Slide 1: Company presentation for investors FY 2014
Company presentation for investors FY 2014
Slide 2: Forward-looking statements
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 anticipa
Slide 3: Contents
Contents 4 Results 2014 and Outlook 2015 10 Strategy and financial objectives 15 Orion R&D – long term opportunities 29 Proprietary Products and Specialty Products update 36 Key financials 43 General info 3 Investor Presentation FY2014
Slide 4: Good year in pharmaceutical development and commercialisation projects
Good year in pharmaceutical development and commercialisation projects • Marketing authorisations for Bufomix Easyhaler in Europe and Stalevo in Japan • Worldwide collaboration with Bayer on ODM-201 development and commercialisation • Early phase clinical development pipeline boosted • Specialty Pro
Slide 5: Key figures
Key figures Basic earnings per Laimentamaton Cash flow perrahavirta share Net sales, Operating profit, Osakekohtainen EUR million EUR million osakekohtainen tulos, € share, EUR before financial ennen items, rahoituseriä, € EUR 1,007 1,015 268 272 1.46 1.50 1.72 1.02 2013 2014 2013 2014 2013 2014 201
Slide 6: Net sales originate mainly in Europe
Net sales originate mainly in Europe Breakdown of EUR 1,015 million net sales in 2014 Sales split by market area Key figures by business divisions 2014 Change % Net sales of Pharmaceuticals, 13% EUR million 962 +1% 29% Proprietary Products 373 -4% 10% Specialty Products 427 +11% Animal Health 70 -1%
Slide 7: Best-selling pharmaceuticals 2014
Best-selling pharmaceuticals 2014 2013 Net sales, EUR million Stalevo®, Comtess® & Comtan® (Parkinson’s disease) -18% 169 207 Simdax® (acute decompensated heart failure) +2% 47 46 Easyhaler® product family (asthma, COPD) +22% 35 29 dexdor® (intensive care sedative) +39% 35 25 Precedex® (intensive ca
Slide 8: Product mix is changing
Product mix is changing Sales split by business Sales split by business 2011 2014 3% 3% 5% 5% 6% 5% 7% 7% 37% 45% 1 35% 42% 0 Category 1 Category 2 Category 3 Category 4 Proprietary Products Specialty Products (generics+OTC) Animal Health Fermion Contract Manufacturing & other Orion Diagnostica 8 In
Slide 9: Outlook for 2015
Outlook for 2015 Net sales will be slightly lower than in 2014 (net sales Net sales were EUR 1,015 million in 2014). Operating profit Operating profit is estimated to exceed EUR 200 million. The Group’s capital expenditure will be about EUR 50 Group’s capital million excluding substantial corporate
Slide 10: Orion's strategy and financial targets
Orion’s strategy and financial targets
Slide 11: Orion's strategy – Mission to build well-being
Orion’s strategy – Mission to build well-being Megatrends Strategic targets Focus areas Strategic development projects 11 Investor Presentation FY2014
Slide 12: 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 13: Orion's financial objectives
Orion’s financial objectives Operating profit Net sales 300 35% 1,200 12% 250 30% Operating 1,000 10% profit, EUR 800 8% 200 25% million Net sales, EUR 600 6% million 150 20% Operating 400 4% profit, % of net Growth, % 100 15% 200 2% sales - 0% 50 10% Operating profit target 0 5% >20% Dividend EUR 1
Slide 14: 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 15: Orion R&D – long term opportunities
Orion R&D – long term opportunities
Slide 16: Orion's R&D strategy
Orion’s R&D strategy Increased productivity R&D operational model renewed in 2009 Focus on three core therapy areas + generics • Central nervous system diseases Focused therapy areas • Oncology and critical care • Easyhaler pulmonary drugs Emphasis on collaboration and partnerships • Clinical studie
Slide 17: 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 18: Key clinical pharmaceutical development projects
Key clinical pharmaceutical development projects 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 Levo
Slide 19: Research projects 2013 (16)
Research projects 2013 (16) HIT Finding Active-To-Hit Hit-To-Lead Lead Optimization Oncology A Oncology B Oncology C Oncology D CNS A CNS B CNS C CNS D CNS E CNS F CNS G CNS H CNS I CNS J CNS H Super generic Collaboration (Biologic) for new indication Precandidate Candidate CTA Snapshot of Orion’s p
Slide 20: ODM-201: Partnership with Bayer – Financial terms
ODM-201: Partnership with Bayer – Financial terms • Orion and Bayer will jointly develop ODM-201, with Bayer contributing a major share of the costs of future development • Bayer will commercialize ODM-201 globally and Orion has the option to co-promote ODM-201 in Europe • Orion is eligible to recei
