CorMedix (NASDAQ: CRMD) reaffirms DefenCath 2027 sales outlook
Rhea-AI Filing Summary
CorMedix Inc. furnished an updated investor presentation and reaffirmed its prior guidance that full-year 2027 DefenCath sales are estimated at $100–$140 million, clarifying an inadvertent reference to $100–$125 million on a recent earnings call. The presentation outlines a broader growth plan, including 2026 revenue guidance of $300–$320 million and adjusted EBITDA of $100–$125 million, driven by DefenCath and a diversified anti-infective portfolio. Pro forma 2025 net revenue is shown at $401 million, with Q4 2025 DefenCath sales of $91 million and 79.1 million common shares outstanding as of December 31, 2025. CorMedix also highlights late-stage expansion opportunities for DefenCath in total parenteral nutrition and for REZZAYO in fungal prophylaxis, alongside a cash and short-term investment balance of $149 million.
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Insights
CorMedix pairs reaffirmed DefenCath guidance with an aggressive 2026–2027 growth and margin outlook.
CorMedix reiterates full-year
The company presents pro forma net revenue of
Pipeline slides emphasize phase 3 programs: DefenCath in total parenteral nutrition and REZZAYO prophylaxis, with data expected around
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Item 7.01 Regulation FD Disclosure
On March 6, 2026, CorMedix, Inc. (the “Company” or “CorMedix”) released an updated investor presentation, which is furnished as Exhibit 99.1, attached hereto. CorMedix is also reaffirming the guidance it previously provided in its press release, dated January 8, 2026, that the Company currently estimates full-year 2027 DefenCath sales in the range of $100 million to $140 million, notwithstanding an inadvertent statement regarding this guidance on its March 5, 2026 earnings call referring to a range of $100 million to $125 million.
The information in this Item 7.01 (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended (the “Securities Act”), or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Forward-Looking Statements
This Current Report on Form 8-K 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 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,” “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. 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 Current Report on Form 8-K. 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.
Item 9.01 Financial Statements and Exhibits
(d) Exhibits
| Exhibit No. | Description | |
| 99.1 | CorMedix Corporate Presentation | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
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SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| CORMEDIX INC. | ||
| Date: March 6, 2026 | By: | /s/ Joseph Todisco |
| Name: | Joseph Todisco | |
| Title: | Chief Executive Officer | |
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Exhibit 99.1
NOT FOR DISTRIBUTION WITHOUT THE PRIOR WRITTEN PERMISSION OF CORMEDIX THERAPEUTICS Corporate Presentation March 2026 CorMedix Therapeutics
NOT FOR DISTRIBUTION WITHOUT THE PRIOR WRITTEN PERMISSION OF CORMEDIX THERAPEUTICS 2 This presentation contains “forward - looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 , Section 27 A of the Securities Act, and Section 21 E of the Exchange Act of 1934 , 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,” “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 Therapeutics' product pipeline, results of the real - world studies, expectations regarding implementation and perceived benefits of CorMedix’s products, and estimates of total addressable market size . 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 presentation . 