SEELOS THERAPEUTICS, INC. - Annual Report: 2007 (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, 2007
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. o
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer, or a smaller reporting company.
See
definitions of “large accelerated filer”, “accelerated filer” and “smaller
reporting company” in Rule 12b-2 of the Exchange Act (check one): Large
accelerated filer o Accelerated
filer x Non-accelerated
filer o (do
not
check if a smaller reporting company) Smaller reporting company o
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 10, 2008, 83,108,002 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, 2007, was approximately $150 million.
DOCUMENTS
INCORPORATED BY REFERENCE
Portions
of our Proxy Statement to be delivered to our stockholders in connection with
the Company’s 2008 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, 2007
ITEMS
IN FORM 10-K
Page
|
||
PART
I.
|
||
Item
1.
|
BUSINESS.
|
3
|
Item
1A.
|
RISK
FACTORS
|
7
|
Item
1B.
|
UNRESOLVED
STAFF COMMENTS
|
12
|
|
||
Item
2.
|
PROPERTIES.
|
12
|
|
||
Item
3.
|
LEGAL
PROCEEDINGS.
|
12
|
|
||
Item
4.
|
SUBMISSION
OF MATTERS TO A VOTE OF SECURITY HOLDERS.
|
13
|
|
||
PART
II.
|
||
|
||
Item
5.
|
MARKET
FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER
|
|
MATTERS
AND ISSUER PURCHASES OF EQUITY SECURITIES.
|
13
|
|
|
||
Item
6.
|
SELECTED
FINANCIAL DATA.
|
14
|
|
||
Item
7.
|
MANAGEMENT’S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND
|
|
RESULTS
OF OPERATIONS.
|
15
|
|
|
||
Item
7A
|
QUANTITATIVE
AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.
|
22
|
|
||
Item
8.
|
FINANCIAL
STATEMENTS AND SUPPLEMENTARY DATA
|
22
|
|
||
Item
9A.
|
CONTROLS
AND PROCEDURES
|
47
|
|
||
Item
9B.
|
OTHER
INFORMATION
|
48
|
|
||
PART
III.
|
|
|
|
||
Item
10.
|
DIRECTORS,
EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE.
|
48
|
Item
11.
|
EXECUTIVE
COMPENSATION.
|
48
|
|
||
Item
12.
|
SECURITY
OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED
STOCKHOLDER MATTERS.
|
48
|
|
||
Item
13.
|
CERTAIN
RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR
INDEPENDENCE.
|
49
|
Item
14.
|
PRINCIPAL
ACCOUNTING FEES AND SERVICES
|
49
|
|
||
PART
IV.
|
|
|
|
||
Item
15.
|
EXHIBITS,
FINANCIAL STATEMENT SCHEDULES
|
49
|
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 have applied the
NexACT®
technology to a variety of compatible drug compounds and delivery systems,
and,
on our own or through development partnerships, are in various stages of
developing new topical treatments for male and female sexual dysfunction, nail
fungus, psoriasis, and other dermatological conditions. We intend to continue
our efforts developing topical treatments based on the application of
NexACT®
technology to drugs: (1) previously approved by the FDA, (2) with proven
efficacy and safety profiles, (3) with patents expiring or expired and (4)
with
proven market track records and potential.
On
June
18, 2007, Vivian H. Liu was appointed as our Chief Executive Officer. Ms. Liu
succeeded Richard J. Berman, who was elected by the Board to serve as its
non-executive Chairman. Mr. Berman was our interim Chief Executive Officer
from
January 2006 through June 2007 and has served as a Director of NexMed since
2002. At the Annual Meeting of Stockholders on June 18, 2007, Ms. Liu was also
elected to serve on the Board of Directors for a three-year term. On
November 2, 2007, we announced the appointment of Mr. Hem Pandya to the position
of Vice President and Chief Operating Officer. In
addition, we
have
formed a Scientific Advisory Board headed by Dr. David Tierney, who also serves
as a Director on the Board of Directors. The focus of the Scientific Advisory
Board is to assist us in evaluating our current pipeline consisting of early
stage NexACT®
based
products
under development, and also assist us in identifying and evaluating new product
development opportunities going forward.
We
have
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
July
9, 2007, we announced
that Novartis had completed patient enrollment for 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 are enrolled in
the
two studies, which are taking place in the U.S., Europe, Canada and Iceland.
The
Phase 3 program is expected to be completed in mid-2008.
3
The
completion of patient enrollment in the ongoing Phase 3 clinical trials for
NM100060 has triggered a $3 million milestone payment from Novartis. Pursuant
to
the terms of the licensing agreement with Novartis, this payment was due on
February 4, 2008, or 7 months after last patient enrolled in the Phase 3
studies. However, the agreement also provides that clinical milestones paid
to
us by Novartis shall be reduced by 50% until we receive an approved patent
claim
on the NM100060 patent application which we filed with the U.S. patent office
in
November 2004. As such, we received $1.5 million from Novartis
on March 4, 2008. In January 2008, we received the first Office Action from
the U.S. Patent Office. Based on the Office Action received, we expect to
receive before the end of the year an approved patent claim which would trigger
an additional $2 million patent milestone due from Novartis, and cause Novartis
to release to us the balance of $1.5 million remaining from the $3 million
patient enrollment milestone. However, there is no certainty that we will
receive an approved patent claim for NM100060 this year or at all.
In
March
2007, Novartis commenced a comparator study in ten European countries. Over
900
patients with mild to moderate onychomycosis are participating in this
open-label study, which is designed to assess the safety and tolerability of
NM100060 (terbinafine 10% topical formulation) versus locerylR
(amorolfine) 5% nail lacquer, a topical treatment for onychomycosis that is
approved in Europe. The comparator study is expected to be completed during
the
second half of 2008 and the data will be included in the European regulatory
application.
The
most
advanced of our products under development is our topical alprostadil-based
cream treatment intended for patients with erectile dysfunction (“the ED
Product”), which was previously known as Alprox-TD®.
Our New
Drug Application (“NDA”) was filed and accepted for review by the FDA in
September and November 2007, respectively. As such, according to the
Prescription Drug User Fees Act (“PDUFA”), the FDA’s expected target action
dateregarding approval of our NDA is July 19, 2008, assuming the FDA does not
require any significant additional studies or information during the review
process.
On
November 1, 2007, we licensed the U.S. rights of our ED Product to Warner
Chilcott Company, Inc. (“Warner”). Warner paid us $500,000 upon signing and
agreed to pay us up to $12.5 million on the achievement of specific regulatory
milestones and will undertake the manufacturing investment and any other
investment for further product development that may be required for product
approval, including an estimated $2 million for improvements to our East Windsor
manufacturing facility in order for the facility to be ready for commercial
manufacturing. Additionally, Warner is responsible for the commercialization
of
our ED Product. However, should Warner determine that it does not wish to
continue the regulatory approval process for our ED Product then the licensing
agreement would terminate and all rights would revert back to us.
The
NDA
for our ED Product is based on a formulation that requires refrigeration for
stability. We have developed the prototype for a non-refrigerated ED Product.
We
estimate that $5 million will have to be invested in the scale-up (developing
the prototype to production level) of the room temperature version of the ED
Product. Pursuant to the Warner contract, Warner would fund the development
expenses for the room temperature ED Product if Warner and NexMed jointly decide
to switch to the room temperature ED Product for commercialization.
We
have
taken the position that the safety data of the product, which is based on our
clinical database of over 3,000 patients, should be sufficient for filing for
marketing approval in the U.S., Canada and Europe 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.
In
terms
of the NDA filing in the U.S., there has been no discussion with the FDA
concerning our regulatory position that the 3,000 patient clinical data base
is
sufficient to be accepted in lieu of the ICH guidance for the 12 month
open-label study. As such, we will learn whether the FDA agrees with our
position as they are reviewing our NDA. We currently estimate the cost to
complete a 12 month open-label study to be approximately $8 million. Warner
will
undertake the investment necessary to complete the 12 month open-label study
should it be required by the FDA. Should Warner determine that it does not
wish
to seek further regulatory approval of our ED Product then the licensing
agreement would terminate and all rights would revert back to the Company.
There
is always the risk that we will not be successful in convincing the FDA to
approve the product for marketing.
4
In
January 2008, the FDA began and completed the pre-approval inspection (“PAI”) of
our facility which is a requirement upon the filing of the NDA for our ED
Product. The PAI is conducted by the FDA to ensure that our facility is in
compliance with Good Manufacturing Practices (“GMP”) as defined by FDA
regulations and to determine if we have the ability to begin commercial
manufacturing upon approval of the NDA. The PAI was completed with certain
observations made by the FDA and a withhold was placed on the facility,
which means that the facility is currently not approved by the FDA for
commercial manufacturing. The withhold status does not prevent the FDA from
reviewing other components of the NDA for approval of our ED Product. We are
currently working with the FDA to assess and respond to their observations
in a
timely manner in order to ensure that our facility is compliant with GMP well
in
advance of commercial manufacturing. While Warner intends to manufacture our
ED
Product in the future, our facility is listed as the manufacturing and quality
control laboratory in the NDA and will likely be the initial site for commercial
manufacturing of our ED Product upon its approval for commercialization.
On
February 21, 2007, the Canadian regulatory authority, Health Canada, informed
us
that the lack of a completed 12-month open label safety study would not preclude
them from accepting and reviewing our New Drug Submission (“NDS”) in Canada
which we filed on October 19, 2007. The review and approval process in Canada
typically takes about 12 months. Even though we are encouraged by the initial
positive feedback from Health Canada, the risk remains that we may not be
successful in convincing them to approve our product for marketing.
On
April
20, 2007, the United Kingdom regulatory authority, Medicines and Healthcare
Products Regulatory Agency (the “MHRA”) also informed us that the safety data
that we have compiled to date was sufficient for the Marketing Authorization
Application (“MAA”) to be filed and accepted for review in the United Kingdom.
We had another guidance meeting with the MHRA in January 2008 and received
additional input for the preparation of our MAA. However, the MHRA informed
us
at that time that due to the backlog of MAA filings, they would not be able
to
receive and start reviewing our MAA until February 2009. As a result of the
MHRA’s backlog, we are evaluating the opportunity to use another reference state
for our filing under the mutual recognition system to accelerate the filing
in
Europe. Even though we are encouraged by the initial positive feedback from
the
MHRA, the risk remains that we may not be successful in convincing the MHRA
and
other European regulatory authorities to approve our product for marketing.
