Core Insights - CorMedix (CRMD) is experiencing solid improvement in earnings estimates, which may lead to continued short-term price momentum [1][2] - The rising trend in estimate revisions reflects growing analyst optimism regarding the company's earnings prospects, which is expected to positively impact its stock price [2][3] Current-Quarter Estimate Revisions - For the current quarter, CorMedix is expected to earn $0.48 per share, representing a significant increase of +1,060.0% from the previous year [6] - The Zacks Consensus Estimate for CorMedix has risen by 55.1% over the last 30 days, with three estimates moving higher and no negative revisions [6] Current-Year Estimate Revisions - For the full year, the expected earnings per share for CorMedix is $1.85, indicating a year-over-year change of +716.7% [7] - The consensus estimate has increased by 77.35% during this time frame, with three estimates moving higher and no negative revisions [7][8] Zacks Rank and Performance - CorMedix has achieved a Zacks Rank 2 (Buy) due to favorable estimate revisions, which is a strong indicator for potential investment [9] - Stocks with Zacks Rank 1 (Strong Buy) and 2 (Buy) have historically outperformed the S&P 500 [9] Bottom Line - Strong estimate revisions have led to a 7.9% increase in CorMedix's stock over the past four weeks, suggesting further upside potential [10]

Core Viewpoint - CorMedix (CRMD) shows significant upside potential with a mean price target of $20.5, indicating a 68.6% increase from the current price of $12.16 [1] Price Targets and Analyst Estimates - The mean estimate consists of six short-term price targets with a standard deviation of $2.07, suggesting variability in analyst predictions [2] - The lowest estimate of $17.00 indicates a 39.8% increase, while the highest estimate of $23.00 suggests an 89.1% increase [2] - A low standard deviation indicates strong agreement among analysts regarding the stock's price movement [9] Earnings Estimates and Analyst Agreement - Analysts have shown increasing optimism about CRMD's earnings prospects, with a positive trend in earnings estimate revisions [11] - Over the last 30 days, three estimates have been revised higher, leading to a 77.4% increase in the Zacks Consensus Estimate [12] - CRMD holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimates [13] Caution on Price Targets - Solely relying on consensus price targets for investment decisions may not be wise, as analysts' ability to set accurate targets has been questioned [3][7] - Analysts often set optimistic price targets due to business incentives, which can lead to inflated estimates [8] - While price targets should not be ignored, they should be approached with skepticism [10]

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's DefenCath is the first and only FDA-approved antimicrobial catheter lock solution in the U.S., aimed at reducing catheter-related bloodstream infections in kidney failure patients undergoing hemodialysis [1][2] - The product was launched in April 2024 for inpatient settings and in July 2024 for outpatient hemodialysis [1] - The company anticipates significant year-over-year revenue growth driven by strong market adoption of DefenCath, with total revenues for Q3 2025 estimated at $69.55 million [4] Product and Market Position - DefenCath holds a unique market position as the only FDA-approved therapy for its specific indication, with patent protection lasting until 2033 [2] - The acquisition of Melinta Therapeutics for $300 million adds seven approved therapies to CorMedix's portfolio, enhancing its presence in hospital acute care and infectious disease markets [3] - The expanded portfolio is expected to create near-term growth opportunities, particularly for Rezzayo, which is under evaluation for prophylaxis of invasive fungal infections [3] Competitive Landscape - While CorMedix currently has a first-mover advantage in the CRBSI prevention market, larger companies like Pfizer and Amphastar Pharmaceuticals pose potential competitive risks due to their established presence in the heparin market [5][6] - Pfizer's extensive resources and clinical infrastructure could allow it to quickly enter the CRBSI-specific market, challenging CorMedix's position [6] - Amphastar's vertically integrated model and manufacturing expertise further highlight the competitive risks for CorMedix if these companies decide to target the same market [7]

