Slide 1: Orion Capital Markets Day 2015
Orion Capital Markets Day 2015 26 May 2015 Helsinki
Slide 2: Agenda
Agenda CEO’s review Timo Lappalainen, President & CEO R&D pipeline review, part I Reijo Salonen, SVP, Research & Development Break Proprietary Products update Markku Huhta-Koivisto, SVP, Proprietary Products Specialty Products update Liisa Hurme, SVP, Proprietary Products CFO’s presentation Jari Kar
Slide 3: Forward-looking statements
This presentation contains forward-looking statements which involve risks and uncertainty factors. These statements are not based on historical facts but relate to the Company’s future activities and performance. They include statements about future strategies and anticipated benefits of these strat
Slide 4: CEO's presentation
CEO’s presentation CEO Timo Lappalainen
Slide 5: Development since CMD in 2013
Development since CMD in 2013
Slide 6: Key developments 2012 to 2014
Key developments 2012 to 2014 dexdor® + Partnerships with Janssen and +22 MEUR Easyhaler Bayer +8 MEUR + 7 new projects in clinical Specialty Products developement pipeline +60 MEUR Other business +41 MEUR + Stalevo for Japan + First approvals of Bufomix – 3 development projects Branded PD discontin
Slide 7: Financial performance in 2010-2014
Financial performance in 2010-2014 Net Sales 2010-2014 Operating Profit 2010-2014 EUR million EUR million 1200 12% 300 32% 1000 10% 250 31% 800 8% 200 30% 600 6% 150 29% 400 4% 100 28% 200 2% 50 27% 0 0% 0 26% 2010 2011 2012 2013 2014 2010 2011 2012 2013 2014 Operating profit Net sales Annual growth
Slide 8: Net sales by business division 2010-2014
Net sales by business division 2010-2014 EUR million 1200 1000 800 69 71 70 68 68 600 321 367 385 427 299 400 118 142 154 184 204 200 253 267 250 207 169 0 2010 2011 2012 2013 2014 Entacapone products Other Proprietary Products Specialty Products Animal Health Fermion Contract Manufacturing Diagnost
Slide 9: Development of key PP products and milestones
Development of key PP products and milestones Orion milestone history* EUR million EUR million 400 60 350 50 300 250 40 200 30 150 20 100 50 10 0 0 2010 2011 2012 2013 2014 Branded PD Simdax Precedex Easyhaler dexdor® *) essential milestones 9 26 May 2015 Orion Capital Markets Day 2015
Slide 10: The way forward - Orion's strategy
The way forward - Orion's strategy
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Slide 16: Balancing mid-term − building long-term
Balancing mid-term − building long-term Long-term growth opportunities from R&D pipeline. Milestone payments. Generic drugs and self-care products. Generic competition for Parkinson’s franchise and Precedex. Timing of milestone payments. Easyhaler® combinations and dexdor® for European markets. Glob
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Slide 18: R&D pipeline review part I
R&D pipeline review part I Reijo Salonen SVP, Research & Development
Slide 19: Best R&D Pipeline
Best R&D Pipeline GRION Building well-being
Slide 20: Transformation journey of Orion Pharma R&D
Transformation journey of Orion Pharma R&D toward the Best R&D in the world 2017 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 Best Strategy Smart to POC Best Leadership • Smart planning Best Make it stick • Capabilities (Project Science Best Structure ecosystem) Best Image Continous reorganizat
Slide 21: Pharmaceutical R&D portfolio 2015 1/2
Pharmaceutical R&D portfolio 2015 1/2 Project Indication PHASE Registration Bufomix Easyhaler® (budesonide-formoterol) 1) Asthma, COPD I II III Easyhaler® salmeterol-fluticasone Asthma, COPD I II III ODM-201 (androgen receptor inhibitor) 2) Prostate cancer I II III Low Cardiac Output Levosimendan 3)
Slide 22: Pharmaceutical R&D portfolio 2015 2/2
Pharmaceutical R&D portfolio 2015 2/2 Project Indication PHASE Registration ODM-104 (more effective COMT inhibitor) Parkinson’s disease I ODM-203 (targeted FGFR+VEGFR inhibitor) Solid tumours I ODM-204 (CYP17 enzyme and androgen receptor inhibitor) Prostate cancer I ODM-106 (GABA-B receptor positive
Slide 23: Easyhaler
Easyhaler
Slide 24: Bufomix Easyhaler
Bufomix Easyhaler® • Application for marketing authorisations in some countries left out from the 1st DCP round for 160/4.5 and 320/9 µg/inhal. strengths • The further development plans are based on experiences from the 1st DCP round and authority consultations increasing our confidence in obtaining
Slide 25: BUFODIL study
BUFODIL study Bufomix Easyhaler® (budesonide-formoterol) Asthma, COPD I II III • A study to confirm equivalent bronchodilator efficacy of Bufomix Easyhaler compared to Symbicort Turbuhaler in adult asthmatics • Randomised, double-blind, double-dummy, multicentre, single dose, crossover study • Asthm
Slide 26: Salmeterol-Fluticasone Easyhaler
