SEELOS THERAPEUTICS, INC. - Quarter Report: 2007 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,
2007.
|
Commission
file number 0-22245
NEXMED,
INC.
(Exact
Name of Issuer as Specified in Its Charter)
Nevada
|
87-0449967
|
(State
or Other Jurisdiction of
|
(I.R.S.
Employer
|
Incorporation
or Organization)
|
Identification
No.)
|
89
Twin Rivers Drive, East Windsor, NJ 08520
(Address
of Principal Executive Offices)
(609)
371-8123
(Issuer’s
Telephone Number, Including Area Code)
Indicate
by check mark whether the registrant: (1) has filed all reports required to
be
filed by Section 13 or 15 (d) of the Exchange Act during the preceding 12 months
(or for such shorter period that the registrant was required to file such
reports), and (2) has been subject to such filing requirements for the past
90
days.
Yes
x No
o
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, or a non-accelerated filer. See definition of “accelerated
filer and large accelerated filer” in Rule 12b-2 of the Exchange Act. (Check
one):
Large
accelerated filer o
|
Accelerated
filer o
|
Non-accelerated
filer x
|
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act). Yes o No
x
Indicate
the number of shares outstanding of each of the issuer’s classes of common
equity, as of the latest practicable date: as of May
8,
2007, 81,067,352 shares of Common Stock, par value $0.001 per share, were
outstanding.
Table
of
Contents
Page
|
||||
Part
I. FINANCIAL INFORMATION
|
||||
Item
1.
|
Financial
Statements
|
|||
Unaudited
Consolidated Balance Sheets at March 31, 2007 and December 31,
2006
|
1
|
|||
Unaudited
Consolidated Statements of Operations for the Three Months Ended
March
|
||||
31,
2007 and March 31, 2006
|
2
|
|||
Unaudited
Consolidated Statements of Cash Flows for the Three Months Ended
March
|
||||
31,
2007 and March 31, 2006
|
3
|
|||
Notes
to Unaudited Consolidated Financial Statements
|
4
|
|||
Item
2.
|
Management's
Discussion and Analysis of Financial Condition and Results
of
|
|||
Operations
|
14
|
|||
Item
3.
|
Qualitative
and Quantitative Disclosures about Market Risk
|
22
|
||
Item
4.
|
Controls
and Procedures
|
22
|
||
Part
II. OTHER INFORMATION
|
||||
Item
1.
|
Legal
Proceedings
|
23
|
||
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 (Unaudited)
March
31,
|
December
31,
|
||||||
2007
|
2006
|
||||||
(Unaudited)
|
|||||||
Assets
|
|||||||
Current
assets:
|
|||||||
Cash
and cash equivalents
|
$
|
8,163,420
|
$
|
11,069,133
|
|||
Short
term investments
|
2,500,000
|
1,000,000
|
|||||
Other
receivable
|
-
|
183,700
|
|||||
Debt
issuance cost, net of accumulated amortization
|
|||||||
of
$45,357 and $36,752
|
19,198
|
27,803
|
|||||
Prepaid
expenses and other assets
|
195,925
|
164,898
|
|||||
Total
current assets
|
10,878,543
|
12,445,534
|
|||||
Fixed
assets, net
|
7,316,303
|
7,488,100
|
|||||
Total
assets
|
$
|
18,194,846
|
$
|
19,933,634
|
|||
Liabilities
and stockholders' equity
|
|||||||
Current
liabilities:
|
|||||||
Accounts
payable and accrued expenses
|
$
|
693,613
|
$
|
587,750
|
|||
Payroll
related liabilities
|
122,725
|
156,567
|
|||||
Deferred
revenue
|
1,411,598
|
1,693,917
|
|||||
Deferred
compensation - current portion
|
60,930
|
60,212
|
|||||
Convertible
notes payable - current portion
|
3,000,000
|
3,000,000
|
|||||
Note
payable, net of debt discount of $95,538 and $127,385
|
1,904,462
|
1,872,615
|
|||||
Total
current liabilities
|
7,193,328
|
7,371,061
|
|||||
Long
Term liabilities:
|
|||||||
Deferred
compensation
|
1,016,682
|
1,058,098
|
|||||
Total
Liabilities
|
8,210,010
|
8,429,159
|
|||||
Commitments
and contingencies (Note 9)
|
|||||||
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, 80,965,829 and 80,285,905 issued
|
|||||||
and
outstanding, respectively
|
80,968
|
80,287
|
|||||
Additional
paid-in capital
|
137,683,647
|
137,164,658
|
|||||
Accumulated
other comprehensive loss
|
(9,596
|
)
|
(9,596
|
)
|
|||
Accumulated
deficit
|
(127,770,183
|
)
|
(125,730,874
|
)
|
|||
Total
stockholders' equity
|
9,984,836
|
11,504,475
|
|||||
Total
liabilities and stockholders' equity
|
$
|
18,194,846
|
$
|
19,933,634
|
See
notes
to consolidated financial statements.
1
NexMed,
Inc.
Consolidated
Statements of Operations (Unaudited)
FOR
THE THREE MONTHS ENDED
|
|||||||
MARCH
31,
|
|||||||
2007
|
2006
|
||||||
Royalties
and research and development fees
|
$
|
286,959
|
$
|
453,947
|
|||
Operating
expenses
|
|||||||
General
and administrative
|
1,232,895
|
1,832,171
|
|||||
Research
and development
|
1,077,883
|
1,507,975
|
|||||
Total
operating expenses
|
2,310,778
|
3,340,146
|
|||||
Loss
from operations
|
(2,023,819
|
)
|
(2,886,199
|
)
|
|||
Other
expense
|
|||||||
Interest
expense, net
|
(15,490
|
)
|
(20,094
|
)
|
|||
Total
other expense
|
(15,490
|
)
|
(20,094
|
)
|
|||
Net
loss
|
(2,039,309
|
)
|
(2,906,293
|
)
|
|||
Deemed
dividend to preferred shareholders
|
|||||||
from
beneficial conversion feature
|
-
|
(41,704
|
)
|
||||
Preferred
dividend
|
-
|
(12,945
|
)
|
||||
Net
loss applicable to common stock
|
(2,039,309
|
)
|
(2,960,942
|
)
|
|||
Other
comprehensive income
|
|||||||
Foreign
currency translation adjustments
|
-
|
3
|
|||||
Comprehensive
Loss
|
($2,039,309
|
)
|
($2,906,290
|
)
|
|||
Basic
and diluted loss per share
|
$
|
(0.03
|
)
|
$
|
(0.05
|
)
|
|
Weighted
average common shares outstanding
|
|||||||
used
for basic and diluted loss per share
|
80,803,109
|
62,812,481
|
See
notes
to consolidated financial statements.
