Unassociated Document
UNITED
STATES SECURITIES AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-KSB
x |
Annual
Report pursuant to Section 13 or 15(d) of the Securities Exchange Act of
1934 for the fiscal year ended December 31,
2004 |
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 0-16686
VIOQUEST
PHARMACEUTICALS, INC.
(Exact
name of issuer as specified in its charter)
Minnesota
(State
or other jurisdiction of incorporation or organization)
|
58-1486040
(IRS
Employer Identification No.)
|
7
Deer Park Drive, Suite E, Monmouth Junction, NJ
(Address
of Principal Executive Offices)
|
08852
(Zip
Code) |
(732)
274-0399
(Issuer’s
telephone number)
Securities
registered pursuant to Section 12(b) of the Exchange Act:
None
Securities
registered pursuant to Section 12(g) of the Exchange
Act: |
|
Common
Stock, $.01 par value |
Check
whether the issuer: (1) filed all reports required to be filed by Section 13 or
15(d) of the Securities Exchange Act of 1934 during the past 12 months (or for
such shorter period that the issuer was required to file such reports), and (2)
has been subject to such filing requirements for the past 90 days.
Yes x No o
Check if
there is no disclosure of delinquent filers pursuant to Item 405 of Regulation
S-B is not contained herein, and no disclosure will 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-KSB or any amendment to
this Form 10-KSB. o
The
issuer’s revenues for the fiscal year ended December 31, 2004 were $1,485,148.
The
aggregate market value of the voting common stock of the issuer held by
non-affiliates of the issuer on March 14, 2005 based on the $.90 closing price
of the common stock as quoted by the NASD Over-the-Counter Bulletin Board on
such date was $10,220,443.
As of
March 14, 2005 there were 17,827,924 outstanding shares of common stock, par
value $.01 per share.
Transitional
Small Business Disclosure Format: Yes o No
x
TABLE
OF CONTENTS
|
|
Page |
PART
I
|
|
|
Item
1
|
Description
of Business
|
1
|
Item
2
|
Legal
Proceedings
|
17
|
Item
3
|
Description
of Property
|
17
|
Item
4
|
Submission
of Matters to a Vote of Security Holders
|
18
|
PART
II
|
|
|
Item
5
|
Market
for Common Equity and Related Stockholder Matters
|
19
|
Item
6
|
Management’s
Discussion and Analysis of Financial Condition and Results of Operations
or Plan of Operations |
20
|
Item
7
|
Consolidated
Financial Statements
|
27 |
Item
8
|
Changes
in and Disagreements with Accountants on Accounting and Financial
Disclosure
|
27 |
Item
8A
|
Controls
and Procedures
|
27 |
Item
8B
|
Other
Information
|
27 |
PART
III
|
|
|
Item
9
|
Directors,
Executive Officers, Promoters and Control Persons; Compliance with Section
16(a) of the Exchange Act
|
28 |
Item
10
|
Executive
Compensation
|
32 |
Item
11
|
Security
Ownership of Certain Beneficial Owners and Management and Related
Stockholder Matters
|
35 |
Item
12
|
Certain
Relationships and Related Transactions
|
36 |
Item
13
|
Exhibits
|
37 |
Item
14
|
Principal
Accountant Fees and Services
|
39 |
|
Signatures
|
40 |
|
Index
to Consolidated Financial Statements
|
F-1 |
References
to the “Company,” the “Registrant,” “we,” “us,” “our” or in this Annual Report
on Form 10-KSB refer to VioQuest Pharmaceuticals, Inc., formerly Chiral Quest,
Inc., a Minnesota corporation, and our consolidated subsidiaries, together taken
as a whole, unless the context indicates otherwise.
Forward-Looking
Statements
This
Annual Report on Form 10-KSB contains statements that are not historical but are
forward-looking in nature, including statements regarding our current
expectations, beliefs, intentions or strategies regarding the future. In
particular, the “Risk Factors” section following Item 1 and the “Management’s
Discussion and Analysis of Financial Condition and Results of Operations”
section in Item 6 of this annual report include forward-looking statements that
reflect our current views with respect to future events and financial
performance. We use words such as we “expect,” “anticipate,” “believe,” and
“intend” and similar expressions to identify forward-looking statements.
Investors should be aware that actual results may differ materially from our
expressed expectations because of risks and uncertainties inherent in future
events, particularly those risks identified in the subsection entitled “Risk
Factors” following Item 1 in this Annual Report, and should not unduly rely on
these forward looking statements.
PART
I
ITEM
1. DESCRIPTION
OF BUSINESS
Overview
VioQuest
Pharmaceuticals, Inc. has two subsidiaries - VioQuest Drug Development, Inc.,
which was created for the purpose of acquiring, developing and eventually
commercializing human therapeutics in the areas of oncology, metabolic and
inflammatory diseases and disorders that are current unmet medical needs, and
Chiral Quest, Inc., which continues our historical business of providing chiral
products, technology and services to pharmaceutical and fine chemical companies
in all stages of the product lifecycles with innovative chiral products and
services. Chiral Quest has two main lines of products and services - proprietary
chiral catalysts and chiral building blocks or client-defined molecules. We have
the rights to certain chemical compounds known as chiral ligands which, with the
introduction of a metal, serve as catalysts in facilitating the production of
chiral molecules in such a manner that there is a preferential manufacture of
the desired molecule versus the unwanted mirror-image molecule. We provide
pharmaceutical and fine chemical manufacturers and other prospective clients
with broad access to our technologies for testing purposes at a low upfront
cost, coupled with the opportunity to gain access to such technologies for
specific applications for fees, royalties and certain manufacturing and
development rights. Our ligands may also find use in producing fine chemicals
other than pharmaceuticals - chiral molecules are used in flavors, fragrances,
agrochemicals, animal health, food and feed additives (including vitamins) and
nutraceuticals. In connection with our chiral technology, we provide specialized
services to pharmaceutical, biotechnology and fine chemical companies relating
to the development of chiral manufacturing processes for their
products.
Our
proprietary chiral technology was developed by Dr. Xumu Zhang, a professor at
Pennsylvania State University (“Penn State”) and is owned by the Penn State
Research Foundation (“PSRF”), the technology development arm of Penn State. In
November 2000, we obtained from the PSRF an exclusive, worldwide license to
certain patents based on Dr. Zhang’s research relating to asymmetrical
catalysis. This license gives us the right to, among other things, sub-license
technology rights on a non-exclusive basis to clients, or sell molecule groups,
known as ligands, to pharmaceutical and fine chemical company clients for both
research and commercial applications.
Through
Chiral Quest, we are also engaged in developing and making client-defined
building blocks and drug candidate fragments, mainly in the chiral area. With
this process chemistry offering to life sciences companies, we develop new
synthetic routes or optimize existing ones and produce certain quantities of
material for further processing at the clients’ needs either for further
elaboration, clinical trials or beyond.
We are a
Minnesota corporation that resulted from the reverse merger of Chiral Quest,
LLC, a Pennsylvania limited liability company that commenced operations in
October 2000, and Surg II, Inc., a Minnesota corporation, on February 18,
2003.
Chiral
Business
Over 50
percent of the 500 top-selling pharmaceutical drugs on the market are comprised
of chiral molecules, including drugs used to treat anxiety, depression,
indigestion, heartburn, cancer, arthritis, AIDS and allergies. In 2004, chiral
drug sales were over $175 billion, based on a report in SRI
Consulting, which
represents over one third of the complete drug market of over $470 billion. The
majority of new drug candidates under development by pharmaceutical companies
consist of chiral chemicals.
A
molecule is considered “chiral” because it exists in two “enantiomers,” or
non-superimposable mirror-like images analogous to one’s left and right hands.
Most drugs interact with biological targets in a specific manner, requiring the
drug to be of a specific shape and orientation. Contaminating “wrong-handed”
enantiomers of the active drug molecule will probably not interact with the
biological drug target, or worse, interact with a different biological molecule
in an unintended and often toxic manner. Thalidomide, the morning sickness drug
used by pregnant women in the 1960’s, is a notorious example of an impure chiral
drug. One enantiomer of the drug’s chiral molecules treated morning sickness,
while its undesired enantiomer impurity caused birth defects. Pharmaceutical
companies are typically required, at great expense, to purify the active
mirror-image form of the drug molecule away from its contaminating or inactive
counterpart.
Products
and Services
We offer
two business lines, one in products and one in services in order to provide
clients with critical solutions for the efficient manufacturing of chiral
products or therapeutic drugs. Its products include bulk chiral catalysts,
proprietary building blocks / client-defined targets and a proprietary “Chiral
ToolKit”, comprised of a diverse set of chiral ligands that are combined with
transition metals to catalyze reactions leading to chiral molecules. Chiral
Quest also offers a variety of services covering specialized chiral
transformation screening, chiral synthetic or process support and manufacturing
solutions to be delivered on a partnership/contract basis with client firms.
Chiral Quest products and services are applicable throughout the full life cycle
of a chiral drug, from early lead discovery, through development and in
commercialization.
The
Chiral Quest "CQ" Chiral Library depicted below identifies the current
commercial portfolio of proprietary ligands from which clients order both the
Chiral ToolKit selection sets for Research and Development testing as
well as bulk quantities for larger scale uses and
commercialization.
Chiral
ToolKit. We
currently sell products which represent several of the proprietary families of
our chiral ligands to which the Company has exclusive rights. These ligands are
sold in research quantities packaged in convenient Chiral ToolKit sets for
exclusive use in research applications by client companies. These innovative,
patent protected ligands are screened by clients for applications in the
manufacture of their chiral molecules. Clients use this screening process to
determine which ligands may prove optimal for their chiral manufacturing needs.
The sale of research quantities of ligands allows clients to gain initial access
to our technology and to independently validate the advantages provided by that
technology.
Bulk
Ligands. We also
sell larger quantities of proprietary chiral ligands to which we have exclusive
rights, including some that are not included in our Chiral ToolKit. These
ligands are sold individually to clients in amounts specified by the client
according to its research, development or semi-commercial needs. One of our
objectives is to provide clients with their required ligands and catalysts,
either from our own laboratories or through third parties, for research,
clinical and commercial purposes. The use of CQ bulk ligands in commercial drug
applications will generally require license fees and/or other related payments
to us, subject to negotiation.
Screening
Services. We also
provide focused screening of client supplied target compounds using our
proprietary ligands. In addition to the select ligands included in the Chiral
ToolKit, we have several families of chiral ligands that are used to screen
target compounds. We identify and prepare individual ligands optimized for
particular client needs.
Proprietary
Building Blocks / Client-Defined Targets. We work
with our clients to help optimize the conditions under which our ligands are
used and also produce certain molecules of customer interest. This may involve
the development of novel manufacturing processes, for which we will derive
additional compensation. We may also structure our client agreements to assure
the use of our ligands within the manufacturing process, thereby requiring our
customers to buy the ligands from us in commercial quantities in order for the
client to successfully manufacture its compound. We may also produce and sell
certain selected chiral products defined by our clients such as chiral building
blocks or intermediates.
Strategy
Our
business strategy is focused on exploiting our asymmetric catalysis technology
by:
•
Focusing
our research group on designing and discovering additional commercially useful
ligands and manufacturing processes;
•
Providing
screening services necessary to test the selectivity and activity of a broad
portfolio of proprietary technologies for client substrates;
•
Granting
access to a selection of our ligands through non-exclusive licenses for research
and development purposes;
•
Granting
compound-specific exclusive rights to clients whose businesses require
commercial use of one or more of our ligands;
•
Developing
proprietary process methods for producing chirally pure pharmaceutical
ingredients, intermediates and building blocks in exchange for fees, milestone
payments and royalties; and
•
Assisting
clients in the development of chiral drugs, the development of which has been
slowed or halted due to manufacturing inefficiencies, which are amenable to
improvements through our technology.
Sales
and Marketing
We sell
our products and services directly to clients both in the pharmaceutical and
fine chemical areas. In October 2003, and January 2005, we hired a senior
executive and Vice President of Business Development respectively who are
focused on sales and marketing activities. We intend to hire additional
marketing personnel in the near future.
Dependence
on Certain Customers
In fiscal
2004, we had two customers that accounted for approximately 34 percent and 26
percent of our revenue, a major pharmaceutical company and biotech company
respectively. The loss of these accounts would have a material adverse effect on
our business; however, we believe our relationships with these customers are
strong.
Competition
Competition
in the traditional area of separation manufacture of chiral molecules comes from
a few distinct sources, including Chiral Technologies Inc., ChromTech Ltd.,
NovaSep, Inc. and Advance Separation Technologies Inc. Traditional methods of
manufacturing chiral molecules involve the production of a mixture of both
chiral forms of molecules of interest, followed by a process which separates the
desired enantiomer from the undesired enantiomer. This methodology, though still
commonly used, is extremely cost-ineffective, as it results in the loss of
greater than 50 percent of the intermediate product at each chiral purification
step. We believe we have a competitive advantage over companies using
traditional methods of separation because our technology drives the preferential
manufacture of chiral enantiomers of interest, which can result in 95 to 99
percent yields. This can result in significant cost savings in the manufacturing
process, particularly for chiral molecules that may require several chiral
separation steps by traditional methods.
In the
area of chemical catalysts for chiral drug manufacture, we compete with
pharmaceutical and fine chemical companies, including our current and potential
clients and collaborators, academic and research institutions. Some of these
companies include the Dow Chemical Company, Degussa AG, Rhodia ChiRex Inc. and
Solvias AG. Many of these companies are developing or marketing technologies and
services similar to the ones developed or offered by us. We anticipate continued
competition from other manufacturers of chiral catalysts in the
future.
Some of
our competitors, such as Codexis, a wholly owned subsidiary of Maxygen, or
Diversa Corporation, attempt to genetically modify biological enzymes for the
purpose of serving as biological catalysts for asymmetric chiral manufacturing.
While this approach works in certain circumstances, it is extremely
time-consuming to develop for each individual manufacturing process. We believe
our technology has the competitive advantage of being more broadly applicable to
a number of common asymmetric transformations.
Drug
Development
Through
our VioQuest Drug Development subsidiary, we plan to acquire, develop and bring
to market therapies for oncology, metabolic and inflammatory diseases and
disorders that are current unmet medical needs. We do not currently own the
rights to develop or commercialize any drug candidate, but are actively seeking
to acquire the rights to develop and commercialize novel therapeutic drug
candidates. Because pharmaceutical products are often in development for several
years before final approval from the FDA is obtained, if ever, we do not expect
that VioQuest Drug Development will generate any revenues from operations for a
number of years after we acquire a drug candidate. Additionally, because drug
development requires large investments of time, effort and money, we will need
significant additional financing in order to complete the development of any
drug candidate.
Intellectual
Property
License
with the Penn State Research Foundation. We have
an exclusive, worldwide license from the PSRF to certain chiral technologies
developed by Dr. Zhang. The license agreement has been amended on five
occasions, four of which provide us with additional rights, including the rights
to new patent applications. The PSRF license agreement grants us rights to any
conversions, re-issues, extensions, divisional applications, continuations,
continuations in part, and any patents issuing thereon, and any improvements to
the licensed patents. Under the license agreement, the PSRF received an equity
stake in our Company as partial consideration for the license. The license
agreement also obligates us to reimburse the PSRF for its patent expenses
relating to the licensed technology.
The PSRF
license agreement requires us to use our reasonable best efforts to achieve
annual gross revenue of $250,000 in calendar year 2004, which we
achieved, and at least $350,000 in calendar year 2005, and at least
$500,000 in calendar year 2006. Should we fail to obtain these milestones, the
PSRF has the right, but not the obligation, to terminate the license agreement
on the grounds that we failed to use our best efforts to achieve those
milestones.
Additionally,
in accordance with the license agreement, the PSRF’S obligation to license to
us, at no additional cost, any new technology subsequently discovered by Dr.
Zhang and the other researchers at Penn State expired on November 8, 2002.
Accordingly, if Dr. Zhang develops a new invention that does not constitute an
“improvement” on the existing patent rights, then we will have to license the
right to such invention from the PSRF.
Patents. Chiral
Quest has an exclusive license to 13 United States patent applications filed by
the Penn State Research Foundation covering many classes of ligands. The U.S.
Patent and Trademark Office ("PTO") has issued seven (7) letters of patents in
connection with these applications (i.e., U.S. Pat. Nos. 6,380,392, 6,525,210,
6,521,769, 6,337,406, 6,576,772, 6,534,657 and 6,653,485). In addition, the PTO
has issued notices of allowance on one (1) other application for which we
anticipate a patent being issued in 2004. The remaining five (5) patent
applications are still pending. Chiral Quest also has rights to international
patent applications based on many of the US application filings. National Phase
Applications have been filed for six (6) international applications (PCT)
corresponding to the originally filed U.S. applications.
Employees
and Consultants
We
currently employ 27 people: Daniel Greenleaf, our President, and Chief Executive
Officer, Brian Lenz our Chief Financial Officer and Corporate Secretary, Ronald
Brandt our Business Unit Head of Chiral Quest, Yaping Hong our Vice President of
Research and Development, Michael Cannarsa our Vice President of Business
Development, Bing Yu, our Director of Global Operations, and 20 full time
chemists. We also engage Dr. Xumu Zhang, who serves as our Chief Technology
Officer, on a consultancy basis. Additionally, we fund four post-doctoral
fellows, under the supervision of Dr. Zhang, pursuant to an agreement with Penn
State. Of the 32 persons providing services to our Company, either as employees
or consultants, 16 hold Ph.D. degrees. As we develop our technology and
business, we anticipate the need to hire additional employees, especially
employees with expertise in the areas of chemistry, sales and
marketing.
RISK
FACTORS
Risks
Related to Our Securities
Trading
of our common stock is limited, which may make it difficult for you to sell your
shares at times and prices that you feel are
appropriate.
Trading
of our common stock, which is conducted on the Over-the-Counter Bulletin Board
(or “OTC Bulletin Board”), has been limited. This adversely effects the
liquidity of our common stock, not only in terms of the number of shares that
can be bought and sold at a given price, but also through delays in the timing
of transactions and reduction in security analysts’ and the media’s coverage of
us. This may result in lower prices for our common stock than might otherwise be
obtained and could also result in a larger spread between the bid and asked
prices for our common stock.
Because
it is a “penny stock,” it will be more difficult for you to sell shares of our
common stock.
In
addition, our common stock is considered a “penny stock” under SEC rules because
it has been trading on the OTC Bulletin Board at a price lower than $5.00.
Broker-dealers who sell penny stocks must provide purchasers of these stocks
with a standardized risk-disclosure document prepared by the SEC. This document
provides information about penny stocks and the nature and level of risks
involved in investing in the penny-stock market. A broker must also give a
purchaser, orally or in writing, bid and offer quotations and information
regarding broker and salesperson compensation, make a written determination that
the penny stock is a suitable investment for the purchaser, and obtain the
purchaser’s written agreement to the purchase. Broker-dealers also must provide
customers that hold penny stocks in their accounts with such broker-dealer a
monthly statement containing price and market information relating to the penny
stock. If a penny stock is sold to you in violation of the penny stock rules,
you may be able to cancel your purchase and get your money back. The penny stock
rules may make it difficult for you to sell your shares of our stock, however,
and because of the rules, there is less trading in penny stocks. Also, many
brokers simply choose not to participate in penny-stock transactions.
Accordingly, you may not always be able to resell shares of our common stock
publicly at times and prices that you feel are appropriate.
Our
stock price is, and we expect it to remain, volatile, which could limit
investors’ ability to sell stock at a profit.
The
volatile price of our stock makes it difficult for investors to predict the
value of their investment, to sell shares at a profit at any given time, or to
plan purchases and sales in advance. A variety of factors may affect the market
price of our common stock. These include, but are not limited to:
· |
announcements
of technological innovations or new commercial products by our competitors
or us; |
· |
developments
concerning proprietary rights, including
patents; |
· |
regulatory
developments in the United States and foreign
countries; |
· |
economic
or other crises and other external factors;
|
· |
period-to-period
fluctuations in our revenues and other results of
operations; |
· |
changes
in financial estimates by securities analysts;
and |
· |
sales
of our common stock. |
We will
not be able to control many of these factors, and we believe that
period-to-period comparisons of our financial results will not necessarily be
indicative of our future performance.
In
addition, the stock market in general, and the market for biotechnology
companies in particular, has experienced extreme price and volume fluctuations
that may have been unrelated or disproportionate to the operating performance of
individual companies. These broad market and industry factors may seriously harm
the market price of our common stock, regardless of our operating
performance.
