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SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
----------
FORM 10-K
(Mark One)
[X] ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
For the fiscal year ended December 31, 2002
OR
[ ] 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 0-27046
ORTEC INTERNATIONAL, INC.
(Exact name of registrant as specified in its charter)
11-3068704
Delaware (I.R.S. Employer
(State or other jurisdiction of Identification No.)
incorporation or organization)
3960 Broadway
New York, New York 10032
(Address of principal executive offices (Zip Code)
Registrant's telephone number, including area code: (212) 740-6999
Securities registered pursuant to Section 12(b) of the Act: None
Securities registered pursuant to Section 12(g) of the Act: Common Stock,
$.001 par value
Indicate by check mark whether the Registrant (1) has filed all
reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the
Registrant was required to file such reports), and (2) has been subject to such
filing requirements for the past 90 days. Yes [X] No
Indicate by check mark if disclosure of delinquent filers pursuant to
Item 405 of Regulation S-K ('SS'229.405 of this chapter) is not contained
herein, and will not be contained, to the best of Registrant's knowledge, in
definitive proxy or information statements incorporated by reference in Part III
of this Form 10-K or any amendment to this Form 10-K.
The number of shares outstanding of the Registrant's common stock is
26,547,768 (as of 4/7/03). The aggregate market value of the voting stock held
by nonaffiliates of the Registrant was approximately $5,107,487 (as of 4/7/03,
based upon a closing price of the Company's Common Stock on the Nasdaq Bulletin
Board on such date of $0.20).
DOCUMENTS INCORPORATED BY REFERENCE
None.
ORTEC INTERNATIONAL, INC.
INDEX TO ANNUAL REPORT ON FORM 10-K
FILED WITH THE SECURITIES AND EXCHANGE COMMISSION
FOR THE FISCAL YEAR ENDED DECEMBER 31, 2002
ITEMS IN FORM 10-K
Page
----
Facing page
Part I
Item 1. Business.............................................................1
Item 2. Properties...........................................................6
Item 3. Legal Proceedings....................................................7
Item 4. Submission of Matters to a Vote of Security Holders................N/A
Part II
Item 5. Market for the Registrant's Common Equity and Related
Stockholder Matters...............................................8
Item 6. Selected Financial Data.............................................12
Item 7. Management's Discussion and Analysis of Financial
Condition and Results of Operations..............................14
Item 7A. Quantitative and Qualitative Disclosures About Market Risk.........N/A
Item 8. Financial Statements and Supplementary Data.........................24
Item 9. Changes in and Disagreements with Accountants
on Accounting and Financial Disclosure..........................N/A
Part III
Item 10. Directors and Executive Officers of the Registrant..................25
Item 11. Executive Compensation..............................................28
Item 12. Security Ownership of Certain Beneficial Owners
and Management and Related Stockholder Matters...................31
Item 13. Certain Relationships and Related Transactions......................35
Item 14. Controls and Procedures.............................................36
Part IV
Item 15. Exhibits, Financial Statement Schedules and Reports on Form 8-K.....38
Signatures.......................................................................40
PART I
Item 1. BUSINESS
Overview
We are a development stage tissue engineering company that has developed a
proprietary and patented technology that we call "OrCel", which is used to
stimulate the repair and regeneration of human skin. OrCel is a two layered
tissue engineered dressing that consists of human derived skin cells, both
dermal and epidermal, supported within a porous collagen matrix. The composite
matrix is seeded with keratinocytes for epidermal growth and fibroblasts for
dermal growth. When OrCel is applied to the wound site, it produces a mix of
growth factors that stimulates wound closure.
In 2001 the FDA granted our application for the commercial sale of OrCel
for the treatment of donor site wounds. In 2001 the FDA also granted our
application for the commercial sale of OrCel for use on patients with recessive
dystrophic epidermolysis bullosa undergoing hand reconstruction, as well as to
treat the donor site wounds created during the surgery. From December 2001
through December 2002, our gross revenues from the sale of OrCel were $265,665.
We discontinued our sales efforts and the manufacture of OrCel for commercial
sale because of our need to use our limited financial resources for the
completion of our clinical trial for the use of OrCel in the treatment of venous
stasis ulcers, which is a much larger potential market.
We are currently conducting a pivotal clinical trial for the use of OrCel
in its cryopreserved form for the treatment of venous stasis ulcers. The study
is being conducted at 13 clinical sites, and as of March 14, 2003, over 80
patients were enrolled to participate in the trial. We are targeting an
enrollment of 102 patients in the trial after which the trial can be considered
completed upon our demonstrating that there is a significant positive
statistical difference in the treatment of enrolled patients with OrCel as
compared with the treatment of other enrolled patients, in a control group, with
standard of care. We can then file a pre-market application with the FDA for the
FDA's approval of the commercial sale of OrCel for the treatment of venous
stasis ulcers. The results of the trial so far are encouraging.
We have developed the technology for the cryopreservation of OrCel without
diminishing its effectiveness. Cryopreservation is the freezing of our product
which gives it a minimum shelf life of six months, as opposed to only a few days
when our product is not cryopreserved.
Due to budgetary constraints we are encountering in this difficult
investment climate, we have deferred conducting a pivotal clinical trial for the
use of OrCel in the treatment of diabetic foot ulcers (although the FDA granted
its approval for us to conduct that pivotal trial) until after we have completed
our pivotal clinical trial, now in progress, for the use of OrCel in the
treatment of venous stasis ulcers. We completed a pilot clinical trial for the
use of OrCel in the treatment of diabetic foot ulcers in the latter part of
2001. We reported the favorable results of that pilot clinical trial in our
annual report on Form 10-K for the fiscal year ended December 31, 2001.
1
People with diabetic foot ulcers also constitute a large patient population and
therefore also a large potential market for OrCel.
In December 2001 OrCel was approved by the Centers for Medicare Services
for inclusion on the Outpatient Prospective Payment Systems Pass Through List.
The inclusion on this list allows prescribers to recover their cost for OrCel
from Medicare when utilizing OrCel for treatment of a Medicare patient as a
hospital outpatient.
Our target patient population for the use of OrCel are persons with venous
stasis and diabetic foot ulcers and donor site wounds which we believe are large
potential markets for the use of OrCel. We also believe that OrCel can be used
to treat other medical conditions, such as decubitis ulcers, and for cosmetic
surgery.
Our cash on hand at the end of March 2003 will enable us to continue our
operations through May, 2003, assuming that we will not incur unexpected costs
and that we are able to manage payments, over a period of time, of obligations
we have accumulated. Before the end of May, 2003, we will be required to raise
additional funds (through the sale of our securities or debt financing) to
complete our clinical trials, to produce and market OrCel and to pay our
accumulated debt. Our failure to receive additional financing will have a
material adverse effect on our operations. If we secure the additional funding
we need, receive FDA approval for commercial sales of OrCel for treatment of
medical conditions with large patient populations, successfully market OrCel and
can rely on a third party contract manufacturer to produce OrCel in the quantity
we need at the cost we now estimate, we believe that we will have the
opportunity to reach cash break even in 2005.
Ortec was organized in 1991 under the laws of the State of Delaware for the
purpose of acquiring, developing, testing and marketing our skin replacement
product. Our executive offices are located at 3960 Broadway, New York, New York,
and our telephone number is (212) 740-6999. Our website address is
www.ortecinternational.com.
The Product
OrCel cells are derived from infant foreskins obtained during routine
circumcisions. The immature, neonatal cells are highly reproductive and provide
enhanced proliferation and rapid remodeling of the human skin. We separate the
epidermis from the dermis and treat each of these layers to release individual
keratinocyte (epidermal) and fibroblast (dermal) cells, which are the primary
cellular components of human skin. We grow the fibroblast and keratinocyte cells
in culture in large quantities, then freeze and store them as a cell bank, ready
for use. Prior to the use of each cell line, we conduct extensive testing and
screening in accordance with current FDA guidelines to ensure that the cells are
free of presence of bacterial contaminants, viruses, pathogens, tumorigenicity
or other transmittable diseases. We then apply the dermal fibroblast cells to a
proprietary, cross-linked bovine collagen sponge to form the dermal layer matrix
and we grow the epidermal keratinocyte cells on a separate non-porous layer of
collagen. We then incubate and supply this composite matrix with the proper
nutrients to allow the cells to multiply and for the fibroblasts to permeate
inside and anchor to the porous collagen sponge.
2
The top layers of keratinocyte cells and bottom layers of fibroblast cells in
the collagen matrix, together, constitute our proprietary OrCel, which we can
then deliver to customers in a fresh or cryopreserved state.
Original Research
Our technology was developed by Dr. Mark Eisenberg, a physician in Sydney,
Australia. Dr. Eisenberg is an officer and director and one of the founders of
Ortec. He has been involved in biochemical and clinical research at the
University of New South Wales in Australia for over twenty five years, focusing
primarily on treating the symptoms of epidermolysis bullosa. In 1987, through
his work on epidermolysis bullosa, Dr. Eisenberg first succeeded in growing
epidermal layers of human skin, which he successfully applied as an allograft on
an epidermolysis bullosa patient. An allograft is a transplant other than with
the patient's own skin. Dr. Eisenberg continued his research which eventually
led to the development of OrCel - a tissue-engineered dressing which consists of
both the dermal and epidermal layers.
Regulatory Strategies, Product Development and Sales
We employ a team of regulatory and clinical professionals, both full time
employees and consultants, with extensive knowledge in strategic regulatory and
clinical trial planning to support our product development efforts through every
stage of the development and FDA approval process. We also employ persons with
extensive knowledge and experience in the marketing and sale of new FDA approved
products for treatment of many medical conditions, including experience in
securing approval of insurance companies to reimburse their insured patients for
the cost of the use of new medical products used in medical treatments. We have
already secured approval for Medicare payments for the use of OrCel.
Production and Supply
We believe that the production capacity at our facility in the Audubon
Biomedical Science and Technology Park in New York City is sufficient to supply
the amount of OrCel we need for our clinical trials and for limited amounts of
commercial sales. If we achieve a significant volume of sales we will need
production facilities capable of producing much larger quantities of OrCel. We
initially planned to construct our own manufacturing facilities for the
production of OrCel for commercial sales. However, due to the difficulty in
securing investment capital in this difficult investment climate, and the large
amount we would have to invest to construct our own production facilities, our
current plans call for the manufacture of OrCel in large quantities by a third
party contract manufacturer experienced in production of cell based medical
products, whose production facilities are in compliance with the good
manufacturing processes and quality system regulations mandated by the FDA. We
are now negotiating with such third party contract manufacturers to produce
OrCel. Based on our discussions we believe that the production of OrCel by such
a third party manufacturer will allow us to produce OrCel at a lower cost,
particularly considering the significant investment we would otherwise have to
make in creating our own manufacturing facility. Our production facility in the
Audubon Biomedical Science and Technology Park was inspected and approved by the
FDA in September 2000 for the manufacture of OrCel. We anticipate that even when
we use third party production
3
facilities we may still be required to make a financial contribution, over a
period of time, to modify those production facilities for our use and, if we are
successful in our marketing efforts, to expand those third party manufacturing
facilities.
Competition
We are aware of several companies that are actively engaged in the research
and development of products for the repair and regeneration of skin. There are
currently three primary and distinct approaches to the repair and regeneration
of skin: the acellular (no cell) approach, including the use of cadaver based
products; the cell-based unilayered (epidermal or dermal cell) approach, and the
cell based bi-layered (epidermal and dermal cell) approach. The approach we
believe to be the most advanced and effective is the bi-layered approach, which
we use.
There is also a procedure which cultures the patient's own epidermal cells
to create an epidermis like layer. That procedure takes a number of weeks to
create that epidermal layer. Genzyme Biosurgery is currently selling such a
product for treatment of severely burned patients only, pursuant to an FDA
humanitarian device exemption.
We previously considered Organogenesis, Inc. and Advanced Tissue Sciences,
Inc. to be our principal competitors because each of them was previously
manufacturing and selling a tissue engineered product approved by the FDA for
the treatment, in the case of Organogensis' Apligraf, of both venous stasis and
diabetic foot ulcers, and in the case of Advanced Tissue Sciences' Dermagraft
for the treatment of diabetic foot ulcers. Advanced Tissue Sciences' Dermagraft
was manufactured in a cryopreserved form while Organogenesis' Apligraf was not.
However, in 2002 both Organogenesis and Advanced Tissue Sciences filed for
bankruptcy protection. Advanced Tissue Sciences had entered into a joint venture
agreement with Smith & Nephew, a major pharmaceutical company, for the
distribution of Dermagraft. According to publicly available information Smith &
Nephew has purchased Advanced Tissue Sciences' half interest in their joint
venture. We believe that Smith & Nephew will resume manufacturing and selling
Dermagraft, if it has not already done so. Organogenesis had entered into an
agreement with Novartis Pharmaceuticals, also a major pharmaceutical company,
for Novartis to distribute Organogenesis' Apligraf. As a result of
Organogenesis' bankruptcy that distribution agreement was modified to terminate
on June 30, 2003. Organogensis announced that it planned to resume manufacturing
and selling its Apligraf product and it may have already done so. Smith &
Nephew, and any pharmaceutical company that may distribute Apligraf in the
future, is substantially larger than we are and has significantly greater
financial, marketing and other resources than we have. Such greater financial
and other resources will put us at a disadvantage in marketing OrCel despite
what we believe are certain advantages OrCel has (such as ease of application
and greater mix of growth factors which appear to enable a quicker healing
process, and in the case of Organogenesis' Apligraf, the fact that OrCel can be
sold in a cryopreserved form and Apligraf cannot). We can give no assurance that
we will be able to enter into joint venture or distribution agreements with
pharmaceutical or health product distribution companies that are strong
financially and in their marketing capabilities, on terms, if at all, that will
make our operations profitable.
4
The biomedical field is continually undergoing rapid and significant
technological changes. Other companies may succeed in developing other products
that are more effective than OrCel. If such new products are accepted by the
medical community, or if those products receive FDA approval for treatment of
venous stasis and diabetic foot ulcers before OrCel does, or if other companies
develop products that are more effective than OrCel, any such developments may
have a material adverse effect on our business, results of operations and
financial condition.
Patents and Proprietary Rights
We have four United States patents, one European patent covering thirteen
countries and ten international patents in ten other countries, and two United
States and four international patent applications (three of which are
applications filed under the Patent Cooperation Treaty) pending, for our
technology and processes. However, our success will depend, in part, on our
ability to maintain trade secret protection for our technology. Our European
patent was granted to us by the European Patent Office and was challenged by
Advanced Tissue Sciences in an opposition proceeding. We successfully defeated
that opposition. Advanced Tissue Sciences has appealed that determination in our
favor and the appeal is currently pending.
The validity and breadth of claims in medical technology patents involves
complex legal and factual questions and, therefore, are highly uncertain. We do
not know if any pending patent applications or any future patent application
will issue as patents, that the scope of any patent protection obtained will be
enough to exclude competitors or that any of our patents will be held valid if
subsequently challenged in court proceedings. We do not know if others have or
will develop similar products, duplicate any of our products or design around
any of our patents issued or that may be issued in the future. In addition,
whether or not patents are issued to us, others may hold or receive patents
which contain claims having a scope that covers aspects of our products or
processes.
Several of our competitors, including Organogenesis and Advanced Tissue
Sciences, Inc., have been granted patents relating to their particular skin
technologies.
We successfully defended challenges to our United States and European
patents in the respective patent offices where those patents were issued.
However, those successful defenses do not preclude future challenges in court.
The dismissal of the challenge to our patent in Europe has been appealed. We do
not know if any of the other patents issued to us will be challenged,
invalidated or circumvented. Patents and patent applications in the United
States may be subject to interference proceeding brought by the U.S. Patent and
Trademark Office, or to opposition proceedings initiated in a foreign patent
office by third parties or to re-examination proceedings in the United States.
We might incur significant costs defending such proceedings and we might not be
successful.
In August 2001 and in 2002 we entered into agreements with Paul Capital
Royalty Acquisition Fund, L.P. pursuant to which we agreed to pay to Paul
Capital 3 1/3% of the end user sales prices paid for our product in the United
States, Canada and Mexico through the period ending in 2011.
5
As security for the performance of our obligations to Paul Capital, we granted
Paul Capital a security interest in all of our U.S. patents, patent applications
and trademarks. If there are defaults on our part in our performance of our
agreements with Paul Capital, including defaults occasioned by events beyond our
control (such as our insolvency), and we are unable to pay Paul Capital the
large amounts required to be paid by us because of our default, Paul Capital may
foreclose its security interest in our U.S. patents, patent applications and
trademarks and it is most likely that in such event we will have to discontinue
our operations.
Employees
We presently employ 35 people on a full-time basis, including three
executive officers. We also have 5 part time employees. We anticipate hiring
additional employees in the areas of quality assurance, manufacturing, marketing
and research and development as our needs arise.
Item 2. PROPERTIES
We occupy an aggregate of approximately 14,000 sq. ft. of space in Columbia
University's Audubon Biomedical Science and Technology Park in New York City,
pursuant to [four] separate lease agreements, for laboratory and office space.
We use our laboratories for assay development, wound healing research,
biomaterial development, bioprocess development, histology, quality assurance
testing and for two clean rooms where we produce OrCel. As of March 1, 2003 we
were paying rent of approximately $55,000 per month for use of all our space at
the Audubon facility.
In December 2001 we entered into a ten-year lease with the New Jersey
Economic Development Agency to lease approximately 58,000 square feet of
manufacturing and office space located in North Brunswick, New Jersey. The
leased premises were to be located in two buildings. 26,000 square feet in an
existing building were to be renovated to our specifications. The other 32,000
square feet was to be a building specifically constructed for us. We planned to
equip that space primarily for the production and manufacturing of OrCel in
large quantities for commercial sale. However, as we noted above, because our
financial resources are significantly more limited than we anticipated when we
signed the lease, we were able to terminate our obligation for the leasing
of the 32,000 square feet building that was to be constructed and we have
had discussions with the New Jersey Economic Development Agency to defer or
terminate the remainder of our obligation to lease the other 26,000 square feet.
We can give no assurance that we will be able to defer or terminate our
obligation with respect to the 26,000 square feet portion of that lease or what
damages, if any, incurred by the New Jersey Economic Development Agency because
of our failure to perform our obligations relating to the 26,000 square feet
portion of that lease, we will have to pay.
Before we changed our plans and decided not to build production facilities
in North Brunswick, we also leased from the same landlord approximately 3,200
square feet in another building in North Brunswick, for a 16 month term, at an
initial base rent of $30.00 per square foot during the first year, increasing to
$31.50 per square foot during the last four months of the lease.
6
That lease expires June 30, 2003. We are currently using that space for process
development operations and offices.
Item 3. LEGAL PROCEEDINGS
ClinTrials Networks, LLC (ClinTrials) has claimed that we have breached an
agreement with them, which provided for ClinTrials to arrange and manage a
portion of the FDA mandated clinical trials for use of our OrCel product for the
treatment of venous stasis ulcers, and for other services. During the quarter
ended September 30, 2002, ClinTrials commenced an arbitration proceeding against
us, claiming that we owe ClinTrials $165,936 and that ClinTrials reserves the
right to claim additional amounts from us, based on continuing additional
monthly fees ClinTrials claims that it is entitled to receive under its
agreement with us. We have denied ClinTrials' claim and have advised ClinTrials
that we are not in breach of our agreement. We have filed a counterclaim in the
arbitration proceeding for overpayments of $75,000 under the terms of our
agreement with ClinTrials.
During the quarter ended September 30, 2002, PDI, Inc. commenced an action
against us in the Superior Court of New Jersey, Bergen County, claiming that we
owe $205,000 to PDI for services that they have performed for us. We are in the
process of discussing a settlement of the amount claimed with PDI.
In December 2002 Amarex LLC commenced an action against us in the Circuit
Court for Montgomery County, Maryland. Amarex provided statistical programming
and data management services for us for the data generated in our clinical
trials. Although in its complaint Amarex claims we owe it $2,457,875, that
amount is the additional amount we would have had to pay Amarex if Amarex had
performed all the work needed for all our contemplated clinical trials. We have
answered Amarex's complaint denying Amarex's claim. We are negotiating with
Amarex to establish the amount of services Amarex performed for us for which it
has not already been paid and to arrange for payment of that amount.
We have entered into agreements with some of our creditors providing for
payment of our obligations to them over extended periods of time. We will have
to secure additional financing to meet those payment obligations.
7
PART II
Item 5. MARKET FOR THE REGISTRANT'S COMMON EQUITY AND RELATED STOCKHOLDER
MATTERS
Market Information
Our common stock commenced trading on January 19, 1996 under the symbol
"ORTC." The common stock traded on the Nasdaq SmallCap market until August 2002,
when it became delisted from the SmallCap market and commenced trading on the
National Association of Securities Dealers' Bulletin Board, where it presently
trades under the symbol "ORTC.OB." The following table sets forth the high and
low sales prices of the common stock as reported by Nasdaq and the Bulletin
Board for each full quarterly period within the two most recent fiscal years.
HIGH LOW
----- -----
Fiscal Year Ended December 31, 2001
First Quarter $8.75 $5.81
Second Quarter 6.98 5.75
Third Quarter 7.75 6.00
Fourth Quarter 6.94 4.45
Fiscal Year Ended December 31, 2002
First Quarter $6.99 $4.96
Second Quarter 5.05 1.50
Third Quarter 2.00 0.30
Fourth Quarter 0.54 0.27
8
Security Holders
To the best of our knowledge, at March 7, 2003, there were 139 record
holders of our common stock. We believe there are more than 1,000 beneficial
owners of our common stock whose shares are held in "street name."
Dividends
We have not paid and have no current plans to pay dividends on our common
stock.
Recent Sales of Unregistered Securities
In our quarterly report on Form 10-Q for the three month period ended
September 30, 2002, in a registration statement we filed with the Securities and
Exchange Commission which became effective January 31, 2003, and in our proxy
statement for our stockholders meeting held on February 11, 2003, we described a
series of private placements arranged by H.C. Wainwright & Co., Inc. in which we
received gross proceeds of $8.2 million. At the conclusion of those series of
financings we issued, in November and December of 2002, to the investors in
those private placements, 938.2742 shares of our Series B convertible preferred
stock, 13,135,858 shares of our common stock (including 3,753,116 shares which
were dividends payable on our Series B convertible preferred stock, which
dividends we can pay in our common stock and which dividends for the first year
were paid in advance), and warrants to purchase an additional 10,076,579 shares
of our common stock, of which warrants to purchase 5,429,891 shares are
exercisable at $1.50 per share, and warrants to purchase 4,691,386 shares are
exercisable at $2.00 per share. In November 2002, in addition to cash
compensation we also granted to H.C. Wainwright & Co., Inc. for its services in
arranging such Series B financing, and to Wainwright's designees, warrants to
purchase 1,300,000 shares of our common stock, of which warrants to purchase
800,000 shares were exercisable at $0.001 per share, and of which warrants to
purchase 500,000 shares are exercisable at $1.50 per share. The warrants to
purchase 800,000 shares at an exercise price of $0.001 per share were
exercised in December 2002 and January 2003 and as a result we issued an
additional 797,227 shares of our common stock to the holders of those warrants.
