CorMedix Inc. - Quarter Report: 2010 September (Form 10-Q)
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
FORM
10-Q
(Mark
One)
ý
|
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
|
For the
quarterly period ended September 30,
2010
¨
|
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
|
For the
transition period from ________ to ________
Commission
file number 001-34673
CORMEDIX
INC.
|
|
(Exact Name of Registrant as
Specified in Its Charter)
|
|
Delaware
|
20-5894890
|
(State or Other Jurisdiction of
Incorporation or Organization)
|
(I.R.S. Employer Identification
No.)
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745
Rt. 202-206, Suite
303,
Bridgewater,
NJ
|
08807
|
(Address of Principal Executive
Offices)
|
(Zip
Code)
|
(908)
517-9500
|
|
(Registrant’s Telephone Number, Including Area
Code)
|
|
_____________________________________________
|
|
(Former Name, Former Address and
Former Fiscal Year, if Changed Since Last
Report)
|
Indicate
by check mark whether the registrant: (1) has filed all reports required to be
filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the
preceding 12 months (or for such shorter period that the registrant was required
to file such reports), and (2) has been subject to such filing requirements for
the past 90 days. Yes ý No
¨
Indicate
by check mark whether the registrant has submitted electronically and posted on
its corporate Web site, if any, every Interactive Data File required to be
submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this
chapter) during the preceding 12 months (or for such shorter period that the
registrant was required to submit and post such
files). Yes ¨ No
¨
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer, or a smaller reporting
company. See the definitions of “large accelerated filer,”
“accelerated filer” and “smaller reporting company” in Rule 12b-2 of the
Exchange Act. (Check one):
Large accelerated
filer ¨
|
Accelerated
filer ¨
|
|
Non-accelerated
filer ¨
|
Smaller reporting
company ý
|
|
(Do not check if a smaller
reporting company)
|
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act). Yes ¨ No
ý
The
number of shares outstanding of the issuer’s common stock, as of November 8,
2010 was 11,408,288.
CORMEDIX
INC.
INDEX
PART
I FINANCIAL INFORMATION
|
1
|
|
Item
1.
|
Financial
Statements
|
1
|
Condensed
Balance Sheets (Unaudited) September 30, 2010 and December 31,
2009
|
1
|
|
Condensed
Statements of Operations (Unaudited) for the Three and Nine Months Ended
September 30, 2010 and 2009 and for the Cumulative Period From July 28,
2006 (Inception) Through September 30, 2010
|
2
|
|
Condensed
Statement of Changes in Stockholders’ Equity (Deficiency) (Unaudited) for
the Nine Months Ended September 30, 2010
|
3
|
|
Condensed
Statements of Cash Flows (Unaudited) for the Nine Months Ended September
30, 2010 and 2009 and for the Cumulative Period From July 28, 2006
(Inception) Through September 30, 2010
|
4
|
|
Notes
to Condensed Financial Statements (Unaudited)
|
5
|
|
Item
2.
|
Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
|
12
|
Item
3.
|
Quantitative
and Qualitative Disclosures About Market Risk
|
19
|
Item
4.
|
Controls
and Procedures
|
19
|
PART
II OTHER INFORMATION
|
20
|
|
Item
1.
|
Legal
Proceedings
|
20
|
Item
1A.
|
Risk
Factors
|
20
|
Item
2.
|
Unregistered
Sales of Equity Securities and Use of Proceeds
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20
|
Item
3.
|
Defaults
Upon Senior Securities
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20
|
Item
4.
|
(Removed
and Reserved)
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20
|
Item
5.
|
Other
Information
|
20
|
Item
6.
|
Exhibits
|
20
|
SIGNATURES
|
22
|
i
PART
I
FINANCIAL
INFORMATION
Item
1.
|
Financial
Statements.
|
CORMEDIX
INC.
(A
Development Stage Company)
CONDENSED
BALANCE SHEETS
September
30, 2010
(Unaudited)
|
December
31, 2009
(Note
1)
|
|||||||
ASSETS
|
||||||||
Current
assets
|
||||||||
Cash and cash
equivalents
|
$ | 9,522,241 | $ | 1,505,179 | ||||
Prepaid research and development
expenses
|
77,421 | 175,000 | ||||||
Other prepaid expenses and current
assets
|
94,101 | 3,114 | ||||||
Total current
assets
|
9,693,763 | 1,683,293 | ||||||
Property and equipment,
net
|
25,708 | 24,116 | ||||||
Deferred financing fees,
net
|
- | 506,510 | ||||||
Security
deposit
|
13,342 | 11,733 | ||||||
TOTAL
ASSETS
|
$ | 9,732,813 | $ | 2,225,652 | ||||
LIABILITIES AND
STOCKHOLDERS’ EQUITY (DEFICIENCY)
|
||||||||
Current
liabilities
|
||||||||
Accounts payable
|
$ | 517,122 | $ | 549,638 | ||||
Accrued
expenses
|
420,808 | 75,000 | ||||||
Senior convertible notes, net of
discount
|
- | 12,229,897 | ||||||
Interest payable – senior
convertible notes
|
- | 2,393,132 | ||||||
Notes payable – related
parties
|
- | 535,428 | ||||||
Interest payable – related
parties
|
- | 97,456 | ||||||
Notes payable – Galenica,
Ltd.
|
- | 1,000,000 | ||||||
Interest payable – Galenica,
Ltd.
|
- | 54,000 | ||||||
Total current
liabilities
|
937,930 | 16,934,551 | ||||||
Deferred
rent
|
18,101 | - | ||||||
TOTAL
LIABILITIES
|
956,031 | 16,934,551 | ||||||
COMMITMENTS
|
||||||||
STOCKHOLDERS’ EQUITY (DEFICIENCY)
|
||||||||
Common stock - $0.001 par
value: 40,000,000 shares authorized, 11,408,288 shares issued
and outstanding at September 30, 2010; 33,000,000 shares authorized,
787,010 shares issued and outstanding at December 31,
2009
|
11,408 | 787 | ||||||
Common stock – Non-Voting
Subordinated Class A, $0.001 par value: none authorized, issued or
outstanding at September 30, 2010; 5,000,000 shares authorized, 193,936
shares issued and outstanding at December 31, 2009
|
- | 194 | ||||||
Deferred stock
issuances
|
(27 | ) | (27 | ) | ||||
Additional paid-in
capital
|
43,498,877 | 10,621,190 | ||||||
Deficit accumulated during the
development stage
|
(34,733,476 | ) | (25,331,043 | ) | ||||
TOTAL STOCKHOLDERS’ EQUITY
(DEFICIENCY)
|
8,776,782 | (14,708,899 | ) | |||||
TOTAL LIABILITIES AND
STOCKHOLDERS’ EQUITY (DEFICIENCY)
|
$ | 9,732,813 | $ | 2,225,652 |
See Notes
to Unaudited Condensed Financial Statements
1
CORMEDIX
INC.
