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 2020 3) Research & Development 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, 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 (2020 figures)
Orion at a glance (2020 figures) Net sales Sales by business Sales by market area 1,078 MEUR Operating profit 7% 13% 8% 280 MEUR 39% 8% 29% Personnel 3,311 R&D investments 46% 123 MEUR 34% 16% 6 production sites in Finland Proprietary Products Finland Specialty Products Scandinavia 26 Own sales unit
Slide 7: Financial development between 2008 and 2020
Financial development between 2008 and 2020 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 2020 2008 2009 2010 2011 2012 20
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 2021
Outlook for 2021 Net sales Orion estimates that in 2021 net sales will be slightly lower than in 2020 (net sales in 2020 were EUR 1,078 million). Operating profit Operating profit is estimated to be lower or clearly lower than in 2020 (in 2020 operating profit was EUR 280 million). Investor Presenta
Slide 10: Key assumptions behind the outlook
Key assumptions behind the outlook Net sales Operating profit + Nubeqa® + Nubeqa® + Other growing products + No more depreciation expenses from Parkinson’s franchise - Milestones - Milestones - dexdor® - dexdor® - Simdax® - Simdax® - Animal Health - Normalisation of cost level (without Parkinson’s d
Slide 11: 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 12: 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 13: 2025 Growth target: New Proprietary Products and R&D pipeline as growth drivers
2025 Growth target: New Proprietary Products and R&D pipeline as growth drivers – all units target for organic growth OPPORTUNITIES THREATS/CHALLENGES Darolutamide* ARASENS & ARANOTE Generic competition Easyhaler® tiotropium* Animal Health R&D* Failures in R&D programmes In-licensing and product acq
Slide 14: Key clinical development pipeline
Key clinical development pipeline Phase completed Phase ongoing Project/compound Indication Phase I Phase II Phase III Registration ARASENS / darolutamide 1 Prostate cancer (mHSPC) Phase I Phase II Phase III ARANOTE / darolutamide 1 Prostate cancer (mHSPC) Phase I Phase II Phase III ODM-208 Prostate
Slide 15: Orion had ~72,000 shareholders on 31 December 2020
Orion had ~72,000 shareholders on 31 December 2020 By number of shares By number of votes Households (Finnish 5% 2% retail) 9% 2% 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 In
Slide 16: Largest shareholders by votes and shares on 31 December 2020
Largest shareholders by votes and shares on 31 December 2020 # Shareholder % of votes Number of votes # Shareholder % of shares Number of shares 1 Erkki Etola and companies 6.21 50,200,000 1 Ilmarinen Mutual Pension Insurance Company 2.65 3,735,128 2 Maa- ja vesitekniikan tuki r.y. and companies 5.1
Slide 17: Orion B share performance January 2016 – December 2020
Orion B share performance January 2016 – December 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-1
Slide 18: Highlights in January-December 2020
Highlights in January-December 2020
Slide 19: Strong performance amid the challenges posed by the COVID-19 pandemic
Strong performance amid the challenges posed by the COVID-19 pandemic COVID-19 • Orion was able to secure the continuity of production. • No disruptions in the availability of products or raw materials. • Securing the health and safety of employees and patients in on-going clinical trials was a prio
Slide 20: Key figures 1−12/2020
Key figures 1−12/2020 Net sales Operating profit Operating profit Cash flow per share margin before financial items 1,078 280 26% 1.85 MEUR (1,051) MEUR (253) (24%) EUR (1.68) +3% +11% +10% Investor Presentation © Orion Corporation 20
Slide 21: Development of net sales in 1-12/2020 vs. 1-12/2019
Development of net sales in 1-12/2020 vs. 1-12/2019 11 -7 1,078 31 1,051 14 3 -20 -16 11 * Nubeqa® product sales & royalty ** Proprietary Products and Specialty Products *** Animal Health, Fermion and Contract Manufacturing **** Without Nubeqa® royalties Investor Presentation © Orion Corporation 21
Slide 22: Development of operating profit in 1-12/2020 vs. 1-12/2019
Development of operating profit in 1-12/2020 vs. 1-12/2019 9 -14 25 6 280 -2 3 253 * 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 I
Slide 23: Geographical breakdown and development of net sales
Geographical breakdown and development of net sales 1-12/2020 MEUR 1-12/2020 1-12/2019 13% 400 +10% 29% +2% 8% 350 368 300 334 316 309 250 +0% 200 +5% 150 177 177 -20% 34% 16% 100 135 128 103 50 83 Finland Scandinavia 0 Other Europe North America RoW RoW = Rest of the World Investor Presentation © O
