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Mirum Pharmaceuticals MIRM incurred a loss of 30 cents per share in the first quarter of 2025, narrower than the Zacks Consensus Estimate of a loss of 39 cents. The company had reported a loss of 54 cents per share in the year-ago quarter.
Revenues in the first quarter totaled $111.6 million, up almost 62% year over year. The figure also beat the Zacks Consensus Estimate of $98 million. The top line was driven by strong growth of its marketed products, Livmarli (maralixibat) and recently acquired products, Cholbam and Ctexli (chenodiol). (Find the latest EPS estimates and surprises on Zacks Earnings Calendar.)
Livmarli 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.
Mirum acquired Travere Therapeutics’ bile acid products in August 2023, which added the latter’s Cholbam capsules and Ctexli tablets to its portfolio of commercialized drugs.
Shares of Mirum were up 3.4% in after-hours trading on May 7 following the better-than-expected earnings result announcement.
Year to date, the stock has lost 0.3% compared with the industry’s decline of 7.9%.
Livmarli’s net product sales were $73.2 million in the first quarter, reflecting an increase of 71% year over year. Livmarli sales in the United States were $49.5 million, driven by robust new patient demand across all indications. In ex-U.S. markets, Livmarli sales were $23.7 million.
Net product sales of bile acid products, comprising Cholbam and Ctexli tablets, were $38.4 million in the first quarter, reflecting an increase of 47% year over year.
The company did not record any license and other revenues in the first quarter.
Research and development expenses increased 42.8% year over year to $46 million.
Selling, general and administrative expenses totaled $57.7 million, up almost 26.5% from the year-ago quarter’s level.
As of March 31, 2025, Mirum had cash, cash equivalents and investments worth $298.6 million compared with $292.8 million as of Dec 31, 2024.
Owing to the strong demand for its commercial products, Mirum raised its full-year revenue guidance for 2025.
The company now expects revenues to be in the range of $435-$450 million in 2025, compared with the earlier projection of $420-$435 million.
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.
Last month, the FDA approved a new tablet formulation of Livmarli for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) and progressive familial intrahepatic cholestasis (PFIC). The approval for oral tablets is likely to offer convenience for the older patients.
Meanwhile, the FDA approved Ctexli tablets, a bile acid, for the treatment of adults with cerebrotendinous xanthomatosis (CTX) in February. Following the nod, Ctexli became the first and only treatment to be approved for this rare, progressive and debilitating disease.
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).
Enrollment in the VISTAS study is expected to be completed in the third quarter of 2025, with top-line data expected to be announced in the second quarter of 2026. The company expects to complete enrollment in the VANTAGE study in 2026.
Mirum also plans to initiate a phase II study on its recently in-licensed PDE4D inhibitor, MRM-3379, for treating Fragile X syndrome later in 2025.
Mirum Pharmaceuticals, Inc. price-consensus-eps-surprise-chart | Mirum Pharmaceuticals, Inc. Quote
Mirum currently carries a Zacks Rank #2 (Buy).
Some other top-ranked stocks in the biotech sector are ANI Pharmaceuticals, Inc. ANIP, Intellia Therapeutics, Inc. NTLA and Beam Therapeutics Inc. BEAM, each carrying a Zacks Rank #2 at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 60 days, estimates for ANI Pharmaceuticals’ earnings per share have increased from $6.30 to $6.36 for 2025. During the same time, earnings per share estimates for 2026 have increased from $6.85 to $7.14. Year to date, shares of ANIP have rallied 28.2%.
ANIP’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 17.32%.
In the past 60 days, estimates for Intellia Therapeutics’ loss per share have narrowed from $4.75 to $4.62 for 2025. During the same time, loss per share estimates for 2026 have narrowed from $4.68 to $4.62. Year to date, shares of NTLA have plunged 37.4%.
NTLA’s earnings beat estimates in three of the trailing four quarters while missing the same on the remaining occasion, the average surprise being 5.37%.
In the past 60 days, estimates for Beam Therapeutics’ loss per share have narrowed from $4.45 to $4.27 for 2025. During the same time, loss per share estimates for 2026 have narrowed from $4.94 to $4.80. Year to date, shares of BEAM have plunged 34.6%.
BEAM’s earnings beat estimates in two of the trailing four quarters while missing the same on the remaining two occasions, the average negative surprise being 3.14%.
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This article originally published on Zacks Investment Research (zacks.com).
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