Cormedix LSA Initiation

8/8/2019 Cormedix LSA Initiation

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LIFESCIADVISORS

LIFESCIADVISORS Equity Research Page 1

October 26, 2010

Initiation of Coverage

We are initiating coverage on CorMedix Inc. Our research

describes CorMedixs two lead pipeline candidates, Neutrolin(CRMD003) for the prevention of Catheter-Related Bloodstream Infections slated to enter a Pivotal trial in 1H11 andDeferiprone (CRMD001) for the prevention of ContrastInduced Nephropathy, currently in a phase II trial initiated in2Q10 and Phase III DEFEND-AKI trial projected tocommence in 2H2011.

Andrew I. McDonald, Ph.D.

(415) 205-0591

[email protected] Wallach, Ph.D.

[email protected] Van Buren, M. Sc.

[email protected]

FY Dec 2009A 2010

EPS: Q1 ($1.37)A ($6.40)A

(GAAP) Q2 ($1.42)A ($0.10)A

Q3 NA NA

Q4 NA NA

FY NA NA

Ticker CRMD

Price $1.43

Market Cap (M) $16

EV (M) $6

Shares Outstanding (M) 11.4

Avg. Daily Vol. 7,283

52-week Range: $0.40-$4.00

Cash (M) $10.6

Net Cash/Share $0.93

Debt (M) $0.0

Annualized Cash Burn (M) $6.0

Years of Cash Left 1.8Short Interest (M) 6.42

Short Interest (% ofFloat)

NA

Neutrolin (CRMD003) Pivotal Phase III Trial. CorMedixis planning to initiate a Pivotal trial evaluating Neutrolin as acatheter lock solution for the prevention of Catheter-RelatedBloodstream Infections (CRBIs) in approximately 400 End-

Stage Renal Disease (ESRD) patients. The study will consistof randomized 1:1 patients receiving Neutrolin vs. the activecomparator heparin as a lock solution. The primary endpointsare freedom from CRBI and maintenance of useable catheterlife. The Neutrolin program is expected to be expedited dueto the upcoming submission of an Investigational DeviceExemption (IDE) application and potential approval from theFood and Drug Administration (FDA) expected by the end of1Q2011.

Neutrolin Proof of Concept Data. A feasibility studyevaluating Neutrolin (n=20) (1.35% Taurolidine plus 4%citrate) versus 5000u/ml heparin (n=30) in patientsdemonstrated a very low incidence of CRBIs in the Neutrolinarm when used for a 90 day time period. The study protocolevaluated two main endpoints: the primary endpoint was theoccurrence of CRBIs and the secondary endpoint includedthe need for tPA instillation and/or catheter exchange torestore catheter patency. The study demonstrated that CRBI-free survival at 90 days was significantly higher amongpatients who received Neutrolin when compared to controlpatients who received Heparin (94% vs. 47%; p


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previous statistics translate into 67,500 to 150,000 cases of CRBIs. Of these cases, approximately10% (7,000 to 15,000) of the patients will require hospitalization with serious complicationsincluding severe sepsis or metastatic infections.1 The overall cost for treating CRBIs was estimatedby Allon in 2008 to be $777MM comprised of $466MM and $311MM for inpatient and outpatienttreatments, respectively.2

Deferiprone (CRMD001) Phase II. Deferiprone is an iron chelator being developed for theprevention of Contrast-Induced Nephropathy (CIN) in patients with Chronic Kidney Disease.Deferiprone is currently approved for sale in 50 countries worldwide (excluding the U.S.) for thetreatment of iron overload in patients with Thalassemia Major. The Company is currentlyconducting a phase II trial (started in 2Q2010). The phase II data is expected to be completed priorto the initiation of the phase III trial in 2H2011. The double-blind, randomized, placebo-controlledstudy is estimated to include approximately 60 patients and the primary endpoint is biomarkerevidence of Acute Kidney Injury (AKI) to assess Deferiprones efficacy compared to placebo after 8days of treatment.3

Deferiprone (CRMD001) DEFEND-AKI Phase III trial. The phase III trial of Deferiprone is

anticipated to start in 2H2011 and will include up to 800 patients for the assessment of Deferipronein CIN. The study will consist of patients randomized 1:1 to Deferiprone vs. placebo and will onlyinclude subjects with moderate-severe CKD and other risk factors for CIN. The procedure and thecomposite endpoints will be evaluated during a 90-day period.