2
NexMed,
Inc.
Consolidated
Statements of Cash Flows (Unaudited)
FOR
THE THREE MONTHS ENDED
|
|||||||
MARCH
31,
|
|||||||
2007
|
2006
|
||||||
Cash
flows from operating activities
|
|||||||
Net
loss
|
$
|
(2,039,309
|
)
|
$
|
(2,906,293
|
)
|
|
Adjustments
to reconcile net loss to net cash used in operating
|
|||||||
activities
|
|||||||
Depreciation
and amortization
|
171,798
|
234,082
|
|||||
Non-cash
interest, amortization of debt discount and
|
|||||||
deferred
financing costs
|
68,229
|
2,836
|
|||||
Non-cash
compensation expense
|
358,313
|
414,662
|
|||||
Loss
on disposal of fixed assets
|
-
|
186,381
|
|||||
Decrease
in other receivable
|
183,700
|
378,667
|
|||||
Increase
in prepaid expenses and other assets
|
(31,027
|
)
|
(5,615
|
)
|
|||
Decrease
in deferred revenue
|
(282,319
|
)
|
(247,971
|
)
|
|||
Decrease
in payroll related liabilities
|
(33,842
|
)
|
(852,590
|
)
|
|||
Decrease
in deferred compensation
|
(40,698
|
)
|
-
|
||||
Increase/(decrease)
in accounts payable
|
|||||||
and
accrued expenses
|
105,863
|
57,582
|
|||||
Net
cash used in operating activities
|
(1,539,292
|
)
|
(2,738,259
|
)
|
|||
Cash
flow from investing activities
|
|||||||
Capital
expenditures
|
-
|
(54,068
|
)
|
||||
Proceeds
from sale of fixed assets
|
-
|
89,574
|
|||||
Purchase
of short term investments
|
(3,000,000
|
)
|
(6,000,000
|
)
|
|||
Proceeds
from sale of short term investments
|
1,500,000
|
3,500,000
|
|||||
Net
cash used in investing activities
|
(1,500,000
|
)
|
(2,464,494
|
)
|
|||
Cash
flow from financing activities
|
|||||||
Issuance
of common stock, net of offering costs
|
(2,110
|
)
|
7,747,808
|
||||
Proceeds
from exercise of stock options and warrants
|
135,689
|
81,340
|
|||||
Repayment
of capital lease obligations
|
-
|
(104,395
|
)
|
||||
Net
cash provided by financing activities
|
133,579
|
7,724,753
|
|||||
Net
increase (decrease) in cash and cash equivalents
|
(2,905,713
|
)
|
2,522,000
|
||||
Effect
of foreign exchange on cash and cash equivalents
|
-
|
3
|
|||||
Cash
and cash equivalents, beginning of period
|
11,069,133
|
2,953,781
|
|||||
Cash
and cash equivalents, end of period
|
$
|
8,163,420
|
$
|
5,475,784
|
|||
|
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, 2007 are not necessarily indicative of
the
results that may be expected for the year ended December 31, 2007. These
financial statements should be read in conjunction with the financial statements
and notes thereto contained in NexMed, Inc.’s (the “Company”) Annual Report on
Form 10-K for the year ended December 31, 2006.
The
Company has an accumulated deficit of $127,770,183 at March 31, 2007 and the
Company expects to incur additional losses during the remainder of 2007. As
a
result of our losses to date and accumulated deficit, there is doubt as to
our
ability to continue as a going concern, and, accordingly, our independent
registered public accounting firm has modified its report on our December 31,
2006 consolidated financial statements included in our Annual Report on Form
10-K in the form of an explanatory paragraph describing the events that have
given rise to this uncertainty. Management plans to obtain additional financing
through additional partnering agreements for its products under development
using the NexACT®
technology. If the Company is successful in entering into such additional
partnering agreements, it anticipates that it may receive milestone payments,
which would offset some of its research and development expenses. Although
management continues to pursue these plans, there is no assurance that the
Company will be successful in obtaining financing on terms acceptable to it.
If
additional financing cannot be obtained on reasonable terms, future operations
will need to be scaled back or discontinued. These financial statements do
not
include any adjustments that might result from the outcome of this
uncertainty.
In
June
2006, the FASB issued FASB Interpretation No. ("FIN") 48 "Accounting for
Uncertainty in Income Taxes" ("FIN48"). FIN 48 sets forth a recognition
threshold and measurement attribute for financial statement recognition of
positions taken or expected to be taken in income tax returns. The required
adoption of FIN 48 as of January 1, 2007 had no material impact on the Company's
consolidated financial statements.
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 between $0.55 to $16.25. The
maximum term under these plans is 10 years.
4
The
following table summarizes information about options outstanding at March 31,
2007 (unaudited):
|
Options
Outstanding
|
Options
Exercisable
|
|||||||||||||||||||||||
Range
of
Exercise Prices |
Number
Outstanding
|
Weighted
Average Remaining Contractual Life
|
Weighted
Average Exercise Price
|
Aggregate
Intrinsic Value
|
Number
Exercisable
|
Weighted
Average Exercise Price
|
Aggregate
Intrinsic Value
|
||||||||||||||||||
$
|
.55
- 1.85
|
2,824,390
|
8.33
years
|
$
|
0.85
|
$
|
885,853
|
1,940,067
|
$
|
0.84
|
$
|
607,910
|
|||||||||||||
2.00
- 3.99
|
143,750
|
3.87
years
|
2.83
|
-
|
143,750
|
2.83
|
-
|
||||||||||||||||||
|
4.00
- 5.50
|
375,301
|
5.26
years
|
4.65
|
-
|
355,301
|
4.63
|
-
|
|||||||||||||||||
|
7.00
- 8.00
|
15,000
|
3.14
years
|
8.00
|
-
|
15,000
|
8.00
|
-
|
|||||||||||||||||
|
12.00
- 16.25
|
14,400
|
3.47
years
|
13.15
|
-
|
14,400
|
13.15
|
-
|
|||||||||||||||||
3,372,841
|
$
|
1.44
|
$
|
885,853
|
2,468,518
|
$
|
1.61
|
$
|
607,910
|
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,
2007 and March 31, 2006 includes expense for all equity awards granted during
the three months ended 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.
