2011-11-04 08:00:00 CET
2011-11-04 08:00:57 CET
REGULATED INFORMATION
Biotie Therapies - Interim report (Q1 and Q3)
Biotie Therapies Corp. Interim report 1 January - 30 September 2011
BIOTIE THERAPIES CORP. INTERIM REPORT 4 November 2011 at 9.00 a.m.
Biotie Therapies Corp. Interim report 1 January - 30 September 2011
Building critical mass through M&A, internal and partnered pipeline advancing
and additional cash resources secured. Biotie has strengthened its business
significantly in the last nine months. In February, Biotie acquired Synosia
Therapeutics, a drug development specialist with key operations in the US,
broadening its pipeline and adding mid-stage novel CNS products. Earlier in the
year Biotie's partner Lundbeck reported positive data from the Phase 3 program
for nalmefene in alcohol dependence and plans to file the drug in Europe by the
end of 2011. In addition, Biotie advanced its own pipeline and in April
announced the start of a Phase 2b study with SYN115 in Parkinson's disease and
in July, the start of a Phase 1 positron emission tomography (PET) imaging study
with SYN120, a potential treatment for cognitive disorders including Alzheimer's
and schizophrenia. Results from an exploratory Phase 2a study of its HPPD
inhibitor SYN118 in Parkinson's disease (PD) were reported in May. These data
did not show a significant improvement in measures of PD motor function when
compared to placebo. Based on the uncertainty of UCB Pharma exercising its
licensing option or further internal development Biotie has fully impaired the
carrying value of this asset. In March, Biotie raised EUR 27 million in a
directed share issue to institutional and strategic investors, strengthening its
financial position.
Financial review for January - September 2011
Financial statements for January - September 2011 are not directly comparable to
the same period in 2010 due to the Synosia Therapeutics acquisition and the
consolidation of the new subsidiaries' results into the Biotie group's
consolidated financial statements from the acquisition date of 1 February 2011
onwards.
Biotie corrected on July 28, 2011 the comparison figures of the interim report
for the period of January - March 2010. The correction affected comparison
figures for January - March 2010, it did not affect the figures reported for
January - March 2011. The comparison figures for the period January - September
2010 have been classified according to IFRS 5.
EUR thousand 1.1. - 1.1. -
30.9.2011 30.9.2010
Continuing operations 9 months 9 months
-------------------------------------------------------
Revenues 977 1,482
Financial result (net loss): -28,506 -6,013
Basic earnings per share (EUR) -0.08 -0.04
Cash flow from operating activities -14,328 -7,078
Investments in tangible assets 36 53
30.9.2011 30.9.2010
------------------------------------
Liquid assets 37,244 8,924
Equity 74,105 -21,909
Equity ratio (%) 61.8 -127.5
Q3/2011 in brief:
Advancement of clinical program for SYN120: Biotie announced in July the start
of a Phase 1 clinical study using positron emission tomography (PET) imaging to
investigate brain concentrations of SYN120, a potential treatment for cognitive
disorders including Alzheimer's disease and schizophrenia.
Proposal and subsequent termination of agreement to acquire Newron
Pharmaceuticals S.p.A.: On 27 September 2011, Biotie and Newron Pharmaceuticals
("Newron") signed a joint merger plan ("Merger Plan") together with a
combination agreement for Biotie to acquire Newron through a European Union
cross-border merger (the "Transaction"). Biotie terminated the agreement on 28
October 2011 due to development described below in Key events after the
reporting period.
Financial review Q3 2011:
Financial statements for Q3 2011 are not directly comparable to the same period
in 2010 due to the Synosia Therapeutics acquisition and the consolidation of the
new subsidiaries' results into the Biotie group's consolidated financial
statements from the acquisition date of 1 February 2011 onwards.
EUR thousand 1.7. - 1.7.-
30.9.2011 30.9.2010
Continuing operations 3 months 3 months
-------------------------------------------------------
Revenues 31 473
Financial result (net loss): -16,185 -1,416
Basic earnings per share (EUR) -0.04 -0.01
Cash flow from operating activities -3,808 -1,593
Financial result for Q3 2011 has been impacted by a non-cash impairment charge
of EUR 11.7 million for SYN118 arising from the uncertainty and likelihood of
UCB exercising its licensing option or further internal development of this
product. The Company has issued a separate stock exchange release relating to
the non-cash impairment charge of SYN118.
Timo Veromaa, Biotie's President and CEO:"As we look ahead, our lead product nalmefene is due to be filed in Europe by
Lundbeck before the end of the year and our pipeline of novel products in CNS
and inflammation is advancing on track. Although the proposed Newron acquisition
did not work out as we had originally thought, we will continue to consider
opportunities for strategic growth. Overall, we believe the company is in great
shape."