Salmeterol-Fluticasone Easyhaler® Easyhaler® salmeterol-fluticasone Asthma, COPD I II III • Development of Salmeterol-Fluticasone Easyhaler® is in clinical phase • We have utilized the learnings from Bufomix Easyhaler® development which have significantly increased our understanding of the regulator
Slide 27: ODM-201
A novel second generation ODM-201 androgen receptor (AR) inhibitor for the treatment of castration resistant prostate cancer In collaboration with Bayer
Slide 28: ODM-201 has a unique profile
ODM-201 has a unique profile Enzalutamide 19%* ODM-201 3% ** ARN-509 29%* Enzalutamide ARN-509 ODM-201 general structure AR Antagonism IC50 (nM) Proliferation Compound affinity AR AR AR VCaP Ki (nM) WT AR IC50 (nM) (F876L) (T877A) (W741L) Bicalutamide 12 150 218 957 Agonist Enzalutamide 86 155 Agoni
Slide 29: ODM-201 Clinical studies
ODM-201 Clinical studies Daily Dose ClinicalTrials. Study Phase Populations N Status gov identifier (mg) mCRPC* • Chemo/CYP17 naïve ARADES I/II • Post chemo/ CYP17 naïve 134 200-1800 Completed NCT01317641 • Post CYP17 mCRPC* ARADES • Chemo/CYP17 naïve II 76 200-1800 Ongoing NCT01317641 ext • Post ch
Slide 30: ODM-201 antitumour activity in phase I/II studies
ODM-201 provided antitumour activity with mCRPC patients in phase I/II studies (ARADES and ARAFOR) Radiographic progression, product-limit survival estimate with number of subjects at risk ODM-201 with daily doses between 1200- 1800 mg was well tolerated and provided antitumor activity in patients w
Slide 31: ODM-201 Phase III study in nmCRPC
ODM-201 Phase III study ongoing in non-metastatic castration resistant prostate cancer (nmCRPC) ODM-201 (androgen receptor inhibitor) 2) Prostate cancer I II III • nmCRPC patients who are at high risk for developing metastatic disease are included (n=1500) • Primary endpoint – ODM-201 over placebo i
Slide 32: ODM-203
A unique and selective dual ODM-203 FGFR+VEGFR inhibitor for FGFR-dependent tumors
Slide 33: Rationale for combining FGFR and VEGFR inhibition
Rationale for combining FGFR and VEGFR inhibition Constitutively active FGFRs are oncogenic in non-clinical studies Both VEGFR and FGFRs are drivers for angiogenesis, a hallmark of tumorigenesis FGFR amplifications have an impact on patient survival in studied cancer types (breast, lung, and gastric
Slide 34: Angiogenic indications with altered FGFR signalling
Angiogenic indications with altered FGFR signalling Tumor type Genomic alterations of FGFRs and FGFs Breast (luminal) ~35% (FGFR1 amp, FGFR2 amp, FGFR4 amp, FGFs) NSCLC-SCC ~20% (FGFR1 amp, FGFR2 amp) Bladder (invasive) ~15% (FGFR3 fusions, FGFR1 amp, FGFs) Prostate ~14% (FGFR1 amp, FGFR2&3 fusions)
Slide 35: Competitive landscape for small molecule FGFR inhibitors
Current competitive landscape for small molecule FGFR inhibitors No FGFR inhibitor on the market Inhibitor selectivity Dual FGFR+VEGFR FGFR PanTKI/FGFR BAY1163877 Phase II Phase I FGF401 Debio 1347 ODM-203 Clinical development JNJ42756493 AL3818 TAS120 NVP-BGJ398 Lucitanib AZD4547 Phase III Dovitini
Slide 36: ODM-203 equally balanced selective dual FGFR/VEGFR inhibitor
ODM-203 seems to be the only equally balanced selective dual FGFR/VEGFR inhibitor In vitro kinase activity Cell based activity Ratio ODM-203 Lucitanib Cell line (receptor), Ratio ODM-203 Lucitanib FGFR1/VEGFR2 1:1 1:6 FGFR/Angiogenesis 1:2 1:100 • ODM-203 has very high kinase selectivity against FGF
Slide 37: ODM-203 has strong in vivo antitumor activity
ODM-203 has strong in vivo antitumor activity FGFR xenograft model (RT4) Angiogenic kidney cancer model (Renca) 600 500 400 300 200 100 0 0 2 4 6 8 10 12 14 16 18 20 Treatment day Vehicle control p.o. Selective FGFRi (12.5 mg/kg) ODM -203 (20 mg/kg) ODM -203 (40 mg/kg) • Superior activity in angioge
Slide 38: ODM-203 – current status
ODM-203 – current status ODM-203 (targeted FGFR+VEGFR inhibitor) Solid tumours I • Phase I KIDES trial ongoing • Safety and Tolerability of ODM-203 in Subjects With Advanced Solid Tumours (KIDES-203) ClinicalTrials.gov identifier: NCT02264418 38 26 May 2015 Orion Capital Markets Day 2015
Slide 39: ODM-204
Target: ODM-204 Best-in-class treatment for metastatic Castration Resistant Prostate Cancer (mCRPC)
Slide 40: Positioning of ODM-204
Positioning of ODM-204 CRPC AR F876L AR-V7 Post Xtandi / Zytiga Non- Pre-Chemo Post-Chemo metastatic Metastatic Metastatic Metastatic Zytiga Zytiga Xtandi Xtandi ODM-201 ODM-204 Note: Zytiga/Xtandi combination trials are ongoing 40 26 May 2015 Orion Capital Markets Day 2015
Slide 41: Target product profile in mCRPC
Target product profile in mCRPC* Xtandi Zytiga Galeterone ODM-204 (Enzalutamide) (Abiraterone) (TOK-001) CYP17A1 AR inhibitor CYP17A1 CYP17A1 Mechanism inhibitor+ inhibitor inhibitor AR inhibitor CYP17A1 inhibition ++ - +++ ++ AR binding/activity +++ ++ - (+) In vitro efficacy in VCaP cells +++ + +
Slide 42: ODM-204 – current status
