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.
Cardiorenal disease includes a broad range of inter-related cardiovascular, kidney and metabolic problems which share the common trait of underlying oxidative stress and blood vessel malfunction (endothelial dysfunction).
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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
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