BIOTIE THERAPIES CORP. FINANCIAL STATEMENT RELEASE, February 26, 2010 at 9.00
a.m. Finnish time
Biotie Therapies Corp. financial statement release January 1 - December 31, 2009
Key events and financial review during Q4/2009
- In December, Biotie raised EUR 7.2 million through a directed issue of
14,432,000 new shares at a subscription price of EUR 0.50 per share in an
oversubscribed offering.
- In October, Biotie entered into a Standby Equity Distribution Agreement with
US investment fund Yorkville in order to secure the financing of Biotie's
working capital. Under the agreement, Biotie has the option to place Biotie
shares up to a total value of EUR 20 million over a period of 36 months.
- Revenue for October - December amounted to EUR 1.1 million (EUR 1.2 million in
2008).
- The net loss for October - December stood at EUR 4.0 million (net loss of
comparable period in 2008 was EUR 1.7 million). Cash flow from operating
activities in October - December was EUR -4.6 million (EUR -1.5 million for
comparable period in 2008) and earnings per share was EUR -0.03 (EUR -0.01 in
2008).
Key events and financial review for the full year 2009
- In September, Biotie started a clinical study with its phosphodiesterase 4
(PDE4) inhibitor ELB353 with the goal to evaluate the safety, tolerability,
pharmacodynamics and pharmacokinetics of repeated doses of oral ELB353 in up to
48 healthy volunteers. ELB353 is intended to be developed for the treatment of
COPD. Results are expected in the first half of 2010.
- In August, Biotie reached a milestone in its collaboration with Pfizer for the
development of PDE10 (phosphodiesterase 10) inhibitors for schizophrenia,
triggering a USD 1.0 million milestone payment to Biotie.
- In August, the Board of Directors decided to pool capacities and strengthen
the Company's focus on the more advanced key research and development programs
and to terminate the development of certain early R&D programs as a result of
the completion of the integration process with the German subsidiary Biotie
Therapies GmbH.
- In February and March, Biotie initiated two clinical studies in rheumatoid
arthritis and psoriasis patients with its fully human VAP-1 monoclonal antibody.
Results from these studies are expected to become available during the first
half of 2010.
- Revenue for January - December 2009 amounted to EUR 5.6 million (EUR 5.1
million in 2008).
- The net loss for 2009 stood at EUR 12.3 million excluding extraordinary items
in relation to write-offs of certain intangible assets. Total net loss for 2009
including extraordinary items in relation to write-offs of intangible assets was
EUR 16.1 million (net loss for 2008 was EUR 5.5 million; there were no
extraordinary items in 2008) and earnings per share for the period was EUR
-0.11(EUR -0.06 in 2008).
- Cash flow from operating activities in January - December was EUR -13.3
million (EUR -9.4 million for the same period in 2008).
- As of December 31, the company's liquid assets amounted to EUR 19.7 million
(EUR 25.2 million as of December 31, 2008).
Key events after the reporting period
- In January 2010 Biotie reported positive top-line data from clinical study
with VAP-1 monoclonal antibody (BTT-1023) in rheumatoid arthritis patients.
BTT-1023 is well tolerated and shows signals of therapeutic activity.
Future outlook
- During 2010, Biotie will provide support to its license partner Lundbeck for
the ongoing phase III studies with Nalmefene in alcohol dependence, expecting
first results from these trials towards the end of 2010.
- Biotie will continue to perform a clinical study with its proprietary VAP-1
antibody in psoriasis patients. Results of this study will become available in
the second quarter of 2010. The recent completion of the study in rheumatoid
arthritis patients provides Roche with its first opportunity to exercise the
option to license the product. If not exercised, the initial option right will
expire, although Roche may extend it to later development points by paying
additional fees.
- The company will continue to conduct 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. Results are expected in the first
half of 2010.
- In its collaboration with Pfizer on the discovery and development of novel
PDE10 inhibitors for the treatment of psychiatric disorders, Biotie and its
partner intend to identify further development candidates. Although it is
anticipated that the research collaboration could end in 2010, Pfizer would keep
a license to the discovered products during the collaboration and Biotie would
be entitled to milestones and royalties in case of successful development of
these products.
