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SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-K
Annual Report Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
For the Fiscal Year Ended 12/31/01 Commission File Number 0-10822
BICO, Inc.
(Exact name of registrant as specified in its charter)
Pennsylvania 25-1229323
(State or other jurisdiction of (I.R.S. Employer
incorporation or organization) Identification Number)
2275 Swallow Hill Road, Bldg. 2500, Pittsburgh, Pennsylvania 15220
(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code (412) 429-0673
Securities registered pursuant to Section 12(b) of the Act: None
Securities registered pursuant to Section 12(g) of the Act:
Common Stock, $.10 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
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 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 aggregate market value of the voting stock held by
nonaffiliates of the registrant as of March 28, 2002:
Common Stock, $.10 par value --$48,943,248
As of December 31, 2001, 2,450,631,111 shares of common stock,
par value $.10 per share, were outstanding.
As of December 31, 2001, 16,930 shares of preferred stock, par
value $10 per share, were outstanding.
Exhibit index is located on pages 41 to 43
Item 1. Business
General Development of Business
BICO, Inc. was incorporated in the Commonwealth of
Pennsylvania in 1972 as Coratomic, Inc. Our manufacturing,
research & development operations are located at 625 Kolter Drive
in Indiana, Pennsylvania, 15701, and our administrative offices
are located at 2275 Swallow Hill Road, Pittsburgh, Pennsylvania,
15220.
Our primary business is the development of new devices and
technologies, which include environmental products, which help to
clean up oil spills, procedures relating to the use of regional
extracorporeal hyperthermia in the treatment of cancer, and
models of a noninvasive glucose sensor. Regional extracorporeal
hyperthermia is a system that circulates fluid in a specific area
of the body after the fluid has been heated outside the body.
The circulated fluid's higher temperature helps treat certain
diseases by inducing an artificial fever that kills targeted
cells. Our noninvasive glucose sensor helps diabetics measure
their glucose without pricking their fingers or having to draw
blood.
We have several subsidiaries that specialize in those
different projects. Petrol Rem, Inc. handles our environmental
products PRP, BIOSOK and BIOBOOM that help clean up oil
spills and other pollutants in water. ViaCirq, Inc. handles the
hyperthermia project, a technology called the ThermoChem System.
Diasense, Inc. manages the noninvasive glucose sensor project.
Our Biocontrol Technology division focuses on our biomedical
projects and on contract research and manufacturing.
Forward-Looking Statements
From time to time, we may publish forward-looking statements
relating to such matters as anticipated financial performance,
business prospects, technological developments, new products,
research and development activities, the regulatory approval
process, specifically in connection with the FDA marketing
approval process, and similar matters. You need to know that a
variety of factors could cause our actual results to differ
materially from the anticipated results or other expectations we
expressed in our forward-looking statements. The risks and
uncertainties that may affect our operations, performance,
research and development and results include the following:
additional delays in the research, development and FDA marketing
approval of the noninvasive glucose sensor; delays in the
manufacture or marketing of our other products and medical
devices; our future capital needs and the uncertainty of
additional funding; competition and the risk that the noninvasive
glucose sensor or our other products may become obsolete; our
continued operating losses, negative net worth and uncertainty of
future profitability; potential conflicts of interest; the status
and risk to our patents, trademarks and licenses; the uncertainty
of third-party payor reimbursement for the sensor and other
medical devices and the general uncertainty of the health care
industry; our limited sales, marketing and manufacturing
experience; the amount of time or funds required to complete or
continue any of our various products or projects; the attraction
and retention of key employees; the risk of product liability;
the uncertain outcome and consequences of the lawsuits pending
against us; our ability to maintain a trading market for our
common stock; and the dilution of our common stock.
Description of Business
Petrol Rem's Environmental Projects
BIOREMEDIATION AND OIL SPILL CLEAN UP
We are involved in the field of biological remediation, or
bioremediation, development. Bioremediation technology uses
naturally occurring microorganisms or bacteria to convert various
types of contamination, like oil spills, to carbon dioxide and
water. The product, PRPr, which stands for Petroleum Remediation
Product, is designed as an environmental microbial microcapsule,
which is used to collect, contain and separate oil-type products
in or from water. The product's purpose is to convert the
contaminant, with no leftover residue in need of disposal. When
the PRPr comes in contact with the petroleum substances like oil
spills, the oil spills become bound or attached to the PRPr, and
they stay afloat. Because the product contains the necessary
nutrients and microorganisms, the bioremediation process begins
immediately, which limits secondary contamination of the air or
surrounding wildlife. Eventually, the product will break down
both the petroleum and itself, leaving nothing but carbon dioxide
and water.
In 2001, Petrol Rem filed a new patent application for PRP and
its manufacture without the addition of microorganisms.
Scientific experimentation and current literature indicate that
bioremediation occurs at the same efficient level without the
added microorganisms, allowing us to cut manufacturing costs
without sacrificing performance. The patent is currently
pending.
In late 2000, Petrol Rem acquired 51% of INTCO, a Louisiana
company that specializes in regional oil spill clean-ups,
primarily on the Gulf coast of southeast Louisiana, for an
investment of approximately $1.25 million, all of which was paid
during 2001. INTCO has been using Petrol Rem's oil spill clean-up
products in clean up projects. INTCO was generating income when
we acquired our interest in 2000, and its revenues have helped
Petrol Rem's revenue flow.
During 2001, Petrol Rem focused on the Asian market. In 2000,
Petrol Rem hired a vice president of Asian sales and marketing
who speaks four languages fluently, including English. His
efforts helped increase the number of Asian distributors, which
resulted in increased sales.
Petrol Rem's revenues increased significantly during 2001, due
primarily to INTCO's revenues. Petrol Rem's total revenues for
2001 were approximately $3.384 million. Of that, approximately
$3.2 million was from INTCO and $108,000 was from bioremediation
products.
In December 2001, Petrol Rem signed a two-year agreement with
Belgian-based Clean World Solutions. The agreement grants Clean
World exclusive master distributorship rights to all of Petrol
Rem's oil spill absorption and bioremediation products throughout
Europe. Clean World placed its initial order, for $110,000, in
January 2002.
Clean World plans to grant sub-distributor agreements in each
country covered by the agreement. They have already signed
agreements with companies in Germany, Belgium and Luxemburg. For
more information on Clean World Solutions, you should visit their
website at www.cleanworldsolutions.com.
Clean World Solutions will operate the agreement through its
recently-formed division called Petrol Rem Europe. Petrol Rem
Europe officially launched its sales and marketing efforts for
the Bio-Sok at a German boat show held January 9-14, 2002 in
Dusseldorf. The European product launch for PRP took place at
the International Maritime Organization's Third Research and
Development Forum on High-density Oil Spill Response, was held in
Brest, France in mid-March 2002.
Petrol Rem received a distribution agreement for approximately
$125,000 per year from Alaskan oil spill clean-up company called
F.R.O.G. to distribute Petrol Rem products. The contract has an
initial term of one year, with automatic renewals on a yearly
basis. Due to the September 11th tragedy, the Alaskan company
was initially focused on other matters, and they placed their
first order in November 2001. Due to the extreme winter weather
in Alaska, we expect additional orders to begin in the late
spring.
In March 2002, we announced that Petrol Rem had named Winner
Advertising of Sharon, PA as its agency of record to assist with
its marketing, brand management, advertising, public and media
relations. Petrol Rem is marketing PRPr through trade shows,
magazines, direct mail advertising, and direct contacts with
companies and consultants specializing in petroleum clean-up, as
well as marketing directly to municipalities and corporations
with needs for the product. Petrol Rem also has an international
market, with its primary customers in Indonesia and Europe.
In March 2002, we announced that Corpfin.com, an Atlanta company,
has agreed to undertake the process of taking Petrol Rem from a
private company to a public company. Since the process is just
beginning, we don't know how long the process might take, or what
the terms of the transaction might be.
Part of Petrol Rem's initial research and development involved
field-testing supervised by the National Environmental Technology
Applications Corporation. That group, which is known as NETAC, is
endorsed by the Environmental Protection Agency to determine
whether products are effective. As a result of their testing,
NETAC reported positive results regarding the effectiveness of
the product.
The product is listed on the EPA's National Contingency Plan
Product Schedule, and is available in free-flowing powder or
absorbent socks. In 1995, the EPA required that all products
previously listed on the National Contingency Plan Product
Schedule be submitted to additional testing. Because PRPr
successfully passed the test conducted by NETAC, the product was
requalified for listing on the EPA's product schedule. In
addition, PRP was one of only fourteen products listed after the
1996 Alternative Response Tool Evaluation System was implemented.
In April 1993, Petrol Rem entered into a lease for a facility in
the Pittsburgh, Pennsylvania area, which is used to manufacture
PRPr. The current lease has a renewable three-year term, with
monthly rental payments of $4,661 plus utilities and applicable
business privilege taxes. Petrol Rem purchased equipment, which
has the capability to produce PRPr in quantities of 2,000 pounds
per day, and has built an adequate inventory.
Petrol Rem also completed development of a new spray applicator
for its PRP product. The new applicator is a lightweight,
portable unit, which provides a more continuous flow of product.
The lighter weight and smaller size will allow easier access to
remote sites, which were impossible to reach with the previous
applicator.
In addition to PRP, Petrol Rem also developed other products.
In order to address water pollution issues at marinas, Petrol Rem
introduced the BIOSOK, which is PRP contained in a 10" fabric
tube, and is designed and used to aid in the cleaning of boat
bilges. Bilges are commonly cleaned out with detergents and
other chemicals, which cause the oil pumped out of the bilge to
sink to the bottom of the water, where it is harmful to marine
life, and becomes difficult to collect. In addition, it is
illegal to dump oil or fuel into the water. The BIOSOK, when
placed in the bilge, absorbs and biodegrades the oil or fuel on
contact, which significantly reduces or eliminates the pollution;
then the product biodegrades itself. As a result, BIOSOK helps
to keep waters clean. In addition, BIOSOK helps eliminate the
chore of bilge cleanup, and helps users such as boaters and
marinas to avoid fines for pumping oil and fuel into the
waterways, which is prohibited. The U.S. Coast Guard is using
the BIOSOK in certain regions on their vessels and maintains a
sufficient supply to provide continuing availability.
Petrol Rem's BIOBOOM product is used in water clean-up
projects. The product is a 3" x 10' fabric tube which is filled
with PRPr, and is used to both contain and biodegrade
contaminants in water. BIOBOOM is a superior product to most
containment products because, in addition to containing the oil
or fuel spill, or restricting the spread of an anticipated spill,
it also biodegrades the contaminant, and then biodegrades itself.
These features act to virtually eliminate secondary contaminants,
thereby reducing disposal and clean-up costs.
Petrol Rem markets the BIOSOK and BIOBOOM at wholesale prices
ranging from $11-$13, and $110-$130, respectively, depending on
the quantity purchased.
We believe that we have spent all of the funds necessary to
complete the development of its bioremediation products, and to
build up sufficient inventory pending additional orders. We
expect that our expenses going forward will be for marketing and
sales. We spent approximately $17.8 million on this project
through December 31, 2001. We have been funding this project
since 1992 with money we raised by selling our securities,
including our stock or convertible debentures.
TIRE PILE CLEANUP AND OTHER PROJECTS
In 2000, Petrol Rem formed a joint venture called Tireless, LLC,
which was formed to handle the environmental and business
concerns arising from scrap and discarded tires. In 2001,
Tireless obtained a portable tire shredder, which allows Tireless
to go directly to the tire pile sites to coordinate shredding and
recycling. In September 2001, Tireless received a sub-contract
to remediate discarded tires at one of the nation's largest tire
piles near Upper Sandusky, Ohio. Tireless is now shredding tires
at that site, and we began billing during the third quarter of
2001. We believe the Tireless sub-contract could generate
revenue of at least $500,000 over the next year based on our
equipment's capacity to shred tires over the one-year period of
the contract.
During 2001, through our subsidiary Petrol Rem, we've also loaned
money to Practical Environmental Solutions, Inc., a Pennsylvania
company that acquired technology used to safely convert municipal
sludge to recyclables that comply with state and federal
environmental laws. Petrol Rem has loaned a total of $3.1
million to Practical Environmental as of December 31, 2001.
Practical Environmental has made interest payments on the amount
due. The loan, which was originally due on August 31, 2001 has
been extended until May 31, 2002; no principal payments have been
made to date. Our management is considering whether to convert
all or part of that loan to an equity investment - they are
making that decision because Practical Environmental is willing
to make that conversion and because Practical Environmental has
been generating revenues since January 2001. As of December 31,
2001, Practical Environmental's internal financial information
shows revenues of $537,100; they are still operating at a loss.
We don't currently intend to make any additional loans or
investments in Practical Environmental, except for the possible
conversion of the existing loan to equity.
ViaCirq's Extracorporeal Hyperthermia Project
CURRENT STATUS OF THE VIACIRQ PROJECT
Our subsidiary, ViaCirq, is the developer and marketer of the
ThermoChem HT System, which received FDA clearance to market in
January 2000. The ThermoChem HT System is used to deliver
intraperitoneal hyperthermia, known as IPH. Intraperitoneal
means within the abdominal cavity. Hyperthermia involves using
heat to raise temperatures. Surgeons use intraperitoneal
hyperthermia in conjunction with cytoreductive surgery - surgical
removal of cancer - and chemotherapy to treat advanced stages of
gastric cancer, colorectal cancer, appendiceal cancer, ovarian
cancer and other cancer that has spread to the lining of the
abdominal cavity.
Medical studies indicate that cancer that has spread to the
lining of the abdominal cavity is often accompanied by malignant
ascites - when cancer spreads in non-segregated tumor form, bowel
obstruction, pain, poor survival and poor quality of life.
Surgery alone may not permit the complete removal of the tumor
and microscopic residual disease often remains when the surgery
is finished. Intravenous chemotherapy can be diluted by the time
it reaches the tumors in the abdominal cavity; thus leaving the
remaining cancer unaffected. As a result, the cancer often
persists despite surgery and IV chemotherapy, resulting in
patients having few if any options.
A procedure, pioneered at Wake Forest University School of
Medicine, combines cytoreductive surgery, chemotherapy and
intraperitoneal hyperthermia to yield positive survival and
quality of life outcomes for patients with these advanced cancers
that have spread to the lining of the abdominal cavity. These
results have been published in numerous medical journals
including, The American Surgeon and The European Journal of
Surgical Oncology.
In a surgical procedure, 2 incoming catheters with temperature
probes are placed in the upper abdomen and 2 outgoing catheters
with temperature probes are placed in the lower abdominal cavity
in the pelvic area; then the abdominal cavity is temporarily
closed. The ThermoChem HT System is primed and begins
circulating 3 liters of heated sterile solution through the 2
ingoing catheters, throughout the abdominal cavity with the
heated sterile solution returning to the ThermoChem through the 2
outgoing catheters that are placed in the lower abdominal cavity
in the pelvic area. The continuous circulation of heated sterile
solution raises the core temperature of the abdomen, to the
desired temperature of the surgeon, in the range of 41 C (105.8
F) to 42 C (107.6 F). This procedure is known as intraperitoneal
hyperthermia, or IPH.
Before intraperitoneal hyperthermia is used on a patient in a
surgical procedure, the surgeon makes a midline abdominal
incision to expose the entire abdominal cavity. Tumors within
the abdominal cavity are surgically removed to the extent
possible. Ingoing and outgoing catheters are placed and the
patient's abdominal cavity is temporarily closed. The ThermoChem
HT System administers intraperitoneal hyperthermia. When the
desired core temperature, as directed by the surgeon, of the
abdominal cavity is reached, at the surgeons choice, chemotherapy
may be administered to the abdominal cavity during the procedure.
After 2 hours of intraperitoneal hyperthermia, the sterile
solution is circulated out of the abdominal cavity and the
catheters are removed. The surgical procedure is completed and
the patient is transferred to the Intensive Care Unit.
The commercial availability of the ThermoChem HT System can now
provide the broader adoption of this combined treatment within
the surgical oncology community.
During 2000, we focused on forming a Quality Control System and
geared-up for manufacturing and marketing of the ThermoChem HT
System. We entered into long-term use agreements with Wake Forest
University Medical Center in Winston-Salem, NC and Zale Lipshy
University Hospital at Southwestern Medical Center in Dallas,
Texas.
During 2001, our management team recruited a sales force and
focused on marketing the ThermoChem HT System. In March 2001, we
introduced our technology at the annual cancer symposium meeting
of The Society of Surgical Oncology in Washington, DC. In 2001,
we entered into long-term use agreements with The University of
Pittsburgh Medical Center in Pittsburgh, PA; Baylor University
Medical Center in Dallas, TX; and Sharp Memorial Hospital in San
Diego, CA to use the ThermoChem HT System to administer
intraperitoneal hyperthermia as part of their surgical oncology
program. We have entered into evaluation agreements in which the
Company is paid on a per IPH procedure to evaluate the program.
These institutions include; Veterans Affairs Medical Center in
Pittsburgh, PA; Veterans Affairs Medical Center in Cincinnati,
OH; Greenville Memorial Hospital in Greenville, SC; St. Agnes
Healthcare in Baltimore, MD; Dekalb Medical Center in Atlanta,
GA; Kettering Medical Center in Dayton, OH; the University of
Washington Medical Center in Seattle, WA; and the University of
Maryland Medical Center in Baltimore, MD.
In 2001, the Company sponsored the first and only long-term
quality of life study with Wake Forest University Baptist Medical
Center involving patients who have survived greater than three
years following intraperitoneal hyperthermia in conjunction with
cytoreductive surgery and chemotherapy.
The results of this long-term quality of life study were
presented at the 55th annual Society of Surgical Oncology
symposium in March of 2002.
In 2001, ViaCirq's board of directors, along with their
stockholders, including BICO, decided to split whole body
hyperthermia utilizing the ThermoChem System and regional
hyperthermia utilizing the ThermoChem HT System into two separate
companies. ViaCirq will continue to develop, market and sell the
ThermoChem HT System for regional hyperthermia treatments such as
intraperitoneal hyperthermia. The ThermoChem HT System can be
used for other regional hyperthermia treatments, which will
require FDA approval, such as the chest cavity perfusion,
isolated lung perfusion, isolated limb perfusion and liver
perfusion.
The newly created ViaTherm, Inc., will focus on the development
of the ThermoChem System for whole body hyperthermia for
metastatic lung cancer and HIV.
Although we had hoped to enter into an agreement with a hospital
group in China, the tragic events of September 11, 2001 and their
impact on international travel, trade and communications made
such an arrangement impossible at this time.
HISTORY AND DEVELOPMENT OF THE THERMOCHEM AND THERMOCHEM HT
SYSTEMS
ViaCirq was incorporated on October 23, 1992 as IDT, Inc.
ViaCirq focused on the research and development of the ThermoChem
System and associated disposables as a delivery system for
perfusion induced systemic hyperthermia - known as PISH - a form
of whole body hyperthermia, in the treatment of certain types of
cancers and HIV/AIDS. Perfusion induced systemic hyperthermia is
the elevation of the body's core temperature, which is like
inducing an artificial fever. Perfusion induced systemic
hyperthermia uses a device connected to incoming and outgoing
outlet catheters in the body to circulate blood outside the body
through a heat exchanger that heats the circulating blood. This
continuously circulating heated blood in and out of the body
raises the core body temperature inducing the artificial fever.
In 1993, ViaCirq formed an alliance with HemoCleanse, Inc.
located in Lafayette, Indiana. HemoCleanse, Inc., founded in
1989, designs, manufacturers and markets medical devices and
disposables for the treatment of blood outside the body.
HemoCleanse's core product was the BioLogic System, which
consists of a sophisticated, computer controlled multi-treatment
device and a series of single-use disposable treatment kits.
HemoCleanse's unique technology is based on special chemical
sorbents that selectively remove toxins from the blood while
balancing critical blood chemistries. The BioLogic System
received clearance by the FDA in 1994 as a detoxifier for
treatment of drug overdose; in 1996 the BioLogic System received
FDA clearance for use in treating patients with liver failure.
We believed that HemoCleanse's core technology was essential in
developing a safe delivery system for whole body hyperthermia.
In 1993, we entered into a license agreement with HemoCleanse to
develop the ThermoChem technology for delivering extracorporeal
hyperthermia. Under the license agreement, we received worldwide
rights to market the ThermoChem technology and disposables while
HemoCleanse retained worldwide manufacturing rights for
ThermoChem technology and disposables. We funded HemoCleanse's
development of a prototype of the ThermoChem System for PISH.
The prototype was used in preclinical trials and subsequently in
the first ever FDA approved clinical trials for AIDS and non-
small cell lung cancer (NSCLC).
The ThermoChem System consists of two components: ThermoChem HT
System and ThermoChem SB System that are necessary for delivering
PISH, a form of whole body hyperthermia.
ThermoChem HT System is fully integrated system that heats,
circulates and maintains desired blood/fluid temperatures in
delivery of whole body hyperthermia or regional hyperthermia.
ThermoChem SB System is used in conjunction with the ThermoChem
HT System to deliver whole body hyperthermia by balancing blood
chemistries on a real-time basis while removing toxins.
It is common knowledge that higher temperatures of the body, like
natural fevers, can serve to control infections. Using this
concept, the ThermoChem System induces an artificial fever to
107.6 F, which is whole body hyperthermia. During whole body
hyperthermia, however, blood chemistries shift potentially
causing severe organ damage and possibly death.
The ThermoChem System is a unique system that incorporates the
features of the ThermoChem HT, but also automatically balances
electrolytes and important nutrients using the chemical exchange
characteristics of the ThermoChem SB, while simultaneously
removing many small toxins. The electrolytes and nutrients flow
from the sorbent to the blood until equilibrium is reached.
Unbound toxins flow freely from the blood and bind to the
charcoal of the suspension.
There are many methods of inducing whole body hyperthermia
including radiant heat chambers, microwave heat chambers, water
blankets and PISH. Medical literature shows that PISH allows for
a more uniform heating of the body and a higher sustained body
temperature, which provides for a better lethal effect to the
cancerous tumor.
Perfusion Induced Systemic Hyperthermia Utilizing the ThermoChem
System
Perfusion induced systemic hyperthermia, known as PISH, is
achieved through extracorporeal blood heating which involves
heating the patient's blood outside the body to a maximum of
118.4 F and returning it back to the body, thus raising the
body's core temperature to the desired treatment temperature up
to a maximum of 108.4 F for 2 hours. Catheters are placed in two
venous access sites and attached to the disposable tubing of the
ThermoChem HT. Blood passes a roller pump that sends it onward
to the heat exchanger where indirect heating of the blood occurs,
raising the outside blood temperature to a maximum of 118.4 F. A
portion of the blood passes through a T-connection to the
ThermoChem SB, located between the roller pump and the heat
exchanger, where it is chemically balanced on a real-time basis
and then returned to the blood flow path before it reaches the
heat exchanger. Continually circulating blood is returned to the
patient at approximately 114.8 F, gradually raising the patient's
core body temperature to the desired temperature, which is
measured by various temperature probes throughout the body.
Physicians have known that cancer cells are sensitive to heat,
but only recently have the mechanisms of hyperthermia on cancer
cells been understood. The vascular structure in tumors
restricts blood supply so a tumor will retain heat, which
destroys cellular components essential for a tumor to exist while
certain chemotherapeutic drugs are potentiated by heat.
Beginning 1994, the safety and efficacy of perfusion induced
systemic hyperthermia utilizing the ThermoChem System was
evaluated in the following FDA approved and hospital
Institutional Review Board clinical trials:
St. Elizabeth Hospital - Lafayette, Indiana
1. Phase I trial completed under protocol entitled " Evaluation
of Whole-Body Hyperthermia Utilizing the ThermoChem Technology in
the Treatment of Kaposi's Sarcoma with AIDS." This was the first
FDA approved whole body hyperthermia study and was published in
The Journal of Acquired Immunodeficiency Syndrome and Human
Retrovirology.
2. Phase II trial completed under protocol entitled
"Extracorporeal Whole-Body Hyperthermia Treatments for HIV
Infections and AIDS" with results published in American Society
for Artificial Internal Organs (ASAIO) Journal.
University of Texas Medical Branch at Galveston
Phase I clinical trial completed in 2001 utilizing the ThermoChem
System and disposables to deliver perfusion induced systemic
hyperthermia for patients with non-small cell lung cancer. Non-
small cell lung cancer remains a major cause of cancer morbidity
and mortality in the United States and Europe.
One of the objectives of this trial was to evaluate the
ThermoChem technology for treatment of metastatic non-small cell
lung cancer with regard to patient selection, tumor response,
patient performance status, and patient survival. The follow-up
of the patients is patterned after the Southwest Oncology
protocols, which are considered state-of-the-art to follow
response of cancer to the therapy. Results of this study have
been published in Annals of Thoracic Surgery; Perfusion; and
American Society of Artificial Organs.
ThermoChem HT System is a fully integrated system that heats,
circulates and maintains desired blood/fluid temperatures in
delivery of whole body hyperthermia or regional hyperthermia. All
operating parameters of the system are monitored by a computer
and displayed and managed through an interactive video touch
screen display. The operator can access all system controls and
operations, in-put all necessary patient data, and define and
adjust treatment parameters with just a touch of the finger.
Beginning in May 1998, the safety and efficacy of intraperitoneal
hyperthermia utilizing the ThermoChem HT System was evaluated in
an FDA approved and Institutional Review Board clinical trial.
Wake Forest University School of Medicine
In May 1998, an Investigational Device Exemption, or IDE was
approved by the FDA to allow human clinical trials utilizing the
ThermoChem HT System and related disposables for IPH used an
adjunct therapy with surgery and chemotherapy.
In a surgical procedure all cancerous growths are surgically
removed from the patient's abdomen and pelvis; while all spaces
and lining surfaces are opened, the abdomen is circulated with a
heated physiologic solution circulating for a 2-hour period using
the ThermoChem HT System with.
The technique, using IPH, surgery and chemotherapy has been done
at Wake Forest University Baptist Medical Center since 1991 and
is now offered as a standard-of-care for the treatment of
advanced ovarian and gastrointestinal cancer.
ViaCirq and the surgeons at Wake Forest believe the ThermoChem HT
can possibly make IPH more efficient and standardize the
technique and educate others on the utilization of the ThermoChem
HT allowing more physicians to provide the life extending
treatment for patients with this advanced cancer.
In April 1999, a study was completed on patients with advanced
ovarian and gastrointestinal cancer utilizing the ThermoChem HT
System.
In May 2000, we entered into a Research Agreement with Wake
Forest School of Medicine using the ThermoChem HT System and
disposables to deliver intraperitoneal hyperthermia in
combination with cytoreductive surgery and chemotherapy in the
primary treatment of ovarian cancer. One of the main objectives
of the study is to determine the response to intraperitoneal
hyperthermia and chemotherapy as a combined therapy in patients
with Stage III ovarian cancer. The IPH treatment will be
repeated 6 months later during second-look surgery if the patient
has no residual disease. The study is currently ongoing.
Quality of Life Study
In 2001, we sponsored the first and only long-term quality of
life study with Wake Forest University Baptist Medical Center
involving patients who have survived greater than three years
following intraperitoneal hyperthermia in conjunction with
cytoreductive surgery and chemotherapy.
ViaCirq and the surgeons at Wake Forest believe that the
ThermoChem HT System can make the technique more effective with
better temperature monitoring and control. This procedure is
offered as a standard-of-care for treatment of patients with
advanced ovarian and gastrointestinal cancer.
Medical Advisory Board
ViaCirq has a medical and scientific advisory board that is made
up of these professionals. Advisory Board members do not receive
a fee for serving on the board, but are reimbursed for expenses
incurred. Brian Loggie, MD is under a separate consultant
agreement with ViaCirq that has been approved by the University
of Texas Southwest to help expand the use of intraperitoneal
hyperthermia with the ThermoChem HT System.
B. Loggie, M.D. Surgical Oncology; University
of Texas Southwestern
Intraperitoneal hyperthermia focus
S. Tomasovic, Ph.D. Tumor Biology; UT/M.D. Anderson
Cancer biology focus
R. Fleming, Ph.D. Pharmacology
Hematology/oncology focus
C. Steinhart, M.D., Ph.D. Internal Medicine;
Immunology; Mercy Hospital
HIV Specialty
In March 1999, ViaCirq entered into a license agreement with Wake
Forest University in which ViaCirq licensed all proprietary
developments, data and information owned by Wake Forest relating
to a method of heated perfusion of chemotherapy drug in treatment
of intraperitoneal and other cancers.
In April 1999, a study was completed at Wake Forest University
School of Medicine utilizing the ThermoChem HT System for
intraperitoneal hyperthermia in combination with surgery and
chemotherapy in patients with advanced ovarian and
gastrointestinal cancer.
In January 2000, HemoCleanse and ViaCirq received FDA clearance
to market the ThermoChem HT System and related disposables, which
are used to raise the core temperature of the abdominal cavity to
the desired temperature in the 41 C (105.8 F) to 42 C (107.6 F)
range by continuously bathing the abdominal cavity with
circulating sterile solution.
In June 2000, ViaCirq amended its license agreement with
HemoCleanse whereby HemoCleanse granted ViaCirq a limited,
exclusive worldwide, fully-paid, irrevocable, perpetual license
limited to the relevant field of use in hyperthermia to
manufacture the ThermoChem SB and SB treatment kits. All patents
and patent applications in whole body hyperthermia owned by
HemoCleanse were assigned to ViaCirq, the consideration for the
above was 1,042,253 shares of HemoCleanse common stock. Since
1994, we invested $ 2,460,065 in HemoCleanse stock. Of the
$2,460,065 invested in HemoCleanse common stock, approximately
$1,018,750 was invested in 1994; $1,310,822 in 1995; and $130,493
in 1998. These investments were considered speculative
throughout the term of the investment because HemoCleanse was
continually operating at a deficit due to its research and
development activities. Throughout those periods, HemoCleanse
incurred net losses, accumulated deficiencies in assets, and not
net tangible assets. Our management considered all HemoCleanse
funding to be research and development expenditures and did not
recognize any goodwill due to the absence of a proven technology.
Due to HemoCleanse's financial condition and the absence of a
fair market value for the HemoCleanse common stock, all amounts
invested in HemoCleanse were expensed when the investments were
made.
In August 2000, ViaCirq entered into a 3-year agreement with
North Carolina Baptist Hospitals to provide our ThermoChem HT
System and disposables to Wake Forest University Baptist Medical
Center. In November 2000, ViaCirq entered into a contract to
provide our ThermoChem HT System and disposables to Zale Lipshy
University Hospital at Southwest Medical Center.
In 2001, ViaCirq entered into entered into long-term use
agreements to provide our ThermoChem HT System to The University
of Pittsburgh Medical Center in Pittsburgh, PA; Baylor University
Medical Center in Dallas, TX; and Sharp Memorial Hospital in San
Diego, CA to use the ThermoChem HT System to administer
intraperitoneal hyperthermia as part of their surgical oncology
program. We've spent approximately $18.7 on this project through
December 31, 2001. We have been funding this project since 1992
with money we raised selling our securities, including our stock
or convertible debentures.