ODM-204 – current status ODM-204 (CYP17 enzyme and androgen receptor inhibitor) Prostate cancer I • Phase I/II DUALIDES trial ongoing – Safety and Pharmacokinetics of ODM-204 in Patients With Metastatic Castration-Resistant Prostate Cancer (DUALIDES) – Subgroups: Number of CYP17A1i Second-generation
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Slide 44: Break
Break 44 26 May 2015 Orion Capital Markets Day 2015
Slide 45: Proprietary Products Update
Proprietary Products Update Markku Huhta-Koivisto, SVP Proprietary Products
Slide 46: Orion's partnering strategy
Orion’s partnering strategy is based on profitable growth and increased shareholder value whilst keeping business risk under control Late stage Research Early development development Candidate Target Hit to Lead Lead selection, identification Phase I Phase II Phase III generation optimisation precli
Slide 47: Key late stage development partnerships
Key late stage development partnerships Partnership with Janssen on ORM-12741 Partnership with Bayer on ODM-201 for for treatment of symptoms of AD treatment of prostate cancer Commercial territories Commercial territories • Orion: Europe • Bayer: Global rights • Janssen: RoW • Orion: Co-promotion o
Slide 48: Partnering opportunities in the pipeline
Partnering opportunities in the pipeline Project Indication PHASE Registration ODM-109 (oral levosimendan) ALS I II ODM-104 (more effective COMT inhibitor) Parkinson’s disease I ODM-203 (targeted FGFR+VEGFR inhibitor) Solid tumours I ODM-204 (CYP17 enzyme and androgen receptor inhibitor) Prostate ca
Slide 49: Sales of key proprietary products
Sales of key proprietary products 2014 First Bufomix MAs in 2011 EUR million 450 Europe Dexdor launched 400 2014 2012 Gx entacapone* 350 First generic Stalevo First generic in Germany Comtan in USA 300 Stalevo 250 2014 2012 Comtan/Comtess 200 First generic First generic Precedex in USA Stalevo in US
Slide 50: Easyhaler update
Easyhaler update EUR million Easyhaler net sales 14 Bufomix 12 Available strengths: 10 160/4.5 µg/inhal 320/ µg/inhal 8 Sales started in more 6 than 10 countries MA in 23 countries 4 (excluding Germany, 2 France, UK, The Netherlands and 0 Austria) Q112 Q212 Q312 Q412 Q113 Q213 Q313 Q413 Q114 Q214 Q3
Slide 51: Easyhaler combinations main target market
Easyhaler combinations main target market B2-STIMULANTS+CORTICOIDS CLASS (R3F) SALES IN EUROPE 2014 Total market: EUR 3.4 billion (+0.7%) 2% 13% Salmeterol/fluticasone Budesonide/formoterol 51% 34% Beclometasone/formoterol Total Others (4) 51 26 May 2015 Orion Capital Markets Day 2015
Slide 52: Dexdor update
Dexdor update EUR million Dexdor net sales 12 ICU patent until 2019 Data protection until 10 2021 8 Updated positioning to drug of choice to 6 optimize PAD (pain, agitation & delirium) 4 management Added value justified 2 by health economic publications and 0 models Q112 Q212 Q312 Q412 Q113 Q213 Q31
Slide 53: Dexdor gaining market share
Dexdor gaining market share European sedative market 2013 European sedative market 2014 Total market value EUR 494 million Total market value EUR 509 million 4.5 % 12.1 % 5.5 % 12.4 % 16.0 % 14.9 % 67.4 % 67.2 % Propofol Midazolam Propofol Midazolam Dexmedetomidine Remifentanil Dexmedetomidine Remif
Slide 54: Simdax update
Simdax update EUR million Simdax net sales 14 12 Molecule patent 10 expires Sep 2015 8 Formulation patent valid until Sep 2020 6 MA received in 4 Germany and Switzerland Q4/2013 2 0 Q112 Q212 Q312 Q412 Q113 Q213 Q313 Q413 Q114 Q214 Q314 Q414 Q115 Study results available for Low Cardiac Output Syndro
Slide 55: NO 109) bth,
NO 109) bth,
Slide 56: Orion Specialty Products with strong foothold in Nordics
Orion Specialty Products with strong foothold in Nordics Liisa Hurme SVP, Specialty Products Chairman of the Board, Fermion
Slide 57: SpP division has generated steady sales growth
SpP division has generated steady sales growth Breakdown of SpP (Gx & OTC)net sales Development of SpP net sales (Gx & OTC) by geographic area MAT Q1 2015 from 2006 to MAT Q1 2015 Finland Net Sales 9% 450 6% Scandinavia 400 EUR million 350 13% Eastern Europe 300 & CIS 250 60% Other Europe 200 12% Ot
Slide 58: Strong SpP growth in Finland with Gx and OTC
Strong SpP growth in Finland with Gx and OTC In MAT Q1 2015, Orion human pharmaceutical total sales in Finland was EUR 281 million (+9%) of which SpP was EUR 260 million (+10%) and out of that Self Care was EUR 87 million (+2%) EUR million 300 250 200 Finland SpP 150 +10% 100 50 0 2006 2007 2008 200
Slide 59: Strong growth in Scandinavia driven by Gx
Strong growth in Scandinavia driven by Gx Norway In MAT Q1 2015, Orion human pharmaceutical SpP total sales in Scandinavia was EUR 82 million +206% (+14%) of which SpP was EUR 53 million (+20%) and mainly Gx driven Sweden SpP +16% EUR million 60 50 40 30 20 Denmark 10 SpP -3% 0 2006 2007 2008 2009 2
Slide 60: Steady growth also throughout Eastern Europe