- The future financial result of the company will be highly dependent on the
company´s success in licensing clinical programs to pharmaceutical companies.
More specifically, Roche's decision on their option exercise regarding the VAP-1
product may have a significant impact on the financial situation of Biotie
beyond 2010. However, even in the absence of any additional income, the company
is adequately funded to support its ongoing activities well into 2011.
Timo Veromaa, Biotie's President and CEO:
"2009 has undoubtedly been a cornerstone year for Biotie. We made several
significant clinical advancements to our product portfolio, delivered on various
milestones for our partners, successfully integrated our newly acquired German
subsidiary, completed a successful fundraising, and demonstrated our ability to
exercise fiscal discipline. As a result, we are more focused than ever on
delivering clinical excellence as we drive our core anti-inflammatory and
central nervous system programs further into development."
Webcast and conference call
An analyst and media conference call will be arranged on February 26, 2010
at 1.00 p.m. Finnish time. The conference call will be held in English. The
financial statements will be presented by Biotie's President and CEO Timo
Veromaa.
Callers may access the conference directly at the following telephone numbers:
UK: +44 (0) 203 003 2666, Finland: 0800 914672, no code. Lines are to be
reserved ten minutes before the start of conference call.
For further information, please contact:
Virve Nurmi, IR Manager, tel. +358 2 2748 911
About Biotie Therapies
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.
Current status of clinical and pre-clinical drug development projects
Nalmefene, a new treatment paradigm for 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, thereby controlling and limiting
the intake of alcohol. Nalmefene distinguishes itself by being available as an
oral tablet formulation to be taken on an as needed basis.
Biotie has granted worldwide rights (excluding Korea) for Nalmefene to Lundbeck.
Under the terms of the license agreement, Biotie is eligible for up to EUR 84
million in payments plus royalties on sales. At the end of 2008, Lundbeck
started three clinical phase III trials, which seek to enroll about 1,800
patients in total. Two trials, in which patients are treated over a period of
six months, serve to confirm the efficacy of Nalmefene, whilst the objective of
the third study, in which patients are treated for 12 months, is to assess the
safety and tolerability of the compound. We expect preliminary trial data to
become available towards the end of 2010. Biotie is participating in financing
some of the clinical development costs.
ELB353, an oral PDE4 inhibitor for COPD in clinical development. ELB353 is a
once-daily, oral 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.
ELB353 has been well tolerated in a Phase I single and multiple dosing study,
particularly with respect to central nervous system and gastrointestinal side
effects. Furthermore, blood plasma profiles of ELB353 showing pronounced and
long lasting exposure support once-daily dosing. Biotie is currently conducting
a clinical study with the aim to further evaluate the safety, tolerability,
pharmacodynamics and pharmacokinetics of repeated doses of ELB353 in up to 48
healthy volunteers. The study is expected to provide proof of pharmacodynamic
activity in humans, corroborate the safety profile and establish dose ranges for
further therapeutic studies. Results are expected in the first half of 2010.
VAP-1, a key inflammation receptor. Vascular Adhesion Protein-1 (VAP-1) is
Biotie's proprietary target. VAP-1 has been shown to play a key role in
inflammatory chronic diseases such as rheumatoid arthritis, psoriasis and
diabetes. Potentially it also plays a role in 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
approaches are being pursued by Biotie for various 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. Biotie completed the first-in-man, single dose,
placebo-controlled clinical study with the VAP-1 antibody in 2008. Moreover,
after the reporting period in January 2010 Biotie reported that it has
successfully completed a clinical trial with the product in rheumatoid arthritis
patients, demonstrating the safety, tolerability, and pharmacokinetics of
repeated doses of intravenously administered antibody in 24 rheumatoid arthritis
patients. Although the study was not designed to enable formal statistical
evaluation of therapeutic activity, in several assessments of treatment effect
such as Disease Activity Score based on 28 joint assessment (DAS28) criteria,
American College of Rheumatology (ACR) criteria, physician's global assessment
and erythrocyte sedimentation rate, responses in higher dose groups were greater
than in the placebo group. Several patients receiving higher doses of BTT-1023
reached an ACR50 response (i.e. a 50% reduction in their ACR score) during
treatment.