Rapid HIV Detection Corp.'s HIV Test Project
In 2001, we formed Rapid HIV Detection Corp. Rapid HIV
Detection Corp. was formed to market rapid HIV tests. Those rapid
HIV tests include:
InstantScreen, which is the initial test for HIV;
InstantConfirm, which is used to verify all positive
results; and
InstantDifferentiate, which indicates whether the patient
has HIV-1 or HIV-2. HIV-1 is the most common form of HIV;
HIV-2 is a less aggressive form found in some parts of the
world, including West Africa.
The InstantScreen test takes 30 seconds to produce results.
Only a few drops of blood are needed, and the blood is drawn with
a finger prick, rather than intravenously with a needle and vial
of blood. No additional material or special knowledge is needed
to administer the test, and only elementary level reading skills
are required. The test can be produced in different formats,
depending upon whether it will be used in a doctor's office,
hospital or in the field.
The InstantConfirm test takes about 8 minutes to perform and
is the first rapid HIV test to use the Western-Blot type HIV
confirmation technology. The Western-Blot is recognized as the
gold standard of HIV confirmation. This phase of the test is
critical, since false-positive results have been a significant
historical problem with HIV testing.
The InstantDifferentiate is used if the patient tests
positive for HIV, in order to determine whether the patient is
infected with HIV-1 or HIV-2. HIV-2 is a less aggressive form of
HIV that causes AIDs after a longer period of time than HIV-1,
and is prevalent in certain parts of the world, including West
Africa.
In order to acquire the exclusive, world-wide marketing
rights to the rapid HIV tests, we entered into a marketing
agreement with GAIFAR, a German company which owned all the
rights to the tests, and Dr. Heinrich Repke, the man who
developed the tests. The marketing rights were assigned to Rapid
HIV Detection Corp - we own 75% and GAIFAR owns 25% of Rapid
HIV's common stock. GAIFAR retained the manufacturing rights for
the tests. We entered into the agreement in June 2001 and
acquired the marketing rights at that time. The initial terms of
the agreement allowed us a due diligence period of 8 weeks to
withdraw from the agreement, but in July, all the parties agreed
to extend that date until October 15, 2001. The parties also
agreed that we would need to provide a copy of a resolution
signed by our board of directors approving the contract. In
October, we completed our due diligence period and our board
provided their unanimous resolution, making the marketing
agreement fully effective, which means that we no longer have a
right to withdraw. The marketing agreement, which we filed as
an exhibit to a Form 8-K filed October 15, 2001, has a minimum
ten-year term and calls for total payments of $7,000,000 through
the 3rd quarter of 2002. When the marketing agreement became
effective in October 2001, all funds previously loaned, which
totaled $1,025,000 were applied to the total $7 million
consideration. The remaining $5,975,000 in payments are due from
October 20, 2001 through August 20, 2002. The payments include a
range of $125,000 per month for the 3 months from October-
December 2001 to $1 million per month for the 4 months from April
- - July of 2002. The original marketing agreement provided for
payments through the 2nd quarter of 2002, and we renegotiated for
a longer payment period in October 2001.
Beginning in December 2001, we did not make payments on the
marketing agreement when they were due because of our cash flow
problems. In March 2002, GAIFAR and Dr. Repke gave us notice
that we needed to make up the late payments or they would
terminate rights under the marketing agreement. We believe we
have until May 2002 to catch up on the payments in order to
maintain our marketing rights.
Our management entered into the Marketing Agreement and
invested the money because they believe that the tests are
superior, and that we would be able to sell them to generate
revenue. The tests are priced according to the quantities
purchased and the purchaser's intended use. For example,
InstantScreen tests are priced at $5 or less - we have charged a
research facility, like Walter Reed, less than $5, and charged
commercial users closer to $5, depending upon the quantity. The
InstantConfirm and InstantDifferentiate tests will probably be
sold together, and we plan to charge between $12-15 for that
package.
Based on studies conducted by various health institutions,
which are summarized in the next two bullet points, our
management believes investing in Rapid HIV is in the best
interest of our company:
In approximately 200 tests performed by the Noguchi Memorial
Institute for Medical Research in Ghana, as well as 250 samples
in an evaluation by the World Health Organization, and 150
samples evaluated by the National Institute for Virology in South
Africa, our rapid HIV test performed with 100% accuracy.
Walter Reed Army Institute of Research completed its own
evaluation of the our rapid HIV test - in nearly 600 samples, our
rapid HIV test showed perfect results - 100% sensitivity and 100%
specificity.
Our management also believes that investing in Rapid HIV was a
good use of our company's funds because they believe that our
rapid HIV tests are superior overall to other available tests,
including Determine, Oraquick and Medmira:
One significant problem with other tests is that they have
not performed as well in the field as they have in a laboratory.
Our Rapid HIV tests can be used anywhere. This enables us to
take the tests directly to the people who need it, rather than
trying to convince them to travel distances to laboratories or
hospitals.
Another significant problem with HIV testing on a massive
scale is time - only a rapid HIV test will work. The speed of
our tests allows each patient to receive results immediately,
without leaving the test site. Tests that require the patient to
leave samples and return for them later not only jeopardize
confidentiality - but those tests are also susceptible to an
alarming but common occurrence - patients who never return for
their test results.
Our test does not require refrigeration and contains
compounds that destroy the HIV cells and other infectious cells
contained in test sample. Those cells are destroyed by one of
the chemical agents included in the test solution for that
purpose - those chemical agents can only destroy the cells in the
test sample, and cannot help to cure HIV. This means our tests
can be discarded without further sterilization or the need for
toxic waste treatment.
The result of our test can be permanently attached to the
patients' file, allowing the patient to provide his HIV status at
any time.
Our tests are affordable - we plan to charge $5 or less in
most instances for the InstantScreen test.
Although our initial focus is marketing our rapid HIV tests
outside the United States, we are also pursuing FDA approval to
sell the test in the U.S. GAIFAR and Dr. Repke began the FDA
process in November 2000 and we are currently working with GAIFAR
to design the trials needed for a full submission. Our past
experience with the FDA indicates that it will not be a quick or
easy process. We began trying to obtain FDA approval for our
noninvasive glucose sensor in 1994, and we still don't have FDA
approval. We've conducted several sets of clinical trials in our
effort to obtain FDA approval for our noninvasive glucose sensor,
and the trials we began in October 2000 are continuing. We have
not received any revenue from our noninvasive glucose sensor
since 1999.
Biocontrol Technology's Research & Manufacturing Projects
In 2001, our Biocontrol Technology division increased its efforts
to obtain research and manufacturing contracts to utilize our
manufacturing facility in Indiana, PA, while we are waiting for
the clinical trials on the Diasensor to proceed. The division
received a $1.5 million manufacturing contract from the U.S.
Army, and $238,000 research contract from a private company. We
believe the U.S. Army contract will generate $1.5 million in
revenue during the first year, beginning in the 4th quarter of
2001, with additional revenue for two additional years.
Diasense's Noninvasive Glucose Sensor Project
CURRENT STATUS OF THE NONIVASIVE GLUCOSE SENSOR
In March 2002, we decided to suspend the clinical trials for our
Diasensor 2000 for several reasons. First of all, we've made
better progress on the development of our Diasensor 3000, the
next generation of our noninvasive glucose sensor, and as soon as
it is completed, we plan to conduct a new clinical trial for the
better Diasensor. As long as we can continue to fund more
development, we hope to finish the Diasensor 3000 this year. The
Diasensor 3000 is better than the 2000 because:
It can be calibrated to the patient in a few days rather
than 6-8 weeks;
It is quicker and easier - thus less expensive to
manufacture. It takes days to manufacture the 2000, and hours to
manufacture the 3000;
It is smaller than the 2000; and
It should cost the patient much less - probably about half
as much as the 2000.
Although we are not permitted to discuss the results of the
clinical trials, the data we gathered was encouraging and helped
us develop the Diasensor 3000. Another reason we decided to
suspend the trials was that we believe that, by using the
Diasensor 3000, we can use a different type of trial - one that
is quicker and less expensive, to satisfy the FDA.
Finally, our cash flow problems made it almost impossible to
continue and complete the Diasensor 2000 trials. The trials took
much longer and were much more expensive than we planned, and we
didn't have enough money to keep them going at full scale. Some
sites had already discontinued their trials because we couldn't
keep their payments current. You should read our Managements'
Discussion and Analysis section for more information on our cash
flow problems.
We don't know how much longer the FDA approval process will take.
Although suspending the trials will delay FDA approval, we
believe that the Diasensor 3000 is a better device and we hope
that the FDA approval process for the 3000 will be shorter and
less expensive than the 2000.
Although we discontinued our Diasensor 2000 trials, the following
paragraphs tell you about how they did operate during 1999-2001.
In August 1999, we hired Joslin Diabetes Center to help us with
our FDA submission. Joslin Diabetes Center designed and
conducted the clinical trials on the Diasensor 2000.
Our contract with Joslin called for Joslin's representatives to
conduct a clinical study on the effectiveness of the Diasensor
2000. The FDA approved Joslin's protocol for the clinical study
in August 2000. In the Joslin contract, we agreed to pay for the
study, and Joslin agreed to provide us with a report on the data
gathered. Joslin also has the right, subject to confidentiality
provisions, to publish the results of the clinical trials. The
Joslin contract requires us to pay fees for their services.
In February 1999 we submitted a PMA shell to the FDA for the
Diasensor. The PMA shell is part of a revised FDA procedure,
which divides submissions into modules, or parts. These modules,
which were designed to facilitate and expedite FDA review,
contain different pieces of the full PMA submission. However,
from both our own experience and by observing other module
submissions, we do not believe that the FDA intends to "approve"
the PMA one module at a time. Rather, we have had meetings with
the FDA, including the October 1999 meeting, where requirements
for the "next step" in the process have been discussed without a
specific FDA finding on prior submissions.
In May 1999, we submitted the first module, which covered
manufacturing methods and procedures for the Diasensor 2000. The
FDA asked for additional information in September 1999, and we
responded. We filed the second module in May 2000. The second
module contained information regarding electrical and mechanical
standards for the FDA's requirements on safety and effectiveness,
and a description of how our noninvasive glucose sensor will be
used by patients. Future modules will include raw data and
laboratory study methods and test results. We'll make the final
PMA submission when our clinical trials are completed, and that
submission will include human clinical results and a summary of
safety and effectiveness data.
Clinical trials began in October 2000 at Joslin Diabetes Center
in Boston. The trials were designed for a total of 200
diabetics. Trials were also conducted at eight other sites: St.
Luke's-Roosevelt Hospital Center in New York City; SUNY Health
Science Center in Syracuse, New York; Hershey Medical Center in
Hershey, Pennsylvania; Dr. David Huffman in Chattanooga,
Tennessee; New Britain General Hospital in New Britain,
Connecticut; Tulane Medical Center in New Orleans, Louisiana; and
University of North Carolina in Chapel Hill, North Carolina; and
the University of Maryland in Baltimore, Maryland.
Although our research and development team continues to have
discussions with the FDA, due to the complex, technical nature of
the information being evaluated by the FDA, it is impossible for
us to estimate how much longer the FDA approval process will
take.
FDA approval is necessary to market the Diasensor in the United
States. In 1999, we also focused additional effort on the
European market; since no material sales have occurred, we've
discontinued our European marketing efforts.
Based on contracts between BICO and Diasense, BICO has the
exclusive right to manufacture the noninvasive glucose sensor.
Diasense will pay BICO for manufacturing, and that's how BICO
will make money if we ever successfully market and sell the
noninvasive glucose sensor.
Diasense is responsible for the marketing and sales of the
noninvasive glucose sensor. Diasense plans to market the
noninvasive glucose sensor and the telemedicine program directly
to diabetics, through their doctors' orders. We may set our
prices too high, which will limit our sales, unless we can
convince health insurance companies to pay for them. Because the
health insurance industry is in a constant state of change, we
can't predict whether - when - or if - we will convince them to
pay for our noninvasive glucose sensor or the telemedicine
program. We have estimated, based on information from the
American Diabetes Association, that there are about 15.7 million
diabetics in the United States, but not all diabetics will be
suitable users of our noninvasive glucose sensor. Those diabetics
who require and benefit from frequent glucose monitoring and
whose physicians adjust their insulin dosages based on glucose
averages over time make up the potential market for our sensor,
and we can't accurately estimate the size of that market at this
time.
HISTORY AND DEVELOPMENT OF THE NONINVASIVE GLUCOSE SENSOR
Along with Diasense, we've been working to develop a noninvasive
glucose sensor for diabetics that is able to measure glucose
without having to draw blood. Most currently available glucose
monitors require the drawing of blood by means of a finger prick.
Our initial research and development with insulin pumps led to a
theory by which blood glucose levels could be detected
noninvasively by correlating points on the infrared spectrum that
are reflected by electromagnetic energy through the skin. We
studied this method in 1986 and 1987 using laboratory instruments
and working with consultants at Battelle Memorial Institute in
Columbus, Ohio. The results of the studies provided information
regarding the use of infrared light in the noninvasive
measurement of glucose. The information from the studies, along
with later additional work, led to a patent application by our
research team in 1990. A patent covering the method was granted
to our research team and assigned to Diasense in December 1991.
Diasense purchased those patent rights from us under a purchase
agreement. We filed a second patent application in December
1992, which was granted in January 1995. That second filing
contained new claims, which extended the coverage of the patent
based on additional discoveries and data obtained since the
original patent was filed. We assigned the rights to that patent
to Diasense. We developed additional concepts to improve the
capability of the instrument to recognize blood glucose, and, in
May 1993, filed corresponding patent applications. As of
November 2001, a total of 14 U.S. patents and two foreign patents
have been issued, with additional patent applications pending.
We have the right to develop and manufacture sensors based on
contracts with us.
Our research team advanced this technology base through the
development of several research prototypes, which were tested in
human clinical trials. We conducted a trial on 110 human
subjects in March 1992. In that trial, we recorded spectral,
blood and chemical data for analysis in order to develop
calibration data for the noninvasive glucose sensor. We
conducted a second trial on 40 human subjects in July 1992 that
indicated that the device did not have a satisfactory signal-to-
noise ratio to allow for sufficient accuracy to be acceptable for
patient use. Signal-to-noise ratio is determined by the
relationship of the signal, which is the glucose level, and the
noise, which are the random interferences, such as differences in
skin surfaces. We conducted other trials at several testing
sites under the guidance of the sites' Institutional Review Board
using prototypes, which addressed the signal -to-noise problem.
We designed and constructed those prototypes to simulate
production models.
On January 6, 1994, we submitted the initial 510(k) Notification
to the Food and Drug Administration for approval to market the
production model, the Diasensorr1000. A 510(k) Notification is a
type of FDA filing used to ask the FDA to approve a device for
sale in the U.S. We based the submission on data obtained from
the advanced research prototypes, since we believed that the
production model would be identical to the advanced prototypes.
In February 1996, the FDA convened a panel of advisors to make a
recommendation regarding our 510(k) Notification. The majority
of the panel members recommended that we conduct additional
testing and clinical trials of a production model prior to
marketing the Diasensor 1000. We, along with Diasense, announced
that we would remain committed to bringing the Diasensor 1000 to
diabetics, and that additional research, development and testing
would continue.
Due to continued delays in the FDA approval process, and while
continuing to work with the FDA and conduct its mandated testing,
we turned our focus to other markets for the Diasensor 1000
besides the U.S.
In 1998, we were awarded International Organization for
Standardization certification by TUV Rheinland, a German company
authorized to conduct such audits, which was contracted to
perform an audit of our quality system. We were awarded ISO
Certification to the 9001 standard, which is evidence that we
have, in place, a total quality system for the design,
development and manufacture of our products. We were also
awarded EN46001 Certification, indicating we meet European
standards for medical devices. Once the ISO 9001 certification
was approved, and a technical file was submitted and approved by
TUV Rheinland, we received approval to apply a CE mark to the
device. Much like an Underwriters Laboratory "UL" mark, the CE
mark is provided by the regulatory bodies of the European
Community, or by authorized private bodies, such as TUV
Rheinland, to indicate that the device adheres to "quality
systems" of the ISO and the European Committee for
Standardization. The CE mark permits us to sell the Diasensor in
Europe, although we have discontinued our marketing efforts in
Europe.
With regard to marketing the device within the United States, we
continued to work with the FDA to obtain approval. After
discussions with the FDA, we submitted a revised 510(k)
Notification in October 1996, which was followed by continued
discussions with the FDA. During 1997 and 1998, we continued to
meet with the FDA, and established a protocol for in-home testing
of the Diasensor 1000. Due to our cash flow problems during
1998, testing did not proceed at the pace originally anticipated,
and completion of the testing was delayed.
We continued various aspects of the Diasensor development, which
resulted in a method that will allow the patient to transmit the
readings generated by the noninvasive glucose sensor to the
patient's clinic or physician. Following an in-depth marketing
study, we determined that the machines with this capability are
more attractive to the patient, since there is the possibility of
selling a telemedicine service which includes the machine, the
patient, and his or her physician. This model of the Diasensor
has been named the Diasensor 2000 to differentiate between the
earlier models. Based on advice from the FDA, we decided it was
in our best interest to submit a PreMarket Approval Application
to the FDA, rather than continue with the 510(k) Notification
process, in order to seek FDA approval for the Diasensor 2000.
In 1999 the FDA implemented a new PMA system. Under the new
system, individual modules - or parts - of a PMA submission could
be made as they were ready. We discuss our PMA submissions in
the "Current Status of the Noninvasive Glucose Sensor" section,
which follows.
The Diasensor is a spectrophotometer, which is a machine capable
of illuminating a small area of skin on a patient's arm with
infrared light, and then making measurements from the infrared
light that is reflected back into the device. The device then
displays the measurement in a window on the top of the device for
the user to read. The Diasensor uses internal mathematical
calculations and customized software to calculate a glucose
measurement.
Since the Diasensor will be calibrated individually, each
instrument will be sold in the U.S. by prescription only and will
be calibrated in the patient's home. This feature may limit the
marketability of the Diasensor, and if the device is unable to
qualify for third-party reimbursement - which means if the health
insurance companies won't pay for it -we will have a hard time
marketing and selling the device.
Other Projects
Implantable Technology
In April 1996, we received FDA approval to market our theraPORTr
Vascular Access System. The approval was granted in response to
our 510(k) Notification filed in January 1996. The device is
made up of a reservoir, which is implanted beneath the skin in
the chest region with a catheter inserted in a vein and provides
a delivery system for patients who require continual injections.
Because such repeated injections can cause veins to shut down and
collapse, the theraPORTr offers an improved delivery system by
eliminating that trauma. If necessary to accommodate multiple
drug therapy with incompatible drugs, dual ports can be
implanted. Such devices are frequently used in cancer drug
therapy. We began selling the standard ports during the second
quarter of 1997. A second device with a low profile was
developed for pediatric use, and a 510(k) was submitted to the
FDA in November 1997 for marketing approval. In early February
1998, we submitted a supplement to the FDA in response to a
request for additional information, and the FDA granted its
approval that same month. We are currently developing a dual
port device and plan to submit another 510(k) for that device;
however, our biomedical efforts continue to be focused on the
Diasensor, so it is impossible for us to estimate when that
submission might occur.
Through our subsidiary, Coraflex Inc., we are engaged in the
development of a polyurethane heart valve, which we believe may
not have the disadvantages of the mechanical and other synthetic
valves currently being marketed. The Coraflexr valve, which
resembles the human heart's aortic valve, is made by means of a
proprietary manufacturing process. We believe that the
polyurethane we use to make our heart valve is stronger and more
resistant to fatigue compared to other valves. In vitro testing,
some of which has been performed through the Children's Hospital
of Pittsburgh, of the Coraflexr valve to date has demonstrated
that our valve has superior fatigue resistance and flow
characteristics compared to other devices. We must conduct
additional development and testing before we can submit our valve
to the FDA to begin testing it on humans. We'll need additional
funding to do that, and we don't know when, or if, and FDA
submission or testing will occur.
We also developed technology for other implantable devices, such
as hemodialysis ports, implantable insulin dispensers and
rate-adaptive pacemakers. Because we decided to focus most of
our resources on the noninvasive glucose sensor, we haven't made
any real progress on these other projects, so they are all in
very preliminary stages of development.
Diabecore Medical, Inc.
During fiscal 2000 and 2001, through Diasense, we invested in
Diabecore Medical, Inc., a Canadian company that is conducting
research and working with other research institutions to develop
a new type of insulin to treat diabetes. In preliminary studies,
this new insulin has demonstrated effectiveness in controlling
hyperglycemia without risk of severe hypoglycemia. Laboratory
tests indicate that this new insulin, when administered in large
doses, extends the duration of insulin action for improved
control of glucose levels, rather than producing hypoglycemia.
Those tests also have shown the new insulin to be 3 to 4 times
less hypoglycemic when compared to presently available insulin.
William D. Lougheed and Kusiel Perlman, M.D. are developing
Diabecore's insulin with the support of the Research Institute of
the Hospital for Sick Children in Toronto, where insulin was
discovered, and the Loyal True Blue and Orange Research Institute
in Richmond Hill, Ontario. We have invested a total of
approximately $987,500 in Diabecore, and Diasense owns
approximately 24% of Diabecore's stock. We currently have no
plans to make additional investments in Diabecore.
MicroIslet, Inc.
During fiscal 2000 and 2001, through Diasense, we also invested
in MicroIslet, Inc. MicroIslet is a California company that is
developing several diabetes research technologies with Duke
University that focus on optimizing microencapsulated islets for
transplantation. The current research involves the use of
microencapsulated pancreatic cells, which are transplanted into
diabetic animals. The initial trial on a non-human primate
continues to provide very encouraging results. The diabetic
animal achieved and maintained normal glucose readings for over
one year following the transplant. MicroIslet believes that
there are several benefits to using the microencapsulated islets
for transplants, rather than transplanting human pancreatic
cells. One benefit is the supply; the only source of human cells
is from deceased organ donors, and more than one donor is needed
for each transplant. In addition, human transplants involve a
serious course of immuno-suppression therapy so the human
recipient does not reject the transplanted cells. Dr. Emmanuel
Opara, Ph.D. is the director of islet transplantation research at
Duke University Medical Center, and he is heading up the research
team. Dr. Opara's team is replicating the testing on 3 more
primates to obtain additional data to support a planned request
to the FDA to conduct human trials. We have invested a total of
approximately $1.6 million in MicroIslet and Diasense owns
approximately 20.2% of MicroIslet's stock. We currently have no
plans to make additional investments in MicroIslet.
Metal Plating and Coating Technology
CCTI, which stands for Ceramic Coatings Technologies, Inc., is a
Florida company that developed a ceramic coating used for metal
components. CCTI then developed a product line for sharpeners
used for knives and other tools in the professional culinary
field, for sportsmen's knives and fish hooks, for professional
woodworkers and for household use. Although we've begun to
receive revenues from CCTI, which aggregated approximately
$112,091 for 2001, we have decided to sell CCTI and are in active
negotiations with a buyer.
In March 1998, we acquired an interest in a metal-plating
company, because we estimated that the product would generate
revenue and profit. We were wrong - the actual results were very
different from our original estimates. The project did not
generate any revenue during 1998 or 1999. Our early estimates
were based upon our assessment not only of the marketability of
the product, but on our ability to penetrate the metal finishing
market using the features of the product. Our actual experience
shows that it is much more difficult to exploit the existing
market, regardless of whether or not the product has superior
features. As a result, we discontinued operations and made the
appropriate adjustments to our financial statements to reduce the
value of this investment, which totaled $4.6 million - we funded
that investment through sales of our securities including our
debentures. In 2001, we reached an agreement with the people
who sold us the interest - we still owed them money from the
purchase. They agreed to restructure the total $5,450,348 due to
them and to reduce the amount to $2,887,500. As of December 31,
2001, we had made payments totaling $387,500, and issued them $2
million of our series I convertible preferred stock.
Internet Business Services
We made investments in a company called B-A-Champ.com. That
company evolved from an internet card-trading company to an
internet business service provider and became TruePoints, Inc.
TruePoints provides internet marketing retention and promotional
services for businesses. You should visit TruePoints website at
www.truepoints.com to see how TruePoints operates and the type of
promotional and customer retention programs they provide. Fred
Cooper, our CEO, owned stock in B-A-Champ but during 2001, he
gave that stock to BICO. As of December 31, 2001, we had
invested a total of $1,445,000 in the project since the beginning
of 2000.
American Inter-Metallics
During 1999, we made our initial investment in American Inter-
Metallics, Inc. AIM has its operations in Rhode Island, and is
developing a product that enhances the performance of
propellants. AIM is developing specialized equipment and a
process for producing a product, which AIM believes will increase
the burn rates of current propellant formulas. AIM believes
that, by increasing the burn rate of propellants, its product
will improve the performance of rockets and other machinery.
During 2000, AIM completed its prototype and is now testing the
equipment. We invested $525,000 in AIM during 1999, and made
additional investments of $285,000 during 2000 and $190,000 in
2001 for a total investment of $1 million, or 20% of AIM.
AIM's product is in the research and development phase; we can't
give any assurances that it will be successful or profitable.
All this information regarding our projects is in summary form,
and the status of each project is subject to constant change. We
can't assure that any of our projects will be completed or
successful.
RESEARCH AND DEVELOPMENT
We continue to be actively engaged in the research and
development of new products. Our major emphasis has been the
development of a noninvasive glucose sensor. In order to raise
funds for the research and development of new products, we sell
our stock and convertible securities.
MARKETING AND DISTRIBUTION
Petrol Rem began marketing of its bioremediation product, PRP,
in mid-1993, and is now sold in quality marine supply stores in
the coastal areas of the United States, Canada, Europe and South
East Asia.
ViaCirq received FDA approval to market its ThermoChem-HT System
and related disposables used for regional cancer treatment.
None of our current projects have generated any meaningful sales
or revenue, although INTCO is generating revenue by providing
environmental clean-up services by using our PRP products, and
Petrol Rem's sales are increasing.
PATENTS, TRADEMARKS AND LICENSES
We own patents on certain products and we file applications to
obtain patents on new inventions when practical. Additionally,
we try to obtain licenses from others when we think it's
necessary to conduct our business.
We rely on trade secret protection for our confidential and
proprietary information. Although we and our affiliates,
Diasense, ViaCirq and Petrol Rem, take all reasonable steps to
protect such information, including the use of confidentiality
agreements and similar provisions, we can't assure that others
will not independently develop substantially equivalent
proprietary information or techniques, otherwise gain access to
our trade secrets, disclose such technology, or we can
meaningfully protect its trade secrets.
Bioremediation
In 1992 and 1993, Petrol Rem applied for patents in connection
with its bioremediation product, all of which are still pending.
Petrol Rem received trademark authorization for the use of the
product names PRP, BIO-SOK, BIO-BOOM, and Oil Buster.
In 2001, Petrol Rem filed a new patent application regarding PRP
and its manufacture without the addition of microorganisms. The
patent is currently pending.
Extracorporeal Hyperthermia
In September 1992, a research team funded by us applied for a
domestic patent in connection with the use of perfusion-induced
systemic extracorporeal hyperthermia and the treatment of HIV-
positive patients; the patent has been assigned to ViaCirq. In
October 1994, ViaCirq received notification that the patent
application for its specialized method for whole-body hypothermia
has been issued.
The patent entitled "Specialized Perfusion for Whole-Body
Hyperthermia" contains seventeen claims for the hyperthermia
procedure, including the method of heating all of the blood in
the extracorporeal blood circuit to raise the patient's core
temperature to approximately 42 C. A continuation in part, which
was filed by ViaCirq and included the ThermoChem System was
allowed in July 1995 and was issued in December 1995.
In May 1999 and early 2000, ViaCirq filed provisional patents for
its use of the ThermoChem HT System and related disposables, and
for use of the device for regional hyperthermia procedures.
In June 2000, HemoCleanse assigned all patents and patent
applications to ViaCirq relating to the ThermoChem technology in
hyperthermia. One of those patents was issued in December 2000,
and another was allowed in January 2001.
In January 2000, HemoCleanse and ViaCirq received FDA approval to
market the ThermoChem HT System and related disposables, which
are used to raise the core temperature of the abdominal cavity to
the desired temperature in the 41C (105.8 F) to 42 C (107.6 F)
range by continuously bathing the abdominal cavity with
circulating sterile solution. In addition, in February 2000, the
FDA approved continued clinical trials at the University of Texas
Medical Branch using the ThermoChem technology in whole-body
hyperthermia to treat patients with certain types of end-stage
lung cancer, which was completed in 2001.
Rapid HIV
Dr. Repke and GAIFAR, who developed the tests, own the patent
rights for the Rapid HIV test technology. From an intellectual
property viewpoint, there are two parts of the Rapid HIV
technology. The first is on the detection system and the second
is on the chemical composition of the tests themselves. So far,
Dr. Repke and GAIFAR have treated the detection system as a trade
secret, and they have not filed any patent applications for it.
In December 2001, Dr. Repke and GAIFAR received notice that the
German patent had been allowed for the chemical composition of
the InstantScreen test. U.S., European and Patent Cooperative
Treaty - PCT - applications are already in process.
Noninvasive Glucose Sensor
Diasense owns a patent entitled "Non-Invasive Determination of
Glucose Concentration in Body of Patients" which covers certain
aspects of a process for measuring blood glucose levels
noninvasively. That patent was awarded to BICO's research team in
December 1991 and was sold to Diasense under a purchase agreement
dated November 18, 1991. The patent will expire, if all
maintenance fees are paid, no earlier than the year 2008. If
clinical testing or regulatory review delays marketing of a
product made under the patent, we may be able to obtain an
extension of the term of the patent. Our patent relates only to
noninvasive sensing of glucose but not to other blood
constituents. We have filed corresponding patent applications in
a number of foreign countries.
As of November 2001, a total of 14 U.S. and two foreign patents
have been issued, all of which have been assigned to Diasense,
and additional patents are pending. Corresponding patent
applications have been filed in foreign countries where we
anticipate marketing the noninvasive glucose sensor.
Our research team continues to file patent applications,
provisional patent applications, some of which are being
converted into PCTs - Patent Cooperative Treaty - that reflect
the continued research and development and additional refinements
to the noninvasive glucose sensor.
We or Diasense may file applications in the United States and
other countries, as appropriate, for additional patents directed
to other features of the noninvasive glucose sensor and related
processes.
We know that competitors currently developing non-invasive
glucose sensors own patents directed to various devices and
processes related to the non-invasive monitoring of
concentrations of glucose and other blood constituents. It is
possible that those patents may require us to alter any model of
the noninvasive glucose sensor or the underlying processes
relating to the noninvasive glucose sensor, to obtain licenses,
or to cease certain activities.
We also rely upon trade secret protection for our confidential
and proprietary information. Although we, along with Diasense,
take all reasonable steps to protect such information, including
the use of confidentiality agreements and similar provisions,
there can be no assurance that others will not independently
develop substantially equivalent proprietary information or
techniques, otherwise gain access to the our trade secrets,
disclose such technology, or that we can meaningfully protect our
trade secrets.