(A
Development Stage Company)
CONDENSED
STATEMENTS OF OPERATIONS
(Unaudited)
For
the Three Months Ended September 30, 2010
|
For
the Three Months Ended September 30, 2009
|
For
the Nine Months Ended September 30, 2010
|
For
the Nine Months Ended September 30, 2009
|
Cumulative
Period from July 28, 2006 (inception) Through September 30,
2010
|
||||||||||||||||
OPERATING
EXPENSES
|
||||||||||||||||||||
Research
and development
|
$ | 760,533 | $ | 470,162 | $ | 4,417,884 | $ | 994,195 | $ | 16,962,333 | ||||||||||
General
and administrative
|
642,254 | 343,619 | 1,906,872 | 1,090,386 | 6,683,064 | |||||||||||||||
Total
Operating Expenses
|
1,402,787 | 813,781 | 6,324,756 | 2,084,581 | 23,645,397 | |||||||||||||||
LOSS
FROM OPERATIONS
|
(1,402,787 | ) | (813,781 | ) | (6,324,756 | ) | (2,084,581 | ) | (23,645,397 | ) | ||||||||||
OTHER
INCOME (EXPENSE)
|
||||||||||||||||||||
Interest
income
|
10,375 | 21 | 16,086 | 2,104 | 104,949 | |||||||||||||||
Interest
expense, including amortization and write-off of deferred financing costs
and debt discounts
|
- | (422,499 | ) | (3,093,763 | ) | (1,498,510 | ) | (11,193,028 | ) | |||||||||||
NET
LOSS
|
$ | (1,392,412 | ) | $ | (1,236,259 | ) | $ | (9,402,433 | ) | $ | (3,580,987 | ) | $ | (34,733,476 | ) | |||||
NET
LOSS PER SHARE – BASIC AND DILUTED
|
$ | (0.12 | ) | $ | (1.47 | ) | $ | (1.10 | ) | $ | (4.25 | ) | ||||||||
WEIGHTED
AVERAGE SHARES OUTSTANDING – BASIC AND DILUTED
|
11,408,288 | 842,788 | 8,546,248 | 842,364 |
See Notes
to Unaudited Condensed Financial Statements
2
CORMEDIX
INC.
(A
Development Stage Company)
CONDENSED
STATEMENT OF CHANGES IN
STOCKHOLDERS’
EQUITY (DEFICIENCY)
(Unaudited)
For
the Nine Months Ended September 30, 2010
Common
Stock
|
Non-Voting
Common
Stock –
Class
A
|
Deferred
Stock
Issuances
|
Additional
Paid-in
Capital
|
Deficit
Accumulated
During
the
Development
Stage
|
Total
Stockholders’ Equity (Deficiency)
|
|||||||||||||||||||||||||||
Shares
|
Amount
|
Shares
|
Amount
|
|||||||||||||||||||||||||||||
Balance
at January 1, 2010
|
787,010 | $ | 787 | 193,936 | $ | 194 | $ | (27 | ) | $ | 10,621,190 | $ | (25,331,043 | ) | $ | (14,708,899 | ) | |||||||||||||||
Common
stock issued to consultant at $32.05 per share in February
2010
|
4,059 | 4 | 130,087 | 130,091 | ||||||||||||||||||||||||||||
Common
stock issued upon conversion of Class A Non- Voting Common Stock at a 1
for 7.836 conversion rate in February 2010
|
24,750 | 25 | (193,936 | ) | (194 | ) | 169 | - | ||||||||||||||||||||||||
Common
stock issued from debt conversion to noteholders in March
2010
|
5,914,445 | 5,914 | 18,891,253 | 18,897,167 | ||||||||||||||||||||||||||||
Common
stock issued to licensors at $3.125 per share in March
2010
|
828,024 | 828 | 2,586,748 | 2,587,576 | ||||||||||||||||||||||||||||
Common
stock issued in initial public offering at $3.125 per share in March 2010,
net of issuance costs
|
3,850,000 | 3,850 | 10,453,420 | 10,457,270 | ||||||||||||||||||||||||||||
Stock-based
compensation
|
816,010 | 816,010 | ||||||||||||||||||||||||||||||
Net
loss
|
(9,402,433 | ) | (9,402,433 | ) | ||||||||||||||||||||||||||||
Balance
at September 30, 2010
|
11,408,288 | $ | 11,408 | - | $ | - | $ | (27 | ) | $ | 43,498,877 | $ | (34,733,476 | ) | $ | 8,776,782 |
See Notes
to Unaudited Condensed Financial Statements
3
CORMEDIX
INC.
(A
Development Stage Company)
CONDENSED
STATEMENTS OF CASH FLOWS
(Unaudited)
For
the Nine Months Ended September 30, 2010
|
For
the Nine Months Ended September 30, 2009
|
Period
from July 28, 2006 (Inception) To September 30,
2010
|
||||||||||
CASH
FLOWS FROM OPERATING ACTIVITIES:
|
||||||||||||
Net
loss
|
$ | (9,402,433 | ) | $ | (3,580,987 | ) | $ | (34,733,476 | ) | |||
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
||||||||||||
Stock-based
compensation
|
816,010 | 88,329 | 1,281,406 | |||||||||
Stock
issued in connection with license agreements
|
2,587,576 | - | 6,983,370 | |||||||||
Stock
issued in connection with consulting agreement
|
130,091 | - | 158,262 | |||||||||
Amortization
of deferred financing costs
|
358,495 | 123,532 | 2,047,881 | |||||||||
Amortization
of debt discount
|
1,135,076 | 435,875 | 4,979,461 | |||||||||
Non-cash
charge for beneficial conversion feature
|
1,137,762 | - | 1,137,762 | |||||||||
Non-cash
interest expense
|
462,430 | 939,852 | 3,007,017 | |||||||||
Expenses
paid on behalf of the Company satisfied through the issuance of
notes
|
- | - | 51,253 | |||||||||
Depreciation
|
8,770 | 7,458 | 34,377 | |||||||||
Changes
in operating assets and liabilities:
|
||||||||||||
Prepaid
expenses and other current assets
|
6,592 | 69,102 | (171,522 | ) | ||||||||
Security
deposits
|
(1,609 | ) | - | (13,342 | ) | |||||||
Accounts
payable
|
(32,516 | ) | 96,796 | 517,122 | ||||||||
Accrued
expenses
|
345,808 | 358,759 | 420,808 | |||||||||
Deferred
rent
|
18,101 | - | 18,101 | |||||||||
Net
cash used in operating activities
|
(2,429,847 | ) | (1,461,284 | ) | (14,281,520 | ) | ||||||
CASH
FLOWS FROM INVESTING ACTIVITIES:
|
||||||||||||
Purchase
of equipment
|
(10,361 | ) | - | (60,084 | ) | |||||||
Net
cash used in investing activities
|
(10,361 | ) | - | (60,084 | ) | |||||||
CASH
FLOWS FROM FINANCING ACTIVITIES:
|
||||||||||||
Proceeds
from notes payable to related parties
|
- | 165,000 | 2,465,749 | |||||||||
Proceeds
from senior convertible notes
|
- | - | 13,364,973 | |||||||||
Proceeds
from Galenica, Ltd. promissory note
|
- | - | 1,000,000 | |||||||||
Deferred
financing costs
|
- | (59,635 | ) | (1,447,400 | ) | |||||||
Repayment
of amounts loaned under related party notes
|
- | - | (1,981,574 | ) | ||||||||
Proceeds
from sale of equity securities, net of issuance costs
|
10,457,270 | - | 10,457,270 | |||||||||
Proceeds
from receipt of stock subscriptions and issuances of common
stock
|
- | - | 4,827 | |||||||||
Net
cash provided by financing activities
|
10,457,270 | 105,365 | 23,863,845 | |||||||||
NET
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS
|
8,017,062 | (1,355,919 | ) | 9,522,241 | ||||||||
CASH
AND CASH EQUIVALENTS – BEGINNING OF PERIOD
|
1,505,179 | 1,380,012 | - | |||||||||
CASH
AND CASH EQUIVALENTS – END OF PERIOD
|
$ | 9,522,241 | $ | 24,093 | $ | 9,522,241 | ||||||
Cash
paid for interest
|
$ | - | $ | - | $ | 18,425 | ||||||
Supplemental
Disclosure of Non-Cash Financing Activities:
|
||||||||||||
Conversion
of notes payable and accrued interest to common
stock
|
$ | 18,897,167 | $ | - | $ | 18,897,167 | ||||||
Reclassification
of deferred financing fees to additional paid-in capital
|
$ | 148,014 | $ | - | $ | 148,014 | ||||||
Stock
issued to technology finders and licensors
|
$ | - | $ | - | $ | 155 | ||||||
Warrants
issued to placement agent
|
$ | - | $ | - | $ | 748,495 | ||||||
Debt
discount on senior convertible notes
|
$ | - | $ | - | $ | 4,979,461 |
See Notes
to Unaudited Condensed Financial Statements
4
CORMEDIX
INC.
