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Maxim Group LLC - 405 Lexington Avenue - New York, NY 10174 - www.maximgrp.com
SEE PAGES 6 - 8 FOR IMPORTANT DISCLOSURES AND DISCLAIMERS
EQUITY RESEARCH
COMPANY REPORT
Biotechnology
Closing Price (3/17/10): $1.84
12-Month Target Price: $5.00
52-Week Range: $0.40-$4.00
Market Cap (MM): $21
Shares O/S (MM): 11.4
Float (MM): 10.9
Shares Short (000): 6.1
Avg. Vol. (000) 18.2
Book Value/Share: $0.77
Dividend/Yield: $0.00/0.00%
Risk Profile: Speculative
Maxim Group
FYE: December 2010A 2011E
1Q $0.0 $0.0
2Q $0.0 $0.0
3Q $0.0 $0.0
4Q $0.0 $0.0
FY $0.0 $0.0
Maxim Group Current Prior Current
FYE: December EPS EPS P/E
2009A: GAAP ($9.48) NM
2010A: GAAP ($1.15) NM
2011E: GAAP ($0.58) ($0.70) NM
2012E: GAAP ($0.43) NM
LT Earnings Growth NA
Maxim Group Current Prior Current
FYE: December 2010A 2010E 2011E
1Q ($6.40) ($0.13)
2Q ($0.10) ($0.15)
3Q ($0.12) ($0.17)
4Q ($0.16) ($0.09) ($0.14)
FY ($1.15) ($6.72) ($0.58)
Consensus-First Call
FYE: December 2010A 2011E
1Q ($6.40) --
2Q ($0.10) --
3Q ($0.12) --
4Q ($0.16) --
FY ($1.15) ($0.70)
Yale Jen, Ph.D. (212) 895-3516
yjen@maximgrp.com
Quarterly Revenue ($M)
Quarterly EPS
March 18, 2011
Quarterly GAAP EPS
CorMedix Inc. Buy
(CRMD – AMEX – $1.84)
4Q10 results; Waiting for Deferiprone’s interim results from
the Phase II trial in in CIN and Neutrolin CE mark CRB
approval; Increasing financial estimates; Reiterate Buy
rating and $5 price target
4Q10 financial results. CRMD reported a 4Q10 net loss of
$1.5MM or ($0.16) per share, compared to both our estimate and
the Street consensus estimate of a $1.1MM loss or ($0.09) per
share. CRMD ended 4Q10 with cash and cash equivalents of
approximately $9.3MM, which we believe is sufficient for its
operations into 1Q12.
Interim results from the Deferiprone (CRMD001) Phase II trial
in CIN prevention are expected in 1Q11. Management indicated
that the release of Deferiprone’s interim results in the contrast-
induced nephropathy (CIN) prevention Phase II study are slated for
1Q11, with complete results potentially available in 2H11. In our
opinion, a positive outcome from the study would be a major
catalyst for CRMD shareholder value.
Neutrolin (CRMD001) development update. The company has
started the process of filing for CE mark in Europe for Neutrolin as
a prevention of catheter-related bloodstream infection (CRBI), with
potential approval in 2H11. CRMD is also in active discussions
with prospective partners for the commercialization of Neutrolin in
Europe. If approved, the company could generate revenue from
Europe starting in late 2011 or early 2012. The company has also
submitted an investigational device exemption (IDE) application to
the FDA for the commencement of a pivotal trial for Neutrolin in
CRBI, possibly in 1H11. As a reminder, several earlier clinical
studies demonstrated that Neutrolin without heparin exhibited
antimicrobial activities vs. the current standard of care, and the
addition of heparin boosted the anticoagulation activities of
Neutrolin – the scenario should bode well for the success of the
upcoming Neutrolin Phase III study for CRBI prevention, in our
opinion.
Reiterate Buy rating and 12-month target price of $5. With the
company’s: 1 lead product Neutrolin expected to start a Phase III
study in 1H11 in the U.S. and to potentially generate revenue from
Europe in late 2011; 2) Deferiprone undergoing a Phase II study,
with interim data expected in 1Q11; and 3) low visibility to the
investment community, CRMD shares remain undervalued, in our
opinion. As such, we reiterate our Buy recommendation for CRMD
to risk-tolerant, long-term investors, with a 12-month target price of
$5.00 based on a comparable analysis.
CorMedix Inc. (CRMD)
Maxim Group LLC 2
DETAILS
Interim results from the Deferiprone (CRMD0010) Phase II trial in CIN prevention are
expected in 1Q11. Our discussion with management suggests that interim results from the
Deferiprone Phase II study in contrast-induced nephropathy (CIN) prevention (mainly biomarker
analysis with n=30) are expected in 1Q11 and complete results (n=60) will potentially be reported in
2H11. Given Deferiprone’s established iron-chelating capability and the logical rationale that excess
labile iron is a major pathological cause of CIN, we believe the outcome from the upcoming Phase II
biomarker study, if positive, could provide a substantial clinical proof-of-concept and increase this
asset’s value. Should outcomes be positive, the company could start a pivotal study with a SPA
designation in 2012. The company could also potentially consider commencing a proof-of-concept
trial that evaluates Deferiprone in high-risk chronic kidney disease (CKD) patients if the Phase II
outcome is positive.
