2009-03-27 07:30:00 CET
2009-03-27 07:31:54 CET
REGULATED INFORMATION
Biotie Therapies - Financial Statement Release
Biotie Therapies Corp. Financial Statement Release January 1 - December 31, 2008
BIOTIE THERAPIES CORP. STOCK EXCHANGE RELEASE March 27, 2009 at
8.30 a.m.
BIOTIE THERAPIES CORP. FINANCIAL STATEMENT RELEASE JANUARY 1 -
DECEMBER 31, 2008
The year 2008 in brief
- In January Lundbeck acquired the United Kingdom and Ireland rights
for Nalmefene from Britannia Pharmaceuticals.
- In June Biotie announced top-line data from the first-in-man
clinical study with its fully human VAP-1 monoclonal antibody.
- In September top-line data were released of the clinical trial with
Nalmefene evaluating potential cardiac effects.
- In November Biotie acquired the pharmaceutical discovery and
development company elbion GmbH.
- In November Lundbeck initiated three phase III clinical trials with
Nalmefene for the treatment of alcohol dependence.
- The net loss in January - December stood at EUR 5.5 million (net
loss in 2007 EUR 1.7 million). Cash flow in January - December from
operating activities was EUR -9.4 million (EUR -5.3 million in 2007).
- Revenue for January - December stood at EUR 5.1 million (EUR 7.9
million in 2007) and earnings per share was EUR -0.06 (EUR -0.02 in
2007).
- The company's liquid assets amounted to EUR 25.2 million as at
December 31, 2008 (EUR 28.2 million as at December 31, 2007).
Events after 2008
- In February and March 2009 Biotie started clinical studies in
rheumatoid arthritis and psoriasis patients, respectively, with its
fully human VAP-1 monoclonal antibody
- In March 2009 Lundbeck acquired the North-American and Mexican
rights for Nalmefene from Somaxon Pharmaceuticals. Following this,
Lundbeck has worldwide rights for Nalmefene, excluding Turkey and
South-Korea.
Annual General Meeting
Biotie's Annual General Meeting will be held at the auditorium of
Restaurant Alabama in Turku on Friday, May 29, 2009 at 10.00 a.m.
Financial Statements 2008
The Financial Statements 2008 will be published on March 27, 2009.
IFRS and Accounting principles
The 2008 financial statement release has been prepared in accordance
with IFRS recognition and measurement principles, and applying the
same accounting policy as for the 2007 financial statements. The
financial statement does not comply with all requirements of IAS 34,
Interim Financial Reporting. The figures presented in this financial
statement release have been audited.
Q4/2008 in brief:
- Biotie acquired the pharmaceutical discovery and development
company elbion GmbH in November against issuing 46,802,967 new shares
as consideration.
- Biotie offered 7,305,733 new shares for certain investors'
subscription for a total of EUR 3.3 million. New shares were
registered on 17 November 2008.
- Lundbeck initiated three phase III clinical trials with Nalmefene
for the treatment of alcohol dependence in November.
- The net loss in October - December, 2008 stood at EUR 1.7 million
(net loss for the comparable period in 2007 EUR 2.4 million). Cash
flow in October - December from operating activities was EUR -1.5
million (EUR -1.2 million during the comparable period in 2007).
- Revenue for October - December, 2008 stood at EUR 1.2 million (EUR
1.2 million in comparable period in 2007) and earnings per share was
EUR -0.01 (EUR -0.03 in the fourth quarter 2007).
Review of the financial year
General:
Biotie is a drug discovery and development company focused on central
nervous system and inflammatory diseases. It has a broad range of
innovative small molecule and biological drug candidates at different
stages of clinical and pre-clinical development.
Biotie's products address diseases with high unmet medical need and
significant market potential, including addiction and psychotic
disorders, rheumatoid arthritis, psoriasis and chronic obstructive
pulmonary disease (COPD). The most advanced product, Nalmefene for
alcohol dependence, is currently in phase III clinical development by
licensing partner Lundbeck.
In November 2008, Biotie acquired Radebeul, Germany based drug
discovery and development company elbion GmbH through issuance of new
shares to its previous owner, elbion NV of Leuven, Belgium.
Subsequently, the newly acquired subsidiary was renamed into Biotie
Therapies GmbH. Concomitantly, certain investors of elbion NV
subscribed to a share offer by Biotie, by which EUR 3.3 million fresh
capital were raised.
Together, the combined entity has a broad range of innovative
therapeutic products for the treatment of inflammatory and CNS
diseases. Biotie has operations in Turku, Finland and Radebeul,
Germany.
Drug development projects:
Central nervous system diseases:
Nalmefene, a new treatment paradigm for alcohol dependence
Biotie's Nalmefene is an oral opioid receptor antagonist that is
being developed for the treatment of alcohol dependence.
Nalmefene builds on a novel principle of treating alcohol dependence.
Unlike existing therapies, the treatment with Nalmefene is not aimed
at keeping the patients from drinking. Nalmefene instead removes the
desire to drink more, thereby controlling and limiting the intake of
alcohol. In addition, Nalmefene distinguishes itself by being
available as a tablet formulation to be taken only according to need,
whereas existing pharmaceuticals must be taken continuously over a
longer period of time.
