Biotie Therapies Update: SYN120 rights retained

Assets available for partnering Pharma & biotech

Biotie’s retention of SYN120 rights after Roche decided not to opt-in to a 6 July 2012 development license means the company now has three unencumbered Phase II- Price €0.37 ready assets available for global licensing. A deal on any of these could extend Market cap €143m Biotie’s current cash runway beyond early 2013, although the company may explore other options as additional funds will likely need to be raised this year. The next key catalyst with known timing is the European approval decision for dependence Shares in issue 387.6m therapy Selincro, expected by year-end. Approval could mean a Q113 launch, which Free float N/A would trigger an undisclosed milestone payment from partner . Code BTH1V

Primary exchange OMX Year end Revenue PBT* EPS* DPS P/E Yield Other exchanges N/A (€m) (€m) (c) (c) (x) (%) 12/10** 2.0 (8.5) (5.2) 0.0 N/A N/A Share price performance 12/11 1.0 (20.8) (3.5) 0.0 N/A N/A 12/12e 0.1 (28.0) (6.7) 0.0 N/A N/A 12/13e 0.1 (29.6) (7.5) 0.0 N/A N/A Note: *PBT and EPS are normalised, excluding intangible amortisation and exceptional items. ** Represents ‘continuing operations’. Forecasts do not assume further deal activity.

SYN120: Rights returned for strategic portfolio reasons Various large pharma/CNS specialists are investigating 5-HT antagonists, which have 6 potential in cognitive impairment; Lundbeck has recently achieved proof of concept in % 1m 3m 12m Alzheimer’s disease. SYN120 is safe/well tolerated, has a wide therapeutic window Abs 12.1 (19.6) (31.5) and confirmed dosing for Phase II. Biotie has been approached by interested parties, Rel (local) 3.2 (10.3) (10.9) although deal timing is uncertain. Other Phase II-ready assets available for partnering 52-week high/low €0.6 €0.3 include BTT-1023 (H2 start of clinical studies in fibrotic disorders) and ronomilast. Business description Licensed programmes: Selincro and tozadenant Biotie Therapies is a Finnish/US biotech company with a focus on clinical Commercial success of the two partnered projects has potential to transform Biotie. programmes in CNS and niche The EMA approval decision for Selincro (alcohol dependence) by end-2012 should inflammatory diseases. Its lead project catalyse the share price; potential Q113 launch would trigger a Lundbeck milestone. Selincro, for the treatment of alcohol The next news flow for UCB-partnered tozadenant is the read-out of the Phase IIb trial dependency, is partnered with Lundbeck and pending EU approval. UCB is a in Parkinson’s disease (which recently completed enrolment) around end-2012. strategic partner.

Financials: Cash into 2013 with potential for deals Next events Q1 cash of €25m represents funds into 2013 in the absence of additional receipts. Q212 results 3 August SYN117: PTSD Phase II data H212 Upfront payments on new licensing deals, milestones from existing partners Selincro: EMA approval H212 (Lundbeck on Selincro EU launch, UCB on tozadenant Phase IIb data/Phase III start), Tozadenant: Phase IIb results End-2012 and/or an equity raise in 2012 could address Biotie’s funding requirement. Selincro: Europe launch H113

Valuation: €243m rNPV, current EV of €115m Analysts Our new rNPV of €243m (previously €250m) reflects BTT-1023’s re-positioning as a Lala Gregorek +44(0)20 3077 5736 potential fibrotic disease therapy. This valuation only includes the lead indications of Robin Davison +44(0)20 3077 5737

[email protected] Biotie’s five core assets and compares with a €115m EV (excluding the Tekes financial

Edison profile page liability, which is only repayable on profitability). Significant potential milestones from Lundbeck and UCB are not captured in this valuation, and thus represent upside.

