Key Takeaways CorMedix's DefenCath drives strong 2025 revenue growth and profitability after expanded U.S. market adoption.The Melinta acquisition adds seven approved drugs, expanding CorMedix's hospital and infection focus.Theravance leans on Viatris for Yupelri sales while advancing late-stage ampreloxetine for nOH MSA.In the competitive world of small-cap biotechnology, CorMedix (CRMD) and Theravance Biopharma (TBPH) stand out as two companies working to turn scientific progress into lasting profits. Bot ...

Key Takeaways CorMedix posted preliminary Q3 2025 net revenues topping $125M, with over $85M from DefenCath alone.The company raised its full-year 2025 revenue outlook to at least $375M and expects $70M in EBITDA.Melinta's integration and DefenCath's exclusivity through 2033 reinforce CRMD's growth and profitability.CorMedix (CRMD) is expected to report its third-quarter 2025 earnings results soon. The Zacks Consensus Estimate for sales and earnings is pegged at $70 million and 48 cents per share, respectiv ...

Core Insights - CorMedix (CRMD) shares increased by 19.5% to close at $12.16, following a notable trading volume compared to typical sessions, despite a previous 9.1% loss over the past four weeks [1] Financial Performance - CorMedix announced strong preliminary third-quarter 2025 results with pro forma revenue exceeding $125 million, driven by DefenCath sales over $85 million and increased utilization [2] - The company raised its full-year 2025 pro forma net revenue guidance to at least $375 million, up from the previous range of $325–$350 million, indicating stronger-than-expected growth [2] - Projected third-quarter adjusted EBITDA is $70 million, with anticipated operational synergies of $30 million from the Melinta integration [2] - The year-end cash balance is projected to be approximately $100 million, suggesting improved profitability and financial flexibility [2] Earnings Expectations - CorMedix is expected to report quarterly earnings of $0.48 per share, reflecting a year-over-year increase of 1060%, with revenues anticipated at $69.55 million, up 506.9% from the previous year [3] - The consensus EPS estimate for the quarter has been revised 55.1% higher in the last 30 days, indicating a positive trend that typically correlates with stock price appreciation [4] Industry Context - CorMedix operates within the Zacks Medical - Biomedical and Genetics industry, where another company, Legend Biotech Corporation, saw a 3% increase in its stock price, closing at $32.91, but has returned -6% over the past month [4] - Legend Biotech's consensus EPS estimate has changed by +16.7% over the past month, representing a +76.5% change from the previous year, and currently holds a Zacks Rank of 3 (Hold) [5]

Core Insights - CorMedix Inc. reported preliminary unaudited net revenue for Q3 2025 exceeding $125 million, with DefenCath contributing more than $85 million to this total [1][4] - The company has raised its full-year 2025 pro forma net revenue guidance to at least $375 million, up from the previous range of $325-$350 million [1][4] - CorMedix anticipates achieving approximately $30 million in operating synergies on a go-forward run-rate basis before the end of 2025 [1][4] Financial Performance - Preliminary Q3 2025 unaudited net revenue is reported to be over $100 million, with DefenCath revenue growth driven by higher utilization from LDO customers and other clients [4] - The company expects adjusted EBITDA for Q3 2025 to be at least $70 million [4] - As of September 30, 2025, cash, cash equivalents, and short-term investments totaled approximately $56 million, with a projected year-end balance of around $100 million [4] Business Developments - CorMedix has made significant progress in integrating the recently acquired Melinta portfolio, with expected cost synergies of $30 million before Q4 2025 and an additional $5-$15 million targeted for 2026 [4] - The company has completed enrollment in the Phase III ReSPECT study for Rezzayo, aimed at preventing fungal infections in patients undergoing allogeneic blood and marrow transplants, with clinical data expected in Q2 2026 [4][6] - The total addressable market for prophylaxis is estimated to exceed $2 billion [4] Product Portfolio - CorMedix is focused on developing and commercializing therapeutic products for life-threatening conditions, including DefenCath for preventing catheter-related bloodstream infections [5] - Following the acquisition of Melinta Therapeutics, the company is also commercializing a range of anti-infective products, including MINOCIN, REZZAYO, VABOMERE, ORBACTIV™, BAXDELA, and KIMYRSA [5]

Core Insights - CorMedix's lead drug, DefenCath, is the first FDA-approved antimicrobial catheter lock solution in the U.S., aimed at reducing catheter-related bloodstream infections in patients with kidney failure undergoing hemodialysis [1][10] - The company has launched DefenCath commercially in April 2024 for inpatient settings and in July 2024 for outpatient hemodialysis [1] Product and Market Position - DefenCath combines taurolidine and heparin, targeting a niche population of kidney failure patients [2] - CorMedix currently holds a first-mover advantage in the U.S. market for CRBSI prevention, with no direct competitors [2] - However, larger pharmaceutical companies like Pfizer and Amphastar Pharmaceuticals pose potential competitive threats due to their existing heparin products and resources [3][4] Competitive Landscape - Pfizer markets Heparin Sodium Injection, which has broad clinical applications, and could pivot to CRBSI-specific indications, challenging CorMedix's market position [3] - Amphastar's vertically integrated model and manufacturing expertise present a competitive risk if they decide to enter the CRBSI market [4] Strategic Moves - CorMedix has acquired Melinta Therapeutics for $300 million to diversify its revenue streams and reduce reliance on DefenCath [5][8] - The acquisition adds seven marketed therapies to CorMedix's portfolio, enhancing its position in hospital acute care and infectious disease markets [6][10] Financial Performance - CorMedix's stock has increased by 42.7% this year, outperforming the industry growth of 8.3% [9] - The company's shares currently trade at a price/book ratio of 4.09, higher than the industry average of 3.37, but below its five-year mean of 3.54 [11] Earnings Estimates - Earnings estimates for CorMedix have significantly improved, with 2025 estimates rising from $0.97 to $1.83 per share and 2026 estimates from $1.65 to $2.48 [14]

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]

Core Insights - CorMedix (CRMD) has acquired Melinta Therapeutics for $300 million, diversifying its revenue and reducing reliance on a single product [1][10] - The acquisition adds seven approved therapies to CorMedix's portfolio, enhancing its position in the hospital acute care and infectious disease markets [1][3] - CorMedix's lead product, DefenCath, is the first antimicrobial catheter lock solution in the U.S., but the company previously faced risks due to a lack of a broader development pipeline [2][6] Financial Outlook - CorMedix expects pro forma revenues for 2025 to be between $325 million and $350 million, with Melinta's portfolio contributing approximately $125 million to $135 million [5][10] - The acquisition is projected to be accretive to earnings per share starting in 2026, with anticipated annual cost synergies of $35 million to $45 million [5][10] - Estimates for CorMedix's 2025 earnings have improved from $1.10 to $1.52 per share, and 2026 earnings estimates have risen from $1.46 to $2.12 [15] Market Position and Competition - CorMedix currently holds a first-mover advantage in the U.S. for CRBSI prevention, but faces potential competition from larger companies like Pfizer and Amphastar Pharmaceuticals [7][8] - The acquisition of Melinta is a strategic move to mitigate risks from potential new entrants in the CRBSI treatment market [6][10] - The competitive landscape includes established players with extensive resources that could challenge CorMedix's market position if they enter the CRBSI-specific applications [7][9]