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SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 10-KSB
/X/ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF
THE SECURITIES EXCHANGE ACT OF 1934
For the fiscal year ended December 31, 1997
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:
Name of each exchange
Title of each class 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-KSB or any
amendment to this Form 10-KSB. / /
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
20, 1998, was $13,660,567.
Number of shares of Common Stock of Biopool International, Inc., $.01 par
value, issued and outstanding as of December 31, 1997: 8,648,828. Portions
of Registrant's Proxy Statement relating to its 1998 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-KSB
PART I Page
____
Item 1. Business. 3
Item 2. Properties. 17
Item 3. Legal Proceedings. 18
Item 4. Submission of Matters to a Vote
of Security-Holders. 18
PART II
Item 5. Market for the Registrant's Common Equity
and Related Stockholder Matters. 19
Item 6. Management's Discussion and Analysis of
Results of Operations. 19
Item 7. Financial Statements and Supplementary Data. 22
Item 8. Changes in and Disagreements with Accountants
on Accounting and Financial Disclosure. 22
PART III
Item 9. Directors and Executive Officers of the
Registrant. 23
Item 10. Executive Compensation. 23
Item 11. Security Ownership of Certain Beneficial
Owners and Management. 23
Item 12. Certain Relationships and Related Trans-
actions. 23
Item 13. Exhibits, Financial Statement Schedules,
and Reports on Form 8-K. 23
Signatures 25
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PART I
ITEM 1. BUSINESS
Biopool International, Inc. (together with its BCA Division and
subsidiaries, the "Company" or "Biopool") is engaged in the research,
development, manufacture, and marketing of in vitro diagnostic products.
Such products now number over 150 and are sold on a worldwide basis to
hospitals, clinical laboratories, commercial reference laboratories, blood
centers, and research institutions.
Biopool was incorporated in Delaware in 1987. In addition to the
corporate office in Ventura, California, the Company maintains two wholly-
owned operating subsidiaries and a division, each of which also carries on
product development, manufacturing, and sales and marketing activities:
- Biopool AB ("Biopool Sweden") in Umea, Sweden, acquired by Biopool in
March 1988.
- Biopool Canada Inc. ("Biopool Canada," formerly Inter-Haematol Inc.)
in Burlington, Ontario, Canada, acquired by Biopool in January 1990.
- BCA, Division of Biopool ("BCA"), in West Chester, Pennsylvania,
acquired by Biopool in January 1997.
In December of 1997, the Company announced that it will close down the
operations of Biopool Canada and consolidate the activities of this
facility with those of the Ventura facility. This consolidation is driven
by anticipated cost savings through the elimination of duplicative
administrative and facilities' overhead and manufacturing efficiencies.
The consolidation is expected to be completed by July 1998.
INDUSTRY
Biopool's products are sold to three specific market segments within
the worldwide in vitro diagnostics market. The total worldwide market is
estimated to be worth $18-20 billion annually, and the segments addressed
by the Company's products are estimated to be worth approximately $1
billion annually in the aggregate. Such diagnostic products are used, in
general, to diagnose disease, identify individuals at risk for developing
certain diseases, monitor patients undergoing therapy, and evaluate blood
components prior to transfusion. These products are typically referred to
as reagents or test kits and are used by highly trained laboratory
technologists utilizing a wide range of testing devices, which perform the
ultimate analysis. In a typical example, patient samples (blood, plasma,
urine, or other body fluids) are mixed with manufactured reagent(s), such
as those produced by Biopool, and a reaction is then measured by specific
instrumentation. The test result obtained thus provides certain diagnostic
information to the clinician.
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In vitro diagnostic products are utilized by health care professionals
worldwide. Diagnostic testing is most often performed in:
- hospital-based laboratories
- commercial reference laboratories
- blood centers
- physician office laboratories.
Biopool's products address three key segments of the total in vitro
diagnostics market:
1. Hemostasis/Fibrinolysis
The market for these reagents and test kits is approximately $600
million worldwide. 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; and
- identify patients at high risk for such diseases.
2. Blood Group Serology
Worldwide, the market for blood group serology products is estimated at
approximately $300 million. Generally, such products are used for:
- ABO blood grouping and compatibility tests prior to transfusion;
- typing for Rh and other blood group factors; and
- detection and identification of blood group antibodies.
3. Toxicology
Toxicology products include 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. The market for these controls
is estimated at $30-50 million worldwide.
Biopool's products are sold to over 4,000 customers worldwide. The
U.S. typically accounts for some 35% of the total worldwide diagnostics
market, Europe approximately 35%, Japan 10%, and 20% for the rest of the
world ("ROW").
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PRODUCTS
Test Kits Used for Measuring 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
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 the 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 products manufactured by Biopool include:
Minutex-R- D-dimer measures the D-dimer breakdown product of a fibrin
clot, indicating that clot formation has occurred and that the fibrinolytic
system has been activated. The Minutex-R- D-dimer test is useful in the
diagnosis of deep vein thrombosis, pulmonary embolism, and disseminated
intravascular coagulation (DIC).
Chromolize-TM- tPA measures the level of tissue plasminogen activator
(tPA), the body's most potent activator of the fibrinolytic system.
Decreased release of active tPA has been shown to be a risk indicator for
myocardial infarction.
Chromolize-TM- PAI-1 measures plasminogen activator inhibitor-1 (PAI-1)
levels in plasma. PAI-1 is a major modulator of tPA activity, and elevated
levels are also indicative of the risk of recurrent heart attacks,
recurrent deep vein thrombosis, and post-operative thrombosis.
Chromolize-TM- uPA measures urokinase-type plasminogen activator in
plasma and tissues. Its most important use may be in conjunction with
numerous recent clinical reports indicating high levels of uPA in breast
cancer patients may be prognostic for increased risk of relapse and death.
There are also reports that uPA is an independent variable for the
identification of high-risk gastric carcinoma patients.
Stabilyte-TM- is a unique patented blood collection device that
stabilizes tPA activity and other serine proteases in blood after
collection, greatly simplifying their measurement and leading to a more
accurate assessment of these key fibrinolytic enzymes.
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Test Kits for Measuring 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 (clot-forming) complications. Some representative product lines
manufactured by Biopool include:
Bioclot-TM- Protein C and Bioclot-TM- Protein S measure key enzymes and
regulatory proteins controlling the clotting process. Both tests are
approaching routine use in test panels screening for thrombotic risk. The
Bioclot-TM- tests are easy to perform and are compatible with all routine
hemostasis analyzers.
Bioclot-TM- LA is another of the easy to perform Bioclot-TM- assays, in
this case used to detect the presence of lupus-like anticoagulants (LA).
Elevated levels of LA present a considerable risk factor for thrombosis and
recurrent spontaneous abortion.
Spectrolyse-R- AT III measures antithrombin III (AT III) levels in
plasma, the most important inhibitor of clotting activity within the
hemostasis system. Decreased levels of this key protein are prognostic of
thrombotic risk.
Factor Deficient Plasmas are 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.
Hemostasis Reference Plasma is a freeze-dried reference plasma that has
been assayed against international plasma standards (obtained from the
World Health Organization) for 24 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 is used for monitoring patients on oral anticoagulant
therapy (i.e., coumadin), for routine coagulation system assessment, and in
specific clotting factor assays.
APTT Reagent is used in the monitoring of patients on therapeutic
heparin, pre-surgical screening, routine coagulation system screening, and
in coagulation factor assays.
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Fibrinogen Kit is 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 are freeze-dried, stabilized human plasmas
used in the day-to-day control of routine coagulation tests.
FDP Collection Tube is 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 are used in the determination of blood
platelet abnormalities.
Ristocetin Cofactor Assay is used in the diagnosis of von Willebrand
disease, one of the most common hereditary bleeding disorders in the human
population.
