This report provides a buy rating and $5 price target for CorMedix Inc. (CRMD) stock. Key points include:
1) CRMD expects to report final phase II trial results for its drug Deferiprone in preventing contrast-induced kidney injury by Q4 2011, which could be a significant catalyst if positive.
2) CRMD is on track to start a pivotal trial for its Neutrolin product in preventing catheter-related blood infections in mid-2011 and potentially launch in Europe in 2012.
3) At current prices, the analyst believes CRMD remains undervalued given the potential of its pipeline products.
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Cormedix ($CRMD) - Maxim June 2011 Update
1. EQUITY RESEARCH
COMPANY REPORT
Biotechnology CorMedix Inc. Buy
June 14, 2011 (CRMD – AMEX – $1.60)
Closing Price (6/13/11): $1.60
12-Month Target Price: $5.00
One execution milestone completed and Deferiprone in CIN
52-Week Range: $1.08-$2.50
M arket Cap (MM): $18
Phase II trial results expected in 4Q11; Reiterate Buy rating
Shares O/S (MM): 11.4 and $5 price target
Float (MM ): 10.1
Shares Short (000): 8.2 What’s new? This morning, CorMedix announced completion of
Avg. Vol. (000) 11.0
patient enrollment for Deferiprone (CRMD001) in contrast-induced
Book Value/Share: $0.47 acute kidney injury (CIN) Phase II study and expects to report the
Dividend/Yield: $0.00/0.00% final results in 4Q11.
Risk Profile: Speculative Top-line Deferiprone (CRMD001) in CIN prevention Phase II
Maxim Group Quarterly Revenue ($M) trial results by the year end, if positive, would be a substantial
FYE: December 2010A 2011E upside. The ongoing Phase II trial is double blind, placebo-
1Q $0.0 $0.0 A controlled randomized 60-patoemt study that evaluates the safety
2Q $0.0 $0.0 and efficacy of Deferiprone (CRMD001) on biomarkers of acute
3Q $0.0 $0.0 kidney injury and kidney functions in CKD patients with high risk
4Q $0.0 $0.0 of undergoing a coronary angiography and receiving an iodinated
FY $0.0 $0.0 radio-contrast agent. Management anticipates reporting top-line
Maxim Group Current Current results potentially by 4Q11 followed by a go/no go decision shortly
FYE: December EPS P/E after. In our opinion, a positive outcome would be a major catalyst
2009A: GAAP ($9.48) NM for CRMD share value appreciation given that this would be the
2010A: GAAP ($1.15) NM first clinical proof-of- concept study for Deferiprone as well as the
2011E: GAAP ($0.79) NM success of Neutrolin (CRMD001) so far has accounted for the
2012E: GAAP ($1.08) NM majority of current CRMD share value, in our opinion.
LT Earnings Growth NA Neutrolin (CRMD001) developments remain on-track. CRMD
Quarterly GAAP EPS has submitted an investigational device exemption (IDE)
Maxim Group Current Current application to the FDA and is scheduled to commence a pivotal trial
FYE: December 2010A 2011E for Neutrolin in CRBI possibly in mid-11. It has filed for CE mark
1Q ($6.40) ($0.17 A) in Europe for Neutrolin as a prevention of catheter-related
2Q ($0.10) ($0.20) bloodstream infection (CRBI), but due to a workload backup by the
3Q ($0.12) ($0.23) EMEA, potential approval and launch has been push out to 1H12.
4Q ($0.16) ($0.19) CRMD is also in discussions with prospective partners for the
FY ($1.15) ($0.79) commercialization of Neutrolin in Europe and we anticipate
Consensus-First Call Quarterly EPS potentially more activities in 2H11 and beyond.
FYE: December 2010A 2011E Reiterate Buy rating and 12-month target price of $5. With the
1Q ($6.40) ($0.17 A) company’s: 1) lead product Neutrolin expected to start a Phase III
2Q ($0.10) ($0.20) study in 1H11 in the U.S. and to potentially generate revenue from
3Q ($0.12) ($0.23) Europe in 2012; 2) potential positive Deferiprone Phase II study,
4Q ($0.16) ($0.19) which could add substantial value; and 3) low visibility to the
FY ($1.15) ($0.79) investment community, CRMD shares remain undervalued, in our
opinion. As such, we reiterate our Buy recommendation for CRMD,
Yale Jen, Ph.D. (212) 895-3516 with a 12-month target price of $5.00 based on comparable analysis
yjen@maximgrp.com of enterprise value against a peer group of Phase II biotech
companies.
