Slide 1: Orion Capital Markets Day 2017
Orion Capital Markets Day 2017 18 May 2017 Helsinki
Slide 2: Agenda
Agenda Orion’s century 1917-2017 Movie Orion’s Strategy Timo Lappalainen, President & CEO R&D update, part I Christer Nordstedt, SVP, Research & Development Break Specialty Products update Liisa Hurme, SVP, Specialty Products Proprietary Products update Markku Huhta-Koivisto, SVP, Proprietary Produc
Slide 3: Disclaimer
Disclaimer 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 anticipated benefits of
Slide 4: Orion's century 1917-2017
Orion’s century 1917-2017 Watch the film 4 18 May 2017 Orion Capital Markets Day 2017
Slide 5: Orion's centennial
Orion’s centennial www.orion.fi/en/orion100 5 18 May 2017 Orion Capital Markets Day 2017
Slide 6: Orion's Strategy
Orion’s Strategy Timo Lappalainen, President & CEO
Slide 7: Orion today – year 2016 in figures
Orion today – year 2016 in figures Net sales 1,074 MEUR Sales split by business Sales split by market area Operating profit 315 MEUR 4% 5% 4% 13% Personnel 3 469 8% 7% 32% 33% R&D investments 31% 118 MEUR 16% 47% 6 production sites in Proprietary Products Finland Finland Specialty Products Animal He
Slide 8: Orion has operations in 27 countries
Orion has operations in 27 countries -HQ -Research & development Finland -Six production sites -Sales unit -Support functions -Sales unit UK -Research & development Europe -Sales unit in 26 countries India -Support functions ROW - Global partner network 8 18 May 2017 Orion Capital Markets Day 2017
Slide 9: Key developments 2014 to 2016
Key developments 2014 to 2016 +28 MEUR + Easyhaler budesonide-formoterol combination launches in Europe + 3 new projects in clinical developement pipeline +22 MEUR (darolutamide mHSPC, ODM-109, ODM-207) + MAA for Easyhaler salmeterol-fluticasone Specialty combination product in Europe Products + New
Slide 10: Orion's strategy — Mission to build well-being
Orion’s strategy — Mission to build well-being 10 18 May 2017 Orion Capital Markets Day 2017
Slide 11: Orion's values
Orion’s values Customer focus Mutual Quality, trust and respect Orion people reliability and safety Building Well-being Innovation Achievement 11 18 May 2017 Orion Capital Markets Day 2017
Slide 12: Proprietary Products back on growth track
Proprietary Products back on growth track Other 450 30% 400 25% Precedex 350 20% Simdax 300 15% EUR million 250 10% Easyhaler 200 5% Dexdor 150 0% 100 -5% Comtan/ R&D Pipeline Comtess 50 -10% Stalevo 0 -15% 2012 2013 2014 2015 2016 Growth, % 12 18 May 2017 Orion Capital Markets Day 2017
Slide 13: Steady sales growth for Specialty Products
Steady sales growth for Specialty Products Sales split 2016 600 20% 13% Biosimilars 450 15% 12% EUR million 16% 59% 300 10% Gx 150 5% Finland 0 0% Scandinavia OTC 2012 2013 2014 2015 2016 Eastern Europe & Russia Net sales Growth, % ROW 13 18 May 2017 Orion Capital Markets Day 2017
Slide 14: Animal Health – something old, something new
Animal Health – something old, something new 100 15% 75 10% EUR million R&D pipeline 50 5% 25 0% 0 -5% 2012 2013 2014 2015 2016 Net sales Growth, % Partners 14 18 May 2017 Orion Capital Markets Day 2017
Slide 15: Fermion has an important strategic role
Fermion has an important strategic role 80 45% 60 30% EUR million 40 15% 20 0% Generic APIs for APIs for Orion’s Contract Orion and other proprietary development and 0 -15% products pharmaceutical manufacturing 2012 2013 2014 2015 2016 companies Net sales* Growth, % *) Excluding supply to Orion 15 1
Slide 16: Contract manufacturing & other
Contract manufacturing & other 50 45% 40 30% EUR million 30 15% 20 0% 10 -15% Pharmaceutical Orion has special manufacturing for capacity e.g. in 0 -30% other companies hormonal gel products 2012 2013 2014 2015 2016 Net sales Growth, % 16 18 May 2017 Orion Capital Markets Day 2017
Slide 17: Orion Diagnostica
Orion Diagnostica 60 20% 50 15% EUR million 40 10% 30 5% 20 0% 10 -5% 0 -10% 2012 2013 2014 2015 2016 Net sales QuikRead GenRead Operating profit Sales growth, % Operating profit margin 17 18 May 2017 Orion Capital Markets Day 2017
Slide 18: Investments for future growth
Investments for future growth Fermion’s new Easyhaler production R&D production facility capacity expansion 18 18 May 2017 Orion Capital Markets Day 2017
Slide 19: Orion's financial objectives
Orion’s financial objectives Growing net sales more rapidly than ≥ growth of the pharmaceuticals market. Achievement of this objective requires continuous investment in Keeping the equity ratio at least 50%. development of the product portfolio. Distributing an annual dividend that > Maintaining p
