CorMedix (AMEX: CRMD; Stock Twits: $CRMD) April 2011


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CorMedix Inc. (AMEX:CRMD) is a pharmaceutical company that seeks to in-license, develop and commercialize therapeutic products for the treatment of cardiac and kidney (cardiorenal) disease.

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CorMedix (AMEX: CRMD; Stock Twits: $CRMD) April 2011

  1. 1. Company Overview April 2011NYSE Amex: © 2011 CorMedix Inc. 1
  2. 2. Forward Looking StatementsThis presentation contains certain statements that constitute forward-looking statementswithin the meaning of the federal securities laws. Statements that are not historical facts,including statements about our beliefs and expectations, are forward-looking statements.These statements are not guarantees of future performance and involve risks,uncertainties and assumptions that are difficult to predict. The forward lookingstatements in this presentation include statements about our business, including resultsof clinical trials, potential indications for our product candidates, development timelinesand future events that have not yet occurred. Pharmaceutical development inherentlyinvolves significant risks and uncertainties, including the risks outlined in “Risk Factors”in our Annual Report on Form 10-K filed with the Securities and Exchange Commissionon March 11th, 2011. Our actual results may differ materially from our expectations dueto these risks and uncertainties, including our dependence on the success of our leadproduct candidates, and factors relating to regulatory approval, research anddevelopment, intellectual property protection, competition, industry environment, abilityto raise sufficient capital and other matters. Any forward-looking statements included inthis presentation are based on information available to us on the date of thispresentation. We undertake no obligation to update or revise any forward-lookingstatement, whether as a result of new information, future events or otherwise. © 2011 CorMedix Inc. 2
  3. 3. Experienced Team• John C. Houghton - President and CEO – Stryker Biotech - Global Head Sales and Marketing – Lederle/Wyeth, Rhone-Poulenc, Aventis• Mark A. Klausner, MD - Chief Medical Officer – Previously a Practicing Academic Nephrologist – J&J, Wyeth – Medical Affairs, Clinical R&D, Drug Safety• Brian Lenz - Chief Financial Officer – Public and Private company CFO experience – VioQuest Pharmaceuticals, Arno Therapeutics, KPMG, LLP © 2011 CorMedix Inc. 3
  4. 4. Company Highlights• Two products entering late stage clinical development – Neutrolin for the prevention of catheter related bloodstream infection (CRBI) and maintenance of catheter patency in hemodialysis (HD) patients – Deferiprone for the prevention of contrast induced nephropathy (CIN) in high-risk patients• Reduced development and regulatory risk – Neutrolin: Successful U.S. Pilot study; Established use in EU markets – Deferiprone: Available in 50 countries for other indications; Approved regulatory path (SPA) with FDA• Worldwide commercialization rights• Pipeline of additional products and indications © 2011 CorMedix Inc. 4
  5. 5. Product Pipeline PRODUCT INDICATION PRECLINICAL PILOT PIVOTAL Neutrolin Prevention (CRMD003) of CRBI* Thixotropic Prevention Gel (CRMD004) of CRBI PRODUCT INDICATION PRECLINICAL PHASE I PHASE II PHASE III Deferiprone Prevention (CRMD001) of CIN Deferiprone Treatment (CRMD001) of CKD Urine Diagnostic Catalytic Iron Test Test (CRMD002) * CRBI – Catheter Related Bloodstream Infection © 2011 CorMedix Inc. 5
  6. 6. Neutrolin © 2011 CorMedix Inc. 6
  7. 7. Central Venous Catheter Therapeutic Market in Hemodialysis • 80,000 HD catheter patients in the U.S., representing 12.5 million HD sessions per year • CVCs are subject to clotting and can result in catheter related bloodstream infection (CRBI) • 160,000 CRBI episodes in the U.S. alone1, 6,000 die annually • Cost to US healthcare system could approach $1 billion annually2 • Standard of care (heparin) does not prevent CRBI 1 Allon AJKD 51(2):165-168, 2008 2 Manierski Adv Chronic Kidney Dis 13(3):245, 2006 © 2011 CorMedix Inc. 7
