Orion Oyj Class A · OMXHEX:ORNAV
Orion Oyj Class A — Q1-Q3 2014 Earnings Presentation
48 slides from Orion Oyj Class A's earnings presentation, 2014
Slide 1: Company presentation for investors 2014 Q1-Q3
Company presentation for investors 2014 Q1-Q3
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 Q1-Q3 and Outlook 10 Strategy and financial targets 14 Orion R&D – long term opportunities 28 Proprietary Products and Specialty Products update 35 Key financials 42 General info 3 Investor Presentation 2014 Q1-Q3
Slide 4: Advances in pharmaceutical development projects
Advances in pharmaceutical development projects • Net sales and operating profit include significant milestone payments received from collaboration partners that were higher than in previous year • Good growth in Specialty Products sales • First generic competitors to Precedex entered US markets • R
Slide 5: Key figures
Key figures Basic earnings per Laimentamaton Cash flow perrahavirta Osakekohtainen share Net sales, Operating profit, EUR million EUR million osakekohtainen tulos, € share, EUR before financial ennen items, rahoituseriä, € EUR 734 760 217 202 1.21 1.07 1.34 0.56 Q1-Q3/2013 Q1-Q3/2014 Q1-Q3/2013 Q1-Q
Slide 6: Net sales originate mainly in Europe
Net sales originate mainly in Europe Breakdown of EUR 760 million net sales in Q1-Q3/2014 Q1-Q3/ Sales split by market area Key figures by business divisions 2014 Change % Net sales of Pharmaceuticals, 13% EUR million 721 +4% Proprietary Products 285 -0% 28% Specialty Products 310 +11% 11% Animal He
Slide 7: Best-selling pharmaceuticals Q1-Q3/2014
Best-selling pharmaceuticals Q1-Q3/2014 2013 Net sales, EUR million Stalevo®, Comtess® & Comtan® (Parkinson’s disease) -17% 130 207 Simdax® (acute decompensated heart failure) +5% 35 46 Precedex® (intensive care sedative) -39% 25 59 dexdor® (intensive care sedative) +37% 25 25 Easyhaler® product fam
Slide 8: Product mix is changing
Product mix is changing Sales split by business Sales split by business 2011 Q1-Q3/2014 3% 4% 5% 5% 5% 6% 7% 7% 37% 45% 1 0 Category 1 35% Category 2 Category 3 41% Category 4 Proprietary Products Specialty Products (generics+OTC) Animal Health Fermion Contract Manufacturing & other Orion Diagnostic
Slide 9: Outlook for 2014 (unchanged)
Outlook for 2014 (unchanged) Net sales will be at similar level to 2013 (net sales in Net sales 2013 were EUR 1,007 million) Operating profit will be at similar level to 2013 Operating profit (operating profit in 2013 was EUR 268 million) Group’s capital expenditure will be about EUR 60 million Grou
Slide 10: Orion's strategy and financial targets
Orion’s strategy and financial targets
Slide 11: Profitable growth and increased shareholder value whilst keeping business risks under control
Profitable growth and increased shareholder value whilst keeping business risks under control Partners and networking Efficient and competitive operations MANAGEMENT OF COMPLEXITY IN COST EFFICIENT WAY 11 Investor Presentation 2014 Q1-Q3
Slide 12: Balancing mid-term − building long-term
Balancing mid-term − building long-term Upside potential from pipeline progress Enlargened portfolio in the Nordics Parkinson’s franchise post patent Continued growth in Eastern Europe and Russia Precedex royalty stream post patent Contract Manufacturing Pricing pressure especially on new Easyhaler
Slide 13: Orion's financial objectives
Orion’s financial objectives Operating profit 300 35% Orion’s financial objectives are: 250 30% Operating • Ensuring financial stability 200 25% profit, EUR • Profitable growth 150 20% million 100 15% Operating profit, % of net The objectives are achieved through: 50 10% sales • Increasing net sales
Slide 14: Orion R&D – long term opportunities
Orion R&D – long term opportunities
Slide 15: 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 16: 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 17: 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 18: 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 19: ODM-201 a new generation androgen receptor inhibitor
ODM-201 a new generation androgen receptor (AR) inhibitor for prostate cancer
Slide 20: Partnership with Bayer – Financial terms