Slide 20: World pharma market development
World pharma market development 20 18 May 2017 Orion Capital Markets Day 2017
Slide 21: R&D review Part I
R&D review Part I Christer Nordstedt SVP, Research & Development
Slide 22: Previous Experience – Christer Nordstedt 1/2
Previous Experience – Christer Nordstedt 1/2 1983 1990 1997 2000 2007 2011 2017 Academia Lab Head Various Vice President roles with increasing responsibilities (MD, PhD, post-doc) 22 18 May 2017 Orion Capital Markets Day 2017
Slide 23: Previous Experience - Christer Nordstedt 2/2
Previous Experience - Christer Nordstedt 2/2 Extensive experience of Strong interest in Extensive experience of small molecule and translational aspects partnering (in- and out biologics (monoclonal (bringing basic research licensing, academic antibodies and other to practical patient use) collabora
Slide 24: Research Philosophy
Research Philosophy Mechanistic approach Agnostic with regard to diseases – “The patient comes to modalities – small Understanding and first!” molecules, biologics targeting underlying and beyond disease processes “The power of Wearable technology genetics” – Finland and “digital an excellent arena
Slide 25: Building the R&D future success
Building the R&D future success 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026 Innovation system Competence base Work forROADMAP the future ongoing Therapy area work ODM-207 ODM-109 Bringing treatments to patients addressing unmet needs also in ODM-203 the future require capability to discov
Slide 26: R&D development portfolio is maturing
R&D development portfolio is maturing and more confirmatory programs expected in the portfolio M€ 14 140 12 120 On hold N of projects 10 100 8 80 Confirmatory 6 60 phase Exploratory 4 40 phase 2 20 0 0 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 * * non-probabilitized projections 26 18 May 201
Slide 27: On-going drug development projects at Orion R&D
On-going drug development projects at Orion R&D (May 2017) Phase I Phase II Phase III Registr. N=1 N=4 N=2 N=1 ODM-207 ORM-12741 Darolutamide EH Salmeterol/ BET inhibitor α2C antagonist AR*-inhibitor Fluticasone (solid tumors) (Alzheimer’s disease) (prostate cancer, (asthma and COPD¥) nmCRPC**) ODM-
Slide 28: Key clinical pharmaceutical development projects 1/2
Key clinical pharmaceutical development projects 1/2 Project Indication PHASE Registration Bioequivalence Easyhaler® salmeterol-fluticasone Asthma, COPD Registration study Darolutamide (ODM-201) 1) Prostate cancer (nmCRPC) I II III Darolutamide (ODM-201) 1) Prostate cancer (mHSPC) I II III Levosimen
Slide 29: Key clinical pharmaceutical development projects 2/2
Key clinical pharmaceutical development projects 2/2 Project Indication PHASE Registration ODM-109 (oral levosimendan) ALS I II ORM-12741 (alpha-2c adrenoceptor antagonist) 3) Alzheimer’s disease I IIa ODM-104 (more effective COMT inhibitor) Parkinson’s disease I II ODM-203 (targeted FGFR+VEGFR inhi
Slide 30: R&D portfolio: Human proprietary projects
R&D portfolio: Human proprietary projects in research and development phase High Antiandrogen COMT-i Darolutamide Easyhaler ODM-104 pipeline Probability of success Levosimendan Technical feasibility Alpha2C ODM-109 ORM-12741 FGFR-i BET-i ODM-203 ODM-207 Pain Oncology NDD Pain Pain Pain NDD Pain NDD
Slide 31: Several academic and other collaborations
Several academic and other collaborations both in early and late phase of development 31 18 May 2017 Orion Capital Markets Day 2017
Slide 32: Salmeterol-fluticasone Easyhaler
Salmeterol-fluticasone Easyhaler Easyhalers for treatment of asthma and COPD 32 18 May 2017 Orion Capital Markets Day 2017
Slide 33: Easyhaler portfolio expanding
Easyhaler® portfolio expanding 2004 Formoterol 1994 Beclomet Salmeterol-fluticasone Easyhaler® in 2014 Bufomix Easyhaler® Easyhaler® Easyhaler® registration phase in Europe (budesonide-formoterol) (formoterol) (beclomethasone) Favorable bioequivalency study results at the end of 2016 We have utilise
Slide 34: Darolutamide (ODM-201)
Darolutamide (ODM-201) A novel second generation androgen receptor (AR) inhibitor for the treatment of prostate cancer In collaboration with Bayer 34 18 May 2017 Orion Capital Markets Day 2017
Slide 35: Darolutamide has a unique profile
Darolutamide has a unique profile Enzalutamide 19%* Apalutamide 29%* Darolutamide 3% ** Enzalutamide Apalutamide Darolutamide 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
Slide 36: Darolutamide Clinical studies
