SEELOS THERAPEUTICS, INC. - Quarter Report: 2008 June (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 June 30,
2008.
|
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, a non-accelerated filer, or a smaller reporting company.
See
definitions of “large accelerated filer”, “accelerated filer” and “smaller
reporting company” in Rule 12b-2 of the Exchange Act (check one):
Large
accelerated filer o Accelerated
filer x
Non-accelerated
filer o (do
not
check if a smaller reporting company) Smaller reporting company o
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 August
4,
2008, 83,930,721 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
|
|
Unaudited
Consolidated Balance Sheets at June 30, 2008 and December 31,
2007
|
1
|
||
Unaudited
Consolidated Statements of Operations for the Three and Six Months
Ended
June 30, 2008 and June 30, 2007
|
2
|
||
Unaudited
Consolidated Statements of Cash Flows for the Six Months Ended June
30,
2008 and June 30, 2007
|
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
|
26
|
|
Item
2.
|
Unregistered
Sales of Equity Securities and Use of Proceeds
|
27
|
|
Item
4.
|
Submission
of Matters to a Vote of Security Holders
|
28
|
|
Item
6.
|
Exhibits
|
29
|
|
30
|
|||
Exhibit
Index
|
31
|
PART
I. FINANCIAL INFORMATION
ITEM
1. FINANCIAL STATEMENTS
NexMed,
Inc.
Consolidated
Balance Sheets
June
30,
|
December
31,
|
||||||
2008
|
2007
|
||||||
(Unaudited)
|
|||||||
Assets
|
|||||||
Current
assets:
|
|||||||
Cash
and cash equivalents
|
$
|
3,381,028
|
$
|
2,735,940
|
|||
Short
term investments
|
-
|
750,000
|
|||||
Debt
issuance cost, net of accumulated amortization of $22,950 and $7,565
-
current portion
|
144,980
|
68,081
|
|||||
Prepaid
expenses and other assets
|
201,380
|
127,659
|
|||||
Total
current assets
|
3,727,388
|
3,681,680
|
|||||
Fixed
assets, net
|
6,723,726
|
6,956,986
|
|||||
Debt
issuance cost, net of accumulated amortization of $0 and
$3,782
|
52,624
|
34,040
|
|||||
Total
assets
|
$
|
10,503,738
|
$
|
10,672,706
|
|||
Liabilities,
convertible preferred stock and stockholders' equity
|
|||||||
Current
liabilities:
|
|||||||
Accounts
payable and accrued expenses
|
$
|
598,799
|
$
|
621,668
|
|||
Payroll
related liabilities
|
80,064
|
693,774
|
|||||
Deferred
revenue
|
305,555
|
953,528
|
|||||
Deferred
compensation - current portion
|
62,391
|
60,929
|
|||||
Convertible
notes payable - current portion
|
1,000,000
|
-
|
|||||
Total
current liabilities
|
2,046,809
|
2,329,899
|
|||||
Long
Term liabilities:
|
|||||||
Note
payable, net of debt discount of $461,295
|
-
|
2,538,705
|
|||||
Convertible
notes payable
|
4,750,000
|
-
|
|||||
Deferred
compensation
|
967,816
|
999,345
|
|||||
Total
Liabilities
|
7,764,625
|
5,867,949
|
|||||
Commitments
and contingencies (Note 10)
|
|||||||
Stockholders'
equity:
|
|||||||
Common
stock, $.001 par value, 120,000,000 shares authorized, 83,910,721
and
83,063,002 and outstanding, respectively
|
83,912
|
83,065
|
|||||
Additional
paid-in capital
|
140,444,213
|
139,239,794
|
|||||
Accumulated
deficit
|
(137,789,012
|
)
|
(134,518,102
|
)
|
|||
Total
stockholders' equity
|
2,739,113
|
4,804,757
|
|||||
Total
liabilities and stockholder's equity
|
$
|
10,503,738
|
$
|
10,672,706
|
See
notes
to unaudited consolidated financial statements.
1
NexMed,
Inc.
Consolidated
Statements of Operations
FOR THE THREE MONTHS
ENDED JUNE 30,
|
FOR THE SIX MONTHS
ENDED JUNE 30,
|
||||||||||||
2008
|
2007
|
2008
|
2007
|
||||||||||
Revenues,
principally license fee revenue
|
$
|
1,199,612
|
$
|
283,417
|
$
|
2,151,399
|
$
|
570,376
|
|||||
Operating
expenses
|
|||||||||||||
Research
and development
|
1,096,402
|
1,114,715
|
2,265,493
|
2,192,598
|
|||||||||
General
and administrative
|
1,193,379
|
1,143,930
|
2,496,777
|
2,376,825
|
|||||||||
Total
operating expenses
|
2,289,781
|
2,258,645
|
4,762,270
|
4,569,423
|
|||||||||
Loss
from operations
|
(1,090,169
|
)
|
(1,975,228
|
)
|
(2,610,871
|
)
|
(3,999,047
|
)
|
|||||
Interest
expense, net
|
(538,554
|
)
|
(15,793
|
)
|
(660,039
|
)
|
(31,283
|
)
|
|||||
Net
loss
|
(1,628,723
|
)
|
(1,991,021
|
)
|
(3,270,910
|
)
|
(4,030,330
|
)
|
|||||
Basic
and diluted loss per common share
|
$
|
(0.02
|
)
|
$
|
(0.02
|
)
|
$
|
(0.04
|
)
|
$
|
(0.05
|
)
|
|
Weighted
average common shares outstanding used for basic and diluted loss
per
share
|
83,508,503
|
81,606,401
|
83,301,425
|
81,206,974
|
See
notes
to unaudited consolidated financial statements.
2
NexMed,
Inc.