Slide 24: All units showed growth
All units showed growth 1−12/2020 1−12/2019 1-12/2020 MEUR +3% +3% 7% 498 486 8% 500 420 406 400 39% 300 +4% +6% 200 46% 89 86 75 71 100 Proprietary Products 0 Specialty Products Specialty Proprietary Animal Fermion and Animal Health Products Products Health Contract Manufacturing Fermion & CM Inves
Slide 25: TOP 10 products in 1-12/2020
TOP 10 products in 1-12/2020 EUR million vs. 1-12/2019 1. Easyhaler® product portfolio 115 +10% 2. Stalevo®, Comtess®, Comtan® 99 +1% 3. Simdax® 62 -8% 4. dexdor® 55 -3% 5. Dexdomitor®, Domitor®, Domosedan®, Antisedan® 35 -4% 6. Burana® 23 -6% 7. Divina® series 21 +8% 8. Remsima®, Ritemvia®, Amgevit
Slide 26: Proprietary Products
Proprietary Products 6 RION ing well-being Buildi
Slide 27: Nubeqa® and Easyhaler® product portfolio growth drivers
Nubeqa® and Easyhaler® product portfolio growth drivers Proprietary Products MEUR +10% sales split 1-12/2020 140 +1% 115 17% 120 24% 104 99 98 -6% 100 -8% 4% -3% 80 68 73 77 62 60 55 57 +609% 40 15% 17 20 2 27% 0 13% Easyhaler® Parkinson's Simdax® Dexdor® Nubeqa® Others portfolio franchise Parkinson
Slide 28: Easyhaler® product portfolio sales
Easyhaler® product portfolio sales +10% 1-12/2020 Budesonide-formoterol Easyhaler® MEUR 72 (62) +15% 40 1-12/2020 Other Easyhaler® products MEUR 43 (42) +2% 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 2016 2017 2018 2019 2020 Other Budesonide-formoterol Easyhal
Slide 29: Parkinson's franchise sales at similar level to 2019
Parkinson’s franchise sales at similar level to 2019 – strong variation within the year 1-12/2020 Own sales MEUR 48 (46) +6% 50 45 1-12/2020 Deliveries to partners MEUR 50 (52) -3% 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 2016 2017 2018 2019 20
Slide 30: Dexdor® and Simdax® - impact of generic competition starting to show
Dexdor® and Simdax® - impact of generic competition starting to show 1-12/2020 Dexdor® MEUR 55 (57) -3% 1-12/2020 Simdax® MEUR 62 (68) -8% 20 20 15 15 10 10 5 5 0 0 2016 2017 2018 2019 2020 2016 2017 2018 2019 2020 Investor Presentation © Orion Corporation 30
Slide 31: Specialty Products
Specialty Products
Slide 32: Strong generic prescription sales in Scandinavia mitigated the decline due to biosimilars
Strong generic prescription sales in Scandinavia mitigated the decline due to biosimilars MEUR +3% Sales split 1−12/2020 300 280 272 14% 250 200 14% 150 -12% +3% +23% 89 100 78 70 68 71 56% 57 50 16% 0 Finland Scandinavia Eastern RoW Europe & Finland Russia Scandinavia Eastern Europe & Russia 1-12/2
Slide 33: Strong year for Gx prescription drugs even without COVID-19 impact
Strong year for Gx prescription drugs even without COVID-19 impact – biosimilars declined as anticipated MEUR +8% Sales split 1−12/2020 400 358 3% 350 331 300 25% 250 +4% 200 150 122 118 -53% 100 38 50 18 72% 0 Generic Self Care Biosimilars Generic drugs prescription products drugs Self-care product
Slide 34: Specialty Products' sales change vs. 2019
Specialty Products’ sales change vs. 2019 35 40% 30% 25 20% 10% 15 0% EUR million -10% 5 -20% -5 -30% -40% -15 -50% -60% -25 -70% Q1 Q2 Q3 Q4 FY20 Q1 Q2 Q3 Q4 FY20 Gx prescription drugs Self Care Biosimilars Gx prescription drugs Self Care Biosimilars Investor Presentation © Orion Corporation 34
Slide 35: 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 prescription drugs in Finland* The sales of Orion's reference (1−12/2020) priced prescription drugs in Finland MEUR 449 (452) MEUR 110 (108) Market development Orion’s
Slide 36: Orion is strong in home market Finland
Orion is strong in home market Finland Human pharma market in Finland 1−12/2020 Reference Self-care Medicinal and non-medicinal products priced products in hospital and pharmacy channels: EUR 2,903 million prescription Orion market share in MEUR drugs pharmacy 350 316 Orion market share in 300 pharm
Slide 37: Key business targets in 2021
Key business targets in 2021 TARGET STATUS Supporting sales growth and co-promotion in Europe with Bayer Positive outcome from Phase III ARASENS trial Taking phase III ARANOTE trial forward together with Bayer Sales growth ODM-208 Taking the development program forward according to plan Finland Main
Slide 38: Orion's responsibility and COVID-19
Orion’s responsibility and COVID-19 ORION’S RESPONSIBILITY PROGRAM 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 care of the health
Slide 39: Research and development
Research and development
Slide 40: Focus areas of Orion's R&D