Darolutamide Clinical studies Daily Dose ClinicalTrials.gov Study Phase Populations N Status identifier (mg) mCRPC* • Chemo/CYP17 naïve ARADES I/II 134 200-1800 Completed NCT01317641 • Post chemo/ CYP17 naïve • Post CYP17 mCRPC* • Chemo/CYP17 naïve ARADES ext II 76 200-1800 Completed NCT01317641 • P
Slide 37: Darolutamide showed significant and durable antitumour activity
Darolutamide showed significant and durable antitumour activity at clinical dose levels (phase I/II studies, mCRPC patients naïve for chemotherapy and CYP17-inhibitor, 1200, 1400, and 1800 mg bid) Maximum PSA* % change from baseline PSA* % change from baseline Each bar (left) or line (right) represe
Slide 38: Darolutamide Phase III study in nmCRPC
Darolutamide Phase III study ongoing in non-metastatic castration resistant prostate cancer (nmCRPC) ● nmCRPC patients who are at high risk for developing metastatic disease are included ● Primary endpoint – Darolutamide over placebo in metastasis-free survival (MFS) ● Secondary endpoints – Overall
Slide 39: Darolutamide Phase III study in mHSPC
Darolutamide Phase III study ongoing in metastatic hormone sensitive prostate cancer (mHSPC) ● mHSPC patients candidate for ADT (hormonal therapy) and docetaxel (chemotherapy) are included. Treatment Darolutamide with ADT and six cycles of docetaxel ● Primary endpoint – Darolutamide over placebo in
Slide 40: ODM-203
ODM-203 A unique and selective dual FGFR+VEGFR inhibitor for FGFR-dependent tumors 40 18 May 2017 Orion Capital Markets Day 2017
Slide 41: Rationale for combining FGFR and VEGFR inhibition
Rationale for combining FGFR* and VEGFR** inhibition Constitutively active FGFRs are oncogenic in non-clinical studies Both VEGFR and FGFRs are drivers for angiogenesis, a hallmark of tumorigenesis FGFR amplifications have an impact on patient survival in studied cancer types (breast, lung, and gast
Slide 42: 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 43: ODM-203 is the only equally balanced dual FGFR/VEGFR inhibitor
ODM-203 is the only equally balanced selective dual FGFR*/VEGFR** inhibitor No FGFR* inhibitors on the market In vitro kinase activity Cell based activity Ratio ODM-203 Lucitanib Cell line (receptor), Ratio ODM-203 Lucitanib FGFR1/VEGFR2 1:1 1:6 FGFR/Angiogenesis 1:2 1:100 • ODM-203 has very high ki
Slide 44: ODM-203 Best tumour response in KIDES study
ODM-203 Best tumour response (RECIST*) in KIDES study Patients were generally not selected by molecular screening and tumor genetic profiling data are incomplete • 5 partial responses with durable stable disease in a number of other patients. • 2 patients have received ODM-203 treatment for >1 year
Slide 45: ODM-203 – current status
ODM-203 – current status ODM-203 (targeted FGFR+VEGFR inhibitor) Solid tumours I II KIDES trial with Phase II expansion ongoing ● The trial is investigating – Safety and tolerability of ODM-203 in subjects with advanced solid tumours – Efficacy of ODM-203 in slowing the growth of solid cancerous tum
Slide 46: ODM-207
ODM-207 Unique BET inhibitor for solid tumors 46 18 May 2017 Orion Capital Markets Day 2017
Slide 47: Target: BET proteins which regulate expression of oncogenes
Target: BET proteins which regulate expression of oncogenes ● BET proteins occupy regulatory elements of DNA (superenhancers) in many key oncogenes – They increase the expression target oncogenes ● BET target genes include: Myc, MycN ODM-207 • Binds to BET proteins • Inhibits transcription of key on
Slide 48: ODM-207 – A unique BET inhibitor for solid tumours
ODM-207 – A unique BET* inhibitor for solid tumours Potent and selective BET* inhibitor Good physico- Structure different than chemical properties JQ1** derivatives Phase I ongoing Patent applications ODM-207 filed ODM-207 is an investigational small molecule that has a unique chemical structure des
Slide 49: ODM-207 inhibits tumour growth in prostate cancer xenograft
ODM-207 inhibits the tumour growth in enzalutamide-resistant 22Rv1 prostate cancer xenograft Effect of ODM-207 on tumour volumes Effect of ODM-207 on tumour weights ODM-207 inhibits Myc in in vivo efficacy study From poster Björkman et al., presented in EORTC-NCI-AACR in 11-12/2016 49 18 May 2017 Or
Slide 50: ODM-207 – current status
ODM-207 – current status ODM-207 (BET protein inhibitor) Cancer I BETIDES phase I/II trial ongoing ● The trial is investigating – PK, safety and tolerability, and antitumour activity of ODM-207 in subjects with advanced solid tumours ClinicalTrials.gov identifier: NCT03035591 50 18 May 2017 Orion Ca
Slide 51: Specialty Products – strong offering of generics, biosimilars and self-care