Biotie and Lundbeck signed a licensing agreement at the end of 2006
on worldwide rights for Nalmefene, excluding North America, Mexico,
UK, Ireland, Turkey, and South Korea which had already been licensed.
This license agreement entered into force in May 2007. In the
beginning of 2008, UK and Ireland rights were acquired by Lundbeck
from Britannia Pharmaceuticals and after the reporting period in
March 2009 Lundbeck acquired the North-American and Mexican rights
from Somaxon Pharmaceuticals. Following this, Lundbeck has worldwide
rights for Nalmefene, excluding Turkey and South-Korea.
Biotie-Lundbeck license agreement terms have been amended due to the
transfer of rights. Under the terms of the amended agreement, Biotie
is now eligible for up to EUR 84 million in upfront and milestone
payments plus royalty on sales. Of the EUR 84 million, Biotie has
already received an execution fee of EUR 12 million from Lundbeck.
Marketing and distribution rights in Turkey and South Korea have been
licensed to Eczacibasi Ilac Pazarlama A.S., and Whanin Pharmaceutical
Co. Ltd., respectively.
Biotie's previously conducted study in 400 alcoholic patients
documented Nalmefene's ability to significantly limit both the
patient's average alcohol intake and the number of days with an
intake above five units of alcohol. Previous trials have also shown
Nalmefene to be well-tolerated and safe.
In September top-line data were released of the clinical trial with
Nalmefene evaluating potential cardiac effects on 240 healthy
volunteers measured using an electrocardiogram. The data from the
study indicate that use of Nalmefene does not increase the risk of
adverse cardiac effects and that current regulatory requirements for
such studies are met.
Based on the earlier Biotie-sponsored trials, Lundbeck in the end of
2008 launched three phase III trials, which will enroll more than
1,800 patients to be randomised into groups receiving Nalmefene or
placebo. The first two trials, in which patients are treated over a
period of six months, primarily aim to demonstrate the efficacy of
Nalmefene, whilst the objective of the last study, in which patients
are treated for 12 months, is particularly to confirm that the
compound is well-tolerated. The first data from the trials are
expected in the first half of 2011. Biotie will participate in
financing some of the clinical development costs.
Buprenorphine Depot
Buprenorphine is the most widely used drug for substitution therapy
of opioid-addicted patients. Biotie's portfolio includes a depot
formulation Buprenorphine product development project. The goal is to
produce a once-monthly Buprenorphine injection, which aims to provide
a more effective way to treat opioid dependence than that currently
available from existing oral Buprenorphine or other products. The
project is currently in the preclinical phase of development.
Phosphodiesterase 10 (PDE10) inhibitors, a novel treatment paradigm
for Schizophrenia
PDE10 is a novel molecular drug target in schizophrenia and Biotie
has shown antipsychotic activity of PDE10 inhibitors in animal
models. Biotie's PDE10 inhibitors are believed to serve the unmet
medical need for novel anti-psychotic drugs with an improved side
effect profile and improved efficacy in schizophrenia.
The PDE10 discovery and development program was partnered with Wyeth
Pharmaceuticals in December 2006. On the basis of a Research
Collaboration and License Agreement between Biotie and Wyeth
Pharmaceuticals, scientists of both companies work closely together
to profile and develop novel drug candidates.
In total, Biotie is eligible to - depending on the progress of the
development candidates - up to USD 110 million in signing fee,
milestone payments and research funding. Biotie will in addition be
eligible for royalties on sales.
Inflammatory diseases:
ELB353, an oral PDE4 inhibitor for COPD in clinical development
ELB353 is a phosphodiesterase 4 (PDE4) inhibitor, with therapeutic
potential in chronic inflammatory disorders, particularly in chronic
obstructive pulmonary disease (COPD), a serious disorder with major
unmet medical need.
In preclinical testing, ELB353 is a potent disease modifier in animal
models of COPD, asthma, psoriasis, atopic dermatitis, rhinitis,
rheumatoid arthritis. More importantly, when compared to certain
other PDE4 inhibitors in late clinical development, ELB353 treatment
was well tolerated with respect to central nervous system and
gastrointestinal side effects, which have posed a significant
development hurdle for PDE4 inhibitors until now.
In its first Phase I study, ELB353 was found to be safe and well
tolerated after single and multiple dosing and no severe, significant
or serious adverse events occurred. Blood plasma profiles of ELB353
showed pronounced and long lasting exposure both after single and
multiple doses. The long terminal half life after multiple dosing
indicates an excellent suitability for once daily dosing.
VAP-1, a key inflammation receptor
Vascular Adhesion Protein-1 (VAP-1) is Biotie's proprietary target
and is protected by patents held by the company. VAP-1 has been shown
to play a key role in mediating the inflammatory events associated
with chronic diseases such as rheumatoid arthritis, psoriasis and
diabetes. Blocking VAP-1 function is expected to alleviate
inflammatory conditions associated with these and, potentially, other
chronic inflammatory diseases for which there is a clear unmet
medical need.
