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 1-3/2020 3) R&D 4) Sustainability 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, 3 5 Growth targeted Strong position in 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 24 April 2020) Net sales Orion estimates that in 2020 net sales will be at a similar level as in 2019 (net sales in 2019 were EUR 1,051 million). Operating profit Operating profit is estimated to be at a similar level as in 2019 (in 2019 operating profit was EUR 253 mil
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 OPPORTUNITIES THREATS/CHALLENGES Generic Darolutamide competition mHSPC* Easyhaler® tiotropium* ODM-109* Animal Health R&D* Pricing pressure In-licensing and product acquisitions Tightening competition Expansion to new geographic market are
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 (nmCRPC) I II III Registration 3) Darolutamide 1) Prostate cancer (mHSPC) I II III ODM-109 (oral levosimendan) ALS I II III ODM-203 (ta
Slide 14: Orion had ~67,000 shareholders on 31 March 2020
Orion had ~67,000 shareholders on 31 March 2020 By number of shares By number of votes Households (Finnish 5% 3% 0% retail) 4% 0% 8% 7% Non-Finnish holders and nominee-registered 6% 6% Private corporations 39% 13% Public sector 59% Non-profit institutions 9% 39% Financial and insurance corporations
Slide 15: Largest shareholders by votes and shares on 31 March 2020
Largest shareholders by votes and shares on 31 March 2020 # Shareholder % of votes Number of votes # Shareholder % of shares Number of shares 1 Erkki Etola and companies 6.08 50,300,000 1 Ilmarinen Mutual Pension Insurance Company 2.44 3,449,277 2 Maa- ja vesitekniikan tuki r.y. and companies 5.04 4
Slide 16: Orion B share performance January 2016 – March 2020
Orion B share performance January 2016 – March 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-16 3
Slide 17: Highlights in January-March 2020
Highlights in January-March 2020
Slide 18: COVID-19 increased demand and challenges
COVID-19 increased demand and challenges 1 Net sales grew clearly due to strongly increased demand of medicines caused by the COVID-19 pandemia. 3 Darolutamide received marketing authorisations in Japan and the EU. The growth was partly due to hoarding and inventory increases, partly due to 4 increa
Slide 19: COVID-19 pandemia impacts on Orion
COVID-19 pandemia 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. Strong demand spike of generic prescription The global supply chains of pharmaceuticals drugs and OTC product
Slide 20: Key figures 1−3/2020
Key figures 1−3/2020 Net sales Operating profit Operating profit Cash flow per share margin before financial items 280 84 30% 0.34 MEUR (241) MEUR (55) (23%) EUR (0.40) +16% +53% -15% Investor Presentation © Orion Corporation 20
Slide 21: Development of net sales and operating profit
Development of net sales and operating profit Net sales Operating profit 11 -6.6 -0.7 2.3 -3.6 84 22 -1 280 27 2 8 7 9 55 241 -6 -2 * Product & service sales without sales margin and product mix change and exchange rate effect *** Exchange rate effect on gross margin ** Product sales margin and prod
Slide 22: Geographical breakdown and development of net sales
Geographical breakdown and development of net sales 1-3/2020 MEUR 1-3/2020 1-3/2019 13% 100 +5% +13% 30% 90 8% 80 84 87 83 70 74 +16% 60 50 +37% 51 40 44 +56% 30 36 31% 18% 20 26 22 10 14 Finland Scandinavia 0 Other Europe North America ROW Investor Presentation © Orion Corporation 22
Slide 23: Proprietary and Specialty Products showed strong growth
Proprietary and Specialty Products showed strong growth 1−3/2020 1−3/2019 1-3/2020 MEUR +21% 160 5% 135 +24% 140 8% 120 111 111 100 89 39% 80 +12% -18% 60 48 % 40 23 21 15 18 20 0 Proprietary Products Specialty Proprietary Animal Fermion and Specialty Products Products Products Health Contract Manuf
Slide 24: Best-selling pharmaceuticals 1−3/2020
Best-selling pharmaceuticals 1−3/2020 Net sales Change vs. . Indication EUR million 1−3/2019 1. Asthma, COPD 35 +33% 2. Parkinson’s disease 28 +33% 3. Acute heart failure 19 +17% 4. Intensive care sedative 17 -14% 5. Animal sedatives 9 -8% 6. Inflammatory pain 8 +37% 7. Divina-sarja Menopausal sympt
Slide 25: Proprietary Products
Proprietary Products
Slide 26: Strong growth - Dexdor® declined clearly less than expected
