BIOTIE THERAPIES CORP. INTERIM REPORT 7 May 2010 - 9.00 a.m. Biotie Therapies interim report: January - March 2010 - Biotie reports positive data from clinical study with VAP-1 antibody in rheumatoid arthritis patients. - After the reporting period, Biotie announces intention to continue development of VAP-1 antibody after Roche notifies Biotie that it does not intend to exercise its option to license the program. - After the reporting period, Biotie announces positive data from clinical study with oral PDE4 inhibitor in healthy volunteers. ELB353 is well tolerated and shows clear pharmacological activity. - Research collaboration between Biotie and Pfizer regarding the identification of novel PDE10 inhibitors for schizophrenia will end in June 2010. Pfizer retains the commercial rights for all product candidates discovered until then. - Revenue in Q1 stood at EUR 1.2 million (EUR 1.4 million in Q1 2009). Net loss for Q1 stood at EUR 3.7 million (EUR 2.9 million in Q1 2009), basic earnings per share amounted to EUR -0.02 (EUR -0.02 for Q1 2009). - Cash flow from operations in Q1 amounted to EUR -4.4 million (EUR -3.3 million in Q1 2009). As of 31 March, liquid assets amounted to EUR 15.2 million (EUR 22.2 million as of 31 March, 2009). - Biotie's Annual General Meeting was held on 15 April, 2010, after the reporting period. - Ms. Merja Karhapää and Mr. James S. Shannon were newly elected to the Board of Directors; Mr. Peter Fellner has been appointed as the new chairman of the Board of Directors. Timo Veromaa, Biotie's President and CEO: "2010 will be a crucial year in Biotie's history. We expect our partner Lundbeck to announce top-line data of the ongoing phase III studies with our lead product nalmefene for the treatment of alcohol dependence. Also, with the positive data generated in our clinical programs VAP-1 antibody and ELB353, we are now at the turning point, at which we will start seeking partners in addition to Seikagaku with whom to continue the development of these programs." Outlook for 2010 - Biotie will continue supporting its licensing partner Lundbeck in the development of nalmefene for the treatment of alcohol addiction. Phase 3 clinical data for the ongoing studies is expected towards the end of 2010; a possible marketing authorization submission in the EU is anticipated in 2011. - Biotie will continue with the development of its proprietary VAP-1 antibody. Top-line data from an ongoing study in psoriasis patients is expected in mid 2010. While the rights to the product in Japan, Taiwan, Singapore, Australia and New Zealand have been granted to Seikagaku, Biotie retains the rights in the rest of the world and will be looking for additional partnering opportunities. - Biotie intends to continue active development of ELB 353 for the treatment of COPD. Further clinical trials are planned and discussions around possible collaboration opportunities will be started still in 2010. - Biotie will continue to work together with its partner Pfizer in a discovery alliance regarding the identification of PDE10 inhibitors for schizophrenia until June 2010. After that time, Pfizer retains the commercial rights for all product candidates discovered so far and Biotie is committed to support Pfizer in all development aspects. - Biotie is adequately funded to support its ongoing activities well into 2011, even in the absence of any additional income from new collaboration or licensing arrangements. Any possible commercial agreements with third parties relating to its clinical programs might significantly improve its financial position. A forecast on possible income from future licensing arrangements cannot be provided reliably. Financial calendar 2010 Publication of interim report January - June 2010: August 6, 2010 Publication of interim report January - September 2010: October 29, 2010 Conference call An analyst and media conference call will take place on May 7, 2010 at 2.00 p.m. Central European Time. The conference call will be held in English. The interim report will be presented by Biotie's President and CEO Timo Veromaa and CFO Thomas Taapken. Callers may access the conference directly at the following telephone numbers: UK: +44 (0)20 7136 2051, Finland: 0800 914 898, access code 6539994. Lines are to be reserved ten minutes before the start of conference call. In case you need additional information or assistance, please contact: Virve Nurmi, IR Manager Biotie Therapies, Tel.