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____________________________________________________________________
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K
/X/ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF
THE SECURITIES EXCHANGE ACT OF 1934
For the fiscal year ended December 31, 1995
COMMISSION FILE NUMBER 0-17714
BIOPOOL INTERNATIONAL, INC.
(Exact name of Registrant as specified in its charter)
DELAWARE 58-1729436
(State or other jurisdiction of (I.R.S. Employer
incorporation or organization) Identification No.)
6025 Nicolle Street
Ventura, California 93003
(Address of principal executive offices) (Zip Code)
Registrant's telephone number including area code (805) 654-0643
Securities registered pursuant to section 12(b) of the Act: None
Securities registered pursuant to section 12(g) of the Act:
Title of each class Name of each exchange
on which registered
Common Stock, par value $.01 per share NASDAQ
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 proceeding 12 months (or for such
shorter period that the Registrant was required to file such
reports), and (2) has been subject to such filing requirements for
the past 90 days.
YES [X] NO [ ]
Indicate by check mark if disclosure of delinquent filers pursuant to
Item 405 of Regulation S-K 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 Biopool International, Inc. Common
Stock, $.01 par value, held by non affiliates, computed by reference
to the average of the closing bid and asked prices as reported by
NASDAQ on March 14, 1996, was $10,781,683.
Number of shares of Common Stock of Biopool International, Inc., $.01
par value, issued and outstanding as of December 31, 1995:
7,935,751. Portions of Registrant's Proxy Statement relating to its
1996 Annual Meeting of Stockholders are incorporated by reference in
Part III of this Annual Report.
_______________________________________________________________________
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INDEX TO ANNUAL REPORT
ON FORM 10-K
PART I Page
____
Item 1. Business. 3
Item 2. Properties. 12
Item 3. Legal Proceedings. 13
Item 4. Submission of Matters to a Vote
of Security-Holders. 13
PART II
Item 5. Market for the Registrant's Common Equity
and Related Stockholder Matters. 14
Item 6. Selected Financial Data. 14
Item 7. Management's Discussion and Analysis of
Results of Operations. 16
Item 8. Financial Statements and Supplementary Data. 19
Item 9. Changes in and Disagreements with Accountants
on Accounting and Financial Disclosure. 19
PART III
Item 10. Directors and Executive Officers of the
Registrant. 20
Item 11. Executive Compensation. 20
Item 12. Security Ownership of Certain Beneficial
Owners and Management. 20
Item 13. Certain Relationships and Related Trans-
actions. 20
PART IV
Item 14. Exhibits, Financial Statement Schedules,
and Reports on Form 8-K. 21
Signatures
2
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PART I
ITEM 1. BUSINESS
Biopool International, Inc. (which, together with its subsi-
diaries, is herein referred to as the "Company" or "Biopool") is
engaged in the research, development, manufacture, and marketing of
in vitro diagnostic products, which are sold on a worldwide basis to
hospitals, clinical laboratories, and research institutions.
Biopool, headquartered in Ventura, California, was incorporated
in Delaware in 1987 and currently maintains three wholly-owned
operating subsidiaries, each of which carries on research, manu-
facturing, and sales and marketing activities:
- Biopool AB ("Biopool Sweden") in Umea, Sweden, was acquired by
Biopool in March 1988.
- Biopool Canada Inc. ("Biopool Canada," formerly Inter-Haematol
Inc.) in Burlington, Ontario, Canada, was acquired by Biopool in
January 1990.
- Medical Diagnostic Technologies, Inc. ("MeDiTech") in Ventura,
California, was acquired by Biopool in January 1992.
The Company markets its products through a network of independent
distributors in over 35 countries around the world. Biopool's
subsidiaries also market the combined product lines directly to
hospitals and clinical laboratories in their own domestic markets. A
substantial portion of the Company's revenue comes from private-label
and OEM sales of its products to other companies who are selling to
the same markets. Biopool also engages in customized development and
production of its product range to meet the specific requirements of
corporate clients.
PRODUCTS
The Company's products address three general areas of the market
for in vitro diagnostic reagents and controls, namely:
* Blood coagulation, fibrinolysis, and platelet and vascular
function. Such products are used to:
- diagnose patients who have suffered clot-related circulatory
diseases such as myocardial infarction, stroke, embolism, or
deep vein thrombosis
- diagnose patients who are suffering from certain bleeding
diseases
- monitor patients undergoing therapy for such diseases
- identify patients at high risk for such diseases
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* Clinical chemistry reagents and controls for use in:
- diagnosing patients for pathological organ dysfunction; i.e.,
heart, liver, pancreatic, etc., diseases
- blood profile testing
- providing daily quality control data substantiating the
accuracy of test results
- calibrating and controlling the functionality of laboratory
analyzers
* Toxicology controls, such as:
- drugs of abuse controls to effectively monitor the analyzer
and technician variables associated with identifying abused
substances, such as cocaine, marijuana, amphetamines, etc., in
patient samples
A summary of certain key products is as follows:
* Test Kits Used for the Measurement of Various Components of the
Fibrinolytic System
The fibrinolytic system consists of a number of enzymes and other
proteins that participate in limiting the size of blood clots and in
the dissolution of blood clots that form when the blood vessel wall
is damaged. The clot forms around clumped or aggregated blood
platelets forming a temporary "plug" to prevent blood loss. When the
fibrinolytic system is improperly balanced (hypoactive), the blood
clot can become oversized and disrupt blood flow, resulting in tissue
damage. The principal enzyme involved in fibrinolysis is plasmin.
Plasmin is formed from its inactive precursor, plasminogen, by the
action of naturally occurring enzymes, tissue plasminogen activator
(tPA), and urokinase plasminogen activator (uPA). A high plasma
level of the principal inhibitor of plasminogen activators, PAI-1
(plasminogen activator inhibitor, type 1), has been described in the
scientific literature as an important risk factor in developing
venous and arterial thrombosis. Hyperactive fibrinolysis, including
decreased levels of inhibitors, may result in bleeding problems.
Some representative fibrinolytic product lines manufactured by
Biopool include:
TintElize-R- and Imulyse-TM- -- Biopool's ELISA (enzyme-linked
immunosorbent assay) products used for measuring tPA, uPA, PAI-1,
PAI-2, and Lp(a) antigen. Lp(a), a lipoprotein which contains a
surface protein with structural similarity to plasminogen, has been
described as an important new indicator for the risk of developing
atherosclerotic disease.
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Spectrolyse-R- -- kits that measure enzymatic activity by
hydrolysis of a synthetic chromogenic substrate. Biopool makes these
kits for the determination of alpha-2-antiplasmin, tPA, and PAI-1
activity in plasma.
Minutex-R- -- kits that use the agglutination of latex beads to
detect certain analytes. Biopool markets such a kit for the deter-
mination of fibrin D-dimer, which is a rapid indicator of a clot
present in the circulation.
Stabilyte-TM- -- a unique patented blood collection device that
stabilizes tPA activity and other serine proteases in blood after
collection, greatly simplifying their measurement.
Fibrinolysis Reference Plasma -- a unique reference plasma used
as a clinical laboratory control for tPA and PAI-1 determination.
* Test Kits for the Measurement of Various Components of the Blood
Coagulation (Clotting) System
The coagulation system consists of a number of clotting factor
proteins that interact in a complex way to cause the polymerization
of fibrinogen to fibrin, resulting in clot formation. The clotting
factors, identified by Roman numerals (e.g., factor II, factor VIII,
etc.) also have inhibitors present in the circulation which limit
their activity. Congenital or acquired deficiencies of any of the
clotting factors may result in bleeding, while deficiencies in the
inhibitors are associated with thrombotic complications. Some
representative product lines manufactured by Biopool include:
Spectrolyse-R- -- as described above, are kits used to measure
the activity of a given analyte through hydrolysis of a synthetic
chromogenic substrate. Biopool makes kits for the determination of
factor VIII, plasminogen, protein C, antithrombin III, and heparin.
Bioclot-TM- -- kits that determine the plasma activity of a given
analyte by clotting time assay. Biopool makes Bioclot-TM- kits for
the determination of protein C and, in early 1996, received U.S. Food
and Drug Administration (FDA) approval to market an additional
Bioclot-TM- kit for the determination of protein S. Both of these
proteins are highly important, naturally occurring anticoagulants,
whose absence can result in severe thrombotic disorders.
Electroimmunodiffusion (EID) -- kits for the determination of
protein C, protein S, and von Willebrand factor.
Factor Deficient Plasmas -- human plasmas synthetically depleted
of individual clotting factors using specific monoclonal and
polyclonal antibodies. These plasmas are used as substrate plasmas in
the clinical laboratory in the determination of clotting factor
deficiency in patients.
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Hemostasis Reference Plasma -- a freeze-dried reference plasma
that has been assayed against international plasma standards
(obtained from the World Health Organization) for over 17 hemostasis
analytes and marketed as a universal control plasma.
