Orion Oyj Class A · OMXHEX:ORNAV
Orion Oyj Class A — Investor Day (November 2007)
43 slides from Orion Oyj Class A's investor day presentation, Nov 21, 2007
Slide 1: Capital Markets Day / Agenda
Capital Markets Day 21 November 2007 Grocers’ Hall, London Capital Markets Day, London 21 November 2007 1 Agenda for the Capital Markets Day 21 November 2007, London Time Topic Presenter 8:30 Morning coffee 9:00 Overview on Orion Jukka Viinanen President and CEO 9:30 Specialty Products business Mark
Slide 2: Overview on Orion and highlights of the strategy
Overview on Orion and highlights of the strategy – Building European presence London, 21 November 2007 Jukka Viinanen, CEO Capital Markets Day, London 21 November 2007 3 This presentation includes forward-looking statements (statements that are not historical facts and relate to the future activitie
Slide 3: Orion's Vision / Orion Group structure
Orion’s Vision “Orion is a European R&D based, business-driven pharmaceuticals and diagnostics company with special emphasis on developing innovative treatments and diagnostic tests for global markets” Capital Markets Day, London 21 November 2007 5 Orion Group structure – segments and business divis
Slide 4: Ownership base / Building European presence
Ownership base on 31 October 2007 By number of shares By number of votes Banks and Banks and Foreign held insurance Non-profit insurance and nominee companies organisations companies registered 6% 3% 4% Private 6% Households Non-profit corporations organisations 46% Households 8% 8% 58% Public secto
Slide 5: Breakdown of net sales / Orion's top 10 pharma brands
Breakdown of net sales By geographic segments By sales network Other markets 9% Orion in Finland Partners Finland 29% 28% 29% North America 13% Scandinavia Orion in Other Europe 14% other countries 35% 43% Net sales Q1–Q3/2007 EUR 509.6 million Capital Markets Day, London 21 November 2007 9 Orion’s
Slide 6: Orion's current presence in Europe / Partnerships
Orion’s current presence in Europe • Own sales operations in 17 countries • Sales areas and rounded number of sales personnel: – Finland 130 – Scandinavia 120 – UK and Ireland 40 – Germany and Switzerland 140 – Eastern Europe 140 • R&D and manufacturing mainly in Finland • Orion works with partners
Slide 7: Key financials
Key financials Capital Markets Day, London 21 November 2007 13 Key figures 2004–Q3/2007 2004 2005 2006 Change Q1–Q3/07 Proforma Proforma Proforma % Net sales, EUR million 553.0 585.6 641.1 +9.5% 509.6 Operating profit (EBIT), EUR million 105.3 155.2 196.7 +26.7% 154.9 % of net sales 19.0% 26.5% 30.7
Slide 8: Outlook for 2007 / Financial objectives and dividend policy
Outlook for 2007 • Net sales – Net sales will grow slightly from those of 2006. – Sales of pharmaceuticals via Orion’s own sales network will grow moderately in Finland and the markets outside Finland will continue showing growth. – In-market sales of Parkinson’s disease medicines will continue show
Slide 9: Orion's calendar for investors
Orion’s calendar for investors Result for 2007 Thu 7 February 2008 Interim Report Q1/2008 Fri 25 April 2008 Interim Report Q1–Q2/2008 Tue 5 August 2008 Interim Report Q1–Q3/2008 Tue 28 October 2008 Annual Report 2007 will be published during week 10/2008 The Annual General Meeting is planned to be h
Slide 10: Total pharmaceutical market forecast
Specialty Products Business London, 21 November 2007 Markku Huhta-Koivisto, SVP, Speciality Products and Fermion Capital Markets Day, London 21 November 2007 19 Total pharmaceutical market forecast World CAGR 2005–10: 5–10% Europe Market size USD 225–260 billion CAGR 05–10 4–7% Japan Market size USD
Slide 11: Pharmaceutical markets in Eastern Europe