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 . Forward - looking statements involve estimates, expectations, projections, goals, forecasts, assumptions, risks and uncertainties . Actual outcomes or results may differ from anticipated results, sometimes materially . Factors that could cause actual results to differ include, but are not limited to : the strategies, plans and objectives of CorMedix Therapeutics (including it's growth strategy and corporate development initiatives) ; the status and timing of clinical studies, data analysis and communication of results ; expectations regarding reimbursement rates, customer utilization, and other factors impacting the demand for CorMedix Therapeutics' products ; the timing of regulatory approval of additional indications ; and projections of revenue, expenses and other financial items ; the timing, manner and amount of capital deployment ; ; the ability of CorMedix Therapeutics to achieve the identified synergies ; that operating costs, customer loss and business disruption (including, without limitation, difficulties in maintaining relationships with employees, customers or suppliers) may be greater than expected following the transaction ; the retention of certain key employees ; the expected benefits and success of Melinta’s products and product candidates ; potential litigation relating to the transaction that could be instituted against CorMedix or its directors ; rating agency actions and CorMedix’s ability to access short - and long - term debt markets on a timely and affordable basis ; general economic conditions that are less favorable than expected ; geopolitical developments and additional changes in international trade policies and relations, including tariffs ; and the ability of our products and product candidates to compete effectively against current and future competitors . Disclaimer
NOT FOR DISTRIBUTION WITHOUT THE PRIOR WRITTEN PERMISSION OF CORMEDIX THERAPEUTICS Introduction 3
NOT FOR DISTRIBUTION WITHOUT THE PRIOR WRITTEN PERMISSION OF CORMEDIX THERAPEUTICS 4 CorMedix Therapeutics is a commercial pharmaceutical company focused on providing innovative products for institutional markets has a diversified portfolio of specialty injectable therapies that is built upon a scalable commercial platform • Multiple “shots on goal” via pipeline, potential label expansion, and government partnerships – DefenCath ® (taurolidine and heparin) TPN indication would add an estimated 5MM annual infusions in the addressable market opportunity, an addressable market of ~$500 - $750MM data in 1H 2027 – REZZAYO ® ( rezafungin ) prophylaxis indication expansion would expand the addressable market 8 x to over $2B data in 2Q 2026 • Institutional specialization enables bolt - on acquisitions in addition to organic growth – Products sold to 500+ hospitals, infusion centers and clinics to date – Integrated field - based commercial team focused on hospital and acute care • High visibility into revenue streams – Revenue guidance of $300 – 320MM and adjusted EBITDA guidance of $100 – 125MM in 2026 – Eight diversified products in the current portfolio, including DefenCath , six anti - infectives, and a mature branded product – Cash flow generating Attractive Financial Profile Scalable Platform Diversified Growth Drivers
NOT FOR DISTRIBUTION WITHOUT THE PRIOR WRITTEN PERMISSION OF CORMEDIX THERAPEUTICS 5 CorMedix Therapeutics has a proven leadership team with a long track record of commercial outperformance PRIOR EXPERIENCE JOINED CORMEDIX THERAPEUTICS Joe Todisco Chairman & Chief Executive Officer 2022 • Chief Commercial Officer of Amneal Specialty • Co - founder and Chief Executive of Gemini Laboratories • Commercial Strategy and business development at Ranbaxy Beth Zelnick Kaufman EVP, Chief Legal and Compliance Officer, Corporate Secretary 2023 • Chief Legal Officer of Akorn Pharmaceuticals • Chief Legal Officer of The Broad Institute of MIT & Harvard • Assistant GC and Head of Government Affairs, Amneal • Actavis, Alpharma , Topcon America Liz Hurlburt EVP, Chief Operating Officer 2017 Led LOCK - IT - 100 clinical study program • VP of Clinical Operations at Gemphire Therapeutics • Additional renal area experience from Rockwell Medical • Co - Founder of BRAHN (Biomedical Research Alliance at Hypertension & Nephrology LLC) Michael Seckler EVP, Chief Commercial Officer 2026 • Chief Executive Officer of Evome Medical Technologies • Chief Operating Officer of FerGene • VP, Global Marketing & Corporate Communications at Ferring Susan Blum EVP, Chief Financial Officer 2025 • CFO of Melinta (previously VP of Finance & Chief Accounting Officer at Melinta, Controller at Melinta) • VP and Controller, Textura Corporation (now Oracle) • Director, External Reporting and Revenue, PDL / Facet Matt David, MD EVP, Chief Business Officer 2020 • Previously CFO and Interim CEO of CorMedix • Head of Strategy at Ovid Therapeutics • Life science focused investment banker • Pharma research analyst at Lehman Brothers
