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FOSTER CITY, Calif. - Mirum Pharmaceuticals, Inc. (NASDAQ:MIRM), a $2.27 billion market cap biotech company with impressive 81% revenue growth over the last twelve months, has announced that its partner, Takeda Pharmaceutical Company Limited, has secured approval from the Japanese Ministry of Health, Labour, and Welfare for LIVMARLI® (maralixibat) oral solution. According to InvestingPro data, the company maintains a healthy 76% gross profit margin. This medication is now the first and only approved treatment for cholestatic pruritus associated with Alagille syndrome (ALGS) and Progressive Familial Intrahepatic Cholestasis (PFIC) in Japan.
The approval of LIVMARLI in Japan marks a significant milestone for patients suffering from these rare cholestatic liver diseases. ALGS and PFIC are genetic disorders that can cause severe itching and liver damage due to bile build-up. LIVMARLI, an inhibitor of the ileal bile acid transporter (IBAT), has already been approved in over 40 countries for ALGS and over 30 countries for PFIC. Mirum’s stock has reflected this success, with InvestingPro showing an impressive 84% return over the past year. Subscribers can access 8 additional ProTips and comprehensive analysis in the Pro Research Report.
Chris Peetz, CEO of Mirum Pharmaceuticals, expressed confidence in Takeda’s ability to make a meaningful impact on the lives of patients with these conditions in Japan. The partnership between the two companies began in September 2021, when they entered into an exclusive license agreement for the development and commercialization of LIVMARLI in Japan. As part of the agreement, Mirum is set to receive a percentage of Takeda’s annual net sales.
LIVMARLI has been approved in the United States for ALGS patients three months and older and in Europe for those two months and older. Similarly, for PFIC patients, the medication is approved in the U.S. for those 12 months and older and in Europe for patients three months and older. The drug is also currently under evaluation in the Phase 3 EXPAND study for additional cholestatic pruritus conditions.
The approval of LIVMARLI in Japan is based on a press release statement from Mirum Pharmaceuticals, a company dedicated to transforming the treatment of rare diseases affecting children and adults. Mirum’s portfolio includes three approved medications and a late-stage pipeline with investigational treatments for several rare diseases. InvestingPro analysis reveals the company maintains strong financial health with a current ratio of 3.1, indicating robust liquidity to support its growth initiatives. The company’s overall financial health score is rated as "GOOD" by InvestingPro’s comprehensive evaluation system.
In other recent news, Mirum Pharmaceuticals reported fourth-quarter earnings that did not meet analyst expectations, with an adjusted loss of $1.85 per share compared to the anticipated $0.30 loss. Despite this, the company exceeded revenue expectations, generating $99.41 million, surpassing the forecasted $95.4 million and marking a 55.6% increase year-over-year. For the full year 2024, Mirum’s total net product sales reached $336.4 million, up from $178.9 million in 2023, with LIVMARLI contributing $213.3 million. Looking ahead, Mirum has provided guidance for 2025, projecting global net product sales between $420 million and $435 million and anticipating positive cash flow. H.C. Wainwright recently raised Mirum’s stock target to $72, maintaining a Buy rating, following Mirum’s announcement that it is on track to meet its 2025 sales guidance. The company is also progressing with its clinical trials, including the Phase 3 EXPAND study of LIVMARLI and the Phase 2 VISTAS study of volixibat, with significant milestones expected in the coming years. Additionally, Mirum anticipates growth in its bile acid product portfolio following FDA approval for marketing these products for specific conditions. These developments highlight Mirum’s ongoing efforts to expand its market presence and clinical pipeline.
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