Specialty Products – strong offering of generic prescription drugs, biosimilars and self-care Liisa Hurme Senior Vice President, Specialty Products Chairman of the Board, Fermion Oy
Slide 52: Specialty Products division has generated steady sales growth
Specialty Products division has generated steady sales growth 600 SpP Key figures from 2016 500 ~2 300 MAs 400 EUR million 300 ~3 400 SKUs 200 100 Net sales EUR 508 0 million 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 52 18 May 2017 Orion Capital Markets Day 2017
Slide 53: Generic Prescription Drugs and Nordics in Focus
Generic Presciption Drugs and Nordics in Focus Breakdown of SpP net sales by Breakdown of SpP (Gx & OTC) net Business Units 2016 sales by geographic area 2016 4% 8% 9% Finland 21% 12% Scandinavia Eastern Europe 16% 59% 71% Other Europe Other countries Gx OTC Biosimilars 53 18 May 2017 Orion Capital
Slide 54: Generic Prescription Drugs
Generic Prescription Drugs 54 18 May 2017 Orion Capital Markets Day 2017
Slide 55: SpP Gx business has outperformed market growth
SpP Gx business has outperformed market growth Leading generic company in Finland ● Nordic region is Orion’s home base for generic Leading company products in OTC in Finland ● In Finland, Orion continues to be the leading Scandinavia Orion generics player with 42% market share +9% +38% Finland Orion
Slide 56: Recent changes in Finland will have an effect on market value
Recent changes in Finland will have an effect on market value Orion’s position in Finland is strong Recent Changes in the Finnish Pharmaeutical Market Finland generics & biosimilars market in 2016 All others ● Price band decreased from EUR 1.5 to EUR 0.5 +4% Orion +14% ● Inclusion of the parallel im
Slide 57: Change in Finnish reimbursement system for generics
Change in Finnish reimbursement system for generic prescription drugs Price corridor prior 2017 Price corridor 1.1.2017 €3.00 €3.00 €2.50 Brand F, EUR X + 2.25 €2.50 Brand F, EUR X + 2.25 €2.00 €2.00 Brand E, EUR X + 1.75 Brand E, EUR X + 1.75 €1.50 €1.50 Brand D, EUR X + 1.49 Brand D, EUR X + 1.4
Slide 58: Orion is one of the fastest growing Gx companies in Scandinavia
Orion is one of the fastest growing Gx companies in Scandinavia Scandinavia generics & biosimilars market Denmark generics & biosimilars market in 2016 was + 9 % from 2015 in 2016 was + 8% from 2015 Sandoz/ Hexal +5% Sandoz/ Hexal +4% Orion +38% All others All others Allergan - -1% Orion +67% +11% 9
Slide 59: Biosimilars are driving the market growth
Biosimilars are driving the market growth Market volume and value growth by Market volume and value growth by market type market type 16% 250% 14% Gx volume 200% CAGR 2014-2016 CAGR 2014-2016 12% 10% GX & BS 150% 8% volume Gx volume 6% Gx value 100% BS volume 4% 50% Gx value Gx & BS 2% value BS valu
Slide 60: Self Care Business
Self Care Business 60 18 May 2017 Orion Capital Markets Day 2017
Slide 61: The non-medicinal market is growing
The non-medicinal market is growing as people are more health conscious Orion OTC market sales in Finland Total OTC market sales in Finland 60 250 50 200 EUR million EUR million 40 150 30 100 20 10 50 0 0 2013 2014 2015 2016 2013 2014 2015 2016 Medicinal Non-medicinal Medicinal Non-medicinal Source:
Slide 62: Biosimilar Business
Biosimilar Business 62 18 May 2017 Orion Capital Markets Day 2017
Slide 63: Infliximab use has expanded in Nordics with biosimilar entries
Infliximab use has expanded in Nordics with biosimilar entries Infliximab volume development Total market value has in the Nordics not increased 160 Infliximab Volume growth % 80 2014 140 volume 2016 vs. 2015 70 Infliximab volume (SU) 2015 120 22% 60 EUR million Finland 2016 100 50 80 Sweden 9% 40 3
Slide 64: Biosimilar infliximab volume growth in Nordics
Biosimilar infliximab volume growth in Nordics 2016 vs. 2015 was 114% Biosimilar infliximab value growth in Nordics Biosimilar Volume growth % 35 infliximab 2016 vs. 2015 30 Finland 233% 25 EUR million Sweden 374% 20 Finland 15 Denmark Denmark 88% 10 Sweden Norway 70% 5 Norway Scandinavia 98% 0 Nord
Slide 65: Remsima commercialisation timelines and market shares
Remsima commercialisation timelines and market shares 2014 2015 2016 2017 Remsima MS% development of infliximab value 100% Norway LIS 80% Denmark (Amgros) 60% Sweden 40% Finland 20% Others (Estonia, Iceland) 0% NOR DEN SWE FIN Nordics Q414 21% 0% 0% 0% 4% Q415 63% 96% 12% 1% 37% Q416 1% 100% 24% 34%
Slide 66: Positive outlook in all markets with challenges in Finland
