SEELOS THERAPEUTICS, INC. - Quarter Report: 2007 September (Form 10-Q)
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
DC 20549
FORM
10-Q
x |
Quarterly
report pursuant to Section 13 or 15(d) of the Securities Exchange
Act of
1934 for the quarterly period ended September 30,
2007.
|
Commission
file number 0-22245
NEXMED,
INC.
|
(Exact
Name of Issuer as Specified in Its
Charter)
|
Nevada
|
87-0449967
|
|
(State
or Other Jurisdiction of
|
(I.R.S.
Employer
|
|
Incorporation
or Organization)
|
Identification
No.)
|
89
Twin Rivers Drive, East Windsor, NJ 08520
|
(Address
of Principal Executive Offices)
|
(609)
371-8123
|
(Issuer’s
Telephone Number, Including Area
Code)
|
Indicate
by check mark whether the registrant: (1) has filed all reports required
to be
filed by Section 13 or 15 (d) of the Exchange Act 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 x
No
o
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, or a non-accelerated filer. See definition of “accelerated
filer” and “large accelerated filer” in Rule 12b-2 of the Exchange Act. (Check
one):
Large
accelerated filer o
|
Accelerated
filer o
|
Non-accelerated
filer x
|
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act). Yes o No x
Indicate
the number of shares outstanding of each of the issuer’s classes of common
equity, as of the latest practicable date: as of November
9, 2007, 82,906,867 shares of Common Stock, par value $0.001 per share, were
outstanding.
Table
of
Contents
Page
|
||
Part
I. FINANCIAL INFORMATION
|
1
|
|
Item
1.
|
Financial
Statements
|
1
|
Consolidated
Balance Sheets at September 30, 2007 (unaudited) and December 31,
2006
|
1
|
|
Unaudited
Consolidated Statements of Operations for the Three and Nine Months
Ended
September 30, 2007 and September 30, 2006
|
2
|
|
Unaudited
Consolidated Statements of Cash Flows for the Nine Months Ended
September
30, 2007 and September 30, 2006
|
3
|
|
Notes
to Unaudited Consolidated Financial Statements
|
4
|
|
Item
2.
|
Management's
Discussion and Analysis of Financial Condition and Results of
Operations
|
15
|
Item
3.
|
Quantitative
and Qualitative Disclosures about Market Risk
|
26
|
Item
4.
|
Controls
and Procedures
|
26
|
Part
II. OTHER INFORMATION
|
26
|
|
Item
1.
|
Legal
Proceedings
|
26
|
Item
1A.
|
Risk
Factors
|
27
|
Item
2.
|
Unregistered
Sales of Equity Securities and Use of Proceeds
|
27
|
Item
6.
|
Exhibits
|
28
|
Signatures
|
29
|
|
Exhibit
Index
|
30
|
PART
I. FINANCIAL INFORMATION
ITEM
1. FINANCIAL STATEMENTS
NexMed,
Inc.
Consolidated
Balance Sheets
September 30,
|
December 31,
|
||||||
2007
|
2006
|
||||||
(Unaudited)
|
|||||||
Assets
|
|||||||
Current
assets:
|
|||||||
Cash
and cash equivalents
|
$
|
1,957,313
|
$
|
11,069,133
|
|||
Short
term investments
|
1,000,000
|
1,000,000
|
|||||
Other
receivable
|
-
|
183,700
|
|||||
Debt
issuance cost, net of accumulated amortization of $58,786 and
$36,752
|
5,769
|
27,803
|
|||||
Prepaid
expenses and other assets
|
1,146,774
|
164,898
|
|||||
Total
current assets
|
4,109,856
|
12,445,534
|
|||||
Fixed
assets, net
|
7,079,464
|
7,488,100
|
|||||
Total
assets
|
$
|
11,189,320
|
$
|
19,933,634
|
|||
Liabilities,
convertible preferred stock and stockholders' equity
|
|||||||
Current
liabilities:
|
|||||||
Accounts
payable and accrued expenses
|
$
|
654,562
|
$
|
587,750
|
|||
Deferred
revenue
|
846,959
|
1,693,917
|
|||||
Payroll
related liabilities
|
100,886
|
156,567
|
|||||
Deferred
compensation - current portion
|
60,212
|
60,212
|
|||||
Convertible
notes payable - current portion
|
-
|
3,000,000
|
|||||
Note
payable, net of debt discount of $31,846 and $127,385
|
1,968,154
|
1,872,615
|
|||||
Total
current liabilities
|
3,630,773
|
7,371,061
|
|||||
Long
Term liabilities:
|
|||||||
Deferred
compensation
|
1,017,400
|
1,058,098
|
|||||
Total
Liabilities
|
4,648,173
|
8,429,159
|
|||||
Commitments
and contingencies (Note 10)
|
|||||||
Stockholders'
equity:
|
|||||||
Common
stock, $.001 par value, 120,000,000 shares
authorized, 82,806,867 and 80,285,905 and outstanding,
respectively
|
82,809
|
80,287
|
|||||
Additional
paid-in capital
|
138,291,516
|
137,164,658
|
|||||
Accumulated
other comprehensive loss
|
(9,596
|
)
|
(9,596
|
)
|
|||
Accumulated
deficit
|
(131,823,582
|
)
|
(125,730,874
|
)
|
|||
Total
stockholders' equity
|
6,541,147
|
11,504,475
|
|||||
Total
liabilities and stockholder's equity
|
$
|
11,189,320
|
$
|
19,933,634
|
See
notes
to unaudited consolidated financial statements.
1
NexMed,
Inc.
Consolidated
Statements of Operations
and
Comprehensive Income (Unaudited)
FOR THE THREE MONTHS
|
FOR THE NINE MONTHS ENDED
|
||||||||||||
ENDED
SEPTEMBER 30,
|
SEPTEMBER
30,
|
||||||||||||
2007
|
2006
|
2007
|
2006
|
||||||||||
Revenues,
principally license fee revenue
|
$
|
296,390
|
$
|
446,268
|
$
|
866,766
|
$
|
1,433,870
|
|||||
Operating
expenses
|
|||||||||||||
General
and administrative
|
1,037,421
|
1,079,807
|
3,414,246
|
3,988,395
|
|||||||||
Research
and development
|
1,266,792
|
1,332,351
|
3,459,390
|
3,925,827
|
|||||||||
Total
operating expenses
|
2,304,213
|
2,412,158
|
6,873,636
|
7,914,222
|
|||||||||
Loss
from operations
|
(2,007,823
|
)
|
(1,965,890
|
)
|
(6,006,870
|
)
|
(6,480,352
|
)
|
|||||
Other
Income (expense)
|
|||||||||||||
Interest
expense, net
|
(54,555
|
)
|
(21,945
|
)
|
(85,838
|
)
|
(64,082
|
)
|
|||||
Other
income
|
-
|
-
|
-
|
627,455
|
|||||||||
Total
Other income (expense)
|
(54,555
|
)
|
(21,945
|
)
|
(85,838
|
)
|
563,373
|
||||||
Net
loss
|
$ |
(2,062,378
|
)
|
$ |
(1,987,835
|
)
|
$ |
(6,092,708
|
)
|
$ |
(5,916,979
|
)
|
|
Deemed
dividend to preferred shareholders from beneficial conversion
feature
|
0
|
-
|
0
|
(49,897
|
)
|
||||||||
Preferred
dividend
|
0
|
-
|
0
|
(15,264
|
)
|
||||||||
Net
loss applicable to common stock
|
$ |
(2,062,378
|
)
|
$ |
(1,987,835
|
)
|
$ |
(6,092,708
|
)
|
$ |
(5,982,140
|
)
|
|
Basic
and diluted loss per common share
|
$
|
(0.02
|
)
|
$
|
(0.03
|
)
|
$
|
(0.07
|
)
|
$
|
(0.09
|
)
|
|
Weighted
average common shares outstanding used for basic and diluted
loss per
share
|
82,700,287
|
66,643,197
|
81,710,215
|
65,299,502
|
See
notes
to unaudited consolidated financial statements.
2
NexMed,
Inc.