Blood Group Serology Products
The products manufactured by the Company's BCA Division are primarily
used to detect the absence or presence of antigens and antibodies in blood
components. Antigens are present on the surface of red cells, one of the
primary cellular blood components. Antibodies are present in the serum or
plasma and are produced as a result of contact with foreign substances
(antigens). The four major blood groups are A, B, AB, and O and are
measured by the presence or absence of antigens on red blood cells. Many
other blood group systems have been identified, and twenty antigens within
these systems are routinely included in blood bank testing. It is
imperative that the blood bank technologist correctly match the donor blood
to the patient's blood type, thus requiring the use of products such as
those manufactured by BCA.
The BCA product line includes 43 products licensed by the U.S. Food and
Drug Administration ("FDA") and 11 products approved by the 510(k)
submission process. These products are used to determine the presence or
absence of antigens and antibodies in blood. The BCA products are
categorized into several major areas. The following list encompasses the
products and applications for use.
Monoclonal ABO Antisera are used to detect and identify ABO antigens on
the surface of red blood cells. Test results determine the A, B, AB, or O
blood type of the specimen. These products are also able to identify
certain weak antigens previously detectable only by time-consuming,
laborious techniques.
Rh Typing Antisera is used to detect Rh antigens on the surface of red
blood cells. Primary use is to classify the specimen as Rh positive or Rh
negative.
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Anti-Human Globulin Reagents allow for the antigen and antibody to link
together so the reaction is detected. Primarily used in cross-matching and
in antibody screening and identification procedures.
Potentiators increase the sensitivity of antibody detection tests while
decreasing the time needed to perform such tests. Used in cross-matching
and in antibody screening and identification procedures. A variety of
potentiators are available to suit all blood banking needs.
Reagent Red Blood Cells are used to detect and identify antibodies in
patient or donor blood, confirm ABO blood grouping results, and verify the
addition and performance of the anti-human globulin reagent. Cells are
carefully selected to provide the maximum reactivity.
Rare Antisera are used to detect the presence or absence of other
clinically significant rare blood group antigens.
Quality Control Kits are used to check and confirm the consistent
performance of routine blood bank reagents.
Specialty Reagents adsorb unwanted antibodies from the test system so
that clinically significant antibodies can be detected. The reagents
provide the special tools needed to resolve complex serological cases in an
easy-to-use format.
Proficiency Testing Kits are used to check the proficiency of the
medical technologist to insure the accuracy of blood banking techniques.
Separate kits are available and are designed to provide the appropriate
level of difficulty.
Miscellaneous Products
Drugs-of-Abuse Controls are a system of multi-level, multi-analyte,
liquid-stable controls used as quality control checks when testing for
drugs of abuse (e.g., barbiturates, opiates, amphetamines, etc.) in
clinical laboratory and forensic lab settings. SURE-Urine-TM- is a unique
synthetic-based (non-human) drugs-of-abuse control developed by the
Company, which eliminates the biohazard concerns of commonly used human-
based materials.
Products Under Development and R&D
Biopool carries out product development activities at each of its four
worldwide facilities. Most product development is aimed at broadening the
product offering in the market niches already served by the Company,
introducing updated versions (quicker, more user-friendly, more accurate,
etc.) of current products, and conducting research aimed at evaluating
technology applicable to new methods of diagnostic testing.
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Biopool received FDA 510(k) approval to market one new product in 1997,
Spectrolyse-R- Heparin (anti-IIa). This test kit performs a quantitative
determination of heparin, one of the most commonly used anticoagulants, in
patient plasma. A Product Licence Application was submitted to the FDA for
Anti-D Monoclonal/Polyclonal Blend, a new blood grouping reagent, in May
1997; and a 510(k) filing was submitted in January 1998 for Fetal D-
Tection-TM- Kit, a product that detects fetal red cells in maternal
circulation.
For the fiscal years ended December 31, 1997 and 1996, the Company spent
$389,000 and $263,000, respectively, for research and development.
Management expects to increase such expenditures by at least 25% in 1998,
in part due to certain contract R&D activities under consideration at two
major blood centers.
Current product development activities include:
Hemostasis
- - Development of a new generation D-dimer kit (Auto-Dimer-TM-) that can
be used on automated clinical chemistry analyzers. D-dimer is
currently the Company's largest selling hemostasis product, and the
Company believes the market for D-dimer testing will continue to grow.
Its current format is a latex-agglutination slide test that is manually
performed and read by a technologist. Pilot lots of the new Auto-
Dimer-TM- kit have been completed, and clinical evaluations were begun
at three European sites in January 1998. FDA approval to market this
product in the U.S. is expected by mid to late 1998.
- - To further augment Biopool's position in D-dimer testing, the Company
has collaborated with a European instrument manufacturer to use the
Auto-Dimer-TM- reagent with a rapid, point-of-care device to
quantitatively measure D-dimer in patient blood.
- - In 1995, the Company acquired certain technology from the University of
Alberta to be used in developing a test kit for the diagnosis of
Heparin-Induced Thrombocytopenia ("HIT"). Pilot lots were produced in
mid-1997, and clinical evaluations are currently underway in
collaboration with an instrument supplier that has expressed interest
in selling the Company's HIT kit to users of their instrumentation.
Blood Group Serology
The development of hybridoma technology has led to a widespread
availability of monoclonal antibodies for use in blood group serology
reagents. The Company recognizes the potential for the application of
monoclonal antibodies to several of its blood bank products and is pursuing
a program to introduce monoclonal-based products wherever the technology
proves to be advantageous.
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The Company currently markets six FDA-approved monoclonal-based
reagents. Three of the antiglobulin reagents contain monoclonal anti-C3,
prepared from clones owned by the Company. Raw material for the remaining
products are currently purchased from a single supplier. Should the supply
of these materials from this source be interrupted, the Company anticipates
alternate sources could be located.
Biopool is pursuing the development of the following reagents using
purchased monoclonal antibodies: Anti-D (IgM), Anti-D (IgM/IgG), Anti-C,
Anti-c, Anti-E, and Anti-e. Product License Applications for these
reagents are expected to be completed and submitted to the FDA by second
quarter 1998. In May 1997, a Product License Application was submitted to
the FDA for Anti-D Monoclonal/Polyclonal Blend, a blood grouping reagent
for slide, rapid tube and micro-plate testing. A new product for detecting
fetal red cells in maternal circulation, Fetal D-Tection-TM- Kit, was
developed in 1997, and a 510(k) filing was submitted to the FDA in January
1998.
The Company maintains an active liaison with university and other
research-based technology transfer groups and is currently evaluating
various product concepts and core technologies that could be applicable to
its hemostasis and blood group serology product lines.
The Company is actively evaluating other sources of monoclonal
antibodies for its blood group serology reagents in order to reduce
reliance upon a single supplier and to also offer a unique set of
monoclonals to present a differentiated product line.
MANUFACTURING AND QUALITY CONTROL
The Company currently manufactures its reagents and assembles its test
kits at its facilities in Ventura, California; West Chester, Pennsylvania;
Umea, Sweden; 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 where possible. Human plasma, an
important starting material for many of the products, is sourced from
licensed blood banks and plasmapheresis centers. Red cell products are
prepared from whole blood collected and sold by licensed blood banks. 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 promulgated by the
FDA. All Company facilities are registered as Device Manufacturing
Establishments with the FDA. The BCA facility is further licensed by the
FDA for the manufacture of biological products. Three U.S. FDA product
licenses are in effect allowing for the manufacture and distribution of
blood group serum, reagent red blood cells, and anti-human globulin
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products. 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. Management believes
that two- to three-fold volume increases can be accommodated with little
additional investment in facilities. Furthermore, the BCA facility in West
Chester has been certified to meet the requirements of ISO 9001 standards
of quality. The Company's Ventura facility is currently undergoing
preparations to become ISO certified, which is expected to be achieved by
late 1998 to early 1999.
MARKETING AND DISTRIBUTION
The Company markets and sells its products domestically through
regional and national distributors and ten outside sales representatives,
including two regional sales managers. The Company's sales personnel are
highly experienced in the technical aspects of the product line and include
blood bank specialists and others with advanced degrees in medical
technology.
