2009-10-23 07:30:00 CEST
2009-10-23 07:32:31 CEST
REGULATED INFORMATION
Biotie Therapies - Interim report (Q1 and Q3)
Biotie Therapies Corp. interim report January 1 - September 30, 2009
BIOTIE THERAPIES CORP. INTERIM REPORT October 23, 2009
at 8.30 a.m.
Biotie Therapies Corp. interim report January 1 - September 30, 2009
January - September 2009 in brief
- 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.
- Biotie's Annual General Meeting was held on 29 May 2009.
- Revenue for January - September amounted to EUR 4.5 million (EUR
4.0 million in 2008). Cash flow from operating activities in January
- September was EUR -8.8 million (EUR -7.9 million for the same
period in 2008).
- The net loss for January - September stood at EUR 8.3 million (net
loss for comparable period in 2008 was EUR 3.8 million) excluding
extraordinary items in relation to write-offs of certain intangible
assets. Total net loss for January - September including
extraordinary items in relation to write-offs of intangible assets
was EUR 12.1 million (net loss for January - September 2008 was EUR
3.8 million) and earnings per share for the period was EUR -0.08(EUR
-0.04 in 2008).
- As of September 30, the company's liquid assets amounted to EUR
16.7 million (EUR 21.0 million as of September 30, 2008).
Q3/2009 in brief:
- 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 August, Biotie reached a milestone in its collaboration with
Wyeth for the development of PDE10 (phosphodiesterase 10) inhibitors
for schizophrenia, triggering a USD 1.0 million milestone payment to
Biotie.
- 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. Results are expected in the first half of 2010.
- On September 28, the Board of Directors resolved to call an
Extraordinary General Meeting of shareholders to be held on October
29, 2009. Among others, it proposes to elect Dr. Peter Fellner as new
member of the Board of Directors.
Furthermore, it proposes to authorize the Board of Directors to
resolve on one or more issues which contains the right to issue new
shares or dispose of the shares in the possession of the company and
to issue options or other specific rights to the shares pursuant to
chapter 10 of the Companies Act. The authorisation would consist of
up to 72,000,000 shares in the aggregate and would supersede earlier
authorizations. The authorisation is proposed to be used for material
arrangements from the company's point of view, such as financing or
implementing business arrangements or investments or for other such
purposes determined by the Board of Directors in which case a weighty
financial reason for issuing shares, options or other specific rights
and possibly directing a share issue would exist. The authorisation
could not, however, be used to create new share-based incentive
schemes.
- In September 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.
- Revenue for July - September stood at EUR 1.8 million (EUR 0.8
million in 2008) and earnings per share was EUR -0.02 (EUR -0.01 in
2008).
- The net loss for July - September stood at EUR 2.5 million (net
loss of comparable period in 2008 was EUR 0.5 million). Cash flow
from operating activities in July - September was EUR -2.1 million
(EUR -2.1 million for comparable period in 2008).
Events after the reporting period
- In order to secure the financing of Biotie's working capital in the
short and medium term, the Company has entered into a Standby Equity
Distribution Agreement with YA Global Master SPV Ltd. ("YA Global") a
fund managed by Yorkville Advisors, LLC of Jersey City, New Jersey,
USA ("Yorkville"). Under the terms of the agreement, Biotie has the
option, at the sole and exclusive discretion of the Company, to take
up YA Global's commitment to subscribe and pay for ordinary no-par
Biotie shares up to a total value of 20 million euro over a period of
36 months.
Timo Veromaa, Biotie's President and CEO:"We are pleased with the progress that we have made this quarter,
including the initiation of an additional Phase I trial with our PDE4
inhibitor and having achieved an important milestone in our Wyeth
collaboration. Additionally, our other programs remain on track,
including nalmefene phase III clinical studies and our VAP-1 antibody
Phase Ib studies. Furthermore, the secured equity distribution
agreement with Yorkville provides us with added financial flexibility
to raise funds through equity issues at our discretion. Strengthening
of our financial position while advancing the development of our key
R&D programs remains the focus of the company for the near and mid
term."
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 Drug Development Projects in Clinical or
Pre-clinical Stages:
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.
At the end of 2008, licensing partner Lundbeck launched three phase
III trials, which seek to enroll about 1,800 patients. The first 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 last 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 during the first half of
2011. Biotie is participating in financing some of the clinical
development costs.
Lundbeck has worldwide rights for Nalmefene, excluding South-Korea.
Under the terms of the Biotie-Lundbeck license agreement, Biotie is
eligible for up to EUR 84 million in upfront and milestone payments
plus royalties on sales.
