SEELOS THERAPEUTICS, INC. - Quarter Report: 2010 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,
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).
Yes o No
o
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer, or a smaller reporting
company. See definitions of “large accelerated filer”, “accelerated
filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act (check
one):
Large
accelerated filer 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 August 10, 2010,
12,824,692 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, 2010 (unaudited) and December 31,
2009
|
3
|
||
Unaudited
Consolidated Statements of Operations for the Three and Six Months Ended
June 30, 2010 and June 30, 2009
|
4
|
||
Unaudited
Consolidated Statement of Changes in Stockholders’ Equity
|
5
|
||
Unaudited
Consolidated Statements of Cash Flows for the Six Months Ended June 30,
2010 and June 30, 2009
|
6
|
||
Notes
to Unaudited Consolidated Financial Statements
|
7
|
||
Item
2.
|
Management's
Discussion and Analysis of Financial Condition and Results of
Operations
|
27
|
|
Item
3.
|
Quantitative
and Qualitative Disclosures about Market Risk
|
37
|
|
Item
4.
|
Controls
and Procedures
|
37
|
|
Part
II. OTHER INFORMATION
|
37
|
||
Item
1.
|
Legal
Proceedings
|
37
|
|
Item 1A.
|
Risk
Factors
|
37
|
|
Item
6.
|
Exhibits
|
38
|
|
Signatures |
39
|
||
Exhibit Index |
40
|
2
PART
I. FINANCIAL INFORMATION
ITEM 1. FINANCIAL
STATEMENTS
NexMed,
Inc.
Consolidated
Balance Sheets
June
30,
|
December
31,
|
|||||||
2010
|
2009
|
|||||||
(Unaudited)
|
||||||||
Assets
|
||||||||
Current
assets:
|
||||||||
Cash
and cash equivalents
|
$ | 4,215,095 | $ | 479,888 | ||||
Accounts
receivable
|
641,716 | 708,898 | ||||||
Other
receivable
|
- | 437,794 | ||||||
Prepaid
expenses and other assets
|
257,581 | 140,521 | ||||||
Total
current assets
|
5,114,392 | 1,767,101 | ||||||
Fixed
assets, net
|
5,620,741 | 5,616,811 | ||||||
Goodwill
|
9,084,476 | 9,084,476 | ||||||
Restricted
cash
|
603,000 | - | ||||||
Intangible
assets, net of accumulated amortization
|
3,965,082 | 4,145,006 | ||||||
Due
from related party
|
- | 204,896 | ||||||
Debt
issuance cost, net of accumulated amortization of $10,718 and
$169,304
|
92,972 | 115,047 | ||||||
Total
assets
|
$ | 24,480,663 | $ | 20,933,337 | ||||
Liabilities and stockholders'
equity
|
||||||||
Current
liabilities:
|
||||||||
Notes
payable - former Bio-Quant shareholders
|
$ | - | $ | 12,129,010 | ||||
Accounts
payable and accrued expenses
|
1,333,499 | 1,453,621 | ||||||
Payroll
related liabilities
|
418,083 | 279,960 | ||||||
Short-term
borrowing from banks
|
401,000 | - | ||||||
Deferred
revenue - current portion
|
107,108 | 118,115 | ||||||
Capital
lease payable - current portion
|
25,811 | 24,530 | ||||||
Due
to related parties
|
- | 99,682 | ||||||
Deferred
compensation - current portion
|
68,596 | 70,000 | ||||||
Total
current liabilities
|
2,354,097 | 14,174,918 | ||||||
Long
term liabilities:
|
||||||||
Convertible
notes payable
|
4,000,000 | 2,990,000 | ||||||
Deferred
revenue
|
77,350 | 82,450 | ||||||
Capital
lease payable
|
101,374 | 114,965 | ||||||
Deferred
compensation
|
839,510 | 865,602 | ||||||
Total
liabilities
|
7,372,331 | 18,227,935 | ||||||
Commitments
and contingencies (Note 15)
|
||||||||
Stockholders'
equity:
|
||||||||
Common
stock, $.001 par value, 18,000,000 and 8,000,000
|
||||||||
shares
authorized, 12,626,541 and 6,988,105
|
||||||||
and
outstanding, respectively
|
12,626 | 6,988 | ||||||
Additional
paid-in capital
|
202,343,672 | 174,430,276 | ||||||
Accumulated
deficit
|
(185,247,966 | ) | (171,731,862 | ) | ||||
Total
stockholders' equity
|
17,108,332 | 2,705,402 | ||||||
Total
liabilities and stockholders' equity
|
$ | 24,480,663 | $ | 20,933,337 |
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,
|
|||||||||||||||
2010
|
2009
|
2010
|
2009
|
|||||||||||||
License
fee revenue
|
$ | 32,550 | $ | 102,613 | $ | 35,100 | $ | 2,569,283 | ||||||||
Contract
service revenue
|
1,438,377 | - | 2,881,579 | - | ||||||||||||
Total
revenue
|
1,470,927 | 102,613 | 2,916,679 | 2,569,283 | ||||||||||||
Cost
of services
|
1,021,951 | - | 2,059,183 | - | ||||||||||||
Gross
profit
|
448,976 | 102,613 | 857,496 | 2,569,283 | ||||||||||||
Costs
and expenses
|
||||||||||||||||
Research
and development
|
477,566 | 716,453 | 903,959 | 1,318,819 | ||||||||||||
General
and administrative
|
2,640,400 | 694,749 | 4,879,936 | 1,785,796 | ||||||||||||
Total
costs and expenses
|
3,117,966 | 1,411,202 | 5,783,895 | 3,104,615 | ||||||||||||
Loss
from operations
|
(2,668,990 | ) | (1,308,589 | ) | (4,926,399 | ) | (535,332 | ) | ||||||||
Interest
expense, net
|
(1,609,657 | ) | (117,569 | ) | (8,589,704 | ) | (206,054 | ) | ||||||||
Net
loss
|
$ | (4,278,648 | ) | $ | (1,426,158 | ) | $ | (13,516,104 | ) | $ | (741,386 | ) | ||||
Basic
and diluted loss per common share
|
$ | (0.47 | ) | $ | (0.25 | ) | $ | (1.64 | ) | $ | (0.13 | ) | ||||
Weighted
average common shares outstanding
|
||||||||||||||||
used
for basic and diluted loss per share
|
9,140,451 | 5,625,895 | 8,264,515 | 5,641,166 |
See notes
to unaudited consolidated financial statements.
