SEELOS THERAPEUTICS, INC. - Quarter Report: 2008 March (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 March 31,
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 __ Accelerated filer xNon-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 May
8,
2008, 83,620,316 shares of Common Stock, par value $0.001 per share, were
outstanding.
Table
of
Contents
Page
|
|||
Part
I. FINANCIAL INFORMATION
|
|||
Item
1.
|
Financial
Statements
|
1
|
|
Consolidated
Balance Sheets at March 31, 2008 (unaudited) and December 31,
2007
|
1
|
||
Unaudited
Consolidated Statements of Operations for the Three Months Ended
March 31,
2008 and March 31, 2007
|
2
|
||
Unaudited
Consolidated Statements of Cash Flows for the Three Months Ended
March 31,
2008 and March 31, 2007
|
3
|
||
Notes
to Unaudited Consolidated Financial Statements
|
4
|
||
Item
2.
|
Management's
Discussion and Analysis of Financial Condition and Results of
Operations
|
13
|
|
Item
3.
|
Quantitative
and Qualitative Disclosures about Market Risk
|
22
|
|
Item
4.
|
Controls
and Procedures
|
22
|
|
Part
II. OTHER INFORMATION
|
|||
Item
1.
|
Legal
Proceedings
|
22
|
|
Item
1A.
|
Risk
Factors
|
23
|
|
Item
2.
|
Unregistered
Sales of Equity Securities and Use of Proceeds
|
23
|
|
Item
6.
|
Exhibits
|
24
|
|
Signatures
|
25
|
||
Exhibit
Index
|
26
|
PART
I. FINANCIAL INFORMATION
ITEM
1. FINANCIAL STATEMENTS
NexMed,
Inc.
Consolidated
Balance Sheets
March
31,
|
December
31,
|
||||||
2008
|
2007
|
||||||
(Unaudited)
|
|||||||
Assets
|
|||||||
Current
assets:
|
|||||||
Cash
and cash equivalents
|
$
|
2,382,559
|
$
|
2,735,940
|
|||
Short
term investments
|
-
|
750,000
|
|||||
Debt
issuance cost, net of accumulated amortization
|
|||||||
of
$22,694 and $7,565 - current portion
|
68,081
|
68,081
|
|||||
Prepaid
expenses and other assets
|
115,849
|
127,659
|
|||||
Total
current assets
|
2,566,489
|
3,681,680
|
|||||
Fixed
assets, net
|
6,841,818
|
6,956,986
|
|||||
Debt
issuance cost, net of accumulated amortization of $5,673 and
$3,782
|
17,020
|
34,040
|
|||||
Total
assets
|
$
|
9,425,327
|
$
|
10,672,706
|
|||
Liabilities
and stockholders' equity
|
|||||||
Current
liabilities:
|
|||||||
Accounts
payable and accrued expenses
|
$
|
604,249
|
$
|
621,668
|
|||
Payroll
related liabilities
|
151,430
|
693,774
|
|||||
Deferred
revenue
|
1,504,542
|
953,528
|
|||||
Deferred
compensation - current portion
|
61,656
|
60,929
|
|||||
Total
current liabilities
|
2,321,877
|
2,329,899
|
|||||
Long
Term liabilities:
|
|||||||
Note
payable, net of debt discount of $384,413 and $461,295
|
2,615,587
|
2,538,705
|
|||||
Deferred
compensation
|
983,673
|
999,345
|
|||||
Total
Liabilities
|
5,921,137
|
5,867,949
|
|||||
Commitments
and contingencies (Note 7)
|
|||||||
Stockholders'
equity:
|
|||||||
Preferred
stock, $.001 par value, 10,000,000 shares authorized, none issued
and
outstanding
|
-
|
-
|
|||||
Common
stock, $.001 par value, 120,000,000 shares authorized, 83,148,407
and
83,063,002 issued and outstanding, respectively
|
83,150
|
83,065
|
|||||
Additional
paid-in capital
|
139,581,329
|
139,239,794
|
|||||
Accumulated
deficit
|
(136,160,289
|
)
|
(134,518,102
|
)
|
|||
Total
stockholders' equity
|
3,504,190
|
4,804,757
|
|||||
Total
liabilities and stockholders' equity
|
$
|
9,425,327
|
$
|
10,672,706
|
See
notes to consolidated financial
statements.
|
1
NexMed,
Inc.