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, areas which have posed significant
development hurdles for PDE4 inhibitors in the past. Furthermore,
blood plasma profiles of ELB353 showing pronounced and long lasting
exposure support once-daily dosing.
Biotie is currently conducting a clinical study with ELB353 within
the European Union with the aim to 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 mediating the inflammatory events associated with
chronic diseases such as rheumatoid arthritis, psoriasis and
diabetes. VAP-1 also may be potentially applicable to 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 and is now conducting two multiple dose
clinical studies in rheumatoid arthritis and psoriasis patients,
which were respectively initiated in February and March 2009. These
studies aim to establish appropriate dosing regimens for subsequent
therapeutic studies and provide initial information on the antibody's
therapeutic potential.
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 initial option right will
end upon completion of the ongoing phase I studies.
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 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 Wyeth
Pharmaceuticals since December 2006. In August 2009, Biotie reached a
milestone in its collaboration with Wyeth, triggering a USD 1.0
million milestone payment. According to the agreement with Wyeth,
Biotie is eligible for up to USD 110 million in signing fee,
milestone payments and research funding. Biotie will in addition be
eligible for royalties on sales.
Revenues
Revenue for the period of January 1 to September 30 amounted to EUR
4.5 million (in the same period 2008, EUR 4.0 million). Revenue
consisted of milestone payment and income from the ongoing research
collaboration with Wyeth 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 September 30, EUR 1.4 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 2.4 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 as other operating income.
Financial results
The net loss for the reporting period was EUR 8.3 million excluding
extraordinary items in relation to write-offs of intangible assets.
Total net loss for January-September 2009 including extraordinary
items amounted to EUR 12.1 million. The corresponding loss for the
previous year was EUR 3.8 million, no extraordinary items were
reported. Research and development costs for the period amounted to
EUR 11.3 million, excluding extraordinary items (in 2008 EUR 6.3
million).
Impairment losses were recorded 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 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 16.7 million on September 30,
2009 (EUR 21.0 million on September 30, 2008).
The company has predominantly 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 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 -11.8 million.
Biotie's equity ratio was -41.0 % on September 30, 2009 (-64.0 % in
2008).
According to Finnish Accounting Standards (FAS), shareholders' equity
is less than half of the parent company's share capital. The
company's share capital is EUR 44.3 million, shareholders' equity is
EUR 7.8 million and capital loans stand at EUR 21.3 million. Thus,
shareholders' equity plus capital loans add up to EUR 29.1 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 -8.8 million for January -
September 2009 (comparable period in 2008 EUR -7.9 million). The
group's investments during the reporting period amounted to EUR 426
thousand (EUR 110 thousand in 2008).
Personnel
During the reporting period January - September 2009, the company's
personnel was on average 81(35 during January - September, 2008) and
at the end of the reporting period 83 (34 on September 30, 2008). The
increase is due to the inclusion of the German subsidiary, which was
acquired in November 2008.
Extraordinary General Meeting
On September 28, the Board of Directors resolved to call an
Extraordinary General Meeting of shareholders to be held on October
29, 2009. It proposes to elect Dr. Peter Fellner as new member of the
Board of Directors. Furthermore, it proposes to authorize the Board
of Directors to resolve on one or more issues which contains the
right to issue new shares or dispose of the shares in the possession
of the company and to issue options or other specific rights to the
shares pursuant to chapter 10 of the Companies Act. The authorisation
would consist of up to 72,000,000 shares in the aggregate and would
supersede earlier authorizations. The authorisation is proposed to be
used for material arrangements from the company's point of view, such
as financing or implementing business arrangements or investments or
for other such purposes determined by the Board of Directors in which
case a weighty financial reason for issuing shares, options or other
specific rights and possibly directing a share issue would exist. The
authorisation could not, however, be used to create new share-based
incentive schemes. Due to the recent amendment to the Finnish
Companies Act, the Board also proposes to amend the articles of
association accordingly.
Group structure
The parent company of the group is Biotie Therapies Corp. The
domicile of the Company is Turku, Finland. The group has an operative
subsidiary, Biotie Therapies GmbH, located in Radebeul, Germany.
During Q3 2009, Biotie Therapies GmbH has wound down its former
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.
The parent company also has a non-operational subsidiary named Biotie
Therapies International Ltd in Finland and an associated company with
no activities, Contral USA which is domiciled in Delaware, USA.