NOT FOR DISTRIBUTION WITHOUT THE PRIOR WRITTEN PERMISSION OF CORMEDIX THERAPEUTICS 6 Financial highlights * Per CorMedix 10K as of March 2, 2026 ** Excludes restricted cash (1) Pro Forma Net Revenue was prepared by combining the estimated financial results and for CorMedix and Melinta for the full fis cal year ended December 31, 2025, without further adjustment, as if the transaction had closed on January 1, 2025 (2) Adjusted EBITDA is a non - GAAP financial measure and excludes non - cash items such as stock - based compensation and certain non - rec urring items. The Company has provided 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 resul ts. Guidance Key Financials Balance Sheet at December 31, 2025 Key Statistics at December 31, 2025 FY 2025 Net Revenue (Pro Forma 1 ) $401 million FY 2024 Net Revenue (CorMedix) $44 million Q4 2025 Adjusted EBITDA 2 $77 million Q4 2025 Net Revenue $129 million FY 2026 DefenCath Sales $150 – 170 million FY 2026 Adjusted EBITDA 2 $100 – 125 million FY 2026 Revenue $300 – 320 million Common Shares Outstanding* 79.1 million Exchange NASDAQ Global Market Convertible Debt $150 million Cash and short - term investments** $149 million FY 2027 DefenCath Sales $100 – 140 million FY 2024 Net Revenue (Melinta) $120 million Q4 2025 DefenCath Sales $91 million
NOT FOR DISTRIBUTION WITHOUT THE PRIOR WRITTEN PERMISSION OF CORMEDIX THERAPEUTICS Product Class Current Therapeutic Area Product Taurolidine and heparin catheter lock solution CRBSI Echinocandin antifungal Candidemia and invasive candidiasis Tetracycline antibacterial Serious infections including Acinetobacter Carbapenems/ beta - lactamase inhibitor Complicated Urinary Tract Infections (cUTIs) Lipoglycopeptide antibacterial Acute Bacterial Skin and Skin Structure Infections (ABSSSI) Fluoroquinolone antibacterial ABSSSI and Community - Acquired Bacterial Pneumonia (CABP) Beta - adrenergic blocker Hypertension, Coronary Artery Disease, Heart Failure 7 The combined portfolio consists of a diversified and complementary set of assets Hospitals & IDNs Physician Office Infusion Centers Home Infusion Long Term Acute Care Centers Shared Call Points
NOT FOR DISTRIBUTION WITHOUT THE PRIOR WRITTEN PERMISSION OF CORMEDIX THERAPEUTICS Our Products 8
NOT FOR DISTRIBUTION WITHOUT THE PRIOR WRITTEN PERMISSION OF CORMEDIX THERAPEUTICS 9 DefenCath is well positioned to capture significant value across both outpatient and inpatient markets Source: CorMedix market research. DefenCath launched full scale for hemodialysis in July 2024 Strong commercial uptake with commercial agreements in place with 4 of the top 5 outpatient dialysis organizations , covering ~60% of the outpatient dialysis market Significant hemodialysis TAM of ~37MM vials outpatient and ~3.8MM vials inpatient 2H 2026 / 2027 Market Access Strategy TDAPA Buy & Bill Bundle Add - on • Drive continued volume with key partners • Pricing updates to reflect add - on payments GPOs/Health Systems – continued growth in access and utilization Medicare Advantage Contracting for long - term sustained pricing Anticipated changes to add - on payments in year 3 of TDAPA (Q3 ’26 – Q2 ’27) due to program mechanics
NOT FOR DISTRIBUTION WITHOUT THE PRIOR WRITTEN PERMISSION OF CORMEDIX THERAPEUTICS 0.46 0.13 0.0 0.2 0.4 0.6 Control (n=397) DefenCath (n=397) CRBSIs per 1,000 CD 10 DefenCath is the first and only FDA - approved catheter lock solution with significant risk reduction in catheter - related bloodstream infections (CRBSI) CRBSIs result in significant patient morbidity, mortality, and cost to healthcare systems demonstrated significant reduction in CRBSI risk in Ph III LOCK - IT - 100 Study - 71% p=0.001 of CRBSIs occur in hemodialysis patients with CVC access 1 Rajagopalan K, Massey K, Rajagopalan S, Imperiale - Hagerman S, Chew, P. Hospitalization Risk and Long - Term Complications Associ ated with Catheter - Related Bloodstream Infection Among Hemodialysis Patients [Abstract]. J Am Soc Nephrol 32, 2021: 350 2 Invasive methicillin - resistant Staphylococcus aureus infections among dialysis patients -- United States, 2005. MMWR, 2007. 56(9 ): p. 197 - 9 3 Massey K, Rajagopalan K, Rajagopalan S, Grossman A, Chew, P. Catheter - Related Bloodstream Infection Incidence and Associated M ortality Risk: Analysis of Merged USRDS - Medicare Claims [Abstract]. J Am Soc Nephrol 32, 2021: 344 70% ~4x longer hospital stays 1,2 ~2x more hospitalizations per year 1 ~2x higher cost of hospital stay 1,2 ~3x more likely to die within 90 days 3
