Orion Oyj Class A · OMXHEX:ORNAV
Orion Oyj Class A — Investor Presentation (June 2016)
69 slides from Orion Oyj Class A's investor presentation, Jun 3, 2016
Slide 1: Orion Investor Presentation
Orion Investor Presentation Updated on 3 June 2016
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 Orion in brief 17 Strategy and financial objectives 23 Key financials 30 R&D – long term opportunities units 58 Business units 3 Investor Presentation (updated on 3 Jun 2016)
Slide 4: Orion in brief
Orion in brief GRION Building well-being
Slide 5: Orion today – building well-being since 1917
Orion today – building well-being since 1917 Specialty Products Animal Health (Gx + OTC) Net sales ~mEUR 1,000 Fermion Personnel ~3,400 (API production) R&D expenses ~11% of net sales Contract Six production sites in Manufacturing Finland Sales organisation in Orion >20 European countries Diagnostic
Slide 6: Steady development despite patent expiries
Steady development despite patent expiries Net sales Operating profit 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 2015 2010 2011 2012 2013 2014 2015 Parkinson's franchise + Precedex Operating
Slide 7: Product mix is changing
Product mix is changing Sales split by business Sales split by business 2011 2015 3% 4% 5% 5% 5% 6% 7% 32% 7% 45% 1 35% 46% 0 Category 1 Category 2 Category 3 Category 4 Proprietary Products Specialty Products (generics+OTC) Animal Health Fermion Contract Manufacturing & other Orion Diagnostica 7 In
Slide 8: Key figures for Q1/2016
Key figures for Q1/2016 Q1/2015 Q1/2016 Q1/2015 Q1/2016 260 262 0.47 0.45 0.38 0.29 83 80 Net sales, EUR Operating profit, Basic earnings per Cash flow per share million EUR million share, EUR before financial items, EUR +1% -3% -4% -23% 8 Investor Presentation (updated on 3 Jun 2016)
Slide 9: Breakdown of net sales
Breakdown of net sales Change Change vs. vs. Sales split by Net sales, EUR million Q1/16 Q1/15 2015 2014 market area in 2015 Pharmaceuticals 249 +2% 961 -0% 14% Proprietary Products 88 -1% 323 -14% 31% 8% Specialty Products 123 +13% 471 +10% Animal Health 18 -16% 77 +10% Fermion 11 -28% 53 -8% 31% C
Slide 10: Best-selling pharmaceuticals
Best-selling pharmaceuticals Net sales Net sales EUR million Change EUR million Product Indication Q1/16 vs. Q1/15 2015 Parkinson’s disease 33 -23% 138 Asthma, COPD 16 +25% 51 Intensive care sedative 14 +28% 45 Acute decompensated 14 +8% 51 heart failure Rheumatoid arthritis, inflammatory bowel 12 +
Slide 11: Key clinical pharmaceutical development projects 1/2
Key clinical pharmaceutical development projects 1/2 Project Indication PHASE Registration Easyhaler® budesonide-formoterol 1) Asthma, COPD I II III Registration Easyhaler® salmeterol-fluticasone Asthma, COPD I II III Prostate cancer ODM-201 (androgen receptor antagonist) 2) (nmCRPC) I II III Prosta
Slide 12: 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 II ODM-203 (targeted FGFR+VEGFR inhibitor) Solid tumours I II ODM-204 (CYP17 enzyme and androgen receptor inhibitor) Prostate cancer I ODM-108 (neg
Slide 13: 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. (Specialty Products) Generic competition for Parkinson’s Easyhaler® combinations and franchise. dexdor® for European markets. Global pricing pressure. O
Slide 14: Two share classes, broad shareholder base
Two share classes, broad shareholder base By number of shares on 31 May By number of votes on 31 May 5% 2% 0% 8% 0% 0% 6% 8% 6% 40% 13% 62% 9% 41% Households (Finnish retail investors) Households (Finnish retail investors) Non-Finnish holders and nominee registered Non-Finnish holders and nominee re
Slide 15: Orion B share performance
Orion B share performance 3 July 2006─31 March 2016 Index 3 July 2006 = 100 400 350 300 250 200 150 100 50 MSCI Europe Pharmaceuticals OMX Helsinki Cap Orion B Orion B total return 15 Investor Presentation (updated on 3 Jun 2016)
Slide 16: From conglomerate to pharmaceuticals and diagnostics company
From conglomerate to pharmaceuticals and diagnostics company Orion listed to Helsinki Stock Exchange Orion in 1990 (sales FIM million) Demerger into 131 98 Orion Oyj and Normet divested Oriola-KD Oyj 217 535 1663 1993 1995 1999 2003 2006 824 Chymos divested Noiro divested Pharmaceuticals Oriola (who
Slide 17: Orion’s strategy and financial objectives
Orion’s strategy and financial objectives
Slide 18: Orion’s strategy – Mission to build well-being
Orion’s strategy – Mission to build well-being 18 Investor Presentation (updated on 3 Jun 2016)
Slide 19: 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%.
