10KSB: Optional form for annual and transition reports of small business issuers [Section 13 or 15(d), not S-B Item 405]
Published on June 13, 2002
FORM 10-KSB
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
[X] ANNUAL REPORT PURSUANT TO SECTION 13 or 15(d) OF THE SECURITIES EXCHANGE
ACT OF 1934
For the fiscal year ended: February 28, 2002
Commission File Number: 0-12305
Repro-Med Systems, Inc.
-----------------------
(Exact name of registrant as specified in its charter)
New York 13-3044880
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(State or other jurisdiction of (IRS Employer
incorporation or organization) Identification No.)
24 Carpenter Road, Chester, NY 10918
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(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code: (845) 469-2042
Securities registered pursuant to Section 12(b) of the Act: None
Securities registered pursuant to Section 12(g) of the Act:
Name of each exchange on
Title of each class which registered
------------------- ----------------
Common stock, $.01 Par Value Over the Counter Bulletin Board
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
during the past 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 the disclosure of delinquent filers pursuant
to Item 405 of Regulation S-B, 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-KSB
or any amendment to this Form 10-KSB. [ X ]
Based on the closing sales price of February 28, 2002, the aggregate
market value of the voting and nonvoting common equity held by non-affiliates of
the registrant was $1,029,300.
The number of issued outstanding of the registrant's common stock, $.01
par value was 23,504,000 at February 28, 2002 which includes 2,275,000 shares of
Treasury Stock.
Repro-Med Systems, Inc.
Table of Contents
PART I Page
Item 1 Business ............................................... 3
Item 2 Description of Property ................................ 10
Item 3 Legal Proceedings ...................................... 10
Item 4 Submission of Matters to a Vote of Security Holders .... 10
PART II
Item 5. Market for the Registrant's Common Equity and Related
Shareholder Matters .................................... 10
Item 6. Management's Discussion and Analysis of Financial
Condition and Results of Operations .................... 11
Item 7. Financial Statements ................................... 17
Item 8. Changes in and Disagreements with Accountants on
Accounting and Financial Disclosures ................... 30
PART III
Item 9. Directors, Executive Officers, Promoters and Control
Persons: Compliance With Section 16(a) of the
Exchange Act ........................................... 31
Item 10. Executive Compensation ................................. 32
Item 11. Security Ownership of Certain Beneficial Owners
and Management ......................................... 33
Item 12. Certain Relationships and Related Transactions ......... 35
PART IV
Item 13. Exhibits and Reports on Form 8-K ....................... 35
2
PART I
Item 1. Business
THE COMPANY
Repro-Med Systems, Inc. went public in 1982 (OTC - symbol REPR). We design and
manufacture medical devices directing resources to the global markets for
emergency medical products and infusion therapy. We maintain a presence in the
US markets for impotency treatments and gynecological instruments. These
products are regulated by the FDA.
Repro-Med Systems, Inc. was incorporated under the laws of the State of New
York, March 1980. The corporate offices are located at 24 Carpenter Road,
Chester, New York 10918. The telephone number is 845-469-2042, fax is
845-469-5518 and the Internet site is www.repro-med.com
PRODUCTS
The primary growth strategy is to develop unique, proprietary medical devices.
These devices are intended to save money for the user and create a repetitive
demand for replacement of the disposable component - "razor - blade model". This
strategy led to our development of products for the ambulatory infusion systems
and emergency medical equipment markets. Historically, contract manufacturing
was a strong source of revenue, but the Company is transitioning away from this
market in order to concentrate on our own proprietary devices. Male infertility
and impotency treatments were the first markets entered in the early 1980's. Our
presence in this market has decreased due to a shift in focus towards the
RES-Q-VAC and FREEDOM60. The Company is seeking outside funding to introduce a
couples sexual enhancement or dysfunction kit into this market. Gyneco, the
gynecological instrument subsidiary, was acquired in 1986 and sales continue
primarily through repeat business.
The table below presents the product mix for the last two fiscal years.
2002 2001
% of Sales % of sales
---------- ----------
Infusion Therapy 12 % 7 %
Emergency Medical 63 % 55 %
Contract Manufacturing 16 % 27 %
Gynecological Instruments 9 % 10 %
Male Impotency Treatments Less than 1 % 1 %
We have also been developing other new proprietary medical devices, which would
be viewed as state-of-the-art and as fixed asset devices. These products include
a device for female incontinence and a device that can be used to detect certain
cancers non-invasively using special imaging techniques. Thus, we have products
currently on the market, new short-term products about to be marketed, and long
range products to support and enhance future growth. Research and Development
efforts for our new products have been temporarily suspended for some and
continue at a reduced rate for others. The Company will focus more efforts on
the Research and Development front once funds become available through increased
funds or outside financing.
3
AMBULATORY INFUSION SYSTEMS
The FREEDOM60 Syringe Infusion Pump was designed for ambulatory infusions.
Ambulatory infusion pumps are most prevalent in the home care market. The home
infusion therapy market is comprised of 4,500 sites of service, including local
and national organizations, hospital-affiliated organizations, and national home
infusion organizations with approximately $4.5 Billion in revenue annually (Ref:
www.nhianet.org). With insurance reimbursement in a severe decline, there is a
tremendous need for a low-cost, effective alternative to electronic and
expensive disposable IV administration devices for the home care and nursing
home market.
The FREEDOM60 provides a high-quality delivery to the patient at costs similar
to gravity and is targeted for the home health care industry, patient emergency
transportation, and for any time a low-cost infusion is required.
For the home care patient, FREEDOM60 is an easy-to-use lightweight mechanical
pump acting on a 60cc syringe, completely portable, cost effective and
maintenance free--no batteries to replace, no cumbersome IV pole. For the
infusion professional, FREEDOM60 delivers precise infusion rates and uniform
flow profiles providing consistent transfer of medication. A Form 510(k)
Premarket Notification for initial design of the FREEDOM60 as a Class II device
was approved by the FDA in May 1994.
During 2001, we developed a new version of the pump called the FREEDOM60-FM
containing an electronic flow monitor system (occlusion and end of infusion
alarm) which has opened excellent marketing avenues in nursing homes, hospitals
and pediatric ambulatory applications where alarms are generally required for
nursing acceptance. Nurses also appreciate being able to visualize the drug
volume by reading the scale on the syringe.
We signed a group purchasing agreement in December 1999 with Child Health
Corporation of America (CHCA) for the FREEDOM60 Syringe Infusion System. CHCA is
a cooperative and business alliance of 38 children's hospitals and home care
facilities which represents $4.5 billion in annual revenues, has over 61,000
hospital employees and 19,000 pediatricians and pediatric specialists. The
agreement calls for CHCA to assist us to market the FREEDOM60 to its members
through December 2002. Currently eight of the hospitals are actively using the
system, and we are pursuing adding other hospitals in the system prior to the
agreement expiration.
During August 2001, we began a trial of the FREEDOM60 at one location of a major
national home healthcare agency. We received our first order, as a result of the
successful trial, in September 2001. Since then we have added two more sites and
have 4 trials in progress. We will be working diligently to begin trials at the
remaining locations within the next six to twelve months.
As a direct result of our sales efforts at the Medica Trade Show in Dusseldorf,
Germany, the Company authorized an Italian distributor to obtain the CE Mark to
market the FREEDOM60 in Europe. We have been advised that the distributor has
obtained the CE Mark and at the end of February we shipped product to Italy for
distribution and trial.
Repro-Med Systems' objective is to build a product franchise with FREEDOM60 and
the sale of patented disposable tubing sets. FREEDOM60 uses rate-controlled
tubing with standard slide clamp and luer-lock connector. The patented syringe
disc connector insures that only FREEDOM60 tubing sets sold by us will function
within the pump. Non-conforming tubing sets, without the patented disc
connector, are ejected from the pump and prevent an overdose or runaway pump
from injuring the patient.
4
THE MARKET FOR PUMPS & DISPOSABLES
The ambulatory market has been rapidly changing due to reimbursement issues.
Insurance reimbursement has been drastically reduced providing opportunity for
FREEDOM60. The market share of high-end electronic type delivery systems is on
the decline as well as high-cost disposable non-electric devices. Market
pressures have forced patients to go on low-cost gravity systems or IV push
where the drug is pushed into the vein directly from a syringe. This is a
low-cost option but has been associated with complications and considered by
many to be a high-risk procedure. Thus, the overall trend has been towards
syringe pumps due to the low-cost of disposables. FREEDOM60-FM addresses the
largest market segments with the lowest cost alarm syringe pump system.
The chart below summarizes the market trends of devices.
Method of Market
Administration Trend
-------------- -----
Ambulatory Pump Flat/Declining
Gravity Infusion Increasing
Pole Mounted Pump Declining
Elastomeric Declining
Syringe Increasing
Implant Increasing
IV Push Increasing
ECONOMIC BENEFITS OF FREEDOM60 DISPOSABLE SALES
At the moment we estimate that there are approximately 1,600 Freedom60 pumps
currently in use. We sold approximately 720 pumps during the past fiscal year.
