Orion Oyj Class A · OMXHEX:ORNAV
Orion Oyj Class A — Investor Day (November 2013)
119 slides from Orion Oyj Class A's investor day presentation, Nov 20, 2013
Slide 1: Orion Capital Markets Day 2013
Orion Capital Markets Day 2013 20 November 2013 Helsinki
Slide 2: Agenda
Agenda Orion today Timo Lappalainen, President & CEO Key elements of financial targets Jari Karlson, CFO Orion production strategy Virve Laitinen, SVP, Supply Chain Break R&D pipeline review Reijo Salonen, SVP, Research & Development Proprietary Products update Liisa Hurme, SVP, Proprietary Products
Slide 3: 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 4: Orion today
Orion today Timo Lappalainen President & CEO
Slide 5: Key market development parameters
Key market development parameters • Proprietary markets continue to drive the value IF you have a differentiated product – Market access will be the key – Developed 0-1%(1) • Developed markets are still 74% of the global branded markets in 2016(2) – Pharmaemerging 7-9%(1) • Generics markets have enj
Slide 6: Ownership base 2008-2013
Ownership base 2008-2013 Ownership structure by number of shares Number of shareholders 100% 70 000 80% 60 000 60% 50 000 40% 40 000 20% 30 000 0% 20 000 2008 2009 2010 2011 2012 Oct 2013 10 000 Banks and insurance companies Non-profit organisations 0 Private corporations 2008 2009 2010 2011 2012 Oc
Slide 7: Financial performance in 2008-2012
Financial performance in 2008-2012 Net Sales 2008-2012 Operating Profit 2008-2012 EUR million EUR million 1200 12% 300 32% 31% 1000 10% 250 30% 800 8% 200 29% 600 6% 28% 150 27% 400 4% 100 26% 200 2% 25% 50 24% 0 0% 0 23% 2008 2009 2010 2011 2012 2008 2009 2010 2011 2012 Operating profit Net sales A
Slide 8: Net sales by business divisions 2008-2012
Net sales by business divisions 2008-2012 EUR million 1200 1000 800 68 69 68 600 62 67 321 367 299 275 400 261 118 142 154 89 70 200 208 235 253 267 250 0 2008 2009 2010 2011 2012 Entacapone products Other Proprietary Products Specialty Products Animal Health Fermion Contract Manufacturing Diagnosti
Slide 9: Development of key PP products
Development of key PP products EUR million EUR million 50 300 45 250 40 35 200 30 25 150 20 100 15 10 50 5 0 0 2008 2009 2010 2011 2012 2008 2009 2010 2011 2012 Simdax Precedex Easyhaler dexdor® Stalevo, Comtess & Comtan 9 20 November 2013 Orion CMD 2013 Helsinki
Slide 10: Product protection situation of key products
Product protection situation of key products Key patents or data protection expire Molecule Product Indication Europe USA Japan Entacapone Stalevo®, Parkinson’s disease November 2012 October 2013 2) 2015 3) Comtess® and October 2013 1) Comtan® Levosimendan Simdax® Acute decompensated September Not m
Slide 11: Turning points of Parkinson's franchise
Turning points of Parkinsons’s franchise 2011 2012 2013 2014 2015 Comtess / Comtan in-market sales EUR 35 million in 2011 Entacapone molecule patent Generic versions of Comtess Europe EUR 30 million in 2012 expired 11/2012 Stalevo in-market sales EUR 250 million in 2011 Stalevo data protection expir
Slide 12: Orion's strategy
Orion’s strategy Orion’s values Mutual trust Customer and respect focus Orion people Quality, Partners Innovation reliability and networks and safety Achievement Efficient and competitive operations Management of complexity in cost efficient way 12 20 November 2013 Orion CMD 2013 Helsinki
Slide 13: Orion's partnering framework
Orion’s partnering framework • Part of Orion’s strategy is to share risks and rewards of phase III trials with partners – However, each case merits its individual considerations • Partnering is a long and winding road due to its long-term and substantial financial commitment • Orion’s key considerat
Slide 14: 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 15: Today's presentations
Today’s presentations 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 2012 EUR 48 million (excluding supplies for own use) • Net sales
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Slide 17: Key elements of financial targets
Key elements of financial targets Jari Karlson CFO
Slide 18: Orion's financial objectives
Orion’s financial objectives Orion’s financial objectives are: Operating profit 300 35% • Ensuring financial stability 250 30% • Profitable growth 200 25% Operating profit, 150 20% EUR million The objectives are achieved through: Operating profit, • Increasing net sales. Achievement of this objectiv