Biotie Therapies is a research client of Edison Investment Research Limited

Biotie Therapies | 6 July 2012

Biotie Therapies: Data sheet

Exhibit 1: Biotie Therapies’ R&D pipeline

Product Indication/stage Partners/financial terms/notes Selincro Alcohol dependence Global deal with Lundbeck provides up to €84m in upfront and milestone payments (€12m received (nalmefene) (Phase III)/ to date) and tiered double-digit royalties. Phase III programme (20mg nalmefene on demand), pathological conducted by Lundbeck complete with positive top-line results: Selincro was effective in reducing gambling/smoking alcohol intake (less frequent heavy drinking and lower overall alcohol consumption) by >66% over six cessation months. Two 24-wk placebo-controlled Phase III studies: ESENSE1 (598-pts) and ESENSE2 (718- pts) (primary efficacy endpoints: change in baseline in the monthly number of heavy drinking days and total alcohol consumption) and SENSE (a 665-pt, 52-week safety study). Detailed Phase III data presented (by Lundbeck) at the European Congress of Psychiatry, Prague (3-6 March) and the Annual Research Society on (RSA) Meeting, San Francisco (23-27June). EU MAA filed and accepted (Dec 2011), potential approval late 2012, with first launches (triggering a milestone) expected from early 2013. Oral opioid receptor antagonist drug to be taken on an ‘as needed’ basis. Tozadenant/ Parkinson’s disease Partnered with UCB globally: deal included $20m equity investment with up to $370m in regulatory SYN115 (Phase II) and commercial milestones plus double-digit tiered sales royalties (with potential for collaboration expansion). UCB responsible for post-Phase IIb development and marketing. Oral: PK consistent with once-daily dosing. Well tolerated up to 480mg/day for up to 28 days. 400-pt double-blind Phase IIb (80-pts/arm: four doses and placebo) fully enrolled: primary endpoint of improvement in motor function (UPDRS OFF time) at 12 wks with non-motor secondary endpoints (results: end-2012). 30- pt Phase IIa showed dose-dependent functional activity in brain regions associated with motor function/cognition (clinical improvement in both). Activity in preclinical models of depression, cognition and anxiety. Potential neuro-protective drug. Licensed from Roche. Selective A2a antagonist. SYN120 Cognitive disorders Once-daily oral small molecule drug: can cross the BBB; no QTc (cardiovascular) side effects. Phase I associated with single and multiple ascending dose studies in 70 healthy volunteers complete (studied for up to 14 Alzheimer’s disease/ days at doses up to 600mg/day, which >10x the anticipated therapeutic dose. Wide therapeutic schizophrenia window: PET study in nine healthy volunteers established that target levels of receptor occupancy (Phase II ready) expected for efficacy could be achieved with doses an order of magnitude lower than those shown to be safe/well tolerated. Phase II enabling package complete: appropriate dosing established. Licensed from Roche, which declined to exercise one-time option to global rights. Seeking development partner. Back-up SYN-114 has completed Phase I. Oral 5HT6 receptor antagonist. BTT-1023 Fibrotic diseases Phase II-ready: manufacturing process and scale up optimisation underway. Phase II trials in select (Phase II ready) indications to start H212. Previous studies in inflammatory indications but development strategy now rheumatoid focused on fibrosis disease indications. Repeat-dose Phase I studies in 24 RA pts showed PK arthritis/ consistent with chronic use and some evidence of efficacy at higher doses (ACR50 response in (Phase I complete) several higher dose patients). Results of similar ascending multiple dose study in psoriasis showed consistent tolerability and PK, and evidence of efficacy (decrease in PASI score). New opportunity in liver inflammatory fibrotic diseases identified (patent pending). Biotie holds global rights after Asia- Pacific license with Seikagaku terminated for strategic reasons ($2.7m received under this deal). Deal discussions ongoing for large indications. Fully human monoclonal targeting VAP-1. Nepicastat/ Drug dependence / 120-pt Phase II in PTSD (results: H212), funded by US Dept of Defense. 180-pt three-month Phase II SYN117 post traumatic stress cocaine dependency study to start H212; funded under a CRADA with the US NIDA. Positive 16-pt disorder (Phase II) Phase IIa study in non-treatment seeking cocaine addicts (safe, well tolerated and reduced subjective responses to cocaine). Oral dopamine β-hydroxylase inhibitor. Ronomilast COPD/asthma/ Phase II-ready. No investment in further clinical development without a partner: active deal psoriasis discussions ongoing. Repeat dose PK studies in 48 healthy volunteers up to 100mg daily showed (Phase II-ready) ronomilast was well tolerated with no serious or severe adverse events, generated highly statistically significant biomarker responses, and had PK supporting a once-daily dose regime. Total of 126-pts studied in Phase I. Once-daily oral PDE4 (phosphodiesterase-4) inhibitor (potential best-in-class: differentiated by improved side-effects [GI/CNS]). Nitisinone/ Movement disorders Fully written down (UCB declined to exercise option to global license for non-orphan indications after SYN118 (Phase II-ready) Phase IIa Parkinson’s disease study missed primary endpoint). Seeking development partner. Oral, once-daily. 21-pt randomised placebo-controlled two-wk proof-of-concept trial in RLS showed symptom improvement (RLS6 and patient diaries). Licensed from Syngenta for non-orphan diseases: marketed by Swedish Orphan Biovitrum for Hereditary Tyrosinemia Type 1 (Orfadin). HPPD inhibitor. Source: Edison Investment Research