Consolidated
Statements of Cash Flows (Unaudited)
FOR THE NINE MONTHS ENDED
|
|||||||
SEPTEMBER 30,
|
|||||||
2007
|
2006
|
||||||
Cash
flows from operating activities
|
|||||||
Net
loss
|
$
|
(6,092,708
|
)
|
$
|
(5,916,979
|
)
|
|
Adjustments
to reconcile net loss to net cash used in operating
activities
|
|||||||
Depreciation
and amortization
|
488,238
|
655,470
|
|||||
Non-cash
interest, amortization of debt discount and deferred financing
costs
|
308,321
|
160,175
|
|||||
Non-cash
compensation expense
|
736,049
|
920,632
|
|||||
Loss
on disposal of fixed assets
|
7,911
|
454,105
|
|||||
Decrease
(increase) in other receivable
|
183,700
|
398,740
|
|||||
(Increase)
decrease in prepaid expenses and other assets
|
(981,876
|
)
|
42,441
|
||||
Decrease
in accounts payable and accrued expenses
|
66,812
|
29,879
|
|||||
Decrease
in payroll related liabilities
|
(55,681
|
)
|
(1,053,668
|
)
|
|||
Decrease
in deferred compensation
|
(40,698
|
)
|
(45,805
|
)
|
|||
Decrease
in deferred revenue
|
(846,958
|
)
|
(843,913
|
)
|
|||
Net
cash used in operating activities
|
(6,226,891
|
)
|
(5,198,923
|
)
|
|||
Cash
flows from investing activities
|
|||||||
Proceeds
from sale of fixed assets
|
-
|
178,769
|
|||||
Capital
expenditures
|
(87,512
|
)
|
(70,078
|
)
|
|||
Purchase
of marketable securities and short term investments
|
(3,000,000
|
)
|
(6,000,000
|
)
|
|||
Proceeds
from sale of marketable securities and short term
investments
|
3,000,000
|
4,500,000
|
|||||
Net
cash used in investing activities
|
(87,512
|
)
|
(1,391,309
|
)
|
|||
Cash
flows from financing activities
|
|||||||
Issuance
of common stock, net of offering costs of $2,110 in 2007 and
$571,193 in
2006
|
(2,110
|
)
|
7,747,808
|
||||
Proceeds
from exercise of stock options and warrants
|
204,692
|
97,316
|
|||||
Repayment
of capital lease obligations
|
-
|
(213,744
|
)
|
||||
Repayment
of convertible notes payable
|
(3,000,000
|
)
|
-
|
||||
Net
cash (used in) provided by financing activities
|
(2,797,418
|
)
|
7,631,380
|
||||
Net
(decrease) increase in cash and cash equivalents
|
(9,111,820
|
)
|
1,041,148
|
||||
Effect
of foreign exchange on cash and cash equivalents
|
-
|
3
|
|||||
Cash
and cash equivalents, beginning of period
|
$
|
11,069,133
|
$
|
2,953,781
|
|||
Cash
and cash equivalents, end of period
|
$
|
1,957,313
|
$
|
3,994,932
|
See
notes
to unaudited consolidated financial statements.
3
NexMed,
Inc.
Notes
to Unaudited
Consolidated
Financial Statements
1. BASIS
OF
PRESENTATION
The
accompanying unaudited consolidated financial statements have been prepared
in
accordance with accounting principles generally accepted in the United States
of
America for interim financial information and with the instructions to Form
10-Q
and Article 10-01 of Regulation S-X. Accordingly, they do not include all of
the
information and footnotes required by accounting principles generally accepted
in the United States of America for annual financial statements. In the opinion
of management, all adjustments (consisting of normal recurring accruals)
considered necessary for a fair statement have been included. Operating results
for the nine months ended September 30, 2007 are not necessarily indicative
of
the results that may be expected for the year ended December 31, 2007. These
financial statements should be read in conjunction with the financial statements
and notes thereto contained in NexMed, Inc.’s (the “Company”) Annual Report on
Form 10-K for the year ended December 31, 2006.
The
Company had an accumulated deficit of $131,823,582 at September 30, 2007 and
the
Company expects to incur additional losses during the remainder of 2007. As
a
result of our losses to date and accumulated deficit, there is doubt as to
our
ability to continue as a going concern, and, accordingly, our independent
registered public accounting firm has modified its report on our December 31,
2006 consolidated financial statements included in our Annual Report on Form
10-K in the form of an explanatory paragraph describing the events that have
given rise to this uncertainty. Management plans to obtain additional financing
through additional partnering agreements for its products under development
using the NexACT®
technology. If the Company is successful in entering into such additional
partnering agreements, it anticipates that it may receive milestone payments,
which would offset some of its research and development expenses. Although
management continues to pursue these plans, there is no assurance that the
Company will be successful in obtaining financing on terms acceptable to it.
If
additional financing cannot be obtained on reasonable terms, future operations
will need to be scaled back or discontinued. These financial statements do
not
include any adjustments that might result from the outcome of this
uncertainty.
In
June
2006, the FASB issued FASB Interpretation No. ("FIN") 48 "Accounting for
Uncertainty in Income Taxes" ("FIN48"). FIN 48 sets forth a recognition
threshold and measurement attribute for financial statement recognition of
positions taken or expected to be taken in income tax returns. The required
adoption of FIN 48 as of January 1, 2007 had no material impact on the Company's
consolidated financial statements. The tax years 2003-2006 remain open to
examination by the major taxing jurisdictions to which we are
subject.
4
2.
ACCOUNTING
FOR STOCK BASED COMPENSATION
During
December 1996, the Company adopted the NexMed, Inc. Stock Option and Long-Term
Incentive Compensation Plan (“the Incentive Plan”) and the NexMed, Inc.
Recognition and Retention Stock Incentive Plan (“the Recognition Plan”). A total
of 2,000,000 shares were set aside for these two plans. In May 2000, the
Stockholders approved an increase in the number of shares reserved for the
Incentive Plan and Recognition Plan to a total of 7,500,000. During June 2006,
the Company adopted the NexMed, Inc. 2006 Stock Incentive Plan. A total of
3,000,000 shares were set aside for the plan. Options granted under the
Company’s plans generally vest over a period of one to five years, with exercise
prices of currently outstanding options ranging from $0.55 to $16.25. The
maximum term under these plans is 10 years.
Effective
January 1, 2006, the Company adopted the provisions of Statement of Financial
Accounting Standards No. 123R, “Share-Based Payment” (“SFAS
123R”), which establishes the financial accounting and reporting standards
for stock-based compensation plans. SFAS 123R requires the measurement and
recognition of compensation expense for all stock-based awards made to employees
and directors, including employee stock options and restricted stock. Under
the
provisions of SFAS 123R, stock-based compensation cost is measured at the
grant date, based on the calculated fair value of the award, and is recognized
as an expense on a straight-line basis over the
requisite service period of the entire award (generally the vesting period
of
the award). The Company adopted the provisions of SFAS 123R as of January 1,
2006 using the modified prospective transition method. Under this transition
method, stock-based compensation expense for the three and nine months ended
September 30, 2007 and September 30, 2006 includes expense for all equity awards
granted during the three and nine months ended September 30, 2007 and prior,
but
not yet vested as of January 1, 2006, based on the grant date fair value
estimated in accordance with the original provisions of SFAS No. 123,
“Accounting for Stock-Based Compensation” (“SFAS 123,”) as amended by SFAS 148,
“Accounting for Stock-Based Compensation—Transition and Disclosure.” Also in
accordance with the modified prospective transition method, prior interim and
annual periods have not been restated and do not reflect the recognition of
stock-based compensation cost under SFAS 123R. Since the adoption of SFAS 123R,
there have been no changes to the Company’s stock compensation plans or
modifications to outstanding stock-based awards which would increase the value
of any awards outstanding. Compensation expense for all stock-based compensation
awards granted subsequent to January 1, 2006 was based on the grant-date fair
value determined in accordance with the provisions of SFAS 123R.
As
a
result of adopting SFAS 123R, the Company’s net loss and its non cash
compensation expense as shown in the Consolidated Statements of Operations
for
the three and nine months ended September 30, 2007 and September 30, 2006 is
more by $167,641, $676,049 and $193,065, $812,632, respectively, than if the
Company had continued to account for stock-based compensation under Accounting
Principles Board Opinion No. 25, “Accounting for Stock Issued to Employees”
(“APB 25”) and its related interpretations. Basic and diluted net loss per share
for the three and nine months ended September 30, 2007 and September 30, 2006
is
more by $0.002, $0.008 and $0.003, $0.01, respectively, than if the Company
had
not adopted SFAS 123R.
5
The
following table indicates where the total stock-based compensation expense
resulting from stock options and awards appears in the Statement of Operations
(unaudited):
FOR THE THREE MONTHS
|
FOR THE NINE MONTHS ENDED
|
||||||||||||
ENDED SEPTEMBER 30,
|
SEPTEMBER 30,
|
||||||||||||
2007
|
2006
|
2007
|
2006
|
||||||||||
General
and administrative
|
$
|
163,409
|
$
|
203,385
|
$
|
640,764
|
$
|
880,422
|
|||||
Research
and development
|
4,232
|
25,680
|
35,285
|
40,210
|
|||||||||
Stock-based
compensation expense
|
$
|
167,641
|
$
|
229,065
|
$
|
676,049
|
$
|
920,632
|
The
stock-based compensation expense has not been tax-effected due to the recording
of a full valuation allowance against U.S. net deferred tax assets.
The
Company accounts for stock and stock options granted to non-employees on a
fair
value basis in accordance with SFAS No. 123, "Accounting for Stock-Based
Compensation," and Emerging Issues Task Force Issue No. 96-18, "Accounting
for
Equity Instruments That Are Issued to Other Than Employees for Acquiring, or
in
Conjunction with Selling, Goods or Services." Any stock or stock options issued
to non-employees are recorded in the consolidated financial statements using
the
fair value method and then amortized to expense over the applicable service
periods. As a result, the non-cash charge to operations for non-employee options
with vesting or other performance criteria is valued each reporting period
based
upon changes in the fair value of the Company's common stock.
During
the nine months ended September 30, 2007, the Company issued 60,000 shares
of
its common stock in payment for services rendered by a consultant. Accordingly,
the Company recorded $60,000 to general and administrative expenses in the
Statement of Operations based on the fair value of its common stock on the
date
of issuance.
The
fair
value of each stock option grant is estimated on the grant date using the
Black-Scholes option-pricing model with the following assumptions used for
the
three and nine months ended September 30, 2007 and 2006:
Dividend
yield
|
0.00
|
%
|
||
Risk-free
yields
|
4.15%
- 4.47
|
%
|
||
Expected
volatility
|
80%
- 105
|
%
|
||
Expected
option life
|
6
years
|
Expected
Volatility.
The
Company uses analysis of historical volatility to compute the expected
volatility of its stock options.