Neutrolin developments in the U.S. and European updates. The company recently filed for an
investigational device exemption (IDE) application to FDA and a CE market application to EMEA for
Neutrolin as a prevention of catheter-related bacteremia (CRB). According to this timeline, we believe
the company might commence a pivotal Phase III trial in the U.S. in 1H11, with potential interim
results expected in late 2011 or early 2012 and potential approval in 2013. Given that several earlier
clinical studies exhibited antimicrobial activities vs. the current standard of care (heparin), and the
addition of heparin boosted the anticoagulation activities of Neutrolin, we believe this could bode well
for the success of the upcoming Neutrolin in CRB prevention Phase III study. Given that there is
limited news regarding a potential FDA decision on Zuragen PMA, we believe the competitive
landscape might not be as steep as anticipated in the U.S.
In addition, the company could potentially receive CE mark approval in Europe in 2H11 and
potentially launch the product in Europe soon afterward, in our opinion. Management is
contemplating several commercialization models for the potential sale of Neutrolin in Europe and is in
active discussions with prospective partners. As such, we believe the company could generate
revenue from Neutrolin in Europe starting in late 2011 or 2012.
Financials
During 4Q10, CRMD’s net loss was $1.5MM, or ($0.16) per share, below our estimate of a $1.1MM
loss or ($0.09) per share and the consensus of a $1.1MM loss or ($0.09) per share. By the end of
December 2010, the company had cash and cash equivalents of $9.3MM.
($ MM) Maxim Estimate Actual Consensus
Total revenue $0 $0 $0
Total op. profit ($1.1) ($2.2) ($1.1)
R&D $0.9 $1.1 -
SG&A $0.7 $1.1 -
EPS (GAAP & dil) ($0.09) ($0.16) ($0.09)
Net income ($1.1) ($1.5) ($1.1)
Table 1: 4Q10 Estimates and Reported Results
Revenues
Although we do not model any revenue in 2011, it is possibly that the company could generate
revenue from a successful partnership and launch of Neutrolin in Europe.
CorMedix Inc. (CRMD)
Maxim Group LLC 3
Operating Expenses
Research and development costs for 4Q10 were $1.1MM, higher than our $0.9MM estimate.
Based on our discussions with management, we have adjusted our R&D expense estimate for
2011 to $5.2MM, from $6.6MM, and are providing a 2012 R&D estimate of $5.9MM, reflecting
the adjusted clinical developments.
SG&A expenses for 4Q10 were $1.1MM, higher than our estimate of $0.7MM. As a result, we
have adjusted our SG&A expense estimates in 2011 to $3.2MM, from $2.8MM, and are providing
a 2012 SG&A expense estimate of $3.4MM, respectively.
Net Income and EPS
Net loss for 4Q10 was $1.5MM, more than our $1.1MM net loss estimate and consensus’
$1.1MM estimate. Loss per diluted share for 4Q10 was ($0.16), worse than our net loss estimate
of ($0.09) and consensus’ ($0.09) estimate. As a result, we have revised our 2011 net loss
estimate to $7.6MM, from $9.4 MM, and are providing our 2012 net loss estimate of $7.5MM.
Our revised 2011 loss per share estimates adjusts to ($0.58), versus our prior estimate of ($0.70),
and we are providing our 2012 loss per share estimate of ($0.43).
