Orion Oyj Class A · OMXHEX:ORNAV
Orion Oyj Class A — Q3 2022 Earnings Presentation
68 slides from Orion Oyj Class A's earnings presentation, 2022
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 1-9/2022 3) Research & Development 4) Sustainability 5) Appendices 6) Financial calendar Investor Presentation © Orion Corporation 3
Slide 4: Orion in brief
Orion in brief ORION Building well-being
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 (2021 figures)
Orion at a glance (2021 figures) Sales by business Sales by market area Net sales 1,041 MEUR 7% 13% Operating profit 243 MEUR 7% 30% 37% 9% Personnel 3,355 (31 Dec 2021) 49% R&D investments 118 MEUR 34% 14% 7 production sites Proprietary Products Finland Specialty Products Scandinavia Other Europe O
Slide 7: Financial development between 2008 and 2021
Financial development between 2008 and 2021 Net sales Operating profit 1 200 12% 350 35% 1 000 9% 300 30% 250 25% 800 6% EUR million EUR million 200 20% 600 3% 150 15% 400 0% 100 10% 200 -3% 50 5% 0 -6% 0 0% 2009 2008 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2008 2009 2010 2011 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 2022
Outlook for 2022 (published on 13 July 2022) Orion estimates that in 2022 net sales will be Net sales clearly higher than in 2021 (in 2021 net sales were EUR 1,041 million). Operating profit is estimated to be Operating clearly higher than in 2021 profit (in 2021 operating profit was EUR 243 million
Slide 10: Key assumptions impacting the outlook
Key assumptions impacting the outlook Operating Net sales profit + Upfront + Upfront payment payment + Nubeqa® + Nubeqa® - Simdax® + VMD acquisition - dexdor® - Simdax® - Cost inflation - dexdor® - Price competition in generics - Sales & marketing expenses Investor Presentation © Orion Corporation 1
Slide 11: Orion's financial objectives
Orion’s financial objectives Growing net sales more rapidly than growth of the pharmaceuticals Keeping the equity ratio at market. Achievement of this objective least 50%. requires continuous investment in development of the product portfolio. Maintaining profitability at a good Distributing an annu
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: Growth drivers for Orion
Growth drivers for Orion 2022−2025 2025 → ODM-208* ODM-105* ODM-111* Ganaxolone* In-licensing of new products Possible M&As (product or company acquisitions) Geographical expansion * Development phase molecule – requires success in clinical development and regulatory approval Investor Presentation ©
Slide 14: Key clinical development pipeline
Key clinical development pipeline Project/compound Indication Phase I Phase II Phase III Registration ARASENS / darolutamide 1 Prostate cancer (mHSPC) Phase I Phase II Phase III Registration ARANOTE / darolutamide 1 Prostate cancer (mHSPC) Phase I Phase II Phase III ODM-208 2 Prostate cancer (mCRPC)
Slide 15: Orion had 79,631 shareholders on 30 September 2022
Orion had 79,631 shareholders on 30 September 2022 By number of shares By number of votes Households (Finnish 5% 3% retail) 8% 2% 7% 6% Non-Finnish holders and nominee-registered 6% 39% Private corporations 13% 61% Public sector 10% Non-profit institutions 40% Financial and insurance corporations In
Slide 16: Largest shareholders by votes and shares on 30 September 2022
Largest shareholders by votes and shares on 30 September 2022 # Shareholder % of votes Number of votes # Shareholder % of shares Number of shares 1 Erkki Etola and companies 6.35 50,325,000 1 Ilmarinen Mutual Pension Insurance Company 2.50 3,520,629 2 Maa- ja vesitekniikan tuki r.y. and companies 5.