Focus areas of Orion’s R&D Proprietary products Animal Health Fermion • Neurological disorders • Orion utilises the • APIs for Orion’s (including rare diseases) R&D of proprietary proprietary products • Oncology products to develop • Generic APIs • Respiratory new medicines for • Contract developmen
Slide 41: Proprietary human pharmaceuticals developed by Orion
Proprietary human pharmaceuticals developed by Orion Fareston® Investor Presentation © Orion Corporation 41
Slide 42: 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 43: Key clinical development pipeline
Key clinical development pipeline Phase completed Phase ongoing Project/compound Indication Phase I Phase II Phase III Registration ARASENS / darolutamide 1 Prostate cancer (mHSPC) Phase I Phase II Phase III ARANOTE / darolutamide 1 Prostate cancer (mHSPC) Phase I Phase II Phase III ODM-208 Prostate
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: ARANOTE trial
ARANOTE trial Primary endpoint Patient Treatment Radiological enrollment Estimated progression- about to start completion in Darolutamide + free survival ~555 patients 2024e ADT (rPFS) expected Investor Presentation © Orion Corporation 45
Slide 46: 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 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: 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 49: 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 50: Sustainability is built into Orion's mission
Sustainability is built into Orion’s mission
Slide 51: Orion's Sustainability Agenda and indicators 2020
Orion’s Sustainability Agenda and indicators 2020 Patient safety and ensuring Responsibility for reliable supply of medications the environment Business ethics and Responsibility for Orionees transparency Customer Greenhouse gas Energy savings Injury rate Code of Conduct complaints GxP* audits emiss
Slide 52: 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 2020 76 (ppm) ORION’S FOCUS ON QUALITY THROUGHOUT THE LIFECYCLE PATIENT R&D RAW MANUFACTURING PACKING DELIVERY SALES PATIENT RECYCLING NEED
Slide 53: Appendices
ae a W Appendices GRIon Building well-being
Slide 54: 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 2019 2016* 2020** 2012 2013 2014 2015
Slide 55: Key figures by quarter
Key figures by quarter Net sales, EUR million Operating profit, EUR million 1200 400 900 279 266 264 274 255 Q4 300 59 Q4 71 34 259 242 284 250 Q3 92 69 55 65 Q3 600 222 200 55 292 45 91 273 261 246 252 Q2 84 71 96 Q2 300 100 70 52 262 266 247 241 280 80 88 70 55 84 0 Q1 0 Q1 16* 17 18 19 20 16* 17
Slide 56: Key figures
Key figures Change Orion’s key figures 2016 2017 2018 2019 2020 vs. 2019 Net sales, EUR million 1,073.5 1,033.6 977.5 1,051.0 1,078.1 +2.6% EBITDA 355,2 323,6 293.9 308.9 336.5 +9.0% Operating profit, EUR million 314.6 284.1 252.8 252.8 280.1 +10.8% Profit before taxes, EUR million 310.9 277.7 248.4
Slide 57: Income statement
Income statement Change vs. Formation of profits, EUR million 2016 2017 2018 2019 2020 2019 Net sales 1,073.5 1,033.6 977.5 1,051.0 1 078.1 +2.6% Cost of goods sold -421.7 -417.6 -387.9 -417.6 -427.0 +2.3% Gross profit 651.8 616.0 589.6 633.4 651.0 +2.8% Other operating income and expenses 24.3 4.9
Slide 58: 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 59: Development of Proprietary Products net sales
Development of Proprietary Products net sales 450 2 17 400 24 Nubeqa® 26 65 61 350 44 56 18 46 26 25 Other 27 20 59 62 300 13 29 47 56 57 68 EUR million 48 25 51 Simdax® 250 35 59 51 64 77 90 115 35 105 Easyhaler® 200 30 45 57 150 18 64 63 Dexdor® 249 20 57 55 206 25 26 13 12 100 170 Precedex® 138 1
Slide 60: Financial position
Financial position EUR million 12/20 12/19 Change % EUR million 12/20 12/19 Change % Non-current assets total 371.8 435.6 -14.6% Inventories 258.1 230.3 +12.1% Equity total 731.3 779.4 -6.2% Interest-bearing non-current Trade receivables 157.4 196.5 -19.9% liabilities 105.5 6.7 Other receivables 33.
Slide 61: 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 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 Investor Presentation © Orion Corporation 61
Slide 62: 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 Jun14 Dec14 Jun15 Dec15 Jun16 Dec16 Jun17 Dec17 Jun18 Dec18 Jun19 Dec19 Dec20 Sep14 Sep15 Sep16 Sep17 Sep18 Sep19 Sep20 Mar14 Mar15 Mar16 Mar17 Mar18 Mar19 Mar20 Jun 20 Ju
Slide 63: 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 64: 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 65: Upcoming events
Upcoming events Annual General Meeting 25/3/2021 Interim Report 1-3/2021 27/4/2021 Capital Markets Day 2021 26/5/2021 Half-Year Financial Report 19/7/2021 Interim Report 1-9/2021 20/10/2021
Slide 66: 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