SEELOS THERAPEUTICS, INC. - Quarter Report: 2009 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,
2009.
|
Commission
file number 0-22245
NEXMED, INC.
|
(Exact
Name of Issuer as Specified in Its
Charter)
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Nevada
|
87-0449967
|
|
(State or Other Jurisdiction of
|
(I.R.S. Employer
|
|
Incorporation or Organization)
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Identification No.)
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89 Twin Rivers Drive, East Windsor, NJ
08520
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(Address
of Principal Executive Offices)
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(609) 371-8123
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(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
¨
Indicate by check mark whether the
registrant has submitted electronically and posted on its Corporate Web site, if
any, every Interactive Data File required to be submitted and posted pursuant to
Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter
period that the registrant was required to submit and post such
files).
Yes ¨ No
¨
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer, or a smaller reporting
company. See definitions of “large accelerated filer”, “accelerated
filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act (check
one):
Large
accelerated filer ¨ Accelerated
filer x Non-accelerated
filer ¨(do not
check if a smaller reporting company) Smaller reporting
company ¨
Indicate by check mark whether the
registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
Yes ¨ 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 7, 2009, 84,410,736
shares of Common Stock, par value $0.001 per share, were
outstanding.
Table of
Contents
Page
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|||
Part
I.
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FINANCIAL
INFORMATION
|
||
Item
1.
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Financial
Statements
|
1 | |
Unaudited
Consolidated Balance Sheets at March 31, 2009 and December 31,
2008
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1
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||
Unaudited
Consolidated Statements of Operations for the Three Months Ended March 31,
2009 and March 31, 2008
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2
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||
Unaudited
Consolidated Statements of Cash Flows for the Three Months Ended March 31,
2009 and March 31, 2008
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3
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||
Notes
to Unaudited Consolidated Financial Statements
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4
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||
Item
2.
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Management's
Discussion and Analysis of Financial Condition and Results of
Operations
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16
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Item
3.
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Quantitative
and Qualitative Disclosures about Market Risk
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23
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Item
4.
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Controls
and Procedures
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24
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Part
II.
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OTHER
INFORMATION
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||
Item
1.
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Legal
Proceedings
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24
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Item
1A.
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Risk
Factors
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24
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Item
6.
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Exhibits
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25
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Signatures
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26
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||
Exhibit
Index
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27
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PART
I. FINANCIAL INFORMATION
ITEM 1. FINANCIAL
STATEMENTS
NexMed,
Inc.
Consolidated
Balance Sheets
March 31,
|
December 31,
|
|||||||
2009
|
2008
|
|||||||
(Unaudited)
|
||||||||
Assets
|
||||||||
Current
assets:
|
||||||||
Cash
and cash equivalents
|
$ | 3,758,044 | $ | 2,862,960 | ||||
Debt
issuance cost, net of accumulated amortization of $42,283 and $42,283
- current portion
|
30,368 | 30,368 | ||||||
Other
receivable
|
175,000 | - | ||||||
Prepaid
expenses and other assets
|
91,123 | 83,761 | ||||||
Total
current assets
|
4,054,535 | 2,977,089 | ||||||
Fixed
assets, net
|
5,104,610 | 5,519,652 | ||||||
Debt
issuance cost, net of accumulated amortization of $79,014 and
$86,607
|
53,179 | 60,771 | ||||||
Total
assets
|
$ | 9,212,324 | $ | 8,557,512 | ||||
Liabilities, convertible preferred stock and
stockholders' equity
|
||||||||
Current
liabilities:
|
||||||||
Accounts
payable and accrued expenses
|
$ | 727,252 | $ | 1,029,486 | ||||
Payroll
related liabilities
|
161,879 | 296,135 | ||||||
Deferred
revenue - current portion
|
10,200 | - | ||||||
Deferred
compensation - current portion
|
63,135 | 74,245 | ||||||
Total
current liabilities
|
962,466 | 1,399,866 | ||||||
Long
Term liabilities:
|
||||||||
Convertible
notes payable
|
4,690,000 | 4,690,000 | ||||||
Deferred
revenue
|
90,100 | - | ||||||
Deferred
compensation
|
920,611 | 935,517 | ||||||
Total
Liabilities
|
6,663,177 | 7,025,383 | ||||||
Commitments
and contingencies (Note 9)
|
||||||||
Stockholders'
equity:
|
||||||||
Common
stock, $.001 par value, 120,000,000 shares authorized, 84,410,736 and
84,350,361 and outstanding, respectively
|
84,412 | 84,352 | ||||||
Additional
paid-in capital
|
141,469,263 | 141,137,077 | ||||||
Accumulated
deficit
|
(139,004,528 | ) | (139,689,300 | ) | ||||
Total
stockholders' equity
|
2,549,147 | 1,532,129 | ||||||
Total
liabilities and stockholder's equity
|
$ | 9,212,324 | $ | 8,557,512 |
See notes
to unaudited consolidated financial statements.
1
NexMed,
Inc.
Consolidated
Statements of Operations (Unaudited)
FOR THE THREE MONTHS
|
||||||||
ENDED MARCH 31,
|
||||||||
2009
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2008
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|||||||
Revenues,
principally license fee revenue
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$ | 2,466,670 | $ | 951,787 | ||||
Operating
expenses
|
||||||||
Research
and development
|
602,366 | 1,169,091 | ||||||
General
and administrative
|
1,091,047 | 1,303,398 | ||||||
Total
operating expenses
|
1,693,413 | 2,472,489 | ||||||
Income
(loss) from operations
|
773,257 | (1,520,702 | ) | |||||
Interest
expense, net
|
(88,485 | ) | (121,485 | ) | ||||
Net
income (loss)
|
684,772 | (1,642,187 | ) | |||||
Basic
and diluted income (loss) per common share
|
$ | 0.01 | $ | (0.02 | ) | |||
Weighted
average common shares outstanding used for basic and diluted income (loss)
per share
|
84,388,421 | 83,094,347 |
See notes
to unaudited consolidated financial statements.
2
NexMed,
Inc.