The 797,227 shares were 2,773 shares less than the 800,000 shares issuable upon
exercise of those warrants because of cashless exercise provisions in those
warrants which were utilized by all except one of the holders.
In February 2003 we received additional gross proceeds of $2 million from
five of the investors who had purchased our Series B convertible preferred stock
in November and December 2002, and from one new investor. We issued to such six
investors 200 shares of our Series B convertible preferred stock, 2,923,077
shares of our common stock (including 923,077 shares of our common stock
constituting the first year's dividends on such 200 shares of Series B
convertible preferred stock, which dividends were paid in advance) and warrants
to purchase an additional 2,000,000 shares of our common stock, of which
warrants to purchase 1,000,000 shares are exercisable at $1.50 per share and
warrants to purchase the other 1,000,000 shares are exercisable at $2.00 per
share. In March 2003, in addition to cash compensation, we also granted to
Wainwright for its services in arranging such February 2003 Series B financing,
and to one designee of Wainwright's, warrants to purchase an aggregate of
376,923 shares of our common stock, exercisable at $0.001 per share.
9
Each share of the Series B preferred stock is convertible into so many
shares of our common stock as determined by dividing the $10,000 liquidation
preference amount of one Series B preferred share by the conversion price. There
is a fixed conversion price and an alternative conversion price. The fixed
conversion price is $1.00 per share. After February 1, 2003, the holders of the
Series B preferred stock may elect an alternative conversion price, equal to 90%
of the average of the five lowest volume weighted average prices for our common
stock during the twenty trading days immediately prior to conversion. At no time
will the alternative conversion price be less than $0.25 per share. The
certificate of designations of the relative rights and preferences of the Series
B convertible preferred stock provides for customary adjustments to the
conversion price in the event of stock splits, combinations, dividends,
distributions, reclassification and other corporate events. If we issue or sell
any additional shares of common stock at a price per share less than $0.50, or
without consideration, or options or warrants to purchase, or other securities
convertible into, shares of our common stock, in effect giving the holders of
those options, warrants or convertible securities the right to purchase our
common stock at a price per share less than $0.50, the fixed conversion price
will be reduced (except in certain specified events, some of which would also
increase the alternative conversion price to $1.00) to a price equal to the
consideration per share paid or payable for such additional shares of common
stock, and the number of shares of our common stock into which the Series B
preferred stock can be converted will be proportionately increased.
Each holder of Series B preferred stock is entitled to receive dividends at
the rate of 12% of the Series B preferred stock's stated $10,000 per share
liquidation preference, payable by us semi-annually and at our option in either
cash or shares of our common stock that have been registered pursuant to an
effective registration statement. The formula for determining the number of
shares of our common stock to be paid as a dividend on each Series B preferred
share is the number equal to the quotient of (i) the dividend payment divided by
(ii) the conversion price.
The relative rights and preferences of our Series B convertible preferred
stock are described in greater detail in our prospectus dated January 21, 2003,
which can be viewed on the SEC's internet site, http://www.sec.gov.
All of the purchasers of our Series B convertible preferred stock
represented to us that they were "accredited investors" as such term is defined
in the rules promulgated by the Securities and Exchange Commission. The sale of
such Series B convertible preferred stock, the issuance of such common stock and
the grant of such warrants, in our Series B financings, were all exempt from the
registration requirements of the Securities Act of 1933 (the "Act") pursuant to
Section 4(2) of the Act and Regulation D promulgated under the Act because such
sales did not involve any public offering.
10
During the fourth quarter of 2002 we granted to 12 employees (including
four executive officers), two non-employee directors and two consultants,
options both under and outside our Employee Stock Option Plan, to purchase an
aggregate of 4,400,500 shares of our common stock, at exercise prices ranging
from $0.30 to $0.45 per share. The grant of such options was exempt from the
registration requirements of the Act pursuant to the provisions of Section 4(2)
thereof because such option grants did not involve any public offering and
because such option grants did not constitute sales of securities.
11
Item 6. Selected Financial Data
The following selected financial data are derived from the Company's financial
statements and should be read in conjunction with, and are qualified in their
entirety by, the financial statements and related notes included in Item 8 and
Management's Discussion and Analysis included elsewhere in this Annual Report:
Cumulative from
March 12, 1991
Statement of operations data (inception) to
December 31,
Years Ended December 31, 1998 1999 2000 2001 2002 2002
----------- ------------ ------------ ------------ ------------ ---------------
Product revenue $ -- $ -- $ -- $ 21,890 $ 243,775 $ 265,665
----------- ------------ ------------ ------------ ------------ ------------
Expenses
Research and development 1,933,877 3,106,908 4,191,317 4,283,038 3,147,515 21,195,907
Rent 252,397 473,010 535,443 589,238 683,116 2,862,651
Consulting 908,495 834,180 838,383 1,413,153 490,826 5,717,341
Personnel 4,060,629 3,742,632 4,763,662 6,605,630 6,440,959 29,390,319
General and administrative 1,725,201 2,152,968 2,297,769 2,671,887 2,781,896 14,784,581
Interest and other expense 104,605 99,522 89,712 536,070 7,281,104 8,300,610
Interest income (572,549) (368,711) (586,623) (191,749) (7,647) (2,257,096)
Loss on extinguishment of
debt and Series A
preferred shares -- -- -- -- 1,004,027 1,004,027
----------- ------------ ------------ ------------ ------------ ------------
8,412,655 10,040,509 12,129,663 15,907,267 21,821,796 80,998,340
----------- ------------ ------------ ------------ ------------ ------------
Net loss (8,412,655) (10,040,509) (12,129,663) (15,885,377) (21,578,021) (80,732,675)
Preferred stock dividends -- -- -- -- 1,125,934 1,125,934
----------- ------------ ------------ ------------ ------------ ------------
Net loss applicable to common
shareholders $(8,412,655) $(10,040,509) $(12,129,663) $(15,885,377) $(22,703,955) $(81,858,609)
=========== ============ ============ ============ ============ ============
Net loss per share of common stock
Basic and diluted $(1.43) $(1.51) $(1.37) $(1.64) $(2.01) $(15.54)
Weighted average common stock
outstanding
Basic and diluted 5,878,971 6,634,874 8,847,295 9,691,608 11,305,956 5,269,187
=========== ============ ============ ============ ============ ============
Balance sheet data 1998 1999 2000 2001 2002
- ------------------ ----------- ----------- ----------- ----------- ------------
Working capital/(deficiency) $ 9,368,901 $11,009,660 $ 7,966,410 $(2,529,159) $(17,787,545)
Total assets 12,391,039 15,011,645 11,719,760 4,038,601 3,698,366
Long-term debt, excluding current
maturities 1,152,180 1,044,857 912,489 6,768,983 828,498
Shareholders' equity/(deficit) 10,390,759 12,370,720 9,392,325 (6,304,972) (15,801,132)
12
Item 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS
OF OPERATIONS
The following discussion should be read in conjunction with our financial
statements and notes thereto. This discussion may be deemed to include
forward-looking statements.
Forward Looking Information May Prove Inaccurate
This Report on Form 10-K contains certain forward looking statements and
information relating to Ortec, that are based on the beliefs of management, as
well as assumptions made by and information currently available to us. When used
in this document, the words "anticipate," "believe," "estimate," and "expect"
and similar expressions, as they relate to Ortec, are intended to identify
forward looking statements. Such statements reflect our current views with
respect to future events and are subject to certain risks, uncertainties and
assumptions, including those described in this discussion and elsewhere in this
Annual Report on Form 10-K. Should one or more of these risks or
uncertainties materialize, or should underlying assumptions prove incorrect,
actual results may vary materially from those described herein as anticipated,
believed, estimated or expected. We do not intend to update these
forward-looking statements.
The following discussion should be read in conjunction with our financial
statements and notes thereto. This discussion may be deemed to include
forward-looking statements.
General
Since Ortec's inception we have been principally engaged in the research and
development of our tissue engineered skin regeneration product, for use in the
treatment of chronic and acute wounds, such as venous and diabetic skin ulcers,
and autograft donor site wounds for burn victims. We call our product OrCel'TM'
and in June 2001 we filed a trademark application for such name with the United
States Patent and Trademark Office.
In February 2001, we received FDA approval to make commercial sales of OrCel for
use on patients with recessive dystrophic epidermolysis bullosa, followed by FDA
approval in September 2001 for use of the product in the treatment of donor site
wounds in burn patients. With these approvals, though we are still a development
stage enterprise, in December 2001 we began commercial sales of our product,
generating revenues of $22,000 and $244,000 in 2001 and 2002, respectively.
During 2002, we engaged a sales force organization to actively pursue the sales
of our product, but due to a reduction in anticipated financing, we had to
curtail these activities in the second half of the year.
From inception to date, we have incurred cumulative net losses of approximately
$81.9 million. We expect to continue to incur substantial losses through 2004,
due to continued spending on research and development programs, the funding
of clinical trials and regulatory activities and the increased costs of
manufacturing, marketing and sales, distribution and administrative activities.
13
We are currently conducting a pivotal clinical trial using OrCel in the
treatment of venous stasis ulcers. Venous stasis ulcers are open lesions on the
legs, which result from the poor circulation of blood returning from the legs to
the heart. As of March 14, 2003, we have enrolled over 80 patients to
participate in the pivotal clinical trial and we are anticipating a total
enrollment of 102 patients to complete the trial. We expect to complete the
venous stasis pivotal clinical trials during the second quarter of 2003, with
submission of the FDA filing in September 2003. We anticipate obtaining FDA
approval early in 2004 for the use of our OrCel product in the treatment of
venous stasis ulcers.
In June 2002, we received approval from the FDA to initiate a pivotal clinical
trial using OrCel in the treatment of diabetic foot ulcers. Diabetic ulcers are
open sores that remain after the destruction of surface tissue. We have deferred
the implementation of the diabetic foot ulcers pivotal clinical trial and expect
to resume this trial in the second half of 2003 dependent on obtaining
sufficient additional financing, with FDA approval anticipated by the end of
2004.
We are investigating and currently are in discussions with a third party
manufacturer for the production of OrCel. If these discussions are successful,
we will be able to produce the large quantities of OrCel that will be required
upon the anticipated receipt of FDA approval for the sale of our product for use
in the treatment of patients with venous stasis ulcers. If we conclude an
agreement with the third party manufacturer, we will be able to defer or
terminate the costlier plan of constructing our owned manufacturing facility. We
are also concurrently in the process of evaluating various sales and marketing
collaborative arrangements.
We anticipate that future revenues and results of operations may continue to
fluctuate significantly depending on, among other factors, the timing and
outcome of applications for additional regulatory approvals, our ability to
successfully manufacture, market and distribute OrCel and/or the establishment
of collaborative arrangements for the manufacturing, marketing and distribution
of our product. We anticipate that our operating activities will result in
substantial net losses through 2004.
Critical Accounting Estimates
Revenue Recognition. Revenues from sales are recognized upon shipment of product
to customers.
Research and Development Costs. As we are still engaged in clinical trials of
our product and remain a development stage enterprise, the cost of producing
product for clinical trials and for sale, is included in Research and
Development costs. Additionally, all research and development costs, including
consulting and personnel costs, relating to products under development, are
expensed as incurred.
14
Long Term Obligations. We account for our Revenue Interest Assignment Agreement
in a manner similar to that of debt and provide for interest to reflect the
estimated cost of the funds anticipated under the terms of the agreement.
Pursuant to the default provisions under the agreement, interest is accrued at
30% per annum. At such time when the default provisions are no longer
applicable, interest will be accrued based upon the expected level of future
revenues, which may result in a lower imputed interest rate, with potential
material financial impact.
Impact of recently issued accounting pronouncements
On April 30, 2002, the Financial Accounting Standards Board (the FASB) issued
SFAS No.145, "Rescission of FASB Statements No.4, 44 and 64, Amendment of SFAS
No.13 and Technical Corrections". SFAS No.145 rescinds Statement No.4, which
requires all gains and losses from extinguishments of debt to be aggregated and,
if material, classified as an extraordinary item, net the related income tax
effect. Upon adoption of SFAS No.145, companies will be required to apply the
criteria in APB Opinion No.30, "Reporting the Results of Operations-Reporting
the Effects of Disposal of a Segment of a Business, and Extraordinary, Unusual
and Infrequently Occurring Events and Transactions" in determining the
classification of gains and losses resulting from the extinguishment of debt.
SFAS No.145 is effective for fiscal years beginning after May 15, 2002. We are
currently evaluating the requirements and impact of the statement on our results
of operations and financial position.
On July 30, 2002, the FASB issued SFAS No.146, "Accounting for Costs Associated
with Exit or Disposal Activities". The standard requires companies to recognize
costs associated with exit or disposal activities when they are incurred, rather
than at a date of a commitment to an exit or disposal plan. Example of costs
covered by the standard include lease termination costs and certain employee
severance costs that are associated with a restructuring, discontinued
operations, plant closing, or other exit or disposal activity. SFAS No.146 is to
be applied prospectively to exit and disposal activities initiated after
December 31, 2002. We will apply the provisions of this statement prospectively
to disposal activities commencing after December 31. 2002.
In December 2002, the FASB issued SFAS No.148, "Accounting for Stock Based
Compensation - Transition and Disclosure, an amendment of FASB Statement
No.123". This statement requires companies to reflect the fair market value of
employee stock based compensation in their results of operations as an
additional expense or disclose the pro-forma impact of this adjustment to net
income and earnings per share, in the notes to the financial statements. The
Company has elected to continue to account for its stock-based compensation
under the rules of APB Opinion No.25, with footnote disclosure, as required by
SFAS No.148.
Results of Operations
Year Ended December 31, 2002, and December 31, 2001.
15
Revenues
We earned revenues of approximately $244,000 in 2002, and $22,000 in 2001 from
commercial shipments of products to customers. Sales to commercial customers
began in December 2001, and were curtailed in the second half of 2002.
Expenses
Expenses increased by approximately $5.9 million in 2002, from approximately
$15.9 million in 2001 to $21.8 million in 2002. Interest, which primarily
consisted of non-cash charges relating to the preferred stock and debentures
financings, accounted for $6.7 million of this increase, while the loss
on extinguishment of debt represented $1.0 million of the increase. Other
expenses incurred in 2002, decreased by $1.8 million, compared with 2001.
Research and Development. These expenses decreased by approximately $1.1
million, from $4.3 million in 2001 to $3.2 million in 2002. Additionally, 2001
costs included a $0.4 million credit to expenses as a result of an insurance
recovery for damaged Orcel, which costs were incurred in 2000. All other
research and development costs decreased by $1.5 million in 2002, compared with
2001. This decrease in research and development expenses was due to the fact
that the costs incurred in 2002 included only one clinical trial, the venous
ulcer pivotal trial, whereas in 2001 there were three trials conducted and
concluded, the donor site pivotal trial, and the venous and diabetic ulcers
pilot trials. We expect to conclude the venous ulcer pivotal trial in 2003.
Personnel. Personnel costs decreased by approximately $.2 million from $6.6
million in 2001 to $6.4 million in 2002. Personnel costs initially increased in
the first half of 2002 due to the additional personnel required to conduct and
manage clinical trial programs, to manufacture the increased quantity of product
required by our clinical trial programs and for commercial sales and to initiate
our sales and marketing program for our FDA approved products. In July 2002,
management implemented a cost reduction plan and deferred the implementation of
the diabetic clinical trial, as well as, reduced production of product for
commercial sales, which resulted in significant reductions in personnel costs in
the second half of 2002.
Consulting. These fees decreased by $.9 million from $1.4 million in 2001 to $.5
million in 2002. This was due to the increased costs in 2001 related to the
specific requirements for concluding the clinical trials for donor site wounds
and FDA submissions, noted above, as well as, the costs of conducting the pilot
clinical trials for venous leg stasis and diabetic foot ulcers. In 2002, only
the costs of beginning the pivotal clinical trials for venous leg stasis ulcers
were incurred.
General and Administrative. These expenses increased by $.1 million from $2.7
million in 2001 to $2.8 million in 2002. The increase in 2002 was primarily due
to increased marketing expenses incurred early in the year, as we prepared for
commercial sales of our product. As noted above, the decision to reduce fresh
OrCel production in the third quarter resulted in a curtailment of marketing
expense in the second half of the year. In 2002, we also incurred
16
higher expenses, as we continued our intense financing efforts. These increases
were partially offset by a reduction of travel expenses in 2002, as we focused
on reducing our overall spending.
Rent. This expense increased by $.1 million in 2002 compared with 2001,
primarily due to the charges incurred for the New Jersey leases in 2002, which
expense was not incurred in 2001.
Interest Expense. Interest expense increased by $6.7 million, from $.5 million
in 2001 to $7.2 million in 2002. This increase was due to the imputed non-cash
interest resulting from the convertible debenture and convertible preferred
financings, which occurred in 2002. Interest of $3.6 million was recorded as a
result of these financings, $.2 million in coupon rate interest on the
debentures and $3.4 million recorded as the fair market value of the conversion
features and warrants issued with the financings. Additionally, non-cash
interest of $3.5 million was accrued in 2002, relating to the Paul Capital
Royalty obligation, as compared to $.5 million in 2001.
Interest Income. Interest income declined by approximately $.2 million in 2002,
compared with 2001, primarily due to the smaller average cash balances
outstanding during 2002 compared with 2001.
Loss on extinguishment of debt and series A preferred shares. We incurred a loss
of $1.0 million due to the conversion of debt into preferred shares in 2002.
Year Ended December 31, 2001 and December 31, 2000.
Revenues
Ortec made its first commercial shipments of products to customers in December
2001, earning revenues from operations of approximately $22,000.
Expenses
Expenses increased by approximately $3.4 million in 2001 from approximately
$12.7 million in 2000 to approximately $16.1 million in 2001.
Personnel. Personnel costs increased by approximately $1.8 million to $6.6
million in 2001, compared with $4.8 million in 2000. This increased expense
resulted from the additional personnel required to conduct and manage the
clinical trial programs, to manufacture the product required by our clinical
trial programs and other research and development activities, to prepare for
manufacturing scale-up and marketing and an increase in corporate and
administrative expenses. During 2001, we conducted two pilot clinical trials,
concluded a pivotal clinical trial and the relevant FDA submissions. Based on
these trials and submissions, Ortec was granted two FDA approvals in 2001.
Consulting. These fees increased by $.6 million from $.8 million in 2000 to $1.4
million in 2001, primarily due to costs incurred in conducting the clinical
trials and FDA submissions, noted above, the development of a new cryopreserved
product and in hiring a marketing consultant.
17
Research and Development. These expenses increased by approximately $.1 million
to $4.3 million in 2001, compared with $4.2 million in 2000. The increase in
research and development expenses was primarily due to the costs of conducting
the venous and diabetic ulcers clinical trials, as well as research work
performed in the areas of cryopreservation and production cost reduction.
General and Administrative. These expenses increased by $.4 million from $2.3
million in 2000 to $2.7 million in 2001, due to increased marketing and legal
expenses incurred, as Ortec prepares for commercial sales of its product and
continues its financing activities. During 2001, the Company worked on and
entered into several significant agreements, including the Paul Capital Revenue
Interest Assignment agreement, the GE Capital Asset Financing agreement and the
Technology Center of New Jersey Lease agreement. We also investigated and
evaluated several potential corporate investment partners.
Interest Expense. Ortec incurred increased interest expense of $.4 million in
2001, compared with the expense incurred in 2000. On August 29, 2001, Ortec
entered into a Royalty Revenue Interest Assignment agreement with Paul Capital
and as part of this agreement, was entitled to receive $10.0 million in 2001.
$6.0 million of this amount was received in 2001 and the remaining $4.0 million
was received in January 2002. As of December 31, 2001, management anticipated
that the effective cost of these funds based on the anticipated revenue stream,
over the term of this agreement, which terminates in December 2011, may range
between 20% to 35% per annum and as such, approximately $455,000 in interest
expense had been accrued in 2001.
Interest Income. Interest income declined by approximately $395,000 from
$587,000 in 2000 to approximately $192,000 in 2001, primarily due to the smaller
average cash balances outstanding during 2001 compared with 2000.
Liquidity and Capital Resources
Since inception (March 12, 1991) through December 31, 2002, we have accumulated
a deficit of approximately $81.9 million and we expect to continue to incur
substantial operating losses through 2004. We have financed our operations
primarily through private placements of our common stock, preferred stock and
convertible debentures, our initial public offering and the exercise of our
publicly traded Class A warrants at the end of 1997. From inception to December
31, 2002, we received cash proceeds from the sale of common equity securities,
net of share issuance expenses, of approximately $49.0 million, we received net
proceeds from the issuance of debentures and preferred stock of $8.2 million,
and we have received a total of $10 million from the sale of a percentage
interest in our future revenues from the sale of our product in North America.
18
Subsequent to December 31, 2002, the Company has continued with its convertible
preferred stock financing and on February 26, 2003, closed on an additional $2.0
million investment in preferred equity.
For the year ended December 31, 2002, we used net cash for operating activities
of approximately $10.9 million. Cash used in operating activities resulted
primarily from our net loss of $21.6 million, offset by depreciation and
amortization of approximately $715,000, approximately $6.9 million of non-cash
interest expense, a loss on extinguishment of debt on series A preferred stock
of $1.0 million and an increase in accounts payable and accrued expenses of
approximately $1.4 million.
During the year ended December 31, 2002 we invested approximately $192,000 in
property, plant, equipment and patent application costs. In January 2002, we
received a $1,300,000 line of credit from GE Capital for equipment lease
financing, with which we financed $450,000 of additional purchases of fixed
assets. This line of credit was available for eligible manufacturing equipment
purchases in 2002.
