Biotie Therapies Oyj. Varsinainen yhtiökokous Turku,

Transkriptio

1 Biotie Therapies Oyj Varsinainen yhtiökokous Turku,

2 Biotie Therapies Corp. Annual General Meeting Turku, Timo Veromaa President and CEO

3 Biotie in brief focused on growth potential Headquartered in Turku, Finland with operations in Radebeul, Germany Discovery and development pipeline focused on novel therapeutics for central nervous system disorders (addiction, psychotic disorders) and inflammatory diseases (rheumatoid arthritis, psoriasis and COPD) Turku, Finland Collaboration agreements with top-tier pharmaceutical companies Listed on NASDAQ OMX Helsinki Ltd since 2002 (Ticker symbol: BTH1V) Radebeul, Germany 3

4 Balanced CNS and inflammation product pipeline 4

5 CNS pipeline

6 Nalmefene Novel Treatment for Alcohol Dependence New treatment paradigm Oral tablet once daily taken as needed to reduce heavy drinking Efficacy, safety and treatment regimen established in phase III studies Amenable to use both in primary care and specialist settings Considerable sales potential Substantial unmet medical need 50 million alcohol misusers in key markets Potential to rapidly expand an already growing market Lundbeck the ideal partner Leveraging Lundbeck s specialist psychiatry sales force Agreement headline value: EUR 84 million plus royalties Clear plan for reaching market Lundbeck is conducting further phase III studies in 1,800 patients in addition to spearheading centralised approval procedure in the EU Top-line data and European MAA anticipated in

7 Nalmefene ongoing phase III program design Lundbeck started 1800 patient phase III program December efficacy studies Esense1 (N=600, 6 month efficacy, Northern Europe) Esense2 (N=600, 6 month efficacy, Southern Europe) 1 long-term safety study Sense (N=667, 12 month safety, UK, Eastern EU, Russia, Ukraine) Endpoints: monthly number of heavy drinking days and monthly total consumption Topline data and EU MAA submission for centralised approval in

8 PDE10 Inhibitors: new treatment paradigm for schizophrenia Indication and novel mechanism of action Intellectual property Improved tolerability Significant market potential Current status Schizophrenia and bipolar disorder Selective inhibitor of phosphodiesterase 10 (PDE10) In-house discovery and innovation New small molecule inhibitors of PDE10 developed in-house Compounds patent protected until at least 2026 Similar efficacy but improved side effect profile in animal models compared to current treatments High unmet medical need 3 billion market potential Ongoing R&D collaboration with Wyeth US$110m across upfront, milestones, and research funding, US$12 received so far Significant royalties on future product sales Currently in pre-clinical development. Clinical candidates to be identified in

9 Anti-inflammatory therapeutic product pipeline

10 ELB353 Differentiated PDE4 Inhibitor for COPD Validated mechanism of action Potent and selective small molecule inhibitor of phosphodiesterase 4 (PDE4) Long half life and active metabolite Convenient administration Once daily oral dosing Dose-dependent exposure proven in clinical trial Significant market potential Currently no treatment preventing progression of the disease US$4.6 billion market and expanding Improved tolerability Improved side-effect profile vs. other PDE4 inhibitors especially with respect to GI and CNS related side effects Good tolerability and dose-dependent exposure proven in clinical trial 10

11 VAP-1 antibody highly valued biologic in phase I Biotie s proprietary target Mode-of-action independent of TNF alpha pathway Extensive IP, both on the VAP-1 target and on the product State-of-the-art fully human antibody Two clinical studies ongoing Significant sales potential Roche as key partner Antibody based on Medarex Humab technology Convincing preclinical package and supporting clinical evidence First phase I study (single dose) successful, two clinical studies in RA and psoriasis patients ongoing since 02/2009 and 03/2009 Results expected in H1/2010 Fast growing inflammation market with peak sales potential up to EUR 1.5 billion in the EU Roche paid EUR 5 million for option to license the product First opt-in point after completion of currently ongoing clinical trials Licensing agreement with Seikagaku for Asian territory in place 11