Consolidated
Statements of Cash Flows (Unaudited)
FOR THE THREE MONTHS ENDED
|
||||||||
MARCH 31,
|
||||||||
2009
|
2008
|
|||||||
Cash
flows from operating activities
|
||||||||
Net
income (loss)
|
$ | 684,772 | $ | (1,642,187 | ) | |||
Adjustments
to reconcile net income (loss) to net cash provided by (used in)
operating activities
|
||||||||
Depreciation
and amortization
|
108,882 | 126,595 | ||||||
Non-cash
interest, amortization of debt discount and deferred financing
costs
|
7,592 | 93,903 | ||||||
Non-cash
compensation expense
|
332,246 | 301,870 | ||||||
(Gain)
loss on disposal of fixed assets
|
(43,840 | ) | 2,605 | |||||
(Increase)
decrease in prepaid expenses and other assets
|
(7,362 | ) | 11,810 | |||||
Decrease
in accounts payable and accrued expenses
|
(302,234 | ) | (17,419 | ) | ||||
Decrease
in payroll related liabilities
|
(134,256 | ) | (542,344 | ) | ||||
Decrease
in deferred compensation
|
(26,016 | ) | (14,945 | ) | ||||
Increase
in deferred revenue
|
100,300 | 551,014 | ||||||
Net
cash provided by (used in) operating activities
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720,084 | (1,129,098 | ) | |||||
Cash
flows from investing activities
|
||||||||
Proceeds
from sale of fixed assets
|
175,000 | - | ||||||
Capital
expenditures
|
- | (14,033 | ) | |||||
Proceeds
from sale of marketable securities and short term
investments
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- | 750,000 | ||||||
Net
cash provided by investing activities
|
175,000 | 735,967 | ||||||
Cash
flows from financing activities
|
||||||||
Proceeds
from exercise of stock options and warrants
|
- | 39,750 | ||||||
Net
cash provided by financing activities
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- | 39,750 | ||||||
Net
increase (decrease) in cash and cash equivalents
|
895,084 | (353,381 | ) | |||||
Cash
and cash equivalents, beginning of period
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$ | 2,862,960 | $ | 2,735,940 | ||||
Cash
and cash equivalents, end of period
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$ | 3,758,044 | $ | 2,382,559 | ||||
Supplemental
Information:
|
||||||||
Other
receivable from sale of fixed assets
|
$ | 175,000 | $ | - |
See notes
to unaudited consolidated financial statements.
3
NexMed,
Inc.
Notes
to Unaudited
Consolidated
Financial Statements
1. BASIS OF
PRESENTATION
The accompanying unaudited consolidated
financial statements have been prepared in accordance with accounting principles
generally accepted in the United States of America for interim financial
information and with the instructions to Form 10-Q and Article 10-01 of
Regulation S-X. Accordingly, they do not include all of the
information and footnotes required by accounting principles generally accepted
in the United States of America for annual financial statements. In
the opinion of management, all adjustments (consisting of normal recurring
accruals) considered necessary for a fair statement have been
included. Operating results for the three months ended March 31, 2009
are not necessarily indicative of the results that may be expected for the year
ending December 31, 2009. 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, 2008.
The Company had an accumulated deficit
of $139,004,528 at March 31, 2009, and the Company expects to incur additional
losses during the remainder of 2009. While the Company showed net
income for the three months ended March 31, 2009, 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, 2008 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 or partnering arrangements to fund operations,
including continued research, development and clinical trials of the Company’s
product candidates. The
Company has engaged an investment banker to explore strategic
alternatives. There is no assurance that the Company will be
successful in obtaining financing or partnering arrangements on terms acceptable
to it. If additional financing or partnering arrangements 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.
The Company’s Common Stock trades on the Nasdaq
Capital Market. On October 9, 2008, the Company was notified by The Nasdaq Stock Market
(“Nasdaq”) that for the previous 30 consecutive trading days our Common Stock
closed below the minimum $1.00 per share requirement for continued inclusion by
Marketplace Rule 4310(c)(8)(D). Pursuant to Marketplace Rule
4310(c)(8)(E), the Company
was provided 180 calendar
days, or until April 7, 2009, to regain compliance.
4
On October 22, 2008, the Company was notified by Nasdaq that effective
October 16, 2008 it had suspended enforcement of the bid price requirement until
January 16, 2009. Further, on December 23, 2008 and again on March 23, 2009,
we were notified by Nasdaq
that it had suspended the enforcement of the bid price requirement until
July 20, 2009. As such, since
the Company had 174 days remaining in our
compliance period, it now has 174 days from July 20, 2009, or until January 9, 2010, to regain
compliance.
Accordingly,
the Company’s Common Stock must achieve a minimum bid price of $1.00 for a
minimum of 10 consecutive days during the period ending January 9, 2010 in order
to maintain our listing on the Nasdaq Capital Market.
If the
Company fails to achieve the minimum bid price requirement of the Nasdaq Capital
Market by January 9, 2010 or fails to maintain compliance with any other listing
requirements during this period, the Company may be delisted and its stock would
be considered a penny stock under regulations of the Securities and Exchange
Commission and would therefore be subject to rules that impose additional sales
practice requirements on broker-dealers who sell the Company’s securities. The
additional burdens imposed upon broker-dealers by these requirements could
discourage broker-dealers from effecting transactions in the Company’s Common
Stock, which could severely limit the market liquidity of the Common Stock and a
stockholder’s ability to sell the Common Stock in the secondary market. In
addition, if the Company fails to maintain its listing on Nasdaq or any other
United States securities exchange, quotation system, market or over-the-counter
bulletin board, the Company will be subject to cash penalties under investor
rights agreements to which it is a party until a listing is
obtained.
On March
19, 2009, the Company was notified
by Nasdaq indicating that it did not comply with the minimum $2.5
million in stockholders’ equity requirement for continued listing on the Nasdaq
Capital Market set forth in Rule 5550(b)(1) (formerly Marketplace Rule
4310(c)(3)). Additionally, the Company
did not comply with the alternative
listing requirements
of market value of listed
securities of $35 million or $500,000 of net income from continuing operations
for the most recently completed fiscal year or two of the three most recently
completed fiscal years, as
set forth in Rules 5550(b)(2) and 5550(b)(3), respectively.
Accordingly, on April 3, 2009, the Company submitted a
plan to regain compliance with the $2.5 million stockholders’ equity
requirement. On April 22, 2009 Nasdaq granted the Company an extension of time to regain
compliance. In that regard, Nasdaq required that the Company demonstrate that it has achieved compliance with the minimum $2.5 million in
stockholders’ equity requirement as evidenced by the Consolidated
Balance Sheet contained in this
report. Therefore, per the Balance Sheet
contained in this report, the Company has demonstrated compliance with the
minimum stockholders’ equity requirement and it will not be subject to delisting
from Nasdaq at this time. However,
Nasdaq will continue to monitor the Company’s ongoing compliance with the
stockholder’s equity requirement and should the Company not maintain $2.5
million in stockholders’ equity through June 30, 2009, the Company may again be
subject to Nasdaq’s delisting procedures on this basis.
