SEELOS THERAPEUTICS, INC. - Annual Report: 2006 (Form 10-K)
UNITED
STATES SECURITIES AND EXCHANGE COMMISSION
WASHINGTON,
DC 20549
FORM
10-K
(Mark
One)
x |
ANNUAL
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE
ACT OF
1934
|
For
the
fiscal year ended December
31, 2006
OR
o |
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE
ACT OF
1934
|
For
the
transition
period
from __________
to
___________
Commission
file number 0-22245
NEXMED,
INC.
(Exact
Name of Registrant as Specified in Its Charter)
Nevada
|
87-0449967
|
(State
or Other Jurisdiction of Incorporation or Organization)
|
(I.R.S.
Employer Identification No.)
|
89
Twin Rivers Drive, East Windsor, NJ 08520
(Address
of Principal Executive Offices) (Zip Code)
(609)
371-8123
(Registrant’s
telephone number, including area code)
Securities
registered pursuant to Section 12(b) of the Act:
Title
of Each Class
|
Name
of Exchange on Which Registered
|
Common
Stock, par value $.001
|
The
NASDAQ Capital Market
|
Indicate
by check mark if the registrant is a well-known seasoned issuer, as defined
in
Rule 405 of the Securities Act. Yes o No x
Indicate
by check mark if the registrant is not required to file reports pursuant to
Section 13 or Section 15(d) of the Act. Yes o No x
Indicate
by check mark whether the registrant (1) has filed all reports required to
be
filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 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 if disclosure of delinquent filers pursuant to Item 405 of
Regulation S-K is not contained herein, and will not be contained, to the best
of registrant’s knowledge, in definitive proxy or information statements
incorporated by reference in Part III of this Form 10-K or any amendment to
this
Form 10-K. x
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer or a non-accelerated filer. See definition of “accelerated
filer and large accelerated filer” in Rule 12b-2 of the Exchange Act (check
one): Large accelerated filer o Accelerated filer o
Non-accelerated filer x
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Act).
Yes
o
No
x
As
of
March 21, 2007, 80,354,714 shares of the common stock, par value $.001, of
the
registrant were outstanding. and the aggregate market value of the common stock
held by non-affiliates, based upon the last sale price of the registrant’s
common stock on June 30, 2006, was approximately $49 million.
DOCUMENTS
INCORPORATED BY REFERENCE
Portions
of our Proxy Statement to be delivered to our stockholders in connection with
the Company’s 2007 Annual Meeting of Stockholders (the “2007 Proxy Statement”)
are incorporated by reference into Part III of this Report.
NEXMED,
INC.
INDEX
TO
ANNUAL REPORT ON FORM 10-K FILED WITH
THE
SECURITIES AND EXCHANGE COMMISSION
YEAR
ENDED DECEMBER 31, 2006
ITEMS
IN FORM 10-K
|
Page
|
|
PART
I.
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3
|
|
Item
1.
|
BUSINESS
|
3
|
|
||
Item
1A.
|
RISK
FACTORS
|
7
|
|
||
Item
1B.
|
UNRESOLVED
STAFF COMMENTS
|
11
|
|
||
Item
2.
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PROPERTIES
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11
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||
Item
3.
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LEGAL
PROCEEDINGS
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12
|
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||
Item
4.
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SUBMISSION
OF MATTERS TO A VOTE OF SECURITY HOLDERS
|
12
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PART
II.
|
12
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|
|
||
Item
5.
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MARKET
FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER
PURCHASES OF EQUITY SECURITIES
|
12
|
|
||
Item
6.
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SELECTED
FINANCIAL DATA
|
13
|
|
||
Item
7.
|
MANAGEMENT’S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
|
14
|
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||
Item
7A
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QUANTITATIVE
AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
|
21
|
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||
Item
8.
|
FINANCIAL
STATEMENTS AND SUPPLEMENTARY DATA
|
21
|
|
||
Item
9.
|
CHANGES
IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL
DISCLOSURE
|
48
|
|
||
Item
9A.
|
CONTROLS
AND PROCEDURES
|
48
|
|
||
Item
9B.
|
OTHER
INFORMATION
|
49
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||
PART
III.
|
49
|
|
|
||
Item
10.
|
DIRECTORS,
EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
|
49
|
|
||
Item
11.
|
EXECUTIVE
COMPENSATION
|
49
|
|
||
Item
12.
|
SECURITY
OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED
STOCKHOLDER MATTERS
|
49
|
|
||
Item
13.
|
CERTAIN
RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR
INDEPENDENCE
|
50
|
|
||
Item
14.
|
PRINCIPAL
ACCOUNTING FEES AND SERVICES
|
50
|
|
||
PART
IV.
|
50
|
|
|
||
Item
15.
|
EXHIBITS,
FINANCIAL STATEMENT SCHEDULES
|
50
|
2
PART
I.
ITEM
1. BUSINESS.
Some
of
the statements contained in this Report discuss future expectations, contain
projections of results of operations or financial condition or state other
“forward-looking” information. Those statements include statements regarding the
intent, belief or current expectations of the Company and its management team.
Prospective investors are cautioned that any such forward-looking statements
are
not guarantees of future performance and involve risks and uncertainties, and
that actual results may differ materially from those projected in the
forward-looking statements. These risks and uncertainties include but are not
limited to, those risks and uncertainties set forth under the heading “Factors
That Could Affect Our Future Results” in item 1A of this Report. In light of the
significant risks and uncertainties inherent in the forward-looking statements
included in this Report, the inclusion of such statements should not be regarded
as a representation by us or any other person that our objectives and plans
will
be achieved.
General
We
are a
Nevada corporation and have been in existence since 1987. Since 1994, we have
positioned ourselves as a pharmaceutical and medical technology company with
a
focus on developing and commercializing therapeutic products based on
proprietary delivery systems. We are currently focusing our efforts on new
and
patented topical pharmaceutical products based on a penetration enhancement
drug
delivery technology known as NexACT®,
which
may enable an active drug to be better absorbed through the skin.
The
NexACT®
transdermal drug delivery technology is designed to enhance the absorption
of an
active drug through the skin, overcoming the skin's natural barrier properties
and enabling high concentrations of the active drug to rapidly penetrate the
desired site of the skin or extremity. Successful application of the
NexACT®
technology would improve therapeutic outcomes and reduce systemic side effects
that often accompany oral and injectable medications. We intend to continue
our
efforts developing topical treatments based on the application of
NexACT®
technology to drugs: (1) previously approved by the FDA, (2) with proven
efficacy and safety profiles, (3) with patents expiring or expired and (4)
with
proven market track records and potential.
We
have
applied the NexACT®
technology to a variety of compatible drug compounds and delivery systems,
and
are in various stages of developing new topical treatments for sexual
dysfunction and nail fungus.
On
September 15, 2005, we announced an exclusive global licensing agreement with
Novartis International Pharmaceutical Ltd. (“Novartis”), for NM100060, our
proprietary nail lacquer treatment for onychomycosis (nail fungal infection).
Under the agreement, Novartis acquired the exclusive worldwide rights to
NM100060 and has assumed all further development, regulatory, manufacturing
and
commercialization responsibilities as well as costs. Novartis agreed to pay
us
up to $51 million in upfront and milestone payments on the achievement of
specific development and regulatory milestones, including an initial cash
payment of $4 million at signing. In addition, we are eligible to receive
royalties based upon the level of sales achieved. On
January 31, 2007, we announced
that Novartis, had commenced dosing of patients in the Phase 3 clinical trials
for NM100060. The
Phase
3 program for NM100060 consists of two pivotal, randomized, double-blind,
placebo-controlled studies. The parallel group studies are designed to assess
the efficacy, safety and tolerability of NM100060 in patients with mild to
moderate toenail onychomycosis. Approximately 1,000 patients will participate
in
the two studies, which will take place in the U.S., Europe, Canada and Iceland.
The Phase 3 program is expected to be competed during the first half of 2008.
The
most
advanced of our products under development is Alprox-TD®
which
is
an alprostadil-based cream treatment intended for patients with erectile
dysfunction. In December 2002, we completed our two pivotal Phase 3 studies
for
Alprox-TD®
that
tested over 1,700 patients at 85 sites throughout the U.S. We announced in
2006
that we have developed a room temperature stable Alprox-TD®.
We
believe the opportunity to distribute a non-refrigerated alprostadil product
will be attractive for potential licensing partners. However, even if we attract
a potential partner, consummation of a commercialization arrangement is subject
to complex negotiations of contractual relationships, and we may not be able
to
consummate such relationship on a timely basis, or on terms acceptable to us.
3
On
July
1, 2004, we entered into a license, supply and distribution agreement with
Schering AG, Germany (“Schering”). This agreement provided Schering with
exclusive commercialization rights to Alprox-TD®
in
approximately 75 countries outside of the U.S. On June 20, 2006, Schering
elected to terminate the agreement without cause. We believe that
Alprox-TD was no longer a strategic fit for Schering due to its merger
with Bayer AG. In connection with the termination, Schering paid us a
termination fee of 500,000 Euros or approximately $627,000.
We
are
pursuing a regulatory strategy for Alprox-TD®
which
includes the filing of the New Drug Application (“NDA”) in the United
States, New Drug Submission in Canada, and Marketing Authorization Application
in Europe during first half of 2007. With input from independent regulatory
consultants and legal counsel, we believe the safety data of Alprox-TD
based on our clinical database of over 3,000 patients is sufficient for
filing the NDA and, therefore, we do not need to
conduct a 12-month open-label study as indicated by ICH (International
Conference on Harmonisation of Technical Requirements for Registration of
Pharmaceuticals for Human Use) guidance. We believe our strategy is aggressive
but has a reasonable likelihood of success. We anticipate that the cost to
prepare all of the relevant dossiers and assemble the regulatory approval
applications in the U.S., Canada and Europe will be approximately $1.9 million.
However, we cannot be certain that our applications with the appropriate
regulatory authorities will be accepted for filing, and it is also possible
that
even if our applications have been accepted, we may not be successful in
convincing the regulatory authorities to accept our position.
On
February 21, 2007, the Canadian regulatory authority, Health Canada, informed
us
that the safety data on Alprox-TD that we have compiled to date is sufficient
for the New Drug Submission application (“NDS”) to be filed and accepted for
review in Canada. As such, the lack of a completed 12-month open label safety
study will not preclude Health Canada from accepting and reviewing our NDS
in
Canada.
In
our
ongoing discussions with several potential licensing partners, we have continued
to discuss conducting the open-label study as part of risk management for the
product whereby we would have the twelve-month safety data available should
the
FDA not accept our position of filing the NDA with our current safety data.
We
would require additional funding in connection with conducting an open-label
study, as we do not have the finances available at this time to conduct such
study, which is estimated to cost $5 to $8 million. Such funding through a
new
partnership and/or other financing opportunities may not be available on
acceptable terms, if at all.
Alprox-TD®
has been
selling in China and in Hong Kong since October 2001 and April 2002,
respectively, under the Befar trademark. The product is manufactured and
marketed by a local affiliate of Vergemont International Limited, our Asian
licensee. We are entitled to receive from our Asian licensee very modest royalty
payments in connection with the distribution of Befar®
in China
and other Asian markets if and when Befar®
is
approved for marketing in such other markets. The sale of Befar®
has been
limited for several reasons including that China has a limited number of
patients who can afford erectile dysfunction treatments.
We
are
also developing Femprox®,
which
is an alprostadil-based cream product intended for the treatment of female
sexual arousal disorder. We have completed one U.S. Phase 2 study for
Femprox®,
and
also a 400-patient study for Femprox®
in
China, where the cost for conducting clinical studies is significantly lower
than in the U.S. We have been in contact with several potential co-development
partners. We do not intend to conduct additional studies for this product until
we have secured a co-development partner.
On
December 15, 2005, we announced the departure of Dr. Y. Joseph Mo as President
and Chief Executive Officer of the Company. On January 12, 2006, we announced
the appointment of Richard J. Berman, who has served on the Board of Directors
since 2002, as Chief Executive Officer of the Company. The Board of Directors
mandated Mr. Berman to improve the Company’s financial condition and focus its
development efforts. On January 29, 2007, we announced the appointment of Dr.
David S. Tierney to the Board of Directors, increasing our Board to six
members.
During
2006, we significantly reduced our monthly cash expenses by streamlining our
operations and met our goal of achieving a monthly cash “burn rate” of
approximately $500,000 by mid-2006. We have consolidated our operations into
our
East Windsor facility which was originally designed for manufacturing with
offices and laboratories. The consolidation in facilities resulted in savings
to
us of approximately $600,000 per year. Further, we reduced our staff by
approximately 50%, which, with reductions made in December 2005 and March 2006,
we expect will result in annual savings of approximately $2.8 million from
pre-2006 levels.
4
We
have
also analyzed our product pipeline for opportunities to license or divest some
of our products under development, with the goal of focusing our attention
on
product opportunities that would replicate the model of our licensed anti-fungal
nail treatment. We have decided to concentrate our development efforts on our
non-patch topical products.
In
December 2006, we completed a private placement of common stock and warrants
which yielded gross proceeds to us of approximately $8.6 million. The successful
completion of this placement significantly strengthened our cash position,
giving us cash reserves to sustain our operations through approximately the
end
of 2007 if we are unable to
renegotiate our $5 million of notes due in 2007 to be able to postpone repayment
or repay amounts in equity rather than cash. However we are confident that
we
can renegotiate the notes, sell our facility in East Windsor, NJ or rely on
expected milestone payments from our Novartis licensing agreement to fund the
repayment of the notes. If we are able to achieve any one of the aforementioned
objectives then we project that our cash reserves of $10.9 million as of the
date of this report are sufficient to sustain our operations for approximately
19 months at the current burn rate of approximately $450,000 per month. There
is
no assurance that we will be able to renegotiate our notes on terms acceptable
to us, if at all. Further, there is no assurance that milestone payments from
our Novartis licensing agreement will be earned or that we will be able to
sell
our facility in East Windsor, NJ.
Research
and Development
Our
research and development expenses for the years ended December 31,2006, 2005
and
2004 were $5,425,137, $11,222,099 and $10,684,477, respectively. Since January
1, 1994, when we repositioned ourselves as a medical and pharmaceutical
technology company, through December 31, 2006 we have spent $86,466,401 on
research and development.
Patents
We
have
twelve U.S. patents either acquired or received out of a series of patent
applications that we have filed in connection with our NexACT®
technology and our NexACT-based products under development. To further
strengthen our global patent position on our proprietary products under
development, and to expand the patent protection to other markets, we have
filed
under the Patent Cooperation Treaty, corresponding international applications
for our issued U.S. patents and pending U.S. patent applications.
The
following table identifies our twelve U.S. patents issued for NexACT®
technology and/or our NexACT®-based
products under development, and the year of expiration for each
patent:
Patent
Name
|
Expiration
Date
|
|
Biodegradable
Absorption Enhancers
|
2008
|
|
Biodegradable
Absorption Enhancers
|
2009
|
|
Compositions
and Methods for Amelioration of Human Female Sexual
Dysfunction
|
2017
|
|
Topical
Compositions for PGE1 Delivery
|
2017
|
|
Topical
Compositions for Non-Steroidal Anti-Inflammatory Drug
Delivery
|
2017
|
|
Medicament
Dispenser
|
2019
|
|
Crystalline
Salts of dodecyl 2-(N, N-Dimethylamino) *
|
2019
|
|
Topical
Compositions Containing Prostaglandin E1
|
2019
|
|
CIP:
Topical Compositions Containing Prostaglandin E1
|
2019
|
|
Prostaglandin
Composition and Methods of Treatment of Male Erectile
Dysfunction
|
2020
|
|
CIP:
Prostaglandin Composition and Methods of Treatment of Male Erectile
Dysfunction
|
2020
|
|
Topical
Stabilized Prostaglandin E Compound Dosage Forms
|
2023
|
5
*
Composition
of matter patent on our NexACT®
technology which is included in all of our current products under
development
In
July
2006, we announced a Notice of Allowance from the U.S. Patent & Trademark
Office for our U.S. patent application entitled, “Prostaglandin Compositions
& Methods of Treatment for Male Erectile Dysfunction.” The patent, when
issued, provides coverage until 2017. In addition, we have over 200
International patents and U.S. and International patent applications pending.
While
we
have obtained patents and have several patent applications pending, the extent
of effective patent protection in the U.S. and other countries is highly
uncertain and involves complex legal and factual questions. No consistent policy
addresses the breadth of claims allowed in or the degree of protection afforded
under patents of medical and pharmaceutical companies. Patents we currently
own
or may obtain might not be sufficiently broad to protect us against competitors
with similar technology. Any of our patents could be invalidated or
circumvented.
While
we
believe that our patents would prevail in any potential litigation, the holders
of competing patents could determine to commence a lawsuit against us and even
prevail in any such lawsuit. Litigation could result in substantial cost to
and
diversion of effort by us, which may harm our business. In addition, our efforts
to protect or defend our proprietary rights may not be successful or, even
if
successful, may result in substantial cost to us.
Segment
and Geographic Area Information
You
can
find information about our business segment and geographic areas of business
in
Note 17 of the Notes to Consolidated Financial Statements.
Employees
As
of
March 21, 2007, we had 18 full time employees, 2 of whom have a Ph.D degree,
2
of whom are executive management and 12 of whom are engaged in research and
development activities. We also rely on a number of consultants. None of our
employees is represented by a collective bargaining agreement. We believe that
we have a good relationship with our employees.
Executive
Officers of the Registrant
The
Executive Officers of the Company are set forth below.
Name
|
Age*
|
Title
|
||
Richard
J. Berman
|
64
|
Director,
President and Chief Executive Officer
|
||
Vivian
H. Liu
|
45
|
Executive
Vice President and Chief Operating Officer and
Secretary
|
||
Mark
Westgate
|
37
|
Vice
President and Chief Financial Officer and
Treasurer
|
*As
of
March 1, 2007
Richard
J. Berman is, and has been, our President and Chief Executive Officer since
January 2006. Since 2001, Mr. Berman has served as a Director and/or Chairman
of
several public and private companies. Mr. Berman currently serves as Chairman
of
National Investment Managers, a public company in pension administration and
investment management; Chairman of Candidate Resources, a private company
delivering HR services over the web, and Chairman of Fortress Technology Systems
(homeland security). Mr. Berman is a director of eight public companies: Dyadic
International, Inc.(AMEX: DIL), Broadcaster, Inc.
(OTC:
BCSR.OB),
Internet Commerce Corporation (Nasdaq:
ICCA),
MediaBay, Inc.
(Nasdaq: MBAY),
NexMed,
Inc., National Investment Managers
(OTC:
NIVM.OB),
Advaxis, Inc.
(OTC:
ADXS.OB),
and
NeoStem, Inc
(OTC:
NEOI.OB).
From
1998-2000, he was employed by Internet Commerce Corporation as Chairman and
CEO.
Previously, Mr. Berman worked at Goldman Sachs; was Senior Vice President of
Bankers Trust Company, where he started the M&A and Leveraged Buyout
Departments; created the largest battery company in the world by merging
Prestolite, General Battery and Exide to form Exide (NYSE); helped create what
is now Soho (NYC) by developing five buildings; and advised on over $4 billion
of M&A transactions. He is a past Director of the Stern School of Business
of NYU where he obtained his BS and MBA. He also has US and foreign law degrees
from Boston College and The Hague Academy of International Law,
respectively.
6
Vivian
H.
Liu is, and has been, our Executive Vice President and Chief Operating Officer
since January 2006, our Secretary since 1995. Ms. Liu served as the Company's
Vice President of Corporate Affairs from September 1995 until December 2005,
Acting Chief Executive Officer from December 2005 until January 2006, Chief
Financial Officer from January 2004 until December 2005, Acting Chief Financial
Officer from 1999 to January 2004 and Treasurer from September 1995 through
December 2005. In 1994, while the Company was in a transition period, Ms. Liu
served as Chief Executive Officer. From 1985 to 1994, Ms. Liu was a business
and
investment adviser to the government of Quebec and numerous Canadian companies
with respect to product distribution, technology transfer and investment issues.
Ms. Liu received her MPA in International Finance from the University of
Southern California and her BA from the University of California,
Berkeley.
Mark
Westgate is, and has been, our Vice President, Chief Financial Officer and
Treasurer since December 2005. From March 2002 to December 2005, Mr. Westgate
served as our Controller. He has over fifteen years of public accounting and
financial management experience. From August 1998 to March 2002, Mr. Westgate
served as Controller and Director of Finance for Lavipharm Laboratories Inc,
a
company specializing in drug delivery and particle design. Prior to joining
Lavipharm, he was a supervisor at Richard A. Eisner & Company, LLP where he
performed audits and provided tax advice for clients in various industries
including biotech. Mr. Westgate is a Certified Public Accountant and a member
of
the New York State Society of Certified Public Accountants. He holds a B.B.A.
in
public accounting from Pace University.