The Freedom60 pump is designed for a minimum use of 4,000 cycles which at our
list price is amortized at a low $.05 per use. The tubing sets currently have a
list price of $3.30. From past experience, we have noted that each pump is used
an average of 12 times per month. If the pump is operated up to 4 times per day,
the total use per month would be 48, and thus the pump life expectancy is
anticipated to be over six and a half years. This monthly rate amounts to annual
usage of 144 sets producing typical gross revenues to the distributor of $475
per pump. Installed bases for various levels of pumps produce the following
sales:
Pumps In Annual Sales
Market of Disposables
------ --------------
5000 $ 2,376,000
10000 $ 4,752,000
50000 $23,760,000
100000 $47,520,000
We have a combination of direct sales and sales through distributors.
Distributors typically receive discounts from list price depending upon
servicing and volumes of up to 35%.
COMPETITION FOR THE FREEDOM60
FREEDOM60 competes in the United States infusion pump market based on price,
service and product performance. Some of the competitors have significantly
greater resources for research and development, manufacturing and marketing, and
as a result may be better prepared to compete for market share even in areas in
which FREEDOM60 products may be superior.
5
The industry is subject to technological changes and there can be no assurance
that we will be able to maintain any existing technological lead long enough to
establish our products and to sustain profitability.
EMERGENCY MEDICAL PRODUCTS
Emergency medical products consists of two lines; RES-Q-VAC hand powered
emergency suction pump and PLUS Reusable Silicone Resuscitators.
RES-Q-VAC provides a complete emergency suction system for neonates, children
and adults for use in any location, as it is non-electric. RES-Q-VAC removes
fluids from a patient's airway. RES-Q-VAC consists of a hand-held, portable
suction pump that can be connected to various sized sterile or non-sterile
catheters. The one-hand operation makes it extremely effective particularly in
emergencies. The disposable features of the RES-Q-VAC reduce the risk of
contaminating the technician, for example, from HIV when suctioning a patient or
during post treatment cleanup. All the parts that connect to the pump are
disposable. RES-Q-VAC was introduced in 1990 and is now sold in thirty-one
countries. The product is generally found in emergency vehicles, hospitals and
as backup support for powered suction systems.
The RES-Q-VAC is currently the market leader for manual, portable suction
instruments. The primary competition is the V-Vac from Laerdal. The V-Vac is
more difficult to use, cannot suction infants, and cannot be used while wearing
heavy gloves such as in chemical warfare or extreme cold. Laerdal had more
resources than Repro-Med Systems and had begun marketing the V-Vac before
RES-Q-VAC entered the market. The RES-Q-VAC, however, has proven to be
significantly superior and dominates the market to date. Every market leader can
expect competition and recently Ambu has entered the market with the Res-Cue
brand pump, a product similar to RES-Q-VAC, made in China. Management believes
the product is not as well made or as versatile, and may not be purchased by the
military segment of the market due to lines of supply concerns. With additional
capital, management believes it will continue to maintain and build market share
with an improved RES-Q-VAC (discussed below) and gain a significant portion of
the electric suction pump market with the introduction of the RES-Q-VAC Plus
system currently under development.
On April 10, 2001, we submitted a patent application for our new FULL STOP
PROTECTOR. This upgrade to the RES-Q-VAC system prevents any fluids from exiting
the system. It also serves to trap airborne and fluid pathogens. We believe that
the addition of the full stop design substantially separates the RES-Q-VAC from
competitive units, which tend to leak fluid when becoming full or could pass air
born pathogens during use. There is a heightened concern from health care
professionals concerning exposure to disease and the new RES-Q-VAC provides
substantially improved protection for these users.
OSHA 29CFR 1910.1030 - Occupational Exposure to Bloodborne Pathogens requires
that employers of "...emergency medical technicians, paramedics, and other
emergency medical service providers; fire fighters, law enforcement personnel,
and correctional officers... must consider and implement devices that are
appropriate [to contain bloodborne pathogens], commercially available and
effective." These first responders risk exposure to serious disease, and the
employers may risk OSHA violations and lawsuits if they fail to consider
protective measures such as Repro-Med's FULL STOP PROTECTION for RES-Q-VAC. The
Company has received a letter from OSHA indicating the RES-Q-VAC meets the
intent of this regulation.
6
The PLUS line is not very profitable for Repro-Med so management has decided to
liquidate inventory on hand to discontinue this line.
RES-Q-VAC and PLUS are sold domestically and internationally by emergency
medical device distributors. These distributors generally advertise these
products in their catalogs.
IMPOTENCY TREATMENTS
We market the RESTORE Kit for the treatment of impotency. RESTORE uses vacuum
therapy to naturally induce blood flow to enable an erection. The kit includes
Pro-Long constriction rings that make it possible to trap the blood and maintain
the erection.
The US market for impotency treatments is estimated at 30 million men. Pfizer
reports that Viagra will not work for 30%-40% of impotent men. Consequently, the
potential market for the RESTORE Kit in the US is approximately 10 million men.
We have been compelled by limited resources to rely heavily on the web site to
generate interest and sales for the RESTORE Kit.
GYNECOLOGICAL INSTRUMENTS
We purchased the Gyneco product line in 1986. Products included the Masterson
Endometrial Biopsy Kit for in-office biopsy sampling procedures and the Thermal
Cautery System used for tubal ligation procedures.
Masterson Endometrial Biopsy Kit is a self-contained unit that offers a quick
and easy procedure for in-office tissue sampling. The powerful vacuum pump is
easily operated with one hand. The pump is supplied with sterile disposable
curettes and specimen containers presented in a kit.
The Thermal Cautery System is designed to provide a safe, reliable and effective
method of female sterilization. The unit is small, compact and portable. A
rechargeable battery supplies power. The unit uses disposable components that
include the cautery hook assembly, cannula and Trocar stylette.
CONTRACT MANUFACTURING
Historically, we have used OEM profits to partially fund internal product
development that has resulted in RES-Q-VAC and FREEDOM60. OEM sales have been as
high as 70% of sales (1996). In 2002 and 2001, contract manufacturing for one
customer amounted to 16% and for two customers 27% of sales, respectively. In
late 1998, one customer substantially reduced marketing support for its product
and consequently requested postponement of shipments. We have been manufacturing
a portable, hand-operated suction pump for sale to the remaining active customer
but have been informed that the demand for this product has diminished. As a
result, the Company is transitioning from these contracts to building and
selling its own proprietary products due to the much-improved margins associated
with directly marketed devices.
7
SALES AND DISTRIBUTION
Distribution channels for the products are those generally common to their
respective markets. Emergency medical products are sold through a wide network
of domestic and international distributors in 31 overseas countries. Ambulatory
infusion systems are sold through both direct sales efforts concentrated on
large national accounts and a network of medical device distributors.
Gynecological instruments are sold from the corporate offices primarily through
repeat business. Male impotency treatment products are marketed primarily
through the web site and a limited number of distributors of personal care
items.
We signed a group purchasing agreement that facilitates sales presentations to
approximately 38 allied members of the Child Health Corporation of America.
Currently 8 of the members are using our products. The agreement will expire in
December 2002 along with the substantially low prices that these centers are
receiving. We are actively pursuing the addition of more of these centers so
that they may institute the product at their center and enjoy the low prices for
several months before the agreement expires.
During the past year, we signed agreements with other distribution groups for
various marketing efforts of our different products, but these proved not to be
fruitful and the Company has decided to take a more active role in the sales and
marketing process. We are still open to outside distributors but we have no
assurance that they will be able to produce and at what sales levels they will
be able to produce.
MANUFACTURING AND EMPLOYEES
Electromechanical assembly, calibration, pre- and post-assembly quality control
inspection and testing, and final packaging for all products are performed at
the facility by the employees. Products are assembled using molded plastic parts
acquired from one supplier located in Taipei, Taiwan and several U.S. vendors.
The availability of parts has not been a problem. The cost and time required to
fabricate molds to manufacture parts can slow the development of new products
and might temporarily limit supply if we determine it is advisable to seek
alternate sources of supply for existing products. Our policy has been to have
multiple vendors as suppliers, where practicable, that also offer mold-building
capabilities as a service.
In February 2002, we employed 25 employees, 20 were assigned to manufacturing
operations, 3 to administrative functions, 1 Vice President of Operations
(responsible for manufacturing, warehouse and procurement operations), and 1
Executive Officer (Andrew Sealfon). The Company is dependent on the services of
Andrew Sealfon who serves as President and the head of Research and Development
and is also instrumental in marketing and finance. The Company does not have
insurance on the life of Andrew Sealfon and may not be able to replace him if
the need arose.
REGULATIONS GOVERNING THE MANUFACTURING OPERATIONS
The Food, Drug and Cosmetic Act governs the development and manufacturing of all
medical products. The Act requires us to register the facility, list devices,
file notice of intent to market new products, track the locations of certain
products and to report any incidents of death or serious injury relating to the
products with the FDA. We are subject to civil and criminal penalties and/or
recall seizure or injunctions if we fail to comply with regulations of the FDA.
The most recent Form 510(k) filings with the FDA were for the resuscitator and
the vacuum erection device and constriction rings, both approved in 1998.
8
We are required to comply with federal, state and local environmental laws;
however, there is no significant effect of compliance on capital expenditures,
earnings or competitive position. We do not use significant amounts of hazardous
materials in the assembly of these products.
Periodically we are subject to inspections and audits by FDA inspectors. During
the year ended February 28,2002, we were subject to an audit that was triggered
by a recall. The FDA issued the Company a 483 at the end of the audit, which we
responded to, and the FDA accepted the response. The FDA will verify our
accepted response on their next inspection, which could occur at any time. As a
result of FDA audits, the Company may be subject to further audits and may be
impacted by adverse findings.