Consolidated
Statements of Cash Flows (Unaudited)
FOR THE SIX MONTHS ENDED
JUNE
30,
|
|||||||
2008
|
2007
|
||||||
Cash
flows from operating activities
|
|||||||
Net
loss
|
$
|
(3,270,910
|
)
|
$
|
(4,030,330
|
)
|
|
Adjustments
to reconcile net loss to net cash used in operating
activities
|
|||||||
Depreciation
and amortization
|
248,393
|
341,632
|
|||||
Non-cash
interest, amortization of debt discount and deferred financing
costs
|
586,366
|
225,335
|
|||||
Non-cash
compensation expense
|
630,771
|
568,408
|
|||||
Loss
on disposal of fixed assets
|
2,605
|
-
|
|||||
Decrease
in other receivable
|
183,700
|
||||||
Increase
in prepaid expenses and other assets
|
(73,721
|
)
|
(118,102
|
)
|
|||
Decrease
in accounts payable and accrued expenses
|
(22,869
|
)
|
(74,392
|
)
|
|||
Decrease
in payroll related liabilities
|
(613,710
|
)
|
(92,638
|
)
|
|||
Decrease
in deferred compensation
|
(30,067
|
)
|
(40,698
|
)
|
|||
Decrease
in deferred revenue
|
(647,973
|
)
|
(564,639
|
)
|
|||
Net
cash used in operating activities
|
(3,191,115
|
)
|
(3,601,724
|
)
|
|||
Cash
flows from investing activities
|
|||||||
Capital
expenditures
|
(17,742
|
)
|
(49,188
|
)
|
|||
Purchase
of marketable securities and short term investments
|
-
|
(3,000,000
|
)
|
||||
Proceeds
from sale of marketable securities and short term
investments
|
750,000
|
1,500,000
|
|||||
Net
cash provided by (used in) investing activities
|
732,258
|
(1,549,188
|
)
|
||||
Cash
flows from financing activities
|
|||||||
Issuance
of common stock, net of offering costs of $2,110
|
-
|
(2,110
|
)
|
||||
Proceeds
from exercise of stock options and warrants
|
459,749
|
164,192
|
|||||
Repayment
of note payable
|
(3,000,000
|
)
|
-
|
||||
Issuance
of convertible notes, net of debt issuance costs of
$105,804
|
5,644,196
|
-
|
|||||
Repayment
of convertible notes payable
|
-
|
(3,000,000
|
)
|
||||
Net
cash provided by (used in) financing activities
|
3,103,945
|
(2,837,918
|
)
|
||||
Net
increase (decrease) in cash and cash equivalents
|
645,088
|
(7,988,830
|
)
|
||||
Cash
and cash equivalents, beginning of period
|
$
|
2,735,940
|
$
|
11,069,133
|
|||
Cash
and cash equivalents, end of period
|
$
|
3,381,028
|
$
|
3,080,303
|
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 six months ended June 30, 2008 are not necessarily indicative of the
results that may be expected for the year ending December 31, 2008. These
financial statements should be read in conjunction with the financial statements
and notes thereto contained in NexMed, Inc.’s (the “Company” or “NexMed”) Annual
Report on Form 10-K for the year ended December 31, 2007.
The
Company had an accumulated deficit of $137,789,012 at June 30, 2008 and the
Company expects to incur additional losses during the remainder of 2008. 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,
2007 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 anticipates that the Company may
require additional financing to fund operations, including continued research,
development and clinical trials of the Company’s product candidates. Before the
end of 2008, the Company expects significant cash infusions from Novartis
International Pharmaceutical Ltd. (“Novartis”) assuming the Phase 3 trial for
NM100060, our nail fungus treatment, is successful. However, there is no
certainty that the Phase 3 trial will be successful. Should the Phase 3 trial
be
unsuccessful then the Company will not receive any of the remaining milestone
payments from Novartis and management will have to pursue such funding. 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
May
2008, the FASB issued Staff Position No. APB 14-1 “Accounting for Convertible
Debt Instruments That May Be Settled in Cash Upon Conversion (Including Partial
Cash Settlement)” (“FSP APB14-1”), which clarifies the accounting for
convertible debt instruments that may be settled in cash (including partial
cash
settlement) upon conversion. FSP APB 14-1 requires issuers to account separately
for the liablility and equity components of certain convertible debt instruments
in a manner that reflects the issuer’s non-convertible debt borrowing rate when
interest cost is recognized. FSP APB 14-1 requires retrospective application
to
the terms of the instruments as they existed for all periods presented. FSB
APB
14-1 is effective for the Company as of January 1, 2009 and early adoption
is
prohibited. The Company is currently evaluating the impact of adopting FSB
APB
14-1 on its consolidated financial statements as a result of its convertible
debt, as discussed in Note 5 below.
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 and an additional 2,000,000 shares
were added to the plan in June 2008. 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.
The
Company follows 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 modified
prospective transition method as prescribed by SFAS 123R. Under this transition
method, stock-based compensation expense for the three and six months ended
June
30, 2008 and June 30, 2007 includes expense for all equity awards granted during
the three and six months ended June 30, 2008 and June 30, 2007 and prior, but
not yet vested as of January 1, 2006 (the adoption date of SFAS 123R), 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.” The following table indicates where the
total stock-based compensation expense resulting from stock options and awards
appears in the Statement of Operations (unaudited):
5
FOR THE THREE MONTHS
ENDED JUNE 30,
|
FOR THE SIX MONTHS
ENDED JUNE 30,
|
||||||||||||
2008
|
2007
|
2008
|
2007
|
||||||||||
Research
and development
|
9,595
|
6,087
|
18,778
|
31,053
|
|||||||||
General
and administrative
|
$
|
291,206
|
$
|
204,008
|
$
|
583,893
|
$
|
477,355
|
|||||
Stock-based
compensation expense
|
$
|
300,801
|
$
|
210,095
|
$
|
602,671
|
$
|
508,408
|
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.