Steady growth also throughout Eastern Europe Orion human pharmaceutical total sales in Eastern Europe EUR 79 million MAT Q1 2015 (+6%) of which sales in top 2 SpP countries were: Russia EUR 19 million Poland EUR 19 million Russia SpP EUR million -2% 60 50 40 30 20 10 Poland 0 SpP +22% 2006 2007 2008
Slide 61: Orion Gx business has outperformed market growth
Orion Gx business has outperformed market growth • Nordic region is Orion’s home Scandinavia Orion Finland Orion base for generic products 3% 27% 6% 11% • Orion has been able to grow faster than the market in Nordics Russia Orion -7% -7% • Two digit growth in Poland exceeding the market Poland Orion
Slide 62: Orion's position at Gx markets is well established
Orion’s position at Gx markets is well established Top Gx companies in Finland In Sweden Orion is one of 200 15% the fastest growing Gx companies Growth% 2014 vs. 2013 10% Ranking Company Gx Growth% 150 Sweden 10% EUR million 5% #1 Sandoz 39% 100 #8 Orion 33% 0% Denmark 6% 50 #1 Sandoz 5% -5% #7 Ori
Slide 63: Key characteristics of Nordic Gx markets
Some key characteristics of Nordic Gx markets Substitution Primary care pricing Distribution Hospital market system cycle and process channel Reference priced Gx 20 health care products with quarterly Single channel YES regions & 5-6 pricing and re- regional tenders imbursement cycle 21 health care
Slide 64: Key success factors of Scandinavian Gx business
Key success factors of Scandinavian Gx business Broad customer Several unique Rx Entry into base products biosimilars Through the broad Global network of portfolio Orion has Large portfolio quality suppliers developed multichannel sales processes to meet the needs of our key customer groups in a Sol
Slide 65: Key success factors of Finnish Gx business
Key success factors of Finnish Gx business Fast growth of Commercialisation Strong OTC OTC non- and customer market share medicinal processes portfolio Orion active with Wide portfolio of Several Rx/OTC all customer hospital products switches lately groups Large portfolio Several unique Rx (~300 bra
Slide 66: Positive outlook for continued growth in all markets
Positive outlook for continued growth in all markets Market share development of Orion Gx Gx market size in 2014 (mEUR) 4% Norway % of total Gx sales 227 Sweden 3% Denmark 517 340 2% 2009 2014 1% Finland 419 0% Sweden Denmark Norway Poland Source: IMS Health 2009 vs. 2014 Gx market growth estimates
Slide 67: Looking into the future of Gx business
Looking into the future of Gx business 67 26 May 2015 Orion Capital Markets Day 2015
Slide 68: Strategic actions for Specialty Products
Strategic actions for Specialty Products OTC: Keep the market share and grasp the non-medicinal market trend with new products Gx Pharmacy: Ensure constant flow and renewal of the porfolio with competitive COGS Gx Hospital: Keep and grow 68 26 May 2015 Orion Capital Markets Day 2015
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Slide 70: CFO's presentation
CFO’s presentation CFO Jari Karlson
Slide 71: Orion's financial objectives
Orion’s financial objectives Increasing net sales. Achievement of this objective requires continuous investment in development of the product portfolio. Maintaining profitability at a good level. The aim is operating profit that exceeds 20% of net sales. Keeping the equity ratio at least 50%. Distri
Slide 72: Orion's financial objectives
Orion’s financial objectives Increasing net sales. Achievement of this objective requires continuous investment in development of the product portfolio. Maintaining profitability at a good level. The aim is operating profit that exceeds 20% of net sales. Keeping the equity ratio at least 50%. Distri
Slide 73: Financial objectives and outlook 2015
Orion’s financial objectives and outlook 2015 Net sales 1,200 12% 1,000 10% 800 8% Net sales will be slightly lower Net sales, EUR Net sales than in 2014 (net sales were 600 6% million 400 4% EUR 1,015 million in 2014). Growth, % 200 2% - 0% Operating profit 300 35% 250 30% Operating profit, 200 25%
Slide 74: Turning points of Parkinson's franchise
Turning points of Parkinson’s franchise Annual in-market sales, EUR million* Orion sales, EUR million 700 300 600 250 500 200 400 150 300 100 200 100 50 0 0 2011 2012 2013 2014 Comtan USA Stalevo USA Comtess/Comtan Europe Stalevo Europe Generic entacapone Stalevo, Comtess & Comtan Comtan Japan Stale
Slide 75: Balancing mid-term − building long-term
Balancing mid-term − building long-term Long-term growth opportunities from R&D pipeline. Milestone payments. Generic drugs and self-care products. Generic competition for Parkinson’s franchise and Precedex. Timing of milestone payments. Easyhaler® combinations and dexdor® for European markets. Glob
Slide 76: Collaborative networks across the R&D value chain
