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Biotie Therapies Corp Financial Statements 2015

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Biotie Therapies Corp Financial Statements 2015 1 Biotie Therapies Corp Financial statements 2015 2 Contents REPORT OF THE BOARD OF DIRECTORS .................................................................................................... 3 Key figures of consolidated financial statements..................................................................................20 Shares and shareholders ....................................................................................................................22 CONSOLIDATED FINANCIAL STATEMENTS (IFRS) ......................................................................................25 Consolidated statements of comprehensive income ............................................................................25 Consolidated statements of financial position......................................................................................26 Consolidated statements of changes in shareholders’ equity ................................................................27 Consolidated statements of cash flows................................................................................................28 Notes to the consolidated financial statements ...................................................................................29 PARENT COMPANY FINANCIAL STATEMENTS (FAS) ..................................................................................66 Parent company income statements ...................................................................................................66 Parent company balance sheets..........................................................................................................67 Parent company cash flow statement .................................................................................................68 Notes to the parent company financial statements ..............................................................................69 SIGNATURES OF THE REPORT FROM THE BOARD OF DIRECTORS AND FINANCIAL STATEMENTS .................77 AUDITOR’S REPORT ............................................................................................................................78 CONTACT INFORMATION .......................................................................................................................79 3 REPORT OF THE BOARD OF DIRECTORS Key events for the year 2015 • Tozadenant, Biotie’s lead pipeline program, is in Phase 3 development in Parkinson’s disease. Patient recruitment began in mid-2015 into the TOZ-PD study, a 450-patient double-blind, placebo-controlled Phase 3 study with an open-label extension that is being conducted under a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA). Top-line efficacy data is expected by the end of 2017. • The Phase 2 study for SYN120 in Parkinson's disease dementia, funded by a grant from the Michael J Fox Foundation (MJFF), continued to recruit patients, with top-line data expected by the end of 2016. • Patient enrollment commenced in March 2015 into a Phase 2 clinical study investigating Biotie's monoclonal anti-VAP-1 antibody BTT1023 in primary sclerosing cholangitis (PSC), with sufficient patients expected for the interim analysis by the end of 2016. The European Commission has also granted BTT1023 Orphan Drug Designation in the EU for the treatment of PSC. • Biotie raised €83.3 million gross proceeds from the issue of convertible notes (gross proceeds of €33.1 million) in May 2015 and from the issue of shares represented by American Depositary Shares (ADS) through a US public offering (gross proceeds of €50.2 million) in June 2015; the ADS were listed on Nasdaq Stock Market LLC under the ticker BITI. The proceeds will be used in the funding of the tozadenant Phase 3 clinical study. The convertible notes automatically converted into shares on completion of the US public offering and a total of 524,883,761 new shares in the Company were issued in the financing transaction pursuant to authorization by the shareholders at the May 2015 Annual General Meeting. In connection with the convertible notes, Biotie also issued warrants for 220,400,011 shares, which may be exercised at €0.17 per warrant until November 2020. Key event after the reporting period • On January 19, 2016 Biotie announced that Acorda Therapeutics, Inc. (Acorda) and Biotie Therapies Corp. have entered into a combination agreement whereby Acorda, either directly or through a wholly-owned subsidiary, will make a public tender offer in Finland and in the United States to purchase all of the issued and outstanding shares, American Depositary Shares (ADSs), stock options, share units and warrants in Biotie that are not owned by Biotie or any of its