4
NexMed,
Inc.
Consolidated
Statement of Changes in Stockholders' Equity (Unaudited)
Common
|
Common
|
Additional
|
Total
|
|||||||||||||||||
Stock
|
Stock
|
Paid-In
|
Accumulated
|
Stockholders'
|
||||||||||||||||
(Shares)
|
(Amount)
|
Capital
|
Deficit
|
Equity
|
||||||||||||||||
Balance
at December 31, 2009
|
6,988,105 | $ | 6,988 | $ | 174,430,276 | $ | (171,731,862 | ) | $ | 2,705,402 | ||||||||||
Issuance
of compensatory stock to employees
|
- | - | 1,114,936 | - | 1,114,936 | |||||||||||||||
Issuance
of compensatory stock to the board of directors
|
8,715 | 9 | 79,991 | - | 80,000 | |||||||||||||||
Issuance
of common stock, net of offering costs
|
518,264 | 518 | 3,298,522 | - | 3,299,040 | |||||||||||||||
Issuance
of common stock in payment of convertible notes payable
|
468,837 | 469 | 4,578,362 | - | 4,578,831 | |||||||||||||||
Issuance
of common stock in payment of notes payable to the former Bio-Quant
shareholders
|
4,642,620 | 4,642 | 18,841,585 | - | 18,846,227 | |||||||||||||||
Net
loss
|
- | - | - | (13,516,104 | ) | (13,516,104 | ) | |||||||||||||
Balance
at June 30, 2010
|
12,626,541 | $ | 12,626 | $ | 202,343,672 | $ | (185,247,966 | ) | $ | 17,108,332 |
See notes
to unaudited consolidated financial statements.
5
NexMed,
Inc.
Consolidated
Statements of Cash Flows (Unaudited)
FOR THE SIX MONTHS ENDED
|
||||||||
JUNE 30,
|
||||||||
2010
|
2009
|
|||||||
Cash
flows from operating activities
|
||||||||
Net
loss
|
$ | (13,516,104 | ) | $ | (741,386 | ) | ||
Adjustments
to reconcile net loss to net cash used in
|
||||||||
operating
activities
|
||||||||
Depreciation
and amortization
|
471,398 | 201,767 | ||||||
Non-cash
interest, amortization of beneficial conversion feature
and
|
||||||||
deferred
financing costs
|
8,716,575 | 51,762 | ||||||
Non-cash
compensation expense
|
1,194,927 | 573,234 | ||||||
(Gain)
loss on disposal of fixed assets
|
312 | (42,869 | ) | |||||
Increase
in prepaid expenses and other assets
|
(117,060 | ) | (65,797 | ) | ||||
Decrease
in accounts receivable
|
67,182 | - | ||||||
Decrease
in other receivable
|
437,794 | - | ||||||
Decrease
in due from related party
|
204,896 | |||||||
Decrease
in accounts payable and accrued expenses
|
(120,122 | ) | (198,583 | ) | ||||
Increase
(decrease) in payroll related liabilities
|
138,124 | (232,722 | ) | |||||
Decrease
in due to related party
|
(99,682 | ) | - | |||||
Decrease
in deferred compensation
|
(27,496 | ) | (41,873 | ) | ||||
(Decrease)
increase in deferred revenue
|
(16,107 | ) | 147,750 | |||||
Net
cash used in operating activities
|
(2,665,363 | ) | (348,717 | ) | ||||
Cash
flows from investing activities
|
||||||||
Proceeds
from sale of fixed assets
|
1,142 | 350,000 | ||||||
Capital
expenditures
|
(296,856 | ) | (2,928 | ) | ||||
Net
cash (used in) provided by investing activities
|
(295,714 | ) | 347,072 | |||||
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
|
3,896,310 | - | ||||||
Issuance
of common stock, net of offering costs
|
3,306,296 | - | ||||||
Procceds
from short-term borrowing
|
401,000 | - | ||||||
Repayment
of convertible notes payable
|
(2,592,012 | ) | (50,000 | ) | ||||
Repayment
of capital lease obligations
|
(12,310 | ) | - | |||||
Net
cash provided by (used in) financing activities
|
7,299,284 | (50,000 | ) | |||||
Net
change in cash and cash equivalents
|
4,338,207 | (51,645 | ) | |||||
Cash
and cash equivalents, beginning of period
|
$ | 479,888 | $ | 2,862,960 | ||||
Cash
and cash equivalents, end of period
|
$ | 4,818,095 | $ | 2,811,315 | ||||
Supplemental
Information:
|
||||||||
Issuance
of common stock in payment of convertible notes payable
|
$ | 397,888 | $ | 300,000 | ||||
Issuance
of common stock in payment of notes payable to
|
||||||||
former
Bio-Quant shareholders
|
$ | 12,129,010 | $ | - | ||||
Cash
paid for interest
|
$ | 67,762 | $ | - |
See notes
to unaudited consolidated financial statements.