Collaborative networks across the R&D value chain Late stage Research Early development development Target Hit to Lead Lead Candidate Phase I Phase II Phase III identification generation optimisation selection, and validation preclinical dev. 8–24 mth 12–24 mth 18–36 mth 12–24 mth 12–14 mth 12–36 mt
Slide 77: Orion's financial objectives
Orion’s financial objectives Increasing net sales. Achievement of this objective requires continuous investment in development of the product portfolio. Maintaining profitability at a good level. The aim is operating profit that exceeds 20% of net sales. Keeping the equity ratio at least 50%. Distri
Slide 78: Financial objectives and outlook 2015
Orion’s financial objectives and outlook 2015 Equity ratio and interest-bearing liabilities 300 70% 250 60% Interest-bearing liabilities, EUR 200 50% million 150 40% Equity ratio, % The Group’s capital 100 30% Equity ratio expenditure will be about 50 20% target >50 % Group’s EUR 50 million excludin
Slide 79: Capex normalising after investment program
Capex normalising after investment program EUR million 80 70 60 50 40 30 20 10 0 2007 2008 2009 2010 2011 2012 2013 2014 2015* *) Estimate for Intangible assets 2015 Property, plant and equipment Depreciation, amortisation and impairment 79 26 May 2015 Orion Capital Markets Day 2015
Slide 80: Development of Net working capital
Development of Net working capital % of net sales EUR million 40% 300 30% 200 20% 100 10% 0 0% -10% -100 -20% -200 Receivables Receivables Inventories Inventories Short-term non-interest bearing liabilities Short-term non-interest bearing liabilities Net Working Capital Net Working Capital 80 26 May
Slide 81: Development of Net working capital
Development of Net working capital (Indexed 12/2012=100) 12/2012 = 100 150 140 130 120 110 100 90 80 12/12 3/13 6/13 9/13 12/13 3/14 6/14 9/14 12/14 Receivables Rolling 12mth Net sales Inventories Net Working Capital Liabilities 81 26 May 2015 Orion Capital Markets Day 2015
Slide 82: Equity structure and Profit distribution
Equity structure and Profit distribution Orion Orion 31 Dec 2014 (EUR million) Corporation Group Share capital 92.2 92.2 Of these 183 million was Reserves 1.4 -44.4 distributed in March 2015 Retained earnings left EUR Orion Corporation 254.6 254.6 0,51/share Subsidiaries 75.7 IFRS and Consolidatio
Slide 83: Funding of dividends
Funding of dividends EUR/share 2.50 2.25 Minimum dividend target (1,20/share) 2.00 1.75 Repayment of 1.50 current debt 1.25 1.00 EPS with 230 million EBIT 0.75 0.50 EPS with 230 million 0.25 EBIT + cash after 0.00 2014 dividends 2015 2016 2017 2018 EPS to be quite close to free cash flow assuming •
Slide 84: rem
rem - pak Seen ep pe Nah M i y GRION Building well-being
Slide 85: Break
Break 85 26 May 2015 Orion Capital Markets Day 2015
Slide 86: Orion Animal Health
Orion Animal Health Niclas Lindstedt Vice President
Slide 87: Orion Pharma Animal Health
Orion Pharma Animal Health • 2014 sales EUR 71.5 million • Part of the top 30 Animal Health Companies Globally* • Animal Health division of Orion consists of 68 people, in 8 countries – 40 people in sales in Nordics – 20 people in sales in CEE – 8 people HQ function • Sales by species: 60% companion
Slide 88: Orion Pharma Animal Health European presence
Orion Pharma Animal Health European presence Orion Pharma Animal Health Captive Market Romania and Slovenia: through a distributor Our product portfolio consists of both medicinal and non-medicinal products for animals. 88 26 May 2015 Orion Capital Markets Day 2015
Slide 89: Partners
Partners 89 26 May 2015 Orion Capital Markets Day 2015
Slide 90: Orion Pharma Animal Health
Orion Pharma Animal Health New innovations Orion Pharma Animal Health Out- In- licensed licensed products products 90 26 May 2015 Orion Capital Markets Day 2015
Slide 91: Sileo
Sileo ® alleviates acute fear and anxiety associated with noise
Slide 92: Sileo: First approved medicine for noise anxiety in dogs
Sileo® First approved medicine for noise anxiety in dogs SILEO INDICATION: Alleviation of acute anxiety and fear associated with noise in dogs • Positive opinion for marketing authorisation from the European Committee of Medicinal Products for Veterinary Use received 10th April 2015 • Dog owners are
Slide 93: ODM-105 Orally active alpha-2 agonist
ODM-105 Orally active alpha-2 agonist
Slide 94: ODM-105
ODM-105 First alpha-2 agonist that is active even when swallowed Target species: dog and cat Part of Orion´s own research and development pipeline Several potential indication areas in behavior, pain management and sedation / anesthesia 94 26 May 2015 Orion Capital Markets Day 2015
Slide 95: Non-medicinal portfolio
Non-medicinal portfolio • Joints & mobility • Digestion • Skin & Fur • Eye & Ear • W ound Healing • M outh Hygiene • Energy & Nutritional Supplements 26 May 2015 Capital Markets Day 2015
Slide 96: Orion development in Derma line