Biopool's products are sold outside of the U.S. through an extensive
network of independent distributors. With the acquisition of BCA from
Organon Teknika Corporation in January 1997, the Company entered into a
distribution agreement with Organon Teknika B.V. ("OTI") allowing for the
continuance of blood group serology product distribution through OTI
foreign affiliates on a non-exclusive worldwide (non-U.S.) basis. Since
that time, many OTI affiliates have continued to place routine orders for
the products and act as regional distributors. In certain territories, the
Company has elected to appoint other distributors for the sale of blood
group serology products (notably Canada and the U.K.).
The Company's sales and marketing activities are supported by two
directors of marketing, one for hemostasis products and one for blood group
serology products. Customer service and technical services are supported
by a staff of six employees. The technical service personnel provide
continuing education to customers through sponsored workshops and
consultation services and also prepare and provide numerous examples of
technical support documentation. Gulf Coast Regional Blood Center in
Houston, Texas, is retained by the Company as an outside consultation
laboratory to further service customer needs.
The Company's customer base is now over 4,000 end-users, with non-U.S.
distribution utilizing over 50 independent dealers in more than 50
countries. The Company augments its direct sales activities through active
participation in a number of key regional, national, and international
industry trade shows, including the American Association of Clinical
Chemistry, the American Association of Blood Banking, the American Society
of Hematology, Clinical Laboratories Management Association, and Medica
(Dusseldorf, Germany). The Company also maintains a visible domestic
market presence by exhibiting at over 20 regional blood bank meetings
annually.
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In addition to direct sales activities, the Company's products are
distributed in the U.S. through Columbia Diagnostics, InfoLab, LABSCO, and
Perigon, which collectively cover all 50 states with over 180 sales
representatives. The Company also has agreements with Allegiance
Healthcare and Fisher Healthcare to supply its blood group serology
products to those customers with which they maintain compliant contract
business.
Biopool also has significant sales derived from private label ("PL")
and Original Equipment Manufacturer ("OEM") business with other companies
in the hemostasis and drugs-of-abuse testing markets. Such PL/OEM accounts
include Biosite Diagnostics, Dade Behring (formerly Dade International),
Instrumentation Laboratory, Organon Teknika (a division of Akzo Nobel),
Ortho Diagnostic Systems (a division of Johnson & Johnson), Pacific
Hemostasis (a division of Fisher Scientific), and Sigma Diagnostics
(Sigma/Aldrich).
No customer accounted for over 10% of sales during 1997.
PL/OEM products accounted for 17% of sales in 1997.
Sales by geographic region for 1997 were: U.S. and Canada $10,877,000,
Europe $3,821,000, Asia-Pacific $796,000, and ROW $1,011,000. Management
expects a similar breakdown of sales by geographic area for 1998.
MARKETS AND COMPETITION
The Company believes that the worldwide market for in vitro diagnostics
is approximately $18-20 billion and that the existing market for blood
coagulation, fibrinolysis, and thrombotic risk factors is approximately
$600 million. The total worldwide blood group serology market is
approximately $300 million. The Company's current product range thus
addresses a worldwide market of approximately $1 billion.
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. In the hemostasis area, these companies include
BioMerieux, Boehringer Mannheim, Dade Behring, Instrumentation Laboratory,
Organon Teknika (a division of Akzo Nobel), Ortho Diagnostic Systems (a
division of Johnson and Johnson), and Sigma Diagnostics (Sigma/Aldrich).
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, a
subsidiary of Instrumentation Laboratory), and Agen, Inc. (Australia).
Biopool currently has approximately a 2% worldwide market share in total
hemostasis products and up to a 20-30% share in certain specialty
hemostasis/fibrinolysis products.
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In the blood group serology business, major competitors include Ortho,
Immucor, and Gamma Biologicals, with approximately 45%, 27%, and 15% U.S.
market share, respectively. The BCA products enjoy an approximate 5% U.S.
market share. In addition to these same competitors worldwide, other
competitors include Diamed (Switzerland), Biotest (Germany), and Diagast
(France). BCA products have a non-U.S. market share of approximately 1%.
Competition is based upon a number of factors, including product
quality, customer service, price, continuous availability of product,
breadth of product range, and the strength and effectiveness of the sales
and marketing organization. The Company believes its test kits and
reagents compete on the basis of price, relative ease of use, quality,
accuracy, and precision.
SUPPLIERS
The Company obtains raw materials from numerous outside vendors. Key
raw materials include whole blood, plasma, anti-sera, platelets, and
monoclonal antibodies. The Company generally has more than one source for
its raw materials, except for certain monoclonal antibodies utilized in its
blood group serology products. The Company continually evaluates
additional suppliers to reduce its dependence on any single vendor.
Certain of the Company's hemostasis products are derived from plasma
obtained from individuals with rare genetic deficiencies of certain
clotting factors (such as factor VIII, Hemophilia A). In order to reduce
reliance on this diminishing resource, the Company has in recent years
developed methodologies in-house to prepare "immuno-depleted" plasmas that
mimic these congenital disorders.
Within the blood group serology product line, certain products are
derived from the blood of individuals with rare combinations of antigens
and/or antibodies. Such donor individuals are rare, and the Company has
from time to time experienced delays or disruptions in supplies. However,
sales of products derived from these rare blood types are not material.
During 1997, the Company derived approximately $1.8 million
(approximately 11% of its total revenues) from the distribution and sale of
"Bayrho-R-," a therapeutic Rh immunoglobulin manufactured by Bayer. The
Company has experienced from time to time, and continues to experience,
back orders and disruptions in supply of Bayrho-R- from the manufacturer.
The Company has no alternate source of supply for a product equivalent to
Bayrho-R-. Prolonged disruption in the supply of this product will likely
lead to the loss of customers for, and future sales of, this product, and
such loss could have a material adverse impact on the Company's operating
results.
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
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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 proprietary
know-how, and continuing technological innovation to develop 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 independently 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 "Auto-Dimer,"
"Imulyse," "Spectrolyse," "Desafib," "Desafib X," "Chromolize,"
"TintElize," "Stabilyte," "Accucell-16," "Re CAP," "Quik Chek," "W.A.R.M.,"
"RESt," "HPC," "Acculiss," EM-V," "EM-X," "Fetal D-Tection," and "Self-
Check." The marks Biopool-R-, BCA-R-, TintElize-R-, Minutex-R-,
Tencell-R-, Spectrogen-Duo-R-, Spectrogen-Trio-R-, Confirmcells-R-, and
Coatagen-R- have been registered by the Company with the United States
Patent and Trademark Office and in many foreign territories.
GOVERNMENT REGULATIONS
The manufacture and sale of diagnostic products are subject to
regulation by the FDA in the United States and by comparable regulatory
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 manufacturing 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 "substantially equivalent" to similar diagnostic products
already in general use. Over 70 of the Company's products have received
marketing approval via the 510(k) process.
The manufacture and distribution of products intended for use in blood
banks is a highly regulated business. The Company is subject to ongoing
compliance with various federal, local and international laws, regulations
and rules regarding establishment and product licensing, as well as product
labeling and other manufacturing and testing activities. During the first
half of 1997, BCA manufactured and distributed blood bank reagents under
Establishment License #956-004 granted to Organon Teknika, Inc., from which
the business was purchased. The Company received its own Establishment
License in August 1997 (#1227). During November and December 1997, the
14
<PAGE>
Company submitted over 15 product applications to the l'Agence du
Medicament, the French regulatory agency, for approval to begin marketing
the full product range in France. Additional applications will be
submitted in early 1998, with approvals expected to be received during the
second quarter of 1998.
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.
RISK FACTORS
Loss of Revenue from Distribution of Products. The Company derives a
significant portion of its revenue from the distribution and sale of
products manufactured by third parties. During 1997, the Company derived
approximately $1.8 million of its total revenue (approximately 11%) from
the distribution and sale of "Bayrho-R-," a therapeutic Rh immunoglobulin
manufactured by Bayer. The Company has experienced from time to time, and
continues to experience, back orders and disruptions in supply of Bayrho-R-
from the manufacturer. The Company has no alternate source of supply for a
product equivalent to Bayrho-R-. Prolonged disruption in the supply of
Bayrho-R- will likely lead to the loss of customers for, and future sales
of, this product, and such loss could have a material adverse effect on the
Company's operating results.
