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2010-10-29 08:02:00 CEST 2010-10-29 08:03:07 CEST REGULATED INFORMATION Biotie Therapies - Interim report (Q1 and Q3)Biotie Therapies interim report: January - September 30, 2010BIOTIE THERAPIES CORP. INTERIM REPORT 29 October, 2010 at 9.00 a.m. Biotie Therapies interim report: January - September 30, 2010 - Today, Biotie announced that it will focus the future business of the company exclusively on clinical development of nalmefene, ronomilast and VAP-1 antibody and will implement a restructuring plan leading to annual cost reduction of at least EUR 4 million and transfer of all operations to its headquarters in Finland. Biotie expects to have approximately 22 employees going forward. - As part of the restructuring plan, Biotie will spin-off its site in Radebeul, Germany in an MBO transaction and will take a minority interest in the spin-off company, biocrea GmbH ("biocrea"). Thomas Kronbach, Biotie's Chief Scientific Officer, will leave Biotie to become Managing Director of the new entity, into which all employees and all pre-clinical assets of Biotie Therapies GmbH (Biotie's subsidiary in Radebeul, Germany) will be transferred. - Also as part of the restructuring plan, Biotie will start a company-wide regulated co-determination process with employees in Finland regarding a potential reduction of headcount by up to 15 employees; while maintaining core competencies in clinical development and business operations. - Today, Biotie announced that relating to the planned re-structuring the research and option agreement with Roche for the development of small molecule inhibitors of SSAO (semicarbazide-sensitive amine oxidase) has been terminated by mutual agreement. - After the reporting period, on October 15, Biotie reported that it regained rights from Pfizer to compounds relating to PDE10 inhibition for the treatment of CNS disorders. This asset will be transferred to the newly created spin-off company, biocrea. - On September 14, Biotie reported top-line data from a phase I study with its fully human VAP-1 monoclonal antibody (BTT-1023) in patients with plaque psoriasis. BTT-1023 continues to demonstrate favourable safety profile. In January 2010, Biotie reported positive data from a phase I clinical study with the VAP-1 antibody in rheumatoid arthritis patients. - On April 26, Biotie announced positive data from a clinical study with its oral PDE4 inhibitor in healthy volunteers. Ronomilast (previously known as ELB353) was well tolerated and showed clear pharmacological activity. Enabling work for a phase II program has been initiated. - After the reporting period, on October 25, Biotie reported on an issue of 17,251,371 shares to the company itself without consideration for the purpose of potentially selling such shares to Yorkville pursuant to the terms of the standby equity distribution agreement ("SEDA") in place. No decision on an offer to sell treasury shares to Yorkville has been made yet. A prospectus concerning Biotie's issue of shares to the company itself has been published on that day. - On August 26, Biotie reported a directed issue of shares pursuant to the SEDA, offering 114,233 treasury shares to Yorkville against cash payment of EUR 50,000 at a subscription price of EUR 0.44. - Due to the potential implementation of restructuring plan to focus on clinical development, income statement and cash flow items as well as assets and liabilities related to company´s pre-clinical development have been separated as assets held for sale and discontinued operations - Revenues for continuing operations in January - September amounted to EUR 1.5 million (EUR 2.5 million in 2009), and EUR 1.0 million for the discontinued operations (EUR 2.0 million in 2009). Net loss for continuing operations in January - September was EUR 6.0 million (EUR 5.7 million in 2009). Net loss for discontinued operations in January - September excluding extraordinary items in relation to write-offs of intangible assets and goodwill was EUR 4.1 million (EUR 2.6 million in 2009). Net loss for discontinued operations in January- September 2010 including extraordinary items in relation to write-offs of intangible assets was EUR 7.0 million (EUR 6.4 million in 2009). Basic earnings per share amounted to EUR -0.04 for the continuing operations (EUR -0.04 for 2009) and EUR -0.04 for the discontinued operations (EUR -0.04 for 2009). - Cash flow from operations in January - September amounted to EUR -7.1 million for the continuing operations (EUR -6.7 million in 2009) and EUR -3.4 million for the discontinued operations (EUR -2.1 million in 2009). As of 30 September, liquid assets amounted to EUR 8.9 million (EUR 16.7 million as of 30 September 2009). Q3/2010 in brief: - Revenues for July - September, 2010 amounted to EUR 0.5 million, all from continuing operations. Revenues for the comparable period in 2009 amounted to EUR 0.7 million for continuing operations and EUR 1.1 million for discontinued operations. The net loss for continuing operations in July - September was EUR 1.4 million (EUR 2.0 million in 2009). Net loss for discontinued operations excluding extraordinary