CorMedix Inc. (CRMD)
Maxim Group LLC 4
Expected milestones for 2011 and beyond
Program Indication Event Timing
Potentially receive CE mark approval in EU 2H11
Commence pivotal trial 1H11
Potential EU partnership 2011
Potential product launch in EU 2H11
Potential FDA decision on Zuragen PMA 2011
Potential release interim results of pivotal trial Late '11 / '12
Interim results from biomarker Phase II proof-of-concept study 1Q11
Complete results from biomarker Phase II proof-of-concept
study
2H11
Potential initiate Phase III study with SPA designation 2012
Chronic Kidney Disease (CKD)
Potentially commence of proof of concept trial in high risk CKD
patients
2012
Neutrolin (CRMD003)
Prevention of catheter related
bactermia (CRB)
Contrast Induced Nephropathy (CIN)
Deferiprone (CRMD001)
Source: Company reports and Maxim Group estimates
CorMedix Inc. (CRMD)
Maxim Group LLC 5
CorMedix, Inc. Annual Income Statement
(IN MILLIONS, EXCEPT PER SHARE AMOUNTS)
($ 000s)
1Q10 2Q10 3Q10 4Q10 1Q11E 2Q11E 3Q11E 4Q11E
Revenue
Revenue - - - - - - - - - - - 1,000 23,231
Others (upfront, milestone, etc.) - - - - - - - - - - - - -
Total revenue - - - - - - - - - - - 1,000 23,231
COGS 4,646
Research and development 4,889 3,097 561 761 1,076 5,494 969 1,163 1,372 1,701 5,204 5,933 7,001
General and administrative 1,167 647 618 642 1,106 3,013 752 797 829 854 3,232 3,393 17,883
Total Operating Expenses 6,055 3,744 1,178 1,403 2,182 8,507 1,721 1,960 2,201 2,555 8,436 9,326 29,530
Operating income (losses) (6,055) (3,744) (1,178) (1,403) (2,182) (8,507) (1,721) (1,960) (2,201) (2,555) (8,436) (8,326) (6,299)
Interest income 2 0 6 10 399 415 200 200 200 200 800 800 800
Interest expense, including amortization of deferred financing (2,068) (3,094) - (3,094) - - - - - - -
Total other income (expense) (2,066) (3,094) 6 10 399 (2,679) 200 200 200 200 800 800 800
Net income (loss) before tax (8,121) (6,837) (1,173) (1,392) (1,784) (11,186) (1,521) (1,760) (2,001) (2,355) (7,636) (7,526) (5,499)
Tax 281 281 -
Net income (loss) (8,121) (6,837) (1,173) (1,392) (1,503) (10,905) (1,521) (1,760) (2,001) (2,355) (7,636) (7,526) (5,499)
Basic and diluted net income (loss) per share (9.48) (6.40) (0.10) (0.12) (0.16) (1.15) (0.13) (0.15) (0.17) (0.14) (0.58) (0.43) (0.28)
Shares outstanding—basic & diluted 857 1,068 11,408 11,408 11,410 9,473 11,610 11,810 12,010 17,410 13,210 17,610 19,677
Margin Analysis (% of Total operating expenses)
COGS 0% 0% 0% 0% 0% 0% 0% 0% 0% 0% 0% 0% 20%
R&D 81% 83% 48% 54% 49% 65% 56% 59% 62% 67% 62% 64% 24%
G&A 19% 17% 52% 46% 51% 35% 44% 41% 38% 33% 38% 36% 61%
Operating Income (loss) 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100%
Financial Indicator Growth Analysis (YoY%)
Revenue NA NA NA NA NA NA NA NA NA NA NA NA 2223%
Total revenue NA NA NA NA NA NA NA NA NA NA NA NA 2223%
COGS NA NA NA NA NA NA NA NA NA NA NA NA NA
Research and development 59% 963% -44% 62% -72% 12% -69% 107% 80% 58% -5% 14% 18%
General and administrative -33% 89% -43% 87% 1346% 158% 16% 29% 29% -23% 7% 5% 427%
Total Operating Expenses 26% 492% -43% 72% -45% 40% -54% 66% 57% 17% -1% 11% 217%
Interest income -92% -95% 170% 49305% 1532685% 19365% 714186% 3419% 1828% -50% 93% 0% 0%
Interest expense, including amortization of deferred financing co -51% 450% -100% -100% -100% 50% -100% NA NA NA -100% -5% 7%
Net income (loss) -10% 472% -67% 13% -67% 34% -78% 50% 44% 57% -30% -1% -27%
Basic and diluted net income (loss) per share -13% 369% -93% -92% -97% -88% -98% 45% 36% -13% -50% -26% -35%
2013E
'09-'13E
CAGR
2009 2010 2011E 2012E
SOURCE: MAXIM GROUP LLC RESEARCH AND SEC FILING
CorMedix Inc. (CRMD)
Maxim Group LLC 6
DISCLOSURES
Source: Investars
As of: 3/18/2011
% of Coverage % of Ratings
Universe that Firm received
Expected Performance* with Rating Banking fees
Buy Expected total return of 15% or more over next 12 months 65.1% 23.2%
Hold Expected total return of plus or minus 14% over next 12 months 30.2% 0.0%
Sell Expected total negative return of at least 15% over next 12 months 4.7% 0.0%
* Relative to Nasdaq Composite.
An Under Review (UR) rating represents a stock that the Firm has temporarily placed under review due to a material change.
Maxim Group LLC Stock Rating System
Maxim makes a market in CorMedix, Inc.
Maxim Group has received compensation for investment banking services from CorMedix, Inc. in
the past 12 months.
Maxim Group expects to receive or intends to seek compensation for investment banking services
from CorMedix, Inc. in the next 3 months.
Maxim Group has managed or co-managed a public offering of CorMedix, Inc. in the past 12
months.
I, Yale Jen, attest that the views expressed in this research report accurately reflect my personal views
about the subject security and issuer. Furthermore, no part of my compensation was, is, or will be directly
or indirectly related to the specific recommendation or views expressed in this research report.
The research analyst(s) primarily responsible for the preparation of this research report have received
compensation based upon various factors, including the firm’s total revenues, a portion of which is
generated by investment banking activities.