Positive outlook in all markets with challenges in Finland Market share development Gx market size in 2016 of Orion Gx (MEUR) Gx Growth Market 2017-2021 14% of total Gx sales 12% 10% Finland Finland +4.3% 8% 478 6% Sweden Sweden +3.4% 4% 613 Poland 2% 2370 0% Denmark Poland +6.3% 453 Russia +8.7% No
Slide 67: Specialty Products continue with three businesses
Specialty Products continue with three businesses ….. Generic Prescription Drugs: Ensure constant renewal and competitiveness of the porfolio Focus on in key markets current Geographic OTC Products: Keep the market share in Territory Finlands and grasp the non-medicinal with market trend with new pr
Slide 68: Proprietary Products
Proprietary Products Markku Huhta-Koivisto SVP, Proprietary Products
Slide 69: Parkinson's drugs
Parkinson’s drugs 60 Sales of Orion’s branded Parkinson drugs 50 by market area MAT12/2016* 3% EUR million 40 30 20 27% Europe 10 42% Japan 0 ROW Q2Q3Q4Q1Q2Q3Q4Q1Q2Q3Q4Q1Q2Q3Q4Q1 USA 2013 2014 2015 2016 17 28% Orion sales Deliveries to Novartis *Source: IMS Health sales statistics MAT12/2016 69 18 M
Slide 70: Parkinson's drugs in key areas
Parkinson’s drugs in key areas Entacapone sales in Japan LCE* product sales in EU5 80 160 70 140 60 120 EUR million EUR million 50 100 LCE Others Stalevo 40 80 LCE Orion Comtan 30 60 Stalevo 20 40 10 20 0 0 2013 2014 2015 2016 2013 2014 2015 2016 Source: QuintilesIMS Source: QuintilesIMS *) LCE = le
Slide 71: Parkinson's drugs in key areas, different dynamics
Parkinson’s drugs in key areas, different dynamics LCE* product sales in Germany 70 60 50 EUR million 40 LCE Others 30 LCE Orion 20 Stalevo 10 0 2013 2014 2015 2016 Source: QuintilesIMS *) LCE = levodopa/carbidopa/entacapone 71 18 May 2017 Orion Capital Markets Day 2017
Slide 72: Parkinson's drugs in key areas, different dynamics
Parkinson’s drugs in key areas, different dynamics LCE* product sales in LCE* product sales in LCE* product sales in Spain France Italy 30 40 20 25 35 30 15 EUR million EUR million EUR million 20 25 15 20 10 10 15 10 5 5 5 0 0 0 2013 2014 2015 2016 2013 2014 2015 2016 2013 2014 2015 2016 Stalevo LCE
Slide 73: Easyhaler update
Easyhaler update Bufomix Easyhaler net sales, Available strengths: 2016 growth +24% 20 80/4.5 &160/4.5 µg/inhal 18 320/4.5 µg/inhal 16 EUR million 14 Co-marketing deal with Menarini 12 Marketing deal with Hikma in 10 Middle East North-Africa region 8 6 MA in 27 countries 4 2 Orion is launching in Ge
Slide 74: Bufomix Easyhaler
Bufomix Easyhaler Total sales in 2016: EUR 26.5 million (+72%) ITALY OTHER EUROPE SPAIN POLAND SWEDEN FINLAND BELGIUM HUNGARY DENMARK 74 18 May 2017 Orion Capital Markets Day 2017
Slide 75: Budesonide-formoterol Easyhaler (1st wave)
Budesonide-formoterol Easyhaler Outcome of the 1st wave DCPs / National registrations MA granted in the 1st DCP 160/4.5 and 320/9 µg/dose Countries withdrawn from the 1st DCP / National process in Switzerland No MAs applied yet MA = Marketing Authorization 75 18 May 2017 Orion Capital Markets Day 20
Slide 76: Budesonide-formoterol Easyhaler (2nd wave)
Budesonide-formoterol Easyhaler Outcome of the 2nd wave DCPs / National registrations 80/4,5 µg/dose: 23 1st wave countries, 1st MAs Q2/2016, 1st launches Q2-Q3/2016 • DK, SE, FI, CZ, IE launched Netherlands: MA granted MAs granted in the DCPs 02/2016, launched 05/2016 No MAs applied yet Germany: MA
Slide 77: Budesonide/formoterol combination sales in Europe by inhaler device
Budesonide/formoterol combination sales in Europe by inhaler device Total market in 2016: EUR 1.03 billion (-7%) 3% 1% Turbuhaler (AZ) 8% Spiromax (Teva) Easyhaler (Orion) 88% Elpenhaler (Elpen) Source: QuintilesIMS 77 18 May 2017 Orion Capital Markets Day 2017
Slide 78: Budesonide/formoterol dry powder inhaler sales in Europe
Budesonide/formoterol dry powder inhaler sales in Europe Total Gx sales in 2016: EUR 119 million Turbuhaler sales in Europe Gx sales in Europe 1,400 100 1,200 80 1,000 Spiromax EUR million EUR million 60 (Teva) 800 Easyhaler 600 40 (Orion) 400 Elpenhaler 20 (Elpen) 200 0 0 2014 2015 2016 2014 2015 2
Slide 79: Salmeterol/fluticasone combination sales in Europe by inhaler device
Salmeterol/fluticasone combination sales in Europe by inhaler device Total market in 2016: EUR 1.3 billion mnf (-20%) 1% 1% 2% 0% Diskus (GSK) 4% Evohaler (GSK) Sirdupla (Mylan) Poland Diskus generics 32% Forspiro (Sandoz) 60% Elpenhaler (Elpen) Salmeterol/Fluticasone MDI (Cipla) Source: QuintilesIM
Slide 80: Salmeterol/fluticasone combination sales in Europe
Salmeterol/fluticasone combination sales in Europe DPI total market in 2016: 838 m€ (-19%) MDI total market in 2016: 471 m€ (-21%) 2% 2% 1% 3% Diskus (GSK) Evohaler (GSK) 10% Poland Diskus generics Sirdupla (Mylan) Forspiro (Sandoz) Salmeterol/Fluticasone Elpenhaler 89% MDI (Cipla) 93% (Elpen) Sourc