Expected
Term. The
expected term is based on several factors including historical observations
of
employee exercise patterns during the Company’s history and expectations of
employee exercise behavior in the future giving consideration to the contractual
terms of the stock-based awards.
6
Risk-Free
Interest Rate.
The
interest rate used in valuing awards is based on the yield at the time of grant
of a U.S. Treasury security with an equivalent remaining term.
Dividend
Yield.
The
Company has never paid cash dividends, and does not currently intend to pay
cash
dividends, and thus has assumed a 0% dividend yield.
Pre-Vesting
Forfeitures.
Estimates of pre-vesting option forfeitures are based on Company experience.
The
Company will adjust its estimate of forfeitures over the requisite service
period based on the extent to which actual forfeitures differ, or are expected
to differ, from such estimates. Changes in estimated forfeitures will be
recognized through a cumulative catch-up adjustment in the period of change
and
will also impact the amount of compensation expense to be recognized in future
periods. The cumulative effect resulting from initially applying the provisions
of SFAS 123R to nonvested equity awards was not significant. The Company’s
current forfeiture rate is 6.41%.
Stock
Options and Restricted Stock
Presented
below is a summary of the status of Company stock options as of September 30,
2007, and related transactions for the nine months then ended (unaudited):
Weighted
|
Weighted
|
Total
|
|||||||||||
Average
|
Average Remaining
|
Aggregate
|
|||||||||||
Number of
|
Exercise
|
Contractual
|
Intrinsic
|
||||||||||
Shares
|
Price
|
Term
|
Value
|
||||||||||
Outstanding
at December 31, 2006
|
3,663,421
|
||||||||||||
Granted
|
27,100
|
$
|
1.28
|
||||||||||
Exercised
|
(58,480
|
)
|
$
|
0.96
|
|||||||||
Forfeited
|
(317,200
|
)
|
$
|
2.82
|
|||||||||
Outstanding
at September 30, 2007
|
3,314,841
|
$
|
1.41
|
7.42
years
|
$
|
2,279,888
|
|||||||
Vested
or expected to vest at September 30, 2007
|
3,102,360
|
$
|
1.41
|
7.42
years
|
$
|
2,133,747
|
|||||||
Exercisable
at September 30, 2007
|
2,801,741
|
$
|
1.50
|
7.24
years
|
$
|
1,889,346
|
7
Options
Outstanding
|
Options
Exercisable
|
||||||||||||||||||||||
Weighted Average
|
Aggregate
|
Aggregate
|
|||||||||||||||||||||
Range of
|
Number
|
Remaining
|
Weighted Average
|
Intrinsic
|
Number
|
Weighted Average
|
Intrinsic
|
||||||||||||||||
Exercise Prices
|
Outstanding
|
Contractual Life
|
Exercise Price
|
Value*
|
Exercisable
|
Exercise Price
|
Value*
|
||||||||||||||||
$
|
.55
- 1.85
|
2,779,390
|
7.83
years
|
$
|
0.83
|
$
|
2,279,888
|
2,266,290
|
$
|
0.82
|
$
|
1,889,346
|
|||||||||||
2.00
- 3.99
|
139,250
|
3.34
years
|
2.83
|
-
|
139,250
|
2.83
|
-
|
||||||||||||||||
4.00
- 5.50
|
374,301
|
4.76
years
|
4.65
|
-
|
374,301
|
4.76
|
-
|
||||||||||||||||
7.00
- 8.00
|
15,000
|
2.63
years
|
8.00
|
-
|
15,000
|
8.00
|
-
|
||||||||||||||||
12.00
- 16.25
|
6,900
|
3.02
years
|
14.40
|
-
|
6,900
|
14.40
|
-
|
||||||||||||||||
3,314,841
|
$
|
1.41
|
$
|
2,279,888
|
2,801,741
|
$
|
1.50
|
$
|
1,889,346
|
*Intrinsic
values are determined by comparing the aggregate exercise prices of options
to
the closing price of our Common Stock on September 30,
2007
The
weighted-average grant-date fair value of options granted during the nine months
ended September 30, 2007 and September 30, 2006 was $1.28 and $0.77,
respectively. The intrinsic value (the difference between the aggregate exercise
price and the closing price of our common stock on the date of exercise) on
the
exercise date of options exercised during the nine months ended September 30,
2007 and 2006 was $23,529 and $108,328, respectively. Cash received from option
exercises for the nine months ended September 30, 2007 and September 30, 2006,
was $56,164 and $97,316, respectively.
On
January 24, 2007, the Company issued awards of restricted shares of the
Company’s common stock to Richard Berman, Chief Executive Officer, Vivian Liu,
Chief Operating Officer, and Mark Westgate, Chief Financial Officer. Mr.
Berman’s award of 60,000 shares vests in four equal installments on March 31,
June 30, September 30, and December 31, 2007, assuming continuous and
uninterrupted service as Chief Executive Officer of the Company. Mr. Berman’s
30,000 unvested shares at June 30, 2007 were cancelled upon his resignation
as
CEO and the appointment of Ms. Liu to the position of CEO. Ms. Liu and Mr.
Westgate received awards of 150,000 and 75,000 restricted shares, respectively.
Ms. Liu and Mr. Westgate’s awards vest in three equal installments on December
31, 2007, 2008 and 2009, assuming continuous and uninterrupted service with
the
Company.
Also
on
January 24, 2007, the Company issued awards of shares of the Company’s common
stock to Board members Leonard Oppenheim, Martin Wade and Arthur Emil for their
services during their 2006 – 2007 terms. Mr. Oppenheim received an award of
25,000 shares for his service as Chairman of the Board of Directors. Mr. Wade
received an award of 10,000 shares for his service as Chairman of the Audit
Committee and Compensation Committee of the Board of Directors. Mr. Emil
received an award of 5,000 shares for his service as Chairman of the Corporate
Governance/Nominating Committee of the Board of Directors.
8
Additionally,
on April 1, June 28, and September 28, 2007 the Company issued awards of shares
of the Company’s common stock to each independent director as compensation for
their services during the quarters ended March 31, June 30, 2007 and September
30, 2007. Each independent director received 10,227 shares of common stock
for a
total of 51,135 shares issued on April 1, June 28, and September 28,
2007.
The
Company appointed Dr. David S. Tierney to the Board of Directors on January
24,
2007. In connection with his appointment to the Board, the Company issued an
award of restricted shares of the Company’s common stock as compensation for his
services as a member of the Board of Directors. The restricted stock award
of
30,000 shares vests in three equal installments on February 1, 2007 and on
the
dates of the Annual Meeting of Stockholders in 2007 and 2008 assuming continuous
and uninterrupted service with the Company.
On
September 12, 2007, the Company issued awards of shares of the Company’s common
stock to Board members Leonard Oppenheim, Martin Wade, Arthur Emil and David
Tierney for their services during their 2007 – 2008 terms. Mr. Oppenheim
received an award of 5,000 shares for his service as Chairman of the Finance
Committee of the Board of Directors. Mr. Wade received an award of 10,000 shares
for his service as Chairman of the Audit Committee and Compensation Committee
of
the Board of Directors. Mr. Emil received an award of 5,000 shares for his
service as Chairman of the Corporate Governance/Nominating Committee of the
Board of Directors. Dr. Tierney received an award of 20,000 shares for his
service as Chairman of the Company’s Scientific Advisory Board.
As
of
September 30, 2007, there was $306,478 of total unrecognized compensation cost
related to non-vested stock and stock options. That cost is expected to be
recognized over a weighted-average period of 1.48 years.
3. WARRANTS
A
summary
of warrant activity for the nine month period ended September 30, 2007 is as
follows:
Weighted
|
Weighted
|
|||||||||
Common Shares
|
Average
|
Average
|
||||||||
Issuable upon
|
Exercise
|
Contractual
|
||||||||
Exercise
|
Price
|
Life
|
||||||||
Outstanding
at December 31, 2006
|
20,125,027
|
$
|
1.33
|
2.49
yrs
|
||||||
Issued
|
-
|
-
|
||||||||
Exercised
|
(2,790,495
|
)
|
$
|
1.83
|
||||||
Cancelled
|
(5,344,578
|
)
|
$
|
1.40
|
||||||
Outstanding
at September 30, 2007
|
11,989,954
|
$
|
1.43
|
2.59
yrs
|
||||||
Exercisable
at September 30, 2007
|
11,989,954
|
$
|
1.43
|
2.59
yrs
|
9
Cash
received from warrant exercises for the nine months ended September 30, 2007
and
September 30, 2006, was $148,528 and $0, respectively. Additionally, warrants
to
purchase 2,663,400 shares of common stock were exercised during the nine months
ended September 30, 2007 under the cashless exercise provisions of the
applicable warrant agreement. As such, 1,512,368 net shares were issued to
the
warrant holder upon the cashless exercise.
4. LOSS
PER
SHARE
At
September 30, 2007 and 2006, respectively, options to acquire 3,314,841 and
3,183,745 shares of common stock with exercise prices ranging from $.55 to
$16.25 per share, warrants to acquire 13,010,786 and 14,304,894 shares of common
stock with exercise prices ranging from $0.55 to $3.00 and convertible
securities convertible into zero and 1,200,000 shares of common stock in 2007
and 2006, respectively, at a conversion price of $5.00 were excluded from the
calculation of diluted loss per share, as their effect would be anti-dilutive.
