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

Biotie_Interim report Q1 2014_fin


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Source: Biotie Therapies Oyj via Globenewswire
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