+358 2 2748 911 _______________________________________________________________________________ Biotie Therapies detailed interim report About Biotie Biotie is a drug discovery and development company focused on central nervous system and inflammatory diseases. It has a broad range of innovative small molecule and biological drug candidates at different stages of clinical and pre-clinical development. Biotie's products address diseases with high unmet medical need and significant market potential, including addiction and psychotic disorders, rheumatoid arthritis, psoriasis and chronic obstructive pulmonary disease (COPD). Drug development projects and operations: Nalmefene, a new treatment paradigm for alcohol dependence. Nalmefene builds on a novel principle of treating alcohol dependence. Unlike existing therapies, the treatment with Nalmefene is not aimed at keeping the patients from drinking. Nalmefene instead removes the desire to drink, thereby controlling and limiting the intake of alcohol. Nalmefene distinguishes itself by being available as an oral tablet formulation to be taken on an as needed basis. Biotie has granted worldwide rights (excluding Korea) for Nalmefene to Lundbeck. Currently, Lundbeck is undertaking three phase III clinical trials with Nalmefene for the treatment of alcohol dependence. We expect top-line data from the ongoing clinical trials to become available towards the end of 2010. Biotie is participating in financing some of the clinical development costs. ELB353, an oral PDE4 inhibitor for COPD in clinical development. ELB353 is a once-daily, oral phosphodiesterase 4 (PDE4) inhibitor with therapeutic potential in chronic inflammatory disorders, particularly in chronic obstructive pulmonary disease (COPD), a serious disorder with major unmet medical need. After the reporting period, Biotie reported that it has successfully completed a Phase I trial with its orally administered PDE4 inhibitor ELB353. The study evaluated the safety, tolerability, pharmacokinetic characteristics and pharmacodynamic effects of repeated oral doses of ELB353 in 48 healthy male volunteers. ELB353 was generally well tolerated, and no serious or severe adverse events were reported in any of the study subjects. The pharmacokinetic characteristics of ELB353 demonstrated its suitability for a once daily dosing regimen. Robust and statistically highly significant biomarker responses confirmed the pharmacological activity of well tolerated doses of ELB353 in man. Vascular Adhesion Protein-1 (VAP-1), a key inflammation receptor. VAP-1 has been shown to play a key role in inflammatory chronic diseases such as rheumatoid arthritis, psoriasis and diabetes. Potentially it also plays a role in other chronic inflammatory diseases for which there is a clear unmet medical need. Biotie has a vast knowledge and strong intellectual property position around this target. VAP-1 function can be blocked by either antibody (biologic) drugs or small molecule drugs which target the enzyme (SSAO) domain of the receptor. Both approaches are being pursued by Biotie for various therapeutic indications. VAP-1 antibody, a high value biologic for inflammatory diseases in clinical development. Biotie is developing a fully human monoclonal antibody which blocks VAP-1 function. In January 2010 Biotie reported that it has successfully completed a clinical trial with the product in rheumatoid arthritis patients, demonstrating the safety, tolerability, and pharmacokinetics of repeated doses of intravenously administered antibody in 24 rheumatoid arthritis patients. Although the study was not designed to enable formal statistical evaluation of therapeutic activity, in several assessments of treatment effect such as Disease Activity Score based on 28 joint assessment (DAS28) criteria, American College of Rheumatology (ACR) criteria, physician's global assessment and erythrocyte sedimentation rate, responses in higher dose groups were greater than in the placebo group. Several patients receiving higher doses of BTT-1023 reached an ACR50 response (i.e. a 50% reduction in their ACR score) during treatment whereas none of the placebo patients reached an ACR50 response. A similarly designed clinical study initiated in March 2009 in psoriasis patients is currently ongoing and results from this study are expected in the second quarter of 2010. Biotie has granted a license to Seikagaku Corporation to the rights for the product for Japan, Taiwan, Singapore, New Zealand, and Australia against up to USD 16.7 million in milestone payments plus royalties on sales in the territory. After the reporting period, Biotie announced that it regains all commercial rights to the VAP-1 antibody except in certain territories in which the product is licensed to Seikagaku. Roche informed Biotie that it does not intend to exercise its option to in-license the