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 six month periods ended June 30, 2008 and June 30, 2007:
Dividend
yield
|
0.00
|
%
|
||
Risk-free
yields
|
1.35% - 5.02
|
%
|
||
Expected
volatility
|
54.38%
- 103.51
|
%
|
||
Expected
option life
|
1
- 6 years
|
|||
Forfeiture
rate
|
6.41
|
%
|
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 June 30, 2008,
and related transactions for the six month period then ended (unaudited):
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
|
2,878,090
|
7.27
years
|
$
|
0.87
|
$
|
1,310,820
|
2,571,687
|
$
|
0.83
|
$
|
1,263,018
|
|||||||||||
2.00
- 3.99
|
139,250
|
2.59
years
|
2.83
|
-
|
139,250
|
2.83
|
-
|
|||||||||||||||
4.00
- 5.50
|
373,651
|
4.01
years
|
4.65
|
-
|
373,651
|
4.65
|
-
|
|||||||||||||||
7.00
- 12.00
|
18,000
|
1.93
years
|
8.67
|
-
|
18,000
|
8.67
|
-
|
|||||||||||||||
3,408,991
|
6.69
years
|
$
|
1.40
|
$
|
1,310,820
|
3,102,588
|
$
|
1.42
|
$
|
1,263,018
|
7
Weighted
|
Weighted
|
Total
|
|||||||||||
Average
|
Average Remaining
|
Aggregate
|
|||||||||||
Number
of
|
Exercise
|
Contractual
|
Intrinsic
|
||||||||||
Shares
|
Price
|
Term
|
Value
|
||||||||||
Outstanding
at December 31, 2007
|
3,469,841
|
||||||||||||
Granted
|
-
|
$
|
-
|
||||||||||
Exercised
|
(55,000
|
)
|
$
|
0.73
|
|||||||||
Forfeited
|
(5,850
|
)
|
$
|
11.78
|
|||||||||
Outstanding
at June 30, 2008
|
3,408,991
|
$
|
1.40
|
6.69
years
|
$
|
1,310,820
|
|||||||
Vested
or expected to vest at June 30, 2008
|
3,190,475
|
$
|
1.40
|
6.69
years
|
$
|
1,226,796
|
|||||||
Exercisable
at June 30, 2008
|
3,102,588
|
$
|
1.42
|
6.50
years
|
$
|
1,263,018
|
No
options were granted during the six months ended June 30, 2008. 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 six months ended June 30, 2008 and 2007 was $43,270 and
$8,529, respectively. Cash received from option exercises for the six months
ended June 30, 2008 and June 30, 2007, was $39,750 and $15,664,
respectively.
On
January 9, 2008 the Company issued awards of shares of the Company’s common
stock to each independent Director as compensation for their services during
the
year ending December 31, 2008. In lieu of cash compensation, the independent
Directors have opted to receive, and the Board of Directors has approved, a
full
grant of 24,324 shares of the Company's common stock to each independent
Director for his services to be rendered to the Board of Directors during the
2008 calendar year. The price per share (the "Price") is the average of the
closing price of the Company's common stock over five consecutive trading days,
commencing on January 2, 2008. The number of the full grant of shares was
calculated based on the amount of cash the Director would have received for
annual service on the Board, or $36,000, divided by the Price.
Of
the
24,324 shares being granted to each independent Director, 2,027 of such shares
will vest each month during calendar 2008. As such, for the six months ended
June 30, 2008, 12,162 shares vested and were issued to each independent
Director.
3. WARRANTS
A
summary
of warrant activity for the six month period ended June 30, 2008 is as
follows:
Common Shares
|
Average
|
Average
|
||||||||
Issuable upon
|
Exercise
|
Contractual
|
||||||||
Exercise
|
Price
|
Life
|
||||||||
Outstanding
at December 31, 2007
|
12,439,954
|
$
|
1.23
|
2.43 years
|
||||||
Issued
|
250,000
|
$
|
1.15
|
|||||||
Exercised
|
(471,910
|
)
|
$
|
0.89
|
||||||
Cancelled
|
(100,000
|
)
|
$
|
1.52
|
||||||
Outstanding
at June 30, 2008
|
12,118,044
|
$
|
1.23
|
1.94 years
|
||||||
Exercisable
at June 30, 2008
|
12,118,044
|
$
|
1.23
|
1.94 years
|
8
Cash
received from warrant exercises for the six months ended June 30, 2008 and
June
30, 2007, was $420,000 and $148,528, respectively. On April 25, 2008, the
Company adjusted the warrant price for holders of warrants dated January 23,
2006 who wished to exercise their warrants and purchase shares of the Company’s
common stock for cash only. The warrant price was adjusted from $1.11 to $0.89
for the three day period ended April 29, 2008. The Company received proceeds
of
$420,000 upon the issuance of 471,910 shares of the Company’s common stock upon
the exercise of such warrants.
Additionally,
2,663,400 warrants were exercised during the six months ended June 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
June
30, 2008 and 2007, respectively, options to acquire 3,408,991 and 3,409,841
shares of common stock with exercise prices ranging from $0.55 to $16.25 per
share and warrants to acquire 12,118,044 and 13,010,786 shares of common stock
with exercise prices ranging from $0.55 to $3.00 and convertible securities
convertible into 2,946,429 and zero shares of common stock at a weighted average
conversion price of $1.95 were excluded from the calculation of diluted loss
per
share, as their effect would be anti-dilutive. Loss per share for the three
months and six ended June 30, 2008 and 2007 was calculated as follows (net
loss
/ weighted average common shares outstanding):
FOR
THE THREE MONTHS
ENDED
JUNE 30,
|
FOR
THE SIX MONTHS
ENDED
JUNE 30,
|
||||||||||||
2008
|
2007
|
2008
|
2007
|
||||||||||
Net
loss
|
$ |
(1,628,723
|
)
|
$ |
(1,991,021
|
)
|
$ |
(3,270,910
|
)
|
$ |
(4,030,330
|
)
|
|
Weighted
average common shares outstanding used for basic and diluted loss
per
share
|
83,508,503
|
81,606,401
|
83,301,425
|
81,206,974
|
|||||||||
Basic
and diluted loss per common share
|
$
|
(0.02
|
)
|
$
|
(0.02
|
)
|
$
|
(0.04
|
)
|
$
|
(0.05
|
)
|
5. CONVERTIBLE
NOTES PAYABLE
On
June
30, 2008, the Company issued convertible notes (the “Notes”) in an aggregate
principal amount of $5.75 million. The
Notes
are due on December 31, 2011 (the “Due Date”) and
are
collateralized by the Company’s facility in East Windsor, New Jersey.
The
Notes are convertible into shares of the Company’s common stock (the “Common
Stock”), par value $0.001 per share, with $4.75 million convertible at $2
per share
on
or before the Due Date and $1 million convertible at $1.75 per share on or
before December 31, 2008. The Notes have a coupon rate of 7% per annum, which
is
payable at the Company’s option in cash or, if the Company’s net cash balance is
less than $3 million at the time of payment, in shares of Common Stock. If
paid
in shares of Common Stock, then the price will be calculated at the lesser
of
$0.08 below or 95% of a five-day weighted average of the market price of the
Common Stock prior to the time of payment. Such additional interest
consideration is considered contingent and therefore would only be recognized
upon occurrence.
9
6. NOTES
PAYABLE
October
2007 Note
On
October 26, 2007 the Company issued a note in a principal amount of $3 million.