items in relation to write-offs of certain intangible assets and goodwill was EUR 1.6 million (EUR 0.5 million in 2009). Net loss for discontinued operations in July - September including extraordinary items amounted to EUR 4.5 million (EUR 0.5 million in 2009). Basic earnings per share for July - September amounted to EUR -0.01 for the continuing operations (EUR ‑0.01 in 2009) and EUR -0.03 for the discontinued operations (EUR 0.00 in 2009). - Cash flow from operating activities in July - September was EUR -2.4 million (EUR -2.1 million during July - September 2009). Timo Veromaa, Biotie's President and CEO:"We are confident that the steps we would be taking today would allow us to focus on our core competencies and to efficiently advance our existing clinical pipeline. We also believe to be better positioned to secure additional funding from capital markets in the future, either by making use of the SEDA in place with Yorkville or otherwise. The resulting streamlined organization and corporate structure would enable us to build a stronger clinical pipeline and additionally consider other strategic options to deliver longer-term sustainable growth going forward. We look forward to the upcoming results from the ongoing phase III trials of nalmefene in alcohol dependence and remain enthusiastic about the differentiated profile of our oral PDE-4 inhibitor, ronomilast, and by the broad potential of our VAP-1 antibody for the treatment of inflammatory disorders". Outlook for 2010 - Biotie will continue to support its licensing partner Lundbeck in the development of nalmefene for the treatment of alcohol dependence. Phase III clinical data from 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. While the rights to the product in Japan, Taiwan, Singapore, Australia and New Zealand have been granted to Seikagaku, Biotie retains ownership in the rest of the world and will be looking for additional collaboration opportunities. - Biotie intends to continue active development of ronomilast for the treatment of COPD. Further clinical trials are planned and Biotie will be looking for potential collaboration opportunities for this product. - Biotie will need to secure its working capital beyond Q2 2011 in order to execute its intended product development activities. Income generated from commercial agreements relating to Biotie's clinical programs may significantly improve the company's financial position, but no reliable forecast on any potential income from such commercial agreements can be provided. Biotie may therefore need to secure additional financing through the issue of shares, either by exercising its existing SEDA with Yorkville or through share issues to others. - The measures in connection to the restructuring plan will accelerate cash outflows in 2010 due to one-time payments in the amount of approx. EUR 2.5-3 million. Additional cash outflows of approx EUR 2-2.5 million will take place in future periods in connection with the restructuring plan. Financial calendar 2011 Next financial report Biotie's financial statement release 2010 will be published on February 25, 2011. Conference call An analyst and media conference call will take place on October 29, 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: US: +1 212 444 0894, UK: +44 (0)20 7138 0825 and Finland: +358 (0)9 2319 4344 access code 4085851. Lines are to be reserved ten minutes before the start of conference call. The event can also be viewed as a live webcast atwww.biotie.com. An on demand version of the conference will be published on Biotie´s website later during the day. 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 specialized drug development company focused on central nervous system and inflammatory diseases. It has several innovative small molecule and biological drug candidates at different stages of clinical development. Biotie's products address diseases with high unmet medical need and significant market potential, including addiction and a broad range of inflammatory conditions like rheumatoid arthritis or chronic obstructive pulmonary disease (COPD). The most advanced product, nalmefene for alcohol dependence, is currently in phase III clinical development by licensing partner H. Lundbeck A/S. 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 for Nalmefene to Lundbeck. Currently, Lundbeck is undertaking three phase 3 clinical trials with Nalmefene for the treatment of alcohol dependence. We expect top-line data from two of the ongoing clinical trials to become available towards the end of 2010. Biotie is participating in financing some of the clinical development costs. Ronomilast, an oral PDE4 inhibitor for COPD in clinical development. Ronomilast 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 respiratory disorder with major unmet medical need. In clinical studies with 84 study subjects ronomilast has been demonstrated to be safe and well tolerated at all tested doses up to 100mg once daily. No serious or severe adverse events were reported in any of the study subjects. Robust and statistically highly significant biomarker responses confirmed the pharmacological activity of well tolerated doses of ronomilast in man. Further clinical trials are planned and Biotie will be looking for potential collaboration opportunities for this product. 