5
2. ACCOUNTING
FOR STOCK BASED COMPENSATION
In December 1996, the Company adopted
the NexMed, Inc. Stock Option and Long-Term Incentive Compensation Plan (the
“Incentive Plan”) and the NexMed, Inc. Recognition and Retention Stock Incentive
Plan (the “Recognition Plan”). A total of 2,000,000 shares were set
aside for these two plans. In May 2000, the Company’s stockholders
approved an increase in the number of shares reserved for the Incentive Plan and
Recognition Plan to a total of 7,500,000. In June 2006, the Company
adopted the NexMed, Inc. 2006 Stock Incentive Plan. A total of
3,000,000 shares were set aside for the plan and an additional 2,000,000 shares
were added to the plan in June 2008. Options granted under the
Company’s plans generally vest over a period of one to five years, with exercise
prices of currently outstanding options ranging from $0.55 to $12.00. The maximum term
under these plans is 10 years.
The
Company follows the provisions of Statement of Financial Accounting Standards
No. 123R, “Share-Based Payment” (“SFAS 123R”), which establishes the
financial accounting and reporting standards for stock-based compensation plans.
SFAS 123R requires the measurement and recognition of compensation expense for
all stock-based awards made to employees and directors, including employee stock
options and restricted stock. Under the provisions of SFAS 123R,
stock-based compensation cost is measured at the grant date, based on the
calculated fair value of the award, and is recognized as an expense on a
straight-line basis over the requisite service period of the entire award
(generally the vesting period of the award). The Company adopted the
modified prospective transition method as prescribed by SFAS
123R. Under this transition method, stock-based compensation
expense for the three months ended March 31, 2009 and March 31, 2008 includes
expense for all equity awards granted during the three months ended March 31,
2009 and March 31, 2008 and prior, but not yet vested as of January 1, 2006 (the
adoption date of SFAS 123R), based on the grant date fair value estimated in
accordance with the original provisions of SFAS No. 123, “Accounting
for Stock-Based Compensation” (“SFAS 123,”) as amended by SFAS 148, “Accounting
for Stock-Based Compensation—Transition and Disclosure.” The following table
indicates where the total stock-based compensation expense resulting from stock
options and awards appears in the Statement of Operations
(unaudited):
FOR THE THREE MONTHS
|
||||||||
ENDED MARCH 31,
|
||||||||
2009
|
2008
|
|||||||
Research
and development
|
$ | 47,515 | $ | 9,183 | ||||
General
and administrative
|
284,731 | 292,687 | ||||||
Stock-based
compensation expense
|
$ | 332,246 | $ | 301,870 |
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.
6
The
Company accounts for stock and stock options granted to non-employees on a fair
value basis in accordance with SFAS No. 123, “Accounting for
Stock-Based Compensation,” and Emerging
Issues Task Force Issue No. 96-18, “Accounting for
Equity Instruments That Are Issued to Other Than Employees for Acquiring, or in
Conjunction with Selling, Goods or Services.” Any stock or
stock options issued to non-employees are recorded in the consolidated financial
statements using the fair value method and then amortized to expense over the
applicable service periods. As a result, the non-cash charge to operations for
non-employee options with vesting or other performance criteria is valued each
reporting period based upon changes in the fair value of Common
Stock.
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, 2009 and March 31, 2008:
Dividend
yield
|
0.00 | % | ||
Risk-free
yields
|
1.35% - 5.02 | % | ||
Expected
volatility
|
54.38% - 103.51 | % | ||
Expected
option life
|
1 -
6 years
|
|||
Forfeiture
rate
|
6.41 | % |
Expected Volatility. The
Company uses analysis of historical volatility to compute the expected
volatility of its stock options.
Expected Term. The expected
term is based on several factors including historical observations of employee
exercise patterns during the Company’s history and expectations of employee
exercise behavior in the future giving consideration to the contractual terms of
the stock-based awards.
Risk-Free Interest Rate. The
interest rate used in valuing awards is based on the yield at the time of grant
of a U.S. Treasury security with an equivalent remaining term.
Dividend Yield. The Company
has never paid cash dividends, and does not currently intend to pay cash
dividends, and thus has assumed a 0% dividend yield.
Pre-Vesting Forfeitures.
Estimates of pre-vesting option forfeitures are based on Company experience. The
Company will adjust its estimate of forfeitures over the requisite service
period based on the extent to which actual forfeitures differ, or are expected
to differ, from such estimates. Changes in estimated forfeitures will be
recognized through a cumulative catch-up adjustment in the period of change and
will also impact the amount of compensation expense to be recognized in future
periods. The cumulative effect resulting from initially applying the provisions
of SFAS 123R to nonvested equity awards was not significant. The
Company’s current forfeiture rate is 6.41%.
7
Stock
Options and Restricted Stock
Presented
below is a summary of the status of Company stock options as of March 31, 2009,
and related transactions for the three month period then ended
(unaudited):
Options Outstanding
|
Options Exercisable
|
||||||||||||||||||||||||
Weighted Average
|
Aggregate
|
Aggregate
|
|||||||||||||||||||||||
Range of
|
Number
|
Remaining
|
Weighted Average
|
Intrinsic
|
Number
|
Weighted Average
|
Intrinsic
|
||||||||||||||||||
Exercise Prices
|
Outstanding
|
Contractual Life
|
Exercise Price
|
Value
|
Exercisable
|
Exercise Price
|
Value
|
||||||||||||||||||
$ .55
- 1.85
|
2,763,589 |
6.60
years
|
$ | 0.86 | $ | - | 2,592,884 | $ | 0.83 | $ | - | ||||||||||||||
2.00
- 3.99
|
81,250 |
3.00
years
|
3.29 | - | 81,250 | 2.83 | - | ||||||||||||||||||
4.00
- 5.50
|
373,651 |
3.26
years
|
4.65 | - | 373,651 | 4.65 | - | ||||||||||||||||||
7.00
- 12.00
|
18,000 |
1.18
years
|
8.67 | - | 18,000 | 8.67 | - | ||||||||||||||||||
|
|||||||||||||||||||||||||
3,236,490 |
6.09
years
|
$ | 1.40 | $ | - | 3,065,785 | $ | 1.41 | $ | - |
Weighted
|
Weighted
|
Total
|
|||||||||||
Average
|
Average Remaining
|
Aggregate
|
|||||||||||
Number of
|
Exercise
|
Contractual
|
Intrinsic
|
||||||||||
Shares
|
Price
|
Term
|
Value
|
||||||||||
Outstanding
at December 31, 2008
|
3,368,991 | $ | 1.40 | - | |||||||||
Granted
|
- | $ | - | ||||||||||
Exercised
|
- | $ | - | - | |||||||||
Forfeited
|
(132,501 | ) | $ | 1.23 | - | ||||||||
Outstanding
at March 31, 2009
|
3,236,490 | $ | 1.40 |
6.09
years
|
$ | 0 | |||||||
Vested
or expected to vest at
|
|||||||||||||
March
31, 2009
|
3,029,031 | $ | 1.40 |
6.09
years
|
$ | 0 | |||||||
Exercisable
at March 31, 2009
|
3,065,785 | $ | 1.41 |
5.97
years
|
$ | 0 |
No
options were granted or exercised during the three months ended March 31,
2009. 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 was $43,270. Cash received from option exercises
for the three months ended March 31, 2008 was $39,750.
