SEELOS THERAPEUTICS, INC. - Quarter Report: 2009 June (Form 10-Q)
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
DC 20549
FORM
10-Q
x
|
Quarterly
report pursuant to Section 13 or 15(d) of the Securities Exchange Act of
1934 for the quarterly period ended June 30,
2009.
|
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
¨
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 August 7, 2009,
88,991,339 shares of Common Stock, par value $0.001 per share, were
outstanding.
Table of
Contents
Page
|
|||
Part
I. FINANCIAL INFORMATION
|
3
|
||
Item
1.
|
Financial
Statements
|
3
|
|
Consolidated
Balance Sheets at June 30, 2009 (unaudited) and December 31,
2008
|
3
|
||
Unaudited
Consolidated Statements of Operations for the Three and Six Months Ended
June 30, 2009 and June 30, 2008
|
4
|
||
Unaudited
Consolidated Statements of Cash Flows for the Three and Six Months Ended
June 30, 2009 and June 30, 2008
|
5
|
||
Notes
to Unaudited Consolidated Financial Statements
|
6
|
||
Item
2.
|
Management's
Discussion and Analysis of Financial Condition and Results of
Operations
|
19
|
|
Item
3.
|
Quantitative
and Qualitative Disclosures about Market Risk
|
27
|
|
Item
4.
|
Controls
and Procedures
|
28
|
|
Part
II. OTHER INFORMATION
|
28
|
||
Item
1.
|
Legal
Proceedings
|
28
|
|
Item
1A.
|
Risk
Factors
|
28
|
|
Item
6.
|
Exhibits
|
29
|
|
|
|||
Signatures
|
30
|
||
|
|||
Exhibit
Index
|
31
|
2
PART
I. FINANCIAL INFORMATION
ITEM
1. FINANCIAL STATEMENTS
NexMed,
Inc.
Consolidated
Balance Sheets
June
30,
|
December
31,
|
|||||||
2009
|
2008
|
|||||||
(Unaudited)
|
||||||||
Assets
|
||||||||
Current
assets:
|
||||||||
Cash
and cash equivalents
|
$ | 2,811,315 | $ | 2,862,960 | ||||
Debt
issuance cost, net of accumulated amortization
|
||||||||
of
$42,283 - current portion
|
- | 30,368 | ||||||
Prepaid
expenses and other assets
|
149,558 | 83,761 | ||||||
Total
current assets
|
2,960,873 | 2,977,089 | ||||||
Fixed
assets, net
|
5,013,680 | 5,519,652 | ||||||
Debt
issuance cost, net of accumulated amortization
|
||||||||
of
$30,334 and $86,607
|
75,955 | 60,771 | ||||||
Total
assets
|
$ | 8,050,508 | $ | 8,557,512 | ||||
Liabilities, convertible preferred stock and
stockholders' equity
|
||||||||
Current
liabilities:
|
||||||||
Accounts
payable and accrued expenses
|
$ | 830,903 | $ | 1,029,486 | ||||
Payroll
related liabilities
|
63,413 | 296,135 | ||||||
Deferred
revenue - current portion
|
60,200 | - | ||||||
Deferred
compensation - current portion
|
65,421 | 74,245 | ||||||
Total
current liabilities
|
1,019,937 | 1,399,866 | ||||||
Long
Term liabilities:
|
||||||||
Convertible
notes payable
|
4,340,000 | 4,690,000 | ||||||
Deferred
revenue
|
87,550 | - | ||||||
Deferred
compensation
|
902,468 | 935,517 | ||||||
Total
Liabilities
|
6,349,955 | 7,025,383 | ||||||
Commitments
and contingencies (Note 10)
|
||||||||
Stockholders'
equity:
|
||||||||
Common
stock, $.001 par value, 120,000,000
|
||||||||
shares
authorized, 86,437,528 and 84,350,361
|
||||||||
and
outstanding, respectively
|
86,438 | 84,352 | ||||||
Additional
paid-in capital
|
142,044,801 | 141,137,077 | ||||||
Accumulated
deficit
|
(140,430,686 | ) | (139,689,300 | ) | ||||
Total
stockholders' equity
|
1,700,553 | 1,532,129 | ||||||
Total
liabilities and stockholder's equity
|
$ | 8,050,508 | $ | 8,557,512 |
See notes
to unaudited consolidated financial statements.
3
NexMed,
Inc.
