BIOTIE THERAPIES CORP. Stock Exchange Release 2 August, 2013 at 9.00
a.m.
Biotie interim report 1 January - 30 June 2013;
Company Highlights
April - June 2013
* Biotie obtained an exclusive option to acquire Neurelis, Inc., a private
specialty pharmaceutical company based in San Diego, CA, focused on
developing products for epilepsy and other disorders of the central nervous
system.
* Biotie's partner H. Lundbeck A/S (Lundbeck) launched Selincro((R)), a new
treatment for alcohol dependent patients, in the first European markets. By
the end of June, Selincro was available in more than 10 EEA countries. The
quarter's revenues include a milestone payment of EUR 2 million following
the UK launch in May and royalties of EUR 0.07 million in relation to sales
made by Lundbeck during the quarter.
* Biotie announced the start of a Phase 2 clinical study evaluating nepicastat
(SYN117) in cocaine dependence. The National Institute on Drug Abuse (NIDA)
at the US National Institutes of Health is funding the conduct of the study.
* Biotie's financial result in Q2 2013 was a net loss of EUR 4.0 million; the
financial result for 6 months ended 30 June 2013 was a net income of EUR
6.0 million.
* Biotie ended the second quarter on 30 June 2013 with cash, cash equivalents
and short term investments of EUR 44.7 million (EUR 44.7 million, 31 March
2013).
Key Financials
Figures in brackets, unless otherwise stated, refer to the same period in the
previous year (EUR million)
for the period April - June 2013
* Revenues EUR 2.1 million (0.3).
* Research and development costs EUR 3.3 million (6.7 )
* Financial result EUR -4.0 million (-7.0)
* Cash flow from operating activities EUR 0.5 million (-6.7)
* Earnings per share EUR -0.01 (-0.02)
for the period January - June 2013
* Revenues EUR 17.4 million (0.4). Revenues consisted of the one-time
milestone payment from UCB; and the UK launch milestone and royalties for
Selincro from Lundbeck.
* Research and development costs EUR 6.3 million (12.5)
* Financial result EUR 6.0 million (-14.5)
* Cash flow from operating activities EUR 10.7 million (-15,9)
* Earnings per share EUR 0.01 (-0.04)
* Liquid assets at the end of period EUR 44.7 million (18.5)
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, "This has been an important
quarter for Biotie as we witnessed the initial rollout of our first commercial
product Selincro, for alcohol dependence, by our partner Lundbeck. We also
purchased an option to acquire Neurelis Inc., a private CNS focused company,
which brings with it NRL-1, a niche intranasal product for epileptic seizures
that represents an exciting potential development opportunity for Biotie. We are
currently in the process of further assessing NRL-1 and our proprietary programs
as part of our ongoing portfolio review and we expect to provide an update on
that during Q3 this year."
Outlook for 2013 and key upcoming milestones
Selincro (nalmefene): Further to the launch of Selincro by Lundbeck in the first
European markets in April 2013 and the subsequent launch in the UK in May 2013,
for which Biotie received a milestone of EUR 2 million, Lundbeck will continue
to launch Selincro in additional European markets through 2013 and into 2014.
This is planned to include launches in Italy, Germany, Spain and France, for
which Biotie would receive additional milestones of EUR 2 million in each
market; some of these may occur in 2013. In addition, Biotie will continue to
receive royalties on sales in all launched markets and make a contribution to
Lundbeck towards any required post approval commitments studies, neither of
which are expected to have a significant financial impact in 2013.
Tozadenant (SYN115): Biotie has granted UCB a license for exclusive, worldwide
rights to tozadenant. Biotie and UCB 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, some of which may be
received in 2013, are not likely to have a significant impact on the
profitability of Biotie over the duration of the clinical development.
Neurelis (NRL-1): In June, 2013 Biotie obtained an exclusive option to acquire
Neurelis, Inc., a private specialty pharmaceutical company, focused on
developing products for epilepsy and other disorders of the central nervous
system. Neurelis' lead product, NRL-1, is a proprietary intranasal formulation
of diazepam which is being developed to help patients with epilepsy who require
intermittent use of diazepam to manage bouts of acute and repetitive seizures.
Under the terms of the option and merger agreement, Biotie has made a payment of
US$1.0 million to Neurelis for the exclusive right, but not the obligation, to
acquire all of the outstanding shares of Neurelis for a pre-defined amount of
US$8.75 million, subject to certain adjustments, to be paid in new shares of
Biotie to be issued on approval by the Board of Directors. Biotie may exercise
the option right up until the start of the pivotal pharmacokinetic clinical
studies that will form the basis of a 505 (b)(2) New Drug Application (but no
later than December 3, 2014). This is expected in approximately 12-18 months'
time.
In the meantime, Biotie is responsible for the development of NRL-1, which
primarily includes further manufacturing and pre-clinical work which Biotie is
currently conducting.
SYN120: Biotie has generated an extensive clinical and preclinical data package
for SYN120 and the compound is ready to enter Phase 2. Biotie is currently
seeking a partnership for late stage clinical trials and has received interest
from several parties.
Nepicastat (SYN117): Biotie, in partnership with the U.S. National Institute of
Drug Abuse (NIDA), is jointly investigating the safety and efficacy of
nepicastat in the treatment of cocaine dependence. A Phase 2 trial started in
May 2013 and is expected to take approximately two years to complete.
BTT-1023 (VAP-1 antibody): Biotie is currently seeking a partner to best
maximize the value of BTT-1023.
Financial: While the company has recorded a net income for the six month period
ended 30June 2013, this was primarily due to the timing of a one-off milestone
payment in relation to tozadenant in the first quarter. Given that the size and
timing of such milestone payments cannot be predicted, this period'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 expects to report on the results of this
review during Q3 2013.
Conference call
An analyst and media conference call will take place on Friday 2 August 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: +1 646 254 3367
UK callers: +44 (0)20 3427 1913
Finnish callers: +358 (0)9 6937 9590
Access code: 5758079
In case you need additional information or assistance, please contact: Virve
Nurmi, IR Manager, Tel: +358 2 2748 911
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(R) (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, 2 August 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 Q2 2013
[HUG#1720584]