6
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 14 for descriptions of the 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 (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 performs both in vitro and in vivo pharmacology,
pharmacokinetic (PK) and toxicology studies to support pre-regulatory filing
packages.
The
Company is currently focusing its efforts on the development of new and patented
pharmaceutical products, some of which are based on NexACT®, and on
seeking to grow the CRO business operated through the Bio-Quant
subsidiary.
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. The Company is actively pursuing
partnering opportunities for its clinical stage NexACT® based
and non NexACT® based
treatments in the areas of oncology, inflammation, dermatology, pain, autoimmune diseases 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 now operates in two segments –
designing and developing pharmaceutical products and providing pre-clinical CRO
services through its subsidiary, Bio-Quant.
Effective June 21, 2010, the
Company completed a reverse stock split pursuant to which each fifteen shares of
Company's common stock then issued and outstanding was automatically converted
into one share of the Company's common stock; no change was made to the
per-share par value of the common stock. The authorized capital stock was also
proportionately reverse split by a factor of fifteen-for-one. All share and per
share amounts in the accompanying consolidated financial statements have been
adjusted to reflect the reverse stock split as if it had occurred at the
beginning of the earliest period presented.
7
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 $185,247,966 at June 30, 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 certain notes payable due within
24 months, which if not converted to common stock or re-financed, would
significantly impact liquidity. These obligations 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,
expansion 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 11 for a
description 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 Accounting
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
November 20, 2009, the Company entered into the Merger Agreement with Bio-Quant.
Pursuant to the Merger Agreement, on December 14, 2009 (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.
8
The Notes
accrued 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 were payable by the Company in cash or, at the
Company’s option, in NexMed Shares, which would be valued at the fixed price of
$2.52 per share. The Merger Agreement provides that if the Company
repaid the Notes in NexMed Shares, the total number of NexMed Shares issuable to
Bio-Quant shareholders could not exceed 19.99% of outstanding NexMed Shares at
the Effective Time unless the Company received stockholder approval to do
so in accordance with applicable
rules of the NASDAQ Stock Market. The Company received
stockholder approval at its May 24, 2010 meeting for the potential issuance of
shares in full repayment of the remaining amounts owed under the Notes, and, on June 21, 2010, the Company
repaid the remaining outstanding principal and interest accrued under the Notes
in NexMed Shares.
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.
9
Accordingly,
the purchase price has been 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 |
10
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 $9,084,476 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.
Consolidated
Pro Forma Statements of Operations (unaudited)
Six Months Ended
June 30, 2009
|
||||||||
As Presented
|
Pro Forma
|
|||||||
Revenues
|
$ | 2,569,283 | $ | 5,645,154 | ||||
Net
(loss) income
|
(741,386 | ) | 531,408 | |||||
Net
(loss) income per basic and diluted shares
|
$ | (0.13 | ) | $ | 0.09 |
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.
11
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 133,333 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 500,000. During
June 2006, the Company adopted the NexMed, Inc. 2006 Stock Incentive Plan (the
“2006 Plan”). A total of 200,000 shares were set aside for the 2006
Plan and an additional 133,333 shares were added to the 2006 Plan in June
2008. The Company received stockholder approval at its May 24,
2010 meeting to add an additional 1,000,000 shares to the 2006
Plan. Options granted
under the Company’s plans generally vest over a period of one to five years,
with exercise prices of currently outstanding options ranging between $8.25 to
$74.10. The maximum term for options granted under these plans is 10
years.
The following table summarizes
information about options outstanding, all of which are exercisable, at June 30,
2010:
Options
Outstanding
|
||||||||||||||
Weighted Average
|
Aggregate
|
|||||||||||||
Range
of
|
Number
|
Remaining
|
Weighted Average
|
Intrinsic
|
||||||||||
Exercise
Prices
|
Outstanding
|
Contractual
Life
|
Exercise
Price
|
Value
|
||||||||||
$
|
8.25
- 21.00
|
145,104 |
5.24
years
|
$ | 11.99 | $ | - | |||||||
48.75
- 52.50
|
3,667 |
2.08
years
|
51.47 | - | ||||||||||
73.50
- 74.10
|
8,000 |
3.45
years
|
73.70 | - | ||||||||||
|
||||||||||||||
156,771 |
5.06
years
|
$ | 16.07 | $ | - |
12
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
|
196,713 | $ | 21.00 | - | |||||||||
Granted
|
- | - | |||||||||||
Exercised
|
- | - | - | ||||||||||
Forfeited
|
(39,943 | ) | 40.05 | - | |||||||||
Outstanding
at June 30, 2010
|
156,771 | 16.07 |
5.06
years
|
- | |||||||||
Vested
or expected to vest at June 30, 2010
|
156,771 | 1.07 |
5.06
years
|
- | |||||||||
Exercisable
at June 30, 2010
|
156,771 | $ | 1.07 |
5.06
years
|
- |
Expected Volatility. The
Company uses analysis of historical volatility to compute the expected
volatility of its stock options.
