Biotie Therapies Oyj : Biotie financial statement report 1 January - 31 December 2012 BIOTIE THERAPIES CORP. Stock Exchange Release 28 February, 2013 at 9.00 a.m. Biotie financial statement report 1 January - 31 December 2012 Positive pipeline newsflow in 2012 supports future growth strategy Company Highlights October - December 2012 *Biotie's partner H.Lundbeck A/S received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending marketing authorization of Selincro(^TM). *Biotie reported top-line data from a Phase 2b study with tozadenant (SYN115) in Parkinson's disease (PD) patients experiencing levodopa related end of dose wearing off. The study met its primary endpoint of a statistically highly significant decrease in 'off' time vs. placebo, as well as demonstrating efficacy across multiple secondary endpoints. *Biotie reported top-line data from an investigator-initiated and US Department of Defense funded study with nepicastat (SYN117) in post-traumatic stress disorder. Treatment with nepicastat was not effective in relieving PTSD-associated symptoms when compared to placebo. Nepicastat was generally well tolerated and will continue to be developed for cocaine dependence. *Due to a lack of success in partnering efforts Biotie has fully impaired the carrying value of ronomilast on December 31, 2012. This resulted in a non-cash impairment charge of EUR 3.4 million in Q4/2012. *Biotie ended 2012 with cash, cash equivalents and short term investments of EUR 33.8 million (EUR 33.9 million, 31 December 2011). Key Financials Figures in brackets, unless otherwise stated, refer to the same period in the previous year (EUR million) for the period October - December 2012 *Revenues EUR 0.6 million (0.0). Revenues consisted of pre-agreed development funding from UCB. *Research and development costs EUR 7.2 million (5.6) *Financial result, continuing operations (Net loss) EUR -8.8* million (-3.2) *Cash flow from operating activities, continuing operations EUR -7.7 million (-4.4) *Earnings per share EUR -0.02 (-0.01) for the period January - December 2012 *Revenues EUR 4.8 million (1.0). Revenues consisted of pre-agreed development funding from UCB which was recognized in H2 2012 and periodization of previously received up-front payments from licensing agreements. *Research and development costs EUR 24.2 million (35.3) *Financial result, continuing operations (Net loss) EUR -25.6* million (-31.7**) *Cash flow from operating activities, continuing operations EUR -27.1 million (-18.8) *Earnings per share EUR -0.06 (-0.09) *Liquid assets at the end of period EUR 33.8 million (33.9) *Financial result for 2012 was impacted by a non-cash impairment charge of EUR 3.4 million for ronomilast. **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 financial statement release is unaudited. Liquid assets are comprised of cash, cash equivalents and investments held to maturity. Timo Veromaa, Biotie's President and CEO commented, "2012 was an exciting year for Biotie. We reported positive outcomes for two of our late stage pipeline products and further strengthened our financial position thanks to the support of our strategic partners and new and existing investors. We enter 2013 in a strong position with an alcohol dependence drug that once approved could potentially change the treatment landscape of alcohol dependence and an exciting novel product with robust Phase 2 data in Parkinson's disease where there has been a lack of innovation. We look forward to further significant milestones in the coming year including a decision from the European Commission on final approval of Selincro and launch of Selincro by our partner Lundbeck." Outlook for 2013 and key upcoming milestones Selincro (nalmefene): On December 14, 2012 Biotie's partner Lundbeck received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending marketing authorization of Selincro(^TM) (nalmefene; an opioid system modulator) for the reduction of alcohol consumption in adult patients with alcohol dependence who have a high level of alcohol consumption. The European Commission usually delivers its final decision on approval within 2-3 months of the CHMP recommendation. Subject to the Commission's final approval and completion of pricing and reimbursement discussions, Lundbeck expects to launch Selincro in a number of European markets by mid-2013. 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): Biotie has granted UCB Pharma S.A. a license for exclusive, worldwide rights to tozadenant. After the reporting period, February 26, 2013 Biotie announced that UCB has licensed worldwide exclusive rights to Biotie's tozadenant (SYN115). As a result, Biotie will receive a one-time fee payment of USD 20 million from UCB. In addition, the parties have amended their original licence agreement, such that Biotie will now conduct phase 3 development of tozadenant in return for additional payments from UCB relating to defined development, regulatory and commercialization milestones. SYN120: An oral, potent and selective antagonist of the 5-HT[6 ]receptor with dual receptor modulation potential against 5-HT2a 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): Biotie, in partnership with the U.S. National Institute of Drug Abuse (NIDA), will jointly investigate the safety and efficacy of nepicastat in the treatment of cocaine dependence. A Phase 2 trial is expected to start in Q1 2013. On 27 December 2012 Biotie reported that an investigator-initiated study with nepicastat in post-traumatic stress disorder (PTSD) did not meet its primary efficacy endpoint. Biotie will work with the study investigators to analyze and understand the data in more detail before deciding on next steps with nepicastat in PTSD. BTT-1023 (VAP-1 antibody): A first-in-class, fully human monoclonal antibody for inflammatory and fibrotic diseases. As BTT-1023 is a biologic the company has concluded that the best way to maximize the value of this program is with a partnership and partnering efforts are being prioritized. Biotie does not plan to enter into Phase 2 clinical studies without a partner. Following on the positive CHMP opinion for Selincro and positive top-line date for tozadenant, 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 Q2/2013. The Board of Directors proposal for handling of the loss The Board of Directors proposes that no dividend from the financial year 2012 will be paid, and that the loss of the parent company for the financial year EUR 12.9 million (FAS) will be carried forward to shareholders' equity. Conference call An analyst and media conference call will take place on 28 February 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: +1 212 444 0895 UK callers: +44(0)20 7136 2056 Finnish callers: +358(0)9 6937 9543 Access code: 8421066 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 After the reporting period on January 2, 2013 David Cook was appointed Chief Financial Officer (CFO) and a member of the Group's management team, effective February 25, 2013. David Cook reports to Timo Veromaa, President and Chief Executive Officer. In addition to his CFO role David Cook will also be responsible for Biotie's business development activities. Chris Piggott, Company's Chief Business Officer, retires but will continue as an advisor. After the reporting period, February 26, 2013 Biotie announced that UCB has licensed worldwide exclusive rights to Biotie's tozadenant (SYN115), As a result, Biotie will receive a one-time fee payment of USD 20 million from UCB. In addition, the parties have amended their original licence agreement, such that Biotie will now conduct phase 3 development of tozadenant in return for additional payments from UCB relating to defined development, regulatory and commercialization milestones. 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^TM (nalmefene), licensed to Lundbeck A/S, has on 14 December 2012 received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending marketing authorization of Selincro(TM) 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 has successfully completed a Phase 2b study in 420 patients with advanced Parkinson's disease. Biotie shares are listed on NASDAQ OMX Helsinki Ltd. Turku, 28 February 2013 Biotie Therapies Corp. Board of Directors For further information, please contact: Virve Nurmi, Investor Relations Manager tel. +358 2 274 8900 e-mail: email@example.com Distribution: NASDAQ OMX Helsinki Ltd Main media www.biotie.com Attachment: Biotie_Financial statement report 2012 Biotie_Financial statement report 2012 ------------------------------------------------------------------------------ This announcement is distributed by Thomson Reuters on behalf of Thomson Reuters clients. The owner of this announcement warrants that: (i) the releases contained herein are protected by copyright and other applicable laws; and (ii) they are solely responsible for the content, accuracy and originality of the information contained therein. Source: Biotie Therapies Oyj via Thomson Reuters ONE HUG#1681897
Biotie Therapies Oyj : Biotie financial statement report 1 January - 31 December 2012
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