A similarly designed clinical study initiated in March 2009 in psoriasis
patients is currently ongoing and results from this study are expected in the
second quarter of 2010.
In 2006, Biotie and Roche have signed an option agreement for Biotie's fully
human antibody program targeting VAP-1 in inflammatory disease. Roche has paid
Biotie a EUR 5 million option fee, which grants Roche an option right to an
exclusive, worldwide license agreement for Biotie's VAP-1 antibody, excluding
Japan, Taiwan, Singapore, New Zealand, and Australia. The recent completion of
the study in rheumatoid arthritis patients provides Roche with its first
opportunity to exercise the option. If not exercised, the initial option right
will expire, although Roche may extend it to later development points by paying
additional fees.
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 on sales in the territory. Biotie has already
received USD 2.7 million from Seikagaku.
VAP-1 SSAO inhibitors. Biotie and Roche also collaborate on the development of
small molecule VAP-1 SSAO inhibitors. 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 SSAO enzyme inhibitor in its
territory. If Seikagaku exercises its option, Biotie will receive up to USD
16.7 million in milestone payments plus royalties on 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.
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 is partnered with Pfizer since
December 2006. In August 2009, Biotie reached a milestone in its collaboration
with Pfizer, triggering a USD 1.0 million milestone payment. According to the
agreement with Pfizer, Biotie is eligible for up to USD 110 million in payments
plus royalties on sales. Although it is anticipated that the research
collaboration could end in 2010, the license to Pfizer in respect to the
discovered products during the collaboration would remain in place.
Financial review
Revenues
Revenue for the financial year 2009 amounted to EUR 5.6 million (in the same
period 2008, EUR 5.1 million). Revenue consisted of milestone payment and income
from the ongoing research collaboration with Pfizer as well as periodization of
previously received up-front payments of the licensing agreements the company
has in place with several licensing partners.
In August 2007, the central development agency for the state of Saxony
(Sächsische Aufbaubank, SAB) 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 December 31, 2009, EUR 1.1
million of this grant were still available to the company. The grant covers 65%
of personnel and project related cost, so Biotie Therapies GmbH must show a
total expenditure of EUR 1.8 million until July 2010 in relation to the research
projects in order to benefit from the full amount still available. Payments to
Biotie Therapies GmbH in relation to this grant are reported under other
operating income.
Financial result
The net loss for the financial year 2009 was EUR 12.3 million excluding
extraordinary items in relation to write-offs of intangible assets. Total net
loss for the financial year 2009 including extraordinary items amounted to EUR
16.1 million. The corresponding loss for 2008 was EUR 5.5 million and no
extraordinary items were reported. Research and development costs for the year
2009 amounted to EUR 21.1 million, including extraordinary items (in 2008 EUR
8.7 million).
Impairment losses of EUR 5.4 million were recorded in 2009 due to the decision
of the Board of Directors as of August 6, 2009 to pool capacities for the
development of the more advanced projects and terminating active development of
the immunosuppression program (EUR 1,0 million), termination of the development
of the Buprenorphine Depot product (EUR 2,0 million), termination of the HCV
infection program after the termination of the license agreement with Gilead,
and subsequent winding down of Biotie's wholly owned Belgian subsidiary 4AZA IP
NV (EUR 2.4 million).
Patent costs have been booked as expenses and were not capitalized.
Financing
Cash and cash equivalents totaled EUR 19.7 million on December 31, 2009 (EUR
25.2 million on December 31, 2008).
The company has invested its liquid assets into bank deposits and money market
funds. Bank deposits with maturity more than 3 months are reported in
"investments held to maturity" whereas deposits with maturity less than 3 months
are reported in the "cash and cash equivalents". Money market funds are reported
at fair value in financial assets at fair value through profit or loss.