Consolidated
Statements of Operations (Unaudited)
FOR THE THREE MONTHS ENDED
|
|
||||||
|
|
MARCH 31,
|
|
||||
|
|
2008
|
|
2007
|
|
||
Revenues,
principally license fee revenue
|
$
|
951,787
|
$
|
286,959
|
|||
Operating
expenses
|
|||||||
Research
and development
|
1,169,091
|
1,077,883
|
|||||
General
and administrative
|
1,303,398
|
1,232,895
|
|||||
Total
operating expenses
|
2,472,489
|
2,310,778
|
|||||
Loss
from operations
|
(1,520,702
|
)
|
(2,023,819
|
)
|
|||
Other
expense
|
|||||||
Interest
expense, net
|
(121,485
|
)
|
(15,490
|
)
|
|||
Total
other expense
|
(121,485
|
)
|
(15,490
|
)
|
|||
Net
loss
|
(1,642,187
|
)
|
(2,039,309
|
)
|
|||
Basic
and diluted loss per share
|
$
|
(0.02
|
)
|
$
|
(0.03
|
)
|
|
Weighted
average common shares outstanding used for basic and diluted loss
per
share
|
83,094,347
|
80,803,109
|
|||||
See
notes to consolidated financial
statements.
|
2
NexMed,
Inc.
Consolidated
Statements of Cash Flows (Unaudited)
FOR THE THREE MONTHS ENDED
MARCH 31,
|
|||||||
2008
|
2007
|
||||||
Cash
flows from operating activities
|
|||||||
Net
loss
|
$
|
(1,642,187
|
)
|
$
|
(2,039,309
|
)
|
|
Adjustments
to reconcile net loss to net cash used in operating
activities
|
|||||||
Depreciation
and amortization
|
126,595
|
171,798
|
|||||
Non-cash
interest, amortization of debt discount and deferred financing
costs
|
93,903
|
68,229
|
|||||
Non-cash
compensation expense
|
301,870
|
358,313
|
|||||
Loss
on disposal of fixed assets
|
2,605
|
-
|
|||||
Decrease
in other receivable
|
-
|
183,700
|
|||||
Increase/(decrease)
in prepaid expenses and other assets
|
11,810
|
(31,027
|
)
|
||||
Increase/(decrease)
in deferred revenue
|
551,014
|
(282,319
|
)
|
||||
Decrease
in payroll related liabilities
|
(542,344
|
)
|
(33,842
|
)
|
|||
Decrease
in deferred compensation
|
(14,945
|
)
|
(40,698
|
)
|
|||
Increase/(decrease)
in accounts payable and accrued expenses
|
(17,419
|
)
|
105,863
|
||||
Net
cash used in operating activities
|
(1,129,098
|
)
|
(1,539,292
|
)
|
|||
Cash
flow from investing activities
|
|||||||
Capital
expenditures
|
(14,033
|
)
|
-
|
||||
Purchase
of short term investments
|
-
|
(3,000,000
|
)
|
||||
Proceeds
from sale of short term investments
|
750,000
|
1,500,000
|
|||||
Net
cash provided by (used in) investing activities
|
735,967
|
(1,500,000
|
)
|
||||
Cash
flow from financing activities
|
|||||||
Issuance
of common stock, net of offering costs
|
-
|
(2,110
|
)
|
||||
Proceeds
from exercise of stock options and warrants
|
39,750
|
135,689
|
|||||
Net
cash provided by financing activities
|
39,750
|
133,579
|
|||||
Net
decrease in cash and cash equivalents
|
(353,381
|
)
|
(2,905,713
|
)
|
|||
Cash
and cash equivalents, beginning of period
|
2,735,940
|
11,069,133
|
|||||
Cash
and cash equivalents, end of period
|
$
|
2,382,559
|
$
|
8,163,420
|
|||
See
notes to 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 three months ended March 31, 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 $136,160,289 at March 31, 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, which it is
actively pursuing, to fund operations, including continued research, development
and clinical trials of the Company’s product candidates. Although management
continues 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
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.
