Biotie Therapies Corp. interim report January 1 - September 30, 2009
(Thomson Reuters ONE) - BIOTIE THERAPIES CORP. INTERIM REPORT October 23, 2009at 8.30 a.m.Biotie Therapies Corp. interim report January 1 - September 30, 2009January - September 2009 in brief- In February and March, Biotie initiated two clinical studies inrheumatoid arthritis and psoriasis patients with its fully humanVAP-1 monoclonal antibody. Results from these studies are expected tobecome 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 (EUR4.0 million in 2008). Cash flow from operating activities in January- September was EUR -8.8 million (EUR -7.9 million for the sameperiod in 2008).- The net loss for January - September stood at EUR 8.3 million (netloss for comparable period in 2008 was EUR 3.8 million) excludingextraordinary items in relation to write-offs of certain intangibleassets. Total net loss for January - September includingextraordinary items in relation to write-offs of intangible assetswas EUR 12.1 million (net loss for January - September 2008 was EUR3.8 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 EUR16.7 million (EUR 21.0 million as of September 30, 2008).Q3/2009 in brief:- In August, the Board of Directors decided to pool capacities andstrengthen the Company's focus on the more advanced key research anddevelopment programs and to terminate the development of certainearly R&D programs as a result of the completion of the integrationprocess with the German subsidiary Biotie Therapies GmbH.- In August, Biotie reached a milestone in its collaboration withWyeth for the development of PDE10 (phosphodiesterase 10) inhibitorsfor schizophrenia, triggering a USD 1.0 million milestone payment toBiotie.- In September, Biotie started a clinical study with itsphosphodiesterase 4 (PDE4) inhibitor ELB353, with the goal toevaluate the safety, tolerability, pharmacodynamics andpharmacokinetics of repeated doses of oral ELB353 in up to 48 healthyvolunteers. Results are expected in the first half of 2010.- On September 28, the Board of Directors resolved to call anExtraordinary General Meeting of shareholders to be held on October29, 2009. Among others, it proposes to elect Dr. Peter Fellner as newmember of the Board of Directors.Furthermore, it proposes to authorize the Board of Directors toresolve on one or more issues which contains the right to issue newshares or dispose of the shares in the possession of the company andto issue options or other specific rights to the shares pursuant tochapter 10 of the Companies Act. The authorisation would consist ofup to 72,000,000 shares in the aggregate and would supersede earlierauthorizations. The authorisation is proposed to be used for materialarrangements from the company's point of view, such as financing orimplementing business arrangements or investments or for other suchpurposes determined by the Board of Directors in which case a weightyfinancial reason for issuing shares, options or other specific rightsand possibly directing a share issue would exist. The authorisationcould not, however, be used to create new share-based incentiveschemes.- In September Biotie and Nordea Bank Finland Plc concluded a marketmaking agreement. This agreement aims at increasing the share'sliquidity and decreasing the share price volatility thus facilitatingtrading.- Revenue for July - September stood at EUR 1.8 million (EUR 0.8million in 2008) and earnings per share was EUR -0.02 (EUR -0.01 in2008).- The net loss for July - September stood at EUR 2.5 million (netloss of comparable period in 2008 was EUR 0.5 million). Cash flowfrom 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 theshort and medium term, the Company has entered into a Standby EquityDistribution Agreement with YA Global Master SPV Ltd. ("YA Global") afund managed by Yorkville Advisors, LLC of Jersey City, New Jersey,USA ("Yorkville"). Under the terms of the agreement, Biotie has theoption, at the sole and exclusive discretion of the Company, to takeup YA Global's commitment to subscribe and pay for ordinary no-parBiotie shares up to a total value of 20 million euro over a period of36 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 PDE4inhibitor and having achieved an important milestone in our Wyethcollaboration. Additionally, our other programs remain on track,including nalmefene phase III clinical studies and our VAP-1 antibodyPhase Ib studies. Furthermore, the secured equity distributionagreement with Yorkville provides us with added financial flexibilityto raise funds through equity issues at our discretion. Strengtheningof our