WHERE
YOU CAN FIND MORE INFORMATION
We
file
annual, quarterly and special reports, proxy statements and other information
with the Securities and Exchange Commission, and we have an Internet website
address at http://www.nexmed.com.
We make
available free of charge on our internet website address our annual report
on
Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, and
amendments to those reports filed or furnished pursuant to Sections 13(a) or
15(d) of the Exchange Act as soon as reasonably practicable after we
electronically file such material with, or furnish it to, the SEC. You may
also
read and copy any document we file at the Securities and Exchange Commission's
public reference room located at 100 F Street, N.E., Washington, D.C. 20549.
Please call the Securities and Exchange Commission at 1-800-732-0330 for further
information on the operation of such public reference room. You also can request
copies of such documents, upon payment of a duplicating fee, by writing to
the
Securities and Exchange Commission at 450 Fifth Street, N.W., Washington, D.C.
20549 or obtain copies of such documents from the Securities and Exchange
Commission's website at http://www.sec.gov.
ITEM
1A. RISK
FACTORS.
FACTORS
THAT COULD AFFECT OUR FUTURE RESULTS
RISKS
RELATED TO THE COMPANY
We
continue to incur operating losses.
Our
current business operations began in 1994 and we have a limited operating
history. We may encounter delays, uncertainties and complications typically
encountered by development stage businesses. We have generated minimal revenues
from the limited sales of Befar®
in Asia
and research and development agreements and have received an initial $4 million
payment from Novartis, but have not marketed or generated revenues in the U.S.
from our products under development. We are not profitable and have incurred
an
accumulated deficit of $125,730,874 since our inception and through December
31,
2006. Our ability to generate revenues and to achieve profitability and positive
cash flow will depend on the successful licensing or commercialization of our
products currently under development. However, even if we eventually generate
revenues from sales of our products currently under development or from
licensing fees, we expect to incur significant operating losses over the next
several years. Our ability to become profitable will depend, among other things,
on our (1) development of our proposed products, (2) obtaining of regulatory
approvals of our proposed products on a timely basis and (3) success in
licensing, manufacturing, distributing and marketing our proposed products.
7
Our
independent registered public accounting firm has doubt as to our ability to
continue as a going concern.
As
a
result of our losses to date, expected losses in the future, limited capital
resources and accumulated deficit, our independent registered public accounting
firm has concluded that there is substantial doubt as to our ability to continue
as a going concern, and accordingly, our independent registered public
accounting firm has modified their report on our December 31, 2006 consolidated
financial statements included in our annual report on Form 10-K in the form
of
an explanatory paragraph describing the events that have given rise to this
uncertainty. These factors may make it more difficult for us to obtain
additional funding to meet our obligations. Our continuation is dependent upon
our ability to generate or obtain sufficient cash to meet our obligations on
a
timely basis and ultimately to attain profitable operations. We anticipate
that
we will continue to incur significant losses at least until successful
commercialization of one or more of our products, and we may never operate
profitably in the future.
We
will need partnering agreements and significant funding to continue with our
research and development efforts, and they may not be
available.
Our
research and development expenses for the years ended December 31, 2006, 2005
and 2004 were $5,425,137, $11,222,099 and $10,684,477, respectively. Since
January 1, 1994, when we repositioned ourselves as a medical and pharmaceutical
technology company, through December 31, 2006 we have spent $86,466,401 on
research and development. Given
our
current level of cash reserves and low rate of revenue generation, we will
not
be able to fully advance our products under development unless we enter into
additional partnering agreements. If we are successful in entering into
additional partnering agreements for our products under development, we may
receive milestone payments, which will offset some of our research and
development expenses.
We
will
also need significant funding to pursue our overall product development plans.
In general, products we plan to develop will require significant time-consuming
and costly research and development, clinical testing, regulatory approval
and
significant investment prior to their commercialization. Even with funding,
research and development activities may not be successful; our products may
not
prove to be safe and effective; clinical development work may not be completed;
and the anticipated products may not be commercially viable or successfully
marketed.
We
currently have no sales force or marketing organization and will need, but
may
not be able, to attract marketing partners or afford qualified or experienced
marketing and sales personnel.
In
order
to market our proprietary products under development, we will need to attract
additional marketing partner(s) that will need to spend significant funds to
inform potential customers, including third-party distributors, of the
distinctive characteristics and benefits of our products. Our operating results
and long term success will depend, among other things, on our ability to
establish (1) successful arrangements with domestic and additional international
distributors and marketing partners and (2) an effective internal marketing
organization. Consummation of partnering arrangements is subject to the
negotiation of complex contractual relationships, and we may not be able to
negotiate such agreements on a timely basis, if at all, or on terms acceptable
to us.
Pre-clinical
and clinical trials are inherently unpredictable. If we or our partners do
not
successfully conduct these trials, we or our partners may be unable to market
our products.
Through
pre-clinical studies and clinical trials, our products must be demonstrated
to
be safe and effective for their indicated uses. Results from pre-clinical
studies and early clinical trials may not allow for prediction of results in
later-stage testing. Future clinical trials may not demonstrate the safety
and
effectiveness of our products or may not result in regulatory approval to market
our products. Commercial sales in the United States of our products cannot
begin
until final FDA approval is received. The failure of the FDA to approve our
products for commercial sales will have a material adverse effect on our
prospects.
8
We
depend on Novartis to realize the potential of NM100060, and, if we successfully
enter into similar licensing agreements for other products, we will similarly
be
dependent upon our other partners.
In
September 2005, we announced a global licensing agreement with Novartis,
pursuant to which Novartis acquired the exclusive worldwide rights to NM100060,
our topical anti-fungal nail treatment product, and agreed to pay us up to
$51
million on the achievement of specific development and regulatory milestones
and
assume all costs and responsibilities related to NM100060. In addition, Novartis
agreed to pay us royalties based upon the level of sales achieved. To date,
we
have received $4 million from Novartis. In order to realize the full potential
of NM100060, we will depend upon Novartis for the development, manufacturing
and
commercialization of NM100060 and for obtaining regulatory approval of NM100060.
In addition, many of the milestones upon which the Company would receive payment
are based upon the satisfaction of criteria set by Novartis and the
determination by Novartis to seek regulatory approval for the drug. Novartis
may
terminate the licensing agreement, in its entirety or on a country-by-country
basis, by providing the Company up to 180 days notice. However, in such case
Novartis would be obligated to complete the first Phase III clinical trial
for
the product and the rights to NM100060 would revert back to NexMed. Since we
intend to pursue similar licensing arrangements for other products, we will
similarly be dependent on our partners to realize the full potential of such
products.
Patents
and intellectual property rights are important to us but could be
challenged.
Proprietary
protection for our pharmaceutical products is of material importance to our
business in the U.S. and most other countries. We have sought and will continue
to seek proprietary protection for our products to attempt to prevent others
from commercializing equivalent products in substantially less time and at
substantially lower expense. Our success may depend on our ability to (1) obtain
effective patent protection within the U.S. and internationally for our
proprietary technologies and products, (2) defend patents we own, (3) preserve
our trade secrets, and (4) operate without infringing upon the proprietary
rights of others. In addition, we have agreed to indemnify our partners for
certain liabilities with respect to the defense, protection and/or validity
of
our patents and would also be required to incur costs or forego revenue if
it is
necessary for our partners to acquire third party patent licenses in order
for
them to exercise the licenses acquired from us.
We
have
twelve U.S. patents either acquired or received out of a series of patent
applications that we have filed in connection with our NexACT®
technology and our NexACT-based products under development. To further
strengthen our global patent position on our proprietary products under
development, and to expand the patent protection to other markets, we have
filed
under the Patent Cooperation Treaty, corresponding international applications
for our issued U.S. patents and pending U.S. patent applications.
While
we
have obtained patents and have several patent applications pending, the extent
of effective patent protection in the U.S. and other countries is highly
uncertain and involves complex legal and factual questions. No consistent policy
addresses the breadth of claims allowed in or the degree of protection afforded
under patents of medical and pharmaceutical companies. Patents we currently
own
or may obtain might not be sufficiently broad to protect us against competitors
with similar technology. Any of our patents could be invalidated or
circumvented.
While
we
believe that our patents would prevail in any potential litigation, the holders
of competing patents could determine to commence a lawsuit against us and even
prevail in any such lawsuit. Litigation could result in substantial cost to
and
diversion of effort by us, which may harm our business. In addition, our efforts
to protect or defend our proprietary rights may not be successful or, even
if
successful, may result in substantial cost to us.
We
and our licensees depend upon third party manufacturers for chemical
manufacturing supplies.
We
and
our licensees are dependent on third party chemical manufacturers for the active
drugs in our NexACT®-based
products under development, and for the supply of our NexACT®
enhancers that are essential in the formulation and production of our topical
products on a timely basis and at satisfactory quality levels. If our validated
third party chemical manufacturers fail to produce quality products on time
and
in sufficient quantities, our results would suffer, as we or our licensees
would
encounter costs and delays in revalidating new third party
suppliers.
9
We
face severe competition.
We
are
engaged in a highly competitive industry. We and our licensees can expect
competition from numerous companies, including large international enterprises,
and others entering the industry with regard to our products. Most of these
companies have greater research and development, manufacturing, marketing,
financial, technological, personnel and managerial resources. Acquisitions
of
competing companies by large pharmaceutical or healthcare companies could
further enhance such competitors' financial, marketing and other resources.
Competitors may complete clinical trials, obtain regulatory approvals and
commence commercial sales of their products before we could enjoy a significant
competitive advantage. Products developed by our competitors may be more
effective than our products.
We
may be subject to potential product liability and other claims, creating risks
and expense.
We
are
also exposed to potential product liability risks inherent in the development,
testing, manufacturing, marketing and sale of human therapeutic products.
Product liability insurance for the pharmaceutical industry is extremely
expensive, difficult to obtain and may not be available on acceptable terms,
if
at all. We currently have liability insurance to cover claims related to our
products that may arise from clinical trials, with coverage of $1 million for
any one claim and coverage of $3 million in total, but we do not maintain
product liability insurance and we may need to acquire such insurance coverage
prior to the commercial introduction of our products. If we obtain such
coverage, we have no guarantee that the coverage limits of such insurance
policies will be adequate. A successful claim against us if we are uninsured,
or
which is in excess of our insurance coverage, if any, could have a material
adverse effect upon us and on our financial condition.
INDUSTRY
RISKS
We
are vulnerable to volatile market conditions.
The
market prices for securities of biopharmaceutical and biotechnology companies,
including ours, have been highly volatile. The market has from time to time
experienced significant price and volume fluctuations that are unrelated to
the
operating performance of particular companies. In addition, future
announcements, such as the results of testing and clinical trials, the status
of
our relationships with third-party collaborators, technological innovations
or
new therapeutic products, governmental regulation, developments in patent or
other proprietary rights, litigation or public concern as to the safety of
products developed by us or others and general market conditions, concerning
us,
our competitors or other biopharmaceutical companies, may have a significant
effect on the market price of our Common Stock.
We
and our licensees are subject to numerous and complex government regulations
which could result in delay and expense.
Governmental
authorities in the U.S. and other countries heavily regulate the testing,
manufacture, labeling, distribution, advertising and marketing of our proposed
products. None of our proprietary products under development has been approved
for marketing in the U.S. Before any products we develop are marketed, FDA
and
comparable foreign agency approval must be obtained through an extensive
clinical study and approval process.
The
studies involved in the approval process are conducted in three phases. In
Phase
1 studies, researchers assess safety or the most common acute adverse effects
of
a drug and examine the size of doses that patients can take safely without
a
high incidence of side effects. Generally, 20 to 100 healthy volunteers or
patients are studied in the Phase 1 study for a period of several months. In
Phase 2 studies, researchers determine the drug's efficacy with short-term
safety by administering the drug to subjects who have the condition the drug
is
intended to treat, assess whether the drug favorably affects the condition,
and
begin to identify the correct dosage level. Up to several hundred subjects
may
be studied in the Phase 2 study for approximately 6 to 12 months, depending
on
the type of product tested. In Phase 3 studies, researchers further assess
efficacy and safety of the drug. Several hundred to thousands of patients may
be
studied during the Phase 3 studies for a period of from 12 months to several
years. Upon completion of Phase 3 studies, a New Drug Application is submitted
to the FDA or foreign governmental regulatory authority for review and
approval.
10
The
failure to obtain requisite governmental approvals for our products under
development in a timely manner or at all would delay or preclude us and our
licensees from marketing our products or limit the commercial use of our
products, which could adversely affect our business, financial condition and
results of operations.
Because
we intend that our products will be sold and marketed outside the U.S., we
and/or our licensees will be subject to foreign regulatory requirements
governing the conduct of clinical trials, product licensing, pricing and
reimbursements. These requirements vary widely from country to country. The
failure to meet each foreign country's requirements could delay the introduction
of our proposed products in the respective foreign country and limit our
revenues from sales of our proposed products in foreign markets.
Successful
commercialization of our products may depend on the availability of
reimbursement to the consumer from third-party healthcare payers, such as
government and private insurance plans. Even if one or more products is
successfully brought to market, reimbursement to consumers may not be available
or sufficient to allow the realization of an appropriate return on our
investment in product development or to sell our products on a competitive
basis. In addition, in certain foreign markets, pricing or profitability of
prescription pharmaceuticals is subject to governmental controls. In the U.S.,
federal and state agencies have proposed similar governmental control and the
U.S. Congress has recently considered legislative and regulatory reforms that
may affect companies engaged in the healthcare industry. Pricing constraints
on
our products in foreign markets and possibly in the U.S. could adversely affect
our business and limit our revenues.
RISKS
RELATED TO OWNING OUR COMMON STOCK
We
do not expect to pay dividends on our common stock in the foreseeable future.
Although
our shareholders may receive dividends if, as and when declared by our board
of
directors, we do not intend to declare dividends on our Common Stock in the
foreseeable future. Therefore, you should not purchase our Common Stock if
you
need immediate or future income by way of dividends from your
investment.
We
may issue additional shares of our capital stock that could dilute the value
of
your shares of common stock.
We
are
authorized to issue 130,000,000 shares of our capital stock, consisting of
120,000,000 shares of our Common Stock and 10,000,000 shares of our preferred
stock of which 1,000,000 are designated as Series A Junior Participating
Preferred Stock, 800 are designated as Series B 8% Cumulative Convertible
Preferred Stock and 600 are designated as Series C 6% Cumulative Convertible
Preferred Stock. As of March 21, 2007, 80,354,714 shares of our Common Stock
were issued and outstanding and 23,762,305 shares of our Common Stock were
issuable upon the exercise or conversion of outstanding options, warrants,
or
other convertible securities . As of March 21, 2007, there were no shares of
Series A, Series B or Series C Preferred Stock outstanding. In light of our
possible future need for additional financing, we may issue authorized and
unissued shares of Common Stock at below current market prices or additional
convertible securities that could dilute the earnings per share and book value
of your shares of our Common Stock.
In
addition to provisions providing for proportionate adjustments in the event
of
stock splits, stock dividends, reverse stock splits and similar events, certain
warrants, provide (with certain exceptions) for an adjustment of the exercise
price if we issue shares of Common Stock at prices lower than the then exercise
or conversion price or the then prevailing market price. This means that if
we
need to raise equity financing at a time when the market price for our Common
Stock is lower than the exercise or conversion price, or if we need to provide
a
new equity investor with a discount from the then prevailing market price,
then
the exercise price will be reduced and the dilution to shareholders
increased.
ITEM
1B. UNRESOLVED
STAFF COMMENTS.
None.
ITEM
2. PROPERTIES.
11
We
currently have our principal executive offices and laboratories in a 31,500
square foot facility in East Windsor, NJ, which we own. We have invested
approximately $9.4 million for the land, building and upgrade.
NexMed
International Limited subleases 1,000 square feet of office space in Hong Kong
for approximately $3,000 per month pursuant to a month-to-month
arrangement.
ITEM
3. LEGAL
PROCEEDINGS.
We
are
subject to certain legal proceedings in the ordinary course of business. We
do
not expect any such items to have a significant impact on our financial
position.
ITEM
4. SUBMISSION
OF MATTERS TO A VOTE OF SECURITY HOLDERS.
No
matters were submitted to a vote of security holders during the fourth quarter
of 2006.
PART
II.
ITEM
5. MARKET
FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES
OF EQUITY SECURITIES.
Our
Common Stock is traded on the NASDAQ Capital Market System (“NASDAQ”) under the
symbol “NEXM.”
On
March
21, 2007, the last reported sales price for our Common Stock on NASDAQ was
$1.40
per share, and we had 241 holders of record of our Common Stock.
The
following table sets forth the range of the high and low sales prices as
reported by NASDAQ for each quarter from January 1, 2005 to December 31,
2006.
Price
of Common Stock ($)
|
|||||||
High
|
Low
|
||||||
2006
|
|||||||
First
Quarter
|
1.15
|
0.65
|
|||||
Second
Quarter
|
0.90
|
0.47
|
|||||
Third
Quarter
|
0.91
|
0.60
|
|||||
Fourth
Quarter
|
0.84
|
0.48
|
|||||
2005
|
|||||||
First
Quarter
|
1.57
|
1.02
|
|||||
Second
Quarter
|
1.45
|
1.06
|
|||||
Third
Quarter
|
2.56
|
1.25
|
|||||
Fourth
Quarter
|
1.63
|
0.71
|
|||||
Dividends
We
have
never paid cash dividends on our common stock and do not have any plans to
pay
cash dividends in the foreseeable future. Our board of directors anticipates
that any earnings that might be available to pay dividends will be retained
to
finance our business.
Perfomance
comparison of total return of NexMed, Inc., the
U.S. NASDAQ Stock market and NASDAQ Pharmaceuticals stocks
12
The
following graph shows the yearly change in cumulative total stockholder return
on NexMed Common Stock compared to the cumulative total return on the Nasdaq
Stock Market (U.S.) and Nasdaq Pharmaceutical Stocks for the past 5 fiscal
years
(assuming a $100 investment on December 31, 2001 and quarterly reinvestment
of
dividends during the period).
Unregistered
sales of equity securities and use of proceeds
On
February 28, 2007, the Company issued 28,809 shares of common stock to the
holder of the $2 million notes in payment of accrued interest for the two month
period ended January 31, 2007 of $25,000. The common stock was issued pursuant
to an exemption provided by Section 4(2) of the Securities Act of
1933.
On
February 21, 2007, the Company issued 40,000 shares of common stock upon the
exercise of warrants to purchase shares of common stock at a price of $1.11
per
share. Accordingly, the Company received proceeds of $44,400 upon the exercise
of the warrants. The common stock was issued pursuant to an exemption provided
by Section 4(2) of the Securities Act of 1933.
ITEM
6. SELECTED
FINANCIAL DATA.
13
The
following selected financial information is qualified by reference to, and
should be read in conjunction with, the Company’s consolidated financial
statements and the notes thereto, and “Management’s Discussion and Analysis of
Financial Condition and Results of Operations” contained elsewhere herein.
Income
Statement Data
|
2006
|
2005
|
2004
|
2003
|
2002
|
||||||||||||
Revenue
|
||||||||||||||||
Product
sales and royalties
|
$
|
7,243
|
$
|
9,702
|
$
|
9,519
|
$
|
6,206
|
$
|
63,417
|
||||||
Licensing
and research and development fees
|
$
|
1,859,684
|
$
|
2,389,459
|
$
|
349,850
|
$
|
104,537
|
$
|
84,611
|
||||||
Total
Expenses
|
$
|
(9,910,180
|
)
|
$
|
(17,841,599
|
)
|
$
|
(17,383,017
|
)
|
$
|
(17,344,309
|
)
|
$
|
(27,789,547
|
)
|
|
Net
Loss
|
$
|
(8,043,253
|
)
|
$
|
(15,442,438
|
)
|
$
|
(17,023,648
|
)
|
$
|
(17,233,566
|
)
|
$
|
(27,641,519
|
)
|
|
Basic
and Diluted Loss per Share
|
$
|
(0.12
|
)
|
$
|
(0.32
|
)
|
$
|
(0.39
|
)
|
$
|
(0.60
|
)
|
$
|
(1.03
|
)
|
|
Weighted
Average Common Shares Outstanding Used for Basic and Diluted Loss
per
Share
|
66,145,807
|
52,528,345
|
43,603,546
|
33,649,774
|
26,937,200
|
|||||||||||
Balance
Sheet Data
|
December
31,
|
|
|
December
31,
|
|
|
December
31,
|
|
|
December
31,
|
|
|
December
31,
|
|||
2006
|
|
|
2005
|
|
|
2004
|
|
|
2003
|
|
|
2002
|
||||
Total
Assets
|
$
|
19,933,634
|
$
|
13,331,943
|
$
|
20,272,661
|
$
|
23,133,679
|
$
|
14,140,127
|
||||||
Total
Long Term Liabilities
|
$
|
1,058,098
|
$
|
4,122,997
|
$
|
6,801,826
|
$
|
7,335,877
|
$
|
5,782,518
|
||||||
Stockholders’
Equity
|
$
|
11,504,475
|
$
|
640,354
|
$
|
11,401,285
|
$
|
12,723,408
|
$
|
3,223,492
|
We
do not
have any off-balance sheet arrangements.
