UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 20-F
[ ] Registration statement pursuant to section 12(b) or (g) of the
Securities Exchange Act of 1934
or
[X] Annual report pursuant to section 13 or 15(d) of the
Securities Exchange Act of 1934
For the financial year ended December 31, 2002
or
[ ] Transition report pursuant to section 13 or 15(d) of the
Securities Exchange Act of 1934
For the transition period from ________ to ________
Commission file number 000-28966
Biacore International AB (publ)
(Exact name of Registrant as specified in its charter)
Kingdom of Sweden
(Jurisdiction of incorporation or organization)
Biacore International SA, Puits-Godet 12, CH-2000 Neuchatel, Switzerland
(Address of principal executive offices)
Securities registered or to be registered pursuant to Section 12(b) of the Act:
None
Securities registered or to be registered pursuant to Section 12(g) of the Act:
Title of Each Class Name of Each Exchange on Which Registered
Ordinary Shares of SEK 10 each The Nasdaq Stock Market
Securities for which there is a reporting obligation pursuant to
Section 15(d) of the Act:
None
Indicate the number of outstanding shares of each of the issuer's classes of
capital or common stock as of the close of the period covered by the annual
report.
Ordinary Shares of SEK 10 each.........................................9,750,000
Indicate by check mark whether the registrant (1) has filed all reports required
to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during
the preceding 12 months (or for such shorter period that the registrant was
required to file such reports), and (2) has been subject to such filing
requirements for the past 90 days.
Yes x No
Indicate by check mark which financial statement item the registrant has elected
to follow.
Item 17 x Item 18
TABLE OF CONTENTS
Introduction
Cautionary Statement Regarding Forward-Looking Statements
Part I
Item 1. Identity of Directors, Senior Management and Advisors
Item 2. Offer Statistics and Expected Timetable
Item 3. Key Information
A. Selected Financial Data
B. Capitalization and Indebtedness
C. Reasons for the Offer and Use of Proceeds
D. Risk Factors
Item 4. Information on the Company
A. History and Development of the Company
B. Business Overview
C. Organizational Structure
D. Property, Plant and Equipment
Item 5. Operating and Financial Review and Prospects
A. Operating Results
B. Liquidity and Capital Resources
C. Research and Development, Patents and Licenses, etc
D. Trend Information
Item 6. Directors, Senior Management and Employees
A. Directors and Senior Management
B. Compensation
C. Board Practices
D. Employees
E. Share Ownership
Item 7. Major Shareholders and Related Party Transactions
A. Major Shareholders
B. Related Party Transactions
C. Interests of Experts and Counsel
Item 8. Financial Information
A. Consolidated Statements and Other Financial Information
B. Significant Changes
Item 9. The [Offer and] Listing
A. [Offer and] Listing Details
B. Plan of Distribution
C. Markets
D. Selling Shareholders
E. Dilution
F. Expenses of the Issue
Item 10. Additional Information
A. Share Capital
B. Memorandum and Articles of Association
C. Material Contracts
D. Exchange Controls
E. Taxation
F. Dividends and Paying Agents
G. Statement by Experts
H. Documents on Display
I. Subsidiary Information
Item 11. Quantitative and Qualitative Disclosures About Market Risk
A. Foreign Currency Risk
Item 12. Description of Securities Other than Equity Securities
Part II
Item 13. Defaults, Dividend Arrearages and Delinquencies
Item 14. Material Modifications to the Rights of Security Holders and Use of
Proceeds
Item 15. Controls and Procedures
Item 16A. Audit Committee Financial Expert
Item 16B. Code of Ethics
Item 16C. Principal Accountant Fees and Services
Item 16D. Exemptions from the Listing Standards for Audit Committees
Part III
Item 17. Financial Statements
Item 18. Financial Statements
Item 19. Exhibits
Signatures
Certifications
INTRODUCTION
In this Annual Report references to "Biacore", the "Group" or "the
Company," except as the context may otherwise require, refer to Biacore
International AB (publ) including its consolidated subsidiaries. References to
"Pfizer" are to Pfizer Inc., its predecessors and its consolidated subsidiaries,
including Pharmacia Corporation and Pharmacia AB. However, regarding related
party transactions, references to Pfizer before January 1, 2003 relate only to
the Pharmacia Group, which was merged with Pfizer on April 16, 2003.
Biacore publishes its financial statements expressed in Swedish kronor
(SEK). In this Annual Report, references to "SEK" or "krona" are to the lawful
currency of Sweden and references to "USD" or "U.S. dollar" are to the lawful
currency of the United States. Solely for the convenience of the reader, this
Annual Report contains translations of certain SEK amounts into USD amounts at
specified rates. Unless otherwise stated, the translations of SEK into USD have
been made at the noon buying rate in New York City for cable transfers in SEK,
as certified for customs purposes by the Federal Reserve Bank of New York (the
"Noon Buying Rate") in effect on December 31, 2002, which was
USD 1 = SEK 8.6950. See Item 3A "Selected Financial Data - Exchange Rates" for
historical information regarding the Noon Buying Rate. Although the Swedish
krona is a convertible currency and Sweden currently has no or limited foreign
exchange restrictions, no representation is made that SEK have been, could have
been or could be converted into USD at the rates indicated or at any other rate.
All financial information in this annual report has been prepared in
accordance with accounting principles generally accepted in Sweden ("Swedish
GAAP"), unless otherwise stated. These accounting principles differ in certain
significant respects from accounting principles generally accepted in the United
States ("U.S. GAAP"). See Note 23 for a reconciliation of the principal
differences between Swedish GAAP and U.S. GAAP affecting Biacore's net income
and shareholders' equity.
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS
This annual report contains certain forward-looking statements within the
meaning of section 21E of the U.S. Securities Exchange Act of 1934, as amended,
and section 27A of the U.S. Securities Act of 1933, as amended, with respect to
certain of Biacore's plans and its current goals and expectations relating to
its future financial condition and performance.
Biacore may also make forward-looking statements in other written
materials, including other documents filed with or furnished to the U.S.
Securities and Exchange Commission (SEC). In addition, Biacore's senior
management may make forward-looking statements orally to analysts, investors,
representatives of the media and others. In particular, among other statements,
certain statements in this annual report with regard to customer demand, market
growth, competition, technology combinations, sales and other statements
relating to Biacore's future business development are forward looking in nature.
These forward-looking statements can be identified by the fact that they do not
relate only to historical or current facts. Forward-looking statements often use
words such as "anticipate," "target," "expect," "estimate," "intend," "plan,"
"goal," "believe," or other words of similar meaning.
By their nature, forward-looking statements involve risk and uncertainty
because they relate to events and depend on circumstances that will occur in the
future. Biacore's actual future results may differ materially from those set out
in Biacore's forward-looking statements. There are many factors that could cause
actual results and developments to differ materially from those expressed or
implied by these forward-looking statements. Any forward-looking statements made
by or on behalf of Biacore speak only as of the date they are made. Biacore does
not undertake to update forward-looking statements to reflect any changes in its
expectations with regard thereto or any changes in events, conditions or
circumstances on which any such statement is based. The reader should, however,
consult any further disclosures Biacore may make in documents it files with the
SEC, makes public or otherwise provides.
For a discussion of some of the factors that could cause actual results and
developments to differ, see Item 3D "Risk Factors."
PART I
ITEM 1. IDENTITY OF DIRECTORS, SENIOR MANAGEMENT AND ADVISORS
Not applicable
ITEM 2. OFFER STATISTICS AND EXPECTED TIMETABLE
Not applicable
ITEM 3. KEY INFORMATION
A. SELECTED FINANCIAL DATA
The following table sets forth selected financial data for Biacore for each
of the years in the five-year period ended December 31, 2002. The financial
statements of Biacore for each of the years in the three-year period ended
December 31, 2002 and as of December 31, 2000, 2001 and 2002 have been included
elsewhere herein. The selected financial data set forth in the following table,
other than "other data", are qualified by reference to these financial
statements of Biacore and the notes thereto, which have been audited by
PricewaterhouseCoopers AB, independent public accountants, or its predecessors.
The financial statements have been prepared in accordance with Swedish GAAP,
which differ in certain significant respects from U.S. GAAP. A discussion of
the principal differences between Swedish GAAP and U.S. GAAP as they relate to
Biacore are summarized in Note 23 of Notes to Financial Statements. The
following information should be read in conjunction with Item 5 "Operating and
Financial Review and Prospects" and the financial statements and the related
notes thereto included elsewhere herein.
Amounts are in thousands, As of and for the years ended December 31
except per share and other 2002 2002 2001 2000 1999 1998
data, unless otherwise USD (1) SEK SEK SEK SEK SEK
stated
Income statement data
Swedish GAAP
Sales 70,633 614,154 543,717 438,820 340,414 288,753
Cost of goods sold -11,608 -100,930 -99,800 -78,096 -66,213 -52,680
Marketing -22,981 -199,817 -188,696 -147,383 -113,994 -91,589
Administration -7,852 -68,271 -86,739 -60,827 -34,782 -41,960
Research and development -12,003 -104,370 -104,667 -72,760 -52,889 -48,719
Operating foreign currency
gains and losses -1,914 -16,644 4,539 3,167 2,206 3,525
Other operating income 2,413 20,982 742 9 32 1,289
Other operating expenses -1 -10 - - -253 -109
Amortization of goodwill -519 -4,515 -4,964 -4,956 -6,882 -5,716
Operating income 16,168 140,579 64,132 77,974 67,639 52,794
Gain on sale of
long-term investments - - 4,605 - - -
Write-downs of
long-term investments -3,296 -28,655 - - - -
Interest income 1,168 10,158 9,981 8,411 7,329 8,819
Interest expense -210 -1,833 -1,055 -1,054 -732 -821
Financial foreign currency
gains and losses -2 -16 199 1,326 991 -3,470
Other financial income
and expenses - - -5 - 34 -
Financial items, net -2,340 -20,346 13,725 8,683 7,622 4,528
Income after financial items 13,828 120,233 77,857 86,657 75,261 57,322
Income taxes -4,611 -40,096 -27,588 -27,536 -24,016 -17,624
Minority interest 71 623 - - - -
Net income 9,288 80,760 50,269 59,121 51,245 39,698
Diluted earnings per share 0.94 8.20 5.04 6.02 5.26 4.07
U.S. GAAP
Net income 8,585 74,644 51,262 75,024 49,090 23,787
Diluted earnings per share 0.88 7.66 5.23 7.67 5.03 2.44
Sales by region
Americas 31,113 270,524 249,347 191,872 141,199 125,990
Europe 19,999 173,894 151,004 139,152 116,203 92,099
Asia-Pacific 19,521 169,736 143,366 107,796 83,012 70,664
Total sales 70,633 614,154 543,717 438,820 340,414 288,753
Financial structure
Swedish GAAP
Operating capital 37,655 327,410 336,476 188,294 207,247 142,568
Long-term investments 911 7,920 40,470 68,025 17,214 9,750
Net interest-bearing assets 36,106 313,938 193,058 243,582 212,748 221,406
Net payable and deferred
income tax liability -1,581 -13,745 -769 -5,770 -8,069 -7,247
Minority interest -98 -853 - - - -
Shareholders' equity 72,993 634,670 569,235 494,131 429,140 366,477
Total assets 95,622 831,431 730,934 643,769 569,985 520,874
Number of shares, thousands 9,750 9,750 9,750 9,750 9,750 9,750
Average number of shares,
diluted, thousands 9,851 9,851 9,981 9,817 9,750 9,750
U.S. GAAP
Shareholders' equity 70,972 617,099 556,227 478,980 398,654 339,315
Other data
Operating margin, % 22.9 22.9 11.8 17.8 19.9 18.3
Return on operating capital, % 42.4 42.4 24.4 39.4 38.7 35.5
Return on equity, % 13.4 13.4 9.5 12.8 12.9 11.6
Interest coverage, times 66.0 66.0 74.4 83,2 103.8 14.4
Equity ratio, % 76.4 76.4 77.9 76.8 75.3 70.4
Capital expenditures 3,653 31,764 39,979 14,236 22,922 11,245
Dividend per share 0.35 3.00 - - - -
Average number of employees (2) 319 319 269 212 183 161
(1) Solely for the convenience of the reader, SEK amounts have been translated
into USD at the Noon Buying Rate on December 31, 2002 of
USD 1 = SEK 8.6950. Such translated amounts are unaudited.
(2) Average number of employees is calculated by dividing the total number of
hours worked at Biacore during the year by the number of working hours
constituting a full-time working year.
FINANCIAL DEFINITIONS
Basic earnings per share Net income divided by the average number of shares
(including shares represented by ADSs) issued and
outstanding during each year.
Capital expenditures Investments in tangible fixed assets, such as
buildings, land, land improvements, machinery and
equipment.
Diluted earnings per share Net income divided by the average number of shares
(including shares represented by ADSs) during each
year. The average number of shares has been
calculated using the treasury stock method to
account for options outstanding. In accordance with
Swedish GAAP, proceeds from issuance of stock at
exercise of options have been discounted to present
value. In accordance with U.S. GAAP, such
discounting has not been performed in calculating
diluted earnings per share according to U.S. GAAP.
Equity ratio Shareholders' equity and minority interest, divided
by total assets.
Interest coverage Income before expenses for interest-bearing
liabilities, divided by expenses for
interest-bearing liabilities.
Net interest-bearing assets The net balance of interest-bearing assets and
liabilities, including pension liabilities.
Net payable and deferred The total of income taxes payable and provisions
income tax liability for deferred taxes, less the total of income tax
receivables and deferred tax assets.
Operating capital The net balance of assets and liabilities except
for; long-term investments, net interest-bearing
assets, and net payable and deferred income tax
liability.
Operating margin Operating income divided by sales.
Return on equity Net income divided by average shareholders' equity.
Return on operating capital Operating income divided by average operating
capital.
EXCHANGE RATES
During the last five years, the exchange rates for the U.S. dollar against
the Swedish krona based on the Noon Buying Rate have been as follows.
SEK per USD Average rate (1)
1998 7.9658
1999 8.3007
2000 9.2200
2001 10.4328
2002 9.6571
(1) The average of the Noon Buying Rates on the last business day of each full
month.
Since December 2002, the monthly high and low Noon Buying Rates have been
as follows.
SEK per USD High Low
2002, December 9.0750 8.6950
2003, January 8.7920 8.4750
2003, February 8.5650 8.4100
2003, March 8.7030 8.3650
2003, April 8.6425 8.1700
2003, May 8.1470 7.7479
On December 31, 2002 and June 2, 2003, the Noon Buying Rate was SEK 8.6950
and SEK 7.7730 per USD, respectively.
B. CAPITALIZATION AND INDEBTEDNESS
Not applicable.
C. REASONS FOR THE OFFER AND USE OF PROCEEDS
Not applicable.
D. RISK FACTORS
Prior to making any investment or other significant decision relating to
Biacore, one should carefully consider the risks and uncertainties described
below in addition to other information presented in this annual report.
Additional risks and uncertainties that do not currently exist, that we are
unaware of or that we currently believe are immaterial may also become important
factors that adversely affect Biacore and yourself.
Technological Change
The business environment in which Biacore operates, including Surface
Plasmon Resonance (SPR) based systems that measure interactions between
biomolecules and other biotechnologies, is characterized by extensive
technological change, which is expected to continue at a rapid pace. Existing
and potential competitors are investing substantial amounts of resources in
research and development. There can be no assurance that developments by others
will not limit Biacore's ability to expand its business or render Biacore's
technologies, products and services obsolete or uneconomical.
Research and development projects are subject to high risk. They generally
relate to issues which have not been thoroughly investigated before. Unexpected
problems often appear, and research and development projects are sometimes
discontinued for lack of success.
Rapid technological change and other technological issues make future
planned product introductions uncertain. Lack of successful new product
introductions may have a material adverse effect on Biacore's financial
condition and results of operations.
In order to acquire patents and otherwise maximize the advantage of new
knowledge, Biacore may, during a certain period and to the extent allowed by
law and regulation of financial markets, abstain from making public new research
and development findings.
The extent to which Biacore can advance its technology and competitive
position depends to a significant extent on its ability to enter and
successfully complete partnerships and other collaborations. The outcome of such
arrangements depends on various factors, many of which are not controlled by
Biacore.
Patents and Proprietary Technologies
Biacore's future development depends to a large extent on its ability to
develop proprietary products and technologies, and to establish and protect its
existing and future patents and other rights. The patent positions of
technology-based companies, including Biacore, involve complex legal and factual
questions and may be uncertain, and the laws governing the scope of patent
coverage and the periods of enforceability of patent protection are continuing
to evolve. In addition, patent applications in certain jurisdictions are
maintained in secrecy until patents are issued, and publication of discoveries
tend to lag behind actual discoveries. Therefore, no assurance can be given that
patents will be issued from any patent application owned by or licensed to
Biacore or, if patents are issued, that the rights granted will be sufficiently
broad to protect Biacore's technology. In addition, no assurance can be given
that any issued patent owned by or licensed to Biacore will not be challenged,
invalidated or circumvented, or that the rights granted thereunder will provide
competitive advantages to Biacore.
Biacore also relies on trade secrets and proprietary know-how, which it
generally seeks to protect through confidentiality agreements with its employees
and consultants. There can be no assurance that these agreements will not be
breached, that Biacore would have adequate remedies for any breach or that
Biacore's trade secrets will not otherwise become known or be independently
developed by competitors.
Litigation or other proceedings for intellectual property rights
infringement may require Biacore to spend time and money on such proceedings,
may delay development and commercialization of new or existing technologies and
products and, if the outcome of the proceedings are unfavorable to Biacore, may
force Biacore to pay damages.
Collaborations
Biacore currently engages in, and from time to time may engage in,
collaborations with academic researchers, institutions, pharmaceutical and
biotechnology companies, and others. There can be no assurance that under the
terms of such collaborations, third parties will not acquire rights in certain
inventions developed during such collaborations.
Competition and Potential Limitations on Growth
Biacore faces competition both directly from other manufacturers of
instruments that use SPR or similar technologies and indirectly from other
technologies that have certain applications in common with Biacore's products
and services. Biacore expects to face increased competition in the future,
leading to a reduction of Biacore's rate of growth, market share and operating
margin. There can be no assurance that Biacore will be able to develop or
enhance its products to compete successfully with new or emerging technologies.
Customer Demand
The life science research market has grown over many years. While Biacore
currently expects this market to continue to grow, market growth is difficult to
predict. The development of biotechnology has not progressed as rapidly as many
had predicted and the pace of development may be slowing down. Factors such as
the already high level of mergers in the pharmaceutical industry, with research
laboratories being combined and rationalized, are believed to limit market
growth and may reduce demand. During the first quarter of 2003, Biacore's sales
fell by 25% compared with the first quarter of 2002. See also the next two
subsections "Funding of Customers" and "High Fixed Costs, Dependence on
Individual Orders, Seasonality and Limited Forecasts," and Note 22 of Notes to
Financial Statements.
Funding of Customers
Currently, approximately 55% of Biacore's products are sold to academic or
government research laboratories, private research foundations and other
institutions, the funding of which may depend on grants from government
agencies. Research funding by governments is subject to political risk,
including competition from other technologies as they become available. In
addition, government budgets for research funding in all countries may be
subject to general political trends and changes in economic growth and
government finances, calling for reduced governmental expenditures. Reduction in
governmental funding for research or deferral of the availability of such
funding may materially affect the ability of Biacore's prospective customers to
acquire Biacore's products, which may have a material adverse effect on
Biacore's financial condition and results of operations.
High Fixed Costs, Dependence on Individual Orders, Seasonality and Limited
Forecasts
Substantial gross margins and a high proportion of relatively fixed
research and development, marketing and administration expenses make Biacore's
net income highly dependent on variations in sales. Any slow-down in sales could
have a material negative impact on net income.
Each analytical system that Biacore markets has a high unit value and the
number of analytical systems sold is comparatively small. This makes analysis of
changes in trends more difficult and increases uncertainty relating to future
sales during individual periods.
Historically, Biacore has had approximately 30 to 40% of annual sales in
the fourth quarter of each year. Combined with high fixed costs and significant
dependence on individual orders, the strong seasonality of sales has caused
operating income to vary substantially between different quarters and made
forecasts of annual sales and income highly uncertain.
Sales within each quarter have often been higher in the third than in the
first and second months.
As a result of these factors, Biacore has often not published any forecast
of income, has only provided limited indications of future sales and in the
future may not provide any forecast at all.
Fluctuations in sales and income could affect the market price of the
Shares or ADSs in a manner unrelated to the longer-term operating performance of
Biacore.
Potential Adverse Effect of Exchange Rate Fluctuations
Approximately 97%, 99% and 97% of Biacore's sales in 2000, 2001 and 2002,
respectively, were derived from customers located outside Sweden and were
generally denominated in currencies other than the Swedish krona, including the
U.S. dollar, the Japanese yen, the euro and the British pound. Production and
research and development are mainly carried out in Sweden. Therefore, Biacore
has larger expenses than revenues denominated in Swedish kronor. As a result,
appreciation of the Swedish krona would tend to reduce Biacore's operating
income margins.
Taxation
The interpretation of tax laws involves judgement. It is therefore common
for tax experts not to provide firm opinions. Management may then rely on
indications from tax experts, and management's own understanding of complex and
subjective tax issues. Conditions under which taxes have been calculated may
turn out not to have been fulfilled and actual taxes for past periods may be
different from those estimated and accrued for.
Acquisitions and Joint Ventures
Biacore's plan for growing its business includes not only organic growth but
also the possibility of acquisitions and joint ventures. The process of
integrating an acquired or co-managed business, project, technology, service or
product may result in unforeseen difficulties, expenses and dilution of existing
investors' ownership. Furthermore, acquisitions generally lead to reduction of
liquid funds, increased debt, increased goodwill or other intangible assets,
increased amortization of intangible assets and, therefore, substantially
increased financial risk.
Dependence on a Single Manufacturing Facility
The vast majority of manufacturing activities performed by Biacore
currently take place in a single facility located in a single building in
Uppsala, Sweden. A single serious incident, such as a fire, could result in
significant interruption of production and result in loss of sales, which could
adversely affect Biacore's financial condition and results of operations.
Dependence on Certain Sources of Supply
Biacore purchases components and other materials from a limited number of
suppliers on a just-in-time basis. Certain components are only available from a
single supplier. From time to time, suppliers may cease operating, extend lead
times, limit supply to Biacore or increase prices due to capacity constraints,
fires or other factors, which may adversely affect Biacore's financial condition
and results of operations.
Key Personnel
Biacore relies upon a number of key executives and employees, including the
President of Biacore. The loss of services of any of Biacore's key executives or
employees could have a material adverse effect on its financial condition and
results of operations.
Ability to Attract and Retain Skilled Staff
The high technology and continuously rapid changes necessary to be able to
satisfy the requirements of Biacore's existing and potential new customers put
high demands on Biacore being able to attract and retain highly competent staff,
both in scientific, product development, marketing, management and other
functions. Biacore attempts to attract and retain key staff by offering
challenging career opportunities, a professional company culture and competitive
financial compensation. However, applicable markets for employees with relevant
skills are very tight. The general unemployment rate in the Stockholm/Uppsala
area, where most of Biacore's research and development, production and certain
other functions are located, is approximately 3.3%. The corresponding
unemployment rate for skilled scientists, relevant engineers and other key
personnel is believed to be even lower. In a high technology industry such as
Biacore's, any failure to attract and retain highly skilled staff could have a
material adverse effect on its financial condition and results of operations.
Control by Principal Shareholder
Pfizer owns approximately 41% of Biacore. As a result, it is in a position
to exercise significant influence over matters put to a vote of shareholders,
including the election of Biacore's directors. Pfizer's interests may differ
from those of other investors.
Limited Trading of American Depositary Shares
Although Biacore has had American Depositary Shares listed on Nasdaq
National Market since 1996, the frequency and amount of trading of ADSs has been
limited. Biacore's ordinary shares are listed on the Stockholm Stock Exchange.
Trading of Biacore's ordinary shares in that market is relatively active. ADSs
in Biacore may, under certain circumstances and against a certain charge, be
converted to ordinary shares listed on the Stockholm Stock Exchange.
Correspondingly, ordinary shares listed on the Stockholm Stock Exchange may,
under certain circumstances and against a certain charge, be converted to ADSs
listed on Nasdaq National Market.
Net Assets per Share
Shareholders' equity per share and net tangible book value per share are
substantially below current stock market prices.
Stock Options
At December 31, 2002, Biacore International AB had 760,000 long-term stock
options outstanding, of which 696,575 were also outstanding in the consolidated
accounts. These stock options are exercisable at prices between SEK 244 and
SEK 363. The options are exercisable, and any new shares issued therefore
payable, between May 2006 and May 2011. Although exercise of these stock options
may increase shareholders' equity per share and/or net tangible assets per
share, the possibility of such exercise may have a dilutive effect on earnings
per share. See also Notes 20, 22 and 23 of Notes to Financial Statements.
Accounting standards, policies and issues
Accounting standards and policies are subject to interpretation and
continuous change. Currently reported financial statements may be restated in
the future as an effect of e.g. changes in accounting standards. Accounting
policies and issues that Biacore currently believes involve significant
uncertainty include research and development, impairment of intangible assets,
incentive stock options and deferred tax assets. See also Item 5A "Operating
Results - Important Accounting Policies and New Accounting Standards."
The preparation of financial statements 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 dates of
the financial statements and the reported amounts of revenues and expenses
during the reporting periods. Actual results could differ from those estimates.
Item 4. INFORMATION ON THE COMPANY
A. HISTORY AND DEVELOPMENT OF THE COMPANY
LEGAL ENTITY
The legal and commercial name of the Company is Biacore International AB
(publ). It is domiciled in Sweden, was incorporated as a limited liability
corporation ("aktiebolag") in 1996 under the Swedish Companies' Act
("Aktiebolagslagen"), acts as a holding company and has no operating revenue of
its own apart from sales of services to other group companies. The registered
office address is Rapsgatan 7, 754 50 Uppsala, Sweden, the website is
www.biacore.com and the telephone number is +46 18 675700.