We
are
also developing Femprox®,
which
is an alprostadil-based cream product intended for the treatment of female
sexual arousal disorder. We have completed nine clinical studies to-date,
including one 98-patient Phase 2 study in the U.S. for Femprox®,
and
also a 400-patient study for Femprox®
in
China, where the cost for conducting clinical studies is significantly lower
than in the U.S. We do not intend to conduct additional studies for this product
until we have secured a co-development partner, which we are actively
seeking.
We
have
also continued early stage development work for our product pipeline with the
goal of focusing our attention on product opportunities that would replicate
the
model of our licensed anti-fungal nail treatment. Our current efforts are
focused on the development of viable topical treatments for psoriasis, a common
dermatological condition.
Research
and Development
Our
research and development expenses for the years ended December 31 2007, 2006
and
2005 were $5,022,671, $5,425,137 and $11,222,099, respectively. Since January
1,
1994, when we repositioned ourselves as a medical and pharmaceutical technology
company, through December 31, 2007, we have spent $91,492,702 on research and
development.
Patents
We
have
thirteen 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.
5
The
following table identifies our thirteen 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
|
Prostaglandin
Composition and Methods of Treatment of Male Erectile
Dysfunction
|
2017
|
Medicament
Dispenser
|
2019
|
Crystalline
Salts of dodecyl 2-(N, N-Dimethylamino)-propionate *
|
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
|
*
Composition
of matter patent on our NexACT®
technology which is included in all of our current products under
development
The
two
patents covering the first generation of the NexACT®
technology enhancer will expire in 2008 and 2009. However, our current products
under development contain the second generation of the NexACT®
technology which is protected by a patent that will expire in 2019.
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 15 of the Notes to Consolidated Financial Statements in Item
8.
Employees
As
of
March 12, 2008, we had 24 full time employees, 3 of whom have a Ph.D degree,
3
of whom are executive management and 17 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
|
Vivian
H. Liu
|
46
|
Director,
President and Chief Executive Officer and Secretary
|
Hemanshu
Pandya
|
36
|
Vice
President and Chief Operating Officer
|
Mark
Westgate
|
38
|
Vice
President and Chief Financial Officer and
Treasurer
|
*As
of
March 1, 2008
6
Vivian
H.
Liu is, and has been, our President and Chief Executive Officer since June
2007
and Secretary since 1995, and also a Director of the Company since June 2007.
Ms. Liu served as the Company’s Executive Vice President and Chief Operating
Officer from January 2006 to June 2007, 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 B.A.
from the University of California, Berkeley.
Hemanshu
Pandya is, and has been, our Vice President and Chief Operating Officer since
October 2007. Mr. Pandya most recently served as Chief Commercial Officer for
Putney, Inc., a start-up veterinary pharmaceutical company from March 2007
to
July 2007. From August 2005 to December 2006, and prior to its merger with
Watson Pharmaceuticals, Inc., Mr. Pandya was Senior Vice President of Business
Development and Strategic Alliances for Andrx Pharmaceuticals, Inc., where
he
managed the licensing and co-development opportunities with strategic global
partners. From August 2002 to August 2005, Mr. Pandya served as Vice President
of Corporate Development and Commercial Operations for Able Laboratories, Inc.
Prior to August 2002, Mr. Pandya served in various senior management positions
with Ivax Pharmaceuticals, Inc. and Faulding/Purepac Pharmaceutical Company
(subsequently Alpharma, Inc.). He received his Bachelor’s Degree from Rutgers
University.
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 sixteen 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
will need additional funds to continue our operations through
2008.
7
Our
cash
reserves as of the date of this report are $3.6 million. We received a $1.5
million milestone payment from Novartis on March 4, 2008 pursuant to the terms
of the licensing agreement whereby the payment was due seven months after the
completion of patient enrollment for
the
Phase 3 clinical trials for NM100060, which occurred in July 2007. Although
the
completion of patient enrollment in the ongoing Phase 3 clinical trials for
NM100060 triggers a $3 million milestone payment from Novartis, the agreement
also provides that clinical milestones paid to us by Novartis shall be reduced
by 50% until we receive an approved patent claim on the NM100060 patent
application filed with the U.S. patent office in November 2004. Our cash
reserves provide us with sufficient cash to fund our operations only through
the
end of the second quarter of 2008 based on our projected 2008 overhead expenses
of approximately $500,000 per month and the anticipated expenditure of
approximately $1.2 million in direct expenses budgeted for our early stage
products under development and remaining costs related to the NDS in Canada
for
our ED Product. Upon receiving an approved claim on the NM100060 patent
application, we will receive the balance of $1.5 million due from the patient
enrollment milestone as well as a $2 million patent milestone from Novartis.
These additional milestones, which we expect to receive in 2008, provide
sufficient cash reserves to fund our operations through the end of the
year.
However,
there is no certainty that we will receive an approved patent claim for NM100060
this year or at all. Should we not receive an approved patent claim before
the
second quarter 2008, it will be necessary to obtain additional funding to
continue our operations in 2008.
On
March
5, 2008 we executed a non-binding term sheet with a potential buyer to close
a
sale-leaseback transaction on our East Windsor, New Jersey facility in
the second quarter at a purchase price of $7 million. The closing of this
transaction in the second quarter, along with our current cash reserves, would
provide sufficient funding for our operations through 2008. However, there
is no
assurance that we can agree on terms and close this transaction in the second
quarter of 2008 or at all.
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 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 $134,518,102 since our inception
and
through December 31, 2007. 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.
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, 2007 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, 2007, 2006
and 2005 were $5,022,671, $5,425,137 and $11,222,099, respectively. Since
January 1, 1994, when we repositioned ourselves as a medical and pharmaceutical
technology company, through December 31, 2007 we have spent $91,492,702 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.
8
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.
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 3 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.
We
depend on Warner Chilcott to realize the potential of our ED Product in the
United States.
In
November 2007, we announced a U.S. licensing agreement with Warner pursuant
to
which Warner acquired the exclusive U.S. rights to our ED Product, and agreed
to
pay us up to $12.5 million on the achievement of specific regulatory milestones
and assume all costs and responsibilities related to the development,
manufacturing and commercialization of our ED Product. In addition, Warner
agreed to pay us royalties based upon the level of sales achieved. In order
to
realize the full potential of our ED Product in the U.S., we will depend upon
Warner for the development, manufacturing and commercialization of our ED
Product. However, should Warner determine that it does not wish to continue
to
seek regulatory approval of our ED Product then the licensing agreement would
terminate and all rights would revert back to the Company.
9
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
thirteen 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 two patents
covering the first generation of the NexACT®
technology enhancer will expire in 2008 and 2009. However, our products under
development contain the second generation of the NexACT®
technology which is protected by a patent that will expire in 2019. While we
believe there are significant disadvantages to using the permeation enhancers
that are covered by the two patents expiring in 2008 and 2009, including the
difficulty of formulation, there is always a risk that once our enhancers are
off patent, they can be used by other parties to develop competitive products.
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.
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.
10
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 for marketed products as our products have yet
to be
commercialized. 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 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.
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.
11
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 10, 2008, 83,108,002 shares of our Common Stock
were issued and outstanding and 15,909,795 shares of our Common Stock were
issuable upon the exercise or conversion of outstanding options and warrants.
As
of March 10, 2008, 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.
|
We
currently have our principal executive offices, laboratories and pilot
manufacturing plant 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 subleased 1,000 square feet of office space in Hong Kong
for approximately $3,000 per month pursuant to a month-to-month arrangement.
In
September 2007, the Company ceased all operations in Hong Kong.
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.
12
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 2007.
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
10, 2008, the last reported sales price for our Common Stock on NASDAQ was
$1.45
per share, and we had 215 holders of record of our Common Stock.
The
following table sets forth the range of the high and low sales prices as
reported by NASDAQ for each quarter from January 1, 2006 to December 31,
2007.
Price
of Common Stock ($)
|
|||
High
|
Low
|
||
2007
|
|||
First
Quarter
|
1.54
|
0.72
|
|
Second
Quarter
|
2.05
|
1.24
|
|
Third
Quarter
|
1.90
|
1.47
|
|
Fourth
Quarter
|
1.71
|
1.34
|
|
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
|
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.
Performance
comparison of total return of NexMed, Inc., the
U.S. NASDAQ Stock market and NASDAQ Pharmaceuticals stocks
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, 2002 and quarterly reinvestment
of
dividends during the period).
13
*
$100
invested on 12/31/02 in stock or index-including reinvestment of
dividends.
Fiscal
year ending December 31.
|
12/02
|
12/03
|
12/04
|
12/05
|
12/06
|
12/07
|
|
|
|
|
|
|
|
|
|
NexMed,
Inc.
|
|
100.00
|
561.97
|
211.27
|
108.45
|
94.37
|
200.00
|
NASDAQ
Composite
|
|
100.00
|
149.34
|
161.86
|
166.64
|
186.18
|
205.48
|
NASDAQ
Pharmaceutical
|
|
100.00
|
144.23
|
159.47
|
159.95
|
162.76
|
152.73
|
Unregistered
sales of equity securities and use of proceeds
None.
ITEM 6. |
SELECTED
FINANCIAL DATA.
|
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.
