Orion Oyj Class A · OMXHEX:ORNAV
Orion Oyj Class A — Investor Presentation (April 2021)
65 slides from Orion Oyj Class A's investor presentation, April 2021
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 1-3/2021 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 (provided on 9 February 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 2
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 80,990 shareholders on 31 March 2021
Orion had 80,990 shareholders on 31 March 2021 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% 41% Non-profit institutions Financial and insurance corporations Invest
Slide 16: Largest shareholders by votes and shares on 31 March 2021
Largest shareholders by votes and shares on 31 March 2021 # Shareholder % of votes Number of votes # Shareholder % of shares Number of shares 1 Erkki Etola and companies 6.22 50,200,000 1 Ilmarinen Mutual Pension Insurance Company 2.81 3,958,305 2 Maa- ja vesitekniikan tuki r.y. and companies 5.16 4
Slide 17: Orion B share performance January 2016 – March 2021
Orion B share performance January 2016 – March 2021 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 18: Highlights in January-March 2021
Highlights in January-March 2021
Slide 19: Strong start for the year with exceptional circumstances continuing
Strong start for the year with exceptional circumstances continuing Net sales & • Additional demand caused by the COVID-19 pandemic had a material operating profit improving impact on net sales and operating profit in the comparison period. • Due to the pandemic, demand of certain products is still
Slide 20: Key figures 1−3/2021
Key figures 1−3/2021 Net sales Operating profit Operating profit Cash flow per share margin before financial items 269 75 28% 0.19 MEUR (280) MEUR (84) (30%) EUR (0.34) -4% -11% -43% Investor Presentation © Orion Corporation 20
Slide 21: Development of net sales in 1-3/2021 vs. 1-3/2020
Development of net sales in 1-3/2021 vs. 1-3/2020 280 -9 -4 4 -5 -2 -1 3 269 3 * 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 1-3/2021 vs. 1-3/2020
Development of operating profit in 1-3/2021 vs. 1-3/2020 84 -8 -16 12 75 2 3 -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 product mix change but without exchange rate effect Inve
Slide 23: Geographical breakdown and development of net sales
Geographical breakdown and development of net sales 1-3/2021 MEUR 1-3/2021 1-3/2020 14% 120 28% +8% 10% 100 -12% 94 80 84 87 74 -28% 60 +7% 40 51 +18% 13% 37 38 36 35% 20 26 22 Finland Scandinavia 0 Other Europe North America RoW RoW = Rest of the World Investor Presentation © Orion Corporation 23
Slide 24: Net sales were at a good level but declined from strong comparison period
Net sales were at a good level but declined from strong comparison period 1−3/2021 1−3/2020 1-3/2021 MEUR -8 % 8% 160 -7% 135 7% 140 124 120 104 111 39% 100 80 +42% -17% 60 46% 40 23 21 19 15 20 Proprietary Products 0 Specialty Products Specialty Proprietary Animal Fermion and Animal Health Products
Slide 25: TOP 10 products in 1-3/2021
TOP 10 products in 1-3/2021 EUR million vs. 1-3/2020 1. Stalevo®, Comtess®, Comtan® 29 +4% 2. Easyhaler® product portfolio 26 -25% 3. Simdax® 15 -25% 4. dexdor® 12 -27% 5. Dexdomitor®, Domitor®, Domosedan®, Antisedan® 10 +8% 6. Nubeqa® 8 +102% 7. Solomet® 6 +43% 8. Divina® series 6 -2% 9. Burana® 5
Slide 26: Proprietary Products
Proprietary Products 6 RION ing well-being Buildi
Slide 27: Pandemic has a strong impact on demand for Easyhaler® products
Pandemic has a strong impact on demand for Easyhaler® products Proprietary Products MEUR -25% sales split 1-3/2021 40 +4% 35 13% 35 29 28 8% 28% 30 26 -25% -27% +57% 25 19 20 17 15 +102% 14 15 12 9 14% 10 8 4 5 12% 25% 0 Easyhaler® Parkinson's Simdax® Dexdor® Nubeqa® Others portfolio franchise Parki
Slide 28: Easyhaler® product portfolio sales -25%
Easyhaler® product portfolio sales -25% 1-3/2021 Budesonide-formoterol Easyhaler® MEUR 16 (20) -21% 40 1-3/2021 Other Easyhaler® products MEUR 10 (14) -31% 35 30 Sales, MEUR 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 2017 2018 2019 2020 2021 Other Budesonide-formoter
Slide 29: Parkinson's franchise sales +4%
Parkinson’s franchise sales +4% 1-3/2021 Own sales MEUR 14 (13) +4% 40 35 1-3/2021 Deliveries to partners MEUR 16 (15) +4% 30 Sales, MEUR 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 2017 2018 2019 2020 2021 Orion own sales Deliveries to partners Investor Presentation
Slide 30: Dexdor® and Simdax® - impact of generic competition starting to show
Dexdor® and Simdax® - impact of generic competition starting to show 1-3/2021 Dexdor® MEUR 12 (17) -27% 1-3/2021 Simdax® MEUR 15 (19) -25% 20 20 15 15 10 10 5 5 0 0 2017 2018 2019 2020 2021 2017 2018 2019 2020 2021 Investor Presentation © Orion Corporation 30
Slide 31: Specialty Products
Specialty Products
Slide 32: Good quarter for Specialty Products even though net sales declined
