SEELOS THERAPEUTICS, INC. - Quarter Report: 2008 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,
2008.
|
Commission
file number 0-22245
NEXMED,
INC.
(Exact
Name of Issuer as Specified in Its Charter)
87-0449967
|
||
(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 ¨
Accelerated filer x
Non-accelerated filer ¨ (do
not
check if a smaller reporting company) Smaller reporting company ¨
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act). Yes 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
6, 2008, 84,174,489 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 September 30, 2008 and December 31,
2007
|
1
|
|
Unaudited
Consolidated Statements of Operations for the Three and Nine Months
Ended
September 30, 2008 and September 30, 2007
|
2 | |
Unaudited
Consolidated Statements of Cash Flows for the Nine Months Ended September
30, 2008 and September 30, 2007
|
3 | |
Notes
to Unaudited Consolidated Financial Statements
|
4 | |
Item
2.
|
Management's
Discussion and Analysis of Financial Condition and Results of
Operations
|
17 |
|
||
Item
3.
|
Quantitative
and Qualitative Disclosures about Market Risk
|
25 |
|
||
Item
4.
|
Controls
and Procedures
|
25 |
|
||
Part
II. OTHER INFORMATION
|
26 | |
Item
1.
|
Legal
Proceedings
|
26 |
|
||
Item
1A.
|
Risk
Factors
|
26 |
|
||
Item
6.
|
Exhibits
|
29 |
|
||
Signatures
|
30 | |
Exhibit
Index
|
31 |
PART
I. FINANCIAL INFORMATION
ITEM
1. FINANCIAL STATEMENTS
NexMed,
Inc.
Consolidated
Balance Sheets
September 30,
|
December 31,
|
||||||
2008
|
2007
|
||||||
(Unaudited)
|
|||||||
Assets
|
|||||||
Current
assets:
|
|||||||
Cash
and cash equivalents
|
$
|
1,437,165
|
$
|
2,735,940
|
|||
Short
term investments
|
-
|
750,000
|
|||||
Debt
issuance cost, net of accumulated amortization
|
|||||||
of
$40,218 and $7,565 - current portion
|
76,130
|
68,081
|
|||||
Prepaid
expenses and other assets
|
173,387
|
127,659
|
|||||
Total
current assets
|
1,686,682
|
3,681,680
|
|||||
Fixed
assets, net
|
6,594,709
|
6,956,986
|
|||||
Debt
issuance cost, net of accumulated amortization
|
|||||||
of
$36,189 and $3,782
|
68,502
|
34,040
|
|||||
Total
assets
|
$
|
8,349,893
|
$
|
10,672,706
|
|||
Liabilities,
convertible preferred stock and stockholders' equity
|
|||||||
Current
liabilities:
|
|||||||
Accounts
payable and accrued expenses
|
$
|
1,308,000
|
$
|
621,668
|
|||
Payroll
related liabilities
|
138,421
|
693,774
|
|||||
Deferred
revenue
|
-
|
953,528
|
|||||
Deferred
compensation - current portion
|
63,135
|
60,929
|
|||||
Convertible
notes payable - current portion
|
1,000,000
|
-
|
|||||
Total
current liabilities
|
2,509,556
|
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
|
951,768
|
999,345
|
|||||
Total
Liabilities
|
8,211,324
|
5,867,949
|
|||||
Commitments
and contingencies (Note 10)
|
|||||||
Stockholders'
equity:
|
|||||||
Common
stock, $.001 par value, 120,000,000
|
|||||||
shares
authorized, 84,174,489 and 83,063,002
|
|||||||
and
outstanding, respectively
|
84,176
|
83,065
|
|||||
Additional
paid-in capital
|
140,883,499
|
139,239,794
|
|||||
Accumulated
deficit
|
(140,829,106
|
)
|
(134,518,102
|
)
|
|||
Total
stockholders' equity
|
138,569
|
4,804,757
|
|||||
Total
liabilities and stockholder's equity
|
$
|
8,349,893
|
$
|
10,672,706
|
See
notes
to unaudited consolidated financial statements.
1
NexMed,
Inc.
Consolidated
Statements of Operations (Unaudited)
FOR THE THREE MONTHS
|
FOR THE NINE MONTHS ENDED
|
||||||||||||
ENDED
SEPTEMBER 30,
|
SEPTEMBER
30,
|
||||||||||||
2008
|
2007
|
2008
|
2007
|
||||||||||
Revenues,
principally license fee revenue
|
$
|
305,943
|
$
|
296,390
|
$
|
2,457,342
|
$
|
866,766
|
|||||
Operating
expenses
|
|||||||||||||
Research
and development
|
1,875,474
|
1,266,792
|
4,140,967
|
3,459,390
|
|||||||||
General
and administrative
|
1,327,260
|
1,037,421
|
3,824,037
|
3,414,246
|
|||||||||
Total
operating expenses
|
3,202,734
|
2,304,213
|
7,965,004
|
6,873,636
|
|||||||||
Loss
from operations
|
(2,896,791
|
)
|
(2,007,823
|
)
|
(5,507,662
|
)
|
(6,006,870
|
)
|
|||||
Interest
expense, net
|
(143,303
|
)
|
(54,555
|
)
|
(803,342
|
)
|
(85,838
|
)
|
|||||
Net
loss
|
(3,040,094
|
)
|
(2,062,378
|
)
|
(6,311,004
|
)
|
(6,092,708
|
)
|
|||||
Basic
and diluted loss per common share
|
$
|
(0.04
|
)
|
$
|
(0.02
|
)
|
$
|
(0.08
|
)
|
$
|
(0.07
|
)
|
|
Weighted
average common shares outstanding
|
|||||||||||||
used
for basic and diluted loss per share
|
83,934,221
|
82,700,287
|
83,513,897
|
81,710,215
|
See
notes
to unaudited consolidated financial statements.