ITEM
7.
|
|
MANAGEMENT’S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
OPERATION.
|
General
We
are
currently focusing our efforts on new and patented topical pharmaceutical
products based on a penetration enhancement drug delivery technology known
as
NexACT®,
which
may enable an active drug to be better absorbed through the skin.
We
have
applied the NexACT®
technology to a myriad of drug compounds and delivery systems, and are in
various stages of developing new topical treatments for sexual dysfunction
and
nail fungus.
We
intend
to pursue our research, development, and execute a business strategy with the
goal of achieving a level of development sufficient to enable us to attract
potential strategic partners with resources sufficient to further develop and
market our proprietary products both domestically and internationally.
Liquidity,
Capital Resources and Financial Condition.
We
have
experienced net losses and negative cash flows from operations each year since
our inception. Through December 31, 2006, we had an accumulated deficit of
$125,730,874. 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.
In
January 2006, we completed a private placement of common stock and warrants
pursuant to which we raised over $8.3 million in gross proceeds. We sold
9,347,191 shares of our common stock at $0.89 per share. The investors received
four-year warrants to purchase 3,738,876 shares of common stock, exercisable
beginning six months after closing at a price of $1.11 per share. The proceeds
from this financing are being used for general corporate purposes and for our
product development programs based on the NexACT®
technology.
14
In
December 2006, we completed a private placement of common stock and warrants
pursuant to which we raised over $8.65 million in gross proceeds. We sold
13,317,000 shares of our common stock at $0.6501 per share. The investors
received four-year warrants to purchase 5,326,800 shares of common stock,
exercisable beginning six months after closing at a price of $0.79 per share.
The proceeds from this financing are being used for general corporate purposes
and for our product development programs based on the NexACT®
technology.
We
project that our cash reserves of $10.9 million as of the date of this report
are sufficient to sustain our operations through approximately the end of
2007
if we are unable to renegotiate our $5 million of notes due in 2007 to be
able
to postpone repayment or repay amounts in equity rather than cash. However
we
are confident that we can renegotiate the notes, sell our facility in East
Windsor, NJ or rely on expected milestone payments from our Novartis licensing
agreement to fund the repayment of the notes. If we are able to achieve any
one
of the aforementioned objectives then we project that our cash reserves of
$10.9
million as of the date of this report are sufficient to sustain our operations
for approximately 19 months at the current burn rate of approximately $450,000
per month. There is no assurance that we will be able to renegotiate our
notes
on terms acceptable to us, if at all. Further, there is no assurance that
milestone payments from our Novartis licensing agreement will be earned or
that
we will be able to sell our facility in East Windsor, NJ.
As
a
result of our losses to date, expected losses in the future, limited capital
resources and accumulated deficit, our independent registered public accounting
firm has concluded that there is substantial doubt as to our ability to continue
as a going concern for a reasonable period of time, and have modified their
report 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 continuation is based
on our ability to generate or obtain sufficient cash to meet our obligations
on
a timely basis and ultimately to attain profitable operations. We anticipate
that we will continue to incur significant losses at least until successful
commercialization of one or more of our products. There can be no assurance
that
we can operate profitably in the future.
At
December 31, 2006 we had cash and cash equivalents and short term investments
of
approximately $12.1 million as compared to $3.5 million at December 31, 2005.
Our net increase in cash in 2006 is the result of the net proceeds of $16.3
million received from equity private placements in January and December 2006
and
the aforementioned $627,455 termination fee received from Schering AG, offset
by
expenditures of approximately $7.2 million, which consisted of approximately
$1.5 million of severance payments related to our restructuring program
implemented in December 2005 as well as our average fixed monthly overhead
costs
in 2006 of approximately $475,000 per month. Additonally we repaid our $3
million note due on November 30, 2006 and issued a new $2 million note due
December 31, 2007 for which we received $1,975,000 in net proceeds.
At
December 31, 2006 we had a $183,700 other receivable as compared to $582,440
at
December 31, 2005. The other receivable consists of amounts billed to our
licensing partner in connection with the exclusive global licensing agreement
for our NM100060 nail lacquer. Pursuant to the terms of the agreement, Novartis
has agreed to reimburse us for related patent expenses as well as the remaining
costs to completion of preclinical studies that we had begun prior to the
signing of the agreement. We billed significantly more to Novartis in the fourth
quarter of 2005 than in the fourth quarter of 2006 as the preclinical studies
were initiated late in 2005. The costs to initiate the preclinical studies
are
significantly higher than the study maintenance costs incurred during the study.
At
December 31, 2006, we had $156,557 in payroll related liabilities as compared
to
$1,135,671 at December 31, 2005. The decrease is attributable to the payment
in
the first quarter of 2006 of severance costs accrued in 2005 as a result of
our
significant reduction in staff in December 2005, including approximately
$740,000 relating to severance accrued upon the departure of Dr. Mo as Chief
Executive Officer of the Company on December 15, 2005.
At
December 31, 2006 we had a $1,872,615 note payable as compared to zero at
December 31, 2005. On November 30, 2006, we issued a Note in principal amount
of
$2 million. The Note is payable on the earlier of December 31, 2007 or the
closing by the Company on the sale of the Company’s facility in East Windsor,
New Jersey. We also issued the Note holder a 4-year detachable warrant to
purchase 500,000 shares of common stock at an exercise price of $0.5535. We
valued the warrants using the Black-Scholes pricing model and allocated a
relative fair value of $138,000 to the warrants. The relative fair value of
the
warrants is allocated to additional paid in capital and treated as a discount
to
the Note that is being amortized over the 13-month period ended December 31,
2007. For the year ended December 31, 2006, the Company recorded $10,615 of
interest expense related to the amortization of the Note discount.
15
At
December 31, 2006 we had convertible notes payable of $3,000,000 as compared
to
$6,000,000 at December 31, 2005. On November 30, 2006, we used the proceeds
from
the above $2 million note along with $1 million from our cash on hand to pay
in
cash the $3 million installment due on November 30, 2006 pursuant to the terms
of the convertible note. The remaining $3 million balance plus accrued interest
on the Note is payable on May 31, 2007.
For
the
year ended December 31, 2006 we incurred a loss on disposal of fixed assets
in
the amount of $652,081 as compared to $16,371 in 2005. The increase in loss
on
disposal of fixed assets resulted from the consolidation of our operations
into
our East Windsor facility which was originally designed for manufacturing with
offices and laboratories. In consolidating our facilities and reducing staff
we
determined that we had excess laboratory equipment. We wrote off obsolete
equipment and sold many pieces of equipment to improve cash flow receiving
approximately $180,000 in net proceeds. Additionally, the consolidation in
facilities will result in savings to us of approximately $600,000 per year.
Since
2000, we have spent approximately $9.4 million in total for the land, building,
manufacturing and lab equipment, related to our East Windsor facility which
we
are currently occupying.
The
following table summarizes our contractual obligations and the periods in which
payments are due as of December 31, 2006:
Less
than
|
1
- 3
|
3
- 5
|
More
than
|
|||||||||||||
Contractual
Obligations
|
Total
|
1
year
|
years
|
years
|
5
years
|
|||||||||||
Long-term
debt *
|
$
|
5,224,167
|
$
|
5,224,167
|
$
|
0
|
$
|
0
|
$
|
0
|
||||||
Capital
lease obligations
|
0
|
0
|
0
|
0
|
||||||||||||
Operating
leases
|
0
|
0
|
0
|
0
|
0
|
|||||||||||
Purchase
obligations **
|
5,437,575
|
3,997,985
|
1,439,590
|
0
|
0
|
|||||||||||
Other
long-term liabilities***
|
1,529,393
|
109,900
|
329,700
|
329,700
|
760,093
|
|||||||||||
Total
|
$
|
12,191,135
|
$
|
9,332,052
|
$
|
1,769,290
|
$
|
329,700
|
$
|
760,093
|
* |
Long-term
debt consists of two notes totaling $3 million that are convertible
to
common stock at the option of the noteholders and one note in
the amount of $2 million plus all related interest. Interest
is payable in
stock or cash at the Company's
option.
|
** |
Purchase
obligations consist of clinical research agreements that can
be cancelled
at any time with thirty days notice. The penalty for our cancellation
of
one of these agreements totaling $4,182,700 is approximately
$1.1 million
if cancelled prior to 50% completion or
10% of the outstanding contract amount at the time of cancellation
if
cancelled after the study is 50%
complete.
|
*** |
Represents
the payments to be made according to a deferred compensation
agreement.
The present value of these payments is
recorded on the balance sheet under deferred compensation in
the amount of
$1,058,098
|
Off-Balance
Sheet Arrangements
We
do not
have any off-balance sheet arrangements.
Restructuring
We
have
significantly cut our monthly expenses by streamlining our operations in 2006.
We consolidated our operations into the East Windsor facility that was
originally designed for manufacturing with offices and laboratories, which
resulted in savings of approximately $600,000 per year. Further, we reduced
our
staff by approximately 50%, which, with reductions made in December 2005,
resulted in annual savings of approximately $2.8 million. We have incurred
and
expensed approximately $240,000 in 2006 in connection with the reduction in
staff related to this restructuring. These costs are included in Research and
development expenses in the Consolidated Statement of Operations and
Comprehensive Loss for the year ended December 31, 2006.
16
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. Note 2 in the Notes to the Consolidated Financial Statements, includes
a summary of the significant accounting policies and methods used in the
preparation of our Consolidated Financial Statements. The preparation of these
financial statements requires our management to make estimates and assumptions
that affect the reported amounts of assets, liabilities, revenues 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. The following is a brief description of the more significant
accounting policies and related estimate methods that we follow:
Income
Taxes - In
preparing our financial statements, we make estimates of our current tax
exposure and temporary differences resulting from timing differences for
reporting items for book and tax purposes. We recognize deferred taxes by the
asset and liability method of accounting for income taxes. Under the asset
and
liability method, deferred income taxes are recognized for differences between
the financial statement and tax bases of assets and liabilities at enacted
statutory tax rates in effect for the years in which the differences are
expected to reverse. The effect on deferred taxes of a change in tax rates
is
recognized in income in the period that includes the enactment date. In
addition, valuation allowances are established when necessary to reduce deferred
tax assets to the amounts expected to be realized.
Critical
Estimate: In
consideration of our accumulated losses and lack of historical ability to
generate taxable income to utilize our deferred tax assets, we have estimated
that we will not be able to realize any benefit from our temporary differences
and have recorded a full valuation allowance. If we become profitable in the
future at levels which cause management to conclude that it is more likely
than
not that we will realize all or a portion of the net operating loss
carry-forward, we would immediately record the estimated net realized value
of
the deferred tax asset at that time and would then provide for income taxes
at a
rate equal to our combined federal and state effective rates, which would be
approximately 40% under current tax laws. Subsequent revisions to the estimated
net realizable value of the deferred tax asset could cause our provision for
income taxes to vary significantly from period to period.
Long-lived
assets -- We
review
for the impairment of long-lived assets whenever events or circumstances
indicate that the carrying amount of an asset may not be recoverable. An
impairment loss would be recognized when estimated undiscounted future cash
flows expected to result from the use of the asset and its eventual disposition
are less than its carrying amount. If such assets are considered impaired,
the
amount of the impairment loss recognized is measured as the amount by which
the
carrying value of the asset exceeds the fair value of the asset, fair value
being determined based upon discounted cash flows or appraised values, depending
on the nature of the asset. We have not identified any such impairment
losses.
Critical
Estimate:
Estimated
undiscounted future cash flows are based on revenue projections for our products
under development for which the long-lived assets are used. In 2005 and 2004,
we
performed a review for impairment of our manufacturing facility based on
projections of sales of our product candidates. Overestimating the future cash
flows resulting from the commercialization of Alprox TDâ
may lead
to overstating the carrying value of the manufacturing facility by not
identifying an impairment loss.
Revenue
recognition -- Revenues
from product sales are recognized upon delivery of products to customers, less
allowances for returns and discounts. Royalty revenue is recognized upon the
sale of the related products as reported to us by our distribution partner,
provided the royalty amounts are fixed or determinable and the amounts are
considered collectible. Revenues earned under license and research and
development contracts are recognized in accordance with the cost-to-cost method
outlined in Staff Accounting Bulletin No. 101, as amended, whereby the extent
of
progress toward completion is measured on the cost-to-cost basis; however,
revenue recognized at any point will not exceed the cash received. If the
current estimates of total contract revenue and contract cost indicate a loss,
a
provision for the entire loss on the contract would be made. All costs related
to these agreements are expensed as incurred and classified within “Research and
development” expenses in the Consolidated Statements of Operations and
Comprehensive Loss. Research and development expenses include costs directly
attributable to the conduct of our research and development, including salaries,
payroll taxes, employee benefits, materials, supplies, depreciation on and
maintenance of research equipment, costs related to research and development
fee
agreements, the cost of services provided by outside contractors, including
services related to our clinical trials, clinical trial expenses, the full
cost
of manufacturing drugs for use in research, pre-clinical and clinical
development, and the allocable portion of facility costs.
17
Also,
licensing agreements typically include several elements of revenue, such as
up-front payments, milestones, royalties upon sales of product, and the delivery
of product and/or research services to the licensor. We follow the accounting
guidance of SEC Staff Accounting Bulletin No. 104 (which superseded SEC
Staff Accounting Bulletin No. 101) (“SAB 104”), an analogy to EITF
No. 91-6 and EITF No. 00-21 (which became effective for contracts entered
into after June 2003). Non-refundable license fees received upon execution
of
license agreements where we have continuing involvement are deferred and
recognized as revenue over the estimated performance period of the agreement.
This requires management to estimate the expected term of the agreement or,
if
applicable, the estimated life of its licensed patents.
In
addition, EITF No. 00-21 requires a company to evaluate its arrangements under
which it will perform multiple revenue-generating activities. For example,
a
license agreement with a pharmaceutical company may involve a license, research
and development activities and/or contract manufacturing. Management is required
to determine if the separate components of the agreement have value on a
standalone basis and qualify as separate units of accounting, whereby
consideration is allocated based upon their relative “fair values” or, if not,
the consideration should be allocated based upon the “residual method.”
Accordingly, up-front and development stage milestone payments will be deferred
and recognized as revenue over the performance period of such license
agreement.
Critical
Estimate:
In
calculating the progress made toward completion of a research contract or
licensing agreement, we must compare costs incurred to date to the total
estimated cost of the project and/or estimate the performance period. We
estimate the cost and/or performance period of any given project based on our
past experience in product development as well as the past experience of our
research staff in their areas of expertise. Underestimating the total cost
and/or performance period of a research contract or licensing agreement may
cause us to accelerate the revenue recognized under such contract. Conversely,
overestimating the cost may cause us to delay revenue recognized.
Stock
based compensation
- In
preparing our financial statements, we must calculate the value of stock options
issued to employees, non-employee contractors and warrants issued to investors.
The fair value of each option and warrant is estimated on the date of grant
using the Black-Scholes option-pricing model. The Black-Scholes option-pricing
model is a generally accepted method of estimating the value of stock options
and warrants.
Critical
Estimate:
The
Black-Scholes option pricing model requires us to estimate the Company’s
dividend yield rate, expected volatility and risk free interest rate over the
life of the option. Inaccurately estimating any one of these factors may cause
the value of the option to be under or over estimated. See Note 2 of the
Consolidated Financial Statements for the current estimates used in the Black
-Scholes pricing model. We adopted the provisions of SFAS 123R commencing
January 1, 2006.
Comparison
of Results of Operations between the Years Ended December 31, 2006 and 2005
Revenues.
We
recorded revenues of $1,866,927 during 2006 as compared to $2,399,161 in 2005.
The revenue consisted of $7,243 and $9,702 , respectively, of royalties on
sales
of Befar®
in Hong
Kong and China received from our Asian licensee and $1,859,684 and $2,389,459,
respectively, of revenue recognized on our Novartis licensing agreement.
Research
and Development Expenses.
Our
research and development expenses decreased from $11,222,099 in 2005 to
$5,425,137 in 2006. Research and development expenses in 2006 included
approximately $997,000 attributable to Alprox-TD®
and
$940,000 attributable to NM100060, $233,000
attributable to severance pay related to our restructuring program initially
implemented in December 2005 and the balance of approximately $3.1 million
attributable to other NexACT®
technology based products and indirect overhead related to research and
development including costs to consolidate our three research and development
labs into our one location in East Windsor,
as
compared to approximately $2.2 million attributable to Alprox-TD®,
and
$3.2 million attributable to NM100060 with the balance attributable to other
NexACT®
technology based products and indirect overhead related to research and
development in 2005. Research and development expenses related to NM100060
was a
net zero in 2006 as Novartis has taken over all development costs and reimburses
us for our remaining preclinical studies. Such reimbursement is shown as
licensing fee revenue in the consolidated statements of operations.
Additionally, total research and development expenses for the full year 2006
were lower as compared to 2005 expenses as we have significantly reduced the
research and development staff and consolidated our facilities in 2006.
18
General
and Administrative Expenses.
Our
general and administrative expenses have decreased from $6,878,335 in 2005
to
$5,570,765 in 2006. The decrease is primarily due to a decrease in overhead,
including rent, insurance and utilities, of approximately $506,000 as a result
of the completion of our consolidation of facilities in April 2006. We had
a
decrease in general and administrative salaries of approximately $1,665,000
as a
result of 2005 accrued severance and deferred compensation in connection with
our restructuring program initially implemented in December 2005 which reduced
our total staff for 2006. There was also a decrease in legal expenses of
approximately $390,000 due to the fact that we had no active lawsuits pending
in
2006 whereas we had one outstanding lawsuit in 2005. We also had a decrease
in
legal fees related to patents of approximately $410,000 as a result of our
decision to reduce the number of national patent filings we would pursue on
early stage pipeline products. These decreases were partially offset by an
increase in compensation expense of $1,127,603 as a result of adopting SFAS
123R
on January 1, 2006 which requires the recognition of compensation expense for
all stock-based awards made to employees and directors. Additionally, in 2006
we
recognized a loss on the disposal of equipment of approximately $650,000 as
a
result the consolidation of our operations into our East Windsor facility.
Interest
Expense.
We
recognized $380,860 in interest expense in 2006 as compared to $344,352 in
interest expense in 2005. The increase is primarily due to imputed interest
expense related to approximately $110,000 in deferred compensation payments
made
to Dr. Joseph Mo, former CEO, pursuant to the deferred compensation agreement
as
discussed in Note 5 of the Consolidated Financial Statements.
Other
income. Other
income was $627,455 in 2006 as compared to zero during the same period in 2005.
The 2006 other income consisted of a one-time payment received when Schering
elected to terminate the supply and distribution agreement for
Alprox-TD®
without
cause. Pursuant to the agreement, Schering was obligated to pay us a termination
fee of 500,000 Euros or $627,455.
Net
Loss.
The net
loss was $8,043,253 and $15,442,438 in 2006 and 2005, respectively. The decrease
is primarily attributable to our restructuring program initially implemented
in
December 2005 whereby we significantly reduced our research and development
project expenditures and staff and reduced our overhead by consolidating our
facilities in 2006.
Net
Loss applicable to Common Stock. The
net
loss applicable to common stock was $8,108,414 or $0.12 per share for 2006
as
compared to $16,550,479 or $0.32 per share for 2005. The decrease in net loss
applicable to common stock is primarily attributable to our
restructuring program initially implemented in December 2005 whereby we
significantly reduced our research and development project expenditures and
staff and reduced our overhead by consolidating our facilities in
2006. The
decrease also resulted from the large deemed dividend to preferred shareholders
in the second and third quarters of 2005 as discussed in Note 11 of the
Consolidated Financial Statements.
Comparison
of Results of Operations between the Years Ended December 31, 2005 and 2004
Revenues.
We
recorded revenues of $2,399,161 during 2005 as compared to $359,369 in 2004.
The
revenue consisted of $9,702 and $9,519, respectively, in royalties on sales
of
Befar®
in Hong
Kong and China received from our Asian licensee and $2,389,459 and $349,850,
respectively, of revenue recognized on our Novartis licensing agreement signed
in 2005 and research and development agreements with Japanese pharmaceutical
companies in 2004.
19
Research
and Development Expenses.
Our
research and development expenses for 2005 and 2004 were $11,222,099 and
$10,684,477 respectively. Research and development expenses included $2,205,019
attributable to Alprox-TD®
in
2005,
and $3,166,248 attributable to NM100060 with the balance attributable to other
NexACT®
technology based products and indirect overhead related to research and
development, as compared to $2,279,848 for Alprox-TD®
and
$393,858 for NM100060 during the same period in 2004.
General
and Administrative Expenses.