VAP-1 antibody product for its own strategic portfolio related reasons. Biotie will continue own development efforts and seek partners in addition to Seikagaku. VAP-1 SSAO inhibitors. Biotie is pursuing the development of small molecule inhibitors of VAP-1 SSAO. Currently the program is at pre-clinical stage. Biotie has granted options to the program to Roche and Seikagaku (for Japan, Taiwan, Singapore, Australia and New Zealand). Under the terms of the option agreements, the parties carry their own costs, but Biotie retains ownership of the developed compounds until Roche chooses to exercise its option for in-licensing. Phosphodiesterase 10 (PDE10) inhibitors, a novel treatment paradigm for schizophrenia. PDE10 is a novel molecular drug target in schizophrenia and Biotie has shown antipsychotic activity of PDE10 inhibitors in animal models. Biotie's PDE10 inhibitors are believed to serve the unmet medical need for novel anti-psychotic drugs with an improved side effect profile and improved efficacy in schizophrenia. Biotie and Pfizer are in a discovery alliance to jointly identify novel PDE10 inhibitors. This alliance will end in June 2010. After that, Pfizer retains the commercial rights for all product candidates discovered until then. So far, the program has advanced one compound into preclinical development. Financial review Revenues: Revenue for the reporting period amounted to EUR 1.2 million (EUR 1.4 million in Q1 2009) and consisted of income from the ongoing research collaboration with Pfizer as well as periodization of previously received up-front payments from the licensing agreements the company has in place with several licensing partners. In addition, Biotie received EUR 0.2 million (EUR 0.3 million in Q1 2009) non-dilutive funding under a grant from the central development agency for the state of Saxony (Sächsische Aufbaubank, SAB). Financial result: The net loss for the reporting period amounted to EUR 3.7 million (EUR 2.9 million in Q1 2009). Research and development costs for the reporting period amounted to EUR 3.8 million (EUR 3.9 million in Q1 2009). Financing: Cash and cash equivalents totaled EUR 15.2 million at the end of the reporting period (EUR 22.2 million). The company has invested its liquid assets into bank deposits. Bank deposits with maturity more than 3 months are reported in "investments held to maturity" whereas deposits with maturity less than 3 months are reported in the "cash and cash equivalents". Biotie has a standby distribution agreement with US fund Yorkville in place. Yorkville is obliged to subscribe and pay for ordinary no-par Biotie shares up to a total value of EUR 20 million during the period until September 2012 at Biotie's discretion (Biotie option). The purpose of this arrangement is to have an option to secure the financing of Biotie's working capital in the short and medium term. Shareholder's equity: The shareholders' equity of the group amounts to EUR -12.6 million (IFRS). Biotie's equity ratio was -46.2 % on 31 March 2010 (-6.9 % on 31 March 2009). Investments and cash flow: Cash flow from operations was EUR -4.4 million for January - March (EUR -3.3 million during Q1 2009). The group's investments during the reporting period amounted to EUR 0.1 million (EUR 0.0 million Q1 2009). AGM decisions and corporate governance The Annual General Meeting (AGM) of Biotie Therapies Corp. was held on15 April 2010 and resolved on the following items: - Adoption of financial statements 2009 - Transfer of annual loss to unrestricted equity and no dividend paid - Discharge from liability for the members of the Board of Directors and Managing Director - Reduction of members of the Board of Directors to 7 (seven) - Election of Ms. Merja Karhapää and Mr. James S. Shannon as new members to the Board of Directors; re-election of Messrs. Peter Fellner, Bernd Kastler, Pauli Marttila, Riku Rautsola, Piet Serrure. - Resolution to adopt compensation to members of the Board to EUR 3000 per month and EUR 4000 per month to the chairman of the Board - Renewed appointment of PricewaterhouseCoopers Oy and Mr. Janne Rajalahti as auditors - Authorization to the Board of Directors to issue up to 80 million shares in one or more issues pursuant to chapter 10 of the Companies Act (effective until 30 June 2011 and superseding all earlier authorizations) Organization of the Board of Directors The Board of Directors elected Peter Fellner as new Chairman of the Board. Paul Marttila was elected as Deputy Chairman. Mr. Mikko Heinonen from the law firm Hannes Snellmann continues as secretary of the Board of Directors. The Board of Directors decided that the Audit Committee and the