Consolidated
Statements of Operations
(Unaudited)
FOR
THE THREE MONTHS
|
FOR
THE SIX MONTHS ENDED
|
|||||||||||||||
ENDED JUNE 30,
|
JUNE 30,
|
|||||||||||||||
2009
|
2008
|
2009
|
2008
|
|||||||||||||
Revenue
|
$ | 102,613 | $ | 1,199,612 | $ | 2,569,283 | $ | 2,151,399 | ||||||||
Operating
expenses
|
||||||||||||||||
Research
and development
|
716,453 | 1,096,402 | 1,318,819 | 2,265,493 | ||||||||||||
General
and administrative
|
694,749 | 1,193,379 | 1,785,796 | 2,496,777 | ||||||||||||
Total
operating expenses
|
1,411,202 | 2,289,781 | 3,104,615 | 4,762,270 | ||||||||||||
Loss
from operations
|
(1,308,589 | ) | (1,090,169 | ) | (535,332 | ) | (2,610,871 | ) | ||||||||
Interest
expense, net
|
(117,569 | ) | (538,554 | ) | (206,054 | ) | (660,039 | ) | ||||||||
Net
loss
|
(1,426,158 | ) | (1,628,723 | ) | (741,386 | ) | (3,270,910 | ) | ||||||||
Basic
and diluted loss per common share
|
$ | (0.02 | ) | $ | (0.02 | ) | $ | (0.01 | ) | $ | (0.04 | ) | ||||
Weighted
average common shares outstanding
|
||||||||||||||||
used
for basic and diluted loss per share
|
84,844,037 | 83,508,503 | 84,617,487 | 83,301,425 |
See notes
to unaudited consolidated financial statements.
4
NexMed,
Inc.
Consolidated
Statements of Cash Flows (Unaudited)
FOR
THE SIX MONTHS ENDED
|
||||||||
JUNE 30,
|
||||||||
2009
|
2008
|
|||||||
Cash
flows from operating activities
|
||||||||
Net
loss
|
$ | (741,386 | ) | $ | (3,270,910 | ) | ||
Adjustments
to reconcile net loss to net cash used in operating
|
||||||||
activities
|
||||||||
Depreciation
and amortization
|
201,767 | 248,393 | ||||||
Non-cash
interest, amortization of debt discount and
|
||||||||
deferred
financing costs
|
51,762 | 586,366 | ||||||
Non-cash
compensation expense
|
573,234 | 630,771 | ||||||
(Gain)
loss on disposal of fixed assets
|
(42,869 | ) | 2,605 | |||||
Increase
in prepaid expenses and other assets
|
(65,797 | ) | (73,721 | ) | ||||
Decrease
in accounts payable
|
||||||||
and
accrued expenses
|
(198,583 | ) | (22,869 | ) | ||||
Decrease
in payroll related liabilities
|
(232,722 | ) | (613,710 | ) | ||||
Decrease
in deferred compensation
|
(41,873 | ) | (30,067 | ) | ||||
Increase
in deferred revenue
|
147,750 | (647,973 | ) | |||||
Net
cash used in operating activities
|
(348,717 | ) | (3,191,115 | ) | ||||
Cash
flows from investing activities
|
||||||||
Capital
expenditures
|
(2,928 | ) | (17,742 | ) | ||||
Proceeds
from sale of fixed assets
|
350,000 | - | ||||||
Proceeds
from sale of marketable securities and short term
investments
|
- | 750,000 | ||||||
Net
cash provided by investing activities
|
347,072 | 732,258 | ||||||
Cash
flows from financing activities
|
||||||||
Proceeds
from exercise of stock options and warrants
|
- | 459,749 | ||||||
Repayment
of note payable
|
- | (3,000,000 | ) | |||||
Issuance
of convertible notes, net of debt issuance costs of
$105,804
|
5,644,196 | |||||||
Repayment
of convertible notes payable
|
(50,000 | ) | - | |||||
Net
cash (used in) provided by financing activities
|
(50,000 | ) | 3,103,945 | |||||
Net
increase (decrease) in cash and cash equivalents
|
(51,645 | ) | 645,088 | |||||
Cash
and cash equivalents, beginning of period
|
$ | 2,862,960 | $ | 2,735,940 | ||||
Cash
and cash equivalents, end of period
|
$ | 2,811,315 | $ | 3,381,028 | ||||
Supplemental
Information:
|
||||||||
Issuance
of common stock for repayment of convertible notes payable
|
$ | 300,000 | $ | - |
See notes
to unaudited consolidated financial statements.
5
NexMed,
Inc.
Notes
to Unaudited
Consolidated
Financial Statements
1.
|
BASIS
OF PRESENTATION
|
The
accompanying unaudited consolidated financial statements have been prepared in
accordance with accounting principles generally accepted in the United States of
America for interim financial information and with the instructions to Form 10-Q
and Article 10-01 of Regulation S-X. Accordingly, they do not include
all of the information and footnotes required by accounting principles generally
accepted in the United States of America for annual financial
statements. In the opinion of management, all adjustments (consisting
of normal recurring accruals) considered necessary for a fair statement have
been included. Operating results for the six months ended June 30,
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 $140,430,686 at June 30, 2009, and the
Company expects to incur additional losses during the remainder of
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.
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, March 23, 2009 and again on
July 13, 2009, we were notified by Nasdaq that it had suspended the enforcement
of the bid price requirement until August 3, 2009. As such,
since the Company had 174 days remaining in our compliance period, it now has
174 days from August 3, 2009, or until January 25, 2010, to regain
compliance with Marketplace Rule 4310(c)(8)(E).