VAP-1 function can be blocked by either antibody (biologic) drugs or
small molecule drugs which target the enzyme (SSAO) domain of the
receptor. Both these approaches are being pursued by Biotie for
different therapeutic indications.
VAP-1 antibody, a high value biologic for inflammatory diseases in
clinical development
Biotie is developing a fully human monoclonal antibody which blocks
VAP-1 function thereby allowing the inflammation to resolve. Biotie
completed the first-in-man, single dose, placebo-controlled clinical
study with the VAP-1 antibody in the second quarter of 2008. A total
of 29 subjects received the antibody which was generally well
tolerated. No serious adverse events were reported.
Development activity to support the clinical program continued
throughout the year and after the reporting period in February and
March 2009 Biotie started multiple dose clinical studies in
rheumatoid arthritis and psoriasis patients, respectively, with its
fully human VAP-1 monoclonal antibody. These studies aim to establish
appropriate dosing regimens for subsequent therapeutic studies and
provide initial information on the antibody's therapeutic potential.
The Finnish Funding Agency for Technology and Innovation (Tekes)
granted EUR 0.6 million additional funding for the VAP-1 antibody
program in September 2008. The R&D funding granted covers costs of a
planned clinical PET-imaging study project from August 2008 to
December 2009. The funding granted is in the form of a loan and
covers 70 per cent of the costs of the study. The loan will be paid
to Biotie against reported realized costs. In order to receive the
full amount of granted financing, Biotie must show a total
expenditure of EUR 0.8 million in the project.
Biotie and Roche have signed an option agreement for Biotie's fully
human antibody program targeting VAP-1 in inflammatory diseases in
2006. Roche has paid Biotie EUR 5 million, which grants Roche an
exclusive option right to an exclusive, worldwide license agreement
for Biotie's VAP-1 antibody, excluding Japan, Taiwan, Singapore, New
Zealand, and Australia. The initial option right will end upon
completion of phase I.
Seikagaku Corporation has licensed the rights for the product for
Japan, Taiwan, Singapore, New Zealand, and Australia against up to
USD 16.7 million in milestone payments plus royalties of sales in the
territory. Biotie has already received USD 2.7 million from
Seikagaku.
Research
VAP-1 SSAO inhibitors
Biotie and Roche collaborate to develop small molecule VAP-1 SSAO
inhibitors to Roche specifications. Under the terms of the
collaboration, both parties carry their own costs, but Biotie retains
ownership of the developed compounds until Roche chooses to exercise
its option for in-licensing. Under the terms of the collaboration and
option agreement, Roche may pay Biotie up to EUR 5 million to
maintain its exclusive option for rest-of-world rights excluding
Seikagaku's territory (Japan, Taiwan, Singapore, New Zealand and
Australia).
Seikagaku has an option to license a VAP-1 enzyme inhibitor in this
territory. If Seikagaku exercises its option, Biotie will receive up
to USD 16.7 million in milestone payments plus royalties of sales in
the territory based on the pre-negotiated licensing agreement.
Seikagaku will also be responsible for clinical development costs to
bring the product to market in the territory.
Novel phosphodiesterase (PDE) inhibitors for the treatment of central
nervous system diseases
Biotie has discovered new small molecule PDE inhibitors that show
pronounced activity in animal models of memory enhancement, anxiety
and depression. Biotie is profiling these compounds with respect to
their therapeutic potential and as candidate drugs.
alfa2beta1 integrin inhibitors have potential in thrombosis, cancer
and inflammation.
Biotie is profiling its alfa2beta1 integrin inhibitors with respect
to their therapeutic potential and as candidate drugs.
Bioheparin
Biotie's Bioheparin is a non-animal-derived heparin and is produced
using technology patented by the company. Biotie is seeking a
development partner for the Bioheparin program.
Revenues
Revenue for the financial year 2008 was EUR 5.1 million. Revenue
consisted of income from an ongoing research collaboration with
Wyeth, periodization of the signing fees of the licensing agreements
signed with Seikagaku Corporation in 2003 and with Somaxon
Pharmaceuticals in 2004, periodization of the option fee of the
option agreement signed with Roche in 2006, periodization of the
signing fee received from Wyeth in 2006 as well as periodization of
the execution fee of the licensing agreement signed with Lundbeck
that entered into force in May 2007.
Revenue for the financial year 2007 was EUR 7.9 million. Revenue
consisted of periodization of the signing fees of the licensing
agreements signed with Seikagaku Corporation in 2003 and with Somaxon
Pharmaceuticals in 2004, periodization of the option fee of the
option agreement signed with Roche in 2006 as well as periodization
of the execution fee of the licensing agreement signed with Lundbeck
that entered into force in May 2007.
Financial results
The net loss for the financial year 2008 was EUR 5.5 million. The
corresponding figure for the previous year was EUR 1.7 million.
Research and development costs for the period amounted to EUR 8.7
million (in 2007 EUR 9.1 million). Patent costs have been booked as
expenses.
