SEELOS THERAPEUTICS, INC. - Quarter Report: 2010 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,
2010.
|
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.)
|
6330 Nancy Ridge Drive, Suite 103, San Diego, CA
92121
|
(Address
of Principal Executive
Offices)
|
(858) 222-8041
|
(Issuer’s
Telephone Number, Including Area
Code)
|
Indicate by check mark whether the
registrant: (1) has filed all reports required to be filed by Section
13 or 15 (d) of the Exchange Act during the preceding 12 months (or for such
shorter period that the registrant was required to file such reports), and (2)
has been subject to such filing requirements for the past 90 days.
Yes x No o
Indicate by check mark whether the
registrant 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).
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 o Accelerated
filer o Non-accelerated
filer o (do not check if a
smaller reporting company) Smaller reporting company x
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act). Yes o No
x
Indicate
the number of shares outstanding of each of the issuer’s classes of common
equity, as of the latest practicable date: as of May 12, 2010,
132,174,024 shares of Common Stock, par value $0.001 per share, were
outstanding.
Table of
Contents
|
Page
|
|
Part
I. FINANCIAL INFORMATION
|
||
Item
1.
|
Financial
Statements
|
1
|
Consolidated
Balance Sheets at March 31, 2010 (unaudited) and December 31,
2009
|
1
|
|
Unaudited
Consolidated Statements of Operations for the Three Months Ended March 31,
2010 and March 31, 2009
|
2
|
|
Unaudited
Consolidated Statements of Cash Flows for the Three Months Ended March 31,
2010 and March 31, 2009
|
3
|
|
Notes
to Unaudited Consolidated Financial Statements
|
4
|
|
Item
2.
|
Management's
Discussion and Analysis of Financial Condition and Results of
Operations
|
23
|
Item
3.
|
Quantitative
and Qualitative Disclosures about Market Risk
|
32
|
Item
4T.
|
Controls
and Procedures
|
32
|
Part
II. OTHER INFORMATION
|
||
Item
1.
|
Legal
Proceedings
|
33
|
Item
1A.
|
Risk
Factors
|
33
|
Item
6.
|
Exhibits
|
33
|
Signatures
|
34
|
|
Exhibit
Index
|
35
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PART
I. FINANCIAL INFORMATION
ITEM 1. FINANCIAL
STATEMENTS
NexMed,
Inc.
|
||||||||
Consolidated
Balance Sheets
|
||||||||
March
31,
|
December
31,
|
|||||||
2010
|
2009
|
|||||||
(Unaudited)
|
||||||||
Assets
|
||||||||
Current
assets:
|
||||||||
Cash
and cash equivalents
|
$ | 2,546,720 | $ | 479,888 | ||||
Accounts
receivable
|
583,608 | 708,898 | ||||||
Other
receivable
|
- | 437,794 | ||||||
Prepaid
expenses and other assets
|
141,563 | 140,521 | ||||||
Total
current assets
|
3,271,891 | 1,767,101 | ||||||
Fixed
assets, net
|
5,535,575 | 5,616,811 | ||||||
Goodwill
|
9,084,476 | 9,084,476 | ||||||
Restricted
cash
|
250,000 | - | ||||||
Intangible
assets, net of accumulated amortization
|
4,055,044 | 4,145,006 | ||||||
Due
from related party
|
- | 204,896 | ||||||
Debt
issuance cost, net of accumulated amortization of $1,432 and
$169,304
|
94,509 | 115,047 | ||||||
Total
assets
|
$ | 22,291,495 | $ | 20,933,337 | ||||
Liabilities and stockholders'
equity
|
||||||||
Current
liabilities:
|
||||||||
Notes
payable - former Bio-Quant shareholders
|
$ | 9,898,809 | $ | 12,129,010 | ||||
Accounts
payable and accrued expenses
|
1,776,031 | 1,453,621 | ||||||
Payroll
related liabilities
|
73,890 | 279,960 | ||||||
Deferred
revenue - current portion
|
166,420 | 118,115 | ||||||
Capital
lease payable - current portion
|
25,023 | 24,530 | ||||||
Due
to related parties
|
- | 99,682 | ||||||
Deferred
compensation - current portion
|
68,000 | 70,000 | ||||||
Total
current liabilities
|
12,008,173 | 14,174,918 | ||||||
Long
Term liabilities:
|
||||||||
Convertible
notes payable
|
4,000,000 | 2,990,000 | ||||||
Deferred
revenue
|
79,900 | 82,450 | ||||||
Capital
lease payable
|
108,131 | 114,965 | ||||||
Deferred
compensation
|
856,668 | 865,602 | ||||||
Total
Liabilities
|
17,052,872
|
18,227,935 | ||||||
Commitments
and contingencies (Note 14)
|
||||||||
Stockholders'
equity:
|
||||||||
Common
stock, $.001 par value, 270,000,000 and 120,000,000
|
||||||||
shares
authorized, 127,033,001 and 104,821,571
|
||||||||
and
outstanding, respectively
|
127,033 | 104,822 | ||||||
Additional
paid-in capital
|
186,080,908 | 174,332,442 | ||||||
Accumulated
deficit
|
(180,969,318 | ) | (171,731,862 | ) | ||||
Total
stockholders' equity
|
5,238,623 | 2,705,402 | ||||||
Total
liabilities and stockholder's equity
|
$ | 22,291,495 | $ | 20,933,337 | ||||
See
notes to unaudited consolidated financial statements.
|
1
NexMed,
Inc.
|
|||
Consolidated
Statements of Operations
(Unaudited)
|
FOR
THE THREE MONTHS
|
||||||||
ENDED
MARCH 31,
|
||||||||
2010
|
2009
|
|||||||
License
fee revenue
|
$ | 2,550 | $ | 2,466,670 | ||||
Contract
service revenue
|
1,443,202 | - | ||||||
Total
revenue
|
1,445,752 | 2,466,670 | ||||||
Cost
of services
|
1,037,232 | - | ||||||
Gross
profit
|
408,520 | 2,466,670 | ||||||
Costs
and expenses
|
||||||||
Research
and development
|
426,393 | 602,366 | ||||||
General
and administrative
|
2,239,536 | 1,091,047 | ||||||
Total
costs and expenses
|
2,665,929 | 1,693,413 | ||||||
Income
(loss) from operations
|
(2,257,409 | ) | 773,257 | |||||
Interest
expense, net
|
(6,980,047 | ) | (88,485 | ) | ||||
Net
income (loss)
|
$ | (9,237,456 | ) | $ | 684,772 | |||
Basic
and diluted income (loss) per common share
|
$ | (0.08 | ) | $ | 0.01 | |||
Weighted
average common shares outstanding
|
||||||||
used
for basic and diluted income (loss) per share
|
110,682,705 | 84,388,421 | ||||||
See
notes to unaudited consolidated financial statements.
|
2
NexMed,
Inc.
