Meropenem/Vaborbactam

Careers Contact Us Healthcare Professionals ‒ Q4 2025 Unaudited Net Revenue of Approximately $127 million ‒ ‒ FY 2025 Unaudited Pro Forma Net Revenue of Approximately $400 million ‒ ‒ Expects Q4 Adjusted EBITDA of Between $77 million and $81 million ‒ ‒ Unaudited Cash and Short-term Investments of Approximately $148 million ‒ Berkeley Heights, NJ – January 8, 2026 – CorMedix Therapeutics (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions, today announces its preliminary unaudited fourth quarter 2025 and full-year 2025 results, and provides guidance and an update on its business. These include the following key updates: CorMedix announces preliminary, unaudited financial results for Q4 and FY 2025, including net revenue of approximately $127 million and $310 million, for Q4 2025 and FY 2025, respectively, FY 2025 Pro Forma net revenue(1) of approximately $400 million, and Q4 2025 adjusted EBITDA(2) in the range of $77 million to $81 million. The Company reports preliminary unaudited cash and short-term investments, as of December 31, 2025, of approximately $148 million. CorMedix expects clinical data from the Phase 3 ReSPECT study of REZZAYO® (rezafungin for injection) in the prophylaxis of invasive fungal infection in adult patients undergoing allogeneic blood and marrow transplant in Q2 2026. In addition, the ongoing Phase 3 study of taurolidine/heparin catheter lock solution in TPN patients continues to enroll patients with targeted completion in early 2027. The Company continues to see strong utilization and patient growth for DefenCath® (taurolidine and heparin) by its outpatient dialysis organization customers. On July 1, 2026, DefenCath’s TDAPA reimbursement transitions into a post-TDAPA Add-On Adjustment, the calculation of which is determined by CMS. As a result of the methodology utilized by CMS, the level of reimbursement provided to institutions treating dialysis patients will significantly decline, and as a result, CorMedix expects a corresponding reduction to its net pricing for DefenCath in Q3 and Q4 of 2026. If CMS utilizes the same methodology to calculate the 2027 post-TDAPA Add-On Adjustment, which will be effective on January 1, 2027, CorMedix estimates the value of the Add-On Adjustment will be 3x – 5x higher than that granted for Q3 and Q4 of 2026, which the Company expects would result in higher DefenCath sales prices in 2027 relative to H2 2026. CorMedix is introducing FY 2026 Revenue guidance of $300 million to $320 million, which includes $150 million to $170 million for DefenCath. 2026 DefenCath revenue guidance is heavily weighted toward H1 2026 and assumes modest utilization growth, which the Company expects will offset some of the price erosion over the course of the year. Based on the assumption of a higher net selling price in 2027 relative to H2 2026, the Company currently estimates full-year 2027 DefenCath sales in the range of $100 million to $140 million. DefenCath guidance for 2026 and 2027 assumes the maintenance of its current outpatient dialysis utilization run-rate with existing customers, and excludes any potential upside from new outpatient dialysis customers, increased utilization due to anticipated Medicare Advantage contracting, or any change in reimbursement due to pending TDAPA legislation. In addition, management has operationalized synergies of approximately $35 million, on a full-year run rate basis, related to the acquisition of Melinta and is now focused on driving growth strategies for the business. The Company is estimating FY 2026 operating expenses of $145 million to $160 million, excluding non-cash items and one-time expenses, with the upper end of the spending range contingent upon positive Phase 3 data related to the ReSPECT study and a potential acceleration of enrollment in the DefenCath TPN study. Based on these estimates, CorMedix estimates FY 2026 Adjusted EBITDA in the range of $100 million to $125 million. CorMedix is excited to announce that it will hold an Analyst Day on February 10, 2026, during which it will provide significant background on the medical need and the market potential for its key pipeline assets of REZZAYO in prophylaxis and DefenCath in TPN, as well as insights on the future strategic direction for the business. Details will be forthcoming. Joseph Todisco, CorMedix Therapeutics CEO, commented, “I’m proud to announce our preliminary Q4 and FY 2025 results today, including surpassing our guidance for 2025. 2025 was a transformational year for CorMedix, as we evolved beyond a single-product company to an organization with multiple growth drivers and pipeline assets. We closed 2025 in a strong cash position, which we expect to further bolster over the coming year, providing the Company with financial flexibility to drive value for shareholders. With our new leadership team in place and multiple near-term pipeline catalysts, I am excited about the long-term potential for CorMedix Therapeutics.” The preliminary financial information presented in this press release is based on CorMedix’s current expectations and may be adjusted as a result of, among other things, the completion of our internal review process and the completion of customary annual audit procedures. FY 2025 Unaudited Pro Forma Net Revenue was prepared by combining the estimated financial results and for CorMedix and Melinta for the full fiscal year ended December 31, 2025, without further adjustment, as if the transaction had closed on January 1, 2025. Adjusted EBITDA is a non-GAAP financial measure and excludes non-cash items such as depreciation, amortization and stock-based compensation, and certain