financial position while advancing the development of our keyR&D programs remains the focus of the company for the near and midterm."About Biotie TherapiesBiotie is a drug discovery and development company focused on centralnervous system and inflammatory diseases. It has a broad range ofinnovative small molecule and biological drug candidates at differentstages of clinical and pre-clinical development.Current Status of Drug Development Projects in Clinical orPre-clinical Stages:Nalmefene, a new treatment paradigm for alcohol dependence. Nalmefenebuilds on a novel principle of treating alcohol dependence. Unlikeexisting therapies, the treatment with Nalmefene is not aimed atkeeping the patients from drinking. Nalmefene instead removes thedesire to drink, thereby controlling and limiting the intake ofalcohol. Nalmefene distinguishes itself by being available as an oraltablet formulation to be taken on an as needed basis.At the end of 2008, licensing partner Lundbeck launched three phaseIII trials, which seek to enroll about 1,800 patients. The first twotrials, in which patients are treated over a period of six months,serve to confirm the efficacy of Nalmefene, whilst the objective ofthe last study, in which patients are treated for 12 months, is toassess the safety and tolerability of the compound. We expectpreliminary trial data to become available during the first half of2011. Biotie is participating in financing some of the clinicaldevelopment costs.Lundbeck has worldwide rights for Nalmefene, excluding South-Korea.Under the terms of the Biotie-Lundbeck license agreement, Biotie iseligible for up to EUR 84 million in upfront and milestone paymentsplus royalties on sales.ELB353, an oral PDE4 inhibitor for COPD in clinical development.ELB353 is a once-daily, oral phosphodiesterase 4 (PDE4) inhibitorwith therapeutic potential in chronic inflammatory disorders,particularly in chronic obstructive pulmonary disease (COPD), aserious disorder with major unmet medical need.ELB353 has been well tolerated in a Phase I single and multipledosing study, particularly with respect to central nervous system andgastrointestinal side effects, areas which have posed significantdevelopment hurdles for PDE4 inhibitors in the past. Furthermore,blood plasma profiles of ELB353 showing pronounced and long lastingexposure support once-daily dosing.Biotie is currently conducting a clinical study with ELB353 withinthe European Union with the aim to evaluate the safety, tolerability,pharmacodynamics and pharmacokinetics of repeated doses of ELB353 inup to 48 healthy volunteers. The study is expected to provide proofof pharmacodynamic activity in humans, corroborate the safety profileand establish dose ranges for further therapeutic studies. Resultsare 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 playa key role in mediating the inflammatory events associated withchronic diseases such as rheumatoid arthritis, psoriasis anddiabetes. VAP-1 also may be potentially applicable to other chronicinflammatory diseases for which there is a clear unmet medical need.VAP-1 function can be blocked by either antibody (biologic) drugs orsmall molecule drugs which target the enzyme (SSAO) domain of thereceptor. Both approaches are being pursued by Biotie for varioustherapeutic indications.VAP-1 antibody, a high value biologic for inflammatory diseases inclinical development. Biotie is developing a fully human monoclonalantibody which blocks VAP-1 function. Biotie completed thefirst-in-man, single dose, placebo-controlled clinical study with theVAP-1 antibody in 2008 and is now conducting two multiple doseclinical studies in rheumatoid arthritis and psoriasis patients,which were respectively initiated in February and March 2009. Thesestudies aim to establish appropriate dosing regimens for subsequenttherapeutic studies and provide initial information on the antibody'stherapeutic potential.In 2006, Biotie and Roche have signed an option agreement forBiotie's fully human antibody program targeting VAP-1 in inflammatorydisease. Roche has paid Biotie a EUR 5 million option fee, whichgrants Roche an option right to an exclusive, worldwide licenseagreement for Biotie's VAP-1 antibody, excluding Japan, Taiwan,Singapore, New Zealand, and Australia. The initial option right willend upon completion of the ongoing phase I studies.Seikagaku Corporation has licensed the rights for the product forJapan, Taiwan, Singapore, New Zealand, and Australia against up toUSD 16.7 million in milestone payments plus royalties on sales in theterritory. Biotie has already received USD 2.7 