BIOTIE THERAPIES CORP. Stock Exchange Release 3 August, 2012 at 9.00 a.m.
Biotie Interim report 1 January - 30 June 2012
Biotie agreed with its partner Seikagaku Corporation to terminate its license agreement for development and commercialization of Biotie's VAP-1 antibody program, BTT-1023, in Japan, Taiwan, Singapore, New Zealand and Australia. The license agreement also included an option for Biotie's VAP-1 SSAO small molecule inhibitors.
Biotie retained global development and commercialization rights to SYN120, a novel 5-HT6 receptor antagonist for cognitive disorders, following Roche's decision not to exercise its opt-in right.
Dr James S. Shannon resigned from the Board of Directors of Biotie to assume his newly appointed position as Chief Medical Officer at GlaxoSmithKline.
Figures in brackets, unless otherwise stated, refer to the same period in the previous year (EUR million)
for the period April - June 2012
Revenues EUR 0.3 million (0.5)
Research and development costs EUR 6.7 million (4.4)
Financial result (Net loss) EUR -7.0 million (-4.6)
Cash flow from operating activities, continuing operations EUR -6.7 million (-6.3)
Earnings per share EUR -0.02 (-0.01)
for the period January-June 2012
Revenues EUR 0.4 million (0.9)
Research and development costs EUR 12.5 million (9.3)
Financial result (Net loss) EUR -14.5 million (-12.3)
Cash flow from operating activities, continuing operations EUR -15.9 million (-10.5)
Earnings per share EUR -0.04 (-0.04)
Liquid assets at the end of period EUR 18.5 million (40.9)
Liquid assets as at the end of Q2 2012 are expected to fund the current operations of the company into 2013. However, Biotie will need to secure its working capital beyond 2012 in order to execute its intended product development activities or reduce its cost base. Income generated from commercial agreements relating to Biotie's clinical programs may significantly improve the company's financial position, but no reliable forecast on any potential income from such commercial agreements can be provided at this stage. Biotie may therefore need to secure additional financing through the issue of shares, debt financing or exercising its existing standby equity distribution agreement (SEDA).
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 entering important times for the company as we await the decision on EU approval for Selincro, partnered with Lundbeck, and as we near data from our phase 2b trial in Parkinson's disease with tozadenant, now expected around year end. Significant investments during H2 2012 in the rest of the pipeline will be held back until we reach these two inflection points. We continue to pursue partnerships and have received significant interest in SYN120, our 5-HT6 antagonist, and believe we can find an attractive partner for this compound."
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 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-HT6 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 now 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.
An analyst and media conference call will take place on 3 August 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: +1 212 444 0895
UK callers: +44(0)20 7136 2056
Finnish callers: +358(0)9 2310 1621
Access code: 9495099
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 5 July, that enrollment is complete in its Phase 2b trial evaluating the safety and efficacy of tozadenant in Parkinson's disease. Biotie now expects the top-line data from this study to be available at around the year end of 2012, previous guidance was H1 2013.
On 2 August the Board of Directors appointed Ismail Kola as a member of the Nomination and Remuneration Committee. The composition of the Nomination and Remuneration Committee after the nomination is Peter Fellner as Chairman and William M. Burns and Ismail Kola as members.
Biotie announced on 3 August, that it has 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.
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, 3 August 2012
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
Biotie_Q2 2012 Interim report