|
|||||||
Consolidated
Statements of Cash Flows
(Unaudited)
|
FOR
THE THREE MONTHS ENDED
|
||||||||
MARCH
31,
|
||||||||
2010
|
2009
|
|||||||
Cash
flows from operating activities
|
||||||||
Net
income (loss)
|
$ | (9,237,456 | ) | $ | 684,772 | |||
Adjustments
to reconcile net income (loss) to net cash provided by
|
||||||||
(used
in) operating activities
|
||||||||
Depreciation
and amortization
|
252,290 | 108,882 | ||||||
Non-cash
interest, amortization of beneficial conversion feature
and
|
||||||||
deferred
financing costs
|
6,838,943 | 7,592 | ||||||
Non-cash
compensation expense
|
144,553 | 332,246 | ||||||
(Gain)
loss on disposal of fixed assets
|
312 | (43,840 | ) | |||||
Changes in operating
assets and liabilities
|
||||||||
Increase
in prepaid expenses and other assets
|
(1,042 | ) | (7,362 | ) | ||||
Decrease
in accounts receivable
|
125,290 | - | ||||||
Decrease
in other receivable
|
437,794 | - | ||||||
Decrease
in due from related party
|
204,896 | |||||||
Increase
(decrease) in accounts payable
|
||||||||
and
accrued expenses
|
322,410 | (302,234 | ) | |||||
Decrease
in payroll related liabilities
|
(230,600 | ) | (134,256 | ) | ||||
Decrease
in due to related party
|
(99,682 | ) | - | |||||
Decrease
in deferred compensation
|
(10,934 | ) | (26,016 | ) | ||||
Increase
in deferred revenue
|
45,755 | 100,300 | ||||||
Net
cash (used in) provided by operating activities
|
(1,207,471 | ) | 720,084 | |||||
Cash
flows from investing activities
|
||||||||
Proceeds
from sale of fixed assets
|
1,142 | 175,000 | ||||||
Capital
expenditures
|
(82,545 | ) | - | |||||
Net
cash (used in) provided by investing activities
|
(81,403 | ) | 175,000 | |||||
Cash
flows from financing activities
|
||||||||
Proceeds
from issuance of notes payable
|
2,300,000 | - | ||||||
Proceeds
from issuance of convertible notes payable, net of debt issue
costs
|
3,904,059 | - | ||||||
Repayment
of convertible notes payable
|
(2,592,012 | ) | - | |||||
Repayment
of capital lease obligations
|
(6,341 | ) | - | |||||
Net
cash provided by financing activities
|
3,605,706 | - | ||||||
Net
increase in cash and cash equivalents
|
2,316,832 | 895,084 | ||||||
Cash
and cash equivalents, beginning of period
|
$ | 479,888 | $ | 2,862,960 | ||||
Cash
and cash equivalents, end of period
|
$ | 2,796,720 | $ | 3,758,044 | ||||
Supplemental
Information:
|
||||||||
Issuance
of common stock in payment of convertible notes payable
|
$ | 397,988 | $ | - | ||||
Issuance
of common stock in payment of notes payable
|
$ | 4,530,200 | $ | - | ||||
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
NexMed,
Inc. (the “Company”) was incorporated in Nevada in 1987. The Company
has historically focused its efforts on drug development using its patented drug
delivery technology known as NexACT® –
see Note 13 for a description of licensing agreements relating to the Company’s
proprietary products.
On
December 14, 2009, the merger (the “Merger”) contemplated by the Agreement and
Plan of Merger (the “Merger Agreement”) dated November 20, 2009 by and among the
Company and BQ Acquisition Corp., a wholly-owned subsidiary of the Company
(“Merger Sub”) with Bio-Quant, Inc. (“Bio-Quant”), was
completed. Accordingly, the results of operations of the
acquired company have been included in the consolidated results of operations of
the Company from December 14, 2009, the date of the Merger. Bio-Quant
is one of the largest specialty biotechnology contract research
organizations (“CROs”) based in San Diego, California and is one of the
industry's most experienced CROs for non-GLP (good laboratory practices) in
vitro and in vivo contract drug discovery and pre-clinical development services,
specializing in oncology, inflammation, immunology, and metabolic diseases.
Bio-Quant has over 300 clients world-wide and performs hundreds of studies a
year both in in vitro and in vivo pharmacology, pharmacokinetics (PK) and
toxicology to support pre-regulatory filing packages.
The
Company is currently focusing its efforts on new and patented pharmaceutical
products based on NexACT® and on
growing the newly acquired CRO business through organic growth within
Bio-Quant’s current business operations and through acquiring small cash flow
positive entities that have complementary capabilities to those of Bio-Quant,
but are not operating at full capacity due to insufficient business development
efforts. The Company believes this strategy will allow Bio-Quant to expand
its operations by broadening its service capabilities and going into new
markets.
The
Company’s long-term goal is to generate revenues from the growth of its CRO
business while aggressively seeking to monetize the NexACT®
technology through out-licensing agreements with pharmaceutical and
biotechnology companies worldwide. At the same time, the Company is
actively pursuing partnering opportunities for its clinical stage NexACT® based
treatments in the areas of dermatology and sexual dysfunction as discussed
below. The
successful licensing of one or more of these products would be expected to
generate additional revenues for funding the Company’s long-term growth
strategy.
Following
the acquisition of Bio-Quant, the Company operates in two segments – designing
and developing pharmaceutical products and providing pre-clinical CRO services
through its subsidiary, Bio-Quant.
4
Liquidity
The
accompanying consolidated financial statements have been prepared on a basis
which contemplates the realization of assets and the satisfaction of liabilities
and commitments in the normal course of business. The Company has an
accumulated deficit of $180,969,318 at March 31, 2010 and expects that it will
incur additional losses in the future relating to research and development
activities and integration of the operations of Bio-Quant into its
strategies. Further, the Company has substantial notes payable due
within 12 months, which if not converted to common stock or re-financed, would
significantly impact liquidity. These circumstances raise substantial
doubt about the Company's ability to continue as a going
concern. Management anticipates that the Company will require
additional financing, which it is actively pursuing, to fund operations,
including continued research and development of the Company’s NexACT technology,
integration of the Bio-Quant CRO business, and to fund potential future
acquisitions. Although management continues to pursue these plans,
there is no assurance that the Company will be successful in obtaining financing
on terms acceptable to the Company. See Notes 7, 8 and 16 for
descriptions of funds raised during 2010 through the date of this
report. If the Company is unable to obtain additional financing,
operations will need to be reduced or discontinued. The financial
statements do not include any adjustments that might result from the outcome of
this uncertainty.
New
Pronouncements
In April
2010, an accounting standard update was issued by the Financial Accounting
Standards Board to provide guidance on defining a milestone and determining
when it is appropriate to apply the milestone method of revenue recognition for
research and development transactions. Vendors can recognize consideration
that is contingent upon achievement of a milestone in its entirety as revenue in
the period the milestone is achieved if the milestone meets all the criteria
stated in the guidance to be considered substantive and must be considered
substantive in its entirety. The amendments in this update will be effective
prospectively for milestones achieved in fiscal years and interim periods
beginning on or after June 15, 2010, with early adoption permitted.
The Company does not expect this standard to have a material impact on its
financial statements.
2. ACQUISITION
On
December 14, 2009, the Company entered into the Merger Agreement with Bio-Quant.
Pursuant to the Merger Agreement, at the effective time of the Merger (the
“Effective Time”), each outstanding share of common stock, par value $0.01 per
share, of Bio-Quant was canceled and converted into the right to receive 913.96
shares of common stock, par value $0.001 per share, of the Company (the “NexMed
Shares”), as well as a promissory note (each, a “Note”) in the original
principal amount of $2,771.37. In connection with the closing
of the Merger, the Company issued an aggregate of 4,000,000 NexMed Shares and
Notes in the aggregate original principal amount of $12,129,010 to the
shareholders of Bio-Quant.
5
The Notes
bear interest at a rate of 10% per annum, with all principal and interest
accrued thereunder becoming due and payable one year from the closing date of
the Merger. The terms of the Notes provide that the principal amounts
and all interest thereunder are payable by the Company in cash or, at the
Company’s option, in NexMed Shares, which shall be valued at the fixed price of
$0.168 per share. The Merger Agreement provides that if the Company
repays the Notes in NexMed Shares, the total number of NexMed Shares issuable to
Bio-Quant shareholders shall not exceed 19.99% of outstanding NexMed Shares at
the Effective Time unless the Company receives stockholder approval to do so;
the Company is seeking stockholder approval at its May 24, 2010 meeting for the
potential issuance of shares in repayment of the remaining amounts owed under
the Notes.
The
acquisition was accounted for under the purchase method of accounting under FASB
ASC 805 Business
Combinations. The Company has determined that it is the “accounting
acquirer” in this transaction, as it meets the predominance of the factors
outlined in FASB ASC 805. Accordingly, the results of operations of
the acquired company have been included in the consolidated results of
operations of the Company from the date of the Merger.