2
NexMed,
Inc.
Consolidated
Statements of Cash Flows (Unaudited)
FOR THE NINE MONTHS ENDED
|
|||||||
SEPTEMBER
30,
|
|||||||
2008
|
2007
|
||||||
Cash
flows from operating activities
|
|||||||
Net
loss
|
$
|
(6,311,004
|
)
|
$
|
(6,092,708
|
)
|
|
Adjustments
to reconcile net loss to net cash used in operating activities
|
|||||||
Depreciation
and amortization
|
369,346
|
488,238
|
|||||
Non-cash
interest, amortization of debt discount and
|
|||||||
deferred
financing costs
|
639,824
|
308,321
|
|||||
Non-cash
compensation expense
|
1,070,317
|
736,049
|
|||||
Loss
on disposal of fixed assets
|
21,918
|
7,911
|
|||||
Decrease
in other receivable
|
183,700
|
||||||
Increase
in prepaid expenses and other assets
|
(45,728
|
)
|
(981,876
|
)
|
|||
Increase
in accounts payable
|
|||||||
and
accrued expenses
|
686,332
|
66,812
|
|||||
Decrease
in payroll related liabilities
|
(555,353
|
)
|
(55,681
|
)
|
|||
Decrease
in deferred compensation
|
(45,371
|
)
|
(40,698
|
)
|
|||
Decrease
in deferred revenue
|
(953,528
|
)
|
(846,958
|
)
|
|||
Net
cash used in operating activities
|
(5,123,247
|
)
|
(6,226,890
|
)
|
|||
Cash
flows from investing activities
|
|||||||
Capital
expenditures
|
(28,988
|
)
|
(87,512
|
)
|
|||
Purchase
of marketable securities and short term investments
|
-
|
(3,000,000
|
)
|
||||
Proceeds
from sale of marketable securities and short term
investments
|
750,000
|
3,000,000
|
|||||
Net
cash provided by (used in) investing activities
|
721,012
|
(87,512
|
)
|
||||
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
|
204,692
|
|||||
Repayment
of note payable
|
(3,000,000
|
)
|
-
|
||||
Issuance
of convertible notes, net of debt issuance costs of
$105,804
|
5,643,711
|
-
|
|||||
Repayment
of convertible notes payable
|
-
|
(3,000,000
|
)
|
||||
Net
cash provided by (used in) financing activities
|
3,103,460
|
(2,797,418
|
)
|
||||
Net
decrease in cash and cash equivalents
|
(1,298,775
|
)
|
(9,111,820
|
)
|
|||
Cash
and cash equivalents, beginning of period
|
$
|
2,735,940
|
$
|
11,069,133
|
|||
Cash
and cash equivalents, end of period
|
$
|
1,437,165
|
$
|
1,957,313
|
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, 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 $140,829,106 at September 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 will
require additional financing to fund operations, including continued research,
development and clinical trials of the Company’s product candidates. 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.
Currently,
the Company’s common stock, par value $0.001 per share (the “Common Stock”)
trades on the Nasdaq Capital Market. On October 9, 2008, the Company was
notified by The Nasdaq Stock Market (“Nasdaq”) that for the previous 30
consecutive trading days the Company’s common stock has closed below the minimum
$1.00 per share requirement for continued inclusion by Marketplace Rule
4310(c)(8)(D). Pursuant to Marketplace Rule 4310(c)(8)(E), the Company was
provided 180 calendar days, or until April 7, 2009, to regain compliance.
On
October 22, 2008, the Company was notified by Nasdaq that effective on October
16, 2008 it had suspended enforcement of the bid price requirement until January
16, 2009. As such, since the Company had 174 days remaining in its compliance
period, it now has 174 days after January 16, 2009, or until July 13, 2009,
to
regain compliance.
4
Accordingly,
NexMed’s Common Stock must achieve a minimum bid price of $1.00 for a minimum of
10 consecutive days during the period ended July 13, 2009 in order to maintain
its listing on the Nasdaq Capital Market.
If
the
Company fails to achieve the minimum bid price requirement of the Nasdaq Capital
Market by July 13, 2009 or fails to maintain compliance with any other listing
requirements during this period, it may be delisted and the Company’s stock
would be considered a penny stock under regulations of the Securities and
Exchange Commission and would therefore be subject to rules that impose
additional sales practice requirements on broker-dealers who sell our
securities. The additional burdens imposed upon broker-dealers by these
requirements could discourage broker-dealers from effecting transactions in
the
Company’s Common Stock, which could severely limit the market liquidity of the
Common Stock and the ability to sell the Company’s securities in the secondary
market. In addition, if the Company fails to maintain its listing on Nasdaq
or
any other United States securities exchange, quotation system, market or
over-the-counter bulletin board, the Company will be subject to cash penalties
under investor rights agreements to which it is a party until a listing is
obtained.