(A
Development Stage Company)
NOTES
TO UNAUDITED CONDENSED FINANCIAL STATEMENTS
Note
1 — Organization, Business and Basis of Presentation:
Organization
and Business:
Basis
of Presentation:
The
accompanying unaudited condensed financial statements have been prepared in
accordance with accounting principles generally accepted in the United States of
America and the rules of the Securities and Exchange Commission for interim
financial information. Accordingly, the unaudited condensed financial
statements do not include all information and footnotes required by accounting
principles generally accepted in the United States of America for complete
annual financial statements. In the opinion of management, the
accompanying unaudited condensed financial statements reflect all adjustments,
consisting of normal recurring adjustments, considered necessary for a fair
presentation of such interim results. Interim operating results are
not necessarily indicative of results that may be expected for the full year
ending December 31, 2010 or for any subsequent period. These
unaudited condensed financial statements should be read in conjunction with the
audited financial statements and notes thereto of the Company which are included
in the Company’s registration statement on Form S-1, which was declared
effective by the Securities and Exchange Commission on March 24,
2010. The accompanying condensed balance sheet as of December 31,
2009 has been derived from the audited financial statements included in such
Form S-1.
The
Company’s primary activities since incorporation have been organizational
activities, including recruiting personnel, establishing office facilities,
acquiring licenses for its pharmaceutical compound pipeline, performing business
and financial planning, performing research and development and raising funds
through the issuance of debt and common stock. The Company has not
generated any revenues and, accordingly, the Company is considered to be in the
development stage.
On
February 24, 2010, the Company effected a 1 for 7.836 reverse stock split of its
common stock. All share and per-share information in these unaudited
condensed financial statements has been adjusted to give effect to the reverse
stock split.
The
Company’s financial statements have been prepared on a going concern basis,
which contemplates the realization of assets and the settlement of liabilities
and commitments through the normal course of business. The condensed
financial statements do not include any adjustments to reflect the possible
future effects on the recoverability and classification of assets or the amounts
and classification of liabilities. The Company has sustained
operating losses since its inception and expects that such losses will continue
over the next several years. Management believes that the currently
available capital resources will be sufficient to meet the Company’s operating
needs through the end of the first quarter of 2012. For the nine
months ended September 30, 2010 and the period from July 28, 2006 (inception) to
September 30, 2010, the Company incurred net losses of $9,402,433 and
$34,733,476, respectively.
5
CORMEDIX
INC.
(A
Development Stage Company)
NOTES
TO UNAUDITED CONDENSED FINANCIAL STATEMENTS
Note
2 — Summary of Significant Accounting Policies:
Use
of Estimates:
The
preparation of financial statements in conformity with accounting principles
generally accepted in the United States of America requires management to make
estimates and assumptions that affect the reported amounts of assets and
liabilities and disclosure of contingent assets and liabilities at the date of
the financial statements and reported amounts of revenue and expenses during the
reporting period. Actual results could differ from those
estimates.
Loss
per common share:
Basic
earnings (loss) per common share excludes dilution and is computed by dividing
net income (loss) by the weighted average number of common shares outstanding
during the period. Diluted earnings per common share reflect the
potential dilution that could occur if securities or other contracts to issue
common stock were exercised or converted into common stock or resulted in the
issuance of common stock that then shared in the earnings of the
entity. Since the Company has only incurred losses, basic and diluted
loss per share are the same. The amount of potentially dilutive
securities excluded from the calculation was 6,472,767 and 2,663,607 shares of
common stock being held in escrow, convertible notes, warrants and options at
September 30, 2010 and 2009, respectively.
Stock
Based Compensation:
The
Company accounts for stock options granted to employees according to the
Financial Accounting Standards Board Accounting Standards Codification No. 718
(“ASC 718”), “Compensation — Stock Compensation”. Under ASC
718, share-based compensation cost is measured at grant date, based on the
estimated fair value of the award, and is recognized as expense over the
employee’s requisite service period on a straight-line basis.
The
Company accounts for stock options granted to non-employees on a fair value
basis using the Black-Scholes option pricing method in accordance with ASC
718. The non-cash charge to operations for non-employee options with
vesting are revalued at the end of each reporting period based upon the change
in the fair value of the options and amortized to consulting expense over the
related vesting period.
During
the nine months ended September 30, 2010 options to purchase 1,639,215 shares of
common stock were issued to employees and directors. There were no
options granted during the nine months ended September 30, 2009.
Note
3 — Related Party Transactions:
Consulting
Services:
Effective
August 1, 2006, the Company began accruing monthly fees for consulting services
at a rate of $25,000 per month payable to Paramount Corporate Development, LLC
(“Paramount”), an affiliate of a significant stockholder of the Company,
pursuant to a services agreement with Paramount. This agreement was
terminated as of August 31, 2008 and, accordingly, there was no consulting
services expense under this agreement for the nine months ended September 30,
2010 and 2009. For the period from July 28, 2006 (inception) to
September 30, 2010, consulting services expense under this agreement was
$625,000. As of September 30, 2010 and December 31, 2009, the Company
had $75,000 payable to Paramount pursuant to this agreement, which amount is
included in accrued expenses.
6
CORMEDIX
INC.
(A
Development Stage Company)
NOTES
TO UNAUDITED CONDENSED FINANCIAL STATEMENTS
Notes
Payable:
On July
28, 2006, CorMedix issued a 5% promissory note payable to Paramount BioSciences,
LLC (“PBS”), an affiliate of a significant stockholder of the
Company. This note and all accrued interest was scheduled to mature
on June 15, 2009, or earlier if certain events occurred. The maturity
date of this note was extended until July 31, 2010. The note was
issued to PBS for expenses that PBS has paid on behalf of the Company. On March 30, 2010, in conjunction with the closing
of the Company’s initial public offering (the “IPO”) of units, each consisting
of two shares of the Company’s common stock and a warrant to purchase one share
of the Company’s common stock at an exercise price of $3.4375 (“Units”), the
principal and accrued interest amount outstanding under this note, which was
$198,264 on such date, converted into 30,499 Units, which consist of 60,998
shares of common stock and 30,499 warrants with an exercise price of
$3.4375. See Note 8.
On August
11, 2006, CorMedix issued a 5% promissory note payable to an entity related to
the sole member of PBS. This note and all accrued interest was to
mature on August 11, 2009, or earlier if certain events occur. The
maturity date of this note was extended until July 31, 2010. On March
30, 2010, the principal and accrued interest amount under this note was
$452,007, which converted into 69,539 Units, which consist of 139,078 shares of
common stock and warrants to purchase 69,539 shares of common stock at an
exercise price of $3.4375, in conjunction with the IPO. See Note
8.
Note
4 — Stockholders’ Equity (Deficiency):
Common
Stock:
During
the nine months ended September 30, 2010 the Company recorded compensation
expense in connection with common stock issued to employees of $1,296 and
consultants of $130,091, each with a three-year vesting period. The
Company recorded compensation expense, in connection with common stock issued to
consultants of $158,262 for the period from July 28, 2006 (inception) to
September 30, 2010. There were no such common stock issuances for the
nine months ended September 30, 2009.
Common
Stock Options and Warrants:
During
the nine months ended September 30, 2010, the Company granted options to
purchase 1,639,215 shares of common stock under the Amended and Restated 2006
Stock Incentive Plan (“Plan”) to various employees, officers and directors,
including options to purchase 1,589,215 shares at an exercise price of $3.125
per share and options to purchase 50,000 shares at an exercise price of $1.57
per share. Each option granted to employees during the nine months
ended September 30, 2010 has a ten-year term and vests equally over a three-year
period. The options granted to directors during the nine months ended
September 30, 2010 have ten-year terms and vested one-third on March 30, 2010,
the date of grant, and the remaining two-thirds will vest equally over a
two-year period. The Company recorded $814,714, $88,329 and
$1,281,406 of compensation expense during the nine months ended September 30,
2010 and 2009 and the period from July 28, 2006 (inception) to September 30,
2010, respectively, in accordance with ASC 718.