Pharmaceutical markets in Eastern Europe mostly smaller markets with high growth stories Share of Eastern EU sales 2006 Latvia Estonia Lithuania 2% 1% Hungary USD 2.4 billion +12.6% 4% Slovenia 5% Poland Lithuania USD 0.4 billion +15.4% 43% Slovakia Latvia USD 0.2 billion +22.3% 7% Slovakia USD 0.8
Slide 12: Building European presence / Specialty Products business
Building European presence Orion’s value chain Research Sales Development Supply chain – networking and partnering – increased presence in Europe Mid-long term focus on Proprietary Products Short term focus on Specialty Products • Best growth opportunity in products • Strengthening current operation
Slide 13: Breakdown of Specialty Products' net sales
Breakdown of Specialty Products’ net sales 2003–MAT Sep/2007 by segment 250 200 150 100 50 Easyhaler OTC and SC Branded Generics and Generics 0 2003 2004 2005 2006 MAT 9/2007 Capital Markets Day, London 21 November 2007 25 Breakdown of Specialty Products’ net sales 2003–MAT Sep/2007 by geographic ar
Slide 14: Specialty Products' top 10 brands
Breakdown of Specialty Products’ net sales 2003–MAT Sep/2007 by geographic area (excluding Finland) (2/2) 80 60 EUR million per year 40 20 Others Scandinavia Region Germany CEE 0 2003 2004 2005 2006 MAT 9/2007 Capital Markets Day, London 21 November 2007 27 Specialty Products’ top 10 brands by net s
Slide 15: Product launches / Future growth expectation
Product launches in Specialty Products 50 Launches in 2007: by indication area 40 Psychiatry 57 % Number of launches per year Neurology 14 % Oncology/urology 7% 30 OTC 20 % by area 20 CEE 65 % Finland 18 % Scandinavia 14 % 10 Product/Country 0 combinations 2005 2006 2007 Capital Markets Day, London
Slide 16: Update on Proprietary Products business
Capital Markets Day, London 21 November 2007 31 Update on Proprietary Products business London, 21 November 2007 Timo Lappalainen SVP, Proprietary Products and Animal Health Capital Markets Day, London 21 November 2007 32 16
Slide 17: Building European presence / Central Nervous System (CNS)
Building European presence Orion’s value chain Research Sales Development Supply chain – networking and partnering – increased presence in Europe Mid-long term focus on Proprietary Products Short term focus on Specialty Products • Best growth opportunity in products • Strengthening current operation
Slide 18: Orion's top 10 pharma brands / CNS therapy area strategy
Orion’s top 10 pharma brands Moving annual total (MAT) Oct/06–Sep/07 Business MAT MAT Change EUR million division 12 mth pre 12 mth % PP 125.7 96.3 +31% Stalevo® Parkinson’s Disease Enanton Fareston Comtess® /Comtan ® Parkinson’s Disease PP 75.7 73.0 +4% Calcimagon Stalevo Simdax Dexdomitor®,Domitor
Slide 19: Optimising levodopa delivery / Development of PD treatment
Optimising levodopa delivery The use of dopa decarboxylase (DDC) inhibition shifts the metabolism of levodopa to the COMT metabolic pathway Source: Nutt et al 1994, Gordin et al 2002, Stalevo PI 2003 Dual inhibition leads to increased access of levodopa to the brain Capital Markets Day, London 21 No
Slide 20: PD treatment vision / Parkinson's Disease and markets
PD treatment vision Comtess®® Stalevo®® Optimised Optimised levodopa levodopa therapy therapy Full Full dosing dosing flexibility flexibility Levodopa Diagnosis / De Novo Honeymoon / stable period Motor complication period Untreated Treatment starts Wearing-off Severe fluctuations and dyskinesias 1–
Slide 21: Market for the Parkinson's Disease products
Market for the Parkinson’s Disease products Moving annual total (MAT) Oct/2006–Sep/2007 • Total sales of Market shares of Parkinson’s Disease medicines, Orion’s Parkinson’s products vs. MAT Sep/2007 the total sales of PD medicines – in the USA USD 1 188 (977) million, +22% compared to previous MAT 1
Slide 22: Global in-market sales / New on CNS therapy area