The note was payable on June 30, 2009 and could be prepaid by the Company at
any
time without penalty. Interest accreted on the note on a quarterly basis at
a
rate of 8.0% per annum. The note was collateralized by the Company’s facility in
East Windsor, New Jersey.
The
Company also issued to the noteholder 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 vested immediately and the remaining 100,000
warrants would have vested if the note had remained outstanding on October
26,
2008. The Company valued the warrants using the Black-Scholes pricing model.
The
Company allocated a relative fair value of $512,550 to the warrants. The
relative fair value of the warrants is allocated to additional paid-in capital
and treated as a discount to the note that was being amortized over the 20-month
period ending June 30, 2009.
This
note
was paid on June 30, 2008 with the proceeds from the issuance of the $5.75
million convertible notes referred to above in Note 5. The Company paid in
cash
the $3 million balance on the Note plus accrued interest of $60,000.
Additionally, the remaining 100,000 warrants that were to vest on October 26,
2008 were cancelled.
For
the
six months ended June 30, 2008, the Company recorded $461,291 of amortization
related to the note discount.
November
2006 Note
On
November 30, 2006, the Company issued a note in the principal amount of $2
million that was paid off on October 29, 2007. 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, New Jersey. 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%.
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.
10
The
Company also issued the noteholder 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 through the October 2007 repayment
date.
This
note
was paid on October 29, 2007 with the proceeds from the issuance of the October
2007 note referred to above. The Company paid in cash the $2 million balance
on
the Note plus accrued interest of $42,028.
For
the
six months ended June 30, 2007, the Company recorded $63,692 of amortization
related to the note discount.
7.
LINE
OF
CREDIT
On
May
12, 2008 the Company entered into a Binding Commitment for a Credit Line (the
“Commitment”), with one of its largest shareholders (the “Lender”). Pursuant to
the Commitment, the Company established a $3 million credit line (the “Credit
Line”) with the Lender, which expires on December 31, 2008. The Company may draw
down (“Draw Down”) on the Credit Line up to five times during the term of the
Credit Line, and Draw Downs may not exceed $600,000 in any 30 day period. In
addition, the Company may only Draw Down when the Company’s cash and cash
equivalents are below $1 million, and the Company must give the Lender at least
5 days’ notice prior to any Draw Down. In the event the results from the Phase 3
trials on the Company’s anti-fungal product are negative, further Draw Downs on
the Credit Line will be prohibited.
The
Company may repay the Draw Downs in either shares of the Company’s common stock
(the “Common Stock”), par value $0.001 per share, or cash at the Lender’s option
on December 31, 2008. If the Lender chooses to be repaid with Common Stock,
the
number of shares of Common Stock issued will be equal to the amount of the
total
Draw Down divided by $1.01, which is 92.5% of the 5 day volume weighted average
price of the Company’s Common Stock for the 5 day period ended May 9, 2008.
In
consideration of making available the Credit Line, the Lender received a warrant
(the “Warrant”) to purchase 250,000 shares of the Company’s Common Stock, which
vested immediately upon the execution of the Commitment. The Warrant has a
3
year term at an exercise price of $1.15, which is 105% of the 5 day volume
weighted average price of the Company’s Common Stock for the 5 day period ended
May 9, 2008. The Company valued the Warrant using the Black-Scholes pricing
model. The Company allocated a relative fair value of $114,750 to the Warrant.
The relative fair value of the Warrant is allocated to additional paid-in
capital and treated as a debt issuance cost that is being amortized over the
7.5-month period ending December 31, 2008.
11
For
the
six months ended June 30, 2008, the Company recorded $22,950 of amortization
related to the debt issuance cost of the Credit Line. As of June 30, 2008 there
have been no Draw Downs under the commitment.
8.
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 is $9,158. As of June 30, 2008, the Company has
accrued $1,030,207 in deferred compensation.
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.
In
June
2006, the FASB issued FASB Interpretation No. ("FIN") 48 "Accounting for
Uncertainty in Income Taxes" ("FIN 48"). 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 2004-2007 remain open to
examination by the major taxing jurisdictions to which we are
subject.
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 (“Vitaros®”)
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
June
30, 2008, such amount is approximately $1.1 million.
12
11. LICENSING
AGREEMENTS
On
November 1, 2007, the Company signed an exclusive licensing agreement with
Warner Chilcott Company, Inc. (“Warner”) for Vitaros®.
Under
the agreement, Warner acquired the exclusive rights in the United States to
Vitaros®
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 in the future based upon the level of sales
achieved by Warner, assuming the FDA approves the product.
The
Company is recognizing the initial up-front payment as revenue on a
straight-line basis over the estimated 9-month period ending July 31, 2008
which
is the remaining anticipated review time by the FDA for the Company’s new drug
application filed in September 2007 for Vitaros®
.
Pursuant to the agreement, NexMed is responsible for the regulatory approval
of
Vitaros®
.
Accordingly, for the six months ended June 30, 2008, the Company recognized
licensing revenue of $333,334 related to the Warner agreement.
On
September 15, 2005, the Company signed an exclusive global licensing agreement
with Novartis for its topical nail solution for the treatment of onychomycosis
(nail fungal infection), NM100060. Under the agreement, Novartis acquired the
exclusive worldwide rights to NM100060 and assumed all further development,
regulatory, manufacturing and commercialization responsibilities as well as
costs. Novartis agreed to pay the Company up to $51 million in up-front 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 of up to $3.25 million. The Company began 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 was 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
six months ended June 30, 2008, the Company recognized licensing revenue of
$564,639 related to the initial cash payment at signing.
On
March
4, 2008, the Company received a $1.5 million milestone payment from Novartis
pursuant to the terms of the licensing agreement whereby the payment was due
seven months after the completion of patient enrollment for
the
Phase 3 clinical trials for NM100060, which occurred in July 2007. Although
the
completion of patient enrollment in the ongoing Phase 3 clinical trials for
NM100060 triggers a $3 million milestone payment from Novartis, the agreement
also provides that clinical milestones paid to us by Novartis shall be reduced
by 50% until we receive an approved patent claim on the NM100060 patent
application filed with the U.S. patent office in November 2004. The $1.5 million
milestone payment is being recognized on a straight-line basis over the
estimated remaining six months to complete the Phase 3 clinical trial.
Accordingly, for the six months ended June 30, 2008, the Company recognized
licensing revenue of $1,250,000 related to the $1.5 million milestone
payment.