Because
we do not expect to pay dividends, you will not realize any income from an
investment in our common stock unless and until you sell your shares at
profit.
We have
never paid dividends on our common stock and do not anticipate paying any
dividends for the foreseeable future. You should not rely on an investment in
our stock if you require dividend income. Further, you will only realize income
on an investment in our shares in the event you sell or otherwise dispose of
your shares at a price higher than the price you paid for your shares. Such a
gain would result only from an increase in the market price of our common stock,
which is uncertain and unpredictable.
Risks
Related to Our Company
Our
future success is highly dependent on the continued availability of Dr. Xumu
Zhang and other key employees and consultants.
In
connection with the continued development of our products and services, we are
substantially dependent upon on the continued service of our existing research
personnel, including in particular, Xumu Zhang, Ph.D. Dr. Zhang, a professor at
Penn State, who serves as our Chief Technology Officer and provides essential
services to us pursuant to a consulting agreement. Although we maintain a $5
million key-man insurance policy with respect to Dr. Zhang and he has entered
into a non-compete agreement with us, the loss of his services would have a
material adverse effect on our business. In addition to Dr. Zhang, we employ
other research scientists who are also critical to our success. Although these
research scientists have entered into confidentiality agreements, most have not
entered into noncompete agreements with us. The loss of one or more of our
research personnel could prevent or delay the ongoing development of our
products and services, which would materially and adversely affect our
business.
We
have no meaningful operating history on which to evaluate our business or
prospects.
We
commenced operations in October 2000 and, therefore, have only a limited
operating history on which you can base an evaluation of our business and
prospects. Accordingly, our business prospects must be considered in light of
the risks, uncertainties, expenses and difficulties frequently encountered by
companies in their early stages of development, particularly companies in new
and rapidly evolving markets, such as the fine chemical, pharmaceutical and
biotechnology markets.
Our
management anticipates incurring losses for the foreseeable
future.
For the
year ended December 31, 2004, we had a net loss of $4,023,558 and since our
inception in October 2000 through December 31, 2004; we have incurred an
aggregate net loss of $7,434,763. As of December 31, 2004, we had total assets
of $4,876,741, of which $3,065,547 was cash or cash equivalents. We expect
operating losses to continue for the foreseeable future and there can be no
assurance that we will ever be able to operate profitably.
We
will require additional financing in order to complete the development of our
products and services and otherwise develop our business operations. Such
financing may not be available on acceptable terms, if at
all.
Following
the completion of our February 2004 private placement, we anticipate that our
current capital will be adequate to fund our operations through at least July
31, 2005. However, changes may occur that would consume available capital
resources before that time. Our combined capital requirements will depend on
numerous factors, including: competing technological and market developments,
changes in our existing collaborative relationships, the cost of filing,
prosecuting, defending and enforcing patent claims and other intellectual
property rights and the outcome of any potentially related litigation or other
dispute, the purchase of additional capital equipment, acquisition of
technologies, and the development and regulatory approval progress of our
customers’ product candidates into which our technology will be incorporated.
Additionally, working capital will be impacted by the costs associated with the
drug development process related to acquiring a drug candidate. Unless we are
able to significantly increase our revenues, we will most likely require
additional financing by the end of the second quarter of 2005 in order to
continue operations. The most likely source of such financing includes private
placements of our equity or debt securities or bridge loans to us from third
party lenders. These factors raise substantial doubt about our ability to
continue as a going concern.
Additional
capital that may be needed by us in the future may not be available on
reasonable terms, or at all. If adequate financing is not available, we may be
required to terminate or significantly curtail our operations, or enter into
arrangements with collaborative partners or others that may require us to
relinquish rights to certain of our technologies, or potential markets that we
would not otherwise relinquish.
Our
operating results will fluctuate, making it difficult to predict our results of
operations in any future period.
As we
develop our business, we expect our revenues and operating results to vary
significantly from quarter-to-quarter. As a result, quarter-to-quarter
comparisons of our revenues and operating results may not be meaningful. In
addition, due to the fact that we have little or no significant operating
history with our new technology, we cannot predict our future revenues or
results of operations accurately. Our current and future expense levels are
based largely on our planned expenditures and estimates of future revenues.
Accordingly, we may be unable to adjust spending in a timely manner to
compensate for any unexpected revenue shortfall, and any significant shortfall
in revenues relative to our planned expenditures could have an immediate adverse
effect on our business and results of operations.
We
may be unable to develop successful customer
relationships.
We intend
to establish relationships with various types of customers and partners, such as
pharmaceutical and fine chemical manufacturers. Each of these relationships will
involve negotiation of terms and fees. We cannot be certain that we will be able
to negotiate profitable relationships or that we can successfully fulfill our
obligations under development agreements that will allow us to continue these
relationships.
Our
license agreement with Penn State Research Foundation may be terminated if we do
not achieve certain milestones.
Our
business is based on technically complex products and services. We do not
directly own our proprietary technology, but rather we have the exclusive,
worldwide right to use it pursuant to a license agreement with the Penn State
Research Foundation. Currently, our commercial success depends entirely on this
licensed technology. Pursuant to the license agreement, we are required to use
our best efforts to achieve “gross revenue” (as defined in the license
agreement) of at least $250,000 in 2004 which we achieved, and at least $350,000
in 2005 and at least $500,000 in 2006. In the event we fail to achieve these
milestones in 2005 or 2006, or otherwise materially breach the license
agreement, the Penn State Research Foundation may have the right, but not the
obligation, to terminate the license. Unless we subsequently develop our own
technology independent of the Penn State Research Foundation, termination of
this license would preclude us from implementing our business plan.
We
will need to create and grow our scientific, sales and support
operations.
We will
need to create and substantially grow our direct and indirect sales operations,
both domestically and internationally, in order to create and increase market
awareness and sales of our products and services. The sale of our products and
services will require the engagement of sophisticated and highly knowledgeable
sales personnel. Similarly, the anticipated complexity of our products and
services and the difficulty of customizing them will require us to hire research
and development personnel and customer service and support personnel, highly
trained in chiral chemistry and chemical engineering. Competition among our
company and others to retain qualified sales personnel, chemists and chemical
engineers is intense due to the limited number of available qualified candidates
for such positions. Many of our competitors are in a financial position to offer
potential employees greater compensation and benefits than those which may be
offered by us. Failure to recruit and retain such persons will have a material
adverse effect on our business operations.
We
are dependent on a few customers.
We are
currently dependent on two customers who accounted for 34 percent and 26
percent, a major pharmaceutical company and a biotech company respectively, of
our fiscal 2004 revenue. The loss of either customer would have a material
adverse effect on our business.
Our
future success is dependent on the management of our potential
growth.
Our
future success depends upon our ability to grow our business. Such growth, if it
occurs, will require us to establish management and operating systems, hire
additional technical support and sales personnel, and establish and maintain our
own independent office, research and production facilities. Failure to manage
that growth efficiently could have a material adverse affect on our
business.
A
small group of persons is able to exert significant control over
us.
Our
current officers and directors beneficially own or control approximately 22% of
our common stock. Individually and in the aggregate, these persons will have
significant influence over the management of our business, the election of
directors and all matters requiring shareholder approval. In particular, this
concentration of ownership may have the effect of facilitating, delaying,
deferring or preventing a potential acquisition of our company and may adversely
affect the market price of our common stock. Additionally, two members of
our Board of Directors are employees of Paramount BioCapital, Inc., or one of
its affiliates. Dr. Lindsay A. Rosenwald is the chairman and sole owner of
Paramount BioCapital, Inc. and such affiliates. Dr. Rosenwald beneficially owns
5.5% of our outstanding common stock, and several trusts for the benefit of Dr.
Rosenwald and his family beneficially own 10.7% of our outstanding common stock.
Although Dr. Rosenwald does not have the legal authority to exercise voting
power or investment discretion over the shares held by those trusts, he
nevertheless may have the ability to exert significant influence over the
Company.
Risks
Relating to Our Industry
We
face intense competition.
We
compete directly with the in-house research departments of fine chemical,
pharmaceutical and biotechnology companies, as well as contract research
companies, and research and academic institutions. Many of our competitors have
greater financial and other resources than us. As new companies enter the market
and as more advanced technologies become available, we expect to face increased
competition. In the future, any one of our competitors may develop technological
advances that render obsolete the products or services that we provide or may
provide in the future. While we plan to develop new and better technologies,
which will give us competitive advantages, our competitors plan to do the same.
We may not be able to develop the technologies we need to successfully compete
in the future, and our competitors may be able to develop such technologies
before we do. Consequently, we may not be able to successfully compete in the
future.
The
fine chemical, pharmaceutical and biotechnology industries involve rapidly
changing technologies.
Rapid
technological change and uncertainty due to new and emerging technologies
characterize the drug and fine chemical development industries. We may not be
able to develop, integrate and market, on a timely basis, the new and enhanced
products and services necessary to keep pace with competitors. Failure to
anticipate or to respond to changing technologies, or significant delays in
product development or introduction, could cause our customers to delay or
decide against purchases of our products or services.
Since
many of or customers and potential customers are pharmaceutical and
biotechnology companies, we are and will be subject to risks, uncertainties and
trends that affect companies in these industries.
For the
foreseeable future, we will derive a substantial portion of our revenue from
pharmaceutical and biotechnology companies. As a result, we will be subject to
risks and uncertainties that affect the pharmaceutical and biotechnology
industries and possible reduction and delays in research and development
expenditures by companies in these industries. Our future revenues may also be
adversely affected by mergers and consolidation in the pharmaceutical and
biotechnology industries, which will reduce the number of potential
customers.
In
particular, pharmaceutical and biotechnology companies face significant
regulation by governmental entities in the United States and other countries.
The nature and the extent to which such regulation may apply to our customers
will vary depending on the nature of any such customers’ products. Most of the
pharmaceutical products developed by our customers will require regulatory
approval by governmental agencies prior to commercialization. In particular,
human pharmaceutical therapeutic products are subject to rigorous preclinical
and clinical testing and other approval procedures by the FDA and by foreign
regulatory authorities. Various federal and, in some cases, state laws also
govern or influence the manufacturing, safety, labeling, storage, record keeping
and marketing of such pharmaceutical products. The process of obtaining these
approvals and the subsequent compliance with appropriate federal and foreign
statutes and regulations are time consuming, can cause significant delays in the
commercialization of a drug, and often require the expenditure of substantial
resources. To the extent our customers experience significant delays in
obtaining the necessary regulatory approvals to market their pharmaceutical
products, or are unable to obtain such approvals at all, these customers will
not purchase our proprietary ligands and other services used in the manufacture
of the ultimate pharmaceutical product.
We
may be held liable for harm caused by drugs that our customers develop and
test.
Often
times, our ligands will be used by our customers to produce drugs for human use.
If any of the drugs cause injuries or illness to people, we may be required to
incur substantial costs in defending against claims and may be required to pay
damages arising therefrom. Although we have liability insurance and will use
commercially reasonable efforts to obtain indemnification covenants from our
customers for their use of our products, such protections may not be sufficient
to protect us from the cost of such claims. Damages awarded in a product
liability action could be substantial and could have a material adverse effect
on our financial condition.
We
may be held liable for contamination or other harm caused by hazardous materials
that we use.
Some of
our research and development processes involve the use of hazardous materials
and, therefore, we are subject to federal, state and local regulation governing
the use, manufacture, handling, storage and disposal of hazardous materials. We
cannot completely eliminate the risk of contamination or injury resulting from
hazardous materials and we may incur liability as a result of any contamination
or injury. We may also incur expenses relating to compliance with environmental
laws. Such expenses or liability may have a material adverse effect on our
financial condition.
Risks
Relating to Our Chiral Technology
We
may not be able to license technologies that we need to conduct our
business.
In
addition to the technologies that we develop, we will rely heavily on
technologies that we license from other companies or institutions. We may not be
able to license technologies that we need in the future or we may be unable to
license such technologies on a commercially reasonable basis. Although our
license agreement with the Penn State Research Foundation provides that we are
entitled to use any “improvements” subsequently made to the technologies we
currently license, the Penn State Research Foundation has no obligation to
license any “new” technologies discovered by Dr. Zhang and researchers at Penn
State. If we are unable to license the technologies we need in the future, or to
license or otherwise acquire such technologies on commercially reasonable terms,
we may experience increased costs (and, therefore, reduced profits) or be unable
to engage in certain activities that require those technologies. Accordingly,
failure to license the technologies we need in the future or otherwise acquire
such technologies on commercially reasonable terms could have a material adverse
effect on our business operations.
Our
success will depend on our ability to protect our proprietary
technology.
Our
rights to a substantial portion of our technology are as the exclusive licensee
to several United States patents and a number of United States and foreign
pending patent applications held by the Penn State Research Foundation,
including the ligands that comprise our Chiral ToolKit. These patents and patent
applications are based primarily upon the work of Dr. Zhang, our CTO, who is
also an associate professor at the Pennsylvania State University. Our success
will depend largely on our ability, and the ability of our licensors and
licensees, to obtain patents for their technologies and products, if any,
resulting from the application of such technologies, defend patents once
obtained, and maintain trade secrets.
If
we are unable to protect our intellectual property, or incur significant expense
in doing so, our business, operating results and financial condition may be
materially adversely affected. Any steps we take to protect our intellectual
property may be inadequate, time consuming and
expensive.
Our
success and ability to compete are substantially dependent upon our internally
developed products and services, which we currently protect through the use of
United States and foreign patents. To the extent such products and services are
not patentable, we will rely on trade secret protection. As with other
knowledge-based products, however, our patent positions rest on complex factual
and legal issues that are not entirely resolved and there can be no assurance
that the patents utilized by us will adequately protect our proprietary products
and services. Although we have taken steps to protect our unpatented trade
secrets and know-how, in part through the control of access to such information
and through the use of confidentiality agreements with our employees,
consultants and certain of our contractors, customers and potential customers,
there can be no assurance that these agreements will not be breached, that we
would have adequate remedies for any breach, or that our trade secrets will not
otherwise become known or be independently developed or discovered by
competitors. Despite our efforts to protect our proprietary rights, unauthorized
parties may attempt to copy or otherwise obtain and use our products or
technology. We anticipate that policing unauthorized use of our products will be
difficult, and we cannot be certain that the steps we intend to take to prevent
misappropriation of our technology, particularly in foreign countries where the
laws may not protect our proprietary rights as fully as in the United States,
will be successful. Other companies may also independently develop substantially
equivalent information.
Foreign
laws may not afford us sufficient protection for our intellectual property
rights and, in certain cases, we may not seek patent protection outside the
United States.
We
believe that our success will depend, in part, upon our ability to obtain
international protection for our intellectual property. We have existing foreign
customers and believe we will have access to large markets oversees. The laws of
some foreign countries may, however, not be as comprehensive as those of the
United States and may not be sufficient to protect our proprietary rights
abroad. In addition, in certain cases, we may decide not to pursue patent
protection outside the United States, because of cost and confidentiality
concerns. Accordingly, our international competitors could obtain foreign patent
protection for, and market overseas, technology for which we are seeking United
States patent protection, though such competitors’ patent protection generally
requires such competitors to make their patent filings prior to information on
our relevant inventions becoming sufficiently available under local law as to
block the availability of such competitors’ patent protection.
Our
technology may infringe on the proprietary rights of
others.
We
anticipate that other patents that we license or may license in the future will
be increasingly subject to infringement claims due to the rapid development of
chiral chemistry and competitors in our industry. In fact, one potential
competitor, Solvias, AG, based in Basel, Switzerland, notified us in July 23,
2002, of its claim that one of the patented ligands we license from the Penn
State Research Foundation infringes on a patent that Solvias licenses from BASF
Group, AG. Some of our other competitors or our potential competitors may have
filed or intend to file patent applications that may make claims that conflict
with the claims of the patents that we license. We cannot be certain that these
competitors or other third parties will not assert infringement claims against
us with respect to our products and technology. Any infringement claim,
including Solvias’ claim, regardless of its merit, could be time-consuming and
expensive to defend. Such claims may also require us to enter into royalty or
licensing agreements in order to continue using the disputed technology. In the
event we could not afford to defend our company against an infringement claim or
are not able to enter into a license or royalty agreement on commercially
favorable terms, or at all, we may be required to abandon the technology that is
subject to such claims.
Risks
Related to Our Proposed Drug Development Business
Until
we acquire the rights to develop or commercialize a biomedical or
biopharmaceutical product candidate, which will require substantial additional
funds, we will have no potential of ever generating any revenue.
We
currently do not have the rights to develop or commercialize any biomedical or
pharmaceutical product candidate and there can be no assurances that we will
ever be able to do so. In pursuing novel drug candidates, we will be competing
against fully integrated pharmaceutical companies, as well as smaller companies
that are seeking to acquire new technologies for their pipelines. We have
generated no revenues from operations or otherwise and will not be able to do so
until we acquire the rights to develop a product candidate and obtain the
necessary approvals from the Federal Drug Administration or counterpart
regulating authorities in other countries. We will likely require additional
financing, either by selling shares of our stock our borrowing funds from
others, in order to finance the acquisition of a product candidate, whether by
license or otherwise.
After
we obtain the rights to develop and commercialize a drug candidate, we will
require significant additional financing, which may not be available on
acceptable terms and will significantly dilute your ownership of our common
stock.
We will
not only require additional financing to acquire a drug candidate, but once
having acquired one, we will need significant additional financing to develop
and bring the drug to market. Our future capital requirements will depend on
numerous factors, including:
•
the terms
of our license agreements pursuant to which we obtain the right to develop and
commercialize drug candidates, including the amount of license fees and
milestone payments required under such agreements;
•
the
results of any clinical trials;
•
the scope
and results of our research and development programs;
•
the time
required to obtain regulatory approvals;
•
our
ability to establish and maintain marketing alliances and collaborative
agreements; and
•
the cost
of our internal marketing activities.
We will
likely look to obtain the necessary additional financing by selling shares of
our capital stock. If adequate funds are not available, we will be required to
delay, scale back or eliminate a future drug development program or obtain funds
through arrangements with collaborative partners or others that may require us
to relinquish rights to technologies or products that we would not otherwise
relinquish.
Upon
acquiring a drug candidate to develop, our drug development subsidiary will
experience significant negative cash flow for the foreseeable future and may
never become profitable.
Because
drug development takes several years and is extremely expensive, we expect that
our drug development subsidiary will incur substantial losses and negative
operating cash flow for the foreseeable future, and may never achieve or
maintain profitability, even if we succeed in acquiring, developing and
commercializing one or more drug candidates. In connection with our proposed
drug development business, we also expect to continue to incur significant
operating and capital expenditures and anticipate that our expenses will
increase substantially in the foreseeable future as we:
· |
acquire
the rights to develop and commercialize a drug
candidate; |
· |
undertake
pre-clinical development and clinical trials for drug candidates that we
acquire; |
· |
seek
regulatory approvals for drug candidates; |
· |
implement
additional internal systems and infrastructure;
|
· |
lease
additional or alternative office facilities;
and |
· |
hire
additional personnel. |
Our drug
development business may not be able to generate revenue or achieve
profitability. Our failure to achieve or maintain profitability could negatively
impact the value of our common stock.
If
we are not able to obtain the necessary U.S. or worldwide regulatory approvals
to commercialize any product candidates that we acquire, we will not be able to
sell those products.
We will
need FDA approval to commercialize drug candidates in the U.S. and approvals
from the FDA equivalent regulatory authorities in foreign jurisdictions to
commercialize our product candidates in those jurisdictions. In order to obtain
FDA approval of a drug candidate, we will be required to first submit to the FDA
for approval an Investigational New Drug Application, or an “IND,” which will
set forth our plans for clinical testing of a particular drug candidate.
When the
clinical testing for our product candidates is complete, we will then be
required to submit to the FDA a New Drug Application, or “NDA,” demonstrating
that the product candidate is safe for humans and effective for its intended
use. This demonstration will require significant research and animal tests,
which are referred to as pre-clinical studies, as well as human tests, which are
referred to as clinical trials. Satisfaction of the FDA’s regulatory
requirements typically takes many years, depends upon the type, complexity and
novelty of the product candidate and requires substantial resources for
research, development and testing. The FDA has substantial discretion in the
drug approval process and may require us to conduct additional pre-clinical and
clinical testing or to perform post-marketing studies. The approval process may
also be delayed by changes in government regulation, future legislation or
administrative action or changes in FDA policy that occur prior to or during our
regulatory review. Delays in obtaining regulatory approvals may:
· |
delay
commercialization of, and our ability to derive product revenues from, a
drug candidate; |
· |
impose
costly procedures on us; and |
· |
diminish
any competitive advantages that we may otherwise
enjoy. |
Even if
we comply with all FDA requests, the FDA may still ultimately reject an NDA.