PATENTS AND TRADEMARKS
We have filed and received U.S. protection for many of our products and in some
cases, where it was no longer deemed economically beneficial, we have allowed
certain patent protections to lapse. The RES-Q-VAC, an emergency medical
product, is susceptible in the international market to imitation. A competitor
has introduced a competitive product to the RES-Q-VAC into the market within the
last year. We have responded with the introduction of new innovative features
for the RES-Q-VAC that enhances the product and places it steps above the
competition in safety.
On April 10, 2001, we submitted a patent application for our new Full Stop
Protector. This addition to the RES-Q-VAC system prevents any fluids from
exiting the system. It also serves to trap airborne and fluid pathogens. We
believe that the addition of the flow block design substantially separates the
RES-Q-VAC from competitive units, which tend to leak fluid when becoming full or
could pass air born pathogens during use. There is a heightened concern from
health care professionals concerning exposure to disease and the new RES-Q-VAC
provides improved protection for these users.
OSHA 29CFR 1910.1030 - Occupational Exposure to Bloodborne Pathogens requires
that employers of "...emergency medical technicians, paramedics, and other
emergency medical service providers; fire fighters, law enforcement personnel,
and correctional officers...must consider and implement devices that are
appropriate [to contain bloodborne pathogens], commercially available and
effective." These first responders risk exposure to serious disease, and the
employers may risk OSHA violations and lawsuits if they fail to consider
protective measures such as Repro-Med's Full Stop Protection for RES-Q-VAC The
Company has received a letter from OSHA indicating the RES-Q-VAC meets the
intent of this regulation.
The most recent patent granted to us was # 5,336,189 for a "Combination IV Pump
& Disposable Syringe" which confers a unique syringe to IV pump interface
design. This patent is for the FREEDOM60 Infusion System, an infusion therapy
product. The cost of filing and maintaining applications has deterred pursuing
international patents.
The patent position of small companies is highly uncertain and involves complex
legal and factual questions. Consequently, there can be no assurance that patent
applications relating to products or technology will result in patents being
granted or that, if issued, the patents will afford protection against
competitors with similar technology.
9
Furthermore, some patent licenses held may be terminated upon the occurrence of
certain events or become non-exclusive after a specified period. There can be no
assurance that we will have the financial resources necessary to enforce any
patent rights we may hold.
Our product names are registered trademarks. There can be no assurance that
patents or trademarks will provide competitive advantages for the products
covered or that they will not be challenged or circumvented by competitors.
Item 2. Description of Property
In February 1999, we executed a sale-leaseback for our masonry and steel frame
building erected on 3.27 acres of land located at 24 Carpenter Road, Chester,
New York 10918. The facility is the only location and is used for our
headquarters and manufacturing operations.
Under terms of the contract of sale, we have the option to re-purchase the
building, beginning on the second anniversary of the sale and ending on the
eighth anniversary. We are required to give 12 months prior notice of the intent
to re-purchase the building. The agreed upon amount for re-purchase is as
follows:
Year Four $2,205,000 Year Five $2,315,250
Year Six $2,431,013 Year Seven $2,552,563
The property is currently subject to a 20-year lease. We are responsible for
repairs, maintenance and upkeep of the space we occupy. The terms of the lease
call for monthly lease payments of $10,000 per month and 65% of the annual
property taxes that amounted to $40,614 for the year ended February 28, 2002.
Our monthly rent is $10,000 for the first 10 years of the lease and $11,042
thereafter.
Item 3. Legal Proceedings
We are not a party to any material litigation, nor to the knowledge of the
officers and directors, is there any material litigation threatened against us.
Item 4. Submission of Matters to a Vote of Security Holders
No matters were submitted to a vote of security holders during the fiscal year
ended February 28, 2002.
PART II
Item 5. Market for the Registrant's Common Equity and Related Shareholder
Matters
We are authorized to issue 50,000,000 shares of Common Stock, $.01 par value. As
of February 28, 2002, 23,504,000 shares were issued and outstanding and there
were approximately 1,160 holders of record.
Our Common Stock is traded in the over-the-counter market and is quoted through
the National Daily Quotation Service. The following table sets forth the high
and low closing bid quotations for the Common Stock as reported by the National
Quotation Bureau, Inc. for the periods indicated. These quotations represent
interdealer prices, without retail mark-up, markdown or commission and may not
represent actual transactions.
10
Year Ended February 28, 2001: High Bid Low Bid
----------------------------- -------- -------
1st Quarter ................ $ 0.280 $ 0.280
2nd Quarter ................ $ 0.490 $ 0.450
3rd Quarter ................ $ 0.160 $ 0.160
4th Quarter ................ $ 0.180 $ 0.150
Year Ended February 28, 2002
----------------------------
1st Quarter ................ $ 0.260 $ 0.150
2nd Quarter ................ $ 0.230 $ 0.110
3rd Quarter ................ $ 0.230 $ 0.110
4th Quarter ................ $ 0.140 $ 0.070
On February 2, 1993 we issued 10,000 shares of 8% Cumulative Convertible
Preferred Stock in a private placement for $100,000. We are obligated to pay
semi-annual dividend payments of $4,000 until conversion by shareholders or
redemption by us. The 10,000 shares of Cumulative Convertible Preferred Stock
are convertible to 294,117 shares of Repro-Med common stock at $0.36 per share.
The 10,000 shares of Cumulative Convertible Preferred Stock are convertible
based on the following formula: multiply the number of shares of Preferred Stock
to be converted by $10.00, divide the result by the conversion price of $0.20
per share (or by the conversion price as last adjusted and in effect at the date
any shares are surrendered for conversion). The Conversion Price shall increase
by $.02 for each year that the Preferred Stock is outstanding. The current
conversion price is $.38.
We have not declared or paid any cash dividends on our Common Stock and do not
anticipate that any dividends will be paid in the foreseeable future. During the
fiscal year ended February 28, 2002, dividend payments on the Convertible
Preferred Stock amounted to $8,000 and an additional $4,000 were accrued on the
balance sheet.
Item 6. Management's Discussion and Analysis of Financial Condition and Results
of Operations
This Annual Report on Form 10-KSB contains certain "forward-looking" statements
(as such term is defined in the Private Securities Litigation Reform Act of
1995) and information relating to us that are based on the beliefs of the
management, as well as assumptions made by and information currently available.
Our actual results may vary materially from the forward-looking statements made
in this report due to important factors such as, recent operating losses,
uncertainties associated with future operating results, unpredictability related
to Food and Drug Administration regulations, introduction of competitive
products, limited liquidity, reimbursement related risks, government regulation
of the home health care industry, success of the research and development
effort, market acceptance of FREEDOM60, availability of sufficient capital to
continue operations and dependence on key personnel. When used in this report,
the words "estimate," "project," "believe," "anticipate," "intend," "expect" and
similar expressions are intended to identify forward-looking statements. Such
statements reflect current views with respect to future events based on
currently available information and are subject to risks and uncertainties that
could cause actual results to differ materially from those contemplated in such
forward-looking statements. Readers are cautioned not to place undue reliance on
these forward-looking statements, which speak only as of the date hereof.
11
These statements involve risks and uncertainties with respect to the ability to
raise capital to develop and market new products, acceptance in the market place
of new and existing products, ability to penetrate new markets, our success in
enforcing and obtaining patents, obtaining required Government approvals and
attracting and maintaining key personnel that could cause the actual results to
differ materially. Repro-Med does not undertake any obligation to release
publicly any revision to these forward-looking statements to reflect events or
circumstances after the date hereof or to reflect the occurrence of
unanticipated events.
RESULTS OF OPERATIONS
2002 vs. 2001
For the year ended February 28 , 2002 we showed a loss of $386,075 as compared
to a loss for the previous year of $104,457. This decline was mainly a result of
a decrease in total net sales for the year ended February 28,2002 due to a
reduction in sales for less profitable products.
Sales of our key products have significantly increased this year. Sales of the
Freedom60 Syringe Infusion System increased by 37% over the prior year and sales
of our RES-Q-VAC Airway Suction System increased by 13% over the prior year.
These sales increases were offset by the elimination of low margin products and
recognition of an OEM sale, which resulted in overall sales this year decreasing
16% to $1,758,904 for 2002 from $2,085,912 for 2001. Without the OEM sale
recognized during fiscal year 2001, net sales would have decreased by only 4%
overall as a result of the elimination of low margin products offset by
significant increases in our key products.
The company has recently added a new Full Stop Protector to the RES-Q-VAC, which
protects the users from any contamination from overflow and traps all pathogens
inside the suction container. This new feature is also a requirement of the
Occupational Safety and Health Administration under OSHA 29CFR 1910.1030 -
Occupational Exposure to
Bloodborne Pathogens. The RES-Q-VAC is the only hand-held non-electric suction
system with sterile catheters for infants, large catheters for adults, and meets
the intent of the OSHA requirements with the Full Stop Protection device. The
Company has recently received a letter from OSHA confirming that the Full Stop
Protector falls under the engineering controls of the Bloodborne Pathogen
regulation and therefore would be required by any employer of medical personnel
to protect their employees from potentially infectious materials.
In August 2001, we received our first military order for the RES-Q-VAC from one
base location of the US Air Force. We received several small orders from other
bases during the last half of the year for RES-Q-VAC under their existing
AFMLO/VA contract. The company anticipates additional orders will be placed
during Fiscal year 2003.