Financing
Biotie's equity ratio was 0.3 % on December 31, 2008 (-37.0 % on
December 31, 2007).
Cash and cash equivalents totaled EUR 25.2 million on December 31,
2008 (EUR 28.2 million on December 31, 2007).
As from the second quarter 2008, the company has invested its liquid
assets into bank deposits. Funds are reported in "investments held to
maturity". Deposits with maturity less than 3 months are reported in
the "cash and cash equivalents". Previously the funds were invested
in money market funds.
In September 2008, The Finnish Funding Agency for Technology and
Innovation (Tekes) granted EUR 0.6 million additional funding for
Biotie Therapies' VAP-1 antibody program. The R&D funding granted
covers drug development costs of the project from August 2008 to
December 2009.
The funding granted is in the form of a loan and it covers about 70
per cent of the costs of the project. The loan will be paid to Biotie
against reported realized costs. In order to receive the full amount
of granted financing, Biotie must show a total expenditure of EUR 0.8
million in the project.
In January 2008, The Finnish Funding Agency for Technology and
Innovation (Tekes) granted EUR 1.7 million additional funding for
Biotie Therapies' integrin alpha2beta1 inhibitor program for
thrombosis. The R&D funding granted covers drug development costs of
the project from July 2007 to December 2009.
The funding granted is in the form of loan and it covers 50 per cent
of the costs of the project. The loan will be paid to Biotie against
reported realized costs. In order to receive the full amount of
granted financing, Biotie must show a total expenditure of EUR 3.4
million in the project.
In August 2007, the central development agency for the state of
Saxony(SAB, Sächsische Aufbaubank) has awarded a research and
technology grant for drug discovery and early development activities
to the German subsidiary Biotie Therapies GmbH in the amount of EUR
3.8 million. The money has been awarded as a non refundable grant to
be drawn down during the period between August 2007 and July 2010
against reported realized costs. As of 1 January 2009, EUR 2.4
million of this grant are still available to the company. The grant
covers 65% of personnel and project related cost, so Biotie Therapies
must show a total expenditure of EUR 3.6 million until July 2010 in
relation to the project in order to benefit from the full amount
still available.
Shareholder's equity
The shareholders' equity of the company amounts to EUR 0.1 million.
According to Finnish accounting standards, shareholders' equity is
less than half of the company's share capital The company's share
capital is EUR 44.3 million, shareholders' equity is EUR 14.5 million
and capital loans stand at EUR 21.3 million. Thus, shareholders'
equity plus capital loans add up to EUR 35.8 million. The Company
does not have funds that could be used for profit distribution.
The Annual General Meeting was held on March 28, 2008 and considered
measures relating to the level of shareholders' equity. It was
resolved that no special measures are necessary at this point in
time.
The company has in its possession 819.000 of its own shares. In
relation to the company's option programs, the company has signed a
stock lending agreement with EVLI Bank. Pursuant to this agreement,
the number of the company's own shares in its possession may be
temporarily less than 819,000.
Investments and cash flow
The cash flow from operations was EUR -9.4 million (in 2007 EUR -5.3
million). During the financial year 2008, the company received in
total EUR 0.6 million from ongoing collaborations, grants and
partnering agreements. The company's investments during the financial
year amounted to EUR 0.1 million (EUR 0.3 million in 2007).
Personnel
During the financial year, the company's personnel was on average 42
(36 in 2007) and at the end of the financial year, 80 (37 on
31.12.2007).
Changes in Management Team
Since the acquisition of elbion GmbH, the management of the company
is comprised of the following individuals:
Name Position in the company
Timo Veromaa Chief Executive Officer
Antero Kallio Chief Medical Officer
Thomas Kronbach Chief Scientific Officer
Thomas Taapken Chief Financial Officer
Kai Lähdesmäki serves as a senior business development advisor for
the company.
Biotie's Extraordinary General Meeting of Shareholders, held on
November 14, 2008 appointed Ann Hanham, Bernd Kastler and Christoph
Schroeder as additional new members of the Board of Directors of
Biotie.
Group structure
The parent company of the group is Biotie Therapies Corp. The
domicile of the Company is Turku, Finland. The Group has an operative
subsidiary, Biotie Therapies GmbH, located in Radebeul, Germany.
The group also has a non-operational subsidiary named Biotie
Therapies International Ltd in Finland and an associated company with
no activities, Contral USA which is domiciled in Delaware USA.
Shareholders' meetings held during the financial year
Decisions taken at Annual General Meeting
The Annual General Meeting of Biotie Therapies Corp. was held on
March 28, 2008.
The General Meeting of Shareholders adopted the income statement and
balance sheet and the consolidated income statement and balance sheet
for the financial year 1 January, 2007 - 31 December, 2007. The
General Meeting of Shareholders resolved pursuant to the proposal of
the Board of Directors that the loss of the financial year, EUR
1,624,388.72 shall be transferred to the company's equity.
The General Meeting of Shareholders discharged the members of the
Board of Directors and the President and CEO from liability
concerning the financial year from 1 January - 31 December 2007.