6
If the
Company fails to achieve the minimum bid price requirement of the Nasdaq Capital
Market by January 25, 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.
On May
11, 2009, the Company demonstrated that it had achieved compliance with the
minimum $2.5 million in stockholders’ equity requirement as evidenced by the
Consolidated Balance Sheet contained in its March 31, 2009 Form 10Q that was
then filed. At that time Nasdaq indicated that it would continue to monitor the
Company’s ongoing compliance with the stockholder’s equity requirement should
the Company not maintain $2.5 million in stockholders’ equity through June 30,
2009. Per the Consolidated Balance Sheet contained in this report,
total stockholders’ equity was $1,700,553 at June 30, 2009, and as such, the
Company has not demonstrated compliance with the minimum $2.5 million
stockholders’ equity requirement. Therefore, the Company anticipates
receiving a delisting notice from Nasdaq. In the event that the
Company receives such notice, the Company does not currently have the resources
to regain compliance with continued listing on the Nasdaq Capital
Market. Should it be delisted from Nasdaq, its stock will begin
trading on the OTC Bulletin Board.
7
In May 2009, the Financial Accounting
Standards Board (“FASB”) issued SFAS No. 165, “Subsequent Events” (“SFAS No.
165”). SFAS No. 165 requires entities to disclose the date through which they
have evaluated subsequent events and whether the date corresponds with the
release of their financial statements. SFAS No. 165 is effective for the interim
period ending after June 15, 2009. The adoption of this SFAS No. 165 did not
have an impact on the Company’s consolidated results of operations and financial
condition. The Company evaluated all events that occurred after June 30, 2009 up
through August 10, 2009. During this period no material events came to the
Company’s attention.
In June
2009, the FASB issued SFAS No. 168, “The FASB Accounting Standards Codification
and the Hierarchy of Generally Accepted Accounting Principles” (“SFAS No. 168”).
SFAS No. 168 will become the single source of authoritative nongovernmental U.S.
generally accepted accounting principles (“GAAP”), superseding existing FASB,
American Institute of Certified Public Accountants (“AICPA”), Emerging Issues
Task Force (“EITF”), and related accounting literature. SFAS No. 168 reorganizes
the thousands of GAAP pronouncements into roughly 90 accounting topics and
displays them using a consistent structure. Also included is relevant Securities
and Exchange Commission guidance organized using the same topical structure in
separate sections. SFAS No. 168 will be effective for financial statements
issued for reporting periods that end after September 15, 2009. The adoption of
SFAS No. 168 is not expected to have a material impact on the Company’s
consolidated results of operations and financial condition.
In April
2009, the FASB issued FSP FAS No. 107-1 and Accounting Principles Board Opinion
28-1, “Interim Disclosures about Fair Value of Financial Instruments: (“APB
28-1”). APB 28-1 amends SFAS No. 107, “Fair Value of Financial Instruments” to
require disclosures about fair value of financial instruments for interim
reporting periods in addition to the required disclosures in annual financial
statements. APB 28-1 also amends APB Opinion 28, “Interim Financial Reporting”,
to require those disclosures in summarized financial information at interim
reporting periods. FSP FAS 107-1 and APB 28-1 are effective for interim
reporting periods ending after June 15, 2009. The adoption of FSP 107-1 and APB
28-1 did not have an impact on the Company’s financial statements.
2.
|
FAIR
VALUE MEASUREMENTS
|
The
Company measures fair value in accordance with Statement of Financial Accounting
Standards (“SFAS”) No. 157, “Fair Value Measurements”
(“SFAS No. 157”). SFAS No. 157 defines fair value, establishes a
framework and gives guidance regarding the methods used for measuring fair
value, and expands disclosures about fair value measurements. SFAS No. 157
clarifies that fair value is an exit price, representing the amount that would
be received to sell an asset or paid to transfer a liability in an orderly
transaction between market participants. As such, fair value is a market-based
measurement that should be determined based on assumptions that market
participants would use in pricing an asset or liability. As a basis for
considering such assumptions there exists a three-tier fair-value hierarchy,
which prioritizes the inputs used in measuring fair value as
follows:
•
|
Level
1 - unadjusted quoted prices in active markets for identical assets or
liabilities that the Company has the ability to access as of the
measurement date.
|
8
•
|
Level
2 - inputs other than quoted prices included within Level 1 that are
directly observable for the asset or liability or indirectly observable
through corroboration with observable market
data.
|
•
|
Level
3 - unobservable inputs for the asset or liability only used when there is
little, if any, market activity for the asset or liability at the
measurement date.
|
This
hierarchy requires the Company to use observable market data, when available,
and to minimize the use of unobservable inputs when determining fair
value.