Strong growth - Dexdor® declined clearly less than expected Proprietary Products MEUR +33% sales split 1-3/2019 40 +33% 35 12% 35 25% 30 28 +17% -14% 26 25 21 19 19 20 17 17 17% 15 10 5 15% 31% 0 Easyhaler® Parkinson's Simdax® Dexdor® Parkinson's Easyhaler® franchise franchise Dexdor® Simdax® 1−3/20
Slide 27: Easyhaler® sales +33%
Easyhaler® sales +33% 1-3/2020 Budesonide-formoterol Easyhaler® MEUR 20 (15) +31% 40 1-3/2020 Other Easyhaler® products MEUR 14 (11) +36% 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 2015 2016 2017 2018 2019 20 Other Budesonide-formoterol Easyhaler® Investor
Slide 28: Parkinson’s franchise sales +33%
Parkinson’s franchise sales +33% 1-3/2020 Own sales MEUR 13 (8) +65% 50 45 1-3/2020 Deliveries to partners MEUR 15 (13) +14% 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 2015 2016 2017 2018 2019 20 Orion own sales Deliveries to partners Investor
Slide 29: Dexdor® and Simdax®
Dexdor® and Simdax® 1-3/2020 Dexdor® MEUR 17 (19) -14 % 1-3/2020 Simdax® MEUR 19 (17) +17 % 20 20 15 15 10 10 5 5 0 0 Q1 Q1 2015 2016 2017 2018 2019 20 2015 2016 2017 2018 2019 20 Investor Presentation © Orion Corporation 29
Slide 30: Specialty Products
Specialty Products
Slide 31: Specialty Products: COVID-19 clearly increased demand
Specialty Products: COVID-19 clearly increased demand Development of net sales Net sales by region Net sales by products 1−3/2020 1−3/2020 MEUR +14% 4% 80 74 10% 70 65 15% 27% 60 50 +19% +51% 40 55% 30 26 22 21 20 14 20% 69% 10 0 Finland Scandinavia Eastern Finland Generic drugs Europe & Scandinavia
Slide 32: In Finland, market of reference priced prescription drugs turned to growth
In Finland, market of reference priced prescription drugs turned to growth due to strong demand in March The market of reference priced The sales of Orion's reference prescription drugs in Finland priced prescription drugs (1−3/2020) in Finland MEUR 110 (102) MEUR 30 (27) Market development Orionin’
Slide 33: Orion is strong in home market Finland
Orion is strong in home market Finland Human pharma market in Finland 1−3/2020 Reference Self-care Medicinal and non-medicinal products priced products in hospital and pharmacy channels: EUR 750 million prescription Orion market share in MEUR drugs pharmacy 90 86 Orion market share in 80 70 30 pharm
Slide 34: Orion's key business targets in 2020
Orion's key business targets in 2020 • Marketing authorisation received in Commercialisation of darolutamide in Japan and EU for the treatment of Europe. ARASENS trial (metastatic prostate non-metastatic castration-resistant 1. cancer) continues in order to expand the prostate cancer. indication for
Slide 35: Orion's key business targets in 2020
Orion's key business targets in 2020 Strengthening Orion’s position as the most • Orion grew faster than the significant provider of generic drugs in market and is a clear market 3. Finland. Competitive product portfolio in leader both in self-care Specialty Products and strengthening of products an
Slide 36: Patient safety and reliable supply of medications are priorities during COVID-19
Patient safety and reliable supply of medications are priorities also during COVID-19 pandemic MATERIAL THEMES OF SUSTAINABILITY Ensuring patient safety and reliable supply of Responsibility for the environment, employees medications and the ethics and transparency of operations • Ensuring reliable
Slide 37: Research and development
Research and development
Slide 38: 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 to Orion’s • Oncology R&D of proprietary proprietary products • Respiratory products to develop • Generic APIs (Easyhaler® product family) new medicines for • Contract developme
Slide 39: Proprietary human pharmaceuticals developed by Orion
Proprietary human pharmaceuticals developed by Orion Fareston® Investor Presentation © Orion Corporation 39
Slide 40: 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 41: 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 (nmCRPC) I II III Registration 3) Darolutamide 1) Prostate cancer (mHSPC) I II III ODM-109 (oral levosimendan) ALS I II III ODM-203 (ta
Slide 42: Key findings of ARAMIS phase III trial: Darolutamide
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 showed a statistically significant improvement in overall 40.4 40.3 HR=0.41 HR=0.65 survival (OS). Detail
Slide 43: ARASENS trial aims to expand the indication of darolutamide to mHSPC