We have registered our trademark "Diasensor ", which is intended
for use in connection with the Diasensor models. We intend to
apply, at the appropriate time, for registrations of other
trademarks as to any future products.
Implantable Technology
During 1995, we renewed our U.S. trademark registration for the
name Coraflexr, which was originally granted in 1988. We also
obtained trademark registration for the name theraPORTr.
In October 1996, we obtained a patent for our heart valve
product.
WARRANTIES AND PRODUCT LIABILITY
Our current product liability insurance coverage is $1,000,000 in
the aggregate, and we believe that's sufficient due to our
discontinuance of sales of certain products, including our former
pacemaker line and our functional electrical stimulators, as well
as our potential exposure to liability.
SOURCE OF SUPPLY
In connection with the manufacture the noninvasive glucose sensor
and the ThermoChem System, we will be dependent upon suppliers
for some of the components required to manufacture the device.
We plan to assemble the devices, but will need to purchase
components, including some components that will be custom made
for us by certain suppliers. These components will not be
generally available, and we may become dependent upon those
suppliers, which do provide such specialized products.
If we successfully develop other new products, and receive
regulatory approvals to manufacture such products, we may become
dependent on certain suppliers for custom parts.
COMPETITION
Bioremediation
Although our bioremediation products compete with other oil-spill
clean-up products, there is no direct competition for the type of
product we produce. The EPA recently created a separate
category for its NCP listing, for enzyme additives, and PRP is
the only product listed in that category.
Noninvasive Glucose Sensor
With the rapid progress of medical technology, and in spite of
continuing research and development programs, our developmental
products are always subject to the risk of obsolescence if some
other company introduces a better product or technique. We are
aware that other research groups have developed noninvasive
glucose sensors, and that others are still in the research &
development phase, but we have limited knowledge about the actual
technology or the stage of development for most of our
competitors. We face the risk that some other group will
complete the development of their device and penetrate the market
before we do. If that happens, there is a significant chance
that even if we receive FDA approval, our sensor will not be
successful because our marketing efforts started too late. We
don't believe there is any other company currently producing or
marketing noninvasive sensors for the measurement of blood
glucose that use the same technology as we do. Competitive
success in the medical device field is dependent upon product
characteristics including performance, reliability, and design
innovations.
Our noninvasive glucose sensor will compete with existing
invasive glucose sensors. Although we believe that the features
of our noninvasive glucose sensor, particularly its convenience
and the fact that no blood samples are required, will compete
favorably with existing invasive glucose sensors, we can't assure
that it will succeed. Most currently available invasive glucose
sensors yield accuracy levels of plus or minus 25% to 30%, range
in price from $80 to $200, not including monthly costs for
disposable supplies and accessories, and are produced and
marketed by eight to ten sizable companies. Those companies
include Bayer, Inc., Boehringer Mannheim Diagnostics, and
Lifescan, an affiliate of Johnson & Johnson. In addition,
Abbott Laboratories introduced a new test in 2001 that allows
diabetics to draw blood from areas other than their fingers, such
as from their arms. Abbott's Sof-Tac test is part of their
MediSense product line.
Those companies have established marketing and sales forces, and
represent established entities in the industry. Certain
competitors, including their corporate or joint venture partners
or affiliates, currently marketing invasive glucose sensors have
substantially greater financial, technical, marketing and other
resources and expertise than we do, and may have other
competitive advantages over us, based on any one or more
competitive factors such as accuracy, convenience, features,
price or brand loyalty. Additionally, competitors marketing
existing invasive glucose sensors may from time to time improve
or refine their products, or otherwise make them more price
competitive, so as to enhance their marketing competitiveness
over our noninvasive glucose sensor. As a result, we can't make
any guarantees that our sensor will be able to compete
successfully.
We face more direct competition from other companies who are
currently researching and developing noninvasive glucose sensors.
We have very limited knowledge as to the stage of development of
these other devices; however, if another company successfully
develops a noninvasive glucose sensor, obtains FDA approval, and
reaches the market before we do, we would suffer.
During 2001, Cygnus of Redwood, California received various FDA
approvals, including for assembly and manufacturing for its
GlucoWatch Biographer system that draws glucose through the skin
through an electric current. The glucose triggers a reaction in
a disposable pad. Although Cygnus claims that its device is
noninvasive, the fact remains that, in addition to the use of
electrical charges to draw fluid through the skin, each person
must use finger prick technology to set and use the device. The
device is being sold in the U.K., and Cygnus plans to launch
their device in the U.S. in 2002. We believe that the device
does not work for everyone, especially those who perspire, and
produces side effects including skin rashes that make regular use
difficult for some patients. We were interested to learn that
the FDA panel accepted Cygnus' use of the same error grid data
analysis - a specific method for displaying data - which the FDA
rejected when we used it for our own panel review. At this
point, we can't determine what effect, if any, the GlucoWatch
Biographer will have on our marketing or sales potential, because
we don't know how successful it will be.
Among the companies investigating infrared technology to measure
blood glucose levels noninvasively is CME Telemetrix in Waterloo,
Ontario, Canada. CME is reportedly conducting tests with a
device called a GlucoNIR via funding from Motorola, Inc. that
uses one type of infrared wavelengths. CME Telemetrix recently
reported that they were working to achieve acceptable accuracy
levels before beginning human trials. OptiScan Biomedical in
Alameda, California is developing a device that uses another type
of infrared wavelengths; they are still in clinical trials and
have not yet made an FDA submission. Johnson & Johnson's LifeScan
division has an agreement with InLight Solutions, an Albuquerque
company working on a device that uses near-infrared light to
measure blood glucose. In November 2001, Johnson & Johnson also
acquired diabetes technology from Inverness Medical Technology.
Inverness is selling an electro-chemical glucose meter and is
also in the test strip business. Rio Grande Medical
Technologies of Albuquerque, New Mexico is designing a photo-
based device. We believe Rio Grande is still being funded by
Johnson & Johnson.
Other companies claim that they are designing systems that are
semi-invasive. SpectRx in Norcross, Georgia is using a laser to
create small holes in the skin without the invasive penetration
of a metal needle or lancet. SpectRx is also using the device to
do optical scans. The device, called the Accu-Chek D-Tector,
then gives a glucose reading from the fluid collected from the
holes in the skin. SpectRx has partnered with Roche Diagnostics.
In addition, SpectRx recently received additional funding from
Abbott Laboratories and a third grant from the U.S. Centers for
Disease Control to focus on research to use the device for
children and the elderly. Last year, SpectRx reported that they
had received expedited review status from the FDA for a three-
module premarket approval filing for their diabetes detection
device; and that clinical trials are underway. Cell Robotics
International, Inc. in Albuquerque, New Mexico is also using a
laser device that pierces the skin. Called the Lasette, a laser
makes a small hole in the fingertip to draw blood for glucose
testing. A continuous glucose monitoring system from MiniMed,
Inc. in Sylmar, California received FDA approval in June 1999.
The device includes a tube with a small sensor at its tip that is
inserted through the skin, sending readings via a small wire to a
sensor. A new sensor must be reinserted under the skin every two
to three days. In November 2000, MiniMed also announced that it
had started human clinical trials of a long-term implantable
glucose sensor developed by a company called MRG. In August
2001, Medtronic bought MiniMed and changed its name to Medtronic
MiniMed.
Certain organizations are also researching and developing
technologies that may regulate the use or production of insulin
or otherwise affect or cure the underlying causes of diabetes.
We are not aware of any new or anticipated technology that would
effectively render our noninvasive glucose sensor obsolete or
otherwise not marketable. However, future technological
developments or products could make our noninvasive glucose
sensor significantly less competitive or, in the case of the
discovery of a cure for diabetes, even obsolete.
GOVERNMENT REGULATIONS
Since most of our products are medical devices as defined by the
Federal Food, Drug and Cosmetic Act, as amended, they are subject
to the regulatory authority of the FDA. The FDA regulates the
testing, marketing and registration of new medical devices, in
addition to regulating manufacturing practices, labeling and
record keeping procedures. The FDA can inspect our facilities
and operations and may also audit our record keeping procedures
at any time. The FDA's Quality System Regulation specifies
various requirements for our manufacturing processes and the way
we must maintain certain records.
In 1997, Congress passed legislation that addresses the
regulation of pharmaceutical and medical devices. Although the
impact of the FDA Administration Modernization Act of 1997 was
expected to reduce the quantity of information a company must
submit for approval of devices that has not been our experience.
Bioremediation
The EPA and the Pennsylvania Department of Environmental
Resources regulate our bioremediation products. In addition,
each state in which the bioremediation products are used has its
own environmental regulations. Regional response teams
consisting of representatives from the National Oceanic and
Atmospheric Administration, the U.S. Coast Guard and the EPA
govern our oil spill clean-up products.
Extracorporeal Hyperthermia
In January 2000, HemoCleanse and ViaCirq received FDA approval to
market the ThermoChemT-HT System and related disposables, which
are used to raise the core temperature of the abdominal cavity to
the desired temperature in the 41 C (105.8 F) to 42 C (107.6 F)
range by continuously bathing the abdominal cavity with
circulating sterile solution. In addition, in February 2000, the
FDA approved continued clinical trials at the University of Texas
Medical Branch using the ThermoChem technology in whole-body
hyperthermia to treat patients with certain types of end-stage
lung cancer.
Rapid HIV
Although our initial marketing efforts with our Rapid HIV
products are focused on international markets, GAIFAR and Dr.
Repke have begun the process to obtain FDA approval. At this
time, we cannot estimate how long or how expensive that process
might be.
Noninvasive Glucose Sensor
Since our noninvasive glucose sensor is a medical device as
defined by the Federal Food, Drug and Cosmetic Act, as amended,
it is subject to the regulatory authority of the FDA. The FDA
regulates the testing, marketing and registration of new medical
devices, in addition to regulating manufacturing practices,
labeling and record keeping procedures. The FDA can inspect our
facilities and operations and may also audit our record keeping
procedures at any time. The FDA's Quality System Regulation
specifies various requirements for our manufacturing processes
and the way we must maintain certain records.
In 1997, Congress passed legislation that addresses the
regulation of pharmaceutical and medical devices. Although the
impact of the FDA Administration Modernization Act of 1997 was
expected to reduce the quantity of information a company must
submit for approval of devices that has not been our experience.
Because the FDA regulates our noninvasive glucose sensor, we have
to meet all FDA requirements before we can market and sell our
device in the United States. These requirements include clinical
testing, which must be supervised by the chosen hospitals.
During 1999, the FDA recommended we file a Pre-Market Application
and conduct an additional clinical study. We are in the process
of submitting a modular PMA, which allows us to submit parts of
the submission to the FDA over a period of time. This modular
PMA is a new method of submitting information to the FDA, and
resulted from the passage of FDA legislation in 1997. We have
submitted the first two parts of the PMA and we began our
clinical trials in October 2000, after the FDA approved our
submission that included the testing protocol. In March 2002, we
discontinued those trials in order to finish developing our
Diasensor 3000.
We don't know how long it will take for the FDA to accept our
filings or approve our device, if ever.
In June of 1998, the FDA instituted a new Quality System
Regulation that took the place of Good Manufacturing Practices.
These regulations align closely with similar guidelines required
by the European Union and have added control of the design
process as well as the manufacturing process.
There are different requirements for selling our device in
Europe. On January 14, 1998, we received certification to ISO
9001 and to EN46001 for medical devices, and on June 23, 1998, we
received the CE mark. The CE mark and the ISO certification are
provided by the regulatory bodies or other approved companies of
the European Union. The CE mark indicates that the device
adheres to quality systems guidelines. Rigorous audits were
conducted at our Indiana, Pennsylvania facility to certify that
our development and manufacturing procedures, as well as the
Diasensor 1000r itself met the international standards laid down
by Europe's medical device directive. In order to maintain our
approval to ship the device into the European Union, we must be
vigilant in our adherence to our quality system. We will also be
subject to annual audits to be sure that we continue to meet the
required standards. Although we are not currently marketing our
device in Europe, we will maintain our ISO certification status
because we believe it provides a positive message regarding our
facility and operations and in case we decide to market outside
the U.S. in the future.
Any changes in FDA or European procedures or requirements will
require corresponding changes in our obligations in order to
maintain compliance with those standards. Those changes may
result in additional delays or increased expenses. Depending on
which other countries we target, our products may also be subject
to additional foreign regulatory approval before we can sell our
devices.
HUMAN RESOURCES
As of December 31, 2001, we had 119 full-time employees who were
located primarily in either our Indiana or Pittsburgh locations.
In addition, ViaCirq had 13 employees; and Petrol Rem had 30
employees, including 17 INTCO employees, as of December 31, 2001.
We have employment contracts with some of our non-officer
employees, most of whom are scientists and engineers employed in
our research and development operations. Those contracts are
typically for terms of five years and contain confidentiality
provisions. We also employ consultants as needed; some of the
consultants are employed based on consulting contracts, which
contain confidentiality provisions.
Financial Information About Foreign and Domestic Operations and
Export Sales
Our operations are located primarily in the United States of
America. In 1994, we incorporated a majority-owned foreign
subsidiary, Diasense U.K. Limited, in order to facilitate the
opening of our office in London, England. Although we have
taken some orders from our distributor in the U.K. and have
delivered devices for patient use, we have had no material sales,
foreign or domestic, since our inception.
Item 2. Properties
Due to cash flow problems, Diasense sold its office condominium
in 1999, and they now lease the same space for administrative
offices. We, along with our subsidiaries, continue to lease a
portion of that office at a monthly rental amount of $5,175 plus
one-half of the utilities.
Prior to 1999, our research and development operations were
located in a 20,000 square foot one-story building at 300 Indian
Springs Road, Indiana, PA. We leased that building from the 300
Indian Springs Road Real Estate Partnership, which was owned in
part by some of our current and former officers and directors.
Of the eight members of the partnership, two are currently
officers or directors - Fred E. Cooper and Glenn Keeling. Each
member of the partnership personally guaranteed the payment of
lease obligations to the bank providing the funding, and in
return received warrants to buy 100,000 shares of our stock at
$.33 per share. In addition to rent, we paid all taxes,
utilities, insurance, and other expenses related to our
operations at that location. In 1999, after all our Indiana, PA
operations were moved out of 300 Indian Springs Road location to
Kolter Drive, the property was put up for sale. The property was
sold in October 2000 for $475,000, and each of the partners
received $12,698, after the mortgage was paid.
In September 1992, we entered into a ten-year lease agreement
with the Indiana County Board of Commissioners for 35,000 square
feet of space on Kolter Drive that we reconfigured to our
manufacturing specifications. During 1998 and 1999, we moved the
balance of our Indiana, Pennsylvania operations to this space.
During 2000, we obtained an additional 33,000 square feet of
manufacturing space, which is being completed for manufacturing.
That space, which was originally obtained in 1995, was vacated in
1998 in return for the lessor's agreement not to pursue legal
action against us for nonpayment of rent. In 2000, we settled
all the pending legal issues with the lessor when we reacquired
the space. This facility contains sufficient additional space to
accommodate our projected Indiana operations through 2002.
We believe that our existing facilities will be sufficient to
meet our needs through 2002. If we require additional space, we
believe such space will be available at reasonable commercial
rates.
Item 3. Legal Proceedings
In May 1996, we, along with Diasense and our current and former
individual directors, including David Purdy, Fred Cooper, and
Anthony J. Feola, who are also current and former Diasense
officers and directors, were served with a federal class action
lawsuit based on alleged misrepresentations and violations of
federal securities laws. In 2000, even though we don't believe
any violations of the securities laws occurred, we agreed to
settle the lawsuit. The parties reached a settlement, and we
have paid an aggregate of $3,250,000 toward the settlement to
date. During the 3rd quarter of 2001, the parties agreed to
extend the payments on the remaining balance. A balance of
$425,000 is due, including $225,000 for extending the due dates.
Although we don't know whether the class action plaintiffs have
been formally notified of the settlement, or if they have
accepted its terms, we believe the existing settlement agreement
will end this matter. Due to cash flow problems, we did not make
the full final payment on the settlement. We need to make an
additional payment of $425,000 in order to satisfy the terms of
the settlement.
In April 1998, we, along with our corporate affiliates, were
served with subpoenas requesting documents in connection with an
investigation by the U.S. Attorneys' office for the U.S. District
Court for the Western District of Pennsylvania. We continue to
submit various scientific, financial and contractual documents in
response to their requests.
In April 1996, the Pennsylvania Securities Commission commenced a
private investigation into sales of Diasense common stock in a
public offering in an effort to determine whether any sales were
made improperly to Pennsylvania residents. We cooperated fully
with the state and provided all of the information requested. As
of the date of this filing, no determinations had been made, and
no orders have been issued.
Item 4. Submission of Matters to a Vote of Security Holders
At a shareholders' meeting held on November 30, 2001, our
shareholders approved an increase in the number of our authorized
shares of common stock from 2.5 billion to 4 billion.
Item 5. Market for Registrant's Common Equity and Related
Stockholder Matters
Our common stock trades on the electronic bulletin board under
the symbol "BIKO". On March 18, 2002,9, the closing bid price
for the common stock was $.14.$.018. The following table sets
forth the high and low bid prices for our common stock during the
calendar periods indicated, through December 31, 2001. Because
our stock trades on the electronic bulletin board, you should
know that these stock price quotations reflect inter-dealer
prices, without retail mark-up, markdown or commission, and they
may not necessarily represent actual transactions.
Calendar Year High Low
and Quarter
1999 First Quarter $ .084 $ .049
Second Quarter $ .340 $ .048
Third Quarter $ .125 $ .070
Fourth Quarter $ .099 $ .050
2000 First Quarter $1.050 $.051
Second Quarter $.400 $.160
Third Quarter $.184 $.12
Fourth Quarter $.122 $.049
2001 First Quarter $.1355 $.05
Second Quarter $.072 $.037
Third Quarter $.057 $.01
Fourth Quarter $.049 $.02
We have approximately 135,000 holders, including those who hold
in street name, of our common stock, and 41 holders of our
preferred stock.
DESCRIPTION OF SECURITIES
Our authorized capital currently consists of 4 billion shares of
common stock, par value $.10 per share and 500,000 shares of
cumulative preferred stock, par value $10.00 per share.
Preferred Stock
Our Articles of Incorporation authorize the issuance of a
maximum of 500,000 shares of cumulative convertible preferred
stock, and authorize our board of directors to define the terms
of each series of preferred stock. In 2001 and 2002, our board
of directors authorized the creation of five new series of
convertible preferred stock - series G, H, I, J and K. The
certificates of designation for each series - the corporate
document that defines the terms of those series of preferred
stock - are exhibits to this document. As of March 29, 2002 we
had a total of 32,280 shares of our preferred stock outstanding,
as follows:
10,530 shares of Series G
2,000 shares of Series H
4,000 shares of Series I
750 shares of Series J
15,000 shares of Series K
None of our convertible preferred stock is secured by any of
our assets. Each share of our preferred stock has a designated
value of $500 per share. There is no minimum conversion price,
so the lower the bid price of our stock, the more shares we will
need to issue when our preferred stock is converted - there is no
limit on the number of shares of our common stock that our
preferred stock can be converted into. This means that, if our
stock price is low, the preferred stockholders could own a large
percentage of our outstanding common stock - except that they
have each agreed not to own more than 5% of our common stock at
any one time. We only sold our preferred stock to accredited
investors. We can redeem our preferred stock.
Each series of preferred stock has its own minimum holding
period and each series defines its conversion price.
Our series G preferred stock has a minimum holding period of
the earlier of: 60 days from issuance or the date the
registration statement covering the common stock is declared
effective by the SEC. The series G preferred is convertible into
our common stock at a 24% discount to the 5-day average of our
closing bid price immediately prior to conversion.
Our series H preferred stock has a minimum holding period of
the earlier of: 75 days from issuance or 35 days after the date
the registration statement covering the common stock is declared
effective by the SEC. The series H is convertible into our
common stock at a 20% discount to the 5-day average of our
closing bid price immediately prior to conversion.
Our Series J preferred stock has a minimum holding period of
30 days from issuance and is convertible into our common stock at
a 20% discount to the 5-day average of our closing bid price
immediately prior to conversion.
As of March 2002, we raised a total of $6,640,000 from selling
our series G, H and J preferred stock.
We issued 4,000 shares of our series I preferred stock to Mr.
and Mrs. Farrell Jones as part of a renegotiation and settlement
of amounts due in connection with our purchase of ICTI back in
1998. Even though we wrote off that entire investment, we still
owed the Joneses a total of $5,450,348. In December 2001, we
finalized an agreement with the Joneses to decrease the amount
owed to a total of $2,887,500. Of that total, $2 million was
applied when we issued them the 4,000 shares of series I
preferred stock. The series I preferred is convertible at any
time into our common stock based on the 5-day average of our
closing bid price immediately prior to conversion. None of the
series I has been converted to date. We don't have any other
relationship with the Joneses other than these remaining issues
from the ICTI transaction. You should review our management's
discussion and analysis section for more information on the
settlement with the Joneses.
In February 2002, we accepted a $25 million funding
commitment from J.P. Carey Asset Management, LLC, a Georgia
corporation. The first part of the funding is through J.P. Carey
Asset Management's purchase of $7.5 million of our Series K
preferred stock. We will not begin to receive it until our
registration statement covering the common stock underlying the
preferred is declared effective by the SEC. We agreed to register
the underlying common stock for them. We will receive money when
they convert the Series K preferred into common stock, based on the
following formula. For example, if you apply the formula to last
month, we could have received about $1.7 million. If our stock price
and/or our trading volume decrease, we would receive less.
First, compute the daily trading value for our stock: the
closing bid price times that days' volume
Second, compute that daily trading value for the 22 trading
days prior to conversion
Third, take the average of those 22 days trading value
Finally, multiply that 22-day average by 6.
The conversion price for the Series K preferred is based on a
10% discount to the average of the lowest 3 consecutive closing
bid prices during the 22 days prior to conversion. For example,
if conversion had occurred on March 18, 2002, it would have been
at a 10% discount to the average closing bid prices on March 6,
7, and 8, 2002. That price, after the discount, would be $0.0158
per share. If our stock price drops, the conversion price per
share will also drop.
Common Stock
Holders of our common stock are entitled to one vote per
share for each share held of record on all matters submitted to a
vote of stockholders. Holders of our common stock do not have
cumulative voting rights, and therefore the holders of a majority
of the shares of common stock voting for the election of
directors may elect all of the directors, and the holders of the
remaining common stock would not be able to elect any of the
directors. Subject to preferences that may be applicable to the
holders of our preferred stock, if any, the holders of our common
stock are entitled to receive dividends that may be declared by
our board of directors.
In the event of a liquidation, dissolution or winding up of
our operations, whether voluntary or involuntary, and subject to
the rights of any preferred stockholders, the holders of our
common stock would be entitled to receive, on a pro rata basis,
all of our remaining assets available for distribution to our
stockholders. The holders of our common stock have no
preemptive, redemption, conversion or subscription rights. As of
December 31, 2001, we had 2,450,631,111 shares of our common
stock outstanding.
Dividends
We have not paid cash dividends on our common stock, with the
exception of 1983, since our inception. We do not anticipate
paying any dividends at any time in the foreseeable future. We
expect to use any excess funds generated from our operations for
working capital and to continue to fund our various projects.
Our Articles of Incorporation restrict our ability to pay cash
dividends under certain circumstances. For example, our board
can only declare dividends subject to any prior right of our
preferred stockholders to receive any accrued but unpaid
dividends. In addition, our board can only declare a dividend to
our common stockholders from net assets that exceed any
liquidation preference on any outstanding preferred stock.
Employment Agreement Provisions Related to Changes in Control
We have employment agreements with change in control
provisions with the following officers: Fred E. Cooper, Anthony
J. Feola, Glenn Keeling and Michael P. Thompson. The agreements
provide that in the event of a "change of control," we must:
issue to Mr. Cooper shares of common stock equal to 5%; issue to
Mr. Feola 4%; issue to Mr. Keeling 3%; and issue to Mr. Thompson
2% each of our outstanding shares of common stock. For purposes
of these agreements, a change of control is deemed to occur: when
20% or more of our outstanding voting stock is acquired by any
person; or when 1/3 or more of our directors are not continuing
directors, as defined in the agreements; or when a controlling
influence over our management or policies is exercised by any
person or by persons acting as a group within the meaning of the
federal securities laws.
Warrants
As of December 31, 2001, we had outstanding warrants - most
of which are not currently exercisable - to purchase 96,136,560
shares of our common stock. These warrants have exercise prices
ranging from $.015 to $3.20 per share and expiration dates
through December 4, 2006, and are held by members of our
scientific advisory board, certain employees, officers,
directors, loan guarantors, and consultants. As of December 31,
2001, many of our outstanding warrants were not currently
exercisable - 82,746,898 warrants were subject to a lock-up
arrangement where the warrant holders agreed not to exercise them
until August 2002.
Holders of warrants are not entitled to vote, to receive
dividends or to exercise any of the rights of the holders of
shares of our common stock for any purpose until the warrant
holder properly exercises the warrant and pays the exercise
price.
Transfer Agent
Mellon Investor Services in New York, New York acts as our
Registrar and Transfer Agent for our common stock. We act as our
own registrar and transfer agent for our preferred stock and
warrants.
Item 6. Selected Financial Data
YEARS ENDED DECEMBER 31st
2001 2000 1999 1998 1997
Total Assets $24,637,421 $21,930,070 $15,685,836 $9,835,569 $12,981,300
Long-Term
Obligations $ 2,280,935 $ 2,211,537 $ 1,338,387 $1,412,880 $ 2,697,099
Working
Capital ($10,429,990) $ 754,368 $ 4,592,935 ($9,899,008) $ 888,082
(Deficit)
Preferred
Stock $ 169,300 $ 0 $ 720,000 $ 0 $ 0
Net Sales $ 4,342,203 $ 340,327 $ 112,354 $1,145,968 $ 1,155,907
TOTAL
REVENUES $ 4,349,918 $ 345,874 $ 165,251 $1,196,180 $ 1,260,157
Other Income $ 561,817 $ 589,529 $ 1,031,560 $ 182,033 $ 165,977
Warrant
Extensions $ 0 $ 5,233,529 $ 4,669,483 $ 0 $ 4,046,875
Benefit
(Provision)
for Income
Taxes ($ 120,882) $ 0 $ 0 $ 0 $ 0
Net Loss ($30,942,310)($42,546,303)($38,072,578)($22,402,644)($30,433,177)
Net Loss per
Common Share:
Basic ($.02) ($.04) ($.05) ($.08) ($.43)
Diluted ($.02) ($.04) ($.05) ($.08) ($.43)
Cash Dividends
per share:
Preferred $ 0 $ 0 $ 0 $ 0 $ 0
Common $ 0 $ 0 $ 0 $ 0 $ 0
Item 7. Management's Discussion and Analysis of Financial
Condition and Results of Operations
The following is a summary of the more detailed information in
our financial statements. You should carefully review those
financial statements before you decide whether to invest in our
stock.
Forward-Looking Statements
This section contains forward-looking statements. We discussed
these kinds of statements on page 2, and you should review that
section.
Liquidity and Capital Resources
We continue to be dependent on security sales as our primary
source of working capital. As of December 31, 2001, we had total
authorized common stock of 4 billion shares of which
2,450,631,111 shares were issued and outstanding. We had a
working capital deficiency at December 31, 2001 of ($10,429,990)
as compared to working capital of $754,368 at December 31, 2000
and $4,592,935 at December 31, 1999. Our working capital
fluctuates each year due to the amount of money we raise by
selling our securities and the amount of money we spend. We
raised approximately $16.4 million in 2001, $29.9 million in 2000
and $10.7 million in 1999 from selling our securities.
During the 4th quarter of 2001, we had significant cash flow
problems. We believe those problems are in large part due to the
overall economic recession, which was aggravated by the tragedies
of September 11, 2001. The stock market's resulting decline and
other factors beyond our control made it difficult for us to
raise money by selling our preferred stock. We only raised
$6.465 million in 2001, which is much less than we expected. As
a result, our payroll and our accounts payable are seriously past
due. We also have other serious obligations that are past due.
We still owe $425,000 in connection with our class action
settlement. Although we are working with the class action
counsel to make payments on the amount due, we can't assure you
how long they will continue to work with us. They could obtain
an order from the judge demanding that we pay the balance, and if
we can't, they could enter a judgment against us.
In November 2001, our stockholders approved an increase in our
authorized shares from 2.5 billion to 4 billion. Once the new
shares were approved, we began selling convertible preferred
stock in a private offering, as we have done in the past. Those
new convertible securities will not be and have not been
registered under the federal securities laws and may not be
offered or sold in the United States without registration or an
applicable exemption from registration requirements. During
November and December 2001, we issued the following shares of
convertible preferred stock:
10,530 shares of Series G
2,000 shares of Series H
4,000 shares of Series I
400 shares of Series J
None of our convertible preferred stock is secured by any of our
assets. Each share of our preferred stock has a designated value
of $500 per share. There is no minimum conversion price, so the
lower the bid price of our stock, the more shares we will need to
issue when our preferred stock is converted - there is no limit
on the number of shares of our common stock that our preferred
stock can be converted into. This means that, if our stock price
is low, the preferred stockholders could own a large percentage
of our outstanding common stock - except that they have each
agreed not to own more than 5% of our common stock at any one
time. We only sold our preferred stock to accredited investors.
We can redeem our preferred stock.
Each series of preferred stock has its own minimum holding period
and each series defines its conversion price.
Our series G preferred stock has a minimum holding period of
the earlier of: 60 days from issuance or the date the
registration statement covering the common stock is declared
effective by the SEC. The series G preferred is convertible into
our common stock at a 24% discount to the 5-day average of our
closing bid price immediately prior to conversion.
Our series H preferred stock has a minimum holding period of
the earlier of: 75 days from issuance or 35 days after the date
the registration statement covering the common stock is declared
effective by the SEC. The series H is convertible into our
common stock at a 20% discount to the 5-day average of our
closing bid price immediately prior to conversion.
Our Series J preferred stock has a minimum holding period of
30 days from issuance and is convertible into our common stock at
a 20% discount to the 5-day average of our closing bid price
immediately prior to conversion.
We raised a total of $6,465,000 from selling our series G, H
and J preferred stock in 2001.
We issued 4,000 shares of our series I preferred stock to Mr.
and Mrs. Farrell Jones as part of a renegotiation and settlement
of amounts due in connection with our purchase of ICTI back in
1998. Even though we wrote off that entire investment, we still
owed the Joneses a total of $5,450,348. In December 2001, we
finalized an agreement with the Joneses to decrease the amount
owed to a total of $2,887,500. Of that total, $2 million was
applied when we issued them the 4,000 shares of series I
preferred stock. The series I preferred is convertible at any
time into our common stock based on the 5-day average of our
closing bid price immediately prior to conversion. None of the
series I has been converted to date. We don't have any other
relationship with the Joneses other than these remaining issues
from the ICTI transaction. Note J to our financial statements
contains more detail on the transaction with the Joneses.