In September 2009, the company has entered into a Standby Equity Distribution
Agreement with YA Global Master SPV Ltd., a fund managed by Yorkville Advisors,
LLC of Jersey City, New Jersey, USA ("Yorkville"). Under the terms of the
agreement, Biotie has the option to take up Yorkville's commitment to subscribe
and pay for ordinary no-par Biotie shares up to a total value of EUR 20 million
during the period until September 2012. It remains at the sole and exclusive
discretion of Biotie to exercise this option. The pricing of the shares will be
determined as 95% of the lowest daily volume-weighted average share price of the
five trading days following the date on which Biotie shall have sent to
Yorkville the relevant advance notice, and may in no event be less than 85% of
the volume-weighted average price of Biotie shares on NASDAQ OMX Helsinki Ltd.
on the last trading day prior to such date of advance notice.
The purpose of the Standby Equity Distribution Agreement is to have an option to
secure the financing of Biotie's working capital in the short and medium term.
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.
Shareholder's equity
The shareholders' equity of the group amounts to EUR -8.9 million (IFRS).
Biotie's equity ratio was -28.4 % on December 31, 2009 (0.3 % in 2008).
According to Finnish Accounting Standards (FAS), shareholders' equity is less
than half of the parent company's share capital. The parent company's share
capital is EUR 51.5 million; shareholders' equity is EUR 11.5 million and
capital loans stand at EUR 21.3 million. Thus, shareholders' equity plus capital
loans add up to EUR 32.8 million. The company does not have funds that could be
used for profit distribution.
Investments and cash flow
The cash flow from operations was EUR -13.3 million for January - December 2009
(comparable period in 2008 EUR -9.4 million). The group's investments during the
reporting period amounted to EUR 0.5 million (EUR 0.1 million in 2008).
Personnel
During the financial year 2009, the company's personnel had an average of 81
employees (42 in 2008) and at the end of the financial year 82 (80 on December
31, 2008). This increase is mainly due to the inclusion of the German
subsidiary, which was acquired in November 2008.
Changes in management team
On June 1st, Biotie´s Board of Directors appointed Mr. Chris Piggott as Chief
Business Officer and member of the management team of the Company.
Group structure
The parent company of the group is Biotie Therapies Corp. The domicile of the
Company is Turku, Finland. The group has an operating subsidiary, Biotie
Therapies GmbH, located in Radebeul, Germany.
Biotie Therapies GmbH acquired 4AZA IP NV Leuven (Belgium) on March 31, 2009, by
means of exercising an option acquired in November 2008. During Q3 2009, the
company has wound down this non-operating subsidiary, 4AZA IP NV of Leuven,
Belgium. 4AZA IP was a special purpose vehicle whose sole activity was the
holding of certain intellectual property rights, which the company decided to
abandon.
Thegroup also has a non-operational subsidiary named Biotie Therapies
International Ltd in Finland.
Shareholders' meetings held during the financial year 2009
Annual General Meeting 2009
The Annual General Meeting (AGM) of Biotie Therapies Corp. was held on 29 May
2009 and resolved the following items:
- adoption of financial statements 2008
- resolution to carry forward the loss of the financial year to the unrestricted
equity without payment of dividends
- discharge from liability for all members of the Board of Directors and the
Managing Director for the financial year 2008
- election of Juha Jouhki, Ann Hanham, Bernd Kastler, Pauli Marttila, Riku
Rautsola, Christoph Schröder and Pierre Serrure as members of the Board of
Directors
- appointment of PricewaterhouseCoopers Oy, Authorized Public Accountants, and
Janne Rajalahti, Authorized Public Accountant, as auditors of the company.
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.
Juha Jouhki, Christoph Schröder, and Pauli Marttila were elected to the Board's
internal Nomination and Remuneration Committee and Bernd Kastler, Riku Rautsola,
and Piet Serrure were elected to the Audit Committee.