We repaid $246,000 of our loans payable and long-term debt during the year ended
December 31, 2002. We received $4.0 million under our agreement with Paul
Capital Royalty Acquisition Fund, L.P. and $8.2 million from issuance of our
convertible debentures, notes and preferred stock financing through
H.C. Wainwright, as noted above. As a result of the aforementioned preferred
stock financing, common shares outstanding increased by 13.5 million shares, due
to the conversion of warrants granted and the issuance of common stock
dividends.
In December 2001, we entered into a ten-year lease with New Jersey Economic
Development Authority ("NJEDA") to lease approximately 58,000 square feet of
manufacturing and office space located in North Brunswick, New Jersey. On August
5, 2002, we reached an agreement with NJEDA to terminate the December 2001 lease
and enter into a new lease for approximately 26,000 square feet of manufacturing
and office space. The new lease began on August 1, 2002 and terminates on
December 31, 2005, with rental payments beginning in January 2003. A security
deposit of $623,000, which was paid by us on the original lease, has been
applied as a security deposit on the new lease. All construction costs advanced
by NJEDA for the renovation of the premises, approximately $420,000, has been
included as a construction allowance in the new lease and is reflected in the
rent base. Due to the lower level of financing received in 2002 than had
originally been planned, the Company is currently engaged in discussions with
the NJEDA to defer or terminate the lease entered into in August 2002. In the
event that we reach an agreement with the NJEDA to terminate the lease, the
security deposit of $623,000 may be partially or wholly utilized as part of the
termination settlement.
Under the August 29, 2001 agreement, as amended, in consideration for the
investment of $10.0 million, Paul Capital received 3-1/3% of end user revenues
from the sale of our products in the United States, Canada and Mexico. These
percentage payments may be further adjusted upward or downward, based on the
volume of net sales to end users of our products in
19
those three countries. As of December 31, 2002, we have provided for the
effective cost of the amounts received from Paul Capital at 30% per annum,
pursuant to default provisions of the agreement and we have accrued interest
accordingly. However, at such time when the default provisions are no longer
applicable, interest will be accrued based upon the expected level of future
revenues, which may result in a lower imputed interest rate, with potential
material financial impact. Under the August 29, 2001 agreement, as amended,
beginning on January 1, 2003, Paul Capital will be entitled to receive each year
advances from the first proceeds to us from end user sales of our products. The
agreement provides for quarterly and annual accountings between Paul Capital and
us for those advance payments, compared to amounts owed based on actual sales.
Such annual amounts Paul Capital will be able to draw in advance will range from
$.6 million in 2003, $1.0 million in 2004 to $7.5 million in 2005 and
thereafter.
At December 31, 2002, our liabilities exceeded the value of our assets and as
such, we were technically in default of the solvency requirement under the Paul
Capital agreement. Paul Capital is aware of this breech and based on our
discussions regarding this issue, has indicated to us that it presently does not
intend to exercise its option to require us to repurchase its revenue interest.
Additionally, in February 2003, Paul Capital amended its agreement with us,
restating and updating certain provisions of the original agreement. On February
26, 2003, Paul Capital invested an additional $500,000 in our Series B preferred
stock, in concurrence with this amendment.
In the event of a change in control of Ortec or upon the occurrence of certain
other events as defined in the agreement, Paul Capital has the option to put its
revenue interest back to us for an amount as provided in the agreement. Ortec
also has the option to repurchase Paul Capital's interest upon the occurrence of
a change in control of Ortec or a complete divestiture by us of our products,
for an amount provided in the agreement.
We have granted Paul Capital a security interest in all our United States
patents and trademarks relating to our technology for our product, to secure
payments we are required to make to Paul Capital, based on sales generated under
the Royalty Revenue Interest Assignment agreement, as described above.
The original agreement and modifications to the agreement terminate on December
31, 2011, unless terminated earlier by either party, as permitted by the terms
of the agreement.
On March 27, 2002, we engaged H.C. Wainwright & Co., Inc. an investment banking
firm, to act as our financial advisor in connection with raising capital for the
Company through debt and/or equity financing. Wainwright has assisted us in
raising financing of approximately $8.2 million in 2002 and has continued its
financing efforts on our behalf in 2003. On May 13, 2002, we secured the first
$2.3 million of this financing, in the form of 12% convertible debentures, which
was convertible into common shares. On June 28, 2002, $0.6 million of these
debentures were converted into Series-A convertible preferred stock. We also
issued 291,000 warrants to purchase common stock as part of this May 13, 2002
financing. On June 28, 2002, an additional $1.5 million of financing was
secured, which consisted of $1.2 million in Series A convertible preferred stock
and $.3 million in 12% convertible debentures. We also issued 655,000 stock
purchase warrants as part of the June 28, 2002 financing. In the third and
20
fourth quarters of 2002, we raised an additional $3.3 million in convertible
debentures and $1.1 million in convertible preferred stock.
On November 13 and December 13, 2002, the investors converted all their
outstanding convertible debentures and Series-A convertible preferred stock into
Series-B convertible preferred stock, thereby acquiring 938.2742 shares of
preferred shares, at a stated value of $9,382,742. In addition, these investors
were granted Series A warrants, to purchase 9,382,742 shares of the Company's
common stock at an exercise price of $.001. These Series-A warrants vested
immediately and were exercised immediately, upon grant. The investors were also
granted Series B-1 and Series B-2 warrants, which can be used to purchase
5,429,891 and 4,691,386 shares of common stock at an exercise price of $1.50 and
$2.00 per share, respectively. The Series B-1 and B-2 warrants are exercisable
nine and twelve months, respectively, after issue. The warrants previously
granted with the issuance of the convertible debentures and Series-A preferred
stock, were exchanged for Series B-1 warrants. In conjunction with this
preferred stock financing, the investors were also paid a common stock dividend,
whereby they were granted 3,753,116 shares of common stock.
The Series B preferred stock is convertible into common shares at any time at
the option of the investor, based on a fixed conversion rate of $1.00 or
commencing after February 1, 2003, based on an alternative conversion rate equal
to 90% of the average of the five lowest volume weighted average prices for the
common stock for the twenty trading days immediately prior to conversion,
subject to a floor price of $0.25. The fixed conversion rate may be adjusted
downward if the Company subsequently issues common stock at a purchase price
less than $0.50. In that event, the fixed conversion rate will be adjusted
downward to the price of the new issuance. Conversion is mandatory, upon the
occurrence of certain financial events, such as, beginning six months from the
date of issue, if the closing bid price of common shares exceeds $2.00 for a
period of 20 consecutive trading days, or if within nine months from the date of
issue, the Company completes a public offering, raising a minimum of $8 million.
The alternative conversion price is adjustable or cancelable under certain
circumstances, such as, in the event that the Company receives a licensing fee
and/or a strategic investment of at least $5.0 million, within six months of
closing, the alternative conversion rate is adjusted to the common share price
of the investment or is cancelled if the share price exceeds the fixed rate of
$1.00. If within six months from date of issue, the Company receives a licensing
fee with an upfront payment of at least $5.0 million, the alternative conversion
rate is adjusted to the quoted closing stock price on the day of the public
announcement or is cancelled if this closing price exceeds $1.00. Similarly, if
the Company completes a subsequent public or private financing of a least $5.0
million, within six months of closing, the alternative conversion rate is
adjusted to the closing price or the fixed rate of $l.00, if lower. Dividends
were paid in advance in common shares at the rate of 12% in the first year after
issue and will be paid semiannually in subsequent years, in either cash or
common shares, at the election of the Company, until at such time as the
preferred stock is converted to common shares. Along with the convertible
preferred stock, the Company also issued warrants to purchase common shares, as
noted above. The Series B-1 and B-2 warrants are redeemable by the Company at
$0.10 per share, twelve months and twenty-four months after issuance,
respectively, if the Company's common shares closes above $3.00 and $4.00,
respectively, for 15 consecutive trading days.
21
Our capital funding requirements will depend on numerous factors, including the
progress and magnitude of our research and development programs, pre-clinical
testing and clinical trials, the time involved in obtaining regulatory approvals
for commercial sale of our product to treat venous stasis and diabetic foot
ulcers, the cost involved in filing and maintaining patent claims, technological
advances, competitive and market conditions, our ability to establish and
maintain collaborative arrangements, our cost of manufacturing scale up and the
cost and effectiveness of commercialization activities and arrangements.
We have raised funds in the past through the public or private sale of equity
securities and debentures and through the agreement with Paul Capital. We will
need to raise additional funds in the future through public or private
financings, collaborative arrangements or from other sources. The success of
such efforts will depend in large part upon continuing developments in our
clinical trials and upon market conditions.
We require substantial funding to continue our research and development
activities, clinical trials, manufacturing, sales, distribution and
administrative activities. We believe that our cash and cash equivalents on hand
at December 31, 2002, (approximately $0.8 million) and the financing of $2.0
million received in February 2003, will enable us to continue our operations
until May 31, 2003. We are continuing our equity financing efforts with H.C.
Wainwright and we expect to raise an additional $5.0 million from investors,
some of whom have previously participated in the $10.2 million raised to date.
This will enable us to complete our venous clinical pivotal trial, file our PMA
with the FDA and execute on our plan to engage the services of a third party
manufacturer. Accomplishing these milestones will also enable us to raise an
additional $5.0 million in 2003 through other potential collaborative
arrangements with companies for sales, marketing and distribution of our product
and through other equity investments. Based on these efforts, management
believes that the Company will be able to continue its operations for at least
the next 12 months.
We continue to explore and, as appropriate, enter into discussions with other
companies regarding the potential for equity investment, collaborative
arrangements, license agreements or other funding programs with us, in exchange
for manufacturing, marketing, distribution or other rights to our product.
However, we can give no assurance that discussions with other companies will
result in any additional investments, collaborative arrangements, agreements or
other funding, or that the necessary additional financing through debt or equity
financing will be available to us on acceptable terms, if at all. Further, we
can give no assurance that any arrangements resulting from these discussions
will successfully reduce our funding requirements. If additional funding is not
available to us when needed, we may not be able to continue operations.
22
Item 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
Reference is made to the Financial Statements contained in this Form 10-K
report, setting forth the financial statements of Ortec International, Inc.,
together with the report of Grant Thornton LLP, dated March 31, 2003.
23
PART III
Item 10. DIRECTORS AND EXECUTIVE OFFICERS OF THE REGISTRANT
Directors and Executive Officers
Set forth below are the directors and executive officers of Ortec,
their respective names and ages, positions with Ortec, principal occupations and
business experiences during at least the past five years and the dates of the
commencement of each individual's term as a director and/or officer.
Name Age Position
- ---- --- --------
Steven Katz, Ph.D. 58 Chairman of the Board of Directors
Mark Eisenberg, M.D. 65 Senior Vice President, Research and
Development, and Director
Ron Lipstein 47 Chief Executive and Chief Financial Officer,
Vice Chairman of the Board of Directors,
Secretary and Treasurer
Costantin Papastephanou, Ph.D. 57 President
Steve Lilien, Ph.D. 55 Director
Allen I. Schiff, Ph.D. 57 Director
Gregory B. Brown, M.D. 49 Director
Directors
Steven Katz, one of our founders, has been a director since our inception
in 1991 and was elected Chairman of our Board of Directors in September 1994. He
has been employed by us since 1991. Dr. Katz has also been a professor of
Economics and Finance at Bernard M. Baruch College in New York City since 1972.
He has a Ph.D. in Finance and Statistics as well as an MBA and an MS in
Operations Research, both from New York University.
Dr. Mark Eisenberg, one of our founders, has been a director and Senior
Vice President since 1991. Dr. Eisenberg has also been a consultant to us since
1991. See "Certain Relationships and Related Transactions - Eisenberg Consulting
Agreement". He has been a physician in private practice in Sydney, Australia
since 1967. He is a member and co-founder of the dystrophic epidermolysis
bullosa clinic at the Prince of Wales Hospital for children in Sydney,
Australia. He has done extensive research on epidermolysis bullosa disease.
24
Ron Lipstein, one of our founders, has been the Secretary, Treasurer, Chief
Financial Officer and a director of Ortec since 1991. Mr. Lipstein was elected
Vice Chairman of our Board of Directors in January 2001 and as our Chief
Executive Officer in March 2003. He has been employed by us since 1991. Mr.
Lipstein is a certified public accountant.
Steven Lilien has been a director of Ortec since February 1998. He has been
chairman of the accounting department of Bernard M. Baruch College in New York
City for the past fifteen years and is currently the Weinstein Professor of
Accounting there. He is a certified public accountant and has a Ph.D. in
accounting and finance and an MS, both from New York University.
Allen I. Schiff has been a director of Ortec since June 2001. He has been
Director of the Field Study Program at Fordham University Graduate School of
Business since 1992. That program performs consulting projects for businesses
and charitable institutions including a number of major well-known business and
charitable entities. From 1985 through 1989 he was chairman of both the
undergraduate and the graduate accounting departments at Fordham University. He
has a Ph.D. in business administration and an MS in accounting, both from New
York University. He is a director and chairman of the audit committee of Data
Software and Systems, Inc., a publicly held company whose shares are listed on
Nasdaq and whose principal business is the development of compatible software
for use by utilities.
Gregory B. Brown has been a director of our Company since March 2003. Since
January 2003 Dr. Brown has been a partner at Paul Capital Investors and serves
as the director selected by Paul Capital Royalty Acquisition Fund, L.P., an
affiliate of Paul Capital Investors. Pursuant to our agreement with Paul Capital
Royalty Acquisition Fund, L.P., we are required to elect a person designated by
Paul Capital Royalty Acquisition Fund, L.P. as a director of Ortec. From 1997 to
2002 Dr. Brown served as a managing director of Adams, Harness & Hill, an
investment banking firm, and from April 2001 to December 2002 as head of its
Healthcare and co-head of investment banking. Prior to 1997 Dr. Brown was a
thoracic and vascular surgeon. He received a B.A. degree from Yale University,
an M.D. from Upstate Medical School and an M.B.A. from Harvard Business School.
All directors hold office until the next annual meeting of stockholders and
the election and qualification of their successors. Drs. Steven Lilien, Allen I.
Schiff and Gregory B. Brown are non-employee directors. For Dr. Steven Lilien's
services in 2002 as a director and as chairman of our audit committee, we
granted Dr. Lilien 7 year options to purchase 48,500 shares of common stock. For
his services in 2002 as a director and as a member of our audit committee, we
paid Dr. Schiff an aggregate of $3,000 and granted Dr. Schiff 7 year options to
purchase an aggregate of 20,000 shares of common stock. Such options were
granted under our Employee Stock Option Plan and are exercisable at prices
ranging from $0.30 to $0.60 per share. Dr. Gregory B. Brown was not a director
in 2002.
25
Executive Officers
Officers are elected annually by the Board of Directors and serve at the
discretion of the Board of Directors. Two of our executive officers, Steven Katz
and Ron Lipstein, are also members of our Board of Directors. Information with
regard to such persons is set forth above under the heading "Directors." The
remaining executive officer is Costantin Papastephanou, our President.
Costantin Papastephanou was employed by us in February 2001 as our
president. Prior to joining Ortec he was employed by Bristol Myers-Squibb for 30
years, the last 14 of which he was with Bristol Myers' Convatec, a multinational
ostomy and wound care management division. His last position at Convatec was as
president of the global chronic care division, where he was responsible for that
division's sales and marketing, clinical trials, research and development,
manufacturing, quality assurance and regulatory affairs. He holds a Ph.D. in
Biochemistry from University of Miami as well as a Master of Science in
Microbial Biochemistry from University of London.
The Committees
The Board of Directors has an Audit Committee, a Compensation Committee and
a Stock Option Committee. The Board of Directors does not have a Nominating
Committee and the usual functions of such committee are performed by the entire
Board of Directors.
Audit Committee. The functions of the Audit Committee include
recommendations to the Board of Directors with respect to the engagement of our
independent certified public accountants and the review of the scope and effect
of the audit engagement. The current members of the Audit Committee are Drs.
Lilien and Schiff.
Compensation Committee. The function of the Compensation Committee is to
make recommendations to the Board of Directors with respect to the compensation
of our executive officers, including salary, bonus and other incentives. The
current members of the Compensation Committee are Messrs. Katz, Eisenberg and
Lilien.
Stock Option Committee. The Stock Option Committee determines the
employees, (other than our executive officers), consultants and advisors, to
whom options should be granted under our Stock Option Plan and the number of
options to be granted to each such employee, consultant and advisor. The current
members of the Stock Option Committee are Messrs. Katz and Lipstein. The Board
of Directors determines any other persons (our executive officers and directors)
to whom options should be granted and the number of options to be granted to
each such person.
26
Attendance at Meetings
During 2002, the Board of Directors, Audit Committee, Compensation
Committee and Stock Option Committee each met or acted without a meeting
pursuant to unanimous written consent 7 times, 6 times, 1 time and 16 times,
respectively. In 2002 all of the directors attended all of the meetings of the
Board of Directors except for Dr. Lilien who attended six of the seven meetings.
Dr. Lilien attended all six meetings and Dr. Schiff attended three meetings of
the Audit Committee. Messrs. Katz, Eisenberg and Lilien all attended the one
meeting of the Compensation Committee and Messrs. Katz and Lipstein attended all
meetings of the Stock Option Committee.
Section 16(a) Beneficial Ownership Reporting Compliance
To the best of our knowledge, during 2002 the following individuals who
were executive officers and/or directors of Ortec did not file a Form 4 report
in time: Steven Katz, Mark Eisenberg and Costantin Papastephanou, once each, and
Ron Lipstein, Alain Klapholz, William Schaeffer, Steven Lilien and Allen Schiff,
twice each. To the best of our knowledge, all other Forms 3, 4 and 5 required to
be filed during 2002 were done so on a timely basis.
Item 11. EXECUTIVE COMPENSATION
The following table sets forth the compensation paid by us for our fiscal
years ended December 31, 2002, 2001 and 2000 to (i) our Chief Executive Officer;
(ii) our other executive officers; and (iii) up to two additional individuals
for whom disclosure would have been provided under the above clause (ii) but for
the fact that the individuals were not serving as executive officers at the end
of the last completed fiscal year (the "Named Officers").
27
SUMMARY COMPENSATION TABLE
--------------------------------------------- ------------
Long Term
Annual Compensation Compensation
--------------------------------------------- ------------
- -------------------------------------------------------------------------------------------------
Securities
Name and Other Annual Underlying
Principal Position Year Salary($) Bonus($) Compensation($) Options/SARs
- -------------------------------------------------------------------------------------------------
Steven Katz 2002 225,058 150,850 2,100,825
Chairman
2001 236,392 92,000 200,000
2000 209,807 94,605 9,000* 129,278
- ------------------------------------------------------------------------------------------------
Ron Lipstein 2002 201,115 150,850 2,100,825
CEO, Vice Chairman, Secretary,
Treasurer and CFO 2001 214,447 86,000 185,000
2000 179,712 78,105 9,000* 118,128
- ------------------------------------------------------------------------------------------------
Costantin Papastephanou 2002 205,784 115,000
President
2001 181,625 60,000
- ------------------------------------------------------------------------------------------------
Alain Klapholz 2002 162,884 100,000
Former Vice President
and former Director (1) 2001 170,604 20,000 60,000
2000 159,808 30,000 23,300
- ------------------------------------------------------------------------------------------------
William Schaeffer 2002 181,733 34,220
Former Chief Operating Officer (1)
2001 188,688 10,000
2000 167,308 17,000
- ------------------------------------------------------------------------------------------------
- ----------
* In lieu of health insurance.
(1) Mr. Klapholz resigned as our Vice President and as a member of our Board of
Directors in March 2003, and Mr. Schaeffer resigned as our Chief Operating
Officer on February 14, 2003.
Board Compensation
Drs. Steven Lilien and Allen I. Schiff were our only non-employee directors
in 2002. For Dr. Steven Lilien's services in 2002 as a director and as chairman
of our audit committee, we granted Dr. Lilien 7 year options to purchase 48,500
shares of common stock. For his services in 2002 as a director and as a member
of our audit committee, we paid Dr. Schiff an aggregate of $3,000 and granted
Dr. Schiff 7 year options to purchase an aggregate of 20,000 shares of common
stock. Such options were granted under our Employee Stock Option Plan and are
exercisable at prices ranging from $0.30 to $0.60 per share.
Option Grants in Last Fiscal Year
The following table sets forth certain information regarding options
granted during the fiscal year ended December 31, 2002 by us to the Named
Officers:
28
- ----------------------------------------------------------------------------------------------------------
Potential Realizable
Value at
Assumed Annual
Rates of Stock Price
Appreciation for
Individual Grants Option Term
- ----------------------------------------------------------------------------------------------------------
(a) (b) (c) (d) (e) (f) (g)
- ----------------------------------------------------------------------------------------------------------
Number of % of Total
Securities Options/SARs
Underlying Granted to Exercise or
Options/SARs Employees in Base Price Expiration
Name Granted Fiscal Year (1) ($/Share) Date 5% ($) 10% ($)
- ----------------------------------------------------------------------------------------------------------
Steven Katz 2,100,000 43.4 $0.35 11/11/09 $294,000 $693,000
825 * 5.95 1/3/09 1,997 4,653
- ----------------------------------------------------------------------------------------------------------
Ron Lipstein 2,100,000 43.4 0.35 11/11/09 294,000 693,000
825 * 5.95 1/3/09 1,997 4,653
- ----------------------------------------------------------------------------------------------------------
Costantin Papastephanou 25,000 0.5 0.30 11/7/09 3,000 7,000
50,000 1.0 1.00 7/15/04 20,500 47,500
40,000 0.8 6.05 1/15/09 98,400 229,600
- ----------------------------------------------------------------------------------------------------------
Alain Klapholz 50,000 1.0 0.30 11/7/09 3,000 7,000
50,000 1.0 0.60 8/13/09 12,000 28,500
- ----------------------------------------------------------------------------------------------------------
William D. Schaeffer(2) 10,000 0.2 0.30 11/7/09 3,000 7,000
15,431 0.3 0.31 12/5/05 823 1,743
8,789 0.2 1.00 7/15/04 879 1,846
- ----------------------------------------------------------------------------------------------------------
- ----------
* Less than one percent
(1) Options to purchase a total of 4,831,609 shares of common stock were
granted to our employees, including the Named Officers, during the fiscal
year ended December 31, 2002.
The following table sets forth certain information regarding options
exercised and exercisable during the fiscal year ended December 31, 2002 and the
value of the options held as of December 31, 2002 by the Named Officers. None of
the Named Officers exercised any options during the fiscal year ended December
31, 2002.