8
Compensatory Share
Issuances
The value
of restricted stock grants is calculated based upon the closing stock price of
the Company’s common stock on the date of the grant. The value of the
grant is expensed over the vesting period of the grant in accordance with SFAS
123R as discussed above.
Principal
stock based compensation transactions for the three months ended March 31, 2009
were as follows:
On
January 9, 2009, each of the four non-employee Directors was awarded a grant of
shares of Common Stock for their services to be rendered to the Board of
Directors during the first six months of the 2009 calendar year. The
deemed price per share (the “Price”) of $1.47 is the
average of the closing price of the Common Stock over five consecutive trading
days, commencing on January 2, 2008. The number of shares was
calculated based on the amount of cash the Director would have received for
service on the Board, divided by the Price. Therefore each
non-employee director received an award of 21,416 shares of Common Stock of
which 3,569.33 shares vest on the 9th day of
each month from January through June 2009.
Also on
January 9, 2009, Richard Berman was awarded a grant of shares of Common Stock
for his services as Chairman to be rendered to the Board of Directors during the
first six months of the 2009 calendar year. The deemed price per
share (the “Price”) of $1.47 is the
average of the closing price of the Common Stock over five consecutive trading
days, commencing on January 2, 2008. The number of shares was
calculated based on the amount of cash the Director would have received for
service on the Board, divided by the Price. Therefore Mr. Berman
received an award of 41,079 shares of Common Stock of which 6,846.50 shares vest
on the 9th day of
each month from January through June 2009.
3. WARRANTS
At March
31, 2009, 12,118,044 warrants with a weighted average exercise price of $1.23
remained outstanding. For the three months ended March 31, 2009, no
warrants were exercised, issued, cancelled or forfeited.
4. INCOME
(LOSS) PER SHARE
At March
31, 2009 and 2008, respectively, options to acquire 3,236,490 and 3,408,991
shares of Common Stock with exercise prices ranging from $0.55 to $12.00 per
share and warrants to acquire 12,118,044 and 12,439,954 shares of Common Stock
with exercise prices ranging from $0.55 to $3.00 and convertible securities
convertible into 2,946,429 and zero shares of Common Stock at a weighted average
conversion price of $1.95 were excluded from the calculation of diluted income
(loss) per share, as their effect would be anti-dilutive. Income
(loss) per share for the three months ended March 31, 2009 and 2008 was
calculated as follows: (net income (loss) / weighted average common shares
outstanding).
9
FOR THE THREE MONTHS
|
||||||||
ENDED MARCH 31,
|
||||||||
2009
|
2008
|
|||||||
Net
income (loss)
|
$ | 684,772 | $ | (1,642,187 | ) | |||
Weighted
average common shares outstanding
|
||||||||
used
for basic and diluted income (loss) per share
|
84,388,421 | 83,094,347 | ||||||
Basic
and diluted income (loss) per common share
|
$ | 0.01 | $ | (0.02 | ) |
5. CONVERTIBLE
NOTES PAYABLE
On June 30, 2008, the Company
issued convertible notes (the “Convertible Notes”) in an aggregate
principal amount of $5.75 million. The Convertible Notes are
collateralized by the Company’s facility in East Windsor, New
Jersey. $4.75 million principal amount of the Convertible Notes
are due on December
31, 2011 (the “Due
Date”) and $1
million principal amount of the Convertible Notes were due on December 31,
2008. On October 16,
2008, the Company sold certain building equipment and received proceeds of
$60,000 which was used to prepay a portion of the $4.75 million payment due on
December 31, 2011. On December 31, 2008, the Company paid the $1
million principal payment due in cash. As such, the balance of
$4,690,000 is due on December 31, 2011 and is recorded as Convertible notes
payable on the Consolidated
Balance Sheet at
March 31, 2009 and December 31, 2008. The Convertible Notes are
payable in cash or convertible into shares of Common Stock with the remaining principal amount of
$4.69 million convertible at $2
per share on or before the Due Date at the
holders’ option. The Convertible Notes have a coupon rate of 7% per
annum, which is payable at the Company’s option in cash or, if the Company’s net
cash balance is less than $3 million at the time of payment, in shares of Common
Stock. If paid in shares of Common Stock, then the price of the stock
issued will be the lesser of $0.08 below or 95% of the five-day weighted average
of the market price of the Common Stock prior to the time of
payment. Such additional interest consideration is considered
contingent and therefore would only be recognized upon
occurrence.
As discussed in Note 10, the Company sold $350,000 of
manufacturing equipment to Warner. The note holders agreed to release
the lien on the equipment in exchange for a $50,000 repayment of principal to be
paid in 2009 when the equipment is transferred to Warner.
On April 1, 2009, the Company paid
$101,743 in cash for interest on the Note for the period January 1, 2009 through
March 31, 2009.
10
6.
NOTES PAYABLE
October 2007
Note
On October 26, 2007, the Company issued a note in a principal
amount of $3 million. The note was payable on June 30, 2009 and could
be prepaid by the Company at any time without penalty. Interest
accreted on the note on a quarterly basis at a rate of 8.0% per
annum. The note was collateralized by the Company’s facility in East
Windsor, New Jersey.
The Company also issued to the
noteholder a 5-year detachable warrant to purchase 450,000 shares of Common
Stock at an exercise price of $1.52 per share. Of the total warrants
issued, warrants to purchase 350,000 shares vested immediately and the remaining
warrants would have vested if the note had remained outstanding on October 26,
2008. The Company valued the warrants using the Black-Scholes pricing
model. The Company allocated a relative fair value of $512,550
to the warrants. The relative fair value of the warrants is allocated
to additional paid-in capital and treated as a discount to the note that was
being amortized over the 20-month period ending June 30,
2009.
This note was paid on June 30, 2008 with
the proceeds from the issuance of the Convertible Notes referred to above in
Note 5. The Company paid in cash the $3 million balance on the note
plus accrued interest of $60,000. Additionally, the remaining
warrants to purchase 100,000 shares of Common Stock that were to vest on October
26, 2008 were cancelled.
For the three months ended March 31,
2008, the Company recorded $76,883 of amortization related to the note
discount.
7.
DEFERRED
COMPENSATION
On
February 27, 2002, the Company entered into an employment agreement with Y.
