Orion Oyj Class A · OMXHEX:ORNAV
Orion Oyj Class A — Investor Presentation (October 2020)
67 slides from Orion Oyj Class A's investor presentation, October 2020
Slide 1: Orion Investor Presentation
Orion Investor Presentation
Slide 2: 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 3: Content
Content 1) Orion in brief 2) Highlights of 1-9/2020 3) R&D 4) Responsibility 5) Appendices 6) Financial calendar Investor Presentation © Orion Corporation 3
Slide 4: Orion in brief
Orion in brief
Slide 5: Key messages
Key messages 1 Orion develops, 5 Strong position in 3 Growth targeted manufactures and through new the Nordic markets human in-house developed generics market. and animal drugs. pharmaceuticals and APIs. Products marketed in >100 countries. Core therapy areas 4 6 Strong 22 4 Balanced business model:
Slide 6: Orion at a glance (2019 figures)
Orion at a glance (2019 figures) Net sales Sales by business Sales by market area 1,051 MEUR Operating profit 7% 12% 8% 253 MEUR 39% 10% 29% Personnel 3,265 R&D investments 46% 119 MEUR 32% 17% 6 production sites in Finland Proprietary Products Finland Specialty Products Scandinavia Own sales unit A
Slide 7: Orion's development
Orion’s development Net sales Operating profit EUR million EUR million 1 200 12% 350 35% 1 000 9% 300 30% 800 6% 250 25% 200 20% 600 3% 150 15% 400 0% 100 10% 200 -3% 50 5% 0 -6% 0 0% 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2
Slide 8: Orion's businesses
Orion’s businesses Fermion & Contract Proprietary Products Specialty Products Animal Health manufacturing In-house developed drugs Generic prescription drugs, Own animal drugs for global Active pharmaceutical and other drugs with valid OTC and non-medicinal markets. Other drugs and ingredients (APIs
Slide 9: Outlook for 2020
Outlook for 2020 (provided on 19 October 2020) Net sales Orion estimates that in 2020 net sales will be at a similar level as in 2019 or slightly higher than in 2019 (net sales in 2019 were EUR 1,051 million). Operating profit Operating profit is estimated to be higher or clearly higher than in 2019
Slide 10: Orion's strategic growth target and financial objectives
Orion’s strategic growth target and financial objectives Strategic growth target: Net sales EUR 1.5 billion in 2025 Financial objectives: Growing net sales more rapidly ≥ than growth of the pharma market. Achievement of this objective requires continuous investment in development of the product Ke
Slide 11: Key elements of Orion's growth
Key elements of Orion’s growth Animal Support Proprietary Health growth Products Growth drivers and R&D APIs for R&D and Fermion Proprietary Generate cash Products flow to fund Specialty Products growth Less vulnerable investments Defensive to Support growth industry macroeconomic volatility Investo
Slide 12: New Proprietary Products and R&D pipeline as growth drivers
New Proprietary Products and R&D pipeline as growth drivers – after ODM-109 failure more emphasis on other opportunities OPPORTUNITIES THREATS/CHALLENGES Darolutamide Generic mHSPC* competition Easyhaler® tiotropium* ODM-109* Animal Health R&D* Pricing pressure In-licensing and product acquisitions
Slide 13: Orion's key clinical drug development projects
Orion's key clinical drug development projects Project Indication Phase Registration Easyhaler® tiotropium COPD Bioequivalence study Darolutamide 1) Prostate cancer (mHSPC) I II III ODM-203 (targeted FGFR+VEGFR Solid tumours I II inhibitor) 2) ODM-207 (BET protein inhibitor) 2) Cancer I ODM-208 (CYP
Slide 14: Orion had ~67,800 shareholders on 30 September 2020
Orion had ~67,800 shareholders on 30 September 2020 By number of shares By number of votes Households (Finnish 5% 3% retail) 2% 9% 7% 6% Non-Finnish holders and nominee-registered 6% 39% Private corporations 12% 61% Public sector 10% Non-profit institutions 41% Financial and insurance corporations I
Slide 15: Largest shareholders by votes and shares on 30 September 2020
Largest shareholders by votes and shares on 30 September 2020 # Shareholder % of votes Number of votes # Shareholder % of shares Number of shares 1 Erkki Etola and companies 6.19 50,200,000 1 Ilmarinen Mutual Pension Insurance Company 2.57 3,619,845 2 Maa- ja vesitekniikan tuki r.y. and companies 5.