Orion development in Derma line Cr eated by a leading Derma Swedish der matologist, Shampoo an innovative, high-quality ther apy appr oach Skin barrier tar geting the r oot cause of repair is sensitive skin; fundamental Derma str engthening Gel the skin bar r ier, effective combination of antimicr o
Slide 97: Morrr
Morrr® | \\ Solutions to find \ trusted providers Ee * MORRR.COM @MORRR LTD 2015 TREAT ME RIGHT
Slide 98: Orion Building well-being
GRIoN Building well-being
Slide 99: Fermion
Fermion Arto Toivonen President
Slide 100: Fermion in Brief
Fermion in Brief Fully owned subsidiary of Orion Corporation Develops, manufactures and sells active pharmaceutical ingredients (APIs) Business segments: • NCEs for Orion’s existing and new proprietary products • Generics to Orion and other pharmaceutical companies worldwide • Custom development and
Slide 101: Global API Market
Global API Market • 113 B$ in 2012 of which ca. 61% is captive and 39% merchant • Annual growth rates 2008-2012: 13.9% Asia-Pacific, 3.8% N-America, 2.5% W-Europe • Growth rate high > 20% in oncology • High potency APIs (HAPIs) is a fast growing segment • Global market estimated to reach ca. 144 B$
Slide 102: Fermion Production - Chemistry in Pharmaceutical Environment
Fermion Production - Chemistry in Pharmaceutical Environment Strong regulatory authorities’ (FDA, FIMEA, PMDA, MOH, KFDA, ANVISA) inspection track record HANKO • Fully automated • High volume products • Reactor capacity 240 m3 OULU • Fully automated • Specialty products • Both cytotoxics and non-cyt
Slide 103: Captive Business – Strategic fit with Orion Pharma
Captive Business –Strategic fit with Orion Pharma creating valuable synergy Exclusive supply of APIs for Orion’s proprietary products: • Atipamezole HCl • Detomidine HCl • Dexmedetomidine HCl • Entacapone • Medetomidine HCl • Levosimendan • Toremifene citrate Orion’s strengthened clinical pipeline
Slide 104: Strong Market Position with a Number of Generic APIs
Strong Market Position with a Number of Generic APIs Antineoplastic Central Nervous System • Mercaptopurine* • Buspirone HCl* • Methotrexate* • Fluoxetine HCl • Flutamide* • Trazodone HCl • Azathioprine* • Alprazolam • Irinotecan HCl • Quetiapine Fumarate • Carbidopa Cardiovascular Others • Propafen
Slide 105: Custom Development and Manufacturing Services – Key differentiators
Custom Development and Manufacturing Services – Key differentiators Capability to manufacture high potency APIs from gram to multi-ton scale Regulatory-compliant, fully automated best-in-class facilities Strong experience and leading talents in crystallization, particle size engineering and impurity
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Slide 107: Orion Diagnostica
Orion Diagnostica Jaakko Rissanen President
Slide 108: Orion Diagnostica Figures in a nutshell
Orion Diagnostica Figures in a nutshell • In 2014 net sales 56.4 m€ (-1%)* • Over 80% from international sales • Operating profit 6.4 m€ (+38%) • Main market areas: Europe (especially northern), China, USA, Japan • Own Sales Units in Finland, Sweden, Norway, Denmark, Czech Republic, Slovak Republic,
Slide 109: Smart Solutions for Healthcare & Hygiene Monitoring
Smart Solutions for Healthcare & Hygiene Monitoring Orion Diagnostica is a mid- We develop, manufacture and sized, reliable European IVD market diagnostic test systems for company with over 40 years healthcare professionals especially experience. in point-of-care. Orion Capital Markets Day 2015 26 M
Slide 110: We operate in the IVD growth segments
We operate in the IVD growth segments HUMAN IVD MARKET (Kalorama, 2013 figures) USA Europe China Japan ROW Global CAGR USD billion % Global IVD market 24.4 15.2 1.7 4.8 8.5 54.6 4 - Professional POC 6.0 4 - POC for OTC and self-testing 8.9 - Core lab 39.7 Global POC market (Prof & OTC) 9.8 7.0 0.9 1
Slide 111: Our customers
Our customers Point-of-Care Small and mid-size Infection control, laboratories industrial microbiology Orion Capital Markets Day 2015 26 May 2015 111
Slide 112: Orion Diagnostica – Building well-being
Orion Diagnostica – Building well-being A forerunner in point-of-care systems with immunological IVD POC products deployed already in the 1990s. Our flagship product with ca 40.000 units installed globally, is the rapid, easy-to-use QuikRead go® CRP. Orion Capital Markets Day 2015 26 May 2015 112
Slide 113: QuikRead go: Your support in treatment decisions
QuikRead go® Your support in treatment decisions Helps to target antibiotic treatment to those who really need it Reduced risk for antibiotic resistance and cost savings in healthcare wrCRP wrCRP+Hb CRP CRP+Hb hsCRP+Hb Strep A iFOBT More to follow… Orion Capital Markets Day 2015 26 May 2015 113
Slide 114: Orion Diagnostica – Building well-being
Orion Diagnostica – Building well-being Our newest platform on the European markets is Orion GenRead®. It is based on SIBA®, a novel isothermal molecular diagnostics technology. It brings flexible and easy detection of pathogens for laboratories of various settings and sizes. The first tests with lo