* Products Used in the Routine Screening of the Coagulation System,
Monitoring Patients on Oral Anticoagulant or Heparin Therapy, and
Assessing Platelet Function
Thromboplastin -- used for monitoring patients on oral anti-
coagulant therapy, for routine coagulation system assessment, and in
specific clotting factor assays.
APTT Reagent -- used in the monitoring of patients on therapeutic
heparin, presurgical screening, routine coagulation system screening,
and in coagulation factor assays.
Fibrinogen Kit -- used in the routine determination of fibrinogen
when assessing bleeding disorders. There is an increasing interest
in the performance of fibrinogen assays as an abnormally high level
of plasma fibrinogen is considered a risk factor for thrombotic
disease.
Coagulation Control Plasmas -- freeze-dried, stabilized human
plasma used in the day-to-day control of routine coagulation tests.
FDP Collection Tube -- a specialized system of blood collection
designed for use in fibrin degradation product (FDP) assays and
compatible with a variety of commercially available FDP kits.
Platelet Aggregation Reagents -- used in the determination of
blood platelet abnormalities.
Ristocetin Cofactor Assay -- used in the diagnosis of von
Willebrand disease, one of the most common hereditary bleeding
disorders in the population.
* Newly Introduced Products for Clinical Chemistry and Toxicology
Drugs of Abuse Controls -- a system of multi-level, multi-
analyte, liquid-stable controls to be used as quality control checks
when testing for drugs of abuse (e.g., barbiturates, opiates,
amphetamines, etc.) in clinical laboratory and forensic lab settings.
Clinical Chemistry Reagents -- used for the determination of
blood constituents such as cholesterol, lipase, triglycerides,
alkaline phosphatase, blood urea nitrogen, and others.
MANUFACTURING AND QUALITY CONTROL
The Company currently manufactures its reagents and assembles its
test kits at its facilities in Ventura (California), Umea (Sweden),
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and Burlington (Canada). Many of the raw materials used in the
manufacture of its test kits, including polyclonal antibodies,
monoclonal antibodies, and purified proteins, are prepared by the
Company. In cases where raw materials are obtained from outside
sources, the Company avoids dependence on any one source. Human
plasma, an important starting material for many of the products, is
sourced from licensed blood banks and plasmapheresis centers. The
Company believes that the available sources of materials are adequate
for its present and anticipated needs.
All of the Company's products are manufactured in accordance with
Good Manufacturing Practices (GMP's) for Medical Devices as promul-
gated by the FDA. The Company is registered with the U.S. Drug
Enforcement Administration to handle Schedules I-V controlled
substances. Vial-filling, freeze-drying, microtiter plate-filling,
and processing equipment are adequate for the Company's present
needs. During 1995, the Company completed installation of additional
manufacturing equipment at its Ventura facility and expanded its
facility from 8,000 to 20,000 square feet with new state-of-the-art
clean rooms and laboratories. Management believes that two- to
three-fold volume increases can be accommodated with little addi-
tional investment in facilities.
SALES AND MARKETING
Biopool's strategies for market growth are three-fold:
* The Company currently has the broadest range of products of any
competitor in the hemostasis/fibrinolysis market, estimated to be
$600 million worldwide. At approximately 1% market share, Biopool
intends to gain further market share by enhanced sales through its
current distribution network and a continuing expansion of dealers
into new geographical areas.
* The worldwide in vitro diagnostics market is estimated to be $15-
18 billion, of which hemostasis is only a small part. The Company
has introduced products into ever-expanding segments of that diag-
nostics market, including toxicology controls (estimated at $50-100
million) and clinical chemistry reagents ($3-4 billion). The intro-
duction of such products further supports the Company's distribution
network to supply the end-user consumer with a broader range of
quality diagnostics from a single source.
* New product development is aimed at expanding the Company's
presence in the important area of cardiovascular disease diagnostics.
Many of the Company's products currently assess markers of cardio-
vascular risk; new products which serve to assess platelet function
are expanding Biopool's presence in this very important area.
No customer accounted for in excess of 10% of sales in 1995.
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RESEARCH AND DEVELOPMENT AND NEW PRODUCTS
Research and development activities are carried out at each of
the Company's three subsidiaries and continue to target new and
interesting in vitro diagnostic reagents and controls, which broaden
the Company's product offering to its marketing partners. Product
development efforts seek to identify specific market niches where the
Company may utilize its technology to develop unique, yet very "do-
able," products.
In 1995, Biopool obtained FDA approval for 7 new products:
- ALANINE AMINOTRANSFERASE CHEMISTRY REAGENT - a test system
routinely used in the clinical diagnosis of liver dysfunction.
- ALKALINE PHOSPHATASE CHEMISTRY REAGENT - a test system
routinely used in the clinical diagnosis of liver dysfunction.
- ASPARTATE AMINOTRANSFERASE CHEMISTRY REAGENT - a test system
routinely used in the clinical diagnosis of liver dysfunction.
- BLOOD UREA NITROGEN CHEMISTRY REAGENT - a test system
routinely used in the clinical diagnosis of kidney
dysfunction.
- CREATINE KINASE CHEMISTRY REAGENT - a test system routinely
used in the clinical diagnosis of heart, skeletal muscle, and
brain dysfunctions.
- LACTATE DEHYDROGENASE CHEMISTRY REAGENT - a test system
routinely used in the clinical diagnosis of tissue damage.
- TRIGLYCERIDES CHEMISTRY REAGENT - a test system routinely used
in the clinical diagnosis of atherosclerosis and coronary
heart disease.
In addition, two new products for platelet function testing have
been developed for use in the research setting, hopefully a prelude
to their future acceptance in routine clinical testing.
At least six new diagnostic kits are slated for release in 1996.
However, there is no assurance that any new test kits will receive
regulatory marketing approval or that they will gain market
acceptance.
In fiscal 1995, 1994 and 1993, the Company expended approximately
$199,000, $175,000 and $175,000, respectively, for research and
development. Management expects to moderately increase research and
development activities in 1996.
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MARKETS AND COMPETITION
The Company believes that the worldwide market for in vitro
diagnostics is approximately $15-18 billion and that the existing
market for blood coagulation, fibrinolysis, and thrombotic risk
factors is approximately $600 million. The Company expects its new
DOA control products to address a market that is currently estimated
at $50-100 million. The market for clinical chemistry reagents,
which the Company is just beginning to enter, is estimated at $3-4
billion worldwide.
Biopool markets its products and competes on a worldwide basis
against a number of companies, some of which are subsidiaries of
large pharmaceutical, chemical, and biotechnology firms whose
financial resources and research and development facilities are
substantially greater than those of the Company. These companies
include Dade International, Ortho Diagnostic Systems (a division of
Johnson and Johnson), Organon Teknika (a division of Akzo), Behring
Diagnostics (a division of Hoechst), Boehringer Mannheim, Sigma
Diagnostics, and Instrumentation Laboratory.
Also, a number of companies of a similar profile to Biopool are
engaged in the research and development of diagnostic test kits
relating to the Company's historical market niche of hemostasis/
fibrinolysis. Some of these include: Diagnostica Stago S.A.
(France), Chromogenix AB (Sweden), and Agen, Inc. (Australia).
Biopool is a recognized leader and innovator in its core busi-
ness. The Company believes its test kits and reagents compete on the
basis of price, relative ease of use, quality, accuracy, and preci-
sion. A number of the Company's competitors, including several of
those named above, are customers of Biopool through OEM and private-
label relationships.
CUSTOMERS
The Company's customers are dispersed over wide geographic areas,
and no customer exceeded 10% of sales in 1995. Sales in the United
States and Western Europe accounted for 50% and 32%, respectively, of
total sales during 1995.
PATENTS, TRADEMARKS, AND PROPRIETARY INFORMATION
The Company considers the protection of discoveries in connection
with its research and development on test kits important to its
business. The Company's research scientists seek patent protection
for technology when deemed appropriate and, to date, have filed and
assigned to the Company applications for United States and foreign
patents covering several general product areas.
The Company is also reliant on trade secrets, unpatented propri-
etary know-how, and continuing technological innovation to develop
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its competitive position. Many of the Company's key employees and
consultants have entered into confidentiality agreements and have
agreed to assign to the Company any inventions relating to the
Company's business made by them while in the Company's employ, or in
the course of services performed on the Company's behalf. However,
there can be no assurance that others may not acquire or independ-
ently develop similar or superior technology, or, if patents do not
issue with respect to products arising from research, that the
Company will be able to maintain information on such research as
proprietary technology or trade secrets. The Company performs an
ongoing assessment of the value of the costs capitalized in its
intangible assets.
The Company has established rights in the trademarks "Biopool,"
"MeDiTech," "Imulyse," "Spectrolyse," "Desafib," "Desafib X,"
"Chromolize," "TintElize," "Stabilyte," and "Minutex." The marks
TintElize-R- and Minutex-R- have been registered by the Company with
the United States Patent and Trademark Office.