The total
consideration was estimated to be approximately $13.7 million as of December 14,
2009, the date the Merger was consummated, as follows (in
thousands):
Fair
value of 4,000,000 shares of common stock issued for Bio-Quant common
stock (1)
|
$ | 1,600 | ||
Fair
value of promissory notes issued for Bio-Quant common
stock
|
12,129 | |||
Total
consideration
|
$ | 13,729 |
(1) The
fair value of the shares of NexMed common stock issued was based on the closing
price of the Company’s common stock on December 14, 2009, the date the Merger
was consummated, or $0.40 per share.
The
purchase price was allocated based on the estimated fair value of the tangible
and identifiable intangible assets acquired and liabilities assumed in the
Merger. An allocation of the purchase price was made to major categories of
assets and liabilities in the accompanying consolidated balance sheet based on
management’s best estimates. The fair value of the other current assets and
assumed liabilities were estimated by management based upon the relative short
term nature of the accounts and the fair value of the machinery and equipment
was established based upon expected replacement costs.
Management
obtained the assistance of an independent third party valuation specialist in
performing its purchase price allocation analysis. The fair value of
Bio-Quant’s tangible and identifiable intangible assets were determined based on
this analysis. The excess of the purchase price over the estimated
fair value of tangible and identifiable intangible assets acquired and
liabilities assumed was allocated to goodwill.
6
Accordingly,
the purchase price is allocated to the assets and liabilities of Bio-Quant as
presented below (in thousands):
Cash & cash equivalents
|
$ | 151 | ||
Accounts receivable
|
576 | |||
Prepaids and other current assets
|
105 | |||
Other assets
|
27 | |||
Property and equipment
|
783 | |||
Due
from related party
|
205 | |||
Accounts payable and accrued expenses
|
(1,041 | ) | ||
Related party payable
|
(85 | ) | ||
Deferred revenue
|
(45 | ) | ||
Other
current liabilities
|
(68 | ) | ||
Other long term liabilities
|
(122 | ) | ||
Amortizable
intangible assets:
|
||||
Know-How
|
3,037 | |||
Trade Name
|
1,123 | |||
Indefinite
lived intangible assets:
|
||||
Goodwill
|
9,083 | |||
Total net assets acquired
|
$ | 13,729 |
7
Intangible
assets of $4,160,000 consist primarily of developed know-how and the Bio-Quant
trade name. Developed know-how relates to Bio-Quant’s pre-clinical service
expertise including, but not limited to, its extensive inventory of internally
developed cell lines. The Bio-Quant trade name represents future revenue
attributable to the reputation and name recognition of Bio-Quant within the
pharmaceutical industry where Bio-Quant is a known expert in pre-clinical
services.
Bio-Quant
is a revenue-generating, cash-flow positive CRO. Bio-Quant is
expected to continue its revenue growth and cash generating CRO
business. The $9,083,000 of goodwill generated from the acquisition
of Bio-Quant consists largely of the expected ability of the Bio-Quant CRO to
continue to grow its revenues and generate positive cash flow to contribute to
the pharmaceutical product development business segment of the
Company.
The
following unaudited pro forma consolidated results of operations for the period
assumes the acquisition of Bio-Quant had occurred as of January 1, 2009,
giving effect to purchase accounting adjustments. The pro forma data is for
informational purposes only and may not necessarily reflect the actual results
of operations had Bio-Quant been operated as part of the Company since
January 1, 2009.
Three
Months Ended
March 31,
2009
|
||||||||
As
Presented
|
Pro
Forma
|
|||||||
Revenues
|
$ | 2,466,670 | $ | 3,800,183 | ||||
Net
Income
|
684,772 | 754,833 | ||||||
Net
income per basic and diluted shares
|
$ | 0.01 | $ | 0.01 |
3. ACCOUNTING
FOR STOCK BASED COMPENSATION
The value
of restricted stock grants are calculated based upon the closing stock price of
the Company’s Common Stock on the date of the grant. For stock
options granted to employees and directors, we recognize compensation expense
based on the grant-date fair value estimated in accordance with the appropriate
accounting guidance, and recognized over the expected service period. We
estimate the fair value of each option award on the date of grant using the
Black-Scholes option pricing model. Stock options and warrants issued to
consultants are accounted for in accordance with accounting guidance.
Compensation expense is calculated each quarter for consultants using the
Black-Scholes option pricing model until the option is fully vested and is
included in research and development or general and administrative facility
expenses, based upon the services performed by the recipient.
8
During
December 1996, the Company adopted The NexMed, Inc. Stock Option and Long-Term
Incentive Compensation Plan (“the Incentive Plan”) and The NexMed, Inc.
Recognition and Retention Stock Incentive Plan (“the Recognition
Plan”). A total of 2,000,000 shares were set aside for these two
plans. In May 2000, the stockholders of the Company approved an
increase in the number of shares reserved for the Incentive Plan and Recognition
Plan to a total of 7,500,000. During June 2006, the Company adopted
the NexMed, Inc. 2006 Stock Incentive Plan. A total of 3,000,000
shares were set aside for the plan 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 between $0.55 to $5.50. The
maximum term under these plans is 10 years.
The
following table summarizes information about options outstanding, all of which
are exercisable, at March 31, 2010:
Options
Outstanding
|
Options
Exercisable
|
||||||||||||||||||||||||||||
Range
of Exercise
Prices |
Number Outstanding |
Weighted
Average Remaining |
Weighted
Average Exercise
Price |
Aggregate Intrinsic |
Number Exercisable |
Weighted
Average Exercise
Price |
Aggregate Intrinsic |
||||||||||||||||||||||
$ | .55 - 1.40 | 2,176,557 |
5.49
years
|
$ | 0.80 | $ | - | 2,176,557 | $ | 0.80 | $ | - | |||||||||||||||||
2.00 - 3.50 | 55,000 |
2.08
years
|
3.43 | - | 55,000 | 3.43 | - | ||||||||||||||||||||||
4.90 - 5.50 | 120,001 |
3.45
years
|
4.91 | - | 120,001 | 4.91 | - | ||||||||||||||||||||||
2,351,558 |
5.31
years
|
$ | 1.07 | $ | - | 2,351,558 | $ | 1.07 | $ | - |
A summary
of stock option activity is as follows:
Weighted
|
Weighted
|
Total
|
|||||||||||
Average
|
Average
Remaining
|
Aggregate
|
|||||||||||
Number
of
|
Exercise
|
Contractual
|
Intrinsic
|
||||||||||
Shares
|
Price
|
Term
|
Value
|
||||||||||
Outstanding
at December 31, 2009
|
2,950,702 | $ | 1.40 | - | |||||||||
Granted
|
- | $ | - | ||||||||||
Exercised
|
- | $ | - | - | |||||||||
Forfeited
|
(599,144 | ) | $ | 2.67 | - | ||||||||
Outstanding
at March 31, 2010
|
2,351,558 | $ | 1.07 |
5.31
years
|
$ | 0 | |||||||
Vested
or expected to vest at
|
|||||||||||||
March
31, 2010
|
2,351,558 | $ | 1.07 |
5.31
years
|
$ | 0 | |||||||
Exercisable
at March 31, 2010
|
2,351,558 | $ | 1.07 |
5.31
years
|
$ | 0 |
There
were no stock options granted during the three months ended March 31,
2010.
9
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.
As of
March 31, 2010, there was no unrecognized compensation cost related to unvested
stock options.
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 FASB
ASC 718. As of March 31, 2010 there was $107,842 of total
unrecognized compensation cost related to unvested restricted
stock. That cost is expected to be recognized during
2010.
Principal
equity compensation transactions for the three months ended March 31, 2010 were
as follows:
For the
three months ended March 31, 2010, the Company issued 130,720 shares of common
stock to Board of Directors members for services rendered and recorded expenses
related to such issuances of $40,000.
