. In addition, we recognize our best estimate of the consideration that we expect to receive when control of the inventory is transferred to our licensed partners and distributors. Such estimates may be complex and include estimates as to if and when our distributors and licensed partner’s sales in the market will occur. Estimates are reviewed and updated quarterly as additional information, including in-market pricing and sales information of our authorized distributors and licensed partners, becomes known which may cause variability of quarterly revenue particularly during periods of product launch.

Current wording

Our U.S. revenue from product sales, net further depends on our prescription mix of commercial payors and governmental programs. We expect our prescription mix and resulting gross to net adjustment in the U.S. to remain materially consistent. Our revenue from product sales is recognized when the control of the product is transferred. Under our license agreement with Takeda as well as agreements with distributors, we may receive large periodic orders for our products. The timing of these orders can be inconsistent and can create significant quarter-to-quarter variation in product sales. In addition, we recognize our best estimate of the consideration that we expect to receive when control of the inventory is transferred to our licensed partners and distributors. Such estimates may be complex and include estimates as to if and when our distributors and licensed partner’s sales in the market will occur. Estimates are reviewed and updated quarterly as additional information, including in-market pricing and sales information of our authorized distributors and licensed partners, becomes known which may cause variability of quarterly revenue particularly during periods of product launch.

Previous wording

For the three months ended March 31, 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 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.

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 develop brelovitug and continue to develop our volixibat 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 volixibat, brelovitug and MRM-3379 product candidates and execute the EXPAND label expansion study for Livmarli.

Previous wording

For the three months ended March 31, 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 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.

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 and amortization of debt discount and amortization costs.

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 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.

Previous wording

There have been no significant changes during the three months ended March 31, 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 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.

Previous wording

In connection with certain acquisitions, we may be required to pay future consideration that is contingent upon the achievement of specified development, regulatory approval or sales-based milestone events. Contingent consideration resulting from a business combination is recorded at its fair value on the acquisition date. Each reporting period thereafter, these obligations are revalued and increases or decreases in their fair value are recorded in the statement of operations until such time that the payment is made.

Current wording

In connection with certain acquisitions, we may be required to pay future consideration that is contingent upon the achievement of specified development, regulatory approval or sales-based milestone events. Contingent consideration resulting from a business combination is recorded at its fair value on the acquisition date. Each reporting period thereafter, these obligations are revalued and increases or decreases in their fair value are recorded in the statements of operations until such time that the payment is made.

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 statement 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.

Previous wording

Research and development expenses were $97.9 million for the three months ended March 31, 2026, an increase of $56.9 million compared to the three months ended March 31, 2025. The increase was primarily due to:

Current wording

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 wording

For the three months ended March 31, 2026, cost of sales was $28.8 million, compared to $23.0 million for the three months ended March 31, 2025. The increase in cost of sales was primarily a result of increases in royalty expenses of $5.1 million on net sales of Livmarli and the Bile Acid Medicines under licensing agreements and $1.8 million of general supply chain support costs. 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 three months ended March 31, 2025.

Current 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.

Previous wording

•for volixibat programs, an increase of $5.6 million, primarily due to increased expenses associated with conduct of the PSC and PBC trials;

Current wording

•for volixibat programs, an increase of $8.2 million, primarily due to increased expenses associated with conduct of the PBC trial;

Previous wording

•for MRM-3379, an increase of $4.2 million, primarily due to our Phase 2 study in FXS and non clinical studies;

Current wording

•for MRM-3379, an increase of $5.4 million, primarily due to our Phase 2 study in FXS and non-clinical studies;

Previous wording

•for brelovitug, which we acquired during the three months ended March 31, 2026, an increase of $20.8 million primarily related to expenses associated with expenses for 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 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

Previous wording

•for personnel related and stock-based compensation expenses, an aggregate increase of $25.7 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 $10.3 million due to increased employee headcount and equity award grants to support our development pipeline; partially offset by

Current 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.

Previous wording

During the three months ended March 31, 2026, we recorded a $726.3 million charge, representing an acquired IPR&D asset with no alternative future use related to the Bluejay Acquisition. In comparison, acquired IPR&D for the three months ended March 31, 2025 includes a development milestone payment associated with our EXPAND study achieved in the three months ended March 31, 2025.

Current 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.