NOT FOR DISTRIBUTION WITHOUT THE PRIOR WRITTEN PERMISSION OF CORMEDIX THERAPEUTICS 11 DefenCath – US Renal Care positive real world evidence interim results Design Retrospective analysis of outpatients receiving dialysis through a CVC at USRC • 23,663 patients in pre - intervention (July 1, 2022 – June 30, 2024) • 7,051 patients that received at least one dose of DefenCath (July 1, 2024 – Sept. 30, 2025) Outcomes • CRBSI Definition: ICD - 10 diagnosis coding for bloodstream infection due to CVC ; This represents the most definitive measure of CLABSI • Hospitalization secondary to CRBSI was defined as hospitalizations with CRBSI listed as the primary admission and/or discharge diagnosis. Data were annualized to account for differences in study periods Study Population 7,051 matched patients in each cohort • Patients were matched based on age (18 - 64 or ≥65), sex, minority status, and Charlson Comorbidity Index Interim Results 72% reduction in CRBSI (infection rate/1,000 catheter days) 70% reduction in the annualized number of hospitalizations secondary to CRBSI
NOT FOR DISTRIBUTION WITHOUT THE PRIOR WRITTEN PERMISSION OF CORMEDIX THERAPEUTICS Next generation echinocandin with once - weekly dosing schedule – highly simplifies management of candidemia and invasive candidiasis Strong commercial uptake – On formulary at 55+ large health systems – 100+ new accounts purchased in Q4’25 – 200+ repeat customers TAM for treatment indication is ~$250 – $350MM, and expanded indication for prophylaxis of invasive fungal infections is underway with a significantly larger TAM of >$2B Patent coverage through 2038 – NCE exclusivity with GAIN extension until 2033 , plus ODE until 2035 – Composition of matter patent coverage until 2032 , potential PTE to 2036 – Composition and treatment patent coverage until 2038 12 REZZAYO disrupts the standard of care of daily echinocandins with its once - weekly dosing schedule, highly simplifying management of candidemia and invasive candidiasis Source: CorMedix market research, Datamonitor ; Cancer.org; bloodstemcell.hrsa.gov. REZZAYO – Product overview
NOT FOR DISTRIBUTION WITHOUT THE PRIOR WRITTEN PERMISSION OF CORMEDIX THERAPEUTICS • Differentiated triple MOA that treats ABSSSI caused by gram - positive pathogens in adult patients – Single, one - time infusion avoids burden of multi - dose infusions and ensures adherence without requiring a PICC line or hospital stay – KIMYRSA is a 1 - hour infusion, while ORBACTIV is a lower - cost, 3 - hour infusion, providing flexibility based on account needs • Achieved ~$20MM revenue in 2024 & ~$26MM revenue in 2025 • Meropenem and vaborbactam combination specifically designed to address the challenge of CRE – Demonstrated differentiated outcomes for patients with complicated UTIs with CRE and unsurpassed coverage for KPC - producing bacteria • Achieved ~$39MM revenue in 2024 & ~$47MM revenue in 2025 • Highly differentiated tetracycline with safety, tolerability and strong placement (1L/2L) in IDSA guidance as key drivers of usage – One of limited treatment options indicated for infections from Acinetobacter species • Single - dose method of treatment patent coverage until 2029 • High - purity composition patent coverage until 2035 • NCE exclusivity with GAIN extension until 2027 • Compound patent coverage until 2031 • Method of treatment patent coverage until 2039 • Method of treatment patent coverage until 2031 • Drug product formulation patent coverage until 2032 13 MINOCIN, VABOMERE, and the ORI franchise (KIMYRSA/ORBACTIV) are highly differentiated anti - infectives with IP coverage IP & Exclusivity Overview & Highlights Note: CRE = carbapenem - resistant Enterobacterales , KPC = Klebsiella pneumoniae carbapenemase , IDSA – Infectious Diseases Society of America, ABSSSI = acute bacteria skin and skin structure infections, MRSA = Methicillin - resistant Staphylococcus aureus, PICC = peripherally inserted central catheter. Source: IDSA guidelines, UpToDate.