million fromSeikagaku.VAP-1 SSAO inhibitors. Biotie and Roche also collaborate on thedevelopment of small molecule VAP-1 SSAO inhibitors. Under the termsof the collaboration, both parties carry their own costs, but Biotieretains ownership of the developed compounds until Roche chooses toexercise its option for in-licensing. Under the terms of thecollaboration and option agreement, Roche may pay Biotie up to EUR 5million to maintain its exclusive option for rest-of-world rightsexcluding Seikagaku's territory (Japan, Taiwan, Singapore, NewZealand and Australia).Seikagaku has an option to license a VAP-1 enzyme inhibitor in itsterritory. If Seikagaku exercises its option, Biotie will receive upto USD 16.7 million in milestone payments plus royalties on sales inthe territory based on the pre-negotiated licensing agreement.Seikagaku will also be responsible for clinical development costs tobring the product to market in the territory.Phosphodiesterase 10 (PDE10) inhibitors, a novel treatment paradigmfor Schizophrenia. PDE10 is a novel molecular drug target inschizophrenia and Biotie has shown antipsychotic activity of PDE10inhibitors in animal models. Biotie's PDE10 inhibitors are believedto serve the unmet medical need for novel anti-psychotic drugs withan improved side effect profile and improved efficacy inschizophrenia.The PDE10 discovery and development program is partnered with WyethPharmaceuticals since December 2006. In August 2009, Biotie reached amilestone in its collaboration with Wyeth, triggering a USD 1.0million 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 beeligible for royalties on sales.RevenuesRevenue for the period of January 1 to September 30 amounted to EUR4.5 million (in the same period 2008, EUR 4.0 million). Revenueconsisted of milestone payment and income from the ongoing researchcollaboration with Wyeth as well as periodization of previouslyreceived up-front payments of the licensing agreements the companyhas in place with several licensing partners.In August 2007, the central development agency for the state ofSaxony (Sächsische Aufbaubank, SAB) awarded a research and technologygrant for drug discovery and early development activities to theGerman subsidiary Biotie Therapies GmbH in the amount of EUR 3.8million. The money has been awarded as a non-refundable grant to bedrawn down during the period between August 2007 and July 2010against reported realized costs. As of September 30, EUR 1.4 millionof this grant were still available to the company. The grant covers65% of personnel and project related cost, so Biotie Therapies GmbHmust show a total expenditure of EUR 2.4 million until July 2010 inrelation to the research projects in order to benefit from the fullamount still available. Payments to Biotie Therapies GmbH in relationto this grant are reported as other operating income.Financial resultsThe net loss for the reporting period was EUR 8.3 million excludingextraordinary items in relation to write-offs of intangible assets.Total net loss for January-September 2009 including extraordinaryitems amounted to EUR 12.1 million. The corresponding loss for theprevious year was EUR 3.8 million, no extraordinary items werereported. Research and development costs for the period amounted toEUR 11.3 million, excluding extraordinary items (in 2008 EUR 6.3million).Impairment losses were recorded due to the decision of the Board ofDirectors as of August 6, 2009 to pool capacities for the developmentof the more advanced projects and terminating active development ofthe immunosuppression program (EUR 1,0 million), termination of thedevelopment of the Buprenorphine Depot product (EUR 2 million),termination of the HCV infection program after the termination of thelicense agreement with Gilead, and subsequent winding down ofBiotie's wholly owned Belgian subsidiary 4AZA IP NV (EUR 2,4million).Patent costs have been booked as expenses and were not capitalized.FinancingCash 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 bankdeposits and money market funds. Bank deposits with maturity morethan 3 months are reported in "investments held to maturity" whereasdeposits with maturity less than 3 months are reported in the "cashand cash equivalents". Money market funds are reported at fair valuein financial assets at fair value through profit or loss.In September 2008, The Finnish Funding Agency for Technology andInnovation (Tekes) granted EUR 0.6 million additional funding forBiotie Therapies' VAP-1 antibody program. The R&D funding grantedcovers drug development costs of the project from August 2008 toDecember 