The Board of Directors and Auditors
The number of the members of the Board of Directors was resolved to
be five. Juha Jouhki, Pauli Marttila, Riku Rautsola and Piet Serrure
were re-elected as the members of the Board of Directors and Mr.
Krish Krishnan was appointed as a new Board member.
Janne Rajalahti, Authorized Public Accountant, and
PricewaterhouseCoopers Oy, Authorized Public Accountants, were
elected as auditors of Biotie Therapies Corp.
At the organization meeting of the new Board of Directors, which
convened immediately after the Annual General Meeting, Juha Jouhki
was elected as the Chairman of the Board of Directors and Pauli
Marttila as the deputy chairman.
Authorization of the Board of Directors to resolve on a share issue
and granting of option and other specific rights entitling to the
shares
The Annual General Meeting authorized the Board of Directors to
resolve on one or more share issues, which contains the right to
issue new shares or dispose of the shares in the possession of the
company and to issue options or other specific rights to the shares
pursuant to chapter 10 of the Finnish Companies Act. The
authorization consists of up to 18,000,000 shares in the aggregate. A
maximum of 819,000 own shares in the possession of the company may be
conveyed.
The authorization does not exclude the Board of Directors' right to
decide on a directed share issue. The authorization is used for
possible material arrangements from the company's point of view, such
as financing or implementing business arrangements or investments or
for other such purposes determined by the Board in which case a
weighty financial reason for issuing shares, options or other
specific rights and possibly directing a share issue would exist.
However, the authorization could not be used to create new
share-based incentive schemes. The authorization shall remain
effective until 30 June 2009.
Issuance of new stock options
The Annual General Meeting decided to issue up to 3,000,000 stock
options in the aggregate which would entitle to subscribe for up to
3,000,000 new shares in the company.
The Extraordinary General Meeting resolved to revoke the option
program approved by the Annual General Meeting of Shareholders on 28
March 2008 and based on which program no option rights had been
allocated.
Resolutions of the Extraordinary General Meeting
The Extraordinary General Meeting of Biotie Therapies Corp. was held
on November 14, 2008. The Meeting resolved to approve all proposals
by the Board.
To complete the transaction regarding elbion GmbH, the General
Meeting of Shareholders of Biotie resolved, in deviation from the
shareholders' pre-emptive subscription right, to offer: (i)
46,802,967 new shares to elbion NV as consideration for total share
capital of elbion GmbH and (ii) up to 7,305,733 new shares to be
subscribed by certain funds held or managed by Burrill & Company, TVM
Capital and AGF Private Equity.
The subscription price for the shares was set at EUR 0.4517 per
share. The subscription price had been determined by calculating the
trade weighted average of the Company's share price during the 20
trading days prior to and including 22 October 2008.
The subscription price was recorded in the company's share capital
(FAS). In IFRS accounting share capital increase was recorded at the
fair value of the shares at the date of transaction which was EUR
0.29 per share and it was based on the published price at the date of
exchange.
Authorization to the Board of Directors to resolve on a share issue
and granting of option and other specific rights entitling to the
shares
The Extraordinary General Meeting authorized the Board of Directors
to resolve on one or more share issues which contains the right to
issue new shares or dispose of the shares in the possession of the
company and to issue options or other specific rights to the shares
pursuant to chapter 10 of the Companies Act. The authorization
consists of up to 7,000,000 shares in the aggregate. A maximum of
819,000 own shares in the possession of the Company can be conveyed.
The authorization does not exclude the Board of Directors' right to
decide on a directed share issue. The authorization can be used for
material arrangements from the company's point of view, such as
financing or implementing business arrangements or investments or for
other such purposes determined by the Board of Directors in which
case a weighty financial reason for issuing shares, options or other
specific rights and possibly directing a share issue would exist.
Further, the authorization can be used to create new share-based
incentive schemes. The authorization shall be effective until 1 April
2010.
The Extraordinary General Meeting resolved to revoke the option
program approved by the Annual General Meeting of Shareholders on 28
March 2008 and based on which program no option rights had been
allocated.
Election of new Board Members
The Extraordinary General Meeting elected Ann Hanham, Bernd Kastler
and Christoph Schroeder to the Board of Directors in addition to the
present members of the Board of Directors.
Option programs
By 31 December 2008 Biotie Therapies Corp. had issued option rights
pursuant to two different option programs (2004 and 2006 option
rights). At the beginning of the financial year the number of 2004
option rights was 2,000,000 and 2006 option rights was 2,768,800.
During the financial year 2007 a total of 231,200 new shares in
Biotie Therapies Corp. were subscribed for by exercising a portion of
the 2006 option rights of the company's option scheme. During the
financial year 2008 no new shares were subscribed under the existing
option programs.
The remaining outstanding Biotie 2004 and 2006 option rights entitle
their holders to subscribe for a total of 4,768,800 new shares of the
company.
Share capital and Shares
Biotie's shares are quoted on the NASDAQ OMX Helsinki Oy (Small cap,
Healthcare). Biotie Therapies has 144,320,560 shares and the share
capital amounts to EUR 44,290,678.10 (under Finnish Accounting
Standards, FAS). All the company's shares are of the same series and
have equal rights. All the shares are freely transferable and contain
one voting right each.