Slide 19: Where we are (and have been)
Where we are (and have been) pte a Gnion Building well-being
Slide 20: Product sales and gross profit
Product sales and gross profit - clear decline in margins over last few years • Orion had for many years a Net sales (EUR million) 700 stabile 65% gross profit from Proprietary 600 products sales 500 products • Over the last two years the gross 400 Other products profit has however declined to 300 l
Slide 21: Key components of gross profit change
Key components of gross profit change - from 1-9/2012 to 1-9/2013 490 480 472 470 EUR million 460 450 447 440 430 420 Gross Royalties Prices FX Sales Cogs due Temp Cost Gross profit volume volume cogs increases profit 2012 2013 21 20 November 2013 Orion CMD 2013 Helsinki
Slide 22: Key components of gross profit change
Key components of gross profit change • Price and currency changes have had negative impact • Volumes have increased – Higher sales, higher cost of goods • Product mix impact has also been negative – Increased share of sales generated by lower margin business units • Manufacturing costs have increas
Slide 23: Consistent management of the cost structure
Consistent management of the cost structure Costs by function • Sales have increased 28% from 2009 EUR million to MAT 9/2013 (to EUR 988 million) 350 • Fixed costs have increased 15% over 300 the same period (GS&A costs by 18%) 250 – Establishment of presence in several 200 countries after Simdax ac
Slide 24: Consistent management of the cost structure
Consistent management of the cost structure Employees by function • Headcount has increased by 16% over the last 10 years from 3 000 to 3 500 1600 while sales have increased by 80% 1400 1200 • In several functions there are now less 1000 people than 10 years ago 800 • Areas with increase 600 – Large
Slide 25: Orion has maintained a solid financial position
Orion has maintained a solid financial position • Orion has solid financial position Equity ratio which provides good basis for future 66 development of the company 64 • Maintaining financial strength is an 62 important goal for Orion 60 58 – Capacity to take required R&D risks 2008 2009 2010 2011 2
Slide 26: Development of net working capital
Development of net working capital - Growth a little faster than sales growth % of net sales EUR million 40% 300 250 30% 200 20% 150 100 10% 50 0% 0 -50 -10% -100 -20% -150 6/07 12/07 6/08 12/08 6/09 12/09 6/10 12/10 6/11 12/11 6/12 12/12 6/13 6/07 6/08 6/09 6/10 6/11 6/12 6/13 12/07 12/08 12/09 12/
Slide 27: Development of receivables
Development of receivables - Overdue and bad debt under control • Main part of growth from unexpired 225 EUR million trade receivables which have increased 200 clearly faster than sales 175 – 25 million of the growth is due to a 150 change in one distribution agreement 125 – Growth in sales in regio
Slide 28: Development of inventories
Development of inventories - Increase in value of purchased products EUR million • Inventory values started to increase 250 faster than sales in 2011 after a 200 relatively stabile period • Inventories of internally manufactured 150 goods increased fast until mid 2012 100 • Inventories of purchased
Slide 29: Development of inventories
Development of inventories - Inventory turnover has remained quite stabile • Over a longer period the inventory 400 EUR million Times/year 2,6 turnover has remained quite stabile 350 2,4 • Main driver of the increase in inventory 300 2,2 values have been growth of cost of 250 2,0 goods sold 200 1,8
Slide 30: Currently a peak in capital expenditure
Currently a peak in capital expenditure - Unusually large building investments • Major on-going maintenance 80 EUR million capacity increased investments 70 have increased especially the 60 building capex 50 • Also machinery capex has increased 40 but less than investments on buildings 30 20 • Signi
Slide 31: The way forward
| | ae a The way forward ry . GRION Building well-being
Slide 32: Some challenges
Some challenges • Share of lower margin business areas in Orion continues to increase over the next few years • Pricing pressures continue – Competition in generics, API and diagnostic products – Market access and reimbursement of new proprietary products – Global pressure on costs of health care sy
Slide 33: Continuous improvement