Failure to obtain FDA approval of a drug candidate will severely undermine our
business development by reducing our ability to recover the development costs
expended in connection with a drug candidate and realize any profit from
commercializing a drug candidate.
In
foreign jurisdictions, we will be required to obtain approval from the
appropriate regulatory authorities before we can commercialize our drugs.
Foreign regulatory approval processes generally include all of the risks
associated with the FDA approval procedures described above.
Clinical
trials are very expensive, time-consuming and difficult to design and
implement.
Assuming
we are able to acquire the rights to develop and commercialize a product
candidate, we will be required to expend significant time, effort and money to
conduct human clinical trials necessary to obtain regulatory approval of any
product candidate. Human clinical trials are very expensive and difficult to
design and implement, in part because they are subject to rigorous regulatory
requirements. The clinical trial process is also time consuming. We estimate
that clinical trials of any product candidate will take at least several years
to complete. Furthermore, failure can occur at any stage of the trials, and we
could encounter problems that cause us to abandon or repeat clinical trials. The
commencement and completion of clinical trials may be delayed by several
factors, including:
· |
unforeseen
safety issues; |
· |
determination
of dosing issues; |
· |
lack
of effectiveness during clinical trials; |
· |
slower
than expected rates of patient recruitment; |
· |
inability
to monitor patients adequately during or after treatment;
and |
· |
inability
or unwillingness of medical investigators to follow our clinical
protocols. |
In
addition, we or the FDA may suspend our clinical trials at any time if it
appears that we are exposing participants to unacceptable health risks or if the
FDA finds deficiencies in our IND submissions or the conduct of these
trials.
The
results of any clinical trial may not support the results of pre-clinical
studies relating to our product candidate, which may delay development of any
product candidate or cause us to abandon development
altogether.
Even if
any clinical trials we undertake with respect to a future product candidate that
we acquire are completed as planned, we cannot be certain that their results
will support the findings of pre-clinical studies upon which a development plan
would be based. Success in pre-clinical testing and early clinical trials does
not ensure that later clinical trials will be successful, and we cannot be sure
that the results of later clinical trials will replicate the results of prior
clinical trials and pre-clinical testing. The clinical trial process may fail to
demonstrate that our product candidates are safe for humans and effective for
indicated uses. This failure may cause us to delay the development of a product
candidate or even to abandon development altogether. Such failure may also cause
delay in other product candidates. Any delay in, or termination of, our clinical
trials will delay the filing of our NDAs with the FDA and, ultimately, our
ability to commercialize our product candidates and generate product revenues.
If
physicians and patients do not accept and use our drugs after regulatory
approvals are obtained, we will not realize sufficient revenue from such product
to cover our development costs.
Even if
the FDA approved any product candidate that we acquired and subsequently
developed, physicians and patients may not accept and use them. Acceptance and
use of the product candidates we acquire (if any) will depend upon a number of
factors including:
· |
perceptions
by members of the health care community, including physicians, about the
safety and effectiveness of our drugs; |
· |
cost-effectiveness
of our product relative to competing
products; |
· |
availability
of reimbursement for our products from government or other healthcare
payers; and |
· |
effectiveness
of marketing and distribution efforts by us and our licensees and
distributors, if any. |
Because
our drug development business plan contemplates that substantially all of any
future revenues we will realize will result from sales of product candidates
that we develop, the failure of any of drugs we acquire and develop to find
market acceptance would significantly and adversely affect our ability to
generate cash flow and become profitable.
We
intend to rely upon third-party researchers and other collaborators who will be
outside our control and may not devote sufficient resources to our projects.
We intend
to collaborate with third parties, such as drug investigators, researchers and
manufacturers, in the development of any product candidate that we acquire. Such
third parties, which might include universities and medical institutions, will
likely conduct the necessary pre-clinical and clinical trials for a product
candidate that we develop. Accordingly, our successful development of any
product candidate will likely depend on the performance of these third parties.
These collaborators will not be our employees, however, and we may be unable to
control the amount or timing of resources that they will devote to our programs.
For example, such collaborators may not assign as great a priority to our
programs or pursue them as diligently as we would if we were undertaking such
programs ourselves. If outside collaborators fail to devote sufficient time and
resources to our drug-development programs, or if their performance is
substandard, the approval of our FDA applications, if any, and our introduction
of new drugs, if any, will be delayed. These collaborators may also have
relationships with other commercial entities, some of whom may compete with us
in the future. If our collaborators were to assist our competitors at our
expense, the resulting adverse impact on our competitive position could delay
the development of our drug candidates or expedite the development of a
competitor’s candidate.
We
will rely exclusively on third parties to formulate and manufacture our product
candidates.
We do not
currently have, and have no current plans to develop, the capability to
formulate or manufacture drugs. Rather, we intend to contract with one or more
manufacturers to manufacture, supply, store and distribute drug supplies that
will be needed for any clinical trials we undertake. If we
received FDA approval for any product candidate, we would rely on one or more
third-party contractors to manufacture our drugs. Our anticipated future
reliance on a limited number of third-party manufacturers will expose us to the
following risks:
· |
We
may be unable to identify manufacturers on commercially reasonable terms
or at all because the number of potential manufacturers is limited and the
FDA must approve any replacement contractor. This approval would require
new testing and compliance inspections. In addition, a new manufacturer
would have to be educated in, or develop substantially equivalent
processes for, production of our products after receipt of FDA approval,
if any. |
· |
Our
third-party manufacturers might be unable to formulate and manufacture our
drugs in the volume and of the quality required to meet our clinical needs
and commercial needs, if any. |
· |
Our
future contract manufacturers may not perform as agreed or may not remain
in the contract manufacturing business for the time required to supply our
clinical trials or to successfully produce, store and distribute our
products. |
· |
Drug
manufacturers are subject to ongoing periodic unannounced inspection by
the FDA, the DEA, and corresponding state agencies to ensure strict
compliance with good manufacturing practice and other government
regulations and corresponding foreign standards. We do not have control
over third-party manufacturers’ compliance with these regulations and
standards. |
· |
If
any third-party manufacturer makes improvements in the manufacturing
process for our products, we may not own, or may have to share, the
intellectual property rights to the
innovation. |
We may be
unable to identify manufacturers on acceptable terms or at all because the
number of potential manufacturers is limited and the FDA must approve any
replacement contractor. This approval would require new testing and compliance
inspections. In addition, a new manufacturer would have to be educated in, or
develop substantially equivalent processes for, production of our products after
receipt of FDA approval, if any.
If
we are not able to successfully compete against other drug companies, our
business will fail.
The
market for new drugs is characterized by intense competition and rapid
technological advances. If any drug candidate that we develop receives FDA
approval, we will likely compete with a number of existing and future drugs and
therapies developed, manufactured and marketed by others. Existing or future
competing products may provide greater therapeutic convenience or clinical or
other benefits for a specific indication than our products, or may offer
comparable performance at a lower cost or with fewer side-effects. If our
products fail to capture and maintain market share, we may not achieve
sufficient product revenues and our business will suffer.
We will
be competing against fully integrated pharmaceutical companies and smaller
companies that are collaborating with larger pharmaceutical companies, academic
institutions, government agencies and other public and private research
organizations. Many of these competitors have drug candidates already approved
or in development. In addition, many of these competitors, either alone or
together with their collaborative partners, operate larger research and
development programs and have substantially greater financial resources than we
do, as well as significantly greater experience in:
· |
undertaking
pre-clinical testing and human clinical
trials; |
· |
obtaining
FDA and other regulatory approvals of
drugs; |
· |
formulating
and manufacturing drugs; and |
· |
launching,
marketing and selling drugs. |
ITEM
2. LEGAL
PROCEEDINGS
We are
not a party to any material legal proceedings.
ITEM
3. DESCRIPTION
OF PROPERTY
We lease
office and laboratory space in Monmouth Junction, New Jersey; and in the
People’s Republic of China, as summarized below:
Monmouth
Junction, New Jersey. We
entered into a lease agreement effective June 1, 2003 for our principal
executive offices located in Monmouth Junction, New Jersey. This facility
consists of approximately 9,000 square feet of mostly laboratory space with some
additional office space at which our President and Chief Executive Officer,
Chief Financial Officer, Business Unit Head, Director of Global Operations and
vice president of business development maintain offices. We occupy this facility
pursuant to a May 2003 lease agreement, to which we pay approximately $17,000
per month for rent, and approximately $6,000 for utilities and maintenance fees.
Our total lease commitment of approximately $400,000 for rent, utilities and
maintenance fees, expires in May 2006. We use this facility to produce both
research and commercial quantities of our ligands and finished products. In
February 2004, and June 2004, we amended our lease agreement to add another
2,200 square feet of laboratory space in order to increase our capacity to
produce research and commercial quantities of our ligands.
The
People’s Republic of China. Pursuant
to an agreement with the Science and Technology Bureau of Jiashan County
(“Jiashan”) in Zhejiang Province of the People’s Republic of China, we have
agreed to lease a total of 4,000 square meters of laboratory space in an
industrial park near Shanghai, 15-20 percent of which we began occupying in
2004. Jiashan is currently building this facility to specifications and we
expect to occupy the facility in the second quarter of 2005. Pursuant to our
agreement with Jiashan, although we are not required to pay rent during the
initial 3-years of the lease, we will pay a maintenance fee of up to $4,500 per
month, which is comprised of maintenance and management fees. Following the
initial 3-year term, we may, at our sole discretion, either continue leasing the
space for annual rent of no more than $60,000 (at approximate conversion rate as
of December 31, 2004) or to purchase the facility on commercially reasonable
terms. We were also granted the option to purchase in the next three years
approximately 33 acres of land adjacent to the industrial park. For purposes of
entering into the lease, we established a wholly owned subsidiary organized
under the laws of Hong Kong, known as Chiral Quest Ltd., which in turn will be
the sole shareholder of a subsidiary in the People’s Republic of China, Chiral
Quest (Jiashan) Ltd.
We
believe our existing facilities, as described above, are adequate to meet our
needs through the year ending December 31, 2005.
ITEM
4. SUBMISSION
OF MATTERS TO A VOTE OF SECURITY HOLDERS.
During
the fourth quarter of fiscal year 2004, there were no matters submitted to a
vote of our shareholders.
PART
II
ITEM
5. MARKET
FOR COMMON EQUITY AND RELATED STOCKHOLDER MATTERS
Market
for Common Stock
Since
August 27, 2004 our common stock has traded on the OTC Bulletin Board under the
symbol “VQPH.OB”. From February 18, 2003, our common stock traded on the OTC
Bulletin Board under the symbol “CQST.OB.” From October 4, 2002 to February 18,
2003, our common stock traded under the symbol “SURG.OB.” The following table
lists the high and low bid price for our common stock as quoted, in U.S.
dollars, by the NASD’s OTC Bulletin Board, as applicable, during each quarter
within the last fiscal year. These quotations reflect inter-dealer prices,
without retail mark-up, markdown, or commission and may not represent actual
transactions. Trading on our common stock has been sporadic, exemplified by the
low trading volume and many days upon which no trades occurred.
|
|
2004 |
|
2003 |
|
Quarter
Ended |
|
High |
|
Low |
|
High |
|
Low |
|
March
31 |
|
$ |
1.76 |
|
$ |
1.76 |
|
$ |
1.65 |
|
$ |
1.62 |
|
June
30 |
|
|
1.05 |
|
|
1.05 |
|
|
2.50 |
|
|
1.55 |
|
September
30 |
|
|
1.25 |
|
|
1.25 |
|
|
2.23 |
|
|
2.00 |
|
December
31 |
|
|
0.95 |
|
|
0.80 |
|
|
1.83 |
|
|
1.50 |
|
Record
Holders
The
number of holders of record of our common stock as of March 22, 2005 was 1,502.
Dividends
We have
not paid or declared any dividends on our common stock and we do not anticipate
paying dividends on our common stock in the foreseeable future.
Stock
Re-Purchases
We did
not make any re-purchases of shares of our common stock during the fourth
quarter of fiscal 2004 and we do not currently have any publicly-announced
repurchase plans in effect.
ITEM
6. MANAGEMENT’S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS OR PLAN
OF OPERATIONS.
Overview
Since our
inception in October 2000, we have focused our efforts and resources on the
development of asymmetric catalysis technology, our primary intellectual
property to which we hold an exclusive worldwide license from the Pennsylvania
State Research Foundation (“PSRF”), the technology development arm of the
Pennsylvania State University (“Penn State”). Our license from PSRF covers
certain inventions discovered by our Chief Technology Officer (“CTO”) prior to
November 8, 2002.
In August
2004, the Company restructured operations by contributing all of its operating
assets relating to its asymmetric catalysis business, which has been its
historical business since inception, to its wholly- owned subsidiary, CQ
Acquisition, Inc., which was subsequently renamed Chiral Quest, Inc. In
addition, the Company changed its name to VioQuest Pharmaceuticals, Inc. and
formed a new wholly-owned subsidiary, called VioQuest Drug Development, Inc. As
a result, we have two subsidiaries - VioQuest Drug Development, Inc., which was
created for the purpose of acquiring, developing and eventually commercializing
human therapeutics, and Chiral Quest, Inc., which continues our historical
business of providing chiral products, technology and services to the
pharmaceutical and fine chemical industries. The Company develops chemical
catalysts and other products used in the synthesis of desired isomers of chiral
molecules.
Since
inception we have incurred a cumulative deficit of $7,434,763 through December
31, 2004. We expect our operating losses to increase over the next several
years, primarily due to expansion of our research and development programs, the
hiring of additional chemists, and the expansion of our manufacturing
capabilities.
The
accompanying financial statements have been prepared assuming that we will
continue as a going concern. We have had a net loss of $7,434,763 since
inception, and cash used in operating activities totaled $3,786,173 in 2004.
These matters raise doubt about our ability to continue as a going concern.
Management’s plan in regards to these matters is described in the Notes to the
Financial Statements.
Our
ability to achieve profitability depends upon, among other things, our ability
to discover and develop products (specifically new “ligands”), and to develop
our products on a commercial scale through a cost effective and efficient
process. To the extent that we are unable to produce, directly or indirectly,
ligands in quantities required for commercial use, we will not realize any
significant revenues from our technology. Moreover, there can be no assurance
that we will ever achieve significant revenues or profitable operations from the
sale of any of our products or technologies. Risks associated with our business
are more thoroughly addressed in the section entitled “Risk Factors.”
Since our
inception, we have generated sales revenue but not yet generated any net
profits. Our management believes that our research and development (“R&D”)
and manufacturing capacity will need to grow in order for us to be able to
obtain significant licensing and manufacturing agreements with large fine
chemical and pharmaceutical companies. We believe that our manufacturing
capacity will be enhanced with our new office and laboratory space located in
Monmouth Junction, New Jersey that was leased in June 2003, in addition to the
laboratory space acquired in October 2004, located in Jiashan, China.
On
February 18, 2003, we acquired Surg II, Inc., a Minnesota corporation (“Surg”),
in a reverse merger transaction (the “Merger”). Pursuant to the terms of the
Merger, Chiral Quest, LLC merged with and into a wholly-owned subsidiary of
Surg. In exchange for all of the outstanding membership interests of Chiral
Quest, LLC, Surg issued to the former member of Chiral Quest, LLC a number of
shares of Surg’s common stock that resulted in the members of Chiral Quest, LLC
owning two-thirds of Surg’s outstanding shares following the Merger. In
connection with the Merger, Surg changed its name to Chiral Quest, Inc., and
adopted the business plan of Chiral Quest, LLC. Accordingly, when we refer to
our business or financial information relating to periods prior to the Merger,
we are referring to the business and financial information of Chiral Quest, LLC,
unless the context indicates otherwise.
Results
of Operations – Years Ended December 31, 2004 vs.
2003
Our
revenues for the year ended December 31, 2004 were $1,485,148 as compared to
$669,036 for the year ended December 31, 2003. For the year ended December 31,
2004, approximately 8% of total revenue was derived from the amortization of
option fee income pertaining to the licensing of our intellectual property and
92% of total revenue was derived from sales of our ligands, feasibility
screening and customized process development services sold to third parties. For
the year ended December 31, 2003, approximately 20% of total revenue was derived
from the amortization of option fee income and 80% of total revenue was
comprised of sales or our ligands. It is anticipated that sales of our
proprietary technology consisting of ligands, molecular building blocks and
customized chiral services will continue to comprise a greater percentage of our
revenues in the future as we expand our manufacturing capabilities.
Cost of
goods sold for the year ended December 31, 2004 was $837,653 as compared to
$196,045 during the year ended December 31, 2003. The increase of cost of goods
sold is attributed to increased sales, associated manufacturing costs of scaling
operations to a commercialized level, in addition to the allocation of direct
labor and overhead expenses to finished goods. These expenses were allocated
from compensation and rent expenses as part of overall general operating
expenses.
Management
and consulting expenses for the year ended December 31, 2004 were $626,709 as
compared to $361,622 during the year ended December 31, 2003. The overall
increase in 2004 from 2003 was primarily caused by an increase in consulting
expense. Consulting expense increased due to the consultant agreement entered
with our CTO, which required us to make payments to our CTO of $10,000 per month
effective May 15, 2003. Management and consulting expense also increased as a
result of consulting fees paid to our Scientific Advisory Board members for
services provided during 2004. In addition, consulting expense increased from
the amortization of stock options issued to consultants, Scientific Advisory
Board members, during the second, third and fourth quarters of 2003.
Our
Research and Development (“R&D”) expenses for the year ended December 31,
2004 were $902,162 as compared to $440,646 during the year ended December 31,
2003. This increase resulted primarily from the manufacturing commercial scale
up of our proprietary ligands and catalysts. R&D expenses also increased as
a result of the utilization of the Penn State research resources in connection
with the development of new ligands. The agreement with Penn State required us
to fund services of four post-doctorate fellows who, under the supervision of
the CTO, conduct research and provide research quantities of chiral ligands to
us. This agreement has been extended to April 14, 2005. The approximate
obligation payable by us for the remaining period from January 1, 2005 through
the end of the agreement dated April 14, 2005 is approximately $98,000. From
October 2002 through December 31, 2004, the Company has paid and incurred
expenses of approximately $596,000 pursuant to the agreement. This amount
consists principally of four post-doctorate salaries, fringe benefits, materials
and supplies for the stated period. In addition, during the first and second
quarters of 2004, we expanded our laboratory facility in New Jersey, which
enabled us to commercialize our proprietary ligands and catalysts. In connection
with the facility’s expansion, numerous lab supplies and chemicals were
purchased. Accordingly, we incurred significant R&D expenses in the first
and second quarters due to the laboratory expansions of the New Jersey facility,
along with the increased costs of using the facility and chemists at Penn
State.
Selling,
general and administrative (“SG&A”) expenses for the year ended December 31,
2004 were $1,612,021 as compared to $1,012,182 during the year ended December
31, 2003. This increase in SG&A expenses was due in part to legal and
accounting fees associated with the private placement of our common stock in
February 2004, the reporting obligations as a public company, increased rent
expense for the New Jersey facility, additional spending on advertising and
promotion expenses, increased travel expenses for new business development
opportunities and higher administrative expenses associated with having more
employees such as insurance and employer payroll taxes.
Compensation
expense was $1,389,399 for the year ended December 31, 2004 as compared to
$601,780 for the year ended December 31, 2003. As a result of the resignation of
our CEO in April 2004, we incurred $375,000 in severance costs in 2004. In
addition, compensation expense increased due to the hiring of several lab
chemists to work at the newly expanded laboratory facility in New Jersey.
Compensation expense as it relates to direct labor for ongoing and completed
projects, has been capitalized as part of inventory work in process and finished
goods as these cost components relate directly to cost of goods sold.
Depreciation
and amortization expenses for the year ended December 31, 2004 were $179,034 as
compared to $86,325 during the year ended December 31, 2003. This increase was
primarily related to fixed asset purchases for office equipment, computer
equipment, laboratory equipment and leasehold improvements for the newly
expanded leased facility in New Jersey.
Interest
expense for the year ended December 31, 2004 was $0 as compared to $2,809 during
the year ended December 31, 2003. The interest expense for the year ended
December 31, 2003 is attributed to the promissory notes issued between July 2002
through February 2003 owed to a related party, which were fully paid and
discharged in February 2003.