13
On
June
27, 2008, the Company executed a Side Letter regarding early payment of the
Phase III Milestone Payment according to the agreement with Novartis. Pursuant
to the Side Letter, the parties agreed that the Phase III Completion Milestone
payment of $6 million would be based on Novartis’ review and approval of the
first interpretable results of the final study report rather than the completion
of the final study report. In exchange, the Company will continue to fulfill
its
obligations pursuant to the agreement and (a) transfer the IND for NM100060
to
Novartis within thirty (30) days of the date of the Side Letter; and (b) provide
full and timely support for Novartis’ preparation of the NDA for NM100060. The
IND was transferred to Novartis on July 24, 2008.
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 as well as in conjunction with the Risk Factors section of our Form
10-K for the year ended December 31, 2007 filed with the Securities and Exchange
Commission on March 12, 2008. 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 male and female sexual dysfunction, nail
fungus, psoriasis, 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 interim 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. On November
2,
2007, we announced the appointment of Mr. Hemanshu Pandya to the position of
Vice President and Chief Operating Officer. 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
We
have
an exclusive global licensing agreement with Novartis International
Pharmaceutical Ltd. (“Novartis”) for NM100060, our proprietary topical nail
solution for the treatment of 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. In addition, we are eligible to receive royalties based upon the level
of sales achieved.
The
completion of patient enrollment in the Phase 3 clinical trials for NM100060
triggered a $3 million milestone payment from Novartis. Pursuant to the terms
of
the licensing agreement with Novartis, this payment was due on February 4,
2008,
or 7 months after last patient enrolled in the Phase 3 studies. However, the
agreement also provides that clinical milestones paid to us by Novartis shall
be
reduced by 50% until we receive an approved patent claim on the NM100060 patent
application which we filed with the U.S. patent office in November 2004. As
such, we received $1.5 million from Novartis on March 4, 2008. Based on the
office actions received to date, we expect to receive an approved patent claim
before the end of August 2008. When we file the patent issuance fee, it would
trigger an additional $2 million patent milestone due from Novartis, and cause
Novartis to release the balance of $1.5 million remaining from the $3 million
patient enrollment milestone. However, there is no certainty that we will
receive an approved patent claim for NM100060 this year or at all.
In
July
2008, Novartis
completed testing for the Phase 3 clinical trials for NM100060. The
Phase
3 program required for the filing of the New Drug Application (“NDA”) in the
U.S. for NM100060 consists of two pivotal, randomized, double-blind,
placebo-controlled studies. The parallel group studies were designed to assess
the efficacy, safety and tolerability of NM100060 in patients with mild to
moderate toenail onychomycosis. Approximately 1,000 patients completed testing
in the two studies, which took place in the U.S., Europe, Canada and Iceland.
The
Phase
3 program top line results are expected to be available to us in September
2008,
with Novartis planning to file the NDA in the U.S. before the end of 2008 if
the
Phase 3 trial data is successful. If the trial is successful, we will receive
significant cash infusions from Novartis before year-end. Per the agreement,
we
will receive a $6 million clinical milestone payment for positive Phase 3
results and a $7 million and $3 million milestone payment for the filing of
the
NDA in the U.S. and the Marketing Authorization Application (“MAA”) in Europe,
respectively. However, there is no certainty that the Phase 3 trial will be
successful. Should the Phase 3 trial be unsuccessful then we will not receive
any of the $16 million stated above and the licensing agreement with Novartis
will most likely be terminated.
16
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 Loceryl®
(amorolfine) 5% nail lacquer, a topical treatment for onychomycosis that is
approved in Europe. The comparator study is expected to be completed by early
2009 and the data will be included in the MAA, which is currently scheduled
to
be filed after the U.S. filing for approval.
The
most
advanced of our products under development is our topical alprostadil-based
cream treatment intended for patients with erectile dysfunction (“Vitaros®
”),
which
was previously known as Alprox-TD®.
Our NDA
was filed and accepted for review by the FDA in September and November 2007,
respectively. During
a
teleconference with the FDA in early July 2008, our use of the name Vitaros® for
the ED Product was verbally approved by the FDA. On July 21, 2008, we received
a
not approvable letter from the FDA in response to our NDA. The major regulatory
issues raised by the FDA were related to the results of the transgenic mouse
carcinogenicity study which NexMed completed in 2002. The transgenic mouse
concern raised by the FDA is product specific, and does not affect the
dermatological products in our pipeline, specifically NM100060. We plan to
meet
with the FDA by early October 2008 and come to agreement on the necessary
actions required in order to resubmit our NDA and resolve the deficiencies
cited
for our NDA for Vitaros®. We will also submit to the FDA final reports for two
new, two-year carcinogenicity studies in both mice and rats, which were
identified in the FDA’s letter as part of the information package needed to
resolve the major deficiencies cited. We expect to have the final reports ready
for submission to the FDA in September 2008.
On
November 1, 2007, we licensed the U.S. rights of Vitaros®
to
Warner
Chilcott Company, Inc. (“Warner”). Warner paid us $500,000 upon signing and
agreed to pay us up to $12.5 million on the achievement of specific regulatory
milestones and will undertake the manufacturing investment and any other
investment for further product development that may be required for product
approval, including an estimated $2 million for improvements to our East Windsor
manufacturing facility in order for the facility to be ready for commercial
manufacturing. Additionally, Warner is responsible for the commercialization
of
Vitaros®.
However, should Warner determine that it does not wish to continue the
regulatory approval process for Vitaros®,
the
licensing agreement would terminate, and the U.S. rights to Vitaros®
would
revert back to us. In
the
meantime, we are actively working with Warner in the preparation of our response
to the FDA concerning its letter dated July 21, 2008.
The
NDA
for Vitaros®
is
based
on a formulation that requires refrigeration for stability. We have developed
the prototype for a non-refrigerated Vitaros®.
We
estimate that $5 million will have to be invested in the scale-up (developing
the prototype to production level) of the room temperature version of
Vitaros®.
Pursuant to the Warner contract, Warner would fund the development expenses
for
the room temperature Vitaros®
if
Warner and NexMed jointly decide to switch to the room temperature Vitaros®
for
commercialization.
17
In
terms
of the NDA filing in the U.S., we have taken the regulatory position that the
long term safety data for Vitaros® should
be
based on our clinical database of over 3,000 patients, instead of 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. We did not obtain the FDA’s opinion of our regulatory position prior
to our filing the NDA for Vitaros®.