Continuous improvement • Orion tradition has been to improve operations and manage the cost structure all the time – Orion is almost a hundred year old company with long term focus – Need to earn dividends every year since there is no retained earnings buffer – Important driver behind high profitabi
Slide 34: Continuous improvement
Continuous improvement • Orion tradition has been to improve operations and manage the cost structure all the time – Orion is almost a hundred year old company with long term focus – Need to earn dividends every year since there is no retained earnings buffer – Important driver behind high profitabi
Slide 35: Key development programs
Key development programs 1. Improvement of productivity of the supply chain operations – To get value out of the heavy capital expenditure program 2. Improved turnover of net working capital – All components important but main focus on inventory management – Continuous process improvement taking pla
Slide 36: Improvement of supply chain productivity
Improvement of supply chain productivity • Quality and compliance is essential • Service level needs to remain high SERVICE LEVEL 2 QUALITY AND PEOPLE COMPLIANCE • GMP PRODUCTIVITY 1 3 • EHS 36 20 November 2013 Orion CMD 2013 Helsinki
Slide 37: Improvement of supply chain productivity
Improvement of supply chain productivity - Challenging mix of goals Service level to stay high • Demand management • Forecast accuracy • Lead time reduction • Supplier network management and optimization Productivity to be improved • Complexity management skills • Product portfolio management and op
Slide 38: Faster inventory turnover
Faster inventory turnover • Faster turnover without lowering service level – Service level needs to remain high, but it need not to be the same for all type of products and customers -> ABC classification • Key targets – Reduction of inventory value of internally manufactured products and materials
Slide 39: Faster inventory turnover
Faster inventory turnover • Faster turnover without lowering service level – Service level needs to remain high, but it need not to be the same for all type of products and customers -> ABC classification • Key targets – Reduction of inventory value of internally manufactured products and materials
Slide 40: Summary - Actions are driven by financial objectives
Summary - Actions are driven by financial objectives Increasing net sales Profitability at good Equity ratio at level least 50% (EBIT > 20% of net sales) – Compliance and – Management of cost – Good profitability Service level structure – Management of – Cost competitiveness – Management of working
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Slide 42: Orion production strategy
Orion production strategy Virve Laitinen Senior Vice President Supply Chain
Slide 43: Orion Pharma Supply Chain network
Orion Pharma Supply Chain network Suppliers Production Sites Partners & own Customers sales • 2 own API plants by • 4 own final product • Orion subsidiaries • Human products Fermion manufacturing sites by • European wide • Veterinary products Orion Pharma wholesalers and • Suppliers for API distribu
Slide 44: Orion Manufacturing Operations in Finland
Orion Manufacturing Operations in Finland Kuopio Plant | ~50 SC employees Oulu Fermion plant | ~90 employees Production types API production Liquids Suppositories Turku Plant | ~500 SC employees Production types Tablet & capsule production Hormone tablet production Espoo Plant | ~730 SC em
Slide 45: Production footprint development
Production footprint development 2000-2001 Oulu&Seinäjoki Factory close down Products partly centralised to Orion sites and partly 2009 Turku outsourced Powder manufacturing department outsourced 2002 Kemijärvi Factory close down 2013-2014 Salo Products outsourced warehouse and packaging 2004 Kvistg
Slide 46: Production strategy evaluations – focus areas
Production strategy evaluations – focus areas Strategic position Tablet manufacturing and packaging • Strategic products:entacapone, key RX and generic products • Espoo and Turku:tablet manufacturing capacity • Salo:centralised packaging operations and warehousing • Close down one tablet department
Slide 47: Orion's production focus areas
Orion’s production focus areas Salo Plant Espoo Plant Espoo Plant Packaging and warehouse Easyhaler inhalation Tablet production operations by end of 2014 production capacity expansion rationalisation EUR Estimate 2010 2011 2012 million 2013 CAPEX 38 49 50 80 Turku Plant Hormone gel production expan
Slide 48: How do we develop our competitiveness?