When we sell or issue these convertible securities, it could
cause our stock price to fall significantly, and we don't have
any control over that. Factors including the timing of
conversions and the additional number of shares needed for
conversion with no limit contribute to the downward pressure on
our stock price. In addition, although the purchasers of our
convertible preferred stock agree not to sell our stock short, if
other investors sell short, it will further contribute to the
decline of our stock price. In the past few years, we've sold
both convertible securities and common stock in various
offerings, all of which were on a best-efforts basis:
We registered 800 million shares of common stock in the
third quarter of 2001;
We registered approximately 431 million shares in the third
quarter of 2000, which included both common stock and conversion
shares for convertible preferred stock and convertible
debentures;
We registered 375 million shares of common stock in the
second quarter of 1999; and
We registered 200 million shares of common stock in the last
quarter of 1998.
Selling more of these convertible securities will further dilute
ownership of existing stockholders but, until we find another way
of raising significant funds, we must continue to sell our stock.
Our cash decreased to $268,095 as of December 31, 2001 from
$7,844,807 as of December 31, 2000 primarily due to the factors
discussed below.
During the year ended December 31, 2001 our net cash flow used by
operating activities was ($25,891,584). During the same period,
our net cash flow used by investing activities was ($5,063,413)
due primarily to the acquisition of property, plant and
equipment, additional loans made to Practical Environmental
Solutions, a company involved in the acquisition and management
of environmental entities, investments in Rapid HIV, and
additional investments in unconsolidated subsidiaries which we
discuss in the following paragraphs. We made all of these
investments because we believe that they will either generate
revenue or will help us with our diabetes-related projects.
During 2001, we made additional investments in unconsolidated
subsidiaries. We invested an additional $190,000 in American
Inter-Metallics, bringing our total investment in AIM's rocket
propulsion project to $1,000,000. In addition, we loaned
$110,000 to Anthony J. DelVicario, the president of American
Inter-Metallics, Inc. and a former member of Diasense's board of
directors to help fund a transaction involving the creation of a
distribution system in Europe to sell AIM's products which we
believe will generate revenue. The original demand note was
secured by 110,000 shares of American Inter-Metallics, Inc.
common stock and bore interest at prime rate plus two percent.
In November 2001, we converted the original note into a new note
for $114,000 to reflect accrued interest. The new note is
secured by an unconditional guaranty by American Inter-Metallics
and all of American Inter-Metallics' assets, including all of its
equipment. AIM informed us that they are in the final stage of
closing the transaction, and they expect to repay the loan; in
the interim, Mr. DelVicario began making monthly payments of
$5,000 per month in March 2002. We also increased our total
investment in Insight Data Link.com, Inc. to $110,000 by
investing an additional $10,000. We increased our investment in
AIM and Insight Data Link because our management believes they
will generate earnings. However, AIM has not yet generated any
revenue, and Insight Data Link has only generated minimal
revenues of approximately $2,000 to date. As a result, we will
not make any additional investments in either of those companies.
Our subsidiary, Diasense, Inc. also made investments in
unconsolidated subsidiaries during 2001. Diasense invested an
additional $600,000 in MicroIslet, Inc., a company working with
Duke University on several diabetes research technologies that
focus on optimizing microencapsulated islets for transplantation.
The project is in the research and development phase. As of
December 31, 2001, Diasense had invested $1,600,000 in MicroIslet
and owned approximately 20.2% of this company. Diasense also
increased its investment in Diabecore Medical, Inc. Diabecore is
a company in Toronto working with other research institutions to
develop a new insulin to treat diabetes. In 2001, Diasense
invested $293,948 in Diabecore increasing the total amount
invested to $987,468 and its ownership in this company to
approximately 24%. This project is also in the research and
development phase. Diasense increased these investments because
management believes that these diabetes research organizations
and the institutions they affiliate with will bring strength and
support to our own diabetes research and development projects.
As a result of those additional investments in American Inter-
Metallics, Insight Data Link.com, MicroIslet and Diabecore
Medical, our overall investment in unconsolidated subsidiaries
increased from $2,061,439 as of December 31, 2000 to $2,409,843
at December 31, 2001.
During the year ended December 31, 2001, our subsidiary, Petrol
Rem, advanced an additional $1,234,041 to Practical Environmental
Solutions, a Pennsylvania company that acquired technology used
to safely convert municipal sludge to recyclables that comply
with state and federal environmental laws. Petrol Rem has loaned
a total of $3,148,404 to Practical Environmental as of December
31, 2001. Practical Environmental has made interest payments on
the amount due. The loan, which was originally due on August 31,
2001 has been extended until May 31, 2002; no principal payments
have been made to date. The loan is classified as a non-current
asset as of December 31, 2001 because our management is
considering whether to convert all or part of that loan to an
equity investment - they are making that decision because
Practical Environmental is willing to make that conversion and
because Practical Environmental has been generating revenues
since January 2001. As of December 31, 2001, although they are
still operating at a loss, Practical Environmental's internal
financial information shows revenues of $537,100. We may
consider making additional loans or investments in Practical
Environmental if those loans or investments could help increase
earnings.
During the year ended December 31, 2001 Petrol Rem also invested
an additional $99,060 in Tireless LLC, which is another part of
our Petrol Rem operations, bringing our total equity investment
to $455,000. Tireless is a company that shreds and helps recycle
tires, addressing some significant environmental issues that
arise from large piles of used tires. We also loaned Tireless
$515,610 during the year ended December 31, 2001, which was used
primarily to purchase a mobile tire-shredding machine that is
being used to fulfill a contract in Ohio. As of December 31,
2001, Tireless has only generated $63,127 in revenues, and we are
re-evaluating whether to continue to invest in Tireless.
In 2001, we formed Rapid HIV Detection Corp. to market rapid HIV
tests. In order to acquire the exclusive, world-wide marketing
rights to the rapid HIV tests, we entered into a marketing
agreement with GAIFAR, a German company which owned all the
rights to the tests, and Dr. Heinrich Repke, the man who
developed the tests. The marketing rights were assigned to Rapid
HIV Detection Corp - we own 75% and GAIFAR owns 25% of Rapid
HIV's common stock. We entered into the agreement in June 2001
and acquired the marketing rights at that time. The initial
terms of the agreement allowed us a due diligence period of 8
weeks to withdraw from the agreement, but in July, all the
parties agreed to extend that date until October 15, 2001. The
marketing agreement, which we filed as an exhibit to a Form 8-K
filed October 15, 2001, has a minimum ten-year term and calls for
total payments of $7,000,000 through the 3rd quarter of 2002.
That entire $7 million was accrued as of December 31, 2001, and
the rights are reflected in intangible assets. When the
marketing agreement became effective in October 2001, $1.025
million of the funds previously loaned were applied to the total
$7 million consideration. The original agreement called for a
loan in the amount of $500,000 to the owner of the rapid HIV
tests and technology, but we agreed to loan another $125,000
during the 2nd quarter while we continued our due diligence, so
the total loans were $625,000 as of June 30, 2001. During the
3rd quarter of 2001, we loaned an additional $400,000 while we
completed our due diligence; the total loan amount applied to the
$7 million total due was $1,025,000. The loan was made part of
the consideration we paid to acquire the exclusive worldwide
marketing rights to the rapid HIV tests and technology, and is
now part of our investment in Rapid HIV. The remaining $6 million
in payments are due from October 20, 2001 through August 20,
2002. We made the $125,000 payments due in October and November
2001 and made additional payments totaling $125,000 through
January 2002. Due to our cash flow problems, we were unable to
make additional payments when they were due. As a result, we may
end up losing our exclusive marketing rights if we cannot bring
the payments due current by May 2002.
The money we spent investing in these companies came from notes
payable, debentures payable and stock sales during 2001.
In July 2001, we announced that ViaCirq entered into a Memorandum
of Understanding with Phoenix Hospital Management to pursue a
joint venture to market and sell ViaCirq products in China. In
August we announced that negotiations were continuing. The
tragic events of September 11, 2001 further delayed the travel
and communication necessary to continue meaningful work on or to
finalize the transaction. As of the date of this filing, due
primarily to the international economic and trading instability
resulting from the terrorist attacks and the military response to
those attacks, we no longer believe this transaction is feasible
and have discontinued negotiations. We may re-open negotiations
in the future, but at this point, we do not believe the joint
venture will occur.
Accounts receivable, net of allowance for doubtful accounts,
increased from $400,950 as of December 31, 2000 to $1,235,957 as
of December 31, 2001. The increase is primarily attributable to
the increase in revenues for INTCO, a consolidated subsidiary of
Petrol Rem, and the timing of billings and collections related to
these revenues. Due to our cash flow problems, we borrowed over
$500,000 from the minority owner of INTCO, our Louisiana oil-
spill clean-up company, and we secured that loan with our 51%
ownership in INTCO. If we are unable to repay that loan when the
payments are due in April and June 2002, we may lose our
ownership interest in INTCO, and with it, a major source of
revenue.
Our net inventory increased from $805,224 as of December 31, 2000
to $1,190,796 as of December 31, 2001. The increase was
primarily due to an inventory build-up for the ThermoChem
hyperthermia products and for other manufacturing projects being
completed at our Indiana, PA facility.
Current related party receivables increased by $50,688 during the
year ended December 31, 2001 due to the $114,000 loan made to
Anthony DelVicario (a former member of Diasense's board of
directors) that was previously discussed. This addition to
current related party receivables was partially offset by
repayments on other related party notes.
Acquisitions of property, plant and equipment included increases
of machinery and equipment aggregating $1,120,607 for the year
ended December 31, 2001 primarily due to additions of
hyperthermia equipment for our ViaCirq subsidiary and the
purchase of tire-shredding equipment for Petrol Rem's subsidiary,
Tireless. Leasehold improvements increased by $222,955 primarily
due to renovations made to our Indiana, PA facility.
Related party receivables decreased by $138,445 due primarily to
repayments on related party notes.
Accounts payable increased by $4,176,925 during the year ended
December 31, 2001 due to the timing of payments that were slower
than normal due to our cash flow problems. Notes payable
increased by $5,968,071 during 2001 primarily due to the
obligation incurred with the purchase of marketing rights by
Rapid HIV discussed above. Our current portion of long-term debt
decreased by $4,027,236 during 2001 due to the negotiated
settlement of amounts due in connection with debt incurred when
ICTI was purchased.
On October 11, 2001, Petrol Rem borrowed $500,000 from the
minority owner of its subsidiary, INTCO, Inc., under a promissory
note that bears interest at 7% per year and is due in April 2002.
To secure payment of the note, Petrol Rem pledged all of its
shares in INTCO, Inc. The note is secured by our 51% interest in
INTCO, and if we don't make the payments when they are due in
April and June 2002, we could lose our investment in INTCO.
Debentures payable decreased by $2,400,000 during year ended
December 31, 2001 due to the conversion of $10,655,659 of
debentures into common stock partially offset by the sale of
$8,255,659 of convertible subordinated debentures to raise
capital to fund operations. We had no debentures outstanding as
of December 31, 2001.
In July and August, we raised $11,164,000 through the sale of
common stock subscriptions. As of December 31, 2001, 769,410,092
shares of stock had been issued to satisfy $9,900,000 of these
subscriptions. In addition, the Company repurchased
subscriptions totaling $1,264,000 for $1,453,600. As a result of
the conversion of debentures and the issuance of common stock to
satisfy stock subscriptions, our common stock balance increased
to $245,063,111 as of December 31, 2001 compared to $138,370,417
as of December 31, 2000. For the same reasons, our additional
paid in capital decreased from $87,035,096 at December 31, 2000
to $10,877,152 at December 31, 2001.
Although our revenues continue to grow, until we produce enough
revenues to fund our operations, we will have to find additional
financing that we'll use to finance development of, and to
proceed to manufacture, our various projects. We can't assure
you that we'll be able to find that additional financing.
Our products are at various stages of development and we'll need
more money to complete them. We may decide to discontinue any of
our projects at any time if research and development efforts
dictate that's the best thing to do.
Our financial statements contain a going concern opinion from our
auditors. Our auditors issued that opinion because we have a
history of losses and very little revenue to support our
operations. We get money to fund our operations by selling
securities - and we don't know if we'll be able to continue to
raise enough money that way. Because we're not sure - and our
auditors are not sure - how long we can continue, our financial
statements include the auditor's opinion that we may not be able
to continue operating as a going concern. We have a history of
successful capital-raising efforts; since 1989, and through
December 2001, we, along with Diasense, have raised over
$183,000,000 in private and public offerings alone.
We think that our long-term liquidity needs will include working
capital to fund manufacturing expenses for our products and
continued research and development expenses for existing and
future projects. If our projects are delayed, we will need more
money. We believe we will be able to continue selling our stock
and other securities in order to raise funds, but we can't assure
you we will be successful. If we can't raise enough money to
fund our projects and operations, we will not be able to
continue. We don't have any other sources of funds, such as bank
lines of credit. We believe that, at some point, we will be able
to sell our products to generate revenue, but we can't assure you
when, or if, that will happen.
Results of Operations
The following ten paragraphs discuss the results of operations of
our entire company based on our consolidated financial
statements. We discuss our business segments at the end of this
section.
Our net sales and corresponding costs of products sold during
2001 increased to $4,342,203 and $3,287,176 respectively in 2001
from $340,327 and $354,511 in 2000, and $122,354 and $147,971 in
1999. The increase in 2001 was primarily due to sales of
$3,212,418 by Petrol Rem's subsidiary, INTCO, which was acquired
in the fourth quarter of 2000 and, therefore, not included in the
first nine months of 2000 or in 1999 operations. Petrol Rem's
increase also included an increase in bioremediation product
sales to $108,092 during 2001 compared to $53,758 during 2000 and
$26,693 in 1999. During the 3rd quarter, Petrol Rem received a
distribution agreement for approximately $125,000 per year from
an Alaskan oil spill clean-up company called F.R.O.G. to
distribute Petrol Rem products. The contract has an initial term
of one year, with automatic renewals on a yearly basis. Due to
recent international events, including the September 11th
tragedy, the Alaskan company has been focused on other matters,
and they've told us that they hope to begin selling our products
soon. Through Tireless, LLC, we received a sub-contract to help
clean up tire piles in Ohio. We began that project at the
beginning of October, and we recently began billing for our
services. We recognized revenues totaling $63,127 from the
Tireless project during 2001. We believe the Tireless sub-
contract could generate revenue of at least $500,000 over the
next year based on our equipment's capacity to shred tires over
the one-year period of the contract.
In addition, we recognized sales of $339,839 from our
hyperthermia products during 2001, which produced sales of
$69,605 during 2000 and no sales in 1999. The increase was due
to placements and installations of ViaCirq's ThermoChemHT system
and corresponding sales of disposables in several hospitals.
Other product sales increased in total, but not significantly.
In 2001, we received $112,091 from CCTI's metal coating products
compared with $40,593 in 2000 and no sales in 1999. The increase
in sales of metal coating products was due primarily to the
introduction of a product line for sharpeners used for knives and
other tools in the professional culinary field, for sportsmen's
knives and fish hooks, for professional woodworkers and for
household use. CCTI also continues to receive work from repeat
customers who sent us more work once they were satisfied with our
earlier performance. As part of an overall effort to cut costs
and operate more efficiently, we are in the process of trying to
sell CCTI.
During 2001, we recognized sales of $28,057 for our theraPORT, an
implantable device used by patients who have repeated injections
of drugs. The theraPORT is implanted in the patient's chest and
provides a fixed port for catheters used to deliver the drugs the
patient needs. Our 2001 theraPORT sales were higher than the
$20,068 in 2000 but lower than the $31,060 in 1999. We also
recognized sales of $38,400 for HIV tests marketed by Rapid HIV
Corporation for the first time during 2001, because we just
acquired our interest in Rapid HIV. Until we have significant
and consistent sales, we can't predict any trends for future
revenues. Our costs of products sold increased due to the
increase in sales of our various products.
During the 3rd quarter of 2001, our manufacturing division in
Indiana, PA received contracts, which began generating revenue
during late 2001. Our Biocontrol Technology division received a
$1.5 million manufacturing contract from the U.S. Army, and
$238,000 manufacturing contract from a private company. We began
work on the U.S. Army contract, which we believe will generate
$1.5 million in revenue during the first year, beginning in the
4th quarter of 2001, with additional revenue for two additional
years; we filed a copy of that contract as an exhibit to our Form
8-K/A filed October 15, 2001. During the 4th quarter of 2001,
our manufacturing division generated outside contract revenue
aggregating $410,998.
Research and Development expenses increased to $7,113,258 in 2001
from $6,651,471 in 2000 and $4,430,819 in 1999. The increase
was due to expenses incurred for the Diasensor clinical trials
partially offset by reduced research activities on our
hyperthermia products and the redeployment of resources from
research activities to production of hyperthermia products.
General and administrative expenses increased a total of
approximately $471,650 for 2001 as compared to 2000. The
increase is attributable to additional salaries, which include a
$912,727 payment to David L. Purdy in connection with his
resignation from the Company and its affiliates and new hiring at
ViaCirq and Petrol Rem (including INTCO and Tireless, LLC). Also
contributing to the increase was higher travel expenses,
primarily for ViaCirq's and Petrol Rem's increased marketing
efforts. The above increases were partially offset by a decrease
in expense recognized in connection with the granting of warrants
for services. Our total general and administrative expenses were
approximately $22 million in 2001, $21.4 million in 2000 and
$12.9 million in 1999.
Amortization increased from $392,307 to $804,458 for 2000 to
2001, and increased $352,591 from 1999 to 2000. The increases
are due to additional investments in unconsolidated subsidiaries
during 2000 and 2001 and our acquisition of the Rapid HIV
marketing rights in 2001. A portion of these investments is
recognized as goodwill and amortized over a five-year period.
Our loss on unconsolidated subsidiaries increased to $279,986 for
the year ended December 31, 2001 compared to $158,183 for the
same period in 2000, and zero in 1999. This loss results because
we absorb part of losses incurred by unconsolidated subsidiaries
and our investments began in 2000. Our share of the loss is
determined by applying our ownership percentage to the total loss
incurred.
Debt issue costs increased from $1,005,000 in 2000 to $2,218,066
in 2001, a decrease from $3,458,300 in 1999. The increase is due
to additional debentures and notes payable during 2001 compared
to 2000. We had more debentures outstanding in 1999 than either
2000 or 2001.
Beneficial conversion terms included in our convertible
debentures are recognized as expense and credited to additional
paid in capital at the time the associated debentures are issued.
We recognized $2,063,915 of expense in connection with the
issuance of our subordinated convertible debentures in 2001
compared to $3,062,500 for 2000 and $7,228,296 in 1999. The
amount varied because we issued fewer debentures this year
compared to last year, which was already a decrease from 1999.
Segment Discussion
For purposes of accounting disclosure, we provide the following
discussion regarding two business segments: Bioremediation and
environmental clean-up, which includes the operations of Petrol
Rem, Inc., and Biomedical devices, which includes the operations
of our Biocontrol Technology division, Diasense, Inc., and
ViaCirq, Inc. More complete financial information on these
segments is set forth in Note H to our accompanying financial
statements.
Bioremediation Segment. During the year ended December 31, 2001,
sales to external customers increased to $3,383,637 from $217,722
in 2000 and $26,693 in 1999. The increase from 2000 to 2001 is
primarily due to revenues from INTCO. The increase from 1999 to
2000 was due to our increased efforts to effectively penetrate
the market with products other than the BioSok. Costs of
products sold also increased to $2,507,717 in 2001 from $179,446
in 2000 and $14,683 in 1999, primarily to due INTCO's operations.
Biomedical Device Segment. During the year ended December 31,
2001, sales to external customers increased to $817,353 from
$81,954 in 2000 and $82,056 in 1999. The overall increase was
primarily due to increased revenues from our ThermoChem products.
Corresponding overall increases in costs of products goods sold
occurred for the same reason, from $133,288 in 1999 to $47,862 in
2000 and $558,408 in 2001.
Income Taxes
Due to our net operating loss carried forward from previous years
and our current year losses, no federal or state income taxes
were required to be paid for the years 1987 through 2001 on
BICO's consolidated tax return. However, INTCO, Inc., a
subsidiary of Petrol Rem, Inc., files separate income tax returns
and the 2001 tax return included tax expense of $120,882. As of
December 31, 2001, we and our subsidiaries, except for Diasense,
Petrol Rem, Rapid HIV and ICTI had available net operating loss
carry forwards for federal income tax purposes of approximately
$157 million, which expire over the course of the years 2002
through 2022.
Supplemental Financial Information
In February 2002, we accepted a $25 million funding commitment
from J.P. Carey Asset Management. The initial funding will be
through their purchase of $7.5 million of our Series K preferred
stock. We won't receive it until our registration statement
covering the 620 million shares needed to cover the Series K
conversions is declared effective. In addition, from October 2001
through January 2002, we raised funds aggregating approximately
$6.64 million by selling our convertible preferred stock. We
discuss the specific terms of our classes of preferred stock in the
Description of Securities section beginning on page 24 of this
document. Generally, the preferred stock is not secured by any
assets and can be converted into common stock at prices ranging
from 76-90% of our stock's average closing bid prices. There is
no minimum conversion price.
We filed a registration statement on Form S-1 in February, but
withdrew it so we could update our financial statements with our
audited statements for the year ended December. We plan to re-
file the registration statement in March 2002, and it will
include the shares of common stock that underlie our Series G, H,
I, J and K convertible preferred stock.
We recently obtained a $4 million bridge loan commitment to help us
meet our cash flow needs until the registration statement
covering the common stock underlying our preferred stock is
declared effective and we begin receiving funding from J.P. Carey
Asset Management. We have already recived $1 million on the bridge
loan financing which is being held in escrow until the filing of our
registration statement. We expect to receive another $1 million within
the next 15 days, and the balance within 45 days. The bridge loan is
repayable in one year. We plan to use the money from the bridge loan
to help us bring our payroll and accounts payable more current, to make
the class action payments and to fund continuing operations. However, we
can't assure you if that will happen, or if it will happen soon
enough to avoid lawsuits against us. We will use the money from
our Series K preferred stock to help repay our bridge loans.
We filed a Form S-8 in December 2001 that included 125 million
shares. The Form S-8 allows us to issue freely tradable stock to
non-executive employees under our Equity Compensation plan and to
certain consultants in lieu of paying them in cash. As of March
28, 2002, we've issued approximately 101.25 million shares of our
common stock from the Form S-8. We are preparing to file an
amendment to our Form S-8 to add another 200 million shares we
will use to retain consultants.
In the first quarter 2002 the Company's Board of Directors
directed Management to pursue the disposition of two consolidated
subsidiaries, Ceramic Coatings Technologies, Inc. (CCTI) and B-A-
Champ.com (dba TruePoints.com). We are currently negotiating
with a buyer for CCTI although we are not sure what the final
terms of sale might be.
Item 8. Financial Statements and Supplementary Data
The Company's financial statements appear on pages F-1 through
F-37 of this report.
Item 9. Changes in and Disagreements with Accountants on
Accounting and Financial Disclosure
Effective August 24, 2000, upon a determination by the board of
directors, we engaged Goff Backa Alfera & Company, LLC as our
independent auditors and accountants to replace Thompson Dugan,
P.C. Goff Backa Alfera & Company, LLC also serves as the
independent auditors and accountants for Diasense, replacing
Thompson Dugan, P.C. Neither company had any disagreements with
Thompson Dugan, P.C. or Goff Backa Alfera & Company, LLC on any
matter of accounting principles or practices, financial statement
disclosure or auditing scope or procedure.
Item 10. Directors and Executive Officers of the Registrant
Name Age Director Position
Since
Fred E. Cooper 56 1989 Chief Executive Officer,
Executive Vice President,
Director
Anthony J. Feola 53 1990 Chief Operating Officer,
Director
Michael P. Thompson 52 Chief Financial Officer
Glenn Keeling 50 1991 Senior Vice President,
Director
Ben Johnson 57 Executive Vice President
Stan Cottrell 58 1998 Director
Paul W. Stagg 54 1998 Director
FRED E. COOPER, 56, is our chief executive officer, executive
vice president and a director; he devotes approximately 60% of
his time to BICO, and 40% to Diasense. Prior to joining us, Mr.
Cooper co-founded Equitable Financial Management, Inc. of
Pittsburgh, PA, where he was the executive vice president until
he left in August 1990. Our board of directors appointed him
chief executive officer in January 1990. He is also an officer
and director of Diasense and Rapid HIV Detection Corp., and a
director of Petrol Rem and Coraflex.
ANTHONY J. FEOLA, 53, is our chief operating officer; he rejoined
BICO in April 1994, after serving as Diasense's vice president of
marketing and sales from January 1992 until April 1994. Prior to
January 1992, he was our vice president of marketing and sales.
Prior to joining us in November 1989, Mr. Feola was vice
president and chief operating officer with Gateway Broadcasting
in Pittsburgh in 1989, and national sales manager for
Westinghouse Corporation, also in Pittsburgh, from 1980 until
1989. He was elected a director in February 1990, and also
serves as the secretary of Rapid HIV Detection Corp. and a
director of Diasense, Coraflex, and Petrol Rem.
MICHAEL P. THOMPSON, 51, joined BICO as our interim chief
financial officer in August 2000, and was elected our chief
financial officer by our board of directors in January 2001.
Prior to joining us, he was a partner in Thompson Dugan, P.C.,
the CPA firm that served as our outside auditors until August
2000, when Mr. Thompson joined us as interim CFO. He has been a
CPA for over 25 years. He is also the chief financial officer for
Diasense and Petrol Rem, and a director of ViaCirq.
GLENN KEELING, 50, joined our board of directors in April 1991.
Mr. Keeling currently is a full-time employee of BICO in the
position of senior vice president; his primary responsibilities
are to manage our ViaCirq operations. From 1976 through 1991, he
was a vice president in charge of new business development at
Equitable Financial Management, Inc., a regional equipment
lessor. His responsibilities included initial contacts with
banks and investment firms to open new lines of business
referrals in connection with financing large equipment
transactions. He is also president and a director of ViaCirq.
BEN JOHNSON, 57, joined BICO in 2001 as our executive vice
president and the director of our Washington, DC office. Prior
to joining us, he spent from 1993-2001 on the staff for the
President of the United States. From 1999-2001, he was the
assistant to the President and director of the President's
Initiative for One America, the first freestanding White House
office in history to focus on closing the opportunity gap that
exists for minorities in the U.S. From 1997-1999, he was deputy
assistant to the President and deputy director of public liaison.
From 1993-1997, he served as special assistant to the President
and associate director of public liaison, the primary liaison to
the national African-American community. He also serves as an
officer and director of Rapid HIV Detection Corp.
STAN COTTRELL, 58, was appointed to our board of directors in
1998. Mr. Cottrell is the chairman and founder of Cottrell
Associates International, Inc., which provides international
business development, brokerage, specialty marketing and
promotional services. He is a former director of marketing for
Inhalation Therapy Services and was employed by Boehringer
Ingelheim, Ltd. as a national product manager. Mr. Cottrell is a
world ultra-distance runner and the author of several books.
PAUL W. STAGG, 54, was appointed to our board of directors in
1998. Mr. Stagg is the owner of P.C. Stagg, LLC. Prior to his
current position, he was the marketing manager for the Wholesale
Division of First Financial Resources, Inc., where he was
responsible for marketing, underwriting, sorting and coordinating
various types of financing for institutional investors. Prior to
his current position, he was district distributor of marketing
for Ginger Mae, a division of United Companies of Baton Rouge,
LA.
Item 405 of Regulation S-K requires us to make disclosures
regarding timely filings required by Section 16(a) of the
Securities and Exchange Act. Based solely on our review of
copies of forms received and written representations from certain
reporting persons, we believe that all of our officers, directors
and greater than ten percent beneficial owners complied with
applicable filing requirements.
Item 11. Executive Compensation
The following table contains information on our executive
officer's annual and long-term compensation for their services to
us in all capacities for the years ended December 31, 2001, 2000
and 1999. The executive officers included are those people who,
as of December 31, 2001 were: our chief executive officer, and
our other most highly compensated executive officers who were
paid more than $100,000. In addition, we included information
regarding David L. Purdy, who was an executive officer and
director until June 2000, and the president of our Biocontrol
Technology division during 2000. In November 2000, Mr. Purdy
resigned effective February 2001.
SUMMARY COMPENSATION TABLE
==============================================================================
Annual Compensation | (1)Long Term Compensation
- ------------------------------------------------------------------------------
| Awards
Name and | Securities
Principal Bonus($) Other | Underlying (4) All other
Position Year Salary($) (2) ($)(3) | Warrants(#) Compensation
==============================================================================
David L. |
Purdy (5) 2001 $989,265 $0 $0 | 0 $0
2000 $646,795 $200,000(6) $0 | 0 $0
1999 $450,000 $0 $0 | 4,000,000(4) $0
- ------------------------------------------------------------------------------
Fred E. 2001 $977,115 $0 $0 | 15,000,000(4) $0
Cooper, 2000 $939,000 $383,746(8) $0 | 0 $0
CEO (7) 1999 $821,242 $200,000 $0 | 4,000,000(4) $0
- ------------------------------------------------------------------------------
Anthony J. 2001 $660,248 $0 $0 | 10,000,000(4) $0
Feola , Sr. 2000 $633,850 $268,190(10) $0 | 0 $0
Vice Pres.(9) 1999 $500,886 $0 $0 | 2,000,000(4) $0
- ------------------------------------------------------------------------------
Glenn 2001 $483,732 $0 $0 | 8,000,000(4) $0
Keeling, VP 2000 $500,000 $93,190(12) $0 | 0 $0
(11) 1999 $302,083 $0 $0 | 2,000,000(4) $0
- ------------------------------------------------------------------------------
Michael P. 2001 $317,375 $0 $0 | 3,000,000(4) $0
Thompson, 2000 $103,243 $0 $0 | 1,000,000(4) $0
Chief Financial
Officer (13)
- ------------------------------------------------------------------------------
R. Ben 2001 $191,171 $0 $0 | 1,500,000(4) $0
Johnson,
Executive VP
(14)
(1) We do not currently have a Long-Term Incentive Plan, and no
payouts were made under any LTIP during the years 2001, 2000
or 1999. We issued warrants during those three years, which
we also discuss in Note 4. We do not have any retirement,
pension or profit-sharing programs for the benefit of our
directors, officers or other employees.
(2) The amounts shown include both cash bonuses and dollar
amounts reflecting stock bonuses. The footnotes that follow
break down the total amount for each executive officer. The
dollar amount shown for stock bonuses equals the number of
shares of stock granted multiplied by the stock price on the
grant date. This valuation does not take into account the
diminution in value attributable to the restrictions
applicable to the shares based on short-swing profit or
other restrictions.
(3) During the year ended December 31, 2001, the executive
officers received medical benefits under our group insurance
policy, including disability and life insurance benefits.