Financial Outlook. CorMedix is currently conducting a Phase II clinical trial for CRMD001 andexpects to initiate a pivotal Phase III clinical trial for CRMD003 in 1H011 and does not anticipaterevenues in the near future. CorMedix believes its currently available cash and cash equivalents willbe sufficient to meet its planned clinical development and operating requirements through the endof the first quarter of 2012.

2Q10 Financials. For the six months ended 6/30/10, CorMedix reported no revenue and $4.9MM

in operating expenses, of which, $3.7MM was for R&D related expenses. In the comparable periodin 2009, CorMedix also generated no revenues and $1.3MM of operating expenses (R&D expenseof $0.5MM). The Company generated a net loss of $8.0MM in the first half of 2010 compared to anet loss of $2.3MM in the comparable period in 2009.

2009 Financials. In FY 2009 CorMedix reported no revenue and operating expenses of $6.1 MM,comprised of $4.9MM of R&D expenses and $1.2MM of general and administrative expenses. InJuly 2006, CorMedix was granted from Shiva an exclusive, worldwide license agreement for a patentestate covering proprietary formulations of Deferiprone and a biomarker diagnostic test formeasuring levels of labile iron. Pursuant to this agreement, the Company expensed $3.2MM in 2009.

Cash Position.As of June 30, 2010 CorMedix had $10.6MM of cash and cash equivalents and no

long-term debt. Cash increased $9.1MM in the first half of 2010 to $10.6MM, primarily reflectingproceeds from the public equity offering in March 2010. Specifically, the Companys IPO resulted inthe sale of 1.9 MM units (consisting of two shares of common stock and a warrant to purchase one

LIFESCIADVISORS


1 Am J Kidney Dis 2004;44:779-912Am J Kidney Dis 2008;51:165-83 clinicaltrials.gov, study NCT01146925


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share of common stock) at $6.50/unit, or $3.125 per share and $0.25/warrant. In conjunction withthe IPO, all of CorMedixs outstanding convertible notes were converted into equity.

Expected Upcoming Milestones

Neutrolin (CRMD003) Milestones 4Q 2010: Investigational Device Exemption (IDE) application submission 1H 2011: CE (CE means European Conformity) marketing in Europe (EU) 1H 2011: Initiation of Pivotal trial for prevention of Catheter-Related Bloodstream

Infection (CRBI) in hemodialysis patients 2H 2011: Potential product launching in Europe 1H 2012: Release of preliminary data from Pivotal Phase III clinical trial 2H 2012: File Premarket Approval (PMA) application in the U.S 1H 2013: FDA approval of Neutrolin (CRMD003)

Deferiprone (CRMD001) Milestones

2Q 2010: Deferiprone Phase II: proof-of-concept trial initiated 1H 2011: Phase II data from Deferiprone study 2H 2011: Phase III DEFEND-AKI clinical trial (prevention of Contrast-Induced

Nephropathy in patients with Chronic Kidney Disease) Expected to begin 2H 2012: Release of data from Phase III DEFEND-AKI trial 4Q 2012: File for New Drug Application (NDA) for Deferiprone (CRMD001) 2H 2013: FDA approval of Deferiprone (CRMD001)

Company Description

CorMedix Inc. (CorMedix, CRMD, or the Company) was incorporated on July 28, 2006 in theState of Delaware. In 2007, the Company established its corporate headquarters in Summit, NewJersey. CorMedix is a pharmaceutical company that seeks to develop significant medical therapies forunmet cardiorenal medical needs. CorMedix products target the overlap market of kidney (renal)and cardiac diseases. The Companys two leading products are:

1. Neutrolin (also referred to as CRMD003), which is a drug/device combinationproduct candidate, that serves as a catheter lock solution for the prevention of Catheter-Related Bloodstream Infection (CRBI) and catheter dysfunction.