Share capital and Shares
Biotie's shares are quoted on the NASDAQ OMX Helsinki Ltd (Small cap,
Healthcare). Biotie Therapies has 144,320,560 shares outstanding and
the share capital amounts to EUR 44,290,678.10 (under Finnish
Accounting Standards, FAS). All the company's shares are of the same
series and have equal rights. All the shares are freely transferable
and contain one voting right each.
The company has in its possession 819.000 of its own shares. The
company has a stock lending agreement with EVLI Bank in place in
relation to the company's option programs. Pursuant to this
agreement, the number of the company's own shares in its possession
may be temporarily less than 819,000.
At the end of September the share price was EUR 0.58, the highest
price during January - September was EUR 0.67, the lowest was EUR
0.23, and the average price was EUR 0.38. Biotie's market
capitalization at the end of September was EUR 83.7 million.
The trading volume on NASDAQ OMX Helsinki during the reporting period
January - September was 29,903,949 shares, corresponding to a
turnover of EUR 10.89 million.
LP market making agreement with Nordea
Biotie and Nordea Bank Finland Plc concluded a market making
agreement, which fulfils the requirements of NASDAQ OMX Helsinki
Ltd's Liquidity Providing (LP) operations. The market making
agreement aims at increasing the share's liquidity and decreasing the
share price volatility thus facilitating trading.
According to the agreement, Nordea will provide Biotie's share with
bids and offers so that the maximum spread is 4% calculated from the
bid quotation. Bids or offers include at least 4,000 shares and the
value of the shares must correspond to at least 4,000 euros.
Nordea undertakes to submit bids and offers for Biotie's share on the
official list in the trading system of NASDAQ OMX Helsinki on each
trading day for at least 85 per cent of the time of continuous
trading, at the opening and closing call of the trading day and in
the auction procedures applicable to the share during a trading day.
The market making in accordance with the agreement began on September
24, 2009. After a 6-month term, the market making agreement is valid
until further notice. The term of notice of the agreement is one
month.
Changes in ownership
Biotie has on February and July, 2009 gained knowledge of the
notifications regarding the following changes in holdings in
accordance with Chapter 2, Section 9 of the Finnish Securities
Markets Act
Information on notices of change in ownership are 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, 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 of 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.
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.
Events after the reporting period
The Company has entered into a Standby Equity Distribution Agreement
with YA Global Master SPV Ltd. ("YA Global") a fund managed by
Yorkville Advisors, LLC of Jersey City, New Jersey, USA
("Yorkville"). Under the terms of the agreement, Biotie has the
option, at the sole and exclusive discretion of the Company, to take
up YA Global's commitment to subscribe and pay for ordinary no-par
Biotie shares up to a total value of 20 million euro over a period of
36 months.
At any time during the 36 month commitment period, Biotie may require
YA Global to purchase newly issued Biotie shares or shares Biotie has
in its own possession by delivering an advance notice to YA Global
designating requested portion of the commitment amount to be taken
up. The maximum portion of the commitment amount to be used at a time
is 50,000 euro for the first tranche, 100,000 euro for the second
tranche and 300,000 euro for the subsequent tranches. The number of
shares issuable to YA Global shall, however, in no event cause the
aggregate number of shares beneficially owned by YA Global and its
affiliates to exceed 4.99% of the then issued shares. Further, in no
event shall the aggregate number of shares issued by Biotie to YA
Global exceed 9.9% of all outstanding shares of Biotie during a
rolling twelve month period unless Biotie ensures that all shares
issued despite exceeding the threshold are or will be admitted for
listing.
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 YA Global the
relevant advance notice, and may in no event be less than 85% of the
daily volume-weighted average price of Biotie shares on NASDAQ OMX
Helsinki Ltd. on the last trading day prior to such date of advance
notice ("Minimum Price"). Further, should the market price on certain
of the five trading days following the date of advance notice fall
below the Minimum Price, the pro rata subscription for such days will
not be executed unless YA Global decides to execute such subscription
at the Minimum Price.
The purpose of the Standby Equity Distribution Agreement is to secure
the financing of Biotie's working capital in the short and medium
term. In consideration of the committed standby equity Biotie will
pay to YA Global a one-time commitment fee of 200.000 euro, payable
in Biotie shares, as well as a structuring fee and a due diligence
fee.
Future outlook
- During 2009, Biotie will provide support to its license partner
Lundbeck for the ongoing phase III studies with Nalmefene in alcohol
dependence.
- Biotie will continue to perform two clinical studies with its
proprietary VAP-1 antibody in psoriasis and rheumatoid arthritis
patients in the course of 2009. Results of these studies will become
available in the first half of 2010.