Good quarter for Specialty Products even though net sales declined from strong Q1 2020 -12% MEUR Sales split 1−3/2021 80 74 70 65 14% 60 50 -26% +3% +23% 18% 40 30 26 19 22 21 52% 17 20 14 10 0 16% Finland Scandinavia Eastern RoW Europe & Finland Russia Scandinavia Eastern Europe & Russia 1-3/2021 1
Slide 33: Good quarter for Specialty Products even though net sales declined
Good quarter for Specialty Products even though net sales declined from strong Q1 2020 MEUR Sales split 1−3/2021 -7% 120 99 100 92 25% 80 -13% 60 36 40 31 20 0 75% Generic Self Care products prescription drugs Generic drugs Self-care products 1-3/2021 1−3/2020 Investor Presentation © Orion Corporati
Slide 34: In Finland, Orion's reference priced prescription drugs developed better than the market
In Finland, Orion’s reference priced prescription drugs developed better than the market The market for reference priced prescription drugs in Finland* The sales of Orion's reference (1−3/2021) priced prescription drugs in Finland MEUR 101(113) MEUR 25 (27) Market development Orion’s development -10
Slide 35: Orion is strong in home market Finland
Orion is strong in home market Finland Human pharma market in Finland 1−3/2021 Reference Self-care Medicinal and non-medicinal products priced products in hospital and pharmacy channels: EUR 698 million prescription Orion market share in MEUR drugs pharmacy 80 75 Orion market share in 70 25 pharmacy
Slide 36: Key business targets in 2021
Key business targets in 2021 STATUS on TARGET 31 Mar 2021 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 pl
Slide 37: Orion committed to achieving carbon neutrality in its own operations by 2030
Orion committed to achieving carbon neutrality in its own operations by 2030 – steps towards the target Identifying climate impacts Reducing emissions Compensation Consistent reporting (scope 1 & 2) since 2009 Systematic steps towards the target The remaining carbon (Scope 1 & 2) footprint necessary
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 • 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 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: 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 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 2021e of docetaxel Secondary endpoints: Time to castration resistanc
Slide 44: 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 44
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: 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: 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 48: 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 49: Sustainability is built into Orion's mission
Sustainability is built into Orion’s mission
Slide 50: 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 51: 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 52: Appendices
ae a W Appendices GRIon Building well-being
Slide 53: 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 54: Key figures by quarter
Key figures by quarter Net sales, EUR million Operating profit, EUR million 1200 300 71 34 900 266 264 274 255 Q4 69 55 65 Q4 200 55 242 284 250 Q3 45 Q3 600 222 91 96 292 71 70 261 246 252 Q2 100 52 Q2 300 266 247 241 280 269 88 70 55 84 75 0 Q1 0 Q1 17 18 19 20 21 17 18 19 20 21 Basic earnings per
Slide 55: Key figures
Key figures 1-3/ Change vs. Orion’s key figures 2017 2018 2019 2020 2021 1-3/2020 Net sales, EUR million 1,033.6 977.5 1,051.0 1,078.1 268.7 -4.0% EBITDA 323,6 293.9 308.9 336.5 86.0 -12.8% Operating profit, EUR million 284.1 252.8 252.8 280.1 75.0 -11.1% Profit before taxes, EUR million 277.7 248.4
Slide 56: Income statement
Income statement Change vs. Formation of profits, EUR million 2017 2018 2019 2020 1-3/2021 1-3/2020 Net sales 1,033.6 977.5 1,051.0 1 078.1 268.7 -4.0% Cost of goods sold -417.6 -387.9 -417.6 -427.0 -114.7 +7.7% Gross profit 616.0 589.6 633.4 651.0 153.9 -11.2% Other operating income and expenses 4.
Slide 57: 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 70 first commercial sales of darolutamide in EU and JPN 60 Includes EUR 45 million milestone from Bayer for the 5 first comm
Slide 58: 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 59: Financial position
Financial position EUR million 3/21 3/20 Change % EUR million 3/21 3/20 Change % Non-current assets total 406.5 426.1 -4.6% Inventories 255.4 232.2 +10.0% Equity total 628.9 842.6 -25.4% Interest-bearing non-current Trade receivables 166.9 216.5 -22.9% liabilities 105.0 105.9 -0.9% Other receivables
Slide 60: Development of capital expenditure
Development of capital expenditure Orion capex, EUR million 90 80 70 60 50 40 30 20 10 0 Property, plant and equipment Intangible assets Depreciation, amortisation and impairment Investor Presentation © Orion Corporation 60
Slide 61: 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 Mar21 Jun
Slide 62: 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 63: 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 64: Upcoming events
Upcoming events Capital Markets Day 2021 26/5/2021 Half-Year Financial Report 19/7/2021 Interim Report 1-9/2021 20/10/2021
Slide 65: 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