How do we develop our competitiveness? Quality and Service Level Productivity Compliance • Ensure robust • Implement customer • Lower costs to improve compliance level with centric approach margins justified Orion approach • Change from supply to • Optimise procurement demand driven • Culture:qualit
Slide 49: Orion Supply Chain focus areas
Orion Supply Chain focus areas: Quality & compliance, service level and productivity SERVICE LEVEL 2 PEOPLE QUALITY AND 1 3 PRODUCTIVITY COMPLIANCE 49 20 November 2013 Orion CMD 2013 Helsinki
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Slide 51: R&D pipeline review
R&D pipeline review Reijo Salonen Senior Vice President R&D
Slide 52: Key clinical pharmaceutical development projects
Key clinical pharmaceutical development projects Clinical phases Project Indication Registration I II III Easyhaler® budesonide-formoterol Asthma, COPD Stalevo® for Japanese markets 1) Parkinson’s disease Easyhaler® salmeterol-fluticasone Asthma, COPD ODM-101 (more effective levodopa product) Parkin
Slide 53: Research projects 2012 (18)
Research projects 2012 (18) HIT Finding Active-To-Hit Hit-To-Lead Lead Optimization ENDO collaboration in oncology 4x Oncology A Oncology B Oncology C Oncology D CNS A CNS B CNS B CNS C CNS D CNS E CNS F CNS G CNS H Super generic Oncology spin out for new indication Precandidate Candidate CTA 53 20
Slide 54: 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 54 20 November 2013 O
Slide 55: ODM-201 – a new generation androgen receptor inhibitor
ODM-201 – a new generation androgen receptor (AR) inhibitor for prostate cancer
Slide 56: 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 57: ODM-201 does not increase serum testosterone levels in vivo
ODM-201 does not increase serum testosterone levels in vivo Serum testosterone levels in xenograft after 3-wk dosing in mouse • ODM-201 does not increase serum testosterone levels like enzalutamide in mouse • In CRPC patients, enzalutamide reported to increase bone marrow testosterone** **Ref. Efsta
Slide 58: Superior inhibition of tumor growth by ODM-201 in xenograft model
Superior inhibition of tumor growth by ODM-201 in castration- resistant mouse VCaP xenograft model • Derived from a bone metastasis of a patient with CRPC • Contains endogenous (wild type, non-mutated) AR gene amplification and AR overexpression Control ADT ADT+enzalutamide (20mg/kg qd) ADT+ODM-201
Slide 59: ODM-201 ARADES Phase I/II Study Design
ODM-201 ARADES Phase I/II Study Design STUDY PHASES: P1 Dose escalation P2 Dose expansion GOAL: Tolerability - MTD Define dose for further clinical trials OBJECTIVES: Safety, PK, Efficacy Safety, Efficacy 900 mg bid 700 mg bid CYP17i-naïve, chemo-naïve 700 mg bid 200 mg bid CYP17i-naïve, post-chemo
Slide 60: ARADES Phase I/II inclusion/exclusion criteria
ARADES Phase I/II inclusion/exclusion criteria • Key inclusion criteria • Key exclusion criteria • Progressive mCRPC • Prior therapy with enzalutamide or any investigational AR antagonist • Chemotherapy-naïve or ≤ 2 prior chemotherapy regimens • Patients with history of seizures or at risk of seizur
Slide 61: Demography for ARADES phase I/II
Demography for ARADES phase I/II (doses 100mg bid / 200mg bid / 700mg bid) ITT population Chemo-/ Post-chemo/ Post-CYP17i CYP 17i-naïve CYP 17i-naïve (n = 37) (n = 32) (n = 55) Age (median years, range) 73 (55–83) 67 (53-82) 69 (55-89) Baseline PSA 101 (2.7–1294) 94 (8.4–663) 139 (8.9–5000) (median
Slide 62: 12 wk PSA response most pronounced in Chemo-/CYP17i naive
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% 62 20 November 2013 Orion CMD 2013 Helsinki
Slide 63: Most common 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 64: Conclusions from clinical studies
Conclusions from clinical studies ODM-201 is a safe and well tolerated treatment • Adverse events were mostly mild, and seemed to be related to prostate cancer or concomitant diseases High response rate in chemo/CYP17i-naïve patients • 700 mg bid has the best responses in chemo-/CYP17i-naïve patient