Previous wording

Selling, general and administrative expenses were $96.3 million for the three months ended March 31, 2026, an increase of $38.6 million compared to the three months ended March 31, 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 $8.5 million in personnel and other compensation related expenses, including an increase of $3.4 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, $5.1 million sales, marketing and advertising expenses, and $4.5 million of legal, accounting and other outside services.

Current 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.

Previous wording

Since inception, we have funded our operations primarily through debt, equity, revenue interest financings and cash from our product sales and license and collaboration revenue. We had $420.6 million of unrestricted cash, cash equivalents and investments as of March 31, 2026, compared to unrestricted cash, cash equivalents and investments of $391.4 million as of December 31, 2025. We have incurred significant operating losses since our inception. As of March 31, 2026, we had an accumulated deficit of $1.5 billion, compared to $667.5 million as of December 31, 2025.

Current wording

Since inception, we have funded our operations primarily through debt, equity, revenue interest financings and cash from our product sales and license and collaboration revenue. We had $561.3 million of unrestricted cash, cash equivalents and investments as of June 30, 2026, compared to unrestricted cash, cash equivalents and investments of $391.4 million as of December 31, 2025. We have incurred significant operating losses since our inception. As of June 30, 2026, we had an accumulated deficit of $1.5 billion, compared to $667.5 million as of December 31, 2025.

Previous wording

In addition to ongoing capital needs to fund our ongoing operations, our material cash requirements include the following contractual and other obligations.

Current wording

In addition to ongoing capital needs to fund our ongoing operations, our material cash requirements include the following obligations for the Notes as of June 30, 2026:

Previous wording

In January 2026, we completed the acquisition of Bluejay. In addition to the consideration paid at closing, we are obligated to pay up to an aggregate of $25.8 million in cash and 522,375 shares of Company common stock, subject to deduction for taxes and certain holdbacks, and up to an aggregate of $200.0 million upon achievement of certain commercial milestones.

Current wording

In January 2026, we completed the acquisition of Bluejay. In addition to the consideration already paid, as of June 30, 2026, we are obligated to pay up to $24.8 million in cash and 522,375 shares of Company common stock, subject to deduction for taxes and certain holdbacks, and up to an aggregate of $200.0 million upon achievement of certain commercial milestones.

Previous wording

In April 2026, we entered into an agreement with Incyte whereby we obtained the right to commercialize zilurgisertib upon FDA approval. Zilurgisertib is an oral small molecule ALK2 inhibitor in development for the treatment of fibrodysplasia ossificans progressiva. We paid an upfront payment of $16.0 million. In addition, the Company is obligated to pay royalties in the mid-to-high single digit percentage range and additional regulatory milestones of up to $48.0 million and commercial milestones of up to $15.0 million.

Current wording

In April 2026, we entered into an agreement with 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. We paid an upfront payment of $16.0 million. In addition, the Company is obligated to pay royalties in the mid-to-high single digit percentage range and additional regulatory milestones of up to $48.0 million, including $25.0 million upon FDA approval, and commercial milestones of up to $15.0 million.

Previous wording

Net cash used in operating activities was $228.8 million for the three months ended March 31, 2026, reflecting our net loss of $790.2 million partially offset by adjustments of $459.2 million. Adjustments consisted primarily of the fair value of common stock issued as consideration in an asset acquisition, stock-based compensation, depreciation and amortization of our intangible assets and fixed assets. Additionally, cash used in operating activities reflected a cash inflow for changes in net operating assets and liabilities of $102.2 million, primarily related to an increase in holdback liabilities payable in connection with our acquisition of Bluejay, an increase in accounts payable, accrued clinical trial and contract manufacturing costs with the addition of brelovitug to our development pipeline and an increase of sales deductions due to the growth from our product sales. This net inflow from change in operating liabilities was partially offset by an increase in accounts receivable related to the growth in our product sales and an increase in prepaid and other current assets related to assets acquired in the Bluejay acquisition.