2009.The funding granted is in the form of a loan and it covers about 70per cent of the costs of the project. The loan will be paid to Biotieagainst reported realized costs. In order to receive the full amountof granted financing, Biotie must show a total expenditure of EUR 0.8million in the project.In January 2008, The Finnish Funding Agency for Technology andInnovation (Tekes) granted EUR 1.7 million additional funding forBiotie Therapies' integrin alpha2beta1 inhibitor program forthrombosis. The R&D funding granted covers drug development costs ofthe project from July 2007 to December 2009.The funding granted is in the form of loan and it covers 50 per centof the costs of the project. The loan will be paid to Biotie againstreported realized costs. In order to receive the full amount ofgranted financing, Biotie must show a total expenditure of EUR 3.4million in the project.Shareholder's equityThe shareholders' equity of the group amounts to EUR -11.8 million.Biotie's equity ratio was -41.0 % on September 30, 2009 (-64.0 % in2008).According to Finnish Accounting Standards (FAS), shareholders' equityis less than half of the parent company's share capital. Thecompany's share capital is EUR 44.3 million, shareholders' equity isEUR 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 profitdistribution.Investments and cash flowThe cash flow from operations was EUR -8.8 million for January -September 2009 (comparable period in 2008 EUR -7.9 million). Thegroup's investments during the reporting period amounted to EUR 426thousand (EUR 110 thousand in 2008).PersonnelDuring the reporting period January - September 2009, the company'spersonnel was on average 81(35 during January - September, 2008) andat the end of the reporting period 83 (34 on September 30, 2008). Theincrease is due to the inclusion of the German subsidiary, which wasacquired in November 2008.Extraordinary General MeetingOn September 28, the Board of Directors resolved to call anExtraordinary General Meeting of shareholders to be held on October29, 2009. It proposes to elect Dr. Peter Fellner as new member of theBoard of Directors. Furthermore, it proposes to authorize the Boardof Directors to resolve on one or more issues which contains theright to issue new shares or dispose of the shares in the possessionof the company and to issue options or other specific rights to theshares pursuant to chapter 10 of the Companies Act. The authorisationwould consist of up to 72,000,000 shares in the aggregate and wouldsupersede earlier authorizations. The authorisation is proposed to beused for material arrangements from the company's point of view, suchas financing or implementing business arrangements or investments orfor other such purposes determined by the Board of Directors in whichcase a weighty financial reason for issuing shares, options or otherspecific rights and possibly directing a share issue would exist. Theauthorisation could not, however, be used to create new share-basedincentive schemes. Due to the recent amendment to the FinnishCompanies Act, the Board also proposes to amend the articles ofassociation accordingly.Group structureThe parent company of the group is Biotie Therapies Corp. Thedomicile of the Company is Turku, Finland. The group has an operativesubsidiary, Biotie Therapies GmbH, located in Radebeul, Germany.During Q3 2009, Biotie Therapies GmbH has wound down its formernon-operating subsidiary, 4AZA IP NV of Leuven, Belgium. 4AZA IP wasa special purpose vehicle whose sole activity was the holding ofcertain intellectual property rights, which the Company decided toabandon.The parent company also has a non-operational subsidiary named BiotieTherapies International Ltd in Finland and an associated company withno activities, Contral USA which is domiciled in Delaware, USA.Share capital and SharesBiotie's shares are quoted on the NASDAQ OMX Helsinki Ltd (Small cap,Healthcare). Biotie Therapies has 144,320,560 shares outstanding andthe share capital amounts to EUR 44,290,678.10 (under FinnishAccounting Standards, FAS). All the company's shares are of the sameseries and have equal rights. All the shares are freely transferableand contain one voting right each.The company has in its possession 819.000 of its own shares. Thecompany has a stock lending agreement with EVLI Bank in place inrelation to the company's option programs. Pursuant to thisagreement, the number of the company's own shares in its possessionmay be temporarily less than 819,000.At the end of September the share price was EUR 0.58, the highestprice during January - September was EUR 0.67, the