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 manufacturing process and, ultimately, on its
finished products. The Company has from time to time experienced a
disruption in the quality or availability of certain key raw materials,
which has created minor delays in the ability of the Company to fill orders
for certain 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. Competitors in the
United States and elsewhere include major pharmaceutical, chemical, and
biotechnology companies, many of which have substantially greater capital
resources, marketing experience, research and development staffs, and
facilities than Biopool. Any of these companies could succeed in
15
<PAGE>
developing products that are more effective 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 approximately
37% and 48% of Biopool's revenues in 1997 and 1996, respectively.
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 15% of the Company's sales are made in Swedish
Krona. Gains and losses on the conversion of accounts receivable arising
from international operations have in the past contributed, and may
continue to contribute, to fluctuations in the Company's results of
operations. During 1997, the strengthened value of the U.S. dollar to the
Swedish Krona resulted in a negative impact on stated consolidated revenues
of $321,000 and a negative impact of $39,000 on net profit. In addition,
increases in the exchange rate of the dollar to foreign currencies have
caused the Company's products to become relatively more expensive to
customers in certain countries, leading to a reduction in sales or
profitability in some isolated cases. The closure of the Company's
Canadian operations is not expected to have a material impact on sales.
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, 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 contracts, changes in management, announcements
of technological innovations or new products by the Company or its
competitors, legislative or regulatory changes, general trends in the
industry, recommendations 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.
16
<PAGE>
EMPLOYEES
At the end of 1997, the Company had 114 full-time, permanent employees:
86 in the U.S., 16 in Sweden, and 12 in Canada. Many employees hold
advanced degrees or certifications in medical technology. Five individuals
hold 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 Swedish 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 6 to the consolidated financial
statements included herein under Item 13.
ITEM 2. PROPERTIES
Biopool International leases a 20,000 square-foot facility in Ventura,
California, providing administrative, laboratory, manufacturing, and
warehouse space, where Biopool's corporate offices are also located. Key
manufacturing facilities include clean rooms, high-speed vial filling and
capping capabilities, and a freeze-drying capacity of up to 40,000 vials
per lot. 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. Operations from
Biopool Canada will be transferred to this location during the first half
of 1998. Management believes the existing Ventura facility will
accommodate these additional operations with few additions to leasehold
improvements.
The BCA facility is located in West Chester, Pennsylvania, and consists
of 36,000 square feet on a seven and one-half acre lot in a suburban office
park. Special features within the facility include three class 1000 clean
rooms, each containing a class 100 horizontal laminar flow hood.
Associated with the clean rooms are a changing room, entry corridor, exit
room, and pass-through dry heat and steam sterilizers. Two additional
clean rooms are designated as class 10,000. Each contains one or more
class 100 horizontal laminar flow hoods. Two manufacturing rooms contain
high-efficiency exhaust systems and class 1 respirator connections. There
is batch size capacity for bulk manufacture and sterile filtration for up
to 600 liters. Laboratory capabilities include serological assay,
defibrination, delipidation, adsorption, centrifugation, and determinations
for pH, protein, and chloride. Additional testing capabilities include
sterility testing and verification of cell concentration, fill volume, and
applied torque.
Biopool Sweden leases a 10,725 square-foot facility in Umea, Sweden,
providing administrative, laboratory, warehouse, and manufacturing space.
The laboratories are particularly suited for the preparation of high-
17
<PAGE>
quality biochemicals for use in the Company's test kits. Annual rent is
approximately $110,000 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.
The Company is currently seeking a sublessee to occupy the facility and
take over the lease payments when the Company completes its consolidation
of Biopool Canada, currently expected to be completed in July 1998.
ITEM 3. LEGAL PROCEEDINGS
From time to time the Company has been involved in legal proceedings
and claims in the ordinary course of its business. The Company is not
currently a party to, nor is it aware of, any legal proceeding or claim
which management believes will have, individually or in the aggregate, a
material adverse effect on the Company, or its financial condition or
results of operations.
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.
18
<PAGE>
PART II
ITEM 5. MARKET FOR THE REGISTRANT'S COMMON EQUITY AND RELATED STOCKHOLDER
MATTERS
<TABLE>
The Company's common stock trades on The Nasdaq Stock Market-SM under
the symbol BIPL. The following sets forth the high and low trade prices for
the common stock for the periods indicated as reported by Nasdaq. The
Company has not paid any dividends since its inception and does not
contemplate payment of dividends in the foreseeable future.
<CAPTION>
1997 1996
HIGH LOW HIGH LOW
<S> <C> <C> <C> <C>
Fourth quarter $3-13/16 $2- 3/8 $3- 9/16 $2- 1/16
Third quarter 2- 3/4 1-15/16 2- 7/16 1-11/16
Second quarter 2- 9/16 2 2- 9/16 1- 5/8
First quarter 3- 9/32 2- 1/8 2-11/16 1- 1/16
</TABLE>
(a) On March 20, 1998, the closing trade price of the Company's
common stock, as reported by Nasdaq, was $1.875.
(b) As of March 20, 1998, there were 229 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 3,000
shareholders on the same date.
ITEM 6. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND
RESULTS OF OPERATIONS
Acquisition of Blood Group Serology
On January 1, 1997, the Company purchased certain assets of the Blood
Group Serology Division of Organon Teknika Corporation (now "BCA") for
$4,500,000 in cash. An additional $229,000 of costs were capitalized in
1997. This acquisition had and will continue to have a significant impact
on the Company's operating results and financial condition. This
acquisition has approximately doubled the total sales; selling, general and
administrative expenses; and the number of employees of the Company during
1997.
Consolidation of Canadian Operations
On December 23, 1997, the Company announced the restructuring of its
operations by closing its facilities in Canada and consolidating the
operations of its subsidiary, Biopool Canada, with the operations conducted
at the Company's facilities in Ventura, California. The Company expects to
incur restructuring charges of approximately $450,000, of which $342,000
was charged to the fourth quarter of 1997. It is anticipated that the
transfer of technology and manufacturing will be completed by June 30,
19
<PAGE>
1998. Management anticipates significant cost savings due to the
elimination of duplicative overhead costs and economies of scale in
manufacturing beginning in the second half of 1998. The closure of the
Canadian manufacturing operations is not expected to have any long-term
negative impact on sales. The Company recently announced the signing of an
agreement with ESBE Scientific to market and distribute the Company's blood
group serology and hemostasis products throughout Canada.
1997 versus 1996
Sales
Sales for the year ended December 31, 1997, increased from the prior
year approximately $8,485,000, or 106%, to $16,505,000. While the majority
of the increase was due to the acquisition of BCA, sales from the core
hemostasis business grew approximately 2%, significantly less than in
recent years. Due to the strengthening of the U.S. dollar against the
Swedish Krona during 1997, sales made by Biopool Sweden were reduced by
$321,000. Historically, strong growth has come from the private label/OEM
market, which was flat during 1997. In response to the foregoing, sales
and marketing efforts have been expanded and diversified through domestic
and international distribution organizations and augmented by direct sales
to end-users, which are expected to have some impact on future sales
growth, but management does not expect, in the near term, a material
increase in sales as a result of these efforts.
Sales by quarter for the first three quarters of 1997 reflected
consistent, stable growth and were on target with budget. Sales for the
fourth quarter, however, dropped below the prior three quarters. This
decline in sales was across the board by geographic region, product group,
and distribution channel. Management has not identified any single reason
for this decline that would indicate any specific downward trend in the
Company's market other than the general pressures of price competition and
the strong U.S. dollar, which may be impacting foreign sales. This slower
pace of sales has now followed into the first quarter of 1998 exacerbated
by the unavailability of a finished product (Bayrho-R-) from a single
supplier. This product became backlogged in February without notice and
may not be available again until July of this year. For the year ended
December 31, 1997, sales of this product had been approximately $140,000
per month. The Company has no alternative source of supply for a product
equivalent to Bayrho-R-. Prolonged disruption in the supply of this
product will likely lead to the loss of customers for, and future sales of,
this product, and such loss could have a material adverse impact on the
Company's operating results.