At the end of the financial year the share price was EUR 0.26 The
highest price for Biotie's share during the financial year was EUR
0.94 and the lowest was EUR 0.24. The average share price was EUR
0.51. Biotie's market capitalization at the end of the financial year
was EUR 37.52 million (2007: EUR 68.56 million).
In accordance with the acquisition and based on the Extraordinary
General Meeting held on November, during 2008 the company's share
capital increased by EUR 24,440,899.79 (FAS) and the total number of
shares outstanding now amounts to 144,320,560. In IFRS accounting
share capital amounts to EUR 36,360,868.43. The difference is caused
by different treatment of subscription price in FAS and IFRS
accounting.
During the financial year 2008, 15,350,613 (2007: 35,093,743 Biotie
shares were traded corresponding to a turnover of approximately EUR
7.92 million (2007: EUR 34.15).
At the end of the financial year 2008 the company had 6,580
shareholders compared to 6,340 at the end of 2007.
Shares and options held by management
At the end of financial year 2008 the amount of company's shares held
by the Board of Directors and CEO and their controlled companies is
totally 6,537,886 shares and 1,134,400 option rights.
Changes in ownership
During the period under review, the company became aware of two
notices of change in ownership exceeding the disclosure threshold.
Information on notices of change in ownership is available on the
company's website at www.biotie.com/investors.
The ten biggest shareholders of Biotie on 31 December, 2008
Number of
shares %
elbion NV 46,802,967 32.61
Finnish Innovation Fund (Sitra) 14,585,350 10.16
Finnish Industry Investment Ltd 6,778,592 4.72
Juha Jouhki and his controlled companies: 6,537,672 4.56
- Dreadnought Finance Oy (2,098,416)
- Jouhki Juha (1,501,356)
- Thominvest Oy (2,937,900)
Funds administered by BioFund Management Oy: 2,485,715 1.73
- BioFund Ventures III Ky (2,485,715)
Harri Markkula and his controlled company: 1,349,431 0.94
- Tilator Oy (369,700)
- Markkula Harri (979,731)
Alfred Berg Small Cap Finland Fund 1,270,000 0.89
Oy H. Kuningas & Co AB 1,058,371 0.74
Oksanen Markku 860,000 0.60
Funds administered by Aboa Venture Management
Oy 344,618 0.24
- Aboa Venture Ky II (336,747)
- Karhu Pääomarahasto Ky (7,871)
82,072,716 57.19
Nominee registered shares total 30,918,736 21.55
Other shareholders 30,510,108 21.26
Outstanding shares 143,501,560 100.00
The number of the company's own shares held
by Biotie Therapies 819,000*)
Total 144,320,560
*) The company has in its possession 819,000 of its own shares.
Relating to the company's option programs, the company has signed a
stock lending agreement with EVLI Bank. Pursuant to this program, the
number of the company's own shares in its possession may be
temporarily less than 819,000.
Short-term risks and uncertainties
Biotie's strategic risks are predominantly related to the technical
success of the drug development programs, regulatory issues, the
strategic decisions of its commercial partners, ability to obtain and
maintain intellectual property rights for its products, validity of
its patents, launch of competitive products and the development of
the sales of its products and availability of funds to support itsoperations. For example, even though the commercialization and
collaboration agreements on the company's product development
projects have been concluded, there can be no assurance that the
contracting partner will act in accordance with the agreement, the
authorities will approve the product under development or the
approved product will be commercialized. The development and success
of the company's products depends to a large extent on third parties.
The operational risks include dependency of key personnel, assets and
dependency on partners' decisions.
Significant financial resources are required to advance the drug
development programs into commercialised pharmaceutical products. The
Group relies on its ability to fund the operations of the Group
through three major sources of financing. Entering into
commercialization, collaboration and licensing agreements with larger
pharmaceutical companies entitles the Company and its subsidiaries to
receive up-front, milestone dependant and royalty payments from these
partners. In addition, the Company relies on different sources of
research and development grants and loans. These funds, which are
provided through regional, national or EU level institutions with the
aim of fostering economic and technological progress in the region in
which the Group operates, have been historically available to Biotie
at substantial levels. Availability of such funds in the mid- to long
term future cannot be guaranteed and thus this poses a potential risk
to the income situation of the Group in the future. Furthermore, the
Company relies on capital market to raise equity and debt financing
from time to time. There can be no assurance that sufficient
financing can be secured in order to permit the Company to carry out
its planned activities. To protect the continuity of Biotie's
operations, sufficient liquidity and capital has to be maintained and
the Company and its subsidiaries. The Group aims to have cash funds
to finance at least one year's operations at all times. The Group caninfluence the amount of capital by adapting its cost basis according
to the financing available. Management monitors the capital and
liquidity on the basis of the amount of equity and cash funds. These
are reported to the Board on a monthly basis.
Future outlook
- During 2009, Biotie will provide support to its license partner
Lundbeck for the ongoing phase III studies with Nalmefene in alcohol
dependence.