Slide 65: Future studies with ODM-201
Future studies with ODM-201 A Phase 3 study in nmCRPC patients is scheduled to start recruitment in Q2/2014 • Patients at high risk for developing metastasis as assessed by PSA doubling time • To demonstrate the efficacy of ODM-201 for delaying progression to metastatic disease • Over 300 sites in m
Slide 66: Alpha2C ORM-12741 for Alzheimer's disease
Alpha2C ORM-12741 for Alzheimer’s disease
Slide 67: Introduction - Alpha-2 adrenoceptor subtypes
Introduction -Alpha-2 adrenoceptor (AR) subtypes alpha2A AR alpha2B AR • the “major subtype” • expressed mainly in the • universally expressed periphery, but also in the • mediates most of the prominent thalamus effects of subtype-nonselective • role in peripheral alpha-2 agonists vasoconstriction a
Slide 68: Introduction – ORM-12741
Introduction – ORM-12741 • ORM-12741 is a highly potent and selective alpha-2C adrenoceptor antagonist • Rodent models predict beneficial effects on cognition and neuropsychiatric symptoms • Safe and well tolerated in Phase 1 studies 68 20 November 2013 Orion CMD 2013 Helsinki
Slide 69: ORM-12741 Phase 2a Study in Alzheimer's Disease
ORM-12741 Phase 2a Study in Alzheimer's Disease 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
Slide 70: Positive treatment effect on Quality of Episodic Memory
Clear and statistically significant positive treatment effect on Quality of Episodic Memory (ITT population, changes from baseline) Main treatment effect p=0.03 Pairwise comparisons from baseline up to week 12: 30-60 mg vs. placebo, p=0.046 Improvement 100-200 mg vs. placebo, p=0.012 Effect size at
Slide 71: Positive treatment effect on Quality of Memory
Clear and statistically significant positive treatment effect on Quality of Memory (ITT population, changes from baseline) Values are LSMeans (SEM) Main treatment effect p=0.013 Improvement Pairwise comparisons from baseline up to week 12: 30-60 mg vs. placebo p=0.006 100-200 mg vs. p=0.019 71 20 No
Slide 72: Trend for positive effect in NPI total score
Trend for positive treatment effect in Neuropsychiatric Inventory (NPI) total score for the low dose group (ITT population, changes from baseline) Values are LSMeans (SEM) Main treatment effect p=0.12 Pairwise comparisons from baseline up to week 12: 30-60 mg vs. placebo p=0.11 Improvement 100-200 m
Slide 73: Positive effect on NPI Caregiver Distress score
Clear and statistically significant positive treatment effect on Neuropsychiatric Inventory (NPI) Caregiver Distress score (ITT population, changes from baseline) Values are LSMeans (SEM) Main treatment effect p=0.034 Pairwise comparisons from Improvement baseline up to week 12: 30-60 mg vs. placebo
Slide 74: ORM-12741 Phase 2a Study - Conclusions
ORM-12741 Phase 2a Study - Conclusions • Clear positive effects on memory measures on active treatment groups as compared to placebo – No clear differences in efficacy between the active dose groups • A clear positive treatment effect in NPI Caregiver Distress score for both doses and a positive tre
Slide 75: ORM-12741 Drug development for treatment of AD Next Steps
ORM-12741 Drug development for treatment of AD Next Steps • Phase 2b in AD patients focusing on – Confirmation of Phase 2a results in larger population – Additional endpoints – Dosing • Development options for Phase 3 Cognition Pros’: Several compound shown to work, clear study designs, endpoints
Slide 76: Scenarios for new levodopa products for Parkinson's disease
Scenarios for new levodopa product(s) for treatment of Parkinson’s disease - ODM-101 - ODM-103/104
Slide 77: Main assumptions for new Orion levodopa product(s)