GOVERNMENT REGULATIONS
The manufacture and sale of diagnostic products are subject to
regulation by the FDA in the United States and by comparable regu-
latory agencies in certain foreign countries in which the Company's
diagnostic products are sold. The FDA has established guidelines and
safety standards that are applicable to the preclinical evaluation
and clinical investigation of diagnostic products and regulations
that govern the manufacture and sale of such products. The FDA and
similar agencies in foreign countries have substantial regulations
that apply to the testing, marketing (including export), and manu-
facturing of products to be used for the diagnosis of disease. In
the United States, many diagnostic products may be accepted by the
FDA pursuant to a 510(k) notification. Such application must contain
information that establishes that the product in question is "sub-
stantially equivalent" to similar diagnostic products already in
general use. Over 50 of the Company's products have received
marketing approval via the 510(k) process.
The Company's manufacturing facilities in the U.S., Canada, and
Sweden, as well as any additional manufacturing operations that may
be established within or outside the United States, are subject to
compliance with GMP Regulations (see "Manufacturing"). The Company
is registered as a medical device manufacturer with the FDA and as a
manufacturer with the U.S. Drug Enforcement Administration. The
Company may also be subject to regulation under the Occupational
Safety and Health Act, the Environmental Protection Act, the Toxic
Substance Control Act, Export Control Act, and other present and
future laws of general application.
The Company's management believes that the manufacture and use of
the Company's products have no adverse environmental impact.
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RISK FACTORS
MANUFACTURING; RAW MATERIALS. The Company's manufacturing
process relies on the continued availability of high quality raw
materials, many of which it currently receives from specific vendors.
Although the Company believes that there are other sources of supply
available to it, a change in vendors, or in the quality of the raw
materials supplied to it, could have an adverse impact on its manu-
facturing process, and ultimately, on its finished products. On one
occasion recently, the Company experienced a disruption in the
quality of certain key raw materials, which created minor delays in
the ability of the Company to fill orders for its D-dimer test kits.
No assurance can be given that such variations will not in the future
cause more significant delays, or have a more detrimental impact on
any of the Company's products.
COMPETITION. The Company is engaged in a segment of the human
health care products industry that is highly competitive. Competi-
tors in the United States and elsewhere include major pharmaceutical,
chemical, and biotechnology companies, many of which have substan-
tially greater capital resources, marketing experience, research and
development staffs, and facilities than Biopool. Any of these
companies could succeed in developing products that are more effec-
tive than any that have been, or may be, developed by Biopool and may
also be more successful than Biopool in producing and marketing their
products. However, to date, many of these companies have relied on
Biopool as their source for certain key products.
INTERNATIONAL SALES. International sales accounted for approx-
imately 50% and 60% of Biopool's revenues in 1995 and 1994, respec-
tively. International sales can be subject to certain inherent
risks, including unexpected changes in regulatory requirements and
tariffs, difficulties in staffing and managing foreign operations,
longer payment cycles, problems in collecting accounts receivable,
and potentially adverse tax consequences. Biopool depends on third-
party distributors for a material portion of its international sales.
The loss of, or other significant reduction in sales to, certain of
these third-party distributors could have a material adverse effect
on the Company's business and results of operations. Approximately
25% of the Company's sales are made in Swedish Krona. Gains and
losses on the conversion of accounts receivable arising from inter-
national operations have in the past contributed, and may continue to
contribute, to fluctuations in the Company's results of operations.
In addition, increases in the exchange rate of the dollar to foreign
currencies could cause the Company's products to become relatively
more expensive to customers in an affected country, leading to a
reduction in sales or profitability in that country.
DEPENDENCE ON KEY MANAGEMENT. The Company's success will
continue to depend to a significant extent on the members of its
management team and, in particular, on its Chief Executive Officer,
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Michael D. Bick. The Company does not maintain any material insurance
on the lives of Dr. Bick or its other senior management. There can be
no assurance that the Company will be able to retain its executive
officers and key personnel or attract additional qualified members to
management in the future. The loss of services of Dr. Bick, or of
any key employee, could have a material adverse effect upon the
Company's business.
VOLATILITY OF STOCK PRICE. The Company's common stock is quoted
on the Nasdaq Small Cap Market, and there has been substantial
volatility in the market price of such common stock. The trading
price of the common stock has been, and is likely to continue to be,
subject to significant fluctuations in response to variations in
quarterly operating results, the gain or loss of significant con-
tracts, changes in management, announcements of technological inno-
vations or new products by the Company or its competitors, legis-
lative or regulatory changes, general trends in the industry, recom-
mendations by securities industry analysts, and other events or
factors. In addition, the stock market has experienced extreme price
and volume fluctuations which have affected the market price of the
common stock of many technology companies, in particular, and which
have, at times, been unrelated to operating performance of the
specific companies whose stock is affected.
EMPLOYEES
The Company has 47 full-time employees: 20 in the U.S., 17 in
Sweden, and 10 in Canada. Of these, many hold advanced degrees or
certifications in medical technology (including three Ph.D. degrees
in the biological sciences). The Company's ability to develop,
manufacture, market, and sell products and to establish and maintain
its competitive position in light of new technological developments
will depend, in large part, on its ability to attract and retain
qualified personnel. Certain of Biopool's employees are members of
national unions. The Company believes its relations with its
employees to be good.
FINANCIAL INFORMATION ABOUT FOREIGN AND DOMESTIC OPERATIONS AND
EXPORT SALES
The information is disclosed in Note 9 to the consolidated finan-
cial statements included herein under Item 14.
ITEM 2. PROPERTIES
Biopool International (combined with its MeDiTech subsidiary)
leases a 20,000 square foot facility in Ventura, California, pro-
viding administrative, laboratory, manufacturing, and warehouse
space, where Biopool's corporate offices are also located. Under the
terms of the five-year lease agreement expiring in 1999, the base
rent for this facility is approximately $108,000 per year with annual
increments tied to the Consumer Price Index.
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Biopool Sweden leases a 7,800 square foot facility in Umea,
Sweden, providing administrative, laboratory, warehouse, and manu-
facturing space for an annual rental of approximately $87,000
pursuant to the terms of a ten-year lease expiring in 2002. The
lease provides for termination after four years without penalty at
the tenant's option.
Biopool Canada leases a 6,700 square foot facility in Burlington,
Ontario, pursuant to the terms of a ten-year lease expiring in 2002,
which provides for a yearly base rental of approximately $48,000 with
annual increments limited to increases in the Consumer Price Index.
This facility houses administrative, laboratory, warehouse, and
manufacturing facilities.
ITEM 3. LEGAL PROCEEDINGS
In December 1995, the Company settled a lawsuit with another
company. Under the terms of the settlement, the Company will pay
royalties on certain products sold after December 20, 1995. In
addition, the Company agreed to pay a total of $100,000, the total of
which was paid by its insurance company.
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY-HOLDERS
There were no matters submitted during the fourth quarter of the
fiscal year covered by this Report to a vote of stockholders, through
the solicitation of proxies, or otherwise.
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PART II
ITEM 5. MARKET FOR THE REGISTRANT'S COMMON EQUITY AND RELATED
STOCKHOLDER MATTERS
<TABLE>
The Company's common stock is traded in the over-the-counter
market under the NASDAQ symbol BIPL. The following sets forth the
high and low bid prices for the common stock for the periods
indicated as reported by the National Association of Securities
Dealers Automated Quotation System. Such prices represent prices
between dealers without adjustment for retail mark-ups, mark-downs,
or commissions and may not necessarily represent actual transactions.
<CAPTION>
HIGH LOW
<S> <C> <C>
COMMON STOCK:
1995:Fourth quarter 2-25/32 1-7/32
Third quarter 3 15/16
Second quarter 1-11/16 21/32
First quarter 1-1/4 13/16
1994:Fourth quarter 1-7/16 15/16
Third quarter 1-3/8 1-1/8
Second quarter 1-5/8 1
First quarter 1-11/16 1
</TABLE>
(a) On March 14, 1996, the closing bid price of the Company's
common stock, as reported by NASDAQ, was 1-11/16.
(b) As of March 14, 1996, there were 257 holders of record. A
large number of shares are held in nominee name. Based upon
information provided by the Company's transfer agent, American
Stock Transfer and Trust Company, the Company believes it had
approximately 2,000 shareholders on the same date.
(c) The Company has not paid any dividends since its inception and
does not contemplate payment of dividends in the foreseeable
future.
ITEM 6. SELECTED FINANCIAL DATA
The following selected financial data has been derived from the
consolidated financial statements of Biopool International, Inc., for
the five years ended December 31, 1995. The selected financial data
should be read in conjunction with the financial statements and notes
thereto included elsewhere herein and with "Management's Discussion
and Analysis of Financial Condition and Results of Operations."