Interest
income for the year ended December 31, 2004 was $38,272 as compared to $13,973
during the year ended December 31, 2003. The increase in interest income was
caused by significantly higher cash reserves obtained after private placement of
our common stock during February 2004.
Our net
loss for the year ended December 31, 2004 was $4,023,558 as compared to
$2,018,400 for the year ended December 31, 2003. The increased net loss in 2004
from 2003 was primarily due to increased SG&A expense from severance
compensation to our former CEO and the hiring of additional personnel, together
with increased R&D expense incurred as a result of the commercial scale up
of our proprietary catalysts and ligands, as well as increased legal and
accounting expenses associated with the private placement of our common stock,
and expenses in reporting as a public company. We expect losses to continue and
increase in the next year as we expand our laboratory space in China, purchase
more chemicals and raw material compounds, and hire additional employees.
Results
of Operations – Years Ended December 31,
2003 vs. 2002
Our
revenues for the year ended December 31, 2003 were $669,036 as compared to
$191,613 for the year ended December 31, 2002. The increase from fiscal 2002 can
be attributed to sales resulting from our proprietary catalyst and ligand
technology, contract research development and feasibility screening services
provided. For the year ended December 31, 2003 approximately 80% of total
revenue was derived from sales of our ligands, feasibility screening and
customized process development services sold to third parties and 20% of total
revenue was derived from the amortization of option fee income pertaining to the
licensing of our intellectual property. For the year ended December 31, 2002,
approximately 85% of total revenue was derived from the amortization of option
fee income and 15% of total revenue was comprised of sales or our ligands.
Revenues are comprised of our proprietary technology ligands and catalysts,
contract research development, feasibility screening in addition to licensing of
PSRF’s technology. We assume the financial risks related to these revenues by
financing the research and development of PSRF’s technology as well as the
defense of PSRF’s patents. It is anticipated that sales of our ligands,
molecular building blocks and customized chiral services will continue to
comprise a greater percentage of our revenues in the future as we expand our
manufacturing capabilities.
Cost of
goods sold for the year ended December 31, 2003 was $196,045 as compared to
$6,763 during the year ended December 31, 2002. The increase of cost of goods
sold is attributed to allocating material costs to specific projects as part of
finished goods during the year ended December 31, 2003, as compared to primarily
expensing materials, laboratory chemicals and supplies as part of operating
expenses during the year ended December 31, 2002.
Management
and consulting expense fees for the year ended December 31, 2003 were $361,622
as compared to $231,424 during the year ended December 31, 2002. The overall
change for the years ended December 2003 vs. 2002 was primarily caused by a
consulting agreement entered with our CTO at a rate of $10,000 per month
effective May 15, 2003.
Our
R&D expenses for the year ended December 31, 2003 were $440,646 as compared
to $63,728 during the year ended December 31, 2002. This change was primarily
caused by increased laboratory supplies and chemicals purchased during the year
ended 2003 in connection with the development of new ligands.
SG&A
expenses for the year ended December 31, 2003 were $1,012,182 as compared to
$193,449 during the year ended December 31, 2002. SG&A expenses increased
due in part to higher legal and accounting fees associated with our reporting
obligations as a public company, increased rent expense for the New Jersey
facility, additional spending on advertising and promotion expenses, increased
travel expenses for new business development opportunities and higher
administrative expenses associated with having more employees such as insurance
and employer payroll taxes.
Compensation
expense was $601,780 for the year ended December 31, 2003 as compared to
$197,596 for the year ended December 31, 2002. This increase was caused
primarily by hiring a CEO in November 2002 at an annual rate of $240,000, in
addition to hiring a vice president of business development, controller and
additional chemists to work at our New Jersey office and laboratory
facility.
Depreciation
and amortization expenses for the year ended December 31, 2003 were $86,325 as
compared to $36,631 during the year ended December 31, 2002. This increase was
primarily related to fixed asset purchases for office equipment, computer
equipment, and laboratory equipment, for our newly leased facility in New Jersey
during May 2003.
Interest
expense for the year ended December 31, 2003 was $2,809 as compared to $0 during
the year ended December 31, 2002. The interest expense for the year ended
December 31, 2003 is attributed to the promissory notes issued between July 2002
through February 2003 owed to a related party, which were fully paid and
discharged in February 2003.
Interest
income for the year ended December 31, 2003 was $13,973 as compared to $0 during
the year ended December 31, 2002. The increase in interest income in 2003 was
caused by higher cash reserves as a result of the proceeds received from the
reverse merger with Surg II, Inc. completed in February 2003.
Our net
loss for the year ended December 31, 2003 was $2,018,400 as compared to $537,978
for the year ended December 31, 2002. The higher loss for the year ended
December 31, 2003 as compared to December 31, 2002 was primarily due to higher
R&D expenses incurred with the purchases of laboratory supplies and
chemicals, management and consulting fees, in addition to the leasehold
improvement related to the newly leased facility in New Jersey as of May
2003.
Liquidity
and Capital Resources
As of
December 31, 2004, we had working capital of $2,721,707 and cash and cash
equivalents of $3,065,547. The Company will be unable to continue as a going
concern unless we are able to significantly increase our revenues or obtain
additional financing. We will most likely require additional financing by the
end of the second quarter of 2005 in order to continue operations. The most
likely source of such financing includes private placements of our equity or
debt securities or bridge loans to us from third party lenders.
Our net
cash used in operating activities for the year ended 2004 was $3,786,173 and our
net loss of $4,023,558 was offset by amortization of deferred expenses of
$296,385, deferred revenue of $304,134, and depreciation and amortization of
$179,034. Operating activities also included increases in accounts receivable of
$266,880 and inventory of $283,255.
Our net
cash used in investing activities for the year ended 2004 was $549,029.
Investing activities expenditures consisted of purchases of property and
equipment of $356,548 which was attributed to the laboratory expansions during
the second and third quarters of 2004, and payments for increased patent filings
of intellectual property rights of $192,481.
Our net
cash provided by financing activities for the year ended 2004 was $6,741,632.
Financing activities consisted of cash received as a result of a February 2004
private placement of approximately 4.8 million shares of our common stock at a
price per share of $1.50, and 5-year warrants to purchase one share of common
stock at $1.65 per share for every two common shares purchased in the offering.
Our
working capital requirements will depend upon numerous factors, including
without limitation the progress of our R&D programs, the resources we devote
to developing manufacturing and marketing capabilities, technological advances,
the status of competitors, and our ability to establish sales arrangements with
new customers. Working capital will also be affected by the China facility
expansion of office and laboratory space lease agreements that were entered into
during 2004, along with the hiring of additional employees. Our management
believes that by opening a facility in China to produce non-proprietary chemical
building blocks and related compounds, we will be able to significantly decrease
our manufacturing costs and expenses, which will enable us to cost-effectively
produce our ligands and end products and make our products substantially more
competitive and even more attractive to current and potential customers. We
expect operations to commence on a limited basis by April 2005.
Our
working capital requirements will also be substantially impacted by the costs
associated with the company’s drug development process. These costs of
acquiring, developing and eventually commercializing human therapeutics in the
areas of oncology, metabolic and inflammatory diseases and disorders that are
current unmet medical needs will significantly impact our working capital based
upon milestone payments, license fees and manufacturing costs. Upon acquiring a
drug candidate, we will need substantial additional capital to fund the
activities necessary to develop and eventually gain regulatory approval to sell
the drug.
Critical
Accounting Policies
Impairment
of Intellectual Property Rights
The
Company evaluates the recoverability of its long-lived assets, where indicators
of impairment are present, by reviewing current and projected profitability or
undiscounted cash flows of such assets. Intangible assets that are subject to
amortization are reviewed for potential impairment whenever events or
circumstances indicate that carrying amounts may not be recoverable. Intangible
assets not subject to amortization are tested for impairment at least annually.
For the years ended December 31, 2004 and 2003, the Company determined that
impairment to its long-lived assets did not occur. Accordingly, no impairment
loss was recorded for the years ended December 31, 2004 and 2003.
Revenue
Recognition
Revenues
are comprised principally of four main components: (1) the licensing of PSRF’s
technology, (2) the sale of proprietary ligands and catalysts, (3) feasibility
screening, and (4) custom contract development. Revenues as they relate to the
licensing of the Company's rights to PSRF's intellectual property are recognized
upon over the applicable license periods. The Company assumes the financial
risks related to these revenues by financing the research and development of
PSRF's technology as well as the defense of PSRF's patents. Deferred revenue in
the accompanying consolidated balance sheets represents amounts prepaid by
customers to the Company for services to be performed and products to be
delivered at a subsequent date. These deferred amounts will be recognized as
revenue when earned. Revenues as they relate to the sale of manufactured
proprietary ligands and catalysts are recognized upon the shipment of the
ligands to the customer. Revenues as they relate to feasibility screening are
recognized upon the completion of project reports and investigational studies.
Revenues as they relate to custom contract development are recognized upon the
shipment of finished products.
Accounting
for Stock-Based Compensation
The
Company accounts for its employee and director stock option plans in accordance
with APB 25, “Accounting For Stock Issued To Employees,” and related
interpretations. The Company measures compensation expense for employee and
director stock options as the aggregate difference between the market value of
its common stock and exercise prices of the options on the date that both the
number of shares the grantee is entitled to receive and the exercise prices are
known. Compensation expense associated with restricted stock grants is equal to
the market value of the shares on the date of grant and is recorded pro rata
over vesting period.
Off-Balance
Sheet Arrangements
The
Company does not have any off-balance sheet arrangements.
Recently
Issued Accounting Standards
In July
2002, the FASB issued SFAS No. 146, “Accounting for Restructuring Costs.” SFAS
No. 146 applies to costs associated with an exit activity (including
restructuring) or with a disposal of long-lived assets. Those activities can
include eliminating or reducing product lines, terminating employees and
contracts and relocating plant facilities or personnel. Under SFAS No. 146, the
Company will record a liability for a cost associated with an exit or disposal
activity when that liability is incurred and can be measured at fair value. SFAS
No. 146 will require the Company to disclose information about its exit and
disposal activities, the related costs, and changes in those costs in the notes
to the interim and annual financial statements that include the period in which
an exit activity is initiated and in any subsequent period until the activity is
completed. SFAS No. 146 is effective prospectively for exit or disposal
activities initiated after December 31, 2002, with earlier adoption encouraged.
Under SFAS No. 146, a company cannot restate its previously issued financial
statements and the new statement grandfathers the accounting for liabilities
that a company had previously recorded under Emerging Issues Task Force Issue
94-3.
In May
2003, the FASB issued SFAS No. 150, “Accounting For Certain Financial
Instruments with Characteristics of both Liabilities and Equity.” SFAS No. 150
changes the accounting for certain financial instruments with characteristics of
both liabilities and equity that, under previous pronouncements, issuers could
account for as equity. The new accounting guidance contained in SFAS No. 150
requires that those instruments be classified as liabilities in the balance
sheet.
SFAS No.
150 affects the issuer’s accounting for three types of freestanding financial
instruments. One type is mandatorily redeemable shares, which the issuing
company is obligated to buy back in exchange for cash or other assets. A second
type includes put options and forward purchase contracts, which involves
instruments that do or may require the issuer to buy back some of its shares in
exchange for cash or other assets. The third type of instruments that are
liabilities under SFAS No. 150 are obligations that can be settled with shares,
the monetary value of which is fixed, tied solely or predominantly to a variable
such as a market index, or varies inversely with the value of the issuers’
shares. SFAS No. 150 does not apply to features embedded in a financial
instrument that is not a derivative in its entirety.
Most of
the provisions of SFAS No. 150 are consistent with the existing definition of
liabilities in FASB Concepts Statement No. 6, “Elements of Financial
Statements.” The remaining provisions of SFAS No. 150 are consistent with the
FASB’s proposal to revise that definition to encompass certain obligations that
a reporting entity can or must settle by issuing its own shares. SFAS No. 150
shall be effective for financial instruments entered into or modified after May
31, 2003 and otherwise shall be effective at the beginning of the first interim
period beginning after June 15, 2003.
In
December 2003, the FASB issued revised FIN 46R, “Consolidation of Variable
Interest Entities, an Interpretation of Accounting Research Bulletin No. 51.”
(“FIN 46R”). FIN 46R required the consolidation of an entity in which an
enterprise absorbs a majority of the entity’s expected losses, receives a
majority of the entity’s expected residual returns, or both, as a result of
ownership, contractual or other financial interests in the entity (variable
interest entities, or “VIEs”). Currently, entities are generally consolidated by
an enterprise when it has a controlling financial interest through ownership or
a majority voting interest in the entity. FIN 46R is applicable for financial
statements of public entities that have interests in VIEs or potential VIEs
refereed to as special-purpose entities for periods ending after December 31,
2003. Applications by public entities for all other types of entities are
required in financial statements for periods ending after March 15, 2004.
In
December 2004, the FASB issued SFAS No. 123R “Accounting for Stock-Based
Compensation.” SFAS 123R establishes standards for the accounting for
transactions in which, an entity exchanges its equity instruments for goods
or services. This Statement focuses primarily on accounting for transactions in
which an entity obtains employee services in share-based payment transactions.
SFAS 123R requires that the fair value of such equity instruments, including
employee stock options, be recognized as an expense in the historical financial
statements as services are performed. Prior to SFAS 123R, only certain pro forma
disclosures of fair value were required. SFAS 123R shall be effective for the
Company as of the beginning of the first interim or annual reporting period that
begins after December 15, 2005. The Company is evaluating the impact of this
pronouncement and its affects on our financial statements.
ITEM
7. CONSOLIDATED
FINANCIAL STATEMENTS
For a
list of the consolidated financial statements filed as part of this report, see
the Index to Consolidated Financial Statements beginning at Page F-1 of this
annual report.
ITEM
8. CHANGES
IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL
DISCLOSURE
None.
ITEM
8A. CONTROLS
AND PROCEDURES
As of
December 31, 2004, we carried out an evaluation, under the supervision and with
the participation of our chief executive and chief financial officer, of the
effectiveness of the design and operation of our disclosure controls and
procedures (as defined in Rules 13a-15(e) and 15d-15(e) of the Securities
Exchange Act of 1934, as amended). Based upon that evaluation, our chief
executive officer and chief financial officer concluded that our disclosure
controls and procedures are effective in alerting them on a timely basis to
material information required to be disclosed in our periodic reports to the
Securities and Exchange Commission. There has been no change in our internal
controls over financial reporting during the fourth quarter of the year ended
December 31, 2004 that has materially affected, or is reasonably likely to
materially affect our internal controls over financial reporting.
ITEM
8B. OTHER
INFORMATION
None.
PART
III
ITEM
9. DIRECTORS,
EXECUTIVE OFFICERS, PROMOTERS AND CONTROL PERSONS; COMPLIANCE WITH SECTION 16(a)
OF THE EXCHANGE ACT
Information
Concerning Directors and Executive Officers
Our
executive officers and directors are described below:
Name |
Age |
Positions |
Daniel
Greenleaf. |
40 |
President,
Chief Executive Officer and Director |
Xumu
Zhang, Ph.D. |
44 |
Chief
Technology Officer and Director |
Ronald
Brandt |
57 |
Chiral
Business Unit Head and Director |
Michael
Cannarsa, Ph.D. |
48 |
Vice
President of Business Development |
Yaping
Hong, Ph.D. |
49 |
Vice
President of Process Research and Development |
Brian
Lenz |
32 |
Chief
Financial Officer and Secretary |
Stephen
C. Rocamboli |
33 |
Interim
Chairman |
Michael
Weiser, M.D., Ph.D. |
41 |
Director |
David
M. Tanen |
33 |
Director |
Vincent
Aita, Ph.D. |
31 |
Director |
Kenneth
W. Brimmer |
49 |
Director |
Stephen
A. Roth, Ph.D. |
62 |
Director |
Daniel
Greenleaf
Mr.
Greenleaf has been our President and Chief Executive Officer and a member of the
Board of Directors since February 2005. He joins VioQuest from Celltech
Biopharmaceuticals, a European biotechnology company where he served as
President of their U.S. operations since 2004.
Prior to that, Mr. Greenleaf served as Senior Vice President of Operations for
Nabi Biopharmaceuticals a biopharmaceutical development company, from
2002 to
2003.
From 1992 to 2002, Mr. Greenleaf held a series of positions of increasing
responsibility at Schering-Plough Corporation, an international pharmaceutical
company, including its Vice President, Marketing and Sales from 2000 to
2002. He
holds an MBA from the University of Miami and a BA in Economics from Denison
University.
Xumu
Zhang, Ph.D.
Dr.
Zhang, co-founder of Chiral Quest, Inc., has been a member of our board of
directors and has served as our Chief Technology Officer and as a consultant
since our inception in 2000. Since 1994, Dr. Zhang has been primarily employed
by Pennsylvania State University in State College, Pennsylvania, most recently
as a Professor of Organic Chemistry, and prior to that was an Assistant and
Associate Professor of Chemistry. Dr. Zhang holds a Ph.D. in Organic and
Inorganic Chemistry from Stanford University, where he also conducted his
postdoctoral work.
Ronald
Brandt
Mr.
Brandt is currently the Business Unit Head of Chiral Quest Inc., our wholly
owned subsidiary. From April 2004 to February 2005 he served as our Interim
Chief Executive Officer, and from October 2003 through April 2004 he was our
Vice President of Business Development. Mr. Brandt has also been a director of
our company since June 2004. Prior to joining our company, he was Executive Vice
President of Marketing & Sales at Ricerca Biosciences from October 2002 to
August 2003. Previous to Ricerca Biosciences, Mr. Brandt held senior Sales and
Business Development positions at ISP (International Specialty Products) from
October 1997 to July 2002. From November 1972 to January 1997, Mr. Brandt was
employed by Lonza Group in the U.S. and Europe, eventually serving as Senior
Vice President from June 1988 to January 1997. He holds a Bachelors of
Engineering, specializing in Chemical Engineering, from the Cooper Union, NY and
an M.B.A. from Rutgers University in New Jersey.
Michael
Cannarsa, Ph.D.
Dr.
Cannarsa has been our Vice President of Business Development since January 2005.
Mr. Cannarsa joins us from Chemi Pharma, where he served as President and VP of
Business Development since 2003. From 2001 to 2003, Dr. Cannarsa was employed by
Synthetech, Inc. serving as Director of Business Development. Prior to
Synthetech, Inc., Dr. Cannarsa served as Vice President, Fine Chemicals Business
Development at Symyx Technologies, Inc. from 1999 to 2001. From 1997 to 1999;
Dr. Cannarsa was employed by PPG-Sipsy Pharmaceutical Products as Commercial
Development Manager. He holds a Ph.D. from Cornell University in Physcial
Organic Chemistry, and a BS in Chemistry from Georgetown
Unviversity.
Yaping
Hong, Ph.D.
Dr. Hong
has been our Director of process Research and Development since May 2003. Prior
to joining Chiral Quest, Dr. Hong was Director of Process Chemistry for Synthon
Chiragenics from August 2001 to May 2003. From April 1993 to August 2001, Dr.
Hong was employed by Sepracor Inc., eventually serving as Associate Research
Fellow from January 2001 to August 2001. Dr. Hong holds a Ph.D. in Synthetic
Organic Chemistry from the University of Waterloo. Dr. Hong conducted his
postdoctoral work from September 1991 to March 1993 at the Massachusetts
Institute of Technology, in Cambridge Massachusetts.
Brian
Lenz
Mr. Lenz
has been our Chief Financial Officer since April 2004 and our Secretary since
December 2003. From October 2003 to April 2004, he served as our Controller.
Prior to that he was Controller of Smiths Detection from July 2000 to September
2003. Previous to Smiths Detection, Mr. Lenz worked as a Senior Auditor for KPMG
LLP from October 1998 to June 2000. Mr. Lenz is a licensed Certified Public
Accountant, holds a Bachelors of Science in Business Administration from Rider
University in New Jersey, and an M.B.A. from Saint Joseph’s University in
Pennsylvania.