Main assumptions for new Orion levodopa product(s) There is a continuing unmet need for peroral levodopa products with improved efficacy which could be achieved by: • Increasing COMT-inhibition (ODM-103/104) • Improving levodopa formulation • Increasing AADC-inhibition (ODM-101) • Any combination of
Slide 78: ODM-101
ODM-101 • Fixed combination tablet for peroral administration of levodopa, carbidopa and entacapone • The ratios, strengths and pharmaceutical formulations of levodopa, carbidopa and entacapone have been improved • The target indication of ODM-101 is Parkinson´s disease and end-of- dose motor fluctu
Slide 79: ODM-101 PoC study
ODM-101 PoC study • Efficacy and safety of ODM-101 compared to a standard combination (Stalevo®); a randomized, double-blind, crossover, proof of concept (PoC) study in patients with Parkinson’s disease and end-of-dose motor fluctuations • Randomized, three 4 week period cross-over comparison of ODM
Slide 80: Summary of ODM-101 PoC study key results
Summary of ODM-101 PoC study key results ODM-101 was more effective than Stalevo • ODM-101 65 and 105 mg reduced mean daily OFF-time by 0.6 (p = 0.021) and 0.7 (p = 0.015) hours*. • ODM-101 65 and 105 mg increased mean daily ON-time without troublesome dyskinesia by 0.6 hours (p=0.053 and 0.033)* •
Slide 81: Status of development ODM-101
Status of development ODM-101 Phase I • Pharmacokinetics studies completed. Phase II • PoC study completed in Q4 2012. Phase III • FDA and EMA advise for further development available • FDA’s Special Protocol Assessment (SPA) completed and the agreement on pivotal phase III studies available • Partn
Slide 82: Current status with ODM-103 and ODM-104 in Phase I
Current status with ODM-103 and ODM-104 in Phase I ODM-103 Phase I study: • Single dose part completed; dosing up to 400 mg • Repeated dose part ongoing; dosing currently up to 200 mg • Well tolerated and effective COMT-inhibitor • ODM-103 dose escalation put on hold to wait ODM-104 to catch up for
Slide 83: 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
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Slide 85: Proprietary Products update
Proprietary Products update Liisa Hurme Senior Vice President Proprietary Products
Slide 86: Proprietary Products business transition is successful
Proprietary Products business transition is successful Steady growth of PP portfolio with new • Robust entacapone sales have products and robust entacapone sales 450 been successfully supplemented with new sales 400 350 300 • Product portfolio has expanded EUR million 250 as planned: 200 – Simdax +1
Slide 87: Proprietary Products business transition is successful
Proprietary Products business transition is successful Equation between owns sales and royalties from • Proprietary product sales have partners has changed been quite stable for the past few 450 years 400 350 • Strengthening the European 300 EUR million market position: 250 200 – Orion sales organis
Slide 88: Entacapone franchise status and prognosis in USA and Europe
Entacapone franchise status and prognosis in USA and Europe Comtan TRx value share - USA Stalevo TRx value share - USA Comtan Stalevo 9% 20% Source: IMS Health, TRx sales in USA, 9/2013 In Europe Stalevo data exclusivity expired on Oct 23, 2013 • No marketing authorisations granted thus far • To dat
Slide 89: Stalevo has untapped potential in Rest of the World
Stalevo has untapped potential in Rest of the World Japan Entacapone franchise sales development in RoW • Stalevo regulatory 80 process ongoing 70 China 60 • Stalevo market access EUR million 50 process ongoing 40 Other RoW markets 30 growing* 20 • China Comtan +52% 10 • Mexico Comtan & Stalevo +13%
Slide 90: CNS Business to be continued with wider scope
CNS Business to be continued with wider scope Levodopa handling Build beyond Maximise optimatisation Parkinson’s Disease entacapone ongoing including with other franchise globally the new neurodegenerative on corporate level COMTinhibitors diseases 90 20 November 2013 Orion CMD 2013 Helsinki