2. Deferiprone (also referred to as CRMD001), which is a pharmaceutical drugcandidate, used to reduce morbidity and mortality associated with Contrast-InducedNephropathy (CIN) in high-risk Chronic Kidney Disease (CKD) patients undergoing

invasive cardiac procedures (including the injection of iodinated contrast agents).

The Company has a number of products in the pipeline, including CRMD004 and CRMD002.CRMD004, a thixotropic gel, may be used for the prevention of CRBI and maintenance of catheterfunction in hemodialysis patients. CRMD002, another product developed by CorMedix, is abiomarker assay for toxic labile iron in urine samples. Both product candidates are in preclinicalresearch stages. This report focuses on the two lead programs, CRMD001 and CRMD003. Thesetwo products are being developed for the nephrology and cardiovascular markets, and aim to assistin the prevention of CRBI and prevention of CIN and its associated morbidity and mortality.

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Neutrolin (CRMD003): A New Catheter Lock Solution

Neutrolin, one of CorMedixs core product candidates, is being designed as a drug/device forhemodialysis patients with Central Venous Catheters (CVCs). It has completed pilot clinical studiesand is expected to enter a Pivotal trial in 1H11. Neutrolin is designed to be used as the standard of

care in hemodialysis patients who require CVCs. CVCs are permanently implanted in the patientscentral veins allowing vascular access to enable rapid in-flow and out-flow of blood from the patientthrough a dialysis machine in order to filter the blood from harmful wastes, salts and fluids.Approximately 82% of patients initiating hemodialysis treatment in the U.S. in 2006 started using aCVC as the functioning access4. Another vascular access for hemodialysis used regularly is anarteriovenous fistula (AV fistula). AV fistula is the connection of a vein and an artery, usually in theforearm, to allow access to the vascular system for hemodialysis. Although most hemodialysispatients start with CVCs, over 50% will go through the surgical procedure to connect a vein andartery to obtain an AV fistula as their vascular access5. The hemodialysis process is typically initiatedwhen the patients kidneys are functioning at 10-15% capacity. In this therapy, the patients blood isdrawn out of the body into a dialysis machine and filtered prior to returning it back into the body.This therapy requires a lifelong commitment of visiting dialysis centers and hospitals (some patients

have a home dialysis machine), on average 3 times a week for 4 hours per session6

.

Unmet Medical Need: Prevention of CRBIs. The use of CVCs in hemodialysis patients mayresult in two severe complications: Catheter-Related Bloodstream Infection (CRBI) and low bloodflow, due to blood clots within the tubing of the catheter. Approximately 250,000 CVC-associatedCRBIs occur in hospitals each year in the United States according to the Center for Disease Controland Prevention (CDC), of which approximately 160,000 are hemodialysis related. The mean rate ofCVC-related CRBIs in dialysis patients is reported to be 5.0/1,000 catheter days7. CRBI increasesmorbidity and mortality among hemodialysis patients. These mortality and morbidity rates can reach2,400-20,000 deaths per year with estimated hospitalization costs of $296 million to $2.3 billion forCRBI in general8. Hemodialysis-related CRBIs mortality rate is estimated to be 6,000 deaths peryear9. Due to the aforementioned statistics and the increasing number of CVCs used in hospitals,

there is a critical need for the development of preventative strategies to reduce the rate of CRBIs.