- Biotie will perform two clinical studies with its proprietary VAP-1
antibody in psoriasis and rheumatoid arthritis patients in the course
of 2009. Results of these studies will become available in the first
half of 2010.
- The company intends to initiate a clinical trial for its
proprietary, small molecule PDE-4 inhibitor ELB353 with the aim to
obtain proof of pharmacodynamic activity in humans, corroborate the
safety profile and establish dose ranges for further therapeutic
studies.
- In its collaboration with Wyeth on the discovery and development of
novel PDE10 inhibitors for the treatment of psychiatric disorders,
Biotie and its partner intend to identify development candidates.
- Completion of the integration of operations of the recently
acquired German subsidiary Biotie Therapies GmbH.
The Board of Directors proposal for handling of the loss
The Board of Directors proposes that no dividend from the financial
year 2008 will be paid, and that the loss of the parent company for
the financial year EUR -6.3 (FAS) million will be transferred to
shareholders' equity.
In Turku, March 27, 2009
Biotie Therapies Corp.
Board of Directors
For further information, please contact:
Timo Veromaa, President and CEO
tel. +358 2 274 8900, e-mail: timo.veromaa@biotie.com
Thomas Taapken, CFO
tel. +358 2 274 8900, e-mail: thomas.taapken@biotie.com
www.biotie.com
Distribution:
NASDAQ OMX Helsinki Ltd
Main Media
APPENDICES TO THE FINANCIAL STATEMENTS
Income statement
Balance sheet
Statement of changes in shareholders' equity
Cash flow statement
Key figures
INCOME STATEMENT
consolidated figures
(IFRS)
1.10.- 1.10.- 1.1.- 1.1.-
31.12.2008 31.12.2007 31.12.2008 31.12.2007
EUR 1,000 3 months 3 months 12 months 12 months
Revenue 1,177 1,165 5,127 7,895
Research and -2,454 -3,241 -8,730 -9,053
development expenses
General and -819 -379 -2,020 -1,655
administrative expenses
Other operating income 323 174 502 1,044
Operating profit/loss -1,773 -2,281 -5,121 -1,769
Financial income 924 132 1,432 860
Financial expenses -902 -220 -1,864 -817
Profit/loss before taxes -1,751 -2,369 -5,553 -1,726
Taxes 76 0 76 0
Net income/loss -1,675 -2,369 -5,477 -1,726
Distribution
To parent company -1,675 -2,369 -5,477 -1,726
Shareholders
Earnings per share (EPS) -0.01 -0.03 -0.06 -0.02
basic & diluted, EUR
BALANCE SHEET
consolidated figures (IFRS)
EUR 1,000 31.12.2008 31.12.2007
Assets
Non-current assets
Intangible assets 10,352 747
Goodwill 379 0
Property, plant and equipment 2,792 332
Financial assets at fair value through 0 14,938
profit or loss
13,523 16,017
Current assets
Prepaid expenses 2,400 0
Available for sale investment 131 0
Investments held to maturity 18,500 0
Accounts receivables and other receivables 1,512 753
Financial assets at fair value through 0 13,000
profit or loss
Cash and cash equivalents 6,738 305
29,281 14,058
Total 42,804 30,075
Equity and liabilities
Shareholders' equity
Share capital 36,361 19,850
Reserve for invested unrestricted equity 980 980
Retained earnings -31,754 -30,220
Net income/loss -5,477 -1,726
Shareholders' equity total 110 -11,117
Non-current liabilities
Provisions 121 14
Non-current financial liabilities 24,930 23,603
Pension benefit obligation 574 0
Other non-current liabilities 5,881 4,930
Non-current deferred revenues 2,966 5,168
Deferred tax liabilities 1,859 0
36,331 33,715
Current liabilities
Provisions 641 20
Pension benefit obligation 10 0
Current financial liabilities 144 104
Current deferred revenues 3,501 5,741
Accounts payable and other current debts 2,067 1,612
6,363 7,477
Liabilities total 42,694 41,192
Total 42,804 30,075
STATEMENT OF CHANGES IN SHAREHOLDERS' EQUITY
Attributable to equity holders of the parent company
EUR 1,000 Shares Share Reserve Own Retained Share-
(1000 Capital For Shares Earnings holders'
pcs) invested equity
Un- total
restricted
equityBalance at 89,531 19,850 0 -15 -30,641 -10,807
1.1.2007
Net income/loss -1,726 -1,726
for the period
Options granted 437 437
Share 450 841 841
subscription with
Convertible
capital loans
Share 231 139 139
subscription with
Option rights
681 0 980 0 -1,289 -310
BALANCE AT 90,212 19,850 980 -15 -31,930 -11,117
31.12.2007
Net income/loss -5,477 -5,477
for the period
Options granted 193 193
Share issue 54,109 16,873 16,873
Cost of share -362 -362
issue
54,109 16,511 0 0 -5,285 11,227
BALANCE AT 144,321 36,361 980 -15 -37,215 110
31.12.2008
CASH FLOW STATEMENT
1.1.- 1.1.-
31.12.2008 31.12.2007
EUR 1,000 12 months 12 months
Cash flow from operating Activities
Net income/loss -5,477 -1,726
Adjustments:
Non-cash transactions -4,303 -3,452
Addition/disposal due to 0 -644
revaluation
of financial assets at fair
value through profit or loss
Interest and other 1,863 817
financial expenses
Interest income -1,431 -216
Taxes -76 0
Change in working capital:
Change in accounts receivables and 446 -190
other receivables
Change in accounts payable and -277 96