In
its
July 21, 2008 letter to us, the FDA did not cite the lack of completion of
our
long term open label safety study as a deficiency, which would have taken up
to
18 months to complete and at a cost of $8 million.
In
January 2008, the FDA began and completed the pre-approval inspection (“PAI”) of
our facility, which is a requirement upon the filing of the NDA for Vitaros®.
The PAI
is conducted by the FDA to ensure that our facility is in compliance with Good
Manufacturing Practices (“GMP”) as defined by FDA regulations and to determine
if we have the ability to begin commercial manufacturing upon approval of the
NDA. The PAI was completed with certain observations made by the FDA and a
withhold status was placed on the facility, which means that the facility is
currently not approved by the FDA for commercial manufacturing. In
its
July 21, 2008 letter to us, the FDA indicated that satisfactory resolution
of
these deficiencies is required before our NDA can be approved.
We
expect to complete our response to their observations before the end of August
2008 in order to ensure that our facility is compliant with GMP well in advance
of commercial manufacturing. While Warner intends to manufacture Vitaros®
in the
future, our facility is listed as the manufacturing and quality control
laboratory in the NDA and will likely be the initial site for commercial
manufacturing of Vitaros®
upon its
approval for commercialization.
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 New Drug Submission (“NDS”) in Canada
which was accepted for review on February 15, 2008. On May 2, 2008, we announced
that our manufacturing facility received a GMP compliance certification from
Health Canada, which is essential for the ultimate approval and marketing of
Vitaros®
in
Canada. The review and approval process in Canada typically takes about 12
to 18
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. We had another guidance meeting
with
the MHRA in January 2008 and received additional input for the preparation
of
our MAA. However, the MHRA informed us at that time that due to the backlog
of
MAA filings, they would not be able to receive and start reviewing our MAA
until
February 2009. 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.
18
We
are
also developing Femprox®,
which
is an alprostadil-based cream product intended for the treatment of female
sexual arousal disorder. We have completed nine clinical studies to date,
including one 98-patient Phase 2 study in the U.S. 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 do not intend to conduct additional studies for this product
until we have secured a co-development partner, which we are actively
seeking.
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. Our current efforts are
focused on the development of viable topical treatments for psoriasis, a common
dermatological condition.
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
|
*
Composition of matter patent on our NexACT®
technology which is included in all of our current products under clinical
development
19
The
two
patents covering the first generation of the NexACT®
technology enhancer will expire in 2008 and 2009. However, our current products
under clinical development contain the second generation of the
NexACT®
technology which is protected by a patent that will expire in 2019.
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,
an
NDA may be 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.
20
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.
We
have
experienced net losses and negative cash flows from operations each year since
our inception. Through June 30, 2008, we had an accumulated deficit of
$137,789,012. 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,
2007 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
June
30, 2008 we had cash and cash equivalents and short term investments of
approximately $3.4 million as compared to $3.5 million at December 31, 2007.
Our
cash used in operations in the first half of 2008 is due to our average fixed
monthly overhead costs of approximately $525,000 per month, in addition to
approximately $600,000 for 2007 bonuses which were paid to employees in March
2008. Additionally, we spent approximately $450,000 to support our NDA and
NDS
filings for Vitaros®.
This
cash usage in 2008 was mostly offset by the receipt of a $1.5 million milestone
payment from Novartis on March 4, 2008 for the completion of patient enrollment
in the Phase 3 trials of NM100060, as discussed in Note 11 of the Consolidated
Financial Statements and the net proceeds of approximately $2.6 million received
upon the issuance of the Convertible Notes as discussed in Note 5 of the
Consolidated Financial Statements.
21
Our
cash
reserves of $2.8 million as of the date of this report provide us with
sufficient cash to fund our operations through the end of 2008 based on our
projected 2008 monthly overhead costs
of
approximately $525,000. We will receive a total of $3.5 million from Novartis
when we receive the approved claim on the NM100060 patent application. The
$3.5
million anticipated payment is comprised of the balance of $1.5 million due
from
the patient enrollment milestone as well as a $2 million patent milestone.
Based
on our most recent discussions with the U.S. Patent Office, we expect our patent
to be allowed before the end of August 2008, thereby providing sufficient cash
reserves to fund our operations through the first half of 2009.
However,
there is no certainty that we will receive an approved patent claim for NM100060
this year or at all. Should we not receive an approved patent claim, it may
be
necessary to obtain additional funding to continue our operations into 2009.
We
will
continue to spend modestly on our early stage projects under development and
do
not
intend to trigger the approximately $800,000 in direct expenditures budgeted
for
such projects until we have significantly improved our cash
position.
Before
the end of 2008, we also expect significant cash infusions from Novartis
assuming the Phase 3 trials for NM100060 is successful. We will receive a $6
million clinical milestone payment from Novartis if the results from the Phase
3
trials are positive and a $7 million and $3 million milestone payment upon
the
filings of the NDA in the U.S. and MAA in Europe, respectively. However, there
is no certainty that the Phase 3 trial will be successful. Should the Phase
3
trial be unsuccessful then we will not receive any of the $16 million stated
above and the licensing agreement with Novartis will most likely be terminated.
At
June
30, 2008 we had prepaid expenses and other current assets of $201,380 as
compared to $127,659 at December 31, 2007. The increase is due to the renewal
of
our insurance policies in May 2008 for the policy period ending in May 2009.
The
premiums are paid in advance, recorded as prepaid expenses on the consolidated
balance sheet, and then amortized and expensed on a straight line basis over
the
12 month period ending May 2009.
At
June
30, 2008, we had $80,064 in payroll related liabilities as compared to $693,774
at December 31, 2007. The decrease is attributable to the payment of 2007
bonuses in March 2008. Our bonuses were accrued and expensed in 2007 but were
not paid until the first quarter of 2008.
At
June
30, 2008 we had convertible notes of $5,750,000. As discussed in Note 5 of
the
Consolidated Financial Statements we issued $5,750,000 of the Convertible Notes
on June 30, 2008.
At
December 31, 2007 had a note payable of $2,538,705. The note was paid in cash
on
June 30, 2008 with the proceeds received from the Convertible Notes discussed
above. Therefore, at June 30, 2008, there is no remaining balance due to the
holder of the note.