The total combined amount of all those benefits was less
than 10% of the total annual salary and bonus reported for
each executive officer.
(4) On May 23, 2001, we granted Mssrs. Cooper, Feola, Keeling
and Thompson warrants to purchase the number of shares
listed. All the warrants are exercisable at $.0525 per
share - a price greater than our trading price on May 23,
2001, until May 23, 2006. During 2001, we also issued
warrants to R. Ben Johnson, our new executive vice
president. We granted him warrants on July 30, 2001 that
give him the right to purchase 1 million shares of our
common stock at $.05 per share, until July 30, 2006; we also
issued him warrants on December 3, 2001 that give him the
right to purchase 500,000 shares of our common stock at $.05
per share until December 3, 2006. The $.05 exercise price
on Mr. Johnson's loans exceeds the market price on the dates
we issued the warrants. During 2000, we issued warrants to
Michael P. Thompson, our new chief financial officer. We
granted the warrants on August 28, 2000 that give him the
right to purchase 1 million shares of our common stock at
$.125 per share, which was the market price on the grant
date, until August 28, 2005. During 1999, we issued
warrants to the executive officers listed. All of the
warrants were issued on April 28, 1999 at $.129 per share,
which was the market price on the date of the warrant grant.
For more detailed information, please refer to the
"Option/Warrant/SAR Grants in Last Fiscal Year" table,
below.
(5) In 2001, we paid Mr. Purdy $912,727 by BICO, most of which
was a severance payment he demanded when he resigned. We
also paid him $26,923 from our Biocontrol Technology
division, and $49,615 from Diasense. In 2000, we paid Mr.
Purdy $196,795 by BICO and $450,000 by Diasense. In 1999,
he was paid $183,333 by BICO and $266,667 by Diasense. All
amounts are included in the table above. Mr. Purdy is paid
by BICO based on his employment agreement. Diasense paid
Mr. Purdy based on its board of director's decisions for
services performed on its behalf. In June 2000, Mr. Purdy
resigned as a BICO director and executive officer and became
the president of our Biocontrol Technology division. In
November 2000, he resigned from that position effective
February 2001.
(6) In 2000, we paid Mr. Purdy a cash bonus of $200,000 from
BICO.
(7) In 2001, we paid Mr. Cooper $336,281 by BICO; $414,167 by
Diasense; $80,000 each by Petrol Rem and ViaCirq; and
$66,667 by Rapid HIV. Due to our cash flow problems in the
last quarter of 2001, Mr. Cooper agreed to accrue a total of
$271,531 due him from all of the companies combined, rather
than collect that amount in 2001. In 2000, we paid Mr.
Cooper $250,000 by BICO; $497,000 by Diasense; and $96,000
each by Petrol Rem and ViaCirq. Part of his salary from
1998 was deferred and paid in 1999, and all amounts are
included in the table above. In 1999, he was paid $272,617
by BICO; $340,625 by Diasense and $104,000 each by Petrol
Rem and IDT, which is now ViaCirq All amounts are included
in the table above. Mr. Cooper is paid by BICO based on his
employment agreement. Amounts paid to Mr. Cooper by
Diasense, Petrol Rem, ViaCirq and Rapid HIV are determined
by the boards of directors of those companies based upon
services performed on their behalf.
(8) In 2000, we paid Mr. Cooper a cash bonus of $200,000 from
BICO. In addition, we gave him a stock bonus of 1 million
shares of our common stock. We determined the value of his
stock bonus, $183,746, using the stock price on the date of
the bonus, even though he hasn't sold the stock.
(9) In 2001, we paid Mr. Feola $472,748 by BICO and $187,500 by
Diasense. Due to our cash flow problems in the last quarter
of 2001, Mr. Feola agreed to accrue a total of $157,729 due
him from both companies, rather than collect that amount in
2001. In 2000, we paid Mr. Feola $408,850 by BICO and
$225,000 by Diasense. Part of his salary from 1998 was
deferred and paid in 1999, and all amounts are included in
the table above. In 1999, Mr. Feola was paid $425,886 by
BICO and $75,000 by Diasense. All amounts are included in
the table above. Mr. Feola is paid by BICO based on his
employment agreement. Diasense paid Mr. Feola based on its
board of director's decisions for services performed on its
behalf.
(10) In 2000, we paid Mr. Feola a cash bonus of $175,000 by BICO.
In addition, we gave him a stock bonus of 500,000 shares of
our common stock. We determined the value of his stock
bonus, $93,190, using the stock price on the date of the
bonus, even though he hasn't sold the stock.
(11) We pay Mr. Keeling based on his employment agreement. In
2001, 57% of the amounts paid were allocated to ViaCirq.
Due to our cash flow problems in the last quarter of 2001,
Mr. Keeling agreed to accrue $283,184 due him rather than
collect that amount in 2001. In 2000, 50% of his salary was
allocated to ViaCirq. In 1999, 87% of his salary was
allocated to IDT, now ViaCirq, based upon the time he
devoted to its operations.
(12) In 2000, we gave Mr. Keeling a stock bonus of 500,000 shares
of our common stock. We determined the value of his stock
bonus using the stock price on the date of the bonus, even
though he hasn't sold the stock.
(13) Mr. Thompson was appointed our interim chief financial
officer when he joined us in August 2000, and then appointed
chief financial officer in 2001. Due to our cash flow
problems in the last quarter of 2001, Mr. Thompson agreed to
accrue $52,474 due him rather than collect that amount in
2001. We pay him based on his employment agreement.
(14) Mr. Johnson was appointed our executive vice president when
he joined us in January 2001.
Option/Warrant/SAR Grants in Last Fiscal Year
POTENTIAL REALIZED
VALUE AT ASSUMED
ANNUAL RATES OF
STOCK
INDIVIDUAL GRANTS (1) PRICE APPRECIATION
FOR
OPTION TERM (3)
Percent of
Number of Total
Securities Options/SAR's Exercise
Underlying Granted to or Expiration
Options/ Employees in Base Date 5%($) 10%($) 0%($)
Name SAR's Fiscal Year Price
Granted (2) ($/Sh)
(#)
Fred E.
Cooper 15,000,000 31% $.0525 5/23/06 $ 0 $172,500 $0
Anthony J.
Feola 10,000,000 21% $.0525 5/23/06 $ 0 $115,000 $0
Glenn Keeling 8,000,000 16% $.0525 5/23/05 $ 0 $ 92,000 $0
Michael P.
Thompson 3,000,000 6% $.0525 5/23/06 $ 0 $ 34,500 $0
R. Ben
Johnson 1,000,000 7/30/06 $ 0 $ 0 $0
500,000 3% $ 0.05 12/03/06 $ 0 $ 0 $0
(1) The warrants in this table were granted during 2001.
The warrants granted the executive officers the right
to purchase the number of shares of common stock shown
in the table at the price shown for five years.
(2) For purposes of calculating this percentage, the total
number of warrants granted to employees during 2001 was
48.5 million.
(3) Potential realizable values reflect the difference
between the warrant exercise price at the end of 2001
and the fair value of our common stock price from the
date of the grant until the expiration of the warrant.
The 5% and 10% appreciation rates, compounded annually,
are assumed under to the rules adopted by the SEC and
do not reflect actual historical or projected rates of
appreciation of our common stock. Assuming such
appreciation, the following illustrates the per share
value on the dates set forth, which are the expiration
dates for the warrants, assuming the values set forth,
which are the closing bid price on the date of the
grant as reported by the electronic bulletin board:
STOCK PRICE ON EXPIRATION
DATE OF GRANT DATE 5% 10%
05/23/01: $0.04 05/23/06 $0.051 $0.064
07/30/01: $0.02 07/30/06 $0.025 $0.032
12/03/01: $.025 12/03/06 $0.032 $0.040
The foregoing values do not reflect appreciation
actually realized by executive officers. For more
information on the warrants, review the next table.
(4) The -0- amounts reflect the fact that, even at the end
of the warrant term, based on the appreciation rate,
the market price will be less than the exercise price.
AGGREGATED OPTION/WARRANT/SAR EXERCISES IN LAST FISCAL
YEAR AND FISCAL YEAR-END OPTION/WARRANT/SAR VALUE TABLE
Number of Value of
Securities Unexercised
Underlying In-the-Money
Unexercised Options/SARs
Options/SARs at
at 12/31/01 ($)
12/31/01 (#)
Name Shares Value Exercisable/ Exercisable/
Acquired Realized Unexerciseable Unexercisable
on ($)(2) (3) (4)
Exercise
(#)(1)
David L. 0 $ 0 3,767,200 $ 0
Purdy (5) (11)
Fred E. 0 $ 0 19,300,000 $ 0
Cooper (6) (11)
Anthony 0 $ 0 12,550,000 $ 0
J. Feola (7) (11)
Glenn 0 $ 0 10,100,000 $ 0
Keeling (8) (11)
Michael P. 0 $ 0 4,000,000 $ 0
Thompson (9) (11)
R. Ben 0 $ 0 1,500,000 $ 0
Johnson (10) (11)
__________________
(1) This figure represents the number of shares of common
stock acquired by each executive officer upon the
exercise of warrants. None of the executive officers
exercised warrants during 2000.
(2) The value realized of the warrants exercised is
computed by determining the difference between the
market value of our common stock on the exercise date
minus the exercise price of the warrant.
(3) All warrants held by the executive officers are
currently exercisable.
(4) The value of unexercised warrants was computed by
subtracting the exercise price of the outstanding
warrants from the closing sales price of our common
stock on the last trading day of December 2000 as
reported by the electronic bulletin board, which was
$.049.
(5) Includes warrants to purchase: 187,200 shares of
common stock at $.25 per share until April 24, 2001;
500,000 shares of common stock at $.25 per share until
May 1, 2001; 80,000 shares of common stock at $.33 per
share until June 29, 2003; and 3 million shares of
common stock at $.129 per share until April 28, 2004.
(6) Includes warrants to purchase: 300,000 shares of common
stock at $.25 per share until May 1, 2001; 4 million
shares of common stock at $.129 per share until April
28, 2004; and 15 million shares of common stock at
$.0525 per share until May 23, 2006.
(7) Includes warrants to purchase: 100,000 shares of
common stock at $.25 per share until May 1, 2001;
100,000 shares of common stock at $.25 per share until
November 26, 2003; 350,000 shares of common stock at
$.50 per share until October 11, 2002; 2 million shares
of common stock at $.129 per share until April 28,
2004; and 10 million shares of common stock at $.0525
per share until May 23, 2006.
(8) Includes warrants to purchase: 100,000 shares of common
stock at $1.48 per share until August 26, 2001; 2
million shares of common stock at $.129 per share until
April 28, 2004; and 8 million shares of common stock at
$.0525 per share until May 23, 2006.
(9) Includes warrants to purchase 1 million shares of
common stock at $.125 per share until August 28, 2005;
and 3 million shares of common stock at $.0525 per
share until May 23, 2006.
(10) Includes warrants to purchase 1,000,000 shares of
common stock at $.05 per share until July 30, 2006 and
500,000 shares of common stock at $.05 per share until
December 3, 2006.
(11) Because the market price as of the last trading day of
December 2001 was less than the exercise price of the
warrants, none of the warrants were in the money.
Employment Agreements
We have employment agreements with our executive officers,
Fred E. Cooper, Anthony J. Feola and Glenn Keeling effective
November 1, 1994, and Michael P. Thompson effective August
16, 2000. Under those agreements, they are currently
entitled to receive annual salaries of $400,000, $558,850,
$250,000 and $300,000 respectively, which are subject to
review and adjustment. The initial term of the agreements
with Mr. Cooper was renewed in October 1999 for an
additional three-year term, which will automatically renew
for additional three-year terms unless one of the parties
gives proper notice of non-renewal; in November 2000, Mr.
Purdy resigned effective February 2001. The initial term of
the agreements with Messrs. Feola and Keeling was renewed in
October 2001 for an additional two-year term, which will
automatically renew for additional two-year terms unless one
of the parties gives proper notice of non-renewal. ViaCirq
also has an employment agreement with Mr. Keeling, effective
December 3, 2000, under which he is entitled to receive an
annual salary of $350,000. The initial term of Mr.
Thompson's agreement will expire on August 31, 2005 and will
also automatically renew for additional two-year periods
unless one of the parties gives proper notice of non-
renewal. The agreements also provide that in the event of a
"change of control", we are required to issue the following
shares of common stock, represented by a percentage of our
total outstanding shares of common stock immediately after
the change in control: 5% to Mr. Cooper; 4% to Mr. Feola; 3%
to Mr. Keeling; and 2% to Mr. Thompson. In general, a
change of control would occur for purposes of the agreements
if: 20% or more of our outstanding voting stock is acquired
by any person; if 1/3 or more of our directors are not
continuing directors, as defined in the agreement; or when a
controlling influence over our management or policies is
exercised by any person or by persons acting as a group
within the meaning of Section 13(d) of the Securities
Exchange Act of 1934.
In addition, if there is a change in control during the term
of the agreements, or within one year afterwards, Messrs.
Cooper, Feola, Keeling and Thompson are entitled to receive
severance payments in amounts equal to: 100% of their most
recent annual salary for the first three years following
termination; 50% of their most recent annual salary for the
next two years; and 25% of their most recent salary for the
next five years. We are also required to continue medical
insurance coverage for Messrs. Cooper, Feola, Keeling and
Thompson and their families during those periods. Those
severance payments will terminate in the event of the
employee's death.
In the event that Mr. Cooper becomes disabled, as defined in
his agreements, he will be entitled to the following
payments, in lieu of salary. The disability payments would
be reduced by any amount paid directly to him under a
disability insurance policy if we provided one: 100% of his
most recent annual salary for the first three years; and 70%
of his most recent salary for the next two years. In the
event that either Mr. Feola, Mr. Keeling or Mr. Thompson
becomes disabled, as defined in their agreements, he will be
entitled to similar payments: 100% of his most recent annual
salary for the first year; and 70% of his most recent salary
for the second year.
Under the employment agreements, Messrs. Cooper, Feola,
Keeling and Thompson are required to protect our
confidential information during the term of the agreements
and they are restricted from competing with us for a period
of one year in specified states following the expiration or
termination of the agreements.
In addition to the employment agreements we just described,
we have employment agreements with two of our non-executive
officer employees effective November 1, 1994. The terms of
such agreements are similar to those described for Messrs.
Feola and Keeling above, with the following amendments: the
term of one agreement is from November 1, 1994 through
October 31, 2002, and is renewable for successive two-year
terms; the term of the other agreement was renewed for an
additional two-year term in October 1999, and will
automatically renew for additional two-year terms unless one
of the parties terminates the agreement. In the event of a
change in control, we are required to issue both employees
shares of common stock equal to 2% of our outstanding shares
of common stock immediately after the change in control.
Purdy Agreement
In February 2001, we entered into an agreement with David L.
Purdy in connection with his resignation from our affiliates
and us. The agreement required us to pay Mr. Purdy an
aggregate of $912,727 plus $100,000 to be placed in an
escrow account for his future attorney's fees. The
agreement contains confidentiality and release provisions
for both Mr. Purdy and us.
Item 12. Security Ownership of Certain Beneficial Owners
and Management
The following table sets forth the indicated
information as of December 31, 2001 with respect to each
person who we know is beneficial owner of more than 5% of
the outstanding common stock, each of our directors and
executive officers, and all of our directors and executive
officers as a group.
As of December 31, 2001, we had 2,450,631,111 shares of
our common stock outstanding. The table below shows the
common stock currently owned by each person or group,
including common stock underlying warrants, all of which are
currently exercisable, as of December 31, 2001. The left-
hand column sets forth the percentage of the total number of
shares of common stock outstanding as of December 31, 2001,
which would be owned by each named person or group if they
exercised of all of their warrants, together with common
stock they currently owned. An asterisk - * - means less
than 1%. Except as otherwise indicated, each person has the
sole power to vote and dispose of each of the shares listed
in the columns opposite his name.
Name and Amount and Percent of Beneficial
Address of Nature of Ownership of
Beneficial Beneficial Total Outstanding
Owner Ownership (1) Common Stock (2)
Fred E. Cooper 21,076,200 (3) *
2275 Swallow Hill Road
Bldg. 2500, 2nd Floor
Pittsburgh, PA 15220
Stan Cottrell 1,350,000 (4) *
4619 Westhampton Drive
Tucker, GA 30084
Anthony J. Feola 13,404,000 (5) *
2275 Swallow Hill Road
Bldg. 2500, 2nd Floor
Pittsburgh, PA 15220
Robert B. Johnson 1,500,000 (6) *
1140 Connecticut Ave., NW
11th Floor
Washington, DC 20036
Glenn Keeling 10,738,500 (7) *
2275 Swallow Hill Road
Building 2500,2nd Floor
Pittsburgh, PA 15220
Paul Stagg 1,570,000 (8) *
168 LaLanne Road
Madisonville, LA 70447
Michael P. Thompson 4,000,000 (9) *
2275 Swallow Hill Road
Bldg. 2500, 2nd Floor
Pittsburgh, PA 15220
All directors 53,638,700(10) 2.1%
and executive
officers as a
group (7 people)
NOTE: The officers and directors listed above entered into
agreements not to exercise the warrants set forth below
until August 2002. This means that the warrants are only
currently exercisable after that time.
(1) Includes ownership of all shares of common stock which
each named person or group has the right to acquire, through
the exercise of warrants, within sixty (60) days, together
with the common stock currently owned.
(2) Represents total number of shares of common stock owned
by each person, which each named person or group has the
right to acquire, through the exercise of warrants within
sixty (60) days, together with common stock currently owned,
as a percentage of the total number of shares of common
stock outstanding as of June 30, 2001. For individual
computation purposes, the total number of shares of common
stock outstanding as of June 30, 2001 has been increased by
the number of additional shares which would be outstanding
if the person or group exercised all outstanding warrants.
(3) Includes warrants to purchase the following: 300,000
shares of common stock at $.25 per share until May 1, 2003;
4,000,000 shares of common stock at $.129 per share until
April 28, 2004; and 15,000,000 shares of common stock at
$.0525 per share until May 23, 2006. In addition, Mr.
Cooper is entitled to certain shares of common stock upon a
change of control of BICO as defined in his employment
agreement.
(4) Includes warrants to purchase 250,000 shares of common
stock at $.129 per share until April 28, 2004; and warrants
to purchase 1,000,000 shares of common stock at $.0525 until
May 23, 2006.
(5) Includes warrants to purchase the following: 100,000
shares of common stock at $.25 per share until November 26,
2003; 100,000 shares of common stock at $.25 per share until
May 1, 2003; 350,000 shares of common stock at $.50 per
share until October 11, 2002; 2,000,000 shares of common
stock at $.129 per share until April 28, 2004; and
10,000,000 shares of common stock at $.0525 per share until
May 23, 2006. In addition, Mr. Feola is entitled to certain
shares of common stock upon a change of control of BICO as
defined in his employment agreement.
(6) Includes warrants to purchase the following: 500,000
shares of common stock at $.0730 per share until January 11,
2006; and 1,000,000 shares of common stock at $.05 per share
until July 30, 2006.
(7) Includes warrants to purchase 100,000 shares of common
stock at $1.48 per share until August 26, 2003; 2,000,000
shares of common stock at $.129 per share until April 28,
2004; and 8,000,000 shares of common stock at $.0525 per
share until May 23, 2006. In addition, Mr. Keeling is
entitled to certain shares of common stock upon a change of
control of BICO as defined in his employment agreement.
(8) Includes warrants to purchase 20,000 shares of common
stock at $.06 per share until April 27, 2003; 250,000 shares
of common stock at $.129 per share until April 28, 2004;
200,000 shares of common stock at $.102 per share until
February 1, 2006; and 1,000,000 shares of common stock at
$.0525 per share until May 23, 2006.
(9) Includes warrants to purchase 1,000,000 shares of common
stock at $.125 per share until August 28, 2005; and
3,000,000 shares of common stock at $.0525 per share until
May 23, 2006. In addition, Mr. Thompson is entitled to
certain shares of common stock upon a change of control of
BICO as defined in his employment agreement.
(10) Includes shares of common stock available under
warrants to purchase an aggregate as set forth above.
Item 13. Certain Relationships and Related Transactions
We share common officers and directors with our
subsidiaries. In addition, BICO and Diasense have entered
into several intercompany agreements including a purchase
agreement, a research and development agreement and a
manufacturing agreement, which we describe later in this
section. Our management believes that it was in our best
interest to enter into those agreements and that the
transactions were based upon terms as fair as those which
may have been available in comparable transactions with
third parties. However, we did not hire any unaffiliated
third party to determine independently the fairness of those
transactions. Our policy concerning related party
transactions requires the approval of a majority of the
disinterested directors of both the corporations involved,
if applicable.
Employment Relationships
Our board of directors approved employment agreements
on November 1, 1994 for our current officers, Fred E.
Cooper, Anthony J. Feola and Glenn Keeling, and approved an
employment agreement for Michael P. Thompson in August 2000.
Fred E. Cooper, chief executive officer, executive
vice president and a director, is a director of Diasense,
Petrol Rem, and Rapid HIV Detection Corp. He is also the
CEO of Rapid HIV Detection Corp and the president of
Diasense. Mr. Cooper devotes approximately 60% of his time
to BICO and 40% to Diasense. Anthony J. Feola, chief
operating officer and a director, is also the secretary of
Rapid HIV Detection Corp, and a director of Diasense, and
Petrol Rem. Glenn Keeling is our senior vice president and
a director. Mr. Keeling is also the president and a
director of ViaCirq. Michael P. Thompson is our chief
financial officer. He is also the chief financial officer
for Diasense and Petrol Rem, and a director of ViaCirq. Ben
Johnson, executive vice president and director of our
Washington, D.C. office, is also the executive vice
president and a director of Rapid HIV Detection Corp.
Property
Two of our current executive officers and/or directors
and three former directors are members of the nine-member
300 Indian Springs Road Real Estate Partnership that in July
1990 purchased our real estate in Indiana, Pennsylvania.
Each member of the partnership personally guaranteed the
payment of lease obligations to the bank providing the
funding. The five members of the partnership who are also
current or former officers and/or directors of BICO, David
L. Purdy, Fred E. Cooper, Glenn Keeling, Jack H. Onorato and
C. Terry Adkins, each received warrants on June 29, 1990 to
purchase 100,000 shares of our common stock at an exercise
price of $.33 per share until June 29, 1995. Those warrants
still outstanding as of the original expiration date were
extended until June 29, 2003. Mr. Purdy, who was a
director and executive officer at the time of the
transaction, resigned from our board of directors on June 1,
2000, and resigned as an officer in November 2000, effective
February 2001. Mr. Adkins, who was a director at the time
of the transaction, resigned from our board of directors on
March 30, 1992. Mr. Keeling, who was not a director at the
time of the transaction, joined our board of directors on
May 3, 1991. Mr. Onorato, who was not a director at the
time of the transaction, was a BICO director from September
1992 until April 1994. The property was sold in October
2000 for $475,000, and each of the partners received
$12,698, after the mortgage was paid.
Like all our warrants, the warrants issued to the
members of 300 Indian Springs Road Real Estate Partnership
had exercise prices equal to or above the current quoted
market price of our common stock on the date of issuance.
Warrants
On April 28, 1999, we granted warrants to purchase our
common stock at $.129 per share until April 28, 2004 in the
following amounts: 4,000,000 to Fred E. Cooper, our chief
executive officer and a director; 2,000,000 to Anthony J.
Feola, our chief operating officer and a director; 2,000,000
to Glenn Keeling, our senior vice president and a director;
4,000,000 to David L. Purdy, our former chairman and
director; 250,000 to Stan Cottrell, a director; and 250,000
to Paul Stagg, a director. The exercise price of $.129 per
share was equal to the market price on April 28, 1999.
On August 28, 2000, we granted warrants to purchase
1,000,000 shares of our common stock at $.125 per share
until August 28, 2005 to Michael P. Thompson, our chief
financial officer. The exercise price of $.125 per share
was equal to the market price on August 28, 2000.
On January 11, 2001, we granted warrants to purchase
500,000 shares of our common stock at $.073 per share until
January 11, 2006 to Ben Johnson, our executive vice
president. The exercise price of $.073 per share was equal
to the market price on January 11, 2001.
On February 1, 2001, we granted warrants to purchase
200,000 shares of our common stock at $.102 per share until
February 1, 2006 to Paul Stagg, a director. The exercise
price of $.102 per share was equal to the market price on
February 1, 2001.
On May 23, 2001, we granted warrants to purchase our
common stock at $.0525 per share until May 23, 2006 in the
following amounts: 15 million to Fred E. Cooper, our chief
executive officer and a director; 10 million to Anthony J.
Feola, our chief operating officer and a director; 8 million
to Glenn Keeling, our senior vice president and a director;
3 million to Michael P. Thompson, our chief financial
officer; 1 million to Stan Cottrell, a director and 1
million to Paul Stagg, a director. The exercise price of
$.0525 per share exceeded the market price on May 23, 2001.
On July 30, 2001, we granted warrants to purchase 1
million shares of common stock at $.05 per share until July
30, 2006 to Ben Johnson, our executive vice president. The
exercise price of $.05 per share exceeded the market price
on July 30, 2001.
On December 3, 2001, we granted warrants to purchase
500,000 shares of common stock at $.05 per share until
December 3, 2006 to Ben Johnson, our executive vice
president. The exercise price of $.05 per share exceeded
the market price on December 3, 2001.
Loans
In 1999, we consolidated all of Fred E. Cooper's
outstanding loans from us, including accrued interest, into
one loan in the amount of $777,399.80 at 8% interest. Mr.
Cooper began repaying the loans in May of 1999. The loan
balance as of December 31, 2001 was $678,021. Our
disinterested directors - with Mssrs. Cooper, Feola and
Keeling abstaining with respect to their individual
transactions- approved these loans because the disinterested
directors believed they were for a good business purpose.
The business purposes were: to provide Mr. Cooper with funds
during his initial years with BICO, when he waived a salary;
and to refinance loans secured by BICO stock, so the stock
wouldn't have to be sold when the loans were in default.
Mr. Cooper's individual loans, along with Mssrs. Feola and
Keeling's loans, had been, for period beginning in March
1996, secured by BICO certificates of deposits. Those CDs
were released in February 1998, when Mssrs. Cooper, Feola
and Keeling obtained loans from BICO and repaid the loans
which had been secured by BICO certificates of deposit. The
disinterested directors believed that if Mr. Cooper and the other
directors had been forced to sell their stock, and to
disclose the sale, it would have hurt our stock price
because many people view insider stock sales as a negative
message. In 2001, Mr. Cooper gave his stock in B-A-
Champ.com to BICO; he no longer owns any interest in B-A-
Champ.com.
In 1999, we consolidated all of Anthony J. Feola's
outstanding loans from us, including accrued interest, into
one loan in the amount of $259,476.82 at 8% interest. Mr.
Feola began repaying the loans in May of 1999. The loan
balance as of December 31, 2001 was $197,570. Our
disinterested directors - with Mssrs. Feola, Cooper and
Keeling abstaining with respect to their individual
transactions- approved these loans because the disinterested
directors believed they were for a good business purpose.
The business purposes was to refinance loans secured by BICO
stock, so the stock wouldn't have to be sold when the loans
were in default. Mr. Feola's individual loan, along with
Mssrs. Cooper and Keeling's loans, had been, for period
beginning in March 1996, secured by BICO certificates of
deposits. Those CDs were released in February 1998, when
Mssrs. Cooper, Feola and Keeling obtained loans from BICO
and repaid the loans which had been secured by BICO
certificates of deposit. The disinterested directors believed
that if Mr. Feola and the other directors had been forced to
sell their stock, and to disclose the sale, it would have hurt
our stock price because many people view insider stock sales as
a negative message.
In 1999, we consolidated all of Glenn Keeling's
outstanding loans from us, including accrued interest, into
one loan in the amount of $296,358.07 at 8% interest. Mr.
Keeling began repaying the loans in May of 1999. The loan
balance as of December 31, 2001 was $150,161. Our
disinterested directors - with Mssrs. Keeling, Feola and
Cooper abstaining with respect to their individual
transactions- approved these loans because the disinterested
directors believed they were for a good business purpose.
The business purposes was to refinance loans secured by BICO
stock, so the stock wouldn't have to be sold when the loans
were in default. Mr. Keeling's individual loan, along with
Mssrs. Cooper and Feola's loans, had been, for period
beginning in March 1996, secured by BICO certificates of
deposits. Those CDs were released in February 1998, when
Mssrs. Cooper, Feola and Keeling obtained loans from BICO
and repaid the loans which had been secured by BICO certificates
of deposit. The disinterested directors believed that if Mr.
Keeling and the other directors had been forced to sell their stock,
and to disclose the sale, it would have hurt our stock price
because many people view insider stock sales as a negative
message.
In September 1995, we granted a loan in the amount of
$250,000 to Allegheny Food Services in the form of a one-
year renewable note bearing interest at prime rate as
reported by the Wall Street Journal plus 1%. Interest and
principal payments have been made on the note, and as of
December 31, 2001, the balance was $24,394. Our board of
directors approved this loan because of its business purpose
- - in return for granting the loan, we received an option to
purchase a franchise owned by Joseph Kondisko, a former
director of Diasense, who is a principal owner of Allegheny
Food Services. The franchise generates revenue, which is
why we made the investment - until our products begin to
generate significant revenues;
In 2001, we granted a loan in the amount of $110,000 to
Anthony DelVicario, a former Diasense director and the
president of American Intermetallics. We loaned him the
money because he used it to try to close a transaction in
Europe that will generate revenues. The transaction
involves the creation of a distribution system in Europe to
sell American Inter-Metallic's products and generate
revenue. In November 2001, we increased the amount due to
$114,000 to cover accrued interest and secured the loan with all
of the assets of American Intermetallics. Mr. DelVicario began
making monthly payments on the loan in March 2002.
In April 2001, we loaned $70,000 to Pascal M. Nardelli,
President and Chief Executive Officer of Petrol Rem, Inc. In
August 2001, this demand note and accrued interest of $2,110
were paid in full.
All future loans to officers, directors and their affiliates
will also be made only after board approval, and for good
business purposes.
Consulting
In 2000, Thomas F. Feola, was engaged as an outside
consultant to assist with the identification and evaluation
of environmental companies for potential acquisitions,
mergers or strategic alliances. Thomas F. Feola is the
brother of Anthony J. Feola, COO and a director. We paid
Thomas Feola $64,000 in 2000 and $56,000 in 2001 for these
services which were terminated in August 2001.
Intercompany Agreements
Our management believes that the agreements between
BICO and Diasense, which are summarized below, were based
upon terms, which were as favorable as those that may have
been available in comparable transactions with third
parties. However, we did not retain any unaffiliated third
party to determine independently the fairness of such
transactions.
License and Marketing Agreement. Diasense acquired the
exclusive marketing rights for the noninvasive glucose
sensor and related products and services from BICO in August
1989 in exchange for 8,000,000 shares of Diasense's common
stock. That agreement was canceled through a cancellation
agreement dated November 18, 1991, and superseded by a
purchase agreement dated November 18, 1991. The
cancellation agreement provides that BICO will retain the
8,000,000 shares of Diasense common stock, which BICO
received under the license and marketing agreement.