  8. 8. Neutrolin: For the Prevention of CRBI• A catheter lock solution for the prevention of CRBI and maintenance of catheter patency in HD patients• Contains taurolidine, an anti-microbial – Prevents infection and formation of biofilm – No observed bacterial resistance - unlike antibiotics – >14,000 patients exposed to taurolidine – No systemic toxicity at levels 400x the amount contained in 5mL of Neutrolin• Contains citrate and heparin, both anti-coagulants – Prevents thrombus formation and clotting• Safe and well tolerated – No AE’s related to Neutrolin in previous catheter lock studies © 2011 CorMedix Inc. 8
  9. 9. Neutrolin Prevents Biofilm Formation Untreated 24 Hours Heparin 7 Months Neutrolin 5 MonthsBiofilm on Intravenous Biofilm with microbial No biofilm or microbialCatheter colonization completely colonization covers surfacePhotos taken from the Quarello, F et al, Blood Purif 2002; 20: 87-92 © 2011 CorMedix Inc. 9
  10. 10. Neutrolin Pilot Study Completed CRBI at 90 days was lower among patients who received Neutrolin than among control patients who received heparin Neutrolin 6 CRBI events per 1000 days 5 4 3 heparin 2 1 0 Pre Neutrolin Post ____ Neutrolin P < .001 P < .02 ------- heparinAdapted from: Allon M, Clin Infect Dis 2003; 36:1539-1544. © 2011 CorMedix Inc. 10
  11. 11. Neutrolin Demonstrated Effectiveness Average Neutrolin Study Number of patients duration Control group % patients without (days) infection 20 pts Neutrolin heparin 1 85 5000 u/mL 94 30 pts heparin case-control heparin 2 58 158 100 5000 u/mL 3 76 250 none 96 1. Allon M Clin Infect Dis (2003) 36 (12):1539-44 2. Betjes Nephrol Dial Transplant (2004) 19:1546-1551 3. Sodemann K et al Poster: ASN 2001 © 2011 CorMedix Inc. 11
  12. 12. Neutrolin Pivotal Study Plan• Prospective, multicenter, double blind, randomized, active control study•  400 patients; 15 months duration – (9 months recruitment, 6 months follow up)• Active control – heparin 1,000 U/mL• Co-primary endpoints: – Up to 180 day freedom from CRBI – Up to 180 day maintenance of catheter patency © 2011 CorMedix Inc. 12
  13. 13. Neutrolin Commercial Plan• Initial U.S. launch by CorMedix for HD patients with CVC – Establish Neutrolin as standard of care – Seek inclusion in renal guidelines and dialysis providers policy & procedure protocols – Seek quality of care endorsements for improvement in performance criteria in dialysis networks• Reimbursement – Apply for a J code - separately billable product (outside bundle) – Seek inclusion in bundle – Positive political environment: healthcare policy of preventative medicine, non- payment for hospital acquired infection• Apply for CE mark and commence commercial launch planning in EU• Apply for additional indications for non-HD CVCs and PICC lines © 2011 CorMedix Inc. 13
  14. 14. Neutrolin IP Overview• 6 issued patents providing protection through 2019-2025 – A method of inhibiting or preventing infection and blood coagulation at a medical prosthetic device using a pharmaceutical composition comprising taurolidine and citric acid – A locking solution comprising a taurinamide derivative, a biologically acceptable acid and low concentration heparin• Additional filings under prosecution to extend protection © 2011 CorMedix Inc. 14
  15. 15. Deferiprone © 2011 CorMedix Inc. 15
  16. 16. Contrast Induced Nephropathy (CIN) Market Overview• Cardiac interventions use X-ray and iodinated contrast dye to visualize coronary vessels• In “high risk” patients undergoing PCI* with Chronic Kidney Disease, the dye can cause acute kidney damage – otherwise known as CIN• CIN is the 3rd most common cause of hospital acquired renal insufficiency• CIN consequences go beyond kidney damage, including mortality and significant morbidity• No approved or near-term pharmaceutical therapies * PCI – Percutaneous Coronary Intervention © 2011 CorMedix Inc. 16
