Mirum Pharmaceuticals Announces Preliminary Unaudited 2023 Net Revenue and Provides Corporate Updates

Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) today provided its preliminary and unaudited estimates for full-year 2023 revenue and net product sales, corporate updates, and full-year 2024 outlook.

“2023 was a transformative year for Mirum as we cemented our position as a leader in rare disease and dramatically advanced our operating and financial scale. We expanded our reach and impact through strong global adoption of LIVMARLI and the addition of CHOLBAM and CHENODAL,” said Chris Peetz, president and chief executive officer. “In the year ahead, we are excited about the growth prospects of all three commercial medicines, the potential label expansion opportunities for LIVMARLI and CHENODAL and key volixibat analyses in primary sclerosing cholangitis and primary biliary cholangitis.”

2023 Highlights

• Established a leading pediatric hepatology franchise with three commercial medicines
• 2023 estimated LIVMARLI net product sales of $141-143 million representing approximately 89% growth over 2022 LIVMARLI net product sales
• Total expected net product sales of $69-71 million in Q4 2023 including $41-43 million in LIVMARLI net sales and approximately $28 million in net sales from CHOLBAM and CHENODAL
• Acquired two therapies commercially available in the U.S.: CHOLBAM and CHENODAL
• Announced positive Phase 3 data from the RESTORE study evaluating CHENODAL in cerebrotendinous xanthomatosis (CTX) patients
• Expanded LIVMARLI’s US label in Alagille syndrome (ALGS) to include infants 3 months of age and older
• Grew international business to 18 countries with reimbursed access
• Company fully financed with strong balance sheet and financial performance
• Announced the appointment of Eric Bjerkholt as Chief Financial Officer

The foregoing amounts relating to 2023 financial data are unaudited and preliminary and are subject to completion of financial closing procedures. Additional information and disclosure would be required for a more complete understanding of the company’s financial position and results of operations as of December 31, 2023.

2024 Expectations and Milestones

• Expect continued revenue growth across all three commercial medicines
• U.S. Food and Drug Administration (FDA) Prescription Drug User Free Act (PDUFA) date for LIVMARLI in progressive familial intrahepatic cholestasis (PFIC) is March 13, 2024.
• New Drug Application (NDA) submission for CHENODAL in CTX planned in first half 2024
• Volixibat VISTAS study in primary sclerosing cholangitis blinded interim analysis expected first half 2024
• Volixibat VANTAGE study for primary biliary cholangitis interim analysis expected in first half 2024

Mirum will present at the 42^nd annual J.P. Morgan Healthcare Conference in San Francisco on Wednesday, January 10, 2024 at 10:30 a.m. PT. The presentation and question and answer session will be webcast live and can be accessed by visiting the Investors and Media section of Mirum’s corporate website. The replay of the webcast will be available for 30 days.