The
following table indicates where the total stock-based compensation expense
resulting from stock options and awards appears in the Unaudited Consolidated
Statements of Operations:
10
FOR
THE THREE MONTHS
|
||||||||
ENDED
MARCH 31,
|
||||||||
2010
|
2009
|
|||||||
Research
and development
|
$ | - | $ | 47,515 | ||||
General
and administrative
|
144,553 | 284,731 | ||||||
Stock-based
compensation expense
|
$ | 144,553 | $ | 332,246 |
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.
4.
WARRANTS
A summary
of warrant activity for the three-month period ended March 31, 2010 is as
follows:
Common
Shares
|
Average
|
Average
|
|||||||
Issuable
upon
|
Exercise
|
Contractual
|
|||||||
Exercise
|
Price
|
Life
|
|||||||
Outstanding
at December 31, 2009
|
6,979,130 | $ | 1.03 |
1.03
years
|
|||||
Issued
|
- | ||||||||
Exercised
|
- | ||||||||
Expired
|
(3,215,730 | ) | $ | 1.11 | |||||
Outstanding
at March 31, 2010
|
3,763,400 | $ | 0.85 |
1.62
years
|
|||||
Exercisable
at March 31, 2010
|
3,763,400 | $ | 0.85 |
1.62
years
|
5. LOSS
PER SHARE
At March
31, 2010 and 2009, respectively, options to acquire 2,351,558 and 3,236,490
shares of Common Stock, warrants to acquire 3,763,400 and 12,118,044 shares of
Common Stock and convertible securities convertible into 6,896,552 and 2,946,429
shares of Common Stock were excluded from the calculation of diluted loss per
share, as their effect would be anti-dilutive. Loss per share for the
three months ended March 31, 2010 and 2009 was calculated as follows (net loss /
weighted average common shares outstanding):
11
FOR
THE THREE MONTHS
|
||||||||
ENDED
MARCH 31,
|
||||||||
2010
|
2009
|
|||||||
Net
income (loss)
|
$ | (9,237,456 | ) | $ | 684,772 | |||
Weighted
average common shares outstanding
|
||||||||
used
for basic and diluted income (loss) per share
|
110,682,705 | 84,388,421 | ||||||
Basic
and diluted income (loss) per common share
|
$ | (0.08 | ) | $ | 0.01 |
6. INTANGIBLE
ASSETS
Intangible
assets are listed below with associated accumulated amortization:
March
31,
2010
|
December
31, 2009
|
|||||||
Bio-Quant
Know-How
|
$ | 3,037,000 | 3,037,000 | |||||
Bio-Quant
Trade Name
|
1,123,000 | 1,123,000 | ||||||
Accumulated
amortization
|
(104,956 | ) | (14,994 | ) | ||||
Intangible
assets, net
|
$ | 4,055,044 | 4,145,006 |
The
Company is currently amortizing know-how over the expected useful life of 10
years and the Bio-Quant trade name over the expected useful life of 20 years.
Amortization expense amounted to $89,962 for the three months ended March 31,
2010. Based on the carrying amount of intangible assets, assuming no
future impairment of underlying assets, the estimated future amortization
expense for the next five years ending March 31,
2011
|
$
|
359,860
|
||
2012
|
359,860
|
|||
2013
|
359,860
|
|||
2014
|
359,860
|
|||
2015
|
359,860
|
|||
Thereafter
|
2,255,744
|
|||
Total
future amortization expense
|
$
|
4,055,044
|
12
7. CONVERTIBLE
NOTES PAYABLE
On March
15, 2010, the Company issued convertible notes (the “2010 Convertible Notes”) in
an aggregate principal amount of $4 million to the holders of the 2008
Convertible Notes discussed below. The 2010 Convertible Notes are
secured by the Company’s facility in East Windsor, New Jersey and are due on
December 31, 2012. The proceeds were used to repay the 2008
Convertible Notes then outstanding as discussed below. As such, the
Company received approximately $1.4 million in net proceeds from the issuance of
the 2010 Convertible Notes.
The 2010
Convertible Notes are payable in cash or convertible into shares of Common Stock
at an initial price of $0.58 per share, which may be subject to adjustment, on
or before the maturity date of December 31, 2012 at the holders’
option. The 2010 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.
2008 Convertible
Notes
On June
30, 2008, the Company issued convertible notes (the “2008 Convertible Notes”) in
an aggregate principal amount of $5.75 million. The 2008 Convertible
Notes were secured by the Company’s facility in East Windsor, New
Jersey. $4.75 million of the principal amount of the 2008 Convertible
Notes would have been due on December 31, 2011 (the “Due Date”) and $1 million
of the principal amount of the Convertible Notes was 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.
The 2008
Convertible Notes were payable in cash or convertible into shares of Common
Stock with the remaining principal amount initially convertible at $2 per share
on or before the Due Date at the holders’ option. The 2008
Convertible Notes had a coupon rate of 7% per annum, which was payable at the
Company’s option in cash or, if the Company’s net cash balance was 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 would 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 would be considered contingent and therefore would only
be recognized upon occurrence.
13
2009 and 2010 transactions
with respect to the 2008 Convertible Notes are as follows:
As
discussed in Note 13, the Company sold $350,000 of manufacturing equipment to
Warner. The holders of the 2008 Convertible Notes agreed to release
the lien on the equipment in exchange for a $50,000 repayment of principal that
was to be paid in 2009 when the equipment was transferred to
Warner. Accordingly, on May 15, 2009, the Company repaid $50,000 to
the holders of the 2008 Convertible Notes upon the transfer of the
manufacturing equipment to Warner.
On May
27, 2009, the Company agreed to convert $150,000 of the outstanding 2008
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 2008
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.
On July
23, 2009, the Company agreed to convert $300,000 of the outstanding 2008
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 2008
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.
On
September 16, 2009, the Company agreed to convert $350,000 of the outstanding
2008 Convertible Notes to Common Stock at a price of $0.15 per
share. As such, the Company issued 2,368,722 shares of Common Stock
to the note holders in repayment of such $350,000 principal amount plus
interest.
On
October 14, 2009, the Company agreed to convert $350,000 of the outstanding 2008
Convertible Notes to Common Stock at a price of $0.16 per share. As
such, the Company issued 2,193,455 shares of Common Stock to the note holders in
repayment of such $350,000 principal amount plus interest.
On
October 15, 2009, the Company agreed to convert $250,000 of the outstanding 2008
Convertible Notes to Common Stock at a price of $0.15 per share. As
such, the Company issued 1,671,528 shares of Common Stock to the note holders in
repayment of such $250,000 principal amount plus interest.
14
On
November 10, 2009, the Company issued convertible notes in the aggregate
principal amount of $750,000 under terms substantially similar to those of the
original 2008 Convertible Notes as described above.
On
November 10, 2009, the Company amended the 2008 Convertible Notes such that the
conversion price for $750,000 in principal amount of the 2008 Convertible Notes
was changed from $2.00 to $0.14 per share.
On
November 24, December 7, December 9 and December 14, 2009, the note holders
converted $500,000, $125,000, $35,000 and $90,000, respectively, of the
outstanding 2008 Convertible Notes pursuant to the November 10, 2009 amendment
above. As such, the Company issued 5,419,782 shares of Common Stock
to the note holders in repayment of such $750,000 principal amount plus
interest.
As a
result of these prepayments and conversions, at December 31, 2009, the principal
amount outstanding of the 2008 Convertible Notes was $2,990,000, of which the
conversion price was $2.00 per share for all such principal amount.
On
January 26, 2010, the Company agreed to convert $397,988 of the outstanding 2008
Convertible Notes to Common Stock at a price of $0.50 per share. As
such, the Company issued 800,000 shares of Common Stock to the note holders in
repayment of such $397,988 principal amount plus interest.
The
Company recognized a debt inducement charge in interest expense for the
differential between the original conversion rate of $2.00 per share and the
$0.50 price listed above. Non-cash interest expense recognized with
respect to this conversion was $1,200,000 during the three months ended
March 31, 2010.
The
remaining balance outstanding on the 2008 Convertible Notes of $2,592,012 was
repaid in full on March 15, 2010 with the proceeds received from the 2010
Convertible Notes.