5
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, 2007 and March 31, 2006 is $298,313 and
$378,662 more, 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, 2007 and March 31, 2006 is $0.004 and $0.01 more, respectively, than
if the Company had not adopted SFAS 123R.
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, 2007
|
March
31, 2006
|
||||||
General
and administrative
|
$
|
273,347
|
$
|
374,519
|
|||
Research
and development
|
24,966
|
4,143
|
|||||
Stock-based
compensation expense
|
298,313
|
378,662
|
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 in
deferred expenses in stockholders' equity using the fair value method and then
amortized to expense over the applicable service periods. As a result, the
non-cash charge to operations for non-employee options with vesting or other
performance criteria is valued each reporting period based upon changes in
the
fair value of the Company's common stock.
During
the three months ended March 31, 2007, the Company issued 60,000 shares of
its
common stock in payment for services rendered by a consultant. Accordingly,
the
Company recorded $60,000 to general and administrative expenses in the Statement
of Operations based on the fair value of its common stock on the date of
issuance.
The
fair
value of each stock option grant is estimated on the grant date using the
Black-Scholes option-pricing model with the following assumptions used for
the
three months ended March 31, 2007 and 2006:
6
Dividend
yield
|
0.00
|
%
|
||
Risk-free
interest rate
|
4.15%
- 4.47
|
%
|
||
Expected
volatility
|
80%
- 105
|
%
|
||
Expected
term
|
6
years
|
Expected
Volatility.
The
Company uses analysis of historical volatility to compute the expected
volatility of its stock options.
Expected
Term. The
expected term is based on several factors including historical observations
of
employee exercise patterns during the Company’s history and expectations of
employee exercise behavior in the future giving consideration to the contractual
terms of the stock-based awards.
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, 2007,
and related transactions for the three months then ended (unaudited):
7
|
|
Weighted
|
|
Weighted
Average
|
|
Total
|
|
||||||
|
|
|
|
Average
|
|
Remaining
|
|
Aggregate
|
|
||||
|
|
Number
of
|
|
Exercise
|
|
Contractual
|
|
Intrinsic
|
|
||||
|
|
Shares
|
|
Price
|
|
Life
|
|
Value
|
|||||
Outstanding
at December 31, 2006
|
3,613,421
|
||||||||||||
Granted
|
12,100
|
$
|
0.85
|
||||||||||
Exercised
|
(28,480
|
)
|
$
|
0.55
|
|||||||||
Cancelled
|
(224,200
|
)
|
$
|
2.91
|
|||||||||
Outstanding
at March 31, 2007
|
3,372,841
|
$
|
1.44
|
7.76
years
|
$
|
885,853
|
|||||||
Vested
or expected to vest at
|
|||||||||||||
March
31, 2007
|
3,156,642
|
$
|
1.44
|
7.76
years
|
$
|
885,853
|
|||||||
Exercisable
at March 31, 2007
|
2,468,518
|
$
|
1.61
|
7.43
years
|
$
|
607,910
|
The
weighted-average grant-date fair value of options granted during the three
months ended March 31, 2007 and March 31, 2006 was $0.85 and $0.78,
respectively. The intrinsic value of options exercised during the three months
ended March 31, 2007 and 2006 was $8,529 and $99,400, respectively. Cash
received from option exercises for the three months ended March 31, 2007 and
March 31, 2006, was $15,664 and $81,340, respectively.
On
January 24, 2007, the Company issued awards of restricted shares of the
Company’s common stock to Richard Berman, Chief Executive Officer, Vivian Liu,
Chief Operating Officer, and Mark Westgate, Chief Financial Officer. Mr.
Berman’s award of 60,000 shares vests in four equal installments on March 31,
June 30, September 30, and December 31, 2007, assuming continuous and
uninterrupted service as Chief Executive Officer of the Company. Ms. Liu and
Mr.
Westgate received awards of 150,000 and 75,000 shares, respectively. Ms. Liu's
and Mr. Westgate’s awards vest in three
equal installments on December 31, 2007, 2008 and 2009, assuming continuous
and
uninterrupted service with the Company.
Also
on
January 24, 2007, the Company issued awards of shares of the Company’s common
stock to Board members Leonard Oppenheim, Martin Wade and Arthur Emil for their
services. Mr. Oppenheim received an award of 25,000 shares for his service
as
Chairman of the Board of Directors. Mr. Wade received an award of 10,000 shares
for his service as Chairman of the Audit Committee and Compensation Committee
of
the Board of Directors. Mr. Emil received an award of 5,000 shares for his
service as Chairman of the Corporate Governance/Nominating Committee of the
Board of Directors.
The
Company appointed Dr. David S. Tierney to the Board of Directors on January
24,
2007. In connection with his appointment to the Board, the Company issued an
award of restricted shares of the Company’s common stock as
compensation for his services as a member of the Board of Directors. The
restricted stock award of 30,000 shares vests in three equal installments on
February 1, 2007 and on the dates of the Annual Meeting of Stockholders in
2007
and 2008, assuming continuous and uninterrupted service with the Company.
8
As
of
March 31, 2007, there was $493,593 of total unrecognized compensation cost
related to non-vested stock and stock options. That cost is expected to be
recognized over a weighted-average period of 1.47 years.