Stephen
A. Roth, Ph.D.
Dr. Roth
has served as
a member of the board of directors since February
2003. Since January 2003, he has served as President, CEO, and director of
Immune Control, Inc., a privately-held biopharmaceutical company focused on
developing cancer treating drugs. Prior to joining Immune Control, Dr. Roth
co-founded Neose Technologies in 1990, becoming its Chief Executive Officer and
Chairman in 1994. Prior to starting Neose, Dr. Roth was assistant and associate
professor of biology at The Johns Hopkins University from 1970-1980. He moved to
the University of Pennsylvania as professor of biology in 1980, and was
appointed Department Chairman in 1982, serving in that role until 1987. At Penn,
Dr. Roth helped form its Plant Science Institute. His scholarly interests
centered on the roles of complex carbohydrates in embryonic morphogenesis and in
malignancy, topics on which he authored or co-authored nearly 100 articles and
one book. He has received several research awards and prizes, and is an inventor
on 18 patents and six patent applications. Dr. Roth received an A.B. degree from
Johns Hopkins in 1964, a Ph.D. from Case Western Reserve University in 1968, and
did postdoctoral work in carbohydrate chemistry at Hopkins from
1968-1970.
Stephen
C. Rocamboli
Mr.
Rocamboli has served as our Interim Chairman since February 2003 and was our
Secretary from February 2003 to December 2003. Since September 2004, Mr.
Rocamboli has been general counsel of Paramount BioCapital, Inc. and Paramount
BioCapital Investments, LLC and served as deputy general counsel of those
companies from September 1999 to August 2004. From November 2002 to December
2003, Mr. Rocamboli served as a director of Ottawa, Ontario based Adherex
Technologies, Inc. Mr. Rocamboli also serves as a member of the board of
directors of several privately held development stage biotechnology companies.
Prior to joining Paramount, Mr. Rocamboli practiced law in the health care
field. He received his J.D. from Fordham University School of Law.
Vincent
M. Aita, Ph.D.
Dr. Aita
has served as
a member of the board of directors since February
2003. Since February 2004, Dr. Aita has been an analyst for Kilkenny Capital
Management, LLC. Prior to that, he was a research analyst for Paramount
BioCapital Asset Management, Inc. from November 2000 to January 2004. Prior to
that, Dr. Aita completed a post-doctoral fellowship in the Department of
Genetics and Development at Columbia University, and concurrently served as a
scientific consultant for Research Assessment Associates, Inc. From August 1995
to December 1999, Dr. Aita attended Columbia University where he received a
Ph.D. in Genetics from the Columbia Genome Center.
Michael
Weiser, M.D., Ph.D.
Dr.
Weiser has served as a member of the board of directors since February 2003. Dr.
Weiser concurrently serves as the Director of Research of Paramount BioCapital
Asset Management. Dr. Weiser also is a member of the board of directors of
Manhattan Pharmaceuticals, Inc. (OTC: MHTT), and Hana Biosciences, Inc. (OTC:
HNAB), both publicly-held biotechnology companies. Dr. Weiser is also a member
of Orion Biomedical GP, LLC, and serves on the board of directors of several
privately held companies. Dr. Weiser holds an M.D. from New York University
School of Medicine and a Ph.D. in Molecular Neurobiology from Cornell University
Medical College. Dr. Weiser completed a Postdoctoral Fellowship in the
Department of Physiology and Neuroscience at New York University School of
Medicine and performed his post-graduate medical training in the Department of
Obstetrics and Gynecology and Primary Care at New York University Medical
Center.
David
M. Tanen
Mr. Tanen
has served as
a member of the board of directors since February
2003. Since September 2004, he has been a Partner of Two River Group Holdings, a
New York-based venture capital and investment banking firm, which he co-founded.
Prior to that, he was employed primarily as an associate director of Paramount
BioCapital, Inc. and Paramount BioCapital Investments, LLC since 1996, where he
has assisted in the founding of a number of biotechnology start-up companies.
Since January 2002, Mr. Tanen has served as a director of Manhattan
Pharmaceuticals, Inc. (OTCBB: MHTT), which develops pharmaceutical technologies,
and he also serves as a director of several privately held development stage
biotechnology companies. Mr. Tanen received his J.D. from Fordham University
School of Law.
Kenneth
W. Brimmer
Mr.
Brimmer has served as
a member of the board of directors since February
2003. From May 2002 to February 2003 he served as Chairman and Chief Executive
Officer of Surg II, Inc., with which we completed a reverse merger transaction
in February 2003. Mr. Brimmer has been chief manager of Brimmer Company, a
private investment company that he founded, since December 2001. Since September
2003, he has been Chief Executive Officer of STEN Corporation, a
Minneapolis-based diversified business medical products company, and has served
as the company's Chairman since March 2000. From April 2000 to December 2001,
Mr. Brimmer was Chief Executive Officer and Chief Financial Officer of
Minnetonka, Minnesota-based Active IQ Technologies, Inc. (nka Wits Basin
Precious Minerals, Inc.) and served as its Chairman from April 2000 to June
2003. From May 1995 until April 2000, Mr. Brimmer was treasurer of Rainforest
Café, Inc., and served as that company’s President from April 1997. From 1990
until 1997, Mr. Brimmer was also engaged in an executive position with
Minneapolis-based Grand Casino, Inc. Mr. Brimmer is currently the Chairman of
Sterion Incorporated, Entrx Corporation, and Spectre Gaming, Inc., and is a
director of Hypertension Diagnostics, Inc., all publicly-held companies. Mr.
Brimmer began his career as a certified public accountant.
Scientific
Advisory Board
K.
Barry Sharpless, Ph.D.
Dr.
Sharpless has served as the chairman of our Scientific Advisory Board since
February 2003. Dr. Sharpless is the W.M. Keck Professor of Chemistry at The
Scripps Research Institute and a member of the Skaggs Institute for Chemical
Biology. Dr. Sharpless is the world authority in chiral chemistry and is best
known for discovering three “name” reactions - the general methods for catalytic
asymmetric epoxidation, dihydroxlylation, and aminohydroxylation. His 2001 Nobel
Prize in Chemistry citation says, “many scientists have identified Sharpless’
epoxidation (discovered in 1980 with Tsutomu Katsuki) as the most important
discovery in the field of synthesis during the past few decades.” In 2000,
Chemical and Engineering News selected him as one of the top 75 most influential
chemists of the 20th century. In 2001, Sharpless received not only the Nobel
Prize in Chemistry, but also Israel’s Wolf Prize, the Benjamin Franklin Medal
and the John Scott Medal Award. After receiving his Stanford Ph.D. from
Professor E. E. vanTamelen, he did postdoctoral work with Professor James
Collman at Stanford University and Nobel Laureate Konrad Bloch at Harvard
University. Sharpless began his academic career as an assistant professor at the
Massachusetts Institute of Technology. Except for several years in the 1970s
when he was a member of Stanford’s chemistry faculty, Sharpless remained at MIT
until moving to the Scripps Research Institute (TSRI) in 1990.
James
P. Collman, Ph.D.
Dr.
Collman is the Daubert Professor of Chemistry at Stanford University where he
has been on the faculty for 35 years. Collman is a member of The National
Academy of Sciences and has received numerous awards for his research from the
American Chemical Society and other international organizations. More than
40 of his graduate and postdoctoral students occupy teaching positions at
universities around the world; twelve of Collman’s former students have founded
companies.
Code
of Ethics
We have
developed a Code of Ethics that applies to our President, Chief Executive
Officer & Chief Financial Officer which is expected to be presented to our
board of directors for its review and approval during the second quarter of
2005. Once adopted we will provide a copy of the Code of Ethics without charge
upon written request directed to Brian Lenz, 7 Deer Park Drive, Suite E,
Monmouth Junction, NJ 08852.
Audit
Committee Financial Expert
We have
an Audit Committee composed of Messrs. Brimmer, Rocamboli and Tanen and have
determined that Mr. Brimmer qualifies as an “audit committee financial expert,”
as that term is defined by SEC regulations. As indicated above, Mr. Brimmer has
previous experience as a certified public accountant. Although our common stock
is not listed on any of the New York Stock Exchange, American Stock Exchange or
the Nasdaq Stock Market, applicable SEC rules require us to determine whether
Mr. Brimmer is also an “independent director,” as that term is defined by the
listing standards of one of the foregoing stock markets. Mr. Brimmer is also an
“independent director,” as that term is defined by Section 121(A) of the listing
standards of the American Stock Exchange.
Section
16(a) Beneficial Ownership Reporting Compliance
Section
16(a) of the Securities Exchange Act of 1934, as amended, requires our officers,
directors and persons who are the beneficial owners of more than 10 percent of
our common stock to file with the SEC initial reports of ownership (on Form 3)
and reports of changes in ownership (on Form 4) of our common stock. Based
solely on a review of the copies of these reports that have been provided to us
with respect to transactions during fiscal 2004, we believe that all such
reports were filed on a timely basis, except for the following: Alan D. Roth,
who served as our President, Chief Executive Officer, Chief Financial Officer
and director of our company until April 2004, failed to file a Form 4 reporting
his February 25, 2004 purchase of 80,000 common shares and warrants to purchase
40,000 common shares in our February 2004 private placement.
ITEM
10. EXECUTIVE
COMPENSATION
Compensation
of Executive Officers
The
following table sets forth, for the last three fiscal years, the compensation
earned for services rendered in all capacities by those persons who served as
our chief executive officers during 2004 and the other highest-paid executive
officers serving as such at the end of 2004 whose compensation for that fiscal
year was in excess of $100,000. The individuals named in the table will be
hereinafter referred to as the “Named Officers.” No other executive officer of
the Company received compensation in excess of $100,000 during fiscal year 2004.
No executive officer who would otherwise have been included in this table on the
basis of 2004 salary and bonus resigned or terminated employment during that
year.
Summary
Compensation Table
|
Annual
Compensation |
Long-Term
Compensation Awards |
All
Other Compensation ($) |
Name
and Principal Position |
Year |
Salary($) |
Bonus($) |
Other
Annual Compensation ($) |
Securities
Underlying Options (#) |
Alan
D. Roth(1), President & CEO |
2004
2003
2002 |
240,000
205,000
-- |
0
35,000
-- |
0
0
-- |
0
865,230
-- |
375,000(1)
0
-- |
Ronald
Brandt(3), Business Unit Head |
2004
2003
2002 |
200,000
165,000
-- |
50,000
0
-- |
6,000(4)
4,800(4)
-- |
125,000
175,000
-- |
0
0
-- |
Brian
Lenz, CFO & Secretary |
2004
2003
2002 |
94,000
--
-- |
17,000
--
-- |
0
--
-- |
100,000
--
-- |
0
--
-- |
Yaping
Hong, Vice President R&D |
2004
2003
2002 |
165,000
145,000
-- |
20,000
14,000
-- |
0
0
-- |
75,000
50,000
-- |
0
0
-- |
(1) |
Mr.
Roth was our President, CEO and Chief Financial Officer until April 2004.
|
(2) |
Represents
severance compensation paid to Dr. Roth upon his separation from the
Company. |
(3) |
Mr.
Brandt served as the Company’s Vice President of Business Development from
October 2003 to April 2004. He was appointed interim President and CEO in
April 2004 and held those positions until February 2005.
|
(4) |
Mr.
Brandt’s other annual compensation is comprised of an annual auto
allowance. |
Options
and Stock Appreciation Rights
The
following table contains information concerning the grant of stock options under
our 2004 Stock Option Plan and otherwise to the Named Officer during the 2004
fiscal year. No stock appreciation rights were granted during the 2004 fiscal
year.
Option
Exercise and Holdings
The
following table provides information with respect to the Named Officer
concerning the exercisability of options during the 2004 fiscal year and
unexercisable options held as of the end of the 2004 fiscal year. No stock
appreciation rights were exercised during the 2004 fiscal year, and no stock
appreciation rights were outstanding at the end of that fiscal
year.
Aggregated
Option Exercises in Last Fiscal Year and Fiscal Year-End Option
Values
|
|
|
|
|
|
|
|
|
Securities
Underlying Unexercised Options
at FY-End (#) |
|
|
Value
of Unexercised In-the-Money Options at FY-End (Market price of
shares
at FY-End less exercise price)(2) |
|
Name |
|
|
Shares
Acquired
on
Exercise |
|
|
Value
Realized (1) |
|
|
Exercisable |
|
|
Unexercisable |
|
|
Exercisable |
|
|
Unexercisable |
|
Alan
Roth |
|
|
0 |
|
|
-- |
|
|
288,410 |
|
|
576,820 |
|
$ |
0 |
|
$ |
259,569 |
|
Ronald
Brandt |
|
|
0 |
|
|
-- |
|
|
58,333 |
|
|
241,667 |
|
$ |
0 |
|
$ |
52,500 |
|
Brian
Lenz |
|
|
0 |
|
|
-- |
|
|
5,000 |
|
|
95,000 |
|
$ |
0 |
|
$ |
4,500 |
|
(1) Equal to
the fair market value of the purchased shares at the time of the option exercise
over the exercise price paid for those shares.
(2)
Based on
the fair market value of our common stock on December 31, 2004 of $.90 per
share, the closing sales price per share on that date on the OTC Bulletin
Board.
Long
Term Incentive Plan Awards
No long
term incentive plan awards were made to the Named Officer during the last fiscal
year.
Compensation
of Directors
Our
directors receive no monetary fees for serving as directors. Non-employee
directors may be granted, at the discretion of the Board, options to purchase
shares of our common stock. Such options shall contain such terms and provisions
as the Board determines at the time of grant. On October 28, 2003, in
consideration for their services as directors, each of Drs. Aita, Stephen Roth
and Weiser and Messrs. Brimmer, Rocamboli and Tanen received ten-year options to
purchase 12,900 shares of our common stock at an exercise price of $1.98 per
share. All of these options vest in three equal installments on each anniversary
of the grant date until fully vested. Members of the Board who are also
employees or consultants of the Company receive no options for their services as
directors.
Employment
Contracts and Termination of Employment and Change of Control
Agreements
Daniel
Greenleaf
The
Company entered into a written employment agreement dated as of February 1, 2005
with Daniel Greenleaf, its newly-appointed President and Chief Executive
Officer. The agreement provides for a 3-year term and an initial annual base
salary of $360,000, plus a guaranteed annual bonus of $100,000 during each year
of the term of the agreement. In addition, Mr. Greenleaf is entitled to a
signing bonus in the amount of $50,000, of which one-half is payable following
the execution of the employment agreement and the remaining one-half is payable
on the 6-month anniversary of the agreement. Mr. Greenleaf is further entitled
to a “Discretionary Bonus” under the employment agreement of up to $250,000 per
year upon the attainment of certain performance criteria specified in the
employment agreement, and such other benefits generally made available to the
Company’s other senior management.
The
employment agreement also provides that Mr. Greenleaf is entitled to receive an
option to purchase 891,396 shares of the Company’s common stock, which
represents 5 percent of the Company’s currently outstanding common stock. The
option will vest in three equal annual installments, commencing February 2006.
In addition, until the Company has raised $20 million through the sale of equity
securities and has obtained the rights to one clinical stage human therapeutic,
Mr. Greenleaf shall be entitled to receive such additional options to purchase
common stock in order to maintain his beneficial ownership (assuming the
exercise of all stock options issued to Mr. Greenleaf) at 5 percent of the
Company’s outstanding common stock. To the extent any additional stock options
are issued pursuant to the foregoing sentence, the options will vest in
installments over the term of the employment agreement as long as Mr. Greenleaf
remains employed by the Company and will be exercisable at the market value of
the Company’s common stock at the time of issuance.
In the
event Mr. Greenleaf’s employment is terminated by the Company during the term
upon a “change of control” (as defined in the employment agreement) and on the
date of such termination the Company’s aggregate market capitalization is less
than $38 million, he is entitled to receive his base salary for six months
thereafter and all of his stock options scheduled to vest in the calendar year
of such termination shall accelerate and be deemed vested upon termination and
will remain exercisable for 12 months following such termination. In the event
the Company terminates Mr. Greenleaf’s employment during the term of the
agreement other than as a result of death, disability, cause or in connection
with a change of control where the Company’s aggregate market capitalization is
less than $38 million, then (i) Mr. Greenleaf is entitled to receive his base
salary for 12 months from such termination, his guaranteed bonus for the
calendar year in which such termination occurs, and the portion of any
discretionary bonus earned as of the termination, and (ii) the vesting of his
stock options shall accelerate and be deemed vested and will remain exercisable
for 12 months following such termination.
Ronald
Brandt
In April
2004, the Company appointed Ronald Brandt to be its President and Chief
Executive Officer on an interim basis. In June 2004, the Company appointed Mr.
Brandt to serve as President and Chief Executive Officer of its chiral ligand
operating subsidiary. In connection with that appointment, Mr. Brandt entered
into a new employment agreement with such subsidiary, which superseded his
October 2003 employment agreement with the Company. Mr. Brandt’s new employment
agreement provides for a term expiring in October 2006 and maintains his annual
base salary of $200,000. Mr. Brandt is also entitled to receive bonuses based on
the Company’s gross revenues, as follows:
(i) A one
time payment of $50,000 upon the completion of the first two consecutive fiscal
quarters in which the Company has gross revenue in excess of $1,000,000;
(ii) A
one time payment of $75,000 upon the completion of the first two consecutive
fiscal quarters in which the Company has gross revenue in excess of $2,500,000;
(iii) For
each fiscal quarter in which the Company has gross revenue in excess of
$2,500,000 following the first two consecutive fiscal quarters described in (ii)
above, the Company will remit to the Executive a payment of $10,000.
(iv) A
one time payment of $100,000 upon the completion of the first two consecutive
fiscal quarters in which the Company has gross revenue in excess of $5,000,000;
and
(v) For
each fiscal quarter in which the Company has gross revenue in excess of
$5,000,000 following the first two consecutive fiscal quarters described in (iv)
above, the Company will remit to the Executive a payment of $10,000 (in addition
to the $100,000 payment in (iv) above).
Mr.
Brandt is also entitled to a $100,000 bonus upon such time as the Company sells
the operating subsidiary for gross proceeds of at least $40
million.
In the
event Mr. Brandt’s employment is terminated by the Company upon a “change of
control” (as defined in the employment agreement), or for a reason other than
“disability” or “cause” (as those terms are defined in the employment
agreement), the Company has agreed to pay Mr. Brandt his base salary for 6
months, plus accrued bonuses, provided, that the Company’s obligation to
continue paying his base salary for a 6-month period will be reduced by the
amount Mr. Brandt earns from other employment during that period.
In
connection with his employment agreement, Mr. Brandt also received options to
purchase an aggregate of 400,000 shares of Company common stock at a fair market
value price at $1.01 per share (the fair market value at the date of grant). Of
such options, the right to purchase 100,000 shares vests in three equal annual
installments beginning June 2004. The right to purchase the remaining 300,000
shares vests as follows: (1) 100,000 shares vest at such time as the closing bid
price for the Company’s common stock exceeds $3.00 per share for 10 consecutive
trading days during the term of the employment agreement; (2) 100,000 shares
vest at such time as the closing bid price for the Company’s common stock
exceeds $5.00 per share for 10 consecutive trading days during the term of the
employment agreement; and 100,000 shares vest at such time as the closing bid
price for the Company’s common stock exceeds $7.00 per share for 10 consecutive
trading days during the term of the employment agreement. Mr. Brandt further
received an option to purchase 2.5% of the subsidiary’s common stock at a price
of $.01 per share, which will vest in 3 annual installments commencing June
2005.
ITEM
11. SECURITY
OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT
AND RELATED STOCKHOLDER MATTER
The
following table sets forth certain information regarding beneficial ownership of
the our common stock as of March 26, 2005, by (i) each person known by us to be
the beneficial owner of more than 5 percent of the outstanding common stock,
(ii) each director, (iii) each executive officer, and (iv) all executive
officers and directors as a group. Unless otherwise indicated, the address of
each of the following persons is 7 Deer Park Drive, Suite E, Monmouth Junction,
NJ 08852.
The
number of shares beneficially owned is determined under rules promulgated by the
SEC, and the information is not necessarily indicative of beneficial ownership
for any other purpose. Under those rules, beneficial ownership includes any
shares as to which the individual has sole or shared voting power or investment
power and also any shares which the individual has the right to acquire within
60 days of March 26, 2005, through the exercise or conversion of any stock
option, convertible security, warrant or other right. Including those shares in
the tables does not, however, constitute an admission that the named stockholder
is a direct or indirect beneficial owner of those shares. Unless otherwise
indicated, each person or entity named in the table has sole voting power and
investment power (or shares that power with that person’s spouse) with respect
to all shares of capital stock listed as owned by that person or
entity.