Extraordinary General Meeting held on 29 October 2009
An Extraordinary General Meeting of Biotie Therapies Corp. was held on 29
October 2009 and the following items were resolved:
- increase of number of members of the Board of Directors to eight
- election of Peter Fellner to the Board of Directors
- authorisation to the Board of Directors to decide on the issuance of up to
72,000,000 shares or other instruments entitling to new shares in one or more
issues pursuant to chapter 10 of the Companies Act. The authorisation is
effective until 30 June 2010 and it supersedes all earlier authorisations.
- amendment of the Articles of Association in accordance to the amendment to the
Finnish Companies Act regarding the method and minimum period for publishing the
summons to the general meetings.
Market capitalization and trading
At the end of financial year 2009 the share price was EUR 0.55, the highest
price during the financial year was EUR 0.67, the lowest was EUR 0.23, and the
average price was EUR 0.42. Biotie's market capitalization at the end of
financial year 2009 was EUR 87.3 million.
The trading volume on NASDAQ OMX Helsinki during the financial year 2009 was
51,471,584 shares, corresponding to a turnover of EUR 22.1 million.
In September 2009 Biotie and Nordea Bank Finland Plc concluded a market making
agreement. This agreement aims at increasing the share's liquidity and
decreasing the share price volatility thus facilitating trading.
Option rights
Biotie has issued option rights to certain of its employees pursuant to two
different option programs in 2006 and 2009. The total number of granted options
on December 31, 2009 amounts to 9,768,800, which represents 6.15 % of the total
amount of shares. A previous option program instated in 2004 expired at the end
of 2009. No shares were subscribed pursuant to this program.
Shares and options held by management
At the end of financial year 2009 the amount of company's shares held by the
Board of Directors and the company's management and their controlled companies
amounted to 8,663,032 shares and 7,181,980 option rights of which 1,500,000
options are conditional achieving certain set targets.
Share capital and shares
Biotie shares are all of the same class and have equal rights. Each share
entitles the holder to one vote at the general meeting of shareholders. All
shares are freely transferable and are quoted on NASDAQ OMX Helsinki Ltd (Small
cap, Healthcare).
A total of 14,432,000 new shares were subscribed by Invesco Fund Managers
Limited on 7 December 2009 in connection a directed share issue. The increase of
Biotie's share capital by EUR 7,216,000 was registered with the Trade Register
and the registered new shares were admitted to trading on NASDAQ OMX Helsinki
Ltd as of 14 December 2009.
The new shares entitle to the exercise of the rights belonging to a shareholder
as of the registration date of 14 December 2009.
After the registration of the new shares and the increase of the share capital
with the Finnish Trade Register the share capital in Biotie amounts to EUR
51,506,678.10 (FAS), the total number of shares is 158,752,560 and the number of
votes 158,289,305.
At the end of the financial year 2009 the company had 7,316 shareholders
compared to 6,580 at the end of 2008.
Changes in ownership
During 2009, the company became aware of five notices of change in ownership
exceeding the disclosure threshold.
January 2010 gained knowledge of the notification regarding the change in
holdings relate to the increase in the total number of shares in the Company as
a result of the directed share offering.
Information on notices of change in ownership and a monthly updated list of
Biotie's major shareholders is available on the company's website at
www.biotie.com/investors.
Ten largest shareholders of Biotie on December 31, 2009
Number of shares %
Finnish Innovation Fund (Sitra) 13,585,350 8.58
Veritas Pension Insurance Company Ltd. 6,684,175 4.22
Juha Jouhki and his controlled companies:
- Thominvest Oy (2,937,900)
- Dreadnought Finance Oy (2,098,416)
- Jouhki Juha (1,501,356)
Total: 6,537,672 4.13
Finnish Industry Investment Ltd 4,496,592 2.84
BioFund Ventures III Ky 2,485,715 1.57
Harri Markkula and his controlled companies:
- Markkula Harri (1,250,148)
- Tilator Oy (369,700)
Total: 1,619,848 1.02
elbion NV 1,484,965 0.94
Alfred Berg Small Cap Finland 1,203,008 0.76
Kastler GmbH 1,195,702 0.75
Oy H. Kuningas & Co AB 1,058,371 0.67
----------------------------------------------------------------------
40,351,398 25.49
Other shareholders 44,218,154 27.94
Nominee registered shares total 73,719,753 46.57
-------------------------
158,289,305 100.00
Own shares held by Biotie Therapies 463,255
Total 158,752,560
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 its operations. 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.