Key events after the reporting period
Proposal and subsequent termination of agreement to acquire Newron
Pharmaceuticals S.p.A.: On 27 September 2011, Biotie and Newron Pharmaceuticals
("Newron") signed a joint merger plan together with a combination agreement for
Biotie to acquire Newron through a European Union cross-border merger.
After the reporting period on 21 October 2011, Biotie announced that, effective
April 2012, Merck Serono will return to Newron the full global rights for
safinamide, Newron's lead asset which is currently in Phase 3 development for
Parkinson's disease.
After reviewing this development, the Board of Directors of Biotie notified
Newron of its decision to exercise its right to terminate the current merger
plan and combination agreement, without any further obligations from Biotie. As
a result, Biotie is entitled to a break-up fee of EUR 1.5 million from Newron.
Outlook for 2011 and key pipeline newsflow
* Nalmefene: An orally administered opioid receptor antagonist that completed
Phase 3 development in Q2 2011 for the treatment of alcohol dependence.
Biotie's development and commercialization partner H. Lundbeck A/S
(Lundbeck) is expected to file a marketing authorization application (MAA)
in Europe by year end 2011.
* SYN115 (tozadenant): An orally administered, potent and selective inhibitor
of the adenosine 2a (A2a) receptor in Phase 2b development for the treatment
of Parkinson's disease. Biotie has granted a worldwide license to UCB Pharma
for the development of the compound through Phase 3 trials and subsequent
commercialization. Phase 2b ongoing (sponsored by Biotie) with results
expected H1 2013.
* SYN120: An orally administered antagonist of the 5-HT(6) receptor in
development for the treatment of Alzheimer's disease and other cognitive
disorders, including schizophrenia. Roche has an option on the development
and commercialization of SYN120 following an ongoing clinical imaging study
using Positron Emission Tomography which is expected to complete in H1
2012.
* SYN117 (nepicastat): An orally administered, potent and selective inhibitor
of the enzymedopamine beta-hydroxylase (DBH). The compound is in a Phase 2
study, funded by the US Department of Defense, for the treatment of post-
traumatic stress disorder (PTSD); results are expected in 2013.
* BTT-1023 (VAP-1 antibody): A fully human antibody against vascular adhesion
protein-1 (VAP-1). It has completed two Phase 1b studies in rheumatoid
arthritis and psoriasis and Biotie expects to start proof-of-concept
clinical studies in selected indications in H2 2012. Biotie has licensed the
rights to develop and commercialize its VAP-1 antibody in Japan, Taiwan,
Singapore, New Zealand and Australia to Seikagaku Corporation.
* Ronomilast: A small-molecule, phosphodiesterase-4 (PDE4) inhibitor in
development for the treatment of chronic obstructive pulmonary disease
(COPD). Biotie is seeking a partner for further development and
commercialization of this product.
Financial calendar 2012:
Biotie's financial statement release 2011 will be published February 24, 2012.
Financial Statements 2011 will be published March 8, 2012.
Biotie Therapies Corp. will publish its Corporate Governance Statement 2011 on
March 8, 2012. The statement will be published separately from the Board of
Directors' report and it will be available on Biotie's website www.biotie.com.
Interim report January - March May 4, 2012
Interim Report for January - June August 3, 2012
Interim Report for January - September November 2, 2012
Biotie's Annual General Meeting will be held on March 29, 2012.
Conference call
An analyst and media conference call will take place on 4 November 2011 at
10:00 a.m. Central European Time. The conference call will be held in English.
Callers may access the conference call directly at the following telephone
numbers: US: +1 646 254 3363 UK: +44 (0)20 7136 2050 and Finland: +358 (0)9
6937 9590 access code 8164470. Lines are to be reserved ten minutes before the
start of conference call. The event can also be viewed as a live webcast at
www.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
About Biotie
Biotie is an international biopharmaceutical company focused on the development
of innovative, clinically differentiated medicines to address unmet medical
needs primarily associated with neurological and psychiatric diseases and
selected inflammatory diseases. Biotie aims to develop treatment solutions that
will improve the lives of patients with conditions such as Parkinson's and
Alzheimer's diseases, drug dependence and inflammatory liver disease.
Biotie's highly experienced development teams in Europe and the US are focused
on efficiently delivering safety and efficacy data for the company's compounds.
For niche indications, Biotie will consider bringing products to market by
itself. For larger indications, it will seek strategic partnerships with
pharmaceutical partners for late-stage development and commercialization.
Current pharmaceutical partners include Lundbeck, Roche, UCB Pharma, and
Seikagaku.
