AI Earnings Predictions for Mirum Pharmaceuticals Inc. (MIRM)

EX-99.1

2 mirm-20260805xexx991.htm

EX-99.1

Document

Exhibit 99.1

Mirum Pharmaceuticals Reports Second Quarter 2026 Financial Results and Provides Business Update

–Q2 2026 net product sales of $176 million

–2026 net product sales guidance increased to $680 million to $700 million

–Volixibat granted Breakthrough Therapy and Orphan Drug Designations for cholestatic pruritus due to PSC

–Pre-NDA meeting held for volixibat in cholestatic pruritus due to PSC; additional discussions planned before potential NDA submission, now targeted in H1 2027

–Enrollment completed in VANTAGE study of volixibat in cholestatic pruritus due to PBC; data expected Q1 2027

–Conference call to provide business updates today, August 5 at 1:30 p.m. PT / 4:30 p.m. ET

FOSTER CITY, Calif. – August 5, 2026 – Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM), a leading rare disease company, today reported financial results for the second quarter 2026 and provided a business update.

“Mirum delivered another strong quarter, with continued commercial momentum supporting an increase to our full-year net product sales guidance and launch readiness for the upcoming potential approval of zilurgisertib,” said Chris Peetz, Chief Executive Officer of Mirum. “The FDA’s decision to grant volixibat Breakthrough Therapy and Orphan Drug Designations underscores the strength of the VISTAS efficacy data and the serious unmet need in PSC. VISTAS was designed with FDA input as a pivotal study and met its primary endpoint with highly significant results. However, at our recent pre-NDA meeting, the agency recommended conducting a Phase 3 study. We intend to hold further discussions with the FDA before a potential NDA submission in the first half of 2027 based on VISTAS.”

Q2 and Recent Highlights

Commercial: Raising Full Year Net Product Sales Guidance to $680 Million to $700 Million

•Second quarter 2026 global net product sales of $176.2 million.

•Second quarter 2026 LIVMARLI® net product sales were $128.7 million, representing 46% growth over second quarter 2025 net product sales.

•Second quarter 2026 Bile Acid Medicines net product sales were $47.5 million, representing 20% growth over second quarter 2025 net product sales.

Regulatory and Pipeline: Advancing Toward Multiple Milestones

•U.S. FDA granted volixibat Breakthrough Therapy Designation for the treatment of cholestatic pruritus due to primary sclerosing cholangitis (PSC) and Orphan Drug Designation for PSC.

•Participated in pre-NDA meeting with U.S. FDA for volixibat in cholestatic pruritus due to PSC; planning additional discussions with the FDA before potential NDA submission, now targeted in H1 2027.

•Brelovitug AZURE-1 and AZURE-4 Phase 3 studies in chronic hepatitis delta virus (HDV) topline results expected in Q3 and Q4 2026, respectively.

•LIVMARLI EXPAND Phase 3 study in cholestatic pruritus due to additional rare cholestatic conditions topline results expected in Q4 2026.

•Completed enrollment in the volixibat VANTAGE Phase 2b study in cholestatic pruritus due to primary biliary cholangitis (PBC); topline results expected in Q1 2027.

•Presented positive pivotal Phase 2 results from the PROGRESS study of zilurgisertib in fibrodysplasia ossificans progressiva (FOP) at ENDO 2026; Prescription Drug User Fee Act (PDUFA) target action date for the zilurgisertib NDA is September 26, 2026.

Corporate & Financial: Strong Balance Sheet and Financial Independence

•Total revenue for the quarter ended June 30, 2026 was $176.2 million compared to $127.8 million for the quarter ended June 30, 2025.

•Total operating expenses were $218.8 million for the quarter ended June 30, 2026 compared to $132.8 million for the quarter ended June 30, 2025. Total operating expenses for the quarter ended June 30, 2026 included:

◦Cost of sales of $23.2 million, excluding intangible amortization and stock-based compensation expense.

◦Non-recurring acquired in-process research and development (IPR&D) expense associated with the exclusive license of worldwide rights to zilurgisertib of $16.4 million.

◦Research and development expense of $76.3 million, including $28.8 million for the development of brelovitug, excluding stock-based compensation expense.

◦Selling, general, and administrative expense of $65.6 million, excluding stock-based compensation expense.

◦$37.3 million of stock-based compensation, intangible amortization, and other non-cash expenses.

•Issued $690.0 million aggregate principal amount of 0.00% convertible senior notes due 2032.

•Settled $237.2 million aggregate principal amount of 4.00% convertible senior notes due 2029, which represented approximately 75% of the then-outstanding notes.

•As of June 30, 2026, Mirum had unrestricted cash, cash equivalents, and investments of $561.3 million compared to $391.4 million as of December 31, 2025.

Business Update Conference Call

Mirum will host a conference call today, August 5 at 1:30 p.m. PT/4:30 p.m. ET, to provide business updates. Join

EX-99.1

2 mirm-20260506xexx991.htm

EX-99.1

Document

Exhibit 99.1

Mirum Pharmaceuticals Reports First Quarter 2026 Financial Results and Provides Business Update

–Q1 2026 net product sales of $159.9 million

–2026 net product sales guidance increased to $660 to $680 million

–Volixibat VISTAS Phase 2b study met primary endpoint

–Brelovitug Phase 2b portion of AZURE-1 study met primary endpoint

–In-licensed exclusive worldwide rights to zilurgisertib (ALK2 inhibitor) for FOP; FDA Priority Review granted with September 26, 2026 PDUFA date

–Conference call to provide business updates today, May 6 at 1:30 p.m. PT / 4:30 p.m. ET

FOSTER CITY, Calif. – May 6, 2026 - Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM), a leading rare disease company, today reported financial results for the first quarter 2026 and provided a business update.