Nomination and Remuneration Committee continue to assist the Board in its work. The Board of Directors elected among its members Merja Karhapää, Bernd Kastler (chairman), Riku Rautsola and Piet Serrure as members of the Audit Committee. Peter Fellner (chairman), Pauli Marttila and James S. Shannon were elected to the Nomination and Remuneration Committee. Share capital and shares Biotie shares are all of the same class and have equal rights. Each share entitles the holder to one vote at the general meeting of shareholders. All shares are freely transferable and are quoted on NASDAQ OMX Helsinki Ltd (Small cap, Healthcare). Biotie´s share capital is EUR 51,506,678.10 (FAS), the total number of shares is 158,752,560. Of these shares, 463,255 are owned by Biotie Therapies Corp. Changes in ownership During the reporting period, the company became aware of one notice of change in ownership exceeding the disclosure threshold. Information on notices of change in ownership and a monthly updated list of Biotie's major shareholders is available on the company's website at www.biotie.com/investors <http://www.biotie.com/investors>. Short-term risks and uncertainties Biotie's strategic risks are predominantly related to the technical success of the drug development programs, regulatory issues, strategic decisions of its commercial partners, ability to obtain and maintain intellectual property rights for its products, launch of competitive products and the development of the sales of its products. The development and success of Biotie's products depends to a large extent on third parties. Any adverse circumstance in relation to any of its R&D programs might impair the value of the asset and thus, represent a severe risk to the company. Such adverse events could happen on a short term notice and are not possible to foresee. The key operational risks of Biotie's activities include the dependency on key personnel, assets (especially in relation to intellectual property rights) and dependency on its license partners' decisions. Furthermore, significant financial resources are required to advance the drug development programs into commercialized pharmaceutical products. To fund the operations, Biotie relies on financing from three major sources: income from its license partners, grant income and raising equity financing in the capital markets. Although Biotie has currently active license agreements in place, the termination of any such agreement would have a negative effect on the short to medium term access to liquidity for the company. Grants have been historically available to Biotie at substantial levels. Availability of grants in the future cannot be guaranteed and this thus poses a potential risk to the income situation of the group in the future. Currently ongoing grant programs are available until Q3 2010. The company relies on capital markets to raise equity financing from time to time. There can be no assurance that sufficient funds can be secured in order to permit the company to carry out its planned activities. Current capital market conditions are volatile and it is currently uncertain whether the company can secure equity financing if and when it needs it, even though it was successful at doing so in December 2009. To protect the continuity of Biotie's operations, sufficient liquidity and capital has to be maintained in the company and its subsidiaries. The group aims to have cash funds to finance at least one year's operations at all times. The group can influence the amount of capital by adapting its cost basis according to the financing available. Management monitors the capital and liquidity on the basis of the amount of equity and cash funds. These are reported to the Board on a monthly basis. IFRS and accounting principles This interim financial report has been prepared in accordance with IFRS recognition and measurement principles, and applying the same accounting policy as for the 2009 financial statements. The interim report has not been prepared in accordance with IAS 34, Interim Financial Reporting. This interim report is unaudited. Turku, May 7, 2010 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 <mailto:virve.nurmi@biotie.com> Distribution: NASDAQ OMX Helsinki Ltd Main media www.biotie.com <http://www.biotie.com/> CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME (IFRS) 1.1.- 1.1.- 1.1.