2. |
ACCOUNTING
FOR STOCK BASED COMPENSATION
|
During
December 1996, the Company adopted the NexMed, Inc. Stock Option and Long-Term
Incentive Compensation Plan (“the Incentive Plan”) and the NexMed, Inc.
Recognition and Retention Stock Incentive Plan (“the Recognition Plan”). A total
of 2,000,000 shares were set aside for these two plans. In May 2000, the
Stockholders approved an increase in the number of shares reserved for the
Incentive Plan and Recognition Plan to a total of 7,500,000. During June 2006,
the Company adopted the NexMed, Inc. 2006 Stock Incentive Plan. A total of
3,000,000 shares were set aside for the plan. Options granted under the
Company’s plans generally vest over a period of one to five years, with exercise
prices of currently outstanding options ranging from $0.55 to $16.25. The
maximum term under these plans is 10 years.
4
Effective
January 1, 2006, the Company adopted the provisions of Statement of Financial
Accounting Standards No. 123R, “Share-Based Payment” (“SFAS
123R”), which establishes the financial accounting and reporting standards
for stock-based compensation plans. SFAS 123R requires the measurement and
recognition of compensation expense for all stock-based awards made to employees
and directors, including employee stock options and restricted stock. Under
the
provisions of SFAS 123R, stock-based compensation cost is measured at the
grant date, based on the calculated fair value of the award, and is recognized
as an expense on a straight-line basis over the
requisite service period of the entire award (generally the vesting period
of
the award). The Company adopted the provisions of SFAS 123R as of January 1,
2006 using the modified prospective transition method. Under this transition
method, stock-based compensation expense for the three months ended March 31,
2008 and March 31, 2007 includes expense for all equity awards granted during
the three months ended March 31, 2008 and March 31, 2007 and prior, but not
yet
vested as of January 1, 2006, based on the grant date fair value estimated
in
accordance with the original provisions of SFAS No. 123, “Accounting
for Stock-Based Compensation” (“SFAS 123,”) as amended by SFAS 148, “Accounting
for Stock-Based Compensation—Transition and Disclosure.” Also in accordance with
the modified prospective transition method, prior interim and annual periods
have not been restated and do not reflect the recognition of stock-based
compensation cost under SFAS 123R. Since the adoption of SFAS 123R, there have
been no changes to the Company’s stock compensation plans or modifications to
outstanding stock-based awards which would increase the value of any awards
outstanding. Compensation expense for all stock-based compensation awards
granted subsequent to January 1, 2006 was based on the grant-date fair value
determined in accordance with the provisions of SFAS 123R.
As
a
result of adopting SFAS 123R, the Company’s net loss and its non-cash
compensation expense as shown in the Consolidated Statements of Operations
for
the three months ended March 31, 2008 and March 31, 2007 is more by $301,870
and
$298,313, respectively, than if the Company had continued to account for
stock-based compensation under Accounting Principles Board Opinion No. 25,
“Accounting for Stock Issued to Employees” (“APB 25”) and its related
interpretations. Basic and diluted net loss per share for the three months
ended
March 31, 2008 and March 31, 2007 is more by $0.004 in both periods than if
the
Company had not adopted SFAS 123R.