Purchase agreement. BICO and Diasense entered into a
purchase agreement dated November 18, 1991 whereby BICO gave
Diasense its entire right, title and interest in the
noninvasive glucose sensor and its development, including
its extensive knowledge, technology and proprietary
information. Those transfers included BICO's patent
received in December 1991.
In consideration of the conveyance of its entire right in
the noninvasive glucose sensor and its development, BICO
received $2,000,000. In addition, Diasense may try, at its
own expense, to obtain patents on other inventions relating
to the noninvasive glucose sensor. Diasense also guaranteed
BICO the right to use that patented technology in the
development of BICO's proposed implantable closed-loop
system, a related system in the early stages of development.
In December 1992, BICO and Diasense executed an amendment to
the purchase agreement, which clarified terms of the
purchase agreement. The amendment defines sensors to
include all devices for the noninvasive detection of
analytes in mammals or in other biological materials. In
addition, the amendment provides for a royalty to be paid to
Diasense in connection with any sales by BICO of its
proposed closed-loop system.
Research and Development Agreement. Diasense and BICO
entered into an agreement dated January 20, 1992 in
connection with the research and development of the
noninvasive glucose sensor. Under the agreement, BICO will
continue the development of the noninvasive glucose sensor,
including the fabrication of prototypes, the performance of
clinical trials, and the submission to the FDA of all
necessary applications in order to obtain market approval
for the noninvasive glucose sensor. BICO will also
manufacture the models of the noninvasive glucose sensor to
be delivered to Diasense for sale under the terms of a
manufacturing agreement. Upon the delivery of the completed
models, the research and development phase of the
noninvasive glucose sensor will be deemed complete.
Diasense agreed to pay BICO $100,000 per month for indirect
costs beginning April 1, 1992, during the 15 year term of
the agreement, plus all direct costs, including labor. BICO
also received a first right of refusal for any program
undertaken to develop, refine or improve the noninvasive
glucose sensor, and for the development of other related
products. In July 1995, BICO and Diasense agreed to suspend
billings, accruals of amounts due and payments under to the
research and development agreement pending the FDA's review.
Manufacturing Agreement. BICO and Diasense entered into an
agreement dated January 20, 1992, whereby BICO will act as
the exclusive manufacturer of the noninvasive glucose sensor
and other related products. Diasense will provide BICO with
purchase orders for the products and will endeavor to
provide projections of future quantities needed. The
original manufacturing agreement called for the products to
be manufactured and sold at a price to be determined in
accordance with the following formula: Cost of Goods,
including actual or 275% of overhead, whichever is lower,
plus a fee of 30% of cost of goods. In July 1994, the
formula was amended to be as follows: costs of goods sold
was defined as BICO's aggregate cost of materials, labor and
associated manufacturing overhead + a fee equal to one third
of the difference between the cost of goods sold and
Diasense's sales price of each sensor. Diasense's sales
price of each sensor is defined as the price paid by any
purchaser, whether retail or wholesale, directly to Diasense
for each sensor. Subject to certain restrictions, BICO may
assign its manufacturing rights to a subcontractor with
Diasense's written approval. The term of the agreement is
fifteen years.
Item 14. Exhibits, Financial Statement Schedules, and
Reports on Form 8-K
(a) 1. Financial Statements
The financial statements, together with the report thereon
of the Company's independent accountants, are included in
this report on the pages listed below.
Financial Statements Page
Report of Independent Certified Public Accountants
Goff Backa Alfera & Company, LLC F-1
Consolidated Balance Sheets
December 31, 2001 and 2000 F-2
Consolidated Statements of Operations
for the years ended December 31, 2001, 2000 and 1999 F-4
Consolidated Statements of Stockholders' Equity
for the years ended December 31, 2001, 2000 and 1999 F-5
Consolidated Statements of Cash Flows
for the years ended December 31, 2001, 2000 and 1999 F-6
Notes to Consolidated Financial Statements
December 31, 2001, 2000 and 1999 F-8
2. Exhibits:
(b) Reports on Form 8-K
The Company filed a Form 8-K report on November 20,
2001, for the event dated November 11, 2001. The
items listed were Item 5, Other Events; and Item 7(c),
Exhibits.
The Company filed a Form 8-K report on November 30,
2001, for the event dated November 30, 2001. The items
listed were Item 5, Other Events; and Item 7(c),
Exhibits.
The Company filed a Form 8-K report on December 10,
2001, for the event dated December 6, 2001. The item
listed was Item 5, Other Events; and Item 7(c),
Exhibits.
The Company filed a Form 8-K report on January 3, 2002,
for the event dated January 3, 2002. The items listed
were Item 5, Other Events; and Item 7(c), Exhibits.
The Company filed a Form 8-K report on January 18,
2002, for the event dated January 17, 2002. The items
listed were Item 5, Other Events; and Item 7(c),
Exhibits.
The Company filed a Form 8-K report on January 24, 2002
for the event dated January 23, 2002. The items listed
were Item 5, Other Events; and Item 7(c), Exhibits.
The Company filed a Form 8-K report on January 25, 2002
for the event dated January 24, 2002. The items listed
were Item 5, Other Events; and Item 7(c), Exhibits.
The Company filed a Form 8-K report on February 19,
2002 for the event dated February 19, 2002. The Items
listed were Item 5, Other Events; and Item 7(c),
Exhibits.
The Company filed a Form 8-K report on March 8, 2002
for the event dated March 8, 2002. The Items listed
were Item 5, Other Events; and Item 7(c), Exhibits.
The Company filed a Form 8-K report on March 14, 2002
for the event dated March 13, 2002. The Items listed
were Item 5, Other Events; and Item 7(c), Exhibits.
The Company filed a Form 8-K report on March 14, 2002
for the event dated March 14, 2002. The Items listed
were Item 5, Other Events; and Item 7(c), Exhibits.
(c) Exhibits Required by Item 601 of Regulation S-K
The following exhibits required by Item 601 of Regulation
S-K are filed as part of this report. Except as otherwise
noted, all exhibits are incorporated by reference from
exhibits to Form S-1 (Registration #33-55200) filed December
1, 1992 or from exhibits to Form 10-K filings prior to or
subsequent to that date.
3.1(4) Articles of Incorporation as filed March 20, 1972
3.2(4) Amendment to Articles filed May 8,1972
3.3(4) Restated Articles filed June 19,1975
3.4(4) Amendment to Articles filed February 4,1980
3.5(4) Amendment to Articles filed March 17,1981
3.6(4) Amendment to Articles filed January 27,1982
3.7(4) Amendment to Articles filed November 22,1982
3.8(4) Amendment to Articles filed October 30,1985
3.9(4) Amendment to Articles filed October 30,1986
3.10(4) By-Laws
3.11(5) Amendment to Articles filed December 28,1992
3.12(8) Amendment to Articles filed February 7, 2000
3.13(12) Amendment to Articles filed June 14, 2000
3.14 Amendment to Articles filed November 30, 2001
3.15 Certificate of Designation of Series G Preferred
Stock
3.16 Certificate of Designation of Series H Preferred
Stock
3.17 Certificate of Designation of Series I Preferred Stock
3.18 Certificate of Designation of Series J Preferred Stock
3.19 Certificate of Designation of Series K Preferred Stock
10.1(1) Manufacturing Agreement
10.2(1) Research and Development Agreement
10.3(1) Termination Agreement
10.4(1) Purchase Agreement
10.5(2) Sublicensing Agreement and Amendments
10.6(3) Lease Agreement with 300 Indian Springs Partnership
10.7(4) Lease Agreement with Indiana County
10.8(5) First Amendment to Purchase Agreement dated
December 8, 1992
10.9(6) Fred E. Cooper Employment Agreement dated November
1, 1994
10.10(6) David L. Purdy Employment Agreement dated November
1, 1994
10.11(6) Anthony J. Feola Employment Agreement dated November
1, 1994
10.12(6)Glenn Keeling Employment Agreement dated November
1, 1994
10.13(9) David L. Purdy resignation as a director letter
dated June 1, 2000
10.14(11)Michael P. Thompson Employment Agreement dated
August 16, 2000
10.15(13)Marketing Agreement by and between BICO, Rapid HIV
Detection Corp., GAIFAR and Dr. Heinrich Repke
10.16(13)Contract between Biocontrol Technology, Inc. and
U.S. Army Assistance
16.1(7) Disclosure and Letter Regarding Change in Certifying
Accountants dated January 25, 1995
16.2 (10)Disclosure and Letter Regarding Change in
Certifying Accountants dated August 24, 2000
(1) Incorporated by reference from Exhibit with this
title filed with BICO's Form 10-K for the year ended
December 31, 1991
(2) Incorporated by reference from Exhibit with this
title to Form 8-K dated May 3, 1991
(3) Incorporated by reference from Exhibit with this
title to Form 10-K for the year ended December 31, 1990
(4) Incorporated by reference from Exhibit with this
title to Registration Statement on Form S-1 filed on
December 1, 1992
(5) Incorporated by reference from Exhibit with this
title to Amendment No. 1 to Registration Statement on Form S-
1 filed on February 8, 1993
(6) Incorporated by reference from Exhibit with this
title to Form 10-K for the year ended December 31, 1994
(7) Incorporated by reference from Exhibit with this title
to Form 8-K dated January 25, 1995
(8) Incorporated by reference from Exhibit with this title
to Form 10-K for the year ended December 31, 1999
(9) Incorporated by reference from Exhibit with this title
to Form 8-K dated June 2, 2000
(10) Incorporated by reference from Exhibit with this title
to Form 8-K filed August 24, 2000
(11) Incorporated by reference from Exhibit with this title
to Form 10-K for the year ended December 31, 2000
(12) Incorporated by reference from Exhibit with this title
to Form S-1 filed July 9, 2001
(13) Incorporated by reference from Exhibit with this title
to Form 8-K/A filed October 15, 2001
Conformed Copy
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of
the Securities Exchange Act of 1934, the Company has duly
caused this report to be signed on its behalf by the
undersigned, thereunto duly authorized, on the 1st day of
April 2002.
BICO, INC.
/s/ Fred E. Cooper
By: Fred E. Cooper
CEO, principal executive
officer and director
Pursuant to the requirements of the Securities Exchange
Act of 1934, the following persons on behalf of the
Registrant and in the capacities and on the dates indicated
have signed this report below.
Signature Title Date
/s/ Anthony J. Feola Senior Vice President, April 1, 2002
Anthony J. Feola Director
/s/ Michael P. Thompson Chief Financial Officer, April 1, 2002
Michael P. Thompson principal financial officer,
principal accounting officer
/s/ Glenn Keeling Director April 1, 2002
Glenn Keeling
/s/ Stan Cottrell Director April 1, 2002
Stan Cottrell
/s/ Paul W. Stagg Director April 1, 2002
Paul W. Stagg
Report of Independent Accountants
The Board of Directors and Stockholders
BICO, Inc.
We have audited the accompanying consolidated balance sheets
of BICO, Inc. and its subsidiaries as of December 31, 2001 and
2000, and the related consolidated statements of operations,
stockholders' equity (deficiency) and cash flows for each of the
three years in the period ended December 31, 2001. These
consolidated financial statements are the responsibility of the
Company's management. Our responsibility is to express an
opinion on these consolidated financial statements based on our
audits.
We conducted our audits in accordance with U.S. generally
accepted auditing standards. Those standards require that we
plan and perform the audit to obtain reasonable assurance about
whether the financial statements are free of material
misstatement. An audit includes examining, on a test basis,
evidence supporting the amounts and disclosures in the financial
statements. An audit also includes assessing the accounting
principles used and significant estimates made by management, as
well as evaluating the overall financial statement presentation.
We believe that our audits provide a reasonable basis for our
opinion.
In our opinion, the consolidated financial statements
referred to above present fairly, in all material respects, the
consolidated financial position of BICO, Inc. and its
subsidiaries as of December 31, 2001 and 2000, and the
consolidated results of its operations and its cash flows for
each of the three years in the period ended December 31, 2001, in
conformity with U.S. generally accepted accounting principles.
The accompanying consolidated financial statements have been
prepared assuming that the Company will continue as a going
concern. As discussed in note B to the financial statements, the
Company has incurred losses from operations and negative cash
flows from operations for each of the three years in the period
ended December 31, 2001, and these conditions are expected to
continue through 2002, raising substantial doubt about its
ability to continue as a going concern. Management's plans in
regard to these matters are also discussed in note B. The
financial statements do not include any adjustments that might
result from the outcome of this uncertainty, including
adjustments relating to the recoverability and classification of
recorded assets that might be necessary in the event the Company
cannot continue to meet its financing requirements and achieve
productive operations.
Goff Backa Alfera & Company, LLC
Pittsburgh, Pennsylvania
February 28, 2002
(except for Note S, as to which
the date is March 29, 2002)
BICO, Inc. and Subsidiaries
Consolidated Balance Sheets
Dec. 31, 2001 Dec. 31, 2000
------------- -------------
CURRENT ASSETS
Cash and equivalents (note A) $ 268,095 $ 7,844,807
Accounts receivable - net of allowance for doubtful accounts
of $43,664 at Dec. 31, 2001 and 2000 1,235,957 400,950
Inventory - net of valuation allowance (notes A and D) 1,190,796 805,224
Related party notes receivable (notes C and O) 138,394 87,706
Notes receivable (note C) - 12,000
Notes receivable-Practical Environmental Sol.,Inc.(note C) - 1,914,363
Interest receivable (note C) 144,411 48,252
Prepaid expenses (note E) 1,055,901 988,354
Other current assets 62,268 47,268
------------- -------------
TOTAL CURRENT ASSETS 4,095,822 12,148,924
PROPERTY, PLANT AND EQUIPMENT (notes A and K)
Building 2,566,777 2,529,176
Land 246,250 246,250
Leasehold improvements 2,071,629 1,848,674
Machinery and equipment 7,526,201 6,405,594
Furniture, fixtures & equipment 937,607 921,195
------------- -------------
13,348,464 11,950,889
Less accumulated depreciation 6,151,384 5,288,910
------------- -------------
7,197,080 6,661,979
OTHER ASSETS
Related Party Receivables
Notes receivable - (notes C and O) 1,036,293 1,174,738
Interest receivable - (notes C and O) 14,406 13,463
------------- -------------
1,050,699 1,188,201
Allowance for related party receivables (1,050,699) (1,188,201)
------------- ------------
- -
Notes receivable - (note C) 111,041 200,000
Notes receivable-Practical Environmental Sol., Inc. (note C) 3,148,404 -
Goodwill, net of amortization (notes A and R) 595,217 694,895
Intangible assets - marketing rights (Note F) 6,866,398 -
Investment in unconsolidated subsidiaries-(notes A and G) 2,409,843 2,061,439
Other assets 213,616 162,833
------------- -------------
13,344,519 3,119,167
------------- -------------
TOTAL ASSETS $ 24,637,421 $21,930,070
============= =============
The accompanying notes are an integral part of these statements.
F-2
BICO, Inc. and Subsidiaries
Consolidated Balance Sheets
(Continued)
Dec.31, 2001 Dec. 31, 2000
------------ -------------
CURRENT LIABILITIES
Accounts payable $ 4,755,445 $ 578,520
Notes payable (note J) 7,037,198 1,069,127
Current portion of long-term debt (note J) 86,420 4,113,656
Current portion of capital lease obligations (note K) 75,523 98,788
Debentures payable (note L) - 2,400,000
Accrued liabilities (note I) 2,568,526 3,131,765
Escrow payable (note M) 2,700 2,700
------------ -------------
TOTAL CURRENT LIABILITIES 14,525,812 11,394,556
LONG-TERM LIABILITIES
Capital lease obligations (note K) 2,128,149 2,203,673
Long-term debt (note J) 127,777 7,864
Other 25,009 -
------------- -------------
2,280,935 2,211,537
COMMITMENTS AND CONTIGENCIES (note P)
UNRELATED INVESTORS'INTEREST
IN SUBSIDIARIES (note A) 293,527 434,990
STOCKHOLDERS' EQUITY (note M)
Common stock, par value $.10 per share,
authorized 4,000,000,000 shares at Dec. 31,
2001 and 1,700,000 shares at Dec. 31, 2000, outstanding
2,450,631,111 shares at Dec. 31, 2001 and 1,383,704,167
at Dec. 31, 2000 245,063,111 138,370,417
Convertible preferred stock, par value $10
per share, authorized 500,000 shares issuable in
series, shares issued and outstanding 16,930 at
December 31, 2001 and none at December 31, 2000. 169,300 -
Discount assigned to beneficial conversion feature -
preferred stock (note M) (141,000) -
Additional paid-in capital 10,887,152 87,035,096
Warrants 6,221,655 6,204,235
Accumulated deficit (254,663,071) (223,720,761)
------------- -------------
TOTAL STOCKHOLDERS' EQUITY 7,537,147 7,888,987
------------- --------------
TOTAL LIABILITIES AND
STOCKHOLDERS' EQUITY $ 24,637,421 $ 21,930,070
============= =============
The accompanying notes are an integral part of these statements.
F-3
BICO, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
Year Ended December 31,
2001 2000 1999
------------- ------------- -------------
Revenues
Net sales $4,342,203 $ 340,327 $ 112,354
Other income 7,715 5,547 52,897
------------- ------------- -------------
4,349,918 345,874 165,251
Costs and expenses
Cost of products sold 3,287,176 354,511 147,971
Research and development (notes A,M and N) 7,113,258 6,651,471 4,430,819
General and administrative (note M) 21,879,130 21,407,472 12,884,237
Amortization (notes A,F and G) 804,458 392,307 39,716
Impairment loss - - 5,060,951
------------- ------------- -------------
33,084,022 28,805,761 22,563,694
------------- ------------- -------------
Loss from operations (28,734,104) (28,459,887) (22,398,443)
Other income and expense
Interest income (561,817) (589,529) (1,031,560)
Debt issue costs (note A) 2,218,066 1,005,000 3,458,300
Beneficial convertible debt feature(notes A&L) 2,063,915 3,062,500 7,228,296
Interest expense 826,346 1,924,873 1,373,404
Warrant extensions (note M) - 5,233,529 4,669,483
Loss on unconsolidated subsidiaries(notes A&G) 279,978 158,183 -
Loss on disposal of assets 29,759 122,857 376
Other taxes (note N) 120,882 - -
Unusual item (note J and P) (2,562,848) 3,450,000 -
------------- ------------- -------------
2,414,281 14,367,413 15,698,299
------------- ------------- -------------
Loss before unrelated
investors' interest (31,148,385) (42,827,300) (38,096,742)
Unrelated investors' interest in
net loss of subsidiaries 206,075 280,997 24,164
------------- -------------- -------------
Net loss $(30,942,310) $(42,546,303) $(38,072,578)
============= ============== =============
Loss per common share - Basic:
Net Loss $ (0.02) $ (0.04) $ (0.05)
Less: Preferred stock dividends (0.00) (0.00) (0.00)
------------- ------------- -------------
Net loss attributable to
common stockholders: $ (0.02) $ (0.04) $ (0.05)
============= ============= =============
Loss per common share - Diluted:
Net Loss $ (0.02) $ (0.04) $ (0.05)
Less: Preferred stock dividends (0.00) (0.00) (0.00)
------------- ------------- -------------
Net loss attributable to
common stockholders: $ (0.02) $ (0.04) $ (0.05)
============= ============= =============
The accompanying notes are an integral part of these statements.
F-4
BICO, Inc. and Subsidiaries
Consolidated Statements of Stockholders' Equity (Deficiency)
Note rec.
Preferred Stock Discount assigned Common Stock issued for Additional
--------------- to benef. conv. ------------ Common Stk Paid in Accumulated
Shares Amount feature Shares Amount Warrants Rel Party Capital Deficit Total
------ ------ ---------- ------ ------ ---------- --------- ----------- -------------- ----------
Balance at
Dec. 31, 1998 - $ - $ - 420,773,568 $42,077,357$6,396,994 $(25,000)$92,725,285 $(143,101,880) $(1,927,244)
------- ------- --------- ---------- ---------- ---------- -------- ---------- ------------ ----------
Proceeds from
stk offering - - - 19,625,691 1,962,569 - - (914,485) - 1,048,084
Proceeds from
sale of Preferred
stk.-Series F 72,000 720,000 - - - - - 90,000 - 810,000
Conversion of
debentures - - - 515,013,737 51,501,374 - - (19,444,872) - 32,056,502
Warrants granted
and extended-
subsidiaries - - - - - - - 5,897,332 - 5,897,332
Issuance of
convertible debt - - - - - - - 7,228,296 - 7,228,296
Repayment of
subscription recv. - - - - - - 25,000 - - 25,000
Warrants exercised - - - 687,500 68,750 (8,968) - 26,636 - 86,418
Warrants granted - - - - 403,135 - - - - 403,135
Net loss - - - - - - - - (38,072,578) (38,072,578)
------ ------- --------- ---------- ---------- --------- ------- --------- ----------- ----------
Balance at
Dec. 31,1999 72,000 720,000 - 956,100,496 95,610,050 6,791,161 - 85,608,192 (181,174,458) 7,554,945
------ ------- --------- ---------- ---------- --------- ------- --------- ----------- ---------
Proceeds from
stk offering - - - 327,615,231 32,761,523 - - (14,156,873) - 18,604,650
Proceeds from
sale of Preferred
stk.-Series F 380,000 3,800,000 (1,883,333) - - - - 2,358,333 - 4,275,000
Constructive div.
on preferred stk. - - 1,883,333 - - - - (1,883,333) - -
Conversion of
preferred stk.
Series F (452,000)(4,520,000) - 56,679,610 5,667,961 - - (1,147,961) - -
Conversion of
debentures - - - 36,294,340 3,629,434 - - 491,113 - 4,120,547
Warrants
exercised - - - 4,414,490 441,449 (307,581) - 481,790 - 615,658
Warrants
granted and extended
-subsidiaries - - - - - - - 11,084,555 - 11,084,555
Issuance of
convertible debt - - - - - - - 3,062,500 - 3,062,500
Common stk.
issued for serv. - - - 2,600,000 260,000 - - 78,000 - 338,000
Common stk.
issued-subs. - - - - - - - 170,780 - 170,780
Warrants granted - - - - - 608,655 - - - 608,655
Warrants expired - - - - - (888,000) - 888,000 - -
Net loss - - - - - - - - (42,546,303) (42,546,303)
------ ------- ------- ------------- ---------- ---------- ------- ---------- ----------- -----------
Balance at
Dec. 31, 2000 - $ - $ - 1,383,704,167$138,370,417$6,204,235 $ - $87,035,096 $(223,720,761) $ 7,888,987
------ ------- ------- ------------- ---------- ---------- ------- ---------- ----------- -----------
Proceeds from
stk offering - - - 769,410,092 76,941,009 - - (67,717,009) - 9,224,000
Preferred stk.
-Series G 10,530 105,300(1,662,632) - - - - 6,822,332 - 5,265,000
Preferred stk.
-Series H 2,000 20,000 (250,000) - - - - 1,070,000 - 840,000
Preferred stk.
-Series I 4,000 40,000 - - - - - 1,960,000 - 2,000,000
Preferred stk.
-Series J 400 4,000 (50,000) - - - - 226,000 - 180,000
Constructive
dividend on
preferred stock - - 1,821,632 - - - - (1,821,632) - -
Conversion of
debentures - - - 297,516,852 29,751,685 - - (19,096,026) - 10,655,659
Warrants
granted and extended
-subsidiaries - - - - - - - (1,331) - (1,331)
Issuance of
convertible debt - - - - - - - 2,058,970 - 2,058,970
Common stk.
issued-subs. - - - - - - - 162,500 - 162,500
Warrants granted - - - - - 17,420 - 188,252 - 205,672
Net loss - - - - - - - - (30,942,310) (30,942,310)
------ ------- ------- ------------- ---------- ---------- ------- ---------- ----------- -----------
Balance at
Dec. 31, 2001 - $ - $(141,000) 1,383,704,167$138,370,417$6,204,235 $ - $87,035,096 $(223,720,761) $ 7,888,987
====== ======= ======= ============= =========== ========== ======= ========== =========== ===========
The accompanying notes are an integral part of these statements.
F-5
BICO, Inc. and Subsidiaries
Consolidated Statements of Cash Flows
Year ended December 31,
2001 2000 1999
------------- ------------- -------------
Cash flows used by operating activities:
Net loss $(30,942,310) $(42,546,303) $(38,072,578)
Adjustments to reconcile net loss to net
cash used by operating activities:
Depreciation 977,178 689,762 773,696
Amortization 804,453 392,307 42,149
Loss on disposal of assets 29,759 122,857 177,000
Loss on unconsolidated subsidiaries 279,978 158,183 -
Unrelated investors' interest in susidiaries (206,078) (280,997) (24,164)
Stock issued in exchange for services - 338,000 148,484
Stock issued in exchange for services by subsidiary - 225,000 -
Debenture interest converted to stock - 120,547 211,503
Beneficial convertible debt feature 2,063,915 3,062,500 7,228,296
Provision for (recovery of)potential loss on notes receivable (137,502) (152,359) 70,253
Warrants granted 17,420 608,655 403,135
Warrants granted and extended by subsidiaries 188,252 11,184,858 5,897,332
(Decrease)increase in allowance for losses on accounts receivable - (20,015) 36,620
(Increase) in accounts receivable (835,007) (25,148) (7,924)
Decrease in inventories 1,303,127 101,480 90,052
(Decrease) in inventory valuation allowance (1,688,699) (859,283) (25,845)
(Increase) in prepaid expenses (67,547) (651,305) (21,702)
(Increase) decrease in other assets (113,051) 33,834 (146,408)
Increase (decrease) in accounts payable 4,176,925 (296,657) (949,578)
Increase in other liabilities 820,451 1,112,211 697,726
Debt forgiveness (2,562,848) - -
Impairment loss - - 5,060,951
------------- ------------- -------------
Net cash flow used by operating activities (25,891,584) (26,681,873) (18,411,002)
------------- ------------- -------------
Cash flows from investing activities:
Purchase of property, plant and equipment (1,542,038) (1,388,508) (641,371)
Disposal of property, plant and equipment - - 175,000
Acquisitions, net of cash acquired - (1,395,126) -
(Increase) in notes receivable (1,429,041) (1,939,073) (337,928)
Payments received on notes receivable 383,716 378,817 141,974
(Increase) in interest receivable (97,102) (32,756) (25,774)
Purchase of marketing rights (1,285,000) - -
Acquisition of unconsolidated subsidiaries (1,093,948) (2,078,520) (525,000)
------------- ------------- -------------
Net cash used by investing activites (5,063,413) (6,455,166) (1,213,099)
------------- ------------- -------------
Cash flows from financing activities:
Proceeds from stock offering 10,677,600 18,604,650 900,000
Proceeds from warrants exercised - 615,658 86,018
Proceeds from sale of preferred stock 6,285,000 4,275,000 810,000
Redemption of stock subscriptions (1,453,600) - -
Proceeds from debentures payable 8,255,659 12,250,000 33,150,000
Payments on debentures payable - (5,850,000) (4,130,000)
Payments on notes payable and long-term debt (14,408,087) (53,125) (465,650)
Increase in notes payable and long-term debt 14,120,502 855,801 75,396
Payments on capital lease obligations (98,789) (543,769) (99,777)
------------- ------------- -------------
Net cash provided by financing activities 23,378,285 30,154,215 30,325,987
_____________ _____________ _____________
Net increase (decrease) in cash (7,576,712) (2,982,824) 10,701,886
Cash and cash equivalents, beginning of year 7,844,807 10,827,631 125,745
------------- ------------- -------------
Cash and cash equivalents, end of year $ 268,095 $ 7,844,807 $ 10,827,631
============= ============= =============
The accompanying notes are an integral part of these statements.
F-6
BICO, Inc. and Subsidiaries
Consolidated Statements of Cash Flows
(Continued)
Year ended December 31,
2001 2000 1999
------------- ------------- -------------
Supplemental Information:
Interest paid $ 412,239 $ 1,485,286 $ 966,713
============= ============ ============
Supplemental schedule of non-cash
investing and financing activities:
Acquisition of ICTI with note payable $ - $ - $ -
============= ========== ============
Acquisition of property under a capital lease:
Land $ - $ 112,500 $ -
Building - 1,321,566 -
------------- ---------- ------------
$ - $ 1,434,066 $ -
============= ========== ============
Capital Lease Termination
Reduction of capital lease obligation $ - $ - $ -
============= ========== ============
Reduction of property
Construction in progress $ - $ - $ -
Land - - -
------------- ----------- -------------
$ - $ - $ -
============= =========== ==============
Conversion of preferred stock for common stock $ - $ 5,580,168 $ -
============= ============= ============
Preferred stock dividend paid in common stock $ - $ 121,825 $ -
============= ============= ============
Constructive dividend on convertible preferred stock $ 1,821,632 $ 1,883,333 $ -
============= ============= ============
Conversion of debentures for common stock $10,655,659 $ 4,000,000 $ 31,845,000
============= ============= ============
Conversion of stock subscriptions for common stock $ 9,900,000 $ - $ -
============= ============= ============
Preferred stock issued in payment of long term debt $ 2,000,000 $ - $ -
============= ============= ============
Acquisition of marketing rights for note payable $ 5,715,000 $ - $ -
============= ============= ============
The accompanying notes are an integral part of these statements.
BICO, Inc. and Subsidiaries
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
December 31, 2001, 2000 and 1999
NOTE A - ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING
POLICIES
1. Organization
BICO, Inc. (the Company) and its subsidiaries are engaged in
the development, manufacturing and marketing of biomedical
products and biological remediation products. In June 2000,
the Company changed its name from Biocontrol Technology, Inc.
to BICO, Inc.
2. Principles of Consolidation
The consolidated financial statements include the accounts
of: Diasense, Inc., a 52% owned subsidiary as of December 31,
2001 and 2000; Petrol Rem, Inc., a 75% owned subsidiary as of
December 31, 2001 and 2000; ViaCirq, Inc. (formerly IDT,
Inc.), a 99% owned subsidiary as of December 31, 2001 and
2000; ViaTherm, Inc., a 99% owned subsidiary as of December
31, 2001; Ceramic Coatings Technologies, Inc., a 98% owned
subsidiary as of December 31, 2001 and 2000 and B-A-
Champ.com, Inc., a 99.8% owned subsidiary as of December 31,
2001 and a 51% owned subsidiary as of December 31, 2000.
Also included in the consolidated financial statements are
the accounts of the following subsidiaries which are
inactive: International Chemical Technologies, Inc., a 58.4%
owned subsidiary as of December 31, 2001 and 2000 and
Barnacle Ban Corporation, a 100% owned subsidiary as of
December 31, 2001 and 2000. All significant intercompany
accounts and transactions have been eliminated. Subsidiary
losses in excess of the unrelated investors' interest are
charged against the Company's interest. Changes in the
Company's proportionate share of subsidiary equity resulting
from the additional equity raised by the subsidiary are
accounted for as equity transactions in consolidation with no
gain recognition due to the development stage of the
subsidiaries and uncertainty regarding the subsidiary's
ability to continue as a going concern.