3. LOSS
PER
SHARE
At
March
31, 2007 and 2006, respectively, options to acquire 3,372,841 and 3,077,595
shares of common stock with exercise prices ranging from $0.55 to $16.25 per
share, convertible securities convertible into 600,000 and 1,200,000 shares
of
common stock at a conversion price of $5.00, and warrants to acquire 20,022,527
and 14,769,426 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. Earnings per share for the three months ended
March 31, 2007 and 2006 was calculated as follows (net loss applicable to common
stock / weighted average common shares outstanding):
FOR
THE THREE MONTHS
|
|||||||
ENDED
MARCH 31,
|
|||||||
2007
|
2006
|
||||||
Net
loss applicable to common stock
|
($2,039,309
|
)
|
($2,960,942
|
)
|
|||
Weighted
average common shares outstanding
|
|||||||
used
for basic and diluted loss per share
|
80,803,109
|
62,812,481
|
|||||
Basic
and diluted loss per common share
|
$
|
(0.03
|
)
|
$
|
(0.05
|
)
|
4. CONVERTIBLE
NOTES PAYABLE
On
December 12, 2003, the Company issued convertible notes (the “Notes”) in an
aggregate principal amount of $6 million. The Notes are payable in two
installments of $3 million on November 30, 2006 and May 31, 2007 and are
collateralized by the Company’s facility in East Windsor, New Jersey which has a
carrying value of approximately $6.9 million. The Notes were initially
convertible into shares of the Company’s common stock at a conversion price
equal to $6.50 per share (923,077 shares). Pursuant to the terms of the Notes,
the conversion price was adjusted on June 14, 2004 to the greater of (i) the
volume weighted average price of the Company’s stock over the six-month period
ending on such date and (ii) $5.00. Since the volume weighted average price
of
the Company’s stock during this period was below $5.00, the conversion price was
adjusted to $5.00 (1,200,000 shares). Interest accretes on the Notes on a
semi-annual basis at a rate of 5% per annum, and the Company may pay such
amounts in cash or by effecting the automatic conversion of such
amount
into the
Company’s common stock at a 5% premium to the then average market prices.
9
On
November 30, 2006, the Company paid in cash the $3 million installment due
plus
accrued interest of $25,417. The remaining $3 million balance plus accrued
interest on the Note is payable on May 31, 2007.
In
April
2007, the Company issued 59,576 shares of its common stock as payment of an
aggregate of $75,833 in interest on the Notes.
5. NOTE
PAYABLE
On
November 30, 2006, the Company issued a Note in principal amount of $2 million.
The Note is 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 accretes on the Note on a quarterly basis at a rate of 7.5% per annum
provided, however, if the Company has not entered into a contract of sale of
the
East Windsor property on or prior to May 31, 2007, and the Note has not been
repaid by such date, the interest rate will increase to 8.5%.
The
Company also issued the Note holder a 4-year detachable warrant to purchase
500,000 shares of common stock at an exercise price of $0.5535. The Company
valued the warrants using the Black-Scholes pricing model. The Company allocated
a relative fair value of $138,000 to the warrants. The relative fair value
of
the warrants is allocated to additional paid in capital and treated as a
discount to the Note that is being amortized over the 13-month period ending
December 31, 2007.
On
February 28, 2007, the Company issued 28,809 shares of its common stock as
payment of an aggregate of $25,000 in interest on the Note
6. DEFERRED
COMPENSATION
On
February 27, 2002, the Company entered into an employment agreement with Y.
Joseph Mo, Ph.D., that has 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 is 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 commence subject to certain limitations, including annual vesting
through January 1, 2007, as set forth in the employment agreement. The deferred
compensation will be payable monthly for 180 months commencing on termination
of
employment. Dr. Mo’s employment was terminated as of December 15, 2005. The
monthly deferred compensation payment through May 15, 2021 will be $9,158.
The
first payment of $64,106 was made on June 30, 2006 representing the first seven
months of payments due under the agreement. As of March 31, 2007 the Company
has
accrued $1,077,612, which is included in deferred compensation, based upon
the
estimated present value of the obligation.
7. SERIES
C
6% CUMULATIVE CONVERTIBLE PREFERRED STOCK
On
May
17, 2005, the Company sold an aggregate of 445 shares of its Series C 6%
cumulative convertible preferred stock (the “Series C Stock”) and raised gross
proceeds of $4,450,000 ($10,000 liquidation preference per share). Each
preferred share of the Series C Stock was initially convertible at the holder’s
option into approximately 7,353 shares of common stock (total of 3,272,059
shares). Each investor also received for each share of Series C Stock purchased,
4-year detachable warrants to purchase 2,672 shares of common stock (total
of
1,188,931 warrants) at an exercise price of $1.43 per share. The Series C Stock
could be converted at any time, at the holder’s option, into shares of the
Company’s common stock at an initial conversion value of $1.36. The Company also
had the right to force conversion of the Series C Stock, under certain
circumstances, at the initial conversion value. Under the terms of the
certificate of designation of the Series C Stock, the Company agreed to redeem
at the liquidation preference per share or convert the Series C Stock on a
quarterly basis, subject, in each case to reduction by previously converted
shares of Series C Stock, as follows: $2 million plus accrued dividends on
September 30, 2005, $1 million plus accrued dividends each on December 31,
2005
and September 30, 2006 and $450,000 plus accrued dividends on September 30,
2006. As a result of the conversions described below, no shares of the Series
C
Stock remained outstanding as of March 31, 2007.
10
The
Company valued the warrants using the Black-Scholes pricing model. The Company
allocated a relative fair value of $799,844 to the warrants. The relative fair
value of the warrants was allocated to additional paid in capital and treated
as
a discount to the Series C Stock that would not be amortized until such time
as
the redemption for cash became probable. Therefore, the Company
recorded a deemed dividend to the shareholders of the Series C Stock in
proportion to the amount redeemed at any time redemption for cash became
probable. Assumptions utilized in the Black-Scholes model to value the warrants
were: exercise price of $1.43 per share; fair value of the Company’s common
stock on the date of issuance of $1.33 per share; volatility of 80%; term of
4
years and a risk-free interest rate of 3.97%.
The
allocated value of the Series C Stock contained a beneficial conversion feature
calculated based upon the difference between the effective conversion price
of
the proceeds allocated to the Series C Stock, and the fair market value of
the
common stock on the date of issuance. As a result, the Company recorded a deemed
dividend to the shareholders of the Series C Stock of $636,241 on the issuance
date, representing the value of the beneficial conversion feature of the Series
C Stock. As the Company had no retained earnings on the date of the deemed
dividend, the dividend was recorded as a reduction to additional paid in
capital.
The
Company also recorded a discount to the Series C Stock of $209,686 based on
a
contingent beneficial conversion feature which would arise because the Company
must adjust the conversion price to be equal to a 4.5% discount to the then
common stock price on each respective settlement date. The Company has amortized
this discount, which is treated as a deemed dividend, over the life of the
Series C Stock using the effective interest method. For the three months ended
March 31, 2007 and 2006, the Company recorded a deemed dividend to the
shareholders of the Series C Stock of $0 and $11,175, respectively, based on
the
amortization of the beneficial conversion feature.
For
the
three months ended March 31, 2007 and 2006 pursuant to the terms of the Series
C
Stock, the Company recorded dividends in the amount of $0 and $12,945,
respectively, as a dividend to preferred shareholders in the Consolidated
Statements of Operations.