29
Aggregated Option Exercises In Last Fiscal Year
and Fiscal Year-End Option Value
Number of Securities Value of Unexercised
Underlying Unexercised In-the-Money Options
Options At Fiscal Year-End at Fiscal Year-End (1)($)
(#)
--------------------------- ---------------------------
Name Exercisable Unexercisable Exercisable Unexercisable
- ---- ----------- ------------- ----------- -------------
Steven Katz 2,710,853 0 $273,000 0
Ron Lipstein 2,658,953 0 273,000 0
Costantin Papastephanou 15,000 160,000 0 $4,500
Alain Klapholz 262,300 0 9,000 0
William D. Schaeffer 48,313 59,657 0 4,423
(1) The product of (x) the difference between $0.48 (the closing price of our
Common Stock at December 31, 2002, as reported by Nasdaq) and the exercise
price of the unexercised options, multiplied by (y) the number of
unexercised options.
Compensation Committee Interlock and Insider Participation
None of our executive officers serves as a member of the compensation
committee or on the board of directors of another entity, one of whose executive
officers serves on our Board of Directors.
The Compensation Committee of our Board of Directors determines
compensation policies applicable to our five executive officers. Messrs. Steven
Katz, Mark Eisenberg and Steven Lilien are the members of the Compensation
Committee. Mr. Katz is an executive officer of Ortec.
Item 12. SECURITY OWNERSHIP OF BENEFICIAL OWNERS AND MANAGEMENT
The following table sets forth information, as of March 21, 2003, based
upon information obtained from the persons named below, regarding beneficial
ownership of our common stock by (i) each person who is known by us to own
beneficially more than 5% of the outstanding shares of our common stock, (ii)
each of our directors, (iii) each of the Named Officers, and (iv) all of our
executive officers and directors as a group.
30
Amount and Percentage of
Name and Address Nature of Beneficial Outstanding
of Beneficial Owner Ownership** Shares Owned**
- ------------------------------------------------------------------------------
Steven Katz* 2,902,915(1) 9.92
- ------------------------------------------------------------------------------
Mark Eisenberg* 598,500(2) 2.25
- ------------------------------------------------------------------------------
Ron Lipstein* 2,881,224(3) 9.86
- ------------------------------------------------------------------------------
Alain Klapholz* 548,906(4) 2.05
- ------------------------------------------------------------------------------
Costantin Papastephanou* 154,250(5) ***
- ------------------------------------------------------------------------------
William D. Schaeffer 2,500 ***
1 Saucon Valley Court
Skillman, NJ 08558
- ------------------------------------------------------------------------------
Steven Lilien 55,525(6) ***
19 Larchmont Street
Ardsley, NY 10502
- ------------------------------------------------------------------------------
Allen I. Schiff 27,500(7) ***
Fordham University
Graduate School of Business
113 West 60th Street
New York, NY 10023
- ------------------------------------------------------------------------------
Gregory B. Brown 0
140 E. 45th Street, 44th Floor
New York, NY 10017
- ------------------------------------------------------------------------------
Pequot Capital Management, Inc. 9,573,645(9)(10) 29.75
5000 Nyala Farm Road
Westport, CT 06880
- ------------------------------------------------------------------------------
DMG Advisors LLC 9,523,994(9)(10) 28.35
53 Forest Avenue, Suite 202
Old Greenwich, CT 06870
- ------------------------------------------------------------------------------
Sargon Capital International Fund Ltd. 9,315,524(9)(10) 28.87
6 Louis Drive
Montville, NJ 07045
- ------------------------------------------------------------------------------
SDS Merchant Fund L.P. 13,884,087(9)(10) 37.73
53 Forest Avenue, Suite 201
Old Greenwich, CT 06870
- ------------------------------------------------------------------------------
Stonestreet Limited Partnership 7,960,480(10) 23.07
c/o Canaccord Capital Corp.
32 Bay Street, Suite 1250
Toronto, ON M5H4A6
- ------------------------------------------------------------------------------
Paradigm Group 1,483,693(9)(10) 5.37
3000 Dundee Road, Suite 105
Northbrook, IL 60062
- ------------------------------------------------------------------------------
All officers and directors as a group 7,171,320(1-8) 22.32
(eight person)
- ------------------------------------------------------------------------------
* The address of these persons is at Ortec's offices, 3960 Broadway, New
York, NY 10032.
** The number of shares of common stock beneficially owned by each person or
entity is determined under rules promulgated by the Securities and Exchange
Commission. Under such rules, beneficial ownership includes any shares as
to which the person or entity has sole or shared voting power or investment
power. Included among the shares owned by such person are any
31
shares which such person or entity has the right to acquire within 60 days
after March 21, 2003. Unless otherwise indicated, each person or entity
referred to above has sole voting and investment power with respect to the
shares listed. The inclusion herein of any shares deemed beneficially owned
does not constitute an admission of beneficial ownership of such shares.
*** Less than 1%, based upon information available to us.
1. Does not include shares owned by Dr. Katz's children, their spouses and his
grandchildren. Dr. Katz disclaims any beneficial interest in such shares.
Includes 2,710,853 shares issuable to Dr. Katz upon his exercise of
outstanding options and warrants.
2. Includes 2,500 shares issuable to Dr. Eisenberg upon his exercise of
outstanding options.
3. Includes 33,600 shares owned by Mr. Lipstein's minor children. Mr. Lipstein
disclaims any beneficial interest in such 33,600 shares. Also includes
2,658,953 shares issuable to Mr. Lipstein upon his exercise of outstanding
options and warrants.
4. Includes 24,000 shares owned by Mr. Klapholz' minor children. Mr. Klapholz
disclaims any beneficial interest in such shares. Also includes 262,300
shares issuable to Mr. Klapholz upon his exercise of outstanding options.
5. Includes 152,500 shares issuable to Mr. Papastephanou upon his exercise of
outstanding options.
6. Includes 55,125 shares issuable to Dr. Lilien on his exercise of
outstanding options.
7. All 27,500 shares are issuable to Dr. Schiff on his exercise of outstanding
options.
8. Does not include 30,769 shares of common stock and 50 shares of Series B
convertible preferred stock which are convertible into shares of common
stock, held by Paul Capital Royalty Acquisition Fund, L.P. Dr. Brown was
selected by Paul Capital Royalty Acquisition Fund, L.P. to serve as a
director of Ortec pursuant to Ortec's agreement giving Paul Capital Royalty
Acquisition Fund, L.P. the right to name one director.
9. Shares held by investment funds. These have sole or shared investment
and/or voting power for these shares.
10. Includes the following number of shares of Series B convertible preferred
stock and assuming the conversion of such preferred shares into the
following number of shares of our common stock, which is determined by
dividing the liquidation preference amount of $10,000 per share by an
assumed conversion price of $0.25.
32
Number of Shares of Shares of Common
Series B Convertible Stock Assuming
Preferred Stock Conversion
-------------------- ----------------
Pequot Capital Management Fund, Inc. 140.8146 5,632,584
DMG Advisors LLC 176.1422 7,045,688
Sargon Capital International Fund Ltd. 171.9399 6,877,596
SDS Merchant Fund L.P. 256.2010 10,248,040
Stonestreet Limited Partnership 199.0120 7,960,480
Paradigm Group 27.4758 1,099,032
Equity Compensation Plan Information
The table below sets forth the following information as of the fiscal year
ended December 31, 2002 for (i) all compensation plans previously approved by
our stockholders and (ii) all compensation plans not previously approved by our
stockholders, if any:
(a) the number of securities to be issued upon the exercise of
outstanding options, warrants and rights;
(b) the weighted-average exercise price of such outstanding options,
warrants and rights; and
(c) other than securities to be issued upon the exercise of such
outstanding options, warrants and rights, the number of
securities remaining available for future issuance under the
plans.
33
(c)
Number of
Securities Remaining
(a) (b) Available for Future
Number of Securities to Weighted-Average Issuance Under Equity
be Issued Upon Exercise Exercise Price of Compensation Plans
of Outstanding Options, Outstanding Options, (excluding securities
Plan Category(1) Warrants and Rights Warrants and Rights reflected in column (a))
- ---------------- ----------------------- -------------------- ------------------------
Equity Compensation 2,872,117 $5.73 127,883
Plans Approved by
Securityholders
Equity Compensation 3,874,832 $0.56 0
Plans Not Approved by
Securityholders
--------- -------
Total 6,746,949 127,883
(1) The only equity compensation plan approved by our stockholders is our Third
Amended and Restated 1996 Stock Option Plan. The equity compensation plans
that have not been approved by our stockholders consists of stock options
outside of that Stock Option Plan granted to our executive officers to
purchase 3,800,000 shares of our common stock at an exercise price of $0.35
per share, and warrants issued for services and to a lender whose loan is
secured by our equipment.
Item 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS
Termination of Employment Agreements
We have entered into agreements with Messrs. Katz, Lipstein and Alain
Klapholz that provide for payments to them in the event that their employment is
terminated by us, including "constructive termination" as defined in those
agreements. We will pay to such terminated individuals in the event it is Dr.
Katz or Mr. Lipstein an amount equal to 2.99 times, and in the event it is Mr.
Klapholz 1.99 times, the average annual compensation paid by us to such person
in the five tax years prior to termination of his employment. The agreements
with Messrs. Katz, Lipstein and Klapholz also provide that in the event of such
termination of employment, the expiration dates of all options and warrants
which have been granted to such persons and which expire less than three years
after such termination of employment, will be extended so that such options and
warrants expire three years after such termination of employment. The agreements
further provide that in the event of the death or disability of Messrs. Katz,
Lipstein or Klapholz, or the voluntary termination of Messrs. Katz' or
Lipstein's employment, and in certain events the voluntary termination of Mr.
Klapholz' employment, we will pay to such executive an amount equal to the
compensation received by such executive from us in the previous 12 months.
34
The Internal Revenue Code provides that in the event that payments to an
executive officer resulting from a change of control of a company exceeds three
times the average annual compensation paid by us to such executive officer in
the five year period prior to such change of control (a) such excess will not be
able to be deducted by us in calculating our income for income tax purposes and
(b) a special excise tax equal to 20% of such excess will have to be paid by the
executive officer receiving such excess payments. Such agreements are commonly
referred to as "golden parachutes." The agreements with Messrs. Katz, Lipstein
and Klapholz provide that we will pay such excise tax payable by such executive
officer, as well as income taxes payable by such executive officer as a result
of our payment of such excise tax.
One of our directors, Dr. Gregory Brown, was selected by Paul Capital
Royalty Acquisition Fund, L.P. as provided by an amendment in February 2003 of
an agreement between us and Paul Capital. In August 2001 and in 2002 we
originally entered into agreements with Paul Capital pursuant to which we agreed
to pay to Paul Capital 3 1/3% of the end user sales prices paid for our product
in the United States, Canada and Mexico through the period ending in 2011. As
security for the performance of our obligations to Paul Capital, we granted Paul
Capital a security interest in all of our U.S. patents, patent applications and
trademarks. If there are defaults on our part in our performance of our
agreements with Paul Capital, including defaults occasioned by events beyond our
control (such as our insolvency), and we are unable to pay Paul Capital the
large amounts required to be paid by us because of our default, Paul Capital may
foreclose its security interest in our U.S. patents, patent applications and
trademarks and it is most likely that in such event we will have to discontinue
our operations. In February 2003, Paul Capital purchased 50 shares of our Series
B convertible preferred stock, 30,769 shares of our common stock and warrants to
purchase an aggregate of 500,000 shares of our common stock, at exercise prices
of $1.50 per share for 250,000 shares and at $2.00 per share for the other
250,000 shares. The February 2003 amendments to our agreements with Paul Capital
provided, among other things, for (a) the election of one director designated by
Paul Capital, (b) the right of one observer (other than such director) selected
by Paul Capital to attend and observe all meetings of Ortec's Board of Directors
and (c) that after June 30, 2003 Ortec has to use its best efforts to have
independent directors who are acceptable to both Ortec and Paul Capital,
including the director designated by Paul Capital, as a majority of Ortec's
Board of Directors.
Item 14. CONTROLS AND PROCEDURES
(a) Evaluation of disclosure controls and procedures.
Our Principal Executive Officer and Principal Financial Officer, after
evaluating the effectiveness of our disclosure controls and procedures (as
defined in Exchange Act Rules 13a-14(c) and 15-d-14(c) as of a date within 90
days of the filing date of the Annual Report (the "Evaluation Date") have
concluded that as of the Evaluation Date, our disclosure controls and procedures
were adequate and effective to ensure that material information relating to us
would be made known to us and them by others within those entities, particularly
during the period in which this Annual Report was being prepared.
(b) Changes in internal controls.
35
There were no significant changes in our internal controls or in other
factors that could significantly affect our internal controls and procedures
subsequent to the Evaluation Date, nor any significant deficiencies or material
weaknesses in such internal controls and procedures requiring corrective
actions. As a result, no corrective actions were taken.
FORWARD LOOKING STATEMENTS
This Annual Report includes statements that are "forward-looking
statements" within the meaning of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934, as amended,
including statements regarding our expectations, hopes, beliefs, intentions or
strategies regarding the future, that are based on the beliefs of our
management, as well as assumptions made by and information currently available
to us. When used in this document, the words "anticipate," "believe,"
"estimate," and "expect" and similar expressions, as they relate to us are
intended to identify such forward-looking statements. Such statements reflect
the current views of our management with respect to future events and are
subject to certain risks, uncertainties and assumptions, including those
described in this annual report. Should one or more of these risks or
uncertainties materialize, or should underlying assumptions prove incorrect,
actual results may vary materially from those described herein as anticipated,
believed, estimated or expected. We do not intend to update these
forward-looking statements.
AVAILABILITY OF FORM 10-K
We will provide a copy of our annual report on Form 10-K for the year ended
December 31, 2002, filed with the Securities and Exchange Commission, including
our financial statements and the financial statement schedules, to any of our
stockholders and to any person holding our warrants or options to purchase
shares of our common stock, or other securities convertible into our common
stock, upon written request and without charge. Such written request should be
directed to Mr. Ron Lipstein, Secretary, at Ortec International, Inc., 3960
Broadway, New York, NY 10032.
36
PART IV
Item 15. EXHIBITS, FINANCIAL STATEMENT SCHEDULES AND REPORTS ON FORM 8-K
(a) Financial Statements and Financial Statement Schedules.
(i) Financial Statements:
See Index to Financial Statements.
(ii) Financial Statement Schedules
All financial statement schedules have been omitted since either (i)
the schedule or condition requiring a schedule is not applicable or (ii) the
information required by such schedule is contained in the Financial Statements
and Notes thereto or in Management's Discussion and Analysis of Financial
Condition and Results of Operation.
(b) Reports on Form 8-K.
On December 12, 2002, we filed a Current Report on Form 8-K reporting
our entering into the Termination of Employment Agreements with Messrs. Katz,
Lipstein and Klapholz, as described above under the heading "Certain
Relationships and Related Transactions - Termination of Employment Agreements."
Other than the foregoing, we did not file any report on Form 8-K in the fourth
quarter of 2002.
37
(c) Exhibits.
Exhibit No. Description
- ----------- -----------
3.1 Restated Certificate of Incorporation (1)
3.2 Amendment to Restated Certificate of Incorporation (2)
3.3 Amendment to Certificate of Incorporation adopted June 28, 2002,
being a Certificate of Designation of the Relative Rights and
Preferences of the Series A Convertible Preferred Stock (3)
3.4 Amendment to Certificate of Incorporation filed on August 26,
2002, being an Amended Certificate of Designation of the Relative
Rights and Preferences of the Series B Convertible Preferred
Stock (4)
3.5 By-Laws (5)
23. Consent of Grant Thornton LLP (2)
99.1 Certificate of Principal Executive Officer (2)
99.2 Certification of Principal Financial Officer (2)
- ----------
(1) Filed as an Exhibit to our Form 10-Q filed for the quarter ended September
30, 2001, and incorporated herein by reference.
(2) Filed herewith.
(3) Filed as an Exhibit to our Form 10-Q for the quarter ended June 30, 2002.
(4) Filed as an Exhibit to our Form 10-QA for the quarter ended September 30,
2002.
(5) Filed as an Exhibit to our Registration Statement on Form SB-2 (File No.
33-96090), or Amendment 1 thereto, and incorporated herein by reference.
38
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange
Act of 1934, the Registrant has duly caused this report to be signed on its
behalf by the undersigned thereunto duly authorized.
Dated: April 14, 2003 Ortec International, Inc.
By: /s/ Steven Katz
----------------------
Steven Katz, Ph.D.
Chairman
Pursuant to the requirements of the Securities Exchange Act of 1934, this
report has been signed below by the following persons on behalf of the
Registrant and in the capacities and on the dates indicated.
Signature Title Date
- --------- ----- ----
/s/ Steven Katz Chairman (Principal Executive Officer) April 14 2003
- --------------------
Steven Katz
/s/ Dr. Mark Eisenberg Senior Vice President, Research and April 14 2003
- --------------------- Development and Director
Dr. Mark Eisenberg
/s/ Ron Lipstein Vice Chairman, Chief Executive and April 14, 2003
- -------------------- Financial Officer, Secretary, Treasurer
Ron Lipstein and Director (Principal Financial
and Accounting Officer)
/s/ Steven Lilien Director April 14, 2003
- --------------------
Steven Lilien
/s/ Allen I. Schiff Director April 14, 2003
- --------------------
Allen I. Schiff
/s/ Gregory B. Brown Director April 14, 2003
- --------------------
Gregory B. Brown
39
CERTIFICATIONS
I, Steven Katz, certify that:
1. I have reviewed this annual report on Form 10-K of Ortec International, Inc.;
2. Based on my knowledge, this annual report does not contain any untrue
statement of a material fact or omit to state a material fact necessary to make
the statements made, in light of the circumstances under which such statements
were made, not misleading with respect to the period covered by this annual
report;
3. Based on my knowledge, the financial statements, and other financial
information included in this annual report, fairly present in all material
respects the financial condition, results of operations and cash flows of the
registrant as of, and for, the periods presented in this annual report;
4. The registrant's other certifying officer and I are responsible for
establishing and maintaining disclosure controls and procedures (as defined in
Exchange Act Rules 13a-14 and 15d-14) for the registrant and we have:
a) designed such disclosure controls and procedures to ensure that material
information relating to the registrant, including its consolidated
subsidiaries, is made known to us by others within those entities,
particularly during the period in which this annual report is being
prepared;
b) evaluated the effectiveness of the registrant's disclosure controls and
procedures as of a date within 90 days prior to the filing date of this
annual report (the "Evaluation Date"); and
c) presented in this annual report our conclusions about the effectiveness of
the disclosure controls and procedures based on our evaluation as of the
Evaluation Date;
5. The registrant's other certifying officer and I have disclosed, based on our
most recent evaluation, to the registrant's auditors and the audit committee of
the registrant's board of directors (or persons performing the equivalent
functions):
a) all significant deficiencies in the design or operation of internal
controls which could adversely affect the registrant's ability to record,
process, summarize and report financial data and have identified for the
registrant's auditors any material weaknesses in internal controls; and
b) any fraud, whether or not material, that involves management or other
employees who have a significant role in the registrant's internal
controls; and
6. The registrant's other certifying officer and I have indicated in this annual
report whether there were significant changes in internal controls or in other
factors that could significantly affect
internal controls subsequent to the date of our most recent evaluation,
including any corrective actions with regard to significant deficiencies and
material weaknesses.
Date: April 14, 2003
/s/ Steven Katz
----------------------------------------
STEVEN KATZ
Chairman and Principal Executive Officer
I, Ron Lipstein, certify that:
1. I have reviewed this annual report on Form 10-K of Ortec International, Inc.;
2. Based on my knowledge, this annual report does not contain any untrue
statement of a material fact or omit to state a material fact necessary to make
the statements made, in light of the circumstances under which such statements
were made, not misleading with respect to the period covered by this annual
report;
3. Based on my knowledge, the financial statements, and other financial
information included in this annual report, fairly present in all material
respects the financial condition, results of operations and cash flows of the
registrant as of, and for, the periods presented in this annual report;
4. The registrant's other certifying officer and I are responsible for
establishing and maintaining disclosure controls and procedures (as defined in
Exchange Act Rules 13a-14 and 15d-14) for the registrant and we have:
a) designed such disclosure controls and procedures to ensure that material
information relating to the registrant, including its consolidated
subsidiaries, is made known to us by others within those entities,
particularly during the period in which this annual report is being
prepared;
b) evaluated the effectiveness of the registrant's disclosure controls and
procedures as of a date within 90 days prior to the filing date of this
annual report (the "Evaluation Date"); and
c) presented in this annual report our conclusions about the effectiveness of
the disclosure controls and procedures based on our evaluation as of the
Evaluation Date;
5. The registrant's other certifying officer and I have disclosed, based on our
most recent evaluation, to the registrant's auditors and the audit committee of
the registrant's board of directors (or persons performing the equivalent
functions):
a) all significant deficiencies in the design or operation of internal
controls which could adversely affect the registrant's ability to record,
process, summarize and report financial data and have identified for the
registrant's auditors any material weaknesses in internal controls; and
b) any fraud, whether or not material, that involves management or other
employees who have a significant role in the registrant's internal
controls; and
6. The registrant's other certifying officer and I have indicated in this annual
report whether there were significant changes in internal controls or in other
factors that could significantly affect internal controls subsequent to the date
of our most recent evaluation, including any corrective actions with regard to
significant deficiencies and material weaknesses.
Date: April 14, 2003
/s/ Ron Lipstein
---------------------------
RON LIPSTEIN
Principal Financial Officer
Ortec International, Inc.
(a development stage enterprise)
INDEX TO FINANCIAL STATEMENTS
Page
----
Report of Independent Certified Public Accountants F-2
Financial Statements
Balance Sheets as of December 31, 2002 and 2001 F-3
Statements of Operations for the years ended December 31,
2002, 2001 and 2000, and for the cumulative period from
March 12, 1991 (inception) to December 31, 2002 F-5
Statement of Shareholders' Equity/(Deficit) for the cumulative
period from March 12, 1991 (inception) to
December 31, 2002 F-6
Statements of Cash Flows for the years ended December 31,
2002, 2001 and 2000, and for the cumulative period from
March 12, 1991 (inception) to December 31, 2002 F-11
Notes to Financial Statements F-14 - F-42
F-1
REPORT OF INDEPENDENT CERTIFIED PUBLIC ACCOUNTANTS
Board of Directors and Stockholders
Ortec International, Inc.