14
Income
Statement Data
|
||||||||||||||||
2007
|
2006
|
2005
|
2004
|
2003
|
||||||||||||
Revenue
|
||||||||||||||||
Product
sales and royalties
|
$
|
4,036
|
$
|
7,243
|
$
|
9,702
|
$
|
9,519
|
$
|
6,206
|
||||||
Licensing
and research and development fees
|
$
|
1,266,331
|
$
|
1,859,684
|
$
|
2,389,459
|
$
|
349,850
|
$
|
104,537
|
||||||
Total
Expenses, net
|
$
|
(10,057,595
|
)
|
$
|
(9,910,180
|
)
|
$
|
(17,841,599
|
)
|
$
|
(17,383,017
|
)
|
$
|
(17,344,309
|
)
|
|
Net
Loss
|
$
|
(8,787,228
|
)
|
$
|
(8,043,253
|
)
|
$
|
(15,442,438
|
)
|
$
|
(17,023,648
|
)
|
$
|
(17,233,566
|
)
|
|
Basic
and Diluted Loss per Share
|
$
|
(0.11
|
)
|
$
|
(0.12
|
)
|
$
|
(0.32
|
)
|
$
|
(0.39
|
)
|
$
|
(0.60
|
)
|
|
Weighted
Average Common Shares Outstanding Used for Basic and Diluted Loss
per
Share
|
82,015,909
|
66,145,807
|
52,528,345
|
43,603,546
|
33,649,774
|
Balance
Sheet Data
|
December
31,
|
|
December
31,
|
|
December
31,
|
|
December
31,
|
|
December
31,
|
|
||||||
|
|
2007
|
|
2006
|
|
2005
|
|
2004
|
|
2003
|
||||||
Total
Assets
|
$
|
10,672,706
|
$
|
19,933,634
|
$
|
13,331,943
|
$
|
20,272,661
|
$
|
23,133,679
|
||||||
Total
Long Term Liabilities
|
$
|
3,538,051
|
$
|
1,058,098
|
$
|
4,122,997
|
$
|
6,801,826
|
$
|
7,335,877
|
||||||
Stockholders’
Equity
|
$
|
4,804,757
|
$
|
11,504,475
|
$
|
640,354
|
$
|
11,401,285
|
$
|
12,723,408
|
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,
nail
fungus, psoriasis, and other dermatological conditions.
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, 2007, we had an accumulated deficit of
$134,518,102. 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.
15
On
October 26, 2007 we issued a note in a principal amount of $3 million (the
“2007
Note”). The 2007 Note is due June 30, 2009 and accretes interest at a rate of 8%
per annum as discussed in Note 7 of the consolidated financial statements in
Item 8. We used approximately $2.1 million of the 2007 Note proceeds to pay
in
full the principal amount of the $2 million note that was due on December 31,
2007, plus accrued interest as discussed in Note 6 of the consolidated financial
statements in Item 8. The approximately $900,000 remaining was added to our
current cash reserves along with the $500,000 up front payment received from
Warner as discussed in Note 3 of the consolidated financial statements.
Additionally, we received a $1.5 million milestone payment from Novartis on
March 4, 2008 pursuant to the terms of the licensing agreement whereby the
payment was due seven months after the completion of patient enrollment
for
the
Phase 3 clinical trials for NM100060, which occurred in July 2007. Although
the
completion of patient enrollment in the ongoing Phase 3 clinical trials for
NM100060 triggers a $3 million milestone payment from Novartis, the agreement
also provides that clinical milestones paid to us by Novartis shall be reduced
by 50% until we receive an approved patent claim on the NM100060 patent
application filed with the U.S. patent office in November 2004. Our
cash
reserves of $3.6 million as of the date of this report provides us with
sufficient cash reserves to fund our operations through the end of the second
quarter of 2008 based on our projected 2008 monthly overhead costs
of
approximately $500,000 and the anticipated expenditure of approximately $1.2
million in direct expenditures budgeted for our early stage products under
development and remaining costs related to the NDS in Canada for our ED Product.
Upon receiving an approved claim on the NM100060 patent application we will
receive the balance of $1.5 million due from the patient enrollment milestone
as
well as a $2 million patent milestone from Novartis. These additional
milestones, which we expect to receive in 2008, provide sufficient cash reserves
to fund our operations through the end of the year.
However,
there is no certainty that we will receive an approved patent claim for NM100060
this year or at all. Should we not receive an approved patent claim before
the
second quarter 2008, it will be necessary to obtain additional funding to
continue our operations in 2008.
On
March
5, 2008 we executed a non-binding term sheet with a potential buyer to close
a
sale-leaseback transaction on our East Windsor, New Jersey facility in
the second quarter at a purchase price of $7 million. The closing of this
transaction in the second quarter, along with our current cash reserves, would
provide sufficient funding for our operations through 2008. However, there
is no
assurance that we can agree on terms and close this transaction in the second
quarter of 2008 or at all.
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, 2007 we had cash and cash equivalents and short term investments
of
approximately $3.5 million as compared to $12.1 million at December 31, 2006.
Our net decrease in cash in 2007 is the result of our average fixed monthly
overhead costs of approximately $450,000 per month, direct costs of
approximately $1.5 million related to the preparation of the regulatory filings
for our ED Product, the repayment of the $3 million convertible notes and $2
million note payable as discussed in Notes 6 and 7 of the consolidated financial
statements in Item 8. The repayment of the notes was partially funded by the
$2.8 million in net proceeds received from the 2007 Note as discussed above
and
in Note 7 of the consolidated financial statements. Additionally, the $500,000
up-front payment received from Warner as discussed above and in Note 3 of the
consolidated financial statement partially offset our reduction in cash in
2007.
At
December 31, 2007 we had other receivable of $0 as compared to $183,700 at
December 31, 2006. The other receivable consists of amounts billed to Novartis
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 for
completion of preclinical studies that we had begun prior to the signing of
the
agreement. 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, we did not bill Novartis
for any preclinical reimbursement costs in the remainder of 2007 and will not
be
billing Novartis for such costs in any future periods.
At
December 31, 2007, we had $693,774 in payroll related liabilities as compared
to
$156,567 at December 31, 2006. The increase is attributable to the payment
of
2006 bonuses in 2006 whereas in 2007 our bonuses were accrued in 2007 but are
not being paid until the first quarter of 2008.
At
December 31, 2007 we had convertible notes of $0 as compared to $3,000,000
at
December 31, 2006. The notes were due and paid in cash on May 31, 2007.
Therefore, at December 31, 2007, there is no remaining balance due to the
holders of the convertible notes.
16
For
the
year ended December 31, 2007 we incurred loss on disposal of fixed assets
(included in general and administrative expenses in our consolidated statement
of operations) of $10,121 as compared to $473,312 in 2006. The loss on disposal
of fixed assets resulted from the consolidation of our operations in 2006 into
our East Windsor facility. In consolidating our facilities and reducing staff
in
2006 we determined that we had excess laboratory equipment. We wrote off
obsolete equipment and sold many pieces of equipment.
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.
|
|
Less
than
|
1-3
|
3-5
|
More
than
|
|||||||||||
Comtractual Obligations |
Total
|
1
year
|
years
|
years
|
5
years
|
|||||||||||
Long-term debt* | $ | 3,360,000 | $ | 240,000 | $ | 3,120,000 | $ | 0 | $ | 0 | ||||||
Purchase obligations** | 4,182,700 | 3,346,160 | 836,540 | 0 | 0 | |||||||||||
Other long- term liabilities*** | 1,428,700 | 109,900 | 329,700 | 329,700 | 659,400 | |||||||||||
$ | 8,971,400 | $ | 3,696,060 | $ | 4,286,240 | $ | 329,700 | $ | 659,400 |
* |
Long-term
debt consists of one note totaling $3 million plus all related
interest.
|
** |
Purchase obligations consist of a
clinical research agreement that can be cancelled at any time on
thirty days prior written notice.
The Penalty for our cancellation
of this
agreement totaling $4,182,700 is approximately $1.1 million if cancelled
prior to 50% completion or 10% of outstanding contract amount at
the time
of cancellation if cancelled after the study is 50%
complete.
|
*** |
Represents 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
$1,060,274.
|
The
following table summarizes our contractual obligations and the periods in which
payments are due as of December 31, 2007:
Off-Balance
Sheet Arrangements
We
do not
have any off-balance sheet arrangements.
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.
17
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 our ED Product 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.
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), and 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 are and will
be
deferred and recognized as revenue over the performance period of such license
agreement.
18
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, 2007 and 2006
Revenues.
We
recorded revenues of $1,270,367 during 2007 as compared to $1,866,927 during
2006. The
decrease in revenue in 2007 is primarily attributable to the method used to
recognize revenue from the $4 million up-front payment received in 2005 from
Novartis
under
the
licensing agreement for NM100060.
As
discussed in Note 3 to the Consolidated Financial Statements, the
Novartis agreement was amended in February 2007 such that beginning with the
first quarter of 2007 we are
recognizing the initial up-front payment and preclinical reimbursement revenue
from this agreement based on a straight-line basis over the 18 month period
ended June 30, 2008 rather than the cost-to-cost method over the 32-month period
estimated to complete the remaining preclinical studies for
NM100060.
Accordingly, the Company recognized significantly more revenue in the first
quarter of 2006 because the
high
costs to initiate the preclinical studies in 2005 and early 2006 resulted in
a
larger portion of revenue recognized under the cost-to-cost method in 2006.
This
decrease in revenue is partially offset by the $111,000 in revenue recognized
in
2007 attributable to the up-front payment received in November 2007 from Warner
as discussed in Note 3 of the Consolidated Financial Statements.
Research
and Development Expenses.
Our
research and development expenses decreased from $5,425,137 in 2006 to
$5,022,671 in 2007. Research and development expenses in 2007 included
approximately $2 million attributable to our ED Product and the balance
attributable to other NexACT®
technology based products and indirect overhead related to research and
development, as compared to approximately $940,000 for NM100060 and $997,000
for
our ED Product during
2006. The majority of our expenses in 2007 were related to the filing of the
NDA
and NDS for our ED Product in 2007. We no longer have research and development
expenses related to NM100060, as we are no longer obligated to complete the
remaining preclinical studies for NM100060. Novartis has taken over all
responsibilities related to the remaining preclinical studies whereas in 2006,
we incurred the preclinical study costs and were reimbursed by Novartis. In
2008, we anticipate minimal expenses related to the European regulatory filing
for our ED Product. A large portion of our 2008 research and development
expenses will be for the other NexACT®
technology based products under development.
General
and Administrative Expenses.
Our
general and administrative expenses have increased from $5,570,765 in 2006
to
$5,634,479 in 2007. The modest increase in 2007 is primarily due to New Jersey
State sales tax paid of approximately $257,000 as a result of a sales tax audit
covering the period from 2000 to 2007, approximately $175,000 in consulting
fees
for business development and market research activities related to identifying
potential commercial partners for our ED product and an increase of
approximately $300,000 in legal fees related to the
national filings of patent applications for our ED Product as well as legal
fees
in connection with a patent lawsuit in which we are the plaintiff suing for
patent infringement of our herpes treatment medical device. In 2006 we recorded
a loss on disposal of equipment of approximately $473,000 as a result of the
consolidation of our operations in that year.
19
Interest
Expense.