non-recurring items. The Company expects to provide a reconciliation of Adjusted EBITDA to the most comparable GAAP measure in its earnings release relating to the fourth quarter and full year 2025 financial results. Such reconciliation is not included in this release because CorMedix is currently finalizing certain amounts that would be required to be included in the U.S. GAAP measure or the individual adjustments for such reconciliation. About CorMedix CorMedix Therapeutics is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening conditions and diseases. CorMedix is commercializing DefenCath® (taurolidine and heparin) for the prevention of catheter-related bloodstream infections in adult patients undergoing hemodialysis via a central venous catheter. Following its August 2025 acquisition of Melinta Therapeutics LLC, CorMedix is also commercializing a portfolio of anti-infective products, including MINOCIN® (minocycline) for Injection, REZZAYO® (rezafungin), VABOMERE® (meropenem and vaborbactam), ORBACTIV™ (oritavancin), BAXDELA® (delafloxacin), and KIMYRSA® (oritavancin), as well as TOPROL-XL® (metoprolol succinate). CorMedix has ongoing clinical studies for DefenCath in Total Parenteral Nutrition (TPN) and Pediatric Hemodialysis populations and also intends to develop DefenCath as a catheter lock solution for use in other patient populations. REZZAYO is currently approved for the treatment of candidemia and invasive candidiasis in adults, with an ongoing Phase III study for the prophylaxis of IFD in adult patients undergoing allogeneic BMT. Topline results of the Phase III study for REZZAYO are expected in Q2 2026. For more information visit: www.cormedix.com or www.melinta.com. Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act, and Section 21E of the Exchange, as amended (the “Exchange Act”), that are subject to risks and uncertainties. Forward-looking statements are often identified by the use of words such as, but not limited to, “anticipate,” “believe,” “can,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “will,” “plan,” “project,” “seek,” “should,” “target,” “will,” “would,” and similar expressions or variations intended to identify forward-looking statements. All statements, other than statements of historical facts, regarding management’s expectations, beliefs, goals, plans or CorMedix’s prospects should be considered forward-looking statements including, but not limited to statements regarding financial guidance, sales, revenue and operating expense estimates, expectations regarding product utilization, product reimbursement rates, synergy estimates and timing, expectations and timing regarding clinical studies and development and expectations of CorMedix’s product pipeline, results of the real-world study, expectations regarding implementation and perceived benefits of CorMedix’s products. Readers are cautioned that actual results may differ materially from projections or estimates due to a variety of important factors, and readers are directed to the Risk Factors identified in CorMedix’s filings with the SEC, including its most recent Annual Report on Form 10-K, copies of which are available free of charge at the SEC’s website at www.sec.gov or upon request from CorMedix. CorMedix may not actually achieve the goals or plans described in its forward-looking statements, and such forward-looking statements speak only as of the date of this press release. Investors should not place undue reliance on these statements. CorMedix assumes no obligation and does not intend to update these forward-looking statements, except as required by law. Investor Contact: Dan Ferry Managing Director LifeSci Advisors daniel@lifesciadvisors.com (617) 430-7576

DefenCath® demonstrated a 72% reduction in CRBSI and 70% reduction in hospitalizations secondary to CRBSIBERKELEY HEIGHTS, N.J., Dec. 18, 2025 (GLOBE NEWSWIRE) -- CorMedix Therapeutics (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions, today announced interim results for the Company’s ongoing real-world evidence study being conducted in conjunction with U.S. Renal Care’s (USRC) use of DefenCath in adult hemodialysis patients with central venous catheters. CorMedix and USRC commenced the real-world evidence study upon outpatient commercial launch in July 2024. The study is designed to demonstrate the impact of the broad use of DefenCath in a real-world setting and prospectively assess rates of catheter-related bloodstream infections (CRBSI), as well as hospitalizations secondary to these infections. The study is designed to evaluate these data points for two years. Currently, more than 3,000 patients per month are receiving DefenCath on a routine basis at USRC facilities. CorMedix conducted a preliminary analysis of interim data for approximately 7,000 patients having received at least one dose of DefenCath in Year 1. Based on CorMedix’s analysis of the data available through September 30, 2025, compared to historical controls, use of DefenCath demonstrated an overall 72% reduction in CRBSI, and a 70% reduction in hospitalizations secondary to CRBSI. The Company believes this represents a meaningful reduction in risk in some of the most vulnerable patients as well as a significant source of cost savings to the healthcare community and payors. CMS spends more than $3 billion per year on costs associated with CRBSI in the ESRD patient population, as the average CRBSI-related hospitalization is estimated to cost approximately $63,000, and up to $110,000 per incident when accounting for other sequelae. Joseph Todisco, CEO of CorMedix, commented, “We are proud to announce interim results for our ongoing real-world