Our
general and administrative expenses were $6,878,335 in 2005 as compared to
$6,979,730 in 2004. The decrease is primarily due to decreased legal expenses
in
2005 related to the defense of three lawsuits in 2004 as compared to one in
2005; decreased professional fees in 2005 as compared to 2004, when such fees
were considerably higher as a result of initial compliance activities mandated
by the Sarbanes Oxley Act of 2002; partially offset by severance payments
accrued at year end in connection with our significant reduction in staff in
December 2005 including approximately $1,350,000 accrued and expensed relating
to severance and deferred compensation upon the departure of Dr. Mo as President
and Chief Executive Officer of the Company on December 15, 2005.
Other
income (expense). Other
income was zero during 2005 as compared to other income of $82,271 during 2004.
The other income for 2004 consisted of a one-time payment that was received
by
the Company upon cancellation of one of our research and development agreements
with a Japanese pharmaceutical company.
Interest
Expense.
We
recognized $344,352 in interest expense in 2005 as compared to $425,128 in
interest expense in 2004. The decrease is due to a decrease in interest expense
on our capital leases with GE Capital as the principal amounts owed decrease
over time with our monthly payments over the life of the leases. In 2005, our
February 2001 capital lease was paid in full and we therefore no longer incured
interest on such lease.
Net
Loss.
The net
loss was $15,442,438 and $17,023,648 in 2005 and 2004, respectively. The
decrease is primarily attributable to the revenue recognized in connection
with
our worldwide licensing agreement with Novartis for our NM100060 nail lacquer.
In 2005, we received $4.8 million in milestone payments and expense
reimbursements and recognized $2,389,459 in revenue in accordance with the
cost-to-cost method as discussed in Note 3 of the Consolidated Financial
Statements.
Net
Loss applicable to Common Stock. The
net
loss applicable to common stock was $16,550,479 or $0.32 per share for 2005
as
compared to $17,023,648 or $0.39 per share for 2004. The decrease in net loss
applicable to common stock is primarily attributable to the revenue recognized
in connection with the Novartis licensing agreement offset by the deemed
dividend to preferred shareholders in 2005 as discussed in note 11 of the
Consolidated Financial Statements.
Quarterly
Results
The
following table sets forth selected unaudited quarterly financial information
for the years ended December 31, 2006 and 2005. The operating results are not
necessarily indicative of results for any future period.
For
the Three Months
Ended
|
|||||||||||||
|
March
31,
2006
|
|
June
30,
2006
|
|
September
30,
2006
|
|
December
31,
2006
|
||||||
Total
Revenues
|
$
|
453,947
|
$
|
533,655
|
$
|
446,268
|
$
|
433,057
|
|||||
Loss
from Operations
|
($2,886,199
|
)
|
($1,628,263
|
)
|
($1,965,890
|
)
|
($2,648,623
|
)
|
|||||
Net
Loss
|
($2,906,293
|
)
|
($1,022,851
|
)
|
($1,987,835
|
)
|
($2,126,274
|
)
|
|||||
Basic
& Diluted Loss Per
Share
|
$
|
(0.05
|
)
|
$
|
(0.02
|
)
|
$
|
(0.03
|
)
|
$
|
(0.03
|
)
|
|
|
|
March
31,
2005
|
|
June
30,
2005
|
|
September
30,
2005
|
|
December
31,
2005
|
||||||
Total
Revenues
|
$
|
2,381
|
$
|
2,329
|
$
|
2,502
|
$
|
2,391,949
|
|||||
Loss
from Operations
|
($4,564,913
|
)
|
($4,325,914
|
)
|
($3,134,817
|
)
|
($3,675,629
|
)
|
|||||
Net
Loss
|
($4,624,270
|
)
|
($4,378,846
|
)
|
($3,192,347
|
)
|
($3,246,975
|
)
|
|||||
Basic
& Diluted Loss Per
Share
|
$
|
(0.09
|
)
|
$
|
(0.10
|
)
|
$
|
(0.07
|
)
|
$
|
(0.06
|
)
|
20
ITEM
7A. QUANTITATIVE
AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.
We
do not
hold derivative financial investments, derivative commodity investments, engage
in foreign currency hedging or other transactions that expose us to material
market risk. The interest rates on our existing debt are fixed.
ITEM
8. FINANCIAL
STATEMENTS AND SUPPLEMENTARY DATA.
INDEX
TO
FINANCIAL STATEMENTS
PAGE
|
||||
Report
of Independent Registered Public Accounting Firm 2006
|
22
|
|||
Report
of Independent Registered Public Accounting Firm 2005
|
23
|
|||
Financial
Statements
|
24
|
|||
Consolidated
Balance Sheets - December 31, 2006 and 2005
|
24
|
|||
Consolidated
Statements of Operations and Comprehensive Loss for the years ended
December 31, 2006, 2005 and 2004
|
25
|
|||
Consolidated
Statements of Changes in Stockholders' Equity for years ended December
31,
2006, 2005 and 2004 and
|
26
|
|||
Consolidated
Statements of Cash Flows for the years ended December 31, 2006, 2005
and
2004
|
27
|
|||
Notes
to the Consolidated Financial Statements
|
28
|
|||
Schedule
II - Valuation of Qualifying Accounts
|
51
|
21
Report
of Independent Registered Public Accounting Firm
The
Board
of Directors and Stockholders
NexMed,
Inc.
We
have
audited the accompanying consolidated balance sheet of NexMed, Inc. and
Subsidiaries as of December 31, 2006, and the related consolidated statements
of
operations, comprehensive income (loss), stockholders' equity (deficit),
and
cash flows for the year ended December 31, 2006. These consolidated financial
statements are the responsibility of the Company's management. Our
responsibility is to express an opinion on these consolidated financial
statements based on our audit.
We
conducted our audit in accordance with the standards of the Public Company
Accounting Oversight Board (United States). Those standards require that
we plan
and perform the audit to obtain reasonable assurance about whether the
financial
statements are free of material misstatement. An audit includes examining,
on a
test basis, evidence supporting the amounts and disclosures in the financial
statements. An audit also includes assessing the accounting principles
used and
significant estimates made by management, as well as evaluating the overall
financial statement presentation. We believe that our audit provides a
reasonable basis for our opinion.
In
our
opinion, the consolidated financial statements referred to above present
fairly,
in all material respects, the financial position of NexMed, Inc. and
subsidiaries as of December 31, 2006, and the results of their operations
and
their cash flows for the year ended December 31, 2006, in conformity with
U.S.
generally accepted accounting principles.
The
accompanying financial statements have been prepared assuming that the
Company
will continue as a going concern. As discussed in Note 1 to the financial
statements, the Company has suffered recurring losses and negative cash
flows
from operations and expects to incur future losses that raise substantial
doubt
about its ability to continue as a going concern. Management’s plans in regard
to these matters are also described in Note 1. The accompanying consolidated
financial statements do not include any adjustments that might result from
the
outcome of this uncertainty.
As
discussed in Note 2, the Company changed its method of accounting for
“stock-based compensation” in 2006.
/s/
Amper, Politziner & Mattia, PC
March
21,
2007
Edison,
New Jersey
22
Report
of Independent Registered Public Accounting Firm
To
the
Board of Directors and Stockholders of NexMed, Inc.:
In
our
opinion, the consolidated balance sheet as of December 31, 2005 and the related
consolidated statement of operations and comprehensive loss, stockholders'
equity, and cash flows
for
each of two years in the period ended December 31, 2005 present fairly, in
all
material respects,
the financial position of NexMed, Inc. and its subsidiaries at December 31,
2005, and the results of their operations and their cash flows for each of
the
two years in the period ended December 31, 2005, in conformity with accounting
principles generally accepted in the United States
of
America. In addition, in our opinion, the financial statement schedule for
each
of the two
years
in the period ended December 31, 2005 presents fairly, in all material respects,
the information set forth therein when read in conjunction with the related
consolidated financial statements. These financial statements and financial
statement schedule are the responsibility of the
Company's management. Our responsibility is to express an opinion on these
financial statements and financial statement schedule based on our audits.
We
conducted our audits of these
statements in accordance with the standards of the Public Company Accounting
Oversight Board
(United States). Those standards require that we plan and perform the audit
to
obtain reasonable
assurance about whether the financial statements are free of material
misstatement. An
audit
includes examining, on a test basis, evidence supporting the amounts and
disclosures in the financial statements, assessing the accounting principles
used and significant estimates made by
management, and evaluating the overall financial statement presentation.
We
believe that our audits provide a reasonable basis for our opinion.
PricewaterhouseCoopers
LLP
New
York,
New York
March
15,
2006
23
NexMed,
Inc.
Consolidated Balance
Sheets
December
31,
|
|||||||
|
2006
|
2005
|
|||||
Assets
|
|||||||
Current
assets
|
|||||||
Cash
and cash equivalents
|
$
|
11,069,133
|
$
|
2,953,781
|
|||
Short
term investments
|
1,000,000
|
500,000
|
|||||
Other
receivable
|
183,700
|
582,440
|
|||||
Debt
issuance cost, net of accumulated amortization of $11,742
|
27,803
|
8,035
|
|||||
Prepaid
expenses and other current assets
|
164,898
|
373,935
|
|||||
Total
current assets
|
12,445,534
|
4,418,191
|
|||||
Fixed
assets, net
|
7,488,100
|
8,905,716
|
|||||
Debt
issuance cost, net of accumulated amortization of $0 and
$11,742
|
-
|
8,036
|
|||||
Total
assets
|
$
|
19,933,634
|
$
|
13,331,943
|
|||
Liabilities
and Stockholders' Equity
|
|||||||
Current
liabilities
|
|||||||
Accounts
payable and accrued expenses
|
$
|
587,750
|
$
|
690,263
|
|||
Payroll
related liabilities
|
156,567
|
1,135,671
|
|||||
Deferred
revenue
|
1,693,917
|
2,785,801
|
|||||
Deferred
compensation - current portion
|
60,212
|
55,200
|
|||||
Note
payable, net of debt discount of $127,385
|
1,872,615
|
-
|
|||||
Convertible
notes payable - current portion
|
3,000,000
|
3,000,000
|
|||||
Capital
lease obligation - current portion
|
-
|
233,827
|
|||||
Total
current liabilities
|
7,371,061
|
7,900,762
|
|||||
Long
term liabilities
|
|||||||
Convertible
notes payable
|
-
|
3,000,000
|
|||||
Deferred
compensation
|
1,058,098
|
1,122,997
|
|||||
Total
liabilities
|
8,429,159
|
12,023,759
|
|||||
Series
C 6% cumulative convertible preferred stock
|
-
|
667,830
|
|||||
Commitments
and contingincies (Note 16)
|
|||||||
Stockholders'
equity:
|
|||||||
Common
stock, $.001 par value, 120,000,000 shares authorized,
|
|||||||
80,285,905
and 55,699,467 shares issued and outstanding, respectively
|
80,287
|
55,700
|
|||||
Additional
paid-in capital
|
137,164,658
|
118,281,871
|
|||||
Accumulated
other comprehensive loss
|
(9,596
|
)
|
(9,596
|
)
|
|||
Accumulated
deficit
|
(125,730,874
|
)
|
(117,687,621
|
)
|
|||
Total
stockholders' equity
|
11,504,475
|
640,354
|
|||||
|
|||||||
Total
liabilities, convertible preferred stock
|
|||||||
and
stockholders' equity
|
$
|
19,933,634
|
$
|
13,331,943
|
The
accompanying notes are an integral part of these consolidated financial
statements.
24
NexMed,
Inc.
Consolidated
Statements of Operations and Comprehensive Loss
For
the Year Ended
|
||||||||||
December
31,
|
||||||||||
2006
|
|
2005
|
|
2004
|
||||||
Revenue
|
||||||||||
Royalties
|
$
|
7,243
|
$
|
9,702
|
$
|
9,519
|
||||
Licensing
and research and development fees
|
1,859,684
|
2,389,459
|
349,850
|
|||||||
Total
revenue
|
1,866,927
|
2,399,161
|
359,369
|
|||||||
Costs
and expenses
|
||||||||||
Research
and development
|
5,425,137
|
11,222,099
|
10,684,477
|
|||||||
General
and administrative
|
5,570,765
|
6,878,335
|
6,979,730
|
|||||||
Total
costs and expenses
|
10,995,902
|
18,100,434
|
17,664,207
|
|||||||
Loss
from operations
|
(9,128,975
|
)
|
(15,701,273
|
)
|
(17,304,838
|
)
|
||||
Other
income (expense)
|
||||||||||
Other
income
|
627,455
|
-
|
82,271
|
|||||||
Interest
income
|
271,730
|
122,071
|
85,000
|
|||||||
Interest
expense
|
(380,860
|
)
|
(344,352
|
)
|
(425,128
|
)
|
||||
Total
other income (expense)
|
518,325
|
(222,281
|
)
|
(257,857
|
)
|
|||||
Loss
before benefit from income taxes
|
(8,610,650
|
)
|
(15,923,554
|
)
|
(17,562,695
|
)
|
||||
Benefit
from income taxes
|
567,397
|
481,116
|
539,047
|
|||||||
Net
loss
|
(8,043,253
|
)
|
(15,442,438
|
)
|
(17,023,648
|
)
|
||||
Deemed
dividend to preferred shareholders
|
||||||||||
from
beneficial conversion feature
|
(49,897
|
)
|
(984,715
|
)
|
-
|
|||||
Preferred
dividend
|
(15,264
|
)
|
(123,326
|
)
|
-
|
|||||
Net
loss applicable to common stock
|
(8,108,414
|
)
|
(16,550,479
|
)
|
(17,023,648
|
)
|
||||
Other
comprehensive loss
|
||||||||||
Foreign
currency translation adjustments
|
-
|
592
|
(13,671
|
)
|
||||||
Comprehensive
loss
|
$
|
(8,043,253
|
)
|
$
|
(15,441,846
|
)
|
$
|
(17,037,319
|
)
|
|
Basic
and diluted loss per share
|
$
|
(.12
|
)
|
$
|
(.32
|
)
|
$
|
(.39
|
)
|
|
Weighted
average common shares outstanding
|
||||||||||
used
for basic and diluted loss per share
|
66,145,807
|
52,528,345
|
43,603,546
|
The
accompanying notes are an integral part of these consolidated financial
statements.
25
NexMed,
Inc.
Consolidated
Statements of Changes in Stockholders’ Equity
|
Accumulated
other comprehensive income (loss)
|
||||||||||||||||||||||||||||||
Common
Stock
(Shares)
|
|
Common
Stock
(Amount)
|
|
Preferred
Stock
(Shares)
|
|
Preferred
Stock
(Amount)
|
|
Additional
Paid-in Capital
|
|
Accumulated
Deficit
|
|
Deferred
Compensation
|
|
Foreign
Currency
transalation
|
|
Unrealized
loss
on
marketable
securities
|
|
Total
Stockholders'
Equity
|
|||||||||||||
Balance
at January 1, 2004
|
40,123,127
|
$
|
40,124
|
-
|
-
|
$
|
97,924,314
|
($85,221,535
|
)
|
$
|
(19,332
|
)
|
$
|
3,483
|
($3,646
|
)
|
$
|
12,723,408
|
|||||||||||||
Issuance
of common stock from private placement, net of commission
paid
|
11,011,978
|
11,012
|
-
|
-
|
14,194,674
|
-
|
-
|
-
|
-
|
14,205,686
|
|||||||||||||||||||||
Issuance
of common stock upon exercise of stock options and
warrants
|
200,482
|
200
|
-
|
-
|
187,472
|
-
|
-
|
-
|
-
|
187,672
|
|||||||||||||||||||||
Issuance
of compensatory options and warrants to consultants
|
-
|
-
|
-
|
-
|
330,215
|
-
|
-
|
-
|
-
|
330,215
|
|||||||||||||||||||||
Issuance
of common stock in payment
of interest on convertible notes
|
130,673
|
131
|
-
|
-
|
243,202
|
-
|
-
|
-
|
-
|
243,333
|
|||||||||||||||||||||
Issuance
of common stock to employees as bonus
|
101,850
|
102
|
-
|
-
|
544,427
|
-
|
-
|
-
|
-
|
544,529
|
|||||||||||||||||||||
Issuance
of common stock in settlement of lawsuit
|
118,936
|
119
|
-
|
-
|
180,664
|
-
|
-
|
-
|
-
|
180,783
|
|||||||||||||||||||||
Amortization
of deferred compensation expense
|
-
|
-
|
-
|
-
|
-
|
-
|
19,332
|
-
|
-
|
19,332
|
|||||||||||||||||||||
Realized
loss on sale of securities
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
|
3,646
|
3,646
|
|||||||||||||||||||||
Cumulative
translation adjustment
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
(13,671
|
)
|
-
|
(13,671
|
)
|
|||||||||||||||||||
Net
loss
|
-
|
-
|
-
|
-
|
-
|
(17,023,648
|
)
|
-
|
- |
-
|
(17,023,648
|
)
|
|||||||||||||||||||
Balance
at December 31, 2004
|
51,687,046
|
51,688
|
-
|
$
|
0
|
$
|
113,604,968
|
($102,245,183
|
)
|
$
|
0
|
($10,188
|
)
|
$
|
0
|
$
|
11,401,285
|
||||||||||||||
Issuance
of common stock upon
exercise of stock options and warrants
|
578,286
|
578
|
-
|
-
|
833,848
|
-
|
-
|
-
|
-
|
834,426
|
|||||||||||||||||||||
Issuance
of compensatory options and
warrants to consultants
|
-
|
-
|
-
|
-
|
82,210
|
-
|
-
|
-
|
-
|
82,210
|
|||||||||||||||||||||
Issuance
of common stock in payment of interest on convertible
notes
|
218,545
|
218
|
-
|
-
|
303,948
|
-
|
-
|
-
|
-
|
304,166
|
|||||||||||||||||||||
Amortization
of beneficial conversion feature,
discount and issuance costs related to preferred stock
|
-
|
-
|
-
|
-
|
(1,032,391
|
)
|
-
|
-
|
-
|
-
|
(1,032,391
|
)
|
|||||||||||||||||||
Issuance
of common stock upon conversion
of preferred stock, including dividends paid in stock
|
3,215,590
|
3,216
|
-
|
-
|
3,497,758
|
-
|
-
|
-
|
-
|
3,482,974
|
|||||||||||||||||||||
Discount
on preferred stock, including beneficial conversion features
and fair
value of detachable warrants
|
-
|
-
|
-
|
-
|
1,009,530
|
1,009,530
|
|||||||||||||||||||||||||
Cumulative
translation adjustment
|
592
|
592
|
|||||||||||||||||||||||||||||
Net
loss
|
(15,442,438
|
)
|
(15,442,438
|
)
|
|||||||||||||||||||||||||||
Balance
of December 31, 2005
|
55,699,467
|
55,700
|
-
|
-
|
118,281,871
|
(117,687,621
|
)
|
-
|
(9,596
|
)
|
-
|
640,354
|
|||||||||||||||||||
Issuance
of common stock upon
exercise of stock options
and warrants, net
|
208,095
|
208
|
-
|
-
|
97,108
|
-
|
-
|
-
|
-
|
97,316
|
|||||||||||||||||||||
Issuance
of compensatory options
to employees and
consultants
|
-
|
-
|
-
|
-
|
1,214,403
|
-
|
-
|
-
|
-
|
1,214,403
|
|||||||||||||||||||||
Issuance
of common stock in payment
of interest on
convertible notes
|
392,467
|
393
|
-
|
-
|
303,774
|
-
|
-
|
-
|
-
|
304,167
|
|||||||||||||||||||||
Issuance
of compensatory stock
to the board of directors
|
197,264
|
197
|
-
|
-
|
143,804
|
-
|
-
|
-
|
-
|
144,001
|
|||||||||||||||||||||
Issuance
of common stock from
private placement, net
of offering costs
|
22,664,191
|
22,664
|
-
|
-
|
16,318,993
|
-
|
-
|
-
|
-
|
16,341,657
|
|||||||||||||||||||||
Issuance
of common stock upon
conversion of preferred stock,
including dividends paid
in stock
|
1,124,421
|
1,125
|
-
|
-
|
873,875
|
-
|
-
|
-
|
-
|
875,000
|
|||||||||||||||||||||
Amortization
of beneficial conversion feature,
discount and issuance costs
related to preferred stock
|
(207,170
|
)
|
-
|
-
|
-
|
-
|
(207,170
|
)
|
|||||||||||||||||||||||
Discount
on Note payable for
issuance of warrants
|
138,000
|
-
|
-
|
-
|
-
|
138,000
|
|||||||||||||||||||||||||
Net
Loss
|
-
|
-
|
-
|
-
|
-
|
(8,043,253
|
)
|
-
|
-
|
-
|
(8,043,253
|
)
|
|||||||||||||||||||
Balance
at December 31, 2006
|
80,285,905
|
$ |
80,287
|
-
|
-
|
$
|
137,164,658
|
$
|
(125,730,874
|
)
|
-
|
$
|
(9,596
|
)
|
-
|
$
|
11,504,475
|
The
accompanying notes are an integral part of these consolidated financial
statements.
26
NexMed,
Inc.