The Company's customers are dispersed over wide geographic areas, and
no customer exceeded 10% of sales in 1997. Sales in the United States and
Western Europe accounted for 63% and 23%, respectively, of total sales
during 1997.
The Company believes that its future sales will continue to be
influenced by many additional factors, including the introduction of new
diagnostic test kits, success in marketing its test kits to the clinical
20
<PAGE>
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 direct sales through Company-employed sales
representatives. Rapid changes in technologies, demand level for certain
diagnostic tests, price competition, continued efforts worldwide to reduce
health care costs (including diagnostic testing), 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 1996 to 1997, cost of sales increased $5,931,000, or 145%, to
$10,023,000. The 1997 amount represents 61% as a percentage of sales,
compared with 51% for 1996. The gross increase in cost of sales is due
primarily to the acquisition of BCA, while the increases as a percentage of
sales are primarily due to under-utilized manufacturing capacity that
currently exists at the Company's BCA facility in West Chester,
Pennsylvania. Management is attempting to capitalize on this production
capacity by growing market share of existing products and adding new,
profitable product lines.
Selling, general and administrative expenses increased by $2,116,000
to $4,625,000 in 1997 from $2,509,000 in 1996. The majority of these
increases were due to the BCA acquisition. In addition to ongoing BCA
selling, general and administrative costs, significant transitional costs
were incurred in connection with the selection and installation of new
hardware and software and the subsequent training of employees; sales and
marketing efforts to establish new working relationships with domestic
distributors, enhance the Company's presence at domestic and international
trade shows, and expand its direct sales efforts; and the hiring and
training of a new customer service department. The Company also added
management positions during the latter part of 1996 in anticipation of
ongoing internal growth and acquisition activities.
Research and development expenses showed an increase to $432,000 in
1997 versus $263,000 in 1996. The Company continues to invest in research
and development aimed at improvements to the existing product line, new
diagnostic reagents in hemostasis and blood group serology, and evaluation
of newer technologies which may be applicable to current and future
diagnostic test kits. Research and development activities are expected to
increase approximately 25% in 1998.
Interest expense for 1997 increased $236,000 from $68,000 to $304,000
as a result of bank financing for the BCA acquisition.
Income Taxes
The Company's income tax benefit primarily represents state franchise
and foreign government income tax expense, which were offset by reductions
in the Company's deferred tax asset valuation allowance due to the
utilization of NOL carryforwards and a $200,000 reduction recognized in
1997 to reflect the estimated future benefit of the net deferred tax assets
21
<PAGE>
remaining at year end. All NOL benefits have now been utilized, which will
have the effect of increasing the Company's effective tax rate beginning
the first quarter of 1998.
Foreign Currency Translations
Foreign transaction gains and losses for the Company were minimal in
1996; however, during 1997, the devaluation of the Swedish Krona reduced
reported sales by $321,000 and net income by $39,000. The continuing
strength of the U.S. dollar had a dampening effect on certain foreign
sales, the dollar amount of which is difficult to measure for 1997 and
future sales. The impact of foreign currency translation differences
reduced stockholders' equity by $268,000 in 1997.
Impact of Year 2000
The Company's existing hardware and software are compliant with Year
2000 requirements; however, the Company has not yet performed an assessment
of computer systems belonging to customers, vendors, and other outside
parties with whom the Company does business. Such an assessment on
significant relationships will be performed during 1998. It is not
anticipated that such an assessment will reveal significant potential
problems nor incur significant costs.
Liquidity and Capital Resources
The Company's liquidity and capital resources remained strong
throughout 1997. Working capital as of December 31, 1997, was $5.5
million, with a current ratio of 3.1 to 1. Approximately $500,000 of the
Company's cash was used to establish working capital for the BCA
operations, which was purchased without accounts receivables and payables.
The total debt to equity ratio at December 31, 1997, was 31%, and
$1,206,000 in principal was paid during the year. The Company's management
does not expect any negative impact to the Company's financial condition
associated with the consolidation of its Canadian operations other than
one-time cash payments of approximately $300,000, plus the write-off of
tangible and intangible assets of approximately $150,000. The Company's
management believes that the current availability of cash, lines of credit,
working capital, and cash flow from operations are adequate to meet the
Company's needs for at least the next twelve months. The Company continues
to seek potential acquisitions and potential sources of capital to finance
such acquisitions, although it has no commitments for either at this time.
ITEM 7. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
The financial statements and supplementary data have been included
under Item 13.
ITEM 8. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND
FINANCIAL DISCLOSURE
None.
22
<PAGE>
PART III
ITEM 9. DIRECTORS AND EXECUTIVE OFFICERS
Incorporated by reference to the Company's definitive Proxy Statement
to be filed with the Securities and Exchange Commission on or before April
30, 1998.
ITEM 10. 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, 1998.
ITEM 11. 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, 1998.
ITEM 12. 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, 1998.
ITEM 13. EXHIBITS, FINANCIAL STATEMENT SCHEDULES AND REPORTS ON FORM 8-K
(a) (1) and (2) The following consolidated financial statements of
Biopool International, Inc., and subsidiaries are hereby included by
reference to Item 7:
PAGE NO.
Report of Independent Auditors 27
Consolidated balance sheets as of December 31,
1997 and 1996 28
Consolidated statements of income for the years
ended December 31, 1997 and 1996 30
Consolidated statements of stockholders' equity
for the years ended December 31, 1997 and 1996 31
Consolidated statements of cash flows for the years
ended December 31, 1997 and 1996 32
Notes to consolidated financial statements 33
23
<PAGE>
(3) Listing of Exhibits
EXHIBIT NO.
3.1 Certificate of Incorporation (1)
3.2 By Laws (1)
4.1 Form of Five-Year Common Stock Purchase
Warrant and list of holders (2)
10.2 1987 Stock Option Plan (1)
10.2 1993 Stock Incentive Plan (3)
21 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 Annual Report
on Form 10-K for the fiscal year ended December 31, 1993.
(3) Incorporated by reference to the Registrant's Annual Report
on Form 10-K for the fiscal year ended December 31, 1994.
(b) Reports on Form 8-K filed during the fourth quarter of 1997:
None.
24
<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 27, 1998 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 27, 1998
Michael D. Bick, Ph.D. Chief Executive Officer
/s/ Robert K. Foote
_____________________ Chief Financial Officer March 27, 1998
Robert K. Foote
/s/ Andrew L. Cerskus
_____________________ Director March 27, 1998
Andrew L. Cerskus, Ph.D.
/s/ Douglas L. Ayer
_____________________ Director March 27, 1998
Douglas L. Ayer
/s/ N. Price Paschall
_____________________ Director March 27, 1998
N. Price Paschall
25
<PAGE>
ANNUAL REPORT ON FORM 10-KSB
ITEM 13(a)(1) and (2)
LIST OF FINANCIAL STATEMENTS AND FINANCIAL STATEMENT
SCHEDULES
YEAR ENDED DECEMBER 31, 1997
BIOPOOL INTERNATIONAL, INC.
VENTURA, CALIFORNIA
26
<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, 1997 and 1996, and the related
consolidated statements of income, stockholders' equity and cash flows for
the years then ended. These financial statements are the responsibility of
the Company's management. Our responsibility is to express an opinion on these
financial statements based on our 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, 1997 and 1996, and the
consolidated results of its operations and its cash flows for the years then
ended, in conformity with generally accepted accounting principles.
Ernst & Young LLP
Woodland Hills, California
March 19, 1998
27
<PAGE>
<TABLE>
BIOPOOL INTERNATIONAL, INC.
