The Active Biotech Group Final Accounts Report For The 2000 Operating Year
· SAIK-MS phase I study now also includes MS patients
· TTS phase I study completed
· GAS-vaccine - high protective effect
· Increase in vaccine sales by 26%
· Profit/loss after net financial items (before items affecting
comparability) MSEK -148.6 -according to forecast (MSEK -150)
· Profit/loss after items affecting comparability MSEK -419.3
million (MSEK -62.0)
Clinical studies now include MS patients
A million people worldwide are affected by multiple sclerosis, a chronic
autoimmune disease. The body's own immune defence attacks the myelin
sheaths surrounding the nerve fibres in the brain, disrupting or breaking
the nerve impulses. The disease has a slow, drawn-out cycle and often
occurs in spells with alternating periods of improvement and
There is currently no treatment to halt MS, although beta interferon
injections slow the disease in some patients. Active Biotech has selected
a new treatment strategy with its immunomodulators, which also have the
advantage of being available in tablet form.
At present Active Biotech's substance for the treatment of multiple
sclerosis, SAIK-MS, is in phase I of clinical trials. A phase I study
normally takes the form of a safety study involving healthy volunteers.
The Swedish Medical Products Agency has, however, granted Active Biotech
permission to include MS patients as early as in phase I, as the product
is already regarded as satisfying the necessary safety requirements. The
inclusion of MS patients has now commenced. These trials are expected to
be concluded during the current year.
At the same time as the development work proceeds according to plan,
discussions are being conducted with potential cooperation partners.
TTS phase I study completed
Non small-cell lung cancer (NSCLC) is one of the most commonly occurring
malignant diseases. NSCLC is a disease with one of the highest mortality
rates in the western world, currently affecting some half a million people
every year. There are no effective methods of treatment. NSCLC is
primarily treated today with chemotherapy and surgery.
Renal cancer (RCC) affects fewer people than NSCLC, approximately 80,000
annually, however the medical need is extensive as no satisfactory
treatment currently exists.
Within the TTS (Tumor Targeted Superantigens) project, phase I of the
study relating to non small-cell lung cancer and renal cancer has been
concluded. The preliminary results look promising and the compilation of
the final report is currently under way. Discussions are being conducted
with leading cancer clinics in Sweden and internationally with a view to
commencing phase II trials.
Results from the first clinical trials endorse the company's assessment
that TTS represents a unique concept for cancer treatment. Moreover, the
obtained results give a good starting-point for further development of the
TTS-products towards new indications and applications.
Diarrhoea diseases cause up to four million deaths a year. Infections
caused by cholera or enterotoxin forming E.coli bacteria (ETEC) trigger
off a diarrhoea that, in severe cases, can lead to dehydration and death.
For tourists and business travellers these do not represent the same
threat as the symptoms in these categories generally disappear by
themselves after a short while. On the other hand they are highly
unpleasant and have an extremely limiting effect upon physical mobility
during the days in which the condition is present.
Discussions are being conducted with the American Food and Drug
Administration (FDA) regarding modification of the target effect
("clinical endpoint") for the ongoing ETEC vaccine phase III study in
Guatemala and Mexico, to apply to protection against pronounced diarrhoea
disease. As the company previously reported, the product have shown a
significant vaccination effect for patient groups with pronounced, ETEC
induced, diarrhoea disease.
Work is also proceeding with the registration of the products SBL Cholera
Vaccine and Dukoral internationally, in cooperation with Aventis Pasteur.
The pre-clinical study of Active Biotech's GAS vaccine against
tonsillitis, conducted in cooperation with Vaccine Solutions Pty Ltd. in
Australia, has been concluded. The vaccine consists of peptides from the
streptococcus bacterium's surface structure, produced by Active Biotech in
cooperation with external research groups. One of the peptides in the
study has also been formulated by means of what is known as proteosome
technology in collaboration with the Canadian vaccine company Intellivax.
Results from this study indicate a vaccine with a high protective effect,
85-90%, even when administered intranasally against infection caused by
streptococci. The company considers the patent protection as being strong
for all the antigens. Discussions are being conducted with regard to
extended cooperation with Intellivax and Vaccine Solutions. Planning of
the clinical development has commenced and a phase I study can start in
the first half of 2002.
The sale of the CDT technology (Covalent Display Technology) has been
completed. The project has been spun off to a newly-formed company,
Isogenica Ltd., in which Active Biotech remains as a minority shareholder
with a 20 per cent share.