Valuation Methods: One or more of the following valuation methods are used by Maxim Group
analysts in making a ratings or price projection: Analysis of companies’ P/E ratio, price/book ratio,
earnings expectations or sales growth as they relate within an industry group or to the broader market,
enterprise value/sales, individual sector analysis, sum of the parts analysis and discounted cash flow.
Price Target Risks: Investment risks associated with the achievement of the price target include, but are
not limited to, the company’s failure to achieve our earnings and revenue estimates, unforeseen
CorMedix Inc. (CRMD)
Maxim Group LLC 7
macroeconomic and/or industry events that adversely impact demand for the company’s products and
services, product obsolescence, the company’s ability to recruit and retain competent personnel, changes
in investor sentiment regarding the specific company or industry, changing competitive pressures and
adverse market conditions. For a complete discussion of the risk factors that could affect the market price
of the company’s shares, refer to the most recent form 10-Q or 10-K that the company has filed with the
SEC.
Investment Risks: Aside from general market and other economic risks, risks particular to our
CorMedix Inc. rating include: 1) the success of pivotal clinical trials for both Neutrolin and Deferiprone
would have major impact for CRMD shareholders; 2) sales potential for the two products could be
different significantly from expected; 3) lack of cash could impede corporate development; and 4) thinly
traded stock limits shareholder options.
RISK RATINGS
Risk ratings take into account both fundamental criteria and price volatility.
Speculative –
Fundamental Criteria: This is a risk rating assigned to early-stage companies with minimal to no
revenues, lack of earnings, balance sheet concerns, and/or a short operating history. Accordingly,
fundamental risk is expected to be significantly above the industry.
Price Volatility: Because of the inherent fundamental criteria of the companies falling within this risk
category, the price volatility is expected to be significant with the possibility that the investment could
eventually be worthless.
Speculative stocks may not be suitable for a significant class of individual investors.
High –
Fundamental Criteria: This is a risk rating assigned to companies having below-average revenue and
earnings visibility, negative cash flow, and low market cap or public float. Accordingly, fundamental risk
is expected to be above the industry.
Price volatility: The price volatility of companies falling within this category is expected to be above the
industry.
High-risk stocks may not be suitable for a significant class of individual investors.
Medium –
Fundamental Criteria: This is a risk rating assigned to companies that may have average revenue and
earnings visibility, positive cash flow, and is fairly liquid.
Accordingly, both price volatility and fundamental risk are expected to approximate the industry average.
Low –
Fundamental Criteria: This is a risk rating assigned to companies that may have above-average revenue
and earnings visibility, positive cash flow, and is fairly liquid.
Accordingly, both price volatility and fundamental risk are expected to be below the industry.
DISCLAIMERS
CorMedix Inc. (CRMD)
Maxim Group LLC 8
Some companies that Maxim Group LLC follows are emerging growth companies whose securities
typically involve a higher degree of risk and more volatility than the securities of more established
companies. The securities discussed in Maxim Group LLC research reports may not be suitable for some
investors. Investors must make their own determination as to the appropriateness of an investment in any
securities referred to herein, based on their specific investment objectives, financial status and risk
tolerance.
This communication is neither an offer to sell nor a solicitation of an offer to buy any securities
mentioned herein. This publication is confidential for the information of the addressee only and may not
be reproduced in whole or in part, copies circulated, or disclosed to another party, without the prior
written consent of Maxim Group, LLC (“Maxim”).
Information and opinions presented in this report have been obtained or derived from sources believed by
Maxim to be reliable, but Maxim makes no representation as to their accuracy or completeness. Maxim
accepts no liability for loss arising from the use of the material presented in this report, except that this
exclusion of liability does not apply to the extent that such liability arises under specific statutes or
regulations applicable to Maxim. This report is not to be relied upon in substitution for the exercise of
independent judgment. Maxim may have issued, and may in the future issue, other reports that are
inconsistent with, and reach different conclusions from, the information presented in this report. Those
reports reflect the different assumptions, views and analytical methods of the analysts who prepared them
and Maxim is under no obligation to ensure that such other reports are brought to the attention of any
recipient of this report.
Past performance should not be taken as an indication or guarantee of future performance, and no
representation or warranty, express or implied, is made regarding future performance. Information,
opinions and estimates contained in this report reflect a judgment at its original date of publication by
Maxim and are subject to change without notice. The price, value of and income from any of the
securities mentioned in this report can fall as well as rise. The value of securities is subject to exchange
rate fluctuation that may have a positive or adverse effect on the price or income of such securities.
Investors in securities such as ADRs, the values of which are influenced by currency volatility, effectively
assume this risk. Securities recommended, offered or sold by Maxim: (1) are not insured by the Federal
Deposit Insurance Company; (2) are not deposits or other obligations of any insured depository
institution; and (2) are subject to investment risks, including the possible loss of principal invested.