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 receive milest
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, alpha-2c adrenoceptor antagonist
ORM-12741, alpha-2c adrenoceptor antagonist
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: Proprietary Products and Specialty Products update
Proprietary Products and Specialty Products update
Slide 29: 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 30: 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 Comtan ROW Generic entacapone Stalevo, Comtess & Comtan Stalevo ROW US
Slide 31: Precedex and dexdor intensive care sedatives
Precedex® and dexdor® intensive care sedatives European sedative market MAT6/2014 Breakdown of Precedex USD million Total market value EUR 485 million (+2.4%) markets 450 400 5% 12% 350 +7% 64 300 60 15% 250 68% 200 +19% 332 150 279 100 50 Propofol EUR 327 million (+4%) 0 Midazolam EUR 74 million (-
Slide 32: Easyhaler for asthma and COPD
Easyhaler® for asthma and COPD 1993 Buventol 1994 Beclomet 2002 Buventol 35 20% Easyhaler® Easyhaler® Easyhaler® 30 15% EUR million (salbutamol) (beclomethasone) (budesonide) 25 10% 20 5% 15 0% 10 -5% 5 -10% 0 -15% 2014 Bufomix 2010 2004 Formoterol Easyhaler® Development of Easyhaler® (budesonide-
Slide 33: 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 34: Launches are basis for future growth in SpP
Launches are basis for future growth in SpP EUR million Specialty Products launches 450 16% Number of product/country combinations 400 14% 160 350 12% 140 300 120 10% 100 250 8% 80 200 60 6% 150 40 4% 100 20 0 50 2% 2006 2007 2008 2009 2010 2011 2012 2013 0 0% 2009 2010 2011 2012 2013 YTD9 SpP launc
Slide 35: Key financials
Key financials — RION Building well-being
Slide 36: Key figures by quarter
Key figures by quarter EUR million Net sales EUR million Operating profit 1,200 300 1,000 250 60 59 53 66 254 273 800 236 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 12 13 14
Slide 37: Key figures for 2010─Q3/2014
Key figures for 2010─Q3/2014 Orion’s key figures 2010 2011 2012 2013 Q1─Q3/2014 Q1─Q3/2013 Change % Net sales, EUR million 849.9 917.9 980.4 1,006.9 760.0 734.3 +3.5% Operating profit, EUR million 254.2 282.9 278.3 267.7 217.2 201.8 +7.6% Profit before taxes, EUR million 252.6 282.0 276.6 264.0 214.
Slide 38: Income Statement 2010─Q3/2014
Income Statement 2010─Q3/2014 Formation of profits, EUR million 2010 2011 2012 2013 Q1─Q3/2014 Q1─Q3/2013 Change % Net sales 849.9 917.9 980.4 1,006.9 760.0 734.3 +3.5% Cost of goods sold -283.2 -305.1 -350.8 -393.5 -295.5 -286.9 +3.0% Gross profit 566.8 612.8 629.6 613.4 464.5 447.4 +3.8% Other ope
Slide 39: Financial position
Financial position EUR million 9/14 9/13 Change% EUR million 9/14 9/13 Change% Non-current assets total 362.7 352.7 +2.8% Inventories 185.2 199.6 -7.2% Equity total 515.6 477.4 +8.0% Interest-bearing non- Trade receivables 164.1 157.9 +3.9% current liabilities 217.5 240.8 -9.7% Non-current liabiliti
Slide 40: 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 Jun09 Mar10 Dec10 Sep11 Jun12 Mar13 Dec13 Sep14 Jun09 Mar10 Dec10 Sep11 Jun12 Mar13 Dec13 Sep14 Receivables Inventories Receivables Short-term non-interest bearing l
Slide 41: 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 42: General info
General info GRION Building well-being
Slide 43: 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 2013 Net sales EUR 1 007 million Operating profit EUR 268 million R&D ex
Slide 44: 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 2013 EUR 64 million (excluding supplies for own use) • Net sales in 2013
Slide 45: 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 45 Investor Presentation 2014 Q
Slide 46: Orion shares are broadly held
Orion shares are broadly held By number of shares on 30 Sep By number of votes on 30 Sep 5% 1% 7% 5% 7% 7% 8% 43% 13% 61% 39% 4% Households Households Non-Finnish holders and nominee registered Non-Finnish holders and nominee registered Private corporations Private corporations Public sector Public
Slide 47: Orion B share performance
Orion B share performance 3 July 2006─ 30 Sep 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 47 Investor Presentation 2014 Q1-Q3
Slide 48: 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