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Will Livmarli Continue to Drive Mirum's Top Line in Q3 Earnings?
ZACKS· 2025-10-14 16:01
Core Insights - Mirum Pharmaceuticals' lead product, Livmarli, is the primary revenue driver for the company, significantly contributing to its top-line growth [1][3][13] Product Overview - Livmarli is an orally administered ileal bile acid transporter (IBAT) inhibitor approved for treating cholestatic pruritus in patients with Alagille syndrome (ALGS) and certain patients with progressive familial intrahepatic cholestasis (PFIC) [2] - A new tablet formulation of Livmarli was approved by the FDA earlier this year, enhancing convenience for older patients [3] Financial Performance - In the first half of 2025, Livmarli's net product sales reached $161.4 million, reflecting a 79.1% year-over-year increase [3] - Mirum has raised its revenue guidance for 2025 to a range of $490-$510 million, up from the previous estimate of $435-$450 million, due to strong sales performance [6][13] Market Dynamics - Mirum's acquisition of Travere Therapeutics' bile acid products in 2023 has diversified its revenue stream, adding Cholbam capsules and Ctexli tablets to its portfolio [5] - Competition is intensifying in the market, particularly from Albireo AB's Bylvay, which directly competes with Livmarli [8] Pipeline Developments - Mirum's lead pipeline candidate, volixibat, is currently undergoing evaluation in two phase IIb studies for primary biliary cholangitis and primary sclerosing cholangitis [9] Valuation and Stock Performance - Year-to-date, Mirum's shares have increased by 74.6%, outperforming the industry average of 7.4% [14] - The company's shares are trading at a premium, with a price/book ratio of 14.21 compared to the industry average of 3.35 [15] - The Zacks Consensus Estimate for 2025 loss per share has improved from 84 cents to 69 cents, with 2026 estimates shifting from a loss of 13 cents to earnings of 3 cents [16]
CRMD vs. MIRM: Which Specialized Biotech Stock is the Better Pick?
ZACKS· 2025-09-23 15:45
Core Insights - CorMedix (CRMD) and Mirum Pharmaceuticals (MIRM) are focusing on treatments for underserved medical conditions, creating niches in areas often overlooked by larger pharmaceutical companies [1] CorMedix (CRMD) - CorMedix's lead product, DefenCath, is the first FDA-approved antimicrobial catheter lock solution in the U.S., aimed at reducing catheter-related bloodstream infections in adult patients undergoing chronic hemodialysis [2] - DefenCath generated $78.8 million in net revenues in the first half of 2025, prompting CorMedix to raise its full-year revenue guidance for 2025 [6] - The company plans to expand DefenCath's label into total parenteral nutrition to increase its customer base [7] - CorMedix acquired Melinta Therapeutics for $300 million, adding seven marketed therapies and diversifying its revenue streams [8] - The acquisition of Melinta is a strategic move to mitigate competition in the CRBSI market from established players like Pfizer and Amphastar [10] - The Zacks Consensus Estimate for CorMedix's 2025 sales and EPS indicates a year-over-year increase of approximately 411% and 607%, respectively [19] Mirum Pharmaceuticals (MIRM) - Mirum's lead product, Livmarli, is approved for treating cholestatic pruritus in patients with Alagille syndrome and has generated $161.4 million in net product sales in the first half of 2025, reflecting a 79.1% year-over-year increase [3][14] - Livmarli's sales momentum is expected to continue, supported by a new tablet formulation launched in June 2025 [13] - MIRM's revenue is heavily reliant on Livmarli, making it vulnerable to regulatory setbacks and competitive pressures, particularly from Albireo's Bylvay [18][29] - Mirum's strategic acquisition of Travere Therapeutics' bile acid products has diversified its revenue stream, generating $78 million in the first half of 2025 [17] - The Zacks Consensus Estimate for Mirum's 2025 sales implies a year-over-year increase of around 51%, with a projected 61% narrowing of loss per share [19] Comparative Analysis - Year-to-date, CRMD shares have gained 39.1%, while MIRM shares have increased by 78.7%, compared to a 3.5% return for the industry [24] - MIRM's shares trade at a higher price/book (P/B) ratio of 14.35 compared to CRMD's 3.47, indicating a more expensive valuation [25] - CorMedix is viewed as a stronger investment option due to its expanding product portfolio and growth trajectory, while Mirum's reliance on Livmarli poses risks [27][31]
Ipsen delivers strong sales in the first quarter 2025 and confirms its full-year guidance
Globenewswire· 2025-04-16 04:57
Core Insights - Ipsen reported strong sales growth for Q1 2025, with total sales reaching €918.8 million, reflecting an increase of 11.7% as reported and 11.6% at constant exchange rates (CER) [2][7] - The company highlighted significant growth in its Rare Disease segment, which saw a remarkable increase of 78.4% in sales, driven by innovative medicines [2][7] - Ipsen confirmed its full-year financial guidance for 2025, acknowledging potential negative impacts on Somatuline sales due to increased generic competition [3][7] Sales Performance - Oncology sales amounted to €655.0 million, up 8.5% [2] - Neuroscience sales reached €193.5 million, reflecting an 8.0% increase [2] - Rare Disease sales were €70.3 million, marking a substantial growth of 78.4% [2] Strategic Initiatives - The CEO emphasized the ongoing transformation of the company and the importance of 2025 for Ipsen, with multiple product launches and milestones expected [2] - Ipsen is advancing its pipeline with the regulatory filing for tovorafenib accepted by EMA for pediatric low-grade glioma, indicating a commitment to innovation in challenging cancer treatments [4][5] Financial Guidance - Ipsen confirmed its financial guidance for 2025, which includes anticipated challenges from generic competition affecting Somatuline sales [3] - The company expects total sales growth to exceed 5.0% at constant currency, with a core operating margin greater than 30.0% [8] Upcoming Milestones - Key milestones anticipated in 2025 include regulatory decisions for Cabometyx and fidrisertib, as well as proof-of-concept data for LANT [9] - The company initiated Phase I trials for IPN01195, a RAF inhibitor, complementing its existing pipeline [5] Refinancing Activities - Ipsen successfully completed its inaugural Rated Public Bond of €500 million with a coupon of 3.875%, which is part of its refinancing strategy [10]