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Biotie Therapies | 6 July 2012

Update: Retention of rights opens up prospect of new deal

Biotie is seeking partners for its Phase II-ready third-generation 5HT6 antagonist, SYN120, in development for cognitive disorders, after Roche declined to opt-in to a license for strategic portfolio reasons. Roche opt-in, coupled with an undisclosed payment, would have boosted the company’s current cash balance of c €25m, which provides funding into 2013. However, Biotie remains confident of securing an alternative partner for SYN120 and has already been approached by a number of interested companies. The recent achievement of Phase II proof-of-concept in Alzheimer’s disease

with Lundbeck’s 5-HT6 antagonist, LuAE58054, should stimulate interest. Other unencumbered Phase 1 II-ready assets available for licensing include VAP-1 antibody BTT-10230F for fibrotic disorders and ronomilast for COPD/asthma. Deals on any of these drugs could mitigate Biotie’s funding requirement to some degree, although the company will need to raise additional funds during 2012.

Biotie’s next major catalysts with known timing are the outcome of the EMA approval decision for Selincro (nalmefene) in alcohol dependency and the read-out of the now fully recruited Phase IIb trial of tozadenant in Parkinson’s disease, which are both expected around end-2012. Commercial success of Biotie’s two partnered lead programmes (Selincro and tozadenant) has the potential to transform the company within the next two years should Biotie become eligible for significant milestones coupled to pipeline progress. Selincro approval would enable launch by Lundbeck in Q113, triggering an undisclosed milestone payment to Biotie believed to be in the low double-digit millions. Biotie is eligible to receive up to a total of €72m in regulatory and sales milestones and also royalties on Selincro sales. In addition, total milestones of up to $370m may become due on successful tozadenant development and commercialisation. The magnitude and timing of the next milestone under this deal with strategic partner UCB (which holds an 8% stake in Biotie) is undisclosed; however, the next expected news is the read-out of the Phase IIb Parkinson’s disease trial (timing of data has been brought forward from H113 to end-2012 as recruitment is now complete). At this point, UCB will also take over the responsibility and funding of further tozadenant development. Potential payments from Lundbeck and/or UCB are likely to be received near the end of Biotie’s current cash runway; hence out-licensing of previously mentioned Phase II-ready assets is more critical in the near-term to Biotie’s financial position. Wider business development activities, including the acquisition of late-stage assets (companies or programmes) in neurological disorders, also have the potential to create additional news flow and help Biotie achieve its strategic growth objectives through boosting near-term revenue. Biotie’s focus remains on consolidation in CNS, with the aim of building a sustainable company with a broad pipeline of differentiated products.