Expected Term. The expected
term is based on several factors including historical observations of employee
exercise patterns during the Company’s history and expectations of employee
exercise behavior in the future giving consideration to the contractual terms of
the stock-based awards.
Risk-Free Interest Rate. The
interest rate used in valuing awards is based on the yield at the time of grant
of a U.S. Treasury security with an equivalent remaining term.
Dividend Yield. The Company
has never paid cash dividends, and does not currently intend to pay cash
dividends, and thus has assumed a 0% dividend yield.
Pre-Vesting Forfeitures.
Estimates of pre-vesting option forfeitures are based on Company experience. The
Company will adjust its estimate of forfeitures over the requisite service
period based on the extent to which actual forfeitures differ, or are expected
to differ, from such estimates. Changes in estimated forfeitures will be
recognized through a cumulative catch-up adjustment in the period of change and
will also impact the amount of compensation expense to be recognized in future
periods.
As of
June 30, 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 June 30, 2010 there was $1,328,413 of total
unrecognized compensation cost related to unvested restricted
stock. That cost is expected to be recognized over a period of 2.5
years.
13
Principal
equity compensation transactions for the six months ended June 30, 2010 were as
follows:
For the
six months ended June 30, 2010, the Company issued 16,996 shares of common stock
to members of the Board of Directors for services rendered and recorded expenses
related to such issuances of $80,000.
On April
9, 2010, the Company awarded grants of restricted shares of Common Stock of
10,000 shares to Mark Westgate, the Company’s Chief Financial Officer, 6,667
shares to Dr Henry Esber, the Company’s Executive Vice President and Board
member and 5,000 shares to Edward Cox, the Company’s Vice President of investor
relations. The awards vest on April 9, 2011provided that each officer
remains in continuous uninterrupted service with the Company. The Company recorded compensation
expense of $33,201 during the six months ended June 30, 2010 for such
grants.
On May
24, 2010, at the Company’s annual stockholder meeting, the stockholders of the
Company approved an increase in the number of shares reserved for issuance under
the 2006 Plan. Upon such approval, the Company issued the following
restricted share grants to satisfy commitments to grant restricted shares
contingent upon such stockholder approval:
Dr.
Bassam Damaj, the Company’s Chief Executive Officer, was awarded a grant of
100,000 restricted shares of Common Stock. The grant will vest in
three installments of 20,000 shares, 33,333 shares and 46,667 shares on December
14, 2010, 2011 and 2012, respectively, provided that Dr. Damaj remain in
continuous and uninterrupted service with the Company. The Company
recorded compensation expense of $35,375 during the six months ended June 30,
2010 for such grant.
Vivian
Liu, the Company’s Chairman of the Board and Executive Vice President, was
awarded grants of restricted shares of Common Stock of 66,667 shares, 16,667
shares and 3,509 shares. The grant of 66,667 shares vested on
immediately upon issuance. The grants of 16,667 and 3,509 shares vest
on December 14, 2010 provided that Ms. Liu remains in continuous and
uninterrupted service with the Company. The Company recorded compensation
expense of $405,884 during the six months ended June 30, 2010 for such
grants.
The
Company awarded grants of restricted shares of Common Stock totaling 137,411
shares to certain Bio-Quant employees. The awards vest over various
time periods and require that the employees remain in continuous and
uninterrupted service with the Company. The Company recorded compensation
expense of $442,966 during the six months ended June 30, 2010 for such
grants.