We have audited the accompanying balance sheets of Ortec International, Inc. (a
development stage enterprise) (the "Company") as of December 31, 2002 and 2001,
and the related statements of operations, shareholders' equity/(deficit) and
cash flows for each of the three years in the period ended December 31, 2002,
and for the period from March 12, 1991 (inception) to December 31, 2002. These
financial statements are the responsibility of the Company's management. Our
responsibility is to express an opinion on these financial statements based on
our audits.
We conducted our audits in accordance with auditing standards generally accepted
in the United States of America. 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 financial statements referred to above present fairly, in
all material respects, the financial position of Ortec International, Inc. at
December 31, 2002 and 2001, and the results of its operations and its cash flows
for each of the three years in the period ended December 31, 2002, and for the
period from March 12, 1991 (inception) to December 31, 2002, in conformity with
accounting principles generally accepted in the United States of America.
The accompanying financial statements have been prepared assuming that the
Company will continue as a going concern. As discussed in Note 1, the Company
incurred a net loss of $21,578,021 during the year ended December 31, 2002, and,
as of that date, the Company's current liabilities exceeded its current assets
by $17,787,545, its total liabilities exceeded its total assets by $15,801,132,
and the Company has a deficit accumulated in its development stage of
$81,858,609. These factors, among others, as discussed in Note 1 to the
financial statements, raise substantial doubt about the Company's ability to
continue as a going concern. Management's plans in regard to these matters are
also described in Note 1. The financial statements do not include any
adjustments that might result from the outcome of this uncertainty.
GRANT THORNTON LLP
New York, New York
March 31, 2003
F-2
Ortec International, Inc.
(a development stage enterprise)
BALANCE SHEETS
December 31,
ASSETS 2002 2001
----------- -----------
CURRENT ASSETS
Cash and cash equivalents $ 826,227 $ 854,025
Accounts receivable 15,324 21,890
Due from New Jersey Economic Development Authority 82,433
Other current assets 41,904 87,083
----------- -----------
Total current assets 883,455 1,045,431
PROPERTY AND EQUIPMENT, AT COST
Laboratory equipment 1,671,075 2,126,771
Office furniture and equipment 1,350,985 982,948
Leasehold improvements 1,567,513 1,367,784
----------- -----------
4,589,573 4,477,503
Less accumulated depreciation and amortization (3,207,977) (2,894,782)
----------- -----------
1,381,596 1,582,721
OTHER ASSETS
Patent application costs, net of accumulated
amortization of $279,037 in 2002 and
$213,105 in 2001 682,885 619,676
Deferred financing costs, net of accumulated
amortization of $7,933 in 2002 and $1,983 in 2001 78,207 57,517
Security deposit - New Jersey location 639,000 598,000
Other deposits and other assets 33,223 135,256
----------- ----------
$ 3,698,366 $ 4,038,601
=========== ===========
F-3
Ortec International, Inc.
(a development stage enterprise)
BALANCE SHEETS (continued)
December 31,
LIABILITIES AND
SHAREHOLDERS' EQUITY/(DEFICIT) 2002 2001
------------ ------------
CURRENT LIABILITIES
Accounts payable and accrued expenses $ 3,773,063 $ 2,451,133
Accrued compensation 274,253 223,393
Accrued professional fees 365,945 301,783
Capital lease obligation - current 142,620
Loan payable - current 155,578 143,505
Other obligations 13,959,541 454,776
------------ ------------
Total current liabilities 18,671,000 3,574,590
LONG-TERM LIABILITIES
Loan payable - noncurrent 613,405 768,983
Capital lease obligation - noncurrent 215,093
Other long-term obligations 6,000,000
COMMITMENTS AND CONTINGENCIES
SHAREHOLDERS' EQUITY/(DEFICIT)
Common stock, $.001 par value; authorized,
35,000,000 shares; 23,204,693 shares issued, 23,184,693 shares
outstanding, at December 31, 2002 and 9,711,608 shares issued, 9,691,608
outstanding, at December 31, 2001 23,205 9,712
Redeemable Convertible Preferred stock - Series B stated value $10,000
per share; authorized 1,000,000 shares;
938 shares issued and outstanding, at December 31, 2002,
liquidation preference at December 31, 2002 is $9,382,942 5,037,087
Additional paid-in capital 61,174,830 53,017,615
Deficit accumulated during the development stage (81,858,609) (59,154,654)
Treasury stock, at cost (20,000 shares at December 31, 2002 and 2001) (177,645) (177,645)
------------ ------------
(15,801,132) (6,304,972)
------------ ------------
$ 3,698,366 $ 4,038,601
============ ============
The accompanying notes are an integral part of these statements.
F-4
Ortec International, Inc.
(a development stage enterprise)
STATEMENTS OF OPERATIONS
Cumulative
from
March 12,
1991
Year ended December 31, (inception) to
------------------------------------------ December 31,
2002 2001 2000 2002
------------ ------------ ------------ --------------
Product revenue $ 243,775 $ 21,890 $ -- $ 265,665
------------ ------------ ------------ ------------
Expenses
Research and development 3,147,515 4,283,038 4,191,317 21,195,907
Rent 683,116 589,238 535,443 2,862,651
Consulting 490,826 1,413,153 838,383 5,717,341
Personnel 6,440,959 6,605,630 4,763,662 29,390,319
General and administrative 2,781,896 2,671,887 2,297,769 14,784,581
Interest and other expense 7,281,104 536,070 89,712 8,300,610
Interest income (7,647) (191,749) (586,623) (2,257,096)
Loss on extinguishment of debt
and series A preferred shares 1,004,027 -- -- 1,004,027
------------ ------------ ------------ ------------
21,821,796 15,907,267 12,129,663 80,998,340
------------ ------------ ------------ ------------
Net loss (21,578,021) (15,885,377) (12,129,663) (80,732,675)
Preferred stock dividends 1,125,934 -- -- 1,125,934
------------ ------------ ------------ ------------
Net loss applicable to common shareholders $(22,703,955) $(15,885,377) $(12,129,663) $(81,858,609)
============ ============ ============ ============
Net loss per share
Basic and diluted $(2.01) $(1.64) $(1.37) $(15.54)
====== ====== ====== =======
Weighted average shares outstanding
Basic and diluted 11,305,956 9,691,608 8,847,295 5,269,187
============ ============ ============ ============
The accompanying notes are an integral part of these statements.
F-5
Ortec International, Inc.
(a development stage enterprise)
STATEMENT OF SHAREHOLDERS' EQUITY/(DEFICIT)
Deficit
accumulated
Common stock Additional during the Total
------------------ Preferred paid-in development Treasury shareholders'
Shares Amount stock capital stage stock equity/(deficit)
--------- ------ --------- ----------- ----------- -------- ----------------
March 12, 1991 (inception) to
December 31, 1991
Issuance of stock
Founders 1,553,820 $1,554 $ (684) $ 870
First private placement ($.30 cash
per share) 217,440 217 64,783 65,000
The Director ($1.15 and $5.30 cash
per share) 149,020 149 249,851 250,000
Second private placement ($9.425 cash
per share) 53,020 53 499,947 500,000
Share issuance expenses (21,118) (21,118)
Net loss $ (281,644) (281,644)
--------- ------ ---------- ----------- -----------
Balance at December 31, 1991 1,973,300 1,973 792,779 (281,644) 513,108
Issuance of stock
Second private placement ($9.425
cash per share) 49,320 49 465,424 465,473
Stock purchase agreement with
the Director ($9.425 cash per
share) 31,820 32 299,966 299,998
Share issuance expenses (35,477) (35,477)
Net loss (785,941) (785,941)
--------- ------ ---------- ----------- -----------
Balance at December 31, 1992 2,054,440 2,054 1,522,692 (1,067,585) 457,161
Issuance of stock
Third private placement ($10.00
cash per share) 132,150 132 1,321,368 1,321,500
Stock purchase agreement with
Home Insurance Company ($9.00
cash per share) 111,111 111 999,888 999,999
Stock purchase agreement with
the Director ($9.425 cash per
share) 21,220 21 199,979 200,000
Shares issued in exchange for
commission ($10.00 value per
share) 600 1 5,999 6,000
Share issuance expenses (230,207) (230,207)
Net loss (1,445,624) (1,445,624)
--------- ------ ---------- ----------- -----------
Balance at December 31, 1993
(carried forward) 2,319,521 2,319 3,819,719 (2,513,209) 1,308,829
F-6
Ortec International, Inc.
(a development stage enterprise)
STATEMENT OF SHAREHOLDERS' EQUITY/(DEFICIT) (continued)
Deficit
accumulated
Common stock Additional during the Total
------------------ Preferred paid-in development Treasury shareholders'
Shares Amount stock capital stage stock equity/(deficit)
--------- ------ --------- ----------- ----------- -------- ---------------
(brought forward) 2,319,521 $2,319 $ 3,819,719 $(2,513,209) $ 1,308,829
Issuance of stock
Fourth private placement ($10.00 cash
per share) 39,451 40 397,672 397,712
Stock purchase agreement with Home
Insurance Company ($10.00 cash per
share) 50,000 50 499,950 500,000
Share issuance expenses (8,697) (8,697)
Net loss (1,675,087) (1,675,087)
--------- ------ ----------- ----------- -----------
Balance at December 31, 1994 2,408,972 2,409 4,708,644 (4,188,296) 522,757
Rent forgiveness 40,740 40,740
Net loss (1,022,723) (1,022,723)
--------- ------ ----------- ----------- -----------
Balance at December 31, 1995 2,408,972 2,409 4,749,384 (5,211,019) (459,226)
Initial public offering 1,200,000 1,200 5,998,800 6,000,000
Exercise of warrants 33,885 34 33,851 33,885
Fifth private placement ($6.49 cash per
share) 959,106 959 6,219,838 6,220,797
Share issuance costs (1,580,690) (1,580,690)
Stock options issued for services 152,000 152,000
Net loss (2,649,768) (2,649,768)
--------- ------ ----------- ----------- -----------
Balance at December 31, 1996 (carried
forward) 4,601,963 4,602 15,573,183 (7,860,787) 7,716,998
F-7
Ortec International, Inc.
(a development stage enterprise)
STATEMENT OF SHAREHOLDERS' EQUITY/(DEFICIT) (continued)
Deficit
accumulated
Common stock Additional during the Total
------------------ paid-in development Treasury shareholders'
Shares Amount Preferred stock capital stage stock equity/(deficit)
--------- ------ --------------- ----------- ------------ --------- ----------------
(brought forward) 4,601,963 $4,602 $15,573,183 $ (7,860,787) $ 7,716,998
Exercise of warrants 1,158,771 1,159 10,821,632 10,822,791
Share issuance costs (657,508) (657,508)
Stock options and warrants
issued for services 660,000 660,000
Net loss (4,825,663) (4,825,663)
--------- ------ ----------- ------------ ------------
Balance at December 31, 1997 5,760,734 5,761 26,397,307 (12,686,450) 13,716,618
Exercise of warrants 221,486 221 1,281,736 1,281,957
Stock options and warrants
issued for services 1,920,111 1,920,111
Sixth private placement 200,000 200 1,788,498 1,788,698
Warrants issued in Sixth
private placement 211,302 211,302
Share issuance costs (48,000) (48,000)
Purchase of 6,600 shares of
treasury stock (at cost) $ (67,272) (67,272)
Net loss (8,412,655) (8,412,655)
--------- ------ ----------- ------------ --------- ------------
Balance at December 31, 1998 6,182,220 6,182 31,550,954 (21,099,105) (67,272) 10,390,759
Exercise of warrants 14,103 14 14,089 14,103
Stock options and warrants
issued for services 64,715 64,715
Seventh private placement
($8.75 cash per share) 389,156 389 3,168,396 3,168,785
Warrants issued in Seventh
private placement 468,291 468,291
Eighth private placement
($5.50 cash per share) 1,636,364 1,637 8,998,365 9,000,002
Share issuance costs (619,908) (619,908)
Purchase of 9,100 shares
of treasury stock (at cost) (75,518) (75,518)
Net loss (10,040,509) (10,040,509)
--------- ------ ----------- ------------ --------- ------------
Balance at December 31, 1999
(carried forward) 8,221,843 8,222 43,644,902 (31,139,614) (142,790) 12,370,720
F-8
Ortec International, Inc.
(a development stage enterprise)
STATEMENT OF SHAREHOLDERS' EQUITY/(DEFICIT) (continued)
Deficit
accumulated
Common stock Additional during the Total
------------------ paid-in development Treasury shareholders'
Shares Amount Preferred stock capital stage stock equity/(deficit)
--------- ------ --------------- ----------- ------------ --------- ----------------
(brought forward) 8,221,843 $8,222 $43,644,902 $(31,139,614) $(142,790) $ 12,370,720
Exercise of options and
warrants 175,532 175 327,107 327,282
Stock options and warrants
issued for services 56,265 56,265
Ninth private placement
($15.00 cash per share) 66,667 67 999,938 1,000,005
Warrants issued in Ninth
private placement 23,000 23,000
Tenth private placement
($6.75 cash per share) 1,247,566 1,248 8,419,823 8,421,071
Share issuance costs (641,500) (641,500)
Purchase of 4,300 shares of
treasury stock (at cost) (34,855) (34,855)
Net loss (12,129,663) (12,129,663)
--------- ------ ----------- ------------ --------- ------------
Balance at December 31, 2000 9,711,608 9,712 52,829,535 (43,269,277) (177,645) 9,392,325
Stock options issued for
services 188,080 188,080
Net loss (15,885,377) (15,885,377)
--------- ------ ----------- ------------ --------- ------------
Balance at December 31, 2001 9,711,608 9,712 53,017,615 (59,154,654) (177,645) (6,304,972)
F-9
Ortec International, Inc.
(a development stage enterprise)
STATEMENT OF SHAREHOLDERS' EQUITY/(DEFICIT) (continued)
Deficit
accumulated
Common stock Additional during the Total
----------------- paid-in development Treasury shareholders'
Shares Amount Preferred stock capital stage stock equity/(deficit)
--------- ------ --------------- ----------- ------------- --------- ----------------
(brought forward) 9,711,608 $ 9,712 $53,017,615 $(59,154,654) $(177,645) $ (6,304,972)
Exercise of options and
warrants 357,227 357 357
Stock options and warrants
issued for services 113,060 113,060
Warrants issued with
convertible debentures 440,523 440,523
Warrants issued with
convertible redeemable
preferred stock 559,289 559,289
Convertible debenture
conversion benefit 1,042,663 1,042,663
Redeemable convertible
preferred stock
conversion benefit 1,097,886 1,097,886
Issuance of 938 shares of
preferred stock $ 9,382,742 9,382,742
Warrants issued and exercised
with preferred stock 9,382,742 9,383 (3,479,043) 3,476,998 7,338
Share issuance costs -
preferred stock (866,612) 304,615 (561,997)
Preferred stock dividends 3,753,116 3,753 1,122,181 (1,125,934) --
Net loss (21,578,021) (21,578,021)
---------- ------- ----------- ----------- ------------ ---------- -------------
Balance at December 31, 2002 23,204,693 $23,205 $ 5,037,087 $61,174,830 $(81,858,609) $(177,645) $(15,801,132)
========== ======= =========== =========== ============ ========== =============
The accompanying notes are an integral part of this statement.
F-10
Ortec International, Inc.
(a development stage enterprise)
STATEMENTS OF CASH FLOWS
Cumulative
from
March 12,
1991
Year ended December 31, (inception) to
------------------------------------------ December 31,
2002 2001 2000 2002
------------ ------------ ------------ --------------
Cash flows from operating activities
Net loss $(21,578,021) $(15,885,377) $(12,129,663) $(80,732,675)
Adjustments to reconcile net loss to net cash
used in operating activities
Depreciation and amortization 714,692 725,567 708,928 3,833,020
Amortization of deferred financing costs 323,225 323,225
Unrealized loss on marketable securities 11,404
Realized loss on marketable securities 5,250
Loss on sale of property and equipment 8,364 8,364
Non-cash stock compensation 113,060 188,080 56,265 3,154,231
Non-cash imputed interest 6,857,650 454,775 7,312,425
Loss on extinguishment of debt &
Series A preferred stock 1,004,027 -- 1,004,027
Purchases of marketable securities (19,075,122)
Sales of marketable securities 19,130,920
Changes in operating assets and liabilities
Accounts receivable 6,566 (21,890) (15,324)
Other current assets and other assets 188,645 (80,638) (87,177) 19,131
Accounts payable and accrued liabilities 1,436,952 1,634,233 (186,243) 4,441,589
------------ ------------ ------------ ------------
Net cash used in operating activities (10,924,840) (12,985,250) (11,637,890) (60,579,535)
------------ ------------ ------------ ------------
Cash flows from investing activities
Purchases of property and equipment, excluding
capital leases (63,460) (518,456) (551,630) (4,453,897)
Proceeds from sale of property and equipment 56,901 56,901
Payments for patent applications (129,140) (99,453) (90,363) (960,142)
Organization costs (10,238)
Deposits (702,924) 578 (731,273)
Purchases of marketable securities (594,986)
Sale of marketable securities 522,532
------------ ------------ ------------ ------------
Net cash used in investing activities (135,699) (1,320,833) (641,415) (6,171,103)
------------ ------------ ------------ ------------
F-11
Ortec International, Inc.
(a development stage enterprise)
STATEMENTS OF CASH FLOWS (continued)
Cumulative
From
March 12,
1991
Year ended December 31, (inception) to
--------------------------------------- December 31,
2002 2001 2000 2002
----------- ----------- ----------- ---------------
Cash flows from financing activities
Proceeds from issuance of notes payable $ 515,500
Proceeds from issuance of common stock $ 9,748,358 53,550,522
Proceeds from exercise of warrants $ 7,694 7,694
Share issuance expenses and other financing costs (906,571) (618,500) (4,511,676)
Purchase of treasury stock (34,855) (177,645)
Proceeds from issuance of loans payable 1,446,229
Proceeds from other obligations 4,000,000 6,000,000 10,000,000
Proceeds from issuance of convertible debentures 5,908,000 5,908,000
Proceeds from issuance of redeemable preferred
stock - series A 1,200,000 1,200,000
Proceeds from issuance of preferred
stock - series B 1,070,000 1,070,000
Repayment of capital lease obligations (91,728) (5,151) (198,932)
Repayment of loan payable (143,505) (132,370) (122,096) (706,178)
Repayment of other obligations (11,149) (11,149)
Repayment of notes payable (515,500)
----------- ----------- ----------- -----------
Net cash provided by financing activities 11,032,741 5,867,630 8,967,756 67,576,865
----------- ----------- ----------- -----------
NET INCREASE (DECREASE) IN CASH AND CASH
EQUIVALENTS (27,798) (8,438,453) (3,311,549) 826,227
Cash and cash equivalents at beginning of period 854,025 9,292,478 12,604,027 --
----------- ----------- ----------- -----------
Cash and cash equivalents at end of period $ 826,227 $ 854,025 $ 9,292,478 $ 826,227
=========== =========== =========== ===========
F-12
Ortec International, Inc.
(a development stage enterprise)
STATEMENTS OF CASH FLOWS (continued)
Cumulative
From
March 12,
1991
Year ended December 31, (inception) to
---------------------------- December 31,
2002 2001 2000 2002
-------- ------- ------- --------------
Supplemental disclosures of cash flow information:
Noncash financing activities
Capital lease obligations $449,441 $ -- $ -- $568,344
Deferred offering costs included in
accrued professional fees -- -- -- 314,697
Financing costs - other long-term obligations
included in accrued expenses -- 59,500 -- 59,500
Forgiveness of rent payable -- -- -- 40,740
Share issuance expenses - warrants -- -- 23,000 255,000
Dividends on series B preferred stock paid in
common shares 1,125,934 -- -- 1,125,934
Share issuance expenses for series B preferred
stock incurred through issuance of warrants 304,615 -- -- 304,615
Cash paid for interest 57,317 80,205 90,565 544,858
Cash paid for income taxes -- 44,528 41,286 199,576
The accompanying notes are an integral part of these statements.
F-13
ORTEC INTERNATIONAL, INC.
(a development stage enterprise)
NOTES TO FINANCIAL STATEMENTS
December 31, 2002, 2001 and 2000,
and for the period from March 12, 1991 (Inception) through December 31, 2002
NOTE 1 - FORMATION OF THE COMPANY AND BASIS OF PRESENTATION
Formation of the Company
Ortec International, Inc. ("Ortec" or the "Company") was incorporated in March
1991 as a Delaware corporation to secure and provide funds for the further
development of the technology developed by Dr. Mark Eisenberg of Sydney,
Australia, to replicate in the laboratory, a tissue engineered skin substitute
for use in skin regeneration procedures (the "Technology"). Pursuant to a
license agreement dated September 7, 1991, Dr. Eisenberg had granted Ortec a
license for a term of ten years, with automatic renewals by Ortec for two
additional ten-year periods, to commercially use and exploit the Technology for
the development of products. In April 1998, Dr. Eisenberg assigned his patent
for the Technology to Ortec.
The Skin Group, Ltd. (the "Skin Group") also was formed as a Delaware
corporation in March 1991, to raise funds for the development of the Technology.
On July 27, 1992, the Skin Group was merged with and into Ortec. Owners of Skin
Group shares were given .83672 of an Ortec share for each Skin Group share. The
merger was accounted for as if it were a pooling of interests and, accordingly,
the accompanying financial statements include the accounts of the Skin Group for
all periods presented.
Basis of Presentation
Ortec is a development stage enterprise, which had no operating revenue prior to
December 2001. During 2001, the Company received Food and Drug Administration
("FDA") approval for the use of OrCel for treatment of patients with recessive
dystrophic epidermolysis bullosa and donor sites in burn patients. The Company
then began marketing and selling its product for use on patients with these
indications. Revenues to date have not been significant, as the Company has been
focusing its effort and resources towards its clinical trial for the use of
OrCel for the treatment of venous stasis ulcers.
The accompanying financial statements have been prepared assuming that the
Company will continue as a going concern. The Company incurred a net loss of
$21,578,021 during the year ended December 31, 2002, and, as of that date, the
Company's current liabilities exceeded its
F-14
current assets by $17,787,545, its total liabilities exceeded its total assets
by $15,801,132 and the Company has a deficit accumulated in its development
stage of $81,858,609. These factors, among others, raise substantial doubt about
the Company's ability to continue as a going concern.
