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DRIVES EVERYTHING WE DO
Forward Looking Statements
This presentation contains certain statements that constitute forward-looking statements
within 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 looking
statements in this presentation include statements about our business, including
commercialization plans and potential markets for our products and product candidates,
clinical trials, potential indications for our product candidates, development timelines,
regulatory timelines and future events that have not yet occurred. Pharmaceutical and
medical device development inherently involves 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 Commission on March 27, 2013 and in "Risk Factors"
in our Quarterly Reports on Form 10-Q filed with the Securities and Exchange
Commission on May 15 and August 14, 2013. Our actual results may differ materially
from our expectations due to these risks and uncertainties, including, but not limited to,
our dependence on the success of our lead product candidate, and factors relating to
commercialization and regulatory approval thereof, ability to raise sufficient capital,
retaining our stock's listing on the NYSE MKT, research and development activities,
intellectual property protection, competition, industry environment, and other matters.
Any forward-looking statements included in this presentation are based on information
available to us on the date of this presentation. We undertake no obligation to update or
revise any forward-looking statement, whether as a result of new information, future
events or otherwise.
Investment Highlights
CorMedix (NYSE MKT: CRMD) develops and markets
products to treat renal, cardiac and infectious diseases
Lead product Neutrolin
Class III CE Mark approved (drug-device) in July 2013
Catheter-related bloodstream infections (CRBSI)
cost approx. $25,000-40,000/hospitalization, or $6+ B/year, in the US
Clear European commercialization strategy
specialized and highly experienced EU sales force
Using a catheter lock solution (CLS) such as Neutrolin can reduce
occurrence of CRBSI by as much as 60-90 percent
$500M worldwide market potential
Solid Global IP portfolio
17 issued U.S. patents
Catheter Safety and Efficacy:
Total CRBSI cost to the
U.S. healthcare system
Sources: U.S. Centers for Disease Control and Prevention. Trish Perl, M.D., professor, medicine and pathology, Johns Hopkins School
of Public Health, Baltimore; Eyal Zimlichman, M.D., research associate, The Center for Patient Safety, Brigham and Women's Hospital,
Boston; Sept. 2, 2013, JAMA Internal Medicine, online
What could save the US Healthcare system
A Catheter Lock Solution (CLS)
that fills the catheter to:
Significantly decrease CRBSI
Decrease catheter blood clotting
Taurolidine, an anti-infective
Citrate, a buffering compound
Heparin, an anticoagulant
Taurolidine: a taurine amino acid
Shows broad antibacterial action
against gram-positive and gram-
negative bacteria, mycobacteria and
some clinically relevant fungi
Shows a higher affinity than
mannose (the natural substrate) for
bacterial fimbriae protein responsible
for bacterial adhesion to human cells
Source: Caruso F, Darnowski JW, Opazo C, Goldberg A, Kishore N, et al. (2010) Taurolidine Antiadhesive Properties on Interaction with E. coli; Its
Transformation in Biological Environment and Interaction with Bacteria Cell Wall. PLoS ONE 5(1): e8927. doi:10.1371/journal.pone.0008927
Why is Antimicrobial Resistance a Problem?
Antibiotic/antimicrobial resistant infections cause:
- greater risk of death
- higher treatment costs
A high percentage of hospital-acquired infections are
caused by highly resistant microorganisms
- Dialysis patients with catheters are susceptible to biofilm, which
nurtures and protects bacterial and fungal cell growth
- Neutrolin controls bacteria growth in biofilm
Source: World Health Organization
Taurolidine-Based Catheter Lock Solution:
Demonstrated Effectiveness
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, 4. Bisseling, T. M., M. C. Willems, et al. (2010)
Clin Nutr 29(4): 464-8 , 5.Al-Amin, A. H., J. Sarveswaran, et al. (2013). J Vasc Access 0(0): 0., 6.Chu, H. P., J. Brind, et al. (2012). J Pediatr Gastroenterol Nutr 55(4): 403-7, 7Handrup, M. M.,
J. K. Moller, et al. (2013). Pediatr Blood Cancer 60(8): 1292-8
Successful EU Launch for Hemodialysis
Label Expansion in EU
Rollout to Other Key Countries
Neutrolin Growth Strategy
Entry into US Market for Hemodialysis
Initial Neutrolin Indication:
Possible expanded Indications:
Oncology, ICU, Parenteral Nutrition, Peritoneal Dialysis
Successful EU Launch for Hemodialysis
Successful launch in Germany and Austria
- Experienced sales team
- Increase healthcare provider awareness
- Sales being booked: not yet shipped
Negotiate partner arrangements
Position Neutrolin strategically
- Understand payer reimbursement policies
Rollout to Other Key Countries
Identify best sales partners in
Monitor product positioning
and coordinate manufacturing
Entry Into US Market