We
recognized $481,862 and $380,860 in interest expense in 2007 and 2006
respectively. The increase is primarily due to the $3 million mortgage note
executed in October 2007 as discussed in Note 7 of the Consolidated Financial
Statements whereby we began amortizing $51,255 of the note discount in 2007.
Additionally, as discussed in Note 7 of the Consolidated Financial Statements,
in 2007 we incurred ten months of interest expense on the $2 million Note that
was repaid in October 2007 as compared to only one month of interest in 2006.
Other
income. Other
income was $0 in 2007 as compared to $627,455 in 2006. The 2006 other income
consisted of a one-time payment received when Schering elected to terminate
the
supply and distribution agreement for our ED Product without cause. Pursuant
to
the agreement, Schering was obligated to pay a termination fee of 500,000 Euros
or $627,455.
Net
Loss.
The net
loss was $8,787,228 and $8,043,253 in 2007 and 2006, respectively. The increase
is primarily attributable to the decrease in revenues primarily
attributable to the method used to recognize revenue from the $4 million
up-front payment received in 2005 from Novartis
under
the
licensing agreement for NM100060.
As
discussed in Note 3 to the Consolidated Financial Statements, the
Novartis agreement was amended in February 2007 such that beginning with the
first quarter of 2007 we are
recognizing the initial up-front payment and preclinical reimbursement revenue
from this agreement based on a straight-line basis over the 18 month period
ended June 30, 2008 rather than the cost-to-cost method over the 32-month period
estimated to complete the remaining preclinical studies for
NM100060.
Accordingly, the Company recognized significantly more revenue in 2006 as the
preclinical studies were initiated because the
high
costs to initiate the preclinical studies in 2005 and early 2006 resulted in
a
larger portion of revenue recognized under the cost-to-cost method in 2006.
Net
Loss applicable to Common Stock. The
net
loss applicable to common stock was $8,787,228 or $0.11 per share as compared
to
$8,108,414 or $0.12 per share for 2006. The increase in net loss applicable
to
common stock is primarily attributable to the
decrease in revenue as discussed above.
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 received
from our Asian licensee on sales of Befar®
in Hong
Kong and China. 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 reimbursed
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.
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 $473,000 as
a
result of the consolidation of our operations into our East Windsor facility.
20
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 our ED Product
without cause. Pursuant to the agreement, Schering was obligated to pay 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 mostly due 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 9 of the
Consolidated Financial Statements.
Quarterly
Results
The
following table sets forth selected unaudited quarterly financial information
for the years ended December 31, 2007 and 2006. The operating results are not
necessarily indicative of results for any future period.
For
the Three Months Ended
March
31, 2007
|
June
30, 2007
|
September
30, 2007
|
December
31, 2007
|
||||||||||
Total
Revenues
|
$
|
286,959
|
$
|
283,417
|
$
|
296,390
|
$
|
403,601
|
|||||
Loss
from Operations
|
($2,023,819
|
)
|
($1,975,228
|
)
|
($2,007,823
|
)
|
($3,379,913
|
)
|
|||||
Net
Loss
|
($2,039,309
|
)
|
($1,991,021
|
)
|
($2,026,378
|
)
|
($2,730,520
|
)
|
|||||
Basic
& Diluted Loss Per
Share
|
$
|
(0.03
|
)
|
$
|
(0.02
|
)
|
$
|
(0.02
|
)
|
$
|
(0.03
|
)
|
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
|
)
|
21
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 and 2007
|
23
|
Report
of Independent Registered Public Accounting Firm 2005
|
24
|
Financial
Statements
|
25
|
Consolidated
Balance Sheets - December 31, 2007 and 2006
|
25
|
Consolidated
Statements of Operations and Comprehensive Loss for the years ended
December 31, 2007, 2006 and 2005
|
26
|
Consolidated
Statements of Changes in Stockholders' Equity for years ended December
31,
2007, 2006 and 2005
|
27
|
Consolidated
Statements of Cash Flows for the years ended December 31, 2007, 2006
and
2005
|
28
|
Notes
to the Consolidated Financial Statements
|
29
|
Schedule
II - Valuation of Qualifying Accounts
|
50
|
22
NexMed,
Inc.
Consolidated
Balance Sheets
REPORT
OF
INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To
the
Board of Directors
Stockholders
of NexMed, Inc
We
have
audited the accompany consolidated balance sheets of NexMed, Inc. and
subsidiaries as of December 31, 2007 and 2006, and the related consolidated
statements of operations, stockholders’ equity and cash flows for the years
ended December 31, 2007 and 2006. Our audits also include the financial
statement schedule included in Item 15. We also have audited NexMed, Inc.‘s
internal control over financial reporting as of December 31, 2007, based
on
criteria established in Internal
Control-Integrated Framework issued
by
the Committee of Sponsoring Organizations of the Treadway Commission (COSO).
NexMed, Inc.‘s management is responsible for these financial statements and
financial statement schedule, for maintaining effective internal control
over
financial reporting, and for its assessment of the effectiveness of internal
control over financial reporting, included in the accompanying Management’s
Report on Internal Control over Financial Reporting. Our responsibility
is to
express an opinion on these financial statements and financial statement
schedule and an opinion on the company’s internal control over financial
reporting based on our audits.
We
conducted our audits in accordance with the standards of the Public Company
Accounting Oversight Board (United States). Those standards require that
we plan
and perform the audits to obtain reasonable assurance about whether the
financial statements are free of material misstatement and whether effective
internal control over financial reporting was maintained in all material
respects. Our audits of the financial statements included examining, on
a test
basis, evidence supporting the amounts and disclosures in the financial
statements, assessing the accounting principles used and significant estimates
made my management, and evaluating the overall financial statement presentation.
Our audit of internal control over financial reporting included obtaining
an
understanding of internal control over financial reporting, assessing the
risk
that a material weakness exists, and testing and evaluating the design
and
operating effectiveness of internal control based on the assessed risk.
Our
audits also included performing such other procedures as we considered
necessary
in the circumstances. We believe that our audits provide a reasonable basis
for
our opinions.
A
company’s internal control over financial reporting is a process designed to
provide reasonable assurance regarding the reliability of financial reporting
and the preparation of financial statements for external purposes in accordance
with generally accepted accounting principles. A company’s internal control over
financial reporting includes those policies and procedures that (1) pertain
to
the maintenance of records that, in reasonable detail, accurately and fairly
reflect the transactions and dispositions of the assets of the company;
(2)
provide reasonable assurance that transactions are recorded as necessary
to
permit preparation of financial statements in accordance with generally
accepted
accounting principles, and that receipts and expenditures of the company
are
being made only in accordance with authorizations of management and directors
of
the company; and (3) provide reasonable assurance regarding prevention
or timely
detection of unauthorized acquisition, use, or disposition of the company’s
assets that could have a material effect on the financial
statements.
Because
of its inherent limitations, internal control over financial reporting
may not
prevent or detect misstatements. Also, projections of any evaluation of
effectiveness to future periods are subject to the risk that controls may
become
inadequate because of changes in conditions, or that the degree of compliance
with the policies or procedures may deteriorate.
In
our
opinion, the financial statements and financial statement schedule referred
to
above present fairly, in all material respects, the financial position
of
NexMed, Inc. and subsidiaries as of December 31, 2007 and 2006, and the
results
of its operations and its cash flows for the years ended December 31, 2007
and
2006 in conformity with accounting principles generally accepted in the
United
States of America. Also in our opinion, NexMed, Inc. and subsidiaries
maintained, in all material respects, effective internal control over financial
reporting as of December 31, 2007, based on criteria established in Internal
Control-Internal Framework
issued
by the Committee of Sponsoring Organizations of the Treadway Commission
(COSO).
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 13 to the consolidated financial statements, effective
January 1, 2007, the Company adopted the provisions of Financial Interpretation
(“FIN”) No. 48, Accounting for Uncertainty in Income Taxes-An Interpretation
of
Financial Accounting Standards No. 109. Also, as discussed in Note 2
to the
consolidated financial statements, effective January 1, 2006, the Company
changed its method of accounting for “stock-based
compensation”.
/s/
Amper, Politziner & Mattia, PC
March
10,
2008
Edison,
New Jersey
23
NexMed,
Inc.
Consolidated
Balance Sheets
Report
of Independent Registered Public Accounting Firm
To
the
Board of Directors and Stockholders of NexMed, Inc.:
In
our
opinion, the consolidated statement of operations and comprehensive loss,
stockholders' equity, and cash flows for the year ended December 31, 2005
present fairly, in all material respects, the results of operations
and cash
flows of NexMed, Inc. and its subsidiaries for the year 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
the year 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 audit. We conducted our audit 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
audit provides a reasonable basis for our opinion.
PricewaterhouseCoopers
LLP
New
York,
New York
March
15,
2006
The
accompanying notes are an integral part of these consolidated financial
statements.
24
NexMed,
Inc.
Consolidated
Balance Sheets
December
31,
|
|||||||
Assets
|
2007
|
|
2006
|
||||
Current
assets
|
|||||||
Cash
and cash equivalents
|
$
|
2,735,940
|
$
|
11,069,133
|
|||
Short
term investments
|
750,000
|
1,000,000
|
|||||
Other
receivable
|
-
|
183,700
|
|||||
Debt
issuance cost, net of accumulated amortization of $7,565 and
$11,742
|
68,081
|
27,803
|
|||||
Prepaid
expenses and other current assets
|
127,659
|
164,898
|
|||||
Total
current assets
|
3,681,680
|
12,445,534
|
|||||
Fixed
assets, net
|
6,956,986
|
7,488,100
|
|||||
Debt
issuance cost, net of accumulated amortization of $3,782
|
34,040
|
-
|
|||||
Total
assets
|
$
|
10,672,706
|
$
|
19,933,634
|
|||
Liabilities
and Stockholders' Equity
|
|||||||
Current
liabilities
|
|||||||
Accounts
payable and accrued expenses
|
$
|
621,668
|
$
|
587,750
|
|||
Payroll
related liabilities
|
693,774
|
156,567
|
|||||
Deferred
revenue
|
953,528
|
1,693,917
|
|||||
Deferred
compensation - current portion
|
60,929
|
60,212
|
|||||
Note
payable, net of debt discount of $127,385
|
-
|
1,872,615
|
|||||
Convertible
notes payable - current portion
|
-
|
3,000,000
|
|||||
Total
current liabilities
|
2,329,899
|
7,371,061
|
|||||
Long
term liabilities
|
|||||||
Note
payable, net of debt discount of $461,295
|
2,538,705
|
-
|
|||||
Deferred
compensation
|
999,345
|
1,058,098
|
|||||
Total
liabilities
|
5,867,949
|
8,429,159
|
|||||
Commitments
and contingincies (Note 14)
|
|||||||
Stockholders'
equity:
|
|||||||
Common
stock, $.001 par value, 120,000,000 shares authorized,
|
|||||||
83,063,002
and 80,285,905 shares issued and outstanding, respectively
|
83,065
|
80,287
|
|||||
Additional
paid-in capital
|
139,239,794
|
137,164,658
|
|||||
Accumulated
other comprehensive loss
|
-
|
(9,596
|
)
|
||||
Accumulated
deficit
|
(134,518,102
|
)
|
(125,730,874
|
)
|
|||
Total
stockholders' equity
|
4,804,757
|
11,504,475
|
|||||
Total
liabilities and stockholders' equity
|
$
|
10,672,706
|
$
|
19,933,634
|
The
accompanying notes are an integral part of these consolidated financial
statements.