The following table indicates where the
total stock-based compensation expense resulting from stock options and
restricted stock awards appears in the Unaudited Consolidated Statements of
Operations:
14
FOR THE THREE MONTHS
|
FOR THE SIX MONTHS
|
|||||||||||||||
ENDED JUNE 30,
|
ENDED JUNE 30,
|
|||||||||||||||
2010
|
2009
|
2010
|
2009
|
|||||||||||||
Research
and development
|
$ | 10,284 | $ | 47,515 | $ | 10,284 | $ | 61,576 | ||||||||
General
and administrative
|
1,040,090 | 284,731 | 1,184,643 | 511,658 | ||||||||||||
Stock-based
compensation expense
|
$ | 1,050,374 | $ | 332,246 | $ | 1,194,927 | $ | 573,234 |
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 six-month period ended June 30, 2010 is as
follows:
Common
Shares
|
Average
|
Average
|
|||||||
Issuable
upon
|
Exercise
|
Contractual
|
|||||||
Exercise
|
Price
|
Life
|
|||||||
Outstanding
at December 31, 2009
|
465,275 | $ | 15.45 |
1.03
years
|
|||||
Issued
|
- | ||||||||
Exercised
|
- | ||||||||
Expired
|
(214,380 | ) | $ | 16.65 | |||||
Outstanding
at June 30, 2010
|
250,895 | $ | 12.76 |
1.37
years
|
|||||
Exercisable
at June 30, 2010
|
250,895 | $ | 12.76 |
1.37
years
|
5. LOSS
PER SHARE
At June
30, 2010 and 2009, respectively, options to acquire 156,771 and 201,656 shares
of Common Stock, warrants to acquire 250,895 and 600,775 shares of Common Stock
and convertible securities convertible into 466,200 and 144,667 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 and six
months ended June 30, 2010 and 2009 was calculated as follows (net loss /
weighted average common shares outstanding):
15
FOR THE THREE MONTHS
|
FOR THE SIX MONTHS ENDED
|
|||||||||||||||
ENDED JUNE 30,
|
JUNE 30,
|
|||||||||||||||
2010
|
2009
|
2010
|
2009
|
|||||||||||||
Net
loss
|
$ | (4,278,648 | ) | $ | (1,426,158 | ) | $ | (13,516,104 | ) | $ | (741,386 | ) | ||||
Weighted
average common shares outstanding used for basic and diluted loss per
share
|
9,140,451 | 5,625,895 | 8,264,515 | 5,641,166 | ||||||||||||
Basic
and diluted loss per common share
|
$ | (0.47 | ) | $ | (0.25 | ) | $ | (1.64 | ) | $ | (0.13 | ) |
6. INTANGIBLE
ASSETS
Intangible
assets are listed below with associated accumulated amortization:
June
30,
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
|
(194,918 | ) | (14,994 | ) | ||||
Intangible
assets, net
|
$ | 3,965,082 | 4,145,006 |
The
Company is currently amortizing know-how over the expected useful life of 10
years and the trade name over the expected useful life of 20 years. Amortization
expense amounted to $179,924 for the six months ended June 30,
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 June 30 and thereafter is as
follows:
2011
|
$ | 359,860 | ||
2012
|
359,860 | |||
2013
|
359,860 | |||
2014
|
359,860 | |||
2015
|
359,860 | |||
Thereafter
|
2,165,782 | |||
Total
future amortization expense
|
$ | 3,965,082 |
16
7. CONVERTIBLE
NOTES PAYABLE
2010 Convertible
Notes
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 $8.70 per share (the “conversion price”), 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 $1.20 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.
On June
3, 2010, the conversion price was adjusted to $8.58 per share as a result of the
issuance of securities as discussed in Note 11 below.
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 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.
17
The 2008
Convertible Notes were payable in cash or convertible into shares of Common
Stock with the remaining principal amount initially convertible at $30 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 $1.20 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.
Conversion of 2008
Convertible Notes during 2009 and 2010
As
discussed in Note 14, the Company sold $350,000 of manufacturing equipment to
Warner Chilcott Company, Inc.
(“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 $3.45 per share. As
such, the Company issued 43,960 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 $3.45 per share. As
such, the Company issued 32,710 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 $2.40 per share. As
such, the Company issued 125,559 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 $2.25 per
share. As such, the Company issued 157,915 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 $2.40 per share. As
such, the Company issued 146,230 shares of Common Stock to the note holders in
repayment of such $350,000 principal amount plus interest.
18
On
October 15, 2009, the Company agreed to convert $250,000 of the outstanding 2008
Convertible Notes to Common Stock at a price of $2.25 per share. As
such, the Company issued 111,435 shares of Common Stock to the note holders in
repayment of such $250,000 principal amount plus interest.
On
November 10, 2009, the Company issued convertible notes in the aggregate
principal amount of $750,000 under terms substantially similar to 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 $30.00 to $2.10 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 361,319 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 $30.00 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 $7.50 per share. As
such, the Company issued 53,333 shares of Common Stock to the note holders in
repayment of such $397,988 principal amount plus interest.
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.
The Company recognized a debt inducement
charge in interest expense for the differential between the original conversion
rate of $30.00 per share and the $7.50 price listed above. Non-cash
interest expense recognized with respect to this conversion was $1,200,000
during the six months ended June 30, 2010.
19
8. NOTES PAYABLE
Former
Bio-Quant Shareholders’ Notes
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
accrued 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 provided that
the principal amounts and all interest thereunder were payable by the Company in
cash or, at the Company’s option, in NexMed Shares, which would be valued at the
fixed price of $2.52 per share. The Merger Agreement provided that if
the Company repaid the Notes in NexMed Shares, the total number of NexMed Shares
issuable to Bio-Quant shareholders could not exceed 19.99% of outstanding NexMed
Shares at the Effective Time unless the Company received stockholder approval to
do so in accordance with applicable rules of the NASDAQ Stock
Market. At its May 24, 2010 meeting of stockholders, the Company
received such stockholder approval for the issuance of up to approximately 4.2
million NexMed Shares in repayment of the Notes. 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.