There
were no options or warrants issued during the nine months ended September 30,
2009.
7
CORMEDIX
INC.
(A
Development Stage Company)
NOTES
TO UNAUDITED CONDENSED FINANCIAL STATEMENTS
The
Company records compensation expense associated with stock options and other
forms of equity compensation using the Black-Scholes option-pricing model and
the following assumptions:
Nine
Months Ended
September
30, 2010
|
|
Expected
Term
|
5
years
|
Volatility
|
112%
- 114%
|
Dividend
yield
|
0.0%
|
Risk-free
interest rate
|
1.5%
- 2.6%
|
The
Company estimated the expected term of the stock options granted based on
anticipated exercises in future periods assuming the success of our business
model as currently forecasted. Given the Company’s short period of
publicly-traded stock history, management’s estimate of expected volatility is
based on the average expected volatilities of a sampling of five companies with
similar attributes to the Company, including: industry, stage of life cycle,
size and financial leverage. The Company will continue to analyze the
expected stock price volatility and expected term assumptions as more historical
data for the Company’s common stock becomes available. The expected
dividend yield reflects the Company’s current and expected future policy for
dividends on the Company’s common stock. To determine the risk-free
interest rate, the Company utilized the U.S. Treasury yield curve in effect at
the time of grant with a term consistent with the expected term of the Company’s
awards. Given that the stock options currently outstanding are
primarily held by senior management and directors of the Company, management
does not currently expect to experience any forfeitures with respect to such
options and, as such, compensation expense for stock-based awards does not
include an estimate for forfeitures.
A summary
of the Company’s option and warrant activity under the Plan and related
information is as follows:
Nine
Months Ended
September
30, 2010
|
Nine
Months Ended
September
30, 2009
|
|||||||||||||||
Shares
|
Weighted
Average
Exercise
Price
|
Shares
|
Weighted
Average
Exercise
Price
|
|||||||||||||
Outstanding
at beginning of period
|
23,612 | $ | 8.23 | 23,612 | $ | 8.23 | ||||||||||
Granted
|
1,639,215 | $ | 3.08 | - | $ | - | ||||||||||
Outstanding
at end of period and expected to vest
|
1,662,827 | $ | 3.15 | 23,612 | $ | 8.23 | ||||||||||
Options
exercisable
|
57,231 | $ | 4.66 | 16,380 | $ | 8.23 | ||||||||||
Weighted-average
fair value of options granted during the period
|
$ | 2.47 | $ | 6.82 |
The
weighted average remaining contractual life of stock options outstanding at
September 30, 2010 is 9.4 years. The aggregate intrinsic value is
calculated as the difference between the exercise prices of the underlying
options and the quoted closing price of the common stock of the Company as of
September 30, 2010 for those options that have an exercise price below the
quoted closing price. As of September 30, 2010, there were options to
purchase an aggregate of 1,662,827 shares with an exercise price above the
quoted closing price of the common stock of the Company, resulting in $0
intrinsic value.
8
CORMEDIX
INC.
(A
Development Stage Company)
NOTES
TO UNAUDITED CONDENSED FINANCIAL STATEMENTS
As of
September 30, 2010, the total compensation expense related to non-vested options
not yet recognized totaled $3,298,005. The weighted-average vesting
period over which the total compensation expense related to non-vested options
not yet recognized at September 30, 2010 was approximately 2.5 years.
Note
5 — Convertible Notes:
In
connection with the closing of the IPO, which occurred on March 30, 2010, all of
the Company’s outstanding convertible notes converted into Units or shares of
common stock, as described below, in accordance with the terms of such
notes. See Note 8.
In July
and September 2007, the Company issued 8% senior convertible notes in connection
with a private placement in the aggregate principal amount of $8,645,000 (the
“First Bridge Notes”) with an original maturity date of July 31, 2008, which was
subsequently extended to July 31, 2009. The First Bridge Notes were amended on
June 5, 2009 to extend the maturity date to July 31, 2010 and to provide for an
interest rate per annum of 10% per annum from June 5, 2009 until July 31, 2009,
and 12% per annum from and after August 1, 2009. On March 30, 2010,
the aggregate amount of principal and accrued interest outstanding under the
First Bridge Notes was $11,036,837 and the First Bridge Notes converted into an
aggregate of 1,697,971 Units, which consist of 3,395,942 shares of common stock
and warrants to purchase 1,697,971 shares of common stock at an exercise price
of $3.4375, in conjunction with the IPO.
In August
2008, the Company issued 8% senior convertible notes in connection with a
private placement in the aggregate principal amount of $2,100,000 (the “Second
Bridge Notes”) with an original maturity date of July 31, 2009. The Second
Bridge Notes were amended on June 5, 2009 to extend the maturity date to July
31, 2010 and to provide for an interest rate of 10% per annum from June 5, 2009
until July 31, 2009, and 12% per annum from and after August 1, 2009. On March
30, 2010, the aggregate amount of principal and accrued interest outstanding
under the Second Bridge Notes was $2,440,368 and the Second Bridge Notes
converted into an aggregate of 375,437 Units, which consist of 750,874 shares of
common stock and warrants to purchase 375,437 shares of common stock at an
exercise price of $3.4375, in conjunction with the IPO.
On
December 10, 2008, the Company issued a promissory note with no stated interest
rate to Galenica, Ltd., a pharmaceutical company (“Galenica”), in the principal
amount of $1,000,000, in connection with a proposed purchase agreement between
the Company and Galenica. As a result of the termination of the proposed
purchase agreement, on April 30, 2009, this promissory note was cancelled and
the Company issued to Galenica a new promissory note in the principal amount of
$1,000,000, with an interest rate of 8% and a maturity date of July 31, 2010
(the “Galenica Note”). Except for the interest rate, the terms of the Galenica
Note were consistent with the terms of the Second Bridge Notes. On
March 30, 2010, the amount of principal and accrued interest outstanding under
the Galenica Note was $1,073,333 and the Galenica Note converted into 165,128
Units, which consist of 330,256 shares of common stock and warrants to purchase
165,128 shares of common stock at an exercise price of $3.4375, in conjunction
with the IPO.
In
October and November 2009, the Company issued 8% senior convertible notes in
connection with a private placement in the aggregate principal amount of
$2,619,973 (the “Third Bridge Notes”) with a maturity date of October 29,
2011. Under the terms of the Third Bridge Notes, the aggregate amount
of principal and accrued interest automatically converted into shares of the
Company’s common stock upon completion of the IPO at a price equal to 70% of the
portion of the offering price of the Units sold in the IPO that was allocated to
the common stock, which was $3.125. Accordingly, on March 30, 2010,
the aggregate amount of principal and accrued interest outstanding under the
Third Bridge Notes, which was $2,706,594, converted into 1,237,293 shares of
common stock in conjunction with the IPO. The beneficial conversion
feature of the Third Bridge Notes as a result of the 30% discount at which the
Third Bridge Notes converted into shares of common stock upon the IPO was valued
at $1,137,762, which was recorded to interest expense on March 30,
2010.
9
CORMEDIX
INC.
(A
Development Stage Company)
NOTES
TO UNAUDITED CONDENSED FINANCIAL STATEMENTS
In
addition, in connection with the private placement of the Third Bridge Notes,
each noteholder received warrants to purchase a number of shares of the
Company’s common stock equal to 60% of the principal amount of the Third Bridge
Notes purchased divided by $3.125, the portion of the offering price of the
Units sold in the IPO that was allocated to the common stock. These
warrants have an exercise price of $3.4375, the same exercise price as the
warrants underlying the Units sold in the IPO, and are exercisable for a period
of five years.