IMPORTANT EVENTS IN THE DEVELOPMENT OF THE COMPANY'S BUSINESS
Biacore began developing its SPR-based technology in 1984, when expertize
and know-how from several independent research activities were collected within
Biacore International AB's predecessor, Pharmacia Biosensor AB. In 1990, the
first commercial product was sold. In 1996, Pfizer (Pharmacia) incorporated
Biacore International AB and made it the new holding company of the Biacore
Group. Later in 1996, Pfizer (Pharmacia) divested 59% of the Company and Biacore
was listed on the O-list of the Stockholm Stock Exchange and Nasdaq National
Market in the United States.
During 2002, Biacore moved its headquarters from Uppsala, Sweden to
Neuchatel in Switzerland. The domicile and principle place of operations remains
Uppsala, Sweden.
One of Biacore's most important current projects relates to the development
of SPR array technology, which Biacore currently expects to lead to the launch
of a commercial product based on this technology in approximately 2004. Biacore
believes that such a product would be of particular use within the drug
discovery sector.
PRINCIPAL CAPITAL EXPENDITURES AND DIVESTITURES
During 2000, 2001 and 2002, annual capital expenditures on machinery and
equipment were SEK 14 million, SEK 31 million and SEK 15 million, respectively.
During the same period, SEK 0 million, SEK 9 million and SEK 17 million were
invested in buildings, mainly offices in Uppsala.
Investments in intangible assets amounted to SEK 0 million, SEK 58 million
and SEK 7 million in 2000, 2001 and 2002, respectively. Of the amount in 2001,
USD 5 million (SEK 53.6 million) related to the acquisition of a license from
Axiom Biotechnologies Inc. ("Axiom") (see Notes 2 and 5 of Notes to Financial
Statements). Of the amount in 2002, SEK 5.0 million related to capitalized
product development (see notes 1 and 5 of Notes to Financial Statements).
In 2000, SEK 51 million was invested in the acquisition of long-term
investments in closely related technology ventures. In 2001, Biacore received
SEK 32 million from the sale of long-term investments, which related to the sale
of 1,000,000 shares in Axiom to Axiom for USD 3 million. The two transactions
with Axiom in 2001 referred to in this and the prior paragraph were negotiated
simultaneously and the payments of USD 5 million to Axiom and USD 3 million from
Axiom were netted. In 2002, the remaining shares in Axiom were exchanged for
shares in Sequenom, Inc. (see also Note 7 of Notes to Financial Statements).
Biacore currently has no significant capital expenditure or divestment in
progress except as set forth in Item 4D "Property, Plant and Equipment." See
also Item 5B "Liquidity and Capital Resources."
B. BUSINESS OVERVIEW
GENERAL
Biacore's business mainly relates to the commercialization of surface
plasmon resonance (SPR) technology, which is used for the real-time detection
and monitoring of biomolecular binding interactions. Identifying and
characterizing the sometimes small changes in the way biomolecules interact can
increase understanding of the causes of disease as well as the differences in
the effectiveness of different drug therapies.
Biacore has a well-balanced customer base, which includes well-known life
science research institutes, pharmaceutical and biotechnology
companies and food manufacturers.
THE CORE LIFE SCIENCE RESEARCH BUSINESS
Recently, Biacore's focus has been to maximize the potential of its SPR
technology to improve the overall economics of the drug discovery and
development process. This process relies on important discoveries being made by
researchers in academic life science laboratories as well as in the
pharmaceutical and biotechnology industry.
The important role of these major academic and government funded
laboratories is the key reason that Biacore focuses its marketing and product
development activities on this important customer group. Biacore believes that
its SPR technology can make an important contribution to developing a more
comprehensive understanding of the molecular causes of disease. This is an
important step in the search for novel medicines that generate better clinical
outcomes with lower side effects. Biacore believes that the ability to generate
medicines with these improved characteristics is important if the pharmaceutical
industry is to resume its previous growth.
A NICHE TECHNOLOGY SUPPLIER TO THE LIFE SCIENCE MARKET
Biacore is still a niche player in the global life science research market.
In 2002, the overall market for instruments supplied to life science customers
was estimated to be worth USD 20.5 billion (Instrument Business Outlook,
December 2002). In recent years, this market has been growing at approximately
10% per annum, although the estimated growth slowed somewhat in 2002.
The biggest consumers of life science instrumentation are pharmaceutical
and biotechnology companies, and government and academic institutions involved
in life science and pharmaceutical research and development.
In 2002, this R&D focused customer group accounted for an estimated 44% of
the overall market with a total value of USD 9 billion. This is the key market
segment for Biacore, with more than an estimated 80% of Biacore's SPR technology
systems being sold to this important customer group. The other key areas where
Biacore's technology is beginning to develop more of a profile is in analytical
services and quality control (QC).
Other techniques that form a significant element of the overall life
science instrumentation market are chromatography including high pressure
liquid chromatography (HPLC) and gas chromatography (GC), bioinstrumentation
including DNA synthesizers and sequencers as well as electrophoresis equipment
and mass spectrometry.
The historically attractive rate of growth of the life science
instrumentation market, relative to the growth in overall economic activity, has
been driven by an increasing desire by both governments and private sector
companies to invest in basic life science research. This investment allows them
to benefit from the significant advances that have been made in molecular
biology to elucidate the human genome and gain insight into the mechanisms of
disease at a molecular level. This research is expected, in time, to lead to the
development of better medicines and improved human health.
Due to the overall size of the life science research market, Biacore
believes that there is considerable scope for growth. Another factor that
supports Biacore's growth prospects is the limited competition that it faces.
Although there are a number of other companies involved in supplying SPR based
systems to the life science market, to-date these have largely been lower priced
systems that are often unable to produce the reproducible and high-quality data
needed by researchers. Such data is often available by using Biacore's systems.
The major short-term risks that Biacore faces in terms of the life science
research market revolve around funding. These include:
- Changes in the amounts and availability of funds as a result of changes in
economic growth and government finances.
- Competition from other 'hot' technologies for funds.
Biacore's global reach means that its geographic diversity helps shelter it
from changes to the market dynamics in individual regions.
UNDERSTANDING THE MOLECULAR BASIS OF DISEASE
Building better insights into the molecular basis of disease and normal
processes within biological systems drives much of the research currently
undertaken in well known life science research laboratories. These include the
National Institutes of Health (NIH), the Ludwig Institute (LICR), the National
Cancer Institute (NCI) and the Imperial Cancer Research Fund (ICRF) as well as
the major pharmaceutical and biotechnology companies.
These research institutions are key customers for Biacore's SPR technology,
which offers the ability to generate unique real-time functional data on
biomolecular interactions in biological systems often involving samples that
might be too crude, too small or too low in affinity for other technologies to
handle.
This high quality data allows scientists to develop a better understanding
of biological systems. Based on such improved understanding and that of disease
processes, scientists are able to make better decisions about which new drugs to
develop.
The growing recognition of the value of the data generated by Biacore's
SPR based systems is reflected in the fact that there have been more than 2,900
citations of Biacore's technology in research papers. These papers have focused
on a wide range of applications, including key areas of life science research
such as cancer, neuroscience, immunology, infectious diseases and proteomics.
SPR TECHNOLOGY - AN IMPORTANT PROTEOMICS TECHNOLOGY
The sequencing of the human genome in 2001 resulted in a wealth of new
genetic information becoming available to researchers. Biacore believes that the
unraveling of the information on the proteins that are derived from these gene
sequences, the study of which is called proteomics, is important to developing
the new medicines of the future.
There are two key areas of the high growth proteomics research market,
protein mapping and functional proteomics.
PROTEIN MAPPING
Unlike the genome, the proteome (protein complement of the genome) is
constantly changing in response to a cell's environment. By comparing the
proteome under varying conditions, researchers have the means to identify key
proteins involved in a disease process, which may have potential as new targets
for therapeutic intervention.
Protein mapping demands technologies capable of analyzing the protein
content of whole cells or tissues. In recent years, two core tools have been
used in this area, two-dimensional (2-D) gel electrophoresis and mass
spectrometry (MS).
Two-dimensional gel electrophoresis is used for separating proteins
according to their charge and size, and can separate up to 10,000 distinct
proteins and peptide spots in one gel. Using MS, it is possible to characterize
proteins according to their mass and peptide sequence.
However, protein mapping, which is focused on the detection, separation and
characterization of proteins, is not an end in itself. Simply knowing that a
particular protein of known mass and amino acid sequence is more abundant in
e.g. a cancer cell compared with a healthy cell, does not necessarily contribute
to understanding what has caused the cancer and how it could be cured.
It is important to understand the protein's function in the cell, whether
it is involved in the disease process, and whether its activity can be altered
by targeted drug design. Generating this information is called functional
proteomics.
FUNCTIONAL PROTEOMICS
The functional proteomics market represents an important opportunity for
Biacore, given that the function of a significant proportion of the proteins
found in humans is unknown. The study of the function of a protein currently
fucuses on establishing the interactions of that protein with other molecules,
something to which Biacore's SPR technology is well suited. A key advantage of
Biacore's SPR technology is that nearly all of the data is generated using
proteins in their native state, and it is important when conducting studies
with proteins to conserve their complex, native three-dimensional structure, as
this structure dictates the proteins' in vivo function.
Proteins do not work in isolation but form complexes with other molecules
within the cell and on the cell membrane. The cell's communication systems are
based around these interactions and even small changes in protein structure
and/or abundance can have significant consequences on disease initiation and
progression.
SPR technology identifies binding partners to a novel protein and
researchers can begin to unravel the pathways in which the protein is involved
via a process called ligand fishing. Ligand fishing is a key application of
Biacore's SPR technology and is an essential element of functional proteomics,
as it links a receptor of potential disease or therapeutic interest to a
chemical structure (ligand) that might form the basis of a new pharmaceutical
product.
Biacore's SPR technology has a number of advantages when it is used for
ligand fishing. These include:
- The ability to screen complex mixtures as a source of ligands with only
minimal sample preparation.
- The ability to repeat consistently these experiments due to Biacore's
microfluidics systems.
- The high sensitivity of Biacore's systems, which makes them particularly
suitable for finding chemical structures (molecules) that only bind with
low affinity to the proteins of interest.
Given the potential size of this market and the ability of Biacore's SPR
technology to help unravel this functional information, proteomics has been a
key marketing focus for the Company's life science research business unit.
IDENTIFICATION COMBINED WITH FUNCTION - THE COLLABORATION WITH BRUKER DALTONICS
In October 2001, Biacore signed a collaboration agreement with Bruker
Daltonics Inc. (BDAL), designed to combine the two companies' core technologies,
SPR and mass spectrometry, respectively.
Together, the companies aim to commercialize the combined technique of
SPR-MS in order to create a comprehensive technical solution for functional
proteomics studies. This new combined approach will help researchers to:
- Generate functional information on proteins, receptors and ligands of
interest.
- Isolate and purify these molecules.
- Identify and characterize these proteins or other molecules of interest.
A growing number of customers have begun to explore this technology
combination across an array of applications in areas as diverse as cancer
research, plant biology and product quality assurance. With the continuing
collaboration, the increased understanding of the methodology has led to a
number of new applications.
In response to the need for more automated and larger capacity recovery, as
well as the ability to directly deposit targets to a MALDI (Matrix-Assisted
Laser Desorption Ionization), Biacore has in March 2003 launched a new module
for Biacore(r)3000 which will further enhance and integrate the SPR-MS approach.
Biacore believes that the SPR-MS technology combination will provide
researchers with a new approach to functional proteomics studies and
will give both companies a significant competitive position in the proteomics
market.
In August 2002, Biacore and the U.S. company Intrinsic Bioprobes Inc.
started a complementary strategic collaboration aimed at combining SPR and
MALDI TOF (Matrix-Assisted Laser Desorption Ionization - Time of Flight) mass
spectrometry. Through this collaboration, researchers are expected to be able to
quickly screen protein-protein interactions and study protein information
combined with information on the structure of interacting substances.
OUR PHARMACEUTICAL AND BIOTECHNOLOGY BUSINESS
In addition to providing insights into the molecular causes of disease,
Biacore's SPR technology is used in the discovery and development of
new medicines.
A key attribute of SPR technology is that it provides pharmaceutical and
biotechnology companies with the ability to discover and develop new drugs more
economically. This economic benefit derives from the technology's ability to
generate high-quality data, that allows more informed decisions to be taken
earlier about which targets to focus on or which drug candidates to develop.
Biacore has been working over the last three years to further develop its
business with this important customer group. This has involved the introduction
of a range of systems, which are designed to overcome bottlenecks faced by the
pharmaceutical industry in the development of new pharmaceutical products.
THE OVERALL PHARMACEUTICAL RESEARCH MARKET
In 2001, the global pharmaceutical and biotechnology industries investment
in research and development was estimated to be in excess of USD 70 billion,
with half of this expenditure taking place in the U.S. Within this figure,
Biacore's systems are targeted at a market estimated to be worth USD 8.5 billion
in 2001 (High Tech Business Decisions 2002). This expenditure covers both
biological testing and pharmacology screening.
SPR SOLUTIONS TO THE PHARMACEUTICAL INDUSTRY
A key element of Biacore's strategy to extend its pharma/biotech business
has been to develop new systems that tackle some of the problems that slow the
flow of new medicines to the market. A number of these problems have arisen from
the adoption of technologies such as combinatorial chemistry and high throughput
screening, and include:
- Target identification and validation. This is an important step prior to
starting the High Throughput Screening (HTS) of chemical libraries. In
order to screen these libraries for the most appropriate new molecules for
further development, it is vital that the target being screened is actually
of value as a potential point of therapeutic intervention.
- Assay development and validation for HTS. In order for HTS to actually find
molecules of value, the assays used in these high throughput screens must
reflect accurately the target that any future drugs will be developed
against.
- Lead optimization and secondary screening. Once a 'hit' has been achieved
during HTS, the molecule has to be optimized in terms of its activity, in
order to generate the best medicine possible. In addition, other
characteristics of the molecule have to be investigated to assess their
impact on the effectiveness of the drug when given to humans.
In addition to developing market-focused instrument systems, Biacore has
recruited a team of personnel who are highly experienced in marketing high-end
drug discovery and development technologies to the pharmaceutical and
biotechnology industry.
Biacore(r)3000 provides high-quality binding data that can be used to
determine the most appropriate targets within a biological system, against which
new drugs can be developed. In addition, once the most suitable target has been
identified, this same system can also be used to develop and optimize the assays
needed to run the HTS process.
ENHANCED SECONDARY SCREENING OFFERING
In late 2001, Biacore introduced its first system specifically designed for
the pharmaceutical and biotechnology industry. The new Biacore(r)S51 addresses
important bottlenecks in the drug discovery process downstream of HTS. Biacore
believes that Biacore(r)S51 provides more relevant biological information on
compound activity, in a single assay, than any other technology available today.
One of the rate limiting steps in developing drugs faster is the conversion
of 'hits', which have been generated from HTS, into lead compounds for
pre-clinical evaluation. Biacore(r)S51 can rapidly and efficiently address the
key steps in the 'hit'-to-lead selection process, by combining the advantage of
Biacore's SPR technology with advanced instrumentation and software, which
result in higher throughput, enhanced data quality and reduced sample usage.
Specifically, Biacore(r)S51 provides data-rich analysis in four important
stages of the drug discovery and development process. These are:
- Rapid confirmation of HTS 'hits'.
- Comprehensive kinetic characterization of potential lead compounds.
- Detailed kinetics based QSAR (quantitative structure activity relationship)
to drive lead optimization.
- Rapid in vitro early ADME (absorption, distribution, metabolism and
excretion) analysis to maximize lead selection criteria and define likely
in vivo behavior.
An important aspect of pharmaceutical development is to pick up problems
early so that resources can be redirected to molecules with a better chance of
reaching the market, and by using Biacore's SPR technology in the areas
mentioned above the technology can contribute to this.
Sales of Biacore(r)S51 have been made to well-known pharmaceutical and
biotechnology companies around the globe. Given the progress that has been made
with Biacore(r)S51 since its launch, Biacore believes that this type of system
can be an important contributor to its sales. In addition, new
customer-generated data highlighting the benefits of using Biacore(r)S51 is
expected to become increasingly available during the course of 2003, and new
applications for the Biacore(r)S51, particularly in the area of structure
activity relationships, based on the work of university research scientists,
have occurred.
PROCEL(tm) - A NOVEL COMPLEMENTARY CELL-BASED ASSAY FOR SECONDARY SCREENING
In late 2002, Biacore introduced its new cell-based assay system,
Procel(tm). This product has resulted from Biacore acquiring a license to
proprietary fluorescent cell-based assay technology developed by the U.S.
company Axiom Biotechnologies Inc.
Procel(tm), which had its full commercial launch in March 2003 at the
Screentech Conference in San Diego, is designed to complement Biacore(r)S51 and
provide a competitive offering in the field of lead optimization. By using
Procel(tm), researchers will have access to an easy-to-use cell-based
fluorescent analytical system which has been designed to characterize compounds
that interact with both G protein coupled receptors (GPCRs) and ion channels.
These are two of the main classes of drug targets under evaluation today.
Procel(tm) is able to carry out a number of important cell-based
applications which are important in the lead optimization process, including hit
verification, automated hit profiling and Schild analysis, as well as a number
of other pharmacological parameters.
Biacore believes that the combination of Procel(tm) and Biacore(r)S51 will
provide researchers with access to detailed information on the biological
activity of potential drug candidates in a competitive timeframe and to a depth
and quality superior to existing analytical instrumentation. It also expects the
complementary nature of these two products to lead to synergies in Biacore's
sales and marketing efforts.
THE PHARMACEUTICAL/BIOTECHNOLOGY INDUSTRY NEED FOR NOVEL QC SOLUTIONS
Biacore introduced its second system specifically for the pharmaceutical
and biotechnology industry in late 2001. The new system, called Biacore(r)C, is
designed for rapid concentration analysis of bio-therapeutics in drug
development, manufacturing quality control (QC) and in-process control
applications. Biacore(r)C is the first SPR-based system for QC applications
designed for compliance with pharmaceutical regulatory requirements. The
pharmaceutical industry is coming under increasing regulatory scrutiny at a time
when it is striving to bring new pharmaceutical products to the market faster.
The regulatory authorities are becoming more and more focused on ensuring that
companies are in strict compliance with Good Laboratory Practice (GLP) / Good
Manufacturing Practice (GMP), leading to the fact that the validation of
analytical systems and procedures is becoming a major rate-limiting step.
Biacore(r)C was specifically developed within a Good Automation
Manufacturing Practice (GAMP) model, with regulatory requirements in mind, and
Biacore expects that it will reduce the time for biomolecular analysis while
meeting high demands for accuracy, sensitivity and reproducibility.
The overall package offered by Biacore(r)C is designed to make it easier
for users to provide the regulatory authorities with the data needed to comply
with the strict guidelines that cover the development, and more importantly the
manufacturing, of biopharmaceutical products.
In conjunction with the launch of the Biacore(r)C, Biacore also introduced
a new system validation service, which is intended to further support our
customers' efforts to comply with generally accepted GLP/GMP standards.
In April 2003, and in order to ensure that Biacore's instrumentation will
meet the future needs of the regulatory authorities, Biacore launched a GLP/GMP
package for Biacore(r)3000 which will assist these customers in generating the
documentation and procedures that they need in their dealings with regulators.
In addition, Biacore has taken the decision to develop all relevant current and
planned systems to meet compliance guidelines so that it will be in a position
to capitalize on the expected growth of the validated instrument market as
regulatory bodies push compliance back down the discovery chain.
BUILDING A QUALITY CONTROL BUSINESS WITH THE FOOD INDUSTRY
Over the last several years, Biacore has been working to build up
recognition of its SPR technology's ability to provide novel solutions for food
analysis/QC (quality control).
In the last eighteen months, these modestly funded activities have started
to yield some significant results, particularly in terms of generating
accreditation/validation of the use of Biacore's SPR technology in a range of
food analysis applications.
In September 2002, Biacore achieved an important milestone in the
development of its food business. This milestone was the full validation and
certification as a Performance Tested Method of its folic acid analysis by the
AOAC (Association of Analytical Communities) Research Institute, the foremost
independent body determining food-testing standards worldwide.
The AOAC certification, which is recognized by food manufacturers globally,
means that Biacore is now in much stronger position to market its unique rapid
routine test for the determination of the vitamin food supplement folic acid.
In September 2002, Biacore also extended its product offering to the food
industry with the introduction of a highly sensitive test for the beta-agonist
ractopamine. This is an important test for the food industry due to
ractopamine's different regulatory status in the U.S. and Europe. In the U.S.,
ractopamine is licensed as a growth promoter for livestock while in Europe, its
use along with other beta-agonists is banned entirely. The test that Biacore has
developed for ractopamine is run on Biacore(r)Q and can be used for routine
testing.
These developments, allied to an expansion of its product offering, have
allowed Biacore to extend its customer base in the food industry to include some
of the world's major food manufacturers. The growing interest in applying
Biacore SPR technology in the food industry was reflected in the decision to
hold a special session on food applications at the Biacore Symposium that was
held in Chicago in May 2002, at which companies such as Nestle and Fronterra
from New Zealand made presentations.
SPR ARRAY TECHNOLOGY - HIGHER INFORMATION CONTENT FROM BIACORE'S NEXT GENERATION
SYSTEMS
In the late 1990s, Biacore's scientists made a number of technological
breakthroughs in SPR detection and micro-fluidics that have paved the way for
the development of a new SPR array system. Biacore expects this system to be
able to deliver a substantial improvement in the speed with which information on
protein interactions can be generated. It expects to introduce this system in
2004. Delivering the high sensitivity and data quality that Biacore's customers
currently receive, this new platform will enable Biacore's SPR technology to be
used in a wide range of applications in both basic life science research and
drug discovery and development.
The development of Biacore's SPR array technology is progressing in
accordance with Biacore's plans with Biacore having made significant investments
in order to drive the commercialization of this technology. In 2001, this
investment amounted to approximately SEK 30 million and a further approximately
SEK 35 million was invested in 2002. Biacore believes that this level of
investment has allowed recruitment of key personnel needed to develop and test
the individual modules that will make up the new SPR array systems.
BIACORE'S SPR ARRAY PARTNERS
To commercialize its SPR array technology, Biacore has on-going
communications and discussions with major pharmaceutical companies and other
people dealing with SPR and has entered into two collaborations to develop
specific applications and gain access to reagent expertize. These collaborations
and relationships enable Biacore to develop important elements in the
specification of the system to meet the demands of the end-users.
The first collaboration started in June 2000 with Millennium
Pharmaceuticals Inc. to examine potential applications of SPR array technology.
By collaborating with Millennium, Biacore expects to be able to develop new
systems that are tailored to the needs of major customers in the
pharmaceutical/biotechnology industry.
Input from Millennium's scientists on applications and industry needs has
enabled R&D efforts to focus on the key array technology formats that will meet
the requirements of Biacore's major target customer groups for higher throughput
SPR instrumentation. The agreed format will build on the advantages of Biacore's
proprietary SPR and micro-fluidics technology, emphasizing sensitivity, data
quality and high information content, combined with an increase in throughput
that Biacore believes will meet important industrial needs.
The SPR array system is designed for applications in the interaction
proteomics and post-HTS small molecule characterization areas, where its
sensitivity, increased throughput and high information content will complement
Biacore's existing systems. Over time, Biacore expects the SPR array system to
have applications across the spectrum of drug discovery and development
activities and be a valuable tool in many proteomics applications.
In order to address higher throughput proteomics applications, it is
important to have access to the right reagents. To achieve this, Biacore signed
a further complementary collaboration with the U.S. company BD Biosciences
Pharmingen in July 2002. This collaboration provides access to targeted panels
of antibodies and reagents for array applications. BD Biosciences Pharmingen
manufactures monoclonal antibodies, protein expression systems and recombinant
proteins using advanced bioprocessing techniques. It is part of BD Biosciences,
one of the world's largest businesses supporting the life sciences.
In addition, Biacore's SPR array technology has potential uses in the
clinical trials field where it is likely to be used to characterize the immune
response that is generated by drugs and their metabolites. To support such
future potential applications, the array system is being developed under a GAMP
model, to ensure that the system will meet global regulatory requirements when
launched.
COMPETITION
Biacore's market share in 2002 was approximately 90%, measured by its share
of references to SPR-based systems in scientific literature.
Currently, Biacore faces direct competition from approximately five other
manufacturers of instruments employing affinity-based biosensor technology.
In the food and beverage analysis market, Biacore faces competition from a
variety of other technologies. Immunoassays and culture methods have
traditionally dominated the food and beverage analysis market. Biacore also
competes in this market against the same classical techniques with which Biacore
currently competes in the life science research area, such as high-performance
liquid chromatography and mass spectrophotometry, which have increasingly been
adopted in the food analysis market.
Competition may also come from developing new technologies for measuring
biomolecular interactions. Biacore's business environment is characterized by
extensive research and technological change, and new developments are expected
to continue at a rapid pace. Biacore's future success will depend in large part
on its ability to maintain a strong position in technological development.
Major general device or instrument manufacturers may choose to enter the
affinity-based biosensor market. Moreover, Biacore believes that certain
entities have developed, are developing or are investigating the development of
technologies in areas that have direct application to affinity-based biosensor
systems.
GEOGRAPHICAL MARKETS AND MARKETING ORGANIZATION
The sales and marketing organization of Biacore focuses on providing highly
qualified support to enable customers to achieve their research and development
objectives.
Biacore has a direct presence with its own sales organizations in the
largest markets, North America, Europe and Japan, as well as sales branches in
Australia and New Zealand and distributors in many other countries. Sales is
reported divided into three sales regions; Americas, Europe and Asia-Pacific.