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 COPD, 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. Biotie previously reported that it has successfully completed a clinical trial with its VAP-1 antibody (BTT-1023) in rheumatoid arthritis patients, demonstrating the safety, tolerability, and pharmacokinetics of repeated doses of intravenously administered antibody in 24 rheumatoid arthritis patients who unresponsive to methotrexate therapy. 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 the 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. In September, Biotie reported top-line data from a phase I study with VAP-1 antibody in patients with plaque psoriasis in which study the product continues to demonstrate a favourable safety profile. The study evaluated the safety, tolerability, and pharmacokinetics of repeated doses of intravenously administered antibody in 26 patients with active plaque psoriasis. The antibody, administered at repeated doses of up to 8 mg/kg, was generally well tolerated, and the pharmacokinetic characteristics of BTT-1023 in psoriasis patients were consistent with those observed in a previously completed study in rheumatoid arthritis (RA) patients. The study was not designed to enable formal statistical evaluation of therapeutic activity. However, whereas no change in disease activity was noted during the treatment period in any patient receiving placebo, several patients on active drug experienced an improvement in their condition, reflected as decreases in their Psoriasis Area Severity Index (PASI) scores and physicians' clinical assessments. No PASI50 responses (50% decrease in PASI score) were observed within the relatively short treatment period. Two patients on active drug were reported to have experienced a transient exacerbation of their psoriasis symptoms that occurred after the treatment had been completed; apart from these two cases, no serious or severe adverse events were reported in the study subjects. Biotie has granted a license to Seikagaku Corporation for the commercial rights to the product in 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 is committed to continuing development of its VAP-1 antibody and preparatory activities towards the start of phase 2 studies are underway. If deemed necessary and if commercially attractive terms can be achieved, Biotie will seek development and commercial partners in addition to Seikagaku. VAP-1 SSAO inhibitors. This research program is currently at the pre-clinical stage. Biotie announced today that the research and option agreement with Roche for the development of small molecule inhibitors of SSAO has been terminated by mutual agreement enabling the company now to seek alternative ways to monetize this asset, such as asset sale or transfer of the technology. Biotie's option agreement with Seikagaku Corporation regarding the SSAO inhibitor program for Japan, Taiwan, Singapore, Australia and New Zealand remains in force. Biotie could receive up to $16.7 MM from a license agreement and would be eligible for royalties on future sales in the territory if Seikagaku exercises its option. Financial review On October 25 Biotie issued a restatement of its Q2 2010 interim report in which it corrected interpretation used in previous interim reports for the year 2010, according to which grants received from Sächsische Aufbaubank ("SAB") by its German subsidiary Biotie Therapies GmbH have been recognized as revenue. Pursuant to the corrected interpretation, the grants shall be recognized as other operating income. The figures published in this interim report are in line with the accounting treatment applied in the restated interim report and in previous years. Revenues: Revenues for continuing operations in January - September amounted to EUR 1.5 million (EUR 2.5 million in 2009), and EUR 1.0 million for the discontinued operations (EUR 2.0 million in 2009). Revenues consisted of income from the research collaboration with Pfizer and periodization of previously received up-front payments from licensing agreements that the company has in place with several licensing partners. Financial result: Net loss for continuing operations in January - September was EUR 6.0 million (EUR 5.7 million in 2009) and net loss for for discontinued operations including extraordinary items in relation to write-offs of intangible assets and goodwill was EUR 7.0 million (EUR 6.4 million in 2009). Research and development costs for the reporting period amounted to EUR 10.1 million (Research and development costs for the comparable period in 2009 amounted to EUR 11.3 million, excluding extraordinary items). Financing: Cash and cash equivalents totaled EUR 8.9 million on September 30 (EUR 16.7 million on 30 September, 2009). 