Loss per share for the three and nine months ended September 30, 2007 and 2006
was calculated as follows (net loss applicable to common stock / weighted
average common shares outstanding):
FOR THE THREE MONTHS
|
FOR THE NINE MONTHS ENDED
|
||||||||||||
ENDED SEPTEMBER 30,
|
SEPTEMBER 30,
|
||||||||||||
2007
|
2006
|
2007
|
2006
|
||||||||||
Net
loss applicable to common stock
|
$ |
(2,062,378
|
)
|
$ |
(1,987,835
|
)
|
$ |
(6,092,708
|
)
|
$ |
(5,982,140
|
)
|
|
Weighted
average common shares outstanding used for basic and diluted loss
per
share
|
82,700,287
|
66,643,197
|
81,710,215
|
65,299,502
|
|||||||||
Basic
and diluted loss per common share
|
$
|
(0.02
|
)
|
$
|
(0.03
|
)
|
$
|
(0.07
|
)
|
$
|
(0.09
|
)
|
5. CONVERTIBLE
NOTES PAYABLE
On
December 12, 2003, the Company issued convertible notes (the “Notes”) in an
aggregate principal amount of $6 million. The Notes were payable in two
installments of $3 million on November 30, 2006 and May 31, 2007 and were
collateralized by the Company’s facility in East Windsor, New Jersey. The Notes
were initially convertible into shares of the Company’s common stock at a
conversion price equal to $6.50 per share (923,077 shares). Pursuant to the
terms of the Notes, the conversion price was adjusted on June 14, 2004 to the
greater of (i) the volume weighted average price of the Company’s stock over the
six-month period ending on such date and (ii) $5.00. Since the volume weighted
average price of the Company’s stock during this period was below $5.00, the
conversion price was adjusted to $5.00 (1,200,000 shares). Interest accreted
on
the Notes on a semi-annual basis at a rate of 5% per annum, and the Company
could pay such amounts in cash or by effecting the automatic conversion of
such
amount into the Company’s common stock at a 5% premium to the then average
market prices.
10
On
November 30, 2006, the Company paid in cash the $3 million installment due
plus
accrued interest of $25,417.
In
April
2007, the Company issued 59,576 shares of its common stock as payment of an
aggregate of $75,833 in interest on the Notes.
On
May
31, 2007, the Company paid in cash the remaining $3 million balance due plus
accrued interest of $25,417. As of June 30, 2007, there was no remaining balance
due to the holders of the Notes.
6. NOTE
PAYABLE
On
November 30, 2006, the Company issued a Note in a principal amount of $2
million. The Note was payable on the earlier of December 31, 2007 or the closing
by the Company on the sale of the Company’s facility in East Windsor. Interest
accreted on the Note on a quarterly basis at a rate of 7.5% per annum provided,
however, if the Company had not entered into a contract of sale of the East
Windsor property on or prior to May 31, 2007, and the Note had not been repaid
by such date, the interest rate would increase to 8.5%. As such, on May 31,
2007, the interest rate increased to 8.5%.
The
Company also issued to the Note holder a 4-year detachable warrant to purchase
500,000 shares of common stock at an exercise price of $0.5535. The Company
valued the warrants using the Black-Scholes pricing model. The Company allocated
a relative fair value of $138,000 to the warrants. The relative fair value
of
the warrants was allocated to additional paid in capital and treated as a
discount to the Note that was being amortized over the 13-month period ending
December 31, 2007. The balance of the Note discount was expensed as interest
upon the Note being repaid on October 29, 2007.
On
February 28, 2007, the Company issued 28,809 shares of its common stock as
payment of an aggregate of $25,000 in interest on the Note.
On
May 1,
2007, the Company issued 30,711 shares of its common stock as payment of an
aggregate of $37,500 in interest on the Note.
On
August
1, 2007 the Company issued 26,518 shares of its common stock as payment of
an
aggregate of $40,833 in interest on the Note.
On
October 29, 2007, the Company paid in cash the $2 million balance on the Note
plus accrued interest of $42,028.
7.
DEFERRED
COMPENSATION
On
February 27, 2002, the Company entered into an employment agreement with Y.
Joseph Mo, Ph.D., that had a constant term of five years, and pursuant to which
Dr. Mo would serve as the Company's Chief Executive Officer and President.
Under
the employment agreement, Dr. Mo was entitled to deferred compensation in an
annual amount equal to one sixth of the sum of his base salary and bonus for
the
36 calendar months preceding the date on which the deferred compensation
payments commenced subject to certain limitations, including annual vesting
through January 1, 2007, as set forth in the employment agreement. The deferred
compensation is payable monthly for 180 months commencing on termination of
employment. Dr. Mo’s employment was terminated as of December 15, 2005. At such
date, the Company accrued deferred compensation of $1,178,197 based upon the
estimated present value of the obligation. The monthly deferred compensation
payment through May 15, 2021 will be $9,158. As of September 30, 2007 the
Company has accrued $1,077,612 in deferred compensation.
11
8. SERIES
C
6% CUMULATIVE CONVERTIBLE PREFERRED STOCK
On
May
17, 2005, the Company sold an aggregate of 445 shares of its Series C 6%
cumulative convertible preferred stock (the “Series C Stock”) and raised gross
proceeds of $4,450,000 ($10,000 liquidation preference per share). Each
preferred share of the Series C Stock was initially convertible at the holder’s
option into approximately 7,353 shares of common stock (total of 3,272,059
shares). Each investor also received for each share of Series C Stock purchased,
4-year detachable warrants to purchase 2,672 shares of common stock (total
of
1,188,931 warrants) at an exercise price of $1.43 per share. The Series C Stock
could be converted at any time, at the holder’s option, into shares of the
Company’s common stock at an initial conversion value of $1.36. The Company also
had the right to force conversion of the Series C Stock, under certain
circumstances, at the initial conversion value. Under the terms of the
certificate of designation of the Series C Stock, the Company agreed to redeem
at the liquidation preference per share or convert the Series C Stock on a
quarterly basis, subject, in each case, to reduction by previously converted
shares of Series C Stock, as follows: $2 million plus accrued dividends on
September 30, 2005, $1 million plus accrued dividends each on December 31,
2005
and September 30, 2006 and $450,000 plus accrued dividends on September 30,
2006.
On
June
30, 2006, pursuant to the terms of the Series C Stock, the Company converted
the
remaining 15.5 preferred shares and accrued dividends through June 30, 2006
of
$159,612 at a price of $0.65 per share. Upon conversion, the Company issued
a
total of 244,113 shares of common stock. As of June 30, 2007, no shares of
the
Series C Stock remained outstanding.
The
Company valued the warrants using the Black-Scholes pricing model. The Company
allocated a relative fair value of $799,844 to the warrants. The relative fair
value of the warrants was allocated to additional paid in capital and treated
as
a discount to the Series C Stock that would not be amortized until such time
as
the redemption for cash became probable. Therefore, the Company recorded a
deemed dividend to the shareholders of the Series C Stock in proportion to
the
amount redeemed at any time redemption for cash became probable. Assumptions
utilized in the Black-Scholes model to value the warrants were: exercise price
of $1.43 per share; fair value of the Company’s common stock on the date of
issuance of $1.33 per share; volatility of 80%; term of 4 years and a risk-free
interest rate of 3.97%.
The
allocated value of the Series C Stock contained a beneficial conversion feature
calculated based upon the difference between the effective conversion price
of
the proceeds allocated to the Series C Stock, and the fair market value of
the
common stock on the date of issuance. As a result, the Company recorded a deemed
dividend to the shareholders of the Series C Stock of $636,241 on the issuance
date, representing the value of the beneficial conversion feature of the Series
C Stock. As the Company had no retained earnings on the date of the deemed
dividend, the dividend was recorded as a reduction to additional paid in
capital.
12
The
Company also recorded a discount to the Series C Stock of $209,686 based on
a
contingent beneficial conversion feature which would arise because the Company
must adjust the conversion price to be equal to a 4.5% discount to the then
common stock price on each respective settlement date. The Company has amortized
this discount, which is treated as a deemed dividend, over the life of the
Series C Stock using the effective interest method. For the nine months ended
September 30, 2006, the Company recorded a deemed dividend to the shareholders
of the Series C Stock of $12,796 based on the amortization of the beneficial
conversion feature.
For
the
nine months ended September 30, 2006 pursuant to the terms of the Series C
Stock, the Company recorded dividends in the amount of $15,624 as a dividend
to
preferred shareholders in the Consolidated Statements of Operations.
The
Company incurred issuance costs associated with the preferred placement of
$230,031. The relative fair value of the issuance costs attributable to the
Series C Stock of $188,685 was accreted as a deemed dividend to the holders
of
the Series C Stock at such time conversion became probable. The relative fair
value of the issuance costs attributable to the warrants of $41,346 has been
recorded as an offset to additional paid in capital. For the nine months ended
September 30, 2006, the Company amortized $37,101 of the issuance costs as
a
deemed dividend to the preferred shareholders in the Consolidated Statements
of
Operations.
9. INCOME
TAXES
In
consideration of the Company’s accumulated losses and lack of historical ability
to generate taxable income, the Company has determined that it will not be
able
to realize any benefit from its temporary differences between book income and
taxable income in the foreseeable future, and has recorded a valuation allowance
of an equal amount to fully offset the deferred tax benefit amount.
10. COMMITMENTS
AND CONTINGENCIES
The
Company is a party to clinical research agreements in connection with a one-year
open-label study for its topical alprostadil-based cream treatment for erectile
dysfunction (“ED Product”) with commitments by the Company that initially
totaled approximately $12.8 million. These agreements were amended in October
2005 such that the total commitment was reduced to approximately $4.2 million.