The
Company’s recurring fair value measurements at June 30, 2009 are as
follows:
Fair Value as
of June 30,
2009
|
Quoted
Prices in
Active
Markets for
Identical
Assets
(Level 1)
|
Significant
other
Observable
Inputs
(Level 2)
|
Significant
Unobservable
Inputs
(Level 3)
|
|||||||||||||
Assets:
|
||||||||||||||||
Cash
equivalents
|
$ | 1,002,705 | $ | - | $ | 1,002,705 | $ | - |
3.
|
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 and six months ended June 30, 2009 and June 30, 2008
includes expense for all equity awards granted during the three and six months
ended June 30, 2009 and June 30, 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):
9
FOR
THE THREE MONTHS
|
FOR
THE SIX MONTHS ENDED
|
|||||||||||||||
ENDED JUNE 30,
|
JUNE 30,
|
|||||||||||||||
2009
|
2008
|
2009
|
2008
|
|||||||||||||
Research
and development
|
14,061 | 9,595 | 61,576 | 18,778 | ||||||||||||
General
and administrative
|
$ | 226,927 | $ | 291,206 | $ | 511,658 | $ | 583,893 | ||||||||
Stock-based
compensation expense
|
$ | 240,988 | $ | 300,801 | $ | 573,234 | $ | 602,671 |
The
stock-based compensation expense has not been tax-effected due to the recording
of a full valuation allowance against U.S. net deferred tax assets.
The
Company accounts for stock and stock options granted to non-employees on a fair
value basis in accordance with SFAS No. 123, "Accounting for Stock-Based
Compensation," and Emerging Issues Task Force Issue No. 96-18, "Accounting for
Equity Instruments That Are Issued to Other Than Employees for Acquiring, or in
Conjunction with Selling, Goods or Services." Any stock or stock options issued
to non-employees are recorded in the consolidated financial statements using the
fair value method and then amortized to expense over the applicable service
periods. As a result, the non-cash charge to operations for non-employee options
with vesting or other performance criteria is valued each reporting period based
upon changes in the fair value of Common Stock.
The fair
value of each stock option grant is estimated on the grant date using the
Black-Scholes option-pricing model with the following assumptions used for the
three and six month periods ended June 30, 2009 and June 30, 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.
10
Pre-Vesting Forfeitures.
Estimates of pre-vesting option forfeitures are based on Company experience. The
Company will adjust its estimate of forfeitures over the requisite service
period based on the extent to which actual forfeitures differ, or are expected
to differ, from such estimates. Changes in estimated forfeitures will be
recognized through a cumulative catch-up adjustment in the period of change and
will also impact the amount of compensation expense to be recognized in future
periods. The cumulative effect resulting from initially applying the provisions
of SFAS 123R to nonvested equity awards was not significant. The
Company’s current forfeiture rate is 6.41%.
Stock
Options and Restricted Stock
Presented
below is a summary of the status of Company stock options as of June 30, 2009,
and related transactions for the six month period then ended
(unaudited):
Options
Outstanding
|
Options
Exercisable
|
|||||||||||||||||||||||||
Weighted
Average
|
Aggregate
|
Aggregate
|
||||||||||||||||||||||||
Range
of
|
Number
|
Remaining
|
Weighted
Average
|
Intrinsic
|
Number
|
Weighted
Average
|
Intrinsic
|
|||||||||||||||||||
Exercise
Prices
|
Outstanding
|
Contractual
Life
|
Exercise
Price
|
Value
|
Exercisable
|
Exercise
Price
|
Value
|
|||||||||||||||||||
$
|
.55
- 1.85
|
2,558,090 |
6.23
years
|
$ | 0.82 | $ | - | 2,558,090 | $ | 0.82 | $ | - | ||||||||||||||
2.00
- 3.99
|
77,350 |
2.77
years
|
3.31 | - | 77,350 | 3.31 | - | |||||||||||||||||||
4.00
- 5.50
|
371,401 |
3.02
years
|
4.65 | - | 371,401 | 4.65 | - | |||||||||||||||||||
7.00
- 12.00
|
18,000 |
0.93
years
|
8.67 | - | 18,000 | 8.67 | - | |||||||||||||||||||
|
||||||||||||||||||||||||||
3,024,841 |
5.71
years
|
$ | 1.40 | $ | - | 3,024,841 | $ | 1.40 | $ | - |
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
|
(344,150 | ) | $ | 1.33 | $ | - | |||||||
Outstanding
at June 30, 2009
|
3,024,841 | $ | 1.40 |
5.71 years
|
$ | - | |||||||
Vested
or expected to vest at
|
|||||||||||||
June
30, 2009
|
3,024,841 | $ | 1.40 |
5.71 years
|
$ | - | |||||||
Exercisable
at June 30, 2009
|
3,024,841 | $ | 1.40 |
5.71 years
|
$ | - |
No
options were granted or exercised during the six months ended June 30,
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 six months ended
June 30, 2008 was $43,270. Cash received from option exercises for
the six months ended June 30, 2008 was $39,750.
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 six months ended June 30, 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.