Consolidated
Statements of Cash Flows
For
the Year Ended
|
|
|||||||||
|
|
December
31,
|
|
|||||||
|
|
2006
|
|
2005
|
|
2004
|
||||
Cash
flows from operating activities
|
||||||||||
Net
loss
|
$
|
(8,043,253
|
)
|
$
|
(15,442,438
|
)
|
$
|
(17,023,648
|
)
|
|
Adjustments
to reconcile net loss to net cash
|
||||||||||
used
in operating activities
|
||||||||||
Depreciation
and amortization
|
842,087
|
953,051
|
996,043
|
|||||||
Non-cash
interest, amortization of debt discount and
|
||||||||||
deferred
financing costs
|
328,050
|
315,512
|
254,682
|
|||||||
Non-cash
compensation expense
|
1,358,403
|
82,210
|
1,074,859
|
|||||||
Net
loss on sale of marketable securities
|
-
|
-
|
8,421
|
|||||||
Loss
on disposal of property and equipment
|
473,312
|
16,371
|
18,982
|
|||||||
Changes
in assets and liabilities
|
||||||||||
Decrease
(increase) in other receivable
|
398,740
|
(582,440
|
)
|
-
|
||||||
Decrease
in prepaid expense and other assets
|
209,037
|
1,025,579
|
82,912
|
|||||||
(Decrease)
increase in deferred revenue
|
(1,091,884
|
)
|
2,785,801
|
(128,708
|
)
|
|||||
(Decrease)
increase in payroll related liabilities
|
(979,104
|
)
|
858,011
|
(995,643
|
)
|
|||||
(Decrease)
increase in deferred compensation
|
(59,889
|
)
|
610,199
|
110,000
|
||||||
(Decrease)
increase in accounts payable and accrued expenses
|
(102,513
|
)
|
(457,577
|
)
|
374,318
|
|||||
Net
cash used in operating activities
|
(6,667,014
|
)
|
(9,835,721
|
)
|
(15,227,782
|
)
|
||||
Cash
flows from investing activities
|
||||||||||
Proceeds
from sale of fixed assets
|
178,769
|
-
|
-
|
|||||||
Capital
expenditures
|
(76,553
|
)
|
(160,694
|
)
|
(145,809
|
)
|
||||
Proceeds
from collection of note receivable
|
-
|
-
|
48,341
|
|||||||
Purchases
of short term investments and marketable securities
|
(6,000,000
|
)
|
(1,500,000
|
)
|
(1,897,584
|
)
|
||||
Proceeds
from sale/redemption of certificates of deposits,
|
||||||||||
marketable
securities and short term investments
|
5,500,000
|
2,384,000
|
1,010,079
|
|||||||
Net
cash (used in) provided by investing activities
|
(397,784
|
)
|
723,306
|
(984,973
|
)
|
|||||
Cash
flows from financing activities
|
||||||||||
Issuance
of common stock, net of offering costs
|
16,341,657
|
-
|
14,205,686
|
|||||||
Proceeds
from exercise of stock options and warrants
|
97,316
|
834,426
|
187,672
|
|||||||
Issuance
of preferred stock, net of offering costs
|
-
|
4,219,969
|
-
|
|||||||
Redemption
of preferred stock
|
-
|
(92,027
|
)
|
-
|
||||||
Issuance
of notes payable, net of debt issue costs
|
1,975,000
|
-
|
-
|
|||||||
Repayment
of convertible notes payable
|
(3,000,000
|
)
|
-
|
-
|
||||||
Principal
payments on capital lease obligations
|
(233,823
|
)
|
(644,049
|
)
|
(898,861
|
)
|
||||
Net
cash provided by financing activities
|
15,180,150
|
4,318,319
|
13,494,497
|
|||||||
Effect
of foreign exchange on cash
|
-
|
592
|
(13,671
|
)
|
||||||
Net
increase (decrease) in cash and cash equivalents
|
8,115,352
|
(4,793,504
|
)
|
(2,731,929
|
)
|
|||||
Cash
and cash equivalents
|
||||||||||
Beginning
of year
|
2,953,781
|
7,747,285
|
10,479,214
|
|||||||
End
of year
|
$
|
11,069,133
|
$
|
2,953,781
|
$
|
7,747,285
|
||||
Cash
paid for interest
|
$
|
91,912
|
$
|
40,185
|
$
|
120,962
|
||||
Supplemental
disclosure of non-cash investing and financing activities:
|
||||||||||
Payment
of interest in common stock
|
304,167
|
304,166
|
243,333
|
|||||||
Conversion
of preferred stock to common stock
|
859,736
|
3,359,648
|
-
|
|||||||
Preferred
stock dividend paid in common stock
|
15,264
|
123,326
|
-
|
|||||||
Amortization
of debt discount
|
10,615
|
-
|
-
|
|||||||
Deemed
dividend to preferred shareholders
|
984,715
|
-
|
The
accompanying notes are an integral part of these consolidated financial
statements.
27
NexMed,
Inc.
Notes
to Consolidated Financial Statements
1.
|
Organization
and Basis of
Presentation
|
The
Company was incorporated in Nevada in 1987. In January 1994, the Company
began
research and development of a device for the treatment of herpes simplex.
The
Company, since 1995, has conducted research and development both domestically
and abroad on proprietary pharmaceutical products, with the goal of growing
through acquisition and development of pharmaceutical products and
technology.
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 $125,730,874 at December 31, 2006 and expects that it will incur
additional losses in the future completing the research, development and
commercialization of its technologies. These circumstances raise substantial
doubt about the Company's ability to continue as a going concern. Management
anticipates that the Company will require additional financing, which it
is
actively pursuing, to fund operations, including continued research, development
and clinical trials of the Company’s product candidates. 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. If
the
Company is unable to obtain additional financing, operations will need to
be
discontinued. The financial statements do not include any adjustments that
might
result from the outcome of this uncertainty.
2. |
Summary
of Significant Accounting
Principles
|
Significant
accounting principles followed by the Company in preparing its financial
statements are as follows:
Principles
of consolidation
The
consolidated financial statements include the accounts of the Company and
its
wholly owned subsidiaries. All significant intercompany accounts and
transactions have been eliminated.
Translation
of foreign currencies
Assets
and liabilities of the Company’s foreign subsidiaries are translated to United
States dollars based on exchange rates at the end of the reporting period.
Income and expense items are translated at average exchange rates prevailing
during the reporting period. Translation adjustments are accumulated in a
separate component of stockholder’s equity. Transaction gains or losses are
included in the determination of operating results.
Cash
and cash equivalents
For
purposes of the balance sheets and the statements of cash flows, cash
equivalents represent all highly liquid investments with an original maturity
date of three months or less.
Marketable
securities and short term investments
Marketable
securities consist of high quality corporate and government securities, which
have original maturities of more than three months, at the date of purchase,
and
equity investments in publicly-traded companies. The Company classifies all debt
securities and equity securities with readily determinable market value as
“available for sale” in accordance with SFAS No. 115, “Accounting for Certain
Investments in Debt and Equity Securities.” These investments are carried at
fair market value with unrealized gains and losses reported as a separate
component of stockholders’ equity. Gross realized losses were $0, $0, and $8,421
for 2006, 2005 and 2004 respectively. For the purpose of determining realized
gains and losses, the cost of securities sold was based on specific
identification. The Company reviews investments on a quarterly basis for
reductions in market value that are other than temporary. When such reductions
occur, the cost of the investment is adjusted to its fair value through a
charge
to other income (expense) in the periods incurred.
28
NexMed,
Inc.
Notes
to Consolidated Financial Statements
A
significant amount of our short term investments are comprised of investment
grade variable rate debt obligations, which are asset-backed and categorized
as
available-for-sale. Accordingly, our investments in these securities are
recorded at cost, which approximates fair value due to their variable interest
rates, which typically reset every 28 days. Despite the long-term nature
of
their contractual maturities, we have the ability and intent to liquidate
these
securities within one year. As a result of the resetting variable rates,
we had
no cumulative gross unrealized or realized holding gains or losses from these
investments. All income generated from these investments was recorded as
interest income.
Fair
value of financial instruments
The
carrying value of cash and cash equivalents, convertible notes payable, accounts
payable and accrued expenses and deferred compensation approximates fair
value
due to the relatively short maturity of these instruments.
Fixed
assets
Property
and equipment are stated at cost less accumulated depreciation. Depreciation
of
equipment and furniture and fixtures is provided on a straight-line basis
over
the estimated useful lives of the assets, generally three to ten years.
Depreciation of buildings is provided on a straight-line basis over the
estimated useful life of 31 years. Amortization of leasehold improvements
is
provided on a straight-line basis over the shorter of their estimated useful
life or the lease term. The costs of additions and betterments are capitalized,
and repairs and maintenance costs are charged to operations in the periods
incurred.
Long-lived
assets
The
Company reviews for the impairment of long-lived assets whenever events or
circumstances indicate that the carrying amount of an asset may not be
recoverable. An impairment loss would be recognized when estimated undiscounted
future cash flows expected to result from the use of the asset and its eventual
disposition is less than its carrying amount. If such assets are considered
impaired, the amount of the impairment loss recognized is measured as the
amount
by which the carrying value of the asset exceeds the fair value of the asset,
fair value being determined based upon discounted cash flows or appraised
values, depending on the nature of the asset. No such impairment losses have
been recorded by the Company during 2006, 2005 or 2004.
Revenue
recognition
Revenues
from product sales are recognized upon delivery of products to customers,
less
allowances for estimated returns and discounts. Royalty revenue is recognized
upon the sale of the related products, provided the royalty amounts are fixed
or
determinable and the amounts are considered collectible.
Revenues
earned under licensing and research and development contracts are recognized
in
accordance with the cost-to-cost method outlined in Staff Accounting Bulletin
No. 101, as amended, whereby the extent of progress toward completion is
measured on the cost-to-cost basis; however, revenue recognized at any point
will not exceed the cash received. When the current estimates of total contract
revenue and contract cost indicate a loss, a provision for the entire loss
on
the contract is made in the period which it becomes probable. All costs related
to these agreements are expensed as incurred and classified within “Research and
development” expenses in the Consolidated Statement of Operations and
Comprehensive Income.
29
NexMed,
Inc.
Notes
to Consolidated Financial Statements
Also,
licensing agreements typically include several elements of revenue, such
as
up-front payments, milestones, royalties upon sales of product, and the delivery
of product and/or research services to the licensor. We follow the accounting
guidance of SEC Staff Accounting Bulletin No. 104 (which superseded SEC
Staff Accounting Bulletin No. 101) (“SAB 104”), an analogy to EITF
No. 91-6 and EITF No. 00-21 (which became effective for contracts entered
into after June 2003). Non-refundable license fees received upon execution
of
license agreements where we have continuing involvement are deferred and
recognized as revenue over the estimated performance period of the agreement.
This requires management to estimate the expected term of the agreement or,
if
applicable, the estimated life of its licensed patents.
In
addition, EITF No. 00-21 requires a company to evaluate its arrangements
under
which it will perform multiple revenue-generating activities. For example,
a
license agreement with a pharmaceutical company may involve a license, research
and development activities and/or contract manufacturing. Management is required
to determine if the separate components of the agreement have value on a
standalone basis and qualify as separate units of accounting, whereby
consideration is allocated based upon their relative “fair values” or, if not,
the consideration should be allocated based upon the “residual method.”
Accordingly, up-front and development stage milestone payments will be deferred
and recognized as revenue over the performance period of such license
agreement.
Research
and development
Research
and development costs are expensed as incurred and include the cost of salaries,
building costs, utilities, allocation of indirect costs, and expenses to
third
parties who conduct research and development, pursuant to development and
consulting agreements, on behalf of the Company.
Income
taxes
Income
taxes are accounted for under the asset and liability method. Deferred income
taxes are recorded for temporary differences between financial statement
carrying amounts and the tax bases of assets and liabilities. Deferred tax
assets and liabilities reflect the tax rates expected to be in effect for
the
years in which the differences are expected to reverse. A valuation allowance
is
provided if it is more likely than not that some or all of the deferred tax
assets will not be realized.
Loss
per common share
Basic
earnings per share is computed by dividing income available to common
stockholders by the weighted average number of common shares outstanding
during
the period. Diluted earnings per share gives effect to all dilutive potential
common shares outstanding during the period. The computation of diluted earnings
per share does not assume conversion, exercise or contingent exercise of
securities that would have an antidilutive effect on per share
amounts.
At
December 31, 2006, 2005 and 2004, outstanding options to purchase 3,613,421,
5,018,880, and 5,215,081 shares of common stock, respectively, with exercise
prices ranging from $.55 to $16.25 have been excluded from the computation
of
diluted loss per share as they are antidilutive. At December 31, 2006, 2005
and
2004, outstanding warrants to purchase 20,031,694, 11,030,550, and 11,436,691
shares of common stock, respectively, with exercise prices ranging from $0.55
to
$4.04 have also been excluded from the computation of diluted loss per share
as
they are antidilutive. Promissory notes convertible into 600,000 shares of
common stock in 2006 and 1,200,000 shares of common stock (see Note 6) in
2005
and 2004 have also been excluded from the computation of diluted loss per
share,
as they are antidilutive. Series C 6% cumulative convertible preferred stock
(see Note 11) convertible into 643,382 shares of common stock in 2005 have
also
been excluded from the computation of diluted loss per share, as it is
antidilutive.
30
NexMed,
Inc.
Notes
to Consolidated Financial Statements
Accounting
for stock based compensation
Effective
January 1, 2006, the Company adopted the provisions of Statement of Financial
Accounting Standards No. 123R, “Share-Based Payment” (“SFAS
123R”), which establishes the financial accounting and reporting standards
for stock-based compensation plans. SFAS 123R requires the measurement and
recognition of compensation expense for all stock-based awards made to employees
and directors, including employee stock options. Under the provisions of
SFAS 123R, stock-based compensation cost is measured at the grant date,
based on the calculated fair value of the award, and is recognized as an
expense
on a straight-line basis over the
requisite service period of the entire award (generally the vesting period
of
the award). The Company adopted the provisions of SFAS 123R as of January
1,
2006 using the modified prospective transition method. Under this transition
method, stock-based compensation expense for the year ended December 31,
2006
includes expense for all equity awards granted during the year ended December
31, 2006 and prior, but not yet vested as of January 1, 2006, based on the
grant
date fair value estimated in accordance with the original provisions of
SFAS No. 123, “Accounting for Stock-Based Compensation” (“SFAS 123,”)
as amended by SFAS 148, “Accounting for Stock-Based Compensation—Transition and
Disclosure.” Also in accordance with the modified prospective transition method,
prior interim and annual periods have not been restated and do not reflect
the
recognition of stock-based compensation cost under SFAS 123R. Since the adoption
of SFAS 123R, there have been no changes to the Company’s stock compensation
plans or modifications to outstanding stock-based awards which would increase
the value of any awards outstanding. Compensation expense for all stock-based
compensation awards granted subsequent to January 1, 2006 was based on the
grant-date fair value determined in accordance with the provisions of SFAS
123R.
The
Company accounts for stock options granted to non-employees on a fair value
basis in accordance with SFAS No. 123, “Accounting for Stock-Based
Compensation,” and Emerging Issues Task Force Issue No. 96-18, “Accounting for
Equity Instrument That Are Issued to Other Than Employees for Acquiring,
or in
Conjunction with Selling, Goods or Services.” Any options issued to
non-employees are recorded in the consolidated financial statements in
deferred
expenses in stockholders’ equity using the fair value method and then amortized
to expense over the applicable service periods (See Note 8). As a result,
the
non-cash charge to operations for non-employee options with vesting or
other
performance criteria is valued each reporting period based upon changes
in the
fair value of the Company’s common stock.
As
a
result of adopting SFAS 123R, the Company’s net loss and its non cash
compensation expense as shown in the Consolidated Statements of Operations
for
the year ended December 31, 2006 is $1,250,403 more than if the Company had
continued to account for stock-based compensation under Accounting Principles
Board Opinion No. 25, “Accounting for Stock Issued to Employees” (“APB 25”)
and its related interpretations. Basic and diluted net loss per share for
the
year ended December 31, 2006 of $(0.12) is $0.02 more than if the Company
had
not adopted SFAS 123R.
31
NexMed,
Inc.
Notes
to Consolidated Financial Statements
Prior
to
January 1, 2006, the Company accounted for stock-based compensation in
accordance with APB 25 and also followed the disclosure requirements of
SFAS 123. Under APB 25, the Company accounted for stock-based awards to
employees and directors using the intrinsic value method as allowed under
SFAS
123. Under the intrinsic value method, no stock-based compensation expense
had
been recognized in the Company’s Statement of Operations because the exercise
price of the Company’s stock options granted to employees and directors equaled
the fair market value of the underlying stock at the date of grant. The
following table sets forth the computation of basic and diluted loss per
share
for years ended December 31, 2005 and 2004 and illustrates the effect on
net
loss and loss per share as if the Company had applied the fair value recognition
provisions of SFAS 123 to its stock plans:
For
the year ended
|
|||||||
2005
|
|
2004
|
|||||
Net
loss applicable to common stock, as reported
|
$
|
(16,550,479
|
)
|
$ | (17,023,648 | ) | |
Add:
Stock-based compensation expense included
|
|||||||
in
reported net loss
|
82,210
|
355,800
|
|||||
Deduct:
Total stock-based compensation expense determined
|
|||||||
under
fair-value based method for all awards
|
(1,147,979
|
)
|
(1,672,545
|
)
|
|||
Proforma
net loss applicable to common stock
|
$
|
(17,616,248
|
)
|
$
|
(18,340,393
|
)
|
|
Basic
and diluted loss per share:
|
|||||||
As
reported
|
$
|
(0.32
|
)
|
$
|
(0.39
|
)
|
|
Proforma
|
$
|
(0.34
|
)
|
$
|
(0.42
|
)
|
The
following table indicates where the total stock-based compensation expense
resulting from stock options and awards appears in the Statement of
Operations:
Year
Ended
December
31,
2006
|
||||
General
and administrative
|
$
|
1,235,603
|
||
Research
and development
|
122,800
|
|||
Stock-based
compensation expense
|
1,358,403
|
32
NexMed,
Inc.
Notes
to Consolidated Financial Statements
The
stock-based compensation expense has not been tax-effected due to the recording
of a full valuation allowance against U.S. net deferred tax assets.
The
fair
value of each stock option grant is estimated on the grant date using the
Black-Scholes option-pricing model with the following assumptions used for
the
years ended December 31, 2006 and 2005:
Dividend
yield
|
0.00
|
%
|
||
Risk-free
yields
|
4.15
-5.10
|
%
|
||
Expected
volatility
|
80
|
%
|
||
Expected
option life
|
1
- 6 years
|
|||
Forfeiture
rate
|
6.41
|
%
|
Expected
Volatility.
The
Company uses analysis of historical volatility to compute the expected
volatility of its stock options.
Expected
Term. The
expected term is based on several factors including historical observations
of
employee exercise patterns during the Company’s history and expectations of
employee exercise behavior in the future giving consideration to the contractual
terms of the stock-based awards.
Risk-Free
Interest Rate.
The
interest rate used in valuing awards is based on the yield at the time of
grant
of a U.S. Treasury security with an equivalent remaining term.
Dividend
Yield.
The
Company has never paid cash dividends, and does not currently intend to pay
cash
dividends, and thus has assumed a 0% dividend yield.
Pre-Vesting
Forfeitures.
Estimates of pre-vesting option forfeitures are based on Company experience.
The
Company will adjust its estimate of forfeitures over the requisite service
period based on the extent to which actual forfeitures differ, or are expected
to differ, from such estimates. Changes in estimated forfeitures will be
recognized through a cumulative catch-up adjustment in the period of change
and
will also impact the amount of compensation expense to be recognized in future
periods. The cumulative effect resulting from initially applying the provisions
of SFAS 123R to nonvested equity awards was not significant.
Additional
disclosures required under SFAS 123R are presented in Note 9.
Concentration
of credit risk
From
time
to time, the Company maintains cash in bank accounts that exceed the FDIC
insured limits. The Company has not experienced any losses on its cash accounts.
Comprehensive
loss
The
Company has recorded comprehensive loss in accordance with Statement of
Financial Accounting Standards (“SFAS”) No. 130, “Reporting Comprehensive
Income” (“SFAS 130”), which requires the presentation of the components of
comprehensive loss in the Company’s financial statements. Comprehensive loss is
defined as the change in the Company’s equity during a financial reporting
period from transactions and other circumstances from non-owner sources
(including cumulative translation adjustments and unrealized gains/losses
on
available for sale securities). Accumulated other comprehensive (loss) income
included in the Company’s balance sheet is comprised of translation adjustments
from the Company’s foreign subsidiaries and unrealized gains and losses on
investment in marketable securities.
33
NexMed,
Inc.