Joseph Mo, Ph.D., that had a constant term of five years, and pursuant to which
Dr. Mo would serve as the Company's Chief Executive Officer and
President. Under the employment agreement, Dr. Mo was entitled to
deferred compensation in an annual amount equal to one sixth of the sum of his
base salary and bonus for the 36 calendar months preceding the date on which the
deferred compensation payments commenced subject to certain limitations,
including annual vesting through January 1, 2007, as set forth in the employment
agreement. The deferred compensation is payable monthly for 180
months commencing on termination of employment. Dr. Mo’s employment
was terminated as of December 15, 2005. At such date, the Company
accrued deferred compensation of $1,178,197 based upon the estimated present
value of the obligation. The monthly deferred compensation payment
through May 15, 2021 is $9,158. As of March 31, 2009, the Company has
accrued $983,746 in deferred compensation.
11
8.
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 and tax balance sheets in the foreseeable
future, and has recorded a valuation allowance of an equal amount to fully
offset the deferred tax benefit amount.
None of the net operating loss
carry-forwards are limited by Internal Revenue Code Section 382, however,
subsequent changes in ownership of the Company may trigger a limitation in the
ability to utilize the net operating loss carry-forwards each
year.
In June 2006, the FASB issued FASB
Interpretation No. (“FIN”) 48 “Accounting for
Uncertainty in Income Taxes” (“FIN 48”). FIN 48 sets
forth a recognition threshold and measurement attribute for financial statement
recognition of positions taken or expected to be taken in income tax returns.
FIN 48 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.
9.
COMMITMENTS AND
CONTINGENCIES
The
Company was a party to clinical research agreements with a clinical research
organization (“CRO”) in connection with a one-year open-label study for
Vitaros® with
commitments by the Company that initially totaled approximately $12.8
million. These agreements were amended in October 2005 such that the
total commitment was reduced to approximately $4.2 million. These
agreements provided that if the Company canceled 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. On September 30, 2008, the clinical research
agreements were cancelled as it was determined that the one-year open-label
study would no longer be required by the FDA for regulatory approval of
Vitaros®. As
such, a cancellation fee of approximately $892,000 was accrued at September 30,
2008. Pursuant to the terms of the clinical research agreement, the
cancellation fee was not payable until December 15, 2008. On December
31, 2008 and March 31, 2009, the Company paid $300,000 toward the total
cancellation fee. The balance of approximately $292,000 is included
in accounts payable and accrued expenses in the Consolidated Balance Sheet at
March 31, 2009.
10.
LICENSING AND RESEARCH AND
DEVELOPMENT 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 (“Vitaros®”). Under
the agreement, Warner acquired the exclusive rights in the United States to
Vitaros® and
would 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 was eligible to receive royalties in the future based upon the level
of sales achieved by Warner, assuming the product is approved by the U.S. Food
and Drug Administration (“FDA”).
12
The
Company has recognized the initial up-front payment as revenue on a straight
line basis over the nine month period ended July 31, 2008 which was the
remaining review time by the FDA for the Company’s new drug application filed in
September 2007 for Vitaros®. Pursuant
to the agreement, NexMed was responsible for obtaining regulatory approval of
Vitaros®.
Accordingly, for the three months ended March 31, 2008, the Company recognized
licensing revenue of $166,667 related to the Warner agreement.
On
February 3, 2009, the Company terminated the licensing agreement and sold the
U.S. rights for Vitaros® to
Warner. Under the terms of the Asset Purchase Agreement, the Company
received an up-front payment of $2.5 million and is eligible to receive an
additional payment of $2.5 million upon Warner’s receipt of a New Drug
Application (NDA) approval for Vitaros® from the
FDA. As such, the Company is no longer responsible for obtaining
regulatory approval of Vitaros® and
will no longer be eligible to receive royalties in the future based upon the
level of sales achieved by Warner. In addition, Warner will pay a
total of $350,000 for the manufacturing equipment for Vitaros®. While
the Company believes that Warner is currently moving forward in pursuing NDA
approval for Vitaros®, Warner
is not obligated by the Asset Purchase Agreement to continue with the
development of Vitaros® or
obtain approval of Vitaros® from the
FDA. The
Company allocated $2,398,000 of the $2,500,000 purchase price to the U.S. rights
for Vitaros® and
the related patents acquired by Warner. The balance of $102,000 was
allocated to the rights of certain technology based patents which Warner
licensed as part of the sale of U.S. rights for Vitaros®. The
$2,398,000 is recognized as revenue for the three months ended March 31, 2009,
as the Company has no continuing obligations or rights with respect to
Vitaros® in the
U.S. market. The $102,000 allocated to the patent license is being
recognized over a period of ten years, the estimated useful commercial life of
the patents. Accordingly, $1,700 is being recognized as revenue for
the three months ended March 31, 2009. The balance of $100,300 is
recorded as deferred revenue on the Consolidated Balance Sheet at March 31,
2009.
The
Company recognized a gain during the three months ended March 31, 2009 of
$43,840 on the sale of the manufacturing equipment to Warner. Warner
paid $175,000 of the total $350,000 purchase price for equipment upon signing
the Asset Purchase Agreement. The balance of $175,000 will be paid
upon Warner’s first use of the equipment but no later than May 15,
2009. The $175,000 balance is recorded as an other receivable on the
Consolidated Balance Sheet at March 31, 2009.
On April 15, 2009, the Company entered into a First Amendment (the
“Amendment”) to the Asset Purchase Agreement. The Amendment provides that from May 15,
2009 through September 15, 2009, the Company will permit certain representatives
of Warner access to and use of the Company’s manufacturing facility for the
purpose of manufacturing Vitaros®, and in connection therewith the
Company will provide reasonable technical and other assistance to
Warner. In consideration, Warner will pay to the Company a fee of
$50,000 per month, or $200,000 in the aggregate. The arrangement is
subject to extension for successive 30 day periods for additional consideration
of $50,000 per month until
terminated by either party prior to the expiration of each successive
period.
13
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 began recognizing the initial up- front and preclinical reimbursement
revenue from this agreement based on the cost-to-cost method over the 32-month
period estimated to complete the remaining preclinical studies for
NM100060. On February 16, 2007, the Novartis agreement was
amended. Pursuant to the amendment, the Company is no longer
obligated to complete the remaining preclinical studies for
NM100060. Novartis has taken over all responsibilities related
to the remaining preclinical studies. As such, the balance of
deferred revenue of $1,693,917 at December 31, 2006 was recognized as revenue on
a straight line basis over the 18 month period ended June 30, 2008 which was the
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 $4 million cash payment
from the Novartis agreement.