Slide 21: ODM-201 has a unique profile
ODM-201 + ODM-201 has a unique profile enzalutamide 19%* main metabolite 3% ** ARN-509 29%* Compound AR Antagonism Proliferation affinity WT AR VCaP Ki (nM) IC50 (nM) IC50 (nM) • No brain entry enzalutamide 78 155 400 • No CYP inhibition or induction expected ARN-509 53 168 300 with therapeutic dose
Slide 22: ODM-201: Phase 3 study ongoing
ODM-201: Phase 3 study ongoing • Phase 3 study in non-metastatic castration resistant prostate cancer (nm-CRPC) patients who are at high risk for developing metastatic disease • Primary endpoint – ODM-201 over placebo in metastasis-free survival (MFS) • Secondary endpoints – Overall survival, time t
Slide 23: ORM-12741 – collaboration with Janssen
ORM-12741 – collaboration with Janssen • Licence agreement announced on 19 December 2013 (includes ORM-12741 and other compounds) • Orion received USD 31 million upfront payment which will mainly be used against additional Phase IIa study costs • Orion is eligible to receive milestone payments from
Slide 24: ORM-12741, first Phase 2a Study in AD
ORM-12741, first Phase 2a Study in AD • Objective – To evaluate safety and efficacy of ORM-12741 in treatment of cognitive and behavioral symptoms of Alzheimer’s disease • Design and Methodology – Randomised, double-blind, placebo-controlled, parallel-group Phase 2a study in 100 patients – Patients
Slide 25: ORM-12741 first Phase 2a Study ─ Conclusions
ORM-12741 first Phase 2a Study ─ Conclusions • Clear positive effects on memory measures on active treatment groups as compared to placebo – Clear and statistically significant positive treatment effect on Quality of Episodic Memory (*p=0.03) – Clear and statistically significant positive treatment
Slide 26: ORM-12741 ─ Next Steps
ORM-12741 ─ Next Steps • A new formulation study followed by • An additional Phase 2a in AD patients focusing on – Confirmation of the first Phase 2a results – especially on NPI – Dosing • Development options for Phase 3 Cognition Pros’: Several compound shown to work, clear study designs, endpoin
Slide 27: ODM-104 and ODM-106
ODM-104 and ODM-106 ODM-104 is a new molecule that ODM-106 is an investigational GABA- enhance the therapeutic effects of B positive allosteric modulator (PAM) levodopa used to treat Parkinson’s that enhances the effect of the disease by blocking the COMT naturally occurring agonist GABA, enzyme. Th
Slide 28: ODM-203 and ODM-204
ODM-203 and ODM-204 ODM-203 is an investigational ODM-204 is a unique, investigational targeted Fibroblast Growth Factor dual inhibitor of CYP17 enzyme and Receptor (FGFR) + Vascular androgen receptor (AR) designed to Endothelial Growth Factor Receptor block the growth of castration- (VEGFR) inhibit
Slide 29: Proprietary Products and Specialty Products update
Proprietary Products and Specialty Products update
Slide 30: Product protection situation of key products
Product protection situation of key products Key patents or data protection expire Molecule Product Indication Europe USA Japan Stalevo®, November 2012 January Entacapone Parkinson’s disease October 2013 Comtess® and Comtan® October 2013 1) 2015 2) Acute Levosimendan Simdax® decompensated September
Slide 31: 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 Comtan Japan Comtan ROW Generic entacapone Stalevo, Comtess & C
Slide 32: Precedex and dexdor intensive care sedatives
Precedex® and dexdor® intensive care sedatives European sedative market MAT9/2014 Breakdown of Precedex USD million Total market value EUR 490 million (+3%) markets 450 400 5% 13% 66 350 +9% 60 300 15% 250 67% 200 +10% 335 150 305 100 50 Propofol EUR 330 million (+4%) 0 Midazolam EUR 74 million (-3%
Slide 33: Easyhaler for asthma and COPD
Easyhaler® for asthma and COPD 1993 Buventol 1994 Beclomet 2002 Buventol 40 45% Easyhaler® Easyhaler® Easyhaler® (salbutamol) (beclomethasone) (budesonide) EUR million 30 30% 20 15% 10 0% 0 -15% 2014 Bufomix 2010 2004 Formoterol Easyhaler® Development of Easyhaler® (budesonide- fluticasone- (formot
Slide 34: Retail sales of inhaled respiratory drugs market in Top 5 Europe
Retail sales of inhaled respiratory drugs market in Top 5 Europe EUR (1,000) In value Units (1,000) In units 3,000,000 90,000 80,000 2,500,000 70,000 2,000,000 60,000 50,000 1,500,000 40,000 1,000,000 30,000 20,000 500,000 10,000 0 0 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2004 2005 2006 2