CONSOLIDATED BALANCE SHEETS
<CAPTION>
December 31,
1997 1996
_______________________________________________________________________
(in thousands)
<S> <C> <C>
ASSETS
Current assets
Cash and cash equivalents $ 1,376 $ 2,019
Accounts receivable, net of allowance for
doubtful accounts of $81,000 and $11,000
in 1997 and 1996, respectively 2,677 1,560
Inventories 3,784 2,027
Prepaid expenses and other current
assets 286 289
_______________________________________________________________________
Total current assets 8,123 5,895
Property and equipment
Land 650 --
Building 1,750 --
Leasehold improvements 844 878
Processing and lab equipment 2,495 2,351
Furniture and fixtures 844 432
_______________________________________________________________________
Total property and equipment 6,583 3,661
Less accumulated depreciation (2,398) (2,018)
_______________________________________________________________________
Property and equipment, net 4,185 1,643
Other assets
Deposit on acquisition -- 4,500
Deferred tax benefits 686 400
Intangible assets 684 778
_______________________________________________________________________
Total other assets 1,370 5,678
_______________________________________________________________________
TOTAL ASSETS $13,678 $13,216
_______________________________________________________________________
_______________________________________________________________________
</TABLE>
See accompanying notes to consolidated financial statements.
28
<PAGE>
<TABLE>
BIOPOOL INTERNATIONAL, INC.
CONSOLIDATED BALANCE SHEETS
(continued)
<CAPTION>
December 31,
1997 1996
_______________________________________________________________________
(in thousands except share data)
<S> <C> <C>
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities
Accounts payable $ 513 $ 214
Accrued expenses 1,140 589
Income taxes payable 35 185
Bank borrowings -- 120
Current portion of long-term debt 964 852
_______________________________________________________________________
Total current liabilities 2,652 1,960
Long-term debt, net 1,873 2,811
Deferred tax liability 108 93
Commitments and contingencies -- --
Stockholders' equity:
Common stock, $.01 par value, 50,000,000
shares authorized; 8,648,828 and
8,570,380 shares issued and outstanding
at December 31, 1997 and 1996,
respectively 86 86
Additional paid-in capital 10,855 10,737
Accumulated deficit (1,675) (2,518)
Cumulative foreign currency translation
adjustment (221) 47
_______________________________________________________________________
Total stockholders' equity 9,045 8,352
_______________________________________________________________________
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $13,678 $13,216
_______________________________________________________________________
_______________________________________________________________________
</TABLE>
See accompanying notes to consolidated financial statements.
29
<PAGE>
<TABLE>
BIOPOOL INTERNATIONAL, INC.
CONSOLIDATED STATEMENTS OF INCOME
<CAPTION>
Year Ended December 31,
1997 1996
_______________________________________________________________________
(in thousands except share data)
<S> <C> <C>
Sales $16,505 $ 8,020
Cost of sales 10,023 4,091
_______________________________________________________________________
Gross profit 6,482 3,929
Operating expenses:
Selling, general and administrative 4,625 2,509
Research and development 432 263
Restructuring costs 342 --
_______________________________________________________________________
5,399 2,772
Interest expense 304 68
Other (income) expense, net (52) (91)
_______________________________________________________________________
Income before income taxes 831 1,180
Income tax benefit 12 115
_______________________________________________________________________
Net income $ 843 $ 1,295
_______________________________________________________________________
_______________________________________________________________________
Earnings per share
Basic $ 0.10 $ 0.16
Diluted $ 0.09 $ 0.16
</TABLE>
See accompanying notes to consolidated financial statements.
30
<PAGE>
<TABLE>
BIOPOOL INTERNATIONAL, INC.
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY
(in thousands except share data)
<CAPTION>
Additional
Common Stock paid-in
Shares Amount capital
______________________________________________________________________
<S> <C> <C> <C>
BALANCE AT JANUARY 1, 1996 7,935,751 $ 79 $ 9,563
Issuance of common stock 634,629 7 1,174
Net income
Foreign currency translation
______________________________________________________________________
BALANCE AT DECEMBER 31, 1996 8,570,380 86 10,737
Issuance of common stock 78,448 -- 118
Net income
Foreign currency translation
______________________________________________________________________
BALANCE AT DECEMBER 31, 1997 8,648,828 $ 86 $10,855
______________________________________________________________________
<CAPTION>
Cumulative
foreign
currency
Accumulated translation
Deficit adjustment Total
______________________________________________________________________
<S> <C> <C> <C>
BALANCE AT JANUARY 1, 1996 $(3,813) $ 105 $ 5,934
Issuance of common stock 1,181
Net income 1,295 1,295
Foreign currency translation (58) (58)
______________________________________________________________________
BALANCE AT DECEMBER 31, 1996 (2,518) 47 8,352
Issuance of common stock 118
Net income 843 843
Foreign currency translation (268) (268)
______________________________________________________________________
BALANCE AT DECEMBER 31, 1997 $(1,675) $(221) $ 9,045
______________________________________________________________________
</TABLE>
See accompanying notes to consolidated financial statements.
31
<PAGE>
<TABLE>
BIOPOOL INTERNATIONAL, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
<CAPTION>
Year Ended December 31,
1997 1996
__________________________________________________________________________
(in thousands)
<S> <C> <C>
Operating activities
Net Income $ 843 $ 1,295
Adjustments to reconcile net income to net
cash provided by operating activities:
Depreciation 627 338
Amortization 104 98
Loss on disposal 39 --
Other non-current balance sheet changes (281) (137)
Changes in operating assets and liabilities:
Accounts receivable (1,117) (406)
Inventories 286 (185)
Prepaid expenses and other current assets 3 8
Accounts payable and accrued expenses 700 214
__________________________________________________________________________
Net cash provided by operating activities 1,204 1,225
Investing activities
Deposit on acquisition 4,500 (4,500)
Acquisition of BCA Division (4,701) --
Additions to property and equipment (569) (186)
__________________________________________________________________________
Net cash used in investing activities (770) (4,686)
Financing activities
Bank borrowings 260 98
Repayment of long-term debt (1,206) (539)
Issuance of long-term debt -- 3,506
Issuance of common stock 90 1,181
__________________________________________________________________________
Net cash provided by (used in) financing activities (856) 4,246
Effect of exchange rates (221) (48)
__________________________________________________________________________
Net increase (decrease) in cash (643) 737
Cash and cash equivalents, beginning of year 2,019 1,282
__________________________________________________________________________
Cash and cash equivalents, end of year $ 1,376 $ 2,019
__________________________________________________________________________
Supplemental disclosure of cash flow information
Cash paid during the year for:
Interest $ 282 $ 71
Income taxes $ 356 $ 56
</TABLE>
32
<PAGE>
BIOPOOL INTERNATIONAL, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
1. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Organization
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, and Biopool Canada Inc.
("Biopool Canada"), a Canadian corporation, and its newly acquired
division, BCA (see Footnote 8), are currently engaged in the 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 and division. All
significant intercompany balances and transactions are eliminated in
consolidation.
Revenues
Revenues are recorded on the day products are shipped from the Company's
facilities.
Use 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.
Reclassification
Certain data in the prior year consolidated financial statements have
been reclassified to conform to the 1997 presentation.
Cash and cash equivalents
Cash and cash equivalents represent highly liquid investments and which
mature within three months of date of purchase.
33
<PAGE>
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. The
Company's building is depreciated over 30 years. Leasehold improvements
are generally depreciated over their estimated useful lives or over the
period of the lease, whichever is shorter. All other assets are
depreciated over five to ten years.
Intangibles
Management periodically reviews intangible assets to determine
recoverability of these assets. 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,
1997 and 1996 totaled $61,000 and $48,000, respectively. 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, 1997 and 1996 totaled $366,000 and
$276,000, 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" (see Footnote
7).
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 and are generally insignificant.
34
<PAGE>
Concentration 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 Certificates of Deposit and with high-quality financial
institutions. At December 31, 1997, substantially all cash and cash
equivalents were on deposit with three financial institutions.
Concentrations of credit risk with respect to trade receivables are limited
due to the large number of customers comprising the Company's customer base
and their dispersion across many different geographic areas. Accounts
receivable from one customer amounted to 13% of the net balance due at
December 31, 1996. No single customer had accounts receivable greater than
10% of the net balance due at December 31, 1997. Generally, the Company
does not require collateral or other security to support customer
receivables.