Other news flow expected this year includes Phase II data in post-traumatic stress disorder for nepicastat (SYN117) and the start of new clinical studies with nepicastat (cocaine dependence) and VAP-1 antibody BTT-1023 (fibrotic disorders).

SYN120: Available for out-licensing

2 SYN120, a selective third-generation 5-HT6 receptor antagonist1F , is a Phase II-ready development programme for the treatment of Alzheimer’s disease, with potential in other CNS disorders where cognitive impairment is a core feature (eg schizophrenia). It was specifically designed to avoid the cardiovascular (QTc prolongation) issues seen in earlier molecules of this drug class (eg in Epix Pharmaceuticals’ Phase I studies of PRX-07034) and to selectively target the brain. These earlier

1 In April 2012, Biotie and Seikagaku mutually agreed to end their exclusive Asia-Pacific development and commercialisation agreement, on account of the re-profiling of BTT-1023 for fibrotic disorders. Seikagaku’s expertise is in movement disorders; hence the shift in therapeutic focus is no longer strategically aligned. 2 5-HT6 receptors are exclusively located in the brain, primarily in areas associated with cognition, and modulate multiple neurotransmitter systems (including pro-cognitive neurotransmitters such as acetylcholine and glutamate).

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Biotie Therapies | 6 July 2012

safety issues made it imperative that Biotie demonstrated that SYN120 was safe and well tolerated in two Phase I studies. SYN120 has also completed a successful Phase I PET receptor occupancy trial that established the dose for advancement into Phase II trials in cognitive disorders. This trial showed

that target levels of 5HT6 receptor occupancy expected for efficacy could be achieved with doses an order of magnitude lower than those shown to be safe and well tolerated in previous studies, suggesting that SYN120 has a wide therapeutic window and safety margin. Following the conclusion of this trial and a review of the Phase II-enabling package, Roche declined to exercise its opt-in right for strategic portfolio reasons. We believe this is connected to a wider portfolio review as it preceded the announcement that Roche would be closing its one of its research sites in Nutley, New Jersey,

rather than a pronouncement on the potential of SYN120 or the 5-HT6 antagonist drug class.

Other 5-HT6 antagonists are under investigation by large pharma and CNS specialists (Exhibit 2), and Biotie had publicly confirmed that it has been approached by a number of interested parties ahead of PET data/Roche’s opt-in decision. In addition, achievement of Phase II proof of concept by Lundbeck

with its 5-HT6 antagonist, LuAE58054 in Alzheimer’s disease should further stimulate interest for this drug class. Hence, we believe that industry interest in this mechanism of action will continue and that Biotie should be successful in finding a new partner, although deal timing is uncertain.

Exhibit 2: 5-HT6 antagonists in clinical development for Alzheimer’s disease (AD) Drug Company Development stage/notes SB 742457 GlaxoSmithKline Four Phase II trials complete: one dose-ranging and three as adjunctive therapy to donepezil, which showed mixed results (NCT00708552: no difference on primary endpoints vs placebo; NCT00710684 one of two co-primary endpoints met for 35mg dose, no evidence of efficacy for 15mg dose). LuAE58054 Lundbeck Phase II trials complete: 278-pt + donepezil in moderate AD and 124-pt + risperidone in schizophrenia. Proof of concept achieved in AD: statistically significant improvement in cognitive function vs placebo (10mg/day donepezil) over 24-wks as measured by ADAS-cog; positive trends in secondary endpoints. Full data presentation at upcoming medical conferences. Future development strategy in evaluation; intention to start major pivotal programme and seek partners. PF 05212377 Pfizer Four completed Phase I trials: 124-pt single-ascending dose, 56-pt multiple ascending dose, 38-pt (SAM-760) scopolamine challenge and 12-pt PET receptor occupancy trial. Source: Edison Investment Research