These agreements provide that if the Company cancels them prior to 50%
completion, the Company will owe the higher of 10% of the outstanding contract
amount prior to the amendment or 10% of the outstanding amount of the amended
contract at the time of cancellation. At September 30, 2007, this amounts to
approximately $1.1 million. The Company anticipates that the clinical research
in connection with the agreements may be completed in 2008.
13
11. LICENSING
AGREEMENTS
On
September 15, 2005, the Company signed an exclusive global licensing agreement
with Novartis International Pharmaceutical Ltd., (“Novartis”) for its
anti-fungal product, NM100060. Under the agreement, Novartis acquired the
exclusive worldwide rights to NM100060 and would assume all further development,
regulatory, manufacturing and commercialization responsibilities as well as
costs. Novartis agreed to pay the Company up to $51 million in upfront and
milestone payments on the achievement of specific development and regulatory
milestones, including an initial cash payment of $4 million at signing. In
addition, the Company is eligible to receive royalties based upon the level
of
sales achieved and is entitled to receive reimbursements of third party
preclinical study costs up to $3.25 million. The Company is recognizing the
initial up front and preclinical reimbursement revenue from this agreement
based
on the cost-to-cost method over the 32-month period estimated to complete the
remaining preclinical studies for NM100060.
On
February 16, 2007, the Novartis agreement was amended. Pursuant to the
amendment, the Company is no longer obligated to complete the remaining
preclinical studies for NM100060. Novartis has taken over all responsibilities
related to the remaining preclinical studies. As such, the balance of deferred
revenue of $1,693,917 at December 31, 2006 is being recognized as revenue on
a
straight line basis over the 18 month period ended June 30, 2008 which is the
estimated performance period for Novartis to complete the remaining preclinical
studies. Accordingly, for the three and nine month period ended September 30,
2007, the Company recognized licensing revenue of $282,319 and $846,957,
respectively, related to the Novartis agreement.
12. SUBSEQUENT
EVENTS
On
October 26, 2007 the Company issued a Note in a principal amount of $3 million.
The Note is payable on June 30, 2009 and can be prepaid by the Company at any
time without penalty. Interest accretes on the Note on a quarterly basis at
a
rate of 8.0% per annum.
The
Company also issued to the Note holder a 5-year detachable warrant to purchase
450,000 shares of common stock at an exercise price of $1.52. Of the total
warrants issued, 350,000 warrants vest immediately and the remaining 100,000
warrants will vest if the Note remains outstanding on October 26, 2008.
The
Note
is collateralized by the Company’s facility in East Windsor, New Jersey. The
Company terminated an earlier agreement of sale for the Company’s East Windsor
facility due to a breach by the buyer.
On
November 1, 2007, the Company signed an exclusive licensing agreement with
Warner Chilcott Company, Inc., (“Warner”) for its topical alprostadil-based
cream treatment for erectile dysfunction (“ED Product”). Under the agreement,
Warner acquired the exclusive rights in the United States to the ED Product
and
will assume all further development, manufacturing, and commercialization
responsibilities as well as costs. Warner agreed to pay the Company an up front
payment of $500,000 and up to $12.5 million in milestone payments on the
achievement of specific regulatory milestones. In addition, the Company is
eligible to receive royalties based upon the level of sales achieved.
14
ITEM 2. |
MANAGEMENT'S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
OPERATIONS
|
Disclosures
Regarding Forward-Looking Statements.
The
following should be read in conjunction with the unaudited consolidated
financial statements and the related notes that appear elsewhere in this
document. This report includes forward-looking statements made based on current
management expectations pursuant to the safe harbor provisions of the Private
Securities Litigation Reform Act of 1995. These statements are not guarantees
of
future performance and actual outcomes may differ materially from what is
expressed or forecast. There are many factors that affect our business,
consolidated financial position, results of operations and cash flows, including
but not limited to, our ability to enter into partnering agreements or raise
financing on acceptable terms, successful completion of clinical development
programs, regulatory review and approval, product development and acceptance,
manufacturing, competition, and/or other factors, many of which are outside
our
control.
General.
We
are a
Nevada corporation and have been in existence since 1987. Since 1994, we have
positioned ourselves as a pharmaceutical and medical technology company with
a
focus on developing and commercializing therapeutic products based on
proprietary delivery systems. We are currently focusing our efforts on new
and
patented topical pharmaceutical products based on a penetration enhancement
drug
delivery technology known as NexACT®,
which
may enable an active drug to be better absorbed through the skin.
The
NexACT®
transdermal drug delivery technology is designed to enhance the absorption
of an
active drug through the skin, overcoming the skin's natural barrier properties
and enabling high concentrations of the active drug to rapidly penetrate the
desired site of the skin or extremity. Successful application of the
NexACT®
technology would improve therapeutic outcomes and reduce systemic side effects
that often accompany oral and injectable medications. We have applied the
NexACT®
technology to a variety of compatible drug compounds and delivery systems,
and
on our own or through development partnerships are in various stages of
developing new topical treatments for sexual dysfunction, nail fungus and other
dermatological conditions. We intend to continue our efforts developing topical
treatments based on the application of NexACT®
technology to drugs: (1) previously approved by the FDA, (2) with proven
efficacy and safety profiles, (3) with patents expiring or expired and (4)
with
proven market track records and potential.
On
June
18, 2007, Vivian H. Liu was appointed as our Chief Executive Officer. Ms. Liu
succeeded Richard J. Berman, who was elected by the Board to serve as its
non-executive Chairman. Mr. Berman was our Chief Executive Officer from January
2006 through June 2007 and has served as a Director of NexMed since
2002.
At
the
Annual Meeting of Stockholders on June 18, 2007, Ms.
Liu
was also elected to serve on the Board of Directors for a three-year term.
In
addition, we have formed a Scientific Advisory Board headed by Dr. David Tierney
who also serves as a Director on the Board of Directors. The focus of the
Scientific Advisory Board is to assist us in evaluating our current pipeline
consisting of early stage NexACT®
based
products under development, and also assist us in identifying and evaluating
new
product development opportunities going forward.
15
On
September 15, 2005, we announced an exclusive global licensing agreement with
Novartis International Pharmaceutical Ltd. (“Novartis”), for NM100060, our
proprietary nail lacquer treatment for onychomycosis (nail fungal infection).
Under the agreement, Novartis acquired the exclusive worldwide rights to
NM100060 and has assumed all further development, regulatory, manufacturing
and
commercialization responsibilities as well as costs. Novartis agreed to pay
us
up to $51 million in upfront and milestone payments on the achievement of
specific development and regulatory milestones, including an initial cash
payment of $4 million at signing. We expect to receive an additional $3 million
in early 2008 which was triggered by the recent completion of patient
recruitment in the ongoing Phase 3 trials. In addition, we are eligible to
receive royalties based upon the level of sales achieved.
On
July
9, 2007, we announced
that Novartis had completed patient enrollment for the Phase 3 clinical trials
for NM100060. The
Phase
3 program for NM100060 consists of two pivotal, randomized, double-blind,
placebo-controlled studies. The parallel group studies are designed to assess
the efficacy, safety and tolerability of NM100060 in patients with mild to
moderate toenail onychomycosis. Approximately 1,000 patients are enrolled in
the
two studies, which are taking place in the U.S., Europe, Canada and Iceland.
The
Phase 3 program is expected to be completed in mid-2008.
In
March
2007, Novartis commenced a comparator study in ten European countries. Over
900
patients with mild to moderate onychomycosis are participating in this
open-label study, which is designed to assess the safety and tolerability of
NM100060 (terbinafine 10% topical formulation) versus amorolfine 5% nail
lacquer, a topical treatment for onychomycosis that is approved in
Europe. The
comparator study is expected to be completed during the second half of 2008
and
the data will be included in the European regulatory application.
The
most
advanced of our products under development is our topical alprostadil-based
cream treatment intended for patients with erectile dysfunction (“the ED
Product”), which was previously known as Alprox-TD®.
The FDA
informed us that we could no longer use the name because of possible name
confusion with another product currently marketed. On September 21, 2007, we
filed our New Drug Application (“NDA”) with the FDA. The FDA takes up to 60 days
before confirming whether the NDA has been accepted for review.
In
December 2002, we completed our two pivotal Phase 3 studies on the ED Product
that tested over 1,700 patients with erectile dysfunction at 85 sites throughout
the U.S. We announced in 2006 that we developed a room temperature stable
prototype for the ED Product which significantly extends the shelf life of
the
product and thus makes it more attractive for potential licensing partners.
We
estimate that $5 million will have to be invested in the scale-up (developing
the prototype to production level) of the room temperature prototype. In
addition, we estimate an additional $2 million will need to be spent on our
East
Windsor manufacturing facility in order for the facility to pass inspection
by
the regulatory authorities and manufacture commercialization batches of the
refrigerated ED Product. On
November 1, 2007, we licensed the US rights of our ED Product to Warner Chilcott
Company, Inc. (“Warner”). As part of the financial package to be paid for the
right to commercialize the product, Warner will undertake the manufacturing
investment and any other investment for further product development that may
be
required for product approval.
16
We
continue to be in discussions with potential partners for Europe and other
international markets. Assuming a potential partner agrees to make the necessary
investment, the consummation of a commercialization arrangement is subject
to
complex negotiations of contractual relationships, and we may not be able to
consummate such relationship on a timely basis, or on terms acceptable to us.