Management is seeking funds to design a new improved RES-Q-VAC suction device to
expand the market substantially, although there is no assurance that such
funding can be obtained, or obtained at terms acceptable to us, or that if
funded, the markets would develop as expected. We are also planning to further
promote the RES-Q-VAC in the home care market, for which the RES-Q-VAC is
ideally suited due to its low cost, portability and convenience.
12
We have been marketing FREEDOM60 directly to national providers, other
distributors, and regional home care agencies. Sales of FREEDOM60 are expected
to continue to improve as new pump sales and restocking orders for disposables
are received. Furthermore, we are negotiating with a national distributor, which
would additionally improve sales potential for the line.
In September 2001, the Company began selling to a major national home care
agency that anticipates expanding the use of the FREEDOM60 to its regional
centers across the country. Currently three centers of the agency are using the
FREEDOM60 and four others are on trials. We anticipate starting trials in the
remaining centers within the next six to twelve months. We have also begun sales
into Europe with an Italian master distributor who arranged for CE approval of
the FREEDOM60.
Gross profit decreased to 25% of net sales for the year ended February 28,2002
from 38% for the year ended February 28,2001 primarily as a result of the timing
of the recognition of an OEM sale during the year ended February 28,2001. When
excluding this OEM sale for the year ended February 28,2001, the current gross
profit percentage is indicative of our current core business.
Selling, General & Administrative Expenses (SG&A) decreased year over year 2%
primarily as a result of a reduction in administrative personnel.
Research and development increased 14% to $40,835 from $35,843 as a result of
the use of outside engineering personnel during the year and for final
developments on the Full Stop Protection device for the RES-Q-VAC.
Net loss increased 270% to $386,075 for the year ended February 28,2002 from
$104,457 for the year ended February 28,2001, primarily as a result of the
decrease in net sales for the year ended February 28,2002.
For the year ending February 28, 2002, one customer's, Timm Medical, sales were
16% of the total sales. Management has been informed that Timm Medical has
sufficient inventory on hand to cover sales through September and that future
orders will be at a significantly reduced rate. As a result management has
decided to shift Company focus to its own proprietary products and markets.
LIQUIDITY AND CAPITAL RESOURCES
At the end of fiscal year 2002, we had net working capital of $183,120 a
decrease of $348,225 from the previous year.
During June 2000, we negotiated a $200,000 line of credit with M&T Bank that is
guaranteed by the President and one of the directors. As of February 28,2002,
$200,000 has been advanced on the line of credit. In accordance with the
agreement the line of credit was to be renewed or paid off by June 30, 2001. We
have received a verbal continuance from the bank through June 30,2002.
We negotiated a settlement with a lender that was remitted on October 29, 1999.
As part of the agreement, we signed a promissory note for $66,000 that becomes
due through October 2002 only upon the sale of either of our two major product
lines. If neither of the two product lines is sold, the note payable terminates.
13
We maintained our operations during Fiscal Year 2002 by borrowing approximately
200,000 from outside sources. We are attempting to achieve positive cash flow by
continuing to increase sales for the FREEDOM60 and RES-Q-VAC, decreasing
material costs and by pursuing capital investment through debt or equity. The
Company is working with outside distributors to increase market share in the
European markets for the RES-Q-VAC, and to introduce the FREEDOM60 into the
European market. We are in the process of validating new lower-cost and more
efficient vendors for our raw materials, which will assist us in improving our
margins on our current products. Sales of our key products increased
significantly for the first quarter ended May 31,2002 versus the prior year
first quarter ended May 31,2001. Sales of the Freedom60 Syringe Infusion System
increased by 31% over the prior year and sales of our RES-Q-VAC Airway Suction
System increased by 37% over the prior year. Total sales for the first quarter
ended May 31,2002 were the same as the first quarter ended May 31,2001 despite
the loss in sales of $81,000 from a major OEM customer for the first quarter
2002 and reduced sales for a low margin product line that we have been phasing
out over the last year.
Accounts Receivable decreased at February 28, 2002 to $190,938 as compared to
$207,588 for the previous year. Domestic sales are made primarily on net 30-day
payment terms. A variety of terms continue to be employed for export sales
including cash prepayments and net 45 days to allow for increased delays due to
transportation and communications. As of February 28, 2002, 69% of Accounts
Receivable were current, 25% were at 30-59 days and 6% were over 60 days.
Prepaid expenses and other receivables decreased $26,680 from $39,587 to
$12,907.
Capital expenditures in 2002 were $80,927 as compared to $73,060 in 2001. We
purchased tooling and a new phone system through outside leasing programs. Other
assets decreased $1,012.
In February 1999, we executed a sale-leaseback for our masonry and steel frame
building erected on 3.27 acres of land located at 24 Carpenter Road, Chester,
New York 10918. The facility is our only location and is used for our
headquarters and manufacturing operations.
Under terms of the contract of sale, we have the option to re-purchase the
building, beginning on the second anniversary of the sale and ending on the
eighth anniversary. We are required to give 12 months prior notice of the intent
to re-purchase the building. The agreed upon amount for re-purchase is as
follows:
Year Four $2,205,000 Year Five $2,315,250
Year Six $2,431,013 Year Seven $2,552,563
The property is currently subject to a 20-year lease. We are responsible for
repairs, maintenance and upkeep of the space occupied. The terms of the lease
call for monthly lease payments of $10,000 per month and 65% of the annual
property taxes that amounted to $40,614 for the year ended February 28, 2002.
Our monthly rent is $10,000 for the first 10 years of the lease and $11,042
thereafter.
14
SUBSEQUENT EVENTS
NEW BOARD OF DIRECTOR MEMBERS
During March 2002, the Board agreed to elect two new Board members; Joseph
Drohan and David Florman.
Mr. Drohan is the President and Co-Founder of Healthwave, Inc. , healthcare
technology and services company, located in Long Island, New York. He held
several positions with the North Shore Long Island Jewish Health System and has
been a Director for various health organizations.
Mr. Florman is currently employed by Empire Blue Cross Blue Shield of New York
as the Senior Vice President of Medical Delivery and Medicare Risk. He has held
various positions with Aetna US Healthcare, Inc. as well.
2001 vs. 2000
For the year ended February 28, 2001 we showed a loss of $104,457 as compared
to a profit for the previous year of $250,300. This decline was mainly a result
of equity based compensation of $133,000 associated with the issuance of stock
and stock options for services rendered, during the year ended February 28,
2001, coupled with the sale of a subsidiary, and a favorable debt settlement of
a line a credit for the year ended February 29, 2000.
Total net sales increased slightly to $2,085,912 from $2,065,400. FREEDOM60
sales increased 17% to $146,111 from $125,021, RESTORE sales increased 111% to
$64,360 from $30,483 and OEM sales increased 15% to $569,839 from $493,378.
Resuscitator sales decreased 31% to $160,790 from $233,336, GYNECO sales
decreased 7% to $203,611 from $219,851 and RES-Q-VAC sales decreased a slight 2%
to $947,019 from $963,341.
Cost of Goods Sold (COGS) decreased 2% to $1,106,972 from $1,125,552 due to
improved manufacturing processes, aggressive purchasing, and other production
efficiencies.
Selling, General & Administrative Expenses (SG&A) decreased year over year 18%
primarily as a result of decreased payroll due to reductions in management
staff.
Research and development decreased 56% to $35,335 from $80,944. Factors in this
decrease were due to a salary reduction, the departure of a senior engineer, and
a planned decrease in new products until we experience an improvement in
available capital. We have placed development and research on hold pending the
infusion of new investment capital for such programs.
Net loss for operations decreased 57% to $102,351 from $237,337, which was
primarily the result of decreased payroll, decreased research & development and
a decrease in overall spending for the period.
Non-operating income decreased significantly to ($2,106) from $370,745 primarily
resulting from the sale of the Gamogen subsidiary and the joint venture for
RESTORE in the previous year. The current year non-operating income and expense
consisted primarily of interest expense for the credit line and equipment lease
and interest and other income.
15
For the year ending February 28, 2001, there were two customers whose combined
sales were 27% of the total sales, Timm Medical and Mission Pharmacal. Sales are
expected to continue with Timm Medical, however, Mission has advised us that
they have reduced market support of their product and no additional purchases
are anticipated for the fiscal year ending 2002.
On August 28, 2000, we were notified of an Indefinite Delivery, Indefinite
Quantity (IDIQ) Contract #RFP-797-FDF3-00-0089 awarded on August 25, 2000 by the
AFMLO/VA Services Division. This material contract covers three of the Company's
patented products, RES-Q-VAC Manual Suction System, FREEDOM60 Syringe Infusion
System and Masterson Endometrial Biopsy System, which are now available to all
government agencies. We continue in the process of contacting the various
branches of the government that have continued to express interest in these
products.
On September 29, 2000, we were notified that the U. S. Defense Logistics
Information Service in Battle Creek, MI had assigned National Stock Numbers to
our FREEDOM60 and RES-Q-VAC products and accessories. This now facilitates
orders from any U. S. military agency to be able to acquire our products from a
national military catalog listing.