In
May
2008, the Financial Accounting Standards Board (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 APB
14-1”), 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 liability 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 FSP APB 14-1 on its consolidated
financial statements as a result of its convertible debt, as discussed in Note
5
below.
2.
ACCOUNTING
FOR STOCK BASED COMPENSATION
In
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. In 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 $12.00. The maximum term under these
plans is 10 years.
5
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 nine months ended
September 30, 2008 and September 30, 2007 includes expense for all equity awards
granted during the three and nine months ended September 30, 2008 and September
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):
FOR THE THREE MONTHS
|
FOR THE NINE MONTHS ENDED
|
||||||||||||
ENDED
SEPTEMBER 30,
|
SEPTEMBER
30,
|
||||||||||||
2008
|
2007
|
2008
|
2007
|
||||||||||
Research
and development
|
9,814
|
6,087
|
28,592
|
31,053
|
|||||||||
General
and administrative
|
$
|
429,732
|
$
|
204,008
|
$
|
1,013,625
|
$
|
477,355
|
|||||
|
|||||||||||||
Stock-based
compensation expense
|
$
|
439,546
|
$
|
210,095
|
$
|
1,042,217
|
$
|
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 Common Stock.
6
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 month periods ended September 30, 2008 and September 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.
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,
2008, and related transactions for the nine month period then ended (unaudited):
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
|
2,878,090
|
7.14
years
|
$
|
0.87
|
$
|
-
|
2,576,686
|
$
|
0.83
|
$
|
-
|
|||||||||||
2.00
- 3.99
|
139,250
|
2.60
years
|
2.83
|
-
|
139,250
|
2.83
|
-
|
|||||||||||||||
4.00
- 5.50
|
373,651
|
3.89
years
|
4.65
|
-
|
373,651
|
4.65
|
-
|
|||||||||||||||
7.00
- 12.00
|
18,000
|
1.70
years
|
8.67
|
-
|
18,000
|
8.67
|
-
|
|||||||||||||||
3,408,991
|
5.41
years
|
$
|
1.40
|
$
|
-
|
3,107,587
|
$
|
1.42
|
$
|
-
|
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
|
$
|
43,270
|
|||||||
Forfeited
|
(5,850
|
)
|
$
|
11.78
|
-
|
||||||||
Outstanding
at September 30, 2008
|
3,408,991
|
$
|
1.40
|
5.41
years
|
$
|
0
|
|||||||
Vested
or expected to vest at
|
|||||||||||||
September
30, 2008
|
3,190,475
|
$
|
1.40
|
5.41
years
|
$
|
0
|
|||||||
Exercisable
at September 30, 2008
|
3,107,587
|
$
|
1.42
|
5.15
years
|
$
|
0
|
No
options were granted during the nine months ended September 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 nine months ended September 30, 2008 and 2007
was $43,270 and $23,529, respectively. Cash received from option exercises
for
the nine months ended September 30, 2008 and September 30, 2007, was $39,750
and
$56,164, respectively.
Compensatory
Share Issuances
The
value
of restricted stock grants is calculated based upon the closing stock price
of
the Company’s common stock on the date of the grant. The value of the grant is
expensed over the vesting period of the grant in accordance with SFAS 123R
as
discussed above.
8
Principal
employee based compensation transactions for the nine months ended September
30,
2008 were as follows:
On
January 9, 2008 the Company issued awards of shares of Common Stock to each
non-employee Director as compensation for their services during the year ending
December 31, 2008. In lieu of cash compensation, the non-employee Directors
have
opted to receive, and the Board of Directors has approved, a full grant of
24,324 shares of Common Stock to each non-employee 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 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.
On
August
12, 2008, the Compensation Committee of the Company’s Board of Directors
approved a revised compensation package for the non-employee directors for
the
2008 calendar year. Each non-employee member of the Board received an additional
grant of 18,508 shares of the Company’s Common stock bringing the total 2008
shares granted to each non-employee director to 42,832. 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 $62,962, divided by the Price.
Of
the
42,832 shares being granted to each independent Director, 3,569 of such shares
will vest each month during calendar 2008. As such, for the nine months ended
September 30, 2008, 32,124 shares vested and were issued to each non-employee
Director.
The
Compensation Committee also approved a revised compensation package for Richard
Berman for his annual service as Chairman of the Board. Mr. Berman received
an
additional grant of 57,835 shares of Common Stock bringing the total 2008 shares
granted to him to 82,159. The number of the full grant of shares was calculated
based on the amount of cash Mr. Berman would have received for annual service
as
Chairman of the Board, or $120,773, divided by the Price. Of the 82,159 shares
being granted, 6,846 of such shares will vest each month during calendar 2008.
As such, for the nine months ended September 30, 2008, 61,619 shares vested
and
were issued to Mr. Berman.
Also,
as
part of the revised compensation package, the Board approved a one-time grant,
vesting immediately, to the Chairmen and members of the various committees
of
the Board for their annual service. As such, the following shares of Common
Stock were issued to the non-employee Directors on August 12, 2008:
David
Tierney received 50,000 shares as Chairman of the Scientific Advisory Board,
906
shares as a member of the Nominating Committee, and 906 shares as a member
of
the Compensation Committee. The number of the full grant of shares was
calculated based on the amount of cash Mr. Tierney would have received for
annual service as Chairman of the Scientific Advisory Board, member of the
Nominating Committee, and member of the Compensation Committee, or $34,013,
$1,333, and $1,333, respectively, divided by the Price.