Earnings per share
During the year ended December 31, 1997, the Company adopted SFAS No.
128, "Earnings Per Share," which required a change in the method used to
compute earnings per share. Under this new standard, primary and fully
diluted earnings per share were replaced with "Basic" and "Diluted"
earnings per share. Basic earnings per share amounts exclude the dilutive
effect of potential common shares, and there was no impact to the primary
earnings per share amounts previously presented. For Biopool, diluted
earnings per share amounts under the new standard were $0.01 per share
higher than the fully diluted earnings per share previously presented. As
required by SFAS No. 128, all prior period amounts have been restated to
conform to the new presentation.
Basic earnings per share is based upon the weighted-average number of
common shares outstanding. Diluted earnings per share is based upon the
weighted-average number of common shares and dilutive potential common
shares outstanding. Potential common shares are outstanding options under
the Company's stock option plans and outstanding warrants, which are
included under the treasury stock method.
35
<PAGE>
<TABLE>
The following table sets forth the computation for basic and diluted
earnings per share (in thousands except share data):
<CAPTION>
Years ended December 31,
1997 1996
<S> <C> <C>
Numerator for basic and diluted earnings
per share - net income $ 843 $1,295
______ ______
Denominator:
Denominator for basic earnings per share -
weighted-average shares 8,617 7,982
Effect of dilutive securities - employee
stock options and warrants 495 360
______ ______
Denominator for diluted earnings per share -
adjusted weighted-average shares 9,112 8,342
______ ______
Basic earnings per share $ 0.10 $ 0.16
Diluted earnings per share $ 0.09 $ 0.16
</TABLE>
Options to purchase 115,000 and 369,000 shares with exercise prices
greater than the average market prices of common stock were outstanding
during the years ended December 31, 1997 and 1996, respectively. These
options were excluded from the respective computations of diluted earnings
per share because their effect would be anti-dilutive.
Accounting for stock based compensation
Stock option grants are set at the closing price of the Company's
common stock on the day prior to the date of grant. Therefore, under the
principles of APB Opinion No. 25, the Company does not recognize
compensation expense associated with the grant of stock options. SFAS No.
123, "Accounting for Stock-Based Compensation," requires the use of option
valuation models to provide supplemental information regarding options
granted after 1994. Pro forma information regarding net income and
earnings per share shown below was determined as if the Company had
accounted for its employee stock options under the fair value method of
that statement.
The fair value of the options was estimated at the date of grant using
a Black-Scholes option pricing model with the following weighted average
assumptions: risk-free interest rates of 6.1% to 6.6%; dividend yields of
0% for 1997 and 1996; volatility factors of the expected market price of
the Company's common stock of 55% for 1997 and 51% for 1996; and expected
life of the options of one to five years as grouped by specific employee
classifications. These assumptions resulted in weighted average fair
values of $0.87 and $0.75 per share for stock options granted in 1997 and
1996, respectively.
36
<PAGE>
The Black-Scholes option valuation model was developed for use in
estimating the fair value of traded options. The Company's employee stock
options have characteristics significantly different from those of traded
options such as vesting restrictions and extremely limited transferability.
<TABLE>
For purposes of pro forma disclosures, the estimated fair value of the
options is amortized over the option vesting periods. The pro forma effect
on net income for 1997 and 1996 is not representative of the pro forma
effect on net income in future years because it does not take into
consideration pro forma compensation expense related to grants made prior
to 1995. Pro forma information in future years will reflect the
amortization of a larger number of stock options granted in several
succeeding years. The Company's pro forma information is as follows (in
thousands except share data):
<CAPTION>
Years ended December 31,
1997 1996
_______ _______
<S> <C> <C>
Pro forma net income $ 655 $ 1,119
Pro forma earnings per share
Basic 0.08 0.14
Diluted 0.07 0.14
</TABLE>
<TABLE>
Information regarding stock options outstanding as of December 31,
1997, is as follows:
<CAPTION>
Options Outstanding
_________________________________________________
Weighted
Weighted Average
Average Remaining
Price Range Shares Exercise Price Contractual Life
_____________________________________________________________________
<S> <C> <C> <C>
$0.9375 - $3.13 1,410,821 $1.78 8.7 years
<CAPTION>
Options Exercisable
___________________________
Weighted
Average
Price Range Shares Exercise Price
_______________________________________________
<S> <C> <C>
$0.9375 - $3.13 819,083 $1.52
</TABLE>
37
<PAGE>
2. INVENTORIES (in thousands)
<TABLE>
Inventories consist of the following:
<CAPTION>
1997 1996
______ ______
<S> <C> <C>
Raw materials $ 821 $ 448
Work-in-process 1,661 700
Finished goods 1,302 879
______ ______
$3,784 $2,027
</TABLE>
3. LONG-TERM DEBT (in thousands)
<TABLE>
<CAPTION>
Long-term debt consists of the following: 1997 1996
_______ _______
<S> <C> <C>
BIOPOOL CANADA
Term loan payable to a bank, due in monthly
installments of $3,848 plus interest at the
bank's prime rate (6% at December 31, 1997)
plus 1.50%, due May 1, 1998. The loans are
collateralized by Biopool Canada assets of
which the net book value exceeds the related
outstanding balance. $ 47 $ 163
BIOPOOL INTERNATIONAL
Term loan payable to a bank, due in monthly
installments of $72,795 plus interest at a
fixed rate of 8.77%, due January 2001,
collateralized by accounts receivable,
inventories, and property and equipment of
Biopool International. 2,698 3,500
Other 92 --
______ ______
Total 2,837 3,663
Less portion due within one year (964) (852)
______ ______
Long-term debt, net $1,873 $2,811
</TABLE>
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.
The term loans payable contain certain restrictions, including capital
expenditures and payment of dividends. The agreements also require the
Company to maintain certain financial ratios.
38
<PAGE>
Maturities of long-term debt for the five years succeeding December 31,
1997, are $964,000 in 1998, $918,000 in 1999, $882,000 in 2000, $73,000 in
2001, and none thereafter.
As of December 31, 1997, the Company had lines of credit totaling
$934,000, all of which were unused and available.
4. COMMITMENTS AND CONTINGENCIES
Leases
The Company leases certain equipment and facilities under non-
cancellable operating leases. Lease expense for 1997 and 1996 was
approximately $255,000 and $274,000, respectively. At December 31,
1997,approximate minimum annual lease commitments were $275,000 in 1998,
$272,000 in 1999, $158,000 in 2000, $155,000 in 2001, $73,000 in 2002, and
none thereafter.
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. Royalty expense amounted to $86,000 and $132,000 in
1997 and 1996, respectively.
Litigation
The business of the Company gives rise to routine litigation. In
management's opinion, there are no known actions or claims pending or
threatened at this time.
5. STOCK OPTION PLANS
The Company has two stock option plans (the "Plans") for the benefit of
employees, officers, directors, and consultants of the Company. Under the
Plans, a total of 2,282,549 shares of the Company's common stock were
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 the last trade value of the common stock on the
day preceding the date of grant. Options granted under the Plans generally
vest over a one- to four-year period from the date of the grant.
39
<PAGE>
<TABLE>
Stock option activity for 1995 through 1997 follows:
<CAPTION>
Weighted
Average
Shares Exercise
Outstanding Exercisable Price Range Price
_________________________________________________________________________
<S> <C> <C> <C> <C>
Balance at
December 31, 1995 1,061,782 443,888 $0.19 - 2.75 $1.26
Granted 594,657 1.44 - 3.13 1.99
Exercised (134,628) 0.19 - 1.44 1.13
Cancelled (236,700) 0.94 - 1.44 1.25
__________
Balance at
December 31, 1996 1,285,111 611,600 0.94 - 3.13 1.62
__________
Granted 270,163 2.28 - 2.68 2.46
Exercised (78,435) 0.94 - 1.44 1.15
Cancelled (66,018) 1.44 - 2.50 2.11
__________
Balance at
December 31, 1997 1,410,821 819,083 $0.94 - 3.13 $1.78
</TABLE>
At December 31, 1997, 556,280 shares were available for future grants
under the Plans.
