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

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.

1. © 2011 CorMedix Inc.
1
Company Overview
April 2011
NYSE Amex: CRMD www.cormedix.com

2. Forward Looking Statements
This presentation contains certain statements that consti
tute forward-looking statements
within the meaning of the federal securities laws. Statemen
ts that are not historical facts,
including statements about our beliefs and expectations, a
re forward-looking statements.
These statements are not guarantees of future performance a
nd involve risks,
uncertainties and assumptions that are difficult to predic
t. The forward looking
statements in this presentation include statements about o
ur business, including results
of clinical trials, potential indications for our product c
andidates, development timelines
and
future
events
that
have
not
yet
occurred
.
Pharmaceutical
development
inherently
© 2011 CorMedix Inc.
2
and
future
events
that
have
not
yet
occurred
.
Pharmaceutical
development
inherently
involves significant risks and uncertainties, including t
he risks outlined in “Risk Factors”
in our Annual Report on Form 10-K filed with the Securities an
dExchangeCommission
on March 11
th
,2011. Ouractualresultsmaydiffermateriallyfromourexp
ectations due
to these risks and uncertainties, including our dependence
on the success of our lead
product candidates, and factors relating to regulatory app
roval, research and
development, intellectual property protection, competit
ion, industry environment, ability
to raise sufficient capital and other matters. Any forward-
looking statements included in
this presentation are based on information available to us o
nthedateofthis
presentation. We undertake no obligation to update or revis
eanyforward-looking
statement, whether as a result of new information, future ev
ents or otherwise.

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
© 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

4. Company Highlights •
Two products entering late stage clinical developme
nt
–
Neutrolin
for the prevention of catheter related bloodstream inf
ection
(CRBI) and maintenance of catheter patency in hemodial
ysis (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; Appro
ved
regulatory path (SPA) with FDA
•
Worldwide commercialization rights
•
Pipeline of additional products and indications
4

5. Product Pipeline
INDICATION
PRODUCT
PRECLINICAL
PILOT
PIVOTAL
Neutrolin (
CRMD003
)
Prevention of CRBI*
Thixotropic Gel
(CRMD004)
Prevention of CRBI
© 2011 CorMedix Inc.
INDICATION
PRODUCT
PRECLINICAL
PHASE I
PHASE II
PHASE III
Urine Catalytic Iron Test
(CRMD002)
Deferiprone (CRMD001)Deferiprone (CRMD001)
Diagnostic TestTreatment of CKDPrevention of CIN
5
*
CRBI – Catheter Related Bloodstream Infection

6. Neutrolin
© 2011 CorMedix Inc.
6

7. •
80,000 HD catheter patients in the U.S., representi
ng 12.5 million
HD sessions per year
•
CVCs are subject to clotting and can result in cath
eter related
bloodstream infection (CRBI)
Central Venous Catheter Therapeutic Market in Hemod
ialysis
© 2011 CorMedix Inc.
•
160,000 CRBI episodes in the U.S. alone
1
, 6,000 dieannually
•
Cost to US healthcare system could approach $1 bill
ion annually
2
•
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
7

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
© 2011 CorMedix Inc.
–
>14,000 patients exposed to taurolidine
–
No systemic toxicity at levels 400x the amount contained i
n 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 stu
dies
8

9. 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 Puri
f 2002; 20: 87-92
Biofilm on Intravenous Catheter
Biofilm with microbial colonization completely covers surface
No biofilm or microbial colonization
9

10. Neutrolin Pilot Study Completed
Neutrolin
456
CRBI events per 1000 days
CRBI at 90 days was lower among patients who receiv
ed Neutrolin than among
control patients who received heparin
© 2011 CorMedix Inc.
Adapted from: Allon M, Clin Infect Dis 2003; 36:153
9-1544.
P < .001
____ Neutrolin ------- heparinheparin
P < .02
0123
Pre Neutrolin Post
CRBI events per 1000 days
10