On November 5th, 2000, the Health Care Financing Administration (HCFA) had
advised us that after the ninety day review process of our application, the
SADMERC and the four Durable Medical Equipment Regional Carriers DMERCs)
completed the HCPCS coding re-review and advised us that the correct billing
code for the RES-Q-VAC was E1399, a durable equipment miscellaneous
reimbursement code. Subsequently, three weeks later HCFA advised us that it was
rescinding the previous correspondence because we didn't prove the use of
RES-Q-VAC in a home setting. The Company is gathering further information and
home care user testimonials. Once we have secured sufficient testimonials we
will reapply.
16
Item 7. Financial Statements
Index to Financial Statements and Supplementary Data
Page
----
Report of Independent Certified Public Accountants ................ 18
Financial Statements:
Balance Sheet, February 28, 2002 .................................. 19
Statements of Income, For the Years Ended
February 28, 2002 & February 28, 2001 ........................... 20
Statements of Changes in Stockholders' Equity,
For the Years Ended February 28, 2002 and February 28, 2001 ..... 21
Statements of Cash Flows, For the Years Ended
February 28, 2002 & February 28, 2001 ........................... 22
Notes to Financial Statements ..................................... 23
17
INDEPENDENT AUDITORS' REPORT
BOARD OF DIRECTORS
REPRO-MED SYSTEMS, INC.
We have audited the accompanying balance sheet of Repro-Med Systems,
Inc. as of February 28, 2002 and the related statements of operations;
stockholders' equity and cash flow for each of the two years then ended. 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 audit.
We conducted our audit in accordance with auditing standards generally
accepted in the United States. Those standards require that we plan and perform
the audit to obtain reasonable assurance about whether the financial statements
are free of material misstatement. An audit includes examining, on a test basis,
evidence supporting the amounts and disclosures in the financial statements. An
audit also includes assessing the accounting principles used and significant
estimates made by management, as well as evaluating the overall financial
statement presentation. We believe that our audit provides a reasonable basis
for our opinion.
In our opinion, the financial statements referred to above present
fairly, in all material respects, the financial position of Repro-Med Systems,
Inc. as of February 28, 2002 and the results of their operations and their cash
flows for each of the two years then ended, in conformity with accounting
principles generally accepted in the United States.
The accompanying financial statements have been prepared assuming that
the Company will continue as a going concern. The Company has suffered from
recurring losses from operations, including net losses of $386,075 and $104,457
for the years ended February 28,2002 and 2001, respectively. These factors raise
substantial doubt about the Company's ability to continue as a going concern.
The financial statements do not include any adjustments that might result from
the outcome of this uncertainty.
/s/ Radin, Glass & Co., LLP
New York, NY
April 15, 2002
18
Repro-Med Systems, Inc.
Balance Sheet
ASSETS February 28, 2002
- ------ -----------------
CURRENT ASSETS
Cash ......................................................... $ 25,670
Accounts Receivable, net ..................................... 190,938
Inventory .................................................... 600,635
Prepaid Expenses & Other Receivables ......................... 12,907
------
TOTAL CURRENT ASSETS ............................................. 830,150
-------
EQUIPMENT & OTHER ASSETS
Equipment-net ................................................ 467,985
Other Assets ................................................. 49,064
Deposits ..................................................... 52,000
TOTAL EQUIPMENT & OTHER ASSETS ................................... 569,049
-------
TOTAL ASSETS ..................................................... $ 1,399,199
===========
LIABILITIES & STOCKHOLDERS' EQUITY
- ----------------------------------
CURRENT LIABILITIES
Accounts Payable ............................................. $ 189,111
Demand Loan from President ................................... 69,000
Bank Line of Credit Payable .................................. 200,000
Accrued Expenses ............................................. 144,792
Current Portion of Capital Gain .............................. 22,481
Current Portion of Leases Payable ............................ 21,646
------
Total Current Liabilities ........................................ 647,030
Deferred Capital Gain ....................................... 359,695
Long Term Leases Payable ......................................... 55,098
------
TOTAL LIABILITIES ................................................ 1,061,823
---------
COMMITMENTS AND CONTINGENCIES .................................... 0
-
STOCKHOLDERS' EQUITY
Preferred Stock, 8% Cumulative $.01
Par Value Authorized 2,000,000 Issued &
Outstanding 10,000 Shares (liquidation value $100,000) ....... 100
Common Stock, $.01 Par Value,
Authorized 50,000,000 Shares, Issued &
Outstanding 23,504, 000
Respectively ................................................. 235,040
Additional Paid-in Capital ................................... 2,211,631
Accumulated Deficit .......................................... (1,967,395)
Treasury Stock at Cost ....................................... (142,000)
--------
TOTAL STOCKHOLDERS' EQUITY ....................................... 337,376
-------
TOTAL LIABILITIES & STOCKHOLDERS' EQUITY ......................... $ 1,399,199
===========
*See accompanying notes to consolidated financial statements
19
Repro-Med Systems, Inc.
Statements of Operations
For The Years Ended
February 28, February 28,
2002 2001
---- ----
Sales
Net Sales of Products ...................... $ 1,758,904 $ 2,085,912
Costs and Expenses:
Cost of Goods Sold ......................... 1,330,960 1,286,475
Selling, General & Administrative .......... 635,530 647,974
Research & Development ..................... 40,835 35,843
Depreciation & Amortization ................ 84,839 84,971
Equity Based Compensation .................. 41,000 133,000
------ -------
Total Costs And Expenses ..................... 2,133,164 2,188,263
Net Operating Loss ........................... (374,260) (102,351)
Non-Operating Income (Expense)
Interest Expense ........................... (20,252) (5,483)
Interest & Other Income .................... 9,009 3,377
----- -----
Total Non-Operating Income (Expense) ........ (11,243) (2,106)
------- ------
(Loss) before Taxes ........................ (385,503) (104,457)
(Provision) Benefit for Income Taxes ....... (572) 0
---- -
Net (Loss)
(386,075) (104,457)
Preferred Dividend ........................... (12,000) (8,000)
------- ------
Net (Loss) Available to
Common Shareholders .......................... ($ 398,075) ($ 112,457)
============ ============
Weighted average number of shares outstanding
Basic ...................................... 23,504,000 23,354,000
Diluted .................................... 23,504,000 23,354,000
(Loss) Per Common Share
Basic- ..................................... ($ 0.02) ($ 0.00)
Diluted .................................... ($ 0.02) ($ 0.00)
*See accompanying notes to consolidated financial statements
20
Repro-Med Systems, Inc.
Statement of Changes in Stockholders' Equity
For the Years Ended February 28, 2002 & February 28, 2001
* See accompanying notes to financial statements
21
Repro-Med Systems, Inc
Statements of Cash Flows
For the Years Ended
February 28, February 28,
2002 2001
---- ----
CASH FLOWS FROM OPERATING ACTIVITIES
Net (Loss) ....................................... ($386,075) ($104,457)
Adjustments to reconcile net (loss) to cash
used in operating activities:
Equity Based Compensation ................... 41,000 133,000
Depreciation and Amortization ............... 84,839 84,971
Deferred gross profit - building lease ...... (22,481) (22,481)
Accounts Receivable ......................... 16,649 20,283
Inventories ................................. (13,769) (30,984)
Prepaid Expenses ............................ 26,680 (6,070)
Other Assets ................................ 1,012 4,336
Accounts Payable ............................ 86,974 42,774
Accrued Expenses ............................ 12,358 (52,501)
Demand Loan from President .................. 69,000 0
Leases Payable .............................. 39,714 37,029
Customers Deposits .......................... (2,770) (242,460)
------ --------
NET CASH USED BY OPERATIONS ...................... (46,869) (136,560)
------- --------
CASH FLOWS USED BY INVESTING ACTIVITIES
Capital Expenditures ........................ (80,927) (73,060)
------- -------
NET CASH USED BY INVESTING ACTIVITIES ......... (80,927) (73,060)
------- -------
CASH FLOW PROVIDED BY FINANCING
ACTIVITIES:
Proceeds from line of credit .................. 130,000 70,000
Preferred stock dividends ........................ (12,000) (4,000)
Issuance of Common Stock/Exercise of Options .. 0 12,000
- ------
NET CASH PROVIDED BY (USED IN) FINANCING
ACTIVITIES ..................................... 118,000 78,000
------- ------
NET DECREASE IN CASH ............................. (9,796) (131,620)
CASH, beginning of period ........................ 35,466 167,085
------ -------
CASH, end of period .............................. $ 25,670 $ 35,466
========= =========
Supplemental disclosures of Cash Flow Information:
Interest ...................................... $ 20,252 $ 5,483
Income Taxes .................................. 572 0
*See accompanying notes to financial statements
22
Repro-Med Systems, Inc.
Notes To Consolidated Financial Statements
For the Two Years Ended, February 28, 2002 and February 28, 2001
Note 1 - Organization and Summary of Significant Accounting Policies
(A) Repro-Med Systems, Inc. was incorporated on March 24, 1980. The Company
was organized to engage in the research, development, laboratory and
clinical testing, production and marketing of medical devices used in
the treatment of the human condition.
(B) The accompanying financial statements have been prepared assuming that
the Company will continue as a going concern. The Company has suffered
recurring losses at February 28,2002 and 2001. These factors raise
substantial doubt about the Company's ability to continue as a going
concern. The financial statements do not include any adjustments that
might result from the outcome of this uncertainty. The Company's
independent certified public accountants have included a modification
paragraph in their report on the Company's financial statements for the
year ended February 28,2002 with respect to this matter. The Company
intends to raise additional financing through debt or equity to enable
the Company to continue for at least one year. The Company is also
working with outside distributors to increase market share in the
European markets for the RES-Q-VAC, and to introduce the FREEDOM60 into
the European market.