Slide 20: Orion’s financial objectives
Orion’s financial objectives Operating profit Net sales 300 35% 1,200 12% 250 30% Operating 1,000 10% 8% profit, EUR 800 200 25% million 6% Net sales, EUR 600 million 150 20% 4% Operating 400 2% profit, % of net Growth, % 100 15% 200 0% sales - -2% 50 10% Operating profit target 0 5% >20% Dividend E
Slide 21: 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 22: Outlook for 2016
Outlook for 2016 Net sales are estimated to be at similar level to 2015 Net sales (net sales were EUR 1,016 million in 2015). Operating profit Operating profit estimated to exceed EUR 240 million. 22 Investor Presentation (updated on 3 Jun 2016)
Slide 23: Key financials
Key financials — RION Building well-being
Slide 24: Key figures by quarter
Key figures by quarter EUR million Net sales EUR million Operating profit 1,200 300 1,000 250 59 55 51 66 254 273 255 262 800 Q4 200 Q4 76 64 59 67 600 246 237 238 239 Q3 150 Q3 Q2 65 86 74 Q2 400 100 61 233 248 277 255 Q1 Q1 200 50 83 79 74 67 80 247 249 245 260 262 0 0 12 13 14 15 16 12 13 14 15 1
Slide 25: Key figures for 2012─YTD3/2016
Key figures for 2012─YTD3/2016 Change % vs. Orion’s key figures 2012 2013 2014 2015 YTD3/2016 YTD3/2015 Net sales, EUR million 980.4 1,006.9 1,015.3 1015.6 262.0 +0.8% Operating profit, EUR million 278.3 267.7 272.4 266.6 80.3 -3.3% Profit before taxes, EUR million 276.6 264.0 267.8 262.3 79.7 -3.7%
Slide 26: Income Statement 2011─2015
Income Statement 2011─2015 Change % Formation of profits, vs. EUR million 2012 2013 2014 2015 YTD3/2016 YTD3/2015 Net sales 980.4 1,006.9 1,015.3 1015.6 262.0 +0.8& Cost of goods sold -350.8 -393.5 -401.7 -405.8 -102.2 +11.9% Gross profit 629.6 613.4 613.6 609.8 159.8 -5.2% Other operating income an
Slide 27: 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 Property, plant and equipment Depreciation, amortisation and impairment 27 Investor Presentation (updated on 3 Jun 2016)
Slide 28: Financial position
Financial position EUR million 3/16 3/15 Change% EUR million 3/16 3/15 Change% Non-current assets total 370.5 248.5 +6.3% Inventories 207.7 186.4 +11.4% Equity total 475.1 401.8 +18.2% Interest-bearing non- Trade receivables 184.9 171.5 +7.8% current liabilities 175.7 206.1 -14.7% Non-current liabil
Slide 29: Development of Net working capital
Development of Net working capital % of net sales EUR million 35% 250 25% 150 15% 50 5% -50 -5% -150 -15% -25% -250 2011 2012 2013 2014 2015 2016 2011 2012 2013 2014 2015 2016 Receivables Receivables Inventories Inventories Short-term non-interest bearing liabilities Short-term non-interest bearing
Slide 30: Orion R&D – long term opportunities
Orion R&D – long term opportunities
Slide 31: Orion’s R&D strategy
Orion’s R&D strategy Focus on three core therapy areas Focused therapy • Central nervous system diseases areas • Oncology and critical care • Easyhaler pulmonary drugs Emphasis on collaboration and partnerships • Clinical studies are performed globally, Orion’s focus on Europe Shared risks and • Par
Slide 32: Collaborative networks across the R&D value chain
Collaborative networks across the R&D value chain Late stage Research Early development development Candidate Target Hit to Lead Lead selection, identification Phase I Phase II Phase III generation optimisation preclinical and validation development Early stage partnering Late stage partnering KEY C