Note
6 — Shares Issued to Licensors:
In
accordance with the terms of agreements with the Company’s licensors, Shiva
Biomedical, LLC (“Shiva”) and ND Partners, LLC (“ND Partners”), the Company was
obligated to issue additional shares of common stock to each licensor sufficient
to maintain an ownership percentage of 7% of the outstanding common stock of the
Company on a fully diluted basis. As a result of the automatic
conversion of all of the Company’s outstanding convertible notes into Units and
shares common stock in connection with the closing of the IPO, on March 30,
2010, the Company issued in the aggregate 828,024 shares of common stock to
Shiva and ND Partners at a price of $3.125 per share resulting in a charge of
$2,587,576, in accordance with this obligation. This obligation terminated upon
the closing of the IPO.
Note
7 — Commitments:
On
February 16, 2010, the Company entered into an employment agreement with Brian
Lenz, effective February 16, 2010, to act as the Company’s Chief Financial
Officer (the “Lenz Employment Agreement”). The Lenz Employment
Agreement has an initial term of two years, and thereafter is automatically
extended for additional one-year periods unless either party provides the other
with appropriate notice of its decision not to extend the
term. Pursuant to the Lenz Employment Agreement, Mr. Lenz receives an
annual base salary of $175,000, and guaranteed bonuses of $15,000 upon the last
business day of the first calendar year during the term and $25,000 upon the
last business day of the second and each following calendar year during the
term, provided that Mr. Lenz remains the Company’s
employee. Additionally, Mr. Lenz is eligible for annual milestone
bonus payments of up to 30% of the aggregate of his base salary and guaranteed
bonus, as established annually by the Company’s Chief Executive Officer, in
conjunction with the Company’s Board of Directors or a committee
thereof. The Lenz Employment Agreement also provided for a $10,000
bonus, which was paid in May 2010, and the issuance of an option to purchase
326,492 shares of common stock representing 2.0% of the common stock outstanding
upon the consummation of the IPO on a fully diluted basis. Such
option has an exercise price equal to $3.125, the price of the Units sold in
this offering that is allocated to the common stock and will vest in equal
installments on each of the first three anniversaries of the grant
date. The stock option grant had an approximate fair value of
$818,800 at the date of grant based on the Black-Scholes option-pricing
model. The Lenz Employment Agreement also entitles Mr. Lenz to
certain severance benefits.
On March
18, 2010, the Company entered into a lease agreement with UA Bridgewater
Holdings, LLC for office space located in Bridgewater, New Jersey, for an
initial term of 60 months, with a commencement date of April 1, 2010, an
expiration date of March 31, 2015, and lease payments beginning on July 1,
2010. In accordance with the lease agreement, the Company has
deposited $13,342 with the landlord, the equivalent of two months’
rent. The Company has a one-time right to terminate the lease after
two years from the commencement date, provided the Company gives the landlord
notice of its election to exercise this option on or before 18 months after
April 1, 2010. If the Company elects to exercise the early
termination option, the Company will pay an early cancellation fee to the
landlord in an amount equal to the sum of the following: the
remaining balance of the unamortized leasing costs incurred by the landlord; the
brokerage commissions; the landlord’s legal fees associated with this lease; and
$18,474, representing three months base rent. The Company also has
been granted the option to extend the lease term for one additional period of
three years, commencing the day following the then-current expiration date of
the term, March 31, 2015, provided the Company delivers notice to the landlord
no later than nine months prior to March 31, 2015. The total 60 month
lease obligation is approximately $389,000.
10
CORMEDIX
INC.
(A
Development Stage Company)
NOTES
TO UNAUDITED CONDENSED FINANCIAL STATEMENTS
Note
8 — Initial Public Offering:
In March
2010, the Company completed its IPO, whereby the Company sold 1,925,000 Units,
each Unit consisting of two shares of its common stock and a warrant to purchase
one share of common stock, at $6.50 per Unit resulting in gross proceeds of
$12,512,500. In connection with the IPO, the Company paid
underwriting discounts and commissions of $1,063,563, corporate finance fees of
$225,250 and reimbursable legal expenses of counsel for the underwriters of
$90,000, and the Company incurred other offering costs and expenses, including
legal, accounting, printing and filing fees totaling $678,284.
All of
the Company’s convertible notes and all of the Company’s outstanding shares of
Non-Voting Subordinated Class A Common Stock automatically converted into Units
or common stock upon the completion of the IPO. Management believes
that the net proceeds from the IPO and existing cash will be sufficient to fund
the Company’s projected operating requirements through the end of the first
quarter of 2012.
Note
9 — Fair Value Measurements:
The fair
value of the Company’s cash and cash equivalents, accounts payable and other
accrued liabilities at September 30, 2010 are estimated to approximate their
carrying values due to the relative liquidity and short term nature of these
instruments.
Note
10 – Subsequent Event:
On
October 29, 2010, the Company was issued a letter from the Department of the
Treasury indicating it has been awarded two federally funded grants totaling
$488,959 under the qualifying
therapeutic discovery project ("QTDP") program established under Section 48D of
the Internal Revenue Code. These grants were awarded based on applications
CorMedix submitted for both its Neutrolin® and Deferiprone programs.
11
Item
2.
|
Management’s
Discussion and Analysis of Financial Condition and Results of
Operations.
|
The following discussion and analysis of our
financial condition and results of operations should be read in conjunction with
our condensed consolidated financial statements and related notes appearing
elsewhere in this Quarterly Report on Form 10-Q and our Prospectus filed
pursuant to Rule 424(b) under the Securities Act of 1933, as amended
(the “Securities Act”), with the Securities and Exchange Commission (the “SEC”)
on March 26,
2010.
Forward
Looking Statements
This
quarterly report on Form 10-Q contains “forward-looking statements” that
involve risks and uncertainties, as well as assumptions that, if they never
materialize or prove incorrect, could cause our results to differ materially
from those expressed or implied by such forward-looking
statements. The statements contained in this Quarterly Report on
Form 10-Q that are not purely historical are forward-looking statements
within the meaning of Section 27A of the Securities Act and
Section 21E of the Securities Exchange Act of 1934, as amended (the
“Exchange Act”). Forward-looking statements are often identified by
the use of words such as, but not limited to, “anticipate,” “believe,” “can,”
“continue,” “could,” “estimate,” “expect,” “intend,” “may,” “will,” “plan,”
“project,” “seek,” “should,” “target,” “will,” “would,” and similar expressions
or variations intended to identify forward-looking statements. These
statements are based on the beliefs and assumptions of our management based on
information currently available to management. Such forward-looking
statements are subject to risks, uncertainties and other important factors that
could cause actual results and the timing of certain events to differ materially
from future results expressed or implied by such forward-looking
statements. Factors that could cause or contribute to such
differences include, but are not limited to, those identified below, and those
discussed in the section titled “Risk Factors” included in our Prospectus filed
pursuant to Rule 424(b) under the Securities Act with the SEC on March
26, 2010. Furthermore, such forward-looking statements speak only as
of the date of this report. Except as required by law, we undertake
no obligation to update any forward-looking statements to reflect events or
circumstances after the date of such statements.
Overview
We are a
pharmaceutical company that seeks to in-license, develop and commercialize
therapeutic products for the treatment of cardiac and renal dysfunction, also
known as Cardiorenal disease. Specifically, our goal is to treat
kidney disease by reducing the commonly associated cardiovascular and metabolic
complications — in effect, “Treating the kidney to treat the
heart.” To date, we have licensed all of the products in our
Cardiorenal pipeline.
We have
the worldwide rights to develop and commercialize several proprietary product
candidates in clinical development that address large market opportunities,
including our most advanced product candidates, CRMD003 (Neutrolin®) and
CRMD001.
CRMD003
is a liquid designed to prevent central venous catheter related bloodstream
infections (“CRBI”) and clotting in central venous catheters (initially in
hemodialysis catheters). We intend to submit an Investigational
Device Exemption for CRMD003 by the end of 2010, which if approved will enable
us to start a pivotal clinical trial in 2011.
