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2009-10-23 07:30:00 CEST 2009-10-23 07:32:31 CEST REGULATED INFORMATION Biotie Therapies - Interim report (Q1 and Q3)Biotie Therapies Corp. interim report January 1 - September 30, 2009BIOTIE THERAPIES CORP. INTERIM REPORT October 23, 2009 at 8.30 a.m. Biotie Therapies Corp. interim report January 1 - September 30, 2009 January - September 2009 in brief - In February and March, Biotie initiated two clinical studies in rheumatoid arthritis and psoriasis patients with its fully human VAP-1 monoclonal antibody. Results from these studies are expected to become available during the first half of 2010. - Biotie's Annual General Meeting was held on 29 May 2009. - Revenue for January - September amounted to EUR 4.5 million (EUR 4.0 million in 2008). Cash flow from operating activities in January - September was EUR -8.8 million (EUR -7.9 million for the same period in 2008). - The net loss for January - September stood at EUR 8.3 million (net loss for comparable period in 2008 was EUR 3.8 million) excluding extraordinary items in relation to write-offs of certain intangible assets. Total net loss for January - September including extraordinary items in relation to write-offs of intangible assets was EUR 12.1 million (net loss for January - September 2008 was EUR 3.8 million) and earnings per share for the period was EUR -0.08(EUR -0.04 in 2008). - As of September 30, the company's liquid assets amounted to EUR 16.7 million (EUR 21.0 million as of September 30, 2008). Q3/2009 in brief: - In August, the Board of Directors decided to pool capacities and strengthen the Company's focus on the more advanced key research and development programs and to terminate the development of certain early R&D programs as a result of the completion of the integration process with the German subsidiary Biotie Therapies GmbH. - In August, Biotie reached a milestone in its collaboration with Wyeth for the development of PDE10 (phosphodiesterase 10) inhibitors for schizophrenia, triggering a USD 1.0 million milestone payment to Biotie. - In September, Biotie started a clinical study with its phosphodiesterase 4 (PDE4) inhibitor ELB353, with the goal to evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of repeated doses of oral ELB353 in up to 48 healthy volunteers. Results are expected in the first half of 2010. - On September 28, the Board of Directors resolved to call an Extraordinary General Meeting of shareholders to be held on October 29, 2009. Among others, it proposes to elect Dr. Peter Fellner as new member of the Board of Directors. Furthermore, it proposes to authorize the Board of Directors to resolve on one or more issues which contains the right to issue new shares or dispose of the shares in the possession of the company and to issue options or other specific rights to the shares pursuant to chapter 10 of the Companies Act. The authorisation would consist of up to 72,000,000 shares in the aggregate and would supersede earlier authorizations. The authorisation is proposed to be used for material arrangements from the company's point of view, such as financing or implementing business arrangements or investments or for other such purposes determined by the Board of Directors in which case a weighty financial reason for issuing shares, options or other specific rights and possibly directing a share issue would exist. The authorisation could not, however, be used to create new share-based incentive schemes. - In September Biotie and Nordea Bank Finland Plc concluded a market making agreement. This agreement aims at increasing the share's liquidity and decreasing the share price volatility thus facilitating trading. - Revenue for July - September stood at EUR 1.8 million (EUR 0.8 million in 2008) and earnings per share was EUR -0.02 (EUR -0.01 in 2008). - The net loss for July - September stood at EUR 2.5 million (net loss of comparable period in 2008 was EUR 0.5 million). Cash flow from operating activities in July - September was EUR -2.1 million (EUR -2.1 million for comparable period in 2008). Events after the reporting period - In order to secure the financing of Biotie's working capital in the short and medium term, the Company has entered into a Standby Equity Distribution Agreement with YA Global Master SPV Ltd. ("YA Global") a fund managed by Yorkville Advisors, LLC of Jersey City, New Jersey, USA ("Yorkville"). Under the terms of the agreement, Biotie has the option, at the sole and exclusive discretion of the Company, to take up YA Global's commitment to subscribe and pay for ordinary no-par Biotie shares up to a total value of 20 million euro over a period of 36 months. Timo Veromaa, Biotie's President and CEO:"We are pleased with the progress that we have made this quarter, including the initiation of an additional Phase I trial with our PDE4 inhibitor and having achieved an important milestone in