On March 27, 2002, the Company engaged H.C. Wainwright & Co., Inc. an investment
banking firm, to act as its financial advisor in connection with raising capital
for the Company through debt and/or equity financing. During 2002, Wainwright
assisted the Company in raising financing of approximately $8.2 million. During
2003, the Company has raised an additional $2.0 million in Preferred Series B
financing, as of February 26, 2003.
The Company requires substantial funding to continue its research and
development activities, clinical trials, manufacturing, sales, distribution and
administrative activities. The Company believes that its cash and cash
equivalents on hand at December 31, 2002, (approximately $0.8 million) and the
financing of $2.0 million received in February 2003, will enable it to continue
its operations until May 31, 2003. The Company is continuing its equity
financing efforts with H.C. Wainwright and expects to raise an additional $5.0
million from investors, some of whom have previously participated in the $10.2
million raised through February 26, 2003. This will enable the Company to
complete its venous clinical pivotal trial, file its PMA with the FDA and
execute its plan to engage the services of a third party manufacturer.
Accomplishing these milestones will also enable the Company to raise an
additional $5.0 million in 2003 through other potential collaborative
arrangements with companies for sales, marketing and distribution of its
product and through other equity investments. Based on these efforts, management
believes that the Company will be able to continue its operations for at least
the next 12 months.
Additionally, the Company continues to explore and, as appropriate, enter into
discussions with other companies regarding the potential for equity investment,
collaborative arrangements, license agreements or other funding programs with
the Company, in exchange for manufacturing, marketing, distribution or other
rights to its products. However, the Company can give no assurances that
discussions with other companies will result in any additional investments,
collaborative arrangements, agreements or other funding, or that the necessary
additional financing through debt or equity will be available to the Company on
acceptable terms, if at all. If additional funding is not available when needed,
the Company may not be able to continue operations.
These financial statements have been prepared assuming that the Company will
continue as a going concern. Successful future operations depend upon the
successful development and marketing of the Company's OrCel product.
Historically the Company has funded its operating losses by periodically raising
additional sources of capital. If additional funding is not available to the
Company when needed, the Company may not be able to continue operations. No
adjustments have been made to the accompanying financials as a result of this
uncertainty.
Initial Public Offering
On January 19, 1996, the Company completed an initial public offering ("IPO") of
1,200,000 units. Each unit consisted of one share of the Company's common stock,
one class A warrant to purchase one share of common stock at $10, of which
1,083,780 were exercised and the balance, which was not exercised, expired on
December 31, 1998, and one class B warrant to purchase one share of common stock
at $15, of which 11,400 were exercised and the balance which was not exercised,
expired on December 31, 2000.
F-15
The IPO raised gross proceeds of approximately $6,000,000, of which $800,000,
$537,500 and approximately $315,000 were used to pay underwriting commissions,
notes payable and deferred offering costs, respectively, thereby providing the
Company with net proceeds of approximately $4,347,500.
NOTE 2 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Revenue Recognition
Product revenue is recognized upon shipment of OrCel to our customers.
Research and Development Costs
The Company is in the business of research and development and therefore, all
research and development costs, including payments relating to products under
development, research, consulting agreements and personnel costs, are expensed
when incurred, and for 2001 and 2002, include the costs of production related to
sales, as such costs are not readily separable.
Depreciation and Amortization
Property and equipment are carried at cost, less any grants received for
construction. In 1996, the Company received a $400,000 grant toward the
construction of its new laboratory and office facilities and it received an
additional grant of $130,000 in 1998.
Office furniture and equipment and laboratory equipment are depreciated on the
straight-line basis over the estimated lives of the assets (5 years). Leasehold
improvements are amortized over the shorter of the term of the related lease or
the life of the asset. Depreciation and amortization expense for the years ended
December 31, 2002, 2001 and 2000, was approximately $649,000, $672,000 and
$657,000, respectively.
Intangible Assets and Impairment of Long - Lived Assets
The Company's intangible assets consist of patent application costs. Patent
application costs relate to the Company's U.S. patent applications and
application fees in foreign jurisdictions and consist of legal and other direct
fees. The recoverability of the patent application costs is dependent upon,
among other matters, obtaining further FDA approvals for the use of the
underlying technology.
The Company reviews long-lived assets, which consist of fixed assets and patent
application costs, for possible impairment whenever events or changes in
circumstances indicate that the carrying amount of an asset may not be
recoverable. The Company has determined that no provisions are necessary for the
impairment of long-lived assets at December 31, 2002 and 2001.
F-16
Effective January 1, 2002, the Company adopted Statement of Financial Accounting
Standards ("SFAS") No. 142 Goodwill and Other Intangible Assets. Under SFAS No.
142, goodwill and indefinite lived intangible assets are no longer amortized but
will be reviewed at least annually for impairment. Separable intangible assets
that are not deemed to have an indefinite life will continue to be amortized
over their useful lives.
As of January 1, 2002, the Company does not have any goodwill or intangible
assets with indefinite useful lives. The Company continues to amortize its
patent application costs over their estimated useful lives. Additionally, the
Company adopted SFAS No. 144 "Accounting for the Impairment or Disposal of
Long-Lived Assets" on January 1, 2002. Adoption of SFAS No.142 and SFAS No.144
did not have a material effect on financial position or results of operation.
Foreign Currency Translation
The Company had conducted some of its research and development at its laboratory
in Sydney, Australia. However, because all Australian expenditures were funded
from the United States, the Company has determined that the functional currency
of its Australian office is the U.S. dollar. Accordingly, current assets and
current liabilities are remeasured into the functional currency using current
exchange rates and non-current assets and liabilities are remeasured using
historical exchange rates. Expense accounts are measured using the average rate
in effect for the year. Gains and losses arising from the remeasurement of
foreign currency are included in the results of operations for all periods
presented.
As of December 31, 2002, the Company terminated all of its research and
development activities at its laboratory in Sydney.
Use of Estimates
In preparing financial statements in conformity with accounting principles
generally accepted in the United States of America, management is required to
make estimates and assumptions that effect the reported amounts of assets and
liabilities and disclosure of contingent assets and liabilities at the date of
the financial statements, as well as the reported amounts of revenues and
expenses during the reporting period. Actual results could differ from those
estimates.
Income Taxes
Deferred tax assets and liabilities are recognized for the estimated future tax
consequences attributable to differences between the financial statement
carrying amounts of existing assets and liabilities and their respective tax
bases and for the tax effects of net operating loss carryforwards. Deferred tax
assets and liabilities are measured using enacted tax rates in effect for the
years in which those temporary differences are expected to be recovered or
settled. 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.
The Company records a valuation allowance against its deferred tax assets
when there is doubt about the realizability of such assets.
F-17
Cash and Cash Equivalents
For purposes of the statement of cash flows, the Company considers all highly
liquid debt instruments purchased with original maturities of three months or
less to be cash equivalents. Cash equivalents consist principally of money
market funds. Cash and cash equivalents includes approximately $15,000 and
$2,000 at December 31, 2002 and 2001, respectively, of bank balances denominated
in Australian dollars.
Net Loss Per Share
Net loss per common share is based on the weighted-average number of common
shares outstanding during the periods.
Basic net loss per share is computed by dividing the net loss by the
weighted-average common shares outstanding for the period. Diluted net loss per
share reflects the weighted-average common shares outstanding plus the potential
dilutive effect of securities or contracts which are convertible to common
shares, such as options, warrants and convertible preferred stock.
Options and warrants to purchase shares of common stock were not included in the
computation of diluted net loss per share in each of the years presented because
to do so would have been antidilutive for the periods presented. (See Notes 8
and 9.)
The amount of options and warrants excluded are as follows:
Years ended December 31, 2002 2001 2000
---------- --------- ---------
Warrants 11,172,109 395,412 609,773
---------- --------- ---------
Stock Options - in plan 2,872,117 2,033,306 1,524,106
---------- --------- ---------
Stock Options - outside of plan 3,800,000
----------
Additionally, the effects of conversion of the preferred stock were excluded
from the computation of diluted net loss per share as the effect would be
antidilutive. An aggregate of 9,382,742 shares of common stock would be issuable
upon conversion of the preferred stock outstanding at December 31, 2002.
Basic loss per share for the year ended December 31, 2002 includes the 800,000
warrants exercisable at $.001 per share granted to Wainwright as outstanding
from the date of grant.
Employee Stock Option Plan
The Company accounts for its employee stock options under the recognition and
measurement principles of APB Opinion No. 25, Accounting for Stock Issued to
Employees, and related Interpretations. No stock-based employee compensation
cost is reflected in net income for the years ended December 31, 2002, 2001 and
2000, as all options granted under these plans had an exercise price equal to
the market value of the underlying common stock on the date of grant. The
following table illustrates the effect on net income and earnings per share if
the Company had applied the fair value recognition provisions of FASB Statement
No.123, "Accounting for Stock-Based Compensation".
F-18
Year ended December 31,
------------------------------------------
2002 2001 2000
------------ ------------ ------------
Net loss, as reported ($22,703,955) ($15,885,377) ($12,129,663)
Deduct: Total stock-based employee
compensation expense determined under
fair value based method (1,965,592) (2,893,720) (1,818,469)
------------ ------------ ------------
Pro forma net loss ($24,669,547) ($18,779,097) ($13,948,132)
------------ ------------ ------------
Loss per share:
Basic and Diluted - as reported ($2.01) ($1.64) ($1.37)
Basic and Diluted - pro forma ($2.18) ($1.94) ($1.58)
NOTE 3 - CONCENTRATION OF CREDIT RISK
The Company maintains cash and money market accounts at four financial
institutions located in New York City and one in Australia. Cash accounts are
insured by the FDIC for amounts up to $100,000. Uninsured balances aggregate to
approximately $628,000 and $725,000 at December 31, 2002 and 2001, respectively.
The Company has not experienced any losses in such accounts and believes it is
not exposed to any significant credit risk.
NOTE 4 - PATENTS
Patent application costs are stated at cost less amortization computed by the
straight-line method over the useful life of the patent, approximately 8 years
remaining at December 31, 2002. The Company's U.S. patent was issued in 1994 and
expires in 2011.
There can be no assurance that any patent will provide commercial benefits to
the Company. The Company has determined that no provision for impairment is
necessary at December 31, 2002.
The Company has granted a security interest in its United States and Canadian
patents and trademarks relating to OrCel to collateralize payments it will be
required to make to satisfy its other obligation (see Note 7).
NOTE 5 - CAPITAL LEASE OBLIGATIONS
Prior to 2002, the Company had entered into several capital lease agreements
with terms of two to three years at effective interest rates ranging from 12.22%
to 15.48%. The agreements ended during the year ended December 31, 2000.
F-19
In January 2002, the Company secured a $1,300,000 lease line of credit to be
used for the acquisition of additional manufacturing, laboratory and other
equipment required to expand its manufacturing capacity. During 2002, the
Company has drawn $449,000 against this line of credit for the acquisition of
eligible fixed assets.
As of December 31, 2002 and 2001, the Company has recorded $541,000 and $119,000
in equipment purchased under capital leases and $209,000 and $119,000 in
accumulated amortization, respectively. See Note 11 for commitments under
capital leases.
NOTE 6 - LOAN PAYABLE
During 1996, the Company obtained a loan from the landlord of its laboratory for
the construction of, and equipment for, the leased facility. During 1997, the
Company modified the terms of the loan as a result of increased build-out costs
incurred in the construction of the facility. An adjustment was made in 1997 to
record additional interest and principal. The adjusted loan payments are due in
monthly installments of $10,103, including interest at an effective rate of
7.98%, through July 2006.
During 1998, the Company obtained an additional loan from the landlord for
improvements to the leased facility. During 1999, the Company modified the terms
of the additional loan as a result of increased build-out costs incurred. The
adjusted loan payments are due in monthly installments of $7,605, including
interest at an effective rate of 8.6%, through March 2008. Minimum payments to
be made under the terms of these loans are as follows:
Year ending December 31,
2003 212,503
2004 212,503
2005 212,503
2006 161,988
2007 and thereafter 121,688
--------
921,185
Less amount representing interest 152,202
--------
Net present value of future loan payments $768,983
========
Current portion $155,578
Non-current portion 613,405
--------
$768,983
========
NOTE 7 - OTHER OBLIGATIONS
On August 29, 2001, the Company entered into a Revenue Interests Assignment
agreement with Paul Capital Royalty Acquisition Fund L.P. ("Paul Capital"),
which terminates on August 29, 2011. Under such agreement the Company was
eligible to receive $10,000,000 during 2001. The Company received $6,000,000
during 2001 and the remaining $4,000,000 in January 2002. In February 2003, Paul
Capital and the Company signed an amendment to the agreement, restating and
updating certain provisions of the original agreement, including removing
additional funding requirements by Paul Capital. On February 26, 2003, Paul
Capital invested an additional $500,000 in Series B preferred stock, in
concurrence with this amendment.
F-20
In consideration for the $10,000,000, Paul Capital will receive a minimum of
3.33% of end user sales of the Company's products in the United States, Canada
and Mexico. Such percentage may be further adjusted upward or downward, based on
the volume of net sales to end users of the Company's products in those three
countries. Beginning on January 1, 2003, Paul Capital will be entitled to
receive each year advances from the first proceeds to the Company from end user
sales of its products in North America. The agreement provides for quarterly and
annual accountings between Paul Capital and the Company for those advance
payments. Such annual amounts that Paul Capital will be able to draw in advance
will range from $600,000 in 2003 to $7,500,000 in 2005 and thereafter. The
amounts received from Paul Capital have been classified as debt. Pursuant to the
default provisions under the agreement, interest has been accrued at 30% per
annum. At such time when the default provisions are no longer applicable,
interest will be accrued based upon the expected level of future revenues, which
may result in a lower imputed interest rate, with potential material financial
impact.
In the event of a change in control of the Company or upon the occurrence of
certain other events, including insolvency, as defined in the agreement, Paul
Capital has the option to put its revenue interest back to the Company for an
amount of cash flows which will generate a 30% internal rate of return to Paul
Capital. The Company also has the option to repurchase Paul Capital's interest
upon the occurrence of a change in control of the Company or a complete
divestiture by the Company of its interests in its products, for an amount of
cash flows which will generate a 35% internal rate of return to Paul Capital.
At December 31, 2002, the Company's liabilities exceeded the value of its assets
and as such, the Company was technically in default of the solvency requirement
under the Paul Capital agreement. Paul Capital is aware of this breech and in
discussions with management regarding this issue, has indicated to the Company
that it does not intend to exercise its option to require the Company to
repurchase its revenue interest.
The Company granted Paul Capital a security interest in its United States and
Canadian patents and trademarks relating to its technology for its OrCel
product, to secure payments required to be made by the Company to Paul Capital
under this agreement.
NOTE 8 - EQUITY TRANSACTIONS
Each share of the Company's common stock is entitled to one vote.
In January 1993, Ortec effected a stock split and granted twenty new shares of
common stock of $.001 par value for each outstanding share of common stock. This
stock split is retroactively reflected in the accompanying financial statements
and all references to shares are to the new shares with per share amounts
appropriately adjusted.
F-21
Pursuant to an agreement between Dr. Eisenberg and the other founders (the
"Other Founders"), a business relationship was formed by the founders for the
manufacture and sale of products derived from the Technology (the "Business
Agreement"). Under the terms of the Business Agreement, Dr. Eisenberg, who was
the owner of all the capital stock of Ortec (600,000 shares) agreed to license
the Technology to Ortec and sell 70% of Ortec's shares for a purchase price of
$1,000,000 to the Skin Group. Dr. Eisenberg was paid $85,000 in connection with
this agreement as reimbursement for his expenses ($35,000 during the period from
inception (March 12, 1991) to December 31, 1991 and $50,000 during the year
ended December 31, 1992).
The "Other Founders" initially owned all of the stock of the Skin Group (953,820
shares). In March 1991, the Skin Group issued, in a private placement, 217,440
shares for $65,000. In June and October 1991, the Skin Group issued 130,160 and
18,860 shares, to a then director of the Company (the "Director") for $150,000
and $100,000, respectively. Commencing in November 1991, the Skin Group issued
79,480 shares under a second private placement for $750,006 (including 26,460
shares during the year ended December 31, 1992). On July 27, 1992, the Skin
Group was merged with and into Ortec.
Also under the second private placement 22,860 shares of Ortec were issued for
$215,467. In addition, the Director was granted warrants to purchase 7,360
shares of Ortec at $9.425 per share.
Pursuant to a stock purchase agreement entered into with the Director in June
1992, 53,040 shares of Ortec were sold to the Director for a total purchase
price of $499,998. In addition, the Director was granted warrants to purchase
79,570 shares at an exercise price of $9.425 per share, such warrants were
exercised on December 29, 1998. The purchase price was payable in installments
and shares and warrants were issued in installments pro rata with the payment of
the purchase price. During the years ended December 31, 1993 and 1992, the
Director paid $200,000 and $299,998, respectively, and was issued 21,220 and
31,820 shares, respectively.
Further, in connection with the Director's purchase of the 53,040 shares, in
1993, the Other Founders granted to the Director options to purchase from them
an aggregate of 74,000 Ortec shares, at a price of $5 per share. In 1993, the
Director exercised such option in part, and purchased 49,000 shares from the
Other Founders at the option price of $5 per share. The remaining balance of
such options expired April 15, 1994.
Pursuant to a third private placement that commenced in January 13, 1993, and
concluded on March 31, 1993, Ortec sold an aggregate of 109,650 shares at $10
per share ($1,096,500). Subsequent to such offering, in 1993, the Company sold
an additional 22,500 shares at $10 per share ($225,000). In connection with such
purchases, all purchasers received certain registration rights.
Pursuant to a Stock Purchase Agreement dated July 19, 1993, by and between Ortec
and the Home Insurance Company ("Home Insurance"), the Company sold to Home
Insurance 111,111 shares of common stock for an aggregate purchase price of
$999,999, or $9 per share. In connection with such purchase, Home Insurance
received certain registration rights.
F-22
In addition, in 1993, the Company issued 600 shares to an individual as
compensation for commissions in connection with the sale of the Company's
shares. Such commissions are included in share issuance expenses. The stock
issued was valued at $10 per share.
In August 1993, the Director entered into a stock option agreement with Dr.
Eisenberg and the Other Founders, pursuant to which he received the right to
purchase an aggregate of 100,000 shares owned by such persons in various amounts
and at various times, at a purchase price of $10 per share. As of December 31,
1993, the Director had exercised options and purchased 5,000 shares under such
agreement at $10 per share. The remaining balance of such options has expired.
Pursuant to a fourth private placement consummated in July 1994, Ortec sold an
aggregate of 39,451 shares at between $10 and $10.25 per share for aggregate
proceeds of $397,712.
Pursuant to a Stock Purchase Agreement dated July 22, 1994, between Ortec and
Home Insurance, the Company sold to Home Insurance 50,000 shares of common stock
for an aggregate purchase price of $500,000, or $10 per share. In connection
with such purchase, Home Insurance received certain registration rights and
warrants to purchase 10,000 shares of common stock at $12 per share, which
expired on July 21, 1997.
On January 19, 1996, the Company completed an initial public offering ("IPO") of
1,200,000 units for aggregate proceeds of $6,000,000. Each unit consisted of one
share of the Company's common stock, one Class A warrant to purchase one share
of common stock at $10 and one Class B warrant to purchase one share of common
stock at $15. As of December 31, 1998, 1,083,780 Class A warrants were exercised
and the balance expired unexercised. The Class B warrants were originally set to
expire in January 1999. The Company extended the expiration date to March 31,
2000. The Class B warrants are subject to redemption by the Company at $.01 per
warrant. The Company received gross proceeds of approximately $1,282,000 and
$10,823,000 and net proceeds of approximately $1,262,000 and $10,165,000 as a
result of the exercise of warrants in 1998 and 1997, respectively.
In November 1996, the Company completed a private placement of its securities
from which it received gross proceeds of $6,220,797 and net proceeds of
approximately $5,733,000 (after deducting approximately $487,000 in placement
fees and other expenses of such private placement). The Company sold 959,106
shares of common stock in such private placement at average prices of $6.49 per
share. In addition, the Company granted five-year warrants to placement agents
to purchase such number of shares equal to 10% of the number of shares of common
stock sold by such placement agents, exercisable at prices equal to 120% of the
prices paid for such shares. Pursuant to the purchasers' request, the Company
registered all 959,106 shares.
During 1992 and 1993, the Company issued warrants to purchase 6,660 shares at
$9.425 per share, and during 1995 the Company issued warrants to purchase 2,000
shares at $10 per share to members of the Scientific Advisory Board of the
Company. During 1996 and 1997, the Company issued warrants to purchase 242,101
shares at $6 to $12 per share to the Director and certain others. These warrants
expired at various dates through November 2001.
F-23
On January 20, 1996, the Company granted "lock-up warrants" entitling
shareholders to purchase an aggregate of 389,045 shares of the Company's common
stock at a price of $1.00 per share. All unexercised warrants expired on January
18, 2000. At different times during 1996, seven persons exercised such warrants
and purchased 33,885 shares of common stock at the $1.00 per share exercise
price. The issuance of such lock-up warrants was in consideration for such
shareholders signing lock-up agreements agreeing not to sell or transfer shares
of the Company's common stock purchased at prices of $9.00 or more per share
until January 20, 1997. At different times during the third quarter of 1997,
eight persons exercised such warrants and purchased an aggregate of 21,210
shares of common stock at the $1.00 per share exercise price. During 1998, nine
persons exercised such warrants and purchased an aggregate of 96,077 shares of
common stock at the $1.00 per share exercise price. During 1999, five persons
exercised such warrants and purchased an aggregate of 14,103 shares of common
stock at the $1.00 per share exercise price. There were no underwriting
discounts or commissions given or paid in connection with any of the foregoing
warrant exercises.
During the third quarter of 1997, the Company granted to one person and its
seven designees four-year warrants to purchase an aggregate of 37,500 shares of
common stock, at an exercise price of $12.00 per share. Such warrants are not
exercisable until July 18, 1998 and were granted in consideration for consulting
services rendered to the Company.
During the fourth quarter of 1997, the Company granted to one person and its six
designees four-year warrants to purchase an aggregate of 37,500 shares of common
stock, at an exercise price of $12.00 per share. Such warrants are not
exercisable until July 18, 1998 and were granted in consideration for consulting
services rendered to the Company.
During 1998, warrants for 18,700 shares, mentioned in the two previous
paragraphs, were exercised utilizing the cashless exercise option of the warrant
agreement. The Company issued 6,204 shares under this exercise.
