Slide 1: Company presentation for investors 2014 Q1
Company presentation for investors 2014 Q1
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 and Outlook 11 Strategy and financial targets 15 Orion R&D – long term opportunities 33 Proprietary Products and Specialty Products update 41 Key financials 48 General info 3 Investor Presentation 2014 Q1
Slide 4: Results 2014 Q1 & Outlook
Results 2014 Q1 & Outlook
Slide 5: First marketing authorisations in Europe for Bufomix Easyhaler
First marketing authorisations in Europe for Bufomix Easyhaler® • Net sales similar to comparative period • Operating profit slightly lower than in previous year as anticipated • Bufomix Easyhaler® gained first marketing authorisations in Europe • Generic competition to Precedex not yet started in U
Slide 6: Key figures for 2014 Q1
Key figures for 2014 Q1 2014 Q1 2013 Q1 Change % 2013 Net sales, EUR million 245.0 249.4 -1.8% 1 006.9 Operating profit, EUR million 67.4 74.1 -9.1% 267.7 % of net sales 27.5% 29.7% 26.6% R&D expenses, EUR million 26.3 24.6 +6.8% 101.9 % of net sales 10.7% 9.9% 10.1% Basic earnings per share, EUR 0.
Slide 7: Key figures by business areas
Key figures by business areas Key figures for Pharmaceuticals business 2014 Q1 2013 Q1 Change % 2013 Net sales of Pharmaceuticals, EUR million 229.5 234.2 -2.0% 953.0 Proprietary Products 88.2 100.3 -12.1% 390.4 Specialty Products 102.1 95.7 +6.7% 384.9 Animal Health 15.4 14.8 +4.4% 70.8 Fermion 14.
Slide 8: Net sales originate mainly in Europe
Net sales originate mainly in Europe Breakdown of EUR 245 million net sales in 2014 Q1 By business division By market area 7% 3% 13% 6% 29% 36% 6% 12% 14% 42% 32% Proprietary Products Specialty Products Animal Health Finland Scandinavia Fermion Other Europe North America Contract manufacturing & oth
Slide 9: Best-selling pharmaceuticals
Best-selling pharmaceuticals Business Orion’s best-selling pharmaceuticals, EUR million Division Q1/2014 Q1/2013 Change % 2013 1. Stalevo®, Comtess® and Comtan® (Parkinson’s disease) PP 47.2 60.3 -22% 207 2. Simdax® (acute decompensated heart failure) PP 10.7 10.8 -2% 46 3. Precedex® (intensive care
Slide 10: Outlook for 2014
Outlook for 2014 • Net sales will be at similar level to 2013 (net sales in 2013 were EUR 1,007 million) • Operating profit will be slightly lower than in 2013 (operating profit in 2013 was EUR 268 million) • Group’s capital expenditure will be about EUR 60 million excluding substantial corporate or
Slide 11: Orion's strategy and financial targets
Orion’s strategy and financial targets
Slide 12: 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 M ANAGEMENT OF COMPLEXITY IN COST EFFICIENT WAY 12 Investor Presentation 2014 Q1
Slide 13: 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 14: Orion's financial objectives
Orion’s financial objectives Operating profit 300 35% Orion’s financial objectives are: 250 30% Operating • Ensuring financial stability profit, EUR 200 25% • Profitable growth million 150 20% Operating profit, % of net The objectives are achieved through: 100 15% sales • Increasing net sales. Achie
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 Easyhaler® budesonide-formoterol Asthma, COPD I II III Registration Stalevo® for Japanese markets 1) Parkinson’s disease I II III Registration Easyhaler® salmeterol-fluticasone Asthma, COPD I II III ORM-12741 (alp
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: ORM-12741, alpha-2c adrenoceptor antagonist
ORM-12741, alpha-2c adrenoceptor antagonist