lowest was EUR0.23, and the average price was EUR 0.38. Biotie's marketcapitalization at the end of September was EUR 83.7 million.The trading volume on NASDAQ OMX Helsinki during the reporting periodJanuary - September was 29,903,949 shares, corresponding to aturnover of EUR 10.89 million.LP market making agreement with NordeaBiotie and Nordea Bank Finland Plc concluded a market makingagreement, which fulfils the requirements of NASDAQ OMX HelsinkiLtd's Liquidity Providing (LP) operations. The market makingagreement aims at increasing the share's liquidity and decreasing theshare price volatility thus facilitating trading.According to the agreement, Nordea will provide Biotie's share withbids and offers so that the maximum spread is 4% calculated from thebid quotation. Bids or offers include at least 4,000 shares and thevalue of the shares must correspond to at least 4,000 euros.Nordea undertakes to submit bids and offers for Biotie's share on theofficial list in the trading system of NASDAQ OMX Helsinki on eachtrading day for at least 85 per cent of the time of continuoustrading, at the opening and closing call of the trading day and inthe auction procedures applicable to the share during a trading day.The market making in accordance with the agreement began on September24, 2009. After a 6-month term, the market making agreement is validuntil further notice. The term of notice of the agreement is onemonth.Changes in ownershipBiotie has on February and July, 2009 gained knowledge of thenotifications regarding the following changes in holdings inaccordance with Chapter 2, Section 9 of the Finnish SecuritiesMarkets ActInformation on notices of change in ownership are available on thecompany's website at www.biotie.com/investors.Short-term risks and uncertaintiesBiotie's strategic risks are predominantly related to the technicalsuccess of the drug development programs, regulatory issues, thestrategic decisions of its commercial partners, ability to obtain andmaintain intellectual property rights for its products, validity ofits patents, launch of competitive products and the development ofthe sales of its products and availability of funds to support itsoperations. For example, even though the commercialization andcollaboration agreements on the company's product developmentprojects have been concluded, there can be no assurance that thecontracting partner will act in accordance with the agreement, theauthorities will approve the product under development or theapproved product will be commercialized. The development and successof the company's products depends to a large extent on third parties.Any adverse circumstance in relation to any of its R&D programs mightjeopardize the value of the asset and thus, represent a severe riskto the company. Such adverse events could happen on a short termnotice and are not possible to foresee.The key operational risks of Biotie's activities include thedependency on key personnel, assets (especially assets in relation tointellectual property rights) and dependency on its license partners'decisions.Significant financial resources are required to advance the drugdevelopment programs into commercialized pharmaceutical products. Tofund the operations, the group relies on its ability to securefinancing from four major sources: income from its license partners,grant income, loans from TEKES and raising equity financing in thecapital markets.Entering into commercialization, collaboration and licensingagreements with larger pharmaceutical companies entitles the Companyand its subsidiaries to receive up-front, milestone dependent androyalty payments from these partners. Although Biotie has currentlyseveral active license agreements in place, any decision by one ofits partners to terminate an agreement would have a negative effecton the short to medium term access to liquidity of the Company.In addition, the Company relies on different sources of research anddevelopment grants and loans. These funds, which are provided throughregional, national or EU level institutions with the aim of fosteringeconomic and technological progress in the region in which the groupoperates, have been historically available to Biotie at substantiallevels. Availability of such funds in the mid- to long term futurecannot be guaranteed and thus this poses a potential risk to theincome situation of the group in the future. Income and loans fromsuch sources have been secured until 2009. So far, the Company has noindication that this source of financing will be available beyond2009.Furthermore, the Company relies on capital