During the third quarter of 1997, the Company granted to one person a one-year
warrant to purchase an aggregate of 625 shares of common stock, at an exercise
price of $12.00 per share. Such warrants were granted in consideration for
consulting services rendered to the Company. The warrant was exercised during
1998.
The Company recorded consulting expense of approximately $64,000 as a result of
these grants during the year ended December 31, 1998.
During the fourth quarter of 1997, the Company granted five-year warrants to its
three executive officers to purchase an aggregate of 240,000 shares of common
stock, at an exercise price of $12.00 per share. Such warrants were granted in
consideration for services rendered to the Company. The exercise of such
warrants is contingent upon the occurrence of certain events, which were
considered probable at December 31, 1997. As of December 31, 1998, five of the
six events have occurred so that 185,000 of those warrants are now vested. As a
result, the Company recorded compensation expense of approximately $80,000 in
December 1997 and $1,185,000 for the year ended December 31, 1998.
F-24
The balance of the warrants became vested upon the exercise of warrants owned by
a director in December 1998 in accordance with the terms of certain compensation
provisions as approved by the Company's Board of Directors.
In consideration for services rendered by him as a director of the Company in
the five-year period from 1992 to 1996 for which he never received compensation,
the Company extended by one year to December 31, 1998 the expiration date of
warrants owned by a director to purchase an aggregate of 86,930 shares,
exercisable at $9.425 per share. As a result, the Company recorded compensation
expense of approximately $420,000, during the fourth quarter of 1997. All of
these warrants were exercised on December 29, 1998.
During the fourth quarter of 1998, the Company granted five-year options to its
three executive officers to purchase an aggregate of 520,750 shares of common
stock, at exercise prices ranging from $12.13 to $12.44 per share. The exercise
of such options was contingent upon the occurrence of certain events. All of
these options became vested upon the exercise of warrants owned by a director in
December 1998 in accordance with the terms of certain compensation provisions as
approved by the Company's Board of Directors. As a result, the Company recorded
compensation expense of approximately $495,000 in December 1998.
In December 1998, the Company completed a private placement of its securities
from which it received proceeds of $2,000,000. In addition, the Company granted
three-year warrants to the Purchaser to purchase 50,000 shares at $12 per share.
The Company sold 200,000 shares of common stock in such private placement. The
Company assigned value to the common stock and warrants issued of $1,788,698 and
$211,302 based upon the relative fair market value of the stock at the date of
issuance and the estimated fair value of the warrants using the Black-Scholes
option pricing model.
In March 1999, the Company completed a private placement of 389,156 shares of
its common stock to twenty investors from which it received proceeds of
approximately $3,405,000. In addition, each investor also received a three-year
warrant to purchase 20% of the number of shares of the Company's common stock
such investor purchased in such private placement. The prices at which such
warrants are exerciseable are $12.50 per share for one half, and $14.50 per
share for the other half, of the number of shares issuable upon exercise of such
warrants. The Company assigned value to the common stock and warrants issued to
the investors of $3,168,785 and $236,291 based upon the relative fair market
value of the stock at the date of issuance and the estimated fair market value
of the warrants using the Black-Scholes option pricing model. Oscar Gruss & Son,
Incorporated ("Gruss") acted as placement agent in such private placement. For
its services as placement agent, the Company paid Gruss $272,406 and granted
Gruss a five-year warrant to purchase an aggregate of 38,915 shares of the
Company's common stock at an exercise price of $10.50 per share. The value
assigned to the Gruss warrants was $232,000. Other share issuance costs amounted
to $106,002.
In December 1999, the Company completed a private placement of 1,636,364 shares
of its common stock to two institutional funds from which it received proceeds
of approximately $9,000,000. Share issuance costs amounted to approximately
$9,500.
F-25
In March 2000, the Company completed a private placement of 66,667 shares of its
common stock to one fund from which it received proceeds of approximately
$1,000,000. In addition, the Company paid a placement agent who introduced the
Company to the fund a fee of approximately $43,400 and granted such placement
agent a five year warrant to purchase 2,667 shares of the Company's common stock
at an exercise price of $15.00 per share. The value assigned to the warrant was
$23,000, which was reflected as share issuance costs. Other share issuance costs
amounted to $3,200.
In September 2000, the Company completed a private placement of 1,247,566 shares
of its common stock to ten investors from which it received approximately
$8,421,000. In addition, the Company paid the placement agent who introduced the
Company to the investors a fee of approximately $525,400. Other share issuance
costs amounted to approximately $46,500.
In April 2001, the Company issued options to purchase 60,000 shares of the
Company's common stock, at $6.95 per share, to certain professionals. The
estimated fair value of $188,080 of such options has been recorded as an expense
in the accompanying financial statements.
In September 2001, the Company, with shareholder approval, increased the
authorized amount of its common stock to 35,000,000 shares and authorized the
issuance of up to 1,000,000 shares of preferred stock.
During 2002, the Company completed a private placement with several investors,
in which the Company raised cash proceeds of $8.2 million through the issuance
of debentures and preferred stock, which were ultimately converted into Series B
redeemable convertible preferred shares, which were issued with warrants to
purchase common shares and common stock dividends paid in advance. (See Note 9)
In February 2003, the Company, with shareholder approval, increased the
authorized amount of its common stock to 200,000,000 shares.
The following table summarizes warrant activity during the period from March 12,
1991 (inception) through December 31, 2002 (excluding the Class A and B warrants
which were issued during the IPO):
Price range Shares
--------------- ----------
March 12, 1991 (inception) to December 31, 1991
Granted $9.425 7,360
----------
Balance, December 31, 1991 9.425 7,360
Granted 9.425 55,080
----------
Balance, December 31, 1992 9.425 62,440
Granted 9.425 - 12.00 48,230
----------
Balance, December 31, 1993 9.425 - 12.00 110,670
Granted 12.00 10,000
----------
Balance, December 31, 1994 9.425 - 12.00 120,670
Granted 10.00 4,000
Expired 9.425 (2,680)
----------
Balance, December 31, 1995 9.425 - 12.00 121,990
Granted 1.00 - 10.00 511,606
Exercised 1.00 (33,885)
Expired 12.00 (2,450)
----------
F-26
Balance, December 31, 1996 1.00 - 12.00 597,261
Granted 12.00 - 14.25 330,625
Expired 12.00 (10,000)
----------
Balance, December 31, 1997 1.00 - 14.25 917,886
Granted 12.00 - 14.00 75,000
Exercised 1.00 - 12.00 (205,852)
Expired 12.00 (108,425)
----------
Balance, December 31, 1998 1.00 - 14.25 678,609
Granted 12.50 - 14.50 116,745
Exercised 1.00 (14,103)
Expired 6.00 - 9.425 (17,160)
----------
Balance, December 31, 1999 1.00 - 14.25 764,091
Granted 15.00 2,667
Exercised 12.00 (2,000)
Expired 1.00 -10.00 (154,985)
----------
Balance, December 31, 2000 7.70 - 15.00 609,773
Expired 7.70 - 12.00 (214,361)
----------
Balance, December 31, 2001 $ 7.70 - 15.00 395,412
Granted $.001 - $6.2475 22,210,148
Exercised $.001 (9,739,969)
Expired $.001 - $14.50 (1,693,482)
----------
Balance, December 31, 2002 $.001 - $15.00 11,172,109
==========
The following table summarizes warrant data as of December 31, 2002:
Weighted
Average Weighted Weighted
Remaining Average average
Range of Number contractual Exercise Number exercise
exercise prices outstanding life price exercisable price
--------------- ----------- ----------- -------- ----------- --------
$.001 440,000 .08 years $ .001 440,000 $ .001
$1.50 to $2.00 10,621,277 6.87 years $ 1.72 -- --
$4.50 to $6.25 44,250 1.01 years $ 4.83 44,250 $ 4.83
$7.70 to $10.50 38,915 1.23 years $10.50 38,915 $10.50
$14.00 to $15.00 27,667 1.01 years $14.10 27,667 $14.10
F-27
NOTE 9- AMENDMENT OF THE COMPANY'S CERTIFICATE OF INCORPORATION AND ISSUANCES OF
12% CONVERTIBLE DEBENTURES, SERIES A PREFERRED STOCK AND SERIES B PREFERRED
STOCK
Amendment of Certificate of Incorporation-
On June 25, 2002, the Company's board of directors unanimously adopted an
amendment to the Company's certificate of incorporation designating 2,000 shares
out of the 1,000,000 shares of preferred stock that the Company is authorized to
issue, as Series A Convertible Preferred Stock, and designating the relative
rights and preferences of the Series A Convertible Preferred Stock. The stated
value, which is also the Liquidation Preference of the Series A Convertible
Preferred Stock, is $10,000 per share. The Company is required to pay dividends
on the Series A Preferred shares, at the rate of 6% per annum of the $10,000
Liquidation Preference per share, through June 30, 2003; at the rate of 9% per
annum thereafter until June 30, 2004; and thereafter at the rate of 12% per
annum. At the Company's option such dividends may be paid in the Company's
common stock at the "conversion price" for the conversion of such dividends if
such shares of common stock have been registered under the Securities Act of
1933 for sale in the public securities markets. The conversion price is fixed
initially at $1.50 per share of the Company's common stock.
On November 7, 2002, the Company's board of directors adopted an amendment to
the Company's certificate of incorporation designating 2,000 shares out of the
1,000,000 shares of preferred stock, as Series B Convertible Preferred Stock at
a stated value of $10,000 per share. Dividends on the Series B Preferred shares
is payable at the rate of 12% per annum, in cash or shares of common stock, at
the option of the Company, except that in the first year, dividends are payable,
in advance, in shares of common stock.
The Series B preferred stock is convertible into common shares at any time at
the option of the investor, based on a fixed conversion rate of $1.00, or
commencing after February 1, 2003, based on an alternative conversion rate equal
to 90% of the average of the five lowest volume weighted average prices for the
common stock for the twenty trading days immediately prior to conversion,
subject to a floor price of $0.25. The fixed conversion rate may be adjusted
downward if the Company subsequently issues common stock at a purchase price
less than $0.50. In that event, the fixed conversion rate will be adjusted
downward to the price of the new issuance. Conversion is mandatory upon the
occurrence of certain financial events, such as, beginning six months from the
date of issue, if the closing bid price of common shares exceeds $2.00 for a
period of 20 consecutive trading days, or if within nine months from the date of
issue, the Company completes a public offering, raising a minimum of $8 million.
The alternative conversion price is adjustable or cancelable under certain
circumstances, such as, in the event that the Company receives a licensing fee
and/or a strategic investment of at least $5.0 million within six months of
closing, the alternative conversion rate is adjusted to the common share price
of the investment or is cancelled if the share price exceeds the fixed rate
F-28
of $1.00. If within six months from date of issue, the Company receives a
licensing fee with an upfront payment of at least $5.0 million, the alternative
conversion rate is adjusted to the quoted closing stock price on the day of the
public announcement or is cancelled if this closing price exceeds $1.00.
Similarly, if the Company completes a subsequent public or private financing of
a least $5.0 million within six months of closing, the alternative conversion
rate is adjusted to the closing price or the fixed rate of $l.00, if lower.
The preferred stock has redemption provisions, where upon occurrence of certain
events, the holders can require the Company to redeem the shares. The redemption
price is payable, at the option of the Company, in cash or in common stock. If
the Company does not have sufficient authorized shares to effect the redemption
payment in common stock, the Company may pay the remainder of the redemption in
non-redeemable preferred stock with a dividend rate of 18%.
Issuance of 12% Convertible Debentures, Series A Preferred Stock and Series B
Preferred Stock:
On March 27, 2002, the Company engaged H.C. Wainwright, an investment-banking
firm, to act as its advisor and to assist with raising capital for the Company
in the form of either debt or equity financing.
On May 13, 2002, the Company sold $2,333,000 of 12% convertible debentures,
which were convertible into common shares at the lesser of $3.36 or the price
per share of the equity securities to be issued in a subsequent financing. These
debentures, bear interest at the rate of 12% per annum, up to October 10, 2002
and 18% thereafter and are due on April 10, 2003. The Company also issued
291,625 stock purchase warrants as part of this May 13, 2002 financing,
exercisable at $4.50 per share for up to 5 years from the date of grant. The
warrants had price protection features whereby the price of the warrants can be
reduced to the prices at which common stock or common stock equivalents are
thereafter sold by Ortec.
On June 28, 2002, $600,000 of these debentures sold on May 13, 2002 were
converted into Series A Preferred Stock at 110% of face value plus accrued
interest. Additionally, on June 28, 2002, the Company issued an additional
$250,000 of 12% convertible debentures and $1,200,000 in Series A convertible
preferred stock. The total face value of the preferred stock issued
was $1,870,120 which consisted of the $1,200,000 of cash proceeds received, the
$600,000 face value of converted debentures and the $70,120 of additional
conversion face value and accrued interest. Additionally, the Series A preferred
stock was convertible into common shares at a rate of $1.50 per share. The
Series A preferred stock had provisions whereby redemption was out of the
control of the Company, therefore, the preferred stock was classified in a
manner similar to debt.
On June 28, 2002, the Company also issued 654,624 stock purchase warrants, at an
exercise price of $1.875 per common share for a five-year period. Of the
654,624, an aggregate of 31,250 warrants were issued with the debentures, with
the remainder issued with the preferred stock. The warrants also had similar
price protection features, whereby the price of the warrants can be reduced to
the prices at which common stock or common stock equivalents are thereafter sold
by the Company.
F-29
The relative estimated fair value of the warrants issued in connection with the
debentures of $422,000 was recorded as debt discount, as well as the estimated
fair value of the beneficial conversion features of $1,042,663. Both of these
values were being amortized over the remaining life of the convertible
debentures, or through April 10, 2003.
The relative estimated fair value of the warrants issued in connection with the
Series A Preferred stock of $559,289 was recorded as a discount to the preferred
stock and was accreted to interest expense, on the date of issuance.
Additionally, the estimated fair value of the beneficial conversion feature of
$1,097,886 has been recorded as an additional discount and accreted to interest
expense. The Series A preferred stock has no redemption date, and therefore
the charge to interest expense was reflected immediately as the conversion
privilege was excercisable immediately.
During the 3rd quarter of 2002, the Company issued $1,425,000 in convertible
debentures, with terms comparable to those issued in the 2nd quarter.
Additionally, 178,127 warrants were issued with similar terms to warrants issued
on May 13, 2002. Additional debt discount of $18,523 related to the warrants
was recorded in the third quarter, which was being amortized over the
remaining useful life of the convertible debentures.
In October and November 2002, the Company issued an additional $1,900,000 in
convertible debentures and 237,501 warrants, with terms comparable to those
issued on May 13, 2002. Upon conversion of all outstanding debentures into
Series B preferred stock as discussed below, the remaining unamortized debt
discounts relating to warrants and beneficial conversion features were charged
to interest expense.
These debentures along with the accrued interest were convertible into equity
securities if the Company completed the sale of at least $5,000,000 in equity
securities by July 12, 2002, which date was extended through November 13, 2002.
On November 13, 2002, all outstanding debentures and accrued interest were
converted into preferred stock with the closing of the Series B Preferred Stock
financing. These were converted at the rate of 110% of the debentures plus
accrued interest into $10,000 par value Series B Convertible preferred shares.
In November and December 2002, the Company issued 938.2742 shares of Series B
convertible preferred stock to several investors in a private placement, which
was funded by an aggregate of $8,178,000 of financing received, which included
$1,070,000 of new Series B preferred stock and the conversion of the
aforementioned convertible debentures and convertible Series A preferred stock.
The Company recorded a loss on extinguishment of debentures and preferred shares
of $1,004,027, principally due to the additional buying power granted to the
investors. The convertible debentures and convertible Series A preferred were
converted at 110% of face value, plus accrued interest. In addition, these
investors were granted Series A warrants, to purchase 9,382,742 shares of
the Company's common stock at an exercise price of $.001. These Series A
warrants vested immediately and were exercised immediately, upon grant.
The investors were also granted Series B-1 and Series B-2 warrants, which
can be used to purchase 5,429,891 and 4,691,386 shares of common stock at an
exercise price of $1.50 and $2.00 per share, respectively. These B-1 are
exercisable beginning August 13, 2003 and expire seven years from the date of
grant and the B-2 warrants are exercisable beginning November 13, 2003 and
expire 7 years from date of grant. The Company assigned values to the preferred
stock and the Series A, Series B-1 and Series B-2 warrants issued to the
investors of $5,903,699, $2,245,206, $694,447 and $539,390, based upon the
relative fair market
F-30
value of the stock at the date of issuance and the estimated fair market value
of the warrants, using the Black-Scholes option pricing model.
The warrants issued with the second quarter and third quarter financings were
exchanged for B-1 warrants, issued in the fourth quarter and are included in the
number of warrants issued in the prior paragraph.
Dividends on the Series B preferred stock were paid in advance in November and
December in common shares at the rate of 12% upon issue of the preferred shares
and will be paid semiannually in subsequent years, in either cash or common
shares, at the election of the Company, until at such time as the preferred
stock is converted to common shares. In conjunction with this preferred stock
financing the investors were paid a common stock dividend, whereby the investors
were granted 3,753,116 shares of common stock, of which 2,934,888 shares were
issued in November 2002 and 818,228 shares in January 2003.
In addition, certain of the investors were given options to purchase, for one
year and for amounts ranging from 100% to 200% of their investments, shares of
the Series B Convertible Preferred stock at the price paid for such stock by
investors on November 13, 2002.
H.C. Wainwright & Company, Inc. ("Wainwright") acted as placement agent in this
private placement. For its services as placement agent, the Company paid
Wainwright $601,490 and granted Wainwright and its agents warrants to purchase
800,000 and 500,000 shares of common stock, at an exercise price of $.001 and
$1.50, vesting immediately upon issue and November 13, 2003, respectively. These
warrants will expire on January 31, 2003 and seven years from issue,
respectively. In December 2002, the Company issued 357,227 shares of common
stock relative to the $.001 warrants granted to Wainwright. The fair market
value assigned to the Wainwright warrants was $280,000 and $24,615 for the $.001
warrants and the $1.50 warrants, respectively. Other share issuance costs,
including non-cash costs, amounted to $155,997. Issuance costs for the Series B
Preferred Stock are reflected as a reduction of the proceeds of the preferred
stock. An additional 440,000 of warrants with an exercise price of $.001 were
exercised in January 2003. An aggregate of 797,227 shares were issued pursuant
to these warrants, which were substantially exercised using cashless exercise
provisions in such warrants.
Under EITF 00-19, "Accounting for Derivative Instruments Indexed to and
Potentially Settled in the Company's Own Stock", as of December 31, 2002, the
Series B Preferred stock is reflected as equity.
NOTE 10 - STOCK OPTIONS AND WARRANTS
In April 1996, the Board of Directors and stockholders approved the adoption of
a stock option plan (the "Plan"). The Plan provides for the grant of options to
purchase up to 350,000 shares of the Company's common stock. These options may
be granted to employees, officers of the Company, non-employee directors of the
Company and consultants to the Company. The Plan provides for granting of
options to purchase the Company's common stock at not less than the fair value
of such shares on the date of the grant. The options generally vest ratably over
a four-year period and expire after seven years.
In August 1998, the stockholders and Board of Directors ratified and approved an
amended and restated 1996 Stock Option Plan increasing the maximum number of
shares of the Company's common stock for which stock options may be granted from
350,000 to 1,550,000 shares. In August 2000, the stockholders and Board of
Directors ratified and approved the second amendment to the Company's Amended
and Restated 1996 Stock Option Plan increasing the number of shares of the
Company's common stock for which options have been or could be granted under the
Plan from 1,550,000 to 3,000,000 shares.
F-31
In February 2003, the stockholders and Board of Directors ratified and approved
an amended and restated Stock Option Plan, increasing the maximum number of
shares of the Company's common stock for which stock options may be granted from
3,000,000 to 4,500,000 shares. As of December 31, 2002, 120,133 options were
available for grant under the plan.
The following table summarizes the stock option activity through December 31,
2002:
Weighted average
Number exercise price
--------- ----------------
Granted - adoption of stock option plan 156,000 $ 7.08
---------
Balance, December 31, 1996 156,000 7.08
Granted 123,000 11.94
Forfeited, expired (3,000) 6.63
---------
Balance, December 31, 1997 276,000 9.25
Granted 689,750 12.10
Exercised (6,750) 7.42
Forfeited, expired (14,500) 11.19
---------
Balance, December 31, 1998 944,500 11.17
Granted 399,000 10.87
Forfeited, expired (221,000) 14.93
---------
Balance, December 31, 1999 (carried forward) 1,122,500 10.33
Balance, December 31, 1999 (brought forward) 1,122,500 $10.33
Granted 449,956 7.96
Exercised (3,500) 7.00
Forfeited, expired (44,850) 8.27
---------
Balance, December 31, 2000 1,524,106 $12.30
Granted 756,500 5.93
Forfeited, expired (247,300) 7.41
---------
Balance, December 31, 2001 2,033,306 $ 8.54
Granted 1,155,109 1.29
Forfeited, expired (316,298) 7.68
---------
Balance, December 31, 2002 2,872,117 $ 5.73
=========
F-32
The following data has been provided for exercisable options:
December 31,
------------------------------------
2002 2001 2000
---------- ---------- ----------
Number of options 2,235,544 1,686,707 1,237,706
Weighted average exercise price $6.57 $8.93 $12.02
Weighted remaining contractual
life 4.26 years 4.71 years 3.95 years
The exercise price for all stock options awarded within the plan are determined
in accordance with the provisions of the Stock Option plan, as approved by the
shareholders and Board of Directors of the Company.
The weighted average fair value at the date of grant for options granted during
the years ended December 31, 2002, 2001 and 2000 was $1.29, $3.83 and $4.37,
respectively.
The following table summarizes option data as of December 31, 2002:
Weighted
Average Weighted Weighted
Remaining average average
Range of Number Contractual exercise Number exercise
exercise prices outstanding life Price exercisable Price
- --------------- ----------- ----------- -------- ----------- --------
$.30 to $.60 763,353 6.36 years $ 0.36 548,500 $ 0.38
$1.00 to $3.53 216,258 1.92 years $ 1.51 35,000 $ 3.53
$4.50 to $7.50 1,006,000 4.90 years $ 5.72 778,425 $ 5.64
$8.00 to $10.44 332,006 4.69 years 9.49 319,119 9.47
$10.50 to $14.25 540,500 0.89 years 12.30 540,500 12.30
$14.25 to $21.38 14,000 0.37 years 21.06 14,000 21.06
--------- ---------
2,872,117 4.26 years $ 5.73 2,235,544 $ 6.57
========= ---------- ====== ========= ------
The Company recognized approximately $1,696,000 of compensation expense for
options and warrants issued to officers and directors of the Company in 1998.
