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BioTie Therapies Corp. Interim Report 1 January - 30 June 2014

7/30/2014 2:40:35 PM

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This is a summary of the interim report 1 January - 30 June 2014 published today. The complete report is attached to this release.

Company Highlights April - June 2014

* Following the return of global rights to tozadenant, Biotie's adenosine A2a antagonist for Parkinson's disease, activities were ongoing to transfer the program back in-house and to prepare for clinical Phase 3 studies. Patient recruitment is expected to commence in H1 2015 as originally planned.
* Preparatory work was ongoing to advance SYN120, Biotie's 5-HT6/5-HT2a dual antagonist, and BTT1023, Biotie's monoclonal anti-vascular adhesion protein -1 antibody, into Phase 2 studies, with the BTT1023 program expected to commence patient recruitment by the end of 2014 and the SYN120 program around the end of 2014.
* Patient enrollment into the 179-patient Phase 2 study investigating nepicastat for cocaine dependence completed ahead of schedule. Top-line results from the study are expected around the end of 2014.
* Biotie's revenue in Q2 2014 was EUR 0.8 million (EUR 2.1 million) and the financial result was a net loss of EUR 3.7 million (net loss of EUR 4.0 million).
* Biotie ended the second quarter on 30 June 2014 with liquid assets of EUR 34.0 million (EUR 38.2 million, 31 March 2014). Operating cash flow was a net outflow of EUR 4.3 million (net inflow of EUR 0.5 million).

Key Financials

Figures in brackets, unless otherwise stated, refer to the same period in the previous year (EUR million) for the period April - June 2014

* Revenues EUR 0.8 million (2.1)
* Research and development costs EUR 2.8 million (3.3)
* Net profit (loss) EUR -3.7 million (-4.0)
* Cash flow from operating activities EUR -4,3 million (0,5)
* Earnings per share EUR -0.01 (-0.01)

for the period January - June 2014

* Revenues EUR 5.9 million (17.4)
* Research and development costs EUR 7.5 million (6.3)
* Net profit (loss) EUR -5.3 million (6.0)
* Cash flow from operating activities EUR -9.6 million (10.7) * Earnings per share EUR -0.01 (0.01)
* Liquid assets at the end of period EUR 34.0 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, "We are now fully in control of the path forward for tozadenant. The data we have reported so far is strong and we believe this product has the potential to offer meaningful clinical benefit to patients with Parkinson's disease. We also made steady progress with our Phase 2 assets: NIDA completed recruitment earlier than expected in the SYN117 cocaine addiction study and we were pleased to receive funding from The Michael J. Fox Foundation, after the quarter, to investigate SYN120 in Parkinson's dementia where its dual mechanism of action could play an important role in managing cognition. In the near term our focus will be on execution as we prepare to start Phase 3 trials with tozadenant in H1 2015. We await headline data from the SYN117 study in cocaine dependence around end-2014, at the same time as a Phase 2 clinical trial should begin for SYN120 in Parkinson's dementia. For our VAP-1 antibody, BTT1023, we also expect a Phase 2 study in primary sclerosing cholangitis to commence later in the year".

Outlook for 2014 and key upcoming milestones:

Selincro (nalmefene): Lundbeck will continue the rollout of Selincro in additional European markets during 2014. Biotie is eligible for launch milestones in France, Germany and Spain of EUR 2 million in each market, of which Biotie became eligible to the EUR 2 million for Spain on 22 July, 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): Biotie considers tozadenant to potentially be its most valuable asset given the high unmet medical need in Parkinson's disease and stage of development. Following the decision by UCB Pharma to return global rights to tozadenant in March 2014, Biotie has been evaluating the most suitable development strategy for this Phase 3 ready asset to maximize its value to shareholders and has concluded that this can be best achieved by continuing with the Phase 3 study within its current portfolio. Biotie is currently evaluating various options, which may include a capital increase, to support the clinical studies and a strong regulatory filing package for tozadenant.

Phase 3 development work has continued as planned for tozadenant and Biotie is working with UCB to execute the full transfer of the program back to Biotie, so that the Phase 3 clinical studies can commence recruitment in H1 2015, as originally planned. SYN120: As announced in early July, the company has received a USD 2.0 million (EUR 1.5 million) grant from The Michael J. Fox Foundation (MJFF) for a Phase 2 study in Parkinson's disease dementia, which is expected to begin recruitment around the end of 2014.

As a result of this grant and the decision on tozadenant, the previously planned Phase 2 study in Alzheimer's disease will not begin recruitment by the end of 2014 and will be assessed based on the development status of the other products within the portfolio.