Sensitivities

Biotie is subject to sensitivities common to most biotech companies: potential clinical or regulatory failure or delay, commercialisation risks (launch, uptake, pricing, reimbursement, competition) and a high degree of reliance on partners. The key stock-specific sensitivities are connected to the outcomes of the regulatory filing of Selincro, of the tozadenant Phase IIb trial, and business development efforts related to SYN120, BTT-1023 and ronomilast. Positive outcomes for these events should enhance Biotie’s share price and financial situation – in particular, Biotie is due significant milestones/royalties payable on the successful development and commercialisation of Selincro and tozadenant – although they will not address the company’s 2012/13 funding requirement in its entirety: Biotie will need to raise additional funds during 2012. Future business development and/or M&A activity is also expected.

Valuation

Despite Roche’s decision not to opt-in to SYN120 development, we have made no changes to our assumptions for this programme at this stage on the basis of management confidence that they will license SYN120 in the near term. We have, however, revised our assumptions on BTT-1023 as future development will be focused on fibrotic disorders (where there may be potential for premium pricing) rather than the increasingly competitive disease area.

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Biotie Therapies | 6 July 2012

We now ascribe a €243m rNPV valuation of Biotie (previously €250m), based on a risk-adjusted net present value of Biotie’s five core R&D assets using a 12.5% cost of capital and assuming a base running cost for the business. This compares with a €115m EV, excluding the Tekes loan. Model output and assumptions are summarised in Exhibit 3.

Exhibit 3: Biotie’s core business rNPV model Product(s) Status Probability Estimated Estimated peak Current market Estimated max. Estimated peak of success launch year market share value royalty sales Selincro Registration 90% 2012 50% $750m 15% $567m (alcohol dependency) Ronomilast Phase II 35% 2016 3% $15,000m 18% $681m (COPD/ asthma) BTT-1023 Phase II 35% 2017 15% $750m 15% $234m (fibrotic disease) Tozadenant/SYN115 Phase II 35% 2018 6% $2,750m 15% $265m (Parkinson's disease) SYN120 Phase I 15% 2019 5% $5,000m 10% $602m (cognitive disorders) Source: Edison Investment Research

This valuation will increase as products successfully progress through clinical development (and the regulatory process), justifying higher probabilities of success. We will make any necessary updates to our assumptions as further development plans are disclosed. Significant milestones from Lundbeck (up to €72m) and UCB (up to c $370m) may be payable, contingent on successful development and commercialisation of partnered assets; these are not captured in our model as the payment schedules and triggers are undisclosed. Our valuation could also be considered conservative as it: (1) takes a cautious view on the potential Selincro market, reflecting in part the fact that US commercialisation (for IP reasons) is unlikely; (2) only considers the lead indication for each programme (label extension would boost potential value); (3) does not currently include SYN117 (nepicastat) as further development is contingent on securing additional external funding; and (4) does not value the biocrea minority interest.

Financials

Biotie’s cash and equivalents of €24.7m at end-March 2012 provide funding into 2013 (we forecast 2012e gross cash of €1.9m) in the absence of additional revenue receipts. We show a €35m+ funding requirement in 2013 (reflected for modelling purposes as an increase in short-term debt), although we expect this to be somewhat offset by potential payments from existing or new partners, and/or addressed via an equity raise during 2012. Potential payments include the next Selincro milestone from Lundbeck, assumed on launch (potentially Q113), and an undisclosed tozadenant milestone from UCB on clinical progress (potentially in 2013, on Phase IIb data or Phase III trial initiation). Biotie also has the ability, under its discretion, to raise up to €20m in additional capital under its Standby Equity Distribution Agreement facility with Yorkville until September 2012 (€1.1m has been drawn to date). Biotie’s long-term financial liabilities of €23.5m mostly relate to loans from Tekes, which are largely repayable only on sustainable profitability).