11
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
Mr. Berman would have received for his service as Chairman of 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.
On June
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 third quarter 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
10,708 shares of Common Stock of which 3,569.33 shares vest on the 9th day of
each month from July through September 2009.
Also on
June 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
third quarter 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
Mr. Berman would have received for his service as Chairman of the Board, divided
by the Price. Therefore Mr. Berman received an award of 20,541 shares
of Common Stock of which 6,847 shares vest on the 9th day of
each month from July through September 2009.
Such
transactions resulted in compensation charges of $180,152 for the six months
ended June 30, 2009.
4.
|
WARRANTS
|
A summary
of warrant activity for the six month period ended June 30, 2009 is as
follows:
Weighted
|
Weighted
|
||||||||
Common
Shares
|
Average
|
Average
|
|||||||
Issuable
upon
|
Exercise
|
Contractual
|
|||||||
Exercise
|
Price
|
Life
|
|||||||
Outstanding
at December 31, 2008
|
12,118,044 | $ | 1.23 |
2.43
years
|
|||||
Issued
|
- | ||||||||
Exercised
|
- | ||||||||
Cancelled
|
(3,106,413 | ) | $ | 1.70 | |||||
Outstanding
at June 30, 2009
|
9,011,631 | $ | 1.07 |
1.29 years
|
|||||
Exercisable
at June 30, 2009
|
9,011,631 | $ | 1.07 |
1.29
years
|
5.
|
LOSS
PER SHARE
|
At June
30, 2009 and 2008, respectively, options to acquire 3,024,841 and 3,408,991
shares of Common Stock with exercise prices ranging from $0.55 to $12.00 per
share and warrants to acquire 9,011,631 and 12,118,044 shares of Common Stock
with exercise prices ranging from $0.55 to $3.00 and convertible securities
convertible into 2,170,000 and 2,946,429 shares of Common Stock at a weighted
average conversion price of $2.00 and $1.95, respectively, were excluded from
the calculation of diluted loss per share, as their effect would be
anti-dilutive. Loss per share for the three and six months ended June
30, 2009 and 2008 was calculated as follows (net loss / weighted average common
shares outstanding):
12
FOR
THE THREE MONTHS
|
FOR
THE SIX MONTHS ENDED
|
|||||||||||||||
ENDED JUNE 30,
|
JUNE 30,
|
|||||||||||||||
2009
|
2008
|
2009
|
2008
|
|||||||||||||
Net
loss
|
$ | (1,426,158 | ) | $ | (1,628,723 | ) | $ | (741,386 | ) | $ | (3,270,910 | ) | ||||
Weighted
average common shares outstanding
|
||||||||||||||||
used
for basic and diluted loss per share
|
84,844,037 | 83,508,503 | 84,617,487 | 83,301,425 | ||||||||||||
Basic
and diluted loss per common share
|
$ | (0.02 | ) | $ | (0.02 | ) | $ | (0.01 | ) | $ | (0.04 | ) |
6.
|
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 of the principal amount of the Convertible
Notes are due on December 31, 2011 (the “Due Date”) and $1 million of the
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. 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. Accordingly, on May 15, 2009, the
Company repaid $50,000 to the note holders upon the transfer of the
manufacturing equipment to Warner.
On May
27, 2009, the Company agreed to convert $150,000 of the outstanding Convertible
Notes to Common Stock at a price of $0.23 per share. As such, the
Company issued 659,402 shares of Common Stock to the note holders in repayment
of such $150,000 principal amount plus interest.
On June
11, 2009, the Company agreed to convert $150,000 of the outstanding Convertible
Notes to Common Stock at a price of $0.31 per share. As such, the
Company issued 490,645 shares of Common Stock to the note holders in repayment
of such $150,000 principal amount plus interest.
As a
result of the above mentioned Convertible Note repayments, the balance of
$4,340,000 is due on December 31, 2011 and is recorded as Convertible notes
payable on the Consolidated Balance Sheet at June 30, 2009.
On July
1, 2009, the Company paid $76,417 in cash for interest on the Note for the
period April 1, 2009 through June 30, 2009.
13
On July
23, 2009, the Company agreed to convert $300,000 of the outstanding Convertible
Notes to Common Stock at a price of $0.16 per share. As such, the
Company issued 1,883,385 shares of Common Stock to the note holders in repayment
of such $300,000 principal amount plus interest.
On July
29, 2009, the Company agreed to convert $100,000 of the outstanding Convertible
Notes to Common Stock at a price of $0.15 per share. As such, the
Company issued 670,426 shares of Common Stock to the note holders in repayment
of such $100,000 principal amount plus interest.
7.
|
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
six months ended June 30, 2008, the Company recorded $461,291 of amortization
related to the note discount.
8.
|
DEFERRED
COMPENSATION
|
On
February 27, 2002, the Company entered into an employment agreement with Y.