CRMD001
is our oral formulation of the drug deferiprone, which we intend to develop for
use in the prevention of contrast-induced nephropathy, or CIN, which is a common
and potentially serious complication arising from the use of iodinated contrast
media used in X-ray procedures to identify the status of blood vessels in the
heart. Following our assessment of the data generated in connection
with our development of CRMD001 for the CIN indication, we will consider whether
or not to also develop CRMD001 for use in the treatment of chronic kidney
disease, or CKD, based on the support such data provides for this additional
indication as well as other factors, including our access to capital, clinical
and regulatory considerations regarding development of CRMD001 for the CKD
indication, and our assessment of the then-current state of our intellectual
property estate in CRMD001 with respect to both the CIN and the CKD
indications. In June 2010, we initiated patient dosing in a phase II
biomarker “proof of concept” study for the CIN indication. We believe
this study will generate supportive data on the ability of CRMD001 to reduce
biomarker evidence of acute kidney injury and provide other information that
will increase the likelihood of success of a later phase III trial for the CIN
indication.
12
We are a
development stage company. We were organized as a Delaware
corporation on July 28, 2006 under the name “Picton Holding Company, Inc.” and
we changed our corporate name to “CorMedix Inc.” on January 18,
2007. Since our inception, we have had no revenue from product
sales. Our operations to date have been primarily limited to
organizing and staffing, licensing product candidates, developing clinical
trials for our product candidates, establishing manufacturing for our product
candidates and maintaining and improving our patent portfolio. We
have generated significant losses to date, and we expect to continue to generate
losses as we progress towards the commercialization of our product candidates,
including CRMD003 and CRMD001. As of September 30, 2010, we had an
accumulated deficit of $34,733,476. Because we do not generate
revenue from any of our product candidates, our losses will continue as we
advance our product candidates towards regulatory approval and eventual
commercialization. As a result, our operating losses are likely to be
substantial over the next several years. We are unable to predict the
extent of any future losses or when we will become profitable, if at
all.
In March
2010, we completed our initial public offering (the “IPO”), whereby we sold
1,925,000 units, each unit consisting of two shares of our common stock and a
warrant to purchase one share of common stock, at $6.50 per unit resulting in
gross proceeds of $12,512,500 and net proceeds to us of $10,457,270 after
deducting underwriting discounts and commissions and offering expenses payable
by us. All of our convertible notes and accrued interest thereon and
all of our outstanding shares of Non-Voting Subordinated Class A Common Stock
automatically converted into units or common stock upon the completion of the
IPO. We believe that the net proceeds from the IPO and existing cash
will be sufficient to fund our projected operating requirements through the end
of the first quarter of 2012.
We also
effected a 1 for 7.836 reverse stock split of our common stock on February 24,
2010 in connection with the IPO. All shares and per share amounts,
except as noted, have been retroactively adjusted to give effect to the reverse
stock split.
Financial
Operations Overview
Revenue
We have
not generated any revenue since our inception. As of September 30,
2010, we have funded our operations primarily through debt financings and the
IPO.
If our
product development efforts result in clinical success, regulatory approval and
successful commercialization of any of our products, we could generate revenue
from sales or licenses of any such products.
13
Research
and Development Expense
Research
and development expense consists of: (i) internal costs associated with our
development activities; (ii) payments we make to third party contract research
organizations, contract manufacturers, investigative sites, and consultants;
(iii) technology and intellectual property license costs; (iv) manufacturing
development costs; (v) personnel related expenses, including salaries, benefits,
travel and related costs for the personnel involved in drug development; (vi)
activities relating to regulatory filings and the advancement of our product
candidates through preclinical studies and clinical trials; and (vii) facilities
and other allocated expenses, which include direct and allocated expenses for
rent, facility maintenance, as well as laboratory and other supplies. All
research and development is expensed as incurred.
Conducting
a significant amount of development is central to our business
model. Through September 30, 2010, we incurred $16,962,333 in
research and development expenses since our inception in July
2006. Product candidates in later-stage clinical development
generally have higher development costs than those in earlier stages of
development, primarily due to the significantly increased size and duration of
the clinical trials. We plan to increase our research and development
expenses for the foreseeable future in order to complete development of our two
most advanced product candidates, CRMD003 and CRMD001, and our earlier-stage
research and development projects.
The
following table summarizes the percentages of our research and development
payments related to our two most advanced product candidates and other
projects. The percentages summarized in the following table reflect
payments directly attributable to each development candidate, which are tracked
on a project basis. A portion of our internal costs, including
indirect costs relating to our product candidates, are not tracked on a project
basis and are allocated based on management’s estimate.
Nine
Months Ended
September 30,
|
Period
from July 28,
2006
(Inception)
through
September 30, 2010
|
|||||||||||
2010
|
2009
|
|||||||||||
CRMD003
|
53 | % | 72 | % | 32 | % | ||||||
CRMD001
|
45 | % | 24 | % | 65 | % | ||||||
CRMD002
|
1 | % | 0 | % | 1 | % | ||||||
CRMD004
|
1 | % | 4 | % | 2 | % |
The
process of conducting pre-clinical studies and clinical trials necessary to
obtain U.S. Food and Drug Administration approval is costly and time
consuming. The probability of success for each product candidate and
clinical trial may be affected by a variety of factors, including, among others,
the quality of the product candidate’s early clinical data, investment in the
program, competition, manufacturing capabilities and commercial
viability. As a result of the uncertainties discussed above, the
uncertainty associated with clinical trial enrollments and the risks inherent in
the development process, we are unable to determine the duration and completion
costs of current or future clinical stages of our product candidates or when, or
to what extent, we will generate revenues from the commercialization and sale of
any of our product candidates.
Development
timelines, probability of success and development costs vary
widely. We are currently focused on developing our two most advanced
product candidates, CRMD003 for the prevention of CRBI and CRMD001 for the CIN
indication. We expect to raise additional funds at a later date in
order to fully complete the development of CRMD003 for CRBI and CRMD001 for the
CIN indication, to further develop CRMD002 or CRMD004 through and beyond the
pre-clinical stage, to develop CRMD001 for the CKD indication (should we decide
to pursue such development) or to develop any new product
candidates.
14
General
and Administrative Expense
General
and administrative expense consists primarily of salaries and other related
costs, including stock-based compensation expense, for persons serving in our
executive, finance and accounting functions. Other general and
administrative expense includes facility-related costs not otherwise included in
research and development expense, promotional expenses, costs associated with
industry and trade shows, and professional fees for legal services and
accounting services. We expect that our general and administrative
expenses will increase if we add personnel and as a result of the reporting
obligations applicable to public companies. From our inception on
July 28, 2006 through September 30, 2010, we spent $6,683,064 on general and
administrative expense.
Interest
Income and Interest Expense
Interest
income consists of interest earned on our cash and cash
equivalents. Interest expense consists of interest incurred on our
convertible notes up to their automatic conversion into units or common stock
upon the completion of the IPO on March 30, 2010, as well as the amortization
and write-off of deferred financing costs and debt discounts and a charge for
the beneficial conversion relating to our convertible notes.
Results
of Operations
Three
months ended September 30, 2010 compared to three months ended September 30,
2009
Research and Development
Expense. Research and development (“R&D”) expense was
$760,533 for the three months ended September 30, 2010, an increase of $290,371,
from $470,162 for the three months ended September 30, 2009. The
increase was primarily attributable to stock-based compensation expense of
$159,305 related to all stock options granted to our Chief Medical Officer
(“CMO”) and a portion of the stock options granted to our President and Chief
Executive Officer (“CEO”) in connection with our IPO in March
2010. The increase in R&D expense was also attributable to
clinical development costs related to our Phase II clinical trial of CRMD001
which began in June 2010, higher manufacturing costs related the development of
CRMD003 and costs related to the hiring of two employees in the areas
of clinical operations and product development during the third quarter of
2010.