Name
and Address |
Number
of Shares
Beneficially
Owned (1) |
Percentage
of
Class |
Vincent
M. Aita, Ph.D. |
233,774 |
1.3% |
Kenneth
W. Brimmer |
154,300(2) |
* |
Stephen
C. Rocamboli |
106,999 |
* |
Stephen
A. Roth, Ph.D. |
50,000(3) |
* |
David
M. Tanen |
106,999 |
* |
Michael
Weiser, M.D., Ph.D. |
417,353 |
2.3% |
Daniel
Greenleaf |
20,000 |
* |
Brian
Lenz |
5,000 |
* |
Michael
Cannarsa |
0 |
* |
Ronald
Brandt |
58,333 |
* |
Xumu
Zhang, Ph.D. |
2,780,775 |
15.6% |
All
Executive Officers and Directors as a group
(8
persons) |
3,908,533 |
21.9% |
Lester
Lipschutz
1650
Arch Street - 22nd
Floor
Philadelphia,
PA 19103 |
1,915,534(4) |
10.7% |
Lindsay
A. Rosenwald, M.D.
787
Seventh Avenue, 48th
Floor
New
York, NY 10019 |
990,678(5) |
5.5% |
* Less than 1%.
(1)
Assumes
in each case that the shareholder exercised all options available to the person
that have vested or will vest within 60 days of March 26, 2005. Accordingly,
this table does not reflect: (i) options to purchase 12,900 shares of common
stock (at a price of $1.91 per share) that have been granted to each of Dr.
Aita, Mr. Brimmer, Mr. Rocamboli, Mr. Tanen, Dr. Weiser and Dr. Stephen Roth,
all of which vest in 3 equal annual installments commencing October 28, 2004;
(ii) 33,333 shares issuable upon exercise (at a price of $1.50 per share) of an
option granted to Dr. Stephen Roth, which shares vest in equal installments on
February 14, 2005 and February 14, 2006; and (iii) 487,539 shares issuable upon
exercise of an option held by Dr. Zhang, 487,539 of which vest on three equal
installments on each of May 15, 2005, May 15, 2006 and May 15, 2007.
(2)
Includes
7,500 shares which are owned by Mr. Brimmer’s Individual Retirement Account,
2,500 shares which are owned by the Individual Retirement Account of Mr.
Brimmer’s spouse (to which he disclaims any beneficial interest), and 100,000
vested options.
(3)
Represents
shares issuable upon exercise (at a price of $1.70 per share) of an option, a
portion of which vested February 14, 2004.
(4)
Based on
Schedule 13G filed with the SEC on December 17, 2004. Represents shares owned
equally by several trusts established for the benefit of Dr. Lindsay A.
Rosenwald or members of his immediate family, for which Mr. Lipschutz is the
trustee/investment manager, and over which he has voting control and investment
power.
(5)
Based on
a Schedule 13G filed February 11, 2005. Includes 102,871 shares issuable upon
the exercise of a warrant.
Equity
Compensation Plan Information
The
following table summarizes our outstanding options that we have issued to
certain officers, directors and employees of our company.
Plan
category |
|
Number
of securities to be issued upon exercise of outstanding options, warrants
and rights
(a) |
|
Weighted
average exercise price of outstanding options, warrants and
rights
(b) |
|
Number
of securities remaining available for future issuance (excluding
securities reflected in column (a))
(c) |
|
Equity
compensation plans approved by shareholders |
|
|
-- |
|
$ |
-- |
|
|
-- |
|
Equity
compensation plans not approved by stockholders (1) |
|
|
2,244,877 |
|
$ |
1.42 |
|
|
256,123 |
|
(1) |
Represent
shares of common stock issuable upon outstanding options issued to
employees and directors under our 2003 Stock Option Plan.
|
ITEM
12. CERTAIN
RELATIONSHIPS AND RELATED TRANSACTIONS
Dr.
Weiser and Mr. Rocamboli both of whom are directors of our company, are
employees of Paramount BioCapital, Inc. or its affiliates, a corporation of
which Dr. Lindsay A. Rosenwald is the chairman and sole shareholder. Dr.
Rosenwald beneficially owns approximately 5.5 percent of our outstanding common
stock and various trusts for the benefit of Dr. Rosenwald or members of his
immediate family beneficially own approximately 14 percent of our outstanding
common stock. Dr. Weiser and Mr. Rocamboli collectively own approximately 3
percent of our outstanding common stock. Paramount BioCapital participated as a
placement agent in connection with our February 2004 private placement, for
which it received aggregate commissions of approximately $300,000.
ITEM
13. EXHIBITS
Exhibit
No.
|
Description
|
2.1
|
Merger
Agreement dated November 12, 2002, by and among the Registrant, CQ
Acquisition, Inc. and Chiral Quest, LLC (incorporated by reference to
Exhibit 2.1 to the Registrant’s Form 8-K filed November 27,
2002).
|
3.1
|
Articles
of Incorporation, as amended to date (incorporated by reference to Exhibit
3.1 of Registrant’s Annual Report in Form 10-KSB for the year ended
December 31, 2004).
|
3.2
|
Bylaws,
as amended to date (incorporated by reference to Exhibit 3.2 of
Registrant’s Annual Report on Form 10-KSB for the year ended December 31,
2003).
|
4.1
|
Common
Stock Purchase Warrant dated as of February 18, 2003 issued to Key West
Associates, LLC (incorporated by reference to Exhibit 4.1 to the
Registrant’s Form 10-QSB for the period ended March 31,
2003).
|
4.2
|
Option
Agreement No. LL-1 dated May 6,
2003
issued to Princeton Corporate Plaza, LLC. (incorporated by reference to
Exhibit 4.1 to the Registrant’s Form 10-QSB for the period ended June 30,
2003).
|
4.3
|
Form
of Option Agreement dated May 6,
2003
issued to Princeton Corporate Plaza, LLC (incorporated by reference to
Exhibit 4.2 to the Registrant’s Form 10-QSB for the period ended June 30,
2003).
|
4.4
|
Schedule
of Options substantially identical to Exhibit 4.3 (incorporated by
reference to Exhibit 4.3 to the Registrant’s Form 10-QSB for the period
ended June 30, 2003).
|
4.5
|
Form
of Common Stock Purchase Warrant issued in connection with February 2004
private placement (incorporated by reference to the Registrant’s Form SB-2
filed March 26, 2004 (File No. 333-113980)).
|
10.1
|
License
Agreement dated on or about October 27, 2000, as amended, between Chiral
Quest, LLC and The Penn State Research Foundation (incorporated by
reference to Exhibit 10.2 to the Registrant’s Form 10-QSB for the period
ended March 31, 2003).
|
10.2
|
Consulting
Agreement dated May 15, 2003 between the Registrant and Xumu Zhang, Ph.D.
(incorporated by reference to Exhibit 10.1 to the Registrant’s Form 10-QSB
for the period ended June 30, 2003).
|
10.3
|
2003
Stock Option Plan (incorporated by reference to Exhibit 10.4 to the
Registrant’s Form 10-KSB for the year ended December 31,
2003).
|
10.4
|
Separation
Agreement dated April 2, 2004 between the Registrant and Alan D. Roth
(incorporated by reference to Exhibit 10.1 to the Registrant’s Form 8-K
filed on April 19, 2004).
|
10.5
|
Employment
Agreement dated October 6, 2003 between the Company and Ronald Brandt
(incorporated by reference to Exhibit 10.1 to the Registrant’s Form 10-QSB
for the period ended June 30, 2004).
|
10.6
|
Employment
Agreement dated February 1, 2005 between the Company and Daniel
Greenleaf.
|
16.1
|
Letter
regarding change in independent accountants (incorporated by reference to
Exhibit 16.1 to the Registrant’s Form 8-K/A filed January 5,
2004).
|
16.2
|
Letter
regarding change in independent accountants (incorporated by reference to
Exhibit 16.1 to the Registrant’s Form 8-K filed April 25,
2003).
|
31.1
|
Certification
of Chief Executive Officer
|
31.2
|
Certification
of Chief Financial Officer.
|
32.1
|
Certification
pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|
ITEM
14. PRINCIPAL ACCOUNTANT FEES AND
SERVICES.
Fees
Billed to the Company by Its Independent Registered Public Accounting
Firm
The
following is a summary of the fees billed to us by J.H. Cohn LLP, our current
independent registered public accounting firm, for professional services
rendered for fiscal years ended December 31, 2004 and December 31, 2003 and by
Weinberg & Company, P.A., our former independent registered public
accounting firm, for professional services rendered during the fiscal year ended
December 31, 2003:
|
|
J.H.
Cohn LLP |
|
J.H.
Cohn LLP |
|
Weinberg
& Company, P.A. |
|
Fee
Category |
|
Fiscal
2004 Fees |
|
Fiscal
2003 Fees |
|
Fiscal
2003 Fees |
|
|
|
|
|
|
|
|
|
Audit
Fees (1) |
|
$ |
102,512 |
|
$ |
10,000 |
|
$ |
1,000 |
|
Audit-Related
Fees (2) |
|
$ |
4,966 |
|
|
|
|
$ |
19,000 |
|
Tax
Fees (3) |
|
$ |
20,310 |
|
|
|
|
|
|
|
All
Other Fees (4) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
Fees |
|
$ |
127,788 |
|
$ |
10,000 |
|
$ |
20,000 |
|
(1)
Audit
fees consist principally of fees for services in connection with the audit of
the Company’s annual financial statements and reviews of its financial
statements.
(2)
Audit-Related Fees consist principally of assurance and related services that
are reasonably related to the performance of the audit or review of the
Company’s financial statements but not reported under the caption “Audit Fees.”
These fees include review of registration statements and participation at board
of director and audit committee meetings. The Company’s Audit-Related Fees
primarily consist of the fees associated with the Company’s SB-2 Filing as a
result of the February 2004 Private Placement of its common stock.
(3)
Tax Fees
consist of fees for tax compliance, tax advice and tax planning.
(4)
All Other
Fees consist of aggregate fees billed for products and services provided by the
independent registered public accounting firm, other than those disclosed above.
These fees include services related to certain accounting research and
assistance with a regulatory matter.
Policy
on Audit Committee Pre-Approval of Audit and Permissible Non-Audit Services of
Independent Auditors
At
present, our audit committee approves each engagement for audit or non-audit
services before we engage our independent registered public accounting firm to
provide those services. Our audit committee has not established any pre-approval
policies or procedures that would allow our management to engage our independent
registered public accounting firm to provide any specified services with only an
obligation to notify the audit committee of the engagement for those services.
None of the services provided by our independent registered public accounting
firm for fiscal 2004 was obtained in reliance on the waiver of the pre-approval
requirement afforded in SEC regulations.
SIGNATURES
In
accordance with Section 13 or 15(d) of the Securities Exchange Act, VioQuest
Pharmaceuticals, Inc. has duly caused this report to be signed on its behalf by
the undersigned, thereunto duly authorized, on March 30, 2005.
|
|
|
|
VioQuest
Pharamceuticals, Inc. |
|
|
|
|
By: |
/s/ Daniel Greenleaf |
|
Daniel Greenleaf |
|
President & Chief Executive
Officer |
In
accordance with the Securities Exchange Act, this report has been signed below
by the following persons on behalf of VioQuest Pharmaceuticals, Inc. and in the
capacities and on the dates indicated.
Signature |
|
Title |
|
Date |
|
|
|
|
|
/s/
Daniel
Greenleaf |
|
|
|
|
Daniel
Greenleaf |
|
President
& Chief Executive Officer and Director |
|
March
30, 2005 |
|
|
|
|
|
/s/ Brian Lenz |
|
|
|
|
Brian
Lenz |
|
Chief
Financial Officer and Secretary |
|
March
30, 2005 |
|
|
|
|
|
/s/ Vincent M. Aita |
|
|
|
|
Vincent
M. Aita |
|
Director |
|
March
29, 2005 |
|
|
|
|
|
|
|
|
|
|
Ronald
Brandt |
|
Director |
|
March
__, 2005 |
|
|
|
|
|
/s/ Kenneth
W. Brimmer |
|
|
|
|
Kenneth
W. Brimmer |
|
Director |
|
March
30, 2005 |
|
|
|
|
|
/s/ Stephen
C. Rocamboli |
|
|
|
|
Stephen
C. Rocamboli |
|
Director |
|
March
30, 2005 |
|
|
|
|
|
/s/ Stephen
A. Roth |
|
|
|
|
Stephen
A. Roth |
|
Director |
|
March
29, 2005 |
|
|
|
|
|
/s/ David
M. Tanen |
|
|
|
|
David
M. Tanen |
|
Director |
|
March
29, 2005 |
|
|
|
|
|
/s/ Michael
Weiser |
|
|
|
|
Michael
Weiser |
|
Director |
|
March
29, 2005 |
|
|
|
|
|
/s/ Xumu
Zhang |
|
|
|
|
Xumu
Zhang |
|
Director |
|
March
30, 2005 |
Index
to Consolidated Financial Statements
|
Page |
Report
of J.H. Cohn LLP
|
F-2
|
Consolidated
Balance Sheets as of December 31, 2004 and 2003
|
F-3
|
Consolidated
Statements of Operations for the Years Ended December 31, 2004 and
2003
|
F-4
|
Consolidated
Statements of Changes in Stockholders’ Equity (Deficiency) for the Years
Ended December
31, 2004 and 2003 |
F-5
|
Consolidated
Statements of Cash Flows for the Years Ended December 31, 2004 and
2003
|
F-6 |
Notes
to Consolidated Financial Statements
|
F-7
to F-20
|
Report
of Independent Registered Public Accounting Firm
To the
Board of Directors and Stockholders
VioQuest
Pharmaceuticals, Inc.
We have
audited the accompanying consolidated balance sheets of VioQuest
Pharmaceuticals, Inc. and Subsidiaries as of December 31, 2004 and 2003, and the
related consolidated statements of operations, changes in stockholders' equity
(deficiency) and cash flows for the years then ended. These consolidated
financial statements are the responsibility of the Company's management. Our
responsibility is to express an opinion on these consolidated financial
statements based on our 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 audit to obtain reasonable assurance about whether the financial
statements are free of material misstatement. An audit includes examining, on a
test basis, evidence supporting the amounts and disclosures in the financial
statements. An audit also includes assessing the accounting principles used and
significant estimates made by management, as well as evaluating the overall
financial statement presentation. We believe that our audits provide a
reasonable basis for our opinion.
In our
opinion, the consolidated financial statements referred to above present fairly,
in all material respects, the consolidated financial position of VioQuest
Pharmaceuticals, Inc. and Subsidiaries as of December 31, 2004 and 2003, and
their results of operations and cash flows for the years then ended, in
conformity with accounting principles generally accepted in the United States of
America.
The
accompanying consolidated financial statements have been prepared assuming that
the Company will continue as a going concern. As discussed in Note 1 to the
consolidated financial statements, the Company incurred a net loss of $4,023,558
and used $3,786,173 of cash in operating activities during the year ended
December 31, 2004 and, as of that date, it had an accumulated deficit of
$7,434,763. These matters raise substantial doubt about the Company's ability to
continue as a going concern. Management's plans concerning these matters are
also described in Note 1. The consolidated financial statements do not include
any adjustments that might result from the outcome of this
uncertainty.
/s/J.H.
Cohn LLP
Roseland,
New Jersey
February
19, 2005
VIOQUEST
PHARMACEUTICALS, INC. AND SUBSIDIARIES
CONSOLIDATED
BALANCE SHEETS
AS
OF DECEMBER 31, 2004 AND 2003
|
|
2004 |
|
2003 |
|
ASSETS |
CURRENT
ASSETS |
|
|
|
|
|
Cash
and cash equivalents |
|
$ |
3,065,547 |
|
$ |
659,117 |
|
Accounts
receivable, net of allowance for doubtful accounts of $11,490 at December
31, 2003 |
|
|
318,585 |
|
|
51,705 |
|
Inventory |
|
|
360,147 |
|
|
76,892 |
|
Other
current assets |
|
|
64,377 |
|
|
50,052 |
|
|
|
|
|
|
|
|
|
Total
Current Assets |
|
|
3,808,656 |
|
|
837,766
|
|
|
|
|
|
|
|
|
|
PROPERTY
AND EQUIPMENT, NET |
|
|
493,632 |
|
|
254,649 |
|
|
|
|
|
|
|
|
|
SECURITY
DEPOSITS |
|
|
31,000 |
|
|
31,000 |
|
DEFERRED
FINANCING COSTS |
|
|
- |
|
|
50,000 |
|
|
|
|
|
|
|
|
|
INTELLECTUAL
PROPERTY RIGHTS, NET |
|
|
543,453 |
|
|
412,442 |
|
|
|
|
|
|
|
|
|
TOTAL
ASSETS |
|
$ |
4,876,741 |
|
$ |
1,585,857 |
|
|
|
|
|
|
|
|
|
LIABILITIES
AND STOCKHOLDERS' EQUITY |
CURRENT
LIABILITIES |
|
|
|
|
|
|
|
Accounts
payable |
|
$ |
303,392 |
|
$ |
273,414 |
|
Accrued
expenses |
|
|
219,715 |
|
|
226,200 |
|
Due
to related party |
|
|
- |
|
|
1,201 |
|
Deferred
revenue, current portion |
|
|
563,842 |
|
|
220,592
|
|
Total
Current Liabilities |
|
|
1,086,949 |
|
|
721,407 |
|
|
|
|
|
|
|
|
|
LONG-TERM
LIABILITIES |
|
|
|
|
|
|
|
Deferred
revenue, long-term portion |
|
|
- |
|
|
39,116 |
|
|
|
|
|
|
|
|
|
TOTAL
LIABILITIES |
|
|
1,086,949 |
|
|
760,523 |
|
|
|
|
|
|
|
|
|
COMMITMENTS
AND CONTINGENCIES |
|
|
|
|
|
|
|
STOCKHOLDERS'
EQUITY |
|
|
|
|
|
|
|
Common
stock, $.01 par value, 50,000,000 shares authorized, 17,827,924 shares
issued and outstanding at December 31, 2004, and 13,001,018 shares issued
and outstanding at December 31, 2003 |
|
|
178,279 |
|
|
130,010 |
|
Additional
paid-in capital |
|
|
11,508,715 |
|
|
4,865,353 |
|
Deferred
consulting expenses |
|
|
(462,439 |
) |
|
(758,824 |
) |
Accumulated
consulting deficit |
|
|
(7,434,763 |
) |
|
(3,411,205 |
) |
Total
Stockholders' Equity |
|
|
3,789,792 |
|
|
825,334 |
|
|
|
|
|
|
|
|
|
TOTAL
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
$ |
4,876,741 |
|
$ |
1,585,857 |
|
|
|
|
|
|
|
|
|
See accompanying notes to consolidated financial
statements.
VIOQUEST
PHARAMCEUTICALS, INC. AND SUBSIDIARIES
CONSOLIDATED
STATEMENTS OF OPERATIONS
FOR
THE YEARS ENDED DECEMBER 31, 2004 AND 2003
|
|
2004 |
|
2003 |
|
|
|
|
|
|
|
REVENUE |
|
$ |
1,485,148 |
|
$ |
669,036 |
|
|
|
|
|
|
|
|
|
COST
OF GOODS SOLD (Excluding
Depreciation) |
|
|
837,653 |
|
|
196,045 |
|
|
|
|
|
|
|
|
|
GROSS
PROFIT |
|
|
647,495 |
|
|
472,991 |
|
|
|
|
|
|
|
|
|
OPERATING
EXPENSES |
|
|
|
|
|
|
|
Management
and consulting expenses |
|
|
626,709 |
|
|
361,622 |
|
Research
and development |
|
|
902,162 |
|
|
440,646 |
|
Selling,
general and administrative |
|
|
1,612,021 |
|
|
1,012,182 |
|
Compensation |
|
|
1,389,399 |
|
|
601,780 |
|
Depreciation
and amortization |
|
|
179,034 |
|
|
86,325 |
|
Total
Operating Expenses |
|
|
4,709,325 |
|
|
2,502,555 |
|
|
|
|
|
|
|
|
|
LOSS
FROM OPERATIONS |
|
|
(4,061,830 |
) |
|
(2,029,564 |
) |
|
|
|
|
|
|
|
|
INTEREST
EXPENSE |
|
|
- |
|
|
(2,809 |
) |
|
|
|
|
|
|
|
|
INTEREST
INCOME |
|
|
38,272 |
|
|
13,973 |
|
|
|
|
|
|
|
|
|
NET
LOSS |
|
$ |
(4,023,558 |
) |
$ |
(2,018,400 |
) |
|
|
|
|
|
|
|
|
NET
LOSS PER COMMON SHARE – BASIC AND
DILUTED |
|
$ |
(.24 |
) |
$ |
(.16 |
) |
|
|
|
|
|
|
|
|
WEIGHTED
AVERAGE SHARES OUTSTANDING – BASIC AND
DILUTED |
|
|
17,100,582 |
|
|
12,476,789 |
|
See accompanying notes to consolidated financial
statements.