12 The year 2008 in brief - In January Lundbeck acquired the United Kingdom and Ireland rights for Nalmefene from Britannia Pharmaceuticals. - In June Biotie announced top-line data from the first-in-man clinical study with its fully human VAP- 1 monoclonal antibody. - In September top-line data were released of the clinical trial with Nalmefene evaluating potential cardiac effects. - In November Biotie acquired the pharmaceutical discovery and development company elbion GmbH (now Biotie Therapies GmbH). - In December Lundbeck initiated three phase III clinical trials with Nalmefene for the treatment of alcohol dependence. 12

13 Events after 31. December, In February and March 2009, Biotie started two clinical studies in rheumatoid arthritis and psoriasis patients with its fully human VAP-1 monoclonal antibody. -In March 2009, Lundbeck acquired the North-American and Mexican rights for Nalmefene from Somaxon Pharmaceuticals. - In April 2009 Biotie's board resolved to issue option rights to certain employees of the company. The resolution of the Board of Directors is based on the resolution of the company's Extraordinary General Meeting of 14 November. - In April 2009, Lundbeck acquired the Turkish marketing and distribution rights for Nalmefene from Eczacibasi Ilac Pazarlama A.S. and now has worldwide rights, excluding South-Korea 13

14 Financial and corporate information

15 Financial highlights FY 2008 (audited) and Q (unaudited) In EUR m (except per share information) Q1/2009 Q1/ Revenues other operating income Research and development expenses Net loss Loss per share 0,02 0,02 0,06 0,02 Cash and cash equivalents Cash flow from operations Total assets

16 Shareholder structure Total number of shares issued million (143.5 m outstanding) Fully diluted number of shares million 16

17 Development of Turnover and Share Price January 1 December 31, 2008 OMX Helsinki index Biotie 17

18 Development of turnover and share price in 2009 Biotie (+21.6%) 20 day moving average OMX Helsinki index (+7.7%) 18

19 Balanced CNS and inflammation product pipeline 19

20 Future outlook Support to license partner Lundbeck for the ongoing phase III studies with Nalmefene in alcohol dependence Two clinical studies with VAP-1 antibody in psoriasis and rheumatoid arthritis patients ongoing. Results expected first half of 2010 Initiation of clinical trial for 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 Discovery and development of novel PDE10 inhibitors for the treatment of psychiatric disorders in its collaboration with Wyeth. Biotie and Wyeth intend to identify development candidates in 2009 Completion of the integration of operations of the recently acquired German subsidiary Biotie Therapies GmbH Embrace business and finance opportunities in

21 Potential measures relating to the decrease of equity

22 Financial Situation of the Parent Company as of December 31, 2008 Shareholders Equity: Share capital: EUR 14.5 million EUR 44.3 million Shareholders equity is less than one half of the share capital, but: Capital loans: EUR 21.3 million Shareholders equity and capital loans EUR 35.8 million Liquid funds: EUR 22.9 million (FAS) 22

23 Potential Measures No immediate measures required 23

24 Resolving on the remuneration of the members of the Board of Directors Hallituksen jäsenten palkkioista päättäminen The Board of Directors proposes on the basis of the recommendation of the Nomination and Remuneration Committee that the remuneration payable to the members of the Board of Directors should be as follows: EUR 3,000 per month for the Chairman and each member residing abroad and EUR 1,500 per month for each member residing in Finland. In addition, it is proposed that reasonable travelling expenses for the meetings would be compensated. Hallitus ehdottaa nimitys- ja palkitsemisvaliokunnan ehdotuksen mukaisesti, että hallituksen jäsenille maksettaisiin palkkiota seuraavasti: hallituksen puheenjohtajalle ja ulkomailla asuville jäsenille euroa kuukaudessa ja hallituksen muille jäsenille euroa kuukaudessa. Lisäksi ehdotetaan korvattavaksi kohtuulliset matkakulut kokouksiin. 24