our Wyeth collaboration. Additionally, our other programs remain on track, including nalmefene phase III clinical studies and our VAP-1 antibody Phase Ib studies. Furthermore, the secured equity distribution agreement with Yorkville provides us with added financial flexibility to raise funds through equity issues at our discretion. Strengthening of our financial position while advancing the development of our key R&D programs remains the focus of the company for the near and mid term." About Biotie Therapies 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. Current Status of Drug Development Projects in Clinical or Pre-clinical Stages: 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. At the end of 2008, licensing partner Lundbeck launched three phase III trials, which seek to enroll about 1,800 patients. The first two trials, in which patients are treated over a period of six months, serve to confirm the efficacy of Nalmefene, whilst the objective of the last study, in which patients are treated for 12 months, is to assess the safety and tolerability of the compound. We expect preliminary trial data to become available during the first half of 2011. Biotie is participating in financing some of the clinical development costs. Lundbeck has worldwide rights for Nalmefene, excluding South-Korea. Under the terms of the Biotie-Lundbeck license agreement, Biotie is eligible for up to EUR 84 million in upfront and milestone payments plus royalties on sales. 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. ELB353 has been well tolerated in a Phase I single and multiple dosing study, particularly with respect to central nervous system and gastrointestinal side effects, areas which have posed significant development hurdles for PDE4 inhibitors in the past. Furthermore, blood plasma profiles of ELB353 showing pronounced and long lasting exposure support once-daily dosing. Biotie is currently conducting a clinical study with ELB353 within the European Union with the aim to evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of repeated doses of ELB353 in up to 48 healthy volunteers. The study is expected to provide proof of pharmacodynamic activity in humans, corroborate the safety profile and establish dose ranges for further therapeutic studies. Results are expected in the first half of 2010. VAP-1, a key inflammation receptor. Vascular Adhesion Protein-1 (VAP-1) is Biotie's proprietary target. VAP-1 has been shown to play a key role in mediating the inflammatory events associated with chronic diseases such as rheumatoid arthritis, psoriasis and diabetes. VAP-1 also may be potentially applicable to other chronic inflammatory diseases for which there is a clear unmet medical need. 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. Biotie completed the first-in-man, single dose, placebo-controlled clinical study with the VAP-1 antibody in 2008 and is now conducting two multiple dose clinical studies in rheumatoid arthritis and psoriasis patients, which were respectively initiated in February and March 2009. These studies aim to establish appropriate dosing regimens for subsequent therapeutic studies and provide initial information on the antibody's therapeutic potential. In 2006, Biotie and Roche have signed an option agreement for Biotie's fully human antibody program targeting VAP-1 in inflammatory disease. Roche has paid Biotie a EUR 5 million option fee, which grants Roche an option right to an exclusive, worldwide license agreement for Biotie's VAP-1 antibody, excluding Japan, Taiwan, Singapore, New Zealand, and Australia. The initial option right will end upon completion of the ongoing phase I studies. Seikagaku Corporation has licensed 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. Biotie has already received USD 2.7 million from Seikagaku. VAP-1 SSAO inhibitors. Biotie and Roche also collaborate on the development of small molecule VAP-1 SSAO inhibitors. Under the terms of the collaboration, both parties carry their own costs, but Biotie retains ownership of the developed compounds until Roche chooses to exercise its option for in-licensing. Under the terms of the collaboration and option agreement, Roche may pay Biotie up to EUR 5 million to maintain its exclusive option for rest-of-world rights excluding Seikagaku's territory (Japan, Taiwan, Singapore, New Zealand and Australia). Seikagaku has an option to license a VAP-1 enzyme inhibitor in its territory. If Seikagaku exercises its option, Biotie will receive up to USD 16.7 million in milestone payments plus royalties on sales in the territory based on the pre-negotiated licensing agreement. Seikagaku will also be responsible for clinical development costs to bring the product to market in the territory. 