Biotie's most advanced product, nalmefene for alcohol dependence, has completed
Phase 3 clinical development by licensing partner Lundbeck.
Group structure: The parent company of the group is Biotie Therapies Corp. The
domicile of the company is Turku, Finland. The company has two non-operational
subsidiaries named Biotie Therapies GmbH, located in Radebeul, Germany and
Biotie Therapies International Ltd in Finland.
Following the acquisition of Synosia Therapeutics, the company has a holding
subsidiary, Biotie Therapies Holding AG, located in Basel, Switzerland, which
has two operative subsidiaries, Biotie Therapies AG, located in Basel,
Switzerland and Biotie Therapies, Inc. located in South San Francisco,
California.
Drug development projects:
Nalmefene is a small molecule opioid receptor antagonist that inhibits the
reward pathway in the brain that reinforces the desire and craving for alcohol.
As a result, nalmefene removes a person's desire to drink.
Biotie has licensed global rights to nalmefene to H. Lundbeck A/S (Lundbeck).
Under the terms of the agreement, Biotie is eligible for up to EUR 84 million in
upfront and milestone payments plus royalties on sales from Lundbeck. Biotie has
already received EUR 12 million from Lundbeck. Further milestone payments are
expected on commercial launch of nalmefene and on the product reaching certain
predetermined sales. Lundbeck will be responsible for manufacturing and
registration of the product.
Lundbeck announced in June the completion of ESENSE2, the last study in its
Phase 3 program evaluating nalmefene for the treatment of alcohol dependence.
Results from this 718 patient, double-blind, placebo controlled trial were
consistent with the profile observed in previous clinical studies of nalmefene.
Lundbeck plans to file a marketing authorization application (MAA) in Europe by
year end 2011.
Lundbeck assessed a wide range of primary and secondary endpoints in its Phase
3 program for nalmefene including: number of heavy drinking days per month,
total alcohol consumption, proportion of responders based on drinking measures,
alcohol dependence symptoms and clinical status, liver function and other
laboratory tests, pharmaco-economic outcomes and treatment discontinuation
effects. All assessments were consistently in favour of nalmefene compared to
placebo, though some were not statistically significant at every single time
point. Overall, nalmefene reduced heavy drinking days and total alcohol
consumption by more than 50% compared to pre-treatment baseline. The effect was
observed during the first month of treatment and was maintained throughout the
study period in the three trials.
Furthermore, data from the 12-month safety study (SENSE) confirmed that the
treatment effect of nalmefene was maintained and even improved after 1 year of
treatment. Approximately two-thirds of the individuals in the studies had
previously not been treated for alcohol dependence, despite an ongoing
affliction, indicating that reduction of alcohol intake represents an attractive
treatment objective compared to current treatments which all require abstinence.
The safety profile of nalmefene was consistent with observations and data
provided in earlier studies, including Biotie's previously completed Phase 3
program. The most frequent adverse events in patients taking nalmefene were
dizziness, insomnia and nausea. These adverse events were usually mild and
transient in nature. The three studies in the Lundbeck Phase 3 clinical program
were conducted in Europe and enrolled about 2,000 individuals with alcohol
dependence. Including prior studies conducted by Biotie, the total clinical
database now contains more than 3,000 patients with alcohol dependence.
SYN115 (tozadenant) is an orally bioavailable, potent and selective adenosine
A2a receptor antagonist in development for Parkinson's disease (PD). Adenosine
A2a inhibition with SYN115 has been shown in preclinical studies to reverse
motor deficits and enhance the effect of current PD therapies, e.g. levodopa and
dopamine agonists, without inducing troublesome dyskinesia (involuntary
movements). In addition, SYN115 also displays activity in preclinical models on
non-motor symptoms of PD including depression, cognition and anxiety.
Biotie announced in April the start of a Phase 2b trial evaluating SYN115 in PD.
The trial is a randomized, double-blind, placebo-controlled study that will
evaluate four doses of SYN115 versus placebo as adjunctive therapy in 400
levodopa-treated PD patients with end of dose wearing off. In these patients,
treatment with levodopa is insufficient to control PD symptoms until their next
dose, resulting in an 'off' period when symptoms reappear. The aim of the trial
is to determine the efficacy and safety of SYN115 in reducing the mean time
spent in the 'off' state over a 12 week treatment period. The study will also
assess the impact of SYN115 on various measures of motor symptom severity,
dyskinesia and non-motor symptoms. Results from the Phase 2b trial are expected
H1 2013.
Biotie has granted UCB Pharma S.A. a license for exclusive, worldwide rights to
SYN115. UCB will be responsible for Phase 3 development and commercialization.
