2010-10-29 08:02:00 CEST
2010-10-29 08:03:07 CEST
REGULATED INFORMATION
Biotie Therapies - Interim report (Q1 and Q3)
Biotie Therapies interim report: January - September 30, 2010
BIOTIE THERAPIES CORP. INTERIM REPORT 29 October, 2010 at
9.00 a.m.
Biotie Therapies interim report: January - September 30, 2010
- Today, Biotie announced that it will focus the future business of the company
exclusively on clinical development of nalmefene, ronomilast and VAP-1 antibody
and will implement a restructuring plan leading to annual cost reduction of at
least EUR 4 million and transfer of all operations to its headquarters in
Finland. Biotie expects to have approximately 22 employees going forward.
- As part of the restructuring plan, Biotie will spin-off its site in Radebeul,
Germany in an MBO transaction and will take a minority interest in the spin-off
company, biocrea GmbH ("biocrea"). Thomas Kronbach, Biotie's Chief Scientific
Officer, will leave Biotie to become Managing Director of the new entity, into
which all employees and all pre-clinical assets of Biotie Therapies GmbH
(Biotie's subsidiary in Radebeul, Germany) will be transferred.
- Also as part of the restructuring plan, Biotie will start a company-wide
regulated co-determination process with employees in Finland regarding a
potential reduction of headcount by up to 15 employees; while maintaining core
competencies in clinical development and business operations.
- Today, Biotie announced that relating to the planned re-structuring the
research and option agreement with Roche for the development of small molecule
inhibitors of SSAO (semicarbazide-sensitive amine oxidase) has been terminated
by mutual agreement.
- After the reporting period, on October 15, Biotie reported that it regained
rights from Pfizer to compounds relating to PDE10 inhibition for the treatment
of CNS disorders. This asset will be transferred to the newly created spin-off
company, biocrea.
- On September 14, Biotie reported top-line data from a phase I study with its
fully human VAP-1 monoclonal antibody (BTT-1023) in patients with plaque
psoriasis. BTT-1023 continues to demonstrate favourable safety profile. In
January 2010, Biotie reported positive data from a phase I clinical study with
the VAP-1 antibody in rheumatoid arthritis patients.
- On April 26, Biotie announced positive data from a clinical study with its
oral PDE4 inhibitor in healthy volunteers. Ronomilast (previously known as
ELB353) was well tolerated and showed clear pharmacological activity. Enabling
work for a phase II program has been initiated.
- After the reporting period, on October 25, Biotie reported on an issue of
17,251,371 shares to the company itself without consideration for the purpose of
potentially selling such shares to Yorkville pursuant to the terms of the
standby equity distribution agreement ("SEDA") in place. No decision on an offer
to sell treasury shares to Yorkville has been made yet. A prospectus concerning
Biotie's issue of shares to the company itself has been published on that day.
- On August 26, Biotie reported a directed issue of shares pursuant to the SEDA,
offering 114,233 treasury shares to Yorkville against cash payment of EUR
50,000 at a subscription price of EUR 0.44.
- Due to the potential implementation of restructuring plan to focus on clinical
development, income statement and cash flow items as well as assets and
liabilities related to company´s pre-clinical development have been separated as
assets held for sale and discontinued operations
- Revenues for continuing operations in January - September amounted to EUR 1.5
million (EUR 2.5 million in 2009), and EUR 1.0 million for the discontinued
operations (EUR 2.0 million in 2009). Net loss for continuing operations in
January - September was EUR 6.0 million (EUR 5.7 million in 2009). Net loss for
discontinued operations in January - September excluding extraordinary items in
relation to write-offs of intangible assets and goodwill was EUR 4.1 million
(EUR 2.6 million in 2009). Net loss for discontinued operations in January-
September 2010 including extraordinary items in relation to write-offs of
intangible assets was EUR 7.0 million (EUR 6.4 million in 2009). Basic earnings
per share amounted to EUR -0.04 for the continuing operations (EUR -0.04 for
2009) and EUR -0.04 for the discontinued operations (EUR -0.04 for 2009).
- Cash flow from operations in January - September amounted to EUR -7.1 million
for the continuing operations (EUR -6.7 million in 2009) and EUR -3.4 million
for the discontinued operations (EUR -2.1 million in 2009). As of 30 September,
liquid assets amounted to EUR 8.9 million (EUR 16.7 million as of 30 September
2009).