Neutrolin Catheter Lock Solution for Prevention of CRBIs. The two main complicationsassociated with CVCs are CRBIs and thrombotic events. Neutrolin was developed as a catheter locksolution to address these major complications by preventing CRBIs and blood clotting within thecatheter. The solution has to be inserted into the two lumens of a CVC at the end of thehemodialysis session in order to reduce the risk for CRBI and catheter thrombosis10. By reducing theinfection risk, the solution can prolong catheter life, as well as reduce the need for local or systemicantibiotic regimens. The Neutrolin solution acts against strains of Methicillin-ResistantStaphylococcus Aureus (MRSA), Methicillin-Resistant Staphylococcus Epidermidis (MRSE) andVancomycin-Resistant Enterococcus (VRE). These infections are common in healthcare facilities(e.g. dialysis centers) due to the compromised immune system of the involved patients. Moreover,

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4 Kidney Int 2009;76:1040-85 Encyclopedia of Surgery6 The American Association of Kidney Patients (AAKP)7 Infez Med 2010;18:79-858 Emerg Infect Dis 2001;7:197-99 CorMedixs Presentation10Clin Infect Dis 2003;36:1539-44


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the Neutrolin catheter lock solution contains an antimicrobial agent, not an antibiotic, which reducesthe risk of promoting bacterial resistance to the commonly used antibiotics.

Currently, physicians insert more than five million CVCs every year to patients beyond thosereceiving hemodialysis. Other Neutrolin-related applications and secondary markets would likelyinclude chemotherapy, chronic antibiotic therapy, total parenteral nutrition and intensive care. Theestimated cost for CRBI treatment is $18,000 per episode as it requires approximately 12 days ofhospitalization.

Mechanism of Action (MOA): Antimicrobial and Anticoagulant Activity. The keycomponents of Neutrolin include: 1.35% Taurolidine (the antimicrobial and antifungal agent), 3.5%citrate and 1000u/ml Heparin (the anticoagulant agent).

The antimicrobial Taurolidine (Chemical Abstracts Service (CAS) number 19388-87-5wassynthesized in the 1970s by Geistlich-Pharma, Inc. Early studies revealed the broad range ofantibacterial and fungal activity that taurolidine possesses. Taurolidine has been used to treat patientswith peritonitis and systemic inflammatory response syndrome due to its anti-endotoxin properties.

Additionally, Taurolidine demonstrates potential anti-tumor properties for the treatment of cancer.It is currently manufactured and approved for use in Europe as an antimicrobial lock solution(Taurolock) which contains Taurolidine (1.35%) for the prevention of CRBIs. The compoundbecomes active when the molecule breaks into active methylol groups during a chemical reaction, which is secondary to the decomposition of the parent molecule as demonstrated in (Figure 1).These methylol groups contain moieties that react with and damage bacterial cell wall componentspreventing adhesion of the affected microorganism to biological surfaces (such as CVC).11 Inaddition to this direct effect on bacterial cell wall components, Taurolidine has been reported toprevent biofilm formation on catheters.12

Figure 1: Chemical Structure of Taurolidine and its Major Breakdown Products

Source:Cancer Res 2001;61:6816-21

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11 Cancer Res 2001;61:6816-2112 J Pediatr Gastroenterol Nutr 2008;47:179-86
http://en.wikipedia.org/wiki/Systemic_inflammatory_response_syndromehttp://en.wikipedia.org/wiki/Systemic_inflammatory_response_syndromehttp://en.wikipedia.org/wiki/Peritonitishttp://en.wikipedia.org/wiki/Peritonitishttp://www.commonchemistry.org/ChemicalDetail.aspx?ref=19388-87-5http://www.commonchemistry.org/ChemicalDetail.aspx?ref=19388-87-5


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CVCs are vital life sustaining devices used in many complex medical situations, includinghemodialysis. Infections remain the most problematic complication associated with CVC devices.CRBI can be caused via different pathways; including the device itself, skin insertion or from adistant septic location.

Studies report that an average of 4-6 infections occur in hemodialysis patients per 1000 catheterdays.13 Since blood clotting provides a risk to hemodialysis patients, the Taurolidine is supplementedwith 3.5% citrate solution and 1,000 u/mL heparin. In addition to the anticoagulant activity, citrateimproves Taurolidines solubility and anti-microbial activity. The current standard of care catheterlock solution is heparin at a concentration of 1000 u/mL. The concentration of heparin has beensignificantly reduced in the past eight years due to a high incidence of bleeding that occurs withhigher concentrations of heparin. The US Food and Drug Administration (FDA) now recommendsa citrate concentration of 5% or less following the death of a patient inadvertently given 43% citratesolution.