5
The
following table indicates where the total stock-based compensation expense
resulting from stock options and awards appears in the Statement of Operations
(unaudited):
Three Months
|
Three Months
|
||||||
Ended
|
Ended
|
||||||
March 31, 2008
|
March 31, 2007
|
||||||
Research
and development
|
$
|
9,183
|
$
|
24,966
|
|||
General
and administrative
|
292,687
|
273,347
|
|||||
|
|||||||
Stock-based
compensation expense
|
$
|
301,870
|
$
|
298,313
|
|||
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 month periods ended March 31, 2008 and March 31, 2007:
Dividend
yield
|
0.00%
|
Risk-free
yields
|
1.35% - 5.02%
|
Expected volatility
|
80% - 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 March 31, 2008,
and related transactions for the three month period then ended (unaudited):
|
|
|
|||||||||||
Weighted Average |
Weighted Average
Remaining |
Total Aggregate |
|||||||||||
Number
of
|
Exercise
|
Contractual
|
Intrinsic
|
||||||||||
Shares
|
Price
|
Life
|
Value
|
||||||||||
Outstanding
at December 31, 2007
|
3,469,841
|
||||||||||||
Granted
|
-
|
$
|
-
|
||||||||||
Exercised
|
(55,000
|
)
|
$
|
0.73
|
|||||||||
Cancelled
|
(5,850
|
)
|
$
|
11.78
|
|||||||||
Outstanding
at March 31, 2008
|
3,408,991
|
$
|
1.40
|
6.94
years
|
$
|
1,410,738
|
|||||||
Vested
or expected to vest at March 31, 2008
|
3,190,475
|
$
|
1.40
|
6.94
years
|
$
|
1,320,310
|
|||||||
Exercisable
at March 31, 2008
|
3,062,590
|
$
|
1.43
|
6.73
years
|
$
|
1,347,537
|
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
|
7.52
years
|
$
|
0.87
|
$
|
1,410,738
|
$
|
2,531,689
|
$
|
0.82
|
$
|
1,347,537
|
||||||||||
2.00
- 3.99
|
139,250
|
2.84
years
|
2.83
|
-
|
139,250
|
2.83
|
-
|
|||||||||||||||
4.00
- 5.50
|
373,651
|
4.26
years
|
4.65
|
-
|
373,651
|
4.65
|
-
|
|||||||||||||||
7.00
- 12.00
|
18,000
|
2.18
years
|
8.67
|
-
|
18,000
|
8.67
|
-
|
|||||||||||||||
3,408,991
|
$
|
1.40
|
$
|
1,410,738
|
$
|
3,062,590
|
$
|
1.43
|
$
|
1,347,537
|
The
weighted-average grant-date fair value of options granted during the three
months ended March 31, 2008 and March 31, 2007 was $0.00 and $0.85,
respectively. The intrinsic value (the difference between the aggregate exercise
price and the closing price of our common stock on the date of exercise) on
the
exercise date of options exercised during the three months ended March 31,
2008
and 2007 was $43,270 and $8,529, respectively. Cash received from option
exercises for the three months ended March 31, 2008 and March 31, 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 quarter ended March
31, 2008, 6,081 shares vested and were issued to each Independent Director.
Although the Board of Directors has approved the full grant of 24,324 shares
to
each Independent Director for the 2008 calendar year, only 6,081 shares have
been issued and the remaining 18,243 shares granted for the remainder of the
2008 calendar year are subject to issuance following shareholder approval of
a
proposed amendment to the Company’s 2006 Stock Incentive Plan.
8
3. LOSS
PER
SHARE
At
March
31, 2008 and 2007, respectively, options to acquire 3,408,991 and 3,372,841
shares of common stock with exercise prices ranging from $.55 to $16.25 per
share and warrants to acquire 12,439,954 and 20,022,527 shares of common stock
with exercise prices ranging from $0.55 to $3.00 were excluded from the
calculation of diluted loss per share, as their effect would be anti-dilutive.
Loss per share for the three months ended March 31, 2008 and 2007 was calculated
as follows (net loss / weighted average common shares outstanding):
FOR THE THREE MONTHS
ENDED MARCH 31,
|
|||||||
2008
|
2007
|
||||||
Net
loss
|
$ |
(1,642,187
|
)
|
$ |
(2,039,309
|
)
|
|
|
|||||||
Weighted
average common shares outstanding used for basic and diluted loss
per share
|
83,094,347
|
80,803,109
|
|||||
Basic
and diluted loss per common share
|
$
|
(0.02
|
)
|
$
|
(0.03
|
)
|
4. NOTE
PAYABLE
October
2007 Note
On
October 26, 2007 the Company issued a note in a principal amount of $3 million.