Q3/2010 in brief:
- Revenues for July - September, 2010 amounted to EUR 0.5 million, all from
continuing operations. Revenues for the comparable period in 2009 amounted to
EUR 0.7 million for continuing operations and EUR 1.1 million for discontinued
operations. The net loss for continuing operations in July - September was EUR
1.4 million (EUR 2.0 million in 2009). Net loss for discontinued operations
excluding extraordinary items in relation to write-offs of certain intangible
assets and goodwill was EUR 1.6 million (EUR 0.5 million in 2009). Net loss for
discontinued operations in July - September including extraordinary items
amounted to EUR 4.5 million (EUR 0.5 million in 2009). Basic earnings per share
for July - September amounted to EUR -0.01 for the continuing operations
(EUR ‑0.01 in 2009) and EUR -0.03 for the discontinued operations (EUR 0.00 in
2009).
- Cash flow from operating activities in July - September was EUR -2.4 million
(EUR -2.1 million during July - September 2009).
Timo Veromaa, Biotie's President and CEO:"We are confident that the steps we would be taking today would allow us to
focus on our core competencies and to efficiently advance our existing clinical
pipeline. We also believe to be better positioned to secure additional funding
from capital markets in the future, either by making use of the SEDA in place
with Yorkville or otherwise. The resulting streamlined organization and
corporate structure would enable us to build a stronger clinical pipeline and
additionally consider other strategic options to deliver longer-term sustainable
growth going forward. We look forward to the upcoming results from the ongoing
phase III trials of nalmefene in alcohol dependence and remain enthusiastic
about the differentiated profile of our oral PDE-4 inhibitor, ronomilast, and by
the broad potential of our VAP-1 antibody for the treatment of inflammatory
disorders".
Outlook for 2010
- Biotie will continue to support its licensing partner Lundbeck in the
development of nalmefene for the treatment of alcohol dependence. Phase III
clinical data from the ongoing studies is expected towards the end of 2010; a
possible marketing authorization submission in the EU is anticipated in 2011.
- Biotie will continue with the development of its proprietary VAP-1 antibody.
While the rights to the product in Japan, Taiwan, Singapore, Australia and New
Zealand have been granted to Seikagaku, Biotie retains ownership in the rest of
the world and will be looking for additional collaboration opportunities.
- Biotie intends to continue active development of ronomilast for the treatment
of COPD. Further clinical trials are planned and Biotie will be looking for
potential collaboration opportunities for this product.
- Biotie will need to secure its working capital beyond Q2 2011 in order to
execute its intended product development activities. Income generated from
commercial agreements relating to Biotie's clinical programs may significantly
improve the company's financial position, but no reliable forecast on any
potential income from such commercial agreements can be provided. Biotie may
therefore need to secure additional financing through the issue of shares,
either by exercising its existing SEDA with Yorkville or through share issues to
others.
- The measures in connection to the restructuring plan will accelerate cash
outflows in 2010 due to one-time payments in the amount of approx. EUR 2.5-3
million. Additional cash outflows of approx EUR 2-2.5 million will take place in
future periods in connection with the restructuring plan.
Financial calendar 2011
Next financial report
Biotie's financial statement release 2010 will be published on February
25, 2011.
Conference call
An analyst and media conference call will take place on October 29, 2010 at
2.00 p.m. Central European Time. The conference call will be held in English.
The interim report will be presented by Biotie's President and CEO Timo Veromaa
and CFO Thomas Taapken.
Callers may access the conference directly at the following telephone numbers:
US: +1 212 444 0894, UK: +44 (0)20 7138 0825 and Finland: +358 (0)9 2319 4344
access code 4085851. Lines are to be reserved ten minutes before the start of
conference call. The event can also be viewed as a live webcast
atwww.biotie.com. An on demand version of the conference will be published on
Biotie´s website later during the day. In case you need additional information
or assistance, please contact: Virve Nurmi, IR Manager Biotie Therapies, Tel
+358 2 2748 911
_______________________________________________________________________________
Biotie Therapies detailed interim report
About Biotie
Biotie is a specialized drug development company focused on central nervous
system and inflammatory diseases. It has several innovative small molecule and
biological drug candidates at different stages of clinical development. Biotie's
products address diseases with high unmet medical need and significant market
potential, including addiction and a broad range of inflammatory conditions like
rheumatoid arthritis or chronic obstructive pulmonary disease (COPD). The most
advanced product, nalmefene for alcohol dependence, is currently in phase III
clinical development by licensing partner H. Lundbeck A/S.