Any adverse circumstance in relation to any of its R&D programs might jeopardize
the value of the asset and thus, represent a severe risk to the company. Such
adverse events could happen on a short term notice and are not possible to
foresee.
The key operational risks of Biotie's activities include the dependency on key
personnel, assets (especially assets in relation to intellectual property
rights) and dependency on its license partners' decisions.
Significant financial resources are required to advance the drug development
programs into commercialized pharmaceutical products. To fund the operations,
the group relies on its ability to secure financing from four major sources:
income from its license partners, grant income, loans from TEKES and raising
equity financing in the capital markets.
Entering into commercialization, collaboration and licensing agreements with
larger pharmaceutical companies entitles the company and its subsidiaries to
receive up-front, milestone dependent and royalty payments from these partners.
Although Biotie has currently several active license agreements in place, any
decision by one of its partners to terminate an agreement would have a negative
effect on the short to medium term access to liquidity for the company.
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. Income and loans from
such sources have been secured until 2009. So far, the Company has no indication
that this source of financing will be available beyond 2009.
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. Current capital market conditions are volatile and it is currently
uncertain whether the company can secure equity financing if and when it needs
it from capital markets, even though it was successful at doing so in December
2009.
To protect the continuity of Biotie's operations, sufficient liquidity and
capital has to be maintained in 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 can influence 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.
As a result of the Biotie Therapies GmbH acquisition in November 2008 the Group
has In-process R&D projects totalling EUR 6.5 million included in the balance
sheet. These projects are annually tested for impairment. Should it be required
to recognise impairments due to the impairment testing, it would have a material
effect on the Company's results and balance sheet position.
The Board of Directors proposal for handling of the loss
The Board of Directors proposes that no dividend from the financial year 2009
will be paid, and that the loss of the parent company for the financial year EUR
-10.3 (FAS) million will be carried forward to shareholders' equity.
Annual General Meeting
Biotie's Annual General Meeting will be held at the auditorium of Restaurant
Alabama in Turku on Thursday, April 15, 2010 at 10.00 a.m.
IFRS and accounting principles
The 2009 financial statement release has been prepared in accordance with IFRS
recognition and measurement principles, and applying the same accounting policy
as for the 2008 financial statements. In addition, the changes in the
presentation of statement of comprehensive income and the statement of changes
in equity according to the revised IAS 1 have been applied in the interim
report. The IFRS 8 'operating segments' standard does not have an impact on the
presentation of the Group's financial statements since the Group is operating in
one segment. The interim report has not been prepared in accordance with IAS
34, Interim Financial Reporting.
Financial statements 2009 are not directly comparable to those of the same
period in 2008 due to the inclusion of the operating result of the wholly owned
subsidiary Biotie Therapies GmbH (formerly elbion GmbH) in November 2008.
This financial statement report is audited.
Financial calendar 2010
Year 2009 Annual Report (incl. full financial statements and the report of the
Board of Directors) on March 15, 2010
Interim Report for January - March 2010 on May 7, 2010
Interim Report for January - June 2010 August 6, 2010
Interim Report for January - September 2010 October 29, 2010
Biotie Therapies Corp. will publish its Corporate Governance Statement 2009 on
March 15, 2009 together with the 2009 Annual Report. The statement will be
published separately from the Board of Directors' report and it will be
available after publishing on Biotie's website www.biotie.com
<http://www.biotie.com/>.
In Turku, February 26, 2010
Biotie Therapies Corp.
