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: Orion in brief
Orion in brief 3 Investor Presentation © Orion Corporation
Slide 4: Orion at a glance (2022 figures)
Orion at a glance (2022 figures) Sales by business2 Sales by market area2 Net sales EUR 1,341 million (EUR 1,113 million w/o ODM-208 upfront payment1) 13% 6% 1% Operating profit EUR 440 million 9% 37% 29% (EUR 232 million w/o ODM-208 upfront payment impact1) 10% Personnel 3,527 (31 Dec 2022) 47% R&D
Slide 5: New organisational structure as of 1 January 2023
New organisational structure as of 1 January 2023 Main changes – comparable net sales from 2022 for new business divisions will be published later Fermion & Contract Proprietary Products Specialty Products Animal Health Manufacturing Generics & Innovative Medicines Branded Products Animal Health Fer
Slide 6: Financial development from 2008 to 2022
Financial development from 2008 to 2022 1 600 35% 500 35% 250 1 400 30% 450 30% 25% 400 200 1 200 350 25% 20% 1 000 150 EUR million EUR million 300 EUR million 15% 20% 800 250 10% 15% 600 200 100 5% 150 10% 400 0% 100 50 200 -5% 5% 50 0 -10% 0 0% 0 2013 2020 2014 2015 2016 2017 2018 2019 2020 2021 2
Slide 7: Outlook for 2023
Outlook for 2023 Net sales Orion estimates that net sales in 2023 will be slightly higher than in 2022 without the EUR 228 million impact from ODM-208 upfront payment (net sales in 2022 without the impact of the ODM-208 upfront payment were EUR 1,113 million). Operating profit Operating profit is es
Slide 8: Basis for the outlook – key contributors
Basis for the outlook – key contributors Net sales Operating profit Nubeqa® Generic Nubeqa® Operating costs Animal Health competition COGS** Milestones* Milestones* Russia Simdax® and other declining Easyhaler® Pricing products pressure * Excluding ODM-208 upfront payment * Excluding ODM-208 upfront
Slide 9: 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 10: 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 10 Investor Presentatio
Slide 11: Key clinical development pipeline
Key clinical development pipeline Project/compound Indication PHASE I PHASE II PHASE III REGISTRATION ARASENS / darolutamide 1 Prostate cancer (mHSPC) ARANOTE / darolutamide 1 Prostate cancer (mHSPC) ODM-208 2 Prostate cancer (mCRPC) ODM-105 / tasipimidine Psychiatric disorders ODM-111 (NaV 1.8 bloc
Slide 12: Orion had 79,797 shareholders on 31 January 2023
Orion had 79,797 shareholders on 31 January 2023 By number of shares By number of votes Households (Finnish retail) 3% 2% 5% 8% 8% 6% Non-Finnish holders and nominee-registered 6% 38% 13% Private corporations 61% Public sector 10% Non-profit institutions 40% Financial and insurance corporations 12 I
Slide 13: Largest shareholders by votes and shares on 31 January 2023
Largest shareholders by votes and shares on 31 January 2023 # Shareholder % of votes # Shareholder % of shares 1 Erkki Etola and companies 6.39 1 Ilmarinen Mutual Pension Insurance Company 2.41 2 Maa- ja vesitekniikan tuki r.y. and companies 5.29 2 Varma Mutual Pension Insurance Company 2.10 3 Ilmar
Slide 14: Orion B share performance
Share price, EUR 65 60 55 50 45 40 35 30 25 20 31-Dec-22 30-Sep-22 Orion B share price 30-Jun-22 31-Mar-22 31-Dec-21 30-Sep-21 30-Jun-21 31-Mar-21 OMXH-portfolio 31-Dec-20 30-Sep-20 30-Jun-20 31-Mar-20 from January 2016 to January 2023 31-Dec-19 Europe/Pharmaceutical 30-Sep-19 30-Jun-19 31-Mar-19 31
Slide 15: Highlights in January-December 2022
Highlights in January- December 2022 15 Investor Presentation © Orion Corporation
Slide 16: Orion's eventful year laid foundation for future growth
Orion’s eventful year laid foundation for future growth Bayer updated estimate on Acquisition of animal health Nubeqa®’s peak sales potential company VMD A global development and Research focus on commercialisation agreement oncology and pain with MSD on ODM-208 New organizational structure and FDA
Slide 17: Exceptionally high net sales and operating profit
Exceptionally high net sales and operating profit The impact of ODM-208 upfront payment shown in all key figures Cash flow from Operating profit Net sales Operating profit operating activities margin per share MEUR MEUR EUR 1,341 440 33% 3.09 (1,041) +29% (243) +81% (23%) (1.53) +101% w/o ODM-208 up
Slide 18: Net sales bridge FY2021 to FY2022
Net sales bridge FY2021 to FY2022 1 Simdax® & Dexdor® 5 Animal Health and Fermion & Contract Manufacturing 2 Nubeqa® (product sales & royalty) 6 Exchange rates 3 Easyhaler® product portfolio 7 Royalties & milestones (without Nubeqa® royalties) 4 Other Proprietary and Specialty Products 18 Investor P
Slide 19: Operating profit bridge FY2021 to FY2022