evidence study with our partners at USRC. As one of our earliest outpatient customers, they have undertaken a significant effort in working with us on this important long-term study and ensuring patient access to DefenCath to prevent CRBSIs in hemodialysis patients at risk. We are now utilizing this data in discussions with customers and payers as we seek to broaden access to DefenCath and establish long-term reimbursement with Medicare Advantage.” Geoffrey A. Block, MD, FASN, Associate Chief Medical Officer and Senior Vice President of Clinical Research and Medial Affairs at U.S. Renal Care stated that, “Our organization is deeply committed to advancing innovative therapies for our patients, and we are encouraged by the reduction in both serious infections and hospitalizations demonstrated in these preliminary results.” Paul T. Conway, Vice President and Chair of Policy for the American Association of Kidney Patients (AAKP) and a 48-year kidney patient stated, "Every kidney patient receiving hemodialysis understands the inherent and serious risks posed by catheter-related bloodstream infections, including repeat hospitalizations, exposure to powerful IV antibiotics, jeopardization of their transplant readiness and increased mortality. As the largest kidney patient organization in the nation, AAKP welcomes this new and compelling information about DefenCath and the opportunity to better protect highly vulnerable dialysis patients while simultaneously reducing infection incidents and hospital admissions. We believe this data also strongly reinforces the ongoing collaborations among healthcare providers, patient advocates and elected leaders committed to transforming status quo dialysis care by addressing the long-standing and unmet need for infection prevention measures that lower hospitalizations, reduce healthcare utilization and limit costs to taxpayers.” Secondary data points of missed treatment sessions, antibiotic utilization, and tPA utilization are also being assessed and may be announced with additional real-world evidence data in the future. CorMedix believes these data from this large, prospective, ongoing real-world study further underscore the LOCK-IT 100 clinical study results on which the FDA approval of DefenCath for ESRD hemodialysis patients was based. The Company expects to continue to discuss with customers and payors, such as Medicare Advantage plans, to emphasize the economic value of long-term infection prevention in these patients. About CorMedix CorMedix Therapeutics is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening conditions and diseases. CorMedix is commercializing DefenCath® (taurolidine and heparin) for the prevention of catheter-related bloodstream infections in adult patients undergoing hemodialysis via a central venous catheter. Following its August 2025 acquisition of Melinta Therapeutics LLC, CorMedix is also commercializing a portfolio of anti-infective products, including MINOCIN® (minocycline) for Injection, REZZAYO® (rezafungin), VABOMERE® (meropenem and vaborbactam), ORBACTIV™ (oritavancin), BAXDELA® (delafloxacin), and KIMYRSA® (oritavancin), as well as TOPROL-XL® (metoprolol succinate). CorMedix has ongoing clinical studies for DefenCath in Total Parenteral Nutrition (TPN) and Pediatric Hemodialysis populations and also intends to develop DefenCath as a catheter lock solution for use in other patient populations. REZZAYO is currently approved for the treatment of candidemia and invasive candidiasis in adults, with an ongoing Phase III study for the prophylaxis of IFD in adult patients undergoing allogeneic BMT. Topline results of the Phase III study for REZZAYO are expected in Q2 2026. For more information visit: www.cormedix.com or www.melinta.com. Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act, and Section 21E of the Exchange, as amended (the “Exchange Act”), that are subject to risks and uncertainties. Forward-looking statements are often identified by the use of words such as, but not limited to, “anticipate,” “believe,” “can,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “will,” “plan,” “project,” “seek,” “should,” “target,” “will,” “would,” and similar expressions or variations intended to identify forward-looking statements. All statements, other than statements of historical facts, regarding management’s expectations, beliefs, goals, plans or CorMedix’s prospects should be considered forward-looking statements including, but not limited to statements regarding financial guidance, sales estimates, synergy estimates and timing, expectations and timing regarding clinical studies and development and expectations of CorMedix’s product pipeline, results of the real-world study, expectations regarding implementation and perceived benefits of CorMedix’s products. Readers are cautioned that actual results may differ materially from projections or estimates due to a variety of important factors, and readers are directed to the Risk Factors identified in CorMedix’s filings with the SEC, including its most recent Annual Report on Form 10-K, copies of which are available free of charge at the SEC’s website at www.sec.gov or upon request from CorMedix. CorMedix may not actually achieve the goals or plans described in its forward-looking statements, and such forward-looking statements speak only as of the date of this press release. Investors should not place undue reliance on these statements. CorMedix assumes no obligation and does not intend to update these forward-looking statements, except as required by law. Investor Contact:Dan FerryManaging DirectorLifeSci Advisorsdaniel@lifesciadvisors.com(617) 430-7576