4.3. 2014 BioTurku®

Biotie Financial Statement Release 2013

This is a summary of the financial statement report 2013 published 28 February 2014. 

Biotie Company Highlights October - December 2013

  • H. Lundbeck A/S (Lundbeck) continued the launch of Selincro (nalmefene) in further European markets, with launches in 17 countries by the end of 2013. Lundbeck expanded its existing alliance with Otsuka Pharmaceutical Co. Ltd. (Otsuka) to include development and commercialization of nalmefene in Japan. Biotie received royalties on sales of Selincro across all markets of EUR 49,000 during the fourth quarter.  
  • Continued activities to advance tozadenant (SYN115) into Phase 3 development in Parkinson's disease in collaboration with partner UCB Pharma S.A. (UCB). 
  • Continued to actively develop NRL-1, a proprietary intranasal diazepam that became part of Biotie's development portfolio in June 2013 through an option agreement with Neurelis, Inc. (Neurelis). 
  • Biotie's loan obligations to Tekes (The Finnish Funding Agency for Technology and Innovation) were reduced by EUR 2.8 million, with Tekes forgiving certain capital loans relating to Biotie's carbohydrate and cancer glycosylation projects that were discontinued in 2005 and an R&D loan relating to Biotie's Integrin project that was discontinued in 2010. 
  • Biotie has continued discussions for a partnership for further development and commercialization of SYN120. However, the Company has now concluded that Biotie will be better served by progressing SYN120 internally to the next stage of development. 
  • Biotie's financial result for Q4 2013 was a net income of EUR 2.1 million; the financial result for 12 months ended 31 December 2013 was a net income of EUR 6.3 million.  
  • Biotie ended 2013 with cash, cash equivalents and short term investments of EUR 43.7 million (EUR 46.9 million, 30 September 2013). Operating cash flow was EUR 10.9 million positive in 2013. 

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

Company Highlights for the period October - December 2013

  • Revenues EUR 5.8 million (0.6). 
  • Research and development costs EUR 6.7 million (7.2*) 
  • Financial result, continuing operations EUR 2.1 million (-8.8*) 
  • Cash flow from operating activities EUR -2.5 million (-7.7) 
  • Earnings per share EUR 0.00 (-0.02) 

for the period January - December 2013

  • Revenues EUR 27.7 million (4.8). 
  • Research and development costs EUR 17.4 million (24.2*) 
  • Financial result, continuing operations EUR 6.3 million (-25.6*) 
  • Cash flow from operating activities EUR 10.9 million (-27.1) 
  • Earnings per share EUR 0.01 (-0.06) 
  • Liquid assets at the end of period EUR 43.7 million (33.8).  

*Financial result for 2012 was impacted by a non-cash impairment charge of EUR 3.4 million for ronomilast

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, "2013 was a highly successful year for Biotie. Selincro was approved in Europe to treat alcohol dependence, and our partner, Lundbeck, is now launching the product across Europe. We secured a license agreement for our novel A2a antagonist, tozadenant, with UCB Pharma and received a $20 million milestone payment in 2013. With UCB funding we are now preparing to conduct Phase 3 tozadenant trials, which we expect to start in the first half of 2015. Also, a Phase 2 trial commenced for nepicastat in treatment seeking cocaine addicted patients, which is being funded by the U.S. National Institute on Drug Abuse (NIDA). We remain focused on delivering greater returns for our shareholders and as part of our evolving strategy we plan to use our financial strength to create a clinical platform with products that we can develop and commercialize ourselves."

Outlook for 2014 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 of EUR 2 million in each market, and further royalties on sales in all markets. Due to the early phase of the launch of Selincro no guidance can be given on expected royalty revenue in 2014. The first clinical phase 3 study under the joint Lundbeck/Otsuka development program in Japan is expected to be initiated in 2014, but this will not impact Biotie's financial results.

Tozadenant (SYN115): Phase 3 development plans will continue in collaboration with UCB and a key event this year will be the end-of-Phase 2 meeting with FDA, planned for H1 2014. 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, which are intended to be used to cover the costs of the development program. The Phase 3 program in Parkinson's disease is expected to commence by H1 2015.

NRL-1:  Biotie has concluded that its timely access to market is not guaranteed and that Biotie will not exercise the option to acquire Neurelis in H1 2014 as initially expected. Biotie will not make any further significant investment into this opportunity until further notice.

Nepicastat (SYN117): A Phase 2 trial in cocaine dependence, funded by NIDA, is continuing to recruit, and top-line data from the study is currently expected in H1 2015.

BTT-1023: Preparations for a clinical Phase 2 study in primary sclerosing cholangitis are ongoing. The Company is in advanced discussions for non-dilutive co-funding for the study.

SYN120: Preparations for a Phase 2 study in Alzheimer's disease have started, with the study expected to begin recruitment by the end of 2014.

Strategic: The Company will use its financial strength to seek additional pipeline opportunities, including those that it could potentially develop itself through to regulatory approval and beyond.

Financial: The company expects that both its revenue and research and development expenses will increase during 2014, as a result of milestones that will be received on both tozadenant and Selincro, and the development work that will be performed on tozadenant and SYN120.