25 Election of members of the Board of Directors Hallituksen jäsenten valitseminen The Board of Directors proposes on the basis of the recommendation of the Nomination and Remuneration Committee that the number of members of the Board of Directors would be seven (7). The Board of Directors proposes on the basis of the recommendation of the Nomination and Remuneration Committee that Juha Jouhki, Ann Hanham, Bernd Kastler, Pauli Marttila, Riku Rautsola, Christoph Schröder and Pierre Serrure would be elected as members of the Board of directors for the term expiring at the end of the following annual general meeting. Hallitus ehdottaa nimitys- ja palkitsemisvaliokunnan ehdotuksen mukaisesti, että yhtiön hallituksen jäsenten lukumäärä olisi seitsemän (7). Hallitus ehdottaa nimitys- ja palkitsemisvaliokunnan ehdotuksen mukaisesti, että hallituksen jäseniksi valittaisiin Juha Jouhki, Ann Hanham, Bernd Kastler, Pauli Marttila, Riku Rautsola, Christoph Schröder ja Pierre Serrure toimikaudeksi, joka päättyy seuraavan varsinaisen yhtiökokouksen päättyessä. 25

26 Authorizing the Board of Directors to decide on the issuance of shares as well as the issuance of options and other special rights entitling to shares The Board of Directors proposes that the Annual General Meeting would authorise 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 25,000,000 shares in the aggregate. A maximum of 819,000 own shares in the possession of the company could be conveyed. The authorisation would not exclude the Board of Directors right to decide on a directed issue. 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. Further, the authorisation could be used to create new share-based incentive schemes. The Board of Directors would be authorised to resolve on all other terms and conditions of a share issue, options and other specific share entitlements as referred to in chapter 10 of the Companies Act, including the payment period, determination grounds for the subscription price and subscription price or allocation of shares, option rights or specific rights free of charge or that the subscription price may be paid besides in cash also by other assets either partially or entirely. The authorisation would be effective until 30 June The Board of Directors proposes that the authorisation shall not supersede earlier authorisations. 26

27 Hallituksen valtuuttaminen päättämään osakeannista sekä optiooikeuksien ja muiden osakkeisiin oikeuttavien erityisten oikeuksien antamisesta Hallitus ehdottaa, että yhtiökokous valtuuttaisi hallituksen päättämään yhdestä tai useammasta annista, joka sisältää oikeuden antaa uusia tai luovuttaa yhtiön hallussa olevia osakkeita, sekä antamaan optioita tai muita osakeyhtiölain 10 luvun mukaisia erityisiä oikeuksia osakkeisiin. Valtuutus käsittäisi yhteensä enintään osaketta. Yhtiön hallussa olevia omia osakkeita voitaisiin luovuttaa enintään kappaletta. Valtuutuksessa ei suljettaisi pois hallituksen oikeutta päättää suunnatusta annista. Valtuutusta esitetään käytettäväksi yhtiön kannalta tärkeiden järjestelyjen kuten liiketoimintaan liittyvien järjestelyjen tai investointien rahoittamiseen tai toteuttamiseen tai sellaisiin muihin hallituksen päättämiin tarkoituksiin, joissa osakkeiden, optioiden tai muiden osakkeisiin oikeuttavien erityisten oikeuksien antamiseen ja mahdolliseen annin suuntaamiseen on painava taloudellinen syy. Valtuutusta voitaisiin käyttää myös uusien osakepohjaisten kannustinjärjestelmien luomiseen. Yhtiön hallitus olisi valtuutettu päättämään kaikista muista osakeannin, optioiden sekä muiden osakeyhtiölain 10 luvun mukaisten erityisten oikeuksien antamisen ehdoista, mukaan lukien maksuajasta, merkintähinnan määrittelyperusteista ja merkintähinnasta tai osakkeiden, optio-oikeuksien tai erityisten oikeuksien antamisesta maksutta tai siitä, että merkintähinta voidaan maksaa paitsi rahalla myös kokonaan tai osittain muulla omaisuudella. Valtuutus olisi voimassa saakka. Valtuutus ei kumoaisi aikaisempia valtuutuksia. 27