Slide 1: Company presentation for investors Q1 2015
Company presentation for investors Q1 2015
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 Q115 and Outlook 2015 11 Strategy and financial objectives 16 Orion R&D – long term opportunities 31 Proprietary Products and Specialty Products update 39 Key financials 45 General info 3 Investor Presentation Q1 2015
Slide 4: Year started strongly
Year started strongly • Net sales were slightly higher and operating profit clearly higher than in comparative period • Generic competition to Stalevo started to extend in Europe, but Proprietary Products sales as a whole remained steady due to strong growth in sales of the Easyhaler product family
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 83 260 245 0,47 67 0,38 0,37 0.30 Q1/2014 Q1/2015 Q1/2014 Q1/2015 Q1/2014
Slide 6: Net sales originate mainly in Europe
Net sales originate mainly in Europe Breakdown of EUR 260 million net sales in Q1 2015 Sales split by market area Key figures by business divisions Q1_2015 Change % Net sales of Pharmaceuticals, 15 % EUR million 244 +7% Proprietary Products 89 +1% 30 % 8% Specialty Products 109 +6% Animal Health 22
Slide 7: Best-selling pharmaceuticals Q1/2015
Best-selling pharmaceuticals Q1/2015 2014 Net sales, EUR million Stalevo®, Comtess® & Comtan® (Parkinson’s disease) -18% 42 -10% 169 Simdax® (acute decompensated heart failure) +2% 13 +19% 47 Easyhaler® product family (asthma, COPD) +22% 12 +59% 35 dexdor® (intensive care sedative) +39% 11 +40% 35 D
Slide 8: Product mix is changing
Product mix is changing Sales split by business Sales split by business 2011 Q1/2015 3% 4% 5% 5% 6% 6% 7% 36% 45% 8% 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
Slide 9: Capex normalising after investment program
Capex normalising after investment program EUR million Orion Capex 100 80 60 40 20 0 2007 2008 2009 2010 2011 2012 2013 2014 2015* Intangible assets *) Estimate for 2015 Property, plant and equipment Depreciation, amortisation and impairment 9 Investor Presentation Q1 2015
Slide 10: Outlook for 2015 (updated on 24 April 2015)
Outlook for 2015 (updated on 24 April 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 230 million. The Group’s capital expenditure will be about EUR 50 Group’s capital million exclu
Slide 11: Orion's strategy and financial targets
Orion’s strategy and financial targets
Slide 12: Orion's strategy – Mission to build well-being
Orion’s strategy – Mission to build well-being Megatrends Strategic targets Focus areas Strategic development projects 12 Investor Presentation Q1 2015
Slide 13: 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 14: Orion's financial objectives
Orion’s financial objectives Operating profit Net sales 300 35% 1 200 12% 250 30% 1 000 10% Operating 800 8% 200 25% profit, EUR 600 6% Net sales, EUR 150 20% million 400 4% million Operating 200 2% 100 15% - 0% Growth, % profit, % of net 50 10% sales 0 5% Operating profit target >20% Dividend EUR 1
Slide 15: 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 16: Orion R&D – long term opportunities
Orion R&D – long term opportunities
Slide 17: 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 18: 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 19: Key clinical pharmaceutical development projects 1/2
Key clinical pharmaceutical development projects 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
Slide 20: Key clinical pharmaceutical development projects 2/2
Key clinical pharmaceutical development projects 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 re
Slide 21: 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 22: 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 23: 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 24: 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 25: 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 26: 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 27: 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 28: 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 29: ODM-108 and ODM-109
ODM-108 and ODM-109 ODM-108 is a novel, highly potent, ODM-109 is orally administered selective and reversible negative levosimendan, a troponin C selective allosteric modulator of Transient calcium sensitizer enhancing cardiac Receptor Potential A1 (TRPA1) ion and skeletal muscle function. channel