- 31.3.2010 31.3.2009 31.12.2009 EUR 1,000 3 months 3 months 12 months -------------------------------------------------------------------------- Revenue 1,201 1,383 5,628 Research and -3,769 -3,925 -21,109 development expenses General and -1,045 -962 -3,768 administrative expenses Other operating income 95 404 1,618 -------------------------------------------------------------------------- Operating profit/loss -3,518 -3,100 -17,631 Financial income 45 259 627 Financial expenses -213 -277 -938 -------------------------------------------------------------------------- Profit/loss before taxes -3,687 -3,118 -17,942 Taxes 0 235 1,859 -------------------------------------------------------------------------- Net income/loss -3,687 -2,883 -16,083 Total comprehensive income of the period -3,687 -2,883 -16,083 Net income/loss attributable to Parent company shareholders -3,687 -2,883 -16,083 Total comprehensive income attributable to: Parent company shareholders -3,687 -2,883 -16,083 Earnings per share (EPS) -0.02 -0.02 -0.11 basic & diluted, EUR CONSOLIDATED STATEMENT OF FINANCIAL POSITION (IFRS) EUR 1,000 31.3.2010 31.3.2009 31.12.2009 ----------------------------------------------------------------------------- Assets Non-current assets Intangible assets 7,204 12,704 7,186 Goodwill 379 379 379 Property, plant and equipment 2,588 2,652 2,666 Other shares 10 0 10 ----------------------------------------------------------------------------- 10,181 15,735 10,241 Current assets Prepaid expenses 152 0 0 Available for sale investment 34 131 34 Investments held to maturity 0 14,900 0 Accounts receivables and other receivables 1,609 2,198 1,507 Financial assets at fair value through 8,881 0 8,853 profit or loss Cash and cash equivalents 6,351 7,327 10,891 ----------------------------------------------------------------------------- 17,028 24,556 21,285 Total 27,209 40,291 31,526 Equity and liabilities Shareholders' equity Share capital 43,057 36,361 43,057 Reserve for invested unrestricted equity 1,180 980 1,180 Retained earnings -53,130 -37,231 -37,092 Net income/loss -3,687 -2,883 -16,083 ----------------------------------------------------------------------------- Shareholders' equity total -12,580 -2,773 -8,938 Non-current liabilities Provisions 150 119 160 Non-current financial liabilities 25,552 25,262 25,597 Pension benefit obligation 549 579 543 Other non-current liabilities 6,913 6,130 6,729 Non-current deferred revenues 902 2,248 1,375 Deferred tax liabilities 0 1,624 0 ----------------------------------------------------------------------------- 34,066 35,963 34,404 Current liabilities Provisions 597 624 594 Pension benefit obligation 16 14 17 Current financial liabilities 219 145 217 Current deferred revenues 1,891 3,309 1,953 Accounts payable and other current liabilities 3,000 3,008 3,279 ----------------------------------------------------------------------------- 5,723 7,100 6,060 Liabilities total 39,789 43,063 40,464 Total 27,209 40,291 31,526 CONSOLIDATED STATEMENT OF CHANGES IN SHAREHOLDERS' EQUITY Attributable to equity holders of the parent company EUR 1,000 Shares Share Reserve Own Retained Share- (1000 Capital For Shares Earnings holders' pcs) invested equity Un- total restricted equity -------------------------------------------------------------------------------- BALANCE AT 1.1.2009 144,321 36,361 980 -15 -37,215 110 -------------------------------------------------------------------------------- Total comprehensive income -16,083 -16,083 for the period Options granted 339 339 Share issue 14,432 7,216 7,216 Cost of share issue -520 -520 Reissue of own shares 200 -200 0 pursuant to SEDA agreement -------------------------------------------------------------------------------- 14,432 6,696 200 0 -15,944 -9,048 -------------------------------------------------------------------------------- BALANCE AT 31.12.2009 158,753 43,057 1,180 -15 -53,160 -8,938 -------------------------------------------------------------------------------- Total comprehensive income -3,687 -3,687 for the period Options granted 45 45 -------------------------------------------------------------------------------- 0 0 0 0 -3,642 -3,642 -------------------------------------------------------------------------------- BALANCE AT 31.3.2010 158,753 43,057 1,180 -15 -56,802 -12,580 -------------------------------------------------------------------------------- CONSOLIDATED STATEMENT OF CASH FLOWS 1.1.- 1.1.- 1.1.