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2012-11-02 08:00:00 CET 2012-11-02 08:01:05 CET REGULATED INFORMATION Biotie Therapies - Interim report (Q1 and Q3)Biotie Interim report 1 January - 30 September 2012BIOTIE THERAPIES CORP. Stock Exchange Release 2 November, 2012 at 9.00 a.m. Biotie Interim report 1 January - 30 September 2012 Company Highlights 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). Key Financials 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 (-3.8) * 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 (-14.3) * 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 available. Conference call 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 day 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 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. 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 December 2011. 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 e-mail: virve.nurmi@biotie.com Distribution: NASDAQ OMX Helsinki Ltd Main media www.biotie.com Attachment: Biotie_Q3 2012 Interim report [HUG#1654446] |
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