FINANCIAL STATEMENT BULLETIN OF BIOHIT 1
BIOHIT PLC. STOCK EXCHANGE RELEASE 15.2.2002 AT 10:00
FINANCIAL STATEMENT BULLETIN OF BIOHIT 1.1. - 31.12.2001
The net sales of the Biohit Group increased by 5% in 2001 and totalled
MEUR 25.5. During the financial year Biohit continued investing
strongly in research and development and in increasing production
capacity. The Group operating profit totalled MEUR 0.2 and the loss
for the year MEUR 0.2. The net cash flow from operating activities was
MEUR 1.8 positive.
Net Sales
The net sales of the Biohit Group increased by 5% in 2001 and totalled
MEUR 25.5 (MEUR 24.2). If the effect of Wolf Laboratories Ltd., the
company having specialized in commission business in the U.K. and
which was sold at the end of 2000, is eliminated from the net sales of
2000, the growth of the Group net sales in 2001 is over 20%. The net
sales continued to be generated primarily by the sales of liquid
handling products and disposables.
Deviating from preliminary estimates, the significant investments made
in 2001 and previous years in the research and development and
establishment of a global co-operation and customer service network
did not for the part of the diagnostic products generate a significant
increase in the net sales for 2001. Although the market potential for
Biohit's finished diagnostic product is great, gaining optimal benefit
of this potential is time-consuming due to numerous evaluations and
approvals by authorities which need to be obtained. In 2001 the
investments made in the evaluations and marketing of the diagnostic
products were covered by the profitable sales of liquid handling
products.
The share of exports of Group net sales continued to be 96%. 51% of
the net sales were generated in European countries, 25% in North
America and the remaining 24% primarily in Asia.
Profit/Loss
The Group operating profit totalled MEUR 0.2 (Group operating loss
MEUR 0.5 in 2000). Profit before group goodwill depreciation totalled
MEUR 1.2 (MEUR 0.5).
The Group fixed costs increased approx. 17% which was primarily due to
investments in the international sales organization and the research,
development and production of the diagnostic tests. Also the numerous
evaluations and marketing of diagnostics had an effect on the fixed
costs.
The net financial expenses totalled MEUR 0.2 (MEUR 0.1).
The profit before extraordinary items was MEUR 0.1 (MEUR 0.6 loss) and
the loss for the period MEUR 0.2 (MEUR 0.6 loss).
Earnings per share were EUR -0.02 (EUR -0.06).
Balance Sheet
The business operations of Locus genex Oy, the subsidiary company
specializing in diagnostic products, were transferred to Biohit Plc.
on May 1, 2001. It has been calculated that the dissolution has a
positive corporate tax impact of MEUR 0.7 on the Group, which is
deferred in the consolidated financial statements over the remaining
amortization period of 5 years of the goodwill relating to Locus
genex. With regard to the dissolution of Locus genex Oy, the balance
sheet of December 31, 2001 includes a tax liability of MEUR 1.2 under
short-term liabilities and a deferred tax receivable of MEUR 1.2 under
receivables.
Liquidity
The liquidity of the Biohit Group is good. The net cash flow provided
by operating activities was MEUR 1.8 positive (MEUR 0.9).
The gearing ratio was 65.7% on December 31, 2001 (66.9%).
Investments
The gross investments totalled MEUR 2.1 (MEUR 7.1). The clean room
unit enabling the mass production of diagnostic tests together with
related equipment as well as machinery and equipment intended for
increasing other production capacity constituted the major part of the
investments.
The Group research and development expenditure totalled MEUR 2.1 (MEUR
1.7), i.e., 8.3% (7.0%) of the net sales.
Main Events of the Reporting Period
Liquid Handling
In the area of liquid handling Biohit continued to develop new
pipettor generations. This development work is based on Biohit's
liquid handling product strategy in which new market segments have
been identified and created. These segments differ from each other in
terms of the area of application, performance and price.
In its development of liquid handling products Biohit has paid special
attention to the safety and ergonomic aspects of pipettors, which
contribute, e.g., to reducing the risk of work-related upper limb
disorders.
In 2001 Biohit launched the single-channel models of the eLINE-range,
a new generation of electronic pipettors. The multichannel models will
be launched in 2002. The eLINE received an honorary mention on Feb. 1,
2001 in the Pro Finnish Design 2001 -competition arranged by Design
Forum Finland.