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<TABLE>
YEAR ENDED DECEMBER 31
STATEMENT OF OPERATIONS DATA
<CAPTION>
1995 1994 1993(2)
<S> <C> <C> <C>
Sales $6,662,316 $ 5,527,139 $4,307,175
Research & development $ 199,334 $ 174,502 $ 174,540
Selling, general & administrative $2,748,158 $ 2,204,810 $1,439,547
Total operating income $6,477,328 $ 4,787,124 $3,861,305
Net income (loss) for the year $ 140,817 $ 705,331 $ 360,729
Net income (loss) per share $ .02 $ .09 $ .05
Weighted avg. shares outstanding 7,907,494 7,880,033 7,352,554
BALANCE SHEET DATA
(End of period):
Working capital $3,776,755 $ 3,664,981 $3,259,902
Total assets $7,435,741 $ 6,458,662 $5,839,628
Long-term debt $ 705,428 $ 262,222 $ 487,555
Total stockholders' equity(1) $5,933,944 $ 5,574,317 $4,768,764
<CAPTION>
1992(3) 1991
<S> <C> <C>
Sales $4,865,334 $ 2,662,087
Research & development $ 588,408 $ 532,760
Selling, general & administrative $1,506,100 $ 1,106,903
Total operating expenses $4,090,854 $ 3,077,500
Net Income (loss) for the year $ 626,670 $ (351,652)
Net Income (loss) per share $ .09 $ (.07)
Weighted avg. shares outstanding 6,705,866 5,503,874
BALANCE SHEET DATA
(End of period):
Working capital $1,298,328 $ 680,946
Total assets $4,094,906 $ 2,526,501
Long-term debt $ 527,795 $ 643,137
Total stockholders' equity(1) $2,556,585 $ 1,036,921
___________________________________________________________________________
<FN>
(1) See Consolidated Statements of Stockholders' Equity in the
Consolidated Financial Statements of Biopool International, Inc. and
Subsidiaries for an analysis of common stock transactions of Biopool
International, Inc.
(2) Sale of 1,166,334 shares of common stock (net proceeds amounted to
$1,967,818) in June 1993.
(3) MeDiTech purchased January 1, 1992.
</FN>
</TABLE>
15
<PAGE>
ITEM 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION
AND RESULTS OF OPERATIONS
1995 VERSUS 1994
Sales
Sales for the year ended December 31, 1995, increased from the
prior year approximately $1,135,000, or 21%, to $6,662,000 from
$5,527,000. This was due primarily to the introduction of eighteen
new products since 1992, increased expenditures in sales and
marketing, and the Company's continued emphasis in marketing its
product base under private label arrangements with larger companies.
Foreign transaction gains and losses for the Company were minimal in
1995 and 1994. The impact of foreign currency translation differ-
ences was considered insignificant in 1995.
The Company's customers are dispersed over wide geographic areas,
and no customer exceeded 10% of sales in 1995. Sales in the United
States and Western Europe accounted for 50% and 32%, respectively, of
total sales during 1995.
The Company believes that its sales will continue to be influ-
enced by many additional factors, including the introduction of new
diagnostic test kits, success in marketing its test kits to the
clinical market, increased awareness and demand for testing by
physicians, expansion of the Company's products into new geographic
areas through distributors and OEM relationships, and foreign
currency fluctuations. Rapid changes in technologies, demands for
chemistries, and the availability of high-quality raw materials may
also have a material impact on the Company's short- and long-term
sales.
Costs and Expenses
From 1994 to 1995, cost of sales increased by 9% to approximately
53% as a percentage of sales. The increase was primarily due to a
higher volume of product sales with lower profit margins in its
foreign subsidiaries in 1995. Research and development expenses
showed a minor increase to $199,000 in 1995 versus $175,000 in 1994.
The Company continues to invest in research and development aimed at
improvements to the existing product line, new diagnostic reagents in
hemostasis, and specialized clinical chemistry products. Research
and development expenses are expected to increase slightly in 1996.
Selling, general, and administrative expenses increased from
$2,205,000 in 1994 to $2,748,000 in 1995, an increase of approx-
imately 25%. This increase is, in large part, due to significant
non-recurring professional fees (approximately $430,000) which were
incurred in the defense of the Company's litigation with Medical
Analysis Systems (MAS). The Company expects selling costs to
increase slightly in 1996 due to the employment of a sales manager in
16
<PAGE>
the eastern U.S. and the continuing development of its market
strategy, which focuses on increasing market share. General and
administrative expenses are expected to decrease significantly as a
result of the settlement of the MAS litigation, a consequence of
which will be that the Company will no longer bear the professional
fees associated with this lawsuit.
Non-Operating Income (Expenses)
Interest income increased from $66,000 in 1994 to $98,000 in
1995, or 48%. This increase was due to investment into higher
interest-bearing securities in 1995. The Company's cash and cash
equivalent balances remained relatively constant through the third
quarter in 1995. Cash expenditures for capital additions and
professional fees occurred primarily in the fourth quarter.
Interest expense increased from $46,000 in 1994 to $61,000 in
1995, or 33%, due to the Company's financing of leasehold improve-
ments and equipment added to the U.S. facility.
Income Taxes
The Company's provision for income taxes represents primarily
foreign government income taxes. The Company has net operating loss
carryforwards of approximately $3.0 million in the United States
available to offset future taxable income.
1994 VERSUS 1993
Sales
Sales for the year ended December 31, 1994, increased from the
prior year approximately $1,220,000, or 28%, to $5,527,139 from
$4,307,175. This was due primarily to the introduction of eleven new
products since 1992, increased expenditures in sales and marketing,
and the Company's continued emphasis in marketing its product base
under private label arrangements with larger companies. Foreign
transaction gains and losses for the Company were minimal in 1994 and
1993. The impact of foreign currency translation differences was
considered insignificant in 1994.
During 1994, the Company had one customer, Cosmo Bio (Japan),
which accounted for 11% of total sales. No other customer exceeded
10% of total sales in 1994. The Company's customers are dispersed
over wide geographic areas. Sales in the United States, Western
Europe, and the Asia/Pacific region accounted for 40%, 33%, and 14%,
respectively, of total sales.
Costs and Expenses
From 1993 to 1994, cost of sales decreased by 7% to approximately
44% as a percentage of sales. The decrease in the percentage of cost
17
<PAGE>
of sales was primarily due to a higher volume of product sales with
higher profit margins in its foreign subsidiaries in 1994. Research
and development expenses remained relatively constant at approx-
imately $175,000 in 1994 and 1993. The Company continues to invest
in research and development aimed at improvements to the existing
product line, new diagnostic reagents in hemostasis, and specialized
clinical chemistry products.
Selling, general, and administrative expenses increased from
$1,440,000 in 1993 to $2,205,000 in 1994, an increase of approx-
imately 53%. This increase is in large part due to the hiring
of additional personnel, including a Vice President of Sales and
Marketing, to support the Company's increased sales.
Non-Operating Income (Expenses)
Interest income increased from $28,000 in 1993 to $66,000 in
1994, or 136%. This increase was due to the investment of a portion
of the private placement proceeds (from June 1993) into short-term
interest-bearing securities.
Interest expense decreased from $95,000 in 1993 to $46,000 in
1994, or 52%, due to the Company's use of a portion of the proceeds
of the private placement to pay down certain higher interest debts.
Income Taxes
The Company's provision for income taxes, after utilization of
available net operating loss carryforwards, represents primarily
California income taxes and Canadian government income taxes.
LIQUIDITY AND CAPITAL RESOURCES
The Company's liquidity and capital resources remained relatively
strong in 1995. At December 31, 1995, the Company had a balance of
cash and cash equivalents amounting to $1,283,000 and unused lines of
credit of $698,000 available for its use. The Company may use a
portion of its cash to acquire businesses, products, or technologies
complementary to its business, although the Company has no such
commitments and no such acquisitions are currently being negotiated
or planned.
Cash flows used in operating activities amounted to $39,000 in
1995. In 1994, the Company had positive cash flows from operations
amounting to $811,000. The decrease relates to the significant
professional fees incurred in 1995 in defense of the MAS lawsuit and
the increased inventory levels necessary to meet current and
projected demand.
Cash flows from investing activities resulted in a decrease of
$1,171,000 for 1995 representing additions to property and equipment
in the U.S. facility to support increased production demands.
18
<PAGE>
Cash flows from financing activities resulted in an increase of
$492,000 for 1995 representing primarily long-term borrowings used to
finance a portion of its capital additions.
The Company believes that its current capital resources,
including existing cash and access to available lines of credit,
together with funds generated from operations, should be sufficient
to meet the Company's operating requirements in 1996.
ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
The financial statements and supplementary data have been
included under Item 14.