Slide 17: Orion B share performance January 2016 – September 2022
17 Share price, EUR 65 40 60 55 50 45 35 30 25 20 Orion B share price 30-Sep-22 30-Jun-22 Orion B share performance January 2016 – September 2022 31-Mar-22 Investor Presentation © Orion Corporation 31-Dec-21 30-Sep-21 30-Jun-21 OMXH-portfolio 31-Mar-21 31-Dec-20 30-Sep-20 30-Jun-20 31-Mar-20 31-Dec-
Slide 18: Acquisition of VMD - Orion Animal Health and VMD complement each other
Acquisition of VMD - Orion Animal Health and VMD complement each other – no overlaps Net sales in 2021 EUR 73 million EUR 61 million Personnel 72 181 Manufacturing sites 2 (Espoo, Turku) 1 (Arques) Manufacturing & Companion Food producing R&D focus animals animals Net sales split VMD Orion Animal He
Slide 19: Highlights in January−September 2022
Highlights in January−September 2022
Slide 20: An eventful year for Orion so far
An eventful year for Orion so far Bayer updated estimate on Nubeqa’s peak Acquisition of animal health company VMD sales potential (Inovet) Research focus on oncology and pain Orion and MSD announced a global development and commercialisation agreement for ODM-208 Liisa Hurme appointed as President
Slide 21: Sales developed well – milestone having material impact on net sales and operating profit
Sales developed well – milestone having material impact on net sales and operating profit Orion • Orion and MSD announced a global development and commercialisation agreement for ODM-208 - Upfront payment of USD 290 million of which EUR 228 million recognized in Q3 2022 net sales and operating profi
Slide 22: Key figures 1−9/2022 – upfront payment impacts all figures
Key figures 1−9/2022 – upfront payment impacts all figures Net sales Operating profit Operating profit Cash flow from margin operating activities per share 1,046 399 38% 3.05 MEUR (765) MEUR (203) (27%) EUR (0.99) +37% +96% +208% Investor Presentation © Orion Corporation 22
Slide 23: Development of net sales in 1−9/2022 vs. 1−9/2021
Development of net sales in 1−9/2022 vs. 1−9/2021 231 1,046 20 11 11 3 765 -21 27 * Nubeqa® product sales & royalty ** Proprietary Products and Specialty Products *** Animal Health, Fermion and Contract Manufacturing **** Without Nubeqa® royalties The figures in the chart are rounded, which is why t
Slide 24: Development of operating profit in 1−9/2022 vs. 1−9/2021
Development of operating profit in 1−9/2022 vs. 1−9/2021 236 -57 -45 -2 45 399 18 203 * 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 effec
Slide 25: Geographical breakdown and development of net sales
Geographical breakdown and development of net sales 1−9/2022 1−9/2021 1−9/2022 10% 23% 350 +13% +372% 300 +3% 298 299 250 263 29% 200 230 237 MEUR 10% -1% +5% 150 100 105 104 102 107 28% 50 63 Finland Scandinavia 0 Other Europe North America RoW RoW = Rest of the World Investor Presentation © Orion
Slide 26: Animal Health growing strongly due to Inovet acquisition
Animal Health growing strongly due to Inovet acquisition 1−9/2021 1−9/2022 1−9/2022 600 +85% 5% 1% 500 530 +5% 6% 400 368 386 MEUR 300 51% 287 37% 200 +23% -4% +592% 100 Proprietary Products 53 65 55 53 2 11 0 Specialty Products Specialty Proprietary Animal Health Fermion & Other* Animal Health Prod
Slide 27: Top products in 1−9/2022
TOP 10 products in 1−9/2022 EUR million vs. 1−9/2021 1. Easyhaler® product portfolio 94 +13% 2. Stalevo®, Comtess®, Comtan® 79 +7% 3. Nubeqa® 53 +101% 4. Simdax® 33 -22% 5. Dexdomitor®, Domitor®, Domosedan®, Antisedan® 28 +6% 6. Divina® series 20 +19% 7. Burana® 19 +14% 8. Solomet® 18 +15% 9. dexdor
Slide 28: Proprietary Products
Proprietary Products GRION Building well-being