Joseph Mo, Ph.D., that had a constant term of five years, and pursuant to which
Dr. Mo would serve as the Company's Chief Executive Officer and
President. Under the employment agreement, Dr. Mo was entitled to
deferred compensation in an annual amount equal to one sixth of the sum of his
base salary and bonus for the 36 calendar months preceding the date on which the
deferred compensation payments commenced subject to certain limitations,
including annual vesting through January 1, 2007, as set forth in the employment
agreement. The deferred compensation is payable monthly for 180
months commencing on termination of employment. Dr. Mo’s employment
was terminated as of December 15, 2005. At such date, the Company
accrued deferred compensation of $1,178,197 based upon the estimated present
value of the obligation. The monthly deferred compensation payment
through May 15, 2021 is $9,158. As of June 30, 2009, the Company has
accrued $967,889 in deferred compensation.
14
9.
|
INCOME
TAXES
|
In
consideration of the Company’s accumulated losses and lack of historical ability
to generate taxable income, the Company has determined that it will not be able
to realize any benefit from its temporary differences between book 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.
10.
|
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 each of
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
June 30, 2009. The balance of approximately $292,000 was paid on July
7, 2009.
15
11.
|
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 upfront 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”).
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 six months ended June 30, 2008, the Company recognized
licensing revenue of $333,334 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 has paid the
Company 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, $4,250 is being recognized as revenue for
the three months ended June 30, 2009. The balance of $97,750 is
recorded as deferred revenue on the Consolidated Balance Sheet at June 30,
2009.
The
Company recognized a gain during the six months ended June 30, 2009 of $43,840
on the sale of the manufacturing equipment to Warner.
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. For the three and six months
ended June 30, 2009, the Company recorded $100,000 in license fee revenue for
the fees received in May and June. The Company also received the
$50,000 fee for July on June 29, 2009 and has recorded such amount as deferred
revenue on the Consolidated Balance Sheet at June 30, 2009.
16
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 was eligible to receive royalties
based upon the level of sales achieved and to receive reimbursements of third
party preclinical study costs up to $3.25 million. The Company
began recognizing the initial upfront 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 was no longer
obligated to complete the remaining preclinical studies for
NM100060. Novartis took over all responsibilities and completed
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 six months ended June 30, 2008, the Company recognized
licensing revenue of $564,639 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.
17
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.
In July
2009, Novartis completed final analysis of the comparator study which they had
initiated in March 2007 in ten European countries. The study results
were insufficient to support marketing approval in Europe. As such,
on July 8, 2009, the Company announced the mutual decision reached with Novartis
to terminate the licensing agreement. Accordingly, pursuant to the
Termination Agreement, Novartis will provide to the Company reports associated
with the Phase III clinical trials conducted for NM100060 within 30 days of the
Company’s request, and provide assistance and support to the Company in
connection with the assignment, transfer and delivery to the Company of all
know-how and data relating to NM100060 in accordance with the terms of the
License Agreement.
In
consideration of such assistance and support, the Company will pay to Novartis
15% of any upfront and/or milestone payments that it receives from any future
third party licensee of NM100060, as well as a royalty fee ranging from 2.8% to
6.5% of annual net sales of products developed from NM100060 (collectively,
“Products”), with such royalty fee varying based on volume of such annual net
sales. In the event that the Company, or a substantial part of its
assets, is sold, the Company will pay to Novartis 15% of any upfront and/or
milestone payments received by the Company or its successor relating to the
Products, as well as a royalty fee ranging from 3% to 6.5% of annual net sales
of any Products, with such royalty fee varying based on volume of such annual
net sales. If the acquirer makes no upfront or milestone payments,
the royalty fees payable to Novartis will range from 4% to 6.5% of annual net
sales of any Products.
18
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
are actively seeking co-development partners for topical treatments for male and
female sexual dysfunction, nail fungus, psoriasis, and other dermatological
conditions that are in various stages of development We intend to
continue our efforts developing topical treatments on our own or through
development partnerships 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.
19
NM100060
Anti-Fungal Treatment
We had 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 had 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 were 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.
20
In July
2009, Novartis completed final analysis of the comparator study which they had
initiated in March 2007 in ten European countries. The study results
were insufficient to support marketing approval in Europe. As such,
on July 8, 2009, we announced the mutual decision reached with Novartis to
terminate the licensing agreement. In accordance with the terms of
the termination agreement, Novartis has provided us with all of the requested
reports to date for the three Phase 3 studies that they conducted for NM100060
and is assisting and supporting us in connection with the assignment, transfer
and delivery to us of all know-how and data relating to the
product.
In
consideration of such assistance and support, we will pay to Novartis 15% of any
upfront and/or milestone payments that we receive from any future third party
licensee of NM100060, as well as a royalty fee ranging from 2.8% to 6.5% of
annual net sales of products developed from NM100060 (collectively, “Products”),
with such royalty fee varying based on volume of such annual net
sales. In the event that the Company, or a substantial part of our
assets, is sold, we will pay to Novartis 15% of any upfront and/or milestone
payments received by us or our successor relating to the Products, as well as a
royalty fee ranging from 3% to 6.5% of annual net sales of any Products, with
such royalty fee varying based on volume of such annual net sales. If
the acquirer makes no upfront or milestone payments, the royalty fees payable to
Novartis will range from 4% to 6.5% of annual net sales of any
Products.