Notes
to Consolidated Financial Statements
Accounting
estimates
The
preparation of financial statements in conformity with accounting principles
generally accepted in the United States requires management to make estimates
that affect the reported amounts of assets and liabilities at the date of
the
financial statements and the reported amounts of revenues and expenses during
the reporting period. The Company’s most significant estimates relate to the
valuation of its long-lived assets, estimated cost to complete under its
research contracts, and valuation allowances for its deferred tax benefit.
Actual results may differ from those estimates.
Recent
accounting pronouncements
In
July
2006, the Financial Accounting Standards Board (“FASB”) issued Interpretation
No. 48, “Accounting
for Uncertainty in Income Taxes—an interpretation of FASB Statement No.
109”
(“FIN
48”), which clarifies the accounting for uncertainty in tax positions. This
Interpretation requires an entity to recognize the impact of a tax position
in
its financial statements if that position is more likely than not to be
sustained on audit based on the technical merits of the position. The provisions
of FIN 48 are effective as of the beginning of fiscal year 2007, with the
cumulative effect of the change in accounting principle recorded as an
adjustment to opening retained earnings. The Company has evaluated the
effect of implementing this Interpretation and does not expect the adoption
to
have a material impact on its financial condition and results of
operations.
In
September 2006, the SEC issued Staff Accounting Bulletin No. 108,
“Considering the Effects of Prior Year Misstatements when Quantifying
Misstatements in Current Year Financial Statements” (“SAB 108”), to address
diversity in practice in quantifying financial statement misstatements. SAB
108
requires that the Company quantify misstatements based on their impact on
each
of its financial statements and related disclosures. The Company has evaluated
the effect of implementing this SAB and does not expect the adoption to have
a
material impact on its financial condition and results of operations.
In
September 2006, the Financial Accounting Standards Board ("FASB") issued
FASB
Statement No. 157, Fair
Value Measurements ("SFAS
157"), which defines fair value, establishes a framework for measuring fair
value in generally accepted accounting principles, and expands disclosures
about
fair value measurements. This Statement is effective for financial
statements issued for fiscal years beginning after November 15, 2007, and
interim periods within those fiscal years. Earlier application is
encouraged, provided that the reporting entity has not yet issued financial
statements for that fiscal year, including financial statements for an interim
period within that fiscal year. The Company is in the process of
evaluating the impact that the adoption of SFAS 157 will have on its financial
position and results of operations.
3. |
Licensing
and Research and Development
Agreements
|
On
September 15, 2005, the Company signed an exclusive global licensing agreement
with Novartis International Pharmaceutical Ltd., (“Novartis”) for its
anti-fungal product, NM100060. Under the agreement, Novartis acquired the
exclusive worldwide rights to NM100060 and would assume all further development,
regulatory, manufacturing and commercialization responsibilities as well
as
costs. Novartis agreed to pay the Company up to $51 million in upfront and
milestone payments on the achievement of specific development and regulatory
milestones, including an initial cash payment of $4 million at signing. In
addition, the Company is eligible to receive royalties based upon the level
of
sales achieved and is entitled to receive reimbursements of third party
preclinical study costs up to $3.25 million. The
Company is recognizing the initial up front and preclinical reimbursement
revenue from this agreement based on the cost-to-cost method over the 32-month
period estimated to complete the remaining preclinical studies for NM100060.
The
entire amount of $183,700 in other receivables in the Consolidated Balance
Sheet
represents amounts billed during the three months ended December 31, 2006
for
the reimbursement of preclinical study costs and patent expenses. Of the
$5,708,375 received since September 15, 2005 through December 31, 2006, the
Company has recognized licensing revenue in the amount of $1,726,684 for
the
year ended December 31, 2006, and $4,014,458 to date. The balance of $1,693,917
is recorded as deferred revenue in the Consolidated Balance Sheet and will
be
recognized over the remaining life of the preclinical studies that will be
completed by the Company on or before June 30, 2008.
34
NexMed,
Inc.
Notes
to Consolidated Financial Statements
On
February 16, 2007, the Novartis agreement was amended. Pursuant to the
amendment, the Company is no longer obligated to complete the remaining
preclinical studies for NM100060. Novartis has taken over all responsibilities
related to the remaining preclinical studies. As such, the balance of deferred
revenue of $1,693,917 at December 31, 2006 will be recognized as revenue
on a
straight line basis over the 18 month period ended June 30, 2008 which is
the
estimated performance period for Novartis to complete the remaining preclinical
studies.
On
July
1, 2004, the Company entered into a license, supply and distribution agreement
with Schering AG, Germany (“Schering”). This agreement provided Schering with
exclusive commercialization rights to Alprox-TD®
in
approximately 75 countries outside of the U.S. On June 20, 2006, Schering
elected to terminate the agreement without cause. Pursuant to the agreement,
Schering was obligated to pay the Company a termination fee of 500,000 Euros
or
approximately $627,000. This amount was received in August 2006 and is recorded
as other income in the Consolidated Statements of Operations for the year
ended
December 31, 2006.
In
October 2005, the Company entered into an agreement with a Japanese
pharmaceutical company whereby NexMed would provide contract development
services for a tape/patch treatment for chronic pain. The Company received
$100,000 as a signing payment. In December 2005, the Company ceased all
development work on this project. The $100,000 signing payment which was
recorded as deferred revenue in the December 31, 2005 Consolidated Balance
Sheet
was recognized as revenue in 2006 when the Japanese partner agreed to and
the
Company completed the technology transfer of development work done to date.
In
November 2003, the Company entered into an agreement with a Japanese
pharmaceutical company whereby NexMed would provide contract development
services for an innovative topical treatment for a form of herpes. The
Company received $100,000 as a signing payment in 2003, approximately $87,000
of
which the Company recognized as revenue in 2004 and approximately $13,000
of
which it recognized as revenue in 2003.
In 2004,
the Company recognized revenue of approximately $217,000 and incurred expenses
of approximately $116,000 related to this agreement. The $217,000 of revenue
consisted of the $87,000 deferred from 2003 and $130,000 in milestone payments
received in 2004. In September of 2004, the Company completed all development
work for this project and will recognize no further revenue.
35
NexMed,
Inc.
Notes
to Consolidated Financial Statements
In
November 2003, the Company entered into an R&D agreement with a Japanese
pharmaceutical company to develop a new local anesthetics gel designed for
pain
relief associated with dental procedures, superficial skin surgery and skin
graft harvesting, and needle insertions. The Company recognized revenue of
approximately $41,000 in 2004 and $5,000 in 2003 related to this project.
In
2004, the Company incurred expenses of approximately $32,000, completed all
development work and will recognize no further revenue related to this
project.
In
October 2003, the Company entered into an R&D agreement with a Japanese
pharmaceutical company to develop a tape/patch treatment for chronic pain.
The
Company recognized revenue of approximately $21,000 in 2003. The second
milestone payment of approximately $69,000 was received and recognized as
research and development fee revenue in 2004. In 2004, the Company incurred
expenses of approximately $40,500 related to this agreement and completed
the
first phase of development.
Upon
completion of the first phase of development, the development partner
decided
to suspend all remaining development work on this project due
to
new regulatory developments in Japan.
As such,
there will be no additional revenue from the Japanese pharmaceutical company
should the
Company
continue
to develop this product further.
In
August
2003, the Company entered into an R&D agreement with a Japanese
pharmaceutical company to develop NM 20138, a new once-a-day patch treatment
for
bronchial asthma, which incorporates an off-patent anti-asthmatic drug compound
and the NexACT®
technology. The Company recognized revenue related to this project of
approximately $21,000 in 2003. The second milestone payment of approximately
$23,000 was received and recognized as research and development fee revenue
in
2004. In 2004, the
Company incurred expenses of approximately $62,000 related to this agreement
and
completed the first phase of development. Upon completion of the first phase
of
development, the partner elected not to take the project to the next stage
of
development due to proprietary reasons. As
such,
there will be no additional revenue from the Japanese pharmaceutical company
should the Company continue to develop this product further. The Company
negotiated and received a
one-time
payment of $90,538 upon cancellation of this agreement, which amount is recorded
in other income (expense) for 2003 in the Company’s Consolidated Statement of
Operations.
4. |
Fixed
Assets
|
Fixed
assets at December 31, 2006 and 2005 were comprised of the
following:
2006
|
|
2005
|
|||||
Land
|
363,909
|
363,909
|
|||||
Building
|
7,317,865
|
7,425,540
|
|||||
Machinery
and equipment
|
2,642,030
|
2,640,731
|
|||||
Capital
lease - Equipment
|
-
|
1,310,815
|
|||||
Computer
software
|
596,605
|
596,605
|
|||||
Furniture
and fixtures
|
196,027
|
342,094
|
|||||
Leasehold
improvements
|
-
|
640,322
|
|||||
11,116,436
|
13,320,016
|
||||||
Less:
accumulated depreciation
|
(3,628,336
|
)
|
(4,414,300
|
)
|
|||
$
|
7,488,100
|
$
|
8,905,716
|
36
NexMed,
Inc.
Notes
to Consolidated Financial Statements
Depreciation
and amortization expense was $842,087, $953,051, and $996,043 for 2006, 2005
and
2004 respectively, of which $188,825, $378,789, and $410,833 related to capital
leases for the respective years. Accumulated amortization of assets under
capital leases was $0, $747,005 and $1,207,027 at December 31, 2006, 2005,
and
2004, respectively.
5. |
Deferred
Compensation
|
On
February 27, 2002, the Company entered in to an employment agreement with
Y.
Joseph Mo, Ph.D., that has a constant term of five years, and pursuant to
which
Dr. Mo served as the Company's Chief Executive Officer and President. Under
the
employment agreement, Dr. Mo is entitled to deferred compensation in an annual
amount equal to one sixth of the sum of his base salary and bonus for the
36
calendar months preceding the date on which the deferred compensation payments
commence subject to certain limitations, including annual vesting through
January 1, 2007, as set forth in the employment agreement. The deferred
compensation will be payable monthly for 180 months commencing on termination
of
employment. Dr. Mo’s employment was terminated as of December 15, 2005. The
monthly deferred compensation payment through May 15, 2021 will be $9,158.
As of
December 31, 2006 and 2005, the Company has accrued $1,058,098 and $1,178,197
respectively, which is included in deferred compensation, based upon the
estimated present value of the vested portion of the obligation.
6. |
Convertible
Notes Payable
|
On
December 12, 2003, the Company issued convertible notes (the “Notes”) in an
aggregate principal amount of $6 million. The Notes are payable in two
installments of $3 million on November 30, 2006 and May 31, 2007 and are
collateralized by the Company’s facility in East Windsor, New Jersey which has a
carrying value of approximately $6.9 million. The Notes were initially
convertible into shares of the Company’s common stock at a conversion price
initially equal to $6.50 per share (923,077 shares). Pursuant to the terms
of
the Notes, the conversion price was adjusted on June 14, 2004 to the greater
of
(i) the volume weighted average price of the Company’s stock over the six-month
period ending on such date and (ii) $5.00. Since the volume weighted average
price of the Company’s stock during this period was below $5.00, the conversion
price was adjusted to $5.00 (1,200,000 shares). Interest accretes on the
Notes
on a semi-annual basis at a rate of 5% per annum, and the Company may pay
such
amounts in cash or by effecting the automatic conversion of such
amount
into the
Company’s common stock at a 5% premium to the then average market prices.
In
April
and October 2006, respectively, the Company issued 164,855 shares and 227,612
shares of its common stock as payment of an aggregate of $304,167 in interest
on
the Notes. During 2005 and 2004, the Company issued 218,545 and 130,673 of
shares of its common stock as payment of interest on the Notes.
On
November 30, 2006, the Company paid in cash the $3 million installment due
plus
accrued interest of $25,417. The remaining $3 million balance plus accrued
interest on the Note is payable on May 31, 2007.
For
the
years ended December 31, 2006 and 2005, the Company recorded amortization
of the
debt issuance costs of $11,345 in each year.
7. |
Note
Payable
|
On
November 30, 2006, the Company issued a Note in principal amount of $2 million.
The Note is payable on the earlier of December 31, 2007 or the closing by
the
Company on the sale of the Company’s facility in East Windsor, New Jersey.
Interest accretes on the Note on a quarterly basis at a rate of 7.5% per
annum
provided, however, if the Company has not entered into a contract of sale
of the
East Windsor property on or prior to May 31, 2007, and the Note has not be
repaid by such date, the interest rate will increase to 8.5%.
37
NexMed,
Inc.
Notes
to Consolidated Financial Statements
The
Company also issued the Note holder a 4-year detachable warrant to purchase
500,000 shares of common stock at an exercise price of $0.5535. The Company
valued the warrants using the Black-Scholes pricing model. The Company allocated
a relative fair value of $138,000 to the warrants. The relative fair value
of
the warrants is allocated to additional paid in capital and treated as a
discount to the Note that is being amortized over the 13-month period ended
December 31, 2007.
For
the
year ended December 31, 2006, the Company recorded $10,615 of amortization
related to the Note discount.
8. |
Line
of Credit
|
In
February 2001, the Company entered into a financial arrangement with GE Capital
Corporation for a line of credit, which provided for the financing of up
to $5
million of equipment (i) for its new East Windsor, NJ manufacturing facility
and
(ii) for its expanded corporate and laboratory facilities in Robbinsville,
NJ.
Equipment financed through this facility was in the form of a 42-month capital
lease. As of March 31, 2002, the date this line of credit expired, the Company
had financed $1,113,459
of equipment purchases. The balance due under this facility was fully paid
in
the second quarter of 2005.
In
January 2002, GE approved a new credit line, which provided for the financing
of
up to $3 million of equipment and expired on December 31, 2002. During 2002,
the
Company accessed $1,111,427 of the credit line. The balance due under this
facility was fully paid in the first quarter of 2006.
In
July
2003, GE approved a new credit line, which expired on July 2004 and provided
for
the financing of up to $1.85 million of equipment. During 2003 and 2004,
the
Company accessed $738,731 of this credit line. The balance due under this
facility was fully paid in the fourth quarter of 2006.
9. |
Stock
Options and Restricted
Stock
|
During
December 1996, the Company adopted The NexMed, Inc. Stock Option and Long-Term
Incentive Compensation Plan (“the Incentive Plan”) and The NexMed, Inc.
Recognition and Retention Stock Incentive Plan (“the Recognition Plan”). A total
of 2,000,000 shares were set aside for these two plans. In May 2000, the
Stockholders’ approved an increase in the number of shares reserved for the
Incentive Plan and Recognition Plan to a total of 7,500,000. During June
2006,
the Company adopted the NexMed, Inc. 2006 Stock Incentive Plan. A total of
3,000,000 shares were set aside for the plan. Options granted under the
Company’s plans generally vest over a period of one to five years, with exercise
prices of currently outstanding options ranging between $0.55 to $16.25.
The
maximum term under these plans is 10 years.
38
NexMed,
Inc.
Notes
to Consolidated Financial Statements
The
following table summarizes information about options outstanding at December
31,
2006:
Options
Outstanding
|
Options
Exercisable
|
|||||||||||||||||||||
|
|
Weighted
|
Weighted
|
|
|
Weighted
|
|
|||||||||||||||
|
|
Average
|
Average
|
Aggregate
|
|
Average
|
Aggregate
|
|||||||||||||||
Range
of
|
Number
|
Remaining
|
Exercise
|
Intrinsic
|
Number
|
Exercise
|
Intrinsic
|
|||||||||||||||
Exercise
Prices
|
Outstanding
|
Contractual
Life
|
Price
|
Value
|
Exercisable
|
Price
|
Value
|
|||||||||||||||
$
.55 - 1.85
|
2,879,270
|
8.56
years
|
$
|
0.84
|
$
|
28,462
|
1,686,747
|
$
|
0.84
|
$
|
28,462
|
|||||||||||
2.00
- 3.99
|
306,950
|
2.28
years
|
2.44
|
-
|
306,950
|
2.44
|
-
|
|||||||||||||||
4.00
- 5.50
|
382,801
|
5.47
years
|
4.64
|
-
|
357,800
|
4.63
|
-
|
|||||||||||||||
7.00
- 8.00
|
15,000
|
3.38
years
|
8.00
|
-
|
15,000
|
8.00
|
-
|
|||||||||||||||
12.00
- 16.25
|
29,400
|
3.78
years
|
14.73
|
-
|
29,400
|
14.73
|
-
|
|||||||||||||||
3,613,421
|
$
|
1.52
|
$
|
28,462
|
2,395,897
|
$
|
1.83
|
$
|
28,462
|
A
summary
of stock option activity is as follows:
|
|
Weighted
|
|
Weighted
|
|
Total
|
|
||||||
|
|
|
|
Average
|
|
Average
Remaining
|
|
Aggregate
|
|
||||
|
|
Number
of
|
|
Exercise
|
|
Contractual
|
|
Intrinsic
|
|
||||
|
|
Shares
|
|
Price
|
|
Life
|
|
Value
|
|||||
Outstanding
at January 1, 2004
|
5,414,617
|
$
|
2.94
|
||||||||||
Granted
|
731,150
|
2.41
|
|||||||||||
Exercised
|
(192,986
|
)
|
0.90
|
||||||||||
Cancelled
|
(737,700
|
)
|
3.22
|
||||||||||
Outstanding
at December 31, 2004
|
5,215,081
|
$
|
2.91
|
||||||||||
Granted
|
400,650
|
1.03
|
|||||||||||
Exercised
|
(106,400
|
)
|
1.08
|
||||||||||
Cancelled
|
(490,451
|
)
|
2.62
|
||||||||||
Outstanding
at December 31, 2005
|
5,018,880
|
$
|
2.83
|
||||||||||
Granted
|
1,993,750
|
0.78
|
|||||||||||
Exercised
|
(354,666
|
)
|
0.71
|
||||||||||
Cancelled
|
(3,044,543
|
)
|
3.28
|
||||||||||
Outstanding
at December 31, 2006
|
3,613,421
|
$
|
1.52
|
7.64
years
|
$
|
28,462
|
|||||||
Vested
or expected to vest at
|
|||||||||||||
December
31, 2006
|
3,381,801
|
$
|
1.52
|
7.64
years
|
$
|
28,462
|
|||||||
Exercisable
at December 31, 2006
|
2,395,897
|
$
|
1.83
|
6.96
years
|
$
|
28,462
|
|||||||
Exercisable
at December 31, 2005
|
4,443,730
|
$
|
2.94
|
||||||||||
Exercisable
at December 31, 2004
|
3,975,628
|
$
|
2.93
|
||||||||||
Options
available for grant at December 31, 2006
|
1,833,368
|
The
weighted average grant date fair value of options granted during 2006, 2005
and
2004 was $0.78, $1.03, and $2.46, respectively. The intrinsic value of options
exercised during the year ended December 31, 2006 was $108,328.
39
NexMed,
Inc.
Notes
to Consolidated Financial Statements
As
of
December 31, 2006, there was $422,156 of total unrecognized compensation
cost
related to non-vested stock options. That cost is expected to be recognized
over
a weighted-average period of 1.19 years.
Principal
employee based compensation transactions for the year ended December 31,
2006
were as follows:
On
September 26, 2006, the Company issued a total of 350,000 shares of restricted
stock with a fair value of $217,000 to employees. These shares vested on
January
2, 2007 assuming continuous and uninterrupted service with the Company. 344,000
of these shares vested on January 2, 2007. Accordingly, the Company recorded
$203,090 in compensation expense in the December 31, 2006 Consolidated Statement
of Operations, however the shares will be considered issued on January 2,
2007.
On
August
3, 2006, the Company approved a grant of options to employees to purchase
at
$0.81 per share an aggregate of 480,000 shares of Company Common Stock which
vests in two installments, with 240,000 of the stock options vesting on the
date
that the Company files the New Drug Application (“NDA”) with the FDA for
Alprox-TD and 240,000 of the stock options vesting on the date that the NDA
is
accepted for review by the FDA. As a result of this grant, the Company recorded
$102,681 in compensation expense in the December 31, 2006 Consolidated Statement
of Operations.
On
January 13, 2006, the Board of Directors appointed Richard J. Berman to serve
as
President and Chief Executive Officer of the Company. In connection with
his
appointment, the Board of Directors approved a grant of options to Mr. Berman
to
purchase at $0.73 per share an aggregate of 990,000 shares of Company Common
Stock which vest in three installments, with 500,000 of the stock options
vesting on January 16, 2006, 245,000 of the stock options vesting on July
31,
2006, and 245,000 of the stock options vesting on January 31, 2007. As a
result
of this grant, the Company recorded $429,915 in compensation expense in the
December 31, 2006 Consolidated Statement of Operations.
On
March
7, 2006, the Company approved a grant of options to purchase at $1.05 per
share
an aggregate of 200,000 shares of the Company's Common Stock to Leonard A.
Oppenheim, as compensation for his service as the Lead Director on the Board
of
Directors. The stock options vest in two equal installments of 100,000 each,
with 50% of the stock options vesting immediately and 50% of the stock options
vesting on the date of the 2006 Annual Meeting of Stockholders , respectively,
assuming continuous and uninterrupted service as Lead Director on the Board
of
Directors. As a result of this grant, the Company recorded $156,482 in
compensation expense in the December 31, 2006 Consolidated Statement of
Operations.