On January 11, 2010, the Company repaid
$261,016 of outstanding principal of the Notes through the issuance of Common
Stock at $2.52 per share, which is the fixed payment price pursuant to the terms
of the Notes. As such, the Company issued 140,500 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 $2.52 per share, which is the fixed payment price pursuant to
the terms of the Notes. As such, the Company issued 862,710 shares of
Common Stock to the note holders in repayment of such $1,969,185 principal
amount plus interest.
On May 24, 2010, Company officers who are also holders of
Bio-Quant Notes agreed to receive approximately 2,057,000 Shares in repayment of
approximately $6.2 million of principal and interest owed which results in an
effective repayment price of $3.00 per share.
On June 21, 2010, the Notes were repaid
in full with the issuance of 3,639,410 shares of common stock to repay the
remaining outstanding principal amount of $10,159,825 plus
interest.
The Company recognized a beneficial
conversion charge for the differential between the original conversion rates of
$2.52 and $3.00 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 to (?) non-cash interest expense recognized with respect to the Notes for
the six months ended June 30, 2010 was $6,139,741.
2010 Promissory
Notes
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 $5.55 per Share, with
the conversion prices ranging from $5.40 to $6.00 per Share.
20
On March
17, 2010, the 2010 Notes were repaid in full with the issuance of 415,504 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 $5.40 to $6.00 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 six months ended June 30, 2010 as a result of the
conversion.
9. LINES OF
CREDIT
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 $255,000 cash deposit from the Company which is classified as restricted
cash on the accompanying consolidated balance sheet at June 30,
2010. The credit line expires on March 7, 2011 and bears interest at
the rate of 4.25% per annum or 1% above the Prime Rate.
On April 12, 2010, Bio-Quant entered
into a Loan and Security agreement with Torrey Pines Bank for a revolving line
of credit (“credit line”) in the amount of $250,000. The credit line
is secured by a $278,000 cash deposit from the Company which is classified as
restricted cash on the accompanying consolidated balance sheet at June 30,
2010. The credit line expires on April 12, 2011 and bears interest at
the rate of 2.6% per annum.
As of June 30, 2010, $401,000 had been
drawn down on the credit lines and is recorded as short-term borrowing on the
accompanying unaudited Consolidated Balance Sheet.
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 June 30, 2010, the Company has
accrued $908,106 in deferred compensation.
11. COMMON
STOCK
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 June 30, 2010, the Company had sold an aggregate
of 518,264 shares of common stock under the Sales Agreement at a weighted
average sales price of approximately $6.73 per share, resulting in offering
proceeds of approximately $3.3 million, net of sales
commissions.
21
12. RELATED
PARTY TRANSACTIONS
Approximately
63% of the Bio-Quant notes payable described in Note 8 were held by executives
of the Company. As discussed in Note 8 above, such notes payable were
repaid in full on June 21, 2010 with the issuance of Common Stock.
Prior to
the 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, 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.
13. 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
limitation occurred when the Bio-Quant notes were 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.
22
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 June 30, 2010.
14. 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”).
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 the
Company 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 the 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, $5,100 and $4,250 was being recognized as
revenue for the six months ended June 30, 2010 and 2009,
respectively. The balance of $87,550 is recorded as deferred revenue
on the unaudited Consolidated Balance Sheet at June 30, 2010.
23
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. 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.
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.
24
15. COMMITMENTS
AND CONTINGENCIES
Employment
Agreement
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, 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 without cause or he resigns for good reason, the President and Chief
Executive Officer will be paid a lump sum amount equal to his base salary for a
12-month period following such 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 payments equal to $300,000.
16. 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.
25
Segment
information for the six months ended June 30, 2010 follows:
NexACT® Drug
Delivery
|
Bio-Quant
CRO
|
Other
Corporate
Not
Allocated to
Segments
|
Consolidated
Total
|
|||||||||||||
Revenue
|
$ | 35,100 | $ | 2,812,679 | $ | 68,900 | $ | 2,916,679 | ||||||||
Cost
of Services
|
- | 2,046,399 | - | 2,046,399 | ||||||||||||
Gross
Profit
|
$ | 2,550 | $ | 766,280 | $ | - | $ | 870,280 | ||||||||
Costs
and expenses
|
||||||||||||||||
Research
and development
|
916,743 | - | - | 916,743 | ||||||||||||
General
and administrative
|
- | 1,593,627 | 3,286,309 | 4,879,936 | ||||||||||||
Loss
from operations
|
$ | (914,193 | ) | $ | (827,347 | ) | $ | (3,286,309 | ) | $ | (4,926,399 | ) | ||||
Total
assets
|
$ | - | $ | 15,045,423 | $ | 9,435,240 | $ | 24,480,663 | ||||||||
Capital
expenditures
|
$ | - | $ | 295,052 | $ | 1,804 | $ | 296,856 |
26
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 14 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”), one of the largest
specialty biotechnology contract research organizations (“CROs”) 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 performs both in
vitro and in
vivo pharmacology, pharmacokinetics (PK) and toxicology studies 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.
27
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.