Such options and warrants were accounted for as variable option grants. Such
options and warrants had vested prematurely in December 1998, upon the exercise
of warrants owned by a director of the Company, in accordance with the terms of
certain compensation provisions provided for and approved by the Company's Board
of Directors.
The Company utilized the Black-Scholes option-pricing model to quantify the
expense of options and warrants granted to non-employees and the pro forma
effects on net loss and net loss per share of the fair value of the options and
warrants granted to employees during the years ended December 31, 2002, 2001 and
2000. The following weighted average assumptions were made in estimating fair
value.
F-33
Year ended December 31,
---------------------------
2002 2001 2000
------- ------- -------
Risk-free interest rate 3.5 % 4.6 % 4.5 %
Expected option life 7 years 7 years 7 years
Expected volatility 120.2 % 65.8 % 65 %
During the year ended December 31, 2002, the Company issued 3,800,000 options to
senior executives, which were not included in the Plan. The exercise price of
these options was $0.35, the market price on the date of grant. These options
are vested immediately and expire seven years from date of issue.
In addition, the Company recognized approximately $113,000, $188,000 and $56,000
in consulting expenses in 2002, 2001 and 2000, respectively, for options and
warrants granted to independent consultants and investment bankers for services
rendered to the Company.
NOTE 11 - COMMITMENTS AND CONTINGENCIES
Agreement With Dr. Eisenberg
Pursuant to an amended agreement, the Company has engaged the services of Dr.
Eisenberg as a consultant through August 31, 2005. The consulting agreement may
be renewed for an additional two years unless terminated by either party prior
to such renewal period. Under the agreement, Dr. Eisenberg is obligated to
devote twenty hours per week to Company business and is entitled to an annual
compensation for such services with annual increases, as defined. In addition,
Dr. Eisenberg is paid $58 per hour for services in excess of twenty hours per
week. The agreement also provides for a bonus in the event the Company files for
the registration of any patent. The bonus, which shall be determined by the
Board of Directors of the Company, shall not be less than $30,000 per patent
registration, but may not aggregate more than $60,000 during any twelve-month
period. As of December 31, 2002 and for the cumulative period since inception,
no bonuses have been earned by Dr. Eisenberg. For each of the years ended
December 31, 2002, 2001 and 2000, Dr. Eisenberg earned approximately $73,000 for
consulting services and approximately $834,000 for the period from inception to
December 31, 2002, which is included in research and development expense.
Included in accrued compensation at December 31, 2002 and 2001 are $109,822 and
$36,826, respectively, representing unpaid consulting fees to Dr. Eisenberg.
F-34
Sales Force
In December 2001, the Company entered into an agreement with PDI, Inc. ("PDI"),
a pharmaceutical and medical device and diagnostics sales and marketing company
to provide a dedicated sales force to the Company to target the donor site burn
market. The agreement provides for a monthly fee based on the number of sales
representatives engaged plus commissions based upon sales of OrCel.
During the quarter ended September 30, 2002, PDI commenced legal action against
the Company, claiming that the Company owes them $205,000 for services that they
have performed for the Company. The Company is in the process of discussing a
settlement of the amount claimed with PDI. The Company has provided for
estimated amounts due to PDI.
Supply Agreements
In October 1991, the Company entered into an agreement with Cornell University
Medical College ("Cornell"), a medical institution in New York City, for Cornell
to produce and supply the Company, on an exclusive basis and using Dr.
Eisenberg's technology, all of the cultured skin equivalent necessary for the
Company's use in human clinical tests in the United States. Fees earned by
Cornell amounted to approximately $1,145,000 for the period from inception to
December 31, 1996. The Cornell arrangement was terminated as of December 31,
1996.
Research Agreement
In January 1997, the Company entered into an agreement with the New Jersey
Center for Biomaterials and Medical Devices (the "New Jersey Center"), whereby
the Company and the New Jersey Center will collaborate on research focusing on
the development of collagen-based biomaterials for soft tissue repair,
specifically targeting the development of a second generation collagen matrix to
be used for the production of OrCel. The Company contributed $40,000 of the
$100,000 cost of such research in 1998, $45,000 in 1999 and the final $15,000 in
2000. This agreement was terminated as of December 31, 2000.
Occupancy Arrangements
The Company leases approximately 5,000 square feet of space in Sydney,
Australia, on a month-to-month basis, in which the Company operates a research
laboratory to conduct its research and development activities in Australia and
to produce OrCel used in the operations conducted in Australia. The Company pays
rent in Australian dollars, which at the current rate of exchange, amounts to
approximately US $25,000 per year. This space is rented from Dr. Mark
Eisenberg's father on terms that the Company believes are not less favorable to
it than for rental of similar space in Sydney, Australia, from non-related third
parties. The Company terminated this agreement effective December 31, 2002.
F-35
During the year ended December 31, 1995, Dr. Eisenberg's father waived the
rights to $40,740 of unpaid rent which was accounted for as additional paid-in
capital.
In March 1996, the Company entered into a five-year lease with Columbia
University for the Company's laboratory and offices in Columbia's new Audubon
Biomedical Science and Technology Park in New York City. Construction of the
laboratory and office facility was completed in July 1996 and became fully
operational in November 1996. In 1996, the Company also granted Columbia a
warrant, which expired in March 2001, to purchase 5,000 shares of common stock
at an exercise price of $10 per share. In addition, Columbia had agreed to
provide the Company with a grant of $400,000 and a ten-year self-amortizing loan
with interest at the rate charged by Columbia's bank for up to an additional
$600,000, to build and equip the Company's laboratory. During 1998, the Company
received the $600,000 loan and an additional grant of $130,000 and entered into
two leases with Columbia for additional space in the building. During 2000, the
Company extended the two leases for another year and entered into a new lease
for additional space in the building. During 2001, the Company extended two of
its leases, one for an additional two years and the other for one year and
entered into a new lease for additional space in the building. During 2002, the
Company terminated three of its leases, reducing the amount of space under lease
and extended the term on its primary lease to June 2004. The Company utilizes
its laboratory facilities to produce OrCel.
On December 31, 2002, the Company amended the lease agreement with Columbia
University, extending the lease term to June 2004, as mentioned above. With this
amendment, the Company also obtained a waiver of its default for non - payment
of past due rent and loan amounts, with an agreed payment plan of these past due
amounts in 2003.
Total rent expense for the years ended December 31, 2002, 2001 and 2000 was
approximately $683,000, $589,000 and $535,000, respectively.
In December 2001, the Company entered into a ten-year lease with the New Jersey
Economic Development Authority ("NJEDA") to lease approximately 58,000 square
feet of manufacturing and office space, located in North Brunswick, New Jersey.
These premises would become available to the Company in two phases. The initial
space, consisting of approximately 26,000 square feet, is in an existing
building, which was to be renovated to the Company's specifications. The second
phase, approximately 32,000 square feet, would be newly constructed and
adjoining the initial space.
On August 5, 2002, the Company reached an agreement with the New Jersey Economic
Development Administration to terminate the December 2001 lease and to enter
into a new lease covering only the initial space of approximately 26,000 square
feet of production and office space. Due to the lower level of financing in 2002
than had originally been planned, the Company is currently engaged in
discussions with the NJEDA to defer or terminate the lease entered into in
August 2002. We can give no assurance that we will be able to defer or terminate
this obligation or what damages, if any, incurred by NJEDA because of our
failure to perform our obligations under this lease, we may have to pay.
F-36
The minimum rental payments on non-cancelable leases with terms
exceeding one year at December 31, 2002 are as follows:
Year ending December 31, Operating Leases Capital Leases
- ------------------------ ---------------- --------------
2003 820,000 175,156
2004 543,000 175,156
2005 416,000 58,717
2006 --
2007 --
Thereafter --
========= =======
Total 1,779,000 409,029
=========
Less: Amounts representing interest 51,316
=======
Principal Payments 357,713
=======
Current portion 142,620
Long-term portion 215,093
=======
357,713
=======
Government Regulation
The Company is subject to extensive government regulation. Products for human
treatment are subject to rigorous pre-clinical and clinical testing procedures
as a condition for approval by the FDA and by similar authorities in foreign
countries prior to commercial sale. Presently, the Company is continuing its
clinical trials for the use of its product in the treatment of patients with
venous leg ulcers and to submit the results of its human clinical trials to the
FDA; however, it is not possible for the Company to determine whether the
results achieved from the human clinical trials will be sufficient to obtain FDA
approval.
NOTE 12 - LEGAL PROCEEDINGS
The Company has been notified by Columbia University, the landlord of premises
at 3960 Broadway in New York City, where we maintain our principal offices,
laboratory and production facilities, that we have been delinquent in payment of
rent. The Company has reduced the amount of the space leased from Columbia
University, as part of our program to reduce spending. The Company has
negotiated a pay out of the remainder of our unpaid obligations to Columbia. The
Company's ability to make such payment is dependent on our ability to continue
to secure additional equity financing.
ClinTrials Networks, LLC (ClinTrials) has claimed that the Company has breached
its agreement with them, which provided for ClinTrials to arrange and manage the
FDA mandated clinical trials for use of our OrCel product for the treatment of
venous stasis ulcers, and for other services. In October 2002, ClinTrials
commenced an arbitration proceeding against the Company, claiming that the
Company owes ClinTrials $165,936 and that ClinTrials reserves the right to claim
additional amounts from the Company, based on continuing additional monthly fees
ClinTrials claims that it is entitled to receive under their agreement with us.
The Company has denied ClinTrials' claim and has advised ClinTrials that it is
not in breach of its contract. In March 2003 the Company filed a counterclaim
for overpayment of $75,000 under the terms of the contract, and as such, the
Company has not provided for any additional amounts due under this contract.
F-37
During the quarter ended September 30, 2002, PDI, Inc. commenced an action
against the Company in the Superior Court of New Jersey, Bergen County, claiming
that the Company owes $205,000 to PDI for services that they have performed for
us. The Company is in the process of discussing a settlement of the amount
claimed with PDI. The Company has provided for estimated amounts owed to PDI.
In December 2002 Amarex LLC commenced an action against the Company in the
Circuit Court for Montgomery County, Maryland. Amarex provided statistical
programming and data management services for the Company for the data generated
in the Company's clinical trials. Although in its complaint Amarex claims the
Company owes it $2,457,875, that amount is the additional amount the Company
would have had to pay Amarex if Amarex had performed all the work needed for
all of the Company's contemplated clinical trials. The Company has answered
Amarex's complaint denying Amarex's claim. The Company is negotiating with
Amarex to establish the amount of services Amarex performed for the Company
for which it has not already been paid and to arrange for payment of that
amount. The Company has provided for estimated amounts due to Amarex.
On August 5, 2002, the Company reached an agreement with the New Jersey Economic
Development Administration to terminate the current lease of approximately
58,000 square feet and to enter into a new lease for approximately 26,000 square
feet of production and office space in North Brunswick, New Jersey. The Company
is currently in discussion with the NJEDA to defer or terminate this lease for
26,000 square feet. The Company is unable to estimate what amount may be payable
to NJEDA to defer or terminate this agreement and accordingly, no amounts have
been provided for in the accompanying financial statements.
By letter dated June 27, 2002, the staff of the Nasdaq Stock Market, Inc.,
advised the Company that it had not met Nasdaq's requirements for continued
listing of its common stock on the Nasdaq SmallCap market. On July 1, 2002, the
Company appealed that determination and requested an oral hearing before the
Nasdaq Listing Qualification Panel. At that hearing, which was held on August 8,
2002, the Company asked the panel to defer delisting the Company's common stock
for up to six months, in order to give the Company time to complete its plan to
raise sufficient capital to provide for the Company's cash needs for the next
twelve months and enable the Company to meet Nasdaq's requirements for continued
listing of its common stock on the Nasdaq SmallCap market. Nasdaq denied the
Company's request and the Company's stock was moved to the Nasdaq Buletin Board
and as such, still meets the listing requirements of the Company's preferred
stock holders.
NOTE 13 - RELATED PARTY TRANSACTIONS
Prior to December 31, 1998, the "Other Founders" were paid fees for services
rendered of approximately $980,000 in the aggregate, for the period from
inception to December 31, 1998. In addition, in 1996, $140,000 was paid to a
director as cash compensation for services as placement agent in connection with
the November 1996 private placement. Also, the director received 30,500 warrants
(see Note 8).
In December 1997, the Company extended the expiration date on warrants to the
director to purchase 86,930 shares, exercisable at $9.425 per share, resulting
in compensation expense of approximately $420,000 (see Note 8).
F-38
The Company paid approximately $35,000 and $25,000 for the years ended December
31, 1997 and 1996, respectively, as fees for accounting services, to a
stockholder (approximately $100,000 for the period from inception to December
31, 1997). Also during the year ended December 31, 1996, the Company repaid
loans of approximately $247,000 from the net proceeds of the "IPO" to officers.
Prior to June 1996, the Company's executive offices were located in office space
leased by a company owned by an officer, founder and director of the Company on
a rent-free basis.
Change of Control and Termination of Employment Agreements
In December 1998, the Company's Board of Directors authorized agreements between
the Company and its four executive officers, which state that in the event of a
"change of control" certain "special compensation arrangements" will occur. On
December 5, 2002, these agreements, relating to three of the executive officers,
were modified by the Company's Board of Directors. As modified, each of the
three executive officers will receive certain benefits and compensation in the
event of the individual's death, disability, retirement or if terminated without
cause, as defined in the agreement.
NOTE 14 - INCOME TAXES
The Company has deferred start-up costs for income tax purposes and intends to
elect to amortize such costs over a period of 60 months, under Section 195(b) of
the Internal Revenue Code, when the Company commences operations.
At December 31, 2002, the Company had net operating loss carry-forwards of
approximately $17,877,000 for Federal and New York State income tax purposes
expiring through 2022. Due to the merger of Skin Group with and into Ortec in
July 1992, the net operating losses and other built-in deductions existing at
that time were subject to annual limitations pursuant to Internal Revenue Code
Section 382. The Company's ability to utilize net operating losses and other
built-in deductions generated after that date may be limited in the future due
to additional issuances of the Company's common stock or other changes in
control, as defined in the Internal Revenue Code and related regulations.
For financial statement purposes, a valuation allowance of approximately
$30,873,000 and $23,294,000 at December 31, 2002 and 2001, respectively, has
been recognized to offset entirely the Company's deferred tax assets, which
arose primarily from the Company's operating loss carry-forwards and the
deferral of start-up expenses for tax purposes and accrued interest, as the
realization of such deferred tax assets is uncertain.
Components of the Company's deferred tax asset are as follows:
December 31,
---------------------------
2002 2001
------------ ------------
Net operating loss carry-forwards $ 7,508,000 $ 6,179,000
Deferral of start-up costs 21,029,000 16,757,000
Interest 1,825,000 --
Other 511,000 358,000
------------ ------------
30,873,000 23,294,000
Valuation allowance (30,873,000) (23,294,000)
------------ ------------
Net deferred tax asset $ -- $ --
============ ============
F-39
The following reconciles the income taxes computed at the Federal Statutory rate
to the amounts recorded in the Company's statement of operations:
Year ended December 31, Cumulative from
--------------------------------------- March 12, 1991 (inception)
2002 2001 2000 to December 31, 2002
----------- ----------- ----------- --------------------------
Income tax benefit at the
Statutory rate $(7,337,000) $(5,401,000) $(4,124,000) $(27,450,000)
State and local income
taxes, net of Federal
benefit (1,443,000) (1,270,000) (961,000) (4,624,000)
Permanent differences 1,201,000 -- -- 1,201,000
Effect of valuation
allowance 7,579,000 6,671,000 5,085,000 30,873,000
----------- ----------- ----------- ------------
Total $ -- $ -- $ -- $ --
=========== =========== =========== ============
The Company's net operating loss tax carry-forwards expire as follows:
December 31, 2006 $ 76,000
December 31, 2007 233,000
December 31, 2008 511,000
December 31, 2009 597,000
December 31, 2010 440,000
December 31, 2011 677,000
December 31, 2012 839,000
December 31, 2018 1,189,000
December 31, 2019 2,602,000
December 31, 2020 3,535,000
December 31, 2021 4,014,000
December 31, 2022 3,164,000
-----------
$17,877,000
===========
The Company's ability to utilize its net operating losses may be limited by
changes in control, as defined in the Internal Revenue Code.
NOTE 15 - OPERATIONS IN OTHER GEOGRAPHIC AREAS
Long-lived assets, which consists of fixed assets and patents, are located as
follows as of December 31, 2002 and 2001
2002 2001
---------- ----------
United States $2,064,481 $2,139,341
Australia -- 63,056
---------- ----------
$2,064,481 $2,202,397
========== ==========
F-40
NOTE 16 - FAIR VALUE OF FINANCIAL INSTRUMENTS
Statement of Financial Accounting Standards No. 107 ("SFAS No. 107"), "Fair
Value of Financial Instruments," requires disclosure of the estimated fair value
of an entity's financial instrument assets and liabilities. For the Company,
financial instruments consist principally of cash and cash equivalents, loans
payable and other long-term obligations.
The following methods and assumptions were used to estimate the fair value of
each class of financial instrument for which it is practicable to estimate that
value.
Cash and Cash Equivalents
The carrying value reasonably approximates fair value because of the short
maturity of those instruments.
Loans Payable and Other Long-term Obligations
Based on borrowing rates currently available to the Company for bank loans and
other financings with similar terms and maturities, the carrying value of the
Company's loans payable, capital lease obligations and other long-term
obligations approximate the fair value.
NOTE 17 - IMPACT OF RECENTLY ISSUED ACCOUNTING STANDARDS
On April 31, 2002, the FASB issued Statement of Financial Accounting Standard
No.145, "Rescission of FASB Statements No.4, 44 and 64, Amendment of SFAS No.13,
and Technical Corrections" ("SFAS no.145"). SFAS No.145 rescinds Statements
No.4, which required all gains and losses from extinguishments of debt to be
aggregated and, if material, classified as an extraordinary item, net of the
related income tax effect. Upon adoption of SFAS No.145, companies will be
required to apply the criteria in APB Opinion No.30, "Reporting the Results of
Operations-Reporting the Effects of Disposal of a Segment of a Business, and
Extraordinary, Unusual and Infrequently Occurring Events and Transactions" in
determining the classification of gains and losses resulting from the
extinguishments of debt. SFAS No.145 is effective for fiscal years beginning
after May 15, 2002. The Company is currently evaluating the requirements and
impact of this statement on its results of operations and financial position.
On July 30, 2002, the FASB issued Statement of Financial Accounting Standard
No.146, "Accounting for Costs Associated with Exit or Disposal Activities" (SFAS
N0.146"). The standard requires companies to recognize costs associated with
exit or disposal activities when they are incurred rather than at the date of a
commitment to an exit or disposal plan. Examples of costs covered by the
standard include lease termination costs covered by the standard include lease
termination costs and certain employee severance costs that are associated with
a restructuring, discontinued operation, plant closing, or other exit or
disposal activity. SFAS No.146 is to be applied prospectively to exit or
disposal activities initiated after December 31, 2002. This statement will be
applied prospectively to disposal activities initiated after December 31, 2002.
F-41
Stock-Based Employee Compensation
In December 2002, the FASB issued Statement 148 (SFAS 148), Accounting for
Stock-Based Compensation -- Transition and Disclosure: an amendment of FASB
Statement 123 (SFAS 123), to provide alternative transition methods for a
voluntary change to the fair value based method of accounting for stock-based
employee compensation. In addition, SFAS 148 amends the disclosure requirements
of SFAS 123 to require prominent disclosures in annual financial statements
about the method of accounting for stock-based employee compensation and the pro
forma effect on reported results of applying the fair value based method for
entities that use the intrinsic value method of accounting. The pro forma effect
disclosures are also required to be prominently disclosed in interim period
financial statements. This statement is effective for financial statements for
fiscal years ending after December 15, 2002 and is effective for financial
reports containing condensed financial statements for interim periods beginning
after December 15, 2002, with earlier application permitted. The Company does
not plan a change to the fair value based method of accounting for stock-based
employee compensation and has included the disclosure requirements of SFAS 148
in the accompanying financial statements.
NOTE 18 - QUARTERLY FINANCIAL DATA (UNAUDITED)
Summarized quarterly financial for the years ended December 31, 2002 and 2001,
is as follows:
Quarter Ended
March 30th, June 30, September 30, December 31,
------------------------ ------------------------ ------------------------ ------------------------
2002 2001 2002 2001 2002 2001 2002 2001
- ----------------------------------------------------------------------------------------------------------------------------
Revenues $ 116,415 $ -- $ 92,535 $ -- $ 34,825 $ -- $ -- $ 21,890
- ----------------------------------------------------------------------------------------------------------------------------
Net loss $(5,144,138) $(3,494,473) $(7,272,547) $(3,753,130) $(3,989,473) $(4,173,593) $(6,297,797) $(4,464,181)
- ----------------------------------------------------------------------------------------------------------------------------
Net loss per share
Basic and diluted $(.53) $(.36) $(.75) $(.39) $(.41) $(.43) $(.39) $(.46)
- ----------------------------------------------------------------------------------------------------------------------------
NOTE 19 - SUBSEQUENT EVENTS
Issuance of Series B Convertible Preferred Stock
In February 2003, the Company received additional gross proceeds of $2 million
from five investors, who had purchased the Company's Series B convertible
preferred stock in November and December 2002, and from one new investor. The
Company issued to the six investors 200 shares of the Company's convertible
preferred stock, 2,923,077 shares of the Company's common stock, of which
923,077 common shares constituted the first year dividends on the 200 shares of
Series B convertible preferred stock, which dividends were paid in advance. The
investors were also granted warrants to purchase an additional 2,000,000 shares
of common stock, of which warrants to purchase 1,000,000 shares are exercisable
at $1.50 per share and warrants to purchase the other 1,000,000 shares are
exercisable at $2.00 per shares. In March 2003, in addition to cash
compensation, the Company also granted to H.C. Wainwright, and to one of its
designees, for their services in arranging the aforementioned financing,
warrants to purchase an aggregate of 376,923 shares of the Company's common
stock, exercisable at $.001 per share.
F-42
STATEMENT OF DIFFERENCES
The trademark symbol shall be expressed as.................. 'TM'
The section symbol shall be expressed as.................... 'SS'