Core Insights - CorMedix Therapeutics will host an in-person and virtual analyst day on February 10, 2026, to discuss its portfolio and pipeline, highlighting key growth drivers and upcoming milestones [1][2] Company Overview - CorMedix is a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases [4] - The company is commercializing DefenCath® for the prevention of catheter-related bloodstream infections and has a portfolio of anti-infective products following its acquisition of Melinta Therapeutics [4] Product Pipeline - CorMedix's REZZAYO® program is in Phase III for the prophylaxis of fungal infections, while DefenCath® is in Phase III for reducing CLABSI in adult patients receiving Total Parenteral Nutrition [2][5] - Topline results for the Phase III study of REZZAYO are expected in Q2 2026 [5] Event Details - The analyst day will feature key opinion leaders and senior management discussing market dynamics and unmet medical needs [2] - A live question-and-answer session will follow the presentations, with in-person attendance limited to analysts and institutional investors [3]

Core Insights - CorMedix's lead product, DefenCath, is the first and only FDA-approved antimicrobial catheter lock solution in the U.S., launched in 2024, primarily targeting catheter-related bloodstream infections in kidney failure patients undergoing hemodialysis [1][2] - DefenCath generated $167.6 million in net sales in the first nine months of 2025, with a unique market position supported by patent protection until 2033 [2][3] - CorMedix's acquisition of Melinta Therapeutics for $300 million aims to diversify revenue streams and enhance its presence in hospital acute care and infectious disease markets [3] Financial Performance - Preliminary unaudited pro forma net revenues for CorMedix in 2025 are approximately $400 million, aligning with the company's guidance of $390 million to $410 million [3] - For 2026, CorMedix has provided revenue guidance of $300-$320 million, with DefenCath expected to contribute $150-$170 million [4][10] - Adjusted EBITDA for 2026 is projected to be between $100 million and $125 million [5] Market Dynamics - DefenCath's sales are expected to be stronger in the first half of 2026, but ongoing pricing pressure and flat usage among existing customers may hinder growth [5][10] - Competition from major players like Pfizer and Amphastar Pharmaceuticals poses a risk, as they could leverage their resources to enter the catheter-related infection prevention market [6][9][11] Stock Performance and Valuation - CorMedix's stock has decreased by 36.1% over the past six months, underperforming the industry growth of 18.7% [12] - The company's shares are trading at a price/book ratio of 1.57, below the industry average of 3.58, indicating a discount in valuation [13] - Earnings estimates for 2025 have decreased from $2.87 to $2.82 per share, while 2026 estimates have dropped from $2.88 to $1.78 [14]

Core Insights - CorMedix (CRMD) and Mirum Pharmaceuticals (MIRM) attract investors in the rare-disease biotech sector due to smaller patient populations that can yield significant revenue through premium pricing and regulatory incentives [1] - Both companies benefit from clearer clinical endpoints and faster regulatory pathways, allowing quicker market entry compared to traditional drugs [1] CorMedix (CRMD) Overview - CorMedix's lead product, DefenCath, received FDA approval in late 2023 as the first antimicrobial catheter lock solution in the U.S., aimed at reducing catheter-related bloodstream infections in kidney failure patients [2] - DefenCath generated $167.6 million in net sales in the first nine months of 2025, indicating strong market adoption [7] - The company plans to expand DefenCath's label into total parenteral nutrition and has diversified its revenue through a $300 million acquisition of Melinta Therapeutics, adding seven approved therapies to its portfolio [7] - Despite initial success, CorMedix's future outlook is cautious, with 2026 revenue guidance of $300-$320 million and projected 2027 revenues of $100-$140 million, reflecting pricing pressures and limited growth [8][11] Mirum Pharmaceuticals (MIRM) Overview - Mirum's lead product, Livmarli, is approved for treating cholestatic pruritus in patients with Alagille syndrome and has seen a 70% year-over-year increase in net sales, reaching $161.4 million in the first nine months of 2025 [3][12] - The company has expanded its portfolio with a new tablet formulation of Livmarli and additional bile acid products from the acquisition of Travere Therapeutics, generating $118.8 million in the first nine months of 2025 [16] - MIRM's revenue guidance for 2026 is approximately $630-$650 million, supported by a broader product base and ongoing clinical studies for new therapies [16][28] Comparative Analysis - Both companies exhibit a similar risk-reward profile, but MIRM presents a clearer growth narrative with multiple revenue drivers, while CRMD's outlook is clouded by conservative guidance and reliance on a single product [4][9] - MIRM's shares have increased by 75.3% over the past six months, contrasting with CRMD's 38% decline, indicating market preference for MIRM's growth potential [23] - Valuation metrics show MIRM trading at a price/book ratio of 16.02, significantly higher than CRMD's 1.43, reflecting investor confidence in MIRM's growth prospects [24] Investment Recommendation - Mirum Pharmaceuticals is viewed as the better investment opportunity due to its strong sales growth, diversified revenue streams, and multiple growth levers, while CorMedix faces more uncertainty and competitive pressures [25][29]