General and Administrative
Expense. General and administrative (“G&A”) expense was
$642,254 for the three months ended September 30, 2010, an increase of $298,635
from $343,619 for the three months ended September 30, 2009. The
increase was primarily attributable to stock-based compensation expense of
$190,306 related to a portion of the stock options granted to our CEO, and all
of the stock options granted to our Chief Financial Officer and Board members in
connection with our IPO in March 2010. The increase in G&A
expense also reflects the increased costs of operating as a publicly-traded
company following our IPO in March 2010, which include filing fees related to
the listing of our common stock, as well as increased legal, accounting and
investor relations consulting fees and increased compensation expense as a
result of our hiring a Chief Financial Officer in February 2010.
Interest Income and Interest
Expense. Interest income was $10,375 for the three months
ended September 30, 2010, an increase of $10,354, from $21 for the three months
ended September 30, 2009. The increase was attributable to having
higher interest-bearing cash balances during the third quarter 2010 as a result
of the funds received from the completion of our IPO in March 2010, compared to
the third quarter of 2009.
15
Interest
expense was $0 for the three months ended September 30, 2010, compared to
$422,499 for the three months ended September 30, 2009. The decrease
was attributable to the conversion of all our convertible notes during the first
quarter of 2010 in connection with the IPO in March 2010.
Nine
months ended September 30, 2010 compared to Nine months ended September 30,
2009
Research and Development
Expense. R&D expense was $4,417,884 for the nine months
ended September 30, 2010, an increase of $3,423,689, from $994,195 for the nine
months ended September 30, 2009. The increase was primarily
attributable to our issuance of 828,024 shares of our common stock on March 30,
2010 to our licensors valued at $3.125 per share, or $2,587,576 as a result of
anti-dilution adjustments in connection with the conversion of our outstanding
convertible debt to common stock upon the closing of the IPO. The
increase was also attributable to stock-based compensation expense of $318,648
related to all stock options granted to our CMO and a portion of the stock
options granted to our CEO in connection with the IPO. Also
contributing to the higher R&D expense were the clinical development costs
related to our Phase II clinical trial of CRMD001 which began in June 2010, and
higher manufacturing costs related the development of CRMD003 and costs related
to the hiring of two employees in the areas of clinical operations and product
development during the third quarter of 2010.
General and Administrative
Expense. G&A expense was $1,906,872 for the nine months
ended September 30, 2010, an increase of $816,486 from $1,090,386 for the nine
months ended September 30, 2009. The increase was primarily
attributable to stock-based compensation expense of $497,362 related to a
portion of the stock options granted to our CEO, and all of the stock options
granted to our Chief Financial Officer and Board members in connection with the
IPO, in addition to the issuance of 4,059 shares of our common stock to a
consultant valued at $32.05 per share or $130,091. The increase in
G&A expense also reflects the increased costs of operating as a
publicly-traded company following the IPO in March 2010, which include filing
fees related to the listing of our common stock, as well as increased legal,
accounting and investor relations consulting fees and increased compensation
expense as a result of our hiring a Chief Financial Officer in February
2010.
Interest Income and Interest
Expense. Interest income was $16,086 for the nine months ended
September 30, 2010, an increase of $13,982, from $2,104 for the nine months
ended September 30, 2009. The increase was attributable to having
higher interest-bearing cash balances during the nine months ended September 30,
2010 as a result of the funds received from the completion of our IPO in March
2010, compared to the nine months ended September 30, 2009.
Interest
expense was $3,093,763 for the nine months ended September 30, 2010, an increase
of $1,595,253 from $1,498,510 for the nine months ended September 30,
2009. The increase was primarily attributable to charges related to
the conversion of all our convertible notes, of which the aggregate amount of
principal and accrued interest as of March 30, 2010 was $18,897,167, in
connection with the IPO. These charges consisted primarily of a
beneficial conversion feature charge of $1,137,762 related to the 30% discount
at which the Third Bridge Notes converted into common stock, a write-off of debt
discount of $1,135,076, and a write-off of deferred financing fees of
$358,495.
Liquidity
and Capital Resources
Sources
of Liquidity
As a
result of our significant research and development expenditures and the lack of
any approved products to generate product sales revenue, we have not been
profitable and have generated operating losses since we were incorporated in
July 2006. Prior to the IPO, we had funded our operations principally
with $14,364,973 in convertible notes sold in private placements and $625,464 in
related party notes, which were also convertible. We received net
proceeds of $10,457,270 from the IPO, after deducting underwriting discounts,
commissions and offering expenses payable by us upon the closing of the IPO on
March 30, 2010. All of our convertible notes were automatically
converted into 1,237,293 shares of common stock and 2,338,576 units comprised of
4,677,152 shares of common stock and 2,841,603 warrants at an exercise price of
$3.4375.
16
Net
Cash Used in Operating Activities
Net cash
used in operating activities was $2,429,847 for the nine months ended September
30, 2010. The net loss of $9,402,433 for the nine months ended
September 30, 2010 was higher than cash used in operating activities by
$6,972,586. The primary reasons for the difference are the stock
issued in connection with our license agreements’ anti-dilution provision of
stock issuances of $2,587,576, the charge for the beneficial
conversion feature related to the Third Bridge Notes of $1,137,762, non-cash
interest expense of $462,430 on our outstanding debt during the first quarter of
2010, the write-offs of debt discount and deferred financing costs of $1,135,076
and $358,495, respectively, as a result of the conversion of our notes,
stock-based compensation charges of $816,010, an increase in accrued expenses of
$345,808 relating primarily to clinical research organization consultant costs,
patent fees, and accrued legal, accounting and filing fees.
Net
Cash Used in Investing Activities
Net cash
used in investing activities was $10,361 for the nine months ended September 30,
2010. Net cash used in investing activities consisted of leasehold
improvements made to our corporate headquarters located in Bridgewater, New
Jersey, in addition to purchases of computer equipment and accounting software,
which are being amortized over the term of the lease and the expected life of
the equipment and software. Net cash used in investing activities was
$0 for the nine months ended September 30, 2009.
Net
Cash Provided by Financing Activities
Net cash
provided by financing activities was $10,457,270 for the nine months ended
September 30, 2010. Net cash provided by financing activities
consisted of the sale of equity securities issued in our IPO, through which we
received gross proceeds of $12,512,500. The gross proceeds of
$12,512,500 were offset by underwriting discounts and commissions of $1,063,563,
corporate finance fees of $225,250, and reimbursable legal fees for counsel to
the underwriters of $90,000, in addition to other offering costs and expenses of
$676,417, consisting primarily of legal, accounting, printing and filing
fees. Net cash provided by financing activities was $105,365 for the
nine months ended September 30, 2009.
Funding
Requirements
Our total
cash on hand as of September 30, 2010 was $9,522,241, compared to $1,505,179 at
December 31, 2009. Because our business does not generate
positive operating cash flow, we will need to either raise additional capital
before we exhaust our current cash resources in order to continue to fund our
research and development, including our long-term plans for clinical trials and
new product development, as well as to fund operations generally. Our
continued operations will depend on whether we are able to raise additional
funds through various potential sources, such as equity, debt financing,
strategic relationships, or out-licensing of our products. Through
September 30, 2010, all of our financing has been through our recent IPO and
previous debt financings.
We will
continue to fund operations from cash on hand and through the similar sources of
capital previously described, or through other sources that may be dilutive to
existing stockholders. Moreover, the incurrence of indebtedness in
connection with a debt financing would result in increased fixed obligations and
could also result in covenants that would restrict our operations. We can give
no assurances that we will be able to secure such additional financing, or if
available, it will be sufficient to meet our needs.
17
Our
actual cash requirements may vary materially from those now planned, however,
because of a number of factors including the changes in the focus and direction
of our research and development programs, including the acquisition and pursuit
of development of new product candidates; competitive and technical advances;
costs of commercializing any of the product candidates; and costs of filing,
prosecuting, defending and enforcing any patent claims and any other
intellectual property rights.