Indeed, in the case of some investments, the potential losses may exceed the amount of initial investment
and, in such circumstances; you may be required to pay more money to support these losses.
ADDITIONAL INFORMATION IS AVAILABLE UPON REQUEST

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Maxim March 2011 Report on Cormedix ($CRMD)

  • 1. Maxim Group LLC - 405 Lexington Avenue - New York, NY 10174 - www.maximgrp.com SEE PAGES 6 - 8 FOR IMPORTANT DISCLOSURES AND DISCLAIMERS EQUITY RESEARCH COMPANY REPORT Biotechnology Closing Price (3/17/10): $1.84 12-Month Target Price: $5.00 52-Week Range: $0.40-$4.00 Market Cap (MM): $21 Shares O/S (MM): 11.4 Float (MM): 10.9 Shares Short (000): 6.1 Avg. Vol. (000) 18.2 Book Value/Share: $0.77 Dividend/Yield: $0.00/0.00% Risk Profile: Speculative Maxim Group FYE: December 2010A 2011E 1Q $0.0 $0.0 2Q $0.0 $0.0 3Q $0.0 $0.0 4Q $0.0 $0.0 FY $0.0 $0.0 Maxim Group Current Prior Current FYE: December EPS EPS P/E 2009A: GAAP ($9.48) NM 2010A: GAAP ($1.15) NM 2011E: GAAP ($0.58) ($0.70) NM 2012E: GAAP ($0.43) NM LT Earnings Growth NA Maxim Group Current Prior Current FYE: December 2010A 2010E 2011E 1Q ($6.40) ($0.13) 2Q ($0.10) ($0.15) 3Q ($0.12) ($0.17) 4Q ($0.16) ($0.09) ($0.14) FY ($1.15) ($6.72) ($0.58) Consensus-First Call FYE: December 2010A 2011E 1Q ($6.40) -- 2Q ($0.10) -- 3Q ($0.12) -- 4Q ($0.16) -- FY ($1.15) ($0.70) Yale Jen, Ph.D. (212) 895-3516 yjen@maximgrp.com Quarterly Revenue ($M) Quarterly EPS March 18, 2011 Quarterly GAAP EPS CorMedix Inc. Buy (CRMD – AMEX – $1.84) 4Q10 results; Waiting for Deferiprone’s interim results from the Phase II trial in in CIN and Neutrolin CE mark CRB approval; Increasing financial estimates; Reiterate Buy rating and $5 price target 4Q10 financial results. CRMD reported a 4Q10 net loss of $1.5MM or ($0.16) per share, compared to both our estimate and the Street consensus estimate of a $1.1MM loss or ($0.09) per share. CRMD ended 4Q10 with cash and cash equivalents of approximately $9.3MM, which we believe is sufficient for its operations into 1Q12. Interim results from the Deferiprone (CRMD001) Phase II trial in CIN prevention are expected in 1Q11. Management indicated that the release of Deferiprone’s interim results in the contrast- induced nephropathy (CIN) prevention Phase II study are slated for 1Q11, with complete results potentially available in 2H11. In our opinion, a positive outcome from the study would be a major catalyst for CRMD shareholder value. Neutrolin (CRMD001) development update. The company has started the process of filing for CE mark in Europe for Neutrolin as a prevention of catheter-related bloodstream infection (CRBI), with potential approval in 2H11. CRMD is also in active discussions with prospective partners for the commercialization of Neutrolin in Europe. If approved, the company could generate revenue from Europe starting in late 2011 or early 2012. The company has also submitted an investigational device exemption (IDE) application to the FDA for the commencement of a pivotal trial for Neutrolin in CRBI, possibly in 1H11. As a reminder, several earlier clinical studies demonstrated that Neutrolin without heparin exhibited antimicrobial activities vs. the current standard of care, and the addition of heparin boosted the anticoagulation activities of Neutrolin – the scenario should bode well for the success of the upcoming Neutrolin Phase III study for CRBI prevention, in our opinion. Reiterate Buy rating and 12-month target price of $5. With the company’s: 1 lead product Neutrolin expected to start a Phase III study in 1H11 in the U.S. and to potentially generate revenue from Europe in late 2011; 2) Deferiprone undergoing a Phase II study, with interim data expected in 1Q11; and 3) low visibility to the investment community, CRMD shares remain undervalued, in our opinion. As such, we reiterate our Buy recommendation for CRMD to risk-tolerant, long-term investors, with a 12-month target price of $5.00 based on a comparable analysis.