11. Neutrolin Demonstrated Effectiveness
Study Number of patients
Average duration
(days)
Control group
Neutrolin
% patients without
infection
1
20 pts Neutrolin
30 pts heparin
85
heparin
5000 u/mL
case-control
94
© 2011 CorMedix Inc.
2
58 158
heparin
5000 u/mL
100
3
76 250 none 96
1. Allon M
Clin Infect Dis
(2003) 36 (12):1539-44
2. Betjes
N
ephrol Dial Transplant
(2004) 19:1546-1551
3. Sodemann K et al
Poster: ASN 2001
11

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)
© 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
12

13. Neutrolin Commercial Plan
•
Initial U.S. launch by CorMedix for HD patients wit
h CVC
–
Establish Neutrolin as standard of care
–
Seek inclusion in renal guidelines and dialysis providers p
olicy & procedure
protocols
–
Seek quality of care endorsements for improvement in per
formance 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 preve
ntative medicine, non-
payment for hospital acquired infection
•
Apply for CE mark and commence commercial launch pl
anning in EU
•
Apply for additional indications for non-HD CVCs an
d PICC lines
13

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 derivat
ive, a biologically
acceptable acid and low concentration heparin
© 2011 CorMedix Inc.
acceptable acid and low concentration heparin
•
Additional filings under prosecution to extend prot
ection
14

15. Deferiprone
© 2011 CorMedix Inc.
15

16. Contrast Induced Nephropathy (CIN) Market Overview
•
Cardiac interventions use X-ray and iodinated contr
ast dye to
visualize coronary vessels
•
In “high risk” patients undergoing PCI* with Chroni
c Kidney Disease,
the dye can cause acute kidney damage – otherwise kn
own as CIN
•
CIN is the 3
rd
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
16
*
PCI – Percutaneous Coronary Intervention

17. 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 iron
1
4.05.06.07.0
Baseline 48 hours after IVP
P
<0.001
+115%
nmol / mg Cr
© 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-det
ectable) iron following radiocontrast exposure in
healthy kidney donors ASN 2006
0.01.02.03.0
Urinary catalytic iron
nmol / mg Cr
17

18. •
Deferiprone launched in 1999, available in >50 Ex-U
S countries for
the treatment of Thalassemia Major
•
Deferiprone efficacy and safety is well characteriz
ed – 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 benefi
t of extended
release formulations – less nausea/vomiting
•
Compared to other iron chelators, deferiprone is:
–
Superior at penetrating cells and sub-cellular compartme
nts
1
–
Selectively binding catalytic iron
1
Glickstein et al. Blood 108: 3195, 2006
18

19. Deferiprone Competitive Landscape
Attribute
Deferiprone
CRMD001
Deferiprone Ferriprox
(1)
Desferasirox
Exjade
(2)
Deferoxamine
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
© 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

20. Deferiprone Development Plan
Regulatory •
Complete a small biomarker Phase II proof of concep
t trial
•
Commence planning for Phase III CIN study pending P
hase 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 includ
e: cystatin C,
NGAL, LFABP
•
Secondary endpoints: clinical outcomes and persiste
nt changes in
kidney function
20

21. •
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 ne
w product
launches due to morbidity/mortality claim and absen
ce of alternative
therapies
21

22. Deferiprone IP Overview
•
Specific CIN patent under prosecution
•
Anticipate Hatch Waxman 5 year marketing exclusivit
y if gain first
approval of deferiprone in U.S.
•
8 issued patents for treating progressive kidney di
sease
© 2011 CorMedix Inc.
•
8 issued patents for treating progressive kidney di
sease
•
Additional filings under prosecution
22

23. 
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
TIMING TIMING
ACHIEVEMENTS & MILESTONES ACHIEVEMENTS & MILESTONES
2010 1H 2011
Achievements & Anticipated Milestones
© 2011 CorMedix Inc.

Deferiprone:
Interim
analysis of phase
II CIN
study
1H 2011
23
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 stud
y

Deferiprone: Commence planning for phase III CIN stu
dy

Neutrolin: Submit CE mark application in EU

24. (all figures in millions)
Period Ended:
12/31/10
7/28/06 (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

25. Company Highlights •
Two products entering late stage clinical developme
nt
•
Reduced development and regulatory risk
•
Worldwide commercialization rights
© 2011 CorMedix Inc.
•
Worldwide commercialization rights
•
Pipeline of additional products and indications
25