The eLINE electronic pipettors offer the latest technology in the
field of hand-held liquid handling devices. The range was designed to
meet the most demanding pipetting applications offering, thus, e.g.,
eleven liquid handling protocols for the various needs of today's
laboratories. The microprocessor-controlled system and the novel
construction of the eLINE-pipettors enable maximum liquid handling
performance with high levels of accuracy and precision. The ergonomic
design of the eLINE together with unique electronic tip ejection are
examples of Biohit's continuous efforts to improve further the
ergonomy and competitiveness of pipetting.
In the area of electronic liquid handling Biohit continued the
development of OEM-products, which complement the product ranges and
diagnostic systems of other companies. For example, Biohit developed
for a Swiss company an application which is based on the eLINE
concept. The application is connected to an instrument, and the system
is used for measuring the factors affecting blood coagulation in
operating rooms.
Diagnostics
The evaluations of the test panel for determining H. pylori -infection
and atrophic gastritis and for screening the risk of gastric cancer
and peptic ulcer from blood samples continued according to plans.
Evaluations were carried out in Finland and on the most important
market areas abroad by over twenty research and scientist groups. The
results of the evaluations completed in 2001 were positive and
supported the results of those completed previously.
The new production premises for diagnostic tests were completed and
taken into use in Helsinki in 2001. The premises enable to enter from
the pilot production of diagnostic tests to their mass production. All
Biohit's diagnostic tests will be manufactured in the premises.
In March the ISO 9001 -quality system certification of Biohit Oyj was
extended to cover also the area of diagnostics as a result of the
audit conducted by Det Norske Veritas. In fall the certification was
further extended, and currently the business area of diagnostics
conforms also with the requirements set by the ISO 13485 -standard on
quality systems. Moreover, the diagnostic products were registered to
the National Agency for Medicines in Finland. As a result all Biohit's
products can be labelled with the CE-mark and can, thus, be sold in
Europe for both diagnostic and research use.
In 2001 the marketing of the GastroPanel began for research use
worldwide. In Canada authorities issued product licenses for the
Pepsinogen I, Gastrin-17 and Helicobacter pylori -test kits of the
GastroPanel. This enables Biohit to commence the marketing and sales
of the GastroPanel also for clinical use in Canada. In 2001 the
service laboratories United Clinical Laboratories and VITA-
Terveyspalvelut Oy commenced the marketing of the test panel for
their clientele in Finland.
In the U.K. Immunology Quality Services evaluated with favourable
results Biohit's anti-dsDNA ELISA -test kit for the diagnosis of
systemic lupus erythematosus (SLE). The evaluation demonstrated that
the sensitivity, specificity and precision of the test are good.
The European Commission granted Biohit an approx. MEUR 0.2 support for
the development of monoclonal antibodies and test kits for
phytoestrogens. The development work commenced in May 2001 and it will
last until April 2004. The work is part of a Europe-wide project, the
purpose of which is to study the role of dietary phytoestrogens in the
prevention of certain types of cancer.
In order to enhance the evaluation and adoption of its diagnostic test
systems Biohit commenced to offer laboratory services targeted to
researchers and the health care sector. The State Provincial Office of
Southern Finland, Department for Social and Health Affairs, granted an
authorization for the service laboratory on May 8, 2001. The service
laboratory collects patient samples, e.g., from health care centers,
occupational health service centers, other medical centers as well as
regional and central hospitals. The laboratory analyses conducted aim
to support basic research and promote correct diagnoses and related
treatment (evidence-based medicine).
Development of the Price of Biohit's B-Share
In 2001 the turnover of Biohit's B-share at the Helsinki Exchanges was
EUR 4,863,535.92 and 908,660 in pieces. The highest price was EUR
7.20, the lowest EUR 3.00 and the average price EUR 5.35. The closing
price at the end of 2001 was EUR 4.28.
Administration and Personnel
During the financial year the following persons have been members of
the Board of Directors of Biohit Plc. Professor Reijo Luostarinen as
the Chairman, and docent Arto Alanko, Osmo Suovaniemi, M.D., Ph.D. and
Professor Mårten Wikström as members.
SVH Pricewaterhouse Coopers Oy have acted as Authorized Public
Accountants and Hannele Selesvuo as the Authorized Public Accountant.
Future Prospects
It is estimated that the net sales generated by liquid handling
products increases approx. 15% and profitability will stay good in
2002. The net sales generated by diagnostics are anticipated to
develop favorably in 2002.