  • 2. CorMedix Inc. (CRMD) Maxim Group LLC 2 DETAILS Interim results from the Deferiprone (CRMD0010) Phase II trial in CIN prevention are expected in 1Q11. Our discussion with management suggests that interim results from the Deferiprone Phase II study in contrast-induced nephropathy (CIN) prevention (mainly biomarker analysis with n=30) are expected in 1Q11 and complete results (n=60) will potentially be reported in 2H11. Given Deferiprone’s established iron-chelating capability and the logical rationale that excess labile iron is a major pathological cause of CIN, we believe the outcome from the upcoming Phase II biomarker study, if positive, could provide a substantial clinical proof-of-concept and increase this asset’s value. Should outcomes be positive, the company could start a pivotal study with a SPA designation in 2012. The company could also potentially consider commencing a proof-of-concept trial that evaluates Deferiprone in high-risk chronic kidney disease (CKD) patients if the Phase II outcome is positive. Neutrolin developments in the U.S. and European updates. The company recently filed for an investigational device exemption (IDE) application to FDA and a CE market application to EMEA for Neutrolin as a prevention of catheter-related bacteremia (CRB). According to this timeline, we believe the company might commence a pivotal Phase III trial in the U.S. in 1H11, with potential interim results expected in late 2011 or early 2012 and potential approval in 2013. Given that several earlier clinical studies exhibited antimicrobial activities vs. the current standard of care (heparin), and the addition of heparin boosted the anticoagulation activities of Neutrolin, we believe this could bode well for the success of the upcoming Neutrolin in CRB prevention Phase III study. Given that there is limited news regarding a potential FDA decision on Zuragen PMA, we believe the competitive landscape might not be as steep as anticipated in the U.S. In addition, the company could potentially receive CE mark approval in Europe in 2H11 and potentially launch the product in Europe soon afterward, in our opinion. Management is contemplating several commercialization models for the potential sale of Neutrolin in Europe and is in active discussions with prospective partners. As such, we believe the company could generate revenue from Neutrolin in Europe starting in late 2011 or 2012. Financials During 4Q10, CRMD’s net loss was $1.5MM, or ($0.16) per share, below our estimate of a $1.1MM loss or ($0.09) per share and the consensus of a $1.1MM loss or ($0.09) per share. By the end of December 2010, the company had cash and cash equivalents of $9.3MM. ($ MM) Maxim Estimate Actual Consensus Total revenue $0 $0 $0 Total op. profit ($1.1) ($2.2) ($1.1) R&D $0.9 $1.1 - SG&A $0.7 $1.1 - EPS (GAAP & dil) ($0.09) ($0.16) ($0.09) Net income ($1.1) ($1.5) ($1.1) Table 1: 4Q10 Estimates and Reported Results Revenues Although we do not model any revenue in 2011, it is possibly that the company could generate revenue from a successful partnership and launch of Neutrolin in Europe.
  • 3. CorMedix Inc. (CRMD) Maxim Group LLC 3 Operating Expenses Research and development costs for 4Q10 were $1.1MM, higher than our $0.9MM estimate. Based on our discussions with management, we have adjusted our R&D expense estimate for 2011 to $5.2MM, from $6.6MM, and are providing a 2012 R&D estimate of $5.9MM, reflecting the adjusted clinical developments. SG&A expenses for 4Q10 were $1.1MM, higher than our estimate of $0.7MM. As a result, we have adjusted our SG&A expense estimates in 2011 to $3.2MM, from $2.8MM, and are providing a 2012 SG&A expense estimate of $3.4MM, respectively. Net Income and EPS Net loss for 4Q10 was $1.5MM, more than our $1.1MM net loss estimate and consensus’ $1.1MM estimate. Loss per diluted share for 4Q10 was ($0.16), worse than our net loss estimate of ($0.09) and consensus’ ($0.09) estimate. As a result, we have revised our 2011 net loss estimate to $7.6MM, from $9.4 MM, and are providing our 2012 net loss estimate of $7.5MM. Our revised 2011 loss per share estimates adjusts to ($0.58), versus our prior estimate of ($0.70), and we are providing our 2012 loss per share estimate of ($0.43).