Slide 29: Nubeqa and ODM-208 milestone driving the growth
Nubeqa® and ODM-208 milestone driving the growth Proprietary Products sales split 1−9/2022 +650% +13% 256 15% +7% 94 48% 83 79 +101% MEUR 74 -22% 18% 53 -44% 43 33 34 3% 26 27 15 6% 10% Easyhaler® Parkinson's Nubeqa® Simdax® Dexdor® Others* portfolio franchise Parkinson's Easyhaler® Dexdor® Simdax®
Slide 30: Nubeqa sales booked by Orion showing strong growth
Nubeqa® sales* booked by Orion showing strong growth – vary as expected from quarter to quarter 25 +101% 20 53 15 MEUR 10 MEUR 5 26 0 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 2019 2020 2021 2022 YTD9'21 YTD9'22 Royalty Product sales to Bayer * Orion’s sales to Bayer for commercial use + royalties from
Slide 31: Easyhaler continued on a growth path (+13%)
Easyhaler® continued on a growth path (+13%) 40 35 60 30 52 25 MEUR 20 MEUR +14% 15 10 5 31 34 0 +11% Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 2019 2020 2021 2022 YTD9'21 YTD9'22 Other Budesonide-formoterol Easyhaler® Investor Presentation © Orion Corporation 31
Slide 32: Sales of Parkinson's franchise +7%
Sales of Parkinson's franchise +7% 40 35 30 79 25 74 MEUR 20 MEUR 15 +7% 10 5 0 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 YTD9'21 YTD9'22 2019 2020 2021 2022 Investor Presentation © Orion Corporation 32
Slide 33: Dexdor and Simdax - declining as expected
Dexdor® and Simdax® - declining as expected Dexdor® Simdax® 20 -44% 20 -22% 15 27 15 43 MEUR MEUR 10 10 33 MEUR MEUR 15 5 5 0 0 YTD9'21YTD9'22 YTD9'21YTD9'22 2019 2020 2021 2022 2019 2020 2021 2022 Investor Presentation © Orion Corporation 33
Slide 34: Specialty Products
Specialty Products GRION Building well-being
Slide 35: Geographical split of net sales
Geographical split of net sales Sales split 1−9/2022 250 +3% 15% 200 202 209 150 16% MEUR 100 +1% +3% +20% 54% 50 57 58 61 62 57 48 15% 0 Finland Scandinavia Eastern RoW Finland Europe Scandinavia Eastern Europe 1−9/2021 1−9/2022 Rest of the World (RoW) Investor Presentation © Orion Corporation 35
Slide 36: Growth in both product segments
Growth in both product segments +3% Sales split 1−9/2022 300 276 283 250 27% 200 MEUR 150 +12% 100 92 103 50 0 73% Generic Self Care prescription drugs products Generic drugs Self-care products 1−9/2021 1−9/2022 Investor Presentation © Orion Corporation 36
Slide 37: In Finland, Orion's reference priced prescription drugs developed clearly better than the market
In Finland, Orion’s reference priced prescription drugs developed clearly better than the market The market for reference priced The sales of Orion's reference prescription drugs in Finland* priced prescription drugs in (1−9/2022) Finland MEUR 330 (353) MEUR 80 (72) Market development Orion’s develo
Slide 38: Orion is strong in home market Finland
Orion is strong in home market Finland Human pharma market in Finland 1−9/2022 Reference Self-care Medicinal and non-medicinal products priced products in hospital and pharmacy channels: EUR 2,254 million (+4%) prescription Orion market share in drugs pharmacy 300 Orion market share in 250 242 pharm
Slide 39: Energy risk management in Orion
Energy risk management in Orion Orion is targeting carbon neutrality in its own operations by 2030 Systematic progress towards 2030 carbon neutrality target. For the short term, emissions may increase and the share of renewable energy may decrease. Ensuring the availability of energy for own product
Slide 40: Focus areas in 2022
Focus areas in 2022 Status on 30 TARGET KPIs 2022 September 2022 Increasing the sales of Significant increase in sales of Nubeqa® booked by Orion the current product portfolio Easyhaler® product portfolio sales increase by more than 5% In-licensing of new products Portfolio enhancement through produ