Biohit's ISO 9001 -quality system covers also the business area of
diagnostics. In addition, Biohit diagnostics conforms also with the
quality requirements set by ISO 13485. This means that Biohit's
diagnostic tests are CE-approved (IVD directive 98/97/EU) and the
tests can, thus, be sold, in addition for research use, also for
clinical use in the EU-area.
In the U.S. the tests can be sold to service laboratories without the
FDA-approval. It is estimated that Biohit will receive FDA-clearance
for the GastroPanel in 2002. Work for obtaining equivalent approvals
in Japan, China and Russia is in progress. Moreover, currently approx.
20 country evaluations are in progress on the basis of which local
experts will recommend Biohit's diagnostic tests to be used. The
results of evaluations finished so far have been positive. The goal of
co-operation with the experts of medical companies, e.g., in Italy and
Germany, is that especially the general practitioners would begin
using the GastroPanel before subscribing medication for patients
suffering from stomach pains and discomfort (evidence-based medicine).
It has been estimated that, e.g., in Italy where the number of general
practitioners exceeds 50,000, the annual need for the GastroPanel-
examination is approx. 2.0 million.
Group Income Statement
1-12 2001 Change 1-12 2000
MEUR % MEUR
Net sales 25.5 5 24.2
Operating expenses -23.0 3 -22.3
Depreciation without
group goodwill depreciation -1.3 -12 -1.4
Operating profit before
group goodwill depreciation 1.2 160 0.5
% Net Sales 4.9% 2.0%
Group goodwill depreciation -1.0 5 -1.0
Operating profit/Loss 0.2 149 -0.5
% Net Sales 0.9% -2.0%
Financial expenses, net -0.2 86 -0.1
Profit/loss before
extraordinary items 0.1 109 -0.6
Extraordinary income 0.0 0 0.2
Profit/Loss before taxes 0.1 116 -0.3
Loss for the period -0.2 62 -0.6
Group Balance Sheet
31.12.2001 31.12.2000
MEUR % MEUR %
Assets
Non-current assets 11.4 46 11.4 47
Current assets
Inventories 4.3 17 3.8 15
Receivables 6.8 27 6.4 26
Cash and cash
equivalents 2.5 10 3.0 12
Total assets 25.0 100 24.6 100
Liabilities and
shareholders' equity
Shareholders' equity
Share capital 2.2 9 2.2 9
Share premium fund 14.9 60 14.9 61
Accumulated
profits/ losses -0.8 -3 -0.6 -3
Capital loans 1.2 5 1.1 5
Minority interest 0.1 0 0.0 0
Long-term liabilities 2.1 8 2.8 11
Short-term
liabilities 5.3 21 4.2 17
Total liabilities
and shareholders'
equity 25.0 100 24.6 100
1-12/01 Change Change-% 1-12/00
Investments,
gross
Fixed assets MEUR 2.1 -5 -70 7.1
Employees, average 289 67 30 222
31.12.2001 31.12.2000
MEUR MEUR
Mortgages and shares pledged
for liabilities
Loans from financial
institutions 1.9 2.8
Corporate mortgages 3.4 3.4
Other long-term liabilities 0.8 0.8
Mortgages 0.8 0.8
Leasing commitments 4.0 4.2
Derivative Contracts
The Group does not have any off balance sheet financial instruments.
Interest on Capital Loans
The unrecorded interest accrued on capital loans totalled to MEUR 0.4
on Dec. 31, 2001 and to MEUR 0.4 on Dec. 31, 2000.
31.12.2001 31.12.2000
Ratios
Equity ratio, % 65.7 66.9
Earnings per share, EUR -0.02 -0.06
Shareholders' equity
per share, EUR 1.28 1.30
Average number of shares 12,643,377 12,573,123
Number of shares at the
end of the period 12,643,377 12,643,377
Proposal for the Distribution of Profit
The Group does not have distributable earnings. The Board of Directors
proposes that no dividends be paid.
The figures of the Interim Report are unaudited.
Helsinki, February 15, 2002
Board of Directors of Biohit Plc.
Helena Hentola
Information Resources and Communications
Additional information: Osmo Suovaniemi, President & CEO, tel: +358-9-
773 861, direct: +358-9-773 86 250, mobile:
+358-40 745 5605
http://www.biohit.com
Distribution: Helsinki Exchanges
The Financial Supervisory Authority
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