We have begun to analyze the data from
the three studies completed by Novartis. The results from the three
studies were consistent, and we believe showed comparable safety and efficacy
profiles of NM100060 with the currently marketed topical prescription products
in patients with mild to moderate toenail fungus. In the post hoc
analysis of patients with mild fungus, our product seems to show higher
efficacy. Upon completion of our analysis, we intend to proceed with
potential new licensing discussions. We have already received
inquiries from companies with a focus in dermatology who are interested in
possibly licensing the product for the U.S. market.
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®.
21
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 above
mentioned 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
upfront 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 has paid us 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 Warner is not obligated by the purchase
agreement to continue with the development of Vitaros® and the
filing of the NDA, as of the date of this report, Warner is in the process of
completing the CAC assessment package for submission to the FDA for
review and has informed us that should the outcome of the FDA review be
positive, it intends to proceed with the required Phase 1 study which the FDA
mandated at the October 2008 meeting.
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 Notice of Deficiencies (“NOD”) on November 12,
2008 which cited similar regulatory issues to those previously cited
by the FDA. On February 18, 2009 we responded to the NOD and have
continued to respond to requests by Health Canada for further information as
they continue 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.
22
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
Our
product pipeline also includes 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 previously licensed anti-fungal nail treatment. Our
current efforts are focused on the development of viable topical treatments for
psoriasis, a common dermatological condition.
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 would provide technical
guidance and oversight in the development of new products.
23
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.
Liquidity,
Capital Resources and Financial Condition.
We have
experienced net losses and negative cash flows from operations each year since
our inception. Through June 30, 2009, we had an accumulated deficit
of $140,430,686. 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 June
30, 2009 we had cash and cash equivalents of approximately $2.8 million as
compared to $2.9 million at December 31, 2008. During the first
six months of 2009, we received $3,000,000 from Warner from the sale of the U.S.
rights to Vitaros® and the
related facility license fees as discussed above. The receipt of this
cash in 2009 was offset by our cash used in operations in the first six months
of 2009. We spent approximately $3.1 million consisting of our
average fixed monthly overhead costs of approximately $325,000 per month in
addition to $300,000 towards a cancellation fee as discussed in Note 10 of the
Notes to Unaudited Consolidated Financial Statements. Additionally we
spent approximately $276,475 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, $50,000 of principal on convertible notes repaid as discussed in Note 5 of
the Notes to Unaudited Consolidated Financial Statements, $50,000 in investment
banker fees to FTN for advisory services to assist us in exploring
and evaluating strategic alternatives, $42,000 in legal fees and $175,000 in
consulting fees related to the execution of the Warner Asset Purchase Agreement
as discussed in Note 11 of the Notes to Unaudited Consolidated Financial
Statements and $46,000 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.
24
Our
current cash reserves of approximately $2.2 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 operating
expenditures to approximately $300,000 per month. We have also
initiated efforts to lease or 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 which would then provide us
with additional cash to fund our operations. 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.
At June
30, 2009, we had $147,750 in deferred revenue as a result of the licensing of
our patents to Warner along with the use of our facility in connection with the
Asset Purchase Agreement, as amended, as discussed in Note 11 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 June 30, 2009 and
2008.
Revenue. We
recorded $102,613 in revenue during the second quarter of 2009, as compared to
$1,199,612 in revenue during the second quarter of 2008. The
decrease in revenue is primarily due to the $750,000 in revenue recognized
related to the $1.5 million milestone payment received from Novartis on March 4,
2008 as discussed in Note 11 of the Consolidated Financial
Statements. Additionally, the increased revenue in 2008 is the result
of the $166,667 in revenue recognized in 2008 attributable to the up-front
payment received in November 2007 from Warner as discussed in Note 11 of the
Consolidated Financial Statements. The 2009 revenue consists of
facility license fees for the use of our manufacturing facility and related
manufacturing know-how related to the sale of the U.S. rights of Vitaros® to
Warner as discussed in Note 11 of the Notes to Unaudited Consolidated Financial
Statements.
25
Research and Development
Expenses. Our research and development expenses for the second
quarter of 2009 and 2008 were $716,453 and $1,096,402,
respectively. While 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, we continued to incur research and development expenses during the
second quarter of 2009. During the quarter we had severance cost as a
result of the reduction of research and development personnel as part of our
restructuring program. Prior to the reduction in research and
development personnel, we incurred costs as we transferred early stage product
technology to Pii. For the remainder of 2009 we expect to continue
incurring costs related to the support of our regulatory filing in Canada,
continued support of Warner in their manufacturing efforts while at our
facility, and further analysis of the clinical data derived from the Phase 3
clinical trial program completed by Novartis for NM100060.