Slide 81: Salmeterol/fluticasone DPI sales in Europe
Salmeterol/fluticasone dry powder inhaler (DPI) sales in Europe DPI Diskus sales in Europe DPI Gx sales in Europe: 1,200 total sales in 2016 EUR 57 million 30 1,000 25 Poland Diskus EUR million 800 EUR million 20 generics 600 15 Forspiro 400 10 (Sandoz) 200 Elpenhaler 5 (Elpen) 0 0 2014 2015 2016 20
Slide 82: Simdax Update
Simdax Update Orion is in the pole position in critical care with significant Share of Voice within the medical society Sales in Europe 2016 EUR 45 million • Partnership with key European societies including (+14.5%) European Society of Cardiology (ESC) and European Society of Intensive Care Medicin
Slide 83: Simdax poses growth opportunities in all European markets
Simdax poses growth opportunities in all European markets and new partner territories No new head-to-head competitors expected in any of the SIMDAX segments during the formulation patent validity period until September 2020 Major investment in marketing and sales with novel multichannel opportunitie
Slide 84: Dexdor Update
Dexdor Update Dexdor sales 20 15 EUR million Dexdor in-market sales in Europe 2016 10 5 +76% Italy Germany 0 +32% Austria Q2Q3Q4Q1Q2Q3Q4Q1Q2Q3Q4Q1Q2Q3Q4Q1 Sweden +42% 2013 2014 2015 2016 17 Spain +112% Other European Sedative Market 2016 +4% +9% Propofol EUR 342 million -1% Midazolam EUR 69 million
Slide 85: Dexdor getting well-established in intensive care unit
Dexdor getting well-established in intensive care unit (ICU) ● Orion is the major sponsor of European wide educational program ESICM-NEXT LIVES accommodating 100 doctors in key hospitals during 2017-2018 ● Multiple international educational events and digital education provided for doctors and nurse
Slide 86: Partnership examples
Partnership examples Prostate cancer Symptoms of Alzheimer’s disease Global partnership for the License agreement for the development & commercialisation development and of darolutamide commercialisation of ORM-12741 • A potent and full AR antagonist – • Alpha-2c adrenoceptor antagonist ORM-12741 Da
Slide 87: R&D pipeline review Part II
R&D pipeline review Part II Christer Nordstedt SVP, Research & Development
Slide 88: ORM-12741
ORM-12741 Alpha-2C adrenoceptor antagonist for symptomatic treatment of Alzheimer’s disease In collaboration with Janssen 88 18 May 2017 Orion Capital Markets Day 2017
Slide 89: ORM-12741
ORM-12741 Baseline ● Highly potent and selective alpha-2C adrenoceptor antagonist ● Rodent models predict beneficial effects on 1 hour after cognition and neuropsychiatric symptoms (NPS) dosing (30 mg) ● Phase 1 studies (healthy subjects) – Possible to administer orally – Well tolerated Quality of M
Slide 90: 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 ● New formulation improving pharmacokinetic (PK) properties of ORM-12741 is used in the ongoing Phase 2a study Objectives To evaluate efficacy of ORM-12741 on agitation & aggression an
Slide 91: ODM-104
ODM-104 New COMT-Inhibitor for Parkinson’s Disease 91 18 May 2017 Orion Capital Markets Day 2017
Slide 92: Treatment of Parkinson's disease with levodopa
Treatment of Parkinson’s disease with levodopa ● Levodopa is the most effective medicine for treating Parkinson’s disease (PD) ● As PD progresses, most people will eventually require the use of levodopa (85% of PD patients receive levodopa) ● However, like all medicines, levodopa is not perfect – sh
Slide 93: Levodopa elimination can be reduced by inhibiting AADC and COMT
Levodopa elimination can be reduced and treatment effect improved by inhibiting breakdown enzymes AADC and COMT 3-OMD (inactive) COMT COMT-i ODM-104 Long- Levodopa Levodopa acting levodop AADC a Carbidopa AADC-i Dopamine Dopamine Body Brain AADC = Aromatic amino acid decarboxylase COMT = Catechol-O-
Slide 94: 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 95: Target indication
Target indication ● The target indication of ODM-104 is Parkinson´s disease with end-of-dose motor fluctuations - the same as the currently approved indications of Comtess®/Comtan® and Stalevo®. Patients on levodopa/AADC inhibitor treatment with or without entacapone can be directly switched to the
Slide 96: ODM-109
ODM-109 Oral levosimendan Best symptomatic treatment for Amyotrophic Lateral Sclerosis (ALS) 96 18 May 2017 Orion Capital Markets Day 2017
Slide 97: Amyotrophic lateral sclerosis - ALS
Amyotrophic lateral sclerosis - ALS ● Orphan disease with prevalence of ~1 patient/25 000 ● Degeneration of motoneuron leads to skeletal muscle weakness including diaphragm ● Causes premature death (3 years median survival time from symptom onset) ● Decreases Quality of Life of both patient and care