9
Leonard
Oppenheim received 6,197 shares as the Chairman of the Audit Committee. The
number of the full grant of shares was calculated based on the amount of cash
Mr. Oppenheim would have received for annual service as Chairman of the Audit
Committee, or $9,111, divided by the Price.
Martin
Wade received 3,287 shares as the Chairman of the Compensation Committee, 1,209
shares as a member of the Audit Committee, and 906 shares as a member of the
Nominating Committee. The number of the full grant of shares was calculated
based on the amount of cash Mr. Wade would have received for annual service
as
Chairman of the Compensation Committee, member of the Audit Committee, and
member of the Nominating Committee, or $4,833, $1,778, and $1,333, respectively,
divided by the Price.
Arthur
Emil received 1,587 shares as Chairman of the Nominating Committee, 1,209 shares
as a member of the Audit Committee, and 906 shares as a member of the
Compensation Committee. The number of the full grant of shares was calculated
based on the amount of cash Mr. Emil would have received for annual service
as
Chairman of the Nominating Committee, member of the Audit Committee, and member
of the Compensation Committee, or $2,333, $1,778, and $1,333, respectively,
divided by the Price.
On
September 12, 2008, the Board of Directors approved new stock grants (“New Stock
Grants”) for Hemanshu Pandya, the Company’s Chief Operating Officer and Mark
Westgate, the Company’s Chief Financial Officer, with each grant comprised of
500,000 restricted shares of Common Stock. The two New Stock Grants will vest
in
two equal installments on June 30, 2009 and June 30, 2010, respectively,
provided that Mr. Pandya and Mr. Westgate remain in continuous and uninterrupted
service with the Company.
3. WARRANTS
A
summary
of warrant activity for the nine month period ended September 30, 2008 is as
follows:
Weighted
|
Weighted
|
|||||||||
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 September 30, 2008
|
12,118,044
|
$
|
1.23
|
1.94
years
|
||||||
Exercisable
at September 30, 2008
|
12,118,044
|
$
|
1.23
|
1.94
years
|
Cash
received from warrant exercises for the nine months ended September 30, 2008
and
September 30, 2007, was $420,000 and $148,528, respectively.
10
Warrants
to purchase 250,000 shares of Common Stock were issued in connection with a
Line
of Credit established on May 12, 2008 as discussed in Note 7 below.
Additionally,
2,663,400 warrants 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, 2008 and 2007, respectively, options to acquire 3,408,991 and
3,314,841 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 nine ended September 30, 2008 and 2007 was calculated
as follows (net loss / weighted average common shares outstanding):
FOR THE THREE MONTHS
|
FOR THE NINE MONTHS ENDED
|
||||||||||||
ENDED
SEPTEMBER 30,
|
SEPTEMBER
30,
|
||||||||||||
2008
|
2007
|
2008
|
2007
|
||||||||||
Net
loss
|
$ |
(3,040,094
|
)
|
$ |
(2,062,378
|
)
|
$ |
(6,311,004
|
)
|
$ |
(6,092,708
|
)
|
|
Weighted
average common shares outstanding
|
|||||||||||||
used
for basic and diluted loss per share
|
83,934,221
|
82,700,287
|
83,513,897
|
81,710,215
|
|||||||||
Basic
and diluted loss per common share
|
$
|
(0.04
|
)
|
$
|
(0.02
|
)
|
$
|
(0.08
|
)
|
$
|
(0.07
|
)
|
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 collateralized by the Company’s facility in East Windsor, New Jersey and
$4.75 million of the Notes are due on December 31, 2011 (the “Due
Date”) and
$1
million of the Notes are due on December 31, 2008. The Notes are due and payable
in cash or convertible into shares of 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 at the holders’ option. 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 of
the
stock issued will be the lesser of $0.08 below or 95% of the 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.
11
On
October 1, 2008, the Company paid $101,743 for interest on the Note for the
period June 30, 2008 through September 30, 2008.
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 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
nine months ended September 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 Common Stock as payment
of an aggregate of $25,000 in interest on the note.
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.
12
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
nine months ended September 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 could
draw down (“Draw Down”) on the Credit Line up to five times during the term of
the Credit Line, and Draw Downs could not exceed $600,000 in any 30 day period.
In addition, the Company could 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. The Commitment provided that if the
results from the Phase 3 trials on the Company’s anti-fungal product were
negative, further Draw Downs on the Credit Line would be prohibited.
The
Company could repay the Draw Downs in either shares of Common Stock or cash
at
the Lender’s option on December 31, 2008. If the Lender chose to be repaid with
Common Stock, the number of shares of Common Stock issued would have been 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.
For
the
nine months ended September 30, 2008, the Company recorded $68,850 of
amortization related to the debt issuance cost of the Credit Line. As of
September 30, 2008 there have been no Draw Downs under the
commitment.
13
On
August
26, 2008, the Company announced that Novartis had decided to not submit the
New
Drug Application (“NDA”) in the U.S. based on First Interpretable Results of the
Phase 3 trials on the Company’s anti-fungal product. As such, the Credit Line
was withdrawn by the Lender.