11
On
June
30, 2006, pursuant to the terms of the Series C Stock, the Company converted
the
remaining 15.5 preferred shares and accrued dividends through June 30, 2006
of
$159,612 at a price of $0.65 per share. Upon conversion, the Company issued
a
total of 244,113 shares of common stock. As of March 31, 2007, no shares of
the
Series C Stock remained outstanding.
The
Company incurred issuance costs associated with the preferred placement of
$230,031. The relative fair value of the issuance costs attributable to the
Series C Stock of $188,685 was accreted as a deemed dividend to the holders
of
the Series C Stock at such time conversion became probable. The relative fair
value of the issuance costs attributable to the warrants of $41,346 has been
recorded as an offset to additional paid in capital. For the three months ended
March 31, 2007 and 2006, the Company amortized $0 and $30,529, respectively
of
the issuance costs as a deemed dividend to the preferred shareholders in the
Consolidated Statements of Operations.
8. INCOME
TAXES
In
consideration of the Company’s accumulated losses and lack of historical ability
to generate taxable income, the Company has estimated that it will not be able
to realize any benefit from its temporary differences between book income and
taxable income and has recorded a valuation allowance of an equal amount to
fully offset the deferred tax benefit amount.
9. COMMITMENTS
AND CONTINGENCIES
The
Company is a party to clinical research agreements in connection with a one-year
open-label study for Alprox-TD®
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, 2007, this amounts to approximately $1.1 million. The Company anticipates
that the clinical research in connection with the agreements will be completed
in 2007.
10. LICENSING
AGREEMENTS
On
September 15, 2005, the Company signed an exclusive global licensing agreement
with Novartis International Pharmaceutical Ltd., (“Novartis”) for its
anti-fungal product, NM100060. Under the agreement, Novartis acquired the
exclusive worldwide rights to NM100060 and would assume all further development,
regulatory, manufacturing and commercialization responsibilities as well as
costs. Novartis agreed to pay the Company up to $51 million in upfront and
milestone payments on the achievement of specific development and regulatory
milestones, including an initial cash payment of $4 million at signing. In
addition, the Company is eligible to receive royalties based upon the level
of
sales achieved and is entitled to receive reimbursements of third party
preclinical study costs up to $3.25 million. The Company is recognizing the
initial up front and preclinical reimbursement revenue from this agreement
based
on the cost-to-cost method over the 32-month period estimated to complete the
remaining preclinical studies for NM100060.
12
On
February 16, 2007, the Novartis agreement was amended. Pursuant to the
amendment, the Company is no longer obligated to complete the remaining
preclinical studies for NM100060. Novartis has taken over all responsibilities
related to the remaining preclinical studies. As such, the balance of deferred
revenue of $1,693,917 at December 31, 2006 is being recognized as revenue on
a
straight line basis over the 18 month period ended June 30, 2008 which is the
estimated performance period for Novartis to complete the remaining preclinical
studies. Accordingly, for the three month period ended March 31, 2007, the
Company recognized licensing revenue of $282,319 related to the Novartis
agreement.
11. RESTRUCTURING
On
December 15, 2005, the Company announced the departure of Dr. Y. Joseph Mo
as
President and Chief Executive Officer of the Company. On January 12, 2006,
the
Company announced the appointment of Richard J. Berman, who has served on the
Board of Directors since 2002, as Chief Executive Officer of the Company. The
Board of Directors mandated Mr. Berman to improve the Company’s financial
condition and focus its development efforts.
The
Company has incurred and expensed $0 and $178,459 in the first quarter of 2007
and 2006, respectively, in connection with a reduction in staff initiated during
the first quarter of 2006 related to this restructuring. $171,993 of these
costs
are included in research and development expenses in the Consolidated Statement
of Operations for the three months ended March 31, 2006.
The
Company paid out $116,834 in the first quarter of 2006 that was accrued in
2005
related to staff reductions in 2005.
There
were no payments made during the first quarter of 2007 related to restructuring.
In
addition, the Company paid out $902,239 in the first quarter of 2006 that was
accrued and expensed in 2005 related to the departure of Dr. Mo and Kenneth
Anderson in December 2005.
13
ITEM
2. MANAGEMENT'S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
OPERATIONS
Disclosures
Regarding Forward-Looking Statements.
The
following should be read in conjunction with the unaudited consolidated
financial statements and the related notes that appear elsewhere in this
document. This report includes forward-looking statements made based on current
management expectations pursuant to the safe harbor provisions of the Private
Securities Litigation Reform Act of 1995. These statements are not guarantees
of
future performance and actual outcomes may differ materially from what is
expressed or forecast. There are many factors that affect our business,
consolidated financial position, results of operations and cash flows, including
but not limited to, our ability to enter into partnering agreements or raise
financing on acceptable terms, successful completion of clinical development
programs, regulatory review and approval, product development and acceptance,
manufacturing, competition, and/or other factors, many of which are outside
our
control.
General.
We
are a
Nevada corporation and have been in existence since 1987. Since 1994, we have
positioned ourselves as a pharmaceutical and medical technology company with
a
focus on developing and commercializing therapeutic products based on
proprietary delivery systems. We are currently focusing our efforts on new
and
patented topical pharmaceutical products based on a penetration enhancement
drug
delivery technology known as NexACT®,
which
may enable an active drug to be better absorbed through the skin.
The
NexACT®
transdermal drug delivery technology is designed to enhance the absorption
of an
active drug through the skin, overcoming the skin's natural barrier properties
and enabling high concentrations of the active drug to rapidly penetrate the
desired site of the skin or extremity. Successful application of the
NexACT®
technology would improve therapeutic outcomes and reduce systemic side effects
that often accompany oral and injectable medications. We 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.
We
have
applied the NexACT®
technology to a variety of compatible drug compounds and delivery systems,
and
are in various stages of developing new topical treatments for sexual
dysfunction and nail fungus.
On
September 15, 2005, we announced an exclusive global licensing agreement with
Novartis International Pharmaceutical Ltd. (“Novartis”), for NM100060, our
proprietary nail lacquer treatment for onychomycosis (nail fungal infection).