As of December 31, 1997, the Company had 274,951 warrants outstanding
and exercisable for prices ranging from $1.875 to $3.00 with a weighted
average exercise price of $2.00 per share.
6. GEOGRAPHIC INFORMATION
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 1997 and 1996.
40
<PAGE>
<TABLE>
The consolidated financial statements include the following information
for Biopool Sweden, Biopool Canada, and Biopool International in thousands
of dollars.
<CAPTION>
Elimina-
Biopool Biopool Biopool tions and Consoli-
Sweden Canada International Corporate dated
___________________________________________________________________________
<S> <C> <C> <C> <C> <C>
1997
Sales $ 2,794 $ 1,602 $13,309 $(1,200) $16,505
Less intercompany (450) (545) (205) 1,200 --
_______ _______ _______ _______ _______
Sales to unaffil-
iated customers 2,344 1,057 13,104 -- 16,505
Net income 335 27 534 (53) 843
Identifiable assets 1,945 962 10,703 68 13,678
___________________________________________________________________________
1996
Sales 3,071 1,488 4,651 (1,190) 8,020
Less intercompany (544) (497) (149) 1,190 --
_______ _______ _______ _______ _______
Sales to unaffil-
iated customers 2,527 991 4,502 -- 8,020
Net income 435 93 483 284 1,295
Identifiable assets 2,298 1,160 3,306 6,359 13,123
___________________________________________________________________________
</TABLE>
Product sales to affiliates are generally priced at cost plus 30%.
<TABLE>
Information regarding the Company's sales by geographic locations is as
follows:
<CAPTION>
1997 1996
_______ _______
<S> <C> <C>
United States $10,372 $ 4,192
Western Europe 3,821 2,518
Asia/Pacific Region 796 438
Canada 505 240
Other 1,011 632
_______ _______
Total $16,505 $ 8,020
</TABLE>
41
<PAGE>
7. INCOME TAXES
<TABLE>
The provision for income taxes is composed of the following (in
thousands):
<CAPTION>
1997 1996
_____ _____
<S> <C> <C>
Current:
Federal - AMT $ 50 $ 21
State 76 43
Foreign 148 221
_____ _____
274 285
Deferred:
Reduction of valuation allowance (250) (400)
Other (36) --
_____ _____
Net benefit $ (12) $(115)
</TABLE>
<TABLE>
The reconciliation of income tax computed at the U.S. Federal Statutory
rates to the income tax provision is as follows:
<CAPTION>
1997 1996
_____ _____
<S> <C> <C>
Tax at U.S. statutory rate (34%) $ 283 $ 401
State income tax 76 43
Creation (utilization) of foreign
and U.S. net operating loss
carryforwards (281) (342)
Reduction of valuation allowance (250) (400)
Foreign taxes 148 221
Other 12 (38)
_____ _____
Net benefit $ (12) $(115)
</TABLE>
42
<PAGE>
<TABLE>
The components of the Company's deferred tax assets and liabilities at
December 31, are as follows:
<CAPTION>
1997 1996
_____ _____
<S> <C> <C>
Deferred tax assets:
Net operating loss carryforwards $ 534 $ 662
Other 152 59
_____ _____
686 721
Deferred tax liabilities:
Depreciation and amortization -- (57)
Foreign (108) (93)
_____ _____
(108) (150)
Valuation allowance -- (264)
_____ _____
Deferred taxes, net benefit $ 578 $ 307
</TABLE>
The valuation allowance decreased approximately $264,000 in 1997,
representing primarily the utilization of net operating loss carryforwards
and a $200,000 adjustment to reflect the estimated future benefit of the
net deferred tax assets remaining at year-end.
Biopool Sweden and Biopool Canada file separate income tax returns in
Sweden and Canada, respectively. At December 31, 1997, the Company had
available net operating loss carryforwards of approximately $1,571,000 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
approximately $510,000 and $748,000 at December 31, 1997 and 1996,
respectively.
Undistributed earnings of the Company's foreign subsidiaries amounted
to approximately $1,159,000 at December 31, 1997. Those earnings are
considered to be indefinitely reinvested and, accordingly, no provision for
U.S. federal and state income taxes has been provided thereon.
8. ACQUISITION
On January 1, 1997, the Company acquired certain assets of the Blood
Group Serology Division of Organon Teknika Corporation located in West
Chester, Pennsylvania, which manufactures and markets over 75 products used
by blood bank facilities to screen for specific antibodies and to group and
type whole blood, for $4,500,000 in cash. Another $229,000 of costs
associated with the acquisition were capitalized in the first nine months
43
<PAGE>
of 1997. The Company funded the acquisition, in part, from the privately
placed sale of 500,000 shares of its Common Stock to a group of accredited
investors and, in part, from the proceeds of a $3.5 million credit
facility. The acquisition was accounted for as a purchase.
<TABLE>
The following unaudited data was prepared for analytical purposes only.
Proforma consolidated operating results give effect as if the acquisition
occurred January 1, 1996.
<CAPTION>
Twelve Months Ended December 31,
1997 1996
_______ _______
(in thousands except share data)
<S> <C> <C>
Net sales $16,505 $15,981
Net income 843 1,545
Diluted earnings per share 0.09 0.17
</TABLE>
9. RETIREMENT PLAN
The Company has a defined contribution plan for its domestic
operations under which employees who have satisfied minimum age and service
requirements may defer compensation pursuant to Section 401(k) of the
Internal Revenue Code. Participants in the plan may contribute between 1%
and 12% of their pay, subject to the limitations placed by the IRS. The
Company, at its discretion, may match a portion of the amount contributed
by the employee. The Company contributed $141,000 and $15,000 in 1997 and
1996, respectively.
10. RESTRUCTURING CHARGES
In December 1997, the Company announced the restructuring of its
operations by closing its facilities in Canada and consolidating the
operations of its subsidiary, Biopool Canada, with its operations conducted
at the Company facilities in Ventura, California. The transition of the
technology and operations are expected to be completed by June 30, 1998. A
restructuring charge of $342,000 was recorded in the fourth quarter of 1997
to accrue for anticipated termination benefits ($111,000) for all twelve
employees and the writedown of certain inventory and fixed and intangible
assets. In addition, costs of approximately $100,000 are expected to be
incurred and expensed during the first six months of 1998 related to normal
transition activities.
44
<PAGE>
EXHIBIT 21
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
<TABLE> <S> <C>
<ARTICLE> 5
<S> <C>
<PERIOD-TYPE> YEAR
<FISCAL-YEAR-END> DEC-31-1997
<PERIOD-END> DEC-31-1997
<CASH> 1,376,000
<SECURITIES> 0
<RECEIVABLES> 2,758,000
<ALLOWANCES> 81,000
<INVENTORY> 3,784,000
<CURRENT-ASSETS> 8,123,000
<PP&E> 6,583,000
<DEPRECIATION> 2,398,000
<TOTAL-ASSETS> 13,678,000
<CURRENT-LIABILITIES> 2,652,000
<BONDS> 0
0
0
<COMMON> 86,000
<OTHER-SE> 8,959,000
<TOTAL-LIABILITY-AND-EQUITY> 13,678,000
<SALES> 16,505,000
<TOTAL-REVENUES> 16,505,000
<CGS> 10,023,000
<TOTAL-COSTS> 15,422,000
<OTHER-EXPENSES> (52,000)
<LOSS-PROVISION> 0
<INTEREST-EXPENSE> 304,000
<INCOME-PRETAX> 831,000
<INCOME-TAX> (12,000)
<INCOME-CONTINUING> 0
<DISCONTINUED> 0
<EXTRAORDINARY> 0
<CHANGES> 0
<NET-INCOME> 843,000
<EPS-PRIMARY> .10
<EPS-DILUTED> .09
</TABLE>
