Biotie Therapies Oyj : Biotie interim report 1 January - 31 March 2013

    Biotie Therapies Oyj : Biotie interim report 1 January - 31 March 2013

BIOTIE THERAPIES CORP.    Stock Exchange Release   3 May, 2013 at 9.00
a.m.

Biotie interim report 1 January - 31 March 2013;
important clinical and regulatory milestones achieved

Company Highlights
January - March 2013

  *Biotie' s partner H. Lundbeck A/S (Lundbeck) received European marketing
    authorization from the European Commission for Selincro for the reduction
    of alcohol consumption in adult patients with alcohol dependence. The
    marketing authorization applies to all 27 European Union member states.

  *UCB Pharma S.A (UCB) licensed worldwide exclusive rights to Biotie's
    tozadenant. As a result, Biotie received a one-time milestone payment of
    USD 20 million from UCB. In addition, the parties amended their original
    license agreement, such that Biotie will now conduct phase 3 development
    of tozadenant in return for additional payments from UCB relating to
    defined development, regulatory and commercialization milestones. The
    additional milestones under the revised agreement, and Biotie being
    responsible for conducting phase 3 development of tozadenant, are not
    likely to have a significant impact on the profitability of Biotie during
    the duration of the clinical development.

  *David Cook was appointed Chief Financial Officer (CFO) and a member of the
    Group's management team, effective 25 February 2013.

  *Biotie's financial result in Q1 2013 was a net income of EUR 10.0 million,
    mainly due to the one-time milestone payment by UCB which was recognized
    as revenue in the quarter.

  *Biotie ended the first quarter on 31 March 2013 with cash, cash
    equivalents and short term investments of EUR 44.7 million (EUR 33.8
    million, 31 December 2012).

Key Financials
Figures in brackets, unless otherwise stated, refer to the same period in the
previous year (EUR million)

for the period January - March 2013

  *Revenues EUR 15.3 million (0.0). Revenues consisted of the one-time
    milestone payment from UCB which was recognized as revenue in the first
    quarter.

  *Research and development costs EUR 3.1 million (5.8 )

  *Financial result EUR 10.0 million (-7.5)

  *Cash flow from operating activities, continuing operations EUR 10.2
    million (-9.3)

  *Earnings per share EUR 0.02 (-0.02 )

  *Liquid assets at the end of period EUR 44.7 million (24.7) 

The interim report is unaudited. Liquid assets are comprised of cash, cash
equivalents and investments held to maturity.

Timo Veromaa, Biotie's President and CEO commented, "The first quarter was
marked by two important developments for Biotie: the approval of Selincro in
Europe, the first and only product labeled for reduction of alcohol intake,
and a continued commitment from our partner UCB Pharma to advance our novel
A2A receptor antagonist - tozadenant - for Parkinson's disease into Phase 3
trials. We are now focused on developing the Phase 3 program for tozadenant
with UCB and on reviewing our pipeline as part of an ongoing portfolio review
to ensure we are investing in products with the greatest opportunity to create
value for Biotie and its shareholders going forward."

Outlook for 2013 and key upcoming milestones 

Selincro (nalmefene): After the reporting period, on 22 April 2013 Biotie
announced that its partner H.Lundbeck A/S has started launching Selincro on
the first European markets, making the new treatment available to alcohol
dependent patients in Norway, Finland, Poland and the Baltic countries.
Lundbeck will continue the rollout of Selincro in Europe through 2013 and into
2014.

According to the terms of the license agreement between Biotie and Lundbeck
for Selincro, Biotie is eligible for milestone payments upon commercial launch
of Selincro in France, Germany, Italy, Spain, and the United Kingdom, some of
which may occur in 2013; royalties on sales in all launched markets, which are
not expected to give rise to significant revenue in 2013; and a potential
contribution to Lundbeck towards any required post approval commitments
studies, which are not expected to be significant in 2013.

Tozadenant (SYN115): Biotie has granted UCB Pharma S.A. a license for
exclusive, worldwide rights to tozadenant. UCB and Biotie will collaborate on
the on-going clinical development of tozadenant and UCB will be responsible
for the manufacture and commercialization of tozadenant. Biotie will conduct
phase 3 development in return for payments from UCB relating to defined
development, regulatory and commercialization milestones. Patient enrollment
in the phase 3 program is currently planned to commence by the first half of
2015.