(C) Revenue is recognized when products are shipped.
(D) Costs incurred in obtaining patents have been capitalized and are being
amortized over seventeen years. Costs of goodwill have been capitalized
and are being amortized over thirty-five years.
(E) Furniture and equipment is stated at cost. Furniture and equipment is
being depreciated over five to twelve years utilizing the straight-line
method of depreciation.
(F) Inventory is valued at the lower of cost (first-in, first-out method),
or market.
(G) The Financial Statements are presented in accordance with SFAS No. 128
"Earnings Per Share". Basic earnings per share are computed using the
weighted average number of common shares outstanding during the period.
Diluted earnings per share incorporate the shares to be issued assuming
exercise of warrants and options. The loss per common share does not
include the conversion of outstanding options and warrants since all of
the stock options and warrants outstanding are anti-dilutive.
(H) Cash and cash equivalents are comprised of certain highly liquid
investments with maturities of three months or less.
(I) Use of estimates - the Financial Statements are prepared in conformity
with generally accepted accounting principles and, accordingly include
amounts that are based on management's best estimates and judgments.
The actual results may differ from those estimates.
(J) Reclassification - certain reclassifications have been made to prior
year amounts to conform to current year presentation.
23
(K) The carrying amounts reported in the balance sheet for cash,
receivables, and accrued expenses approximate fair value based on the
short-term maturity of these instruments.
(L) The Company accounts for employee stock options in accordance with APB
Opinion No. 25, "Accounting for Stock Issued to Employees" and has
adopted the disclosure-only option under SFAS No. 123.
(M) The Company utilized the liability method of accounting for income
taxes as set forth in SFAS 109, "Accounting for Income Taxes." Under
the liability method, deferred taxes are determined on the difference
between the financial statement and tax bases of assets and liabilities
using enacted tax rates in effect in the years in which the differences
are expected to reverse.
(N) In August 2001, the FASB issued SFAS No. 144, "Accounting for the
Impairment or Disposal of Long-Lived Assets" which basically further
clarifies SFAS No. 121 and methods of quantifying potential impairments
or disposal of assets as well as the related reporting of such
impairments or disposals. The Company reviews long-lived assets,
certain identifiable assets and any goodwill related to those assets
for impairment. Whenever circumstances and situations change such that
there is an indication that the carrying amounts may not be
recoverable. At February 28,2002, the Company believes that there has
been no impairment of long-lived assets.
(O) New Accounting Developments:
In June 2001, the FASB issued SFAS No. 141, "Business Combination",
SFAS No. 142, "Goodwill and Other Intangible Assets" and SFAS No. 143,
"Accounting for Asset Retirement Obligations". SFAS No. 141 requires
the use of the purchase method of accounting and prohibits the use of
the pooling-of-interest method of accounting for business combinations
initiated after June 30, 2001. It also requires that the Company
recognize acquired intangible assets apart from goodwill. SFAS No. 142
requires, among other things, that companies no longer amortize
goodwill, but instead test goodwill for impairment at least annually.
In addition, SFAS No. 142 requires that the Company identify reporting
units for the purposes of assessing potential future impairments of
goodwill, reassess the useful lives of other existing recognized
intangible assets, and cease amortization of intangible assets with an
indefinite useful life. SFAS No. 143 establishes accounting standards
for recognition and measurement of a liability for an asset retirement
obligation and the associated asset retirement cost, which will be
effective for financial statements issued for fiscal years beginning
after June 15, 2002.
The adoption of SFAS No. 141, SFAS No. 142, SFAS No. 143 and SFAS No. 144 is not
expected to have a material effect on the Company's financial position, results
of operations and cash flows.
24
Note 2 - Inventory
Inventory Consists of:
Raw Materials $ 315,808
Work In Process 185,474
Finished Goods 139,353
Inventory Reserve (40,000)
-------
Total $ 600,635
=========
Note 3 - Equipment and Other Assets
Equipment:
Furniture and Equipment $ 1,176,302
Accumulated Depreciation (708,317)
--------
Net Equipment $ 467,985
===========
Other Assets:
Patent Costs $ 95,551
Goodwill 14,137
Miscellaneous 802
Accumulated Amortization (61,426)
-------
Net Other Assets $ 49,064
===========
Note 4 - Line of Credit
The company had a line of credit of $200,000 for fiscal year ended February 28,
2002. At February 28, 2002, $200,000 has been advanced on the line of credit.
Although the line matured on June 30,2001, during January 2002, the bank
verbally extended the term of the line through June 30,2002. The President of
the Company and one of the Directors guarantee such credit line.
Note 5 - Capital Lease
The Company leases certain equipment under leases accounted for as capital
leases. The following is a summary of aggregate annual maturities of long-term
debt and capitalized lease obligations as of February 28,2002.
Year ending February 28,
2003 $30,676
2004 $30,676
2005 $20,820
2006 $15,892
2007 $ 5,590
Less amounts representing interest (26,910)
-------
76,744
Less current portion (21,646)
-------
$55,098
=======
25
Note 6 - Capitalization and Certain Capital Transactions
On February 2, 1993, the Company issued and sold 10,000 shares of $.01 par value
Convertible Cumulative Preferred Stock at a price of $10.00 per share. Dividends
are payable semi-annually at an annual rate of $8,000 or 8% of the original sale
price of $100,000. As of February 28, 2002 the Convertible Cumulative Preferred
Stock can be converted to 294,117 shares of common stock at the conversion price
of 38 cents per share. Dividends of $8,000 were paid through February 28,2002
and an additional $4,000 were accrued on the Balance Sheet.
On October 31, 1995, the Company purchased in a private offering 275,000 shares
of common shares at a price of $0.08 per share or a total of $22,000. On
September 10, 1996, the Company purchased in a private offering 2,000,000 shares
of common shares at a price of $0.06 per share or a total of $120,000. The
2,275,000 shares redeemed were previously restricted in part as to their sale
under "Rule 144" of the Securities and Exchange Act. The 2,000,000 shares
redeemed are subject to a ten year voting agreement dated June 30, 1992 under
which Mr. Andrew I. Sealfon, President and Chairman of Repro-Med, has the
exclusive right to vote all the shares covered under the voting agreement. The
2,000,000 shares redeemed on September 10, 1996, while held by the Company, will
be voted exclusively by Mr. Sealfon until June 30, 2002 as required by the
voting trust. Treasury Stock shares may be sold at a future time or held by us
for corporate use.
The Company issued 500,000 performance based stock options during the year ended
February 28,2001 which were subsequently cancelled due to the termination of the
employee that was issued these options. In addition, the Company also issued
400,000 shares of stock options valued at $82,000, which has been amortized for
a period of twenty-four months. All unearned compensation has been amortized as
of February 28,2002.
Note 7 - Related Party Transactions
The Company leased an aircraft from the President for $21,500 and $20,000 at
February 28, 2002 and February 28, 2001.
The Company owes the President approximately $3,000 for repairs, in accordance
with the lease agreement, for the aircraft that it leases from the President.
The Company leased office space from the President for $6,000 during the years
ended February 28, 2002 and February 28, 2001.
The Company has borrowed $69,000 from the President, Andrew Sealfon, during
Fiscal Year 2002 under a demand loan with an annual interest rate of 8%. The
note has been approved by the Board of Director's.
Note 8 - Earnings Per Share
Basic earnings and losses per share are computed by dividing net earnings or
losses by the weighted average number of shares of Common Stock and Common Stock
Equivalents outstanding during the period (including 2,275,000 shares held as
treasury stock). Diluted earnings and losses per share are computed by dividing
net earnings or losses by the weighted average number of shares of Common Stock
and Common Stock Equivalents outstanding during the period (including 2,275,000
shares held as treasury stock) as if the excercisable options were converted
into common stock at the beginning of the period.
26
(Loss) Per Common Share
February 2002 February 2001
------------- -------------
Basic Per Share .............. ($0.02) ($0.00)
Number of Shares Primary ..... 23,504,000 23,354,000
Diluted Per Share ............ ($0.02) ($0.00)
Number of Shares Fully Diluted 23,504,000 23,354,000
Note 9 - Income Taxes
As of February 28, 2001 Repro-Med has a net operating loss carry forward ("NOL")
of approximately $1,450,000 available to offset its future income tax
liabilities. The NOL has expiration dates ranging from 2002 to 2022.
Temporary differences which give rise to deferred taxes are summarized as
follows:
February 2002 February 2001
------------- -------------
Deferred tax assets:
Net operating loss and
other carryforwards .......... $694,000 $540,000
Valuation Allowance .......... (694,000) (540,000)
-------- --------
Net deferred tax assets ...... $ 0 $ 0
=== ===
The Company has recorded a full valuation allowance to reflect the estimated
amount of deferred tax assets that may not be realized due to the lack of
taxable income being generated on a consistent basis.