The note is payable on June 30, 2009 and can be prepaid by the Company at any
time without penalty. Interest accretes on the note on a quarterly basis at
a
rate of 8.0% per annum. The note is 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 will vest if the note remains 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 is being amortized over the 20-month period ending
June 30, 2009.
For
the
three months ended March 31, 2008, the Company recorded $76,883 of amortization
related to the note discount.
9
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.
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 $3
million note referred to above. The Company paid in cash the $2 million balance
on the Note plus accrued interest of $42,028.
For
the
three months ended March 31, 2007, the Company recorded $31,846 of amortization
related to the note discount.
5.
|
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 March 31, 2008, the Company has
accrued $1,045,329 in deferred compensation.
6. INCOME
TAXES
In
consideration of the Company’s accumulated losses and lack of historical ability
to generate taxable income, the Company has determined that it will not be
able
to realize any benefit from its temporary differences between book income and
taxable income in the foreseeable future, and has recorded a valuation allowance
of an equal amount to fully offset the deferred tax benefit
amount.
10
7. COMMITMENTS
AND CONTINGENCIES
The
Company is a party to clinical research agreements in connection with a one-year
open-label study for its topical
alprostadil-based cream treatment for erectile dysfunction (“ED Product”) with
commitments by the Company that initially totaled approximately $12.8 million.
These agreements were amended in October 2005 such that the total commitment
was
reduced to approximately $4.2 million. These agreements provide that if the
Company cancels them prior to 50% completion, the Company will owe the higher
of
10% of the outstanding contract amount prior to the amendment or 10% of the
outstanding amount of the amended contract at the time of cancellation. At
March
31, 2008, such amount is approximately $1.1 million.
8. LICENSING
AGREEMENTS
On
November 1, 2007, the Company signed an exclusive licensing agreement with
Warner Chilcott Company, Inc. (“Warner”) for its topical alprostadil-based cream
treatment for erectile dysfunction (“ED Product”). Under the agreement, Warner
acquired the exclusive rights in the United States to the ED Product and will
assume all further development, manufacturing, and commercialization
responsibilities as well as costs. Warner agreed to pay the Company an up front
payment of $500,000 and up to $12.5 million in milestone payments on the
achievement of specific regulatory milestones. In addition, the Company is
eligible to receive royalties 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 the ED Product. Pursuant to the
agreement, NexMed is responsible for the regulatory approval of the ED Product.
Accordingly, for the three months ended March 31, 2008, the Company recognized
licensing revenue of $166,667 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 is being recognized as revenue on
a
straight-line basis over the 18-month period ending June 30, 2008, which is
the
estimated performance period for Novartis to complete the remaining preclinical
studies. Accordingly, for the three months ended March 31, 2008, the Company
recognized licensing revenue of $282,319 related to the initial cash payment
at
signing.
11
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 is being recognized on a straight-line basis over the estimated
remaining six months to complete the Phase 3 clinical trial. Accordingly, for
the three months ended March 31, 2008, the Company recognized licensing revenue
of $500,000 related to the $1.5 million milestone payment.
9. SUBSEQUENT
EVENTS
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 approximately $420,000 upon the issuance of 471,909 shares
of the Company’s common stock upon the exercise of such warrants.
12
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 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.
13
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.
On
July
9, 2007, we announced
that Novartis had completed patient enrollment for the Phase 3 clinical trials
for NM100060. The
Phase
3 program for NM100060 consists of two pivotal, randomized, double-blind,
placebo-controlled studies. The parallel group studies are designed to assess
the efficacy, safety and tolerability of NM100060 in patients with mild to
moderate toenail onychomycosis. Approximately 1,000 patients are enrolled in
the
two studies, which are taking place in the U.S., Europe, Canada and Iceland.