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. The PDE10 discovery and development program is partnered with Wyeth Pharmaceuticals since December 2006. In August 2009, Biotie reached a milestone in its collaboration with Wyeth, triggering a USD 1.0 million milestone payment. According to the agreement with Wyeth, Biotie is eligible for up to USD 110 million in signing fee, milestone payments and research funding. Biotie will in addition be eligible for royalties on sales. Revenues Revenue for the period of January 1 to September 30 amounted to EUR 4.5 million (in the same period 2008, EUR 4.0 million). Revenue consisted of milestone payment and income from the ongoing research collaboration with Wyeth as well as periodization of previously received up-front payments of the licensing agreements the company has in place with several licensing partners. In August 2007, the central development agency for the state of Saxony (Sächsische Aufbaubank, SAB) awarded a research and technology grant for drug discovery and early development activities to the German subsidiary Biotie Therapies GmbH in the amount of EUR 3.8 million. The money has been awarded as a non-refundable grant to be drawn down during the period between August 2007 and July 2010 against reported realized costs. As of September 30, EUR 1.4 million of this grant were still available to the company. The grant covers 65% of personnel and project related cost, so Biotie Therapies GmbH must show a total expenditure of EUR 2.4 million until July 2010 in relation to the research projects in order to benefit from the full amount still available. Payments to Biotie Therapies GmbH in relation to this grant are reported as other operating income. Financial results The net loss for the reporting period was EUR 8.3 million excluding extraordinary items in relation to write-offs of intangible assets. Total net loss for January-September 2009 including extraordinary items amounted to EUR 12.1 million. The corresponding loss for the previous year was EUR 3.8 million, no extraordinary items were reported. Research and development costs for the period amounted to EUR 11.3 million, excluding extraordinary items (in 2008 EUR 6.3 million). Impairment losses were recorded due to the decision of the Board of Directors as of August 6, 2009 to pool capacities for the development of the more advanced projects and terminating active development of the immunosuppression program (EUR 1,0 million), termination of the development of the Buprenorphine Depot product (EUR 2 million), termination of the HCV infection program after the termination of the license agreement with Gilead, and subsequent winding down of Biotie's wholly owned Belgian subsidiary 4AZA IP NV (EUR 2,4 million). Patent costs have been booked as expenses and were not capitalized. Financing Cash and cash equivalents totaled EUR 16.7 million on September 30, 2009 (EUR 21.0 million on September 30, 2008). The company has predominantly invested its liquid assets into bank deposits and money market funds. 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". Money market funds are reported at fair value in financial assets at fair value through profit or loss. In September 2008, The Finnish Funding Agency for Technology and Innovation (Tekes) granted EUR 0.6 million additional funding for Biotie Therapies' VAP-1 antibody program. The R&D funding granted covers drug development costs of the project from August 2008 to December 2009. The funding granted is in the form of a loan and it covers about 70 per cent of the costs of the project. The loan will be paid to Biotie against reported realized costs. In order to receive the full amount of granted financing, Biotie must show a total expenditure of EUR 0.8 million in the project. In January 2008, The Finnish Funding Agency for Technology and Innovation (Tekes) granted EUR 1.7 million additional funding for Biotie Therapies' integrin alpha2beta1 inhibitor program for thrombosis. The R&D funding granted covers drug development costs of the project from July 2007 to December 2009. The funding granted is in the form of loan and it covers 50 per cent of the costs of the project. The loan will be paid to Biotie against reported realized costs. In order to receive the full amount of granted financing, Biotie must show a total expenditure of EUR 3.4 million in the project. Shareholder's equity The shareholders' equity of the group amounts to EUR -11.8 million. Biotie's equity ratio was -41.0 % on September 30, 2009 (-64.0 % in 2008). According to Finnish Accounting Standards (FAS), shareholders' equity is less than half of the parent company's share capital. The company's share capital is EUR 44.3 million, shareholders' equity is EUR 7.8 million and capital loans stand at EUR 21.3 million. Thus, shareholders' equity plus capital loans add up to EUR 29.1 million. The Company does not have funds that could be used for profit distribution. Investments and cash flow The cash flow from operations was EUR -8.8 million for January - September 2009 (comparable period in 2008 EUR -7.9 million). The group's investments during the reporting period amounted to EUR 426 thousand (EUR 110 thousand in 2008). Personnel During the reporting period January - September 2009, the company's personnel was on average 81(35 during January - September, 2008) and at the end of the reporting period 83 (34 on September 30, 2008). The increase is due to the inclusion of the German subsidiary, which was acquired in November 2008. Extraordinary General Meeting On September 28, the Board of Directors resolved to call an Extraordinary General Meeting of shareholders to be held on October 29, 2009. It proposes to elect Dr. Peter Fellner as new member of the Board of Directors. Furthermore, it proposes to authorize the Board of Directors to resolve on one or more issues which contains the right to issue new shares or dispose of the shares in the possession of the company and to issue options or other specific rights to the shares pursuant to chapter 10 of the Companies Act. The authorisation would consist of up to 72,000,000 shares in the aggregate and would supersede earlier authorizations. The authorisation is proposed to be used for material arrangements from the company's point of view, such as financing or implementing business arrangements or investments or for other such purposes determined by the Board of Directors in which case a weighty financial reason for issuing shares, options or other specific rights and possibly directing a share issue would exist. The authorisation could not, however, be used to create new share-based incentive schemes. Due to the recent amendment to the Finnish Companies Act, the Board also proposes to amend the articles of association accordingly. Group structure The parent company of the group is Biotie Therapies Corp. The domicile of the Company is Turku, Finland. The group has an operative subsidiary, Biotie Therapies GmbH, located in Radebeul, Germany. During Q3 2009, Biotie Therapies GmbH has wound down its former non-operating subsidiary, 4AZA IP NV of Leuven, Belgium. 4AZA IP was a special purpose vehicle whose sole activity was the holding of certain intellectual property rights, which the Company decided to abandon. The parent company also has a non-operational subsidiary named Biotie Therapies International Ltd in Finland and an associated company with no activities, Contral USA which is domiciled in Delaware, USA. Share capital and Shares Biotie's shares are quoted on the NASDAQ OMX Helsinki Ltd (Small cap, Healthcare). Biotie Therapies has 144,320,560 shares outstanding and the share capital amounts to EUR 44,290,678.10 (under Finnish Accounting Standards, FAS). All the company's shares are of the same series and have equal rights. All the shares are freely transferable and contain one voting right each. The company has in its possession 819.000 of its own shares. The company has a stock lending agreement with EVLI Bank in place in relation to the company's option programs. Pursuant to this agreement, the number of the company's own shares in its possession may be temporarily less than 819,000. At the end of September the share price was EUR 0.58, the highest price during January - September was EUR 0.67, the lowest was EUR 0.23, and the average price was EUR 0.38. Biotie's market capitalization at the end of September was EUR 83.7 million. The trading volume on NASDAQ OMX Helsinki during the reporting period January - September was 29,903,949 shares, corresponding to a turnover of EUR 10.89 million. LP market making agreement with Nordea Biotie and Nordea Bank Finland Plc concluded a market making agreement, which fulfils the requirements of NASDAQ OMX Helsinki Ltd's Liquidity Providing (LP) operations. The market making agreement aims at increasing the share's liquidity and decreasing the share price volatility thus facilitating trading. According to the agreement, Nordea will provide Biotie's share with bids and offers so that the maximum spread is 4% calculated from the bid quotation. Bids or offers include at least 4,000 shares and the value of the shares must correspond to at least 4,000 euros. Nordea undertakes to submit bids and offers for Biotie's share on the official list in the trading system of NASDAQ OMX Helsinki on each trading day for at least 85 per cent of the time of continuous trading, at the opening and closing call of the trading day and in the auction procedures applicable to the share during a trading day. The market making in accordance with the agreement began on September 24, 2009. After a 6-month term, the market making agreement is valid until further notice. The term of notice of the agreement is one month. Changes in ownership Biotie has on February and July, 2009 gained knowledge of the notifications regarding the following changes in holdings in accordance with Chapter 2, Section 9 of the Finnish Securities Markets Act Information on notices of change in ownership are