Pre-clinical Data. One of the mechanisms in which Neutrolin reduces CRBIs is by preventingbiofilm formation. Biofilms are complex structures containing matrix proteins, extracellular DNA,

and polysaccharides synthesized by bacteria that attach to the surface of hydrated polymericmatrixes such as CVCs. The presence of biofilm on the surface of CVC creates a potential entrywayfor bacteria to penetrate the patients bloodstream. The formation of these attached bacterialcommunities and their inherent resistance to antimicrobial agents promotes many persistent andchronic bacterial infections, particularly CRBIs. Neutrolin is highly effective in reducing biofilmformation; which in turn lowers the incidence of CRBIs. As one can see in Figure 2, Neutrolinblocks very efficiently the growth of biofilm on catheter surfaces when compared to untreated orheparin treated surfaces.14

Figure 2: Scanning Electron Microcopy Images of Biofilm Formation on Catheter SurfacesUsing Different Treatment Methods

Source: Blood Purif 2002;20:87-92and Company Reports

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13 J Pediatr Gastroenterol Nutr 2008;47:179-8614 Blood Purif 2002;20:87-92
http://en.wikipedia.org/wiki/Polysaccharidehttp://en.wikipedia.org/wiki/Polysaccharidehttp://en.wikipedia.org/wiki/DNAhttp://en.wikipedia.org/wiki/DNA


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Neutrolin and Deferiprone, CorMedixs two main product candidates, have untapped potential topenetrate the cardiorenal disease space, particularly patients suffering from Chronic or End StageKidney Disease. Chronic Kidney Disease (CKD) is characterized by the loss of kidney function thatcan deteriorate into a severe condition called End-Stage Renal Disease (ESRD) in which eitherhemodialysis or kidney transplantation is required. ESRD patients are at high risk for CRBIs, whileCKD patients are at high risk of Contrast Induced Nephropathy (CIN) and its complications.CorMedixs product candidates are being designed to address unmet medical needs and help patientsavoid these severe and debilitating complications.

CHRONIC KIDNEY DISEASE BACKGROUND

Chronic Kidney Disease (CKD) is a growing heath concern due to the rise in prevalence of thedisease. According to the National Kidney Foundation, 26 million adults have CKD and millions ofothers are at increased risk. Early detection and prompt treatment can help prevent diseaseprogression and kidney failure. Heart disease is the major cause of death for CKD patients. CKD ischaracterized by damage to the kidneys, which are organs that act as a natural blood filter, removewaste such as urea and ammonium as well as controlling fluid balance by removal of salt and water.

CKD is defined as a persistent reduction in glomerular filtration rate (GFR) to 90 with persistent kidney damage*

2 60-80 with persistent kidney damage*

3 30-59

4 15-29

5


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medication, systemic lupus and genetic syndromes (see Figure 4 for more details). In addition tothese causes, some non-modifiable risk factors are associated with disease progression, whichinclude age, African-American race and male sex.

Figure 4: Potential Causes of CKD

Diagnosis Clinical Indicators

Diabetes mellitusClassical clinical course of microoalbuminuria, followed by clinical proteinuria,

hypertension and then declining GFR

HypertensionUsually characterized by severely elevated blood pressure readings over a long

period with associated end-organ damage in the addition to kidney diseaseNephrotoxicmedications

Review prescribed and over-the-counter medications as well as intravenous contrastdye or gadolinium exposure

Systemic lupuserythematosus

Evaluate for photosensitivity, malar/discoid rashes, oral ulcers, arthritis, serositis,neurological symptoms, hematological findings, ANA/dsDNA positive