The following table presents sales broken down by region during the last
three financial years.
SEK For the years ended December 31
thousands 2002 2001 2000
Americas 270,524 249,347 191,872
Europe 173,894 151,004 139,152
Asia-Pacific 169,736 143,366 107,796
Total sales 614,154 543,717 438,820
In the Americas region, sales are handled by the Group's wholly-owned
subsidiary Biacore Inc. in New Jersey. Staff are based in a number of locations
across the United States. There are also distributors in major Latin American
countries. Approximately half of Biacore's sales in the Americas is to
industrial customers, primarily in North America's pharmaceutical and
biotechnology industries.
In the European region, sales in Germany, France, the United Kingdom,
Ireland, the Benelux countries, Switzerland, Austria and the Nordic countries
are made directly through branch offices. Biacore also has distributors in
other European countries, including Italy and Spain, and in the Middle East. The
majority of Biacore's customers in the European region have been in academia.
However, Europe has a strong presence within the pharmaceutical industry, which
is accounting for close to half of sales in Europe.
In the Asia-Pacific region, sales are made via the wholly-owned subsidiary
Biacore KK in Japan and through branch offices in Australia and New Zealand.
Other parts of the region are covered by a network of distributors. Sales in
Japan are generally made to specialized distributors who service specific
segments of the Japanese market. Such distributors act as intermediaries between
the importer/specialist and the users of the analytical systems. The main end
users in Asia-Pacific are universities and government research institutes, with
the pharmaceutical and biotechnology industry being another important customer
group.
Outside the main markets, Amersham Biosciences market and distribute
Biacore's products in a number of countries. During 2000 and 2001, Amersham
Biosciences was 45% owned by Biacore's largest shareholder Pfizer (Pharmacia)
(see also Note 2 of Notes to Financial Statements).
Under Biacore's distributor agreements, Biacore generally supplies the
distributor with centrally produced promotional material and assists in the
training of the distributor's sales and technical staff. The sales and marketing
of Biacore's products is otherwise conducted rather independently by the
distributor.
Biacore has three business units that develop the markets and co-ordinate
Biacore's efforts towards three key market segments:
- Pharmaceutical & Biotechnology.
- Basic Life Science Research.
- Food.
There are other central functions that continuously develop the
www.biacore.com website, which includes extensive customer service features,
publish the BIAJournal, develop technical literature, etc. Some of these central
marketing functions are highly integrated with the Technology Supply division,
which mainly includes the Research and Development organization.
New product launches, increased sales and an increase in direct
representation in Biacore's major markets, including the build-up of the
sales and marketing operation in Japan, has required a substantial build-up in
the resources dedicated to sales and other marketing activities. Total marketing
expenses increased from SEK 147.4 million in 2000 to SEK 199.8 million in 2002.
This increase reflects an increase in the number of employees engaged in
marketing activities from 95 at the end of 1999 to 143 at the end of 2002.
SEASONALITY
Historically, Biacore has had approximately 30 to 40% of annual sales in
the fourth quarter of each year. Combined with high fixed costs and significant
dependence on individual orders, the strong seasonality of sales has caused
operating income to vary substantially between different quarters.
PRODUCTS
The first Biacore(r) instrument using SPR was launched in 1990. Since then,
the technology has advanced considerably. These advances have broadened the
application of SPR technology.
There are now several Biacore(r) systems on the market, with the latest
products approximately 100 times more sensitive than the first and with
substantially increased throughput capacity. The systems generally consist of an
SPR instrument and a PC. Most of the instruments consist of a microfluidic
system, an optical detection unit and a sample handling unit. The PC controls
the system functions, except for manual operations such as inserting the sensor
chip into the instrument and pre-loading the samples. The measurements are
analyzed using Biacore's own evaluation software. Other examples of features of
the instruments include:
- On-line reference subtraction.
- Optimized wash routines which ensure that an efficient screening process
can be developed.
- Efficient recovery of material that has bound to the sensor surface during
an analysis which enables samples to be recovered and used for analysis by
mass spectrometry for sample identification purposes (the most common
technique used for the identification and characterization of a specific
target molecule).
- GxP functions for efficient compliance with regulatory requirements.
Biacore(r)S51 was launched in the third quarter of 2001. It is a
high-performace and high-throughput system designed to reduce bottlenecks in
drug discovery down-stream of high throughput screening (HTS).
Biacore(r)C was also launched in the second half of 2001. It has been
designed for concentration analysis with automatic report generation.
Biacore(r)C is the first system developed for use in a regulatory environment.
Biacore(r)3000 is Biacore's best-selling instrument and its top of the
line general purpose system. Biacore(r)3000 is a high sensitivity, fully
automated system for individual sample characterization and multi-sample
analysis, and is mainly used upstream of HTS.
The Procel(tm) system is based on new proprietary fluorescent cell-based
assay technology, is used for secondary screening and quantitative pharmacology
profiling of compounds using live cells, and had its full commercial launch in
March 2003.
Less expensive general purpose systems include Biacore(r)2000,
Biacore(r)1000, Biacore(r)X and Biacore(r)J. Biacore(r)Q is optimized for food
analysis. Other products include a number of different sensor chips, that have
been designed for characterization of specific types of interactions, and other
consumables such as reagents.
The prices of Biacore(r) instruments range from approximately
SEK 400 thousand to approximately SEK 5 million.
In general, Biacore warrants its new systems against defects in design,
materials and workmanship for one year. To date, the expense associated with
warranty claims has been immaterial.
Biacore also offers comprehensive after sales service contracts, which
include both routine maintenance and emergency servicing. Contracts are designed
to offer a flexible choice of service support, to suit both the system and the
customer's requirements.
To increase the size of the market and maximize utilization of its
expertize, Biacore has offered and performed Research Consulting Services (RCS)
since late 2001.
BIACORE'S SPR TECHNOLOGY
Biacore's SPR technology is able to add value, across a wide range of
industries and applications, through its ability to provide answers in real time
to important questions concerning the progress of biomolecular interactions.
Biacore's SPR technology can be used to measure:
Specificity - How specific is the binding between two molecules?
Kinetics - How fast does the binding take place?
Affinity - How strong is the binding?
Concentration - How much of a given molecule is present and active?
THE BASIS OF BIACORE'S SPR TECHNOLOGY
SPR is a phenomenon based on the transfer of light energy (photons) to a
group of electrons (a plasmon) on a metal surface. In Biacore's SPR technology,
the target molecule is bound to the surface of a gold-coated sensor chip. Once a
target molecule has been bound, solution from the test material is passed over
the sensor chip. The chip surface interacts with light at a characteristic angle
that depends on the molecular composition on the gold surface. Any binding to
the target molecule can be detected in real-time.
When molecules in the test solution bind to a target molecule at the sensor
chip surface, the angle of reflected light increases. When they detach, the
angle falls. These changes form the basis of the Biacore sensorgram, a
continuous, real-time monitoring of the attachment and detachment of interacting
molecules.
ADVANTAGES OF BIACORE'S SPR TECHNOLOGY
A fundamental advantage of Biacore's SPR technology is that unique
biomolecular binding data can be generated without the need for researchers to
label the molecules of interest. This reduces the time and workload needed to
carry out assays. It also helps eliminate the risks of misleading results caused
by the molecular changes that can result from sample labeling.
Another important benefit of Biacore's SPR technology is its ability to
monitor bio-molecular interactions continuously, thereby providing real-time
kinetic information. This is a major benefit for investigating molecular binding
events, which can often be quite transient, but yet significant. It is not
possible to generate detailed real-time data using traditional 'end-point'
analytical methods, which require large numbers of measurements at different
time intervals to picture bio-molecular binding processes.
Using Biacore's SPR technology, samples can often be analyzed without the
need for purification. This again improves the data quality and reduces time to
results. Because Biacore's technology does not make measurements through the use
of light absorption, samples that are light sensitive, turbid or colored can
also be analyzed.
These benefits have led to Biacore's SPR technology being used in a broad
range of areas.
PROCEL(tm) - COMPLEMENTING SPR WITH CELL-BASED COMPOUND PROFILING
In addition to progressing its SPR technology, in 2002 Biacore also
launched a new fluorescence-based instrument, Procel(tm), which is dedicated to
secondary screening and quantitative pharmacology profiling of compounds, using
live cells. The system complements Biacore's SPR technology in delivering the
high-content information needed to rapidly identify successful drug candidates.
Procel(tm) is the first automated system dedicated to high-content profiling of
compounds targeting G-protein coupled receptors and ion channels. Its
complementary position alongside Biacore(r)S51 allows important decisions to be
made earlier in the drug discovery process.
HIGH INFORMATION CONTENT SPR
Biacore continues to advance its SPR array technology. Developed partly in
collaboration with Millennium Pharmaceuticals Inc., this is designed to focus on
delivering the sensitivity, data quality and high information content, along
with increased throughput, demanded by customers. The SPR array platform will
build on Biacore's position in SPR and further develop its patented flow-based
micro-fluidics capabilities that are central to providing the sensitivity and
assay flexibility required for high-quality kinetic data and hence high
information content. The system will have the throughput and capabilities
required to simultaneously study targeted protein panels, providing a level of
information on protein interactions that has not previously been available. In
addition, the sensitivity and assay flexibility will enable small molecule
characterization against panels of related targets, saving time and resources in
drug discovery.
R&D INFRASTRUCTURE AND EXPENDITURES
Between 1993 and 1999, Biacore's R&D costs were rather constant and in the
range of SEK 41 million to SEK 53 million per year. In 2000 and 2001, R&D
expenses increased to SEK 73 million and SEK 105 million, respectively, largely
as a result of the programs to develop new high-performance systems and SPR
array technology. In 2002, R&D expenditures were almost unchanged at
SEK 104 million. The extent of R&D efforts increased in 2002, but there was
less engineering work undertaken or purchased relating to final design of new
products. Furthermore, in 2002, SEK 5 million of R&D was capitalized in
accordance with new Swedish accounting principles relating to product
development expenses (see Notes 1 and 5 of Notes to Financial Statements). In
general, variations from year to year have to a significant extent been due to
the volume of services purchased from external consultants for generic
engineering tasks.
The SPR array technology program cost approximately SEK 15 million in 2000,
SEK 30 million in 2001 and SEK 35 million in 2002.
R&D expenses as a percentage of sales decreased from 55% in 1993 to 16% in
1999, then increased to 17% and 19% in 2000 and 2001, respectively, and fell to
17% in 2002. Biacore's long-term target is to maintain R&D expenses at a level
corresponding to approximately 15% of sales.
INTELLECTUAL PROPERTY
Biacore actively seeks to protect its intellectual property by patenting
innovative developments, and has approximately 50 patents pending or granted
pertaining to most parts of its affinity biosensor technology, including:
- The optical sensor system.
- The sensor surface that enables selective molecular interactions.
- The surface plasmon resonance (SPR) based measurement unit.
- The optical component that is used to couple light from the measurement
unit to the sensor surface.
- The microfluidic system.
- SPR array technology.
Biacore has also been granted patents and filed applications for patents
pertaining to various analytical procedures, and has an exclusive license to use
certain patents and technical information regarding fiber-optic SPR detection.
In 2001, Biacore acquired an exclusive license to Axiom Biotechnologies'
proprietary fluorescent cell-based assay technology, with the exception of flow
cytometry-based applications.
"Biacore" is a registered trademark owned by Biacore, and Biacore is in
possession of the web address www.biacore.com, the Biacore homepage.
For a description of a legal proceeding brought by Biacore against Thermo
BioAnalysis Corp. for patent infringement, please see Item 5A "Operating
Results - Year Ended December 31, 2002 Compared with 2001 - Other Operating
Income."
See also Item 3D "Risk Factors - Patents and Proprietary Technologies" and
"Item 3D "Risk Factors - Collaborations."
MANUFACTURING AND SOURCES OF COMPONENTS, MATERIALS AND SUPPLIES
Biacore generally manufactures technically advanced and patented
components, including sensor chips, the optical measurement unit and key
components in the instruments' liquid handling systems. Final assembly of the
instruments and quality control are also conducted by Biacore. Through a network
of subcontractors for other components, materials and supplies, Biacore's fixed
production costs have been limited.
The current Biacore production facilities are sufficient for current
production volumes. However, to be able to cope with increases in production
volumes and new products, Biacore is extending its storage and logistics
facilities and may make further extensions in the medium term, see Item 4D
"Property, Plant and Equipment."
See also Item 3D "Risk Factors - Dependence on a Single Manufacturing
Facility" and "Dependence on Certain Sources of Supply."
QUALITY SYSTEMS
In February 2003, Biacore's main research and development and production
unit, Biacore AB, received certification according to the international quality
standard ISO 9001:2000 of its development and manufacturing of analytical
systems and consumables for use in the field of biotechnology. Quality assurance
and regulatory factors are becoming increasingly important to Biacore's
customers, and Biacore strongly emphasizes these issues.
C. ORGANIZATIONAL STRUCTURE
Biacore International AB is the parent company of the Biacore Group.
Biacore believes that it is not a subsidiary of any other entity, that it has
been considered to be an associated company to and therefore equity-accounted by
Pharmacia, and that it may be considered to be an associated company to Pfizer
and therefore equity-accounted by Pfizer. The following legal entities are
included in Biacore:
Company Incorporated in Ownership, %
Biacore International AB Sweden Parent
Biacore AB Sweden 100
Biacore Administration AB Sweden 100
Biacore International SA Switzerland 100
Biacore KK Japan 100
Biacore Holding Inc. United States 100
Biacore Inc. United States 100
XenoSense Ltd United Kingdom 84 (1)
(1) Biacore has no formal ownership in XenoSense Ltd but would receive
approximately 84% ownership upon conversion of convertible loans made by
Biacore to XenoSense.
Business is carried out under the legal name of each respective legal
entity.
D. PROPERTY, PLANT AND EQUIPMENT
Biacore owns one property. It is located in Uppsala, Sweden and has an area
of 35,347 square meters of freehold land. At December 31, 2002, the property
included one main building for industrial and office use, two office buildings
and two mobile office units. All five are attached and have a total usable area
("bruksarea") of approximately 9,500 square meters. The vast majority of
Biacore's production and research and development activities are carried out on
this property. It also houses the Swedish marketing and administrative
functions.
During 2002, the group headquarters was moved to the Swiss subsidiary
Biacore International SA, which rents a combined office and light industrial
area of approximately 1,500 square meters on a five-year lease in Neuchatel,
Switzerland. The facility also includes a small office and light industrial
building owned by Biacore but located on land included in that lease agreement.
Biacore believes that the space owned and leased by it at December 31,
2002, while adequate for its activities during 2002, was too small for Biacore's
anticipated near- or medium-term activities. However, during the second quarter
of 2003, Biacore is completing an extention of its storage and logistics
facility in Uppsala by approximately 1,200 square meters. There is also a slight
shortage of office and other space for the marketing, administration and
research and development functions, and in the medium-term the production
facilities may need to be expanded. E.g., Biacore may make further extensions of
its building complex in Uppsala in the near or medium term.
The amount of future expenditure for ongoing and other decided property
projects is not expected to be material to Biacore and is expected to be
financed from existing liquid funds.
Biacore leases a small number of other properties of limited size for use
in its operations, and believes that the terms of its leases generally reflect
market rates in their respective areas.
See also Item 4A "History and Development of the Company - Principle
Capital Expenditures and Divestitures."
ITEM 5. OPERATING AND FINANCIAL REVIEW AND PROSPECTS
A. OPERATING RESULTS
GENERAL
The following discussion should be read together with and is qualified in
its entirety by reference to Item 3A "Selected Financial Data" and the financial
statements of Biacore included in Item 17 herein. The financial data analyzed in
this discussion has been prepared in accordance with Swedish GAAP, which differs
in certain significant respects from U.S. GAAP. See Note 23 of Notes to
Financial Statements for a description of significant differences between
Swedish GAAP and U.S. GAAP applicable to Biacore.
OVERVIEW
There is potential for further significant advances in the life sciences
and, as a result, for high demand for new and improved research tools. Products
developed, manufactured and sold by Biacore have often been useful and sometimes
essential in such life science research and development work. The rapid advances
in genomics have increased the potential for research and development within
proteomics and other areas. One of the most promising areas for increased demand
for Biacore's technology is drug discovery applications mainly within the
pharmaceutical and biotechnology industries. Biacore believes that its present
and future SPR-based analytical systems can play an important role in this
development.
Biacore has developed the technology of SPR-based analytical systems, and
the market for these systems has grown in response to Biacore's efforts in
fostering awareness of the technology's capabilities and potential. Management
expects that, in the medium and long term, the overall market for SPR-based
systems will continue to expand through Biacore's efforts as well as through the
activities of competitors that have already or may enter the market.
Over time, increased competition is expected to reduce Biacore's share of
the market, which since a number of years has been approximately 90%, measured
by its share of references to SPR-based systems in scientific literature.
Increased competition is expected to increase pressure on product margins over
time.
However, one of the key elements of Biacore's strategy is to invest in
research and development in order to maintain the technological position of
its products, which to date has allowed Biacore to maintain satisfying gross
margins.
Biacore has substantially increased its endeavours to develop technology
for the application of SPR technology in the drug discovery sector.
SPR array technology remains one of the primary research and development
projects. The technology is based on further development of the principles of
detection, immobilization and sample and reagent handling, and will make it
possible to use a large number of measurement spots simultaneously. In July
2002, Biacore and BD Biosciences Pharmingen, one of the world's largest
manufacturers of reagents, announced a research collaboration for the
development of methods for quality control of antibodies and reagents, and
development of applications of the SPR array technology. Extensively
characterized antibodies and reagents are considered to be important to the
development of the protein array market. This collaboration is complementary to
Biacore's collaboration with Millennium Pharmaceuticals Inc. Biacore retains the
right to commercialize technology-related developments arising from these
collaborations. The SPR array project is currently on target. If the project can
be completed as planned, the first instrument is expected to be launched in the
year 2004.
In November 2002, Biacore introduced Procel(tm), an analytical system that
is based on proprietary fluorescent cell-based assay technology acquired in 2001
for USD 5 million (SEK 53.6 million). Procel(tm) is designed specifically for
cell-based secondary screening and pharmacology profiling of potential new drug
leads, and will complement Biacore's existing molecular-based systems. Sales
activities started in 2003.
In October 2001, Biacore and Bruker Daltonics entered into an agreement
that aims to commercialize the combination of Biacore's SPR technology and
Bruker Daltonics' mass spectrometry technology. The co-operation has produced
results in the form of model analytical systems that combine SPR and mass
spectrometry technology in a comprehensive platform for functional proteomics
studies.
Biacore's results of operations are also dependent on Biacore's ability to
further penetrate the market within basic life science research, where major
life science research laboratories make up the main customer group. In this
market, which accounted for approximately 55% of its sales in 2002, Biacore has
mainly sold to well-known life science laboratories, with proteomics, cancer
research and neuroscience being important areas of application.
Other applications that present significant opportunities for Biacore
include quality control, process control and environmental analysis; with target
customer groups in the food and beverage, pharmaceutical, biotechnology and
chemical industries and government laboratories. Biacore's sales will also be
affected by Biacore's ability to make further technological advances, expand its
product range, introduce new applications and expand the customer base.
In light of the further potential that Biacore believes its technology to
possess, Biacore has continued to increase the resources devoted to marketing
activities. Total marketing expenses increased from SEK 147.4 million in 2000 to
SEK 199.8 million in 2002. This increase reflects an increase in the number of
employees engaged in marketing activities from 95 at the end of 1999 to 143 at
the end of 2002, including the build-up of the Biacore marketing operation in
Japan.
Biacore's revenues are generated primarily from sales of analytical
systems. Revenues are also generated by sales of consumables, after sales
services, spare parts, rental of analytical systems and research consulting
services.
Biacore's sales have typically shown a pattern of being unevenly
distributed over the year, with the strongest sales during the fourth quarter of
each year, principally due to its customers' typical budgeting and capital
expenditure patterns. This pattern, together with the high proportion of fixed
costs in Biacore, has caused operating income to be even more disproportionately
distributed over the year. This pattern will probably continue, but the future
extent of these variations is uncertain.
During the year 2002, the legal and commercial structure of Biacore
changed. The head office was moved to the subsidiary Biacore International SA,
located in Neuchatel, Switzerland. Biacore International SA also acts as the
commercial center of Biacore, and includes the Pharmaceutical and biotechnology
business unit and certain production and logistics activities. Neuchatel is
located in a regional development zone and the taxation of Biacore International
SA is subject to certain conditions tied to the development of its operation in
Neuchatel. Biacore believes that the new structure of the Group will have a
favorable impact on its average tax rate. Uppsala remains the domicile of the
Company and the Group's center for research and development and production.
Other factors which affect sales and income include the timing of new
product introductions by Biacore and other manufacturers of competing analytical
systems, regulatory actions, government funding of research, the growth rate of
the pharmaceutical and biotechnology industry and general economic trends.
Biacore's business is also characterized by a number of other factors which
make future sales and income difficult to predict. See Item 3D "Risk Factors."
Biacore's sales fell by 25% in the first quarter of 2003 to
SEK 106.5 million compared with SEK 141.3 million in the first quarter of 2002.
Diluted earnings per share fell by 65% from SEK 2.17 in the first quarter of
2002 to SEK 0.77 in the first quarter of 2003.
YEAR ENDED DECEMBER 31, 2002 COMPARED WITH 2001
The following table sets forth certain consolidated income statement data
for Biacore expressed as a percentage of sales for the periods indicated:
% For the years ended December 31
2002 2001 2000
Sales 100.0 100.0 100.0
Cost of goods sold -16.4 -18.4 -17.8
Marketing -32.5 -34.7 -33.6
Administration -11.1 -16.0 -13.9
Research and development -17.0 -19.3 -16.6
Operating foreign
currency gains and losses -2.7 0.9 0.8
Other income 3.4 0.2 -
Other expenses -0.1 - -
Amortization of goodwill -0.7 -0.9 -1.1
Operating income 22.9 11.8 17.8
The table below sets forth Biacore's sales by geographic area for the
periods indicated:
SEK thousands For the years ended December 31
2002 2001 2000
Americas 270,524 44.0% 249,347 45.9% 191,872 43.7%
Europe 173,894 28.3% 151,004 27.8% 139,152 31.7%
Asia-Pacific 169,736 27.7% 143,366 26.3% 107,796 24.6%
Total sales 614,154 100.0% 543,717 100.0% 438,820 100.0%
Sales
Sales increased by 13.0% from SEK 543.7 million in 2001 to
SEK 614.2 million in 2002. Excluding currency effects, sales increased by 14.0%
(measured by applying currency exchange rates for 2001 to the 2002 revenues in
local currencies).
As in 1999, 2000 and 2001, Biacore(r)3000, launched in 1998, was Biacore's
best-selling analytical system.
In the Americas, sales increased by 8.5% from SEK 249.3 million in 2001 to
SEK 270.5 million in 2002. Again, the Americas was Biacore's best-selling
region, even though sales in the second half-year and to the pharmaceuticals
industry was lower than expected.
Sales in Europe increased by 15.2% from SEK 151.0 million in 2001 to
SEK 173.9 million in 2002. Market conditions in Europe remained stable and
increased efforts were focused on introducing Biacore's analytical systems in
drug discovery applications. During the fourth quarter of 2002, Biacore
completed an extensive restructuring of the sales and support organization in
Europe.
In Asia-Pacific, sales increased by 18.4% from SEK 143.4 million in 2001 to
SEK 169.8 million in 2002, making Asia-Pacific the fastest-growing region within
Biacore. The increase was equally strong in both Japan, the largest market
within the Asia-Pacific region, and other countries.
The increase in total sales was an effect of higher volumes and a change
in product mix. The increase also reflected a 17% increase, from
SEK 111.3 million in 2001 to SEK 129.9 million in 2002, in sales of consumables,
after sales services and spare parts, each of which depends primarily on the
installed base of Biacore instruments.
Cost of Goods Sold
Cost of goods sold remained relatively stable at SEK 100.9 million in 2002
compared with SEK 99.8 million in 2001. As a percentage of sales, these costs
decreased from 18.4% in 2001 to 16.4% in 2002 after having increased in the
prior year.
Marketing
Marketing expenses increased by 6% from SEK 188.7 million in 2001 to
SEK 199.8 million in 2002, corresponding to 34.7% of sales in 2001 and 32.5% in
2002. Thus, marketing expenses increased at a lower rate than sales.
Administration
Administrative expenses decreased by 21% from SEK 86.7 million in 2001
(16.0% of sales) to SEK 68.3 million in 2002 (11.1% of sales), after having
increased by 43% in 2001. During 2001, administrative expenses included a charge
of SEK 13 million relating to pension to the former Chief Executive Officer.
Research and Development
After having increased by 38% in 2000 and 44% in 2001, research and
development expenses decreased marginally from SEK 104.7 million in 2001 to
SEK 104.4 million in 2002. In 2001, research and development expenses included
significant expenses relating to the development of the Biacore(r)S51 and
Biacore(r)C systems. As from 2002, product development expenses that fulfil
certain criteria are capitalized and amortized over their estimated economic
lives (See Notes 1 and 5 to the financial statements). Capitalization of product
development has reduced research and development expenses by SEK 5.0 million in
2002. As a proportion of sales, research and development expenses decreased from
19.3% to 17.0%.
Operating Foreign Currency Gains and Losses
Net operating foreign currency gains and losses, which mainly relate to
accounts receivable, decreased from SEK 4.5 million in 2001 to SEK -16.6 million
in 2002. The amount mainly relates to the appreciation of the Swedish krona
against the U.S. dollar and Japanese yen in 2002.
Other Operating Income
In 2002, the United States Court of Appeals for the Federal Circuit
confirmed an earlier judgement relating to infringement by Thermo BioAnalysis
Corp. on Biacore's U.S. patent No. 5,436,161. The SEK 19.6 million in damages
awarded is included in Other income during 2002, which increased from
SEK 0.7 million in 2001 to SEK 21.0 million in 2002.