22
To
date,
we have spent approximately $71.5 million on our Vitaros® 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 Europe will be
approximately $500,000. We do not intend to trigger those expenses until we
significantly improve our cash reserves or engage a partner in Europe to
undertake these expenses.
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 12, 2008.
Comparison
of Results of Operations Between the Three Months Ended June 30, 2008 and
2007.
Revenue,
principally license fee revenue.
We
recorded $1,199,612 in revenue during the second quarter of 2008, as compared
to
$283,417 in revenue during the second quarter of 2007. The increase in revenue
is primarily due to the $750,000 in revenue recognized related to the $1.5
million milestone payment received from Novartis on March 4, 2008 as discussed
in Note 11 of the Consolidated Financial Statements. Additionally, the increase
in revenue in 2008 is the result of the $166,667 in revenue recognized in 2008
attributable to the up-front payment received in November 2007 from Warner
as
discussed in Note 11 of the Consolidated Financial Statements.
Research
and Development Expenses.
Our
research and development expenses for the second quarter of 2008 and 2007 were
$1,096,402 and $1,114,715, respectively. Research and development expenses
in
the second quarter of 2008 included approximately $264,000 attributable to
Vitaros® and
the
balance attributable to other NexACT®
technology based products and indirect overhead related to research and
development, as compared to approximately $478,000 for Vitaros® during
the same period in 2007. Although our expenses for Vitaros® have
decreased in 2008, the decrease has been partially offset by an increase of
approximately $141,000 in salaries and benefits related to four new employee
hires during the first half of 2008. This increase is partially offset by a
decrease in temporary employee expense of approximately $118,000 as we converted
the temporary employees to full-time employees. Additionally, we have begun
to
spend modestly on the early stage development of our topical treatment for
psoriasis. During the second quarter of 2008 we have spent approximately
$101,000 on the psoriasis project. We will continue to spend modestly on the
early stage products under development and do
not
intend to trigger the approximately $800,000 in direct expenditures budgeted
until we have significantly improved our cash position.
23
General
and Administrative Expenses.
Our
general and administrative expenses were $1,193,379 during the second quarter
of
2008 as compared to $1,143,930 during the same period in 2007. The slight
increase is primarily due to an increase in salaries and stock compensation
expense of approximately $136,000 due to the addition of our Chief Operating
Officer in late 2007 and the appointment of our Chief Executive Officer in
June
2007. The increases were partially offset by a reduction in consulting fees
of
approximately $75,000 as our Chief Operating Officer and Chief Executive Officer
have taken over most of the responsibilities handled by consultants in 2007.
Interest
Expense, Net.
We had
net interest expense of $538,554 during the second quarter of 2008, as compared
to $15,793 during the same period in 2007. The increase is primarily due to
the
interest expense on the $3 million mortgage note executed in October 2007 as
discussed in Note 6 of the Consolidated Financial Statements and amortization
of
$461,291 of the note discount in 2008 as a result of writing off the balance
remaining of the note discount upon repayment of the $3 million mortgage note
on
June 30, 2008. Interest income was not significant in either period.
Net
Loss.
The net
loss was $1,628,723 or $0.02 per share and $1,991,021 or $0.02 per share in
the
second quarter of 2008 and 2007, respectively. The decrease is primarily
attributable to the increase in revenue as a result of the $750,000 in revenue
recognized as a result of the milestone payment received from Novartis during
the first quarter and the recognition of $166,667 in revenue related to the
up-front payment received in November 2007 from Warner, both as discussed in
Note 11 of the Consolidated Financial Statements.
Comparison
of Results of Operations Between the Six Months Ended June 30 of 2008 and of
2007.
Revenue,
principally license fee revenue.
We
recorded $2,151,399 in revenue during the first half of 2008, as compared to
$570,376 in revenue during the first half of 2007. The increase in revenue
is
primarily due to the $1,250,000 in revenue recognized related to the $1.5
million milestone payment received from Novartis on March 4, 2008 as discussed
in Note 11 of the Consolidated Financial Statements. Additionally, the increase
in revenue in 2008 is the result of the $333,334 in revenue recognized in 2008
attributable to the up-front payment received in November 2007 from Warner
as
discussed in Note 11 of the Consolidated Financial Statements.
Research
and Development Expenses.
Our
research and development expenses for the first half of 2008 and 2007 were
$2,265,493 and $2,192,598, respectively. Research and development expenses
in
the first half of 2008 included approximately $693,000 attributable to
Vitaros® and
the
balance attributable to other NexACT®
technology based products and indirect overhead related to research and
development, as compared to approximately $813,000 for Vitaros® during
the same period in 2007. Although our expenses for Vitaros® have
decreased in 2008, the modest increase in research and development expenses
is
attributable to an increase of approximately $278,000 in salaries and benefits
related to four new hires during the first half of 2008. This increase is
partially offset by a decrease in temporary employee expense of approximately
$160,000 as we converted the temporary employees to full-time employees.
Additionally, we have begun to spend modestly on the early stage development
of
our topical treatment for psoriasis. During the first half of 2008 we have
spent
approximately $176,000 on the psoriasis project, to fund mostly internal
development efforts. We will continue to spend modestly on the early stage
products under development and do
not
intend to trigger the approximately $800,000 in mostly pre-clinical expenses
budgeted until we have significantly improved our cash position.
24
General
and Administrative Expenses.
Our
general and administrative expenses were $2,496,777 during the first half of
2008 as compared to $2,376,825 during the same period in 2007. The slight
increase is primarily due to an increase in salaries and stock compensation
expense of approximately $216,000 due to the addition of our Chief Operating
Officer in late 2007 and the appointment of our Chief Executive Officer in
June
2007. The increases were partially offset by a reduction in consulting fees
of
approximately $153,000 as our Chief Operating Officer and Chief Executive
Officer have taken over most of the responsibilities handled by consultants
in
2007.
Interest
Expense, Net.
We had
net interest expense of $660,039 during the second quarter of 2008, as compared
to $31,283 during the same period in 2007. The increase is primarily due to
the
interest expense on the $3 million mortgage note executed in October 2007 as
discussed in Note 6 of the Consolidated Financial Statements and amortization
of
$461,291 of the note discount in 2008 as a result of writing off the balance
remaining of the note discount upon repayment of the $3 million mortgage note
on
June 30, 2008. Interest income was not significant in either period.
Net
Loss.