Some of our consolidated subsidiaries also include
consolidated subsidiaries of their own. Petrol Rem, Inc.
consolidated financial statements include the accounts of
INTCO, Inc., a 51% owned subsidiary as of December 31, 2001
and 2000; and Tireless, Inc., a 51% owned subsidiary as of
December 31, 2001 and 2000. B-A-Champ.com, Inc. consolidated
financial statements include the accounts of TruePoints.com,
Inc., a 100% owned subsidiary as of December 31, 2001 and
2000.
3. Cash and Cash Equivalents
For purposes of the statement of cash flows, the Company
considers all highly liquid investments with a maturity of
three months or less at acquisition to be cash equivalents.
Included in cash and equivalents is a $50,000 certificate of
deposit which is pledged as collateral to secure the
Company's corporate credit cards.
4. Inventory
Inventory is valued at the lower of cost (first-in, first-out
method) or market. An inventory valuation allowance is
provided against finished goods and raw materials for
products for which a market has not yet been established.
5. Property and Equipment
Property and equipment are recorded at cost and are
depreciated over their estimated useful lives, ranging from 3
to 39 years, on a straight-line basis. Amortization of
assets recorded under capital leases is included with
depreciation expense. Impairment losses are recognized when
management determines that operating conditions raise doubts
about the ability to recover the carrying value of particular
assets. The amount of impairment loss is determined by
comparing the present value of the estimated future cash
inflows of such assets to their net carrying value.
6. Goodwill
Goodwill, which represents the excess cost of purchased
companies over the fair value of their net assets at dates of
acquisition, is amortized on a straight-line basis over five
years. Goodwill associated with assets determined to be
impaired is correspondingly written down. With the Company's
implementation of newly issued accounting standards effective
January 1, 2002, goodwill will no longer be amortized. See
Note A, number 20 below.
7. Investment in Unconsolidated Subsidiaries
During 2000 and 2001, the Company made investments in
unconsolidated subsidiaries (see Note G). These investments
are being reported on the equity basis due to the Company's
ownership percentage, options to purchase additional shares
and membership on the boards of directors of each
unconsolidated subsidiary as discussed in Note G. The
difference between the amount invested and the underlying
equity in the unconsolidated subsidiary's net assets is being
amortized as goodwill over a 5-year period. With the
Company's implementation of newly issued accounting standards
effective January 1, 2002, goodwill will no longer be
amortized. See Note A, number 20 below.
8. Loss Per Common Share
Net loss per common share is based upon the weighted average
number of common shares outstanding. The loss per share does
not include common stock equivalents since the effect would
be antidilutive. The weighted average shares used to
calculate the loss per share amounted to 1,952,313,675 in
2001, 1,037,254,759 in 2000 and 695,400,191 in 1999. The net
losses attributable to common shareholders for the years
ended December 31, 2001, 2000 and 1999 were $32,763,942,
$44,429,636 and $38,072,578, respectively, which include
constructive dividends to preferred stockholders of
$1,821,632, $1,883,333 and $0, respectively.
9. Research and Development Costs
Research and development costs are charged to operations as
incurred. Machinery, equipment and other capital
expenditures, which have alternative future use beyond
specific research and development activities, are capitalized
and depreciated over their estimated useful lives.
10. Income Taxes
The Company previously adopted Statement of Financial
Accounting Standards No. 109 (FAS 109), Accounting for Income
Taxes, which requires the asset and liability method of
accounting for income taxes. Enacted statutory tax rates are
applied to temporary differences arising from the differences
in financial statement carrying amounts and the tax bases of
existing assets and liabilities. Due to the uncertainty of the
realization of income tax benefits (Note M), the adoption of
FAS 109 had no effect on the financial statements of the
Company.
11. Interest
No interest was capitalized as a component of the cost of
property, plant and equipment constructed for its own use
during the years ended December 31, 2001, 2000 or 1999.
12. Estimates and Assumptions
The preparation of financial statements in conformity with
generally accepted accounting principles requires management
to make estimates and assumptions that affect the reported
amounts of assets and liabilities and disclosure of contingent
assets and liabilities at the date of the financial statements
and the reported amounts of revenues and expenses during the
reporting period. Actual results could differ from those
estimates. The Company has established allowances based upon
management's evaluation of inventories, accounts receivable,
and receivables from related parties and amortizes intangible
assets such as goodwill and patents over estimated useful
lives.
13. Common Stock Warrants
The Company recognizes cost on warrants granted or extended
based upon the minimum value method. Under this method, the
warrants are valued by reducing the current market price of
the underlying shares by the present value of the exercise
price discounted, at an estimated risk-free interest rate of
5% and assuming no dividends. The value of warrants is
recalculated when warrants are extended and any increase in
value over the value recorded at the time the warrant was
granted is recognized at the time the warrant is extended.
14. Debt Issue Costs
The Company follows the policy of expensing debt issue costs
on debentures when debentures are issued. Total debt issue
costs incurred for the periods ended December 31, 2001, 2000
and 1999 were $2,218,066, $1,005,000 and $3,458,300,
respectively.
15. Concentration of Credit Risk
Financial instruments, which potentially subject the Company
to significant concentrations of credit risk, consist
principally of cash investments at commercial banks,
receivables from officers and directors of the Company,
investments in unconsolidated subsidiaries and accounts
receivable from two customers, which represent over 90% of
consolidated accounts receivable. Cash and cash equivalents
are temporarily invested in interest bearing accounts in
financial institutions, and such investments may be in excess
of the FDIC insurance limit. Receivables from directors and
officers of the Company (Notes C and O) are unsecured and
represent a concentration of credit risk due to the common
employment and financial dependency of these individuals on
the Company. The company has reviewed the creditworthiness of
its significant customers and does not expect to incur a
significant loss for uncollected accounts.
16. Comprehensive Income
The Company's consolidated net income (loss) is the same as
comprehensive income to be disclosed under Statement of
Financial Accounting Standards No. 130.
17. Beneficial Convertible Debt Feature
Beneficial conversion terms included in the Company's
convertible debentures are recognized as expense and credited
to additional paid in capital at the time the associated
debentures are issued.
18. Beneficial Conversion Feature of Preferred Stock
The Company's 4% convertible preferred stock includes a
beneficial conversion feature providing the preferred
stockholder a discount upon conversion to the Company's
common stock after a specified number of days. The value of
this beneficial conversion feature is determined by reducing
the market price of the Company's common stock by the
discounted conversion price on the date of commitment. This
discount is recognized as a discount assigned to beneficial
conversion feature and is amortized as constructive dividends
to the preferred stockholders over the period prior to
conversion using the effective interest method.
19. Advertising Costs
Advertising costs are charged to operations when incurred.
Advertising expenses for 2001, 2000 and 1999 were $367,867,
$208,617 and $4,851, respectively.
20. Impact of Recently Issued Accounting Standards
In June 2001, the Financial Accounting Standards Board
("FASB") issued Statement of Financial Accounting Standards
No. 141, "Business Combinations." SFAS 141 supersedes APB
Opinion No. 16 and FASB Statement No. 38 and requires that
all business combinations be accounted for using the purchase
method. The provisions of this statement apply to all
business combinations initiated after June 30, 2001. The
Company is in the process of assessing the impact of this
pronouncement on its financial statements.
Also in June 2001, the FASB issued Statement of Financial
Accounting Standards No. 142, "Goodwill and Other Intangible
Assets." SFAS 142 supersedes APB Opinion No. 17 and
addresses financial accounting and reporting for acquired
goodwill and other intangible assets. Under this provision,
goodwill and certain intangible assets will no longer be
amortized. These assets will be evaluated on a periodic
basis to determine if an impairment loss needs to be
recorded. The provisions of this statement will be effective
for the Company's fiscal year ending December 31, 2002. The
Company is in the process of assessing the impact of this
pronouncement on its financial statements.
NOTE B - OPERATIONS AND LIQUIDITY
The Company and its subsidiaries have incurred substantial
losses in 2001 and in prior years and have funded their
operations and product development through the sale of common
and preferred stock and issuance of debt instruments. Until
such time that products can be successfully developed and
marketed, the Company and its subsidiaries will continue to
need to fulfill working capital requirements through the sale
of stock and issuance of debt. The inability of the Company
to continue its operations as a going concern would impact
the recoverability and classification of recorded asset
amounts.
The ability of the Company to continue in existence is
dependent on its having sufficient financial resources to
complete the research and development necessary to
successfully bring products to market and for marketplace
acceptance. As a result of its significant losses, negative
cash flows from operations and significant accumulated
deficits for each of the periods ending December 31, 2001,
2000, and 1999, there is substantial doubt about the
Company's ability to continue as a going concern.
In order to meet its projected expenditures for 2002,
Management believes that additional funds will need to be
raised from sales of stock and future debt issuance. As
discussed in NOTE S, Management secured commitments to
provide such funding during the first quarter of 2002.
Management believes that these financing commitments along
with a plan to reduce operating expenses, to curtail
investment activities and to dispose of certain subsidiaries
(Note S) will provide the opportunity for the Company to
continue as a going concern.
NOTE C - NOTES RECEIVABLE
Notes receivable due from various related and unrelated
parties consisted of:
Dec. 31, 2001 Dec. 31, 2000
Related Parties
Note receivable from Allegheny
Food Services, Inc. of which
Joseph Kondisko, a former
director, is principal owner,
payable in monthly installments $ 24,394 $ 87,706
of $3,630, including interest at
9.25%. The balance is due and
payable at December 31, 2001.
Note Receivable from Anthony J.
DelVicario, a former director of
Diasense, Inc. and president of
American Inter-Metallics, Inc.,
dated November 9, 2001 in the
amount of $114,000 payable on 114,000 -
demand with interest at prime
rate plus 2%. The note is
collateralized by the assets of
American Inter-Metallics, Inc.
Note receivable from Fred E.
Cooper, Chief Executive Officer,
dated April 28, 1999, in the
amount of $777,400, payable in
monthly installments of $9,427 671,338 715,693
with a final balloon payment on
May 31, 2002. Interest is
accrued at a rate of 8% per
annum.
Note receivable from Glenn
Keeling, Director, dated April
28, 1999, in the amount of
$296,358, payable in monthly
installments of $4,184 with a 146,332 237,737
final balloon payment on May 1,
2002. Interest is accrued at a
rate of 8% per annum.
Note Receivable from T.J. Feola,
Director, dated April 28, 1999,
in the amount of $259,477,
payable in monthly installments
of $3,676 with a final balloon 195,623 221,308
payment on May 31, 2002.
Interest is accrued at a rate of
8% per annum.
Demand note receivable from
Joseph A. Resnick, an employee, 23,000 -
payable upon demand with 8.75%
interest.
Unrelated Parties
Demand note receivable from
Practical Environmental
Solutions, Inc. on a $3,150,000
line of credit agreement.
Principal plus interest accrued
at a rate of 10% per annum is
payable upon demand on or before
May 31, 2002. The loan is
collateralized by a security
interest and lien on all of
Practical Environmental
Solutions' assets including its
rights to any and all contracts,
options or claims of that company
to purchase or acquire the assets 3,148,404 1,914,363
of any environmental company.
The note is classified as a
noncurrent asset as of December
31, 2001 because the management
of Petrol Rem is considering
converting all or part of this
note into a controlling equity
interest in Practical
Environmental Solutions with the
balance of the note being
converted to a term loan.
Note receivable from an
individual, due on November 15,
2002 with interest at prime plus 111,041 200,000
2% (6.75% at December 31, 2001).
Note receivable from an
individual, payable upon - 12,000
demand with 8.75% interest.
---------- -----------
4,434,132 3,388,807
Less current notes receivable 138,394 2,014,069
---------- -----------
Noncurrent $4,295,738 $ 1,374,738
========== ===========
Accrued interest receivable on the related party notes as of
December 31, 2001and 2000 was $16,092 and $13,463,
respectively.
Due to the financial dependency of the above officers and
directors on the Company, an allowance of $1,050,699 and
$1,188,201 has been provided as of December 31, 2001 and
2000, respectively.
In April 2001, the Company loaned $70,000 to Pascal M.
Nardelli, President and Chief Executive Officer of Petrol
Rem, Inc. In August 2001, this demand note and accrued
interest of $2,110 were paid in full.
NOTE D - INVENTORY
Inventories consisted of the following as of:
Dec. 31, 2001 Dec. 31, 2000
Raw materials $ 543,354 $ 2,699,527
Work in Process 341,226 512,526
Finished goods 2,111,439 1,087,093
--------- ---------
2,996,019 4,299,146
Less valuation (1,805,223) (3,493,922)
allowance --------- ---------
$1,190,796 $ 805,224
========= =========
NOTE E - PREPAID EXPENSES
Prepaid expenses consisted of the following as of:
Dec. 31, 2001 Dec. 31, 2000
Prepaid insurance $ 330,761 $ 304,229
Prepaid professional fees 612,813 234,961
Prepaid debt issue costs - 220,000
Employee advances 47,297 32,549
Prepaid taxes 22,642 31,200
Security deposits 4,428 14,799
Other prepaid expenses 37,960 150,616
---------- ---------
$1,055,901 $ 988,354
========== =========
NOTE F - INTANGIBLE ASSETS
In June 2001, the Company entered into a marketing agreement with
GAIFAR, a German company that owned all the rights to certain
rapid HIV tests, and Dr. Heinrich Repke, the man who developed
the tests. The marketing rights were assigned to Rapid HIV
Detection Corp, of which the Company owns 75% and GAIFAR owns
25%. GAIFAR retained the manufacturing rights for the tests.
The agreement, as amended, provided for a due diligence period
until October 15, 2001 and approval by the Company's board of
directors. In October 2001, the due diligence period was
completed and the Company's board provided their unanimous
resolution, making the marketing agreement fully effective. The
marketing agreement has a minimum ten-year term and calls for
total payments of $7,000,000 through the third quarter of 2002.
The entire $7,000,000 was recorded as an intangible asset with a
corresponding amount payable to GAIFAR. When the marketing
agreement became effective in October 2001, $1,025,000 previously
loaned to GAIFAR was applied to the $7 million owed to GAIFAR for
the marketing rights. The original agreement called for a loan
of $500,000 to the owner of the rapid HIV tests and technology,
but the Company agreed to loan another $125,000 during the second
quarter while the due diligence was continuing. During the third
quarter, the Company loaned an additional $400,000 while the due
diligence was completed. These payments to GAIFAR totaling
$1,025,000 were made part of the consideration paid to acquire
the exclusive worldwide marketing rights to the rapid HIV tests
and technology and are now part of the Company's investment in
Rapid HIV Detection Corp. An additional $260,000 was paid to
GAIFAR during the fourth quarter of 2001 reducing the amount
due to GAIFAR to $5,715,000, which is included in the current
portion of long-term debt (note K). The remaining payments are due
in monthly amounts ranging from $125,000 to $1,000,000 through
August 20, 2002. The marketing rights are being amortized as an
intangible asset over the ten-year minimum term of the marketing
agreement. Amortization of $133,602 was recognized during 2001.
NOTE G - INVESTMENT IN UNCONSOLIDATED SUBSIDIARIES
During the year ended December 31, 2001, the Company invested
an additional $10,000 in Insight Data Link.com, Inc. (IDL),
an unconsolidated subsidiary interest initially acquired in
2000. With this additional investment, the Company has
invested $110,000 in IDL and its ownership percentage is
approximately 27%. Insight is a Pennsylvania corporation
formed to engage in the business of acting as an internet
clearinghouse for persons seeking to acquire, and persons
having available, shopping mall space, as well as software
development for related projects.
Also during the year ended December 31, 2001 the Company
invested an additional $190,000 in American Inter-Metallics,
Inc. ("AIM") an unconsolidated subsidiary interest initially
acquired during 1999. With this additional investment, the
Company owns 20% of AIM. AIM has its operations in Rhode
Island, and is developing a product that enhances performance
in rockets and other machinery by increasing the burn rate of
propellants.
During the year ended December 31, 2001, Diasense invested an
additional $600,000 in Microislet, Inc., an unconsolidated
subsidiary interest initially acquired during 2000. With
this additional investment, Diasense has invested $1,600,000
in Microislet and its ownership is approximately 20.2%.
Diasense holds a seat on the board of directors of this
unconsolidated subsidiary. MicroIslet is a California
company, which has licensed several diabetes research
technologies from Duke University with a specific focus on
optimizing microencapsulated islets for transplantation.
Also during the year ended December 31, 2001, Diasense
invested an additional $293,948 in Diabecore Medical, Inc.,
an unconsolidated subsidiary interest initially acquired
during 2000. With this additional investment, Diasense has
invested $987,468 in Diabecore and owns approximately 24% of
this unconsolidated subsidiary. Diasense holds a seat on the
board of directors of Diabecore. Diabecore is a Toronto-
based company working to develop a new insulin for the
treatment of diabetes.
These investments are being reported on the equity basis and
differences between the investment and the underlying net
assets of the unconsolidated subsidiaries are being amortized
as goodwill over a 5-year period.
The Company's investment in the underlying assets and the
unamortized goodwill of each unconsolidated subsidiary as of
December 31, 2001 and December 31, 2000 are as follows:
Investment in
Unconsolidated Underlying Net Unamortized
Subsidiary Assets Goodwill Total
2001 2000 2001 2000 2001 2000
American Inter-
Metallics, Inc. $ 318,200 $222,912 $ 394,300 $441,004 $ 712,500 $ 663,916
Insight Data Link.com 22,876 28,503 41,629 52,546 64,505 81,049
MicroIslet, Inc. 130,477 50,731 786,874 688,508 917,351 739,239
Diabecore Medical,Inc 158,935 50,615 556,552 526,620 715,487 577,235
_________ ________ _________ _________ __________ ________
Total $ 630,488 $352,761 $1,779,355$1,708,678$2,409,843 $2,061,439
========= ======== ========= ========= ========== =========
The amounts recognized as amortization of goodwill and loss on
unconsolidated subsidiaries for each investment for the years ended
December 31, 2001 and 2000 are as follows:
Loss
Unconsolidated Amortization on
Subsidiary of Goodwill Unconsolidated
Subsidiaries
2001 2000 2001 2000
American Inter-
Metallics, Inc. $ 141,416 $106,369 $ - $ -
Insight Data 13,770 13,136 (12,774) (5,815)
Link.com
MicroIslet, Inc. 188,525 152,628 (233,363) (108,133)
Diabecore Medical, Inc. 121,855 72,049 (33,841) (44,235)
--------- ------- --------- --------
Total $ 465,566 $344,182 $(279,978) $(158,183)
========= ======= ========= ========
NOTE H- BUSINESS SEGMENTS
The Company operates in two reportable business segments:
Biomedical devices, which includes the operations of BICO, Inc.,
Diasense, Inc. and ViaCirQ, Inc. and Bioremediation, which
includes the operations of Petrol Rem, Inc. Following is
summarized financial information for the Company's reportable
segments:
Biomedical
2001 Devices Bioremedication All Other Consolidated
Sales to external customers $ 817,353 $3,383,637 $ 141,213 $ 4,342,203
Cost of products sold 558,408 2,507,717 221,051 3,287,176
Gross profit (loss) 258,945 875,920 (79,838) 1,055,027
Identifiable assets 17,414,784 6,515,188 642,095 24,572,067
Capital expenditures 930,012 512,887 99,139 1,542,038
Depreciation and amortization 1,302,037 350,688 56,355 1,709,080
Interest Income 259,928 301,889 0 561,817
Interest Expense 737,972 11,329 77,045 826,346
Biomedical
2000 Devices Bioremedication All Other Consolidated
Sales to external customers $ 81,954 $ 217,722 $ 40,651 $ 340,327
Cost of products sold 47,862 179,446 127,203 354,511
Gross profit (loss) 34,092 38,276 (86,552) (14,184)
Identifiable assets 16,628,619 4,385,100 835,589 21,849,308
Capital expenditures 2,788,454 0 34,120 2,822,574
Depreciation and amortization 979,083 74,120 43,198 1,096,401
Interest Income 543,457 46,072 0 589,529
Interest Expense 1,811,665 0 113,208 1,924,873
1999
Sales to external customers $ 82,056 $ 26,693 $ 3,599 $ 112,348
Cost of products sold 133,288 14,683 0 147,971
Gross profit(loss) (51,232) 12,010 3,599 (35,623)
Identifiable asset 15,018,258 226,760 440,818 15,685,836
Capital expenditures 262,954 0 378,417 641,371
Depreciation and amortization 5,108,855 34,351 96,060 5,239,266
Interest Income 1,031,560 0 0 1,031,560
Interest Expense 1,373,404 0 0 1,373,404
NOTE I - ACCRUED LIABILITIES
Accrued liabilities consisted of the following as of:
Dec. 31, 2001 Dec. 31, 2000
Accrued interest $ 176,080 $ 1,120,655
Accrued payroll 1,488,748 373,821
Accrued payroll taxes and 14,815 24,303
withholdings
Accrued vacation 65,446 66,445
Accrued class action 425,000 1,300,000
settlement (note O)
Deferred revenue 173,516 21,633
Accrued income taxes 140,827 43,780
Other accrued liabilities 84,094 181,128
----------- ----------
$ 2,568,526 $ 3,131,765
=========== ==========
NOTE J - DEBT OBLIGATIONS
Notes payable consisted of the following as of:
Dec. 31, Dec. 31,
2001 2000
Note Payable in connection with a Settlement
Agreement and Mutual Release related to the
outstanding amounts owed for the Company's
stock purchase agreement for 58.4% interest
in International Chemical Technologies, Inc. 500,000 -
(ICTI). The note bears interest at a rate
of 10% per annum and is payable in ten
monthly installments from January to October
2002.
Commercial Premium Finance Agreement of
Intco, Inc., a 51% owned subsidiary of the
Company's subsidiary, Petrol Rem, Inc.
Amounts are payable in nine monthly - 66,210
installments of $11,342 including interest
at 9.47% per annum beginning October 1,
2000.
Commercial Premium Finance Agreement of
Intco, Inc., a 51% owned subsidiary of the
Company's subsidiary, Petrol Rem, Inc.
Amounts are payable in nine monthly 79,016 -
installments of $13,534 including interest
at 9.45% per annum beginning October 1,
2001.
Note Payable by the Company's subsidiary,
Petrol Rem, Inc., in connection with the
stock purchase agreement for 51% interest in
Intco, Inc. The note is payable without
interest in installments as follows: (i) on - 850,000
the first day of each calendar month from
January 1, 2001 through and including April
1, 2001, a principal payment of $150,000 and
(ii) $250,000 on May 1, 2001.
Promissory Note payable to the minority
owner of Intco, Inc., a 51% owned subsidiary
of the Company's subsidiary, Petrol Rem,
Inc. The loan is collateralized by Petrol 500,000 -
Rem's 51% ownership in Intco. Principal and
interest at 7% per annum are payable upon
demand
Note Payable in connection with the purchase
of marketing rights for certain rapid HIV
tests. The note is payable in various 5,715,000 -
monthly installments ranging from $125,000
to $1,000,000 per month through August 2002
Commercial Premium Finance Agreement payable
in nine monthly installments of $11,492 89,187 -
including interest at 8.15% per annum
beginning December 9, 2001.
Commercial Premium Finance Agreement payable
in nine monthly installments of $15,878 108,630 -
including interest at 6.9% per annum
beginning November 1, 2001.
Commercial Premium Finance Agreement payable
in eight monthly installments of $13,208 - 77,317
including interest at 8.5% per annum
beginning December 1, 2000.
Commercial Premium Finance Agreement payable
in nine monthly installments of $9,903 - 75,600
including interest at 12.63% per annum
beginning December 10, 2000.
$50,000 line of credit with PNC Bank. The
outstanding balance bears interest at a
rate of 6.75% per annum. 45,365 -
---------- --------
Note payable $7,037,198 $1,069,127
========== =========
During the year ended December 31, 2001, the Company issued
promissory notes totaling $11,715,000. As of December 31, 2001, all
of these promissory notes totaling $11,715,000 had been repaid with
proceeds from the sale of common stock subscriptions and preferred
stock.
Long-term debt consisted of the following as of:
Dec. 31, Dec. 31,
2001 2000
Note Payable in connection with stock
purchase agreement for 58.4% interest in
International Chemical Technologies, Inc.
(ICTI). The note bears interest at a rate
of 10% per annum and is collateralized by
the shares of ICTI purchased in the
transaction. At December 31, 2000, the $ - $ 2,900,000
Company was in default on the terms of this
loan and the note holder had made demand for
payment. Accordingly, the unpaid balance
was classified as due and payable. In 2001,
the Company finalized an agreement for
payment of this note.
Note Payable by the Company's subsidiary,
International Chemical Technologies, Inc.
(ICTI), to it's former shareholder. The
loan bears interest at a rate of 9.5% per
annum and is guaranteed by the Company and
collateralized by all tangible and
intangible assets of ICTI, and assignment of
ICTI's interest in its lease for its - 1,191,667
production facilities. At December 31,
2000, the Company was in default on the
terms of this loan and the note holder had
made demand for payment. Accordingly, the
unpaid balance was classified as due and
payable. In 2001, the Company finalized an
agreement for payment of this note See
further discussion of this agreement later
in this note.
Promissory Note of Intco, Inc., a 51% owned
subsidiary of the Company's subsidiary,
Petrol Rem, Inc. The loan is collateralized
by certain Intco equipment.
Principal and interest at 9.5% per annum are 3,503 20,351
payable in 25 equal monthly installments of
$1,500 each commencing February 27, 2000
with a final payment of all remaining
principal and interest due on March 27,
2002.
Promissory Note of Intco, Inc., a 51% owned
subsidiary of the Company's subsidiary,
Petrol Rem, Inc. The loan is collateralized
by certain Intco equipment.
Principal and interest at 9% per annum are
payable on demand or, if no demand is made, 3,602 7,263
in 35 equal monthly installments of $320
each commencing February 25, 2000 with a
final payment of all remaining principal and
interest due on February 25, 2003.
Promissory Note of Intco, Inc., a 51% owned
subsidiary of the Company's subsidiary,
Petrol Rem, Inc. The loan is collateralized
by certain Intco equipment.
Principal and interest at 7.75% per annum
are payable on demand or, if no demand is 12,285 -
made, in 47 equal monthly installments of
$325 each commencing October 10, 2001 with a
final payment of all remaining principal and
interest due on September 10, 2005.
Term Loan of Tireless, Inc., a 51% owned
subsidiary of the Company's subsidiary,
Petrol Rem, Inc. The loan is collateralized
by certain Tireless assets. 194,444 -
Principal and interest at prime rate plus
2.5% per annum are payable in 36 monthly
installments of $5,556 each plus interest
commencing December 1, 2001.
Note Payable to a bank in monthly payments
of $433 including interest at 8.75% per 363 2,239
annum. The loan in collateralized by
equipment. ---------- ----------
214,197 4,121,520
Current portion of long-term debt 86,420 4,113,656
---------- ----------
Long-term debt $ 127,777 $ 7,864
========== ==========
As of December 31, 2001, the Company's current portion of
long-term debt included $4,091,667 due in connection with
debt incurred when ICTI was purchased. In addition,
$1,084,277 was accrued for interest related to the ICTI debt.
In the fourth quarter, the Company finalized an agreement to
make payments of $725,000, issue 4,000 shares of convertible
preferred stock valued at $2,000,000, issue 50,000 shares of
the common stock of the Company's subsidiary, ViaCirq, valued
at $150,000 and issue 25,000 shares of the common stock of
the Company's subsidiary, Petrol Rem, valued at $12,500 as
settlement for the amounts due. As a result of this
agreement, the Company recognized $2,562,848 in debt
forgiveness in the fourth quarter.
NOTE K - LEASES
Operating Leases
Until October 2000, the Company was committed under a non-
cancelable operating lease for its research and product
development facility. The lease between the Company and a
group of investors (lessor), which included four of the
Company's Executive Officers and/or Directors, was for a
period of 240 months beginning September 1, 1990. Monthly
rental under the terms of the lease was $8,810 for a period
of 119 months to August 1, 2000. In October 2000, after the
Company's research and development operations had been moved
from the facility, the building was sold by the investor
group and the lease was terminated. Total rent expense for
this facility was $0, $70,480 and $105,720 in 2001, 2000 and
1999, respectively.
The Company and its related subsidiaries also lease other
office facilities, various equipment and automobiles under
operating leases expiring in various years through 2005.
Total lease expense related to these leases was $598,981,
$534,235, and $425,654 in the years ended December 31, 2001,
2000 and 1999, respectively.
Capital Leases
During 1996, the Company leased two manufacturing buildings
under capital leases expiring in various years through 2011.
The assets and liabilities under capital leases are recorded
at the lower of the present value of the minimum lease
payments or the fair value of the asset. The assets are
depreciated over the lower of their related lease terms or
their estimated productive lives. Depreciation of assets
under capital leases is included in depreciation expense.
During 1998, the Company terminated the lease of one of its
two manufacturing buildings in response to the filing of a
judgement for nonpayment under the terms of the lease. The
Company recognized a loss of $387,321 based upon the
difference between the remaining lease obligation and the
property relinquished.
In July 2000, the Company entered into a new capital lease
replacing the lease on its manufacturing facility terminated
in 1998. Under the terms of the lease, the Company will make
total payments of $1,602,221 through December 2010, at which
time title to the property will be transferred to the
Company. Management recognized this property and the
corresponding capital lease obligation at the present value
of the lease payments, which was $1,434,066 at the inception
of the lease, using an imputed rate of 9% per annum.
The following is a summary of property held under capital leases:
Dec. 31, 2001 Dec. 31, 2000
Buildings $ 2,527,326 $ 2,527,326
Land 246,250 246,250
Equipment 264,490 264,490
---------- ------------
Sub Total 3,038,066 3,038,066
Less: Accumulated Depreciation 680,776 529,286
---------- ------------
Total Property under
Capital Leases $ 2,357,290 $ 2,508,780
========== ============
Minimum future lease payments under capital leases and
noncancelable operating leases are as follows:
Capital Operating Leases
Leases
2002 $ 336,562 $ 322,476
2003 333,654 251,661
2004 338,413 72,068
2005 352,066 16,500
2006 357,115 -
Thereafter 1,748,054 -
--------- ---------
Total minimum lease payments 3,465,864 $ 662,705
=========
Less amounts representing 1,262,192
interest ---------
Present value of net minimum
lease payments $2,203,672
=========
NOTE L- SUBORDINATED CONVERTIBLE DEBENTURES
During 2001 the Company issued subordinated 4% convertible
debentures totaling $8,255,659. Such convertible debentures
were issued pursuant to Regulation D, and/or Section 4(2) and
have a one-year mandatory maturity and are not saleable or
convertible for a minimum of 90 days from issuance. A
$2,063,915 expense was recognized upon issuance for the
beneficial conversion feature of these debentures. As of
December 31, 2001, all of the debentures totaling $10,655,659
were converted into 297,516,852 shares of common stock.