- The company 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.
- In its collaboration with Wyeth on the discovery and development of
novel PDE10 inhibitors for the treatment of psychiatric disorders,
Biotie and its partner intend to identify further development
candidates.
- Due to the increased clinical trial activity it is foreseeable that
the company's R&D expenses (excluding the extraordinary impairment
costs) will increase in comparison to previous financial year. At the
same time, income will also be higher due to the additional income
generated through the company's newly acquired subsidiary. Overall,
negative cash flow from operational activities is expected to
moderately increase in comparison to previous financial year.
Next financial report
Biotie's financial statement release 2009 will be published on
February 26, 2010.
IFRS and Accounting principles
The 2009 interim report 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 as one
segment. The interim report has not been prepared in accordance with
IAS 34, Interim Financial Reporting.
Financial statements for the period from January 1, 2009 to September
30, 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 2009.
This interim report is unaudited.
In Turku, October 23, 2009
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.-
30.9.2009 30.9.2008 30.9.2009 30.9.2008 31.12.2008
EUR 3 months 3 months 9 months 9 months 12 months
1,000
Revenue 1,792 791 4,532 3,950 5,127
Research and -3,828 -1,076 -16,741 -6,276 -8,730
development
expenses
General and -804 -302 -2,703 -1,201 -2,020
administrative
expenses
Other operating 443 59 1,203 179 502
income
Other operating -29 -41 0
expense
Operating -2,426 -528 -13,750 -3,348 -5,121
profit/loss
Financial income 125 273 571 508 1,432
Financial expenses -215 -245 -759 -962 -1,864
Profit/loss before -2,516 -500 -13,938 -3,802 -5,553
taxes
Taxes 0 0 1,859 0 76
Net income/loss -2,516 -500 -12,079 -3,802 -5,477
Total -2,516 -500 -12,079 -3,802 -5,477
comprehensive
income of the
period
Net income/loss
attributable to
Parent company -2,516 -500 -12,079 -3,802 -5,477
shareholders
Total
comprehensive
income
attributable to:
Parent company -2,516 -500 -12,079 -3,802 -5,477
shareholders
Earnings per share -0.02 -0.01 -0.08 -0.04 -0.06
(EPS)
basic & diluted,
EUR
CONSOLIDATED STATEMENT OF FINANCIAL POSITION
(IFRS)
EUR 1,000 30.9.2009 30.9.2008 31.12.2008
Assets
Non-current assets
Intangible assets 7,194 707 10,352
Goodwill 379 0 379
Property, plant and equipment 2,782 350 2,792
Other shares 10 0 0
10,365 1,057 13,523
Current assets
Prepaid expenses 0 0 2,400
Available for sale investment 131 0 131
Investments held to maturity 6,000 18,300 18,500
Accounts receivables and other 1,642 1,181 1,512
receivables
Financial assets at fair value 3,028 0 0
through
profit or loss
Cash and cash equivalents 7,673 2,667 6,738
18,474 22,148 29,281
Total 28,839 23,205 42,804
Equity and liabilities
Shareholders' equity
Share capital 36,361 19,779 36,361
Reserve for invested unrestricted 980 980 980
equity
Retained earnings -37,073 -31,808 -31,754
Net income/loss -12,079 -3,802 -5,477
Shareholders' equity total -11,811 -14,852 110
Non-current liabilities
Provisions 143 0 121
Non-current financial liabilities 25,431 24,472 24,930
Pension benefit obligation 593 0 574
Other non-current liabilities 6,544 5,602 5,881
Non-current deferred revenues 1,849 3,035 2,966
Deferred tax liabilities 0 1,859
34,560 33,109 36,331
Current liabilities
Provisions 607 18 641
Pension benefit obligation 17 0 10
Current financial liabilities 209 143 144
Current deferred revenues 2,140 1,175 3,501
Accounts payable and other current 3,117 3,612 2,067
liabilities
6,090 4,948 6,363
Liabilities total 40,650 38,057 42,694
Total 28,839 23,205 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 90,212 19,850 980 -15 -31,930 -11,117
1.1.2008
Total -3,802 -3,802
comprehensive
income for the
period
Options granted 138 138
Cost of share -71 -71
issue
0 -71 0 0 -3,664 -3,735
BALANCE AT 90,212 19,779 980 -15 -35,594 -14,852
30.9.2008
Total -1,675 -1,675
comprehensive