Amortization of Goodwill
All goodwill relates to the acquisition by Biacore's Japanese subsidiary of
Amersham Biosciences' Japanese sales operation for Biacore products. See also
Note 5 of Notes to Financial Statements. For a description of the treatment of
the contract with Amersham Biosciences according to United States generally
accepted accounting principles, see Note 23 of Notes to Financial Statements.
Operating Income
For the reasons discussed above, Biacore's operating income increased by
119% from SEK 64.1 million in 2001 to SEK 140.6 million in 2002, representing an
increase in operating margin from 11.8% in 2001 to 22.9% in 2002.
Financial Items, net
Financial items, net, decreased from income of SEK 13.8 million in 2001 to
a loss of SEK 20.4 million in 2002. Interest income increased slightly from
SEK 10.0 million in 2001 to SEK 10.2 million in 2002. Interest expenses
increased from SEK 1.1 million in 2001 to SEK 1.8 million in 2002 due to a
higher calculated interest on the pension liability administered by the Swedish
Pension Registration Institute PRI. Net financial foreign currency gains and
losses decreased from SEK 0.2 million in 2001 to SEK 0.0 million in 2002.
Biacore's financial foreign currency gains and losses derive from temporary
lending to, and temporary borrowing of surplus liquidity from, non-Swedish
subsidiaries. As a result of a deteriorating business climate and financing
situation for early-stage biotechnology companies, Biacore has made write-downs
against its portfolio related to this sector. This has caused a charge to the
financial net of SEK -28.7 million.
Income Taxes
Income taxes increased from SEK 27.6 million in 2001 to SEK 40.1 million in
2002. Biacore's effective tax rate decreased from 35% in 2001 to 33% in 2002.
This still relatively high level of taxation resulted from losses on equity
instruments only being deductible against gains on similar financial instruments
according to legislation and regulations in effect on December 31, 2002. At
December 31, 2002, Biacore had no realized or unrealized gain on any such
instrument against which it could offset any loss. This effect was partly offset
by a change in the geographical mix of income in subsidiaries, one factor being
the establishment of the group headquarters and commercial center in Neuchatel,
which is located in a regional development zone in Switzerland.
Net Income
Net income increased by 60.7% from SEK 50.3 million in 2001 to
SEK 80.8 million in 2002, corresponding to an increase in basic earnings per
share from SEK 5.16 in 2001 to SEK 8.28 in 2002 and an increase in diluted
earnings per share from SEK 5.04 in 2001 to SEK 8.20 in 2002.
YEAR ENDED DECEMBER 31, 2001 COMPARED WITH 2000
Sales
Sales increased by 23.9% from SEK 438.8 million in 2000 to
SEK 543.7 million in 2001. Excluding currency effects, sales increased by 15.6%
(measured by applying currency exchange rates for 2000 to the 2001 revenues in
local currencies). The favorable currency effect mainly resulted from
appreciation of the average value of the United States dollar and to a lesser
extent the British pound and the euro.
In the Americas, sales increased by 30.0% from SEK 191.9 million in 2000 to
SEK 249.3 million in 2001. The importance of this region to Biacore again
increased as it accounted for 46% of sales in 2001. Both the Pharmaceutical and
Biotechnology and Life Science business units performed well.
Sales in Europe increased by 8.5% from SEK 139.1 million in 2000 to
SEK 151.0 million in 2001.
In Asia-Pacific, sales increased 33.0% from SEK 107.8 million in 2000 to
SEK 143.4 million in 2001. Sales to the Japanese pharmaceuticals industry
increased significantly and outside Japan sales almost doubled.
The increase in total sales was an effect of higher volumes and currency
effects. The increase also reflected a 24% increase, to SEK 111.3 million, in
sales of consumables, after sales services and spare parts.
Cost of Goods Sold
Cost of goods sold increased from SEK 78.1 million in 2000 to
SEK 99.8 million in 2001. As a percentage of sales, these costs increased from
17.8% in 2000 to 18.4% in 2001. The gross margin was thereby approximately
unchanged at 82%.
Marketing
Marketing expenses increased from SEK 147.4 million in 2000 to
SEK 188.7 million in 2001, corresponding to 33.6% of sales in 2000 and 34.7% in
2001. An increase in the number of sales and other marketing personnel in mainly
the United States led to a 28% increase in marketing expenses, which is somewhat
higher than the increase in sales.
Administration
Administrative expenses increased from SEK 60.8 million in 2000 (13.9% of
sales) to SEK 86.7 million in 2001 (16.0% of sales), an increase of 43%.
Approximately half of the increase was due to an expense of SEK 13 million for
pension to the former Chief Executive Officer.
Research and Development
Research and development expenses increased by 44% from SEK 72.8 million
in 2000 to SEK 104.7 million in 2001, mainly due to the SPR array and high
performance system projects. As a proportion of sales, research and development
expenses increased from 16.6% in 2000 to 19.3% in 2001.
Operating Foreign Currency Gains and Losses
Net operating foreign currency gains, which mainly relate to accounts
receivable, increased from SEK 3.2 million in 2000 to SEK 4.5 million in 2001.
Amortization of Goodwill
All goodwill relates to the acquisition by Biacore's Japanese subsidiary of
Amersham Biosciences' Japanese sales operation for Biacore products.
Operating Income
For the reasons discussed above, Biacore's operating income decreased from
SEK 78.0 million in 2000 to SEK 64.1 million in 2001, representing a decrease in
operating margin from 17.8% in 2000 to 11.8% for 2001.
Financial Items, net
Financial items, net, increased from income of SEK 8.7 million in 2000 to
income of SEK 13.8 million in 2001. Net interest income increased from
SEK 7.4 million in 2000 to SEK 8.9 million in 2001 due to a higher average net
interest-bearing asset and better interest rates received. Net financial foreign
currency gains and losses decreased from SEK 1.3 million in 2000 to
SEK 0.2 million in 2001. Furthermore, in 2001, 1,000,000 shares in Axiom were
sold at a gain of SEK 4.6 million.
Income Taxes
Income taxes were unchanged at SEK 27.6 million in 2001. Biacore's
effective tax rate increased from 32% in 2000 to 35% in 2001. The increase was
due to a sharp reduction of the loss in the Japanese subsidiary, where the
applicable tax rate is approximately 42% and for which a part of the tax loss
carry forward has been accounted for as a deferred tax asset, and higher
non-deductible pension expenses as a result of the shortening of the accrual
period for pension to the former Chief Executive Officer Lars-Goran Andren.
Net Income
Net income decreased by 15.0% from SEK 59.1 million in 2000 to
SEK 50.3 million in 2001. Basic earnings per share fell from SEK 6.06 in 2000 to
SEK 5.16 in 2001, and diluted earnings per share fell from from SEK 6.02 in 2000
to SEK 5.04 in 2001.
INFLATION
During the three year period ended December 31, 2002, inflation in Sweden
amounted to approximately 2% per year. At the level indicated, inflation had
limited impact on the Company's operations or financial condition.
FOREIGN CURRENCY FLUCTUATIONS
For a description of the effects of foreign currency fluctuations and
hedging activities, see this Item 5A "Operating Results" above, Item 11
"Quantitative and Qualitative Disclosures About Market Risk" and Note 19 of
Notes to Financial Statements.
GOVERNMENTAL POLICIES AND FACTORS
Biacore is affected by a large number of government policies and factors.
Apart from large government funding of customers' purchases of products and
services from Biacore (see Item 3D "Risk Factors - Funding of Customers"),
Biacore believes that it is not subject to any other government policy or factor
of which a description is required in this context.
BUSINESS CYCLES AND GENERAL ECONOMY
Biacore believes that it may be less affected by business cycles and the
general economy than many other companies, that are often more dependent on
limited geographical markets. However, capital goods, which make up the vast
majority of Biacore's sales, are highly sensitive to the growth, financial
position and competing other short or long-term priorities of their customers
and customers' funding organizations.
OFF-BALANCE SHEET ARRANGEMENTS
At December 31, 2002, Biacore had contractual obligations involving
SEK 37.9 million in operating lease payments and contingent liabilities of
SEK 0.5 million (see Note 16 of Notes to Financial Statements).
See also Item 11 "Quantitative and Qualitative Disclosures about Market
Risk" and Note 23 of Notes to Financial Statements - Hedge on Social Security
Costs of Stock Options.
These off-balance sheet arrangements could have been financed by Biacore's
liquid funds and are of limited importance to Biacore.
IMPORTANT ACCOUNTING POLICIES AND NEW ACCOUNTING STANDARDS
The preparation of financial statements 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 dates of
the financial statements and the reported amounts of revenues and expenses
during the reporting periods. Actual results could differ from those estimates.
See Note 1 of Notes to Financial Statements for a presentation of the most
important of the Company's accounting policies.
Those accounting policies and issues that Biacore believes involve the
largest uncertainties in, and therefore also risks to, the presentation of the
position and performance of the Company relate to research and development,
impairment of intangible assets, incentive stock options and deferred tax
assets.
The allocation of research and development expenses between product
development expenses to be capitalized and amortized, and product development
expenses to be charged to income, involves highly judgmental issues such as
estimated future sales and the certainty of such estimates. The same applies to
already capitalized product development.
If there is indication of an impairment of an intangible asset or a
property, plant or equipment, then the recoverable cost of the asset is
calculated. If the recoverable cost is less than the carrying amount of the
asset, a write-down to the recoverable amount is recorded. Biacore has goodwill
relating to its Japanese sales operation and capitalized acquisition cost
related to fluorescent cell-based assay technology. The estimated fair values of
these assets have been regularly calculated by applying the discounted cash flow
method to the forecasted future performance of these businesses. The last such
calculations have indicated that the assets are not impaired. However, the
analyses rely on forecasts of future sales and expenses which involve
considerable uncertainty. At this early stage, Biacore has had no significant
revenue from any product based on fluorescent cell-based assay technology.
In Biacore's opinion, Swedish companies are currently not required to
charge incentive stock options to income. Accordingly, Biacore has not charged
incentive stock options to income. However, in the future, Biacore may charge
incentive stock options to income as remuneration.
The Japanese entity Biacore KK has made significant losses. At December 31,
2002, the accumulated tax loss carryforward was approximately SEK 40.0 million
and it expires over the five-year period between 2003 and 2007. Based on a
forecast of the future performance of Biacore KK, Biacore has calculated a
deferred tax asset as required by generally accepted accounting principles and
made a valuation allowance for the portion that is not expected to be utilized
(see Note 4 of Notes to Financial Statements). The calculation of the valuation
allowance relies on forecasts of future sales and expenses which involve
considerable uncertainty.
Several new accounting standards based on International Financial Reporting
Standards from the International Accounting Standards Board have recently been
adopted by the Swedish Financial Accounting Standards Council. Those new
standards are not expected to have any material effect on Biacore's reported
financial position or results of operations during 2003. The Swedish Financial
Accounting Standards Council's statement No. 29 Employee Benefits is effective
for financial years beginning January 1, 2004 or later. Biacore does not expect
the impact of the adoption of this accounting standard to be material to its
income statement or balance sheet, but will further assess its impact at a later
date. See also Note 1 of Notes to Financial Statements.
See Note 23 of Notes to Financial Statements regarding generally accepted
accounting principles in the United States, including recently announced changes
to United States accounting and disclosure requirements.
B. LIQUIDITY AND CAPITAL RESOURCES
Biacore's balance of liquid funds was SEK 220.8 million at December 31,
2001 and SEK 351.6 million at December 31, 2002. Of liquid funds,
SEK 90.9 million at December 31, 2001 and SEK 182.8 million at December 31, 2002
consisted of cash and cash equivalents as defined under U.S. GAAP. See Note 23
of Notes to Financial Statements for a further discussion of cash and cash
equivalents according to U.S. GAAP.
For a description of Biacore's liquid funds and related treasury policies,
see Notes 12, 18 and 19 of Notes to Financial Statements.
At December 31, 2002, Biacore had only SEK 4.3 million in financial debt, and
no other interest-bearing debt or borrowing commitments from external sources.
There is currently no significant seasonality in borrowing requirements. The
current financial debt is related to regional development support received in
Switzerland.
Net cash provided by operating activities has been between SEK 18 million
and SEK 164 million over the past three years, with variations mainly being due
to the timing of sales and payments of sales and expenses around year-ends, and
changes in income before write-downs.
Transactions and balances with Pfizer (Pharmacia) are specified in Note 2
of Notes to Financial Statements.
Net cash used in investing activities were SEK 64.3 million in 2000,
SEK 65.3 million in 2001 and SEK 37.1 million in 2002. Investments in intangible
assets amounted to SEK 0 million, SEK 57.5 million and SEK 7.0 million in 2000,
2001 and 2002, respectively. Of the amount in 2001, USD 5 million (SEK 53.6
million) related to the acquisition of a license from Axiom Biotechnologies Inc.
("Axiom") and the amount in 2002 mainly related to capitalized research and
development (see Notes 1 and 5 of Notes to Financial Statements).
There was no investment in property in 2000. In 2001, SEK 8.6 million was
invested in further offices in Uppsala. In 2002, SEK 16.7 million was invested
in buildings, mainly a storage and logistics unit in Uppsala. Purchases of
machinery and equipment were SEK 14.2 million in 2000, SEK 31.4 million in 2001
and SEK 15.1 million in 2002. The increase in purchases of machinery and
equipment in 2001 was due to Biacore's expansion and capital expenditure on
buildings. In 2000, investments also included SEK 0.8 million in payments for
the acquisition of the Japanese sales operation. In 2000, Biacore invested
SEK 50.8 million in a number of technology ventures related to Biacore's
business. These investments included SEK 36.7 million in shares in Axiom, a
further SEK 10.2 million in shares in Bioreason Inc. and SEK 3.9 million in a
convertible loan to XenoSense Ltd. In 2001, there was no purchase of long-term
investments. USD 3 million was received in 2001 for the sale of 1,000,000 shares
in Axiom to Axiom. The two transactions with Axiom in 2001 referred to in this
subsection were negotiated simultaneously and the payments of USD 5 million to
Axiom and USD 3 million from Axiom were netted. The acquisition and
consolidation of XenoSense is described in Note 21 of Notes to Financial
Statements, and led to SEK 1.6 million in higher liquid funds in the Biacore
Group balance sheet in 2002. Due to the classification of marketable securities
with more than 3 months until maturity at the day of acquisition as investing
activities under U.S. GAAP, net cash used in investing activities was
SEK 70.9 million lower in 2000, SEK 1.6 million higher in 2001 and
SEK 33.9 million higher in 2002 under U.S. GAAP as compared with Swedish GAAP.
See also Note 23 of Notes to Financial Statements.
Net cash provided by (used in) financing activities was SEK -7.9 million in
2000, SEK 0.0 million in 2001 and SEK 4.2 million in 2002. The items relate to a
temporary interest-bearing loan in a subsidiary and regional development
support.
Biacore has a tax loss carry-forward in Japan amounting to approximately
SEK 40.0 million (see Note 4 of Notes to Financial Statements).
There have not been, are not currently and are not within the foreseeable
future expected to be any or only limited restrictions on the ability of
subsidiaries to transfer funds to the parent company in the form of cash
dividends, loans or advances.
Biacore's use of financial instruments for hedging purposes is described in
Item 11 "Quantitative and Qualitative Disclosures About Market Risk."
At December 31, 2002, there was no material commitment for capital
expenditure.
The working capital of Biacore is sufficient for its present requirements.
However, Biacore may make further significant investments, e.g. in connection
with potential acquisitions in new market areas, the development and acquisition
of complementary technology and intellectual property, expansion of facilities
in Uppsala or elsewhere, and the development of its sales infrastructure both
organically and through the acquisition of direct control over distribution in
certain geographic markets. To the extent that its existing financial resources
are deemed to be insufficient to meet Biacore's capital needs, Biacore intends
to seek additional debt and/or equity financing to capitalize on these
opportunities.
C. RESEARCH AND DEVELOPMENT, PATENTS AND LICENSES, ETC
Although Biacore has a number of research and development collaborations
with other entities, virtually all research and development expenses relate to
company-sponsored activities. Total research and development expenses for each
of the years in the three-year period ending December 31, 2002 are stated in the
Income Statement in the Financial Statements. In addition, SEK 5.0 million of
research and development was recorded as capitalized product development in the
balance sheet in 2002. For a description of Biacore's research and development
activities, see Item 4B "Business Overview", Item 5A "Operating Results" and
Notes 1 and 5 of Notes to Financial Statements. See also Item 3D "Risk Factors."
D. TREND INFORMATION
See Item 5A "Operating Results", Item 5B "Liquidity and Capital Resources"
and Note 22 of Notes to Financial Statements.
ITEM 6. DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES
A. DIRECTORS AND SENIOR MANAGEMENT
DIRECTORS
Biacore currently has the following directors:
Lars-Goran Andren. Born 1943, Non-Executive Chairman of the Board since
January 2002. Executive Chairman and Chief Executive Officer between 2000 and
2001. Director, President and CEO between 1992 and 2000. Formerly Group Vice
President, Corporate Development, at Kabi Pharmacia AB. Director of Medivir AB.
M.Sc. Chem. Eng., Chalmers University of Technology, Gothenburg, Sweden.
Donald R. Parfet. Born 1952. Deputy Chairman of the Board since 2000.
Chairman of the Board between 1996 and 2000. Executive President Apjohn Group
LLC. Director of Bronson Health Care Group, Kalamazoo College, MPI Research
Inc., SenseGene Therapeutics Inc. and W.E. Upjohn Institute. Former Senior Vice
President, Associated Businesses of Pharmacia. MBA, University of Michigan,
United States.
Gordon Edge. Born 1937. Director since 1993, Chairman and founder of the
Generics Group AG, a U.K. listed technology consulting, business development and
investment firm. Trustee, Treasurer and Council Member of the Royal Society of
Arts and Sciences. Chairman of Cambridge University-MIT Advisory Board.
Associate Professor at the University of Bath, United Kingdom. Advisory Board
member of EPFL, Lausanne, and the Entrepreneurship Center, University of
Pennsylvania. Director of Applied NanoSystems BV, ETeCH AG and Quantum Beam Ltd.
D.Tech., MIEE., C.Eng., CBE, Member of IVA.
Tom Erixon. Born 1960. Director since 1999. Group Vice President of
Corporate Business Development and IT at Sandvik AB. Director of Seco Tools AB.
Between 1988 and 2001 active within the Boston Consulting Group and Managing
Partner in Denmark between 1998 and 2001. Master of Laws, Lund University,
Sweden and MBA from IESE, Barcelona, Spain.
Ulf Jonsson. Born 1953. Chief Executive Officer since January 2002.
Director and President since 2000. Executive Vice President and Chief Scientific
Officer between 1998 and 2000. Former Head of Project Management and Marketing
Director at Pharmacia Biotech. Ph.D. in Applied Physics and M.Sc. in Physics and
Electronics at Linkoping University, Sweden.
Magnus Lundberg. Born 1956. Director since 2002. Executive President of
Pharmacia Diagnostics. Chairman of the Board of Allergon AB. Director of
Aerocrine AB, Onyx Inc., Sweden Biotechnology Industry Organization and
Uppsvenska Handelskammaren. Former Vice President of Chiron Corp. Active within
the Pharmacia group between 1981 and 1996. M.Sc. in biochemistry and biology,
Abo Akademi, Finland.
Mats Pettersson. Born 1945. Director since 2000. Chief Executive Officer of
Biovitrum from 2001. Director of Lundbeck A/S and Sweden Biotechnology Industry
Organization. Former Senior Vice President, Mergers & Acquisitions of Pharmacia
Corporation. Active within the Pharmacia Group between 1976 and 2001. MBA,
Gothenburg School of Economics, Sweden.
Marc Van Regenmortel. Born 1934. Director since 1995. Chairman of the
International Committee on Taxonomy of Viruses. Director of Entomed Ltd.,
Kalmar Biotechnology and Pepscan Ltd. Emeritus director at the Biotechnology
School of the University of Strasbourg, France. Former Secretary General of the
International Union of Microbiological Societies. Ph.D., University of Cape
Town, South Africa.
Anna Hansson. Born 1964. Director (employee representative) since 2000.
B.Sc. in Organic Chemistry, Uppsala University, Sweden. Employed since 1987.
Markku Hamalainen. Born 1958. Director (employee representative) since
2000. Ph.D. in Chemometrics, Agricultural University of Sweden. Employed since
1993.
Eva-Lotta Hedstrom. Born 1960. Deputy Director (employee representative)
from May 2002.
Hans Sjobom. Born 1968. Deputy Director (employee representative) since
2000.
George Van der Veer. Born 1948. Deputy Director (employee representative)
to May 2002.
SENIOR MANAGEMENT
The Executive Management Group of Biacore currently consists of:
Ulf Jonsson, Born 1953. Chief Executive Officer since 2002 and President
since 2000. See also Item 6A "Directors and Senior Management - Directors."
Lars-Olov Forslund, born 1952. Executive Vice President and Chief Financial
Officer since 1997. Former CFO at the Nordic steel group Fundia AB. MBA, Uppsala
University, Sweden.
Anders Svenberg. Born 1956. Executive Vice President and Head of Human
Resources since 2000. Former Vice President of Human Resources at Pharmacia &
Upjohn, Sweden. Master of Laws, Stockholm University, Sweden.
B. COMPENSATION
Non-executive board members do not receive stock options or other
compensation, except for the board fee and normal remuneration to employee
representatives. Senior management participate in stock option plans subject to
limitations decided by shareholders' meetings and applied by the board of
directors of Biacore.
Non-executive board members, except for employee representatives, do not
participate in any bonus plan. Senior management do participate in bonus plans.
Bonuses are calculated as a proportion of base salaries and depend on group
business performance and achievement of individual objectives.
See also Note 20 of Notes to Financial Statements, where information on
compensation reflects compensation accrued.
C. BOARD PRACTICES
Directors are elected for a period until the next Annual General Meeting of
shareholders. Any Extra General Meeting of shareholders may, effective
immediately, end the term of or elect new directors. Apart from notice periods
and severance payments disclosed in Note 20 of Notes to Financial Statements,
there are no terms of office for senior management. The period during which
Directors and senior managers have served is disclosed in Item 6A "Directors and
Senior Management."
Employee representatives have normal termination and pension benefits.
Among other directors, only two, the former Executive Chairman of the Board, and
the current President and Chief Executive Officer, have service contracts with
Biacore providing for benefits upon termination of employment, see Note 20 of
Notes to Financial Statements.
As permitted by Swedish and Unites States laws and regulations and
the Company's agreement with the Nasdaq Stock Market, the Company has no audit
committee as defined by United States laws and regulations. Similar duties are
handled by the company's shareholders' meetings and Board of Directors. Biacore
has had no compensation committee before 2003 (see Note 20 of Notes to Financial
Statements). Corresponding functions were handled by the Shareholders' Meetings
and the Board of Directors of Biacore. The current members of the compensation
committee are Lars-Goran Andren, Gordon Edge and Tom Erixon.
D. EMPLOYEES
At year-end 2002, Biacore had 325 permanent employees, an increase of
37 people from 2001.
The following table shows the number of employees at year-end broken down
by main category of activity:
Function 2002 2001 2000
Production 41 37 27
Marketing 143 128 110
Management 32 30 22
Research and development 109 93 69
Number of employees at year end 325 288 228
The number of employees has continued to grow, notably in the research and
development and marketing areas. The increase in the number of employees in
research and development is partly related to the SPR array project. Biacore's
marketing function has been expanded in all regions, notably in the United
States.
The sophistication of Biacore's products and the advanced research and
development activities conducted place high demands on Biacore to recruit and
retain highly educated and competent employees. Of the 325 Biacore employees at
year-end 2002, 40 held a Ph.D. degree. A further 145 held a bachelor's or
higher degree, and 68 had other forms of tertiary education. These highly
skilled people are from a large number of disciplines, bringing to Biacore the
broad base of knowledge that is needed to develop, produce and market Biacore(r)
systems and other products and services. Biacore's research and development team
encompasses people highly skilled in biology, chemistry, physics, mechanics,
electronics and software programming.
Biacore believes that its labor relations are good.
See also Item 3D "Risk Factors - Key Personnel," Item 3D "Risk Factors -
Ability to Attract and Retain Skilled Staff," Item 4B "Business Overview" and
Note 20 of Notes to Financial Statements.
E. SHARE OWNERSHIP
The ownership of shares in Biacore at December 31, 2002 among the Directors
of the Board and other members of senior management is presented in the table
below.
Name Function Shares (1) Options
Lars-Goran Andren Chairman of the Board 2,281 47,000
Donald R. Parfet Deputy Chairman of the Board 24,500 -
Gordon Edge Director - -
Tom Erixon Director - -
Ulf Jonsson Director, Chief Executive Officer
and President 1,100 33,000
Magnus Lundberg Director from May 2002 - -
Mats Pettersson Director 100 -
Marc Van Regenmortel Director 400 -
Anna Hansson Director (employee representative) - 1,500
Markku Hamalainen Director (employee representative) 281 3,000
Eva-Lotta Hedstrom Deputy Director from May 2002
(employee representative) - 500
Hans Sjobom Deputy Director (employee
representative) 46 2,750
George Van der Veer Deputy Director to May 2002
(employee representative) N/a N/a
Lars-Olov Forslund Executive Vice President and
Chief Financial Officer - 20,000
Anders Svenberg Executive Vice President and
Head of Human Resources - 20,000
(1) Each of these holdings represents less than 1% of the total number of
shares.
Certain other information on stock options granted to employees is
presented in Note 20 of Notes to Financial Statements.
ITEM 7. MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS
A. MAJOR SHAREHOLDERS
The following table sets forth, as at December 31, 2002, the total number
of Ordinary Shares owned by each shareholder whose ownership of Ordinary Shares
exceeds 5% of the ordinary shares issued and outstanding on such date.