On March
4, 2008, the Company received a $1.5 million milestone payment from Novartis
pursuant to the terms of the licensing agreement whereby the payment was due
seven months after the completion of patient enrollment for the Phase 3 clinical
trials for NM100060, which occurred in July 2007. Although the
completion of patient enrollment in the Phase 3 clinical trials for NM100060
triggered a $3 million milestone payment from Novartis, the agreement also
provided that clinical milestones paid to us by Novartis shall be reduced by 50%
until the Company receives an approved patent claim on the NM100060 patent
application filed with the U.S. patent office in November 2004. The
$1.5 million milestone payment was recognized on a straight-line basis over the
six month period 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.
In July
2008, Novartis completed testing for the Phase 3 clinical trials for NM100060
required for the filing of the NDA in the U.S. On August 26, 2008,
the Company announced that Novartis had decided not to submit the NDA in the
U.S. based on First Interpretable Results of the Phase 3 trials. As a result of
this decision, the Company did not receive a $6 million payment for positive
Phase 3 results, and a $7 million milestone payment due upon filing of the NDA
has been postponed indefinitely.
On
October 17, 2008, the Company received a Notice of Allowance for its U.S. patent
covering NM100060. Pursuant to the license agreement, the payment of
the issuance fee for an approved patent claim on NM100060 triggered the $2
million patent milestone payment from Novartis. Additionally, $1.5
million, which represents the remaining 50% of the patient enrollment milestone
also became due and payable. As such the Company received a payment
of $3.5 million from Novartis on October 30, 2008 and recognized it as licensing
revenue for the year ended December 31, 2008.
14
Novartis
has confirmed that it intends to complete patient testing in the ongoing
comparator study which it had initiated in March 2007 in ten European
countries. Over 900 patients with mild to moderate onychomycosis are
participating in this open-label study, which is designed to assess the safety
and tolerability of NM100060 (terbinafine 10% topical formulation) versus
Loceryl®
(amorolfine) 5% nail lacquer, a topical treatment for onychomycosis that is
approved in Europe. The patient testing has been completed and the data will be
available in mid-2009. If the results of the comparator study are
positive and the total clinical database is deemed to be sufficient for filing,
the Company expects Novartis to begin filing for marketing approval in selected
European countries while they develop a new plan of action for the U.S.
market. If the results are negative, the Company expects Novartis to
terminate the global licensing agreement, which it can do at any time, and the
rights to NM100060 would revert back to the Company with no compensation for
termination.
15
ITEM 2.
|
MANAGEMENT'S DISCUSSION AND
ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
OPERATIONS
|
Disclosures
Regarding Forward-Looking Statements.
The
following should be read in conjunction with the unaudited consolidated
financial statements and the related notes that appear elsewhere in this
document as well as in conjunction with the Risk Factors section herein and in
our Form 10-K for the year ended December 31, 2008 filed with the Securities and
Exchange Commission on March 16, 2009. 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 U.S. Food and Drug
Administration (“FDA”), (2) with proven efficacy and safety profiles, (3) with
patents expiring or expired and (4) with proven market track records and
potential.
16
NM100060
Anti-Fungal Treatment
We have
an exclusive global licensing agreement with Novartis International
Pharmaceutical Ltd. (“Novartis”) for NM100060, our proprietary topical nail
solution for the treatment of onychomycosis (nail fungal infection). Under the
agreement, Novartis acquired the exclusive worldwide rights to NM100060 and has
assumed all further development, regulatory, manufacturing and commercialization
responsibilities as well as costs. Novartis agreed to pay us up to $51 million
in upfront and milestone payments on the achievement of specific development and
regulatory milestones, including an initial cash payment of $4 million at
signing. In addition, we are eligible to receive royalties based upon
the level of sales achieved.
The
completion of patient enrollment in the Phase 3 clinical trials for NM100060
triggered a $3 million milestone payment from Novartis to be paid 7 months after
the last patient enrolled in the Phase 3 studies. However, the
agreement also provided that clinical milestones paid to us by Novartis would be
reduced by 50% until we received an approved patent claim on the
NM100060. As such, we initially received only $1.5 million from
Novartis.
On
October 17, 2008, the U.S. Patent and Trademark Office issued the Notice of
Allowance on our patent application for NM100060. This triggered a $2
million milestone payment from Novartis. On October 30, 2008 we
received a payment of $3.5 million from Novartis consisting of the balance of
$1.5 million of the patient enrollment milestone and the $2 million patent
milestone.
In July
2008, Novartis completed testing for the Phase 3 clinical trials for
NM100060. The Phase 3 program required for the filing of the New Drug
Application (“NDA”) in the U.S. for NM100060 consisted of two pivotal,
randomized, double-blind, placebo-controlled studies. The parallel
studies were designed to assess the efficacy, safety and tolerability of
NM100060 in patients with mild to moderate toenail
onychomycosis. Approximately 1,000 patients completed testing in the
two studies, which took place in the U.S., Europe, Canada and
Iceland. On August 26, 2008, we announced that based on First
Interpretable Results of these two Phase 3 studies, Novartis had decided not to
submit the NDA at that time. As a result of this decision, we did not
receive a $6 million milestone payment for positive Phase 3 results and a $7
million milestone payment for the filing of the NDA has been postponed
indefinitely.
Novartis
has confirmed that it intends to complete patient testing in an ongoing
comparator study which it had initiated in March 2007 in ten European
countries. Over 900 patients with mild to moderate onychomycosis are
participating in this open-label study, which is designed to assess the safety
and tolerability of NM100060 (terbinafine 10% topical formulation) versus
Loceryl®
(amorolfine) 5% nail lacquer, a topical treatment for onychomycosis that is
approved in Europe. Patient testing has been completed and the data will be
available in mid-2009. If the results of the comparator study are
positive and the total clinical database is deemed to be sufficient for filing,
we expect Novartis to begin filing for marketing approval in selected European
countries while they develop a new plan of action for the U.S.
market. If the results are negative, we expect Novartis to terminate
the global licensing agreement, which it can do at any time, and the rights to
NM100060 would revert back to us with no compensation for
termination.
17
Vitaros®
We also
have under development a topical alprostadil-based cream treatment intended for
patients with erectile dysfunction (“Vitaros®”), which
was previously known as Alprox-TD®. Our
NDA was filed and accepted for review by the FDA in September and November 2007,
respectively. During a teleconference with the FDA in early July
2008, our use of the name Vitaros® for the
ED Product was verbally approved by the FDA.
On
November 1, 2007, we licensed the U.S. rights of Vitaros® to
Warner Chilcott Company, Inc. (“Warner”). Warner paid us $500,000
upon signing and agreed to pay us up to $12.5 million on the achievement of
specific regulatory milestones and to undertake the manufacturing investment and
any other investment for further product development that may be required for
product approval. Additionally, Warner was responsible for the
commercialization and manufacturing of Vitaros®.