Slide 21: 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 22: 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 pts – Patients with
Slide 23: 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 24: 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 25: ODM-201 a new generation androgen receptor (AR) inhibitor for prostate cancer
ODM-201 a new generation androgen receptor (AR) inhibitor for prostate cancer
Slide 26: ODM-201 has a unique profile
ODM-201 has a unique profile ODM-201 + enzalutamide 19%* main metabolite 3% ** ARN-509 29%* Compound AR Antagonism Proliferation affinity WT AR VCaP Ki (nM) IC50 (nM) IC50 (nM) enzalutamide 78 155 400 ARN-509 53 168 300 ODM-201 9 65 500 *Refs. Clegg et al, Cancer Research 2012; Forster at al, Prosta
Slide 27: In ARADES I/II study 12 wk PSA response was most pronounced in Chemo-/CYP17i naive patients
In ARADES I/II study 12 wk PSA response was most pronounced in Chemo-/CYP17i naive patients Chemo-/CYP17i-naïve Post-chemo/CYP17i naïve Post-CYP17i * * * > 50% PSA response rate 100 mg bid 200 mg bid 700 mg bid 86% at 700mg bid *Data truncated at +25% 27 Investor Presentation 2014 Q1
Slide 28: Most common (>10%) adverse events in ARADES study by grade
Most common (>10%) adverse events in ARADES study by grade N of patients (%) Follow-up until week 12 (N=124) Grade 1-2 Grade 3 Grade 4 Fatigue /Asthenia 30 (24%) 1 (1%) - Back pain 17 (14%) 1 (1%) - Constipation 16 (13%) - - Nausea 13 (10%) 1 (1%) - Pain 13 (10% ) 1 (1%) - Decreased appetite 12 (10%
Slide 29: Conclusions from clinical studies and next steps
Conclusions from clinical studies and next steps • ODM-201 is a safe and well • A Phase 3 study in nmCRPC patients tolerated treatment is scheduled to start recruitment in – Adverse events were mostly Q2/2014 mild, and seemed to be related • Patients at high risk for developing to prostate cancer or
Slide 30: ODM-103 and ODM-104 for Parkinson's disease
ODM-103 and ODM-104 for Parkinson’s disease
Slide 31: ODM-103 and -104 for Parkinson's disease
ODM-103 and -104 for Parkinson’s disease ODM-103, more effective COMT-inhibitor Pre-clinical study • Pre-clinical study results indicated that ODM-103 is more effective than entacapone Phase I Safety study ongoing in Europe since summer 2012 ODM-104, more effective COMT-inhibitor Pre-clinical study
Slide 32: Target is to develop the best possible peroral levodopa product
Target is to develop the best possible peroral levodopa product to increase premium for market access - improved efficacy / reduced OFF-time -0.8 hrs -1.5 hrs ? ? -4.5 hrs Off-time Standard Stalevo* levodopa ODM- -4,5 hrs 101** Increased Premium Infusion ODM- 103/104 Possible new levodopa products A
Slide 33: Proprietary Products and Specialty Products update
Proprietary Products and Specialty Products update
Slide 34: 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 35: Turning points of Parkinson's franchise
Turning points of Parkinsons’s franchise 2011 2012 2013 2014 2015 Comtess / Comtan in-market sales EUR 30 million in 2012 Entacapone molecule patent Generic versions of Comtess Europe EUR 20 million in 2013 expired 11/2012 Stalevo in-market sales EUR 252 million in 2012 Start of generic Stalevo data
Slide 36: Rx value shares in USA after generic launches
Rx value shares in USA after generic launches Total Rx value in USA - all entacapone products 100% Wockhardt’s generic Comtan launched in October 80% Sun’s generic Comtan launched in April 60% Generic Stalevo products 46% launched in April 40% 21% 20% 20% 13% 0% Novartis Sun Wockhardt Mylan 36 Inves