VIOQUEST
PHARMACEUTICALS, INC. AND SUBSIDIARIES
CONSOLIDATED
STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY (DEFICIENCY)
FOR
THE YEARS ENDED DECEMBER 31, 2004 and 2003
|
|
Equity
Units |
|
|
|
Common
Stock |
|
|
|
|
|
|
|
|
|
|
|
Units |
|
Amount |
|
Additional
Members' Equity |
|
Shares |
|
Amount |
|
Additional
Paid-In Capital |
|
Deferred
Consulting Expenses |
|
Accumulated
Deficit |
|
Total
Equity (Deficiency) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance,
January 1, 2003 |
|
|
11,500,000
|
|
$ |
1,213,000 |
|
$ |
135,050 |
|
|
-
|
|
$ |
- |
|
$ |
- |
|
$ |
(356,400 |
) |
$ |
(1,392,805 |
) |
$ |
(401,155 |
) |
Conversion
of Chiral Quest LLC member units to common stock at 2/18/03 at a rate of
.752374 share per unit (See Note 1 (B)) |
|
|
(11,500,000 |
) |
|
(1,213,000 |
) |
|
(135,050 |
) |
|
8,652,298
|
|
|
86,523
|
|
|
1,261,527
|
|
|
|
|
|
|
|
|
-
|
|
Recapitalization
of the Company (See Note 1(B)) |
|
|
|
|
|
|
|
|
|
|
|
4,348,720
|
|
|
43,487
|
|
|
2,964,211
|
|
|
|
|
|
|
|
|
3,007,698
|
|
Options
issued for services and rent |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
639,615
|
|
|
(639,615 |
) |
|
|
|
|
-
|
|
Amortization
of deferred consulting expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
237,191
|
|
|
|
|
|
237,191
|
|
Net
loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(2,018,400 |
) |
|
(2,018,400 |
) |
Balance,
December 31, 2003 |
|
|
- |
|
|
- |
|
|
- |
|
|
13,001,018
|
|
|
130,010
|
|
|
4,865,353
|
|
|
(758,824 |
) |
|
(3,411,205 |
) |
|
825,334
|
|
February
25, 2004 Private Placement, net of costs |
|
|
|
|
|
|
|
|
|
|
|
4,826,906
|
|
|
48,269
|
|
|
6,643,362
|
|
|
|
|
|
|
|
|
6,691,631
|
|
Amortization
of deferred consulting expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
296,385
|
|
|
|
|
|
296,385
|
|
Net
loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(4,023,558 |
) |
|
(4,023,558 |
) |
Balance,
December 31, 2004 |
|
|
- |
|
|
- |
|
|
- |
|
|
17,827,924
|
|
$ |
178,279 |
|
$ |
11,508,715 |
|
$ |
(462,439 |
) |
$ |
(7,434,763 |
) |
$ |
3,789,792 |
|
See accompanying notes to consolidated financial
statements.
VIOQUEST
PHARMACEUTICALS, INC. AND SUBSIDIARIES
CONSOLIDATED
STATEMENTS OF CASH FLOWS
FOR
THE YEARS ENDED DECEMBER 31, 2004 AND 2003
|
|
2004 |
|
2003 |
|
CASH
FLOWS FROM OPERATING ACTIVITIES: |
|
|
|
|
|
Net
loss |
|
$ |
(4,023,558 |
) |
$ |
(2,018,400 |
) |
Adjustments
to reconcile net loss to net cash used in operating
activities: |
|
|
|
|
|
|
|
Depreciation
and amortization |
|
|
179,034 |
|
|
86,325 |
|
Amortization
of deferred consulting expenses |
|
|
296,385 |
|
|
237,191 |
|
Changes
in operating assets and liabilities: |
|
|
|
|
|
|
|
Increase
in accounts receivable |
|
|
(266,880 |
) |
|
(39,249 |
) |
Increase
in inventory |
|
|
(283,255 |
) |
|
(48,470 |
) |
Increase
in other current assets |
|
|
(14,325 |
) |
|
(50,052 |
) |
Increase
in security deposits |
|
|
- |
|
|
(31,000 |
) |
Increase
in accounts payable |
|
|
29,978 |
|
|
161,582 |
|
Increase
(decrease) in accrued expenses and due to related party |
|
|
(7,686 |
) |
|
112,481 |
|
Increase
(decrease) in deferred revenue |
|
|
304,134 |
|
|
(47,342 |
) |
Net
Cash Used In Operating Activities |
|
|
(3,786,173 |
) |
|
(1,636,934 |
) |
|
|
|
|
|
|
|
|
CASH
FLOWS FROM INVESTING ACTIVITIES: |
|
|
|
|
|
|
|
Payments
for purchased property and equipment |
|
|
(356,548 |
) |
|
(237,222 |
) |
Payments
for intellectual property rights |
|
|
(192,481 |
) |
|
(130,865 |
) |
Net
Cash Used In Investing Activities |
|
|
(549,029 |
) |
|
(368,087 |
) |
|
|
|
|
|
|
|
|
CASH
FLOWS FROM FINANCING ACTIVITIES: |
|
|
|
|
|
|
|
Proceeds
from notes payable |
|
|
- |
|
|
40,000 |
|
Payment
of note payable |
|
|
- |
|
|
(376,625 |
) |
Cash
received in merger and recapitalization |
|
|
- |
|
|
3,017,243 |
|
Cash
received in private placement of common stock |
|
|
6,741,632 |
|
|
- |
|
Payments
for deferred financing costs |
|
|
- |
|
|
(50,000 |
) |
Net
Cash Provided By Financing Activities |
|
|
6,741,632 |
|
|
2,630,618 |
|
|
|
|
|
|
|
|
|
NET
INCREASE IN CASH AND CASH EQUIVALENTS |
|
|
2,406,430 |
|
|
625,597 |
|
|
|
|
|
|
|
|
|
CASH
AND CASH EQUIVALENTS - BEGINNING OF YEAR |
|
|
659,117 |
|
|
33,520 |
|
|
|
|
|
|
|
|
|
CASH
AND CASH EQUIVALENTS - END OF YEAR |
|
$ |
3,065,547 |
|
$ |
659,117 |
|
|
|
|
|
|
|
|
|
Supplemental
Schedule of Non-Cash Investing and Financing
Activities: |
|
|
|
|
|
|
|
Reclassification
of deferred financing costs to additional paid-in capital in connection
with private placement |
|
$ |
50,000 |
|
$ |
- |
|
See accompanying notes to consolidated financial
statements.
VIOQUEST
PHARMACEUTICALS, INC. AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER
31, 2004 AND 2003
NOTE 1 SUMMARY
OF SIGNIFICANT ACCOUNTING POLICIES AND NATURE OF
OPERATIONS
(A)
Nature of Operations and Liquidity
Since its
inception in October 2000, VioQuest Pharmaceuticals, Inc. (formerly Chiral
Quest, Inc.) has provided pharmaceutical and fine chemical companies in all
stages of the product lifecycles with innovative chiral products and services
(as used herein, the “Company” refers to VioQuest Pharmaceuticals, Inc. or
VioQuest Pharmaceuticals, Inc. together with its subsidiaries). Since August
2004, the Company has provided such products and services through its
wholly-owned subsidiary, Chiral Quest, Inc. Chiral Quest, Inc. develops chemical
catalysts used in the synthesis of desired isomers of chiral molecules using
asymmetrical catalysis technology (the “Technology”) owned by the
Pennsylvania State University Research Foundation (“PSRF”), the technology arm
of The Pennsylvania State University (“Penn State”). Chiral Quest, Inc. has a
worldwide, exclusive license from PSRF for the inventions covered by the
license. The original license agreement was entered into on November 8, 2000
(See Note 5).
In August
2004, the Company formed VioQuest Drug Development, Inc., a wholly-owned
subsidiary, which will focus on acquiring and bringing to market therapies for
oncology, metabolic and inflammatory diseases and disorders that are current
unmet medical needs. To date, VioQuest Drug Development, Inc. has not yet
acquired any product candidates, has not realized any revenue and has not
incurred any expenses.
From the
Company’s inception through December 31, 2004, it has generated sales revenue
but not any net profits. Management believes that the Company’s research and
development (“R&D”) and manufacturing capacity will need to grow in order
for the Company to be able to obtain significant licensing and manufacturing
agreements with large fine chemical and pharmaceutical companies. Management
believes that the Company’s manufacturing capacity will be enhanced with its
expanded office and laboratory space located in Monmouth Junction, New Jersey
that was leased in May 2003, in addition to the leased space located in Jiashan,
China.
The
accompanying consolidated financial statements have been prepared assuming that
the Company will continue as a going concern. Since inception the Company has
incurred a cumulative deficit of $7,434,763 through December 31, 2004. For the
year ended December 31, 2004 the Company had a net loss of $4,023,558. These
matters raise doubt about its ability to continue as a going concern. Management
expects the Company’s losses to increase over the next several years, primarily
due to expansion of its research and development programs, the hiring of
additional chemists, the expansion of its manufacturing capabilities, and the
costs related to acquiring a drug candidate. There can be no assurance that the
Company will ever be able to operate profitably.
As of
December 31, 2004, the Company had working capital of $2,721,707 and cash and
cash equivalents of $3,065,547. Unless the Company is able to significantly
increase its revenues, it will most likely require additional financing by the
end of the second quarter of 2005 in order to continue operations. The most
likely sources of financing include private placements of the Company’s equity
or debt securities or bridge loans to the Company from third party
lenders.
The
Company’s net cash used in operating activities for the year ended 2004 was
$3,786,173. The Company’s net loss of $4,023,558 was offset by amortization of
deferred expenses of $296,385, deferred revenue of $304,134, and depreciation
and amortization of $179,034. Operating activities also included increases in
accounts receivable of $266,880 and inventory of $283,255.
VIOQUEST
PHARMACEUTICALS, INC. AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER
31, 2004 AND 2003
The
Company’s net cash used in investing activities for the year ended 2004 was
$549,029. Investing activities expenditures consisted of purchases of property
and equipment of $356,548 which was attributed to the laboratory expansions
during the second and third quarters of 2004 and payments for increased patent
filings of intellectual property rights of $192,481.
The
Company’s net cash provided by financing activities for the year ended 2004 was
$6,741,632. Financing activities consisted of cash received as a result of the
private placement of the Company’s common stock in February 2004.
The
Company’s capital requirements will depend on numerous factors, including:
competing technological and market developments, changes in our existing
collaborative relationships, the cost of filing, prosecuting, defending and
enforcing patent claims and other intellectual property rights and the outcome
if any potentially related litigation or other dispute, the purchase of
additional capital equipment, acquisition of technologies, the establishment and
funding of the Chiral Quest, Jiashan, China facility, and the development and
regulatory approval progress of its customers’ product candidates into which the
Company’s technology will be incorporated, in addition to the costs associated
with the drug development process related to acquiring a drug candidate.
Additional
capital that may be needed by the Company in the future may not be available on
reasonable terms, or at all. If adequate financing is not available, the Company
may be required to terminate or significantly curtail its operations, or enter
into arrangements with collaborative partners or others that may require the
Company to relinquish rights to certain of its technologies, or potential
markets that the Company would not otherwise relinquish.
The
Company’s ability to achieve profitability depends upon, among other things, its
ability to discover and develop products (specifically new “ligands”), and to
develop its products on a commercial scale through a cost effective and
efficient process. To the extent that the Company is unable to produce, directly
or indirectly, ligands in quantities required for commercial use, it will not
realize any significant revenues from its technology. Moreover, there can be no
assurance that it will ever achieve significant revenues or profitable
operations from the sale of any of its products or technologies.
(B)
Merger
On
February 18, 2003, Chiral Quest, LLC merged (the “Merger”) with and into CQ
Acquisition, Inc., a wholly owned subsidiary of Surg II, Inc. (“Surg”), a
reporting public corporation with no current operations. Each member equity unit
of Chiral Quest, LLC issued and outstanding on February 18, 2003 (“Effective
Date”) was automatically converted into 0.752374 shares of Surg common stock.
There were 4,348,720 shares of Surg common stock issued and outstanding and
options to purchase an additional 682,875 shares immediately prior to the
Effective Date. At the Effective Date, Chiral Quest, LLC had 11,500,000 member
equity units outstanding. Accordingly, as a result of the Merger, Surg issued
8,652,298 shares of its common stock to the former members of Chiral Quest, LLC.
In addition, immediately prior to the Effective Date, there were non-vested
contingent options and warrants outstanding to purchase an aggregate of up to
1,210,000 of Chiral Quest LLC’s member equity units, which following the Merger
represented the right to purchase an aggregate of up to 910,374 shares of Surg
common stock at $1.49 per share. In connection with the Merger, Surg changed its
name to Chiral Quest, Inc. In August 2004, Chiral Quest, Inc. changed its name
to VioQuest Pharmaceuticals, Inc. and renamed CQ Acquisition, Inc. as Chiral
Quest, Inc. Subsequent to the Effective Date, the Company has reported its
results of operations on a consolidated basis.
VIOQUEST
PHARMACEUTICALS, INC. AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER
31, 2004 AND 2003
Generally
accepted accounting principles in the United States of America require that the
company whose equity holders retain a majority interest in a business
combination, maintain the majority of board memberships and hold key management
positions to be treated as the acquiror for accounting purposes. Since,
following upon completion of the Merger, the former members of Chiral Quest, LLC
held approximately two-thirds of the outstanding common stock of the Company,
designees of Chiral Quest LLC comprised the majority of the Company’s Board of
Directors, and the officers of Chiral Quest, LLC immediately prior to the Merger
were appointed the officers of the Company, the merger was accounted for as a
reverse acquisition with Chiral Quest, LLC as the accounting acquirer (legal
acquiree) and Surg II as the accounting acquiree (legal acquirer).
If the
Merger between Surg II and Chiral Quest, Inc. had occurred as of January 1, 2003
unuaudited pro forma revenues, net loss and net loss per share would have been
as illustrated in the following table for the year ended December 31, 2003:
|
|
Pro
Forma (Unaudited) |
|
|
|
Year
Ended |
|
|
|
December
31, 2003 |
|
REVENUES |
|
$ |
669,036 |
|
NET
LOSS |
|
$ |
(2,074,531 |
) |
BASIC
AND DILUTED LOSS PER COMMON SHARE |
|
$ |
(0.16 |
) |
WEIGHTED
AVERAGE COMMON SHARES OUTSTANDING - BASIC AND DILUTED |
|
|
13,001,018
|
|
The above
pro forma financial information is not necessarily indicative of what the
Company’s results of operations would have been had the Merger occurred on
January 1, 2003.
(C)
Principles of Consolidation
The
accompanying consolidated financial statements include the accounts of VioQuest
Pharmaceuticals, Inc. and its subsidiaries. All significant intercompany
accounts and transactions have been eliminated in consolidation.
(D)
Cash and Cash Equivalents
The
Company considers all highly-liquid investments with an original maturity of
three months or less when acquired to be cash equivalents.
VIOQUEST
PHARMACEUTICALS, INC. AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER
31, 2004 AND 2003
(E)
Fair Value of Financial Instruments
The
carrying value of financial instruments including cash and cash equivalents,
accounts receivable, and accounts payable approximate fair value due to the
relatively short maturity of these instruments. The carrying value of the note
payable approximates fair value based on the incremental borrowing rates
currently available to the Company for financing with similar terms and
maturities.
(F)
Allowance for Doubtful Accounts
The
Company establishes an allowance for uncollectible accounts receivable, when
appropriate, based on historical collection experience and management’s
evaluation of collectibility of outstanding accounts receivable.
(G)
Inventory
Inventory
consists of raw materials, work in process and finished goods which are stated
at the lower of cost (first-in, first-out) or market. Raw materials consist of
chemical compounds. Work in process and finished goods, referred to as
proprietary ligands, consist of material, direct labor and manufacturing
overhead.
(H)
Property and Equipment
Property
and equipment is recorded at cost and depreciated over the estimated useful
lives of the assets, principally using the straight-line method. For tax
purposes, accelerated methods are used. The estimated useful lives used for
depreciation and amortization were three, five and seven years for leasehold
improvements, laboratory/computer equipment and office equipment, respectively
(See Note 3).
(I)
Intellectual Property Rights
Intellectual
property rights are being amortized over the lives of the underlying patents,
which generally are 17 years. Amortization expense recorded for the years ended
December 31, 2004 and 2003 was $61,471 and $36,792, respectively. Accumulated
amortization as of December 31, 2004 and December 31, 2003 was $112,131 and
$50,660, respectively. Amortization expense for each of the five years
subsequent to the year ended December 31, 2004, is approximately $39,000 per
year.
(J)
Revenue Recognition
Revenues
are comprised principally of four main components: (1) the licensing of PSRF’s
Technology, (2) the sale of proprietary ligands, (3) feasibility screening, and
(4) custom contract development. Revenues as they relate to the licensing of the
Company's rights to PSRF's intellectual property are recognized over the
applicable license periods. The Company assumes the financial risks related to
these revenues by financing the research and development of PSRF's technology as
well as the defense of PSRF's patents. Deferred revenue in the accompanying
consolidated balance sheets represents amounts prepaid by customers to the
Company for services to be performed and products to be delivered at a
subsequent date. These deferred and unearned amounts will be recognized as
revenue when earned. Revenues as they relate to the sale of manufactured
proprietary ligands are recognized upon the shipment of the ligands to the
customer. Revenues as they relate to feasibility screening are recognized upon
the completion of project reports and investigational studies. Revenues as they
relate to custom contract development are recognized upon the shipment of
finished products. However, revenue is not recognized unless collectibility is
reasonably assured.
VIOQUEST
PHARMACEUTICALS, INC. AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER
31, 2004 AND 2003
(K)
Income Taxes
Under
Statement of Financial Accounting Standards No. 109, “Accounting for Income
Taxes,” (“SFAS 109”) deferred tax assets and liabilities are recognized for the
future tax consequences attributable to temporary differences between the
financial statement carrying amounts of existing assets and liabilities and
their respective tax bases. Deferred tax assets and liabilities are measured
using enacted tax rates expected to apply to taxable income in the years in
which those temporary differences are expected to be recovered or settled. Under
SFAS 109, the effect on deferred tax assets and liabilities of a change in tax
rates is recognized in income in the period that includes the enactment date.
Valuation allowances are established when it is more likely than not that
deferred tax assets will not be realized.
(L)
Stock-Based Compensation
The
Company accounts for its employee and director stock option plans using the
intrinsic value method in accordance with APB Opinion No. 25, “Accounting For
Stock Issued To Employees,” and related interpretations. The Company measures
compensation expense for employee and director stock options as the aggregate
difference, if any, between the market value of its common stock and exercise
prices of the options on the date that both the number of shares the grantee is
entitled to receive and the exercise prices are known. However, the Company has
not recorded any expense for employee options since they were granted at market
value. If the Company had elected to recognize compensation cost for all
outstanding options granted by the Company to employees by applying the fair
value recognition provisions of SFAS 123 “Accounting for Stock Based
Compensation” to employee stock options, and amortizing the fair value over the
vesting period, net loss and loss per share for the years ended December 31,
2004 and 2003, would have been increased to the pro forma amounts indicated
below:
|
|
Year
Ended |
|
Year
Ended |
|
|
|
December
31, 2004 |
|
December
31, 2003 |
|
Net
loss as reported |
|
$ |
(4,023,558 |
) |
$ |
(2,018,400 |
) |
Less:
Total stock-based employee compensation expense using the fair value based
method for all awards, net of related tax effects |
|
|
(315,003 |
) |
|
(165,272 |
) |
Pro
forma net loss |
|
$ |
(4,338,561 |
) |
$ |
(2,183,672 |
) |
Basic
and diluted net loss per common share: |
|
|
|
|
|
|
|
As
reported |
|
$ |
(0.24 |
) |
$ |
(0.16 |
) |
Pro
forma net loss |
|
$ |
(0.25 |
) |
$ |
(0.18 |
) |
VIOQUEST
PHARMACEUTICALS, INC. AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER
31, 2004 AND 2003
For pro
forma disclosure purposes and for the purpose of valuing options granted to
non-employees, the Company has valued the options using the Black-Scholes option
pricing model with the following assumptions used in 2004 and 2003:
|
|
December
31, 2004 |
|
December
31, 2003 |
|
Risk-free
interest rate |
|
3%-5% |
|
2.3%-4% |
|
Volatility |
|
39%-98% |
|
64%-127% |
|
Lives
in years |
|
10 |
|
10 |
|
Dividend
yield |
|
0% |
|
0% |
|
As a
result of amendments to SFAS 123, the Company will be required to expense the
fair value of employee stock options beginning with the first quarter of 2006.