[Filing Information](index=1&type=section&id=Filing%20Information) This section provides essential identification and contact details for CorMedix Inc. as the registrant, along with the report's filing date [Registrant Details](index=1&type=section&id=Registrant%20Details) This section provides the core identification details for CorMedix Inc. as the registrant, including its incorporation state, commission file number, IRS employer ID, principal executive offices, and contact information, along with the report date - Registrant: **CORMEDIX INC.**, incorporated in Delaware[1](index=1&type=chunk) - Report Date: **October 20, 2025**[1](index=1&type=chunk) - Principal Executive Offices: **300 Connell Drive, Suite 4200, Berkeley Heights, New Jersey 07922**[1](index=1&type=chunk) [Securities Information](index=1&type=section&id=Securities%20Information) This section details the registrant's securities registered under Section 12(b) of the Exchange Act and clarifies its status regarding emerging growth company provisions Securities Registered Under Section 12(b) | Title of each class | Trading Symbol | Name of exchange on which registered | | :------------------ | :------------- | :----------------------------------- | | Common Stock, $0.001 Par Value | CRMD | Nasdaq Global Market | - CorMedix Inc. is **not an emerging growth company**[3](index=3&type=chunk) [Item 2.02 Results of Operations and Financial Condition](index=2&type=section&id=Item%202.02%20Results%20of%20Operations%20and%20Financial%20Condition) This item reports the preliminary financial results for the recent quarter, emphasizing their provisional nature and attachment as an exhibit [Preliminary Financial Results Announcement](index=2&type=section&id=Preliminary%20Financial%20Results%20Announcement) CorMedix Inc. announced its preliminary financial results for the quarter ended September 30, 2025, via a press release issued on October 20, 2025. These results are explicitly stated as preliminary and subject to adjustment upon completion of standard accounting procedures - CorMedix Inc. issued a press release on **October 20, 2025**, announcing preliminary financial results for the quarter ended **September 30, 2025**[4](index=4&type=chunk) - The preliminary results are **subject to adjustment** upon completion of accounting procedures[4](index=4&type=chunk) - The press release is attached as **Exhibit 99.1** and incorporated by reference, furnished under Item 2.02 and Item 9.01[4](index=4&type=chunk)[5](index=5&type=chunk) [Item 9.01 Financial Statements and Exhibits](index=2&type=section&id=Item%209.01%20Financial%20Statements%20and%20Exhibits) This item provides a comprehensive list of all financial statements and supplementary exhibits included in the filing [List of Exhibits](index=2&type=section&id=List%20of%20Exhibits) This section lists the exhibits accompanying the Form 8-K filing, which include the press release detailing preliminary financial results and the interactive data file Exhibits Filed | Exhibit No. | Description | | :------------ | :----------------------------------------------------------------------- | | 99.1 | Press Release issued by CorMedix Inc., dated October 20, 2025. | | 104 | Cover Page Interactive Data File, formatted in Inline Extensible Business Reporting Language (iXBRL). | [SIGNATURES](index=3&type=section&id=SIGNATURES) This section formally confirms the report's authorization and signing by an official representative of the registrant [Authorization and Signing](index=3&type=section&id=Authorization%20and%20Signing) This section confirms the official signing of the report by an authorized representative of CorMedix Inc., fulfilling the requirements of the Securities Exchange Act of 1934 - The report was duly signed on behalf of CorMedix Inc. pursuant to the requirements of the **Securities Exchange Act of 1934**[9](index=9&type=chunk) - Signed by **Joseph Todisco**, Chief Executive Officer, on **October 20, 2025**[10](index=10&type=chunk)[11](index=11&type=chunk)

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 (CRMD) has shown significant growth in 2025, driven by the successful uptake of its lead drug, DefenCath, which is the first FDA-approved antimicrobial catheter lock solution in the U.S. [1][9] - Despite the growth, CorMedix shares have declined by 16.4% recently, underperforming the industry and broader market [2][27] - The company has raised its sales guidance for DefenCath to $200-$215 million for 2025, up from a previous estimate of $180-$200 million [8][30] Product Performance - DefenCath generated $78.8 million in net revenues in the first half of 2025, indicating a strong commercial start [7][8] - The drug's unique market position, being the only FDA-approved therapy for a specific condition, is supported by patent protection until 2033, providing a long-term revenue generation opportunity [9][10] Acquisition Impact - CorMedix completed a $300 million acquisition of Melinta Therapeutics, adding seven marketed drugs to its portfolio, which enhances its presence in the hospital acute care and infectious disease markets [12][30] - The acquisition is expected to contribute $125 million to $135 million in revenues in 2025 and is projected to be accretive to earnings per share starting in 2026 [14][15] Market Position and Competition - CorMedix currently faces competition risks from larger companies like Pfizer and Amphastar, which have established heparin products and could enter the CRBSI prevention market [16][17][27] - The company is exploring potential label expansion for DefenCath into total parenteral nutrition (TPN), which could yield peak annual sales of $150-$200 million if approved [11] Financial Outlook - CorMedix anticipates pro forma revenues of $325-$350 million for 2025, reflecting the immediate contribution from the Melinta acquisition [14][30] - Earnings estimates for 2025 have improved from $1.22 to $1.85 per share, indicating positive market sentiment despite recent stock performance [24]

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 Inc. has completed enrollment for the Phase III ReSPECT trial, which evaluates the efficacy of REZZAYO® (rezafungin) in preventing fungal infections in adult patients undergoing allogeneic blood and marrow transplantation (BMT) [1][2] - Topline results from the ReSPECT study are expected in the second quarter of 2026, which is a significant milestone towards seeking FDA approval for REZZAYO in this indication [2][5] - The ReSPECT trial is a multicenter, randomized, double-blind study comparing once-weekly rezafungin to a standard antimicrobial regimen, with the primary endpoint being fungal-free survival at day 90 [2][3] Company Overview - CorMedix is a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases, including antifungal treatments [4] - Following the acquisition of Melinta Therapeutics in August 2025, CorMedix is expanding its portfolio to include various anti-infective products alongside REZZAYO [4][5] - REZZAYO is already approved in the U.S. for treating candidemia and invasive candidiasis, with an estimated addressable market of approximately 130,000 patients for antifungal prophylaxis, translating to a total addressable market of over $2 billion [3][4] Product Details - REZZAYO (rezafungin) is a next-generation echinocandin indicated for patients with limited treatment options for candidemia and invasive candidiasis [3][7] - The drug has orphan drug exclusivity until 2035 and patent coverage until 2038 in the U.S., enhancing its market potential [3]

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]