Slide 37: Precedex and dexdor intensive care sedatives
Precedex® and dexdor® intensive care sedatives European sedative market 2013 Breakdown of Precedex USD million Total market value EUR 475 million (+0.4%) markets 350 4% 13% 300 60 +4% 250 58 16% 200 67% 150 +22% 266 100 211 50 Propofol EUR 318 million (+2%) 0 Midazolam EUR 75 million (-7%) 2012 2013
Slide 38: Easyhaler for asthma and COPD
Easyhaler® for asthma and COPD 1993 Buventol Easyhaler® 1994 Beclomet Easyhaler® 2002 Buventol Easyhaler® 35 30% (salbutamol) (beclomethasone) (budesonide) 30 25% 20% 25 EUR million 15% 20 10% 15 5% 2004 Formoterol 2014 Bufomix Easyhaler® 2010 Development of Easyhaler® (formoterol) (budesonide-form
Slide 39: 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 40: 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% 140 120 300 10% 100 250 80 8% 200 60 6% 40 150 20 100 4% 0 50 2% 2006 2007 2008 2009 2010 2011 2012 2013 0 0% SpP launches in 2013 2009 2010 2011 201
Slide 41: Key financials
Key financials — RION Building well-being
Slide 42: 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 71 67 600 246 237 Q3 150 Q3 211 213 65 Q2 65 Q2 400 100 60 61 227 233 248 207 Q1 Q1 200 50 93 71 79 74 67 215 244 247 249 245 0 0 10 11 12 13 14 10 11 12 13 1
Slide 43: Key figures for 2010─Q1/2014
Key figures for 2010─Q1/2014 Orion’s key figures 2010 2011 2012 2013 Q1/2014 Q1/2013 Change % Net sales, EUR million 849.9 917.9 980.4 1,006.9 245.0 249.4 -1.8% Operating profit, EUR million 254.2 282.9 278.3 267.7 67.4 74.1 -9.1% Profit before taxes, EUR million 252.6 282.0 276.6 264.0 66.5 73.8 -9
Slide 44: Income Statement 2010─Q1/2014
Income Statement 2010─Q1/2014 Formation of profits, EUR million 2010 2011 2012 2013 Q1/2014 Q1/2013 Change % Net sales 849.9 917.9 980.4 1,006.9 245.0 249.4 -1.8% Cost of goods sold -283.2 -305.1 -350.8 -393.5 -95.8 -91.8 +4.4% Gross profit 566.8 612.8 629.6 613.4 149.2 157.6 -5.3% Other operating i
Slide 45: Financial position
Financial position EUR million 3/14 3/13 Change% EUR million 3/14 3/13 Change% Non-current assets total 354.0 334.2 +5.9% Inventories 198.0 189.2 +4.6% Equity total 392.0 382.4 +2.5% Interest-bearing non- Trade receivables 168.3 164.4 +2.4% current liabilities 229.3 103.4 +121.6% Non-current liabili
Slide 46: 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 -20% -150 Dec08 Sep09 Jun10 Mar11 Dec11 Sep12 Jun13 Mar14 Dec08 Sep09 Jun10 Mar11 Dec11 Sep12 Jun13 Mar14 Receivables Receivables Inventories Inventories Short-term non-interest be
Slide 47: 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 48: General info
General info GRION Building well-being
Slide 49: 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 50: 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 51: 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 51 Investor Presentation 2014 Q
Slide 52: Orion shares are broadly held
Orion shares are broadly held By number of shares on 31 Mar By number of votes on 31 Mar 6% 2% 6% 5% 7% 7% 8% 45% 13% 62% 4% 35% Households Households Non-Finnish holders and nominee registered Non-Finnish holders and nominee registered Private corporations Private corporations Public sector Public
Slide 53: Orion B share performance July 2006─ April 2014
Orion B share performance 3 July 2006─ 17 April 2014 Index 3 July 2006 = 100 250 230 210 190 MSCI Europe Pharmaceuticals 170 150 OMX Helsinki Cap 130 Orion B 110 Orion B total return 90 70 50 53 Investor Presentation 2014 Q1
Slide 54: 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