Slide 91: Dexmedetomidine franchise going strong globally
Dexmedetomidine franchise going strong globally Sweden Germany USA France 23.5 Japan 10.4 0.0 APAC 41.9 18.1 Spain Austria Italy 11.2 0.0 0.1 14.5 Market share (%) in value (€) of dexmedetomidine products Dexdor (Europe) and Precedex (ex-Europe) of injectable propofol, midazolam, remifentanil and de
Slide 92: dexdor takes its share in Europe
dexdor® takes its share in Europe dexdor® sales in Europe 14 12 10 EUR million 8 6 4 2 0 2011 2012 YTD62013 Source: IMS Health 92 20 November 2013 Orion CMD 2013 Helsinki
Slide 93: Drivers for Proprietary Products Growth
Drivers for Proprietary Products Growth New product opportunities • Easyhaler budesonide-formoterol • Easyhaler salmeterol-fluticasone • ODM-201 • ORM-12741 Current business New territories for existing New customers products • Insurance companies • Simdax for USA • Pharmacies • Easyhaler mono produ
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Slide 95: How Specialty Products is succeeding in Generics?
How Specialty Products is succeeding in Generics? Markku Huhta-Koivisto Senior Vice President Specialty Products
Slide 96: Large portfolio of off-patent prescription and self-care products
Large portfolio of Off-patent prescription products and self-care products for GPs, specialists, pharmacists, hospitals and consumers • Branded generics market value and Breakdown of SpP net sales by potential is growing product type 2012 – products with added value – some Eastern European markets a
Slide 97: SpP steady sales growth during last years
SpP steady sales growth during last years - Finland dominates, Scandinavia growing - Orion’s second largest business with sales in over 100 countries Breakdown of SpP net sales by Development of SpP net sales geographic area 2012 from 2006 to MAT9/2013 400 350 12% 5% 300 250 14% MEUR 200 59% 150 10%
Slide 98: Orion's strategy
Orion’s strategy Orion’s values Mutual trust Customer and respect focus Orion people Quality, Partners Innovation reliability and networks and safety Achievement Efficient and competitive operations Management of complexity in cost efficient way 98 20 November 2013 Orion CMD 2013 Helsinki
Slide 99: How are we getting our products
How are we getting our products • Develop ourselves to Orion’s own production SpP launches by the source • Use CROs to develop to Orion’s own 140 production 120 • Utilize the patent opportunity for 100 expiring own PP products 80 Distribution • Use CRO/CMO for development and 60 In-licensed manufact
Slide 100: SpP launches 2007 – YTD10/2013
SpP launches 2007 – YTD10/2013 Number of product/country combinations 160 140 120 100 80 60 40 20 0 2004 2005 2006 2007 2008 2009 2010 2011 2012 YTD10 2013 Launches No-launch 100 20 November 2013 Orion CMD 2013 Helsinki
Slide 101: Where is our growth coming? Product types
Where is our growth coming? Product types 250 200 Sales MEUR 150 100 50 0 2006 2007 2008 2009 2010 2011 2012 MAT9 2013 Gx Branded Gx OTC/SeCa Gx entacapone 101 20 November 2013 Orion CMD 2013 Helsinki
Slide 102: Where is our growth coming? Geographical areas
Where is our growth coming? Geographical areas EUR million EUR million 250 60 50 200 40 150 30 100 20 50 10 0 0 2006 2007 2008 2009 2010 2011 2012 MAT9 2006 2007 2008 2009 2010 2011 2012 MAT9 2013 Finland Abroad 2013 Scandinavia Eastern Europe Other Europe Others 102 20 November 2013 Orion CMD 2013
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Slide 104: Orion Diagnostica
Orion Diagnostica Jaakko Rissanen President
Slide 105: Orion Diagnostica – Building Well-being
Orion Diagnostica – Building Well-being
Slide 106: The IVD market is changing - Openings for growth potential
The In Vitro Diagnostics (IVD) market is changing - Openings for growth potential Shortage of skilled laboratory personnel Technological Aging population advances Industry & provider Increase of consolidation chronic diseases IVD market Increased patient Health economics awareness Focus towards Cost