Item 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING
AND FINANCIAL DISCLOSURE
None
19
<PAGE>
PART III
ITEM 10. DIRECTORS AND EXECUTIVE OFFICERS OF THE REGISTRANT
Incorporated by reference to the Company's definitive Proxy
Statement to be filed with the Securities and Exchange Commission on
or before April 30, 1996.
ITEM 11. EXECUTIVE COMPENSATION
Incorporated by reference to the Company's definitive Proxy
Statement to be filed with the Securities and Exchange Commission on
or before April 30, 1996.
ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND
MANAGEMENT
Incorporated by reference to the Company's definitive Proxy
Statement to be filed with the Securities and Exchange Commission on
or before April 30, 1996.
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS
Incorporated by reference to the Company's definitive Proxy
Statement to be filed with the Securities and Exchange Commission on
or before April 30, 1996.
20
<PAGE>
PART IV
ITEM 14. EXHIBITS, FINANCIAL STATEMENT SCHEDULES, AND REPORTS ON FORM
8-K.
(a) Exhibits
Exhibit No.
3.1 Certificate of Incorporation (1)
3.2 Form of Amendment to Certificate of Incorporation (1)
3.3 By Laws (1)
4.1 Form of Five-Year Common Stock Purchase Warrant and list
of holders (3)
10.2 1987 Stock Option Plan (1)
10.6 1993 Stock Incentive Plan (4)
11.1 Computation of Earnings Per Share
16.1 Letter Relating to Change in Certifying Accountant (2)
21.1 Subsidiaries of the Registrant
_____________________________________________________________________
(1) Incorporated by reference to the Registrant's Registration
Statement on Form S-1 (File No. 33-20584).
(2) Incorporated by reference to the Registrant's current report on
Form 8-K filed with the Commission on October 20, 1989, as
amended by Amendment Nos. 1 and 2 thereto on October 26, 1989,
and November 8, 1989, respectively.
(3) Incorporated by reference to the Registrant's Annual Report on
Form 10-K for the fiscal year ended December 31, 1993.
(4) Incorporated by reference to the Registrant's Annual Report on
Form 10-K for the fiscal year ended December 31, 1994.
21
<PAGE>
PART IV
PAGE NO.
(b) Financial Statements
Report of Independent Auditors F-1
Consolidated balance sheets as
of December 31, 1995 and 1994 F-2
Consolidated statements of income
for the years ended December 31,
1995, 1994 and 1993 F-4
Consolidated statements of stock-
holders' equity for the years ended
December 31, 1995, 1994 and 1993 F-5
Consolidated statements of cash
flows for the years ended
December 31, 1995, 1994 and 1993 F-6
Notes to consolidated financial
statements F-7
(c) Financial Statement Schedule
Schedule II - Valuation and
qualifying accounts SC-1
Signatures SC-2
(d) Report on Form 8-K
Report on Form 8-K dated December 27, 1995.
22
<PAGE>
ANNUAL REPORT ON FORM 10-K
ITEM 14(a)(1) and (2)
LIST OF FINANCIAL STATEMENTS AND FINANCIAL STATEMENT
SCHEDULES
YEAR ENDED DECEMBER 31, 1995
BIOPOOL INTERNATIONAL, INC.
VENTURA, CALIFORNIA
<PAGE>
REPORT OF INDEPENDENT AUDITORS
Board of Directors and Stockholders
Biopool International, Inc.
We have audited the accompanying consolidated balance sheets of
Biopool International, Inc., as of December 31, 1995 and 1994, and the
related consolidated statements of income, stockholders' equity and
cash flows for each of the three years in the period ended December
31, 1995. Our audits also included the financial statement schedule
listed in the Index at Item 14(c). These financial statements and
schedule are the responsibility of the Company's management. Our
responsibility is to express an opinion on these financial statements
and schedule based on our audits.
We conducted our audits in accordance with 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 financial statements referred to above
present fairly, in all material respects, the consolidated financial
position of Biopool International, Inc., at December 31, 1995 and
1994, and the consolidated results of its operations and its cash
flows for each of the three years in the period ended December 31,
1995, in conformity with generally accepted accounting principles.
Also, in our opinion, the related financial statement schedule, when
considered in relation to the basic financial statements taken as a
whole, presents fairly in all material respects the information set
forth therein.
Ernst & Young LLP
Woodland Hills, California
March 6, 1996
F-1
<PAGE>
<TABLE>
BIOPOOL INTERNATIONAL, INC.
CONSOLIDATED BALANCE SHEETS
<CAPTION>
December 31,
1995 1994
_________________________________________________________________
<S> <C> <C>
ASSETS
CURRENT ASSETS
Cash and cash equivalents $ 1,282,527 $ 1,841,475
Accounts receivable, net
of allowance for doubtful
accounts of $2,856 and $10,445
in 1995 and 1994, respectively 1,153,608 875,978
Inventories 1,841,910 1,528,696
Prepaid expenses and other
current assets 414,880 109,939
Refundable income taxes 61,820 --
_________________________________________________________________
TOTAL CURRENT ASSETS 4,754,745 4,356,088
_________________________________________________________________
PROPERTY AND EQUIPMENT 3,485,030 2,480,480
Less accumulated depreciation
and amortization (1,713,952) (1,309,787)
_________________________________________________________________
PROPERTY AND EQUIPMENT, NET 1,771,078 1,170,693
_________________________________________________________________
OTHER ASSETS
Patent application costs, net 150,555 141,180
Excess of cost over net assets
of acquired companies, net 670,586 725,646
Other assets 88,777 65,055
_________________________________________________________________
TOTAL OTHER ASSETS 909,918 931,881
_________________________________________________________________
TOTAL ASSETS $ 7,435,741 $ 6,458,662
___________________________________________________________________
</TABLE>
See accompanying notes to consolidated financial statements.
F-2
<PAGE>
<TABLE>
BIOPOOL INTERNATIONAL, INC.
CONSOLIDATED BALANCE SHEETS
(continued)
<CAPTION>
December 31,
1995 1994
_________________________________________________________________
<S> <C> <C>
LIABILITIES AND STOCKHOLDERS' EQUITY
CURRENT LIABILITIES
Bank borrowings $ 22,331 --
Accounts payable 252,548 $ 218,056
Accrued wages and benefits 267,179 213,026
Accrued professional fees 136,444 78,070
Accrued interest 1,264 2,892
Accrued expenses 62,688 40,312
Income taxes payable 53,915 59,133
Current portion of long-term debt 181,621 68,984
Amount due to officer -- 10,634
_________________________________________________________________
TOTAL CURRENT LIABILITIES 977,990 691,107
__________________________________________________________________
LONG-TERM DEBT, NET 523,807 193,238
COMMITMENTS AND CONTINGENCIES
STOCKHOLDERS' EQUITY:
Common stock, $.01 par value,
50,000,000 shares authorized;
9,428,530 and 9,386,145
shares issued and outstanding
at December 31, 1995 and 1994,
respectively (less 1,492,779
shares held in treasury) 94,286 93,861
Additional paid-in capital 9,547,906 9,488,606
Accumulated deficit (3,813,162) (3,953,979)
Cumulative foreign currency
translation adjustment 104,914 (54,171)
_________________________________________________________________
TOTAL STOCKHOLDERS' EQUITY 5,933,944 5,574,317
_________________________________________________________________
TOTAL LIABILITIES AND STOCKHOLDERS'
EQUITY $ 7,435,741 $ 6,458,662
_________________________________________________________________
</TABLE>
See accompanying notes to consolidated financial statements.
F-3
<PAGE>
<TABLE>
BIOPOOL INTERNATIONAL, INC.
CONSOLIDATED STATEMENTS OF INCOME
<CAPTION>
Year Ended December 31,
1995 1994 1993
_________________________________________________________________________
<S> <C> <C> <C>
SALES $6,662,316 $5,527,139 $4,307,175
COSTS AND EXPENSES
Cost of sales 3,529,836 2,407,812 2,204,372
Selling, general
and administrative 2,748,158 2,204,810 1,439,547
Research and development 199,334 174,502 174,540
Patent and equipment
writedown -- -- 42,846
_________________________________________________________________________
TOTAL COSTS AND EXPENSES 6,477,328 4,787,124 3,861,305
_________________________________________________________________________
OPERATING INCOME 184,988 740,015 445,870
_________________________________________________________________________
OTHER INCOME (EXPENSE)
Interest income 97,923 65,928 28,110
Interest expense (60,751) (46,405) (94,749)
Gain (loss) on disposal of
assets (3,661) 26,323 --
Other 42,720 30,614 3,985
_________________________________________________________________________
Total other income (expense) 76,231 76,460 (62,654)
_________________________________________________________________________
Income before taxes 261,219 816,475 383,216
Income taxes 120,402 111,144 22,487
_________________________________________________________________________
NET INCOME $ 140,817 $ 705,331 $ 360,729
_________________________________________________________________________
NET INCOME PER SHARE $ 0.02 $ 0.09 $ 0.05
_________________________________________________________________________
</TABLE>
See accompanying notes to consolidated financial statements.