We do not
anticipate that we will generate product revenue for at least the next several
years. In the absence of additional funding, we expect our continuing operating
losses to result in increases in our cash used in operations over the next
several quarters and years.
Based on
our cash resources at September 30, 2010, and our current plan of expenditure on
continuing development of our current products, we believe that we have
sufficient capital to fund our operations until the end of the first quarter of
2012, and will need additional financing until we can achieve profitability, if
ever. If we are unable to raise additional funds when needed, we may
not be able to market our products as planned or continue development and
regulatory approval of our products, or we could be required to delay, scale
back or eliminate some or all of our research and development
programs. Each of these alternatives would likely have a material
adverse effect on the prospects of our business.
Critical
Accounting Policies
Our
management’s discussion and analysis of our financial condition and results of
operations is based on our financial statements, which have been prepared in
accordance with accounting principles generally accepted in the United States,
or GAAP. The preparation of these financial statements requires us to
make estimates and judgments that affect the reported amounts of assets,
liabilities and expenses. On an ongoing basis, we evaluate these
estimates and judgments, including those described below. We base our
estimates on our historical experience and on various other assumptions that we
believe to be reasonable under the circumstances. These estimates and
assumptions form the basis for making judgments about the carrying values of
assets and liabilities that are not readily apparent from other
sources. Actual results and experiences may differ materially from
these estimates.
While our
significant accounting policies are more fully described in our Prospectus filed
pursuant to Rule 424(b) under the Securities Act with the SEC on March 26, 2010,
we believe that the following accounting policies are the most critical to aid
you in fully understanding and evaluating our reported financial results and
affect the more significant judgments and estimates that we use in the
preparation of our financial statements.
Stock-Based
Compensation
We
account for stock options according to the Financial Accounting Standards Board
Accounting Standards Codification No. 718, “Compensation — Stock
Compensation” (“ASC 718”). Under ASC 718, share-based compensation
cost is measured at grant date, based on the estimated fair value of the award,
and is recognized as expense over the employee’s requisite service period on a
straight-line basis.
We
account for stock options granted to non-employees on a fair value basis using
the Black-Scholes option pricing method in accordance with ASC
718. The non-cash charge to operations for non-employee options with
vesting are revalued at the end of each reporting period based upon the change
in the fair value of the options and amortized to consulting expense over the
related vesting period.
18
For the
purpose of valuing options and warrants granted to our employees, non-employees
and directors and officers during the nine months ended September 30, 2010, we
used the Black-Scholes option pricing model. We granted options to
purchase 1,639,215 shares of common stock to our employees, non-employees and
directors and officers during the nine months ended September 30,
2010. No options were issued during the nine months ended September
30, 2009. To determine the risk-free interest rate, we utilized the
U.S. Treasury yield curve in effect at the time of grant with a term consistent
with the expected term of our awards. We estimated the expected term
of the options granted based on anticipated exercises in future periods assuming
the success of our business model as currently forecasted. The
expected dividend yield reflects our current and expected future policy for
dividends on our common stock. The expected stock price volatility
for our stock options was calculated by examining historical volatilities for
publicly traded industry peers, although we do not have any trading history for
our common stock. We will continue to analyze the expected stock
price volatility and expected term assumptions as more historical data for our
common stock becomes available. Given that the stock options
currently outstanding are primarily held by our senior management and directors,
we do not currently expect to experience any forfeitures with respect to such
options and, as such, compensation expense for stock-based awards does not
include an estimate for forfeitures.
Off-Balance
Sheet Arrangements
We do not
have any off-balance sheet arrangements.
Item
3.
|
Quantitative
and Qualitative Disclosures About Market
Risk.
|
Not
applicable.
Item
4.
|
Controls
and Procedures.
|
Evaluation
of Disclosure Controls and Procedures
As of the
end of the period covered by this report, our management, including our
principal executive officer and principal financial officer, evaluated the
effectiveness of our disclosure controls and procedures (as defined in Rules
13a-15(e) and 15d-15(e) under the Exchange Act). Based on their evaluation of
our disclosure controls and procedures, our management, including our principal
executive officer and principal financial officer, have concluded that our
disclosure controls and procedures were effective as of September 30, 2010 to
ensure that information required to be disclosed by us in the reports that we
file or submit under the Exchange Act is (a) recorded, processed, summarized and
reported within the time periods specified in the SEC’s rules and forms and (b)
accumulated and communicated to management, including our principal executive
officer and principal financial officer, as appropriate to allow for timely
decisions regarding required disclosure.
Changes
in Internal Control Over Financial Reporting
During
the three months ended September 30, 2010, there were no changes in our internal
controls over financial reporting, or in other factors that could significantly
affect these controls, that materially affected, or are reasonably likely to
materially affect, our internal control over financial reporting.
19
PART
II
OTHER
INFORMATION
Item
1.
|
Legal
Proceedings.
|
None.
Item
1A.
|
Risk
Factors.
|
There are
no material changes from the risk factors previously disclosed in our Prospectus
filed pursuant to Rule 424(b) under the Securities Act with the SEC on
March 26, 2010.
Item
2.
|
Unregistered
Sales of Equity Securities and Use of
Proceeds.
|
Use
of Proceeds
Our IPO
was effected through a Registration Statement on Form S-1, as amended
(Registration No. 333-163380), that was declared effective by the SEC on March
24, 2010. The net offering proceeds to us, after deducting
underwriting discounts, commissions and offering expenses payable by us, were
approximately $10.5 million. No offering expenses were paid directly
or indirectly to any of our directors or officers (or their associates) or
persons owning ten percent or more of any class of our equity securities or to
any other affiliates. Of the net proceeds of $10.5 million, we have
used approximately $1.2 million for R&D expenditures and approximately $1.4
million for general working capital expenditures through the end of the third
quarter of 2010. We have invested the unused proceeds from the IPO in
an interest bearing savings account.
Item
3.
|
Defaults
Upon Senior Securities.
|
None.
Item
4.
|
(Removed
and Reserved).
|
Item
5.
|
Other
Information.
|
None.
Item
6.
|
Exhibits.
|
The
following is a list of exhibits filed as part of this Form 10-Q:
Exhibit
Number
|
Description
|
31.1
|
Certification
of Principal Executive Officer pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002.*
|
31.2
|
Certification
of Principal Financial Officer pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002.*
|
32.1
|
Certification
of Principal Executive Officer pursuant to 18 U.S.C. Section 1350, as
adopted pursuant to Section 906 of the Sarbanes-Oxley Act of
2002.*
|
32.2
|
Certification
of Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as
adopted pursuant to Section 906 of the Sarbanes-Oxley Act of
2002.*
|
20
_____________
*
|
Filed
herewith.
|
21
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, as amended, the
registrant has duly caused this report to be signed on its behalf by the
undersigned thereunto duly authorized.
CORMEDIX
INC.
|
|||
Date: November
8, 2010
|
By:
|
/s/
John C. Houghton
|
|
Name:
|
John
C. Houghton
|
||
Title:
|
President
and Chief Executive Officer
|
||
(Principal
Executive Officer)
|
|||
Date: November
8, 2010
|
By:
|
/s/
Brian Lenz
|
|
Name:
|
Brian
Lenz
|
||
Title:
|
Chief
Financial Officer
|
||
(Principal
Financial and Accounting
Officer)
|
22
EXHIBIT
INDEX
Exhibit
Number
|
Description
|
31.1
|
Certification
of Principal Executive Officer pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002.*
|
31.2
|
Certification
of Principal Financial Officer pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002.*
|
32.1
|
Certification
of Principal Executive Officer pursuant to 18 U.S.C. Section 1350, as
adopted pursuant to Section 906 of the Sarbanes-Oxley Act of
2002.*
|
32.2
|
Certification
of Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as
adopted pursuant to Section 906 of the Sarbanes-Oxley Act of
2002.*
|
_____________
*
|
Filed
herewith.
|
23