The
Phase
3 program is expected to be completed in mid-2008, and top line results should
be available to us in early Fall 2008, with Novartis planning to file the New
Drug Application (“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 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.
The
completion of patient enrollment in the ongoing Phase 3 clinical trials for
NM100060 has 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 the third quarter of 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.
14
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 (the “ED
Product”), which was previously known as Alprox-TD®.
Our NDA
was filed and accepted for review by the FDA in September and November 2007,
respectively. As such, according to the Prescription Drug User Fees Act
(“PDUFA”), the FDA’s expected target action date regarding approval of our NDA
is July 19, 2008, assuming the FDA does not require any significant additional
studies or information during the review process.
On
November 1, 2007, we licensed the U.S. rights of our ED Product 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
our ED Product. However, should Warner determine that it does not wish to
continue the regulatory approval process for our ED Product, the licensing
agreement would terminate, and the U.S. rights to the ED Product would revert
back to us.
The
NDA
for our ED Product is based on a formulation that requires refrigeration for
stability. We have developed the prototype for a non-refrigerated ED Product.
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 the ED
Product. Pursuant to the Warner contract, Warner would fund the development
expenses for the room temperature ED Product if Warner and NexMed jointly decide
to switch to the room temperature ED Product for commercialization.
In
terms
of the NDA filing in the U.S., we have taken the regulatory position that the
long term safety data for the ED Product 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 the ED Product. As such, we will learn whether the FDA agrees with
our
position as they are reviewing our NDA. We currently estimate the cost to
complete a 12 month open-label study to be approximately $8 million. Warner
will
undertake the investment necessary to complete the 12 month open-label study
should it be required by the FDA. However, should Warner determine that it
does
not wish to seek further regulatory approval of our ED Product then the
licensing agreement would terminate and all rights would revert back to us.
There is always the risk that we will not be successful in convincing the FDA
to
approve the product for marketing.
15
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 our ED
Product. 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. However, the withhold status does not prevent the
FDA
from reviewing other components of the NDA for approval of our ED product.
We
are responding to their observations in a timely manner in order to ensure
that
our facility is compliant with GMP well in advance of commercial manufacturing.
While Warner intends to manufacture our ED Product 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 our ED Product
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
our
ED Product in Canada. The review and approval process in Canada typically takes
about 12 months. Even though we are encouraged by the initial positive feedback
from Health Canada, the risk remains that we may not be successful in convincing
them to approve our product for marketing.
On
April
20, 2007, the United Kingdom regulatory authority, Medicines and Healthcare
Products Regulatory Agency (the “MHRA”) also informed us that the safety data
that we have compiled to date was sufficient for the MAA to be filed and
accepted for review in the United Kingdom. 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. As a result of the MHRA’s backlog, we are evaluating the
possibility of using another reference state for our filing under the mutual
recognition system to accelerate the filing in Europe. 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.
16
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
development
The
two
patents covering the first generation of the NexACT®
technology enhancer will expire in 2008 and 2009. However, our current products
under development contain the second generation of the NexACT®
technology which is protected by a patent that will expire in
2019.
17
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.
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.
18
Successful
commercialization of our products may depend on the availability of
reimbursement to consumers from third-party healthcare payers, such as
government and private insurance plans. Even if we succeed in bringing one
or
more products to market, reimbursement to consumers may not be available or
sufficient to allow us to realize an appropriate return on our investment in
product development or to sell our products on a competitive basis. In addition,
in certain foreign markets, pricing or profitability of prescription
pharmaceuticals is subject to governmental controls. In the U.S., federal and
state agencies have proposed similar governmental control and the U.S. Congress
has recently considered legislative and regulatory reforms that may affect
companies engaged in the healthcare industry. Pricing constraints on our
products in foreign markets and possibly in the U.S. could adversely affect
our
business and limit our revenue.
Liquidity,
Capital Resources and Financial Condition.
We
have
experienced net losses and negative cash flows from operations each year since
our inception. Through March 31, 2008, we had an accumulated deficit of
$136,160,289. 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
March
31, 2008 we had cash and cash equivalents and short term investments of
approximately $2.4 million as compared to $3.5 million at December 31, 2007.