Slide 16: Orion B share performance January 2016 – September 2020
Orion B share performance January 2016 – September 2020 Index 31/12/2015=100 65 195 60 180 55 165 Share price, EUR 150 50 45 Orion B 135 Index Orion B total return 120 40 Europe/Pharmaceutical 105 35 OMXH-portfolio 90 30 Orion B share price 75 25 60 20 31-Dec-15 31-Mar-16 30-Jun-16 30-Sep-16 31-Dec-
Slide 17: Highlights in January-September 2020
Highlights in January-September 2020
Slide 18: Orion is prepared for the second wave of COVID-19 pandemic
Orion is prepared for the second wave of COVID-19 pandemic 1 Orion is prepared for the second wave of the COVID-19 by seeking to ensure the 3 REFALS study (ODM-109) did not meet its endpoints. continuity of the production and the availability of pharmaceutical products by eg. 4 increasing inventorie
Slide 19: COVID-19 pandemic impacts on Orion
COVID-19 pandemic impacts on Orion The most important thing is to take care of the health and safety of employees, the continuity of production and patient safety in ongoing clinical trials. Disruptions in the global supply The March demand spike impact chains possible but the risk of of Gx and OTC
Slide 20: Key figures 1−9/2020
Key figures 1−9/2020 Net sales Operating profit Operating profit Cash flow per share margin before financial items 823 246 30% 1.52 MEUR (776) MEUR (198) (25%) EUR (1.28) +6% +24% +18% Investor Presentation © Orion Corporation 20
Slide 21: Development of net sales in 1-9/2020 vs. 1-9/2019
Development of net sales in 1-9/2020 vs. 1-9/2019 9 -8 21 823 11 2 13 776 -11 10 * Nubeqa® product sales & royalty ** Royalties & milestones (without Nubeqa® royalties) Investor Presentation © Orion Corporation 21
Slide 22: Development of operating profit in 1-9/2020 vs. 1-9/2019
Development of operating profit in 1-9/2020 vs. 1-9/2019 19 -10 246 -4 2 6 34 198 * Product & service sales without sales margin and product mix change and exchange rate effect *** Exchange rate effect on gross margin ** Product sales margin and product mix change but without exchange rate effect In
Slide 23: Geographical breakdown and development of net sales
Geographical breakdown and development of net sales 1-9/2020 MEUR 1-9/2020 1-9/2019 13% 350 29% +14% 300 8% +3% 250 281 247 233 226 200 +3% 150 +27% -24% 134 130 16% 100 109 34% 88 86 50 67 Finland Scandinavia 0 Other Europe North America ROW Investor Presentation © Orion Corporation 23
Slide 24: All units showed growth
All units showed growth 1−9/2020 1−9/2019 1-9/2020 MEUR +6% 450 +8% 7% 400 372 8% 349 331 350 308 300 40% 250 200 +7% +4% 150 45% 100 69 64 56 54 50 0 Proprietary Products Specialty Proprietary Animal Fermion and Specialty Products Products Products Health Contract Manufacturing Animal Health Fermio
Slide 25: Best-selling pharmaceuticals 1−9/2020
Best-selling pharmaceuticals 1−9/2020 Net sales Change vs. . Indication EUR million 1−9/2019 1. Asthma, COPD 88 +17% 2. Parkinson’s disease 80 +14% 3. Acute heart failure 49 -1% 4. Intensive care sedative 41 -10% 5. Animal sedatives 29 +6% 6. Inflammatory pain 18 -3% 7. Divina series Menopausal symp
Slide 26: Proprietary Products
Proprietary Products
Slide 27: Easyhaler® franchise and Parkinson's franchise growth drivers
Easyhaler® franchise and Parkinson’s franchise growth drivers Proprietary Products MEUR +17% +9% sales split 1-9/2020 100 +14% 88 90 80 22% 75 24% 80 70 73 -1% -10% 67 70 60 49 49 46 50 41 40 30 15% 20 10 27% 0 12% Easyhaler® Parkinson's Simdax® Dexdor® Others Parkinson's Easyhaler® franchise franch
Slide 28: Easyhaler® sales +17%
Easyhaler® sales +17% 1-9/2020 Budesonide-formoterol Easyhaler® MEUR 55 (44) +24% 40 1-9/2020 Other Easyhaler® products MEUR 33 (31) +6% 30 Sales, MEUR 20 10 0 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 2015 2016 2017 2018 2019 2020 Other Budesonide-formoterol Easyhaler® In
Slide 29: Parkinson's franchise sales +14%
