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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]
Mirum Pharmaceuticals (NasdaqGM:MIRM) FY Conference Transcript
2025-09-10 15:02
Summary of Mirum Pharmaceuticals FY Conference Call Company Overview - **Company**: Mirum Pharmaceuticals (NasdaqGM:MIRM) - **Industry**: Biopharmaceuticals focused on rare diseases - **Products**: Three commercialized small molecule drugs: LIVMARLI, CHOLBAM, and CHENODAL [1][2] Financial Performance - **Revenue Guidance**: Management raised revenue guidance for 2025 to a range of $490 million to $510 million, reflecting robust revenue gains in the first half of 2025 compared to 2024 [1][2] - **Cash Flow**: The company is operating cash flow positive and has a strong balance sheet [2] Product Details LIVMARLI - **Indications**: Approved for Alagille syndrome and PFIC (Progressive Familial Intrahepatic Cholestasis) [3] - **Market Growth**: The PFIC indication has shown unexpected growth, particularly in adult populations, leading to increased patient identification [4][5] - **Clinical Profile**: LIVMARLI has a differentiated clinical profile, showing benefits in pruritus, growth, and bilirubin improvements [4] CHENODAL - **Indication**: Approved for CTX (Cerebrotendinous Xanthomatosis) with seven years of orphan exclusivity [3] CHOLBAM - **Indication**: Approved for bile acid synthesis disorders [3] International Expansion - **Partnerships**: Strong performance from international business, particularly in Japan with partner Takeda, who received approvals for Alagille and PFIC [6] Clinical Pipeline EXPAND Trial - **Objective**: Expanding the label of LIVMARLI to include additional settings of cholestatic pruritus, targeting at least 500 pediatric patients in the U.S. [7][8] VISTA Study - **Indication**: Evaluating volixibat for PSC (Primary Sclerosing Cholangitis) with an expected top-line readout in Q2 of the following year [9][10] - **Market Size**: Approximately 30,000 patients in the U.S., with a significant unmet need for effective treatments [9][10] AVANTAGE Study - **Indication**: Evaluating volixibat for PBC (Primary Biliary Cholangitis) with positive interim data showing significant improvements in pruritus and fatigue [17][18] MRM-3379 - **Indication**: Targeting Fragile X syndrome, a genetic mutation leading to autism spectrum disorder, with a market opportunity of around 25,000 patients in the U.S. [22][23] - **Phase 2 Study**: Expected to start in Q4 of the current year, focusing on different age groups [25] Competitive Landscape - **Volixibat Positioning**: Positioned as a first-line treatment option for pruritus in PBC, differentiating from existing therapies that primarily target second-line settings [20][21] Future Outlook - **Clinical and Commercial Catalysts**: Continued growth of all three medicines, initiation of Phase 2 in Fragile X, and upcoming data readouts for PSC and PBC expected in 2026 [27] - **Portfolio Expansion**: The company is actively looking for opportunities in the rare disease space, focusing on adding value and ensuring alignment with current capabilities [28][29]
MIRM Stock Up on Q2 Earnings and Revenue Beat, Raised 2025 View
ZACKS· 2025-08-07 16:20
Core Insights - Mirum Pharmaceuticals reported a narrower loss of $0.12 per share for Q2 2025, compared to a loss of $0.52 per share in the same quarter last year, and better than the Zacks Consensus Estimate of a loss of $0.31 per share [1][8] - Revenues for Q2 2025 reached $127.8 million, reflecting a year-over-year increase of 64.1%, surpassing the Zacks Consensus Estimate of $108 million, driven by strong sales of Livmarli and newly acquired bile acid products [2][8] - The company raised its revenue guidance for 2025 to a range of $490 million to $510 million, up from the previous estimate of $435 million to $450 million, due to the strong performance of Livmarli [10] Financial Performance - Livmarli's net product sales were $88.2 million in Q2 2025, marking an 87% increase year-over-year, with U.S. sales at $57 million and ex-U.S. sales at $31.2 million [7][8] - Net product sales from bile acid products, including Cholbam and Ctexli, totaled $39.6 million in Q2 2025, reflecting a 30% year-over-year increase [7] - Research and development expenses rose by nearly 41% year-over-year to $46.1 million, while selling, general, and administrative expenses increased by approximately 28.7% to $63.3 million [9] Recent Developments - Mirum is conducting a phase III EXPAND study for Livmarli to treat pruritus in rare cholestatic conditions, with enrollment expected to complete in 2026 [11] - The FDA approved a new tablet formulation of Livmarli, launched in the U.S. in June 2025, aimed at improving convenience for older patients [11] - The lead pipeline candidate, volixibat, is under evaluation in two phase IIb studies for primary biliary cholangitis and primary sclerosing cholangitis, with top-line data expected in Q2 2026 [12] Stock Performance - Mirum's shares increased by 8.6% in after-hours trading on August 6, 2025, following the better-than-expected results and raised revenue guidance [4] - Year-to-date, Mirum's stock has risen by 29.1%, significantly outperforming the industry average increase of 0.2% [6]