  • 4. CorMedix Inc. (CRMD) Maxim Group LLC 4 Expected milestones for 2011 and beyond Program Indication Event Timing Potentially receive CE mark approval in EU 2H11 Commence pivotal trial 1H11 Potential EU partnership 2011 Potential product launch in EU 2H11 Potential FDA decision on Zuragen PMA 2011 Potential release interim results of pivotal trial Late '11 / '12 Interim results from biomarker Phase II proof-of-concept study 1Q11 Complete results from biomarker Phase II proof-of-concept study 2H11 Potential initiate Phase III study with SPA designation 2012 Chronic Kidney Disease (CKD) Potentially commence of proof of concept trial in high risk CKD patients 2012 Neutrolin (CRMD003) Prevention of catheter related bactermia (CRB) Contrast Induced Nephropathy (CIN) Deferiprone (CRMD001) Source: Company reports and Maxim Group estimates
  • 5. CorMedix Inc. (CRMD) Maxim Group LLC 5 CorMedix, Inc. Annual Income Statement (IN MILLIONS, EXCEPT PER SHARE AMOUNTS) ($ 000s) 1Q10 2Q10 3Q10 4Q10 1Q11E 2Q11E 3Q11E 4Q11E Revenue Revenue - - - - - - - - - - - 1,000 23,231 Others (upfront, milestone, etc.) - - - - - - - - - - - - - Total revenue - - - - - - - - - - - 1,000 23,231 COGS 4,646 Research and development 4,889 3,097 561 761 1,076 5,494 969 1,163 1,372 1,701 5,204 5,933 7,001 General and administrative 1,167 647 618 642 1,106 3,013 752 797 829 854 3,232 3,393 17,883 Total Operating Expenses 6,055 3,744 1,178 1,403 2,182 8,507 1,721 1,960 2,201 2,555 8,436 9,326 29,530 Operating income (losses) (6,055) (3,744) (1,178) (1,403) (2,182) (8,507) (1,721) (1,960) (2,201) (2,555) (8,436) (8,326) (6,299) Interest income 2 0 6 10 399 415 200 200 200 200 800 800 800 Interest expense, including amortization of deferred financing (2,068) (3,094) - (3,094) - - - - - - - Total other income (expense) (2,066) (3,094) 6 10 399 (2,679) 200 200 200 200 800 800 800 Net income (loss) before tax (8,121) (6,837) (1,173) (1,392) (1,784) (11,186) (1,521) (1,760) (2,001) (2,355) (7,636) (7,526) (5,499) Tax 281 281 - Net income (loss) (8,121) (6,837) (1,173) (1,392) (1,503) (10,905) (1,521) (1,760) (2,001) (2,355) (7,636) (7,526) (5,499) Basic and diluted net income (loss) per share (9.48) (6.40) (0.10) (0.12) (0.16) (1.15) (0.13) (0.15) (0.17) (0.14) (0.58) (0.43) (0.28) Shares outstanding—basic & diluted 857 1,068 11,408 11,408 11,410 9,473 11,610 11,810 12,010 17,410 13,210 17,610 19,677 Margin Analysis (% of Total operating expenses) COGS 0% 0% 0% 0% 0% 0% 0% 0% 0% 0% 0% 0% 20% R&D 81% 83% 48% 54% 49% 65% 56% 59% 62% 67% 62% 64% 24% G&A 19% 17% 52% 46% 51% 35% 44% 41% 38% 33% 38% 36% 61% Operating Income (loss) 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% Financial Indicator Growth Analysis (YoY%) Revenue NA NA NA NA NA NA NA NA NA NA NA NA 2223% Total revenue NA NA NA NA NA NA NA NA NA NA NA NA 2223% COGS NA NA NA NA NA NA NA NA NA NA NA NA NA Research and development 59% 963% -44% 62% -72% 12% -69% 107% 80% 58% -5% 14% 18% General and administrative -33% 89% -43% 87% 1346% 158% 16% 29% 29% -23% 7% 5% 427% Total Operating Expenses 26% 492% -43% 72% -45% 40% -54% 66% 57% 17% -1% 11% 217% Interest income -92% -95% 170% 49305% 1532685% 19365% 714186% 3419% 1828% -50% 93% 0% 0% Interest expense, including amortization of deferred financing co -51% 450% -100% -100% -100% 50% -100% NA NA NA -100% -5% 7% Net income (loss) -10% 472% -67% 13% -67% 34% -78% 50% 44% 57% -30% -1% -27% Basic and diluted net income (loss) per share -13% 369% -93% -92% -97% -88% -98% 45% 36% -13% -50% -26% -35% 2013E '09-'13E CAGR 2009 2010 2011E 2012E SOURCE: MAXIM GROUP LLC RESEARCH AND SEC FILING
  • 6. CorMedix Inc. (CRMD) Maxim Group LLC 6 DISCLOSURES Source: Investars As of: 3/18/2011 % of Coverage % of Ratings Universe that Firm received Expected Performance* with Rating Banking fees Buy Expected total return of 15% or more over next 12 months 65.1% 23.2% Hold Expected total return of plus or minus 14% over next 12 months 30.2% 0.0% Sell Expected total negative return of at least 15% over next 12 months 4.7% 0.0% * Relative to Nasdaq Composite. An Under Review (UR) rating represents a stock that the Firm has temporarily placed under review due to a material change. Maxim Group LLC Stock Rating System Maxim makes a market in CorMedix, Inc. Maxim Group has received compensation for investment banking services from CorMedix, Inc. in the past 12 months. Maxim Group expects to receive or intends to seek compensation for investment banking services from CorMedix, Inc. in the next 3 months. Maxim Group has managed or co-managed a public offering of CorMedix, Inc. in the past 12 months. I, Yale Jen, attest that the views expressed in this research report accurately reflect my personal views about the subject security and issuer. Furthermore, no part of my compensation was, is, or will be directly or indirectly related to the specific recommendation or views expressed in this research report. The research analyst(s) primarily responsible for the preparation of this research report have received compensation based upon various factors, including the firm’s total revenues, a portion of which is generated by investment banking activities. Valuation Methods: One or more of the following valuation methods are used by Maxim Group analysts in making a ratings or price projection: Analysis of companies’ P/E ratio, price/book ratio, earnings expectations or sales growth as they relate within an industry group or to the broader market, enterprise value/sales, individual sector analysis, sum of the parts analysis and discounted cash flow. Price Target Risks: Investment risks associated with the achievement of the price target include, but are not limited to, the company’s failure to achieve our earnings and revenue estimates, unforeseen