The additional payments from UCB for conducting phase 3 development of
tozadenant, are not likely to have significant impact on profitability of
Biotie over the duration of the clinical development.

SYN120: SYN120 has an extensive clinical and preclinical data package and is
ready to enter Phase 2. Biotie is seeking a partner for further development
and commercialization of this product.

Nepicastat (SYN117): Biotie, in partnership with the U.S. National Institute
of Drug Abuse (NIDA), will jointly investigate the safety and efficacy of
nepicastat in the treatment of cocaine dependence. A Phase 2 trial is expected
to start imminently.

BTT-1023 (VAP-1 antibody): As BTT-1023 is a biologic the company has concluded
that the best way to maximize the value of this program is with a partnership
and partnering efforts are being prioritized.

Financial: While the company has recorded a net income for the quarter ended
31 March 2013, this was due to the timing of a one-off milestone payment in
relation to tozadenant. Given that the size and timing of such milestone
payments cannot be predicted, this quarter's performance should not be taken
as indicative of future quarterly performance.

Portfolio review: Biotie is undertaking a portfolio review to ensure
appropriate prioritization of projects that have the best development
potential and provide the best opportunities of enhancing shareholder value.
The review will comprise both Biotie's internal development pipeline as well
as certain potential new strategic opportunities. The company now expects to
report on the results of this review during Q3 2013, as it is taking longer
than initially expected to complete.

Conference call

An analyst and media conference call will take place on Friday 3 May 2013 at
10:00 a.m. Central European Time. The conference call will be held in English.

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

Telephone conference numbers:

US callers: +1646 254 3360
UK callers: +44(0)20 7136 2050
Finnish callers: +358(0)9 6937 9590

Access code: 1047561

In case you need additional information or assistance, please contact: Virve
Nurmi, IR Manager, Tel: +358 2 2748 911

Key events after the reporting period

Biotie announced on 22 April 2013 that its partner H.Lundbeck A/S (Lundbeck)
has started launching Selincro(^TM) in the first European markets, making the
new treatment available to alcohol dependent patients in Norway, Finland,
Poland and the Baltic countries. The launch marks the first introduction of a
new treatment for alcohol dependence in Europe for more than a decade.
Lundbeck will continue the rollout of Selincro in Europe through 2013 and into
2014.

According to the terms of the license agreement between Biotie and Lundbeck
for Selincro, Biotie is eligible for milestone payments upon commercial launch
of Selincro in France, Germany, Italy, Spain, and the United Kingdom, some of
which may occur in 2013; royalties on sales in all launched markets, which are
not expected to give rise to significant revenue in 2013; and a potential
contribution to Lundbeck towards any required post approval commitments
studies, which are not expected to be significant in 2013.

About Biotie

Biotie is a specialized drug development company focused on the development of
drugs for neurodegenerative and psychiatric disorders (e.g. Parkinson's
disease, Alzheimer's disease and other cognitive disorders, alcohol and drug
dependence (addiction) and post-traumatic stress disorder), and inflammatory
and fibrotic liver disease. The company has a strong and balanced development
portfolio with 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.

Biotie's most advanced product, Selincro^TM (nalmefene), licensed to Lundbeck
A/S, has on 28 February 2013 received European marketing authorization for
the reduction of alcohol consumption in adult patients with alcohol dependence
who have a high level of alcohol consumption. In addition, Biotie has a
strategic collaboration with UCB Pharma S.A. covering tozadenant which is
transitioning into Phase 3 development for Parkinson's disease. Biotie shares
are listed on NASDAQ OMX Helsinki Ltd.

Turku, 3 May 2013

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

Attachment:
Biotie_interim report Q1 2013

Biotie_interim report Q1 2013

------------------------------------------------------------------------------

This announcement is distributed by Thomson Reuters on behalf of Thomson
Reuters clients.

The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and other
applicable laws; and
(ii) they are solely responsible for the content, accuracy and originality of
the
information contained therein.

Source: Biotie Therapies Oyj via Thomson Reuters ONE
HUG#1698727
 
Press spacebar to pause and continue. Press esc to stop.