25
NexMed,
Inc.
Consolidated
Statements of Operations
For
the Year Ended
|
|
|||||||||
|
|
December
31,
|
|
|||||||
|
|
2007
|
|
2006
|
|
2005
|
||||
Revenues,
principally license fee revenue
|
1,270,367
|
1,866,927
|
2,399,161
|
|||||||
Costs
and expenses
|
||||||||||
Research
and development
|
5,022,671
|
5,425,137
|
11,222,099
|
|||||||
General
and administrative
|
5,634,479
|
5,570,765
|
6,878,335
|
|||||||
Total
costs and expenses
|
10,657,150
|
10,995,902
|
18,100,434
|
|||||||
Loss
from operations
|
(9,386,783
|
)
|
(9,128,975
|
)
|
(15,701,273
|
)
|
||||
Other
income (expense)
|
||||||||||
Other
income
|
-
|
627,455
|
-
|
|||||||
Interest
income
|
275,508
|
271,730
|
122,071
|
|||||||
Interest
expense
|
(481,862
|
)
|
(380,860
|
)
|
(344,352
|
)
|
||||
Total
other income (expense)
|
(206,354
|
)
|
518,325
|
(222,281
|
)
|
|||||
Loss
before benefit from income taxes
|
(9,593,137
|
)
|
(8,610,650
|
)
|
(15,923,554
|
)
|
||||
Benefit
from income taxes
|
805,909
|
567,397
|
481,116
|
|||||||
Net
loss
|
(8,787,228
|
)
|
(8,043,253
|
)
|
(15,442,438
|
)
|
||||
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
|
(8,787,228
|
)
|
(8,108,414
|
)
|
(16,550,479
|
)
|
||||
Other
comprehensive loss
|
||||||||||
Foreign
currency translation adjustments
|
-
|
-
|
592
|
|||||||
Comprehensive
loss
|
$
|
(8,787,228
|
)
|
$
|
(8,043,253
|
)
|
$
|
(15,441,846
|
)
|
|
Basic
and diluted loss per share
|
$
|
(.11
|
)
|
$
|
(.12
|
)
|
$
|
(.32
|
)
|
|
Weighted
average common shares outstanding
|
||||||||||
used
for basic and diluted loss per share
|
82,015,909
|
66,145,807
|
52,528,345
|
The
accompanying notes are an integral part of these consolidated financial
statements.
26
NexMed,
Inc.
Consolidated
Statements of Changes in Stockholders’ Equity
Foreign
|
|
||||||||||||||||||
|
Common
|
Common
|
Additional
|
|
Currency
|
Total
|
|||||||||||||
|
Stock
|
Stock
|
Paid-In
|
Accumulated
|
translation
|
Stockholders'
|
|||||||||||||
|
(Shares)
|
(Amount)
|
Capital
|
Deficit
|
|
Equity
|
|||||||||||||
Balance
at January 1, 2005
|
51,687,046
|
$
|
51,688
|
$
|
113,604,968
|
($102,245,183
|
)
|
($10,188
|
)
|
$
|
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
|
3,479,758
|
-
|
-
|
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
at 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
|
)
|
|||||||||||
80,285,905
|
$
|
80,287
|
$
|
137,164,658
|
($125,730,874
|
)
|
($9,596
|
)
|
$
|
11,504,475
|
|||||||||
Balance
at December 31, 2006
|
|||||||||||||||||||
Issuance
of common stock upon exercise of stock options and warrants,
net
|
1,717,943
|
1,718
|
219,175
|
-
|
-
|
220,893
|
|||||||||||||
Issuance
of compensatory options to employees and consultants
|
-
|
-
|
776,835
|
-
|
-
|
776,835
|
|||||||||||||
Issuance
of compensatory stock to employees and consultants
|
609,000
|
609
|
89,391
|
-
|
-
|
90,000
|
|||||||||||||
Issuance
of common stock in payment of interest on notes
|
145,614
|
146
|
190,602
|
-
|
-
|
190,748
|
|||||||||||||
Issuance
of compensatory stock to the board of directors
|
304,540
|
305
|
288,693
|
-
|
-
|
288,998
|
|||||||||||||
Net
offering costs from issuance of common stock
|
-
|
-
|
(2,110
|
)
|
-
|
-
|
(2,110
|
)
|
|||||||||||
Discount
on Note payable for issuance of warrants
|
-
|
-
|
512,550
|
-
|
-
|
512,550
|
|||||||||||||
Realized
gain on foreign currency exchange
|
9,596
|
9,596
|
|||||||||||||||||
Net
loss
|
-
|
-
|
-
|
(8,787,228
|
)
|
-
|
(8,787,228
|
)
|
|||||||||||
Balance
at December 31, 2007
|
83,063,002
|
$
|
83,065
|
$
|
139,239,794
|
($134,518,102
|
)
|
-
|
$
|
4,804,757
|
The
accompanying notes are an integral part of these consolidated financial
statements.
27
NexMed,
Inc.
Consolidated
Statements of Cash Flows
For
the Year Ended
|
||||||||||
December
31,
|
||||||||||
2007
|
|
2006
|
|
2005
|
||||||
Cash
flows from operating activities
|
||||||||||
Net
loss
|
$
|
(8,787,228
|
)
|
$
|
(8,043,253
|
)
|
$
|
(15,442,438
|
)
|
|
Adjustments
to reconcile net loss to net cash
|
||||||||||
used
in operating activities
|
||||||||||
Depreciation
and amortization
|
621,869
|
842,087
|
953,051
|
|||||||
Non-cash
interest, amortization of debt discount and
|
||||||||||
deferred
financing costs
|
408,538
|
328,050
|
315,512
|
|||||||
Non-cash
compensation expense
|
1,155,832
|
1,358,403
|
82,210
|
|||||||
Net
gain on foreign currency exchange
|
9,596
|
-
|
-
|
|||||||
Loss
on disposal of property and equipment
|
10,121
|
473,312
|
16,371
|
|||||||
Changes
in assets and liabilities
|
||||||||||
Decrease
(increase) in other receivable
|
183,700
|
(183,700
|
)
|
(582,440
|
)
|
|||||
Decrease
in prepaid expense and other assets
|
37,239
|
791,477
|
1,025,579
|
|||||||
(Decrease)
increase in deferred revenue
|
(740,389
|
)
|
(1,091,884
|
)
|
2,785,801
|
|||||
Increase
in payroll related liabilities
|
537,207
|
156,567
|
858,011
|
|||||||
(Decrease)
increase in deferred compensation
|
(58,036
|
)
|
(59,889
|
)
|
610,199
|
|||||
Increase
(decrease) in accounts payable and accrued expenses
|
33,918
|
(1,238,184
|
)
|
(457,577
|
)
|
|||||
Net
cash used in operating activities
|
(6,587,633
|
)
|
(6,667,014
|
)
|
(9,835,721
|
)
|
||||
Cash
flows from investing activities
|
||||||||||
Proceeds
from sale of fixed assets
|
-
|
178,769
|
-
|
|||||||
Capital
expenditures
|
(100,875
|
)
|
(76,553
|
)
|
(160,694
|
)
|
||||
Proceeds
from collection of note receivable
|
-
|
-
|
-
|
|||||||
Purchases
of short term investments
|
(3,000,000
|
)
|
(6,000,000
|
)
|
(1,500,000
|
)
|
||||
Proceeds
from sale of short term investments
|
3,250,000
|
5,500,000
|
2,384,000
|
|||||||
Net
cash provided by (used in) investing activities
|
149,125
|
(397,784
|
)
|
723,306
|
||||||
Cash
flows from financing activities
|
||||||||||
Issuance
of common stock, net of offering costs
|
(2,110
|
)
|
16,341,657
|
-
|
||||||
Proceeds
from exercise of stock options and warrants
|
220,893
|
97,316
|
834,426
|
|||||||
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
|
2,886,532
|
1,975,000
|
-
|
|||||||
Repayment
of notes payable
|
(2,000,000
|
)
|
||||||||
Repayment
of convertible notes payable
|
(3,000,000
|
)
|
(3,000,000
|
)
|
-
|
|||||
Principal
payments on capital lease obligations
|
-
|
(233,823
|
)
|
(644,049
|
)
|
|||||
Net
cash (used in) provided by financing activities
|
(1,894,685
|
)
|
15,180,150
|
4,318,319
|
||||||
Effect
of foreign exchange on cash
|
- |
-
|
592
|
|||||||
Net
increase (decrease) in cash and cash equivalents
|
(8,333,193
|
)
|
8,115,352
|
(4,793,504
|
)
|
|||||
Cash
and cash equivalents
|
||||||||||
Beginning
of year
|
11,069,133
|
2,953,781
|
7,747,285
|
|||||||
End
of year
|
$
|
2,735,940
|
$
|
11,069,133
|
$
|
2,953,781
|
||||
Cash
paid for interest
|
$
|
119,307
|
$
|
91,912
|
$
|
40,185
|
||||
Supplemental
disclosure of non-cash investing and financing activities:
|
||||||||||
Payment
of interest in common stock
|
190,748
|
304,167
|
304,166
|
|||||||
Amortization
of debt discount
|
178,640
|
10,615
|
-
|
|||||||
Conversion
of preferred stock to common stock
|
-
|
859,736
|
3,359,648
|
|||||||
Deemed
dividend to preferred shareholders
|
-
|
-
|
984,715
|
|||||||
Preferred
stock dividend paid in common stock
|
-
|
15,264
|
123,326
|
The
accompanying notes are an integral part of these consolidated financial
statements.