Our
regulatory strategy for our ED Product includes the filing of the NDA in the
United States and New Drug Submission (“NDS”) in Canada in 2007, and Marketing
Authorization Application (“MAA”) in Europe during 2008. We have taken the
position that the safety data of the product, which is based on our clinical
database of over 3,000 patients, should be sufficient for filing the NDA/NDS/MAA
and, therefore, we do not need to conduct a 12-month open-label study as
indicated by ICH (International Conference on Harmonisation of Technical
Requirements for Registration of Pharmaceuticals for Human Use) guidance.
On
February 21, 2007, the Canadian regulatory authority, Health Canada, informed
us
that the lack of a completed 12-month open label safety study would not preclude
them from accepting and reviewing our NDS in Canada. On October 19, 2007, we
filed the NDS for our ED Product and await confirmation of acceptance for review
which typically takes up to 60 days. Once accepted, the review and approval
process takes about 12 months. Even though we are encouraged by the initial
positive feedback from Health Canada, the risk remains that we may not be
successful in convincing them to approve our product for marketing.
On
April
20, 2007, the United Kingdom regulatory authority, Medicines and Healthcare
Products Regulatory Agency (the “MHRA”) also informed us that the safety data
that we have compiled to date was sufficient for the MAA to be filed and
accepted for review in the United Kingdom. Even though we are encouraged by
the
initial positive feedback from the MHRA, the risk remains that we may not be
successful in convincing the MHRA and other European regulatory authorities
to
approve our product for marketing. Our plan is to file the MAA in Europe under
the mutual recognition system so we will submit applications in France, Germany,
Italy, Spain, and the United Kingdom which will also be identified as the
reference state for our MAA.
In
terms
of the NDA filing in the US, there has been no discussion with the FDA
concerning our regulatory position that the 3,000 patient clinical data base
should be accepted in lieu of the ICH guidance for the 12 month open-label
study. As such, we will learn whether the FDA agrees with our position when
they
review our NDA. We currently estimate the cost to complete a 12 month open-label
study to be approximately $8 million. Warner will undertake the investment
necessary to complete the 12 month open-label study should it be required by
the
FDA. There is always the risk that our NDA will not be accepted for review,
or
that even if it was accepted for review, we will not be successful in convincing
the FDA to approve the product for marketing.
17
We
are
also developing Femprox®,
which
is an alprostadil-based cream product intended for the treatment of female
sexual arousal disorder. We have completed one U.S. Phase 2 study for
Femprox®,
and
also a 400-patient study for Femprox®
in
China, where the cost for conducting clinical studies is significantly lower
than in the U.S. We have been in contact with several potential co-development
partners. We do not intend to conduct additional studies for this product until
we have secured a co-development partner.
We
have
also continued early stage development work for our product pipeline with the
goal of focusing our attention on product opportunities that would replicate
the
model of our licensed anti-fungal nail treatment.
Patents.
We
have
thirteen U.S. patents either acquired or received out of a series of patent
applications that we have filed in connection with our NexACT®
technology and our NexACT-based products under development. To further
strengthen our global patent position on our proprietary products under
development, and to expand the patent protection to other markets, we have
filed
under the Patent Cooperation Treaty corresponding international applications
for
our issued U.S. patents and pending U.S. patent applications.
The
following table identifies our thirteen U.S. patents issued for
NexACT®
technology and/or our NexACT®-based
products under development, and the year of expiration for each patent. In
addition, we have over 200 international patents and U.S. and international
patent applications pending.
Patent
Name
|
Expiration
Date
|
|||
Biodegradable
Absorption Enhancers
|
2008
|
|||
Biodegradable
Absorption Enhancers
|
2009
|
|||
Compositions
and Methods for Amelioration of Human Female Sexual
Dysfunction
|
2017
|
|||
Topical
Compositions for PGE1 Delivery
|
2017
|
|||
Topical
Compositions for Non-Steroidal Anti-Inflammatory Drug
Delivery
|
2017
|
|||
Prostaglandin
Compositions & Methods of Treatment for Male Erectile
Dysfunction
|
2017
|
|||
Medicament
Dispenser
|
2019
|
|||
Crystalline
Salts of dodecyl 2-(N, N-Dimethylamino) *
|
2019
|
|||
Topical
Compositions Containing Prostaglandin E1
|
2019
|
|||
CIP:
Topical Compositions Containing Prostaglandin E1
|
2019
|
|||
Prostaglandin
Composition and Methods of Treatment of Male Erectile
Dysfunction
|
2020
|
|||
CIP:
Prostaglandin Composition and Methods of Treatment of Male Erectile
Dysfunction
|
2020
|
|||
Topical
Stabilized Prostaglandin E Compound Dosage Forms
|
2023
|
18
*
Composition of matter patent on our NexACT®
technology which is included in all of our current products under
development
While
we
have obtained patents and have several patent applications pending, the extent
of effective patent protection in the U.S. and other countries is highly
uncertain and involves complex legal and factual questions. No consistent policy
addresses the breadth of claims allowed in or the degree of protection afforded
under patents of medical and pharmaceutical companies. Patents we currently
own
or may obtain might not be sufficiently broad to protect us against competitors
with similar technology. Any of our patents could be invalidated or
circumvented.
While
we
believe that our patents would prevail in any potential litigation, the holders
of competing patents could determine to commence a lawsuit against us and even
prevail in any such lawsuit. Litigation could result in substantial cost to
and
diversion of effort by us, which may harm our business. In addition, our efforts
to protect or defend our proprietary rights may not be successful or, even
if
successful, may result in substantial cost to us.
Research
and Development.
Governmental
authorities in the U.S. and other countries heavily regulate the testing,
manufacture, labeling, advertising, marketing and distribution of our proposed
products. None of our proprietary products under development have been approved
for marketing in the U.S. Before we market any products we develop, we must
obtain FDA and comparable foreign agency approval through an extensive clinical
study and approval process.
The
studies involved in the approval process are conducted in three phases. In
Phase
1 studies, researchers assess safety or the most common acute adverse effects
of
a drug and examine the size of doses that patients can take safely without
a
high incidence of side effects. Generally, 20 to 100 healthy volunteers or
patients are studied in the Phase 1 study for a period of several months. In
Phase 2 studies, researchers determine the drug's efficacy and short-term safety
by administering the drug to subjects who have the condition the drug is
intended to treat. At the conclusion of the study, an assessment of the correct
dosage level and whether the drug favorably affects the condition is made.
Up to
several hundred subjects may be studied in the Phase 2 study for approximately
6
to 12 months, depending on the type of product tested. In Phase 3 studies,
researchers further assess efficacy and safety of the drug. Several hundred
to
thousands of patients may be studied during the Phase 3 studies for a period
lasting from 12 months to several years. Upon completion of Phase 3 studies,
a
New Drug Application is submitted to the FDA or foreign governmental regulatory
authority for review and approval.
Our
failure to obtain requisite governmental approvals in a timely manner, or at
all, will delay or preclude us from licensing or marketing our products or
limit
the commercial use of our products, which could adversely affect our business,
financial condition and results of operations.
19
Because
we intend to sell and market our products outside the U.S., we will be subject
to foreign regulatory requirements governing the conduct of clinical trials,
product licensing, pricing and reimbursements. These requirements vary widely
from country to country. Our failure to meet a foreign country's requirements
could delay the introduction of our proposed products in such foreign country
and limit our revenues from sales of our proposed products in foreign
markets.
Successful
commercialization of our products may depend on the availability of
reimbursement to consumers from third-party healthcare payers, such as
government and private insurance plans. Even if we succeed in bringing one
or
more products to market, reimbursement to consumers may not be available or
sufficient to allow us to realize an appropriate return on our investment in
product development or to sell our products on a competitive basis. In addition,
in certain foreign markets, pricing or profitability of prescription
pharmaceuticals is subject to governmental controls. In the U.S., federal and
state agencies have proposed similar governmental control and the U.S. Congress
has recently considered legislative and regulatory reforms that may affect
companies engaged in the healthcare industry. Pricing constraints on our
products in foreign markets and possibly in the U.S. could adversely affect
our
business and limit our revenue.
Liquidity,
Capital Resources and Financial Condition.
We
have
experienced net losses and negative cash flows from operations each year since
our inception. Through September 30, 2007, we had an accumulated deficit of
$131,823,582. Our operations have principally been financed through private
placements of equity securities and debt financing. Funds raised in past periods
should not be considered an indication of our ability to raise additional funds
in any future periods.
As
a
result of our losses to date and accumulated deficit, there is doubt as to
our
ability to continue as a going concern, and, accordingly, our independent
registered public accounting firm has modified its report on our December 31,
2006 consolidated financial statements included in our Annual Report on Form
10-K in the form of an explanatory paragraph describing the events that have
given rise to this uncertainty. These factors may make it more difficult for
us
to obtain additional funding to meet our obligations. Our ability to continue
as
a going concern is based on our ability to generate or obtain sufficient cash
to
meet our obligations on a timely basis and ultimately become profitable.
At
September 30, 2007 we had cash and cash equivalents and short term investments
of approximately $2.9 million as compared to $12.1 million at December 31,
2006.