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 September 30, 2008, the Company
has accrued $1,014,903 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.
None
of
the net operating loss carry-forwards are limited by Internal Revenue Code
Section 382, however subsequent changes in the ownership of the Company may
trigger a limitation in the ability to utilize the net operating loss
carry-forwards each year.
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. FIN 48 has 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 with a clinical research
organization (“CRO”) 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
September 30, 2008, the clinical research agreements were cancelled as it was
determined that the one-year open-label study would no longer be required by
the
FDA for regulatory approval of Vitaros®.
As
such, a cancellation fee of approximately $892,000 was accrued at September
30,
2008. Pursuant to the terms of the clinical research agreement, the cancellation
fee is not payable until December 15, 2008. Additionally, the penalty will
be
reduced by an amount equal to 50% of any clinical research fees billed to the
Company by the CRO between September 30, 2008 and December 31,
2008.
14
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
was 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 nine months ended September 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 International Pharmaceutical Ltd. (“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 was
the
estimated performance period for Novartis to complete the remaining preclinical
studies. Accordingly, for the nine months ended September 30, 2008, the Company
recognized licensing revenue of $564,639 related to the initial cash payment
at
signing.
15
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 Phase 3 clinical trials for NM100060
triggered a $3 million milestone payment from Novartis, the agreement also
provided 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 was being recognized on a straight-line basis over the six month period
to complete the Phase 3 clinical trial. Accordingly, for the nine months ended
September 30, 2008, the Company recognized licensing revenue of $1.25 million
related to the $1.5 million milestone payment.
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 would continue to fulfill
its obligations pursuant to the agreement and (a) transfer the Investigational
New Drug application (“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 New Drug Application (“NDA”) for NM100060. The IND
was transferred to Novartis on July 24, 2008.
In
July
2008, Novartis
completed testing for the Phase 3 clinical trials for NM100060
required
for the filing of the NDA in the U.S. On August 26, 2008, the Company announced
that Novartis had decided not to submit the NDA in the U.S. based on First
Interpretable Results of the Phase 3 trials. As a result of this decision,
the
Company will not receive the $6 million for positive Phase 3 results. The $7
million milestone payment for the filing of the NDA has been postponed
indefinitely.
On
October 17, 2008, the Company received a Notice of Allowance for its U.S. patent
covering NM100060. Pursuant to the license agreement, the payment of the
issuance fee for an approved patent claim on NM100060 triggered the $2 million
patent milestone payment from Novartis. Additionally, $1.5 million, which
represents the remaining 50% of the patient enrollment milestone that was
triggered over eight months ago and held by Novartis until the patent milestone
was achieved, also became due and payable. As such, on October 22, 2008 the
Company invoiced Novartis a total of $3.5 million for these two milestone
payments. The Company received the payment of $3.5 million from Novartis on
October 30, 2008.
Novartis
has confirmed that it intends to complete patient testing in the ongoing
comparator study which they had initiated in March 2007 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 available in mid-2009. As of now, the Company cannot
confirm Novartis’ plan for the product. If Novartis decides to terminate the
global licensing agreement, which it can do at any time, the rights to NM100060
would revert back to us with no compensation for termination.
16
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 herein and
in
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.
17
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 the 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 only $1.5 million from Novartis on March 4, 2008.
On
October 17, 2008, the U.S. Patent and Trademark Office issued the Notice of
Allowance on our patent application for NM100060. Upon payment of the patent
issuance fee on October 22, 2008, we triggered a $2 million milestone payment
from Novartis. Additionally, we also invoiced Novartis $1.5 million for the
remaining 50% of the patient enrollment milestone that was held by Novartis
as
discussed previously. We received the payment of $3.5 million from Novartis
on
October 30, 2008.
In
July
2008, Novartis
completed testing for the Phase 3 clinical trials for NM100060. The
Phase
3 program required for the filing of the NDA in the U.S. for NM100060 consisted
of two pivotal, randomized, double-blind, placebo-controlled studies. The
parallel 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. On August 26, 2008, we announced
that based on First Interpretable Results of these two Phase 3 studies, Novartis
had decided not to submit the NDA at this time. As a result of this decision,
we
will not receive the $6 million for positive Phase 3 results. The $7 million
milestone payment for the filing of the NDA has been postponed indefinitely.
Novartis
has confirmed that it intends to complete patient testing in the ongoing
comparator study which they had initiated in March 2007 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 available in mid-2009. As of now, we cannot confirm
Novartis’ plan for the product. If Novartis decides to terminate the global
licensing agreement, which it can do at any time, the rights to NM100060 would
revert back to us with no compensation for termination.
18
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 action letter (the “Action 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 (“TgAC”) mouse carcinogenicity
study which NexMed completed in 2002. The TgAC concern raised by the FDA is
product specific, and does not affect the dermatological products in our
pipeline, specifically NM100060.
On
October 15, 2008, we met with the FDA to discussthe
major
deficiencies cited in the Action Letter and to reach consensus on the necessary
actions for addressing these deficiencies for our Vitaros®
NDA.
Several key regulatory concerns were addressed and agreements were reached
at
the meeting. The FDA agreed to our request for a review of this assessment
by
the Carcinogenicity Advisory Committee (CAC) prior to our Class 2 resubmission
in reply to the Action Letter. The CAC will review the 2 two year
carcinogenicity studies which were recently completed. We will also submit
a
briefing package to the CAC for review, which incorporates the results from
the
entire carcinogenicity program, relevance and utility of the TgAC model and
concludes that the weight of evidence of the entire carcinogenicity program
can
alleviate the FDA’s concerns over the positive results from the TgAC study.
