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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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© 2011 CorMedix Inc. 1
Company Overview
April 2011
NYSE Amex: CRMD
www.cormedix.com
Forward Looking Statements
This 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 inherently
© 2011 CorMedix Inc. 2
and 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.
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
© 2011 CorMedix Inc.
– 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
3
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
© 2011 CorMedix Inc.
• 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
4
Product Pipeline
INDICATIONPRODUCT PRECLINICAL PILOT PIVOTAL
Neutrolin(CRMD003)
Prevention of CRBI*
Thixotropic Gel (CRMD004)
Prevention of CRBI
© 2011 CorMedix Inc.
INDICATIONPRODUCT PRECLINICAL PHASE I PHASE II PHASE III
Urine Catalytic Iron Test (CRMD002)
Deferiprone(CRMD001)
Deferiprone(CRMD001)
Diagnostic Test
Treatment of CKD
Prevention of CIN
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* CRBI – Catheter Related Bloodstream Infection
Neutrolin
© 2011 CorMedix Inc. 6
• 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)
Central Venous Catheter Therapeutic Market in Hemodialysis
© 2011 CorMedix Inc.
• 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, 20082 Manierski Adv Chronic Kidney Dis 13(3):245, 2006
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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
© 2011 CorMedix Inc.
– >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
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Neutrolin Prevents Biofilm Formation
Untreated 24 Hours Heparin 7 Months Neutrolin 5 Months
© 2011 CorMedix Inc.
Photos taken from the Quarello, F et al, Blood Purif 2002; 20: 87-92
Biofilm on Intravenous Catheter
Biofilm with microbial colonization completely covers surface
No biofilm or microbial colonization
9
Neutrolin Pilot Study Completed
Neutrolin
4
5
6
CR
BI
eve
nts
pe
r 1
00
0 d
ays
CRBI at 90 days was lower among patients who received Neutrolin than among control patients who received heparin
© 2011 CorMedix Inc.
Adapted from: Allon M, Clin Infect Dis 2003; 36:1539-1544.
P < .001____ Neutrolin
------- heparin
heparin
P < .02
0
1
2
3
Pre Neutrolin PostC
RB
I e
ve
nts
pe
r 1
00
0 d
ays
10
Neutrolin Demonstrated Effectiveness
Study Number of patients
Average
duration
(days)
Control groupNeutrolin
% patients without infection
120 pts Neutrolin
30 pts heparin85
heparin 5000 u/mL
case-control94
© 2011 CorMedix Inc.
2 58 158heparin
5000 u/mL100
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
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Neutrolin Pivotal Study Plan
• Prospective, multicenter, double blind, randomized, active control study
• 400 patients; 15 months duration – (9 months recruitment, 6 months follow up)
© 2011 CorMedix Inc.
– (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
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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
© 2011 CorMedix Inc.
• 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
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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
© 2011 CorMedix Inc.
acceptable acid and low concentration heparin
• Additional filings under prosecution to extend protection
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Deferiprone
© 2011 CorMedix Inc. 15
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
© 2011 CorMedix Inc.
insufficiency
• CIN consequences go beyond kidney damage, including mortality and significant morbidity
• No approved or near-term pharmaceutical therapies
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* PCI – Percutaneous Coronary Intervention
Catalytic Iron Causes Tissue and Cell Injury
• CKD patient has a pre-existing excess of catalytic iron and oxidative stress – “the perfect storm”
• Contrast exposure is associated with a further increase in catalytic iron1
4.0
5.0
6.0
7.0Baseline
48 hours after IVP
P<0.001
+115%
nm
ol /
mg C
r
© 2011 CorMedix Inc.
• Catalytic iron and oxidative stress contribute significantly to the underlying cause of CIN
• Removal of catalytic iron shown to be protective in an animal model of CIN
1 Rajapurkar M et al Urinary catalytic (bleomycin-detectable) iron following radiocontrast exposure in healthy kidney donors ASN 2006
0.0
1.0
2.0
3.0
Urinary catalytic iron
nm
ol /
mg C
r
17
• 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 for Reducing Catalytic Iron
© 2011 CorMedix Inc.
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
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Deferiprone Competitive Landscape
AttributeDeferiproneCRMD001
DeferiproneFerriprox (1)
DesferasiroxExjade (2)
DeferoxamineDesferal (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
© 2011 CorMedix Inc. 19
Active drug in urine Yes Yes No Yes
Method of use and formulation patents in cardiorenal disease
Yes No No No
Effective at redistributing iron/ membrane permeable
Yes Yes No No
Launch date N/A 1999 2006 1970s
(1) Registered Trademark of Apopharma Inc.(2) Registered Trademarks of Novartis(3) Also known as desferrioxamine, desferoxamine
Deferiprone Development Plan
Regulatory
• Complete a small biomarker Phase II proof of concept trial
• Commence planning for Phase III CIN study pending Phase II results
Clinical – Proof of concept trial
• Commenced enrollment in Q2 2010
• Double-blind, placebo controlled - 8 days deferiprone vs. placebo
© 2011 CorMedix Inc.
• 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
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• 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
Deferiprone Commercial Plan
© 2011 CorMedix Inc.
• Market uptake expected to be faster than typical new product launches due to morbidity/mortality claim and absence of alternative therapies
21
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
© 2011 CorMedix Inc.
• 8 issued patents for treating progressive kidney disease
• Additional filings under prosecution
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Neutrolin: IDE submitted
Neutrolin: Commenced application process for CE mark in EU
Deferiprone: Started phase II CIN study
Deferiprone: Interim analysis of phase II CIN study
TIMINGTIMING ACHIEVEMENTS & MILESTONESACHIEVEMENTS & MILESTONES
2010
1H 2011
Achievements & Anticipated Milestones
© 2011 CorMedix Inc.
Deferiprone: Interim analysis of phase II CIN study1H 2011
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2H 2011
Neutrolin: Start of pivotal clinical study
Neutrolin: Potential launch in EU
Deferiprone: Data on phase II CIN study
Neutrolin: Interim analysis of pivotal clinical study
Deferiprone: Commence planning for phase III CIN study
Neutrolin: Submit CE mark application in EU
(all figures in millions) Period Ended:
12/31/107/28/06 (Inception) -
12/31/10
R&D $5.5 $18.0
G&A $3.0 $7.8
Financial Overview
© 2011 CorMedix Inc. 24
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
Company Highlights
• Two products entering late stage clinical development
• Reduced development and regulatory risk
• Worldwide commercialization rights
© 2011 CorMedix Inc.
• Worldwide commercialization rights
• Pipeline of additional products and indications
25