Title of class Identity of person or group Amount owned Percent of class
Ordinary Shares Pharmacia AB (Pfizer) 4,000,000 41.0%
Excluding changes in shareholdings in Biacore below the 5% level, and based
mainly on statistics of shareholdings in Biacore at December 31, 1999, 2000,
2001 and 2002, Biacore knows of no significant change in the ownership of
Biacore during the three-year period between 2000 and 2002 or after December 31,
2002, apart from the merger between Pfizer Inc. and Pharmacia Corporation
(Parent company of Pharmacia AB) on April 16, 2003.
All shares carry equal voting rights.
According to records available or partly available to Biacore, at
December 31, 2002, approximately 3% of the holders of Ordinary Shares, including
the Ordinary Shares represented by American Depositary Shares, holding
approximately 8% of the total number of Ordinary Shares, were registered in
names with addresses in the United States.
To the extent known to Biacore, no entity or natural person owns a majority
of or controls Biacore.
B. RELATED PARTY TRANSACTIONS
See Item 3D "Risk Factors," 4B "Business Overview - Geographical Markets
and Marketing Organization" and Notes 2 and 20 of Notes to Financial Statements.
C. INTERESTS OF EXPERTS AND COUNSEL
Not applicable.
ITEM 8. FINANCIAL INFORMATION
A. CONSOLIDATED STATEMENTS AND OTHER FINANCIAL INFORMATION
See also the Financial Statements.
EXPORTS
Total export sales from Sweden in 2002 was SEK 423.3 million. See also
Note 17 of Notes to Financial Statements.
LEGAL OR ARBITRATION PROCEEDINGS
For a description of a legal proceeding brought by Biacore against Thermo
BioAnalysis Corp. for patent infringement, see Item 5A "Operating Results - Year
Ended December 31, 2002 Compared with 2001 - Other Operating Income."
Biacore is not a party to, and is not aware of, any significant current,
pending or contemplated legal or arbitration proceeding involving any material
claim against it.
DIVIDENDS
According to the Swedish Companies Act, dividends are decided by the
General Meetings of shareholders, and Biacore has no predetermined policy on
dividend distributions.
Before 2003, Biacore International AB never declared or paid any dividend.
For the financial year 2002, the Board of Directors of Biacore stated that
"Reflecting Biacore's continued strong cash flow, the Board will recommend to
the Annual General Meeting that the Company begins to pay dividends to its
shareholders. For the financial year 2002 the Board will recommend a dividend
payment of SEK 3.00 per share." The Annual General Meeting held on May 8, 2003
decided in accordance with the recommendation of the Board of Directors and the
dividend was paid on May 16, 2003.
B. SIGNIFICANT CHANGES
See Note 22 of Notes to Financial Statements.
ITEM 9. THE [OFFER AND] LISTING
A. [OFFER AND] LISTING DETAILS
The Ordinary Shares are listed for trading in the form of American
Depositary Shares on Nasdaq National Market and in the form of Ordinary Shares
on the Attract 40 section of the O-list of the Stockholm Stock Exchange. The
principal trading market for the Ordinary Shares is the Stockholm Stock
Exchange. Biacore shares were traded on 248 of the 250 trading days on the
Stockholm Stock Exchange, and on 197 of 253 trading days on Nasdaq. The combined
turnover rate was 156%, 46% and 41% for the years ending December 31, 2000, 2001
and 2002, respectively. Average volumes per trading day and trading market are
presented in the following table.
Average daily volume Year ended December 31
2002 2001 2000
Stockholm Stock Exchange 13,600 16,500 55,900
Nasdaq National Market 2,300 1,400 4,600
The following are yearly, quarterly and monthly high, low and last paid
sales prices of the American Depositary Shares on Nasdaq and the Ordinary Shares
on the Stockholm Stock Exchange.
Nasdaq (USD) Stockholm Stock Exchange (SEK)
High (1) Low (1) Period end High Low Period end
1998 11.75 5.25 10.50 91.0 40.0 85.0
1999 11.88 7.25 9.75 96.5 59.0 78.0
2000 45.34 9.00 45.34 460.0 71.0 430.0
2001 43.00 19.00 32.00 435.0 191.0 340.0
2002 32.75 11.95 22.40 340.0 113.0 184.0
2001Q1 43.00 28.00 28.00 425.0 295.0 310.0
2001Q2 42.00 28.00 35.31 435.0 290.0 405.0
2001Q3 39.00 19.00 23.25 425.0 191.0 245.0
2001Q4 32.25 21.00 32.00 343.0 215.0 340.0
2002Q1 32.75 22.05 23.71 340.0 232.0 255.0
2002Q2 27.80 22.40 27.12 285.0 218.0 254.5
2002Q3 28.04 11.95 11.95 256.0 113.0 119.5
2002Q4 24.74 11.95 22.40 229.5 115.5 184.0
2003Q1 23.00 19.01 21.20 198.0 156.0 167.5
2002, Dec. 22.75 21.50 22.40 206.0 174.5 184.0
2003, Jan. 23.00 20.99 21.30 198.0 175.0 180.0
2003, Feb. 22.01 19.49 19.49 187.0 156.0 166.0
2003, Mar. 21.20 19.01 21.20 174.5 163.0 167.5
2003, Apr. 24.03 19.50 24.03 199.0 160.0 196.0
2003, May 24.92 19.65 22.69 200.0 142.0 180.0
(1) Based on the last share price paid each day.
B. PLAN OF DISTRIBUTION
Not applicable.
C. MARKETS
See Item 9A "[Offer and] Listing Details."
D. SELLING SHAREHOLDERS
Not applicable.
E. DILUTION
Not applicable.
F. EXPENSES OF THE ISSUE
Not applicable.
ITEM 10. ADDITIONAL INFORMATION
A. SHARE CAPITAL
Not applicable.
B. MEMORANDUM AND ARTICLES OF ASSOCIATION
There are currently no limitations, either under the laws of Sweden or in
the articles of association of Biacore, on the rights of non-residents to hold
or vote Ordinary Shares. See also "Dividends and Dividend Policy" and
"Description of Ordinary Shares" in Form F-1 dated November 6, 1996, as amended,
and Appendix to Form 20-F for the financial year ended December 31, 1999.
C. MATERIAL CONTRACTS
During the two years immediately preceding filing of this document, Biacore
has been a party to one contract which management believes is material and which
has not been entered in the ordinary course of business or disclosed in Notes 20
or 22 of Notes to Financial Statements. That contract was dated March 14, 1997,
was filed as an exhibit to Biacore's 1996 Form 20-F and concerns the acquisition
of the Japanese sales operation from Pfizer (Pharmacia), see Note 5 of Notes to
Financial Statements. The parties to the contract were Biacore AB, Biacore KK
and Amersham Biosciences KK.
D. EXCHANGE CONTROLS
There are currently no Swedish foreign exchange control restrictions on
the conduct of Biacore's operations or affecting the remittance of dividends on
unrestricted shareholders' equity.
E. TAXATION
General
The following is a summary of certain United States federal income and
Swedish tax consequences of the ownership of Ordinary Shares or ADSs by an
investor that holds such Ordinary Shares or ADSs as capital assets for tax
purposes. This summary does not purport to address all material tax consequences
of the ownership of Ordinary Shares or ADSs, and does not take into account the
specific circumstances of particular investors (such as tax-exempt entities,
certain insurance companies, dealers in securities or currencies, traders in
securities that elect to mark to market, investors liable for alternative
minimum tax, investors that actually or constructively own 10% or more of the
voting stock of Biacore, investors that hold Ordinary Shares or ADSs as part of
a straddle or a hedging or conversion transaction or investors whose functional
currency is not the U.S. dollar), some of which may be subject to special rules.
This summary is based on the tax laws of the United States (including the
Internal Revenue Code of 1986, as amended, its legislative history, existing and
proposed regulations thereunder, published rulings and court decisions) and the
laws of Sweden all as currently in effect, as well as on the Convention between
the United States and Sweden with respect to Taxes on Income (the "Income Tax
Treaty") and the Convention between the United States and Sweden with respect to
Taxes on Estate Inheritances and Gifts (the "Estate Tax Treaty"). These laws are
subject to change, possibly on a retroactive basis. In addition, the summary is
based in part upon the representations of the Depositary and the assumption that
each obligation in the Deposit Agreement and any related agreement will be
performed in accordance with its terms.
For purposes of this discussion, a "U.S. Holder" is any beneficial owner of
Ordinary Shares or ADSs that is (1) a citizen or resident of the United States,
(2) a domestic corporation, (3) an estate the income of which is subject to
United States federal income tax without regard to its source or (4) a trust if
a court within the United States is able to exercise primary supervision over
the administration of the trust and one or more United States persons have the
authority to control all substantial decisions of the trust.
The discussion does not address any aspects of United States taxation other
than federal income taxation or any aspects of Swedish taxation other than
income tax, capital tax and gift and inheritance taxation. Prospective investors
are urged to consult their tax advisors regarding the United States federal,
state and local and Swedish and other tax consequences of owning and disposing
of Ordinary Shares and ADSs. In particular, prospective investors are urged to
consult with their tax advisors whether they are eligible for the benefits of
the Income Tax Treaty and Estate Tax Treaty.
In general, and taking into account the earlier assumptions, for United
States federal income and Swedish tax purposes, holders of ADRs evidencing ADSs
will be treated as the owners of the Ordinary Shares represented by those ADSs,
and exchanges of Ordinary Shares for ADSs, and ADSs for Ordinary Shares, will
not be subject to United States federal income or to Swedish tax.
Taxation of Dividends
Swedish Taxation
In general, under Swedish tax law, dividends paid by a Swedish corporation
such as Biacore to non-residents of Sweden are subject to Swedish withholding
tax at a rate of 30%. Pursuant to the Income Tax Treaty, however, dividends paid
by Biacore to a U.S. Holder will generally be subject to Swedish withholding tax
at a reduced rate of 15%, provided that the U.S. Holder is not a resident of
Sweden and does not have a permanent establishment or a fixed base in Sweden.
U.S Holders of ADSs or Ordinary Shares may be required to provide documentary
evidence that such holder is entitled to the reduced 15% withholding tax rate
under the Income Tax Treaty. The Depositary or the Custodian will, to the extent
practicable, facilitate all administrative actions necessary to obtain the
reduced 15% withholding tax rate at source or obtain refunds of Swedish
withholding taxes for U.S. Holders of ADSs. The Securities Register Center (VPC)
generally deducts withholding tax on dividends. If the Ordinary Shares are
registered with a nominee, the nominee is under a duty to deduct the withholding
tax.
United States Federal Income Taxation
Under the United States federal income tax laws, and subject to the passive
foreign investment company ("PFIC") rules discussed below, the gross amount of
any dividend paid to a U.S. Holder (before reduction for Swedish withholding
taxes) by Biacore out of its current or accumulated earnings and profits (as
determined for United States federal income tax purposes) is subject to United
States federal income taxation. Dividends paid to a noncorporate U.S. Holder
after December 31, 2002 and before January 1, 2009 that constitute qualified
dividend income will be taxable to the holder at a maximum tax rate of 15%
provided that the Ordinary Shares or ADSs are held for more than 60 days during
the 120 day period beginning 60 days before the ex-dividend date and the holder
meets other holding period requirements. Dividends paid with respect to the
Ordinary Shares or ADSs will be qualified dividend income. The dividend is
taxable to the U.S. Holder when it is actually or constructively received by the
U.S. Holder, in the case of Ordinary Shares, or by the Depositary, in the case
of ADSs. The dividend will not be eligible for the dividends-received deduction
generally allowed to United States corporations in respect of dividends received
from other United States corporations. The amount of the dividend distribution
includible in income of a U.S. Holder will be the U.S. dollar value of the krona
payments made, determined at the spot krona/U.S. dollar rate on the date such
dividend distribution is includible in the income of the U.S. Holder, regardless
of whether the payment is in fact converted into U.S. dollars. Generally, any
gain or loss resulting from currency exchange fluctuations during the period
from the date the dividend payment is includible in income to the date such
payment is converted into U.S. dollars will be treated as ordinary income or
loss and will not be eligible for the special tax rate applicable to qualified
dividend income. Such gain or loss generally will be income from sources within
the United States for foreign tax credit limitation purposes. Distributions in
excess of current and accumulated earnings and profits, as determined for United
States federal income tax purposes, will be treated as a return of capital to
the extent of the U.S. Holder's basis in the Ordinary Shares or ADSs and
thereafter as capital gain.
Subject to certain limitations, the Swedish tax withheld in accordance with
the Income Tax Treaty and paid over to Sweden will be creditable against the
U.S. Holder's United States federal income tax liability. To the extent a refund
of the tax withheld is available to a U.S. Holder under the laws of Sweden or
under the Income Tax Treaty, the amount of tax withheld that is refundable will
not be eligible for credit against the U.S. Holder's United States federal
income tax liability. Special rules apply in determining the foreign tax credit
limitation with respect to dividends that are subject to the maximum 15% tax
rate.
For foreign tax credit limitation purposes, the dividend will be income
from sources without the United States, but generally will be "passive income"
(or, in the case of certain holders, "financial services income") which is
treated separately from other types of income for purposes of computing the
foreign tax credit available to the U.S. Holder. In addition, special rules will
apply in determining the foreign tax credit limitation with respect to
dividends.
Taxation of Capital Gains
Swedish Taxation
In general, under the Income Tax Treaty, a U.S. Holder will not be subject
to Swedish tax on any gains derived from the sale or other disposition of ADSs
or Ordinary Shares, provided that the U.S. Holder is not a resident of Sweden
and does not have a permanent establishment or a fixed base in Sweden. Special
rules may, however, apply to persons whom were residents of Sweden within the
ten year period immediately preceding such sale or other disposition.
United States Federal Income Taxation
Subject to the PFIC rules discussed below, upon a sale or other disposition
of Ordinary Shares or ADSs, a U.S. Holder will recognize gain or loss for United
States federal income tax purposes in an amount equal to the difference between
the U.S. dollar value of the amount realized and the U.S. Holder's tax basis
(determined in U.S. dollars) in such Ordinary Shares or ADSs. Capital gain of a
noncorporate U.S. Holder that is recognized on or after May 6, 2003 and before
January 1, 2009 is generally taxed at a maximum rate of 15% where the property
is held for more than one year. The gain or loss generally will be income or
loss from sources within the United States for foreign tax credit limitation
purposes.
PFIC rules
Biacore believes that Ordinary Shares and ADSs should not be treated as
stock of a PFIC for United States federal income tax purposes, but this
conclusion is a factual determination made annually and thus may be subject to
change. If Biacore were to be treated as a PFIC, unless a U.S. Holder elects to
be taxed annually on a mark-to-market basis with respect to the Ordinary Shares
or ADSs, gain realized on the sale or other disposition of Ordinary Shares or
ADSs would in general not be treated as capital gain, and a U.S. Holder would be
treated as if such holder had realized such gain and certain "excess
distributions" ratably over the holder's holding period for the Ordinary Shares
or ADSs and would be taxed at the highest tax rate in effect for each such year
to which the gain was allocated, together with an interest charge in respect of
the tax attributable to each such year. In addition, dividends received from
Biacore will not be eligible for the special tax rates applicable to qualified
dividend income if Biacore is a PFIC either in the taxable year of the
distribution or the preceding taxable year, but instead will be taxable at rates
applicable to ordinary income.
Transfer and Capital Taxes
Currently there are no Swedish transfer or similar taxes imposed on sales
of shares.
Sweden imposes an annual capital tax (net wealth tax) on individuals
resident in Sweden. A U.S. Holder may be regarded as a tax resident of Sweden,
and will in such case have to pay capital tax on his net wealth, including ADSs
or Ordinary Shares. The Income Tax Treaty will in many cases exempt the U.S.
Holder from the capital tax if the U.S. Holder is a resident of the United
States in accordance with article 4 of the Income Tax Treaty.
Swedish Gift and Inheritance Taxes
A transfer of an Ordinary Share or an ADS by gift or by reason of the death
of the owner may be subject to Swedish gift or inheritance tax, respectively,
with the applicable progressive rates varying from 10% to 30% of the taxable
amount (determined after certain deductions), depending on the relationship of
the donee or beneficiary to the donor or decedent. Transfers of Ordinary Shares
or ADSs would be subject to Swedish inheritance tax if (1) the decedent was
resident in Sweden at the time of death, (2) the decedent had his habitual place
of abode in Sweden at the time of death, (3) the decedent was a Swedish citizen
or (4) if the decedent was married to a Swedish citizen and had emigrated from
Sweden within 10 years prior to the death. Transfers of Ordinary Shares or ADSs
would be subject to gift tax if (1) the donor is resident in Sweden when the
gift is made, (2) the donor has his habitual place of abode in Sweden when the
gift is made, (3) the donor is a Swedish citizen, (4) the donor is married to a
Swedish citizen and had emigrated from Sweden within 10 years prior to when the
gift is made, (5) the donee is a Swedish citizen or (6) either the donor or
the donee is a Swedish legal entity.
Under the Estate Tax Treaty, the transfer of an ADS or an Ordinary Share by
an individual U.S. Holder, by gift or by reason of the death of such holder,
will not be subject to Swedish gift or inheritance tax, provided that the U.S.
Holder is not a resident of Sweden and the ADS or Ordinary Share does not form
part of the business property of a permanent establishment in Sweden or pertain
to a fixed base in Sweden used for the performance of independent personal
services. In cases where such a transfer is subject to both Swedish inheritance
or gift tax and U.S. estate or gift tax, an amount equal to the tax paid to
Sweden will be credited against the U.S. tax.
Responsibility for Withholding of Tax
Biacore does not assume responsibility for withholding of tax. Swedish
Regulations concerning withholding tax are generally applied by Swedish paying
agents.
F. DIVIDENDS AND PAYING AGENTS
Not applicable.
G. STATEMENTS BY EXPERTS
Not applicable.
H. DOCUMENTS ON DISPLAY
Documents referred to on this Form 20-F may be inspected at Biacore's
office at Rapsgatan 7, Uppsala, Sweden. It is also possible to read and copy
documents referred to in this annual report on Form 20-F that have been filed
with the SEC at the SEC's public reference room located at 450 Fifth Street,
NW, Washington, D.C. 20549, United States. Please call the SEC at 1-800-SEC-0330
for further information on the public reference rooms and their copy charges. In
addition, all of Biacore's filings and submissions filed or furnished to the SEC
on or after November 4, 2002, are available on the SEC's website at www.sec.gov.
I. SUBSIDIARY INFORMATION
Not applicable.
ITEM 11. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
A. FOREIGN CURRENCY RISK
Approximately 97%, 99% and 97% of Biacore's sales in 2000, 2001 and 2002,
respectively, were derived from customers located outside Sweden and were
generally denominated in currencies other than the Swedish krona, including the
U.S. dollar, the Japanese yen, the British pound and the euro. Selling
operations are conducted through Biacore's own marketing branches in Europe,
New Zealand and Australia; subsidiaries in the United States and Japan; and
distributors in certain other countries. Production and research and development
are mainly carried out in Sweden. Biacore International SA in Switzerland acts
as Biacore's head office and commercial center.
Because of the proportion of international activity, Biacore's income is
exposed to exchange rate fluctuations. Risks of two kinds arise as a result: a
transaction risk, that is, the risk that currency fluctuations will have a
negative effect on the value of Biacore's cash flows in various currencies; and
a translation risk, that is, the risk of adverse currency fluctuations in the
translation of foreign operations and foreign assets and liabilities into
Swedish kronor for Biacore's financial statements. Because of Biacore's
operations in Sweden, Biacore has larger expenses than revenues denominated in
Swedish kronor. Similarly, Biacore has more foreign currency denominated assets
than liabilities. As a result, depreciation of the Swedish krona would tend to
improve Biacore's operating income margins while appreciation of the Swedish
krona would have the opposite effect. The expense for purchases of production
inputs from outside Sweden is small. See also Item 3A "Selected Financial
Data - Exchange Rates."
The primary market risk exposure of Biacore is the exchange of foreign
sales revenues from the United States, Japan and the euro region to Swedish
kronor.
Biacore's net income is also subject to currency gains and losses on
certain intercompany receivables and liabilities. Such currency exposure is
mainly concentrated to its commercial center i Switzerland, and changes in the
currency exchange rates between the Swiss franc and other currencies may
materially affect Biacore's net income.
It is not possible to hedge against all currency risks to which Biacore is
exposed, and fluctuations between local currencies and the Swedish krona may
have an adverse effect on Biacore's financial condition and results of
operations.
In the normal course of business, Biacore seeks to mitigate transaction
risk by entering from time to time into forward exchange contracts through which
Biacore, in exchange for Swedish kronor, sells forward the major foreign
currencies forecast to be received by it in connection with sales outside of
Sweden. Biacore has not historically hedged against currency translation risk
and does not currently intend to do so in the future.
The only derivative financial instruments Biacore uses are forward foreign
exchange contracts, which are mainly used to hedge currency risk in sales. For a
description of insurance contracts against social security costs on stock
options accounted for as a derivative instrument under U.S. GAAP, see Notes 19
and 23 of Notes to Financial Statements.
Biacore does not engage in or sell forward contracts for trading purposes.
The following table specifies the forward foreign exchange contracts
entered by Biacore.
As of December 31
2002 2002 2002 2001 2001 2001 2000 2000 2000
000's Con- Con- Esti- Con- Con- Esti- Con- Con- Esti-
tractual tractual mated tractual tractual mated tractual tractual mated
amount, amount, fair amount, amount, fair amount, amount, fair
local SEK value, local SEK value, local SEK value,
currency SEK currency SEK currency SEK
USD 11,579 112,383 9,134 5,766 61,474 -357 3,424 31,826 -493
JPY 521,000 40,914 2,130 721,000 61,914 2,588 644,000 58,435 4,437
Other N/a 18,373 82 N/a 14,048 -112 N/a 8,467 -353
Total N/a 171,670 11,346 N/a 137,436 2,119 N/a 98,728 3,591
Sweden is not among those countries whose currencies since January 1,
1999 make up the euro, the main currency of the European Union.
ITEM 12. DESCRIPTION OF SECURITIES OTHER THAN EQUITY SECURITIES
Not applicable.
PART II
ITEM 13. DEFAULTS, DIVIDEND ARREARAGES AND DELINQUENCIES
None.
ITEM 14. MATERIAL MODIFICATIONS TO THE RIGHTS OF SECURITY HOLDERS AND USE OF
PROCEEDS
None.
ITEM 15. CONTROLS AND PROCEDURES
Under the supervision and with the participation of the Company's
management, including the Company's Chief Executive Officer and Chief Financial
Officer, the Company has evaluated the effectiveness of the design and operation
of its disclosure controls and procedures pursuant to Exchange Act
Rule 13a-14(c) within 90 days of the filing date of this annual report. Based on
that evaluation, the Chief Executive Officer and Chief Financial Officer have
concluded that these disclosure controls and procedures are effective.
In designing and evaluating our disclosure controls and procedures, our
management, including the Chief Executive Officer and Chief Financial Officer,
recognized that any controls and procedures, no matter how well designed and
operated, can provide only reasonable assurance of achieving the desired control
objectives, and our management necessarily was required to apply its judgement
in evaluating the cost-benefit relationship of possible controls and procedures.
Because of the inherent limitations in all control systems, no evaluation of
controls can provide absolute assurance that all control issues and instances of
fraud, if any, within the Company have been detected.
There were no significant changes in the Company's internal controls or in
other factors that could significantly affect internal controls subsequent to
the date of their most recent evaluation.
ITEM 16A. AUDIT COMMITTEE FINANCIAL EXPERT
Not applicable.
ITEM 16B. CODE OF ETHICS
Not applicable.
ITEM 16C. PRINCIPAL ACCOUNTANT FEES AND SERVICES
Not applicable.
ITEM 16D. EXEMPTIONS FROM THE LISTING STANDARDS FOR AUDIT COMMITTEES
Not applicable.
PART III
ITEM 17. FINANCIAL STATEMENTS
CONTENTS
Report of Independent Accountants
Consolidated Income Statements
Consolidated Balance Sheets
Consolidated Statements of Cash Flows
Notes to Financial Statements
REPORT OF INDEPENDENT ACCOUNTANTS
To the Board of Directors and Shareholders of Biacore International AB:
We have audited the accompanying consolidated balance sheets of Biacore
International AB and Subsidiaries, collectively "Biacore," (as described in
Note 1), as of December 31, 2002, 2001 and 2000, respectively, and the related
consolidated income statements and statements of cash flows for each of the
three years in the period ended December 31, 2002, all expressed in Swedish
kronor. These financial statements are the responsibility of Biacore'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 in the United States. Those standards require that we plan and
perform our audits to obtain reasonable assurance about whether the financial
statements are free of material misstatement. An audit includes examining, on a
test basis, evidence supporting the amounts and disclosures in the financial
statements. An audit also includes assessing the accounting principles used and
significant estimates made by management, as well as evaluating the overall
financial statement presentation. We believe that our audits provide a
reasonable basis for our opinion.
In our opinion, the financial statements referred to above present fairly,
in all material respects, the financial position of Biacore at December 31,
2002, 2001 and 2000, and the results of its operations and cash flows for each
of the three years in the period ended December 31, 2002, (on the basis
described in Note 1), in conformity with accounting principles generally
accepted in Sweden.
Accounting principles generally accepted in Sweden vary in certain
significant respects from accounting principles generally accepted in the United
States. Application of accounting principles generally accepted in the United
States would have affected the determination of consolidated net income
expressed in Swedish kronor for each of the three years in the period ended
December 31, 2002 and the determination of consolidated shareholders' equity and
consolidated financial position also expressed in Swedish kronor at December 31,
2002, 2001 and 2000 to the extent summarized in Note 23 to the consolidated
financial statements.