The Company's effective income tax rate differs from the statutory Federal
income tax rate as a result of the following:
February 2002 February 2001
------------- -------------
Tax benefit at statutory rate ($151,000) ($35,000)
Non deductible expense ....... 14,000 31,000
State benefit, net of Federal
tax effect ................... (17,000) (4,000)
------- ------
Change in valuation allowance
on net operating loss ........ 154,000 8,000
------- -----
$ 0 $ 0
======== =======
27
Note 10 - Stock Option Plan
On March 1, 1995, the Board of Directors approved two incentive stock option
programs for the benefit of key employees, directors, and officers of the
Company. The two plans, termed the 1995 Stock Option Plan and the 1995 Stock
Option Plan For Non-Employee Directors (the "Option Plans"), provide options to
purchase 5,000,000 and 500,000 shares, respectively, of Repro-Med common stock.
We have filed a Registration Statement with the Securities and Exchange
Commission for the Option Plans. The Option Plans expire March 1, 2005. Options
granted under the 1995 Stock Option Plan to full time employees are intended as
"incentive stock options" within the meaning of Section 422A of the Internal
Revenue Code. On March 1, 1995, the Board of Directors voted to grant options
for 3,800,000 shares under the Option Plans. In May 2000, Marion Howarth
exercised 200,000 options under the plan. No other options under the plan have
been exercised as of February 28, 2002. During the year ended February 28,2002,
400,000 options were granted to employees and 190,000 were granted to
Director's. 100,000 to a new Director and 30,000 each to the three Director's
that were members of the board for the year ended February 28,2001. The employee
options vest over a period of five years beginning one year from the grant date
and are exercisable until one year from the date all options have vested. The
90,000 Director's options are exercisable immediately while the 100,000 options
for the new Director are exercisable in the same manner as the employee options.
All options were issued at fair market value on the date the options were
granted.
Stock option activity for the years ended February 28, 2001 and 2002 is
summarized as follows:
1995 Stock Option Plan:
Weighted
Average
Shares Exercise Price
--------- --------------
Outstanding at February 29, 2000 .. 2,200,000 $ .07
Granted ........................ 400,000 .21
Exercised ...................... (200,000) .06
Expired or cancelled
--------- --------------
Outstanding at February 28, 2001 .. 2,400,000 $ .09
--------- --------------
Granted ........................ 590,000 .20
Exercised ...................... 0
Expired or cancelled ........... 0
--------- --------------
Outstanding at February 28, 2002 .. 2,990,000 $ .11
========= ==============
28
Non - Qualified Stock Options:
Weighted
Average
Shares Exercise Price
--------- --------------
Outstanding at February 29, 2000 150,000 $ 1.00
Granted ..................... 985,000 .20
Exercised ................... - -
Expired or cancelled ........ - -
--------- --------------
Outstanding at February 28, 2001 1,135,000 .30
--------- --------------
Granted...................... - -
Exercised ................... - -
Expired or cancelled ........ (500,000) -
--------- --------------
Outstanding at February 28, 2002 635,000 $ .38
========= ==============
Information, at date of issuance, regarding stock option grants for the year
ended February 28, 2001 and 2002:
Weighted Weighted
Average Average
Exercise Fair
Shares Price Value
------ ----- -----
Year ended February 28, 2001:
Exercise price exceeds market price........... - $ - $ -
Exercise price equals market price ........... 1,200,000 .22 .08
Exercise price is less than market price ..... 185,000 .10 .18
Year ended February 28, 2002:
Exercise price exceeds market price........... - $ - $ -
Exercise price equals market price ........... 590,000 .20 .13
Exercise price is less than market price ..... - - -
For disclosure purposes in accordance with SFAS No. 123, the fair value of each
stock option grant is estimated on the date of grant using the Black-Scholes
option-pricing model with the following weighted-average assumptions used for
stock options granted during the year ended February 28, 2002 and 2001: annual
dividends of $0.00, expected volatility of 97% at February 28, 2002 and 2001,
risk-free interest rate of 5.75% and expected life of three years for all
grants.
If the Company recognized compensation cost for the vested portion of the
employee stock option plan in accordance with SFAS No. 123, the Company's
pro-forma net (loss) and income per share for the years ended February 28, 2002
and 2001, would have been approximately, ($469,124) and ($.02), ($120,457) and
$.01, respectively.
The non-qualified stock options outstanding are partially vested. The
compensation expense attributed to the issuance of these stock options has been
amortized and expensed over 24 months. These stock options are exercisable for
three years from the grant date. The employee stock option plan stock options
are exercisable for ten years from the grant date and vest over three years. As
of February 28, 2002 and 2001, and 2,200,000, respectively, of these stock
options were vested or earned.
29
The following table summarizes information about warrants outstanding and
exercisable at February 28, 2002:
Outstanding
----------------------------------------------
Weighted- Weighted-
average average
remaining exercise
Range of exercise prices Shares life in years price
- ------------------------ ------ ------------- -----
$ .01 to $ .10 2,185,000 2.87 $ .06
$ .11 to $ .50 1,315,000 3.48 .22
$ .61 to $1.00 50,000 1.00 .80
$1.01 to $3.00 75,000 1.00 1.30
---------
3,625,000
=========
Note 11 - Sale-Leaseback Transaction - Operating Lease
On February 25, 1999, the company entered into a sale-leaseback arrangement.
Under the arrangement, the company sold its land and building at 24 Carpenter
Road, in Chester, New York and leased it back for a period of 20 Years. The
leaseback has been accounted for as an operating lease. The gain of $449,617
realized in this transaction has been deferred and will be amortized to income
in proportion to rental expense over the term of the lease.
At February 28, 2002 the future minimum rental payments are:
Year Minimum rental payments
- ---- -----------------------
2003 $ 120,000
2004 120,000
2005 120,000
2006 120,000
2007 120,000
thereafter $1,565,000
----------
Total $2,165,000
Note 12 - Major Customer
In the year ended February 28, 2002 there was one customer that accounted for
16% of the total sales. Historically, the Company used these OEM sales profits
to fund internal product development that resulted in the RES-Q-VAC and
FREEDOM60. While the Company still entertains, from time to time, various
contract manufacturing, the Company is transitioning from these contracts to
building and selling its own proprietary products due to the much improved
margins associated with directly marketed devices.
Item 8. Changes in and Disagreements with Accountants on Accounting and
Financial Disclosure
None
30
PART III
Item 9. Directors and Executive Officers, Promoters and Control Persons:
Compliance With Section 16(a) of the Exchange Act
The following table sets forth-certain information with respect to the
Executive Officers and Directors:
Name Age Position/Held Since
---- --- -------------------
Andrew I. Sealfon 56 President 1980,
Treasurer 1983,
Chairman 1989,
Director 1980
CEO 1986
Paul Mark Baker 52 Director 1991
Nathan Blumberg 67 Director 2000
Joseph Rosen 52 Director 2001
Remo Spagnoli 73 Director 1993
Joseph Drohan 49 Director 2002
David Florman 49 Director 2002
Mr. Sealfon is deemed a "parent" and "promoter" as those terms are defined under
the Securities Act of 1933 as amended.
All directors hold office until the next annual meeting of shareholders or until
their successors are elected. Executive Officers hold office at the discretion
of the Board of Directors.
Mr. Sealfon co-founded Repro-Med Systems, Inc. in 1980. He is an electrical
engineer and inventor and has been granted numerous United States patents. Mr.
Sealfon is a graduate of Lafayette College.
Dr. Baker earned a medical degree from Cornell University Medical College. He is
a practicing pediatrician and is attending at Department of Pediatrics Horton
Memorial Hospital, Middletown, NY and attending at New York Hospital-Cornell
Medical Center in New York City. Dr. Baker assisted us in the development of the
RES-Q-VAC Suction System. In addition, Dr. Baker has published results of use of
the RES-Q-VAC in a letter to Lancet, a medical journal.
Dr. Blumberg was a practicing urologist in the New York area, and has founded
and sold an IV business to 3M. He teaches medicine at Stony Brook University on
Long Island, and now consults for various medical companies. He makes available
a wealth of medical and business acumen to the Company.
Mr. Rosen is a principal of Kuala Medical, a public health care company which
services the nursing, home care and infusion markets. Mr. Rosen has extensive
experience in the management and operation of medical companies as well as real
estate interests.
31
Mr. Spagnoli is a principal founder and past President and Chairman of CRS,
Inc., Newburgh, NY, a manufacturer of proprietary inventory control and point of
sale software and distributor of computer equipment. Mr. Spagnoli presently
consults for CRS, Inc.
Mr. Drohan is the President and Co-Founder of Healthwave, Inc. , healthcare
technology and services company, located in Long Island, New York. He held
several positions with the North Shore Long Island Jewish Health System and has
been a Director for various health organizations.
Mr. Florman is currently employed by Empire Blue Cross Blue Shield of New York
as the Senior Vice President of Medical Delivery and Medicare Risk. He has held
various positions with Aetna US Healthcare, Inc. as well.
Item 10. Executive Compensation
Andrew I. Sealfon, President, received $129,750 in salary from Repro-Med during
the fiscal year ended February 28, 2002. Mr. Sealfon has been granted incentive
stock options in Repro-Med under its 1995 Stock Option Plan.
The officers are reimbursed for travel and other expenses incurred on behalf of
Repro-Med Systems, Inc. We do not have pension or profit sharing plans.
Summary Compensation
Name & Position Year Salary Other *
--------------- ---- ------ -------
Andrew I. Sealfon,
President 2002 $129,750 $ 6,000
2001 $129,750 $ 6,000
2000 $129,750 $ 8,949
*Other compensation includes car allowance and $6,000 for rental of lab
facilities ($2,500 was accrued at year-end).
