Biotie Therapies - Interim report (Q1 and Q3)

Biotie interim report 1 January - 31 March 2014

BIOTIE THERAPIES CORP.      Interim Report
9 May, 2014 at 9.00 a.m.

Biotie interim report 1 January - 31 March 2014

This is a summary of the interim report 1 January - 31 March 2014 published
today. The complete report is attached to this release.

Company Highlights

January - March 2014

  * Biotie regained global rights to tozadenant (SYN115) from UCB Pharma S.A.
    (UCB). Tozadenant, a selective inhibitor of the adenosine 2a (A2a) receptor,
    has delivered clinically relevant and statistically highly significant
    effects in Parkinson's disease, across multiple pre-specified evaluation
    parameters, in a 420 patient Phase 2b study completed in December 2012. The
    End of Phase 2 Meeting with the US Food and Drug Administration took place
    in March and recruitment for the Phase 3 program for tozadenant is expected
    to start in H1 2015. Biotie is evaluating strategic options to finance
    tozadenant within its portfolio.
  * Biotie decided to progress SYN120 internally to the next stage of
    development and will not exercise its option to acquire Neurelis until
    further notice.
  * Biotie's revenue for 3 months ended 31 March 2014 was EUR 5.1 million (EUR
    15.3 million) and the financial result was a net loss of EUR 1.6 million
    (net income of EUR 10.0 million).
  * Biotie ended the first quarter on 31 March 2014 with cash, cash equivalents
    and short term investments of EUR 38.2 million (EUR 43.7 million, 31
    December 2013). Operating cash flow was EUR -5.4 million (EUR 10.2 million).

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

for the period January - March 2014

  * Revenues EUR 5.1 million (15.3).
  * Research and development costs EUR 4.7 million (3.1)
  * Financial result EUR -1.6 million (10.0)
  * Cash flow from operating activities EUR -5.4 million (10.2)
  * Earnings per share EUR -0.00 (0.02)
  * Liquid assets at the end of period EUR 38.2 million (44.7).
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, "There are exciting
opportunities ahead for Biotie as we focus on advancing our proprietary
pipeline.  During the first quarter we took the decision to advance our novel
5HT6/5HT2a receptor antagonist SYN120 towards clinical trials in Alzheimer's
disease. We believe its dual mechanism of action could result in improvements in
neuropsychiatric and cognitive elements of the disease that are currently poorly
treated with existing agents. In addition, we regained full rights to
tozadenant, enabling us to evaluate the most suitable development strategy for
this phase 3 ready asset, and we are evaluating strategic options to finance
tozadenant within our portfolio. The Phase 2 trial with our cocaine addiction
product nepicastat is on-going with results expected during the first half of
next year. We expect to start a Phase 2 trial with BTT-1023 in primary
sclerosing cholangitis toward the end of 2014 and be able to disclose details of
our negotiated co-funding for the study before that. Our cash resources, which
will increasingly be supported by royalty revenue from Selincro, enable us to
make decisions on our investment portfolio that will lay down solid foundations
for Biotie's future."

Outlook for 2014 and key upcoming milestones:

Selincro: Lundbeck will continue the rollout of Selincro in additional European
markets into 2014. Biotie is eligible for launch milestones in France, Germany
and Spain of EUR 2 million in each market, and further royalties on sales in all
markets. Due to the early phase of the launch of Selincro no guidance can be
given on expected royalty revenue in 2014. The first clinical Phase 3 study
under the joint Lundbeck/Otsuka development program in Japan is expected to be
initiated in 2014, but will not impact Biotie's financial results.

Tozadenant (SYN115): Following the decision by UCB Pharma to return global
rights to tozadenant, Biotie is evaluating the most suitable development
strategy for this Phase 3 ready asset to maximize its value to shareholders. The
Company considers tozadenant to be potentially its most valuable asset given the
therapeutic area and stage of development and is evaluating strategic options to
finance tozadenant within the portfolio. UCB has confirmed that it will meet all
its contractual and scientific commitments regarding the ongoing development
program for tozadenant, including conducting together with Biotie the scheduled
End-of-Phase 2 meeting with US Food and Drug Administration, which took place at
the end of March. The companies are working together to execute an appropriate
transfer of the program back to Biotie and UCB has committed to fully support
that transfer process and certain other activities, so that the Phase 3 clinical
studies can commence recruitment in H1 2015, as originally planned.

SYN120: Preparations have started for a Phase 2 study in Alzheimer's disease,
with the study expected to begin recruitment by the end of 2014.

Nepicastat (SYN117): A Phase 2 trial in cocaine dependence, funded by NIDA, is
continuing to recruit, and top-line data from the study is currently expected in
H1 2015.

BTT-1023: Preparations for a clinical Phase 2 study in primary sclerosing
cholangitis are ongoing. The Company is in advanced discussions for non-dilutive
co-funding for the study. The study is expected to start recruitment by the end
of 2014.