NOT FOR DISTRIBUTION WITHOUT THE PRIOR WRITTEN PERMISSION OF CORMEDIX THERAPEUTICS Expansion & Growth Opportunities 14
NOT FOR DISTRIBUTION WITHOUT THE PRIOR WRITTEN PERMISSION OF CORMEDIX THERAPEUTICS 15 CorMedix Therapeutics is well positioned to continue to create value as a diversified specialty pharma business with a compelling growth path Inflecting Commercial - Stage Company Strong Initial DefenCath Launch Broad Dialysis Market Penetration Durable, Diversified Revenue Streams Melinta Acquisition, Expanding Portfolio Track Record of Successfully Bringing Drugs to Market Platform for Full Suite of Institutional Products Operating at Scale High - Growth, Cash Flow Generating Business Diversified Commercial Leader Single Indication Past Diversified Portfolio with Multiple Indications & Assets Today Dynamic Institutional Platform Longer Term Ongoing Ph III studies Strategic BD and financial flexibility to pursue growth opportunities
NOT FOR DISTRIBUTION WITHOUT THE PRIOR WRITTEN PERMISSION OF CORMEDIX THERAPEUTICS 16 CorMedix Therapeutics development stage pipeline has potential to drive meaningful value over coming years Commercial Ph III / Registrational Ph II Ph I Pre - Clinical Therapeutic Area Expansion Product Prophylaxis* Pneumocystis Pneumonia in HIV Adults* Chronic Pulmonary Aspergillosis* Total Parenteral Nutrition (TPN) Hemodialysis (Pediatric) Pipeline and Growth Opportunities Ph III Ph III Ph III *Study being run by Mundipharma Ph II Ph II 2026 Analyst Day I Introduction
NOT FOR DISTRIBUTION WITHOUT THE PRIOR WRITTEN PERMISSION OF CORMEDIX THERAPEUTICS 17 Expanded indication Ph 3 study ( ReSPECT ) for prophylaxis of invasive fungal infections is underway • Study for the prevention of invasive fungal diseases in subjects undergoing allogeneic blood and marrow transplantation (BMT) • Primary Endpoint – Non - inferiority of Rezafungin vs. SAR for fungal - free survival at Day 90 (+/ - 7 days) (FDA) – Then assess superiority of Rezafungin over SAR for fungal - free survival at Day 90 (+/ - 7 days) (EMA) • Select Secondary Endpoint – Evaluate discontinuation of Rezafungin compared to the SAR secondary to toxicity or intolerance at Day 90 (+/ - 7 days) • Study site locations: • Company announced completion of enrollment in late September 2025. Standard Antimicrobial Regimen (SAR) Arm US Canada Belgium France Germany Italy Spain Turkey UK 2:1 randomized double blind • 13 - week treatment of Rezafungin IV • 400mg loading dose in Week 1 • 200mg once weekly • Placebo for SAR • Fluconazole (400mg QD) • Posaconazole (300mg BID D1/daily) • Trimethoprim/sulfamethoxazole (TMP/SMX) • Placebo for Rezafungin injection ReSPECT Ph III Global Multicenter Study (Data Expected Q2 2026)
NOT FOR DISTRIBUTION WITHOUT THE PRIOR WRITTEN PERMISSION OF CORMEDIX THERAPEUTICS ! % 7$0 $FURVV DOO KHPDWRORJ\ RQFRORJ\ DQG WUDQVSODQW SDWLHQW XVDJH 3URSK\OD[LV $GGUHVVDEOH 3DWLHQW 3RSXODWLRQ a % a % &DQGLGD $VSHUJLOOXV 3-3 $OOR $XWR $0/ 627 2WKHU 18 REZZAYO Prophy – Commercial Opportunity Expands portfolio and reach into hematology/oncology and transplant markets Larger patient population , with potentially for additional addressable patients for hematological malignancies and those on highly immunosuppressive therapies Longer treatment course (13+ weeks for prophylaxis vs. 4 weeks for treatment) REZZAYO’s label expansion into prophylaxis could unlock an opportunity of an additional addressable market representing a >$2B TAM Growth Opportunity TAM assumes REZZAYO price across this patient population Note: TAM = Total Addressable Market, Allo = Allogeneic Bone Marrow Transplant, Auto = Autologous Bone Marrow Transplant, AML = Acute Myeloid Leukemia, SOT = Solid Organ Transplant, PJP = Pneumocystis Jiroveci Pneumonia Source: Internal market research, Datamonitor , Cancer.org, bloodstemcell.hrsa.gov.