28
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 $134,518,102 at December 31, 2007 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.
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.
Short
term investments
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.
29
NexMed,
Inc.
Notes
to Consolidated Financial Statements
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 2007, 2006 or 2005.
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 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.
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) and 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.
30
NexMed,
Inc.
Notes
to Consolidated Financial Statements
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, 2007, 2006 and 2005, outstanding options to purchase 3,469,841,
3,663,421, and 5,018,880 shares of common stock, respectively, with exercise
prices ranging from $0.55 to $16.25 have been excluded from the computation
of
diluted loss per share as they are antidilutive. At December 31, 2007,
2006 and
2005, outstanding warrants to purchase 12,439,954, 20,125,027, and 11,030,550
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
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
9) 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.
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”, 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” 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.
31
NexMed,
Inc.
Notes
to Consolidated Financial Statements
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 Instruments 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 years ended December 31, 2007 and 2006 is $1,095,834 and $1,358,403
more,
respectively, 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” and its related interpretations. Basic and
diluted net loss per share for the years ended December 31, 2007 and 2006
of
$(0.11) and $(0.12), respectively, is $0.01 and $0.02 more than if the
Company
had not adopted SFAS 123R.
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 year ended December 31, 2005 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:
32
NexMed,
Inc.
Notes
to Consolidated Financial Statements
2005
|
||||
Net
loss applicable to common stock, as reported
|
$
|
(16,550,479
|
)
|
|
Add:
Stock-based compensation expense included
|
||||
in
reported net loss
|
82,210
|
|||
Deduct:
Total stock-based compensation expense determined
|
||||
under fair-value based method for all awards
|
(1,147,979
|
)
|
||
Proforma
net loss applicable to common stock
|
$
|
(17,616,248
|
)
|
|
Basic
and diluted loss per share:
|
||||
As
reported
|
$
|
(0.32
|
)
|
|
Proforma
|
$
|
(0.34
|
)
|
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, 2007
|
|
December
31, 2006
|
|||
Research
and development
|
111,108
|
122,800
|
|||||
General
and administrative
|
$
|
1,044,724
|
$
|
1,235,603
|
|||
Total
stock-based compensation expense
|
$
|
1,155,832
|
$
|
1,358,403
|
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, 2007 and 2006:
Dividend
yield
|
0.00%
|
Risk-free
yields
|
1.35%
- 5.02%
|
Expected
volatility
|
80%
- 103.51%
|
Expected
option life
|
1
-
6 years
|
Forfeiture
rate
|
6.41%
|
33
NexMed,
Inc.
Notes
to Consolidated Financial Statements
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 8.
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 No. 130, “Reporting Comprehensive Income” , 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 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.
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.
34
Recent
accounting pronouncements
In
February 2007, the FASB issued SFAS No. 159, "The Fair Value Option for
Financial Assets and Financial Liabilities" . FAS 159 permits companies
to
choose to measure certain financial instruments and certain other items
at fair
value. The standard requires that unrealized gains and losses on items
for which
the fair value option has been elected be reported in earnings. FAS 159
is
effective for us beginning in the first quarter of fiscal year 2009, although
earlier adoption is permitted. The Company is currently evaluating the
impact of
adopting FAS 159 on our consolidated financial statements.
In
December 2007, the FASB issued SFAS No. 141 (revised 2007), "Business
Combinations" , which replaces FASB Statement No. 141. FAS 141R establishes
principles and requirements for how an acquirer recognizes and measures
in its
financial statements the identifiable assets acquired, the liabilities
assumed,
any non controlling interest in the acquiree and the goodwill acquired.
The
Statement also establishes disclosure requirements which will enable users
to
evaluate the nature and financial effects of the business combination.
FAS 141R
is effective as of the beginning of an entity's fiscal year that begins
after
December 15, 2008. The Company is currently evaluating the potential impact,
if
any, of the adoption of FAS 141R on our consolidated financial position,
results
of operations and cash flows.
In
December 2007, the FASB issued SFAS No. 160, "Noncontrolling Interests
in
Consolidated Financial Statements - an amendment of Accounting Research
Bulletin
No. 51" ("FAS 160"), which establishes accounting and reporting standards
for
ownership interests in subsidiaries held by parties other than the parent,
the
amount of consolidated net income attributable to the parent and to the
noncontrolling interest, changes in a parent's ownership interest and the
valuation of retained noncontrolling equity investments when a subsidiary
is
deconsolidated. The Statement also establishes reporting requirements that
provide sufficient disclosures that clearly identify and distinguish between
the
interests of the parent and the interests of the noncontrolling owners.
FAS 160
is effective as of the beginning of an entity's fiscal year that begins
after
December 15, 2008. The Company is currently evaluating the potential impact,
if
any, of the adoption of FAS 160 on our consolidated financial position,
results
of operations and cash flows.
In
December 2007, the Emerging Issues Task Force (EITF) issued EITF Issue
No. 07-1,
“Accounting for Collaborative Arrangements.” EITF 07-1 provides guidance
concerning: determining whether an arrangement constitutes a collaborative
arrangement within the scope of the Issue; how costs incurred and revenue
generated on sales to third parties should be reported in the income statement;
how an entity should characterize payments on the income statement; and
what
participants should disclose in the notes to the financial statements about
a
collaborative arrangement. The provisions of EITF 07-1 will be adopted
in 2009.
The Company is in the process of evaluating the impact, if any, of adopting
EITF
07-1 on our financial statements.
3. |
Licensing
and Research and Development
Agreements
|
On
November 1, 2007, the Company signed an exclusive licensing agreement with
Warner Chilcott Company, Inc., (“Warner”) for its topical alprostadil-based
cream treatment for erectile dysfunction (“ED Product”). Under the agreement,
Warner acquired the exclusive rights in the United States to the ED Product
and
will assume all further development, manufacturing, and commercialization
responsibilities as well as costs. Warner agreed to pay the Company an
up front
payment of $500,000 and up to $12.5 million in milestone payments on the
achievement of specific regulatory milestones. In addition, the Company
is
eligible to receive royalties in the future based upon the level of sales
achieved by Warner, assuming the product is approved by the FDA.
35
NexMed,
Inc.
Notes
to Consolidated Financial Statements
The
Company is recognizing the initial up-front payment as revenue on a straight
line basis over the estimated 9 month period ending July 31, 2008 which
is the
remaining anticipated review time by the FDA for the Company’s new drug
application filed in September 2007 for the ED Product. Pursuant to the
agreement, NexMed is responsible for the regulatory approval of the ED
Product.
Accordingly, for the year ended December 31, 2007, the Company recognized
licensing revenue of $111,111 related to the Warner agreement.
On
September 15, 2005, the Company signed an exclusive global licensing agreement
with Novartis International Pharmaceutical Ltd., (“Novartis”) for its
anti-fungal product, NM100060. Under the agreement, Novartis acquired the
exclusive worldwide rights to NM100060 and would assume all further development,
regulatory, manufacturing and commercialization responsibilities as well
as
costs. Novartis agreed to pay the Company up to $51 million in upfront
and
milestone payments on the achievement of specific development and regulatory
milestones, including an initial cash payment of $4 million at signing.
In
addition, the Company is eligible to receive royalties based upon the level
of
sales achieved and is entitled to receive reimbursements of third party
preclinical study costs up to $3.25 million. The Company began recognizing
the
initial up front and preclinical reimbursement revenue from this agreement
based
on the cost-to-cost method over the 32-month period estimated to complete
the
remaining preclinical studies for NM100060. On February 16, 2007, the Novartis
agreement was amended. Pursuant to the amendment, the Company is no longer
obligated to complete the remaining preclinical studies for NM100060. Novartis
has taken over all responsibilities related to the remaining preclinical
studies. As such, the balance of deferred revenue of $1,693,917 at December
31,
2006 is being 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. Accordingly, for
the
year ended December 31, 2007, the Company recognized licensing revenue
of
$846,960 related to the Novartis agreement.
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.
4. |
Fixed
Assets
|
Fixed
assets at December 31, 2007 and 2006 were comprised of the
following:
36
NexMed,
Inc.
Notes
to Consolidated Financial Statements
2007
|
2006
|
||||||
Land
|
$
|
363,909
|
$
|
363,909
|
|||
Building
|
7,371,607
|
7,317,865
|
|||||
Machinery
and equipment
|
2,630,155
|
2,642,030
|
|||||
Computer
software
|
600,167
|
596,605
|
|||||
Furniture
and fixtures
|
188,935
|
196,027
|
|||||
11,154,773
|
11,116,436
|
||||||
Less:
accumulated depreciation
|
(4,197,787
|
)
|
(3,628,336
|
)
|
|||
$
|
6,956,986
|
$
|
7,488,100
|
Depreciation
and amortization expense was $621,870, $842,087, and $953,051 for 2007,
2006 and
2005 respectively, of which $0, $188,825, and $378,789 related to capital
leases
for the respective years.
5. |
Deferred
Compensation
|
On
February 27, 2002, the Company entered into an employment agreement with
Y.
Joseph Mo, Ph.D., that had a constant term of five years, and pursuant
to which
Dr. Mo 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 a vesting requirement
through
the date of termination, as set forth in the employment agreement. The
deferred
compensation is
payable
monthly for 180 months commencing on termination of employment. Dr. Mo’s
employment was terminated as of December 15, 2005. The monthly deferred
compensation payment through May 15, 2021 will be $9,158. As of December
31,
2007 and 2006, the Company has accrued $1,060,274 and $1,118,310 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 in an aggregate
principal amount of $6 million. The notes were payable in two installments
of $3
million on November 30, 2006 and May 31, 2007 and were collateralized by
the
Company’s facility in East Windsor, New Jersey which has a carrying value of
approximately $6.9 million. The notes were 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 accreted on the notes on a semi-annual basis
at a
rate of 5% per annum, and the Company could 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.
37
NexMed,
Inc.