8. NOTES
PAYABLE
On
December 14, 2009, the Company issued $12,129,010 in promissory notes (the
“Notes”) in connection with the acquisition of Bio-Quant as discussed in Note 2
above. The Notes bear interest at a rate of 10% per annum, with all principal
and interest accrued thereunder becoming due and payable one year from the
closing date of the Merger, or December 14, 2010. The terms of the
Notes provide that the principal amounts and all interest thereunder are payable
by the Company in cash or, at the Company’s option, in NexMed Shares, which
shall be valued at the fixed price of $0.168 per share. The Merger
Agreement provides that if the Company repays the Notes in NexMed Shares, the
total number of NexMed Shares issuable to Bio-Quant shareholders shall not
exceed 19.99% of outstanding NexMed Shares at the Effective Time unless the
Company receives stockholder approval to do so; the Company is seeking such
approval at its May 24, 2010 meeting of stockholders. If the Company
receives such stockholder approval, the total number of additional NexMed Shares
issued to Bio-Quant shareholders in payment of the Notes will be up to
approximately 63 million shares. The principal amount of the Notes
outstanding at December 31, 2009 was $12,129,010 and is reflected as Notes
payable in the current liabilities section of the Consolidated Balance
Sheet. The Company has determined that it will recognize a beneficial
conversion charge based upon the difference between the quoted market price of
the common stock and the fixed conversion price at the time of the
conversion.
15
On
January 11, 2010, the Company repaid $261,016 of outstanding principal of the
Notes through the issuance of Common Stock at $0.168 per share, which is the
fixed payment price pursuant to the terms of the Notes. As such, the
Company issued 2,107,500 shares of Common Stock to the note holders in repayment
of such $261,016 principal amount plus interest.
On March
17, 2010, the Company repaid an additional $1,969,185 of outstanding principal
of the Notes through the issuance of Common Stock at $0.168 per share, which is
the fixed payment price pursuant to the terms of the Notes. As such,
the Company issued 12,940,654 shares of Common Stock to the note holders in
repayment of such $1,969,185 principal amount plus interest.
The
Company recognized a beneficial conversion charge for the differential between
the original conversion rate of $0.168 per share and the market price of the
Company’s Common Stock at the time of the above payments. As such the
beneficial conversion charge non-cash interest expense recognized with respect
to the Notes for the three months ended March 31, 2010
was $4,512,640.
In
January 2010, the Company raised gross proceeds of $2.3 million in an offering
of unsecured promissory notes (the “2010 Notes”). The 2010 Notes
accrued interest at a rate of 10% per annum and were due and payable in full six
months from the date of issuance. The principal and accrued interest due under
the Notes was payable, at the election of the Company, in either cash or shares
of Common Stock, par value $0.001 per share (the “Shares”). The
weighted average conversion price of the 2010 Notes was $0.37 per Share, with
the conversion prices ranging from $0.36 to $0.40 per Share.
On March
17, 2010, the 2010 Notes were repaid in full with the issuance of 6,232,556
shares of common stock to repay such $2.3 million principal amount and
interest. The Company recognized a beneficial conversion charge on
the differential between the original conversion rates of $0.36 to $0.40 per
share and the market price of the Company’s Common Stock at the time of the
above repayment. The Company has recorded a beneficial conversion
charge to interest expense of $660,819 during the three months ended March
31, 2010 as a result of the conversion.
9. LINE OF
CREDIT
16
On March
8, 2010, Bio-Quant entered into a Loan and Security agreement with Square 1 Bank
for a revolving line of credit (“credit line”) in the amount of $250,000. The
credit line is secured by a $250,000 cash deposit from the Company which is
classified as restricted cash on the accompanying consolidated balance sheet at
March 31, 2010. The credit line expires on March 7, 2011 and bears interest at
4.25% per annum, or 1% above the Prime Rate.
As of
March 31, 2010, the entire credit line remained available as Bio-Quant had not
drawn down on the credit line.
In April
2010, Bio-Quant has drawn down $185,000 on the line of credit.
10. 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, 2010, the Company has
accrued $924,668 in deferred compensation.
11. RELATED
PARTY TRANSACTIONS
Approximately
63% of the Bio-Quant notes payable described in Note 8 are held by executives of
the Company.
Prior to
Merger, Bio-Quant had promissory notes receivable of approximately $380,000 from
three entities controlled by the former Bio-Quant
shareholders. Management of the Company has determined that the fair
value of these notes was $204,896 at the time of the Bio-Quant acquisition,
representing the value of Prevonco™ purchased in 2010 by the Company from one of
these entities in settlement of a like-amount of the promissory
note. Prevonco™ is a marketed anti-ulcer compound, lansoprazole, for
the treatment of solid tumors. The remainder of the notes receivable have been
assigned no fair value, as there is significant uncertainty as to whether any
amounts will be collectible.
Prior to
the Merger, Bio-Quant periodically borrowed and repaid funds from the Company’s
Chief Executive Officer and his affiliates pursuant to promissory notes bearing
interest rate of 10% per annum. The balance owed by the Company at December 31,
2009 and included in amounts due to related parties in the accompanying
consolidated balance sheet is $84,979. These amounts were repaid in full during
the first quarter of 2010.
17
12. INCOME
TAXES
The
Company has incurred losses since inception, which have generated net operating
loss carryforwards of approximately $107 million for federal and state income
tax purposes. These carryforwards are available to offset future
taxable income and expire beginning in 2014 through 2028 for federal income tax
purposes. In addition, the Company has general business and research and
development tax credit carryforwards of approximately $2.4
million. Internal Revenue Code Section 382 places a limitation on the
utilization of federal net operating loss carryforwards when an ownership
change, as defined by United States tax law, occurs. Generally, an
ownership change, as defined, occurs when a greater than 50 percent change in
ownership takes place during any three-year period. It is likely that such a
limitation will occur if most of the Bio-Quant notes are converted to common
stock. The actual utilization of net operating loss carryforwards generated
prior to such changes in ownership will be limited, in any one year, to a
percentage of fair market value of the Company at the time of the ownership
change. Such a change may have already resulted from
the equity financing obtained by the Company since its
formation.
On
January 1, 2007, we adopted the provisions of ASC 740-10-25. ASC 740-10-25
provides recognition criteria and a related measurement model for uncertain tax
positions taken or expected to be taken in income tax returns. ASC 740-10-25
requires that a position taken or expected to be taken in a tax return be
recognized in the financial statements when it is more likely than not that the
position would be sustained upon examination by tax authorities. Tax positions
that meet the more likely than not threshold are then measured using a
probability weighted approach recognizing the largest amount of tax benefit that
is greater than 50% likely of being realized upon ultimate settlement. The
Company’s Federal income tax returns for 2001 to 2008 are still open and subject
to audit. The Company had no tax positions relating to open income
tax returns that were considered to be uncertain. Accordingly, we have not
recorded a liability for unrecognized tax benefits upon adoption of ASC
740-10-25. There continues to be no liability related to unrecognized tax
benefits at March 31, 2010.
13. LICENSING
AND RESEARCH AND DEVELOPMENT AGREEMENTS
Vitaros
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”).
18
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®.and
recognized a gain of $43,840. 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 was recognized as revenue for three months ended March 31, 2009, as
the Company had 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, $2,550 and $1,700 was being recognized as
revenue for the three months ended March 31, 2010 and 2009,
respectively. The balance of $90,100 is recorded as deferred revenue
on the Consolidated Balance Sheet at March 31, 2010.
On April
15, 2009, the Company entered into a First Amendment (the “Amendment”) to the
Asset Purchase Agreement. The Amendment provided that from May 15,
2009 through September 15, 2009, the Company would 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 would provide reasonable technical and other
assistance to Warner. In consideration, Warner agreed to pay the
Company a fee of $50,000 per month, or $200,000 in the aggregate.