Slide 107: Characteristics of diagnostics business
Characteristics of diagnostics business Time, cost and risk level Diagnostics compared with Leveraging the assets Pharmaceutical business Pharma • Shorter time Rx products • typical time to market 2-5 yrs Proprietary NCE OTC products • Lower cost • 0.1- 10 mEur Animal Health Diagnostics products • L
Slide 108: Global IVD market is expected to grow 5% annually
Global IVD market is expected to grow 5% annually • An estimated USD 50 billion market. Worldwide IVD market 2011 Expected to exceed USD 64 billion in 2016. (USD billion) & CAGR 2011-20161 Annual growth in developed countries ~5%.1 5.5 3.3 Europe, CAGR +1% 14.6 • Europe, North America and Japan abou
Slide 109: Point-of-Care market is broad & fragmented - and growing
Point-of-Care market is broad & fragmented - and growing OTC/Self testing market Professional POC market Total POC testing market • 2011: USD 15.300 million • 2016: USD 18.400 million • CAGR: 4% OTC/Self testing market • 2011: USD 9.624 million • 2016: USD 11.616 million • CAGR: +4% Professional POC
Slide 110: Point-of-Care testing holds a lot of promise
Point-of-Care testing holds a lot of promise • POC testing Professional POC market – shortens time between sample taking and 7000 6765 analysis 6500 – speeds up diagnosis and treatment CAGR 4-7% 6000 – improves clinical outcome 5660 – allows patients to be managed efficiently 5500 and more cost effe
Slide 111: Orion Diagnostica: Smart Solutions for Healthcare & Hygiene Monitoring
Orion Diagnostica: Smart Solutions for Healthcare & Hygiene Monitoring • Accurate and affordable clinical diagnostic and hygiene monitoring tests, which are easy to use and provide fast results. • Focus on point-of-care diagnostic (POC) tools, which enable healthcare professionals to detect disease
Slide 112: Business areas
Business areas • Point-of-Care - QuikRead® Rapid tests to general practitioners, family doctors, paediatricians, healthcare centres, occupational healthcare, nursing homes, emergency departments Point-of-Care testing • Small and mid-sized laboratories - High quality test kits and reagents For clinic
Slide 113: Point-of-Care Tests
Easy to use Point-of-Care Tests solutions to our customers The QuikRead® System • For measuring C-reactive protein (CRP) from a small finger-stick blood sample • Result in two minutes • A CRP test performed during patient consultation helps clinicians to differentiate between bacterial and viral inf
Slide 114: Orion GenRead
® Orion GenRead Our newest platform for Molecular Diagnostics • Built on SIBA®, a rapid and reliable isothermal nucleic acid amplification technology. • Orion Diagnostica has all rights to this patented, proprietary technology. • A flexible benchtop solution including a small instrument and ready to
Slide 115: Conventional PCR vs. Isothermal NAT
Conventional PCR vs. Isothermal NAT Some features Orion CMD 2013 Helsinki 20 November 2013 115
Slide 116: Hygiene Monitoring
Easy to use Hygiene Monitoring solutions to our customers Simple and practical tools for settings where surface cleanliness is crucial • Healthcare settings: For effective infection control • Food processing and food service: For ensuring a safe food chain • Industrial enterprises: For checking micr
Slide 117: Orion Diagnostica Network
Orion Diagnostica Network Distributor • In addition to own products, Orion Diagnostica sells products by well-established diagnostics manufacturers. • Own sales units in Finland, Sweden, Norway, Denmark, Czech Republic, and Germany with an established customer base, local market insight and a motiva
Slide 118: Thank you!
THANK YOU! Orion CMD 2013 Helsinki 20 November 2013 118
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