Our net decrease in cash in the first nine months of 2007 is the result of
our
average fixed monthly overhead costs of approximately $450,000 per month, direct
costs of approximately $1.9 million related to the preparation of the regulatory
filings for our ED Product including the filing fee of $896,000, and the
repayment on May 31, 2007 of the $3 million convertible notes as discussed
in
Note 5 of the unaudited consolidated financial statements. Pursuant to the
FDA
regulations, we have been notified that the filing fee of $896,000 will be
refunded to us as this is our first NDA filing and we are a small business
as
defined by the FDA regulations. As such, the filing fee is recorded in prepaid
and other current assets in the unaudited consolidated balance sheet. We expect
the filing fee to be returned to us before the end of November
2007.
20
On
October 26, 2007 we issued a note in a principal amount of $3 million (the
“2007
Note”). The 2007 Note is due June 30, 2009 and accretes interest at a rate of 8%
per annum as discussed in Note 12 of the unaudited consolidated financial
statements. We used approximately $2.1 million of the 2007 Note proceeds to
pay
in full the principal amount of the $2 million note that was due on December
31,
2007, plus accrued interest as discussed in Note 6 of the unaudited consolidated
financial statements. The approximately $900,000 remaining was added to our
current cash reserves along with the $500,000 up front payment received from
Warner as discussed in Note 12 of the unaudited consolidated financial
statements, which gives us sufficient cash reserves to fund our operations
through the end of the first quarter of 2008, based on our projected average
fixed monthly overhead costs of approximately $525,000 in 2008 and the remaining
anticipated expenditure of approximately $500,000 related to the regulatory
filings in Europe for our ED Product. Additionally, we will receive a $3 million
milestone payment from Novartis in early 2008 pursuant to the terms of the
licensing agreement whereby the payment is due seven months after the completion
of patient enrollment for
the
Phase 3 clinical trials for NM100060, which occurred in July 2007. Our cash
reserves of $3.4 million as of the date of this report together with the
expected refund of the $896,000 NDA filing fee and the $3 million milestone
payment in 2008 from Novartis should provide us with sufficient cash reserves
to
fund our operations through the end of 2008.
At
September 30, 2007 we had other receivable of $0 as compared to $183,700 at
December 31, 2006. The other receivable consists of amounts billed to Novartis
in connection with the exclusive global licensing agreement for our NM100060
nail lacquer. Pursuant to the terms of the agreement, Novartis has agreed to
reimburse us for related patent expenses as well as the remaining costs for
completion of preclinical studies that we had begun prior to the signing of
the
agreement. On February 16, 2007, the Novartis agreement was amended. Pursuant
to
the amendment, the Company is no longer obligated to complete the remaining
preclinical studies for NM100060. Novartis has taken over all responsibilities
related to the remaining preclinical studies. As
such,
we did not bill Novartis for any preclinical reimbursement costs in the first
half of 2007 and will not be billing Novartis for such costs in any future
periods.
At
September 30, 2007 we had prepaid expenses and other current assets of
$1,146,774 as compared to $164,898 at December 31, 2006. The increase is due
to
the payment of the $896,000
filing fee in connection with our filing of
the
NDA for our ED Product. As confirmed by the FDA, we expect the filing fee to
be
refunded to us before the end of November 2007 as this is our first NDA filing
and we are a small business as defined by the FDA regulations. As such, the
filing fee is recorded in prepaid and other current assets in the unaudited
consolidated balance sheet.
At
September 30, 2007 we had convertible notes of $0 as compared to $3,000,000
at
December 31, 2006. The notes were due and paid in cash on May 31, 2007.
Therefore, at September 30, 2007, there is no remaining balance due to the
holders of the convertible notes.
21
For
the
nine months ended September 30, 2007 we incurred loss on disposal of fixed
assets (included in general and administrative expenses in our unaudited
consolidated statement of operations) of $7,911 as compared to $222,798 in
2006.
The loss on disposal of fixed assets resulted from the consolidation of our
operations in 2006 into our East Windsor facility which was originally designed
for manufacturing with offices and laboratories. In consolidating our facilities
and reducing staff in 2006 we determined that we had excess laboratory
equipment. We wrote off obsolete equipment and sold many pieces of equipment.
To
date,
we have spent approximately $71 million on our ED Product development program.
Pursuant to our license agreement signed on November 1, 2007, Warner will
undertake the manufacturing investment and any other investment for further
product development that may be required for product approval in the United
States. We anticipate that the remaining cost to prepare all of the relevant
dossiers and assemble the regulatory approval applications in Canada and Europe
will be approximately $785,000 which we have budgeted in our 2007 and 2008
expenditures.
Critical
Accounting Estimates.
Our
discussion and analysis of our financial condition and results of operations
is
based upon our consolidated financial statements, which have been prepared
in
accordance with accounting principles generally accepted in the United States
of
America. The preparation of these financial statements requires our management
to make estimates and assumptions that affect the reported amounts of assets,
liabilities, revenue and expenses, and related disclosure of contingent assets
and liabilities. Our accounting policies affect our more significant judgments
and estimates used in the preparation of our financial statements. Actual
results could differ from these estimates. There have been no material changes
to our Critical Accounting Policies described in our Form 10-K filed with the
Securities and Exchange Commission on March 26, 2007.
Comparison
of Results of Operations Between the Three Months Ended September 30 of 2007
and
of 2006.
Revenue,
principally license fee revenue.
We
recorded $296,390 in revenue during the third quarter of 2007, as compared
to
$446,268 in revenue during the third quarter of 2006. The revenue consisted
of
$940 and $1,669 in 2007 and 2006, respectively, in royalties on sales of
Befar®
received
from our Asian licensee and $295,450 and $444,599, respectively, of revenue
on
our Novartis licensing agreement. The decrease in revenue in 2007 is primarily
attributable to the method used to recognize revenue from the $4 million
up-front payment received in 2005 from Novartis under the licensing agreement
for NM100060. As discussed in Note 11 to the Consolidated Financial Statements,
the Novartis agreement was amended in February 2007 such that beginning with
the
first quarter of 2007 we are recognizing the initial up-front payment and
preclinical reimbursement revenue from this agreement based on a straight-line
basis over the 18 month period ended June 30, 2008 rather than the cost-to-cost
method over the 32-month period estimated to complete the remaining preclinical
studies for NM100060. Accordingly, the Company recognized significantly more
revenue in the first quarter of 2006 as the preclinical studies were initiated
because the high costs to initiate the preclinical studies in 2005 and early
2006 resulted in a larger portion of revenue recognized under the cost-to-cost
method in 2006.
22
General
and Administrative Expenses.
Our
general and administrative expenses decreased to $1,037,421 during the third
quarter of 2007 as compared to $1,079,807 during the same period in 2006. The
modest decrease is primarily due to a recognized loss on disposal of equipment
of approximately $225,000 in 2006 as a result of the consolidation of our
operations last year. This decrease in our loss on disposal of assets was
partially offset by an increase in 2007 of $112,000 in expenses related to
the
national filings of patent applications for our ED Product as well as fees
in
connection with a patent lawsuit whereby we are the plaintiff suing for patent
infringement on our herpes treatment medical device. Additionally in the third
quarter of 2007 we had an increase in accounting fees of approximately $84,000
related to additional work performed by our independent registered accounting
firm and our internal control consultants in connection with our compliance
with
the Sarbanes-Oxley Act of 2002.
Research
and Development Expenses.
Our
research and development expenses for the third quarter of 2007 and 2006 were
$1,266,792 and $1,332,351, respectively. Research and development expenses
in
the third quarter of 2007 included approximately $521,000 attributable to our
ED
Product and the balance attributable to other NexACT®
technology based products and indirect overhead related to research and
development, as compared to approximately $295,000 for NM100060 and $372,000
for
our ED Product during
the same period in 2006. We no longer have research and development expenses
related to NM100060, as we are no longer obligated to complete the remaining
preclinical studies for NM100060. Novartis has taken over all responsibilities
related to the remaining preclinical studies whereas in 2006, we incurred the
preclinical study costs and were reimbursed by Novartis.
Interest
Expense, Net.
We had
interest expense net of interest income of $54,555 during the second quarter
of
2007, as compared to $21,945 during the same period in 2006. The increase is
primarily due to a decrease in interest income to offset the interest expense.
Interest income decreased in 2007 as a result of lower average cash balances
during the third quarter 2007 as compared to 2006 as we funded our operations
in
2007 and repaid the $3 million note due in May 2007 without any significant
cash
inflows during 2007.
Net
Loss.
The net
loss was $2,062,378 or $0.02 per share and $1,987,835 or $0.03 per share in
the
third quarter of 2007 and 2006, respectively. The increase is primarily
attributable to the decrease in revenues primarily attributable to the method
used to recognize revenue from the $4 million up-front payment received in
2005
from Novartis under the licensing agreement for NM100060. As discussed in Note
11 to the Consolidated Financial Statements, the Novartis agreement was amended
in February 2007 such that beginning with the first quarter of 2007 we are
recognizing the initial up-front payment and preclinical reimbursement revenue
from this agreement based on a straight-line basis over the 18 month period
ended June 30, 2008 rather than the cost-to-cost method over the 32-month period
estimated to complete the remaining preclinical studies for NM100060.
Accordingly, the Company recognized significantly more revenue in 2006 as the
preclinical studies were initiated because the high costs to initiate the
preclinical studies in 2005 and early 2006 resulted in a larger portion of
revenue recognized under the cost-to-cost method in 2006.
23
Comparison
of Results of Operations Between the Nine Months Ended September 30 of 2007
and
of 2006.
Revenue,
principally license fee revenues.