MycoVa
(formerly NM100060)
On
September 15, 2005, the Company signed an exclusive global licensing agreement
with Novartis International Pharmaceutical Ltd. (“Novartis”) for its anti-fungal
product, MycoVa (formerly 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 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 MycoVa (formerly
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 MycoVa (formerly
NM100060). Novartis took over all responsibilities and
completed the remaining preclinical studies.
19
In July
2008, Novartis completed testing for the Phase 3 clinical trials for MycoVa
(formerly 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.
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 has provided the Company reports associated with
the Phase 3 clinical trials conducted for MycoVa (formerly NM100060) and is
assisting and supporting the Company in connection with the assignment, transfer
and delivery to the Company of all know-how and data relating to MycoVa
(formerly 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 MycoVa (formerly NM100060), as well as a royalty fee
ranging from 2.8% to 6.5% of annual net sales of products developed from MycoVa
(formerly 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.
14. COMMITMENTS
AND CONTINGENCIES
Equity
Compensation
The
Company has made commitments to issue equity awards to certain officers of the
Company and employees of Bio-Quant. Such commitments will be
satisfied only upon approval by the shareholders of the Company to increase the
number of authorized shares in the NexMed, Inc. 2006 Stock Incentive Plan (the
“Plan”); the Company is seeking such approval at the May 24, 2010 stockholders
meeting. Upon approval of the increase in shares authorized for
issuance under the Plan, the Company will issue approximately 2,371,000
restricted shares to certain Bio-Quant employees pursuant to the provisions of
the Plan. Additionally, the Company will issue 3,750,000 shares to
certain of its officers pursuant to the provisions of the Plan.
Employment
Agreements
20
We have
an employment agreement with Dr. Damaj, our President and Chief Executive
Officer. Pursuant to that agreement, we may terminate Dr. Damaj’s employment
without cause on ten days notice, in which event Dr. Damaj would be entitled to
severance pay equal to twelve months’ base salary. Under the employment
agreement, if we had terminated Dr. Damaj effective December 31, 2009, based on
his 2009 compensation, he would have been paid an aggregate of $300,000, his
2009 base salary, and $100,000, which represents twice his accrued 2009
bonus. The employment agreement further provides that in the event
that within one year after a “Change of Control” (as defined therein) of the
Company occurs, and the President and Chief Executive Officer’s employment is
terminated or resigns for cause, the President and Chief Executive Officer will
be paid a lump sum amount equal to their base salary for a 12-month period
following termination or resignation. Based on this change of control provision,
if there had been a change of control of the Company in 2009 and Dr. Damaj’s
employment had terminated effective December 31, 2009, either for “Good Reason”
or without cause, then Dr. Damaj would have been entitled to termination pay
equal to $300,000.
15. SEGMENT
INFORMATION
NexMed
operates in two segments: the NexACT® drug
delivery technology business and the Bio-Quant CRO business. The
NexACT® drug
delivery technology business segment consists of designing and developing
pharmaceutical products using the Company’s proprietary NexACT® drug
delivery technology. This segment performs research and development
by creating new pharmaceutical products through the successful application of
the NexACT®
technology to improve therapeutic outcomes and reduce systemic side effects that
often accompany existing oral and injectable medications. The
Bio-Quant CRO business segment provides pre-clinical CRO services to
pharmaceutical and biotechnology companies in the areas of in vitro and in vivo pharmacology,
pharmacokinetics (PK) and toxicology to support pre-investigational new drug
(“pre-IND”) enabling packages.
Segment
information for the three months ended March 31, 2010 follows:
21
NexACT® Drug
Delivery
|
Bio-Quant
CRO
|
Other
Corporate Not Allocated to Segments
|
Consolidated
Total
|
|||||||||||||
Revenue
|
$ | 2,550 | $ | 1,443,202 | $ | - | $ | 1,445,752 | ||||||||
Cost
of Services
|
- | 1,037,232 | - | 1,037,232 | ||||||||||||
Gross
Profit
|
$ | 2,550 | $ | 405,970 | $ | - | $ | 408,520 | ||||||||
Costs
and expenses
|
||||||||||||||||
Research
and development
|
426,393 | - | - | 426,393 | ||||||||||||
General
and administrative
|
- | 576,493 | 1,663,043 | 2,239,536 | ||||||||||||
Loss
from operations
|
$ | (423,843 | ) | $ | (170,523 | ) | $ | (1,663,043 | ) | $ | (2,257,409 | ) | ||||
Total
Assets
|
$ | - | $ | 15,097,452 | $ | 7,194,043 | $ | 22,291,495 | ||||||||
Capital
Expenditures
|
$ | - | $ | 80,741 | $ | 1,804 | $ | 82,545 |
16. SUBSEQUENT
EVENT
On April
21, 2010, the Company entered into a Sales Agreement with Brinson Patrick
Securities Corporation (the “Sales Manager”) to issue and sell through the Sales
Manager, as agent, up to $10,000,000 of common stock from time to time pursuant
to the Company’s effective shelf registration statement on Form S-3 (File No.
333-165960). Through May 12, 2010, the Company had sold an aggregate
of approximately 5.1 million shares of common stock under the Sales Agreement at
a weighted average sales price of approximately $0.48 per share, resulting in
offering proceeds of approximately $2.4 million, net of sales
commissions. As a result of these sales of stock, the conversion price of
the Convertible Notes described above in Note 7 will be adjusted pursuant to the
weighted average antidilution features contained in those notes.
22
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, 2009 filed with the Securities and
Exchange Commission on March 31, 2010. 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, anticipated revenue growth, manufacturing,
competition, and/or other factors, many of which are outside our
control.
Corporate
History
We are a
Nevada corporation and have been in existence since 1987. We have
operated in the pharmaceutical industry since 1995, focusing on research and
development in the area of drug delivery. Our proprietary drug
delivery technology is called NexACT®
.
In 2005
and 2007 we entered into licensing agreements with Novartis International
Pharmaceutical Ltd. (“Novartis”) and Warner Chilcott Company, Inc. (“Warner”),
respectively, pursuant to which we granted to Novartis and Warner rights to
develop and commercialize products we developed using the NexACT®
technology. Please see the NexACT® Drug
Delivery Technology section below for a detailed discussion about MycoVa
(formerly NM100060), our proprietary topical nail solution for the treatment of
onychomycosis (nail fungal infection), which we licensed to Novartis in 2005 and
Vitaros®,, a
topical alprostadil-based cream treatment intended for patients with erectile
dysfunction, which we licensed to Warner in 2007. Also see Note 13 of
the Notes to the Consolidated Financial Statements for a description of the
licensing agreements and their current status.
On
December 14, 2009, we acquired Bio-Quant, Inc. (“Bio-Quant”), the largest
specialty biotechnology contract research organization (CRO) based in San Diego,
California and one of the industry's most experienced CROs for non-GLP (good
laboratory practices) in
vitro and in
vivo contract drug discovery and pre-clinical development services,
specializing in oncology, inflammation, immunology, and metabolic diseases.
Bio-Quant has over 300 clients world-wide and performs hundreds of studies a
year both in in vitro
and in vivo
pharmacology, pharmacokinetics (PK) and toxicology to support
pre-investigational new drug (“IND”) enabling packages. Bio-Quant’s revenue to
date has been derived from pre-clinical contract services, sales of diagnostic
kits and housing services.
As a
result of our acquisition of Bio-Quant, we now have two operating segments:
designing and developing pharmaceutical products (“The NexACT® drug
delivery technology business”) and providing pre-clinical CRO services (“The
Bio-Quant CRO business”). The sales of diagnostic kits by Bio-Quant
does not constitute a reporting segment as the assets and revenues are not
material in relation to our operations as a whole.
23
Growth
Strategy
We are
currently focusing our efforts on new and patented pharmaceutical products based
on our patented drug delivery technology known as NexACT® and on
growing the newly acquired CRO business through both organic growth within
Bio-Quant’s current business operations and through the acquisition of small
cash flow positive entities that have complementary capabilities to those of
Bio-Quant but are not operating at full capacity due to insufficient business
development efforts. We believe this strategy will allow Bio-Quant to
expand its operations by broadening its service capabilities and going into new
markets.