FDA Accepts GSK's NDA for Linerixibat in Rare Disease-Related Itch
ZACKS· 2025-06-03 16:46
Core Insights - GSK's new drug application for linerixibat has been accepted by the FDA for review, with a decision expected on March 24, 2026 [1][7] - If approved, linerixibat could fulfill a significant unmet medical need for patients suffering from cholestatic pruritus associated with primary biliary cholangitis (PBC) [2][5] GSK's Drug Development - The NDA for linerixibat is based on positive results from the phase III GLISTEN study, which demonstrated significant improvement in cholestatic pruritus and related sleep interference compared to placebo [4][7] - Cholestatic pruritus is a common symptom of PBC, a rare autoimmune disease that can lead to liver failure [5] Competitive Landscape - Other companies are also pursuing treatments for PBC, including Gilead Sciences, which received accelerated approval for seladelpar in August 2024 [8] - Seladelpar was acquired by Gilead for $4.3 billion and is now part of their liver disease portfolio [9] - Mirum Pharmaceuticals is developing volixibat, another oral IBAT inhibitor, currently in phase IIb trials [9]
Mirum's Q1 Earnings Beat Estimates, 2025 Revenue View Raised
ZACKS· 2025-05-08 17:16
Core Insights - Mirum Pharmaceuticals reported a narrower loss of 30 cents per share in Q1 2025, compared to a loss of 54 cents per share in the same quarter last year, and better than the Zacks Consensus Estimate of a loss of 39 cents [1][2] - The company's revenues for Q1 2025 reached $111.6 million, reflecting a year-over-year increase of nearly 62%, surpassing the Zacks Consensus Estimate of $98 million [2][3] Financial Performance - Livmarli's net product sales were $73.2 million in Q1 2025, marking a 71% increase year over year, with U.S. sales at $49.5 million and ex-U.S. sales at $23.7 million [6] - Net product sales from bile acid products, including Cholbam and Ctexli, totaled $38.4 million in Q1 2025, up 47% year over year [7] - Research and development expenses rose by 42.8% year over year to $46 million, while selling, general, and administrative expenses increased by 26.5% to $57.7 million [7][8] Guidance and Future Outlook - Mirum raised its full-year revenue guidance for 2025 to a range of $435-$450 million, up from the previous estimate of $420-$435 million, due to strong demand for its commercial products [9] - The company is evaluating Livmarli in a phase III study for treating pruritus in rare cholestatic conditions, with enrollment expected to complete in 2026 [10] Recent Developments - The FDA approved a new tablet formulation of Livmarli for treating cholestatic pruritus in patients with Alagille syndrome and progressive familial intrahepatic cholestasis [10] - Ctexli tablets received FDA approval for treating adults with cerebrotendinous xanthomatosis, becoming the first approved treatment for this condition [11] - Mirum's lead pipeline candidate, volixibat, is in two phase IIb studies for primary biliary cholangitis and primary sclerosing cholangitis, with enrollment expected to complete in 2026 [11][12]
MIRM's Q4 Loss Wider Than Expected, Revenues Beat Estimates
ZACKS· 2025-02-27 16:25
Core Insights - Mirum Pharmaceuticals reported a wider loss of 49 cents per share in Q4 2024, compared to the Zacks Consensus Estimate of a loss of 27 cents, and a loss of 66 cents per share in the same quarter last year [1] - The company's revenues for Q4 totaled $99.4 million, reflecting a year-over-year increase of 42.8%, surpassing the Zacks Consensus Estimate of $97 million [2] - Mirum's stock has increased by 70.3% over the past year, while the industry has declined by 9.5% [3] Financial Performance - Research and development expenses rose by 42.4% year-over-year to $44 million, while selling, general, and administrative expenses increased by 22.9% to $56.8 million [4] - As of December 31, 2024, the company had cash, cash equivalents, and marketable securities totaling $292.8 million, slightly down from $293.8 million as of September 30, 2024 [5] - For the full year 2024, Mirum generated revenues of $336.9 million, up from $186.4 million in the previous year, and reported a loss of $1.85 per share, an improvement from a loss of $4.00 per share in the prior year [8] Future Outlook - Mirum anticipates worldwide net product sales of approximately $420-$435 million and expects to achieve positive cash flow in 2025 [9] - The company is conducting a phase III study for Livmarli and has received FDA approval for Ctexli, the first treatment for cerebrotendinous xanthomatosis [10] - Mirum's lead pipeline candidate, volixibat, is under evaluation in two phase IIb studies, with enrollment expected to be completed in 2026 [11] - A phase II study for the PDE4D inhibitor, MRM-3379, is planned for Fragile X syndrome later in 2025 [12]