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 equity distribution agreement (SEDA) 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. Biotie has made use of this arrangement the first time in August 2010. Shareholder's equity: The shareholders' equity of the group amounts to EUR -21.9 million (IFRS). Biotie's equity ratio was -127.5% on 30 September 2010 (-41.0% on 30 September 2009). Investments and cash flow: Cash flow from operations was EUR -10.5 million for January - September (EUR -8.8 million during January - September 2009). The group's investments during the reporting period amounted to EUR 264 thousand (EUR 426 thousand in 2009). Personnel During the reporting period January - September 2010, the company´s personnel average was 82 (81 during January - September, 2009) and at the end of the reporting period it was 81 (83 on 30 September, 2009) before the announced of restructuring plan including the spin-off of the German operations. Following the spin-off in Germany and execution of planned restructuring measures in Finland, Biotie expects its total number of employees going forward would be approximately 22. 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 (registered on October 12, 2010) is EUR 51,556,678.10 (FAS), the total number of shares is 176,003,931. Of these shares, 17,600,393 are owned by Biotie Therapies Corp. On August 26, Biotie reported a directed issue of shares pursuant to the SEDA , offering 114,233 treasury shares to Yorkville against cash payment of EUR 50,000 at a subscription price of EUR 0.44. The offer was made in order to strengthen Biotie's working capital and to provide further financing for the company's R&D programs. The subscription price of the new shares was registered in its entirety to the share capital of Biotie. After the reporting period, on October 25, Biotie reported on an issue of 17,251,371 shares to itself without consideration for the purpose of potentially selling such shares to Yorkville pursuant to the terms of the standby equity distribution agreement ("SEDA") in place. No decision on an offer to sell treasury shares to Yorkville has been made yet. If sold, the company will use these proceeds to secure financing of the company's working capital in the short and medium term. A prospectus concerning Biotie's issue of shares to the company itself has been published on that day. All shares were issued pursuant to the authorisation by the General Meeting of Shareholders of Biotie held on 15 April 2010. Changes in ownership From July to September 2010, Biotie made one announcement on 11 August according to Chapter 2, Section 10 of the Finnish Securities Market Act. Information on notices of changes in ownership and a monthly updated list of Biotie's major shareholders is 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, 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. To protect the continuity of Biotie's operations, it will need to secure its working capital beyond Q2 2011 in order to execute its intended product development activities. Although income generated from 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. Therefore it is possible that Biotie will need to secure additional financing from share issues, either through exercise of its existing SEDA with Yorkville or through share issues in the future. The group can influence the amount of capital used in its operations by adapting its cost base according to the financing available. The restructuring measures announced today highlight such an approach. 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. Assets are classified as held-for-sale according to IFRS 5. Non-current assets and discontinued operations are classified as held-for-sale and stated at the lower of carrying value and the fair value less cost to sell, if their carrying value is recovered principally through a sale transaction rather than through a continuing use. A discontinued operation results from the management's decision and commitment to dispose of a separate business for which the related assets, liabilities and operating results can be distinguished both operationally and for financial reporting purposes. When specific criteria for the held-for-sale classification has been met, the non-current assets are recorded at the lower of carrying value or fair value less cost to sell, and non-current assets subject to depreciation or amortization are no longer amortized. The assets and liabilities of a disposal group classified as held-for-sale are presented in the balance sheet separate from assets and liabilities related to continuing operations as of the date the operation qualified as discontinued. The results of discontinued operations, net of taxes and the gain or loss on their disposal are presented for all periods separate from continuing operations in the consolidated statements of income. Balance sheet data from periods preceding the qualifying disposal decision is not reclassified. This interim report is unaudited. Turku, October 29, 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 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.