Maxim Group LLC - 405 Lexington Avenue - New York, NY 10174 - www.maximgrp.com
SEE PAGES 4 - 6 FOR IMPORTANT DISCLOSURES AND DISCLAIMERS
2. CorMedix Inc. (CRMD)
Expected milestones for 2011 and beyond
Program Indication Event Timing
Commence pivotal trial 2Q11
Potentially receive CE mark approval in EU 1H12
Potential EU partnership 2H11 / 2012
Prevention of catheter related
Neutrolin (CRMD003)
bactermia (CRB)
Potential product launch in EU 1H12
Potential FDA decision on Zuragen PMA 2011
Potential release interim results of pivotal trial Early '12
Release complete results from biomarker Phase II proof-of-
4Q11
concept study
Contrast Induced Nephropathy (CIN) Potential making go/no go decision 4Q11
Deferiprone (CRMD001)
Potential initiate Phase III study with SPA designation 2012
Potentially commence of proof of concept trial in high risk CKD
Chronic Kidney Disease (CKD) 2012
patients
Source: Company reports and Maxim Group estimates
Maxim Group LLC 2
3. CorMedix Inc. (CRMD)
CorMedix, Inc. Annual Income Statement
(IN MILLIONS, EXCEPT PER SHARE AMOUNTS)
($ 000s)
2009 2010 2011E 2012E 2013E
1Q11 2Q11E 3Q11E 4Q11E
Revenue
Revenue - - - - - - - 1,000 17,676
Others (upfront, milestone, etc.) - - - - - - - - -
Total revenue - - - - - - - 1,000 17,676
COGS 3,535
Research and development 4,889 5,494 1,176 1,516 1,789 2,290 6,772 16,523 19,497
General and administrative 1,167 3,013 834 885 920 948 3,586 3,766 19,846
Total Operating Expenses 6,055 8,507 2,010 2,401 2,709 3,238 10,358 20,289 42,878
Operating income (losses) (6,055) (8,507) (2,010) (2,401) (2,709) (3,238) (10,358) (19,289) (25,203)
Other income 30 27 24 22 103 103 103
Interest income 2 415 5 5 5 5 21 21 21
Interest expense, including amortization of deferred financin (2,068) (3,094) - - - - - - -
Total other income (expense) (2,066) (2,679) 35 32 29 27 123 123 123
Net income (loss) before tax (8,121) (11,186) (1,975) (2,369) (2,680) (3,211) (10,235) (19,166) (25,080)
Tax 281 -
Net income (loss) (8,121) (10,905) (1,975) (2,369) (2,680) (3,211) (10,235) (19,166) (25,080)
Basic and diluted net income (loss) per share (9.48) (1.15) (0.17) (0.20) (0.23) (0.19) (0.79) (1.08) (1.27)
Shares outstanding—basic & diluted 857 9,473 11,408 11,608 11,808 17,208 13,008 17,708 19,775
Margin Analysis (% of Total operating expenses)
COGS 0% 0% 0% 0% 0% 0% 0% 0% 20%
R&D 81% 65% 58% 63% 66% 71% 65% 81% 45%
G&A 19% 35% 42% 37% 34% 29% 35% 19% 46%
Operating Income (loss) 100% 100% 100% 100% 100% 100% 100% 100% 100%
Financial Indicator Growth Analysis (YoY%)
Revenue NA NA NA NA NA NA NA NA 1668%
Total revenue NA NA NA NA NA NA NA NA 1668%
COGS NA NA NA NA NA NA NA NA NA
Research and development 59% 12% -62% 170% 135% 113% 23% 144% 18%
General and administrative -33% 158% 29% 43% 43% -14% 19% 5% 427%
Total Operating Expenses 26% 40% -46% 104% 93% 48% 22% 96% 111%
Interest income -92% 19365% 18350% -9% -50% -99% -95% 0% 0%
Interest expense, including amortization of deferred financing co -51% 50% -100% NA NA NA -100% -5% 7%
Net income (loss) -10% 34% -71% 102% 92% 114% -6% 87% 31%
Basic and diluted net income (loss) per share -13% -88% -97% 99% 86% 19% -32% 38% 17%
SOURCE: MAXIM GROUP LLC RESEARCH AND SEC FILING
Maxim Group LLC 3
4. CorMedix Inc. (CRMD)
DISCLOSURES
Source: Investars
Maxim Group LLC Stock Rating System As of: 6/14/2011
% 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 67.1% 23.5%
Hold Expected total return of plus or minus 14% over next 12 months 25.0% 0.0%
Sell Expected total negative return of at least 15% over next 12 months 7.9% 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 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.
Maxim Group LLC 4
5. CorMedix Inc. (CRMD)
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
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.
Maxim Group LLC 5
6. CorMedix Inc. (CRMD)
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