Slide 33: ODM-201
A novel second generation ODM-201 androgen receptor (AR) antagonist for the treatment of prostate cancer In collaboration with Bayer
Slide 34: 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 35: 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 36: ODM-201: Phase III study ongoing in nmCRPC
ODM-201: Phase III study ongoing in non-metastatic castration resistant prostate cancer (nmCRPC) ODM-201 (androgen receptor antagonist) 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
Slide 37: ODM-201: Phase III study initiating in mHSPC
ODM-201: Phase III study initiating in metastatic hormone sensitive prostate cancer (mHSPC) Prostate cancer ODM-201 (androgen receptor antagonist) 2) (mHSPC) I II • ARASENS is a randomized, double-blind, placebo-controlled multicenter study that is planned to be initiated towards the end of 2016 • A
Slide 38: ODM-203
A unique and selective dual ODM-203 FGFR+VEGFR inhibitor for FGFR-dependent tumors
Slide 39: 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 40: 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 41: ODM-204
Target: ODM-204 Best-in-class treatment for metastatic Castration Resistant Prostate Cancer (mCRPC)
Slide 42: Positioning of ODM-204
Positioning of ODM-204 CRPC AR F876L Post Xtandi / Zytiga AR-V7 Non- Pre-Chemo Post-Chemo metastatic Metastatic Metastatic Metastatic Zytiga Zytiga Xtandi Xtandi ODM-201 ODM-204 Note: Zytiga/Xtandi combination trials are ongoing 42 Investor Presentation (updated on 3 Jun 2016) http://www.orion.fi/en
Slide 43: 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
Slide 44: ORM-12741 for Alzheimer’s disease
ORM-12741 for Alzheimer’s disease In collaboration with Janssen
Slide 45: 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 46: ORM-12741 results
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 47: 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 current Phase 2 study • New formulation improving pharmacokinetic (PK) properties of ORM-12741 has been developed • Phase 1 PK studies conducted to confirm
Slide 48: ODM-104
So RION Building well-being
Slide 49: 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 II • 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
Slide 50: ODM-108
Target: ODM-108 Best-in-class TRPA1 antagonist molecule for the treatment of Neuropathic pain
Slide 51: 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 52: ODM-109
Target: ODM-109 Best symptomatic treatment for Amyotrophic Lateral Sclerosis (ALS)
Slide 53: 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
Slide 54: Levosimendan for Low Cardiac Output Syndrome
Levosimendan for Low Cardiac Output Syndrome Partner Tenax Therapeutics
Slide 55: Levosimendan development in US by Tenax Therapeutics
Levosimendan development in US by Tenax Therapeutics Low Cardiac Output Levosimendan Syndrome I II III 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 evaluat
Slide 56: Dexmedetomidine for treatment of pain
Dexmedetomidine for treatment of pain Partner Recro Pharma
Slide 57: 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 58: Business units
Business units GRION Building well-being
Slide 59: Proprietary products