subsidiaries (the Tender Offer). The Board of Directors of Biotie unanimously recommends that the holders of Biotie shares, ADSs, option rights, share units and warrants accept the Tender Offer. The tender offer from Acorda values the Company at approximately €334 million, or approximately $363 million based on the exchange rate on January 18 the day before the tender offer was announced, which represents a premium to the closing price of approximately 95% for the Biotie shares on Nasdaq Helsinki Ltd and approximately 94% of the Biotie ADSs on the Nasdaq Stock Market LLC on January 18, 2016, the last trading day preceding the announcement. • Following the necessary regulatory approvals the acceptance period under the Tender Offer commenced on March 11, 2016 and will preliminarily expire on April 8, 2016. Key Financials for the period January - December 2015 Figures in brack ets, unless otherwise stated, refer to the same period in the previous year (EUR million) • Revenues EUR 3.7 million (14.9) • Research and development costs EUR 25.9 million (17.2) • Financial result, loss of EUR 28.3 million (loss of 35.2*) • Cash outflow from operating activities EUR 30.3 million (14.1) • Earnings per share EUR -0.04 (-0.08) 4 • Liquid assets at the end of period EUR 79.0 million (32.4) *Financial result for the twelve months ended 31 December 2014 was impacted by a non-cash impairment charge of EUR 27.6 million for nepicastat and SYN120. EUR thousand 1-12/ 1-12/ Continuing operations 2015 2014 12 months 12 months Revenues 3,736 14,901 Research and development costs (25,864) (17,192) Net income (loss) (28,323) (35,165)* Earnings (loss) per share (EUR) (0.04) (0.08) Cash outflow from operating 30,260 14,092 activities EUR thousand 31 Dec, 31 Dec, 2015 2014 Liquid assets 79,044 32,393 Equity 105,720 52,623 Equity ratio (%) 74.6 61.0 Product Portfolio Review: Selincro® (nalmefene) is a dual-acting opioid system modulator and the first therapy approved in Europe for the reduction of alcohol consumption in alcohol dependent individuals. Biotie has licensed global rights to Selincro to Lundbeck. Under the terms of the agreement with Lundbeck, Biotie is eligible for up to €94 million in upfront and milestone payments, of which €22.5 million had been received at December 31, 2015, plus royalties on sales of Selincro. Biotie is eligible to receive further potential milestone payments on launches in certain ex-EU markets and if the product reaches certain pre- determined sales. Biotie will continue to receive royalties on sales and will make a contribution to Lundbeck towards post approval commitment studies. Lundbeck received European marketing authorization for Selincro in February 2013 and the product has since been introduced in Europe. Favorable reimbursement decisions were made in the second half of 2014 in a number of key markets, including France, Spain and the United Kingdom. Lundbeck and Otsuka Pharmaceutical Co. Ltd. are collaborating, as part of their existing alliance, to develop and commercialize nalmefene in Japan, and a 660-patient Phase 3 study in Japan was commenced in Q1 2015. Tozadenant (SYN115) is an orally administered, potent and selective adenosine A2a receptor antagonist being developed for the treatment of Parkinson’s disease. In a 420-patient Phase 2b trial, tozadenant displayed clinically important and statistically significant effects across pre-specified primary and multiple secondary endpoints at a number of doses. In addition, tozadenant has been found to be generally safe and well tolerated in the ten clinical trials that have been conducted to date. Full data from the Phase 2b study were published in Lancet Neurology in July 2014. In July 2015, Biotie announced the start of the tozadenant Phase 3 study in Parkinson's disease (study TOZ- PD). The Company has agreed on a Special Protocol Assessment for TOZ-PD with the FDA. Based on 5 discussions with the FDA at the End of Phase 2 meeting, Biotie believes that the planned Phase 3 clinical program, together with existing data, could form the basis for approval of tozadenant as an adjunctive treatment to levodopa in Parkinson’s patients experiencing end-of-dose wearing off episodes. The TOZ-PD study will use the primary and secondary endpoints and enrollment criteria used in the Phase 2b clinical trial. The study is expected to enroll 450 patients experiencing levodopa related end-of-dose wearing off, who will be randomized to receive twice daily doses of 60mg or 120mg of tozadenant or placebo in addition to their standard anti-Parkinson’s disease medications for 24 weeks. The primary endpoint will be the reduction in the number of hours spent in the “off” state in patients taking tozadenant as compared to placebo between baseline and week 24, as assessed by patient-completed diaries and averaged over three consecutive
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