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Shares of Mirum Pharmaceuticals MIRM were up 12.1% this week, driven by investor enthusiasm after the company announced encouraging preliminary sales numbers for the fourth quarter and full year 2024, along with an encouraging outlook and growth strategy for 2025.
Mirum’s commercial portfolio comprises of lead product, Livmarli (maralixibat), which is approved for treating cholestatic pruritus in patients with Alagille syndrome worldwide. The drug is also approved for treating certain patients with progressive familial intrahepatic cholestasis in the United States and Europe.
MIRM acquired Travere Therapeutics’ bile acid products in August 2023, which added the latter’s Cholbam capsules and Chenodal tablets to its portfolio of commercialized drugs.
In the past year, shares of Mirum have rallied 73.3% against the industry’s decline of 16%.
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MIRM's Preliminary Results for 2024
The company reported preliminary net product sales of approximately $336 million in 2024, which surpassed the upper end of the guided range of $330-$335 million, provided with the third-quarter 2024 earnings release in November.
The company expects preliminary net product sales of Livmarli to be around $64 million in the fourth quarter and $213 million for full-year 2024.
Preliminary net product sales from Cholbam and Chenodal are expected to be around $35 million in the fourth quarter and $123 million for full-year 2024.
Cholbam is approved for treating bile acid synthesis disorders and Zellweger spectrum disorders.
Mirum’s cash, cash equivalents and investments were around $287 million as of Dec. 31, 2024. The company achieved positive cash flow from operations in the third quarter of 2024.
MIRM's 2025 Guidance & Business Goals
The company anticipates net product sales of around $420-$435 million for full-year 2025.
Mirum is evaluating Livmarli in the phase III EXPAND study for treating pruritus in rare cholestatic conditions. Enrollment in the study is expected to be completed in 2026.
Meanwhile, a new drug application seeking approval for Chenodiol for cerebrotendinous xanthomatosis (“CTX”) patients is currently under review in the United States. A decision from the FDA is now expected on March 28, 2025.
Chenodiol is not currently approved but has received a medical necessity medicine status from the FDA for treating CTX.
Mirum’s lead pipeline candidate, volixibat, is currently being evaluated in two phase IIb studies for treating patients with primary biliary cholangitis (the VANTAGE study) and primary sclerosing cholangitis (the VISTAS study).