2013-02-28 08:15:25 -
BIOTIE THERAPIES CORP. Stock Exchange Release 28 February, 2013 at
Biotie financial statement report 1 January - 31 December 2012
Positive pipeline newsflow in 2012 supports future growth strategy
October - December 2012
* Biotie's partner H.Lundbeck A/S received a positive opinion from the
Committee for Medicinal Products for Human Use (CHMP) of the European
Medicines Agency (EMA) recommending marketing authorization of
* Biotie reported top-line data from a Phase 2b study with tozadenant (SYN115)
in Parkinson's disease (PD) patients experiencing levodopa related end of
dose wearing off. The study met its primary endpoint of a statistically
highly significant decrease in 'off' time vs. placebo, as well as
demonstrating efficacy across multiple secondary endpoints.
* Biotie reported top-line data from an investigator-initiated and US
Department of Defense funded study with nepicastat (SYN117) in post-
traumatic stress disorder. Treatment with nepicastat was not effective in
relieving PTSD-associated symptoms when compared to placebo. Nepicastat was
generally well tolerated and will continue to be developed for cocaine
* Due to a lack of success in partnering efforts Biotie has fully impaired the
carrying value of ronomilast on December 31, 2012. This resulted in a non-
cash impairment charge of EUR 3.4 million in Q4/2012.
* Biotie ended 2012 with cash, cash equivalents and short term investments of
EUR 33.8 million (EUR 33.9 million, 31 December 2011).
Figures in brackets, unless otherwise stated, refer to the same period in the
previous year (EUR million)
for the period October - December 2012
* Revenues EUR 0.6 million (0.0). Revenues consisted of pre-agreed development
funding from UCB.
* Research and development costs EUR 7.2 million (5.6)
* Financial result, continuing operations (Net loss) EUR -8.8* million (-3.2)
* Cash flow from operating activities, continuing operations EUR -7.7 million
* Earnings per share EUR -0.02 (-0.01)
for the period January - December 2012
* Revenues EUR 4.8 million (1.0). Revenues consisted of pre-agreed development
funding from UCB which was recognized in H2 2012 and periodization of
previously received up-front payments from licensing agreements.
* Research and development costs EUR 24.2 million (35.3)
* Financial result, continuing operations (Net loss) EUR -25.6* million (-
* Cash flow from operating activities, continuing operations EUR -27.1 million
* Earnings per share EUR -0.06 (-0.09)
* Liquid assets at the end of period EUR 33.8 million (33.9)
*Financial result for 2012 was impacted by a non-cash impairment charge of EUR
3.4 million for ronomilast.
**Financial result for 2011 was impacted by a non-cash impairment charge of EUR
11.7 million for SYN118.
The group's financial position was strengthened by EUR 30 million equity raise
in September 2012.
The financial statement release is unaudited. Liquid assets are comprised of
cash, cash equivalents and investments held to maturity.
Timo Veromaa, Biotie's President and CEO commented, "2012 was an exciting year
for Biotie. We reported positive outcomes for two of our late stage pipeline
products and further strengthened our financial position thanks to the support
of our strategic partners and new and existing investors. We enter 2013 in a
strong position with an alcohol dependence drug that once approved could
potentially change the treatment landscape of alcohol dependence and an exciting
novel product with robust Phase 2 data in Parkinson's disease where there has
been a lack of innovation. We look forward to further significant milestones in
the coming year including a decision from the European Commission on final
approval of Selincro and launch of Selincro by our partner Lundbeck."
Outlook for 2013 and key upcoming milestones
Selincro (nalmefene): On December 14, 2012 Biotie's partner Lundbeck received a
positive opinion from the Committee for Medicinal Products for Human Use (CHMP)
of the European Medicines Agency (EMA) recommending marketing authorization of
Selincro((TM)) (nalmefene; an opioid system modulator) for the reduction of
alcohol consumption in adult patients with alcohol dependence who have a high
level of alcohol consumption.
The European Commission usually delivers its final decision on approval within
2-3 months of the CHMP recommendation. Subject to the Commission's final
approval and completion of pricing and reimbursement discussions, Lundbeck
expects to launch Selincro in a number of European markets by mid-2013.
Pending approval, the next milestone payments to Biotie are expected on
commercial launch of Selincro and on the product reaching certain predetermined
Tozadenant (SYN115): Biotie has granted UCB Pharma S.A. a license for exclusive,
worldwide rights to tozadenant. After the reporting period, February 26, 2013
Biotie announced that UCB has licensed worldwide exclusive rights to Biotie's
tozadenant (SYN115). As a result, Biotie will receive a one-time fee payment of
USD 20 million from UCB. In addition, the parties have amended their original
licence 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.
SYN120: An oral, potent and selective antagonist of the 5-HT(6 )receptor with
dual receptor modulation potential against 5-HT2a 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 in Q1 2013.
On 27 December 2012 Biotie reported that an investigator-initiated study with
nepicastat in post-traumatic stress disorder (PTSD) did not meet its primary
efficacy endpoint. Biotie will work with the study investigators to analyze and
understand the data in more detail before deciding on next steps with nepicastat
BTT-1023 (VAP-1 antibody): A first-in-class, fully human monoclonal antibody for
inflammatory and fibrotic diseases. 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. Biotie does not plan
to enter into Phase 2 clinical studies without a partner.
Following on the positive CHMP opinion for Selincro and positive top-line date
for tozadenant, 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 expects to report on the results of this
review during Q2/2013.
The Board of Directors proposal for handling of the loss
The Board of Directors proposes that no dividend from the financial year 2012
will be paid, and that the loss of the parent company for the financial year EUR
12.9 million (FAS) will be carried forward to shareholders' equity.
An analyst and media conference call will take place on 28 February 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
Telephone conference numbers:
US callers: +1 212 444 0895
UK callers: +44(0)20 7136 2056
Finnish callers: +358(0)9 6937 9543
Access code: 8421066
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
After the reporting period on January 2, 2013 David Cook was appointed Chief
Financial Officer (CFO) and a member of the Group's management team, effective
February 25, 2013. David Cook reports to Timo Veromaa, President and Chief
Executive Officer. In addition to his CFO role David Cook will also be
responsible for Biotie's business development activities. Chris Piggott,
Company's Chief Business Officer, retires but will continue as an advisor.
After the reporting period, February 26, 2013 Biotie announced that UCB has
licensed worldwide exclusive rights to Biotie's tozadenant (SYN115), As a
result, Biotie will receive a one-time fee payment of USD 20 million from UCB.
In addition, the parties have amended their original licence 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
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 14 December 2012 received a positive opinion from the Committee for
Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA)
recommending marketing authorization of Selincro(TM) 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 has successfully completed a
Phase 2b study in 420 patients with advanced Parkinson's disease. Biotie shares
are listed on NASDAQ OMX Helsinki Ltd.
Turku, 28 February 2013
Biotie Therapies Corp.
Board of Directors
For further information, please contact:
Virve Nurmi, Investor Relations Manager
tel. +358 2 274 8900
NASDAQ OMX Helsinki Ltd
Biotie_Financial statement report 2012
Biotie_Financial statement report 2012:
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