On July
21, 2008, we received a not approvable action letter (the “Action Letter”) from
the FDA in response to our NDA. The major regulatory issues raised by
the FDA were related to the results of the transgenic (“TgAC”) mouse
carcinogenicity study which NexMed completed in 2002. The TgAC
concern raised by the FDA is product specific, and does not affect the
dermatological products in our pipeline, specifically NM100060.
On
October 15, 2008, we met with the FDA to discuss the major deficiencies cited in
the Action Letter and to reach consensus on the necessary actions for addressing
these deficiencies for our Vitaros®
NDA. Several key regulatory concerns were addressed and
agreements were reached at the meeting. The FDA agreed to: (a) a review by the
Carcinogenicity Advisory Committee (CAC) of the 2 two-year carcinogenicity
studies which were recently completed; (b) one Phase 1 study in healthy
volunteers to assess any transfer to the partner of the NexACT®
technology and (c) one animal study to assess the transmission of sexually
transmitted diseases with the design of the study to be
determined. The FDA also confirmed the revision on the status of our
manufacturing facility from “withhold” to “acceptable”, based on our having
adequately addressed the deficiencies cited in their Pre-Approval Inspection
(“PAI”) of our facility in January 2008. It is also our understanding
that at this time the FDA does not require a one-year open-label safety study
for regulatory approval. After the meeting we estimated that an
additional $4 to $5 million would be needed to be spent to complete the
abovementioned requirements prior to the resubmission of the NDA.
On
February 3, 2009, we announced the sale of the U.S. rights for Vitaros® and
the specific U.S. patents covering Vitaros® to
Warner which terminated the previous licensing agreement. Under
the terms of the agreement, we received gross proceeds of $2.5 million as an
up-front payment and are eligible to receive an additional payment of $2.5
million upon Warner’s receipt of an NDA approval from the FDA. In
addition, Warner will pay a total of $350,000 for the manufacturing equipment
for Vitaros®. The
purchase agreement with Warner gives us the right to reference their work on
Vitaros® in our
future filings outside the U.S. This is important as we move ahead
with international partnering opportunities because the additional data may
further validate the safety of the product and enhance its potential
value. While it is our understanding that Warner is currently moving
forward in pursuing NDA approval for Vitaros®, it is
not obligated by the purchase agreement to continue with the development of
Vitaros® and the
filing of the NDA.
18
On
February 21, 2007, the Canadian regulatory authority, Health Canada, informed us
that the lack of a completed 12-month open label safety study would not preclude
them from accepting and reviewing our New Drug Submission (“NDS”) in Canada,
which was accepted for review on February 15, 2008. On May 2, 2008,
we announced that our manufacturing facility received a GMP compliance
certification from Health Canada, which is essential for the ultimate approval
and marketing of Vitaros® in
Canada. We received a Letter of Deficiences (“LOD”) on November 12,
2008 which cited similar regulatory issues as previously cited by the
FDA. On February 18, 2009 we responded to the LOD but anticipate that
Health Canada will require further information from us before they can complete
their review and approval process. While we remain positive about the
prospects for approval in Canada, the risk remains that we may not be successful
in obtaining Health Canada approval of our product for marketing.
On April
20, 2007, the United Kingdom regulatory authority, Medicines and Healthcare
Products Regulatory Agency (the “MHRA”), also informed us that the safety data
that we have compiled to date was sufficient for the Marketing Authorization
Application (“MAA”) to be filed and accepted for review in the United
Kingdom. We had another guidance meeting with the MHRA in January
2008 and received additional input for the preparation of our
MAA. However, the MHRA has recently informed us that due to the
backlog of MAA filings, they would not be able to receive and start reviewing
our MAA until October 2010. Even though we are encouraged by the
initial positive feedback from the MHRA, the risk remains that we may not be
successful in obtaining MHRA and other European regulatory authorities approval
of our product for marketing.
Femprox® and
Other Products
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 was significantly lower
than in the U.S. We do not intend to conduct additional studies for
this product until we have secured a co-development partner, which we are
actively seeking.
We have
also continued early stage development work for our product pipeline with the
goal of focusing our attention on product opportunities that would replicate the
model of our licensed anti-fungal nail treatment. Our current efforts
are focused on the development of viable topical treatments for psoriasis, a
common dermatological condition.
19
Restructuring
Plans
In
December 2008, we began to implement a restructuring program with the goal of
reducing costs and outsourcing basic research and development. As
part of our restructuring plan, we announced on January 22, 2009 a memorandum of
understanding (“MOU”) with Pharmaceutics International, Inc. or
Pii. The purpose of this collaboration is to broaden the
promotion of our technology as well as permit us access to Pii’s research and
development and commercial manufacturing infrastructure. Pii is a privately-held
contract research and manufacturing organization with over 400 employees located
near Baltimore, Maryland. Their capabilities range from product
research and development to commercial manufacturing. Pursuant to our
MOU, Pii will promote our NexACT®
technology to its clients and may independently identify new product development
opportunities for this collaboration with NexMed. We will provide
technical guidance and oversight in the development of new
products. In addition, as part of our restructuring plan, we are
discussing with Pii the opportunity to co-develop our early stage products which
will enable us to further reduce our monthly overhead expenses.
The
partnership with Pii allows us to continue the development of our early stage
projects while we reduce our research and development staff and
infrastructure. As a result, our monthly operating overhead burn rate
has been reduced to approximately $300,000 per month. Access to Pii’s
state of the art facilities also allows us to further improve our cash position
by selling our facility and redundant equipment. We have initiated
efforts to sell our facility which, if successful, would further reduce our
monthly operating expenses to approximately $200,000 per month after the sale of
the facility is completed.
During
2009, we plan to work with Pii to complete the development of the psoriasis
project and then license the product to a co-development and marketing
partner. We also plan to license the rights to Vitaros®
for territories outside the U.S., including Canada, South America, and
Europe. The purchase agreement with Warner gives us the right to
reference their work on Vitaros® in our
future filings outside the U.S. This is important as we move ahead
with international partnering opportunities because the additional data may
further validate the safety of the product and enhance its potential
value. Additionally, the future work done by Warner regarding the
safety of Vitaros® may
enhance the value of Femprox® as
we work to find a marketing and co-development partner during
2009. In addition, we remain open to opportunities to co-develop
products utilizing our NexACT®
technology and we will be actively pursuing strategic opportunities that would
leverage our NexACT® platform
and generate partnership revenues to fund our development
efforts.