Edison’s financial forecasts (shown in Exhibit 4 overleaf) assume no future M&A activity, milestone revenue or out-licensing of any existing programmes, only considering the deferred recognition of previous upfront payments from partners. As a base case, we assume R&D spend of €20m in 2012 (covering the cost of the SYN115 Phase IIb study, the completed SYN120 PET receptor occupancy trial plus some R&D spend on other core programmes such as BTT-1023) and 2013 (while partners are expected to take on responsibility for carrying out and funding later-stage clinical development, Biotie will fund studies of other R&D assets). G&A of €9m is forecast for 2012 and €9.5m in 2013.

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Biotie Therapies | 6 July 2012

Exhibit 4: Financial summary Year end 31 December €'000s 2009 2010 2011 2012e 2013e Accounting basis IFRS IFRS IFRS IFRS IFRS PROFIT & LOSS Revenue 5,628 1,955 1,007 120 120 Cost of sales 0 0 0 0 0 Gross profit 5,628 1,955 1,007 120 120 EBITDA (11,832) (7,269) (28,310) (27,180) (28,580) Operating profit (before GW and except) (12,230) (7,633) (28,310) (27,180) (28,580) Intangible amortisation 0 0 0 0 0 Exceptionals (5,400) (13,111) (13,200) 0 0 Currency translation differences 0 0 5,449 0 0 Operating profit (17,630) (20,744) (36,061) (27,180) (28,580) Net interest (311) (829) 2,028 (800) (1,000) Profit before tax (norm) (12,541) (8,462) (20,833) (27,980) (29,580) Profit before tax (FRS 3) (17,941) (21,573) (34,033) (27,980) (29,580) Tax 1,859 0 7,755 2,000 600 Profit after tax (norm) (10,682) (8,462) (13,078) (25,980) (28,980) Profit after tax (FRS3) (16,082) (21,573) (26,278) (25,980) (28,980) Average number of shares outstanding (m) 145.5 163.1 370.0 387.6 387.6 EPS - normalised (c) (7.3) (5.2) (3.5) (6.7) (7.5) EPS - FRS 3 (c) (11.1) (13.2) (7.1) (6.7) (7.5)

BALANCE SHEET Fixed assets 10,241 5,885 82,446 82,660 82,710 Intangible assets 7,565 4,042 80,755 80,755 80,755 Tangible assets 2,666 365 305 405 455 Investment in associates 10 1,478 1,386 1,500 1,500 Current assets 21,285 5,320 35,790 4,157 3,014 Debtors 1,507 1,261 1,852 2,300 2,300 Cash 19,778 4,059 33,769 1,857 714 Other 0 0 169 0 0 Current liabilities (6,060) (6,792) (10,303) (5,318) (41,198) Group borrowings (3,890) (3,242) (10,067) (5,082) (5,082) Current financial liabilities (217) (2,544) (116) (116) (36,116) Deferred revenue (1,953) (1,006) (120) (120) 0 Long-term liabilities (34,404) (33,880) (34,596) (35,181) (35,787) Long-term borrowings (25,597) (25,640) (23,492) (24,197) (24,923) Provisions (160) 0 0 0 0 Other long-term liabilities (8,647) (8,240) (11,104) (10,984) (10,864) Net assets (8,938) (29,467) 73,337 46,318 8,739 CASH FLOW Operating cash flow (11,408) (14,867) (21,171) (31,717) (28,580) Net interest (58) 0 78 (800) (1,000) Tax (1,859) 0 6 0 0 Capex (165) 0 0 (100) (50) Expenditure on intangibles 0 (54) (65) 0 0 Acquisitions/disposals 0 0 16,339 0 0 Financing 7,202 (797) 27,870 0 0 Dividends 0 0 0 0 0 Net cash flow (6,288) (15,718) 23,057 (32,617) (29,630) Opening net debt/(cash) (295) 6,036 21,725 (1,922) 30,695 Other (43) 29 590 0 0 Closing net debt/(cash) 6,036 21,725 (1,922) 30,695 60,325 Source: Edison Investment Research

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