“2026 is off to an excellent start, driven by strong commercial momentum, the recent VISTAS and AZURE-1 topline results, disciplined clinical execution, and continued expansion of our pipeline,” said Chris Peetz, Chief Executive Officer of Mirum. “We also announced today the in-license of zilurgisertib, a once-daily oral ALK2 inhibitor for fibrodysplasia ossificans progressiva from Incyte. Zilurgisertib has completed a pivotal study for FOP and its NDA has been accepted, creating the potential for an additional product launch for our rare genetic disease team later this year. We’re grateful to Incyte for all the work they have conducted on this program and look forward to potentially bringing another high impact medicine to patients.”

Q1 and Recent Highlights

Commercial: Raising Full Year Revenue Guidance to $660 to $680 Million

•First quarter 2026 global net product sales of $159.9 million.

•First quarter 2026 LIVMARLI® net product sales were $113.8 million, representing 55% growth over first quarter 2025 net product sales.

•First quarter 2026 Bile Acid Medicines net product sales were $46.1 million, representing 20% growth over first quarter 2025 net product sales.

Regulatory and Pipeline: Milestones on Track with Expansion of Leadership in Rare Disease

•Reported volixibat VISTAS Phase 2b study in primary sclerosing cholangitis (PSC) met primary endpoint; full results to be presented in a late-breaking oral presentation at the European Association for the Study of the Liver (EASL) Congress on May 30 at 2:15 p.m. CEST; U.S. NDA submission expected in H2 2026.

•Reported brelovitug Phase 2b portion of AZURE-1 study in chronic hepatitis delta virus (HDV) met primary endpoint; full results to be presented in a late-breaking poster presentation at the EASL Congress on May 27 starting at 8:30 a.m. CEST.

•Completed enrollment in brelovitug AZURE-1 and AZURE-4 Phase 3 studies in HDV; topline results expected in H2 2026.

•Completed enrollment in LIVMARLI (maralixibat) EXPAND Phase 3 study in additional rare cholestatic conditions; topline results expected in Q4 2026.

•VANTAGE study in primary biliary cholangitis (PBC) topline results now expected in Q1 2027.

Business Development: Obtained Exclusive Worldwide Rights to Zilurgisertib

•Entered into an exclusive license agreement with Incyte for worldwide rights to zilurgisertib, an ALK2 inhibitor in development for fibrodysplasia ossificans progressiva (FOP).

•U.S. FDA accepted the New Drug Application (NDA) for zilurgisertib in FOP patients 12 years and older and granted Priority Review with a Prescription Drug User Fee Act (PDUFA) date of September 26, 2026.

•Results from the pivotal Phase 2 PROGRESS study in FOP formed the basis of the NDA filing for zilurgisertib; Incyte plans to present the results at an upcoming medical conference.

•In return for the exclusive license of worldwide rights to zilurgisertib, Incyte received an upfront payment of $16 million and is eligible to receive additional development and regulatory milestone payments, as well as sales-based milestones and tiered royalties on worldwide net sales in the mid-to-high single digit percent range.

Corporate & Financial: Strong Balance Sheet and Financial Independence

•Total revenue for the quarter ended March 31, 2026 was $159.9 million compared to $111.6 million for the quarter ended March 31, 2025.

•Total operating expenses were $949.3 million for the quarter ended March 31, 2026 compared to $126.8 million for the quarter ended March 31, 2025. Total operating expenses for the quarter ended March 31, 2026 included:

◦Cost of sales of $22.1 million, net of intangible amortization.

◦Non-recurring in-process research and development (IPR&D) expense associated with the acquisition of Bluejay Therapeutics of $726.3 million.

◦$63.8 million of stock-based compensation, intangible amortization, and other non-cash expenses, including $34.7 million of non-recurring stock-based compensation expense associated with the acquisition of Bluejay Therapeutics.

◦Research and development expense of $73.7 million, including $20.8 million for the development of brelovit

mirm-20260225false000175942500017594252026-02-252026-02-25

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): February 25, 2026

Mirum Pharmaceuticals, Inc. (Exact name of Registrant as Specified in Its Charter)

Delaware001-3898183-1281555 (State or Other Jurisdiction of Incorporation) (Commission File Number)(IRS Employer Identification No.)

989 East Hillsdale Boulevard Suite 300

Foster City, California 94404 (Address of Principal Executive Offices)(Zip Code)

Registrant’s Telephone Number, Including Area Code: (650) 667-4085 N/A (Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions: o   Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) o   Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) o   Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) o   Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) Securities registered pursuant to Section 12(b) of the Act:

Title of each classTrading Symbol(s) Name of each exchange on which registered Common stock, par value $0.0001 per shareMIRM

Nasdaq Global Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter). Emerging growth company ☐ If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 2.02 Results of Operations and Financial Condition. On February 25, 2026, Mirum Pharmaceuticals, Inc. (the “Company”) issued a press release providing a corporate update and announcing its financial results for the quarter and year ended December 31, 2025. The full text of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference. The information in this Current Report on Form 8-K (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, nor shall it be deemed to be incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.

Item 9.01 Financial Statements and Exhibits. (d)Exhibits.

Exhibit No. Description

99.1 Press Release dated February 25, 2026

104Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

Mirum Pharmaceuticals, Inc.

Date: February 25, 2026 By:/s/ Christopher Peetz Christopher Peetz Chief Executive Officer