In addition, options are issued to non-employees such as consultants, scientific
advisory board members and directors. 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 6).
(M)
Use of Estimates
The
preparation of financial statements in accordance with accounting principles
generally accepted in the United States of America requires management to make
estimates and assumptions that affect the reported amounts of assets and
liabilities and disclosure of contingent assets and liabilities at the date of
the financial statements and the reported amounts of revenue and expenses during
the reporting period. Actual results could differ from those
estimates.
(N)
Impairment of Long-Lived Assets
The
Company evaluates the recoverability of its long-lived assets, where indicators
of impairment are present, by reviewing current and projected profitability or
undiscounted cash flows of such assets. Intangible assets that are subject to
amortization are reviewed for potential impairment whenever events or
circumstances indicate that carrying amounts may not be recoverable. Intangible
assets not subject to amortization are tested for impairment at least annually.
For the years ended December 31, 2004 and 2003, the Company determined that an
impairment charge on its long-lived assets was not required.
(O)
Research and Development Expense
R&D
costs are expensed as incurred. These expenses include the cost of the Company's
proprietary R&D efforts, as well as costs incurred in connection with the
Company's third-party collaboration efforts.
(P)
Advertising
The
Company expenses the cost of advertising and promotions as incurred. Advertising
costs charged to operations amount to $101,712 and $174,514 for the years ended
December 31, 2004 and 2003, respectively.
VIOQUEST
PHARMACEUTICALS, INC. AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER
31, 2004 AND 2003
(Q)
Loss Per Share
Basic net
loss per share is calculated by dividing net loss by the weighted-average number
of shares outstanding for the period. Diluted net loss per share is the same as
basic net loss per share, since potentially dilutive securities from the assumed
exercise of stock options and stock warrants would have an antidilutive effect
because the Company incurred a net loss during each period presented. The amount
of potentially dilutive securities including options and warrants in aggregate
excluded from the calculation was 5,141,009 at December 31, 2004 and 2,841,607
at December 31, 2003.
NOTE
2 INVENTORY
The
principal components of inventory are as follows:
|
|
December
31, 2004 |
|
December
31, 2003 |
|
Raw
material compounds |
|
$ |
308,456 |
|
$ |
25,796 |
|
Work
in process |
|
|
47,691 |
|
|
42,251 |
|
Finished
goods |
|
|
4,000 |
|
|
8,845 |
|
Total
Inventory |
|
$ |
360,147 |
|
$ |
76,892 |
|
NOTE
3 PROPERTY
AND EQUIPMENT, NET
The cost
of the major classes of property and equipment are as follows:
|
|
December
31, 2004 |
|
December
31, 2003 |
|
Laboratory
equipment |
|
$ |
519,231 |
|
$ |
272,713 |
|
Office
equipment |
|
|
7,849 |
|
|
4,780 |
|
Computer
equipment |
|
|
35,241 |
|
|
26,131 |
|
Leasehold
improvements |
|
|
145,783 |
|
|
47,932 |
|
Property
and Equipment |
|
|
708,104 |
|
|
351,556 |
|
Less
Accumulated depreciation |
|
|
214,472 |
|
|
96,907 |
|
Property
and Equipment, Net |
|
$ |
493,632 |
|
$ |
254,649 |
|
Depreciation
expense for property and equipment for the years ended December 31, 2004 and
2003 was $125,467 and $49,583, respectively.
NOTE
4
INCOME
TAXES
There was
no income tax expense or benefit for the years ended December 31, 2004 and 2003
because of the nonrecognition of the income tax benefit from the Company’s net
operating loss carryforwards.
VIOQUEST
PHARMACEUTICALS, INC. AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER
31, 2004 AND 2003
The
significant components of the Company’s net deferred tax assets are summarized
as follows:
|
|
Year
Ended December 31 |
|
|
|
2004 |
|
2003 |
|
Net
operating loss carryforwards |
|
$ |
2,870,000 |
|
$ |
1,260,000 |
|
|
|
|
|
|
|
|
|
Valuation
allowance |
|
|
(2,870,000 |
) |
|
(1,260,000 |
) |
|
|
|
|
|
|
|
|
Net
deferred tax assets |
|
$ |
- |
|
$ |
- |
|
Deferred
tax assets of $2,870,000 and $1,260,000 as of December 31, 2004 and 2003,
respectively, consist primarily of the potential tax benefit of net operating
loss carryforwards of $-7,175,000 and $3,150,000 at December 31, 2004 and 2003,
respectively, and have been fully offset by a valuation allowance because it is
management’s belief that it is more likely than not that those benefits will not
be realized. Accordingly, the Company recognized no tax benefit for its pre-tax
loss in 2004 or 2003. The net operating loss carryforwards, if not used, expire
through 2024.
Following is a reconciliation of the expected income
tax benefit computed at the U.S. Federal statutory rate to the Company's actual
income tax benefit:
|
|
December
31, 2004 |
|
December
31, 2003 |
|
Income
tax benefit at statutory rate |
|
|
(1,368,010 |
) |
|
(686,256 |
) |
State
income taxes net of Federal tax |
|
|
(241,413 |
) |
|
(121,104 |
) |
Increase
in valuation allowance |
|
|
1,609,423 |
|
|
807,360 |
|
|
|
$ |
- |
|
$ |
-
|
|
NOTE
5 RIGHTS
TO INTELLECTUAL PROPERTY
The
Company’s exclusive right to certain PSRF patents are of material importance to
the Company's success. These PSRF patents result from inventions by the
Company’s Chief Technology Officer (“CTO”), who is also an employee at
Pennsylvania State University. The PSRF patents cover chemical formulations,
processes for or intermediates useful in the manufacture of products and the
uses of products. Protection for PSRF’s individual products extends for varying
periods in accordance with the date of grant and the legal life of patents in
the various countries. The protection afforded, which may also vary from country
to country, depends upon the type of patent and its scope of coverage. The
Company is financially responsible for all aspects of these PSRF inventions,
including legal and R&D expenses associated with the chemical developments.
The Company is no longer obligated to license future inventions of the
CTO.
For the
years ended December 31, 2004 and 2003, the Company has not recognized any
impairment charges to its patents, as management believes that the Company’s
patents have useful lives equivalent to their amortization period of seventeen
years.
NOTE
6 STOCKHOLDERS'
EQUITY
VIOQUEST
PHARMACEUTICALS, INC. AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER
31, 2004 AND 2003
In
connection with the Merger (see Note 1), the Company issued a warrant to
purchase 550,000 shares of common stock at an exercise price of $1.25 to an
independent consultant for services related to the Merger.
During
May 2003, the Company issued options to purchase, at a price of $1.50 per share,
an aggregate of 20,000 shares of common stock to the landlord of new office
space that the Company is leasing in New Jersey. The option issuance resulted in
a charge to deferred expenses in stockholders’ equity of $9,845 for the value of
the shares and is being amortized to rent expense over the term of the lease
beginning in July 2003.
In June
2003, the Company issued options to purchase an aggregate of 740,052 shares of
common stock at exercise prices of $1.49 and $1.50 per share to two consultants
(including 650,052 options issued to the CTO) and two members of the Company’s
Scientific Advisory Board. The total value of the option issuances of $619,864
was valued using the Black-Scholes option pricing model with the following
assumptions: a risk-free interest rate of approximately 2.4%, volatility of
approximately 87%, lives of five years and an assumed dividend yield of 0%. The
option issuances were charged to deferred expense in the stockholders’ equity
and are being amortized to consulting expense over the applicable service
periods.
In
October 2003, a consultant for the Company received options to purchase 4,300
shares of common stock at an exercise price of $1.96 per share. These options
became fully vested on February 14, 2004. The total value of the option issuance
resulted in a charge to deferred expenses in stockholders' equity of $6,263 was
valued using the Black-Scholes option pricing model with the following
assumptions.
In
November 2003, a consultant for the Company received options to purchase 2,500
shares of common stock at an exercise price of $1.96 per share. These options
vested in April 2004. The total value of option issuance resulted in a change to
deferred expenses in stockholders' equity of $3,643 was valued using the
Black-Scholes option pricing model with the following assumptions: a risk-free
rate of 3%, volatility of 128%, estimated lives of three years and an assumed
dividend yield of 0%.
On
February 25, 2004, the Company completed a private placement of its securities
to accredited investors that resulted in gross proceeds of approximately $7.2
million. Investors in the private placement purchased an aggregate of
approximately 4.8 million shares of the Company’s common stock at a price per
share of $1.50 and received 5-year warrants to purchase one share of common
stock at $1.65 per share for every two common shares purchased in the offering
(a total of 2.4 million warrants). ThinkEquity Partners LLC, Paramount
BioCapital, Inc. and Casimir Capital L.P. acted as the placement agents for this
offering and received fees of approximately $500,000 of which Paramount
BioCapital, Inc., a related party, received $300,000. Net proceeds to the
Company, after deducting commissions and other expenses relating to the private
placement, were approximately $6.7 million.
VIOQUEST
PHARMACEUTICALS, INC. AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER
31, 2004 AND 2003
The
following table summarizes the total number of shares outstanding, shares issued
to non-employees, directors, consultants, scientific advisory board members and
options that have expired:
|
|
2004 |
|
|
|
|
|
|
|
Weighted |
|
|
|
Weighted |
|
|
|
|
|
Average |
|
|
|
Average |
|
|
|
|
|
Exercise |
|
|
|
Exercise |
|
|
|
Shares |
|
Price |
|
Shares |
|
Price |
|
|
|
|
|
|
|
|
|
|
|
Outstanding
at beginning
of year |
|
|
2,841,607 |
|
$ |
1.47 |
|
|
998,105 |
|
$ |
1.48 |
|
Granted |
|
|
366,000 |
|
$ |
1.22 |
|
|
1,843,752 |
|
$ |
1.47 |
|
|
|
|
(962,730 |
) |
$ |
1.49 |
|
|
(250 |
) |
$ |
2.80 |
|
Outstanding
at end of
year |
|
|
2,244,877 |
|
$ |
1.42 |
|
|
2,841,607 |
|
$ |
1.47 |
|
Options
exercisable at
year-end |
|
|
1,024,488 |
|
$ |
1.38 |
|
|
1,114,755 |
|
$ |
1.37 |
|
Weighted-average
fair
value of options
granted during
the year |
|
$ |
1.14 |
|
|
|
|
$ |
0.63 |
|
|
|
|
The
following table summarizes the information about Plan stock options outstanding
at December 31, 2004:
Range
of Exercise Prices |
|
Outstanding
Options |
|
Weighted
Average Exercise Price |
|
Weighted
Average Remaining Life In Years |
|
$1.00
- $1.99 |
|
|
2,225,252 |
|
$ |
1.41 |
|
|
8 |
|
$2.00-$2.99 |
|
|
16,500 |
|
$ |
2.15 |
|
|
7 |
|
$3.00-$3.99 |
|
|
875 |
|
$ |
3.20 |
|
|
2 |
|
$4.00-$12.00 |
|
|
2,250 |
|
$ |
7.29 |
|
|
0 |
|
Total
|
|
|
2,244,877 |
|
|
|
|
|
|
|
The
following table summarizes information related to warrants outstanding
at
December 31, 2004:
Remaining
Contractual Life In Years |
|
Price |
|
Number
of Exercisable Outstanding Warrants |
|
4.15 |
|
$ |
1.65 |
|
|
2,896,132
|
|
NOTE
7 AGREEMENTS
Pursuant
to a January 2002 agreement between the Company and a pharmaceutical product
development customer, the Company granted the customer a worldwide,
non-exclusive, royalty free license to certain of the Company’s Intellectual
Property Rights for research purposes only in connection with certain of the
customer’s compounds. The customer paid the Company a nonrefundable license fee
of $400,000 in 2002. The fee is being amortized to revenue through September
2005 when the agreement terminates. For each of the years ended December 31,
2004 and 2003, the Company recognized income of $114,241 related to this
agreement.
VIOQUEST
PHARMACEUTICALS, INC. AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER
31, 2004 AND 2003
In August
2002, the Company entered into a one-year scientific research agreement with
another pharmaceutical product development customer to assist in the completion
of a feasibility screening program and report. In consideration for the
experimental activity, the customer paid a fee of $30,000. The fee has been
amortized to revenue through August 2003. For the year ended December 31, 2003,
the Company recognized income of $19,726.
In May
2003, the Company entered into a four-year consulting agreement with the CTO at
an annual rate of $120,000 per year. In addition, the CTO received an option to
purchase 650,052 shares of common stock at $1.49 per share as mentioned in Note
5.
In May
2003, the Company entered into an option agreement with the Science and
Technology Bureau of Jiashan County in Zhejiang, Province of the People’s
Republic of China, China (“Jiashan”), whereby the Company has an option to
acquire a laboratory facility in an industrial park near Shanghai. Jiashan is
currently building laboratory space to the Company's specifications, which is
expected to be completed by the second quarter of 2005. The Company will not pay
rent for the initial three years of the lease, following which the Company, at
its sole option, may rent the space for annual rent of no more than $60,000. In
addition, the Company will have the option to purchase the lab on commercially
reasonable terms. Should the Company wish to occupy the laboratory after its
estimated completion in the second quarter of 2005, it will begin to pay a
maintenance fee of $4,500 per month which consists of operating expenses related
to property management fees and waste removal. For purposes of entering into the
lease, the Company established a wholly owned subsidiary in Hong Kong, Chiral
Quest Ltd., which in turn will be the sole shareholder of a subsidiary in the
People's Republic of China (the “China Sub”). The Company has provided $66,000
of capital to the China Sub through December 31, 2004. In addition, the Company
was also granted the option to purchase for $750,000 approximately 33 acres of
land adjacent to the industrial park where the lab will be established.
Pursuant
to an October 2002 agreement with Penn State, the Company funded the services of
four post-doctorate fellows who, under the supervision of the CTO, conducted
research and provided research quantities of chiral ligands to the Company. From
October 2002 through December 31, 2004, the Company has paid and incurred
expenses of approximately $596,000 pursuant to the agreement. This amount
consists principally of four post-doctorate salaries, fringe benefits, materials
and supplies for the stated period. The agreement expires on April 14, 2005. The
approximate obligation payable by the Company for the remaining period through
April 14, 2005 is $98,000.
NOTE
8 BUSINESS
AND CREDIT CONCENTRATIONS
The
Company had two customers which accounted for approximately 34% and 26%, a major
pharmaceutical company and a biotechnology company respectively, of revenue for
the year ended December 31, 2004. The Company had two customers who accounted
for approximately 54% and 17%, respectively, of revenue for the year ended
December 31, 2003.
VIOQUEST
PHARMACEUTICALS, INC. AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER
31, 2004 AND 2003
The
Company had two customers who accounted for approximately 42% and 19%,
respectively, of net customer accounts receivable as of December 31, 2004. The
Company had two customers who accounted for approximately 52% and 39%,
respectively, of net accounts receivable as of December 31, 2003.
NOTE
9 COMMITMENTS
AND CONTINGENCIES
The
Company entered into a written employment agreement dated as of February 1, 2005
with Daniel Greenleaf, its newly-appointed President and Chief Executive
Officer. The agreement provides for a 3-year term and an initial annual base
salary of $360,000, plus a guaranteed annual bonus of $100,000 during each year
of the term of the agreement. In addition, Mr. Greenleaf is entitled to a
signing bonus in the amount of $50,000, of which one-half is payable following
the execution of the employment agreement and the remaining one-half is payable
on the 6-month anniversary of the agreement. Mr. Greenleaf is further entitled
to a “Discretionary Bonus” under the employment agreement of up to $250,000 per
year upon the attainment of certain performance criteria specified in the
employment agreement, and such other benefits generally made available to the
Company’s other senior management.
The
employment agreement also provides that Mr. Greenleaf is entitled to receive an
option to purchase 891,396 shares of the Company’s common stock, which
represents 5 % of the Company’s currently outstanding common stock. The option
will vest in three equal annual installments, commencing February 2006. In
addition, until the Company has raised $20 million through the sale of equity
securities and has obtained the rights to one clinical stage human therapeutic,
Mr. Greenleaf shall be entitled to receive such additional options to purchase
common stock in order to maintain his beneficial ownership (assuming the
exercise of all stock options issued to Mr. Greenleaf) at 5% of the Company’s
outstanding common stock. To the extent any additional stock options are issued
pursuant to the foregoing sentence, the options will vest in installments over
the term of the employment agreement as long as Mr. Greenleaf remains employed
by the Company and will be exercisable at the market value of the Company’s
common stock at the time of issuance.
In the
event Mr. Greenleaf’s employment is terminated by the Company during the term
upon a “change of control” (as defined in the employment agreement) and on the
date of such termination the Company’s aggregate market capitalization is less
than $38 million, he is entitled to receive his base salary for six months
thereafter and all of his stock options scheduled to vest in the calendar year
of such termination shall accelerate and be deemed vested upon termination and
will remain exercisable for 12 months following such termination. In the event
the Company terminates Mr. Greenleaf’s employment during the term of the
agreement other than as a result of death, disability, cause or in connection
with a change of control where the Company’s aggregate market capitalization is
less than $38 million, then (i) Mr. Greenleaf is entitled to receive his base
salary for 12 months from such termination, his guaranteed bonus for the
calendar year in which such termination occurs, and the portion of any
discretionary bonus earned as of the termination, and (ii) the vesting of his
stock options shall accelerate and be deemed vested and will remain exercisable
for 12 months following such termination.
The
Company leases laboratory and office space located in Monmouth Junction, New
Jersey. The lease as amended commenced effective June 1, 2003 and is for a
three-year term with a total rent, utilities and maintenance to be paid in
monthly installments that increase each year. Due to the escalation clause in
the lease, the Company is straight-lining the expense of the lease over the term
of the lease. The Company also issued the landlord options to purchase 20,000
shares of common stock, as described in Note 6. The fair value of the options
issued to the landlord of $9,845 is being amortized on a straight-line basis
over the term of the option agreement and included in rent expense.
VIOQUEST
PHARMACEUTICALS, INC. AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER
31, 2004 AND 2003
Future
minimum rental payments subsequent to December 31, 2004 are as
follows:
Years
ended December 31, |
|
2005 |
|
$ |
281,000 |
|
2006 |
|
|
119,000 |
|
|
|
$ |
400,000 |
|
Total
rent expense (which includes base rent, utilities, and operating escalations for
both the New Jersey lease and a month to month lease of laboratory space in
Pennsylvania) for the Company for the year ended December 31, 2004 and 2003 was
approximately $333,000 and $101,000 respectively.
NOTE
10 RETIREMENT
PLAN
The
Company sponsors a defined contribution 401(k) plan which allows eligible
employees to defer a portion of their salaries for income tax purposes by making
contributions to the plan. There have been no Company contributions to the plan
for the years ended December 31, 2004 and 2003.
NOTE
11 RELATED
PARTY TRANSACTIONS
Paramount
BioCapital Investments, LLC, a related party, has been performing certain
administrative functions for the Company since July 12, 2002, and financed the
Company through loans for working capital evidenced by a series of promissory
notes (the “Notes”) aggregating $376,625. The Notes bore interest at 5% per
annum. The Company satisfied in full all principal and accrued interest under
the Notes on February 28, 2003.
Additionally,
from September 2002 through April 2004, the Company was paying $4,000 per month
to Paramount BioCapital Investments, LLC, for an office and general and
administrative services. For the years ended December 31, 2004 and 2003, this
resulted in charges to operations of $6,000 and $48,000, respectively. As of
December 31, 2003, the Company owed $1,201 to Paramount BioCapital Investments,
LLC.
On
February 25, 2004, the Company completed the sale of its securities in a private
placement to accredited investors for gross proceeds of approximately $7.2
million. Paramount BioCapital, Inc. participated as one of three placement
agents for this transaction, for which it received approximately $300,000 in
commissions.