On
April
28, 2006, the Company approved a grant of 388,571 shares of restricted stock
with a fair value of $310,857 to Richard J. Berman, President and CEO. The
restricted stock will vest and the restrictions will lapse only if the Company
completes a significant business development transaction with a minimum
valuation of $5 million and he remains President and CEO through the completion
of such transaction. Compensation expense resulting from this grant will
be
recorded when the Company completes a significant business development
transaction as stated above. These shares are considered contingent shares
and
will not be considered compensatory or outstanding until issued.
On
June
5, 2006, the Company approved a grant of options to purchase at $0.67 per
share
an aggregate of 200,000 shares of the Company's Common Stock to Leonard A.
Oppenheim, as compensation for his service as the Chairman of the Board of
Directors. The stock options vest in four equal installments of 50,000 each,
on
September 30, 2006, December 31, 2006, March 31, 2007, and the date of the
2007
Annual Meeting of Stockholders, assuming continuous and uninterrupted service
as
Chairman of the Board of Directors. As a result of this grant, the Company
recorded $57,870 in compensation expense in the December 31, 2006 Consolidated
Statement of Operations.
40
NexMed,
Inc.
Notes
to Consolidated Financial Statements
On
August
3, 2006, the Company approved a grant of options to purchase 60,000 shares
of
common stock at $0.81 to Arthur Emil as compensation for his services as
a
member of the Board of Directors. The stock options vest in three equal
installments on the date of the Annual Meeting of Stockholders in 2007, 2008
and
2009, respectively, assuming continuous and uninterrupted service with the
Company. As a result of this grant, the Company recorded $5,285 in compensation
expense in the December 31, 2006 Consolidated Statement of Operations.
10. |
Common
Stock
|
Pursuant
to a Common Stock and Warrant Purchase Agreement dated December 20, 2006,
the
Company closed a private placement of its securities and raised over $8.65
million in gross proceeds. The Company sold 13,317,000 shares of its common
stock at $0.6501 per share. The investors also received four-year warrants
to
purchase 5,326,800 shares of common stock, exercisable beginning six months
after closing at a price of $0.79 per share. The warrants would be redeemable
by
the Company at $0.01 per share if the closing sales price of its common stock
is
above $5 for ten consecutive trading days as reported on the Nasdaq Capital
Market or other principal exchange.
On
January 23, 2006, the Company closed a private placement of its securities
and
raised over $8.3 million in gross proceeds. The Company sold 9,347,191 shares
of
its common stock at $0.89 per share. The investors also received four-year
warrants to purchase 3,738,876 shares of common stock, exercisable beginning
six
months after closing at a price of $1.11 per share. The warrants would be
redeemable by the Company at $0.01 per share if the closing sales price of
its
common stock is above $5 for ten consecutive trading days as reported on
the
Nasdaq Capital Market or other principal exchange.
11. |
Series
C 6% Cumulative Convertible Preferred
Stock
|
On
May
17, 2005, the Company sold an aggregate of 445 shares of its Series C 6%
cumulative convertible preferred stock (the “Series C Stock”) and raised gross
proceeds of $4,450,000 ($10,000 liquidation preference per share). Each
preferred share of the Series C Stock was initially convertible at the holder’s
option into approximately 7,353 shares of common stock (total of 3,272,059
shares). Each investor also received for each share of Series C Stock purchased,
4-year detachable warrants to purchase 2,672 shares of common stock (total
of
1,188,931 warrants) at an exercise price of $1.43 per share. The Series C
Stock
could be converted at any time, at the holder’s option, into shares of the
Company’s common stock at an initial conversion value of $1.36. The Company also
had the right to force conversion of the Series C Stock, under certain
circumstances, at the initial conversion value. Under the terms of the
certificate of designation of the Series C Stock, the Company agreed to redeem
at the liquidation preference per share or convert the Series C Stock on
a
quarterly basis, subject, in each case to reduction by previously converted
shares of Series C Stock, as follows: $2 million plus accrued dividends on
September 30, 2005, $1 million plus accrued dividends each on December 31,
2005
and March 31, 2006 and $450,000 plus accrued dividends on June 30, 2006.
As a
result of the conversions described below, no shares of the Series C Stock
remained outstanding as of December 31, 2006.
41
NexMed,
Inc.
Notes
to Consolidated Financial Statements
The
Company valued the warrants using the Black-Scholes pricing model. The Company
allocated a relative fair value of $799,844 to the warrants. The relative
fair
value of the warrants was allocated to additional paid in capital and treated
as
a discount to the Series C Stock that would not be amortized until such time
as
the redemption for cash became probable. Therefore, the Company
recorded a deemed dividend to the shareholders of the Series C Stock in
proportion to the amount redeemed at any time redemption for cash became
probable. Assumptions utilized in the Black-Scholes model to value the warrants
were: exercise price of $1.43 per share; fair value of the Company’s common
stock on the date of issuance of $1.33 per share; volatility of 80%; term
of 4
years and a risk-free interest rate of 3.97%.
The
allocated value of the Series C Stock contained a beneficial conversion feature
calculated based upon the difference between the effective conversion price
of
the proceeds allocated to the Series C Stock, and the fair market value of
the
common stock on the date of issuance. As a result, the Company recorded a
deemed
dividend to the shareholders of the Series C Stock of $636,241 on the issuance
date, representing the value of the beneficial conversion feature of the
Series
C Stock. As the Company had no retained earnings on the date of the deemed
dividend, the dividend was recorded as a reduction to additional paid in
capital.
The
Company also recorded a discount to the Series C Stock of $209,686 based
on a
contingent beneficial conversion feature which would arise because the Company
must adjust the conversion price to be equal to a 4.5% discount to the then
common stock price on each respective settlement date. The Company has amortized
this discount, which is treated as a deemed dividend, over the life of the
Series C Stock using the effective interest method. For years ended December
31,
2006 and 2005, the Company recorded a deemed dividend to the shareholders
of the
Series C Stock $12,796 and $196,890, respectively, based on the amortization
of
the beneficial conversion feature.
For
the
years ended December 31, 2006 and 2005 pursuant to the terms of the Series
C
Stock, the Company recorded dividends in the amount of $15,264 and $123,326,
respectively, as a dividend to preferred shareholders in the Consolidated
Statements of Operations.
During
2005, the Company converted 357.5 shares of the
Series C Stock and accrued dividends into 3,215,590 shares of its common
stock
with an aggregate value of $3,482,974. During the first half of 2006, the
Company converted 72 shares of Series C Stock and accrued dividends into
880,308
shares of common stock with a value of $715,388.
On
June
30, 2006, pursuant to the terms of the Series C Stock, the Company converted
the
remaining 15.5 preferred shares and accrued dividends through June 30, 2006
of
$159,612 at a price of $0.65 per share. Upon conversion, the Company issued
a
total of 244,113 shares of common stock. As of December 31, 2006, no shares
of
the Series C Stock remained outstanding.
The
Company incurred issuance costs associated with the preferred placement of
$230,031. The relative fair value of the issuance costs attributable to the
Series C Stock of $188,685 was accreted as a deemed dividend to the holders
of
the Series C Stock at such time conversion became probable. The relative
fair
value of the issuance costs attributable to the warrants of $41,346 has been
recorded as an offset to additional paid in capital. For the years ended
December 31, 2006 and 2005, the Company amortized $37,101 and $151,584,
respectively, of the issuance costs as a deemed dividend to the preferred
shareholders in the Consolidated Statements of Operations.
42
NexMed,
Inc.
Notes
to Consolidated Financial Statements
12. |
Stockholder
Rights Plan
|
On
April
3, 2000, the Company declared a dividend distribution of one preferred share
purchase right (the "Right") for each outstanding share of the Company's
common
stock to shareholders of record at the close of business on April 21, 2000.
One
Right will also be distributed for each share of Common Stock issued after
April
21, 2000, until the Distribution Date described in the next paragraph. Each
Right entitles the registered holder to purchase from the Company a unit
consisting of one one-hundredths of a share (a "Unit") of Series A Junior
Participating Preferred Stock, $.001 par value per share (the "Preferred
Stock"), at a Purchase Price of $100.00 per Unit, subject to adjustment.
1,000,000 shares of the Company’s preferred stock have been set-aside for the
Rights Plan.
Initially,
the Rights will be attached to all Common Stock certificates representing
shares
then outstanding, and no separate Rights Certificates will be distributed.
The
Rights will separate from the Common Stock and a Distribution Date will occur
upon the earlier of (i) ten (10) business days following a public announcement
that a person or group of affiliated or associated persons (an "Acquiring
Person") has acquired, or obtained the right to acquire, beneficial ownership
of
15% or more of the outstanding shares of Common Stock (the "Stock Acquisition
Date"), or (ii) ten (10) business days following the public announcement
of a
tender offer or exchange offer that would, if consummated, result in a person
or
group beneficially owning 15% or more of such outstanding shares of Common
Stock, subject to certain limitations.
Under
the
terms of the Rights Agreement, Dr. Y. Joseph Mo, former CEO,, will be permitted
to increase his ownership to up to 25% of the outstanding shares of Common
Stock, without becoming an Acquiring Person and triggering a Distribution
Date.
On
January 16, 2007 the Rights Agreement was amended to exempt Southpoint Master
Fund, LP and its affiliates (collectively, “Southpoint”) from becoming an
“Acquiring Person” within the meaning of the Rights Agreement, provided that
Southpoint’s aggregate beneficial ownership of the Company’s common stock is
less than 20% of the shares of common stock then outstanding.
13. |
Warrants
|
A
summary
of warrant activity is as follows:
Common
|
|
Weighted
|
|
Weighted
|
|
|||||
|
|
Shares
|
|
Average
|
|
Average
|
|
|||
|
|
Issuable
upon
|
|
Exercise
|
|
Contractual
|
|
|||
|
|
Exercise
|
|
Price
|
|
Life
|
||||
Outstanding
at January 1, 2004
|
7,272,261
|
$
|
2.32
|
|||||||
Issued
|
5,128,496
|
1.86
|
||||||||
Redeemed
|
(7,500
|
)
|
1.94
|
|||||||
Cancelled
|
(956,566
|
)
|
3.67
|
|||||||
Outstanding
at December 31, 2004
|
11,436,691
|
1.91
|
||||||||
Issued
(Note 11)
|
1,188,938
|
1.43
|
||||||||
Redeemed
|
(471,883
|
)
|
1.53
|
|||||||
Cancelled
|
(1,123,196
|
)
|
1.99
|
|||||||
Outstanding
at December 31, 2005
|
11,030,550
|
1.83
|
||||||||
Issued
(Note 7 and 10)
|
9,565,676
|
0.90
|
||||||||
Redeemed
|
-
|
-
|
||||||||
Cancelled
|
(564,532
|
)
|
1.82
|
|||||||
Outstanding
at December 31, 2006
|
20,031,694
|
$
|
1.33
|
2.49
yrs
|
||||||
Exercisable
at December 31, 2006
|
14,704,894
|
$
|
1.53
|
1.96
yrs
|
43
NexMed,
Inc.
Notes
to Consolidated Financial Statements
14. |
Income
Taxes
|
The
Company has incurred losses since inception, which have generated net operating
loss carryforwards of approximately $84 million for federal and state income
tax
purposes. These carryforwards are available to offset future taxable income
and
expire beginning in 2014 through 2026 for federal income tax purposes. In
addition, the Company has general business and research and development tax
credit carryforwards of approximately $2.1 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 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. 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 additional equity financing obtained by the Company
since its formation.
In
2004,
2005 and 2006, the Company was approved by the State of New Jersey to sell
a
portion of its state tax credits pursuant to the Technology Tax Certificate
Transfer Program. The Company has approximately $3 million in NJ tax credits
left available to sell at December 31, 2006, and was approved to sell $637,525
in 2006, $540,580 in 2005, and $605,671 in 2004. The Company received net
proceeds of $567,397, $481,116, and $539,047 in 2006, 2005, and 2004,
respectively, as a result of the sale of the tax credits, which has been
recognized as received as an income tax benefit in the Consolidated
Statements of Operations. There can be no assurance that this program will
continue in future years.
The
net
operating loss carryforwards and tax credit carryforwards resulted in a
noncurrent deferred tax benefit at December 31, 2005 and 2004 of approximately
$32.8 million and $28.5 million, respectively. In consideration of the Company’s
accumulated losses and the uncertainty of its ability to utilize this deferred
tax benefit in the future, the Company has recorded a valuation allowance
of an
equal amount on such date to fully offset the deferred tax benefit
amount.
The
reconciliation of income taxes computed using the statutory U.S. income
tax rate
and the provision (benefit) for income taxes for the years ended December
31,
2006, 2005 and 2004 are as follows:
For
the years ended
|
|
|||||||||
|
|
December
31,
|
||||||||
2006
|
|
2005
|
|
2004
|
||||||
Federal
statutory tax rate
|
(35
|
%)
|
(35
|
%)
|
(35
|
%)
|
||||
State
taxes, net of federal benefit
|
(6
|
%)
|
(6
|
%)
|
(6
|
%)
|
||||
Valuation
allowance
|
41
|
%
|
41
|
%
|
41
|
%
|
||||
Sale
of state net operating losses
|
(7.11
|
%)
|
(3.12
|
%)
|
(3.16
|
%)
|
||||
Provision
(benefit) for income taxes
|
(7.11
|
%)
|
(3.12
|
%)
|
(3.16
|
%)
|
For
the
years ended December 31, 2006, 2005 and 2004, the Company’s effective tax rate
differs from the federal statutory rate principally due to net operating
losses
and other temporary differences for which no benefit was recorded, state
taxes
and other permanent differences.
44
NexMed,
Inc.
Notes
to Consolidated Financial Statements
15. |
Restructuring
|
On
December 15, 2005, the Company announced the departure of Dr. Y. Joseph Mo
as
President and Chief Executive Officer of the Company. On January 12, 2006,
we
announced the appointment of Richard J. Berman, who has served on the Board
of
Directors since 2002, as Chief Executive Officer of the Company. The Board
of
Directors mandated Mr. Berman to improve the Company’s financial condition and
focus its development efforts.
The
Company has incurred and expensed $239,572 and $176,071 in 2006 and 2005,
respectively, in connection with the reduction in staff related to this
restructuring. These costs are included in Research and development expenses
in
2006 and General and administrative expenses in 2005 in the Consolidated
Statement of Operations and Comprehensive Loss.
The
Company paid out $116,834 during the first quarter of 2006 that was accrued
in
2005 related to staff reductions in 2005. The remainder was paid out in 2005.
The majority of the 2006 restructuring costs were paid during 2006.
In
addition, the Company accrued and expensed $902,239 related to the departure
of
Dr. Mo and Kenneth Anderson in December 2005. These amounts were paid in
January
and February 2006.
16. |
Commitments
and Contingencies
|
The
Company is a party to clinical research agreements with commitments by the
Company initially totaling approximately $12.8 million. These agreements
were
amended in October 2005 such that the total commitment was reduced to
approximately $4.2 million. These agreements provide that if the Company
cancels
them prior to 50% completion, the Company will owe the higher of 10% of the
outstanding contract amount prior to the amendment or 10% of the outstanding
amount of the amended contract at the time of cancellation. At December 31,
2006, this amounts to approximately $1.1 million. The Company anticipates
that
the clinical research in connection with the agreements will be completed
in
2008.
The
Company is a party to several short-term consulting and research agreements
that, generally, can be cancelled at will by either party.
The
Company leased office space and research facilities under operating lease
agreements that expired in 2006. The Company also leased equipment from GE
Capital under capital leases that expired in 2006 (Note 8). Future minimum
payments under noncancellable operating leases with initial or remaining
terms
of one year or more, consist of the following at December 31, 2006:
We
are subject to certain legal proceedings in the
ordinary course of business. We do not expect any such items to have a
significant impact on our financial position.
45
NexMed,
Inc.
Notes
to Consolidated Financial Statements
Operating
|
||||
2007
|
19,848
|
|||
2008
|
11,578
|
|||
2009
|
-
|
|||
Total
minimum lease payments
|
$
|
31,426
|
Total
rent expense was $108,993, $485,256, and $484,053 in 2006, 2005, and 2004
respectively.
17. |
Segment
and Geographic Information
|
The
Company is active in one business segment: designing, developing, manufacturing
and marketing pharmaceutical products. The Company maintains development
and
business development
operations in the United States and
Hong
Kong.
Geographic
information as of December 31, 2006, 2005 and 2004 are as
follows:
For
the years ended December 31,
|
|
|||||||||
|
|
2006
|
|
2005
|
|
2004
|
||||
Net
revenues
|
||||||||||
United
States
|
$
|
758,207
|
$
|
1,062,550
|
$
|
216,891
|
||||
Hong
Kong
|
1,108,720
|
1,336,611
|
142,478
|
|||||||
$
|
1,866,927
|
$
|
2,399,161
|
$
|
359,369
|
December
31,
|
|||||||||||||
2006
|
|
2005
|
|
2004
|
|||||||||
Long-lived
assets
|
|||||||||||||
United
States
|
$
|
7,488,100
|
$
|
8,905,716
|
$
|
9,714,450
|
|||||||
Hong
Kong
|
-
|
-
|
-
|
||||||||||
$
|
7,488,100
|
$
|
8,905,716
|
$
|
9,714,450
|
46
47
ITEM
9. CHANGES
IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL
DISCLOSURE
On
November 14, 2006, the Board of Directors of the Company dismissed
PricewaterhouseCoopers LLP (“PwC”) as the Company’s independent registered
public accounting firm.
The
reports of PwC on the Company's consolidated financial statements as of
and for
the fiscal years ended December 31, 2004 and 2005 included an explanatory
paragraph regarding substantial doubt about the Company’s ability to continue as
a going concern. Other than as set forth above, such reports did not contain
any
adverse opinion or disclaimer of opinion, nor were such reports qualified
or
modified as to uncertainty, audit scope or accounting principle.
During
the fiscal years ended December 31, 2004 and 2005, and through November
14,
2006, the Company had no disagreements with PwC on any matter of accounting
principles or practices, financial statement disclosure, or auditing scope
or
procedure which would have caused PwC to make reference to the subject
matter of
the disagreement in connection with their reports on the financial statements
for such years.
During
the fiscal years ended December 31, 2004 and 2005, and through November
14,
2006, the Company had no reportable events under Item 304(a)(1)(v) of Regulation
S-K.
The
Company provided PwC with a copy of the foregoing disclosures. Attached
as
Exhibit 16.1 hereto to the Compnay's Form 8-K filed with the SEC on November
17,
2006 is a copy of the letter from PwC to the Securities and Exchange Commission,
dated November 17, 2006, stating that PwC agreed with such
statements.
On
November 29, 2006, the Company, with approval of the Audit Committee of
the
Board of Directors of the Company, engaged Amper, Politziner & Mattia P.C.
(“Amper Politziner”) as the Company's new independent registered public
accounting firm. During the fiscal years ended December 31, 2004 and 2005,
and
for the interim period through November 14, 2006, the date the engagement
of PwC
with the Company ended, neither the Company nor anyone acting on the Company's
behalf consulted Amper Politziner regarding either (i) the application
of
accounting principles to a specified transaction, either completed or proposed;
or the type of audit opinion that might be rendered on the Company's financial
statements, and neither a written report nor oral advice was provided by
Amper
Politziner to the Company that Amper Politziner concluded was an important
factor considered by the Company in reaching a decision as to any accounting,
auditing or financial reporting issues; or (ii) any matter that was either
the
subject of a "disagreement", as that term is described in Item 304(a)(1)(iv)
of
Regulation S-K promulgated by the Securities and Exchange Commission, and
the
related instructions to Item 304 of Regulation S-K, or a "reportable event",
as
the term is described in Item 304(a)(1)(v) of Regulation S-K.
ITEM
9A. CONTROLS
AND PROCEDURES
In
accordance with Exchange Act Rules 13a-15 and 15d-15, the Company’s management
carried out an evaluation with participation of the Company’s Chief Executive
Officer and Chief Financial Officer, its principal executive officer and
principal financial officer, respectively, of the effectiveness of the Company’s
disclosure controls and procedures as of the end of the period covered by this
report. Based upon that evaluation, the Chief Executive Officer and Chief
Financial Officer concluded as of the end of the period covered by this report
that the Company’s disclosure control and procedures are effective. There were
no changes in the Company’s internal controls over financial reporting
identified in connection with the evaluation by the Chief Executive Officer
and
Chief Financial Officer that occurred during the Company’s fourth quarter that
have materially affected or are reasonably likely to materially affect the
Company’s internal control over financial reporting.
48
ITEM
9B. OTHER
INFORMATION
None.
PART
III.
ITEM
10. DIRECTORS,
EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE.
Other
than as set forth below, information called for by Item 10 is set forth under
the heading “Election of Directors” and “Committees of the Board” in our 2007
Proxy Statement, which is incorporated herein by reference, and “Executive
Officers of the Registrant” of Part I of this Report.