Drug development projects and operations:
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 for Nalmefene to Lundbeck. Currently,
Lundbeck is undertaking three phase 3 clinical trials with Nalmefene for the
treatment of alcohol dependence. We expect top-line data from two of the ongoing
clinical trials to become available towards the end of 2010. Biotie is
participating in financing some of the clinical development costs.
Ronomilast, an oral PDE4 inhibitor for COPD in clinical development. Ronomilast
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 respiratory disorder with major unmet
medical need.
In clinical studies with 84 study subjects ronomilast has been demonstrated to
be safe and well tolerated at all tested doses up to 100mg once daily. No
serious or severe adverse events were reported in any of the study subjects.
Robust and statistically highly significant biomarker responses confirmed the
pharmacological activity of well tolerated doses of ronomilast in man. Further
clinical trials are planned and Biotie will be looking for potential
collaboration opportunities for this product.
Vascular Adhesion Protein-1 (VAP-1), a key inflammation receptor. VAP-1 has been
shown to play a key role in inflammatory chronic diseases such as COPD,
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. Biotie has a vast knowledge and strong intellectual property position
around this target.
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 previously reported that it has successfully completed a
clinical trial with its VAP-1 antibody (BTT-1023) in rheumatoid arthritis
patients, demonstrating the safety, tolerability, and pharmacokinetics of
repeated doses of intravenously administered antibody in 24 rheumatoid arthritis
patients who unresponsive to methotrexate therapy. 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 the 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 whereas none of the
placebo patients reached an ACR50 response.
In September, Biotie reported top-line data from a phase I study with VAP-1
antibody in patients with plaque psoriasis in which study the product continues
to demonstrate a favourable safety profile. The study evaluated the safety,
tolerability, and pharmacokinetics of repeated doses of intravenously
administered antibody in 26 patients with active plaque psoriasis. The antibody,
administered at repeated doses of up to 8 mg/kg, was generally well tolerated,
and the pharmacokinetic characteristics of BTT-1023 in psoriasis patients were
consistent with those observed in a previously completed study in rheumatoid
arthritis (RA) patients. The study was not designed to enable formal statistical
evaluation of therapeutic activity. However, whereas no change in disease
activity was noted during the treatment period in any patient receiving placebo,
several patients on active drug experienced an improvement in their condition,
reflected as decreases in their Psoriasis Area Severity Index (PASI) scores and
physicians' clinical assessments. No PASI50 responses (50% decrease in PASI
score) were observed within the relatively short treatment period. Two patients
on active drug were reported to have experienced a transient exacerbation of
their psoriasis symptoms that occurred after the treatment had been completed;
apart from these two cases, no serious or severe adverse events were reported in
the study subjects.
Biotie has granted a license to Seikagaku Corporation for the commercial rights
to the product in 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 is committed to continuing development of its VAP-1 antibody and
preparatory activities towards the start of phase 2 studies are underway. If
deemed necessary and if commercially attractive terms can be achieved, Biotie
will seek development and commercial partners in addition to Seikagaku.
VAP-1 SSAO inhibitors. This research program is currently at the pre-clinical
stage. Biotie announced today that the research and option agreement with Roche
for the development of small molecule inhibitors of SSAO has been terminated by
mutual agreement enabling the company now to seek alternative ways to monetize
this asset, such as asset sale or transfer of the technology.
Biotie's option agreement with Seikagaku Corporation regarding the SSAO
inhibitor program for Japan, Taiwan, Singapore, Australia and New Zealand
remains in force. Biotie could receive up to $16.7 MM from a license agreement
and would be eligible for royalties on future sales in the territory if
Seikagaku exercises its option.
Financial review
On October 25 Biotie issued a restatement of its Q2 2010 interim report in which
it corrected interpretation used in previous interim reports for the year 2010,
according to which grants received from Sächsische Aufbaubank ("SAB") by its
German subsidiary Biotie Therapies GmbH have been recognized as revenue.
Pursuant to the corrected interpretation, the grants shall be recognized as
other operating income. The figures published in this interim report are in line
with the accounting treatment applied in the restated interim report and in
previous years.
Revenues: Revenues for continuing operations in January - September amounted to
EUR 1.5 million (EUR 2.5 million in 2009), and EUR 1.0 million for the
discontinued operations (EUR 2.0 million in 2009). Revenues consisted of income
from the research collaboration with Pfizer and periodization of previously
received up-front payments from licensing agreements that the company has in
place with several licensing partners.