Stockholm, Sweden
March 26, 2003
Goran Tidstrom Sten Hakansson
Authorized Public Accountant Authorized Public Accountant
PricewaterhouseCoopers AB PricewaterhouseCoopers AB
BIACORE
CONSOLIDATED INCOME STATEMENTS
(in thousands, except earnings per share)
For the years ended December 31
2002 2002 2001 2000
USD SEK SEK SEK
Sales 70,633 614,154 543,717 438,820
Cost of goods sold -11,608 -100,930 -99,800 -78,096
Gross profit 59,025 513,224 443,917 360,724
Marketing -22,981 -199,817 -188,696 -147,383
Administration -7,852 -68,271 -86,739 -60,827
Research and development -12,003 -104,370 -104,667 -72,760
Operating foreign currency gains and losses -1,914 -16,644 4,539 3,167
Other operating income 2,413 20,982 742 9
Other operating expenses -1 -10 - -
Amortization of goodwill -519 -4,515 -4,964 -4,956
Operating income 16,168 140,579 64,132 77,974
Gain on sale of long-term investments - - 4,605 -
Write-downs of long-term investments -3,296 -28,655 - -
Interest income 1,168 10,158 9,981 8,411
Interest expense -210 -1,833 -1,055 -1,054
Financial foreign currency gains and losses -2 -16 199 1,326
Other financial income and expenses - - -5 -
Financial items, net -2,340 -20,346 13,725 8,683
Income after financial items 13,828 120,233 77,857 86,657
Income taxes -4,611 -40,096 -27,588 -27,536
Minority interest 71 623 - -
Net income 9,288 80,760 50,269 59,121
Basic earnings per share 0.95 8.28 5.16 6.06
Diluted earnings per share 0.94 8.20 5.04 6.02
No. of shares, average, thousands 9,750 9,750 9,750 9,750
No. of shares, average, diluted, thousands 9,851 9,851 9,981 9,817
Solely for the convenience of the reader, the 2002 financial statements
have been translated into United States Dollars (USD) using the December 31,
2002 Noon Buying Rate of the Federal Reserve Bank of New York of
USD 1 = SEK 8.6950. Such translated amounts are unaudited.
See accompanying notes to financial statements.
BIACORE
CONSOLIDATED BALANCE SHEETS
(in thousands)
As of December 31
2002 2002 2001 2000
USD SEK SEK SEK
ASSETS
Long-term assets
Capitalized product development 583 5,070 - -
Goodwill 1,977 17,190 23,589 28,969
Other intangible assets 7,197 62,581 60,717 3,814
Intangible assets 9,757 84,841 84,306 32,783
Buildings 9,113 79,240 59,662 53,025
Land and land improvements 714 6,208 6,246 6,314
Machinery and equipment 3,645 31,692 41,717 24,060
Property, plant and equipment 13,472 117,140 107,625 83,399
Long-term investments 911 7,920 40,470 68,025
Long-term receivables 3,183 27,672 28,681 22,800
Long-term financial assets 4,094 35,592 69,151 90,825
Total long-term assets 27,323 237,573 261,082 207,007
Current assets
Inventories 4,998 43,460 29,449 23,152
Accounts receivable 17,974 156,280 179,096 125,507
Other receivables 4,891 42,529 40,499 20,350
Receivables 22,865 198,809 219,595 145,857
Marketable securities 31,448 273,443 184,838 196,688
Cash and bank 8,988 78,146 35,970 71,065
Liquid funds 40,436 351,589 220,808 267,753
Total current assets 68,299 593,858 469,852 436,762
Total assets 95,622 831,431 730,934 643,769
Solely for the convenience of the reader, the 2002 financial statements
have been translated into United States Dollars (USD) using the December 31,
2002 Noon Buying Rate of the Federal Reserve Bank of New York of
USD 1 = SEK 8.6950. Such translated amounts are unaudited.
See accompanying notes to financial statements.
BIACORE
CONSOLIDATED BALANCE SHEETS
(in thousands)
As of December 31
2002 2002 2001 2000
USD SEK SEK SEK
SHAREHOLDERS' EQUITY AND LIABILITIES
Shareholders' equity
Share capital 11,213 97,500 97,500 97,500
Restricted reserves 29,201 253,904 245,821 236,831
Restricted shareholders' equity 40,414 351,404 343,321 334,331
Unrestricted reserves 23,291 202,506 175,645 100,679
Net income 9,288 80,760 50,269 59,121
Unrestricted shareholders' equity 32,579 283,266 225,914 159,800
Total shareholders' equity 72,993 634,670 569,235 494,131
Minority interest 98 853 - -
Provisions
Provision for pensions 3,835 33,347 27,750 24,171
Provision for long-term deferred taxes 5,571 48,436 34,799 28,113
Provision for short-term deferred taxes - - - 530
Other provisions 186 1,622 1,622 1,622
Total provisions 9,592 83,405 64,171 54,436
Long-term liabilities
Long-term liabilities to
credit institutions, 1-5 years 378 3,291 - -
Current liabilities
Current liabilities to credit institutions 117 1,013 - -
Accounts payable 3,004 26,122 26,796 30,431
Income taxes payable 146 1,270 1,865 5,440
Other liabilities 9,294 80,807 68,867 59,331
Total current liabilities 12,561 109,212 97,528 95,202
Total shareholders' equity and liabilities 95,622 831,431 730,934 643,769
Pledged assets and contingent liabilities
Pledged assets None None None None
Contingent liabilities 62 535 4,738 4,370
Solely for the convenience of the reader, the 2002 financial statements
have been translated into United States Dollars (USD) using the December 31,
2002 Noon Buying Rate of the Federal Reserve Bank of New York of
USD 1 = SEK 8.6950. Such translated amounts are unaudited.
See accompanying notes to financial statements.
BIACORE
CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
For the years ended December 31
2002 2002 2001 2000
USD SEK SEK SEK
Cash flows from operating activities
Net income 9,288 80,760 50,269 59,121
Less: Depreciation and amortization 2,731 23,743 20,511 19,408
Less: Gain on sale of long-term investments - - -4,605 -
Less: Write-down of long-term investments 3,296 28,655 - -
Less: Minority interest -72 -623 - -
Decrease (increase) in long-term deferred
tax assets 193 1,680 -5,428 -6,640
Decrease (increase) in other long-term
receivables -77 -671 -453 -409
Decrease (increase) in inventories -1,678 -14,586 -4,478 -2,171
Decrease (increase) in accounts receivable 2,624 22,816 -53,589 -2,804
Decrease (increase) in income tax receivables -356 -3,096 -496 13,861
Decrease (increase) in current deferred tax
assets 155 1,350 -1,658 -265
Decrease (increase) in other receivables -33 -284 165 -5,188
Increase (decrease) in provision for pensions 644 5,597 3,579 3,169
Increase (decrease) in provision for
long-term deferred taxes 1,568 13,637 6,686 6,071
Increase (decrease) in provision for
short-term deferred taxes - - -530 530
Increase (decrease) in other provisions - - - 122
Increase (decrease) in accounts payable -78 -674 -3,635 9,751
Increase (decrease) in income taxes payable -68 -595 -3,575 -15,856
Increase (decrease) in other liabilities 1,373 11,940 9,536 13,681
Other -688 -5,986 6,086 5,905
Net cash flow from operating activities 18,822 163,663 18,385 98,286
Cash flows from investing activities
Acquisition of businesses, net of
payments made and cash in entities acquired 183 1,594 - -764
Purchase of other intangible assets -799 -6,951 -57,511 -15
Purchase of property, plant and equipment -3,653 -31,764 -39,979 -14,236
Proceeds from sale of property, plant and
equipment - - - 1,543
Purchase of long-term investments - - - -50,811
Proceeds from sale of long-term investments - - 32,160 -
Net cash flow from investing activities -4,269 -37,121 -65,330 -64,283
Cash flows from financing activities
Long-term borrowing 459 3,990 - -
Short-term borrowing 115 997 - -
Repayment of loan -86 -748 - -7,928
Net cash flow from financing activities 488 4,239 - -7,928
Net increase (decrease) in liquid funds 15,041 130,781 -46,945 26,075
Liquid funds at beginning of year 25,395 220,808 267,753 241,678
Liquid funds at end of year 40,436 351,589 220,808 267,753
Solely for the convenience of the reader, the 2002 financial statements
have been translated into United States Dollars (USD) using the December 31,
2002 Noon Buying Rate of the Federal Reserve Bank of New York of
USD 1 = SEK 8.6950. Such translated amounts are unaudited.
See accompanying notes to financial statements.
NOTES TO FINANCIAL STATEMENTS
Amounts in these Notes to Financial Statements are in thousands of Swedish
kronor, except per share and other data, unless stated otherwise.
1. ACCOUNTING POLICIES
Basis of Presentation
References to "Biacore" or the "Group" in these notes to the financial
statements pertain to Biacore International AB and its subsidiaries in
accordance with the description below, unless specifically indicated otherwise.
Biacore develops, manufactures and markets advanced scientific instruments that
utilize optical measurement based on the quantum physical phenomenon of surface
plasmon resonance ("SPR") to measure interactions between biomolecules in
scientific research laboratories and in the pharmaceutical, diagnostics,
biotechnology, and food and beverage industries.
The accompanying financial statements have been prepared in accordance with
accounting principles generally accepted in Sweden ("Swedish GAAP"). These
accounting principles differ in certain significant respects from accounting
principles generally accepted in the United States ("U.S. GAAP"). See Note 23
for a reconciliation of the principal differences between Swedish GAAP and U.S.
GAAP affecting Biacore's income and shareholders' equity.
Consolidation Principles
The consolidated financial statements include the parent company Biacore
International AB and all entities in which Biacore International AB, directly or
indirectly, holds more than 50% of the voting rights.
All business combinations have been accounted for in accordance with the
purchase method. Companies acquired are included as from the date of
acquisition.
The effects of all significant transactions between the consolidated
entities have been eliminated.
Changes in Accounting Principles
Apart from RR15 Intangible Assets, those new accounting standards from the
Swedish Financial Accounting Standards Council ("Redovisningsradet") which
applied as from 2002 did not affect Biacore's income statement or balance sheet.
RR15 Intangible Assets has affected the financial statements. It requires that
product development expenses that fulfil certain criteria, but not other
research and development expenses, be stated as assets and amortized over their
estimated economic life. Prior to 2002, such items were charged to expenses as
they occurred. The recording of these items during 2002 is described in Note 5.
RR15 is only applied prospectively. Thus, earnings during 2002 and thereafter is
not charged with amortization of expenses from periods before January 1, 2002
which would have been stated as assets and amortized if RR15 had been applied in
prior years. RR22 Presentation of Financial Statements, RR25 Segment Reporting
and RR27 Financial Instruments: Disclosure and Presentation from the Swedish
Financial Accounting Standards Council are effective for financial years
beginning January 1, 2003 or later. Biacore does not expect the impact of the
adoption of these accounting standards to be material to its financial
statements. RR29 Employee Benefits is effective for financial years beginning
January 1, 2004 or later. Biacore does not expect the impact of the adoption of
this accounting standard to be material to its income statement or balance
sheet, but will further assess its impact at a later date.
Foreign Currency Translation
Assets and liabilities of foreign entities are translated at year-end
exchange rates to Swedish kronor. Income statements are translated at the
average exchange rate for the period. Translation differences that arise are
recorded directly in shareholders' equity.
Receivables and liabilities denominated in foreign currencies are
translated at year-end exchange rates. Unrealized exchange gains and losses are
reported in the income statement. Exchange gains and losses on operating assets
and liabilities are reported within operating income, while exchange gains and
losses on financial assets and liabilities are reported within financial items,
net.
Research and Development
Product development costs relating to projects which the Company can show
it can technologically complete and profitably commercialize, and which fulfil
certain other criteria listed by the Swedish Financial Accounting Standards
Council, are stated as assets and are amortized in accordance with "Amortization
and Depreciation" below. Other research and development costs are expensed as
incurred. See also "Changes in Accounting Principles" in this Note 1 of Notes to
Financial Statements.
Other Intangible Assets, and Property, Plant and Equipment
Other intangible assets, and property, plant and equipment, excluding land,
are recorded at acquisition cost less accumulated amortization and depreciation.
Land is recorded at acquisition cost. If there is indication of an impairment of
an intangible asset or a property, plant or equipment, then the recoverable cost
of the asset is calculated. If the recoverable cost is less than the carrying
amount of the asset, a write-down to the recoverable amount is recorded.
Long-Term Investments
Shares in companies in which Biacore holds less than 20% of the voting
rights, and other long-term investments, are carried at cost. The recorded
values of long-term investments are written down when impairment in value is
other than temporary.
Inventories
Inventories are accounted for in accordance with the first-in, first-out
(FIFO) method. Raw materials and work in progress are valued at the lower of
cost or replacement cost, while finished products are valued at the lower of
cost or net sales value. Detailed inventory aging reports for all significant
inventoried products are maintained and reviewed, and obsolescence is provided
for.
Liquid Funds
Liquid funds include interest-bearing investments with high liquidity and
low risk. Treasury bills and commercial paper are accounted for using the
amortized cost method.
Revenue Recognition
Sales are recognized when no significant vendor obligation remains and
collection of the resulting receivable is probable, which generally takes place
at shipment or delivery as title transfers to the customer.
Revenue from maintenance contracts is recognized ratably over the term of
the contracts. Unrecognized revenue relating to maintenance contracts is
recorded as deferred revenue, which is included in other liabilities in the
balance sheet.
Warranty Costs
Biacore provides, by a current charge to the income statement, an amount it
estimates will be needed to cover future warranty obligations for products sold
during the year. The accrued liability for warranty costs is included in other
provisions in the balance sheet.
Employee Stock options
At exercise of employee stock options, the exercise price of the options
increases the liquid funds and shareholders' equity of the Company. The number
of shares is also increased. Prior to exercise, the option plans are disclosed
and earnings per share is adjusted to account for the estimated dilutive effect
of employee stock options. Social security costs relating to employee stock
options are charged to expenses over the option periods.
Amortization and Depreciation
Amortization and depreciation are calculated using the straight-line
method. Such amounts are calculated based on acquisition cost using estimates of
economic life.
Capitalized product development is amortized over its individually
estimated useful life, starting when the respective products are ready for first
delivery.
Goodwill is amortized over a maximum of 20 years. Goodwill arising from
acquisition of sales organizations with established market positions is
amortized over 5 to 12 years based on individual assessments.
Licenses and patents are amortized over the shorter of their legal life and
their individually estimated useful life.
Permanent buildings are depreciated over 25 to 50 years, mobile office
units 10 years, land improvements 20 years, installations in buildings up to 20
years and other machinery and equipment over 3 to 10 years.
Property, plant and equipment are depreciated from the date the assets are
put into service.
Foreign Exchange Contracts
The only derivative financial instruments Biacore uses are forward foreign
exchange contracts, which are mainly used to hedge currency risk in sales. See
also Note 23 - Hedge on Social Security Costs of Stock Options.
Both gains and losses from hedges of sales are reported in the same period
as the corresponding sales. Thus, unrealized gains and losses on forward foreign
exchange contracts entered into for purposes of hedging sales are not recognized
until the underlying sales are recorded.
At hedging of intercompany loans, the loan is reported at the secured
value. Any premium is amortized over the period of the hedge and included in
interest income.
Biacore does not engage in or sell forward contracts for trading purposes.
Income Taxes
Income taxes include payable and deferred income taxes arising as a result
of temporary differences between financial and tax reporting. Deferred income
tax liabilities and assets are recorded at the enacted tax rates of the
respective countries in accordance with the liability method. Deferred income
tax liabilities and assets are offset only for entities within the same tax
jurisdiction.
A deferred income tax asset is recognized for temporary differences and tax
loss carry forwards that are expected to result in deductible amounts in future
years. A valuation allowance is recognized if it is more likely than not that
some portion or all of the deferred income tax asset will not be realized.
Use of Estimates
The preparation of financial statements 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 dates of
the financial statements and the reported amounts of revenues and expenses
during the reporting periods. Actual results could differ from those estimates.
2. RELATED PARTY TRANSACTIONS
As a result of its 41% ownership interest, Pfizer is considered to be a
related party of Biacore. During 2000 and 2001, Amersham Biosciences is
considered to have been a related party of Biacore, as it was at that time 45%
owned by Pharmacia. On April 16, 2003, The Pharmacia and Pfizer groups merged.
In these related party data, references to Pfizer before January 1, 2003 relate
to the Pharmacia Group only.
Transactions and balances with related parties are presented in the
following table.
For the years ended December 31
2002 2001 2000
Sales 15,159 9,548 5,648
Operating expenses -2,918 -9,726 -7,952
Accounts receivable 5,669 4,538 1,031
Accounts payable 598 1,244 2,221
Net receivable from related parties 5,071 3,294 -1,190
Sales to related parties represent sales to Pfizer (Pharmacia) and, during
2000 and 2001, also to Amersham Biosciences under distributor agreements with
Biacore for sales to third parties in Asia. Biacore believes that the pricing
and other sales terms provided to related parties have been no less favorable to
Biacore than could have been obtained from non-related parties.
From Pfizer, Biacore purchases canteen services, employee health care and
certain other services. From Amersham Biosciences, Biacore has purchased certain
parts and chemicals. Management believes that the costs of these goods and
services were reasonable and would not have differed significantly if they had
been purchased from unrelated third parties, and that there are alternative
suppliers for all of these goods and services.
Accounts receivable from related parties represent sales to Pfizer and
distribution companies within Amersham Biosciences.
Accounts payable to related parties represent goods and services mentioned
above purchased from Pfizer and Amersham Biosciences.
Items in the consolidated statements of cash flows which relate to
transactions with related parties are presented in the following table.
For the years ended December 31
2002 2001 2000
Cash flows from operating activities
Decrease (increase) in accounts receivable -1,131 -3,507 45,542
Increase (decrease) in accounts payable -646 -977 -4,572
Cash flows from investing activities
Acquisition of businesses, net of
payments made and cash in entities acquired - - -764
As of December 31, 2000 and 2001, Biacore owned approximately 15.8% and
4.5%, respectively, of the shares of Axiom Biotechnologies Inc. In 2001, Biacore
acquired, for a consideration of USD 5 million (SEK 53.6 million), a license to
certain fluorescent cell-based assay technology from Axiom Biotechnologies Inc.
Concurrently, Biacore sold 1,000,000 shares in Axiom Biotechnologies Inc. to
Axiom Biotechnologies Inc. for a consideration of USD 3 million. The two
transactions were negotiated simultaneously and the net amount of USD 2 million
was paid by Biacore to Axiom Biotechnologies in 2001.
3. INTEREST EXPENSE
For the years ended December 31
2002 2001 2000
Interest expense on provision for pensions -1,585 -828 -854
Other interest expenses -248 -227 -200
Interest expense -1,833 -1,055 -1,054
4. INCOME TAXES
Income after financial items was distributed geographically as follows.
For the years ended December 31
2002 2001 2000
Sweden 108,282 66,743 81,350
United States -622 13,730 17,655
Rest of world 12,573 -2,616 -12,348
Total income after financial items 120,233 77,857 86,657
Income taxes were distributed geographically as presented in the following
table.
For the years ended December 31
2002 2001 2000
Payable income taxes
Sweden -26,104 -21,344 -19,527
United States 3,840 -5,662 -6,924
Rest of world -2,513 -1,594 -1,486
Total payable income taxes -24,777 -28,600 -27,937
Deferred income taxes
Sweden -12,751 -824 -4,775
United States -3,733 1,547 581
Rest of world 1,165 289 4,595
Total deferred income taxes -15,319 1,012 401
Total income taxes -40,096 -27,588 -27,536
The principal reasons for the difference between the statutory income tax
rate in Sweden and the effective tax rate in relation to income after financial
items are set forth in the following table.
% For the years ended December 31
2002 2001 2000
Statutory income tax rate 28 28 28
Differences for foreign tax rates -4 4 1
Loss for which no deferred tax asset
is recorded - - 1
Taxes related to prior years 1 -2 -
Capital losses 7 - -
Other nondeductible costs 1 5 3
Deductibility of expenses not
previously deductible - - -1
Effective income tax rate 33 35 32
Deferred income taxes reflect the impact of temporary differences between
the basis of assets and liabilities for financial reporting purposes and such
amounts as measured by tax laws. The tax effects of temporary differences that
give rise to deferred tax assets and liabilities are presented in the following
table.
As of December 31
2002 2001 2000
Deferred tax assets
Intercompany profits 10,851 14,380 11,329
Tax loss carryforwards 16,802 20,081 19,122
Long-term investments 8,023 - -
Other 5,340 4,736 1,620
Total deferred tax assets, gross 41,016 39,197 32,071
Valuation allowance -9,539 -4,690 -4,602
Netting of deferred tax assets and
liabilities - - -48
Total deferred tax assets 31,477 34,507 27,421
Deferred tax liabilities
Tax allocation reserve 33,728 29,218 25,582
Accumulated excess depreciation 14,708 5,581 2,579
Other - - 530
Total deferred tax liabilities, gross 48,436 34,799 28,691
Netting of deferred tax assets and
liabilities - - -48
Total deferred tax liabilities 48,436 34,799 28,643
Net deferred tax liabilities 16,959 292 1,222
The deferred tax asset from tax loss carryforwards mainly relates to tax
loss carryforwards of approximately 39,995 in Japan, of which approximately
7,220 expire in 2003, approximately 15,490 in 2004, approximately 10,620 in
2005, approximately 3,691 in 2006 and approximately 2,974 in 2007. An improved
financial performance in Japan, caused by, among other factors, declining
amortization of goodwill in the Japanese legal entity, is expected to lead to
utilization of almost all of the Japanese tax loss carryforward.
The valuation allowance against deferred tax assets mainly relates to
deferred taxes on the write-down of long-term investments. The following table
summarizes the activity which has been recorded through the valuation allowance
accounts.
Valuation allowance For the years ended December 31
2002 2001 2000
Balance at beginning of period -4,690 -4,602 -4,006
Changes in tax loss carryforwards
not expected to be utilized 2,930 -52 -1,070
Write-downs of long-term investments -8,023 - -
Changes in tax rates - - 512
Currency translation differences 244 -36 -38
Balance at end of period -9,539 -4,690 -4,602
No deferred tax liability has been recorded for temporary differences
relating to investments in subsidiaries and branch offices as Biacore can
control the timing of realization of such temporary differences and it is
probable that such realization will not take place within the foreseeable
future. The total amount of such temporary differences is approximately 188,904.
5. INTANGIBLE ASSETS
Capitalized product development Acquisition Accumulated Total
value amortization
December 31, 2000 - - -
December 31, 2001 - - -
Acquisition 4,994 - 4,994
Currency translation differences 76 - 76
December 31, 2002 5,070 - 5,070
See also Note 1 Changes in Accounting Principles and Amortization and
Depreciation.
Goodwill Acquisition Accumulated Total
value amortization
December 31, 2000 57,289 -28,320 28,969
Amortization - -4,964 -4,964
Currency translation differences -1,309 893 -416
December 31, 2001 55,980 -32,391 23,589
Amortization - -4,515 -4,515
Currency translation differences -4,989 3,105 -1,884
December 31, 2002 50,991 -33,801 17,190
Goodwill relates to the acquisition made during the three-year period
between 1997 and 1999 by Biacore's Japanese subsidiary of Amersham Biosciences'
Japanese sales operation for Biacore products. It is amortized over the ten-year
period between 1997 and 2006. As the goodwill is denominated in Japanese yen,
the value in Swedish currency fluctuates with the exchange rate between the
Japanese yen and the Swedish krona.
Other intangible assets Acquisition Accumulated Total
value amortization
December 31, 2000 6,048 -2,234 3,814
Acquisition 57,511 - 57,511
Amortization - -600 -600
Currency translation differences -11 3 -8
December 31, 2001 63,548 -2,831 60,717
Acquisition 1,957 - 1,957
Reclassification 1,858 32 1,890
Disposals -19 - -19
Amortization - -1,955 -1,955
Currency translation differences -19 10 -9
December 31, 2002 67,325 -4,744 62,581
Other intangible assets mainly relate to a license acquired from Axiom
Biotechnologies in 2001 for USD 5 million which will be amortized over the
shorter of its legal life and its estimated useful life starting in 2003.
Patents acquired, which are amortized over 10 years, are also included in other
intangible assets.
6. PROPERTY, PLANT AND EQUIPMENT
Buildings Acquisition Accumulated Total
value depreciation
December 31, 2000 60,455 -7,430 53,025
Capital expenditure 8,604 - 8,604
Depreciation - -1,967 -1,967
December 31, 2001 69,059 -9,397 59,662
Capital expenditure 16,688 - 16,688
Reclassification 7,232 -829 6,403
Depreciation - -3,580 -3,580
Currency translation differences 92 -25 67
December 31, 2002 93,071 -13,831 79,240
Land and land improvements Acquisition Accumulated Total
value depreciation
December 31, 2000 7,059 -745 6,314
Depreciation - -68 -68
December 31, 2001 7,059 -813 6,246
Depreciation - -38 -38
December 31, 2002 7,059 -851 6,208
Machinery and equipment Acquisition Accumulated Total
value depreciation
December 31, 2000 86,619 -62,559 24,060
Capital expenditure 31,375 - 31,375
Reclassification -8,026 6,207 -1,819
Depreciation - -12,912 -12,912
Currency translation differences 1,739 -726 1,013
December 31, 2001 111,707 -69,990 41,717
Capital expenditure 15,076 - 15,076
Reclassification -12,851 5,152 -7,699
Depreciation - -13,655 -13,655
Currency translation differences -4,016 269 -3,747
December 31, 2002 109,916 -78,224 31,692
The tax value of real estate in Sweden as of December 31, 2002 was 32,710,
of which buildings accounted for 24,910.