Increase in vaccines sales by 26%
The increase in turnover, excluding income for contract research, amounted
Vaccine sales increased by 26% to MSEK 234.5 (MSEK 184.5). The growth is
primarily attributable to continued strong development for SBL Cholera
Vaccine and Dukoral, which increased sales by 97% to MSEK 64.4 (MSEK
32.7). Dukoral continues to show a strong sales growth in Sweden and
Sales in Sweden increased by 52% to MSEK 27.0 (MSEK 17.8). In Norway,
where the product was launched in 1998, sales increased by 106% to MSEK
6.8 (MSEK 3.3).
This positive development is explained by increased market penetration and
solid growth in the number of travellers to the risk areas.
SBL Cholera Vaccine also shows a strong growth in comparison with the
preceding year. Sales increased by 176% to MSEK 28.9 (MSEK 10.5).
Sales of agency products within the vaccine sector developed less
favourably during the year, falling by 2% to MSEK 58.0 (MSEK 59.0). The
decrease is primarily attributable to ongoing supply problems, including
those relating to influenza vaccines. Distribution orders showed a 25%
sales increase to MSEK 99.5 (MSEK 79.7).
Net turnover specified according to activity
% of % of
Vaccine sales 2000 1999 % 2000 1999
Own produced vaccines 76.9 46.8 64% 32.8% 25.5%
Dukoral/SBL Cholera 64.4 32.7 97%
Other products 12.5 14.1 -11%
AGENCY PRODUCTS 58.0 59.0 -2% 24.7% 31.8%
Distribution orders 99.5 79.7 25% 42.5% 43.0%
Total vaccine sales 234.5 185.4 26% 100.0% 100.0%
INCOME FROM CONTRACT 40.0 75.0 -47%
Other income 5.9 6.9 -15%
Total net turnover 280.4 267.3 5%
Profit/loss after net financial items MSEK -148.6 (before items affecting
In accordance to the previously reported decision that all research
projects will be accounted for as costs on a continuos basis, the year's
result has been debited with a one-off write-off of previous years'
capitalised research costs relating to the vaccine business. The write-off
amounts to MSEK 270.2, and will not influence the group's cash-flow.
The operating profit/loss before financial items, amounted to MSEK -509.5
(MSEK -112.3). The negative development is explained by items affecting
comparability in 2000 and 1999. The current year's result has been debited
with MSEK 270.8, of which a one-off write-off of intangible assets amounts
to MSEK 270.2. The 1999 result included one-off income derived from
property and site sales, amounting to MSEK 139.6.
The result before items affecting comparability was thereby improved by
MSEK 13, despite a reduction in income from contract research by MSEK 35,
when Active Biotech acquired all the rights to the TTS project from
Pharmacia and now finances the further development under its own
The Group's net profit/loss after net financial items improved strongly,
from MSEK 54.7 in 1999 to MSEK 90.0 this year, reflecting profits from the
disposal of the shares in Lifco AB, realised profits in the Zenit fund as
well as, in general, a good development for the financial investments.
The positive profit/loss development for comparable units and
extraordinary depreciation, is explained by a strong sales growth, a
restrictive cost development and also a strong net result after net
The operating profit/loss after net financial items, but before items
affecting comparability, amounted to MSEK -148.6 (MSEK -62.0), in line
with the submitted full year forecast of MSEK -150. The profit/loss after
depreciation of intangible assets amounted to MSEK -419.3 (MSEK -62.0).
Equity capital amounted to MSEK 645.9. Solvency as at 31 December 2000
amounted to 74.3% (74.0%). Liquid funds and financial investments amount
to MSEK 416 (MSEK 545).
The Board does not intend recommending a dividend to be paid to the
shareholders for the 2000 operating year.
General meeting of shareholders
An ordinary general meeting of shareholders will take place on Thursday,
29 March, 2001 at 17.00 at the Scandic Star Hotel, Lund, Sweden.
Future publication of information
· Complete annual report and accounts available at the beginning of
· Quarterly reports to be published on 9 May, 8 August and 6
· Final accounts report for the complete year 2001 to be published
on 14 February 2002
Lund, 15 February 2001
Active Biotech AB (Publ)
President & CEO
Active Biotech AB is a biotechnics company focusing on research and
development of medicines and vaccines. Our expertise lies in the knowledge
of the human immune defence system. We have a high-quality project
portfolio and financial strength. The most important products and projects
are medicines for multiple sclerosis (SAIK) and cancer (TTS), the SBL
Cholera Vaccine, and Dukoral and ETEC vaccines against tourist diarrhoea.
Active Biotech's turnover was MSEK 280 in 2000.
Active Biotech AB
Box 724, SE-220 07 Lund, Sweden
Tel: +46 (0)46-19 20 00
Fax: +46 (0)46-19 20 50