Slide 30: 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 31: Proprietary Products and Specialty Products update
Proprietary Products and Specialty Products update
Slide 32: 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 33: 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 Comtan USA Stalevo USA Comtess/Comtan Europe Stalevo Europe Comtan Japan Stalevo Japan Generic entacapone Stalevo, Comtess & Comtan Comtan ROW
Slide 34: dexdor intensive care sedative
dexdor® intensive care sedative European sedative market MAT12/2014* Dexdor sales Total market value EUR 509 million (+3%) 12 6% 12% 10 8 15% 6 67% 4 2 0 Propofol EUR 342 million (+3%) Midazolam EUR 76 million (-3%) Dexmedetomidine EUR 28 million (+28%) Remifentanil EUR 63 million (+4%) Dexdor sales
Slide 35: Easyhaler for asthma and COPD
Easyhaler® for asthma and COPD 1993 Buventol 1994 Beclomet 2002 Budesonide 40 60% Easyhaler® Easyhaler® Easyhaler® EUR million (salbutamol) (beclomethasone) (budesonide) 30 40% 20 20% 10 0% 0 -20% 2014 Bufomix 2010 2004 Formoterol Easyhaler® Development of Easyhaler® (budesonide- fluticasone- (form
Slide 36: 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 3 000 000 100 000 90 000 2 500 000 80 000 70 000 2 000 000 60 000 1 500 000 50 000 40 000 1 000 000 30 000 20 000 500 000 10 000 0 0 20042005200620072008200920102011201220132014 2004200520062
Slide 37: 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% 140 300 12% 120 250 10% 100 80 200 8% 60 150 6% 40 100 4% 20 50 2% 0 0 0% SpP launches in 2014 By geographic area Eastern Europe 26 Sales Growth% Sca
Slide 38: Key financials
Key financials — RION Building well-being
Slide 39: 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 66 254 273 255 800 236 Q4 200 65 Q4 76 64 67 600 246 237 238 Q3 150 Q3 211 Q2 65 Q2 65 61 86 400 277 100 227 233 248 Q1 Q1 200 50 93 83 79 74 67 244 247 249 245 260 0 0 11 12 13 14 15 11 12 13 14 1
Slide 40: Key figures for 2011─Q1/2015
Key figures for 2011─Q1/2015 Orion’s key figures 2011 2012 2013 2014 Q1/2015 Q1/2014 Change % Net sales, EUR million 917.9 980.4 1,006.9 1,015.3 259.9 245.0 +6.1% Operating profit, EUR million 282.9 278.3 267.7 272.4 83.1 67.4 +23.3% Profit before taxes, EUR million 282.0 276.6 264.0 267.8 82.7 66.5
Slide 41: Income Statement 2011─Q1/2015
Income Statement 2011─Q1/2015 Formation of profits, EUR million 2011 2012 2013 2014 Q1/2015 Q1/2014 Change % Net sales 917.9 980.4 1,006.9 1,015.3 259.9 245.0 +6.1% Cost of goods sold -305.1 -350.8 -393.5 -401.7 -91.4 -95.8 -4.6% Gross profit 612.8 629.6 613.4 613.6 168.5 149.2 +13.0% Other operatin
Slide 42: Financial position
Financial position EUR million 3/15 3/14 Change% EUR million 3/15 3/14 Change% Non-current assets total 348.5 354.0 -1.5% Inventories 186.4 198.0 -5.8% Equity total 401.8 392.09 +2.5% Interest-bearing non- Trade receivables 171.5 168.3 +1.9% current liabilities 206.1 229.3 -10.1% Non-current liabili
Slide 43: 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 Dec09 Sep10 Jun11 Mar12 Dec12 Sep13 Jun14 Mar15 Dec09 Sep10 Jun11 Mar12 Dec12 Sep13 Jun14 Mar15 Receivables Inventories Receivables Short-term non-interest bearing l
Slide 44: 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 45: General info
General info GRION Building well-being
Slide 46: 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 47: 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 48: 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 48 Investor Presentation Q1 201
Slide 49: Orion shares are broadly held
Orion shares are broadly held By number of shares on 31 Mar By number of votes on 31 Mar 5% 2% 8% 0% 5% 8% 6% 43% 13% 63% 8% 39% Households Households Non-Finnish holders and nominee registered Non-Finnish holders and nominee registered Private corporations Private corporations Public sector Public
Slide 50: Orion B share performance
Orion B share performance 3 July 2006─ 31 Mar 2015 Index 3 July 2006 = 100 350 300 250 MSCI Europe Pharmaceuticals 200 OMX Helsinki Cap Orion B 150 Orion B total return 100 50 50 Investor Presentation Q1 2015
Slide 51: 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