NexMed plans to submit this briefing package for CAC review by the end of the
year. In terms of an assessment of the transfer to the partner of the
NexACT®
technology, the FDA agreed with our proposal to conduct one Phase 1 study in
healthy volunteers with the design of the trial to be determined. Finally,
in
terms of the assessment of transmission of sexually transmitted diseases, the
FDA and Nexmed agreed on a plan to conduct one animal study with the animal
model to be determined. The FDA also confirmed the revision on the status of
our
manufacturing facility from “withhold” to “acceptable”, based on our adequately
addressing the deficiencies cited in their Pre-Approval Inspection (“PAI”) of
our facility in January 2008. The purpose of the PAI is 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. It was also made clear by the FDA that
a
one-year open-label safety study would no longer be required for regulatory
approval.
19
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
and
manufacturing of Vitaros®.
While
Warner intends to manufacture Vitaros®
in the
future, our facility is listed as the manufacturing and quality control
laboratory in the NDA and may be the initial site for commercial manufacturing
of Vitaros®
upon its
approval for commercialization. However, Warner could also decide to shift
manufacturing for Vitaros®
to a
third party facility.
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. Based on our discussions to date with Health Canada, we expect to
receive a Letter of Deficiencies which will cite similar regulatory issues
as
previously cited by the FDA. We will have up to 90 days to reply to the Letter
of Deficiencies when it is received from Health Canada, and believe that we
will
be able to satisfactorily address the concerns cited. However, 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 Marketing Authorization
Application (“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.
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.
20
We
have
experienced net losses and negative cash flows from operations each year since
our inception. Through September 30, 2008, we had an accumulated deficit of
$140,829,106. 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
September 30, 2008 we had cash and cash equivalents and short term investments
of approximately $1.4 million as compared to $3.5 million at December 31, 2007.
Our cash used in operations in the first nine months 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 $493,000 in direct costs
to
support our NDA and NDS filings for Vitaros®,
$76,000 in direct expenses on our psoriasis project,
$95,000
for legal fees in connection with a patent lawsuit whereby we are the plaintiff
suing for patent infringement on our herpes treatment medical device, and
approximately $106,000 in closing costs related to the convertible notes closed
on June 30 as discussed in Note 5 of the Consolidated Financial Statements.
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 on June 30, 2008 as discussed in
Note
5 of the Consolidated Financial Statements. On October 22, 2008, we triggered
a
$2 million milestone with Novartis which also resulted in the release of the
balance of $1.5 million patient enrollment milestone payment. The total $3.5
million payment was received from Novartis on October 30, 2008.
On
September 9, 2008, we were approved by the State of New Jersey to sell a portion
of our state tax credits and net operating losses (“NOLs”) pursuant to the
Technology Tax Certificate Transfer Program (“Program”). We currently have
approximately $1.9 million in tax credits and NOLs available to sell. We have
not yet been informed of the exact amount of tax credits and NOLs that we will
be permitted to sell for 2008 but based on a recent discussion with the Program
administrators; we expect to receive at least $600,000 in net proceeds from
such
sale. For the past three years, we were approved to sell NOLs in the amounts
of
$905,515 in 2007, $637,525 in 2006, and $540,580 in 2005, and received net
proceeds of $805,909, $567,397, and $481,116 respectively.
21
Our
current cash reserves as of the date of this report combined with the $3.5
million received from Novartis on October 30, 2008 along with the anticipated
proceeds from the sale of NOLs for 2008 should provide us with sufficient cash
to fund our operations through the second quarter of 2009 based on our current
monthly operating expenditures of
$525,000
and the $1 million mortgage payment due on December 31, 2008 as discussed in
Note 5 of the Consolidated Financial Statements. However, we are evaluating
ways
to cut our monthly expenditures with the goal of reducing our current monthly
operating expenses by 30% or to $350,000 per month. Measures being considered
include selling our facility, freezing expenses, and further limiting our
research and development activities. If we are successful in reducing our
monthly operating expenses to $350,000 per month by the end of 2008 and
renegotiating or refinancing our mortgage payment due on December 31, 2008
our
current cash reserves should provide us with sufficient cash to fund our
operations through 2009, even if we do not receive any further cash infusions
from our current or future licensing partners.
At
September 30, 2008, we had $1,308,000 in accounts payable and accrued expenses
as compared to $621,668 at December 31, 2007. The increase is attributable
to
approximately $892,000 accrued and expensed at September 30, 2008 for a
cancellation fee related to the cancellation of a clinical research agreement
for a one-year open-label study that will no longer be required by the FDA
for
regulatory approval of Vitaros®,
as
discussed in Note 10 of the Consolidated Financial Statements.
At
September 30, 2008, we had $138,421 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
September 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, we 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 September 30, 2008, there is no remaining balance
due to the holder of the note.
To
date,
we have spent approximately $71.7 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.
22
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 September 30, 2008
and
2007.
Revenue,
principally license fee revenue.
We
recorded $305,943 in revenue during the third quarter of 2008, as compared
to
$296,390 in revenue during the second quarter of 2007.