Operating profit bridge FY2021 to FY2022 The impact of fx rates varied strongly during the year - negative in Q1 and Q4, positive in Q2 and Q3 1 Product & service sales without sales margin and 4 Milestones & royalties product mix change and exchange rate effect 2 Product sales margin and product mi
Slide 20: Growth in product sales
Growth in product sales +66% 700 644 Sales split +4% 600 1% 521 503 500 5% 7% 416 388 w/o ODM-208 upfront (+7%) 400 39% MEUR 300 200 +35% -8% 48% 99 100 73 75 69 2 8 0 Specialty Products Specialty Proprietary Animal Health Fermion & Other* Proprietary Products Products Products Contract Animal Healt
Slide 21: TOP 10 products in 2022
TOP 10 products in 2022 EUR vs. Product or product portfolio million 1−12/2021 1. Easyhaler® product portfolio 130 +11% 2. Stalevo®, Comtess®, Comtan® 100 +5% 3. Nubeqa® 88 +122% 4. Simdax® 43 -25% 5. Dexdomitor®, Domitor®, Domosedan®, Antisedan® 36 -6% 6. Divina® series 28 +19% 7. Burana® 27 +13% 8
Slide 22: Proprietary Products
Proprietary Products 300 • The impact of ODM-208 upfront payment 265 shown in ‘Others’ 250 • Nubeqa® driving the growth • Fine year for Easyhaler® product portfolio 200 • Timing of partner deliveries explaining the +11% +5% growth in Parkinson’s franchise MEUR 150 130 117 +122% • Expected decline fo
Slide 23: Strong growth for Nubeqa sales booked by Orion
Strong growth for Nubeqa® sales* booked by Orion 40 • Orion is entitled to receive annually tiered royalties on global darolutamide sales. The average annual 35 royalty rate is initially approximately 20% including 30 product sales to Bayer. At first, the average annual royalty rate will be slightly
Slide 24: Specialty Products
Specialty Products 450 350 +1% +4% Sales split by geographic 400 380 384 300 278 289 areas 350 250 300 200 15% MEUR 250 MEUR 150 -2% +13% 200 +11% 15% 100 76 76 81 80 76 150 137 67 123 55% 50 100 0 15% 50 0 Generic Self-care products prescription drugs Finland Scandinavia 1–12/2021 1–12/2022 1–12/20
Slide 25: Overview of the Finnish Pharmaceutical Market
Overview of the Finnish Pharmaceutical Market Price decline of reference priced prescription drugs offset by strong volume growth 1-12/2022 Market Orion Orion’s Orion’s sales split Finland’s share of Orion EUR million market share Group’s total net sales* Total sales of human 3,081 335 33% 33% 11% 2
Slide 26: Animal Health and Fermion & Contract Manufacturing
Animal Health and Fermion & Contract Manufacturing • Animal Health growth due to Animal Health Fermion acquisition of animal health 120 120 +35% company VMD in June 99 -8% 100 100 • Sedatives remain the largest product group in Animal Health 80 73 36 80 75 69 • The decline in Fermion’s reported exte
Slide 27: Research & Development
Research & Development 27 Investor Presentation © Orion Corporation
Slide 28: Proprietary human pharmaceuticals developed by Orion
Proprietary human pharmaceuticals developed by Orion 28 Investor Presentation © Orion Corporation
Slide 29: Main Orion Animal Health Marketing Authorisations
Main Orion Animal Health Marketing Authorisations Geepenil Comforion Benzorion Kefavet 29 Investor Presentation © Orion Corporation
Slide 30: Focus areas of Orion's R&D
Focus areas of Orion’s R&D Medicines for humans Animal Health Fermion • The research focus of • Innovative medicines • APIs for Orion’s in-house Innovative Medicines in • Generic medicines developed medicines oncology and pain • Generic APIs • Orion develops also generic • Contract development medic
Slide 31: 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 32: 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 32 Investor Presentation © Orion Corporation
Slide 33: Key clinical development pipeline
Key clinical development pipeline Project/compound Indication PHASE I PHASE II PHASE III REGISTRATION ARASENS / darolutamide 1 Prostate cancer (mHSPC) ARANOTE / darolutamide 1 Prostate cancer (mHSPC) ODM-208 2 Prostate cancer (mCRPC) ODM-105 / tasipimidine Psychiatric disorders ODM-111 (NaV 1.8 bloc
Slide 34: Orion's key clinical trials with darolutamide
Orion’s key clinical trials with darolutamide Clinical trial and treatment Indication Primary endpoint and results Key secondary endpoints ARAMIS Metastasis free survival darolutamide + ADT nmCRPC prolongation by 22.0 months, Overall survival 31% risk reduction (HR=0.69, p=0.003) 59% risk reduction
Slide 35: ODM-208: CYP11A1 inhibitor for 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 36: Sustainability is built into Orion's mission
Sustainability is built into Orion’s mission 36 Investor Presentation © Orion Corporation