Slide 35: Launches are basis for future growth in SpP
Launches are basis for future growth in SpP EUR million Specialty Products launches 450 18% Number of product/country combinations 400 16% 160 350 14% 140 120 300 12% 100 250 10% 80 60 200 8% 40 150 6% 20 0 100 4% 50 2% 0 0% SpP launches in 2014 2009 2010 2011 2012 2013 2014 By geographic area Easte
Slide 36: Key financials
Key financials — RION Building well-being
Slide 37: Key figures by quarter
Key figures by quarter EUR million Net sales EUR million Operating profit 1,200 300 1,000 250 60 59 55 53 66 254 273 255 800 236 Q4 200 65 Q4 215 76 64 71 67 600 246 237 238 Q3 150 Q3 211 213 65 Q2 65 86 Q2 400 100 60 61 227 233 248 277 207 Q1 Q1 200 50 93 71 79 74 67 215 244 247 249 245 0 0 10 11 1
Slide 38: Key figures for 2010─2014
Key figures for 2010─2014 Orion’s key figures 2010 2011 2012 2013 2014 Change % Net sales, EUR million 849.9 917.9 980.4 1,006.9 1,015.3 +0.8% Operating profit, EUR million 254.2 282.9 278.3 267.7 272.4 +1.8% Profit before taxes, EUR million 252.6 282.0 276.6 264.0 267.8 +1.4% R&D expenses, EUR mill
Slide 39: Income Statement 2010─2014
Income Statement 2010─2014 Formation of profits, EUR million 2010 2011 2012 2013 2014 Change % Net sales 849.9 917.9 980.4 1,006.9 1,015.3 +0.8% Cost of goods sold -283.2 -305.1 -350.8 -393.5 -401.7 +2.1% Gross profit 566.8 612.8 629.6 613.4 613.6 Other operating income and expenses 1.2 3.0 6.3 5.6
Slide 40: Financial position
Financial position EUR million 12/14 12/13 Change% EUR million 12/14 12/13 Change% Non-current assets total 349.1 349.2 Inventories 178.7 195.5 -8.6% Equity total 514.9 513.9 +0.2% Interest-bearing non- Trade receivables 174.0 169.9 +2.4% current liabilities 210.0 233.3 -10.0% Non-current liabilitie
Slide 41: Development of Net working capital
Development of Net working capital % of net sales EUR million 40% 300 250 30% 200 20% 150 100 10% 50 0 0% -50 -10% -100 -150 -20% -200 Sep09 Jun10 Mar11 Dec11 Sep12 Jun13 Mar14 Dec14 Sep09 Jun10 Mar11 Dec11 Sep12 Jun13 Mar14 Dec14 Receivables Inventories Receivables Short-term non-interest bearing l
Slide 42: Dividend distribution policy
Dividend distribution policy Orion’s dividend distribution takes into account distributable funds and capital expenditure and other financial requirements in medium and long term to achieve the financial objectives. Dividend distribution history EUR 1.60 100% 0.12 EUR 1.40 0.06 95% EUR 1.20 0.10 90%
Slide 43: General info
General info GRION Building well-being
Slide 44: Building well-being since 1917
Building well-being since 1917 Orion is an innovative, European, R&D-based, pharmaceutical and diagnostic company with a special emphasis on developing medicinal treatments and diagnostic tests for global markets Orion in brief 2014 Net sales EUR 1 015 million Operating profit EUR 272 million R&D ex
Slide 45: Business units
Business units Proprietary Products Fermion • Patented prescription drugs • Active pharmaceutical ingredients • CTAs: CNS, oncology & critical (API’s) for Orion and other companies care, Easyhaler pulmonary drugs • Net sales in 2014 EUR 57 million (excluding supplies for own use) • Net sales in 2014
Slide 46: Market position strengthened in Europe
Market position strengthened in Europe Finland Market leader Scandinavia Strong domestic market position Eastern Europe Generics Western and Central Europe Strong position with proprietary products Southern Europe Progress with proprietary products in hospital markets 46 Investor Presentation FY2014
Slide 47: Orion shares are broadly held
Orion shares are broadly held By number of shares on 31 Dec By number of votes on 31 Dec 5% 1% 8% 0% 5% 8% 6% 43% 13% 63% 8% 40% Households Households Non-Finnish holders and nominee registered Non-Finnish holders and nominee registered Private corporations Private corporations Public sector Public
Slide 48: Orion B share performance
Orion B share performance 3 July 2006─ 31 Dec 2014 Index 3 July 2006 = 100 350 300 250 MSCI Europe Pharmaceuticals 200 OMX Helsinki Cap Orion B 150 Orion B total return 100 50 48 Investor Presentation FY2014
Slide 49: Orion Investor Relations
Jari Karlson CFO jari.karlson@orion.fi +358 10 426 2883 Orion Investor Tuukka Hirvonen Communications Manager Relations Financial Communications & Investor Relations tuukka.hirvonen@orion.fi +358 10 426 2721 Heidi Ahti Executive Assistant (Investor meeting requests) heidi.ahti@orion.fi +358 10 426 2