Table of aggregated options exercised in the fiscal year and option
values at year-end February 2002:
Value of
Number of Unexercised
Unexercised In-the-Money
Shares Options at Options
Acquired Year-end at Year-end
On Value Exercisable / Exercisable/
Name of Individual Exercise Realized Unexercisable Unexercisable
- ------------------ -------- -------- ------------- -------------
A. I. Sealfon
Exercisable 0 0 1,500,000 $ 99,000
Unexercisable 0 0 0 $ 0
32
Item 11. Security Ownership of Certain Beneficial Owners and Management
The following table sets forth, as of February 2002, the number of
shares of Common Stock beneficially owned by each person owning more than 5% of
the outstanding shares, by each officer and director, and by all officers and
directors as a group:
Name of Principal Shareholders Number of Percent
and Identity of Group Shares Owned of Class Notes:
- --------------------- ------------ -------- ------
Andrew I. Sealfon* 10,538,750 45% 1,2,6
Dr. Paul Mark Baker 1,284,000 5% 6
Dr. Nathan Blumberg 180,000 0% 5,6
Joseph Rosen 100,000 0% 6
Remo Spagnoli 1,125,950 5% 3,4,6
Repro-Med Systems, Inc 2,275,000 10% 7
All Directors and Officers
as a Group (4 Persons) 15,503,700 66%
*Andrew I. Sealfon is deemed a "parent" and a "promoter" of Repro-Med Systems,
Inc. as those terms are defined under the Securities Act of 1933, as amended.
(1) Does not include 690,000 shares of common stock owned by members of Mr.
Sealfon's family, as to which Mr. Sealfon disclaims beneficial ownership.
(2) Under the terms of a voting agreement dated June 30, 1992, Messrs. Sealfon
and Zorgniotti agreed to vote their shares jointly when voting as stockholders.
This agreement which is in effect for 10 years represents 3,571,500 shares
previously owned by the Estate of A. Zorgniotti. In 1996, 2,000,000 shares were
purchased by Repro-Med Systems, Inc., January 1997, 1,571,500 were purchased in
a private transaction by a number of individual investors including at that time
an officer and three directors of Repro-Med. This same group purchased 400,000
shares from the estate of A. Zorgniotti in May 1998. These transactions were
subject to the voting agreement and results in 3,971,500 shares being classified
as owned by Mr. Sealfon.
(3) Includes 477,000 shares of Common Stock owned by six members of Mr.
Spagnoli's family.
(4) Mr. Spagnoli directly owns 10,000 shares of Repro-Med Convertible 8%
Preferred Stock. In fiscal 2002, Mr. Spagnoli received $8,000 in preferred stock
dividends and an additional $4,000 has been accrued on the balance sheet. The
preferred stock can be redeemed for 294,117 shares of Repro-Med common stock at
$0.38 per share. Consequently, 294,117 shares are deemed beneficially owned by
Mr. Spagnoli and included above.
(5) Dr. Blumberg was issued 50,000 shares through an agreement between Princeton
Research and Repro-Med Systems, Inc., which called for a total issue of 250,000
shares of stock in exchange for services rendered.
33
(6) On March 1, 1995, the Board of Directors approved two incentive stock option
programs for the benefit of key employees, directors, and officers of Repro-Med
Systems, Inc. The two plans, termed the 1995 Stock Option Plan and the 1995
Stock Option Plan For Non-Employee Directors (the "Option Plans"), provide
options to purchase 5,000,000 and 500,000 shares, respectively, of Repro-Med
common stock. We have filed a Registration Statement with the Securities and
Exchange Commission for the Option Plans. The Option Plans expire March 1, 2005.
Options granted under the 1995 Stock Option Plan to full time employees and are
intended as "incentive stock options" within the meaning of Section 422A of the
Internal Revenue Code. On March 1, 1995, the Board of Directors granted options
for 3,800,000 shares. On August 28, 1998 the option price was reduced from $.15
to $.06 per share. The option price of $.06 per share was not less than the fair
market value of the common stock on the date the price was reduced. The option
price of $.066 cents per share was not less than 110% of the fair market value
of the common stock on the date the price was reduced. As of May 2002, the only
options exercised under the plan were 200,000 options for Marion Howarth.
(exercised May 2000). 100,000 options are awarded to each Director upon signing
on as a Director. 30,000 options were issued to Dr. Blumberg, Dr. Baker and Ray
Spagnoli for their efforts during the fiscal year ended February 28,2001.
(7) Treasury stock acquired by Repro-Med Systems, Inc. total cost as reflected
on balance sheet for 2,275,000 shares of Common Stock is $142,000.
No. Shares & Earliest
Name Main Position Price Per Share Date of Exercise
- ---- ------------- --------------- ----------------
Sealfon, A. President $0.066 1,500,000, 3/1/95
Baker, M. Clinical Consultant $0.060 300,000, 3/1/95
$0.250 30,000, 5/9/01
1995 Stock Option Plan for Non-Employee Directors:
Spagnoli, R. Director $0.060 20,000, 3/1/96
20,000, 3/1/97
20,000, 3/1/98
20,000, 3/1/99
20,000, 3/1/00
$0.250 30,000, 5/9/01
Blumberg N Director $0.230 20,000, 8/1/01
20,000, 8/1/02
20,000, 8/1/03
20,000, 8/1/04
20,000, 8/1/05
$0.250 30,000 5/9/01
Rosen J. Director $0.180 20,000, 5/9/02
20,000, 5/9/03
20,000, 5/9/04
20,000, 5/9/05
20,000, 5/9/06
The above calculations give effect to purchase of shares exercisable under the
terms of the Option Plans on these issued options by each officer and director,
and by all officers and directors as a group.
34
Item 12. Certain Relationships and Related Transactions
To reduce corporate travel expenses, we maintain and operate a corporate
aircraft. Since 1992, the aircraft has been leased from AMI Aviation. Mr.
Sealfon is a majority shareholder in AMI Aviation. The lease expenses paid in
2002 were $21,500 versus $20,0500 paid in 2001. We believe the AMI lease is on
terms competitive with those that could be obtained from unaffiliated third
parties. As of February 28,2002, the Company owes AMI Aviation approximately
$3,000 for repairs made to the aircraft during the year (in accordance with the
lease agreement).
During 2002, the Company borrowed $69,000 from the President, Andrew Sealfon,
under a demand loan with an annual interest rate of 8%. The note has been
approved by the Board of Director's.
Messrs. Sealfon and Zorgniotti entered into a ten year voting agreement June 30,
1992 pursuant to which they agreed on their behalf and on behalf of their
successors in interest to vote all the shares over which they then had voting
control when voting for the election of directors (or as directors when filling
vacancies in the board) for persons designated jointly by them with one half or
a majority (if there are an odd number of directors) of the designees to be
named by Mr. Sealfon and the remainder by Dr. Zorgniotti. The voting agreement
further provides for either of them to designate all directors or to determine
how all of the shares shall be voted on other matters requiring the approval of
stockholders, in the event of the death of the other. Dr. Zorgniotti died July
7, 1994; therefore Mr. Sealfon has the exclusive right to vote all the shares
covered under the voting agreement.
PART IV
Item 13. Exhibits and Reports on Form 8-K
(a) Exhibits
(3) Articles of Incorporation and By-Laws:
3(a) Articles of Incorporation(1)
3(b) By-Laws(2)
(10) Material Contracts:
10(c) Voting Agreement for Repro-Med Systems, Inc. Common Stock
between Andrew I. Sealfon and Dr. Adrian Zorgniotti(3)
10(e) 1995 Stock Option Plan(5)
10(f) 1995 Stock Option Plan for Non-Employee Directors(5)
10(h) Sales Representative Agreement(7)
10(i) Termination Agreement(7)
(21) Subsidiary of Registrant:
NONE
35
(b) Reports on Form 8-K:
No reports on Form 8-K have been filed by the Registrant during the
last fiscal year the period covered by this report.
- ----------
(1) Incorporated by reference from the Registration and Offering Statement
of Repro-Med Systems, Inc., dated November 12, 1982.
(2) Incorporated by reference from the Form 10-KSB Report of Repro-Med
Systems, Inc., dated February 28, 1987.
(3) Incorporated by reference from Form 10-KSB Report of Repro-Med Systems,
Inc., dated February 29, 1993.
(5) Incorporated by reference from Form 10-KSB Report of Repro-Med Systems,
Inc., dated February 28, 1995.
(6) Incorporated by reference from Form 10-QSB Report of Repro-Med Systems,
Inc., dated November 30, 1998.
36
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.
REPRO-MED SYSTEMS, INC.
/s/ Andrew I. Sealfon
Andrew I. Sealfon, President
Dated: June 12, 2002
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.
/s/ Andrew I. Sealfon June 12, 2002
- --------------------------------
Andrew I. Sealfon, President,
Treasurer, Chairman of the Board,
Director, and Chief Executive
Officer, Chief Financial Officer
/s/ Dr. Nathan Blumberg June 12, 2002
- --------------------------------
Dr. Nathan Blumberg, Director
/s/ Dr. Paul Mark Baker June 12, 2002
- --------------------------------
Dr. Paul Mark Baker, Director
/s/ Remo Spagnoli June 12, 2002
- -------------------------------
Remo Spagnoli, Director
/s/ Joseph Rosen June 12, 2002
- -------------------------------
Joseph Rosen, Director
37