Parkinson’s franchise sales +14% 1-9/2020 Own sales MEUR 39 (33) +16% 50 45 1-9/2020 Deliveries to partners MEUR 42 (37) +12% 40 35 Sales, MEUR 30 25 20 15 10 5 0 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 2015 2016 2017 2018 2019 2020 Orion own sales Deliveries to partners
Slide 30: Dexdor® and Simdax®
Dexdor® and Simdax® 1-9/2020 Dexdor® MEUR 41 (46) -10 % 1-9/2020 Simdax® MEUR 49 (49) -1 % 20 20 15 15 10 10 5 5 0 0 2015 2016 2017 2018 2019 2020 2015 2016 2017 2018 2019 2020 Investor Presentation © Orion Corporation 30
Slide 31: Specialty Products
Specialty Products
Slide 32: Specialty Products: COVID-19 related demand spike levelled off further
Specialty Products: COVID-19 related demand spike levelled off further Development of net sales Net sales by region Net sales by products 1−9/2020 1−9/2020 MEUR +3% 4% 250 15% 205 199 24% 200 14% 150 -7% +8% 55% 100 61 65 52 48 50 16% 72% 0 Finland Scandinavia Eastern Finland Generic drugs Europe &
Slide 33: In Finland, market for reference priced prescription drugs levelled off
In Finland, market for reference priced prescription drugs levelled off after demand spike in March The market for reference priced The sales of Orion's reference prescription drugs in Finland priced prescription drugs (1−9/2020) in Finland MEUR 340 (339) MEUR 84 (83) Market development Orion’s deve
Slide 34: Orion is strong in home market Finland
Orion is strong in home market Finland Human pharma market in Finland 1−9/2020 Reference Self-care Medicinal and non-medicinal products priced products in hospital and pharmacy channels: EUR 2,121 million prescription Orion market share in MEUR drugs pharmacy 250 229 Orion market share in 200 76 pha
Slide 35: Orion's key business targets in 2020
Orion's key business targets in 2020 Commercialisation of darolutamide in • First commercial sales of Europe. ARASENS trial (metastatic prostate darolutamide in Japan and the EU. 1. cancer) continues in order to expand the • Fully recruited ARASENS trial indication for the molecule. estimated to com
Slide 36: Orion's key business targets in 2020
Orion's key business targets in 2020 Strengthening Orion’s position as the most • Orion is a clear market leader significant provider of generic drugs in both in self-care products and 3. Finland. Competitive product portfolio in reference priced prescription Specialty Products and strengthening of
Slide 37: Orion's preparedness for the second wave of COVID-19
Orion’s preparedness for the second wave of COVID-19 MATERIAL THEMES OF SUSTAINABILITY Ensuring patient safety and reliable supply of Responsibility for employees, the environment medications and the ethics and transparency of operations • Ensuring reliable supply of medications is the most • Taking
Slide 38: Research and development
Research and development
Slide 39: Focus areas of Orion's R&D
Focus areas of Orion’s R&D Proprietary products Animal Health Fermion • Central nervous system • Orion utilises the • APIs for Orion’s • Oncology R&D of proprietary proprietary products • Respiratory products to develop • Generic APIs (Easyhaler® product family) new medicines for • Contract developm
Slide 40: Proprietary human pharmaceuticals developed by Orion
Proprietary human pharmaceuticals developed by Orion Fareston® Investor Presentation © Orion Corporation 40
Slide 41: Together we can achieve more in R&D
Together we can achieve more in R&D 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 development 8‒24 mo. 12‒24 mo. 18‒36 mo. 12‒24 mo. 12‒14 mo. 12‒36 mo. 18‒48
Slide 42: Orion's key clinical drug development projects
Orion's key clinical drug development projects Project Indication Phase Registration Easyhaler® tiotropium COPD Bioequivalence study Darolutamide 1) Prostate cancer (mHSPC) I II III ODM-203 (targeted FGFR+VEGFR Solid tumours I II inhibitor) 2) ODM-207 (BET protein inhibitor) 2) Cancer I ODM-208 (CYP