SYN120 is an orally bioavailable, potent and selective antagonist of the 5-HT(6)
receptor. The 5-HT(6) receptors are exclusively located in the brain and
antagonism of these receptors modulates the release of acetylcholine and
glutamate, two neurotransmitters known to be involved with memory function.
Cognitive deficits are an important component of many CNS diseases, especially
Alzheimer's and schizophrenia. SYN120 has completed single and multiple
ascending dose Phase 1 clinical studies and a Phase 1 PET ("positron emission
tomography") imaging study is currently underway to determine therapeutic dose
for subsequent Phase 2 studies. This trial is expected to conclude during H1
2012. The compound was originally licensed from Roche and Roche has an option to
reacquire this program after the results of the ongoing study have been
obtained.
BTT-1023 (VAP-1 antibody) Biotie has recently generated new data indicating that
its proprietary target VAP-1, in addition to its clinically demonstrated role in
inflammatory diseases, has an important role in fibrotic diseases. These data,
generated in part in collaboration with National Institute for Health Research
Liver Biomedical Research Unit at the University of Birmingham, UK, reveal
significant potential for Biotie's fully human VAP-1 antibody (BTT-1023) in
certain niche liver inflammatory fibrotic diseases. These data will be published
at upcoming scientific and medical conferences and represent potentially new and
exciting development opportunities for BTT-1023 in a range of conditions. Biotie
is currently optimizing the scale-up of the manufacturing process for BTT-1023
and expects to start proof-of-concept clinical studies in selected indications
in H2 2012. Biotie has previously demonstrated encouraging efficacy and safetyfor BTT-1023 in early clinical studies in rheumatoid arthritis and psoriasis
patients and in a range of preclinical models of inflammatory diseases,
including COPD and certain neurological conditions. The company will continue
discussions with potential partners, outside Seikagaku's territory, for the
indications targeting large markets
Ronomilast is a once-daily, potentially best-in-class 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 three clinical studies
with a total of 126 subjects ronomilast has been demonstrated to be safe and
well tolerated at all tested doses up to 100mg once daily. Robust and
statistically highly significant biomarker responses confirmed the
pharmacological activity of well tolerated doses of ronomilast in man. Due to
the complexity and size of studies required for the development of medicines for
the treatment of COPD, Biotie has decided that a corporate partnership is
required to optimize the development path for ronomilast. The company will not
invest in further clinical studies without a partner.
Nepicastat (SYN117) is a potent, competitive, and selective inhibitor of the
enzyme dopamine beta-hydroxylase. The inhibition of this enzyme has been shown
to raise dopamine levels in the central nervous system (CNS). Nepicastat is
available as an oral treatment and has been well-tolerated in preclinical models
at doses significantly above the expected therapeutic range for the current CNS
indications under investigation. A Phase 2 study of nepicastat in post traumatic
stress disorder is ongoing, funded by the US Department of Defense. No data from
this study is expected to become available before 2013. There is strong
scientific and medical rationale for the use of SYN117 in the treatment of
cocaine dependency and discussions are ongoing to seek further funding for this
indication.
Financial review for reporting period January - September 2011
Financial statements for the period January-September 2011 are not directly
comparable to the same period in 2010 due to the Synosia Therapeutics
acquisition and the consolidation of the new subsidiaries' results into the
Biotie group's consolidated financial statements from the acquisition date 1
February onwards.
Revenues: Revenues for the reporting period amounted to EUR 1.0 million (EUR
1.5 million in the same period in 2010). Revenues consisted of periodization of
previously received upfront payments from licensing agreements.
Financial result: Net loss for the reporting period 2011 was EUR 28.5 million
(EUR 6.0 million for continuing operations in the same period in 2010). This has
been impacted by a non-cash impairment charge of EUR 11.7 million for SYN118
arising from the uncertainty and likelihood of UCB exercising its licensing
option or further internal development of this product.
Research and development costs for the reporting period amounted to EUR 29.7
million including impairment of SYN118 (EUR 4.4 million in the same period in
2010, continuing operations). The increase in research and development costs and
in net loss was due to the acquisition of Synosia. Total comprehensive income
including the currency translation differences amounted to EUR -24.8 million
(EUR -13 million in the same period 2010).
Discontinued operations relate to the restructuring plan initiated in October
2010. The restructuring plan targeted achieving annual savings of at least EUR
4.0 million from 2011 onwards. The group is on track to achieve the expected
savings by the end of 2011.
Financing: Cash, cash equivalents and short term investments totaled EUR 37.2
million on 30 September 2011 (EUR 8.9 million on 30 September 2010). The groups'
financial position has been strengthened by a private placement of EUR 27
million in March 2011 and furthermore by the liquid assets of Synosia acquired
in February 2011.