Current wording

Net cash used in operating activities was $273.0 million for the six months ended June 30, 2026, reflecting our net loss of $857.4 million partially offset by adjustments of $522.4 million. Adjustments consisted primarily of the fair value of common stock issued as consideration in an asset acquisition, stock-based compensation, depreciation and amortization of our intangible assets and fixed assets, debt conversion inducement expense related to the exchange and repurchase of a portion of the 2029 Notes and change in fair value of the holdback liabilities related to our acquisition of Bluejay. Additionally, cash used in operating activities reflected a cash inflow for changes in net operating assets and liabilities of $62.0 million, primarily related to an increase in holdback liabilities payable in connection with our acquisition of Bluejay, an increase in accounts payable, accrued clinical trial and contract manufacturing costs with the addition of brelovitug to our development pipeline and an increase of sales deductions due to the growth from our product sales. This net inflow from change in operating liabilities was partially offset by an increase in accounts receivable related to the growth in our product sales and an increase in prepaid and other current assets related to assets acquired in the Bluejay Acquisition.

Previous wording

Net cash used in operating activities was $2.0 million for the three months ended March 31, 2025, reflecting our net loss of $14.7 million partially offset by adjustments of $24.0 million. Adjustments consisted primarily of stock-based compensation, depreciation and amortization of our intangible assets and fixed assets, and charges associated with excess and obsolete inventory and firm commitment losses. Additionally, cash used in operating activities reflected changes in net operating assets of $11.3 million, primarily related to the increase in accounts payable, accrued expenses and other liabilities resulting primarily from an increase in accrued sales deductions and royalties due to the growth from our product sales in the three months ended March 31, 2025, and an increase in accrued expenses related to clinical studies and contract manufacturing activities driven by our growth, offset by payments made for the purchase of inventory.

Current wording

Net cash provided by operating activities was $10.1 million for the six months ended June 30, 2025, reflecting our net loss of $20.5 million, partially offset by adjustments of $48.5 million. Adjustments consisted primarily of stock-based compensation, depreciation and amortization of our intangible assets and fixed assets, and charges associated with excess and obsolete inventory and firm commitment losses. Additionally, cash provided by operating activities reflected changes in net operating assets of $17.9 million, primarily related to an increase in accounts receivable and payments made for inventory, prepaid assets and accrued compensation and related benefits partially offset by an increase in accrued sales deductions and royalties due to the growth from our product sales in the six months ended June 30, 2025 and an increase in accrued clinical trial and contract manufacturing expenses during the period.

Previous wording

Net cash used in investing activities was $11.6 million for the three months ended March 31, 2026, primarily due to purchases of investments and the payment of a commercial milestone achieved in 2025, partially offset by proceeds from maturities of investments.

Current wording

Net cash used in investing activities was $171.6 million for the six months ended June 30, 2026, primarily due to purchases of investments and the payment of commercial milestones achieved in 2025, partially offset by proceeds from maturities of investments.

Previous wording

Net cash used in investing activities for the three months ended March 31, 2025 was $16.1 million primarily due to purchases of investments, offset by proceeds from maturities of investments.

Current wording

Net cash used in investing activities for the six months ended June 30, 2025 was $22.7 million primarily due to purchases of investments, partially offset by proceeds from maturities of investments.

Previous wording

Net cash provided by financing activities was $270.1 million for the three months ended March 31, 2026, due to proceeds from issuance of common stock and pre-funded warrants in a private placement and proceeds from employee equity award exercises.

Current wording

Net cash provided by financing activities was $481.5 million for the six months ended June 30, 2026, due to proceeds from issuance of the 2032 Notes, proceeds from issuance of common stock and pre-funded warrants in a private placement and proceeds from employee equity award exercises. The net cash provided by those transactions was partially offset by cash used in the repurchase of a portion of the 2029 Notes.

Previous wording

Net cash provided by financing activities was $6.4 million for the three months ended March 31, 2025, due to proceeds from employee equity award exercises.

Current wording

Net cash provided by financing activities was $15.0 million for the six months ended June 30, 2025, due to proceeds from employee equity award exercises.
Rearranged current paragraphs (8)

Current report — wording carried from elsewhere

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 report — wording carried from elsewhere

•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 report — wording carried from elsewhere

•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 report — wording carried from elsewhere

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 report — wording carried from elsewhere

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 report — wording carried from elsewhere

The following table summarizes our results of operations for the six months ended June 30, 2026 and 2025 (in thousands):

Current report — wording carried from elsewhere

The following table disaggregates total Product sales, net (in thousands):

Current report — wording carried from elsewhere

The following table summarizes the period-over-period changes in research and development expenses relating to our product candidates in development for the periods indicated (in thousands):
Rearranged previous paragraphs (2)

Previous report — wording carried elsewhere

Acquired in-process research and development

Previous report — wording carried elsewhere

Acquired in-process research and development