Under the agreement, Novartis acquired the exclusive worldwide rights to
NM100060 and has assumed all further development, regulatory, manufacturing
and
commercialization responsibilities as well as costs. Novartis agreed to pay
us
up to $51 million in upfront and milestone payments on the achievement of
specific development and regulatory milestones, including an initial cash
payment of $4 million at signing. In addition, we are eligible to receive
royalties based upon the level of sales achieved. On January 31, 2007, we
announced
that Novartis, had commenced dosing of patients in 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 will participate
in
the two studies, which will take place in the U.S., Europe, Canada and Iceland.
The Phase 3 program is expected to be competed in mid-2008.
14
In
March
2007, Novartis commenced a comparator study in ten European countries. Over
900
patients with mild to moderate onychomycosis will participate in this open-label
study, which is designed to assess the safety and tolerability of NM100060
(terbinafine 10% topical formulation) versus amorolfine 5% nail lacquer, a
topical treatment for onychomycosis that is approved in Europe.
The
most
advanced of our products under development is Alprox-TD®
which
is
an alprostadil-based cream treatment intended for patients with erectile
dysfunction. In December 2002, we completed our two pivotal Phase 3 studies
for
Alprox-TD®
that
tested over 1,700 patients at 85 sites throughout the U.S. We announced in
2006
that we have developed a room temperature stable Alprox-TD®.
We
believe the opportunity to distribute a non-refrigerated alprostadil product
will be attractive for potential licensing partners. However, even if we attract
a potential partner, consummation of a commercialization arrangement is subject
to complex negotiations of contractual relationships, and we may not be able
to
consummate such relationship on a timely basis, or on terms acceptable to us.
We
are
pursuing a new regulatory strategy for Alprox-TD®
which
includes the filing of the New Drug Application (“NDA”) in the United States,
New Drug Submission in Canada, and Marketing Authorization Application (“MAA”)
in Europe during first half of 2007. With input from independent regulatory
consultants and legal counsel, we believe the safety data of
Alprox-TD® based on our clinical database of over 3,000 patients is
sufficient for filing the NDA and, therefore, we do not need to conduct
a12-month open-label study indicated by ICH (International Conference on
Harmonisation of Technical Requirements for Registration of Pharmaceuticals
for
Human Use) guidance. We believe our strategy is aggressive but has a reasonable
likelihood of success, and we anticipate that the cost to prepare all of the
relevant dossiers and assemble the regulatory approval applications in the
U.S.,
Canada and Europe will be approximately $1.9 million. However, we cannot be
certain that our applications with the appropriate regulatory authorities will
be accepted for filing, and it is also possible that even if our applications
have been accepted, we may not be successful in convincing the regulatory
authorities to accept our position.
On
February 21, 2007, the Canadian regulatory authority, Health Canada, informed
us
that the safety data on Alprox-TD® that we have compiled to date is
sufficient for the New Drug Submission application (“NDS”) to be filed and
accepted for review in Canada. As such, the lack of a completed 12-month open
label safety study will not preclude Health Canada from accepting and reviewing
our NDS in Canada.
15
Further,
on April 20, 2007, the United Kingdom regulatory authority, Medicines and
Healthcare products Regulatory Agency (“MHRA”), also informed us that the safety
data on Alprox-TD® that we have compiled to date is sufficient for
the MAA to be filed and accepted for review in the United Kingdom. As such,
the
lack of a completed 12-month open label safety study will not preclude MHRA
from
accepting and reviewing our MAA in the United Kingdom.
Alprox-TD®
has been
selling in China and in Hong Kong since October 2001 and April 2002,
respectively, under the Befar trademark. The product is manufactured and
marketed by a local affiliate of Vergemont International Limited, our Asian
licensee. We are entitled to receive from our Asian licensee very modest royalty
payments in connection with the distribution of Befar®
in China
and other Asian markets if and when Befar®
is
approved for marketing in such other markets. The sale of Befar®
has been
limited for several reasons including that China has a limited number of
patients who can afford erectile dysfunction treatments.
We
are
also developing Femprox®,
which
is an alprostadil-based cream product intended for the treatment of female
sexual arousal disorder. We have completed one U.S. Phase 2 study for
Femprox®,
and
also a 400-patient study for Femprox®
in
China, where the cost for conducting clinical studies is significantly lower
than in the U.S. We have been in contact with several potential co-development
partners. We do not intend to conduct additional studies for this product until
we have secured a co-development partner.
We
have
also analyzed our product pipeline for opportunities to license or divest some
of our products under development, with the goal of focusing our attention
on
product opportunities that would replicate the model of our licensed anti-fungal
nail treatment. We have decided to concentrate our development efforts on our
non-patch topical products.
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.
16
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
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, including the
Alprox-TD®
cream
utilizing the NexACT®
technology, has 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.
17
The
studies involved in the approval process are conducted in three phases. In
Phase
1 studies, researchers assess safety or the most common acute adverse effects
of
a drug and examine the size of doses that patients can take safely without
a
high incidence of side effects. Generally, 20 to 100 healthy volunteers or
patients are studied in the Phase 1 study for a period of several months. In
Phase 2 studies, researchers determine the drug's efficacy and short-term safety
by administering the drug to subjects who have the condition the drug is
intended to treat. At the conclusion of the study, an assessment of the correct
dosage level and whether the drug favorably affects the condition is made.
Up to
several hundred subjects may be studied in the Phase 2 study for approximately
6
to 12 months, depending on the type of product tested. In Phase 3 studies,
researchers further assess efficacy and safety of the drug. Several hundred
to
thousands of patients may be studied during the Phase 3 studies for a period
lasting from 12 months to several years. Upon completion of Phase 3 studies,
a
New Drug Application is submitted to the FDA or foreign governmental regulatory
authority for review and approval.
Our
failure to obtain requisite governmental approvals in a timely manner, or at
all, will delay or preclude us from licensing or marketing our products or
limit
the commercial use of our products, which could adversely affect our business,
financial condition and results of operations.
Because
we intend to sell and market our products outside the U.S., we will be subject
to foreign regulatory requirements governing the conduct of clinical trials,
product licensing, pricing and reimbursements. These requirements vary widely
from country to country. Our failure to meet a foreign country's requirements
could delay the introduction of our proposed products in such foreign country
and limit our revenues from sales of our proposed products in foreign
markets.