7. LONG-TERM INVESTMENTS
Name Number of Owner- Acquisition Write- Book Market
shares ship, % value downs value value
Bioreason, Inc. 755,189 12.1 17,640 -17,640 - N/a
Diffchamb AB 261,816 6.9 9,750 -2,681 7,069 7,069
Sequenom, Inc. 53,538 0.1 971 -120 851 851
Total long-term investments 28,361 -20,441 7,920
Long-term investments Acquisition value Write-downs Book value
December 31, 2000 68,025 - 68,025
Divestments -27,555 - -27,555
December 31, 2001 40,470 - 40,470
Acquisitions 971 - 971
Write-downs - -28,655 -28,655
Divestments -9,185 8,214 -971
Reclassification -3,895 - -3,895
December 31, 2002 28,361 -20,441 7,920
8. LONG-TERM RECEIVABLES
As of December 31
2002 2001 2000
Long-term deferred tax assets 24,076 25,756 20,328
Other long-term receivables 3,596 2,925 2,472
Total long-term receivables 27,672 28,681 22,800
Long-term Other Total
deferred long-term
tax assets receivables
December 31, 2000 20,328 2,472 22,800
Additions 6,143 754 6,897
Deductions -430 -245 -675
Currency translation differences -285 -56 -341
December 31, 2001 25,756 2,925 28,681
Additions 4,644 1,010 5,654
Deductions -1,186 -81 -1,267
Reclassification -3,186 - -3,186
Currency translation differences -1,952 -258 -2,210
December 31, 2002 24,076 3,596 27,672
9. INVENTORIES
As of December 31
2002 2001 2000
Raw materials 18,675 4,496 8,230
Work-in-progress 2,991 10,596 1,311
Finished products 19,565 15,137 14,299
Advances to suppliers 3,260 - -
Allowance for obsolescence -1,031 -780 -688
Total inventories 43,460 29,449 23,152
Allowance for obsolescence For the years ended December 31
2002 2001 2000
Balance at beginning of period -780 -688 -595
Charged to allowance and expense -315 -2,479 -586
Write-offs and other adjustments 46 2,399 503
Currency translation differences 18 -12 -10
Balance at end of period -1,031 -780 -688
10. ACCOUNTS RECEIVABLE
Accounts receivable are presented net of allowances for doubtful accounts.
The following table summarizes the activity which has been recorded through the
allowance for doubtful accounts.
Allowance for doubtful accounts For the years ended December 31
2002 2001 2000
Balance at beginning of period -1,010 -1,768 -1,335
Charged to allowance and expense -700 -11 -487
Recovery - 728 -
Write-offs 719 187 160
Currency translation differences 169 -146 -106
Balance at end of period -822 -1,010 -1,768
11. OTHER RECEIVABLES
As of December 31
2002 2001 2000
Income tax receivables 4,484 1,388 892
Current deferred tax assets 7,401 8,751 7,093
Prepaid expenses 21,526 21,875 2,218
Other receivables 9,118 8,485 10,147
Total other receivables 42,529 40,499 20,350
At December 31, 2002, prepaid expenses included 15,204 in prepaid insurance
premiums relating to social security charges on incentive stock options.
12. MARKETABLE SECURITIES
As of December 31
2002 2001 2000
Industry commercial paper 130,913 104,151 104,694
Mortgage commercial paper 107,495 66,681 69,535
Bank deposits 35,035 14,006 -
Mortgage bond, short-term - - 22,459
Total marketable securities 273,443 184,838 196,688
All marketable securities relate to borrowers with K-1 credit rating, the
best credit rating given by Nordisk Rating for commercial paper, or with
corresponding credit rating. All marketable securities as of December 31, 2002
are denominated in SEK and mature during the first six months of the year 2003.
At December 31, 2002, the average interest rate was approximately 4%.
13. SHAREHOLDERS' EQUITY
The following table summarizes the changes in shareholders' equity for the
periods presented.
Shareholders' equity For the years ended December 31
2002 2001 2000
Balance at beginning of period 569,235 494,131 429,140
Stock options issued - 18,160 -
Currency translation differences -15,325 6,675 5,870
Net income 80,760 50,269 59,121
Balance at end of period 634,670 569,235 494,131
As of December 31, 2000, 2001 and 2002, 9,750,000 shares in Biacore
International AB with a nominal value of SEK 10 per share were issued and
outstanding. As of December 31, 2002, a further 760,000 shares, which are part
of the option program described in Note 20 and of which 696,575 were outstanding
at December 31, 2002, were authorized, making a total of 10,510,000 shares
authorized.
In order to reduce uncertainty regarding the amount of social security
taxes to be paid by Biacore relating to incentive stock options issued, 103,000
of the incentive stock options described in Note 20 have been issued to an
investment bank. The consideration for these stock options consists of an
entitlement to receive compensation from the investment bank for certain such
social security taxes and the estimated fair value of this entitlement is
charged to income over the terms of the respective stock options.
In accordance with the Swedish Companies Act, the distribution of dividends
is limited to the lesser of unrestricted shareholders' equity included in either
the Biacore Group's or Biacore International AB's balance sheet after proposed
transfers to restricted reserves.
As a result of Swedish principles for calculating restricted and
unrestricted reserves, Swedish generally accepted accounting principles state
that redistribution between restricted and unrestricted reserves should
generally not be specified.
14. PROVISION FOR PENSIONS
As of December 31
2002 2001 2000
FPG/PRI pensions 26,747 23,562 21,209
Other plans 6,600 4,188 2,962
Total provision for pensions 33,347 27,750 24,171
Biacore's pension commitments in Sweden are primarily administered through
the FPG/PRI system. Accrued pensions are discounted to present value, accrued
for and guaranteed by FPG.
PRI (Pension Registration Institute) is an organization that administers
pensions in Sweden. Biacore participates in a defined benefit pension plan
(non-contributory for employees) which covers essentially all employees in its
Swedish operation. The FPG/PRI plan forms part of a Swedish secured
multiemployer pension plan which is centrally administered. The level of
benefits and actuarial assumptions are established jointly for PRI plans, and
cannot unilaterally be changed by Biacore. A prerequisite for joining the
FPG/PRI system is that a company reports the actuarially calculated pension
obligations as a liability in its balance sheet.
FPG is an insurance company which guarantees the pensions to the
beneficiaries. FPG in turn requires a guarantee. Biacore guarantees to FPG its
own FPG/PRI pension obligations.
Certain of Biacore's businesses outside Sweden also have retirement plans.
Benefits provided under defined benefit pension plans are primarily based on
years of service and employee compensation. For international businesses with
defined benefit pension plans, Biacore determines the value of accumulated plan
benefits and records pension expense in accordance with local requirements. In
Germany and Japan, the pension liabilities are generally not funded, but are
instead reported within the provision for pensions. Biacore has no significant
defined benefit plan in the United States.
Annual pension costs for unfunded defined benefit pension plans, including
the interest portion, amounted to approximately 3,166, 3,505 and 5,961 for the
years ended December 31, 2000, 2001 and 2002, respectively. Interest expense on
the Swedish pension liability (FPG/PRI) amounted to 854, 828 and 1,585 for the
years ended December 31, 2000, 2001 and 2002, respectively, and is included in
interest expense.
The Swedish life insurance company Alecta, formerly SPP, has paid a part of
a surplus in its pension assets over its pension liabilities to its corporate
customers, and announced that such customers may use another part to cover new
pension commitments. The amounts relating to Biacore are small.
15. OTHER LIABILITIES
As of December 31
2002 2001 2000
Deferred revenue and customer advances 35,951 23,709 21,543
Payroll taxes and social security costs 12,212 16,078 14,614
Accrued vacation 9,191 7,845 6,301
Other compensation to employees 10,483 9,396 8,736
V.A.T. payable 1,019 2,316 3,727
Other 11,951 9,523 4,410
Total other liabilities 80,807 68,867 59,331
16. COMMITMENTS AND CONTINGENCIES
The contingent liability amounting to 535 at December 31, 2002, relates to
the maximum liability resulting from the limited mutual secondary liability
among FPG's customers for FPG's pension guarantees (see also Note 14).
Biacore leases certain office facilities and equipment under various
noncancelable operating lease agreements. Expenses for rented and leased assets,
including real estate, amounted to 7,033, 9,494 and 12,358 for 2000, 2001 and
2002, respectively.
Future lease commitments and rentals under noncancelable leases as of
December 31, 2002, are as follows.
Operating leases
2003 12,061
2004 9,732
2005 5,447
2006 4,569
2007 4,470
2008 and beyond 1,589
Total 37,868
17. GEOGRAPHIC INFORMATION
Biacore operates predominantly in a single industry; development,
manufacturing and marketing of bio-analytical instrumentation. It is a
multinational operation. The Swedish operation includes the parent company legal
entity, most research and development, most manufacturing and certain marketing
and administrative functions. Biacore's corporate headquarters and commercial
center, along with certain manufacturing activities, are located in Switzerland.
In the United States and Japan, Biacore has sales subsidiaries. The businesses
in France, Germany, the Netherlands, the United Kingdom, Australia and
New Zealand are sales branches.
Sales (1) Long-lived assets (2)
Year ended December 31, Year ended December 31,
2002 2001 2000 2002 2001 2000
Germany 31,504 35,439 35,303 607 505 457
Japan 144,223 122,067 96,396 23,175 28,209 33,659
Sweden 18,352 8,018 11,471 158,352 148,499 77,601
United Kingdom 48,902 44,046 39,118 1,911 464 498
United States 253,422 231,251 174,972 8,011 8,023 6,039
Other 117,751 102,896 81,560 13,521 9,156 400
Total 614,154 543,717 438,820 205,577 194,856 118,654
(1) Sales are attributed to countries based on location of customer.
(2) Total long-term assets, less long-term investments and long-term deferred
tax assets.
18. CONCENTRATIONS OF RISK
Items in the balance sheet that potentially subject Biacore to
concentration of credit risk, consist primarily of cash and bank, marketable
securities and accounts receivable.
In accordance with its treasury policy, Biacore places its cash and bank
with high credit quality institutions in order to limit the degree of credit
exposure, see Note 12 of Notes to Financial Statements. Treasury activities are
controlled based on the treasury policy and an authorization manual approved by
the Board. The policy does not limit treasury activities to any stated currency,
although at December 31, 2002, all marketable securities were denominated in
SEK.
Concentrations of credit risk with respect to accounts receivable are
limited, due to the large number of customers comprising Biacore's customer base
and their dispersion across many different geographic areas. In 2000, 2001 and
2002, no single customer accounted for 10% or more of Biacore's revenues.
Approximately 55% of Biacore's products in 2000, 2001 and 2002 were sold to
academic or government research laboratories, private research foundations and
other institutions, the funding of which may depend on grants from government
agencies. Research funding by governments is subject to significant political
risk, and government budgets for research funding may be subject to general
political trends, calling for reduced governmental expenditures. Any reduction
in governmental funding for research or any deferral of the availability of such
funding may materially affect the ability of Biacore's prospective customers to
acquire Biacore's products.
Although Biacore has operated largely on a stand-alone basis in recent
years, certain members of management were previously associated with Pfizer (or
its predecessors).
Approximately 97%, 99% and 97% of Biacore's sales in 2000, 2001 and 2002,
respectively, were derived from customers located outside Sweden and were
generally denominated in currencies other than the Swedish krona, including the
U.S. dollar, Japanese yen, British pound and the euro. Production is mainly
carried out in Sweden. Biacore has larger expenses than revenues denominated in
Swedish kronor, and more foreign currency denominated assets than liabilities.
Depreciation of the Swedish krona would tend to improve Biacore's operating
income margins while appreciation of the Swedish krona would have the opposite
effect.
The primary market risk exposure of Biacore is the exchange of foreign
sales revenues from the United States, Japan and the euro region to Swedish
kronor.
It is not possible to hedge against all currency risks to which Biacore is
exposed, and fluctuations between local currencies and the Swedish krona may
have an adverse effect on Biacore's financial condition and results of
operations.
In the normal course of business, Biacore seeks to mitigate transaction
risk by entering from time to time into forward exchange contracts through which
Biacore, in exchange for Swedish kronor, sells forward the major foreign
currencies forecast to be received by it in connection with sales outside of
Sweden. Biacore has not historically hedged against currency translation risk
(the translation of financial statements of foreign subsidiaries and branches
into Swedish kronor) and does not currently intend to do so in the future.
For a specification of forward foreign exchange contracts entered, see
Note 19.
Sweden is not among those countries whose currencies since January 1, 1999
make up the euro currency.
19. FAIR VALUE OF FINANCIAL INSTRUMENTS
The following information is presented in accordance with SFAS No. 107,
"Disclosures about Fair Value of Financial Instruments." This accounting
standard requires disclosure about estimated fair values of financial
instruments.
As of December 31
2002 2001 2000
Carrying Estimated Carrying Estimated Carrying Estimated
value fair value value fair value value fair value
Long-term
investments 7,920 7,920 40,470 39,622 68,025 65,868
Marketable
securities 273,443 273,443 184,838 184,838 196,688 196,688
Liabilities to
credit institutions 4,304 4,304 - - - -
Derivative financial instruments held or issued for purposes other than trading:
Forward foreign
exchange contracts 777 11,346 297 2,119 2,831 3,591
Hedge contract
relating to social
security costs 15,204 5,145 17,656 17,656 - -
For certain financial instruments, including accounts receivable, cash and
bank, accounts payable and other current assets and liabilities, the carrying
amounts approximate fair value because of their short maturity, low general
interest rate levels and moderate interest rate fluctuations. The fair value of
marketable securities is based on quoted market prices. The fair value of
long-term investments is based on the quoted market value where available
(Diffchamb and Sequenom). Other long-term investments, which relate to equity
instruments in a privately held company, are included in estimated fair values
at its book value of 0. Management believes that the fair value of long-term
investments is difficult to estimate but that the book values of non-listed
long-term investments approximate their fair value. The methods and assumptions
used to estimate the fair value of forward foreign exchange contracts is the
amount that Biacore would receive or pay to terminate the contracts, based upon
estimates obtained from external counterparties. The fair value of the hedge
contract against social security costs on stock options is calculated using the
Black & Scholes option pricing model.
The following table summarizes the contractual amounts and fair values of
forward foreign exchange contracts entered for purposes other than trading and
outstanding at December 31, 2000, 2001 and 2002 (contractual amounts are
translated to Swedish kronor using forward rates).
As of December 31
2002 2002 2002 2001 2001 2001 2000 2000 2000
000's Con- Con- Esti- Con- Con- Esti- Con- Con- Esti-
tractual tractual mated tractual tractual mated tractual tractual mated
amount, amount, fair amount, amount, fair amount, amount, fair
local SEK value, local SEK value, local SEK value,
currency SEK currency SEK currency SEK
USD 11,579 112,383 9,134 5,766 61,474 -357 3,424 31,826 -493
JPY 521,000 40,914 2,130 721,000 61,914 2,588 644,000 58,435 4,437
Other N/a 18,373 82 N/a 14,048 -112 N/a 8,467 -353
Total N/a 171,670 11,346 N/a 137,436 2,119 N/a 98,728 3,591
All forward exchange contracts outstanding at December 31, 2002 expire
during the year 2003.
20. PERSONNEL
For the years ended December 31
2002 2001 2000
Wages, salaries and other remuneration
Boards of Directors, Presidents and
Executive Vice Presidents (1)(2) 16,727 18,927 14,882
Other employees 158,362 137,010 97,837
Pensions and other social security
costs (3)(4) 59,016 61,509 47,127
Total 234,105 217,446 159,846
(1) Of which 3,276, 5,335 and 2,562 related to bonuses for the years 2000, 2001
and 2002, respectively.
(2) The amounts relate to officers in all group companies.
(3) Of which 14,156, 30,477 and 23,723 related to total pension expenses in
2000, 2001 and 2002, respectively.
(4) Of which 7,764, 19,354 and 8,550 related to pension expenses for Boards of
Directors, Presidents and Executive Vice Presidents in 2000, 2001 and 2002,
respectively.
For the years ended December 31
2002 2001 2000
Australia
Average number of employees 2 2 2
Of whom, women - - 1
Wages, salaries and other remuneration 1,571 789 729
France
Average number of employees 7 6 8
Of whom, women 2 2 2
Wages, salaries and other remuneration 3,467 3,915 3,833
Germany
Average number of employees 13 12 11
Of whom, women 6 4 4
Wages, salaries and other remuneration 9,388 7,226 5,607
Japan
Average number of employees 27 24 23
Of whom, women 11 7 7
Wages, salaries and other remuneration 21,508 17,320 15,616
Of which to Board of Directors,
President and Executive Vice Presidents 3,664 3,955 3,827
Of which bonuses 876 1,047 1,048
Netherlands
Average number of employees 3 4 2
Of whom, women 1 2 1
Wages, salaries and other remuneration 1,771 1,598 983
New Zealand
Average number of employees 1 1 1
Of whom, women - - -
Wages, salaries and other remuneration 2,326 1,323 813
Sweden
Average number of employees 184 165 126
Of whom, women 67 60 40
Wages, salaries and other remuneration 68,874 67,454 49,983
Of which to Boards of Directors,
President and Executive Vice Presidents 2,401 5,967 5,446
Of which bonuses -128 1,122 480
Switzerland
Average number of employees 10 3 1
Of whom, women 2 1 -
Wages, salaries and other remuneration 13,404 8,173 2,823
Of which to Board of Directors,
President and Executive Vice Presidents 8,435 5,821 2,823
Of which bonuses 1,814 2,254 1,086
United Kingdom
Average number of employees 20 12 10
Of whom, women 8 6 5
Wages, salaries and other remuneration 13,559 11,571 7,129
United States
Average number of employees 52 40 28
Of whom, women 23 15 11
Wages, salaries and other remuneration 39,221 36,568 25,203
Of which to Boards of Directors,
President and Executive Vice Presidents 2,227 3,184 2,786
Of which bonuses - 912 662
Total
Average number of employees 319 269 212
Of whom, women 120 97 71
Wages, salaries and other remuneration 175,089 155,937 112,719
Of which to Boards of Directors,
Presidents and Executive Vice Presidents 16,727 18,927 14,882
Of which bonuses 2,562 5,335 3,276
Biacore aims to provide employment terms and conditions that are
competitive within its industry. Compensation and benefits aim to reward
accountability, impact on business operations, professional qualifications,
experience, performance and achievement of financial and other business
objectives. Employment terms and conditions are also affected by regulations,
customs and other local factors.
Bonuses within Biacore are calculated based on the achievement of pre-set
financial and other business-related objectives of the Company or parts thereof.
The Annual General Meeting of Shareholders decides the remuneration of the
Board of Directors. There is no extra compensation for committee duties.
Employee Representatives do not receive Board fees. The Board of Directors
decides the compensation, benefits and other terms of employment of the
President of the Company. The Chairman of the Board and the President have
jointly decided the compensation, benefits and other terms of employment of the
Executive Vice Presidents. Effective during 2003, the Board of Directors has
decided to establish a compensation committee. Its purpose will be to prepare
items to be decided by the Board of Directors relating to compensation and
benefits to executive management. Rumuneration of the Executive Vice Presidents
will be decided by the Board of Directors.
The total remuneration to members of the Biacore Group's Boards of
Directors (other than management) amounted to 1,442, of which 1,392 related to
Biacore International AB.
Lars-Goran Andren, Chairman of the Board, received 350 as board fee. He
also received a bonus of 1,508 and certain other benefits amounting to 74, in
relation to his performance as Chief Executive Officer and Executive Chairman of
Biacore in 2001. In January 2002, Lars-Goran Andren retired from executive
duties under his defined benefit early retirement agreement.
Ulf Jonsson, President and from January 2002 also Chief Executive Officer,
received a total of 3,131 in salary and other benefits. The President was also
awarded a bonus amounting to 563 in the form of a special pension supplement.
The bonus is based on the achievement of financial and strategic objectives. The
president also received a non-recurring remuneration of 846 in relation to the
relocation of the Company's headquarters to Switzerland.
The retirement benefits of the president were up to the end of February
2002 based on a defined benefit plan with a retirement age of 60 years. With
full pension accrual he would have been entitled to a pension corresponding to
50% of his salary. As from March 2002, he is entitled to retirement benefits
under a defined contribution plan calculated on his base salary. In 2002, the
Company's contribution was 1,262. The contribution is set to correspond to a
pension of 50% of his salary assuming service until the age of 60 years. The
retirement age is 60 years.
Biacore may terminate the employment of the President on 6 months' prior
notice with severance pay equal to 24 months salary and bonus. In case of a
major change in the ownership of Biacore, where more than half of the shares are
acquired by one party, the President is entitled to severance benefits covering
24 or 30 months. The President is obligated to give 6 months prior notice of his
resignation. Upon voluntary resignation, the President is not entitled to any
severance benefit.
Biacore's two Executive Vice Presidents received aggregate salaries and
other benefits of 4,211. Bonuses during 2002 amounted to 523. These were based
on the achievement of financial and individual objectives. The Executive Vice
Presidents also received an aggregate non-recurring remuneration of 1,547 in
relation to the relocation of the Company's headquarters to Switzerland.
As from March 2002, the Executive Vice Presidents are entitled to
retirement benefits under a defined contribution plan. In 2002, the Company's
contribution was 1,209. The contribution is set to correspond to a pension of
50% of salaries assuming service until the age of 60 years. The retirement age
is 60 years.
For Executive Vice Presidents, Biacore's prior notice for terminating
employment is 6 months, with severance pay equal to 18 months salary and bonus.
In case of a major change in the ownership of Biacore, where more than half of
the shares are acquired by one party, the Executive Vice Presidents are entitled
to severance benefits covering 18 months. Executive Vice Presidents are
obligated to give 6 months prior notice of their resignation. Upon voluntary
resignation, they are not entitled to any severance benefit.
The pensions of the Chairman of the Board, the President and certain other
senior managers are secured through a pension trust. As a result of depreciation
of the market values of assets in the pension trust, Biacore has contributed
SEK 3.2 million during 2002.
To attract and retain competent and motivated employees, Biacore has
established stock-related incentive plans. The main terms of these plans are
summarized in the following table. All stock options and plan participation have
been issued free of charge to the employee except for requirements regarding
employment with Biacore. The exercise price of the stock options granted in
May 1998 is equal to 125% of the stock market price at the date of issue. For
all other stock option plans, the exercise price is equal to the stock market
price at the date of issue.
Date Expiry Type Group Source Vest- Exer- Related Of Of
of date of covered of ing cise No. which which
grant plan shares period price of out out
(1) (SEK) shares stand- stand-
ing ing
Dec. 31, Dec. 31,
2002 2001
Jan. Dec. Stock Manage- Pfizer Immedi- 75 to 119,500 - -
1997 2001 option ment ately 144
May Dec. Stock Manage- Pfizer Immedi- 88 to 117,000 2,000 5,000
1998 2007 option ment ately 105
July Dec. Stock Manage- Pfizer Immedi- 70 110,000 15,000 19,000
1999 2009 option ment ately
June Dec. Stock All N/a 1 year N/a 500 - -
1998 2000 appreci- em- per
ation ployees em-
rights (3) ployee
(2) (3)
Aug. Dec. Stock All Biacore 3 years 273 380,000 350,725 366,100
2000 2010 option em-
ployees
May May Stock Skilled Biacore 3 years 363 300,000 282,600 289,850
2001 2006 option em-
(4) ployees
May May Stock Em- Biacore 3 years 244 80,000 63,250 -
2002 2007 option ployees
in the
United
States
and newly
employed
(1) All options relate to call options.
(2) The amount was limited to 50% of the starting price of the Biacore share.
(3) Management was excluded from this program.
(4) 37,300 issued of which 24,000 outstanding options expire in May 2011 and
the remaining options in May 2006.
At the Annual General Meeting of shareholders held on May 7, 2002, it was
decided to initiate a new stock option program, the last plan in the table
above. Biacore International AB has, to its wholly owned subsidiary Biacore
Administration AB, issued one subordinated note for the amount of SEK 1,000 with
80,000 attached warrants for subscription to new shares in Biacore
International AB. Biacore Administration AB has issued corresponding options to
employer companies within Biacore, which in turn have issued options to
employees free of charge. The plan is mainly directed to employees in the United
States and newly employed personnel. The allotment to each employee is allowed
to vary between 500 and 2,000. The exercise price is SEK 244 and corresponds to
the stock market price at the time of issuance. The employee stock options
expire in May 2007 and vest to each employee over a period starting one year and
ending three years after issuance of the options.
All reductions in the number of outstanding stock options granted by
Biacore are due to resignations which have caused the stock options of those
employees to lapse. For stock options to Biacore shares granted by Pfizer
(Pharmacia), the reductions are due to disposals by the employees. In May 2002,
65,750 stock options were granted, of which 2,500 have lapsed due to
resignations. In total, there are 287,712 (74,925) stock options outstanding
which have vested with employees.
The following table shows a breakdown of the total number of stock options
for ordinary shares in Biacore granted to senior management during the
three-year period from 2000 to 2002. No stock option was granted so senior
management in 2002.
Issued to Year Number Expiration date Exercise price (SEK)
Chairman of the Board 2000 25,000 Dec. 15, 2010 273.00
2001 22,000 May 31, 2011 363.00
President 2000 15,000 Dec. 15, 2010 273.00
2001 18,000 May 31, 2006 363.00
Others 2000 20,000 Dec. 15, 2010 273.00
2001 20,000 May 31, 2006 363.00
21. SUPPLEMENTAL FINANCIAL INFORMATION
Biacore does not own any share of XenoSense Ltd, but does hold convertible
loans acquired in 2000 and 2002 which, since the first quarter of 2002, upon a
future conversion, would give Biacore an ownership of 84%. There are also
agreements which give Biacore significant influence over XenoSense. As from
January 1, 2002, XenoSense is therefore consolidated as a subsidiary to Biacore.
Its activities, earnings, assets and liabilities are very limited compared with
Biacore as a whole.