Proprietary products Sales, EUR million • Mainly Orion in-house developed 450 prescription drugs with valid 400 Other product protect • Global partner network in sales 350 Stalevo and R&D 300 Current main drivers Comtan/Comtess 250 Generic competition for Stalevo, 200 Precedex Comtan/Comtess 150
Slide 60: Parkinson’s drugs
Parkinson’s drugs 60 Market shares of Orion’s branded Parkinson’s drugs 2015 2014 50 Finland 1) 14% 20% 40 Sweden 1) EUR million 9% 14% 30 Norway 1) 15% 15% Denmark 1) 7% 13% 20 Germany 2) 9% 13% 10 UK 2) 12% 12% 0 United States 2) 3) 2% 2% Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 2013 2014 2015 16 Ja
Slide 61: Easyhaler® for asthma and COPD
Easyhaler® for asthma and COPD Easyhaler products = Orion invented inhaler + generic APIs 1994 Beclomet 2002 Budesonide 1993 Buventol Easyhaler® 18 Easyhaler® Easyhaler® (beclomethasone) (budesonide) 16 (salbutamol) 14 12 EUR million 10 8 6 2014 Bufomix 2010 4 2004 Formoterol Easyhaler® Development
Slide 62: dexdor® intensive care sedative
dexdor® intensive care sedative European sedative market MAT12/2016* Dexdor sales Total market value EUR 525 million (+5%) 16 12% 14 7% 12 10 EUR million 14% 8 66% 6 4 Propofol EUR 347 million (+3%) 2 Midazolam EUR 76 million (+0%) 0 Dexmedetomidine EUR 36 million (+30%) Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q
Slide 63: Steady sales growth for Specialty Products
Steady sales growth for Specialty Products Orion Specialty Products = Gx + OTC including also non-medicinal products Geographical sales split in 2015 – 500 20% Finland, Scandinavia & EE key 450 18% markets 400 16% 350 14% 7% EUR million 7% 300 12% 250 10% 11% 200 8% 59 % 150 6% 16% 100 4% 50 2% 0 0%
Slide 64: Specialty Products growing strongly in Scandinavia
Specialty Products growing strongly in Scandinavia Net sales in core market areas Net sales Change in 1-3/2016 (EUR million) 1-3/2016 vs. TOP 3 Products EUR million 1-3/2015 Vs. Scandinavia 12 +319% 1-3/15 21 +44% 5 +3% Vs. Finland 5 -7% 1-3/15 70 +8% Eastern Vs. Europe & 1-3/15 Russia 12 +6% 64 Inv
Slide 65: Orion Pharma Animal Health
Orion Pharma Animal Health 90 12% 75 10% EUR million 60 8% 6% 45 4% 30 2% 15 0% 0 -2% 2011 2012 2013 2014 2015 Net sales Growth, % Product portfolio • Medicinal and non-medicinal products for companion animals and livestock Orion Pharma Animal Health direct sales • In-house developed proprietary pro
Slide 66: Fermion has strategic importance
Fermion has strategic importance 70 40% 60 Fermion develops, manufactures and sells 30% active pharmaceutical ingredients (APIs) 50 EUR million 20% 40 Business segments: 10% 30 • NCEs for Orion’s existing and new proprietary 20 0% products 10 -10% • Generics to Orion and other pharmaceutical compani
Slide 67: Contract manufacturing & other
Contract manufacturing & other 50 45% • Pharmaceutical manufacturing for other 40 30% pharma companies • Supply to global markets EUR million 30 15% • Orion has special know-how 20 0% ie. in hormonal semi-solids and solutions 10 -15% 0 -30% Read more 2011 2012 2013 2014 2015 http://www.orion.fi/en/c
Slide 68: Orion Diagnostica
Orion Diagnostica • Diagnostic test systems for 70 10% point-of-care testing in 60 8% healthcare and hygiene testing 50 for industry 6% EUR million 40 • Main market areas: Europe 4% (especially northern), China, 30 USA, Japan 2% 20 • Own sales units in 9 European 10 0% countries, distributor network
Slide 69: 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