Biotie has a standby equity distribution agreement (SEDA) in place with US fund
Yorkville. 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 in H2 2010 and
raised a total amount of EUR 1.1 million.
Shareholder's equity: The shareholders' equity of the group amounted to EUR
74.1 million (IFRS) on 30 September 2011. Biotie's equity ratio was 61.8% on 30
September 2011 (-127.5% on 30 September 2010). Equity was strengthened by the
share issues related to Synosia acquisition as well as the private placement
executed in Q1 2011.
Investments and cash flow: Cash flow from operating activities in January -
September amounted to EUR -14.3 million for continuing operations (EUR -7.1
million in the same period in 2010) and EUR -2.4 million for discontinued
operations (EUR -3.4 million in the same period in 2010). Operating cash outflow
for continuing operations was EUR 7.2 million higher than in the same period in
2010 mainly due to the acquisition of Synosia. Cash flow for discontinued
operations related to the restructuring plan and spin-off of Biotie's operations
in Radebeul, Germany (now Biocrea GmbH) initiated in October 2010. No further
cash out-flow related to the Biocrea spin-off is expected in the future.
The group's investments in tangible and intangible assets during the reporting
period amounted to EUR 38 thousand (EUR 264 thousand in the same period in
2010).
Changes in the management team
Biotie's interim Chief Financial Officer Ulla Sjöblom left the company to pursue
other interests. Zack McNealy, Vice President, Finance of the group's US
subsidiary assumed the role of acting Chief Financial Officer starting September
1, 2011.
Personnel
During the reporting period January - September 2011, the average number of
employees amounted to 37 (82 during January - September 2010) and at the end of
the reporting period, after the restructuring in Q4 2010 and acquisition of
Synosia in Q1 2011, Biotie employed 35 people (81 on 30 September 2010).
Option rights
Biotie has issued option rights to certain of its employees and managers
pursuant to two different option programs in 2006 and 2009. Each option right
granted based on these two option programs entitle to subscribe one share in the
company.
The Swiss company Synosia Therapeutics Holding AG (currently Biotie Therapies
Holding AG) acquired by Biotie in February 2011 also has a stock option plan
based on which stock options have been granted to employees, directors and
consultants.
The Swiss subsidiary of Biotie Therapies Corp. Biotie Therapies Holding AG
(previously Synosia Therapeutics Holding AG) conveyed 2,132,860 (reported in 6
June, 2011), conveyed 899,071 (reported in 5 July, 2011), conveyed 374.161
(reported in 3 August) and conveyed 89,728 (reported in 2 September) of Biotie
shares (a total of 3,495,820 Biotie shares) against consideration pursuant to
the option programs.
The conveyed shares previously held by the Company's subsidiary have not carried
any voting rights. As a result of the conveyances, the total number of votes
attached to Biotie's shares increased by 3,495,820 votes to 376,178,122 votes.
The conveyance does not affect the number of registered shares (total of
387,594,457 shares) but the number of the Company's shares held by the Biotie
Therapies group is reduced to 11,416,335 shares. The parent company Biotie does
not own any treasury shares.
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 quoted on NASDAQ OMX Helsinki Ltd (Small cap). Since July, 2011
Biotie has been classified as Biotechnology (GICS - Global Industry
Classification Standard) by MSCI (Morgan Stanley Capital International).
On 30 September 2011 the registered number of shares in Biotie Therapies Corp.
was 387,594,457. Of these shares 11,416,335 were held by the company or its
group companies. The registered share capital of Biotie was EUR 165,919,181.95.
Market capitalization and trading
At the end of the reporting period the share price was EUR 0.45 the highest
price during the reporting period January - September 2011 was EUR 0.82, the
lowest was EUR 0.34, and the average price was EUR 0.59. Biotie's market
capitalization at the end of the reporting period was EUR 174.4 million.
The trading volume on NASDAQ OMX Helsinki during the reporting period January -
September was 208,844, 063 shares, corresponding to a turnover of EUR
122,342,214
Shareholders' meetings
Extraordinary General meeting held on 1 February:
The stock exchange release regarding the resolutions of the Extraordinary
General Meeting of Biotie Therapies Corp. was published on 1 February 2011.
Annual General Meeting was held on 6 May
The stock exchange release regarding the resolutions of the Annual General
Meeting of Biotie Therapies Corp. was published on 6 May 2011.
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 two major sources: income from its
license partners and raising equity financing in the capital markets.
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 very volatile. While in March 2011 the company was able to raise
a significant amount of cash from a share issue to fund its operations in the
mid-term future, there can be no assurance that the company can secure equity
financing in the future if and when it needs it.