Growth
Strategy
We are
currently focusing our efforts on new and patented pharmaceutical products
mostly 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 key partnership opportunities for both our NexACT technology and
pipeline products. Given the increasing number of licensing inquiries that we
have received, we hired two senior business development executives in May 2010
to broaden the partnership opportunities. Moreover, we believe that
we can enhance our business development efforts by offering potential partners
clearly defined regulatory paths for our products under
development. Towards that end, we will continue to work closely with
our regulatory and clinical consultants, and meet with the FDA in order to
obtain Special Protocol Assessments (SPA) for our clinical
studies. When the FDA grants SPAs for our studies, the agency cannot
change the clinical endpoints at a later date.
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.
28
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, subcutaneous, ocular and
rectal delivery of classes of drugs for these and other
indications.
Additionally,
with Bio-Quant as our subsidiary, we have been able to accelerate our early
stage product development programs by utilizing our in-house capabilities to
perform in vitro and
in vivo pharmacology,
pharmacokinetics (PK) and toxicology studies.
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, we
believe the product has demonstrated potential 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 an 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.
29
In May
2010, we announced that we obtained an IND number for RayVa, our topical
alprostadil-based treatment for Raynaud’s syndrome, which refers to a disorder
in which the fingers or toes (digits) suddenly experience decreased blood
circulation, and is characterized by color changes of the skin of the digits
upon exposure to cold or emotional stress. Given the disease characteristics,
Raynaud’s syndrome is an appealing product opportunity for us and one that we
believe can benefit strongly from the active ingredient in
Vitaros. We met with the FDA in July 2010 to discuss the proposed
regulatory path for our product. We expect to finalize the clinical
development program in the third quarter of 2010.
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 and $5 million in milestones in
2008. In addition, we were eligible to receive royalties based upon
the level of sales achieved.
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).
Pursuant
to the termination agreement, 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.
30
We have completed our analysis of the
two pivotal Phase 3 studies completed by Novartis. We are sharing the
clinical database and our conclusion with potential partners interested in
licensing MycoVa (formerly NM100060) for further development.
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.
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.
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.
31
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 to be completed and included in our response to the
Notice. On June 23, 2010, we announced that Health Canada issued The Screening Acceptance Letter (the
“Acceptance Letter”) in connection with our NDS. The Acceptance
Letter confirmed that the CMC response filed by us in April 2010 was acceptable
for the final, 150-day review cycle. Based on the date of acceptance,
a final approval decision regarding the approvability of the product for
marketing in Canada is expected by the end of November 2010. There is no assurance that
we will receive a favorable decision.
For
Europe, we are currently pursuing a decentralized filing strategy. Our intention
is to pursue filing of the Marketing Authorization Application (“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.
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.
32
Bio-Quant
CRO Business
Bio-Quant
performs both in vitro
and in vivo
pharmacology, pharmacokinetics (PK) and toxicology studies 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.
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 drug development
problems.
Bio-Quant
has two labs and housing facilities along with an experienced scientific staff
of 19 employees.
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, Capital Resources and
Financial Condition.
We have
experienced net losses and negative cash flows from operations each year since
our inception. Through June 30, 2010, we had an accumulated deficit
of $185,247,966. 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.
33
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 June 30, 2010, we had cash and cash
equivalents of approximately $4.8 million as compared to $480,000 at December
31, 2009. During the first half 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. We also received net
proceeds of approximately $3.3 million from the sale of Common Stock as
discussed in Note 11 of the Notes to the Unaudited Consolidated Financial
Statements. The receipt of this cash during the first half of 2010
was offset by our cash
used. Our net cash outflow during the first half of 2010 was
approximately $2.6 million which includes approximately $437,000 in proceeds
received during the first half of the year from the sale of our New Jersey net
operating losses in 2009. During the first half of the year our
Bio-Quant CRO had a net cash outflow of approximately $157,000. Our
administrative overhead, including public company expenses, is approximately
$160,000 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 and Common Stock sold as discussed in Notes 7 and 11
of the Notes to the Unaudited Consolidated Financial Statements, the special
meeting of our stockholders held in March 2010, and also fees related to the
acquisition of Bio-Quant in 2009. We also spent approximately
$904,000 for the development of our NexACT technology and related pipeline
products. During the first half of the year, 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, $143,000
in legal fees related to new patent applications for our NexACT technology and
$202,000 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.
We
anticipate that our current cash reserves of approximately $4 million as of the
date of this report will provide us with sufficient cash to fund our operations
into the first quarter of 2011. This projection is based on our
current administrative overhead, including public company expenses, of
approximately $160,000 per month together with our planned expenditures related
to continued research and development expenses related to the NexACT drug
delivery technology. Additionally the Bio-Quant CRO business has been growing at
a much slower pace than anticipated as Dr. Damaj, our CEO, has focused his
efforts on the future development of the NexACT drug delivery technology rather
than the growth of the Bio-Quant CRO business. We expect Bio-Quant to
be self sustaining and cash flow positive in 2011 as we re-start our efforts to
grow the business organically beyond the work being done to support the
expansion of our NexACT®
technology. In connection with our continuous effort to grow
the CRO business we have hired two senior executives; a vice president of
business development and a vice president of research and development to
strengthen the Bio-Quant CRO management team. In addition, the
Bio-Quant CRO business will require funding from our current cash reserves as
the Bio-Quant CRO continues to divert its existing resources and capacity to
support the expansion of our NexACT®
technology into the areas of oncology, inflammation, immunology, and
metabolic diseases in addition to new delivery routes of our NexACT®
technology. During the six-month period ended June 30, 2010,
approximately 14% of the studies performed by Bio-Quant were in support of the
expansion of our NexACT®
technology.