Slide 37: Orion's Sustainability Agenda
Orion’s Sustainability Agenda Patient safety Active work for a Care for well-being Ethics at the core of as a top priority better environment professionals our business Patient safety has been a priority We want to be the We want to take care of We maintain strict ethical for us for a hundred years
Slide 38: Orion's Sustainability Agenda and indicators 2022
Orion’s Sustainability Agenda and indicators 2022 Patient safety as a top priority Active work for a better environment Care for well-being professionals Ethics at the core of our business Customer GxP* audits Greenhouse gas Energy savings Injury rate ABC* training, no. complaints by Orion emissions
Slide 39: Appendices
Appendices 39 Investor Presentation © Orion Corporation
Slide 40: Track record vs. financial objectives
Track record vs. financial objectives Net sales Operating profit Dividend 500 35% 1.60 1 600 35% 450 30% 30% 1.55 1 400 400 25% 1.50 1 200 350 25% 20% 1.45 1 000 300 20% 15% 1.40 250 800 1.35 10% 200 15% 600 1.30 5% 150 10% 400 0% 100 1.25 5% 1.20 200 -5% 50 0 -10% 0 0% 1.15 2020 2012 2013 2014 2015
Slide 41: 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 42: Quarterly net sales by unit (MEUR)
Quarterly net sales by unit (MEUR) Proprietary Products Specialty Products 150 300 100 200 100 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 30 20 20 10 10 0 0 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 2018 2019 2020 2021 2022 201
Slide 43: Parkinson's franchise and Easyhaler product portfolio
Parkinson’s franchise and Easyhaler® product portfolio Parkinson’s franchise Easyhaler® 40 40 35 35 30 30 25 25 MEUR MEUR 20 20 15 15 10 10 5 5 0 0 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 2019 2020 2021 2022 2019 2020 2021 2022 Other Budesonide
Slide 44: Simdax and dexdor
Simdax® and dexdor® Simdax® dexdor® 20 20 15 15 MEUR MEUR 10 10 5 5 0 0 2019 2020 2021 2022 2019 2020 2021 2022 44 Investor Presentation © Orion Corporation
Slide 45: Key figures
Key figures Change vs. Orion’s key figures 2018 2019 2020 2021 2022 2021 Net sales, EUR million 977.5 1,051.0 1,078.1 1,041.0 1,340.6 +28.8% EBITDA 293.9 308.9 336.5 289.1 487.1 +68.5% Operating profit, EUR million 252.8 252.8 280.1 243.3 439.6 +80.7% Profit before taxes, EUR million 248.4 250.8 278
Slide 46: Income statement
Income statement Change vs. Formation of profits, EUR million 2018 2019 2020 2021 2022 2021 Net sales 977.5 1,051.0 1,078.1 1,041.0 1,340.6 +28.8% Cost of goods sold -387.9 -417.6 -434.4 -447.5 -491.7 +9.9% Gross profit 589.6 633.4 643.7 593.5 848.9 +43.0% Other operating income and expenses 5.5 2.2
Slide 47: Royalties and milestones
Royalties and milestones Includes EUR 228 million upfront payment from MSD regarding ODM-208 collaboration agreement 300 Includes significant part of EUR 50 million 250 darolutamide collaboration signing fee from Bayer 200 Includes EUR 28 million milestones from Bayer for the EUR million first comme
Slide 48: Development of Proprietary Products net sales
Development of Proprietary Products net sales 650 600 88 550 Nubeqa® 500 450 Other 2 17 256 400 24 EUR million 26 65 61 39 Simdax® 350 44 56 18 46 26 25 31 27 20 59 62 300 13 29 47 56 57 68 25 51 57 43 Easyhaler® 48 250 35 59 51 64 77 90 115 35 105 200 117 130 Dexdor® 30 45 57 150 18 64 63 249 20 57
Slide 49: Financial position
Financial position EUR million 12/22 12/21 Change % EUR million 12/22 12/21 Change % Non-current assets total 624.9 423.7 +47.5% Inventories 315.6 265.2 +19.0% Equity total 908.1 747.9 +21.4% Interest-bearing non-current Trade receivables 180.7 174.8 +3.4% liabilities 196.8 104.7 +88.0% Other receiv
Slide 50: Development of capital expenditure
Development of capital expenditure 160 140 120 100 EUR million 80 60 40 20 0 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 Property, plant and equipment Intangible assets Depreciation, amortisation and impairment 50 Investor Presentation © Orion Corporation
Slide 51: 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 Mar16 Mar17 Mar18 Mar19 Mar20 Mar21 Mar22 Jun16 Jun17 Jun18 Jun19 Jun21 Jun22 Dec15 Dec16 Sep17 Dec17 Dec18 Dec19 Jun 20 Dec20 Dec21 Dec22 Sep15 Sep16 Sep18 Sep19 Sep20 Se
Slide 52: 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% 0.20 0.12 105% 1.
Slide 53: 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 54: Upcoming events
Upcoming events 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 26/10/202 54 Investor Presentation © Orion Corporation
Slide 55: Save the date: Orion Capital Markets Day May 2023
Save the date Orion Capital Markets Day on 25 May 2023 55 Investor Presentation © Orion Corporation