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. While income generated from
commercial agreements with third parties relating to its clinical programs might
significantly improve Biotie's 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
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 in Q4 2010 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
policies as for the 2010 financial statements. The interim report has not been
prepared in accordance with IAS 34, Interim Financial Reporting.
In addition, as a result of the acquisition of Synosia Therapeutics, Biotie has
applied the following principle beginning with the Q1 2011 financial statements:
The results and financial position of all the group entities that have a
currency different from the presentation currency are translated into the
presentation currency as follows:
a. Assets and liabilities for each balance sheet presented are translated at
the closing rate at the date of that balance sheet.
b. Income and expenses for each income statement are translated at average
exchange rates.
c. All resulting exchange differences are recognised in other comprehensive
income.
On consolidation, exchange differences arising from the translation of the net
investment in foreign operations, and of inter-company borrowings that are
considered of being part of the net investment, are taken to other comprehensive
income. When a foreign operation is disposed of or sold (either partially or as
a whole), exchange differences that were recorded in equity are recognised in
the income statement.
Goodwill and fair value adjustments arising on the acquisition of a foreign
entity are treated as assets and liabilities of the foreign entity and
translated at the closing rate.
This interim report is unaudited.
Turku, 4 November 2011
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
Media contact:
Julie Walters, Tudor Reilly
Office: +44 (0) 20 7034 7610
Mobile +44 (0) 775 362 6967
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.-
30.9.2011 30.9.2010 30.9.2011 30.9.2010 31.12.2010
EUR 1,000 3 months 3 months 9 months 9 months 12 months
--------------------------------------------------------------------------------
Continuing operations
Revenue 31 473 977 1,482 1,955
Research and -20,355 -963 -29,701 -4,381 -5,538
development expenses
General and -2,149 -784 -6,888 -2,713 -4,216
administrative expenses
Other operating income 284 41 790 125 166
--------------------------------------------------------------------------------
Operating profit/loss -22,190 -1,233 -34,823 -5,487 -7,633
Financial income 222 24 369 89 101
Financial expenses 576 -207 -1,440 -615 -930
--------------------------------------------------------------------------------
Profit/loss before taxes -21,391 -1,416 -35,893 -6,013 -8,462
Taxes 5,206 0 7,387 0 0
--------------------------------------------------------------------------------
Net income/loss, continuing -16,185 -1,416 -28,506 -6,013 -8,462
operations
Net income/loss, discontinued 0 -4,504 0 -7,000 -13,111
operations
--------------------------------------------------------------------------------
Net income/loss -16,185 -5,920 -28,506 -13,013 -21,573
Other comprehensive income:
Currency translation 3,107 0 3,706 0 0
differences
--------------------------------------------------------------------------------
Total comprehensive income of -13,078 -5,920 -24,800 -13,013 -21,573
the period
Net income/loss attributable
to
Parent company shareholders -16,185 -5,920 -28,506 -13,013 -21,573
Total comprehensive income
attributable to:
Parent company shareholders -13,078 -5,920 -24,800 -13,013 -21,573
Earnings per share (EPS)
basic & diluted, EUR, -0.04 -0.01 -0.08 -0.04 -0.06
continuing operations
Earnings per share (EPS)
basic & diluted, EUR, 0.00 -0.03 0.00 -0.04 -0.09
discontinued operations
CONSOLIDATED STATEMENT OF FINANCIAL POSITION
(IFRS) EUR 1,000
30.9.2011 30.9.2010 31.12.2010
--------------------------------------------------------------------------------
Assets
Non-current assets
Intangible assets 73,325 4,055 4,042
Goodwill 5,402 0 0
Property, plant and equipment 335 1,939 365
Investment property 1,393 0 1,468
Other shares 10 10 10
--------------------------------------------------------------------------------
80,465 6,004 5,885
Current assets
Available for sale investment 0 34 0
Investments held to maturity 14,000 3,000 0
Accounts receivables and other receivables 2,201 1,113 1,261
Financial assets at fair value through 2,731 0 0
profit or loss
Cash and cash equivalents 20,513 5,924 4,059
Non-current assets classified as held for sale 0 1,104 0
--------------------------------------------------------------------------------
39,445 11,175 5,320
Total 119,910 17,179 11,205
Equity and liabilities
Shareholders' equity
Share capital 166,446 49,925 43,378
Share issue 0 50 500
Reserve for invested unrestricted equity 4,444 1,180 1,180
Cumulative translation adjustment 3,706 0 0
Retained earnings -71,984 -53,051 -52,951
Net income/loss -28,506 -13,013 -21,573
--------------------------------------------------------------------------------
Shareholders' equity total 74,105 -21,909 -29,466
Non-current liabilities
Provisions 0 4 0
Non-current financial liabilities 25,811 25,657 25,640
Pension benefit obligation 430 0 430
Other non-current liabilities 8,012 7,258 7,442
Non-current deferred revenues 277 399 368