Financial result: Net loss for continuing operations in January - September was
EUR 6.0 million (EUR 5.7 million in 2009) and net loss for for discontinued
operations including extraordinary items in relation to write-offs of
intangible assets and goodwill was EUR 7.0 million (EUR 6.4 million in 2009).
Research and development costs for the reporting period amounted to EUR 10.1
million (Research and development costs for the comparable period in 2009
amounted to EUR 11.3 million, excluding extraordinary items).
Financing: Cash and cash equivalents totaled EUR 8.9 million on September 30
(EUR 16.7 million on 30 September, 2009).
The company has invested its liquid assets into bank deposits. 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".
Biotie has a standby equity distribution agreement (SEDA) with US fund Yorkville
in place. Yorkville is obliged 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 at Biotie's discretion (Biotie option). The purpose of this arrangement is
to have an option to secure the financing of Biotie's working capital in the
short and medium term. Biotie has made use of this arrangement the first time in
August 2010.
Shareholder's equity: The shareholders' equity of the group amounts to EUR -21.9
million (IFRS). Biotie's equity ratio was -127.5% on 30 September 2010 (-41.0%
on 30 September 2009).
Investments and cash flow: Cash flow from operations was EUR -10.5 million for
January - September (EUR -8.8 million during January - September 2009). The
group's investments during the reporting period amounted to EUR 264 thousand
(EUR 426 thousand in 2009).
Personnel
During the reporting period January - September 2010, the company´s personnel
average was 82 (81 during January - September, 2009) and at the end of the
reporting period it was 81 (83 on 30 September, 2009) before the announced of
restructuring plan including the spin-off of the German operations. Following
the spin-off in Germany and execution of planned restructuring measures in
Finland, Biotie expects its total number of employees going forward would be
approximately 22.
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).
Biotie´s share capital (registered on October 12, 2010) is EUR 51,556,678.10
(FAS), the total number of shares is 176,003,931. Of these shares, 17,600,393
are owned by Biotie Therapies Corp.
On August 26, Biotie reported a directed issue of shares pursuant to the SEDA ,
offering 114,233 treasury shares to Yorkville against cash payment of EUR
50,000 at a subscription price of EUR 0.44. The offer was made in order to
strengthen Biotie's working capital and to provide further financing for the
company's R&D programs.
The subscription price of the new shares was registered in its entirety to the
share capital of Biotie.
After the reporting period, on October 25, Biotie reported on an issue of
17,251,371 shares to itself without consideration for the purpose of potentially
selling such shares to Yorkville pursuant to the terms of the standby equity
distribution agreement ("SEDA") in place. No decision on an offer to sell
treasury shares to Yorkville has been made yet. If sold, the company will use
these proceeds to secure financing of the company's working capital in the short
and medium term. A prospectus concerning Biotie's issue of shares to the company
itself has been published on that day.
All shares were issued pursuant to the authorisation by the General Meeting of
Shareholders of Biotie held on 15 April 2010.
Changes in ownership
From July to September 2010, Biotie made one announcement on 11 August according
to Chapter 2, Section 10 of the Finnish Securities Market Act.
Information on notices of changes in ownership and a monthly updated list of
Biotie's major shareholders is available on the company's website at
www.biotie.com/investors.
Short-term risks and uncertainties
Biotie's strategic risks are predominantly related to the technical success of
the drug development programs, regulatory issues, strategic decisions of its
commercial partners, ability to obtain and maintain intellectual property rights
for its products, launch of competitive products and the development of the
sales of its products. The development and success of Biotie's products depends
to a large extent on third parties. Any adverse circumstance in relation to any
of its R&D programs might impair 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 in relation to intellectual property rights) and
dependency on its license partners' decisions.
Furthermore, significant financial resources are required to advance the drug
development programs into commercialized pharmaceutical products. To fund the
operations, Biotie relies on financing from three major sources: income from its
license partners, grant income and raising equity financing in the capital
markets.
Although Biotie has currently active license agreements in place, the
termination of any such agreement would have a negative effect on the short to
medium term access to liquidity for the company. Grants have been historically
available to Biotie at substantial levels. Availability of grants in the future
cannot be guaranteed and this thus poses a potential risk to the income
situation of the group in the future. Currently ongoing grant programs are
available until Q3 2010. The company relies on capital markets to raise equity
financing from time to time. There can be no assurance that sufficient funds 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.