Slide 41: Research and development
Research and development
Slide 42: Proprietary human pharmaceuticals developed by Orion
Proprietary human pharmaceuticals developed by Orion Fareston® Investor Presentation © Orion Corporation 42
Slide 43: Main Orion Animal Health Marketing Authorisations
Main Orion Animal Health Marketing Authorisations Geepenil Comforion Benzorion Kefavet Investor Presentation © Orion Corporation 43
Slide 44: Focus areas of Orion's R&D
Focus areas of Orion’s R&D Medicines for humans Animal Health Fermion • In Proprietary Products the • Orion utilises the • APIs for Orion’s research focus in oncology R&D of proprietary proprietary products and pain products to develop • Generic APIs • Orion develops also generic new medicines for •
Slide 45: 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 46: Research Areas in Orion's R&D
Research Areas in Orion’s R&D PAIN ONCOLOGY Ion channels and neuro- Immuno-Oncology immune interaction • FiCAR T-cell therapy • 2nd generation immune- checkpoint inhibitors Cancer genomics and Cell signalling Antibody drug conjugates Investor Presentation © Orion Corporation 46
Slide 47: Key clinical development pipeline
Key clinical development pipeline Project/compound Indication Phase I Phase II Phase III Registration ARASENS / darolutamide 1 Prostate cancer (mHSPC) Phase I Phase II Phase III Registration ARANOTE / darolutamide 1 Prostate cancer (mHSPC) Phase I Phase II Phase III ODM-208 2 Prostate cancer (mCRPC)
Slide 48: Orion's key clinical trials with darolutamide
Orion’s key clinical trials with darolutamide Clinical trial and Indication Primary endpoint and results Key secondary endpoints treatment ARAMIS Metastasis free survival Overall survival darolutamide + ADT nmCRPC prolongation by 22.0 months, 31% risk reduction (HR=0.69, p=0.003) 59% risk reduction
Slide 49: Global prostate cancer estimates (GLOBOCAN 2020)
Global prostate cancer estimates (GLOBOCAN 2020) 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 21.4 375,000 4 650+ million men died from Mainly affects men diagnosed with the disease over 50, the risk prostate ca
Slide 50: ODM-208: CYP11A1 inhibitor to treat mCRPC
ODM-208: CYP11A1 inhibitor to treat patients with metastatic castration-resistant prostate cancer (mCRPC) ODM-208 CYPIDES Phase I Target population: patients with prostate cancer that has become resistant to the standard hormonal treatments. 32% of the patients achieved a First–in–class oral molecul
Slide 51: Sustainability is built into Orion's mission
Sustainability is built into Orion’s mission
Slide 52: Orion's Sustainability Agenda
Orion’s Sustainability Agenda Patient safety Active work for a Care for well-being Ethics at the core as a top priority better environment professionals of our business Patient safety has been a We want to be the We want to take care of We maintain strict ethical priority for us for a hundred enviro
Slide 53: Orion's Sustainability Agenda and indicators 2021
Orion’s Sustainability Agenda and indicators 2021 Active work for a Patient safety as a top priority better environment Care for well-being professionals Ethics at the core of our business Customer Greenhouse gas Energy savings Injury rate Code of Conduct complaints GxP* audits emissions target set
Slide 54: Appendices
ae a W Appendices GRIon Building well-being
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* 2018 2012 2013 2014 2015 2017 2019 2020 2021 2014 2012 2013 2
Slide 56: Net sales and operating profit by quarter (MEUR)