Acquisition of XenoSense For the years ended December 31
2002 2001 2000
Fair value of assets acquired, excluding cash - - -
Liabilities assumed and incurred - - -
Total cash paid for net assets acquired 4,048 - 3,895
Cash acquired 9,537 - -
Minority interest 1,594 - -
Cash paid for interest and income taxes was as follows:
For the years ended December 31
2002 2001 2000
Interest 248 227 180
Income taxes 29,135 32,871 30,086
Audit expenses amount to 1,656 (1,071) and the expense for other services
supplied by the auditors has been 1,529 (811), 3,185 (1,882) in total. All
expenses relate to PricewaterhouseCoopers, except for 145 (159) in audit
expenses which relate to Sojiro Takagaki.
22. SUBSEQUENT EVENTS
Biacore's sales fell by 25% in the first quarter of 2003 to
SEK 106.5 million compared with SEK 141.3 million in the first quarter of 2002.
Diluted earnings per share fell by 65% from SEK 2.17 in the first quarter of
2002 to SEK 0.77 in the first quarter of 2003. (Unaudited).
On May 8, 2003, the Annual General Meeting of Shareholders adopted the
recommendation of the Board of Directors that Biacore pay a dividend of SEK 3.00
per share for 2002. The dividend was paid on May 16, 2003. (Unaudited).
The May 8, 2003 Annual General Meeting of Shareholders also approved an
employee stock option plan covering a maximum of 100,000 new shares with an
exercise price of SEK 178 per share, the stock market price at the time of grant
of the stock options. The stock options expire in May 2008. Except for employees
of Biacore, none of these stock options may be granted to Directors of the Board
of Directors of Biacore. A maximum of 10,000 stock options may be granted to the
Chief Executive Officer / President of Biacore, 5,000 per person to others in
senior management, 2,000 to other key employees and 500 to other employees. The
Board will decide on the allotment in each individual case. No allotment is
guaranteed. The stock options will be distributed free of charge to the
employee, except for certain conditions regarding employment. (Unaudited).
23. GENERALLY ACCEPTED ACCOUNTING PRINCIPLES IN THE UNITED STATES (U.S. GAAP)
The financial statements have been prepared in accordance with Swedish
GAAP. These accounting principles differ in certain respects from U.S. GAAP.
Following is a summary of the adjustments from Swedish GAAP to U.S. GAAP
that affect Biacore's net income and comprehensive income for the years ended
December 31, 2000, 2001 and 2002, and total shareholders' equity and accumulated
other comprehensive income as of December 31, 2000, 2001 and 2002, respectively,
together with a discussion of the principal differences between Swedish and U.S.
GAAP that are significant to Biacore's financial statements.
For the years ended December 31
2002 2002 2001 2000
USD (1) SEK SEK SEK
(unaudited)
Net income in accordance with Swedish GAAP 9,288 80,760 50,269 59,121
Adjustments:
Capitalized product development -583 -5,070 - -
Contract with Amersham Biosciences 519 4,515 4,964 4,956
Revenue recognition - - - 13,712
Foreign exchange contracts 1,006 8,747 1,062 4,087
Pensions 84 734 526 -383
Social security costs on stock options,
accrued expense -227 -1,974 -16 1,990
Social security costs on stock options,
insurance claim 227 1,974 -1,974 -
Social security costs on stock options,
insurance contract -1,157 -10,059 - -
Definition of subsidiary 192 1,666 -1,666 -
Deferred taxes on U.S. GAAP adjustments -764 -6,649 -1,903 -8,459
Net income in accordance with U.S. GAAP 8,585 74,644 51,262 75,024
Other comprehensive income
Long-term investments, unrealized
gains (losses) 97 848 1,309 -785
Currency translation differences -1,654 -14,383 6,883 5,867
Other comprehensive income, before tax -1,557 -13,535 8,192 5,082
Income tax expense related to long-term
investments -27 -237 -367 220
Other comprehensive income -1,584 -13,772 7,825 5,302
Comprehensive income in accordance with
U.S. GAAP 7,001 60,872 59,087 80,326
Basic earnings per share in accordance
with U.S. GAAP 0.88 7.66 5.26 7.69
Diluted earnings per share in accordance
with U.S. GAAP 0.88 7.66 5.23 7.67
Weighed average No. of shares, U.S. GAAP,
diluted (thousands) 9,750 9,750 9,805 9,780
(1) Solely for the convenience of the reader, 2002 financial information has
been translated to USD thousands (USD as regards per share data) using the
December 31, 2002 Noon Buying Rate of USD 1 = SEK 8.6950.
As of December 31
2002 2002 2001 2000
USD (1) SEK SEK SEK
(unaudited)
Shareholders' equity in accordance with
Swedish GAAP 72,993 634,670 569,235 494,131
Adjustments
Capitalized product development -583 -5,070 - -
Contract with Amersham Biosciences -1,977 -17,190 -23,589 -28,969
Long-term investments - - -848 -2,157
Foreign exchange contracts 1,216 10,569 1,822 760
Pensions -30 -259 -993 -1,519
Social security costs on stock options,
accrued expense - - 1,974 1,990
Social security costs on stock options,
insurance claim - - -1,974 -
Social security costs on stock options,
insurance contract -1,157 -10,059 - -
Definition of subsidiary - - -1,666 -
Deferred taxes on U.S. GAAP adjustments 510 4,438 12,266 14,744
Shareholders' equity in accordance with
U.S. GAAP 70,972 617,099 556,227 478,980
Accumulated other comprehensive income
Long-term investments, unrealized
gains (losses) - - -848 -2,157
Currency translation differences 1,731 15,050 29,433 22,550
Accumulated other comprehensive income,
before tax 1,731 15,050 28,585 20,393
Income tax expense related to long-term
investments - - 237 604
Accumulated other comprehensive income in
accordance with U.S. GAAP 1,731 15,050 28,822 20,997
(1) Solely for the convenience of the reader, 2002 financial information has
been translated to USD thousands (USD as regards per share data) using the
December 31, 2002 Noon Buying Rate of USD 1 = SEK 8.6950.
Comprehensive Income
SFAS No. 130, "Reporting Comprehensive Income," establishes standards for
the reporting and presentation of comprehensive income and its components.
Comprehensive income generally encompasses all changes in shareholders' equity
from transactions and events from nonowner sources.
Capitalized Product Development
As from 2002 and in accordance with Swedish GAAP, certain product
development expenses are capitalized and amortized over their individually
estimated useful lives, starting when the respective products are ready for
first delivery, see Notes 1 and 5.
Under U.S. GAAP, all research and development expenses are charged to
earnings as incurred.
Contract with Amersham Biosciences
Under Swedish GAAP, a contract with Amersham Biosciences has been accounted
for as the acquisition of a business which resulted in the recognition of
goodwill. This goodwill is being amortized over a period of ten years starting
January 1, 1997.
Under U.S. GAAP, the contract with Amersham Biosciences has been accounted
for as purchase of services rendered during a three-year period starting
January 1, 1997. Accordingly, the costs of the services purchased have been
charged to income as marketing expenses in the period the services were
rendered.
Revenue Recognition
Under Swedish GAAP, sales are recognized when no significant vendor
obligation remains and collection of the resulting receivable is probable.
Under U.S. GAAP, Biacore adopted the American Institute of Certified Public
Accountants' Statement of Position ("SOP") 97-2 "Software Revenue Recognition"
during the year ended December 31, 1998. When a software arrangement includes
more than one element, SOP 97-2 requires that revenue be allocated to all
elements based on fair value. If the fair value of all elements is not
available, deferral of all revenue is required. Certain of Biacore's sales
arrangements include additional services, for which fair value has not
objectively been established. Under U.S. GAAP, Biacore therefore defers
recognition of the revenue on such arrangements until the additional services
are provided to the customers. At December 31, 2000, 2001 and 2002, there were
no such unperformed services.
Long-term Investments
In accordance with Swedish GAAP, long-term investments are carried at cost
less write-downs recorded when impairment in value is other than temporary.
According to U.S. GAAP, these equity securities qualify as "available for
sale" and are carried at fair value. The unrealized gains and losses, net of
deferred taxes, are classified as a separate component of shareholders' equity
until realized.
Foreign Exchange Contracts
SFAS 133 "Accounting for Derivative Instruments and Hedging Activities"
establishes accounting and reporting standards for derivative instruments and
hedging activities. In general, SFAS 133 requires that companies recognize all
derivatives as either assets or liabilities on the balance sheet and measure
those instruments at fair value. Biacore uses derivative instruments to manage
the risk of fluctuations in foreign currencies. The Company adopted SFAS 133 for
U.S. reporting purposes on January 1, 2001.
Under both Swedish GAAP and U.S. GAAP, unrealized gains and losses are
recorded on forward contracts from the date such contracts are entered. To the
extent such contracts qualify as cash flow hedges of forecasted transactions,
unrealized gains and losses are deferred until the transaction being hedged is
recorded.
The criteria applied under U.S. GAAP for determining which transactions
qualify as cash flow hedges are different from those applied under Swedish GAAP
and have not been fulfilled as regards the forward contracts entered into by
Biacore to hedge cash flow from forecasted sales. Accordingly, under U.S. GAAP,
unrealized gains and losses on such forward foreign exchange contracts are
included in net income.
Pensions
Under Swedish GAAP, Biacore provides for its pension obligations based on
actuarial calculations. Under U.S. GAAP, the determination of pension costs and
obligations is also based on actuarial assumptions, but the methods and
assumptions are different under SFAS No. 87, "Employers' Accounting for
Pensions."
Some of the pension plans are unfunded. However, provisions for pensions
are recorded. A summary of the funded status of Biacore's significant defined
benefit pension plans in accordance with SFAS No. 87 and SFAS No. 132
"Employers' Disclosures about Pensions and Other Postretirement Benefits"
follows.
As of December 31
2002 2001 2000
Accumulated vested benefit obligations 24,554 21,456 19,426
Projected benefit obligation 30,535 24,947 21,776
Plan assets at fair value - - -
Projected benefit obligation in excess of plan assets 30,535 24,947 21,776
Unrecognized prior service cost 4,811 3,232 3,372
Unrecognized actuarial gain (loss) -8,241 -3,516 -2,304
Unrecognized transition obligation -99 -108 -116
Liability for FPG/PRI pensions 27,006 24,555 22,728
Liability for other plans 6,600 4,188 2,962
Total liability 33,606 28,743 25,690
The changes in the projected benefit obligation in accordance with U.S.
GAAP have been caused by the following factors.
For the years ended December 31
2002 2001 2000
Projected benefit obligation at beginning of the year 24,947 21,776 20,408
Service cost 1,138 752 1,166
Interest cost 1,372 1,198 1,123
Plan amendment -1,720 - -
Actuarial losses (gains) 4,798 1,221 -921
Benefits paid - - -
Projected benefit obligation at end of year 30,535 24,947 21,776
Pension cost calculated in accordance with U.S. GAAP includes the
following.
For the years ended December 31
2002 2001 2000
Service cost benefits earned during the year 1,138 752 1,166
Interest cost on projected benefit obligation 1,372 1,198 1,123
Amortization of unrecognized prior service cost -141 -140 -141
Amortization of actuarial loss 73 9 41
Amortization of remaining transition obligation 9 8 8
Net pension cost for FPG/PRI pensions 2,451 1,827 2,197
Net pension cost for other defined benefit plans 2,776 1,152 1,352
Total pension cost for defined benefit plans 5,227 2,979 3,549
Assumptions used for the defined benefit plans were:
% For the years ended December 31
2002 2001 2000
Weighted average discount rate 5.50 5.50 5.50
Rates of increase in compensation levels 3.25 3.25 3.00
Inflation rate 2.00 2.00 2.00
Biacore has not yet paid any significant contribution regarding these
defined benefit plans.
Social Security Costs on Stock Options
In accordance with Swedish GAAP, Biacore accrues for social security costs
payable on future exercise of stock options and amortizes prepaid insurance
premiums against social security expenses over the terms of the respective stock
options.
According to U.S. GAAP, social security costs payable on future exercise of
stock options are recorded when the event that triggers the measurement and
payment of the tax to the taxing authority occurs.
In Swedish GAAP for the year 2000, Biacore accrued for social security
costs payable on future exercise of stock options, expenses which in accordance
with the above were not recorded according to U.S. GAAP. In 2001, Biacore
purchased an insurance policy against such social security costs.
Hedge on Social Security Costs of Stock Options
In order to reduce uncertainty regarding the amount of social security
taxes to be paid by Biacore relating to incentive stock options issued, 103,000
of the incentive stock options described in Note 20 have been issued to an
investment bank. The consideration for these stock options consists of an
entitlement to receive compensation from the investment bank for certain such
social security taxes and the estimated fair value of this entitlement is
charged to income over the terms of the respective stock options.
Under U.S. GAAP, in accordance with Emerging Issues Task Force No. 00-19,
"Accounting for Derivative Financial Instruments Indexed to, and Potentially
Settled in, a Company's Own Stock," the payment for the insurance instrument is
considered a derivative asset. The notional amount and fair value of the
derivative asset at December 31, 2002 were 500 and 5,145, respectively.
Reimbursement received from the investment bank for social security taxes
reduces the value of the derivative asset. The fair value of the derivative
asset is evaluated at the end of each year and the unrealized gains/losses are
recorded in the income statement.
Definition of Subsidiary
In accordance with Swedish GAAP, the consolidated financial statements
include entities in which Biacore International AB, directly or indirectly,
holds more than 50% of the voting rights.
According to U.S. GAAP, entities shall generally be consolidated based upon
the criteria of control.
In 2000, Biacore lent GBP 275 thousand to XenoSense Ltd. In 2002, a further
GBP 275 thousand was lent. These loans can be converted to shares in XenoSense.
After such conversion, Biacore would own approximately 84% of XenoSense. Through
an agreement, Biacore also has certain possibilities to influence XenoSense.
Accordingly, under U.S. GAAP, XenoSense is consolidated as a subsidiary to
Biacore already in 2001.
Marketable Securities
Marketable securities consist of industry and mortgage commercial paper,
short-term bank deposits and short-term mortgage bonds. Under Swedish GAAP,
interest on these securities is recognized ratably from acquisition until
maturity or sale.
Under U.S. GAAP, these assets qualify as "available for sale" and should
be carried at fair value. Unrealized gains and losses, net of deferred taxes,
should be classified as a separate component of shareholders' equity until
realized.
Deferred Taxes
Deferred taxes are calculated on the U.S. GAAP adjustments described above
in accordance with SFAS No. 109, "Accounting for Income Taxes," where
appropriate.
Deferred taxes are also adjusted for a difference between Swedish and U.S.
GAAP relating to intercompany profits. Under Swedish GAAP, deferred taxes from
elimination of intercompany profits are calculated using the enacted tax rate of
the purchaser. Under U.S. GAAP, the deferred tax is calculated using the tax
rate of the seller.
Diluted Earnings Per Share
The basic methodology for calculating diluted earnings per share ("EPS")
under U.S. GAAP is consistent with Swedish GAAP. The diluted EPS calculation
assumes that proceeds from a hypothetical exercise of options and warrants are
used to re-purchase shares. The incremental shares, calculated as the difference
between the number of shares assumed issued and the number of shares assumed
purchased, are included in the denominator of the diluted EPS computation. The
number of shares assumed purchased is determined by dividing the assumed
proceeds from exercise by the average market price during the period. However,
there is a difference in application. Swedish GAAP requires that the assumed
proceeds be discounted. Under U.S. GAAP, the assumed proceeds are not
discounted.
Classifications
Interest expense associated with the Swedish pension liability that is
included in interest expense under Swedish GAAP in the amounts of 854, 828 and
1,585 for the years ended December 31, 2000, 2001 and 2002, respectively, would
be included in operating expenses under U.S. GAAP.
The accompanying statements of cash flows are prepared in a format
consistent with SFAS No. 95 "Statement of Cash Flows," except for the
presentation of marketable securities as liquid funds. Under SFAS No. 95, cash
and cash equivalents presented should generally only include items with original
maturities of three months or less. Under Swedish GAAP, marketable securities
which would not meet the definition of cash and cash equivalents in accordance
with SFAS No. 95, have been presented with cash and bank as liquid funds in the
statements of cash flows. As a result, changes in the portion of liquid funds
not meeting the U.S. GAAP definition of cash and cash equivalents would be
classified as investing activities under SFAS No. 95. These differences between
Swedish and U.S. GAAP are indicated in the following table.
For the years ended December 31
2002 2001 2000
Balance sheets
Swedish GAAP
Marketable securities 273,443 184,838 196,688
Cash and bank 78,146 35,970 71,065
Liquid funds 351,589 220,808 267,753
U.S. GAAP
Investments in marketable securities 168,802 129,941 121,999
Cash and cash equivalents 182,787 90,867 145,754
Liquid funds 351,589 220,808 267,753
Statements of cash flows
Net increase (decrease) in liquid funds
(Swedish GAAP) 130,781 -46,945 26,075
Adjustments
Cash flows from operating activities
Deduction of interest on marketable securities -4,955 -6,347 -5,798
Cash flows from investing activities
Purchase of marketable securities -335,897 -414,440 -367,468
Sales and maturities of marketable securities 301,991 412,845 438,356
Net increase (decrease) in cash and
cash equivalents (U.S. GAAP) 91,920 -54,887 91,165
Effect of Recent Pronouncements
In June 2001, the U.S. Financial Accounting Standards Board issued
SFAS No. 143, "Accounting for Asset Retirement Obligations." SFAS No. 143
addresses financial accounting and reporting for obligations associated with the
retirement of tangible long-lived assets and the associated asset retirement
costs. It is effective for financial statements issued for financial years
beginning after June 15, 2002. Biacore is adopting this accounting standard as
from its financial year 2003. Management does not expect the impact of the
adoption of SFAS No. 143 to be material to Biacore's financial statements.
In June 2002, the U.S. Financial Accounting Standards Board issued
SFAS No. 146, "Accounting for Costs Associated with Exit or Disposal
Activities." SFAS No. 146 changes the time of recognition and measurement
principle for costs associated with exit or disposal activities to the time a
liability is incurred instead of an entity's commitment to a plan and to
measurement based on the fair values of liabilities. It is effective for exit or
disposal activities initiated after December 31, 2002. Biacore is adopting this
accounting standard as from January 1, 2003. Management does not expect the
impact of the adoption of SFAS No. 146 to be material to Biacore's financial
statements.
In November 2002, the FASB issued FASB Interpretation No. 45 ("FIN 45"),
"Guarantor's Accounting and Disclosure Requirements for Guarantees, Including
Indirect Guarantees of Indebtedness of Others." FIN 45 requires a liability to
be recognized at the time a company issues a guarantee for the fair value of the
obligations assumed under certain guarantee agreements. The provisions for
initial recognition and measurement of guarantee agreements are effective on a
prospective basis for guarantees that are issued or modified after December 31,
2002. Management does not expect the impact of the adoption of FIN 45 to be
material to Biacore's financial statements.
In December 2002, the U.S. Financial Accounting Standards Board issued
SFAS No. 148, "Accounting for Stock-Based Compensation - Transition and
Disclosure." SFAS No. 148 changes the transition rules which apply in case
companies start to recognize grants of incentive stock options as remuneration
to be charged to expenses in the income statement. It is effective for financial
years ending after December 15, 2002 and interim periods beginning after
December 15, 2002, but does not require that incentive stock options be charged
to expenses. Biacore is adopting this accounting standard as from the applicable
dates. The adoption of SFAS No. 148 has not been and is not expected to be
material to Biacore's financial statements. However, if incentive stock options
would be stated as expenses in the income statement, then such a change of
accounting principles could be material to Biacore's financial statements,
mainly by reducing net income and earnings per share and increasing other
shareholders' equity.
In January 2003, the FASB issued FASB Interpretation No. 46 ("FIN 46"),
"Consolidation of Variable Interest Entities - an interpretation of ARB No. 51."
FIN 46 addresses consolidation by business enterprises of variable interest
entities (previously often referred to as special-purpose entities, SPEs). It
requires existing unconsolidated variable interest entities to be consolidated
by their primary beneficiaries if the entities do not effectively disperse risks
among parties involved. Variable interest entities that effectively disperse
risks will not be consolidated unless a single party holds an interest or
combination of interests that effectively recombines risks that were previously
dispersed. The primary beneficiary of a variable interest entity is the party
that absorbs a majority of the entity's expected losses, receives a majority of
its expected residual returns, or both, as a result of holding variable
interests, which are the ownership, contractual, or other pecuniary interests in
an entity. The ability to make decisions is not a variable interest, but it is
an indication that the decision maker should carefully consider whether it holds
sufficient variable interests to be the primary beneficiary. An enterprise with
a variable interest in a variable interest entity must consider variable
interests of related parties and de facto agents as its own in determining
whether it is the primary beneficiary of the entity. FIN 46 applies immediately
to variable interest entities created after January 31, 2003, and to variable
interest entities in which an enterprise obtains an interest after that date. It
applies in the first fiscal year or interim period beginning after June 15,
2003, to variable interest entities in which an enterprise holds a variable
interest that it acquired before February 1, 2003. Management does not expect
the impact of the adoption of FIN 46 to be material to Biacore's financial
statements.
Item 18. FINANCIAL STATEMENTS
See Item 17.
Item 19. EXHIBITS
Document Reference
1. Articles of Association of Exhibit to Form 20-F for the
Biacore International Aktiebolag (1) year ended December 31, 1999
4a. Biacore Stock Option Plan 2000 (1) Form S-8 filed during 2000
4b. Biacore Stock Option Plan 2001 (1) Form S-8 filed during 2001
4c. Biacore Stock Option Plan 2002 (1) Form S-8 filed during 2002
6. Earnings Per Share
8. Subsidiaries See Item 4C herein
10. Consent of Auditors
(1) These documents are incorporated by reference to documents previously
filed with the SEC.
SIGNATURES
The registrant hereby certifies that it meets all of the requirements for
filing on Form 20-F and that it has duly caused and authorized the undersigned
to sign this annual report on its behalf.
Date June 16, 2003
Biacore International AB (publ)
/s/ Ulf Jonsson
Name Ulf Jonsson
Title President and Chief Executive Officer
CERTIFICATIONS
I, Ulf Jonsson, certify that:
1. I have reviewed this annual report on Form 20-F of Biacore International AB
(publ);
2. Based on my knowledge, this annual report does not contain any untrue
statement of a material fact or omit to state a material fact necessary to
make the statements made, in light of the circumstances under which such
statements were made, not misleading with respect to the period covered by
this annual report;
3. Based on my knowledge, the financial statements, and other financial
information included in this annual report, fairly present in all material
respects the financial condition, results of operations and cash flows of the
registrant as of, and for, the periods presented in this annual report;
4. The registrant's other certifying officers and I are responsible for
establishing and maintaining disclosure controls and procedures (as defined
in Exchange Act Rules 13a-14 and 15d-14) for the registrant and have:
a. designed such disclosure controls and procedures to ensure that material
information relating to the registrant, including its consolidated
subsidiaries, is made known to us by others within those entities,
particularly during the period in which this annual report is being
prepared;
b. evaluated the effectiveness of the registrant's disclosure controls and
procedures as of a date within 90 days prior to the filing date of this
annual report (the "Evaluation Date"); and
c. presented in this annual report our conclusions about the effectiveness of
the disclosure controls and procedures based on our evaluation as of the
Evaluation Date;
5. The registrant's other certifying officers and I have disclosed, based on our
most recent evaluation, to the registrant's auditors and the audit committee
of registrant's board of directors (or persons performing the equivalent
function):
a. all significant deficiencies in the design or operation of internal
controls which could adversely affect the registrant's ability to record,
process, summarize and report financial data and have identified for the
registrant's auditors any material weaknesses in internal controls; and
b. any fraud, whether or not material, that involves management or other
employees who have a significant role in the registrant's internal
controls; and
6. The registrant's other certifying officers and I have indicated in this
annual report whether or not there were significant changes in internal
controls or in other factors that could significantly affect internal
controls subsequent to the date of our most recent evaluation, including any
corrective actions with regard to significant deficiencies and material
weaknesses.
Date June 16, 2003
/s/ Ulf Jonsson
Name Ulf Jonsson
Title President and Chief Executive Officer
I, Lars-Olov Forslund, certify that:
1. I have reviewed this annual report on Form 20-F of Biacore International AB
(publ);
2. Based on my knowledge, this annual report does not contain any untrue
statement of a material fact or omit to state a material fact necessary to
make the statements made, in light of the circumstances under which such
statements were made, not misleading with respect to the period covered by
this annual report;
3. Based on my knowledge, the financial statements, and other financial
information included in this annual report, fairly present in all material
respects the financial condition, results of operations and cash flows of the
registrant as of, and for, the periods presented in this annual report;
4. The registrant's other certifying officers and I are responsible for
establishing and maintaining disclosure controls and procedures (as defined
in Exchange Act Rules 13a-14 and 15d-14) for the registrant and have:
a. designed such disclosure controls and procedures to ensure that material
information relating to the registrant, including its consolidated
subsidiaries, is made known to us by others within those entities,
particularly during the period in which this annual report is being
prepared;
b. evaluated the effectiveness of the registrant's disclosure controls and
procedures as of a date within 90 days prior to the filing date of this
annual report (the "Evaluation Date"); and
c. presented in this annual report our conclusions about the effectiveness of
the disclosure controls and procedures based on our evaluation as of the
Evaluation Date;
5. The registrant's other certifying officers and I have disclosed, based on our
most recent evaluation, to the registrant's auditors and the audit committee
of registrant's board of directors (or persons performing the equivalent
function):
a. all significant deficiencies in the design or operation of internal
controls which could adversely affect the registrant's ability to record,
process, summarize and report financial data and have identified for the
registrant's auditors any material weaknesses in internal controls; and
b. any fraud, whether or not material, that involves management or other
employees who have a significant role in the registrant's internal
controls; and
6. The registrant's other certifying officers and I have indicated in this
annual report whether or not there were significant changes in internal
controls or in other factors that could significantly affect internal
controls subsequent to the date of our most recent evaluation, including any
corrective actions with regard to significant deficiencies and material
weaknesses.
Date June 16, 2003
/s/ Lars-Olov Forslund
Name Lars-Olov Forslund
Title Executive Vice President and Chief Financial Officer