NOT FOR DISTRIBUTION WITHOUT THE PRIOR WRITTEN PERMISSION OF CORMEDIX THERAPEUTICS 19 Expanded indication Ph 3 study (NUTRI - LOCK) for CLABSIs in adult TPN patients is underway Program Overview: A Ph 3, randomized, double - blind, adaptive, 2 - arm, study assessing the safety and efficacy of DefenCath in reducing central line - associated bloodstream infections (CLABSIs) in adult patients receiving total parenteral nutrition (TPN) via central venous catheter (CVC) Subjects 90 target; 200 max Enrollment is on - going Total Sites in the U.S. & Turkey 25 Ph 3, Duration of treatment 12 months Randomization 2:1 (60:30) To evaluate the efficacy of DefenCath in reducing the incidence of CLABSI over 12 months compared with heparin as a catheter lock solution (CLS) Primary Endpoint
NOT FOR DISTRIBUTION WITHOUT THE PRIOR WRITTEN PERMISSION OF CORMEDIX THERAPEUTICS 20 DefenCath In Total Parenteral Nutrition • Approximately 40,000 patients in the US receiving outpatient/home TPN • CLABSIs occur in up to 26% of TPN patients with a CVC • A majority of TPN patients receive daily lock therapy • Components of TPN could enhance risk of infection • A majority of these patients received TPN at home by non - healthcare personnel • Heparin locks are the current standard of care, lacking an approved and widely available antimicrobial option Note: TPN = Total Parenteral Nutrition, CLABSI = Central Line Associated Bloodstream Infection, CVC = Central Venous Catheter. Source: CorMedix Market Research, CDC, UpToDate, Ross 2016 American Journal of Infection Control, Opilla 2008 American Journal of Infection Control, Thomas Jefferson University Hospital, Beghetto 2005 Journal of Parenteral Nutrition, Duke Health, Milstone 2010 Infection Control and Hospital Epidemiology. Patient Characterization US Total Parenteral Nutrition Total Addressable Market ( 2024E) 1.55 3.13 0.25 0.51 1.80 3.64 0 1 2 3 4 Inpatient Home Total Infusions (MM) Ports or IVs CVCs, PICCs, or Midlines DefenCath Addressable Infusions ~ $500 - 750MM Total Addressable Market TPN represents an opportunity of ~4.7MM infusions per year across outpatient and inpatient settings, an addressable market of ~$500 - 750MM
NOT FOR DISTRIBUTION WITHOUT THE PRIOR WRITTEN PERMISSION OF CORMEDIX THERAPEUTICS Strategic Investment in In 2025, CorMedix Therapeutics made a strategic investment in Talphera in return for the right of first negotiation . This period will be triggered by announcement of Phase III NEPHRO study results for Niyad ( nafamostat mesylate) Niyad provides an opportunity to acquire a significant improvement to standard of care in continuous renal replacement therapy (CRRT) which could provide an additional growth driver in 2027 and beyond . 21 CorMedix Therapeutics has strong financial flexibility to pursue business development opportunities Strong Cash Position CorMedix Therapeutics as of December 31, 2025 has a strong cash position consisting of ~$149MM of cash and short - term investments and sustainable profitability from currently marketed products. The strong cash position in tandem with a strong base of sustainable profitability puts CorMedix Therapeutics in a position to continue to pursue accretive business development opportunities.
NOT FOR DISTRIBUTION WITHOUT THE PRIOR WRITTEN PERMISSION OF CORMEDIX THERAPEUTICS 22 Anticipated company milestones 2 H 2026 / 1H 2027 1 H 2026 • CorMedix Therapeutics 1Q 2026 earnings and business updates • REZZAYO prophylaxis study clinical data • Medicare Advantage updates • Conference presence at TANDEM, ASDIN, NKF, MAD ID, and APIC • CorMedix Therapeutics earnings and business updates • Talphera Niyad study clinical data • TPN study updates and clinical data • REZZAYO prophylaxis sNDA submission and potential approval • CMS updates for 2027 add - on payments for FFS patients
NOT FOR DISTRIBUTION WITHOUT THE PRIOR WRITTEN PERMISSION OF CORMEDIX THERAPEUTICS 23 CorMedix Therapeutics key highlights Commercial specialty pharma business with portfolio of products, revenue scale, and a dynamic commercial platform in acute care poised for organic and inorganic growth 1 Portfolio of differentiated hospital and acute care products 2 Strong financial position; sustained profitability 5 DefenCath launch has been successful; recent positive RWE study data 3 Two significant growth opportunities in pipeline, including DefenCath TPN indication and REZZAYO prophylaxis indication 4 Highly experienced leadership team 6
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