- 31.3.2010 31.3.2009 31.12.2009 EUR 1,000 3 months 3 months 12 months -------------------------------------------------------------------------------- Cash flow from operating Activities Net income/loss -3,687 -2,883 -16,083 Adjustments: Non-cash transactions -297 -721 3,331 Addition/disposal due to revaluation of -28 0 -53 financial assets at fair value through profit or loss Interest and other financial expenses 213 277 963 Interest income -17 -259 -599 Taxes 0 -235 -1,859 Change in working capital: Change in accounts receivables and other -196 -464 -126 receivables Change in accounts payable and other -305 940 1,172 liabilities Change in mandatory provisions -7 -19 -8 Interests paid -46 -59 -106 Interests received 3 96 48 Taxes paid -49 -14 -6 -------------------------------------------------------------------------------- Net cash from operating activities -4,416 -3,341 -13,326 Cash flow from investing activities Change in financial assets at fair value through profit or loss Additions 0 0 -9,000 Disposals 0 0 200 Change in investments held to maturity Additions 0 -900 -900 Disposals 0 4,500 20,142 Investments to tangible assets -80 -3 -165 -------------------------------------------------------------------------------- Net cash used in investing activities -80 3,597 10,277 Cash flow from financing activities Payments from share issue 0 0 7,216 Share issue costs 0 0 -520 Proceeds from borrowings 0 360 632 Repayment of loans 0 0 -40 Repayment of lease Commitments -43 -26 -86 -------------------------------------------------------------------------------- Net cash from financing activities -43 333 7,202 Net increase (+) or decrease (-) -4,450 589 4,153 in cash and cash equivalents Cash and cash equivalents in the 10,891 6,738 6,738 beginning of the period Cash and cash equivalents in the 6,351 7,327 10,891 end of the period Contingent liabilities EUR 1,000 31.3.2010 31.3.2009 31.12.2009 ---------------------------------------------------------- Operating lease commitments 125 166 137 Due within a year 84 80 88 Due later 41 85 49 Rent commitments 343 493 382 Due within a year 237 233 237 Due later 106 260 145 ---------------------------------------------------------- Total 468 659 519 The Group leases motor vehicles, machines and equipment with leases of 3 to 5 years. Rent commitments include Pharmacity premises until 30 November 2011. These premises have been subleased. Commitments On March 31, 2010 Biotie had purchase commitments, primarily for contract research work services, totaling EUR 5.3 million. KEY FIGURES 1.1.- 1.1.- 1.1.-31.12.2009 31.3.2010 31.3.2009 EUR 1,000 3 months 3 months 12 months -------------------------------------------------------------------------- Business development Revenues 1,201 1,383 5,628 Personnel on average 82 80 81 Personnel at the end of period 83 80 82 Research and development costs 3,769 3,925 21,109 Capital expenditure 80 3 475 Profitability Operating profit/loss -3,519 -3,100 -17,631 as percentage of revenues, % -292.9 -224.2 -313.27 Profit/loss before taxes -3,687 -3,118 -17,942 as percentage of revenues, % -307.0 -225.5 -318.80 Balance sheet Cash and cash equivalents 15,232 22,227 19,744 Shareholders equity -12,580 -2,773 -8,938 Balance sheet total 27,209 40,291 31,526 Financial ratios Return on equity, % - - - Return on capital employed, % -25,9 -12.9 -86.0 Equity ratio, % -46,2 -6.9 -28.4 Gearing, % -83.8 -114.7 -67.9 Per share data Earnings per share (EPS) basic & -0.02 -0.02 -0.11 diluted, EUR Shareholders´equity per share, EUR -0.02 -0.02 -0.0563 Dividend per share, EUR - - - Pay-out ratio, % - - - Effective dividend yield, % - - - P/E-ratio - - - Share price Lowest share price, EUR 0.53 0.23 0.23 Highest share price, EUR 0.65 0.48 0.67 Average share price, EUR 0.57 0.28 0.42 End of period share price, EUR 0.55 0.37 0.55 Market capitalization 87.3 53.4 87.3 at the end of period MEUR Trading of shares Number of shares traded 24,649,500 14,080,963 51,471,584 As percentage of all 15.5 9.8 32.4 Adjusted weighted average 158,752,560 144,320,560 144,992,735 number of shares during the period Adjusted number of shares 158,752,560 144,320,560 158,752,560 at the end of the period Formulas for the Calculation of the Key figures Return on capital employed, % Profit (loss) before taxes + interest expenses and other financial expenses --------------------------------------------------------------- x 100 Balance sheet total - non-interest bearing liabilities Equity ratio, % Shareholders' equity --------------------------------------------------------------- x 100 Balance sheet total - advanced received Gearing, % Interest bearing liabilities - cash and cash equivalents -------------------------------------------------------------- x 100 Shareholders' equity Earnings per share (EPS) Profit attributable to parent company shareholders ------------------------------------------------------------------ Adjusted average number of outstanding shares during the period Shareholders' equity per share Shareholders' equity ------------------------------------------------------------------ Adjusted number of shares at the end of the period [HUG#1412886]