General and Administrative
Expenses. Our general and administrative expenses were
$694,749 during the second quarter of 2009 as compared to $1,193,379 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.
Interest Expense,
Net. We had net interest expense of $117,569 during the second
quarter of 2009, as compared to $583,554 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 7 of the Notes to Unaudited
Consolidated Financial Statements. There was no such amortization of
debt discount during the same period in 2009.
Net Loss. The net
loss was $1,426,158 or $0.02 per share and $1,628,723 or $0.02 per share in the
second quarter of 2009 and 2008, respectively. The decrease in net
loss is primarily attributable to a reduction in overall expenses as part of our
restructuring program implemented in December 2008 which has been partially
offset by a decrease in revenue during the second quarter of 2009 as discussed
above.
Comparison
of Results of Operations Between the Six Months Ended June 30, 2009 and
2008.
Revenue. We
recorded $2,569,283 in revenue during the first six months of 2009, as compared
to $2,151,399 in revenue during the same period in 2008. The increase
is attributable to the sale to Warner of the U.S. rights to Vitaros® as
discussed in Note 11 of the Notes to Unaudited Consolidated Financial
Statements. The $2,151,399 of revenue in the first half of 2008
consisted of revenue recognized related to the $1.5 million milestone payment
received from Novartis on March 4, 2008 and the up-front payment received from
Warner in 2007 as discussed in Note 11 of the Notes to Unaudited Consolidated
Financial Statements.
26
Research and Development
Expenses. Our research and development expenses for the first
half of 2009 and 2008 were $1,318,819 and $2,265,493,
respectively. Research and development expenses in the first half of
2009 decreased primarily due to reduced spending in 2009 on our development
programs as part of our restructuring program. During the first half
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
$1,785,796 during the first half of 2009 as compared to $2,496,777 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 half of 2008 for one-time national filings of
patent applications related to Vitaros®.
Interest Expense,
Net. We had net interest expense of $206,054 during the first
half of 2009, as compared to $660,039 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 7 of the Notes to Unaudited
Consolidated Financial Statements. There was no such amortization of
debt discount during the same period in 2009.
Net Loss. The net
loss was $741,386 or $0.01 per share in the first half of 2009 as compared to
$3,270,910 or $0.04 per share in the same period in 2008. The
significant decrease in net loss is primarily attributable to the income
recognized from the sale to Warner of the U.S. rights to Vitaros® as
discussed in Note 11 of the Notes to Unaudited Consolidated Financial Statements
along with our reduction in overall expenses as part of our restructuring
program implemented in December 2008.
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.
27
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 except for the following:
Without
a development partner for our principal product, we may not be able to sustain
our business operations going forward.
Our
principal product under development, NM100060, has not met Novartis’ expectation
for filing a New Drug Application in the U.S. or a Marketing Authorization
Application in Europe, and Novartis has terminated its global licensing
agreement with us. If we are to derive
revenue from NM100060 in the future, we will need to find a new development
partner to further develop, obtain regulatory approval and market
NM100060. While we are actively seeking such a partner, there is no
assurance that, in light of the determinations made by Novartis, we will be able
to find a partner.
28
ITEM
6.
|
EXHIBITS
|
10.1
|
Termination
Agreement, dated July 7, 2009, by and between NexMed, Inc., NexMed
International Limited and Novartis International Pharmaceutical
Ltd.
|
|
31.1
|
Chief
Executive Officer’s Certificate, pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002.
|
|
31.2
|
Chief
Financial Officer’s Certificate, pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002.
|
|
32.1
|
Chief
Executive Officer’s Certificate, pursuant to 18 U.S.C. Section 1350, as
adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 –
furnished only.
|
|
32.2
|
Chief
Financial Officer’s Certificate, pursuant to 18 U.S.C. Section 1350, as
adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 –
furnished
only.
|
29
SIGNATURES
In accordance with the requirements of
the Securities Exchange Act of 1934, the registrant caused this report to be
signed on its behalf by the undersigned, thereunto duly authorized.
NEXMED,
INC.
|
|
Date:
August 10, 2009
|
/s/ Mark Westgate
|
Mark
Westgate
|
|
Vice
President and Chief Financial
|
|
Officer
|
30
EXHIBIT
INDEX
10.1
|
Termination
Agreement, dated July 7, 2009, by and between NexMed, Inc., NexMed
International Limited and Novartis International Pharmaceutical
Ltd.
|
|
31.1
|
Chief
Executive Officer’s Certificate, pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002.
|
|
31.2
|
Chief
Financial Officer’s Certificate, pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002.
|
|
32.1
|
Chief
Executive Officer’s Certificate, pursuant to 18 U.S.C. Section 1350, as
adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 –
furnished only.
|
|
32.2
|
Chief
Financial Officer’s Certificate, pursuant to 18 U.S.C. Section 1350, as
adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 –
furnished
only.
|
31