F-4
<PAGE>
<TABLE>
BIOPOOL INTERNATIONAL, INC.
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY
<CAPTION>
Cumulative
foreign
Additional currency
Common Stock paid-in Accumulated translation
Shares Amount capital deficit adjustment Total
________________________________________________________________________________________________________
<S> <C> <C> <C> <C> <C> <C>
BALANCE AT JANUARY 1, 1993 8,159,811 $ 81,598 $ 7,521,651 $(5,020,039) $ (26,625) $ 2,556,585
Issuance of common stock 1,186,334 11,863 1,959,755 1,971,618
Net income 360,729 360,729
Foreign currency translation (120,168) (120,168)
________________________________________________________________________________________________________
BALANCE AT DECEMBER 31, 1993 9,346,145 93,461 9,481,406 (4,659,310) (146,793) 4,768,764
Issuance of common stock 40,000 400 7,200 7,600
Net income 705,331 705,331
Foreign currency translation 92,622 92,622
________________________________________________________________________________________________________
BALANCE AT DECEMBER 31, 1994 9,386,145 93,861 9,488,606 (3,953,979) (54,171) 5,574,317
Issuance of common stock 42,385 425 59,300 59,725
Net income 140,817 140,817
Foreign currency translation 159,085 159,085
________________________________________________________________________________________________________
BALANCE AT DECEMBER 31, 1995 9,428,530 $ 94,286 $ 9,547,906 $(3,813,162) $ 104,914 $5,933,944
________________________________________________________________________________________________________
________________________________________________________________________________________________________
</TABLE>
See accompanying notes to consolidated financial statements.
F-5
<PAGE>
<TABLE>
BIOPOOL INTERNATIONAL, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
<CAPTION>
Year Ended December 31,
1995 1994 1993
<S> <C> <C> <C>
CASH FLOWS FROM OPERATING ACTIVITIES
Net Income $ 140,817 $ 705,331 $ 360,729
Adjustments to reconcile net income
to net cash provided by (used in)
operating activities:
Depreciation and amortization 390,977 368,246 258,144
Patent and equipment writedowns -- -- 42,846
(Gain) loss on disposal of assets 3,661 (26,323) --
Forgiveness of Biopool Sweden debt (8,369) (7,052) (15,344)
Compensation paid in stock 41,855 -- --
Changes in operating assets and
liabilities:
Accounts receivable (277,630) (124,301) 10,643
Inventories (313,214) (130,570) (42,818)
Prepaid expenses and other current
assets (107,071) (35,521) 40,345
Refundable income taxes (61,820) 22,859 (22,859)
Accounts payable 34,492 16,891 (163,638)
Accrued expenses 133,275 (31,778) 47,856
Income taxes payable (5,218) 53,410 (35,476)
Amount due to officer (10,634) 291 (49,726)
CASH PROVIDED BY (USED IN) OPERATING
ACTIVITIES (38,879) 811,483 430,702
CASH FLOWS FROM INVESTING ACTIVITIES
Additions to property and equipment (929,694) (537,201) (437,731)
Proceeds from disposal of assets 2,700 35,623 --
Patents and other assets (243,936) (57,512) (104,806)
CASH USED IN INVESTING ACTIVITIES (1,170,930) (559,090) (542,537)
CASH FLOWS FROM FINANCING ACTIVITIES
Short-term borrowings (repayments) 22,331 -- (226,231)
Repayment of long-term debt (97,985) (445,381) (98,339)
Issuance of long-term debt 549,560 227,100 73,443
Issuance of common stock 17,870 7,600 1,971,618
CASH PROVIDED BY (USED IN) FINANCING
ACTIVITIES 491,776 (210,681) 1,720,491
Effect of exchange rates 159,085 92,622 (29,731)
NET INCREASE (DECREASE) IN CASH (558,948) 134,334 1,578,925
CASH AND CASH EQUIVALENTS, BEGINNING
OF YEAR 1,841,475 1,707,141 128,216
CASH AND CASH EQUIVALENTS, END OF YEAR $1,282,527 $1,841,475 $1,707,141
SUPPLEMENTAL DISCLOSURE OF CASH FLOW
INFORMATION
Cash paid during the year for:
Interest $ 62,379 $ 94,100 $ 62,723
Income taxes $ 113,074 $ 42,794 $ 63,331
</TABLE>
F-6
<PAGE>
BIOPOOL INTERNATIONAL, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
1. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
DESCRIPTION OF BUSINESS
Biopool International, Inc. ("Biopool") was incorporated in 1987 in the
state of Delaware. Biopool and its wholly-owned subsidiaries, Biopool AB
("Biopool Sweden"), a Swedish corporation, Biopool Canada Inc. ("Biopool
Canada"), a Canadian corporation, and Medical Diagnostic Technologies, Inc.
("MeDiTech"), a California corporation, are currently engaged in research,
development, production, and sale of test kits used to assess and diagnose
disorders of the vascular system.
PRINCIPLES OF CONSOLIDATION
The consolidated financial statements of the Company include the
accounts of Biopool and its wholly-owned subsidiaries. All significant
intercompany balances and transactions are eliminated in consolidation.
PERVASIVENESS OF ESTIMATES
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.
CASH AND CASH EQUIVALENTS
Cash and cash equivalents represent highly liquid investments, generally
with a remaining maturity of three months or less.
INVENTORIES
Inventories are stated at the lower of cost (first-in, first-out) or
market.
PROPERTY AND EQUIPMENT
Property and equipment are stated at cost. Depreciation is generally
provided on a straight-line basis over their estimated useful lives, which
range from five to ten years.
F-7
<PAGE>
PATENT APPLICATION COSTS
Legal fees and other direct costs incurred in obtaining patents are
capitalized as incurred. Such costs are amortized over the shorter of the
life of the patent (seventeen years) or the related product on a straight-
line basis. Accumulated amortization at December 31, 1995 and 1994 totals
$67,442 and $54,473, respectively.
EXCESS OF COST OVER NET ASSETS OF ACQUIRED COMPANIES
The excess of cost over net assets of acquired companies is being
amortized using the straight-line method over a period ranging from ten to
twenty years. Accumulated amortization at December 31, 1995 and 1994 totals
$221,116 and $166,056, respectively.
RESEARCH AND DEVELOPMENT COSTS
Research and development costs are expensed when incurred and include
both internal research and development costs and payments to third parties by
the Company.
INCOME TAXES
The Company accounts for income taxes under Statement of Financial
Accounting Standards No. 109, "Accounting for Income Taxes." Income taxes
are provided based on earnings reported for financial statement purposes.
Deferred taxes are provided on the temporary differences between income for
financial statement and tax purposes.
FOREIGN CURRENCY TRANSLATION
Biopool Sweden and Biopool Canada assets and liabilities are translated
into U.S. dollars at the year-end exchange rate. The amounts in the
consolidated statements of income are translated at the average exchange rate
during the year. Cumulative translation adjustments are shown separately in
stockholders' equity and, accordingly, do not impact the results of
operations.
Exchange adjustments resulting from the foreign currency transactions
are generally recognized in net earnings. Net foreign transaction gains or
losses are not material in any of the years presented.
CONCENTRATIONS OF CREDIT RISK
Financial instruments, which potentially subject the Company to
concentrations of credit risk, consist principally of temporary cash
investments and trade receivables. The Company places its temporary cash
investments in Corporate Commercial Paper ($900,000 at December 31, 1995) and
with high-quality financial institutions. At December 31, 1995,
substantially all cash and cash equivalents were on deposit with two
financial institutions. Concentrations of credit risk with respect to trade
receivables are limited due to the large number of customers
F-8
<PAGE>
comprising the Company's customer base and their dispersion across many
different geographic areas. Accounts receivable from one customer amounted
to 15% of the net balance due at December 31, 1995. Generally, the Company
does not require collateral or other security to support customer
receivables.
NET INCOME PER SHARE
The net income per common share is based on the average number of common
shares outstanding during each year (1995 - 7,907,494; 1994 - 7,880,033; 1993
- - 7,352,554). The exercise of outstanding options would have an immaterial
effect on earnings per share.
FAIR VALUE OF FINANCIAL INSTRUMENTS
Based on borrowing rates currently available to the Company for bank
loans with similar terms and maturities, the fair value of the Company's
long-term debt approximates the carrying value. Furthermore, the carrying
value of all other financial instruments potentially subject to valuation
risk (principally consisting of cash and cash equivalents, accounts
receivable, bank borrowings, and accounts payable) also approximate fair
value.
ACCOUNTING FOR STOCK BASED COMPENSATION
In October 1995, the Financial Accounting Standards Board (FASB) issued
FASB Statement No. 123, "Accounting for Stock Based Compensation," which
requires companies to either expense the fair value of the employee stock
options or provide extensive new footnote disclosures of what net income
would have been had the expense been recognized. The Company intends to
elect the pro forma disclosure alternative in 1996. Adoption of FASB State-
ment No. 123 is not required until 1996 for calendar year-end companies.