The net
loss was $3,270,910 or $0.04 per share and $4,030,330 or $0.05 per share in
the
second quarter of 2008 and 2007, respectively. The decrease is primarily
attributable to the increase in revenue as a result of the $1,250,000 in revenue
recognized as a result of the milestone payment received from Novartis during
the first quarter and the recognition of $333,334 in revenue related to the
up-front payment received in November 2007 from Warner, both as discussed in
Note 11 of the Consolidated Financial Statements.
25
ITEM 3. |
QUALITATIVE
AND QUANTITATIVE DISCLOSURES ABOUT MARKET
RISK
|
There
have been no material changes to our exposures to market risk since December
31,
2007.
ITEM 4. |
CONTROLSAND
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
12, 2008.
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 12, 2008
with the exception of the following:
We
continue to require external financing to fund our
operations.
While
we
expect our patent on NM100060 to be allowed during the third quarter of 2008,
triggering a $3.5 million payment from Novartis and, depending upon the results
of the Phase 3 program for NM100060, an additional up to $16 million before
the
end of 2008, there is no assurance that we will receive either such payment
in
2008, if at all. As such, we currently continue to depend upon external
financing, as described below, to fund our operations, and there is no assurance
that such financing will be available in the future.
26
On
May
12, 2008, we entered into a Binding Commitment for Credit Line (the
“Commitment”) with Southpoint Capital Advisors, LP (the “Lender”). Pursuant to
the Commitment, we established a $3 million credit line (the “Credit Line”) with
the Lender, which expires on December 31, 2008. We may draw down (“Draw Down”)
on the Credit Line up to five times during the term of the Credit Line, and
Draw
Downs may not exceed $600,000 in any 30 day period. In addition, we may only
Draw Down when the Company’s cash and cash equivalents are below $1 million, and
we must give the Lender at least 5 days’ notice prior to any Draw Down. In the
event the results from the Phase 3 trials on our anti-fungal product are
negative, further Draw Downs on the Credit Line will be prohibited.
On
June
30, 2008, we entered into a Purchase Agreement (the “Agreement”) with Tail Wind
Fund Ltd. and Solomon Strategic Holdings, Inc. (both Tail Wind Fund Ltd. and
Solomon Strategic Holdings, Inc. collectively referred to as “TWSS”). Pursuant
to the Agreement, we issued to TWSS 7% convertible notes (the “Notes”) due
December 31, 2011 (the “Due Date”) in the aggregate principal amount of $5.75
million. In connection therewith, we entered into a Mortgage, Security Agreement
and Assignment of Leases and Rents (the “Mortgage”) both dated June 30, 2008,
pursuant to which TWSS have been granted a security interest in our two East
Windsor, New Jersey properties. We used approximately $3.06 million of the
proceeds from this transaction to repay all of our obligations under a Purchase
Agreement with Twin Rivers Associates LLC, dated October 26, 2007, which was
secured by a mortgage on the two East Windsor, New Jersey properties and such
mortgage was released upon repayment.
The
Notes
are convertible into shares of our Common Stock with $4.75 million convertible
at $2 per share on or before the Due Date and $1 million convertible at $1.75
per share on or before December 31, 2008. The Notes have a coupon rate of 7%
per
annum, which is payable at our option in cash or, with certain exceptions,
in
shares of Common Stock. If paid in shares of Common Stock, then the price will
be calculated at the lesser of $0.08 below or 95% of a five-day weighted average
of the market price of the Common Stock prior to the time of payment.
The
closing of these transactions in the second quarter of 2008, along with our
current cash reserves, provide sufficient funding for our operations through
2008.
ITEM 2. |
UNREGISTERED
SALES OF EQUITY SECURITIES AND USE OF
PROCEEDS
|
As
reported on a Form 8-K filed on July 3, 2008, on June 30, 2008 the Company
issued its 7% convertible notes due December 31, 2011. Such convertible notes
were offered and sold to two institutional investors pursuant to the exemption
from registration under the Securities Act of 1933 pursuant to section 4(2)
thereof.
27
ITEM 4. |
SUBMISSION
OF MATTERS TO A VOTE OF SECURITY
HOLDERS
|
Following
are the results of voting by stockholders present or represented by proxy at
the
Company's Annual Meeting of Stockholders, which was held on June 9,
2008:
ITEM
1.
ELECTION OF DIRECTORS. The stockholders elected Leonard A. Oppenheim and David
S. Tierney, MD, to serve as Class III directors, until the Annual Meeting in
2011, or until their successors are elected:
Name
of Director
|
Votes
For
|
Votes
Withheld
|
|||||
Leonard
A. Oppenheim
|
67,817,709
|
6,567,211
|
|||||
David
S. Tierney, MD
|
67,851,304
|
6,533,616
|
The
remaining members of the Board of Directors following the meeting are as
follows: Class II directors, Richard J. Berman and Arthur D. Emil, Esq., whose
terms expire in 2009, and Class I directors, Martin Wade, III, and Vivian H.
Liu, whose terms expire in 2010.
ITEM
2.
APPROVAL AND ADOPTION OF AN AMENDMENT OF THE NEXMED, INC. 2006 STOCK INCENTIVE
PLAN TO INCREASE THE NUMBER OF SHARES AUTHORIZED THEREUNDER FROM 3,000,000
TO
5,000,000 OF THE COMPANY’S COMMON STOCK. The matter was approved by the
stockholders by a vote of: For: 43,098,505; Against: 12,351,902; Abstain:
1,414,390; Broker Non-Vote: 17,520,123.
ITEM
3.
RATIFICATION OF APPOINTMENT OF INDEPENDENT ACCOUNTANTS. The stockholders
ratified the appointment of Amper, Politziner & Mattia, PC as the Company’s
independent registered public accounting firm for the year ending December
31,
2008 by a vote of: For: 72,177,374; Against: 681,565; Abstain:
1,525,981.
ITEM 5. |
OTHER
INFORMATION
|
As
reported on a Form 8-K filed on July 3, 2008, on June 30, 2008 the Company
issued its 7% convertible notes due December 31, 2011. Such convertible notes
were offered and sold to two institutional investors pursuant to the exemption
from registration under the Securities Act of 1933 pursuant to section 4(2)
thereof.
28
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.
|
29
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:
August 6, 2008
|
/s/
Mark Westgate
|
Mark
Westgate
|
|
Vice
President and Chief FinancialOfficer
|
30
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.
|
31