On April 14, 2009, we engaged FTN Equity Capital Markets
Corp. (“FTN”) as our financial advisor to assist us in exploring and evaluating
strategic alternatives. We are currently exploring and considering various
opportunities available to us, including merger or acquisition transactions with
the overall goal of enhancing value and maximizing the return on investment for
our shareholders. While we have engaged FTN to help us explore all
possible transactions for the Company, there can be no assurances that this
process will result in any specific transactions and no decision has been made
to pursue any specific strategic alternative at this time.
20
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, 2009, we had an accumulated deficit
of $139,004,528. 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,
2008 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, 2009 we had cash and cash
equivalents of approximately $3.8 million as compared to $2.9 million at
December 31, 2008. During the first quarter of 2009, we
received $2,675,000 from Warner from the sale of Vitaros® as
discussed above. The receipt of this cash in 2009 was offset by
our cash used in operations in the
first quarter of 2009. We spent approximately $1.8 million consisting
of our average fixed monthly overhead costs of approximately $350,000 per month
in addition to $300,000 towards a cancellation fee as discussed in Note 9 of the
Notes to Unaudited Consolidated Financial Statements. Additionally we spent approximately
$210,000 in severance and accrued vacation paid as part of our restructuring
program implemented in December 2008, $125,000 for the 2008 financial
statement audit fee, $28,000 for the Nasdaq annual listing fee,
$36,000 in legal fees related to the execution of the Warner asset purchase
agreement as discussed in Note 10 of the Notes to Unaudited Consolidated
Financial Statements and $39,000 for legal fees in connection
with a patent lawsuit in which we are the plaintiff suing for patent
infringement on our herpes treatment medical device.
Our
current cash reserves of approximately $3.4 million as of the date of this
report, along with the anticipated near term payments from Warner as discussed
in Note 10 of the Notes to Unaudited Consolidated Financial Statements, should
provide us with sufficient cash to fund our operations into the first quarter of
2010. This projection is based on the restructuring plan we
implemented in December 2008 whereby we have reduced our current monthly
operating expenditures to approximately $300,000 per month. In
addition, as part of our restructuring plan, we are discussing with Pii the
opportunity to co-develop our early stage products which will enable us to
further reduce our monthly overhead expenses and allow us to sell our facility
and redundant equipment. We have also initiated efforts to sell the facility
housing our corporate office, research and development laboratories and
manufacturing plant located in East Windsor, New Jersey. If we can
successfully sell our facility and repay the existing mortgage, we should be
able to reduce our monthly operating expenditures to approximately $200,000 per
month. However, there is no assurance that we will be able to sell
our facility at an acceptable price or otherwise successfully complete our
restructuring plan.
21
At March
31, 2009 we had an Other receivable of $175,000 as a result of the sale of
manufacturing equipment to Warner in February 2009, as discussed in Note 10 of
the Notes to Unaudited Consolidated Financial Statements.
At March
31, 2009, we had $727,252 in accounts payable and accrued expenses as compared
to $1,029,486 at December 31, 2008. The decrease is primarily
attributable to a $300,000 payment made during the first quarter of 2009 toward
approximately $592,000 that was included in accrued expenses at December 31,
2008 for a cancellation fee related to the cancellation of a clinical research
agreement for a one-year open-label study that will no longer be required by the
FDA for regulatory approval of Vitaros®, as
discussed in Note 10 of the Notes to Unaudited Consolidated Financial
Statements.
At March
31, 2009, we had $100,300 in deferred revenue as a result of the licensing of
our patents to Warner as part of the Asset Purchase Agreement signed in February
2009, as discussed in Note 10 of the Notes to Unaudited Consolidated Financial
Statements.
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 16, 2009.
Comparison
of Results of Operations Between the Three Months Ended March 31, 2009 and
2008.
Revenue, principally license fee
revenue. We recorded $2,466,670 in revenue during the first
quarter of 2009, as compared to $951,787 in revenue during the first quarter of
2008. The increase is attributable to the sale of the U.S. rights of
Vitaros® to
Warner as discussed in Note 9 of the Notes to Unaudited Consolidated Financial
Statements. The $951,787 of revenue in the first quarter of 2008
consisted of revenue recognized related to the $1.5 million milestone payment
received from Novartis on March 4, 2008 as discussed in Note 10 of the Notes to
Unaudited Consolidated Financial Statements.
22
Research and Development
Expenses. Our research and development expenses for the first
quarters of 2009 and 2008 were $602,366 and $1,169,091,
respectively. Research and development expenses in the first quarter
of 2009 decreased primarily due to reduced spending in 2009 on our development
programs as part of our restructuring program. During the first
quarter of 2009 we reduced our research and development staff and infrastructure
while maintaining our ability to continue the development of our early stage
projects by entering into a partnership with Pii as discussed
earlier. We plan to spend considerably less on research and
development in 2009 as we actively seek co-development partners for our early
stage products under development, including our topical treatment for
psoriasis.
General and Administrative
Expenses. Our general and administrative expenses were
$1,091,047 during the first quarter of 2009 as compared to $1,303,398 during the
same period in 2008. The decrease is primarily due to a reduction in
staff costs as a result of our restructuring program implemented in December
2008 along with a reduction in legal fees related to our patents as we expended
over $100,000 during the first quarter of 2008 for one-time national filings of
patent applications related to Vitaros®.
Interest Expense,
Net. We had net interest expense of $88,485 during the first
quarter of 2009, as compared to $121,485 during the same period in
2008. The decrease is primarily due to higher interest expense
recorded in 2008 as a result of the amortization of the debt discount related to
the existing debt during 2008 as discussed in Note 6 of the Notes to Unaudited
Consolidated Fnancial Statements. There was no such amortization of
debt discount during the same period in 2009.
Net Income
(Loss). The net income was $684,772 or $0.01 per share in the
first quarter of 2009 as compared to a net loss of ($1,642,187) or ($0.02) per
share in the same period in 2008. The increase in net income is
primarily attributable to the sale of the U.S. rights of Vitaros® to
Warner as discussed in Note 10 of the Notes to Unaudited Consolidated Financial
Statements. However, we anticipate a net loss for the year ended
December 31, 2009.
ITEM
3.
|
QUALITATIVE
AND QUANTITATIVE DISCLOSURES ABOUT MARKET
RISK
|
There have been no material changes to
our exposures to market risk since December 31,
2008.
23
ITEM
4. CONTROLS
AND PROCEDURES
In
accordance with Exchange Act Rules 13a-15 and 15d-15, the Company’s management, with
participation of the Company’s Chief Executive
Officer and Chief Financial Officer, its principal executive officer and
principal financial officer, respectively, carried out an evaluation 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 16, 2009.
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 16, 2009.
24
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.
|
25
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 11, 2009
|
/s/ Mark Westgate
|
Mark
Westgate
|
|
Vice
President and Chief Financial
|
|
Officer
|
26
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.
|
27