Accordingly, the Company continues to report under the provisions of APB
Opinion No. 25, "Accounting for Stock Issued to Employees."
2. INVENTORIES
<TABLE>
Inventories consist of the following:
<CAPTION>
1995 1994
<S> <C> <C>
Raw materials $ 616,637 $ 448,318
Work-in-process 706,520 643,813
Finished goods 518,753 436,565
___________ ___________
$ 1,841,910 $ 1,528,696
___________ ___________
</TABLE>
F-9
<PAGE>
3. PROPERTY AND EQUIPMENT
<TABLE>
Property and equipment consist of the following:
<CAPTION>
1995 1994
<S> <C> <C>
Leasehold improvements $ 875,982 $ 344,225
Processing and laboratory equipment 2,200,525 1,900,486
Furniture and fixtures 408,523 235,769
___________ ___________
3,485,030 2,480,480
Less accumulated depreciation
and amortization (1,713,952) (1,309,787)
___________ ___________
$ 1,771,078 $ 1,170,693
___________ ___________
</TABLE>
4. NOTES PAYABLE TO BANKS
As of December 31, 1995, the Company's subsidiaries have unused lines of
credit of approximately $698,000 available for their use. The interest rate
on the lines of credit range from the bank's prime rate plus 1.25% to a fixed
rate of 12.75% and is payable monthly (quarterly in Sweden). The weighted
average interest rate on the balance outstanding at December 31, 1995, was
approximately 10.2%. The lines expire at varying dates from March 1996 to
December 1996. Substantially all assets of the Company's subsidiaries are
pledged as collateral for the lines of credit.
F-10
<PAGE>
5. LONG-TERM DEBT
<TABLE>
<CAPTION>
Long-term debt consists of the following: 1995 1994
___________________________________________________________________________
<S> <C> <C>
BIOPOOL SWEDEN
Notes payable, principally research grants,
for which the debt is expected to be forgiven
ratably through 1996 if sufficient related
research activities continue. $ 10,465 $ 18,834
___________________________________________________________________________
BIOPOOL CANADA
Term loans payable to a bank, due in monthly
installments of $1,665 and $2,572 plus interest
at the bank's prime rate (8.75% at December 31,
1995) plus 1.75%, due February 1999 and December
2000. The loans are collateralized by certain
machinery and equipment with a net book value
approximating the related outstanding debt. 208,313 76,728
___________________________________________________________________________
MEDITECH
Term loans payable to a bank, due in monthly
installments of $3,334 and $6,667 plus interest
at the bank's prime rate (8.25% at December 31,
1995) plus 1.5%, due February 1999 and June 2000,
collateralized by accounts receivable, invento-
ries, and property and equipment of MeDiTech. 486,650 166,660
___________________________________________________________________________
Total 705,428 262,222
Less portion due within one year 181,621 68,984
_________ _________
Long-term debt, net $ 523,807 $ 193,238
</TABLE>
<TABLE>
Scheduled aggregate principal reductions of long-term debt are due as
follows:
<S> <C>
1996 $ 181,621
1997 171,180
1998 168,734
1999 118,575
2000 65,318
_________
$ 705,428
</TABLE>
The term loans payable from Biopool Canada and MeDiTech to a bank
contain certain restrictions, including capital expenditures and payment of
dividends. The agreements also require minimum tangible net worth and ratios
of current assets to current liabilities, debt service coverage (as defined),
and total debt to tangible net worth.
F-11
<PAGE>
6. COMMITMENTS AND CONTINGENCIES
LEASES
<TABLE>
The Company leases certain equipment and facilities under operating
leases. Lease expense for 1995, 1994 and 1993 was approximately $268,000,
$196,000 and $195,000, respectively. At December 31, 1995, approximate
minimum annual lease commitments were as follows:
<S> <C>
1996 $ 258,000
1997 253,000
1998 252,000
1999 236,000
2000 137,000
Thereafter 223,000
___________
$ 1,359,000
___________
</TABLE>
ROYALTIES
The Company has joint research and development contracts under which
royalties will be paid as products are introduced into the market. The
royalties range from 3% to 15% of sales of the related products. Certain
contracts require additional payouts of 25% of sales, as defined, if licenses
are sold. The agreements expire over varying periods through 1997. Royalty
expense amounted to $52,820, $49,861 and $45,699 in 1995, 1994 and 1993,
respectively.
COMPENSATION AGREEMENT
The Company had an agreement with a former officer which provided
quarterly installments of 5% of Biopool Canada's gross profit, as defined.
The agreement, dated February 1990, expired December 31, 1994. The amounts
for 1994 and 1993 totalled $25,618 and $22,337, respectively.
LITIGATION
In December 1995, the Company settled a lawsuit with another company.
Under the terms of the settlement, the Company will pay royalties on certain
products sold after December 20, 1995. In addition, the Company agreed to
pay a total of $100,000, the total of which was paid by its insurance
company.
7. SALE OF COMMON STOCK
In June 1993, the Company issued 1,166,334 shares of its common stock
for a total of $1,967,818, net of costs associated with the issuance
amounting to $219,062. In connection with the sale of common stock, the
Company has issued warrants to purchase up to 174,950 shares of common stock
at a price of $1.875 and $3.50 per share. The warrants expire May 31, 1998.
F-12
8. STOCK PLANS
The Company has two stock option plans (the "Plans") for the benefit of
certain key employees, officers, directors, and consultants of the Company.
Under the Plans, a total of 1,820,148 shares of the Company's common stock
are reserved for issuance. Options granted under the Plans are generally
exercisable for a period of ten years from the date of grant at an exercise
price that is not less than fair market value of the common stock on the date
of grant. Options granted under the Plans generally vest over a one-year
period from the date of the grant.
<TABLE>
Stock option activity for 1993 through 1995 is as follows:
<CAPTION>
OUTSTANDING OPTIONS
Number Price
___________________________________________________________________________
<S> <C> <C>
BALANCE AT JANUARY 1, 1993 92,000
Cancelled (12,000)
Exercised (20,000) $ 0.19
Granted 507,414 $ 1.25 to $ 2.75
BALANCE AT DECEMBER 31, 1993 567,414
Cancelled (79,839)
Exercised (40,000) $ 0.19
Granted 362,758 $ 1.19 to $ 1.58
BALANCE AT DECEMBER 31, 1994 810,333
Cancelled (81,116)
Exercised (42,385) $ 1.19 to $ 1.44
Granted 345,833 $ 0.94 to $ 1.63
___________________________________________________________________________
BALANCE AT DECEMBER 31, 1995 1,032,665 $ 0.19 to $ 2.75
___________________________________________________________________________
</TABLE>
No amounts have been charged to expense relating to the Plans. At
December 31, 1995, options to purchase 351,922 shares were exercisable and
787,483 shares were available for future grants under the Plans.
F-13
<PAGE>
9. SIGNIFICANT SALES INFORMATION AND FOREIGN OPERATIONS
The Company currently operates in one industry, in vitro diagnostic
medical products, and sells its products worldwide through its three wholly-
owned subsidiaries. No customer accounted for more than 10% of total sales
in 1995. During 1994 and 1993, one customer accounted for 10.5% and 10.3%,
respectively, of total sales. Export sales by MeDiTech (the Company's
domestic operation) to customers in foreign countries (excluding intercompany
sales) accounted for approximately 15%, 22% and 24% of total sales in 1995,
1994 and 1993, respectively.
<TABLE>
The consolidated financial statements include the following informa-tion
for Biopool Sweden, Biopool Canada, and MeDiTech in thousands of dollars.
<CAPTION>
Elimina-
Biopool Biopool tions and
Sweden Canada MeDiTech Corporate Consolidated
___________________________________________________________________________
<S> <C> <C> <C> <C> <C>
1995
Sales $ 2,373 $ 1,805 $ 3,320 $ (836) $ 6,662
Less intercompany (381) (333) (122) 836 --
_______ _______ _______ _______ _______
$ 1,992 $ 1,472 $ 3,198 $ -0- $ 6,662
Net income $ 274 $ 90 $ 368 $ (591) $ 141
Identifiable assets $ 2,217 $ 1,088 $ 3,066 $ 1,065 $ 7,436
___________________________________________________________________________
1994
Sales $ 2,219 $ 1,399 $ 2,358 $ (449) $ 5,527
Less intercompany (209) (150) (90) 449 --
_______ _______ _______ _______ _______
$ 2,010 $ 1,249 $ 2,268 $ -0- $ 5,527
Net income $ 613 $ 165 $ 250 $ (323) $ 705
Identifiable assets $ 1,917 $ 939 $ 2,338 $ 1,265 $ 6,459
___________________________________________________________________________
1993
Sales $ 1,737 $ 1,044 $ 1,916 $ (390) $ 4,307
Less intercompany (119) (166) (105) 390 --
_______ _______ _______ ________ _______
$ 1,618 $ 878 $ 1,811 $ -0- $ 4,307
Net income $ 225 $ 103 $ 266 $ (233) $ 361
Identifiable assets $ 1,569 $ 694 $ 1,923 $ 1,654 $ 5,840
___________________________________________________________________________
</TABLE>
Product sales to affiliates are generally priced at cost plus 30%.