Global in-market sales 2001–2006 Stalevo + Comtess/Comtan, 2001–MAT Sep/2007 EUR million 500 409.5 375.6 400 308.1 300 233.3 170.0 200 132.4 103.9 100 Stalevo launch 0 2001 2002 2003 2004 2005 2006 MAT 9/2007 Source: IMS (excl. Russia and Ukraine) Capital Markets Day, London 21 November 2007 43 New
Slide 23: ANDA filings for Comtan and Stalevo / Urology and Oncology
ANDA filings for Comtan and Stalevo in the USA • Abbreviated New Drug Applications (ANDA) for generic versions of Comtan® and Stalevo® have been submitted to the FDA in the USA – On 13 Sep 2007, Orion initiated legal actions with regard to the first application on Comtan submitted by Wockhardt USA,
Slide 24: Orion's top 10 pharma brands / U&O therapy area
Orion’s top 10 pharma brands Moving annual total (MAT) Oct/06–Sep/07 Business MAT MAT Change EUR million division 12 mth pre 12 mth % PP 125.7 96.3 +31% Stalevo® Parkinson’s Disease Enanton Fareston Comtess® /Comtan® Parkinson’s Disease PP 75.7 73.0 +4% Calcimagon Stalevo Simdax Dexdomitor®,Domitor®
Slide 25: New on Urology and Oncology / Toremifene studied by GTx
New on Urology and Oncology therapy area • A marketing authorisation for Divigel ® (estradiol gel) 0.1% was received in June for the USA and in July for Japan – Upsher-Smith Laboratories, Inc. markets the product in the USA is and Pola Chemical Industries Inc. in Japan • A marketing authorisation fo
Slide 26: Critical Care and Cardiology (CCC) / top 10 brands
Critical Care and Cardiology (CCC) Capital Markets Day, London 21 November 2007 51 Orion’s top 10 pharma brands Moving annual total (MAT) Oct/06–Sep/07 Business MAT MAT Change EUR million division 12 mth pre 12 mth % PP 125.7 96.3 +31% Enanton Fareston Stalevo® PD Calcimagon Comtess® /Comtan® PD PP
Slide 27: CCC therapy area strategy / Dexmedetomidine (Precedex)
CCC therapy area and its strategy • CCC business contains two segments with one existing global brand in each – In Critical Care, dexmedetomidine, Precedex®, a sedative used in intensive care unit, presents the existent business – In Cardiology, the strategy is based on treatment of acute decompensa
Slide 28: Simdax / Proprietary Products business review conclusions
Simdax® (levosimendan) • Simdax is an Orion-originated intravenously (i.v.) administered compound for acute decompensated heart failure • Simdax holds 40+ marketing approvals globally – Abbott is the worldwide license holder for the formulation outside the Nordic countries • In April 2007 Abbott ann
Slide 29: Orion's R&D strengths and update on research projects
Capital Markets Day, London 21 November 2007 57 Orion’s R&D strengths and an update on current research projects London, 21 November 2007 Reijo Salonen, SVP R&D Capital Markets Day, London 21 November 2007 58 29
Slide 30: Content / Orion has a proven track record
Content • Orion’s R&D function and operational strengths • Progress both externally and internally • Update on late portfolio (phase III study programmes) – Stalevo life-cycle management – Dexmedetomidine – Easyhaler – Levosimendan in dogs Capital Markets Day, London 21 November 2007 59 Orion has a
Slide 31: Core competencies in research / A target for many diseases
Core competencies in research drug discovery and non-clinical development Genomics & Discovery Bioinformatics biology Alpha 2AR General COMT-inhibition Medicinal Steroid hormone nuclear receptors pharmacology chemistry Pharmacokinetics Toxicology & Bioanalytics Capital Markets Day, London 21 Novembe
Slide 32: Key effects of alpha2C antagonists / Networking and partnering
Target validation key effects of alpha2C antagonists • Antipsychotic-like effect both in models for positive or negative symptoms – phencyclidine (PCP) induced models • Antidepressant-like effects seen in typical depression models – forced swimming test, chronic mild stress • No negative effects in