Slide 98: Data supporting development of ODM-109 for ALS
Data supporting development of ODM-109 for ALS Levosimendan enhances force generation of diaphragm muscle fibers obtained from a rat model of heart failure and from COPD and non-COPD patients (ex vivo experiments) Levosimendan improves human diaphragm function in healthy subjects in vivo Levosimenda
Slide 99: LEVALS phase II study - levosimendan in ALS patients
LEVALS phase II study - levosimendan in ALS patients ODM-109 (oral levosimendan) ALS I II ● The first phase II study aimed 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
Slide 100: Vision for the future
Vision for the future Orion: a company with the brain power Making Orion capable of delivering novel and muscle of Big Pharma but with the proprietary small molecule therapeutics agility of small biotech and biologics Through internal work and partnering Increase Orion’s visibility within the activi
Slide 101: Competition for academic research groups in Finland
Competition for academic research groups in Finland 2017 www.orion.fi/en/Oriontation100
Slide 102: Financial Targets
Financial Targets Jari Karlson CFO
Slide 103: Orion's strategy — Mission to build well-being
Orion’s strategy — Mission to build well-being 103 18 May 2017 Orion Capital Markets Day 2017
Slide 104: Orion's financial objectives
Orion’s financial objectives Growing net sales more rapidly than ≥ growth of the pharmaceuticals market. Achievement of this objective requires continuous investment in Keeping the equity ratio at least 50%. development of the product portfolio. Distributing an annual dividend that > Maintaining p
Slide 105: Where are we now?
Where are we now? 105 18 May 2017 Orion Capital Markets Day 2017
Slide 106: Steady development despite patent expiries
Steady development despite patent expiries Net sales Operating profit 1,200 8% 350 31% 1,000 300 30% 6% 250 29% EUR million EUR million 800 4% 200 28% 600 2% 150 27% 400 100 26% 200 0% 50 25% 0 -2% 0 24% 2012 2013 2014 2015 2016 2012 2013 2014 2015 2016 Operating profit Parkinson franchise + Precede
Slide 107: …and despite major change in product portfolio
…and despite major change in product portfolio Sales by business 2011 Sales by business 2016 Net sales 1,200 3% 5% 4% 5% 5% 4% 1,000 7% EUR million 33% 800 7% 44% 600 400 35% 47% 200 0 Proprietary Products Specialty Products 2012 2013 2014 2015 2016 Animal Health Fermion Contract manufacturing & oth
Slide 108: Sales in Finland continue to be important, but own sales network covers most of Europe
Sales in Finland continue to be important, but own sales network covers today most of Europe By market area in 2016 Orion’s sales network 13% Finland 32% 8% Scandinavia Other Europe North America ROW 31% 16% 108 18 May 2017 Orion Capital Markets Day 2017
Slide 109: Steady sales growth for Specialty Products
Steady sales growth for Specialty Products 600 20% Sales in 2016 8% 450 15% 13% EUR million 21% 12% 300 10% 16% 59% 71% 150 5% 0 0% Gx OTC Biosimilars 2012 2013 2014 2015 2016 Finland Scandinavia Net sales Growth, % Eastern Europe & Russia ROW 109 18 May 2017 Orion Capital Markets Day 2017
Slide 110: Proprietary Products - portfolio is today more balanced
Proprietary Products - portfolio is today more balanced Net sales ● Mainly Orion in-house developed prescription 450 drugs with valid product protection 400 Other ● Global sales and R&D partner networks 350 Simdax 300 EUR million Key drivers for business 250 Easyhaler 200 Easyhaler, Dexdor, & Simd
Slide 111: SG&A expenses in good control
SG&A expenses in good control SG&A expenses Sales&marketing expenses 250 27% 1,200 34% 200 26% 1,000 32% EUR million EUR million 800 30% 150 25% 600 28% 100 24% 400 26% 50 23% 200 24% 0 22% 0 22% 2011 2012 2013 2014 2015 2016 2011 2012 2013 2014 2015 2016 Administration Net Sales outside Europe Sale
Slide 112: Financial position
Financial position EUR million 12/16 12/15 Change % EUR million 12/16 12/15 Change % Non-current assets 372 373 -0.5% Equity total 641 595 +8% Interest-bearing non- Inventories 228 206 +11% current liabilities 150 178 -16% Trade receivables 200 192 +4% Non-current liabilities 191 219 -13% Other rece
Slide 113: Good control of capital expenditure, but building for the future
Good control of capital expenditure, but building for the future - Capex has exceeded depreciations Orion Capex 80 70 Intangible assets 60 EUR million 50 40 Property, plant and equipment 30 20 Depreciation, 10 amortisation and impairment 0 2011 2012 2013 2014 2015 2016 113 18 May 2017 Orion Capital
