Business
Mirum Pharmaceuticals Reports First Quarter 2023 Financial Results and Provides Business Update
- $31.6 million total revenue, including net product sales for LIVMARLI® (maralixibat) oral solution of $29.1 million, for first quarter 2023 - Conference
About this update from Mirum Pharmaceuticals, Inc.
[{"type":"text","content":"\n- $31.6 million total revenue, including net product sales for LIVMARLI® (maralixibat) oral solution of $29.1 million, for first quarter 2023\n- Conference call to provide business updates today, May 4 at 1:30 p.m. PT/4:30 p.m. ET\n\n\n FOSTER CITY, Calif.--(BUSINESS WIRE)--\nMirum Pharmaceuticals, Inc. (Nasdaq: MIRM) today reported financial results for first quarter 2023 and provided a business update.\n\n\n“We began 2023 with significant momentum, achieving $29.1 million in net product sales for LIVMARLI,” said Chris Peetz, president and chief executive officer at Mirum. “In addition to the progress of our global LIVMARLI commercial launch, our recent U.S. label expansion for LIVMARLI in Alagille syndrome to include infants three months of age and older, regulatory submissions for LIVMARLI in PFIC in the U.S. and in Europe, and multiple upcoming pipeline milestones are driving our global leadership position in rare liver disease.”\n\n\nLIVMARLI Alagille syndrome: U.S. business on track for 50% net product sales growth in 2023\n\n\n\nFirst quarter 2023 net sales grew 167% as compared to first quarter 2022.\n\n\n\nOver 600 Alagille syndrome patients have received LIVMARLI worldwide to date.\n\n\n\nLabel expansion approved by U.S. Food and Drug Administration (FDA) to include infants three months of age and older.\n\n\n\nLIVMARLI PFIC: Applications under review by global health authorities\n\n\n\nSupplemental New Drug Application (sNDA) accepted by the FDA and assigned Prescription Drug User Fee Act (PDUFA) date of December 13, 2023.\n\n\n\nApplication for label expansion for LIVMARLI in PFIC submitted to the European Medicines Agency.\n\n\n\nPipeline: Three data catalysts expected in the second half of 2023\n\n\n\nLIVMARLI in biliary atresia on-track for top-line data in second half of 2023.\n\n\n\nVolixibat in primary sclerosing cholangitis and in primary biliary cholangitis on-track for interim analyses in the second half of 2023.\n\n\n\nCorporate & financial: Balance sheet strengthened\n\n\n\nClosed upsized offering of $316.3 million aggregate principal amount of 4.00% convertible senior notes due 2029, including exercise of the initial purchasers’ option in full in April.\n\n\n\nRepurchased 9.75% royalty obligation, removed restricted cash provision on balance sheet.\n\n\n\nTotal net product sales of LIVMARLI for the quar...