Biotie Therapies Oyj : Biotie interim report 1 January - 31 March 2013 BIOTIE THERAPIES CORP. Stock Exchange Release 3 May, 2013 at 9.00 a.m. Biotie interim report 1 January - 31 March 2013; important clinical and regulatory milestones achieved Company Highlights January - March 2013 *Biotie' s partner H. Lundbeck A/S (Lundbeck) received European marketing authorization from the European Commission for Selincro for the reduction of alcohol consumption in adult patients with alcohol dependence. The marketing authorization applies to all 27 European Union member states. *UCB Pharma S.A (UCB) licensed worldwide exclusive rights to Biotie's tozadenant. As a result, Biotie received a one-time milestone payment of USD 20 million from UCB. In addition, the parties amended their original license 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. The additional milestones under the revised agreement, and Biotie being responsible for conducting phase 3 development of tozadenant, are not likely to have a significant impact on the profitability of Biotie during the duration of the clinical development. *David Cook was appointed Chief Financial Officer (CFO) and a member of the Group's management team, effective 25 February 2013. *Biotie's financial result in Q1 2013 was a net income of EUR 10.0 million, mainly due to the one-time milestone payment by UCB which was recognized as revenue in the quarter. *Biotie ended the first quarter on 31 March 2013 with cash, cash equivalents and short term investments of EUR 44.7 million (EUR 33.8 million, 31 December 2012). Key Financials Figures in brackets, unless otherwise stated, refer to the same period in the previous year (EUR million) for the period January - March 2013 *Revenues EUR 15.3 million (0.0). Revenues consisted of the one-time milestone payment from UCB which was recognized as revenue in the first quarter. *Research and development costs EUR 3.1 million (5.8 ) *Financial result EUR 10.0 million (-7.5) *Cash flow from operating activities, continuing operations EUR 10.2 million (-9.3) *Earnings per share EUR 0.02 (-0.02 ) *Liquid assets at the end of period EUR 44.7 million (24.7) 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, "The first quarter was marked by two important developments for Biotie: the approval of Selincro in Europe, the first and only product labeled for reduction of alcohol intake, and a continued commitment from our partner UCB Pharma to advance our novel A2A receptor antagonist - tozadenant - for Parkinson's disease into Phase 3 trials. We are now focused on developing the Phase 3 program for tozadenant with UCB and on reviewing our pipeline as part of an ongoing portfolio review to ensure we are investing in products with the greatest opportunity to create value for Biotie and its shareholders going forward." Outlook for 2013 and key upcoming milestones Selincro (nalmefene): After the reporting period, on 22 April 2013 Biotie announced that its partner H.Lundbeck A/S has started launching Selincro on the first European markets, making the new treatment available to alcohol dependent patients in Norway, Finland, Poland and the Baltic countries. Lundbeck will continue the rollout of Selincro in Europe through 2013 and into 2014. According to the terms of the license agreement between Biotie and Lundbeck for Selincro, Biotie is eligible for milestone payments upon commercial launch of Selincro in France, Germany, Italy, Spain, and the United Kingdom, some of which may occur in 2013; royalties on sales in all launched markets, which are not expected to give rise to significant revenue in 2013; and a potential contribution to Lundbeck towards any required post approval commitments studies, which are not expected to be significant in 2013. Tozadenant (SYN115): Biotie has granted UCB Pharma S.A. a license for exclusive, worldwide rights to tozadenant. UCB and Biotie will collaborate on the on-going clinical development of tozadenant and UCB will be responsible for the manufacture and commercialization of tozadenant. Biotie will conduct phase 3 development in return for payments from UCB relating to defined development, regulatory and commercialization milestones. Patient enrollment in the phase 3 program is currently planned to commence by the first half of 2015. The additional payments from UCB for conducting phase 3 development of tozadenant, are not likely to have significant impact on profitability of Biotie over the duration of the clinical development. SYN120: 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 imminently. BTT-1023 (VAP-1 antibody): 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. Financial: While the company has recorded a net income for the quarter ended 31 March 2013, this was due to the timing of a one-off milestone payment in relation to tozadenant. Given that the size and timing of such milestone payments cannot be predicted, this quarter's performance should not be taken as indicative of future quarterly performance. Portfolio review: 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 now expects to report on the results of this review during Q3 2013, as it is taking longer than initially expected to complete. Conference call An analyst and media conference call will take place on Friday 3 May 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: +1646 254 3360 UK callers: +44(0)20 7136 2050 Finnish callers: +358(0)9 6937 9590 Access code: 1047561 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 22 April 2013 that its partner H.Lundbeck A/S (Lundbeck) has started launching Selincro(^TM) in the first European markets, making the new treatment available to alcohol dependent patients in Norway, Finland, Poland and the Baltic countries. The launch marks the first introduction of a new treatment for alcohol dependence in Europe for more than a decade. Lundbeck will continue the rollout of Selincro in Europe through 2013 and into 2014. According to the terms of the license agreement between Biotie and Lundbeck for Selincro, Biotie is eligible for milestone payments upon commercial launch of Selincro in France, Germany, Italy, Spain, and the United Kingdom, some of which may occur in 2013; royalties on sales in all launched markets, which are not expected to give rise to significant revenue in 2013; and a potential contribution to Lundbeck towards any required post approval commitments studies, which are not expected to be significant in 2013. 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 28 February 2013 received European marketing authorization 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 is transitioning into Phase 3 development for Parkinson's disease. Biotie shares are listed on NASDAQ OMX Helsinki Ltd. Turku, 3 May 2013 Biotie Therapies Corp. Board of Directors For further information, please contact: Virve Nurmi, Investor Relations Manager tel. +358 2 274 8900 e-mail: firstname.lastname@example.org Distribution: NASDAQ OMX Helsinki Ltd Main media www.biotie.com Attachment: Biotie_interim report Q1 2013 Biotie_interim report Q1 2013 ------------------------------------------------------------------------------ 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#1698727
Biotie Therapies Oyj : Biotie interim report 1 January - 31 March 2013
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