Slide 115: Conventional PCR vs. Isothermal NAT
Conventional PCR vs. Isothermal NAT Some features as presented in 2013 2015 ++ ++ ++ ++ Orion Capital Markets Day 2015 26 May 2015 115
Slide 116: SIBA – Benefits
SIBA® – Benefits Orion Capital Markets Day 2015 26 May 2015 116
Slide 117: Orion GenRead: Molecular testing for healthier life
Orion GenRead® Molecular testing for healthier life Based on SIBA®, a novel isothermal molecular diagnostics technology Flexible and easy pathogen detection for any laboratory C. difficile Salmonella More to follow… Orion Capital Markets Day 2015 26 May 2015 117
Slide 118: Market Entry in In Vitro Diagnostics
Market Entry in In Vitro Diagnostics COUNTRY X Sales channel Clinical acceptance Laboratory acceptance Payer exists Trial(s) at end user Procurement process Purchase decision ROUTINE USE = SALES CAN START! Orion Capital Markets Day 2015 26 May 2015 118
Slide 119: Market Entry in In Vitro Diagnostics
Market Entry in In Vitro Diagnostics Clinical Laboratory Trial use Procurement Country Sales channel acceptance acceptance Payer exists at end user process Purchase Routine use 1 2 3 SALES ! 4 5 6 7 . . n • All steps need to be covered in each country before sales can start • Effective building of a
Slide 120: Thank you!
Thank you! Orion Capital Markets Day 2015 26 May 2015 120
Slide 121: R&D pipeline review part II
R&D pipeline review part II Reijo Salonen SVP, Research & Development
Slide 122: Levosimendan for Low Cardiac Output Syndrome
Levosimendan for Low Cardiac Output Syndrome Partner Tenax Therapeutics
Slide 123: Levosimendan development in US by Tenax Therapeutics
Levosimendan development in US by Tenax Therapeutics Development of levosimendan Possibility to include sepsis for Low Cardiac Output shock as an additional Syndrome (LCOS) indication? • Phase 3 LEVO-CTS trial to • Collaboration with Imperial evaluate the efficacy of College London for LeoPARDS levo
Slide 124: LEVO-CTS & LeoPARDS trials
LEVO-CTS & LeoPARDS trials Low Cardiac Output Levosimendan Syndrome I II III LEVO-CTS trial LeoPARDS trial • A Double-Blind, Randomized, • Double-blind randomized placebo Placebo-Controlled Study of controlled LeoPARDS trial to study Levosimendan in Patients with Left the effect of levosimendan in s
Slide 125: Dexmedetomidine for treatment of pain
Dexmedetomidine for treatment of pain Partner Recro Pharma
Slide 126: Dexmedetomidine development for acute post-operative pain by Recro Pharma
Dexmedetomidine development for acute post- operative pain by Recro Pharma Dexmedetomidine (intranasal) Treatment of pain I IIb • Phase II trial to study the effect and safety of intranasal formulation of dexmedetomidine in adult patients undergoing bunionectomy surgery in US • Possibility to avoid
Slide 127: ORM-12741 for Alzheimer's disease
ORM-12741 for Alzheimer’s disease In collaboration with Janssen
Slide 128: ORM-12741
ORM-12741 • Highly potent and selective alpha- 2C adrenoceptor antagonist • Rodent models predict beneficial effects on cognition and neuropsychiatric symptoms (NPS) • Phase 1 studies (healthy subjects) – Possible to administer orally Quality of Memory – Well tolerated – Displacement of an alpha-2C
Slide 129: Phase 2 study on efficacy of ORM-12741 in AD
Phase 2 study on efficacy of ORM-12741 in AD ORM-12741 (alpha-2c adrenoceptor antagonist) Alzheimer’s disease I IIa Improved formulation for the next Phase 2 study • New formulation improving pharmacokinetic (PK) properties of ORM-12741 has been developed • Phase 1 PK studies conducted to confirm qu
Slide 130: ODM-104
So RION Building well-being
Slide 131: Treatment of Parkinson's disease with levodopa
Treatment of Parkinson’s disease with levodopa • Levodopa is the most effective medicine for treating PD • As PD progresses, most people will eventually require the use of levodopa (85% of PD patients receive levodopa) • However, like all medicines, levodopa is not perfect – short acting levodopa ca
Slide 132: New COMT-inhibitor ODM-104 for Parkinson's disease treatment
New COMT-inhibitor ODM-104 for Parkinson’s disease treatment ODM-104 (more effective COMT inhibitor) Parkinson’s disease I • In phase I*, ODM-104 has been in well tolerated and superior to entacapone by improving COMT inhibition and levodopa pharmacokinetics in man • Optimized carbidopa component fu
Slide 133: Increased levodopa exposure reduces OFF-time in PD patients
Increased levodopa exposure1 reduces OFF-time2 in PD patients during different LD/AADCi ± COMTi3 treatments q.i.d – A change from Stalevo4 ODM-104 with COMTi Sinemet5 Stalevo Carbidopa+6 ODM-104 carbidopa+7 Dose mg AUC1 OFF2 AUC OFF AUC OFF AUC OFF11 AUC OFF12 - 0.748 0.89 In PoC 100 1.26 1.20 - 1.3
Slide 134: Target indication