Slide 33: Concrete steps through bilateral collaboration / R&D by 2017
Concrete steps through bilateral collaboration Scientific agreements in 2007 • Aurigene Discovery Technologies Ltd. – an Indian-based discovery service company – The aim of the collaboration is to identify completely new medicinal approaches to treat cancers – Orion will have exclusive worldwide rig
Slide 34: Phase III Clinical Programs / Major studies in Parkinson's Disease (1/2)
Phase III Clinical Programs Capital Markets Day, London 21 November 2007 67 Major studies in Parkinson’s Disease (1/2) STRIDE-PD in collaboration with Novartis • Life-cycle management of Stalevo (levodopa/carbidopa/entacapone) – seeking label extension into early PD – patients with early PD requirin
Slide 35: Major studies in Parkinson's Disease (2/2) / Dexmedetomidine
Major studies in Parkinson’s Disease (2/2) FIRST STEP conducted by Novartis • FIRST STEP = Favorability of Immediate Release Short Term Comparison in Early Parkinson’s Disease • Life-cycle management of Stalevo (levodopa/carbidopa/entacapone) – seeking label extension into early PD – patients with e
Slide 36: Current status of dexmedetomidine / Clinical studies
Current status of dexmedetomidine • Registered in 46 countries including USA and Japan – sold and marketed by Hospira • Precedex® is indicated for the sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting – currently Precedex® should be ad
Slide 37: Results from the dexmedetomidine pilot study / Phase III development
Results from the dexmedetomidine pilot study Study on 85 patients with expected need of sedation for at least 24 hours. Maximum duration of sedation is 14 days. Dexmedetomidine Standard of Care (SOC) (propofol or midazolam) N:o of patients 41 44 (28+16) Sedation in target (all) 55% 57% Sedation in t
Slide 38: Phase III studies with dexmedetomidine / Combination in Easyhaler
Phase III studies with dexmedetomidine • Randomised double-blind, 500 patients in each study • Mild to moderate long term sedation (>24 h) in intensive care – treatment up to 14 days • Primary endpoints – sedation (non-inferiority) – length of mechanical ventilation (superiority) • Countries in Euro
Slide 39: Orion has developed Easyhaler / Easyhaler milestones
Orion has developed Easyhaler® • Breath-actuated dry powder inhaler • Easy and convenient to use • High and consistent dose delivery • Counter mechanism clearly indicates the number of doses remaining • Reliable therapy for asthma • Effective bronchodilation at low inspiratory flow • Preferred by pa
Slide 40: LEVET-programme (levosimendan) / Conclusions
LEVET-programme (levosimendan) • Oral levosimendan in the treatment of heart diseases in dogs – progressing in the last research phase with an aim to receive marketing authorisations – recruitments in Europe and USA started in August 2007 – the results are currently estimated in late 2008 Capital Ma
Slide 41: Appendixes
Capital Markets Day, London 21 November 2007 81 Appendixes Capital Markets Day, London 21 November 2007 82 41
Slide 42: Orion B share performance / R&D pipeline
Orion B-share in relation to OMXH Portfolio and Europe Pharmaceuticals indexes Update on 5 Nov 07 Orion B 126.62 OMXH Portfolio 133.16 3 July.2006 = 100 closing 20 Nov Europe Pharmaceutical 84.52 150 140 130 120 110 100 90 80 3 .7 .06 3 .8 .06 3 .9 .06 3 .1 0 .06 3 .1 1 .06 3 .1 2 .06 3 .1 .07 3 .2
Slide 43: Net sales from proprietary franchise / Duration of selected patents
Net sales from proprietary franchise By products Q1–Q3/07 Q1–Q3/06 Change 2006 EUR million Proforma % Proforma Stalevo® Parkinson’s Disease 94.6 80.2 +18.0% 111.3 Comtess® /Comtan® Parkinson’s Disease 58.0 57.0 +1.8% 74.7 Domitor®, Domosedan® animal sedatives 21.8 20.2 +8.2% 26.0 and Antisedan® Easy