Research
and Development Expenses.
Our
research and development expenses for the third quarter of 2008 and 2007 were
$1,875,474 and $1,266,792, respectively. Research and development expenses
in
the third quarter of 2008 increased primarily due to the
expense of approximately $892,000 for
a
cancellation fee related to the cancellation of a clinical research agreement
for a one-year open-label study that will no longer be required by the FDA
for
regulatory approval of Vitaros®
as discussed in Note 10 of the Consolidated Financial Statements. This increase
was partially offset by reduced spending in 2008 on our development programs
including
approximately $178,000 attributable to Vitaros®,
as
compared to approximately $521,000 for Vitaros® during
the same period in 2007. We
have
continued to spend modestly on the early stage development of our topical
treatment for psoriasis. During the third quarter of 2008 we have spent
approximately $95,000 on the psoriasis project. We have budgeted approximately
$800,000 in direct expenditures in 2008 for early stage product development.
However, we will continue to spend modestly on these products and do
not
intend to trigger the direct expenditures budgeted until we have significantly
improved our cash position.
General
and Administrative Expenses.
Our
general and administrative expenses were $1,327,260 during the third quarter
of
2008 as compared to $1,037,421 during the same period in 2007. The increase
is
primarily due to an increase in stock compensation expense of approximately
$266,000 due to the addition of our Chief Operating Officer in late 2007 and
the
revised stock compensation package for directors approved in August, 2008
whereby the annual fees for service were increased for non-employee Directors.
Interest
Expense, Net.
We had
net interest expense of $143,303 during the third quarter of 2008, as compared
to $54,555 during the same period in 2007. The increase is primarily due to
the
interest on $5,750,000 principal amount of convertible notes during the third
quarter of 2008 as compared to interest expense on lesser debt of $2,000,000
during the same period in 2007.
23
Net
Loss.
The net
loss was $3,040,094 or $0.04 per share and $2,062,378 or $0.02 per share in
the
third quarter of 2008 and 2007, respectively. The increase in net loss is
primarily attributable to the third quarter 2008 expense of $892,000
for
a
cancellation fee related to the cancellation of a clinical research agreement
for a one-year open-label study that will no longer be required by the FDA
for
regulatory approval of Vitaros®.
We also had an increase in stock compensation expense in the third quarter
of
2008 as a result of the
addition of our Chief Operating Officer in late 2007 and the revised stock
compensation package for directors approved in August, 2008 whereby the annual
fees for service were increased for non-employee directors.
Comparison
of Results of Operations Between the Nine Months Ended September 30 of 2008
and
of 2007.
Revenue,
principally license fee revenue.
We
recorded $2,457,342 in revenue at September 30, 2008, as compared to $866,766
in
revenue during the same period in 2007. The increase in revenue is primarily
due
to the $1.5 million in revenue recognized on receipt of a milestone payment
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
$390,000 in revenue recognized in 2008 attributable to the up-front payment
of
$500,000 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 at September 30, 2008 and 2007 were $4,140,967
and $3,459,390, respectively. Research and development expenses in the third
quarter of 2008 increased primarily due to the
expense of approximately $892,000 for
a
cancellation fee related to the cancellation of a clinical research agreement
for a one-year open-label study that will no longer be required by the FDA
for
regulatory approval of Vitaros®
as discussed in Note 10 of the Consolidated Financial Statements. This increase
was partially offset by reduced spending in 2008 on our development programs
including
approximately $871,000 attributable to Vitaros®,
as
compared to approximately $1.4 million for Vitaros® during
the same period in 2007. We
have
begun to spend modestly on the early stage development of our topical treatment
for psoriasis. As of September 30, 2008 we have spent approximately $271,000
on
the psoriasis project, to fund mostly internal development efforts. We have
budgeted approximately $800,000 in direct expenditures in 2008 for early stage
product development. However, we will continue to spend modestly on these
products and do
not
intend to trigger the direct expenditures budgeted until we have significantly
improved our cash position.
General
and Administrative Expenses.
Our
general and administrative expenses were $3,824,037 for the nine months of
operations in 2008 as compared to $3,414,246 during the same period in 2007.
The
increase is primarily due to an increase in stock compensation expense of
approximately $373,000 due to the addition of our Chief Operating Officer in
late 2007 and the revised stock compensation package for Directors approved
in
August, 2008 whereby the annual fees for service were increased for non-employee
Directors.
24
Interest
Expense, Net.
We had
net interest expense of $803,342 during the nine months of 2008, as compared
to
$85,838 during the same period in 2007. The increase is primarily due to the
interest expense on $5,750,000 principal amount of convertible notes issued
in
June 2008 and the $3 million mortgage note executed in October 2007 and paid
in
June 2008 as discussed in Note 6 of the Consolidated Financial Statements and
amortization of $461,291 of the note discount on the mortgage note in 2008
as a
result of writing off the balance remaining of such note discount upon repayment
of the note on June 30, 2008. Interest income was not significant in either
period.
Net
Loss.
The net
loss was $6,311,004 or $0.08 per share and $6,092,708 or $0.07 per share for
the
nine months of operations in 2008 and 2007, respectively. The increase is
primarily attributable to the increase in research and development expenses
and
general and administrative expenses as well as an increase of approximately
$720,000 in interest expense in 2008 as discussed above. This increase in 2008
expenses was partially offset by the increase in revenue in 2008 primarily
due to the $1.5 million milestone payment received from Novartis on March 4,
2008 and the $390,000 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.