Notes
to Consolidated Financial Statements
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
shares
of its common stock as payment of $304,167 in 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 of $25,417 on the note was paid on May 31, 2007 such that no amounts
remain outstanding at December 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. |
Notes
Payable
|
October
2007 Note
On
October 26, 2007 the Company issued a note in a principal amount of $3
million.
The note is payable on June 30, 2009 and can be prepaid by the Company
at any
time without penalty. Interest accretes on the note on a quarterly basis
at a
rate of 8.0% per annum. The note is collateralized by the Company’s facility in
East Windsor, New Jersey.
The
Company also issued to the noteholder a 5-year detachable warrant to purchase
450,000 shares of common stock at an exercise price of $1.52. Of the total
warrants issued, 350,000 warrants vest immediately and the remaining 100,000
warrants will vest if the note remains outstanding on October 26, 2008.
The
Company valued the warrants using the Black-Scholes pricing model. The
Company
allocated a relative fair value of $512,550 to the warrants. The relative
fair
value of the warrants is allocated to additional paid in capital and treated
as
a discount to the note that is being amortized over the 20-month period
ended
June 30, 2009.
For
the
year ended December 31, 2007, the Company recorded $51,255 of amortization
related to the note discount.
November
2006 Note
On
November 30, 2006, the Company issued a note in the principal amount of
$2
million. The note was 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 accreted on the note on a quarterly basis at a rate of
7.5% per
annum provided, however, if the Company had not entered into a contract
of sale
of the East Windsor property on or prior to May 31, 2007, and the note
had not
be repaid by such date, the interest rate would increase to 8.5%. As such,
on
May 31, 2007, the interest rate increased to 8.5%.
On
February 28, 2007, the Company issued 28,809 shares of its common stock
as
payment of an aggregate of $25,000 in interest on the note.
On
May 1,
2007, the Company issued 30,711 shares of its common stock as payment of
an
aggregate of $37,500 in interest on the note.
38
NexMed,
Inc.
Notes
to Consolidated Financial Statements
On
August
1, 2007 the Company issued 26,518 shares of its common stock as payment
of an
aggregate of $40,833 in interest on the note.
The
Company also issued the noteholder 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 was allocated to additional paid in capital and treated as
a
discount to the note that was being amortized through the October 2007
repayment
date.
This
note
was paid on October 29, 2007 with the proceeds from the issuance of the
$3
million note referred to above. The Company paid in cash the $2 million
balance
on the Note plus accrued interest of $42,028.
For
the
year ended December 31, 2007, the Company recorded $127,385 of amortization
related to the note discount.
8. |
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.
The
following table summarizes information about options outstanding at December
31,
2007:
39
NexMed,
Inc.
Notes
to Consolidated Financial Statements
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, 2005
|
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
|
(2,994,543
|
)
|
3.28
|
||||||||||
Outstanding
at December 31, 2006
|
3,663,421
|
$
|
1.52
|
||||||||||
Granted
|
202,100
|
1.41
|
|||||||||||
Exercised
|
(78,480
|
)
|
1.07
|
||||||||||
Cancelled
|
(317,200
|
)
|
2.82
|
||||||||||
Outstanding
at December 31, 2007
|
3,469,841
|
$
|
1.41
|
7.14
years
|
$
|
1,653,679
|
|||||||
Vested
or expected to vest at
|
|||||||||||||
December
31, 2007
|
3,247,424
|
$
|
1.41
|
7.14
years
|
$
|
1,578,078
|
|||||||
Exercisable
at December 31, 2007
|
3,122,740
|
$
|
1.43
|
6.93
years
|
$
|
1,578,078
|
|||||||
Exercisable
at December 31, 2006
|
2,395,897
|
$
|
1.83
|
||||||||||
Exercisable
at December 31, 2005
|
4,443,730
|
$
|
2.94
|
||||||||||
Options
available for grant at December 31, 2007
|
52,278
|
The
weighted average grant date fair value of options granted during 2007,
2006 and
2005 was $1.41, $0.78, and $1.03, respectively. The intrinsic value of
options
exercised during the year ended December 31, 2007 was $110,556.
As
of
December 31, 2007, there was $1,626,004 of total unrecognized compensation
cost
related to non-vested stock and stock options. That cost is expected to
be
recognized over a weighted-average period of 1.66 years.
Compensatory
Share Issuances
The
value
of restricted stock grants is calculated based upon the closing stock price
of
the Company’s common stock on the date of the grant. The value of the grant is
expensed over the vesting period of the grant in accordance with FAS123R
as
discussed in Note 2.
Principal
employee based compensation transactions for the year ended December 31,
2007
were as follows:
On
January 24, 2007, the Company issued awards of restricted shares of the
Company’s common stock to Richard Berman, Chief Executive Officer, Vivian Liu,
Chief Operating Officer, and Mark Westgate, Chief Financial Officer. Mr.
Berman’s award of 60,000 shares were to vest in four equal installments on March
31, June 30, September 30, and December 31, 2007, assuming continuous and
uninterrupted service as Chief Executive Officer of the Company. Mr. Berman’s
30,000 unvested shares at June 30, 2007 were cancelled upon his resignation
as
CEO and the appointment of Ms. Liu to the position of CEO. Ms. Liu and
Mr.
Westgate received awards of 150,000 and 75,000 restricted shares, respectively.
Ms. Liu and Mr. Westgate’s awards vest in three
equal installments on December 31, 2007, 2008 and 2009, assuming continuous
and
uninterrupted service with the Company.
40
NexMed,
Inc.
Notes
to Consolidated Financial Statements
Also
on
January 24, 2007, the Company issued awards of shares of the Company’s common
stock to Board members Leonard Oppenheim, Martin Wade and Arthur Emil for
their
services during their 2006 - 2007 terms. Mr. Oppenheim received an award
of
20,000 shares for his service as Chairman of the Board of Directors and
5,000
shares for his services as Chairman of the Finance Committee. Mr. Wade
received
an award of 10,000 shares for his service as Chairman of the Audit Committee
and
Compensation Committee of the Board of Directors. Mr. Emil received an
award of
5,000 shares for his service as Chairman of the Corporate Governance/Nominating
Committee of the Board of Directors. There
were no such shares issued in 2006 and 2005 for director services as chairman
of
Board Committees.
Additionally,
on April 1, June 28, September 28, and December 31, 2007 the Company issued
awards of shares of the Company’s common stock to each independent director as
compensation for his services during the quarters ended March 31, June
30, 2007,
September 30, 2007 and December 31, 2007. Each independent director received
10,227 shares of common stock for a total of 51,135 shares issued on each
April
1, June 28, and September 28, 2007 and December 31, 2007. In
2006,
the Company issued each independent director 12,329 shares of common stock
for a
total of 49,316 shares issued each calendar quarter for his services in
2006. In
2005 no such shares were issued as each of the directors was compensated
in cash
at $1,500 per month.
The
Company appointed Dr. David S. Tierney to the Board of Directors on January
24,
2007. In connection with his appointment to the Board, the Company issued
an
award of restricted shares of the Company’s common stock as compensation for his
services as a member of the Board of Directors. The restricted stock award
of
30,000 shares vests in three equal installments on February 1, 2007 and
on the
dates of the Annual Meeting of Stockholders in 2007 and 2008 assuming continuous
and uninterrupted service with the Company.
On
September 12, 2007, the Company issued awards of shares of the Company’s common
stock to Board members Leonard Oppenheim, Martin Wade, Arthur Emil and
David
Tierney for their services during their 2007 - 2008 terms. Mr. Oppenheim
received an award of 5,000 shares for his service as Chairman of the Finance
Committee of the Board of Directors. Mr. Wade received an award of 10,000
shares
for his service as Chairman of the Audit Committee and Compensation Committee
of
the Board of Directors. Mr. Emil received an award of 5,000 shares for
his
service as Chairman of the Corporate Governance/Nominating Committee of
the
Board of Directors. Dr. Tierney received an award of 20,000 shares for
his
service as Chairman of the Company’s Scientific Advisory Board.
On
October 3, 2007, the Company issued an award of 850,000 shares of the Company’s
common stock to Vivian Liu for her services as CEO. 100,000 shares vested
immediately while the remaining 750,000 shares will vest in three equal
installments of 250,000 shares on June 18, 2008, 2009 and 2010 assuming
continuous and uninterrupted service as CEO of the Company.
On
October 31, 2007, the Company hired Hemanshu Pandya as its Vice President
and
Chief Operating Officer. In connection with his employment agreement, Mr.
Pandya
was issued an award of 125,000 shares of the Company’s common stock. 75,000
shares will vest in three equal installments of 25,000 shares on October
31,
2008, 2009 and 2010 assuming continuous and uninterrupted service with
the
Company. 50,000 shares will vest upon the execution of a licensing/development
agreement brought to the Company by Mr. Pandya valued at over $5 million
on or
before April 30, 2009. Additionally, the Company awarded Mr. Pandya a grant
of
options to purchase at $1.43 per share an aggregate of 175,000 shares of
the
Company’s common stock. The stock options vest in three installments as follows:
25,000 on October 31, 2008, 50,000 shares on October 31, 2009 and 100,000
shares
on October 31, 2010 assuming continuous and uninterrupted service with
the
Company.
41
NexMed,
Inc.
Notes
to Consolidated Financial Statements
9.
|
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 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.
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.
For
the
years ended December 31, 2006 and 2005, the Company recorded a deemed dividend
of $49,897 and $984,715, respectively. This deemed dividend represents
the sum
of the beneficial conversion feature, amortization of the contingent beneficial
conversion feature, and amortization of preferred stock issuance
costs.
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
the Series C Stock and accrued dividends into 880,308 shares of its 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, 2007 and 2006,
no
shares of the Series C Stock remained outstanding.
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 will
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 will 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.
42
NexMed,
Inc.
Notes
to Consolidated Financial Statements
11. |
Stockholder
Rights Plan
|
On
April
3, 2000, the Company declared a dividend distribution of one preferred
share
purchase 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 , at a Purchase Price of $100.00 per Unit,
subject to adjustment. Under the Rights Plan, 1,000,000 shares of the Company’s
preferred stock have been set-aside.
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 , 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, the Company’s 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 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.
12. |
Warrants
|
A
summary
of warrant activity is as follows:
43
NexMed,
Inc.