income for the
period
Options granted 55 55
Share issue 54,109 16,873 16,873
Cost of share -291 -291
issue
54,109 16,582 0 0 -1,620 14,962
BALANCE AT 144,321 36,361 980 -15 -37,215 110
31.12.2008
Total -12,079 -12,079
comprehensive
income for the
period
Options granted 158 158
0 0 0 0 -11,921 -11,921
BALANCE AT 144,321 36,361 980 -15 -49,136 -11,811
30.9.2009
CONSOLIDATED STATEMENT OF CASH FLOWS
1.1.- 1.1.- 1.1.-
30.9.2009 30.9.2008 31.12.2008
EUR 1,000 9 months 9 months 12 months
Cash flow from operating Activities
Net income/loss -12,079 -3,802 -5,477
Adjustments:
Non-cash transactions 3,724 238 -4,303
Addition/disposal due to -28 0 0
revaluation
of financial assets at fair
value through profit or loss
Interest and other 775 962 1,863
financial expenses
Interest income -587 -508 -1,431
Taxes -1,859 0 -76
Change in working capital:
Change in accounts receivables and -48 -44 446
other receivables
Change in accounts payable and 1,039 -4,732 -277
other liabilities
Change in mandatory provisions -11 -15 -152
Interests paid -107 -5 -29
Interests received 430 39 66
Taxes paid -5 0 0
Net cash from operating activities -8,757 -7,867 -9,370
Cash flow from investing activities
Acquisition of subsidiary, net of cash 0 0 1,881
acquired
Change in financial assets at
fair value through profit or loss
Additions -3,000 0 0
Disposals 0 27,685 27,685
Change in investments held to maturity
Additions -900 -21,800 -46,300
Disposals 13,400 3,598 28,321
Investments to tangible assets -116 -28 -34
Net cash used in investing activities 9,384 9,456 11,553
Cash flow from financing activities
Payments from share issue 0 0 3,300
Share issue costs 0 -71 -362
Proceeds from borrowings 421 888 1,374
Repayment of loans -40 -40 -40
Repayment of lease -72 -4 -21
Commitments
Net cash from financing activities 309 774 4,250
Net increase (+) or decrease (-) 936 2,362 6,433
in cash and cash equivalents
Cash and cash equivalents in the 6,738 305 305
beginning of the period
Cash and cash equivalents in the 7,673 2,667 6,738
end of the period
Contingent liabilities
EUR 30.9.2009 30.9.2008 31.12.2008
1,000
Operating lease 124 146
commitments 123
Due within a year 81 69 64
Due later 43 77 59
Rent commitments 415 570 532
Due within a year 233 233 233
Due later 182 337 299
Total 539 716 655
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 September 30, 2009 Biotie had purchase commitments, primarily for
contract research work services, totaling EUR 7.3 million.
KEY FIGURES
1.1.- 1.1.- 1.1.-
30.9.2009 30.9.2008 31.12.2008
EUR 1,000 9 months 9 months 12 months
Business
development
Revenues 4,532 3,950 5,127
Personnel on average 81 35 42
Personnel at the end of period 83 34 80
Research and development costs 16,741 6,276 8,730
Capital expenditure 426 110 116
Profitability
Operating profit/loss -13,750 -3,348 -5,121
as percentage of revenues, % -303.4 -84.8 -99.9
Profit/loss before taxes -13,938 -3,802 -5,553
as percentage of revenues, % -307.5 -96.3 -108.3
Balance sheet
Cash and cash equivalents 16,701 20,967 25,238
Shareholders equity -11,811 -14,852 110
Balance sheet total 28,839 23,205 42,804
Financial ratios
Return on equity, % - - -
Return on capital employed, % -71.9 -33.9 -18.3
Equity ratio, % -41.0 -64.0 0.3
Gearing, % -75.7 -24.6 -148.5
Per share data
Earnings per share (EPS) basic & -0.08 -0.04 -0.06
diluted, EUR
Shareholders'equity per share, EUR -0.08 -0.17 0.0008
Dividend per share, EUR
Pay-out ratio, %
Effective dividend yield, %
P/E-ratio
Share price
Lowest share price, EUR 0.23 0.47 0.24
Highest share price, EUR 0.67 0.94 0.94
Average share price, EUR 0.38 0.67 0.51
End of period share price, EUR 0.58 0.48 0.26
Market capitalization 83.7 43.3 37.5
at the end of period MEUR
Trading of shares
Number of shares traded 29,903,949 8,542,915 15,350,613
As percentage of all 20.7 9.5 10.6
Adjusted weighted average 144,320,560 90,211,860 96,734,553
number of shares during the period
Adjusted number of shares 144,320,560 90,211,860 144,320,560
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
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