To protect the continuity of Biotie's operations, it will need to secure its
working capital beyond Q2 2011 in order to execute its intended product
development activities. Although income generated from commercial agreements
with third parties relating to its clinical programs might significantly improve
its financial position, a forecast on possible income from future licensing
arrangements cannot be provided reliably. Therefore it is possible that Biotie
will need to secure additional financing from share issues, either through
exercise of its existing SEDA with Yorkville or through share issues in the
future.
The group can influence the amount of capital used in its operations by adapting
its cost base according to the financing available. The restructuring measures
announced today highlight such an approach. 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.
IFRS and accounting principles
This interim financial report has been prepared in accordance with IFRS
recognition and measurement principles, and applying the same accounting policy
as for the 2009 financial statements. The interim report has not been prepared
in accordance with IAS 34, Interim Financial Reporting.
Assets are classified as held-for-sale according to IFRS 5. Non-current assets
and discontinued operations are classified as held-for-sale and stated at the
lower of carrying value and the fair value less cost to sell, if their carrying
value is recovered principally through a sale transaction rather than through a
continuing use.
A discontinued operation results from the management's decision and commitment
to dispose of a separate business for which the related assets, liabilities and
operating results can be distinguished both operationally and for financial
reporting purposes. When specific criteria for the held-for-sale classification
has been met, the non-current assets are recorded at the lower of carrying value
or fair value less cost to sell, and non-current assets subject to depreciation
or amortization are no longer amortized. The assets and liabilities of a
disposal group classified as held-for-sale are presented in the balance sheet
separate from assets and liabilities related to continuing operations as of the
date the operation qualified as discontinued. The results of discontinued
operations, net of taxes and the gain or loss on their disposal are presented
for all periods separate from continuing operations in the consolidated
statements of income. Balance sheet data from periods preceding the qualifying
disposal decision is not reclassified.
This interim report is unaudited.
Turku, October 29, 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
Distribution:
NASDAQ OMX Helsinki Ltd
Main media
www.biotie.com
CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME (IFRS)
1.7.- 1.7.- 1.1.- 1.1.- 1.1.-
30.9.2010 30.9.2009 30.9.2010 30.9.2009 31.12.2009
EUR 1,000 3 months 3 months 9 months 9 months 12 months
--------------------------------------------------------------------------------
Continuing operations
Revenue 473 660 1,482 2,478 3,138
Research and -963 -1,920 -4,381 -5,624 -7,745
development expenses
General and -784 -713 -2,713 -2,377 -3,434
administrative expenses
Other operating income 41 11 125 25 242
--------------------------------------------------------------------------------
Operating profit/loss -1,233 -1,962 -5,487 -5,498 -7,799
Financial income 24 125 89 562 611
Financial expenses -207 -207 -615 -727 -932
--------------------------------------------------------------------------------
Profit/loss before taxes -1,416 -2,044 -6,013 -5,663 -8,120
--------------------------------------------------------------------------------
Net income/loss, continuing -1,416 -2,044 -6,013 -5,663 -8,120
operations
--------------------------------------------------------------------------------
Discontinued operations
Net income/loss, discontinued -4,504 -472 -7,000 -6,416 -7,963
operations
--------------------------------------------------------------------------------
Net income/loss -5,920 -2,516 -13,013 -12,079 -16,083
Total comprehensive income of -5,920 -2,516 -13,013 -12,079 -16,083
the period
Net income/loss attributable
to
Parent company shareholders -5,920 -2,516 -13,013 -12,079 -16,083
Total comprehensive income
attributable to:
Parent company shareholders -5,920 -2,516 -13,013 -12,079 -16,083
Earnings per share (EPS) -0,01 -0.01 -0,04 -0.04 -0.06
basic & diluted, EUR,
continuing operations
Earnings per share (EPS) -0,03 0.00 -0,04 -0.04 -0.06
basic & diluted, EUR, discontinued operations
CONSOLIDATED STATEMENT OF FINANCIAL POSITION
(IFRS) EUR 1,000
30.9.2010 30.9.2009 31.12.2009
--------------------------------------------------------------------------------
Assets
Non-current assets
Intangible assets 4,055 7,194 7,186
Goodwill 0 379 379
Property, plant and equipment 1,939 2,782 2,666
Other shares 10 10 10
--------------------------------------------------------------------------------
6,004 10,365 10,241
Current assets
Prepaid expenses 77 0 0
Available for sale investment 34 131 34
Investments held to maturity 3,000 6,000 0
Accounts receivables and other receivables 1,036 1,642 1,507
Financial assets at fair value through 0 3,028 8,853
profit or loss
Cash and cash equivalents 5,924 7,673 10,891
Non-current assets classified as held for sale 1,104 0 0