Board of Directors
For further information, please contact:
Virve Nurmi, Investor Relations Manager
tel. +358 2 274 8900, e-mail: virve.nurmi@biotie.com
<mailto:virve.nurmi@biotie.com>
Distribution:
NASDAQ OMX Helsinki Ltd
Main Media
www.biotie.com
CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME
(IFRS)
1.10.- 1.10.- 1.1.- 1.1.-
31.12.2009 31.12.2008 31.12.2009 31.12.2008
EUR 1,000 3 months 3 months 12 months 12 months
--------------------------------------------------------------------------------
Revenue 1,096 1,177 5,628 5,127
Research and -4,368 -2,454 -21,109 -8,730
development expenses
General and -1,065 -819 -3,768 -2,020
administrative expenses
Other operating income 456 323 1,618 502
--------------------------------------------------------------------------------
Operating profit/loss -3,881 -1,773 -17,631 -5,121
Financial income 56 924 627 1,432
Financial expenses -179 -902 -938 -1,864
--------------------------------------------------------------------------------
Profit/loss before taxes -4,004 -1,751 -17,942 -5,553
Taxes 0 76 1,859 76
--------------------------------------------------------------------------------
Net income/loss -4,004 -1,675 -16,083 -5,477
Total comprehensive income of the -4,004 -1,675 -16,083 -5,477
period
Net income/loss attributable to
Parent company shareholders -4,004 -1,675 -16,083 -5,477
Total comprehensive income
attributable to:
Parent company shareholders -4,004 -1,675 -16,083 -5,477
Earnings per share (EPS) -0.03 -0.01 -0.11 -0.06
basic & diluted, EUR
CONSOLIDATED STATEMENT OF FINANCIAL POSITION
(IFRS)
EUR 1,000 31.12.2009 31.12.2008
------------------------------------------------------------------------
Assets
Non-current assets
Intangible assets 7,186 10,352
Goodwill 379 379
Property, plant and equipment 2,666 2,792
Other shares 10 0
------------------------------------------------------------------------
10,241 13,523
Current assets
Prepaid expenses 0 2,400
Available for sale investment 34 131
Investments held to maturity 0 18,500
Accounts receivables and other receivables 1,507 1,512
Financial assets at fair value through 8,853 0
profit or loss
Cash and cash equivalents 10,891 6,738
------------------------------------------------------------------------
21,285 29,281
Total 31,526 42,804
Equity and liabilities
Shareholders' equity
Share capital 43,057 36,361
Reserve for invested unrestricted equity 1,180 980
Retained earnings -37,092 -31,754
Net income/loss -16,083 -5,477
------------------------------------------------------------------------
Shareholders' equity total -8,938 110
Non-current liabilities
Provisions 160 121
Non-current financial liabilities 25,597 24,930
Pension benefit obligation 543 574
Other non-current liabilities 6,729 5,881
Non-current deferred revenues 1,375 2,966
Deferred tax liabilities 0 1,859
------------------------------------------------------------------------
34,404 36,331
Current liabilities
Provisions 594 641
Pension benefit obligation 17 10
Current financial liabilities 217 144
Current deferred revenues 1,953 3,501
Accounts payable and other current liabilities 3,279 2,067
------------------------------------------------------------------------
6,060 6,363
Liabilities total 40,464 42,694
Total 31,526 42,804
CONSOLIDATED 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
equity
--------------------------------------------------------------------------------
Balance at 1.1.2008 90,212 19,850 980 -15 -31,930 -11,117
--------------------------------------------------------------------------------
Total comprehensive income -5,477 -5,477
for the period
Options granted 193 193
Share issue 54,109 16,873 16,873
Cost of share issue -362 -362
--------------------------------------------------------------------------------
54,109 16,511 0 0 -5,285 11,227
--------------------------------------------------------------------------------
BALANCE AT 144,321 36,361 980 -15 -37,215 110
31.12.2008
--------------------------------------------------------------------------------
Total comprehensive income -16,083 -16,083
for the period
Options granted 339 339
Share issue 14,432 7,216 7,216
Cost of share issue -520 -520
Reissue of own shares 200 -200 0
pursuant to SEDA agreement
--------------------------------------------------------------------------------
14,432 6,696 200 0 -15,944 -9,048