market to raise equity anddebt financing from time to time. There can be no assurance thatsufficient financing can be secured in order to permit the Company tocarry out its planned activities. Current capital market conditionsare volatile and it is currently uncertain whether the Company cansecure equity financing if and when it needs it from capital markets.To protect the continuity of Biotie's operations, sufficientliquidity and capital has to be maintained in the Company and itssubsidiaries. The group aims to have cash funds to finance at leastone year's operations at all times. The group can influence theamount of capital by adapting its cost basis according to thefinancing available. Management monitors the capital and liquidity onthe basis of the amount of equity and cash funds. These are reportedto the Board on a monthly basis.Events after the reporting periodThe Company has entered into a Standby Equity Distribution Agreementwith YA Global Master SPV Ltd. ("YA Global") a fund managed byYorkville Advisors, LLC of Jersey City, New Jersey, USA("Yorkville"). Under the terms of the agreement, Biotie has theoption, at the sole and exclusive discretion of the Company, to takeup YA Global's commitment to subscribe and pay for ordinary no-parBiotie shares up to a total value of 20 million euro over a period of36 months.At any time during the 36 month commitment period, Biotie may requireYA Global to purchase newly issued Biotie shares or shares Biotie hasin its own possession by delivering an advance notice to YA Globaldesignating requested portion of the commitment amount to be takenup. The maximum portion of the commitment amount to be used at a timeis 50,000 euro for the first tranche, 100,000 euro for the secondtranche and 300,000 euro for the subsequent tranches. The number ofshares issuable to YA Global shall, however, in no event cause theaggregate number of shares beneficially owned by YA Global and itsaffiliates to exceed 4.99% of the then issued shares. Further, in noevent shall the aggregate number of shares issued by Biotie to YAGlobal exceed 9.9% of all outstanding shares of Biotie during arolling twelve month period unless Biotie ensures that all sharesissued despite exceeding the threshold are or will be admitted forlisting.The pricing of the shares will be determined as 95% of the lowestdaily volume-weighted average share price of the five trading daysfollowing the date on which Biotie shall have sent to YA Global therelevant advance notice, and may in no event be less than 85% of thedaily volume-weighted average price of Biotie shares on NASDAQ OMXHelsinki Ltd. on the last trading day prior to such date of advancenotice ("Minimum Price"). Further, should the market price on certainof the five trading days following the date of advance notice fallbelow the Minimum Price, the pro rata subscription for such days willnot be executed unless YA Global decides to execute such subscriptionat the Minimum Price.The purpose of the Standby Equity Distribution Agreement is to securethe financing of Biotie's working capital in the short and mediumterm. In consideration of the committed standby equity Biotie willpay to YA Global a one-time commitment fee of 200.000 euro, payablein Biotie shares, as well as a structuring fee and a due diligencefee.Future outlook- During 2009, Biotie will provide support to its license partnerLundbeck for the ongoing phase III studies with Nalmefene in alcoholdependence.- Biotie will continue to perform two clinical studies with itsproprietary VAP-1 antibody in psoriasis and rheumatoid arthritispatients in the course of 2009. Results of these studies will becomeavailable in the first half of 2010.- The company will continue to conduct a clinical trial for itsproprietary, small molecule PDE-4 inhibitor ELB353 with the aim toobtain proof of pharmacodynamic activity in humans, corroborate thesafety profile and establish dose ranges for further therapeuticstudies.- In its collaboration with Wyeth on the discovery and development ofnovel PDE10 inhibitors for the treatment of psychiatric disorders,Biotie and its partner intend to identify further developmentcandidates.