other liabilities
Change in mandatory provisions -152 10
Interests paid -29 -40
Interests received 66 57
Taxes paid 0 0
Net cash from operating activities -9,370 -5,288
Cash flow from investing activities
Acquisition of subsidiary, net of cash acquired 1,881 0
Change in financial assets at
fair value through profit or loss
Additions 0 -4,500
Disposals 27,685 5,280
Change in investments held to maturity
Additions -46,300 0
Disposals 28,321 0
Investments to tangible assets -34 -23
Net cash used in investing activities 11,553 757
Cash flow from financing activities
Payments from share issue 3,300 139
Share issue costs -362 0
Proceeds from borrowings 1,374 874
Repayment of loans -40 -40
Repayment of lease -21 -23
Commitments
Net cash from financing activities 4,250 950
Net increase (+) or decrease (-) 6,433 -3,581
in cash and cash equivalents
Cash and cash equivalents in the 305 3,886
beginning of the period
Cash and cash equivalents in the 6,738 305
end of the period
Contingent liabilities
EUR 1,000 2008 2007
Operating lease commitments 123 159
Due within a year 64 60
Due later 59 99
Rent commitments 532 652
Due within a year 233 223
Due later 299 429
Total 655 811
The Group leases motor vehicles, machines and equipment with leases
of 3 to 5 years.
Rent commitments include Pharmacity premises until 30 November 2011.
These premises have been subleased until 31 August 2009.
The company has received significant subsidies for several research
projects. In addition, the company has also received capital
investment subsidies. All these subsidies are subject to various
terms and conditions. If these conditions are subsequently not met by
the company, future repayment obligations could arise. The amount and
timing of potential repayments can presently not be estimated.
Currently, the company has no indication that any claims by the
granting authorities will be made.
According to the German employee inventor's law
(Arbeitnehmererfindergesetz), employees based in Germany are eligible
to receive compensation derived from future income related to
intellectual property invented partly or in total by these employees.
This could amount up to a maximum of 2.5% of the income generated by
the respective invention.
The Finnish Act on the Right to Employees' Inventions entitles the
employees in Finland to receive compensation for any of their
inventions belonging under the scope of the Act.
Commitments
On December 31, 2008 Biotie had outstanding purchase obligations,
primarily for contract research work services, totaling EUR 5.6
million.
KEY FIGURES
1.1.- 1.1.-
31.12.2008 31.12.2007
EUR 1,000 12 months 12 months
Business development
Revenues 5,127 7,895
Personnel on average 42 36
Personnel at the end of period 80 37
Research and development costs 8,730 9,053
Capital expenditure 116 287
Profitability
Operating profit/loss -5,121 -1,769
as percentage of revenues, % -99.9 -22.4
Profit/loss before taxes -5,553 -1,726
as percentage of revenues, % -108.3 -21.9
Balance sheet
Cash and cash equivalents 25,238 28,243
Shareholders equity 110 -11,117
Balance sheet total 42,804 30,075
Financial ratios
Return on equity, % - -
Return on capital employed, % -18.3 -7.2
Equity ratio, % 0.3 -37.0
Gearing, % -148,5 40.8
Per share data
Earnings per share (EPS) basic & -0.06 -0.02
diluted, EUR
Shareholders'equity per share, EUR 0.0008 -0.12
Dividend per share, EUR
Pay-out ratio, %
Effective dividend yield, %
P/E-ratio
Share price
Lowest share price, EUR 0.24 0.75
Highest share price, EUR 0.94 1.22
Average share price, EUR 0.51 0.98
End of period share price, EUR 0.26 0.76
Market capitalization 37.5 68.6
at the end of period MEUR
Trading of shares
Number of shares traded 15,350,613 35,093,743
As percentage of all 10.6 38.9
Adjusted weighted average 96,734,553 90,003,192
Number of shares during the period
Adjusted number of shares 144,320,560 90,211,860
at the end of the period
Formulas for the Calculation of the Financial Ratios
Return on capital employed, %
Profit (loss) before taxes + interest expenses and other financial
expenses
--------------------------------------------------------------- x 100
Balance sheet total - non-interest bearing liabilities
Equity ratio, %
Shareholders' equity
--------------------------------------------------------------- x 100
Balance sheet total - advanced received
Gearing, %
Interest bearing liabilities - cash and cash equivalents
-------------------------------------------------------------- x 100
Shareholders' equity
Earnings per share (EPS)
Profit attributable to parent company shareholders
------------------------------------------------------------------
Adjusted average number of outstanding shares during the period
Shareholders' equity per share
Shareholders' equity
------------------------------------------------------------------
Adjusted number of shares at the end of the period
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