Core Insights - CorMedix's lead product, DefenCath, is the first and only FDA-approved antimicrobial catheter lock solution in the U.S., aimed at reducing catheter-related bloodstream infections (CRBSIs) in adult patients undergoing chronic hemodialysis [1][10] - DefenCath was launched in 2024 and is protected by patents until 2033, with plans for label expansion into total parenteral nutrition [2] - The company reported preliminary revenues of approximately $127 million for Q4 2025 and $310 million for the full year, with adjusted EBITDA expected between $77-$81 million for Q4 2025 [4][6] Product and Market Position - DefenCath's unique market position as the only FDA-approved therapy for a niche condition supports its revenue growth, with expectations of it being a key driver in Q4 2025 [2][10] - CorMedix's acquisition of Melinta Therapeutics for $300 million has diversified its revenue streams and strengthened its presence in hospital acute care and infectious disease markets, contributing $12.8 million in revenues in Q3 2025 [3] Financial Performance - Pro forma net revenues for full-year 2025 were around $400 million, with cash and short-term investments reported at approximately $148 million as of December 31, 2025, indicating improved financial flexibility [5] - For 2026, total revenue expectations are between $300-$320 million, with DefenCath projected to contribute $150-$170 million [6] Competitive Landscape - CorMedix faces strong competition from established players in the heparin market, such as Pfizer and Amphastar Pharmaceuticals, which could pose risks to its market advantage [7][9] - Major competitors have the potential to enter the CRBSI prevention market, which could challenge CorMedix's growth outlook [8][12] Stock Performance and Valuation - CorMedix's stock has declined by 36.3% over the past six months, underperforming the industry growth of 21.1% [13] - The company's shares are trading at a price/book ratio of 1.49, lower than the industry average of 3.56, indicating a discount in valuation [14] - Earnings estimates for 2025 have increased from $2.57 to $2.85 per share, while estimates for 2026 have decreased from $2.72 to $2.37 [17]

Core Viewpoint - CorMedix Inc. is under investigation for potential violations of federal securities laws following a significant revenue guidance reduction due to changes in reimbursement policy for its product DefenCath [1][2]. Financial Performance - CorMedix announced preliminary fourth quarter and full year 2025 results, revealing a revenue guidance cut from $400 million to a range of $300 million to $320 million [2]. - The anticipated reimbursement policy change for DefenCath is expected to significantly reduce institutional reimbursement levels and net pricing in the second half of 2026 [2]. Market Reaction - Following the announcement of the revenue guidance reduction, CorMedix's stock price fell over 21%, opening at $8.73 per share [2].

Company Overview - CorMedix Therapeutics is a diversified specialty pharmaceutical company focused on institutional settings of care, primarily offering injectable drugs used in hospitals and infusion centers [3] - The company has a strong financial profile with approximately $150 million in cash and close to zero net debt [3] Financial Projections - Revenue guidance for 2026 is projected to exceed $300 million, with EBITDA expected to be between $100 million and $125 million [3] - The company anticipates increasing its cash position throughout the year [3] Commercial Strategy - CorMedix has a scalable platform supported by a solid commercial team experienced across multiple therapeutic areas [4]