--------------------------------------------------------------------------------
11,175 18,474 21,285
Total 17,179 28,839 31,526
Equity and liabilities
Shareholders' equity
Share capital 42,925 36,361 43,057
Share issue 50 0 0
Reserve for invested unrestricted equity 1,180 980 1,180
Retained earnings -53,051 -37,073 -37,092
Net income/loss -13,013 -12,079 -16,083
--------------------------------------------------------------------------------
Shareholders' equity total -21,909 -11,811 -8,938
Non-current liabilities
Provisions 4 143 160
Non-current financial liabilities 25,657 25,431 25,597
Pension benefit obligation 0 593 543
Other non-current liabilities 7,258 6,544 6,729
Non-current deferred revenues 399 1,849 1,375
--------------------------------------------------------------------------------
33,318 34,560 34,404
Current liabilities
Provisions 591 607 594
Pension benefit obligation 0 17 17
Current financial liabilities 171 209 217
Current deferred revenues 1,448 2,140 1,953
Accounts payable and other current liabilities 2,456 3,117 3,279
Liabilities associated with assets classified as 1,104 0 0
held for sale
--------------------------------------------------------------------------------
5,770 6,090 6,060
Liabilities total 39,088 40,650 40,464
Total 17,179 28,839 31,526
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 1.1.2009 144,321 36,361 980 -15 -37,215 110
--------------------------------------------------------------------------------
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 31.12.2009 158,753 43,057 1,180 -15 -53,160 -8,938
--------------------------------------------------------------------------------
Total comprehensive income -13,013 -13,013
for the period
Options granted 120 120
SEDA costs 4 4
Share issue 50
Cost of share issue -132 -132
--------------------------------------------------------------------------------
0 -132 0 0 -12,889 -12,971
--------------------------------------------------------------------------------
BALANCE AT 30.9.2010 158,753 42,925 1,180 -15 -66,049 -21,909
--------------------------------------------------------------------------------
CONSOLIDATED STATEMENT OF CASH FLOWS
1.1.- 1.1.- 1.1.-
30.9.2010 30.9.2009 31.12.2009
EUR 1,000 9 months 9 months 12 months
--------------------------------------------------------------------------------
Cash flow from operating activities
Continuing operations
Net income/loss -6,013 -5,663 -8,120
Adjustments:
Non-cash transactions -1,154 -2,135 -2,654
Addition/disposal due to revaluation of 0 -28 -53
financial assets
at fair value through profit or loss
Interest and other financial expenses 612 727 931
Interest income -117 -577 -582
Change in working capital:
Change in accounts receivables and other -158 157 280
receivables
Change in accounts payable and other -255 428 527
liabilities
Change in mandatory provisions -18 40 34
Interests paid -31 -59 -74
Interests received 56 420 31
--------------------------------------------------------------------------------
Net cash from operating activities, continuing -7,078 -6,691 -9,681
operations
Net cash from operating activities, discontinued -3,444 -2,066 -3,645
operations
--------------------------------------------------------------------------------
Net cash from operating activities -10,522 -8,757 -13,326
Cash flow from investing activities
Continuing operations
Change in financial assets at fair value through
profit or loss
Additions 0 -3,000 -9,000
Disposals 8,886 0 200
Change in investments held to maturity
Additions -3,000 -900 -900
Disposals 0 13,400 20,142
Investments to tangible assets -53 -29 -35
--------------------------------------------------------------------------------
Net cash used in investing activities, continuing 5,834 9,471 10,406
operations
Net cash used in investing activities, -211 -87 -130
discontinued operations
--------------------------------------------------------------------------------
Net cash used in investing activities 5,623 9,384 10,277
Cash flow from financing activities
Continuing operations
Payments from share issue 50 0 7,216
Share issue costs -132 0 -520
Proceeds from borrowings 6 232 231
Repayment of loans -40 -40 -40
Repayment of lease commitments -132 -72 -86
--------------------------------------------------------------------------------
Net cash from financing activities, continuing -248 120 6,801
operations
Net cash from financing activities, discontinued 180 189 401
operations
--------------------------------------------------------------------------------
Net cash from financing activities -68 309 7,202
Net increase (+) or decrease (-) -4,967 936 4,153
in cash and cash equivalents
Cash and cash equivalents in the 10,891 6,738 6,738
beginning of the period
Cash and cash equivalents in the 5,924 7,673 10,891
end of the period
DiSCONTINUED OPERATIONS
On 28 October 2010, the board resolved to dispose of the Group's pre-clinical
operations in Germany and in Turku. These operations which are expected to be
sold in the near future have been classified as a disposal group held for sale
and presented separately in the balance sheet. The proceeds of disposal are
expected to be less than the book value of the related net assets and
accordingly an impairment loss of EUR 2.9 million has been recognised on the
classification of these operations as held for sale. The results of this
business are reported within discontinued operations.