HIV nephropathy Signs and symptoms of immunodeficiency; HIV positive on testing

Congestive heartfailure

Signs and symptoms of heart failure present. Because fluid overload is common inchronic kidney disease, diagnosis is made through echocardiogram to evaluate

systolic and diastolic heart function

Genetic syndrome Evaluation of family history is suggestive

Hepatorenal syndromeHistory of evidence of cirrhosis with resultant portal hypertension, ascites, and

renal vasoconstriction. Classically lack significant proteinuria

NephrolithiasisEvaluate for history of hematuria and symptoms of renal colic. Long standing

obstruction can cause permanent renal impairmentBenign prostatic

hypertrophyEvaluate male patients for hesitancy, straining, or weak flow during urination and

nocturia, confirm with prostate exam

GlomerulonephritisBroad category of disease including postinfectious (streptococcal) as well as various

vasculitisdisease. Urinalysis suggestive with presence of red blood cell castsGFR, glomerular filtration r

human immunodeficiency vi

te, ANA, antinuclear antibodies; dsDNA, double stranded deoxyribonucleic acid; HIV,

rus

Source: Am Board Fam Med 2010;23:542-50

CKD Symptoms and Treatment. Symptoms might not appear in the early stages of the disease;however some may experience weakness and exhaustion, trouble concentrating and sleeping, musclecramping and swollen feet and ankle and frequent urination. Treatment for CKD focuses on slowingthe progression of the kidney damage, usually by controlling the underlying cause. In order to haltdisease progression, the following modifiable risks should be under close monitoring: higher levelsof proteinuria, lower serum albumin levels, high blood pressure, poor glycemic control and smoking.

Proteinuria detection and control is crucial for slowing disease progression and kidney damage;therefore, screening random samples of urine for quantification of the ratio of protein-creatinineused in the identification of proteinuria, is essential. In the case of proteinuria, AngiotensinConverting Enzyme (ACE) inhibitors should be applied as first line medication. AngiotensinReceptor Blocker (ARB) is another medication used in combination or as an alternative for ACE.15

Blood pressure control is important in the care of CKD patients. ACE inhibitors and ARB are alsoused as a medication for hypertension. However, in most cases, additional medications such asdiuretics are needed as well. The National Kidney Foundation suggests a blood pressure goal of 30 countries Leading the global launch of Calstrux Directing a global team

Prior to Stryker Biotech, John worked for Aventis (and predecessor companies) for more than 14years. Highlights include:

Leading the global launch of Nasacort ($100M+ brand) Serving as commercial lead on the Aventis-Millennium inflammation collaboration

Serving as Global New Products Commercialization Head for Respiratory, Inflammation,Cardiovascular and Metabolism Leading the commercial business development outside of core therapeutic areas

Mark T. Houser, M.D., MBA. Chief Medical Officer

As an experienced academic and clinical Nephrologist, with a strong clinical research, basic science,and management background, Mark has a unique skill set that well suits CorMedix's cardiorenalaspirations.During his tenure at Johnson & Johnson (OrthoBiotech) Mark had diverse responsibilities including:

Leading clinical development projects in oncology and critical care Leading business development projects primarily focused on cardiorenal projects; 50+

projects accessed Internal nephrology consultant to the J&J family of companies including OCD, OBI,

Cordis, Ethicon, Veridex, Centocor, J&J PRD Regional medical affairs management for Procrit

As a clinical and academic Nephrologist, his achievements include: Clinical Medical Director of a large dialysis network Basic research in the areas of oxidative stress in acute and chronic renal injury

He recently completed an MBA, majoring in marketing and management

Brian Lenz, CPA, MBA. Chief Financial Officer

Brian has over 15 years of financial and operational experience in addition to significant capitalraising, merger and acquisition and other strategic activities. Prior to joining CorMedix, Brian wasthe Chief Financial Officer and Treasurer at Arno Therapeutics and prior to that served the sameroles at VioQuest Pharmaceuticals, Inc.