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 2022e of docetaxel Secondary endpoints: Time to castration resistanc
Slide 44: Financial impacts of darolutamide and regulatory update
Financial impacts of darolutamide and regulatory update ● Bayer has the right to commercialize ● 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 45: 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 21
Slide 46: 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 47: ODM-109: Oral levosimendan for ALS
ODM-109: Oral levosimendan for ALS By enhancing respiratory muscle function in ALS patients, orally administered levosimendan can help maintain breathing capacity and benefit overall functioning of ALS patients. Levosimendan has been used (Simdax®) for the treatment of acute decompensated heart fail
Slide 48: REFALS patient recruitment completed
REFALS patient recruitment completed 104 ALS centres in 14 countries • REFALS is an Orion study Primary endpoints • 1st patient randomised July 2018 • 12 weeks: Slow vital capacity • Last patient randomisation in July 2019 (Breathing – Study results expected in H2 2020 capacity compared • Number of
Slide 49: ALS (Amyotrophic lateral sclerosis) as a rare disease
ALS (Amyotrophic lateral sclerosis) as a rare disease 1−2∕ ~16,000 ~12,500 ~450−500 100,000 Patients Incidence Patients Patients in the US in Europe in Finland Investor Presentation © Orion Corporation 49
Slide 50: 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 51: 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 52: Sustainability is built into Orion’s mission
Sustainability is built into Orion’s mission
Slide 53: 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 53
Slide 54: 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 55: Appendices
Appendices
Slide 56: 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 1,30 10% 1,25 200 -3% 50 5% 1,20 0 -6% 0 0% 1,15 2012 2013 2014 2015 2017 2018 2016* 2019** 2012 2017 2013 2014 2015
Slide 57: Key figures by quarter
Key figures by quarter Net Netsales, sales,EUR EURmillion million Operating Operating profit, profit, EUREUR million million 1 500 Q4 400 Q4 1 000 279 300 59 Q3 266 264 274 Q3 71 55 259 242 284 200 92 69 Q2 222 Q2 55 500 45 91 273 261 246 252 84 71 Q1 100 70 52 262 266 247 241 280 Q1 88 0 80 70 55 8
Slide 58: Key figures
Key figures 1-3/ Change vs. Orion’s key figures 2015 2016 2017 2018 2019 2020 1-3/2019 Net sales, EUR million 1,015.6 1,073.5 1,033.6 977.5 1,051.0 279.9 +16.1% EBITDA 308,3 355,2 323,6 293.9 308.9 98.6 +43.6% Operating profit, EUR million 266.6 314.6 284.1 252.8 252.8 84.4 +53.3% Profit before taxe
Slide 59: Income statement
Income statement Change vs. Formation of profits, EUR million 2015 2016 2017 2018 2019 1-3/2020 1-3/2019 Net sales 1,015.6 1,073.5 1,033.6 977.5 1,051.0 279.9 +16.1% Cost of goods sold -405.8 -421.7 -417.6 -387.9 -417.6 -104.8 +8.5% Gross profit 609.8 651.8 616.0 589.6 633.4 175.1 +21.2% Other opera
Slide 60: Royalties and milestones
Royalties and milestones Includes significant part of EUR 50 million 80 darolutamide collaboration signing fee from Bayer Includes EUR 45 million milestone from Bayer for the first commercial sales of darolutamide in the USA 70 60 5 EUR million 50 39 40 12 51 30 15 53 8 20 5 28 30 1 10 23 23 17 11 0
Slide 61: 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 62: Financial position
Financial position EUR million 3/20 3/19 Change % EUR million 3/20 3/19 Change % Non-current assets total 426.1 417.8 +2.0% Inventories 232.2 220.4 +5.4% Equity total 842.6 606.8 +38.9% Interest-bearing non-current Trade receivables 216.5 178.6 +21.2% liabilities 105.9 5.4 Other receivables 25.0 41.
Slide 63: 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 63
Slide 64: 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 2012 2013 2014 2015 2016 2017 2018 2019 2020 2012 2013 2014 2015 2016 2017 2018 2019 2020 Receivables Receivables Inventories Inventories Short-term non-interest bearing l
Slide 65: 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 66: Easyhaler® - diverse treatment options for asthma and COPD
Easyhaler® - diverse treatment options for asthma and COPD by utilizing 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 67: Orion calendar
Orion calendar Annual General Meeting 6/5/2020 Half-Year Report 1−6/2020 17/7/2020 Interim Report 1−9/2020 21/10/2020
Slide 68: 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