The results of the discontinued operations as described above which have been
included in the consolidated income statements are as follows:
1.1- 1.1-30.9.2009 1.1-31.12.2009
EUR 1,000 30.9.2010
-----------------------------------------------------------------------------
Result for discontinued operations
Income from ordinary operations 2,065 3,241 3,882
Expenses -6,190 -11,516 -13,704
Result before taxes -4,125 -8,252 -9,822
Taxes 0 1,859 1,859
Result after taxes -4,125 -6,416 -7,963
Earnings due to discontinuation -2,875 0 0
-----------------------------------------------------------------------------
Result for discontinued operations -7,000 -6,416 -7,963
EUR 1,000 30.9.2010
-----------------------------------------------------------------------------
Assets held for sale
Intangible assets 603
Tangible assets 501
Total assets 1,104
Liabilities held for sale
Pension benefit obligations 576
Provisions 306
Other liabilities and accrued expenses 222
Total liabilities 1,104
Contingent liabilities
EUR 1,000 30.9.2010 30.9.2009 31.12.2009
----------------------------------------------------------
Operating lease commitments 124 124 137
Due within a year 81 81 88
Due later 43 43 49
Rent commitments 264 415 382
Due within a year 238 233 237
Due later 26 182 145
----------------------------------------------------------
Total 388 539 519
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 September 30, 2010 Biotie had purchase commitments, primarily for contract
research work services, totaling EUR 2.3 million.
KEY FIGURES
Incl. both continuing and discontinued 1.1.- 1.1.- 1.1.-
operations 30.9.2010 30.9.2009 31.12.2009
EUR 1,000 9 months 9 months 12 months
--------------------------------------------------------------------------------
Business development
Revenues 2,455 4,532 5,628
Personnel on average 82 81 81
Personnel at the end of period 81 83 82
Research and development costs 10,148 16,741 21,109
Capital expenditure 264 426 475
Profitability
Operating profit/loss -9,587 -13,750 -17,631
as percentage of revenues, % -390.5 -303.4 -313.27
Profit/loss before taxes -13,013 -13,938 -17,942
as percentage of revenues, % -530.1 -307.5 -318.80
Balance sheet
Cash and cash equivalents 8,924 16,701 19,744
Shareholders equity -21,909 -11,811 -8,938
Balance sheet total 17,179 28,839 31,526
Financial ratios
Return on equity, % - - -
Return on capital employed, % -131.3 -71.9 -86.0
Equity ratio, % -127.5 -41.0 -28.4
Gearing, % -77,2 -75.7 -67.9
Per share data
Earnings per share (EPS) basic & -0.08 -0.08 -0.11
diluted, EUR
Shareholders´equity per share, EUR -0.14 -0.08 -0.0563
Dividend per share, EUR -
Pay-out ratio, % -
Effective dividend yield, % -
P/E-ratio -
Share price
Lowest share price, EUR 0.41 0.23 0.23
Highest share price, EUR 0.65 0.67 0.67
Average share price, EUR 0.53 0.38 0.42
End of period share price, EUR 0.44 0.58 0.55
Market capitalization 69.9 83.7 87.3
at the end of period MEUR
Trading of shares
Number of shares traded 49,462,429 29,903,949 51,471,584
As percentage of all 31.2 20.7 32.4
Adjusted weighted average 158,752,560 144,320,560 144,992,735
number of shares during the period
Adjusted number of shares 158,752,560 144,320,560 158,752,560
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#1456968]
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