We
recorded $866,766 in revenue during the first nine months of 2007, as compared
to $1,433,870 in revenue during the same period in 2006. The revenue consisted
of $3,237 and $5,856 in 2007 and 2006, respectively, in royalties on sales
of
Befar®
received
from our Asian licensee and $863,529 and $1,428,014, respectively, of revenue
on
our Novartis licensing agreement. Additionally, in the second quarter of 2006,
we recognized $100,000 in research and development fee revenue received from
a
Japanese pharmaceutical company for whom we were developing a pain management
patch product. In the second quarter of 2006, we decided to terminate the
development agreement and transfer all know-how developed to date to the partner
in exchange for such fee of $100,000. The decrease in revenue in 2007 is
primarily attributable to the method used to recognize revenue from the $4
million up-front payment received in 2005 from Novartis under the licensing
agreement for NM100060. As discussed in Note 11 to the Consolidated Financial
Statements, the Novartis agreement was amended in February 2007 such that
beginning with the first quarter of 2007 we are recognizing the initial up-front
payment and preclinical reimbursement revenue from this agreement based on
a
straight-line basis over the 18 month period ended June 30, 2008 rather than
the
cost-to-cost method over the 32-month period estimated to complete the remaining
preclinical studies for NM100060. Accordingly, the Company recognized
significantly more revenue in the first half of 2006 as the preclinical studies
were initiated because the high costs to initiate the preclinical studies in
2005 and early 2006 resulted in a larger portion of revenue recognized under
the
cost-to-cost method in 2006.
General
and Administrative Expenses.
Our
general and administrative expenses decreased to $3,414,246 during the first
nine months of 2007 as compared to $3,988,395 during the same period in 2006.
The decrease is due in part to a decrease in general and administrative salaries
of approximately $109,000 as a result of our restructuring program initially
implemented in December 2005 and completed in March 2006. Additionally in the
first nine months of 2006 we recognized a loss on the disposal of equipment
of
approximately $454,000 as a result of the consolidation of our operations.
There
was also a decrease in accounting and auditing expenses of $96,000 due to the
cost savings realized during the 2006 audit of our financial statements which
occurred and is expensed in 2007. We realized additional cost saving by changing
our independent registered accounting firm for the 2006 audit. There was also
a
decrease in compensation expense of approximately $240,000 due to an increased
number of stock options issued to Richard Berman and Leonard Oppenheim who
were
appointed as Chief Executive Officer and Lead Director, respectively, in the
first half of 2006. These decreases in 2007 were partially offset by
approximately $175,000 in consulting fees for business development and market
research activities related to identifying potential commercial partners for
our
topical treatment for erectile dysfunction and $107,000 in increased expenses
related to the national filings of patent applications for our ED Product as
well as fees in connection with a patent lawsuit in which we are the plaintiff
suing for patent infringement of our herpes treatment medical device.
24
Research
and Development Expenses.
Our
research and development expenses for the first nine months of 2007 and 2006
were $3,459,390 and $3,925,827, respectively. Research and development expenses
in the first nine months of 2007 included approximately $17,500 attributable
to
NM100060, $1.4 million attributable to our ED Product and the balance
attributable to other NexACT®
technology based products and indirect overhead related to research and
development, as compared to approximately $752,000 for NM100060 and $576,000
for
our ED Product during
the same period in 2006. We no longer have research and development expenses
related to NM100060, as we are no longer obligated to complete the remaining
preclinical studies for NM100060. Novartis has taken over all responsibilities
related to the remaining preclinical studies whereas in 2006, we incurred the
preclinical study costs and were reimbursed by Novartis. Additionally, rent
and
utility expenses directly related to research and development decreased
approximately $353,000 in 2007 as a result of the completion of our
consolidation of facilities in April 2006.
Interest
Expense, Net.
We had
interest expense net of interest income of $85,838 during the first nine months
of 2007, as compared to $64,082 during the same period in 2006. The increase
is
primarily due to a decrease in interest income to offset the interest expense.
Interest income decreased in 2007 as a result of lower average cash balances
during the first nine months of 2007 as compared to 2006 as we funded our
operations in 2007 and repaid the $3 million note due in May 2007 without any
significant cash inflows during 2007.
Net
Loss.
The net
loss was $6,092,708 and $5,916,979 in the first nine months of 2007 and 2006,
respectively. The increase is attributable to a one-time payment that was
accrued by the Company in 2006 when Schering elected to terminate the supply
and
distribution agreement for our topical erectile dysfunction treatment without
cause. Pursuant to the agreement, Schering paid us a termination fee of 500,000
Euros or $627,455. We also had a decrease in revenues in 2007 as a result of
the
method used to recognize revenue from the $4 million up-front payment received
in 2005 from Novartis under the licensing agreement for NM100060. As discussed
in Note 11 to the Consolidated Financial Statements, the Novartis agreement
was
amended in February 2007 such that beginning with the first quarter of 2007
we
are recognizing the initial up-front payment and preclinical reimbursement
revenue from this agreement based on a straight-line basis over the 18 month
period ended June 30, 2008 rather than the cost-to-cost method over the 32-month
period estimated to complete the remaining preclinical studies for NM100060.
Accordingly, the Company recognized significantly more revenue in 2006 as the
preclinical studies were initiated because the high costs to initiate the
preclinical studies in 2005 and early 2006 resulted in a larger portion of
revenue recognized under the cost-to-cost method in 2006. While increased
revenue in 2006 resulted in lower net loss in 2006, the decrease in revenue
in
2007 was substantially offset by the decrease in expenses in 2007 attributable
to our restructuring program initially implemented in December 2005 and
completed in April 2006 whereby we significantly reduced our research and
development project expenditures and staff and reduced our overhead by
consolidating our facilities in 2006.
25
Net
Loss applicable to Common Stock. The
net
loss applicable to common stock was $6,092,708 or $0.07 per share for the first
nine months of 2007 as compared to $5,982,140 or $0.09 per share for 2006.
The
increase is primarily attributable to a one-time payment that was accrued by
the
Company in 2006 when Schering elected to terminate the supply and distribution
agreement for our topical treatment for erectile dysfunction without cause
and
the method used to recognize revenue from the $4 million up-front payment
received in 2005 from Novartis under the licensing agreement for NM100060 as
discussed in the previous section above. While increased revenue in 2006
resulted in lower net loss in 2006, the decrease in revenue in 2007 was
substantially offset by the decrease in expenses in 2007 attributable to our
restructuring program initially implemented in December 2005 and completed
in
April 2006 whereby we significantly reduced our research and development project
expenditures and staff and reduced our overhead by consolidating our facilities
in 2006.
ITEM
3. QUALITATIVE
AND QUANTITATIVE DISCLOSURES ABOUT MARKET RISK
There
have been no material changes to our exposures to market risk since December
31,
2006.
ITEM
4.
CONTROLS AND PROCEDURES
In
accordance with Exchange Act Rules 13a-15 and 15d-15, the Company's management
carried out an evaluation with participation of the Company's Chief Executive
Officer and Chief Financial Officer, its principal executive officer and
principal financial officer, respectively, of the effectiveness of the Company's
disclosure controls and procedures as of the end of the period covered by this
report. Based upon that evaluation, the Chief Executive Officer and Chief
Financial Officer concluded as of the end of the period covered by this Form
10-Q that the Company's disclosure controls and procedures are effective. There
were no changes in the Company's internal controls over financial reporting
that
occurred during the quarter covered by this report that have materially affected
or are reasonably likely to materially affect the Company's internal controls
over financial reporting.
PART
II. OTHER INFORMATION
ITEM
1. LEGAL
PROCEEDINGS
There
have been no material changes to the legal proceedings described in the
Company’s Form 10-K filed with the Securities and Exchange Commission on March
26, 2007.
26
ITEM
1A. RISK
FACTORS
There
have been no material changes to the risk factors described in the Company’s
Form 10-K filed with the Securities and Exchange Commission on March 26,
2007.
ITEM
2. UNREGISTERED
SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
On
August
1, 2007, the Company issued 26,518 shares of common stock to the holder of
the
$2 million Notes in payment of accrued interest for the three month period
ended
July 31, 2007 of $40,833. The common stock was issued pursuant to an exemption
provided by Section 4(2) of the Securities Act of 1933.
27
ITEM
6. EXHIBITS
31.1
|
Chief
Executive Officer’s Certificate, pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002.
|
|
31.2
|
Chief
Financial Officer’s Certificate, pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002.
|
|
32.1
|
Chief
Executive Officer’s Certificate, pursuant to 18 U.S.C. Section 1350, as
adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 –
furnished only.
|
|
32.2
|
Chief
Financial Officer’s Certificate, pursuant to 18 U.S.C. Section 1350, as
adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 –
furnished only.
|
28
SIGNATURES
In
accordance with the requirements of the Securities Exchange Act of 1934, the
registrant caused this report to be signed on its behalf by the undersigned,
thereunto duly authorized.
NEXMED,
INC.
|
|
Date:
November 14, 2007
|
/s/
Mark Westgate
|
Mark
Westgate
|
|
Vice
President and Chief Financial
|
|
Officer
|
29
EXHIBIT
INDEX
31.1
|
Chief
Executive Officer’s Certificate, pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002.
|
|
31.2
|
Chief
Financial Officer’s Certificate, pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002.
|
|
32.1
|
Chief
Executive Officer’s Certificate, pursuant to 18 U.S.C. Section 1350, as
adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 –
furnished only.
|
|
32.2
|
Chief
Financial Officer’s Certificate, pursuant to 18 U.S.C. Section 1350, as
adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 –
furnished only.
|
30