Biotie interim report 1 January - 30 September 2013;
Company Highlights July - September 2013
Completed a portfolio review which established the best way for Biotie to maximize value from its current products. Introduced a new "evolved" strategy to seek additional pipeline opportunities, including those that Biotie could potentially develop itself through to regulatory approval and beyond.
H. Lundbeck A/S (Lundbeck) launched Selincro in further European markets, including Italy which resulted in a milestone payment of EUR 2 million; Biotie received royalties on sales of Selincro across all markets of EUR 36,000 during the third quarter. To date Biotie has received EUR 16 million in milestone payments from Lundbeck.
Continued to actively develop NRL-1, a proprietary intranasal diazepam formulation and an important strategic opportunity for Biotie. NRL-1 became part of Biotie`s development portfolio in June 2013 through an option arrangement with Neurelis, Inc.
Continued to advance Phase 3 development plans for tozadenant (SYN115) and, in connection, received the first Phase 3 development milestone from its partner UCB Pharma S.A. (UCB). This amounted to USD 8.5 million, of which EUR 2.5 million was recognized as revenue during the quarter.
Biotie`s financial result for Q3 2013 was a net loss of EUR 1.8 million; the financial result for 9 months ended 30 September 2013 was a net income of EUR 4.1 million.
Biotie ended the third quarter on 30 September 2013 with cash, cash equivalents and short term investments of EUR 46.9 million (EUR 44.7 million, 30 June 2013).
Key Financials Figures in brackets, unless otherwise stated, refer to the same period in the previous year (EUR million)
for the period July - September 2013
Revenues EUR 4.5 million (3.9).
Research and development costs EUR 4.4 million (4.5)
Financial result EUR -1.8 million (-2.4)
Cash flow from operating activities EUR 2.7 million (-3.5)
Earnings per share EUR -0.00 (-0.01)
for the period January - September 2013
Revenues EUR 21.9 million (4.2).
Research and development costs EUR 10.7 million (17.0)
Financial result EUR 4.1 million (-16.8)
Cash flow from operating activities EUR 13.4 million (-19.4)
Earnings per share EUR 0.01 (-0.04)
Liquid assets at the end of period EUR 46.9 million (44.7)
The interim report is unaudited. Liquid assets comprise cash, cash equivalents and investments held to maturity.
Timo Veromaa, Biotie`s President and CEO commented, "The completion of our portfolio review was an important step in Biotie`s development as we continue to maximize the value our current pipeline. Our decision to evolve our strategy to acquire additional product opportunities, including those that Biotie could potentially develop itself through to regulatory approval and beyond, is designed to give us greater self-determination and to generate attractive returns for our shareholders."
Outlook for 2013 and key upcoming milestones:
Selincro: Lundbeck will continue the rollout of Selincro in additional European markets into 2014. Biotie is eligible for launch milestones in France, Germany and Spain, and royalties on sales in all markets.
Tozadenant (SYN115): Phase 3 development plans will continue in collaboration with UCB. Biotie is expected to receive additional payments from UCB in the low triple digit millions in total over the next six years, based on the successful completion of defined development, regulatory and commercialization milestones. The Phase 3 program in Parkinson`s disease is expected to commence by H1 2015.
NRL-1: Biotie expects to exercise the option to acquire Neurelis, Inc. in the first half of 2014 following completion of ongoing manufacturing and pre-clinical work and discussions with the FDA.
Nepicastat (SYN117): A Phase 2 trial in cocaine dependence, funded by NIDA, is recruiting and is expected to take two years to complete.
SYN120: Discussions for a potential partnership for SYN120 are at an advanced stage.
BTT-1023: The Company is in advanced discussions for non-dilutive co-funding for this product.
Strategic: The Company will use its strong financial position to seek additional pipeline opportunities, including those that it could potentially develop itself through to regulatory approval and beyond.
Financial: While the company has recorded a net income for the nine month period ended 30 September 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, the performance of any period should not be taken as indicative of future quarterly performance.
Conference call
An analyst and media conference call will take place on Friday 1 November 2013 at 2.30 p.m. UK time (4.30 p.m. Finland and 9.30 a.m. EST). 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 3367 UK callers: +44(0)20 3427 1903 Finnish callers: +358(0)9 6937 9543
Access code: 7827706
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 31 October 2013 that its partner H.Lundbeck A/S (Lundbeck) has expanded its existing alliance with Otsuka Pharmaceutical Co. Ltd. (Otsuka) to include development and commercialization of nalmefene (sold under the brand name Selincro in Europe) in Japan. Lundbeck and Otsuka will jointly finalize the clinical program for nalmefene in Japan, and it is expected that the first clinical phase III study will be initiated during 2014.The announcement will have no immediate financial impact on Biotie.
About Biotie
Biotie is a specialized drug development company focused primarily on products for neurodegenerative and psychiatric disorders. For the past years, Biotie has successfully operated a strategy built around search, profile and partner. This has delivered Selincro (nalmefene) for alcohol dependency, which received European marketing authorization in February 2013 and is currently being rolled out across Europe by partner H. Lundbeck A/S, and tozadenant, a novel A2a antagonist which is transitioning into Phase 3 development for Parkinson`s disease in collaboration with UCB Pharma S.A. Biotie also has exclusive rights through an option to acquire Neurelis Inc., which includes NRL-1, an intranasal formulation of diazepam for epileptic seizure management. Biotie plans to seek further opportunities of this kind to generate a strong portfolio of products. Biotie`s shares are listed on NASDAQ OMX Helsinki. 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
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