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.
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.
25
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, which may not
be
available.
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 consisted of two pivotal, randomized, double-blind,
placebo-controlled studies. The parallel 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. On August
26,
2008, we announced that based on First Interpretable Results of these two Phase
3 studies, Novartis had decided not to submit the NDA at this time. As a result
of this decision, we will not receive the $6 million for positive Phase 3
results. The $7 million milestone payment for the filing of the NDA has been
postponed indefinitely.
On
October 22, 2008, we triggered a $2 million milestone with Novartis which also
resulted in the release of the balance of $1.5 million patient enrollment
milestone payment. The total $3.5 million payment was received from Novartis
on
October 30, 2008. On September 9, 2008, we were approved by the State of New
Jersey to sell a portion of our state tax credits and net operating losses
(NOLs) pursuant to the Technology Tax Certificate Transfer Program (Program).
We
currently have approximately $1.9 million in tax credits and NOLs available
to
sell. We have not yet been informed of the exact amount of tax credits and
NOLs
that we will be permitted to sell for 2008, but based on a recent discussion
with the Program administrators, we expect to receive at least $600,000 in
net
proceeds from such sale. For the past three years, we were approved to sell
NOLs
in the amounts of $905,515 in 2007, $637,525 in 2006, and $540,580 in 2005,
and
received net proceeds of $805,909, $567,397, and $481,116
respectively.
26
Our
current cash reserves as of the date of this report combined with the $3.5
million received from Novartis on October 30, 2008 along with the anticipated
proceeds from the sale of NOLs for 2008 should provide us with sufficient cash
to fund our operations through the second quarter of 2009 based on our current
monthly operating expenditures of
$525,000
and the $1 million mortgage payment due on December 31, 2008 as discussed in
Note 5 of the Consolidated Financial Statements. However, we are evaluating
ways
to cut our monthly expenditures with the goal of reducing our current monthly
operating expenses by 30% or to $350,000 per month. Measures being considered
include selling our facility, freezing expenses, and further limiting our
research and development activities. If we are successful in reducing our
monthly operating expenses to $350,000 per month by the end of 2008 and
renegotiating or refinancing our mortgage payment due on December 31, 2008
our
current cash reserves should provide us with sufficient cash to fund our
operations through 2009 even if we do not receive any further cash infusions
from our current or future licensing partners.
Our
stock may be delisted from Nasdaq, which may make it more difficult for you
to
sell your shares.
Currently,
our Common Stock trades on the Nasdaq Capital Market. On October 9, 2008, we
were notified by The Nasdaq Stock Market (“Nasdaq”) that for the previous 30
consecutive trading days our common stock has closed below the minimum $1.00
per
share requirement for continued inclusion by Marketplace Rule 4310(c)(8)(D).
Pursuant to Marketplace Rule 4310(c)(8)(E), we were provided 180 calendar days,
or until April 7, 2009, to regain compliance.
On
October 22, 2008, we were notified by Nasdaq that effective October 16, 2008
it
had suspended enforcement of the bid price requirement until January 16, 2009.
As such, since we had 174 days remaining in our compliance period, we now have
174 days from January 16, 2009, or until July 13, 2009, to regain
compliance.
Accordingly,
our Common Stock must achieve a minimum bid price of $1.00 for a minimum of
10
consecutive days during the period ended July 13, 2009 in order to maintain
our
listing on the Nasdaq Capital Market.
If
we
fail to achieve the minimum bid price requirement of the Nasdaq Capital Market
by July 13, 2009 or fail to maintain compliance with any other listing
requirements during this period, we may be delisted and our stock would be
considered a penny stock under regulations of the Securities and Exchange
Commission and would therefore be subject to rules that impose additional sales
practice requirements on broker-dealers who sell our securities. The additional
burdens imposed upon broker-dealers by these requirements could discourage
broker-dealers from effecting transactions in our Common Stock, which could
severely limit the market liquidity of the Common Stock and your ability to
sell
our securities in the secondary market. In addition, if we fail to maintain
our
listing on Nasdaq or any other United States securities exchange, quotation
system, market or over-the-counter bulletin board, we will be subject to cash
penalties under investor rights agreements to which we are a party until a
listing is obtained.
Instability
and volatility in the financial markets could have a negative impact on our
business, financial condition, results of operations and cash
flows.
During
recent months, there has been substantial volatility and a decline
in financial markets due at least in part to the deteriorating global
economic environment. In addition, there has been substantial uncertainty in
the
capital markets and access to financing is uncertain. These conditions
could have an adverse
effect on our industry, licensing partners, and business, including our
financial condition, results of operations and cash
flows.
27
To
the
extent that we do not generate sufficient cash from operations, we may need
to
incur indebtedness to finance plans for growth. Recent turmoil in the credit
markets and the potential impact on the liquidity of major financial
institutions may have an adverse effect on our ability to fund our business
strategy through borrowings, under either existing or newly created instruments
in the public or private markets on terms that we believe to be reasonable,
if
at all.
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:
November 10, 2008
|
/s/
Mark Westgate
|
Mark
Westgate
|
|
Vice
President and Chief Financial
|
|
Officer
|
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