During 2000 and 1999, the Company issued subordinated 4%
convertible debentures totaling $12,250,000 and $33,150,000,
respectively. Such convertible debentures were issued
pursuant to Regulation S, Regulation D, and/or Section 4(2)
and had a one-year mandatory maturity and were not saleable
or convertible for a minimum of 45 to 90 days from issuance.
At December 31, 2000 and 1999, the subordinated convertible
debentures totaled $2,400,000 and $0, respectively. The
debentures issued in 1999 and 2000 included beneficial
conversion features providing a discount on the acquisition
of common stock at discounts ranging from 12% to 22%.
NOTE M- STOCKHOLDERS' EQUITY
Preferred Stock
The Board of Directors of the Company may issue up to 500,000
shares of preferred stock in series, which would have rights
as determined by the Board.
During 1999, 400,000 shares of the preferred stock were
authorized as "4% Cumulative Convertible Preferred Stock,
Series F". 72,000 shares of this preferred stock were issued
in 1999 and 452,000 shares were issued in 2000 and these
shares include a beneficial conversion feature providing the
preferred stockholder a discount of 25% upon conversion to
the Company's common stock after 120 days. The total value
of this beneficial conversion feature was $1,883,333 and was
recognized as constructive dividends charged to additional
paid in capital during the year ended December 31, 2000.
During 2000, all shares of preferred stock were converted to
common stock. In addition, a preferred stock dividend of
$121,825 was distributed to preferred shareholders upon
conversion.
During 2001, shares of preferred stock were authorized as "4%
Cumulative Convertible Preferred Stock" in the following
series and with the following features:
Issued Number of Days
Shares at until
Series Authorized Dec. 31, Conversion Conversion to
Shares 2001 Discount Common Stock
G 100,000 10,530 24% 60
H 246,000 2,000 20% 75
I 4,000 4,000 0% 0
J 50,000 400 20% 30
Series G, H and J include a beneficial conversion feature
providing the preferred shareholder a discount upon
conversion to the Company's common stock after a specified
number of days. The value of this beneficial conversion
feature is determined by reducing the market price of the
Company's common stock by the discounted conversion price on
the date of commitment. This discount is recognized as a
discount assigned to the beneficial conversion feature of
preferred stock and is amortized as constructive dividends to
the preferred shareholders over the holding period using the
effective interest method. The total valuation discount of
this beneficial conversion feature on the preferred stock
outstanding at December 31, 2001 was $1,962,632. Total
amortization recognized as constructive dividends that were
charged to Additional Paid in Capital in the year ended
December 31, 2001 was $1,821,632.
Common Stock
In December 2001, we filed a Form S-8 that included 125
million shares. The Form S-8 allows us to issue freely
tradable stock to non-executive employees under our Equity
Compensation Plan and to certain consultants in lieu of
paying them in cash.
Common Stock Warrants
During 2001, warrants ranging from $.015 to $.102 per share
to purchase 65,641,400 shares of common stock were granted at
exercise prices that were equal to or above the current
quoted market price of the stock on the date issued. In
2000, warrants to purchase 5,941,998 shares were granted at
exercise prices ranging from $.07 to $.25 per share. In
connection with the granting of warrants, the Company
recognized $17,420 and $324,897 of general and administrative
expense in 2001 and 2000 respectively. Warrants to purchase
96,136,560 shares of common stock were exercisable at
December 31, 2001. The per share exercise prices of these
warrants are as follows:
Shares Exercise
Price
30,000 $.0150
36,400 $.0156
60,000 $.0208
60,000 $.0212
60,000 $.0301
60,000 $.0372
85,000 $.0382
12,550,000 $.0500
52,000,000 $.0525
20,000 $.0600
160,000 $.0700
500,000 $.0730
35,000 $.0800
1,700,000 $.1000
200,000 $.1020
85,000 $.1030
1,000,000 $.1250
19,910,500 $.1290
1,110,200 $.1300
600,000 $.1400
400,000 $.1440
125,000 $.1550
236,798 $.1600
10,000 $.2200
2,326,700 $.2500
80,000 $.3300
50,000 $.3800
1,482 $.4500
350,000 $.5000
884,000 $1.0000
150,000 $1.4800
1,025,000 $2.0000
71,000 $2.1250
69,480 $2.2500
25,000 $2.4100
20,000 $2.7500
25,000 $3.0000
25,000 $3.2000
----------
Total 96,136,560
==========
The fiscal years in which common stock warrants were granted
and the various expiration dates by fiscal year are as
follows:
Fiscal Warrants Warrants Expire during Fiscal Year
Year Granted 2002 2003 2004 2005 2006
1990 406,700 0 406,700 0 0 0
1991 1,251,482 351,482 900,000 0 0 0
1992 0 0 0 0 0 0
1993 131,000 0 131,000 0 0 0
1994 130,000 20,000 85,000 25,000 0 0
1995 0 0 0 0 0 0
1996 234,480 0 175,000 59,480 0 0
1997 944,000 944,000 0 0 0 0
1998 1,420,000 0 1,420,000 0 0 0
1999 20,035,500 0 0 20,035,500 0 0
2000 5,941,998 0 0 5,941,998 0
2001 65,641,400 0 0 0 65,641,400
__________ _________ _________ __________ ___________ ___________
96,136,560 1,315,482 3,117,700 20,119,980 5,941,998 65,641,400
========== ========= ======== ========== =========== ===========
The following is a summary of the warrant transactions during
2001:
Outstanding at beginning of period 31,378,160
Granted during the twelve-month period 65,641,400
Canceled during the twelve-month period (883,000)
Exercised during the twelve-month period -
------------
Outstanding and eligible for exercise at
end of period 96,136,560
============
The following is a summary of expenses recognized in connection
with warrants granted or extended during 2001 and 2000:
2001 2000
Granted Extended Total Granted Extended Total
Parent
Company $17,420 $ - $ 17,420 $ 324,897 $ - $ 324,897
Subsidiaries:
Diasense 55,199 - 55,199 230,178 - 230,178
ViaCirQ 133,052 - 133,052 5,885,069 5,233,529 11,118,598
------- ------ ------- --------- --------- ----------
188,251 - 188,251 6,115,247 5,233,529 11,348,776
------- ------ ------- --------- --------- ----------
Total $205,671 $ - $205,671 $6,440,144 $5,233,529 $11,673,673
======= ====== ======== ========= ========= ==========
During 2001 and 2000, expenses recognized on warrants granted
are included in the Statement of Operations as general and
administrative expenses of $205,671 and $6,071,961,
respectively and research and development expenses of $0 and
$368,183, respectively.
Warrant Extensions
During 2001, the Company extended the exercise date of
warrants to purchase 1,432,700 shares of common stock to
certain officers, employees and consultants. The warrant
shares were originally granted at exercise prices ranging
from $.25 to $3.00, and were extended at the original grant
price. No expense was charged to operations since the market
price of the stock was less than the present value of the
warrant exercise price.
During 2000, the Company did not extend the exercise date of
any warrants.
During 1999, the Company extended the exercise date of
warrants to purchase 540,962 shares of common stock to
certain officers, employees and consultants. The warrant
shares were originally granted at exercise prices ranging
from $.45 to $2.75, and were extended at the original grant
price. No expense was charged to operations since the market
price of the stock was less than the present value of the
warrant exercise price.
Diasense, Inc. Common Stock
At December 31, 2001, warrants to purchase 10,635,013 shares
of Diasense, Inc. common stock were exercisable. The per
share exercise price is $.50 for 7,780,000 shares, $1.00 for
2,160,463 shares and $3.50 for 694,550 shares. The warrants
expire at various dates through 2006. To the extent that all
warrants were exercised, the Company's proportionate
ownership would be diluted from 52% at December 31, 2001 to
36%.
Diasense, Inc. Warrants
During 2001, Diasense, Inc. granted warrants to purchase
500,000 shares of its common stock and extended the exercise
date of warrants to purchase 1,205,750 shares of common stock
to certain officers, directors, employees and consultants. A
charge of $55,199 is included in general and administrative
expenses for warrants granted during 2001. The extended
warrants were originally granted at an exercise price ranging
from $0.50 to $3.50 and extended at the same price. No
expense was charged to operations since the estimated market
price of the stock was less than the present value of the
warrant exercise price.
During 2000, Diasense, Inc. granted warrants to purchase
2,075,000 shares of its common stock and extended the
exercise date of warrants to purchase 2,483,050 shares of
common stock to certain officers, directors, employees and
consultants. A charge of $230,178 is included in general and
administrative expenses for warrants granted during 2000.
The extended warrants were originally granted at an exercise
price ranging from $1.00 to $3.50 and extended at the same
price. No expense was charged to operations since the
estimated market price of the stock was less than the present
value of the warrant exercise price.
Petrol Rem, Inc. Common Stock
At December 31, 2001, warrants to purchase 6,490,000 shares
of Petrol Rem common stock were exercisable. The per share
exercise price is $.10 for 3,940,000 shares, $.50 for
2,350,000 shares and $1.00 for 200,000 shares. The warrants
expire at various dates through 2006. To the extent that all
the warrants were exercised, the Company's proportionate
ownership would be diluted from 75% at December 31, 2001 to
57%.
Petrol Rem Warrants
During 2001, Petrol Rem, Inc. granted warrants to purchase
200,000 shares of its common stock to certain officers,
directors, employees and consultants. No expense was charged
to operations since the market price of the stock was less
than the present value of the warrant exercise price. Petrol
Rem did not extend the exercise dates of any warrants during
2001.
During 2000, Petrol Rem, Inc. granted warrants to purchase
1,950,000 shares of its common stock to certain officers,
directors, employees and consultants. No expense was charged
to operations since the market price of the stock was less
than the present value of the warrant exercise price. Petrol
Rem did not extend the exercise dates of any warrants during
2000.
ViaCirq, Inc. Common Stock
At December 31, 2001, warrants to purchase 6,508,000 shares
of ViaCirq common stock were exercisable. The per share
exercise price is $.10 for 6,183,000 shares and $.50 for
20,000 shares, $1.00 for 285,000 shares, $2.00 for 5,000
shares and $3.00 for 15,000 shares. The warrants expire at
various dates through 2006. To the extent that all the
warrants were exercised, the Company's proportionate
ownership would be diluted from 99% at December 31, 2001 to
70%.
ViaCirq, Inc. Warrants
During 2001, ViaCirq, Inc. granted warrants to purchase
25,000 shares of its common stock to certain officers,
directors, employees and consultants. Charges of $133,052
are included in general and administrative expenses for the
warrants granted during 2001. ViaCirq did not extend the
exercise dates of any warrants during 2001.
During 2000, ViaCirq, Inc. granted warrants to purchase
2,128,000 shares of its common stock and extended the
exercise date of warrants to purchase 3,125,000 shares of
common stock to certain officers, directors, employees and
consultants. Charges of $5,516,886 and $368,183 are included
in general and administrative expenses and research and
development expenses, respectively, for the warrants granted
during 2000. The extended warrants were originally granted
at an exercise price ranging from $0.10 to $3.00 and extended
at the same price. ViaCirq, Inc. recorded a $5,233,529
expense for these extended warrants.
NOTE N- INCOME TAXES
As of December 31, 2001, the Company and its subsidiaries
except Diasense Inc., Petrol Rem, Rapid HIV, and ICTI, have
available approximately $157,400,000 of net operating loss
carryforwards for federal income tax purposes. These
carryforwards are available, subject to limitations, to
offset future taxable income, and expire in tax years 2002
through 2022. The Company also has research and development
credit carryforwards available to offset federal income taxes
of approximately $1,569,000, subject to limitations, expiring
in tax years 2005 through 2021.
As of September 30, 2001, the end of its fiscal year,
Diasense, Inc. had available approximately $26,700,000 of net
operating loss carryforwards for federal income tax purposes.
These carryforwards, which expire during the years 2005
through 2021, are available, subject to limitations, to
offset future taxable income. Diasense, Inc. also has
research and development credit carryforwards available for
federal income tax purposes of approximately $700,000,
subject to limitations, expiring in the years 2005 through
2012.
As of December 31, 2001, Petrol Rem had available
approximately $17,600,000 of net operating loss carryforwards
for federal income tax purposes. These carryforwards, which
expire during the years 2008 through 2022, are available,
subject to limitations, to offset future taxable income.
Petrol Rem also has research and development credit
carryforwards available for federal income tax purposes of
approximately $15,000.
As of December 31, 2001, Rapid HIV had available
approximately $480,000 of net operating loss carryforwards
for federal income tax purposes. These carryforwards, which
expire in the year 2022, are available, subject to
limitations, to offset future taxable income.
As of December 31, 2001, ICTI had available approximately
$1,435,000 of net operating loss carryforwards for federal
income tax purposes. These carryforwards, which expire
during the years 2018 through 2020, are available, subject to
limitations, to offset future taxable income.
Certain items of income and expense are recognized in
different periods for financial and income tax reporting
purposes. In the year ended December 31, 1999, a warrant
exercise adjustment of $50,625 was reported for tax purposes.
The fair market value of warrant extentions have been
recorded and expensed for financial statement purposes in the
year ended December 31, 1999 in the amount of $6,092,562 and
in the year ended December 31, 2000 of $11,118,598.
The Company has not reflected any future income tax benefits
for these temporary differences or for net operating loss and
credit carryforwards because of the uncertainty as to
realization. Accordingly, the adoption of FAS 109 had no
effect on the financial statements of the Company.
The following is a summary of the composition of the
Company's deferred tax asset and associated valuation
allowance at December 31, 2001, December 31, 2000 and
December 31, 1999:
Dec. 31, Dec. 31, Dec. 31,
2001 2000 1999
Net Operating Loss $53,516,000 $ 45,050,000 $ 37,672,000
Warrant Expense 8,593,191 8,593,191 4,812,686
Tax Credit Carryforward 1,569,000 1,775,000 1,370,000
---------- ---------- -----------
63,678,191 55,418,191 43,854,868
Valuation Allowance (63,678,191) (55,418,191) (43,854,868)
---------- ---------- -----------
Net Deferred Tax Asset $ - $ - $ -
========== ========== ===========
The following is a summary of deferred tax benefit and the
associated increase in the valuation allowance:
Increase in
Deferred Valuation
Tax Benefit Allowance Net
Year-ended December 31, 2001 $( 8,466,000) $ 8,466,000 $ 0
Year-ended December 31, 2000 $(11,357,323) $ 11,357,323 $ 0
Year-ended December 31, 1999 $(11,718,671) $ 11,718,671 $ 0
From March 20, 1972 (inception)
Through December 31, 2001 $(63,678,191) $ 63,678,191 $ 0
Intco, Inc., a subsidiary of Petrol Rem, files separate income
tax returns. At December 31, 2001, the Company has included
Intco's tax provision and related deferred and current taxes
in the accompanying financial statements as follows:
Amount Recorded As
------ -----------
Income tax provision $120,882 Other income and expense-other taxes
Deferred tax asset $ 8,115 Other assets
Deferred tax liability $ 25,009 Long-term liabilities-other
Income taxes payable $140,827 Accrued liabilities
NOTE O - RELATED PARTY TRANSACTIONS
Research and Development Activities
The Company is currently performing research and development
activities related to the non-invasive glucose sensor (the
Sensor) under a Research and Development Agreement with
Diasense, Inc. If successfully developed, the Sensor will
enable users to measure blood glucose levels without taking
blood samples. Diasense, Inc. acquired the rights to the
Sensor, including one United States patent from BICO for
$2,000,000 on November 18, 1991. Such patent covers the
process of measuring blood glucose levels non-invasively.
Approval to market the Sensor is subject to federal
regulations including the Food and Drug Administration (FDA).
The Sensor is subject to clinical testing and regulatory
approvals by the FDA. BICO is responsible for substantially
all activities in connection with the development, clinical
testing, FDA approval and manufacturing of the Sensor. As
discussed in Note B,
BICO finances its operations from the sales of stock and
issuance of debt and was reimbursed for costs incurred under
the terms and conditions of the Research and Development
Agreement for the research and development of the Sensor by
Diasense, Inc. If BICO were unable to perform under the
Research and Development or Manufacturing Agreements,
Diasense, Inc. would need to rely on other arrangements to
develop and manufacture the Sensor or perform these efforts
itself.
BICO and Diasense, Inc. have entered into a series of
agreements related to the development, manufacturing and
marketing of the Sensor. BICO is to develop the Sensor and
carry out all steps necessary to bring the Sensor to market
including 1) developing and fabricating the prototypes
necessary for clinical testing; 2) performing the clinical
investigations leading to FDA approval for marketing; 3)
submitting all applications to the FDA for marketing
approval; and 4) developing a manufacturable and marketable
product. Diasense, Inc. is to conduct the marketing of the
Sensor. The following is a brief description of the
agreements:
Manufacturing Agreement
The manufacturing agreement between BICO and Diasense, Inc.
was entered into on January 20, 1992. BICO is to act as the
exclusive manufacturer of production units of the Sensor upon
the completion of the Research and Development Agreement and
sell the units to Diasense, Inc. at a price determined by the
agreement. The term of the agreement is fifteen years.
Research and Development Agreement
Under a January 1992 agreement between BICO and Diasense,
Inc., beginning in April 1992, BICO received $100,000 per
month, plus all direct costs for the research and development
activities of the Sensor. This agreement replaced a previous
agreement dated May 14, 1991. The term of the new agreement
is fifteen years. In July 1995, BICO and Diasense, Inc.
agreed to suspend billings, accruals of amounts due and
payments pursuant to the research and development agreement
pending the FDA's review of the Sensor.
Purchase Agreement
In November 1991, BICO entered into a Purchase Agreement with
Diasense, Inc. under which Diasense, Inc. acquired BICO's
rights to the Sensor for a cash payment of $2,000,000. This
agreement permits BICO to use Sensor technology for the
manufacture and sale by BICO of a proposed implantable closed
loop system. BICO will pay Diasense, Inc. a royalty equal to
five percent of the net sales of such implantable closed loop
system.
Real Estate Activities
Four of the Company's Executives and/or Directors are members
of an eight-member partnership that in July 1990 purchased
the Company's real estate in Indiana, Pennsylvania, and each
personally guaranteed the payment of lease obligations to the
bank providing the funding. For their personal guarantees,
the four individuals each received warrants to purchase
100,000 shares of the Company's common stock at an exercise
price of $.33 per share until June 29, 1995. Those warrants
still outstanding as of the original expiration date were
extended until June 29, 2001. In 1999, after all operations
were relocated from this site, the property was offered for
sale. The property was sold in October 2000 and the lease
was terminated.
Amounts due from Officers
On April 28, 1999, Fred E. Cooper, CEO and Director,
consolidated various outstanding obligations into a term loan
totaling $777,400 payable in monthly installments of $9,427
with a final balloon payment on May 31, 2002. Interest on
this loan is accrued at a rate of 8% per annum.
Total amounts due from Mr. Cooper at December 31, 2001 and
December 31, 2000, include balances of $671,338 and $715,963,
respectively, on the term loan discussed above plus accrued
interest of $6,683 and $9,163, respectively.
On April 28, 1999, Glenn Keeling, a Director, consolidated
various outstanding obligations into a term loan totaling
$296,358 payable in monthly installments of $4,184 with a
final balloon payment on May 1, 2002. Interest on this loan
is accrued at a rate of 8% per annum.
Total amounts due from Mr. Keeling at December 31, 2001 and
December 31, 2000, include balances of $146,332 and $237,737,
respectively, on the term loan discussed above plus accrued
interest of $3,829 and $3,668, respectively.
On April 28, 1999, T.J. Feola, COO and Director, consolidated
various outstanding obligations into a term loan totaling
$259,477 payable in monthly installments of $3,676 with a
final balloon payment on May 31, 2002. Interest on this loan
is accrued at a rate of 8% per annum.
Total amounts due from Mr. Feola at December 31, 2001 and
December 31, 2000 include balances of $195,623 and $221,308,
respectively, on the term loan discussed above plus accrued
interest of $1,947 and $631, respectively.
As of December 31, 2001 and 2000 the Company had a note
receivable from Allegheny Food Services, Inc. of which Joseph
Kondisko, a former director, is principal owner. The loan,
which bears interest at a rate of 9.25%, is payable upon
demand. The outstanding balance on this loan was $24,394 at
December 31, 2001 and $87,706 at December 31, 2000.
During 1999 the Company made various demand loans totaling
$150,000 to B-A-Champ.com, Inc., a company substantially
owned by Fred E. Cooper, CEO. As of December 31, 1999, these
loans had been repaid to a balance of $50,000 with an accrued
interest of $3,006. As of December 31, 1999, the Company
owned approximately 6.5% of the outstanding stock of B-A-
Champ.com, Inc. In 2000, the Company provided additional
funding of $400,000 in exchange for additional shares of B-A-
Champ.com, Inc. In addition, the Company converted a note
receivable of $50,000 from B-A-Champ.com, Inc. plus accrued
interest of $5,256 to common stock. As a result of these
additional investments, the Company owned 51% of the
outstanding stock of B-A-Champ.com, Inc. as of December 31,
2001 and 2000 and included B-A-Champ.com, Inc. as a
consolidated subsidiary in the December 31, 2001 and 2000
financial statements. As of December 31, 2000, Fred E.
Cooper, Chief Executive Officer of the Company, owned
approximately 30% of the outstanding common stock of B-A-
Champ.com, Inc. In 2001, Mr. Cooper gave his shares of B-A-
Champ.com, Inc. to BICO. As of December 31, 2001, BICO owns
99.8% of B-A-Champ.com, Inc.
In April 2001, the Company loaned $70,000 to Pascal M.
Nardelli, President and CEO of Petrol Rem, Inc. In August
2001, this demand note and accrued interest of $2,110 were
paid in full.
In May 2001, the Company loaned $110,000 to Anthony J.
Delvicario, president of the Company's unconsolidated
subsidiary, American Inter-Metallics, Inc., and a member of
Diasense's board of directors. The original demand note was
secured by 110,000 shares of American Inter-Metallics, Inc.
common stock and bore interest at prime rate plus two
percent. In November 2001, the note was converted into a new
note for $114,000 to reflect accrued interest, payable in
monthly installments of $5,000. The note is secured by an
unconditional guaranty by American Inter-Metallics and all of
American Inter-Metallics' assets, including all of its
equipment.
Employment Contracts
The Company has employment contracts with change in control
provisions with four officers. In the event of a change in
control in the Company and termination of employment,
continuation of annual salaries at 100% decreasing to 25% are
payable in addition to the issuing of shares of common stock
as defined in the contracts. The contracts also provide for
severance, disability benefits and issuances of BICO common
stock under certain circumstances.
Consulting
In 2000, Thomas F. Feola, was engaged as an outside
consultant to assist with the identification and evaluation
of environmental companies for potential acquisitions,
mergers or strategic alliances. Thomas F. Feola is the
brother of Anthony J. Feola, COO and a director. The Company
paid Thomas Feola $64,000 in 2000 and $56,000 in 2001 for
these services which were terminated in August 2001.
NOTE P- COMMITMENTS AND CONTINGENCIES
Litigation
On April 30, 1996, a class action lawsuit was filed against
the Company, Diasense, Inc., and individual officers and
directors. The suit, captioned Walsingham v. Biocontrol
Technology, et al., was certified as a class action in the
U.S. District Court for the Western District of Pennsylvania.
The suit alleged misleading disclosures in connection with
the Noninvasive Glucose Sensor and other related activities,
which the Company denies. Without agreeing to the alleged
charges or acknowledging any liability or wrongdoing, the
Company agreed to settle the lawsuit for a total amount of
$3,450,000. As of December 31, 2001, $3,250,000 has been
paid toward the settlement. During the third quarter of
2001, the parties agreed to extend the payments on the
remaining balance. The remaining balance of 425,000 is
included in accrued liabilities, including $225,000 for
extending the due dates, and was due in the fourth quarter of
2001. Due to cashflow problems, the final payment was not
made in 2001. Payment is necessary in order to satisfy the
terms of the settlement. Although it is not known whether
the class action plaintiffs have been formally notified of
the settlement, or if they have accepted its terms, the
Company believes that the existing settlement will end this
matter.
Pennsylvania Securities Commission
The Pennsylvania Securities Commission is conducting a
private investigation of the Company and its subsidiary,
Diasense, Inc., in connection with the sale of securities.
The Companies have cooperated with and provided information
to the Pennsylvania Securities Commission in connection with
the private investigation. As the Commission's investigation
is not yet complete, there can be no estimate or evaluation
of the likelihood of an unfavorable outcome in this matter or
the range of possible loss, if any.
Additional Legal Proceedings
In April 1998, the Company and its affiliates were served
with subpoenas requesting documents in connection with an
investigation by the U.S. Attorneys' office for the U.S.
District Court for the Western District of Pennsylvania. The
Company continues to submit various scientific, financial and
contractual documents in response to such requests.
NOTE Q- EMPLOYEE BENEFIT PLAN
The Company has a defined contribution plan with 401(k)
provisions, which covers all employees meeting certain age
and period of service requirements. Employer contributions
are discretionary as determined by the Board of Directors.
There have been no employer contributions to the plan from
inception through December 31, 2001.
NOTE R - STOCK ACQUISITIONS
ICTI, Inc.
Effective March 4, 1998, pursuant to a Stock Purchase
Agreement dated February 20, 1998, the Company acquired 58.4%
of International Chemical Technologies, Inc. (ICTI) a
development stage corporation. ICTI commenced operations in
May 1997 and planned to engage in the business of
manufacturing and marketing, and licensing rights with
respect to certain corrosion/wear-resistant metal alloy
coating compositions.
Consideration for the purchase of the 58.4% interest in ICTI
included a cash payment of $1,030,000; a promissory note for
$3,350,000 at 8%; 2,000,000 shares of BICO common stock (fair
market value of $250,000), a warrant to purchase 1,000,000
shares of BICO stock for $2 per share anytime through March
4, 2003; and the guarantee by BICO of a promissory note for
$1,300,000 payable by ICTI to the seller.
The Company recognized $5,310,501 of goodwill in connection
with the ICTI Stock Purchase Agreement. For purposes of
amortizing this goodwill, management had determined a useful
life of 5 years. Accumulated amortization on this goodwill
was $887,080 at December 31, 1998. Based upon a reevaluation
of this goodwill, the remaining balance of $4,423,421 was
included in an impairment charge recognized in 1999.
Management's reevaluation was reached due to failure of the
investment to perform as anticipated and the decision that
future cash flow was unlikely. For these same reasons an
impairment charge of $637,530 was recorded to write off
associated plant and equipment.
B-A-Champ.com
Effective August 1, 2000, the Company acquired an additional
44.5% of B-A-Champ.com, Inc., a development stage
corporation. This additional investment increased the
Company's ownership of B-A-Champ.com, Inc. to 51%. B-A-
Champ.com, Inc. commenced operations in 1999 and plans to
engage in various internet promotional activities.
Consideration for the purchase of the additional 44.5%
interest in B-A-Champ.com, Inc. included a cash payment of
$400,000 and the conversion of a $50,000 note receivable from
B-A-Champ.com, Inc. plus accrued interest of $5,256 into
common stock.
The Company recognized $259,964 of goodwill in connection
with the acquisition of B-A-Champ.com, Inc. For purposes of
amortizing this goodwill, management has determined a useful
life of 5 years. Accumulated amortization on this goodwill
was $73,657 at December 31, 2001.
In 2001, most of the minority owners of B-A-Champ.com, Inc.
gave their shares to BICO increasing BICO's ownership to
99.8%.
INTCO, Inc.
Pursuant to a Stock Purchase Agreement dated November 1,
2000, Petrol Rem, Inc. acquired 51% of INTCO, Inc. INTCO,
Inc. was incorporated on February 5, 1981 and engages in oil-
spill cleanup and the treatment of oil wells and also
charters out self-propelled barges for maintenance work.
Consideration for the purchase of 51% on INTCO, Inc. included
a cash payment of $250,000 and a promissory note for $1
million. This promissory note was fully paid as of December
31, 2001.
The Company recognized $310,567 of goodwill in connection
with the INTCO Stock Purchase Agreement. For purposes of
amortizing this goodwill, management has determined a useful
life of 5 years. Accumulated amortization on this goodwill
was $72,465 at December 31, 2001.
Tireless, LLC
In October 2000, Petrol Rem, Inc. and Universal Scrap Tire
Company, LLC (an unaffiliated company) formed a joint venture
called Tireless, LLC (Tireless) with Petrol Rem, Inc. and
Universal Scrap Tire Company, LLC owning 51% and 49%,
respectively. Tireless is engaged in the acquisition,
shredding and disposal of tires and tire parts.
Consideration for the 51% ownership in Tireless included an
agreement by Petrol Rem to provide working capital funding of
$455,000 to Tireless. As of December 31, 2001, Petrol Rem
had invested $455,000 in Tireless and made loans to Tireless
totaling $381,160 to fund its operating and capital needs.
Petrol Rem recognized $164,611 of goodwill in connection with
the investment in Tireless. For purposes of amortizing this
goodwill, management has determined a useful life of 5 years.
Accumulated amortization on this goodwill was $52,145 as of
December 31, 2001.
NOTE S - SUBSEQUENT EVENTS
Preferred Stock
During January and February 2002, we issued 570,000
additional shares of our Series J preferred stock.
In February 2002, we accepted a $25 million funding
commitment from J.P. Carey Asset Management. The initial
funding will be through their purchase of $7.5 million of our
Series K preferred stock after our registration statement
covering the 620 million shares needed to cover the Series K
conversions is declared effective by the Securities and
Exchange Commission.
Common Stock
During the first quarter 2002, we issued approximately 101.25
million shares of our common stock from the Form S-8.
Bridge Loan
In March 2002, we obtained a $4 million bridge loan
commitment to help us meet our cash flow needs until the
registration statement covering the common stock underlying
our preferred stock is declared effective and we begin
receiving funding from our $25 million commitment from J.P.
Carey Asset Management discussed above. The bridge loan is
repayable in one year. $1 million of the $4 million commitment
had been placed in escrow as of March 29, 2002. These funds
will be released from escrow upon the filing of the Company's
registration statement. This $1 million loan was collateralized
by all equipment and other property of the Company.
Planned Subsidiary Disposition
In the first quarter 2002 the Company's Board of Directors
directed Management to pursue the disposition of two
consolidated subsidiaries, Ceramic Coatings Technologies,
Inc., and B-A-Champ.com (dba True Points.com). In 2001,
these two subsidiaries had losses of $(962,000) and
$(1,226,313) respectively, which were included in the
consolidated results of operations of the Company.
Clinical Trials
The clinical trials, which were being performed on the
Company's noninvasive glucose sensor were discontinued during
the first quarter of 2002 so that efforts could be directed
toward the development of a new generation device. The
clinical trials for the new device are being planned but will
be deferred until Management determines that adequate funding
is available. Total costs incurred during 2001 for the
clinical trials were approximately $1,900,000.