Slide 43: Key findings of ARAMIS phase III trial
Key findings of ARAMIS phase III trial: Darolutamide shows substantial efficacy and favourable safety profile Metastasis free Time to pain survival1 (months) progression1 (months) ● Darolutamide significantly reduced risk of death by 31% (HR=0.69, 95% CI 0.53- 40.4 40.3 HR=0.41 HR=0.65 0.88; p=0.003
Slide 44: ARASENS trial aims to expand the indication of darolutamide
ARASENS trial aims to expand the indication of darolutamide to metastatic hormone-sensitive prostate cancer (mHSPC) Treatment Primary endpoint Estimated Darolutamide + Fully recruited completion in ADT + six cycles Overall Survival 2021e of docetaxel Secondary endpoints: Time to castration resistanc
Slide 45: Financial impacts of darolutamide and regulatory update
Financial impacts of darolutamide and regulatory update ● Bayer has the right to commercialise ● Darolutamide has been approved for the darolutamide globally. treatment of nmCRPC eg. in ● Orion will co-promote in several European ● USA – July 2019 countries. Orion will manufacture the product. ● Jap
Slide 46: Until recently, no effective treatment options for CRPC patients
Until recently, there have been no effective treatment options for CRPC patients who have rising Prostate-Specific Antigen (PSA) levels while on ADT and no detectable metastases Non-metastatic CRPC Investor Presentation © Orion Corporation 46
Slide 47: Global prostate cancer estimates (2018)
Global prostate cancer estimates (2018) 70 1 2nd 35th 5 most commonly leading cause of diagnosed death from cancer malignancy in men 50 60 70 80 in men worldwide 50 60 70 80 21.2 358,000 4 650+ million men died from Mainly affects men diagnosed with the disease over 50, the risk prostate cancer incr
Slide 48: REFALS did not reach its pre-specified endpoints
REFALS did not reach its pre-specified endpoints ● The primary endpoint of the trial was to show a statistically significant difference between levosimendan and placebo in slow vital capacity (SVC) in supine position at 12 weeks compared to the baseline ● An important secondary endpoint was to show
Slide 49: CYP11A1 inhibitors (ODM-208 & ODM-209)
CYP11A1 inhibitors (ODM-208 & ODM-209) First-in-class compounds Potential indications ODM-208 & ODM-209 prevent Prostate Breast the synthesis of ALL steroid hormones Cancer Cancer Glucocorticoids and mineralocorticoids need to Endometrial cancer of the uterus be replaced during therapy Adrenocortica
Slide 50: Orion investigates CYP11A1 inhibitors in two first-in-human Phase I-II trials
Orion investigates CYP11A1 inhibitors in two first-in-human Phase I-II trials The CYPIDES trial (ODM-208) ● Steroid hormones stimulate the growth of hormonally regulated cancers, such as most • Advanced prostate cancer that prostate and breast cancers. progressed during one or more novel hormonal th
Slide 51: Sustainability is built into Orion's mission
Sustainability is built into Orion’s mission
Slide 52: Key themes of corporate responsibility
Key themes of corporate responsibility Responsibility Ensure patient for the environment Ethics and safety and – production according Taking care of transparency of availability of to the principles Orionees operations medicines of sustainable development Investor Presentation © Orion Corporation 52
Slide 53: This is how we are building well-being responsibly
This is how we are building well-being responsibly WE PRODUCE 1/3 OF THE GLOBAL SUPPLY OF ~200-300 NUMBER OF AUDITS CUSTOMER METHOTREXATE ANNUALLY COMPLAINTS IN 2019 76 (ppm) ORION’S FOCUS ON QUALITY THROUGHOUT THE LIFECYCLE PATIENT R&D RAW MANUFACTURING PACKING DELIVERY SALES PATIENT RECYCLING NEED
Slide 54: Appendices
Appendices
Slide 55: Track record vs. financial objectives
Track record vs. financial objectives Net sales Operating profit Dividend 35% 1,60 1 200 12% 300 30% 1,55 1 000 9% 250 1,50 25% 800 6% 200 1,45 20% 1,40 600 3% 150 15% 1,35 400 0% 100 10% 1,30 1,25 200 -3% 50 5% 1,20 0 -6% 0 0% 1,15 2016* 2012 2013 2014 2015 2017 2018 2019 2012 2017 2013 2014 2015 2