- Due to the increased clinical trial activity it is foreseeable thatthe company's R&D expenses (excluding the extraordinary impairmentcosts) will increase in comparison to previous financial year. At thesame time, income will also be higher due to the additional incomegenerated through the company's newly acquired subsidiary. Overall,negative cash flow from operational activities is expected tomoderately increase in comparison to previous financial year.Next financial reportBiotie's financial statement release 2009 will be published onFebruary 26, 2010.IFRS and Accounting principlesThe 2009 interim report has been prepared in accordance with IFRSrecognition and measurement principles, and applying the sameaccounting policy as for the 2008 financial statements. In addition,the changes in the presentation of statement of comprehensive incomeand the statement of changes in equity according to the revised IAS 1have been applied in the interim report. The IFRS 8 'operatingsegments' standard does not have an impact on the presentation of theGroup's financial statements since the Group is operating as onesegment. The interim report has not been prepared in accordance withIAS 34, Interim Financial Reporting.Financial statements for the period from January 1, 2009 to September30, 2009 are not directly comparable to those of the same period in2008 due to the inclusion of the operating result of the wholly ownedsubsidiary Biotie Therapies GmbH (formerly elbion GmbH) in 2009.This interim report is unaudited.In Turku, October 23, 2009Biotie Therapies Corp.Board of DirectorsFor further information, please contact:Virve Nurmi, Investor Relations Managertel. +358 2 274 8900, e-mail: virve.nurmi(at)biotie.comDistribution:NASDAQ OMX Helsinki LtdMain Mediawww.biotie.comCONSOLIDATED 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 31.12.2008EUR 3 months 3 months 9 months 9 months 12 months1,000Revenue 1,792 791 4,532 3,950 5,127Research and -3,828 -1,076 -16,741 -6,276 -8,730developmentexpensesGeneral and -804 -302 -2,703 -1,201 -2,020administrativeexpensesOther operating 443 59 1,203 179 502incomeOther operating -29 -41 0expenseOperating -2,426 -528 -13,750 -3,348 -5,121profit/lossFinancial income 125 273 571 508 1,432Financial expenses -215 -245 -759 -962 -1,864Profit/loss before -2,516 -500 -13,938 -3,802 -5,553taxesTaxes 0 0 1,859 0 76Net income/loss -2,516 -500 -12,079 -3,802 -5,477Total -2,516 -500 -12,079 -3,802 -5,477comprehensiveincome of theperiodNet income/lossattributable to Parent company -2,516 -500 -12,079 -3,802 -5,477shareholdersTotalcomprehensiveincomeattributable to: Parent company -2,516 -500 -12,079 -3,802 -5,477shareholdersEarnings per share -0.02 -0.01 -0.08 -0.04 -0.06(EPS)basic & diluted,EURCONSOLIDATED STATEMENT OF FINANCIAL POSITION(IFRS)EUR 1,000 30.9.2009 30.9.2008 31.12.2008AssetsNon-current assetsIntangible assets 7,194 707 10,352Goodwill 379 0 379Property, plant and equipment 2,782 350 2,792Other shares 10 0 0 10,365 1,057 13,523Current assetsPrepaid expenses 0 0 2,400Available for sale investment 131 0 131Investments held to maturity 6,000 18,300 18,500Accounts receivables and other 1,642 1,181 1,512receivablesFinancial assets at fair value 3,028 0 0throughprofit or lossCash and cash equivalents 7,673 2,667 6,738 18,474 22,148 29,281Total 28,839 23,205 42,804Equity and liabilitiesShareholders' equityShare capital 36,361 19,779 36,361Reserve for invested unrestricted 980 980 980equityRetained earnings -37,073 -31,808 -31,754Net income/loss -12,079 -3,802 -5,477Shareholders' equity total -11,811 -14,852 110Non-current liabilitiesProvisions 143 0 121Non-current financial liabilities 25,431 24,472 24,930Pension benefit obligation 593 0 574Other non-current liabilities 6,544 5,602 5,881Non-current deferred revenues 1,849 3,035 2,966Deferred tax liabilities 0 1,859 34,560 33,109 36,331Current liabilitiesProvisions 607 18 641Pension benefit obligation 17 0 10Current financial liabilities 209 143 144Current deferred revenues 2,140 1,175 3,501Accounts payable and other current 3,117 3,612 2,067liabilities 6,090 4,948 6,363Liabilities total 40,650 38,057 42,694Total 28,839 23,205 42,804CONSOLIDATED STATEMENT OF CHANGES IN SHAREHOLDERS' EQUITYAttributable to equity holders of the parent companyEUR 1,000 Shares Share Reserve Own Retained Share- (1000 Capital For Shares Earnings holders' pcs) invested equity Un- total restricted equityBalance at 90,212 19,850 980 -15 -31,930 -11,1171.1.2008Total -3,802 -3,802comprehensiveincome for theperiodOptions granted 138 138Cost of share -71 -71issue 0 -71 0 0 -3,664 -3,735BALANCE AT 90,212 19,779 980 -15 -35,594 -14,85230.9.2008Total -1,675 -1,675comprehensiveincome for theperiodOptions granted 55 55Share issue 54,109 16,873 16,873Cost of share -291 -291issue 54,109 16,582 0 0 -1,620 14,962BALANCE AT 144,321 36,361 980 -15 -37,215 11031.12.2008Total -12,079 -12,079comprehensiveincome for theperiodOptions granted 158 158 0 0 0 0 -11,921 -11,921BALANCE AT 144,321 36,361 980 -15 -49,136 -11,81130.9.2009CONSOLIDATED STATEMENT OF CASH FLOWS 1.1.