available on the company's website at 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, the strategic decisions of its commercial partners, ability to obtain and maintain intellectual property rights for its products, validity of its patents, launch of competitive products and the development of the sales of its products and availability of funds to support its operations. For example, even though the commercialization and collaboration agreements on the company's product development projects have been concluded, there can be no assurance that the contracting partner will act in accordance with the agreement, the authorities will approve the product under development or the approved product will be commercialized. The development and success of the company's products depends to a large extent on third parties. Any adverse circumstance in relation to any of its R&D programs might jeopardize 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 assets in relation to intellectual property rights) and dependency on its license partners' decisions. Significant financial resources are required to advance the drug development programs into commercialized pharmaceutical products. To fund the operations, the group relies on its ability to secure financing from four major sources: income from its license partners, grant income, loans from TEKES and raising equity financing in the capital markets. Entering into commercialization, collaboration and licensing agreements with larger pharmaceutical companies entitles the Company and its subsidiaries to receive up-front, milestone dependent and royalty payments from these partners. Although Biotie has currently several active license agreements in place, any decision by one of its partners to terminate an agreement would have a negative effect on the short to medium term access to liquidity of the Company. In addition, the Company relies on different sources of research and development grants and loans. These funds, which are provided through regional, national or EU level institutions with the aim of fostering economic and technological progress in the region in which the group operates, have been historically available to Biotie at substantial levels. Availability of such funds in the mid- to long term future cannot be guaranteed and thus this poses a potential risk to the income situation of the group in the future. Income and loans from such sources have been secured until 2009. So far, the Company has no indication that this source of financing will be available beyond 2009. Furthermore, the Company relies on capital market to raise equity and debt financing from time to time. There can be no assurance that sufficient financing 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 from capital markets. 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. Events after the reporting period The Company has entered into a Standby Equity Distribution Agreement with YA Global Master SPV Ltd. ("YA Global") a fund managed by Yorkville Advisors, LLC of Jersey City, New Jersey, USA ("Yorkville"). Under the terms of the agreement, Biotie has the option, at the sole and exclusive discretion of the Company, to take up YA Global's commitment to subscribe and pay for ordinary no-par Biotie shares up to a total value of 20 million euro over a period of 36 months. At any time during the 36 month commitment period, Biotie may require YA Global to purchase newly issued Biotie shares or shares Biotie has in its own possession by delivering an advance notice to YA Global designating requested portion of the commitment amount to be taken up. The maximum portion of the commitment amount to be used at a time is 50,000 euro for the first tranche, 100,000 euro for the second tranche and 300,000 euro for the subsequent tranches. The number of shares issuable to YA Global shall, however, in no event cause the aggregate number of shares beneficially owned by YA Global and its affiliates to exceed 4.99% of the then issued shares. Further, in no event shall the aggregate number of shares issued by Biotie to YA Global exceed 9.9% of all outstanding shares of Biotie during a rolling twelve month period unless Biotie ensures that all shares issued despite exceeding the threshold are or will be admitted for listing. The pricing of the shares will be determined as 95% of the lowest daily volume-weighted average share price of the five trading days following the date on which Biotie shall have sent to YA Global the relevant advance notice, and may in no event be less than 85% of the daily volume-weighted average price of Biotie shares on NASDAQ OMX Helsinki Ltd. on the last trading day prior to such date of advance notice ("Minimum Price"). Further, should the market price on certain of the five trading days following the date of advance notice fall below the Minimum Price, the pro rata subscription for such days will not be executed