Deferred tax liabilities 2,820 0 0
--------------------------------------------------------------------------------
37,349 33,318 33,880
Current liabilities
Provisions 570 591 589
Pension benefit obligation 16 0 16
Current financial liabilities 72 171 144
Current deferred revenues 120 1,448 1,006
Accounts payable and other current liabilities 7,678 2,456 2,637
Liability associated with assets classified as 0 1,104 0
held for sale
Liability related to discontinued operations 0 0 2,400
--------------------------------------------------------------------------------
8,456 5,770 6,791
Liabilities total 45,805 39,088 40,671
Total 119,910 17,179 11,205
CONSOLIDATED STATEMENT OF CHANGES IN SHAREHOLDERS' EQUITY
Attributable to equity holders of the parent company
EUR 1,000 Shares Share Share Reserve Own Retained Share-
(1000 Capital issue for Shares Earnings holders'
pcs) invested equity
un- total
restricted
equity
--------------------------------------------------------------------------------
BALANCE AT 158,753 43,057 0 1,180 -15 -53,160 -8,938
1.1.2010
--------------------------------------------------------------------------------
Total -21,573 -21,573
comprehensive
income for the
period
Options granted 108 108
SEDA costs 116 116
Share issue to the 17,251 0
company itself
without
consideration
Directed issue of 550 500 1,050
treasury shares
Cost of share -229 -229
issue
--------------------------------------------------------------------------------
17,251 321 500 0 0 -21,349 -20,528
--------------------------------------------------------------------------------
BALANCE AT 176,004 43,378 500 1,180 -15 -74,509 -29,466
31.12.2010
--------------------------------------------------------------------------------
Total -24,800 -24,800
comprehensive
income for the
period
Options granted 2,662 2,539 5,201
Options exercised 602 602
Directed issue of 500 -500 0
treasury shares
Directed issues of 211,590 115,893 115,893
new shares
Directed offer of 7,964 7,964
treasury shares
Cost of share -1,289 -1,289
issue
--------------------------------------------------------------------------------
211,590 123,067 -500 3,265 0 -22,261 103,571
--------------------------------------------------------------------------------
BALANCE AT 387,594 166,446 0 4,444 -15 -96,770 74,105
30.9.2011
--------------------------------------------------------------------------------
CONSOLIDATED STATEMENT OF CASH FLOWS
1.1.- 1.1.- 1.1.-
30.9.2011 30.9.2010 31.12.2010
EUR 1,000 9 months 9 months 12 months
--------------------------------------------------------------------------------
Cash flow from operating activities
Continuing operations
Net income/loss -28,506 -6,013 -8,462
Adjustments:
Non-cash transactions 15,411 -1,154 -1,287
Acquisition related costs 759 0 0
Interest and other financial expenses 607 612 930
Interest income -259 -117 -101
Foreign exchange losses/gains on operating 80 0 0
activities
Taxes -3,143 0 0
Change in working capital:
Change in accounts receivables and other 401 -158 626
receivables
Change in accounts payable and other 301 -255 436
liabilities
Change in mandatory provisions -18 -18 -25
Interests paid -42 -31 -42
Interests received 75 56 68
Taxes paid 6 0 0
--------------------------------------------------------------------------------
Net cash from operating activities, continuing -14,328 -7,078 -7,856
operations
Net cash from operating activities, discontinued -2,400 -3,444 -7,011
operations
--------------------------------------------------------------------------------
Net cash from operating activities -16,728 -10,522 -14,867
Cash flow from investing activities
Continuing operations
Acquisition of subsidiary, net of cash acquired 15,489 0 0
Change in financial assets at fair value through
profit or loss
Additions 0 0 0
Disposals 4,212 8,886 8,886
Change in investments held to maturity
Additions -19,000 -3,000 0
Disposals 5,000 0 0
Investments to tangible assets -36 -53 -54
Investments to intangible assets -2 0 0
--------------------------------------------------------------------------------
Net cash used in investing activities, continuing 5,663 5,834 8,832
operations
Net cash used in investing activities, 0 -211 -1,587
discontinued operations
--------------------------------------------------------------------------------
Net cash used in investing activities 5,663 -5,623 7,245
Cash flow from financing activities
Continuing operations
Payments from share issue 27,589 50 1,050
Share issue costs -1,185 -132 -229
Proceeds from borrowings 226 6 6
Repayment of loans -40 -40 -40
Repayment of lease commitments -87 -132 -177
--------------------------------------------------------------------------------
Net cash from financing activities, continuing 26,504 -248 610
operations
Net cash from financing activities, discontinued 0 180 180
operations
--------------------------------------------------------------------------------
Net cash from financing activities 26,504 -68 791
Net increase (+) or decrease (-) 15,439 -4,967 -6,832
in cash and cash equivalents
Effect on changes in exchange rates on cash and 1,014 0 0
cash equivalents
Cash and cash equivalents at the 4,059 10,891 10,891
beginning of the period
Cash and cash equivalents at the 20,513 5,924 4,059
end of the period
ACQUISITION OF SYNOSIA THERAPEUTICS HOLDING AG
Biotie acquired Synosia Therapeutics Holding AG ("Synosia") on February 2011.