34
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.
Comparison
of Results of Operations Between the Three Months Ended June 30, 2010 and
2009.
Revenue. We
recorded $1,470,927 in revenue during the second quarter of 2010, as compared to
$102,613 in revenue during the second 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 14 to the unaudited consolidated financial
statements. The 2010 revenue is almost entirely attributable to the
sales of CRO services by our Bio-Quant CRO. We 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 second
quarter of 2010 and 2009 were $477,566 and $716,453,
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 in addition to new delivery routes of our NexACT®
technology.
General and Administrative
Expenses. Our general and administrative expenses were
$2,640,400 during the second quarter of 2010 as compared to $694,749 during the
same period in 2009. The increase is due to approximately $1.1
million of stock compensation expense recorded during the second quarter of 2010
as restricted share grants contingent upon stockholder approval of an increase
in the number of authorized shares in the NexMed, Inc. 2006 Stock Incentive Plan
(the “Plan”) were awarded in May 2010 upon approval of such shares as discussed
in Note 3 of the unaudited consolidated financial
statements. Additionally, there was an increase in expenses in 2010
related to the Bio-Quant CRO business which was acquired in December
2009.
35
Interest Expense,
Net. We had net interest expense of $1,609,657 during the
second quarter of 2010, as compared to $117,569 during the same period in
2009. The increased interest expense is the result of non-cash
interest expense recognized on the beneficial conversion feature of the notes
payable as discussed in Note 8 to the unaudited consolidated financial
statements. Non cash interest expense was $1,599,981 and $44,170 for
the second quarter ended June 30, 2010 and 2009, respectively.
Net Loss. The net
loss was $4,278,648 or $0.47 per share in the second quarter of 2010 as compared
to net loss of $117,569 or $0.25 per share during the same period in
2009. The increase in net loss is primarily attributable to the
increased general and administrative expenses and non-cash interest charges as
discussed above.
Comparison
of Results of Operations Between the Six Months Ended June 30, 2010 and
2009.
Revenue. We
recorded $2,916,679 in revenue during the first half of 2010, as compared to
$2,569,283 in revenue during the first half of 2009. The 2009
revenue is primarily attributable to the sale of the U.S. rights of Vitaros® to
Warner as discussed in Note 14 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 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
half of 2010 and 2009 were $903,959 and $1,318,819,
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 in addition to new delivery routes of our NexACT®
technology.
General and Administrative
Expenses. Our general and administrative expenses were
$4,879,936 during the first half of 2010 as compared to $1,785,796 during the
same period in 2009. The increase is due to approximately $1.1
million of stock compensation expense recorded during the second quarter of 2010
as restricted share grants contingent upon stockholder approval of an increase
in the number of authorized shares in the NexMed, Inc. 2006 Stock Incentive Plan
(the “Plan”) were awarded in May 2010 upon approval of such shares as discussed
in Note 3 of the unaudited consolidated financial
statements. Additionally, there was an increase in expenses in 2010
related to the Bio-Quant CRO business which was acquired in December
2009.
36
Interest Expense,
Net. We had net interest expense of $8,589,704 during the
first half of 2010, as compared to $206,054 during the same period in
2009. The increased interest expense is the result of non-cash
interest expense recognized on the beneficial conversion feature of the
convertible mortgage notes and notes payable as discussed in Notes 7 and 8 to
the unaudited consolidated financial statements. Non cash interest
expense was $8,530,999 and $51,762 for the six months ended June 30, 2010 and
2009, respectively.
Net Loss. The net
loss was $13,516,104 or $1.64 per share in the first half of 2010 as compared to
net loss of $741,386 or $0.13 per share during the same period in
2009. The increase in 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 which increased revenue as discussed in Note 14 to the unaudited
consolidated financial statements.
ITEM
3.
|
QUALITATIVE
AND QUANTITATIVE DISCLOSURES ABOUT MARKET
RISK
|
There have been no material changes to
our exposures to market risk since December 31, 2009.
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 31, 2010.
37
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
|
1.1
|
Sales
Agreement, dated as of April 21, 2010, by and between the Company and
Brinson Patrick Securities Corporation (incorporated by reference to
Exhibit 1.1 of the Company’s Current Report on Form 8-K, filed on April
21, 2010).
|
|
3.1
|
Certificate
of Change (incorporated by reference to Exhibit 3.1 of the Company’s
Current Report on Form 8-K, filed on June 17, 2010).
|
|
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.
|
38
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 12, 2010
|
/s/
Mark Westgate
|
Mark
Westgate
|
|
Vice
President and Chief Financial
|
|
Officer
|
39
EXHIBIT
INDEX
1.1
|
Sales
Agreement, dated as of April 21, 2010, by and between the Company and
Brinson Patrick Securities Corporation (incorporated by reference to
Exhibit 1.1 of the Company’s Current Report on Form 8-K, filed on April
21, 2010).
|
|
3.1
|
Certificate
of Change (incorporated by reference to Exhibit 3.1 of the Company’s
Current Report on Form 8-K, filed on June 17, 2010).
|
|
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.
|
40