Notes
to Consolidated Financial Statements
Weighted
|
Weighted
|
|
||||||||
|
|
Common
Shares
|
|
Average
|
|
Average
|
|
|||
|
|
Issuable
upon
|
|
Exercise
|
|
Contractual
|
|
|||
|
|
Exercise
|
|
Price
|
|
Life
|
||||
Outstanding
at January 1, 2005
|
11,436,691
|
1.91
|
||||||||
Issued
(Note 9)
|
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
(Notes 7 and 10)
|
9,565,676
|
0.90
|
||||||||
Redeemed
|
-
|
-
|
||||||||
Cancelled
|
(471,199
|
)
|
1.82
|
|||||||
Outstanding
at December 31, 2006
|
20,125,027
|
$
|
1.33
|
|||||||
Issued
(Note 7)
|
450,000
|
$
|
1.52
|
|||||||
Exercised
|
(2,790,495
|
)
|
$
|
1.83
|
||||||
Cancelled
|
(5,344,578
|
)
|
$
|
1.40
|
||||||
Outstanding
at December 31, 2007
|
12,439,954
|
$
|
1.23
|
2.43
years
|
||||||
Exercisable
at December 31, 2007
|
12,339,954
|
$
|
1.23
|
2.41
years
|
13. |
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
2005,
2006 and 2007, 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 $1.9 million in NJ tax
credit
benefits left available to sell at December 31, 2007, and was approved
to sell
net operating loss tax benefits of $905,515 in 2007, $637,525 in 2006,
and
$540,580 in 2005. The Company received net proceeds of $805,909, $567,397,
and
$481,116 in 2007, 2006, and 2005, 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, 2007, 2006 and 2005 of
approximately $39.2 million, $35.6 million and $32.8 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.
In
June
2006, the FASB issued FIN No. 48, Accounting for Uncertainty in Income
Taxes-an
interpretation of FASB Statement No. 109 (“FIN 48”) which clarifies the
accounting for uncertainty in income taxes recognized in an enterprise’s
financial statements in accordance with FASB Statement No. 109, Accounting
for
Income Taxes. FIN 48 prescribes a recognition threshold and measurement
criteria
for the financial statement recognition and measurement of a tax position
taken
or expected to be taken in a tax return. FIN No. 48 also provides guidance
on
derecognition, classification, interest and penalties, accounting in
interim
periods, disclosure, and transition and defines the criteria that must
be met
for the benefits of a tax position to be recognized. The cumulative effect
of
the change in accounting principle must be recorded as an adjustment
to opening
retained earnings. Effective January 1, 2007, the Company adopted FIN
No. 48 and
determined that such adoption did not have a material impact on its financial
statements.
44
NexMed,
Inc.
Notes
to Consolidated Financial Statements
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,
2007, 2006 and 2005 are as follows:
For
the years ended
|
||||||||||
December
31,
|
||||||||||
2007
|
|
2006
|
|
2005
|
||||||
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
|
(8.40%)
|
|
(6.59%)
|
|
(3.02%)
|
|
||||
Provision
(benefit) for income taxes
|
(8.40%)
|
|
(6.59%)
|
(3.02%)
|
|
For
the
years ended December 31, 2007, 2006 and 2005, 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.
14. |
Commitments
and Contingencies
|
The
Company is a party to clinical research agreements 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, 2007, 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.
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.
15. |
Segment
and Geographic Information
|
The
Company is active in one business segment: designing, developing, manufacturing
and marketing pharmaceutical products. The Company maintained development
and
business development
operations in the United States and
Hong
Kong in 2005, 2006. In September 2007, the Company ceased all operations
in Hong
Kong.
Geographic
information as of December 31, 2007, 2005 and 2005 are as follows:
45
NexMed,
Inc.
Notes
to Consolidated Financial Statements
|
|
For
the years ended December 31,
|
|
|||||||
|
|
2007
|
|
2006
|
|
2005
|
||||
Net
revenues
|
||||||||||
United
States
|
$
|
775,894
|
$
|
758,207
|
$
|
1,062,550
|
||||
Hong
Kong
|
494,473
|
1,108,720
|
1,336,611
|
|||||||
$
|
1,270,367
|
$
|
1,866,927
|
$
|
2,399,161
|
|||||
December
31,
|
|
|||||||||
|
|
2007
|
|
2006
|
|
2005
|
||||
Long-lived
assets
|
||||||||||
United
States
|
$
|
6,956,986
|
$
|
7,488,100
|
$
|
8,905,716
|
||||
Hong
Kong
|
-
|
-
|
-
|
|||||||
$
|
6,956,986
|
$
|
7,488,100
|
$
|
8,905,716
|
46
ITEM 9. |
CHANGES
IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL
DISCLOSURE
|
None.
|
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.
Management’s
Report on Internal Control over Financial Reporting
Our
Management is responsible for establishing and maintaining adequate internal
control over financial reporting, as such term is defined in Exchange Act Rule
13a-15(f). Under the supervision and with the participation of our management,
including our principal executive officer and principal financial officer,
we
conducted an evaluation of the effectiveness of our internal control over
financial reporting based on the framework in Internal
Control - Integrated Framework
issued
by the Committee of Sponsoring Organizations of the Treadway Commission. Based
on our evaluation under such framework, our management concluded that our
internal control over financial reporting was effective as of December 31,
2007.
47
The
effectiveness of our internal control over financial reporting as of December
31, 2007 has been audited by Amper, Politziner & Mattia, PC, an independent
registered public accounting firm, as stated in their report which is included
herein.
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 2008
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 2008 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 2008 Proxy Statement, which is incorporated herein by
reference.
EQUITY
COMPENSATION PLAN INFORMATION
The
following table gives information as of December 31, 2007, 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"):
48
(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
|
3,469,841
(1
|
)
|
$
|
1.41
|
52,278
(2
|
)
|
||||
Equity
compensation plans not approved by security holders
|
||||||||||
Total
|
3,469,841
|
$
|
1.41
|
52,278
|
(1)
Consists of options outstanding at December 31, 2007 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 52,278 shares of common stock that remain available for
future issuance, at December 31, 2007, 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 2008 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 2008 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
|
Schedule
II - Valuation of Qualifying Accounts
Report
of
Independent Registered Public Accounting Firm on Financial Statement Schedule
for the years ended December 31, 2007 and 2006 (contained
in Report of Independent Registered Public Accounting Firm 2006 and 2007
included in Item 8 of Part II of this Form 10-K).
Report
of
Independent Registered Public Accounting Firm on Financial Statement Schedule
for the year ended December 31, 2005 (contained
in Report of Independent Registered Public Accounting Firm 2005 included in
Item
8 of Part II of this Form 10-K).
49
SCHEDULE
II
NEXMED,
INC.
SCHEDULE
OF VALUATION AND QUALIFYING ACCOUNTS
Description
|
Balance
at
Beginning
of
Year
|
Charged
to
Costs
and
Expenses
|
Charged
to
Other
Accounts
|
Deductions
|
Balance
at
End
of Year
|
|||||||||||
Year
ended December 31, 2007
|
||||||||||||||||
Valuation
allowance - deferred tax asset
|
$
|
35,642,110
|
$
|
3,632,017
|
--
|
--
|
$
|
39,274,127
|
||||||||
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 |
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)
|
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).
|
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).
|
4.5
|
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).
|
50
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).
|
4.10
|
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).
|
4.11
|
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).
|
4.12
|
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).
|
4.14
|
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).
|
4.15
|
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).
|
4.16
|
Form
of Warrant, dated October 26, 2007 (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 October 31,
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
|
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).
|
10.4*
|
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).
|
10.5*
|
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).
|
10.6
|
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).
|
10.7
|
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).
|
51
10.8
|
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).
|
10.9*
|
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).
|
10.10
|
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).
|
10.11
|
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).
|
10.12
|
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).
|
10.13*
|
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).
|
10.14*
|
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).
|
10.15
|
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).
|
10.16
|
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).
|
10.17
|
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).
|
10.18+
|
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).
|
10.19
|
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).
|
10.20
|
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).
|
52
10.21*
|
Employment
Agreement dated December 21, 2005 by and between NexMed, Inc. and
Vivian
H. Liu.
|
10.22*
|
Employment
Agreement dated December 21, 2005 by and between NexMed, Inc. and
Mark
Westgate.
|
10.23
|
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).
|
10.24*
|
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).
|
10.25
|
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).
|
10.26
|
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).
|
10.27
|
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).
|
10.28
|
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).
|
10.29
|
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).
|
10.30*
|
Employment
Agreement dated October 31, 2007 between NexMed, Inc. and Hemanshu
Pandya
(incorporated herein by reference to Exhibit 10.1 of the Company’s
Form 8-K
filed with the Securities and Exchange Commission on November 5,
2007).
|
10.31+
|
License
Agreement dated November 1, 2007 between NexMed, Inc. and Warner
Chilcott
Company, Inc.
|
10.32
|
Securities
Purchase Agreement, dated October 26, 2007, between NexMed, Inc.
and Twin
Rivers Associates LLC (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 October 31, 2007).
|
10.33
|
Senior
Secured Note, dated October 26, 2007, between NexMed, Inc. and Twin
Rivers
Associates LLC (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 October 31, 2007).
|
10.34 | Registration Rights Agreement, dated October 26, 2007, between NexMed, Inc. and Twin Rivers Associates LLC (incorporated herein by reference to Exhibit 10.3 to the Company's Current Report on Form 8-K filed with the Securities and Exchange Commission on October 31, 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.
53
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 12, 2008
|
By: |
/s/
Vivian Liu
|
Vivian Liu |
||
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/
Vivian H. Liu
VIVIAN
H. LIU
|
Director,
President and Chief Executive Officer
|
March
12, 2008
|
/s/
Mark Westgate
MARK
WESTGATE
|
Vice
President, Chief Financial Officer and principal accounting
officer
|
March
12, 2008
|
/s/
Richard J. Berman
RICHARD
J. BERMAN
|
Chairman
of the Board of Directors
|
March
12, 2008
|
/s/
Arthur D. Emil
ARTHUR
D. EMIL
|
Director
|
March
12, 2008
|
/s/
Leonard A. Oppenheim
LEONARD
A. OPPENHEIM
|
Director
|
March
12 2008
|
/s/
David S. Tierney, M.D.
DAVID
S. TIERNEY
|
Director
|
March
12, 2008
|
/s/
Martin Wade III
MARTIN
WADE III
|
Director
|
March
12, 2008
|
54