unless YA Global decides to execute such subscription at the Minimum Price. The purpose of the Standby Equity Distribution Agreement is to secure the financing of Biotie's working capital in the short and medium term. In consideration of the committed standby equity Biotie will pay to YA Global a one-time commitment fee of 200.000 euro, payable in Biotie shares, as well as a structuring fee and a due diligence fee. Future outlook - During 2009, Biotie will provide support to its license partner Lundbeck for the ongoing phase III studies with Nalmefene in alcohol dependence. - Biotie will continue to perform two clinical studies with its proprietary VAP-1 antibody in psoriasis and rheumatoid arthritis patients in the course of 2009. Results of these studies will become available in the first half of 2010. - The company will continue to conduct a clinical trial for its proprietary, small molecule PDE-4 inhibitor ELB353 with the aim to obtain proof of pharmacodynamic activity in humans, corroborate the safety profile and establish dose ranges for further therapeutic studies. - In its collaboration with Wyeth on the discovery and development of novel PDE10 inhibitors for the treatment of psychiatric disorders, Biotie and its partner intend to identify further development candidates. - Due to the increased clinical trial activity it is foreseeable that the company's R&D expenses (excluding the extraordinary impairment costs) will increase in comparison to previous financial year. At the same time, income will also be higher due to the additional income generated through the company's newly acquired subsidiary. Overall, negative cash flow from operational activities is expected to moderately increase in comparison to previous financial year. Next financial report Biotie's financial statement release 2009 will be published on February 26, 2010. IFRS and Accounting principles The 2009 interim report has been prepared in accordance with IFRS recognition and measurement principles, and applying the same accounting policy as for the 2008 financial statements. In addition, the changes in the presentation of statement of comprehensive income and the statement of changes in equity according to the revised IAS 1 have been applied in the interim report. The IFRS 8 'operating segments' standard does not have an impact on the presentation of the Group's financial statements since the Group is operating as one segment. The interim report has not been prepared in accordance with IAS 34, Interim Financial Reporting. Financial statements for the period from January 1, 2009 to September 30, 2009 are not directly comparable to those of the same period in 2008 due to the inclusion of the operating result of the wholly owned subsidiary Biotie Therapies GmbH (formerly elbion GmbH) in 2009. This interim report is unaudited. In Turku, October 23, 2009 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 CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME (IFRS) 1.7.- 1.7.- 1.1.- 1.1.- 1.1.- 30.9.2009 30.9.2008 30.9.2009 30.9.2008 31.12.2008 EUR 3 months 3 months 9 months 9 months 12 months 1,000 Revenue 1,792 791 4,532 3,950 5,127 Research and -3,828 -1,076 -16,741 -6,276 -8,730 development expenses General and -804 -302 -2,703 -1,201 -2,020 administrative expenses Other operating 443 59 1,203 179 502 income Other operating -29 -41 0 expense Operating -2,426 -528 -13,750 -3,348 -5,121 profit/loss Financial income 125 273 571 508 1,432 Financial expenses -215 -245 -759 -962 -1,864 Profit/loss before -2,516 -500 -13,938 -3,802 -5,553 taxes Taxes 0 0 1,859 0 76 Net income/loss -2,516 -500 -12,079 -3,802 -5,477 Total -2,516 -500 -12,079 -3,802 -5,477 comprehensive income of the period Net income/loss attributable to Parent company -2,516 -500 -12,079 -3,802 -5,477 shareholders Total comprehensive income attributable to: Parent company -2,516 -500 -12,079 -3,802 -5,477 shareholders Earnings per share -0.02 -0.01 -0.08 -0.04 -0.06 (EPS) basic & diluted, EUR CONSOLIDATED STATEMENT OF FINANCIAL POSITION (IFRS) EUR 1,000 30.9.2009 30.9.2008 31.12.2008 Assets Non-current assets Intangible assets 7,194 707 10,352 Goodwill 379 0 379 Property, plant and equipment 2,782 350 2,792 Other shares 10 0 0 10,365 1,057 13,523 Current assets Prepaid expenses 0 0 2,400 Available for sale investment 131 0 131 Investments held to maturity 6,000 18,300 18,500 Accounts receivables and other 1,642 1,181 1,512 receivables Financial assets at fair value 3,028 0 0 through profit or loss Cash and cash equivalents 7,673 2,667 6,738 18,474 22,148 29,281 Total 28,839 23,205 42,804 Equity and liabilities Shareholders' equity Share capital 36,361 19,779 36,361 Reserve for invested unrestricted 980 980 980 equity Retained earnings -37,073 -31,808 -31,754 Net income/loss -12,079 -3,802 -5,477 Shareholders' equity total -11,811 -14,852 110 Non-current liabilities Provisions 143 0 121 Non-current financial liabilities 