Slide 114: Management of Net working capital
Management of Net working capital - Challenge: Change in business portfolio towards generics % of net sales EUR million 30% 300 20% 200 10% 100 0% 0 -10% -100 -20% -200 -30% -300 2011 2012 2013 2014 2015 2016 2011 2012 2013 2014 2015 2016 Receivables Inventories Short-term non-interest bearing liabi
Slide 115: Dividend distribution
Dividend distribution 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 1.60 € 100% 1.50 € 95% Repayment of capital per share 1.40 €
Slide 116: Key ratios have been at very good level for years
Key ratios have been at very good level for years - Dividends and seasonality in profitability however have impact At the end of Year At the end of Q1 70% 70% 65% 65% 60% 60% 55% 55% 50% 50% 45% 45% 40% 40% 35% 35% 30% 30% 2011 2012 2013 2014 2015 2016 2011 2012 2013 2014 2015 2016 Equity ratio ROCE
Slide 117: Key drivers for achieving financial targets
Key drivers for achieving financial targets 117 18 May 2017 Orion Capital Markets Day 2017
Slide 118: Opportunities and challenges
Opportunities and challenges Proprietary Specialty Orion Regulation Animal Health Diagnostica Products Products Competition R&D risks Easyhaler New product Dexdor launches R&D QuikRead Orion Biosimilars Pipeline GenRead Simdax R&D Pipeline 118 18 May 2017 Orion Capital Markets Day 2017
Slide 119: Current products/markets drive mid term development
Current products/markets drive Mid term development - e.g. continued growth of Easyhalers & market position in Finland Quaterly sales of Easyhalers Largest pharmaceutical companies in 18 Finland in 2016 16 350 14 299 300 EUR million 12 EUR million 10 250 8 200 157 6 150 102 105 122 4 100 2 50 0 0 Q1
Slide 120: Long term growth opportunities via R&D collaboration
Long term growth opportunities via R&D collaboration Late stage Research Early development development Target Candidate Phase I Phase II Phase III Hit to Lead Lead identification selection, generation optimisation and validation preclinical development 12–24 mo 18–36 mo 8–24 mo 12–24 mo 12–14 mo 12–
Slide 121: Mid term growth drivers from pipeline
Mid term growth drivers from pipeline Project Indication PHASE Registration Bioequivalence Easyhaler® salmeterol-fluticasone Asthma, COPD Registration study Darolutamide (ODM-201) 1) Prostate cancer (nmCRPC) I II III Darolutamide (ODM-201) 1) Prostate cancer (mHSPC) I II III Levosimendan 2) Low Card
Slide 122: Longer term pipeline opportunities
Longer term pipeline opportunities Project Indication PHASE Registration ODM-109 (oral levosimendan) ALS I II ORM-12741 (alpha-2c adrenoceptor antagonist) 3) Alzheimer’s disease I IIa ODM-104 (more effective COMT inhibitor) Parkinson’s disease I II ODM-203 (targeted FGFR+VEGFR inhibitor) Solid tumou
Slide 123: TOP Supply Chain
Quality and Compliance TOP Supply Chain Robust compliance level with justified Orion approach Culture: quality on the shop floor Vision 2018: The Right first time execution most competitive, Eliminate redundant work demand-driven supply chain. Zero work accidents Maximization of value for the custom
Slide 124: SG&A drivers
SG&A drivers Continuous development of Administration and support sales operations functions mostly centralized • Competence development • Active alignment of sales • Information management, legal, resources & processes and etc. mostly in Finland product portfolio • Continuous process and system • U
Slide 125: Capital expenditure & Net working capital
Capital expenditure & Net working capital Large product portfolio and supplier network has made and Timing of capital expenditure will make management of net has been actively managed working capital challenging • To allow sufficient resources for • Number of SKU’s has though been good project execu
Slide 126: Equity structure and Profit distribution
Equity structure and Profit distribution Orion Orion Of these 218 31 Dec 2016 (EUR million) Corporation Group million was distributed in Share capital 92.2 92.2 March 2017 Reserves 1.4 4.6 left EUR Retained earnings 0.71/share Orion Corporation 317.3 317.3 IFRS and Subsidiaries 94.5 consolidation
Slide 127: Summary
Summary - Actions are driven by financial objectives Increasing net sales EBIT > 25% of net sales Equity ratio ≥ 50% – Maximize value of – Sales growth – Good profitability current products – Management of cost – Management of working – R&D pipeline structure capital development – Management of – Op
Slide 128: Q&A
Q&A 128 18 May 2017 Orion Capital Markets Day 2017