Net sales and operating profit by quarter (MEUR) Net sales Operating profit 600 300 500 250 400 200 300 150 200 100 100 50 0 0 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 2018 247 246 222 264 2018 70 70 45 69 2019 241 252 284 274 2019 55 52 91 55 2020 280 292 250 255 2020 84 96 65 34 2021 269 255 241 277 2021 75 71 57
Slide 57: Quarterly net sales by unit (MEUR)
Quarterly net sales by unit (MEUR) Proprietary Products Specialty Products 150 300 200 100 100 50 0 0 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 2018 2019 2020 2021 2022 2018 2019 2020 2021 2022 Animal Health Fermion & Contract Manufacturing 40 30 20 20 10 0 0 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 2018 2019 2020 2021 2022 2018 2019
Slide 58: Key figures
Key figures Change vs. Orion’s key figures 2018 2019 2020 2021 YTD9’22 YTD9’21 Net sales, EUR million 977.5 1,051.0 1,078.1 1,041.0 1,046.1 +36.8% EBITDA 293.9 308.9 336.5 289.1 433.9 +83.5% Operating profit, EUR million 252.8 252.8 280.1 243.3 398.9 +96.1% Profit before taxes, EUR million 248.4 250
Slide 59: Income statement
Income statement Change vs. Formation of profits, EUR million 2018 2019 2020 2021 YTD9’22 YTD9’21 Net sales 977.5 1,051.0 1,078.1 1,041.0 1,046.1 +36,8 % Cost of goods sold -387.9 -417.6 -434.4 -447.5 -352.4 +8,6 % Gross profit 589.6 633.4 643.7 593.5 693.7 +57,7 % Other operating income and expense
Slide 60: Royalties and milestones
Royalties and milestones Includes significant part of EUR 50 million Includes EUR 228 million upfront payment from MSD 120 darolutamide collaboration signing fee from Bayer regarding ODM-208 collaboration agreement 100 Includes EUR 28 million milestones from Bayer for the first commercial sales of d
Slide 61: Development of Proprietary Products net sales
Development of Proprietary Products net sales 450 2 17 400 24 Nubeqa® 26 65 61 39 350 44 56 18 46 26 25 31 Other 27 20 59 62 300 13 29 47 56 57 68 57 EUR million 48 25 51 Simdax® 250 35 59 51 64 77 90 115 35 105 Easyhaler® 200 117 30 45 57 150 18 64 63 Dexdor® 249 20 57 55 37 206 25 26 13 12 100 11
Slide 62: Financial position
Financial position EUR million 9/22 9/21 Change % EUR million 9/22 9/21 Change % Non-current assets total 688.1 453.4 +51.7% Inventories 309.1 272.6 +13.4% Equity total 971.8 743.1 +30.8% Interest-bearing non-current Trade receivables 172.1 147.2 +16.9% liabilities 197.9 104.7 +88.9% Other receivabl
Slide 63: Development of capital expenditure
Development of capital expenditure 90 80 70 60 EUR million 50 40 30 20 10 0 Property, plant and equipment Intangible assets Depreciation, amortisation and impairment 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 Sep15 Sep16 Sep17 Sep18 Sep19 Sep20 Sep21 Sep22 Jun15 Jun16 Jun17 Jun18 Jun19 Jun21 Jun22 Jun 20 Mar16 Mar17 Mar18 Mar19 Mar20 Mar21 Mar22 Dec15 Dec16 Dec17 Dec18 Dec19 De
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 1,75 110% 0.12 0.20 105% 1,
Slide 66: Easyhaler - One device with several therapy options
Easyhaler® - One device with several therapy options for patients with asthma or Chronic Obstructive Pulmonary Disease (COPD) ● Easyhaler® portfolio consists of 6 dry-powder inhaler (DPI) products with several well-known generic active substances for the treatment of patients with asthma or COPD. ●
Slide 67: Upcoming events
Upcoming events Financial Statement Release for 2022 9/2/2023 AGM planned to be held 22/3/2023 Interim Report 1-3/2023 27/4/2023 Half-Year Financial Report 17/7/2023 Interim Report 1-9/2023 26/10/2023
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 Paula Bäck Executive Assistant (Investor meeting requests) paula.back@orion.fi +358 10 426 3011 www.orion.fi/EN/Investors twitter.com/OrionC