  • 7. CorMedix Inc. (CRMD) Maxim Group LLC 7 macroeconomic and/or industry events that adversely impact demand for the company’s products and services, product obsolescence, the company’s ability to recruit and retain competent personnel, changes in investor sentiment regarding the specific company or industry, changing competitive pressures and adverse market conditions. For a complete discussion of the risk factors that could affect the market price of the company’s shares, refer to the most recent form 10-Q or 10-K that the company has filed with the SEC. Investment Risks: Aside from general market and other economic risks, risks particular to our CorMedix Inc. rating include: 1) the success of pivotal clinical trials for both Neutrolin and Deferiprone would have major impact for CRMD shareholders; 2) sales potential for the two products could be different significantly from expected; 3) lack of cash could impede corporate development; and 4) thinly traded stock limits shareholder options. RISK RATINGS Risk ratings take into account both fundamental criteria and price volatility. Speculative – Fundamental Criteria: This is a risk rating assigned to early-stage companies with minimal to no revenues, lack of earnings, balance sheet concerns, and/or a short operating history. Accordingly, fundamental risk is expected to be significantly above the industry. Price Volatility: Because of the inherent fundamental criteria of the companies falling within this risk category, the price volatility is expected to be significant with the possibility that the investment could eventually be worthless. Speculative stocks may not be suitable for a significant class of individual investors. High – Fundamental Criteria: This is a risk rating assigned to companies having below-average revenue and earnings visibility, negative cash flow, and low market cap or public float. Accordingly, fundamental risk is expected to be above the industry. Price volatility: The price volatility of companies falling within this category is expected to be above the industry. High-risk stocks may not be suitable for a significant class of individual investors. Medium – Fundamental Criteria: This is a risk rating assigned to companies that may have average revenue and earnings visibility, positive cash flow, and is fairly liquid. Accordingly, both price volatility and fundamental risk are expected to approximate the industry average. Low – Fundamental Criteria: This is a risk rating assigned to companies that may have above-average revenue and earnings visibility, positive cash flow, and is fairly liquid. Accordingly, both price volatility and fundamental risk are expected to be below the industry. DISCLAIMERS
  • 8. CorMedix Inc. (CRMD) Maxim Group LLC 8 Some companies that Maxim Group LLC follows are emerging growth companies whose securities typically involve a higher degree of risk and more volatility than the securities of more established companies. The securities discussed in Maxim Group LLC research reports may not be suitable for some investors. Investors must make their own determination as to the appropriateness of an investment in any securities referred to herein, based on their specific investment objectives, financial status and risk tolerance. This communication is neither an offer to sell nor a solicitation of an offer to buy any securities mentioned herein. This publication is confidential for the information of the addressee only and may not be reproduced in whole or in part, copies circulated, or disclosed to another party, without the prior written consent of Maxim Group, LLC (“Maxim”). Information and opinions presented in this report have been obtained or derived from sources believed by Maxim to be reliable, but Maxim makes no representation as to their accuracy or completeness. Maxim accepts no liability for loss arising from the use of the material presented in this report, except that this exclusion of liability does not apply to the extent that such liability arises under specific statutes or regulations applicable to Maxim. This report is not to be relied upon in substitution for the exercise of independent judgment. Maxim may have issued, and may in the future issue, other reports that are inconsistent with, and reach different conclusions from, the information presented in this report. Those reports reflect the different assumptions, views and analytical methods of the analysts who prepared them and Maxim is under no obligation to ensure that such other reports are brought to the attention of any recipient of this report. Past performance should not be taken as an indication or guarantee of future performance, and no representation or warranty, express or implied, is made regarding future performance. Information, opinions and estimates contained in this report reflect a judgment at its original date of publication by Maxim and are subject to change without notice. The price, value of and income from any of the securities mentioned in this report can fall as well as rise. The value of securities is subject to exchange rate fluctuation that may have a positive or adverse effect on the price or income of such securities. Investors in securities such as ADRs, the values of which are influenced by currency volatility, effectively assume this risk. Securities recommended, offered or sold by Maxim: (1) are not insured by the Federal Deposit Insurance Company; (2) are not deposits or other obligations of any insured depository institution; and (2) are subject to investment risks, including the possible loss of principal invested. Indeed, in the case of some investments, the potential losses may exceed the amount of initial investment and, in such circumstances; you may be required to pay more money to support these losses. ADDITIONAL INFORMATION IS AVAILABLE UPON REQUEST