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 in the near term or expired and (4) with proven market track
records and potential. Further, with the pre-clinical and formulation
expertise derived from the acquisition of Bio-Quant, we have begun to develop
new formulations based on the application of NexACT®
technology to drug compounds in the areas of oncology, inflammation, immunology,
and metabolic diseases. We also intend to actively promote the NexACT
technology to Bio-Quant clients as well as other companies seeking innovative
alternatives and solutions to their development problems.
Our
broader goal is to generate revenues from the growth of our CRO business while
aggressively seeking to monetize the NexACT®
technology through out-licensing agreements with pharmaceutical and
biotechnology companies worldwide. At the same time we are actively
pursuing partnering opportunities for our clinical stage NexACT® based
treatments in the areas of dermatology and sexual dysfunction as discussed
below. The
successful licensing or sale of one or more of these products would generate
additional revenues for funding our growth strategy.
NexACT
Drug Delivery Technology
The
NexACT® drug
delivery technology is designed to enhance the delivery of an active drug to the
patient. Successful application of the NexACT®
technology would improve therapeutic outcomes and reduce systemic side effects
that often accompany existing 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.
Through
the acquisition of Bio-Quant we have expanded our research and development
capabilities with NexACT® into the
areas of oncology, inflammation, immunology, and metabolic
diseases. In addition, we are conducting additional studies to extend
the validation of the NexACT technology into the oral or subcutaneous delivery
of classes of drugs for these and other indications.
24
On
January 12, 2010, we announced results from a pre-clinical study which supported
the ability of the NexACT technology to deliver an oral formulation of Taxol®
(paclitaxel) and to enhance the drug’s bioavailability by approximately ten-fold
through this oral administration. Taxol, a first line chemotherapy drug used to
treat breast, lung and ovarian cancers, is currently administered through an
intravenous infusion that can take up to 24 hours to complete. Taxol® is a
registered trademark of Bristol-Myers Squibb Company.
On March
17, 2010, we announced results from a pre-clinical study which successfully
demonstrated the ability of the NexACT technology to deliver insulin and other
large molecule drugs such as Taxol subcutaneously, in a depot-like fashion (or
slow release) over a 24 hour period from a single injection. Specifically,
rodents that received insulin injections incorporating the NexACT technology
showed bio-equivalency to Lantus® in
controlling glucose levels in the blood. Further studies in rodents
showed that NexACT was able to deliver Taxol®
subcutaneously in levels similar to those previously observed in NexACT-based
oral Taxol formulation without any apparent toxicity. Lantus®,a
product of Sanofi Aventis, is a commonly prescribed insulin injection for
treating diabetes. Additionally, we are continuing to further develop
our NexACT formulation of Taxol® in
anticipation of potential human clinical trials.
In March
2010, we acquired PrevOnco™, a marketed anti-ulcer compound, lansoprazole, for
the treatment of solid tumors. Based on in vivo mouse data, the
product looks promising for treating human hepatocellular carcinoma (HCC), or
liver cancer. In addition, PrevOnco™ has received Orphan Drug
Designation by the US FDA for HCC. On March 25, 2010, we filed the
IND including a proposed Phase 2 clinical protocol for PrevOnco™.
On April
26, 2010 we announced that the FDA cleared us to proceed with our proposed Phase
2 clinical study of PrevOnco™ as a
first line therapy for treating HCC. Additionally, in IND review
communication, the FDA gave us the opportunity to move PrevOnco™ directly
into a Phase 3 trial that would support marketing approval, subject to positive
study results. In order to pursue this regulatory path, we would need
to expand the proposed Phase 2 study design to use PrevOnco™ in
combination with Doxorubicin as a second-line therapy for patients who have
failed NEXAVAR®, the
currently marketed first-line anticancer treatment in the U.S., for patients
with either HCC or advanced renal cell carcinoma (cancer of the
kidney). NEXAVAR® is
marketed by Bayer HealthCare Pharmaceuticals, Inc
MycoVa
Anti-Fungal Treatment (formerly NM100060)
We had an
exclusive global licensing agreement with Novartis International Pharmaceutical
Ltd. (“Novartis”) for MycoVa (formerly NM100060), our proprietary topical nail
solution for the treatment of onychomycosis (nail fungal infection). Under the
agreement, Novartis acquired the exclusive worldwide rights to MycoVa (formerly
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.
25
The
completion of patient enrollment in the Phase 3 clinical trials for MycoVa
(formerly 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 MycoVa (formerly 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 MycoVa (formerly
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 the Phase 3 clinical trials for MycoVa (formerly
NM100060). The Phase 3 program required for the filing of the New
Drug Application (“NDA”) in the U.S. for MycoVa (formerly NM100060) consisted of
two pivotal, randomized, double-blind, placebo-controlled
studies. The parallel studies were designed to assess the efficacy,
safety and tolerability of MycoVa (formerly 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.
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 MycoVa
(formerly 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 MycoVa (formerly NM100060), as well as a royalty fee ranging from
2.8% to 6.5% of annual net sales of products developed from MycoVa (formerly
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.
26
We have completed our analysis of the
two pivotal Phase 3 studies completed by Novartis. Based on this
analysis, we believe the product’s potential for treating patients with mild
onychomycosis and warrants further studies for regulatory
approval. We are sharing the clinical database and our conclusion
with potential partners interested in licensing NM100060 for further development
or for Over The Counter (OTC) direct approval due to its safety
profile.
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 above
mentioned requirements prior to the resubmission of the NDA.
27
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 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., which may benefit us in 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 submitted the CAC
assessment package to the FDA during the 4th quarter
of 2009. Based on previous discussion with the FDA, we had expected them
to make their decision during the first quarter of 2010. However, as
of the date of this report, we have nothing new to report.
In
Canada, we filed the New Drug Submission (“NDS”) for Vitaros in February 2008
and received a Notice of Non-Compliance (“Notice”) on January 19, 2010.
The Notice was an end-of-review communication from Health Canada when additional
information was needed to reach final decision on product approval. The
deficiencies cited in the Notice were related specifically to the product’s CMC
(Chemistry, Manufacturing and Controls), and no pre-clinical or clinical
deficiencies were cited in the Notice. In February 2010, we met with
Health Canada to discuss their concerns and were able to reach agreement with
them on the necessary action steps which would be completed and included in our
response to the Notice. On April 22, 2010, we announced that we filed our
response to the Notice. Health Canada has a 45-day screening process
for acceptance of the Response by their Regulatory Project Management
group. The acceptance of the Response triggers a new 150-day review
cycle by the NDS reviewers for a final approval or rejection of the marketing
application.
For
Europe, we are currently pursuing a decentralized filing strategy and our first
Marketing Authorization Application (“MAA”) is planned for the United
Kingdom. The Medicines and Healthcare Products Regulatory Agency (the
“MHRA”) has confirmed that due to the backlog of MAA filings, they would not be
able to receive and start reviewing our MAA until October 2010. Our
intention is to pursue filing of the MAA with a local European partner.
With that goal in mind, we are actively pursuing licensing partners and have
engaged a business development consultant to assist us in that endeavour.
There is no assurance that we will be able to find a partner, file our MAA on a
timely basis or obtain regulatory approval.
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.
28
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. We have
in our pipeline a viable topical treatment for psoriasis, a common
dermatological condition. Since the acquisition on December 14, 2009, our
Bio-Quant team has been reviewing and studying the pre-clinical stage topical
products in our pipeline to determine if additional value can be created through
further testing in-house. These products include the above-mentioned treatment
for psoriasis, cancer, inflammation and also treatments for pain and wound
healing.
Bio-Quant
CRO Business
Bio-Quant
has over 300 clients world-wide and performs hundreds of studies a year both in
in vitro and in vivo pharmacology,
pharmacokinetics (PK) and toxicology to support pre-IND enabling packages.