Successful
commercialization of our products may depend on the availability of
reimbursement to consumers from third-party healthcare payers, such as
government and private insurance plans. Even if we succeed in bringing one
or
more products to market, reimbursement to consumers may not be available or
sufficient to allow us to realize an appropriate return on our investment in
product development or to sell our products on a competitive basis. In addition,
in certain foreign markets, pricing or profitability of prescription
pharmaceuticals is subject to governmental controls. In the U.S., federal and
state agencies have proposed similar governmental control and the U.S. Congress
has recently considered legislative and regulatory reforms that may affect
companies engaged in the healthcare industry. Pricing constraints on our
products in foreign markets and possibly in the U.S. could adversely affect
our
business and limit our revenue.
Liquidity,
Capital Resources and Financial Condition.
We
have
experienced net losses and negative cash flows from operations each year since
our inception. Through March 31, 2007, we had an accumulated deficit of
$127,770,183. 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.
18
As
a
result of our losses to date and accumulated deficit, there is doubt as to
our
ability to continue as a going concern, and, accordingly, our independent
registered public accounting firm has modified its report on our December 31,
2006 consolidated financial statements included in our Annual Report on Form
10-K in the form of an explanatory paragraph describing the events that have
given rise to this uncertainty. These factors may make it more difficult for
us
to obtain additional funding to meet our obligations. Our ability to continue
as
a going concern is based on our ability to generate or obtain sufficient cash
to
meet our obligations on a timely basis and ultimately become profitable.
At
March
31, 2007 we had cash and cash equivalents and short term investments of
approximately $10.7 million as compared to $12.1 million at December 31, 2006.
Our net decrease in cash in the first quarter of 2007 is the result of our
average fixed monthly overhead costs of approximately $450,000 per month. We
project that our cash reserves of $10.1 million as of the date of this report
are sufficient to sustain our operations through approximately the end of 2007
if we are unable to renegotiate our $5 million of notes due in 2007 to be able
to postpone repayment or repay amounts in equity rather than cash. However,
we
believe that we will be able to either renegotiate the notes, sell our facility
in East Windsor, NJ or rely on expected milestone payments from our Novartis
licensing agreement to fund the repayment of the notes. If we are able to
achieve any one of the aforementioned objectives then we project that our cash
reserves of $10.1 million as of the date of this report are sufficient to
sustain our operations for approximately 19 months at the current burn rate
of
approximately $450,000 per month for fixed monthly overhead costs and an
anticipated $1.5 million in expenditures during 2007 required to prepare all
of
the relevant dossiers and assemble the regulatory approval applications for
Alprox-TD®
in the
U.S., Canada and Europe in the first half of 2007. There is no assurance that
we
will be able to renegotiate our notes on terms acceptable to us, if at all.
Further, there is no assurance that milestone payments from our Novartis
licensing agreement will be earned or that we will be able to sell our facility
in East Windsor, NJ.
At
March
31, 2007 we had an other receivable of $0 as compared to $183,700 at December
31, 2006. The other receivable consists of amounts billed to Novartis in
connection with the exclusive global licensing agreement for our NM100060 nail
lacquer. Pursuant to the terms of the agreement, Novartis has agreed to
reimburse us for related patent expenses as well as the remaining costs for
completion of preclinical studies that we had begun prior to the signing of
the
agreement. On February 16, 2007, the Novartis agreement was amended. Pursuant
to
the amendment, the Company is no longer obligated to complete the remaining
preclinical studies for NM100060. Novartis has taken over all responsibilities
related to the remaining preclinical studies. As
such,
we did not bill Novartis for any preclinical reimbursement costs in the first
quarter of 2007 and will not be billing Novartis in any future
periods.
For
the
three months ended March 31, 2007 we incurred no loss on disposal of fixed
assets as compared to $186,381 in 2006. The decrease in loss on disposal of
fixed assets resulted from the consolidation of our operations in 2006 into
our
East Windsor facility which was originally designed for manufacturing with
offices and laboratories. In consolidating our facilities and reducing staff
in
2006 we determined that we had excess laboratory equipment. We wrote off
obsolete equipment and sold many pieces of equipment.
19
To
date,
we have spent approximately $69.1 million on the Alprox-TD®
development program, and anticipate that the remaining cost to prepare all
of
the relevant dossiers and assemble the regulatory approval applications in
the
U.S., Canada and Europe in 2007 will be approximately $1.5 million. We estimate
that an additional $5-7 million will need to be spent on scale-up manufacturing
costs prior to commerialization. We intend to rely on future
commercialization partners for Alprox-TD®
to
assume those expenses along with any additional expenditure that may be required
for the period between regulatory submission of
Alprox-TD®
and its
commercialization. Since we cannot predict the actions of the regulatory
agencies, the level of other research and development activities we may be
engaged in, and our ability to enter into additional partnering agreements,
we
cannot accurately predict the expenditure required for the period between
regulatory submission of Alprox-TDâ and
its
commercialization.
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. Other than the following, there
have
been no material changes to our Critical Accounting Policies described in our
Form 10-K filed with the Securities and Exchange Commission on March 26,
2007.
Stock-Based
Compensation Expense
Effective
January 1, 2006, we account for stock-based compensation costs in
accordance with SFAS 123R, which requires the measurement and recognition of
compensation expense for all stock-based payment awards made to our employees
and directors. Under the fair value recognition provisions of SFAS 123R,
stock-based compensation cost is measured at the grant date based on the value
of the award and is recognized as an expense over the vesting period.
Determining the fair value of stock-based awards at the grant date requires
considerable judgment. Furthermore, judgment is also required in estimating
the
amount of stock-based awards that are expected to be forfeited. If our actual
experience differs significantly from the assumptions used to compute our
stock-based compensation cost, or if different assumptions had been used, we
may
have recorded too much or too little stock-based compensation cost.
Accounting
for Uncertainty in Income Taxes
In
June
2006, the FASB issued FASB Interpretation No. ("FIN") 48 "Accounting for
Uncertainty in Income Taxes" ("FIN48"). FIN 48 sets forth a recognition
threshold and measurement attribute for financial statement recognition of
positions taken or expected to be taken in income tax returns. The required
adoption of FIN 48 as of January 1, 2007 had no material impact on our
consolidated financial statements.
Comparison
of Results of Operations Between the Three Months Ended March 31 of 2007 and
of
2006.
Royalties
and research and development fee revenue.