25,431 24,472 24,930 Pension benefit obligation 593 0 574 Other non-current liabilities 6,544 5,602 5,881 Non-current deferred revenues 1,849 3,035 2,966 Deferred tax liabilities 0 1,859 34,560 33,109 36,331 Current liabilities Provisions 607 18 641 Pension benefit obligation 17 0 10 Current financial liabilities 209 143 144 Current deferred revenues 2,140 1,175 3,501 Accounts payable and other current 3,117 3,612 2,067 liabilities 6,090 4,948 6,363 Liabilities total 40,650 38,057 42,694 Total 28,839 23,205 42,804 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 90,212 19,850 980 -15 -31,930 -11,117 1.1.2008 Total -3,802 -3,802 comprehensive income for the period Options granted 138 138 Cost of share -71 -71 issue 0 -71 0 0 -3,664 -3,735 BALANCE AT 90,212 19,779 980 -15 -35,594 -14,852 30.9.2008 Total -1,675 -1,675 comprehensive income for the period Options granted 55 55 Share issue 54,109 16,873 16,873 Cost of share -291 -291 issue 54,109 16,582 0 0 -1,620 14,962 BALANCE AT 144,321 36,361 980 -15 -37,215 110 31.12.2008 Total -12,079 -12,079 comprehensive income for the period Options granted 158 158 0 0 0 0 -11,921 -11,921 BALANCE AT 144,321 36,361 980 -15 -49,136 -11,811 30.9.2009 CONSOLIDATED STATEMENT OF CASH FLOWS 1.1.- 1.1.- 1.1.- 30.9.2009 30.9.2008 31.12.2008 EUR 1,000 9 months 9 months 12 months Cash flow from operating Activities Net income/loss -12,079 -3,802 -5,477 Adjustments: Non-cash transactions 3,724 238 -4,303 Addition/disposal due to -28 0 0 revaluation of financial assets at fair value through profit or loss Interest and other 775 962 1,863 financial expenses Interest income -587 -508 -1,431 Taxes -1,859 0 -76 Change in working capital: Change in accounts receivables and -48 -44 446 other receivables Change in accounts payable and 1,039 -4,732 -277 other liabilities Change in mandatory provisions -11 -15 -152 Interests paid -107 -5 -29 Interests received 430 39 66 Taxes paid -5 0 0 Net cash from operating activities -8,757 -7,867 -9,370 Cash flow from investing activities Acquisition of subsidiary, net of cash 0 0 1,881 acquired Change in financial assets at fair value through profit or loss Additions -3,000 0 0 Disposals 0 27,685 27,685 Change in investments held to maturity Additions -900 -21,800 -46,300 Disposals 13,400 3,598 28,321 Investments to tangible assets -116 -28 -34 Net cash used in investing activities 9,384 9,456 11,553 Cash flow from financing activities Payments from share issue 0 0 3,300 Share issue costs 0 -71 -362 Proceeds from borrowings 421 888 1,374 Repayment of loans -40 -40 -40 Repayment of lease -72 -4 -21 Commitments Net cash from financing activities 309 774 4,250 Net increase (+) or decrease (-) 936 2,362 6,433 in cash and cash equivalents Cash and cash equivalents in the 6,738 305 305 beginning of the period Cash and cash equivalents in the 7,673 2,667 6,738 end of the period Contingent liabilities EUR 30.9.2009 30.9.2008 31.12.2008 1,000 Operating lease 124 146 commitments 123 Due within a year 81 69 64 Due later 43 77 59 Rent commitments 415 570 532 Due within a year 233 233 233 Due later 182 337 299 Total 539 716 655 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 September 30, 2009 Biotie had purchase commitments, primarily for contract research work services, totaling EUR 7.3 million. KEY FIGURES 1.1.- 1.1.- 1.1.- 30.9.2009 30.9.2008 31.12.2008 EUR 1,000 9 months 9 months 12 months Business development Revenues 4,532 3,950 5,127 Personnel on average 81 35 42 Personnel at the end of period 83 34 80 Research and development costs 16,741 6,276 8,730 Capital expenditure 426 110 116 Profitability Operating profit/loss -13,750 -3,348 -5,121 as percentage of revenues, % -303.4 -84.8 -99.9 Profit/loss before taxes -13,938 -3,802 -5,553 as percentage of revenues, % -307.5 -96.3 -108.3 Balance sheet Cash and cash equivalents 16,701 20,967 25,238 Shareholders equity -11,811 -14,852 110 Balance sheet total 28,839 23,205 42,804 Financial ratios Return on equity, % - - - Return on capital employed, % -71.9 -33.9 -18.3 Equity ratio, % -41.0 -64.0 0.3 Gearing, % -75.7 -24.6 -148.5 Per share data Earnings per share (EPS) basic & -0.08 -0.04 -0.06 diluted, EUR Shareholders'equity per share, EUR -0.08 -0.17 0.0008 Dividend per share, EUR Pay-out ratio, % Effective dividend yield, % P/E-ratio Share price Lowest share price, EUR 0.23 0.47 0.24 Highest share price, EUR 0.67 0.94 0.94 Average share price, EUR 0.38 0.67 0.51 End of period share price, EUR 0.58 0.48 0.26 Market capitalization 83.7 43.3 37.5 at the end of period MEUR Trading of shares Number of shares traded 29,903,949 8,542,915 15,350,613 As percentage of all 20.7 9.5 10.6 Adjusted weighted average 144,320,560 90,211,860 96,734,553 number of shares during the period Adjusted number of shares 144,320,560 90,211,860 144,320,560 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 |
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