The
reduction in our cash balance in 2008 was partially 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
8
of the Consolidated Financial Statements. Our net decrease in cash in the first
three 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 $300,000 to support our NDA and NDS filings for our topical ED
Product.
19
Our
cash
reserves of $1.8 million as of the date of this report provide us with
sufficient cash to fund our operations through August 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 into the first quarter 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 in 2008.
We
do not
intend to trigger the approximately $1.2 million in direct expenditures budgeted
for our early stage products under development until we have significantly
improved our cash position.
On
March
5, 2008 we executed a non-binding term sheet with a potential buyer to close
a
sale-leaseback transaction on our East Windsor, New Jersey facility in the
second quarter of 2008 at a purchase price of $7 million. The closing of this
transaction in the second quarter, along with our current cash reserves would
provide sufficient funding for our operations to the end of 2008, and with
the
$3.5 million payment for the patent allowance, through the second quarter of
2009. However, there is no assurance that we can agree on terms and close this
transaction in the second quarter of 2008 or at all.
Before
the end of 2008, we expect significant cash infusions from Novartis assuming
the
Phase 3 trial for NM100060 is successful. We will receive a $6 million 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
March
31, 2008, we had $151,430 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.
To
date,
we have spent approximately $71 million on our ED Product development program.
Pursuant to our license agreement signed on November 1, 2007, Warner will
undertake the manufacturing investment and any other investment for further
product development that may be required for product approval in the United
States. We anticipate that the remaining cost to prepare all of the relevant
dossiers and assemble the regulatory approval applications in 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.
20
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 March 31, 2008 and
2007.
Revenue,
principally license fee revenue.
We
recorded $951,787 in revenue during the first quarter of 2008, as compared
to
$286,959 in revenue during the first quarter of 2007. The increase in revenue
is
primarily due to the $500,000 in revenue recognized related to the $1.5 million
milestone payment received from Novartis on March 4, 2008 as discussed in Note
8
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 8 of the Consolidated Financial Statements.
Research
and Development Expenses.
Our
research and development expenses for the first quarter of 2008 and 2007 were
$1,169,091 and $1,077,883, respectively. Research and development expenses
in
the first quarter of 2008 included approximately $429,000 attributable to our
ED
Product and the balance attributable to other NexACT®
technology based products and indirect overhead related to research and
development, as compared to approximately $335,000 for our ED
Product during
the same period in 2007.
General
and Administrative Expenses.
Our
general and administrative expenses were $1,303,398 during the first quarter
of
2008 as compared to $1,232,895 during the same period in 2007. The slight
increase is primarily due to an increase of approximately $100,000 in legal
fees
related to the national filings of patent applications for our ED Product as
well as legal fees in connection with a patent lawsuit in which we are the
plaintiff suing for patent infringement of our herpes treatment medical device.
There was also an increase in salaries of approximately $50,000 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 $78,000 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
interest expense net of interest income of $121,485 during the first quarter
of
2008, as compared to $15,490 during the same period in 2007. The increase is
primarily due to the $3 million mortgage note executed in October 2007 as
discussed in Note 4 of the Consolidated Financial Statements whereby we
amortized $76,883 of the note discount in 2008. Additionally, we recorded more
interest income in 2007 because our cash balance at March 31, 2007 was higher
than at March 31, 2008.
21
Net
Loss.
The net
loss was $1,642,187 or $0.02 per share and $2,039,309 or $0.03 per share in
the
first quarter of 2008 and 2007, respectively. The decrease is primarily
attributable to the increase in revenue as a result of the $500,000 in revenue
recognized as a result of the milestone payment received from Novartis during
the 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 8
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.
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.
22
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.
ITEM 2. |
UNREGISTERED
SALES OF EQUITY SECURITIES AND USE OF
PROCEEDS
|
None.
23
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.
|
24
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:
May 8, 2008
|
/s/
Mark Westgate
|
Vice
President and Chief Financial
Officer
|
25
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.
|
26