The
Company has adopted a code of ethics that applies to its Chief Executive
Officer, Chief Financial Officer, and to all of its other officers, directors
and employees. The code of ethics is available at the Corporate Governance
section of the Investors page on the Company’s website at http://www.nexmed.com.
The
Company intends to disclose future amendments to, or waivers from, certain
provisions of its code of ethics, if any, on the above website within four
business days following the date of such amendment or waiver.
ITEM
11. EXECUTIVE
COMPENSATION.
Information
called for by Item 11 is set forth under the headings “Executive Compensation”
and “Directors Compensation” in our 2007 Proxy Statement, which is incorporated
herein by reference.
ITEM
12. SECURITY
OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER
MATTERS.
Other
than as set forth below, information called for by Item 12 is set forth under
the heading “Security Ownership of Certain Beneficial Owners and Management” in
our 2007 Proxy Statement, which is incorporated herein by
reference.
EQUITY
COMPENSATION PLAN INFORMATION
The
following table gives information as of December 31, 2006, about shares of
our
common stock that may be issued upon the exercise of options, warrants and
rights under all of our existing equity compensation plans (together, the
"Equity Plans"):
|
(a)
|
|
(b)
|
|
(c)
|
|||||
Plan
category
|
Number
of securities to be issued upon exercise of outstanding options,
warrants
and rights
|
|
Weighted-average
exercise price of outstanding options, warrants and rights
|
|
Number
of securities remaining available for future issuance under equity
compensation plans (excluding securities reflected in column (a))
|
|||||
Equity
compensation plans approved by security holders
|
3,613,421
|
(1)
|
$
|
1.52
|
1,833,368
|
(2)
|
||||
Equity
compensation plans not approved by security holders
|
||||||||||
Total
|
3,613,421
|
$
|
1.52
|
1,833,368
|
49
(1) |
Consists
of options outstanding at December 31, 2006 under The NexMed Inc.
Stock
Option and Long Term Incentive Plan (the "Incentive Plan") and The
NexMed,
Inc. 2006 Stock Incentive Plan (the "2006
Plan").
|
(2) |
Consists
of zero and 1,833,368 shares of common stock that remain available
for
future issuance, at December 31, 2006, under the Incentive Plan and
2006
Plan, respectively.
|
ITEM
13. CERTAIN
RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR
INDEPENDENCE.
Information
called for by Item 13 is set forth under the headings “Transactions with Related
Persons, Promoters and Certain Control Persons” and “Corporate Governance” in
our 2007 Proxy Statement, which is incorporated herein by
reference.
ITEM
14. PRINCIPAL ACCOUNTANT FEES AND SERVICES.
Information
called for by item 14 is set forth under the heading “Principal Accountant Fees
and Services” in our 2007 Proxy Statement, which is incorporated herein by
reference.
PART
IV.
ITEM
15. EXHIBITS,
FINANCIAL STATEMENT SCHEDULES
(a) |
1.
Financial
Statements:
|
The
information required by this item is included in Item 8 of Part II of this
Form
10-K.
2. |
Financial
Statement Schedules
|
Report
of
Independent Registered Public Accounting Firm on Financial Statement Schedule
for the year ended December 31, 2006.
Report
of
Independent Registered Public Accounting Firm on Financial Statement Schedule
for each of the two years in the period ended December 31, 2005
Schedule
II - Valuation and Qualifying Accounts.
50
SCHEDULE
II
NEXMED,
INC.
SCHEDULE
OF VALUATION AND QUALIFYING ACCOUNTS
Balance
at
|
Charged
to
|
Charged
|
||||||||||||||
Beginning
|
Costs
and
|
to
|
Balance
at
|
|||||||||||||
Description
|
of
Year
|
Expenses
|
Other
Accounts
|
Deductions
|
End
of Year
|
|||||||||||
Year
ended December 31, 2006
|
||||||||||||||||
Valuation
allowance - deferred tax asset
|
||||||||||||||||
$
|
32,859,672
|
$
|
3,682,438
|
—
|
—
|
$
|
35,642,110
|
|||||||||
Year
ended December 31, 2005
|
||||||||||||||||
Valuation
allowance - deferred tax asset
|
$
|
28,520,370
|
$
|
4,339,302
|
—
|
—
|
$
|
32,859,672
|
||||||||
Year
ended December 31, 2004
|
||||||||||||||||
Valuation
allowance - deferred tax asset
|
$
|
23,098,077
|
$
|
5,422,293
|
—
|
—
|
$
|
28,520,370
|
All
other
schedules have been omitted because the information is not applicable or is
presented in the Financial Statements or Notes thereto.
3. Exhibits
EXHIBITS
NO.
|
DESCRIPTION
|
|
3.1
|
Amended
and Restated Articles of Incorporation of the Company (incorporated
herein
by reference to Exhibit 2.1 filed with the Company's Form 10-SB filed
with
the Securities and Exchange Commission on March 14,
1997).
|
|
3.2
|
Amended
and Restated By-laws of the Company (incorporated herein by reference
to
Exhibit 3.1 to the Company’s Form 10-Q filed with the Securities and
Exchange Commission on May 14, 2003).
|
|
3.3
|
Certificate
of Amendment to Articles of Incorporation of the Company, dated June
22,
2000 (incorporated herein by reference to Exhibit 3.2 to the Company’s
Form 10-K filed with the Securities and Exchange Commission on March
31,
2003).
|
|
3.4
|
Certificate
of Amendment to the Company’s Articles of Incorporation, dated June 14,
2005. (incorporated herein by reference to Exhibit 3.4 to the Company’s
Form 10-K filed with the Securities and Exchange Commission on March
16,
2006)
|
|
3.5
|
Certificate
of Designation of the Company’s Series C 6% Cumulative Convertible
Preferred Stock (incorporated herein by reference to Exhibit 4.2
to the
Company’s Current Report on Form 8-K filed with the Securities and
Exchange Commission on May 19, 2005).
|
|
4.1
|
Form
of Common Stock Certificate (incorporated herein by reference to
Exhibit
3.1 filed with the Company's Form 10-SB filed with the Securities
and
Exchange Commission on March 14, 1997).
|
|
4.2
|
Rights
Agreement and form of Rights Certificate (incorporated herein by
reference
to Exhibit 4 to our Current Report on Form 8-K filed with the Commission
on April 10, 2000).
|
|
51
4.3
|
Certificate
of Designation of Series A Junior Participating Preferred Stock
(incorporated herein by reference to Exhibit 4 to our Current Report
on
Form 8-K filed with the Commission on April 10, 2000).
|
|
4.4
|
Certificate
of Designation of the Company's Series B 8% Cumulative Convertible
Preferred Stock (incorporated herein by reference to Exhibit 4.1
to the
Company’s Form 10-Q filed with the Securities and Exchange Commission on
May 14, 2003).
|
|
4.5
|
Form
of Warrant dated April 21, 2003 (incorporated herein by reference
to
Exhibit 4.2 to the Company’s Form 10-Q filed with the Securities and
Exchange Commission on May 14, 2003).
|
|
4.6
|
Form
of Common Stock Purchase Warrant dated July 2, 2003 (incorporated
herein
by reference to Exhibit 4.3 to the Company’s Registration Statement on
Form S-3 filed with the Securities and Exchange Commission on July
17,
2003).
|
|
4.7
|
Form
of Warrant dated June 18, 2004 (incorporated herein by reference
to
Exhibit 4.1 to the Company’s Form 8-K filed with the Securities and
Exchange Commission on June 25, 2004).
|
|
4.8
|
Form
of Common Stock Purchase Warrant A, dated December 17, 2004 (incorporated
herein by reference to Exhibit 4.1 to the Company’s Current Report on Form
8-K filed with the Securities and Exchange Commission on December
23,
2004).
|
|
4.9
|
Form
of Warrant, dated May 17, 2005 (incorporated herein by reference
to
Exhibit 4.1 to the Company’s Current Report on Form 8-K filed with the
Securities and Exchange Commission on May 19, 2005).
|
|
4.10
|
Form
of Warrant, dated January 23, 2006 (incorporated herein by reference
to
Exhibit 4.1 to the Company’s Current Report on Form 8-K filed with the
Securities and Exchange Commission on January 27,
2006).
|
|
4.11
|
Form
of Warrant, dated November 30, 2006 (incorporated herein by reference
to
Exhibit 4.1 to the Company’s Form 8-K filed with the Securities and
Exchange Commission on December 4, 2006).
|
|
4.12
|
Form
of Warrant, dated December 20, 2006 (incorporated herein by reference
to
Exhibit 4.1 to the Company’s Form 8-K filed with the Securities and
Exchange Commission on December 21, 2006).
|
|
4.13
|
Amendment
No. 1 to Rights Agreement, dated as of January 16, 2007 (incorporated
herein by reference to Exhibit 4.1 to the Company’s Form 8-K filed with
the Securities and Exchange Commission on January 22,
2007).
|
|
10.1*
|
Amended
and Restated NexMed, Inc. Stock Option and Long-Term Incentive
Compensation Plan (incorporated herein by reference to Exhibit 10.1
filed
with the Company's Form 10-Q filed with the Securities and Exchange
Commission on May 15, 2001).
|
|
10.2*
|
The
NexMed, Inc. Recognition and Retention Stock Incentive Plan (incorporated
herein by reference to Exhibit 99.1 filed with the Company's Form
8-K
filed with the Securities and Exchange Commission on May 28,
2004).
|
|
10.3*
|
Form
of Agreement dated November 15, 1995 between NexMed, Inc. and each
of Y.
Joseph Mo, Ph.D., Vivian H. Liu and Gilbert S. Banker, Ph.D, which
are
collectively commonly referred to by NexMed, Inc. as the Non-Qualified
Performance Incentive Program (filed as Exhibit 4.2 to the Company’s
Registration Statement on Form 8-A filed with the Securities and
Exchange
Commission on December 22, 1999, including any amendment or report
filed
for the purpose of updating such information, and incorporated herein
by
reference).
|
|
52
10.4
|
License
Agreement dated March 22, 1999 between NexMed International Limited
and
Vergemont International Limited (incorporated herein by reference
to
Exhibit 10.7 of the Company’s Form 10-KSB filed with the Securities and
Exchange Commission on March 16, 2000).
|
|
10.5*
|
The
NexMed, Inc. Non-Qualified Stock Option Plan (incorporated herein
by
reference to Exhibit 6.6 filed with the Company's Form 10-SB/A filed
with
the Securities and Exchange Commission on June 5,
1997).
|
|
10.6*
|
Employment
Agreement dated February 26, 2002 by and between NexMed, Inc. and
Dr. Y.
Joseph Mo (incorporated herein by reference to Exhibit 10.7 of the
Company's Form 10-K filed with the Securities and Exchange Commission
on
March 29, 2002).
|
|
10.7
|
Registration
Rights Agreement between the Company and The Tailwind Fund Ltd. and
Solomon Strategic Holdings, Inc. dated June 11, 2002 (incorporated
herein
by reference to Exhibit 10.2 to the Company's Form 10-Q filed with
the
Securities and Exchange
Commission on August 14, 2002).
|
|
10.8
|
Mortgage,
Security Agreement and Assignment of Leases and Rents by NexMed (U.S.A.),
Inc., a wholly owned subsidiary of the Company, in favor of The Tailwind
Fund Ltd. and Solomon Strategic Holdings, Inc. dated June 11, 2002
(incorporated herein by reference to Exhibit 10.4 to the Company's
Form
10-Q filed with the Securities and Exchange Commission on August
14,
2002)
|
|
10.9
|
Investor
Rights Agreement, dated as of April 21, 2003, between the Company
and the
Purchasers identified on Schedule 1 to the Investor Rights Agreement
(incorporated herein by reference to Exhibit 10.2 to the Company’s Form
10-Q filed with the Securities and Exchange Commission on May 14,
2003).
|
|
10.10
|
Investor
Rights Agreement, dated as of July 2, 2003, between the Company and
the
Purchasers identified on Schedule 1 to the Investor Rights Agreement
(incorporated herein by reference to Exhibit 10.2 to the Company’s
Registration Statement on Form S-3 filed with the Securities and
Exchange
Commission on July 17, 2003).
|
|
10.11*
|
Amendment
dated September 26, 2003 to Employment Agreement by and between
Dr. Y. Joseph Mo and NexMed, Inc. dated February 26, 2002 (incorporated
herein by reference to Exhibit 10.4 to the Company's Form 10-Q filed
with
the Securities and Exchange Commission on November 12,
2003).
|
|
10.12
|
Registration
Rights Agreement, dated as of December 12, 2003, between the Company
and
the Purchasers named therein (incorporated herein by reference to
Exhibit
10.2 to the Company’s Registration Statement on Form S-3 filed with the
Securities and Exchange Commission on January 13, 2004).
|
|
10.13
|
Form
of 5% Convertible Note due May 31, 2007 (incorporated herein by reference
to Exhibit 10.3 to the Company’s Registration Statement on Form S-3 filed
with the Securities and Exchange Commission on January 13,
2004).
|
|
10.14
|
First
Amendment of Mortgage, Security Agreement and Assignment of Leases
and
Rents by NexMed (U.S.A.), Inc., in favor of The Tail Wind Fund Ltd.
and
Solomon Strategic Holdings, Inc., dated as of December 12, 2003
(incorporated herein by reference to Exhibit 10.4 to the Company’s
Registration Statement on Form S-3 filed with the Securities and
Exchange
Commission on January 13, 2004).
|
|
53
10.15
|
Subsidiary
Guaranty by NexMed (U.S.A.), Inc., a wholly owned subsidiary of the
Company, in favor of The Tailwind Fund Ltd. and Solomon Strategic
Holdings, Inc. dated December 12, 2003 (incorporated herein by reference
to Exhibit 10.28 to the Company’s Form 10-K filed with the Securities and
Exchange Commission on March 4, 2004).
|
|
10.16
|
Investor
Rights Agreement, dated as of June 18, 2004, between the Company
and the
Purchasers identified on Schedule 1 thereto (incorporated herein
by
reference to Exhibit 10.2 to the Company’s Form 8-K filed with the
Securities and Exchange Commission on June 25, 2004).
|
|
10.17*
|
Stock
Option Grant Agreement between the Company and Leonard A. Oppenheim
dated
November 1, 2004 (incorporated herein by reference to Exhibit 10.2
to the
Company’s Form 10-Q filed with the Securities and Exchange Commission on
November 9, 2004).
|
|
10.18*
|
Form
of Stock Option Grant Agreement between the Company and its Directors
(incorporated herein by reference to Exhibit 10.29 of the Company’s Form
10-K filed with the Securities and Exchange Commission on March 16,
2006).
|
|
10.19
|
Investor
Rights Agreement, dated as of December 17, 2004, between the Company
and
the Purchasers named therein (incorporated herein by reference to
Exhibit
10.2 to our Current Report on Form 8-K filed with the Securities
and
Exchange Commission on December 23, 2004).
|
|
10.20
|
Preferred
Stock and Warrant Purchase Agreement, dated as of May 16, 2005, between
the Company and the Purchasers named therein (incorporated herein
by
reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K
filed with the Securities and Exchange Commission on May 19,
2005).
|
|
10.21
|
Investor
Rights Agreement, dated as of May 16, 2005, between the Company and
the
Purchasers named therein (incorporated herein by reference to Exhibit
10.2
to the Company’s Current Report on Form 8-K filed with the Securities and
Exchange Commission on December 23, 2004).
|
|
10.22+
|
License
Agreement, dated September 13, 2005, between NexMed, Inc., NexMed
International Limited and Novartis International Pharmaceutical
Ltd.(incorporated herein by reference to Exhibit 99.1 to the Company’s
Current Report on Form 8-K filed with the Securities and Exchange
Commission on September 15, 2005).
|
|
10.23
|
Common
Stock and Warrant Purchase Agreement, dated as of January 23, 2006,
between the Company and the Purchasers named therein (incorporated
herein
by reference to Exhibit 10.1 to our Current Report on Form 8-K filed
with
the Securities and Exchange Commission on January 27,
2006).
|
|
10.24
|
Investor
Rights Agreement, dated as of January 23, 2006, between the Company
and
the Purchasers named therein( (incorporated herein by reference to
Exhibit
10.2 to our Current Report on Form 8-K filed with the Securities
and
Exchange Commission on January 27, 2006).
|
|
10.25*
|
Employment
Agreement dated December 21, 2005 by and between NexMed, Inc. and
Vivian
H. Liu (incorporated herein by reference to Exhibit 10.30 to the
Company’s
Form 10-K filed with the Securities and Exchange Commission on March
16,
2006).
|
|
10.26*
|
Employment
Agreement dated December 21, 2005 by and between NexMed, Inc. and
Mark
Westgate (incorporated herein by reference to Exhibit 10.31 to the
Company’s Form 10-K filed with the Securities and Exchange Commission on
March 16, 2006).
|
|
10.27
|
Common
Stock and Warrant Purchase Agreement, dated January 23, 2006 (incorporated
herein by reference to Exhibit 10.1 to the Company’s Form 8-K filed with
the Securities and Exchange Commission on January 27,
2006).
|
|
54
10.28*
|
NexMed,
Inc. 2006 Stock Incentive Plan (incorporated herein by reference
to Annex
A of the Company’s Definitive Proxy Statement filed with the Securities
and Exchange Commission on April 6, 2006).
|
|
10.29
|
Securities
Purchase Agreement, dated November 30, 2006, between NexMed, Inc.,
NexMed
(U.S.A.), Inc. and Metronome LPC 1, Inc. (incorporated herein by
reference
to Exhibit 10.1 to the Company’s Form 8-K filed with the Securities and
Exchange Commission on December 4, 2006).
|
|
10.30
|
Senior
Secured Note, dated November 30, 2006, in favor of Metronome LPC
1, Inc.
(incorporated herein by reference to Exhibit 10.2 to the Company’s Form
8-K filed with the Securities and Exchange Commission on December
4,
2006).
|
|
10.31
|
Common
Stock and Warrant Purchase Agreement, dated December 20, 2006
(incorporated herein by reference to Exhibit 10.1 to the Company’s Form
8-K filed with the Securities and Exchange Commission on December
21,
2006).
|
|
10.32
|
Registration
Rights Agreement, dated December 20, 2006 (incorporated herein by
reference to Exhibit 10.2 to the Company’s Form 8-K filed with the
Securities and Exchange Commission on December 21,
2006).
|
|
10.33
|
Amendment,
effective as of February 13, 2007, to License Agreement between Novartis
International Pharmaceutical Ltd., NexMed, Inc. and NexMed International
Limited, dated September 13, 2005 (incorporated herein by reference
to
Exhibit 99.1 of the Company’s Form 8-K filed with the Securities and
Exchange Commission on February 23, 2007).
|
|
21
|
Subsidiaries.
|
|
23.1
|
Consent
of PricewaterhouseCoopers LLP, independent registered public accounting
firm.
|
|
23.2
|
Consent
of Amper, Politziner & Mattia P.C., independent registered public
accounting firm.
|
|
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.
|
|
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.
|
·
*
Management compensatory plan or arrangement required to be filed as an
exhibit
pursuant to Item 15(c) of Form 10-K.
·
+
Portions of this exhibit have been omitted pursuant to a request for
confidential treatment with the Securities and Exchange Commission. Such
portions have been filed separately with the Securities and Exchange
Commission.
55
Pursuant
to the requirements of the Section 13 or 15(d) of the Securities Exchange Act
of
1934, the Registrant has duly caused this report to be signed on its behalf
by
the undersigned, thereunto duly authorized.
NEXMED, INC. | ||
|
|
|
Dated:
March 26, 2007
|
By: | /s/ Richard J. Berman |
Richard
J. Berman
President
and Chief Executive Officer
|
Pursuant
to the requirements of the Securities Exchange Act of 1934, this report has
been
signed below by the following persons on behalf of the registrant and in the
capacities and on the dates indicated.
SIGNATURE
|
TITLE
|
DATE
|
||
/s/
Richard J. Berman
|
Director,
President and Chief Executive Officer
|
March
26, 2007
|
||
RICHARD
J. BERMAN
|
||||
/s/
Mark Westgate
|
Vice
President, Chief Financial Officer and
|
March
26, 2007
|
||
MARK
WESTGATE
|
principal accounting officer | |||
/s/
Leonard A. Oppenheim
|
Chairman
of the Board of Directors
|
March
26, 2007
|
||
LEONARD
A. OPPENHEIM
|
||||
/s/
Arthur D. Emil
|
Director
|
March
26, 2007
|
||
ARTHUR
D. EMIL
|
||||
/s/
Sami A. Hashim
|
Director
|
March
26, 2007
|
||
SAMI
A. HASHIM
|
||||
/s/
David S. Tierney, M.D.
|
Director
|
March
26, 2007
|
||
DAVID S. TIERNEY | ||||
/s/
Martin Wade III
|
Director
|
March
26, 2007
|
||
MARTIN
WADE III
|
56