Prior to VioQuest, Brian was the controller of Smiths Detection Group where he was responsiblefor corporate and operational financial reporting and consolidation of its international operations, in

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addition to being responsible for the information technology and human resources functions. Brianstarted his career as a senior auditor with KPMG, LLP. Brian is a certified public accountant licensedin the state of New Jersey, and a member of the CFO advisory committee of BIONJ.

Risk to an Investment

The outcomes of pivotal clinical trials for both Neutrolin and Deferiprone would affectCRMD shareholders. Both Neutrolin and Deferiprone are going through major clinical trials thatare inherently risky and hard to predict their outcomes. The near-term major value proposition ofCRMD shareholders is the continued success of Neutrolin in Phase III clinical studies for catheter-related bacterial infection and Deferiprone in Phase II and Phase III clinical studies for CIN.Operating expenses over the next several years require capital for research, development, pre-clinicaltesting and clinical trial that can impact shareholder value.

Lack of finance could impede corporate development. As the Company is currently notgenerating revenues, there is a need for sufficient financial support from either the financial marketor non-dilutive sources in order to maintain development of the pipeline products. As a result of

limited operating history of CorMedix and net deficit due to early development stage Shareholder value could be impaired. In addition, future equity offerings could dilute the value of existingshareholders. The company incurred significant operating and capital expenditures in the past fewyears and anticipates an increase in expenditures due to expensive clinical trials in the foreseeablefuture.

The company did not apply for sales regulatory approvals for the CorMedix products. NewDrug Application (NDA) was submitted and approved recently for Deferiprone however approval isneeded for both products before they can be placed on the market. Approval or delays can diluteshareholder value. Additionally, sales potential can be impaired by competitors.

Successful commercialization can be impaired by competitive disadvantages. Although there

are currently no approved products as catheter lock solution on the market, multiple companies arein stages of developing catheter blocks solution for the prevention of blood stream infections. It ishard to predict the sale value of the product or its competitors and whether the company canproperly market the products to obtain revenues.

After commercialization risks include physicians, hospital and patients usage of the newproducts. Even if the FDA approves one or more of the company product candidates, physicians,hospitals and even patients themselves might not accept and use the product. The prediction of howthe product will do on the market are hard and dependent on many components includingphysicians familiarity and choice to use the new product, cost effectiveness of the product relative toits competitor on the market, reimbursement from the government and healthcare payers andeffectiveness of the company in marketing the new product.

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DISCLOSURES

The material presented in this report is provided for information purposes only and is not to be used or considered as arecommendation to buy, hold or sell any securities or other financial instruments. Information contained herein has beencompiled by LifeSci Advisors and prepared from various public and industry sources that we believe to be reliable, but

no representation or warranty, expressed or implied is made by LifeSci Advisors, its affiliates or any other person as tothe accuracy or completeness of the information. Such information is provided with the expectation that it will be read

as part of a broader analysis and should not be relied upon on a stand-alone basis. Past performance should not be takenas an indication or guarantee of future performance, and we make no representation or warranty regarding future

performance. The opinions expressed in this report reflect the judgment of LifeSci Advisors as of the date of thisreport and are subject to change without notice. This report is not an offer to sell or a solicitation of an offer to buy anysecurities. The offer and sale of securities are regulated generally in various jurisdictions, particularly the manner in

which securities may be offered and sold to residents of a particular country or jurisdiction. Securities discussed in thisreport may not be eligible for sale in some jurisdictions. To the full extent provided by law, neither LifeSci Advisors nor

any of its affiliates, nor any other person accepts any liability whatsoever for any direct or consequential loss arising fromany use of this report or the information contained herein. No LifeSci Advisors directors, officers or employees are on

the Board of Directors of a covered company and no one at a covered company is on the Board of Directors of LifeSciAdvisors. Neither the analyst who authored this report nor any of LifeSci Advisors directors, officers, employees investin the securities of the company that is the subject of this report. LifeSci Advisors has been compensated by the

company that is the subject of this report for this and future research reports, investor relations services, and general

consulting services.

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Cormedix LSA Initiation