- 30.9.2010 30.9.2009 30.9.2010 30.9.2009 31.12.2009 EUR 1,000 3 months 3 months 9 months 9 months 12 months -------------------------------------------------------------------------------- Continuing operations Revenue 473 660 1,482 2,478 3,138 Research and -963 -1,920 -4,381 -5,624 -7,745 development expenses General and -784 -713 -2,713 -2,377 -3,434 administrative expenses Other operating income 41 11 125 25 242 -------------------------------------------------------------------------------- Operating profit/loss -1,233 -1,962 -5,487 -5,498 -7,799 Financial income 24 125 89 562 611 Financial expenses -207 -207 -615 -727 -932 -------------------------------------------------------------------------------- Profit/loss before taxes -1,416 -2,044 -6,013 -5,663 -8,120 -------------------------------------------------------------------------------- Net income/loss, continuing -1,416 -2,044 -6,013 -5,663 -8,120 operations -------------------------------------------------------------------------------- Discontinued operations Net income/loss, discontinued -4,504 -472 -7,000 -6,416 -7,963 operations -------------------------------------------------------------------------------- Net income/loss -5,920 -2,516 -13,013 -12,079 -16,083 Total comprehensive income of -5,920 -2,516 -13,013 -12,079 -16,083 the period Net income/loss attributable to Parent company shareholders -5,920 -2,516 -13,013 -12,079 -16,083 Total comprehensive income attributable to: Parent company shareholders -5,920 -2,516 -13,013 -12,079 -16,083 Earnings per share (EPS) -0,01 -0.01 -0,04 -0.04 -0.06 basic & diluted, EUR, continuing operations Earnings per share (EPS) -0,03 0.00 -0,04 -0.04 -0.06 basic & diluted, EUR, discontinued operations CONSOLIDATED STATEMENT OF FINANCIAL POSITION (IFRS) EUR 1,000 30.9.2010 30.9.2009 31.12.2009 -------------------------------------------------------------------------------- Assets Non-current assets Intangible assets 4,055 7,194 7,186 Goodwill 0 379 379 Property, plant and equipment 1,939 2,782 2,666 Other shares 10 10 10 -------------------------------------------------------------------------------- 6,004 10,365 10,241 Current assets Prepaid expenses 77 0 0 Available for sale investment 34 131 34 Investments held to maturity 3,000 6,000 0 Accounts receivables and other receivables 1,036 1,642 1,507 Financial assets at fair value through 0 3,028 8,853 profit or loss Cash and cash equivalents 5,924 7,673 10,891 Non-current assets classified as held for sale 1,104 0 0 -------------------------------------------------------------------------------- 11,175 18,474 21,285 Total 17,179 28,839 31,526 Equity and liabilities Shareholders' equity Share capital 42,925 36,361 43,057 Share issue 50 0 0 Reserve for invested unrestricted equity 1,180 980 1,180 Retained earnings -53,051 -37,073 -37,092 Net income/loss -13,013 -12,079 -16,083 -------------------------------------------------------------------------------- Shareholders' equity total -21,909 -11,811 -8,938 Non-current liabilities Provisions 4 143 160 Non-current financial liabilities 25,657 25,431 25,597 Pension benefit obligation 0 593 543 Other non-current liabilities 7,258 6,544 6,729 Non-current deferred revenues 399 1,849 1,375 -------------------------------------------------------------------------------- 33,318 34,560 34,404 Current liabilities Provisions 591 607 594 Pension benefit obligation 0 17 17 Current financial liabilities 171 209 217 Current deferred revenues 1,448 2,140 1,953 Accounts payable and other current liabilities 2,456 3,117 3,279 Liabilities associated with assets classified as 1,104 0 0 held for sale -------------------------------------------------------------------------------- 5,770 6,090 6,060 Liabilities total 39,088 40,650 40,464 Total 17,179 28,839 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 -13,013 -13,013 for the period Options granted 120 120 SEDA costs 4 4 Share issue 50 Cost of share issue -132 -132 -------------------------------------------------------------------------------- 0 -132 0 0 -12,889 -12,971 -------------------------------------------------------------------------------- BALANCE AT 30.9.2010 158,753 42,925 1,180 -15 -66,049 -21,909 -------------------------------------------------------------------------------- CONSOLIDATED STATEMENT OF CASH FLOWS 1.1.- 1.1.- 1.1.- 30.9.2010 30.9.2009 31.12.2009 EUR 1,000 9 months 9 months 12 months -------------------------------------------------------------------------------- Cash flow from operating activities Continuing operations Net income/loss -6,013 -5,663 -8,120 Adjustments: Non-cash transactions -1,154 -2,135 -2,654 Addition/disposal due to revaluation of 0 -28 -53 financial assets at fair value through profit or loss Interest and other financial expenses 612 727 931 Interest income -117 -577 -582 Change in working capital: Change in accounts receivables and other -158 157 280 receivables Change in accounts payable and other -255 428 527 liabilities Change in mandatory provisions -18 40 34 Interests paid -31 -59 -74 Interests received 56 420 31 -------------------------------------------------------------------------------- Net cash from operating activities, continuing -7,078 -6,691 -9,681 operations Net cash from operating activities, discontinued -3,444 -2,066 -3,645 operations -------------------------------------------------------------------------------- Net cash from operating activities -10,522 -8,757 -13,326 Cash flow from investing activities Continuing operations Change in financial assets at fair value through profit or loss Additions 0 -3,000 -9,000 Disposals 8,886 0 200 Change in investments held to maturity Additions -3,000 -900 -900 Disposals 0 13,400 20,142 Investments to tangible assets -53 -29 -35 -------------------------------------------------------------------------------- Net cash used in investing activities, continuing 5,834 9,471 10,406 operations Net cash used in investing activities, -211 -87 -130 discontinued operations -------------------------------------------------------------------------------- Net cash used in investing activities 5,623 9,384 10,277 Cash flow from financing activities Continuing operations Payments from share issue 50 0 7,216 Share issue costs -132 0 -520 Proceeds from borrowings 6 232 231 Repayment of loans -40 -40 -40 Repayment of lease commitments -132 -72 -86 -------------------------------------------------------------------------------- Net cash from financing activities, continuing -248 120 6,801 operations Net cash from financing activities, discontinued 180 189 401 operations -------------------------------------------------------------------------------- Net cash from financing activities -68 309 7,202 Net increase (+) or decrease (-) -4,967 936 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 5,924 7,673 10,891 end of the period DiSCONTINUED OPERATIONS On 28 October 2010, the board resolved to dispose of the Group's pre-clinical operations in Germany and in Turku. These operations which are expected to be sold in the near future have been classified as a disposal group held for sale and presented separately in the balance sheet. The proceeds of disposal are expected to be less than the book value of the related net assets and accordingly an impairment loss of EUR 2.9 million has been recognised on the classification of these operations as held for sale. The results of this business are reported within discontinued operations. The results of the discontinued operations as described above which have been included in the consolidated income statements are as follows: 1.1- 1.1-30.9.2009 1.1-31.12.2009 EUR 1,000 30.9.2010 ----------------------------------------------------------------------------- Result for discontinued operations Income from ordinary operations 2,065 3,241 3,882 Expenses -6,190 -11,516 -13,704 Result before taxes -4,125 -8,252 -9,822 Taxes 0 1,859 1,859 Result after taxes -4,125 -6,416 -7,963 Earnings due to discontinuation -2,875 0 0 ----------------------------------------------------------------------------- Result for discontinued operations -7,000 -6,416 -7,963 EUR 1,000 30.9.2010 ----------------------------------------------------------------------------- Assets held for sale Intangible assets 603 Tangible assets 501 Total assets 1,104 Liabilities held for sale Pension benefit obligations 576 Provisions 306 Other liabilities and accrued expenses 222 Total liabilities 1,104 Contingent liabilities EUR 1,000 30.9.2010 30.9.2009 31.12.2009 ---------------------------------------------------------- Operating lease commitments 124 124 137 Due within a year 81 81 88 Due later 43 43 49 Rent commitments 264 415 382 Due within a year 238 233 237 Due later 26 182 145 ---------------------------------------------------------- Total 388 539 519 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 September 30, 2010 Biotie had purchase commitments, primarily for contract research work services, totaling EUR 2.3 million. KEY FIGURES Incl. both continuing and discontinued 1.1.- 1.1.- 1.1.- operations 30.9.2010 30.9.2009 31.12.2009 EUR 1,000 9 months 9 months 12 months -------------------------------------------------------------------------------- Business development Revenues 2,455 4,532 5,628 Personnel on average 82 81 81 Personnel at the end of period 81 83 82 Research and development costs 10,148 16,741 21,109 Capital expenditure 264 426 475 Profitability Operating profit/loss -9,587 -13,750 -17,631 as percentage of revenues, % -390.5 -303.4 -313.27 Profit/loss before taxes -13,013 -13,938 -17,942 as percentage of revenues, % -530.1 -307.5 -318.80 Balance sheet Cash and cash equivalents 8,924 16,701 19,744 Shareholders equity -21,909 -11,811 -8,938 Balance sheet total 17,179 28,839 31,526 Financial ratios Return on equity, % - - - Return on capital employed, % -131.3 -71.9 -86.0 Equity ratio, % -127.5 -41.0 -28.4 Gearing, % -77,2 -75.7 -67.9 Per share data Earnings per share (EPS) basic & -0.08 -0.08 -0.11 diluted, EUR Shareholders´equity per share, EUR -0.14 -0.08 -0.0563 Dividend per share, EUR - Pay-out ratio, % - Effective dividend yield, % - P/E-ratio - Share price Lowest share price, EUR 0.41 0.23 0.23 Highest share price, EUR 0.65 0.67 0.67 Average share price, EUR 0.53 0.38 0.42 End of period share price, EUR 0.44 0.58 0.55 Market capitalization 69.9 83.7 87.3 at the end of period MEUR Trading of shares Number of shares traded 49,462,429 29,903,949 51,471,584 As percentage of all 31.2 20.7 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#1456968] |
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