Slide 56: Key figures by quarter
Key figures by quarter Net sales, EUR million Operating profit, EUR million 1200 400 900 279 266 264 274 Q4 300 59 Q4 259 250 71 55 600 242 222 284 Q3 200 92 69 65 Q3 55 45 273 261 292 91 96 300 246 252 Q2 100 84 71 70 Q2 52 262 266 247 241 280 80 88 70 55 84 0 Q1 0 Q1 16* 17 18 19 20 16* 17 18 19 2
Slide 57: Key figures
Key figures 1-9/ Change vs. Orion’s key figures 2015 2016 2017 2018 2019 2020 1-9/2019 Net sales, EUR million 1,015.6 1,073.5 1,033.6 977.5 1,051.0 882.7 +6.0% EBITDA 308,3 355,2 323,6 293.9 308.9 288.7 +20.6% Operating profit, EUR million 266.6 314.6 284.1 252.8 252.8 245.9 +24.3% Profit before tax
Slide 58: Income statement
Income statement Change vs. Formation of profits, EUR million 2015 2016 2017 2018 2019 1-9/2020 1-9/2019 Net sales 1,015.6 1,073.5 1,033.6 977.5 1,051.0 822.7 +6.0% Cost of goods sold -405.8 -421.7 -417.6 -387.9 -417.6 -311.4 +2.2% Gross profit 609.8 651.8 616.0 589.6 633.4 511.3 +8.4% Other operati
Slide 59: Royalties and milestones
Royalties and milestones Includes significant part of EUR 50 million 80 darolutamide collaboration signing fee from Bayer Includes EUR 28 million milestones from Bayer for the first commercial sales of darolutamide in EU and JPN 70 Includes EUR 45 million milestone from Bayer for the 60 first commer
Slide 60: Development of Proprietary Products net sales
Development of Proprietary Products net sales 450 400 24 Other 26 67 350 44 56 18 46 26 25 Simdax® 27 20 59 300 13 29 47 56 57 68 EUR million 48 25 51 250 35 Easyhaler® 59 51 64 77 90 35 105 200 Dexdor® 30 45 57 150 18 64 63 249 20 57 206 25 26 Precedex® 100 170 138 124 50 104 100 98 Stalevo®/Comtes
Slide 61: Financial position
Financial position EUR million 9/20 9/19 Change % EUR million 9/20 9/19 Change % Non-current assets total 417.2 409.9 +1.8% Inventories 254.6 229.3 +11.0% Equity total 761.0 712.1 +6.9% Interest-bearing non-current Trade receivables 150.2 176.6 -15.0% liabilities 105.4 5.1 Other receivables 30.0 22.
Slide 62: Development of capital expenditure
Development of capital expenditure Orion Capex, EUR million 90 80 70 60 Property, plant and equipment 50 40 Intangible assets 30 20 Depreciation, amortisation and 10 impairment 0 Investor Presentation © Orion Corporation 62
Slide 63: Development of net working capital
Development of net working capital % of net sales EUR million 40% 400 30% 300 20% 200 10% 100 0% 0 -10% -100 -20% -200 -30% -300 2013 2014 2015 2016 2017 2018 2019 2020 2013 2014 2015 2016 2017 2018 2019 2020 Receivables Receivables Inventories Inventories Short-term non-interest bearing liabilities
Slide 64: Dividend distribution policy and dividend history
Dividend distribution policy and dividend history • 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. EUR Dividend distribution history 1,75 0.20 110% 0.12 105% 1,
Slide 65: Easyhaler® - diverse treatment options for asthma and COPD
Easyhaler® - diverse treatment options for asthma and COPD by utilising the same inhaler technology ● Easyhaler® is a dry-powder inhaler developed in-house ● Orion has developed Easyhaler®-adapted dry powder formulations of several well-known generic active substances: – salbutamol, beclometasone, b
Slide 66: Orion calendar
Orion calendar Financial Statement Release for 2020 9/2/2021 AGM planned to be held 25/3/2021 Interim Report 1-3/2021 27/4/2021 Half-Year Financial Report 19/7/2021 Interim Report 1-9/2021 20/10/2021
Slide 67: Investor Relations
Investor Relations Jari Karlson CFO jari.karlson@orion.fi +358 10 426 2883 Tuukka Hirvonen Head of Investor Relations tuukka.Hirvonen@orion.fi +358 10 426 2721 Heidi Ahti Executive Assistant (Investor meeting requests) heidi.ahti@orion.fi +358 10 426 2169 www.orion.fi/EN/Investors twitter.com/OrionC