--------------------------------------------------------------------------------
BALANCE AT 158,753 43,057 1,180 -15 -53,160 -8,938
31.12.2009
--------------------------------------------------------------------------------
CONSOLIDATED STATEMENT OF CASH FLOWS
1.1.- 1.1.-
31.12.2009 31.12.2008
EUR 1,000 12 months 12 months
-----------------------------------------------------------------------
Cash flow from operating Activities
Net income/loss -16,083 -5,477
Adjustments:
Non-cash transactions 3,331 -4,303
Addition/disposal due to -53 0
revaluation
of financial assets at fair
value through profit or loss
Interest and other 963 1,863
financial expenses
Interest income -599 -1,431
Taxes -1,859 -76
Change in working capital:
Change in accounts receivables and -126 446
other receivables
Change in accounts payable and 1,172 -277
other liabilities
Change in mandatory provisions -8 -152
Interests paid -106 -29
Interests received 48 66
Taxes paid -6 0
-----------------------------------------------------------------------
Net cash from operating activities -13,326 -9,370
Cash flow from investing activities
Acquisition of subsidiary, net of cash acquired 0 1,881
Change in financial assets at
fair value through profit or loss
Additions -9,000 0
Disposals 200 27,685
Change in investments held to maturity
Additions -900 -46,300
Disposals 20,142 28,321
Investments to tangible assets -165 -34
-----------------------------------------------------------------------
Net cash used in investing activities 10,277 11,553
Cash flow from financing activities
Payments from share issue 7,216 3,300
Share issue costs -520 -362
Proceeds from borrowings 632 1,374
Repayment of loans -40 -40
Repayment of lease -86 -21
Commitments
-----------------------------------------------------------------------
Net cash from financing activities 7,202 4,250
Net increase (+) or decrease (-) 4,153 6,433
in cash and cash equivalents
Cash and cash equivalents in the 6,738 305
beginning of the period
Cash and cash equivalents in the 10,891 6,738
end of the period
Contingent liabilities
EUR 1,000 31.12.2009 31.12.2008
------------------------------------------------------------------------
Operating lease commitments 137 123
Due within a year 88 64
Due later 49 59
Rent commitments 382 532
Due within a year 237 233
Due later 145 299
------------------------------------------------------------------------
Total 519 655
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.
Commitments
On December 31, 2009 Biotie had purchase commitments, primarily for contract
research work services, totaling EUR 6.9 million.
KEY FIGURES
1.1.- 1.1.-
31.12.2009 31.12.2008
EUR 1,000 12 months 12 months
------------------------------------------------------------------
Business development
Revenues 5,628 5,127
Personnel on average 81 42
Personnel at the end of period 82 80
Research and development costs 21,109 8,730
Capital expenditure 475 116
Profitability
Operating profit/loss -17,631 -5,121
as percentage of revenues, % -313.27 -99.9
Profit/loss before taxes -17,942 -5,553
as percentage of revenues, % -318.80 -108.3
Balance sheet
Cash and cash equivalents 19,744 25,238
Shareholders equity -8,938 110
Balance sheet total 31,526 42,804
Financial ratios
Return on equity, % - -
Return on capital employed, % -86.0 -18.3
Equity ratio, % -28.4 0.3
Gearing, % -67.9 -148.5
Per share data
Earnings per share (EPS) basic & -0.11 -0.06
diluted, EUR
Shareholders´equity per share, EUR -0.0563 0.0008
Dividend per share, EUR -
Pay-out ratio, % -
Effective dividend yield, % -
P/E-ratio -
Share price
Lowest share price, EUR 0.23 0.24
Highest share price, EUR 0.67 0.94
Average share price, EUR 0.42 0.51
End of period share price, EUR 0.55 0.26
Market capitalization 87.3 37.5
at the end of period MEUR
Trading of shares
Number of shares traded 51,471,584 15,350,613
As percentage of all 32.4 10.6
Adjusted weighted average 144,992,735 96,734,553
number of shares during the period
Adjusted number of shares 158,752,560 144,320,560
at the end of the period
Formulas for the Calculation of the Key figures
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
[HUG#1388655]
Biotie Therapies Corp. financial statement release January 1 - December 31, 2009
| Source: Biotie Therapies
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