CorMedix FY Conference Summary Company Overview - **Company**: CorMedix (NasdaqGM:CRMD) - **Industry**: Specialty Pharmaceuticals - **Focus**: Institutional settings of care, primarily injectable drugs used in hospitals and infusion centers [2][3] Financial Highlights - **Cash Position**: Approximately $150 million cash on hand, close to zero net debt [2][6] - **Revenue Guidance for 2026**: Expected to exceed $300 million, with EBITDA between $100-$125 million [3][5] - **2025 Revenue**: Exceeded $400 million, driven by DefendCath and Melinta acquisition [5][6] Key Products and Pipeline DefendCath - **Approval**: Approved in late 2023, launched mid-2024 [6][8] - **Indication**: Reduces risk of catheter-related bloodstream infections (CRBSIs) in hemodialysis patients [8][9] - **Market Size**: Total addressable market (TAM) of approximately $750 million [23] - **Reimbursement**: Under CMS's TDAPA, transitioning to post-TDAPA add-on period in July 2026 [10][11] - **Clinical Impact**: Phase 3 study showed a 71% reduction in CRBSI risk; real-world data from US Renal Care showed a 70% reduction in hospitalizations [12][13] Rezzayo - **Current Status**: In phase three clinical studies for prophylaxis of fungal infections in immunocompromised patients, with results expected in Q2 2026 [3][14] - **Market Potential**: TAM over $2 billion for prophylaxis of invasive fungal infections [21] Leadership and Team - **New Additions**: Mike Seckler as Chief Commercial Officer and Susan Blum as CFO, enhancing the leadership team [4] Strategic Initiatives - **Acquisition of Melinta**: Added $140 million in revenue and a portfolio of anti-infectious products [5][16] - **Future Growth**: Focus on expanding indications for existing products and pursuing strategic tuck-in business development [17][23] Market Position and Valuation - **Current Valuation**: Trading at a significant discount compared to peers (5x EBITDA vs. 12x for peers) [27] - **Investor Education**: Emphasis on improving communication regarding the value of Rezzayo and DefendCath for TPN [27][28] Upcoming Milestones - **Analyst Day**: Scheduled for February 10, 2026, to discuss growth trajectory and upcoming catalysts [24] - **Clinical Data Updates**: Expected for TPN study and Rezzayo sNDA submission in early 2027 [24][35] Regulatory and Competitive Landscape - **Legislative Risks**: Potential changes in TDAPA reimbursement structure could impact future revenue [35] - **Intellectual Property**: Strong IP protection for DefendCath and Rezzayo, with exclusivity extending into the 2030s [38][39] Conclusion - **Outlook**: CorMedix is positioned as a robust, diversified specialty pharmaceutical company with a strong financial profile and significant growth potential through its product pipeline and strategic initiatives [26]

Core Insights - The Zacks Rank system emphasizes earnings estimates and revisions to identify winning stocks, while also considering trends in value, growth, and momentum for strong stock picks [1][2] Company Analysis - CorMedix (CRMD) is highlighted as a stock to watch, currently holding a Zacks Rank of 1 (Strong Buy) and a Value grade of A, indicating it is among the best value stocks available [3] - CRMD has a Price-to-Book (P/B) ratio of 3.44, which is favorable compared to its industry's average P/B of 3.71. Over the past 52 weeks, CRMD's P/B has fluctuated between 3.10 and 14.04, with a median of 7.44 [4] - The Price-to-Sales (P/S) ratio for CRMD is 2.76, significantly lower than the industry's average P/S of 6.94, suggesting that CRMD may be undervalued [5] - The combination of CRMD's strong earnings outlook and favorable valuation metrics supports the conclusion that it is an impressive value stock at present [6]

Core Insights - CorMedix Therapeutics will present a corporate overview at the 44th annual J.P. Morgan Healthcare Conference on January 12, 2026, at 4:30pm PST [1][2] Company Overview - CorMedix Therapeutics is focused on developing and commercializing therapeutic products for life-threatening diseases and conditions [2] - The company is commercializing DefenCath® for the prevention of catheter-related bloodstream infections in adult patients undergoing hemodialysis via a central venous catheter [2] - Following the acquisition of Melinta Therapeutics LLC in August 2025, CorMedix is also commercializing a portfolio of anti-infective products, including MINOCIN®, REZZAYO®, VABOMERE®, ORBACTIV™, BAXDELA®, and KIMYRSA®, as well as TOPROL-XL® [2] Clinical Studies and Developments - CorMedix has ongoing clinical studies for DefenCath in Total Parenteral Nutrition (TPN) and Pediatric Hemodialysis populations [3] - The company intends to develop DefenCath as a catheter lock solution for use in other patient populations [3] - REZZAYO is currently approved for the treatment of candidemia and invasive candidiasis in adults, with an ongoing Phase III study for the prophylaxis of invasive fungal disease (IFD) in adult patients undergoing allogeneic bone marrow transplantation (BMT) [3] - Topline results of the Phase III study for REZZAYO are expected in Q2 2026 [3]

Core Insights - CorMedix Therapeutics (NASDAQ: CRMD) is focused on developing therapeutic products for life-threatening diseases, with a new price target set at $16 by Truist Financial, indicating an 84.95% potential upside from its current trading price of $7.44 [1][6] Financial Performance - The company reported preliminary unaudited net revenue of approximately $127 million for Q4 2025 and $400 million for the full year 2025, reflecting its core business activities [3][6] - CorMedix expects its adjusted EBITDA for Q4 to be between $77 million and $81 million, indicating strong operational performance [4][6] - The company has unaudited cash and short-term investments of approximately $148 million, showcasing a solid financial position [4] Market Activity - CRMD's market capitalization is approximately $579.5 million, with a trading volume of 20.76 million shares [5] - The stock has experienced significant volatility, with a current price of $7.36, down 34.15% from a previous high, and has fluctuated between a low of $7.22 and a high of $9.36 on the day [2][5]