Biotie Interim report 1 January - 30 September 2012
| Source:Biotie Therapies
BIOTIE THERAPIES CORP. Stock Exchange Release 2 November, 2012 at
Biotie Interim report 1 January - 30 September 2012
July - September 2012
* Biotie completed a directed share issue of EUR 20 million to institutional
and strategic investors.
* Lundbeck made a EUR 10 Million equity investment in Biotie with a 25%
premium and the parties amended the Selincro licensing agreement regarding
territories outside the EU and US.
* The total amount of funds raised in share issues amounts to EUR 30 million
and the total amount of new shares issued was 65,116,281 shares.
* Biotie completed enrollment in a Phase 2b trial evaluating the safety and
efficacy of tozadenant in Parkinson's disease. Biotie expects the top-line
data from this study to be available around the year end of 2012, previous
guidance was H1 2013.
* Biotie renewed the SEDA agreement with US fund Yorkville. Yorkville is under
certain pre-agreed terms and conditions obliged to subscribe and pay for
Biotie shares up to a total value of EUR 20 million during the agreement
period until November 2015 at Biotie's discretion.
* As a result of the EUR 20 million directed share issue and Lundbeck's EUR
10 million investment, Biotie ended the third quarter on 30 September 2012
with cash, cash equivalents and short term investments of EUR 41.7 million
(EUR 37.2 million, 30 September 2011).
Figures in brackets, unless otherwise stated, refer to the same period in the
previous year (EUR million)
for the period July - September 2012
* Revenues EUR 3.9 million (0.0). Revenues consisted of pre-agreed development
funding from UCB.
* Research and development costs EUR 4.5 million (20.4)
* Financial result (Net loss) EUR -2.4 million (-16.2*)
* Cash flow from operating activities, continuing operations EUR -3.5 million
* Earnings per share EUR -0.01 (-0.04)
for the period January-September 2012
* Revenues EUR 4.2 million (1.0). Revenues consisted of pre-agreed development
funding from UCB which was recognized in Q3 2012 and periodization of
previously received up-front payments from licensing agreements.
* Research and development costs EUR 17.0 million (29.7)
* Financial result (Net loss) EUR -16.8 million (-28.5*)
* Cash flow from operating activities, continuing operations EUR -19.4 million
* Earnings per share EUR -0.04 (-0.08)
* Liquid assets at the end of period EUR 41.7 million (37.2)
*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 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, "We had an extremely
productive third quarter and were delighted by the support and interest we
received from our partners and investors in the recent financial transactions.
We are now in a strong position as we near key commercial and clinical
milestones for the Company and in our discussions with potential partners.
During the coming months we expect the decision from the European authorities
on marketing authorization for Selincro in alcohol dependence, with Lundbeck,
top-line Phase 2b data with tozadenant in Parkinson's disease and Phase 2 data
with nepicastat in PTSD. We will not make significant new investments in our
pipeline before we have reached these significant inflection points. These are
very busy and exciting times for the Company and we look forward to updating you
on these important events shortly."
Outlook for 2012 and key upcoming milestones
Selincro (nalmefene): A marketing authorization application (MAA) for Selincro
for alcohol dependence, submitted by Biotie's partner Lundbeck, was accepted for
review by the European Medicines Agency (EMA) in December 2011. Feedback from
the authorities is expected H2 2012. Pending approval, the next milestone
payments to Biotie are expected on commercial launch of Selincro and on the
product reaching certain predetermined sales.
Tozadenant (SYN115): As announced on 5 July, 2012, enrollment has been completed
in a Phase 2b trial, funded by Biotie, evaluating the safety and efficacy of
tozadenant in Parkinson's disease patients. Top-line data from this study is
expected to be available around the end of 2012. UCB Pharma S.A. has a license
for exclusive, worldwide rights to tozadenant and, pending results of the
ongoing study will be responsible for conducting the Phase 3 program.
SYN120: An oral, potent and selective antagonist of the 5-HT(6 )receptor. 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): Phase 2 study ongoing, funded by the US Department of
Defense, for the treatment of post-traumatic stress disorder (PTSD); top-line
data are expected in H2 2012.
Under the agreement with the National Institute on Drug Abuse (NIDA) at the US
National Institutes of Health, NIDA and Biotie are jointly investigating the
safety and efficacy of nepicastat in the treatment of cocaine dependence. The
trial is expected to start in Q1 2013.
BTT-1023 (VAP-1 antibody): A first-in-class, fully human monoclonal antibody for
inflammatory and fibrotic diseases. BTT-1023 being a biologic the company has
concluded that the best way to maximize value of this program is with a
partnership and partnering efforts will now be prioritized. Biotie does not plan
to enter into Phase 2 clinical studies without a partner.
Ronomilast: A once-daily, potentially best-in-class oral phosphodiesterase-4
(PDE4) inhibitor with therapeutic potential in chronic inflammatory disorders,
including chronic obstructive pulmonary disease (COPD). Biotie is seeking a
partner for further development and commercialization of this product.
The company will not make significant new investments before feedback from EMA
on Selincro and the topline data from the tozadenant Phase 2b clinical study are
An analyst and media conference call will take place on 2 November 2012 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: +1 646 254 3360
UK callers: +44(0)20 7784 1036
Finnish callers: +358(0)9 6937 9590
Access code: 6489123
In case you need additional information or assistance, please contact: Virve
Nurmi, IR Manager, Tel: +358 2 2748 911
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.
Partnerships with top-tier pharmaceutical partners are in place for several
programs as well as a strategic collaboration with UCB Pharma S.A. The Marketing
Authorization Application for Biotie's most advanced product, SelincroTM
(nalmefene) for alcohol dependence was filed in the EU by our partner H.
Lundbeck A/S and was accepted for review by the European Medicines Agency in
Turku, 2 November 2012
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_Q3 2012 Interim report
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