Target indication • The target indication of ODM-104 is Parkinson´s disease with end-of- dose motor fluctuations - the same as the currently approved indications of Comtess®/Comtan® and Stalevo® Levodopa + carbidopa Levodopa + carbidopa + ODM-104 + Comtess® / Comtan® levodopa & (entacapone) carbidop
Slide 135: ODM-106
Target: First/Best-in-class ODM-106 GABA B PAM molecule for the treatment of Essential tremor
Slide 136: Essential Tremor
Essential Tremor • Chronic, slowly progressive postural and/or kinetic tremor, usually affecting both upper extremities – May initially be intermittent and then becomes persistent – May also affect the head, voice, jaw, lips and face – Tremor amplitude is highly variable, worsened by emotion, hunger
Slide 137: Unmet needs in Essential Tremor
Unmet needs in Essential Tremor Approximately 50% fail on current treatments due to efficacy or side-effects • Mainly treated with generic beta-adrenergic blockers (propranolol) and anticonvulsants (primidone) Deep Brain Stimulation (DBS) used for last option for the treatment of severe patients Cur
Slide 138: GABAB PAM
GABAB PAM (gamma-aminobutyric acid B positive allosteric modulator) Positive allosteric modulator: a ligand that binds to a distinct (allosteric) site on the receptor and hereby increases the activity of the endogenous agonist Decrease of GABA activity in several brain areas in essential tremor whic
Slide 139: ODM-106 shows efficacy and safety in Essential tremor
ODM-106 shows efficacy and safety in Essential tremor ODM-106 (GABA-B receptor positive allosteric modulator) Essential tremor I • Alleviates tremor in essential tremor animal model (harmaline –induced tremor) Tremor • No signs of development of tolerance after repeated doses • No sedative or other
Slide 140: ODM-108
Target: ODM-108 Best-in-class TRPA1 antagonist molecule for the treatment of Neuropathic pain
Slide 141: Neuropathic Pain
Neuropathic Pain Caused by a lesion or disease affecting the somatosensory nervous system • Trauma, infection, cancer, anti-cancer treatments, etc. Causes distress and suffering • Very high impact on quality of life • Sleep, enjoyment of life, work and earning are all affected Prevalence 3.3-8.2% 14
Slide 142: Unmet needs in Neuropathic Pain
Unmet needs in Neuropathic Pain High unmet need as currently available treatments only work as monotherapy in < 30% of those treated Treatment options include serotonin-noradrenaline reuptake inhibitors, (duloxetine, venlafaxine) tricyclic antidepressants, pregabalin, gabapentin, opioids, tramadol,
Slide 143: TRPA1 antagonist
TRPA1 antagonist (Transient Receptor Potential Ankyrin 1) TRPA1 receptors are expressed on pain neurons and when activated sends signals of pain in humans Highly competitive target with very difficult chemistry Advantages of TRPA1 antagonist • Robust functional antagonism • High selectivity • Less s
Slide 144: ODM-108 shows efficacy and safety in Neuropathic pain
ODM-108 shows efficacy and safety in Neuropathic pain ODM-108 (negative allosteric modulator of TRPA1 ion channel) Neuropathic pain I • ODM-108 blocks pain in several No pain 32 O D M - 1 0 8 tr e a tm e n t s ta rte d M e c h a n ic a l s e n s itiv ity ( g ) animal models of pain (STZ in figure, S
Slide 145: ODM-109
Target: ODM-109 Best symptomatic treatment for Amyotrophic Lateral Sclerosis (ALS)
Slide 146: Amyotrophic lateral sclerosis - ALS
Amyotrophic lateral sclerosis - ALS • Orphan disease with prevalence of • ~0.4 patients/10,000 • Degeneration of motoneurons leads to skeletal muscle weakness and diaphragm failure • Causes premature death (3 years median survival time from symptom onset) • Decreases Quality of Life of both patient
Slide 147: Data supporting development of ODM-109 for ALS
Data supporting development of ODM-109 for ALS Levosimendan enhances force generation of diaphragm muscle fibers obtained from a rat model of heart failure and from COPD and non-COPD patients (ex vivo experiments) Levosimendan improves human diaphragm function in healthy subjects in vivo Levosimenda
Slide 148: Levosimendan increases calcium sensitivity by binding to troponin C
Levosimendan increases calcium sensitivity by binding selectively to troponin C in cardiac and skeletal muscles Effect/parameter Levosimendan Calcium sensitization (troponin C) + Affects fast muscle fibers + Affects slow muscle fibers + ATP/oxygen sparing effect + Long-acting metabolite + Crossing B
Slide 149: LEVALS study - levosimendan in ALS patients
LEVALS study - levosimendan in ALS patients ODM-109 (oral levosimendan) ALS I II • The first phase II study aims to demonstrate beneficial effects on respiratory function • Double-blind, cross-over design with 3 treatment periods • Cross-over part of the study is followed by an open-label part for 6
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Slide 151: Q&A
Q&A 151 26 May 2015 Orion Capital Markets Day 2015