F-14
<PAGE>
<TABLE>
Information regarding the Company's sales by geographic locations is as
follows:
<CAPTION>
1995 1994
___________ ____________
<S> <C> <C>
United States $ 3,338,152 $ 2,190,401
Western Europe 2,143,604 1,851,026
Asia/Pacific Region 324,424 773,783
Canada 383,322 183,471
Other 472,814 528,458
___________ ____________
Total $ 6,662,316 $ 5,527,139
</TABLE>
10. INCOME TAXES
<TABLE>
The provision for income taxes is composed of the following:
<CAPTION>
1995 1994 1993
________ ________ ________
<S> <C> <C> <C>
Current:
Federal $ -- $ -- $ --
State (12,063) 37,103 9,772
Foreign 132,465 74,041 12,715
________ ________ ________
$ 120,402 $ 111,144 $ 22,487
</TABLE>
<TABLE>
The reconciliation of income tax computed at the U.S. Federal Statutory
rates to the income tax provision is as follows:
<CAPTION>
1995 1994
____________________ ____________________
<S> <C> <C> <C> <C>
Tax at U.S. statutory rate $ 88,814 34.0% $ 277,600 34.0%
State income tax (12,063) (4.6) 37,103 4.5
Creation (utilization) of
foreign and U.S. net
operating loss carry-
forwards 42,000 16.1 (288,000) (35.2)
Other 1,651 .6 84,441 10.3
____________________ ____________________
$ 120,402 46.1% $ 111,144 13.6%
F-15
<PAGE>
<CAPTION>
1993
____________________
<S> <C> <C>
Tax at U.S. statutory rate $ 130,300 34.0%
State income tax 9,772 2.5
Creation (utilization) of
foreign and U.S. net
operating loss carryforwards (130,800) (34.1)
Other 13,215 3.5
____________________
$ 22,487 5.9%
</TABLE>
<TABLE>
The components of the Company's deferred tax assets and liabilities at
December 31, 1995, are as follows:
<S> <C>
Depreciation and amortization $ (57,000)
Net operating loss carryforwards 1,226,000
Other 71,000
____________
1,240,000
Less valuation allowance (1,240,000)
____________
Deferred taxes, net $ -0-
</TABLE>
The valuation allowance increased approximately $42,000 in 1995,
representing primarily net operating losses incurred on the U.S. operations
in the current year.
Biopool Sweden and Biopool Canada file separate income tax returns in
Sweden and Canada, respectively. At December 31, 1995, the Company has
available net operating loss carryforwards of approximately $3,064,000 in the
United States. The United States carryforwards expire in varying amounts
through 2010. Under section 382 of the Internal Revenue Code, the
utilization of the federal net operating loss carryforwards may be limited
based on changes in the percentage of ownership in the Company.
The pretax income of the Company's foreign subsidiaries was approx-
imately $497,000, $852,000 and $341,000 at December 31, 1995, 1994 and 1993,
respectively.
Undistributed earnings of the Company's foreign subsidiaries amounted to
approximately $489,000 at December 31, 1995. Those earnings are considered
to be indefinitely reinvested and, accordingly, no provision for U.S. federal
and state income taxes has been provided thereon.
F-16
<PAGE>
<TABLE>
BIOPOOL INTERNATIONAL, INC.
SCHEDULE II - VALUATION AND QUALIFYING ACCOUNTS
<CAPTION>
Balance at Charged to Balance
beginning costs and at end
Account of period expenses Deductions of period
___________________________________________________________________________
<S> <C> <C> <C> <C>
YEAR ENDED
DECEMBER 31, 1995:
Allowance for
doubtful accounts $ 10,445 $ -- $ (7,589)(1) $ 2,856
YEAR ENDED
DECEMBER 31, 1994:
Allowance for
doubtful accounts $ 6,689 $ 3,814 $ (58)(1) $ 10,445
YEAR ENDED
DECEMBER 31, 1993:
Allowance for
doubtful accounts $ 1,759 $ 6,385 $ (1,455)(1) $ 6,689
<FN>
(1) Represents trade accounts deemed uncollectable and written off.
</FN>
</TABLE>
SC-1
<PAGE>
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this Report to be signed on its behalf by the
undersigned, thereunto duly authorized.
Biopool International, Inc.
Date: March 21, 1996 BY: /s/ Michael D. Bick
_________________________
Michael D. Bick, Ph.D.
Chief Executive Officer
Pursuant to the requirements of the Securities Exchange Act of 1934, this
Report has been signed below by the following persons on behalf of the
Registrant and in the capacities and on the dates indicated.
/s/ Michael D. Bick
____________________________ Chairman and March 21, 1996
Michael D. Bick, Ph.D. Chief Executive Officer
/s/ Andrew L. Cerskus
____________________________ Director March 21, 1996
Andrew L. Cerskus, Ph.D.
/s/ Jeffrey C. Hass
____________________________ Secretary/Treasurer March 21, 1996
Jeffrey C. Hass
/s/ Douglas L. Ayer
____________________________ Director March 21, 1996
Douglas L. Ayer
/s/ Lewis J. Kaufman
____________________________ Director March 21, 1996
Lewis J. Kaufman
SC-2
<PAGE>
EXHIBIT 11.1
<TABLE>
BIOPOOL INTERNATIONAL, INC.
COMPUTATION OF EARNINGS PER COMMON SHARE
<CAPTION>
1995 1994 1993
___________ ___________ ___________
<S> <C> <C> <C>
Net income for the year $ 140,817 $ 705,331 $ 360,729
Weighted avg. number
of shares outstanding 7,907,494 7,880,033 7,352,554
Net income per share $ 0.02 $ 0.09 $ 0.05
</TABLE>
<PAGE>
EXHIBIT 21.1
BIOPOOL INTERNATIONAL, INC.
SUBSIDIARIES OF THE REGISTRANT
Biopool AB ("Biopool Sweden")
P. O. Box 7133
S-907 04 Umea, Sweden
Biopool Canada Inc. ("Biopool Canada")
1016 Sutton Drive, Unit C8
Burlington, Ontario, Canada L7L 6B8
Medical Diagnostic Technologies, Inc. ("MeDiTech")
6025 Nicolle Street
Ventura, California 93003 U.S.A.
<TABLE> <S> <C>
<ARTICLE> 9
<S> <C>
<PERIOD-TYPE> YEAR
<FISCAL-YEAR-END> DEC-31-1995
<PERIOD-END> DEC-31-1995
<CASH> 319,698
<INT-BEARING-DEPOSITS> 962,829
<FED-FUNDS-SOLD> 0
<TRADING-ASSETS> 0
<INVESTMENTS-HELD-FOR-SALE> 0
<INVESTMENTS-CARRYING> 0
<INVESTMENTS-MARKET> 0
<LOANS> 204,536
<ALLOWANCE> 0
<TOTAL-ASSETS> 7,435,741
<DEPOSITS> 0
<SHORT-TERM> 203,952
<LIABILITIES-OTHER> 774,038
<LONG-TERM> 523,807
0
0
<COMMON> 94,286
<OTHER-SE> 5,839,658
<TOTAL-LIABILITIES-AND-EQUITY> 5,933,944
<INTEREST-LOAN> 0
<INTEREST-INVEST> 0
<INTEREST-OTHER> 0
<INTEREST-TOTAL> 0
<INTEREST-DEPOSIT> 97,923
<INTEREST-EXPENSE> 60,751
<INTEREST-INCOME-NET> 0
<LOAN-LOSSES> 0
<SECURITIES-GAINS> 0
<EXPENSE-OTHER> 0
<INCOME-PRETAX> 261,219
<INCOME-PRE-EXTRAORDINARY> 0
<EXTRAORDINARY> 0
<CHANGES> 0
<NET-INCOME> 140,817
<EPS-PRIMARY> .02
<EPS-DILUTED> .02
<YIELD-ACTUAL> 0
<LOANS-NON> 0
<LOANS-PAST> 0
<LOANS-TROUBLED> 0
<LOANS-PROBLEM> 0
<ALLOWANCE-OPEN> 0
<CHARGE-OFFS> 0
<RECOVERIES> 0
<ALLOWANCE-CLOSE> 0
<ALLOWANCE-DOMESTIC> 0
<ALLOWANCE-FOREIGN> 0
<ALLOWANCE-UNALLOCATED> 0
</TABLE>