- 1.1.- 1.1.- 30.9.2009 30.9.2008 31.12.2008EUR 1,000 9 months 9 months 12 monthsCash flow from operating ActivitiesNet income/loss -12,079 -3,802 -5,477Adjustments: 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 -76Change 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 -152Interests paid -107 -5 -29Interests received 430 39 66Taxes paid -5 0 0Net cash from operating activities -8,757 -7,867 -9,370Cash flow from investing activitiesAcquisition of subsidiary, net of cash 0 0 1,881acquiredChange in financial assets atfair value through profit or loss Additions -3,000 0 0 Disposals 0 27,685 27,685Change in investments held to maturity Additions -900 -21,800 -46,300 Disposals 13,400 3,598 28,321Investments to tangible assets -116 -28 -34Net cash used in investing activities 9,384 9,456 11,553Cash flow from financing activitiesPayments from share issue 0 0 3,300Share issue costs 0 -71 -362Proceeds from borrowings 421 888 1,374Repayment of loans -40 -40 -40Repayment of lease -72 -4 -21CommitmentsNet cash from financing activities 309 774 4,250Net increase (+) or decrease (-) 936 2,362 6,433in cash and cash equivalentsCash and cash equivalents in the 6,738 305 305beginning of the periodCash and cash equivalents in the 7,673 2,667 6,738end of the periodContingent liabilitiesEUR 30.9.2009 30.9.2008 31.12.20081,000Operating lease 124 146commitments 123Due within a year 81 69 64Due later 43 77 59Rent commitments 415 570 532Due within a year 233 233 233Due later 182 337 299Total 539 716 655The Group leases motor vehicles, machines and equipment with leasesof 3 to 5 years.Rent commitments include Pharmacity premises until 30 November 2011.These premises have been subleased.CommitmentsOn September 30, 2009 Biotie had purchase commitments, primarily forcontract research work services, totaling EUR 7.3 million.KEY FIGURES 1.1.- 1.1.- 1.1.- 30.9.2009 30.9.2008 31.12.2008EUR 1,000 9 months 9 months 12 monthsBusinessdevelopmentRevenues 4,532 3,950 5,127Personnel on average 81 35 42Personnel at the end of period 83 34 80Research and development costs 16,741 6,276 8,730Capital expenditure 426 110 116ProfitabilityOperating profit/loss -13,750 -3,348 -5,121 as percentage of revenues, % -303.4 -84.8 -99.9Profit/loss before taxes -13,938 -3,802 -5,553 as percentage of revenues, % -307.5 -96.3 -108.3Balance sheetCash and cash equivalents 16,701 20,967 25,238Shareholders equity -11,811 -14,852 110Balance sheet total 28,839 23,205 42,804Financial ratiosReturn on equity, % - - -Return on capital employed, % -71.9 -33.9 -18.3Equity ratio, % -41.0 -64.0 0.3Gearing, % -75.7 -24.6 -148.5Per share dataEarnings per share (EPS) basic & -0.08 -0.04 -0.06diluted, EURShareholders'equity per share, EUR -0.08 -0.17 0.0008Dividend per share, EURPay-out ratio, %Effective dividend yield, %P/E-ratioShare 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 0.26Market capitalization 83.7 43.3 37.5at the end of period MEURTrading of shares Number of shares traded 29,903,949 8,542,915 15,350,613 As percentage of all 20.7 9.5 10.6Adjusted weighted average 144,320,560 90,211,860 96,734,553number of shares during the periodAdjusted number of shares 144,320,560 90,211,860 144,320,560 at the end of the periodFormulas for the Calculation of the Key figuresReturn on capital employed, %Profit (loss) before taxes + interest expenses and other financialexpenses--------------------------------------------------------------- x 100Balance sheet total - non-interest bearing liabilitiesEquity ratio, %Shareholders' equity--------------------------------------------------------------- x 100Balance sheet total - advanced receivedGearing, %Interest bearing liabilities - cash and cash equivalents-------------------------------------------------------------- x 100Shareholders' equityEarnings per share (EPS)Profit attributable to parent company shareholders------------------------------------------------------------------Adjusted average number of outstanding shares during the periodShareholders' equity per shareShareholders' equity------------------------------------------------------------------Adjusted number of shares at the end of the periodhttp://hugin.info/132030/R/1349665/325334.pdfThis announcement was originally distributed by Hugin. The issuer is solely responsible for the content of this announcement.
Datum: 23.10.2009 - 07:31 Uhr
Sprache: Deutsch
News-ID 7315
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"Biotie Therapies Corp. interim report January 1 - September 30, 2009"
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