NRL-1:  Biotie has concluded that its timely access to market is not guaranteed
and that Biotie will not exercise the option to acquire Neurelis in H1 2014.
Biotie will not make any further significant investment into this opportunity
until further notice but will reassess its position based on recent market
information.

Strategic: The Company is currently in a solid financial position and all
preparations are ongoing for the phase 3 program with tozadenant to start
patient recruitment H1 2015 and for phase 2 studies with SYN120 and BTT-1023 to
start patient recruitment by the end of 2014. The Company considers tozadenant
to be potentially its most valuable asset given the therapeutic area and stage
of development and is evaluating strategic options to finance tozadenant within
the portfolio.

Financial: For the remainder of 2014, the Company expects further revenue from
Selincro, both milestones and royalties, and will incur further research and
development expenses in respect of tozadenant and SYN120 and BTT-1023.

Conference call

An analyst and media conference call will take place on 9 May 2014 at 2 p.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 3375
UK callers:  +44(0)20 3427 1925
Finnish callers: +358(0)9 2310 1618

Access code: 3619561

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

The Annual General Meeting of Biotie Therapies Corp. was held on 3 April 2014
and resolved the following items:

- The financial statements 2013 were adopted the result of the financial year
was booked.

- It was resolved to transfer the loss of the parent company to the unrestricted
equity of the company and no dividend shall be distributed.

- Discharge from liability the members of the Board of Directors and the
President and CEO

-The number of the members of the Board of Directors was resolved to be five.
The following current members of the Board of Directors William M. Burns, Merja
Karhapää, Bernd Kastler, Ismail Kola and Guido Magni were elected as the members
of the Board of Directors for a new term.

- It was resolved that the remuneration payable to the Chairman of the Board of
Directors shall be EUR 52,000 per year, to the Deputy Chairman of the Board of
Directors EUR 46,000 per year and to other Board members EUR 36,000 per year. In
addition, reasonable travelling expenses in connection with the meetings shall
be compensated. Further, separate meeting fees shall be paid to the Committees
of the Board of Directors: EUR 2,500 per meeting for the Chairman of the Audit
Committee, EUR 2,000 per meeting for the other Audit Committee members, EUR
2,000 per meeting for the Chairman of the Nomination and Remuneration Committee
and EUR 1,000 per meeting for other Nomination and Remuneration Committee
members.

- The number of auditors was resolved to be two. PricewaterhouseCoopers Oy, a
firm of Authorised Public Accountants, and Samuli Perälä Authorised Public
Accountant, were elected as auditors of the company. It was further resolved
that the auditors' fees shall be paid pursuant to a reasonable invoice.

- At the organization meeting of the new Board of Directors, which convened
immediately after the Annual General Meeting, William M. Burns was elected as
the Chairman of the Board of Directors. Bernd Kastler was elected as the
Chairman and Merja Karhapää and Guido Magni as the members of the Board's Audit
Committee and, in addition, William M. Burns as the Chairman and Ismail Kola and
Guido Magni as the members of the Nomination and Remuneration Committee. Based
on the evaluation of independence, the Board of Directors concluded that all
members of the Board of Directors are independent of the company and of its
significant shareholders.

- The General Meeting authorized the Board of Directors to resolve on one or
more issuances, 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 special
rights entitling to shares pursuant to Chapter 10 of the Companies Act. The
authorization consists of up to 95,000,000 shares in aggregate.

The authorization is effective until 30 June 2015 and it supersedes earlier
authorizations.

The stock exchange release regarding the resolutions of the Annual General
Meeting of Biotie was published on 3 April 2014.

About Biotie

Biotie is a specialized drug development company focused on products for
neurodegenerative and psychiatric disorders. For the past years, Biotie has
successfully operated a strategy built around search, profile and partner. This
has delivered Selincro (nalmefene) for alcohol dependence, which received
European marketing authorization in February 2013 and is currently being rolled
out across Europe by partner H. Lundbeck A/S, and tozadenant, a novel A2a
antagonist which is transitioning into Phase 3 development for Parkinson's
disease and for which Biotie holds exclusive, global rights. Biotie is actively
developing its pipeline assets, including SYN120, a unique potent 5-HT6/5-HT2a
dual antagonist for which Biotie expects to conduct a Phase 2 study in
Alzheimer's disease; nepicastat, a selective inhibitor of dopamine beta
hydroxylase which is currently in a Phase 2 study, fully funded by NIDA, for
treatment seeking cocaine addicts; and BTT-1023, a monoclonal antibody targeting
Vascular Adhesion Protein 1 for which Biotie intends to conduct a Phase 2 study
in primary sclerosing cholangitis, a rare fibrotic disease of the liver.
Biotie's shares are listed on NASDAQ OMX Helsinki.

Turku, 9 May 2014

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 2014


[HUG#1784033]

Attachments:

Biotie_Interim report Q1 2014_fin.pdf