We
recorded $286,959 in revenue during the first quarter of 2007, as compared
to
$453,947 in revenue during the first quarter of 2006. The revenue consisted
of
$1,200 and $2,203 in 2007 and 2006, respectively, in royalties on sales of
Befar®
received
from our Asian licensee and $285,759 and $451,744, respectively, of revenue
on
our Novartis licensing agreement. The
decrease in revenue in 2007 is primarily attributable to the method used to
recognize revenue from the $4 million up-front payment received in 2005 from
Novartis
under
the
licensing agreement for NM100060.
As
discussed in Note 10 to the Consolidated Financial Statements, the
Novartis agreement was amended in February 2007 such that beginning with the
first quarter of 2007 we are
recognizing the initial up-front payment and preclinical reimbursement revenue
from this agreement based on a straight-line basis over the 18 month period
ended June 30, 2008 rather than the cost-to-cost method over the 32-month period
estimated to complete the remaining preclinical studies for
NM100060.
Accordingly, the Company recognized significantly more revenue in the first
quarter of 2006 as the preclinical studies were initiated because the
high
costs to initiate the preclinical studies in 2005 and early 2006 resulted in
a
larger portion of revenue recognized under the cost-to-cost method in 2006.
20
General
and Administrative Expenses.
Our
general and administrative expenses decreased to $1,232,895 during the first
quarter of 2007 as compared to $1,832,171 during the same period in 2006. The
decrease is primarily due to a decrease in overhead including rent and utilities
of approximately $118,000 as a result of the completion of our consolidation
of
facilities in April 2006. Additionally in the first quarter 2006 we recognized
a
loss on the disposal of equipment of approximately $190,000 as a result of
the
consolidation of our operations. We also had a decrease in general and
administrative salaries of approximately $45,000 as a result of our
restructuring program initially implemented in December 2005 and completed
in
March 2006. There was also a decrease in legal expenses of $48,000 due to our
incurring additional legal expenses in 2006 related to our restructuring program
and also our adopting a new stock option plan in 2006 whereas we had no such
expenses in 2007. We had a decrease in legal fees related to patents of
approximately $99,000 as a result of our decision to reduce the number of
national patent filings we would pursue on early stage pipeline products. There
was also a decrease in compensation expense of approximately $137,000 due to
increased number of stock options issued to Richard Berman and Leonard Oppenheim
who were appointed as Chief Executive Officer and Lead Director, respectively,
in the first quarter of 2006.
Research
and Development Expenses.
Our
research and development expenses for the first quarter of 2007 and 2006 were
$1,077,883 and $1,507,975, respectively. Research and development expenses
in
the first quarter of 2007 included approximately $5,600 attributable to
NM100060, $335,000 attributable to Alprox-TD®
and the
balance attributable to other NexACT®
technology based products and indirect overhead related to research and
development, as compared to approximately $194,000 for NM100060 and $141,000
for
Alprox-TD®
during
the same period in 2006. Research and development expenses related to NM100060
have decreased significantly in 2007, as we are no longer obligated to complete
the remaining preclinical studies for NM100060. Novartis has taken over all
responsibilities related to the remaining preclinical studies whereas in 2006,
we incurred the preclinical study costs and were reimbursed by Novartis. While
our total direct project expenses to third parties has remained consistent,
our
research and development salaries have decreased approximately $378,000 in
the
first quarter of 2007 as a result of our restructuring program initially
implemented in December 2005 and completed in March 2006. Additionally, rent
and
utility expenses directly related to research and development decreased
approximately $50,000 in 2007 as a result of the completion of our consolidation
of facilities in April 2006.
21
Interest
Expense, Net.
We had
interest expense net of interest income of $15,490 during the first quarter
of
2007, as compared to $20,094 during the same period in 2006. The decrease is
due
to a decrease in interest expense related to our capital leases with GE Capital.
Our capital leases were paid in full in 2006 and we no longer incurred interest
expense in 2007 related to these capital leases.
Net
Loss.
The net
loss was $2,039,309 and $2,906,293 in the first quarter of 2007 and 2006,
respectively. The decrease is primarily attributable to our restructuring
program initially implemented in December 2005 and completed in April 2006
whereby we significantly reduced our research and development project
expenditures and staff and reduced our overhead by consolidating our facilities
in 2006.
Net
Loss applicable to Common Stock. The
net
loss applicable to common stock was $2,039,309 or $0.03 per share for first
quarter of 2007 as compared to $2,960,942 or $0.05 per share for 2006. The
decrease is primarily attributable to our restructuring program initially
implemented in December 2005 whereby we significantly reduced our research
and
development project expenditures and staff and reduced our overhead by
consolidating our facilities in 2006. The decrease also resulted from the deemed
dividend to preferred shareholders in 2006 as discussed in Note 7 to 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,
2006.
ITEM
4.
CONTROLS AND PROCEDURES
In
accordance with Exchange Act Rules 13a-15 and 15d-15, the Company's management
carried out an evaluation with participation of the Company's Chief Executive
Officer and Chief Financial Officer, its principal executive officer and
principal financial officer, respectively, of the effectiveness of the Company's
disclosure controls and procedures as of the end of the period covered by this
report. Based upon that evaluation, the Chief Executive Officer and Chief
Financial Officer concluded as of the end of the period covered by this Form
10-Q that the Company's disclosure controls and procedures are effective. There
were no changes in the Company's internal controls over financial reporting
that
occurred during the quarter covered by this report that have materially affected
or are reasonably likely to materially affect the Company's internal controls
over financial reporting.
22
PART
II. OTHER INFORMATION
ITEM
1. LEGAL
PROCEEDINGS
There
have been no material changes to the legal proceedings described in the
Company’s Form 10-K filed with the Securities and Exchange Commission on March
26, 2007.
ITEM
1A. RISK
FACTORS
There
have been no material changes to the risk factors described in the Company’s
Form 10-K filed with the Securities and Exchange Commission on March 26,
2007.
ITEM
2. UNREGISTERED
SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
On
February 28, 2007, the Company issued 28,809 shares of common stock to the
holder of the $2 million Notes in payment of accrued interest for the two month
period ended January 31, 2007 of $25,000. The common stock was issued pursuant
to an exemption provided by Section 4(2) of the Securities Act of
1933.
On
April
1, 2007, the Company issued 59,576 shares of common stock to the holders of
the
Convertible Notes in payment of accrued interest for the six month period ended
March 31, 2007 of $75,833. The common stock was issued pursuant to an exemption
provided by Section 4(2) of the Securities Act of 1933.
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 10, 2007 | /s/ Mark Westgate | |
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