  17. 17. Catalytic Iron Causes Tissue and Cell Injury • CKD patient has a pre-existing excess of 7.0 catalytic iron and oxidative stress – “the Baseline perfect storm” 6.0 48 hours after IVP 5.0 P<0.001 • Contrast exposure is associated with a nmol / mg Cr 4.0 further increase in catalytic iron1 +115% 3.0 • Catalytic iron and oxidative stress 2.0 contribute significantly to the underlying cause of CIN 1.0 0.0 • Removal of catalytic iron shown to be Urinary catalytic iron protective in an animal model of CIN1 Rajapurkar M et al Urinary catalytic (bleomycin-detectable) iron following radiocontrast exposure in healthy kidney donors ASN 2006 © 2011 CorMedix Inc. 17
  18. 18. Deferiprone for Reducing Catalytic Iron• Deferiprone launched in 1999, available in >50 Ex-US countries for the treatment of Thalassemia Major• Deferiprone efficacy and safety is well characterized – several thousand patients treated• CorMedix in-licensed method of use and formulation patents of deferiprone• CorMedix has finalized a PK study showing the benefit of extended release formulations – less nausea/vomiting• Compared to other iron chelators, deferiprone is: – Superior at penetrating cells and sub-cellular compartments1 – Selectively binding catalytic iron 1 Glickstein et al. Blood 108: 3195, 2006 © 2011 CorMedix Inc. 18
  19. 19. Deferiprone Competitive Landscape Deferiprone Deferiprone Desferasirox Deferoxamine Attribute CRMD001 Ferriprox (1) Exjade (2) Desferal (3) Route Oral IR/ER (b.i.d.) Oral IR (t.i.d.) Oral daily I.V./S.C. Renal Toxicity No No Yes (Black Box) No Active drug in urine Yes Yes No Yes Method of use and formulation Yes No No No patents in cardiorenal disease Effective at redistributing iron/ Yes Yes No No membrane permeable Launch date N/A 1999 2006 1970s(1) Registered Trademark of Apopharma Inc.(2) Registered Trademarks of Novartis(3) Also known as desferrioxamine, desferoxamine © 2011 CorMedix Inc. 19
  20. 20. Deferiprone Development PlanRegulatory• Complete a small biomarker Phase II proof of concept trial• Commence planning for Phase III CIN study pending Phase II resultsClinical – Proof of concept trial• Commenced enrollment in Q2 2010• Double-blind, placebo controlled - 8 days deferiprone vs. placebo• High risk CKD population• 60 patients total, interim analysis at 30 patients completed – Favorable safety profile - no drug related SAEs• Primary endpoint: panel of biomarkers, which include: cystatin C, NGAL, LFABP• Secondary endpoints: clinical outcomes and persistent changes in kidney function © 2011 CorMedix Inc. 20
  21. 21. Deferiprone Commercial Plan• Specialty care sales force  50; focused on high decile catheter labs• Seek inclusion on catheter lab guidelines• Seek inclusion on Diagnosis-Related Group as a new tech add on• Market uptake expected to be faster than typical new product launches due to morbidity/mortality claim and absence of alternative therapies © 2011 CorMedix Inc. 21
  22. 22. Deferiprone IP Overview• Specific CIN patent under prosecution• Anticipate Hatch Waxman 5 year marketing exclusivity if gain first approval of deferiprone in U.S.• 8 issued patents for treating progressive kidney disease• Additional filings under prosecution © 2011 CorMedix Inc. 22
  23. 23. Achievements & Anticipated MilestonesTIMING ACHIEVEMENTS & MILESTONES2010  Deferiprone: Started phase II CIN study  Neutrolin: Commenced application process for CE mark in EU  Neutrolin: IDE submitted1H 2011  Deferiprone: Interim analysis of phase II CIN study  Neutrolin: Start of pivotal clinical study  Neutrolin: Submit CE mark application in EU2H 2011  Neutrolin: Potential launch in EU  Deferiprone: Data on phase II CIN study  Deferiprone: Commence planning for phase III CIN study  Neutrolin: Interim analysis of pivotal clinical study © 2011 CorMedix Inc. 23
  24. 24. Financial Overview (all figures in millions) Period Ended: 7/28/06 (Inception) - 12/31/10 12/31/10 R&D $5.5 $18.0 G&A $3.0 $7.8 Total Loss From Operations $8.5* $25.8 Cash Position $8.3 Common Shares Outstanding 11.4 Fully Diluted Shares Outstanding 17.8 *Loss From Operations Includes $3.5M of Non-Cash Expenses © 2011 CorMedix Inc. 24
  25. 25. Company Highlights• Two products entering late stage clinical development• Reduced development and regulatory risk• Worldwide commercialization rights• Pipeline of additional products and indications © 2011 CorMedix Inc. 25