Bio-Quant performs studies for its clients in the early stages of drug
development and discovery. To provide the needed flexibility, this
discovery work is best performed by Bio-Quant’s highly experienced and trained
scientists who know how to recognize and address the unusual and unexpected
outcomes that are the norm during discovery. Because the path to success at the
discovery stage is through the process of failing fast and failing often, the
optimal discovery research methodology focuses on the fastest and most
cost-effective methods for getting correct scientific answers to direct further
research.
To date,
approximately 80% of Bio-Quant’s revenue has been generated from pre-clinical
contract services. The CRO industry in general continues to be
dependent on the research and development efforts of pharmaceutical and
biotechnology companies as major customers, and we believe this dependence will
continue. The current uncertain economic conditions is believed to
have caused customers to re-evaluate priorities resulting in increases in
contracts for the more promising projects, scaling back and/or canceling other
GLP projects towards clinical trials. Many companies in the
biopharmaceutical industry are reducing costs and, often, their
workforce. Bio-Quant may benefit from increased outsourcing on the
part of its customers, or it may be harmed by a reduction in spending if the
biopharmaceutical industry scales back on pre-clinical
projects. Bio-Quant views the current conditions as an opportunity to
attract well qualified candidates to strengthen and improve its
operations. Another trend in the industry is the decline in
prescription drug sales caused by cost conscious patients opting for less
expensive generic drugs or none at all. This presents both an
opportunity and a challenge to Bio-Quant, as its customers will need to find
less costly, or more efficient research options often through the establishment
of strategic alliances or partnerships. Bio-Quant believes it is well
positioned for this development.
With
access to our NexACT technology, we intend to differentiate the Bio-Quant
business from its competitors because it now can offer a proprietary drug
delivery technology as a service to current and potential clients who need
innovative alternatives and solutions to their development
problems.
Bio-Quant
has two labs and housing facilities along with an experienced scientific staff
of 19 employees.
29
There are
many different types of clients that need these types of studies performed
during these early stages of drug discovery and
development. Bio-Quant’s clients range from larger global
pharmaceutical companies to midsize and small biotechnology
companies.
Liquidity
and Capital Resources.
We have
experienced net losses and negative cash flows from operations each year since
our inception. Through March 31, 2010, we had an accumulated deficit
of $180,969,318. 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,
2009 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, 2010, we had cash and cash equivalents of approximately $2.8 million as
compared to $480,000 at December 31, 2009. During the first
quarter of 2010, we received net proceeds of approximately $3.6 million as a
result of the issuance of convertible Notes as discussed in Note 7 of the Notes
to the Unaudited Consolidated Financial Statements. The receipt of
this cash during the first quarter of 2010 was offset by our cash
used. Our net cash outflow during the first quarter was approximately
$1.28 million which includes approximately $437,000 in proceeds received during
the quarter from the sale of our New Jersey net operating losses in
2009. During the quarter our Bio-Quant CRO had a net cash outflow of
approximately $163,000. Our monthly administrative overhead,
including public company expenses, is approximately $150,000 per
month. Additionally, we spent approximately $143,000 for our 2009
annual audit fee, $261,000 in legal fees for various transactions including the
Notes issued as discussed in Note 7 and Note 8 of the Notes to the Unaudited
Consolidated Financial Statements, the Special Meeting of our shareholders held
in March and also fees related to the acquisition of Bio-Quant in
2009. We also spent approximately $427,000 for the development
of our NexACT technology and related pipeline products. During the
first quarter, we spent approximately $137,000 in severance and accrued vacation
paid as part of our restructuring program implemented in December 2008, $93,000
in costs related to managing our building in East Windsor, NJ before the tenant
took occupancy in February 2010, and $110,000 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.
On April
21, 2010, we entered into a Sales Agreement with Brinson Patrick
Securities Corporation (the “Sales Manager”) to issue and sell through the Sales
Manager, as agent, up to $10,000,000 of common stock from time to time pursuant
to our effective shelf registration statement on Form S-3 (File No.
333-165960). Through May 12, 2010, the Company had sold an aggregate
of approximately 5.1 million shares of common stock under the Sales Agreement at
a weighted average sales price of approximately $0.48 per share, resulting in
offering proceeds of approximately $2.4 million, net of sales
commissions.
30
Our
current cash reserves of approximately $4.5 million as of the date of this
report, which includes the net proceeds raised to date from the above Sales
Agreement, should provide us with sufficient cash to fund our operations well
into the second half of 2011 assuming we convert or extend the maturity of
significant amounts due in 2010 and 2011 under notes payable as discussed in
Note 8 of the Consolidated Financial Statements. This projection is
based on the monthly operating expenses of maintaining our public listing
together with continued research and development expenses related to the NexACT
drug delivery technology along with Bio-Quant’s business growing in line with
projected rates over 2009 levels with no additional acquisitions in
2010.
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 31, 2010.
Results
of Operations.
Comparison
of Three Months Ended March 31, 2010 and 2009
Revenue. We
recorded $1,445,752 in revenue during the first quarter of 2010, as compared to
$2,466,670 in revenue during the first quarter of 2009. The
2009 revenue is primarily attributable to the sale of the U.S. rights of
Vitaros® to
Warner as discussed in Note 13 of the Notes to Unaudited Consolidated Financial
Statements. The 2010 revenue is almost entirely attributable to the
sales of CRO services by our Bio-Quant CRO. We will expect to
continue to see this level of revenue generated on a quarterly basis from our
Bio-Quant CRO in 2010.
Research and Development
Expenses. Our research and development expenses for the first
quarter of 2010 and 2009 were $426,393 and $602,366,
respectively. While we began to reduce our research and development
expenses in 2009, we have now begun to increase our research and development
expenses again as a result of the acquisition of Bio-Quant in December
2009. We expect to see an increase in research and development
spending in 2010 as a result of the acquisition of Bio-Quant and the expansion
of our NexACT®
technology into the areas of oncology, inflammation, immunology, and
metabolic diseases.
31
General and Administrative
Expenses. Our general and administrative expenses were
$2,239,536 during the first quarter of 2010 as compared to $1,091,047 during the
same period in 2009. The increase is due to the costs
associated with the special meeting of shareholders held in March 2010, as well
as the increase in expenses related to the Bio-Quant CRO
business. There was no such meeting in 2009 and the Bio-Quant CRO
business was not acquired until December 2009.
Interest Expense,
Net. We had net interest expense of $6,980,047 during the
first quarter of 2010, as compared to $88,485 during the same period in
2009. The increased interest expense is the result of interest
expense recognized on the beneficial conversion feature of the convertible notes
as discussed in Notes 7 and 8 to the unaudited consolidated financial
statements. Non-cash interest expense was $6,838,943 and $7,592 for
the first quarter ended March 31, 2010 and 2009, respectively.
Net Income
(Loss). The net loss was ($9,237,456) or ($0.08) per share in
the first quarter of 2010 as compared to net income of $684,772 or $0.01 per
share during the same period in 2009. The decrease in net income
which resulted in the net loss is primarily attributable to the increased
general and administrative expenses and non-cash interest charges as discussed
above. Additionally, in 2009, there was a one-time transaction for
the sale of U.S. rights of Vitaros® to
Warner as discussed in Note 13 of the Notes to Unaudited Consolidated Financial
Statements, which increased revenue.
Off-Balance Sheet
Arrangements
We have
no off-balance sheet arrangements that have or are reasonably likely to have a
current or future effect on our consolidated financial condition, changes in our
consolidated financial condition, expenses, consolidated results of operations,
liquidity, capital expenditures or capital resources.
ITEM
3. QUALITATIVE
AND QUANTITATIVE DISCLOSURES ABOUT MARKET RISK
There have been no material changes to
our exposures to market risk since December 31, 2009.
ITEM
4T. 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.
32
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
31, 2010.
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 31, 2010.
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.
|
33
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 13, 2010
|
|
/s/ Mark Westgate | |
Mark Westgate | |||
Vice President and Chief Financial | |||
Officer |
34
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.
|
35