Biotie Therapies Corp. released its H1-2013 interim report

19-8-2013 — /EuropaWire/ — Company Highlights April – June 2013

• Biotie obtained an exclusive option to acquire Neurelis, Inc., a private specialty pharmaceutical company based in San Diego, CA, focused on developing products for epilepsy and other disorders of the central nervous system.
• Biotie’s partner H. Lundbeck A/S (Lundbeck) launched Selincro(R), a new treatment for alcohol dependent patients, in the first European markets. By the end of June, Selincro was available in more than 10 EEA countries. The quarter’s revenues include a milestone payment of EUR 2 million following the UK launch in May and  royalties of EUR 0.07 million in relation to sales made by Lundbeck during the quarter.
• Biotie announced the start of a Phase 2 clinical study evaluating nepicastat (SYN117) in cocaine dependence. The National Institute on Drug Abuse (NIDA) at the US National Institutes of Health is funding the conduct of the study.
• Biotie’s financial result in Q2 2013 was a net loss of EUR 4.0 million; the financial result for 6 months ended 30 June 2013 was a net income of EUR 6.0 million.
• Biotie ended the second quarter on 30 June 2013 with cash, cash equivalents and short term investments of EUR 44.7 million (EUR 44.7 million, 31 March 2013).

Key Financials
Figures in brackets, unless otherwise stated, refer to the same period in the previous year (EUR million)

for the period April – June 2013

• Revenues EUR 2.1 million (0.3).
• Research and development costs EUR 3.3 million (6.7 )
• Financial result EUR -4.0 million (-7.0)
• Cash flow from operating activities EUR 0.5 million (-6.7)
• Earnings per share EUR -0.01 (-0.02)

for the period January – June 2013

• Revenues EUR 17.4 million (0.4). Revenues consisted of the one-time milestone payment from UCB; and the UK launch milestone and royalties for Selincro from Lundbeck.
• Research and development costs EUR 6.3 million (12.5)
• Financial result EUR 6.0 million (-14.5)
• Cash flow from operating activities EUR 10.7 million (-15,9)
• Earnings per share EUR 0.01 (-0.04)

• Liquid assets at the end of period EUR 44.7 million (18.5)

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, “This has been an important quarter for Biotie as we witnessed the initial rollout of our first commercial product Selincro, for alcohol dependence, by our partner Lundbeck. We also purchased an option to acquire Neurelis Inc., a private CNS focused company, which brings with it NRL-1, a niche intranasal product for epileptic seizures that represents an exciting potential development opportunity for Biotie. We are currently in the process of further assessing NRL-1 and our proprietary programs as part of our ongoing portfolio review and we expect to provide an update on that during Q3 this year.”

Outlook for 2013 and key upcoming milestones

Selincro (nalmefene): Further to the launch of Selincro by Lundbeck in the first European markets in April 2013 and the subsequent launch in the UK in May 2013, for which Biotie received a milestone of EUR 2 million, Lundbeck will continue to launch Selincro in additional European markets through 2013 and into 2014. This is planned to include launches in Italy, Germany, Spain and France, for which Biotie would receive additional milestones of EUR 2 million in each market; some of these may occur in 2013. In addition, Biotie will continue to receive royalties on sales in all launched markets and make a contribution to Lundbeck towards any required post approval commitments studies, neither of which are expected to have a significant financial impact in 2013.

Tozadenant (SYN115): Biotie has granted UCB a license for exclusive, worldwide rights to tozadenant. Biotie and UCB 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, some of which may be received in 2013, are not likely to have a significant impact on the profitability of Biotie over the duration of the clinical development.

Neurelis (NRL-1): In June, 2013 Biotie obtained an exclusive option to acquire Neurelis, Inc., a private specialty pharmaceutical company, focused on developing products for epilepsy and other disorders of the central nervous system. Neurelis’ lead product, NRL-1, is a proprietary intranasal formulation of diazepam which is being developed to help patients with epilepsy who require intermittent use of diazepam to manage bouts of acute and repetitive seizures.

Under the terms of the option and merger agreement, Biotie has made a payment of US$1.0 million to Neurelis for the exclusive right, but not the obligation, to acquire all of the outstanding shares of Neurelis for a pre-defined amount of US$8.75 million, subject to certain adjustments, to be paid in new shares of Biotie to be issued on approval by the Board of Directors. Biotie may exercise the option right up until the start of the pivotal pharmacokinetic clinical studies that will form the basis of a 505 (b)(2) New Drug Application (but no later than December 3, 2014). This is expected in approximately 12-18 months’ time.

In the meantime, Biotie is responsible for the development of NRL-1, which primarily includes further manufacturing and pre-clinical work which Biotie is currently conducting.

SYN120: Biotie has generated an extensive clinical and preclinical data package for SYN120 and the compound is ready to enter Phase 2.  Biotie is currently seeking a partnership for late stage clinical trials and has received interest from several parties.

Nepicastat (SYN117): Biotie, in partnership with the U.S. National Institute of Drug Abuse (NIDA), is jointly investigating the safety and efficacy of nepicastat in the treatment of cocaine dependence. A Phase 2 trial started in May 2013 and is expected to take approximately two years to complete.

BTT-1023 (VAP-1 antibody): Biotie is currently seeking a partner to best maximize the value of BTT-1023.

Financial: While the company has recorded a net income for the six month period ended 30June 2013, this was primarily due to the timing of a one-off milestone payment in relation to tozadenant in the first quarter. Given that the size and timing of such milestone payments cannot be predicted, this period’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 expects to report on the results of this review during Q3 2013.

Conference call

An analyst and media conference call will take place on Friday 2 August 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: +1 646 254 3367
UK callers: +44 (0)20 3427 1913
Finnish callers: +358 (0)9 6937 9590

Access code: 5758079

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.

Biotie’s most advanced product, SelincroR (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, 2 August 2013

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_interim report Q2 2013