Nepicastat (SYN117): The Phase 2 trial in cocaine dependence, funded by NIDA, completed patient enrolment in June, ahead of schedule. The top-line results from the study are expected around the end of 2014.

BTT1023: Preparations for a clinical Phase 2 study in primary sclerosing cholangitis are ongoing. In July, the company announced that the discussions for non-dilutive co-funding for the study had concluded and that the study would receive a grant of approximately EUR 1 million. The study is expected to start recruitment by the end of 2014.

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, a Phase 2 study with SYN120 to start patient recruitment around the end of 2014 and a Phase 2 study with BTT1023 to start patient recruitment by the end of 2014. The Company has concluded that it can best maximize the value of tozadenant by continuing its development within the current portfolio and is considering various options to finance this development.

Financial: For the remainder of 2014, the Company expects further revenue from Selincro, both milestones and royalties. Further research and development expenses will be incurred in respect of tozadenant, SYN120 and BTT1023.

Conference call

An analyst and media conference call will take place on 30 July 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 An on demand version of the conference will be published on Biotie's website later during the day

Telephone conference numbers:
US callers:
+1718 354 1357
UK callers: +44(0)20 3364 5381
Finnish callers: +358(0)9 6937 9590
Access code: 6058081

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

Biotie announced on 8 July 2014 that it signed a USD 2 million research contract with The Michael J. Fox Foundation (MJFF) to investigate SYN120 in Parkinson's disease patients with dementia. MJFF will fund an 80-patient Phase 2 trial which will be conducted by the Parkinson Study Group at approximately 10 US sites specializing in cognitive dysfunction in Parkinson's disease.

Biotie announced on 8 July 2014 that full data from the positive Phase 2b study evaluating tozadenant, an adenosine A2a antagonist, in Parkinson's disease patients experiencing end of dose wearing off was published in Lancet Neurology (Hauser RA, Olanow CW, Kieburtz KD, et al. Tozadenant (SYN115) in patients with Parkinson's disease who have motor fluctuations on levodopa: a phase 2b, double- blind, randomised trial. Lancet Neurol 2014; published online July 7).

Biotie announced on 10 July 2014 that the National Institute for Health and Care Excellence (NICE), the United Kingdom's health technology assessment authority, issued draft guidance recommending the use of Selincro (nalmefene) within the conditions of its marketing authorization in the National Health Service (NHS) in England. The draft guidance is open for comments until July 29, and final guidance is expected in November 2014.

Biotie announced on 11 July 2014 that it decided not to exercise its exclusive option to acquire Neurelis, Inc. (Neurelis), a private specialty pharmaceutical company. In consideration of the timely transfer of the program to Neurelis, Biotie and Neurelis have agreed that Biotie may recover the cost of its investment to date in Neurelis' lead product NRL-1 through a share of future revenue generated by Neurelis. Neurelis plans to commence the remaining development program and proceed with clinical trials which have been agreed with the FDA. NRL-1 is a proprietary intranasal formulation of diazepam for pediatric and adult epilepsy patients who experience acute repetitive seizures.

Biotie announced on 22 July that Lundbeck has launched Selincro in Spain. As a result, Biotie will receive a EUR 2 million launch milestone.

Biotie announced on 24 July that the discussions for non-dilutive co-funding for a clinical Phase 2 study with BTT1023 in primary sclerosing cholangitis had concluded and that the study would receive a grant of approximately EUR 1 million.

Biotie announced on 30 July that the Company has conveyed Biotie shares held as treasury shares and that were issued on 2 January 2014 pursuant to the Stock Option Plan 2011 (766,750 shares conveyed) and the Equity Incentive Plan 2011 (1,046,160 shares conveyed). Further, it has issued 15,770 Biotie shares held as treasury shares under the Swiss Option Plan. As a result of the conveyances, the total number of votes attached to Biotie's shares increased to 449,515,822 and the total number of shares held by the Company or its fully owned subsidiary is 6,516,576 shares. The conveyances do not affect the number of registered shares (456,032,398).

About Biotie

Biotie is a specialized drug development company focused on products for neurodegenerative and psychiatric disorders. Biotie's development has delivered Selincro (nalmefene) for alcohol dependence, which received European marketing authorization in 2013 and is currently being rolled out across Europe by partner Lundbeck. The current development products include tozadenant for Parkinson's disease, which is transitioning into Phase 3 development, and three additional compounds which are in Phase 2 development for cognitive disorders including Parkinson's disease dementia, cocaine dependence, and primary sclerosing cholangitis (PSC), a rare fibrotic disease of the liver.

Turku, 30 July 2014

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
Main media

Attachment: Biotie_interim report Q2 2014

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