Today, Synosia is a wholly-owned subsidiary of Biotie and is consolidated into
Biotie's consolidated financial statements from the acquisition date onwards.
Notes required by IFRS3 Business combinations have been presented in Q1 2011
interim report released May 13, 2011.
SYNOSIA OPTION PLAN
As a result of the combination agreement signed with Synosia Therapeutics
Holding AG Biotie Therapies Corp. has issued 14,912,155 shares as a bonus issue
to its subsidiary Biotie Therapies Holding AG to be held in treasury and to be
used to satisfy exercise of Biotie Therapies Holding AG (formerly Synosia
Therapeutics Holding AG) options in accordance with the existing Biotie
Therapies Holding AG option plans.
The option plan has been described more in detail in Q1 2011 interim report
released May 13, 2011.
The following table provides information on the number and pricing of options at
September 30, 2011
Amount Weighted average exercise price
Options exercised 3,495,820 0.17
Options outstanding 11,155,967 0.21
Options exercisable 8,384,139 0.16
Contingent liabilities
EUR 1,000 30.9.2011 30.9.2010 31.12.2010
----------------------------------------------------------
Operating lease commitments 447 124 159
Due within a year 230 81 70
Due later 217 43 88
Rent commitments 76 264 243
Due within a year 76 238 243
Due later 0 26 0
----------------------------------------------------------
Total 523 388 402
The Group leases motor vehicles, machines and equipment with leases of 3 to 5
years. Rent commitments include subleased Pharmacity premises until 30 November
2011.
Commitments
On 30 September 2011 Biotie had purchase commitments, primarily for contract
research work services, totaling EUR 11.8 million.
TRANSACTIONS WITH RELATED PARTIES
There have not been major changes within the related party transactions in 2011.
KEY FIGURES
The formulas for the calculation of the key
figures are presented in the notes of the
consolidated financial statements 2010
Incl. both continuing and discontinued 1.1.- 1.1.- 1.1.-
operations 30.9.2011 30.9.2010 31.12.2010
EUR 1,000 9 months 9 months 12 months
--------------------------------------------------------------------------------
Business development
Revenues 977 2,455 2,928
Personnel on average 37 82 70
Personnel at the end of period 35 81 23
Research and development costs -29,701 10,148 12,229
Capital expenditure 38 264 270
Profitability
Operating profit/loss -34,823 -9,587 -20,720
as percentage of revenues, % -3,564.3 -390.5 -707.65
Profit/loss before taxes -35,893 -13,013 -21,573
as percentage of revenues, % -3,673.8 -530.1 -736.78
Balance sheet
Liquid assets 37,244 8,924 4,059
Shareholders' equity 74,105 -21,909 -29,466
Balance sheet total 119,910 17,179 11,205
Financial ratios
Return on equity, % - - -
Return on capital employed, % -97.7 -131.3 -341.5
Equity ratio, % 61.8 -127.5 -263.0
Gearing, % -15.3 -77.2 -73.7
Per share data
Earnings per share (EPS) basic, EUR -0.08 -0.08 -0.15
Earnings per share (EPS) diluted, EUR -0.08 -0.08 -0.15
Shareholders' equity per share,€ 0.19 -0.14 -0.17
Dividend per share, EUR - - -
Pay-out ratio, % - - -
Effective dividend yield, % - - -
P/E-ratio - - -
Share price
Lowest share price, EUR 0.34 0.41 0.30
Highest share price, EUR 0.82 0.65 0.65
Average share price, EUR 0.59 0.53 0.48
End of period share price, EUR 0.45 0.44 0.50
Market capitalization 174.4 69.9 88.0
at the end of period MEUR
Trading of shares
Number of shares traded 208,844,063 49,462,429 90,049,678
As percentage of all 53.9 31.2 51.2
Adjusted weighted average 357,650,868 158,752,560 161,919,250
number of shares during the period
Adjusted number of shares 387,594,457 158,752,560 176,003,931
at the end of the period
[HUG#1560910]
© 2024 Nasdaq, Inc. All Rights Reserved |